<rss xmlns:a10="http://www.w3.org/2005/Atom" version="2.0"><channel><title>News &amp; Perspectives | Arnold &amp; Porter</title><link>https://www.arnoldporter.com/en/rss/perspectives</link><description>News &amp; Perspectives | Arnold &amp; Porter</description><language>en</language><item><guid isPermaLink="false">{8956175D-AA42-4043-8E64-2A6177323F9C}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-advises-volaris-group-on-acquisition-of-l5-networks</link><title>Arnold &amp; Porter Advises Volaris Group on Acquisition of L5 Networks</title><description>Arnold &amp;amp; Porter recently advised Volaris Group in its acquisition of L5 Networks, a Brazilian provider of cloud-based corporate communications solutions and omnichannel and corporate collaboration platforms.</description><pubDate>Tue, 25 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt; Arnold &amp;amp; Porter recently advised Volaris Group in its acquisition of L5 Networks, a Brazilian provider of cloud-based corporate communications solutions and omnichannel and corporate collaboration platforms. Volaris Group is an operating group of Constellation Software Inc., a Canadian-based company that acquires and develops technology companies serving vertical markets.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Mergers &amp;amp; Acquisitions partner Carlos Lobo.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{529F2FC2-CC31-47B7-A6E6-F8E994C57B74}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-strengthens-financial-services-bench-with-addition-of-partner-brendan-clegg</link><title>Arnold &amp; Porter Strengthens Financial Services Bench with Addition of Partner Brendan Clegg in Washington, D.C.</title><description>&lt;strong&gt;WASHINGTON, D.C., August 24, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Brendan Clegg has joined the Financial Services practice as a partner resident in the firm&amp;rsquo;s Washington, D.C. office. Brendan joins the firm with nearly 15 years of experience in the public and private sectors, including as enforcement counsel at the Office of the Comptroller of the Currency (OCC).</description><pubDate>Mon, 24 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;WASHINGTON, D.C., August 24, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Brendan Clegg has joined the Financial Services practice as a partner resident in the firm&amp;rsquo;s Washington, D.C. office. Brendan joins the firm with nearly 15 years of experience in the public and private sectors, including as enforcement counsel at the Office of the Comptroller of the Currency (OCC).&lt;/p&gt;
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&lt;p&gt;Brendan represents national and state-chartered banks and financial services providers in a variety of regulatory, transactional, licensing, and enforcement matters. He has advised clients on matters before the OCC, Federal Deposit Insurance Corporation, Federal Reserve Board, Consumer Financial Protection Bureau, Financial Crimes Enforcement Network, National Credit Union Administration, and state banking regulators and attorneys general. Brendan assists clients in addressing supervisory findings and navigating regulatory examinations conducted by these agencies. In the past few years, he has advised banks and other financial institution clients on numerous corporate transactions, including various M&amp;amp;A deals. He also represents banks and non-banks and their directors and officers in enforcement actions, administrative proceedings, and investigations. Brendan regularly counsels clients on consumer compliance, anti-money laundering, safety and soundness, risk management, and corporate governance issues.&lt;/p&gt;
&lt;p&gt;Kevin Toomey, chair of Arnold &amp;amp; Porter&amp;rsquo;s Financial Services practice group, said: &amp;ldquo;Brendan&amp;rsquo;s sophisticated expertise across regulatory, transactional, and enforcement matters will be invaluable in serving the needs of our clients.&amp;rdquo; In joining the firm, Brendan said: &amp;ldquo;Arnold &amp;amp; Porter has an excellent reputation in the financial services industry for providing strategic advice to banks and other financial institutions on a range of regulatory, compliance, litigation and transactional matters. I&amp;rsquo;m excited to join a platform that combines these capabilities and to leverage the firm&amp;rsquo;s expertise and depth in this sector. As the regulatory landscape continues to evolve, I look forward to advising clients alongside such a talented group of attorneys working in this space.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Brendan earned his J.D. from William &amp;amp; Mary Law School, &lt;em&gt;summa cum laude&lt;/em&gt;, and his B.A. from Colgate University, &lt;em&gt;magna cum laude&lt;/em&gt;. He served as a law clerk for the U.S. District Court in the Eastern District of New York. &lt;/p&gt;

&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9366ECD3-36D6-425D-A1B6-86969C7B83B5}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-advises-oneview-commerce-on-epos-contract-with-uk-post-office</link><title>Arnold &amp; Porter Advises OneView Commerce on EPOS Contract with UK Post Office</title><description>Arnold &amp;amp; Porter advised OneView Commerce on its contract with the United Kingdom Post Office for an electronic point-of-sale (EPOS) system.</description><pubDate>Mon, 24 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter advised &lt;a href="https://corporate.postoffice.co.uk/media-centre/#/pressreleases/all-suppliers-now-in-place-for-horizon-replacement-programme-as-post-office-signs-contracts-with-oneview-commerce-and-escher-3462058"&gt;OneView Commerce&lt;/a&gt; on its contract with the United Kingdom Post Office for an electronic point-of-sale (EPOS) system. The contract comes as part of the Post Office&amp;rsquo;s replacement of its current Horizon system. &lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Corporate &amp;amp; Finance partner Jeremy Willcocks and included associate Matty Desmond. Partner John Schmidt advised on antitrust matters.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{17A19690-6073-4CEC-8B62-ADDA4A0F471F}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/carbon-capture-pooling-statutes-after-north-dakota-rulings-lessons-for-regulators-and-developers</link><a10:author><a10:name>Samuel Pickerill</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pickerill-samuel</a10:uri><a10:email>samuel.pickerill@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sarah Grey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/grey-sarah</a10:uri><a10:email>Sarah.Grey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ethan G. Shenkman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shenkman-ethan-g</a10:uri><a10:email>ethan.shenkman@arnoldporter.com</a10:email></a10:author><title>Carbon Capture Pooling Statutes After North Dakota Rulings: Lessons for Regulators and Developers</title><description>State litigation over carbon capture and storage (CCS) is testing a core element in many existing statutory CCS frameworks: whether a legislature may allow nonconsenting landowners to be forced to provide their pore space for an operator&amp;rsquo;s CCS facility through &amp;ldquo;amalgamation&amp;rdquo; procedures (sometimes referred to as &amp;ldquo;unitization&amp;rdquo; or &amp;ldquo;pooling&amp;rdquo;) similar to mechanisms used for the extraction of oil and gas interests. Two recent North Dakota decisions struck down the application of amalgamation to CCS, holding that forced unitization of pore space is a taking, and that the state&amp;rsquo;s CCS statutes did not provide for &amp;ldquo;just compensation&amp;rdquo; under North Dakota&amp;rsquo;s state constitution. This Advisory summarizes those rulings and the pending appeals, and assesses how similar reasoning may impact existing CCS statutes, using Louisiana and Indiana as illustrative examples, as well as the regulatory process currently underway in California to address unitization.</description><pubDate>Mon, 24 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;State litigation over carbon capture and storage (CCS) is testing a core element in many existing statutory CCS frameworks: whether a legislature may allow nonconsenting landowners to be forced to provide their pore space for an operator&amp;rsquo;s CCS facility through &amp;ldquo;amalgamation&amp;rdquo; procedures (sometimes referred to as &amp;ldquo;unitization&amp;rdquo; or &amp;ldquo;pooling&amp;rdquo;) similar to mechanisms used for the extraction of oil and gas interests. Two recent North Dakota decisions struck down the application of amalgamation to CCS, holding that forced unitization of pore space is a taking, and that the state&amp;rsquo;s CCS statutes did not provide for &amp;ldquo;just compensation&amp;rdquo; under North Dakota&amp;rsquo;s state constitution. This Advisory summarizes those rulings and the pending appeals, and assesses how similar reasoning may impact existing CCS statutes, using Louisiana and Indiana as illustrative examples, as well as the &lt;a rel="noopener noreferrer" href="https://ww2.arb.ca.gov/resources/documents/concepts-potential-regulations" target="_blank"&gt;regulatory process currently underway in California&lt;/a&gt; to address unitization. Drawing on learnings from these North Dakota decisions, the California rulemaking process gives project proponents an opportunity to encourage the adoption of a durable unitization mechanism that can withstand legal challenge and be reliably applied to projects in the state.&lt;/p&gt;
&lt;h2&gt;North Dakota Courts Hold Pore Space Amalgamation Is a Taking&lt;/h2&gt;
&lt;p&gt;In December 2025 and March 2026, two North Dakota district courts struck down the pore space amalgamation provisions of the state&amp;rsquo;s CCS statute, N.D.C.C. &amp;sect; 38-22, which had provided storage operators a mechanism to combine nonconsenting owners&amp;rsquo; pore space interests into a storage facility unit upon a finding that they &amp;ldquo;will be&amp;rdquo; equitably compensated.[[N: N.D.C.C. &amp;sect;&amp;sect; 38-22-08(14), 38-22-10.]] They found this mechanism to be unconstitutional under the takings clause of the state constitution.[[N: &lt;em&gt;Swenson Living Trust v. NDIC&lt;/em&gt;, No. 08-2025-CV-00095 (N.D. Dist. Mar. 9, 2026); &lt;em&gt;Northwest Landowners Ass&amp;rsquo;n v. State&lt;/em&gt;, No. 05-2023-CV-00065 (N.D. Dist. Dec. 2, 2025). The state takings clause is N.D. Const. art. I, &amp;sect; 16.]]&lt;/p&gt;
&lt;p&gt;Both courts followed the same analytical path, drawing on federal Fifth Amendment jurisprudence. First, they held that amalgamation is a taking: landowners hold a property interest in their pore space, and the permanent physical presence of injected carbon dioxide is a per se taking under &lt;em&gt;Loretto v. Teleprompter Manhattan CATV Corp&lt;/em&gt;.[[N: &lt;em&gt;Loretto v. Teleprompter Manhattan CATV Corp.&lt;/em&gt;, 458 U.S. 419 (1982); &lt;em&gt;see Swenson&lt;/em&gt; at &amp;para;&amp;para; 85, 90; &lt;em&gt;NWLA&lt;/em&gt; at &amp;para; 14.]] Under &lt;em&gt;Loretto&lt;/em&gt;, a permanent physical occupation is a taking however important the public interest or slight the intrusion.[[N: &lt;em&gt;Loretto&lt;/em&gt;, 458 U.S. at 434-35, 441.]] In applying Loretto, neither court considered whether carbon dioxide injected deep below the surface interfered with the landowners&amp;rsquo; enjoyment of their land in finding a taking.&lt;/p&gt;
&lt;p&gt;Second, they held that the &amp;ldquo;correlative rights doctrine&amp;rdquo; does not reach carbon storage. That doctrine treats pooling oil and gas interests for extraction as a permissible, non-compensable regulation rather than a taking. The courts distinguished sharing a common, migrating resource (i.e., subsurface oil and gas) from injecting and storing a foreign substance in another landowner&amp;rsquo;s pore space, warning that a contrary rule could justify forced storage of nuclear waste, industrial waste, or flood waters beneath the land of nonconsenting property owners.[[N: &lt;em&gt;NWLA&lt;/em&gt; at &amp;para; 33; &lt;em&gt;see Swenson&lt;/em&gt; at &amp;para; 101; NWLA at &amp;para; 34. The doctrine&amp;rsquo;s application to extraction traces to &lt;em&gt;Ohio Oil Co. v. Indiana&lt;/em&gt;, 177 U.S. 190, 210 (1900).]]&lt;/p&gt;
&lt;p&gt;Third, they held that the statute failed to provide the &amp;ldquo;just compensation&amp;rdquo; the state constitution demands, on two independent grounds. First, Article I, &amp;sect; 16, the state&amp;rsquo;s takings clause, requires just compensation to be paid before possession, whereas the CCS statute permits amalgamation upon a finding that owners &amp;ldquo;will be&amp;rdquo; paid. Second, &amp;sect; 16 requires a jury, not the commission, to determine just compensation.[[N: &lt;em&gt;Swenson&lt;/em&gt; at &amp;para;&amp;para; 104, 114-15; &lt;em&gt;NWLA&lt;/em&gt; at &amp;para;&amp;para; 22, 24-25.]]&lt;/p&gt;
&lt;p&gt;The state has appealed both rulings. In the Swenson appeal, a motion to stay awaits resolution of an attorney&amp;rsquo;s fees issue still before the trial court. Opening briefs filed in the NWLA appeal only whether amalgamation is a taking; none of them defend the statute&amp;rsquo;s compensation scheme.[[N: &lt;em&gt;See Northwest Landowners Ass&amp;rsquo;n v. State&lt;/em&gt;, No. 20260199 (N.D.), Dkt. Nos. 32, 35, 55, 57.]]&lt;/p&gt;
&lt;p&gt;The appellants in NWLA argue amalgamation is not a taking under two theories:&lt;/p&gt;
&lt;p&gt;First, they argue the courts should have applied &lt;em&gt;United States v. Causby&lt;/em&gt; and required landowners to show &amp;ldquo;direct and immediate interference&amp;rdquo; with surface use, rather than &lt;em&gt;Loretto&lt;/em&gt;&amp;rsquo;s &lt;em&gt;per se&lt;/em&gt; rule for physical invasions.[[N: &lt;em&gt;United States v. Causby&lt;/em&gt;, 328 U.S. 256, 266 (1946).]] They point out that not every authorized intrusion is a taking. In &lt;em&gt;Causby&lt;/em&gt;, the Supreme Court recognized practical limits on airspace rights to accommodate the advent of air travel, requiring landowners to show that overhead flights posed a &amp;ldquo;direct and immediate interference&amp;rdquo; with the enjoyment of their land before it would find a taking.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Some courts, like &lt;em&gt;Chance v. BP Chemicals&lt;/em&gt;, similarly treat subsurface property rights as less than absolute, requiring more than mere physical occupation to find a taking.[[N: &lt;em&gt;See Chance v. BP Chems., Inc.&lt;/em&gt;, 670 N.E.2d 985, 993 (Ohio 1996); &lt;em&gt;see Kerns v. Chesapeake Expl., L.L.C.&lt;/em&gt;, 762 F. App&amp;rsquo;x 289, 297 (6th Cir. 2019).]] These courts reason that just as air travel far overhead warranted reasonable limits on air rights, injection wells too deep underground to disturb surface use warrant reasonable limits on subsurface rights. Following this reasoning, the North Dakota appellants urge the court to apply &lt;em&gt;Causby&lt;/em&gt; in place of &lt;em&gt;Loretto&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Second, appellants argue that amalgamation is consistent with the correlative rights doctrine, a &amp;ldquo;longstanding background restriction&amp;rdquo; on property rights.[[N: &lt;em&gt;Cedar Point Nursery v. Hassid&lt;/em&gt;, 594 U.S. 139, 160 (2021).]] The correlative rights doctrine is rooted in the state&amp;rsquo;s police power to prevent waste of shared natural resources.[[N: &lt;em&gt;Ohio Oil Co. v. Indiana&lt;/em&gt;, 177 U.S. 190, 210 (1900).]] Under the doctrine, a legislature may limit property rights in a common pool to prevent waste without effecting a taking.[[N: Id.; &lt;em&gt;see Cities Serv. Gas Co. v. Peerless Oil &amp;amp; Gas Co.&lt;/em&gt;, 340 U.S. 179, 185 (1950). On the rule of capture, &lt;em&gt;see Texaco Inc. v. Indus. Comm&amp;rsquo;n of N.D.&lt;/em&gt;, 448 N.W.2d 621, 623 n.2 (N.D. 1989).]]&lt;/p&gt;
&lt;p&gt;The doctrine plays a prominent role in oil and gas unitization as a limit on the &amp;ldquo;rule of capture.&amp;rdquo;[[N: Id.]] Under the &amp;ldquo;rule of capture,&amp;rdquo; a landowner does not own migratory resources, such as subsurface oil and gas, until the landowner physically takes possession of the resource (e.g. through extraction). However, unrestricted &amp;ldquo;rule of capture&amp;rdquo; incentivizes a wasteful drilling race for each landowner to maximize the amount of oil and gas they can claim ownership over.[[N: Id.]] To address this waste, states enacted pooling and unitization statutes to curtail individual drilling rights for the protection of the common reservoir. Courts have consistently held that the restriction of rights necessary to accomplish that pooling is an exercise of police power &amp;mdash; not a compensable taking.[[N: Id.]]&lt;/p&gt;
&lt;p&gt;Appellants argue an analogous correlative rights doctrine should be applied to the use of pore space as a subsurface resource. The state trial courts in &lt;em&gt;NWLA&lt;/em&gt; and &lt;em&gt;Swenson&lt;/em&gt; each rejected this reasoning by distinguishing between migratory oil and gas resources, to which rule of capture applies, and stationary pore space resources, to which, they concluded, neither rule of capture &amp;mdash; nor correlative rights doctrine as a limit to rule of capture &amp;mdash; could apply.&lt;/p&gt;
&lt;h2&gt;Considerations for California&amp;rsquo;s Rulemaking&lt;/h2&gt;
&lt;p&gt;Although North Dakota caselaw of course is not binding outside of that state, courts in other states may find the reasoning persuasive as some of the first cases to directly address this issue. &lt;a rel="noopener noreferrer" href="https://cdrlaw.org/ccus-tracker/" target="_blank"&gt;This presents significant risk across the country&lt;/a&gt; as 18 other states have enacted CCS amalgamation mechanisms similar in some respects to the now-stricken North Dakota statute. As California regulators grapple with how to design that state&amp;rsquo;s forthcoming framework, they may consider looking to other states&amp;rsquo; approaches to bolstering the legal durability of their rules.&lt;/p&gt;
&lt;p&gt;As one example, Louisiana&amp;rsquo;s CCS unitization statute is currently facing a constitutional due process challenge in &lt;em&gt;Save My Louisiana, Inc. v. State&lt;/em&gt;.[[N: &lt;em&gt;Save My Louisiana, Inc. v. State&lt;/em&gt;, Case No. C-770744, La. 27th Judicial Dist. Ct..]] From 2009 to 2024 Louisiana&amp;rsquo;s CCS statutes effectuated combination of pore space through eminent domain, subject to the state&amp;rsquo;s general eminent domain procedures.[[N: La. R.S. 19:2.]] That scheme entitled a party to jury determination of just compensation, and required either deposit or direct payment of compensation as a condition precedent to the transfer of ownership.[[N: La. Stat. Ann. &amp;sect;&amp;sect; 19:4, 19:10.]] In 2024 the state shifted away from these eminent domain procedures to a new unitization framework that more closely mirrors the state&amp;rsquo;s oil and gas unitization process.[[N: La. R.S. 30:1104.2.]] However, the statute would explicitly revert back to the prior eminent domain framework if a court finds the unitization statute unconstitutional.[[N: La. R.S. 30:1104.2(K).]] Although the current challenge takes aim at both the eminent domain and unitization frameworks, this built-in contingency plan provides a potential avenue for the state to prevail on the more established eminent domain procedures even if the Louisiana court adopts &lt;em&gt;NWLA&lt;/em&gt; and &lt;em&gt;Swensen&lt;/em&gt;&amp;rsquo;s reasoning with respect to unitization.&lt;/p&gt;
&lt;p&gt;Another example, Indiana, utilizes a belt-and-suspenders approach to address takings risks. There, the regulatory regime predicates an amalgamation order upon a finding that the order is consistent with state authority to prevent waste, protect correlative rights, and promote efficient use of natural resources, and constitutes a public use serving the public interest.[[N:&amp;nbsp;312 IAC &amp;sect; 30-55-3.]] But the regulations also set forth a detailed structure for determining the equitable compensation to be provided to the landowner based on the &amp;ldquo;weighted average of consideration paid to consenting pore space owners in the same project,&amp;rdquo;[[N:&amp;nbsp;312 IAC 30-5.5-4.]] while allowing nonconsenting pore space owners to submit evidence of fair market value of pore space, including an appraisal, and to contest equitable compensation amounts both at a hearing before the agency and through judicial review under the state&amp;rsquo;s administrative appeals procedure.[[N:&amp;nbsp;312 IAC &amp;sect; 30-55-2; Id. &amp;sect; 30-55-4; IC &amp;sect; 4-21.5.]] Thus, even if a court finds that the correlative rights doctrine does not apply and amalgamation is a taking, the enumerated procedural protections for landowners help reinforce the defense that the compensation provided is consistent with the state&amp;rsquo;s constitutional requirements.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Turning to California, the state&amp;rsquo;s skeleton CCS amalgamation statute sets forth certain minimum requirements, but leaves considerable leeway for the California Air Resources Board (CARB) to build out the details of the program.[[N: Cal. Health &amp;amp; Safety Code &amp;sect;&amp;sect; 39741.1, 39741.2.]] That rulemaking is now underway with the issuance of &lt;a rel="noopener noreferrer" href="https://ww2.arb.ca.gov/resources/documents/concepts-potential-regulations" target="_blank"&gt;Concepts for Potential Regulations&lt;/a&gt; in May 2026. The rulemaking provides an opportunity for CARB to ensure consistency with California&amp;rsquo;s constitutional takings clause which is among the most protective and similar to North Dakota&amp;rsquo;s. Like North Dakota, California explicitly requires both payment before possession and a jury determination of just compensation as of right.[[N: Cal. Const. art. I, &amp;sect; 19.]]&lt;/p&gt;
&lt;p&gt;Challengers may therefore argue that a North Dakota-style framework, which neither pays before possession nor guarantees a jury, is inconsistent with California&amp;rsquo;s specific constitutional requirements. California does, however, carve out quick-take statutes in its takings clause. The state&amp;rsquo;s constitution permits the government to take possession upon a deposit &amp;mdash; set initially by a qualified expert, not a jury &amp;mdash; that is promptly released to the owner, with final compensation determined later.[[N: &lt;em&gt;Med. Acquisition Co. v. Superior Court&lt;/em&gt;, 228 Cal. Rptr. 3d 654, 659 (Cal. Ct. App. 2018).]] California has an opportunity to build its CCS program on that quick-take footing and to borrow from Louisiana&amp;rsquo;s and Indiana&amp;rsquo;s belt-and-suspenders structure. Like Indiana, regulations can ground administrative authority in the protection of correlative rights to protect against a threshold takings determination, while also affording procedural protections to landowners to support that the compensation provided is just, even if a taking occurs. Like Louisiana, CARB can also incorporate fallback provisions to explicitly invoke more established compensation procedures, such as a jury-determined process, if the amalgamation mechanism is held unconstitutional. For example, drawing from quick-take statutes, the agency could value the pore space, deposit that amount, and take possession &amp;mdash; constitutionally deferring the jury&amp;rsquo;s just-compensation determination while keeping projects on track, and insulating the program from constitutional challenges.&amp;nbsp;&lt;/p&gt;
&lt;p style="text-align: center;"&gt;* * *&lt;/p&gt;
&lt;p&gt;The recent court decisions in &lt;em&gt;NWLA&lt;/em&gt; and &lt;em&gt;Swenson&lt;/em&gt; are among the first judicial decisions to directly address the constitutionality of state CCS unitization frameworks, which have proliferated to at least 18 states. Though the decisions are only binding within North Dakota and are subject to ongoing appeals, project proponents and regulators should take notice of these courts&amp;rsquo; reasoning when designing and implementing future regulatory frameworks to be durable and insulated from legal challenge.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;More detailed information on CCS state legislation is available on &lt;a rel="noopener noreferrer" href="https://cdrlaw.org/ccus-tracker/" target="_blank"&gt;Arnold &amp;amp; Porter&amp;rsquo;s state-by-state CCS Tracker&lt;/a&gt;, a collaboration with Columbia Law School&amp;rsquo;s Sabin Center for Climate Change Law. The CCS Tracker has also recently been integrated into the &lt;a rel="noopener noreferrer" href="http://www.carbonstorage.io/ccspolicy" target="_blank"&gt;carbonstorage.io&lt;/a&gt; platform to provide a deeper and more comprehensive database for parties engaged in the CCS industry, including site mapping, permitting information, and economic analyses.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;* Peter Lengwin contributed to this Advisory. Peter is a summer associate in Arnold &amp;amp; Porter&amp;rsquo;s Washington, D.C. office.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{719520BD-B5E8-4293-B6E8-052381C6C584}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/bis-issues-final-rule-easing-drone-export-controls-alongside-presidents-new-tariffs-on-drone-imports</link><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Deborah A. Curtis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/curtis-deborah</a10:uri><a10:email>deborah.curtis@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lynn Fischer Fox</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fischer-fox-lynn</a10:uri><a10:email>lynn.fischerfox@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nicholas L. Townsend</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/townsend-nicholas-l</a10:uri><a10:email>nicholas.townsend@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Trevor G. Schmitt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmitt-trevor-g</a10:uri><a10:email>trevor.schmitt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bell Johnson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/johnson-bell</a10:uri><a10:email>bell.johnson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sarah Belmont</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/belmont-sarah</a10:uri><a10:email>sarah.belmont@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dustin Vesey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vesey-dustin</a10:uri><a10:email>dustin.vesey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kristina Lorch</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lorch-kristina</a10:uri><a10:email>kristina.lorch@arnoldporter.com</a10:email></a10:author><title>BIS Issues Final Rule Easing Drone Export Controls, Alongside President’s New Tariffs on Drone Imports</title><description>On August 13, 2026, the U.S. government took two actions aimed at strengthening the competitiveness of its domestic drone industry.&amp;nbsp;First, the U.S. Department of Commerce&amp;rsquo;s Bureau of Industry and Security (BIS) issued a final rule, effective immediately, that eases export control restrictions on many commercial unmanned aerial vehicles (UAVs or drones), related parts and components, and associated software and technology. Second, President Donald Trump issued a presidential proclamation implementing Section 232 tariffs on certain drones and critical components. Taken together, these measures are designed to support the growth of the domestic drone sector by easing exports of lower-risk commercial UAVs, promoting U.S.-based manufacturing and sourcing by restricting imports, and maintaining controls on advanced technologies that raise national security concerns if transferred to certain foreign actors.</description><pubDate>Mon, 24 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On August 13, 2026, the U.S. government took two actions aimed at strengthening the competitiveness of its domestic drone industry. First, the U.S. Department of Commerce&amp;rsquo;s Bureau of Industry and Security (BIS) issued a &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/08/14/2026-16628/streamlining-export-controls-for-drone-exports" target="_blank"&gt;final rule&lt;/a&gt;, effective immediately, that eases export control restrictions on many commercial unmanned aerial vehicles (UAVs or drones), related parts and components, and associated software and technology. Second, President Donald Trump issued a presidential proclamation implementing Section 232 tariffs on certain drones and critical components. Taken together, these measures are designed to support the growth of the domestic drone sector by easing exports of lower-risk commercial UAVs, promoting U.S.-based manufacturing and sourcing by restricting imports, and maintaining controls on advanced technologies that raise national security concerns if transferred to certain foreign actors.&lt;/p&gt;
&lt;/p&gt;
&lt;h2&gt;BIS&amp;rsquo;s Reduced Export Controls on UAVs&lt;/h2&gt;
&lt;p&gt;BIS&amp;rsquo;s final rule implements part of &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2025/06/11/2025-10814/unleashing-american-drone-dominance" target="_blank"&gt;Executive Order 14307&lt;/a&gt;, &amp;ldquo;Unleashing American Drone Dominance,&amp;rdquo; issued on June 6, 2025, which directed the Departments of Commerce, Energy, State, and Defense to review and revise restrictions under the Export Administration Regulations (EAR) to facilitate the export of UAVs to foreign partners. The most significant changes brought about by BIS&amp;rsquo;s new rule are that BIS removed National Security Column 2 (NS2) controls from Export Control Classification Number (ECCN) 9A012.a, eliminated wind gust tolerance as a control parameter, and increased the endurance threshold for national security controls from 30 minutes to three hours. As a result, drones with a maximum endurance of less than three hours generally will be controlled only for anti-terrorism (AT) reasons. UAVs with an endurance of three hours or more will continue to be controlled for National Security Column 1 (NS1) and AT reasons. &lt;/p&gt;
&lt;p&gt;The rule does not relax controls on certain higher-risk UAV capabilities. Drones with a range of at least 300 kilometers (approximately 186 miles), or that otherwise meet the parameters of ECCN 9A120, remain subject to Missile Technology (MT) controls. BIS also retained heightened controls for certain UAVs, regardless of endurance, that incorporate specified lasers, thermal imaging equipment, or navigation systems. According to BIS, these controls are intended to prevent adversaries from acquiring sensitive optical or navigational equipment by buying inexpensive, low-endurance drones fitted with high-performance, easily detachable payloads or equipment.&lt;/p&gt;
&lt;p&gt;BIS also made conforming changes to UAV-related software and technology controls. As a result, many commercial drones, as well as related software and technology, may now be exported, reexported, or transferred (in-country) to most destinations on a No License Required (NLR) basis. However, BIS preserved military end-use or military end-user restrictions by adding ECCNs 9A012, 9D001, 9D002, 9D004, and 9E001 to Supplement No. 2 to Part 744 of the EAR.&lt;/p&gt;
&lt;p&gt;The rule also clarifies the treatment of UAVs designed for military applications. BIS explained that certain drones not covered by the International Traffic in Arms Regulations&amp;rsquo; (ITAR) U.S. Munitions List (USML) may nevertheless be classified under ECCN 9A610 if they are designed or modified with military-specific capabilities that would not ordinarily be included in a commercial product. BIS further expanded the availability of License Exception Strategic Trade Authorization (STA) for certain UAVs classified under ECCN 9A610 and destined for Country Group A:5 countries. This expanded eligibility is available only where the UAV does not exceed specified capability thresholds, including the ability to deliver a payload of 500 kg (approximately 1,102 pounds) to a range of at least 300 km.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Overall, the rule represents a meaningful relaxation of restrictions for many commercial UAVs and related software or technology. BIS&amp;rsquo;s stated objective is to better align the EAR with the current drone landscape by removing restrictions on widely available commercial capabilities while focusing controls on UAVs that present more significant national security concerns.&lt;/p&gt;
&lt;h2&gt;President Trump&amp;rsquo;s New Tariffs on UAV Imports&lt;/h2&gt;
&lt;p&gt;On the same day BIS issued its final rule, President Trump issued a &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/08/19/2026-16979/adjusting-imports-of-unmanned-aircraft-systems-and-unmanned-aircraft-systems-components-into-the" target="_blank"&gt;proclamation&lt;/a&gt; under Section 232 of the Trade Expansion Act of 1962, imposing tariffs on UAVs and related components. The proclamation follows an investigation by the Commerce Department that determined imports of such items may threaten U.S. national security due to foreign supply-chain dependence, cybersecurity concerns, and inadequate domestic production capacity to meet anticipated military and commercial demand. &lt;/p&gt;
&lt;p&gt;Effective September 3, 2026, imports of (1) drones with a maximum take-off weight of more than 25 kilograms (approximately 55 pounds), (2) drones that integrate thermal imagers, (3) drone docking stations, and (4) certain drone components will be subject to a 100% tariff. The products covered by this tariff are identified by the respective Harmonized Tariff Schedule (HTS) Codes in &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/wp-content/uploads/2026/08/ANNEX-I-1.pdf" target="_blank"&gt;Annex I&lt;/a&gt;. Other drones with a maximum take-off weight of 25 kilograms or less will be subject to a 25% tariff, with the covered products identified by HTS Code in &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/wp-content/uploads/2026/08/Annex-II-1.pdf" target="_blank"&gt;Annex II&lt;/a&gt;. Meanwhile, starting on February 9, 2027, certain drone components identified by their HTS Codes in &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/wp-content/uploads/2026/08/Annex-III.pdf" target="_blank"&gt;Annex III&lt;/a&gt; will be subject to a 25% tariff. The proclamation delays implementation for companies included in the Department of Defense&amp;rsquo;s Blue UAS Cleared List, the Blue UAS Framework, or the Federal Communications Commission&amp;rsquo;s Conditional Approval List as of September 2, 2026 until February 9, 2027. The delayed implementation covers Covered Products that are included on the FCC&amp;rsquo;s Conditional Approval List and their components, as well as products included on the Department of Defense&amp;rsquo;s Blue UAS Cleared List and their components.&lt;/p&gt;
&lt;p&gt;Lower tariff rates will be applied to products of European Union member states, Japan, South Korea, Taiwan, Switzerland, Liechtenstein, and the United Kingdom. Qualifying U.K. products will be subject to a total duty rate not to exceed 10%, while qualifying products from the other jurisdictions will face a maximum duty rate of 15%. These reduced rates are only available &amp;ldquo;if substantially all the critical components and technology are certified by importers to be products&amp;rdquo; of those countries or of the United States.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Companies should be aware that the tariff regime remains subject to change, as the proclamation grants the Secretary of Commerce broad authority to expand tariff coverage to additional UAV components and to revise prior coverage determinations as national security considerations evolve.&lt;/p&gt;
&lt;p&gt;The proclamation also directs the Secretary of Commerce to establish an onshoring incentive program. Under the program, companies that commit to building, expanding, or refurbishing U.S. facilities for the production of UAVs and related components, may qualify for temporary relief from Section 232 duties on certain imported products and production equipment while those facilities are under development. To qualify for tariff relief, construction must begin before the end of the Trump administration on January 20, 2029.&lt;/p&gt;
&lt;p&gt;The Secretary of Commerce is authorized to approve onshoring plans and may consider the following factors: (1) whether the plan has received conditional approval from the Departments of Defense and Homeland Security, (2) the anticipated start date, (3) the reasonableness of the project&amp;rsquo;s timeline and milestones, (4) projected annual production capacity, and (5) the manner in which any tariff-related benefits will be allocated among participants.&amp;nbsp;&lt;/p&gt;
&lt;h2&gt;Takeaways&lt;/h2&gt;
&lt;p&gt;These regulatory developments reflect the Trump administration&amp;rsquo;s ongoing efforts to advance national security and industrial policy objectives in the UAV market. Together, the BIS rule and the new Section 232 tariffs are intended to strengthen the competitiveness of the domestic drone industry by facilitating broader access in foreign markets while incentivizing domestic production and supply chain localization by imposing tariffs on imports. Companies operating in the UAV sector should carefully evaluate both the opportunities created by the revised export controls and the potential costs and sourcing implications associated with the new tariffs. Businesses should also monitor any future development closely as the U.S. government may continue to refine the regulatory framework in the drone sector.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter will continue to monitor developments in this area. For questions about BIS&amp;rsquo;s final rule, the new tariffs, or other national security and trade issues, please contact the authors or any of their colleagues in Arnold &amp;amp; Porter&amp;rsquo;s &lt;a href="/en/services/capabilities/industries/national-security-and-defense"&gt;National Security &amp;amp; Defense&lt;/a&gt;&amp;nbsp;or &lt;a href="/en/services/capabilities/practices/international-trade" target="_self"&gt;International Trade&lt;/a&gt; practice groups.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7D647554-5A4A-4F8E-84F1-3B66A20288A2}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/news</link><title> Chambers Latin America  2027 Recognizes Arnold &amp; Porter Practices, Lawyers</title><description>&lt;p&gt;&lt;em&gt;Chambers Latin America&lt;/em&gt; 2027 highlighted Arnold &amp;amp; Porter as a &amp;ldquo;Leading Firm&amp;rdquo; in three practice areas and recognized six lawyers as &amp;ldquo;Leading Individuals.&amp;rdquo; The annual guide ranks law firms and individuals based on independent research conducted by Chambers researchers. &lt;em&gt;Chambers Latin America &lt;/em&gt;covers 19 jurisdictions that span Mexico, Central America, and the Caribbean, as well as Spanish-speaking countries in South America.&lt;/p&gt;</description><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;em&gt;Chambers Latin America&lt;/em&gt; 2027 highlighted Arnold &amp;amp; Porter as a &amp;ldquo;Leading Firm&amp;rdquo; in three practice areas and recognized six lawyers as &amp;ldquo;Leading Individuals.&amp;rdquo; The annual guide ranks law firms and individuals based on independent research conducted by Chambers researchers. &lt;em&gt;Chambers Latin America &lt;/em&gt;covers 19 jurisdictions that span Mexico, Central America, and the Caribbean, as well as Spanish-speaking countries in South America.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Chambers Latin America&lt;/em&gt; ranked Arnold &amp;amp; Porter as leading &amp;ldquo;International Counsel&amp;rdquo; in the following practice areas: Capital Markets, Corporate Crime &amp;amp; Investigations, and International Arbitration. The Capital Markets team was recognized for its &amp;ldquo;proven track record of representing sovereigns and state-owned entities in high-value debt offerings in Latin America.&amp;rdquo; Clients praised the Corporate Crime &amp;amp; Investigations team for its &amp;ldquo;extensive experience and in-depth knowledge of corporate crime matters,&amp;rdquo; describing the team as &amp;ldquo;reliable, efficient and accurate.&amp;rdquo; The guide also highlighted the International Arbitration group, noting its &amp;ldquo;wealth of experience handling some of the most complex investor-state disputes in the arbitration field&amp;rdquo; and &amp;ldquo;unique sophistication built on well-defined, organized processes.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In addition to the three practice area rankings, the following lawyers were recognized by&lt;em&gt; Chambers Latin America &lt;/em&gt;2027:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Marcus Asner&amp;mdash;Corporate Crime &amp;amp; Investigations&lt;/li&gt;
    &lt;li&gt;Whitney Debevoise&amp;mdash;Capital Markets&lt;/li&gt;
    &lt;li&gt;Paolo Di Rosa&amp;mdash;International Arbitration&lt;/li&gt;
    &lt;li&gt;Patricio Gran&amp;eacute; Labat&amp;mdash;International Arbitration&lt;/li&gt;
    &lt;li&gt;Gregory Harrington&amp;mdash;Banking &amp;amp; Finance; Capital Markets&lt;/li&gt;
    &lt;li&gt;M&amp;eacute;lida Hodgson&amp;mdash;International Arbitration&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{95FCEB15-0E11-448A-8916-5C8CD75BB7CD}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/best-lawyers-in-america-2027-recognizes-144-arnold-porter-lawyers</link><title> Best Lawyers in America  2027 Recognizes 144 Arnold &amp; Porter Lawyers</title><description>The 2027 edition of&lt;em&gt; Best Lawyers in America&lt;/em&gt; recognized 95 Arnold &amp;amp; Porter lawyers as &amp;ldquo;Best Lawyers&amp;rdquo; across 56 practice areas. Best Lawyers is a peer-reviewed survey where lawyers cast votes on the legal capabilities of other lawyers in their practice areas.</description><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 2027 edition of &lt;em&gt;Best Lawyers in America&lt;/em&gt; recognized 95 Arnold &amp;amp; Porter lawyers as &amp;ldquo;Best Lawyers&amp;rdquo; across 56 practice areas. Best Lawyers is a peer-reviewed survey where lawyers cast votes on the legal capabilities of other lawyers in their practice areas.&lt;/p&gt;
&lt;p&gt;The guide also included the &amp;ldquo;Ones to Watch&amp;rdquo; list, which recognizes lawyers who are less than ten years into their careers. This year&amp;rsquo;s &amp;ldquo;Ones to Watch&amp;rdquo; recognized 49 Arnold &amp;amp; Porter lawyers for their &amp;ldquo;outstanding professional excellence in private practice.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Best Lawyers&lt;/em&gt; also named six Arnold &amp;amp; Porter lawyers as &amp;ldquo;Lawyers of the Year,&amp;rdquo; an annual recognition presented to one &amp;ldquo;outstanding lawyer&amp;rdquo; per practice and metropolitan area.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter &amp;ldquo;Lawyers of the Year&amp;rdquo; are:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Brian P. Dunphy&amp;mdash;Litigation &amp;ndash; Health Care in Boston, Massachusetts&lt;/li&gt;
    &lt;li&gt;Rosa J. Evergreen&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law in Washington, D.C.&lt;/li&gt;
    &lt;li&gt;Debbie Feinstein&amp;mdash;Antitrust Law in Washington, D.C.; Litigation &amp;ndash; Antitrust in Washington, D.C.&lt;/li&gt;
    &lt;li&gt;Michael D. Goodwin&amp;mdash;Leisure and Hospitality Law in Washington, D.C.; Real Estate Law in Washington, D.C.&lt;/li&gt;
    &lt;li&gt;Ronald R. Levine II&amp;mdash;Mergers and Acquisitions Law in Denver, Colorado&lt;/li&gt;
    &lt;li&gt;Jeffrey D. Talbert&amp;mdash;Litigation &amp;ndash; Environmental in Newark, New Jersey&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The Arnold &amp;amp; Porter &amp;ldquo;Best Lawyers&amp;rdquo; are:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Laurie Abramowitz&amp;mdash;Tax Law&lt;/li&gt;
    &lt;li&gt;Anand Agneshwar&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Richard M. Alexander&amp;mdash;Banking and Finance Law; Financial Services Regulation Law&lt;/li&gt;
    &lt;li&gt;Rosemary Alito&amp;mdash;Employment Law &amp;ndash; Management; Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Henry D. Almond&amp;mdash;International Trade and Finance Law&lt;/li&gt;
    &lt;li&gt;Christopher Anderson&amp;mdash;Health Care Law&lt;/li&gt;
    &lt;li&gt;John P. Barker&amp;mdash;International Trade and Finance Law&lt;/li&gt;
    &lt;li&gt;Annette E. Becker&amp;mdash;Corporate Law; Mergers and Acquisitions Law&lt;/li&gt;
    &lt;li&gt;John B. Bellinger III&amp;mdash;International Trade and Finance Law&lt;/li&gt;
    &lt;li&gt;David Benyacar&amp;mdash;Litigation &amp;ndash; Intellectual Property&lt;/li&gt;
    &lt;li&gt;Marisa Bocci&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Arthur E. Brown&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Sean M. Callagy&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Gina M. Cavalier&amp;mdash;Health Care Law&lt;/li&gt;
    &lt;li&gt;Maria Chedid&amp;mdash;International Arbitration &amp;ndash; Commercial&lt;/li&gt;
    &lt;li&gt;Kenneth L. Chernof&amp;mdash;Privacy and Data Security Law&lt;/li&gt;
    &lt;li&gt;Sarah Constantine&amp;mdash;Trusts and Estates&lt;/li&gt;
    &lt;li&gt;James W. Cooper&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Frank Cruz-Alvarez&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Mahnu Davar&amp;mdash;FDA Law&lt;/li&gt;
    &lt;li&gt;Edward A. Deibert&amp;mdash;Mergers and Acquisitions Law&lt;/li&gt;
    &lt;li&gt;Paolo Di Rosa&amp;mdash;International Arbitration &amp;ndash; Commercial; International Arbitration &amp;ndash; Governmental&lt;/li&gt;
    &lt;li&gt;Daniel P. DiNapoli&amp;mdash;Biotechnology and Life Sciences Practice&lt;/li&gt;
    &lt;li&gt;Brian P. Dunphy&amp;mdash;Health Care Law; Litigation &amp;ndash; Health Care&lt;/li&gt;
    &lt;li&gt;John P. Elwood&amp;mdash;Appellate Practice&lt;/li&gt;
    &lt;li&gt;Rosa J. Evergreen&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Litigation &amp;ndash; Bankruptcy&lt;/li&gt;
    &lt;li&gt;Debbie Feinstein&amp;mdash;Antitrust Law; Litigation &amp;ndash; Antitrust&lt;/li&gt;
    &lt;li&gt;John M. Fietkiewicz&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Mark S. Filipini&amp;mdash;Employment Law - Management; Labor Law &amp;ndash; Management; Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Paul J. Fishman&amp;mdash;Appellate Practice; Criminal Defense: White-Collar; Qui Tam Law&lt;/li&gt;
    &lt;li&gt;Lynn Fischer Fox&amp;mdash;International Trade and Finance Law&lt;/li&gt;
    &lt;li&gt;John D. Geelan&amp;mdash;Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Daniel M. Glassman&amp;mdash;Commercial Litigation; Health Care Law&lt;/li&gt;
    &lt;li&gt;Jonathan Gleklen&amp;mdash;Antitrust Law; Litigation &amp;ndash; Antitrust&lt;/li&gt;
    &lt;li&gt;Stephen Gliatta&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Michael D. Goodwin&amp;mdash;Leisure and Hospitality Law; Real Estate Law&lt;/li&gt;
    &lt;li&gt;Joel I. Greenberg&amp;mdash;Corporate Law; Leveraged Buyouts and Private Equity Law; Mergers and Acquisitions Law; Securities / Capital Markets Law&lt;/li&gt;
    &lt;li&gt;Louis J. Hait&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Stacey Halliday&amp;mdash;Environmental Law&lt;/li&gt;
    &lt;li&gt;Jeffrey L. Handwerker&amp;mdash;FDA Law&lt;/li&gt;
    &lt;li&gt;Dori Hanswirth&amp;mdash;Copyright Law; Trademark Law&lt;/li&gt;
    &lt;li&gt;Valarie Hays&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Rhys W. Hefta&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;James D. Herschlein&amp;mdash;Mass Tort Litigation / Class Actions &amp;ndash; Defendants; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;M&amp;eacute;lida Hodgson&amp;mdash;Arbitration; International Arbitration &amp;ndash; Commercial&lt;/li&gt;
    &lt;li&gt;Jonathan W. Hughes&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Brian Jackson&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Maureen R. Jeffreys&amp;mdash;Media Law&lt;/li&gt;
    &lt;li&gt;Giselle J. Joffre&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Ronald L. Johnston&amp;mdash;Information Technology Law; Litigation &amp;ndash; Patent&lt;/li&gt;
    &lt;li&gt;James P. Joseph&amp;mdash;Nonprofit / Charities Law; Tax Law&lt;/li&gt;
    &lt;li&gt;Jeffrey H. Kapner&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Fred Kelly&amp;mdash;Mass Tort Litigation / Class Actions &amp;ndash; Defendants; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Daniel A. Kracov&amp;mdash;FDA Law; Health Care Law&lt;/li&gt;
    &lt;li&gt;C. Thomas Kruse&amp;mdash;Commercial Litigation; Litigation &amp;ndash; Insurance&lt;/li&gt;
    &lt;li&gt;Kari L. Larson&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Kevin J. Lavin&amp;mdash;Corporate Law; Mergers and Acquisitions Law&lt;/li&gt;
    &lt;li&gt;Lori B. Leskin&amp;mdash;Mass Tort Litigation / Class Actions &amp;ndash; Defendants; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Ronald R. Levine II&amp;mdash;Corporate Governance Law; Corporate Law; Leveraged Buyouts and Private Equity Law; Mergers and Acquisitions Law; Securities / Capital Markets Law; Venture Capital Law&lt;/li&gt;
    &lt;li&gt;Patrick M. Madden&amp;mdash;Employment Law &amp;ndash; Management; Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Craig D. Margolis&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Karl L. Marschel&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;David R. Marsh&amp;mdash;Biotechnology and Life Sciences Practice&lt;/li&gt;
    &lt;li&gt;Jonathan S. Martel&amp;mdash;Environmental Law&lt;/li&gt;
    &lt;li&gt;Michael McGill&amp;mdash;Government Contracts&lt;/li&gt;
    &lt;li&gt;Michael D. Messersmith&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law&lt;/li&gt;
    &lt;li&gt;Jeffrey A. Miller&amp;mdash;Litigation &amp;ndash; Intellectual Property&lt;/li&gt;
    &lt;li&gt;Randall H. Miller&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Saul P. Morgenstern&amp;mdash;Antitrust Law; Litigation &amp;ndash; Antitrust&lt;/li&gt;
    &lt;li&gt;John N. Nassikas&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Brandon W. Neuschafer&amp;mdash;Environmental Law&lt;/li&gt;
    &lt;li&gt;Evelina J. Norwinski&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Todd L. Nunn&amp;mdash;Litigation &amp;ndash; Labor and Employment; Mass Tort Litigation / Class Actions &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Stephanie Wright Pickett&amp;mdash;Employment Law &amp;ndash; Management; Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Benjamin S. Piper&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Raqiyyah Pippins&amp;mdash;FDA Law&lt;/li&gt;
    &lt;li&gt;Eric S. Prezant&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law&lt;/li&gt;
    &lt;li&gt;Christopher J. Renk&amp;mdash;Litigation &amp;ndash; Intellectual Property; Litigation &amp;ndash; Patent&lt;/li&gt;
    &lt;li&gt;Thomas W. Richardson&amp;mdash;Trusts and Estates&lt;/li&gt;
    &lt;li&gt;Amy B. Rifkind&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Margaret A. Rogers&amp;mdash;Antitrust Law&lt;/li&gt;
    &lt;li&gt;Michael A. Rogoff&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Evan M. Rothstein&amp;mdash;Litigation &amp;ndash; Intellectual Property&lt;/li&gt;
    &lt;li&gt;Scott B. Schreiber&amp;mdash;Litigation &amp;ndash; Securities&lt;/li&gt;
    &lt;li&gt;Sean M. SeLegue&amp;mdash;Appellate Practice; Ethics and Professional Responsibility Law&lt;/li&gt;
    &lt;li&gt;Ethan Shenkman&amp;mdash;Environmental Law&lt;/li&gt;
    &lt;li&gt;Laura Shores&amp;mdash;Antitrust Law&lt;/li&gt;
    &lt;li&gt;Allison W. Shuren&amp;mdash;FDA Law; Health Care Law&lt;/li&gt;
    &lt;li&gt;Howard Sklamberg&amp;mdash;FDA Law&lt;/li&gt;
    &lt;li&gt;Paul W. Sweeney, Jr.&amp;mdash;Commercial Litigation; Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Jeffrey D. Talbert&amp;mdash;Environmental Law; Litigation &amp;ndash; Environmental&lt;/li&gt;
    &lt;li&gt;Eva A. Temkin&amp;mdash;FDA Law&lt;/li&gt;
    &lt;li&gt;Pallavi Mehta Wahi&amp;mdash;Commercial Litigation; Litigation &amp;ndash; Intellectual Property&lt;/li&gt;
    &lt;li&gt;Douglas A. Winthrop&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Pamela J. Yates&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The Arnold &amp;amp; Porter &amp;ldquo;Ones to Watch&amp;rdquo; are:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Devin M. Adams&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Mohamed Al-Hendy&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Eric J. An&amp;mdash;Corporate Law; Mergers and Acquisitions Law&lt;/li&gt;
    &lt;li&gt;James Babounakis&amp;mdash;Commercial Litigation; Litigation &amp;ndash; Antitrust&lt;/li&gt;
    &lt;li&gt;Thomas A. Bird&amp;mdash;Intellectual Property Law; Litigation &amp;ndash; Intellectual Property; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Albert J. Boardman&amp;mdash;Intellectual Property Law&lt;/li&gt;
    &lt;li&gt;Devon K. Blevins&amp;mdash;Litigation &amp;ndash; Labor and Employment&lt;/li&gt;
    &lt;li&gt;Adrienne D. Boyd&amp;mdash;Commercial Litigation; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Sam Callahan&amp;mdash;Appellate Practice; Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Ai-Li Chiong-Martinson&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Alexander Cousins&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Benjamin G. Danieli&amp;mdash;Intellectual Property Law&lt;/li&gt;
    &lt;li&gt;David Denuyl&amp;mdash;Patent Law&lt;/li&gt;
    &lt;li&gt;Matthew R. Diton&amp;mdash;Labor and Employment Law &amp;ndash; Management&lt;/li&gt;
    &lt;li&gt;Therese M. Fox&amp;mdash;Corporate Law&lt;/li&gt;
    &lt;li&gt;Alexander Fung&amp;mdash;Corporate Law&lt;/li&gt;
    &lt;li&gt;Ashley E. Gammell&amp;mdash;Antitrust Law; Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Bridgette C. Gershoni&amp;mdash;Intellectual Property Law; Litigation &amp;ndash; Intellectual Property&lt;/li&gt;
    &lt;li&gt;Brendan M. Gibbons&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Jessica D. Gilbert&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Katelyn A. Horne&amp;mdash;Commercial Litigation; Litigation &amp;ndash; Construction&lt;/li&gt;
    &lt;li&gt;Tommy Huynh&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Kristen Proe Kendall&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Jaclyn Machometa&amp;mdash;Administrative / Regulatory Law; Corporate Law; Health Care Law&lt;/li&gt;
    &lt;li&gt;Mateo Morris Lievano&amp;mdash;Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Corporate Law&lt;/li&gt;
    &lt;li&gt;Daniel J. O&amp;rsquo;Brien&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Jennifer J. Oh&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Mark A. Patrick&amp;mdash;Intellectual Property Law&lt;/li&gt;
    &lt;li&gt;Thomas A. Pettit&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Eliseo R. Puig&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Gerard Quinn&amp;mdash;Litigation &amp;ndash; Antitrust&lt;/li&gt;
    &lt;li&gt;Amanda Raines&amp;mdash;Criminal Defense: White-Collar&lt;/li&gt;
    &lt;li&gt;Katie Roux&amp;mdash;Energy Law; Natural Resources Law; Oil and Gas Law&lt;/li&gt;
    &lt;li&gt;Becca Rozen&amp;mdash;Banking and Finance Law&lt;/li&gt;
    &lt;li&gt;Christian Scarlett&amp;mdash;Real Estate Law&lt;/li&gt;
    &lt;li&gt;Michael J. Sebba&amp;mdash;Intellectual Property Law&lt;/li&gt;
    &lt;li&gt;Amanda J. Sherwood&amp;mdash;Government Relations Practice&lt;/li&gt;
    &lt;li&gt;Samantha Shulman&amp;mdash;Antitrust Law&lt;/li&gt;
    &lt;li&gt;Preston Smith&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Lindsay Strong&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Zachary Aaron Sweebe&amp;mdash;Product Liability Litigation &amp;ndash; Defendants&lt;/li&gt;
    &lt;li&gt;Roee Talmor&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Declan Tansey&amp;mdash;Nonprofit / Charities Law; Tax Law&lt;/li&gt;
    &lt;li&gt;Kelly Trout&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Brian Williams&amp;mdash;Appellate Practice&lt;/li&gt;
    &lt;li&gt;Loreli Wright&amp;mdash;Health Care Law&lt;/li&gt;
    &lt;li&gt;Lauren S. Wulfe&amp;mdash;Commercial Litigation&lt;/li&gt;
    &lt;li&gt;Dylan S. Young&amp;mdash;Antitrust Law&lt;/li&gt;
    &lt;li&gt;William Young, Jr.&amp;mdash;Intellectual Property Law&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{A0C26191-0F32-4DB5-9899-64A979BF12A6}</guid><link>https://www.csha.info/?pg=events&amp;evAction=showDetail&amp;eid=351132&amp;evSubAction=listAll</link><a10:author><a10:name>Michael C. Wood</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wood-michael-c</a10:uri><a10:email>michael.wood@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Loreli (Lori) Wright</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wright-loreli-lori</a10:uri><a10:email>loreli.wright@arnoldporter.com</a10:email></a10:author><title>Federal Pullback, State AG Surge: What California Healthcare Providers Need to Know</title><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{9E2A3630-0B5B-432D-B788-80F16C758526}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/us-expands-cuba-sanctions-part-2-new-designations-and-wind-down-window-closing-fast-for</link><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Trevor G. Schmitt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmitt-trevor-g</a10:uri><a10:email>trevor.schmitt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Isabella F. Uría</a10:name><a10:uri>https://www.arnoldporter.com/en/people/u/uria-isabella</a10:uri><a10:email>isabella.uria@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bell Johnson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/johnson-bell</a10:uri><a10:email>bell.johnson@arnoldporter.com</a10:email></a10:author><title>U.S. Expands Cuba Sanctions, Part 2: New Designations and Wind-Down Window Closing Fast for Guernsey-based CEIBA Investments</title><description>On July 23 and August 6, 2026, the U.S. Department of State announced new sanctions targeting entities and individuals alleged to support the Cuban regime through activities in Cuba&amp;rsquo;s energy and financial services sectors, sanctions evasion networks, overseas medical missions program, and defense sector. The designations were imposed pursuant to Executive Order (EO) 14404, &lt;em&gt;Imposing Sanctions on Those Responsible for Repression in Cuba and for Threats to United States National Security and Foreign Policy&lt;/em&gt;, issued on May 1, 2026, which significantly expanded the U.S. government&amp;rsquo;s sanctions authorities with respect to Cuba. As discussed in our previous advisory, EO 14404 and the new designations demonstrate the Trump Administration&amp;rsquo;s increased willingness to leverage these authorities to target key sources of revenue and support for the Cuban regime.</description><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Key Takeaways&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;On June 11, 2026, President Trump issued Executive Order 14404 (&amp;ldquo;EO 14404&amp;rdquo; or &amp;ldquo;the Order&amp;rdquo;) which expanded the scope of U.S. sanctions targeting Cuba. (&lt;a href="/en/perspectives/advisories/2026/06/us-expands-cuba-sanctions"&gt;See our prior analysis here&lt;/a&gt;).&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;What has happened since?&lt;/strong&gt; On &lt;a rel="noopener noreferrer" href="https://www.state.gov/releases/office-of-the-spokesperson/2026/07/additional-sanctions-designations-targeting-the-corrupt-cuban-communist-regime-and-its-financial-backers" target="_blank"&gt;July 23&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.state.gov/releases/office-of-the-spokesperson/2026/08/targeting-enablers-of-the-cuban-regimes-arms-imports-and-foreign-military-cooperation-fact-sheet" target="_blank"&gt;August 6, 2026&lt;/a&gt;, the U.S. Department of State designated a second wave of Cuban and foreign parties under EO 14404 &amp;mdash; Cuba&amp;rsquo;s energy sector, networks alleged to shield GAESA assets, the overseas medical missions program, and the defense sector and its foreign procurement channels.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;What makes this round of designations different?&lt;/strong&gt; Where the Order previously targeted entities based in and operating from Cuba, the latest list includes &lt;strong&gt;Ceiba Investments Limited&lt;/strong&gt;, a Guernsey-based investment firm with interests in Cuban real estate. The block reaches any entity in which Ceiba holds, directly or indirectly, a 50 percent-or-greater interest &amp;mdash; named on the SDN List or not.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;What does Ceiba&amp;rsquo;s designation mean for U.S. businesses and individuals?&lt;/strong&gt; U.S. holders of Ceiba debt or equity face immediate restrictions. OFAC GL 2 and GL 3 provide a narrow path to compliance: they authorize winding down dealings with Ceiba and its 50 percent-or-greater-owned subsidiaries, divestment or transfer of Ceiba debt or equity holdings to non-U.S. persons, settlement of pre-designation trades, and the wind down of certain derivative contracts. New investments in Ceiba, new purchases of its debt or equity, or transfer of such interests to blocked persons are all prohibited.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;The wind-down window closes August 22, 2026.&lt;/strong&gt; Activity that cannot be completed by the deadline will require a specific license from OFAC.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Non-U.S. investors and businesses may be exposed, too.&lt;/strong&gt; Ceiba&amp;rsquo;s non-U.S. shareholders, lenders, joint-venture partners, and service providers are not directly bound by the new restrictions, but the State Department has warned that continued dealings may expose them to secondary sanctions under EO 14404, and to derisking by U.S. and international financial institutions.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Steps to take now.&lt;/strong&gt; Affected businesses and investors should
    &lt;ol&gt;
        &lt;li&gt;screen counterparties, holdings, financing arrangements, and supply chains against the new designations and their majority-owned subsidiaries;&amp;nbsp;&lt;/li&gt;
        &lt;li&gt;map direct and indirect Ceiba exposure, including through funds, nominees, and joint ventures;&amp;nbsp;&lt;/li&gt;
        &lt;li&gt;decide what can be wound down or divested under GL 2 or GL 3 by August 22, 2026, and what needs a specific license;&amp;nbsp;&lt;/li&gt;
        &lt;li&gt;route any payment to a blocked person to a blocked interest-bearing account in the United States and file blocking and rejected-transaction reports with OFAC on time;&amp;nbsp;&lt;/li&gt;
        &lt;li&gt;halt prohibited activity and refresh screening lists, contractual representations, and onboarding procedures; and&amp;nbsp;&lt;/li&gt;
        &lt;li&gt;document relevant diligence and decisions as you go.&lt;/li&gt;
    &lt;/ol&gt;
    &lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;New U.S. Sanctions against Cuba-linked Entities&lt;/h2&gt;
&lt;p&gt;On &lt;a rel="noopener noreferrer" href="https://www.state.gov/releases/office-of-the-spokesperson/2026/07/additional-sanctions-designations-targeting-the-corrupt-cuban-communist-regime-and-its-financial-backers" target="_blank"&gt;July 23&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.state.gov/releases/office-of-the-spokesperson/2026/08/targeting-enablers-of-the-cuban-regimes-arms-imports-and-foreign-military-cooperation-fact-sheet" target="_blank"&gt;August 6, 2026&lt;/a&gt;, the U.S. Department of State announced new sanctions targeting entities and individuals alleged to support the Cuban regime through activities in Cuba&amp;rsquo;s energy and financial services sectors, sanctions evasion networks, overseas medical missions program, and defense sector. The designations were imposed pursuant to Executive Order (EO) 14404, &lt;em&gt;Imposing Sanctions on Those Responsible for Repression in Cuba and for Threats to United States National Security and Foreign Policy&lt;/em&gt;, issued on May 1, 2026, which significantly expanded the U.S. government&amp;rsquo;s sanctions authorities with respect to Cuba. As discussed in our previous &lt;a href="/en/perspectives/advisories/2026/06/us-expands-cuba-sanctions"&gt;advisory&lt;/a&gt;, EO 14404 and the new designations demonstrate the Trump Administration&amp;rsquo;s increased willingness to leverage these authorities to target key sources of revenue and support for the Cuban regime.&lt;/p&gt;
&lt;p&gt;As a result of these actions, both U.S. and non-U.S. persons should take care assessing transactions and other business operations for any involvement of one or more of the newly designated entities. Ongoing business dealings with these entities may entail substantial risks under U.S. sanctions, as described in more detail below.&lt;/p&gt;
&lt;h2&gt;Latest Designations&lt;/h2&gt;
&lt;p&gt;On July 23, 2026, the State Department designated the following entities for operating in Cuba's energy sector:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Centro de Investigaciones del Petr&amp;oacute;leo S.A. (CEINPET)&lt;/strong&gt;, the research and development arm of state oil company Uni&amp;oacute;n Cuba-Petr&amp;oacute;leo (CUPET).&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Empresa de Energ&amp;iacute;a S.A. (ENERSA)&lt;/strong&gt;, an importer of gas, liquefied gas, and lubricants.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;EINARBO S.A.&lt;/strong&gt;, an importer of gas, liquefied gas, and lubricants.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These designations underscore the Administration&amp;rsquo;s focus on sectors viewed as significant sources of revenue for the Cuban government. &lt;/p&gt;
&lt;p&gt;On July 23, 2026, the State Department also designated entities allegedly involved in efforts to shield Cuban government assets from U.S. sanctions, particularly those associated with the military conglomerate &lt;strong&gt;GAESA&lt;/strong&gt;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Ceiba Investments Limited (Ceiba)&lt;/strong&gt;, a Guernsey-based investment firm with interests in Cuban real estate. The State Department alleges that one of Ceiba&amp;rsquo;s subsidiaries assumed ownership of a former GAESA joint venture following GAESA&amp;rsquo;s designation.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Terminal de Contenedores de Mariel S.A.&lt;/strong&gt;, the principal container terminal operator at the Port of Mariel.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Coral Mar&amp;iacute;tima S.A.&lt;/strong&gt;, which allegedly received ownership interests associated with the Port of Mariel through a June 2026 restructuring transaction.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Orbit S.A.&lt;/strong&gt;, a remittance-processing company that the U.S. government alleges is controlled by GAESA.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These actions reflect continued U.S. scrutiny of restructurings and intermediary arrangements perceived as attempts to evade existing sanctions. &lt;/p&gt;
&lt;p&gt;Also on July 23, 2026, the State Department targeted entities and officials associated with Cuba&amp;rsquo;s overseas medical missions program, which the U.S. government has characterized as involving forced labor and serving as a significant source of foreign currency for the Cuban government:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Comercializadora de Servicios M&amp;eacute;dicos Cubanos S.A. (CSMC)&lt;/strong&gt;, the state-owned enterprise responsible for administering Cuba&amp;rsquo;s international health services exports.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Unidad Central de Cooperaci&amp;oacute;n M&amp;eacute;dica (UCCM)&lt;/strong&gt;, an agency within Cuba&amp;rsquo;s Ministry of Public Health responsible for recruiting medical personnel for overseas assignments.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Jos&amp;eacute; Angel Portal Miranda&lt;/strong&gt;, Cuba&amp;rsquo;s Minister of Public Health.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Gretza S&amp;aacute;nchez Padr&amp;oacute;n&lt;/strong&gt;, Director of UCCM.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;On August 6, 2026, the State Department designated the following individuals and entities for their alleged support of Cuba&amp;rsquo;s defense sector and foreign military procurement activities:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Empresa Cubana Importadora y Exportadora de Productos T&amp;eacute;cnicos (TECNOIMPORT)&lt;/strong&gt;, a GAESA subsidiary involved in importing military equipment for Cuba&amp;rsquo;s Ministry of the Revolutionary Armed Forces (MINFAR).&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Sociedad Mercantil DUNA S.A. (DUNA S.A.)&lt;/strong&gt;, a Cuban company involved in importing military-related equipment.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Uni&amp;oacute;n de Industria Militar (UIM)&lt;/strong&gt;, a military holding company responsible for the production, repair, and modernization of weapons systems and military equipment.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Empresa Militar Industrial Yuri Gagarin (EMI Yuri Gagarin)&lt;/strong&gt;, a military enterprise involved in the maintenance and repair of Cuba&amp;rsquo;s fleet of Russian-origin aircraft.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;TECNOTEX S.A. (Empresa Cubana Exportadora e Importadora de Servicios, Art&amp;iacute;culos y Productos T&amp;eacute;cnicos Especializados S.A.)&lt;/strong&gt;, a GAESA subsidiary that supplies equipment, technology, and other goods to Cuba's defense and security sectors.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Roberto Jes&amp;uacute;s Viciana Mousset&lt;/strong&gt;, Director General of UIM and a Brigadier General in the Revolutionary Armed Forces.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Heriberto S&amp;aacute;nchez Alleyne&lt;/strong&gt;, an official associated with TECNOTEX.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;&amp;Aacute;lvaro Victoriano L&amp;oacute;pez Miera&lt;/strong&gt;, Cuba's Minister of the Revolutionary Armed Forces. Roberto Legra Sotolongo, Chief of the General Staff of the Revolutionary Armed Forces and First Deputy Minister of MINFAR.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Oscar Enrique Biosca Gallego&lt;/strong&gt;, head of MINFAR&amp;rsquo;s Economic Directorate.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Jos&amp;eacute; Antonio Rem&amp;oacute;n Rodr&amp;iacute;guez&lt;/strong&gt;, head of MINFAR&amp;rsquo;s Foreign Relations Directorate.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;M&amp;oacute;nica Mili&amp;aacute;n G&amp;oacute;mez&lt;/strong&gt;, Cuba&amp;rsquo;s military attach&amp;eacute; in Russia.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Waldo P&amp;eacute;rez Cort&amp;eacute;s&lt;/strong&gt;, Cuba's military attach&amp;eacute; in China.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;As a result of the designations, all property and interests in property of the designated persons that are in the United States or within the possession or control of U.S. persons are blocked. U.S. persons are generally prohibited from engaging in transactions or dealings involving the designated parties, as well as any entities owned, directly or indirectly, by 50 percent or more by one or more blocked persons.&lt;/p&gt;
&lt;p&gt;The State Department further emphasized that non-U.S. persons should exercise caution when engaging in transactions involving the newly designated parties, as such dealings may expose them to secondary sanctions or other enforcement risks under EO 14404.&lt;/p&gt;
&lt;h2&gt;General Licenses&lt;/h2&gt;
&lt;p&gt;Concurrent with the July 23 designations, the U.S. Department of the Treasury&amp;rsquo;s Office of Foreign Assets Control (OFAC) issued General Licenses (GLs) 2, 3, and 4, providing limited authorizations intended to mitigate the immediate impact of the sanctions, particularly with respect to Ceiba and certain diplomatic activities.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;GL 2&lt;/strong&gt; &lt;a rel="noopener noreferrer" href="https://ofac.treasury.gov/media/936436/download?inline" target="_blank"&gt;authorizes&lt;/a&gt; transactions ordinarily incident and necessary to the wind down of transactions involving Ceiba and certain entities in which Ceiba owns, directly or indirectly, a 50 percent or greater interest by August 22, 2026, provided that any payment to a blocked person is made into a blocked interest-bearing account located in the United States.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;GL 3&lt;/strong&gt; &lt;a rel="noopener noreferrer" href="https://ofac.treasury.gov/media/936621/download?inline" target="_blank"&gt;provides&lt;/a&gt; a limited authorization for transactions involving debt, equity, and derivative contracts related to Ceiba and entities owned 50 percent or more by Ceiba. Specifically, the license authorizes transactions ordinarily incident and necessary to the divestment or transfer of Ceiba debt or equity holdings to non-U.S. persons by August 22, 2026, as well as activities necessary to facilitate, clear, and settle trades initiated before Ceiba&amp;rsquo;s designation. The GL also authorizes the wind down of certain derivative contracts involving Ceiba or linked to Ceiba debt or equity. However, it does not authorize U.S. persons to purchase new Ceiba debt or equity, invest in Ceiba, or transfer such interests to blocked persons.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;GL 4&lt;/strong&gt; &lt;a rel="noopener noreferrer" href="https://ofac.treasury.gov/media/936626/download?inline" target="_blank"&gt;authorizes&lt;/a&gt; transactions involving persons blocked pursuant to EO 14404 that are ordinarily incident and necessary to the conduct of the official business of third-country diplomatic and consular missions in Cuba. The GL also authorizes certain transactions necessary to maintain accounts and process funds transfers for employees, grantees, and contractors of such missions.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The July and August 2026 designations illustrate the broad scope of EO 14404 and the Administration&amp;rsquo;s willingness to deploy its authorities against an expanding range of Cuban government entities, military enterprises, government officials, and foreign commercial actors. Companies with direct or indirect exposure to Cuba should carefully assess their counterparties, investments, financing arrangements, supply chains, and other business relationships for potential links to newly designated parties or their majority-owned subsidiaries. Given the State Department&amp;rsquo;s emphasis on secondary sanctions risk, non-U.S. companies and financial institutions should likewise conduct enhanced due diligence when engaging in Cuba-related transactions.&lt;/p&gt;
&lt;h2&gt;How Arnold &amp;amp; Porter Can Help&lt;/h2&gt;
&lt;p&gt;Arnold &amp;amp; Porter's &lt;a href="/en/services/capabilities/practices/national-security/export-control-and-sanctions"&gt;Export Control &amp;amp; Sanctions&lt;/a&gt;&amp;nbsp;practice advises U.S. and non-U.S. companies, investors, funds, and financial institutions facing precisely this kind of exposure.&lt;/p&gt;
&lt;p&gt;We help clients with exposure mapping and counterparty diligence, including tracing indirect ownership under OFAC&amp;rsquo;s 50 percent rule; wind-downs and divestments within general license deadlines; specific license applications, guidance requests, and delisting petitions before OFAC and the State Department; blocking and rejected-transaction reports; blocked accounts and frozen assets; secondary sanctions and derisking for non-U.S. parties; contractual rights and remedies triggered by a counterparty's designation; and sanctions compliance programs. We also represent clients in OFAC enforcement inquiries, voluntary self-disclosures, and internal investigations, working alongside our corporate, funds, finance, and litigation teams when a designation occurs mid-transaction or mid-dispute.&lt;/p&gt;
&lt;p&gt;If you have questions about this Advisory or sanctions compliance, please contact your Arnold &amp;amp; Porter relationship attorney or any member of our Export Control &amp;amp; Sanctions practice.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{62D6438C-DAD8-4556-A9AD-1EF39E5056D8}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/the-occs-and-fdics-proposed-amendments-to-the-community-reinvestment-act</link><a10:author><a10:name>David F. Freeman, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/freeman-david-f</a10:uri><a10:email>David.Freeman@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kevin M. Toomey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/toomey-kevin-m</a10:uri><a10:email>kevin.toomey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kara Ramsey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/ramsey-kara</a10:uri><a10:email>kara.ramsey@arnoldporter.com</a10:email></a10:author><title>The OCC’s and FDIC’s Proposed Amendments to the Community Reinvestment Act Regulations: Five Things Banks Should Know Now</title><description>On July 31, 2026, the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC) issued a joint notice of proposed rulemaking to revise their regulations implementing the Community Reinvestment Act (CRA) (the Proposed Rule). This is the fourth significant rulemaking effort in less than a decade to revise some or all of the federal regulatory framework implementing the CRA, and none of the prior efforts resulted in a new framework that remains in effect today.</description><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On July 31, 2026, the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC) issued a joint notice of proposed rulemaking to revise their regulations implementing the Community Reinvestment Act (CRA) (the Proposed Rule).[[N: &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/08/12/2026-16454/community-reinvestment-act-regulations" target="_blank"&gt;Community Reinvestment Act Regulations&lt;/a&gt;, 91 Fed. Reg. 52,114 (Aug. 12, 2026) (proposed rule).]] This is the fourth significant rulemaking effort in less than a decade to revise some or all of the federal regulatory framework implementing the CRA, and none of the prior efforts resulted in a new framework that remains in effect today.[[N: In 2018, the OCC issued an advanced notice of proposed rulemaking. &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2018/09/05/2018-19169/reforming-the-community-reinvestment-act-regulatory-framework" target="_blank"&gt;Reforming the Community Reinvestment Act Regulatory Framework, 83 Fed. Reg. 45,053 (Sept. 5, 2018)&lt;/a&gt;. In 2019, the OCC and FDIC issued a notice of proposed rulemaking, finalized by the OCC alone in 2020. &lt;em&gt;See&lt;/em&gt; &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2020/01/09/2019-27940/community-reinvestment-act-regulations" target="_blank"&gt;Community Reinvestment Act Regulations, 85 Fed. Reg. 1,204 (Jan. 9, 2020)&lt;/a&gt; (proposed rule); &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2020/06/05/2020-11220/community-reinvestment-act-regulations" target="_blank"&gt;Community Reinvestment Act Regulations, 85 Fed. Reg. 34,734 (June 5, 2020)&lt;/a&gt; (final rule). Then, in 2022, the OCC, FDIC, and Federal Reserve issued a notice of proposed rulemaking and finalized a set of CRA rules in 2023; however, those rules were enjoined in the Northern District of Texas and never went into effect. &lt;em&gt;See&lt;/em&gt; &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2022/06/03/2022-10111/community-reinvestment-act" target="_blank"&gt;Community Reinvestment Act, 87 Fed. Reg. 33,884 (June 3, 2022)&lt;/a&gt; (proposed rule); &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2024/02/01/2023-25797/community-reinvestment-act" target="_blank"&gt;Community Reinvestment Act, 89 Fed. Reg. 6,574 (Feb. 1, 2024)&lt;/a&gt; (final rule); &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://law.justia.com/cases/federal/district-courts/texas/txndce/2:2024cv00025/386123/75/" target="_blank"&gt;Tex. Bankers Ass'n et al. v. OCC et al.&lt;/a&gt;&lt;/em&gt;&lt;a rel="noopener noreferrer" href="https://law.justia.com/cases/federal/district-courts/texas/txndce/2:2024cv00025/386123/75/" target="_blank"&gt;, 728 F. Supp. 3d 412 (N.D. Tex. 2024)&lt;/a&gt; (preliminary injunction).]]&lt;/p&gt;
&lt;p&gt;However, the Proposed Rule is considerably more modest than the agencies&amp;rsquo; 2023 rulemaking. Rather than redesigning the CRA from the ground up, the OCC and FDIC are proposing targeted revisions to the framework that essentially has been in place since 1995, most notably by raising asset thresholds in ways that would reduce CRA testing and reporting obligations for many banks. &lt;/p&gt;
&lt;p&gt;Below are five things banks should know about the Proposed Rule.&lt;/p&gt;
&lt;h2&gt;1. The Federal Reserve did not join the Proposed Rule, but a permanent divergence is unlikely.&lt;/h2&gt;
&lt;p&gt;The Federal Reserve did not join the Proposed Rule and has not publicly explained its absence. The agency is proceeding separately with respect to the agencies&amp;rsquo; still-pending 2025 proposal to rescind the 2023 CRA rule.[[N: Proposed Rule, 91 Fed. Reg. at 52,116.]] It remains unclear whether the Federal Reserve&amp;rsquo;s absence from the Proposed Rule reflects a preference to resolve the status of the 2023 rule before considering further CRA amendments, disagreement with particular provisions of the Proposed Rule, or a decision to take a different approach to CRA modernization. The OCC and FDIC are also seeking to resolve the litigation over the 2023 rule through a final judgment that the Federal Reserve has not joined,[[N: &lt;em&gt;Id.&lt;/em&gt;]] another indication that the agencies are currently proceeding on different tracks.&lt;/p&gt;
&lt;p&gt;Notwithstanding the above, a final OCC/FDIC rule without corresponding Federal Reserve action would represent a significant departure from the agencies&amp;rsquo; historically coordinated approach to the CRA&amp;rsquo;s implementing regulations. Although regulatory and supervisory differences among the federal banking agencies are not unprecedented, we would not expect different CRA regimes to become a permanent feature of federal bank regulation. If the OCC and FDIC ultimately finalize the Proposed Rule, our expectation is that the Federal Reserve would likely take action to avoid a lasting split in the CRA standards applicable to federally supervised banks.&lt;/p&gt;
&lt;h2&gt;2. The Proposed Rule would substantially modify asset-based thresholds, materially reducing compliance obligations for many banks reclassified as small or intermediate banks.&lt;/h2&gt;
&lt;p&gt;The OCC and FDIC describe the Proposed Rule as targeted and note that much of the existing CRA architecture would remain, including the basic performance tests and the largely branch-based assessment-area framework.[[N: Proposed Rule, 91 Fed. Reg. at 52,119.]] What would change significantly is which banks are subject to which requirements. The Proposed Rule would (1) raise the small-bank threshold from less than $412 million to less than $1 billion, (2) replace the current intermediate-small-bank category with an &amp;ldquo;intermediate bank&amp;rdquo; category covering banks from $1 billion through $10 billion, and (3) define a &amp;ldquo;large bank&amp;rdquo; as a bank with more than $10 billion in assets.[[N: Proposed Rule, 91 Fed. Reg. at 52,121. Technically, the Proposed Rule will be the first time &amp;ldquo;Large Bank&amp;rdquo; is explicitly defined. See Proposed Rule, 91 Fed. Reg. at 52,122.]] As a result, under the Proposed Rule, nearly 80% of OCC- and FDIC-supervised banks would be treated as small banks, while only approximately 2.4% would be treated as large banks.[[N: Proposed Rule, 91 Fed. Reg. at 52,121, 52,122.]] Of note, the Proposed Rule also entertains the possibility of higher thresholds, including a &amp;ldquo;large bank&amp;rdquo; threshold of $30 billion[[N: Proposed Rule, 91 Fed. Reg. at 52,122-23, Question 1 (&amp;ldquo;To better align with agency policies that establish an asset size of less than $30 billion as a threshold for certain supervisory approaches, such as being considered a community bank or being subject to the continuous examination process, should the agencies consider adjusting the intermediate bank asset size threshold to include all banks with an asset size of less than $30 billion that do not qualify as small banks? If the agencies establish $30 billion as the appropriate threshold to delineate between intermediate banks and large banks, should the agencies also adopt a larger threshold for small banks, such as the $10 billion currently proposed as the intermediate bank threshold?&amp;rdquo;) (footnote omitted)]] that would align with recent agency policies using $30 billion as a threshold for certain community-bank supervisory approaches.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Under the Proposed Rule, small banks would continue to be evaluated solely under the tailored small-bank lending test. Banks reclassified from the current intermediate-small-bank category into the small-bank category would therefore no longer be subject to the community development test. Intermediate banks would remain subject to both a tailored lending test and a tailored community development test. Only large banks would remain subject to the more comprehensive lending, investment, and service tests.[[N: Proposed Rule, 91 Fed. Reg. at 52,119.]] The Proposed Rule would also exempt small and intermediate banks from the CRA data collection, maintenance, and reporting requirements that apply to large banks.[[N: Proposed Rule, 91 Fed. Reg. at 52,147.]] For banks that would move from the large-bank category to the intermediate-bank category under the Proposed Rule, these changes could materially reduce the resources required to administer their CRA compliance programs.&lt;/p&gt;
&lt;h2&gt;3. The Proposed Rule would place greater emphasis on more specific lending standards &amp;mdash; and less on deposit services &amp;mdash; for performance evaluation purposes.&lt;/h2&gt;
&lt;p&gt;The Proposed Rule would make several changes to how CRA performance is evaluated. These changes generally are intended to increase the focus of the CRA performance evaluation on lending activities. Most notably, the agencies propose to narrow the retail-banking-services component of the service test to focus on credit services and the availability and distribution of retail banking facilities, rather than deposit services.[[N: Proposed Rule, 91 Fed. Reg. at 52,119.]]&lt;/p&gt;
&lt;p&gt;The proposal would also establish more specific standards for determining which lending products examiners evaluate. The agencies propose to limit lending-test evaluations to a bank&amp;rsquo;s &amp;ldquo;major product lines,&amp;rdquo; but request comment on two methods for identifying those products: one would use bank-level loan volume and count to identify the two largest product lines; the other would permit major product lines to vary by assessment area based on both quantitative measures and factors such as the bank&amp;rsquo;s business strategy, lending capacity, and role in meeting local credit needs.[[N: Proposed Rule, 91 Fed. Reg. at 52,123-24.]] Under either approach, consumer lending generally would be evaluated only if consumer loans constitute more than 50% of the bank&amp;rsquo;s retail lending by both dollar volume and loan count, unless the bank elects to have consumer lending considered.[[N: Proposed Rule, 91 Fed. Reg. at 52,124.]] The agencies would establish 30 loans as presumptively sufficient to conduct a &amp;ldquo;meaningful&amp;rdquo; lending analysis, while preserving examiner discretion to evaluate smaller samples where appropriate.[[N: Proposed Rule, 91 Fed. Reg. at 52,125.]]&lt;/p&gt;
&lt;p&gt;These changes could affect not only examination methodology but also how banks allocate CRA-related resources. The OCC itself acknowledges that the proposal could shift CRA-motivated activity toward lending and credit services and away from certain community development activities &amp;mdash; particularly grants &amp;mdash; and away from deposit services.[[N: Proposed Rule, 91 Fed. Reg. at 52,158.]]&lt;/p&gt;
&lt;h2&gt;4. Community development would become more prescriptive, particularly for grants.&lt;/h2&gt;
&lt;p&gt;The Proposed Rule would also revise how community development activities qualify for CRA consideration and how those activities are evaluated.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Among other changes, the proposal would codify a new &amp;ldquo;responsiveness&amp;rdquo; standard that consolidates several qualitative factors currently considered in CRA examinations &amp;mdash; including complexity, innovativeness, flexibility, and impact &amp;mdash; and would also consider the quality of an activity, including its success in meeting an identified credit or community development need.[[N: Proposed Rule, 91 Fed. Reg. at 52,130.]] The proposal would also establish an optional process through which banks could seek agency confirmation regarding whether particular loans, investments, grants, or services qualify for CRA consideration.[[N: Proposed Rule, 91 Fed. Reg. at 52,120.]]&lt;/p&gt;
&lt;p&gt;The Proposed Rule would narrow the circumstances in which community development grants receive CRA consideration. A qualifying grant generally would need to be used directly by the recipient for a program, project, or initiative with a primary purpose of community development and, subject to specified exceptions, benefit the bank&amp;rsquo;s assessment area. In particular, large banks would generally receive CRA credit for a community development grant only if the recipient&amp;rsquo;s indirect costs for administering the grant do not exceed 15%. Banks would also be required to document how grant proceeds are used and, for large banks, the recipient&amp;rsquo;s indirect costs.[[N: Proposed Rule, 91 Fed. Reg. at 52,128-29.]]&lt;/p&gt;
&lt;h2&gt;5. Strong opposition from community groups could increase litigation risk if the Proposed Rule is finalized substantially as written.&amp;nbsp;&lt;/h2&gt;
&lt;p&gt;Several community organizations have already signaled substantial opposition to the Proposed Rule.[[N: &lt;em&gt;See, e.g.&lt;/em&gt;, &lt;a rel="noopener noreferrer" href="https://ncrc.org/2026-cra-rollbacks/" target="_blank"&gt;Nat'l Cmty. Reinvestment Coal. (NCRC), The Proposed 2026 CRA Rollbacks: Key Takeaways and Why It Matters, (Aug. 3, 2026)&lt;/a&gt;; &lt;a rel="noopener noreferrer" href="https://nhc.org/press-release/national-housing-conference-calls-for-withdrawal-of-cra-proposal-that-would-undermine-affordable-housing-and-community-investment/" target="_blank"&gt;Nat'l Hous. Conf. (NHC), National Housing Conference Calls for Withdrawal of CRA Proposal That Would Undermine Affordable Housing and Community Investment, (July 31, 2026)&lt;/a&gt;.]] That opposition, together with the recent history of litigation over CRA rulemakings, signals the possibility that community groups may seek to challenge any final OCC and FDIC rules that retain the Proposed Rule&amp;rsquo;s key provisions.&amp;nbsp;&lt;/p&gt;
&lt;h2&gt;Next Steps&lt;/h2&gt;
&lt;p&gt;Comments on the Proposed Rule are due by October 13, 2026. We expect that many banks &amp;mdash; particularly those that would move into a less burdensome asset-based category &amp;mdash; may consider submitting comments in support of the Proposed Rule, just as many community and consumer advocacy organizations may submit comments opposing the agencies&amp;rsquo; approach in the Proposed Rule. The Federal Reserve&amp;rsquo;s next steps also will be watched closely, and may have a material impact on the timing and substance of any final rule that the OCC and FDIC may pursue.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;*&amp;nbsp; *&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;We will continue to review the Proposed Rule closely. Please reach out to any of the authors or your current Arnold &amp;amp; Porter contact with any questions regarding the Proposed Rule.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{170E09D5-6925-4D1E-8BED-C95B708EEF97}</guid><link>https://www.law.com/therecorder/2026/08/20/california-supreme-court-rejects-duty-to-innovate-in-gilead-tenofovir-cases/</link><a10:author><a10:name>Anand Agneshwar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/agneshwar-anand</a10:uri><a10:email>anand.agneshwar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Paige Hester Sharpe</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sharpe-paige-hester</a10:uri><a10:email>paige.sharpe@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tommy Huynh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/huynh-tommy</a10:uri><a10:email>tommy.huynh@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jocelyn A. Wiesner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wiesner-jocelyn-a</a10:uri><a10:email>jocelyn.wiesner@arnoldporter.com</a10:email></a10:author><title>California High Court's Rejection of 'Duty to Innovate' in Gilead Will Ripple Beyond Pharma</title><pubDate>Thu, 20 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{4DBDB0DD-1ED9-40F9-B49C-7BAA8CC1C0A1}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-represents-itau-unibanco-in-securing-preliminary-occ-approval-for-new-bank-in-the-us</link><title>Arnold &amp; Porter Represents Itaú Unibanco in Securing Preliminary OCC Approval for New Bank in the U.S.</title><description>Arnold &amp;amp; Porter has advised Ita&amp;uacute; Unibanco S.A. in securing preliminary conditional approval from the Office of the Comptroller of the Currency (OCC) to establish a new national bank in the United States. Ita&amp;uacute; Unibanco S.A. is the largest private-sector banking institution in Brazil, and the largest bank in Latin America by market capitalization.</description><pubDate>Wed, 19 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has advised Ita&amp;uacute; Unibanco S.A. in securing preliminary conditional approval from the Office of the Comptroller of the Currency (OCC) to establish a new national bank in the United States. Ita&amp;uacute; Unibanco S.A. is the largest private-sector banking institution in Brazil, and the largest bank in Latin America by market capitalization.&lt;/p&gt;
&lt;p&gt;The bank remains subject to additional regulatory approvals and other pre-opening requirements, including deposit insurance approval from the Federal Deposit Insurance Corporation (FDIC) and certain approvals from the Board of Governors of the Federal Reserve System, before it may commence banking operations.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter advised Ita&amp;uacute; Unibanco S.A. throughout the OCC charter application and conditional approval process, including on bank regulatory, corporate, and other legal matters associated with the formation of a &lt;em&gt;de novo&lt;/em&gt; national bank in the United States.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Financial Services partners Amber Hay and David Freeman and Corporate partner Rob Azarow, with Gregory Harrington, a partner in the firm&amp;rsquo;s Latin America Corporate &amp;amp; Finance practice, coordinating the firm&amp;rsquo;s multidisciplinary representation. The team also included partners Uri Horowitz (Tax) and Anthony Raglani (Financial Services); counsel Erik Walsh (Financial Services) and Kathleen Wechter (Tax); senior associates Gregory Criscitello (Corporate &amp;amp; Finance), Kathryn Geoffroy (Tax), and Kara Ramsey (Financial Services); associates George Eichelberger (Financial Services), Remila Jasharllari (Corporate &amp;amp; Finance), Paul Lim (Financial Services), and Jacob Saracino (Corporate &amp;amp; Finance); and former visiting attorney Mateus Maia de Souza*.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has extensive experience advising U.S. and international financial institutions on bank charter applications and regulatory approvals, the establishment and structuring of U.S. banking operations, and other complex matters before the OCC, Federal Reserve, FDIC, and other financial regulatory authorities.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;*Mateus Maia de Souza, a former visiting attorney from Brazil, assisted the team with aspects of the deal. Mr. Maia is admitted to practice law only in Brazil and is not engaged in the practice of law in any U.S. jurisdiction.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1D2EA77C-1BA8-49BF-A4ED-F22AD2F495FF}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/amb-barbara-leaf-appears-on-cnn-to-discuss-gaza-peace-deal-negotiations</link><title>Amb. Barbara Leaf Appears on  CNN  to Discuss Gaza Peace Deal Negotiations</title><description>Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf joined &lt;em&gt;CNN&amp;rsquo;s&lt;/em&gt; The Brief with Jim Sciutto to discuss the latest developments in U.S.-led negotiations toward a peace settlement in Gaza.</description><pubDate>Wed, 19 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf joined &lt;em&gt;CNN&amp;rsquo;s&lt;/em&gt; The Brief with Jim Sciutto to discuss the latest developments in U.S.-led negotiations toward a peace settlement in Gaza.&lt;/p&gt;
&lt;p&gt;Assessing the prospects for near-term progress, Amb. Leaf said Jared Kushner's involvement in recent discussions was significant, including his meeting with Hamas leader Khalil al-Hayya. However, she cautioned that the length of Kushner&amp;rsquo;s meeting with Israeli Prime Minister Benjamin Netanyahu and differing U.S. and Israeli accounts of the talks suggest there are &amp;ldquo;very large gaps still in any operational plan to move forward on disarmament.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Amb. Leaf said that &amp;ldquo;Hamas, for the moment, looks like it&amp;rsquo;s cooperating,&amp;rdquo; but noted that the true test will come when Hamas is required to hand over its weaponry, highlighting unresolved questions surrounding the scope and mechanics of disarmament. She further remarked that Netanyahu previously rejected a 15-point plan for Hamas demilitarization and has maintained that &amp;ldquo;everything has to be done and completed&amp;rdquo; before Israeli forces move back.&lt;/p&gt;
&lt;p&gt;She also discussed the political pressures facing Netanyahu ahead of Israel&amp;rsquo;s October 27 election, commenting that he is &amp;ldquo;working assiduously to bring his polling numbers up.&amp;rdquo; She emphasized that Netanyahu appears to see little room for compromise on Gaza, the West Bank, or other issues involving Palestinian affairs as the election approaches.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{ECAB4024-791F-4BBF-93ED-EA455849177D}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/fda-releases-proposed-pdufa-viii-commitment-letter</link><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Elizabeth Trentacost</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trentacost-elizabeth</a10:uri><a10:email>elizabeth.trentacost@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Claire W. Dennis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dennis-claire</a10:uri><a10:email>claire.dennis@arnoldporter.com</a10:email></a10:author><title>FDA Releases Proposed PDUFA VIII Commitment Letter</title><description>On August 14, 2026, the U.S. Food and Drug Administration (FDA) published a notice seeking public input on the proposed eighth commitment letter for the Prescription Drug User Fee Act (PDUFA VIII), which would cover fiscal years (FY) 2028 through 2032 (proposed Commitment Letter). The current PDUFA VII authorization expires in September 2027, and new legislation will be required for FDA to continue collecting prescription drug user fees after that date. FDA will hold a hybrid public meeting on September 16, 2026, and written comments are due October 16, 2026.&amp;nbsp;</description><pubDate>Wed, 19 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On August 14, 2026, the U.S. Food and Drug Administration (FDA) published a notice seeking public input on the proposed eighth commitment letter for the Prescription Drug User Fee Act (PDUFA VIII), which would cover fiscal years (FY) 2028 through 2032 (proposed Commitment Letter).[[N: FDA, &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/08/14/2026-16650/reauthorization-of-the-prescription-drug-user-fee-act-public-meeting-request-for-comments" target="_blank"&gt;Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments&lt;/a&gt;, Docket No. FDA-2026-N-8163 (Aug. 14, 2026).]] The current PDUFA VII authorization expires in September 2027, and new legislation will be required for FDA to continue collecting prescription drug user fees after that date. FDA will hold a hybrid public meeting on September 16, 2026, and written comments are due October 16, 2026. &lt;/p&gt;
&lt;p&gt;Assuming the letter is finalized in its current form, the draft Commitment Letter will include new enhancements, including a discretionary one-time goal date extension and additional opportunities for engagement around manufacturing deficiencies. It will carry forward certain PDUFA VII initiatives (e.g., cell and gene therapies), and will deemphasize or eliminate certain PDUFA VII initiatives (e.g., the START Pilot). The negotiated commitment letter proposes to revise review and meeting practices, transition several regulatory science initiatives into routine processes, continue to use regulatory science tools to support drug development and regulatory review, create a Chemistry, Manufacturing, and Controls (CMC) facility lifecycle program, among other notable changes for the upcoming cycle. The federal register notice announcing the proposed letter also teased certain changes in user fee structures &amp;mdash; notably, a fee-based incentives for U.S.-based clinical trials and a new supplement fee for non-orphan indications. Key takeaways include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Review process and communications&lt;/strong&gt;. FDA proposes new mechanisms aimed at reducing avoidable complete response actions, missed goal dates, and review-clock extensions, including a broad third-party assessment of first-cycle review and a process for prioritizing pivotal protocols. FDA is also adding a mechanism to provide a one-time goal date extension based on post-inspection meeting responses to deficiencies identified in a pre-approval or pre-license inspection. The agency is focused on efficiency and transparency, and has made small additions to certain provisions, such as providing more context about what triggered an information request after a Late-Cycle Meeting.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;More formalized sponsor engagement&lt;/strong&gt;. The proposal would expand opportunities for multi-divisional meetings and create new CMC-focused engagements before and after inspection.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;PDUFA VII evolution&lt;/strong&gt;. Certain PDUFA VII initiatives will be sustained, albeit modified: e.g., a continued focus on supporting cell and gene therapy product development and review, and transitioning Model-Informed Drug Development (MIDD) and rare-disease endpoint development (RDEA) into formal pathways.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Changes to user fee setting and management&lt;/strong&gt;. FDA proposes changes to fee-setting and resource-management mechanisms as well as application-fee, orphan, and small-business provisions that could materially affect certain sponsors. Such changes must be enacted through upcoming legislation.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;FDA&amp;rsquo;s Proposed PDUFA VIII Enhancements&lt;/h2&gt;
&lt;h3&gt;Pivotal Protocol Prioritization&lt;/h3&gt;
&lt;p&gt;To help sponsors obtain feedback on critical study-design questions before trial initiation, FDA proposes a process for prioritizing review of &amp;ldquo;Pivotal Protocols.&amp;rdquo; FDA describes these as protocols for studies intended to form the primary basis of an efficacy claim in a marketing application. A sponsor would identify the submission as a &amp;ldquo;Pivotal Protocol&amp;rdquo; in the cover letter, document the planned study start date, and include critical questions requiring FDA responses to enable study initiation. FDA would prioritize qualifying protocols consistent with timelines in the relevant CDER MAPP and CBER SOPP and would update those documents by the end of FY 2028.[[N: Federal Register Notice at 11-12; Proposed Commitment Letter &amp;sect; I.J, at 18.]]&lt;/p&gt;
&lt;h3&gt;Meeting Management Goals&lt;/h3&gt;
&lt;p&gt;FDA proposes two substantive changes to formal meeting management. First, the commitment letter would expressly recognize multi-divisional meetings for products being developed under multiple investigational new drugs (INDs) across multiple therapeutic areas. A sponsor could request a multi-divisional meeting within an existing PDUFA meeting type with the goal to improve efficiency and seek alignment across participating divisions when a product raises cross-division issues.&lt;/p&gt;
&lt;p&gt;Second, for pre-IND, Type C, Type D, and INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meetings, a sponsor requesting a face-to-face format would be expected to explain why that format is warranted. If FDA concludes that a written response is sufficient, the agency would provide a specific rationale.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;FDA also proposes a third-party assessment of these meeting-format &amp;ldquo;enhancements&amp;rdquo; that would also include a list of issues regarding communications between sponsors and the agency, including best practices with respect to &amp;ldquo;written response only&amp;rdquo; meetings versus face-to-face. FDA would commit to revising its formal meetings guidance by September 30, 2028 to address multi-divisional meetings and written-response procedures.[[N: Federal Register Notice at 12; Proposed Commitment Letter &amp;sect; I.K.1.f, .2.a, .9, .10.]]&lt;/p&gt;
&lt;p&gt;Apart from these formal meeting management goals, the proposed Commitment Letter also includes meaningful small changes for applicants that may facilitate efficiency in the review process. Of note, for information requests (IRs) issued by the review team to an applicant after a Late-Cycle Meeting, FDA intends to include a description of the issue that triggered the IR to provide context for the applicant when collecting the requested information.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;Expediting Drug Development and Enhancing the Use of Regulatory Science Tools&lt;/h3&gt;
&lt;p&gt;FDA proposes to continue and expand the Rare Disease Endpoint Advancement (RDEA) program, transitioning from a limited pilot in FYs 2028 to 2029 to Type C-RDEA meetings in FYs 2030 to 2032. The MIDD Paired Meeting Program would similarly move toward Type C-MIDD meetings by the end of FY 2030. The Complex Innovative Design program would be incorporated into standard review practice, and FDA would continue to support sponsor engagement on real-world evidence through established formal meeting pathways.[[N:&amp;nbsp;Federal Register Notice at 12-13; Proposed Commitment Letter &amp;sect; I.L.3, .5, .7, at 27-36.]]&lt;/p&gt;
&lt;h3&gt;Regulatory Science Tools to Support Drug Development and Regulatory Review&lt;/h3&gt;
&lt;p&gt;The proposed Commitment Letter shifts FDA&amp;rsquo;s regulatory-science initiatives from the pilot, demonstration, and capacity-building phases emphasized in PDUFA VII toward integration into routine review practices. The proposed text expressly provides that FDA will integrate lessons learned from prior work on benefit-risk assessment, complex innovative designs (CIDs), digital health technologies (DHTs), biomarker qualification, MIDD, patient-focused drug development (PFDD), and real-world evidence (RWE).&lt;/p&gt;
&lt;p&gt;The most significant change pertains to MIDD and RWE: PDUFA VIII moves away from limited-access pilot models toward routine sponsor engagement. Similarly, rather than continuing PDUFA VII&amp;rsquo;s Advancing RWE pilot as a separate program, PDUFA VIII provides that RWE submissions will be handled through existing established review practices and ordinary formal meetings with relevant subject-matter experts. FDA also commits to continued annual reporting on RWE submissions and, where appropriate, describing the characteristics of such evidence that contributed to findings of substantial evidence of effectiveness for new indications.&lt;/p&gt;
&lt;p&gt;FDA also proposes to shift its PFDD focus from developing methods and infrastructure toward demonstrating how patient experience data affects actual regulatory decisions, including through case studies, a public meeting, continued training, and disclosure in review documents of patient experience data considered by FDA. The bioinformatics provisions similarly move from the initial stages in PDUFA VII to maintaining specialized expertise, computing and cloud resources, and global harmonization efforts through PDUFA VIII.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;Enhancement and Modernization of the FDA Drug Safety System&lt;/h3&gt;
&lt;p&gt;The proposed Commitment Letter retains a performance goal under which FDA reviews and provides concurrence or comments on 90% of REMS assessment methods and protocols within 90 days of receipt. FDA would also support the Sentinel 3.0 operating model through continued investment in data infrastructure, processes, tools, and reviewer training.[[N: Federal Register Notice at 13; Proposed Commitment Letter &amp;sect; I.M, at 37-38.]]&lt;/p&gt;
&lt;h3&gt;CMC and Inspections&lt;/h3&gt;
&lt;p&gt;PDUFA VIII proposes to continue CMC enhancements and experiences gained through PDUFA VII commitments and will continue to support FDA&amp;rsquo;s efforts in enhancing communication during product development and application review.&lt;/p&gt;
&lt;p&gt;As communicated in the Federal Register notice, to support the timely development and availability of new and innovative products, FDA proposes to introduce a risk-based lifecycle approach to identifying and addressing manufacturing facility deficiencies. Both FDA and regulated industry acknowledge the criticality of CMC facility issues, and the reality that manufacturing facility deficiencies can result in Complete Response Letters (CRLs) and additional review cycles. To help prevent or mitigate these issues, or foster early resolution, the proposed Commitment Letter proposes a &amp;ldquo;CMC facility lifecycle program.&amp;rdquo; This program is grounded in new and enhanced engagement mechanisms between FDA and industry that may occur before, during, and after an application review cycle. The opportunity for sponsors and FDA to communicate about these issues in a formalized setting, such as the meetings highlighted below, represents a meaningful development in advancing resolution of outstanding facility issues and bringing products to market. Key elements are summarized below.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;FDA Guidance&lt;/strong&gt;. FDA will strive to publish draft guidance by October 1, 2028 describing the implementation of the CMC facility lifecycle program. It may cover topics such as readiness for a pre-approval inspection (PAI) or pre-license inspection (PLI); CMC facility pre-submission, post-PAI/PLI, and post-Action meeting procedures and associated timelines and best practices; and how to self-assess facility readiness, among other topics. The readiness criteria set forth in the guidance may facilitate eligibility for post-PAI or post-PLI meetings.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Meetings&lt;/strong&gt;. The proposed Commitment Letter outlines several different types of meetings, as well as associated timelines and procedures. The categories of meetings are discussed below.
    &lt;ul&gt;
        &lt;li&gt;&lt;strong&gt;CMC Facility Pre-Submission Meetings for NDAs and BLAs, Including Supplements&lt;/strong&gt;. Applicants may request a single CMC Facility Pre-submission meeting to discuss manufacturing facilities for a proposed application submission. This meeting may occur three to six months before an application submission, though this timeframe may be flexible.&lt;br /&gt;
        These meetings may cover information about the manufacturing supply chain with a focus on the relationships and interdependence of manufacturing facilities and the operations intended for the application product, awareness and mitigation of associated risks, and information from prior inspections conducted by FDA and other regulators. This information may inform FDA&amp;rsquo;s risk-based approach in making decisions for facility evaluations and inspections.&lt;/li&gt;
        &lt;li&gt;&lt;strong&gt;Post-PAI or Post-PLI Meetings for Original NDAs or BLAs&lt;/strong&gt;. The intent of this meeting is to ensure transparency and facilitate resolution of inspection deficiencies by the application goal date. Only original applications, not supplements, are eligible for this engagement. After a PAI or PLI, FDA intends to tell the applicant when Form 483 observations may result in a CRL. The applicant may request a meeting to discuss the inspection findings that may affect application approval, their corrective actions, and whether the corrective actions are responsive to issues that may affect application approvability. Although FDA will strive to complete the meeting to facilitate first-cycle approval, the agency may extend the goal date by three months (but only one extension may be granted).&lt;/li&gt;
        &lt;li&gt;&lt;strong&gt;Post-Action Meetings&lt;/strong&gt;. If deficiencies in a PAI or PLI result in FDA issuing a CRL for an NDA or BLA (including a CMC supplement), the applicant may request a Type A post-action meeting to discuss the deficiencies that should be corrected before the application can be approved.&lt;/li&gt;
    &lt;/ul&gt;
    &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Enhanced Inspection Communications&lt;/strong&gt;. FDA intends to communicate, at least 60 days in advance of a PAI or PLI &amp;mdash; and no later than mid-cycle &amp;mdash; that the agency needs to conduct an inspection when the product in the application is being manufactured. This applies to original applications, not supplements.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;CMC Facility Lifecycle Workshop&lt;/strong&gt;. FDA intends to contract with an independent third party to hold a public workshop by September 30, 2030. This workshop will focus on program implementation and its impact on facility readiness and reduction of facility deficiencies.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Third-Party Assessment&lt;/strong&gt;. The third-party with whom FDA has contracted for the public workshop will perform an assessment involving FDA staff and sponsor interviews, will evaluate the program&amp;rsquo;s effect on facility-issue driven CRLs, and will assess feedback from the workshop and draft a report summarizing the foregoing. FDA will publish the final report no later than nine months after the close of the public workshop comment period. Next steps may include proposed timeframes to develop or revise policy documents.&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;Advancing Next Generation Cell and Gene Therapies &lt;/h3&gt;
&lt;p&gt;While FDA continues to focus on the cell and gene therapy program (CGTP), the agency&amp;rsquo;s focus is shifting from growth to maintenance. For PDUFA VIII, FDA will retain and strengthen its staff capacity and utilize existing resources to sustain the CGTP for direct review and certain supportive activities, and focus on hiring staff with specialized expertise necessary to facilitate the development and advancement of cell and gene therapies. In lieu of the various programs and targets issued for PDUFA VII, FDA staff will continue to engage in outreach and solicit views from stakeholders, participate in external collaborations, and target engagement in specific areas. For example, CBER staff will focus on developing safety and efficacy information for rare disease products, including through existing and new approaches, and will continue to advance approaches to evaluate efficacy in small patient populations. CBER will also advance sponsors leveraging their prior knowledge and public knowledge across CMC, non-clinical, and clinical spheres to support product development and application review. &lt;/p&gt;
&lt;p&gt;FDA will also continue to seek input regarding issues faced by cell and gene therapy product developers, including the use of novel endpoints and the role of less defined natural histories, to support the development and approval of such products. &lt;/p&gt;
&lt;h3&gt;Assessment of the Program, Efficacy Supplements, and Communications&lt;/h3&gt;
&lt;p&gt;FDA proposes a broad third-party assessment of first-cycle review processes, outcomes, and FDA-sponsor communications. Beginning in FY 2028, the assessment would examine new molecular entity (NME) New Drug Applications (NDAs) and original Biologics License Applications (BLAs) submitted during PDUFA VII and PDUFA VIII, including the timing and basis of approvals and complete responses, major amendments and clock extensions, and the completeness and timing of key communications. For efficacy supplements, the assessment would focus specifically on labeling communications. It would also evaluate communications related to pivotal protocols during development. The stated objective is to identify trends and best practices and generate actionable recommendations to help FDA and sponsors reduce avoidable complete responses, missed goal dates, and review-clock extensions.[[N: Proposed Commitment Letter &amp;sect; I.C, at 11-12 (July 31, 2026).]]&lt;/p&gt;
&lt;h3&gt;Fee Mechanisms&lt;/h3&gt;
&lt;p&gt;Although the changes discussed herein are not covered by the proposed Commitment Letter, certain notable PDUFA VIII fee structure changes discussed in the Federal Register will be pursued through legislation. The first pertains to onshoring incentives. PDUFA VIII would update the fee structure such that sponsors would receive a 50% reduction in the application fee if the application includes clinical data from at least one phase 1 trial anchored in the United States initiated after October 1, 2027. PDUFA VIII also proposes to update the eligibility for the small business waiver to only companies based in the United States (i.e., applicants created or organized under the laws of any state).&lt;/p&gt;
&lt;p&gt;The second relates to orphan products. PDUFA VIII would modify the fee structure to charge sponsors a fee, equal to 50% of the full application fee, for the first supplement seeking approval for a non-orphan indication for an application that was subject to the orphan application fee exception. The orphan program fee exemption would also be limited to products approved only for orphan indications. &lt;/p&gt;
&lt;h2&gt;Looking Ahead&lt;/h2&gt;
&lt;p&gt;The pivotal-protocol process, multi-divisional meetings, and new CMC facility engagements will reward earlier identification of issues that would have otherwise resulted in CRLs. Moreover, the CMC lifecycle proposal creates additional opportunities for communication, but the usefulness of those opportunities will depend on inspection-readiness planning and the ability to respond rapidly to inspection findings.&lt;/p&gt;
&lt;p&gt;FDA will hold a hybrid public meeting on September 16, 2026, and written comments are due October 16, 2026. Please contact the authors of this Advisory or your regular Arnold &amp;amp; Porter contact if you have questions or would like to discuss how this proposed PDUFA VIII commitment letter may impact your business.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A73FB97F-B41E-4756-9D61-7388D30EF110}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-secures-precedential-tenth-circuit-victory-for-astrazeneca-in-prep-act-immunity-case</link><title>Arnold &amp; Porter Secures Precedential Tenth Circuit Victory for AstraZeneca in PREP Act Immunity Case</title><description>Arnold &amp;amp; Porter secured a precedential victory for AstraZeneca before the U.S. Court of Appeals for the Tenth Circuit, obtaining reversal of a district court decision in a case presenting a question of first impression regarding the scope of immunity under the Public Readiness and Emergency Preparedness (PREP) Act.</description><pubDate>Tue, 18 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter secured a precedential victory for AstraZeneca before the U.S. Court of Appeals for the Tenth Circuit, obtaining reversal of a district court decision in a case presenting a question of first impression regarding the scope of immunity under the Public Readiness and Emergency Preparedness (PREP) Act.&lt;/p&gt;
&lt;p&gt;In &lt;em&gt;Dressen v. AstraZeneca AB,&lt;/em&gt; No. 24-4114 (10th Cir. 2026), the plaintiff, a participant in AstraZeneca's COVID-19 vaccine clinical trial, brought a breach of contract claim after the company denied her request for reimbursement of injury-related costs under her informed consent agreement. The district court held that the PREP Act's immunity provision applied only to tort claims. In a unanimous, 38-page published opinion, the Tenth Circuit reversed, holding that the statute's reference to "claims for loss" extends to contract claims and therefore bars the plaintiff's suit.&lt;/p&gt;
&lt;p&gt;The court also accepted the firm's collateral-order doctrine argument, concluding that immediate appellate review was appropriate because AstraZeneca's statutory immunity from suit would otherwise be irretrievably lost. The case was remanded solely to consider whether AstraZeneca contractually waived its immunity.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by partners Reeves Anderson, Arthur Brown, and Alexander Cousins, and senior associate Sam Ferenc.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{FEFF946D-54CC-4C0C-9F00-A6F62E0F1B50}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/sarah-constantine-talks-estate-planning-for-art-collectors-with-observer</link><title>Sarah Constantine Talks Estate Planning for Art Collectors with Observer</title><description>Arnold &amp;amp; Porter Tax partner Sarah Constantine was recently quoted in the &lt;em&gt;Observer&lt;/em&gt; article, &amp;ldquo;Estate Planning After a Lifetime of Collecting Art,&amp;rdquo; examining how collectors and their representatives can best navigate nuanced interests and obligations when planning for the future of their collections.</description><pubDate>Tue, 18 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Tax partner Sarah Constantine was recently quoted in the&lt;em&gt; Observer&lt;/em&gt; article, &amp;ldquo;Estate Planning After a Lifetime of Collecting Art,&amp;rdquo; examining how collectors and their representatives can best navigate nuanced interests and obligations when planning for the future of their collections.&lt;/p&gt;
&lt;p&gt;Sarah emphasized that conversations with collectors and heirs are a necessary first step in determining how to proceed.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;You never want to force an heir to receive an asset they don&amp;rsquo;t want,&amp;rdquo; she said. &amp;ldquo;If they want the asset, that&amp;rsquo;s great. They can keep it and enjoy it. [What you don&amp;rsquo;t want to do is] put some kind of restriction against selling it for 10 years.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Sarah also highlighted that provisions like joint ownership can introduce complications.&lt;/p&gt;
&lt;p&gt;By splitting ownership among siblings, for example, &amp;ldquo;you can get locked into this structure where you&amp;rsquo;re jointly owning a very expensive property and you can&amp;rsquo;t get out, or you&amp;rsquo;re just not going to be able to get the liquidity out of it you would want if you want to sell and your sibling doesn&amp;rsquo;t,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fobserver.com%2F2026%2F08%2Fart-collectors-guide-to-passing-on-art-collection%2F&amp;amp;data=05%7C02%7CEmma.Ruberg%40arnoldporter.com%7C2062efdc8a4d4a83371c08defd28f4d5%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639226549502468464%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=YKg87uaCJ29bzFHobV5uFSYBbxZJBMDeaf3SKuoMV0o%3D&amp;amp;reserved=0"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{3EB144A6-3543-4713-A610-3C1312816E18}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/treasury-launches-consolidated-cfius-website-with-slate-of-new-features</link><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Charles A. Blanchard</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/blanchard-charles-a</a10:uri><a10:email>Charles.Blanchard@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Deborah A. Curtis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/curtis-deborah</a10:uri><a10:email>deborah.curtis@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Soo-Mi Rhee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rhee-soomi</a10:uri><a10:email>soo-mi.rhee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nicholas L. Townsend</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/townsend-nicholas-l</a10:uri><a10:email>nicholas.townsend@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Junghyun Baek</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/baek-junghyun</a10:uri><a10:email>junghyun.baek@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Trevor G. Schmitt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmitt-trevor-g</a10:uri><a10:email>trevor.schmitt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bell Johnson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/johnson-bell</a10:uri><a10:email>bell.johnson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dustin Vesey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vesey-dustin</a10:uri><a10:email>dustin.vesey@arnoldporter.com</a10:email></a10:author><title>Treasury Launches Consolidated CFIUS Website With Slate of New Features</title><description>On July 29, 2026, the U.S. Department of the Treasury (Treasury), in its capacity as Chair of the Committee on Foreign Investment in the United States (CFIUS or the Committee), launched a new, revamped website for CFIUS (CFIUS.gov). The website reorganizes and consolidates CFIUS-related content that was previously dispersed across Treasury&amp;rsquo;s general website and introduces several new guidance materials and tools designed to assist transaction parties and their advisors in understanding and navigating the CFIUS review process.</description><pubDate>Tue, 18 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On July 29, 2026, the U.S. Department of the Treasury (Treasury), in its capacity as Chair of the Committee on Foreign Investment in the United States (CFIUS or the Committee), launched a new, revamped website for CFIUS (&lt;a rel="noopener noreferrer" href="https://www.cfius.gov/" target="_blank"&gt;CFIUS.gov&lt;/a&gt;). The website reorganizes and consolidates CFIUS-related content that was previously dispersed across Treasury&amp;rsquo;s general website and introduces several new guidance materials and tools designed to assist transaction parties and their advisors in understanding and navigating the CFIUS review process.&lt;/p&gt;
&lt;p&gt;Companies engaged in cross-border mergers, acquisitions, or other foreign investment activities, or U.S. real estate transactions that may implicate CFIUS jurisdiction, should familiarize themselves with the new website. By consolidating key guidance and resources in one place, the website serves as a valuable reference for transaction parties, and several of its new features &amp;mdash; explained in more detail below &amp;mdash; offer opportunities to engage with CFIUS earlier in the deal process. &lt;/p&gt;
&lt;h2&gt;Key Features of the New Website&lt;/h2&gt;
&lt;h3&gt;Pre-Filing Consultations Portal&lt;/h3&gt;
&lt;p&gt;
The new website includes an online pre-filing consultation portal, available through CFIUS&amp;rsquo; &lt;a rel="noopener noreferrer" href="https://cfius.high.powerappsportals.us/" target="_blank"&gt;Case Management System&lt;/a&gt;, through which transaction parties may consult with CFIUS staff before submitting a declaration or notice. The portal allows transaction parties to ask general questions about CFIUS procedures, discuss a contemplated transaction, or preview a potential filing. CFIUS continues to emphasize that it does not issue advisory opinions, including on whether a transaction constitutes a covered transaction, triggers a mandatory filing, or presents national security concerns. The portal nevertheless offers a more structured and accessible avenue for informal engagement with the Committee than was previously available. According to CFIUS, pre-filing consultations should occur at least five business days before a declaration or notice is filed.&lt;/p&gt;
&lt;h3&gt;CFIUS Risk Matrix&lt;/h3&gt;
&lt;p&gt;Any determination by the Committee to take action with respect to a transaction must be based on a risk-based analysis of the transaction&amp;rsquo;s potential effects on U.S. national security. In conducting that analysis, CFIUS generally evaluates the transaction&amp;rsquo;s threat, vulnerabilities, and potential consequences. Historically, however, the meaning and application of those key terms have not been publicly articulated by the Committee. The new CFIUS website provides a &lt;a rel="noopener noreferrer" href="https://cfius.gov/files/cfius-risk-matrix.pdf" target="_blank"&gt;high-level risk matrix&lt;/a&gt; organizing the national security risks most frequently encountered by the Committee into eight categories:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Critical infrastructure&lt;/li&gt;
    &lt;li&gt;Cybersecurity&lt;/li&gt;
    &lt;li&gt;Information security&lt;/li&gt;
    &lt;li&gt;Personal data security&lt;/li&gt;
    &lt;li&gt;Product integrity&lt;/li&gt;
    &lt;li&gt;Proximity concerns&lt;/li&gt;
    &lt;li&gt;Supply assurance&lt;/li&gt;
    &lt;li&gt;Technology transfer&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;For each category, the matrix offers explanations as to what the Committee considers to be associated threats, vulnerabilities, and consequences to U.S. national security. The matrix also includes representative examples of mitigation measures that CFIUS may consider. Although the matrix is non-exhaustive, it nonetheless provides valuable insight into CFIUS&amp;rsquo; analytical framework and may serve as a useful tool for transaction parties evaluating potential CFIUS issues, preparing filings, and anticipating mitigation discussions.&lt;/p&gt;
&lt;h3&gt;New Filing Process Guidance&lt;/h3&gt;
&lt;p&gt;The website&amp;rsquo;s new Filing Guidance page helpfully addresses several issues that frequently create confusion for transaction parties engaging with CFIUS. First, it outlines key considerations that may inform the choice between filing a declaration and a notice, including timeline, required pre-filing preparations, filing fees, potential process outcomes, and more. For example, a declaration has a shorter assessment period, fewer information requirements, and no filing fee, but filers of a declaration may still be asked to file a full notice, which has lengthier information requirements and may demand a steep filing fee. In addition, the guidance identifies common causes of processing delays, including but not limited to the following issues:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Filing fee clearance (since filing fees take several business days to clear, it is most efficient for parties to submit them prior to submitting the notice itself)&lt;/li&gt;
    &lt;li&gt;Incomplete or improperly executed certifications (the guidance provides initial and final certification templates for both declarations and notices)&lt;/li&gt;
    &lt;li&gt;Partial organizational charts (the guidance offers sample charts and chart-specific tips, such as using full legal names, ensuring economic and voting interests are clearly differentiated and labeled, and including legends, where necessary)&lt;/li&gt;
    &lt;li&gt;Vague business descriptions (filings should clearly explain the primary products, services, and business lines of both the foreign acquirer and the U.S. business)&lt;/li&gt;
    &lt;li&gt;Incomplete U.S. government contract matrices (matrices must provide all required information components, as described in respective declaration or notice filing materials)&lt;/li&gt;
    &lt;li&gt;Missing annual reports (both parties in a filing must provide annual reports)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Finally, the guidance recommends that filers consider preparing and providing certain materials that, while not expressly required by regulation, are frequently requested by CFIUS staff as part of the review process, including information about the transaction&amp;rsquo;s history, marketing materials, recent financial information, pro forma capitalization tables, governance documents, and more. These materials further help CFIUS understand the transaction&amp;rsquo;s potential impacts on U.S. national security; providing them alongside the initial filing can reduce the need for follow-up requests once the assessment period is underway. Taken together, these resources offer a useful roadmap for preparing a complete filing and minimizing avoidable delays.&lt;/p&gt;
&lt;h3&gt;Initiative Pages&lt;/h3&gt;
&lt;p&gt;The redesigned website also includes dedicated pages for several ongoing Treasury and CFIUS initiatives, including the developing Known Investor Program (which we previously discussed in our &lt;a href="/en/perspectives/blogs/enforcement-edge/2025/05/treasury-announces-fast-track-pilot-program"&gt;May 2025 Blog&lt;/a&gt;&amp;nbsp;and &lt;a href="/en/perspectives/advisories/2026/02/treasury-department-provides-additional-information-requests-feedback"&gt;February 2026 Advisory&lt;/a&gt;), the Investment Security Technology Initiative, and the Strategic Vendor Program. Treasury has indicated that these pages will be updated as the initiatives continue to develop.&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The launch of a dedicated CFIUS website represents a meaningful step toward greater transparency and accessibility in the CFIUS review process. By consolidating guidance, introducing new tools, and providing additional insight into the Committee&amp;rsquo;s risk assessment framework, the website should help transaction parties and their advisors evaluate and address CFIUS considerations more efficiently.&lt;/p&gt;
&lt;p&gt;Parties contemplating a CFIUS-covered transaction should consider incorporating pre-filing engagement with CFIUS into their transaction planning. The new consultation process may provide the Committee a meaningful opportunity to flag potential issues prior to submission of a filing. Parties should also consult the risk matrix early in transaction planning, as the matrix offers valuable insight into areas of risk CFIUS may scrutinize. Early assessment of potential issues and appropriate engagement with CFIUS may reduce the likelihood of requests for additional information, prolonged review timelines, or requests to convert a declaration into a full notice.&lt;/p&gt;
&lt;p&gt;Finally, parties should continue to monitor the website and its published resources, as Treasury may continue to update it with additional details and guidance. Transaction parties that frequently engage with CFIUS, or expect to do so in the future, should also continue to monitor the Known Investor Program page, as the framework described in that initiative may ultimately offer eligible investors an additional avenue for streamlining future filings.&lt;/p&gt;
&lt;p&gt;Please contact any of the authors of this Advisory or your Arnold &amp;amp; Porter relationship attorney with any questions about the new CFIUS website or your company&amp;rsquo;s CFIUS-related matters.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{528A0722-92F2-4926-8ADC-E5E1E45AFB1F}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/division-of-corporation-finance-discontinues-responses-to-no-action-letter-requests</link><a10:author><a10:name>Sara Adler</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/adler-sara</a10:uri><a10:email>sara.adler@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Joel I. Greenberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/greenberg-joel-i</a10:uri><a10:email>joel.greenberg@arnoldporter.com</a10:email></a10:author><title>Division of Corporation Finance Discontinues Responses to No Action Letter Requests Regarding Shareholder Proposals</title><description>Exchange Act Rule 14a-8 addresses when a company must include a shareholder&amp;rsquo;s proposal in its proxy statement for an annual or special meeting of shareholders. In order to have a proposal included, a shareholder must be eligible and follow certain procedures set forth in the rule. Under specific circumstances enumerated in Rule 14a-8, a company is permitted to exclude a shareholder proposal, but only after submitting its reasons to the SEC. On August 14, 2026, the SEC&amp;rsquo;s Division of Corporation Finance (Division) released an updated statement regarding its role in the Rule 14a-8 shareholder proposal process.</description><pubDate>Tue, 18 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;
&lt;p&gt;Exchange Act Rule 14a-8 addresses when a company must include a shareholder&amp;rsquo;s proposal in its proxy statement for an annual or special meeting of shareholders. In order to have a proposal included, a shareholder must be eligible and follow certain procedures set forth in the rule. Under specific circumstances enumerated in Rule 14a-8, a company is permitted to exclude a shareholder proposal, but only after submitting its reasons to the SEC. On August 14, 2026, the SEC&amp;rsquo;s Division of Corporation Finance (Division) &lt;a rel="noopener noreferrer" href="https://www.sec.gov/newsroom/speeches-statements/corpfin-statement-rule-14a-8-process-081426?utm_medium=email&amp;amp;utm_source=govdelivery" target="_blank"&gt;released&lt;/a&gt; an updated statement regarding its role in the Rule 14a-8 shareholder proposal process.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;As described in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/11/sec-streamlines-process-for-excluding-shareholder-proposals" target="_self"&gt;November 2025 Advisory&lt;/a&gt;, the Division announced that from October 1, 2025 through September 30, 2026, it would neither respond to no-action requests for, nor express views on, companies&amp;rsquo; intended reliance on any basis for exclusion of shareholder proposals under Rule 14a-8, other than no-action requests to exclude a proposal under Rule 14a-8(i)(1).[[N:Rule 14a-8(i)(1) permits exclusion of a proposal that &amp;ldquo;is not a proper subject for action by shareholders under the law of the jurisdiction of the company&amp;rsquo;s organization.&amp;rdquo;]] Companies that intended to exclude a proposal on any basis (whether under Rule 14a-8(i)(1) or otherwise), however, were still required to notify the SEC and proponents no later than 80 calendar days before filing a definitive proxy statement. In its November 2025 announcement, the Division also stated that, if a company (or its counsel) included, as part of such notification, an unqualified representation that the company had a reasonable basis to exclude the proposal based on the provisions of Rule 14a-8(i) other than Rule 14a-8(i)(1), prior published guidance, and/or judicial decisions, the Division would respond with a letter indicating that, based solely on such representation and without evaluating the adequacy of the representation or expressing a view on the basis or bases the company intends to rely on in excluding the proposal, it would not object if the company omitted the proposal from its proxy materials.&lt;/p&gt;
&lt;p&gt;The Division has now determined to discontinue responding to Rule 14a-8 no-action requests entirely, including those submitted under Rule 14a-8(i)(1),[[N:The updated statements notes that the Division did not receive any no-action requests to exclude a proposal under Rule 14a-8(i)(1) during the 2025-2026 proxy season.]] effective immediately. Companies will continue to be required under Rule 14a-8(j) to submit notices to the SEC and the proposing shareholder containing the information required by the rule when they intend to exclude shareholder proposals from their proxy materials,[[N:Companies should submit those notices using the online &lt;a rel="noopener noreferrer" href="https://www.sec.gov/forms/shareholder-proposal#no-back" target="_blank"&gt;Shareholder Proposal Form&lt;/a&gt; (the Division&amp;rsquo;s shareholder proposal email address is no longer functional).]] but the Division will no longer respond with a letter indicating that it will not object if a company omits a proposal from its proxy materials. Companies will thus need to make decisions as to whether shareholder proposals may be excluded under Rule 14a-8(i) without the benefit of any views from the Division.&lt;/p&gt;
&lt;p&gt;The staff of the Division of Investment Management (DM), which is responsible for reviewing Rule 14a-8 requests related to investment companies, will take a substantially similar approach.[[N:Any notices submitted pursuant to Rule 14a-8(j) related to investment companies must be submitted by email to &lt;a rel="noopener noreferrer" href="mailto:IMshareholderproposals@sec.gov" target="_blank"&gt;IMshareholderproposals@sec.gov&lt;/a&gt;.]]&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7C575D8E-A768-4455-9FC6-008AFB408180}</guid><link>https://www.americanbar.org/products/inv/book/458443484/</link><a10:author><a10:name>Matthew Eaves</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/eaves-matthew</a10:uri><a10:email>matthew.eaves@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Cara M. Koss</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/koss-cara-m</a10:uri><a10:email>cara.koss@arnoldporter.com</a10:email></a10:author><title>A Guide to International Estate Planning: Design, Administration, and Compliance, Third Edition</title><pubDate>Mon, 17 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{FDA01DD0-FBF4-4CB1-B629-B76769505C84}</guid><link>https://www.pli.edu/programs/fitting-new-tech-into-the-attorney-client-privilege-and-work-product-protection/468814</link><author>melissa.weberman@arnoldporter.com</author><title>Fitting New Tech Into the Attorney-Client Privilege and Work Product Protection</title><pubDate>Mon, 17 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{E97A908A-F22B-4C18-B132-E88DE5504460}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/the-icos-new-statutory-duty-to-produce-an-ai-code-of-practice</link><author>james.castro-edwards@arnoldporter.com</author><title>The UK ICO’s New Statutory Duty to Produce an AI Code of Practice: What It Means for Businesses That Use AI</title><description>The UK Information Commissioner's Office (ICO) is developing a statutory Code of Practice (the Code) on artificial intelligence and automated decision-making that, once finalized, will shape how organizations develop, procure, and use artificial intelligence (AI) systems involving personal data. While the new regulations do not immediately impose additional obligations, the forthcoming Code &amp;mdash; together with the ICO's draft guidance &amp;mdash; signals heightened regulatory expectations for AI governance, meaningful human oversight, vendor management, and documentation. Businesses across all sectors, including those using third-party AI tools rather than building their own, should begin assessing their AI and automated decision-making practices now to prepare for future compliance and reduce regulatory, litigation, and reputational risks.</description><pubDate>Mon, 17 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;All companies that are subject to the UK GDPR and develop or use artificial intelligence (AI) should begin assessing their AI and automated decision-making use now, in anticipation of the Code of Practice (the Code) that the Information Commissioner&amp;rsquo;s Office (ICO) is required to produce, and should monitor ICO guidance and the Code as it develops to ensure compliance.&lt;/p&gt;
&lt;p style="margin-bottom: 5pt;"&gt;&lt;span&gt;In short: the UK&amp;rsquo;s data protection regulator, the ICO, is preparing a formal Code of Practice on AI and automated decision-making, and expects businesses to act well before it takes effect. This is not only a developer issue; any organization that uses AI or automated tools to make or support decisions about people, including tools bought from a third party, and that is subject to the UK GDPR, including organizations with no UK presence at all, where they offer AI-enabled goods or services to, or monitor the behavior of, individuals in the UK, should start assessing that use now. The legal detail behind this is technical, and is set out below for those who want it, but the practical message is straightforward: businesses that map, assess, and document their AI and automated decision-making use now will be considerably better placed than those that wait.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;On May 12, 2026, the &lt;a rel="noopener noreferrer" href="https://www.legislation.gov.uk/uksi/2026/425/made" target="_blank"&gt;Data Protection Act 2018 (Code of Practice on Artificial Intelligence and Automated Decision-Making) Regulations 2026 (SI 2026/425)&lt;/a&gt; (the Regulations) came into force, requiring the Information Commissioner, under section 124A of the Data Protection Act 2018 (DPA) (as inserted by section 92(2) of the Data (Use and Access) Act 2025 (DUAA)), to prepare a Code of Practice on the processing of personal data in relation to developing and using AI and automated decision-making (ADM), including a mandatory children&amp;rsquo;s data component. The Regulations also modify the independent panel process under section 124B of the DPA (inserted by section 93 DUAA) to exclude national security matters from the panel&amp;rsquo;s remit. For these purposes, &amp;ldquo;automated decision-making&amp;rdquo; is defined by reference to Article 22C(1) of the UK General Data Protection Regulation (UK GDPR) and section 50C(1) of the DPA, both also inserted by the DUAA. As we &lt;a href="https://www.biosliceblog.com/2026/02/uks-data-use-and-access-act-what-life-sciences-companies-need-to-know/" target="_self"&gt;previously reported&lt;/a&gt;, most of the data protection reforms introduced by the DUAA took effect on February 5, 2026. The duty on the Information Commissioner under SI 2026/425 is a separate, later development, and arguably the most significant AI-related instrument the ICO has been given to date.&lt;/p&gt;
&lt;p&gt;The ICO had already opened a consultation on March 31, 2026, on updated draft guidance on ADM and profiling, its first detailed reading of the ADM reforms introduced by the DUAA. That &lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/ico-and-stakeholder-consultations/2026/03/ico-consultation-on-the-draft-guidance-about-automated-decision-making-including-profiling/" target="_blank"&gt;consultation&lt;/a&gt; closed on May 29, 2026, and the ICO has indicated that final guidance will follow this winter, ahead of the statutory Code itself, which is not expected to take effect until 2027. For businesses that build AI models, this is a familiar story. For businesses that simply use AI tools bought or licensed from someone else, it is less well understood and, in our experience, considerably more likely to be overlooked.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;SI 2026/425 does not itself impose new obligations on businesses. It gives effect to the duty on the Information Commissioner, under section 124A DPA, to prepare the Code, and modifies the section 124B independent panel process to exclude national security matters from its remit before the Code is laid before Parliament. Section 50C DPA and Article 22C UK GDPR, both inserted by the DUAA, are referenced only to define &amp;ldquo;automated decision-making&amp;rdquo; for the purposes of the Regulations; they are not themselves the source of the duty. Once finalized, the Code is expected to carry the same statutory weight as the existing Children&amp;rsquo;s Code and Data Sharing Code: courts must take it into account in relevant proceedings, and the ICO must have regard to it in enforcement decisions. That is a materially different order of obligation from non-binding guidance.&lt;/p&gt;
&lt;p&gt;In the meantime, the ICO&amp;rsquo;s draft ADM guidance, though not yet final and not itself the statutory Code, is the clearest available signal of the ICO&amp;rsquo;s thinking, including on what will count as &amp;ldquo;meaningful human involvement&amp;rdquo; in an automated decision (active review before a decision takes effect, not a token sign-off) and on the documentation the ICO will expect organizations to hold.&lt;/p&gt;
&lt;h2&gt;Who Does This Affect?&lt;/h2&gt;
&lt;p&gt;
&lt;p&gt;&lt;span&gt;This is not limited to UK-based companies: it includes organizations with no UK presence at all, where they offer AI-enabled goods or services to, or monitor the behavior of, individuals in the UK.&amp;nbsp;&lt;/span&gt;A common misconception is that AI regulation is primarily a problem for the businesses that build AI models. It is not. The ICO&amp;rsquo;s ADM rules attach to the controller that uses an automated or AI-assisted output to make a decision about an individual, regardless of who built the underlying tool. Buying or licensing a third-party AI system does not transfer that responsibility to the vendor. In practice, this reaches:&lt;/p&gt;
&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Recruitment and HR functions&lt;/strong&gt; using AI-assisted CV screening, candidate ranking, or recruitment platforms&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Financial services and insurance businesses&lt;/strong&gt; using AI or automated systems for credit decisions, pricing, or fraud and risk scoring&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Customer-facing businesses&lt;/strong&gt; using AI chatbots or automated triage tools that affect service outcomes, refunds, or complaint handling&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Life sciences and healthcare organizations&lt;/strong&gt; using AI to prioritize, triage, or flag patient cases&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Any business&lt;/strong&gt; procuring third-party AI tools in the ordinary course of vendor and supplier assessment&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The ICO&amp;rsquo;s own research, published in its &lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/what-we-do/recruitment-rewired/" target="_blank"&gt;Recruitment Rewired report&lt;/a&gt; alongside its draft ADM guidance, found that many employers relying on automated recruitment tools were likely conducting solely automated decision-making, without meaningful human involvement and without adequately telling candidates so, in circumstances where several were not aware, or did not acknowledge, that this was what they were doing. The obligation can therefore apply even where a business regards itself as simply using a tool, rather than deploying AI.&lt;/p&gt;
&lt;h2&gt;The Risks of Non-Compliance&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Regulatory enforcement&lt;/strong&gt;. Enforcement for ADM or AI-related breaches sits within the existing UK GDPR penalty regime, fines of up to the higher of &amp;pound;17.5 million or 4% of global annual turnover. Once finalized, the Code is likely to become the benchmark the ICO uses to assess what &amp;ldquo;good practice&amp;rdquo; looks like.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Individual rights and litigation risk&lt;/strong&gt;. Individuals affected by an automated decision have rights to be informed, to obtain meaningful human review, and to challenge the outcome. Unmanaged AI or ADM use is accordingly a direct source of individual complaints, and potentially litigation.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Priority-sector scrutiny&lt;/strong&gt;. The ICO&amp;rsquo;s AI and biometrics strategy names three priority areas: &lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/our-information/our-strategies-and-plans/artificial-intelligence-and-biometrics-strategy/where-we-will-focus/" target="_blank"&gt;foundation model development, ADM in recruitment and public services, and police use of facial recognition technology&lt;/a&gt;, meaning these areas are more likely to attract proactive regulatory attention rather than only complaint-driven investigation. Agentic AI sits outside these three formal priorities for now, but the ICO has flagged it as an emerging area and dedicated guidance is expected as part of its 2026/27 work program. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Vendor and procurement risk&lt;/strong&gt;. AI-specific contractual terms, covering training-data rights, model updates, output ownership, and sub-processing, are increasingly expected in due diligence, but are not yet standard in many existing supplier agreements.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Reputational exposure&lt;/strong&gt;. Unmanaged AI use is increasingly treated as a board-level issue, and being seen to react only after a complaint or investigation is materially worse, from a regulatory and reputational perspective, than being able to demonstrate a documented, proactive governance process.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;What Should Businesses Do Now?&lt;/h2&gt;
&lt;ol&gt;
    &lt;li&gt;Map AI and ADM use across the organization, including tools procured from third-party vendors, not only internally developed systems.&lt;/li&gt;
    &lt;li&gt;Review, or create, Data Protection Impact Assessments where AI or ADM use is likely to result in high risk to individuals, in line with the ICO&amp;rsquo;s draft guidance, with particular attention to the &amp;ldquo;meaningful human involvement&amp;rdquo; test.&lt;/li&gt;
    &lt;li&gt;Audit vendor and procurement contracts for AI-specific terms, including training-data rights, model updates, and output ownership.&lt;/li&gt;
    &lt;li&gt;Benchmark AI use in recruitment, financial decision-making, and any context involving children&amp;rsquo;s data against the ICO&amp;rsquo;s stated priority areas.&lt;/li&gt;
    &lt;li&gt;Monitor for the ICO&amp;rsquo;s final ADM guidance, expected this summer, and the statutory Code itself, expected in 2027, and revisit governance documentation once each is published.&lt;/li&gt;
&lt;/ol&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;SI 2026/425 is, on its face, a narrow procedural instrument: a duty on the Information Commissioner to produce a Code, not a new set of obligations on business. In practice, it is a foundational step toward the most significant AI-specific instrument the ICO will have produced, and the draft ADM guidance already gives a reasonably clear preview of its likely direction. Businesses that treat AI governance as a developer problem, rather than a deployer problem, risk being caught out when the Code and the enforcement expectations that come with it take effect. Those who map, assess, and document their AI and ADM use now will be considerably better placed than those who wait.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{AE5BDDA0-E5F8-4001-AA57-7232F9177833}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/associated-press-quotes-lori-leskin-on-consumer-tariff-refund-litigation</link><title>Associated Press Quotes Lori Leskin on Consumer Tariff Refund Litigation</title><description>Lori Leskin, Co-Chair of Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products practice, was quoted by the &lt;em&gt;Associated Press&lt;/em&gt; article, &amp;ldquo;A surprise credit after an overseas purchase: The tariff refunds now flowing through shippers,&amp;rdquo; which examines the status of refunds following the U.S. Supreme Court's decision earlier this year striking down tariffs imposed under the International Emergency Economic Powers Act, as well as the wave of consumer class actions seeking refunds from retailers who presumably are now receiving the IEEPA refunds.</description><pubDate>Thu, 13 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Lori Leskin, Co-Chair of Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products practice, was quoted by the &lt;em&gt;Associated Press&lt;/em&gt; article, &amp;ldquo;A surprise credit after an overseas purchase: The tariff refunds now flowing through shippers,&amp;rdquo; which examines the status of refunds following the U.S. Supreme Court's decision earlier this year striking down tariffs imposed under the International Emergency Economic Powers Act, as well as the wave of consumer class actions seeking refunds from retailers who presumably are now receiving the IEEPA refunds.&lt;/p&gt;
&lt;p&gt;The article details how shippers and retailers are handling billions of dollars in tariff refunds and the extent to which consumers may ultimately recover amounts they paid directly or indirectly.&lt;/p&gt;
&lt;p&gt;With regard to the majority of the consumer class actions filed against manufacturers and retailers, Lori explained that consumers bringing these cases may face significant challenges proving that higher prices were directly attributable to tariffs. &amp;ldquo;It&amp;rsquo;s going to be very hard for anyone to establish that the price increase they paid was due to tariffs and not some other market force,&amp;rdquo; she said. She added that many of the lawsuits focus broadly on price increases, but &amp;ldquo;to be able to trace a price increase due to a single factor is going to be really difficult given the multifactorial approach that most companies take.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a href="https://apnews.com/article/tariff-refund-shipping-retail-d4162f466eb83aa97e430a86221ad226"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F759E9CD-B684-434F-8165-7D0A5EA25813}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/bti-consulting-group-names-four-arnold-porter-attorneys-2026-bti-client-service-all-stars</link><title>BTI Consulting Group Names Four Arnold &amp; Porter Attorneys 2026 'BTI Client Service All-Stars'</title><description>BTI Consulting Group (BTI) recently named four Arnold &amp;amp; Porter attorneys to its 2026 list of Client Service All-Stars.&amp;nbsp;</description><pubDate>Thu, 13 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;BTI Consulting Group (BTI) recently named four Arnold &amp;amp; Porter attorneys to its 2026 list of Client Service All-Stars. The 25th annual edition of the list is the &amp;ldquo;gold standard&amp;rdquo; for identifying attorneys &amp;ldquo;delivering the best of the best client service.&amp;rdquo; The results are based on more than 350 in-depth, independent interviews with top legal decision makers at the world&amp;rsquo;s most demanding clients as part of BTI&amp;rsquo;s ongoing Annual Survey of General Counsel.&lt;/p&gt;
&lt;p&gt;The following Arnold &amp;amp; Porter attorneys were included in BTI&amp;rsquo;s 2026 list:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Joe Farris, Partner, Commercial Litigation and Intellectual Property (San Francisco)&lt;/li&gt;
    &lt;li&gt;John Freedman, Senior Pro Bono Counsel (Washington, D.C.)&lt;/li&gt;
    &lt;li&gt;Leah Motzkin, Associate, Commercial Litigation and White Collar Defense &amp;amp; Investigations (Los Angeles)&lt;/li&gt;
    &lt;li&gt;Soo-Mi Rhee, Partner, White Collar Defense &amp;amp; Investigations and Anti-Corruption (Washington, D.C.)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Partner Joe Farris is a trial attorney and trusted advisor to technology companies facing high-stakes litigation, with a focus on the novel legal questions reshaping the technology industry.&lt;/p&gt;
&lt;p&gt;Senior Pro Bono Counsel John Freedman devotes his practice to litigating significant civil rights matters in trial and appellate courts.&lt;/p&gt;
&lt;p&gt;Associate Leah Motzkin focuses her practice on complex commercial litigation and White Collar Defense &amp;amp; Investigations.&lt;/p&gt;
&lt;p&gt;Partner Soo-Mi Rhee, who leads the firm&amp;rsquo;s Anti-Corruption practice, offers extensive experience in major anti-corruption, compliance, national security, export controls, and sanctions issues, with particular expertise in high-tech industries.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{92A198FC-03E7-4BD4-B32C-0B0C62BF010F}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/fda-proposes-mandatory-gras-notification-requirement</link><a10:author><a10:name>Howard Sklamberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sklamberg-howard</a10:uri><a10:email>howard.sklamberg@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Raqiyyah Pippins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pippins-raqiyyah</a10:uri><a10:email>raqiyyah.pippins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brandon W. Neuschafer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/neuschafer-brandon-w</a10:uri><a10:email>brandon.neuschafer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ada Ohanenye</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/ohanenye-ada</a10:uri><a10:email>ada.ohanenye@arnoldporter.com</a10:email></a10:author><title>FDA Proposes Mandatory GRAS Notification Requirement</title><description>On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would convert the currently voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement. If finalized, any person who introduces a substance into interstate commerce based on self-determined GRAS status would be required to notify FDA of the GRAS determination and provide supporting documentation. The notification requirement would apply to products currently on the market as well as products introduced in the future.</description><pubDate>Thu, 13 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Introduction&lt;/h2&gt;
&lt;p&gt;On August 11, 2026, the U.S. Food and Drug Administration (FDA) &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2026%2F08%2F11%2F2026-16296%2Fsubstances-generally-recognized-as-safe&amp;amp;data=05%7C02%7CTheresa.Denson%40arnoldporter.com%7C9abc835c519b42ea3a1008def93e2793%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639222242548567888%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=SKI3lVA5YYKRlG2ynSfzEV3Q9A%2BEa0BnTVp3q2cegts%3D&amp;amp;reserved=0" target="_blank"&gt;published a proposed rule&lt;/a&gt; that would convert the currently voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement. If finalized, any person who introduces a substance into interstate commerce based on self-determined GRAS status would be required to notify FDA of the GRAS determination and provide supporting documentation. The notification requirement would apply to products currently on the market as well as products introduced in the future.&lt;/p&gt;
&lt;p&gt;Critically, this is a notification requirement, not a premarket approval requirement. Companies would be able to continue marketing GRAS substances without waiting for any FDA response to a notification. However, as discussed below, the practical implications of this rule are significant and industry participants should carefully evaluate their GRAS portfolios and plans now.&lt;/p&gt;
&lt;p&gt;Comments on the proposed rule are due by December 9, 2026.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;Under the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act), a food additive is deemed &amp;ldquo;unsafe&amp;rdquo; unless it conforms to a regulation prescribing conditions for its safe use or is exempt from the definition of a food additive because it is GRAS.[[N: 21 U.S.C. &amp;sect;&amp;sect; 321(s), 348(a).]] GRAS substances that are generally recognized among qualified experts as having been adequately shown to be safe under the conditions of their intended use have historically occupied a unique regulatory space, given they can be marketed for use in food without prior FDA approval.&lt;/p&gt;
&lt;p&gt;Since 1997, FDA has maintained a voluntary GRAS notification program, which was finalized in 2016. Under this system, a company may independently determine that a substance is GRAS and market it without notifying FDA. If a company chooses to submit a GRAS notice, FDA evaluates the notice and responds with one of three outcomes: (1) by indicating that it does not question the basis for the GRAS conclusion; (2) stating that the notice does not provide a sufficient basis for a GRAS determination; or (3) indicating that the agency granted a request by the notifier to cease its evaluation of the GRAS notice.[[N: U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="https://www.fda.gov/food/generally-recognized-safe-gras/about-gras-notification-program" target="_blank"&gt;About the GRAS Notification Program&lt;/a&gt; (Oct. 2016).]]&lt;/p&gt;
&lt;p&gt;Since 1998, FDA has formally filed over 1,200 GRAS notices.[[N: 91 Fed. Reg. 51834, 51840 (Aug. 11, 2026).]] However, FDA estimates that 1,000 or more additional substances are marketed for use in human food based on independent GRAS conclusions without FDA notifications.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51840.]] This gap has drawn increasing regulatory and public scrutiny. On March 10, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the pathway for firms to introduce purported GRAS substances without notifying FDA. The proposed rule aligns with the administration&amp;rsquo;s &amp;ldquo;Make America Healthy Again&amp;rdquo; initiative and responds to several high-profile incidents that highlighted the risks of the current voluntary system.&lt;/p&gt;
&lt;p&gt;For example, in 2022, tara flour &amp;mdash; a food ingredient marketed under a self-determined GRAS conclusion &amp;mdash; was associated with approximately 400 adverse event reports, yet FDA had never received a GRAS notice for the substance.[[N: 91 Fed. Reg. 51834, 51841 (Aug. 11, 2026); see also U.S. Food and Drug Administration, &lt;a rel="noopener noreferrer" href="https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=Postmarket&amp;amp;id=taraflour&amp;amp;sort=%20Sortterm_ID&amp;amp;order=ASC&amp;amp;startrow=1&amp;amp;type=basic&amp;amp;search=tara%20flour" target="_blank"&gt;Post-Market Determinations That the Use of a Substance Is Not GRAS: Tara Flour&lt;/a&gt; (Apr. 10, 2024).]] Similarly, FDA took enforcement action against caffeinated alcoholic beverages that were alleged to be GRAS.[[N: U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="https://www.fda.gov/food/food-additives-petitions/caffeinated-alcoholic-beverages" target="_blank"&gt;Caffeinated Alcoholic Beverages&lt;/a&gt; (Nov. 17, 2010).]] Further, FDA has taken enforcement action against delta-8 THC-containing food products, stating that the agency was unaware of a basis to conclude that delta-8 THC is GRAS for use in conventional foods.[[N: U.S. Food &amp;amp; Drug Admin., FDA, &lt;a rel="noopener noreferrer" href="https://www.fda.gov/news-events/press-announcements/fda-ftc-continue-joint-effort-protect-consumers-against-companies-illegally-selling-copycat-delta-8" target="_blank"&gt;FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products&lt;/a&gt; (July 16, 2024).]]&lt;/p&gt;
&lt;h2&gt;Summary of the Proposed Rule&amp;rsquo;s Major Provisions&lt;/h2&gt;
&lt;h3&gt;1. Mandatory GRAS Notification&lt;/h3&gt;
&lt;p&gt;Under proposed &amp;sect; 170.205(a), any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&amp;amp;C Act must notify FDA of the basis for the GRAS conclusion.[[N: 91 Fed. Reg. 51834, 51876 (Aug. 11, 2026).]] The requirement applies to substances in both conventional food (human food ingredients) and food contact substances (e.g., food packaging materials). &lt;/p&gt;
&lt;p&gt;The notification requirement would be considered satisfied upon FDA&amp;rsquo;s filing of the submission, not upon mere submission.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51877.]] FDA would have 45 days to determine whether to file a submitted notice.[[N: &lt;em&gt;Id.&lt;/em&gt;]] However, this filing determination is limited to completeness. FDA&amp;rsquo;s substantive evaluation of the GRAS conclusion would occur afterward and could result in a &amp;ldquo;no questions&amp;rdquo; letter, an insufficient-basis letter, or a &amp;ldquo;cease to evaluate&amp;rdquo; letter.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51837.]] None of these outcomes is a formal premarket approval or denial, and the proposed rule would not require a company to await FDA&amp;rsquo;s substantive response before marketing a substance under a GRAS conclusion.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51851.]] Because filed notices and FDA response letters would generally be publicly available, however, companies may face greater practical exposure following an adverse FDA response. A submission that FDA does not file would not satisfy the notification requirement. Further, FDA has proposed to consider noncompliance with that requirement when prioritizing substances for post-market review.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51851.]]&lt;/p&gt;
&lt;h3&gt;2. Exceptions From Mandatory Notification&lt;/h3&gt;
&lt;p&gt;Proposed &amp;sect; 170.205(b) would provide exceptions from the mandatory notification requirement for:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;Substances already covered by an existing &amp;ldquo;no questions&amp;rdquo; letter from FDA&lt;/li&gt;
    &lt;li&gt;Substances listed or affirmed as GRAS in 21 CFR Parts 182, 184, or 186&lt;/li&gt;
    &lt;li&gt;Substances considered GRAS under &amp;sect; 170.30(d) (natural biological origin, widely consumed before 1958) or &amp;sect; 170.30(i)(1)&lt;/li&gt;
    &lt;li&gt;Substances considered through an established FDA process (e.g., Voluntary Premarket Consultations, Animal Cell Culture Consultations) where no need for a GRAS notice was identified&lt;/li&gt;
    &lt;li&gt;Substances subject to a Threshold of Regulation (TOR) exemption under &amp;sect; 170.39&lt;/li&gt;
    &lt;li&gt;Substances covered by an effective Food Contact Notification (FCN), limited to the manufacturer/supplier listed in the FCN&lt;/li&gt;
    &lt;li&gt;Substances for which a streamlined submission has been included on FDA&amp;rsquo;s public list (a time-limited transitional option, discussed below)&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;Notably, while the GRAS mandatory notification requirement bears some resemblance to the process for new dietary ingredients intended for use in dietary supplements, the two frameworks differ in important ways, and companies should not assume that a favorable GRAS conclusion for conventional food also resolves NDIN status for the same substance used in a dietary supplement, or vice versa. The two pathways have distinct statutory triggers and procedural requirements, and each use must be evaluated on its own terms.&lt;/p&gt;
&lt;h3&gt;3. Time-Limited Streamlined Submission Option&lt;/h3&gt;
&lt;p&gt;Recognizing that many substances are already marketed under self-determined GRAS conclusions, the proposed rule includes a time-limited streamlined submission option in proposed Subpart F, &amp;sect; 170.305. This option would create an exception from the GRAS notice submission requirement if certain information about the conditions of use of the substance is submitted to FDA and the submission is included on a public list maintained by FDA, unless FDA issues a determination that a GRAS notice or a food additive petition must be submitted for the intended use of a substance.&lt;/p&gt;
&lt;p&gt;This transitional pathway would apply only to substances already in interstate commerce before the effective date of the final rule, and submissions must be made within one year after that effective date.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51856.]] The information required for submission must include (1) the submitter&amp;rsquo;s name and address; (2) the substance name; (3) intended conditions of use; (4) evidence that the substance was in interstate commerce before the effective date; and (5) if applicable, where FDA sent a cease to evaluate letter in response to a notifier&amp;rsquo;s previous GRAS notice (GRN or AGRN), provide that file number (GRN No. or AGRN No.) as part of the submission.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51869.]]&lt;/p&gt;
&lt;p&gt;The streamlined option is not available for substances that have received an &amp;ldquo;insufficient basis&amp;rdquo; letter or a &amp;ldquo;not GRAS&amp;rdquo; determination from FDA.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51880.]] FDA will post qualifying submissions on a public list, but may subsequently ask questions or determine that a full GRAS notice or food additive petition is required.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51880-51881.]]&lt;/p&gt;
&lt;p&gt;The proposed notification requirement applies to &amp;ldquo;any person introducing a substance into interstate commerce&amp;rdquo; under the GRAS provision.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51876.]] The preamble further explains that &amp;ldquo;[a]ny person could rely&amp;rdquo; on inclusion of a streamlined submission on FDA&amp;rsquo;s public list &amp;ldquo;for the same conditions of use&amp;rdquo; of a substance.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51855.]] Thus, a downstream food manufacturer may be able to rely on a qualifying streamlined submission where it covers the same substance and conditions of use; the proposal does not require each manufacturer using that substance to submit separately. Similarly, an existing &amp;ldquo;no questions&amp;rdquo; letter may excuse a new GRAS notice if it covers the substance under the same conditions of use.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51876.]] Companies should nevertheless confirm that their ingredient is materially the same as the ingredient covered by the submission or letter. FDA cautions that differences in identity, manufacturing process, specifications, or conditions of use may mean that an earlier GRAS conclusion does not apply, in which case a separate GRAS analysis and potentially a new notice may be necessary.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51851.]]&lt;/p&gt;
&lt;p&gt;Although the proposal does not prescribe which supply-chain participant must make a submission, it is likely that ingredient manufacturers or suppliers will often be best positioned to prepare and maintain the underlying GRAS support. Downstream food manufacturers, however, should not assume that a supplier&amp;rsquo;s submission automatically covers their products. They should confirm that any applicable streamlined submission or &amp;ldquo;no questions&amp;rdquo; letter covers the ingredient as manufactured and the relevant conditions of use in their finished foods. Companies may also wish to address these issues in supplier diligence and contractual arrangements, including responsibility for maintaining GRAS support and providing notice of any material changes to the ingredient, its manufacturing process, or its intended uses.
&lt;/p&gt;
&lt;h3&gt;4. Electronic Submission and English Translation Requirements&lt;/h3&gt;
&lt;p&gt;The proposed rule would require that all GRAS notices be submitted electronically through FDA&amp;rsquo;s Collaboration, Submission, and Messaging (COSM) system.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51876.]] A waiver process would be available for filers unable to submit electronically.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51849.]] Additionally, all foreign language materials included in a submission would need to be accompanied by an English translation.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51879.]]&lt;/p&gt;
&lt;h3&gt;5. Revised FDA Review Timelines&lt;/h3&gt;
&lt;p&gt;Under the proposed rule, upon receipt of a submission, FDA will conduct an initial evaluation to determine whether to file it as a GRAS notice and will inform the submitter of the filing decision within two business days.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51877.]] Once filed, FDA will respond to the submitter within 180 days of filing based on its evaluation of the notice, with the possibility of up to two 90-day extensions (increased from one extension under the current program).[[N: &lt;em&gt;Id.&lt;/em&gt;]] FDA will inform a notifier in writing of this second extension as soon as practicable, but no later than the end of the initial 90-day extension.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51854.]]&lt;/p&gt;
&lt;h3&gt;6. Expansion of Threshold of Regulation (TOR) Exemption&lt;/h3&gt;
&lt;p&gt;The proposed rule would expand the TOR exemption program to include substances used in food generally, not just food contact articles.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51846.]] Thus, if a food-contact or processing substance already qualifies for a TOR exemption (i.e., where dietary migration is less than 0.5 ppb and poses negligible health risk), a company does not need to submit a separate mandatory GRAS notice for that use.&lt;/p&gt;
&lt;h3&gt;7. FOIA and Confidentiality Clarifications&lt;/h3&gt;
&lt;p&gt;The proposed rule clarifies that data and information not identified by the submitter as exempt from disclosure under the Freedom of Information Act will be considered non-exempt from public disclosure.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51876.]] Submitters should carefully designate confidential commercial information at the time of submission.&lt;/p&gt;
&lt;h3&gt;8. Animal Food Provisions&lt;/h3&gt;
&lt;p&gt;The proposed rule further includes parallel provisions in Part 570 for animal food, mirroring the Part 170 requirements for human food with appropriate modifications.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51862.]] Notably, the animal food provisions include an exception for ingredients listed by the Association of American Feed Control Officials.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51866.]]&lt;/p&gt;
&lt;h2&gt;Key Timelines and Compliance Dates&lt;/h2&gt;
&lt;p&gt;If the rule is finalized as proposed, the following timeline would apply:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Comment Period&lt;/strong&gt;: 120 days, currently ending December 9, 2026&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Effective Date&lt;/strong&gt;: 60 days after publication of the final rule&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Compliance Date for Mandatory Notification&lt;/strong&gt;: 18 months after the effective date&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Streamlined Submission Window&lt;/strong&gt;: One year from the effective date&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;FDA estimates the present value of costs associated with the proposed rule at approximately $89.6 million with a lower bound of $34.9 million ad an upper bound of $210.0 million, discounted at a 3% discount rate over 10 years, with annualized costs of approximately $10.5 million.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51836.]] The agency acknowledges that the rule may have a significant economic impact on small entities.[[N: &lt;em&gt;Id.&lt;/em&gt; at 51867.]]&lt;/p&gt;
&lt;h2&gt;Key Takeaways&lt;/h2&gt;
&lt;p&gt;FDA&amp;rsquo;s proposal would change the current food ingredient regulatory landscape by converting the current voluntary GRAS notice process into a mandatory notification framework for covered human and animal food uses. Although the proposal is not an FDA premarket approval requirement and does not require a company to await FDA&amp;rsquo;s substantive evaluation before marketing, it would substantially expand FDA&amp;rsquo;s visibility into self-determined GRAS uses, and likely result in greater public scrutiny of the use of GRAS ingredients more generally.&lt;/p&gt;
&lt;p&gt;Because companies may market a substance immediately after filing, without waiting for FDA&amp;rsquo;s substantive review, there is an identifiable risk in going to market before FDA weighs in. If FDA later issues an insufficient basis letter or a not-GRAS determination, the company will already be in the marketplace when that adverse finding becomes public, unlike today&amp;rsquo;s voluntary regime, where declining to submit avoids creating any public record at all. A post-market adverse determination can trigger immediate scrutiny from customers, retailers, and supply-chain partners already relying on the product, and heightens exposure to enforcement. Companies should weigh the benefit of early market entry against the cost of unwinding distribution or responding to customers after an adverse public determination.&lt;/p&gt;
&lt;p&gt;Beyond the risk of adverse action while already on the market, the notification requirement itself increases what becomes visible to FDA and the public. A submitted GRAS notice would give FDA (and potentially the public) access to the company&amp;rsquo;s safety rationale and supporting information, and the proposal states that failure to meet the notification requirement may be considered in FDA&amp;rsquo;s prioritization of substances for post-market review. Accordingly, companies should ensure that each GRAS conclusion is supported by a thorough, scientifically sound, and well-documented analysis &amp;mdash; including with respect to the &lt;em&gt;general recognition&lt;/em&gt; of the ingredient&amp;rsquo;s safety by experts, before relying on the GRAS pathway.&lt;/p&gt;
&lt;p&gt;In anticipation of a final rule, companies may wish to consider the following:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Inventory and classify GRAS uses&lt;/strong&gt;. Companies should identify substances currently marketed under self-determined GRAS conclusions, confirm the relevant conditions of use, and determine whether an exception may apply.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Strengthen GRAS dossiers&lt;/strong&gt;. The quality and completeness of the underlying safety assessment will become more consequential. Companies should review existing files for the scientific evidence, expert analyses, and generally available information needed to support a GRAS conclusion.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Plan for legacy substances&lt;/strong&gt;. For eligible substances already in interstate commerce, companies should evaluate whether to use the proposed one-year streamlined-submission pathway or prepare a full GRAS notice. That decision will require consideration of the applicable exception, the available documentation, and potential disclosure implications.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Assess market-timing risk&lt;/strong&gt;. Companies should decide, on a case-by-case basis, whether to market a substance immediately upon filing or to wait for a more favorable indication from FDA, weighing the commercial benefit of early entry against the risk of having to respond to an adverse determination after the product is already in the marketplace.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Address disclosure and supply-chain issues&lt;/strong&gt;. Because GRAS notices and streamlined submissions may become publicly accessible, companies should carefully identify information that may warrant confidential treatment. Companies should also coordinate with suppliers and customers to determine who will assume responsibility for any notification and whether the available supporting documentation is sufficient.&lt;/li&gt;
&lt;/ul&gt;
&lt;p style="text-align: center;"&gt;* * *&lt;/p&gt;
&lt;p&gt;The proposed rule is open for public comment until December 9, 2026. Companies and trade associations should consider submitting comments, particularly regarding the scope of the exceptions, the adequacy of the streamlined submission pathway, and the compliance timeline.&lt;/p&gt;
&lt;p&gt;We will continue to monitor FDA developments relating to the proposed mandatory GRAS-notification rule. If you have any questions about the proposal, please reach out to one of the authors of this Advisory or to your existing Arnold &amp;amp; Porter contacts.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{842AA6E3-9B4C-427F-BB15-2815E1FA9572}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/will-exxon-mobil-v-cimex-lead-to-more-helms-burton-act-claims</link><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>R. Reeves Anderson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/anderson-r-reeves</a10:uri><a10:email>reeves.anderson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jack Hoover</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hoover-jack</a10:uri><a10:email>jack.hoover@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Rohini Kurup</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kurup-rohini</a10:uri><a10:email>rohini.kurup@arnoldporter.com</a10:email></a10:author><title>Will Exxon Mobil v. CIMEX Lead to More Helms-Burton Act Claims Against Cuban State-Owned Entities?</title><description>On June 23, 2026, in a 6-3 decision in &lt;em&gt;Exxon Mobil Corp. v. Corporaci&amp;oacute;n CIMEX, S.A.&lt;/em&gt;, the Supreme Court held that the Helms-Burton Act (the Act) abrogates the foreign sovereign immunity of Cuban agencies and instrumentalities. Plaintiffs suing those entities under Title III of the Act &amp;mdash; a 1996 law that gives U.S. nationals a private right of action against anyone who &amp;ldquo;traffics&amp;rdquo; in property the Cuban government confiscated &amp;mdash; need not separately establish an exception to immunity under the Foreign Sovereign Immunities Act (FSIA).</description><pubDate>Thu, 13 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 23, 2026, in a 6-3 decision in &lt;em&gt;Exxon Mobil Corp. v. Corporaci&amp;oacute;n CIMEX, S.A.&lt;/em&gt;, the Supreme Court &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/24-699_f204.pdf" target="_blank"&gt;held&lt;/a&gt; that the Helms-Burton Act (the Act) abrogates the foreign sovereign immunity of Cuban agencies and instrumentalities. Plaintiffs suing those entities under Title III of the Act &amp;mdash; a 1996 law that gives U.S. nationals a private right of action against anyone who &amp;ldquo;traffics&amp;rdquo; in property the Cuban government confiscated &amp;mdash; need not separately establish an exception to immunity under the Foreign Sovereign Immunities Act (FSIA).&lt;/p&gt;
&lt;p&gt;The decision removes a jurisdictional barrier for plaintiffs that had stood in the way of Title III suits against Cuban state-owned entities. Whether it produces a wave of new litigation is less certain. Litigation is expensive, the Cuban government has few assets in the United States, and sovereign immunity remains a barrier to post-judgment execution. Those realities may temper how many of the U.S. nationals holding confiscated-property claims choose to follow Exxon&amp;rsquo;s lead. &lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;The case arises under the Cuban Liberty and Democratic Solidarity Act (LIBERTAD Act), commonly known as the &lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/104th-congress/house-bill/927/text" target="_blank"&gt;Helms-Burton Act&lt;/a&gt;, which Congress passed and President Clinton signed in 1996 to tighten economic pressure on Cuba&amp;rsquo;s communist government. One provision of the statute, &lt;a rel="noopener noreferrer" href="https://www.law.cornell.edu/uscode/text/22/6082" target="_blank"&gt;Title III&lt;/a&gt;, allows U.S. nationals whose property was confiscated by the Cuban government to sue people and entities that &amp;ldquo;traffic&amp;rdquo; in that property. In addition to recovering the value of the confiscated property, plaintiffs may also seek treble damages in some instances. &lt;/p&gt;
&lt;p&gt;For more than two decades, no such suits could proceed. From 1996 to 2019, Presidents Clinton, Bush, Obama, and Trump each exercised the Act&amp;rsquo;s suspension authority to hold Title III in abeyance. That changed in May 2019, when the Trump administration&lt;a href="/-/media/files/perspectives/publications/2019/08/calm-before-the-storm.pdf?sc_lang=en&amp;amp;rev=c1740c0efc68481f937c047fec51259a&amp;amp;hash=75FFD6C7DA49DC0E78E640C17D91CF06"&gt; allowed&lt;/a&gt; Title III to go into effect for the first time, prompting more than 50 lawsuits, most of which have been filed against private, non-Cuban companies alleged to have used the confiscated properties in some way.&lt;/p&gt;
&lt;p&gt;In 2019, Exxon &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/DocketPDF/24/24-699/336043/20241227105128755_Exxon_PETITION%20FOR%20A%20WRIT%20OF%20CERTIORARI.pdf" target="_blank"&gt;sued&lt;/a&gt; two Cuban state-owned enterprises, Corporaci&amp;oacute;n Cimex, S.A. and Uni&amp;oacute;n Cuba-Petr&amp;oacute;leo, under Title III for trafficking in service stations, oil refineries, and other facilities that the Cuban government seized in 1960 from a subsidiary of Exxon&amp;rsquo;s predecessor, Standard Oil. In 1969, the U.S. Foreign Claims Settlement Commission (FCSC) certified the value of the confiscated property at more than $70 million (more than $600 million in today&amp;rsquo;s dollars). With statutory treble damages, Exxon sought more than $1 billion.&lt;/p&gt;
&lt;p&gt;The immunity question was central from the outset. Under the FSIA, foreign states and their instrumentalities are presumptively immune from suit in the United States. To overcome this presumption, a plaintiff must demonstrate that one of the FSIA&amp;rsquo;s &lt;a rel="noopener noreferrer" href="https://www.law.cornell.edu/uscode/text/28/part-IV/chapter-97" target="_blank"&gt;exceptions&lt;/a&gt; applies. Title III does not explicitly waive the FSIA&amp;rsquo;s grant of immunity, but it creates a right of action against any &amp;ldquo;person&amp;rdquo; who traffics in confiscated property, with &amp;ldquo;person&amp;rdquo; &lt;a rel="noopener noreferrer" href="https://www.law.cornell.edu/uscode/text/22/6023#:~:text=or%20their%20equivalents.-,(11)Person,-The%20term%20%E2%80%9C" target="_blank"&gt;defined&lt;/a&gt; in the statute to include &amp;ldquo;any agency or instrumentality of a foreign state.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The Cuban government-owned defendants moved to dismiss on immunity grounds. The U.S. District Court for the District of Columbia &lt;a rel="noopener noreferrer" href="https://caselaw.findlaw.com/court/us-dis-crt-dis-col/2124021.html" target="_blank"&gt;agreed&lt;/a&gt; that Title III does not itself displace the FSIA, and a divided panel of the D.C. Circuit affirmed, holding that Title III &amp;ldquo;harmoniously coexists with the FSIA&amp;rdquo; and that plaintiffs must therefore satisfy an FSIA exception to invoke the jurisdiction of U.S. courts. Judge Randolph dissented, concluding that Title III, standing alone, deprives Cuban defendants of immunity.[[N: The lower courts&amp;rsquo; treatment of whether an FSIA exception was in fact satisfied was left for further proceedings; the D.C. Circuit remanded that issue for additional factfinding.]]&lt;/p&gt;
&lt;h2&gt;The Arguments&lt;/h2&gt;
&lt;p&gt;In the Supreme Court, Exxon &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/DocketPDF/24/24-699/385940/20251128123944417_24-699_Merits%20Brief_to%20e-file.pdf" target="_blank"&gt;argued&lt;/a&gt; that Title III&amp;rsquo;s text reflects clear congressional intent to abrogate the immunity of Cuban instrumentalities, principally through its definition of &amp;ldquo;person&amp;rdquo; to reach any &amp;ldquo;agency or instrumentality of a foreign state.&amp;rdquo; Exxon pointed to additional textual signals as well, including provisions assuming that suits and judgments against the Cuban government would follow, and Congress&amp;rsquo; selective borrowing of the FSIA&amp;rsquo;s service-of-process rules. Requiring plaintiffs also to satisfy an FSIA exception, Exxon contended, would defeat Title III&amp;rsquo;s remedial purpose and block billions of dollars in legitimate claims.&lt;/p&gt;
&lt;p&gt;The Cuban defendants &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/DocketPDF/24/24-699/391287/20260109133437554_24-699%20Respondents%20Brief.pdf" target="_blank"&gt;countered&lt;/a&gt; that the FSIA is the exclusive framework for obtaining jurisdiction over foreign sovereigns in U.S. courts. In their view, Title III contains no clear statement abrogating immunity and there is no &amp;ldquo;irreconcilable conflict&amp;rdquo; between the FSIA and the Helms-Burton Act such that the latter would displace the former. They emphasized that Congress has amended the FSIA repeatedly and always expressly, yet never added a Title III exception, and that an earlier draft of Helms-Burton would have amended the FSIA to abrogate immunity, but Congress dropped that provision before enactment.&lt;/p&gt;
&lt;p&gt;In its &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/DocketPDF/24/24-699/370948/20250827161345705_24-699%20Exxon%20Final.pdf" target="_blank"&gt;amicus brief&lt;/a&gt; supporting Exxon, the Trump administration argued that the D.C. Circuit&amp;rsquo;s decision creates an improper hurdle for Title III plaintiffs holding billions of dollars in potential claims. It warned that requiring an FSIA exception &amp;ldquo;stymies critical foreign-policy interests in promoting accountability for the Cuban government&amp;rsquo;s continuing to benefit from its illegal expropriations&amp;rdquo; and urged the Court to hold that Title III independently abrogates immunity.&lt;/p&gt;
&lt;h2&gt;Ruling&lt;/h2&gt;
&lt;p&gt;Writing for the majority, Justice Kavanaugh reversed the D.C. Circuit and held that the Helms-Burton Act itself abrogates the immunity of Cuban agencies and instrumentalities so that Title III plaintiffs suing those entities need not also satisfy an FSIA exception. In reaching that conclusion, the Court drew on its sovereign immunity precedents, including its most recent sovereign immunity ruling, &lt;em&gt;Department of Agriculture Rural Development Rural Housing Service v. Kirtz&lt;/em&gt;, 601 U. S. 42, 55 (2024), in which it held that a waiver of sovereign immunity (to allow suits against the federal government) must be &amp;ldquo;clearly discernable from the sum total&amp;rdquo; of Congress&amp;rsquo; work. The Court applied that same standard in &lt;em&gt;Exxon&lt;/em&gt; to determine whether Congress had abrogated Cuba&amp;rsquo;s sovereign immunity, pointing to four aspects of the Helms-Burton Act that it viewed as collectively making clear Congress&amp;rsquo; intention to do so.&lt;/p&gt;
&lt;p&gt;First, the text of the Act signals congressional intent to waive immunity. Title III creates a cause of action that expressly applies to foreign agencies and instrumentalities. The Act authorizes suits against any &amp;ldquo;person&amp;rdquo; who traffics in confiscated property, and it defines &amp;ldquo;person&amp;rdquo; to include &amp;ldquo;any agency or instrumentality of a foreign state.&amp;rdquo; The Court reasoned that, under its sovereign-immunity precedents, when Congress creates a cause of action that expressly applies to sovereign entities, that formulation can abrogate immunity even without a separate waiver provision.&lt;/p&gt;
&lt;p&gt;Second, applying the FSIA would, in effect, limit the scope of Title III&amp;rsquo;s cause of action. The only potentially relevant FSIA exceptions &amp;mdash; the commercial activity exception and the expropriation exception &amp;mdash; each require a plaintiff to show commercial activity in the United States or an act with direct effect in the United States. Because Helms-Burton simultaneously codified a comprehensive embargo barring most commercial dealings between Americans and Cuban entities, a Title III plaintiff could have difficulty making such a showing. The Court declined to read Congress as having created a cause of action and then rendered it a nullity.&lt;/p&gt;
&lt;p&gt;Third, the Act&amp;rsquo;s jurisdictional structure confirms that the FSIA does not apply. Helms-Burton provides that Title III suits proceed like any other action under 28 U.S.C. &amp;sect; 1331, the general federal-question statute, whereas FSIA suits proceed under 28 U.S.C. &amp;sect; 1330, which confers jurisdiction over foreign sovereigns only where an immunity exception applies. By grounding jurisdiction in &amp;sect; 1331 rather than &amp;sect; 1330, the Court reasoned, Congress signaled that Helms-Burton suits are not FSIA actions.&lt;/p&gt;
&lt;p&gt;Fourth, the Act gives the president plenary authority to suspend Title III suits based on national-security and foreign-policy assessments &amp;mdash; an arrangement that echoes the pre-FSIA regime, in which the Executive Branch, not the courts, primarily decided questions of sovereign immunity. The Court found it implausible that Congress would restore that Executive Branch-centered framework while simultaneously subjecting these suits to the court-administered FSIA, particularly where the FSIA would bar nearly all of them.&lt;/p&gt;
&lt;p&gt;Justice Kagan dissented, joined by Justices Sotomayor and Jackson. The dissent stressed that a cause of action and an abrogation of immunity are analytically distinct, and that Helms-Burton says nothing about immunity even though it directly amended a different part of the FSIA &amp;mdash; the execution-immunity provisions. That silence, the dissent argued, should counsel against finding abrogation, especially given the &amp;ldquo;stringent&amp;rdquo; clear-statement standard that applies to foreign sovereign immunity. The dissent further contended that Title III&amp;rsquo;s cause of action does ample work without any abrogation, because it reaches the private parties that Congress identified as the statute&amp;rsquo;s primary target, and that plaintiffs suing Cuban instrumentalities can still proceed by satisfying an FSIA exception.&lt;/p&gt;
&lt;h2&gt;Implications&lt;/h2&gt;
&lt;p&gt;&lt;em&gt;A further crack in the FSIA&amp;rsquo;s exclusivity&lt;/em&gt;. &lt;em&gt;Exxon Mobil &lt;/em&gt;is the latest decision qualifying the long-held understanding that the FSIA is the sole path to overcoming foreign sovereign immunity in U.S. courts. The Court took a similar step in &lt;em&gt;&lt;a href="/en/perspectives/advisories/2023/05/prosecution-of-foreign-states-in-us-courts"&gt;T&amp;uuml;rkiye Halk Bankası A.Ş. v. United States&lt;/a&gt;&lt;/em&gt; (2023), holding that the FSIA does not govern criminal prosecutions of foreign sovereigns. And in 2025, the Second Circuit&lt;a href="/en/perspectives/advisories/2025/02/anti-terrorism-act-suits-against-foreign-states"&gt; held&lt;/a&gt; in &lt;em&gt;Schansman v. Sberbank&lt;/em&gt; that foreign sovereigns may be sued for acts of terrorism under the Antiterrorism Act even if the FSIA&amp;rsquo;s terrorism exceptions do not apply, provided another FSIA exception applies. &lt;em&gt;Exxon Mobil&lt;/em&gt; now recognizes an implied statutory abrogation of immunity &lt;em&gt;outside&lt;/em&gt; the FSIA, offering courts a way to interpret stand-alone statutes as stripping immunity without amending the FSIA. In doing so, the Court continues to chip away at sovereign immunity through other, non-FSIA statutory schemes. Litigants and foreign sovereigns should expect plaintiffs to continue to seek ways to create further holes in the FSIA&amp;rsquo;s exclusive determination of exceptions to foreign sovereign immunity.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;An open question for non-Cuba sovereigns&lt;/em&gt;. The Court expressly declined to decide whether Helms-Burton also abrogates the immunity of other sovereigns who may have trafficked in confiscated Cuban property. &lt;/p&gt;
&lt;p&gt;That reservation is significant. As the dissent noted, Title III&amp;rsquo;s cause of action reaches non-Cuban and Cuban instrumentalities alike, so the majority&amp;rsquo;s logic does not obviously stop at Cuba. Third-country state-owned enterprises doing business in Cuba now face real uncertainty about their exposure.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Winning a judgment is not the same as collecting on it&lt;/em&gt;. As Justice Kagan emphasized in her dissent, jurisdictional immunity and execution immunity are separate questions. Even a plaintiff who obtains a Title III judgment against a Cuban instrumentality must still satisfy an FSIA execution-immunity exception to attach sovereign assets in the United States. For that reason,&lt;em&gt; Exxon Mobil&lt;/em&gt; lowers the barrier to entering the courthouse but does not ensure recovery, and plaintiffs will not escape the FSIA completely. The majority suggested, however, that a judgment against Cuba may still hold value, even if a plaintiff cannot immediately collect on that judgment &amp;mdash; future changes in the law may increase the prospects of collection, and the judgments could act as leverage for the United States in its relations with Cuba.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;A win for the administration&amp;rsquo;s Cuba policy&lt;/em&gt;. The decision advances the Trump administration&amp;rsquo;s foreign policy towards Cuba. The administration&amp;rsquo;s aggressive rhetoric towards Cuba has been increasingly frequent and direct in the months preceding the &lt;em&gt;Exxon Mobil &lt;/em&gt;decision, and the expanded number of claims against the Cuban government under the Helms-Burton Act will only serve to advance President Trump&amp;rsquo;s adversarial stance toward the communist nation.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;A new avenue for plaintiffs&lt;/em&gt; &lt;em&gt;&amp;mdash;&lt;/em&gt; &lt;em&gt;with limits&lt;/em&gt;. Though the &lt;em&gt;Exxon Mobil&lt;/em&gt; decision opens the door to more suits against Cuban government agencies and instrumentalities, it remains to be seen how many new plaintiffs will jump at this opportunity. While there are over 5,000 holders of FCSC claims, only a tiny fraction have opted to sue Cuban state-owned entities. Instead, most suits have been against American companies with commercial ties to Cuba. Unlike private entities, Cuba lacks substantial resources with which to pay judgments. And as noted above, even if judgments are obtained, plaintiffs must overcome the continuing immunity of sovereign assets from post-judgment attachment.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;*&amp;nbsp; &amp;nbsp;*&amp;nbsp; &amp;nbsp;*&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter can advise companies on how to navigate these recent developments. We regularly counsel U.S. and foreign companies and foreign sovereigns on foreign sovereign immunities issues. Companies seeking guidance on these issues should contact the authors of this Advisory or their usual Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D3FE3D11-9269-4A9E-B096-88831AAF48C7}</guid><link>https://sganaturalgas.org/event/ai-data-centers-domestic-natural-gas-demand-emerging-contract-risks-3000/</link><a10:author><a10:name>C. Thomas Kruse</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kruse-thomas</a10:uri><a10:email>tom.kruse@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jack Vincent</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vincent-jack</a10:uri><a10:email>jack.vincent@arnoldporter.com</a10:email></a10:author><title>AI Data Centers, Domestic Natural Gas Demand &amp; Emerging Contract Risks</title><pubDate>Thu, 13 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{9D9259A4-96B4-4B58-B5C1-75B6680E2426}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/the-american-lawyer-names-arnold-porter-among-top-10-on-2026-a-list</link><title>The American Lawyer Names Arnold &amp; Porter Among Top 10 on 2026 A-List</title><description>Arnold &amp;amp; Porter has once again been recognized on&lt;em&gt; The American Lawyer&amp;rsquo;s &lt;/em&gt;A-List, earning the distinguished honor of being ranked No. 7 among the top 20 firms. This marks the 17th year the firm has been included on the list since its introduction in 2003. The A-List ranking is based on a combination of factors, both financial and cultural, including financial performance, pro bono commitment, associate satisfaction, racial diversity and gender diversity (the percentage of equity partners who are women).</description><pubDate>Wed, 12 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has once again been recognized on &lt;em&gt;The American Lawyer&amp;rsquo;s&lt;/em&gt; A-List, earning the distinguished honor of being ranked No. 7 among the top 20 firms. This marks the 17th year the firm has been included on the list since its introduction in 2003. The A-List ranking is based on a combination of factors, both financial and cultural, including financial performance, pro bono commitment, associate satisfaction, racial diversity and gender diversity (the percentage of equity partners who are women).&lt;/p&gt;
&lt;p&gt;Michael Daneker, Global Co-Chair of Arnold &amp;amp; Porter, said, &amp;ldquo;We&amp;rsquo;re honored to once again be named to &lt;em&gt;The American Lawyer&amp;rsquo;s&lt;/em&gt; A-List. This recognition reflects both the exceptional work our colleagues do on behalf of our clients and the values-driven culture that has long distinguished Arnold &amp;amp; Porter. We&amp;rsquo;re proud of what we&amp;rsquo;ve accomplished together and remain focused on building on that success through collaboration, innovation, and an enduring commitment to excellent client service.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Ellen Kaye Fleishhacker, Global Co-Chair of Arnold &amp;amp; Porter, added: &amp;ldquo;What makes this recognition particularly meaningful is that it reflects the strength of our firm across so many areas. This achievement is made possible by the exceptional people of Arnold &amp;amp; Porter, whose talent, professionalism, and commitment to excellence continue to distinguish our firm.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;According to &lt;em&gt;The American Lawyer's&lt;/em&gt; report, firms on the A-List successfully balance industry demands with core values. The American Lawyer also recently recognized Arnold &amp;amp; Porter as a leading firm on its 2026 "&lt;a href="https://www.law.com/americanlawyer/pro-bono-report/?kw=The+2026+Pro+Bono+Report&amp;amp;utm_position=3&amp;amp;utm_source=email&amp;amp;utm_medium=enl&amp;amp;utm_campaign=morningupdate&amp;amp;utm_content=20260707&amp;amp;utm_term=tal&amp;amp;oly_enc_id=4468I6071134A2X&amp;amp;user_id=5993fb9e6ce954ed0e8b573e"&gt;Pro Bono Scorecard&lt;/a&gt;" for its national and international pro bono work.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A3B3501E-BD5B-4342-AFCB-72E01B160B38}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/fsias-state-instrumentality-divide</link><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>R. Reeves Anderson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/anderson-r-reeves</a10:uri><a10:email>reeves.anderson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sally Pei</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pei-sally</a10:uri><a10:email>sally.pei@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dana Khabbaz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/khabbaz-dana</a10:uri><a10:email>dana.khabbaz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Hannah M. Beiderwieden</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/beiderwieden-hannah</a10:uri><a10:email>hannah.beiderwieden@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jack Hoover</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hoover-jack</a10:uri><a10:email>jack.hoover@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Aaron Sobel</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sobel-aaron</a10:uri><a10:email>aaron.sobel@arnoldporter.com</a10:email></a10:author><title>Same Flag, Different Rules: The FSIA’s State-Instrumentality Divide</title><description>The Foreign Sovereign Immunities Act (FSIA) broadly protects foreign sovereigns and certain affiliated entities from suit and attachment in U.S. courts, but the precise classification of a defendant &amp;mdash; as the foreign state itself, a political subdivision, or an agency or instrumentality &amp;mdash; can have significant legal consequences. Courts generally treat core governmental bodies such as ministries, embassies, and armed forces as part of the state; regional governments such as provinces and cities as political subdivisions; and legally separate entities such as state-owned enterprises, central banks, museums, universities, and sovereign wealth funds as agencies or instrumentalities, with courts examining factors including an entity&amp;rsquo;s functions, independence, relationship to the state, and direct majority ownership. These distinctions are consequential because classification determines the applicable rules for service of process, substantive immunity, attachment and execution of property, punitive damages, and venue; accordingly, correctly identifying a sovereign entity&amp;rsquo;s status at the outset &amp;mdash; and monitoring changes in ownership or status during litigation &amp;mdash; can be critical to an FSIA case.&amp;nbsp;</description><pubDate>Wed, 12 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The Foreign Sovereign Immunities Act of 1976 (FSIA) shields foreign states from suit in the United States and protects certain sovereign property from seizure by court order. As we explained in our &lt;a href="/en/perspectives/advisories/2021/01/can-you-be-sued-under-fsia"&gt;January 2021 Advisory&lt;/a&gt;, the term &amp;ldquo;foreign state&amp;rdquo; sweeps broadly; it covers not only the foreign sovereign itself but also its &amp;ldquo;political subdivisions&amp;rdquo; and its &amp;ldquo;agencies and instrumentalities.&amp;rdquo; But those different classifications matter. Whether a defendant is the foreign state itself, a political subdivision, or an agency or instrumentality can affect the rules governing service of process, the availability of certain immunity defenses, and the scope of attachment and execution protections.&lt;/p&gt;
&lt;p&gt;Classifying an entity is not always straightforward. Foreign governments operate through an array of nominally distinct entities &amp;mdash; ministries, regulatory bodies, subnational governments, state-owned enterprises, museums, universities, and sovereign wealth funds, to name a few &amp;mdash; and courts do not always agree on where particular entities fall within the FSIA&amp;rsquo;s definitional framework.&lt;/p&gt;
&lt;p&gt;In this Advisory, we explain what kinds of sovereign entities are entitled to immunity, how courts draw those distinctions, and why getting it right can matter from the outset of a case.&lt;/p&gt;
&lt;h2&gt;The Three Categories of FSIA Defendants&lt;/h2&gt;
&lt;p&gt;The FSIA affords foreign states two related but distinct protections: immunity from suit and immunity from attachment and execution against certain property. Although those protections are subject to statutory &lt;a href="/en/perspectives/advisories/2021/01/can-you-be-sued-under-fsia"&gt;exceptions&lt;/a&gt;&amp;nbsp;&amp;mdash; such as the commercial activity exception, the expropriation exception, and the terrorism exception &amp;mdash; they extend only to defendants who qualify as &amp;ldquo;foreign states&amp;rdquo; under the statute. The FSIA itself makes clear that &amp;ldquo;foreign state&amp;rdquo; is a broad term: it covers (1) the foreign state itself, (2) a &amp;ldquo;political subdivision of a foreign state,&amp;rdquo; and (3) &amp;ldquo;an agency or instrumentality of a foreign state.&amp;rdquo;[[N: 28 U.S.C. &amp;sect; 1603(a). To illustrate these categories using the government of Canada: (1) would include Canada, (2) would include British Columbia, and (3) would include the Canada Post Corporation.&amp;nbsp;]]&lt;/p&gt;
&lt;h3&gt;Foreign States&lt;/h3&gt;
&lt;p&gt;Of course, a &amp;ldquo;foreign state&amp;rdquo; includes the state proper &amp;mdash; that is, an entity that has a defined territory and a permanent population, under the control of its own government, and that engages in, or has the capacity to engage in, formal relations with other states.[[N: Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 cmt. a (A.L.I. 2018).&amp;nbsp;]] Beyond the state proper, courts routinely define national governments, embassies, permanent missions, armed forces, and government ministries as part of the &amp;ldquo;foreign state&amp;rdquo; &amp;mdash; because these entities are so closely bound up with the structure of the sovereign that they defy treatment as anything else.[[N: &lt;em&gt;See&lt;/em&gt; Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 cmt. b; &lt;em&gt;id.&lt;/em&gt; &amp;sect; 452 reporters&amp;rsquo; note 3; &lt;em&gt;see also&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Garb v. Republic of Poland&lt;/em&gt;, 440 F.3d 579, 594 (2d Cir. 2006) (Poland&amp;rsquo;s Ministry of Treasury was an &amp;ldquo;integral part of Poland&amp;rsquo;s political structure&amp;rdquo;); &lt;em&gt;Transaero, Inc. v. La Fuerza Aerea Boliviana&lt;/em&gt;, 30 F.3d 148, 153 (D.C. Cir. 1994) (Air Force of Bolivia was a foreign state); &lt;em&gt;S.K. Innovation, Inc. v. Finpol&lt;/em&gt;, 854 F. Supp. 2d 99, 108 (D.D.C. 2012) (Kazakhstan&amp;rsquo;s Agency on Economic Crimes and Corruption was a foreign state).]] Foreign ministries, in particular, are treated as foreign states, because the management of a country&amp;rsquo;s foreign affairs is an indispensable government function.[[N: &lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Roeder v. Islamic Republic of Iran&lt;/em&gt;, 333 F.3d 228, 234 (D.C. Cir. 2003) (holding that the Iranian Ministry of Foreign Affairs warranted classification as part of the state itself).]]&lt;/p&gt;
&lt;p&gt;In unusual circumstances, a political party may qualify as a foreign state. In &lt;em&gt;Missouri v. People&amp;rsquo;s Republic of China&lt;/em&gt; &amp;mdash; a suit seeking damages against the People&amp;rsquo;s Republic of China and various related entities for their role in the COVID-19 pandemic &amp;mdash; the Eighth Circuit held that the Chinese Communist Party was the &amp;ldquo;alter ego&amp;rdquo; of the Chinese state and therefore entitled to immunity as the sovereign itself.[[N: &lt;em&gt;Missouri ex rel. Bailey v. People&amp;rsquo;s Republic of China&lt;/em&gt;, 90 F.4th 930, 934 (8th Cir. 2024).]] Political parties are not ordinarily treated as the state itself,[[N: &lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Tachiona v. United States&lt;/em&gt;, 386 F.3d 205, 222 (2d Cir. 2004) (holding that Zimbabwe&amp;rsquo;s ruling party was a &amp;ldquo;private entity and not an agency or instrumentality of a foreign state&amp;rdquo;).]] but the court reasoned that the Chinese Communist Party, by exercising pervasive control over the Chinese government and all other defendants in the case, effectively constituted the &amp;ldquo;body politic&amp;rdquo; governing China.[[N: &lt;em&gt;Missouri ex rel. Bailey&lt;/em&gt;, 90 F.4th at 935.]]&lt;/p&gt;
&lt;h3&gt;Political Subdivisions of Foreign States&lt;/h3&gt;
&lt;p&gt;Before the passage of the FSIA, courts generally did not consider cities and towns of foreign nations to be immune from suit.[[N: Restatement (Third) of Foreign Relations Law &amp;sect; 452 cmt. b (A.L.I. 1987); &lt;em&gt;id.&lt;/em&gt; &amp;sect; 452 reporters&amp;rsquo; note 1; &lt;em&gt;see also&lt;/em&gt; E.H. Schopler, Annotation, Modern Status of the Rules as to Immunity of Foreign Sovereign from Suit in Federal or State Courts, 25 A.L.R.3d 322, &amp;sect; 6&amp;amp;#91a&amp;amp;#93 (1969) (noting that, though the Second Restatement stated definitively that constituent units of a state were not entitled to immunity, courts disagreed with each other on this issue).]] But the FSIA extended the umbrella of immunity to &amp;ldquo;political subdivisions&amp;rdquo; of a foreign state, which include regional subdivisions of the state, such as cities, districts, cantons, provinces, and territories.[[N: Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 reporters&amp;rsquo; note 2 (collecting cases).]] So, cities like Amsterdam are protected from suit.[[N: &lt;em&gt;Malewicz v. City of Amsterdam&lt;/em&gt;, 362 F. Supp. 2d 298, 306 (D.D.C. 2005); &lt;em&gt;see also Beierwaltes v. L&amp;rsquo;Office Federale De La Culture De La Confederation Suisse&lt;/em&gt;, 999 F.3d 808, 819 (2d Cir. 2021) (Canton of Geneva &amp;ldquo;undisputed&amp;amp;#91ly&amp;amp;#93&amp;rdquo; a political subdivision of Swiss Confederation); &lt;em&gt;Big Sky Network Canada, Ltd. v. Sichuan Provincial Gov&amp;rsquo;t&lt;/em&gt;, 533 F.3d 1183, 1189 (10th Cir. 2008) (Sichuan Province and Qinyang District were political subdivisions of the People&amp;rsquo;s Republic of China); Restatement (Third) of Foreign Relations Law &amp;sect; 452 cmt. b (explaining that, under the FSIA, &amp;ldquo;constituent units of federal unions,&amp;rdquo; including &amp;ldquo;cantons,&amp;rdquo; &amp;ldquo;are entitled to sovereign immunity to the same extent as the federal state itself&amp;rdquo;); Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 reporters&amp;rsquo; note 2 (&amp;ldquo;States and provinces are political subdivisions under the FSIA.&amp;rdquo;).&amp;nbsp;]]&lt;/p&gt;
&lt;p&gt;The line between a foreign state and its political subdivisions, however, is not always clear. Courts sometimes describe &amp;mdash; incorrectly, in our view &amp;mdash; certain ministries or other core components of a national government as political subdivisions rather than as the state itself. The Fourth Circuit, for instance, has held that the Iraqi Ministry of Defense qualifies as a political subdivision of Iraq,[[N: &lt;em&gt;Wye Oak Tech., Inc. v. Republic of Iraq&lt;/em&gt;, 666 F.3d 205, 215 (4th Cir. 2011); &lt;em&gt;see also Garb&lt;/em&gt;, 440 F.3d at 596 n.21 (suggesting that &amp;ldquo;political subdivisions&amp;rdquo; in the FSIA refers to all governmental units beneath the central government, rather than different geographical subdivisions of government).]] while other courts have treated core governmental components &amp;mdash; including foreign ministries, armed forces, intelligence services, and diplomatic missions &amp;mdash; as part of the foreign state itself.[[N: &lt;em&gt;See&lt;/em&gt; Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 cmt. b; &lt;em&gt;id&lt;/em&gt;. &amp;sect; 452 reporters&amp;rsquo; note 3; &lt;em&gt;see also Ben-Rafael v. Islamic Republic of Iran&lt;/em&gt;, 718 F. Supp. 2d 25, 32 (D.D.C. 2010) (holding that the Iranian Revolutionary Guard Corps was a governmental entity and thus the foreign state itself); &lt;em&gt;Gates v. Syrian Arab Republic&lt;/em&gt;, 580 F. Supp. 2d 53, 64 (D.D.C. 2008) (holding that the Syrian military intelligence service was the &amp;ldquo;foreign state itself&amp;rdquo;), aff&amp;rsquo;d, 646 F.3d 1 (D.C. Cir. 2011); &lt;em&gt;Int&amp;rsquo;l Rd. Fed&amp;rsquo;n v. Embassy of the Democratic Republic of the Congo&lt;/em&gt;, 131 F. Supp. 2d 248, 250 (D.D.C. 2001) (holding that an embassy of the Democratic Republic of the Congo was a foreign state); &lt;em&gt;Berdakin v. Consulado de la Republica de El Salvador&lt;/em&gt;, 912 F. Supp. 458, 461 (C.D. Cal. 1995) (holding that a consulate of El Salvador qualified as a foreign state).]] Courts have also held offices within ministries to be political subdivisions &amp;mdash; among them, the Chief Mining Commissioner of Zimbabwe&amp;rsquo;s Ministry of Mines[[N: &lt;em&gt;Amaplat Mauritius Ltd. v. Zimbabwe Mining Dev. Corp.&lt;/em&gt;, 663 F. Supp. 3d 11, 28 (D.D.C. 2023), &lt;em&gt;rev&amp;rsquo;d in part, vacated in part, and remanded with instructions to dismiss for lack of jurisdiction&lt;/em&gt;, 143 F.4th 496 (D.C. Cir. 2025), cert. denied, No. 25-699, 2026 WL 1127199 (U.S. Apr. 27, 2026).]] and the Office of the Minister of Finance of Trinidad[[N: &lt;em&gt;Singh ex rel. Singh v. Caribbean Airlines Ltd.&lt;/em&gt;, 798 F.3d 1355, 1359-60 (11th Cir. 2015); &lt;em&gt;see also Missouri ex rel. Bailey&lt;/em&gt;, 90 F.4th at 935 (holding that China&amp;rsquo;s Ministry of Civil Affairs, Ministry of Emergency Management, and National Health Commission, as well as provincial and township-level bodies, were political subdivisions of China based on their direct connection to the official government).]] &amp;mdash; even though Congress suggested that &amp;ldquo;a department or ministry which acts and is suable in its own name&amp;rdquo; could be an agency or instrumentality rather than a political subdivision.[[N: H.R. Rep. No. 94-1487, at 15 (1976), reprinted in 1976 U.S.C.C.A.N. 6604, 6614.]]&lt;/p&gt;
&lt;p&gt;For practical purposes, though, the distinction between the foreign state itself and its political subdivisions usually does not matter. The FSIA treats foreign states and their political subdivisions identically for purposes of service, immunity, and attachment. The real action is in distinguishing foreign states and subdivisions from agencies and instrumentalities. &lt;/p&gt;
&lt;h3&gt;Agencies and Instrumentalities of Foreign States&lt;/h3&gt;
&lt;p&gt;An &amp;ldquo;agency&amp;rdquo; or &amp;ldquo;instrumentality&amp;rdquo; of a foreign state is an entity that is (1) &amp;ldquo;a separate legal person, corporate or otherwise&amp;rdquo;; (2) &amp;ldquo;an organ of a foreign state or political subdivision thereof, or a majority of whose shares or other ownership interest is owned by a foreign state or political subdivision thereof&amp;rdquo;; and (3) neither a citizen of a U.S. state nor created under the laws of any third country.[[N: 28 U.S.C. &amp;sect; 1603(b).]] The critical feature is legal separateness: unlike ministries or regional governments, agencies and instrumentalities are distinct legal entities, even when closely tied to the sovereign. &lt;/p&gt;
&lt;p&gt;State-owned enterprises &amp;mdash; like national airlines, art galleries, telecommunications companies, railways, petroleum companies, and sovereign wealth funds &amp;mdash; are paradigmatic examples of agencies or instrumentalities.[[N: &lt;em&gt;See Havlish v. Taliban&lt;/em&gt;, 152 F.4th 339, 357 (2d Cir. 2025), &lt;em&gt;reh&amp;rsquo;g en banc denied&lt;/em&gt;, 170 F.4th 100 (2d Cir. 2026) (holding that Da Afghanistan Bank was an agency or instrumentality of the state of Afghanistan); &lt;em&gt;Chey v. Orbitz Worldwide, Inc.&lt;/em&gt;, 983 F. Supp. 2d 1219, 1228 (D. Haw. 2013) (holding that foreign airline, a majority of whose shares were owned by China, was an agency or instrumentality of China); &lt;em&gt;Bayer &amp;amp; Willis Inc. v. Republic of Gambia&lt;/em&gt;, 283 F. Supp. 2d 1, 4 (D.D.C. 2003) (holding that a Gambian telecommunications company 99% owned by The Gambia was an &amp;ldquo;agency or instrumentality&amp;rdquo; of The Gambia); &lt;em&gt;Abrams v. Soci&amp;eacute;t&amp;eacute; Nationale Des Chemins De Fer Fran&amp;ccedil;ais&lt;/em&gt;, 389 F.3d 61, 63 (2d Cir. 2004) (holding that the French national railroad company was an agency or instrumentality); &lt;em&gt;Adler v. Fed. Republic of Nigeria&lt;/em&gt;, 107 F.3d 720, 723 (9th Cir. 1997) (holding that the Nigerian National Petroleum Corporation was an instrumentality of Nigeria); &lt;em&gt;Janvey v. Libyan Inv. Auth.&lt;/em&gt;, 840 F.3d 248, 259 (5th Cir. 2016) (holding that the Libyan Investment Authority, a sovereign wealth fund, was an instrumentality of Libya).]] Central banks have also been treated as agencies or instrumentalities of the sovereign,[[N: &lt;em&gt;Adler&lt;/em&gt;, 107 F.3d at 723 (holding that the Central Bank of Nigeria was an instrumentality of Nigeria); &lt;em&gt;Weininger v. Castro&lt;/em&gt;, 462 F. Supp. 2d 457, 497 (S.D.N.Y. 2006) (holding that the central bank of Cuba was an agency or instrumentality); &lt;em&gt;S &amp;amp; S Mach. Co. v. Masinexportimport&lt;/em&gt;, 706 F.2d 411, 414 (2d Cir. 1983) (holding that &amp;ldquo;&amp;amp;#91&amp;amp;#93tate-owned central banks indisputably are included in the &amp;sect; 1603(b) definition of &amp;lsquo;agency or instrumentality.&amp;rsquo;&amp;rdquo;).]] as have some cultural and educational institutions, including state universities and museums.[[N: &lt;em&gt;Compare de Csepel v. Republic of Hungary&lt;/em&gt;, 169 F. Supp. 3d 143, 167 (D.D.C. 2016) (holding that museums were an agency or instrumentality of Hungary, and observing that defendants already admitted that those museums and a state university were agencies or instrumentalities), &lt;em&gt;aff&amp;rsquo;d in part, appeal dismissed in part, and remanded&lt;/em&gt;, 859 F.3d 1094 (D.C. Cir. 2017), &lt;em&gt;and&lt;/em&gt; &lt;em&gt;Altmann v. Republic of Austria&lt;/em&gt;, 317 F.3d 954, 969 (9th Cir. 2002) (observing that the defendants did not contest that the Austrian Gallery is an agency or instrumentality of Austria), &lt;em&gt;amended on denial of reh&amp;rsquo;g&lt;/em&gt;, 327 F.3d 1246 (9th Cir. 2003), &lt;em&gt;aff&amp;rsquo;d on other grounds&lt;/em&gt;, 541 U.S. 677 (2004), &lt;em&gt;with Berg v. Kingdom of the Netherlands&lt;/em&gt;, 24 F.4th 987, 993-96 (4th Cir. 2022) (concluding that Ministry of Education, Culture &amp;amp; Science of the Netherlands and Cultural Heritage Agency of the Netherlands were not separate legal persons but instead political subdivisions of the Netherlands), &lt;em&gt;and Taylor v. Kingdom of Sweden&lt;/em&gt;, No. 18-cv-1133, 2019 WL 3536599, at *4 (D.D.C. Aug. 2, 2019) (concluding that Sweden&amp;rsquo;s National Museum of World Culture&amp;rsquo;s core functions were &amp;ldquo;intertwined with Sweden&amp;rsquo;s sovereign obligations such that &amp;amp;#91it was&amp;amp;#93 part of the foreign state&amp;rdquo;).]] The Eighth Circuit extended that analysis to the Wuhan Institute of Virology and the Chinese Academy of Sciences, finding both legally separate from the Chinese state and thus agencies or instrumentalities, even though they remained closely connected to it.[[N: &lt;em&gt;Missouri ex rel. Bailey&lt;/em&gt;, 90 F.4th at 935.]]&lt;/p&gt;
&lt;h2&gt;How Courts Decide Whether an Entity Is an Agency or Instrumentality (Rather Than Part of the State Itself)&lt;/h2&gt;
&lt;p&gt;Courts have provided different articulations of the inquiry into whether an entity is an agency or instrumentality, rather than part of the state itself. However framed, the basic question is whether the entity is meaningfully separate from the foreign state itself. In practice, the analysis usually turns on the entity&amp;rsquo;s function, its relationship to the state, and its ownership structure. &lt;/p&gt;
&lt;h3&gt;The Core Functions Test&lt;/h3&gt;
&lt;p&gt;Some courts apply the so-called &amp;ldquo;core functions&amp;rdquo; test to determine whether an entity is sufficiently separate from the foreign state.[[N: Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 reporters&amp;rsquo; notes 4-5; &lt;em&gt;Transaero&lt;/em&gt;, 30 F.3d at 153; Garb, 440 F.3d at 592.]] That test looks to whether the entity&amp;rsquo;s predominant functions are governmental or commercial.[[N:&amp;nbsp;&lt;em&gt;Transaero&lt;/em&gt;, 30 F.3d at 153; &lt;em&gt;Garb&lt;/em&gt;, 440 F.3d at 594.]] If those functions are governmental &amp;mdash; for example, diplomacy, military operations, or foreign affairs &amp;mdash; courts tend to treat the entity as part of the state itself.[[N:&amp;nbsp;&lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Transaero&lt;/em&gt;, 30 F.3d at 153 (holding that the Bolivian Air Force was part of the Bolivian state itself); &lt;em&gt;Roeder&lt;/em&gt;, 333 F.3d at 234 (holding that &amp;ldquo;&amp;amp;#91t&amp;amp;#93he conduct of foreign affairs is an important and &amp;lsquo;indispensable&amp;rsquo; government function,&amp;rdquo; so that the Iranian Ministry of Foreign Affairs was part of Iran itself).]] If the entity&amp;rsquo;s core functions are mainly commercial &amp;mdash; for example, those of a national oil company &amp;mdash; courts are more likely to treat it as a separate agency or instrumentality.[[N:&amp;nbsp;&lt;em&gt;See Transaero&lt;/em&gt;, 30 F.3d at 152; &lt;em&gt;see also Adler&lt;/em&gt;, 107 F.3d at 723.]]&lt;/p&gt;
&lt;p&gt;But that does not mean any entity connected to commercial activity is automatically commercial and not part of the state for FSIA purposes. One court held, for example, that while Zimbabwe&amp;rsquo;s Chief Mining Commissioner&amp;rsquo;s duties &amp;ldquo;unquestionably touch on commercial activity,&amp;rdquo; the commissioner&amp;rsquo;s role in connection with that activity was &amp;ldquo;as a government regulator and adjudicator&amp;rdquo; &amp;mdash; &amp;ldquo;not as a market participant&amp;rdquo; &amp;mdash; and the commissioner thus remained part of the state.[[N:&amp;nbsp;&lt;em&gt;Amaplat&lt;/em&gt;, 663 F. Supp. 3d at 28.]] By contrast, the same court found in a different case that a state-owned museum&amp;rsquo;s functions were &amp;ldquo;largely commercial,&amp;rdquo; and so classified that entity as an agency or instrumentality.[[N:&amp;nbsp;&lt;em&gt;de Csepel&lt;/em&gt;, 169 F. Supp. 3d at 167.]]&lt;/p&gt;
&lt;h3&gt;The Organ Inquiry&lt;/h3&gt;
&lt;p&gt;Other courts proceed more directly from Section 1603(b)&amp;rsquo;s statutory categories by asking whether an entity qualifies as an &amp;ldquo;organ&amp;rdquo; of the state or is majority-owned by one. Because the FSIA does not define &amp;ldquo;organ,&amp;rdquo; courts have developed different multi-factor tests.[[N: Restatement (Fourth) of Foreign Relations Law &amp;sect; 452 reporters&amp;rsquo; note 5; &lt;em&gt;see Kelly v. Syria Shell Petroleum Dev. B.V.&lt;/em&gt;, 213 F.3d 841, 846 (5th Cir. 2000).]] The most widely applied framework examines:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(1) whether the foreign state created the entity for a national purpose; (2) whether the foreign state actively supervises the entity; (3) whether the foreign state requires the hiring of public employees and pays their salaries; (4) whether the entity holds exclusive rights to some right in the [foreign] country; and (5) how the entity is treated under foreign state law.[[N:&amp;nbsp;&lt;em&gt;Kelly&lt;/em&gt;, 213 F.3d at 846-47 (quoting &lt;em&gt;Supra Med. Corp. v. McGonigle&lt;/em&gt;, 955 F. Supp. 374, 379 (E.D. Pa. 1997)); &lt;em&gt;accord Filler v. Hanvit Bank&lt;/em&gt;, 378 F.3d 213, 217 (2d Cir. 2004). Other circuits have devised tests that include and expand upon the same five factors. &lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;EIE Guam Corp. v. Long Term Credit Bank of Japan, Ltd.&lt;/em&gt;, 322 F.3d 635, 640 (9th Cir. 2003) (employing similar test that includes an additional sixth factor, &amp;ldquo;the level of government financial support&amp;rdquo;); &lt;em&gt;USX Corp. v. Adriatic Ins. Co.&lt;/em&gt;, 345 F.3d 190, 209 (3d Cir. 2003) (employing the same test as the Ninth Circuit, with the addition of a seventh factor, &amp;ldquo;the ownership structure of the entity&amp;rdquo;).]]&lt;/p&gt;
&lt;p&gt;These factors are not applied mechanically, nor must they all be met for an entity to qualify as an organ.[[N:&amp;nbsp;&lt;em&gt;See Kelly&lt;/em&gt;, 213 F.3d at 847; &lt;em&gt;Murphy v. Korea Asset Mgmt. Corp.&lt;/em&gt;, 421 F. Supp. 2d 627, 645 (S.D.N.Y. 2005), &lt;em&gt;aff&amp;rsquo;d&lt;/em&gt;, 190 F. App&amp;rsquo;x 43 (2d Cir. 2006).]] After all, most entities of this type will likely share characteristics of both governmental and non-governmental bodies.[[N:&amp;nbsp;&lt;em&gt;See Murphy&lt;/em&gt;, 421 F. Supp. 2d at 641.]] At bottom, though, the key consideration is &amp;ldquo;the entity&amp;rsquo;s ability to act independently.&amp;rdquo;[[N:&amp;nbsp;&lt;em&gt;Gates v. Victor Fine Foods&lt;/em&gt;, 54 F.3d 1457, 1461 (9th Cir. 1995); &lt;em&gt;see Havlish&lt;/em&gt;, 152 F.4th at 357 (implying that Da Afghanistan Bank would not satisfy the organ prong because &amp;ldquo;the Afghanistan banking law vests &amp;amp;#91it&amp;amp;#93 with substantial autonomy&amp;rdquo;).]]&lt;/p&gt;
&lt;h3&gt;Majority Ownership&lt;/h3&gt;
&lt;p&gt;The final way an entity can be classified as an agency or instrumentality of a foreign state is if the state or political subdivision thereof directly owns a majority stake in that entity.[[N:&amp;nbsp;&lt;em&gt;Dole Food Co. v. Patrickson&lt;/em&gt;, 538 U.S. 468, 477 (2003); &lt;em&gt;see&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Havlish&lt;/em&gt;, 152 F.4th at 357 (holding that Da Afghanistan Bank satisfied the majority-ownership prong because it was &amp;ldquo;100% owned by Afghanistan&amp;rdquo;).]]&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Direct Ownership&lt;/em&gt;. The entity must be more than 50% directly owned by the state to qualify for immunity. The Supreme Court has held that indirect ownership, where the entity is &amp;ldquo;separated from the [state] by one or more intermediate corporate tiers,&amp;rdquo; is insufficient.[[N:&amp;nbsp;&lt;em&gt;Dole Food&lt;/em&gt;, 538 U.S. at 473.]] Applying the majority-ownership test, one court has held that the Korean government&amp;rsquo;s ownership of up to 70% of the Korea Asset Management Corporation was unavailing because its direct ownership stake was only 42.8% &amp;mdash; insufficient to satisfy the majority test.[[N:&amp;nbsp;&lt;em&gt;Murphy&lt;/em&gt;, 421 F. Supp. 2d at 640 &amp;amp; n.12, 645.]] Therefore, the entity could qualify as an agency or instrumentality only if it were also an organ of Korea.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Timing of Ownership&lt;/em&gt;. The Supreme Court has held that FSIA instrumentality status is ordinarily assessed &amp;ldquo;at the time suit is filed,&amp;rdquo; not at the time of the alleged wrong.[[N:&amp;nbsp;&lt;em&gt;Dole Food&lt;/em&gt;, 538 U.S. at 478-80 (holding that chemical companies were not entitled to instrumentality status because &amp;ldquo;&amp;amp;#91a&amp;amp;#93ny relationship recognized under the FSIA between &amp;amp;#91them&amp;amp;#93 and Israel had been severed before suit was commenced&amp;rdquo;).]] Thus, a French railroad company could invoke the FSIA even though it had been privately owned during World War II (when the claims arose), because France wholly owned that entity when the suit was filed.[[N:&amp;nbsp;&lt;em&gt;Abrams&lt;/em&gt;, 389 F.3d at 64-65.]] In the Second Circuit, however, FSIA immunity may also attach &amp;ldquo;mid-suit&amp;rdquo; if a foreign state acquires majority ownership after the complaint is filed.[[N:&amp;nbsp;&lt;em&gt;Bartlett v. Baasiri&lt;/em&gt;, 81 F.4th 28, 33 (2d Cir. 2023); &lt;em&gt;see Schansman v. Sberbank of Russia PJSC&lt;/em&gt;, 128 F.4th 70, 80 (2d Cir. 2025), &lt;em&gt;cert. denied&lt;/em&gt;, 146 S. Ct. 117 (2025) (holding that Russian bank qualified as an agency or instrumentality under the FSIA after the Russian Ministry of Finance acquired a majority ownership interest post-filing).]] The practical implication is that sovereign status must be monitored throughout the life of the case, particularly where sanctions, nationalizations, restructurings, or other events alter a sovereign&amp;rsquo;s ownership stake after suit is filed.&lt;/p&gt;
&lt;h2&gt;What the FSIA Does Not Cover&lt;/h2&gt;
&lt;p&gt;Prior to 2010, several courts of appeals had applied the FSIA&amp;rsquo;s protections to foreign &lt;em&gt;officials&lt;/em&gt;, in addition to foreign government entities. The Supreme Court clarified in &lt;em&gt;Samantar v. Yousuf&lt;/em&gt; that foreign officials are not &amp;ldquo;foreign states&amp;rdquo; within the meaning of the act. Their immunity, if any, is governed instead by common law.[[N:&amp;nbsp;&lt;em&gt;Samantar v. Yousuf&lt;/em&gt;, 560 U.S. 305 (2010).]]&lt;/p&gt;
&lt;p&gt;Nor does the FSIA govern diplomatic or consular immunity.[[N:&amp;nbsp;&lt;em&gt;Id.&lt;/em&gt; at 319 n.12.]] Those immunities are instead governed by separate treaty-and-statute frameworks, including the Vienna Convention on Diplomatic Relations, the Diplomatic Relations Act, and the Vienna Convention on Consular Relations.[[N: Vienna Convention on Diplomatic Relations art. 31, Apr. 18, 1961, 23 U.S.T. 3227, 500 U.N.T.S. 95; Vienna Convention on Consular Relations art. 43, Apr. 24, 1963, 21 U.S.T. 77, 596 U.N.T.S. 261; Diplomatic Relations Act, Pub. L. No. 95-393, 92 Stat. 808 (1978).]]&lt;/p&gt;
&lt;h2&gt;Distinctions With a Difference&lt;/h2&gt;
&lt;p&gt;An entity&amp;rsquo;s classification as a foreign state or political subdivision on the one hand, or as an agency or instrumentality on the other, is not mere semantics. It determines how the entity must be served and can even control the substantive immunity protections to which it is entitled under the FSIA.&lt;/p&gt;
&lt;h3&gt;Service of Process&lt;/h3&gt;
&lt;p&gt;Classifications matter from the outset of a case. Service on a foreign state or political subdivision is governed by Section 1608(a),[[N: 28 U.S.C. &amp;sect; 1608(a); &lt;em&gt;see Gibbons v. Republic of Ireland&lt;/em&gt;, 532 F. Supp. 668, 671 (D.D.C. 1982).]] which imposes an inflexible, hierarchical sequence of service methods: plaintiffs must first attempt service under any applicable international convention on service of judicial documents (or any special arrangement between the plaintiff and the state); if that fails, the clerk of court must dispatch the summons and complaint and a notice of suit (with translations) addressed to the head of the relevant ministry of foreign affairs; and if that also fails, the clerk may transmit documents through the U.S. Secretary of State via diplomatic channels.[[N:&amp;nbsp;&lt;em&gt;See&lt;/em&gt; 28 U.S.C. &amp;sect; 1608(a)(1)-(4); &lt;em&gt;Republic of Sudan v. Harrison&lt;/em&gt;, 587 U.S. 1, 4-5 (2019) (explaining that &amp;sect; 1608(a) sets out &amp;ldquo;in hierarchical order&amp;rdquo; the methods for serving a foreign state or political subdivision).]] The service provisions for states and political subdivisions must be &amp;ldquo;strict[ly]&amp;rdquo; followed.[[N:&amp;nbsp;&lt;em&gt;Harrison&lt;/em&gt;, 587 U.S. at 19.]]&lt;/p&gt;
&lt;p&gt;By contrast, service on an agency or instrumentality is governed by Section 1608(b).[[N: 28 U.S.C. &amp;sect; 1608(b).]] Although Section 1608(b) must also be closely followed, it is more flexible, resembles rules applicable to corporate defendants,[[N: Restatement (Fourth) of Foreign Relations Law &amp;sect; 461 cmt. a.]] and allows for a broader range of service methods &amp;mdash; including delivery to an authorized agent in the United States or certain other methods reasonably calculated to give actual notice.[[N:&amp;nbsp;&lt;em&gt;Howe v. Embassy of Italy&lt;/em&gt;, 68 F. Supp. 3d 26, 32 (D.D.C. 2014) (quoting 28 U.S.C. &amp;sect; 1608(b)(3)).]]&lt;/p&gt;
&lt;p&gt;Cases can &amp;mdash; and do &amp;mdash; fail because of improper service under the FSIA.[[N:&amp;nbsp;&lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;em&gt;Harrison&lt;/em&gt;, 587 U.S. at 4, 19 (reversing where the service packet was mailed to the foreign state&amp;rsquo;s embassy rather than to the foreign minister&amp;rsquo;s office in the foreign state); &lt;em&gt;Saint-Gobain Performance Plastics Europe v. Bolivarian Republic of Venezuela&lt;/em&gt;, 23 F.4th 1036 (D.C. Cir. 2022) (finding service under &amp;sect; 1608(a)(2) and the Hague Convention defective because Venezuelan law requires service on Attorney General, who was never served); &lt;em&gt;Magness v. Russian Fed&amp;rsquo;n&lt;/em&gt;, 247 F.3d 609, 611-13 (5th Cir. 2001) (finding service defective where plaintiff &amp;ldquo;sen&amp;amp;#91t&amp;amp;#93 the summons and complaint directly to the Russian Deputy Minister of Culture&amp;rdquo; rather than &amp;ldquo;asking the clerk of the district court to send the summons and notice of suit&amp;rdquo;); &lt;em&gt;Transaero&lt;/em&gt;, 30 F.3d at 153-54 (vacating default judgment where plaintiff did not &amp;ldquo;strict&amp;amp;#91ly&amp;amp;#93 adhere&amp;amp;#91 &amp;amp;#93 to the terms of &amp;sect; 1608(a)&amp;rdquo; in serving Bolivian Air Force, and &amp;ldquo;actual notice&amp;rdquo; of suit could not cure defective service); &lt;em&gt;Adetoro v. King Abdullah Acad.&lt;/em&gt;, No. 1:19-cv-01918, 2019 WL 3457989, at *3 (D.D.C. July 30, 2019) (finding service &amp;ldquo;not strictly compliant&amp;rdquo; and therefore invalid where plaintiffs &amp;ldquo;themselves mailed the documents rather than the clerk of the court&amp;rdquo;).]] A plaintiff that serves the wrong type of defendant under the wrong provision may face a motion to dismiss for insufficient service of process or be forced to start the time-consuming service process anew.&lt;/p&gt;
&lt;h3&gt;Substantive Immunity Protections&lt;/h3&gt;
&lt;p&gt;Classifications also matter when plaintiffs invoke FSIA exceptions to immunity, as agencies and instrumentalities are subject to a slightly different set of immunity protections than foreign states and their political subdivisions. The so-called expropriation exception in Section 1605(a)(3) is a leading example. As we explained in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2021/01/can-you-be-sued-under-fsia" target="_self"&gt;January 2021 Advisory&lt;/a&gt;, this provision strips certain foreign state entities of sovereign immunity when property is taken in violation of international law so long as that property has the requisite connection to the United States. For claims against the foreign state itself, a plaintiff generally must show that the expropriated property &amp;mdash; or any property exchanged for it &amp;mdash; is &amp;ldquo;present in the United States in connection with [that state&amp;rsquo;s] commercial activity carried on in the United States.&amp;rdquo;[[N: 28 U.S.C. &amp;sect; 1605(a)(3).]] For claims against an agency or instrumentality, the requirement is more relaxed: it is enough that the property be &amp;ldquo;owned or operated&amp;rdquo; by an agency or instrumentality that is engaged in commercial activity in the United States, regardless of whether that property is, in fact, used in connection with any U.S. commercial activity.[[N: 28 U.S.C. &amp;sect; 1605(a)(3).]] The property itself need not be present in the United States. That asymmetry incentivizes some sovereign defendants to argue that they are the foreign state itself, rather than an agency or instrumentality, to invoke the more demanding standard of Section 1605(a)(3)&amp;rsquo;s first clause.[[N: For example, in &lt;em&gt;Holtzman v. Kunstmuseen Krefeld&lt;/em&gt;, a German municipal art museum moved to dismiss on the ground that it was part of the foreign state itself and thus immune from suit because the disputed paintings were not present in the United States. 805 F. Supp. 3d 368, 376 (D.D.C. 2025). The court rejected that argument, holding that the museum&amp;rsquo;s core functions &amp;mdash; exhibition, acquisition, and collection management &amp;mdash; were commercial rather than governmental, and that the museum was therefore an agency or instrumentality subject to suit. &lt;em&gt;Id.&lt;/em&gt; at 376-77.]] Conversely, some plaintiffs have sought to extend the more permissive second clause to the foreign state itself. The D.C. Circuit has repeatedly rejected that argument,[[N:&amp;nbsp;&lt;em&gt;Agudas Chasidei Chabad of U.S. v. Russian Fed&amp;rsquo;n&lt;/em&gt;, 110 F.4th 242, 250 (D.C. Cir. 2024), &lt;em&gt;cert. denied&lt;/em&gt;, No. 24-909, 2026 WL 135737 (U.S. Jan. 20, 2026); &lt;em&gt;Philipp v. Fed. Republic of Germany&lt;/em&gt;, 894 F.3d 406, 414 (D.C. Cir. 2018), &lt;em&gt;vacated on other grounds and remanded&lt;/em&gt;, 592 U.S. 169 (2021); &lt;em&gt;Schubarth v. Fed. Republic of Germany&lt;/em&gt;, 891 F.3d 392, 401 (D.C. Cir. 2018); &lt;em&gt;de Csepel v. Republic of Hungary&lt;/em&gt;, 859 F.3d 1094, 1107-08 (D.C. Cir. 2017).]] but the Ninth Circuit&amp;rsquo;s position is less clear: it has upheld jurisdiction over foreign states even though only the second clause was met &amp;mdash; though each time without providing any reasoning.[[N:&amp;nbsp;&lt;em&gt;Altmann&lt;/em&gt;, 317 F.3d at 968-69; &lt;em&gt;Cassirer v. Kingdom of Spain&lt;/em&gt;, 616 F.3d 1019, 1022, 1028-34 (9th Cir. 2010) (en banc); &lt;em&gt;Sukyas v. Romania&lt;/em&gt;, 765 F. App&amp;rsquo;x 179, 180 (9th Cir. 2019). In &lt;em&gt;Cassirer&lt;/em&gt;, the Ninth Circuit affirmed jurisdiction over Spain and its instrumentality based on the instrumentality&amp;rsquo;s ownership of the expropriated property and its commercial activity in the United States, but without engaging in independent analysis of jurisdiction over Spain. 616 F.3d at 1028-34. Later, however, the United States explained that the parties and the court had erroneously assumed that jurisdiction over the instrumentality also supplied jurisdiction over Spain under Section 1605(a)(3)&amp;rsquo;s second clause, and the plaintiffs then voluntarily dismissed Spain. &lt;em&gt;See&lt;/em&gt; Brief for the United States as Amicus Curiae at 15-16, &lt;em&gt;Kingdom of Spain v. Estate of Cassirer&lt;/em&gt;, No. 10-786, 2011 WL 2135028 (U.S. May 27, 2011); &lt;em&gt;Cassirer v. Thyssen-Bornemisza Collection Found.&lt;/em&gt;, 737 F.3d 613, 617 (9th Cir. 2013).]]&lt;/p&gt;
&lt;h3&gt;Immunity From Attachment&lt;/h3&gt;
&lt;p&gt;Even if a plaintiff establishes jurisdiction and obtains a judgment, the FSIA separately shields sovereign property from attachment and execution absent a statutory exception.[[N: 28 U.S.C. &amp;sect; 1610(a); Restatement (Fourth) of Foreign Relations Law &amp;sect; 464 cmt. a.]] Here too, classifications matter. For property of a foreign state or political subdivision, creditors ordinarily must show that the specific property at issue is or was used for commercial activity in the United States.[[N: 28 U.S.C. &amp;sect; 1610(a)(2).]] For property of an agency or instrumentality, additional statutory exceptions apply, and the standard is generally less demanding: a creditor need only show that the agency or instrumentality itself is generally engaged in commercial activity in the United States &amp;mdash; not that the property sought to be attached is used for that purpose.[[N: 28 U.S.C. &amp;sect; 1610(b). In cases brought under the FSIA&amp;rsquo;s terrorism exception, however, the ordinary distinction between state property and agency property matters less. That is because Congress has authorized attachment of certain property of a foreign state&amp;rsquo;s agencies or instrumentalities to satisfy a terrorism judgment against the state. &lt;em&gt;Id.&lt;/em&gt; &amp;sect; 1610(g)(1). That said, Section 1610(g) does not provide a freestanding basis for attachment and execution. &lt;em&gt;See Rubin v. Islamic Republic of Iran&lt;/em&gt;, 583 U.S. 202, 218-19 (2018). Instead, a judgment holder must still identify an applicable immunity exception elsewhere in Section 1610. &lt;em&gt;See id.&lt;/em&gt; at 212-13.]]&lt;/p&gt;
&lt;h3&gt;Damages and Venue&lt;/h3&gt;
&lt;p&gt;Agencies and instrumentalities can be held liable for punitive damages,[[N: 28 U.S.C. &amp;sect; 1606.]] whereas foreign states and their political subdivisions generally cannot &amp;mdash; except in limited cases defined by statute, such as certain terrorism claims.[[N: 28 U.S.C. &amp;sect;&amp;sect; 1605A(c), 1606.]] Some venue provisions differ for agencies and instrumentalities and for states: the FSIA subjects agencies and instrumentalities to suit wherever they are licensed to do business or are doing business, while foreign states and political subdivisions can always be sued in the District of Columbia.[[N: 28 U.S.C. &amp;sect; 1391(f)(1), (3)-(4).]]&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;Whether a defendant is the foreign state itself, a political subdivision, or an agency or instrumentality is not always easy to determine. Courts have reached different conclusions about regulators, cultural institutions, and other affiliated entities, and judges do not always agree on the applicable tests. But the classification matters; a defendant&amp;rsquo;s status triggers different rules for service, immunity, attachment, venue, and damages.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has represented foreign state clients &amp;mdash; from every continent except Antarctica &amp;mdash; in FSIA proceedings across the United States. Please contact us if you have questions about how any of these issues may arise in a particular matter.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8932012A-5C9B-4BCE-BE3B-0F460B98A17A}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/chambers-again-recognizes-arnold-porter-as-a-leading-crisis-management-firm</link><title>Chambers Again Recognizes Arnold &amp; Porter as a Leading Crisis Management Firm</title><description>The 2026 edition of &lt;em&gt;Chambers Crisis and Risk Management&lt;/em&gt; named Arnold &amp;amp; Porter as a top firm in this critical space. The guide ranks the leading crisis response and risk advisory professional services providers in key markets worldwide, featuring detailed coverage of core crisis and risk services across the United States, United Kingdom, and global markets based on independent research and evaluations conducted annually by &lt;em&gt;Chambers&lt;/em&gt;. According to &lt;em&gt;Chambers&lt;/em&gt;, Arnold &amp;amp; Porter &amp;ldquo;has an outstanding team of attorneys that they can deploy to address urgent matters.</description><pubDate>Tue, 11 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 2026 edition of &lt;em&gt;Chambers Crisis and Risk Management&lt;/em&gt; named Arnold &amp;amp; Porter as a top firm in this critical space. The guide ranks the leading crisis response and risk advisory professional services providers in key markets worldwide, featuring detailed coverage of core crisis and risk services across the United States, United Kingdom, and global markets based on independent research and evaluations conducted annually by &lt;em&gt;Chambers&lt;/em&gt;. According to &lt;em&gt;Chambers&lt;/em&gt;, Arnold &amp;amp; Porter &amp;ldquo;has an outstanding team of attorneys that they can deploy to address urgent matters.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter brings the broad experience to effectively manage the wide range of potential repercussions that an organization can face: criminal investigations, whether federal, state, or overseas; bet-the-company securities, product liability, or class-action litigation; congressional or regulatory investigations; and relentless media scrutiny. The firm has the depth and breadth to assemble the right team, the skills to devise an overarching strategy and defense, and the insights to give practical advice for every significant legal, reputational, and operational issue that arises, no matter the nature or scope of the crisis.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D524A09C-D062-4BB5-B735-70D24651DDD8}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/njbiz-names-paul-fishman-to-2026-law-power-list</link><title>NJBIZ Names Paul Fishman to 2026 Law Power List</title><description>Arnold &amp;amp; Porter partner Paul Fishman has been named to &lt;em&gt;NJBIZ&lt;/em&gt;'s 2026 Law Power list. The annual list recognizes New Jersey legal professionals whose leadership, professional accomplishments, and public service are helping shape the state's legal community and business landscape.</description><pubDate>Tue, 11 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Paul Fishman has been named to &lt;em&gt;NJBIZ&lt;/em&gt;'s 2026 Law Power list. The annual list recognizes New Jersey legal professionals whose leadership, professional accomplishments, and public service are helping shape the state's legal community and business landscape.&lt;/p&gt;
&lt;p&gt;Paul, who heads the firm's Crisis Management and Strategic Response team, was recognized for his distinguished legal career and leadership in both public and private practice. In his profile, Paul reflected on his tenure as U.S. attorney for the District of New Jersey, describing the opportunity to lead a team committed to exercising its authority with integrity as his proudest professional achievement.&lt;em&gt; NJBIZ&lt;/em&gt; also highlighted Paul&amp;rsquo;s perspective on the legal profession and his advice to the next generation of lawyers: to view practicing law as a privilege and use their skills to make a meaningful difference for clients and society.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{244EF1B0-AC06-45D9-9D26-AE5A5C5FE25A}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/stacey-halliday-speaks-to-corporate-counsel-on-california-recyclability-law</link><title>Stacey Halliday Speaks to Corporate Counsel  on California Recyclability Law and Sustainability Compliance</title><description>&lt;p&gt;Arnold &amp;amp; Porter Environmental partner Stacey Halliday was quoted in the &lt;em&gt;Corporate Counsel&lt;/em&gt; article, &amp;ldquo;Ruling Blocking California Law Shows Headwinds for State Sustainability Measures,&amp;rdquo; which examines the federal court ruling temporarily blocking enforcement of a California law that would sharply restrict companies' ability to label packaging as recyclable and the broader implications for corporate sustainability compliance.&lt;/p&gt;</description><pubDate>Mon, 10 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Environmental partner Stacey Halliday was quoted in the &lt;em&gt;Corporate Counsel&lt;/em&gt; article, &amp;ldquo;Ruling Blocking California Law Shows Headwinds for State Sustainability Measures,&amp;rdquo; which examines the federal court ruling temporarily blocking enforcement of a California law that would sharply restrict companies' ability to label packaging as recyclable and the broader implications for corporate sustainability compliance.&lt;/p&gt;
&lt;p&gt;While the preliminary injunction provides companies with temporary relief from the law's requirements, Stacey cautioned that businesses should continue preparing for compliance because the law remains on the books and the injunction's duration is uncertain. "I think we're still in a holding pattern," she said. "I would not change compliance plans. I would proceed into that uncertainty assuming that compliance will be mandatory, understanding that there may be options down the line."&lt;/p&gt;
&lt;p&gt;Stacey also noted that even if California's current law is ultimately struck down, companies should expect continued efforts to regulate recyclability claims. Restrictions could emerge through revised state legislation or at the federal level, where proposals have sought to bring greater consistency to the growing patchwork of state requirements.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law.com/corpcounsel/2026/08/06/ruling-blocking-california-law-shows-headwinds-for-state-sustainability-measures/"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9527D5BB-0284-4C39-BF9B-F0C75B3B3D15}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/latin-lawyer-recognizes-arnold-porter-mergers-acquisitions-lawyers-in-2025-deal-tracker</link><title>Latin Lawyer Recognizes Arnold &amp; Porter Mergers &amp; Acquisitions Lawyers in 2025 Deal Tracker</title><description>Arnold &amp;amp; Porter partners Carlos Lobo and Marina Richter, senior associates Kristen Acosta and Claire Frost, and associate Jacob Saracino have been recognized in &lt;em&gt;Latin Lawyer&lt;/em&gt;'s 2025 Deal Tracker, an annual ranking of the most active international lawyers advising on transactions across Latin America.</description><pubDate>Mon, 10 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partners Carlos Lobo and Marina Richter, senior associates Kristen Acosta and Claire Frost, and associate Jacob Saracino have been recognized in &lt;em&gt;Latin Lawyer&lt;/em&gt;'s 2025 Deal Tracker, an annual ranking of the most active international lawyers advising on transactions across Latin America.&lt;/p&gt;
&lt;p&gt;The following Arnold &amp;amp; Porter lawyers were recognized among the most active international lawyers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Carlos Lobo&amp;mdash;Mergers &amp;amp; Acquisitions&lt;/li&gt;
    &lt;li&gt;Marina Richter&amp;mdash;Mergers &amp;amp; Acquisitions&lt;/li&gt;
    &lt;li&gt;Kristen Acosta&amp;mdash;Mergers &amp;amp; Acquisitions&lt;/li&gt;
    &lt;li&gt;Claire Frost&amp;mdash;Mergers &amp;amp; Acquisitions&lt;/li&gt;
    &lt;li&gt;Jacob Saracino&amp;mdash;Mergers &amp;amp; Acquisitions&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These recognitions underscore Arnold &amp;amp; Porter's broad mergers and acquisitions capabilities in Latin America. The firm advises strategic and private equity clients on complex domestic, cross-border, and international mergers and acquisitions, business combinations, and joint venture transactions, drawing on integrated capabilities across tax, antitrust, benefits, litigation, and other complementary practices to help clients achieve their transaction objectives.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{DD7196F7-3685-4751-AA02-23B6471BA957}</guid><link>https://www.fdli.org/2026/08/upf-litigation-update-plaintiffs-causation-challenge-comes-into-sharper-focus/</link><a10:author><a10:name>Jocelyn A. Wiesner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wiesner-jocelyn-a</a10:uri><a10:email>jocelyn.wiesner@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anand Agneshwar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/agneshwar-anand</a10:uri><a10:email>anand.agneshwar@arnoldporter.com</a10:email></a10:author><title>UPF Litigation Update: Plaintiffs’ Causation Challenge Comes into Sharper Focus</title><pubDate>Mon, 10 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{6E8FEBB7-D51B-4081-93BF-E9CBF81717F7}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/capital-snapshot-august-2026</link><a10:author><a10:name>Eugenia E. Pierson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pierson-eugenia-e</a10:uri><a10:email>Eugenia.Pierson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Allison Jarus</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jarus-allison</a10:uri><a10:email>allison.jarus@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter E. Duyshart</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/duyshart-peter</a10:uri><a10:email>peter.duyshart@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Crawford</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/crawford-emily</a10:uri><a10:email>emily.crawford@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Mahaffy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mahaffy-emily</a10:uri><a10:email>emily.mahaffy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dylan L. Kelemen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kelemen-dylan-l</a10:uri><a10:email>dylan.kelemen@arnoldporter.com</a10:email></a10:author><title>Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions</title><description>&lt;span style="color: #494949; background-color: #fefefe;"&gt;Our Legislative &amp;amp; Public Policy team is pleased to provide the August 2026 edition of &lt;/span&gt;&lt;em style="color: #494949; background-color: #fefefe; margin: 0px; padding: 0px; border: 0px; line-height: inherit;"&gt;Capital Snapshot&lt;/em&gt;&lt;span style="color: #494949; background-color: #fefefe;"&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the &lt;/span&gt;&lt;em style="color: #494949; background-color: #fefefe; margin: 0px; padding: 0px; border: 0px; line-height: inherit;"&gt;Capital Snapshot&lt;/em&gt;&lt;span style="color: #494949; background-color: #fefefe;"&gt; contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, and recently-announced retirements, resignations, vacancies, and candidacies. We also share updates pertaining to the FY 2027 federal funding and the appropriations processes, including the recently passed Senate continuing resolution. Our team also provides comprehensive updates on the latest on trade and tariffs.&lt;/span&gt;</description><pubDate>Mon, 10 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Our Legislative &amp;amp; Public Policy team is pleased to provide the August 2026 edition of &lt;em&gt;Capital Snapshot&lt;/em&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the &lt;em&gt;Capital Snapshot&lt;/em&gt; contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, and recently-announced retirements, resignations, vacancies, and candidacies. We also share updates pertaining to the FY 2027 federal funding and the appropriations processes, including the recently passed Senate continuing resolution. Our team also provides comprehensive updates on the latest on trade and tariffs. Furthermore, we share some salient legislative and policy updates across a variety of additional key policy areas, including: (1) defense; (2) tax; (3) financial services; (4) artificial intelligence; (5) technology; (6) data privacy; (7) health care; (8) education; and (9) energy and environment. Additionally, we provide an overview and outlook of the upcoming 2026 midterm elections in November, as well as an update to the latest primaries across the country. Our team also takes a look at current public opinion polling on President Trump&amp;rsquo;s job performance and policy priorities, and assesses economic factors and conditions that could impact the future political landscape in an election year.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{97C5F2A9-D4AD-4BDD-B2BC-0A0509BC8BFC}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/india-business-law-journal-recognizes-arnold-porter-in-2026-foreign-law-firm-report</link><title>India Business Law Journal Recognizes Arnold &amp; Porter in 2026 Foreign Law Firm Report</title><description>&lt;p&gt;Arnold &amp;amp; Porter has been recognized by &lt;em&gt;India Business Law Journal,&lt;/em&gt; in the "Significant Players" category as part of the publication&amp;rsquo;s 2026 Foreign Law Firm Report. The report highlighted Arnold &amp;amp; Porter for its work on &amp;ldquo;cutting-edge AI,&amp;rdquo; and team members were commended for having &amp;ldquo;an instinctive understanding of the deep connections that determine how decision-making in India truly works.&amp;rdquo; It recognizes the work done by Arnold &amp;amp; Porter advising Indian companies across a variety of industries.&lt;/p&gt;</description><pubDate>Fri, 07 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has been recognized by &lt;em&gt;India Business Law Journal,&lt;/em&gt; in the "Significant Players" category as part of the publication&amp;rsquo;s 2026 Foreign Law Firm Report. The report highlighted Arnold &amp;amp; Porter for its work on &amp;ldquo;cutting-edge AI,&amp;rdquo; and team members were commended for having &amp;ldquo;an instinctive understanding of the deep connections that determine how decision-making in India truly works.&amp;rdquo; It recognizes the work done by Arnold &amp;amp; Porter advising Indian companies across a variety of industries.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;India Business Law Journal&lt;/em&gt; noted Arnold &amp;amp; Porter&amp;rsquo;s continued investment in its India practice and its multidisciplinary team, which advises clients on complex cross-border transactions, disputes, investigations, regulatory matters, and intellectual property issues. &lt;/p&gt;
&lt;p&gt;The Foreign Law Firm report is based on research covering more than 600 law firms worldwide that handled India-related matters over the past year. According to the &lt;em&gt;India Business Law Journal&lt;/em&gt;, firms were evaluated through submissions, editorial research, public records, news reports, and feedback from in-house counsel and Indian law firms.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{11E81445-64F9-4606-9166-405F1CAF5A06}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/federal-court-permanently-enjoins-prop-65-cancer-warnings-for-dea-in-cosmetics</link><a10:author><a10:name>Dania Qahoush</a10:name><a10:uri>https://www.arnoldporter.com/en/people/q/qahoush-dania</a10:uri><a10:email>dania.qahoush@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Angel Tang Nakamura</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nakamura-angel-tang</a10:uri><a10:email>angel.nakamura@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Zachary Fayne</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fayne-zachary</a10:uri><a10:email>zachary.fayne@arnoldporter.com</a10:email></a10:author><title>Federal Court Permanently Enjoins Prop 65 Cancer Warnings for DEA in Cosmetics</title><description>&lt;p&gt;A recent federal court decision permanently bars the California Attorney General from enforcing Proposition 65&amp;rsquo;s cancer warning requirement for diethanolamine in cosmetics and personal care products, marking the fourth successful First Amendment challenge to a Proposition 65 warning based on disputed scientific evidence. The ruling reinforces a growing judicial trend limiting compelled warnings where the underlying science remains contested and provides industry groups with an increasingly established roadmap for challenging similar Proposition 65 requirements, while signaling continued scrutiny of warning obligations based solely on International Agency for Research on Cancer classifications.&lt;/p&gt;</description><pubDate>Fri, 07 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;A federal court in the Eastern District of California has permanently barred the California Attorney General from enforcing Proposition 65&amp;rsquo;s cancer warning requirement for diethanolamine (DEA) in cosmetics and personal care products. The order, entered June 23, 2026, in &lt;em&gt;The Personal Care Products Council v. Bonta&lt;/em&gt;, is the fourth time in recent years that a federal court has enjoined a requirement to provide Proposition 65 warnings on First Amendment grounds, following earlier victories involving glyphosate, acrylamide, and titanium dioxide. Industry groups now have a fairly consistent playbook for attacking Proposition 65 warnings based on disputed science, and the state&amp;rsquo;s Attorney General is increasingly declining to defend against such challenges.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;Proposition 65 requires businesses to warn before knowingly exposing anyone in California to a chemical the state has listed as &amp;ldquo;known to the state to cause cancer or reproductive toxicity.&amp;rdquo; Cal. Health &amp;amp; Safety Code &amp;sect; 25249.6. Under the so-called &amp;ldquo;Labor Code mechanism,&amp;rdquo; if the International Agency for Research on Cancer (IARC) classifies a chemical as a known human carcinogen, or a probable or possible human carcinogen with &amp;ldquo;sufficient evidence&amp;rdquo; of carcinogenicity in animals, California&amp;rsquo;s Office of Environmental Health Hazard Assessment (OEHHA) must automatically add it to the Proposition 65 list, without any independent scientific review. Penalties for noncompliance can reach $2,500 per violation, per day. Proposition 65 also allows private citizens &amp;ldquo;acting in the public interest&amp;rdquo; to file lawsuits to enforce the warning requirement, so long as they first serve a 60-day notice of violation on the business, the Attorney General, and local prosecutors. If none of those officials elects to file a suit in that window, the private plaintiff can step into the shoes of the state and proceed on the state&amp;rsquo;s behalf. Private plaintiffs have strong incentives to pursue such claims because they are entitled to keep a share of the penalties ultimately recovered. Indeed, a substantial majority of Proposition 65 suits are brought by private citizens rather than the Attorney General.&lt;/p&gt;
&lt;p&gt;DEA is an organic compound used as a surfactant, emulsifier, and pH adjuster in a wide range of consumer products, including shampoos, conditioners, hair gels and dyes, shaving gels, makeup, lotions, and sunscreens. It was added to the Proposition 65 list in June 2012 after IARC concluded that DEA was &amp;ldquo;possibly carcinogenic to humans.&amp;rdquo; Notably, neither OEHHA nor any federal or California state agency has ever independently concluded that DEA is linked to cancer in humans.&lt;/p&gt;
&lt;h2&gt;The PCPC Lawsuit Challenging DEA&amp;rsquo;s Inclusion in Prop 65 List&lt;/h2&gt;
&lt;p&gt;The Personal Care Products Council (PCPC), the trade association for cosmetics and personal care product manufacturers, sued Attorney General Rob Bonta in March 2026 under 42 U.S.C. &amp;sect; 1983, arguing that a Proposition 65 warning regarding DEA was based on only a single study that found a possible cancer link in a strain of mice known to be particularly prone to cancer. PCPC argued that this warning requirement forces its members to make false and misleading statements about their DEA-containing products.&lt;/p&gt;
&lt;p&gt;The PCPC case follows a similar legal theory to the glyphosate case (&lt;em&gt;National Association of Wheat Growers v. Bonta&lt;/em&gt;), the acrylamide case (&lt;em&gt;California Chamber of Commerce v. Bonta&lt;/em&gt;), and PCPC&amp;rsquo;s own earlier titanium dioxide case (&lt;em&gt;Personal Care Products Council v. Bonta&lt;/em&gt;), in which industry groups challenged Proposition 65&amp;rsquo;s warning requirements as unconstitutional compelled speech under the First Amendment, on the theory that a warning resting on unsettled or contested science cannot be purely factual or uncontroversial. Government-mandated commercial disclosures ordinarily need only be &amp;ldquo;purely factual and uncontroversial&amp;rdquo; to survive a relaxed form of First Amendment review that applies specifically to disclosure requirements, rather than the more stringent scrutiny that governs other compelled or restricted commercial speech. &lt;em&gt;Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio&lt;/em&gt;, 471 U.S. 626, 651 (1985). A warning ceases to be purely factual when it asserts a health risk that is not fully established in the scientific community. Where the science is not well established, courts apply the more stringent intermediate scrutiny standard, which requires the government to show that the compelled speech directly advances a substantial interest without being broader than necessary. &lt;em&gt;Nat&amp;rsquo;l Ass&amp;rsquo;n of Wheat Growers v. Bonta&lt;/em&gt;, 85 F.4th 1263, 1283 (9th Cir. 2023) (applying &lt;em&gt;Central Hudson Gas &amp;amp; Electric Corp. v. Public Service Commission of New York&lt;/em&gt;, 447 U.S. 557, 566 (1980)).&lt;/p&gt;
&lt;p&gt;PCPC&amp;rsquo;s complaint made three linked arguments with respect to the DEA warning. First, the warning is not a neutral fact but a compelled false statement &amp;mdash; it requires businesses to tell customers that a product can expose them to a chemical known to cause cancer, which PCPC argued is not true. Second, the science behind adding DEA to the Proposition 65 list is too thin because it is based only on a single study in a cancer-prone mouse strain. A parallel rat study did not find the same link, and no human study has independently concluded that DEA is linked to cancer in humans. Third, because the warning is not purely factual and uncontroversial, the more lenient &lt;em&gt;Zauderer&lt;/em&gt; standard does not apply, and the warning also fails the more stringent level of First Amendment scrutiny because the state has no legitimate interest in forcing a false or misleading warning on a product label.&lt;/p&gt;
&lt;h2&gt;Impact of the Order&lt;/h2&gt;
&lt;p&gt;Rather than litigate the case to a merits ruling, Attorney General Bonta and PCPC entered into a stipulated judgment. Judge Daniel J. Calabretta of the Eastern District of California, Sacramento Division, signed the resulting Order Regarding Final Judgment and Permanent Injunction on June 23, 2026. The Order provides the following relief:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Permanently enjoins the Attorney General, and anyone acting in privity or concert with him, from filing or prosecuting new Proposition 65 suits over DEA in cosmetics and personal care products&lt;/li&gt;
    &lt;li&gt;Declares that, given the current state of the science, the Proposition 65 cancer warning requirement for DEA cannot be enforced consistent with the First Amendment&lt;/li&gt;
    &lt;li&gt;Allows the Attorney General to move under Rule 60(b)(5) or (6) to dissolve the injunction if the facts or the law change&lt;/li&gt;
    &lt;li&gt;Keeps the case open so the court can enforce the injunction going forward&lt;/li&gt;
    &lt;li&gt;Enters judgment for PCPC, with each side covering its own fees and costs&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Notably, Attorney General Bonta did not concede the constitutional argument. The stipulation states he still disputes that the DEA warning violates the First Amendment, but explains that both sides evaluated the current science, the reasoning courts used in the glyphosate, acrylamide, and titanium dioxide cases, and the governing precedent, and concluded that a stipulated judgment was the sensible way to resolve the case.&lt;/p&gt;
&lt;h2&gt;Practical Takeaways&lt;/h2&gt;
&lt;p&gt;The injunction is limited to DEA in cosmetics and personal care products and does not cover DEA exposures posed by other products. But within that scope, the injunction should bar both AG-led enforcement and the private citizen enforcement suits that make up the bulk of actual Proposition 65 litigation. &lt;/p&gt;
&lt;p&gt;Read alongside the glyphosate, acrylamide, and titanium dioxide cases, the DEA order gives industry groups an established blueprint to challenge Proposition 65 warning requirements. When a chemical is listed under Proposition 65 based solely on an IARC determination that the chemical is a &amp;ldquo;probable&amp;rdquo; or &amp;ldquo;possible&amp;rdquo; carcinogen without direct evidence that the chemical is linked to cancer in humans, industry groups will likely sue, and a federal court &amp;mdash; or the state itself, by stipulation &amp;mdash; could conclude that the warning is based on evidence too shaky to survive First Amendment scrutiny. We expect industry groups to continue challenging chemicals on the Proposition 65 list that fall into this category.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{868DC019-585B-43DA-8D86-C09A2DA83858}</guid><link>https://www.biosliceblog.com/2026/08/how-will-the-eu-parliament-shape-the-mdr-ivdr-revision-draft-report-indicates-how-parliament-may-seek-to-amend-commissions-proposals/</link><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher Bates</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bates-christopher</a10:uri><a10:email>christopher.bates@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><title>How Will the EU Parliament Shape the MDR/IVDR Revision? Draft Report Indicates How Parliament May Seek to Amend Commission’s Proposals</title><pubDate>Thu, 06 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{31B72890-E66B-4612-8B42-1C2B3A1AF6AE}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/china-compliance-update-life-sciences-summer-2026</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Siyi Gu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gu-siyi</a10:uri><a10:email>siyi.gu@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Chuqiao Yu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/y/yu-chuqiao</a10:uri><a10:email>chuqiao.yu@cn.arnoldporter.com</a10:email></a10:author><title>China Compliance Update: Life Sciences — Summer 2026</title><description>&lt;p&gt;The first half of 2026 saw continued expansion of China&amp;rsquo;s compliance enforcement affecting life sciences companies, with anti-corruption remaining the primary regulatory focus alongside heightened scrutiny of medical data security, scientific research, public procurement, financial and tax compliance, and medical insurance fund integrity. New regulations governing medical representatives, updated judicial guidance lowering criminal liability thresholds for healthcare bribery, and increased enforcement actions &amp;mdash; including unannounced inspections and enhanced credit evaluation penalties &amp;mdash; underscore regulators&amp;rsquo; expectations for stronger compliance programs, robust third-party oversight, and careful management of interactions with healthcare professionals, research activities, and government procurement processes.&lt;/p&gt;</description><pubDate>Thu, 06 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;In the first half of 2026, anti-corruption enforcement in the life sciences industry remained a major focus for China&amp;rsquo;s regulators. The life sciences sector also saw important developments in data security, public procurement, and management of sales representatives. This Advisory summarizes these developments and outlines compliance considerations for the new environment.&lt;/p&gt;
&lt;h2&gt;Enforcement Focus for 2026&lt;/h2&gt;
&lt;p&gt;On June 8, 2026, China&amp;rsquo;s National Health Commission (NHC), together with 13 other government authorities,[[N:The 13 agencies include the Ministry of Commerce, the Ministry of Education, the Ministry of Finance, the Ministry of Industry and Information Technology, the Ministry of Public Security, the National Administration of Traditional Chinese Medicine, the National Audit Office, the National Disease Control and Prevention Administration, the National Healthcare Security Administration, the National Medical Products Administration, the State Administration for Market Regulation (SAMR), the State Taxation Administration, and the State-owned Assets Supervision and Administration Commission of the State Council (SASAC).]] published the &lt;a rel="noopener noreferrer" href="https://www.nhc.gov.cn/ylyjs/zcwj/202606/76580b7730d841c7ae20cb081396f645.shtml" target="_blank"&gt;2026 Work Priorities for Rectifying Misconduct in the Field of Pharmaceutical Purchase and Sales and Medical Services&lt;/a&gt; (the Work Priorities, 2026&lt;span&gt;年&lt;/span&gt;&lt;span&gt;纠正医药购销领域和医疗服务中不正之风工作要点&lt;/span&gt;). The Work Priorities focus on recurring issues identified in recent years and set out regulatory expectations in 11 areas, including procurement, pricing, medical data, medical insurance, and delivery of healthcare services.&lt;/p&gt;
&lt;h3&gt;Medical Data Governance and Scientific Research Activities &lt;/h3&gt;
&lt;p&gt;For the first time, Article 5 of the Work Priorities elevates medical data security to a standalone priority. The Work Priorities call for strengthened, end-to-end oversight of medical data, including enhanced mechanisms for data use review and accountability, and explicitly prohibit the unauthorized disclosure, sale, or use of medical data. These measures are intended to reinforce protections for patient privacy and personal information.&lt;/p&gt;
&lt;p&gt;The same provision also highlights increased scrutiny of scientific research activities for improper transfers of value. As discussed in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-life-sciences-spring-2026" target="_self"&gt;April 2026 Advisory&lt;/a&gt;, in March 2026, the National Healthcare Security Administration (NHSA) published a case study of an unannounced inspection of an investigator-initiated study (IIS) and discussed irregularities, including payments to Healthcare Professions (HCPs) that appeared to lack clinical value, additional IISs relating to the same drug with vague or overly broad clinical designs, and potentially questionable study deliverables. In the Work Priorities, regulators have further signaled a focus on misconduct involving the use of third parties to transfer improper benefits to HCPs under the guise of legitimate research. This emphasis suggests that authorities are expanding their focus beyond direct interactions between healthcare companies and HCPs to encompass more complex, indirect arrangements, including clinical trials and IIS.&lt;/p&gt;
&lt;h3&gt;HCP Conduct &lt;/h3&gt;
&lt;p&gt;Article 6 of the Work Priorities signals continued regulatory focus on HCP conduct. Regulators will target unauthorized multi-site practice, external consultations conducted without the required institutional approvals, and the use of academic activities as channels for the transfer of improper benefits. The Work Priorities also call for the continued implementation of the Nine Criteria for Honest Practices by Staff of Medical Institutions (&lt;span&gt;医&lt;/span&gt;&lt;span&gt;疗机构工作人员廉洁从业九项准则&lt;/span&gt;) and related professional conduct requirements.&lt;/p&gt;
&lt;h3&gt;Medical Device Procurement&lt;/h3&gt;
&lt;p&gt;Article 7 of the Work Priorities signals continued regulatory focus on government procurement of medical devices. Regulators will target procurement-related misconduct, including improper intervention by key decision-makers, the splitting of projects to circumvent public tender requirements, bid specifications tailored to favor specific suppliers, and other forms of bid-rigging. Authorities also emphasized enforcement against suppliers engaging in license lending, sham transactions, and commercial bribery. &lt;/p&gt;
&lt;p&gt;Consistent with enforcement against &amp;ldquo;rat race competition&amp;rdquo; in other industries, the Work Priorities also call for resolution of the issue of abnormally low-priced bids in the public procurement of medical products and the issue of overdue payments owed by hospitals to suppliers. These priorities likely reflect regulators&amp;rsquo; efforts to maintain a healthy and sustainable business environment in the life sciences industry.&lt;/p&gt;
&lt;h3&gt;Financial and Tax Compliance&lt;/h3&gt;
&lt;p&gt;Article 8 of the Work Priorities reflects enhanced regulatory attention to financial and tax-related misconduct, with particular emphasis on the medical device sector. The provision calls for coordinated and targeted enforcement of practices such as the falsification or alteration of tax invoices,[[N:Called &amp;ldquo;fapiao&amp;rdquo; in Chinese.]] issuance or acceptance of false tax invoices, and concealment of income to evade tax obligations. Notably, regulators will track entities that accept false tax invoices and enhance the credit evaluation mechanism in the medical device sector. These developments suggest that companies may face increased scrutiny not only of their internal financial controls, but also of tax invoices and financial documentation received from their distributors, vendors, and other third parties.&lt;/p&gt;
&lt;h3&gt;Medical Insurance Fund Integrity &lt;/h3&gt;
&lt;p&gt;Article 9 of the Work Priorities underscores a continued focus on safeguarding the integrity of funding for China&amp;rsquo;s state-run medical insurance program through regulation of medical practices and the appropriate use of insurance funds. Regulators will continue to standardize diagnosis, treatment, and billing practices, while strengthening oversight and addressing key deficiencies in the management of the insurance program. &lt;/p&gt;
&lt;h3&gt;Misconduct by Industry Associations&lt;/h3&gt;
&lt;p&gt;Article 10 of the Work Priorities highlights concerns around the practices of healthcare industry associations, such as the lending of their qualifications to other entities, organization of meetings and operation of publications, business outsourcing, sponsorships, donations, and other forms of cooperation, which may be used to obtain improper benefits.&lt;/p&gt;
&lt;h3&gt;Medical Aesthetics&lt;/h3&gt;
&lt;p&gt;Article 10 also signals continued regulatory focus on the medical aesthetics sector. Regulators will target a range of industry misconduct, including the provision of medical aesthetic services without the required qualifications, the operation of &amp;ldquo;fast-track&amp;rdquo; training programs for minimally invasive medical aesthetic procedures, and false or misleading commercial marketing practices.&lt;/p&gt;
&lt;h3&gt;Targeted Enforcement Actions&lt;/h3&gt;
&lt;p&gt;The Work Priorities indicate that regulators will continue to rely on targeted enforcement campaigns and multi-agency investigations to address compliance risks across the healthcare sector. Specified areas of focus include tax-related misconduct in the medical device industry, medical practices, and the use of medical insurance funds. Regulators will also continue conducting targeted reviews of medical ethics and professional conduct, hospital inspections, and investigations into abnormal hospitalization expenses.&lt;/p&gt;
&lt;h2&gt;Administrative Measures for Medical Representatives&lt;/h2&gt;
&lt;p&gt;On April 28, 2026, the National Medical Products Administration (NMPA), together with six other central authorities, jointly issued the &lt;a rel="noopener noreferrer" href="https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20260507180422166.html" target="_blank"&gt;Administrative Measures for Medical Representatives&lt;/a&gt; (the Measures, &lt;span&gt;医&lt;/span&gt;&lt;span&gt;药代表管理办法&lt;/span&gt;), which will take effect on August 1, 2026. The Measures are the final version of a draft that was published for public comment in late 2024. The Measures replace prior regulations issued in 2020 and represent a significant update to the regulatory regime for pharmaceutical sales representatives.&lt;/p&gt;
&lt;p&gt;The Measures tighten the requirements for sales representatives&amp;rsquo; qualifications and impose new compliance obligations on sales representatives, market authorization holders (MAH), and contract sales organizations (CSO). While the Measures only apply to the pharmaceutical sector, the NMPA has announced that similar regulations for the medical device and medtech sector are forthcoming. For further analysis, see our Advisory on &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/06/china-strengthens-management-of-medical-representatives" target="_self"&gt;China&amp;rsquo;s Administrative Measures for Medical Representatives&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;The public disclosure mechanism established by the Measures may already be in use. Media reports indicate that on August 4, 2026, the national medical representative filing platform published its first disclosed violation since the Measures took effect, a finding that a sales representative had conducted academic promotional activities at a healthcare institution without first completing the required filing process. This listing, however, does not appear to be shown on the platform at the time of writing.&lt;/p&gt;
&lt;h2&gt;Interpretation (II) on Corruption and Bribery: Impact on Healthcare&lt;/h2&gt;
&lt;p&gt;On April 10, 2026, the Supreme People&amp;rsquo;s Court (SPC) and the Supreme People&amp;rsquo;s Procuratorate (SPP) jointly issued the &lt;a rel="noopener noreferrer" href="https://www.court.gov.cn/fabu/xiangqing/497181.html" target="_blank"&gt;Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery (II)&lt;/a&gt; (Interpretation (II), &lt;span&gt;关于&lt;/span&gt;&lt;span&gt;办理贪污贿赂刑事案件适用法律若干问题的解释（二）&lt;/span&gt;), which took effect on May 1, 2026. This is the first major update to judicial guidance on this law in a decade. For further analysis, see our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-anti-corruption-spring-2026" target="_self"&gt;China Compliance Update: Anti-Corruption &amp;mdash; Spring 2026&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;Interpretation (II) has three key implications for life sciences companies: &lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;Designates healthcare as a &amp;ldquo;public-interest sector&amp;rdquo; with correspondingly lower thresholds for criminal liability (RMB 100,000 (US$14,286) for individuals, RMB 200,000 (US$28,571) for entities). Under China&amp;rsquo;s regulatory regime, lower levels of corrupt misconduct may be punished under the Anti-Unfair Competition Law, which is an administrative law. Interpretation (II) lowers the threshold at which corrupt misconduct in the life sciences sector will be punished criminally, rather than administratively. &lt;/li&gt;
    &lt;li&gt;Lowers the thresholds for criminal liability for bribery of employees of private hospitals to bring them into line with the thresholds for public HCPs.&lt;/li&gt;
    &lt;li&gt;Creates a clearer path to corporate liability by attributing employees&amp;rsquo; corrupt misconduct to their employer if the illicit gains benefit the employer and the payment(s) were approved by senior management. &lt;/li&gt;
&lt;/ol&gt;
&lt;h2&gt;2026 NHSA Unannounced Inspections&lt;/h2&gt;
&lt;p&gt;On May 14, 2026, the NHSA formally launched the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/5/14/art_14_20502.html" target="_blank"&gt;2026 unannounced inspections&lt;/a&gt; into the use of the national medical insurance fund. On July 9, 2026, the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/7/9/art_14_21357.html" target="_blank"&gt;NHSA reported&lt;/a&gt; that in the first half of 2026, the NHSA had conducted unannounced inspections in all provinces of China, inspecting 2,926 medical institutions, and identifying RMB 1.16 billion in suspected noncompliant use of medical insurance funds. The 2026 inspections focus on areas with elevated risks of misusing medical insurance funding, high-risk therapeutic areas including orthopedics, hemodialysis, and laboratory testing, and institutions with major indications of noncompliance. &lt;/p&gt;
&lt;p&gt;In addition to focusing on misuse of the public medical insurance fund, the NHSA identified issues with investigator-initiated studies and public procurement process in prior unannounced inspections. See our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-life-sciences-spring-2026" target="_self"&gt;China Compliance Update: Anti-Corruption &amp;mdash; Spring 2026&lt;/a&gt; for further analysis of the case studies published by the NHSA for prior unannounced inspections. &lt;/p&gt;
&lt;h2&gt;NHSA Alert on Expert Recommendations in VBP Programs&lt;/h2&gt;
&lt;p&gt;On July 7, 2026, the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/7/7/art_14_21332.html" target="_blank"&gt;NHSA published an alert&lt;/a&gt; concerning improper interference with centralized volume-based procurement (VBP). During the selection of products for the twelfth round of national drug procurement, a multinational pharmaceutical company submitted a purported &amp;ldquo;expert recommendation letter&amp;rdquo; bearing the signatures of 78 doctors from 31 hospitals in an attempt to influence the selection process. The NHSA found that more than 80% of the signatures were falsified or obtained under false pretenses, including signatures forged by company sales personnel, copied from other materials, or attributed to non-existent HCPs. Some genuine signatures had reportedly been obtained under the guise of &amp;ldquo;after-sales follow-up&amp;rdquo; or &amp;ldquo;research questionnaires.&amp;rdquo; The NHSA warned companies not to interfere with centralized procurement through unlawful or non-compliant means. The NHSA did not state whether the implicated company was penalized.&lt;/p&gt;
&lt;p&gt;This is the first time that the NHSA has issued a public notice regarding issues with expert recommendations. Manufacturers participating in China&amp;rsquo;s centralized procurement programs frequently collect recommendations from clinical experts in support of their applications. &lt;/p&gt;
&lt;h2&gt;Enforcement Case Studies&lt;/h2&gt;
&lt;p&gt;In the first half of 2026, the NHSA published three enforcement case studies. All three cases show that regulators are actively utilizing the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2025/6/5/art_104_16740.html" target="_blank"&gt;updated credit-evaluation mechanism promulgated in June 2025&lt;/a&gt;[[N:For further analysis of the credit-evaluation mechanism, see our China Compliance Update: Life Sciences &amp;mdash; Summer 2025. ]] as a penalty for commercial bribery in the life sciences sector.&lt;/p&gt;
&lt;p&gt;
&lt;table&gt;
    &lt;tbody&gt;
        &lt;tr&gt;
            &lt;td&gt;No.&lt;/td&gt;
            &lt;td&gt;Summary&lt;/td&gt;
            &lt;td&gt;Notes&lt;/td&gt;
        &lt;/tr&gt;
        &lt;tr&gt;
            &lt;td style="text-align: center; vertical-align: top;"&gt;1&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;
            &lt;p&gt;In &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/7/28/art_14_21585.html" target="_blank"&gt;July 2026&lt;/a&gt;, the NHSA published a criminal case in which an HCP at a public hospital in Henan province illegally accepted US$10,000 in cash, as well as shopping cards and other items of value totaling RMB 25,475,000 (US$3,639,286) from pharmaceutical and medical device distributors. &lt;/p&gt;
            &lt;span&gt;The HCP was sentenced to 11 years in prison and fined RMB 2,300,000 (US$328,571). The illegal proceeds of RMB 25,475,000 (US$3,639,286) and US$10,000 were confiscated.&lt;/span&gt;&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;&lt;span&gt;Regulators conducted updated credit evaluations of the implicated distributors and manufacturers. Distributors were encouraged to provide evidence identifying the manufacturers. All 10 manufacturers implicated received some degree of &amp;ldquo;dishonest&amp;rdquo; rating. Some of the manufacturers corrected their misconduct by submitting reports documenting their remediation measures, reducing inflated pricing margins, and returning improper gains. Three manufacturers refused to correct their conduct and have been subjected to unspecified additional restrictions.&lt;/span&gt;&lt;/td&gt;
        &lt;/tr&gt;
        &lt;tr&gt;
            &lt;td style="text-align: center; vertical-align: top;"&gt;2&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;
            &lt;p&gt;In &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/4/9/art_14_20143.html" target="_blank"&gt;April 2026&lt;/a&gt;, the NHSA published a criminal case in which an HCP at a public hospital in Qinghai province with a leadership role accepted bribes from a pharmaceutical manufacturer and a medical device manufacturer.&lt;/p&gt;
            &lt;span&gt;The HCP was convicted of accepting bribes and sentenced to three years in prison and fined RMB 300,000 (US$42,857). Penalties imposed on the implicated companies, if any, have not been publicly disclosed.&lt;/span&gt;&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;
            &lt;p&gt;The findings triggered a credit-evaluation process against the implicated manufacturers.&lt;/p&gt;
            &lt;p&gt;One company remedied its misconduct before the official credit evaluation result was issued and did not receive a negative evaluation.&lt;/p&gt;
            &lt;p&gt;The other company failed to take any remedial action, received an &amp;ldquo;Extremely Dishonest&amp;rdquo; evaluation, and was debarred from public procurement in Qinghai province for three years.&lt;/p&gt;
            &lt;/td&gt;
        &lt;/tr&gt;
        &lt;tr&gt;
            &lt;td style="text-align: center; vertical-align: top;"&gt;3&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;
            &lt;p&gt;In &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/1/11/art_14_19315.html" target="_blank"&gt;January 2026&lt;/a&gt;, the NHSA published a case in which a CSO was engaged by a distributor to promote an injectable product. The CSO&amp;rsquo;s sales director paid RMB 35,046 (US$5,007) in kickbacks to a public HCP in exchange for increased prescriptions.&lt;/p&gt;
            &lt;span&gt;The CSO was fined RMB 300,000 (US$42,857) for commercial bribery under Article 7 of the Anti-Unfair Competition Law.&lt;/span&gt;&lt;/td&gt;
            &lt;td style="text-align: left; vertical-align: top;"&gt;&lt;span&gt;The findings triggered the credit-evaluation process against the distributor. The distributor was required to identify the manufacturer responsible for the misconduct. The manufacturer was also subjected to the credit-evaluation process, although the NHSA did not publish the results of the manufacturer&amp;rsquo;s credit evaluation.&lt;/span&gt;&lt;/td&gt;
        &lt;/tr&gt;
    &lt;/tbody&gt;
&lt;/table&gt;
&lt;/p&gt;
&lt;h2&gt;Takeaways&lt;/h2&gt;
&lt;p&gt;
&lt;p style="margin-bottom: 12pt; line-height: normal;"&gt;As Chinese regulators continue to prioritize enforcement across multiple facets of the life sciences industry, companies operating in China should proactively assess their compliance posture.&amp;nbsp;&lt;/p&gt;
&lt;ol&gt;
    &lt;li style="margin-bottom: 12pt; line-height: normal;"&gt;Anti-corruption enforcement in the life sciences sector remains a major focus for regulators. Companies should continue to look closely at high-risk areas such as sponsorships or donations to healthcare organizations, academic conferences and medical education programs, and HCP engagements such as consulting arrangements and speaker programs. These arrangements should be supported by legitimate business or academic needs, appropriate approvals, fair-market-value assessments, and adequate documentation.&lt;/li&gt;
    &lt;li style="margin-bottom: 12pt; line-height: normal;"&gt;Medical insurance fraud remains another area of enforcement focus. With the launch of the NHSA&amp;rsquo;s 2026 unannounced inspection program, we expect to see more enforcement cases and potentially increased scrutiny on manufacturers relating to public procurement and interactions with public hospitals and HCPs.&lt;/li&gt;
    &lt;li style="margin-bottom: 12pt; line-height: normal;"&gt;Regulators are also paying close attention to other areas, including medical data security, scientific research activities, medical device procurement, financial and tax compliance, and medical aesthetics.&lt;/li&gt;
    &lt;li style="margin-bottom: 12pt; line-height: normal;"&gt;Companies should review their compliance training programs and policies and procedures to ensure they are aligned with regulators&amp;rsquo; changing priorities. &lt;/li&gt;
    &lt;li style="margin-bottom: 12pt; line-height: normal;"&gt;Increasing enforcement against companies for their distributors&amp;rsquo; misconduct highlights the importance of strong third-party due diligence and monitoring programs.&lt;/li&gt;
&lt;/ol&gt;
&lt;/p&gt;
&lt;p&gt;* &lt;em&gt;Xuan Chen contributed to this Advisory. Xuan is employed as a China Associate in Arnold &amp;amp; Porter&amp;rsquo;s Shanghai office&lt;/em&gt;.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{07D4A416-E55A-4DEA-9D1E-9F4632BEE0BF}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/daily-journal-features-joel-greenberg-and-sara-adler-on-the-secs-extended-hours-trading-proposal</link><title>Daily Journal  Features Joel Greenberg and Sara Adler on the SEC’s Extended-Hours Trading Proposal</title><description>&lt;p&gt;Joel Greenberg, senior counsel, and Sara Adler, counsel, of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance practice, were quoted in the &lt;em&gt;Daily Journal&lt;/em&gt; article, &amp;ldquo;The Market That Never Sleeps,&amp;rdquo; on the Securities and Exchange Commission's (SEC) upcoming roundtable to discuss moving toward 24-hour trading in the U.S. equity markets.&lt;/p&gt;</description><pubDate>Wed, 05 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Joel Greenberg, senior counsel, and Sara Adler, counsel, of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance practice, were quoted in the &lt;em&gt;Daily Journal&lt;/em&gt; article, &amp;ldquo;The Market That Never Sleeps,&amp;rdquo; on the Securities and Exchange Commission's (SEC) upcoming roundtable to discuss moving toward 24-hour trading in the U.S. equity markets.&lt;/p&gt;
&lt;p&gt;Sara discussed the regulatory timeline for implementing extended-hours trading, noting that Nasdaq&amp;rsquo;s new 23-hour-a-day, 5-day-a-week systems could become operational as early as December, pending final SEC approval. She also acknowledged that while longer trading hours will introduce new operational and market risks for exchanges, public companies, and investors, established exchanges and SEC oversight should help mitigate many of those concerns.&lt;/p&gt;
&lt;p&gt;Joel explained that investor demand for near-continuous access to the markets has been building for years, observing that "there's so much pressure to trade outside of normal hours that people find a way." He noted that trading already occurs through alternative venues but emphasized that national securities exchanges would provide greater efficiency and transparency for investors. Highlighting the increasing pace of global information flow, Joel added, "They're going to do it because we have been&amp;mdash;in for the past 10 or 20 years&amp;mdash;in an environment where traders get enough of an information flow where they want to react instantly to news." Looking ahead, he observed that the SEC may need to expand the availability of its EDGAR filing system to ensure investors have timely access to material disclosures whenever markets are open, concluding, "It's going to happen. There's a lot to be figured out."&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.dailyjournal.com/articles/393415-the-market-that-never-sleeps"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{6F4FC32B-4DF3-4C5B-85F0-7E86D0ACCD9A}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/sheila-boston-receives-margaret-brent-women-lawyers-of-achievement-award</link><title>American Bar Association Honors Sheila Boston with 2026 Margaret Brent Women Lawyers of Achievement Award</title><description>The American Bar Association (ABA) Commission on Women in the Profession presented Arnold &amp;amp; Porter partner Sheila S. Boston with its 2026 Margaret Brent Women Lawyers of Achievement Award on August 2, at the ABA Annual Meeting in Chicago.</description><pubDate>Wed, 05 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The American Bar Association (ABA) Commission on Women in the Profession presented Arnold &amp;amp; Porter partner Sheila S. Boston with its 2026 Margaret Brent Women Lawyers of Achievement Award on August 2, at the ABA Annual Meeting in Chicago.&lt;/p&gt;
&lt;p&gt;The Margaret Brent Women Lawyers of Achievement Award recognizes women lawyers "who have achieved professional excellence in their area of specialty and have actively paved the way to success for others." Each year, the ABA Commission on Women in the Profession presents the award to up to five women lawyers who have achieved professional excellence and paved the way for other women in the legal profession.&lt;/p&gt;
&lt;p&gt;The ABA commended Sheila as "a seasoned trial lawyer and litigation strategist who defends clients from the initiation of a case through trial and resolution." The organization also noted she is active in bar associations and currently serves as vice president of the Federal Bar Council. She previously served as president of the New York City Bar Association, for which she was the first woman of color to hold the role.&lt;/p&gt;
&lt;p&gt;Established in 1991, the Margaret Brent Women Lawyers of Achievement Award is named for Margaret Brent, the first woman lawyer in America. Past honorees include U.S. Supreme Court justices, legislators, scholars, civil rights activists, and corporate lawyers. Winners are selected based on "their professional accomplishments and their role in opening doors of opportunity for other women lawyers."&lt;/p&gt;
&lt;p&gt;The honor follows a series of recent recognitions for Sheila, who earlier this year was named to &lt;em&gt;Forbes'&lt;/em&gt; inaugural &lt;a href="/en/perspectives/news/2026/06/forbes-names-2026-americas-top-women-lawyers-list"&gt;America's Top Women Lawyers&lt;/a&gt;&amp;nbsp;list and &lt;em&gt;Crain&amp;rsquo;s New York Business&amp;rsquo;s&amp;nbsp;&lt;a href="/en/perspectives/news/2026/03/crains-new-york-business-names-sheila-boston-melida-hodgson-and-jami-vibbert"&gt;&amp;lsquo;Notable Women in Law&amp;rsquo;&lt;/a&gt;&amp;nbsp;&lt;/em&gt;List. Last year, the New York City Bar Association honored her with a &lt;a href="/en/perspectives/news/2025/11/new-york-city-bar-association-honors-sheila-boston"&gt;historic portrait unveiling&lt;/a&gt;, and the National Bar Association recognized her as one of its &lt;a href="/en/perspectives/news/2025/08/sheila-boston-receives-honors-at-nba-centennial-convention"&gt;Centennial Lawyers of Distinction&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{14201E31-DEE8-4E42-AD65-550B2F70F760}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/law360-interviews-lisa-re-on-cms-new-exclusion-authority</link><title>Law360 Interviews Lisa Re on CMS’ New Exclusion Authority</title><description>Lisa Re, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Assistant Inspector General for Legal Affairs at the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), was quoted in the recent&lt;em&gt; Law360&lt;/em&gt; article, &amp;ldquo;Lawyers Eye CMS&amp;rsquo; New Power To Freeze Medicaid Funds,&amp;rdquo; discussing the implications of HHS expanding exclusion authority to the Centers for Medicare &amp;amp; Medicaid Services (CMS).</description><pubDate>Wed, 05 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Lisa Re, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Assistant Inspector General for Legal Affairs at the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), was quoted in the recent &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Lawyers Eye CMS&amp;rsquo; New Power To Freeze Medicaid Funds,&amp;rdquo; discussing the implications of HHS expanding exclusion authority to the Centers for Medicare &amp;amp; Medicaid Services (CMS).&lt;/p&gt;
&lt;p&gt;Because OIG has typically handled exclusion authority, Lisa emphasized that CMS&amp;rsquo; new role could strengthen the government's healthcare fraud enforcement efforts.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;This is going to be a force multiplier,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;She also noted that the expanded authority raises questions about how exclusion responsibilities will be divided between OIG and CMS, including whether the agencies will share authority or focus on different types of exclusions.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;It all depends on how they write it in the delegation,&amp;rdquo; Lisa said. &amp;ldquo;The devil&amp;rsquo;s in the details there.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/healthcare-authority/articles/2505069?"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7C3A181C-ED1F-4EE2-A78A-DECB775F987A}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/law360-names-tom-pettit-to-2026-rising-stars-list</link><title>Law360 Names Tom Pettit to 2026 ‘Rising Stars’ List</title><description>Arnold &amp;amp; Porter Government Contracts senior associate Tom Pettit was named to&lt;em&gt; Law360's &lt;/em&gt;2026 list of "Rising Stars." The annual report recognizes attorneys under 40 "whose legal accomplishments belie their age." Honorees were selected based on their career accomplishments in their respective disciplines.</description><pubDate>Wed, 05 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Government Contracts senior associate Tom Pettit was named to&lt;em&gt; Law360's&lt;/em&gt; 2026 list of "Rising Stars." The annual report recognizes attorneys under 40 "whose legal accomplishments belie their age." Honorees were selected based on their career accomplishments in their respective disciplines.&lt;/p&gt;
&lt;p&gt;Tom represents government contractors across industries in litigation, including bid protests, contract claims, and prime-subcontractor disputes before the U.S. Government Accountability Office, U.S. Court of Federal Claims, U.S. Court of Appeals for the Federal Circuit, Boards of Contract Appeals, Small Business Administration Office of Hearings and Appeals, and other forums. He also advises companies on mergers and acquisitions involving government contractors; represents government contractors in internal and government investigations; and advises government contractors on a variety of regulatory compliance issues, including cybersecurity and small business matters. Tom is a U.S. Marine Corps veteran of Operation Iraqi Freedom. He is well-versed in the needs and concerns of the defense, aerospace, intelligence, and national security communities.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{82C5F22D-910A-470E-A885-FC80233201B5}</guid><link>https://www.biosliceblog.com/2026/08/the-eu-data-acts-access-by-design-deadline-what-life-sciences-companies-need-to-know-before-september-2026/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Camille Vermosen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vermosen-camille</a10:uri><a10:email>camille.vermosen@arnoldporter.com</a10:email></a10:author><title>The EU Data Act’s Access-by-Design Deadline: What Life Sciences Companies Need to Know Before September 2026</title><pubDate>Wed, 05 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{E2478A73-C522-4BAE-A7FE-0E84F658F49C}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/stacey-halliday-and-jennifer-kwapisz-talk-to-inside-epa-about-oregon-california-epr-laws</link><title>Stacey Halliday and Jennifer Kwapisz Talk to Inside EPA about Oregon, California EPR Laws</title><description>Arnold &amp;amp; Porter Environmental partner Stacey Halliday and Product Liability Litigation partner Jennifer Kwapisz were quoted in the recent&lt;em&gt; Inside EPA &lt;/em&gt;article, &amp;ldquo;Briefing On Due Process Claims Could Limit Impact Of Oregon EPR Suit,&amp;rdquo; discussing Judge Michael Simon&amp;rsquo;s order for post-trial briefing in &lt;em&gt;National Association of Wholesaler-Distributors (NAW) v. Feldon,&lt;/em&gt; the first extended producer responsibility (EPR) lawsuit to go to trial.</description><pubDate>Tue, 04 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Environmental partner Stacey Halliday and Product Liability Litigation partner Jennifer Kwapisz were quoted in the recent &lt;em&gt;Inside EPA&lt;/em&gt; article, &amp;ldquo;Briefing On Due Process Claims Could Limit Impact Of Oregon EPR Suit,&amp;rdquo; discussing Judge Michael Simon&amp;rsquo;s order for post-trial briefing in &lt;em&gt;National Association of Wholesaler-Distributors (NAW) v. Feldon,&lt;/em&gt; the first extended producer responsibility (EPR) lawsuit to go to trial.&lt;/p&gt;
&lt;p&gt;Jennifer highlighted that if the judge&amp;rsquo;s ruling ultimately focuses on NAW&amp;rsquo;s Commerce Clause claims rather than due process arguments, the impact will be broader.&lt;/p&gt;
&lt;p&gt;In that case, &amp;ldquo;it&amp;rsquo;s likely to have more far-ranging implications, because all these packaging EPR programs are having a somewhat similar impact on the stream of commerce,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;To prove its Commerce Clause claims, NAW would need to show the practical import of the EPR program on interstate commerce, which Jennifer noted may be difficult.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;The dormant Commerce Clause is a challenging area of the law, and it&amp;rsquo;s not entirely clear from Supreme Court precedent just what quantum of evidence is going to be needed to satisfy the standard,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;Stacey emphasized that because the court is likely to act quickly, the decision could have implications for California&amp;rsquo;s similar packaging EPR program, while the impacts on other states may be more limited.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;Implementation will likely just be in a wait-and-see mode,&amp;rdquo; she said, in reference to other states&amp;rsquo; packaging EPR programs that are in earlier stages.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://insideepa.com/daily-news/briefing-due-process-claims-could-limit-impact-oregon-epr-suit?0=ip_login_no_cache%3D1a886bdaada746f0e3361343de0b0769"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{49FD8449-ECC2-4430-BF91-7C3E9198D3DE}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-welcomes-ma-private-equity-partner-chee-kwan-kim-to-seoul-office</link><title>Arnold &amp; Porter Welcomes M&amp;A, Private Equity Partner Chee-Kwan Kim to Seoul Office, Bolstering Transactional Capabilities</title><description>&lt;strong&gt;SEOUL and WASHINGTON, D.C., August 3, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Chee-Kwan Kim has joined the firm&amp;rsquo;s M&amp;amp;A team of its Corporate &amp;amp; Finance practice as a partner. CK will be resident in the firm&amp;rsquo;s Seoul office.</description><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;SEOUL and WASHINGTON, D.C., August 3, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Chee-Kwan Kim has joined the firm&amp;rsquo;s M&amp;amp;A team of its Corporate &amp;amp; Finance practice as a partner. CK will be resident in the firm&amp;rsquo;s Seoul office.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;James K. Lee, Managing Partner of Arnold &amp;amp; Porter&amp;rsquo;s Seoul office, said: &amp;ldquo;CK is well regarded in both the business and legal community as an excellent U.S.-qualified lawyer and a trusted advisor whom clients turn to for their most complex transactions. We are confident his business acumen and experience in M&amp;amp;A and private equity will meaningfully augment our existing capabilities in the Korean market.&amp;rdquo;&amp;nbsp; &lt;/p&gt;
&lt;p&gt;Derek Stoldt, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance Group, added: &amp;ldquo;Outbound M&amp;amp;A from Korea remains active and increasingly complex, often involving significant regulatory considerations and cross-jurisdictional structuring and coordination. CK&amp;rsquo;s experience with private equity &amp;mdash;&amp;nbsp;which continues to drive M&amp;amp;A activity in Korea &amp;mdash;&amp;nbsp;positions him to collaborate effectively with our U.S. and global multidisciplinary teams to advise large corporations investing internationally on Korea-originated deal flow.&amp;rdquo;&amp;nbsp; &lt;/p&gt;
&lt;p&gt;CK brings nearly two decades of experience counseling clients on complex, high-value, cross-border mergers and acquisitions, as well as private equity investments. He often represents Korean corporations and sponsors in their strategic transactions, with a particular focus on outbound investments. He regularly advises on acquisitions, dispositions, joint ventures, and minority investments. CK&amp;rsquo;s background also spans multiple industries, including industrials, life sciences, cosmetics, consumer products, and financial services. Before joining Arnold &amp;amp; Porter, CK worked at leading Korean- and U.S.-based law firms.&lt;/p&gt;
&lt;p&gt;In joining the firm, CK said: &amp;ldquo;My practice has centered on complex, multi-step cross-border transactions that require close coordination across jurisdictions. Arnold &amp;amp; Porter&amp;rsquo;s transactional, regulatory, and sector practices align closely with my work, offering significant opportunities for cross-practice collaboration, and I look forward to building on my practice here.&amp;rdquo;&amp;nbsp;&amp;nbsp;  &lt;/p&gt;
&lt;p&gt;CK earned his J.D. from Columbia University, his LL.M. from the University of Toronto, and his LL.B. from Yonsei University.&lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{CE0ABE52-F4FF-4D6C-942F-C93378794796}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/08/arnold-porter-seattle-office-expands-with-life-sciences-and-technology-transactions</link><title>Arnold &amp; Porter Seattle Office Expands with Life Sciences and Technology Transactions Partner Ken Miller</title><description>&lt;strong&gt;SEATTLE, August 3, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Ken Miller has joined the Life Sciences and Technology Transactions teams of the firm&amp;rsquo;s Corporate &amp;amp; Finance practice as a partner. Ken will reside in the firm&amp;rsquo;s Seattle office.&amp;nbsp;</description><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;SEATTLE, August 3, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Ken Miller has joined the Life Sciences and Technology Transactions teams of the firm&amp;rsquo;s Corporate &amp;amp; Finance practice as a partner. Ken will reside in the firm&amp;rsquo;s Seattle office. &lt;/p&gt;
&lt;p&gt;The firm&amp;rsquo;s Seattle office serves as a hub for regulatory, litigation, and transactional work across key practices, including corporate and technology transactions, real estate, class actions, complex commercial litigation, employment disputes, and healthcare and hospital matters. With Ken&amp;rsquo;s arrival, Arnold &amp;amp; Porter&amp;rsquo;s team in the heart of downtown Seattle has increased to 40 attorneys and staff since opening the office in July 2025. Building on this steady and purposeful growth, the firm expects to continue expanding its team in the region.&lt;/p&gt;
&lt;p&gt;Pallavi Mehta Wahi, chair of Western U.S. Strategic Growth and head of Arnold &amp;amp; Porter&amp;rsquo;s Seattle office, said: &amp;ldquo;Ken brings a combination of deep regional roots and global experience, spending his entire career in the Pacific Northwest while working on transactions in global health, technology, and life sciences. That blend is exactly what our clients in this region need, and it reflects what Arnold &amp;amp; Porter is building here in Seattle.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Derek Stoldt, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance group, added: &amp;ldquo;Ken has a strong track record advising clients on the full range of technology and life sciences transactions, both in private practice and in-house. He knows this market well and will be a valuable addition to our Corporate &amp;amp; Finance team, while also expanding our highly regarded tax-exempt practice to the West Coast.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Dan Kracov, chair of the firm&amp;rsquo;s Global Life Sciences Industry group, commented: &amp;ldquo;Ken understands global life sciences work from the inside out. That perspective, paired with his transactional skill, makes him a natural fit for our group and a real asset to clients working across borders and disciplines.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;Ken brings more than 25 years of experience leading complex, high-value, multiparty transactions in technology, life sciences, and global health. Ken joined Arnold &amp;amp; Porter from the Gates Foundation, where he served for over a decade, most recently as Deputy General Counsel. In that role, Ken led legal strategy for the organization&amp;rsquo;s $1.8 billion global health portfolio. He structured transactions that have transformed how life-saving therapies are developed, manufactured, financed, and delivered to the people who need them most. This includes a global tuberculosis vaccine program, a landmark public-private initiative spanning pharma, philanthropic capital, and global health organizations, now in Phase 3 clinical trials with 20,000 participants across five countries.&lt;/p&gt;
&lt;p&gt;Prior to joining the Gates Foundation, Ken spent 17 years in private practice at an Am Law 100 firm. There, he built a technology transactions practice focused on strategic licensing, IP acquisitions, investments, collaborations, and M&amp;amp;A. Ken&amp;rsquo;s technology transactions experience spans a wide range of industries, including life sciences, semiconductor, and software, giving him a distinctive ability to structure complex transactions where these sectors converge. He has also clerked for the Washington State Supreme Court and the Washington State Court of Appeals.&lt;/p&gt;
&lt;p&gt;In joining the firm, Ken said: &amp;ldquo;We are entering a remarkable period of innovation in life sciences, technology, and global health, and clients increasingly need advisors who understand both the transactional and regulatory dimensions of that innovation. Arnold &amp;amp; Porter has built something distinctive: deep life sciences, technology, regulatory and tax-exempt capability combined with a serious commitment to Seattle at exactly the moment this region is defining itself as a global center for AI-driven innovation. I have spent my career in the Pacific Northwest working on some of the most complex transactions in global health and technology, and I can&amp;rsquo;t think of a better platform or a better moment to build the next chapter of that work.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Ken earned his J.D. from Seattle University School of Law and his B.A. from the University of Puget Sound.&lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{804ECA74-8BA2-4650-9626-E4CEC6B6B0B0}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/08/howard-sklamberg-discusses-fda-oversight-of-compounded-peptides-in-womens-health</link><title>Howard Sklamberg Discusses FDA Oversight of Compounded Peptides in Women's Health</title><description>Howard Sklamberg, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the &lt;em&gt;Women's Health &lt;/em&gt;article, &amp;ldquo;You Might Be Able to Purchase Peptides Soon&amp;mdash;but That Doesn&amp;rsquo;t Mean They&amp;rsquo;re FDA-Approved,&amp;rdquo; which explores the FDA advisory committee's recommendation to allow certain peptides to be compounded under Section 503A and the regulatory and public health implications of that decision.</description><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Howard Sklamberg, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the &lt;em&gt;Women's Health&lt;/em&gt; article, &amp;ldquo;You Might Be Able to Purchase Peptides Soon&amp;mdash;but That Doesn&amp;rsquo;t Mean They&amp;rsquo;re FDA-Approved,&amp;rdquo; which explores the FDA advisory committee's recommendation to allow certain peptides to be compounded under Section 503A and the regulatory and public health implications of that decision.&lt;/p&gt;
&lt;p&gt;Howard explained that the advisory committee's recommendation marked a significant departure from the FDA's traditional scientific review process, noting that "the most abnormal thing here is the advisory committee overruling FDA scientists in a wholesale fashion." He also emphasized that inclusion on the 503A bulk drug substances list should not be confused with FDA approval, highlighting that FDA-approved drugs undergo rigorous premarket review and are manufactured under current good manufacturing practices (CGMP), which provide substantially greater safeguards than those applicable to most compounded drugs. As Howard noted, "That is a much more protective set of regulations for manufacturing than applied to typical compounded drugs."&lt;/p&gt;
&lt;p&gt;Looking ahead, Howard cautioned that if the FDA ultimately follows the committee's recommendation, the decision could "open up a can of worms" by encouraging additional manufacturers to pursue the compounding pathway rather than the traditional FDA approval process. He further warned that if compounded peptide products proliferate faster than the agency can oversee them, "you are going to have people who get hurt."&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.womenshealthmag.com/health/a73320848/peptides-fda-compounding/"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E1B39D4D-8B2F-4980-849B-BE48B53D8FEF}</guid><link>https://www.biosliceblog.com/2026/08/virtual-and-digital-health-digest-july-2026/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><title>Virtual and Digital Health Digest – July 2026</title><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{EA2EE07F-D48F-4672-B3BF-BEDE12F14F65}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/leaving-las-vegas-third-circuit-breaks-from-ninth-circuit-ruling-on-algorithmic-pricing-claims</link><a10:author><a10:name>Andre Geverola</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/geverola-andre</a10:uri><a10:email>andre.geverola@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>C. Scott Lent</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lent-c-scott</a10:uri><a10:email>scott.lent@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Leah J. Harrell</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/harrell-leah-j</a10:uri><a10:email>leah.harrell@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alejandra C. Uria</a10:name><a10:uri>https://www.arnoldporter.com/en/people/u/uria-alejandra-c</a10:uri><a10:email>alejandra.uria@arnoldporter.com</a10:email></a10:author><title>Leaving Las Vegas: Third Circuit Breaks From Ninth Circuit Ruling on Algorithmic Pricing Claims</title><description>On July 29, 2026, in &lt;em&gt;Cornish-Adebiyi v. Caesars Entertainment, Inc.&lt;/em&gt;, the Third Circuit reversed the dismissal of a putative class action alleging that Atlantic City casino-hotels conspired to fix guest-room rates through a common pricing algorithm.&amp;nbsp; It is the first federal appellate court to allow algorithmic price-fixing claims to survive a motion to dismiss.</description><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On July 29, 2026, in &lt;em&gt;Cornish-Adebiyi v. Caesars Entertainment, Inc.&lt;/em&gt;, the Third Circuit reversed the dismissal of a putative class action alleging that Atlantic City casino-hotels conspired to fix guest-room rates through a common pricing algorithm.[[N: &lt;em&gt;Cornish-Adebiyi v. Caesars Entertainment, Inc.&lt;/em&gt;, No. 24-3006 (3d Cir. July 29, 2026) (Op.).]] It is the first federal appellate court to allow algorithmic price-fixing claims to survive a motion to dismiss. The decision comes less than a year after the Ninth Circuit became the first federal appellate court to address the antitrust implications of algorithmic pricing in &lt;em&gt;Gibson v. Cendyn Group, LLC&lt;/em&gt; &amp;mdash; where it upheld the district court&amp;rsquo;s dismissal of a complaint involving Las Vegas casino-hotels using the same algorithmic pricing software.[[N: See Andre Geverola, C. Scott Lent, Leah J. Harrell &amp;amp; Zoe Staum, &amp;ldquo;Ninth Circuit Clarifies Antitrust Implications of Algorithmic Pricing&amp;rdquo; (Arnold &amp;amp; Porter Advisory, Aug. 25, 2025); &lt;em&gt;Gibson v. Cendyn Grp., LLC&lt;/em&gt;, 148 F.4th 1069 (9th Cir. 2025).]] While both cases involved the use of the same software, the differing outcomes illustrate not a conflicting approach to the applicable legal standards but to differences in the facts alleged. The Third Circuit found a viable antitrust claim because it concluded that the complaint adequately alleged a horizontal agreement among competitors and that the software used competitors&amp;rsquo; non-public, competitively sensitive information to recommend pricing.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;In &lt;em&gt;Cornish-Adebiyi&lt;/em&gt;, Plaintiffs allege that each casino-hotel fed its current, non-public pricing and occupancy data into the pricing software, which processed that data alongside competitors&amp;rsquo; data to generate recommended room rates that the hotels accepted roughly 90% of the time, producing rates that rose in parallel even as occupancy fell.[[N: Op. at 9-10, 29 (citing CAC &amp;para;&amp;para; 6-9, 137-39, 242-50) (non-public data fed to Cendyn&amp;rsquo;s Rainmaker suite; approximately 90% acceptance; parallel rate increases as occupancy declined).]] In September 2024, the District of New Jersey dismissed the complaint, following the district court&amp;rsquo;s reasoning in &lt;em&gt;Gibson&lt;/em&gt; and finding no adequate allegation of a &amp;ldquo;rim&amp;rdquo; to the alleged hub-and-spoke agreement (i.e., no horizontal agreement among the hotels).[[N: &lt;em&gt;Cornish-Adebiyi v. Caesars Ent., Inc.&lt;/em&gt;, No. 1:23-CV-02536-KMW-EAP, 2024 WL 4356188 (D.N.J. Sept. 30, 2024), rev&amp;rsquo;d and remanded, No. 24-3006, 2026 WL 2182291 (3d Cir. July 29, 2026).]] The court cited the hotels&amp;rsquo; staggered adoption of the software over a 14-year period, the absence of allegations that data was &amp;ldquo;pooled&amp;rdquo; or &amp;ldquo;commingled,&amp;rdquo; and the hotels&amp;rsquo; retention of final pricing authority.[[N: Id. at *4-5, *7 (staggered adoption; no allegation data was &amp;ldquo;pooled or otherwise commingled&amp;rdquo;; retained pricing authority; conspiracy &amp;ldquo;lacks a rim&amp;rdquo;).]]&lt;/p&gt;
&lt;h2&gt;Third Circuit Opinion&lt;/h2&gt;
&lt;p&gt;The Third Circuit reversed the dismissal, holding that the allegations, taken as true, plausibly support an inference that the competitor hotels agreed to fix room rates through the software.[[N: Op. at 10 (&amp;ldquo;We hold that the well-pleaded allegations in the CAC are sufficient to support a finding that casino-hotel Defendants have conspired to fix prices through Cendyn&amp;rsquo;s software.&amp;rdquo;).]] The opinion reasoned that AI-enabled pricing tools could bridge the communication and monitoring gaps that historically made collusion difficult, allowing competitors to coordinate prices &amp;ldquo;without ever communicating with each other&amp;rdquo; and to police deviations in real time.[[N: Op. at 18 (discussing the capacity of AI-enabled algorithms to facilitate coordination and real-time monitoring).]] At the same time, the court took pains to note that there is nothing inherently unlawful about using pricing algorithms, and that its decision made no findings about how the software actually works.[[N: Op. at 13, 39 (noting there is &amp;ldquo;nothing inherently wrong&amp;rdquo; with using algorithms to compete more effectively, and that the court makes no assumptions about how Cendyn&amp;rsquo;s software works).]]&lt;/p&gt;
&lt;p&gt;According to the court, the complaint adequately alleged that each hotel understood that its pricing recommendations were built on the non-public data all users supplied and that each &amp;ldquo;was committed to a common plan of setting room rates based on the recommended rates received from [the] software &amp;hellip; while also &amp;lsquo;knowing that their competitors would not lower their room rates to take market share.&amp;rsquo;&amp;rdquo;[[N: Op. at 37.]] While the court acknowledged that information exchanges even among competitors are not &lt;em&gt;per se&lt;/em&gt; unlawful, it held that the alleged exchanges of current pricing and occupancy data were adequately alleged to &amp;ldquo;faciliat[e] collusive conduct.&amp;rdquo;[[N: Op. at 36-38 (holding that requiring plaintiffs to plead how the proprietary algorithm works is inappropriate at the pleading stage; quoting &lt;em&gt;Todd v. Exxon Corp.&lt;/em&gt;, 275 F.3d 191, 198 (2d Cir. 2001), on information exchange as a &amp;ldquo;facilitating practice&amp;rdquo;).]] The court declined to require at the pleading stage allegations explaining how the algorithm worked to facilitate the alleged collusion. Nor did the hotels&amp;rsquo; ability to override recommendations defeat the claim because the alleged friction of &amp;ldquo;requiring a special override to be used only in times of &amp;lsquo;need and extreme circumstances,&amp;rsquo; and [] scoring each casino-hotel on how often it overrides the algorithm&amp;rsquo;s price and forecast recommendation&amp;rdquo; combined with the alleged approximately 90% adherence rate to recommended prices supported an inference of agreement.[[N: Op. at 23, 38 (quoting &lt;em&gt;United States v. Masonite Corp.&lt;/em&gt;, 316 U.S. 265, 276 (1942); the approximate 90% adherence rate and override friction support an inference of agreement).]]&lt;/p&gt;
&lt;p&gt;In conclusion, the Third Circuit distinguished the pricing algorithm from using &amp;ldquo;identical spreadsheets or pricing formulas&amp;rdquo; or even using software to set production levels because it allegedly involved &amp;ldquo;exchange of non-public commercial information&amp;rdquo; that was then used to provide price recommendations that were adopted most of the time.[[N: Op. at 40-41 (distinguishing amicus examples of independently used software offered by the International Center for Law &amp;amp; Economics).]] While the court acknowledged the potential pitfalls inherent in assessing the competitive impacts of new and shifting technologies, it ultimately concluded that &amp;ldquo;the goal of our antitrust jurisprudence remains the same: to ensure the continued existence of &amp;lsquo;independent centers of decision-making,&amp;rsquo;&amp;rdquo; and held that &amp;ldquo;[the software] is alleged to operate as a single decision-maker or hub, coordinating pricing for a majority of the market.&amp;rdquo;[[N: Op. at 41-42.]]&lt;/p&gt;
&lt;h2&gt;How &lt;em&gt;Cornish-Adebiyi&lt;/em&gt; Differs From &lt;em&gt;Gibson&lt;/em&gt;&lt;/h2&gt;
&lt;p&gt;Although both&lt;em&gt; Cornish-Adebiyi &lt;/em&gt;and &lt;em&gt;Gibson&lt;/em&gt; reached different results analyzing the same software, the two appellate decisions are largely reconcilable &amp;mdash; and the differences are instructive.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;First&lt;/strong&gt;, the theories on appeal diverged. In &lt;em&gt;Gibson&lt;/em&gt;, the plaintiffs abandoned their &amp;ldquo;hub-and-spoke&amp;rdquo; theory and pressed only the argument that the hotels&amp;rsquo; separate license agreements with a common vendor, in the aggregate, violated the antitrust laws. The Ninth Circuit rejected that theory, describing the license agreements as ordinary sales contracts that did not restrain any hotel&amp;rsquo;s ability to price independently. In &lt;em&gt;Cornish-Adebiyi&lt;/em&gt;, by contrast, the plaintiffs pursued the horizontal (hub-and-spoke) agreement theory and supported it with alleged parallel conduct and plus factors.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Second&lt;/strong&gt;, the allegations differed as to the sharing of non-public, competitively sensitive information. The &lt;em&gt;Gibson&lt;/em&gt; software was not alleged to pool, share, or otherwise use one hotel&amp;rsquo;s confidential information to inform prices for competitors, and the Ninth Circuit expressly signaled that its analysis may be different if the software allowed the sharing of confidential information among competitors.[[N: &lt;em&gt;Gibson v. Cendyn Group, LLC&lt;/em&gt;, 148 F.4th 1069, 1083 (9th Cir. 2025), cert. denied, 224 L. Ed. 2d 502 (Apr. 20, 2026) (&amp;ldquo;This analysis might change if Plaintiffs had alleged that Cendyn shared the confidential information of each competing hotel among the licensees.&amp;rdquo;).]] In &lt;em&gt;Cornish-Adebiyi&lt;/em&gt;, the Third Circuit found that the complaint alleges that the algorithm ingested each hotel&amp;rsquo;s non-public, real-time pricing and occupancy data and used that pooled data to inform price recommendations to competitors.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Third&lt;/strong&gt;, the &lt;em&gt;Cornish-Adebiyi&lt;/em&gt; complaint alleged facts sufficient to infer agreement because the hotels accepted the algorithm&amp;rsquo;s recommended rates roughly 90% of the time and could override them only in times of&amp;nbsp;&amp;ldquo;need and extreme circumstances.&amp;rdquo;[[N: Op. at 23 (quoting CAC &amp;para;&amp;para; 138-39).&amp;nbsp;]] By comparison, &lt;em&gt;Gibson&lt;/em&gt; found that the complaint in that case did not allege that the hotels were required to accept the software&amp;rsquo;s recommendations.&amp;nbsp; &amp;nbsp;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;In other words, rather than taking a conflicting approach, the Third Circuit relied on allegations that the Ninth Circuit found relevant but absent in &lt;em&gt;Gibson&lt;/em&gt;. The two decisions together confirm that allegations concerning (a) a horizontal agreement among competitors (a &amp;ldquo;rim&amp;rdquo;), (b) an exchange of non-public, competitively sensitive information, and (c) users&amp;rsquo; adherence to the software&amp;rsquo;s recommendations may be the difference between dismissal and proceeding to discovery.&lt;/p&gt;
&lt;h2&gt;Takeaways&lt;/h2&gt;
&lt;p&gt;&lt;em&gt;Cornish-Adebiyi&lt;/em&gt; reinforces the guideposts our &lt;a href="/en/perspectives/advisories/2025/08/antitrust-implications-of-algorithmic-pricing"&gt;August 2025 Advisory&lt;/a&gt;&amp;nbsp;drew from &lt;em&gt;Gibson&lt;/em&gt; and shows how these key issues can be outcome determinative. Companies evaluating algorithmic pricing tools should continue to ask:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Was the decision to use the software reached independently?&lt;/strong&gt; Communications or understandings with competitors about whether to use a tool, which tool to use, or how to use its outputs can supply the &amp;ldquo;rim&amp;rdquo; to an alleged antitrust conspiracy.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Does the tool incorporate non-public competitor data to make pricing recommendations?&lt;/strong&gt; The Third Circuit relied heavily on the allegation that the software pooled each hotel&amp;rsquo;s confidential, real-time, pricing or occupancy data, and used that data to inform pricing recommendations to competitors.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Does the software or the license agreement limit the user&amp;rsquo;s ability to set pricing?&lt;/strong&gt; The Third Circuit ruled that a high adherence rate and friction around overriding recommendations supported an inference of agreement, notwithstanding that each hotel retained nominal final pricing authority.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Does the software or license restrict the user&amp;rsquo;s ability to compete in some way?&lt;/strong&gt; Terms that limit independent pricing or the ability to use other vendors suggest potential for anticompetitive effects.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;As we cautioned after &lt;em&gt;Gibson&lt;/em&gt;, enforcers have urged courts to treat the common use of pricing algorithms as potentially unlawful, and different district courts continue to reach different results.[[N: See, e.g., Statement of Interest, &lt;em&gt;In re MultiPlan Health Ins. Provider Litig.&lt;/em&gt;, No. 1:24-cv-06795, ECF No. 382 (N.D. Ill. Mar. 27, 2025); Statement of Interest of the United States, &lt;em&gt;In re Frozen Potato Prods. Antitrust Litig.&lt;/em&gt;, No. 1:24-cv-11801, ECF No. 266 (N.D. Ill. Feb. 27, 2026). Compare &lt;em&gt;In re RealPage, Inc., Rental Software Antitrust Litig.&lt;/em&gt; (No. II), 709 F. Supp. 3d 478 (M.D. Tenn. 2023) (denying dismissal), and &lt;em&gt;Duffy v. Yardi Sys., Inc.&lt;/em&gt;, 758 F. Supp. 3d 1283 (W.D. Wash. 2024) (sustaining a per se claim), with &lt;em&gt;Gibson v. Cendyn Grp., LLC&lt;/em&gt;, 148 F.4th 1069 (9th Cir. 2025) (affirming dismissal), and &lt;em&gt;Segal v. Amadeus IT Grp.&lt;/em&gt;, S.A., No. 24-CV-1783, 2026 WL 879583 (N.D. Ill. Mar. 31, 2026) (dismissing).&amp;nbsp;]]&amp;nbsp;&lt;em&gt;Cornish-Adebiyi&lt;/em&gt; now provides appellate support for plaintiffs where the allegations include contemporaneous use of software among competitors, the exchange of non-public competitively sensitive information, and high adherence to the software&amp;rsquo;s recommendations. The decision resolves the case only at the pleading stage, however, and the plaintiffs will face a higher burden to support their claims with evidence as the case proceeds. Nevertheless, companies should treat the opinion as a clear signal that third-party pricing tools can create antitrust risk and engage antitrust counsel to evaluate pricing software before adoption.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{47C1794E-7F41-4177-82A4-6BA34C27A7DC}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/08/usda-proposes-major-overhaul-of-afida-rules-in-focus-on-the-expansion-of</link><a10:author><a10:name>Marisa N. Bocci</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bocci-marisa-n</a10:uri><a10:email>Marisa.Bocci@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jeffrey C. Thomson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomson-jeffrey-c</a10:uri><a10:email>jeff.thomson@arnoldporter.com</a10:email></a10:author><title>USDA Proposes Major Overhaul of AFIDA Rules: In Focus on the Expansion of “Any Interest” and Commercial Real Estate Implications</title><description>This Advisory is the third in our series on the proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) published by the U.S. Department of Agriculture (USDA) on June 25, 2026.&amp;nbsp;</description><pubDate>Mon, 03 Aug 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This Advisory is the third in our series on the proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) published by the U.S. Department of Agriculture (USDA) on June 25, 2026. Our &lt;a href="/en/perspectives/advisories/2026/06/usda-proposes-major-overhaul-of-afida-rules"&gt;June 2026 Advisory&lt;/a&gt;&amp;nbsp;provided a comprehensive overview of the proposed changes to the Agricultural Foreign Investment Disclosure Act (AFIDA) framework. Our &lt;a href="/en/perspectives/advisories/2026/07/usda-proposes-major-overhaul-of-afda-rules-in-focus-on-the-expansion-of-the"&gt;July 2026 Advisory&lt;/a&gt;&amp;nbsp;focused on the expanded &amp;ldquo;beneficial owner&amp;rdquo; definition and shift from a purely equity-based inquiry to a broader review of corporate governance and operational control as it related to foreign ownership disclosure. Here, we turn to an issue that may be of particular interest to commercial real estate practitioners: how the proposed rule&amp;rsquo;s expanded definition of &amp;ldquo;agricultural land&amp;rdquo; and its narrowed exemptions for leases and easements could bring a wider range of commercial real estate assets and transactions within AFIDA&amp;rsquo;s scope.&lt;/p&gt;
&lt;h2&gt;The Existing Framework: What Counts as &amp;ldquo;Agricultural Land&amp;rdquo; Today&lt;/h2&gt;
&lt;p&gt;Before examining the proposed changes, it is worth understanding the current landscape. Under 7 CFR 781.2(b), &amp;ldquo;agricultural land&amp;rdquo; includes all land currently used for, or if currently idle, land last used within the past five years for, farming, ranching, or timber production. The implementing regulations classify covered activities using 1987 Standard Industrial Classification (SIC) codes, primarily Division A (agriculture, forestry, and fishing).&lt;/p&gt;
&lt;p&gt;Three existing exemptions have historically kept many commercial real estate transactions outside AFIDA&amp;rsquo;s practical reach: (1) tracts of land not exceeding10 acres in the aggregate where annual gross receipts from agricultural activity do not exceed $1,000; (2) leaseholds of less than 10 years (inclusive of all options to renew or extend); and (3) easements and rights-of-way used for purposes unrelated to agricultural production. 7 CFR 781.2(b), (c).&lt;/p&gt;
&lt;p&gt;Notably, the existing definition already sweeps more broadly than many commercial practitioners realize. The five-year look-back period for idle land means that recently farmed parcels remain &amp;ldquo;agricultural land&amp;rdquo; regardless of current zoning or platting or future development plans. Additionally, the inclusion of forestry and timber production means that large tracts of timberland, whether actively managed or passively held, have always been subject to AFIDA. However, the reliance on outdated SIC codes, the de minimis acreage threshold, and the lease and easement exemptions have, until now, collectively shielded a significant volume of commercial real estate activity from filing obligations.&lt;/p&gt;
&lt;h2&gt;The Proposed Definition: What Changes&lt;/h2&gt;
&lt;p&gt;Proposed Section 5100.2(b) would expand the definition of &amp;ldquo;agricultural land,&amp;rdquo; and proposed Section 5100.2(c) would separately revise the definition of &amp;ldquo;any interest.&amp;rdquo; Taken together, these terms determine which property interests are reportable under AFIDA. Under the proposed rule, both definitions would change in several significant respects:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Replacement of SIC codes with 2022 NAICS codes&lt;/strong&gt;. The proposed rule would abandon the 1987 SIC classification system in favor of current North American Industry Classification System (NAICS) codes. This update alone broadens the scope of covered activities, because NAICS codes capture commercial categories that did not exist or were not separately classified in the 1987 SIC system.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Express inclusion of energy and infrastructure uses&lt;/strong&gt;. Through the incorporation of the 2022 NAICS codes, the proposed definition of &amp;ldquo;agricultural land&amp;rdquo; includes solar electric power generation (NAICS 221114), wind electric power generation (NAICS 221115), pipeline transportation (NAICS 486), agricultural research and development (NAICS 541714 and 541715), and support activities for agriculture and forestry (NAICS 115). Agricultural supply-chain operations, including farm product warehousing and storage, livestock wholesaling, and animal slaughtering and processing, as well as research and development activities in categories such as agriculture, botany, biology, fisheries, forests, veterinary science, and agricultural biotechnology are also included within the expanded definition of &amp;ldquo;agricultural land&amp;rdquo;.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Conservation land expressly captured&lt;/strong&gt;. Land that &amp;ldquo;could be used&amp;rdquo; for farming, ranching, forestry, or timber production &amp;ldquo;despite its conservation designation or under the terms of its conservation designation&amp;rdquo; would be classified as agricultural land and subject to disclosure under AFIDA. This classification captures Conservation Reserve Program (CRP) enrollments, Agricultural Conservation Easement Program (ACEP) holdings, and similar arrangements.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Elimination of the de minimis exemption&lt;/strong&gt;. The current exemption for tracts of land that do not exceed 10 acres with less than $1,000 of annual agricultural production would be removed entirely.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Lease exemption narrowed&lt;/strong&gt;. The exemption for leases of less than 10 years would be reduced to leases of less than one year (measuring the aggregate of multiple leases over a continuous or discontinuous period). For foreign adversaries and Foreign Adversary Controlled Entities, the exemption is entirely eliminated.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Easement and right-of-way exemption removed&lt;/strong&gt;. The current exemption for easements &amp;ldquo;used for purposes unrelated to agricultural production&amp;rdquo; would be deleted in its entirety. Any easement or right-of-way across land meeting the agricultural land definition would become reportable under AFIDA. Together with the narrowed lease exemption, these changes substantially broaden the property interests subject to AFIDA reporting.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Remaining exclusions unchanged&lt;/strong&gt;. The proposed rule leaves undisturbed the other categorical exclusions from AFIDA: security interests, contingent future interests, and interests held solely in mineral rights all continue to fall outside AFIDA&amp;rsquo;s reporting obligations.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Zoning irrelevance&lt;/strong&gt;. While the existing USDA guidelines note that zoning designations are not dispositive, the proposed rule clarifies that land meeting the definition of &amp;ldquo;agricultural land&amp;rdquo; is agricultural &amp;ldquo;regardless of local government zoning classifications.&amp;rdquo; Thus, rezoning alone does not remove otherwise reportable land from the bounds of AFIDA.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Five Scenarios: How Commercial Real Estate Is Affected&lt;/h2&gt;
&lt;p&gt;The following scenarios illustrate how the proposed rule changes could affect common commercial real estate transaction types.&lt;/p&gt;
&lt;h3&gt;Scenario 1: Developers Acquiring Agricultural Land for Commercial Purposes&lt;/h3&gt;
&lt;p&gt;Context: A commercial developer acquires a 500-acre parcel on the urban fringe that was used for row-crop farming until two years ago. The parcel has been rezoned for mixed-use development and no farming is occurring at closing.&lt;/p&gt;
&lt;p&gt;Current rule: The five-year look-back already applies, so the land is &amp;ldquo;agricultural land&amp;rdquo; under the existing definition. If the developer is a &amp;ldquo;foreign person&amp;rdquo; under the current 50%-aggregate threshold, an FSA-153 filing is required within 90 days.&lt;/p&gt;
&lt;p&gt;Proposed rule: The same five-year look-back applies (this is not new). However, the proposed rule has three changes that will bring more commercial projects into the AFIDA orbit: (a) the &amp;ldquo;regardless of local zoning&amp;rdquo; clarification removes any argument that rezoning takes land out of the definition; (b) the de minimis exemption is eliminated, so even small parcels are covered; and (c) the lowered 10%-aggregate threshold (down from 50%) means significantly more developers will be &amp;ldquo;foreign persons.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Example: A European-headquartered development fund acquires a rezoned 200-acre site outside a Sunbelt metro area. The site was in active cotton production until 18 months before closing. The fund is organized as a Delaware LLC, but a consortium of European pension funds holds 35% of the equity. Under current law, the 50%-non-concert threshold means the fund is not a &amp;ldquo;foreign person.&amp;rdquo; Under the proposed rule, the 10%-aggregate threshold is met, the fund is a &amp;ldquo;foreign person,&amp;rdquo; and the land is &amp;ldquo;agricultural&amp;rdquo; regardless of zoning. Filing is required within 90 days.&lt;/p&gt;
&lt;p&gt;Practical notes: Developers should conduct agricultural-use due diligence on rural and path-of-growth parcels, including checking USDA records, county assessor classifications, and actual use within the prior five years, even when the land is zoned for non-agricultural uses.&lt;/p&gt;
&lt;h3&gt;Scenario 2: Easements and Rights-of-Way Through Agricultural Land&lt;/h3&gt;
&lt;p&gt;Context: A utility company acquires pipeline or transmission easements across hundreds of miles of farmland, a commercial developer acquires a 30-foot-wide access easement across a neighboring farm to reach a development parcel, or a foreign person acquires an easement across a neighbor&amp;rsquo;s timberland tract to access a personal residence.&lt;/p&gt;
&lt;p&gt;Current rule: Easements and rights-of-way &amp;ldquo;used for purposes unrelated to agricultural production&amp;rdquo; are expressly exempt from the definition of &amp;ldquo;any interest.&amp;rdquo; The access easement and utility easement both qualify for this exemption.&lt;/p&gt;
&lt;p&gt;Proposed rule: The easement exemption would be removed. Any easement or right-of-way across land meeting the &amp;ldquo;agricultural land&amp;rdquo; definition would be a reportable interest.&lt;/p&gt;
&lt;p&gt;Example: A foreign-owned pipeline company holds transmission easements across 2,000 parcels of farmland in 15 states. Under current law, none of these easements are reportable. Under the proposed rule, each easement across land meeting the agricultural-land definition would be a separately reportable interest. Because the NAICS definition now includes pipeline transportation (NAICS 486), both the land and the interest are captured.&lt;/p&gt;
&lt;p&gt;Practical notes: Linear infrastructure operators should inventory existing easement portfolios for AFIDA exposure. The transition window for filing on newly reportable holdings (90 days from the final rule&amp;rsquo;s effective date) may be insufficient to inventory thousands of easements across multiple states.&lt;/p&gt;
&lt;h3&gt;Scenario 3: Timberland, Conservation Holdings, and Buffer Land&lt;/h3&gt;
&lt;p&gt;Context: A utility or infrastructure company holds timberland as a buffer around a manufacturing facility, or an investor holds land enrolled in a USDA conservation program such as CRP or ACEP.&lt;/p&gt;
&lt;p&gt;Current rule: Timberland already qualifies as agricultural land. Conservation land is less clear; if the land has not been used for farming or timber in the past five years, it may fall outside the existing definition.
&lt;/p&gt;
&lt;p&gt;Proposed rule: Conservation land is now expressly included if it &amp;ldquo;could be used for farming, ranching, forestry, or timber production despite its conservation designation or under the terms of its conservation designation.&amp;rdquo; The de minimis exemption is eliminated.&lt;/p&gt;
&lt;p&gt;Example: A foreign sovereign wealth fund holds a portfolio of 50,000 acres of timberland surrounding a manufacturing complex. The timberland is already reportable. But 8,000 acres of adjacent conservation land enrolled in CRP were previously outside the definition. Under the proposed rule, the conservation acreage is now &amp;ldquo;agricultural land,&amp;rdquo; and the fund must file on those parcels as well.&lt;/p&gt;
&lt;p&gt;Practical notes: Conservation enrollment does not remove land from AFIDA. Filers must also keep the land-use breakdown current on the new geospatial map; moving acreage from cropland to conservation is a reportable use change under proposed Section 5100.3(j).&lt;/p&gt;
&lt;h3&gt;Scenario 4: Renewable Energy and Data Centers on Rural Land&lt;/h3&gt;
&lt;p&gt;Context: A solar or wind developer leases 5,000 acres of farmland under a 30-year site-control lease. A data center developer acquires a 300-acre site that was in active crop production until three years ago.&lt;/p&gt;
&lt;p&gt;Current rule: The lease is reportable if 10 years or longer and the lessee is a &amp;ldquo;foreign person.&amp;rdquo; However, solar and wind generation are not covered by the existing SIC codes so if the original solar or wind developer is mid-stream on its project and has converted the land out of agricultural land, and thereafter assigns the lease to a new foreign person, the new assignee would not have an obligation to file (note, however, that the original lessee would have triggered a filing obligation upon the disposition of its interest). For the data center, the five-year look-back applies, but data center development is not itself a covered activity.&lt;/p&gt;
&lt;p&gt;Proposed rule: Solar electric power generation (NAICS 221114) and wind electric power generation (NAICS 221115) are now expressly included as part of the definition of &amp;ldquo;agricultural land,&amp;rdquo; so the subsequent acquisition of operating projects that were not previously reportable by the assignee would not become reportable. The lease exemption narrows from under 10 years to under one year; the vast majority of renewable leases will be reportable under this revised framework. The USDA preamble notes that it is &amp;ldquo;aware that agricultural land is often leased to develop or explore the potential development of land for particular purposes, including energy projects&amp;rdquo; and specifically requests comment on how to calculate fair market value for such leases. (91 Fed. Reg. at 38319.)&lt;/p&gt;
&lt;p&gt;Example: A Danish renewable energy company holds renewable leases on 20,000 acres of cropland across the Midwest for a portfolio of wind projects. The leases are structured such that the lease commences as of the execution date (and not a later exercise of an option thereunder) and continue through the decommissioning period a total of 45 years. Under current law, the company files on the leases (10-plus years). Under the proposed rule, wind electric power generation is itself a covered NAICS code. Accordingly, any subsequent transfers of the leasehold interest would also be subject to filing obligations for not just the original lessee, but also any subsequent foreign persons, regardless of what stage the wind project is in for its development, so long as one year or more remains on the lease. The company should inventory all lease interests, including short-term options and extensions, for new filing exposure.&lt;/p&gt;
&lt;p&gt;Practical notes: Renewable energy developers that are already AFIDA filers should review whether the expanded definition captures additional interests or parcels. Developers structuring new leases or other site control arrangements should consider how the one-year lease threshold and the inclusion of solar and wind NAICS codes affect phased development timelines.&lt;/p&gt;
&lt;h3&gt;Scenario 5: Path-of-Growth Portfolios and Pre-Development Holdings&lt;/h3&gt;
&lt;p&gt;Context: A developer or institutional investor acquires and holds parcels of farmland in anticipation of future rezoning and development, leasing the land to local farmers in the interim.&lt;/p&gt;
&lt;p&gt;Current rule: The land is &amp;ldquo;agricultural land&amp;rdquo; while being farmed (and for five years after farming ceases). The lease exemption (under 10 years) shields farm leases from creating independent filing obligations for foreign tenants.&lt;/p&gt;
&lt;p&gt;Proposed rule: (a) The zoning-irrelevance rule means that rezoning the parcel during the hold period does not remove it from the definition; (b) the lease exemption narrows to under one year, so a three-year farm lease to a foreign tenant now triggers the tenant&amp;rsquo;s independent filing obligation; (c) the lowered 10%-aggregate threshold means the developer is more likely to be a &amp;ldquo;foreign person&amp;rdquo;; and (d) the ongoing obligation to update the geospatial map and land-use breakdown means that changes in how the land is farmed (rotating crops, enrolling acreage in conservation) must be reported.&lt;/p&gt;
&lt;p&gt;Example: A U.S. real estate fund with 12%-aggregate foreign LP ownership holds 15,000 acres of Midwestern cropland as a path-of-growth portfolio, leasing the land to local farmers under rolling three-year leases. Under current law, the fund is not a &amp;ldquo;foreign person&amp;rdquo; (50%-non-concert threshold not met; three-year leases are exempt). Under the proposed rule, the fund is a &amp;ldquo;foreign person&amp;rdquo; (10%-aggregate threshold met), the three-year farm leases are reportable (over one year), and any foreign tenant-farmers also have independent filing obligations.&lt;/p&gt;
&lt;p&gt;Practical notes: Developers holding path-of-growth portfolios should: (1) map upstream foreign ownership to assess whether the 10%-aggregate threshold is met; (2) review lease arrangements with tenant-farmers for potential tenant filing obligations; and (3) establish a monitoring process for land-use changes that trigger update filings. Consider adding AFIDA representation and notice covenants to farm leases.&lt;/p&gt;
&lt;h2&gt;Key Takeaways for Commercial Real Estate Practitioners&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Developers&lt;/strong&gt;: Conduct agricultural-use due diligence on all rural and transitional land acquisitions, even when the land is rezoned. The five-year look-back and zoning-irrelevance rule can surprise.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Infrastructure and pipeline companies&lt;/strong&gt;: Inventory existing easement and right-of-way portfolios for newly reportable interests. Consider the 90-day transition window.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Renewable energy developers&lt;/strong&gt;: Solar, wind, and pipeline NAICS codes are now expressly covered. Review all site-control leases, including short-term options, for filing exposure under the narrowed lease exemption.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Asset managers and fund sponsors&lt;/strong&gt;: Map upstream foreign ownership. The 10%-aggregate threshold (down from 50%) and the beneficial-owner trigger (control-based, no equity floor) mean more vehicles will be &amp;ldquo;foreign persons.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Landlords with foreign tenants&lt;/strong&gt;: A foreign tenant&amp;rsquo;s lease of one year or more now triggers the tenant&amp;rsquo;s independent filing obligation. Consider AFIDA representations and notice covenants in leases.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Final Points&lt;/h2&gt;
&lt;p&gt;In addition to the expanded AFIDA disclosure requirements, it is worth noting two important points. First, AFIDA filing obligations are often used as a trigger for separate filing obligations under state analogous statutes. Accordingly, a broader filing pool under AFIDA will result in a broader filing pool under many state reporting regimes. Furthermore, many of these state regimes also include their own prohibitions, acreage limitations, or other use restrictions. And, second, while not currently in effect, there are federal legislative proposals to align the administration of AFIDA with the Committee on Foreign Investment in the United States&amp;rsquo; national security mission.[[N:&amp;nbsp;This Advisory draws on the proposed rule and the following primary sources: 91 Fed. Reg. 38315 (June 25, 2026); proposed Sections 5100.2(b), (c), (p); 5100.3(b), (e), (j); 5100.4(b)(3); 7 CFR 781.2(b), (c), (k); USDA National Farm Security Action Plan (July 2025); GAO-24-106337 (Jan. 2024).]]&lt;/p&gt;
&lt;p&gt;The comment period on the proposed rule closes on August 10, 2026. We are continuing to monitor developments and can assist with assessing exposure, structuring analysis, and preparing public comments.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{B15F28B0-D158-4772-B373-59EBE6E4373A}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/managing-ip-recognizes-arnold-porter-in-2026-ip-stars-americas-rankings</link><title>Managing IP Recognizes Arnold &amp; Porter in 2026 IP Stars Americas Rankings</title><description>&lt;em&gt;Managing IP&lt;/em&gt; recognized 18 Arnold &amp;amp; Porter lawyers as IP Stars and Rising Stars in its 2026 IP Stars Americas rankings. The guide also recognized 17 Arnold &amp;amp; Porter practice areas across multiple U.S. regions for their intellectual property capabilities. IP STARS is an annual guide that identifies leading intellectual property practitioners and firms based on peer and client feedback, evaluating factors such as expertise, workload, and outcomes achieved for clients.</description><pubDate>Fri, 31 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;em&gt;Managing IP&lt;/em&gt; recognized 18 Arnold &amp;amp; Porter lawyers as IP Stars and Rising Stars in its 2026 IP Stars Americas rankings. The guide also recognized 17 Arnold &amp;amp; Porter practice areas across multiple U.S. regions for their intellectual property capabilities. IP Stars is an annual guide that identifies leading intellectual property practitioners and firms based on peer and client feedback, evaluating factors such as expertise, workload, and outcomes achieved for clients.&lt;/p&gt;
&lt;p&gt;The following Arnold &amp;amp; Porter lawyers were recognized by &lt;em&gt;Managing IP&lt;/em&gt;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;David Benyacar&amp;mdash;Patent Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Daniel DiNapoli&amp;mdash;Patent Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Deborah Fishman&amp;mdash;Patent Star (United States National; California)&lt;/li&gt;
    &lt;li&gt;Patrick Hall&amp;mdash;Rising Star (United States National; Colorado)&lt;/li&gt;
    &lt;li&gt;Dori Hanswirth&amp;mdash;Copyright Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Michael Harris&amp;mdash;Patent Star (United States National; Illinois)&lt;/li&gt;
    &lt;li&gt;Ronald Johnston&amp;mdash;Trademark Star; Copyright Star (United States National; California)&lt;/li&gt;
    &lt;li&gt;Paul Llewellyn&amp;mdash;Trademark Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Thomas Magnani&amp;mdash;Transactions Star (United States National; California)&lt;/li&gt;
    &lt;li&gt;David Marsh&amp;mdash;Patent Star (United States National; District of Columbia)&lt;/li&gt;
    &lt;li&gt;Oscar Ramallo&amp;mdash;Rising Star (United States National; California)&lt;/li&gt;
    &lt;li&gt;Daniel Reisner&amp;mdash;Patent Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Christopher Renk&amp;mdash;Patent Star; Trademark Star (United States National; Illinois)&lt;/li&gt;
    &lt;li&gt;Evan Rothstein&amp;mdash;Patent Star (United States National; Colorado)&lt;/li&gt;
    &lt;li&gt;Matthew Salzmann&amp;mdash;Trademark Star (United States National; New York)&lt;/li&gt;
    &lt;li&gt;Rhonda Trotter&amp;mdash;Trademark Star; Copyright Star (United States National; California)&lt;/li&gt;
    &lt;li&gt;Pallavi Mehta Wahi&amp;mdash;Trademark Star (United States National; Washington)&lt;/li&gt;
    &lt;li&gt;Matthew Wolf&amp;mdash;Patent Star (United States National; District of Columbia)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The annual guide also recognized Arnold &amp;amp; Porter in the following practice areas:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Copyright &amp;amp; Related Rights (United States National)&lt;/li&gt;
    &lt;li&gt;Federal Circuit (United States National)&lt;/li&gt;
    &lt;li&gt;IP Transactions (United States National)&lt;/li&gt;
    &lt;li&gt;Life Sciences &amp;ndash; IP (United States National)&lt;/li&gt;
    &lt;li&gt;Patent Disputes (United States National)&lt;/li&gt;
    &lt;li&gt;Trademark Disputes (United States National)&lt;/li&gt;
    &lt;li&gt;Trademark Prosecution (United States National)&lt;/li&gt;
    &lt;li&gt;Copyright &amp;amp; Related Rights (California)&lt;/li&gt;
    &lt;li&gt;Patent Disputes (California)&lt;/li&gt;
    &lt;li&gt;Trademark Disputes (California)&lt;/li&gt;
    &lt;li&gt;Copyright &amp;amp; Related Rights (District of Columbia)&lt;/li&gt;
    &lt;li&gt;Patent Disputes (District of Columbia)&lt;/li&gt;
    &lt;li&gt;Patent Prosecution (District of Columbia)&lt;/li&gt;
    &lt;li&gt;Trademark Disputes (District of Columbia)&lt;/li&gt;
    &lt;li&gt;Copyright &amp;amp; Related Rights (New York)&lt;/li&gt;
    &lt;li&gt;Patent Disputes (New York)&lt;/li&gt;
    &lt;li&gt;Trademark Disputes (New York)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Earlier this year, &lt;em&gt;Managing IP&lt;/em&gt; recognized Arnold &amp;amp; Porter in its &lt;a href="https://www.arnoldporter.com/en/perspectives/news/2026/06/managing-ip-names-four-arnold-porter-lawyers-as-western-europe-ip-stars"&gt;2026 IP Stars Western Europe rankings&lt;/a&gt;, recognizing the firm&amp;rsquo;s IP Transactions practice and four lawyers for their individual achievements.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8CE0E331-9E41-4B8A-AD03-EB060D3E7F12}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/latin-lawyer-recognizes-arnold-porter-finance-lawyers-in-2025-deal-tracker</link><title>Latin Lawyer  Recognizes Arnold &amp; Porter Finance Lawyers in 2025 Deal Tracker</title><description>Arnold &amp;amp; Porter partner Gregory Harrington, counsel Arturo Caraballo, and senior associates Valentina Garzon and Mateo Morris Lievano have been recognized in &lt;em&gt;Latin Lawyer's &lt;/em&gt;2025 Deal Tracker, which provides an annual ranking of the most active international lawyers advising on financing transactions across Latin America. The lawyers were named in the Debt Capital Markets and Banking &amp;amp; Finance categories. Greg Harrington was one of only six international lawyers recognized across both the Debt Capital Markets and Banking &amp;amp; Finance categories.</description><pubDate>Fri, 31 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Gregory Harrington, counsel Arturo Caraballo, and senior associates Valentina Garzon and Mateo Morris Lievano have been recognized in &lt;em&gt;Latin Lawyer&amp;rsquo;s&lt;/em&gt; 2025 Deal Tracker, which provides an annual ranking of the most active international lawyers advising on financing transactions across Latin America. The lawyers were named in the Debt Capital Markets and Banking &amp;amp; Finance categories. Greg Harrington was one of only six international lawyers recognized across both the Debt Capital Markets and Banking &amp;amp; Finance categories.&lt;/p&gt;
&lt;p&gt;The following Arnold &amp;amp; Porter lawyers were recognized among the most active international lawyers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Gregory Harrington&amp;mdash;Debt Capital Markets and Banking &amp;amp; Finance&lt;/li&gt;
    &lt;li&gt;Arturo Caraballo&amp;mdash;Banking &amp;amp; Finance&lt;/li&gt;
    &lt;li&gt;Valentina Garzon&amp;mdash;Debt Capital Markets&lt;/li&gt;
    &lt;li&gt;Mateo Morris Lievano&amp;mdash;Banking &amp;amp; Finance&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Together, these recognitions reflect Arnold &amp;amp; Porter&amp;rsquo;s strength advising sovereign, state-owned, and corporate clients on sophisticated financing transactions throughout Latin America. Based on transactions reported to &lt;em&gt;Latin Lawyer&lt;/em&gt;, the Deal Tracker rankings recognize the firm&amp;rsquo;s work across the principal forms of international financing, including bond offerings, syndicated loans, liability management transactions, and other capital markets and banking and finance matters.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{98CFAD99-CF1E-43C7-91C9-62FDF7D1E0A3}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/debbie-feinstein-discusses-state-ag-enforcement-and-antitrust-trends-in-legal-business</link><title>Debbie Feinstein Discusses State AG Enforcement and Antitrust Trends in Legal Business</title><description>Debbie Feinstein, Arnold &amp;amp; Porter Antitrust/Competition partner and former Bureau of Competition Director at the U.S. Federal Trade Commission (FTC), was quoted in the &lt;em&gt;Legal Business&lt;/em&gt; article, &amp;ldquo;Open for Business: Top Antitrust Lawyers on Getting Deals Done in Trump's Second Term,&amp;rdquo; which examines how merger enforcement is evolving under the current administration.</description><pubDate>Fri, 31 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Debbie Feinstein, Arnold &amp;amp; Porter Antitrust/Competition partner and former Bureau of Competition Director at the U.S. Federal Trade Commission (FTC), was quoted in the &lt;em&gt;Legal Business&lt;/em&gt; article, &amp;ldquo;Open for Business: Top Antitrust Lawyers on Getting Deals Done in Trump's Second Term,&amp;rdquo; which examines how merger enforcement is evolving under the current administration.&lt;/p&gt;
&lt;p&gt;Discussing the growing role of state attorneys general in merger review, Debbie noted that states are increasingly willing to investigate transactions that federal enforcers decline to challenge. "We are beginning to see the states jump into things. I'm hearing that they are investigating deals where the DOJ took a pass," she observed. She further explained that, while political considerations are playing a greater role in merger enforcement, companies should maintain perspective. "That doesn't mean that on every deal you need to hire a lobbyist and they'll magically make it go away, but I can't say that lobbyists are totally irrelevant either."
&lt;/p&gt;
&lt;p&gt;Debbie also discusses the ongoing antitrust scrutiny of pharmaceutical transactions, explaining that the sector receives heightened attention largely due to the volume of deals and its innovation-driven business model. She noted that acquisitions of emerging biotechnology companies are "a very normal part of the ecosystem," reflecting the central role mergers play in advancing drug development.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.legalbusiness.co.uk/law-firms/open-for-business-top-antitrust-lawyers-on-getting-deals-done-in-trumps-second-term/"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{5D9A9985-AEEA-441E-B2D6-8484FC3D9933}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/07/virtual-digital-health-digest</link><a10:author><a10:name>Allison W. Shuren</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shuren-allison-w</a10:uri><a10:email>allison.shuren@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abeba Habtemariam</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/habtemariam-abeba</a10:uri><a10:email>Abeba.Habtemariam@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nancy L. Perkins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/perkins-nancy-l</a10:uri><a10:email>nancy.perkins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Monique Nolan, M.D., J.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nolan-monique</a10:uri><a10:email>monique.nolan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Casey Brouhard</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brouhard-casey</a10:uri><a10:email>casey.brouhard@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jacqueline L. Degann</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/degann-jacqueline</a10:uri><a10:email>jackie.degann@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katherine Rohde</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rohde-katherine</a10:uri><a10:email>kate.rohde@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brianna Morigney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/morigney-brianna</a10:uri><a10:email>brianna.morigney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lily Cao</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cao-lily</a10:uri><a10:email>lily.cao@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mickayla A. Stogsdill</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/stogsdill-mickayla</a10:uri><a10:email>mickayla.stogsdill@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Caroline Oliver</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/oliver-caroline</a10:uri><a10:email>caroline.oliver@arnoldporter.com</a10:email></a10:author><title>Virtual &amp; Digital Health Digest</title><description>This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2026 from the United States, United Kingdom, and European Union.</description><pubDate>Fri, 31 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2026 from the United States, United Kingdom, and European Union.&lt;/p&gt;
&lt;h2&gt;In this issue, you will find the following:&lt;/h2&gt;
&lt;h3&gt;U.S. News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Health Care Fraud And Abuse Updates"&gt;Health Care Fraud and Abuse Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy and AI Updates"&gt;Privacy and Artificial Intelligence (AI) Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Provider Reimbursement"&gt;Provider Reimbursement&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;U.S. Featured Content &lt;/h3&gt;
&lt;p&gt;This month&amp;rsquo;s edition highlights a sweeping range of developments across health care fraud enforcement, artificial intelligence (AI) regulation, and federal health policy. On the enforcement front, the U.S. Department of Justice&amp;rsquo;s (DOJ) 2026 National Health Care Fraud Takedown charged 455 defendants in connection with over $6.5 billion in alleged fraud, with several cases spotlighting the growing role of telemedicine and digitally enabled schemes in Medicare abuse. A licensed nurse practitioner and telemedicine company owner was also sentenced to 10 years in prison for her role in a $136 million Medicare fraud scheme. In the regulatory space, the Federal Trade Commission (FTC) released a proposed policy statement expressing concern that AI developers may be training models to suppress accuracy, with a public comment period open through July 31, 2026. On Capitol Hill, bipartisan legislation was introduced to accelerate AI-driven solutions for pediatric cancer, while the House Appropriations Committee advanced its Fiscal Year (FY) 2027 spending bill, which notably includes a prohibition on Centers for Medicare &amp;amp; Medicaid Services (CMS) funding for the AI-powered WISeR prior authorization model. Meanwhile, CMS established a new Office of Health Technology and Products to lead AI strategy across its programs, and the FDA issued a warning letter over unauthorized software changes to a patient monitoring device, sought public input on non-device software functions, and announced a public meeting on medical device user fee reauthorization with a focus on strengthening digital health oversight. CMS also released two Medicare payment proposed rules that would set 2027 rates for physicians and hospital outpatient departments and address several virtual and digital health policies.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;EU and UK News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Pricing and Reimbursement Updates"&gt;Pricing and Reimbursement Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;EU/UK Featured Content &lt;/h3&gt;
&lt;p&gt;AI continues to be at the top of the agenda for regulators in Europe. The European Commission (EC) has been focused on preparing for the majority of the provisions in the AI Act to come into force this August. Among those provisions are the transparency requirements, and to assist organizations with compliance, the EC has published a voluntary Code of Practice on the marking and labeling of AI-generated content. Further, a Scientific Panel and an Advisory Forum have been appointed to advise the EC&amp;rsquo;s AI Office and national competent authorities on implementation and enforcement of the AI Act.&lt;/p&gt;
&lt;p&gt;In the UK, we are seeing a continued commitment to regulating AI through guidance and codes of practice, as well as the provision of regulatory support through sandbox programs. The Information Commissioner&amp;rsquo;s Office (ICO), the data protection regulator, has published its plan for upcoming work in relation to AI, which sets out various plans for guidance and codes of practice. The Medicines and Healthcare products Regulatory Agency (MHRA) continues its focus on regulatory sandboxes and recently reported the outcome of the second phase of the AI Airlock. It has also announced further AI sandboxes in order to accelerate the development of medicines and to allow innovators to test AI tools that have the potential to predict how medicines behave in the body, and another, which will be London-focused.&lt;/p&gt;
&lt;p&gt;The key legislative development this month is that the EU Council has adopted its position on the first part of the Biotech Act, which, together with the European Commission&amp;rsquo;s draft, will form the basis of the trilogue discussions between the European Union (EU) institutions, hopefully leading to agreement on a finalized text.&amp;nbsp;
&lt;/p&gt;
&lt;h2&gt;U.S. News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Health Care Fraud And Abuse Updates"&gt;Health Care Fraud And Abuse Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-455-defendants-charged-connection-over-65" target="_blank"&gt;National Health Care Fraud Takedown Results in 455 Defendants Charged in Connection With Over $6.5 Billion in Alleged Fraud&lt;/a&gt;&lt;/strong&gt;.&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-455-defendants-charged-connection-over-65" target="_blank"&gt;&lt;/a&gt;&lt;/strong&gt;On June 23, 2026, the DOJ announced its 2026 National Health Care Fraud Takedown, charging 455 defendants, including 90 physicians and other licensed medical professionals, in connection with more than $6.5 billion in alleged false claims across 56 federal districts and 45 states and territories. Several of the matters involved telemedicine and digitally enabled schemes.&lt;/p&gt;
&lt;p&gt;The DOJ highlighted the arrest of Herb Kimble in connection with a previously charged $1.2 billion telemedicine and durable medical equipment (DME) scheme.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Additionally, the takedown included charges against Anthony Tursi for conspiracy to commit health care fraud and conspiracy to pay and receive health care kickbacks in connection with a $62 million scheme to bill Medicare for medically unnecessary genetic testing. Tursi allegedly owned a call center that ran deceptive telemarketing campaigns to persuade Medicare beneficiaries to agree to genetic tests and then sent faxes containing false and misleading representations to the beneficiaries&amp;rsquo; physicians to induce them into signing orders for the tests.&lt;/p&gt;
&lt;p&gt;On June 23, 2026, as part of the takedown, Bhamin Chhatrapati of Massachusetts was charged with conspiracy to commit health care fraud in connection with more than $5.1 million fraudulently billed to Medicare for DME. From approximately February 2023 through September 2024, Chhatrapati and his co-conspirators allegedly worked with telemarketers and call centers to obtain Medicare beneficiaries&amp;rsquo; information and used it to generate documentation making it appear that practitioners had legitimately prescribed medically necessary DME. The defendants allegedly paid the telemarketers per-brace order approved by Medicare, which paid over $2.6 million on the fraudulent claims.&lt;/p&gt;
&lt;p&gt;Also on June 23, 2026, as part of the takedown, the U.S. Attorney&amp;rsquo;s Office for the Northern District of New York announced that Aptihealth Inc. and Aptihealth Medical, PLLC, a telehealth behavioral health provider, agreed to pay $300,000 to resolve civil allegations under the False Claims Act. The government alleged that Aptihealth billed Medicare and Medicaid for services that were not rendered or not supported by adequate documentation, improperly billed administrative tasks as reimbursable medical services, offered gift cards to induce recipients to receive services, and failed to maintain an effective compliance program as required by New York law.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;The takedown resulted in the CMS suspending 1,079 providers and revoking billing privileges for 1,403 providers.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/telemedicine-company-owner-and-author-health-care-compliance-books-sentenced-136m-medicare" target="_blank"&gt;Telemedicine Company Owner and Author of Health Care Compliance Books Sentenced for $136 Million Medicare Fraud Scheme&lt;/a&gt;&lt;/strong&gt;. On June 30, 2026, Jean Wilson, a licensed nurse practitioner who owned and operated two telemedicine companies, was sentenced to 120 months in prison and ordered to pay $66 million in restitution for her role in a scheme to bill Medicare for medically unnecessary DME and prescription drugs.&lt;/p&gt;
&lt;p&gt;According to court documents, between 2017 and 2019, Wilson and others allegedly paid illegal kickbacks to providers to sign orders for orthotic braces and drug prescriptions for Medicare beneficiaries who did not need them and then sold the signed orders and prescriptions to purported marketing companies. Those marketers allegedly resold the orders to brace suppliers and pharmacies that billed the program. Wilson allegedly used shell accounts and nominee owners to conceal the conduct. In total, the scheme submitted over $136 million in false claims, of which Medicare paid more than $66 million.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy and AI Updates"&gt;Privacy and AI Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;Federal Trade Commission Solicits Comments on Proposed Policy Statement on AI Accuracy&lt;/strong&gt;. On July 1, 2026, the FTC released a proposed Policy Statement regarding its concerns that AI developers may be training their products to &amp;ldquo;suppress accuracy&amp;rdquo; such as &amp;ldquo;by training a model surreptitiously to produce ideologically motivated distortions in a response to a factual question.&amp;rdquo; The proposed statement emphasizes that consumers have come to rely on AI to assist them in making important decisions, including health-related choices, and notes that the FTC recently invoked its authority to address an AI company&amp;rsquo;s allegedly misleading claims that its AI tool could effectively replace human customer service representatives. The proposed policy statement will be published in the Federal Register. The public will have until July 31, 2026 to &lt;a rel="noopener noreferrer" href="https://www.regulations.gov/docket/FTC-2026-0859" target="_blank"&gt;submit comments&lt;/a&gt; on the policy statement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;New Federal Bill Would Support AI Use in Pediatric Health Care&lt;/strong&gt;. On July 9, 2026, House members Michael McCaul (R-TX), together with Ami Bera (D-CA) and Mike Kelly (R-PA), all of whom are Co-Chairs of the Congressional Childhood Cancer Caucus, introduced the &lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/9632/text?s=1&amp;amp;r=1" target="_blank"&gt;Accelerating Innovation for Kids with Cancer Act&lt;/a&gt; (HR 9632) as a means to encourage the use of AI for the development of cures for pediatric cancer. If enacted, the bill would require the president to appoint an individual or organization as a federal Coordinator of AI innovation, with the charge of identifying opportunities to accelerate the advancement of AI-driven solutions at the National Institutes of Health&amp;rsquo;s Cancer Institute&amp;rsquo;s Childhood Cancer Data Initiative (CCDI). The bill refers to several specific potential AI-driven measures for this purpose, including improving clinical trial design and access; making data platforms and AI tools available as part of the CCDI data ecosystem; and improving data infrastructure by consolidating data from multiple sources for AI-ready analysis and using AI to help select clinical trial subjects. The bill would require the U.S. Department of Health and Human Services (HHS) to establish interoperability standards for processing patient data with AI that provide for &amp;ldquo;safe and privacy-compliant&amp;rdquo; exchanges of data. The bill has been referred to the House Energy and Commerce Committee for further action.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;a name="Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;House Appropriations Committee Approves FY27 Labor, Health and Human Services, Education, and Related Agencies Appropriations Bill&lt;/strong&gt;. On June 9, 2026, the House Appropriations Committee &lt;a rel="noopener noreferrer" href="https://appropriations.house.gov/schedule/markups/full-committee-markup-fiscal-year-2027-labor-health-and-human-services-education-0" target="_blank"&gt;held&lt;/a&gt; a Full Committee Markup of the FY27 &lt;a rel="noopener noreferrer" href="https://www.congress.gov/119/bills/hr9260/BILLS-119hr9260rh.pdf" target="_blank"&gt;Labor, Health and Human Services, Education, and Related Agencies (L-HHS) bill&lt;/a&gt;. The committee favorably reported the FY27 L-HHS appropriations bill to the House by a party-line vote of 34-28. The committee recommends $110.8 billion in discretionary budget authority for HHS, which would be a reduction of $4 billion from the FY26-enacted level.&lt;/p&gt;
&lt;p&gt;Notably, the committee adopted a &lt;a rel="noopener noreferrer" href="https://appropriations.house.gov/sites/evo-subsites/republicans-appropriations.house.gov/files/evo-media-document/aderholt-1-manager-s-amendment.pdf" target="_blank"&gt;Manager&amp;rsquo;s Amendment&lt;/a&gt;, which includes language that would prohibit CMS from using funds to implement the Wasteful and Inappropriate Service Reduction (&lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/wiser" target="_blank"&gt;WISeR&lt;/a&gt;) Model, which applies AI to Medicare prior authorization for certain services, and would require oversight of the WISeR model&amp;rsquo;s impact on patients and providers. The Manager&amp;rsquo;s Amendment was adopted by a voice vote.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;House Appropriations Committee Releases Its FY27 Labor, Health and Human Services Appropriations Report&lt;/strong&gt;. On June 8, 2026, the House Appropriations Committee released its accompanying FY27 L-HHS &lt;a rel="noopener noreferrer" href="https://docs.house.gov/meetings/AP/AP00/20260609/119380/HMKP-119-AP00-20260609-SD003.pdf" target="_blank"&gt;report&lt;/a&gt;. Appropriations bill reports clarify funding levels, signal congressional intent and policy priorities to HHS agencies, provide oversight and accountability, and provide instructions on various reporting requirements.&lt;/p&gt;
&lt;p&gt;The report includes $45.5 million for the Office for the Advancement of Telehealth (OAT) to promote the effective use of technologies to improve access to health services for people who are isolated from health care services and to provide distance education for health professionals.&lt;/p&gt;
&lt;p&gt;The report also encourages CMS to leverage relevant feedback and consider policies in the upcoming proposed Medicare payment rules to provide targeted criteria to Medicare providers and medical technology innovators regarding the reimbursement pathway for FDA-authorized AI/machine learning (ML)-enabled medical devices, including algorithm-based health care services (ABHS) technologies.&lt;/p&gt;
&lt;p&gt;Additionally, in the report, the committee urges the withdrawal and rescinding of the &lt;a rel="noopener noreferrer" href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;amp;RIN=0945-AA00" target="_blank"&gt;Notice of Proposed Rulemaking&lt;/a&gt; at the Office of Management and Budget (OMB) titled, &amp;ldquo;[Health Insurance Portability and Accountability Act] HIPAA Privacy Rule: Changes to Support the Use of Telecommunications Relay Services and Improve Information Sharing for Uniformed Services Personnel.&amp;rdquo; The committee expresses concern that the proposal may unintentionally impact patient privacy protections in relation to entities that operate outside the scope of HIPAA.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;FDA Announces Public Meeting to Discuss Proposed Recommendations for Reauthorizing the MDUFA for Fiscal Years 2028 Through 2032&lt;/strong&gt;. The Food and Drug Administration (FDA) has &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/07/08/2026-13778/medical-device-user-fee-amendments-public-meeting-request-for-comments" target="_blank"&gt;announced &lt;/a&gt;a public meeting, &amp;ldquo;Medical Device User Fee Amendments,&amp;rdquo; scheduled for August 5, 2026. The meeting will focus on proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028-2032. Current statutory authority for MDUFA is set to expire on September 30, 2027.&lt;/p&gt;
&lt;p&gt;Of note, one of FDA&amp;rsquo;s recommendations for MDUFA VI includes strengthening digital health expertise and aligning review processes with software lifecycles through expanded technical capacity, enhanced reviewer training, and stakeholder engagement on emerging technologies.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;CMS Establishes the Office of Health Technology and Products&lt;/strong&gt;. On June 10, 2026, CMS &lt;a rel="noopener noreferrer" href="https://public-inspection.federalregister.gov/2026-11743.pdf" target="_blank"&gt;established&lt;/a&gt; the Office of Health Technology and Products (OHTP). The new office will focus on &amp;ldquo;technology modernization, digital products, and transforming of platforms and services supporting Medicare, Medicaid, the Children&amp;rsquo;s Health Insurance Program (CHIP), and other CMS-administered programs.&amp;rdquo; OHTP will lead strategy and implementation of AI across CMS&amp;rsquo; digital products and platforms, as well as advise CMS leadership on AI opportunities, risk, and governance.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;UpDoc Announces That the FDA Has Cleared the First Large Language Model-Based Software as a Medical Device&lt;/strong&gt;. On June 25, 2026, UpDoc, a clinical AI company that offers a provider-integrated agentic AI platform, &lt;a rel="noopener noreferrer" href="https://updoc.com/press" target="_blank"&gt;announced&lt;/a&gt; that it received FDA clearance for the first Software as a Medical Device (SaMD) that uses large language models. The AI agent can be integrated into a provider&amp;rsquo;s electronic health records for support across clinical workflows. UpDoc states that the agent is &amp;ldquo;designed to support doctors, not replace them.&amp;rdquo; The platform was originally tested in a &lt;a rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2812420" target="_blank"&gt;clinical trial&lt;/a&gt; at Stanford Medicine and will undergo initial deployment at Cleveland Clinic, Allegheny Health Network, and UCSF Health.&lt;/p&gt;
&lt;h3&gt;&lt;a name="FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;FDA Warning Letter Regarding Modified Patient-Monitoring Software&lt;/strong&gt;. On June 12, 2026, FDA &lt;a rel="noopener noreferrer" href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nihon-kohden-digital-health-solutions-llc-727803-06122026" target="_blank"&gt;issued&lt;/a&gt; a warning letter to Nihon Kohden Digital Health Solutions, LLC concerning the company&amp;rsquo;s Next Generation NetKonnect (NGNK) software, a 510(k)-cleared patient-monitoring device. FDA concluded that the device was adulterated and misbranded because the company made significant software and intended-use changes without submitting a new 510(k).&lt;/p&gt;
&lt;p&gt;FDA disagreed with the company&amp;rsquo;s determination that the addition of a &amp;ldquo;Silence Alarms&amp;rdquo; function would not significantly affect the device&amp;rsquo;s safety or effectiveness. The agency characterized the feature as a change to the device&amp;rsquo;s control mechanism because it alters how users control alarms and could cause alarms for life-threatening conditions to be missed, potentially resulting in serious injury or death. FDA therefore determined that the change required a new 510(k).&lt;/p&gt;
&lt;p&gt;FDA also found that the company was marketing the NGNK software as having &amp;ldquo;device-agnostic compatibility,&amp;rdquo; including the ability to receive data from devices manufactured by third parties. The cleared device, however, was limited to inputs from other Nihon Kohden devices. FDA concluded that expanding compatibility to unvalidated third-party devices constituted a major change in intended use and could create interoperability risks, including incorrect vital-sign measurements, loss of monitoring, delayed diagnosis, or misdiagnosis.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;FDA Requests Input on Certain Non-Device Software Functions and Impacts to Patient Safety&lt;/strong&gt;. On July 14, 2026, FDA &lt;a rel="noopener noreferrer" href="https://www.fda.gov/about-fda/cdrh-reports/reports-non-device-software-functions" target="_blank"&gt;announced&lt;/a&gt; that it is seeking public input to inform its forthcoming 2026 report on the risks and benefits of certain software functions that are excluded from the statutory definition of a medical device under the 21st Century Cures Act. FDA is specifically requesting information regarding patient-safety impacts and best practices for promoting safety, education, and user competency. Comments are due August 13, 2026. The request covers five categories of non-device software functions: software intended to support health care facility administration; encourage a healthy lifestyle; serve as an electronic patient record; transfer, store, convert, or display medical data; and provide certain limited clinical decision support. Although these functions generally fall outside FDA&amp;rsquo;s device regulatory authority, the agency is required to report every two years on their health-related risks and benefits and their effects on patient safety.&lt;/p&gt;
&lt;p&gt;
&lt;/p&gt;
&lt;h3&gt;&lt;a name="Provider Reimbursement"&gt;Provider Reimbursement&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;Calendar Year Physician Fee Schedule Proposed Rule.&lt;/strong&gt; On July 16, 2026, CMS &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/07/16/2026-14327/medicare-and-medicaid-programs-cy-2027-payment-policies-under-the-physician-fee-schedule-and-other" target="_blank"&gt;published&lt;/a&gt; the calendar year (CY) 2027 Medicare Physician Fee Schedule proposed rule. The proposed rule includes several notable policies concerning remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), telehealth services, and technology-enabled primary care.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Remote Monitoring&lt;/strong&gt;. In response to growing program-integrity concerns &amp;mdash; including an &lt;a rel="noopener noreferrer" href="https://oig.hhs.gov/documents/evaluation/10001/OEI-02-23-00260.pdf" target="_blank"&gt;HHS Office of Inspector General report&lt;/a&gt; identifying the need for additional oversight of RPM services &amp;mdash; CMS proposes several changes intended to strengthen billing requirements and address program-integrity concerns involving RPM and RTM services. CMS proposes to:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Require RTM services to be furnished only to established patients, consistent with the existing requirement for RPM services, reasoning that an established patient relationship allows the practitioner to confirm that remote monitoring is medically necessary and to develop a treatment plan based on a prior evaluation of the patient.&lt;/li&gt;
    &lt;li&gt;Require practitioners billing RPM or RTM services to furnish a separately reportable initiating visit in association with the onset of the remote monitoring services. The initiating visit would be required even when the patient has recently received another service from the practitioner, unless that service independently qualifies as the initiating visit.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Pay for RPM and RTM treatment-management services only when the clinical staff furnishing the services are employed by the billing practitioner&amp;rsquo;s practice. CMS expresses concern that arrangements involving third-party vendors may result in the billing practitioner exercising insufficient supervision or involvement in the patient&amp;rsquo;s care.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;CMS also proposes to revise the valuation of certain RPM and RTM services based on its understanding that remote monitoring devices may now be available at lower costs than CMS originally estimated. CMS also seeks comments on whether it should replace the existing RPM and RTM CPT code families with four bundled HCPCS G-codes.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Medicare Telehealth Services List&lt;/strong&gt;. CMS proposes to add five new HCPCS G-codes to the Medicare Telehealth Services List for CY27: (1) advance care planning furnished by clinical staff under the direction of a treating practitioner (HCPCS codes GACP1 and GACP2); (2) voluntary shared medical appointments involving groups of two to 10 patients with common medical conditions (HCPCS code GSMAS); (3) individual speech, language, voice, communication, or auditory-processing treatment furnished to pediatric patients (HCPCS code GSLPP); and (4) an add-on code for evaluation and management services involving the diagnosis and treatment of vaccine adverse effects (HCPCS code GADV1).&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Telehealth Flexibilities and Modifiers&lt;/strong&gt;. As discussed in our &lt;a href="/en/perspectives/publications/2026/02/virtual-and-digital-health-digest"&gt;February 2026 digest&lt;/a&gt;, Congress extended COVID-19-era Medicare telehealth flexibilities through December 31, 2027, as part of the Consolidated Appropriations Act (CAA), 2026. CMS proposes updates to its telehealth regulations to reflect the additional extension. As required by the CAA, 2026, CMS also proposes to establish new claims modifiers for telehealth services furnished through certain third-party virtual platforms and for telehealth services furnished incident to a physician&amp;rsquo;s or practitioner&amp;rsquo;s professional services.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Technology-Enabled Primary Care&lt;/strong&gt;. CMS seeks comments on potential changes to the valuation and payment of primary care services, including how Medicare should account for technology used in primary care. Among other issues, CMS requests feedback on whether technology should be incorporated into primary care payment through existing service-level payments, prospective payments, or other payment arrangements. CMS also seeks comments on establishing prospective primary care payments through the Medicare Shared Savings Program and potentially more broadly in Original Medicare.&lt;/p&gt;
&lt;p&gt;Comments on the proposed rule are due September 14, 2026.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;CY27 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule&lt;/strong&gt;.&amp;nbsp;On July 7, 2026, CMS &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment" target="_blank"&gt;published&lt;/a&gt; the CY27 Medicare Hospital OPPS proposed rule. As it has in the past, the agency addresses artificial intelligence-enabled clinical software in its ongoing attempts to further develop OPPS payment policy for these technologies.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Software as a Medical Service&lt;/strong&gt;. CMS proposes establishing a new payment framework for certain software-based medical technologies that use algorithms, including artificial intelligence, to perform diagnostic or other clinical functions. CMS would replace the term &amp;ldquo;Software as a Service&amp;rdquo; with &amp;ldquo;Software as a Medical Service&amp;rdquo; (SaMS) to distinguish these technologies from general cloud-based software and to recognize their role in furnishing medical services. CMS explains that existing Medicare payment methodologies may not adequately account for proprietary algorithms, licensing arrangements, and other non-material costs associated with these technologies.&lt;/p&gt;
&lt;p&gt;For CY27, CMS proposes to designate 36 HCPCS codes as SaMS services and generally assign separately payable codes to New Technology Ambulatory Payment Classifications. CMS also proposes a new OPPS status indicator, &amp;ldquo;O1,&amp;rdquo; for separately payable SaMS services. Services assigned status indicator O1 would receive a separate APC payment and would not be discounted when furnished with another procedure. CMS is seeking comment, however, on whether SaMS services should instead be subject to multiple-procedure payment reductions when more than one software-based analysis is performed during the same encounter.&lt;/p&gt;
&lt;p&gt;CMS also proposes moving certain stand-alone algorithmic analyses of laboratory data from the Clinical Laboratory Fee Schedule to the OPPS. Under the proposal, these services would be treated as &amp;ldquo;other diagnostic tests&amp;rdquo; and paid through New Technology APCs.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;The proposal represents an important step toward creating a distinct Medicare payment pathway for AI- and algorithm-based clinical services. Although CMS characterizes the framework as interim, the SaMS designation could shape future coding, payment, packaging, and program-integrity policies for digital health technologies. CMS also seeks comments on longer-term payment methodologies, including whether payment should be tied more closely to clinical outcomes and whether multiple-procedure payment reductions should apply.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Comments on the proposed rule are due August 31, 2026.&lt;/p&gt;
&lt;h2&gt;EU and UK News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://ec.europa.eu/newsroom/sante/newsletter-archives/74172" target="_blank"&gt;&lt;/a&gt;&lt;strong&gt;&lt;a href="https://www.consilium.europa.eu/en/press/press-releases/2026/06/16/council-agrees-mandate-on-measures-to-advance-biotech-innovation-in-the-eu/" target="_blank"&gt;Council of the European Union (Council) Adopts Position on the EU Biotech Act I&lt;/a&gt;&lt;/strong&gt;. The Council of the European Union has adopted its general approach on the European Commission&amp;rsquo;s proposed &lt;a rel="noopener noreferrer" href="https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf" target="_blank"&gt;Biotech Act Part I &lt;/a&gt;(For more details on the European Commission proposal, read our&lt;a href="/en/perspectives/publications/2026/01/virtual-and-digital-health-digest"&gt; January 2026 Digest&lt;/a&gt;). This general approach will serve as its negotiating mandate for trilogue discussions with the European Parliament, should they take place. Among the key amendments, the Council has clarified that, in the context of the processing of personal data, it may be considered to be carried out in the public interest where necessary to ensure patient safety, maintain high health care standards, or support cross-border analysis of transplant outcomes.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/extending-supplementary-protection-certificate-spc-could-increase-european-rd-investment-tenfold/" target="_blank"&gt;European Federation of Pharmaceutical Industries and Associations (EFPIA) Publishes Its Position on the EC-Proposed EU Biotech Act Part I&lt;/a&gt;&lt;/strong&gt;. The position welcomes key measures proposed by the EC, including a harmonized General Data Protection Regulation (EU) 2016/679 (GDPR) legal basis for clinical trial data processing, clearer and harmonized responsibilities regarding controllership of data under the GDPR, and the possibility for further use of clinical trial data for research purposes under certain conditions. At the same time, EFPIA calls for risk-based guidance from the European Medicines Agency and the European Medicines Regulatory Network on the use of AI models and systems.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://digital-strategy.ec.europa.eu/en/policies/code-practice-ai-generated-content" target="_blank"&gt;European Commission Publishes Code of Practice on Marking and Labeling AI-Generated Content&lt;/a&gt;&lt;/strong&gt;. The code is voluntary, but it sets out practical steps to help providers and deployers of generative AI systems meet the AI Act transparency obligations that will apply from August 2, 2026. The AI Act will require clear labeling, particularly for deepfakes and AI-generated or AI-manipulated text published on matters of public interest. The European Commission has also created a&lt;a rel="noopener noreferrer" href="https://digital-strategy.ec.europa.eu/en/policies/eu-icons-labelling-ai-generated-content" target="_blank"&gt; set of icons&lt;/a&gt; that deployers may use to label their AI-generated content. Providers and deployers of generative AI systems may sign up to the code using the &lt;a rel="noopener noreferrer" href="https://digital-strategy.ec.europa.eu/en/library/how-sign-code-practice-transparency-ai-generated-content" target="_blank"&gt;signatory form&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf" target="_blank"&gt;European Commission&amp;rsquo;s Medical Device Coordination Group (MDCG) Publishes Position Paper on Manufacturer Responsibility to Upload Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) Documents in EUDAMED&lt;/a&gt;&lt;/strong&gt;. The position paper clarifies the future responsibilities for uploading the SSCP and SSP to EUDAMED, the EU centralized database for medical devices and in vitro diagnostics. Under the current process, the SSCP and SSP documents are uploaded by the Notified Body when registering certificate information. The MDCG guidance &lt;a rel="noopener noreferrer" href="https://health.ec.europa.eu/system/files/2022-03/md_mdcg_2019_9_sscp_en.pdf" target="_blank"&gt;MDCG 2019-9 Rev. 1&lt;/a&gt; is being revised such that the manufacturer will have responsibility for uploading the SSCPs and SSPs in EUDAMED. It will also be the responsibility of the manufacturer to ensure the uploaded SSCP or SSP is the one validated by the Notified Body. The MDCG foresees a transition period whereby Notified Bodies will continue uploading the validated master SSCPs and SSPs until the new functionality is available in October 2026.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.medtecheurope.org/2026/06/04/medtech-europe-reaction-to-the-provisional-agreement-on-the-digital-omnibus-on-ai/" target="_blank"&gt;MedTech Europe Reaction to Provisional Agreement on the AI Digital Omnibus&lt;/a&gt;&lt;/strong&gt;. MedTech Europe has reacted to the &lt;a rel="noopener noreferrer" href="https://digital-strategy.ec.europa.eu/en/news/simpler-eu-digital-rules-and-new-digital-wallets-save-billions-businesses-and-boost-innovation" target="_blank"&gt;Digital Omnibus package&lt;/a&gt; that was presented by the European Commission in November 2025, aiming to streamline rules on AI, cybersecurity, and data. MedTech Europe advocates for a sectoral approach for medical devices to avoid overlapping obligations. However, the provisional agreement does not include a sectoral approach for medical technologies, which remain subject to parallel requirements under both the AI Act and the Medical Devices Regulation 2017/745 (MDR)/In Vitro Diagnostic Regulation 2017/746 (IVDR). Some of MedTech Europe&amp;rsquo;s other recommendations have been implemented, such as the postponement of the application of AI Act requirements for high-risk AI systems embedded in products, including medical technologies, from August 2026 to August 2028.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://digital-strategy.ec.europa.eu/en/news/ai-act-enforcement-gets-independent-expert-support" target="_blank"&gt;European Commission Appoints a Scientific Panel and an Advisory Forum to Support AI Act Enforcement&lt;/a&gt;&lt;/strong&gt;. The two bodies will advise the European Commission&amp;rsquo;s AI Office and national competent authorities on the implementation and enforcement of the AI Act. The Scientific Panel, comprising 60 independent experts, will provide advice on matters relating to, among others, general-purpose AI models and systems, systemic risks, model classification, evaluation methodologies, and cross-border market surveillance. The Advisory Forum, comprising representatives from academia, civil society, and industry, including small and medium-sized enterprises and startups, will provide advice on matters relating to, among others, standardization, AI literacy, and AI Act implementation.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/mhra-launches-ai-sandbox-to-accelerate-medicines-development-and-improve-safety" target="_blank"&gt;UK MHRA Launches AI Sandboxes to Accelerate Medicines Development&lt;/a&gt;&lt;/strong&gt;. The MHRA has launched an initiative to test how AI can accelerate medicines development and improve safety. The program will allow innovators to test AI tools that have the potential to predict how medicines behave in the body, including how they are absorbed, processed, and whether they may cause harm. The MHRA intends to use this work to understand how reliable these AI tools are and whether they can be used to support decisions about the safety of new medicines. Up to five AI-driven approaches will be tested in the first phase. The MHRA will begin working with industry and academic partners over the coming months to shape how the sandbox operates. In addition, the MHRA is &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/pioneering-ai-health-innovations-regulatory-sandbox-launched?utm_medium=email&amp;amp;utm_campaign=govuk-notifications-topic&amp;amp;utm_source=b9e0372b-8566-449d-bd97-de5f34b7323a&amp;amp;utm_content=immediately" target="_blank"&gt;launching&lt;/a&gt; a similar sandbox focused on London for up to 10 AI manufacturers, and will invite expressions of interest from AI medical device manufacturers in July 2026.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://assets.publishing.service.gov.uk/media/6a676af523e57bd0a0ea6852/AI_Airlock_Phase_2_Programme_Report_v2.pdf" target="_blank"&gt;UK MHRA Publishes Report on AI Airlock Sandbox Phase 2&lt;/a&gt;&lt;/strong&gt;. The MHRA has published its report of Phase 2 of the AI Airlock regulatory sandbox, alongside &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/publications/ai-airlock-simulation-workshops" target="_blank"&gt;three simulation workshop summary reports&lt;/a&gt;. The program ran from April 2025 to March 2026 and worked with seven AI technologies across a range of clinical applications, including AI-powered clinical note-taking, advanced cancer diagnostics, rare eye disease detection, and obesity management systems. In a &lt;a rel="noopener noreferrer" href="https://medregs.blog.gov.uk/2026/06/09/advancing-ai-regulation-in-healthcare-insights-from-ai-airlock-phase-2/" target="_blank"&gt;MedRegs blog post&lt;/a&gt;, the MHRA notes that pre-market evidence needs to be designed with deployment conditions in mind, and post-market monitoring is critical for these technologies. The MHRA also states that clinical relevance should underpin performance metrics, as a consistent finding across candidate cases was that statistical significance did not always equate to clinical importance. The insights from the AI Airlock pilot phase were reported in the &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2025/12/virtual-and-digital-health-digest-november-2025/" target="_blank"&gt;November 2025 Digest&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/publications/national-commission-into-the-regulation-of-ai-in-healthcare-research-engagement-and-call-for-evidence-findings" target="_blank"&gt;UK MHRA Publishes Findings on National Commission&amp;rsquo;s Research Into the Use of AI in Healthcare&lt;/a&gt;&lt;/strong&gt;. The MHRA has published two reports summarizing the findings from the research and engagement activities of the National Commission into the Regulation of AI in Healthcare, as well as the outcome of the associated Call for Evidence (which we initially reported on in the &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/01/virtual-and-digital-health-digest-december-2025/" target="_blank"&gt;December 2025 Digest&lt;/a&gt;). In a &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/mhra-landmark-report-reveals-public-views-on-ai-in-healthcare#full-publication-update-history" target="_blank"&gt;press release&lt;/a&gt;, the MHRA says the overarching view from the engagement is a recognition of the potential benefits of AI in healthcare, provided that rules appropriately set standards for safety and efficacy. The MHRA also says there is a broad consensus that existing regulatory approaches need to be adapted to meet the rapid pace of change and development of AI technology. These reports will inform the AI commission&amp;rsquo;s recommendations, which are due to be published later this year to assist the MHRA in shaping rules that protect patients and support innovation.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://mhrainspectorate.blog.gov.uk/2026/06/29/use-of-ai-for-gxp-inspection-responses-setting-standards-without-stifling-innovation/" target="_blank"&gt;UK MHRA Publishes Blog Post on Use of AI in GxP Inspection Responses&lt;/a&gt;&lt;/strong&gt;. The MHRA has published a blog post on its position on the use of AI in submissions made to its compliance teams following GxP inspections. The post acknowledges that AI tools can support better regulatory outcomes and improve patient safety, but the agency has encountered responses containing references to MHRA guidance that does not exist, citations of inappropriate regulatory frameworks, and responses to serious deficiencies that appear designed to mislead rather than address underlying problems. The MHRA sets out several clarifications, stressing that all submissions must be accurate and supported by evidence. It also offers organizations the opportunity to voluntarily disclose AI use in responses to compliance teams, to help the MHRA understand how the sector is evolving. The MHRA says inspectors will consider this disclosure positively when assessing organizational compliance.&lt;/p&gt;
&lt;p&gt;
&lt;/p&gt;
&lt;h3&gt;&lt;a name="Pricing and Reimbursement Updates"&gt;Pricing and Reimbursement Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/publications/value-based-procurement-for-medical-technology/value-based-procurement-national-standard-guidance-for-medical-technology" target="_blank"&gt;UK Government Publishes Guidance for NHS Buyers Assessing Medical Technology&lt;/a&gt;&lt;/strong&gt;. The UK government has published guidance for National Health Service (NHS) buyers on &amp;ldquo;value based procurement&amp;rdquo; when buying medical technology. The guidance provides a standard set of questions and scoring criteria to help assess the wider value of the technology, not just its purchase price. These other value criteria include benefits for productivity and efficiency in hospitals, patient experience and outcomes, staff experience and safety, the environment, and supply chain resilience. The guidance is intended for use at the quality assessment stage of the procurement process.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.edpb.europa.eu/system/files/2026-04/edpb_guidelines_202601_scientificresearch_en.pdf" target="_blank"&gt;&lt;/a&gt;&lt;strong&gt;&lt;a href="https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2026/05/ico-response-to-government-on-safe-ai-powered-innovation/" target="_blank"&gt;UK ICO Sets Out AI Workplan Priorities in Response to Government Request&lt;/a&gt;&lt;/strong&gt;. On May 29, 2026, the ICO published its response to a joint request from the Technology and Business Secretaries to set out a plan for enabling safe AI-powered innovation. The response builds on the ICO&amp;rsquo;s June 2025 AI and biometrics strategy and confirms that its 2026/2027 workplan will focus on: developing an AI and automated decision-making (ADM) statutory code of practice (informed by the ADM consultation which closed on May 29, 2026, with final guidance due Summer 2026); publishing dedicated guidance on agentic AI; and supporting consumers navigating an increasingly personalized AI landscape. This is relevant to life sciences companies deploying AI-enabled tools in clinical, diagnostic, or patient-facing contexts, an area the ICO has previously flagged as a priority.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2026/06/setting-out-our-expectations-for-the-smart-device-industry/" target="_blank"&gt;UK ICO Publishes Final Guidance on Consumer IoT Products and Services&lt;/a&gt;&lt;/strong&gt;. On June 11, 2026, the ICO published its finalized guidance on consumer Internet of Things (IoT) products and services, following a 12-week consultation held last year. The guidance covers smart speakers, connected televisions, fitness trackers, wearables, smart doorbells, and other consumer connected devices, and applies to manufacturers, app developers, operating system providers, and cloud providers in the IoT supply chain (it does not cover smart meters, connected/autonomous vehicles, or enterprise/industrial IoT). It sets out expectations that privacy be built in by default, that consent be specific and as easy to withdraw as to give, and that most IoT processing will require a Data Protection Impact Assessment, with an even higher bar where children are likely users. This is relevant for life sciences companies developing consumer-facing wearables or health-monitoring devices that sit outside the medical device regulatory perimeter. The ICO has confirmed it is now turning its attention to connected televisions.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{B9E5A254-8874-42F5-8D7F-51E6352ADE14}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-advises-panama-on-two-financings-totaling-2-9-billion</link><title>Arnold &amp; Porter Advises Panama on Two Financings Totaling €2.9 Billion</title><description>Arnold &amp;amp; Porter recently advised the Republic of Panama on two separate sovereign financing transactions totaling &amp;euro;2.9 billion, one with Banco Santander and the other with Merrill Lynch International, a Bank of America affiliate.</description><pubDate>Wed, 29 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised the Republic of Panama on two separate sovereign financing transactions totaling &amp;euro;2.9 billion, one with Banco Santander and the other with Merrill Lynch International, a Bank of America affiliate.&lt;/p&gt;
&lt;p&gt;In the first transaction, Santander provided a &amp;euro;1.2 billion loan bearing interest at a fixed rate of 4.83%. The proceeds were used to refinance debt scheduled to mature in 2027. In the second transaction, Merrill Lynch provided a &amp;euro;1.7 billion loan bearing interest at a fixed rate of 4.67%. That financing comprised &amp;euro;1.2 billion used to refinance additional debt scheduled to mature in 2027 and &amp;euro;500 million of new financing.&lt;/p&gt;
&lt;p&gt;Together, the two transactions allowed Panama to address &amp;euro;2.4 billion of its 2027 maturities in advance, extend the relevant debt maturities to 2031, and secure fixed-rate financing at rates below the Government&amp;rsquo;s estimated cost of a comparable market issuance.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by partners Whitney Debevoise and Gregory Harrington, and included counsel Arturo Caraballo and senior associate Mateo Morris. Tax advice was provided by partner David Sausen and associate Lauren Olaya.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C1340167-F4A1-464C-BF1D-9022A0BBF008}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/jami-vibbert-discusses-the-evolving-privacy-and-ai-landscape-in-law360</link><title>Jami Vibbert Discusses the Evolving Privacy and AI Landscape in Law360</title><description>Jami Vibbert, chair of Arnold &amp;amp; Porter&amp;rsquo;s Privacy, Cybersecurity &amp;amp; Data Strategy practice, was quoted in two recent &lt;em&gt;Law360 &lt;/em&gt;articles examining the rapidly evolving privacy, artificial intelligence, and data governance landscape.</description><pubDate>Wed, 29 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Jami Vibbert, chair of Arnold &amp;amp; Porter's Privacy, Cybersecurity &amp;amp; Data Strategy practice, was quoted in two recent&lt;em&gt; Law360 &lt;/em&gt;articles examining the rapidly evolving privacy, artificial intelligence, and data governance landscape.&lt;/p&gt;
&lt;p&gt;In the article "Top Privacy and AI Developments of 2026: Midyear Report," Jami observed that "there is a new law that is impacting clients in this space almost every day," explaining that organizations are increasingly seeking guidance on navigating overlapping privacy and AI obligations. Rather than focusing on compliance with a single statute, she noted that clients are now asking, "Here's where we're moving with respect to technology and data, and how do we comply with all the different laws that may impact us?"&lt;/p&gt;
&lt;p&gt;In a follow-up article, "Data Privacy &amp;amp; AI Issues To Watch For the Rest of 2026," Jami discussed the U.S. Supreme Court's pending review of the federal Video Privacy Protection Act, noting that the Court's decision could significantly shape future privacy litigation. She explained that the ruling could not only curb future VPPA claims but also help limit broader online tracking lawsuits if the Court indicates that "these older laws are not the right fit for addressing online tracking technology."&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2494535/top-privacy-and-ai-developments-of-2026-midyear-report"&gt;Read "Top Privacy and AI Developments of 2026: Midyear Report"&lt;/a&gt;&amp;nbsp;(subscription required).&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2505045/data-privacy-ai-issues-to-watch-for-the-rest-of-2026"&gt;Read "Data Privacy &amp;amp; AI Issues To Watch For the Rest of 2026"&lt;/a&gt;&amp;nbsp;(subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{960E9127-230C-462C-8787-6315C08426DC}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-advises-honduras-in-815-7m-notes-offering</link><title>Arnold &amp; Porter Advises Honduras in $815.7M Notes Offering</title><description>Arnold &amp;amp; Porter recently advised the Republic of Honduras in connection with its offering of US$815.7 million of 6.400% Notes due 2036.</description><pubDate>Wed, 29 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised the Republic of Honduras in connection with its offering of US$815.7 million of 6.400% Notes due 2036. &lt;/p&gt;
&lt;p&gt;In connection with the offering, Honduras previously announced a cash tender offer to repurchase outstanding 6.250% sovereign bonds maturing in 2027.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by counsel Arturo Caraballo and senior associate Valentina Garzon. Partner Whitney Debevoise also advised on the matter.*&lt;/p&gt;
&lt;p&gt;&lt;em&gt;*Mateus Maia de Souza, a visiting attorney from Brazil, assisted the team with aspects of the deal. Mr. Maia is admitted to practice law only in Brazil and is not engaged in the practice of law in any U.S. jurisdiction.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{FCA32E82-721C-4D60-93A4-4751B033E0F3}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/sec-proposes-to-authorize-electronic-delivery-of-documents</link><a10:author><a10:name>Sara Adler</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/adler-sara</a10:uri><a10:email>sara.adler@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Joel I. Greenberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/greenberg-joel-i</a10:uri><a10:email>joel.greenberg@arnoldporter.com</a10:email></a10:author><title>SEC Proposes to Authorize Electronic Delivery of Documents Required by the Federal Securities Laws and Regulations</title><description>On July 16, 2026, the Securities and Exchange Commission (SEC) proposed Regulation E-Delivery, a new framework that would allow firms to satisfy many federal securities law delivery requirements through electronic delivery by default, without first obtaining recipients' affirmative consent, provided certain notice, opt-out, and security requirements are met. The proposal would modernize and largely replace the SEC's longstanding electronic delivery guidance while introducing standardized requirements for electronic communications, including safeguards for personal financial information, procedures for failed deliveries, and transition rules for existing paper recipients. It would also amend or rescind several existing rules governing investment company shareholder reports, proxy materials, and tender offer communications, reflecting the SEC's broader effort to align securities regulation with current technology and investor communication preferences.</description><pubDate>Wed, 29 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;On July 16, 2026, the SEC &lt;a rel="noopener noreferrer" href="https://www.sec.gov/files/rules/proposed/2026/33-11430.pdf" target="_blank"&gt;proposed&lt;/a&gt; Regulation E-Delivery (Reg E-Delivery), which if adopted would: (i) establish conditions under which the delivery requirements of the Federal securities laws could be satisfied by delivering information electronically (e-delivery) without the need to first obtain recipients&amp;rsquo; affirmative consent; (ii) rescind the rule providing alternative means for registered investment companies to satisfy shareholder report transmission requirements; and (iii) amend rules addressing the dissemination of proxy and tender offer materials to facilitate consistency with the proposed new e-delivery framework. The proposal reflects the SEC&amp;rsquo;s decades-long experience with the use of electronic media to provide investors with information, significant advances in electronic communication technologies, as well as studies on investor/stakeholder preferences.&lt;/p&gt;
&lt;h2&gt;Scope of Reg E-Delivery&lt;/h2&gt;
&lt;p&gt;The proposal addresses e-delivery to &amp;ldquo;covered recipients&amp;rdquo; of &amp;ldquo;covered information&amp;rdquo; by &amp;ldquo;covered entities.&amp;rdquo; A &amp;ldquo;covered recipient&amp;rdquo; would be any current or prospective customer, client, investor, security holder, counterparty, or similar recipient of information (other than the SEC, any other Federal or state regulator, or any self-regulatory organization (SRO)). &amp;ldquo;Covered information&amp;rdquo; would be any information required to be delivered to a covered recipient under the Federal securities laws, other than: (i) information required to be delivered under Regulation Crowdfunding, Exchange Act Rule 15c2-11 (which prohibits brokers from publication or submission for publication of quotations unless specified information is available), and Exchange Act Rule 15Fi-2(c) (acknowledgment and verification of security-based swap transactions), as each of the foregoing reflects a tailored e-delivery framework; (ii) information required to be filed with the SEC or otherwise made available generally to the public but not delivered to particular recipients, and (iii) disclosures made pursuant to any applicable state laws or the rules of SROs, including FINRA and the Municipal Securities Rulemaking Board.[[N:As a non-exhaustive list, covered information would include: fund prospectuses, fund annual and semi-annual shareholder reports, notices under Investment Company Act Rule 19a-1, issuer prospectuses, issuer annual reports to security holders, proxy statements and information statements, tender offer statements and solicitation/recommendation statements, offering circulars, bondholders&amp;rsquo; lists and reports to security holders, trade confirmations, disclosures pursuant to Form CRS, Reg S-AM disclosures, Form ADV Part 2 Brochures, marketing and testimonial disclosures, agency cross transaction disclosures, and custody rule account statement notices.]] &amp;ldquo;Covered entities&amp;rdquo; would be any person that has an obligation to deliver covered information to a covered recipient under the Federal securities laws.[[N:This would include persons registered under the Exchange Act, the Investment Advisers Act, and the Investment Company Act, persons with a class of securities registered under the Exchange Act, persons conducting securities offerings registered or exempt from the registration requirements under the Securities Act, persons subject to the requirements of the Trust Indenture Act, as well as bidders for third-party tender offers and dissidents in contested proxy solicitations. However, persons that have delivery obligations to covered recipients pursuant only to the rules of SROs are not included within the scope of Reg E-Delivery.]] Reg E-Delivery would permit (but not require) covered entities to use e-delivery as the default method of delivery for covered information.&lt;/p&gt;
&lt;h2&gt;General Requirements&lt;/h2&gt;
&lt;p&gt;A covered entity would be able to rely on the proposed rule to use e-delivery to satisfy its delivery obligations for covered information (regardless of whether it elects to use e-delivery as a default or continues to require affirmative consent to e-delivery) if: (i) the covered recipient has provided an electronic address to receive covered information (or in the case of electronic addresses that are mobile applications, accepts to use);[[N:An electronic address is an identifier used to communicate with a covered recipient electronically, including: an email address; a mobile phone number; or any other means of electronic communication capable of receiving electronic delivery pursuant to an electronic delivery method that the rule sets forth and alerting a covered recipient that covered information is available. A covered recipient that provides an email address to a covered entity in the process of onboarding with that entity would be deemed to have &amp;ldquo;provided&amp;rdquo; that email address &amp;ldquo;to receive covered information.&amp;rdquo; Similarly, by using a mobile application or an online account to access covered information, a covered recipient has &amp;ldquo;accepted to use&amp;rdquo; that mobile application or online account.]] (ii) the covered entity has provided a prominent disclosure to the covered recipient that it will send covered information to the electronic address provided; and (iii) the covered recipient has not opted out of e-delivery. Covered entities may limit their use of e-delivery to certain covered information and/or to certain covered recipients (such as institutional investors). Although a covered entity may use a method of e-delivery that differs from those contemplated in Reg E-Delivery, so long as that method provides assurance of delivery comparable to paper delivery, use of the methods provided would assure that applicable delivery requirements under Federal Securities laws will have been satisfied.&lt;/p&gt;
&lt;p&gt;The proposal includes two methods of e-delivery: (i) direct delivery, and (ii) a statement of availability. A covered entity could electronically deliver covered information directly to a covered recipient&amp;rsquo;s electronic address (e.g., attached to or included in the body of an email) only if it does not include personal financial information (PFI). Electronic delivery of covered information that includes PFI would require delivery to the covered recipient&amp;rsquo;s electronic address of a statement of availability (which must not contain PFI, and must specify a website or mobile application where a covered recipient would be able to access the covered information that requires the use of a process reasonably designed to safeguard the PFI, such as passwords, two-factor authentication, biometrics, or cryptography). A covered entity also would be permitted to use this e-delivery method for covered information that does not include PFI. The statement of availability must include a prominent statement identifying the covered entity and the type of covered information that is available, a brief description of the covered information, whether the covered information may require action by the covered recipient within a fixed time frame to exercise certain rights, and whether the covered information is delivered by a person delivering on behalf of the covered entity. A message directly delivering covered information must include substantially the same information regarding the nature of the information being delivered. The website address relied upon for compliance with Reg E-Delivery may not be the SEC&amp;rsquo;s website address.&lt;/p&gt;
&lt;p&gt;Regardless of the e-delivery method, the delivery of covered information would need to include a prominent statement explaining the process to (without charge): (i) obtain a paper version of the covered information upon request;[[N:Such request must be made during the period the covered entity is required to retain the covered information under the Federal securities laws (or during the preceding two years if there is no such requirement).]] (ii) opt out of e-delivery at any time with respect to all or a subset of covered information; and (iii) update one&amp;rsquo;s electronic address. This statement must also direct a covered recipient to a website through which one can make these requests and updates. A covered entity that intends to e-deliver covered information by default would need to provide a clear and conspicuous disclosure to the covered recipient that describes the types of covered information that will be delivered electronically. If applicable, this disclosure must state whether a covered recipient&amp;rsquo;s request for paper or to opt out of e-delivery could result in restrictions on or termination of the covered recipient&amp;rsquo;s relationship with the covered entity. For the covered recipients that do not intend to pursue the default e-delivery model, the disclosure must inform them that they must affirmatively elect to receive covered information electronically if they so choose. Covered information must be delivered no later than the date by which it is required to be delivered under the Federal securities laws.&lt;/p&gt;
&lt;p&gt;The proposed rule would require covered entities to adopt written policies and procedures reasonably designed to identify and remediate failed e-delivery, including detecting an invalid or inoperable electronic address, and obtaining a new electronic address or delivering the covered information in paper format until the covered recipient provides a new electronic address.&lt;/p&gt;
&lt;h2&gt;Transition Process&lt;/h2&gt;
&lt;p&gt;A covered entity that wishes to transition current covered recipients receiving paper (for whom the covered entity has an electronic address) to default e-delivery would generally be required to provide a paper initial notice containing prescribed disclosures (including opt-out procedures) at least 180 days before the transition to default e-delivery, and a paper follow-up notice 30 days before the transition. However, a covered entity may begin using e-delivery at any time after the covered recipient updates or confirms an electronic address in response to the initial or follow-up notice. This transition requirement does not apply to covered recipients who already receive e-delivery for all covered information, or covered entities that do not wish to transition to default e-delivery for existing covered recipients.&lt;/p&gt;
&lt;h2&gt;E-Sign Act&lt;/h2&gt;
&lt;p&gt;To the extent that any covered information delivered under proposed Reg E-Delivery otherwise would have been subject to the consumer consent requirements of the Electronic Signatures in Global and National Commerce Act, Public Law 106-229 (114 Stat. 464) (2000) (the &amp;ldquo;E-SIGN Act&amp;rdquo;), such covered information would be exempt from such requirements.&lt;/p&gt;
&lt;h2&gt;Current E-Delivery Guidance&lt;/h2&gt;
&lt;p&gt;If the proposed rule is adopted, it would be the primary rule addressing e-delivery. Therefore, if adopted, Reg E-Delivery would supersede the SEC&amp;rsquo;s 1995 and 1996 Guidance in their entirety (with certain principles reaffirmed in any release adopting Reg E-Delivery), with the majority of its 2000 Guidance retained, with only certain sections and examples superseded by Reg E-Delivery.[[N:Use of Electronic Media for Delivery Purposes, Investment Company Act Release No. 21399 (Oct. 6, 1995) &amp;#91;60 FR 53458 (Oct. 13, 1995)&amp;#93; (&lt;a rel="noopener noreferrer" href="https://www.sec.gov/files/rules/interp/33-7233.txt" target="_blank"&gt;1995 Guidance&lt;/a&gt;); Use of Electronic Media by Broker-Dealers, Transfer Agents, and Investment Advisers for Delivery of Information, Investment Company Act Release No. 21945 (May 9, 1996) &amp;#91;61 FR 24644 (May 15, 1996)&amp;#93; (&lt;a rel="noopener noreferrer" href="https://www.sec.gov/files/rules/interp/33-7288.txt" target="_blank"&gt;1996 Guidance&lt;/a&gt;); Use of Electronic Media, Investment Company Act Release No. 24426 (Apr. 28, 2000) &amp;#91;65 FR 25843 (May 4, 2000)&amp;#93; (&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/2000/04/use-electronic-media" target="_blank"&gt;2000 Guidance&lt;/a&gt;).]]&lt;/p&gt;
&lt;h2&gt;Amendments to Current Rules&lt;/h2&gt;
&lt;p&gt;The proposal would rescind Rule 30e-3 under the Investment Company Act, which generally permits certain investment companies to satisfy shareholder report delivery requirements by making those reports available online and then providing a notice of that availability through a paper notice, such as a postcard, rather than directly mailing the report (or emailing an electronic version of the report or a link to the report) to shareholders.&lt;/p&gt;
&lt;p&gt;With respect to proxy materials, Reg E-Delivery would generally supersede the &amp;ldquo;notice and access&amp;rdquo; model currently provided by Exchange Act Rule 14a-16, by removing the ability to send a &amp;ldquo;Notice of Internet Availability&amp;rdquo; in paper (such that delivering a full set of proxy materials in paper would be the only alternative to direct e-delivery or e-delivery of a statement of availability). As shareholders would be able to access proxy materials more efficiently with direct e-delivery or e-delivery of a statement of availability of proxy materials, the related deadline in the current rule to send a notice 40 days in advance of the meeting date would no longer be necessary; regardless of the e-delivery method used, proxy materials would be required to be delivered no later than the date on which they are required to be delivered under the Federal securities laws. Accordingly, the deadline for delivering proxy materials for a routine annual meeting, whether delivered electronically or in paper, would generally be established by applicable state law. Proposed amended Rule 14a-16 would also remove the business combination exclusion, and update the means of conducting broker searches. In addition, the amended rule would remove certain content and other requirements deemed no longer necessary, but retain certain requirements specific to proxy materials, including the required legend, control/identification numbers, and deadlines for paper copy requests. Issuers would still be required to provide shareholders with a means to execute a proxy as of the time a statement of availability is first sent to shareholders.&lt;/p&gt;
&lt;p&gt;With respect to tender offers, the proposal would amend Exchange Act Rule 14d-5 to clarify that electronic delivery of tender offer materials is an acceptable method of dissemination and to further facilitate electronic delivery of tender offer materials.&lt;/p&gt;
&lt;p&gt;While the proposed rules are designed to allow shareholders to receive proxy materials and tender offer materials in the format they prefer, the proposed rules would not prevent an issuer or third party from supplementing the electronic delivery of proxy materials or tender offer materials with delivery of those materials in paper format.&lt;/p&gt;
&lt;h2&gt;Compliance Period&lt;/h2&gt;
&lt;p&gt;Under the proposal, there would be a two-year interim period before rescinding the SEC&amp;rsquo;s 1995 and 1996 Guidance. After the publication of Reg E-Delivery, but before the effective date of such rescission, a covered entity could rely either on such guidance or on Reg E-Delivery when using e-delivery to satisfy delivery requirements under the Federal securities laws.&lt;/p&gt;
&lt;p&gt;Comments are due within 60 days after publication in the Federal Register.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C2E6BEED-424B-4CAE-962A-2D140C8C1905}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/07/how-the-us-government-is-buying-now-opportunities-and-key-considerations-for-technology-companies</link><a10:author><a10:name>Sonia Tabriz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabriz-sonia</a10:uri><a10:email>sonia.tabriz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Thomas A. Pettit</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pettit-thomas</a10:uri><a10:email>thomas.pettit@arnoldporter.com</a10:email></a10:author><title>How the U.S. Government is Buying Now: Opportunities and Key Considerations for Technology Companies</title><description>This has been a dynamic time for companies that contract with the U.S. Government, or may be considering it.</description><pubDate>Tue, 28 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This has been a dynamic time for companies that contract with the U.S. Government, or may be considering it.&lt;/p&gt;
&lt;p&gt;Since President Trump took office, the administration has issued a series of executive orders and other directives calling for major changes in the way the U.S. Government purchases goods and services, with a focus on streamlining buying to enhance agility, effectiveness, and efficiency.  While these measures apply broadly, the administration has made clear that the U.S. Government seeks to entice &amp;ldquo;new entrants&amp;rdquo; into the federal marketplace&amp;mdash;such as through deregulation as well as prioritizing commercial and nontraditional contracting.  For new entrants and longstanding contractors alike, these changes are challenging to navigate, but may present new opportunities.&lt;/p&gt;
&lt;p&gt;During our program, we will walk through recent developments, this administration&amp;rsquo;s procurement priorities, and how to consider various risk areas when assessing opportunities to contract with the U.S. Government.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A537769F-E58E-498C-8023-4DC99FE09535}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/lisa-re-talks-hhs-fraud-enforcement-with-report-on-medicare-compliance</link><title>Lisa Re Talks HHS Fraud Enforcement with Report on Medicare Compliance</title><description>Lisa Re, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Assistant Inspector General for Legal Affairs at the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), was quoted in the &lt;em&gt;Report on Medicare Compliance&lt;/em&gt; article, &amp;ldquo;Exclusions May Climb as HHS Expands Authority to CMS; HHS Pauses $1B in Medicaid Payments,&amp;rdquo; discussing several HHS announcements at its press conference on July 21, 2026.</description><pubDate>Tue, 28 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Lisa Re, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Assistant Inspector General for Legal Affairs at the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), was quoted in the &lt;em&gt;Report on Medicare Compliance&lt;/em&gt; article, &amp;ldquo;Exclusions May Climb as HHS Expands Authority to CMS; HHS Pauses $1B in Medicaid Payments,&amp;rdquo; discussing several HHS announcements at its press conference on July 21, 2026.&lt;/p&gt;
&lt;p&gt;Regarding the department&amp;rsquo;s decision to pause more than $1 billion in federal Medicaid payments to California and Minnesota, Lisa emphasized the significance of the move. &lt;/p&gt;
&lt;p&gt;&amp;ldquo;This should get everyone&amp;rsquo;s attention,&amp;rdquo; she said. &amp;ldquo;It seems they are using every tool at their disposal to make the point they demand proper payments.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;She also highlighted HHS-OIG&amp;rsquo;s announcement that it is reviewing the performance of all state Medicaid Fraud Control Units (MFCUs), emphasizing that providers submitting Medicaid claims should use this as an opportunity to conduct their own risk assessments.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;Enforcement in Medicaid is a top priority for this administration,&amp;rdquo; Lisa said. &amp;ldquo;This is the time to invest in internal auditing.&amp;rdquo;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;a href="https://assets.hcca-info.org/Portals/0/PDFs/Publications/report-on-medicare-compliance-v35n27%20%5b07-27-2026%5d.pdf?utm_medium=email&amp;amp;_hsenc=p2ANqtz-_AhawGgTY6CLBNo1zmHFLyjP-KYK1TwYrtxgWa05rrWTFnhoW5HNGs6fKvlolnShv5RqEa2B4btAS9BHexAVyRY3m_qzfA2rqKezoU3Ihqg2mDc2Y&amp;amp;_hsmi=430307723&amp;amp;utm_content=430307723&amp;amp;utm_source=hs_email"&gt;Read the full article.&lt;/a&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{02B4A845-634F-46A1-9FEF-3F90F830BB1C}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/stacey-halliday-and-jennifer-kwapisz-discuss-oregon-epr-trial-with-packaging-dive</link><title>Stacey Halliday and Jennifer Kwapisz Discuss Oregon EPR Trial with Packaging Dive</title><description>Arnold &amp;amp; Porter Environmental partner Stacey Halliday and Product Liability Litigation partner Jennifer Kwapisz were quoted in the recent&lt;em&gt; Packaging Dive&lt;/em&gt; article, &amp;ldquo;Oregon EPR trial: What to watch next,&amp;rdquo; discussing&lt;em&gt; National Association of Wholesaler-Distributors v. Feldon&lt;/em&gt;, the first extended producer responsibility lawsuit to go to trial.</description><pubDate>Tue, 28 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Environmental partner Stacey Halliday and Product Liability Litigation partner Jennifer Kwapisz were quoted in the recent &lt;em&gt;Packaging Dive&lt;/em&gt; article, &amp;ldquo;Oregon EPR trial: What to watch next,&amp;rdquo; discussing&lt;em&gt; National Association of Wholesaler-Distributors v. Feldon&lt;/em&gt;, the first extended producer responsibility lawsuit to go to trial. &lt;/p&gt;
&lt;p&gt;Jennifer emphasized that the upcoming post-trial briefing will be particularly useful in expanding on the parties&amp;rsquo; legal arguments.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;Very often, courts, when they do draft their opinions, will pay very close attention to that post-trial briefing and to the authorities that are cited in there,&amp;rdquo; she said. &amp;ldquo;The post-trial briefing is where we&amp;rsquo;ll see the most comprehensive set of arguments and evidence laid out.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Stacey noted that the outcome of the trial also has implications for producers&amp;rsquo; compliance programs, as it remains unclear exactly how the joint enforcement by the Oregon Department of Environmental Quality (DEQ) and Circular Action Alliance Oregon (CAA) may unfold.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&amp;ldquo;My interest is in watching to what extent there will be more transparency around the enforcement process from CAA and DEQ to delineate those separate roles, particularly given the increased scrutiny of their oversight of the EPR program during litigation,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.packagingdive.com/news/oregon-extended-producer-responsibility-trial-next-steps/825749/?utm_source=Sailthru&amp;amp;utm_medium=email&amp;amp;utm_campaign=Issue:%202026-07-21%20Packaging%20Dive%20%5Bissue:87229%5D&amp;amp;utm_term=Packaging%20Dive"&gt;Read the full article.&lt;/a&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{4A9AE970-6DFD-47D1-9E7C-E8FA2D4BE50D}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-grows-international-trade-commission-litigation-practice-with-partner-brian-hill</link><title>Arnold &amp; Porter Grows International Trade Commission Litigation Practice with Partner Brian Hill</title><description>&lt;strong&gt;WASHINGTON, D.C., July 27, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Brian Hill has joined the Intellectual Property practice as a partner, focused on U.S. International Trade Commission (ITC) matters. Brian will reside in the firm&amp;rsquo;s Washington, D.C. office.</description><pubDate>Mon, 27 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;WASHINGTON, D.C., July 27, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Brian Hill has joined the Intellectual Property practice as a partner, focused on U.S. International Trade Commission (ITC) matters. Brian will reside in the firm&amp;rsquo;s Washington, D.C. office.&lt;/p&gt;
&lt;p&gt;Evan Rothstein, co-chair of the firm&amp;rsquo;s Intellectual Property practice group, said: &amp;ldquo;Brian is an established authority and thought leader in the specialized area of ITC matters. He regularly leads complex investigations for brand name clients on both sides of the aisle. As patent litigation increasingly includes attendant Section 337 investigations at the ITC, Brian&amp;rsquo;s arrival will enhance the group&amp;rsquo;s capabilities to provide full-service IP advice and counsel, especially in our robust ITC practice in Washington, D.C.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;Brian is an intellectual property litigator with an emphasis on cross-border technology and life sciences disputes. He devotes a significant portion of his practice to unfair import investigations before the ITC, drawing on extensive experience spanning dozens of Section 337 matters. In addition to patent and trademark cases, his ITC experience includes trade secret theft, unfair competition under the Lanham Act, and antitrust allegations. In life sciences, Brian has had success using Section 337 to address counterfeit medical devices entering the U.S. supply chain as well as falsely advertised and mislabeled pharmaceuticals. Earlier in his career, Brian worked at the ITC and at the U.S. Patent and Trademark Office.&lt;/p&gt;
&lt;p&gt;In joining the firm, Brian said: &amp;ldquo;Arnold &amp;amp; Porter has key strengths in IP litigation and representing clients before federal agencies, which matters enormously at the ITC, where the two are inseparable. I look forward to working with new colleagues to continue growing the firm&amp;rsquo;s ITC strength, particularly in the technology and life sciences industries.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Before joining Arnold &amp;amp; Porter, Brian was a partner at another Am Law 100 firm. Brian earned his J.D. from the University of Maryland School of Law, &lt;em&gt;cum laude&lt;/em&gt;, his M.A. from Columbia University, and his B.S. from the University of Delaware.&lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E0C1079F-53A7-4308-ABCD-70DF2E51F23B}</guid><link>https://www.biosliceblog.com/2026/07/the-eu-packaging-and-packaging-waste-regulation-why-life-sciences-companies-should-act-now/</link><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tom Fox</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fox-tom</a10:uri><a10:email>Tom.Fox@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Camille Vermosen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vermosen-camille</a10:uri><a10:email>camille.vermosen@arnoldporter.com</a10:email></a10:author><title>The EU Packaging and Packaging Waste Regulation: Why Life Sciences Companies Should Act Now</title><pubDate>Mon, 27 Jul 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{10EDE98B-8C44-4517-82DA-0DDAB69EA7A3}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/china-compliance-update-anti-corruption-summer-2026</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Siyi Gu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gu-siyi</a10:uri><a10:email>siyi.gu@cn.arnoldporter.com</a10:email></a10:author><title>China Compliance Update: Anti-Corruption — Summer 2026</title><description>Anti-corruption remained a top priority for Chinese authorities in the first half of 2026. Regulators issued the first major update to the official judicial interpretation of China&amp;rsquo;s criminal bribery framework in a decade, took further steps to implement the revised Anti-Unfair Competition Law (AUCL), and kept up a robust pace of anti-corruption enforcement.</description><pubDate>Fri, 24 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Anti-corruption remained a top priority for Chinese authorities in the first half of 2026. Regulators issued the first major update to the official judicial interpretation of China&amp;rsquo;s criminal bribery framework in a decade, took further steps to implement the revised Anti-Unfair Competition Law (AUCL), and kept up a robust pace of anti-corruption enforcement.&lt;/p&gt;
&lt;h2&gt;Legislative Updates&lt;/h2&gt;
&lt;h3&gt;New SPC/SPP Judicial Interpretation on Corruption and Bribery&lt;/h3&gt;
&lt;p&gt;On April 10, 2026, the Supreme People&amp;rsquo;s Court (SPC) and the Supreme People&amp;rsquo;s Procuratorate (SPP) jointly issued the &lt;a rel="noopener noreferrer" href="https://www.court.gov.cn/fabu/xiangqing/497181.html" target="_blank"&gt;Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery (II) (Interpretation (II)&lt;/a&gt;, 关于办理贪污贿赂刑事案件适用法律若干问题的解释（二）).[[N:&amp;nbsp;For further analysis of the Interpretation (II), see &lt;a href="/en/perspectives/advisories/2026/04/china-compliance-update-anti-corruption-spring-2026"&gt;China Compliance Update: Anti-Corruption &amp;mdash; Spring 2026&lt;/a&gt;.&amp;nbsp;]] It took effect on May 1, 2026, and is the first major update to the prior interpretation of the criminal law of bribery released by the SPC and SPP in a decade. It follows other recent changes to China&amp;rsquo;s anti-corruption rules, including amendments to the PRC Criminal Law, the AUCL, and the Supervision Law.&lt;/p&gt;
&lt;p&gt;The Interpretation (II) focuses on private-sector crimes and &amp;ldquo;entity crimes,&amp;rdquo; meaning crimes that carry liability for companies, public institutions, government agencies, and other organizations. Notably, the Interpretation (II) lowers the thresholds of bribery and corruption crimes for non-state functionaries[[N: &amp;ldquo;State functionaries&amp;rdquo; is a term referring not only to government officials, but which also includes other individuals who perform public duties in state-owned enterprises and public institutions. See Article 93 of the PRC Criminal Law.]] and revises the standards for entity crimes and key sectors. &lt;/p&gt;
&lt;h3&gt;SAMR Notice on Enforcement of the Revised AUCL&lt;/h3&gt;
&lt;p&gt;The revised AUCL took effect on October 15, 2025.[[N: For further analysis of the revised AUCL, see &lt;a href="/en/perspectives/advisories/2025/07/china-compliance-update-summer-2025"&gt;China Compliance Update &amp;mdash; Summer 2025&lt;/a&gt;]] Following that, the State Administration for Market Regulation (SAMR) issued the &lt;a rel="noopener noreferrer" href="https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/jjjzs/art/2026/art_84f7d42f9e474529bd4c369e84721300.html" target="_blank"&gt;Notice on Further Implementing the Anti-Unfair Competition Law of the People&amp;rsquo;s Republic of China&lt;/a&gt; (Notice, 市场监管总局关于进一步贯彻实施《中华人民共和国反不正当竞争法》的通知) to lower level Administrations for Market Regulation (AMR) on March 30, 2026. The Notice took immediate effect.&lt;/p&gt;
&lt;p&gt;The Notice provides guidance to AMRs on areas of emphasis when enforcing the revised AUCL, including an emphasis on investigating and punishing both the payment of bribes and the acceptance of bribes. This focus on both sides of corrupt transactions is an important change in the revised AUCL. The previous version of the AUCL did not explicitly prohibit accepting bribes and did not explicitly list administrative penalties for companies or individuals which accepted bribes, even though such conduct was, in practice, frequently the focus of enforcement actions. The revised AUCL filled this gap, bringing it in line with recent years&amp;rsquo; enforcement trends in China.&lt;/p&gt;
&lt;p&gt;Another key area of emphasis in the Notice is Article 40 of the revised AUCL, the &amp;ldquo;long-arm jurisdiction&amp;rdquo; clause. The Notice encouraged AMRs to explore the use of extraterritorial jurisdiction to target false advertising, online unfair competition, commercial defamation, trade secret misappropriation, and other misconduct outside of China that disrupts China&amp;rsquo;s market order or harms domestic rights holders, to safeguard the domestic supply chain and the interests of Chinese companies and the state. However, the SAMR has not provided further guidance on how extraterritorial jurisdiction should be exercised in the context of the revised AUCL. &lt;/p&gt;
&lt;p&gt;With the publication of the Notice, we anticipate more stringent enforcement actions targeting commercial bribery by the AMR, as well as efforts by local AMRs to implement extraterritorial jurisdiction. &lt;/p&gt;
&lt;h2&gt;Enforcement Cases&lt;/h2&gt;
&lt;p&gt;Official statistics released in the first half of 2026 confirm that Chinese regulators remained focused on anti-corruption enforcement.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/toutiaon/202604/t20260422_486590.html" target="_blank"&gt;In the first quarter of 2026&lt;/a&gt;, discipline inspection and supervisory commissions opened 245,000 cases and disciplined 183,000 people, including 56 provincial- or ministerial-level officials. In line with the principle of &amp;ldquo;investigating bribe givers and bribe takers together&amp;rdquo; (受贿行贿一起查), authorities opened investigations into 9,066 individuals suspected of paying bribes and referred 983 for prosecution.&lt;/p&gt;
&lt;p&gt;Three senior officials were investigated, arrested, or charged with crimes of bribery in the first half of 2026:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/toutiaon/202604/t20260430_488453.html" target="_blank"&gt;Huiman Yi&lt;/a&gt; (易会满), former Chairman of the China Securities Regulatory Commission (CSRC) from 2019 to 2024. On April 30, 2026, the Central Commission for Discipline Inspection (CCDI) announced that Yi was subject to disciplinary actions, including being expelled from the Communist Party and removed from any public duty, following a corruption investigation. In addition, Yi&amp;rsquo;s case has been transferred to the procuratorate for criminal charges. According to the CCDI, Yi abused his regulatory authority to seek benefits for others in matters including IPO approvals and financing activities, while accepting substantial bribes and allowing relatives to profit from his influence.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.spp.gov.cn/spp/qwfb/202603/t20260317_724127.shtml" target="_blank"&gt;Chaoliang Jiang&lt;/a&gt; (蒋超良), former Communist Party Secretary of Hubei Province. &lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/yaowenn/202510/t20251027_455162.html" target="_blank"&gt;Jiang was prosecuted for bribery and corruption&lt;/a&gt; on March 17, 2026. This investigation reaches back more than 30 years to Jiang&amp;rsquo;s time in the financial sector. He is accused of using his roles at the Agricultural Bank of China, China Development Bank, and the Hubei provincial government to provide improper help with loans, project approvals, and personnel decisions. The case has been publicly labeled &amp;ldquo;family-style corruption&amp;rdquo; (家族式腐败) because his relatives allegedly played a central role as conduits for concealed benefits.&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/toutiaon/202607/t20260714_501375.html" target="_blank"&gt;Xingrui Ma&lt;/a&gt; (马兴瑞), former Politburo member and Communist Party Secretary of Xinjiang Uygur Autonomous Region. On July 14, 2026, Ma was expelled from the Communist Party and removed from public office following a corruption investigation. The CCDI found him to have abused his position to benefit others in business operations, engineering projects, and personnel matters in exchange for substantial bribes, while allowing relatives to exploit his influence for personal gain. Ma&amp;rsquo;s case has been referred for criminal prosecution.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These cases illustrate Chinese regulators&amp;rsquo; continued emphasis on scrutinizing officials&amp;rsquo; family members in 2026. This has been the enforcement focus of bribery and corruption by government and party officials in recent years, particularly since the issuance of the Report at the 20th National Congress of the Communist Party of China in October 2022, which explicitly required enhanced scrutiny over corruption cases involving officials&amp;rsquo; family members, including their spouses, children, and other relatives. &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E10A5876-6D93-4EE7-82B7-45B5C3E5B832}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/07/oversight-risks-from-the-next-congress-what-to-expect-and-what-companies-should-do-now</link><a10:author><a10:name>Rachel F. Cotton</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cotton-rachel-f</a10:uri><a10:email>rachel.cotton@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mark Epley</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/epley-mark</a10:uri><a10:email>mark.epley@arnoldporter.com</a10:email></a10:author><title>Oversight Risks from the Next Congress: What to Expect and What Companies Should Do Now</title><description>The next Congress could bring dramatic changes to oversight priorities, investigative targets, and political scrutiny.</description><pubDate>Thu, 23 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The next Congress could bring dramatic changes to oversight priorities, investigative targets, and political scrutiny. Join the bipartisan leaders of Arnold &amp;amp; Porter&amp;rsquo;s congressional investigations practice, Rachel Cotton and Mark Epley, alongside Michael Czin and Jill Zuckman of leading public affairs firm SKDK, for a timely look at the oversight risks ahead&amp;mdash;and the steps organizations should take to be prepared.&lt;/p&gt;
&lt;h2&gt;Speakers&lt;/h2&gt;
&lt;p&gt;Rachel Cotton and Mark Epley co-lead Arnold &amp;amp; Porter&amp;rsquo;s bipartisan congressional investigations practice. Rachel draws on her experience in senior Executive Branch legal roles, including in the White House Counsel&amp;rsquo;s Office, to advise companies and executives facing high-profile government scrutiny and investigations. Mark brings more than two decades of experience leading congressional investigations and oversight matters, helping clients navigate complex inquiries, crisis situations, and significant legal, political, and reputational risks.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://skdknick.com/about/people/jill-zuckman/" target="_blank"&gt;Jill Zuckman&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://skdknick.com/about/people/michael-czin/" target="_blank"&gt;Michael Czin&lt;/a&gt; co-lead SKDK&amp;rsquo;s investigations and oversight practice. Jill has more than two decades of experience as a national political reporter, senior government official, and advisor to leading companies. Michael works at the intersection of politics, policy, and investigations, supporting CEOs and boards navigating complex, long-term investigations in a range of fields.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{266FBD0A-624B-46D5-97E3-C2EECC5776CC}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/chambers-high-net-worth-2026-recognizes-arnold-porters-lawyers-and-private-client-services</link><title>Chambers High Net Worth 2026 Recognizes Arnold Porters Lawyers and Private Client Services</title><description>The 2026 edition of &lt;em&gt;Chambers High Net Worth&lt;/em&gt; recognized Arnold &amp;amp; Porter&amp;rsquo;s private wealth law capabilities and ranked three of its lawyers. The guide highlights the top lawyers and law firms working with the international private wealth market.</description><pubDate>Thu, 23 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 2026 edition of &lt;em&gt;Chambers High Net Worth&lt;/em&gt; recognized Arnold &amp;amp; Porter&amp;rsquo;s private wealth law capabilities and ranked three of its lawyers. The guide highlights the top lawyers and law firms working with the international private wealth market.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Chambers High Net Worth&lt;/em&gt; 2026 ranked the firm&amp;rsquo;s Private Client Services practice in the area of D.C. Private Wealth Law, noting the firm is distinguished by its &amp;ldquo;caliber of its partners&amp;rdquo; and their ability to &amp;ldquo;resolve complex estate issues to maximize the most favorable outcomes&amp;rdquo; for their clients.&lt;/p&gt;
&lt;p&gt;In addition to the practice ranking, &lt;em&gt;Chambers High Net Worth&lt;/em&gt; 2026 also recognized the following lawyers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Sarah Constantine&amp;mdash;Private Wealth Law (New York)&lt;/li&gt;
    &lt;li&gt;Cara Koss&amp;mdash;Private Wealth Law (D.C.)&lt;/li&gt;
    &lt;li&gt;Thomas Richardson&amp;mdash;Private Wealth Law (D.C.); Private Wealth Law: Eastern Region (Nationwide)&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{4E4D5984-E148-45CA-B6BC-4BF4C0C20981}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/colorado-narrows-its-ai-law-but-the-ftc-says-thats-not-enough</link><a10:author><a10:name>Sheena Thomas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomas-sheena</a10:uri><a10:email>sheena.thomas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alyssa T. Calcerano</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/calcerano-alyssa</a10:uri><a10:email>alyssa.calcerano@arnoldporter.com</a10:email></a10:author><title>Colorado Narrows Its AI Law, but the FTC Says That’s Not Enough: What Should Companies Make of These Changes?</title><description>&lt;p&gt;Colorado has significantly scaled back its pioneering artificial intelligence (AI) law, replacing its original, risk-management-focused framework with a more streamlined, disclosure-based approach that takes effect January 1, 2027, while broader state AI regulation continues to evolve in different directions. Although the revised law reduces compliance burdens by eliminating mandatory impact assessments and risk management programs, it still imposes important notice, transparency, and human-review obligations for businesses using automated decision-making tools in areas such as employment, lending, healthcare, insurance, and education. At the same time, the Federal Trade Commission has suggested the law may be preempted by federal law, creating additional uncertainty and making it essential for companies to prepare for compliance while closely monitoring forthcoming rulemaking and federal developments.&lt;/p&gt;</description><pubDate>Thu, 23 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;&lt;span&gt;
&lt;p&gt;Artificial intelligence (AI) regulation is fragmenting. In recent years, several states, including Utah, Texas, Virginia, and Connecticut, have passed first-of-their-kind AI laws. Some have since narrowed those original laws, while others have blocked or expanded them. In May, Colorado joined the states that have scaled back, dramatically narrowing its approach by replacing its original AI law, SB 24-205, with a lighter disclosure-focused framework, SB 26-189, weeks before that original AI act was set to take effect on June 30, 2026. Adding to the complexity, the Federal Trade Commission (FTC) recently issued a proposed policy statement suggesting that even Colorado&amp;rsquo;s scaled-back law may be preempted by federal law, creating uncertainty for businesses planning their compliance approach. This Advisory analyzes Colorado&amp;rsquo;s pivot and offers practical guidance for businesses navigating the new law. Companies using automated tools for high-risk decisions (employment, lending, insurance, healthcare, or education) should assess their compliance obligations under these emerging state laws. Those serving Colorado consumers should prioritize near-term compliance planning, as should any company using such tools in employment decisions, given the overlap with Connecticut and other emerging state laws.&lt;/p&gt;
&lt;h2&gt;What Did Colorado&amp;rsquo;s Original AI Statute Require?&lt;/h2&gt;
&lt;p&gt;In 2024, Colorado enacted comprehensive legislation targeting &amp;ldquo;high-risk artificial intelligence systems,&amp;rdquo; defined as &amp;ldquo;any artificial intelligence system that, when deployed, makes or is a substantial factor in making, a consequential decision.&amp;rdquo;[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(9)(a)) (repealed 2026).]]&lt;/p&gt;
&lt;p&gt;Specifically, SB 24-205 imposed duties on deployers (companies that use AI systems) and developers (companies that create those AI systems), including a duty to avoid &amp;ldquo;algorithmic discrimination&amp;rdquo; and to disclose the use of AI systems to consumers.[[N:Id. &amp;sect;&amp;sect; 6-1-1702, 6-1-1703, 6-1-1704 (repealed 2026).]] To avoid such discrimination, deployers of high-risk AI systems were required to implement a risk management policy to govern deployment of the system and complete a detailed impact assessment.[[N:Id. &amp;sect;&amp;sect; 6-1-1703(2)(a)(I)(A), (3) (repealed 2026). The impact assessment was required to include, among other things, the intended use cases for the AI system, the reasonably foreseeable risks of such discrimination, the categories of data it would process, an overview of the categories of data used, its known limitations, a description of any transparency measures, and a description of &amp;ldquo;post-deployment monitoring and user safeguards.&amp;rdquo; Id. &amp;sect; 6-1-1703(3)(a)-(b) (repealed 2026).]]&lt;/p&gt;
&lt;p&gt;SB 24-205 required deployers to notify consumers before a high-risk AI system was used to make a &amp;ldquo;consequential decision.&amp;rdquo;[[N:S.B. 24-205 &amp;sect; 1 (to be codified at Colo. Rev. Stat. &amp;sect; 6-1-1703(4)(a)(I)) (repealed 2026).]] That notice had to include the purpose for using the system, the nature of the decision, and information about the consumer&amp;rsquo;s right to opt out of profiling.[[N:Id. &amp;sect; 6-1-1703(4)(a) (repealed 2026).]] The law also imposed a post-hoc disclosure requirement: deployers had to explain the decision-making process for any consequential decisions made using high-risk AI systems.[[N:Id. &amp;sect; 6-1-1703(4)(b)(I)(A)-(C) (repealed 2026).]]&lt;/p&gt;
&lt;h2&gt;Why Did Colorado Replace the Original AI Statute?&lt;/h2&gt;
&lt;p&gt;SB 24-205 was originally scheduled to take effect February 1, 2026.[[N:See S.B. 24-205 (repealed 2026).]] However, the law faced criticism from industry, and efforts to amend it during the 2025 regular session stalled.[[N:Marianne Goodland, &lt;a rel="noopener noreferrer" href="https://www.coloradopolitics.com/2025/10/15/gov-polis-convenes-new-working-group-to-address-colorados-lingering-ai-law-challenges/" target="_blank"&gt;Gov. Polis convenes new working group to address Colorado&amp;rsquo;s lingering AI law challenges&lt;/a&gt;, Colo. Pol. (Oct. 15, 2025).]] Governor Polis called a special legislative session in August 2025 to force a resolution before the February deadline, but similar criticism stalled each of the proposed bills.[[N:Id.]] Days before the special session closed, Senate Majority Leader Robert Rodriguez proposed a delay, pushing the effective date to June 30, 2026.[[N:Id.; S.B. 25B-004, 75th Gen. Assemb., 1st Extraordinary Sess. (Colo. 2025).]]&lt;/p&gt;
&lt;p&gt;That failed special session prompted the Colorado AI Policy Work Group (Work Group), a stakeholder body of industry representatives, consumer advocates, hospitals, school districts, and technology companies convened by Governor Polis, to negotiate a full policy framework built around the new June 30 deadline.[[N:See Goodland, &lt;em&gt;supra&lt;/em&gt; note 8.]]&lt;/p&gt;
&lt;p&gt;Those negotiations played out against a backdrop of federal pressure, including a December 2025 executive order critical of state algorithmic-discrimination laws and a federal lawsuit challenging SB 24-205 on constitutional grounds.[[N:Office of Public Affairs, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-intervenes-xai-lawsuit-challenging-colorados-algorithmic-discrimination" target="_blank"&gt;Justice Department Intervenes in xAI Lawsuit Challenging Colorado&amp;rsquo;s &amp;lsquo;Algorithmic Discrimination&amp;rsquo; Law&lt;/a&gt;, U.S. Dep&amp;rsquo;t of Justice (Apr. 24, 2026).]] The lawsuit resulted in a stay of enforcement (not on the merits, but because the law was likely to be superseded by the Work Group&amp;rsquo;s proposed bill), which became the basis for SB 26-189.&lt;/p&gt;
&lt;p&gt;Colorado&amp;rsquo;s shift was part of a broader pattern of state-level AI regulation. California set the early baseline for automated decision-making technology (ADMT)-specific regulation, having adopted detailed rules governing ADMT under the California Consumer Privacy Act in 2025.[[N:Cal. Code Regs. tit. 11, art. 11 (2025).]]&lt;/p&gt;
&lt;p&gt;However, several states have recently scaled back or blocked AI legislation: Utah amended its Artificial Intelligence Policy Act in 2025 to narrow disclosure requirements and add a safe harbor for companies following recognized compliance frameworks;[[N:S.B. 149, 2024 Gen. Sess. (Utah 2024); S.B. 226, S.B. 332, H.B. 452, S.B. 271 (all amending the UAIPA).]] Texas softened its original AI law by requiring both intent and adverse outcome for discrimination claims;[[N:&lt;em&gt;Compare&lt;/em&gt; H.B. 149, 89th Leg., Reg. Sess. (Tex. 2025) &lt;em&gt;with&lt;/em&gt; H.B. 1709, 89th Leg., Reg. Sess. (Tex. 2025).]] and Virginia&amp;rsquo;s governor vetoed that state&amp;rsquo;s AI bill in March 2025, calling it &amp;ldquo;burdensome&amp;rdquo; to the industry.[[N:Va. Legis. Info. Sys., &lt;a rel="noopener noreferrer" href="https://lis.virginia.gov/bill-details/20251/HB2094/text/HB2094VG" target="_blank"&gt;Governor&amp;rsquo;s Veto&lt;/a&gt;; Dean Mirshahi, &lt;a rel="noopener noreferrer" href="https://www.vpm.org/generalassembly/2026-02-23/virginia-ai-bills-hayes-maldonado-salim-trump-spanberger" target="_blank"&gt;Most artificial intelligence legislation in Virginia was tabled until 2027&lt;/a&gt;, VPM (Feb. 23, 2026, 5:10 PM EST).]] &lt;/p&gt;
&lt;p&gt;Diverging from the trend, Connecticut passed the Connecticut Artificial Intelligence Responsibility and Transparency Act, focusing on regulation of AI use for employment decisions.[[N:An Act Concerning Online Safety, 2026 Conn. Pub. Acts 26-15 (codification pending) (originally introduced as Substitute S.B. 5, 2026 Gen. Assemb., Reg. Sess. (Conn. 2026)).]] The act amends the state&amp;rsquo;s anti-discrimination statute to preclude ADMT use as a defense to employment discrimination claims and make available proactive anti-bias testing as a mitigating factor for courts to consider.[[N:2026 Conn. Pub. Acts 26-15.]] It also creates whistleblower protections for employees of frontier developers, regulates AI chatbots, and requires content provenance markers on AI-generated media.[[N:Id.]]&lt;/p&gt;
&lt;h2&gt;How Does the Colorado Revised Act Differ From the Original?&lt;/h2&gt;
&lt;p&gt;&lt;strong&gt;Covered Technologies&lt;/strong&gt;: SB 26-189 redefines the universe of covered technology. SB 24-205 covered &amp;ldquo;high-risk artificial intelligence systems,&amp;rdquo; defined as any AI system that, when deployed, makes or is a substantial factor in making, a consequential decision.[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(9)(a)) (repealed 2026).]] SB 26-189 instead applies to &amp;ldquo;covered&amp;rdquo; ADMT, defined as automated decision-making technology that processes personal data and is used to materially influence a consequential decision.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(2)(a), (5)).]] While &amp;ldquo;artificial intelligence systems&amp;rdquo; was defined specifically as &amp;ldquo;machine-based system[s] that &amp;hellip; infer[] from the inputs &amp;hellip; receive[d] how to generate outputs,&amp;rdquo; ADMT is broadly defined as &amp;ldquo;a technology that processes personal data and uses computation to generate output.&amp;rdquo;[[N:&lt;em&gt;Compare&lt;/em&gt; S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(2)) (repealed 2026) &lt;em&gt;with&lt;/em&gt; S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(2)(a)).]] Thus, a broader range of technologies is now covered by the law.&lt;/p&gt;
&lt;p&gt;However, the universe of covered decisions is narrower: SB 26-189 limits &amp;ldquo;consequential decisions&amp;rdquo; to seven &amp;ldquo;covered domains&amp;rdquo; (education, employment, residential real estate, financial or lending services, insurance, healthcare, and essential government services), dropping legal services, which SB 24-205 included.[[N:&lt;em&gt;Compare&lt;/em&gt; S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(3)) (repealed 2026) &lt;em&gt;with&lt;/em&gt; S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(6)).]]&lt;/p&gt;
&lt;p&gt;Additionally, SB 26-189 exempts ADMT used for low-stakes or routine decisions, advertising and marketing, spreadsheets that require human analysis, procedural tasks, cybersecurity and privacy tasks, administration, fraud prevention, and others.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1701(2)(b)).]] These use exemptions are similar to those in California&amp;rsquo;s 2025 ADMT regulations.[[N:See Cal. Code Regs. tit. 11, art. 1 &amp;sect; 7001(e)(3) (2025) (exempting from the definition of ADMT &amp;ldquo;web hosting, domain registration, networking, caching, website-loading, data storage, firewalls, anti-virus, anti-malware, spam- and robocall-filtering, spellchecking, calculators, databases, and spreadsheets, provided that they do not replace human decisionmaking&amp;rdquo;).]] Still, absent further developments, any company using ADMT in hiring and employment decisions, regardless of industry or service, should consider its plan for compliance with the new law.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Algorithmic Discrimination&lt;/strong&gt;: Rather than imposing a duty to avoid &amp;ldquo;algorithmic discrimination,&amp;rdquo; SB 26-189 instead provides that existing state discrimination laws, such as the Colorado Anti-Discrimination Act, apply to regulated uses of ADMT.[[N:&lt;em&gt;Compare&lt;/em&gt; S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1702) (repealed 2026) &lt;em&gt;with&lt;/em&gt; S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1707(1)).]] Deployers are no longer required to implement a detailed risk management policy or complete a lengthy impact assessment.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Developer Obligations&lt;/strong&gt;: AI developers must provide deployers with (1) the intended and harmful or inappropriate uses of the technology; (2) a description of the categories of data used to train the technology; (3) limitations, risks and circumstances in which deployers should not use the technology; (4) instructions for appropriate use and information necessary for deployers to comply with the law; and (5) notice of updates and modifications.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1702(1), (2)(a)).]] This is less extensive than SB 24-205, which additionally required developers to furnish deployers with documentation of known or foreseeable risks of algorithmic discrimination and a summary of the data governance measures used in developing the system.[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1702(2)(b)(II), (c)(II)) (repealed 2026).]]&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Deployer Obligations&lt;/strong&gt;: Requirements for companies that deploy ADMT focus on anticipating and responding to adverse outcomes that consumers may experience as a result of ADMT decisions.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1704(3)).]] Deployers must give consumers notice before using ADMT for consequential decisions.[[N:Id. &amp;sect; 6-1-1704(1).]] If a consumer experiences an adverse outcome from a decision in which ADMT played a role, the deployer must disclose the consumer&amp;rsquo;s right to request personal data, correct inaccurate data, and obtain human review of the decision.[[N:Id. &amp;sect; 6-1-1704(3).]] SB 24-205&amp;rsquo;s deployer obligations were considerably more involved: deployers had to complete a pre-deployment impact assessment, adopt and maintain a written risk management policy, and, in some cases, complete annual reviews of the system&amp;rsquo;s performance.[[N:See generally S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1703).]] SB 26-189 eliminates all three requirements, imposing on deployers a more limited, disclosure-driven compliance program built around notice and post-outcome transparency rather than ongoing risk management.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Consumer Rights&lt;/strong&gt;: A consumer who experiences an adverse outcome as a result of an ADMT-driven consequential decision has the right to request personal data, correct inaccurate data, and obtain human review and reconsideration of the decision.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1705(1)(a)(I)-(II)).]] SB 24-205 similarly required deployers to provide consumers an opportunity to correct personal data;[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1703(4)(b)(II)) (repealed 2026).]] however, SB 24-205 was broader when it came to consumer access to their personal data. Beyond simply being granted the ability to request &amp;ldquo;instructions for requesting personal data,&amp;rdquo;[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1705(1)(a)(I)).]] SB 24-205 required deployers to automatically &amp;ldquo;provide to the consumer &amp;hellip; [t]he type of data that was processed.&amp;rdquo;[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1703(4)(b)(I)(B)) (repealed 2026).]] These consumer rights are similar to those that California created, but California goes further, requiring businesses to give consumers the ability to opt out of ADMT.[[N:Cal. Code Regs. tit. 11, &amp;sect; 7221 (2025).]]&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Liability&lt;/strong&gt;: SB 26-189 imposes liability on developers or deployers for unlawful discrimination under Colorado&amp;rsquo;s Anti-Discrimination Act for regulated uses of covered ADMT.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect;&amp;sect; 6-1-1707(1)).]] However, developers cannot be held liable for a deployer&amp;rsquo;s &lt;em&gt;unintended&lt;/em&gt; use of the ADMT that results in a discriminatory decision.[[N:Id. &amp;sect; 6-1-1707(5)(b).]] The statute also allocates fault between developers and deployers based on their relative responsibility for a violation, rather than imposing automatic joint liability, and voids any contract provision that purports to indemnify a party against liability for its own discriminatory use of ADMT.[[N:Id. &amp;sect; 6-1-1707(2), (4), (7)(a).]]&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Litigation and Enforcement&lt;/strong&gt;: The law does not create a private right of action. Instead, it provides for enforcement by the Attorney General under the Colorado Consumer Protection Act.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect;&amp;sect; 6-1-1706, 6-1-1709).]] On this point, SB 26-189 preserves SB 24-205&amp;rsquo;s approach: both[[N:S.B. 24-205 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1706) (repealed 2026).]] versions of the law leave enforcement exclusively to the Attorney General.&lt;/p&gt;
&lt;p&gt;The law provides for a notice-and-cure period of 60 days, but if a deployer or developer knowingly or repeatedly violates the provisions, the Attorney General is not required to provide notice or time for cure.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect;&amp;sect; 6-1-1706(3)(b), (c)).]]&lt;/p&gt;
&lt;p&gt;The months leading up to the law taking effect on January 1, 2027 will be instructive. The Attorney General is expected to adopt rules clarifying the requirements and issue guidance about how the law will apply to different sectors and domains.[[N:Id. &amp;sect; 6-1-1706(5).]] Deployers will need to monitor the rulemaking to understand their compliance obligations.&lt;/p&gt;
&lt;h2&gt;How Has the FTC Responded to SB 26-189?&lt;/h2&gt;
&lt;p&gt;In early July, just over one month after the Revised Act&amp;rsquo;s passage, the FTC issued a Proposed Policy Statement Concerning the Suppression of Accuracy in Artificial Intelligence Systems.[[N:FTC, &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/ai-policy-statement_0.pdf" target="_blank"&gt;Federal Trade Commission&amp;rsquo;s Proposed Policy Statement Concerning The Suppression Of Accuracy In Artificial Intelligence Systems&lt;/a&gt; (July 1, 2026).]] The Proposed Policy Statement warns against a &amp;ldquo;balkanized or patchwork regulatory approach&amp;rdquo; and cites Colorado&amp;rsquo;s original AI statute as an example of state regulators &amp;ldquo;requiring American companies to embed ideological bias within their AI models.&amp;rdquo;[[N:Id.]] While the Proposed Policy Statement acknowledges the changes made in SB 26-189, it states that even &amp;ldquo;the new version poses many of the same concerns&amp;rdquo; as Colorado&amp;rsquo;s original act and may be preempted by Section 5 of the FTC Act.[[N:Id.]] The Proposed Policy Statement cites SB 26-189&amp;rsquo;s liability provisions as applying &amp;ldquo;pressure&amp;rdquo; on AI developers to &amp;ldquo;alter&amp;rdquo; model outputs in ways that may themselves violate Section 5.[[N:Id.]]&lt;/p&gt;
&lt;p&gt;The FTC is currently seeking comment on the Proposed Policy Statement until July 31, 2026.[[N:FTC, &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/07/ftc-seeks-public-comment-policy-statement-addressing-ai-accuracy" target="_blank"&gt;FTC Seeks Public Comment on Policy Statement Addressing AI Accuracy&lt;/a&gt; (July 1, 2026).]]&lt;/p&gt;
&lt;h2&gt;Practical Guidance for Navigating These AI Laws&lt;/h2&gt;
&lt;p&gt;It will be crucial that companies adopt compliance measures as soon as possible in the covered areas. This is especially important because the 60-day notice-and-cure provision will not apply to developers or deployers who knowingly violate the law or ignore potential violations. Violators risk incurring penalties of up to $20,000 per violation.[[N:S.B. 26-189 &amp;sect; 1 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1706(3)(c)); see S.B. 26-189 &amp;sect; 2 (&lt;em&gt;to be codified at&lt;/em&gt; Colo. Rev. Stat. &amp;sect; 6-1-1705(1)(uuuu)) (deeming violation of the Colorado AI Act an unfair or deceptive trade practice); Colo. Rev. Stat. &amp;sect; 6-1-112(1)(a) (providing that violations will result in fines of up to $20,000).]]&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Below are a few compliance obligations that businesses should focus on in the near term.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Compliance obligations for deployers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Deployers should prepare for compliance with the new consumer rights provisions&lt;/strong&gt;. Deployers (that is, all businesses using ADMT to provide services in any of the covered domains, as well as any business using ADMT in employment decisions regardless of industry) bear the onus of complying with SB 26-189&amp;rsquo;s new consumer rights provisions. When a consumer experiences an adverse outcome from an ADMT-driven decision, deployers must have in place processes for handling consumer data access and correction requests.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Deployers should start with an ADMT inventory and prioritize employment&lt;/strong&gt;. Before drafting any disclosures, deployers should map every system that touches a covered domain (not just AI marketed as &amp;ldquo;AI&amp;rdquo;) since SB 26-189&amp;rsquo;s technology-neutral definition can sweep in conventional scoring tools and rules-based systems that a narrower, AI-specific definition might have missed. Employment decisions deserve particular attention regardless of industry: it is the one domain where Colorado and Connecticut (among other states) overlap.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Deployers should build the required notice, disclosure, and human-review workflows&lt;/strong&gt;. Because SB 26-189 dropped the risk-assessment and audit obligations of Colorado&amp;rsquo;s original AI law in favor of a disclosure-driven model, the practical work ahead should focus on operational infrastructure: notices to consumers before using ADMT and templates for disclosing adverse-outcome rights. Companies with existing state privacy compliance programs may be able to adapt those frameworks to address some of these requirements, though the human-review requirement and adverse-outcome disclosure triggers are new. Businesses should also identify candidates who will serve as human reviewers of adverse decisions.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Compliance obligations for developers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Developers should document intended use, and be prepared to explain any changes to model outputs&lt;/strong&gt;. Because SB 26-189 shields developers from liability for a deployer&amp;rsquo;s unintended or out-of-scope use of their technology, a developer&amp;rsquo;s own documentation of intended and inappropriate uses will be critical in avoiding liability for unintended uses. Given the FTC&amp;rsquo;s stated concern that developers may be tempted to quietly alter model outputs to avoid liability under laws like SB 26-189, developers should also be able to show that any changes to a model&amp;rsquo;s outputs were made for disclosed, legitimate reasons, rather than as an undisclosed attempt to route around Colorado&amp;rsquo;s law in a way that could itself raise Section 5 exposure.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Compliance obligations for both deployers and developers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Deployers and developers alike should track the Attorney General&amp;rsquo;s rulemaking&lt;/strong&gt;. Much of SB 26-189&amp;rsquo;s practical scope (what counts as &amp;ldquo;materially influencing&amp;rdquo; a decision, what a compliant adverse-outcome disclosure looks like, etc.) is expected to be filled in by rulemaking before the January 1, 2027 effective date. Because the rulemaking will fill in key details, deployers with significant Colorado exposure may benefit from participating in the comment process.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Ultimately, the FTC&amp;rsquo;s position that SB 26-189 may be preempted by federal law puts Colorado&amp;rsquo;s AI statute in a state of uncertainty and leaves developers to navigate how to satisfy SB 26-189&amp;rsquo;s disclosure and liability provisions without running afoul of Section 5. Until that tension resolves (whether through the FTC&amp;rsquo;s final policy statement, litigation, or further legislative action), developers and deployers servicing Colorado consumers can still expect to be subject to SB 26-189&amp;rsquo;s requirements starting on January 1, 2027.&lt;/p&gt;
&lt;p&gt;* Maria Duque contributed to this Advisory. Maria is a summer associate in Arnold &amp;amp; Porter&amp;rsquo;s Chicago office.&lt;/p&gt;
&lt;/span&gt;&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{011A9614-2EA5-45B7-9C9C-985BA95173DB}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/07/taking-buy-local-to-the-next-level-supply-chain-developments-in-life-sciences</link><a10:author><a10:name>Lynn Fischer Fox</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fischer-fox-lynn</a10:uri><a10:email>lynn.fischerfox@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kristen E. Ittig</a10:name><a10:uri>https://www.arnoldporter.com/en/people/i/ittig-kristen-e</a10:uri><a10:email>kristen.ittig@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Howard Sklamberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sklamberg-howard</a10:uri><a10:email>howard.sklamberg@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Elizabeth Trentacost</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trentacost-elizabeth</a10:uri><a10:email>elizabeth.trentacost@arnoldporter.com</a10:email></a10:author><title>Part III: Taking Buy Local to the Next Level: Supply Chain Developments in Life Sciences</title><description>Traditional government contractors have long known that the integrity of the supply chain for the U.S. industrial base is a crucial national security issue.</description><pubDate>Wed, 22 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Traditional government contractors have long known that the integrity of the supply chain for the U.S. industrial base is a crucial national security issue. As this program will explore, accelerating efforts to strengthen and onshore pharmaceutical supply chains have become a critical part of the Administration&amp;rsquo;s push for economic sovereignty and highlight the importance of this issue in the life sciences space. The effort to build the domestic supply chain could have unexpected consequences for allied countries.&lt;/p&gt;
&lt;p&gt;Recent trade, regulatory, and industrial policy developments all point to an increased focus on the expansion of domestic manufacturing capacity. While the Acetris decision somewhat loosened Trade Agreements Act requirements, recent procurement trends indicate heightened interest in disclosure of the origin on ingredients, perhaps leading to increased demand for U.S.-origin components and end products. This marries up with the Administration&amp;rsquo;s Section 232 investigations, which are examining the effects on national security of pharmaceuticals and their ingredients. Related tariff proposals and most-favored-nation (MFN) deals for patented pharmaceuticals and active pharmaceutical ingredients (APIs) have heightened focus on supply chain resiliency and domestic production. At the same time, exemptions for generic drugs, biosimilars, and certain 505(b)(2) products&amp;mdash;and a planned reassessment by the Department of Commerce&amp;mdash;raise important questions about the future of pharmaceutical manufacturing policy. Meanwhile, negotiations surrounding the reauthorization of the Generic Drug User Fee Amendments (GDUFA IV) and Prescription Drug User Fee Act (PDUFA VIII) may introduce new incentives and considerations relating to manufacturing location, supply chain security, and clinical development.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter will discuss key developments shaping pharmaceutical supply chains and onshoring strategies, including U.S. and EU efforts to bolster production of essential medicines, the intersection of trade and regulatory policy, and the potential implications of user fee reauthorization negotiations for manufacturers, product developers, and other supply chain stakeholders.&lt;/p&gt;
&lt;h2&gt;Speakers&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;Lynn Fischer Fox | Partner and former Deputy Assistant Secretary with the Department of Commerce&lt;/li&gt;
    &lt;li&gt;Kristen Ittig | Partner, Government Contracts and National Security&lt;/li&gt;
    &lt;li&gt;Alexander Roussanov | Partner and former Legal Advisor at EMA&lt;/li&gt;
    &lt;li&gt;Howard Sklamberg | Partner and former Deputy Commissioner for Global Regulatory at FDA&lt;/li&gt;
    &lt;li&gt;Elizabeth Trentacost | Senior Associate and former Regulatory Counsel at FDA&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;We invite you to join us and to come with questions! &lt;/p&gt;
&lt;h4&gt;&lt;strong&gt;Save the Date&lt;/strong&gt;&lt;/h4&gt;
&lt;strong&gt;Part IV: Complying with Export Controls and Trade Sanctions&lt;/strong&gt;&lt;br /&gt;
Wednesday, October 21&lt;br /&gt;
11 a.m.-noon ET&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;Speakers&lt;/strong&gt;: John Barker, Eun Young Choi, and Alexander Italianer&lt;br /&gt;
&lt;br /&gt;</a10:content></item><item><guid isPermaLink="false">{FA7D6E2F-4D7C-437E-B180-09BE00BDDD1D}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/eva-temkin-discusses-fdas-complete-response-letter-transparency-policy-in-biospace</link><title>Eva Temkin Discusses FDA’s Complete Response Letter Transparency Policy in BioSpace</title><description>Eva Temkin, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)'s Office of Therapeutic Biologics and Biosimilars, was quoted in the &lt;em&gt;BioSpace &lt;/em&gt;article, "FDA's radical transparency policy for rejections runs into legal uncertainty," which examines the legal and regulatory questions surrounding the FDA's policy of publishing complete response letters (CRLs) for unapproved drug applications.</description><pubDate>Wed, 22 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Eva Temkin, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)'s Office of Therapeutic Biologics and Biosimilars, was quoted in the &lt;em&gt;BioSpace&lt;/em&gt; article, "FDA's radical transparency policy for rejections runs into legal uncertainty," which examines the legal and regulatory questions surrounding the FDA's policy of publishing complete response letters (CRLs) for unapproved drug applications.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Addressing the FDA's current approach, Eva cautioned that the agency's policy shift raises complex legal and regulatory issues that have not been adequately vetted through the public rulemaking process. "I'm not sure the new policy is right," she said, explaining that the change "was premised on a very narrow view of the way this policy would impact drug development and, hence, patient access."&lt;/p&gt;
&lt;p&gt;Eva also welcomed the FDA's decision to pursue formal rulemaking, noting that stakeholders should have the opportunity to provide meaningful input before the policy moves forward. While observing that "it's likely too late to put the proverbial toothpaste back in the tube," she urged the agency to pause implementation of the CRL publication policy until it "receives feedback, considers that feedback and finalizes the rule accordingly."&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.biospace.com/fda/fdas-radical-transparency-policy-for-rejections-runs-into-legal-uncertainty"&gt;Read the full article.&lt;/a&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{50AD5C6A-A060-40B6-8E74-6A819DD1E3CB}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/howard-sklamberg-discusses-fda-oversight-of-peptides-on-npr</link><title>Howard Sklamberg Discusses FDA Oversight of Peptides on NPR</title><description>Howard Sklamberg, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), recently spoke with &lt;em&gt;NPR&amp;rsquo;s Short Wave&lt;/em&gt; to discuss the regulatory challenges surrounding the expanding market for peptide products.</description><pubDate>Wed, 22 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Howard Sklamberg, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), recently spoke with &lt;em&gt;NPR&amp;rsquo;s Short Wave&lt;/em&gt; to discuss the regulatory challenges surrounding the expanding market for peptide products.&lt;/p&gt;
&lt;p&gt;The hosts explained that while peptides hold scientific promise, many products marketed for anti-aging, recovery, and performance enhancement have not undergone the rigorous clinical testing required for FDA approval.&lt;/p&gt;
&lt;p&gt;Howard cautioned that the broad availability of compounded and unapproved peptides could discourage investment in the clinical trials needed to develop approved therapies, while also posing a public health threat. &amp;ldquo;The FDA is always pulled between a public health impulse and a more libertarian impulse,&amp;rdquo; he said, noting that the FDA's regulatory framework is intended to protect patients while ensuring innovation is supported by reliable scientific evidence.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://podcasts.apple.com/us/podcast/does-the-science-of-peptides-live-up-to-the-hype/id1482575855?i=1000777798327"&gt;Listen to the full interview.&lt;/a&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A3F54E5F-D079-46A3-9719-CE4D2EA06887}</guid><link>https://www.biosliceblog.com/2026/07/edpb-guidelines-on-anonymisation-what-life-sciences-companies-need-to-know/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jami Vibbert</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vibbert-jami</a10:uri><a10:email>jami.vibbert@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Camille Vermosen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vermosen-camille</a10:uri><a10:email>camille.vermosen@arnoldporter.com</a10:email></a10:author><title>EDPB Guidelines on Anonymisation: What Life Sciences Companies Need to Know</title><pubDate>Tue, 21 Jul 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{702409AF-6F47-44D2-95A3-3C11ADBBDA67}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-shortlisted-for-14-awards-at-2026-lmg-life-sciences-americas-awards</link><title>Arnold &amp; Porter Shortlisted for 14 Awards at 2026 LMG Life Sciences Americas Awards</title><description>Arnold &amp;amp; Porter has been shortlisted for 14 awards at the 2026 &lt;em&gt;LMG Life Sciences Americas&lt;/em&gt; Awards, which recognize the region&amp;rsquo;s most distinguished practitioners and their firms for their exemplary work in the Life Sciences legal practice over the past year.&amp;nbsp;</description><pubDate>Mon, 20 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has been shortlisted for 14 awards at the &lt;a rel="noopener noreferrer" href="https://www.managingip.com/article/2gmrqoytrqemj2zwv1ukg/managing-ip-awards/life-sciences-awards-americas-2026-shortlist-revealed" target="_blank"&gt;2026 &lt;em&gt;LMG Life Sciences Americas &lt;/em&gt;Awards&lt;/a&gt;, which recognize the region&amp;rsquo;s most distinguished practitioners and their firms for their exemplary work in the Life Sciences legal practice over the past year. Following extensive research and submission evaluations, the annual ceremony will recognize significant cases and deals, along with the legal professionals and firms involved.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has been shortlisted in the following &amp;ldquo;Firm of the Year&amp;rdquo; categories:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Antitrust Firm of the Year&lt;/li&gt;
    &lt;li&gt;FDA Litigation &amp;amp; Enforcement Firm of the Year&lt;/li&gt;
    &lt;li&gt;Government Investigations Firm of the Year&lt;/li&gt;
    &lt;li&gt;Healthcare Pricing &amp;amp; Reimbursement Firm of the Year&lt;/li&gt;
    &lt;li&gt;Licensing &amp;amp; Collaboration Firm of the Year&lt;/li&gt;
    &lt;li&gt;Life Cycle Firm of the Year&lt;/li&gt;
    &lt;li&gt;Product Liability Firm of the Year&lt;/li&gt;
    &lt;li&gt;Regulatory Firm of the Year&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following Arnold &amp;amp; Porter lawyers have been shortlisted for awards in their respective practices:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Mahnu Davar &amp;mdash; Healthcare Advocacy Attorney of the Year&lt;/li&gt;
    &lt;li&gt;Jeffrey Handwerker &amp;mdash; Regulatory Attorney of the Year: Pricing &amp;amp; Reimbursement&lt;/li&gt;
    &lt;li&gt;Jennifer Oh &amp;mdash; U.S. Rising Star&lt;/li&gt;
    &lt;li&gt;Michael Rogoff &amp;mdash; Government Investigations Attorney of the Year&lt;/li&gt;
    &lt;li&gt;Eva Temkin &amp;mdash; FDA Litigation &amp;amp; Enforcement Attorney of the Year; Woman Practitioner of the Year&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The winners will be announced at the &lt;em&gt;LMG Life Sciences Americas&lt;/em&gt; Awards ceremony in New York City on September 10, 2026.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{2C110C35-EC7A-475E-8254-6EC1E28F279C}</guid><link>https://clsbluesky.law.columbia.edu/2026/07/20/arnold-porter-discusses-proposed-fdic-overhaul-of-confidential-information-regulations/</link><a10:author><a10:name>Robert C. Azarow</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/azarow-robert-c</a10:uri><a10:email>robert.azarow@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>David F. Freeman, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/freeman-david-f</a10:uri><a10:email>David.Freeman@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Amber A. Hay</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hay-amber-a</a10:uri><a10:email>amber.hay@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kevin M. Toomey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/toomey-kevin-m</a10:uri><a10:email>kevin.toomey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><title>Arnold Porter &amp; Discusses Proposed FDIC Overhaul of Confidential Information Regulations</title><pubDate>Mon, 20 Jul 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{0480B2F7-4D3D-4610-98DF-1B631328D139}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/maria-chedid-comments-in-law360-on-ai-trends-in-arbitration</link><title>Maria Chedid Comments in Law360 on AI Trends in Arbitration </title><description>Maria Chedid, global chair of Arnold &amp;amp; Porter&amp;rsquo;s International Arbitration practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "3 Int'l Arbitration Trends To Watch: Midyear Report," examining key developments expected to shape arbitration through the remainder of 2026.</description><pubDate>Thu, 16 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Maria Chedid, global chair of Arnold &amp;amp; Porter&amp;rsquo;s International Arbitration practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "3 Int'l Arbitration Trends To Watch: Midyear Report," examining key developments expected to shape arbitration through the remainder of 2026.&lt;/p&gt;
&lt;p&gt;Drawing on her extensive research into challenges to arbitral awards across all U.S. federal courts, Maria noted a material increase in claims alleging arbitrator misconduct over the past five years.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Looking ahead, Maria explained that as arbitrators increasingly adopt artificial intelligence, parties are likely to raise new challenges to awards based on its use. "There's a lot of conversation in the arbitration community about how we can better use AI to improve efficiency of arbitration," she said. "As arbitrators now are increasingly using AI to facilitate their side of the dispute resolution process, I expect it will give rise to a variety of different challenges against them once the awards are issued."&lt;/p&gt;
&lt;p&gt;Maria also pointed to a recent Canadian court decision vacating an arbitral award after an arbitrator relied on AI-generated, fabricated legal citations. While calling it "an extreme case," she said it "does provide a preview of how parties might...attempt to argue that they were deprived of a fair opportunity to present their case due to an arbitrator's delegation to AI," underscoring the evolving legal questions surrounding AI's role in arbitration.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2501130/3-int-l-arbitration-trends-to-watch-midyear-report"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{757070C8-6C05-4D67-9151-C18620BC6E21}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/law360-quotes-john-elwood-on-the-us-supreme-courts-2025-2026-term</link><title>Law360 Quotes John Elwood on the U.S. Supreme Court's 2025–2026 Term</title><description>&lt;span&gt;John Elwood, head of Arnold &amp;amp; Porter&amp;rsquo;s Appellate &amp;amp; Supreme Court practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "Circuit-By-Circuit Guide To The US Supreme Court's Term," analyzing how the federal courts of appeals fared during the U.S. Supreme Court's recently concluded term.&lt;/span&gt;&lt;br /&gt;</description><pubDate>Thu, 16 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;John Elwood, head of Arnold &amp;amp; Porter&amp;rsquo;s Appellate &amp;amp; Supreme Court practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "Circuit-By-Circuit Guide To The US Supreme Court's Term," analyzing how the federal courts of appeals fared during the U.S. Supreme Court's recently concluded term.&lt;/p&gt;
&lt;p&gt;Commenting on the Court's review of decisions from the U.S. Court of Appeals for the D.C. Circuit, John observed that the appellate court appropriately applied then-existing Supreme Court precedent in Trump v. Slaughter, which involved the President's authority to remove Federal Trade Commission commissioners. "Humphrey's Executor involved that very agency, the FTC, so they did what they were supposed to do, and the Supreme Court changed the law," he said. "So [you] can't fault them for that reversal."&lt;/p&gt;
&lt;p&gt;John also discussed the Supreme Court's decision involving the Federal Communications Commission's penalty authority, explaining that although the Court reversed the Fifth Circuit, the outcome reflected significant concessions made by the U.S. solicitor general during the litigation. "The way that the solicitor general was able to eke out a win in the Supreme Court was by basically saying that the FCC's action didn't mean anything," John said.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2498688/circuit-by-circuit-guide-to-the-us-supreme-court-s-term"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{87F2844B-49FB-47AB-AEC7-70ABB1CD0833}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/latinvex-again-ranks-arnold-porter-among-top-international-law-firms-in-latin-america</link><title>Latinvex Again Ranks Arnold &amp; Porter Among Top International Law Firms in Latin America</title><description>Arnold &amp;amp; Porter has again been recognized in&lt;em&gt; Latinvex&amp;rsquo;s&lt;/em&gt; &amp;ldquo;Latin America: Top International Law Firms&amp;rdquo; list in four categories.</description><pubDate>Thu, 16 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has again been recognized in &lt;em&gt;Latinvex&lt;/em&gt;&amp;rsquo;s &amp;ldquo;Latin America: Top International Law Firms&amp;rdquo; list in four categories. The 2026 list, based on &amp;ldquo;a combination of factors, including value, prominence, and scope of work and references among clients and peers,&amp;rdquo; reflects the firm&amp;rsquo;s sustained achievement in the region.&lt;/p&gt;
&lt;p&gt;The firm received rankings in the following categories:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Arbitration&lt;/li&gt;
    &lt;li&gt;Capital Markets&lt;/li&gt;
    &lt;li&gt;FCPA &amp;amp; Fraud&lt;/li&gt;
    &lt;li&gt;Mining&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Arnold &amp;amp; Porter has advised clients across Latin America for more than 40 years, combining deep regional knowledge with market-leading capabilities in cross-border disputes, complex corporate and finance transactions, and high-stakes regulatory matters. The firm&amp;rsquo;s multidisciplinary team includes many native and fluent Spanish and Portuguese speakers, as well as lawyers trained in both Latin American civil law and U.S. common law, enabling it to provide practical, strategic counsel that reflects the region&amp;rsquo;s legal, business, and cultural landscape.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{519C6EA3-2CD2-488C-A1B5-6A4264F345ED}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/ftc-and-doj-settlement-for-hsr-act-violations</link><a10:author><a10:name>Matthew Tabas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabas-matthew</a10:uri><a10:email>matthew.tabas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter G. Danias</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/danias-peter</a10:uri><a10:email>peter.danias@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ryan Z. Watts</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/watts-ryan-z</a10:uri><a10:email>ryan.watts@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Summer Perez</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/perez-summer</a10:uri><a10:email>summer.perez@arnoldporter.com</a10:email></a10:author><title>FTC and DOJ Secure $12 Million Settlement for HSR Act Violations in Edwards/JC Medical Deal</title><description>On July 13, 2026, the U.S. Department of Justice (DOJ), on behalf of the Federal Trade Commission (FTC), announced a proposed settlement with Edwards Lifesciences and Genesis MedTech over allegations that the companies deliberately structured Edwards' acquisition of JC Medical to evade the Hart-Scott-Rodino (HSR) Act's premerger notification requirements. The settlement imposes a record $12 million in combined civil penalties and underscores the agencies' willingness to scrutinize transactions involving pre-commercial medical technologies, particularly where related deal components may have been divided to avoid HSR filing thresholds. The case, coupled with the FTC's successful challenge to Edwards' proposed acquisition of JenaValve, reinforces that antitrust regulators will look beyond a transaction's formal structure to its economic substance and highlights the importance of involving antitrust counsel early when structuring complex acquisitions.</description><pubDate>Thu, 16 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On July 13, 2026, the U.S. Department of Justice (DOJ), acting on behalf of the Federal Trade Commission (FTC), filed a complaint and proposed final judgment in the United States District Court for the District of Columbia against Edwards Lifesciences Corporation (Edwards) and Genesis MedTech Group Limited (Genesis), alleging that the parties structured Edwards&amp;rsquo; acquisition of JC Medical, Inc. (JC Medical) to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). Under the terms of the proposed settlement, Edwards will pay a $10 million civil penalty and Genesis will pay a $2 million civil penalty &amp;mdash; which together constitute the largest civil penalty the agencies have obtained for a failure to file under the HSR Act. The settlement follows the FTC&amp;rsquo;s successful challenge, discussed in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/02/ftc-antitrust-enforcement-development-pipeline-deals" target="_self"&gt;February 2026 Advisory&lt;/a&gt;, to Edwards&amp;rsquo; proposed acquisition of JenaValve Technology, Inc. (JenaValve), which the district court enjoined in January 2026. &lt;/p&gt;
&lt;p&gt;Together, the two matters illustrate the agencies&amp;rsquo; continued focus on acquisitions of pre-commercial pipeline medical technology and strict enforcement of the HSR Act&amp;rsquo;s reporting requirements. Notably, this settlement is also one of the rare instances in which the agencies have imposed civil penalties on both the buyer and the seller, reflecting their conclusion that both Edwards and Genesis were culpable in structuring the deal to avoid HSR review. The FTC contended that Genesis&amp;rsquo; own failure to file constituted a violation of the HSR Act.[[N:Compl. &amp;para; 41, &lt;em&gt;United States v. Edwards Lifesciences Corp.&lt;/em&gt;, No. 1:26-cv-02450, Dkt. 1 (D.D.C. July 13, 2026) (&amp;ldquo;Section 7A(g)(1) of the Clayton Act, 15 U.S.C. &amp;sect; 18a(g)(1), provides that any person, or any officer, director, or partner thereof, who fails to comply with any provision of the HSR Act is liable to the United States for a civil penalty for each day during which such person is in violation.&amp;rdquo;).]]&lt;/p&gt;
&lt;h2&gt;Background of the Transaction&lt;/h2&gt;
&lt;p&gt;According to the complaint, on July 22, 2024, Edwards, a global cardiac device manufacturer, agreed to acquire JC Medical from Genesis for $115 million, plus milestone payments with an ostensible value of approximately $1.8 million.[[N:Id. &amp;para; 1.]] JC Medical was, at the time, engaged in U.S. clinical trials for a transcatheter aortic valve replacement device to treat aortic regurgitation (a TAVR-AR device). Edwards closed the JC Medical acquisition the same day it was signed, without submitting a filing under the HSR Act and without observing the Act&amp;rsquo;s statutory waiting period.[[N:Id. &amp;para;&amp;para; 1, 23.]] The parties did not publicly announce the transaction at that time.&lt;/p&gt;
&lt;p&gt;Contemporaneously with the JC Medical acquisition, Edwards agreed to invest $25 million in non-voting securities of Genesis itself.[[N:Id. &amp;para;&amp;para; 5, 24.]] The complaint alleges that Edwards and Genesis viewed the JC Medical purchase price and the Genesis investment as part of a single, integrated deal &amp;mdash; negotiated together and documented in term sheets transmitted in a single email &amp;mdash; but treated them as legally separate transactions for HSR purposes so that neither, viewed in isolation, would meet the HSR Act&amp;rsquo;s then-applicable $119.5 million reporting threshold.[[N:Id. &amp;para;&amp;para; 3-5, 27-31.]] Had the two payments been aggregated, the complaint alleges, the transaction value would have exceeded the &amp;ldquo;size of transaction&amp;rdquo; threshold and triggered a mandatory HSR filing and waiting period.[[N:Id. &amp;para;&amp;para; 5, 34-35.]]&lt;/p&gt;
&lt;p&gt;The very next day, July 23, 2024, Edwards agreed to acquire JenaValve &amp;mdash; JC Medical&amp;rsquo;s only competitor in the development of TAVR-AR devices &amp;mdash; for $945 million.[[N:Id. &amp;para; 1; see also Mem. Op. at 21, &lt;em&gt;FTC v. Edwards Lifesciences Corp.&lt;/em&gt;, No. 1:25-cv-02569-RC, Dkt. 178 (D.D.C. Jan. 9, 2026).]] The complaint alleges that, in acquiring both companies, Edwards sought to own &amp;ldquo;the only two companies in the United States with TAVR-AR devices in clinical trials.&amp;rdquo;[[N:Compl. &amp;para; 1 (quoting Mem. Op. at 1).]] Notably, JenaValve was not aware, at the time it agreed to be acquired, that Edwards had already acquired JC Medical.[[N:Mem. Op. at 22.]] &lt;/p&gt;
&lt;p&gt;As discussed in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/02/ftc-antitrust-enforcement-development-pipeline-deals" target="_self"&gt;February 2026 Advisory&lt;/a&gt;, the FTC separately challenged Edwards&amp;rsquo; proposed acquisition of JenaValve under Section 7 of the Clayton Act, and on January 9, 2026, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted the FTC&amp;rsquo;s request for a preliminary injunction blocking that deal.[[N:Id. at 107.]] The parties abandoned the transaction shortly thereafter.&lt;/p&gt;
&lt;h2&gt;HSR Filing Requirements and the Prohibition on Structuring to Avoid Review&lt;/h2&gt;
&lt;p&gt;The HSR Act requires parties to an acquisition of voting securities or assets that exceeds certain dollar thresholds &amp;mdash; $119.5 million at the time of the JC Medical transaction &amp;mdash; to file premerger notification with the FTC and DOJ and to observe a statutory waiting period before closing.[[N:15 U.S.C. &amp;sect; 18a(a); Compl. &amp;para; 15.]] The purpose of the notification and waiting period is to give the antitrust agencies an opportunity to review a transaction, and, where warranted, to seek an injunction, before the parties consummate an anticompetitive acquisition.&lt;/p&gt;
&lt;p&gt;The HSR Rules contain an explicit anti-avoidance provision, 16 C.F.R. &amp;sect; 801.90, which provides that any transaction or device entered into for the purpose of avoiding the Act&amp;rsquo;s filing obligations &amp;ldquo;shall be disregarded,&amp;rdquo; and that reportability is instead determined by applying the HSR Act to the substance of the transaction.[[N:16 C.F.R. &amp;sect; 801.90.]] Relatedly, where the acquisition price for voting securities has been determined, that price generally sets the transaction value for HSR purposes, and the value must reflect the full consideration paid for the securities, regardless of the form in which that consideration is delivered.[[N:16 C.F.R. &amp;sect; 801.10(a)(2), (c)(2)-(3).]]&lt;/p&gt;
&lt;p&gt;Applying these principles, the complaint alleges that the $25 million Genesis investment was, in substance, additional consideration for JC Medical rather than an independent transaction, and that Edwards&amp;rsquo; own communications acknowledged the JC Medical deal was structured to stay &amp;ldquo;below the threshold&amp;rdquo; intentionally.[[N:Compl. &amp;para;&amp;para; 27, 32-35.]] Because the aggregated consideration exceeded $119.5 million, the government alleges the transaction was reportable under the HSR Act notwithstanding its bifurcated form.&lt;/p&gt;
&lt;h2&gt;Key Terms of the Settlement&lt;/h2&gt;
&lt;p&gt;The Commission voted 2-0 to accept the proposed settlement and refer the matter to DOJ, which filed the complaint and proposed final judgment on the FTC&amp;rsquo;s behalf on July 13, 2026. Key terms of the proposed final judgment,[[N:Proposed Final Judgment, &lt;em&gt;United States v. Edwards Lifesciences Corp.&lt;/em&gt;, No. 1:26-cv-02450, Dkt. 1-3 (D.D.C. July 13, 2026).]] which is subject to review by the court, include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;em&gt;Civil penalties&lt;/em&gt;. Edwards will pay a $10 million civil penalty and Genesis will pay a $2 million civil penalty &amp;mdash; together described by the FTC as the largest combined penalty ever obtained for an HSR filing failure.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Prior notification requirement&lt;/em&gt;. For five years, Edwards must provide 30 days&amp;rsquo; advance written notification to the FTC &amp;mdash; on the standard HSR Notification and Report Form, but without a filing fee and without notice to DOJ &amp;mdash; before acquiring any ownership interest in a firm that (i) commercially sells a TAVR-AR device in the United States, (ii) is engaged in U.S. clinical trials for a TAVR-AR device, or (iii) holds an FDA Investigational Device Exemption to conduct such trials. If the FTC requests additional information during the 30-day period, Edwards must wait a further 30 days after responding before closing.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Antitrust compliance program&lt;/em&gt;. Edwards must designate an antitrust compliance officer, distribute the final judgment, and provide training to relevant officers, directors, and employees with responsibility over business development, strategic planning, or M&amp;amp;A, and obtain periodic written certifications of compliance.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Compliance inspection and enforcement&lt;/em&gt;. The judgment gives DOJ and the FTC ongoing rights to inspect records and interview personnel, and preserves the government&amp;rsquo;s right to seek contempt remedies, an extension of the judgment, and recovery of its enforcement costs for violations occurring even after the judgment&amp;rsquo;s term.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;No admission of liability&lt;/em&gt;. Entry of the final judgment does not constitute an admission or finding of wrongdoing, and Edwards and Genesis deny any violation of law.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Practical Takeaways&lt;/h2&gt;
&lt;p&gt;The Edwards/JC Medical settlement, read together with the JenaValve injunction, offers several lessons for parties structuring acquisitions &amp;mdash; particularly in life sciences and other innovation-intensive industries where competitively significant assets may still be in development:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;em&gt;Substance governs over form&lt;/em&gt;. Parties cannot avoid the HSR Act&amp;rsquo;s notification and waiting period requirements by dividing a single economic transaction into formally separate pieces &amp;mdash; here, an acquisition price and a contemporaneous investment &amp;mdash; each priced to fall below the reporting threshold. Where related transactions are negotiated together, documented together, and intended to compensate for the same asset, there is a risk that the agencies will assert they should be aggregated.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Engage antitrust counsel early to evaluate aggregation risk&lt;/em&gt;. Whenever a transaction includes minority investments, licensing arrangements, earnouts, or other consideration flowing between the same or related parties at or near the same time as a primary acquisition, clients should consult antitrust counsel before signing to assess whether those arrangements should be aggregated with the primary transaction for HSR valuation purposes &amp;mdash; and, if so, whether the combined transaction is reportable. This analysis is fact-intensive and turns on the parties&amp;rsquo; contemporaneous documents and communications, which the agencies will scrutinize closely after the fact.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Structuring to avoid review compounds risk rather than reduces it&lt;/em&gt;. Avoiding HSR review for the JC Medical deal did not prevent scrutiny as the agencies are free to investigate and seek enforcement against deals that are not reportable. Here, FTC used the failure to file the JC Medical transaction against Edwards in the preliminary injunction proceeding, claiming it was an implied admission that the simultaneous JenaValve acquisition would raise antitrust risk.[[N:Pl.&amp;rsquo;s Proposed Findings of Fact and Conclusions of Law, &lt;em&gt;FTC v. Edwards Lifesciences Corp.&lt;/em&gt;, No. 1:25-cv-02569-RC, Dkt. 169 at 99-100 (D.D.C. Dec. 16, 2025).]]&lt;/li&gt;
&lt;/ul&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{94778AB0-AEC9-47BF-AA1C-77B135A77779}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/07/global-anti-corruption-insights-summer-2026</link><a10:author><a10:name>Marcus A. Asner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/asner-marcus-a</a10:uri><a10:email>marcus.asner@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Soo-Mi Rhee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rhee-soomi</a10:uri><a10:email>soo-mi.rhee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel Bernstein</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bernstein-daniel</a10:uri><a10:email>daniel.bernstein@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Caroline Lee Dorsey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dorsey-caroline</a10:uri><a10:email>caroline.dorsey@arnoldporter.com</a10:email></a10:author><title>Global Anti-Corruption Insights: Summer 2026</title><description>In this Newsletter, we highlight significant policy and case developments concerning the U.S. Foreign Corrupt Practices Act and other federal laws used in bribery cases, along with a few anti-corruption updates from around the world.</description><pubDate>Thu, 16 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The U.S. Department of Justice (DOJ) has continued to enforce the Foreign Corrupt Practices Act (FCPA) in 2026, while also seeking to dismiss certain high-profile FCPA prosecutions that began before the second Trump administration.&lt;/p&gt;
&lt;p&gt;Civil enforcement has remained comparatively quiet, with no new FCPA enforcement actions by the U.S. Securities and Exchange Commission (SEC) so far this year. Although the SEC has not made any official policy pronouncements regarding the FCPA, top enforcement officials there have discussed new approaches to the enforcement of securities laws more generally.&lt;/p&gt;
&lt;p&gt;Across the pond, the UK Serious Fraud Office (SFO) entered into its first deferred prosecution agreement in several years, and the EU adopted a new Anti-Corruption Directive.&lt;/p&gt;
&lt;p&gt;Meanwhile, Chinese authorities have updated a regulatory framework for criminal bribery and issued new guidance on the enforcement of a commercial bribery law, while continuing to focus on anti-corruption investigations and prosecutions.&lt;/p&gt;
&lt;p&gt;We cover these stories and more below.&lt;/p&gt;
&lt;h2&gt;DOJ Resolves FCPA Case in Medical Device Industry Under New Corporate Enforcement Policy&lt;/h2&gt;
&lt;p&gt;In March, DOJ issued a formal &lt;a rel="noopener noreferrer" href="https://www.justice.gov/criminal/media/1431846/dl?inline" target="_blank"&gt;declination letter&lt;/a&gt; to French medical device company Balt SAS and its U.S. subsidiary pursuant to the department&amp;rsquo;s revised Corporate Enforcement and Voluntary Self-Disclosure Policy. According to DOJ, Balt paid bribes to a physician who served in a senior role at a state-owned French public hospital in order for the physician to cause the hospital to purchase medical devices from Balt. DOJ considered this physician to be a &amp;ldquo;foreign official&amp;rdquo; for purposes of the FCPA. In granting a declination, DOJ credited Balt&amp;rsquo;s timely self-disclosure, full cooperation, appropriate remediation, disgorgement of $1.2 million in ill-gotten gains, and parallel resolution with authorities in France. Two individuals &amp;mdash; David Ferrera, a former Balt executive in the United States, and Marc Tilman, a former consultant to Balt &amp;mdash; have been &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-resolves-foreign-bribery-investigation-balt-sas-healthcare-executive-and" target="_blank"&gt;indicted&lt;/a&gt; on related FCPA and money laundering charges for their roles in the alleged bribery scheme.&lt;/p&gt;
&lt;p&gt;The Balt declination was DOJ&amp;rsquo;s first under the new department-wide &lt;a rel="noopener noreferrer" href="https://www.justice.gov/dag/media/1430731/dl?inline" target="_blank"&gt;corporate enforcement policy&lt;/a&gt; released on March 10, 2026. The policy, which builds on a prior framework used by the DOJ Criminal Fraud Section, sets up three tiers of outcomes:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;em&gt;&lt;strong&gt;Declinations&lt;/strong&gt;&lt;/em&gt; for companies that voluntarily self-disclose to an appropriate DOJ criminal component, fully cooperate, timely and appropriately remediate, and face no aggravating circumstances, such as serious or pervasive misconduct, significant harm, or a recent prior resolution for similar conduct. Companies that earn declinations must still disgorge ill-gotten gains and pay restitution or other compensation to victims.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;&lt;strong&gt;Reduced-penalty resolutions&lt;/strong&gt;&lt;/em&gt; for &amp;ldquo;near miss&amp;rdquo; situations where companies cooperate and timely remediate but otherwise fall short of a full declination, including because of delayed disclosures or the presence of aggravating factors. To encourage even imperfect cooperation, the policy offers benefits such as a non-prosecution agreement (absent particularly egregious or multiple aggravating circumstances) with a term of less than three years, no independent compliance monitor, and a fine reduction of 50% to 75% off the low end of the Sentencing Guidelines range.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;&lt;strong&gt;Discretionary credit&lt;/strong&gt;&lt;/em&gt; for companies that do not voluntarily self-disclose but still cooperate or remediate to some degree. In considering monetary penalties for these companies, DOJ will weigh the effectiveness of the company&amp;rsquo;s compliance program, the quality and timing of cooperation, and the steps taken to fix the underlying problem.[[N:For more commentary on the revised corporate enforcement policy, see Arnold &amp;amp; Porter&amp;rsquo;s March 2026 &lt;em&gt;&lt;a href="/en/perspectives/blogs/enforcement-edge/2026/03/dojs-department-wide-message-to-the-white-collar-bar"&gt;&lt;em&gt;Enforcement Edge&lt;/em&gt; blog post&lt;/a&gt;&lt;/em&gt;.]]&lt;/li&gt;
&lt;/ol&gt;
&lt;h2&gt;DOJ Litigates Rare Corporate Indictment Under FCPA&lt;/h2&gt;
&lt;p&gt;In March 2026, SGO Corporation Limited (SGO) &amp;mdash; the parent of the voting machine and election services company known as Smartmatic &amp;mdash; filed a motion to dismiss FCPA charges on grounds of vindictive and selective prosecution. SGO argues that last year&amp;rsquo;s indictment was based, at least in part, on the company&amp;rsquo;s &amp;ldquo;limited role in the 2020 election and on its proper exercise of its First Amendment rights both to publicly and vehemently defend its integrity and to bring defamation lawsuits against the President&amp;rsquo;s political allies and Fox News.&amp;rdquo; SGO further contends that the government has declined to pursue charges against similarly situated companies and individuals, pointing out that it has been 15 years since a company was last indicted under the FCPA.[[N:Motion to Dismiss for Vindictive and Selective Prosecution, &lt;em&gt;USA v. Donato Bautista et al.&lt;/em&gt;, 1:24-CR-20343-KMW (S.D. Fla. March 10, 2025), ECF No. 351.]] In response, the government counters that the investigation into SGO&amp;rsquo;s role in an alleged $1 million bribery scheme tied to the 2016 Philippine elections began in 2018 under career prosecutors and that the corporate entity was indicted only after pre-trial settlement negotiations broke down.[[N:Government&amp;rsquo;s Response in Opposition to SGO&amp;rsquo;s Motion to Dismiss for Vindictive and Selective Prosecution at 1-2, &lt;em&gt;USA v. Donato Bautista et al.&lt;/em&gt;, 1:24-CR-20343-KMW (S.D. Fla. March 24, 2026), ECF No. 358.]] The case is being closely watched because corporate FCPA indictments are rare, and the litigation may provide insight into DOJ&amp;rsquo;s current charging priorities.&lt;/p&gt;
&lt;h2&gt;Individuals Go to Trial, Plead Guilty in FCPA Prosecutions&lt;/h2&gt;
&lt;p&gt;DOJ has gone to trial and secured guilty pleas in FCPA cases this year.&lt;/p&gt;
&lt;p&gt;In February, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/former-coal-company-executive-convicted-international-bribery-and-money-laundering-scheme" target="_blank"&gt;a federal jury&lt;/a&gt; in Pennsylvania found Charles Hunter Hobson, former vice president of Corsa Coal Corporation, guilty of violating the FCPA and other federal criminal laws. The case was briefly put on hold last year following President Trump&amp;rsquo;s February 2025 &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2025/02/14/2025-02736/pausing-foreign-corrupt-practices-act-enforcement-to-further-american-economic-and-national-security" target="_blank"&gt;executive order&lt;/a&gt; that paused most enforcement of the FCPA in light of stated concerns about harm to &amp;ldquo;American economic competitiveness.&amp;rdquo; But in April 2025, DOJ greenlit the case to proceed. According to DOJ, Hobson used his position to pay bribes to Egyptian government officials, via an Egyptian intermediary, to win future contracts for Corsa to sell coal products to Al Nasr Company for Coke and Chemicals, a state-owned and state-controlled manufacturing company in Egypt. In addition to the almost $140 million in coal supply contracts for Corsa, Hobson received over $200,000 in kickbacks from the Egyptian intermediary. Hobson has not yet been sentenced.&lt;/p&gt;
&lt;p&gt;In April, U.S. District Judge Kenneth M. Hoyt granted a post-trial motion to acquit Ram&amp;oacute;n Alexandro Rovirosa Mart&amp;iacute;nez of all charges, after a jury had found the defendant guilty of FCPA violations related to a bribery scheme involving the Mexican state-owned oil company PEMEX. Judge Hoyt cited a lack of evidence to support the conviction in violation of the defendant&amp;rsquo;s Sixth Amendment Confrontation Clause rights. The judge agreed with the defendant that the government improperly introduced WhatsApp messages translated from Spanish, without calling the translators to the witness stand during trial.[[N:Memorandum and Order Dismissing Indictment and Granting an Acquittal, &lt;em&gt;USA v. Martinez, et al.&lt;/em&gt;, 4:25-CR-00415 (S.D. Tex. April 14, 2026), ECF No. 147.]] On May 8, 2026, DOJ appealed to the U.S. Court of Appeals for the Fifth Circuit.[[N:Notice of Appeal, &lt;em&gt;USA v. Martinez, et al.&lt;/em&gt;, 4:25-CR-00415 (S.D. Tex. May 8, 2026), ECF No. 152.]] The appeal may clarify when translated messages can be introduced at trial and whether translators must be available for cross-examination.&lt;/p&gt;
&lt;p&gt;In May, Alfonso Wilson, a resident of Texas and CEO of Oil Technologies Consortium, pleaded guilty to conspiracy to violate the FCPA in connection with a corruption scheme involving a $540 million contract to supply PEMEX with drilling equipment.[[N: See Information, &lt;em&gt;USA v. Wilson&lt;/em&gt;, Docket No. 4:26-cr-00135 (S.D. Tex. Mar. 16, 2026), ECF No. 1; Unopposed Motion for Money Judgment, ECF No. 26.]]&lt;/p&gt;
&lt;p&gt;Also in May, just 11 days before his trial was set to begin, Abraham Cigarroa Cervantes &amp;mdash; a Mexican citizen and the former finance director of Stericycle&amp;rsquo;s Latin America division &amp;mdash; pleaded guilty to conspiracy to violate the FCPA. According to his proffer statement, Cigarroa authorized the distribution of funds to Mexican vendors that ostensibly provided services for Stericycle; in reality, these vendors would create fake invoices and use the funds to bribe officials at Mexican state-owned entities in exchange for business opportunities and other advantages for Stericycle.[[N: Factual Proffer Statement, &lt;em&gt;USA v. Cervantes&lt;/em&gt;, Docket No. 1:24-cr-20109 (S.D. Fla. Mar. 19, 2024), ECF No. 26; see also DOJ, Press Release, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/archives/opa/pr/former-finance-director-charged-role-10m-foreign-bribery-scheme" target="_blank"&gt;Former Finance Director Charged for Role in $10M Foreign Bribery Scheme&lt;/a&gt; (Mar. 19, 2024).]] Stericycle &lt;a rel="noopener noreferrer" href="https://www.justice.gov/archives/opa/pr/stericycle-agrees-pay-over-84-million-coordinated-foreign-bribery-resolution" target="_blank"&gt;resolved corporate FCPA charges&lt;/a&gt; with the government back in 2022.&lt;/p&gt;
&lt;p&gt;In May, the DOJ filed a motion to voluntarily dismiss FCPA and other criminal charges it initially brought in 2024 against prominent Indian businessmen associated with the Adani Group for their alleged roles in a bribery and securities fraud scheme. &lt;a rel="noopener noreferrer" href="https://www.justice.gov/usao-edny/pr/billionaire-chairman-conglomerate-and-seven-other-senior-business-executives-indicted" target="_blank"&gt;The alleged scheme involved&lt;/a&gt; $250 million in bribes to Indian government officials to secure solar energy contracts, as well as efforts to conceal bribery from U.S. investors. When asked to explain its decision to drop the charges, DOJ told a U.S. District Court Judge for the Eastern District of New York that, in addition to the challenges of prosecuting foreign individuals for foreign conduct: &amp;ldquo;[T]he alleged conduct did not involve criminal organizations, did not have any effect on U.S. companies, did not in any way implicate national security, was not egregious, and has been the subject of investigations in India&amp;hellip;. The FCPA charges here therefore do not plausibly satisfy any of the bases given in the Blanche Memorandum for FCPA charges worthy of proceeding.&amp;rdquo;[[N:Notice re Response to Court&amp;rsquo;s June 26 Order, &lt;em&gt;USA v. Adani et al.&lt;/em&gt;, Docket No. 1:24-cr-00433 (E.D.N.Y. Oct. 24, 2024), ECF No. 37.]] (The &amp;ldquo;Blanche Memorandum&amp;rdquo; set forth &lt;a rel="noopener noreferrer" href="https://www.justice.gov/dag/media/1403031/dl" target="_blank"&gt;guidelines for the investigation and enforcement of the FCPA&lt;/a&gt; following Executive Orders by President Trump last year.)&lt;/p&gt;
&lt;p&gt;Certain defendants who also faced civil charges have entered into a related settlement with the SEC.[[N: Consent Motion to Approve Consent Judgment, &lt;em&gt;SEC v. Gautam Adani and Sagar Adani&lt;/em&gt;, No. 1:24-cv-08080 (E.D.N.Y. Nov. 20, 2024), ECF No. 34.]] Around the same time, an Adani Group company entered into a &lt;a rel="noopener noreferrer" href="https://ofac.treasury.gov/media/935636/download?inline" target="_blank"&gt;civil settlement&lt;/a&gt; with the U.S. Department of the Treasury&amp;rsquo;s Office of Foreign Assets Control to resolve an investigation into potential sanctions violations.&lt;/p&gt;
&lt;h2&gt;DOJ Pursues Non-FCPA Foreign Corruption Cases&lt;/h2&gt;
&lt;p&gt;In 2026, DOJ also used federal laws beyond the FCPA to target international corruption. For example, DOJ secured a guilty plea under the Travel Act from Peter Weinzierl, an Austrian citizen and former CEO of the Austrian lender Meinl Bank AG, related to his alleged role in helping Odebrecht SA hide $170 million used to bribe government officials and defraud the Brazilian government.[[N:Minute Entry Order, &lt;em&gt;USA v. Weinzierl, et al&lt;/em&gt;, Docket No. 1:20-cr-00383 (E.D.N.Y. June 11, 2026), ECF No. 28.]]&lt;/p&gt;
&lt;p&gt;DOJ also has pursued corruption cases involving U.S. military contracts. &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/former-nato-official-and-turkish-defense-contractor-indicted-bribery-scheme-related-military" target="_blank"&gt;An indictment unsealed in January&lt;/a&gt; charged Bahadir Hatipoglu, who resides in Lithuania and is the owner of companies that received contracts from the North Atlantic Treaty Organization (NATO) and the U.S. military, and Ralf Grywnow, who resides in Poland and is a former NATO procurement official, with one count of conspiracy to commit wire fraud and four counts of wire fraud. According to the indictment, Hatipoglu bribed Grywnow with cash, a romantic encounter, and assistance with the construction and furnishing of a house, in exchange for help securing contracts with the U.S. military. DOJ is seeking to extradite the individuals to the United States.&lt;/p&gt;
&lt;p&gt;Moreover, in April, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-seeks-forfeit-beverly-hills-mansion-purchased-proceeds-scheme-defraud-us" target="_blank"&gt;DOJ filed a civil forfeiture complaint in the U.S. District Court for Central California&lt;/a&gt;, seeking the forfeiture of a Beverly Hills mansion that was allegedly purchased and renovated with proceeds from a scheme, perpetrated by a Virginia defense contractor, to defraud the U.S. Department of Defense&amp;rsquo;s Defense Logistics Agency, bribe Iraqi officials, and violate U.S. money laundering laws.&lt;/p&gt;
&lt;h2&gt;SEC Signals Enforcement Shift&lt;/h2&gt;
&lt;p&gt;While the SEC has not brought any new FCPA cases or announced any new FCPA enforcement policies in 2026, SEC officials have spoken about their current approach to enforcement of securities laws (which include the FCPA). In April 2026, when releasing enforcement results for the 2025 fiscal year, &lt;a rel="noopener noreferrer" href="https://www.sec.gov/newsroom/press-releases/2026-34" target="_blank"&gt;SEC Chairman Paul S. Atkins stated&lt;/a&gt; that the Commission has &amp;ldquo;recentered its enforcement program &amp;hellip; by prioritizing cases that provide meaningful investor protection and strengthen market integrity.&amp;rdquo; The same press release criticized the prior administration&amp;rsquo;s &amp;ldquo;aggressive pursuit of novel legal theories&amp;rdquo; and cases &amp;ldquo;not sufficiently grounded in the federal securities laws.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In May 2026, the SEC &lt;a rel="noopener noreferrer" href="https://www.sec.gov/newsroom/press-releases/2026-45-sec-rescinds-policy-regarding-denials-settlements-enforcement-actions" target="_blank"&gt;rescinded&lt;/a&gt; its 54-year-old policy that prohibited settling defendants from publicly denying the agency&amp;rsquo;s allegations. The SEC will no longer require parties to agree to &amp;ldquo;no-deny&amp;rdquo; provisions as a condition of settling civil enforcement actions. According to the SEC, the policy had a minimal &amp;ldquo;effect on the public interest&amp;rdquo; and &amp;ldquo;created an incorrect impression that the Commission is trying to shield itself from criticism.&amp;rdquo; Since 1972, this policy has allowed companies and individuals to accept &amp;ldquo;neither admit nor deny&amp;rdquo; resolutions.&lt;/p&gt;
&lt;p&gt;Moreover, as Arnold &amp;amp; Porter &lt;a href="/en/perspectives/advisories/2026/03/what-you-need-to-know-about-the-secs-enforcement-manual-update"&gt;previously reported&lt;/a&gt;, February saw the first &lt;a rel="noopener noreferrer" href="https://www.sec.gov/newsroom/press-releases/2026-20-secs-division-enforcement-announces-updates-enforcement-manual" target="_blank"&gt;major update&lt;/a&gt; to the SEC Enforcement Manual since 2017. The revisions incorporate and reflect the structural change to the formal order process resulting from the Commission&amp;rsquo;s March 2025 revocation of authority delegated to Enforcement Division staff. Now, when seeking a formal order, staff must &amp;ldquo;succinctly describe the relevant conduct and potential violations, obtain approval from the Office of the Director, and then submit both the memorandum and the proposed formal order to the full Commission for a vote.&amp;rdquo; The new manual also includes a more predictable and structured Wells process, concrete guidance on how cooperation credit is evaluated for companies, and the restoration of the practice of simultaneously considering settlement offers and statutory disqualification waiver requests.&lt;/p&gt;
&lt;h2&gt;Senator Introduces Bill to Extend FCPA&amp;rsquo;s Statute of Limitations&lt;/h2&gt;
&lt;p&gt;On March 9, 2026, U.S. Senator Elizabeth Warren &lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/senate-bill/4029" target="_blank"&gt;introduced a bill &lt;/a&gt;to extend the FCPA&amp;rsquo;s statute of limitations period to 10 years. The current draft of the bill states it would expire eight years after the date of enactment, which would give future presidential administrations an opportunity to prosecute recent violations of the FCPA. The bill was referred to the Senate Judiciary Committee. &lt;/p&gt;
&lt;h2&gt;International News&lt;/h2&gt;
&lt;p&gt;In May 2026, the SFO entered into a &lt;a rel="noopener noreferrer" href="https://www.gov.uk/guidance/sfo-dpa-with-ultra-electronics-holdings-limited-formerly-plc" target="_blank"&gt;Deferred Prosecution Agreement&lt;/a&gt; with Ultra Electronics Holdings Ltd., which agreed to pay approximately &amp;pound;15 million and accept responsibility for the failure to prevent bribery in relation to public-sector contracts in Algeria and Oman. The SFO&amp;rsquo;s investigation reportedly lasted approximately eight years. This was the SFO&amp;rsquo;s 13th DPA and its first since 2022.&lt;/p&gt;
&lt;p&gt;In April 2026, the European Council &lt;a rel="noopener noreferrer" href="https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamental-rights/democracy-eu-citizenship-anti-corruption/anti-corruption/eu-legislation-anti-corruption_en" target="_blank"&gt;adopted a new Anti-Corruption Directive&lt;/a&gt; in an effort to harmonize definitions of corruption and penalties across EU member states. This directive covers both public-sector and private-sector (i.e., commercial) bribery. EU member states now have two years to ensure their national laws conform to the new directive. &lt;/p&gt;
&lt;p&gt;In April 2026, China&amp;rsquo;s Supreme People&amp;rsquo;s Court (SPC) and Supreme People&amp;rsquo;s Procuratorate (SPP) jointly issued their &lt;a rel="noopener noreferrer" href="https://www.court.gov.cn/fabu/xiangqing/497181.html" target="_blank"&gt;Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery (II)&lt;/a&gt;.[[N:For further analysis of Interpretation (II) (&lt;span&gt;关于&lt;/span&gt;&lt;span&gt;办理贪污贿赂刑事案件适用法律若干问题的解释&lt;/span&gt;), see &lt;a href="/en/perspectives/advisories/2026/04/china-compliance-update-anti-corruption-spring-2026"&gt;China Compliance Update: Anti-Corruption &amp;mdash; Spring 2026&lt;/a&gt;.]] Interpretation II took effect on May 1, 2026, and is the first major update to the interpretation of the criminal law of bribery released by the SPC and SPP in a decade. It focuses on private-sector crimes and &amp;ldquo;entity crimes,&amp;rdquo; meaning crimes that carry liability for companies, public institutions, government agencies, and other organizations. Notably, Interpretation (II) lowers the monetary thresholds for bribery and corruption crimes in the private sector and revises the standards for entity crimes and key industries. &lt;/p&gt;
&lt;p&gt;In March 2026, China&amp;rsquo;s State Administration for Market Regulation (SAMR), a main anti-corruption enforcement agency, issued a Notice on Further Implementing the Anti-Unfair Competition Law of the People&amp;rsquo;s Republic of China (AUCL).[[N:&lt;span&gt;市&lt;/span&gt;&lt;span&gt;场监管总局关于进一步贯彻实施《中华人民共和国反不正当竞争法》的通知&lt;/span&gt;]] The notice directed lower-level SAMRs to focus equally on investigation and punishment of paying bribes and accepting bribes when enforcing the AUCL, one of China&amp;rsquo;s primary laws against corruption. &lt;/p&gt;
&lt;p&gt;Enforcement statistics released by Chinese regulators show that anti-corruption remains a high priority, with the volume of anti-corruption investigations and prosecutions continuing to rise year on year.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&lt;em&gt;Julian Karam contributed to this Newsletter. Julian is a summer associate in Arnold &amp;amp; Porter&amp;rsquo;s San Francisco office.&lt;br /&gt;
&lt;/em&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9FBE0E73-3213-4F57-958C-571A37640186}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/corp-fin-issues-new-cfis</link><a10:author><a10:name>Sara Adler</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/adler-sara</a10:uri><a10:email>sara.adler@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Joel I. Greenberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/greenberg-joel-i</a10:uri><a10:email>joel.greenberg@arnoldporter.com</a10:email></a10:author><title>Corp Fin Issues New CFIs</title><description>The U.S. Securities and Exchange Commission Staff has issued updated Compliance and Disclosure Interpretations clarifying several key aspects of the federal securities laws, including that cash-settled total return equity swaps generally do not create beneficial ownership under Section 13 absent an evasive scheme, while emphasizing that arrangements designed to conceal beneficial ownership may still trigger reporting obligations. The guidance also expands disclosure requirements for activist investment vehicles and proxy campaigns, clarifies ongoing reporting obligations for Regulation Crowdfunding issuers, and confirms that certain tender offer notice requirements may be satisfied through a widely disseminated press release with a hyperlink to offer materials, rather than a newspaper advertisement.</description><pubDate>Wed, 15 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On July 9, 2026, the SEC&amp;rsquo;s Division of Corporation Finance issued a number of interpretations covering a variety of topics:&lt;/p&gt;
&lt;h3&gt;Total Return Equity Swaps&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/exchange-act-sections-13d-13g-regulation-13d-g-beneficial-ownership-reporting#105.08" target="_blank"&gt;Question 105.08&lt;/a&gt;: The Staff confirmed the commonly held view that a total return equity swap that: (i) settles exclusively in cash; (ii) only refers to a specified class of equity securities as a reference security; and (iii) does not confer voting or investment power with respect to, or any right to acquire, the reference security (TRS), does not constitute Section 13 beneficial ownership of the reference securities, including any equity securities the counterparty may acquire or hold for hedging purposes. Entry into a TRS does not, by itself, evidence a plan or scheme to evade Section 13 beneficial ownership obligations (as discussed below).&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/exchange-act-sections-13d-13g-regulation-13d-g-beneficial-ownership-reporting#105.09" target="_blank"&gt;Question 105.09&lt;/a&gt;: A person may be deemed to be a Section 13 beneficial owner of equity securities if the person uses an arrangement with the purpose or effect of preventing the vesting of beneficial ownership as part of a plan or scheme to evade the reporting requirements of Section 13(d) or 13(g). To be part of such a plan or scheme, a TRS would need to be directly or indirectly used in connection with an &amp;ldquo;arrangement&amp;rdquo; to prevent the vesting of beneficial ownership by the purchaser.[[N:A TRS purchaser may be deemed to be a beneficial owner if it uses the TRS to direct the counterparty&amp;rsquo;s voting of hedged equity securities, or to pre-arrange the acquisition of such securities. Entry into a TRS solely for economic exposure to the reference security, without more, does not prevent the vesting of, or create a false appearance regarding, beneficial ownership as part of a plan or scheme to evade Section 13 reporting requirements.]]&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/exchange-act-sections-13d-13g-regulation-13d-g-beneficial-ownership-reporting#105.10" target="_blank"&gt;Question 105.10&lt;/a&gt;: With respect to a TRS, the inquiry with respect to a &amp;ldquo;plan or scheme to evade&amp;rdquo; focuses on whether the person knew or was reckless in not knowing that use of the TRS would create a false appearance or illusion that the person&amp;rsquo;s interest is economic alone.[[N: Entry into a TRS for the purpose or effect of indirectly acquiring the power to vote or a future right to acquire the reference equity security may be viewed as part of a plan or scheme to evade Section 13 reporting requirements.]]&lt;/p&gt;
&lt;h3&gt;Section 13 Reporting Obligations&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/exchange-act-sections-13d-13g-regulation-13d-g-beneficial-ownership-reporting#110.09" target="_blank"&gt;Question 110.09&lt;/a&gt;: Where: (i) an entity is formed to raise funds to acquire securities of a specific issuer and engage in an activism campaign at that issuer; and (ii) prospective investors are informed in advance of the specific purpose for which their funds will be used, including the identity of the targeted issuer, the identities of all of the entity&amp;rsquo;s investors must be disclosed in any Schedule 13D filed by that entity.[[N:Under Item 3 of Schedule 13D, if any part of the purchase price is represented by funds &amp;ldquo;obtained for the purpose of acquiring, holding, trading or voting the securities,&amp;rdquo; a description of the transaction by which the funds were obtained and the names of the parties to such transaction must be disclosed.]]&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/exchange-act-sections-13d-13g-regulation-13d-g-beneficial-ownership-reporting#110.10" target="_blank"&gt;Question 110.10&lt;/a&gt;: Instruction C to Schedule 13D lists the persons and entities in addition to the reporting person as to which Items 2 through 6 information must be provided when the reporting person is not a natural person. It is not intended to limit or substitute the information required by those Items as to the reporting person itself.&lt;/p&gt;
&lt;h3&gt;Proxy Rules&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/proxy-rules-schedules-14a14c#155.02" target="_blank"&gt;Question 155.02&lt;/a&gt;: Where: (i) an entity is formed to raise funds to acquire securities of a specific issuer and engage in a proxy solicitation to change the composition of the issuer&amp;rsquo;s board at its upcoming shareholder meeting; and (ii) prospective investors in the entity are informed in advance of the specific purpose for which their funds will be used, including the identity of the target and the purpose of the planned proxy solicitation, each investor that invested more than $500 in the entity are &amp;ldquo;participants&amp;rdquo; under Instruction 3(a)(iv) to Item 4 of Schedule 14A (a &amp;ldquo;person who finances or joins with another to finance the solicitation of proxies, except persons who contribute not more than $500 and who are not otherwise participants&amp;rdquo;) and their identities must be disclosed in the proxy statement.&lt;/p&gt;
&lt;h3&gt;Regulation Crowdfunding&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/regulation-crowdfunding#202.02" target="_blank"&gt;Question 202.02&lt;/a&gt;: The reporting obligations of an issuer who conducted a compliant Regulation Crowdfunding offering using a crowdfunding vehicle continue until there are fewer than 300 holders of record who invested in the offering, or at least one of the events in Rule 202(b)(1), (3), (4), or (5) has occurred.[[N:The events are: the issuer is required to file reports under Exchange Act Section 13(a) or 15(d); the issuer has filed, since its most recent sale of securities, the required annual reports for at least the three most recent years and has total assets that do not exceed $10,000,000; the issuer or another party repurchases all of the securities issued in reliance on Securities Act Section 4(a)(6), including any payment in full of debt securities or any complete redemption of redeemable securities; or the issuer liquidates or dissolves its business in accordance with state law.]]&lt;/p&gt;
&lt;h3&gt;Tender Offer Dissemination Rules&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/tender-offer-rules-schedules#104.03" target="_blank"&gt;Question 104.03&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.sec.gov/rules-regulations/staff-guidance/corporation-finance-interpretations/tender-offer-rules-schedules#131.04" target="_blank"&gt;Question 131.04&lt;/a&gt;: Exchange Act Rules 13e-4(e)(1) (issuer tender offers) and 14(d)-4(a) (third-party tender offers) list three methods to publish, send, or give the disclosure required by Rule 13e-4(d) and Rule 14d-6, respectively, to security holders for a tender offer in which the consideration offered consists solely of cash and/or exempt securities. This requirement may be satisfied by issuing a press release (instead of the summary newspaper advertisement contemplated by the Rules) as soon as practicable on the tender offer&amp;rsquo;s commencement date through a widely disseminated news or wire service, which contains the disclosure required by Rule 13e-4(d)(3) or Rule 14d-6(d)(2), as applicable, as well as an active hyperlink to a website address where security holders may access the tender offer materials, letter of transmittal (if any), and any other documents relating to the offer, provided that: (i) the tender offer is not subject to Rule 13e-3; and (ii) the issuer or bidder, as applicable, mails or otherwise furnishes promptly the tender offer materials to any security holder who requests such tender offer materials pursuant to the press release or otherwise.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{54296927-467C-4EB5-A2C7-8F443138E44A}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/usda-proposes-major-overhaul-of-afda-rules-in-focus-on-the-expansion-of-the</link><a10:author><a10:name>Marisa N. Bocci</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bocci-marisa-n</a10:uri><a10:email>Marisa.Bocci@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Annette E. Becker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/becker-annette-e</a10:uri><a10:email>annette.becker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Stephen Patrick</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/patrick-stephen</a10:uri><a10:email>stephen.patrick@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jeffrey C. Thomson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomson-jeffrey-c</a10:uri><a10:email>jeff.thomson@arnoldporter.com</a10:email></a10:author><title>USDA Proposes Major Overhaul of AFIDA Rules: In Focus on the Expansion of the “Significant Interest or Substantial Control” Test to Include “Beneficial Owners”</title><description>This Advisory is a companion to our June 2026 Advisory on the proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) published by the U.S. Department of Agriculture (USDA) on June 25, 2026, that would, if finalized in its current form, make significant changes to the Agricultural Foreign Investment Disclosure Act (AFIDA).&amp;nbsp;</description><pubDate>Wed, 15 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This Advisory is a companion to our &lt;a href="/en/perspectives/advisories/2026/06/usda-proposes-major-overhaul-of-afida-rules"&gt;June 2026 Advisory&lt;/a&gt;&amp;nbsp;on the proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) published by the U.S. Department of Agriculture (USDA) on June 25, 2026, that would, if finalized in its current form, make significant changes to the Agricultural Foreign Investment Disclosure Act (AFIDA). Here, we focus more closely on the proposed expanded definition of &amp;ldquo;foreign persons&amp;rdquo; subject to filing requirements under AFIDA; in particular, the addition of a brand-new &amp;ldquo;beneficial owner&amp;rdquo; definition as part of the restructured &amp;ldquo;significant interest or substantial control&amp;rdquo; test that gives the definition broader reach. Together, these changes move AFIDA away from a purely equity-based inquiry and toward a broader look at governance and operational control. These changes, if implemented, could have far-reaching consequences to companies that have never considered themselves &amp;ldquo;foreign&amp;rdquo; or had to consider the requirements of AFIDA at all. &lt;/p&gt;
&lt;h2&gt;The Existing AFIDA Framework&lt;/h2&gt;
&lt;p&gt;Before getting into what the proposed rule would add, it is worth noting the current state of the law. Under AFIDA, foreign persons that acquire or transfer any interest in agricultural land, other than a security interest, are required to file a report to the Secretary of Agriculture no later than 90 days following such acquisition or transfer. 7 U.S. Code &amp;sect; 3501(a). A &amp;ldquo;foreign person&amp;rdquo; is defined to include (1) any individual who is not either a citizen of the United States, the Northern Mariana Islands or the Trust Territory of the Pacific Islands or who is not lawfully admitted to the United States for permanent residence, or paroled in the United States, under the Immigration and Nationality Act; (2) any person,[[N: A &amp;ldquo;person&amp;rdquo; includes any individual, corporation, company, association, firm, partnership, society, joint stock company, trust, estate, or any other legal entity. 7 U.S. Code &amp;sect; 3508(4).]] other than an individual or a government, which is created or organized under the laws of a foreign government or which has its principal place of business located outside of the United States; (3) any person, other than an individual or government, which is organized under the laws of any state and in which, a significant interest or substantial control is directly or indirectly held by any individual referenced in (1) or (2) above, a foreign government or, by any combination of such individuals, persons or governments; or (4) any foreign government. 7 U.S. Code &amp;sect; 3508(3). &lt;/p&gt;
&lt;p&gt;The existing regulations define &amp;ldquo;significant interest or substantial control&amp;rdquo; through three equity-based tests: a single foreign person or government holding 10% or more of an entity; multiple foreign persons acting in concert who together reach 10% or more, even if none of them individually crosses that line; or foreign persons or governments who are not acting in concert but who nonetheless hold 50% or more of the entity in the aggregate. 7 C.F.R. &amp;sect; 781.2(k). Notably, none of these prongs speak to control of the agricultural land. Accordingly, control without equity has, until now, simply not been something AFIDA reaches. The proposed &amp;ldquo;beneficial owner&amp;rdquo; definition, discussed below, is the USDA&amp;rsquo;s mechanism for closing that gap by making control, on its own, an independent trigger for AFIDA reporting.&lt;/p&gt;
&lt;h2&gt;The Proposed &amp;ldquo;Beneficial Owner&amp;rdquo; Definition&lt;/h2&gt;
&lt;p&gt;Section 5100.2(d) of the proposed rule adds a new prong to the &amp;ldquo;significant interest or substantial control&amp;rdquo; test for persons defined as &amp;ldquo;beneficial owners.&amp;rdquo; The proposed definition of a beneficial owner is: &amp;ldquo;[A]ny foreign person who, directly or indirectly, through any contract, understanding, relationship, or other arrangement, exercises decision-making authority over the agricultural land or the legal entity holding the land, including but not limited to the power to direct the sale, lease, or use of the property.&amp;rdquo; Three features of this new definition stand out: (1) it is control-based, not equity-based; (2) the undefined scope of &amp;ldquo;decision-making authority,&amp;rdquo; and (3) &amp;ldquo;indirectly&amp;rdquo; is written to broadly capture complex ownership structures. &lt;/p&gt;
&lt;p&gt;First, by contrast to the existing law, the additional test turns on decision-making authority only regardless of whether such foreign person holds any equity interest in the underlying property. Accordingly, a foreign person with zero equity will still qualify as a beneficial owner if that person exercises the requisite authority over the land or the entity holding it. The preamble to the proposed rule illustrates the point with the board of a foreign-based nonprofit that acquires agricultural land: the board members would qualify as beneficial owners by virtue of their governance authority over the nonprofit&amp;rsquo;s policies and practices, even though none of them holds any financial interest in the land. Note that in this example it is a foreign-based board that is directing the company and not persons that are lawfully admitted to the United States for permanent residency or otherwise excluded as described above in our discussion of the existing law. This distinction is worth keeping in mind, as the new regulations appear intended to capture entities that are controlled by persons residing outside of the United States.&lt;/p&gt;
&lt;p&gt;Secondly, the phrase at the heart of the new definition, &amp;ldquo;exercises decision-making authority through any contract, understanding, relationship, or other arrangement,&amp;rdquo; is left undefined in the proposed rule, and that gap leaves several interpretive questions open during the comment period. It is not clear whether customary passive-investor protective rights held by foreign limited partners or joint venture partners, such as budget approvals, major-decision consents, removal-for-cause provisions, and transfer restrictions, would count as decision-making authority over the land. It is likewise unclear whether the concept is limited to operational control over the actual use and disposition of the property, or whether it extends further to governance-level approval rights that constrain property decisions without affirmatively directing them. Further, would the inclusion of one or more foreign persons on the board of directors of a U.S. company constitute foreign persons having decision-making authority given that they have input (even if they do not have the ability to act on their own accord)? These are all questions that remain unanswered based on the current language set forth in the proposed rule. Because the proposed rule includes no safe harbor for customary protective rights or de minimis input, investors and practitioners structuring any transaction involving agricultural land with foreign participation are left with real uncertainty about where the line falls.&lt;/p&gt;
&lt;p&gt;Finally, the definition is written to reach through every layer of intermediary ownership, and it calls out circular ownership, shell corporations, trusts, and partnerships by name so that structuring around the rule through layered entities does not work. &lt;/p&gt;
&lt;h2&gt;Other Changes to the &amp;ldquo;Significant Interest or Substantial Control&amp;rdquo; Definition&lt;/h2&gt;
&lt;p&gt;Section 5100.2(p) of the proposed rule rebuilds &amp;ldquo;significant interest or substantial control&amp;rdquo; into three separate channels, and satisfying any one of them is enough to make a domestic entity a &amp;ldquo;foreign person&amp;rdquo; under AFIDA. &lt;/p&gt;
&lt;p&gt;First, the equity-based test currently in place (the 10% alone, 10% acting in concert, or 50% in the aggregate described above) is replaced with a flat 10% or greater interest in the aggregate, whether or not acting in concert. The second is the &amp;ldquo;beneficial owners&amp;rdquo; prong discussed in detail herein. The third is an adversary-based prong, which includes any interest held by a foreign adversary or a Foreign Adversary Controlled Entity, with no percentage floor.&lt;/p&gt;
&lt;h2&gt;How the &amp;ldquo;Beneficial Owners&amp;rdquo; Definition Differs From the SEC and CTA Beneficial Ownership Frameworks&lt;/h2&gt;
&lt;p&gt;The preamble of the proposed rule acknowledges that other federal regulations already use the phrase &amp;ldquo;beneficial ownership&amp;rdquo; in different ways, and it takes care to distinguish the AFIDA proposal from the best-known of those frameworks, SEC Rule 13d-3. Under the securities rule, beneficial ownership of a security turns on whether a person has or shares voting or investment power, meaning the ability to dispose of the security or direct its disposition.&lt;/p&gt;
&lt;p&gt;The proposed AFIDA definition is broader than the SEC test. The SEC&amp;rsquo;s test is securities-centric: it asks who can vote or dispose of shares. The AFIDA test is asset-centric in that it asks who can direct the sale, lease, or use of real property, whether or not that person holds any equity or voting rights at all. Based on the text of the proposed rule, a person can qualify as an AFIDA beneficial owner purely through a management agreement, a governance document, or some other contractual arrangement that hands them operational authority over the land.&lt;/p&gt;
&lt;p&gt;The proposal appears to have conceptual roots in the Corporate Transparency Act&amp;rsquo;s (CTA) &amp;ldquo;substantial control&amp;rdquo; test administered by FinCEN, which is similarly broad. &amp;ldquo;Substantial control&amp;rdquo; under the CTA includes anyone who exercises substantial control over an entity through a senior officer position, has the ability to appoint or remove senior officers, has substantial influence over company decisions, or has any other form of substantial control. Like the definition in the proposed AFIDA rule, &amp;ldquo;substantial control&amp;rdquo; requires no ownership interest and there is no cap on how many people can qualify. 31 C.F.R. &amp;sect; 1010.380. However, the two frameworks diverge in scope. The CTA test is entity-focused, looking only at control over the reporting company (which, per current FinCEN rules, only includes entities formed outside of the United States), while the AFIDA proposal extends to control over either the entity (including domestic entities) or the land itself.&lt;/p&gt;
&lt;h2&gt;Roles and Structures That May Be Captured Under the &amp;ldquo;Beneficial Owners&amp;rdquo; Definition&lt;/h2&gt;
&lt;p&gt;Every category discussed below is subject to one threshold qualifier: the person holding the role has to be a &amp;ldquo;foreign person.&amp;rdquo; With that qualifier in mind, several familiar roles could end up captured. A foreign director sitting on the board of directors of a U.S.-based organization who has governance authority over the entity that holds the land, including the power to approve or direct dispositions, leases, or changes in use, could fall within the definition. A foreign senior officer, such as a Chief Operating Officer or Chief Financial Officer with operational authority over how the property is used or disposed of, may likewise qualify if that person can direct the sale, lease, or use of the property. A foreign asset or investment manager holding contractual authority under a management or advisory agreement to direct acquisitions, dispositions, leasing, or use of the land could also be captured. The same logic applies to a foreign general partner who controls a fund or partnership holding agricultural land, even with zero or nominal equity. And, lastly, a foreign joint-venture partner or managing member with major-decision rights, approval or veto rights over sales, leases, or use of the land, or the ability to remove and replace a manager, could qualify based on control alone, even at an equity stake well below 10%.&lt;/p&gt;
&lt;h2&gt;Practical Implications for Deal Due Diligence and Documentation&lt;/h2&gt;
&lt;p&gt;The shift of the proposed rule from an equity-based test to a control-based test changes what AFIDA due diligence needs to cover. Historically, confirming AFIDA status meant reviewing a cap table or ownership schedule for foreign holders above the relevant equity thresholds. Under the proposed rule, that review would need to extend to governance and contractual control as well, including board composition, officer appointments, management and advisory agreements, and consent, veto, or removal rights held by foreign parties, regardless of their equity stake. The conceptual overlap with CFIUS&amp;rsquo; own control-based jurisdictional test should be noted. While the two regimes are administered separately and serve different purposes, entities that have already mapped their CFIUS control profile may be able to reuse much of that analysis to assess AFIDA beneficial owner exposure.&lt;/p&gt;
&lt;p&gt;Several categories of transaction documents should be reviewed in light of this proposal. Limited liability company and limited partnership agreements should be reviewed for provisions granting foreign parties major decision consent rights, board or manager designation rights, or removal for cause authority. Joint venture agreements warrant particular attention where a foreign partner holds approval rights over leasing, use, or disposition of real property, even at a minority equity stake. Investment management and advisory agreements should be checked for contractual authority over acquisition, disposition, leasing, or use decisions held by a foreign manager.&lt;/p&gt;
&lt;p&gt;Parties negotiating acquisitions, financings, or joint ventures involving agricultural land should also consider whether AFIDA-specific representations, warranties, and closing conditions are warranted, similar to how deal documents were revised to address beneficial ownership certifications after the CTA took effect. This could include representations regarding the foreign person status of beneficial owners as newly defined, covenants to notify counterparties of changes in control that could trigger a filing obligation, and closing conditions tied to completion of any required AFIDA report.&lt;/p&gt;
&lt;h2&gt;Key Takeaways&lt;/h2&gt;
&lt;p&gt;Taken together, the proposed rule marks a fundamental shift in how AFIDA identifies a &amp;ldquo;foreign person.&amp;rdquo; Where the existing framework asks only who holds equity, the new &amp;ldquo;beneficial owner&amp;rdquo; prong asks who holds control. Accordingly, decision-making authority over agricultural land or the entity that holds it is now an independent, standalone trigger for filing, wholly apart from any ownership stake. Companies and investors with foreign participation anywhere in their governance or management structure (even those that have never before considered themselves &amp;ldquo;foreign&amp;rdquo; for AFIDA purposes) should evaluate the impacts of the proposed rule.&lt;/p&gt;
&lt;p&gt;The comment period on the proposed rule closes on August 10, 2026. We are continuing to monitor developments and can assist with assessing exposure, structuring analysis, and preparing public comments.&lt;/p&gt;
&lt;p&gt;This Advisory is for informational purposes only and does not constitute legal advice.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{61BA732B-6908-49DC-9D54-6F71E7E50717}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/amb-barbara-leaf-joins-bbc-news-to-discuss-diplomatic-outlook-of-us-iran-conflict</link><title>Amb. Barbara Leaf Joins BBC News to Discuss Diplomatic Outlook of U.S.-Iran Conflict</title><description>&lt;p&gt;Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf joined &lt;em&gt;BBC News&lt;/em&gt; to discuss the latest U.S. strikes on Iran, Tehran's threat to close the Strait of Hormuz, and ongoing efforts to negotiate an end to the conflict.&lt;/p&gt;</description><pubDate>Tue, 14 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf joined &lt;em&gt;BBC News&lt;/em&gt; to discuss the latest U.S. strikes on Iran, Tehran's threat to close the Strait of Hormuz, and ongoing efforts to negotiate an end to the conflict.&lt;/p&gt;
&lt;p&gt;Amb. Leaf explained that this week's U.S. military response appears intended to restore deterrence while avoiding a broader regional conflict, while underscoring the tenuous nature of the ceasefire that has kept the Strait of Hormuz open in a limited capacity. "The ceasefire has been exceptionally fragile since its inception," she observed.&lt;/p&gt;
&lt;p&gt;Turning to diplomacy, Amb. Leaf described negotiations between the United States and Iran as a work in progress, with "fierce" diplomatic activity underway. She noted, however, that the gap between the parties remains "quite wide," explaining that the United States is relying on its overwhelming military capability to bring Iran to the negotiating table while cautioning that the Iranian government is unlikely to be compelled by military pressure alone.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{2EE47157-475C-4785-84C6-9CD0A2AE0D1A}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/the-end-of-for-cause-removal-supreme-court-reshapes-removal-protections</link><a10:author><a10:name>Veronica E. Callahan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/callahan-veronica-rendn</a10:uri><a10:email>veronica.callahan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John P. Elwood</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/elwood-john-p</a10:uri><a10:email>john.elwood@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kathleen Reilly</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/reilly-kathleen</a10:uri><a10:email>kathleen.reilly@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Stephanna F. Szotkowski</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/szotkowski-stephanna</a10:uri><a10:email>stephanna.szotkowski@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Adrien K. Anderson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/anderson-adrien-k</a10:uri><a10:email>adrien.anderson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>James Moes</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/moes-james</a10:uri><a10:email>james.moes@arnoldporter.com</a10:email></a10:author><title>The End of For-Cause Removal? Supreme Court Reshapes Removal Protections for Independent Agency Leadership</title><description>On June 29, 2026, the U.S. Supreme Court issued two decisions addressing the president&amp;rsquo;s power to remove appointed federal officials, which will likely have dramatic implications for a broad range of federal independent agencies and the U.S. regulatory landscape.&amp;nbsp;</description><pubDate>Tue, 14 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 29, 2026, the U.S. Supreme Court issued two decisions addressing the president&amp;rsquo;s power to remove appointed federal officials, which will likely have dramatic implications for a broad range of federal independent agencies and the U.S. regulatory landscape. &lt;/p&gt;
&lt;p&gt;In &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/25-332_qn12.pdf" target="_blank"&gt;Trump v. Slaughter&lt;/a&gt;&lt;/em&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/25-332_qn12.pdf" target="_blank"&gt;, 609 U.S. ___ (2026)&lt;/a&gt;, the Court held that the statutory &amp;ldquo;for cause&amp;rdquo; removal protection afforded to Commissioners of the Federal Trade Commission (FTC) violates the Constitution&amp;rsquo;s separation of powers.[[N: &lt;em&gt;Trump v. Slaughter&lt;/em&gt;, No. 25-332, slip op. at 2 (June 29, 2026) (quoting 15 U.S.C. &amp;sect; 41).]] This decision overturned foundational precedent in &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://tile.loc.gov/storage-services/service/ll/usrep/usrep295/usrep295602/usrep295602.pdf" target="_blank"&gt;Humphrey&amp;rsquo;s Executor v. United States&lt;/a&gt;&lt;/em&gt; that for nine decades has shielded heads of independent regulatory agencies from presidential removal at will.[[N: See &lt;em&gt;Humphrey&amp;rsquo;s Ex&amp;rsquo;r v. United States&lt;/em&gt;, 295 U.S. 602 (1935).]] The &lt;em&gt;Slaughter&lt;/em&gt; case broadly reshapes the constitutional architecture of federal independent agencies and substantially weakens the statutory insulation from at-will removal of agency heads. Notably, the dissenting opinion warned that &amp;ldquo;dozens&amp;rdquo; of such agencies are &amp;ldquo;now likely to become purely executive agencies, shifting tremendous power over broad swaths of American life into the President&amp;rsquo;s hands.&amp;rdquo;[[N: &lt;em&gt;Slaughter&lt;/em&gt;, slip. op. at 38 (Sotomayor, J., dissenting).]]&lt;/p&gt;
&lt;p&gt;Despite the expansion of the president&amp;rsquo;s power to remove appointed officials at will in &lt;em&gt;Slaughter&lt;/em&gt;, the &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/25a312_5468.pdf" target="_blank"&gt;Court in Trump v. Cook&lt;/a&gt;&lt;/em&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/25a312_5468.pdf" target="_blank"&gt;, 609 U.S. ____ (2026)&lt;/a&gt;, specifically carved out the Board of Governors of the Federal Reserve System (the Federal Reserve) from the &lt;em&gt;Slaughter&lt;/em&gt; decision, leaving intact for-cause protection afforded to Federal Reserve Governors. Although the Court denied the stay on the narrow ground that Governor Cook had not received the process required by statute, the majority also expressly held that the Federal Reserve&amp;rsquo;s for-cause removal protection is consistent with Article II. The Court left unresolved whether the alleged conduct ultimately constitutes cause for Governor Cook&amp;rsquo;s removal. &lt;/p&gt;
&lt;p&gt;While the Court&amp;rsquo;s &lt;em&gt;Cook &lt;/em&gt;decision is in tension with the &lt;em&gt;Slaughter&lt;/em&gt; decision, the unique circumstances identified by the Court in &lt;em&gt;Cook&lt;/em&gt; suggest a narrow limitation whose application beyond the Federal Reserve remains uncertain. As such, the &lt;em&gt;Slaughter&lt;/em&gt; decision likely provides the presumptive legal precedent for agency independence.&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;Trump v. Slaughter&lt;/em&gt;: New Precedent for Independent Federal Agencies&lt;/h2&gt;
&lt;p&gt;In March 2025, President Trump fired the FTC&amp;rsquo;s two Democratic Commissioners without asserting any statutorily required grounds.  Instead, the president stated that he was removing them because he believed that their continued service was inconsistent with his administration&amp;rsquo;s priorities, invoking his authority under Article II of the Constitution. Rebecca Slaughter, one of the two removed Democratic Commissioners, filed suit against the president seeking injunctive relief to restore her to office.&lt;/p&gt;
&lt;h3&gt;The Majority Opinion&lt;/h3&gt;
&lt;p&gt;The case presented a foundational question of executive power: whether the president has the authority to fire officials at independent federal agencies at will. In the 6-3 ruling, with Chief Justice Roberts writing for the majority, the Court held that heads of multi-member independent agencies who exercise executive power &amp;mdash; including rulemaking, adjudication, and civil enforcement power &amp;mdash; may be removed by the president at will, without the &amp;ldquo;for cause&amp;rdquo; protection provided by Congress. The Court grounded its analysis in Article II of the Constitution, which vests executive power in the president and instructs the president to &amp;ldquo;take Care that the Laws be faithfully executed.&amp;rdquo;[[N: &lt;em&gt;Slaughter&lt;/em&gt;, slip op. at 4.]] The Court explained that, because subordinate officers exist to assist the president in discharging that duty, they must remain accountable to the president &amp;mdash; and removal power is the mechanism that enforces that accountability.&lt;/p&gt;
&lt;p&gt;Addressing applicable precedent, the Court reaffirmed &lt;em&gt;Myers v. United States&lt;/em&gt;,[[N: &lt;em&gt;Myers v. United States&lt;/em&gt;, 272 U.S. 52 (1926).]] which held that the president&amp;rsquo;s removal power flows directly from Article II and does not depend on any subsequent statute. The Court overturned &lt;em&gt;Humphrey&amp;rsquo;s Executor&lt;/em&gt;, which permitted for-cause removal protection for the FTC in 1935, on the theory that FTC Commissioners performed only &amp;ldquo;quasi-legislative&amp;rdquo; and &amp;ldquo;quasi-judicial&amp;rdquo; functions rather than exercising &amp;ldquo;executive power.&amp;rdquo; The Court concluded that this characterization of the FTC, as exercising &amp;ldquo;no part of the executive power,&amp;rdquo; &amp;ldquo;has not withstood the test of time.&amp;rdquo;[[N: &lt;em&gt;Slaughter&lt;/em&gt;, slip op. at 18, 21.]] In coming to its decision, the Court noted that later decisions have progressively recognized that such functions are, in fact, executive.[[N: Id. at 18-20 (citing &lt;em&gt;Morrison v. Olson&lt;/em&gt;, 487 U.S. 654 (1988); &lt;em&gt;Free Enter. Fund v. PCAOB&lt;/em&gt;, 561 U.S. 477 (2010); &lt;em&gt;Seila Law LLC v. CFPB&lt;/em&gt;, 140 S. Ct. 2183 (2020)).]] Weighing traditional &lt;em&gt;stare decisis&lt;/em&gt; factors, the Court found that the &amp;ldquo;quality&amp;rdquo; of the &lt;em&gt;Humphrey&amp;rsquo;s&lt;/em&gt; reasoning, its &amp;ldquo;consistency&amp;rdquo; with later cases, its &amp;ldquo;workability,&amp;rdquo; and the reliance interests at stake all favored overruling it.[[N: Id. at 21-22.]]&lt;/p&gt;
&lt;p&gt;Applying this framework, the Court held that the FTC &amp;ldquo;unquestionably exercises executive power,&amp;rdquo; pointing to its authority to promulgate rules carrying the force of law, conduct in-house adjudications backed by penalty authority, and file civil suits on behalf of the United States.[[N: Id. at 25-27.]] The Court concluded that these functions are &amp;ldquo;the very essence of &amp;lsquo;execution&amp;rsquo; of the law,&amp;rdquo; and Commissioners exercising these functions must therefore be removable by the president at will and without statutory limitation.[[N: Id. at 25, 27 (quoting &lt;em&gt;Bowsher v. Synar&lt;/em&gt;, 478 U.S. 714, 733 (1986)).]]&lt;/p&gt;
&lt;h3&gt;Concurrence &lt;/h3&gt;
&lt;p&gt;While agreeing that principal officers exercising executive power must be removable at will, Justice Gorsuch&amp;rsquo;s concurrence warned that independent agencies exercise not just executive power, but &amp;ldquo;vast legislative and judicial powers,&amp;rdquo; and that, after the &lt;em&gt;Slaughter&lt;/em&gt; decision, the president now &amp;ldquo;can effectively exercise all those powers too.&amp;rdquo;[[N: Id. at 1 (Gorsuch, J., concurring).]] Justice Gorsuch observed that agencies like the U.S. Securities and Exchange Commission (SEC) hold sweeping rulemaking authority &amp;mdash; citing its power to make such rules and regulations as necessary or appropriate to fulfill its mandate of ensuring fair and honest markets &amp;mdash; and pointed to the SEC&amp;rsquo;s 2024 climate-disclosure rules as a recent example of that authority in use.[[N: The SEC recently &lt;a rel="noopener noreferrer" href="https://www.sec.gov/newsroom/press-releases/2026-49-sec-proposes-rescission-climate-related-disclosure-rules" target="_blank"&gt;issued a proposal &lt;/a&gt;seeking to rescind these rules.]] Gorsuch also raised the prospect of what may occur when a business faces coordinated pressure from enforcement, rulemaking, and adjudication acting in concert, warning that these &amp;ldquo;now-coordinated powers&amp;rdquo; could be turned against &amp;ldquo;disfavored&amp;rdquo; individuals or entities, and suggesting that doctrines like nondelegation and the major questions doctrine may need to bear more weight going forward as a check on that combined power.[[N: See id. at 8, 11, 14-15.]]&lt;/p&gt;
&lt;h3&gt;Dissent&lt;/h3&gt;
&lt;p&gt;Justice Sotomayor&amp;rsquo;s dissenting opinion (joined by Justices Kagan and Jackson) stated that the decision &amp;ldquo;undoes centuries of political practice&amp;rdquo; and elevates the president &amp;ldquo;above his once-coequal branches.&amp;rdquo;[[N: Id. at 2 (Sotomayor, J., dissenting).]] The dissenting justices argued the case should have begun and ended with &lt;em&gt;Humphrey&amp;rsquo;s Executor&lt;/em&gt;, which addressed the same statute under nearly identical circumstances. The dissent maintained that &amp;ldquo;[90] years of precedent and 140 years of consistent political practice should have been more than enough to resolve this case,&amp;rdquo; and neither the nation&amp;rsquo;s founding nor the Constitution&amp;rsquo;s text and structure prohibit for-cause removal protections.[[N: Id. at 13-14.]] Significantly, the dissent identified several agencies likely transformed by the decision, and noted that the government itself conceded at oral argument that the &amp;ldquo;logic&amp;rdquo; of its position &amp;ldquo;extends to inferior officers and, perhaps, career civil servants, too&amp;rdquo; &amp;mdash; a concession the majority&amp;rsquo;s holding does not disavow.[[N: Id. at 38, 45.]]&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;Trump v. Cook&lt;/em&gt;: A Different Result for the Federal Reserve&lt;/h2&gt;
&lt;p&gt;Notably, the Court&amp;rsquo;s &lt;em&gt;Slaughter&lt;/em&gt; opinion explicitly states that the decision does not &amp;ldquo;implicate the constitutionality&amp;rdquo; of the Federal Reserve, thereby distinguishing the Court&amp;rsquo;s decision in &lt;em&gt;Slaughter&lt;/em&gt; from &lt;em&gt;Cook&lt;/em&gt;.&lt;/p&gt;
&lt;h3&gt;Background&lt;/h3&gt;
&lt;p&gt;In 2022, President Biden appointed Lisa Cook to the Board of the Federal Reserve to complete former Federal Reserve Chair Janet Yellen&amp;rsquo;s unexpired term, and in 2023 reappointed Cook to a full 14-year term set to expire in 2038.[[N: &lt;em&gt;Trump v. Cook&lt;/em&gt;, No. 25A312, slip op. at 6 (June 29, 2026). The Federal Reserve Act of 1913 established the Federal Reserve Board whose seven members are appointed by the president and confirmed by the Senate to serve staggered fourteen-year terms. 12 U.S.C. &amp;sect; 241. The statute also provides that Federal Reserve Governors may be removed only &amp;ldquo;for cause.&amp;rdquo; 12 U.S.C. &amp;sect; 242.]] In August 2025, the Director of the Federal Housing Finance Agency publicly accused Governor Cook of committing mortgage fraud years before she joined the Federal Reserve Board. President Trump publicly called for Governor Cook&amp;rsquo;s resignation, and days later purported to fire her &amp;ldquo;for cause,&amp;rdquo; stating that he lacked confidence in her integrity.[[N: &lt;em&gt;Cook&lt;/em&gt;, slip op. at 6-7.]] This was the first time in the Federal Reserve&amp;rsquo;s 111-year history that a president had attempted to fire a Federal Reserve Governor.[[N: Id. at 1.]]&lt;/p&gt;
&lt;p&gt;Governor Cook sued, arguing that her alleged conduct did not constitute &amp;ldquo;cause,&amp;rdquo; and that she was statutorily and constitutionally entitled to notice and an opportunity to respond before removal, which she never received. The District Court agreed and entered a preliminary injunction preventing the removal from taking effect and requiring the Federal Reserve Board to allow Cook to remain in office pending the litigation. The Court of Appeals declined to stay the injunction, and the government appealed to the Supreme Court for a stay pending appeal &amp;mdash; not final merits review, but an order that would have permitted Governor Cook&amp;rsquo;s removal to take effect while the underlying suit proceeded.&lt;/p&gt;
&lt;h3&gt;The Majority Opinion &lt;/h3&gt;
&lt;p&gt;Writing for a 5-4 majority (joined by Justices Sotomayor, Kagan, Kavanaugh, and Jackson), Chief Justice Roberts denied the government&amp;rsquo;s stay application, holding that it had not shown a likelihood of success on the merits.[[N: Id. at 8-9.]] In coming to this determination, the Court made three findings rejecting the government&amp;rsquo;s arguments. First, the Court found that the president&amp;rsquo;s determination of &amp;ldquo;cause&amp;rdquo; is judicially reviewable, and that neither the statute nor the common law commits that determination to the president alone. Second, the Court found that &amp;ldquo;any definition of &amp;lsquo;cause&amp;rsquo; in this context must reflect the Federal Reserve&amp;rsquo;s unique historical status and role,&amp;rdquo; which requires a &amp;ldquo;substantial threshold&amp;rdquo; showing that turns on whether the &amp;ldquo;cause assigned&amp;rdquo; truly &amp;ldquo;implies an unfitness for the place,&amp;rdquo; or is instead a pretext to secure a &amp;ldquo;more congenial&amp;rdquo; replacement.[[N: Id. at 11-15.]] Third, the Court found that federal courts retain equitable power to reinstate a wrongly removed officer pending litigation, consistent with historical practice protecting de facto officeholders until a court of law finally determines title to office.&lt;/p&gt;
&lt;p&gt;The Court ultimately made its ruling on narrow procedural grounds: that Governor Cook was entitled to notice and some opportunity to respond before removal, a right traced to the &amp;ldquo;settled interpretation at common law&amp;rdquo; for officers holding a fixed term limited only by removal for cause. The Court determined that because the president gave her no meaningful opportunity to respond, the removal could not stand on the record presented.&lt;/p&gt;
&lt;p&gt;Importantly, the Court separately affirmed that the Federal Reserve&amp;rsquo;s removal protection is consistent with Article II, tracing its independence to the historical tradition of the First and Second Banks of the United States and emphasizing that &amp;ldquo;[n]ot only the fact of independence but also the appearance of independence is key to the Federal Reserve&amp;rsquo;s design.&amp;rdquo;[[N: Id. at 14, 22-24.]] The Court expressly left open whether Governor Cook&amp;rsquo;s alleged conduct could ultimately satisfy &amp;ldquo;cause&amp;rdquo; once she receives proper process, and noted the president remains free to try again if he affords her adequate notice and an opportunity to respond.&lt;/p&gt;
&lt;h3&gt;Concurrences&lt;/h3&gt;
&lt;p&gt;Justice Kavanaugh, concurring, wrote separately to stress his agreement with the majority in its decision to not leave open the question as to whether the Federal Reserve should remain independent after &lt;em&gt;Slaughter&lt;/em&gt;, warning that &amp;ldquo;even temporary uncertainty about the status of the Federal Reserve could spark political upheaval, including confusion about whether the president could immediately remove multiple governors at will, as well as turmoil in the U.S. and world economies.&amp;rdquo;[[N:&amp;nbsp;Id. at 2 (Kavanaugh, J., concurring).]] Justice Jackson, also concurring, wrote separately, concluding that the government had identified no cognizable injury from Governor Cook&amp;rsquo;s continued service. She further concluded that &amp;ldquo;the public&amp;rsquo;s interest is not served if a President can intimidate members of the Federal Reserve into doing his bidding,&amp;rdquo; and weighed decisively against a stay.[[N: Id. at 3 (Jackson, J., concurring).]]&lt;/p&gt;
&lt;h3&gt;Dissents&lt;/h3&gt;
&lt;p&gt;Justice Thomas dissented, arguing that the Federal Reserve Board &amp;ldquo;unquestionably exercises executive power&amp;rdquo; &amp;mdash; invoking the majority&amp;rsquo;s own language from&lt;em&gt; Slaughter &lt;/em&gt;&amp;mdash; and should therefore be subject to at-will removal without exception.[[N: Id. at 25 (Thomas, J., dissenting) (quoting &lt;em&gt;Slaughter&lt;/em&gt;, slip op. at 25).]] He rejected the majority&amp;rsquo;s analogy to the First and Second Banks as ahistorical, arguing that those banks, unlike the modern Federal Reserve, exercised no executive power and were privately run institutions with only incidental government involvement. Justice Alito, joined by Justice Gorsuch, also dissented, but on narrower procedural grounds, criticizing the majority for resolving numerous unsettled and complex legal questions on an underdeveloped record at an early, interim stage of the litigation, rather than limiting review to the two issues actually decided below.[[N: Id. at 1-4 (Alito, J., dissenting).]] Justice Barrett, dissenting separately, objected specifically to the majority reaching the constitutionality of the Federal Reserve&amp;rsquo;s removal protections at all.[[N: Id. at 1-2 (Barrett, J., dissenting).]] She also warned that the majority&amp;rsquo;s carve-out sits in &amp;ldquo;serious tension&amp;rdquo; with &lt;em&gt;Slaughter&lt;/em&gt;&amp;rsquo;s categorical rule that any agency executing a mandate against private parties exercises executive power.&lt;/p&gt;
&lt;h2&gt;Impact of &lt;em&gt;Slaughter &lt;/em&gt;and &lt;em&gt;Cook&lt;/em&gt; on Independent Agencies and Regulated Entities&lt;/h2&gt;
&lt;p&gt;Read together, &lt;em&gt;Cook &lt;/em&gt;and &lt;em&gt;Slaughter&lt;/em&gt; provide the loose outlines of a new framework regarding the president&amp;rsquo;s removal power. &lt;em&gt;Slaughter&lt;/em&gt; sets forth the default: heads of independent, multi-member agencies that exercise executive power are now removable by the president at will. &lt;em&gt;Cook&lt;/em&gt; confirms that this default is not universal, carving out the Federal Reserve based on its unique historical status and role rather than any functional distinction from agencies like the FTC. As Justice Kavanaugh&amp;rsquo;s concurrence makes clear, the Court treated this clarification as to the applicability of&lt;em&gt; Slaughter&lt;/em&gt; to the Federal Reserve as urgent, resolving &lt;em&gt;Cook&lt;/em&gt; the same day to avoid leaving the Federal Reserve&amp;rsquo;s status in doubt and destabilizing its independence. Even so, the two decisions sit in tension. Read together, &lt;em&gt;Slaughter &lt;/em&gt;and &lt;em&gt;Cook&lt;/em&gt; establish a general rule with a historically grounded exception. &lt;em&gt;Slaughter &lt;/em&gt;holds that officials within the president&amp;rsquo;s general administrative control who exercise executive power generally must be removable at will. &lt;em&gt;Cook&lt;/em&gt; holds that Federal Reserve Governors may retain for-cause protection because of the Federal Reserve&amp;rsquo;s distinctive historical tradition, structure, and monetary-policy role. The decisions leave uncertain whether any other entity or function has a comparably distinctive historical footing.&lt;/p&gt;
&lt;p&gt;For regulated entities, the practical takeaway is straightforward: &lt;em&gt;Slaughter&lt;/em&gt;, not &lt;em&gt;Cook&lt;/em&gt;, provides the rule of general application. Financial market regulators such as the SEC and the Commodity Futures Trading Commission (CFTC) are materially indistinguishable from the FTC for purposes of this analysis, and their Commissioners&amp;rsquo; removal protections rest on the same, now-overruled precedent. This shift likely has no immediate practical effect at the SEC or the CFTC &amp;mdash; as both currently have no sitting Democratic Commissioners. It nevertheless creates the possibility of sudden removals in the future and should inform how regulated entities plan going forward.&lt;/p&gt;
&lt;p&gt;What this means is hard to predict, but it is possible that entities regulated by the SEC and/or CFTC will see faster and less predictable shifts in enforcement priorities, rulemaking agendas, and policy positions, particularly as commission composition becomes easier for a president to reshape mid-term. Regulated entities should pay close attention to how the political pressures and media scrutiny surrounding any administration&amp;rsquo;s relationship with its appointees may translate into abrupt reversals of guidance, no-action positions, and enforcement priorities and strategies.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;*	*	*&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter continues to monitor administrative and regulatory shifts at the U.S. market regulators. Please reach out to the authors of this Advisory or your regular Arnold &amp;amp; Porter contact for additional information. &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8066C5FA-354D-4416-92E7-1C9A12B1279B}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/the-end-of-the-ats-road-supreme-court-limits-international-human-rights-lawsuits-in-us-courts</link><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>R. Reeves Anderson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/anderson-r-reeves</a10:uri><a10:email>reeves.anderson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sally Pei</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pei-sally</a10:uri><a10:email>sally.pei@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Volodymyr Ponomarov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/ponomarov-volodymyr</a10:uri><a10:email>volodymyr.ponomarov@arnoldporter.com</a10:email></a10:author><title>The End of the ATS Road? Supreme Court Limits International Human Rights Lawsuits in U.S. Courts</title><description>On June 23, 2026, the U.S. Supreme Court ruled in &lt;em&gt;Cisco Systems, Inc. v. Doe&lt;/em&gt; that federal courts may not create new causes of action under the Alien Tort Statute (ATS), the 1789 statute that gives federal courts jurisdiction over tort suits by foreign nationals for violations of international law.</description><pubDate>Tue, 14 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 23, 2026, the U.S. Supreme Court ruled in &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/24-856_kjfm.pdf" target="_blank"&gt;Cisco Systems, Inc. v. Doe&lt;/a&gt;&lt;/em&gt; that federal courts may not create new causes of action under the Alien Tort Statute (ATS), the 1789 statute that gives federal courts jurisdiction over tort suits by foreign nationals for violations of international law. The Court also held that the Torture Victim Protection Act of 1991 (TVPA) does not provide for aiding-and-abetting liability. &lt;em&gt;Cisco&lt;/em&gt; is the most significant ATS ruling in years: it effectively ends modern ATS litigation that has often targeted U.S. businesses operating in high-risk jurisdictions abroad with claims based on human rights violations committed by foreign governments or third parties.&lt;/p&gt;
&lt;p&gt;For nearly half a century, beginning with the Second Circuit&amp;rsquo;s seminal decision in &lt;em&gt;Fil&amp;aacute;rtiga v. Pe&amp;ntilde;a-Irala&lt;/em&gt;, foreign plaintiffs have invoked the ATS to sue hundreds of U.S. and international defendants for violations of international law abroad, such as torture, extrajudicial killing, forced labor, arbitrary detention, and forced disappearance. In &lt;em&gt;Sosa v. Alvarez-Machain&lt;/em&gt;, the Supreme Court gave ATS litigation a limited stamp of approval. Although the Court held that the ATS is a jurisdictional statute and creates no new causes of action beyond the limited violations of international law that were widely recognized and accepted in 1789, it allowed federal courts to recognize a narrow class of claims based on modern international law norms under two conditions: (1) the relevant international law norm must have &amp;ldquo;definite content and acceptance among civilized nations&amp;rdquo; equivalent to the 1789 norms; and (2) the judiciary must exercise its discretion narrowly (described as &amp;ldquo;vigilant doorkeeping&amp;rdquo;) to ensure that any new ATS claim does not infringe upon the executive&amp;rsquo;s foreign relations prerogatives. After&lt;em&gt; Sosa&lt;/em&gt;, plaintiffs filed over 150 lawsuits under the ATS invoking an array of alleged modern international law norms.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Sosa&lt;/em&gt;&amp;rsquo;s framework was controversial from the start, and the Court has consistently narrowed the ATS in the two decades that followed. We have written extensively about the various limitations the Court has imposed on ATS suits, including that ATS claims are subject to the presumption against extraterritoriality (&lt;em&gt;&lt;a rel="noopener noreferrer" href="https://instituteforlegalreform.com/research/as-kiobel-turns-one-its-effect-remains-unclear/" target="_blank"&gt;Kiobel v. Royal Dutch Petroleum&lt;/a&gt;&lt;/em&gt;); foreign corporations cannot be sued under the ATS (&lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.lawfaremedia.org/article/jesner-v-arab-bank-supreme-court-should-not-miss-opportunity-clarify-touch-and-concern-test" target="_blank"&gt;Jesner v. Arab Bank&lt;/a&gt;&lt;/em&gt;); and allegations of general corporate activity in the United States are not enough to establish a domestic application of the statute (&lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.lawfaremedia.org/article/doe-v-nestle-ats-case-dismissed-again" target="_blank"&gt;Nestl&amp;eacute; v. Doe&lt;/a&gt;&lt;/em&gt;). &lt;/p&gt;
&lt;p&gt;In &lt;em&gt;Cisco&lt;/em&gt;, the Court delivered what may be the final blow to modern ATS litigation. Although &lt;em&gt;Cisco&lt;/em&gt; did not disturb the narrow historical categories of ATS claims recognized in &lt;em&gt;Sosa&lt;/em&gt; &amp;mdash; assaults on ambassadors, violations of safe conduct, and piracy &amp;mdash; those categories have played little role in modern ATS litigation. The practical effect is that, after &lt;em&gt;Cisco&lt;/em&gt;, foreign plaintiffs may no longer rely on the ATS to sue for international human rights law violations in U.S. courts. It remains to be seen how the plaintiffs&amp;rsquo; bar will respond &amp;mdash; including whether they will seek remedies under state law, foreign law, or federal statutes such as the TVPA, the Anti-Terrorism Act (ATA), or the Trafficking Victims Protection Reauthorization Act (TVPRA), each of which has its own limitations. &lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;&lt;em&gt;Cisco&lt;/em&gt; involved allegations that members of Falun Gong, a Chinese religious movement, were persecuted by the Chinese government for their religious beliefs and that Cisco helped enable that persecution by developing surveillance technology used to identify and apprehend them. Plaintiffs sued Cisco and several executives under the ATS in a federal court in California. Plaintiffs alleged that Cisco and its executives aided and abetted violations of international law, including torture; cruel, inhuman, or degrading treatment; forced labor; prolonged and arbitrary detention; crimes against humanity; extrajudicial killing; and forced disappearance. One plaintiff (a U.S. citizen who could not sue under the ATS) alleged that two Cisco executives were liable under the TVPA for aiding and abetting torture. The district court dismissed the complaint, but the Ninth Circuit reversed in relevant part, holding that aiding-and-abetting liability was available under both the ATS and the TVPA. Other circuits had split on whether the ATS provides jurisdiction for aiding-and-abetting liability. The Trump administration filed &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/DocketPDF/24/24-856/397322/20260225165613681_24-856tsacUnitedStates.pdf" target="_blank"&gt;an amicus brief&lt;/a&gt; in the Supreme Court urging dismissal of the suit against Cisco. &lt;/p&gt;
&lt;h2&gt;Ruling&lt;/h2&gt;
&lt;p&gt;The Supreme Court reversed the Ninth Circuit&amp;rsquo;s decision. Writing for the 6-3 majority on the ATS issue, Justice Barrett concluded that courts may not create new causes of action under the ATS. The Court&amp;rsquo;s reasoning rested on separation-of-powers principles and foreign-policy concerns.&lt;/p&gt;
&lt;p&gt;ATS cases, Justice Barrett explained, &amp;ldquo;by their nature&amp;rdquo; implicate foreign policy, even when brought only against U.S. defendants. Such claims almost invariably require courts to examine allegations of serious misconduct by foreign governments and foreign officials abroad. As the Court explained, recognizing new causes of action under the ATS &amp;ldquo;would intrude on both Congress&amp;rsquo; prerogative to provide rights of action and the power of the political branches to direct the Nation&amp;rsquo;s foreign policy.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Second, and consistent with the Court&amp;rsquo;s recent skepticism toward implied causes of action generally, the Court emphasized that creating causes of action is a task for Congress, not the judiciary. In light of the foreign-policy implications of ATS litigation, the Court reasoned that there will always be a &amp;ldquo;sound reason&amp;rdquo; &lt;em&gt;not&lt;/em&gt; to recognize an implied cause of action and to defer to Congress in the face of congressional silence in the ATS context. The Court also pointed to the TVPA as evidence that Congress knows how to create express causes of action for certain international human rights violations (i.e., torture and extrajudicial killing) when it chooses to do so.&lt;/p&gt;
&lt;p&gt;The Court separately held (8-to-1) that the TVPA does not impose liability for aiding and abetting a primary violation of the statute. The TVPA creates a cause of action against an individual who, under color of foreign law, &amp;ldquo;subjects&amp;rdquo; another to torture or extrajudicial killing. The Court concluded that the TVPA&amp;rsquo;s use of the word &amp;ldquo;subjects&amp;rdquo; was not enough to create secondary liability.&lt;/p&gt;
&lt;p&gt;Justice Jackson, joined by Justice Kagan, agreed with the TVPA holding but not all of the majority&amp;rsquo;s reasoning. Justice Sotomayor dissented, arguing that the Court has effectively overruled &lt;em&gt;Sosa&lt;/em&gt; (without directly saying so) and improperly foreclosed claims alleging serious violations of international law.&lt;/p&gt;
&lt;h2&gt;Implications&lt;/h2&gt;
&lt;p&gt;After &lt;em&gt;Cisco&lt;/em&gt;, the ATS is no longer available for plaintiffs to bring claims under modern international human rights norms in U.S. courts. Indeed, the effects of &lt;em&gt;Cisco&lt;/em&gt; are already being felt. In &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.ca4.uscourts.gov/opinions/251043.P.pdf" target="_blank"&gt;Al Shimari v. CACI Premier Technology Inc.&lt;/a&gt;&lt;/em&gt;, the defendant has &lt;a rel="noopener noreferrer" href="https://news.bloomberglaw.com/federal-contracting/caci-says-high-court-ruling-requires-tossing-abu-ghraib-verdict" target="_blank"&gt;asked&lt;/a&gt; the Fourth Circuit to revisit a $42 million jury verdict arising from alleged abuses at Abu Ghraib prison in Iraq, arguing that &lt;em&gt;Cisco&lt;/em&gt; bars the plaintiffs&amp;rsquo; ATS conspiracy and aiding-and-abetting theories. &lt;/p&gt;
&lt;p&gt;For U.S. companies, &lt;em&gt;Cisco&lt;/em&gt; ends two decades of exposure to ATS claims premised on violations of international human rights law abroad. Previously, in &lt;em&gt;Mohamad v. Palestinian Authority&lt;/em&gt;, the Supreme Court held that corporations may not be sued under the TVPA (which extends liability only to an &amp;ldquo;individual&amp;rdquo;). &lt;em&gt;Mohamad&lt;/em&gt; and &lt;em&gt;Cisco&lt;/em&gt; thus significantly narrow the federal causes of action plaintiffs have used to bring international human rights claims in the United States. &lt;em&gt;Cisco&lt;/em&gt;, however, does not eliminate all potential human-rights-related litigation risks in U.S. courts. First, the decision did not disturb the narrow historical international law norms recognized in &lt;em&gt;Sosa&lt;/em&gt; &amp;mdash; assaults on ambassadors, violations of safe conduct, and piracy &amp;mdash; although those norms have played a minimal role in modern human rights litigation. Second, plaintiffs may still bring direct liability claims under the TVPA against individual defendants for torture or extrajudicial killing or against individuals or corporations under the TVPRA, the ATA, or other federal and state-law theories where available. For example, as we mentioned in our &lt;a href="/en/perspectives/advisories/2025/02/anti-terrorism-act-suits-against-foreign-states"&gt;ATA Advisory&lt;/a&gt;, there is a growing trend in federal courts to expand the pool of potential defendants and the scope of liability under the ATA. Plaintiffs may also seek remedies in foreign courts or pursue non-litigation strategies, including regulatory complaints, sanctions requests, export-control referrals, and public pressure campaigns.&lt;/p&gt;
&lt;p&gt;Companies seeking guidance on these issues should contact the authors of this Advisory or their usual Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7CE874CB-CDAF-495A-9EC7-5BEC1819B2E6}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/reassessing-cmmc</link><a10:author><a10:name>Thomas A. Pettit</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pettit-thomas</a10:uri><a10:email>thomas.pettit@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><title>Reassessing CMMC: DOD Suspends CMMC Phase II, But Core DFARS Obligations Endure</title><description>The U.S. Department of Defense has temporarily suspended implementation of Cybersecurity Maturity Model Certification (CMMC) Phase II while it conducts a 60-day review of the program, citing concerns over high compliance costs, limited third-party assessment capacity, and impacts on the defense industrial base. Although third-party certification requirements are on hold, defense contractors must continue to comply with existing cybersecurity obligations &amp;mdash; including NIST SP 800-171, DFARS safeguarding and reporting requirements, and CMMC Level 1 and Level 2 self-assessments &amp;mdash; while monitoring potential reforms and upcoming guidance.</description><pubDate>Tue, 14 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On July 13, 2026, the U.S. Department of Defenser (DOD) &lt;a rel="noopener noreferrer" href="https://federalnewsnetwork.com/wp-content/uploads/2026/07/CIO-CMMC-Reform-Memo_26-P-1023.pdf" target="_blank"&gt;temporarily suspended&lt;/a&gt; Cybersecurity Maturity Model Certification (CMMC) Phase II requirements &amp;mdash; originally scheduled to take effect on November 10, 2026 &amp;mdash; pending a review by the CMMC Reform Task Force. (Our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/09/cmmc-final-rule-key-takeaways-for-defense-contractors" target="_self"&gt;September 2025 Advisory&lt;/a&gt; detailed the CMMC phases and other CMMC program requirements.) DOD suspended CMMC Phase II due to concerns about &amp;ldquo;prohibitive compliance costs, severe shortages in third-party assessment capacity, and complex regulatory timelines&amp;rdquo; as well as reports from the Small Business Administration indicating &amp;ldquo;that the current CMMC program is structurally incompatible with our need to rapidly expand the DIB [Defense Industrial Base].&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Pursuant to the DOD memorandum:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The CMMC Phase II transition is suspended, and &amp;ldquo;all pending and future CMMC implementation milestones across DoW solicitations and contracts are held in abeyance until further notice.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;Although the CMMC Defense Federal Acquisition Regulation Supplement (DFARS) Program Rule gave DOD discretion to require CMMC Level 2 C3PAO certification assessments during Phase I, the memorandum instructs that &amp;ldquo;Program Managers and requiring activities shall only include the need for CMMC Level 1 or Level 2 Self Assessments in procurement request and requirement documents.&amp;rdquo; &lt;a rel="noopener noreferrer" href="https://dodcio.defense.gov/Portals/0/Documents/Library/ImplementingSuspensionCMMC-PhaseII.pdf" target="_blank"&gt;DOD guidance&lt;/a&gt; makes clear that &amp;ldquo;Program Managers and requiring activities may &lt;strong&gt;not&lt;/strong&gt; designate CMMC Level 2 (C3PAO) or Level 3 (DIBCAC) assessments during this period.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;DOD is establishing the CMMC Reform Task Force &amp;ldquo;to conduct a top-to-bottom 60-day review of the certification program.&amp;rdquo; The Task Force will &amp;ldquo;provide recommendations for a reformed cybersecurity and operational resilience framework that prioritizes speed to capability, lowers barriers for small, medium, and non-traditional businesses, and replaces prohibitive third-party compliance models with scalable, realistic security measures.&amp;rdquo;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;DOD&amp;rsquo;s decision to temporarily suspend CMMC Phase II does not affect DOD contractors&amp;rsquo; foundational cybersecurity obligations. The information safeguarding requirements in DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting, remain in effect as do the CMMC Level 1 and Level 2 self-assessment Phase I requirements in DFARS 252.204-7021. Thus, DOD contractors must continue to comply with National Institute of Standards and Technology Special Publication 800-171 Rev 2 and cloud security requirements, cyber incident reporting obligations, and other directives. DOD will also continue its efforts to &amp;ldquo;enforce cybersecurity compliance with the NIST SP 800-171 Rev 2 standard through self-assessments and select government-led assessments, focusing on tangible cyber hygiene.&amp;rdquo;&lt;/p&gt;
&lt;h2&gt;What&amp;rsquo;s Next&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;DOD will collect information through a &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsam.gov%2Fworkspace%2Fcontract%2Fopp%2F89ef9bfb0834473791e991c712698d94%2Fview&amp;amp;data=05%7C02%7CTheresa.Denson%40arnoldporter.com%7C0393ae2f05164150a70f08dee1cce1ff%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639196467286744322%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=A0yODMq8VbyaPDtIp6G8kdooGRprJ0o88rZUclYqwgM%3D&amp;amp;reserved=0" target="_blank"&gt;Request for Information&lt;/a&gt; (RFI), and industry members interested in providing input can submit responses to the RFI by August 14, 2026.&lt;/li&gt;
    &lt;li&gt;For active solicitations that require CMMC Level 2 (C3PAO) or CMMC Level 3 status, DOD must issue amendments &amp;ldquo;explicitly removing those requirements.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;For active contracts that require CMMC Level 2 (C3PAO) or CMMC Level 3 status, DOD must modify the contracts to remove those requirements &amp;ldquo;prior to the exercise of the next option period or during the next scheduled administrative modification.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;DOD contractors should continue to exercise vigilance both in complying with existing DFARS requirements and in monitoring new proposed information security and supply chain requirements.&lt;/li&gt;
&lt;/ul&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C70D3714-EC11-4C83-B57D-05A779413E49}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-strengthens-ai-leadership-appoints-roger-maeda-as-the</link><title>Arnold &amp; Porter Strengthens AI Leadership, Appoints Roger Maeda as the Firm’s First Chief Artificial Intelligence Officer</title><description>&lt;strong&gt;WASHINGTON, D.C., July 13,&amp;nbsp; 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter is pleased to announce the appointment of Roger Maeda as the firm&amp;rsquo;s first Chief Artificial Intelligence Officer, reinforcing its commitment to responsible and innovative artificial intelligence and the future of technology-enabled legal services.&amp;nbsp;</description><pubDate>Mon, 13 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;WASHINGTON, D.C., July 13,  2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter is pleased to announce the appointment of Roger Maeda as the firm&amp;rsquo;s first Chief Artificial Intelligence Officer, reinforcing its commitment to responsible and innovative artificial intelligence and the future of technology-enabled legal services. Roger previously served as Director of Enterprise Applications and Application Development, leading the firm&amp;rsquo;s enterprise application strategy and software development initiatives. As AI continues to reshape the legal industry, Arnold &amp;amp; Porter is strengthening its leadership to guide the firm&amp;rsquo;s AI strategy and ensure it remains at the forefront of responsible AI adoption. &lt;/p&gt;
&lt;p&gt;&amp;ldquo;The firm created this role because AI is reshaping how we deliver legal services, and that shift demands dedicated leadership at the highest level,&amp;rdquo; said Ellen Kaye Fleishhacker, Global Co-Chair of Arnold &amp;amp; Porter. &amp;ldquo;Roger brings a rare combination of deep technical knowledge and a clear understanding of how our lawyers and clients operate. He is the right person to help us put AI to work for our clients.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&amp;ldquo;AI is changing the way we work and the way we serve our clients, and it is evolving faster than any technology we&amp;rsquo;ve adopted before,&amp;rdquo; added Sean Howell, Chief Executive Officer of Arnold &amp;amp; Porter. &amp;ldquo;Creating the Chief AI Officer role reflects our commitment to investing in innovation, strengthening our capabilities, and ensuring Arnold &amp;amp; Porter remains at the forefront of exceptional client service.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Roger Maeda said, &amp;ldquo;AI presents tremendous opportunities to enhance how we work and serve our clients. My focus will be on translating emerging technologies into practical solutions that empower our lawyers and business professionals while maintaining the quality, security, and service our clients expect.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In his new role, Roger will lead the firm's dedicated AI team, partnering with senior leaders across innovation, technology, and business services to build, test, and deploy AI tools in support of client work.&lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{5242B356-581D-4D61-A149-53243E799DDB}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/ron-levine-talks-energy-dealmaking-with-law360</link><title>Ron Levine Talks Energy Dealmaking with Law360</title><description>Ron Levine, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance Group, was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;State Of 2026 Energy Dealmaking: Midyear Report,&amp;rdquo; speaking with the publication about the global and national developments that have shaped energy transactions so far this year.</description><pubDate>Mon, 13 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Ron Levine, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Corporate &amp;amp; Finance Group, was recently quoted in the &lt;em&gt;Law360 &lt;/em&gt;article, &amp;ldquo;State Of 2026 Energy Dealmaking: Midyear Report,&amp;rdquo; speaking with the publication about the global and national developments that have shaped energy transactions so far this year.&lt;/p&gt;
&lt;p&gt;Ron emphasized that the combination of factors at play could spark a phase of increased energy transactional activity, noting that elevated energy prices are a key driver.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;You&amp;rsquo;ve got all the elements of a top-down growth phase in energy financing and [mergers and acquisitions],&amp;rdquo; he said. &amp;ldquo;And you have an external environment that&amp;rsquo;s causing energy prices to be higher.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2488864/state-of-2026-energy-dealmaking-midyear-report"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{BB7F0A60-26FA-485F-A98B-C9D895C5C068}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/pallavi-mehta-wahi-comments-on-seattle-legal-market-in-law360</link><title>Pallavi Mehta Wahi Comments on Seattle Legal Market in Law360</title><description>Pallavi Mehta Wahi, Arnold &amp;amp; Porter Chair of Western U.S. Strategic Growth and head of the firm&amp;rsquo;s Seattle office, was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;New BigLaw Competition Is Changing The Seattle Market,&amp;rdquo; discussing the importance of Seattle in the U.S. legal market.</description><pubDate>Mon, 13 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Pallavi Mehta Wahi, Arnold &amp;amp; Porter Chair of Western U.S. Strategic Growth and head of the firm&amp;rsquo;s Seattle office, was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;New BigLaw Competition Is Changing The Seattle Market,&amp;rdquo; discussing the importance of Seattle in the U.S. legal market.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;The leading global companies in the innovation industries are right at the hub of everything going on in the world: life sciences, hospital brands, consumer brands, technology. These are the companies with sophisticated regulatory enforcement and compliance challenges,&amp;rdquo; Pallavi said. She emphasized that Seattle is a hub for clients in industries undergoing significant periods of innovation, which require adept counsel who understands their complex regulatory, litigation, and transactional needs.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter&amp;rsquo;s Seattle office opened with just three attorneys in July 2025. Since then, the team has steadily grown to more than 40 attorneys and staff. The firm&amp;rsquo;s office footprint also continues to grow, with Arnold &amp;amp; Porter planning to move to a larger space by the end of the year.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/pulse/articles/2497864/new-biglaw-competition-is-changing-the-seattle-market"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{04D4B598-3E61-4517-9547-A894DDD49D3C}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/fdic-proposes-substantial-overhaul-of-confidential-information-regulations</link><a10:author><a10:name>Robert C. Azarow</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/azarow-robert-c</a10:uri><a10:email>robert.azarow@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>David F. Freeman, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/freeman-david-f</a10:uri><a10:email>David.Freeman@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Amber A. Hay</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hay-amber-a</a10:uri><a10:email>amber.hay@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kevin M. Toomey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/toomey-kevin-m</a10:uri><a10:email>kevin.toomey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Paul Lim</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lim-paul</a10:uri><a10:email>paul.lim@arnoldporter.com</a10:email></a10:author><title>FDIC Proposes Substantial Overhaul of Confidential Information Regulations</title><description>The &lt;span&gt;Federal Deposit Insurance Corporation (&lt;/span&gt;FDIC) has proposed its first major update to its Confidential Supervisory Information (CSI) rules in nearly 30 years, with comments due by August 31, 2026. The proposal would reorganize the agency's disclosure regulations and, most notably, expand the circumstances under which FDIC-supervised institutions may share CSI without prior FDIC approval. If adopted, banks could disclose CSI for legitimate business purposes to a broader range of recipients &amp;mdash; including outside counsel, auditors, consultants, IT providers, certain executives, affiliates, and potential merger partners &amp;mdash; subject to confidentiality agreements and other conditions. The proposed changes are intended to modernize and clarify the FDIC's disclosure framework while providing institutions with greater operational flexibility.&amp;nbsp;Comments on the proposed rule are due by August 31, 2026</description><pubDate>Mon, 13 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The Federal Deposit Insurance Corporation (FDIC) has proposed its first major update to the rules governing Confidential Supervisory Information (CSI) in roughly three decades. The Notice of Proposed Rulemaking (Proposed Rule), which was published in the Federal Register on June 30, 2026, seeks to &amp;ldquo;update, clarify, and supplement&amp;rdquo; the rules regarding the disclosure of CSI by the FDIC and others.[[N:FDIC, Disclosure of Information, 91 Fed. Reg. 39,726 (June 30, 2026).]] Perhaps most significantly for FDIC-supervised institutions, the Proposed Rule would expand the ability of such institutions to disclose CSI, including to certain professional-services providers and potential merger partners, without the pre-approval of the FDIC under certain circumstances. Comments on the Proposed Rule, which includes 30 specific questions posed by the FDIC, are due by August 31, 2026.&lt;/p&gt;
&lt;h2&gt;Overview&lt;/h2&gt;
&lt;p&gt;The Proposed Rule would reorganize Part 309 of the FDIC&amp;rsquo;s regulations into four subparts and would relocate the service-of-process rules to a new Part 306. As revised, Part 309 would consist of the following:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;strong&gt;Subpart A (General)&lt;/strong&gt;: Providing a statement on the FDIC&amp;rsquo;s authority, the scope of the regulation, and definitions&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Subpart B (Freedom of Information Act)&lt;/strong&gt;: Detailing the process for submitting and responding to FOIA requests; intended to provide greater transparency into existing FDIC practices and to add a process for handling confidential commercial information&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Subpart C (Discretionary Disclosure of Confidential Information)&lt;/strong&gt;: Relaxing the FDIC&amp;rsquo;s current prohibition on disclosure of CSI to allow disclosure for &amp;ldquo;legitimate business purposes&amp;rdquo; in certain circumstances without FDIC pre-approval; for situations in which FDIC approval is still necessary, the agency&amp;rsquo;s &amp;ldquo;good cause&amp;rdquo; standard is clarified&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Subpart D (Disclosure of Confidential Information in Legal Proceedings in Which the FDIC is Not a Party)&lt;/strong&gt;: Clarifying the process for seeking disclosure of CSI in legal proceedings in which the FDIC is not a party&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;While all of the proposed changes have potentially significant ramifications for depository institutions and other interested parties, it is the revised Subpart C that likely will have the greatest day-to-day impact on FDIC-supervised banks.&lt;/p&gt;
&lt;h2&gt;Discretionary Disclosure&lt;/h2&gt;
&lt;p&gt;The Proposed Rule would allow insured depository institutions to disclose CSI to a number of enumerated parties, provided such disclosure was for &amp;ldquo;legitimate business purposes&amp;rdquo; and the recipient, excluding the institution&amp;rsquo;s (or its affiliate&amp;rsquo;s) own directors, officers, and employees, had entered into a written confidentiality agreement regarding the CSI. This change is a considerable expansion of the existing regulation, which contemplates disclosure only to the institution&amp;rsquo;s own personnel and majority holding companies without prior approval. As amended, recipients newly eligible to receive CSI without prior approval would include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Affiliates and their directors, officers, and employees&lt;/li&gt;
    &lt;li&gt;Outside legal counsel, accountants, and auditors&lt;/li&gt;
    &lt;li&gt;Greater than 50% shareholders (with a greatly streamlined process compared to the existing regulation)&lt;/li&gt;
    &lt;li&gt;&amp;ldquo;Qualifying Service Providers,&amp;rdquo; which would include consulting and IT providers, as well as providers of services used in delivering the institution&amp;rsquo;s financial products and services&lt;/li&gt;
    &lt;li&gt;An individual to whom an offer of employment as a &amp;ldquo;senior executive officer&amp;rdquo; (e.g., President, CEO, COO, CFO, CLO, CIO, etc.) has been made&lt;/li&gt;
    &lt;li&gt;Insured depository institutions (including their affiliates, legal counsel, and auditors) that are potential merger counterparties, up to three times every five years, provided the potential counterparty executes a waiver of any potential claims against the FDIC&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Holding companies (i.e., shareholders owning greater than 50% of the voting stock of the subsidiary bank) also remain on the list, albeit with more streamlined procedures. Beyond being eligible recipients, holding companies also would be permitted to disclose FDIC CSI lawfully in their possession to the same categories of recipients, and under the same conditions, as their subsidiary banks.&lt;/p&gt;
&lt;p&gt;Parties not on the pre-authorized list would still require FDIC approval under the agency&amp;rsquo;s clarified &amp;ldquo;good cause&amp;rdquo; standard, which would now include eight specific factors. In addition, institutions would generally be permitted to disclose CSI that is more than 25 years old, provided that other restrictions (e.g., privacy) would not prohibit disclosure and that the FDIC had not directed otherwise.&lt;/p&gt;
&lt;h2&gt;Takeaway&lt;/h2&gt;
&lt;p&gt;The Proposed Rule should come as a welcome development for FDIC-supervised institutions. While other prudential regulators have long permitted some of these disclosures, such as to auditors and counsel, the FDIC&amp;rsquo;s regulations, on their face, have always been much more restrictive. Interested parties should review the details of the new provisions, as well as the 30 specific questions posed by the FDIC, and determine whether to comment.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;*&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;If you would like to discuss the FDIC&amp;rsquo;s Proposed Rule or determine whether to comment, please contact any of the authors of this Advisory or your usual firm contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{66436526-C60E-41CC-8016-6A5B40B7948D}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/fda-proposes-new-registration-and-listing-pathway-for-distributed-manufacturing</link><a10:author><a10:name>Howard Sklamberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sklamberg-howard</a10:uri><a10:email>howard.sklamberg@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Elizabeth Trentacost</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trentacost-elizabeth</a10:uri><a10:email>elizabeth.trentacost@arnoldporter.com</a10:email></a10:author><title>FDA Proposes New Registration and Listing Pathway for Distributed Drug Manufacturing and Aligns Foreign Establishment Obligations With Current Law</title><description>On July 13, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would amend the drug establishment registration and drug listing requirements for establishments engaged in distributed manufacturing (DM) and for foreign drug establishments.</description><pubDate>Mon, 13 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On July 13, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would amend the drug establishment registration and drug listing requirements for establishments engaged in distributed manufacturing (DM) and for foreign drug establishments.[[N: &lt;a rel="noopener noreferrer" href="https://www.govinfo.gov/content/pkg/FR-2026-07-13/pdf/2026-14073.pdf" target="_blank"&gt;Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments&lt;/a&gt;, 91 Fed. Reg. 42888 (July 13, 2026).]] First, it would create a DM-specific registration pathway for distributed manufacturing establishments (DMEs) that meet select criteria. Second, it proposes updates to the drug establishment registration and drug listing requirements to incorporate clarifying changes made to the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act) in 2022 through section 2511 of the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). These proposals are among a group of policy efforts that FDA has taken to support and strengthen domestic drug manufacturing. The agency hopes that the efforts will improve supply chain visibility and asserts that these changes will provide a clearer, more accurate picture of where and how drugs are made while making it easier for innovative manufacturers to operate efficiently.[[N: &lt;a rel="noopener noreferrer" href="https://www.fda.gov/industry/fda-actions-support-and-strengthen-domestic-drug-manufacturing" target="_blank"&gt;FDA Actions to Support and Strengthen Domestic Drug Manufacturing&lt;/a&gt; (July 10, 2026).]]&lt;/p&gt;
&lt;p&gt;Below, we summarize the key provisions, highlight notable changes relative to current requirements, and flag the issues of greatest interest to manufacturers and industry stakeholders.&lt;/p&gt;
&lt;h2&gt;Distributed Manufacturing Proposal&lt;/h2&gt;
&lt;h3&gt;Overview&lt;/h3&gt;
&lt;p&gt;Distributed manufacturing (DM) is a decentralized manufacturing strategy that uses advanced manufacturing technology. It provides an alternative to traditional manufacturing and is expected to be used when an agile approach to manufacturing is necessary or beneficial to meet patient needs for medicines, and when meeting such needs is either not possible or not ideal through traditional manufacturing. The DM provisions, which are issued in part, under the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative, apply to &amp;ldquo;distributed manufacturing establishments&amp;rdquo; (DMEs). &lt;/p&gt;
&lt;p&gt;The concept of a DME is based on a hub-and-spoke model &amp;mdash; the DM hub and the DM unit &amp;mdash; and eligibility for treatment as a DME requires meeting numerous stringent criteria, covered below. A graphical depiction of the hub and spoke model that underlies FDA&amp;rsquo;s proposal is below:&lt;/p&gt;
&lt;p&gt;&lt;img alt="Infographic illustrating a Distributed Manufacturing Establishment (DME) hub-and-spoke model, showing a centralized quality unit overseeing multiple distributed manufacturing units through a unified pharmaceutical quality system for scalable drug manufacturing." src="/-/media/images/advisory-assets/2026/07/distributed-manufacturing-establishment.png?rev=63a06707ccd44523995a48181e410ab0&amp;amp;hash=30A1B0A09DFE21DB52E1FE8BC93FF6AD" width="1000" height="666.9" /&gt;&lt;/p&gt;
&lt;p&gt;Under the proposal, the DME could register as a single drug manufacturing establishment, even where the DMUs are located in geographically disparate areas. Currently, each DMU and the DM hub[[N: A DM hub is the business at one physical location that serves as the primary location of the quality unit responsible for implementing the unified pharmaceutical quality system to direct, monitor, and control the manufacture of drugs to ensure product quality at the DME, including ensuring that all DMUs within the DME at any location are and remain equivalent in design and operation. 91 Fed. Reg. at 42903.]] (if it engages in manufacturing) would be required to register as separate establishments, even where they operate collectively as one establishment. &lt;/p&gt;
&lt;h3&gt;DME Criteria&lt;/h3&gt;
&lt;p&gt;A DME comprises a DM hub and one or more DMUs that meet the following criteria:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The DMUs are demonstrated to be and remain equivalent in design and operation at any location.&lt;/li&gt;
    &lt;li&gt;The DMUs engage in the manufacture, preparation, propagation, compounding, or processing of the &lt;strong&gt;same drug(s)&lt;/strong&gt; at one or more physical location(s), under the oversight and control of a single quality unit, which has a management structure located at the DM hub and has implemented a unified pharmaceutical quality system (UPQS).&lt;/li&gt;
    &lt;li&gt;Collectively, the hub and DMUs &amp;mdash;
    &lt;ul&gt;
        &lt;li&gt;&amp;nbsp;(a) Operate under one management pursuant to a manufacturing strategy designed to be decentralized&lt;/li&gt;
        &lt;li&gt;(b) Were subject to a preapproval inspection in connection with an approved marketing application that describes the use of a decentralized manufacturing strategy for at least one drug of each profile class[[N: Profile class &amp;ldquo;refers to the categorization of different processing conditions and product types. Immediate-release, delayed-release, and extended-release solid oral dosage forms would be different profile classes of drugs.&amp;rdquo; 91 Fed. Reg. 42894.]] manufactured by the distributed manufacturing establishment and is an approved 505(b)(1) or 505(b)(2) NDA, ANDA, new animal drug application (NADA) (or abbreviated applications), or an original biologic license application or biosimilar (i.e., a 351(a) or 351(k) BLA)&lt;/li&gt;
    &lt;/ul&gt;
    &lt;/li&gt;
    &lt;li&gt;At least one DMU is capable of moving or being moved to another physical location or there are at least two DMUs in the DME if none can be moved.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;FDA&amp;rsquo;s proposal would allow DMEs to manufacture certain products that lack an approved application (such as over-the-counter monograph drugs), provided that each non-application product is the same profile class as one or more drugs manufactured by the DME for an approved application that describes the use of a decentralized manufacturing strategy.&lt;/p&gt;
&lt;p&gt;This definition does not permit arrangements where different contract manufacturing organizations are hired to operate a DMU to manufacture the same drug(s) at multiple locations, largely due to potentially differing and competing quality systems which frustrate the ability to ensure that equivalence in design and operations is maintained across the DMUs. Nor are relabelers, repackers, or salvagers that are third parties to the applicant and the manufacturer and do not operate under the ownership or control of the manufacturer eligible for consideration as a DME &amp;mdash; they fail to meet the requirement of having the requisite UPQS.&lt;/p&gt;
&lt;h3&gt;Mechanics&lt;/h3&gt;
&lt;p&gt;In terms of who must register, how, and when, FDA adapted 21 CFR Part 207 to include DM-specific provisions. For example, proposed sec. 207.17(b) creates a separate registration requirement for DMEs that is similar to the general requirement for establishments in 207.17(a). DM-specific timing requirements for registration are also provided, which are tailored to the hub-and-spoke model of a DME (e.g., registration of a DME no later than five calendar days after the first domestic DMU begins to manufacture a drug for commercial distribution, or before a drug manufactured at any foreign DMU is imported or offered for import into the United States, whichever of the two occurs first). For the information required for registration, the proposal would require similar information in scope to the information currently required for establishment registration, but with differences accounting for the hub-and-spoke model for a DME. For example, FDA proposes assigning the UFI and FDA Establishment Identifier (FEI) to the DM hub and is proposing to require a unique identifier for each DMU (e.g., a sub-FEI number). &lt;/p&gt;
&lt;p&gt;FDA notes that an establishment registered as a DME that does not meet the DME requirements (or falls out of compliance such as by a DMU failing to remain equivalent in design and operation to other DMUs in the DME and the registrant does not bring the DMU into equivalence) would not be &amp;ldquo;duly&amp;rdquo; registered and drugs manufactured at the establishment would be deemed to be misbranded. Note, FDA intends to provide additional details on complying with cGMPs in an FDA guidance on cGMP considerations for DM that will &amp;ldquo;assist manufacturers in addressing the complexities associated with DM when complying with FDA&amp;rsquo;s cGMP requirements (e.g., equivalency, control procedures implemented under a UPQS, and mobile units).&amp;rdquo;[[N: 91 Fed. Reg. 42894.]]&lt;/p&gt;
&lt;h3&gt;Impact&lt;/h3&gt;
&lt;p&gt;FDA touts the proposed DME registration requirements as benefitting industry, the government, and patients by &amp;ldquo;increas[ing] visibility into the drug supply chain, as the co-registration of DME hub and spokes would enable FDA to correctly map out each DM configuration and understand the relationships between all components, supporting FDA's efforts to prevent and mitigate drug shortages and respond to unsafe products.&amp;rdquo;[[N: 91 Fed. Reg. at 42899.]]&lt;/p&gt;
&lt;p&gt;Presently, DM is not widespread and FDA concedes it &amp;ldquo;remains uncertain as to the likely prevalence of distributed manufacturing in the coming years.&amp;rdquo;[[N: 91 Fed. Reg. at 42901.]] Its estimated burden for Paperwork Reduction Act of 1995 (PRA) and Preliminary Regulatory Impact Analysis (PRIA) purposes reflects that: FDA assumes zero to two new DMEs in the three years after publication of the final rule, and in subsequent years, FDA projects increased interest with three to five new DMEs in years 4-6 and eight to ten new DMEs in years 7-10.&lt;/p&gt;
&lt;h2&gt;Foreign Establishment Proposal&lt;/h2&gt;
&lt;p&gt;The proposed rule is intended to &amp;ldquo;eliminate any perceived inconsistencies&amp;rdquo; between section 510 of the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act) and FDA regulations in 21 CFR Part 207. Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act), as amended by the PREVENT Pandemics Act, requires every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States to register its establishment with FDA and list such drugs. Such requirements apply regardless of whether the drug undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States before being imported or offered for import in the United States. &lt;/p&gt;
&lt;p&gt;The amendments would make clarifying changes to FDA&amp;rsquo;s regulations by expressly requiring establishment registration and product listing for foreign establishments that manufacture, repack, relabel, or salvage a drug that is imported or offered for import into the United States &lt;em&gt;regardless of whether the drug undergoes further manufacture, preparation, propagation, compounding, or processing at a separate foreign establishment before being imported or offered for import into the United States&lt;/em&gt;. The current regulations at 21 CFR 207.17(a) do not include this italicized phrase. In addition, FDA stated in the 2016 Registration and Listing Final Regulatory Impact Analysis (FRIA)[[N: &lt;a rel="noopener noreferrer" href="https://www.fda.gov/media/100022/download" target="_blank"&gt;Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis&lt;/a&gt; (Aug. 2016).]] that a foreign API manufacturer that only distributes an API outside of the United States is not required to register even if the finished product manufactured from the API is eventually imported into the United States. These present differences between the statute and the regulations and FDA&amp;rsquo;s statement could result in confusion about who must register and list &amp;mdash; even though it is currently FDA&amp;rsquo;s position that establishments must register and list if their product undergoes further manufacture, preparation, propagation, compounding, or processing at a separate foreign establishment before being imported or offered for import into the United States because of the self-implementing requirement of section 510 of the FD&amp;amp;C Act. &lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s approach is consistent with its perspective on severability. FDA&amp;rsquo;s stance is that the foreign establishment and drug listing requirements are severable from the DM proposal such that if the rule is finalized and a court determines one or more of the DM provisions to be invalid, that partial invalidation should not render as invalid any of the foreign establishment registration and drug listing provisions. FDA also takes the position that each of the proposed foreign establishment registration and listing provisions may operate independently from one another, and if the application of any portion of such provisions of this rule is determined to be invalid with respect to a particular circumstance, the agency intends that such provisions would remain applicable to all other circumstances.[[N: 91 Fed. Reg. at 42898.]]&lt;/p&gt;
&lt;p&gt;Through these amendments, FDA seeks greater visibility into the drug supply chain, anticipates that unregistered foreign firms will more clearly understand their drug establishment registration and product listing obligations, and anticipates increased compliance among covered foreign establishments. FDA also notes that this allows equal application of the registration and listing requirements for foreign and domestic establishments. The practical impact is that, through increased establishment registration and product listing, FDA can exercise more oversight of the drug supply chain. Establishment registration is the primary way for FDA to identify drug manufacturers and is the primary source used to include establishments in FDA&amp;rsquo;s establishment site selection model that determines routine inspection priority. &lt;/p&gt;
&lt;p&gt;The anticipated impact of the foreign establishment registration and listing provisions on industry is higher than for DMEs and is expected to have a greater impact on over-the-counter (OTC) manufacturers. FDA estimates that the proposal will cover about 25 foreign establishments that manufacture a drug subject to an approved application and about 1,600 establishments that manufacture an OTC monograph drug, for a total estimate of 1,313 respondents submitting an initial foreign establishment registration for 1,625 currently unregistered foreign manufacturing establishments. FDA further estimates that these foreign establishments will submit 550 listings for approved products and 24,000 for OTC monograph drugs. &lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;Please contact one of the authors of this Advisory or your regular Arnold &amp;amp; Porter contact if you are interested in discussing the proposed rule or its impact. Comments on the proposed rule are due by September 11, 2026.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1B487AB6-5C8A-478F-8DAE-E34781339621}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/puget-sound-business-journal-interviews-pallavi-mehta-wahi-on-arnold-porter-seattle-growth</link><title>Puget Sound Business Journal Interviews Pallavi Mehta Wahi on Arnold &amp; Porter Seattle Growth</title><description>Pallavi Mehta Wahi, Arnold &amp;amp; Porter Chair of Western U.S. Strategic Growth and head of the firm&amp;rsquo;s Seattle office and India practice, was recently quoted in the &lt;em&gt;Puget Sound Business Journal&lt;/em&gt; article, &amp;ldquo;Law firm Arnold &amp;amp; Porter to expand with move to Seattle&amp;rsquo;s One Union Square,&amp;rdquo; discussing the firm&amp;rsquo;s ongoing strategic West Coast growth.</description><pubDate>Fri, 10 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Pallavi Mehta Wahi, Arnold &amp;amp; Porter Chair of Western U.S. Strategic Growth and head of the firm&amp;rsquo;s Seattle office and India practice, was recently quoted in the &lt;em&gt;Puget Sound Business Journal&lt;/em&gt; article, &amp;ldquo;Law firm Arnold &amp;amp; Porter to expand with move to Seattle&amp;rsquo;s One Union Square,&amp;rdquo; discussing the firm&amp;rsquo;s ongoing strategic West Coast growth.&lt;/p&gt;
&lt;p&gt;Since the firm&amp;rsquo;s Seattle office opened with just three attorneys in July 2025, the team has steadily grown to more than 40 attorneys and staff. The publication described it as having nearly doubled in size since its last office opening. &amp;ldquo;Arnold &amp;amp; Porter&amp;rsquo;s Seattle office at U.S. Bank Center launched with 25 employees,&amp;rdquo; PSBJ wrote. &amp;ldquo;It currently has 41 attorneys and staff.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The article also noted that, after establishing &amp;ldquo;its first Seattle office with a 15,000-square-foot lease, [which] has since expanded to 25,000 square feet,&amp;rdquo; Arnold &amp;amp; Porter now &amp;ldquo;plans to move to the 39,000-square-foot space by the end of the year.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In an interview, Pallavi highlighted the wide range of expanding practices, noting that the Seattle office has seen &amp;ldquo;across-the-board&amp;rdquo; growth, including in industries such as technology, life sciences, healthcare, manufacturing, and real estate.&lt;/p&gt;
&lt;p&gt;She also discussed the importance of the firm operating where its clients are doing business, including in downtown Seattle.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;We are Seattle residents, and we are business owners in the city, and we really want to support the growth, resurgence, and invigoration of the downtown corridor,&amp;rdquo; Pallavi said. &amp;ldquo;We want to be where our clients are.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://bizj.us/1qqbko" target="_blank"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{45E82BB2-C6E4-4854-BDCC-2A0FBFA6C0BE}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/attempt-to-amend-in-the-first-upf-personal-injury-suit-fails</link><a10:author><a10:name>Anand Agneshwar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/agneshwar-anand</a10:uri><a10:email>anand.agneshwar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Paige Hester Sharpe</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sharpe-paige-hester</a10:uri><a10:email>paige.sharpe@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lori B. Leskin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/leskin-lori-b</a10:uri><a10:email>lori.leskin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brandon W. Neuschafer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/neuschafer-brandon-w</a10:uri><a10:email>brandon.neuschafer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lauren S. Wulfe</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wulfe-lauren-s</a10:uri><a10:email>lauren.wulfe@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lindsay Strong</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/strong-lindsay</a10:uri><a10:email>lindsay.strong@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nina Leviten</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/leviten-nina</a10:uri><a10:email>nina.leviten@arnoldporter.com</a10:email></a10:author><title>Attempt to Amend in the First UPF Personal Injury Suit Fails to Clear Specific Causation Hurdle</title><description>On June 30, 2026, the U.S. District Court for the Eastern District of Pennsylvania denied the plaintiff leave to amend his complaint in &lt;em&gt;Martinez v. Kraft Heinz&lt;/em&gt;, reinforcing that private ultra-processed food (UPF) personal injury claims must plausibly allege product-specific but-for causation. The court held that generalized allegations linking UPFs to disease and industry-wide liability theories were insufficient to state a claim, underscoring the significant causation hurdles facing private plaintiffs while leaving the litigation landscape for government enforcement actions largely unchanged.</description><pubDate>Fri, 10 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 30, 2026, Judge Mia Roberts Perez of the U.S. District Court for the Eastern District of Pennsylvania denied plaintiff Bryce Martinez&amp;rsquo;s motion for leave to amend his complaint against 11 major food companies, holding that his proposed First Amended Complaint (FAC) failed to cure the primary defect with his original pleading: the failure to plausibly plead a causal link between any defendant&amp;rsquo;s ultra-processed foods (UPFs) and his alleged injuries.[[N:Mem. Op., &lt;em&gt;Martinez v. Kraft Heinz Co., et al.&lt;/em&gt;, No. 2:25-cv-00377-MRP (E.D. Pa. June 30, 2026), ECF No. 162.]] The ruling is the second dismissal in the first personal injury suit targeting UPFs, and it sharpens the pleading bar that plaintiffs will need to clear in other pending and future UPF product liability litigation.&lt;/p&gt;
&lt;p&gt;As we discussed in a &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/12/the-latest-litigation-threat-targeting-upfs" target="_self"&gt;prior Advisory&lt;/a&gt;, government-brought cases pose a far greater risk to food companies than personal injury cases such as &lt;em&gt;Martinez&lt;/em&gt;, in part because government plaintiffs need not show specific causation. The latest ruling confirms that, at least for now, the specific causation requirement remains the central obstacle for private UPF plaintiffs.&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;Martinez&lt;/em&gt;: Round Two&lt;/h2&gt;
&lt;p&gt;The court dismissed Martinez&amp;rsquo;s original complaint in August 2025 for failing to identify the specific products he consumed, when and how he consumed them, and how that consumption caused his type 2 diabetes and non-alcoholic fatty liver disease diagnoses at age 16. The court described the pleading as a &amp;ldquo;shotgun approach&amp;rdquo; that left defendants unable to determine &amp;ldquo;who is responsible for what.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Martinez moved for leave to amend in September 2025, attaching a proposed amended complaint that named 179 specific products that the eleven defendants manufacture, and alleged consumption frequencies and product-specific harmful ingredients for each. The defendants opposed the amendment based on undue delay and futility grounds. The court ruled that the amendment would be futile.&lt;/p&gt;
&lt;h2&gt;The Court&amp;rsquo;s Analysis&lt;/h2&gt;
&lt;h3&gt;The FAC Did Not Plead Specific, But-For Causation&lt;/h3&gt;
&lt;p&gt;The court held that allegations of &amp;ldquo;increased risk,&amp;rdquo; &amp;ldquo;biological plausibility,&amp;rdquo; and ingredient-disease &amp;ldquo;association&amp;rdquo; could not establish that any particular product, or any particular defendant&amp;rsquo;s product, actually caused Martinez&amp;rsquo;s injuries. Applying the but-for framework under U.S. Supreme Court precedent,[[N:&lt;em&gt;Bostock v. Clayton Cty.&lt;/em&gt;, 590 U.S. 644, 656 (2020).]] the court concluded that the plaintiff did not &amp;mdash; and likely could not &amp;mdash; allege that eliminating any one defendant or product from the FAC would have changed Martinez&amp;rsquo;s alleged diagnoses &amp;mdash; a result that defeated causation. The court also held that Martinez&amp;rsquo;s allegations connecting the rise of pediatric type 2 diabetes and nonalcoholic fatty liver disease with the rise of the UPF industry since the 1980s showed correlation, not causation, and that correlation alone cannot satisfy Pennsylvania&amp;rsquo;s causation requirement. The court further rejected Martinez&amp;rsquo;s reliance on an unpublished opinion in infant formula litigation,[[N:&lt;em&gt;Gray v. Abbott Labs.&lt;/em&gt;, No. 10 cv 6377, 2011 WL 3022274 (N.D. Ill. July 22, 2011).]] where a single recalled, contaminated product caused an infant&amp;rsquo;s illness almost immediately after consumption, distinguishing those facts from Martinez&amp;rsquo;s 12-year, 179-product, multi-manufacturer consumption history.&lt;/p&gt;
&lt;h3&gt;Alternative Liability and Market Share Liability Do Not Fill the Gap&lt;/h3&gt;
&lt;p&gt;The court also rejected Martinez&amp;rsquo;s theories of industry-wide liability under both the alternative liability and the market share liability doctrines. Martinez&amp;rsquo;s alternative liability failed for two reasons. First, the seminal case of &lt;em&gt;Summers v. Tice&lt;/em&gt;[[N:&lt;em&gt;Summers v. Tice&lt;/em&gt;, 199 P.2d 1, 1-2 (Cal. 1948).]] and its Pennsylvania progeny apply where only one of a known group of tortfeasors acting identically indisputably causes a single, identifiable harm. The court found this setting readily distinguishable in this litigation, given the cumulative, decade-plus nature of Martinez&amp;rsquo;s alleged injuries. Second, under Pennsylvania law,[[N:&lt;em&gt;Erlich v. Abbott Labs.&lt;/em&gt;, 5 Phila. 249, 251 (Phila. Ct. Com. Pls. 1981).]] alternative liability requires, among other things, that all defendants&amp;rsquo; products are identical and share the same defective qualities &amp;mdash; a requirement Martinez&amp;rsquo;s own pleading undercut by identifying different allegedly harmful additives in different products. Market share liability, established by a 1980 California Supreme Court case,[[N:&lt;em&gt;Sindell v. Abbott Labs.&lt;/em&gt;, 607 P.2d 924, 937 (Cal. 1980).]] failed for the same reason: UPFs, as pleaded, are not fungible or chemically identical across manufacturers, and Martinez did not plead that defendants collectively hold a substantial share of the UPF market.&lt;/p&gt;
&lt;h2&gt;Takeaways for UPF Defendants&lt;/h2&gt;
&lt;p&gt;&lt;strong&gt;First&lt;/strong&gt;, the specific-causation bar remains a durable defense in personal injury UPF litigation and likely beyond. Even Martinez&amp;rsquo;s markedly more detailed FAC, which named 179 products and alleged consumption frequencies and allegedly harmful ingredients for each, could not overcome the fundamental problem that generalized &amp;ldquo;increased risk&amp;rdquo; language cannot substitute for a plausible, product-specific causal chain. Defendants facing similar multi-product UPF claims should continue to press this deficiency early, including on any renewed motion to dismiss following an amendment.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Second&lt;/strong&gt;, courts remain reluctant to relax causation standards through industry-wide liability theories absent true product interchangeability. The court&amp;rsquo;s product-by-product analysis of differing additives and risk profiles is a useful roadmap for defendants confronting alternative liability or market share arguments in other UPF or multi-defendant product liability contexts.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Third&lt;/strong&gt;, this ruling does not diminish the threat posed by government-actor litigation like &lt;em&gt;California v. Kraft Heinz Co.&lt;/em&gt;[[N:Case No. CGC-25-631189 (Cal Super. Ct. Dec. 2, 2025).]] As discussed in our prior Advisory, government plaintiffs proceeding under consumer protection statutes can often rely on general causation and reasonable-consumer deception theories. The dismissal of &lt;em&gt;Martinez&lt;/em&gt; may, if anything, increase the relative attractiveness of the government-enforcement path for plaintiffs&amp;rsquo; counsel. &lt;em&gt;California v. Kraft Heinz Co.&lt;/em&gt; does not yet have a briefing schedule for any pleadings challenges, and it is still too early to tell if government-plaintiff cases will face similar hurdles. &lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Finally&lt;/strong&gt;, it remains to be seen how the specific-causation argument will fare in cases alleging fewer products or in other jurisdictions, including in the seven other personal injury UPF cases currently pending.[[N:See &lt;em&gt;Muthusami v. Kraft Heinz, et al.&lt;/em&gt;, No. 6:26-cv-00113 (M.D. Fla.); &lt;em&gt;Lawton v. Kraft Heinz, et al.&lt;/em&gt;, No. 26-cv-00044 (S.D. Miss.); &lt;em&gt;Sanford v. Kraft Heinz, et al.&lt;/em&gt;, No. 7:26-cv-01430 (S.D.N.Y.); &lt;em&gt;Ford v. Kraft Heinz, et al.&lt;/em&gt;, No. 3:26-cv-00077 (E.D. Ark.); &lt;em&gt;Kreie v. Kraft Heinz, et al.&lt;/em&gt;, No. 1:26-cv-738 (E.D. Wis.); &lt;em&gt;Shabazz v. Kraft Heinz, et al.&lt;/em&gt;, No. 515681/2026 (N.Y. Sup. Ct., Kings Cty.); &lt;em&gt;Peters v. Kraft Heinz, et al.&lt;/em&gt;, No. 26CV006540 (Ga. Super. Ct., Fulton Cty.). An eighth case, &lt;em&gt;Jenkins v. Kraft Heinz, et al.&lt;/em&gt;, No. 2:26-cv-00115 (E.D. La.), was voluntarily dismissed before any motion practice occurred.]] Several of those cases, for example, &lt;em&gt;Lawton v. Kraft Heinz&lt;/em&gt;, in which the defendants&amp;rsquo; motion to dismiss is pending, involve substantially fewer brands than the 179 products cited in &lt;em&gt;Martinez&lt;/em&gt;. Plaintiffs may file new cases that are focused on a smaller number of products with more individualized dose-response allegations. &lt;/p&gt;
&lt;p style="text-align: center;"&gt;* &amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; * &amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has been tracking these developments and counseling clients on compliance and litigation strategy in the UPF space. Our team is here to help with any questions you may have.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{ECB10C71-0C0F-4CC4-BE88-933319AC4672}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/capital-snapshot-july-2026</link><a10:author><a10:name>Eugenia E. Pierson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pierson-eugenia-e</a10:uri><a10:email>Eugenia.Pierson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Allison Jarus</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jarus-allison</a10:uri><a10:email>allison.jarus@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter E. Duyshart</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/duyshart-peter</a10:uri><a10:email>peter.duyshart@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Crawford</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/crawford-emily</a10:uri><a10:email>emily.crawford@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Mahaffy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mahaffy-emily</a10:uri><a10:email>emily.mahaffy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dylan L. Kelemen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kelemen-dylan-l</a10:uri><a10:email>dylan.kelemen@arnoldporter.com</a10:email></a10:author><title>Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions</title><description>Our Legislative &amp;amp; Public Policy team is pleased to provide the July 2026 edition of &lt;em&gt;Capital Snapshot&lt;/em&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions.</description><pubDate>Fri, 10 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Our Legislative &amp;amp; Public Policy team is pleased to provide the July 2026 edition of &lt;em&gt;Capital Snapshot&lt;/em&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the &lt;em&gt;Capital Snapshot&lt;/em&gt; contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, recently-announced vacancies and special elections, and notable incumbent primary election losses. We also share updates on the FY 2027 federal funding and appropriations processes. Additionally, our team provides comprehensive updates on the latest with trade and tariffs. Furthermore, we share some salient legislative and policy updates across a variety of additional key policy areas, including: (1) defense; (2) tax; (3) financial services; (4) artificial intelligence; (5) technology; (6) data privacy; (7) health care; (8) education; and (9) energy and environment. Furthermore, we provide an overview and outlook of the upcoming 2026 midterm elections in November, including the latest developments with the Maine and Michigan U.S. Senate contests, as well as a recap of various mid-decade redistricting efforts across the country ahead of the midterms. Our team also takes a look at current public opinion polling on President Trump&amp;rsquo;s job performance and policy priorities, and assesses economic factors and conditions that could impact the political landscape when voters head to the polls in November.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{68519E68-FA50-4079-9280-998F43841040}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/anti-corruption-report-features-daniel-bernstein-in-compliance-reps-and-warranties-series</link><title>Anti-Corruption Report Features Daniel Bernstein in Compliance Reps and Warranties Series</title><description>Daniel Bernstein, Arnold &amp;amp; Porter White Collar Defense &amp;amp; Investigations counsel, was recently quoted in a four-part &lt;em&gt;Anti-Corruption Report&lt;/em&gt; series examining the role of compliance representations and warranties in managing legal and regulatory risk.</description><pubDate>Thu, 09 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Daniel Bernstein, Arnold &amp;amp; Porter White Collar Defense &amp;amp; Investigations counsel, was recently quoted in a four-part &lt;em&gt;Anti-Corruption Report&lt;/em&gt; series examining the role of compliance representations and warranties in managing legal and regulatory risk.&lt;/p&gt;
&lt;p&gt;The first article addressed the continuing relevance of compliance reps and warranties. In the piece, Daniel noted that compliance representations and warranties &amp;ldquo;are a form of legal protection and risk allocation,&amp;rdquo; as well as an &amp;ldquo;expression of a company&amp;rsquo;s values and of what matters to a company.&amp;rdquo; &amp;ldquo;They are an indication of what the company and its stakeholders care about,&amp;rdquo; he said.&lt;/p&gt;
&lt;p&gt;The second article covered negotiation. &amp;ldquo;Whether compliance representations and warranties are heavily negotiated or mere boilerplate often depends on the complexity of the transaction and the money at stake, as well as on various risk factors,&amp;rdquo; Daniel explained. &amp;ldquo;There are costs associated with negotiating more specific representations and warranties,&amp;rdquo; but transactions that &amp;ldquo;present particular risks &amp;hellip; may make more bespoke representations and warranties appropriate.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;The third article addressed verification and enforcement, including due diligence, site visits, transaction testing, and ongoing monitoring. Daniel noted that often &amp;ldquo;compliance representations and warranties are accompanied by audit rights.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The fourth article covered how reps and warranties have adapted to emerging risks in M&amp;amp;A and third-party relationships. He discussed how, in addition to anti-corruption compliance, &amp;ldquo;a lot of international companies are now paying more attention to tariffs, export controls and sanctions.&amp;rdquo; These risks are &amp;ldquo;not necessarily new&amp;rdquo; but are evolving.&lt;/p&gt;
&lt;p&gt;Read the &lt;a rel="noopener noreferrer" href="https://www.anti-corruption.com/21409766/compliance-reps-and-warranties-definitions-and-goals.thtml" target="_blank"&gt;first&lt;/a&gt;, &lt;a rel="noopener noreferrer" href="https://www.anti-corruption.com/21415821/compliance-reps-and-warranties-negotiations.thtml" target="_blank"&gt;second&lt;/a&gt;, &lt;a rel="noopener noreferrer" href="https://www.anti-corruption.com/21428731/compliance-reps-and-warranties-verification-and-enforcement.thtml" target="_blank"&gt;third&lt;/a&gt;, and &lt;a rel="noopener noreferrer" href="https://www.anti-corruption.com/21462546/compliance-reps-and-warranties-adapting-to-emerging-risks.thtml" target="_blank"&gt;fourth&lt;/a&gt; installments (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{4786DE4F-32CB-4B8E-8E85-9ECCFCD2B5D6}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/evan-rothstein-quoted-in-law360-on-key-midyear-patent-decisions</link><title>Evan Rothstein Quoted in Law360 on Key Midyear Patent Decisions</title><description>Evan Rothstein, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Intellectual Property practice, was quoted in the &lt;em&gt;Law360 &lt;/em&gt;article, &amp;ldquo;Biggest Rulings For Patent Attys In 2026: A Midyear Report,&amp;rdquo; which examines several of the year's most significant patent decisions from the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit.</description><pubDate>Thu, 09 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Evan Rothstein, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Intellectual Property practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Biggest Rulings For Patent Attys In 2026: A Midyear Report,&amp;rdquo; which examines several of the year's most significant patent decisions from the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit.&lt;/p&gt;
&lt;p&gt;Evan discussed the Federal Circuit's decision in &lt;em&gt;A.L.M. Holding Co. v. Zydex Industries Private Ltd.&lt;/em&gt;, where he said the ruling provides "instructions" for patent owners when drafting exclusive license agreements to help ensure they have standing to bring infringement claims.&lt;/p&gt;
&lt;p&gt;Evan also highlighted another Federal Circuit ruling that he described as a significant win for patent owners because it rejected a "per se, categorical rule" that would have barred consideration of non-infringing products in reasonable royalty analyses. He explained that where infringement of one component enhances the performance or value of related products, "I can use that ancillary benefit in the other parts of the stack in my calculation of what would be part of the hypothetical negotiation for reasonable royalties."&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2498166/biggest-rulings-for-patent-attys-in-2026-a-midyear-report" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{3A0F8364-189C-4DB2-9F14-A7A213B17DC0}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/arnold-porter-advises-aurobindo-pharma-in-ftc-clearance-for-acquisition-of-lannett-company</link><title>Arnold &amp; Porter Advises Aurobindo Pharma in FTC Clearance for Acquisition of Lannett Company</title><description>Arnold &amp;amp; Porter recently represented Aurobindo Pharma Limited in obtaining Federal Trade Commission (FTC) clearance for its acquisition of Lannett Company, Inc., a manufacturer of generic pharmaceutical products, in a transaction valued at approximately $250 million.</description><pubDate>Thu, 09 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently represented Aurobindo Pharma Limited in obtaining Federal Trade Commission (FTC) clearance for its acquisition of Lannett Company, Inc., a manufacturer of generic pharmaceutical products, in a transaction valued at approximately $250 million.&lt;/p&gt;
&lt;p&gt;The transaction involved overlapping marketed and pipeline generic pharmaceutical products. Following the firm's advocacy before the FTC, the agency narrowed its competitive concerns to four products: mycophenolate mofetil oral suspension, niacin extended-release tablets, pilocarpine tablets, and rabeprazole sodium delayed-release tablets.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter negotiated a consent agreement with the FTC under which Aurobindo agreed to divest those four products to Quagen Pharmaceuticals LLC, enabling the transaction to proceed. The FTC voted 2-0 to accept the consent agreement for public comment and granted early termination of the Hart-Scott-Rodino waiting period on June 18, 2026, permitting the acquisition to close.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Antitrust partners Debbie Feinstein and David Emanuelson, counsel Barbara Wootton, and senior associate Andrew Ellingsen. Partner Betty Yan, co-head of the Life Sciences Transaction practice, also advised on the acquisition.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E7D512E2-C7A7-45A6-954B-8B62D4F0EC60}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/oversight-of-laboratory-developed-tests-one-year-after-acla-v-fda</link><a10:author><a10:name>Mahnu V. Davar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/davar-mahnu-v</a10:uri><a10:email>mahnu.davar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Philip R. Desjardins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/desjardins-philip-r</a10:uri><a10:email>philip.desjardins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bobby McMillin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mcmillin-bobby</a10:uri><a10:email>bobby.mcmillin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Monique Nolan, M.D., J.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nolan-monique</a10:uri><a10:email>monique.nolan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Claire W. Dennis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dennis-claire</a10:uri><a10:email>claire.dennis@arnoldporter.com</a10:email></a10:author><title>Oversight of Laboratory Developed Tests One Year After ACLA v. FDA: Assessing Legislative Proposals in Context</title><description>Our latest Advisory examines the current state of laboratory developed test oversight, highlights key developments since the court&amp;rsquo;s decision, and explores what stakeholders should be watching as policymakers consider future regulatory approaches.</description><pubDate>Thu, 09 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Advances in genetic medicine, coupled with recent breakthroughs in mental health and weight management, have renewed the scientific community&amp;rsquo;s attention on the role of biomarkers in the management of disease and development of new therapeutics. Similarly, the success of expedited therapeutic approval programs and a public-private shared interest in speeding the pace of clinical trials has refocused attention on the role of validating new analytes as potential surrogates. Coupled with the rapid scaling now possible with artificial intelligence (AI), we are seeing an explosion in interest in next-generation diagnostics and wellness tools, many of which are testing existing and often outdated state and federal regulatory frameworks. Unsurprisingly, this has refreshed calls to modernize, but not hinder, the development of laboratory-developed tests, including through a proposal to expand the Centers for Medicare &amp;amp; Medicaid Services&amp;rsquo; (CMS) role.&lt;/p&gt;
&lt;p&gt;Laboratory-developed tests (LDTs) are part of a continuing debate over the appropriate scope and structure of federal oversight. The central regulatory question is how to support reliable test performance and appropriate clinical use &amp;mdash; within the existing legal framework &amp;mdash; while preserving the ability of laboratories to adapt to changing scientific and clinical needs. That balance is increasingly difficult because many modern tests rely on complex algorithms or data analysis that can resemble device or software functions even when the test is offered as a laboratory service. &lt;/p&gt;
&lt;p&gt;The current LDT landscape presents both opportunity and risk for laboratories, test developers, diagnostic manufacturers, software companies, investors, and drug developers. Although U.S. Food and Drug Administration&amp;rsquo;s (FDA) 2024 LDT Final Rule was vacated by a court, and FDA has rescinded that rule, the absence of a comprehensive FDA framework does not mean the absence of regulatory scrutiny. Rather, the oversight environment has become more fragmented, with FDA, CMS, state laboratory regulators, accreditation bodies, payers, Federal Trade Commission (FTC), and private litigants each retaining potential roles depending on the test, claims, technology, and commercial model.&lt;/p&gt;
&lt;p&gt;For companies operating in this space, the most important takeaway is that LDT strategy should not be treated as a narrow laboratory-compliance issue. LDT policy now intersects with product development, clinical evidence generation, reimbursement, software regulation, promotional review, commercialization strategy, transactional diligence, and risk management. Companies that account for these issues early will be better positioned to bring tests to market, support payer coverage, withstand regulatory scrutiny, and preserve options if Congress or CMS moves toward a more formalized Clinical Laboratory Improvement Amendment (CLIA)-based framework.&lt;/p&gt;
&lt;h2&gt;What Authority Does FDA Likely Continue to Retain?&lt;/h2&gt;
&lt;p&gt;In 2024, FDA sought to formalize its long-asserted authority over laboratory-developed tests by issuing a final rule that would have regulated most LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. The rule was issued during the Biden administration after Congress considered &amp;mdash; but ultimately declined to enact &amp;mdash; comprehensive LDT reform legislation known as the Verifying Accurate and Leading-edge IVCT Development (VALID) Act that would have created a new category of &amp;ldquo;in vitro clinical tests&amp;rdquo; which would have subjected LDTs to FDA oversight.
&lt;/p&gt;
&lt;p&gt;&lt;a href="/en/perspectives/advisories/2024/05/fdas-final-laboratory-developed-test-rule"&gt;FDA promulgated a regulation&lt;/a&gt; that was a significant shift away from FDA&amp;rsquo;s historical enforcement discretion approach and would have subjected laboratories to device requirements such as premarket review, quality system regulation, and adverse event reporting. &lt;a href="/en/perspectives/advisories/2024/12/ldt-final-rule-litigation"&gt;The rule was immediately met with industry challenge&lt;/a&gt;, culminating in litigation before the U.S. District Court for the Eastern District of Texas, which vacated FDA&amp;rsquo;s regulation in May 2025. FDA did not appeal that ruling, and the second Trump administration subsequently rescinded the rule. This effectively reverted FDA&amp;rsquo;s oversight over LDTs to its prior limbo, with the agency continuing to assert jurisdiction over certain aspects of diagnostic products, including test components, distributed kits, and software. As a result, manufacturers and laboratories that rely on commercially distributed equipment and reagents remain subject to FDA requirements at least in some respects.&lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s longstanding policies governing research use only (RUO) and investigational use only (IUO) products also remain an important enforcement tool in this context. Under these policies, products that are labeled and distributed for research or investigational purposes may not be promoted for clinical diagnostic use, and FDA has historically taken action where marketing practices suggest otherwise. Written RUO-related guidance is narrow, non-binding, and unfortunately predates the advent of software algorithms as an essential component to complex or high-throughput diagnostics. Still, these policies remain relevant for laboratories that rely on RUO-labeled reagents or components to develop LDTs, as FDA may scrutinize whether such products are, in practice, being used or promoted for clinical purposes. &lt;/p&gt;
&lt;p&gt;Together, these authorities reinforce that, even in the absence of a comprehensive LDT rule, FDA retains jurisdiction over the commercialization of the tangible inputs into LDT development, even if the agency may not regulate the laboratory service itself. Thus, FDA continues to play a meaningful role in the regulation of diagnostic testing.&lt;/p&gt;
&lt;p&gt;FDA also regulates certain software functions associated with diagnostic testing. For example, software that meets the definition of Software as a Medical Device (SaMD) may be regulated as a device, e.g., where it is intended to analyze or interpret medical information for clinical use. This is increasingly relevant in the LDT context, as many modern tests incorporate algorithm-driven analyses, including gene profiling, risk scoring, and other data-intensive outputs. As with physical devices, FDA&amp;rsquo;s authority in this area turns on intended use, including how the software is designed, described, and marketed. Accordingly, even where an underlying test may be treated as an LDT, standalone or integrated software components may independently be subject to FDA oversight.&lt;/p&gt;
&lt;p&gt;Despite FDA&amp;rsquo;s jurisdiction over such components even after vacatur of the LDT Final Rule, and perhaps because FDA is wary of drawing another legal challenge, the agency&amp;rsquo;s enforcement in this space has remained limited. We expect that to continue, with narrowly targeted enforcement that is focused on components of LDT services that remain neatly within FDA&amp;rsquo;s recognized device authorities or raise significant public health issues, such as misdiagnosis or underdiagnosis of serious or life-threatening conditions. Use of LDTs as diagnostics for drug use may also give FDA a jurisdictional lever, though here too, FDA may be reticent to take enforcement action. Laboratories and manufacturers should therefore continue to assess claims, labeling, distribution models, and validation support for products used in testing workflows, with special attention to the use of software in both sample analysis and results-report development and interpretation. &lt;/p&gt;
&lt;p&gt;In parallel, CMS, state programs, accreditation organizations, payers, and the FTC may remain relevant to oversight depending on the test, the claims made, and the commercial model. DOJ&amp;rsquo;s increased attention over the use of AI in healthcare &amp;mdash; particularly where AI is used to perform or output Medicare-reimbursed clinical care &amp;mdash; suggests the need for diagnostics companies and providers to perform thoughtful diligence on their software providers and conduct regulatory and quality analysis on the integration of software into sample analysis, report creation, and billing workflows. Taken together, the practical result of these shifts in LDT oversight attention is not the absence of enforcement risk, but a more fragmented oversight environment requiring careful attention to the source of authority for each component of the testing ecosystem.&lt;/p&gt;
&lt;h2&gt;Emerging Opportunities for the Diagnostics Community to Shape Oversight?&lt;/h2&gt;
&lt;p&gt;In the wake of FDA&amp;rsquo;s unsuccessful effort to assert comprehensive authority over LDTs through rulemaking, attention has shifted toward alternative frameworks for oversight. Some policymakers and stakeholders have appeared to coalesce around the view that LDT oversight may be more appropriately situated within the existing CLIA framework administered by CMS, rather than through an expansion of FDA&amp;rsquo;s device authorities.&lt;/p&gt;
&lt;p&gt;This emerging view reflects, in part, the existence of established mechanisms within the current regulatory landscape that already address elements of test quality and validity. For example, the New York State Clinical Laboratory Evaluation Program (CLEP) has long served as a model for pre-use review of certain laboratory-developed tests, including assessments of analytical and clinical validity. In addition, some LDTs have historically relied on prior FDA clearance or approval pathways, while others are evaluated through payer-driven processes such as MolDx coverage, which assesses clinical validity and utility in the context of reimbursement. Policymakers have also shown increasing interest in the potential role of certified third-party reviewers to provide independent validation of test performance. Together, these existing approaches suggest a potential path forward in which CLIA serves as the core regulatory framework, supplemented by targeted mechanisms to ensure test quality and clinical reliability without fully subjecting LDTs to the medical device regulatory regime.&lt;/p&gt;
&lt;h2&gt;Recently Proposed Legislation&lt;/h2&gt;
&lt;p&gt;On May 19, 2026, Representative Neal Dunn (R-FL) introduced the &lt;a rel="noopener noreferrer" href="https://www.congress.gov/119/bills/hr8890/BILLS-119hr8890ih.pdf" target="_blank"&gt;Enhancing Clinical Laboratory Innovation and Access Act of 2026&lt;/a&gt;, which reflects a legislative effort to recalibrate federal oversight of laboratory-developed tests by codifying a shift away from the FDA&amp;rsquo;s device-based framework. At its core, the proposal would clarify that LDTs are not medical devices under the Federal Food, Drug, and Cosmetic Act and fall within the scope of an updated and expanded CLIA framework administered by CMS. In doing so, the legislation seeks to provide long-sought jurisdictional clarity while establishing a pathway for more tailored, laboratory-focused oversight.&lt;/p&gt;
&lt;p&gt;Rather than representing a deregulatory approach, unlike previous CMS-oriented efforts such as the Verified Innovative Testing in American Laboratories (VITAL) Act, the bill reflects a reallocation of regulatory authority, shifting primary responsibility for LDT oversight from FDA to CMS while maintaining, and in some respects expanding, requirements relating to test validity, transparency, and post-market oversight. In this respect, the proposed legislation is consistent with historical attempts to enhance LDT regulatory oversight, suggesting that future reform efforts will focus on building out the CLIA framework as the central mechanism for LDT regulation.&lt;/p&gt;
&lt;p&gt;The window for legislative activity is narrowing as we approach November&amp;rsquo;s elections. For those monitoring the bill&amp;rsquo;s chances of success, they should note whether the legislation picks up additional cosponsors, receives committee consideration, and whether we see the introduction of a Senate companion. &lt;/p&gt;
&lt;p&gt;Notably, CMS has prepared a Request for Information (RFI) titled &amp;ldquo;Request for Information; Clinical Laboratory Improvement Amendment (CLIA) of 1988 Regulations (CMS-3485)&amp;rdquo; and the Office of Management and Budget concluded its review of the RFI on July 7, 2026. With the imminent release of the RFI and renewed attention by Congress, this presents an immediate opportunity for public input on the agency&amp;rsquo;s CLIA regulations.&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The vacatur of FDA&amp;rsquo;s LDT Final Rule reduced, for the moment, the impending burden that would have accompanied FDA premarket review, quality system regulation, and medical device reporting for many LDTs. However, pending and potential legislative activity, including proposals to modernize CLIA, indicates that policymakers remain focused on test validity, transparency, adverse event reporting, and patient safety. Companies should use this period to assess their LDT portfolios, identify higher-risk tests, and build regulatory strategies that can adapt to future federal action. At the same time, the evolving LDT environment creates opportunities for acquisitions, licensing arrangements, laboratory partnerships, pharma and biotech collaborations, and commercialization deals.&lt;/p&gt;
&lt;p&gt;As covered in our previous advisories, LDTs have been the subject of significant regulatory and legislative action in recent years. We note relevant recent developments below.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="/en/perspectives/advisories/2023/10/fda-proposes-to-actively-regulate-laboratory-developed-tests"&gt;FDA Proposes to Actively Regulate Laboratory-Developed Tests After Years of Enforcement Discretion&lt;/a&gt; (October 2023)&lt;/li&gt;
    &lt;li&gt;&lt;a href="/en/perspectives/advisories/2024/05/fdas-final-laboratory-developed-test-rule"&gt;FDA Intends To Regulate Many Clinical Labs as Medical Device Manufacturers: What You Need To Know About the Laboratory Developed Test Final Rule Issued&lt;/a&gt; (May 2024)&lt;/li&gt;
    &lt;li&gt;&lt;a href="/en/perspectives/advisories/2024/12/ldt-final-rule-litigation"&gt;LDT Final Rule Litigation. Status of Pending Court Challenges and What May Happen Next&lt;/a&gt; (December 2024)&lt;/li&gt;
    &lt;li&gt;&lt;a href="/en/perspectives/advisories/2025/04/ldts-are-not-devices-under-the-fdca"&gt;LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs&lt;/a&gt; (April 2025)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Please contact one of the authors of this Advisory or your regular Arnold &amp;amp; Porter contact if you are interested in discussing strategies in this space. Among other topics, our team can assist you in assessing whether software components may independently implicate FDA&amp;rsquo;s medical device authorities, conduct due diligence, evaluate reimbursement and market access considerations, and review materials to ensure claims are adequately supported and tailored based on the current enforcement environment.&amp;nbsp; &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F3A6F234-CED7-4108-8C71-84268F75DE0A}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/john-elwood-discusses-supreme-court-and-federal-appeals-court-decisions-in-law360</link><title>John Elwood Discusses Supreme Court and Federal Appeals Court Decisions in Law360</title><description>John Elwood, head of Arnold &amp;amp; Porter&amp;rsquo;s Appellate and Supreme Court practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;After Tense Terms, Hints Of High Court Harmony With Circuits,&amp;rdquo; discussing signs of increasing alignment between the U.S. Supreme Court and the federal courts of appeals during the Court's latest term.</description><pubDate>Wed, 08 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;John Elwood, head of Arnold &amp;amp; Porter&amp;rsquo;s Appellate and Supreme Court practice, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;After Tense Terms, Hints Of High Court Harmony With Circuits,&amp;rdquo; discussing signs of increasing alignment between the U.S. Supreme Court and the federal courts of appeals during the Court's latest term.&lt;/p&gt;
&lt;p&gt;Elwood observed that appellate courts issued fewer "outlier" decisions this term, noting that "there were definitely fewer outlier decisions, I would say, or fewer really red-letter decisions, where everybody in the legal community was talking about it the next day."&lt;/p&gt;
&lt;p&gt;He also explained that several of the Supreme Court's reversals reflected changes in the Court's own precedent rather than errors by the lower courts. "You can't fault the courts of appeals" in those situations, Elwood said. "They're doing their job if they apply existing law and leave it to the Supreme Court to overrule [its] own precedents."&lt;/p&gt;
&lt;p&gt;&lt;a href="https://www.law360.com/articles/2495020/after-tense-terms-hints-of-high-court-harmony-with-circuits"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C11F3BB3-D4BA-42E7-84E1-9F61F837ED2E}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/law360-quotes-patrick-madden-on-third-circuit-flsa-gap-time-decision</link><title>Law360 Quotes Patrick Madden on Third Circuit FLSA Gap Time Decision</title><description>Patrick Madden, a partner in the firm&amp;rsquo;s Labor &amp;amp; Employment group, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "5 Major Wage And Hour Rulings So Far In 2026," which examines several significant wage-and-hour decisions issued during the first half of 2026.</description><pubDate>Wed, 08 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Patrick Madden, a partner in the firm&amp;rsquo;s Labor &amp;amp; Employment group, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, "5 Major Wage And Hour Rulings So Far In 2026," which examines several significant wage-and-hour decisions issued during the first half of 2026.&lt;/p&gt;
&lt;p&gt;Commenting on the Third Circuit's decision in &lt;em&gt;Secretary United States Department of Labor v. Comprehensive Healthcare Management Services LLC et al.&lt;/em&gt;, Patrick discussed the court's precedential ruling that the Fair Labor Standards Act (FLSA) does not provide a remedy for unpaid straight-time, or "gap time," wages in workweeks where an employee's average hourly pay still exceeds the federal minimum wage. &lt;/p&gt;
&lt;p&gt;He noted that while the decision seeks to provide clarity on an issue that has been litigated for decades, it also raises questions that many federal courts have previously avoided addressing. Patrick observed that there is a split in the courts of appeals and the ruling "is directly addressing an issue that a lot of courts of appeals have specifically avoided," highlighting its potential for possible Supreme Court review and significance for future wage-and-hour litigation.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/employment-authority/articles/2494924?" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A4DE7511-99C1-477B-ABFE-2670161127DA}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/07/antitrust-agency-insights-developments-at-the-us-antitrust-enforcement-agencies-second-quarter-2026</link><author>matthew.tabas@arnoldporter.com</author><title>Antitrust Agency Insights: Developments at the U.S. Antitrust Enforcement Agencies — Second Quarter 2026</title><description>Successfully navigating antitrust agency investigations requires a familiarity with Department of Justice and Federal Trade Commission processes, as well as insight into those agencies and their leaderships&amp;rsquo; current priorities for enforcement and competition policy. This Newsletter will provide periodic updates on both, offering an analytical look at how the antitrust agencies are approaching important competition issues and what current investigations may mean for potential future enforcement. We hope our experience &amp;mdash; both inside and outside these agencies &amp;mdash; will provide insights that help you make more informed decisions for your business.</description><pubDate>Wed, 08 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Letter From the Editors&lt;/h2&gt;
&lt;p&gt;Traditionally, the U.S. Federal Trade Commission (FTC or the Commission) and the Antitrust Division of the U.S. Department of Justice (DOJ or DOJ Antitrust) have used pre-litigation merger settlements to resolve challenged deals. Although such remedies fell out of favor during the Biden administration, FTC and DOJ leadership in both Trump administrations have accepted divestitures to resolve competitive concerns. In most instances, the agencies have decried behavioral remedies as ineffective relief to anticompetitive mergers and acquisitions. Recently, however, Associate Attorney General Stanley Woodward has reportedly told DOJ Antitrust to seek settlements[[N: Dana Mattioli, Dave Michaels &amp;amp; Joe Palazzolo, &lt;a rel="noopener noreferrer" href="https://www.wsj.com/politics/policy/top-doj-official-tells-staff-he-wants-to-avoid-antitrust-trials-bc5a23ce" target="_blank"&gt;Top DOJ Official Tells Staff He Wants to Avoid Antitrust Trials&lt;/a&gt;, &lt;em&gt;Wall St. J.&lt;/em&gt; (June 25, 2026).]] and the FTC has signaled a potential willingness to consider behavioral remedies in settlements.&lt;/p&gt;
&lt;h3&gt;Behavioral Remedies Under Both Trump Administrations Prior to 365 Retail Markets&lt;/h3&gt;
&lt;p&gt;Antitrust leadership during the first Trump administration was clear that behavioral remedies were disfavored. Former Assistant Attorney General (AAG) Makan Delrahim framed the issue in stark terms, emphasizing that &amp;ldquo;antitrust is law enforcement, it&amp;rsquo;s not regulation,&amp;rdquo; and warning that &amp;ldquo;behavioral remed[ies] supplant[] competition with regulation.&amp;rdquo;[[N: Makan Delrahim, Assistant Att&amp;rsquo;y Gen., U.S. Dep&amp;rsquo;t of Justice, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/archives/opa/speech/file/1012086/dl" target="_blank"&gt;Keynote Address at the American Bar Association&amp;rsquo;s Antitrust Fall Forum&lt;/a&gt; (Nov. 16, 2018).]] He further explained that such remedies &amp;ldquo;require centralized decisions instead of a free market process&amp;rdquo; and &amp;ldquo;set static rules devoid of the dynamic realities of the market.&amp;rdquo; Similarly, Former FTC Chairman Joe Simons articulated a similar view, explaining that the Commission would accept behavioral remedies only in &amp;ldquo;rare, very limited circumstances.&amp;rdquo;[[N: &lt;a rel="noopener noreferrer" href="https://www.mlex.com/mlex/articles/1951282/ftc-accepts-use-of-behavioral-remedies-in-rare-very-limited-circumstances-simons-says" target="_blank"&gt;FTC Accepts Use of Behavioral Remedies in Rare, Very Limited Circumstances, Simons Says&lt;/a&gt;, &lt;em&gt;MLex&lt;/em&gt; (June 20, 2018).]] Consistent with this approach, Chairman Simons identified defense industry transactions involving a single government customer as one of the few contexts in which behavioral remedies might be appropriate. Taken together, these statements reflect a consistent enforcement philosophy: behavioral remedies were disfavored because of their perceived administrability challenges, reliance on continued monitoring, and risk of distorting market incentives over time.&lt;/p&gt;
&lt;p&gt;Reflecting the narrow circumstances outlined by Chairman Simons, in 2018, the FTC accepted behavioral remedies in Northrop Grumman&amp;rsquo;s vertical merger with Orbital ATK.[[N: Northrop Grumman Corp., 165 F.T.C. 1236, 1240 (2018) (decision and order).&amp;nbsp;]] Northrop was &amp;ldquo;one of four companies capable of supplying the U.S. government with missile systems,&amp;rdquo; and Orbital was the largest supplier of Solid Rocket Motors (SRMs), which are an essential component for missile systems.[[N: Press Release, Fed. Trade Comm&amp;rsquo;n, &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2018/06/ftc-imposes-conditions-northrop-grummans-acquisition-solid-rocket-motor-supplier-orbital-atk-inc" target="_blank"&gt;FTC Imposes Conditions on Northrop Grumman&amp;rsquo;s Acquisition of Solid Rocket Motor Supplier Orbital ATK, Inc.&lt;/a&gt; (June 5, 2018).]] The settlement required Northrop to sell SRMs and related services to Northrop&amp;rsquo;s three competitors in supplying the United States with missile systems and imposed a firewall, which separated Northrop&amp;rsquo;s general operations from their SRM division. &lt;/p&gt;
&lt;p&gt;Antitrust leadership in the second Trump administration continued course, expressing preference for divestitures and discomfort with behavioral remedies. In his statement regarding the FTC&amp;rsquo;s May 2025 settlement in Synopsys&amp;rsquo; merger with Ansys, current FTC Chairman Andrew Ferguson articulated this viewpoint: &lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&amp;ldquo;[T]he Trump FTC must be open to settling merger cases &amp;hellip; but behavioral remedies should be treated with substantial caution. They are often difficult or impossible for the Commission to enforce effectively and can lock the Commission into the status of a monitor for individual firms rather than a guardian of competition across the entire economy&amp;hellip;. [The Commission&amp;rsquo;s] strong preference should be for structural remedies over conduct remedies.[[N: &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/synopsys-ansys-ferguson-statement-joined-by-holyoak-meador.pdf" target="_blank"&gt;Statement of Chairman Andrew N. Ferguson Joined by Commissioner Melissa Holyoak and Commissioner Mark R. Meador&lt;/a&gt;, In the Matter of Synopsys, Inc./Ansys, Inc., at 7-8 (Fed. Trade Comm&amp;rsquo;n).]]&lt;/p&gt;
&lt;p&gt;Former Deputy Assistant Attorney General Bill Rinner made similar statements in June 2025. Speaking at George Washington University, Deputy Assistant Attorney General (DAAG) Rinner explained that under the Trump administration, &amp;ldquo;[s]tructural remedies are preferred as an &amp;ldquo;efficient default&amp;rdquo; principle, primarily informed by their record of effectiveness compared to behavioral remedies.&amp;rdquo;[[N: Bill Rinner, Deputy Assistant Att&amp;rsquo;y Gen., U.S. Dep&amp;rsquo;t of Justice, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/daag-bill-rinner-delivers-remarks-george-washington-university-competition-and" target="_blank"&gt;Remarks at the George Washington University Competition and Innovation Lab Conference Regarding Merger Review and Enforcement&lt;/a&gt; (June 4, 2025).]] He added that there may be times when behavioral remedies offer &amp;ldquo;necessary and adequate support&amp;rdquo; to structural relief, but that this caveat &amp;ldquo;is not an invitation to morph behavioral commitments into structural relief through costly legal alchemy.&amp;rdquo;&lt;/p&gt;
&lt;h3&gt;Behavioral Remedy in the 365 Retail Markets/Cantaloupe Settlement&lt;/h3&gt;
&lt;p&gt;On May 1, 2026, however, the FTC announced a settlement in its investigation of 365 Retail Markets LLC&amp;rsquo;s acquisition of Cantaloupe, Inc., which included a behavioral remedy.[[N: Providence Equity Partners L.L.C., FTC Matter No. 252-3161, at 8-9 (June 15, 2026) (&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/PEPCantaloupe-FinalOrder.pdf" target="_blank"&gt;decision and order&lt;/a&gt;).]] According to the FTC, 365 Retail is the nation&amp;rsquo;s largest provider of micromarket kiosks &amp;mdash; small, unattended markets that sell fresh produce found in offices. Cantaloupe owned point-of-sale software used by micromarket kiosks and Three Square Market &amp;mdash; the second largest micromarket kiosk provider. The FTC alleged that the proposed acquisition would have eliminated competition in the micromarket kiosk market, and that 365 Retail could hinder software integration with competitors, driving up the cost of micromarket kiosks.[[N: Press Release, Fed. Trade Comm&amp;rsquo;n, &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/05/ftc-takes-action-protect-consumers-anticompetitive-effects-micromarket-kiosks-deal" target="_blank"&gt;FTC Takes Action to Protect Consumers from Anticompetitive Effects of Micromarket Kiosks Deal&lt;/a&gt; (May 1, 2026).]] The FTC settlement resolved these concerns by requiring Cantaloupe to divest the Three Square Market business. The settlement also required the post-merger company to offer integrations between its software and hardware on fair and non-discriminatory terms to customers and third parties for a 10-year period, and appointed a monitor to ensure 365 Retail&amp;rsquo;s compliance with the settlement.&lt;/p&gt;
&lt;p&gt;Prior to the 365 Retail/Cantaloupe settlement, the second Trump administration&amp;rsquo;s FTC previously accepted a behavioral remedy in Omnicom Group&amp;rsquo;s acquisition of the Interpublic Group of Companies, two leading advertising holding companies. However, the behavioral remedy addressed the Commission&amp;rsquo;s concerns that advertising agencies, including Omnicom after its acquisition of Interpublic, coordinated on decisions not to advertise on particular platforms,[[N: Omnicom Grp. Inc., FTC Matter No. 251-0049 (Sept. 26, 2025) (&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/2410059C4823OmnicomComplaint.pdf" target="_blank"&gt;complaint&lt;/a&gt;).]] &amp;ldquo;based on Political or ideological viewpoints.&amp;rdquo;[[N: Omnicom Grp. Inc., FTC Matter No. 251-0049, at 8 (Sept. 26, 2025) (&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/OmnicomOrder.pdf" target="_blank"&gt;decision and order&lt;/a&gt;).]]&lt;/p&gt;
&lt;p&gt;In contrast, the behavioral component of the 365 Retail remedy imposes an affirmative, third-party licensing requirement on the combined company. In his statement concerning the 365 Retail settlement, FTC Commissioner Mark Meador reiterated the FTC&amp;rsquo;s &amp;ldquo;strong preference for clean divestitures of standalone business lines,&amp;rdquo; but added that behavioral relief may nevertheless be appropriate when it is &amp;ldquo;enforceable and designed to address the competitive concern at issue, or directly support[s] the effectiveness of the structural relief.&amp;rdquo;[[N: &lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/meador-statement-providence-cantaloupe.pdf" target="_blank"&gt;Statement of Commissioner Mark R. Meador&lt;/a&gt;, In the Matter of Providence Equity Partners L.L.C. and Cantaloupe, Inc., at 6-7 (Fed. Trade Comm&amp;rsquo;n May 1, 2026).]] Commissioner Meador explained that here, 365 Retail could undermine the divestiture by restricting the purchaser of Three Square Market from using the necessary point-of-sale software at commercially reasonable prices. Thus, behavioral relief critically supported the long-term feasibility of spinning Three Square Market off of the combined 365 Retail and Cantaloupe. &lt;/p&gt;
&lt;p&gt;Immediately after the 365 Retail settlement, acting-Assistant Attorney General for Antitrust Omeed Assefi issued remarks slightly softening the DOJ&amp;rsquo;s stance on behavioral remedies: &amp;ldquo;In many cases, structural relief is more certain, effective, and cost-efficient than behavioral remedies,&amp;rdquo; but that &amp;ldquo;doesn&amp;rsquo;t mean structural relief is always preferable to behavioral relief. Structural relief simply allows us to use a scalpel, fix the problem, and get out of the way.&amp;rdquo;[[N: Omeed A. Assefi, Acting Assistant Att&amp;rsquo;y Gen., U.S. Dep&amp;rsquo;t of Justice, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/acting-assistant-attorney-general-omeed-assefi-delivers-remarks-engelberg-center" target="_blank"&gt;Remarks at the Engelberg Center on Innovation Law &amp;amp; Policy at NYU School of Law&lt;/a&gt; (May 7, 2026).]]&lt;/p&gt;
&lt;h3&gt;Takeaways&lt;/h3&gt;
&lt;p&gt;It remains to be seen whether the antitrust enforcement agencies will increasingly rely on behavioral remedies in merger settlements during the remainder of the second Trump administration. Nevertheless, the 365 Retail settlement shows a significant deviation from the Trump administration antitrust leadership&amp;rsquo;s prior positions regarding using behavioral remedies as a tool to address competitive concerns in mergers. Going forward, parties subject to an agency investigation should consider whether tailored behavioral relief will be required to support a structural remedy, and how it can be structured in a way to preserve the deal value and assuage enforcer concerns about enforceability.&lt;/p&gt;
&lt;p&gt;The 365 Retail settlement has meaningful implications for parties navigating merger investigations under the second Trump administration. Structural remedies remain the starting point. The FTC and DOJ continue to express a clear preference for divestitures, reiterating that they lack the administrability issues present in behavioral remedies. Parties should continue to expect that any proposed remedy package will need to include a robust structural component.&lt;/p&gt;
&lt;p&gt;However, the agencies&amp;rsquo; approach to behavioral remedies appears to be evolving in the current administration. Rather than rejecting them outright, the FTC has signaled a willingness to consider behavioral remedies, particularly where they are tightly scoped and directly support divestitures. Parties should consider whether conduct commitments can enhance the effectiveness of structural relief, especially in transactions involving vertical integration, digital platforms, or interoperability concerns. For example, non-discrimination obligations, access commitments, and interoperability requirements may be viable tools where they address specific risks of foreclosure or degradation.&lt;/p&gt;
&lt;p&gt;Finally, while the agencies&amp;rsquo; openness may have increased, it remains bounded. The 365 Retail settlement does not signal a shift toward broad or open-ended behavioral regulation. Instead, it reflects a pragmatic recognition that, in certain cases, narrowly tailored conduct provisions may be necessary to ensure that structural remedies achieve their intended competitive outcomes.&lt;/p&gt;
&lt;h3&gt;FTC Cases and Proceedings&lt;/h3&gt;
&lt;h4&gt;FTC Seeks Public Comment on Petition to Modify Northrop Grumman Final Order&lt;/h4&gt;
&lt;p&gt;On April 2, 2026, the FTC sought public comment on Northrop Grumman&amp;rsquo;s petition to reopen and set aside a final consent order involving Northrop Grumman&amp;rsquo;s 2018 acquisition of aerospace and defense contractor Orbital ATK. The final consent order requires Northrop Grumman to supply solid rocket motors, or SRMs, to competitors on a non-discriminatory basis. Northrop Grumman contends that the order is no longer necessary to preserve competition. The public comment period closed on May 4, 2026.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/04/ftc-seeks-public-comment-petition-modify-northrop-grumman-final-order" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Orders Rollins, Inc. to Stop Enforcing Noncompete Agreements&lt;/h4&gt;
&lt;p&gt;On June 22, 2026, the FTC finalized its consent order with Rollins, Inc. The consent order requires that Rollins, a pest control company, cease enforcing non-compete agreements among its employees. The FTC alleged that the company&amp;rsquo;s noncompete agreements prohibited employees from working in pest control within a predetermined distance, typically within a 75-mile radius from one of Rollins&amp;rsquo; more than 700 locations in the U.S. The FTC also sent warning letters to other pest-control companies to review their employment agreements for potentially anticompetitive noncompete provisions.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-approves-final-consent-order-pest-control-noncompete-matter" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/251_0011_rollins_complaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/251_0011_rollins_do_public.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Reaches Settlement With Advertising Companies WPP, Publicis, and Dentsu&lt;/h4&gt;
&lt;p&gt;On April 15, 2026, the FTC reached a settlement requiring the advertising companies to cease using common brand safety standards and to not restrict advertising based on politically motivated criteria.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/04/ftc-takes-action-restore-competition-digital-advertising-ecosystem" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;span&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Dentsu-Complaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Dentsu-StipulatedOrder.pdf" target="_blank"&gt;Read the Injunction (Dentsu)&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/WPP-Order.pdf" target="_blank"&gt;Read the Injunction (WPP Media)&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Publicis-StipulatedOrder.pdf" target="_blank"&gt;Read the Injunction (Publicis)&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Reaches Settlement With U.S. Anesthesia Partners Inc. (USAP)&lt;/h4&gt;
&lt;p&gt;On April 23, 2026, the FTC settled pending litigation with USAP. The FTC had alleged that USAP engaged in unlawful monopolization in purchasing other Texas-based anesthesia providers. The terms of the settlement remain confidential to allow USAP to execute the settlement&amp;rsquo;s obligations.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/04/ftc-charts-path-restore-competition-texas-anesthesia-markets-usap-litigation" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Finalizes Consent Order in Valvoline-Greenbriar Deal&lt;/h4&gt;
&lt;p&gt;On May 7, 2026, the FTC finalized a consent order resolving antitrust concerns related to a deal between Valvoline Inc. and private equity firm Greenbriar Equity Fund V., L.P. (Greenbriar). The consent order requires the divestiture of 45 quick-lube oil change shops to address antitrust concerns surrounding Valvoline&amp;rsquo;s acquisition of approximately 200 quick-lube oil change outlets from Greenbriar. The FTC&amp;rsquo;s complaint alleges that the acquisition would eliminate competition across 25 local markets where Valvoline and Oil Changers, a subsidiary of Greenbriar, directly compete in offering quick-lube oil changes. Under the terms of the FTC&amp;rsquo;s final order, Main Street Auto LLC will acquire the divested outlets from Greenbriar and operate them under the name Oil Changers.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/05/ftc-finalizes-consent-order-valvoline-greenbriar-deal" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Valvoline-FinalComplaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Valvoline-FinalOrder.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Chair Andrew Ferguson Issues Warning Letter to Mortgage Connect&lt;/h4&gt;
&lt;p&gt;On May 8, 2026, FTC Chair Andrew Ferguson sent a warning letter to national mortgage services provider Mortgage Connect, urging the company to conduct a comprehensive review of its employment contracts, including any noncompete agreements, to ensure they comply with the law. The letter encourages Mortgage Connect to review and discontinue the use of any noncompete or other agreements that are not reasonably necessary and to notify relevant workers of their discontinuance.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/05/ftc-chairman-ferguson-issues-noncompete-warning-letter-mortgage-connect" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/legal-library/browse/warning-letters/mortgage-connect" target="_blank"&gt;Read the Letter&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Requires Divestiture of Ambulatory Surgery Centers in Ascension Health-AmSurg Deal&lt;/h4&gt;
&lt;p&gt;On June 2, 2026, the FTC announced that it would require Ascension Health Alliance (Ascension) to divest several surgery center facilities to complete its proposed $3.9 billion acquisition of AmSurg LLC. The divestiture covers each AmSurg facility in the relevant markets in which the FTC alleged that the proposed transaction would otherwise threaten competition: Nashville, Tenn.; Panama City, Fla.; Tulsa, Okla.; Waco, Texas; and Wichita, Kan. The FTC&amp;rsquo;s proposed consent order settles allegations that Ascension&amp;rsquo;s acquisition of AmSurg would limit competition for certain outpatient surgical services performed by gastroenterologists, ophthalmologists, and orthopedists across the Nashville, Panama City, Tulsa, Waco, and Wichita metro areas.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-requires-divestiture-ambulatory-surgery-centers-protect-patients-anticompetitive-effects" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/2510093ascensioncomplaint_0.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/2510093ascension_amsurgdecisionorder.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Announces Dissolution of Diversity Lab LLC Following an FTC Investigation&lt;/h4&gt;
&lt;p&gt;On June 5, 2026, the FTC announced that Diversity Lab LLC permanently ceased operations following an FTC investigation. The FTC alleged that Mansfield Certification required law firms to certify that they considered candidate pools made up of at least 30% individuals with particular characteristics. The FTC&amp;rsquo;s investigation sought information relevant to determining whether the Mansfield agreements were collusive in violation of Section 1 of the Sherman Act and Section 5 of the FTC Act.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/architect-law-firm-dei-programs-dissolves" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Finalizes Consent Order in Sevita Health&amp;rsquo;s Acquisition of BrightSpring Health Services&lt;/h4&gt;
&lt;p&gt;On June 10, 2026, the FTC finalized a consent order involving Sevita Health&amp;rsquo;s acquisition of BrightSpring Health Services Inc.&amp;rsquo;s community living business. The consent order requires Sevita to divest 128 intermediate care facilities (ICFs), which provide services to individuals with intellectual and developmental disabilities, and other assets such as day-training programs. The consent order requires Sevita to divest the facilities &amp;mdash; located in Indiana, Louisiana, and Texas &amp;mdash; to Dungarvin Group Inc., an experienced operator of ICFs. It also requires Sevita to assist Dungarvin in obtaining all licenses, permits, authorizations, or certifications related to, or necessary for, operating the divested facilities.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-finalizes-consent-order-sevita-brightspring-acquisition" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Sevita-Complaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/2510060C4829SevitaFinalOrder.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Finalizes Consent Order in 365 Retail Market LLC&amp;rsquo;s Acquisition of Cantaloupe Inc.&lt;/h4&gt;
&lt;p&gt;On June 17, 2026, the FTC finalized a consent order involving 365 Retail Markets LLC&amp;rsquo;s acquisition of Cantaloupe Inc. 365 Retail Markets was a provider of micromarket kiosks and Cantaloupe was a provider of micromarket kiosks and of point-of-sale software used in micromarket kiosks. The consent order settles FTC charges alleging that 365 Retail&amp;rsquo;s initial proposed acquisition of Cantaloupe would have eliminated head-to-head competition, likely driving up the price for micromarket kiosks and related software and services. The consent order requires 365 Retail to divest Cantaloupe&amp;rsquo;s micromarket kiosk business to Seaga Manufacturing Inc. The consent order also requires 365 Retail to provide its point-of-sale software to third-party competitors on non-discriminatory terms.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-approves-final-consent-order-micromarket-kiosks-deal" target="_blank"&gt;Read the Press Release&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/PEPCantaloupe-FinalComplaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/PEPCantaloupe-FinalOrder.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Requires Aurobindo Pharma Ltd. to Divest Generic Drug Products to Complete its Acquisition of Lannett Company Inc.&lt;/h4&gt;
&lt;p&gt;On June 18, 2026, the FTC announced a proposed consent order, which would resolve its antitrust concerns in Aurobindo Pharma Ltd.&amp;rsquo;s acquisition of Lannett Company Inc. The FTC alleged that the acquisition would limit competition in the markets for four generic drugs. The proposed consent order requires that Aurobindo divest the four generic products to Quagen Pharmaceuticals LLC. The four generic products to be divested under the consent order are:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;em&gt;Mycophenolate mofetil oral suspension&lt;/em&gt; &amp;mdash; an immunosuppressant prescribed to help prevent organ transplant rejection.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Niacin extended release tablets&lt;/em&gt; &amp;mdash; a drug used to manage cholesterol levels and to prevent or manage niacin, a B-complex vitamin, deficiency.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Pilocarpine tablets&lt;/em&gt; &amp;mdash; a drug used to treat dry mouth, often after radiation therapy for head and neck cancer or in patients with Sj&amp;ouml;gren&amp;rsquo;s syndrome, which is an autoimmune disease causing the immune system to attack moisture-producing glands.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Rabeprazole sodium delayed release tablets&lt;/em&gt; &amp;mdash; a proton pump inhibitor used to reduce stomach acid and indicated for the treatment of duodenal ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-takes-action-protect-americans-higher-drug-costs-aurobindo-lannett-deal" target="_blank"&gt;Read the Press Release&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/AurobindoComplaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;span&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;span&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Aurobindo-DecisionandOrder.pdf" target="_blank"&gt;&lt;/a&gt;&lt;/span&gt;&lt;a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Aurobindo-DecisionandOrder.pdf" target="_blank"&gt;Read the Consent Order&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC Files Amicus Brief in &lt;em&gt;CareFirst of Maryland v. Johnson &amp;amp; Johnson&lt;/em&gt;&lt;/h4&gt;
&lt;p&gt;On June 23, 2026, the FTC filed an amicus brief in an antitrust case before the United States Court of Appeals for the Fourth Circuit alleging that drug manufacturer Johnson &amp;amp; Johnson illegally maintained a monopoly through anticompetitive conduct. In the brief, the FTC urges that the Fourth Circuit reverse the district court and find that the district court erred in requiring willfulness to find monopolization liability.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/06/ftc-files-amicus-brief-protect-consumers-pharmaceutical-monopolies" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/CareFirstvJandJAmicusFINAL.pdf" target="_blank"&gt;Read the Amicus Brief&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;DOJ Cases and Proceedings&lt;/h3&gt;
&lt;h4&gt;DOJ Secures Guilty Plea From Former Air Force Member in Bid Rigging Schemes&lt;/h4&gt;
&lt;p&gt;On April 2, 2026, the DOJ Antitrust Division secured a guilty plea from Alan Hayward James, a former active-duty Master Sergeant of the U.S. Air Force. James pleaded guilty to conspiracy to commit bribery, wire fraud, and conspiracy to rig bids. He admitted to inflating the cost of information technology contracts by a total of $37 million and distributing the surplus to himself and co-conspirators.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/former-member-air-force-pleads-guilty-multi-year-bid-rigging-schemes-and-conspiracy-defraud" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Secures Prison Sentence From Defendant for Defrauding U.S. Military in Contract Bid Scam&lt;/h4&gt;
&lt;p&gt;On April 8, 2026, the DOJ Antitrust Division, working with the U.S. Attorney&amp;rsquo;s Office for the Southern District of Florida, secured a five-year prison sentence from the district judge in the sentencing of a defendant, Jasen Butler, convicted of defrauding the U.S. military in contract bid scams. The defendant, owner of Independent Marine Oil Services LLC, submitted fraudulent invoices to warships, receiving approximately $4.5 million in payments.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/fuel-executive-gets-five-year-prison-sentence-defrauding-us-military-contract-bid-scam" target="_blank"&gt;Read the Press Release&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Files Statement of Interest in California Fire Insurance Case &lt;/h4&gt;
&lt;p&gt;On May 4, 2026, the DOJ filed a statement of interest in &lt;em&gt;Ferrier v. State Farm Fire and Casualty Company&lt;/em&gt;, which is pending in the state Superior Court of Los Angeles County, California. This case was brought under California state antitrust law by 60 homeowners who lost their homes in the wildfires that occurred in southern California in January 2025. The homeowners allege that the defendants, 16 homeowner insurance companies, engaged in a group boycott by jointly conspiring to cancel the homeowners&amp;rsquo; fire insurance policies in the years leading up to the January 2025 fires. As a result, the homeowners claim, they were forced to obtain insurance from a state-run program that offers less protective coverage, resulting in higher out-of-pocket expenses for rebuilding their homes. The defendant insurers moved to dismiss the case, asserting that, under the &lt;em&gt;Noerr-Pennington&lt;/em&gt; doctrine, they are exempt from antitrust liability under both federal and California antitrust laws that protect petitioning and advocacy directed at government agencies. The statement of interest argues that the &lt;em&gt;Noerr-Pennington&lt;/em&gt; doctrine should not apply to the insurers&amp;rsquo; alleged group boycott of the homeowner policyholders, as the alleged boycott was separate and distinct from any government petitioning activity by the insurers.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-files-statement-interest-california-fire-insurance-case" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/media/1439391/dl" target="_blank"&gt;Read the Statement of Interest&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Announces Settlement With Agri Stats to Resolve Information Sharing Allegations &lt;/h4&gt;
&lt;p&gt;On May 7, 2026, the DOJ, along with several states, reached a proposed settlement with Agri Stats, Inc., to resolve allegations that Agri Stats&amp;rsquo; meat industry reports amounted to an impermissible exchange of information among competitors aimed at facilitating price fixing. Agri Stats is a data-sharing and consulting company engaged in the collection of prices, output, and costs from growers and processors in the broiler chicken, turkey, and pork industries. The settlement imposes a number of conduct restrictions on what data Agri Stats may collect and report, how that data must be aggregated and aged before it can be shared, who may purchase its reports and on what terms, and how compliance with all of these obligations will be monitored and enforced going forward.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-requires-agri-stats-end-exchange-competitively-sensitive-information" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="/en/perspectives/advisories/2026/05/agri-stats-settlement"&gt;Read Arnold &amp;amp; Porter&amp;rsquo;s Advisory&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Files Statement of Interest in &lt;em&gt;Corteva Agriscience LLC. v. Inari Agriculture Inc&lt;/em&gt; &lt;/h4&gt;
&lt;p&gt;On May 11, 2026, the DOJ filed a statement of interest in &lt;em&gt;Corteva Agriscience LLC, et al. v. Inari Agriculture Inc. et al.&lt;/em&gt; in the U.S. District Court for the District of Delaware. In the dispute, the plaintiff, Corteva, a large commercial seed and plant producer, sued Inari, a recent entry into the seed market, for patent infringement. As required by the Patent Act to receive valid patents for its seeds, Corteva deposited samples of its seeds to the American Type Culture Collection seed depository. Corteva alleged that Inari used this information to unlawfully recreate and iterate on Corteva&amp;rsquo;s seeds. The DOJ&amp;rsquo;s statement of interest takes the position that the Patent Act requires the publication of patented information, including the deposit of seeds, that accessing that information is permissible, and that seed deposits exist in part to allow for other companies to iterate and to innovate on patented seeds.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-files-statement-interest-highlighting-importance-enabling-competition-and" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1440271/dl?inline" target="_blank"&gt;Read the Statement of Interest&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Indicts Chinese Shipping Container Manufacturers and Executives in Price Fixing Conspiracy&lt;/h4&gt;
&lt;p&gt;On May 19, 2026, the DOJ announced that it had indicted four international shipping container manufacturers and seven of their executives for conspiring to restrict the output and fix the prices of standard unrefrigerated shipping containers. According to the indictment, the conspirators agreed to limit the number of shifts and hours that each production line for standard dry containers could run per day; install video surveillance to ensure all conspirators complied with the agreed-upon limitations; refrain from building new container factories; and establish a fund and mechanism to financially penalize any conspirator that violated their agreement. One executive, Vick Nam Hing Ma, was arrested in France, and his extradition to the United States is pending. The remaining six executives have not been arrested.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/four-worlds-largest-container-manufacturing-companies-and-seven-their-executives-indicted" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Arrests Defense Contractors for Bribery and Fraud Conspiracy &lt;/h4&gt;
&lt;p&gt;On May 20, 2026, the DOJ announced criminal charges against two defendants, Leonard Pick and Brian Kent, for bribery, major fraud against the United States, and conspiracy to commit bribery and major fraud. The indictment alleges that the defendants conspired to bribe a U.S. Army employee with approximately $1.25 million over five years and fraudulently inflated government contracting costs to include the U.S. Army employee&amp;rsquo;s bribe payments. The indictment further alleges that, from approximately September 2020, up to and including October 2022, defendant Kent further defrauded the government by inflating government contract costs to include approximately $680,000 in payments intended for and sent to Kent&amp;rsquo;s personal consulting business.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/two-defense-contractors-arrested-bribery-and-major-fraud-conspiracy-scheme-affecting" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Announces Commitment From Bayer to Modify Seed Loyalty Program&lt;/h4&gt;
&lt;p&gt;On May 20, 2026, the DOJ announced that Bayer CropScience LLC committed to maintaining changes it had previously made to its &amp;ldquo;Premier Performance Program&amp;rdquo; loyalty program. First, Bayer&amp;rsquo;s Premier Performance Program previously required independent seed companies to meet sales targets for both corn and soybean to achieve discounts under its loyalty program. Bayer committed to not reinstate the requirement for seven years. Second, the Premier Performance Program formerly included incentives that DOJ asserted could limit independent seed companies&amp;rsquo; willingness to license technology from Bayer&amp;rsquo;s competitors. In response to DOJ&amp;rsquo;s concerns, Bayer has committed to not reinstate these incentives, or any substantially similar incentive program, for seven years.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/antitrust-division-secures-seed-tying-and-loyalty-program-commitments-bayer" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Requires Taiheiyo Cement Corporation and CalPortland Company to Divest Assets in Acquisition of Ready-Mix Concrete Assets From Vulcan Materials Company&lt;/h4&gt;
&lt;p&gt;On May 21, 2026, the DOJ announced a proposed settlement with Taiheiyo Cement Corporation and its subsidiary CalPortland Company to divest three ready-mix concrete plants along with related assets to address antitrust concerns arising from CalPortland&amp;rsquo;s proposed $712 million acquisition of ready-mix concrete assets from Vulcan Materials Company. The proposed settlement resolves concerns that the transaction would likely cause higher prices, lower quality, and less favorable terms for buyers of ready-mix concrete in San Diego County, where it is used in home construction, commercial construction, and infrastructure projects.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-requires-taiheiyo-cement-corporation-and-calportland-company-divest" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/d9/2026-05/26-1783_us_v_taiheiyo_complaint.pdf" target="_blank"&gt;Read the Complaint&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/d9/2026-05/26-1783_us_v_taiheiyo_proposed_final_judgment.pdf" target="_blank"&gt;Read the Proposed Settlement&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Secures Guilty Plea in Healthcare-Related Bid Rigging Case&lt;/h4&gt;
&lt;p&gt;On June 2, 2026, the DOJ announced that it secured a guilty plea in its case against defendant Scott Srodes for rigging bids in the sale of shelving and storage products to the U.S. Air Force to service multiple healthcare and operations facilities. The defendant admitted to submitting collusive bids for multiple projects at healthcare facilities. According to the guilty plea, he and his co-conspirators exchanged pricing information prior to submitting them, at times instructing each other exactly what price to quote for certain projects. The guilty plea was the second in the DOJ&amp;rsquo;s ongoing investigation into bid rigging and fraud impacting U.S. military facilities.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/nevada-man-pleads-guilty-rigging-bids-healthcare-related-and-other-air-force-projects" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Issues Statement in Connection With the Closing of its Investigation of the Proposed Acquisition of Warner Bros. Discovery by Paramount Skydance&lt;/h4&gt;
&lt;p&gt;On June 12, 2026, the DOJ issued a statement in connection with the closing of its investigation of the proposed acquisition of Warner Bros. Discovery by Paramount Skydance. The DOJ stated that it does not intend to challenge the transaction as it is not likely to result in harm to competition, including with respect to: (1) streaming video on demand; (2) linear television; and (3) studio development, production, or distribution of films for theatrical release. The DOJ described these markets as highly dynamic and stated that the transaction&amp;rsquo;s impact would be to increase competition across the media and entertainment ecosystem. &lt;/p&gt;
&lt;p&gt;Regarding streaming video on demand, the DOJ noted that the acquisition was likely to increase competition because it would allow the post-merger company to more effectively coordinate its current offerings of Paramount+, discovery+, and HBO Max to compete with Netflix and the other largest streaming services. Regarding linear television, the DOJ concluded that the acquisition did not threaten competition because linear television already faces significant competition from streaming services for live programming such as sports rights and news. Regarding studio development, the DOJ concluded that non-legacy studios, including NEON, A24, and Blumhouse, demonstrate that the film development industry is dynamic, thus adequately incentivizing the post-acquisition company to continue to generate new content. &lt;/p&gt;
&lt;p&gt;Several State Attorneys General continue to have active investigations into the proposed acquisition under state and federal antitrust laws.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/statement-department-justice-antitrust-division-closing-its-investigation-merger-paramount" target="_blank"&gt;Read the Statement&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Secures Guilty Plea From Intelligence Community Contractor&lt;/h4&gt;
&lt;p&gt;On June 12, 2026, the DOJ announced that it secured the guilty plea of defendant David Duggin, a former intelligence community contractor, accused of soliciting and accepting illegal kickbacks. According to the guilty plea, the defendant and his co-conspirators used the defendant&amp;rsquo;s on-site access to sensitive information at an intelligence agency to illegally obtain government contracts for millions of dollars of hardware and software.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/former-intelligence-community-contractor-pleads-guilty-accepting-kickbacks" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Requires OhioHealth to Stop Using Healthcare Contract Terms That Raise Costs for Ohio Patients&lt;/h4&gt;
&lt;p&gt;On June 16, 2026, the DOJ announced a proposed settlement with OhioHealth Corporation, resolving its pending civil litigation. The DOJ alleged that OhioHealth used its market power to enact contractual restrictions that encumber or fully preclude insurers from offering budget-conscious health insurance plans or plan features. The proposed settlement seeks to void OhioHealth&amp;rsquo;s existing contract provisions that prohibit or deter insurers from offering innovative and budget-conscious health insurance plans or plan features and prevent OhioHealth from seeking or obtaining such contract provisions in the future and from penalizing health insurers offering budget-conscious health insurance plans. The proposed settlement would also appoint a compliance monitor to ensure compliance with the settlement&amp;rsquo;s conditions.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-requires-ohiohealth-stop-using-anticompetitive-healthcare-contract-terms" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;Supreme Court Issues Ruling in &lt;em&gt;Trump v. Slaughter&lt;/em&gt;, Allowing the President to Remove FTC Commissioners &lt;/h4&gt;
&lt;p&gt;On June 29, 2026, the Supreme Court issued its ruling in &lt;em&gt;Trump v. Slaughter&lt;/em&gt;, allowing President Trump to remove Former Commissioner Slaughter from her position as FTC commissioner and invalidating the statutory protections from removal for FTC commissioners. On March 18, 2025, President Trump ordered the dismissal of Democratic FTC commissioners Alvaro Bedoya and Rebecca Slaughter. Former Commissioner Slaughter sued in federal court in the District of Columbia, where she obtained an injunction on summary judgment ordering her reinstatement. The Supreme Court issued a stay of the injunction in September, before hearing oral arguments and ultimately allowing President Trump to remove Former Commissioner Slaughter. The Court held that statutory removal protections for executive officers violate the separation of powers, which requires the president to have the unfettered authority to remove executive officers from their positions at will.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/25-332_qn12.pdf" target="_blank"&gt;Read the Decision&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DOJ Announces Proposed Settlement With Egg Producers &lt;/h4&gt;
&lt;p&gt;On June 30, 2026, the DOJ announced proposed settlements in its case against Cal-Maine Foods Inc., Hickman&amp;rsquo;s Egg Ranch Inc., and Centrum Valley Holdings LLC. According to the DOJ, the defendants coordinated on egg spot market bidding decisions with the goal of raising daily price quotations for eggs. The proposed settlement prohibits the defendants from communicating with competitors regarding bidding prices or strategies.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-requires-egg-producers-end-coordinated-benchmark-manipulation" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1450281/dl?inline" target="_blank"&gt;Read the Complaint&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1450301/dl?inline" target="_blank"&gt;Read the Proposed Final Judgment (Cal-Maine)&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1450291/dl?inline" target="_blank"&gt;Read the Stipulation and Order (Cal-Maine)&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;FTC Policy&lt;/h3&gt;
&lt;h4&gt;FTC Supports Proposed Repeal of Certificate of Need Requirements&lt;/h4&gt;
&lt;p&gt;On April 2, 2026, the FTC released a letter of advocacy to Tennessee legislators, urging them not to repeal a Certificate of Public Advantage (COPA) that provides state regulatory oversight for Ballad Health. In it, they took the position that repealing the COPA in the absence of a competing healthcare system would enable a monopolist to exercise substantial market power unconstrained by state regulatory oversight.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/04/ftc-staff-warn-tennessee-legislature-risks-patients-if-ballad-health-copa-expires-support-proposed" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;DOJ Policy&lt;/h3&gt;
&lt;h4&gt;DOJ Approves Department of Energy Defense Production Act Consortium&amp;rsquo;s Updated Voluntary Agreement &lt;/h4&gt;
&lt;p&gt;On April 23, 2026, the DOJ approved the U.S. Department of Energy Defense Production Act Consortium&amp;rsquo;s Updated Voluntary Agreement. The agreement authorizes industry to enter into agreements necessary to meet national defense requirements. There is a limited antitrust defense available for actions taken to develop or carry out these approved agreements.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/antitrust-division-approves-department-energy-defense-production-act-consortiums-updated" target="_blank"&gt;Read the Press Release&lt;/a&gt;&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;Interagency Initiatives&lt;/h3&gt;
&lt;h4&gt;DOJ and FTC Extend Deadline for Public Comment on Guidance on Business Collaborations&lt;/h4&gt;
&lt;p&gt;On April 17, 2026, the DOJ and FTC extended the comment period deadline for their inquiry on consideration of guidance on collaborations among competitors from April 24, 2026 to May 21, 2026.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/doj-and-ftc-extend-deadline-public-comment-guidance-business-collaborations" target="_blank"&gt;Read the Press Release&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;FTC and DOJ Oppose ABA Law School Accreditation &lt;/h4&gt;
&lt;p&gt;On May 1, 2026, the FTC and DOJ released a letter, joined by the U.S. Attorney for the Middle District of Tennessee, urging the Tennessee Supreme Court to reduce its reliance on the American Bar Association (ABA) in determining which law schools provide sufficient education for their graduates to take the Tennessee bar examination. The FTC and DOJ took the position that solely allowing the ABA to handle accreditation drives up the cost of legal education, thereby limiting the supply of lawyers.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/news-events/news/press-releases/2026/05/ftc-urges-tennessee-supreme-court-oppose-abas-law-school-accreditation-monopoly" target="_blank"&gt;Read the FTC Press Release&amp;nbsp;&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/legal-library/browse/advocacy-filings/ftc-doj-comment-letter-supreme-court-tennessee-regarding-potential-regulatory-reforms-increase" target="_blank"&gt;Read the Letter&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;FTC Speeches and Statements&lt;/h3&gt;
&lt;h4&gt;Chief of Staff and Attorney Advisor for Competition to Commissioner Meador Daniel Graulich Delivers Remarks at the Informa Connect Antitrust West Coast Conference &lt;/h4&gt;
&lt;p&gt;On May 14, 2026, Daniel Graulich, Chief of Staff and Attorney Advisor for Competition to FTC Commissioner Meador, delivered a keynote address at the Informa Connect Antitrust West Coast Conference about a &amp;ldquo;functional approach&amp;rdquo; to antitrust enforcement and compliance. Graulich also drew a close parallel between the work of compliance teams and enforcement officials, arguing that both are fundamentally concerned with understanding the intent motivating business strategy through a holistic, fact-driven approach, and closed with four practical takeaways: that antitrust risk concentrates where market position, relationships, and strategic objectives intersect; that antitrust analysis looks to substance over form; that conduct is not evaluated in isolation but as part of an overall course of dealing; and that a contextual approach anchored in ordinary-course business documents is more effective for both compliance and enforcement.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/Daniel-Graulich-Informa-Keynote-Address.pdf" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;Commissioner Mark Meador Delivers Remarks Regarding Procedural Integrity in the Merger Review Process&lt;/h4&gt;
&lt;p&gt;On May 20, 2026, FTC Commissioner Mark Meador spoke at an FTC Bureau of Competition event about litigating the fix and the importance of procedural integrity in the merger review process. Meador argued that the prior administration&amp;rsquo;s deliberate policy of refusing to engage on remedies during the Hart-Scott-Rodino Act (HSR Act) review period produced damaging consequences: investigations became more drawn out, parties were incentivized to withhold remedy proposals for litigation, and agencies found themselves litigating transactions that had already been modified, without the investigative tools or time needed to evaluate the new terms. He traced the HSR Act&amp;rsquo;s origins to Congress&amp;rsquo; recognition that post-hoc merger challenges were too resource-intensive to effectively prevent anticompetitive harm, and argued that the premerger review process exists to allow remedies to be designed on a complete record before consummation.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/meador-litigate-the-fix.pdf" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;Commissioner Mark Meador Delivers Remarks Regarding the Role of Economics in Antitrust Adjudication &lt;/h4&gt;
&lt;p&gt;On June 11, 2026, FTC Commissioner Mark Meador delivered remarks on the role economics should play in antitrust adjudication. Meador argued that while economics is indispensable to antitrust, it is not a substitute for legal analysis or real-world evidence, and that theory does not displace facts, especially when models are constructed post hoc to support a litigation position. He identified three recurring judicial errors: first, the rote application of economic propositions from cases like &lt;em&gt;Verizon v. Trinko&lt;/em&gt; as categorical rules untethered from case-specific facts, which he called &amp;ldquo;Trinko creep&amp;rdquo;; second, courts give excessive weight to technical econometric models while discounting ordinary-course documents and intent evidence that more directly reveal what conduct was designed to achieve; and third, an excessive fixation on price and output metrics that can allow facially coercive conduct such as systematic deception or conditional dealing.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.ftc.gov/system/files/ftc_gov/pdf/The-Role-of-Economics-in-Antitrust-Adjudication-Meador.pdf" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;DOJ Speeches and Statements&lt;/h3&gt;
&lt;h4&gt;DAAG Beller Delivers Remarks at NAB Show Las Vegas&lt;/h4&gt;
&lt;p&gt;On April 20, 2026, DAAG Charlie Beller of the Antitrust Division spoke at the NAB Show in Las Vegas about federal antitrust enforcement in the evolving media landscape. He framed his remarks around two themes: first, that the DOJ&amp;rsquo;s enforcement priorities are rooted in federal interests and are designed to complement, not replace, state, private, and regulatory enforcement; and second, that technological change, including artificial intelligence (AI), requires cautious humility rather than reflexive action. On the media landscape, Beller noted that the competitive baseline for content distribution has changed fundamentally, with consumers now able to access content through broadcast, cable, satellite, streaming, and social media, and cautioned that increased choice does not eliminate the possibility of market power. On AI, Beller drew a parallel to the internet in its early years, noting that it expands tools available to creators and lowers barriers, but stressed that it is not a catch-all defense to competitive concerns and that assertions about future AI-driven competition must be grounded in evidence.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/deputy-assistant-attorney-general-g-charles-beller-delivers-remarks-nab-show-las-vegas" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;Acting AAG Assefi Delivers Remarks at Engelberg Center on Innovation Law &amp;amp; Policy at NYU School of Law&lt;/h4&gt;
&lt;p&gt;On May 7, 2026, Acting AAG Omeed Assefi spoke at the Engelberg Center on Innovation Law &amp;amp; Policy at New York University (NYU) School of Law about the Antitrust Division&amp;rsquo;s approach to merger enforcement. Assefi emphasized that the Antitrust Division&amp;rsquo;s approach is built on transparency, practicality, and precision, and noted that only 1% of HSR Act-reviewed mergers go to Second Request and the vast majority proceed without challenge. He outlined the Antitrust Division&amp;rsquo;s preference for structural remedies, citing three recent consent decrees, Constellation/Calpine, CMCO/Kito Crosby, and Reddy Ice/Arctic Glacier, as examples of targeted divestitures that resolved competitive concerns. Assefi also stressed the Antitrust Division&amp;rsquo;s willingness to litigate when necessary, pointing to past enforcement failures such as the Live Nation/Ticketmaster and Google/DoubleClick mergers as cautionary examples, and emphasized that transparent engagement from merging parties is expected throughout the review process.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/acting-assistant-attorney-general-omeed-assefi-delivers-remarks-engelberg-center" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;Acting DAAG for Criminal Enforcement Daniel Glad Delivers Remarks at the Antitrust West Coast Conference&lt;/h4&gt;
&lt;p&gt;On May 14, 2026, Acting DAAG for Criminal Enforcement Daniel Glad spoke at the Antitrust West Coast Conference in San Francisco about algorithmic collusion and criminal antitrust enforcement. Glad argued that software does not change the rule against collusion and that algorithmic tools cannot launder anticompetitive conduct, using the RealPage consent judgment, which required the company to stop using real-time competitor pricing data, as an illustration of how civil remedies target the specific mechanics of coordination rather than banning algorithmic pricing outright. He described how the Antitrust Division&amp;rsquo;s existing investigative architecture, including the Procurement Collusion Strike Force and the new Whistleblower Rewards Program (which recently issued its first-ever $1 million payment), is well-suited to detecting algorithmic cartel conduct because automated systems leave an even more extensive digital trail than traditional conspiracies. Glad also previewed three open questions the Antitrust Division is actively analyzing regarding AI-driven pricing: what constitutes an actionable agreement when pricing is mediated by a model, where criminal intent lies when humans delegate pricing decisions to AI, and whether the per se rule applies to large language model-generated pricing arrangements.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/acting-deputy-assistant-attorney-general-criminal-enforcement-daniel-gladd-delivers" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DAAG Nicole Sarrine Delivers Remarks at the Transparency Rising 2026 National Forum&lt;/h4&gt;
&lt;p&gt;On May 19, 2026, DAAG Nicole Sarrine spoke at the Transparency Rising 2026 National Forum in New Orleans about the Antitrust Division&amp;rsquo;s healthcare enforcement priorities. Sarrine described healthcare as a top enforcement priority given rising costs for consumers, employers, and government programs, and highlighted two recent cases challenging anticompetitive contracting practices by OhioHealth and NewYork-Presbyterian, which she argued use contract restrictions to prevent insurers from offering lower-cost health plan options. She also discussed the Antitrust Division&amp;rsquo;s December 2025 settlement resolving competitive concerns in UnitedHealth&amp;rsquo;s acquisition of Amedisys and the Antitrust Division&amp;rsquo;s monitoring of pharmacy benefit manager markets.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/deputy-assistant-attorney-general-nicole-sarrine-delivers-remarks-transparency-rising" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h4&gt;DAAG Nicole Sarrine Delivers Remarks at R-CALF USA 2026 Annual National Convention&lt;/h4&gt;
&lt;p&gt;On June 17, 2026, DAAG Nicole Sarrine spoke at the R-CALF USA 2026 Annual National Convention in Rapid City, South Dakota about &amp;ldquo;America First&amp;rdquo; antitrust enforcement in agricultural markets. Sarrine highlighted the Antitrust Division&amp;rsquo;s enforcement action against Agri Stats, which she described as a decades-long scheme through which major chicken, turkey, and pork processors shared confidential pricing data with each other, driving up food prices for consumers. On beef markets specifically, Sarrine confirmed that the DOJ&amp;rsquo;s investigation of the &amp;ldquo;Big Four&amp;rdquo; meatpackers is underway, and encouraged ranchers and cattlemen with relevant information to contact the Antitrust Division directly.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/deputy-assistant-attorney-general-nicole-sarrine-delivers-remarks-r-calf-usa-2026-annual" target="_blank"&gt;Read the Speech&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{FDB767F4-8964-4EDA-973D-C24EABEFC0C8}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/07/generative-ai-is-reshaping-the-defense-of-complex-litigation</link><a10:author><a10:name>David A. Kerschner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kerschner-david-a</a10:uri><a10:email>david.kerschner@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Melissa Weberman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/weberman-melissa</a10:uri><a10:email>melissa.weberman@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Angela M. Pelletier</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pelletier-angela-m</a10:uri><a10:email>angela.pelletier@arnoldporter.com</a10:email></a10:author><title>Generative AI Is Reshaping The Defense Of Complex Litigation</title><description>Defending against a lawsuit is expensive, document-intensive and increasingly complex. For in-house legal teams managing outside counsel and overseeing large-scale litigation &amp;mdash; including multidistrict litigation and mass torts &amp;mdash; the pressure to control costs while maintaining quality is constant.</description><pubDate>Wed, 08 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;span&gt;Defending against a lawsuit is expensive, document-intensive and increasingly complex. For in-house legal teams managing outside counsel and overseeing large-scale litigation &amp;mdash; including multidistrict litigation and mass torts &amp;mdash; the pressure to control costs while maintaining quality is constant. Generative AI is rapidly changing that calculus. Across the full lifecycle of a case, from early research and drafting through expert battles and trial preparation, AI tools are helping defense teams work faster, smarter, and more consistently. This article surveys three areas where these tools are making the greatest difference: legal research and drafting, fact witness development, and expert witness strategy. The tools and strategies discussed here don't work as a replacement for sophisticated counsel, but can be used to increase counsel's efficiency, freeing up bandwidth for more complex, strategic decision-making.&lt;/span&gt;</a10:content></item><item><guid isPermaLink="false">{78A90157-1C72-4AEA-89C3-4508F002374C}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/law360-interviews-ron-lee-on-ndaa-implications-for-government-contractors</link><title>Law360 Interviews Ron Lee on NDAA Implications for Government Contractors</title><description>Ron Lee, senior counsel in Arnold &amp;amp; Porter&amp;rsquo;s Government Contracts and National Security practices, was recently quoted in the&lt;em&gt; Law360&lt;/em&gt; article, &amp;ldquo;New Chinese Lobbying Law Raises Q&amp;rsquo;s For DOD Contractors,&amp;rdquo; covering how defense contractors are navigating implementation of a provision of the National Defense Authorization Act for Fiscal Year 2025 that prohibits the Secretary of Defense from contracting with companies that contract with a firm that provides lobbying activities for companies on the Department of Defense&amp;rsquo;s list of Chinese military companies operating in the United States.</description><pubDate>Tue, 07 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Ron Lee, senior counsel in Arnold &amp;amp; Porter&amp;rsquo;s Government Contracts and National Security practices, was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;New Chinese Lobbying Law Raises Q&amp;rsquo;s For DOD Contractors,&amp;rdquo; covering how defense contractors are navigating implementation of a provision of the National Defense Authorization Act for Fiscal Year 2025 that prohibits the Secretary of Defense from contracting with companies that contract with a firm that provides lobbying activities for companies on the Department of Defense&amp;rsquo;s list of Chinese military companies operating in the United States.&lt;/p&gt;
&lt;p&gt;Ron highlighted that, because of the NDAA&amp;rsquo;s broad definition of lobby activities, the law inevitably affects a very wide range of defense contractors. &lt;/p&gt;
&lt;p&gt;&amp;ldquo;I can&amp;rsquo;t think of any group of DOD contractors that could just confidently say, well, we don&amp;rsquo;t really need to worry about this, because we know exactly who all the other clients and activities of all the entities that you contract with,&amp;rdquo; Ron said. &amp;ldquo;So, it&amp;rsquo;s something that I think is and probably should be occupying the attention of pretty much the entire DOD contracting community.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;He also emphasized that the process of ensuring contracts comply with the law will be ongoing, as DOD continues to update its 1260H list with additional covered companies. &lt;/p&gt;
&lt;p&gt;&amp;ldquo;[Defense contractors] have to look at all their other business partners, the people that they&amp;rsquo;re contracting with ... the law firms, the consulting firms, the lobbying firm, and so on, and those firms&amp;rsquo; customers [and] clients could be changing all the time,&amp;rdquo; Ron said. &amp;ldquo;So, the point I&amp;rsquo;m trying to make here is that it&amp;rsquo;s a very much dynamic and constantly changing situation.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2496855/new-chinese-lobbying-law-raises-q-s-for-dod-contractors-" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F4E20F71-FFBE-4751-AAC6-0C9DC4FF9160}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/prominent-tech-litigator-sunita-bali-joins-arnold-porter-in-san-francisco</link><title>Prominent Tech Litigator Sunita Bali Joins Arnold &amp; Porter in San Francisco, Continuing West Coast Expansion</title><description>&lt;strong&gt;SAN FRANCISCO, July 7, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Sunita Bali has joined the firm&amp;rsquo;s Complex Litigation practice as a partner. Sunita will be resident in the firm&amp;rsquo;s San Francisco office.</description><pubDate>Tue, 07 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;SAN FRANCISCO, July 7, 2026 &lt;/strong&gt;&amp;mdash; Arnold &amp;amp; Porter announced today that Sunita Bali has joined the firm&amp;rsquo;s Complex Litigation practice as a partner. Sunita will be resident in the firm&amp;rsquo;s San Francisco office. Her arrival builds on the firm&amp;rsquo;s ongoing West Coast strategic growth and follows several other additions in Los Angeles, San Francisco, and Seattle this year.&lt;/p&gt;
&lt;p&gt;Ken Chernof, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Complex Litigation group, said: &amp;ldquo;Sunita is an exceptional litigator whose command of privacy law, consumer class actions, and content moderation disputes makes her an outstanding addition to our technology industry practice. She brings sophisticated experience in some of the most consequential areas of technology litigation, and we are delighted to welcome her.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Jonathan Hughes, head of Arnold &amp;amp; Porter&amp;rsquo;s San Francisco and Silicon Valley offices, added: &amp;ldquo;Sunita&amp;rsquo;s arrival not only continues to further strengthen our West Coast litigation platform, but her depth in privacy and technology litigation and her track record of success will be a tremendous asset to our clients and team across the U.S.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;A seasoned commercial litigator, Sunita represents technology, retail, and other clients in complex privacy, consumer class-action, and other commercial litigation disputes. She advises clients on compliance with privacy and consumer protection laws, particularly those that regulate the collection and use of biometric and other sensitive data. Sunita regularly defends large, high-stakes privacy and consumer class-action cases brought under the federal Wiretap Act, the Stored Communications Act, the Illinois Biometric Information Privacy Act, the California Invasion of Privacy Act, and California&amp;rsquo;s consumer protection laws. She also has well over a decade of experience litigating and advising clients on content moderation issues and has represented some of the world&amp;rsquo;s largest companies in high-profile cases implicating Section 230 of the Communications Decency Act and the First Amendment.&lt;/p&gt;
&lt;p&gt;In joining the firm, Sunita said: &amp;ldquo;Some of today&amp;rsquo;s most consequential legal battles in the technology sector involve the application of complex privacy and consumer protection laws to novel and developing technologies. Arnold &amp;amp; Porter&amp;rsquo;s multidisciplinary platform, deep bench of practitioners, and global reputation make it an ideal fit for my practice.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Sunita earned her J.D. from the University of Southern California Gould School of Law and her B.A. from Occidental College.&amp;nbsp; &lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C2C71FA3-5FAE-46ED-88A6-B98F5F8CD5FB}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/mark-epley-talks-federal-tax-developments-with-law360</link><title>Mark Epley Talks Federal Tax Developments with Law360</title><description>Arnold &amp;amp; Porter Legislative &amp;amp; Public Policy partner Mark Epley was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Top Federal Tax Policies Of 2026: Midyear Report,&amp;rdquo; discussing the most consequential developments in federal tax policy from the first half of 2026.&amp;nbsp;</description><pubDate>Tue, 07 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Legislative &amp;amp; Public Policy partner Mark Epley was recently quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Top Federal Tax Policies Of 2026: Midyear Report,&amp;rdquo; discussing the most consequential developments in federal tax policy from the first half of 2026. &lt;/p&gt;
&lt;p&gt;Regarding proposals to make administrative changes to the Internal Revenue Service, Mark highlighted the importance of bipartisan agreement in producing lasting improvements.  &lt;/p&gt;
&lt;p&gt;&amp;ldquo;In the absence of reconciliation, the only way to do tax legislation &amp;mdash; or anything for that matter &amp;mdash; is through genuine, bona fide, bipartisan agreement, and, as it happens, those are sort of the most durable changes,&amp;rdquo; he said. &amp;ldquo;Improving tax administration is something around which the two parties have been able to find consensus.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;As lawmakers work on IRS funding legislation ahead of the start of the fiscal year in September, Mark also noted that a sufficiently funded IRS is essential, yet often difficult to achieve.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;This has been a challenge for well over 10 years,&amp;rdquo; he said. &amp;ldquo;No spending bill can be passed without bipartisan consensus, which means that you need to get bipartisan consensus around the right level of funding for the IRS.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/tax-authority/articles/2487576?" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required). &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9F603CF1-36BA-438E-9B97-9FED21FF7A7F}</guid><link>https://www.linkedin.com/posts/mehrinmasudelias_i-know-its-over-a-month-away-but-i-had-share-7462131230612865024-JRng/?utm_source=social_share_send&amp;utm_medium=ios_app&amp;rcm=ACoAAAKOK_IBrDL9HRj-Cks7TZjHfy9obKlQZn0</link><author>mir.elias@arnoldporter.com</author><title>Legal Strategies for Academic-Industry Research Collaborations</title><pubDate>Tue, 07 Jul 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{56F34AC9-FD0A-40BE-A0B4-92635765BA1A}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/07/arnold-porters-trial-school-spotlighted-in-the-national-law-journal</link><title>Arnold &amp; Porter’s Trial School Spotlighted in The National Law Journal</title><description>&lt;em&gt;The National Law Journal &lt;/em&gt;recently featured Arnold &amp;amp; Porter&amp;rsquo;s annual trial school in the article, &amp;ldquo;AI-Proof Work: How One Big Law firm's Trial School Trains Associates,&amp;rdquo; which highlights the firm's long-standing commitment to and continued investment in preparing associates for courtroom training through immersive, hands-on training at a time when artificial intelligence is transforming many aspects of legal practice.</description><pubDate>Thu, 02 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;em&gt;The National Law Journal&lt;/em&gt; recently featured Arnold &amp;amp; Porter&amp;rsquo;s annual trial school in the article, &amp;ldquo;AI-Proof Work: How One Big Law firm's Trial School Trains Associates,&amp;rdquo; which highlights the firm's long-standing commitment to and continued investment in preparing associates for courtroom training through immersive, hands-on training at a time when artificial intelligence is transforming many aspects of legal practice.&lt;/p&gt;
&lt;p&gt;The article notes that more than 50 associates, partners, counsel, and administrative professionals participated in this year&amp;rsquo;s program, which combined workshops with five simultaneous mock trials led by more than 30 partners and counsel serving as coaches, judges, and witnesses.&lt;/p&gt;
&lt;p&gt;The program is directed by partners Jim Herschlein, co-chair of the firm's Litigation practice, and Pamela Yates, a partner in the Products Liability Litigation practice, who also served as a coach. Jim has led this program for over a decade, and in the article, Jim emphasized the firm's commitment to associate development. "It&amp;rsquo;s part of our obligation to help develop the skills of our associates,&amp;rdquo; he said. &amp;ldquo;This program really gives us the chance to help them learn and advance their careers.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Ken Chernof, co-chair of the firm&amp;rsquo;s Litigation practice, explained why trial skills development remains an essential area of investment despite advances in AI. &amp;ldquo;AI may replace some aspects of [the litigation] practice, but it is not going to replace stand-up trial work,&amp;rdquo; he said. &amp;ldquo;The associates that we have and the recruits that we&amp;rsquo;re talking to want to know that they&amp;rsquo;re going to be trained in the thing that AI can&amp;rsquo;t train them in, which is standing up in court with a jury in the box, with a judge on the bench, and being able to cross-examine a witness effectively.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;On the firm&amp;rsquo;s commitment to organizing the trial school in-house instead of outsourcing to an external program, Ken commented: &amp;ldquo;[It] gives our partners a chance to see our associates in action; our associates learn from the partners they work with. It&amp;rsquo;s a great kind of dynamic that produces, we think, even better results.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The article also highlights the significant commitment of the firm's trial lawyers to the program. As a former Arnold &amp;amp; Porter associate who participated in the trial school, partner Diana Sterk served as a coach to one of the trial teams this year and spoke on the value of the experience for young attorneys, noting that it can be the &amp;ldquo;first time for a lot of associates to really understand all of the pieces that go into trial and to be thinking about it more holistically.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law.com/nationallawjournal/2026/07/01/ai-proof-work-how-one-big-law-firms-trial-school-trains-associates/" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;
&lt;div style="padding:56.25% 0 0 0;position:relative;"&gt;&lt;iframe src="https://player.vimeo.com/video/1206568384?dnt=1&amp;amp;h=3c93f4d034&amp;amp;badge=0&amp;amp;autopause=0&amp;amp;player_id=0&amp;amp;app_id=58479" frameborder="0" allow="autoplay; fullscreen; picture-in-picture; clipboard-write; encrypted-media; web-share" referrerpolicy="strict-origin-when-cross-origin" style="position:absolute;top:0;left:0;width:100%;height:100%;" title="Trial School Photo Gallery"&gt;&lt;/iframe&gt;&lt;/div&gt;</a10:content></item><item><guid isPermaLink="false">{385FA727-1BDD-4A64-92C0-7025B21E4EDD}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/07/china-imposes-export-control-and-government-procurement-restrictions-on-designated-us-companies</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bobby McMillin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mcmillin-bobby</a10:uri><a10:email>bobby.mcmillin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sonia Tabriz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabriz-sonia</a10:uri><a10:email>sonia.tabriz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Claire E. Reade</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/reade-claire</a10:uri><a10:email>claire.reade@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Chuqiao Yu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/y/yu-chuqiao</a10:uri><a10:email>chuqiao.yu@cn.arnoldporter.com</a10:email></a10:author><title>China Imposes Export Control and Government Procurement Restrictions on Designated U.S. Companies</title><description>On June 22, 2026, China&amp;rsquo;s Ministry of Commerce (MOFCOM) and Ministry of Finance (MOF) both announced restrictive measures targeting a total of 56 U.S. entities, likely in response to the U.S. Department of Defense&amp;rsquo;s (DoD) recent expansion of its list of &amp;ldquo;Chinese military companies,&amp;rdquo; also known as the &amp;ldquo;1260H List.&amp;rdquo; This Advisory provides an overview of the June 22 announcements, and summarizes the key prohibitions and latest developments.</description><pubDate>Thu, 02 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 22, 2026, China&amp;rsquo;s Ministry of Commerce (MOFCOM) and Ministry of Finance (MOF) both announced restrictive measures targeting a total of 56 U.S. entities, likely in response to the U.S. Department of Defense&amp;rsquo;s (DoD) recent expansion of its list of &amp;ldquo;Chinese military companies,&amp;rdquo; also known as the &amp;ldquo;1260H List.&amp;rdquo; This Advisory provides an overview of the June 22 announcements, and summarizes the key prohibitions and latest developments.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;On June 8, 2026, the U.S. DoD released an updated version of the 1260H List, which added several prominent Chinese companies, including Alibaba, Baidu, and Tencent. As discussed in our &lt;a href="/en/perspectives/advisories/2026/06/national-security-controls-and-the-life-sciences-sector"&gt;June 2026 Advisory&lt;/a&gt;, inclusion on the 1260H List is significant because it may lead to a company&amp;rsquo;s designation as a &amp;ldquo;biotechnology company of concern&amp;rdquo; (BCC) under the BIOSECURE Act, which could trigger additional restrictions on contracting with federal agencies and counterparties, as well as on the use of such companies&amp;rsquo; biotechnology equipment or services. In addition, the U.S. DoD is prohibited from contracting directly with entities identified as Chinese military companies, and will be prohibited effective June 30, 2027 from purchasing any goods or services produced or developed by an entity on the 1260H list, among other restrictions. These restrictions apply both to the designated Chinese military companies as well as entities subject to the control of a listed entity.&lt;/p&gt;
&lt;h2&gt;The MOFCOM Announcement: Export Controls on 10 Companies&lt;/h2&gt;
&lt;p&gt;In its&lt;a rel="noopener noreferrer" href="https://www.mofcom.gov.cn/zwgk/zcfb/art/2026/art_dfa9cc5c1e004d7fbb86f83d249e7986.html?mc_cid=bf45a4f936&amp;amp;mc_eid=a833d46eef" target="_blank"&gt; June 22 announcement&lt;/a&gt;, MOFCOM added 10 U.S. companies to China&amp;rsquo;s Export Control List pursuant to the Export Control Law (中华人民共和国出口管制法) and the Regulations on the Export Control of Dual-Use Items (中华人民共和国两用物项出口管制条例),[[N: See &lt;a rel="noopener noreferrer" href="https://www.mofcom.gov.cn/zwgk/zcfb/art/2026/art_dfa9cc5c1e004d7fbb86f83d249e7986.html?mc_cid=bf45a4f936&amp;amp;mc_eid=a833d46eef" target="_blank"&gt;https://www.mofcom.gov.cn/zwgk/zcfb/art/2026/art_dfa9cc5c1e004d7fbb86f83d249e7986.html?mc_cid=bf45a4f936&amp;amp;mc_eid=a833d46eef&lt;/a&gt;.]] imposing the following restrictions:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Prohibiting the export, transfer, or supply of dual-use items to the listed entities, including banning any organizations or individuals, in any country or region, from providing China-origin dual-use items to the listed entities, and requiring the immediate cessation of any such ongoing export activities,&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Requiring export operators to apply to MOFCOM for approval in exceptional circumstances where such exports are deemed necessary.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The 10 listed entities are primarily concentrated in the defense, aerospace, unmanned systems, and rare earth sectors. They include Red Cat Holdings, Teal Drones, and USA Rare Earth, among others.&lt;/p&gt;
&lt;h2&gt;The MOF Announcement: Government Procurement Restrictions on 46 Entities&lt;/h2&gt;
&lt;p&gt;In a &lt;a rel="noopener noreferrer" href="https://gks.mof.gov.cn/guizhangzhidu/202606/t20260622_3991936.htm" target="_blank"&gt;separate June 22 announcement&lt;/a&gt;, MOF prohibited the procurement of products manufactured by 46 U.S. entities. This restriction does not apply to U.S.-funded enterprises operating in China.&lt;/p&gt;
&lt;p&gt;The 46 entities consist of defense contractors and their affiliates, including major defense manufacturers such as Lockheed Martin, Boeing Defense, and Space &amp;amp; Security, as well as defense technology companies, such as Shield AI. Several of these companies, such as certain Lockheed Martin affiliates and the Raytheon/Lockheed Martin Javelin joint venture, had previously been added to China&amp;rsquo;s &lt;a rel="noopener noreferrer" href="https://www.mofcom.gov.cn/cms_files/filemanager/policySummary/viewcore_02fa53a498c24b5e8070255b0928c6bf.html" target="_blank"&gt;Unreliable Entity List&lt;/a&gt; (不可靠实体清单) in connection with arms sales to Taiwan. &lt;/p&gt;
&lt;p&gt;While the latest U.S. government expansion of the 1260H List added a number of Chinese biotech and consumer tech companies, the announcements by MOFCOM and MOF did not follow suit.  Their response has focused more narrowly on sectors such as defense, where U.S.-China trade was already minimal, and on U.S. rare earths producers, who have been working to insulate their supply chains from China. This may signal China&amp;rsquo;s view that avoiding significant escalation of political tensions with the United States at present is more helpful to China&amp;rsquo;s overall goals.&lt;/p&gt;
&lt;h2&gt;Legal Challenges to Latest U.S. 1260H Designations&lt;/h2&gt;
&lt;p&gt;At least two companies named on the United States&amp;rsquo; updated 1260H List have initiated legal challenges to their designation as Chinese military companies as of the publication of this Advisory:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;WuXi AppTec, a well-known life sciences and pharmaceutical services company, in the U.S. District Court for the District of Columbia on June 11, 2026, asserting that its designation lacks factual and legal basis and seeking removal from the list.[[N: See &lt;a rel="noopener noreferrer" href="https://storage.courtlistener.com/recap/gov.uscourts.dcd.293402/gov.uscourts.dcd.293402.1.0.pdf" target="_blank"&gt;https://storage.courtlistener.com/recap/gov.uscourts.dcd.293402/gov.uscourts.dcd.293402.1.0.pdf&lt;/a&gt;.]]&lt;/li&gt;
    &lt;li&gt;Alibaba, a company with significant consumer tech operations, in the U.S. District Court for the Northern District of California on June 23, 2026, similarly asserting that its designation has &amp;ldquo;no basis in fact or law,&amp;rdquo; and seeking removal from the list.[[N: See &lt;a rel="noopener noreferrer" href="https://storage.courtlistener.com/recap/gov.uscourts.cand.472746/gov.uscourts.cand.472746.1.0.pdf" target="_blank"&gt;https://storage.courtlistener.com/recap/gov.uscourts.cand.472746/gov.uscourts.cand.472746.1.0.pdf&lt;/a&gt;.]]&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;From publicly available information, no legal challenges have been mounted to the new Chinese restrictions at this time.&lt;/p&gt;
&lt;p&gt;If you have any questions about the content discussed in this Advisory or would like more information, including about compliance with applicable U.S. law or the path to challenge designation as a Chinese military company, please reach out to one of the authors or your existing Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{6BBA81EA-5462-4E92-A978-CA9D178EE5ED}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/07/daily-journal-names-dipanwita-deb-amar-and-david-reis-to-2026-top-labor-employment-lawyers-list</link><title>Daily Journal Names Dipanwita Deb Amar and David Reis to 2026 ‘Top Labor &amp; Employment Lawyers’ List</title><description>Arnold &amp;amp; Porter partners Dipanwita Deb Amar and David Reis were named to the &lt;em&gt;Daily Journal&lt;/em&gt;'s 2026 list of "Top Labor &amp;amp; Employment Lawyers." The annual supplement profiles California's "top labor and employment attorneys specializing in litigation, PAGA matters, unlawful terminations, and workplace investigations."</description><pubDate>Wed, 01 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partners Dipanwita Deb Amar and David Reis were named to the &lt;em&gt;Daily Journal&lt;/em&gt;'s 2026 list of "Top Labor &amp;amp; Employment Lawyers." The annual supplement profiles California's "top labor and employment attorneys specializing in litigation, PAGA matters, unlawful terminations, and workplace investigations."&lt;/p&gt;
&lt;p&gt;The &lt;em&gt;Daily Journal&lt;/em&gt;'s profile of Dipanwita highlighted her nearly three decades of labor and employment practice and her recent success securing a unanimous jury verdict for Cynosure in a trade secrets and restrictive covenant dispute. Following post-trial rulings, the judgment exceeded $35 million. The profile also recognized Dipanwita's representation of clients in high-profile employment litigation and noted her experience handling discrimination, whistleblower, and agency matters nationwide.&lt;/p&gt;
&lt;p&gt;David, co-chair of the firm's Labor &amp;amp; Employment practice, was recognized for his extensive trial and arbitration experience representing employers in complex employment disputes. The profile highlighted his successful defense of Hint, Inc. in a closely watched employment arbitration involving claims brought by the company's former founder-executives, as well as his work securing favorable outcomes in significant FEHA retaliation and PAGA litigation.&lt;/p&gt;
&lt;p&gt;Dipanwita and David have been consistently recognized as top labor and employment lawyers by the &lt;em&gt;Daily Journal&lt;/em&gt;, with Dipanwita being named 13 times since 2012 and David being named 16 times since 2010.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{51AE216A-5DBA-46D7-B384-5E981A19F45B}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/artificial-intelligence-privilege-and-work-product-emerging-risks-in-the-life-sciences-industry</link><a10:author><a10:name>Brian P. Dunphy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dunphy-brian-p</a10:uri><a10:email>brian.dunphy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Samuel Lonergan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lonergan-samuel</a10:uri><a10:email>samuel.lonergan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Rebecca Maller-Stein</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/maller-stein-rebecca</a10:uri><a10:email>rebecca.maller-stein@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Carmela T. Romeo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/romeo-carmela-t</a10:uri><a10:email>carmela.romeo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tess Saperstein</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/saperstein-tess</a10:uri><a10:email>tess.saperstein@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Melissa Weberman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/weberman-melissa</a10:uri><a10:email>melissa.weberman@arnoldporter.com</a10:email></a10:author><title>Artificial Intelligence, Privilege, and Work Product: Emerging Risks in the Life Sciences Industry</title><description>As artificial intelligence (AI) use has become prevalent in nearly every stage of litigation, including pre-litigation efforts, courts and litigants alike have encountered challenges applying longstanding doctrine to new technology. Recent decisions indicate that courts disagree on whether communications with generative AI tools are more like disclosures to a third party or more like the use of traditional word-processing tools.</description><pubDate>Wed, 01 Jul 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Introduction&lt;/h2&gt;
&lt;p&gt;As artificial intelligence (AI) use has become prevalent in nearly every stage of litigation, including pre-litigation efforts, courts and litigants alike have encountered challenges applying longstanding doctrine to new technology. Recent decisions indicate that courts disagree on whether communications with generative AI tools are more like disclosures to a third party or more like the use of  traditional word-processing tools. In particular, courts are grappling with whether disclosure of sensitive information to publicly available AI platforms constitutes disclosure to a &amp;ldquo;third party&amp;rdquo; sufficient to waive attorney-client privilege or undermine attorney work-product protection.&lt;/p&gt;
&lt;p&gt;These developments are especially significant for life sciences companies, which routinely handle highly confidential and proprietary information, including intellectual property, trade secrets, clinical research, regulatory strategy, and commercially sensitive data. Because legal advice in the life sciences sector is often deeply intertwined with technical and scientific information, the use of AI tools in connection with legal and business decision-making presents heightened discovery and confidentiality risks.&lt;/p&gt;
&lt;p&gt;Recent decisions from courts across the country show courts approaching these questions differently, with results that often track the particular protection at issue, attorney-client privilege, or work product.&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;United States v. Heppner&lt;/em&gt;: AI Communications and the Limits of Attorney-Client Privilege&lt;/h2&gt;
&lt;p&gt;&lt;a href="/en/perspectives/blogs/enforcement-edge/2026/02/the-attorney-client-machine-relationship-when-ai-use-jeopardizes-privilege"&gt;As we have discussed&lt;/a&gt;, in &lt;em&gt;United States v. Heppner&lt;/em&gt;, 820 F. Supp. 3d 292 (S.D.N.Y. 2026), Judge Rakoff addressed whether a criminal defendant&amp;rsquo;s use of a generative AI platform to develop defense strategies could be protected by either the attorney-client privilege or the work-product doctrine. &lt;/p&gt;
&lt;p&gt;After learning he was the target of a criminal investigation, Heppner used the publicly available version of generative AI platform Claude to prepare reports that outlined a potential defense strategy. The government later seized those materials while executing a search warrant. Through (human, retained) counsel, Heppner argued that the materials were privileged because Heppner (1) inputted into Claude information that he had learned from counsel, among other things; (2) created the AI documents for the purpose of speaking with counsel to obtain legal advice; and (3) shared the contents of the AI documents with counsel. &lt;/p&gt;
&lt;p&gt;The court rejected Heppner&amp;rsquo;s attorney-client privilege arguments, concluding that the AI documents &amp;ldquo;lack at least two, if not all three, elements of the attorney-client privilege.&amp;rdquo; Id. at 296. The court emphasized that communications with the publicly available version of Claude are not communications with an attorney, are not confidential, and were not made for the purpose of obtaining legal advice from a lawyer. Although the last element was a &amp;ldquo;closer call&amp;rdquo; because, as defense counsel argued, Heppner communicated with Claude for the &amp;ldquo;express purpose of talking to counsel,&amp;rdquo; defense counsel nonetheless conceded that these communications were not &amp;ldquo;at the suggestion or direction of counsel.&amp;rdquo; Id. at 297. Had that been the case, the court noted that Claude &amp;ldquo;might arguably be said to have functioned in a manner akin to a highly trained professional who may act as a lawyer&amp;rsquo;s agent within the protection of the attorney-client privilege.&amp;rdquo; Id. However, the communications were made of Heppner&amp;rsquo;s own volition, and Claude itself &amp;ldquo;disclaims providing legal advice.&amp;rdquo; Id. Accordingly, the communications were not privileged at the time they took place and could not &amp;ldquo;somehow [be] alchemically changed into privileged ones upon being shared with counsel.&amp;rdquo; Id. Moreover, the court held that even if the communications that Heppner provided to Claude were privileged, Heppner waived any such privilege by sharing the information with the publicly available version of Claude and Anthropic &amp;ldquo;just as if he had shared it with any other third party.&amp;rdquo; Id. at 297 n.3. Indeed, the court noted that Claude and Anthropic&amp;rsquo;s &amp;ldquo;written privacy policy to which users of Claude consent provides that Anthropic collects data on both users&amp;rsquo; &amp;lsquo;inputs&amp;rsquo; and Claude&amp;rsquo;s &amp;lsquo;outputs,&amp;rsquo; that it uses such data to &amp;lsquo;train&amp;rsquo; Claude, and that Anthropic reserves the right to disclose such data to a host of &amp;lsquo;third parties,&amp;rsquo; including &amp;lsquo;governmental regulatory authorities.&amp;rsquo;&amp;rdquo; Id. at 296. Therefore, Heppner lacked a reasonable expectation that his inputs would not be shared with other third parties. Id. at 297 n.3.&lt;/p&gt;
&lt;p&gt;The court further concluded that the work-product doctrine did not apply because, even if the AI reports had been prepared in anticipation of litigation, they were not prepared at the behest of counsel and did not reflect defense counsel&amp;rsquo;s strategy. Id. at 298. &lt;/p&gt;
&lt;p&gt;&lt;em&gt;Heppner&lt;/em&gt; reflects a strict, fact-bound application of the attorney-client privilege to communications with publicly available generative AI. If adopted more broadly, this reasoning could have substantial implications for clients who use publicly available AI tools in connection with legal matters, even where external legal counsel has been retained or in-house legal counsel has been involved in a brewing dispute. In particular, company employees need to be cautious not to conduct ostensibly legal research using publicly available AI tools without the direction or instruction of counsel. Such work is unlikely to be privileged in the first place because it does not involve communication with an attorney, and to the extent an employee inputs advice already received from counsel, that disclosure risks waiving the privilege the advice would otherwise enjoy. &lt;/p&gt;
&lt;h2&gt;AI and The Attorney Work Product Protection&lt;/h2&gt;
&lt;p&gt;While &lt;em&gt;Heppner&lt;/em&gt;, one of the first in-depth judicial opinions addressing the interplay between the use of AI and the attorney-client privilege, applied those protections strictly, other courts have taken relatively expansive views of the attorney work product doctrine and AI-assisted litigation preparation. In both &lt;em&gt;Warner v. Gilbarco, Inc.&lt;/em&gt;, 820 F. Supp. 3d 629 (E.D. Mich. 2026), and &lt;em&gt;Morgan v. V2X, Inc.&lt;/em&gt;, No. 25-CV-01991-SKC-MDB, 2026 WL 864223 (D. Colo. Mar. 30, 2026), the courts concluded that &lt;em&gt;pro se&lt;/em&gt; plaintiffs could invoke the work-product doctrine with respect to materials generated through the use of publicly available AI tools. &lt;/p&gt;
&lt;p&gt;Although aspects of the analyses in &lt;em&gt;Morgan&lt;/em&gt; and &lt;em&gt;Warner&lt;/em&gt; may be unique to &lt;em&gt;pro se&lt;/em&gt; litigants and/or reflective of how one may waive the attorney-client privilege versus the attorney work product privilege, the courts&amp;rsquo; expansive treatment of the parties&amp;rsquo; expectation of privacy when interacting with AI is notable. In &lt;em&gt;Heppner&lt;/em&gt;, the court stated that &amp;ldquo;in light of Anthropic&amp;rsquo;s privacy policy,&amp;rdquo; the defendant &amp;ldquo;had no reasonable expectation that the inputs would not be shared with other third parties.&amp;rdquo; &lt;em&gt;Heppner&lt;/em&gt;, 820 F. Supp. 3d at 297 n.3. By contrast, in &lt;em&gt;Morgan&lt;/em&gt;, the court stated it was &amp;ldquo;entirely reasonable for a person to expect some privacy and confidentiality when interacting with these tools, even though they understand a third party is behind the tool collecting and storing their information.&amp;rdquo; 2026 WL 864223, at *5. Similarly, in &lt;em&gt;Warner&lt;/em&gt;, the court noted that &amp;ldquo;the work-product waiver has to be a waiver to &lt;em&gt;an adversary&lt;/em&gt; or in a way likely to get into an adversary&amp;rsquo;s hand &amp;hellip; And ChatGPT (and other generative AI programs) are &lt;em&gt;tools&lt;/em&gt;, &lt;em&gt;not persons&lt;/em&gt;, even if they may have administrators somewhere in the background.&amp;rdquo; 820 F. Supp. 3d at 636-37. As such, &lt;em&gt;Morgan&lt;/em&gt; and &lt;em&gt;Warner&lt;/em&gt; reflect a pragmatic understanding of modern technology use. For example, as the court in &lt;em&gt;Morgan&lt;/em&gt; questioned: &amp;ldquo;[t]oday, nearly all electronic interaction passes through third-party systems &amp;hellip;. Does that mean that anyone with a Gmail account has forfeited all rights to confidentiality and privacy?&amp;rdquo; 2026 WL 864223, at *4. This comparison suggests that some courts may be more sympathetic to litigants seeking work product-protection, depending on the factual circumstances, in light of the ubiquity of AI tools. &lt;/p&gt;
&lt;h2&gt;Open Questions and Unresolved Issues&lt;/h2&gt;
&lt;p&gt;Prior decisions have addressed whether an attorney&amp;rsquo;s use of AI tools in connection with legal strategy or litigation preparation qualifies as work product.[[N: T&lt;em&gt;remblay v. OpenAI, Inc.&lt;/em&gt;, No. 23-cv-03223, 2024 WL 3748003, at *2 (N.D. Cal. Aug. 8, 2024) (&amp;ldquo;ChatGPT prompts were queries crafted by counsel and contain counsel&amp;rsquo;s mental impressions and opinions&amp;rdquo;); &lt;em&gt;Concord Music Group, Inc. v. Anthropic PBC&lt;/em&gt;, No. 24-cv-03811, 2025 WL 1482734, at *2 (N.D. Cal. May 23, 2025) (agreeing with &lt;em&gt;Tremblay&lt;/em&gt; that ChatGPT prompts are attorney work product).]] Several questions remain open, however. Courts have not resolved whether enterprise-grade AI systems, with contractual confidentiality protections and restricted data retention policies, alter the privilege analysis. The &lt;em&gt;pro se &lt;/em&gt;litigant cases do not address whether attorneys will receive the same work-product protection if they use publicly available AI tools when creating work product. Nor do they resolve the question that matters most for corporate clients: not whether an employee&amp;rsquo;s prompt is itself privileged, which &lt;em&gt;Heppner&lt;/em&gt; effectively answered in the negative, but whether an employee who inputs a lawyer&amp;rsquo;s privileged advice into a closed enterprise system waives the privilege, or whether that system&amp;rsquo;s contractual confidentiality and retention terms support a reasonable expectation of confidentiality that avoids waiver. In &lt;em&gt;Morgan&lt;/em&gt;, for example, the court entered a protective order requiring that confidential information be processed only using enterprise-tier AI accounts, which suggests that such accounts carry a more protectable privacy posture than consumer tools. 2026 WL 864223, at *7. But the court did not address privilege, and the question remains unresolved.&lt;/p&gt;
&lt;p&gt;Accordingly, companies and attorneys alike must be cautious when using AI to conduct pre-litigation case assessments or for daily use. For example, if an employee uses a publicly available AI tool to summarize or take notes of a meeting at which counsel provided legal advice, inputting that advice into the tool could be treated as a third-party disclosure that waives a privilege the communication would otherwise enjoy.
As courts continue to confront these issues, privilege analyses may increasingly turn on the contractual and privacy terms governing the particular AI use (including whether the platform was used as part of an enterprise license versus publicly available), the platform&amp;rsquo;s data retention and training practices, the nature of the information disclosed, and whether counsel directed or supervised the AI-assisted work.&lt;/p&gt;
&lt;h2&gt;Practical Implications for Life Sciences Companies&lt;/h2&gt;
&lt;p&gt;The implications of these developments are particularly acute for life sciences companies. Life sciences companies have widely adopted AI tools, and relevant legal advice frequently involves proprietary scientific information, regulatory strategy, intellectual property, clinical trial data, and commercially sensitive research that may be subject to discovery in fact-intensive post-acquisition litigation relying on expert opinions, including milestone and earnout disputes.&lt;/p&gt;
&lt;p&gt;Companies should assume that information shared with publicly available generative AI tools will be subject to discovery in a future litigation and that such interactions could constitute disclosure to a third party sufficient to waive privilege or work product protections. For example, in &lt;em&gt;Fortis Advisors, LLC v. Krafton, Inc.&lt;/em&gt;, the Delaware Court of Chancery ruled against Krafton, finding that it breached an acquisition agreement that provided for contingent earnout payments and allowed the founders and CEO to be terminated only for cause. 354 A.3d 906, 953 (Del. Ch. 2026). Krafton&amp;rsquo;s CEO had used ChatGPT for strategic advice to avoid earnout payments and relied on that advice. Id. at 927-28. In ruling against Krafton, the court rejected Krafton&amp;rsquo;s explanation for firing certain founders, basing its opinion, in part, on evidence of the CEO&amp;rsquo;s ChatGPT-designed strategy to force a deal on a term of the agreement or execute a takeover. Id. at 941 n.336. Accordingly, the court stated it would not permit Krafton to &amp;ldquo;use the after-acquired evidence doctrine to fabricate cause where the evidence shows the termination decision was made for different reasons.&amp;rdquo; Id. at 942. &lt;/p&gt;
&lt;p&gt;The &lt;em&gt;Fortis&lt;/em&gt; decision underscores the practical realities of AI usage: AI interactions may be highly probative evidence concerning corporate intent, strategy, and decision-making. Separate from any privilege or waiver question, AI-generated content may create &lt;a href="/en/perspectives/blogs/edata-edge/2026/05/court-rules-experts-ai-prompts-are-fair-game-under-rule-26"&gt;discoverable information&lt;/a&gt;&amp;nbsp;that plaintiffs or regulators later use to challenge a company&amp;rsquo;s stated rationale for business decisions. Prompts may even constitute discoverable expert reliance materials under the Federal Rules. Courts have also restricted how AI tools may be used in litigation. In &lt;em&gt;Jefferies v. Harcros Chemicals, Inc.&lt;/em&gt;, the court barred parties from uploading any discovery materials to publicly available AI tools, citing the inability to claw back information once it is incorporated into the model. Nos. 25-2352-KHV-ADM, 25-2569-KHV-ADM (D. Kan. 2026), ECF No. 152 at 7.&lt;/p&gt;
&lt;h2&gt;Best Practices and Risk Mitigation&lt;/h2&gt;
&lt;p&gt;Given the unsettled legal landscape, companies should always exercise caution when using generative AI tools in connection with legal or business matters, and counsel should adopt clear governance measures regarding AI use, particularly in legal contexts. &lt;/p&gt;
&lt;p&gt;Key considerations include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Avoid inputting privileged communications, litigation strategy, trade secrets, or confidential technical information into publicly available AI platforms.&lt;/li&gt;
    &lt;li&gt;Use enterprise tools governed by contractual confidentiality, no-training, and limited-retention terms.&lt;/li&gt;
    &lt;li&gt;Implement internal policies and trainings governing employee and in-house legal use of generative AI, including regarding privilege and confidentiality risks associated with AI platforms, and ensure close coordination between the business and legal departments on these issues.&lt;/li&gt;
    &lt;li&gt;Ensure that legal advice is clearly segregated from business discussions when using AI-assisted workflows.&lt;/li&gt;
    &lt;li&gt;Consider the role of outside counsel in supervising or directing AI-assisted internal investigations and litigation preparation.&lt;/li&gt;
    &lt;li&gt;Carefully evaluate vendor terms governing data retention, training, and access rights.&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{F92DA9A2-9D9E-427C-B12C-4006D1C6E2C7}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/06/bobby-mcmillin-discusses-biosecure-act-in-stat</link><title>Bobby McMillin Discusses Biosecure Act in STAT</title><description>Arnold &amp;amp; Porter Legislative &amp;amp; Public Policy partner Bobby McMillin was recently quoted by&lt;em&gt; STAT&lt;/em&gt; discussing the impact of the Biosecure Act and the potential for additional legislative and regulatory measures.&amp;nbsp;</description><pubDate>Tue, 30 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Legislative &amp;amp; Public Policy partner Bobby McMillin was recently quoted by &lt;em&gt;STAT&lt;/em&gt; discussing the impact of the Biosecure Act and the potential for additional legislative and regulatory measures. &lt;/p&gt;
&lt;p&gt;&amp;ldquo;The itch has not been entirely scratched,&amp;rdquo; Bobby said, in reference to policymakers&amp;rsquo; interest in attempting to counter the rise of Chinese biopharma companies. &lt;/p&gt;
&lt;p&gt;Bobby also noted that it took approximately two years for the Biosecure Act to pass, and that new legislative proposals could likewise take considerable time for Congress to consider. &lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.statnews.com/2026/06/25/china-biotech-next-steps-after-biosecure-act/" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required). &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1AADB2B8-2318-43BB-919C-3106E16F2F91}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/washington-states-cema-amendment-a-speedbump-not-a-roadblock</link><a10:author><a10:name>Jami Vibbert</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vibbert-jami</a10:uri><a10:email>jami.vibbert@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>E. Alex Beroukhim</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/beroukhim-e-alex</a10:uri><a10:email>alex.beroukhim@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Aaron E. Millstein</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/millstein-aaron-e</a10:uri><a10:email>Aaron.Millstein@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Elie Salamon</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/salamon-elie</a10:uri><a10:email>elie.salamon@arnoldporter.com</a10:email></a10:author><title>Washington State’s CEMA Amendment: A Speedbump, Not a Roadblock</title><description>Washington State has seen an explosion of lawsuits under its Commercial Electronic Mail Act (CEMA, Ch. 19.190 RCW), stemming from the Washington Supreme Court&amp;rsquo;s ruling last year in &lt;em&gt;Brown v. Old Navy&lt;/em&gt; expanding the scope of &amp;ldquo;false or misleading&amp;rdquo; email content.&amp;nbsp;Our latest Advisory examines what the new law changes, what it leaves unchanged, and the practical steps businesses should consider to reduce risk while navigating Washington&amp;rsquo;s evolving enforcement landscape.</description><pubDate>Tue, 30 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Summary&lt;/h2&gt;
&lt;p&gt;Washington State has seen an explosion of lawsuits under its Commercial Electronic Mail Act (CEMA, Ch. 19.190 RCW), stemming from the Washington Supreme Court&amp;rsquo;s ruling last year in&lt;em&gt; Brown v. Old Navy&lt;/em&gt; expanding the scope of &amp;ldquo;false or misleading&amp;rdquo; email content. &lt;/p&gt;
&lt;p&gt;As discussed by many commentators, the decision extended CEMA&amp;rsquo;s reach beyond traditional commercial advertising to include misleading email subject lines. Because statutory damages were previously set at $500 per message without the need to show actual damages, companies communicating electronically with Washington residents have faced new, sprawling exposure and must reevaluate compliance programs. &lt;/p&gt;
&lt;p&gt;CEMA has been a changing landscape with a recent statutory amendment going into effect to lower the statutory penalty and amend the knowledge requirement. Additionally, recent court decisions have provided further guidance on common defenses companies have been employing in CEMA class actions.&lt;/p&gt;
&lt;h2&gt;Recent Statutory Amendments&lt;/h2&gt;
&lt;p&gt;The surge in CEMA lawsuits did not go unnoticed. The Washington legislature took action this year passing HB 2274 in March 2026, which went into effect on June 11, 2026. Unfortunately, the amendment does nothing to help companies already facing CEMA litigation. The amendment applies solely to those lawsuits filed on or after June 11, 2026. For lawsuits filed before June 11, 2026, the law does not apply.&lt;/p&gt;
&lt;p&gt;The law was designed as a quick fix to address the flood of litigation over routine, non-deceptive emails that contained subject lines commonly used in marketing. Testimony in support of the bill highlighted these concerns, noting that CEMA does not require proof of any consumer harm and that the $500 statutory damages penalize companies for technical violations of the statute. &lt;/p&gt;
&lt;p&gt;HB 2274 addressed these issues in two ways:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;strong&gt;Statutory Damages&lt;/strong&gt;: Reducing the statutory penalty to $100 per violation&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Knowledge&lt;/strong&gt;: Removing the strict liability standard by requiring knowledge that the subject line was false or misleading&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;Specifically, HB 2274 amended RCW 19.190.020 to explicitly require a defendant had &amp;ldquo;actual knowledge or knowledge fairly implied on the basis of objective circumstances&amp;rdquo; that the subject line of the email contains false or misleading information. ESHB 2274, Sec. 1. This language is narrower than originally proposed to the legislature. The original bill would have also required proving that the subject line was likely &amp;ldquo;to mislead a recipient, acting reasonably under the circumstances, about a fact material to the relevant transaction &amp;hellip;&amp;rdquo; HB 2274, Sec. 1. But even the narrowed version substantially helps companies facing CEMA lawsuits.&lt;/p&gt;
&lt;p&gt;The amendment reduces the incentive for plaintiffs by lowering the statutory damages available and requiring some element of knowledge for false or misleading subject lines. By requiring plaintiffs to plead and prove that a defendant had actual knowledge, or knowledge fairly implied from objective circumstances, that a subject line was false or misleading, the amendment creates a substantial new evidentiary hurdle for plaintiffs, who must now plead and prove a defendant&amp;rsquo;s knowledge rather than rely on a strict liability standard. This additional element is likely to make CEMA claims for plaintiffs more challenging to litigate and win. With the effective date of June 11, 2026, plaintiffs rushed to file their class actions before then. But even a $100 statutory damages per violation remains an enticing prospect for plaintiffs. Accordingly, companies should still evaluate their marketing programs that include Washington State residents to ensure they are compliant.&lt;/p&gt;
&lt;h2&gt;Substantive Update From Recent Court Decisions&lt;/h2&gt;
&lt;p&gt;Most significantly, since our last update, federal courts in Washington are now questioning whether cases removed to federal court should be remanded for lack of Article III standing. See &lt;em&gt;Liss v. Skechers USA Inc.&lt;/em&gt;, No. 3:25-cv-05861-DGE, 2026 WL 1392327 (W.D. Wash. May 19, 2026); &lt;em&gt;Nuri v. True Religion Apparel&lt;/em&gt;, No: 2:25-cv-00690-LK, 2026 WL 864886 (W.D. Wash. March 30, 2026); &lt;em&gt;Montes v. Catalyst Brands&lt;/em&gt; LLC, No. 2:25-CV-0281-TOR, 2025 WL 3485827 (E.D. Wash. Dec. 4, 2025). This very issue is currently pending before the Ninth Circuit in &lt;em&gt;Montes v. Penney OpCo, LLC&lt;/em&gt;, No. 25-8045 (9th Cir.). The outcome may shape whether many of these cases remain in federal court at all.&lt;/p&gt;
&lt;p&gt;Courts have also begun ruling on other defenses, including whether the CAN-SPAM Act preempts CEMA and whether CEMA violates the U.S. Constitution&amp;rsquo;s dormant commerce clause. Federal courts presented with the preemption arguments have uniformly rejected them. See &lt;em&gt;Agnew v. Macy&amp;rsquo;s Retail Holdings, LLC&lt;/em&gt;, 2026 WL 764140 (W.D. Wash. Mar. 18, 2026); &lt;em&gt;Kempf v. Fullbeauty Brands Operations, LLC&lt;/em&gt;, 2026 WL 395677 (W.D. Wash. Feb. 12, 2026). Similarly, courts considering facial dormant commerce clause violations have rejected these defenses as well. See &lt;em&gt;Repperger v. Ulta Salon, Cosmetics &amp;amp; Fragrance&lt;/em&gt;, No. 2:25-cv-00526-RLP, 2026 WL 1157157 (E.D. Wash. Apr. 28, 2026).&lt;/p&gt;
&lt;p&gt;These recent decisions increase the risks associated with CEMA class actions in Washington. In assessing these potential defenses, defendants should keep in mind that neither issue has been decided by an appellate court and there may be unique factors that warrant consideration of each defense in a particular case. &lt;/p&gt;
&lt;p&gt;CEMA remains an active litigation front for companies in Washington with new developments each passing month. Our Seattle-based attorneys are well positioned to advise clients on CEMA compliance, defend class actions, and help companies align marketing practices with evolving state and federal requirements. &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E076F25D-90B4-4E96-8BFC-F7FE5EDD1630}</guid><link>https://ifila.org/young-ifila/young-ifila-london-2026-event/</link><author>Bart.Wasiak@arnoldporter.com</author><title>Critical Minerals and Critical Infrastructure Disputes Post-Pax Americana</title><pubDate>Tue, 30 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{464B5F71-9072-4987-9A7F-0DFB0DBB2622}</guid><link>https://www.biosliceblog.com/2026/06/virtual-and-digital-health-digest-june-2026/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emma Elliston, Ph.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/elliston-emma</a10:uri><a10:email>emma.elliston@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Shama Aktar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/aktar-shama</a10:uri><a10:email>shama.aktar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><title>Virtual and Digital Health Digest – June 2026</title><pubDate>Tue, 30 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{FCEF59BB-C2F9-4CB9-94B2-6B9D5DEE465E}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/usda-proposes-major-overhaul-of-afida-rules</link><a10:author><a10:name>Marisa N. Bocci</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bocci-marisa-n</a10:uri><a10:email>Marisa.Bocci@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jeffrey C. Thomson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomson-jeffrey-c</a10:uri><a10:email>jeff.thomson@arnoldporter.com</a10:email></a10:author><title>USDA Proposes Major Overhaul of AFIDA Rules</title><description>&lt;p&gt;On June 25, 2026, the U.S. Department of Agriculture (USDA) published a proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) that would significantly reshape the regulatory framework under the Agricultural Foreign Investment Disclosure Act of 1978 (AFIDA). The proposed rule would broaden what counts as &amp;ldquo;agricultural land,&amp;rdquo; narrow long-standing reporting exemptions, expand beneficial ownership disclosure, increase penalties, and move administration of the program to USDA&amp;rsquo;s Office of Homeland Security. A wide range of market participants could be affected, including institutional investors in farmland and timberland; commercial and rural-land developers; renewable energy and infrastructure developers; foreign persons and U.S.-organized entities with upstream foreign ownership; and even wholly domestic owners who lease to foreign tenants. Public comments are due August 10, 2026.&lt;/p&gt;
&lt;h2&gt;Who Counts as a &amp;ldquo;Foreign Person&amp;rdquo;?&lt;/h2&gt;
&lt;p&gt;Before turning to the proposed changes, it is worth pausing on a threshold point that is easy to overlook: AFIDA&amp;rsquo;s reporting obligations turn on whether a filer is a &amp;ldquo;foreign person,&amp;rdquo; and that term is defined far more broadly than many U.S. owners assume. A &amp;ldquo;foreign person&amp;rdquo; includes not only foreign individuals, foreign governments, and entities organized outside the United States, but also U.S.-organized entities in which foreign persons hold a &amp;ldquo;significant interest or substantial control.&amp;rdquo; A domestic entity can therefore be treated as a foreign person, and be drawn into AFIDA reporting, based solely on its upstream ownership. The proposed rule makes this more likely by lowering the aggregate-ownership threshold from 50% to 10%, and by counting beneficial owners and any interest held by a foreign adversary. A U.S. fund, partnership, or holding company should not assume AFIDA is inapplicable simply because it is organized domestically; the question turns on who holds direct and indirect interests in the entity. Separately, a wholly domestic landlord whose tenant is a foreign person may find that the tenant carries its own independent reporting obligation.&lt;/p&gt;
&lt;h2&gt;A National Security Initiative&lt;/h2&gt;
&lt;p&gt;The proposed rule is expressly framed as a national security measure rather than the data-collection exercise AFIDA has historically been. USDA ties the rulemaking to a January 2024 Government Accountability Office report finding that USDA had not shared timely or reliable AFIDA data with the Committee on Foreign Investment in the United States (CFIUS), and to the July 2025 National Farm Security Action Plan, which declares that &amp;ldquo;farm security is national security&amp;rdquo; and makes reform of the AFIDA process a top action item. A recurring theme throughout the proposed rule is improving the flow of AFIDA data to CFIUS and applying heightened scrutiny to foreign adversaries. It bears emphasis, however, that AFIDA remains a disclosure statute: it does not authorize USDA to block, condition, or unwind a transaction. National security review of farmland transactions continues to rest with CFIUS, which generally reaches agricultural land only where the land qualifies as &amp;ldquo;covered real estate&amp;rdquo; (for example, by proximity to a military installation) or forms part of a covered transaction.&lt;/p&gt;
&lt;h2&gt;Key Proposed Changes&lt;/h2&gt;
&lt;h3&gt;Expanded Definition of &amp;ldquo;Agricultural Land&amp;rdquo;&lt;/h3&gt;
&lt;p&gt;The proposed rule significantly broadens the definition of &amp;ldquo;agricultural land,&amp;rdquo; replacing the decades-old Standard Industrial Classification codes with current North American Industry Classification System (NAICS) codes and adding: solar and wind energy generation on agricultural land; pipeline transportation corridors; farm product warehousing and processing; conservation land that could be used for farming, ranching, forestry, or timber production; and agricultural research and development activities. The proposed rule would also eliminate the current exemption for tracts of 10 acres or less generating under $1,000 in annual receipts and, for the first time, make easements and rights-of-way for non-agricultural use reportable. Importantly, land meeting the definition would be treated as agricultural land regardless of local zoning classification. Owners of farmland, timberland, conservation land, renewable energy and pipeline interests, and path-of-growth real estate holdings may wish to reassess their portfolios for potential filing obligations.&lt;/p&gt;
&lt;h3&gt;Lease Exemption Dramatically Narrowed&lt;/h3&gt;
&lt;p&gt;Currently, leaseholds of less than 10 years are exempt from AFIDA reporting. Under the proposed rule, that exemption would be reduced to leases of less than one year for most foreign persons, and eliminated entirely for entities from or controlled by foreign adversary countries (China, Russia, Iran, North Korea, and others designated by the Secretary of State). Short-term agricultural leases, crop production arrangements, and energy site leases that are currently exempt may become reportable.&lt;/p&gt;
&lt;h3&gt;Enhanced Beneficial Ownership and Structural Disclosure&lt;/h3&gt;
&lt;p&gt;Foreign persons that are neither individuals nor governments, including funds, partnerships, and corporate entities, would face substantially expanded disclosure requirements. The proposed rule would lower the threshold at which aggregated foreign interests constitute &amp;ldquo;significant interest or substantial control&amp;rdquo; from 50% to 10% (USDA has asked for comment on a 5% threshold) and would eliminate the current reporting exemptions for certain shareholders. The proposed rule would require: identification of all persons holding 10% or more of any interest (individually or in aggregate); identification of all &amp;ldquo;beneficial owners,&amp;rdquo; defined broadly to include anyone exercising decision-making authority over the land regardless of percentage held; ownership diagrams depicting the relationship between all interest holders; tax identification numbers and passport numbers for all foreign persons; and disclosure of shell corporation structures at all intermediary tiers. Filers would also have to submit a digital, open-source geospatial map delineating the land and its uses, together with current acreage. The proposed definition of &amp;ldquo;shell corporation&amp;rdquo; is broadly drawn and may capture holding vehicles common in institutional real estate structures.&lt;/p&gt;
&lt;h3&gt;Stricter Penalties: Restructured and Increased&lt;/h3&gt;
&lt;p&gt;The proposed rule significantly increases civil penalties and removes the existing provisions allowing downward adjustment of penalties. It would create three separate late-filing penalty schemes (for acquisitions and holdings, for transfers and inheritances, and for newly reportable holdings), each beginning with an initial $250 penalty assessed on the 91st day. Thereafter, penalties accrue on two tracks: entities designated as foreign adversaries or foreign-adversary-controlled entities would accrue 2.5% of fair market value per week, and all other foreign persons 1.5% per week. For portfolios holding multiple parcels, exposure could compound substantially.&lt;/p&gt;
&lt;h3&gt;Electronic Filing and New Portal&lt;/h3&gt;
&lt;p&gt;All AFIDA filings would have to be submitted through USDA&amp;rsquo;s new online portal (afida.landmark.usda.gov), which requires a Login.gov account. The paper FSA-153 form would be phased out, and the proposed rule removes form-specific references so that USDA can deploy a new electronic form. Filers who cannot access the portal could seek assistance from their local Farm Service Agency (FSA) office.&lt;/p&gt;
&lt;h3&gt;Administration Transferred to Office of Homeland Security&lt;/h3&gt;
&lt;p&gt;Administration of AFIDA is moving out of FSA. A separate final rule issued April 13, 2026 already transferred AFIDA authority from FSA to USDA&amp;rsquo;s Assistant Secretary for Administration, and this proposed rule would codify the sub-delegation of day-to-day administration to USDA&amp;rsquo;s Office of Homeland Security (OHS), a change that reflects the program&amp;rsquo;s more explicit national security orientation. FSA would remain the initial point of contact for filers and would assist with fair market value determinations. The proposed rule also overhauls penalty appeals: the response window would shrink from 60 to 30 days; the options to submit a written statement contesting liability or to request a hearing would be eliminated in favor of a single review by the OHS Director; payment would be required electronically through pay.gov; and decisions would be administratively final, with unpaid penalties referred to the U.S. Department of Justice.&lt;/p&gt;
&lt;h2&gt;Interaction With State Law&lt;/h2&gt;
&lt;p&gt;AFIDA operates alongside a growing patchwork of state laws. Roughly two dozen states now restrict foreign ownership of agricultural land or impose their own reporting requirements, and these vary widely in scope, triggers, and penalties. Compliance with AFIDA does not satisfy these separate state obligations. The proposed rule states that conflicting state and local laws would be preempted, while also reminding filers that they must continue to comply with applicable state and local restrictions and that USDA will keep sharing filings with state departments of agriculture. That tension, together with pending constitutional challenges to certain state foreign-ownership statutes, leaves the federal-state landscape unsettled.&lt;/p&gt;
&lt;h3&gt;What This Means for Investors and Landowners&lt;/h3&gt;
&lt;p&gt;If finalized, the rule would likely require many parties that are currently exempt, or that have never considered themselves subject to AFIDA, to evaluate new disclosure obligations. The proposed rule includes a limited safe harbor period to allow parties time to make compliant filings if deemed necessary. Different categories of market participants could be affected in different ways:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Institutional investors in farmland and timberland&lt;/strong&gt;: Assess whether holdings fall within the expanded definition of agricultural land and whether fund, joint venture, or trust structures cross the lowered 10% aggregate threshold or trigger the new beneficial-ownership and ownership-diagram disclosures. Also, whether the reduced acreage area and changes to leasehold reporting requirements have expanded prior reporting obligations.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Commercial and rural-land developers&lt;/strong&gt;: Pre-development or path-of-growth parcels that were farmed or grazed within the prior five years may qualify as agricultural land even if rezoned for another use; this proposed rule clarifies that the filing obligation would apply regardless of local zoning.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Renewable energy and infrastructure developers&lt;/strong&gt;: Solar, wind, and pipeline interests, as well as easements and rights-of-way, may be reportable, including under site-control leases that were previously exempt.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;U.S. entities with upstream foreign ownership&lt;/strong&gt;: These parties face the most extensive new disclosure, including ownership diagrams, identifiers, and geospatial maps. Where a foreign adversary is involved, they also face the higher penalty track and the loss of lease exemptions.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The proposed rule provides a 90-day window after the final rule&amp;rsquo;s effective date for newly reportable holdings to come into compliance, along with a one-year reduced-penalty transition period. We are monitoring this rulemaking and can assist with assessing portfolio exposure, preparing public comments, and compliance planning. Comments on the proposed rule are due August 10, 2026.&lt;/p&gt;
&lt;p&gt;The proposed changes could have important implications for foreign investors, agribusinesses, lenders, renewable energy companies, and other organizations with interests in U.S. real estate. This alert is for informational purposes only and does not constitute legal advice.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</description><pubDate>Tue, 30 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{FE67D4D1-BEB3-4DCD-A276-4949EA1ABADC}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/06/james-joseph-quoted-in-the-chronicle-of-philanthropy-on-evolving-trends-in-major-donor-giving</link><title>James Joseph Quoted in The Chronicle of Philanthropy on Evolving Trends in Major Donor Giving</title><description>James Joseph, Arnold &amp;amp; Porter partner and co-chair of the firm's Tax practice, was quoted in &lt;em&gt;The Chronicle of Philanthropy&lt;/em&gt; article, "Are Wealthy Donors Giving Big Again? Yes. But It's Complicated," examining how wealthy donors are navigating charitable giving amid continued political and economic uncertainty.</description><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;James Joseph, Arnold &amp;amp; Porter partner and co-chair of the firm's Tax practice, was quoted in &lt;em&gt;The Chronicle of Philanthropy&lt;/em&gt; article, "Are Wealthy Donors Giving Big Again? Yes. But It's Complicated," examining how wealthy donors are navigating charitable giving amid continued political and economic uncertainty.&lt;/p&gt;
&lt;p&gt;Jim explained that while many affluent donors paused or reconsidered their giving amid heightened uncertainty, they are increasingly moving forward with major gifts as they adapt to a changing philanthropic landscape. "People have just decided or figured out they're going to have to live with this political uncertainty and they can't do nothing forever, whatever the risks are," he said.&lt;/p&gt;
&lt;p&gt;He noted that concerns about heightened scrutiny of charitable giving have influenced how donors give rather than whether they give. Some philanthropists are broadening their charitable strategies by supporting organizations with wider missions, such as serving low-income communities across demographics.&lt;/p&gt;
&lt;p&gt;Jim also observed that the current fundraising environment favors long-standing donor relationships. "It's really hard to cultivate new donors in this environment," he noted, advising nonprofit organizations to engage their most committed supporters with realistic conversations about organizational needs and how they can provide meaningful assistance.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.philanthropy.com/news/are-wealthy-donors-giving-big-again-yes-but-its-complicated/" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A0FDBB43-25D6-4776-9E22-DF808CEFCEAF}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/arnold-porter-represents-chemours-in-first-comprehensive-federal-pfas-settlement</link><title>Arnold &amp; Porter Represents Chemours in First Comprehensive Federal PFAS Settlement</title><description>Arnold &amp;amp; Porter recently advised The Chemours Company in its settlement to resolve claims asserted by the U.S. Environmental Protection Agency (EPA) relating to per- and polyfluoroalkyl (PFAS) discharges and other alleged non-compliance actions, primarily at the company&amp;rsquo;s New Jersey, North Carolina, and West Virginia facilities.&amp;nbsp;</description><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised &lt;a rel="noopener noreferrer" href="https://www.prnewswire.com/news-releases/chemours-reaches-agreement-with-us-epa-to-resolve-claims-relating-to-pfas-302809444.html" target="_blank"&gt;The Chemours Company&lt;/a&gt; in its settlement to resolve claims asserted by the U.S. Environmental Protection Agency (EPA) relating to per- and polyfluoroalkyl (PFAS) discharges and other alleged non-compliance actions, primarily at the company&amp;rsquo;s New Jersey, North Carolina, and West Virginia facilities. &lt;/p&gt;
&lt;p&gt;This is the first comprehensive federal agreement with a major manufacturer of PFAS substances. The settlement both provides the industry with greater clarity on future compliance requirements and actions to support long-term responsible manufacturing and acknowledges Chemours&amp;rsquo; role in manufacturing critical materials for military and commercial use. &lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has extensive experience defending and advising companies regarding &lt;a href="/en/services/capabilities/practices/environmental-enforcement-toxic-tort-litigation/pfas"&gt;PFAS&lt;/a&gt;, including in litigation, regulatory, and legislative matters, bringing to bear our deep understanding of federal and state environmental and toxic tort law. &lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Environmental Co-Chair Allison Rumsey and senior counsel Lawrence Culleen and Joel Gross. &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{01D924EB-9A46-4034-80E2-5D5363B0167E}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/managing-ip-names-four-arnold-porter-lawyers-as-western-europe-ip-stars</link><title>Managing IP Names Four Arnold &amp; Porter Lawyers as Western Europe IP Stars</title><description>&lt;em&gt;Managing IP&lt;/em&gt; recently recognized Arnold &amp;amp; Porter in its 2026 IP Stars Western Europe rankings as an &amp;ldquo;Other Notable Firm&amp;rdquo; for IP Transactions in the United Kingdom (England).</description><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;em&gt;Managing IP&lt;/em&gt; recently recognized Arnold &amp;amp; Porter in its 2026 IP Stars Western Europe rankings as an &amp;ldquo;Other Notable Firm&amp;rdquo; for IP Transactions in the United Kingdom (England).&lt;/p&gt;
&lt;p&gt;The guide also highlighted four Arnold &amp;amp; Porter lawyers for their individual achievements in intellectual property, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;George Jenkins &amp;mdash; Transactions Star (United Kingdom, England)&lt;/li&gt;
    &lt;li&gt;Beatriz San Martin &amp;mdash; Patent Star (United Kingdom, England)&lt;/li&gt;
    &lt;li&gt;Ewan Townsend &amp;mdash; Notable Practitioner (United Kingdom, England)&lt;/li&gt;
    &lt;li&gt;Tom Wilson &amp;mdash; Rising Star (United Kingdom, England)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;IP Stars compiles peer and client feedback on attorneys and ranks senior practitioners who are leaders in intellectual property, taking into account expertise, workload, and outcomes achieved for clients. &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E1595BCD-66DB-4F88-920E-C96EB279F3ED}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/06/virtual-digital-health-digest</link><a10:author><a10:name>Allison W. Shuren</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shuren-allison-w</a10:uri><a10:email>allison.shuren@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abeba Habtemariam</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/habtemariam-abeba</a10:uri><a10:email>Abeba.Habtemariam@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nancy L. Perkins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/perkins-nancy-l</a10:uri><a10:email>nancy.perkins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Casey Brouhard</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brouhard-casey</a10:uri><a10:email>casey.brouhard@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mickayla A. Stogsdill</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/stogsdill-mickayla</a10:uri><a10:email>mickayla.stogsdill@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Shama Aktar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/aktar-shama</a10:uri><a10:email>shama.aktar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emma Elliston, Ph.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/elliston-emma</a10:uri><a10:email>emma.elliston@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brianna Morigney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/morigney-brianna</a10:uri><a10:email>brianna.morigney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lily Cao</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cao-lily</a10:uri><a10:email>lily.cao@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Caroline Oliver</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/oliver-caroline</a10:uri><a10:email>caroline.oliver@arnoldporter.com</a10:email></a10:author><title>Virtual &amp; Digital Health Digest</title><description>This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2026 from the United States, United Kingdom, and European Union.</description><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2026 from the United States, United Kingdom, and European Union.&lt;/p&gt;
&lt;h2&gt;In this issue, you will find the following:&lt;/h2&gt;
&lt;h3&gt;U.S. News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Health Care Fraud And Abuse Updates"&gt;Health Care Fraud and Abuse Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy and AI Updates"&gt;Privacy and Artificial Intelligence (AI) Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;U.S. Featured Content &lt;/h3&gt;
&lt;p&gt;This month&amp;rsquo;s June Digest includes the sentencing of three defendants in a telemedicine fraud scheme involving more than $1.97 billion in fraudulent prescriptions and $758 million paid by private insurers; a $62,500 False Claims Act settlement with Illinois physician Dr. Alexandria Williams related to allegedly medically unnecessary durable medical equipment (DME) orders; and the conviction of HealthSplash founder Brett Blackman for his role in the DMERx platform and a Medicare fraud scheme involving more than $1 billion billed and over $450 million paid. This Digest also covers the House Energy and Commerce Subcommittee&amp;rsquo;s June 3, 2026 hearing on the proposed Securing and Establishing Consumer Uniform Rights and Enforcement over Data Act (SECURE Data Act) and related debate over federal privacy standards and state law preemption, as well as Mayo Clinic and Microsoft&amp;rsquo;s collaboration to develop a frontier AI model for clinical use. Federal policy developments include congressional resolutions seeking disapproval of the Centers for Medicare &amp;amp; Medicaid Services&amp;rsquo; (CMS) Wasteful and Inappropriate Service Reduction (WISeR) model for artificial intelligence (AI)-enabled prior authorization, CMS&amp;rsquo; planned &amp;ldquo;Gold Card&amp;rdquo; approach for high-performing providers, the White House Executive Order on advanced AI innovation and cybersecurity, and the Great American AI Act discussion draft, which would establish federal AI standards infrastructure, impose risk framework and audit obligations on large frontier model developers, and temporarily preempt certain state AI laws.&lt;/p&gt;
&lt;h3&gt;EU and UK News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#IP Updates"&gt;IP Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;EU/UK Featured Content &lt;/h3&gt;
&lt;p&gt;May 2026 saw continued momentum across the European Union (EU) and United Kingdom (UK) toward modernizing and streamlining the regulatory landscape for digital health, with a particular focus on accommodating AI-enabled technologies while reducing unnecessary complexity. A central development was the provisional agreement on the Digital Omnibus package, which seeks to simplify the application of the EU AI Act by clarifying overlaps with sector-specific legislation, deferring key obligations, and introducing more proportionate requirements.&lt;/p&gt;
&lt;p&gt;In parallel, regulators on both sides of the Channel are advancing reforms to ensure that medical device frameworks remain fit for purpose in an increasingly software-driven and data-centric environment. In the EU, the activation of key European Database on Medical Devices (EUDAMED) modules marks a major step toward enhanced transparency and traceability, while ongoing discussions on the Medical Devices Regulation 2017/745 (MDR)/In Vitro Diagnostic Regulation 2017/746 (IVDR) revisions highlight a strong policy drive toward simplification and better integration of AI. In the UK, the Medicines and Healthcare products Regulatory Agency&amp;rsquo;s (MHRA) proposed pre-market reforms and broader thinking on AI regulation signal a shift toward more flexible, lifecycle-based oversight, with greater emphasis on post-market monitoring and innovation support.&lt;/p&gt;
&lt;p&gt;Data governance and cybersecurity also remain high on the agenda. Industry and regulators alike are emphasizing the need for coherent, proportionate frameworks that avoid duplication while enabling innovation, particularly in light of expanding AI use cases and global supply chains. Together, these developments reflect a broader trend toward risk-based, innovation-friendly regulation, coupled with increasing expectations around transparency, accountability, and data protection in digital health.
&lt;/p&gt;
&lt;h2&gt;U.S. News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Health Care Fraud And Abuse Updates"&gt;Health Care Fraud And Abuse Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/three-members-international-criminal-organization-sentenced-lengthy-sentences-2-billion" target="_blank"&gt;Three Members of International Criminal Organization Sentenced for Telemedicine Health Care Fraud Scheme&lt;/a&gt;&lt;/strong&gt;. On May 19, 2026, three defendants were sentenced for their role in a telemedicine fraud scheme. Between 2017 and 2022, the defendants allegedly operated domestic and international call centers that contacted patients enrolled with private insurers and offered them medications at no cost and without any medical evaluation. Regardless of whether beneficiaries agreed to receive medication, the defendants allegedly generated fraudulent prescriptions in their names. Allegedly, the defendants also recruited physicians purportedly to review prescriptions following telemedicine visits, but in most cases no such visits ever occurred. Prescriptions were generated under those physicians&amp;rsquo; names and provider identification numbers without their knowledge, and many beneficiaries never actually received the medications. As a result, the defendants submitted over $1.97 billion in fraudulent prescriptions, of which private insurers paid $758 million.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/usao-ma/pr/illinois-doctor-agrees-pay-62500-signing-false-orders-durable-medical-equipment-scheme" target="_blank"&gt;Illinois Doctor Agrees to Pay $62,500 to Resolve False Medicare Claims Allegations&lt;/a&gt;&lt;/strong&gt;. On May 19, 2026, an Illinois-based physician, Dr. Alexandria Williams, agreed to pay $62,500 to resolve civil allegations that she caused the submission of false Medicare claims for medically unnecessary DME. The government alleged that Dr. Williams signed pre-populated DME orders generated from telemarketing calls to Medicare beneficiaries. Those orders allegedly contained false certifications, including that she had evaluated the patient, discussed orthotic use, and provided follow-up care instructions, none of which occurred. She allegedly received payment per signed order through a telemedicine company whose owner had previously pleaded guilty to his role in the scheme.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/owner-health-care-software-company-convicted-1-billion-dollar-medicare-fraud-conspiracy" target="_blank"&gt;Federal Jury Convicts Health Care Software CEO in $1 Billion Medicare Fraud Scheme&lt;/a&gt;&lt;/strong&gt;. On May 14, 2026, a federal jury convicted Brett Blackman, founder and owner of HealthSplash, for his role in operating DMERx, a platform that generated false physicians&amp;rsquo; orders and prescriptions for Medicare and other federal health care benefit program reimbursements. The scheme allegedly involved aggressively targeting hundreds of thousands of Medicare beneficiaries, typically through foreign call centers and mass mailers, to accept medically unnecessary orthotic braces and other items. Telemedicine physicians were then paid illegal kickbacks to sign false prescription orders, in some cases without any patient interaction. Fraudulent orders falsely represented that the physician had examined the patient and performed in-person tests.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;In total, the scheme billed Medicare and other federal health care programs over $1 billion, of which Medicare and other insurers paid more than $450 million. We previously discussed the conviction of Blackman&amp;rsquo;s co-conspirator in our &lt;a href="/en/perspectives/publications/2025/06/virtual-and-digital-health-digest"&gt;June 2025 Digest&lt;/a&gt;.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy and AI Updates"&gt;Privacy and AI Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;House Subcommittee Debates Proposed Federal Privacy Legislation&lt;/strong&gt;. On June 3, 2026, a Subcommittee of the House Energy and Commerce Committee held a hearing on the proposed &lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/8413/text?s=1&amp;amp;r=2" target="_blank"&gt;SECURE Data Act&lt;/a&gt;, which was introduced in April and would establish national data privacy and security standards that would preempt any related state laws. At the hearing, Republican members of the subcommittee, as well as Ashli Watts, President and CEO of the Kentucky Chamber of Commerce, voiced strong support for the bill, emphasizing that it incorporates the fundamental elements of almost all of the more than 20 state privacy laws that have been enacted in the past decade while creating uniform standards for businesses nationwide. The bill drew sharp criticism from committee Democrats, however, and from Caitriona Fitzgerald, Deputy Director and Policy Director at the Electronic Privacy Information Center, who testified that the technology industry was pressing for enactment of the bill as a means to preempt the states from &amp;ldquo;doing anything for all of time on privacy.&amp;rdquo; Her testimony echoed statements made in a&lt;a rel="noopener noreferrer" href="https://aboutblaw.com/blU5" target="_blank"&gt; letter&lt;/a&gt; sent the day of the hearing to both House and Senate leaders from the Attorneys General of 18 states. Although the SECURE Data Act will likely advance to a markup, its path ahead will not be smooth.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Mayo Clinic and Microsoft Announce AI Collaboration&lt;/strong&gt;. Also on June 2, 2026, the Mayo Clinic and Microsoft &lt;a rel="noopener noreferrer" href="https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-and-microsoft-collaborate-to-develop-a-frontier-ai-model-for-healthcare/" target="_blank"&gt;announced &lt;/a&gt;that they have formed a strategic collaboration to develop and deploy a frontier AI model for use in health care. According to the announcement, the model will be designed to synthesize diverse clinical data in order to facilitate earlier diagnoses, more personalized treatment decisions, and better patient outcomes. It will initially be deployed within Mayo Clinic&amp;rsquo;s clinical environment, where it can be periodically tested, refined, and improved through real-world use. The Mayo Clinic will maintain ownership of the model, and Microsoft will make it globally available through Azure Foundry APIs.
&lt;/p&gt;
&lt;h3&gt;&lt;a name="Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;On May 19, 2026, a group of 20 Senate Democrats, led by Sen. Ron Wyden (D-OR), &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.finance.senate.gov%2Franking-members-news%2Fwyden-senate-democrats-take-action-to-roll-back-trump-ai-care-denial-experiment-on-seniors&amp;amp;data=05%7C02%7CMickayla.Stogsdill%40arnoldporter.com%7C3e7583bf704f4e968e6108dec668a307%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639166349897091039%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=MIZnxCVPu3JooV2w0106ZTejE9Pdv9JyawxHTHAFCno%3D&amp;amp;reserved=0" target="_blank"&gt;introduced&lt;/a&gt; a joint resolution (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/senate-joint-resolution/192" target="_blank"&gt;S.J.Res. 192&lt;/a&gt;) that would provide for congressional disapproval of the rule submitted to the CMS related to the implementation of AI-enabled prior authorization for select services under the&lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/wiser" target="_blank"&gt; WISeR &lt;/a&gt;model. Reps. Greg Landsman (D-OH) and Suzan DelBene (D-WA) introduced an identical joint resolution (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-joint-resolution/187" target="_blank"&gt;H.J.Res. 187&lt;/a&gt;) in the House.&amp;nbsp;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The introduction of the resolutions follows the Government Accountability Office&amp;rsquo;s (GAO) recent &lt;a rel="noopener noreferrer" href="https://www.gao.gov/products/b-337994" target="_blank"&gt;determination&lt;/a&gt; that the WISeR model should be subject to the rulemaking requirements of the Congressional Review Act (CRA). Under the CRA, a joint resolution of disapproval passed by both chambers of Congress and signed by the president will invalidate a final rule issued by a federal agency. The enactment of a joint resolution of disapproval also prevents the reissuing of any rule that is &amp;ldquo;substantially the same in nature.&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;CMS Administrator Mehmet Oz &lt;a rel="noopener noreferrer" href="https://aboutbgov.com/blKJ?utm_campaign=health_tech&amp;amp;utm_medium=email&amp;amp;_hsenc=p2ANqtz-9P7qWGWUokMCr52n1qhltpo-c01Qpbd-fcq-CJKJqsBaxhzSUTPrslSaAEKylubSUaZtjV3TiCGvnu5FHF09d1bi7HvVdpN9H8g-r7MGVniUZbF6o&amp;amp;_hsmi=419421341&amp;amp;utm_content=419421341&amp;amp;utm_source=hs_email" target="_blank"&gt;shared&lt;/a&gt; that CMS plans to implement a &amp;ldquo;Gold Card&amp;rdquo; program for WISeR as soon as mid-year, which will exempt &amp;ldquo;high performing&amp;rdquo; providers from review under the program.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;On June 2, 2026, the White House released its delayed &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/presidential-actions/2026/06/promoting-advanced-artificial-intelligence-innovation-and-security/" target="_blank"&gt;Executive Order&lt;/a&gt; (EO), &amp;ldquo;Promoting Advanced Artificial Intelligence Innovation and Security,&amp;rdquo; to address AI cybersecurity threats. The finalized EO is a scaled-back version of the draft circulated in late May. The EO would seek to improve cybersecurity and secure critical systems across the government. Additionally, the order asks AI companies to enter their frontier models into a voluntary government review program 30 days prior to public release. The previous version of the order asked developers to submit 90 days prior to release.&lt;/p&gt;
&lt;p&gt;On June 3, 2026, OpenAI CEO Sam Altman met with congressional leaders, including Speaker Mike Johnson (R-LA), to discuss OpenAI&amp;rsquo;s new &lt;a rel="noopener noreferrer" href="https://cdn.openai.com/pdf/25752ecb-0e5c-47f9-b9e4-c0f4d76f8d3d/a-blueprint-for-a-federal-framework.pdf" target="_blank"&gt;policy blueprint&lt;/a&gt; and a new discussion draft of the Great American AI Act (GAAIA, &lt;a rel="noopener noreferrer" href="https://trahan.house.gov/uploadedfiles/gaaia_discussion_draft_section-by-section.pdf" target="_blank"&gt;section-by-section&lt;/a&gt;, &lt;a rel="noopener noreferrer" href="https://trahan.house.gov/uploadedfiles/2026.06.03_trahan_obernolte_ai_framework_faq.pdf" target="_blank"&gt;FAQs&lt;/a&gt;) released by Reps. Jay Obernolte (R-CA) and Lori Trahan (D-MA). The 269-page bill is a comprehensive AI legislative framework and includes new guardrails for AI developers and would preempt state AI laws related to AI development for three years. The new safety provisions include the creation of the Center for AI Standards and Innovation (CAISI) at the U.S. Department of Commerce to set voluntary standards, develop evaluation tools, monitor AI progress, and run an accreditation system for Independent Verification Organizations (IVOs). It would also require large frontier model developers with revenue greater than $500 million to publish frameworks outlining their risk mitigation plans for their models and submit to compliance audits from the IVOs accredited by CAISI. Notably, the audit requirement would also expire in three years.&lt;/p&gt;
&lt;h3&gt;&lt;a name="FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/h3&gt;
&lt;h4&gt;FDA Extends Comment Period for AI-Enabled Early-Phase Clinical Trials Pilot RFI&lt;/h4&gt;
&lt;p&gt;FDA has extended the comment period for its &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/05/28/2026-10602/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information" target="_blank"&gt;Request for Information&lt;/a&gt; (RFI) on a proposed AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Comments are now due June 29, 2026, 30 days after the original May 29 deadline. The &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information" target="_blank"&gt;RFI&lt;/a&gt; seeks input on how AI-enabled technologies could improve efficiency, safety monitoring, dose selection, adaptive trial design, biomarker assessment, patient recruitment and stratification, endpoint validation, and early Phase 1-to-Phase 2 go/no-go decision-making in early-phase clinical trials. FDA describes early-phase trials as a bottleneck in drug development due to uncertainty around dosing, safety, and efficacy; limited patient populations; inefficient progression decisions; long timelines; and significant resource demands. The proposed pilot would involve sponsors pursuing early-phase trials through applications submitted to CDER, CBER, and the Oncology Center of Excellence, and would be coordinated by the Deputy Chief Medical Officer within the Office of the Commissioner. FDA is seeking feedback on pilot design, participant selection, collaboration models, operational infrastructure, timelines, knowledge sharing, and evaluation metrics. FDA also emphasizes that the pilot would be guided by trustworthy AI principles aligned with the NIST AI Risk Management Framework, including validity, safety, security, accountability, explainability, privacy protection, and fairness. Comments should reference Docket No. FDA-2026-N-4390.&lt;/p&gt;
&lt;h4&gt;FDA Classifies Radiological Machine Learning-Based Quantitative Imaging Software With PCCP as Class II Device&lt;/h4&gt;
&lt;p&gt;FDA has issued a &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/06/17/2026-12166/medical-devices-radiology-devices-classification-of-the-radiological-machine-learning-based" target="_blank"&gt;final order&lt;/a&gt; classifying radiological machine learning-based quantitative imaging software with a predetermined change control plan (PCCP) as a Class II device subject to special controls. The order takes effect on June 17, 2026.&lt;/p&gt;
&lt;p&gt;The device type covers software-only products that use machine learning algorithms on radiological images to produce quantitative imaging outputs, including functions such as view selection, segmentation, and landmarking. The classification also addresses planned software modifications made under an authorized PCCP.&lt;/p&gt;
&lt;p&gt;FDA classified the device type through the De Novo pathway after reviewing Caption Health, Inc.&amp;rsquo;s request for its Caption Interpretation Automated Ejection Fraction Software. FDA concluded that special controls, together with general controls, provide reasonable assurance of safety and effectiveness while reducing the regulatory burden compared with automatic Class III classification.&lt;/p&gt;
&lt;p&gt;The special controls address risks such as inaccurate outputs, inaccurate results following PCCP-authorized modifications, and user misunderstanding of software changes. They require detailed documentation of algorithms and training data, independent performance testing, subgroup analyses, software verification and validation, risk management for planned modifications, and labeling that describes the device&amp;rsquo;s validated population, intended users, inputs and outputs, compatible imaging hardware and protocols, performance, limitations, PCCP status, version history, and user notification process.&lt;/p&gt;
&lt;p&gt;The device type remains subject to 510(k) premarket notification requirements, and the new De Novo classification may serve as a predicate for future substantially equivalent devices.&lt;/p&gt;
&lt;h4&gt;FDA Updates Lists of Authorized Medical Devices Incorporating Digital Health Technologies&lt;/h4&gt;
&lt;p&gt;FDA has updated its searchable lists of medical devices authorized for marketing in the United States that incorporate certain digital health technologies, including artificial intelligence (AI), augmented reality and virtual reality (AR/VR), and sensor-based digital health technologies. The lists are intended to provide transparency into the landscape of FDA-authorized digital health-enabled devices and may help developers, providers, patients, and other stakeholders understand how these technologies are used in regulated medical devices. The updated list now includes more than 1,500 AI/ML devices.&lt;/p&gt;
&lt;h2&gt;EU and UK News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://ec.europa.eu/newsroom/sante/newsletter-archives/74172" target="_blank"&gt;&lt;/a&gt;&lt;strong&gt;&lt;a href="https://data.consilium.europa.eu/doc/document/ST-9247-2026-INIT/en/pdf" target="_blank"&gt;Council of the European Union (Council) and European Parliament Reach Provisional Agreement on the Revised EU AI Rules&lt;/a&gt;&lt;/strong&gt;. On May 7, 2026, the Council and European Parliament reached a provisional political agreement on the EU AI Act component of the EU Digital Omnibus package, which aims to simplify the implementation of harmonized rules on AI under the EU AI Act (see our &lt;a href="/en/perspectives/publications/2026/04/virtual-digital-health-digest"&gt;April 2026 Digest&lt;/a&gt;&amp;nbsp;and our &lt;a href="/en/perspectives/advisories/2026/02/eu-digital-omnibus-what-the-proposed-reforms-mean-for-pharma-and-medtech"&gt;February 2026 Advisory &lt;/a&gt;for more details on the EU Digital Omnibus). The agreement would postpone the application of obligations on high-risk AI until December 2, 2027 for standalone high-risk AI systems and until August 2, 2028 for high-risk AI systems embedded in products subject to EU sectoral legislation, including medical devices and in-vitro diagnostics (IVDs). The agreement also introduces measures intended to reduce overlaps between the AI Act and sector-specific legislation, narrows the definition of &amp;ldquo;safety component&amp;rdquo; potentially limiting the scope of certain high-risk obligations, and introduces more proportionate requirements for small and medium enterprises (SMEs) and small mid-cap enterprises. The text remains subject to formal adoption by both institutions before entering into force. Read our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/05/eu-ai-act-omnibus-provisional-deal-announced-initial-reflections-for-life-sciences-companies/" target="_blank"&gt;May 2026 BioSlice Blog&lt;/a&gt; for more details on the agreement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/calls-for-evidence/pre-market-medical-devices-regulation-stakeholder-impact-survey" target="_blank"&gt;MHRA&amp;rsquo;s Call for Evidence on Draft Pre-Market Medical Devices Regulation&lt;/a&gt;&lt;/strong&gt;. The MHRA launched a call for evidence in the form of a stakeholder impact survey on newly proposed changes to UK legislation on pre-market medical device and IVD requirements, as set out in the &lt;a rel="noopener noreferrer" href="https://members.wto.org/crnattachments/2026/TBT/GBR/26_02425_00_e.pdf" target="_blank"&gt;draft Medical Devices (Amendment) Regulations 2026&lt;/a&gt;. The survey closed on June 19, 2026 and is intended to inform the government&amp;rsquo;s future implementation of these reforms, which aim to introduce more proportionate, patient‑centered requirements while supporting access to innovative technologies. In particular, the proposals integrate software within the broader active device classification rules (rather than there being a designated classification rule on software as there currently is within the EU rules), propose additional Unique Device Identification requirements for software, and introduce the concept of &amp;ldquo;pre-determined change control plans&amp;rdquo; as a mechanism to describe future modifications to devices, including for software, and how they will be assessed. Read about some of the key proposals in our recent &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/05/draft-uk-medical-device-amending-regulations-key-proposals-and-mhra-call-for-evidence/" target="_blank"&gt;May 2026 BioSlice Blog&lt;/a&gt;.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ec.europa.eu/newsroom/sante/newsletter-archives/75676" target="_blank"&gt;EUDAMED Registration Obligations Become Applicable&lt;/a&gt;&lt;/strong&gt;. On May 28, 2026, four of the six modules of the EUDAMED, the EU centralized database for medical devices and in vitro diagnostics, became mandatory. This triggered the application of certain transparency and registration obligations under the MDR and IVDR that had been deferred until those modules became mandatory. In particular, manufacturers (including non-EU manufacturers), importers, and EU authorized representatives are now required to register in EUDAMED, obtain a Single Registration Number (SRN), and register their devices in EUDAMED before placing them on the EU market. Devices already placed on the market before May 28 must be registered in EUDAMED by November 27, 2026. In addition, notified bodies are now required to upload certificate information to EUDAMED, and EU Member States must conduct certain market surveillance activities through EUDAMED. Read our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2025/11/new-medical-device-and-ivd-registration-and-transparency-requirements-to-apply-in-2026/" target="_blank"&gt;May 2026 BioSlice Blog&lt;/a&gt; for more details on the obligations.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.team-nb.org/artificial-intelligence-council-parliament-agree-to-simplify-and-streamline-rules/" target="_blank"&gt;&lt;strong&gt;Team-NB Publishes Statement on Provisional Agreement Reached by the Council and European Parliament on the Revised EU AI Rules&lt;/strong&gt;&lt;/a&gt;. Team-NB (the European association of notified bodies) clarified in their statement that the provisional agreement reached between the institutions does not alter the integrated conformity assessment procedure for AI-enabled medical devices under the AI Act, and that AI Act requirements would remain directly applicable to AI-enabled medical devices and IVDs alongside the MDR and the IVDR. Additionally, Team-NB raised concerns that the extended timelines for high risk AI obligations may be insufficient to allow for the designation of AI notified bodies and completion of conformity assessments. Team-NB further warned that delays in the adoption of implementing measures and harmonized standards could create capacity constraints and lead to inconsistent implementation of the AI Act across EU Member States for AI-enabled medical devices and IVDs.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.medtecheurope.org/2026/05/05/mdr-ivdr-revision-building-a-simpler-more-predictable-framework-for-patient-access-and-innovation/" target="_blank"&gt;MedTech Europe Publishes Position Paper on the Revisions of the EU MDR/IVDR&lt;/a&gt;&lt;/strong&gt;. In its position paper, MedTech Europe sets out that it broadly supports the proposed revisions to the MDR and IVDR, particularly the focus on simplification, risk-based oversight, and international cooperation. It also identifies several areas where further changes are needed, including a clear implementation process for integrating AI requirements into MDR and IVDR conformity assessment procedures and for consistent oversight of AI-enabled medical technologies within existing medical device market surveillance systems. In relation to software as a medical device, MedTech Europe supports the proposed amendments to the classification rules that would allow certain lower-risk software devices to remain classified as Class I. Read our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2025/12/from-complexity-to-clarity-how-the-eu-commission-plans-to-overhaul-the-mdr-and-ivdr/" target="_blank"&gt;December 2025 BioSlice Blog&lt;/a&gt; and our &lt;a href="/en/perspectives/advisories/2026/02/the-eu-medical-device-shake-up"&gt;February 2026 Advisory&lt;/a&gt;&amp;nbsp;for more details on the Commission&amp;rsquo;s proposals.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.cocir.org/position/targeted-revision-of-eu-mdr-rule-11-for-medical-device-software/" target="_blank"&gt;COCIR position paper on revisions to software medical device classification&lt;/a&gt;&lt;/strong&gt;. COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT, and electromedical industries, has published a position paper on the Commission&amp;rsquo;s proposal to revise MDR Rule 11 on the classification of medical device software. COCIR warns that several key terms remain too open to interpretation. In particular, it argues that the distinction between &amp;ldquo;informing&amp;rdquo; and &amp;ldquo;driving&amp;rdquo; clinical management in the proposal is unstable. The paper proposes alternative wording that it says addresses the challenges with the Commission&amp;rsquo;s proposals. COCIR suggests removing the words &amp;ldquo;confer a clinical benefit&amp;rdquo; from Rule 11, referring instead to whether the software is intended to &amp;ldquo;diagnose or treat patients without healthcare professional oversight.&amp;rdquo; It says the advantage of using health care professional oversight as a classification criterion is that it can be practically assessed, and it collapses the &amp;ldquo;semantically fragile &amp;lsquo;inform/drive&amp;rsquo; dichotomy&amp;rdquo; in the current proposal.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;UK&amp;rsquo;s MHRA and National AI Commission Share Views on the Regulation of AI in Health Care&lt;/strong&gt;. In a webinar on May 20, 2026, the two agencies outlined emerging views on a UK framework for regulating AI in health care. The discussion emphasized that AI challenges traditional medicines regulation given faster development, lower barriers to entry, and continuously evolving systems, and will require a more flexible regulatory framework with greater emphasis on post‑market monitoring and proportionate controls at market entry. Stakeholder engagement has highlighted four core priorities: ensuring safety and oversight; distinguishing between lower‑risk administrative uses and higher‑risk clinical applications; improving transparency and patient awareness; and establishing ongoing monitoring with clear accountability. The &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/groups/national-commission-into-the-regulation-of-ai-in-healthcare" target="_blank"&gt;National AI Commission&lt;/a&gt;&amp;lsquo;s recommendations are expected in autumn 2026, alongside further MHRA guidance on AI as a medical device.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/plan-to-enable-safe-ai-powered-innovation-in-health-and-social-care-research/" target="_blank"&gt;UK&amp;rsquo;s HRA Publishes Two‑Year Plan for Safe Use of AI in Health Research&lt;/a&gt;&lt;/strong&gt;. The UK Health Research Authority (HRA) has published a new two-year plan on how it will help researchers use AI and new technologies to improve patient care. The plan is structured around three priorities: (1) being clear where AI development, evaluation and implementation activities qualify as research, (2) clarifying the circumstances in which health information can be accessed using AI-enabled and data driven approaches to identify and contact people about research options relevant to them, and (3) taking action to ensure that review of AI-enabled and data-driven research is appropriately informed, rigorous and consistent. Each of these priority areas is supported by workstreams with certain deliverables; for example, the HRA intends to update, as first priority, the &amp;lsquo;is my study research&amp;rsquo; decision tool and supporting guidance that defines when AI activity is research. The HRA says these changes will make it simpler and faster to do health and social care research enabled by safe, AI-powered innovation.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://standardsdevelopment.bsigroup.com/projects/9026-13652" target="_blank"&gt;UK Consultation on New Standard for Digital Mental Health Technologies&lt;/a&gt;&lt;/strong&gt;. The MHRA has sponsored the British Standards Institution (BSI) to develop a new standard for digital mental health technologies. The BSI has now launched a consultation on the draft standard, which provides recommendations for performing studies to generate clinical evidence involving digital mental health technologies. The standard applies to the pre-market phase and real-world data in the early implementation post-market phase. It covers factors such as controls, sample characteristics, safety, effectiveness, engagement end points, and follow-up periods. The consultation is open until June 29, 2026.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62024CJ0604" target="_blank"&gt;Court of Justice of the European Union (CJEU) Rules on the Prohibition of Online Pharmacy Sales&lt;/a&gt;&lt;/strong&gt;. The CJEU has delivered a preliminary ruling in the case &lt;em&gt;FARMAKEIO YZ &amp;amp; SIA O.E. v. Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias&lt;/em&gt;. (C 604/24), clarifying the limits of EU Member States&amp;rsquo; discretion to restrict online sales of non prescription medicines under Article 85c of Directive 2001/83/EC. The case arose from Greek rules which, in practice, limited online sales of medicines to a narrow subcategory of over-the-counter medicinal products, effectively excluding most non prescription medicinal products. The CJEU held that such a restriction is incompatible with Article 85c(1) of Directive 2001/83/EC, which requires EU Member States to permit distance sales of non prescription medicinal products by authorized pharmacies, and the rules cannot be justified under Article 85c(2) on public health grounds because the conditions deprived Article 85(c)(1) of its effectiveness. The CJEU held that EU Member States may make a specific category of non-prescription medicinal products subject to conditions (for example, on account of their particular therapeutic characteristics) but only insofar as those conditions do not call into question the possibility of offering those medicinal products for sale.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.edqm.eu/en/-/new-council-of-europe-recommendation-sets-standards-for-remote-and-online-medicine-provision" target="_blank"&gt;Council of Europe Committee of Ministers Adopts Recommendation CM/Rec(2026)7 on the Remote and Online Provision of Medicine Products&lt;/a&gt;&lt;/strong&gt;. The recommendation sets out best practices for remote and online providers of medicinal products, non-pharmacy outlets (i.e., any retail business that is authorized to sell approved non-prescription medicinal products), EU Member States, and health care professional regulatory and representative bodies. Among other measures, it recommends that remote and online providers ensure that automated medicine-selection processes, including those using AI, be evaluated against relevant standards, regularly updated, and designed to ensure patient safety. It also recommends that non-pharmacy outlets take account of the limitations of the communication channels used when designing and delivering their services. While non-binding, the recommendation serves as a framework for EU Member States to consider and implement through national policies, legislation, and regulatory practice.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.edpb.europa.eu/system/files/2026-04/edpb_guidelines_202601_scientificresearch_en.pdf" target="_blank"&gt;&lt;/a&gt;&lt;strong&gt;&lt;a href="https://www.medtecheurope.org/resource-library/cybersecurity-act-revision-medtech-europes-response-to-the-public-consultation/" target="_blank"&gt;MedTech Europe Publishes Feedback on the European Commission Consultation on Revised EU Cybersecurity Act&lt;/a&gt;&lt;/strong&gt;. While broadly supporting the revision of the EU Cybersecurity Act, MedTech Europe calls for a more coherent and proportionate framework tailored to highly regulated sectors such as health care. In particular, they emphasized that, while strengthening the EU cybersecurity resilience is critical, any revised regime should avoid regulatory fragmentation and overlapping cybersecurity requirements for medical devices already regulated under the MDR and IVDR, while remaining practical for industry to implement. Given that medical technologies often rely on globally integrated supply chains (e.g., for software modules), MedTech Europe also called to prioritize international recognition of voluntary cybersecurity certification schemes and for the centralized EU-level publication of cybersecurity certification schemes to reduce fragmentation. Read our&lt;a href="/en/perspectives/publications/2026/02/virtual-and-digital-health-digest"&gt; January 2026 Digest&lt;/a&gt; for more details on the Commission proposal.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.medtecheurope.org/wp-content/uploads/2026/05/20260526_joint-industry-statement-on-digital-omnibus.pdf" target="_blank"&gt;MedTech Europe and Other Industry Associations Urge EU Member States to Preserve the Ambition of the Digital Omnibus&lt;/a&gt;&lt;/strong&gt;. Following the publication of the Council&amp;rsquo;s compromise texts on the Digital Omnibus, a coalition of industry associations, including MedTech Europe, expressed concerns that the direction of ongoing Council negotiations could undermine key simplification measures proposed by the European Commission as part of the Digital Omnibus in relation to the General Data Protection Regulation (GDPR), cybersecurity incident reporting, cookies, and the Data Act. In particular, the joint statement calls to maintain the Commission&amp;rsquo;s targeted amendments to the GDPR (including more workable conditions for the use of personal data for AI and an innovation-enabling definition of scientific research), support for an EU-wide single-entry point for cyber incident reporting, and a more innovation-friendly approach to data and cookie rules. The joint statement notes that certain elements of the Council&amp;rsquo;s compromise texts risk weakening the proposal&amp;rsquo;s simplification objectives and urges Member States to preserve the ambition of the Digital Omnibus as discussions on the Council&amp;rsquo;s position continue.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2026/05/one-month-to-go-what-businesses-need-to-know-to-meet-new-data-law/" target="_blank"&gt;DUAA Data Protection Complaints Requirement Takes Effect in UK&lt;/a&gt;&lt;/strong&gt;. On June 19, 2026, the data protection complaints handling requirement introduced by the Data (Use and Access) Act 2025 (DUAA) came into force (read our &lt;a href="/en/perspectives/advisories/2026/02/ico-publishes-guidance-on-how-to-deal-with-data-protection-complaints"&gt;February&amp;nbsp;2026 Advisory&lt;/a&gt;&amp;nbsp;for more details). From that date, all controllers must have a process in place to handle data protection complaints from anyone who is unhappy with how their personal information has been handled. Controllers must provide a way for people to make complaints directly to them; for example, via an electronic complaints form or a dedicated email address, and must acknowledge complaints within 30 days and respond without undue delay. This is the last major data protection provision of the DUAA to come into force, with most of the remaining provisions having commenced on February 5, 2026. The ICO updated its &lt;a rel="noopener noreferrer" href="https://ico.org.uk/for-organisations/how-to-deal-with-data-protection-complaints/" target="_blank"&gt;guidance on handling data protection complaints&lt;/a&gt; on May 8, 2026. Any business processing personal data in the UK that does not already have a formal complaints process in place should treat this as an immediate priority.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/ico-and-stakeholder-consultations/2026/03/ico-consultation-on-the-draft-guidance-about-automated-decision-making-including-profiling/" target="_blank"&gt;UK&amp;rsquo;s ICO Consults on Draft Guidance on Automated Decision-Making&lt;/a&gt;&lt;/strong&gt;. The ICO consultation on draft guidance about automated decision-making (ADM) closed on May 29, 2026. This serves to update existing guidance on automated decision-making and profiling, following the introduction of the Data (Use and Access) Act 2025. The draft guidance identifies three points when organizations must provide information about their ADM activities: when they first collect personal data; when individuals make a subject access request; and when they engage in ADM. It also notes the likely need to conduct a data protection impact assessment when engaging in ADM and emphasizes the importance of adequate mechanisms for diagnosing quality issues. Final guidance is expected in Summer 2026 and is directly relevant to life sciences companies deploying AI-enabled tools in clinical, diagnostic, or patient-facing contexts.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.edps.europa.eu/data-protection/our-work/publications/annual-reports/2026-05-07-annual-report-2025-protecting-people-changing-digital-world_en" target="_blank"&gt;European Data Protection Supervisor (EDPS) Publishes Its 2025 Annual Report&lt;/a&gt;&lt;/strong&gt;. The Annual Report highlights a year of increased regulatory activity, particularly in the area of AI. This includes the establishment of a dedicated AI Unit, which will serve as the market surveillance authority and notified body of the EU&amp;rsquo;s AI systems under the AI Act, the launch of an AI regulatory sandbox pilot project, and more scrutiny of international data transfers and large-scale IT systems. The report notes the growing regulatory focus on AI and data‑driven technologies, signaling heightened expectations around compliance, governance, and the handling of sensitive health data.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;a name="IP Updates"&gt;IP Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;&lt;span style="text-decoration: underline;"&gt;The UK Government Responds to House of Lords&amp;rsquo; Report on Copyright and AI&lt;/span&gt;&lt;/strong&gt;. On May 15, 2026, the UK government published its &lt;a rel="noopener noreferrer" href="https://committees.parliament.uk/publications/53047/documents/296552/default/" target="_blank"&gt;formal response&lt;/a&gt; to the House of Lords Communications and Digital Committee&amp;rsquo;s (CDC) &lt;a rel="noopener noreferrer" href="https://publications.parliament.uk/pa/ld5901/ldselect/ldcomm/267/267.pdf" target="_blank"&gt;report&lt;/a&gt; on copyright and AI and the UK government&amp;rsquo;s earlier&lt;a rel="noopener noreferrer" href="https://assets.publishing.service.gov.uk/media/69ba692226909a14239612e4/CP2602959_-_Report_on_Copyright_and_Artificial_Intelligence_web.pdf" target="_blank"&gt; report &lt;/a&gt;and impact assessment (see our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/05/virtual-and-digital-health-digest-april-2026/" target="_blank"&gt;April 2026 Digest&lt;/a&gt;). While the response largely reiterates the government&amp;rsquo;s existing position, it identifies four areas of near-term focus:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Digital replicas&lt;/strong&gt;: The government will launch a consultation this summer on protecting individuals against unauthorized digital replicas, recognizing that existing legal routes, including &amp;ldquo;passing off,&amp;rdquo; may offer limited protection, particularly for lesser-known artists.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Labeling&lt;/strong&gt;: &lt;strong&gt;A task force will be established to develop best practice proposals for labeling&lt;/strong&gt; AI-generated content, with an interim report expected in autumn 2026. The government acknowledges that voluntary measures alone may be insufficient.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Transparency&lt;/strong&gt;: The government will publish a review of mechanisms enabling creators to control the online use of their works, including standards, technical solutions and best practice transparency, with a view to identifying regulatory gaps.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Licensing support&lt;/strong&gt;: A working group will consider whether additional government assistance is needed to support smaller creative organizations in licensing their content and securing fair remuneration.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;On the broader question of copyright reform, the government reiterates that it will not introduce legislative change unless it is confident that reform would deliver tangible economic and societal benefits. It also stops short of definitively ruling out a broad text and data mining exception, despite the CDC&amp;rsquo;s recommendation to do so.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&lt;em&gt;Kuran Phull&amp;nbsp;is employed as a trainee solicitor at Arnold &amp;amp; Porter&amp;rsquo;s London office. Amalia is not admitted to the practice of law.&lt;br /&gt;
&lt;/em&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{4E6A10E7-D190-41B1-A7AF-6DEB6F85910D}</guid><link>https://globalcompetitionreview.com/hub/class-actions-hub/2025/article/caught-in-cost-benefit-analysis-cat-refuses-certification-in-salmon-collective-proceedings-behalf-of-consumers</link><a10:author><a10:name>Nicola Chesaites</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chesaites-nicola</a10:uri><a10:email>nicola.chesaites@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Naina Gupta</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gupta-naina</a10:uri><a10:email>naina.gupta@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alastair Brown</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brown-alastair</a10:uri><a10:email>alastair.brown@arnoldporter.com </a10:email></a10:author><title>Caught up in cost-benefit analysis: CAT refuses certification in Salmon collective proceedings on behalf of consumers</title><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{A363CC8F-06A7-4C99-AEF5-55C73D1F3773}</guid><link>https://globalcompetitionreview.com/hub/class-actions-hub/2025/article/cat-rules-against-class-representative-in-rail-boundary-fare-case-alleging-abuse-of-dominance</link><a10:author><a10:name>Alastair Brown</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brown-alastair</a10:uri><a10:email>alastair.brown@arnoldporter.com </a10:email></a10:author><a10:author><a10:name>Samuel Milucky</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/milucky-samuel</a10:uri><a10:email>samuel.milucky@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Naina Gupta</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gupta-naina</a10:uri><a10:email>naina.gupta@arnoldporter.com</a10:email></a10:author><title>CAT rules against class representative in rail boundary fare case alleging abuse of dominance</title><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{5EE682B8-59EA-43CA-B674-0693623484DC}</guid><link>https://globalcompetitionreview.com/hub/class-actions-hub/2025/article/supreme-court-provides-welcome-guidance-collective-proceedings-cat-and-court-of-appeal-odds</link><a10:author><a10:name>Naina Gupta</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gupta-naina</a10:uri><a10:email>naina.gupta@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Samuel Milucky</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/milucky-samuel</a10:uri><a10:email>samuel.milucky@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alastair Brown</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brown-alastair</a10:uri><a10:email>alastair.brown@arnoldporter.com </a10:email></a10:author><title>Supreme Court provides welcome guidance on collective proceedings as CAT and Court of Appeal at odds</title><pubDate>Mon, 29 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{D093E4F5-83A7-46B0-911E-538647D22114}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/staying-current-on-payments-for-consumer-products-retail-companies</link><a10:author><a10:name>Meredith Osborn</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/osborn-meredith</a10:uri><a10:email>meredith.osborn@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><title>Staying Current on Payments for Consumer Products &amp; Retail Companies</title><description>Join Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products &amp;amp; Retail industry group for the next program in our Consumer Products &amp;amp; Retail Navigator webinar series, focused on the latest legislative and regulatory developments shaping payments for consumer products and retail companies.</description><pubDate>Thu, 25 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Join Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products &amp;amp; Retail industry group for the next program in our Consumer Products &amp;amp; Retail Navigator webinar series, focused on the latest legislative and regulatory developments shaping payments for consumer products and retail companies.&lt;/p&gt;
&lt;p&gt;New laws and enforcement activity are moving quickly across the payments landscape &amp;mdash; from digital assets and buy now/pay later programs to gift card regulations and consumer protection requirements. Companies that sell to consumers or manage payment programs need to understand how these changes affect their compliance obligations and day-to-day business decisions.&lt;/p&gt;
&lt;p&gt;During our program, we will walk through what&amp;rsquo;s changing in payments law and what to do about it, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The GENIUS Act&lt;/li&gt;
    &lt;li&gt;California&amp;rsquo;s Digital Financial Assets Law&lt;/li&gt;
    &lt;li&gt;Gift card regulations including updated California legal requirements&lt;/li&gt;
    &lt;li&gt;New York&amp;rsquo;s FAIR Act, containing significant changes to NY&amp;rsquo;s consumer protection laws&lt;/li&gt;
    &lt;li&gt;Legislative and enforcement developments in buy-now-pay-later&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{C8B0A02E-A68E-4249-916D-82A90B42B02F}</guid><link>https://www.fdli.org/2026/06/fda-process-101-an-essential-toolkit-for-practicing-in-fda-regulated-products-areas/</link><author>claire.dennis@arnoldporter.com</author><title>FDA Process 101: An Essential Toolkit for Practicing in FDA-Regulated Products Areas</title><pubDate>Thu, 25 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{066622C6-3C9A-4781-9D28-0AF7BA3D50E3}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/synapse-arnold-porters-pharma-law-day-2026</link><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>George Jenkins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jenkins-george</a10:uri><a10:email>george.jenkins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Axel Gutermuth</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gutermuth-axel</a10:uri><a10:email>axel.gutermuth@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Niels Christian Ersbøll</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/ersbll-niels-christian</a10:uri><a10:email>niels.ersboll@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><title>Synapse: Arnold &amp; Porter’s Pharma Law Day 2026</title><description>Join us on June 24 at The Circle in Z&amp;uuml;rich for the second edition of Synapse, a focused day of discussion on the most consequential EU, UK and U.S. regulatory and enforcement developments in life sciences, designed for senior in-house counsel navigating complex strategic decisions.</description><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Join us on June 24 at The Circle in Z&amp;uuml;rich for the second edition of Synapse, a focused day of discussion on the most consequential EU, UK and U.S. regulatory and enforcement developments in life sciences, designed for senior in-house counsel navigating complex strategic decisions.&lt;/p&gt;
&lt;p&gt;The programme brings together Arnold &amp;amp; Porter's life sciences practitioners across Europe and the U.S., in a format built for substantive exchange and a practical and direct approach, addressing the regulatory and enforcement pressures that matter most to your business right now.&lt;/p&gt;
&lt;p&gt;We would be delighted to welcome you on June 24.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C1343BC8-7050-4E7D-8D9C-5E7E7F3A4AB2}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/irs-announces-interpretation-of-the-expanded-group-of-nonprofit-employees-subject-to</link><a10:author><a10:name>Douglas S. Pelley</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pelley-douglas-s</a10:uri><a10:email>Douglas.Pelley@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kathleen Wechter</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wechter-kathleen</a10:uri><a10:email>kathleen.wechter@arnoldporter.com</a10:email></a10:author><title>IRS Announces Interpretation of the Expanded Group of Nonprofit Employees Subject to Compensation Limitations Under Section 4960</title><description>Under Section 4960 of the Internal Revenue Code, a nonprofit organization is generally subject to a 21% excise tax on&amp;nbsp; compensation paid to &amp;ldquo;covered employees&amp;rdquo; in excess of $1 million in any year (and on certain severance and similar &amp;ldquo;parachute payments&amp;rdquo; exceeding a defined threshold).&amp;nbsp; Prior to the One Big Beautiful Bill (OBBB), &amp;ldquo;covered employees&amp;rdquo; were generally limited to (i) an organization&amp;rsquo;s top-five most highly compensated employees for the taxable year, and (ii) anyone who was a &amp;ldquo;covered employee&amp;rdquo; in a prior taxable year.&amp;nbsp;</description><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Under Section 4960 of the Internal Revenue Code, a nonprofit organization is generally subject to a 21% excise tax on  compensation paid to &amp;ldquo;covered employees&amp;rdquo; in excess of $1 million in any year (and on certain severance and similar &amp;ldquo;parachute payments&amp;rdquo; exceeding a defined threshold).  Prior to the One Big Beautiful Bill (OBBB), &amp;ldquo;covered employees&amp;rdquo; were generally limited to (i) an organization&amp;rsquo;s top-five most highly compensated employees for the taxable year, and (ii) anyone who was a &amp;ldquo;covered employee&amp;rdquo; in a prior taxable year. Effective for 2026 and beyond, the OBBB enacted a significant expansion of the definition of &amp;ldquo;covered employee&amp;rdquo; to generally include all current and former employees since 2017.&lt;/p&gt;
&lt;p&gt;In Notice 2026-36 the IRS announced how it intends to interpret the changes made by the OBBB to the definition of a &amp;ldquo;covered employee&amp;rdquo; in proposed regulations, which are favorable to nonprofits. First, the IRS will take a narrow view of the OBBB lookback rule for the period from 2017 through 2025 for determining &amp;ldquo;covered employees&amp;rdquo; for 2026 and beyond.  Rather than include as a &amp;ldquo;covered employee&amp;rdquo; anyone who was employed by the organization during that timeframe, as the language of the OBBB suggests, the IRS stated that  for years 2017 through 2025 it will only include persons who would have qualified as &amp;ldquo;covered employees&amp;rdquo; during that period under pre-OBBB law (including pre-OBBB Treasury Regulations and its exceptions).  Second, the IRS anticipates that the proposed regulations will carry over the existing regulatory exceptions for &amp;ldquo;limited hours&amp;rdquo; and &amp;ldquo;nonexempt funds,&amp;rdquo; but will not include the &amp;ldquo;limited services&amp;rdquo; exception (which is not expected to apply under the OBBB changes). &lt;/p&gt;
&lt;p&gt;The Notice states that taxpayers may rely on the interpretations set forth in the Notice until proposed regulations are issued. &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D1765DFB-55DD-4EA9-8C46-819E56F9C37F}</guid><link>https://www.fdli.org/2026/06/the-rise-of-big-food-litigation/</link><author>jocelyn.wiesner@arnoldporter.com</author><title>The Rise of Big Food Litigation: Is a Landmark Decision in Pennsylvania Only the Beginning?</title><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{AE65FCAC-1197-407B-93D7-25C0B871E74F}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/fda-issues-revised-draft-guidance-on-demonstrating-substantial-evidence-of-effectiveness</link><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Catherine A. Brandon</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brandon-catherine-a</a10:uri><a10:email>Catherine.Brandon@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Claire W. Dennis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dennis-claire</a10:uri><a10:email>claire.dennis@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jonathan Trinh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trinh-jonathan</a10:uri><a10:email>Jonathan.Trinh@arnoldporter.com</a10:email></a10:author><title>FDA Issues Revised Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products</title><description>On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States. As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development.</description><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.[[N: U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., &lt;a rel="noopener noreferrer" href="https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf" target="_blank"&gt;&lt;em&gt;Operation TrialBlazer&lt;/em&gt;&lt;/a&gt; (June 2026); U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., Press Release, &lt;a rel="noopener noreferrer" href="https://www.hhs.gov/press-room/hhs-launches-clinical-trials-reform-initiative.html" target="_blank"&gt;&lt;em&gt;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials&lt;/em&gt;&lt;/a&gt; (June 22, 2026).&amp;nbsp;]] As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;proposing a pilot program intended to reduce the start-up time for first-in-human (FIH) clinical trials (see &lt;a href="/en/perspectives/advisories/2026/06/fda-proposes-expedited-investigational-new-drug-pilot-program"&gt;Arnold &amp;amp; Porter&amp;rsquo;s Advisory&lt;/a&gt;);&lt;/li&gt;
    &lt;li&gt;clarifying the chemistry, manufacturing, and controls (CMC) expectations for Investigational New Drug (IND) submissions to help sponsors efficiently generate and submit the phase-appropriate data needed to support phase 1 clinical trials; and&lt;/li&gt;
    &lt;li&gt;issuing a significantly revised draft of FDA&amp;rsquo;s critical Substantial Evidence Guidance, which sets out regulatory expectations for sponsors regarding the type and quantity of data and information necessary to meet the statutory standard for &amp;ldquo;substantial evidence&amp;rdquo; of effectiveness in support of a drug or biological product application, as discussed herein.[[N: Other FDA initiatives include adopting a risk-based approach toward nonclinical safety studies to relieve certain sponsors from conducting unnecessary animal testing, as well as evaluating strategies to minimize protocol amendments and ensure that protocol amendments do not delay clinical trials from continuing. &lt;em&gt;Operation TrialBlazer&lt;/em&gt;, at 10-11 and 14; U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development" target="_blank"&gt;&lt;em&gt;FDA Actions to Accelerate and Modernize Early and Late Stage Clinical Development&lt;/em&gt;&lt;/a&gt; (June 22, 2026); U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-chemistry-manufacturing-and-control-cmc-information" target="_blank"&gt;&lt;em&gt;IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information&lt;/em&gt;&lt;/a&gt; (updated June 22, 2026).&amp;nbsp;]]&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;The HHS Office of Inspector General is also evaluating whether to update the safe harbor regulations under the federal Anti-Kickback Statute, or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries to address remuneration provided to individuals in connection with their participation in clinical trials.[[N:&amp;nbsp;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials; Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, 91 Fed. Reg. 37902, 37903 (June 24, 2026).]]&lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s revised draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (the &amp;ldquo;2026 Draft Substantial Evidence Guidance&amp;rdquo;), substantially revises FDA&amp;rsquo;s December 2019 draft guidance of the same name, which itself was an update to FDA&amp;rsquo;s 1998 guidance on the same topic.[[N: U.S. Food &amp;amp; Drug Admin., &lt;em&gt;Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry&lt;/em&gt;, at 1 (June 2026) (&amp;ldquo;2026 Draft Substantial Evidence Guidance&amp;rdquo;); U.S. Food &amp;amp;&amp;nbsp;Drug Admin., &lt;em&gt;Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry&lt;/em&gt;, at 1 (Dec. 2019); U.S. Food &amp;amp; Drug Admin., &lt;em&gt;Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products: Guidance for Industry&lt;/em&gt;, at 1 (May 1998). When finalized, the 2026 Draft Substantial Evidence Guidance will replace the 1998 Guidance.]] The 2026 Draft Substantial Evidence Guidance reframes how sponsors should plan to meet the &amp;ldquo;substantial evidence&amp;rdquo; standard for demonstrating effectiveness.[[N: 21 U.S.C. &amp;sect; 355(d).]] In particular, it shifts focus from the previous default posture of two &amp;ldquo;adequate and well-controlled investigations&amp;rdquo;[[N: &lt;em&gt;Id&lt;/em&gt;. (emphasis added).]] onto what had been considered the exception to that general requirement: a single adequate and well-controlled clinical investigation with confirmatory evidence.[[N: &lt;em&gt;Id&lt;/em&gt;.]]&lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s rewrite is intended to &amp;ldquo;clarify circumstances in which drug developers may be able to rely on data from one adequate and well-controlled pivotal clinical investigation with confirmatory evidence, to demonstrate substantial evidence of effectiveness for drug approval.&amp;rdquo;[[N: U.S. Food &amp;amp; Drug Admin., Fact Sheet, &lt;a rel="noopener noreferrer" href="https://www.fda.gov/media/193225/download?attachment" target="_blank"&gt;FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development&lt;/a&gt;]] In so doing, the 2026 Draft Substantial Evidence Guidance appears to:&amp;nbsp;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Broaden the circumstances in which a single pivotal trial strategy with confirmatory evidence would be expected to meet the standard for substantial evidence of effectiveness in support of a marketing application &amp;mdash; and thus potentially shift the burden onto FDA to justify requiring a second trial;&lt;/li&gt;
    &lt;li&gt;Clarify that confirmatory evidence can come from several sources, including related adequate and well-controlled trial data, data supporting a related indication for the same drug, evidence from other approved drugs in the same pharmacologic class, mechanistic and biological information, early-phase clinical data, natural history or registry data, and other external information;&lt;/li&gt;
    &lt;li&gt;Explain that confirmatory evidence must be strong enough &amp;mdash; and from a reliable enough source &amp;mdash; to yield the confirmatory evidence that a second adequate and well-controlled trial otherwise would have done;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Focus FDA&amp;rsquo;s confirmatory evidence analysis on the strength of the evidence as determined by trial design, conduct, prespecified analysis, endpoint selection, results, data missingness, consistency across endpoints and subgroups, and the overall development program; and&lt;/li&gt;
    &lt;li&gt;Describe FDA&amp;rsquo;s revised policy regarding flexibility in statistical analysis, including recognition that a p-value greater than a one-sided 0.025 threshold may be acceptable in some circumstances, while also warning that a one-sided 0.025 threshold may be insufficient where the pretrial probability of effectiveness is low.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance also signals a preference for clinical endpoints when possible, stating that &amp;ldquo;[u]se of a clinical endpoint is preferred when feasible&amp;rdquo;; use of a surrogate endpoint is relegated to &amp;ldquo;[a]n alternative approach.&amp;rdquo;[[N: 2026 Draft Substantial Evidence Guidance at 5.]] If maintained in final guidance, this could signal a more general shift in FDA&amp;rsquo;s thinking on accelerated approval.&lt;/p&gt;
&lt;h2&gt;Background: The Substantial Evidence of Effectiveness Standard&lt;/h2&gt;
&lt;p&gt;As detailed in &lt;a href="/en/perspectives/advisories/2026/02/fda-advances-a-plausible-mechanism-framework-for-rare-disease-drug-development-and-shifts-to"&gt;Arnold &amp;amp; Porter&amp;rsquo;s prior Advisory&lt;/a&gt;, section 505(d) of the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act) requires &amp;ldquo;substantial evidence&amp;rdquo; of effectiveness for approval of a drug. The statutory definition refers to adequate and well-controlled investigations by qualified experts. It provides that, if FDA determines based on relevant science that &amp;ldquo;data from one adequate and well-controlled clinical investigation and confirmatory evidence&amp;rdquo; are sufficient to establish effectiveness, FDA may consider that data and evidence to constitute substantial evidence.[[N: 21 U.S.C. &amp;sect; 355(d).]]&lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s implementing regulations explain that investigations should be adequate and well-controlled to be able to distinguish the effect of a drug from other influences, such as spontaneous change in the disease, placebo effect, or biased observation.[[N: 21 C.F.R. &amp;sect; 314.126.]] The regulations also identify study design features that ordinarily will be considered adequate and well-controlled: a clear protocol, appropriate controls, methods of patient selection and assignment that minimize bias, methods to minimize subject and observer bias, well-defined and reliable response measures, and adequate analytical methods.[[N: &lt;em&gt;Id&lt;/em&gt;. &amp;sect; 314.126(a), (b).]]&lt;/p&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance does not purport to alter the statutory or regulatory standard. But it is significant insofar as it describes how, when finalized, FDA intends to interpret and apply the statutory standard in a way that differs from historical practice (even if a large swath of drugs already have been approved in reliance on a single trial with confirmatory evidence). This is particularly telling when read against FDA&amp;rsquo;s broader, recent theme of emphasizing the quality, relevance, and biological coherence of the evidence package rather than insisting on multiple pivotal trials in every application.[[N: In their 2025 New England Journal of Medicine article on FDA&amp;rsquo;s &amp;ldquo;plausible mechanism pathway,&amp;rdquo; then-FDA Commissioner Makary and then-CBER Director Prasad described a framework for certain individualized therapies where randomized trials may not be feasible and where effectiveness may be supported by a well-characterized disease biology, a therapy that targets the underlying abnormality, evidence that the target was successfully drugged or edited, natural history information, and improvement in clinical outcomes or disease course. Vinay Prasad &amp;amp; Martin A. Makary, FDA&amp;rsquo;s New Plausible Mechanism Pathway, 393 New Eng. J. Med. 2365 (2025).]]&lt;/p&gt;
&lt;h2&gt;A Single Trial with Confirmatory Evidence as the New Default&lt;/h2&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance puts the FD&amp;amp;C Act&amp;rsquo;s single-trial-with-confirmatory-evidence language at the center of development planning. According to the 2026 Draft Substantial Evidence Guidance, FDA will consider the design, conduct, analysis, and persuasiveness of the single trial; the source and strength of the confirmatory evidence; disease-specific considerations such as seriousness, unmet need, and prevalence; and whether more than one adequate and well-controlled trial would be ethical and practicable.&amp;nbsp; Thus, sponsors should be prepared to explain, before initiating the single pivotal trial, why the proposed clinical investigation is adequate and well-controlled and why the proposed confirmatory evidence is sufficient.&amp;nbsp; Additional trials may be required when a single trial is not sufficiently representative, or where more evidence is needed to support the safety or benefit-risk calculus &amp;mdash; though FDA appears poised to consider those situations the exception rather than the rule, and the draft guidance notes that in some situations a convincingly positive, well-conducted trial showing a substantial decrease in mortality may make a second trial impractical or unethical.[[N: 2026 Draft Substantial Evidence Guidance at 9, 11-12.]]&lt;/p&gt;
&lt;p&gt;FDA recommends sponsors discuss their proposed approach to demonstrating substantial evidence early in development, including at a pre-IND meeting and no later than at the end of phase 2. Sponsors should be prepared to present the proposed trial design, the confirmatory evidence package, the legal basis for any reliance on external or third-party evidence, and the statistical rationale.[[N: &lt;em&gt;Id&lt;/em&gt;. at 2, 9.]]&lt;/p&gt;
&lt;h2&gt;Strength of the Single Trial&lt;/h2&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance sets forth an expectation that to support approval, the single pivotal trial will be particularly persuasive, such that it can carry most of the evidentiary weight of &amp;ldquo;substantial evidence.&amp;rdquo;[[N: &lt;em&gt;Id&lt;/em&gt;. at 8-9, 11-12.&amp;nbsp; The more limited or indirect that confirmatory evidence is, the more persuasive the pivotal trial will need to be.]] This means that the trial must be generalizable to U.S. clinical practice, reflective of a broad and representative population across multiple sites, include a control arm and supportive therapies that reflect the current standard of care, and utilize a clinically meaningful primary endpoint. FDA identifies multiple factors that affect whether the evidence can support a fair and responsible expert conclusion about effectiveness. These factors include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;em&gt;Trial design&lt;/em&gt;. FDA focuses on the control group, randomization, blinding, endpoint selection, eligibility criteria, site selection, representativeness, the standard of care, and whether the design is appropriate for the clinical question. The single trial must also be sufficiently powered to convincingly demonstrate an effect.&amp;nbsp;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Trial conduct&lt;/em&gt;. FDA emphasizes data quality, adherence to treatment and protocol, completeness of follow-up, minimization of bias, and the effect of missing data.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Analysis plan&lt;/em&gt;. FDA expects prespecification, control of type I error where applicable, appropriate estimands, sensitivity analyses, and well-justified frequentist or Bayesian methods.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Trial results&lt;/em&gt;. FDA will consider statistical persuasiveness, clinical meaningfulness, magnitude of effect, uncertainty, consistency across endpoints and subgroups, and robustness to analysis assumptions.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Overall development program&lt;/em&gt;. FDA will evaluate the pivotal trial in light of early-phase data, external information, dose and mechanism information, any inconsistent data, and all relevant adequate and well-controlled trials.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;To ensure sufficient strength, sponsors should endeavor to also build into the single trial (and the related statistical analysis plan) prespecified supportive secondary endpoints, as well as supportive results across important subsets, high-quality conduct, comprehensive follow-up, minimal data missingness, and robustness of assumptions. Sponsors also should identify any potentially inconsistent evidence early; an adequate and well-controlled trial showing no effect, or even harm, with confidence intervals that rule out meaningful effects, could call into question positive results from other trials unless there is a clear and compelling explanation for the difference.[[N: &lt;em&gt;Id&lt;/em&gt;.]]&lt;/p&gt;
&lt;h2&gt;Options for Confirmatory Evidence&amp;nbsp;&lt;/h2&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance also lays out several options that FDA may find persuasive as confirmatory evidence to support data from a single trial:&amp;nbsp;&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;em&gt;Related adequate and well-controlled trial data&lt;/em&gt;. FDA generally expects strong confirmatory evidence to come from related trials in related diseases or conditions or for related products. For an already-approved drug, FDA explains that a single pivotal trial may be supported by the adequate and well-controlled trials that supported approval for a different but closely related indication. FDA identifies the degree of similarity in disease pathophysiology, mechanism of action, and efficacy endpoints as critical considerations.[[N:&lt;em&gt; Id&lt;/em&gt;. at 9-10.]]&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Adequate and well-controlled trials demonstrating the effectiveness of other approved drugs in the same pharmacologic class&lt;/em&gt;. Here, the strength and relevance of the confirmatory evidence will depend on factors such as the similarity of the mechanism of action, whether similar endpoints were measured, the consistency of effects across the class, whether the new drug has similar effects, and the number of approved drugs in the class.[[N: &lt;em&gt;Id&lt;/em&gt;. at 10 n.34.]] This could be particularly beneficial for sponsors in competitive drug classes where FDA is more likely to accept existing data as persuasive confirmatory evidence.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Natural history and other external information&lt;/em&gt;. Natural history or registry data may serve as confirmatory evidence in appropriate circumstances, particularly where the clinical course without treatment is well characterized, and the treated trial result is difficult to attribute to bias or random variation. Early-phase information supporting the drug&amp;rsquo;s mechanism and dose, external information about disease pathophysiology and natural history, effects of the drug in related diseases, and effects of drugs with similar mechanisms of action can all help to support FDA&amp;rsquo;s expectation that the drug will be effective.[[N: &lt;em&gt;Id&lt;/em&gt;. at 8-9, 16.]]&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;FDA appears to recognize that its recommendation of reliance on other approved NDAs and BLAs raises important legal questions, and the Agency notes that reliance on data concerning a different drug may raise legal and regulatory concerns.[[N: &lt;em&gt;Id&lt;/em&gt;. at 10 n.34.]] If an NDA applicant does not own or have a right of reference to the other drug&amp;rsquo;s data, reliance on FDA&amp;rsquo;s prior finding of safety and effectiveness will convert the application into a 505(b)(2) application and trigger associated patent-certification and exclusivity considerations.[[N: 21 U.S.C.&amp;nbsp; &amp;sect; 355(b)(2).]] And importantly, for biological products (for which there is no pathway comparable to a 505(b)(2)), FDA reiterates its long-standing policy that a section 351(a) applicant must include all of the data and information necessary for approval in the Biologics License Application (BLA). In the alternative, FDA explains that to rely on a prior determination of safety, purity, and potency for another biological product to support approval, the applicant would need to submit a biosimilar BLA and otherwise meet the requirements to demonstrate biosimilarity.[[N: 42 U.S.C. &amp;sect; 262(k).]] (As an aside, we cannot help but note the tension between FDA&amp;rsquo;s position here &amp;mdash; that sponsors may not rely on prior knowledge to support a BLA without a right of reference &amp;mdash; and FDA&amp;rsquo;s draft guidance, &lt;em&gt;Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing&lt;/em&gt;, which appears to encourage sponsors to use relevant prior knowledge, including knowledge from previous clinically studied products, to support development of genome-editing gene therapy biological products.)[[N: U.S. Food &amp;amp; Drug Admin., &lt;em&gt;Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing Draft Guidance&lt;/em&gt;, at 2-3, 18-19 (June 2026).]] Stakeholders may wish to ask FDA to distinguish clearly between reliance on published or public scientific knowledge to support a scientific inference and legal reliance on another sponsor&amp;rsquo;s proprietary data or FDA&amp;rsquo;s prior approval finding.&lt;/p&gt;
&lt;h2&gt;The Revised Draft Guidance Offers Statistical Flexibility&lt;/h2&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance also incorporates a more flexible approach to statistical analysis, explaining that the overall persuasiveness of a trial&amp;rsquo;s results may be influenced by the magnitude of the p-value, or by alternative measures such as the posterior probability of effectiveness in a Bayesian analysis, as well as by the magnitude and clinical meaningfulness of the effect on the primary endpoint. FDA also notes that a statistically significant result in a large trial may not be clinically meaningful. At the same time, even small effects may be clinically meaningful when the effect is on survival or irreversible morbidity. To that end, the 2026 Draft Substantial Evidence Guidance explains that the appropriate significance level will depend on the prior, or pretrial, probability that the drug is effective. Where the prior probability is low, a single trial using the common one-sided 0.025 significance level may not adequately limit the probability of false-positive effectiveness conclusions. Conversely, in other circumstances, including where prior knowledge or strong confirmatory evidence increases confidence in effectiveness, FDA indicates that a p-value greater than one-sided 0.025 may be acceptable as part of the totality of evidence.[[N: 2026 Draft Substantial Evidence Guidance at 8, 11, 15.]]&lt;/p&gt;
&lt;p&gt;Sponsors considering statistical flexibility should seek alignment with FDA early, build the rationale into the protocol and statistical analysis plan, and explain how the proposed approach satisfies the statutory function of substantial evidence. Commenters may wish to ask FDA to provide examples to illustrate when FDA would accept a less stringent or more stringent threshold and how Bayesian operating characteristics should be calibrated in single-trial-with-confirmatory-evidence programs.&lt;/p&gt;
&lt;h2&gt;Other Points of Interest&lt;/h2&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;em&gt;Animal Rule is beyond the scope of the Revised Guidance&lt;/em&gt;. FDA expressly excludes Animal Rule approvals from the scope of the 2026 Draft Substantial Evidence Guidance.[[N: &lt;em&gt;Id&lt;/em&gt;. at 9 n.33.]] The Animal Rule regulations permit reliance on animal studies to establish effectiveness for certain products when human efficacy studies are not ethical or feasible. Still, FDA states that those regulations and related considerations are beyond the scope of this draft guidance.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Accelerated approval and surrogate endpoints&lt;/em&gt;. As noted above, the 2026 Draft Substantial Evidence Guidance states that the use of a clinical endpoint is preferred when feasible and that the use of a surrogate endpoint requires appropriate scientific justification linking the drug's effects on the surrogate endpoint to its effects on a relevant clinical endpoint. It also recognizes that surrogate endpoints reasonably likely to predict clinical benefit can support accelerated approval when statutory criteria are met, while validated surrogate endpoints can support traditional approval.[[N: &lt;em&gt;Id&lt;/em&gt;. at 5-6.]] Sponsors should consider whether to comment on how the single-trial-with-confirmatory-evidence framework applies to accelerated approval programs, particularly where the pivotal evidence rests on a surrogate or intermediate clinical endpoint.&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Relationship to plausible mechanism pathway&lt;/em&gt;. The 2026 Draft Substantial Evidence Guidance&amp;rsquo;s connection to FDA&amp;rsquo;s &lt;em&gt;Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause Draft Guidance&lt;/em&gt; (&amp;ldquo;Plausible Mechanism Draft Guidance&amp;rdquo;) is also notable.[[N: &lt;em&gt;Id&lt;/em&gt;. at 10 n.34, 13 n.38; U.S. Food &amp;amp; Drug Admin., &lt;em&gt;Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause: Draft Guidance for Industry&lt;/em&gt;, at 1-2, 5-6 (Feb. 2026) (&amp;ldquo;Plausible Mechanism Draft Guidance&amp;rdquo;).]] In that separate draft guidance, FDA proposed recommendations for individualized therapies targeting specific genetic conditions with known biological causes, including genome editing and RNA-based therapies for very small patient populations.[[N: Plausible Mechanism Draft Guidance at 1-2.]] The revised substantial evidence guidance places that framework within the broader concept of regulatory flexibility, though sponsors may wish to consider commenting on how mechanistic evidence, biological plausibility, and early clinical evidence can be used outside the narrow individualized-therapy context.&lt;/li&gt;
&lt;/ol&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The 2026 Draft Substantial Evidence Guidance gives direction on how FDA intends to operationalize the default use of a single trial with confirmatory evidence to meet &amp;ldquo;substantial evidence.&amp;rdquo;&amp;nbsp; It also leaves a number of open questions and room for commenters to influence the final guidance. In particular, stakeholders may wish to comment on the following topics, among others.&amp;nbsp;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;When a single adequate and well-controlled trial will be considered &amp;ldquo;highly persuasive,&amp;rdquo; including whether FDA will provide therapeutic-area-specific examples.&lt;/li&gt;
    &lt;li&gt;The boundary between permissible scientific reliance on public or platform knowledge and legal reliance on another sponsor&amp;rsquo;s data or FDA&amp;rsquo;s prior findings, particularly for 351(a) BLAs.&lt;/li&gt;
    &lt;li&gt;Whether FDA&amp;rsquo;s preference for clinical endpoints foreshadows disfavored use of accelerated approval, which has been an important approach to achieving patient access to new therapies for several decades.&lt;/li&gt;
    &lt;li&gt;Examples of statistical flexibility, including when a p-value greater than one-sided 0.025 may be acceptable and when a more stringent threshold may be expected.&lt;/li&gt;
    &lt;li&gt;Expectations for multiregional or largely ex-U.S. trials, including what FDA views as a sufficient number of U.S. patients and how sponsors can bridge representativeness gaps.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;If you have any questions, would like more information, or would like to discuss submitting a comment to FDA&amp;rsquo;s 2026 Draft Substantial Evidence Guidance (by September 22, 2026), FDA&amp;rsquo;s Request for Information (RFI) on the Expedited Investigational New Drug Pilot program (by July 22, 2026), or HHS Office of Inspector General&amp;rsquo;s RFI (by August 24, 2026), please reach out to one of the authors of this Advisory or your existing Arnold &amp;amp; Porter contacts.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{FB443933-A262-48CE-8A92-5F0BE0352EB0}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/fda-proposes-expedited-investigational-new-drug-pilot-program</link><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mahnu V. Davar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/davar-mahnu-v</a10:uri><a10:email>mahnu.davar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abeba Habtemariam</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/habtemariam-abeba</a10:uri><a10:email>Abeba.Habtemariam@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Catherine A. Brandon</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brandon-catherine-a</a10:uri><a10:email>Catherine.Brandon@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jonathan Trinh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trinh-jonathan</a10:uri><a10:email>Jonathan.Trinh@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Claire W. Dennis</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dennis-claire</a10:uri><a10:email>claire.dennis@arnoldporter.com</a10:email></a10:author><title>FDA Proposes Expedited Investigational New Drug Pilot Program to Drive Early Phase Clinical Research in the United States</title><description>&lt;p&gt;On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.[[N:U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf" target="_blank"&gt;Operation TrialBlazer&lt;/a&gt;&lt;/em&gt; (June 2026); U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., Press Release, &lt;em&gt;&lt;a href="https://www.hhs.gov/press-room/hhs-launches-clinical-trials-reform-initiative.html"&gt;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials&lt;/a&gt;&lt;/em&gt; (June 22, 2026).]] As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including:&lt;/p&gt;</description><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.[[N:U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf" target="_blank"&gt;Operation TrialBlazer&lt;/a&gt;&lt;/em&gt; (June 2026); U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., Press Release, &lt;em&gt;&lt;a href="https://www.hhs.gov/press-room/hhs-launches-clinical-trials-reform-initiative.html"&gt;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials&lt;/a&gt;&lt;/em&gt; (June 22, 2026).]] As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt; proposing a pilot program intended to reduce the start-up time for first-in-human (FIH) clinical trials, as discussed herein; &lt;/li&gt;
    &lt;li&gt; clarifying the chemistry, manufacturing, and controls (CMC) expectations for Investigational New Drug (IND) submissions to help sponsors efficiently generate and submit the phase-appropriate data needed to support phase 1 clinical trials; and &lt;/li&gt;
    &lt;li&gt;issuing a significantly revised draft of FDA&amp;rsquo;s critical Substantial Evidence Guidance that sets out regulatory expectations for sponsors regarding the type and quantity of data and information necessary to meet the statutory standard for &amp;ldquo;substantial evidence&amp;rdquo; of effectiveness in support of a drug or biological product application (see &lt;a href="/en/perspectives/advisories/2026/06/fda-issues-revised-draft-guidance-on-demonstrating-substantial-evidence-of-effectiveness"&gt;Arnold &amp;amp; Porter&amp;rsquo;s Advisory, here&lt;/a&gt;).[[N:Other FDA initiatives include adopting a risk-based approach toward nonclinical safety studies to relieve certain sponsors from conducting unnecessary animal testing, as well as evaluating strategies to minimize protocol amendments and ensure that protocol amendments do not delay clinical trials from continuing. Operation TrialBlazer, at 8-11 and 14; U.S. Food &amp;amp; Drug Admin., &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development" target="_blank"&gt;FDA Actions to Accelerate and Modernize Early and Late Stage Clinical Development&lt;/a&gt;&lt;/em&gt; (June 22, 2026); U.S. Food &amp;amp; Drug Admin., &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-chemistry-manufacturing-and-control-cmc-information" target="_blank"&gt;IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information&lt;/a&gt;&lt;/em&gt; (updated June 22, 2026).]]&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;The HHS Office of Inspector General is also evaluating whether to update the safe harbor regulations under the federal Anti-Kickback Statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries for remuneration provided to individuals in connection with their participation in clinical trials.[[N:&lt;em&gt;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials&lt;/em&gt;; Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, 91 Fed. Reg. 37902, 37903 (June 24, 2026).]]&lt;/p&gt;
&lt;p&gt;HHS estimates that Operation TrialBlazer could cut in half the time it takes to conduct clinical trials in the U.S.[[N:Robert F. Kennedy, Jr. (@SecKennedy), &lt;a href="https://x.com/SecKennedy/status/2069216603925786646"&gt;&lt;em&gt;Today, HHS launched a historic department-wide effort to strengthen America&amp;rsquo;s clinical research enterprise and ensure the next generation of medical breakthroughs is developed right here&amp;hellip;.&lt;/em&gt;&lt;/a&gt;, X (June 22, 2026).]] FDA believes that targeting the earliest development stage (i.e., Phase 1) alone could shave 6 to 12 months off a drug program&amp;rsquo;s overall development timeline.[[N:&lt;em&gt;HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials&lt;/em&gt;; Robert F. Kennedy, Jr., &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.foxnews.com/opinion/robert-f-kennedy-jr-future-medicine-built-america" target="_blank"&gt;The Future of Medicine Will Be Built in America&lt;/a&gt;&lt;/em&gt;, Fox News (June 22, 2026).]]&lt;/p&gt;
&lt;p&gt;FDA&amp;rsquo;s proposed Expedited-IND Pilot program is aimed at reversing a trend of clinical research and development moving abroad, namely to China. China surpassed the U.S. for the global share of phase 1 clinical trials in 2021 and has continued to extend its lead in the number of early-stage trials globally.[[N:&lt;em&gt;Operation TrialBlazer&lt;/em&gt;, at 4; Kennedy, &lt;em&gt;supra&lt;/em&gt; note 3; &lt;em&gt;see also &lt;/em&gt;Jim Cornall, &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://www.labiotech.eu/trends-news/report-china-leads-phase-1-clinical-trials/" target="_blank"&gt;Report: China Leads the Way With Phase 1 Studies, Labiotech&lt;/a&gt;&lt;/em&gt; (Feb. 17, 2023).]] Operation TrialBlazer recognizes that China is gaining this competitive advantage since streamlining its regulatory pathways and strengthening its clinical trial infrastructure, which attract sponsors and investment for conducting clinical trial research.[[N:&lt;em&gt;Operation TrialBlazer&lt;/em&gt;, at 4.]]&lt;/p&gt;
&lt;p&gt;Various ideas have spread throughout the government and industry on how to reverse the trend.[[N:&lt;em&gt;See&lt;/em&gt;, &lt;em&gt;e.g.&lt;/em&gt;, &lt;a rel="noopener noreferrer" href="https://reaganudall.org/sites/default/files/2026-06/Enhancing Early-Stage Drug Development in the US_1.pdf" target="_blank"&gt;Reagan-Udall Found., Enhancing Early-Stage Drug Development in the United States&lt;/a&gt; (June 2026) (providing recommendations and solutions to modernize the early-stage clinical trial ecosystem in the U.S.).]] U.S. congressmembers have called for legislation that, if enacted, would prohibit FDA from accepting, reviewing, or considering certain clinical data generated in China in support of an IND, noting concerns with patient safety standards, human rights, and independence from government influence.[[N:&lt;a rel="noopener noreferrer" href="https://docs.house.gov/meetings/AP/AP00/20260429/119253/HMKP-119-AP00-20260429-SD003.pdf" target="_blank"&gt;Manager&amp;rsquo;s Amendment, H.R. Comm. on Appropriations, Subcomm. on Agric., Rural Dev., Food &amp;amp; Drug Admin., &amp;amp; Related Agencies, FY 2027 Agriculture Appropriations Bill Markup 7&lt;/a&gt; (Apr. 29, 2026).]] FDA has asked Congress to create an expedited IND pathway in its fiscal year 2027 budget request.[[N:U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="https://www.fda.gov/media/191778/download" target="_blank"&gt;Fiscal Year 2027 Justification of Estimates for Appropriations Committees 26-27&lt;/a&gt; (2026).]] There have been calls for additional reforms to Institutional Review Boards (IRBs),[[N:Zachary Brennan, &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://endpoints.news/makary-pushes-for-irb-reforms-to-catch-chinas-speedy-trial-starts/" target="_blank"&gt;Makary Pushes for IRB Reforms to Catch China&amp;rsquo;s Speedy Trial Starts&lt;/a&gt;&lt;/em&gt;, Endpoints News (Mar. 16, 2026); &lt;em&gt;see also Operation TrialBlazer&lt;/em&gt;, at 11-12.]] to the way that FDA conducts clinical trial inspections in China,[[N:&lt;em&gt;See&lt;/em&gt; Jessica Karins, &lt;em&gt;&lt;a rel="noopener noreferrer" href="https://insidehealthpolicy.com/daily-news/lawmakers-call-more-fda-scrutiny-chinese-clinical-trial-sites" target="_blank"&gt;Lawmakers Call For More FDA Scrutiny Of Chinese Clinical Trial Sites&lt;/a&gt;&lt;/em&gt;, InsideHealthPolicy (Aug. 21, 2024).]] and to strengthen human subject protections for clinical trials conducted in China.[[N:&lt;a rel="noopener noreferrer" href="https://www.rickscott.senate.gov/services/files/F16597A1-7153-4615-AA22-19CAAFBBED71" target="_blank"&gt;Letter from Sen. Rick Scott, U.S. Senator, to Robert F. Kennedy, Jr., Sec&amp;rsquo;y of Health &amp;amp; Hum. Servs., Martin Makary, Comm&amp;rsquo;r of U.S. Food &amp;amp; Drug Admin., &amp;amp; Jay Bhattacharya, Dir., Nat&amp;rsquo;l Insts. of Health&lt;/a&gt; (Mar. 19, 2026).]] Prescription Drug User Fee Act (PDUFA) VIII has included discussions of user fee incentives for domestic drug development&amp;mdash;as well as potentially higher fees for applications that do not include domestic clinical trial data.[[N:&lt;em&gt;See&lt;/em&gt; U.S. Food &amp;amp; Drug Admin. &amp;amp; Industry Steering Comm., Prescription Drug User Fee Act (PDUFA) Reauthorization Meeting (meeting notes from March 10, 12, and 19, 2026) (collectively describing FDA&amp;rsquo;s proposal).]] FDA&amp;rsquo;s new Expedited-IND Pilot program proposes to pull more trials to the U.S. by expediting IND clearance for FIH clinical trials.&lt;/p&gt;
&lt;h2&gt;A Proposed Path to Expedite the First-in-Human Milestone&lt;/h2&gt;
&lt;p&gt;On June 24, 2026, FDA opened a request for information (RFI) to solicit stakeholder input on the proposed Expedited-IND Pilot program.[[N:Expedited Investigational New Drug Pilot Program; Request for Information, 91 Fed. Reg. 37996, 37996 (June 24, 2026).]] The Expedited-IND Pilot program would establish a network of &amp;ldquo;Qualified Research Institutions&amp;rdquo; (QRIs) that would assess information required to be included in an initial IND submission (i.e., pharmacology and toxicology, clinical, and CMC information)[[N:&lt;em&gt;See &lt;/em&gt;21 C.F.R. &amp;sect; 312.23.]] and make recommendations&amp;mdash;potentially as part of a rolling review of IND materials. &lt;/p&gt;
&lt;p&gt;While there will undoubtedly be legal questions as to the basis for FDA&amp;rsquo;s reliance on QRIs, FDA is clear that it would retain full regulatory oversight of the IND submission, including the authority to impose a clinical hold, disqualify an investigator or IRB, conduct clinical trial inspections, and enforce safety reporting requirements.[[N:91 Fed. Reg. at 37998.]] QRIs would only act as a &amp;ldquo;review and advisory resource&amp;rdquo; to sponsors (sponsors would remain responsible for their IND submissions).[[N: &lt;em&gt;Id.; Operation TrialBlazer&lt;/em&gt;, at 11.]] But QRIs would be expected to expedite overall review timelines by improving the quality of IND submissions, reducing the likelihood that FDA imposes a clinical hold, reducing the time for FDA to review INDs, bridging between IRBs and FDA, and potentially making recommendations to FDA that would reduce the regulatory burden associated with IND review.[[N:91 Fed. Reg. at 37998.]] The RFI seeks input regarding the types of tasks QRIs could take on and how these processes might be structured. &lt;/p&gt;
&lt;p&gt;As currently proposed in the RFI, QRIs would be responsible for:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt; advising and providing written recommendations to sponsors on the nonclinical (pharmacology and toxicology), clinical, and CMC components of sponsors&amp;rsquo; IND submissions;&lt;/li&gt;
    &lt;li&gt;conducting conflict of interest screening and establishing a formal engagement agreement with the sponsor;&lt;/li&gt;
    &lt;li&gt;holding regular meetings with the sponsor and appropriate subject matter experts to discuss IND development progress;&lt;/li&gt;
    &lt;li&gt;maintaining records of discussions, recommendations, and interactions with sponsors;&lt;/li&gt;
    &lt;li&gt;sharing their recommendations with FDA through the rolling submission platform (discussed below); and&lt;/li&gt;
    &lt;li&gt;participating in pilot evaluation activities and supporting parallel activities, such as IRB review and clinical trial site activation.[[N:&lt;em&gt;Id.&lt;/em&gt;]]&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;To be qualified, a potential QRI would need to demonstrate capabilities, infrastructure, and leadership expertise across nonclinical, clinical, and CMC disciplines, regulatory affairs, and clinical trials relevant to FIH IND submissions and Phase 1 studies.[[N:&lt;em&gt;Id.&lt;/em&gt; at 37998-99.]] FDA indicates that QRIs may need to obtain a formal certification from the Agency after the pilot concludes.[[N:&lt;em&gt;Id.&lt;/em&gt; at 37998.]]&lt;/p&gt;
&lt;p&gt;As part of the RFI, FDA also seeks input regarding a proposed rolling submission platform through which FDA could review QRI recommendations to the completed components of a sponsor&amp;rsquo;s IND submission before the final IND submission.[[N:&lt;em&gt;Id.&lt;/em&gt;]] FDA likens the rolling review process to the rolling review of a New Drug Application or Biologics License Application under existing expedited review programs.[[N:&lt;em&gt;Id.&lt;/em&gt;]] FDA believes that rolling review would afford the Agency an earlier opportunity to resolve potential deficiencies that would result in a clinical hold or information request, and to sooner issue the sponsor a &amp;ldquo;safe to proceed&amp;rdquo; letter authorizing the FIH study to commence.[[N:&lt;em&gt;Id.&lt;/em&gt;]] Barring a &amp;ldquo;safe to proceed letter&amp;rdquo; or clinical hold, a sponsor must wait 30 days from the date that FDA receives an IND to begin a clinical study.[[N:21 C.F.R. &amp;sect; 312.40(b). ]]&lt;/p&gt;
&lt;p&gt;FDA believes that accelerating the time to reach FIH milestones would also help biopharmaceutical companies secure key partnerships, attract greater investment in biomedical research in the U.S., and bring new therapies and cures to Americans more quickly.[[N:91 Fed. Reg. at 37997.]]&lt;/p&gt;
&lt;h2&gt;The RFI Provides Opportunities to Shape the Expedited-IND Pilot Program&lt;/h2&gt;
&lt;p&gt;FDA seeks extensive stakeholder input on the contours of the Expedited-IND Pilot program and the qualifications and responsibilities of QRIs.[[N:&lt;em&gt;See id.&lt;/em&gt; at 37999.]] We suggest that stakeholders consider engaging in the RFI process to offer feedback on the details of the pilot program&amp;mdash;some potential areas are highlighted below&amp;mdash;before FDA readies the program for a premiere. If finalized, the program&amp;rsquo;s frameworks may necessitate a shift in thinking in conventional clinical research agreements, including sponsor relationships with IRBs, academic medical centers, and central labs, and require new approaches to delegation of authority documents and clinical research organization arrangements. For example, if adopted, the proposals could lead to a race for centers to become qualified QRIs and for sponsors and other parties to contract with those centers first, raising important questions about capacity, quality, and liability.&lt;/p&gt;
&lt;p&gt;Interested parties can submit comments on the proposed Expedited-IND Pilot program through July 22, 2026,[[N:&lt;em&gt;Id. &lt;/em&gt;at 37997.]] including comments regarding: &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;em&gt;Scope and scale&lt;/em&gt; &amp;ndash; e.g., how many QRIs and therapeutic areas/modalities should be included in the pilot program? How long should the pilot program last, or what volume of participation is appropriate before the pilot program is evaluated?&lt;/li&gt;
    &lt;li&gt;&lt;em&gt;QRI qualifications and capabilities&lt;/em&gt; &amp;ndash; e.g., what changes, if any, should be made to the recommended capabilities, infrastructure, and/or leadership expertise for QRIs? Should QRIs be required to have a self-owned and operated IRB and/or clinical trial site? If a QRI also serves as an IRB for a sponsor, how can potential conflicts of interest be prevented?&lt;/li&gt;
    &lt;li&gt; &lt;em&gt;Drug eligibility &lt;/em&gt;&amp;ndash; e.g., which types of products and/or specific diseases or conditions should be considered for the pilot program? How should they be prioritized for participation? &lt;/li&gt;
    &lt;li&gt;&lt;em&gt;Pre-IND and IND review process&lt;/em&gt; &amp;ndash; e.g., what should be the output of QRI advice and review? What information from this review should be submitted to FDA?&lt;/li&gt;
    &lt;li&gt; &lt;em&gt;Oversight and accountability&lt;/em&gt; &amp;ndash; e.g., how should FDA resolve situations in which it disagrees with QRI recommendations? &lt;/li&gt;
    &lt;li&gt; &lt;em&gt;Risks to patients&lt;/em&gt; &amp;ndash; e.g., does the pilot program inadvertently compromise the safety of trial participants, the scientific rigor of the trial, or ethical standards of the trial? How can FDA mitigate these risks?&lt;/li&gt;
&lt;/ul&gt;
&lt;p style="text-align: center;"&gt;***&lt;/p&gt;
&lt;p&gt;If you have any questions, would like more information, or would like to discuss submitting a comment to FDA&amp;rsquo;s RFI (by July 22, 2026), FDA&amp;rsquo;s 2026 Draft Substantial Evidence Guidance (by September 22, 2026), or the Office of Inspector General&amp;rsquo;s RFI (by August 24, 2026), please reach out to one of the authors of this Advisory or your existing Arnold &amp;amp; Porter contacts.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{59A720FC-F3A3-49E4-8195-D1839D1105D1}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/06/the-chemical-compound</link><a10:author><a10:name>Camille Heyboer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/heyboer-camille</a10:uri><a10:email>camille.heyboer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katrina R. Umstead</a10:name><a10:uri>https://www.arnoldporter.com/en/people/u/umstead-katrina</a10:uri><a10:email>katrina.umstead@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lawrence E. Culleen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/culleen-lawrence-e</a10:uri><a10:email>lawrence.culleen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brandon W. Neuschafer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/neuschafer-brandon-w</a10:uri><a10:email>brandon.neuschafer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tom Fox</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fox-tom</a10:uri><a10:email>Tom.Fox@arnoldporter.com</a10:email></a10:author><title>The Chemical Compound – Q2 2026</title><description>This edition of our quarterly newsletter on chemical regulatory developments provides updates on litigation, regulatory, legislative, and policy developments of importance to our clients. The newsletter focuses on actions affecting chemical substances that are the subject of ongoing regulatory activity or scrutiny by federal, state, and international authorities, as well as developments in related litigation.</description><pubDate>Wed, 24 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This edition of our quarterly newsletter on chemical regulatory developments provides updates on litigation, regulatory, legislative, and policy developments of importance to our clients. The newsletter focuses on actions affecting chemical substances that are the subject of ongoing regulatory activity or scrutiny by federal, state, and international authorities, as well as developments in related litigation. These include, among others, per- and polyfluoroalkyl substances (PFAS) and other chemicals of concern to the U.S. Environmental Protection Agency (EPA or the Agency) under the Toxic Substances Control Act (TSCA), EPA pesticide actions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as emerging regulatory frameworks in the United States and abroad. Check here each quarter for a curated presentation of the most important developments affecting chemical manufacturers, importers, processors, and users. &lt;/p&gt;
&lt;h2&gt;Table of Contents&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;span style="font-size: 24px;"&gt;&lt;a href="#TSCA Updates"&gt;TSCA Updates&lt;/a&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;span style="font-size: 24px;"&gt;&lt;a href="#FIFRA Updates"&gt;FIFRA Updates&lt;/a&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;span style="font-size: 24px;"&gt;&lt;a href="#Federal Litigation Updates"&gt;Federal Litigation Updates&lt;/a&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;span style="font-size: 24px;"&gt;&lt;a href="#State Regulatory Updates"&gt;State Regulatory Updates&lt;/a&gt;&lt;/span&gt;&lt;/li&gt;
    &lt;li&gt;&lt;span style="font-size: 24px;"&gt;&lt;a href="#European Union"&gt;European Union&lt;/a&gt;&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;
&lt;/p&gt;
&lt;h2&gt;&lt;a name="TSCA Updates"&gt;&lt;/a&gt;TSCA Updates&lt;/h2&gt;
&lt;h3&gt;EPA Releases Initial Lists of Expiring TSCA CBI Claims&lt;/h3&gt;
&lt;p&gt;EPA recently released its &lt;a rel="noopener noreferrer" href="https://www.epa.gov/tsca-cbi/cbi-claim-expiration" target="_blank"&gt;initial lists&lt;/a&gt; of TSCA confidential business information (CBI) claims scheduled to expire beginning June 22, marking the beginning of a new phase in the Agency&amp;rsquo;s implementation of TSCA&amp;rsquo;s 10-year limit on most confidentiality claims. EPA has explained that confidentiality claims for most information submitted under TSCA expire 10 years after the date on which the claim was asserted, while claims for specific chemical identity generally expire 10 years from the submission date of the first approved post-June 22, 2016, claim for that identity. Importantly, this means that some submitters may find that the chemical identity CBI claim applicable to their submission expires less than 10 years after their own filing. &lt;/p&gt;
&lt;p&gt;EPA&amp;rsquo;s initial list covered claims expiring between June 22, 2026, and July 31, 2026, and the Agency subsequently released a list of claims expiring in August 2026. The Agency is expected to update the lists monthly as additional claims approach expiration. Submitters that wish to extend a claim must request an extension through EPA&amp;rsquo;s Central Data Exchange (CDX) and provide the required substantiation at least 30 days before the claim&amp;rsquo;s expiration date. EPA also hosted a May 6 &lt;a rel="noopener noreferrer" href="https://www.epa.gov/system/files/documents/2026-05/tsca-cbi-claims-expiration-webinar.pdf" target="_blank"&gt;webinar&lt;/a&gt; addressing the lifecycle of TSCA CBI claims, how to determine whether a claim is expiring, and how to request an extension, including a demonstration of the CDX application. &lt;/p&gt;
&lt;p&gt;Companies with prior TSCA submissions should review EPA&amp;rsquo;s lists and evaluate whether any expiring claims cover information that remains confidential and commercially sensitive. Where continued protection is warranted, companies should ensure that their CDX access is current and that substantiation materials are prepared in advance of the applicable deadline. Notably, EPA stressed during the May 6 webinar the importance of robust substantiation for CBI claims, and emphasized that substantiation deemed acceptable at the time of the original claims may not be sufficient to support an extension request. Absent a timely extension request, EPA has stated that it is not required to continue protecting the information from disclosure.&amp;nbsp;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;EPA Enforcement Action Highlights TSCA Import Compliance Risk&lt;/h3&gt;
&lt;p&gt;On June 1, EPA &lt;a rel="noopener noreferrer" href="https://www.epa.gov/newsreleases/epa-files-case-against-chemical-supplier-failing-disclose-imports-hundreds-millions" target="_blank"&gt;announced&lt;/a&gt; an administrative complaint against Wego Chemical Group and affiliated companies for violations of TSCA arising from the importation and domestic distribution of chemical substances. The complaint alleges eight categories of violations reflecting what EPA describes as a sustained pattern of failing to report, notify, and certify, including failure to submit timely Chemical Data Reporting (CDR) data and required use information across two reporting cycles, failure to submit a premanufacture notice (PMN) and significant new use notices, and the filing of inaccurate regulatory submissions. EPA also alleged that Wego submitted a false certification that it had not imported a chemical subject to a TSCA risk evaluation during the preceding five years.&lt;/p&gt;
&lt;p&gt;The complaint follows TSCA Section 20 citizen suits premised on alleged CDR reporting violations, including a 2025 settlement reached between Wego and an environmental organization, illustrating the potential for citizen enforcement activity to precede or inform subsequent EPA action. The action also reflects EPA&amp;rsquo;s broader emphasis on import enforcement, including the Agency&amp;rsquo;s &lt;a rel="noopener noreferrer" href="https://www.epa.gov/newsreleases/epa-accelerates-crackdown-toxic-and-poisonous-imports-concert-cbp-keeping-americans" target="_blank"&gt;coordinated effort &lt;/a&gt;with U.S. Customs and Border Protection to increase scrutiny of chemicals, pesticides, and other products entering the United States. For companies that import chemical substances or products containing regulated chemicals, the complaint is a reminder that TSCA obligations may attach at several stages of the import process and that deficiencies in reporting, notification, or certification can create exposure to both citizen suits and EPA enforcement.&lt;/p&gt;
&lt;h3&gt;EPA Issues Final Risk Evaluation for 1,2-Dichloroethane, Starting TSCA Risk Management Clock&lt;/h3&gt;
&lt;p&gt;On May 5, EPA &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/05/05/2026-08682/12-dichloroethane-final-risk-evaluation-under-the-toxic-substances-control-act-tsca-notice-of" target="_blank"&gt;announced&lt;/a&gt; its final TSCA risk evaluation for 1,2-dichloroethane, also known as ethylene dichloride or EDC. 1,2-dichloroethane is primarily used in the synthesis of vinyl chloride and also has industrial uses as a solvent and in the manufacture of other chemicals.&lt;/p&gt;
&lt;p&gt;EPA determined that 1,2-dichloroethane presents an unreasonable risk of injury to human health under 15 conditions of use, with the identified risks driven by workplace exposures to workers and occupational non-users. EPA did not identify unreasonable risk to consumers, the general population, or the environment. Consistent with TSCA&amp;rsquo;s risk evaluation framework, EPA made its unreasonable risk determination without consideration of costs or other non-risk factors.&lt;/p&gt;
&lt;p&gt;EPA&amp;rsquo;s next step is to develop a TSCA Section 6(a) risk management rule to address the unreasonable risk identified in the final risk evaluation. Under TSCA Section 6(c), EPA generally must publish a proposed risk management rule within one year of issuing a final risk evaluation that finds unreasonable risk, and a final rule within two years. Accordingly, EPA&amp;rsquo;s deadline for the proposed rule for 1,2-dichloroethane is May 5, 2027, absent an applicable extension. The risk management process will provide the key forum for affected manufacturers, processors, and users to engage with EPA on potential restrictions, compliance timelines, workplace controls, and other measures to address the identified occupational risks.&lt;/p&gt;
&lt;h3&gt;EPA Releases 2024 Chemical Data Reporting Information&lt;/h3&gt;
&lt;p&gt;On April 16, EPA &lt;a rel="noopener noreferrer" href="https://www.epa.gov/chemicals-under-tsca/epa-empowers-americans-2024-chemical-data-reporting-information" target="_blank"&gt;released&lt;/a&gt; information submitted during the 2024 Chemical Data Reporting (CDR) cycle, providing public access to data on chemicals manufactured in or imported into the United States between 2020 and 2023. CDR is EPA&amp;rsquo;s primary TSCA Section 8(a) reporting program for collecting basic exposure-related information, including chemical identity, production volumes, manufacturing and import activity, processing and use information, and certain industrial, commercial, and consumer use data.&lt;/p&gt;
&lt;p&gt;The 2024 CDR data reflect submissions from manufacturers, including importers, of TSCA Inventory chemicals that met applicable reporting thresholds &amp;mdash; generally 25,000 pounds or more at a single site, or 2,500 pounds or more for certain chemicals subject to specified TSCA actions. EPA stated that the data are available in downloadable files and will be added to ChemView. The Agency also emphasized that it uses CDR data to support chemical prioritization, risk evaluation, and other TSCA activities.&lt;/p&gt;
&lt;p&gt;The release provides companies with an opportunity to review publicly available information about their own submissions, as well as submissions relating to their suppliers, customers, competitors, and substances of regulatory interest. Companies may also wish to consider whether the public data align with their understanding of chemical uses and supply chains, particularly for chemicals that could be candidates for future prioritization or risk evaluation. The next CDR reporting cycle is scheduled for 2028. The submission period is expected to run from June 1, 2028, through September 30, 2028 and will require reporting of data from 2024-2027.&lt;/p&gt;
&lt;h3&gt;EPA Extends Start of TSCA PFAS Reporting Period&amp;nbsp;&lt;/h3&gt;
&lt;p&gt;On April 13, EPA &lt;a rel="noopener noreferrer" href="https://www.govinfo.gov/content/pkg/FR-2026-04-13/pdf/2026-07062.pdf" target="_blank"&gt;released&lt;/a&gt; a final rule extending the start of the reporting period for the TSCA Section 8(a)(7) PFAS reporting rule. The reporting period had been scheduled to begin on April 13, 2026, but will now begin on January 31, 2027, or 60 days after the effective date of EPA&amp;rsquo;s forthcoming final rule addressing the substantive PFAS reporting requirements, whichever is earlier.&lt;/p&gt;
&lt;p&gt;EPA effectuated this extension by finalizing only the timing amendment from its November 2025 proposed rule, which also proposed broader changes to the PFAS reporting regulation. Those proposed changes included potential exemptions or limitations for certain imported articles, de minimis levels, impurities, byproducts, research and development substances, and non-isolated intermediates. EPA stated that it expects to finalize the substantive revisions &amp;ldquo;well before&amp;rdquo; the January 31, 2027, backstop date for the opening of the submission period and may further address the duration of the submission period as part of that forthcoming final rule.&lt;/p&gt;
&lt;p&gt;For now, EPA has retained the current six-month submission period, with an additional six months for small manufacturers whose reporting obligations arise exclusively from importing PFAS-containing articles. The extension gives EPA additional time to consider comments on the November 2025 proposal and gives potentially regulated entities more time to evaluate their reporting obligations under the existing rule, and how their reporting obligations may change under the November 2025 proposal. Companies that manufactured or imported PFAS, including PFAS-containing articles, during the 2011-2022 reporting period should continue monitoring EPA&amp;rsquo;s forthcoming substantive rulemaking and use the additional time to assess supply chain information, historical import records, and potential applicability of any final exemptions.&lt;/p&gt;
&lt;h3&gt;EPA Releases Draft Risk Evaluations for HHCB and Phthalic Anhydride&lt;/h3&gt;
&lt;p&gt;On April 10, EPA published draft risk evaluations for &lt;a rel="noopener noreferrer" href="https://www.epa.gov/system/files/documents/2026-04/01-hhcb-draft-risk-evaluation-public-release-march-2026.pdf" target="_blank"&gt;1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-Benzopyran (HHCB)&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.epa.gov/system/files/documents/2026-04/01-draft-risk-evaluation-for-phthalic-anhydride-public-release-march-2026.pdf" target="_blank"&gt;phthalic anhydride&lt;/a&gt;. EPA also published a Federal Register notice opening a 60-day public comment period on the two draft risk evaluations, which closed on June 15, 2026. A separate Federal Register notice sought comment by May 29, 2026, on materials to be considered by EPA&amp;rsquo;s Science Advisory Committee on Chemicals (SACC), which met June 8-12, 2026, to peer review the draft evaluations and related materials.&lt;/p&gt;
&lt;p&gt;EPA&amp;rsquo;s draft HHCB risk evaluation preliminarily concludes that HHCB does not present an unreasonable risk under the conditions of use evaluated. HHCB is used as a fragrance ingredient or odor agent in chemical product and plastics manufacturing and in products such as detergents, cleaners, air fresheners, and plastic and rubber articles. If finalized as drafted, the HHCB evaluation would represent a notable instance in which EPA concludes that a high-priority substance does not present unreasonable risk under TSCA Section 6 and for which EPA would therefore not be required to pursue risk management.&lt;/p&gt;
&lt;p&gt;By contrast, EPA&amp;rsquo;s draft phthalic anhydride risk evaluation preliminarily concludes that the chemical presents an unreasonable risk to workers and consumers from dermal and inhalation exposures. The worker-related conditions of use identified as contributing to unreasonable risk include industrial and commercial uses in transportation equipment manufacturing, machinery and mechanical applications, and electrical and electronic articles. EPA also identified consumer uses in adhesives and sealants and in paints and coatings as contributing to unreasonable risk. If EPA finalizes this unreasonable risk determination, it will then be required to propose risk management measures to address the identified unreasonable risk.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;EPA Releases Draft Hazard Assessments for o-DCB and p-DCB&lt;/h3&gt;
&lt;p&gt;On April 10, EPA published draft hazard assessments for &lt;a rel="noopener noreferrer" href="https://www.epa.gov/system/files/documents/2026-04/2-o-dichlorobenzene-draft-human-and-environmental-hazard-assessment-public-release-april-2026.pdf" target="_blank"&gt;o-dichlorobenzene (o-DCB)&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.epa.gov/system/files/documents/2026-04/4-p-dichlorobenzene-draft-human-health-and-env-haz-assess-public-release-apr-2026.pdf" target="_blank"&gt;p-dichlorobenzene (p-DCB)&lt;/a&gt;, which will support EPA&amp;rsquo;s forthcoming TSCA draft risk evaluations for those chemicals. EPA has not yet issued unreasonable risk determinations for o-DCB or p-DCB. Instead, the Agency is first seeking public comment and SACC peer review on the draft hazard assessments and related technical support documents before releasing the draft risk evaluations.&lt;/p&gt;
&lt;p&gt;o-DCB is used in the manufacture of chemicals, plastic materials, and resins, and in products such as inks, colorants, and lubricants, including degreasers. p-DCB is used as a reactant in plastic material and resin manufacturing, in pesticide and fertilizer manufacturing processes, and in products such as plastic foam sealants and insulation and automotive care products. EPA&amp;rsquo;s draft hazard assessments are noteworthy because the Agency used New Approach Methods (NAMs), including transcriptomics, in developing the assessments and has described the scientific approaches as &amp;ldquo;unique and novel.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The SACC peer review meeting took place on June 8-12, 2026. The Agency&amp;rsquo;s use of NAMs in these assessments was an important topic of this meeting and will likely be an important focus of the peer review. The SACC report on these draft hazard assessments may therefore provide insight into how EPA intends to incorporate transcriptomic and other nontraditional data streams into future TSCA risk evaluations.&lt;/p&gt;
&lt;h3&gt;EPA Publishes Draft Risk Evaluation for TBBPA&lt;/h3&gt;
&lt;p&gt;On June 16, EPA published a &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/06/16/2026-12012/44-1-methylethylidenebis26-dibromophenol-tbbpa-risk-evaluation-under-the-toxic-substances-control" target="_blank"&gt;notice &lt;/a&gt;in the Federal Register announcing the availability of the draft risk evaluation for 4,4&amp;rsquo;-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA). TBBPA is primarily used as a reactant for flame retardants or as an additive flame retardant. It is found in electrical and electronic products, plastic and rubber products, and textiles in cars and airplanes, among other uses. In the draft risk evaluation, EPA identified unreasonable risk to workers driven by three conditions of use: manufacture, import, and repackaging. EPA also identified unreasonable risk to the environment driven by the incorporation of TBBPA into a formulation for use as a flame retardant in the manufacturing of plastics, resin, and paints and coatings. Notably EPA identified risk threshold exceedances for a number of other conditions of use but has preliminarily determined that these conditions of use do not contribute to the unreasonable risk because, for example, the Agency does not expect that the conditions under which the risk threshold exceedances exist are expected to occur in the real world. EPA has opened a public comment period through August 17, 2026, on the draft TBBPA risk evaluation.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;EPA Again Extends TSCA Section 8(d) Reporting Deadline to May 2027&lt;/h3&gt;
&lt;p&gt;On May 22, EPA &lt;a rel="noopener noreferrer" href="https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10263.pdf" target="_blank"&gt;finalized&lt;/a&gt; a one-year extension of the reporting deadline for its TSCA Section 8(d) Health and Safety Data Reporting Rule. The rule, originally issued in December 2024, requires manufacturers, including importers, of 16 listed chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. The reporting deadline had previously been May 22, 2026, and has now been extended to May 21, 2027.&lt;/p&gt;
&lt;p&gt;EPA explained that it is considering potential modifications to the scope of the Section 8(d) rule and the prior deadline would not provide sufficient time for EPA to complete its reconsideration. EPA previously proposed the extension on March 30, 2026, and finalized it without changing the substance of the underlying reporting obligations. The final rule became effective upon its publication on May 22, 2026.&lt;/p&gt;
&lt;p&gt;The extension provides additional time for potentially covered manufacturers and importers to evaluate whether they may have reporting obligations and to identify responsive unpublished health and safety studies. At the same time, because EPA may further modify the rule, companies should continue to monitor the reconsideration process.&amp;nbsp;&lt;/p&gt;
&lt;h2&gt;&lt;a name="FIFRA Updates"&gt;&lt;/a&gt;FIFRA Updates&lt;/h2&gt;
&lt;h3&gt;EPA Publishes Draft Fungicide Endangered Species Strategy&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;On April 30, EPA published for public comment its &amp;ldquo;&lt;a rel="noopener noreferrer" href="https://www.regulations.gov/document/EPA-HQ-OPP-2026-2973-0002" target="_blank"&gt;Draft Fungicide Strategy to Reduce Exposure of Federally Listed Endangered and Threatened Species and Designated Critical Habitats from the Use of Conventional Agricultural Fungicides&lt;/a&gt;&amp;rdquo; (the &amp;ldquo;Fungicide Strategy&amp;rdquo;). This document is intended to outline EPA&amp;rsquo;s approach to &amp;ldquo;assess[ing] possible population-level impacts to listed species and identify[ing] mitigation to reduce the potential impacts from the use of agricultural fungicides,&amp;rdquo; in order to accelerate EPA&amp;rsquo;s ability to meet its obligations under the Endangered Species Act for the registration of agricultural fungicides.&amp;nbsp; Under the draft Fungicide Strategy, EPA will first determine the potential for population-level impacts to endangered and threatened species from both on-field and off-field exposures, assess the appropriate level of mitigation based on the potential for population-level impacts, and identify the geographical area in which such mitigations are expected to be necessary. This strategy follows similar EPA strategies for &lt;a rel="noopener noreferrer" href="https://www.epa.gov/endangered-species/strategy-protect-endangered-species-insecticides" target="_blank"&gt;insecticides&lt;/a&gt;, &lt;a rel="noopener noreferrer" href="https://www.epa.gov/endangered-species/strategy-protect-endangered-species-herbicides" target="_blank"&gt;herbicides&lt;/a&gt;, and &lt;a rel="noopener noreferrer" href="https://www.epa.gov/endangered-species/strategy-protect-endangered-species-rodenticides" target="_blank"&gt;rodenticides&lt;/a&gt;. EPA is accepting public comment on the draft Fungicide Strategy until June 29, 2026, and intends to finalize the Fungicide Strategy by the end of November 2026.&lt;/p&gt;
&lt;h2&gt;&lt;a name="Federal Litigation Updates"&gt;&lt;/a&gt;Federal Litigation Updates&lt;/h2&gt;
&lt;h3&gt;&lt;span&gt; &lt;/span&gt;Ninth Circuit Remands EPA&amp;rsquo;s DecaBDE Rule Without Vacatur&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;On May 13, the Ninth Circuit remanded to EPA the latest version of the Agency&amp;rsquo;s first TSCA Section 6 rule issued following the 2016 amendments to the Act.&amp;nbsp; Specifically, the court granted consolidated petitions filed by Alaska Community Action on Toxics, the Yurok Tribe, Consumer Federation of America, and Center for Environmental Transformation challenging EPA&amp;rsquo;s 2024 TSCA section 6(h) rule for decabromodiphenyl ether (decaBDE), a persistent, bioaccumulative, and toxic (PBT) chemical used as an additive flame retardant in products such as electronics, appliances, and vehicle and aircraft components.&lt;/p&gt;
&lt;p&gt;The court held that EPA had not supported with substantial evidence its decisions not to further regulate four pathways for potential decaBDE exposures: recycling of articles, disposal, wastewater, and sewage sludge. In the court&amp;rsquo;s view, TSCA Section 6(h) requires EPA to reduce exposure to PBT chemicals &amp;ldquo;to the extent practicable,&amp;rdquo; and EPA could not decline to impose restrictions based on &amp;ldquo;low levels&amp;rdquo; of exposure to decaBDE, a general policy to encourage recycling, or the existence of other statutory regimes such as RCRA, without adequately addressing contrary record evidence and available regulatory alternatives. The court reasoned that, because Congress had already identified decaBDE as sufficiently hazardous to warrant expedited regulation under Section 6(h), exposure levels may inform EPA&amp;rsquo;s choice of regulatory tools but cannot, standing alone, justify a decision not to regulate. The panel also rejected EPA&amp;rsquo;s argument that it could defer additional regulation of these pathways, finding that Section 6(h) calls for expedited action rather than open-ended, tiered rulemaking.&lt;/p&gt;
&lt;p&gt;The court remanded the rule to EPA without vacatur, thus leaving the 2024 rule in effect while EPA considers how to respond to the recent ruling As a result, current requirements&amp;mdash;including worker protection requirements and restrictions on releases to water during the manufacture, processing, and distribution in commerce of decaBDE and decaBDE-containing products&amp;mdash;remain operative pending further action from EPA. The opinion underscores the Ninth Circuit&amp;rsquo;s view that, for PBT chemicals regulated under TSCA Section 6(h), EPA must meaningfully evaluate practicable exposure-reduction measures across the chemical&amp;rsquo;s lifecycle and support any decision not to regulate with substantial record evidence. Of note, the court&amp;rsquo;s decision addresses only the decaBDE rule and does not directly affect EPA&amp;rsquo;s other Section 6(h) rules issued for PBT chemicals, specifically: phenol, isopropylated phosphate (PIP (3:1)), 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HBCD), and pentachlorothiophenol (PCTP).&lt;/p&gt;
&lt;h3&gt;Ninth Circuit Vacates District Court Decision Requiring EPA To Act on TSCA Section 21 Petition for Regulation of Fluoride in Drinking Water&amp;nbsp;&lt;/h3&gt;
&lt;p&gt;On May 21, the Ninth Circuit vacated and remanded the Northern District of California&amp;rsquo;s decision directing EPA to regulate fluoridation of drinking water under TSCA Section 6(a). The case arose from EPA&amp;rsquo;s denial of a 2016 TSCA Section 21 petition seeking a rule banning the addition of fluoride to drinking water. After two bench trials, the district court held that fluoridation of drinking water at 0.7 mg/L presents an unreasonable risk to human health and ordered EPA to address that risk under TSCA.&lt;/p&gt;
&lt;p&gt;In its decision, the Ninth Circuit did not address whether fluoridation at 0.7 mg/L (or any other level) presents an unreasonable risk. Instead, the court held that the district court &amp;ldquo;commandeer[ed]&amp;rdquo; the case by refusing to decide the matter on the first trial record despite both parties urging it to do so, holding the case in abeyance while awaiting additional scientific materials, and then relying on evidence the parties had agreed not to present. The panel concluded that this &amp;ldquo;takeover&amp;rdquo; of the evidentiary presentation by the district court violated the party-presentation principle and therefore remanded the case for the district court to rule based solely on the first trial record.&lt;/p&gt;
&lt;p&gt;The decision is narrow but important for TSCA Section 21 practice. The Ninth Circuit further held that, under the circumstances of the first bench trial, the district court did not err in considering evidence beyond the materials submitted with the original petition, but the panel explicitly declined to address whether Section 21 would permit such supplementation in other circumstances. The court also remanded EPA&amp;rsquo;s standing arguments for consideration by the district court in the first instance. The remand leaves unresolved several issues with potentially broader implications for citizen petitions, including the permissible scope of judicial review and the role Section 21 litigation may play in prompting EPA action under TSCA.&lt;/p&gt;
&lt;h3&gt;Fifth Circuit Hears Argument in Challenge to EPA&amp;rsquo;s Chrysotile Asbestos Rule&lt;/h3&gt;
&lt;p&gt;On June 1, the Fifth Circuit heard oral argument in consolidated challenges to EPA&amp;rsquo;s 2024 TSCA Section 6(a) risk management rule for chrysotile asbestos. EPA&amp;rsquo;s rule prohibits the manufacture, import, processing, distribution in commerce, and commercial use of chrysotile asbestos for several ongoing uses, including chlor-alkali diaphragms, sheet gaskets in chemical production, oilfield brake blocks, aftermarket automotive brakes and linings, other vehicle friction products, and other gaskets, with phased compliance deadlines and interim workplace controls for certain uses.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Industry petitioners in this case have argued that EPA exceeded its authority by imposing prohibitions beyond what is &amp;ldquo;necessary&amp;rdquo; to address unreasonable risk, while public health petitioners have argued that the rule does not go far enough and should provide broader and faster protections. Prior to oral argument, the Fifth Circuit instructed the parties be prepared to discuss the standing of their respective organizations to challenge the risk management rule.&amp;nbsp; Consistent with this instruction, oral argument focused heavily on standing and the court subsequently requested supplemental briefing from the parties on standing.&amp;nbsp;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;The litigation presents an important early test of EPA&amp;rsquo;s post-2016 TSCA Section 6 risk management authority (beyond the expedited PBT rules), and a decision could have implications beyond asbestos. Depending on whether and how the court addresses EPA&amp;rsquo;s selection of risk management measures, compliance timelines, and the &amp;ldquo;to the extent necessary&amp;rdquo; standard under TSCA Section 6(a), the ruling may influence judicial review of EPA&amp;rsquo;s other final and forthcoming risk management rules for chemicals for which the Agency has identified unreasonable risk.&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;U.S. Supreme Court Weighs FIFRA Preemption of State Pesticide Labeling Laws&lt;/h3&gt;
&lt;p&gt;On April 27, the U.S. Supreme Court heard oral argument in &lt;em&gt;Monsanto Company v. Durnell&lt;/em&gt; (No. 24-1068). This case considers the scope of preemption under FIFRA, including explicit preemption under FIFRA section 24(b) (7 U.S.C. &amp;sect; 136v(b)), which prohibits states from &amp;ldquo;impos[ing] or continu[ing] in effect any requirements for labeling in addition to or different from those required&amp;rdquo; under FIFRA. Specifically, the question at issue in this case is whether a pesticide manufacturer can be held liable under a state &amp;ldquo;failure to warn&amp;rdquo; law for not including a cancer warning on a pesticide label where EPA has concluded that the pesticide does not cause cancer. The Supreme Court&amp;rsquo;s decision in this case will likely have significant impacts on the extent to which federal action under FIFRA preempts state law, and therefore on the availability of preemption as a defense in pesticide litigation under state tort laws.&lt;/p&gt;
&lt;h2&gt;&lt;a name="State Regulatory Updates"&gt;&lt;/a&gt;State Regulatory Updates&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h2&gt;
&lt;h3&gt;New Mexico Finalizes PFAS Consumer Product Regulations&lt;/h3&gt;
&lt;p&gt;New Mexico&amp;rsquo;s Environmental Improvement Board adopted &lt;a rel="noopener noreferrer" href="https://prod-rf-lambda.rtssaas.com/PublicFiles/d89c47bd0d70402dba89b03a22bda6d1/edb0a023-ba9d-43b7-9027-64f003eadfd0/20.13.2new.pdf" target="_blank"&gt;final regulations&lt;/a&gt; implementing the state&amp;rsquo;s PFAS Protection Act, and such regulations were published in the New Mexico Register on May 5. The rule establishes reporting and labeling requirements, as well as currently unavoidable use and enforcement procedures for products containing intentionally added PFAS and is scheduled to take effect on July 1, 2026.&lt;/p&gt;
&lt;p&gt;The regulations implement New Mexico&amp;rsquo;s phased restrictions on PFAS-containing products. Beginning January 1, 2027, the state will prohibit certain products containing intentionally added PFAS, including cookware, food packaging, dental floss, juvenile products, and firefighting foam. The restrictions expand on January 1, 2028, to additional categories, including carpets, cleaning products, cosmetics, fabrics, feminine hygiene products, textiles, ski wax, and upholstered furniture. By January 1, 2032, the law will prohibit all non-exempt products containing intentionally added PFAS unless the use has been determined to be a currently unavoidable use. &lt;/p&gt;
&lt;p&gt;The rule also creates near-term compliance obligations. Manufacturers of non-exempt products or product components containing intentionally added PFAS that are sold, offered for sale, or distributed for sale in New Mexico must submit required reporting information to the New Mexico Environment Department (NMED) on or before January 1, 2027. In addition, after January 1, 2027, manufacturers may not manufacture for sale or distribution a product containing intentionally added PFAS unless the product is labeled in accordance with New Mexico&amp;rsquo;s requirements or the manufacturer documents compliance with corresponding labeling requirements adopted by another state, subject to applicable exemptions. Manufacturers should be aware that many categories of products exempt from the prohibition and reporting requirements under New Mexico&amp;rsquo;s regulations are nonetheless subject to this labeling requirement.&amp;nbsp; &lt;/p&gt;
&lt;p&gt;This rule is notable because it adds another broad state-level PFAS-in-products framework with near-term reporting, labeling, and product-ban deadlines, particularly relevant for companies selling products through national distribution channels. Manufacturers should assess whether products sold or distributed in New Mexico contain intentionally added PFAS and whether reporting, labeling, exemption, or currently unavoidable use strategies may be needed.&lt;/p&gt;
&lt;p&gt;Manufacturers should also monitor pending judicial review of the final rule, which has been appealed to the New Mexico Court of Appeals; absent a stay or other court action, companies should continue preparing for the rule&amp;rsquo;s upcoming compliance deadlines.&lt;/p&gt;
&lt;h3&gt;Minnesota Extends PFAS Product Reporting Deadline&lt;/h3&gt;
&lt;p&gt;The Minnesota Pollution Control Agency (MPCA) has &lt;a rel="noopener noreferrer" href="https://www.pca.state.mn.us/air-water-land-climate/reporting-pfas-in-products" target="_blank"&gt;extended&lt;/a&gt; the initial reporting deadline under the state&amp;rsquo;s PFAS in Products law from July 1, 2026, to September 15, 2026. The reporting requirement applies to manufacturers of products manufactured after July 1, 2023, and sold, offered for sale, or distributed in Minnesota that contain intentionally added PFAS, subject to limited applicable exclusions and exemptions.&lt;/p&gt;
&lt;p&gt;MPCA has also released additional information on requests for a single 90-day reporting extension and requests for reporting waivers where &amp;ldquo;equivalent PFAS in product information is publicly available and verifiable.&amp;rdquo; Extension and waiver requests must be postmarked by August 16, 2026. For manufacturers with approved extension requests, initial reports will be due December 14, 2026.&lt;/p&gt;
&lt;p&gt;The September 15, 2026, reporting deadline gives manufacturers additional time to gather supply chain information and prepare submissions through Minnesota&amp;rsquo;s PFAS Reporting and Information System for Manufacturers (PRISM), but the reporting obligation remains significant. Companies selling products into Minnesota should continue assessing whether their products (or any components of their products) contain intentionally added PFAS, whether any exclusions or waiver arguments may apply, and whether an extension request is warranted before the August 16 deadline.&lt;/p&gt;
&lt;h2&gt;&lt;a name="European Union"&gt;&lt;/a&gt;European Union&lt;/h2&gt;
&lt;h3&gt;European Chemicals Agency Risk Assessment Committee Adopts Opinion on Trifluoroacetic Acid&lt;/h3&gt;
&lt;p&gt;In a &lt;a rel="noopener noreferrer" href="https://echa.europa.eu/documents/d/guest/rac77_final_minutes_en" target="_blank"&gt;summary&lt;/a&gt; of its June 2026 meeting, the European Chemicals Agency&amp;rsquo;s Risk Assessment Committee (RAC) announced that it has adopted an opinion that trifluoroacetic acid (TFA) should be classified as toxic to reproduction. The RAC also adopted an opinion that TFA should be classified as very persistent, very mobile, and toxic. The final RAC opinion is not yet publicly available. The European Commission will now consider the RAC opinion and determine whether to update the listing for TFA under the European Union&amp;rsquo;s Classification, Labeling and Packaging of Chemicals (CLP) regulations. An update to the CLP regulations would impact how suppliers would have to classify and label TFA.&amp;nbsp;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{80FD4F1D-A5E3-48A1-B7D0-92AB79659B3D}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/arnold-porters-2026-seattle-consumer-products-retail-tech-forum</link><a10:author><a10:name>Donal M. O'Brien</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/obrien-donal-m</a10:uri><a10:email>donal.obrien@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Raqiyyah Pippins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pippins-raqiyyah</a10:uri><a10:email>raqiyyah.pippins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Todd L. Nunn</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nunn-todd</a10:uri><a10:email>Todd.Nunn@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>William Hallett Efron</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/efron-william-hallett</a10:uri><a10:email>william.efron@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Meredith Osborn</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/osborn-meredith</a10:uri><a10:email>meredith.osborn@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Daniel E. Raymond</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raymond-daniel</a10:uri><a10:email>daniel.raymond@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sheena Thomas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomas-sheena</a10:uri><a10:email>sheena.thomas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lori B. Leskin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/leskin-lori-b</a10:uri><a10:email>lori.leskin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Paul W. Sweeney, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sweeney-jr-paul-w</a10:uri><a10:email>paul.sweeney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sheila S. Boston</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/boston-sheila-s</a10:uri><a10:email>sheila.boston@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>E. Alex Beroukhim</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/beroukhim-e-alex</a10:uri><a10:email>alex.beroukhim@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Wilson D. Mudge</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mudge-wilson-d</a10:uri><a10:email>Wilson.Mudge@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lynn Fischer Fox</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/fischer-fox-lynn</a10:uri><a10:email>lynn.fischerfox@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ashley E. Gammell</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gammell-ashley</a10:uri><a10:email>Ashley.Gammell@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sean M. SeLegue</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/selegue-sean-m</a10:uri><a10:email>sean.selegue@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>S. Michael Gentine</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gentine-s-michael</a10:uri><a10:email>mike.gentine@arnoldporter.com</a10:email></a10:author><title>Arnold &amp; Porter’s 2026 Seattle Consumer Products, Retail, &amp; Tech Forum</title><description>Arnold &amp;amp; Porter invites you to our inaugural Seattle Consumer Products, Retail, &amp;amp; Tech Forum, a half-day program built for legal and business leaders in the consumer products, retail, and tech industries navigating a rapidly shifting state and federal regulatory landscape.&amp;nbsp;</description><pubDate>Tue, 23 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter invites you to our inaugural Seattle Consumer Products, Retail, &amp;amp; Tech Forum, a half-day program built for legal and business leaders in the consumer products, retail, and tech industries navigating a rapidly shifting state and federal regulatory landscape. Hosted in the U.S. Bank Center, where our Seattle office is located, the forum brings together Arnold &amp;amp; Porter attorneys from across the country alongside senior in-house leaders, including &lt;strong&gt;Marissa John, General Counsel of the Seattle Seahawks, Jolene Marshall, &lt;span&gt;Chief Legal Officer of HighLevel&lt;/span&gt;, Zabrina Jenkins, former General Counsel of Starbucks&lt;/strong&gt;, and&lt;strong&gt; Sara Gattie, Chief Risk Officer of Providence&lt;/strong&gt;, for an afternoon of candid conversation, practical insight, and networking.&lt;/p&gt;
&lt;p&gt;The program will open with a networking lunch and a fireside chat featuring &lt;strong&gt;Laura Clinton, &lt;span&gt;Consumer Protection Division Chief, Washington State Attorney General&amp;rsquo;s Office&lt;/span&gt;&lt;/strong&gt;, whose office has been at the forefront of consumer protection enforcement in the region, reflecting the increasingly important role state attorneys general are playing alongside federal regulators.&lt;/p&gt;
&lt;p&gt;The forum will then feature panel discussions that address the legal and business challenges shaping the consumer products, retail, and technology sectors, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Ethics in artificial intelligence&lt;/li&gt;
    &lt;li&gt;Data &amp;amp; privacy&lt;/li&gt;
    &lt;li&gt;Consumer protection, UDAP litigation, &amp;amp; advertising trends&lt;/li&gt;
    &lt;li&gt;Pricing, antitrust, tariffs, &amp;amp; algorithmic regulation&lt;/li&gt;
    &lt;li&gt;Consumer product compliance and regulatory enforcement trends&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;A networking reception with drinks and passed hors d&amp;rsquo;oeuvres will follow. We look forward to seeing you in Seattle.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1C9BE326-8AF4-4425-A093-1D8BFCB04ABA}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/judicial-foreclosure-and-receivership-as-alternative-remedies-for-washington-lenders-after-vargas</link><a10:author><a10:name>Rhys W. Hefta</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hefta-rhys</a10:uri><a10:email>rhys.hefta@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Matthew J. Micheli</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/micheli-matthew-j</a10:uri><a10:email>matthew.micheli@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Aaron E. Millstein</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/millstein-aaron-e</a10:uri><a10:email>Aaron.Millstein@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christian Scarlett</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/scarlett-christian</a10:uri><a10:email>christian.scarlett@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Owen S. Haney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/haney-owen</a10:uri><a10:email>owen.haney@arnoldporter.com</a10:email></a10:author><title>Judicial Foreclosure and Receivership as Alternative Remedies for Washington Lenders After Vargas</title><description>On April 30, 2026, the Washington Supreme Court ruled in &lt;em&gt;Vargas v. RRA CP Opportunity Trust 1&lt;/em&gt;&amp;nbsp;that only a &amp;ldquo;holder&amp;rdquo; of a negotiable instrument, as contemplated by the Uniform Commercial Code (UCC), can satisfy the prerequisites for conducting a nonjudicial trustee&amp;rsquo;s sale of property under the Washington Deed of Trust Act (DTA).</description><pubDate>Tue, 23 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On April 30, 2026, the Washington Supreme Court ruled in &lt;em&gt;Vargas v. RRA CP Opportunity Trust 1&lt;/em&gt;[[N: &lt;em&gt;Marquez Vargas v. RRA CP Opportunity Tr. 1&lt;/em&gt;, No. 103735-0, 2026 WL 1174062 (Apr. 30, 2026).]]&amp;nbsp;that only a &amp;ldquo;holder&amp;rdquo; of a negotiable instrument, as contemplated by the Uniform Commercial Code (UCC), can satisfy the prerequisites for conducting a nonjudicial trustee&amp;rsquo;s sale of property under the Washington Deed of Trust Act (DTA). As we explained in our &lt;a href="/en/perspectives/advisories/2026/05/washington-supreme-court-limits-remedy-of-nonjudicial-foreclosure"&gt;earlier advisory&lt;/a&gt;&amp;nbsp;examining that decision, &lt;em&gt;Vargas&lt;/em&gt; appears to eliminate the remedy of nonjudicial foreclosure for Washington lenders engaged in a broad range of commercial transactions, including deeds of trust securing certain credit agreements, bond indentures, letters of credit, guaranties, construction loans, and other instruments that, by their nature, provide for a variable principal amount that cannot be specified at the time of their inception. In the wake of &lt;em&gt;Vargas&lt;/em&gt;, lenders should be familiar with the primary alternative remedies available under Washington law: judicial foreclosures and receiverships.&lt;/p&gt;
&lt;h2&gt;Judicial Foreclosure&lt;/h2&gt;
&lt;p&gt;The most direct alternative to a nonjudicial trustee&amp;rsquo;s sale is a judicial foreclosure of the deed of trust as a mortgage under Washington&amp;rsquo;s judicial foreclosure statute, Revised Code of Washington (RCW) 61.12. Judicial foreclosure is a well-established remedy, but it is critical for lenders to consider the process, its practical limitations, and the constraints it places on a lender after the sale.&lt;/p&gt;
&lt;h3&gt;The Process&lt;/h3&gt;
&lt;p&gt;To initiate a judicial foreclosure, the lender files a complaint in the appropriate Superior Court (a Washington state trial court) naming all parties with an interest in the property, including all owners, mortgagors, guarantors, junior lienholders, tenants, and the United States if a federal tax lien exists. &lt;/p&gt;
&lt;p&gt;The complaint should describe the circumstances of the borrower&amp;rsquo;s default, the key terms of the loan documents, a legal description of the property, and the full range of relief the lender seeks, including the right to bid at the foreclosure sale and the right to pursue a deficiency judgment. The lender should also record a notice of &lt;em&gt;lis pendens&lt;/em&gt; in the county where the property is located to provide constructive notice of the action and bind third parties to the outcome of the litigation.[[N: &lt;em&gt;See &lt;/em&gt;RCW 4.28.320.]]&lt;/p&gt;
&lt;p&gt;The lender must then prosecute the litigation. If successful, the lender will obtain a judgment of foreclosure and can then request an order of sale from the county clerk, which authorizes the sheriff&amp;rsquo;s office to conduct a public auction after at least 30 days&amp;rsquo; notice to the judgment debtor.[[N:&amp;nbsp;&lt;em&gt;See&lt;/em&gt; RCW 6.21.030 (detailing notice of sale requirements).]]&lt;/p&gt;
&lt;p&gt;After the auction, the sheriff delivers a copy of the certificate of sale to the purchaser, which reflects the price paid and whether the property is subject to a right of redemption.[[N: &lt;em&gt;See&lt;/em&gt; RCW 6.21.100. No right of redemption exists if the property has been improved by a structure, is not used for agricultural purposes, and the court determines it has been abandoned for six months.]]&lt;/p&gt;
&lt;p&gt;Before the sale may be finalized, the court must confirm it. Before ordering or confirming the sale, the court may hold a hearing to fix an &amp;ldquo;upset price&amp;rdquo; representing the property&amp;rsquo;s minimum value, and may decline to confirm a sale that fails to meet that threshold.[[N: &lt;em&gt;See&lt;/em&gt; RCW 61.12.060. If the court does not set an upset price before confirmation, the court may hold a hearing to establish the property&amp;rsquo;s value and, as a condition to confirmation, require that the fair value of the property be credited upon the foreclosure judgment. &lt;em&gt;Id&lt;/em&gt;.]] Only after confirmation does the court order disbursement of proceeds to lienholders in order of priority.&lt;/p&gt;
&lt;h3&gt;Practical Implications: Time, Cost, and Unpredictability&lt;/h3&gt;
&lt;p&gt;Compared to nonjudicial foreclosure, judicial foreclosure adds procedural complexity, time, and expense. A judicial foreclosure requires litigation, can result in contested proceedings, and typically takes longer to complete than a nonjudicial trustee&amp;rsquo;s sale. The time to implement a judicial foreclosure may increase if the volume of such actions increases materially in the wake of &lt;em&gt;Vargas&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The expense of litigation is also a factor to be considered. Judicial foreclosure requires the lender to bear the costs of filing, service, title search, legal fees, and the attendant costs if the matter is contested. While some of these costs, or the equivalent, would also be incurred in a nonjudicial trustee&amp;rsquo;s sale, it is reasonable to anticipate that the costs incurred in connection with a judicial foreclosure will be significantly higher.&lt;/p&gt;
&lt;h3&gt;The Right of Redemption: A Critical Constraint on Post-Sale Strategy&lt;/h3&gt;
&lt;p&gt;The most significant practical limitation of judicial foreclosure is the borrower&amp;rsquo;s statutory right of redemption. Under RCW 6.23.020, borrowers are generally entitled to redeem the property for a period of one year following the completion of a judicial sale.[[N: The redemption period ends eight months after the sale if the lender waives its right to collect a deficiency and the property is not used for agricultural purposes. RCW 6.23.020(1).]] This right is not merely procedural; it has practical implications for what a lender can do with the property it acquires at a foreclosure sale.&lt;/p&gt;
&lt;p&gt;During the redemption period, the borrower may reacquire the property by paying the full amount of the outstanding debt as of the time of sale, plus interest, taxes, and certain assessments. Critically, the borrower may exercise this right even if the property has been sold or transferred to a third party following the sale.[[N: RCW 6.23.020(1)-(2) (setting forth requirements to redeem from the purchaser).]] This statutory right of redemption may only be relinquished in limited circumstances and cannot be assigned as a naked right free from the redemptioner&amp;rsquo;s underlying interest in the property. [[N: &lt;em&gt;See&lt;/em&gt; footnote 5 describing the limited circumstances of voluntary relinquishment.]][[N: &lt;em&gt;Performance Constr., LLC v. Glenn&lt;/em&gt;, 195 Wash. App. 406, 417 (2016)(&amp;ldquo;[R]eal property can only be conveyed by a valid deed and a valid transfer of an interest in the property&amp;rsquo;s title is necessary to transfer the right of redemption.&amp;rdquo;)]]The right of redemption thus creates a cloud on title that can impair the marketability of the property and the price achieved at the foreclosure sale.&lt;/p&gt;
&lt;p&gt;The right of redemption also creates substantial operational and financial risk for lenders who acquire property at a judicial sale. With very limited exceptions, the owner of the property during the redemption period (the lender or a third-party purchaser) is not entitled to compensation for appreciation in the value of the property or investments made to operate, maintain, or improve the property after the foreclosure sale through the time of redemption. This risk can be particularly acute for properties that require ongoing operational expenditures, capital investment, or completion of construction. &lt;/p&gt;
&lt;h3&gt;The Benefits of a Judicial Foreclosure &lt;/h3&gt;
&lt;p&gt;There are potential benefits related to the judicial foreclosure process that merit consideration. First, in a judicial foreclosure, the lender is entitled to a deficiency judgment under RCW 61.12.080, which enables the lender to pursue guarantors and other obligors for any deficiency in the amount it recovers in the sale. The right to pursue guarantors and other obligors for a deficiency judgment following a nonjudicial trustee&amp;rsquo;s sale in Washington is more limited. Second, the lender may attend and credit bid its claim at the public auction. Third, the lender may request a money judgment against the judgment debtor, guarantor, or other obligor. The lender should request each of the foregoing types of relief in the foreclosure complaint.&lt;/p&gt;
&lt;h2&gt;Receivership &lt;/h2&gt;
&lt;p&gt;To the extent that a judicial foreclosure is not a practical remedy in light of the costs, time, and risks associated with the redemption right, the appointment of a general receiver with the power of sale under RCW 7.60 (the Washington State Receivership Act, or WSRA) is a potentially valuable alternative. A receivership provides a flexible, court-supervised process that can replicate the practical benefits of a nonjudicial foreclosure and provide other tools that may be unavailable in either the judicial or nonjudicial foreclosure context.&lt;/p&gt;
&lt;h3&gt;Types of Receivers and Initiating the Process&lt;/h3&gt;
&lt;p&gt;Under the WSRA, a receiver may be either &amp;ldquo;custodial&amp;rdquo; or &amp;ldquo;general&amp;rdquo; in nature. A custodial receiver administers only select assets designated by the court. By contrast, a general receiver displaces management of the subject business or property entirely and is empowered to administer and dispose of all estate assets for the benefit of the estate.[[N: Although the Washington receivership statute does not define &amp;ldquo;estate assets,&amp;rdquo; an order appointing a general receiver over all estate assets would include &amp;ldquo;all right, title, and interests, both legal and equitable, . . . in or with respect to any property of a person with respect to which a receiver is appointed . . . .&amp;rdquo;&lt;em&gt; See&lt;/em&gt; RCW 7.60.005(3), (9). To resolve the administration of property beyond the jurisdiction of the court, the receiver may bring ancillary proceedings in&amp;nbsp;foreign jurisdictions requesting recognition of the Washington receivership.&lt;em&gt; See&lt;/em&gt; RCW 7.60.270(1).]] For lenders seeking to maximize control and flexibility in a distressed scenario, appointment of a general receiver will ordinarily be the preferred option.&lt;/p&gt;
&lt;p&gt;Receivership proceedings are initiated by filing a petition in the appropriate Superior Court. The petition must identify the type of receiver sought, the grounds for appointment, and the identity of the proposed receiver.[[N: A receiver may not be, among other things, &amp;ldquo;a party to the action, a . . . director, officer, agent, attorney, employee, secured or unsecured creditor or lienor of, or holder of any equity interest in . . . the person whose property is to be held by the receiver . . . .&amp;rdquo; RCW 7.60.035.]] It should be supported by declarations from the petitioner and the prospective receiver establishing the factual basis for the appointment and the receiver&amp;rsquo;s qualifications. The receiver must post bond in an amount set by the court before assuming its duties.[[N: &lt;em&gt;See&lt;/em&gt; RCW 7.60.045.]] The WSRA provides thirty-three distinct statutory grounds upon which a receiver may be appointed,[[N: &lt;em&gt;See&lt;/em&gt; RCW 7.60.025(1)(a)-(nn).]] including, among others: danger of material loss or injury to the property or its revenue-producing potential (RCW 7.60.025(1)(b)(i)); the need to enforce an assignment of rents (RCW 7.60.025(1)(b)(ii)); the need to preserve and protect property pending execution (RCW 7.60.025(1)(e)); and insolvency or imminent danger of insolvency (RCW 7.60.025(1)(i)). The WSRA also allows for the appointment of a receiver where such appointment &amp;ldquo;is provided for by agreement&amp;rdquo; (RCW 7.60.025(1)(b)(ii)). Except where appointment is expressly mandated by statute, the court may only appoint a receiver if it finds that appointment is &amp;ldquo;reasonably necessary&amp;rdquo; and that other available remedies are inadequate. &lt;em&gt;See&lt;/em&gt; RCW 7.60.025(1).&lt;/p&gt;
&lt;h3&gt;Key Powers of a General Receiver&lt;/h3&gt;
&lt;p&gt;Once appointed, a general receiver under the WSRA exercises a broad range of powers that can be of substantial benefit to lenders and can operate in ways that parallel certain protections available under the United States Bankruptcy Code.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Automatic Stay&lt;/em&gt;. Under RCW 7.60.110, the entry of an order appointing a receiver automatically stays for sixty days, among other actions, the commencement or continuation of legal proceedings against the receivership estate, the enforcement of judgments, and any act to obtain possession of or interfere with estate property. The stay may be extended by the court for good cause shown. This breathing spell can help protect a lender&amp;rsquo;s rights and collateral by halting the efforts of competing creditors, preventing the dissipation of assets, and creating an environment in which the lender can assess the property and formulate a strategy without the pressure of parallel enforcement actions.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Management Displacement and Operational Control&lt;/em&gt;. A general receiver appointed over an operating business or property has authority to &amp;ldquo;do all things which the owner of the business or property might do in the ordinary course of the operation of the business,&amp;rdquo; including purchasing goods, incurring expenses, and paying certain pre-receivership claims.[[N: RCW 7.60.060.]] The receiver may compel by subpoena any person to submit to examination and may demand, under threat of contempt of court, the turnover of estate property. These powers allow lenders to replace management, stabilize the property&amp;rsquo;s operations, and seek a value-maximizing disposition without the delays and uncertainties of litigation.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Free and Clear Sales&lt;/em&gt;. Perhaps the most compelling feature of the receivership remedy for lenders confronting the limitations of judicial foreclosure is the general receiver&amp;rsquo;s authority to conduct sales free and clear of liens and rights of redemption. Following notice and a hearing, a court may order the sale of property &amp;ldquo;free and clear of liens and rights of redemption . . . whether or not the sale will generate proceeds sufficient to fully satisfy all claims secured by the property.&amp;rdquo;[[N:&amp;nbsp;See RCW 7.60.260.]] The receivership statute eliminates the right of redemption that attaches to judicial sales. Security interests encumbering the property transfer and attach to the proceeds of the sale, net of the receiver&amp;rsquo;s reasonable expenses incurred in the disposition of the property.[[N: It should be noted that the authority to sell free and clear does not extend to homesteads, property used in agriculture, or, if a creditor objects, sales likely to recover less than the property would realize in a reasonable time absent the sale.]]&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Credit Bidding&lt;/em&gt;. As in bankruptcy proceedings, a secured creditor may credit bid its claims at a receiver&amp;rsquo;s sale, provided it can satisfy, in cash, all secured claims senior to its secured claims in full.[[N: RCW 7.60.260(3).]]&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Deficiency Judgments&lt;/em&gt;. The WSRA does not prohibit lenders from pursuing deficiency judgments following a receiver&amp;rsquo;s sale.[[N: The Washington Court of Appeals has twice rejected arguments that the WSRA precludes a secured creditor from pursuing a post-sale deficiency judgment. &lt;em&gt;See Umpqua Bank v. Shasta Apartments, LLC&lt;/em&gt;, 194 Wash. App. 685 (2016); &lt;em&gt;MUFG Union Bank, N.A. v. Campadore&lt;/em&gt;, 198 Wash. App. 1006 (2017).]]  &lt;/p&gt;
&lt;p&gt;&lt;em&gt;Receivership Financing&lt;/em&gt;. A general receiver may seek court approval for receivership financing secured by estate property,[[N: The receiver may also obtain unsecured credit in the ordinary course of business without court authorization. See RCW 7.60.140.]]&amp;nbsp;enabling the receiver to fund necessary operations, repairs, or improvements during the pendency of the receivership. &lt;/p&gt;
&lt;h3&gt;Potential Limitations of Receivership&lt;/h3&gt;
&lt;p&gt;Receivership is not without its drawbacks, and lenders should weigh these against the potential advantages.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Cost and Administrative Burden&lt;/em&gt;. Receivers may retain attorneys, accountants, and other professionals whose fees and costs constitute administrative expenses that must be paid in full before any distributions to creditors. Receivers must also prepare a final report cataloging all receipts and disbursements before they may be discharged by the court. In complex cases, these costs can add up and may reduce the net recovery available to the lender.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Court Supervision and Unpredictability&lt;/em&gt;. Receivership proceedings are public and court-supervised. All parties with an interest in estate property or in the proceedings may appear and be heard on almost any issue, which borrowers can use to complicate the proceedings and cause delay.&lt;/p&gt;
&lt;p&gt;The collective and widely publicized nature of a receivership can complicate a lender&amp;rsquo;s strategy, invite competing claims, and generate unforeseen litigation.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;No Prohibition on Filing Bankruptcy&lt;/em&gt;. Nothing in the WSRA forbids an entity from seeking bankruptcy protection while under receivership. Nevertheless, an order appointing a general receiver may divest the officers and directors of the company of the requisite authority to file bankruptcy petitions on the company&amp;rsquo;s behalf.[[N: &lt;em&gt;See In re Sino Clean Energy, Inc.&lt;/em&gt;, 901 F.3d 1139 (9th Cir. 2018). If the bankruptcy petition succeeds, the receiver must turnover property to the bankruptcy trustee and file an accounting of property that came into its possession with the bankruptcy court. 11 U.S.C. &amp;sect; 543(b).]] In any case, an unauthorized bankruptcy filing may lead to unwanted litigation and expense for the receivership estate.&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;In the wake of &lt;em&gt;Vargas&lt;/em&gt;, lenders should carefully consider the strategic implications of the available alternatives for resolving distressed scenarios in Washington. Judicial foreclosures and receiverships are both powerful tools, and post-&lt;em&gt;Vargas&lt;/em&gt;, we expect that receiverships will increasingly be relied upon by lenders. &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F6E7E2C5-0A4A-4BD4-B2D9-2E00620E6BCF}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/us-fto-designations-of-brazilian-criminal-organizations-legal-compliance</link><a10:author><a10:name>Carlos Lobo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lobo-carlos</a10:uri><a10:email>carlos.lobo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ambassador Thomas A. Shannon, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shannon-thomas</a10:uri><a10:email>tom.shannon@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tal R. Machnes</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/machnes-tal-r</a10:uri><a10:email>Tal.Machnes@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eric Snyder</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/snyder-eric</a10:uri><a10:email>eric.snyder@arnoldporter.com</a10:email></a10:author><title>U.S. FTO Designations of Brazilian Criminal Organizations: Legal, Compliance, and Geopolitical Implications</title><description>Arnold &amp;amp; Porter invites you to a complimentary briefing on a fast-moving development with significant implications for businesses operating in Brazil.</description><pubDate>Mon, 22 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter invites you to a complimentary briefing on a fast-moving development with significant implications for businesses operating in Brazil. On May 28 and June 5, 2026, the U.S. Department of State designated two of Brazil&amp;rsquo;s largest criminal organizations, Primeiro Comando da Capital (PCC) and Comando Vermelho (CV), as Specially Designated Global Terrorists (SDGTs) and Foreign Terrorist Organizations (FTOs), respectively. These are the first Brazilian entities to be placed on the U.S. FTO list, following similar designations of eight Mexican and Latin American criminal organizations in February 2025, and reflect a broader shift in U.S. policy toward addressing drug trafficking threats through a counterterrorism framework, with significant downstream legal and commercial risks.&lt;/p&gt;
&lt;p&gt;The consequences are immediate and far-reaching: asset freezes, prohibitions on transactions with any nexus to the United States, potential civil liability under the Anti-Terrorism Act, criminal liability for providing material support to either organization, including through supply chains and third-party relationships, among others. Companies operating in Brazil, particularly in financial services, energy, logistics, and construction, face direct exposure.&lt;/p&gt;
&lt;p&gt;Our panel will address the following:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The geopolitical context: the PCC and CV designations within the Trump Administration&amp;rsquo;s broader counterterrorism strategy in Latin America, and what to expect next.&lt;/li&gt;
    &lt;li&gt;SDGT v. FTO: the distinct legal frameworks, OFAC compliance obligations, and what the designations mean for U.S. and non-U.S. companies with Brazil exposure.&lt;/li&gt;
    &lt;li&gt;Scope of the material support prohibition and related compliance obligations, including supply chain and third-party exposure.&lt;/li&gt;
    &lt;li&gt;Indirect exposure risks: how liability can arise through intermediaries, customers, and financial flows&amp;mdash;even without direct dealings with designated organizations.&lt;/li&gt;
    &lt;li&gt;Criminal enforcement dimensions: DOJ prosecution strategy, corporate liability, and lessons from prior FTO enforcement actions.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The briefing will be followed by a Q&amp;amp;A session. Please send any questions or topics you would like the panel to address to &lt;a href="mailto:carlos.lobo@arnoldporter.com"&gt;carlos.lobo@arnoldporter.com&lt;/a&gt; in advance. Arnold &amp;amp; Porter hopes you will join us!&lt;/p&gt;
&lt;h2&gt;Speakers&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Carlos Lobo&lt;/strong&gt;&lt;/li&gt;
    Partner, Corporate &amp;amp; Finance | Latin America &amp;amp; Caribbean&lt;br /&gt;
    Arnold &amp;amp; Porter, New York&lt;br /&gt;
    &lt;em&gt;Introduction &amp;amp; Moderator&lt;/em&gt;&lt;br /&gt;
    &lt;br /&gt;
    &lt;li&gt;&lt;strong&gt;Ambassador Thomas A. Shannon, Jr.&lt;/strong&gt;&lt;/li&gt;
    Senior International Policy Advisor, Global Law &amp;amp; Public Policy | Latin America &amp;amp; Caribbean&lt;br /&gt;
    Arnold &amp;amp; Porter, Washington, D.C.&lt;br /&gt;
    &lt;em&gt;Former Under Secretary of State for Political Affairs; former U.S. Ambassador to Brazil&lt;/em&gt;&lt;br /&gt;
    &lt;br /&gt;
    &lt;li&gt;&lt;strong&gt;John P. Barker&lt;/strong&gt;&lt;/li&gt;
    Partner, Government Contracts and National Security | Export Controls &amp;amp; Sanctions | Latin America &amp;amp; Caribbean&lt;br /&gt;
    Arnold &amp;amp; Porter, Washington, D.C.&lt;br /&gt;
    &lt;em&gt;Former Deputy Assistant Secretary of State for Export Controls&lt;/em&gt;&lt;br /&gt;
    &lt;br /&gt;
    &lt;li&gt;&lt;strong&gt;Tal R. Machnes&lt;/strong&gt;&lt;/li&gt;
    Counsel, White Collar Defense &amp;amp; Investigations | OFAC &amp;amp; Export Controls&lt;br /&gt;
    Arnold &amp;amp; Porter, New York&lt;br /&gt;
    &lt;br /&gt;
    &lt;li&gt;&lt;strong&gt;Eric Snyder&lt;/strong&gt;&lt;/li&gt;
    Partner, White Collar Defense &amp;amp; Investigations | Latin America &amp;amp; Caribbean&lt;br /&gt;
    Arnold &amp;amp; Porter, New York&lt;br /&gt;
    &lt;em&gt;Former Assistant U.S. Attorney, Southern District of New York&lt;/em&gt;&lt;br /&gt;
    &lt;br /&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{8846DE46-DA15-4CF2-BC4F-020BE8161C81}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/stephanie-kang-rejoins-arnold-porter-los-angeles-litigation-team</link><title>Stephanie Kang Rejoins Arnold &amp; Porter Los Angeles Litigation Team</title><description>Arnold &amp;amp; Porter announced today that Stephanie Kang has rejoined the firm&amp;rsquo;s Complex Litigation practice as counsel, resident in Los Angeles, continuing the firm&amp;rsquo;s West Coast growth.</description><pubDate>Mon, 22 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter announced today that Stephanie Kang has rejoined the firm&amp;rsquo;s Complex Litigation practice as counsel, resident in Los Angeles, continuing the firm&amp;rsquo;s West Coast growth.&lt;/p&gt;
&lt;p&gt;Stephanie previously spent more than eight years at Arnold &amp;amp; Porter, representing clients in complex commercial litigation in state and federal courts. She has extensive experience in all stages of litigation, including case strategy, discovery, depositions, motions, trial preparation, settlements, and appeals. Stephanie has since served as Deputy General Counsel, Litigation at City of Hope, a non-profit NCI-designated cancer research and treatment center. In that role, she directed and managed all aspects of the organization&amp;rsquo;s legal claims, disputes, and litigation portfolio, including defending against cases spanning multiple jurisdictions.&lt;/p&gt;
&lt;p&gt;Stephanie earned her J.D. from the University of California, Los Angeles School of Law and her B.A., &lt;em&gt;cum laude&lt;/em&gt;, from Scripps College.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{93B2E546-D1FA-4E2B-B826-EB17E9F010FA}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/moving-at-pace-the-cmas-use-of-new-uk-consumer-protection-powers-and-what-to-expect-in-year-2</link><a10:author><a10:name>Nicola Chesaites</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chesaites-nicola</a10:uri><a10:email>nicola.chesaites@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ludovica Pizzetti</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pizzetti-ludovica</a10:uri><a10:email>ludovica.pizzetti@arnoldporter.com</a10:email></a10:author><title>Moving At Pace: the CMA’s Use of New UK Consumer Protection Powers and What to Expect In Year 2</title><description>In April 2025, the Competition and Markets Authority (CMA) acquired new powers to enforce consumer rights under the Digital Markets, Competition and Consumers Act 2024 (DMCCA). The CMA has deployed these new powers at pace in the first fourteen months. We set out below a short recap of these new powers, a summary of the CMA&amp;rsquo;s enforcement to date, and what to expect in Year 2.</description><pubDate>Mon, 22 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;In April 2025, the Competition and Markets Authority (CMA) acquired new powers to enforce consumer rights under the Digital Markets, Competition and Consumers Act 2024 (DMCCA). The CMA has deployed these new powers at pace in the first fourteen months. It has imposed a &amp;pound;4.2 million fine combined with an order to refund &amp;pound;760,000 to consumers for drip-pricing practices; imposed a &amp;pound;720,000 fine combined with an order to refund &amp;pound;600,000 to consumers for automatic opt-in charges; issued 157 advisory and warning letters; sent 46 information notices (and imposed a substantial fine for non-compliance); opened investigations into 14 businesses, and settled with two others. This sends a clear message to businesses to expect swift and active enforcement of consumer protection in the UK under the new regime. We set out below a short recap of these new powers, a summary of the CMA&amp;rsquo;s enforcement to date, and what to expect in Year 2. &lt;/p&gt;
&lt;h2&gt;Recap of the CMA&amp;rsquo;s New Consumer Protection Powers&lt;/h2&gt;
&lt;p&gt;The DMCCA has fundamentally reshaped consumer rights enforcement in the UK. It gave the CMA direct enforcement powers to determine whether consumer rights have been breached and to impose sanctions directly, without first seeking a court determination. The CMA&amp;rsquo;s investigation and fining powers under consumer protection rules now broadly align with those available for competition law enforcement, and include additional enhanced remedial consumer redress tools. These include the power to:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Conduct dawn raids, send formal information requests, and impose penalties of up to 1% of global annual turnover and additional daily penalties for non-compliance with such requests;&lt;/li&gt;
    &lt;li&gt;Impose fines of up to &amp;pound;300,000 or 10% of global annual turnover (whichever is higher) for substantive breaches;&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Impose &amp;ldquo;Enhanced consumer measures&amp;rdquo; (i.e., conduct requirements, such as mandatory consumer compensation) and &amp;ldquo;online interface notices&amp;rdquo; (i.e., orders to change online interfaces, such as to modify or remove online content);&lt;/li&gt;
    &lt;li&gt;Apply criminal sanctions for certain breaches; and&lt;/li&gt;
    &lt;li&gt;Agree settlements, accept undertakings, and impose fines for any breach of those undertakings.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The unfair commercial practices (UCPs) prohibited under the DMCCA remain substantially unchanged, albeit the DMCCA clarifies the rules, streamlines, and removes certain tests, making it easier to establish a breach. In summary, UCPs are practices that are &amp;ldquo;&lt;em&gt;likely to cause the average consumer to take a transactional decision that the consumer would not have taken otherwise&lt;/em&gt;&amp;rdquo; as a result of a misleading action, omission, aggressive practice, or a contravention of the requirements of &amp;ldquo;&lt;em&gt;professional diligence&lt;/em&gt;&amp;rdquo;. The DMCCA also specifies 32 commercial practices that are considered unfair in all circumstances and prohibits the omission of material information from an invitation to purchase. Further new rules on subscription traps are expected in Spring 2027. Most of these practices were already unlawful under preexisting law. Still, the DMCCA now expressly prohibits drip pricing (i.e., adding hidden mandatory charges late in the purchasing journey) and fake or misleading reviews. &lt;/p&gt;
&lt;h2&gt;The CMA&amp;rsquo;s Enforcement Activity to Date&lt;/h2&gt;
&lt;p&gt;In the last fourteen months, the CMA has conducted a review of 400 businesses across 19 sectors, focusing primarily on three priority areas: drip pricing, fake reviews, and online choice architecture, with the stated aim of targeting the most serious breaches in sectors that matter most to household spending.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;Drip pricing&lt;/span&gt;. The CMA was most active in relation to drip pricing. In April 2026, it imposed a &amp;pound;4.2 million fine on AA Driving School (Automobile Association Development Limited), accompanied by an order to refund over &amp;pound;760,000 to some 80,000 learner drivers for failing to include a mandatory &amp;pound;3 booking fee in the upfront price. The fine would have been much higher, but AA Driving School received a 40% reduction for early admission and settlement.&lt;/p&gt;
&lt;p&gt;This fine could well be dwarfed in the near future if the CMA&amp;rsquo;s investigation into Ryanair, opened on June 10, 2026, results in a finding of infringement. In this case, the CMA is investigating Ryanair&amp;rsquo;s &amp;pound;8 additional booking fee for a &amp;ldquo;mandatory family seat&amp;rdquo; to secure an adjacent seat for a child aged 2-11, including whether the fee is presented upfront or is &amp;ldquo;dripped&amp;rdquo; later in the booking process.&lt;/p&gt;
&lt;p&gt;The CMA has four additional drip pricing investigations ongoing, opened in November 2025, against two secondary ticketing sites, StubHub and Viagogo, as well as Gold&amp;rsquo;s Gym and BSM Driving School. It has issued warning letters to 100 businesses regarding drip pricing, suggesting there may be further enforcement on this issue in the coming months if the CMA&amp;rsquo;s concerns are not addressed. &lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;Fake reviews&lt;/span&gt;. Continuing its work in recent years on fake online reviews, in March 2026, the CMA opened formal investigations into five businesses for suspected fake and misleading reviews, namely Autotrader, Feefo, Dignity, Just Eat, and Pasta Evangelists. This followed warning letters sent to 54 businesses in July 2025.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;Online choice architecture&lt;/span&gt;. On June 18, 2026, the CMA imposed a fine of &amp;pound;720,000 on Marks Electrical plus an order to refund around &amp;pound;600,000 to around 40,000 customers for automatically opting customers in to purchasing additional services when buying its appliances. As in the case concerning AA Driving School (see above), Marks Electrical received a 40% reduction for early admission and settlement. The CMA has two additional investigations ongoing, opened in November 2025, concerning time-limited sales and/or default opt-ins in the household goods sector against Wayfair and Appliances Direct. &lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;Other conduct&lt;/span&gt;. Beyond these three areas, the CMA launched an investigation into early cancellation fees in March 2026. Separately, in February 2026, the CMA issued a fine of &amp;pound;473,000 for failing to comply with an information notice, which demonstrates that even procedural non-compliance carries its own significant risk.&lt;/p&gt;
&lt;h2&gt;What to Expect in Year 2&lt;/h2&gt;
&lt;p&gt;The CMA has been explicit about its Year 2 priorities, which are: &lt;strong&gt;price transparency&lt;/strong&gt;, &lt;strong&gt;fake reviews&lt;/strong&gt;, &lt;strong&gt;consumer contract terms&lt;/strong&gt; (including subscription contracts where new rules come into force in Spring 2027), and &lt;strong&gt;AI and its deployment by businesses&lt;/strong&gt;. For in-house teams, the immediate practical steps are to ensure pricing is transparent and all-inclusive from the outset, review policies around online reviews for authenticity and accuracy, audit consumer-facing contracts (including exit and cancellation fee provisions) against the CMA&amp;rsquo;s most recent guidance, and consider how AI-generated or AI-assisted customer interactions are disclosed and governed.&lt;/p&gt;
&lt;p&gt;Businesses that received warning letters last year in key areas of consumer spending &amp;ndash; including operators in train and bus travel, cinemas, parcel delivery, and food and drink delivery &amp;ndash; could face a formal investigation if they do not bring their practices into line.&lt;/p&gt;
&lt;p&gt;Where the application of the law is genuinely uncertain, businesses should engage early and proactively with the CMA, which has clearly signaled its openness to dialogue with stakeholders and its willingness to provide bespoke and practical guidance.&lt;/p&gt;
&lt;h2&gt;An attractive enforcement tool for the CMA&lt;/h2&gt;
&lt;p&gt;The new consumer protection regime equips the CMA with investigative and fining powers akin to those under the competition regime, but enforcing it will potentially be far easier and quicker. This is because establishing a UCP does not require complex and detailed economic analyses of market definition and dominance, as is required in competition investigations, which often run for years. By comparison, the CMA&amp;rsquo;s first consumer protection settlement case and fine against AA Driving School was concluded in less than five months. That pace, combined with fines of up to 10% of global turnover, makes consumer protection enforcement an efficient and high-impact &amp;mdash;&amp;nbsp;and therefore attractive &amp;mdash;&amp;nbsp;tool for the CMA to deploy. Given the parallels between the investigative and enforcement powers under the consumer protection and competition regimes, a question that arises is whether the CMA may be able to address certain types of conduct through the consumer protection regime rather than pursuing conduct as an abuse of dominance. Enforcement of this type would be limited to consumer-facing conduct; there, examples of the kind of conduct that theoretically might be capable of being pursued under both regimes could be excessive pricing, as well as tying and bundling. However, it seems such conduct would need to be combined with opacity/ a lack of transparency or aggressive practices (such as exploitation of vulnerable consumers) in order to constitute a UCP. Also, the practice would need to be &amp;ldquo;likely to cause the average consumer to take a transactional decision that the consumer would not have taken otherwise&amp;rdquo;. Given these difficulties, the CMA may not be tempted to seek to deploy its new powers in this way, at least in the short term. In the meantime, given the pace set in the first fourteen months, the number of current ongoing investigations, and an ambitious set of priorities for Year 2 (including in relation to the deployment of AI by businesses), the next ten months will be interesting.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F722A330-FC82-4A67-9087-D02F2401050F}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/pinnacle-women-insights-names-kathleen-harris-among-top-10-admired-women-leaders</link><title>Pinnacle Women Insights Names Kathleen Harris Among Top 10 Admired Women Leaders</title><description>Arnold &amp;amp; Porter partner Kathleen Harris, who heads the firm's London office, was named one of &lt;em&gt;Pinnacle Women Insights&lt;/em&gt;&amp;rsquo; "Top 10 Admired Women Leaders," recognizing accomplished women leaders driving meaningful impact within their organizations and industries.</description><pubDate>Thu, 18 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Kathleen Harris, who heads the firm's London office, was named one of &lt;em&gt;Pinnacle Women Insights&lt;/em&gt;&amp;rsquo; "Top 10 Admired Women Leaders," recognizing accomplished women leaders driving meaningful impact within their organizations and industries.&lt;/p&gt;
&lt;p&gt;In its &lt;a rel="noopener noreferrer" href="https://pinnaclewomeninsights.com/Kathleen-Harris-Partner-of-Arnold-&amp;amp;-Porter-Kaye-Scholer-Certified-as-Top-10-Admired-Women-Leaders-of-2026-by-PWI.php" target="_blank"&gt;profile&lt;/a&gt;, &lt;em&gt;Pinnacle Women Insights&lt;/em&gt; highlights Kathleen&amp;rsquo;s leadership of the London office, her internationally recognized legal practice, and her commitment to expanding access to the legal profession. The publication describes Kathleen&amp;rsquo;s career as one &amp;ldquo;built on purpose, principle, and the power of opportunity&amp;rdquo; and recognizes her efforts to broaden pathways into the legal profession through various initiatives. &lt;em&gt;Pinnacle Women Insights&lt;/em&gt; further notes that Kathleen&amp;rsquo;s journey demonstrates &amp;ldquo;what can happen when talent meets purpose, when leadership is rooted in values, and when opportunity is treated not as a privilege but as a responsibility.&amp;rdquo;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{447789AE-1CA1-4D4D-8554-962F9E92844D}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/china-strengthens-management-of-medical-representatives</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Siyi Gu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gu-siyi</a10:uri><a10:email>siyi.gu@cn.arnoldporter.com</a10:email></a10:author><title>China Finalizes Regulations for Pharmaceutical Sales Representatives</title><description>China&amp;rsquo;s 2026 Management Measures for Medical Representatives significantly expand pharmaceutical compliance obligations by imposing stricter oversight on medical representatives, Marketing Authorization Holders, and third-party sales organizations. The regulations strengthen anti-bribery and anti-fraud enforcement, require enhanced monitoring of promotional activities and healthcare institution interactions, and introduce new compliance, registration, and due diligence requirements that pharmaceutical companies operating in China should address before the rules take effect on August 1, 2026.</description><pubDate>Thu, 18 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;On May 7, 2026, China&amp;rsquo;s National Medical Products Administration (NMPA), in conjunction with six other government agencies,[[N:These government agencies include: National Health Commission, National Healthcare Security Administration, Ministry of Public Security, State Administration for Market Regulation, National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration.]] issued the &lt;a rel="noopener noreferrer" href="https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260507180422166.html" target="_blank"&gt;Management Measures for Medical Representatives&lt;/a&gt; (Management Measures, &lt;span&gt;医&lt;/span&gt;&lt;span&gt;药代表管理办法&lt;/span&gt;), which will take effect on August 1, 2026.&lt;/p&gt;
&lt;p&gt;The Management Measures represent a long anticipated and significant development in China&amp;rsquo;s regulatory framework for the pharmaceutical industry. The Management Measures are the final version of the Draft Management Measures for Medical Representatives, which were published for public comment in November 2024 (2024 Draft, &lt;span&gt;医&lt;/span&gt;&lt;span&gt;药代表管理办法&lt;/span&gt;(&lt;span&gt;征求意&lt;/span&gt;&lt;span&gt;见稿&lt;/span&gt;)),[[N:For further analysis of the Draft Management Measures, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2024/12/the-new-draft-administrative-measures-for-management" target="_self"&gt;China&amp;rsquo;s New Draft Administrative Measures for Management of Medical Representatives&lt;/a&gt;.]] and replace the December 2020 Management Measures for Record-Filing of Medical Representatives (Trial Version) (2020 Trial Measures, &lt;span&gt;医&lt;/span&gt;&lt;span&gt;药代表备案管理办法&lt;/span&gt;(&lt;span&gt;试行&lt;/span&gt;)).&lt;/p&gt;
&lt;p&gt;In this Advisory, we summarize key changes and their implications for industry. Pharmaceutical companies operating in China should assess their compliance posture, particularly their policies for and monitoring of their sales force. While the Management Measures do not apply to the medical device and medtech sector, the NMPA has announced that similar regulations for the medical device and medtech sector are forthcoming, so companies in the sector should view the Management Measures as a preview of coming regulations.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;The Management Measures generally maintain the overall structure of the 2024 Draft, with some important adjustments and a few clarifications, and represent a significant change over the 2020 Trial Measures, which are still currently in effect.&lt;/p&gt;
&lt;p&gt;While the 2020 Trial Measures primarily focus on the record-filing process for medical representatives and their promotional activities, the Management Measures are more comprehensive, covering not only the conduct of medical representatives, but also that of Marketing Authorization Holders (MAHs), healthcare institutions, and healthcare providers. This is consistent with Chinese regulators&amp;rsquo; continued emphasis on end-to-end compliance management.&lt;/p&gt;
&lt;h2&gt;MAHs: Increased Supervisory Liabilities&lt;/h2&gt;
&lt;p&gt;One significant change from the 2024 Draft is restoring requirements found in the 2020 Trial Measures relating to third-party professional services organizations engaged by MAHs to promote the sale of drugs, such as contract sales organizations (CSOs). This change shows that regulators recognize the practice of using CSOs,[[N:Article 3 of the 2026 Management Measures defines medical representatives as &amp;#91p&amp;#93ractitioners who are employed or authorized by MAHs to deliver, communicate, and provide feedback on drug information to healthcare institutions and their staff, and engage in drug academic promotion activities.&amp;rdquo; ]] which was previously a grey area. When engaging CSOs, MAHs are required to assess the CSOs&amp;rsquo; capabilities, include compliance requirements and liabilities for breach of contract in their service contracts, and execute contracts for the management of medical representatives. (Article 8.2) The Management Measures also formally impose compliance requirements on professional services organizations, which largely parallel the obligations imposed on MAHs, e.g., not to retain medical representatives with a record of commercial bribery. (Article 12)&lt;/p&gt;
&lt;p&gt;Another notable revision in the Management Measures is a prohibition on MAHs and professional services organizations &amp;ldquo;condoning&amp;rdquo; (&lt;span&gt;纵容&lt;/span&gt;) medical representatives&amp;rsquo; illegal activities. (Article 11) The 2024 Draft prohibited MAHs from directing illegal activities. This expansion from regulation of MAHs&amp;rsquo; affirmative misconduct to include tolerance of employees&amp;rsquo; misconduct may be intended to restrict MAH&amp;rsquo;s ability to evade corporate liability.&lt;/p&gt;
&lt;p&gt;Other new obligations placed on MAHs in the 2024 Draft are generally preserved in the Management Measures. For instance, MAHs are prohibited from employing or authorizing medical representatives who are unqualified or have records of commercial bribery (Article 11), and are required to ensure that their medical representatives sign compliance commitment letters. (Article 15)&lt;/p&gt;
&lt;h2&gt;Medical Representatives: Requirements and Prohibitions&lt;/h2&gt;
&lt;p&gt;The Management Measures generally maintain the restrictions on medical representatives&amp;rsquo; conduct introduced in the 2024 Draft. For example, medical representatives are prohibited from providing kickbacks or other improper benefits to healthcare professionals (HCPs) and/or persons with close relationships to HCPs, such as family members or close friends. In addition, the Management Measures adjust the requirements for what information should be submitted on the Record-Filing Platform (the Platform), and lowered the requirements for medical representatives&amp;rsquo; academic qualifications and professional experience.&lt;/p&gt;
&lt;p&gt;The Management Measures contain stronger protections for patient privacy. While the 2024 Draft prohibited medical representatives&amp;rsquo; unauthorized disclosure of patient information, the Management Measures further prohibit medical representatives&amp;rsquo; illegally collecting, using, and/or disseminating patient information. This is an important expansion, and aligns with recent enforcement actions targeting medical representatives for improperly obtaining patients&amp;rsquo; personal information.&lt;/p&gt;
&lt;p&gt;The Management Measures provide that medical representatives are required to register at healthcare institutions when first conducting promotional activities, a change from the 2020 Trial Measures, which only required medical representatives to obtain healthcare institutions&amp;rsquo; consent to promotional activities. Given this change from a consent-based framework for promotional activities to a registration-based framework, companies may wish to review their internal approval processes for promotional activities taking place at healthcare institutions, including HCP visits and departmental meetings.&lt;/p&gt;
&lt;h2&gt;Enhanced Enforcement Measures&lt;/h2&gt;
&lt;p&gt;The Management Measures maintains the 2024 Draft provisions explicitly setting forth mechanisms for cooperation among various government authorities in monitoring and investigating misconduct by MAHs, medical representatives, HCPs, and healthcare institutions. In addition to delineating the scope of responsibilities for each government authority, such as the social credit evaluations conducted by healthcare security administrations,[[N:For further analysis of the Credit Evaluation System, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/06/china-compliance-update-life-sciences-summer-2025" target="_self"&gt;China Compliance Update: Life Sciences &amp;mdash; Summer 2025&lt;/a&gt;.]] the Management Measures require collaboration and information sharing among authorities, which further aligns with recent enforcement trends.[[N:For key observations from enforcement actions in 2025, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/03/china-life-sciences-2025-year-in-review" target="_self"&gt;China Life Sciences: 2025 Year in Review&lt;/a&gt;.]]&lt;/p&gt;
&lt;p&gt;The Management Measures retain the 2024 Draft&amp;rsquo;s emphasis on commercial bribery as a primary target for regulatory enforcement, and add &amp;ldquo;fraud&amp;rdquo; as another area of focus.[[N:For example, Article 12 prohibits professional organizations from instructing or condoning medical representatives to engage in &amp;ldquo;illegal and criminal activities such as commercial bribery and fraud.&amp;rdquo;]] This addition of &amp;ldquo;fraud&amp;rdquo; likely refers to fraud against China&amp;rsquo;s state-run medical insurance program, which has been the subject of increasingly intense enforcement actions by Chinese regulators.[[N:For further analysis of enforcement actions targeting medical insurance fraud in 2026, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-life-sciences-spring-2026" target="_self"&gt;China Compliance Update: Life Sciences &amp;mdash; Spring 2026&lt;/a&gt;.]] If regulators find evidence of commercial bribery, fraud, or other illegal activity, they may not only publish their findings of misconduct on the Platform, but also require the MAH to publicly disclose the misconduct on the MAH&amp;rsquo;s own website. MAHs may also face additional penalties, including public disclosure of findings of noncompliant conduct, targeting for enhanced regulatory scrutiny, and debarment from public procurement programs.&lt;/p&gt;
&lt;h2&gt;Takeaways&lt;/h2&gt;
&lt;p&gt;Chinese regulators remain focused on anti-corruption in the life sciences industry. The Management Measures provide a number of new regulatory requirements which pharmaceutical companies may wish to consider when reviewing their compliance programs:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Promotional Activities&lt;/strong&gt;. Review internal controls around the approval and monitoring of promotional activities, particularly for activities taking place at healthcare institutions.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Hiring and Employment&lt;/strong&gt;. Ensure that hiring processes for medical representatives comply with the Management Measures, including background checks for evidence of commercial bribery and having medical representatives sign compliance commitment letters.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Third Parties&lt;/strong&gt;: Implement appropriate due diligence, contracting, and monitoring processes for third-party promotional services organizations.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Training and Documentation&lt;/strong&gt;: Conduct regular compliance training for medical representatives and maintain appropriate books and records systems.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold &amp;amp; Porter&amp;rsquo;s &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/life-sciences-and-healthcare-regulatory" target="_self"&gt;Life Sciences&lt;/a&gt; or &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/white-collar-defense-and-investigations" target="_self"&gt;White Collar Defense &amp;amp; Investigations&lt;/a&gt; practice group.&lt;/p&gt;
&lt;p&gt;* Zhewen Zhang contributed to this Advisory.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C6149045-93AE-4D50-B4B8-60BAB396AE76}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/good-technology-gone-bad-when-innovation-meets-liability</link><a10:author><a10:name>Lori B. Leskin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/leskin-lori-b</a10:uri><a10:email>lori.leskin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>E. Dean H. Porter</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/porter-dean</a10:uri><a10:email>dean.porter@arnoldporter.com</a10:email></a10:author><title>Good Technology Gone Bad: When Innovation Meets Liability</title><description>Please join Arnold &amp;amp; Porter&amp;rsquo;s Technology &amp;amp; Media industry group for a webinar exploring the legal, regulatory, and reputational risks that can emerge when innovative consumer technologies are allegedly misused</description><pubDate>Wed, 17 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Please join Arnold &amp;amp; Porter&amp;rsquo;s Technology &amp;amp; Media industry group for a webinar exploring the legal, regulatory, and reputational risks that can emerge when innovative consumer technologies are allegedly misused in ways their creators never intended.&lt;/p&gt;
&lt;p&gt;Our panel will examine:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;How product features involving recording, tracking, connected devices, and data sharing can become the subject of litigation and public scrutiny when they intersect with privacy, safety, and law enforcement concerns&lt;/li&gt;
    &lt;li&gt;Emerging theories of liability and key risk areas in product design and deployment&lt;/li&gt;
    &lt;li&gt;Practical steps companies can take to strengthen governance, anticipate misuse scenarios, and better position themselves before disputes arise&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{C6B4218F-1877-49C2-83F2-65994226B134}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/the-eu-anti-corruption-directive-raises-compliance-standard-for-businesses</link><a10:author><a10:name>Kathleen Harris</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/harris-kathleen</a10:uri><a10:email>kathleen.harris@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sean Curran</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/curran-sean</a10:uri><a10:email>sean.curran@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Melissa Dames</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dames-melissa</a10:uri><a10:email>melissa.dames@arnoldporter.com</a10:email></a10:author><title>The EU Anti-Corruption Directive Raises Compliance Standard for Businesses</title><description>The EU Anti-Corruption Directive, which entered into force on May 31, 2026, creates a harmonized anti-corruption framework across the EU by standardizing corruption offenses, expanding corporate liability, and introducing significant penalties, including fines tied to a company&amp;rsquo;s global turnover. The directive applies broadly to businesses with EU operations, including non-EU companies, and introduces a new &amp;ldquo;trading in influence&amp;rdquo; offense that heightens compliance risks for organizations engaging lobbyists, consultants, or intermediaries. It also incentivizes robust compliance programs, voluntary disclosure, and cooperation with authorities, while signaling a more coordinated and aggressive enforcement environment across EU Member States.&amp;nbsp;</description><pubDate>Wed, 17 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On May 31, 2026, &lt;a rel="noopener noreferrer" href="https://eur-lex.europa.eu/eli/dir/2026/1021/oj/eng" target="_blank"&gt;Directive (EU) 2026/1021&lt;/a&gt; of the European Parliament and of the Council of April 29, 2026 on combatting corruption (the EU Anti-Corruption Directive) entered into force, marking a significant step towards establishing a stronger EU legislative framework for combatting corruption effectively, with more harmonized national enforcement standards throughout the EU Member States.&lt;/p&gt;
&lt;p&gt;The EU Anti-Corruption Directive harmonizes corruption offenses across the EU, introduces a new standalone &amp;ldquo;trading in influence&amp;rdquo; offense, and raises the stakes for individuals and businesses alike through turnover-based penalties. Genuine compliance programs, cooperation with authorities, and voluntary disclosure are all expressly recognized as mitigating factors, giving businesses a real incentive to reduce their risk exposure before Member States pass their implementing legislation.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;Corruption remains a significant and costly challenge across the EU. Between 2016 and 2021, the total cost of corruption risk in public procurement across all sectors in the EU was estimated at &amp;euro;29.6 billion. More recently, in 2025, 69% of Europeans considered corruption to be widespread in their country, with 66% believing that high-level corruption cases are not pursued sufficiently.&lt;/p&gt;
&lt;p&gt;In view of this, the Commission presented an Anti-Corruption Package in May 2023, including a proposal to combat corruption by criminal law. Negotiations were difficult, and a provisional agreement between the Commission, the Parliament, and the Council was not reached until December 2025. The European Parliament formally adopted the text in March 2026 by 581 votes to 21, with the Council giving its final approval on April 21, 2026.&lt;/p&gt;
&lt;p&gt;The EU Anti-Corruption Directive forms a core part of that broader package, introducing harmonized criminal offenses, minimum standards for penalties, and a turnover-based sanctioning regime applicable across the public and private sectors. It consolidates and substantially replaces the existing EU anti-corruption framework, including the 1997 Convention on corruption involving EU officials and Council Framework Decision 2003/568/JHA on combating corruption in the private sector, which had proved too high-level and directional to keep pace with increasingly sophisticated cross-border corruption, resulting in significant divergence in enforcement standards across Member States. The EU Anti-Corruption Directive seeks to address this by establishing a single, harmonized framework of criminal offenses and penalties applicable across both the public and private sectors. It will be complemented by a forthcoming EU Anti-Corruption Strategy expected later in 2026, which is anticipated to set out the broader political and institutional framework within which the EU Anti-Corruption Directive will operate.&lt;/p&gt;
&lt;h2&gt;Scope&lt;/h2&gt;
&lt;p&gt;The EU Anti-Corruption Directive applies to any business in the public or private sector with operations, subsidiaries, or business activities within the EU, bringing companies that are headquartered in the UK and the U.S. within scope. The definition of a &amp;ldquo;public official&amp;rdquo; is broad, extending beyond formal officeholders to include any person exercising a public service function, including employees of privately owned companies that perform public services.&lt;/p&gt;
&lt;h2&gt;Transposition&lt;/h2&gt;
&lt;p&gt;Member States will be expected to transpose the new provisions into national law within 24 months, although obligations relating to risk assessment and national anti-corruption strategies will have a longer transposition period of up to 36 months. National implementing legislation will be carefully watched, as part of the purpose of this Directive is to harmonize the EU-wide approach to corruption.&lt;/p&gt;
&lt;p&gt;Member States will retain their own investigatory bodies and competent authorities operating within their national legal systems. Each Member State also retains autonomy over how it structures its investigatory and prosecutorial functions. However, the EU Anti-Corruption Directive emphasizes cross-border cooperation designed to address one of the most significant weaknesses in the previous framework.&lt;/p&gt;
&lt;h2&gt;What Are the Key Offenses?&lt;/h2&gt;
&lt;p&gt;The EU Anti-Corruption Directive standardizes a set of criminal offenses across all Member States, applicable when the conduct was intentional and committed either directly or indirectly.&lt;/p&gt;
&lt;p&gt;The key offenses are:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Bribery in the public sector (Article 3)&lt;br /&gt;
    Active bribery, comprising a promise, offer, or giving of an undue advantage to a public official, either directly or indirectly through an intermediary, is criminalized. Passive bribery, comprising a request or receipt of an undue advantage by a public official, either directly or indirectly through an intermediary, is also criminalized. The definition of &amp;ldquo;undue advantage&amp;rdquo; is broad and can be tangible or intangible, pecuniary or non-pecuniary, although gifts of low value are excluded.&lt;/li&gt;
    &lt;li&gt;Bribery in the private sector (Article 4)&lt;br /&gt;
    Active and passive bribery in the course of business is criminalized where a person directing or working for a private sector entity acts (or refrains from acting) in breach of their duties, in exchange for an undue advantage. A &amp;ldquo;breach of duty&amp;rdquo; covers, at a minimum, any behavior constituting a breach of a statutory duty, professional regulations, or instructions applicable within the entity.&lt;/li&gt;
    &lt;li&gt;Trading in influence (Article 6)&lt;br /&gt;
    Perhaps the most significant new offense for businesses, and one with no direct equivalent in many existing national regimes, it criminalizes the promising, offering, or giving of an undue advantage, including through an intermediary, to exert improper influence over a public official, regardless of whether the influence was real, actually exerted, or effective in changing behavior. The request or receipt is also criminalized. While legitimate interest representation that does not result in an &amp;ldquo;undue advantage&amp;rdquo; is carved out, Member States will need to carefully consider the line between lawful lobbying and criminal conduct. Businesses that engage lobbyists, government affairs consultants, or former public officials to interact with regulators or public authorities on their behalf face a new compliance risk under this offense.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Other criminal offenses include misappropriation (Article 5), unlawful exercise of public functions (Article 7), obstruction of justice (Article 8), enrichment from corruption offenses (Article 9), and incitement, aiding and abetting, and attempt (Article 11).&lt;/p&gt;
&lt;h2&gt;Corporate Liability&lt;/h2&gt;
&lt;p&gt;The EU Anti-Corruption Directive imposes criminal liability on a legal person where an offense is committed for its benefit by a person in a &amp;ldquo;leading position&amp;rdquo; within the organization (Article 13). A &amp;ldquo;leading person&amp;rdquo; is broadly defined to include one or more of the following:&lt;/p&gt;
&lt;ol style="margin-left: 40px;"&gt;
    &lt;li&gt;A power of representation of the legal person&lt;/li&gt;
    &lt;li&gt;An authority to take decisions on behalf of the legal person&lt;/li&gt;
    &lt;li&gt;An authority to exercise control within the legal person&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;While in practice this is likely to include directors, senior executives and other individuals at management level, the precise boundaries are likely to be the subject of further debate, particularly as the Member States transpose the EU Anti-Corruption Directive into national law.&lt;/p&gt;
&lt;p&gt;Importantly, Article 13(2) imposes liability on a legal person where the lack of supervision or control made possible the criminal offense, where that offense was committed for the entity&amp;rsquo;s benefit. Liability incurred from failure to supervise has significant implications for how businesses structure their compliance frameworks, particularly in relation to junior employees, agents, and others acting on the company&amp;rsquo;s behalf.&lt;/p&gt;
&lt;p&gt;Corporate liability under the EU Anti-Corruption Directive does not replace individual liability, and businesses should be prepared for the possibility of simultaneous investigations and prosecutions on both the corporate and individual levels.&lt;/p&gt;
&lt;h2&gt;Penalties and Sentencing&lt;/h2&gt;
&lt;p&gt;The EU Anti-Corruption Directive sets minimum standards for both custodial sentences and financial penalties, and introduces a turnover-based sanctioning regime for legal persons that raises the stakes for corporate non-compliance across the EU.&lt;/p&gt;
&lt;p&gt;Member States must ensure that the offenses under the EU Anti-Corruption Directive are punishable by maximum terms of imprisonment of at least five years for public sector bribery and at least three years for private sector bribery (Article 12). These are minimum terms, and Member States may provide for higher maximum sentences under their national implementing legislation.&lt;/p&gt;
&lt;p&gt;For legal persons, the EU Anti-Corruption Directive introduces two alternative bases for financial penalties. Member States must provide either for turnover-based fines of at least 5% of worldwide annual turnover for the core bribery offenses and misappropriation (and at least 3% for certain other offenses, including trading in influence, obstruction, and enrichment), or for fixed fines of at least &amp;euro;40 million and &amp;euro;24 million respectively (Article 14). Turnover-based fines can be significant for large multinationals, with 5% of worldwide annual turnover exceeding any fixed penalty and creating a clear incentive for businesses to revisit how they address regulatory risk.&lt;/p&gt;
&lt;p&gt;Beyond financial penalties and imprisonment, the EU Anti-Corruption Directive provides for a range of additional sanctions and measures that can be imposed on individuals and legal persons, including disqualification from carrying on business activities, exclusion from access to public funding and tender procedures, and publication of the judicial decision. For businesses that depend on public sector contracts or EU funding, the reputational and commercial consequences should not be underestimated.&lt;/p&gt;
&lt;h2&gt;Aggravating and Mitigating Circumstances&lt;/h2&gt;
&lt;p&gt;The EU Anti-Corruption Directive specifies a number of aggravating and mitigating factors. For example, Member States may treat repeat offending, the obtaining of substantial benefit or causing of substantial damage, and the offender being an AML-obliged entity or a person in a leading position at one, as aggravating factors (Article 15). Voluntary disclosure and remedial action taken upon discovery, cooperation with competent authorities, and the legal person having implemented effective internal controls, ethics awareness, and compliance programs are all mitigating factors (Article 16). Compliance programs must be genuine and effective to qualify as a mitigating factor; they risk being treated as an aggravating one.&lt;/p&gt;
&lt;h2&gt;Practical Implications for Businesses&lt;/h2&gt;
&lt;p&gt;Businesses with EU operations should treat the EU Anti-Corruption Directive as a prompt to audit and strengthen their existing anti-bribery and corruption frameworks to ensure they are capable of withstanding scrutiny. Compliance programs must be genuinely effective since their presence is a formal mitigating factor at sentencing, whereas superficial or &amp;ldquo;window dressing&amp;rdquo; programs risk being treated as aggravating ones.&lt;/p&gt;
&lt;p&gt;Particular attention should be given to the trading-in-influence offense, which is novel in many jurisdictions and has direct implications for how businesses select, due diligence, and instruct lobbyists, government affairs consultants, and other intermediaries who interact with public officials on their behalf.&lt;/p&gt;
&lt;p&gt;Businesses should also map which individuals across their management structures and group entities fall within the &amp;ldquo;leading position&amp;rdquo; corporate liability trigger, and ensure that compliance oversight and escalation mechanisms operate effectively across all entities. Whistleblowing channels should be reviewed to ensure corruption offenses are explicitly covered.&lt;/p&gt;
&lt;p&gt;The consequences of a successful prosecution are substantial and sit within a broader trend of increasingly aggressive enforcement across the EU. Regulators not only have greater ability and clearer mandates to pursue cases that would have previously fallen into jurisdictional gaps, but a combination of expanded offenses, wide jurisdictional reach, and penalties means businesses cannot treat anti-corruption compliance as a formality.&lt;/p&gt;
&lt;p&gt;* Sophia Kim contributed to this Advisory. Sophia is employed as a&amp;nbsp;Trainee Solicitor in Arnold &amp;amp; Porter&amp;rsquo;s London office.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{6D3F0641-C6D5-4882-9131-57D64FF6841A}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/supreme-court-shuts-the-door-on-ica-rescission-claims</link><a10:author><a10:name>Bou Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-bou</a10:uri><a10:email>bou.lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Arthur Luk</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/luk-arthur</a10:uri><a10:email>Arthur.Luk@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Aaron F. Miner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/miner-aaron-f</a10:uri><a10:email>aaron.miner@arnoldporter.com</a10:email></a10:author><title>Supreme Court Shuts the Door on ICA Rescission Claims: What Closed-End Fund Managers Need to Know</title><description>In &lt;em data-start="3" data-end="62"&gt;FS Credit Opportunities Corp. v. Saba Capital Master Fund&lt;/em&gt;, the U.S. Supreme Court held that Section 47(b) of the Investment Company Act does not create an implied private right of action for investors seeking rescission of contracts that allegedly violate the Act. The decision reinforces that enforcement of most ICA provisions remains primarily with the SEC and limits shareholders&amp;rsquo; ability to challenge fund governance practices through federal litigation.</description><pubDate>Wed, 17 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On June 11, 2025, the U.S. Supreme Court decided &lt;em&gt;FS Credit Opportunities Corp., et al. v. Saba Capital Master Fund, Ltd., et al.&lt;/em&gt; (24-345), &lt;a rel="noopener noreferrer" href="https://www.supremecourt.gov/opinions/25pdf/24-345_i42k.pdf" target="_blank"&gt;holding&lt;/a&gt; that Section 47(b) of the Investment Company Act of 1940 (ICA) does not create an implied right of action for rescission.&lt;/p&gt;
&lt;p&gt;Typically enforced by the Securities and Exchange Commission (SEC), the ICA governs mutual funds and other registered investment companies. With two exceptions, no section of the ICA expressly authorizes a private right of action. The question presented was whether private parties have an implied right of action under Section 47(b) to sue for rescission of contracts that allegedly violate the ICA. In line with its recent reluctance to find implied private rights of action, a six-justice majority of the Court held the answer is &amp;ldquo;no.&amp;rdquo;&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;In 2023, activist investor Saba Capital (Saba) sued several closed-end mutual funds (the Funds) that had adopted &amp;ldquo;control share provisions&amp;rdquo; under Maryland law that diluted investors&amp;rsquo; voting shares. Saba alleged that depriving shareholders of their voting rights violated Section 18(i) of the ICA.[[N:Section 18(i) requires that &amp;ldquo;every share of stock hereafter issued by a registered management company &amp;hellip; shall be a voting stock and have equal voting rights with every other outstanding voting stock.&amp;rdquo; 15 U.S.C. &amp;sect; 80a-18(i).]] Arguing that the control share provisions also affect the Funds&amp;rsquo; and shareholders&amp;rsquo; contractual relationship, Saba sought rescission pursuant to Section 47(b) of the ICA, which provides that contracts that violate the ICA are &amp;ldquo;unenforceable by either party.&amp;rdquo; 15 U.S.C. &amp;sect; 80a-46(b)(1). Saba argued Section 47(b) also provides a right of action via the provision that &amp;ldquo;a court may not deny rescission at the instance of any party&amp;rdquo; absent certain findings.&lt;/p&gt;
&lt;p&gt;Saba&amp;rsquo;s arguments relied heavily on the 1979 Supreme Court decision in &lt;em&gt;Transamerica Mortgage Advisors, Inc. v. Lewis&lt;/em&gt;, 444 U.S. 11 (1979) (&lt;em&gt;TAMA&lt;/em&gt;), which held there was an implied private right of action for rescission in a parallel provision of a related statute, the Investment Advisers Act of 1940 (IAA). Section 215(b) of the IAA provides that contracts that violate the statute &amp;ldquo;shall be void,&amp;rdquo; thereby authorizing rescission of such contracts. 15 U.S. Code &amp;sect; 80b-15(b). Saba pointed to both statutes&amp;rsquo; legislative history, as they were enacted together. After &lt;em&gt;TAMA&lt;/em&gt;, Congress amended 47(b) of the ICA to include that a court &amp;ldquo;may not deny rescission at the instance of &lt;em&gt;any party&lt;/em&gt;&amp;rdquo; absent certain findings.[[N:A court may not deny rescission unless it finds that doing so would be more equitable and would not be inconsistent with the ICA&amp;rsquo;s purpose. 15 U.S. Code &amp;sect; 80a-46(b)(2).]] 15 U.S. Code &amp;sect; 80a-46(b)(2) (emphasis added). Saba argued this language provides a limited private right to seek rescission of a contract that violates the ICA.[[N:Brief for Respondents, &lt;em&gt;FS Credit Opportunities Corp., et al, Petitioners v. Saba Capital Master Fund, Ltd., et al.&lt;/em&gt; (2025) (No. 24-345), at 1-3.]]&lt;/p&gt;
&lt;h2&gt;Opinion&lt;/h2&gt;
&lt;p&gt;Writing for the majority, Justice Amy Coney Barrett held that Section 47(b)&amp;rsquo;s phrase &amp;ldquo;rescission at the instance of any party&amp;rdquo; does not imply that private parties may sue. (Op. 5). Chief Justice John Roberts and Justices Clarence Thomas, Samuel Alito, Neil Gorsuch, and Brett Kavanaugh joined the majority.&lt;/p&gt;
&lt;p&gt;The majority explained that Section 47(b)&amp;rsquo;s provision is a &amp;ldquo;mandate directed to &amp;hellip; courts&amp;rdquo; and does not confer a right to individuals. Id. (citation omitted). &amp;ldquo;Section 47(b)&amp;rsquo;s wording thus presupposes that parties are already before the court and directs the court&amp;rsquo;s use of its remedial authority.&amp;rdquo; Id. The majority emphasized that under contract law, rescission is a remedy rather than a cause of action. Citing the statutory structure, the majority also noted that the SEC is the ICA&amp;rsquo;s main enforcer and that the act already expressly authorizes two private rights of action for other sections of the ICA: (1) for shareholders to sue investment advisors for certain breaches of fiduciary duty (15 U.S. Code &amp;sect; 80a-35(b)), and (2) for securities holders to sue certain insider defendants to recover short-swing profits (15 U.S. Code &amp;sect; 80a-29(h)). Thus, &amp;ldquo;nothing in the text or structure of the ICA indicates that Congress authorized private parties to enforce virtually every provision in the statute.&amp;rdquo; (Op. 8).&lt;/p&gt;
&lt;p&gt;The majority also rejected Saba&amp;rsquo;s reliance on &lt;em&gt;TAMA&lt;/em&gt; and statutory history, finding that Congress&amp;rsquo; amendments distinguish Section 47(b) from Section 215 of the IAA. The most significant change according to the majority was Congress&amp;rsquo; deletion of the phrase &amp;ldquo;shall be void&amp;rdquo; from Section 47(b), which is the language on which &lt;em&gt;TAMA&lt;/em&gt; turns and which remains in Section 215. Accordingly, the majority found that Congress&amp;rsquo; amendments &amp;ldquo;were a renovation, not a new coat of paint.&amp;rdquo; (Op. 10).&lt;/p&gt;
&lt;p&gt;Justice Ketanji Brown Jackson, joined by Justice Sonia Sotomayor in full and Justice Elena Kagan in part, dissented. In her view, Congress&amp;rsquo; post-&lt;em&gt;TAMA&lt;/em&gt; amendments to Section 47(b) ratified &lt;em&gt;TAMA&lt;/em&gt;&amp;rsquo;s holding, rather than changed it. (Dissent 7-10). She pointed to House and Senate Committee Reports for the post-&lt;em&gt;TAMA&lt;/em&gt; amendments that explicitly stated private rights of action should be implied under the amended statute &amp;ldquo;to the same extent&amp;rdquo; as before. (Dissent 12).&lt;/p&gt;
&lt;p&gt;Justice Kagan wrote separately, explaining that she believed that Section 47(b)&amp;rsquo;s text is sufficiently clear such that there is no need to rely on legislative history to interpret the statute.&lt;/p&gt;
&lt;h2&gt;Impact on Investors&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Even more state court actions?&lt;/strong&gt; The decision is a setback for activist investors like Saba that are now foreclosed from suing for contract rescission under the ICA. Prior to this decision, activist investors had some success bringing ICA rescission cases before the Second Circuit. The decision may shift litigation to state court, as activists may now look even more to state law claims like breach of fiduciary duty claims or proxy fights to challenge governance structures. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Funds are better insulated&lt;/strong&gt;. Relatedly, while the decision did not address the legality of the Funds&amp;rsquo; actions, it nevertheless gives funds one less federal challenge to worry about when opting into state control share statutes to resist activist pressure. Without the threat of an ICA lawsuit, some closed-end funds may feel more confident using state incorporation law as a shield against activist investors like Saba. More broadly speaking, there is one less mechanism available to shareholders to hold closed-end funds, especially underperforming ones, accountable. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Less enforcement of the ICA?&lt;/strong&gt; In her dissent, Justice Jackson cited House and Senate Committee Reports that stated private actions could fill the enforcement gap created by the SEC&amp;rsquo;s relatively small staff. (Dissent 12). The Court&amp;rsquo;s ruling limits shareholders&amp;rsquo; avenues for challenging alleged violations of the ICA and places the onus back on the SEC, which has recently brought significantly fewer enforcement actions generally.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;If you have questions about this Advisory, please contact your Arnold &amp;amp; Porter relationship attorney or the authors of this Advisory.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{043BAB09-5D90-4026-85B9-67B384011497}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/part-i-biotech-deals-creating-optimal-licensing-and-partnering-arrangements</link><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abigail Struthers</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/struthers-abigail</a10:uri><a10:email>abigail.struthers@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Matthew Tabas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabas-matthew</a10:uri><a10:email>matthew.tabas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kristin M. Hicks</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hicks-kristin-m</a10:uri><a10:email>kristin.hicks@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alana Reid</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/reid-alana-j</a10:uri><a10:email>alana.reid@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Michael Penney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/penney-michael</a10:uri><a10:email>michael.penney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Hemmie Chang</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chang-hemmie</a10:uri><a10:email>hemmie.chang@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alyssa S. Hogan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hogan-alyssa-s</a10:uri><a10:email>alyssa.hogan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eric Rothman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rothman-eric</a10:uri><a10:email>eric.rothman@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Betty Yan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/y/yan-betty</a10:uri><a10:email>betty.yan@arnoldporter.com</a10:email></a10:author><title>Part I: Biotech Deals — Creating Optimal Licensing and Partnering Arrangements</title><description>Please join Arnold &amp;amp; Porter for Part I of our in-person series designed for legal and business leaders at biotechnology companies focused on optimizing their licensing and partnering.</description><pubDate>Tue, 16 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Please join Arnold &amp;amp; Porter for Part I of our in-person series designed for legal and business leaders at biotechnology companies focused on optimizing their licensing and partnering.&lt;/p&gt;
&lt;p&gt;This program will take the form of a presentation and boardroom-style discussion focused on the strategic question of whether to license an asset. We will explore key considerations that inform licensing and partnering strategies, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Out-licensing versus strategic alternatives&lt;/li&gt;
    &lt;li&gt;Transaction structuring priorities, including diligence focus&lt;/li&gt;
    &lt;li&gt;Intellectual property and exclusivity protections&lt;/li&gt;
    &lt;li&gt;Regulatory pathways considerations&lt;/li&gt;
    &lt;li&gt;Antitrust and Hart-Scott-Rodino Act compliance issues&lt;/li&gt;
    &lt;li&gt;Tariff and pricing dynamics (including IRA and MFN considerations)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;We look forward to a thoughtful and engaging discussion!&lt;/p&gt;
&lt;h3&gt;Program Alert&lt;/h3&gt;
&lt;p&gt;We hope you&amp;rsquo;ll save &lt;strong&gt;Wednesday, September 16&lt;/strong&gt; for the second program in this series where we&amp;rsquo;ll explore practical approaches to navigating and resolving complex disputes that may arise when a licensing partnership begins to unravel.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8B8ADB1F-48C6-498D-93E2-86AB7975A3FF}</guid><link>https://www.acc.com/education-events/2026/its-doge-new-world-navigating-environmental-enforcement-landscape-webinar</link><author>benjamin.piper@arnoldporter.com</author><title>It's a DOGE New World: Navigating the Environmental Enforcement Landscape Webinar</title><pubDate>Tue, 16 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{EB3C4439-5A77-4322-ABA4-51073631CDB4}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/national-security-controls-and-the-life-sciences-sector</link><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mahnu V. Davar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/davar-mahnu-v</a10:uri><a10:email>mahnu.davar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bobby McMillin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mcmillin-bobby</a10:uri><a10:email>bobby.mcmillin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Betty Yan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/y/yan-betty</a10:uri><a10:email>betty.yan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Matthew Tabas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabas-matthew</a10:uri><a10:email>matthew.tabas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katherine Rohde</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rohde-katherine</a10:uri><a10:email>kate.rohde@arnoldporter.com</a10:email></a10:author><title>National Security Controls and the Life Sciences Sector: BIOSECURE Act, Section 1260H, and COINS Act Developments</title><description>Following the U.S. Department of Defense&amp;rsquo;s addition of WuXi AppTec and other biotech companies to its list of Chinese military companies, these entities may soon face restrictions under the BIOSECURE Act, while lawmakers are also pushing to subject biotechnology investments and licensing deals with Chinese firms to outbound investment controls under the COINS Act and proposed BINSA legislation. Companies in the pharmaceutical and biotechnology sectors should closely monitor these developments, assess existing partnerships, and prepare for potential compliance and supply chain impacts.</description><pubDate>Tue, 16 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;h2&gt;Executive Summary&lt;/h2&gt;
&lt;p&gt;The life sciences sector continues to be a growing area of interest for national security controls, as U.S. pharmaceutical companies have increasingly partnered with Chinese firms for development, manufacturing, and licensing arrangements. On June 8, 2026, the U.S. Department of Defense (DoD) added WuXi AppTec &amp;mdash; a prominent Chinese drug development and manufacturing services provider &amp;mdash; to its list of &amp;ldquo;Chinese military companies&amp;rdquo; operating in the United States. The listing sets the stage for WuXi AppTec and other Chinese entities to be designated as a &amp;ldquo;biotechnology company of concern&amp;rdquo; under the BIOSECURE Act, which may restrict pharmaceutical companies&amp;rsquo; ability to use their biotechnology equipment and services in connection with certain federal contracts. WuXi AppTec has already filed a legal challenge to its designation as a Chinese military company, and other companies may follow suit. Elsewhere, a growing number of lawmakers are calling for biotechnology transactions and licensing arrangements with Chinese firms to be subject to outbound investment screening requirements, as codified under the Comprehensive Outbound Investment National Security (COINS) Act. As the regulatory landscape continues to shift, industry participants should carefully evaluate the impact on their current and future arrangements with Chinese life sciences companies.&lt;/p&gt;
&lt;h2&gt;BIOSECURE Act and the 1260H List&lt;/h2&gt;
&lt;p&gt;On June 8, 2026, the DoD issued an &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fmedia.defense.gov%2F2026%2FJun%2F08%2F2003945537%2F-1%2F-1%2F1%2FENTITIES-IDENTIFIED-AS-CHINESE-MILITARY-COMPANIES-OPERATING-IN-THE-UNITED-STATES-IN-ACCORDANCE-WITH-SECTION-1260H.PDF&amp;amp;data=05%7C02%7CTheresa.Denson%40arnoldporter.com%7Ca2b2625e540b4fefd15e08decb1c5311%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639171519685511520%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=hpz3NVp9Dw8Id2yF6ipvb5urwM75HBXVmxQVWmSBA6A%3D&amp;amp;reserved=0" target="_blank"&gt;updated version&lt;/a&gt; of its list of Chinese military companies operating in the United States, known as the &amp;ldquo;1260H List.&amp;rdquo; Notably, the new list includes WuXi AppTec Co., Ltd., which DoD described as &amp;ldquo;indirectly owned by&amp;rdquo; the State-owned Assets Supervision and Administration Commission (SASAC) and &amp;ldquo;indirectly affiliated with&amp;rdquo; the People&amp;rsquo;s Liberation Army (PLA) and the State Administration of Science, Technology and Industry for National Defense (SASTIND). The list also includes BGI Group (with seven listed affiliates), MGI Tech Co., Ltd., Novogene Company Limited, and Origincell Technology Co., Ltd., as well as companies involved in digital health and related sectors such as Alibaba Group Holding Limited and Tencent Holdings Limited.&lt;/p&gt;
&lt;p&gt;The 1260H listing is significant because it lays the groundwork for WuXi AppTec and other listed entities to be designated as potential &amp;ldquo;biotechnology companies of concern&amp;rdquo; (BCCs) under the BIOSECURE Act, enacted as part of the FY26 National Defense Authorization Act (NDAA). As explained in our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/12/the-biosecure-act-becomes-law-in-the-united-states" target="_self"&gt;December 2025 Advisory&lt;/a&gt;, the BIOSECURE Act prohibits federal agencies from entering into, extending, or renewing any &amp;ldquo;contract&amp;rdquo; with an entity that uses &amp;ldquo;biotechnology equipment or services&amp;rdquo; from a BCC in performance of that contract. It also prohibits using federal loan or grant funds to procure or use biotechnology equipment or services from a BCC. Accordingly, pharmaceutical manufacturers may soon face restrictions on the use of certain equipment and services from WuXi AppTec or other listed entities in connection with their federal contracts and grants. &lt;/p&gt;
&lt;p&gt;A company may qualify as a BCC if it is (1) included on the 1260H List and (2) &amp;ldquo;involved in the manufacturing, distribution, provision, or procurement&amp;rdquo; of a biotechnology equipment or service. Whether a company satisfies the second prong is determined through an administrative process involving the Office of Management and Budget (OMB), DoD, and other executive agencies.&lt;/p&gt;
&lt;p&gt;Now that WuXi AppTec and others have been identified in the 1260H List, the U.S. government will determine if the listed companies have the required nexus to biotechnology equipment or services. If so, these companies will be included in the initial list of BCCs published by OMB, which must be issued by December 18, 2026. To the extent the U.S. government determines any subsidiary of a listed company also qualifies as a BCC, those subsidiaries would likewise be identified in the initial BCC list. The U.S. government may designate a company that is not on the 1260H List as a BCC, if it determines the company is controlled by the government of a foreign adversary and poses a national security risk.&lt;/p&gt;
&lt;p&gt;Importantly, the BIOSECURE Act&amp;rsquo;s prohibitions do not take immediate effect upon an entity&amp;rsquo;s designation as a BCC. Companies that have existing arrangements with BCCs can also take advantage of the statute&amp;rsquo;s five-year grandfathering period for biotechnology equipment or services provided under contracts executed before the statute&amp;rsquo;s prohibitions take effect.&lt;/p&gt;
&lt;p&gt;
&lt;p&gt;As previously noted, WuXi AppTec has filed a legal challenge to its addition to the 1260H List, and other newly listed companies may follow suit. In 2021, consumer goods manufacturer Xiaomi Corp successfully litigated the removal of its designation as a &amp;ldquo;Communist Chinese military company&amp;rdquo; under Executive Order 13595. Litigation and lobbying efforts by these companies may further complicate or extend the timeline.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;Pharmaceutical companies with potentially implicated arrangements can take time now to evaluate the extent to which those arrangements involve &amp;ldquo;biotechnology equipment or services&amp;rdquo; used &amp;ldquo;in performance of&amp;rdquo; their federal contracts. Companies may also wish to review existing contracts to ensure they are positioned to take advantage of the BIOSECURE Act&amp;rsquo;s grandfathering provision, or consider negotiating a transition plan away from designated entities to avoid the application of the BIOSECURE Act.&lt;/p&gt;
&lt;p&gt;
&lt;p&gt;Companies should also consider reviewing their relationships with Chinese companies added to the 1260H list holistically, whether or not the Chinese companies are ultimately designated as BCCs, to consider potential impact on cooperation in digital health, enterprise technology, and other sectors.&lt;/p&gt;
&lt;/p&gt;
&lt;h2&gt;Outbound Investment Rules and Biotechnology&lt;/h2&gt;
&lt;p&gt;Cross-border licensing deals between Chinese biotechnology companies and global pharmaceutical firms have &lt;a rel="noopener noreferrer" href="https://www.reuters.com/sustainability/climate-energy/china-biotech-licensing-boom-hit-record-2026-pipeline-swells-2026-02-13/" target="_blank"&gt;surged&lt;/a&gt; in recent years, reaching a record $137 billion in total deal value in 2025 &amp;mdash; a nearly tenfold increase from $13.9 billion in 2021. As U.S. pharmaceutical companies have increasingly pursued these development and licensing arrangements with Chinese firms, a growing number of lawmakers have called for the transactions to be subject to outbound investment controls. Much of the discussion has focused on the COINS Act, also enacted as part of the FY26 NDAA alongside the BIOSECURE Act. &lt;/p&gt;
&lt;p&gt;The COINS Act codifies and broadens the existing Outbound Investment Security Program established under 31 C.F.R. Part 850. Generally, the COINS Act authorizes the Secretary of the U.S. Department of the Treasury (Treasury Department) to prohibit or impose notification requirements for certain outbound &amp;ldquo;covered national security transactions&amp;rdquo; involving a &amp;ldquo;prohibited technology&amp;rdquo; or &amp;ldquo;notifiable technology.&amp;rdquo; The COINS Act defines &amp;ldquo;covered national security transaction&amp;rdquo; to include certain types of transactions with a connection to a &amp;ldquo;country of concern,&amp;rdquo; including China. &lt;/p&gt;
&lt;p&gt;The existing Outbound Investment Security Program remains in effect until the Treasury Department issues implementing regulations.&lt;/p&gt;
&lt;h3&gt;COINS Act Implementation&lt;/h3&gt;
&lt;p&gt;Biotechnology is not currently identified as a &amp;ldquo;prohibited technology&amp;rdquo; or &amp;ldquo;notifiable technology&amp;rdquo; under the COINS Act. However, the COINS Act authorizes the Treasury Department Secretary to add through regulations additional technology categories that &amp;ldquo;enable the military, intelligence, surveillance, or cyber-enabled capabilities of a country of concern.&amp;rdquo; Some lawmakers are now urging the Treasury Department to use this regulatory authority to address biotechnology transactions.&lt;/p&gt;
&lt;p&gt;In February 2026, several Republican lawmakers &lt;a rel="noopener noreferrer" href="https://chinaselectcommittee.house.gov/sites/evo-subsites/selectcommitteeontheccp.house.gov/files/evo-media-document/coins-implementation-letter-02.26.2026.pdf" target="_blank"&gt;sent a letter&lt;/a&gt; to Treasury Department Secretary Scott Bessent, urging the administration to expand the Outbound Investment Security Program to include biotechnology-related investments. The letter contends that continued U.S. investment in the Chinese biotechnology industry could leave the United States &amp;ldquo;dangerously dependent&amp;rdquo; on China for advanced medicines and threaten American leadership in biotechnology.&lt;/p&gt;
&lt;p&gt;Representative John Moolenaar (R-MI), Chair of the Select Committee on China, &lt;a rel="noopener noreferrer" href="https://files.constantcontact.com/f0eecb46901/6d9fa229-f025-471e-92d5-e1aa8bb62d4b.pdf" target="_blank"&gt;penned a separate letter&lt;/a&gt; to Secretary Bessent on May 21, 2026, again advocating that biotechnology transactions be subject to outbound investment screening. Moolenaar states that the rise of out-licensing and co-development arrangements between pharmaceutical companies and Chinese biotechnology firms risks &amp;ldquo;accelerating China&amp;rsquo;s dominance of the pharmaceutical innovation supply chain.&amp;rdquo; Moolenaar contends that the BIOSECURE Act &amp;ldquo;recognized that biotechnology is both a national security asset and a strategic vulnerability.&amp;rdquo; Failing to apply outbound investment rules to biotechnology transactions, Moolenaar argues, could create &amp;ldquo;long-term strategic dependency risks&amp;rdquo; for the United States, analogous to rare earth elements and parts of the semiconductor supply chain. Moolenaar requests that the Treasury Department give particular consideration to out-licensing arrangements involving pharmaceutical intellectual property, drug discovery platforms, clinical research and development capabilities, and biologics manufacturing and commercialization know-how.&lt;/p&gt;
&lt;h3&gt;Legislative Proposals&lt;/h3&gt;
&lt;p&gt;On June 2, 2026, Representatives Moolenaar and Debbie Dingell (D-MI) introduced the Biotech Investment National Security Act (BINSA). If enacted, BINSA would officially add &amp;ldquo;biotechnology&amp;rdquo; to the list of prohibited and notifiable technologies subject to outbound investment controls under the COINS Act. The bill adopts a broad definition of &amp;ldquo;biotechnology,&amp;rdquo; reaching the research, development, manufacturing, or commercialization of all &amp;ldquo;drugs&amp;rdquo; as defined in the Federal Food, Drug, and Cosmetic Act and all &amp;ldquo;biological products&amp;rdquo; as defined in the Public Health Service Act. It also covers &amp;ldquo;therapeutic compounds, including drug discovery platforms, clinical research and development capabilities, biologics manufacturing, and intellectual property and know-how relating to therapeutic compounds.&amp;rdquo; In practical terms, this definition could sweep in nearly the full spectrum of pharmaceutical activity involving Chinese firms, provided the transaction qualifies as a &amp;ldquo;covered national security transaction.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Importantly, BINSA would also add licensing arrangements to the list of covered transactions subject to outbound investment controls. Accordingly, if BINSA is enacted, pharmaceutical companies entering into licensing arrangements with Chinese firms could face notification requirements or outright prohibitions under the COINS Act. &lt;/p&gt;
&lt;p&gt;The most likely legislative vehicle for the BINSA&amp;rsquo;s potential enactment this year would be the FY27 NDAA. The FY26 NDAA included both BIOSECURE and the COINS Act. Notably, BIOSECURE received significant floor and committee consideration, over the course of nearly two years, before it was signed into law in December 2025.&lt;/p&gt;
&lt;p&gt;Although it is unclear whether BINSA has a path to enactment, it signifies a continued bipartisan focus on the national security implications of commercial relationships between U.S. pharmaceutical companies and Chinese firms. Even absent legislation, the Treasury Department Secretary retains authority under the COINS Act to expand outbound investment controls to biotechnology through rulemaking &amp;mdash; a possibility that industry participants should monitor closely.&lt;/p&gt;
&lt;h2&gt;Looking Ahead&lt;/h2&gt;
&lt;p&gt;The developments discussed in this Advisory reflect a broader trend toward extending national security controls to the life sciences sector. Industry participants should monitor developments, prepare contingency plans, and negotiate appropriate contractual protections for life sciences controls, including in the following:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;1260H List Designations&lt;/strong&gt;. Companies newly added to the 1260H list may contest their designation through lawsuits and negotiations with DoD. Even if companies on this list are not designated as BCCs, industry participants may wish to review their cooperation with these companies to assess potential impact on digital health, enterprise technology, and other initiatives.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;BIOSECURE Act implementation&lt;/strong&gt;. The release of OMB&amp;rsquo;s initial list of BCCs, due by December 18, 2026, will be a key milestone. Industry participants should also watch for required guidance and revisions to the Federal Acquisition Regulation that will shape how the statute&amp;rsquo;s prohibitions are applied in practice.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;COINS Act implementing regulations&lt;/strong&gt;. As the Treasury Department develops implementing regulations for the COINS Act, there is potential for biotechnology to be added as a prohibited or notifiable technology category &amp;mdash; even absent new legislation.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;BINSA and related legislation&lt;/strong&gt;. Although BINSA&amp;rsquo;s path to enactment is uncertain, it and similar legislative proposals signal sustained congressional interest in subjecting development and licensing arrangements with Chinese firms to outbound investment controls.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Congressional Consideration of FY27 NDAA&lt;/strong&gt;. While not technically in the Armed Services Committee&amp;rsquo;s jurisdiction, industry participants should monitor whether policies like BINSA, and similar legislative proposals, are discussed or offered as amendments.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Potential Countermeasures&lt;/strong&gt;. As the U.S. tightens its national security controls on biotechnology, China may pursue reciprocal measures that limit U.S. pharmaceutical companies&amp;rsquo; access to Chinese biotechnology assets. For example, Chinese regulators could add certain biotechnologies to its Catalogue of Technologies Prohibited and Restricted from Export, a regulatory tool governing technology transfer under the country&amp;rsquo;s export control laws. Chinese regulators may also consider subjecting biotech transactions to China&amp;rsquo;s own recently announced outbound investment regulations, which will take effect on July 1, 2026.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;We stand ready to advise our clients on the evolving national security landscape for the life sciences sector. If you have any questions about the content discussed in this Advisory or would like more information, please reach out to one of the authors or your existing Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9D81F62C-CB73-4975-903D-F03AAF3C771F}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/represents-wiley-in-acquisition-of-emerald-publishing-limited</link><title>Arnold &amp; Porter Represents Wiley in Acquisition of Emerald Publishing Limited </title><description>&lt;p&gt;Arnold &amp;amp; Porter recently advised &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnewsroom.wiley.com%2Fpress-releases%2Fpress-release-details%2F2026%2FWiley-Acquires-Emerald-Expanding-Research-Scale-and-Deepening-Proprietary-Content-Across-the-AI-Driven-Knowledge-Economy%2Fdefault.aspx&amp;amp;data=05%7C02%7CEmma.Ruberg%40arnoldporter.com%7C6ad673fac5e247fc25c208dec73780b3%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639167238342743862%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=FmJGnEBQ%2F5xeIb3tiwNb3D7j8A2cTEc%2FhzX71z2Z1HI%3D&amp;amp;reserved=0" target="_blank"&gt;Wiley&lt;/a&gt;, a content and research intelligence company, in its acquisition of Emerald Publishing Limited from Cambridge Information Group.&lt;/p&gt;</description><pubDate>Thu, 11 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnewsroom.wiley.com%2Fpress-releases%2Fpress-release-details%2F2026%2FWiley-Acquires-Emerald-Expanding-Research-Scale-and-Deepening-Proprietary-Content-Across-the-AI-Driven-Knowledge-Economy%2Fdefault.aspx&amp;amp;data=05%7C02%7CEmma.Ruberg%40arnoldporter.com%7C6ad673fac5e247fc25c208dec73780b3%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639167238342743862%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=FmJGnEBQ%2F5xeIb3tiwNb3D7j8A2cTEc%2FhzX71z2Z1HI%3D&amp;amp;reserved=0" target="_blank"&gt;Wiley&lt;/a&gt;, a content and research intelligence company, in its acquisition of Emerald Publishing Limited from Cambridge Information Group.&lt;/p&gt;
&lt;p&gt;The all-cash transaction, valued at &amp;pound;337 million (USD 452 million), expands Wiley&amp;rsquo;s portfolio to approximately 2,500 titles with the addition of Emerald&amp;rsquo;s portfolio.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by Private Equity Co-Head Lowell Dashefsky, U.S. Antitrust/Competition Chair C. Scott Lent, and partner James Attonito, and also included partners Benjamin Mintz and Matthew Tabas, senior associate Greg Criscitello, and associate Ally Krenos. Partners Jeremy Willcocks, Henry Clinton-Davis, and Beatriz San Martin, senior associate Shishu Chen, and associate Matty Desmond advised on U.K. matters, partner Laurie Abramowitz and senior associate Lauren Olaya advised on tax matters, partner Paul Llewellyn and senior associate Benjamin Danieli advised on intellectual property matters, partner Uri Horowitz and senior associate Kathryn Geoffroy advised on employee benefits and labor matters, and senior associate Leah Harrell and associate Thibault Henry advised on antitrust matters, among others.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{DB961963-F17A-48A6-B0F1-3DE233DDA8BD}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/law-times-korea-recognizes-arnold-and-porter-as-a-top-firm</link><title>Law Times Korea Names Arnold &amp; Porter Best Firm in 2026 Law Firm Consumer Report </title><description>&lt;p&gt;Arnold &amp;amp; Porter was recognized in &lt;em&gt;Law Times Korea&amp;rsquo;s&lt;/em&gt; 2026 Law Firm Consumer Report, which surveys in-house counsel on the performance of foreign law firms and joint venture law firms operating in Korea.&lt;/p&gt;</description><pubDate>Thu, 11 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter was recognized in &lt;em&gt;Law Times Korea&amp;rsquo;s&lt;/em&gt; 2026 Law Firm Consumer Report, which surveys in-house counsel on the performance of foreign law firms and joint venture law firms operating in Korea.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter received the most votes among foreign law firms and joint venture law firms in the &amp;lsquo;Best International Law Firm&amp;rsquo; category. &lt;em&gt;Law Times Korea&lt;/em&gt; noted the firm's reputation for advising clients on international disputes and international trade matters.&lt;/p&gt;
&lt;p&gt;Partner Soo-Mi Rhee was also recognized as one of the top three lawyers in the &amp;lsquo;Best Lawyers&amp;rsquo; category for foreign law firms and joint venture law firms. Soo-Mi leads Arnold &amp;amp; Porter&amp;rsquo;s Anti-Corruption practice and advises clients on anti-corruption compliance, export controls and economic sanctions, Committee on Foreign Investment in the United States (CFIUS) reviews, and U.S. outbound investment security regulations. According to the report, one in-house counsel noted that Soo-Mi &amp;ldquo;possesses deep expertise in international trade and provides prompt, practical advice tailored to clients&amp;rsquo; needs.&amp;rdquo;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F460F7DC-13DC-41B7-87E8-E4463781EAED}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/virginia-access-to-justice-commission-names-rosa-evergreen-a-pro-bono-service-champion</link><title>Virginia Access to Justice Commission Names Rosa Evergreen a Pro Bono Service Champion</title><description>&lt;p&gt;Rosa Evergreen was recently named a Pro Bono Service Champion by the Virginia Access to Justice Commission in recognition of her pro bono service during the 2024-2025 bar year.&lt;/p&gt;</description><pubDate>Thu, 11 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Rosa Evergreen was recently named a Pro Bono Service Champion by the Virginia Access to Justice Commission in recognition of her pro bono service during the 2024-2025 bar year.&lt;/p&gt;
&lt;p&gt;The distinction is awarded to the top 10 Virginia attorneys who reported a significant number of qualified pro bono service hours during the reporting year.&lt;/p&gt;
&lt;p&gt;Rosa was recognized at the Chief Justice&amp;rsquo;s Pro Bono Summit on June 11, 2026, and was featured in the June issue of &lt;em&gt;Virginia Lawyer &lt;/em&gt;magazine as one of this year&amp;rsquo;s honorees.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{354FE52B-CEB3-4D1F-B4C2-339E5CF65627}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/us-expands-cuba-sanctions</link><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Soo-Mi Rhee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rhee-soomi</a10:uri><a10:email>soo-mi.rhee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nicholas L. Townsend</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/townsend-nicholas-l</a10:uri><a10:email>nicholas.townsend@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tal R. Machnes</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/machnes-tal-r</a10:uri><a10:email>Tal.Machnes@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Junghyun Baek</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/baek-junghyun</a10:uri><a10:email>junghyun.baek@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Trevor G. Schmitt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmitt-trevor-g</a10:uri><a10:email>trevor.schmitt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bell Johnson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/johnson-bell</a10:uri><a10:email>bell.johnson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Adrienne K. Jackson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jackson-adrienne-k</a10:uri><a10:email>adrienne.jackson@arnoldporter.com</a10:email></a10:author><title>U.S. Expands Cuba Sanctions: Analysis of New Executive Order and Early Designations</title><description>President Trump&amp;rsquo;s Executive Order 14404 significantly expands U.S. sanctions targeting Cuba by creating a new sanctions regime that operates alongside existing Cuba sanctions, broadening the scope of sanctionable activities, and introducing secondary sanctions risks for foreign financial institutions. The executive order, coupled with a series of recent designations of Cuban government entities, officials, and companies, signals a more aggressive U.S. approach toward Cuba and raises important compliance considerations for businesses and financial institutions with Cuba-related operations or counterparties.</description><pubDate>Thu, 11 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On May 1, 2026, President Trump issued &lt;a rel="noopener noreferrer" href="https://ofac.treasury.gov/media/935581/download?inline" target="_blank"&gt;Executive Order 14404&lt;/a&gt; (&amp;ldquo;EO 14404&amp;rdquo; or &amp;ldquo;the Order&amp;rdquo;), expanding the scope of U.S. sanctions targeting Cuba. Building upon the national emergency the president declared in January 2026 (EO 14380), the Order introduces new authorities to target key sectors of the Cuban economy and impose secondary sanctions on foreign financial institutions (FFIs). EO 14404 establishes a new list based sanctions regime under the International Emergency Economic Powers Act (IEEPA) that operates alongside the longstanding Cuban Assets Control Regulations (CACR). In the last month, the administration has added more than 20 Cuban government entities, companies, and officials to the list of sanctioned entities. The latest developments signal a more aggressive U.S. sanctions posture toward Cuba and create new compliance considerations for U.S. and multinational companies with Cuba-related exposure.&lt;/p&gt;
&lt;h2&gt;Overview of the EO and Potential Implications &lt;/h2&gt;
&lt;p&gt;EO 14404 authorizes the U.S. Department of the Treasury (Treasury Department) and U.S. Department of State (State Department) to impose blocking sanctions on a wider range of individuals and entities. In particular, the Order targets persons determined to:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Operate in key sectors of the Cuban economy, including energy, defense, metals and mining, financial services, and security, as well as any other sector that the Treasury Department may identify in consultation with the State Department&lt;/li&gt;
    &lt;li&gt;Be owned or controlled by, or act on behalf of, the Cuban government or other designated persons or provide material, financial, technological, or other support to the Cuban government or blocked persons&lt;/li&gt;
    &lt;li&gt;To be or have been a leader, official, senior executive officer, or board member of the Cuban government or a blocked entity, or to constitute a political subdivision, agency, or instrumentality of the Cuban government&lt;/li&gt;
    &lt;li&gt;Be involved in corruption or serious human rights abuses connected to Cuba&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Notably, the Order expressly authorizes the designation of adult family members of individuals designated under the EO, reflecting an effort to prevent evasion of sanctions through family members or other indirect channels. Businesses that maintain relationships with Cuban officials or their associates should carefully assess whether counterparties have family connections to blocked persons in the event that the family members are also designated.&lt;/p&gt;
&lt;p&gt;EO 14404 also introduces a significant expansion of U.S. sanctions risk for non&lt;span&gt;‑&lt;/span&gt;U.S. financial institutions. In particular, the Order authorizes the Secretary of State, in consultation with the Secretary of the Treasury (or vice versa), to impose sanctions against FFIs that knowingly facilitate or conduct &amp;ldquo;significant transactions&amp;rdquo; on behalf of persons designated under the Order. &lt;/p&gt;
&lt;p&gt;This represents a notable change from the prior Cuban sanctions framework. Under the CACR, a foreign bank that processed a transaction involving a Cuban entity was generally not directly subject to U.S. sanctions, although exposure could arise where U.S. persons or the U.S. financial system (e.g., U.S.&lt;span&gt;‑&lt;/span&gt;dollar clearing) were involved. By contrast, under EO 14404, an FFI that conducts or facilitates a &amp;ldquo;significant transaction&amp;rdquo; for a blocked person may itself become subject to sanctions. The &amp;ldquo;significant transaction&amp;rdquo; threshold is not defined in the EO itself and may be elaborated in forthcoming guidance. OFAC has, however, addressed the term across several other sanctions programs. The most directly applicable framework comes from the Iran secondary sanctions program. In FAQ 208, OFAC identified a non-exhaustive list of factors it considers in determining whether a transaction is significant, including: the size, number, and frequency of the transactions; the nature of the transactions and their commercial purpose; the level of management awareness and whether the activity forms part of a pattern of conduct; the ultimate economic benefit conferred on the designated party; and whether deceptive financial practices were used to obscure the parties or nature of the transaction. &lt;/p&gt;
&lt;h2&gt;Designations&lt;/h2&gt;
&lt;p&gt;Pursuant to the new Order, the Treasury Department&amp;rsquo;s Office of Foreign Assets Control (OFAC) and the State Department acted in concert to add several entities and persons to OFAC&amp;rsquo;s Specially Designated Nationals (SDN) list.&lt;/p&gt;
&lt;p&gt;On May 7, 2026, the following entities and individuals were added: &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Grupo de Administraci&amp;oacute;n Empresarial S.A. (GAESA)&lt;/strong&gt;. The Cuban military conglomerate that controls an estimated 80% of Cuba&amp;rsquo;s economy &amp;mdash; including tourism, retail, and import/export &amp;mdash; was already one of the most significant blocked entities under the legacy Cuba program. However, its designation under EO 14404 raises compliance risks with regards to FFI given the potential for secondary sanctions. OFAC issued an FAQ, however, that clarifies that foreign persons, including FFIs, would not be targeted for transactions necessary to the wind down of involvement with GAESA as long as the wind down was completed by June 5, 2026. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Moa Nickel S.A.&lt;/strong&gt; One of Cuba&amp;rsquo;s largest mineral producers. Its re-designation under Cuba-EO confirms that OFAC is actively using the EO&amp;rsquo;s metals and mining sectoral authority. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Ania Guillermina Lastres Morera&lt;/strong&gt;. This individual was already listed on OFAC&amp;rsquo;s SDN List under the existing CACR program.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;On May 18, 2026, the following entities and individuals were added: &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Cuba&amp;rsquo;s Ministry of Interior (MININT)&lt;/strong&gt;. Cuba&amp;rsquo;s agency for internal security, including Cuba&amp;rsquo;s police and internal security forces, intelligence agencies, and prison system. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;The Policia Nacional Revolucionaria (PNR)&lt;/strong&gt;. A police force under MININT accused of operating mobile prisons and suppressing protests. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Cuba&amp;rsquo;s Directorate of Intelligence (DGI)&lt;/strong&gt;. The lead intelligence agency under MININT. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Eleven senior Cuban government officials and military figures&lt;/strong&gt;, including Luis Alberto Rodr&amp;iacute;guez L&amp;oacute;pez-Calleja, who heads GAESA; and Rosabel Gam&amp;oacute;n Verde, Minister of Justice.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;On June 4, 2026, the following entities and individuals were added: &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Ministry of the Revolutionary Armed Forces of Cuba (MINFAR)&lt;/strong&gt;. Cuba&amp;rsquo;s defense ministry. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Minera La Victoria S.A.&lt;/strong&gt; A metals mining company based in Havana. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;The Committees for the Defense of the Revolution (CDR)&lt;/strong&gt;. The Cuban neighborhood surveillance group established in 1960. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;The Cuban Institute of Friendship with the Peoples (ICAP) and Amistur Cuba S.A.&lt;/strong&gt; A Cuban government entity involved in Cuba&amp;rsquo;s foreign outreach activities. Amistur Cuba S.A. is a travel agency linked to ICAP. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Miguel D&amp;iacute;az-Canal Berm&amp;uacute;dez&lt;/strong&gt;. Cuba&amp;rsquo;s president. His wife, Lis Cuesta Peraza, was also designated. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Alejandro Castro Esp&amp;iacute;n (El Tuerto)&lt;/strong&gt;. A senior figure in Cuba&amp;rsquo;s security and intelligence communities and the son of Ra&amp;uacute;l Castro.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;U.S. persons, including U.S. financial institutions, are generally prohibited from engaging in any transaction with SDNs and are required to block (i.e., freeze) any property or interests in property belonging to SDNs.&lt;/p&gt;
&lt;h2&gt;General Licenses and FAQs&lt;/h2&gt;
&lt;p&gt;In addition to the sanction designations, OFAC also published General License 1 (GL 1), which authorizes transactions otherwise prohibited by EO 14404 where those transactions are already authorized or exempt under the CACR. GL 1 covers activity licensed under either a general or specific license issued pursuant to the CACR.&lt;/p&gt;
&lt;p&gt;GL 1 ensures that the EO does not inadvertently disrupt commercial activity that was already permissible under the existing Cuba sanctions framework. The clearest illustration is GAESA. Without GL 1, a U.S. person holding a specific CACR license to transact with GAESA could have faced ambiguity about whether the EO&amp;rsquo;s separate blocking authority created an additional legal obstacle. GL 1 resolves that ambiguity &amp;mdash; where a transaction is authorized or exempt under the CACR, no separate authorization under the EO is required.&lt;/p&gt;
&lt;p&gt;Transactions that are not authorized or exempt under the CACR remain prohibited and require separate OFAC authorization to proceed.&lt;/p&gt;
&lt;p&gt;Alongside GL 1, OFAC published six new FAQs (FAQs 1251-1256) providing initial guidance on EO 14404. &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1251&lt;/strong&gt; provides a summary of EO 14404. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1252&lt;/strong&gt; confirms that EO 14404 does not alter or replace the existing CACR. The two regimes run in parallel. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1253&lt;/strong&gt; explains GL 1, which authorizes transactions prohibited by EO 14404 where those transactions are already authorized or exempt under the CACR. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1254&lt;/strong&gt; confirms that foreign persons (including FFIs) are generally at risk for transacting with GAESA following its designation. However, OFAC stated that it does not intend to target &lt;em&gt;non-U.S. persons&lt;/em&gt; for winding down existing GAESA relationships, as long as that wind-down is completed by June 5, 2026. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1255&lt;/strong&gt; clarifies that being blocked under the CACR does not automatically result in being blocked under EO 14404, and vice versa. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1256&lt;/strong&gt; clarifies that operating in one of the five named sectors does not automatically make a person/entity a sanctions target. Sector designation creates exposure, but OFAC must separately determine that a foreign person meets the criteria. &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;FAQ 1258&lt;/strong&gt; confirms that non-U.S. persons who transact with GAESA, MININT, MINFAR, and/or their subsidiaries run the risk of being sanctioned themselves.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The Order materially expands the Cuba sanctions landscape and, when viewed alongside the underlying national emergency declared in EO 14380, reflects a significantly more aggressive U.S. policy posture toward Cuba, with additional designations likely to follow.&lt;/p&gt;
&lt;p&gt;Companies and FFI with any Cuba-related exposure should closely monitor further guidance and enforcement actions by the U.S. government. In particular, parties should implement procedures to screen against OFAC&amp;rsquo;s SDN List on a regular, ongoing basis, where not already in place, as new designations could be announced at any time. Companies should also evaluate their exposure to Cuba across key sectors &amp;mdash; especially energy, defense, metals and mining, financial services, and security &amp;mdash; as activities involving these areas warrant heightened scrutiny. Financial institutions should assess whether existing transaction flows or correspondent relationships involve parties that could plausibly be designated and consider whether enhanced due diligence or risk-based exit planning or decisions are appropriate in advance of new listings. Finally, parties relying on existing authorizations under the CACR should confirm that both their activities and counterparties remain permissible under the evolving framework, recognizing that a new designation may create compliance risks even where the underlying activity is otherwise licensed.&lt;/p&gt;
&lt;p&gt;If you have questions about this Advisory or sanctions compliance, please contact your Arnold &amp;amp; Porter relationship attorney or any member of our &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/national-security/export-control-and-sanctions" target="_self"&gt;Export Control &amp;amp; Sanctions&lt;/a&gt; practice.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C94DA496-220D-4168-A280-7588AF5DE5F2}</guid><link>https://assetrecoverycee.com/</link><author>Bart.Wasiak@arnoldporter.com</author><title>Frozen Russian Assets and Ukraine – Legal and Investigative Pathways</title><pubDate>Thu, 11 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{2F5247AF-55B6-4D3D-95D3-7CB201734CA3}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/the-legal-500-united-states-2026</link><title>The Legal 500 United States 2026 Recognizes Arnold &amp; Porter Lawyers, Practices</title><description>&lt;p&gt;The 2026 edition of &lt;em&gt;The Legal 500 United States&lt;/em&gt; recognized 50 Arnold &amp;amp; Porter practice areas and 159 lawyers, including 30 lawyers who were distinguished as &amp;ldquo;Leading Partners,&amp;rdquo; eight lawyers as &amp;ldquo;Next Generation Partners,&amp;rdquo; and one lawyer as a &amp;ldquo;Leading Associate.&amp;rdquo; Six Arnold &amp;amp; Porter lawyers were also included in&lt;em&gt; The Legal 500&amp;rsquo;&lt;/em&gt;s &amp;ldquo;Hall of Fame,&amp;rdquo; a recognition achieved by lawyers who are &amp;ldquo;widely regarded as being at the very top of the profession&amp;rdquo; and who have been consistently ranked as leading individuals by &lt;em&gt;The Legal 500&lt;/em&gt; for a number of years.&lt;/p&gt;</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 2026 edition of &lt;em&gt;The Legal 500 United States&lt;/em&gt; recognized 50 Arnold &amp;amp; Porter practice areas and 159 lawyers, including 30 lawyers who were distinguished as &amp;ldquo;Leading Partners,&amp;rdquo; eight lawyers as &amp;ldquo;Next Generation Partners,&amp;rdquo; and one lawyer as a &amp;ldquo;Leading Associate.&amp;rdquo; Six Arnold &amp;amp; Porter lawyers were also included in&lt;em&gt; The Legal 500&amp;rsquo;&lt;/em&gt;s &amp;ldquo;Hall of Fame,&amp;rdquo; a recognition achieved by lawyers who are &amp;ldquo;widely regarded as being at the very top of the profession&amp;rdquo; and who have been consistently ranked as leading individuals by &lt;em&gt;The Legal 500&lt;/em&gt; for a number of years.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;The Legal 500&lt;/em&gt; commended Arnold &amp;amp; Porter for its &amp;ldquo;depth and global reach,&amp;rdquo; noting the firm &amp;ldquo;leverages its national footprint to advise clients on a wide range of multi-jurisdictional matters.&amp;rdquo; The publication also highlighted that Arnold &amp;amp; Porter &amp;ldquo;stands out for its work on regulatory, compliance, and enforcement matters&amp;rdquo; and is &amp;ldquo;well-equipped to support clients in complex disputes, transactions and day-to-day counselling [&amp;hellip;] across a diverse range of industries.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The guide features coverage of the U.S. legal market, highlighting emerging trends and developments across the jurisdiction&amp;rsquo;s leading firms through extensive research and feedback from in-house counsel and lawyers worldwide.&lt;/p&gt;
&lt;p&gt;The following practices were recommended by The Legal 500 United States 2026:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Antitrust: Cartel &lt;/li&gt;
    &lt;li&gt;Antitrust: Civil Litigation/Class Actions: Defense &lt;/li&gt;
    &lt;li&gt;Antitrust: Merger Control &lt;/li&gt;
    &lt;li&gt;Appellate: Courts of Appeals &lt;/li&gt;
    &lt;li&gt;Appellate: Supreme Courts (States and Federal) &lt;/li&gt;
    &lt;li&gt;Capital Markets: Equity Offerings: Advice to Issuers &lt;/li&gt;
    &lt;li&gt;Capital Markets: Global Offerings: Advice to Issuers &lt;/li&gt;
    &lt;li&gt;Corporate Governance &lt;/li&gt;
    &lt;li&gt;Corporate Investigations and White-Collar Criminal Defense &amp;ndash; Advice to Corporates &lt;/li&gt;
    &lt;li&gt;Corporate Investigations and White-Collar Criminal Defense &amp;ndash; Advice to Individuals &lt;/li&gt;
    &lt;li&gt;Energy Litigation: Oil and Gas &amp;ndash; Mid-Market ($0-500m)&lt;/li&gt;
    &lt;li&gt;Energy Regulation: Electric Power &lt;/li&gt;
    &lt;li&gt;Energy: Renewable/Alternative Power &lt;/li&gt;
    &lt;li&gt;Environment: Litigation &lt;/li&gt;
    &lt;li&gt;Environment: Regulatory &lt;/li&gt;
    &lt;li&gt;Financial Services Regulation: Banking &lt;/li&gt;
    &lt;li&gt;Financial Services Regulation: Consumer Finance &lt;/li&gt;
    &lt;li&gt;Financial Services: Litigation &lt;/li&gt;
    &lt;li&gt;Fintech &lt;/li&gt;
    &lt;li&gt;General Commercial Disputes &lt;/li&gt;
    &lt;li&gt;Government Contracts &lt;/li&gt;
    &lt;li&gt;Government Relations &lt;/li&gt;
    &lt;li&gt;Healthcare: Life Sciences &lt;/li&gt;
    &lt;li&gt;Healthcare: Service Providers &lt;/li&gt;
    &lt;li&gt;Insurance: Advice to Insurers &lt;/li&gt;
    &lt;li&gt;Intellectual Property: Copyright &lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patents: Litigation (Full Coverage) &lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patents: Prosecution (Including Re-Examination and Post-Grant Proceedings) &lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademarks: Litigation &lt;/li&gt;
    &lt;li&gt;International Arbitration &lt;/li&gt;
    &lt;li&gt;International Litigation &lt;/li&gt;
    &lt;li&gt;International Trade and National Security: Trade Remedies and Trade Policy &lt;/li&gt;
    &lt;li&gt;M&amp;amp;A: Middle-Market (sub-$500m) &lt;/li&gt;
    &lt;li&gt;Media, Technology and Telecoms: Cyber Law (Including Data Privacy and Protection) &lt;/li&gt;
    &lt;li&gt;Media, Technology and Telecoms: Outsourcing &lt;/li&gt;
    &lt;li&gt;Media, Technology and Telecoms: Telecoms and Broadcast: Regulatory &lt;/li&gt;
    &lt;li&gt;Media, Technology and Telecoms: Telecoms and Broadcast: Transactions &lt;/li&gt;
    &lt;li&gt;Product Liability, Mass Tort and Class Action - Defense: Consumer Products (Including Tobacco) &lt;/li&gt;
    &lt;li&gt;Product Liability, Mass Tort and Class Action - Defense: Pharmaceuticals and Medical Devices &lt;/li&gt;
    &lt;li&gt;Product Liability, Mass Tort and Class Action - Defense: Toxic Tort &lt;/li&gt;
    &lt;li&gt;Real Estate Finance &lt;/li&gt;
    &lt;li&gt;Real Estate: Mid-Market ($0-500m) &lt;/li&gt;
    &lt;li&gt;Restructuring (Including Bankruptcy): Corporate &lt;/li&gt;
    &lt;li&gt;Securities Litigation: Defense &lt;/li&gt;
    &lt;li&gt;Sport &lt;/li&gt;
    &lt;li&gt;State Attorneys General &lt;/li&gt;
    &lt;li&gt;Structured Finance: Securitization &lt;/li&gt;
    &lt;li&gt;Tax: Non-Contentious &lt;/li&gt;
    &lt;li&gt;Tax: Not-For-Profit (Fortune 1000 Private Foundations, National Trade Associations, and Charities) &lt;/li&gt;
    &lt;li&gt;Transport: Aviation and Air Travel: Regulation and Litigation&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following lawyers were ranked in the &amp;ldquo;Hall of Fame&amp;rdquo;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Anand Agneshwar &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Pharmaceuticals and Medical Devices&lt;/li&gt;
    &lt;li&gt;Paolo Di Rosa &amp;mdash; International Arbitration&lt;/li&gt;
    &lt;li&gt;Debbie Feinstein &amp;mdash; Antitrust: Merger Control&lt;/li&gt;
    &lt;li&gt;Jeffrey L. Handwerker &amp;mdash; Healthcare: Life Sciences&lt;/li&gt;
    &lt;li&gt;Daniel A. Kracov &amp;mdash; Healthcare: Life Sciences&lt;/li&gt;
    &lt;li&gt;Kevin J. Lavin &amp;mdash; M&amp;amp;A: Middle-Market (sub-$500m)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following lawyers were ranked as &amp;ldquo;Leading Partners&amp;rdquo;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Michael B. Bernstein &amp;mdash; Antitrust: Merger Control&lt;/li&gt;
    &lt;li&gt;Arthur E. Brown &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Pharmaceuticals and Medical Devices&lt;/li&gt;
    &lt;li&gt;Maria Chedid &amp;mdash; International Arbitration&lt;/li&gt;
    &lt;li&gt;Lauren Daniel &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Toxic Tort&lt;/li&gt;
    &lt;li&gt;Kara L. Daniels &amp;mdash; Government Contracts&lt;/li&gt;
    &lt;li&gt;Michael D. Daneker &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Toxic Tort&lt;/li&gt;
    &lt;li&gt;Mahnu V. Davar &amp;mdash; Healthcare: Life Sciences&lt;/li&gt;
    &lt;li&gt;Edward A. Deibert &amp;mdash; M&amp;amp;A: Middle-Market (sub-$500m) &lt;/li&gt;
    &lt;li&gt;John P. Elwood &amp;mdash; Appellate: Courts of Appeals/Appellate: Supreme Courts (States and Federal)&lt;/li&gt;
    &lt;li&gt;David F. Freeman, Jr. &amp;mdash; Financial Services Regulation&lt;/li&gt;
    &lt;li&gt;Andre Geverola &amp;mdash; Antitrust: Cartel&lt;/li&gt;
    &lt;li&gt;Jonathan Gleklen &amp;mdash; Antitrust: Merger Control&lt;/li&gt;
    &lt;li&gt;Stephen Gliatta &amp;mdash; Real Estate Finance&lt;/li&gt;
    &lt;li&gt;Kristin M. Hicks &amp;mdash; Healthcare: Life Sciences&lt;/li&gt;
    &lt;li&gt;M&amp;eacute;lida Hodgson &amp;mdash; International Arbitration&lt;/li&gt;
    &lt;li&gt;Craig Holman &amp;mdash; Government Contracts&lt;/li&gt;
    &lt;li&gt;Maureen R. Jeffreys &amp;mdash; Media, Technology and Telecoms: Telecoms and Broadcast: Transactions&lt;/li&gt;
    &lt;li&gt;James P. Joseph &amp;mdash; Tax: Not-for-Profit&lt;/li&gt;
    &lt;li&gt;Allon Kedem &amp;mdash; Appellate: Courts of Appeals/Appellate: Supreme Courts (States and Federal)&lt;/li&gt;
    &lt;li&gt;Jonathan S. Martel &amp;mdash; Environment: Regulatory&lt;/li&gt;
    &lt;li&gt;Daphne O&amp;rsquo;Connor &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Consumer Products (Including Tobacco)&lt;/li&gt;
    &lt;li&gt;Christopher M. Odell &amp;mdash; International Litigation&lt;/li&gt;
    &lt;li&gt;Kevin O&amp;rsquo;Neill &amp;mdash; Government Relations&lt;/li&gt;
    &lt;li&gt;J. David Park &amp;mdash; International Trade and National Security: Trade Remedies and Trade Policy&lt;/li&gt;
    &lt;li&gt;Elissa J. Preheim &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Toxic Tort&lt;/li&gt;
    &lt;li&gt;Sandra E. Rizzo &amp;mdash; Energy Regulation: Electric Power&lt;/li&gt;
    &lt;li&gt;Allison B. Rumsey &amp;mdash; Environment: Litigation&lt;/li&gt;
    &lt;li&gt;Paige Hester Sharpe &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Pharmaceuticals and Medical Devices&lt;/li&gt;
    &lt;li&gt;Ethan G. Shenkman &amp;mdash; Environment: Regulatory&lt;/li&gt;
    &lt;li&gt;Allison W. Shuren &amp;mdash; Healthcare: Service Providers&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following lawyers were ranked as &amp;ldquo;Next Generation Partners&amp;rdquo;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Michelle F. Gillice &amp;mdash; Product Liability, Mass Tort and Class Action &amp;ndash; Defense: Consumer Products (Including Tobacco)&lt;/li&gt;
    &lt;li&gt;Sarah Grey &amp;mdash; Environment: Regulatory&lt;/li&gt;
    &lt;li&gt;Abeba Habtemariam &amp;mdash; Healthcare: Life Sciences&lt;/li&gt;
    &lt;li&gt;Stacey Halliday &amp;mdash; Environment: Regulatory&lt;/li&gt;
    &lt;li&gt;Michael Kim Krouse &amp;mdash; Corporate Investigations and White-Collar Criminal Defense&lt;/li&gt;
    &lt;li&gt;Elissa J. Preheim &amp;mdash; Environment: Litigation &lt;/li&gt;
    &lt;li&gt;Christian D. Sheehan &amp;mdash; Corporate Investigations and White-Collar Criminal Defense&lt;/li&gt;
    &lt;li&gt;Elisabeth S. Theodore &amp;mdash; Appellate: Courts of Appeals/Appellate: Supreme Courts (States and Federal)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following lawyer was ranked as a &amp;ldquo;Leading Associate&amp;rdquo;:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Alice Ho &amp;mdash; Intellectual Property: Patents: Prosecution (Including Re-Examination and Post-Grant Proceedings)&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{5FCBA877-BCC7-4149-B384-9A4FA2475FD1}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/06/eva-temkin-quoted-in-biospace-on-fdas-expanding-rare-disease-regulatory-framework</link><title>Eva Temkin Quoted in BioSpace on FDA’s Expanding Rare Disease Regulatory Framework</title><description>Eva Temkin, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)&amp;rsquo;s Office of Therapeutic Biologics and Biosimilars, was quoted in the BioSpace article, &amp;ldquo;Busy FDA gives rare disease sector complementary pathways, unanswered questions.&amp;rdquo;</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Eva Temkin, Arnold &amp;amp; Porter Life Sciences &amp;amp; Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)&amp;rsquo;s Office of Therapeutic Biologics and Biosimilars, was quoted in the &lt;em&gt;BioSpace&lt;/em&gt; article, &amp;ldquo;Busy FDA gives rare disease sector complementary pathways, unanswered questions.&amp;rdquo; The article discusses the U.S. Food and Drug Administration&amp;rsquo;s (FDA) recently introduced rare disease initiatives and how they fit within the agency&amp;rsquo;s broader expedited development programs.&lt;/p&gt;
&lt;p&gt;Addressing the relationship between the FDA&amp;rsquo;s newer rare disease-focused mechanisms and existing regulatory pathways, Eva noted that sponsors should view them as &amp;ldquo;complementary,&amp;rdquo; though she advised that they &amp;ldquo;should also be mindful that they are not substitutes or alternatives.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;She explained that the FDA&amp;rsquo;s Plausible Mechanism Pathway differs from traditional expedited programs because it is a &amp;ldquo;very narrow construct under which specific types of evidence may be considered sufficient under a specified set of circumstances.&amp;rdquo; By contrast, established programs such as Fast Track, Breakthrough Therapy designation, and Priority Review &amp;ldquo;address more programmatic considerations,&amp;rdquo; including agency interactions and review timelines for promising therapies addressing unmet medical needs. Eva also highlighted several unresolved questions surrounding the Plausible Mechanism Pathway, including its implications for postmarketing obligations, regulatory exclusivity, and commercial incentives.&lt;/p&gt;
&lt;p&gt;In discussing the FDA&amp;rsquo;s Platform Technology Designation program, Eva observed that sponsors &amp;ldquo;are unlikely to see great utility in the program until the second or third submission based on the platform technology,&amp;rdquo; underscoring the program&amp;rsquo;s long-term value for companies developing multiple products from a common platform.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.biospace.com/fda/busy-fda-gives-rare-disease-sector-complementary-pathways-unanswered-questions" target="_blank"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A4647656-6207-4965-B302-ED06E9A5852F}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/bowery-residents-committee-recognizes-arnold-porter</link><title>Bowery Residents’ Committee Recognizes Arnold &amp; Porter</title><description>Arnold &amp;amp; Porter was recently honored at the Bowery Residents&amp;rsquo; Committee&amp;rsquo;s 2026 The Way Home Gala, recognizing the firm for its pro bono support.</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter was recently honored at the Bowery Residents&amp;rsquo; Committee&amp;rsquo;s 2026 The Way Home Gala, recognizing the firm for its pro bono support.&lt;/p&gt;
&lt;p&gt;The firm regularly assists BRC, a New York City-based nonprofit, providing counsel ranging from commercial litigation advice to transactional support.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter alum Richard Swanson presented the award, which Securities Enforcement &amp;amp; Litigation Chair Veronica Callahan and associate Chasity Fair accepted on behalf of the firm. The event was held on June 8 at the Ziegfeld Ballroom in New York.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9D0D291E-4C75-4231-A62B-D3CF252F14E4}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/financial-news-again-names-kathleen-harris</link><title>Financial News Again Names Kathleen Harris One of Europe’s 50 Most Influential Lawyers</title><description>&lt;p&gt;Arnold &amp;amp; Porter partner Kathleen Harris, who heads the firm's London office, has been named to&lt;em&gt; Financial News&amp;rsquo;&lt;/em&gt; list of "Fifty Most Influential Lawyers 2026,&amp;rdquo; which celebrates the top legal professionals working in Europe.&lt;/p&gt;</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Kathleen Harris, who heads the firm's London office, has been named to&lt;em&gt; Financial News&amp;rsquo;&lt;/em&gt; list of "Fifty Most Influential Lawyers 2026,&amp;rdquo; which celebrates the top legal professionals working in Europe.&lt;/p&gt;
&lt;p&gt;In its profile, &lt;em&gt;Financial News &lt;/em&gt;describes Kathleen as "a leader in the field of financial crime, regulatory enforcement and investigations.&amp;rdquo; Kathleen regularly advises FTSE 100 companies and senior executives on complex regulatory and criminal matters and is recognized internationally as a leader in her field. She is an accomplished litigator with extensive knowledge of and experience in matters involving internal and external investigations and prosecutions under the full range of potential criminal offenses and sanctions. Financial News also highlighted Kathleen&amp;rsquo;s passion for mentoring and broadening access to the profession, noting that she is &amp;ldquo;not a pull-up-the-drawbridge person but someone who likes to shove that ladder down.&amp;rdquo;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{718987F8-D650-4BED-9AE4-281CCECF1B81}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/fda-proposes-revised-payor-communications-draft-guidance</link><a10:author><a10:name>Daniel A. Kracov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kracov-daniel-a</a10:uri><a10:email>daniel.kracov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eva Temkin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/temkin-eva</a10:uri><a10:email>eva.temkin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mahnu V. Davar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/davar-mahnu-v</a10:uri><a10:email>mahnu.davar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ada Ohanenye</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/ohanenye-ada</a10:uri><a10:email>ada.ohanenye@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jonathan Trinh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/trinh-jonathan</a10:uri><a10:email>Jonathan.Trinh@arnoldporter.com</a10:email></a10:author><title>FDA Proposes Revised Payor Communications Draft Guidance to Formally Include Devices and Reflect New Statutory Safe Harbor While Balancing Substantial Government Interests</title><description>The U.S. Food and Drug Administration&amp;rsquo;s 2026 Draft Payor Guidance would update the framework for communications between drug and device manufacturers and payors, including guidance on healthcare economic information, pre-approval communications, and information about unapproved uses of approved or cleared medical products. The draft guidance reflects recent statutory changes under the Pre-Approval Information Exchange Act, extends key protections to medical devices, and offers greater clarity for life sciences companies while leaving some practical implementation questions unresolved.</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On June 3, 2026, the U.S. Food and Drug Administration (FDA or the Agency) issued a new draft guidance titled &lt;a href="https://www.fda.gov/media/133620/download" target="_self"&gt;Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities &amp;mdash; Questions and Answers&lt;/a&gt; (the 2026 Draft Payor Guidance). Once finalized, the 2026 Draft Payor Guidance will replace the 2018 final guidance on the same topic. The 2026 Draft Payor Guidance provides updated answers to commonly asked questions regarding the communication from firms to payors of: (1) healthcare economic information (HCEI) about approved or cleared prescription drugs and medical devices; (2) information about prescription drugs or medical devices for which approval or clearance is forthcoming; and (3) information about unapproved uses of approved or cleared prescription drugs or medical devices. It also reinforces how FDA has referred to the substantial government interests at play in the Agency&amp;rsquo;s regulation of drug and device sponsors&amp;rsquo; commercial speech, discussed in more detail below. &lt;/p&gt;
&lt;p&gt;The 2026 Draft Payor Guidance largely reflects the recent statutory amendments and additions to the Federal Food, Drug, and Cosmetic Act (FD&amp;amp;C Act), which were enacted by the Pre-Approval Information Exchange (PIE) Act.[[N:Section 3630 of the Consolidated Appropriations Act, 2023 (the Pre-approval Information Exchange Act), Pub. L. No. 117-328, 136 Stat. 4459, 5893&amp;ndash;95 (2022).]] In particular, amendments to section 502(a) of the FD&amp;amp;C Act extended HCEI provisions to medical devices; the addition of section 502(gg) provided that &amp;ldquo;no drug or device shall be deemed to be misbranded&amp;rdquo; as a result of the provision of certain types of truthful and not misleading information to payors and other similarly situated entities (collectively &amp;ldquo;payors&amp;rdquo;). &lt;/p&gt;
&lt;p&gt;The updated 2026 Draft Payor Guidance brings FDA&amp;rsquo;s payor communications framework more closely in line with these statutory provisions, providing firms with greater regulatory clarity and predictability regarding communications with payors about their medical products. The draft guidance also extends beyond the PIE Act provisions by applying a similar framework to communications of product information for unapproved medical products and unapproved uses of approved/cleared medical products. Because such communications are not expressly addressed by either section 502(a) or section 502(gg), this aspect of the 2026 Draft Payor Guidance appears intended to address a potential gap in FDA&amp;rsquo;s approach to payor communications. &lt;/p&gt;
&lt;p&gt;Despite providing greater clarity in several areas, the 2026 Draft Payor Guidance leaves certain practical implementation questions unresolved, including how firms are expected to satisfy the requirement to provide updated information when previously communicated information becomes materially outdated. Firms should continue to monitor the development of the guidance and evaluate whether existing market access, health economics, and managed care communication practices adequately address these evolving expectations.&lt;/p&gt;
&lt;p&gt;The 2026 Draft Payor Guidance, if finalized, will replace the Agency&amp;rsquo;s final guidance bearing the same name that was released in June 2018. We covered the 2018 final guidance in a &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2018/06/fda-finalizes-guidance-documents-on-payor" target="_self"&gt;June 2018 Advisory&lt;/a&gt;. &lt;/p&gt;
&lt;h2&gt;Key Proposed Updates&lt;/h2&gt;
&lt;h3&gt;A Single Framework for Drugs and Devices&lt;/h3&gt;
&lt;p&gt;Consistent with the statutory amendments (described in further detail below), the 2026 Draft Payor Guidance broadens its recommendations to devices &amp;mdash; not only prescription drugs. It refers to prescription drugs and devices together as &amp;ldquo;medical products.&amp;rdquo;[[N:2026 Draft Payor Guidance, supra note 1, at 1.]] As a result, FDA puts forth a uniform framework for understanding the Agency&amp;rsquo;s position regarding communications from firms to payors.&lt;/p&gt;
&lt;p&gt;This uniform framework includes the extension of the section 502(a) HCEI-related safe harbor protections to devices. Section 502(a) previously applied only to drugs (the 2018 final guidance had taken the position that, while the then-section 502(a) language applied only to drugs, the Agency&amp;rsquo;s recommendations with respect to HCEI communications to payors would be generally applicable to devices as well).[[N:U.S. Food &amp;amp; Drug Admin., &lt;a rel="noopener noreferrer" href="Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers 3-4" target="_blank"&gt;Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities &amp;mdash; Questions and Answers 3-4&lt;/a&gt; (June 2018).]] The 2026 Draft Guidance formally extends the safe harbor protections to devices, providing that the provision of HCEI to a payor shall &lt;em&gt;not&lt;/em&gt; be considered to be false or misleading (and shall not misbrand a drug or device) if the HCEI relates to an approved indication, is based on competent and reliable scientific evidence, and, where applicable, includes a conspicuous and prominent statement describing any material differences between the HCEI and approved labeling for the drug or device.[[N:21 U.S.C. &amp;sect; 352(a).]]&lt;/p&gt;
&lt;p&gt;The 2026 Draft Payor Guidance also clarifies that its HCEI-related recommendations do not apply to the dissemination of HCEI to non-payor audiences, such as healthcare providers who make individual patient prescribing decisions or consumers.[[N:2026 Draft Payor Guidance, supra note 1, at 6-7.]]&lt;/p&gt;
&lt;h3&gt;Establishment of a Statutory Safe Harbor for Communicating Information About Investigational Medical Products and Investigational Uses&lt;/h3&gt;
&lt;p&gt;FDA&amp;rsquo;s prior guidance had created an enforcement discretion policy pertaining to communications about certain pre-approval communications. Now, in what may be the most significant change from prior guidance, the 2026 Draft Payor Guidance implements the statutory safe harbor for communications about investigational products and uses established by the PIE Act in section 502(gg) of the FD&amp;amp;C Act. Section 502(gg) establishes a framework for communicating truthful and not misleading product information to a payor about an investigational drug or device or investigational use of an approved or cleared drug or device.[[N:21 U.S.C. &amp;sect; 352(gg).]] Consistent with that safe harbor, relevant pre-approval communications to payors will not misbrand medical products as long as the communications meet the following conditions:[[N:See 2026 Draft Payor Guidance, supra note 1, at 18.]]&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The information being communicated is the type of &amp;ldquo;product information&amp;rdquo; described in section 502(gg): information describing the product, information about the indication(s) under investigation, the anticipated timeline for potential FDA approval or clearance, medical product pricing information, patient utilization projections, medical product-related programs and services, and factual presentations of clinical study results.[[N:Id. at 17.]]&lt;/li&gt;
    &lt;li&gt;The information is truthful and not misleading.&lt;/li&gt;
    &lt;li&gt;The required disclosures set forth in section 502(gg)(1)(A) are provided, as applicable, including a clear statement that the investigational drug, device, or use has not been approved or cleared, information related to the stage of development of the drug or device, a description of all material aspects of study design, methodology, results, and limitations, a prominent statement disclosing the approved or cleared indication(s) and copy of the most current FDA-required labeling, and &amp;ldquo;&lt;em&gt;updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status&lt;/em&gt;.&amp;rdquo;[[N:Id. at 19.]]&lt;/li&gt;
    &lt;li&gt;The communication does &lt;em&gt;not&lt;/em&gt; include the prohibited information in section 502(gg)(1)(B), i.e., information that represents that an unapproved medical product or unapproved use of an approved/cleared medical product has been approved or cleared or has been determined to be safe or effective for the purpose(s) for which it is being studied.[[N:Id. at 20.]]&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;Information Beyond Investigational Products and Uses&lt;/h3&gt;
&lt;p&gt;Going beyond investigational medical products or investigational uses of approved/cleared medical products, the 2026 Draft Payor Guidance takes the position that FDA does not intend to object to a firm&amp;rsquo;s communication of product information to payors about &lt;em&gt;unapproved&lt;/em&gt; medical products or &lt;em&gt;unapproved&lt;/em&gt; uses of approved/cleared medical products, even when such products or uses may not be considered investigational, as long as the communications are consistent with the requirements of section 502(gg).[[N:Id. at 18.]] The 2026 Draft Payor Guidance explains that such policy recognizes the fact that some payors may need to plan for and make coverage and reimbursement decisions far in advance of the effective date of such decisions, so there is an interest in providing information to payors about unapproved medical products and unapproved uses of approved/cleared medical products.[[N:91 Fed Reg at 33183; 2026 Draft Payor Guidance, supra note 1, at 4.]]&lt;/p&gt;
&lt;h3&gt;Updating Information to Payors&lt;/h3&gt;
&lt;p&gt;As noted above, the 2026 Draft Payor Guidance highlights the requirement under section 502(gg) for firms to provide &amp;ldquo;updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status.&amp;rdquo;[[N:21 U.S.C. &amp;sect; 352(gg)(1)(A)(v).]] The 2026 Draft Payor Guidance suggests that firms should notify payors of changes or new information, such as the failure to meet the primary effectiveness endpoint in a pivotal trial, the receipt of a Complete Response Letter, or the imposition of a clinical hold by FDA.[[N:2026 Draft Payor Guidance, supra note 1, at 19-20.]]&lt;/p&gt;
&lt;p&gt;Notably, however, the draft guidance provides little clarity regarding how this obligation should be implemented in practice. For example, FDA does not specify the timing for providing updated information, whether updates must be communicated through the same channel as the original communication, or what form such updates should take. As a result, firms may need to develop internal processes for identifying material developments and determining when previously communicated information should be supplemented or corrected.&lt;/p&gt;
&lt;h2&gt;First Amendment Considerations&lt;/h2&gt;
&lt;p&gt;As FDA is keenly aware in the recent environment of heightened enforcement, the Agency must justify regulating or restricting otherwise protected commercial speech by demonstrating that it is advancing a &amp;ldquo;substantial&amp;rdquo; government interest. The 2026 Draft Payor Guidance justifies its recommendations as an attempt to balance the potentially competing interests at play here: the interests of payors to receive information from firms about unapproved medical products and unapproved uses of approved/cleared medical products against the substantial government interests related to health and safety.[[N:Id. at 4.]]&lt;/p&gt;
&lt;p&gt;The 2026 Draft Payor Guidance acknowledges that &amp;ldquo;in some situations, payors need to plan for and make coverage and reimbursement decisions for medical products and uses far in advance of the effective date of such decisions. In making decisions on a population basis, payors can draw on a range of expertise in multiple disciplines that allows them to critically evaluate information presented to them by firms, including an evaluation of the limitations and reliability of that information.&amp;rdquo; Accordingly, &amp;ldquo;FDA recognizes the value of payors receiving truthful and not misleading information about unapproved medical products and unapproved uses of approved/cleared medical products, as described in section 502(gg) of the FD&amp;amp;C Act, in order to inform their decision-making.&amp;rdquo;[[N:Id.]]&lt;/p&gt;
&lt;p&gt;However, the draft guidance also describes the substantial government interests at stake. The 2026 Draft Payor Guidance lists those interests as including: &lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Motivating the development of robust scientific data on safety and effectiveness&lt;/li&gt;
    &lt;li&gt;Maintaining the premarket review process for safety and effectiveness of each intended use in order to prevent harm; to protect against fraud, misrepresentation, and bias; and to develop appropriate instructions for use for medical products&lt;/li&gt;
    &lt;li&gt;Protecting the integrity and reliability of promotional information regarding medical product uses&lt;/li&gt;
    &lt;li&gt;Preventing the diversion of healthcare resources toward ineffective treatments[[N:Id.]]&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;FDA believes that the updated recommendations in the 2026 Draft Payor Guidance continue to balance the interests of payors and the substantial government interests &amp;ldquo;to best advance the public health overall.&amp;rdquo;[[N:Id.]]&lt;/p&gt;
&lt;p&gt;While FDA articulated these potentially competing interests in the 2018 final guidance as well, the 2026 Draft Payor Guidance appears to soften restrictions on firm communications in other facets. For example, the 2026 Draft Payor Guidance revises its suggestion that payors should receive &amp;ldquo;&lt;em&gt;unbiased, factual, accurate, and non-misleading&lt;/em&gt;&amp;rdquo; information about unapproved uses or approved/cleared medical products.[[N:2018 Final Payor Guidance, supra note 4, at 21.]] It replaces this potentially more exacting (and ambiguous) standard with &amp;ldquo;truthful and not misleading.&amp;rdquo; By doing so, FDA aligns the recommendation to the language contained in sections 502(a) (&amp;ldquo;false or misleading&amp;rdquo;) and 502(gg) (&amp;ldquo;truthful and not misleading&amp;rdquo;), and offers a standard that firms well understand in the context of communicating information to consumers and healthcare providers.[[N:See 21 U.S.C. &amp;sect;&amp;sect; 352(a) and (gg).]]&lt;/p&gt;
&lt;p&gt;In another sense, the 2026 Draft Payor Guidance clarifies that the Agency does not intend to use HCEI that is disseminated consistent with the guidance&amp;rsquo;s recommendations, &lt;em&gt;standing alone&lt;/em&gt;, as evidence of a new intended use.[[N:2026 Draft Payor Guidance, supra note 1, at 7.]] The addition of &amp;ldquo;standing alone&amp;rdquo; reveals that FDA recognizes the evolution of First Amendment case law, which has increasingly limited FDA&amp;rsquo;s ability to rely on truthful and non-misleading speech, without more, as evidence of unlawful conduct or as the basis for taking enforcement action.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;.* &amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;Comments to the 2026 Draft Payor Guidance can be submitted to FDA until August 3, 2026.[[N:91 Fed. Reg. 33181, 33181 (June 3, 2026).]] Given the issues discussed in the draft guidance, stakeholders should consider engaging in the comment process to help shape FDA&amp;rsquo;s final approach to firm communications with payors.&lt;/p&gt;
&lt;p&gt;We will continue to monitor FDA developments relating to firm communications with payors and HCEI. If you have any questions about the content discussed or would like more information, please reach out to one of the authors of this Advisory or to your existing Arnold &amp;amp; Porter contacts.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{67425153-CF84-4462-B80A-118B9D369F95}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/algorithmic-pricing-navigating-antitrust-and-consumer-protection-risks</link><a10:author><a10:name>Raqiyyah Pippins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pippins-raqiyyah</a10:uri><a10:email>raqiyyah.pippins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Wilson D. Mudge</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mudge-wilson-d</a10:uri><a10:email>Wilson.Mudge@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Leah J. Harrell</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/harrell-leah-j</a10:uri><a10:email>leah.harrell@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Danait Mengist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mengist-danait</a10:uri><a10:email>danait.mengist@arnoldporter.com</a10:email></a10:author><title>Algorithmic Pricing: Navigating Antitrust and Consumer Protection Risks</title><description>Companies increasingly are turning to artificial intelligence-driven pricing tools to optimize pricing strategies, but regulators and courts are paying closer attention to how those tools use competitor and consumer data. Recent antitrust cases, U.S. Department of Justice enforcement activity, and new state laws are shaping a rapidly evolving legal framework for algorithmic pricing, particularly where algorithms facilitate competitor coordination or enable personalized pricing based on consumer information.</description><pubDate>Wed, 10 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;As artificial intelligence (AI) becomes increasingly available to support business operations, companies may consider incorporating AI-driven tools, such as those used for algorithmic pricing, into their marketing strategies. Algorithmic pricing refers to the use of automated systems or artificial intelligence to determine, recommend, or adjust prices, and spans a wide range of applications, from adjusting prices based on inventory levels or demand patterns to more sophisticated tools that incorporate competitor or consumer data. Before adopting these tools, companies should consider that regulators have intensified their scrutiny of algorithmic pricing across multiple enforcement regimes.&lt;/p&gt;
&lt;p&gt;Recent regulatory and litigation activity has focused on two distinct uses of algorithmic pricing, each raising a different set of potential legal concerns, specifically:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Algorithms that incorporate or share pricing information from multiple competing companies to set or recommend prices&lt;/strong&gt;, which antitrust enforcers have scrutinized as a potential vehicle for coordination among competitors.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Algorithms that set individualized prices based on personal consumer data, often called &amp;ldquo;surveillance&amp;rdquo; or &amp;ldquo;personalized&amp;rdquo; pricing&lt;/strong&gt;, which has become the subject of new state disclosure requirements and substantive restrictions under consumer protection law.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;This Advisory provides an overview of the evolving legal landscape in both areas &amp;mdash; from federal antitrust enforcement and litigation to a growing patchwork of state consumer protection laws &amp;mdash; and offers practical considerations for companies that use, or are considering using, AI-driven pricing tools.&lt;/p&gt;
&lt;h2&gt;Antitrust Considerations&lt;/h2&gt;
&lt;h3&gt;Key Cases&lt;/h3&gt;
&lt;p&gt;The Ninth Circuit&amp;rsquo;s August 2025 decision in &lt;em&gt;Gibson v. Cendyn Group, LLC&lt;/em&gt; is the first federal appellate opinion to address the antitrust implications of algorithmic pricing. The court affirmed dismissal of claims that Las Vegas Strip hotels had violated Section 1 of the Sherman Act by separately licensing a common pricing software.[[N:&lt;em&gt;Gibson v. Cendyn Grp, LLC&lt;/em&gt;, No. 24-3576, 2025 WL 2371948 at *2 (9th Cir. Aug. 15, 2025).]] The court held that competitors&amp;rsquo; independent decisions to use the same software vendor &amp;mdash; without an agreement among themselves to do so or to follow its recommendations &amp;mdash; did not, without more, give rise to antitrust liability, noting that the license agreements at issue did not raise antitrust concerns because they did not restrain any hotel&amp;rsquo;s ability to price its own rooms independently.[[N:Id. at *8-9.]]&lt;/p&gt;
&lt;p&gt;At the same time, the court identified circumstances in which use of a common pricing software could pose competitive concerns, including where competitors agree among themselves to use the software and adhere to its pricing recommendations, or where the software pools and shares confidential pricing information among competitors.[[N:Id. at *1, *7.]]&lt;/p&gt;
&lt;p&gt;The Ninth Circuit&amp;rsquo;s decision in &lt;em&gt;Gibson v. Cendyn&lt;/em&gt; builds on a body of district court decisions that have reached differing outcomes despite similar fact patterns. For example, in 2023, the Middle District of Tennessee allowed the claims to proceed in a multidistrict litigation against RealPage and multi-family building owners and manager clients, but applied a more defendant-friendly rule of reason analysis rather than per se liability because the case did not involve a direct agreement among competitors or a complete delegation of pricing authority to the software.[[N:&lt;em&gt;In re RealPage, Inc., Rental Software Antitrust Litig.&lt;/em&gt; (No. II), 709 F. Supp. 3d 478 (M.D. Tenn. 2023).]] In &lt;em&gt;Duffy v. Yardi&lt;/em&gt; (W.D. Wash., 2024), by contrast, the court held that plaintiffs adequately alleged a &lt;em&gt;per se&lt;/em&gt; unlawful price-fixing agreement where competitors allegedly shared nonpublic information through a common software provider.[[N:&lt;em&gt;Duffy v. Yardi Sys. Inc.&lt;/em&gt;, 758 F. Supp. 3d 1283 (W.D. Wash. 2024).]] Most recently, in &lt;em&gt;Segal v. Amadeus IT Group&lt;/em&gt; (N.D. Ill., 2026), another case involving hotel software, the court again focused on what it found was a lack of alleged agreement among competitors to coordinate their pricing, rather than mere allegations of sharing aggregated and anonymized information, in dismissing plaintiff&amp;rsquo;s third amended complaint.[[N: Id. at 8 (citing &lt;em&gt;In re MultiPlan Health Ins. Provider Litig.&lt;/em&gt;, 789 F. Supp. 3d 614, 641 (N.D. Ill. 2025)).]]&lt;/p&gt;
&lt;p&gt;The U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) filed Statements of Interest in multiple of these private-plaintiff district court cases, arguing among other things that using a pricing algorithm to set benchmark or &amp;ldquo;starting point&amp;rdquo; prices may constitute unlawful concerted action regardless of any differences in final pricing, exchanging pricing information through an algorithm may violate antitrust law in the same way as direct information sharing, and that an invitation proposing collective action, followed by conduct demonstrating acceptance of the invitation &amp;mdash; such as contracting with a common software provider &amp;mdash; can establish an antitrust violation even without a direct agreement among competitors. DOJ also filed an amicus brief before the Ninth Circuit in &lt;em&gt;Gibson&lt;/em&gt;, advancing the same &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/08/antitrust-implications-of-algorithmic-pricing" target="_self"&gt;arguments&lt;/a&gt;.&lt;/p&gt;
&lt;h3&gt;Recent Developments&lt;/h3&gt;
&lt;p&gt;In May 2026, a North Carolina federal court approved a final judgment resolving the DOJ&amp;rsquo;s 2024 civil suit against RealPage, a provider of revenue management software used by multi-family building owners and managers.[[N:Final Judgment, &lt;em&gt;United States v. RealPage, Inc.&lt;/em&gt;, 24-cv-710 (M.D.N.C. May 19, 2026).]] Among other terms, the judgment requires RealPage to cease using nonpublic data from competing properties in the &amp;ldquo;runtime&amp;rdquo; operation of its products, refrain from sharing competitively sensitive information (CSI) among users, modify certain product features (including auto-accept functionality), implement an antitrust compliance program, and submit to a three-year independent compliance monitor.[[N:Id. at IV-V, VII.]] The settlement allows RealPage to continue using CSI that is at least 12 months old to train its algorithm.[[N:Id. at IV.A.4.]] RealPage did not admit any wrongdoing as part of the settlement.&lt;/p&gt;
&lt;p&gt;While DOJ has yet to bring a criminal antitrust case based on algorithmic pricing software, Acting Deputy Assistant Attorney General Daniel Glad recently stated that criminal antitrust liability can arise where competitors knowingly agree to use software that relies on their nonpublic data to set prices, observing that such an arrangement could supply the elements of a potentially criminal &lt;em&gt;per se&lt;/em&gt; antitrust violation. He noted that the distinction turns on whether competitors have agreed to share nonpublic information with the understanding that it will be used to set prices for other competitors.[[N:&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/acting-deputy-assistant-attorney-general-criminal-enforcement-daniel-gladd-delivers" target="_blank"&gt;Acting Deputy Assistant Attorney General for Criminal Enforcement Daniel Glad Delivers Remarks at the Antitrust West Coast Conference&lt;/a&gt;, May 14, 2026.]]&lt;/p&gt;
&lt;h3&gt;State and Municipal Measures&lt;/h3&gt;
&lt;p&gt;In 2025, two states &amp;mdash; California[[N:A. 325 2025-2026 Leg. (Cal.).]] and New York[[N:N.Y. Gen. Bus. Law. &amp;sect; 340-B.]] &amp;mdash; passed statutes governing the use of algorithmic pricing software. The primary California antitrust law is the Cartwright Act, which is generally consistent with Section 1 of the federal Sherman Act. On October 6, 2025, Governor Gavin Newsom signed Assembly Bill 325, amending the Cartwright Act to make it unlawful to (1) use or distribute a common pricing algorithm as part of a contract, combination in the form of a trust, or conspiracy to restrain trade or commerce and (2) use or distribute a common pricing algorithm if the person coerces another person to set or adopt a recommended price or commercial term recommended by the common pricing algorithm.[[N:A. 325 2025-2026 Leg. (Cal.).]] The act applies to all industries that operate in California.&lt;/p&gt;
&lt;p&gt;In contrast to California&amp;rsquo;s approach, New York&amp;rsquo;s law is specifically focused on the residential rental industry. The law prohibits the use of algorithms to set rental rates, making it unlawful to &amp;ldquo;set or adjust rental prices, lease renewal terms, occupancy levels, or other lease terms and conditions &amp;hellip; based on recommendations from a software, data analytics service, or algorithmic device performing a coordinating function.&amp;rdquo;[[N:N.Y. Gen. Bus. Law. &amp;sect; 340-B.]] Between 2024 and 2025, multiple municipalities also &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/10/algorithmic-pricing-bans-go-coast-to-coast" target="_self"&gt;passed ordinances&lt;/a&gt; to prohibit the use of algorithms in setting rents. &lt;/p&gt;
&lt;h2&gt;Consumer Protection Considerations&lt;/h2&gt;
&lt;p&gt;On the consumer protection side, state legislatures and attorneys general have increasingly focused on &amp;ldquo;surveillance pricing&amp;rdquo; or &amp;ldquo;personalized pricing&amp;rdquo; as a key enforcement priority. Much of the activity to date has centered on grocery retail and online food delivery industries. In May 2026, for example, a bipartisan coalition of state attorneys general submitted &lt;a rel="noopener noreferrer" href="https://ncdoj.gov/wp-content/uploads/2026/05/State-AG-Comment-Letter-re-FTC-ANPRM.pdf" target="_blank"&gt;comments&lt;/a&gt; to the FTC in connection with its rulemaking on fees in online food delivery services, urging the agency to require disclosure of personalized pricing.&lt;/p&gt;
&lt;p&gt;States have taken varying approaches to address their concerns regarding algorithmic pricing, ranging from disclosure requirements to outright bans. New York and Maryland recently became the first states to enact laws directly addressing personalized pricing, with their respective approaches reflecting that spectrum. New York requires businesses to disclose their use of personalized pricing, while Maryland, though limited to the food sector, goes further by prohibiting covered retailers and delivery platforms from setting individualized prices based on consumer data. We have outlined the key requirements for both laws below. Notably, as New York&amp;rsquo;s disclosure law illustrates, states&amp;rsquo; scrutiny is not necessarily confined to any single sector and may extend to consumer-facing businesses generally.&lt;/p&gt;
&lt;h3&gt;New York&amp;rsquo;s Algorithmic Pricing Disclosure Act&lt;/h3&gt;
&lt;p&gt;Applying a transparency-based approach, New York&amp;rsquo;s Algorithmic Pricing Disclosure Act requires any business in the state that uses a consumer&amp;rsquo;s personal data to set an algorithmic price to display, alongside that price, a clear and conspicuous statement that &amp;ldquo;THIS PRICE WAS SET BY AN ALGORITHM USING YOUR PERSONAL DATA.&amp;rdquo;[[N:N.Y. Gen. Bus. Law &amp;sect; 349-a(2). The Act defines &amp;ldquo;personalized algorithmic pricing&amp;rdquo; as &amp;ldquo;dynamic pricing set by an algorithm that uses personal data.&amp;rdquo; Id. &amp;sect; 349-a(1)(f).]] The law applies across industries and defines &amp;ldquo;personal data&amp;rdquo; broadly to include &amp;ldquo;any data that identifies or could reasonably be linked, directly or indirectly, with a specific consumer or device.&amp;rdquo;[[N:The act includes limited exceptions, including for insurers, financial institutions subject to the Gramm-Leach-Bliley Act, and certain below-contract pricing offered to existing subscription customers. Id. &amp;sect; 349-a(3).]] The law took effect on November 10, 2025, after surviving a First Amendment challenge brought by the National Retail Federation, with the court rejecting the argument that the mandated disclosure was unconstitutional compelled speech.[[N:&lt;em&gt;Nat&amp;rsquo;l Retail Fed&amp;rsquo;n v. James&lt;/em&gt;, No. 1:25-cv-05500-JSR (S.D.N.Y. Oct. 8, 2025) (granting motion to dismiss). The court applied the deferential standard of &lt;em&gt;Zauderer v. Office of Disciplinary Counsel&lt;/em&gt;, 471 U.S. 626 (1985), and found the required disclosure factual and uncontroversial. The decision is on appeal to the Second Circuit (No. 25-2818).]] Enforcement rests with the New York Attorney General, who must allow an opportunity to cure before pursuing civil penalties of up to $1,000 per violation; there is no private right of action.[[N:N.Y. Gen. Bus. Law &amp;sect; 349-a(4) (providing that, after a business continues to violate the Act following a cease-and-desist letter, the Attorney General may seek injunctive relief and a civil penalty of up to $1,000 per violation, without proof of consumer injury).]]&lt;/p&gt;
&lt;p&gt;While she has yet to take any formal enforcement actions under the law, the Attorney General&amp;rsquo;s recent inquiry into Instacart shows what compliance will be measured against in practice. After a December 2025 study reported that shoppers were quoted prices as much as 23% higher for the same items, the Attorney General issued a demand letter to Instacart questioning its compliance with the newly enacted law. In particular, the Attorney General took the position that a disclosure buried in linked fine print &amp;mdash; and missing from the pages where prices actually appeared &amp;mdash; did not meet the law&amp;rsquo;s &amp;ldquo;clear and conspicuous&amp;rdquo; standard.[[N:Letter from Ryan D. Galisewski, Assistant Att&amp;rsquo;y Gen., N.Y. State Office of the Att&amp;rsquo;y Gen., to Chris Rogers &amp;amp; Morgan Fong, Maplebear Inc. d/b/a Instacart (Jan. 8, 2026); see also Press Release, N.Y. State Att&amp;rsquo;y Gen., Attorney General James Demands Answers from Instacart About Algorithmic Pricing (Jan. 8, 2026).]]&lt;/p&gt;
&lt;p&gt;Notably, while New York&amp;rsquo;s law stops at disclosure, the state has introduced legislation that would go further and ban &amp;ldquo;surveillance pricing&amp;rdquo; outright, a reminder that today&amp;rsquo;s disclosure regime may be a floor rather than a ceiling.[[N:See S.8623-B, 2025-2026 Reg. Sess. (N.Y.) (proposing to amend &amp;sect; 349-a to prohibit &amp;ldquo;surveillance pricing&amp;rdquo;); see also Press Release, N.Y. State Att&amp;rsquo;y Gen., Attorney General James Calls for Passage of Legislation to Protect New Yorkers from Predatory Pricing Schemes, (Mar. 16, 2026) (announcing the &amp;ldquo;One Fair Price&amp;rdquo; legislative package).]]&lt;/p&gt;
&lt;h3&gt;Maryland&amp;rsquo;s Protection From Predatory Pricing Act&lt;/h3&gt;
&lt;p&gt;Maryland has gone further than disclosure. Its Protection from Predatory Pricing Act (HB 895), signed in April 2026 and effective October 1, 2026, makes Maryland the first state to prohibit &amp;mdash; rather than merely require disclosure of &amp;mdash; personalized pricing, though only in the grocery sector.[[N:&lt;a rel="noopener noreferrer" href="https://mgaleg.maryland.gov/mgawebsite/Legislation/Details/HB0895?ys=2026RS" target="_blank"&gt;Md. H.B. 895, 2026 Reg. Sess.&lt;/a&gt; (enacted Apr. 28, 2026) (ch. 154).]] The act bars large food retailers (grocery-style establishments of at least 15,000 square feet) and third-party food delivery providers from using &amp;ldquo;dynamic pricing&amp;rdquo; &amp;mdash; defined as setting a price specific to an individual consumer based on that consumer&amp;rsquo;s personal data &amp;mdash; to charge higher prices. It separately prohibits covered businesses from using &amp;ldquo;protected class data,&amp;rdquo; such as race or gender, in a way that denies a consumer a good, service, or advantage. The act carves out ordinary commercial practices, including loyalty programs, promotional discounts, and price differences attributable to objective costs like shipping or taxes. As with New York, enforcement sits exclusively with the state Attorney General rather than private plaintiffs, though Maryland&amp;rsquo;s law carries steeper civil penalties of up to $10,000 per violation, with more for repeat offenders.&lt;/p&gt;
&lt;p&gt;Beyond New York and Maryland, algorithmic pricing continues to attract attention from lawmakers in other states and at the federal level. Connecticut has since become the third state to act, enacting an omnibus privacy law &amp;mdash; effective October 1, 2026 &amp;mdash; that employs a hybrid approach pairing a New York-style disclosure requirement with a prohibition on &amp;ldquo;surveillance pricing&amp;rdquo; by retail sellers and third-party food delivery services.[[N:Conn. Pub. Act No. 26-64, &amp;sect; 11 (2026).]] A number of other states appear poised to follow, with the legislatures in Illinois and California considering outright bans on &amp;ldquo;surveillance pricing.&amp;rdquo;[[N: Ill. H.B. 4248, 104th Gen. Assemb. (2026) (as amended, would prohibit surveillance pricing; passed both chambers and pending House concurrence); Cal. A.B. 2564, 2025-2026 Reg. Sess. (Cal.).]] Federal lawmakers have also begun to engage on this issue, introducing the Stop Price Gouging in Grocery Stores Act of 2026, which would bar surveillance-based pricing in food stores.[[N:Stop Price Gouging in Grocery Stores Act of 2026, S. 3892, 119th Cong. (2026); see also H.R. 4966, 119th Cong. (2025).]] Additionally, members of the House Oversight Committee and Energy and Commerce Committee have launched separate investigations requesting information from companies regarding their surveillance pricing practices and use of personal data to set individualized prices.[[N:House Oversight Committee, &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Foversight.house.gov%2Frelease%2Fcomer-investigates-use-of-artificial-intelligence-to-set-prices-for-consumers%2F&amp;amp;data=05%7C02%7CTheresa.Denson%40arnoldporter.com%7Cde009b8002ae4113b36508dec6389e79%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639166143649213479%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=dS7X%2FBSgKJ6kvZ3gbZN6j8FRjk%2FoyVKrOhk4Z4JJmBY%3D&amp;amp;reserved=0" target="_blank"&gt;Comer Investigates Use of Artificial Intelligence to Set Prices for Consumers&lt;/a&gt; (Mar. 5, 2026); Energy and Commerce Committee, &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpallone.house.gov%2Fmedia%2Fpress-releases%2Fpallone-launches-surveillance-pricing-inquiry&amp;amp;data=05%7C02%7CTheresa.Denson%40arnoldporter.com%7Cde009b8002ae4113b36508dec6389e79%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639166143649246768%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=KjYHFn7b93S5m1%2FW%2F94xQEx7VLsyqH1woItlnXpj0NM%3D&amp;amp;reserved=0" target="_blank"&gt;Pallone Launches Surveillance Pricing Inquiry&lt;/a&gt; (May 13, 2026).]]&lt;/p&gt;
&lt;h2&gt;Key Takeaways&lt;/h2&gt;
&lt;p&gt;Across both the antitrust and consumer protection contexts, the regulatory and enforcement landscape for algorithmic pricing is developing quickly and may vary by jurisdiction and industry. Companies that use, or are considering using, algorithmic or AI-driven pricing tools may wish to keep the following considerations in mind:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Understand the tools and their inputs&lt;/strong&gt;. Companies should understand how any pricing tool works, what data it relies on (including any competitor or consumer data), and how its pricing recommendations are used, so they can assess the tool against the applicable legal frameworks. Vendor agreements should describe these matters in writing.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Retain meaningful control over pricing&lt;/strong&gt;. Courts and enforcers have distinguished tools that merely recommend prices, subject to user discretion, from arrangements that delegate pricing authority or constrain the user&amp;rsquo;s ability to set prices independently. Avoid communications with competitors about the use of pricing software.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Evaluate disclosure obligations for personalized pricing&lt;/strong&gt;. Where pricing relies on consumers&amp;rsquo; personal data, companies should evaluate whether disclosure requirements such as New York&amp;rsquo;s or Connecticut&amp;rsquo;s apply and, if so, ensure that any disclosures are clear, conspicuous, and presented where consumers encounter the relevant prices.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Monitor developments and seek counsel&lt;/strong&gt;. Given the pace of legislative and enforcement activity across jurisdictions (including bans of certain strategies, such as the ban on dynamic grocery pricing in Maryland), companies should monitor developments in the regions where they operate and consult antitrust and consumer protection counsel before deploying new pricing tools.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Arnold &amp;amp; Porter regularly advises companies on their pricing practices and disputes relating to them. Our &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/antitrust-competition" target="_self"&gt;Antitrust/Competition&lt;/a&gt; and &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/consumer-protection-and-advertising" target="_self"&gt;Consumer Protection &amp;amp; Advertising&lt;/a&gt; practices would be happy to assist with any questions you have regarding compliance with algorithmic pricing laws.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{98D6524D-C816-4803-84B4-F9501A5B097C}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/eu-uk-medical-device-ivd-bootcamp</link><title>EU/UK Medical Device &amp; IVD Bootcamp</title><description>Join us on Tuesday, 9 June 2026 for a full day bootcamp into the world of medical devices and IVDs! We will discuss the details you need to know, the current EU and UK regulatory landscape, and hot topics.</description><pubDate>Tue, 09 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter's Life Sciences Future Forum invites you to a complimentary, in-person, full-day bootcamp into the world of medical devices and IVDs!&lt;/p&gt;
&lt;p&gt;We will discuss the details you need to know, the current EU and UK regulatory landscape, along with hot topics, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The current status of the EU MDR and IVDR and the Commission&amp;rsquo;s proposals to overhaul the regime&lt;/li&gt;
    &lt;li&gt;The current status of the overhaul to the UK regime and what&amp;rsquo;s to come&lt;/li&gt;
    &lt;li&gt;Classification, technical file and QMS requirements&lt;/li&gt;
    &lt;li&gt;The current position in relation to software medical devices and AI&lt;/li&gt;
    &lt;li&gt;The role of economic operators in your supply chain and considerations relating to your physical and contractual supply&lt;/li&gt;
    &lt;li&gt; When an assay is classed as an IVD and the LDT exemption&lt;/li&gt;
    &lt;li&gt;Rules on the use of devices/IVDs in EU and/or UK clinical trials&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;And much more! Expect presentations and panel discussions from both Arnold &amp;amp; Porter lawyers and external speakers from industry associations such as MedTech Europe, and notified bodies such as BSI. Including time for networking over breaks, lunch, and a drinks reception.&lt;/p&gt;
&lt;h2&gt;Participation:&lt;/h2&gt;
&lt;p&gt;The Arnold &amp;amp; Porter Life Sciences Future Forum is a group established to provide training and networking opportunities for in-house junior and mid-level lawyers in the life sciences industry. However, all seniorities are welcome. There are no formal entry or membership requirements &amp;mdash; please feel free to pass this to colleagues who might be interested in attending.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{FF256046-7BB4-4FB3-BB5E-399838EC5CAF}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/06/lawcom-international-quotes-kathleen-harris-on-evolving-drivers-of-white-collar-investigations</link><title>Law.com International Quotes Kathleen Harris on Evolving Drivers of White Collar Investigations</title><description>Arnold &amp;amp; Porter partner Kathleen Harris, who heads firm&amp;rsquo;s London office, was quoted in the &lt;em&gt;Law.com International&lt;/em&gt; article, &amp;ldquo;How Speak-Up Culture is Keeping White Collar Teams Busy,&amp;rdquo; discussing changes in the UK investigations landscape.</description><pubDate>Tue, 09 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Kathleen Harris, who heads firm&amp;rsquo;s London office, was quoted in the &lt;em&gt;Law.com International&lt;/em&gt; article, &amp;ldquo;How Speak-Up Culture is Keeping White Collar Teams Busy,&amp;rdquo; discussing changes in the UK investigations landscape.&lt;/p&gt;
&lt;p&gt;Kathleen noted that the Serious Fraud Office (SFO) has &amp;ldquo;quite clearly&amp;rdquo; focused in recent years on pursuing fraud cases involving &amp;ldquo;domestic harm,&amp;rdquo; leading some market participants to conclude that the agency was less focused on &amp;ldquo;global offending&amp;rdquo; and more focused on matters perceived by the public as high-profile fraud.&lt;/p&gt;
&lt;p&gt;Kathleen also observed that white collar practices have adapted to changing client needs, explaining that firms are now focused on a broader range of investigations because &amp;ldquo;what has developed is more cultural investigations: cultural, behaviour investigations.&amp;rdquo; She further noted that increasing compliance expectations, accountability standards, and legislative developments, including the Economic Crime and Corporate Transparency Act, are generating additional investigative and advisory work as companies seek to &amp;ldquo;sense check&amp;rdquo; their compliance programs and evaluate potential concerns. Kathleen added that she expects continued scrutiny of corporate wrongdoing and does not believe that focus &amp;ldquo;is going away.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law.com/international-edition/2026/06/03/how-speak-up-culture-is-keeping-white-collar-teams-busy/" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F6B01107-F92A-468C-810C-ECFDEC7DC6E2}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/06/law360-quotes-joel-dahlquist-on-investment-treaty-claims-challenging-russia-sanctions</link><title>Law360 Quotes Joel Dahlquist on Investment Treaty Claims Challenging Russia Sanctions</title><description>&lt;p&gt;Arnold &amp;amp; Porter International Arbitration Adviser Joel Dahlquist was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Claims Over Russia Sanctions Test Investment Treaty Limits,&amp;rdquo; which examines a growing wave of investor-state arbitration claims brought by sanctioned Russian individuals and entities against European countries that imposed sanctions following Russia&amp;rsquo;s invasion of Ukraine.&lt;/p&gt;</description><pubDate>Tue, 09 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter International Arbitration Adviser Joel Dahlquist was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Claims Over Russia Sanctions Test Investment Treaty Limits,&amp;rdquo; which examines a growing wave of investor-state arbitration claims brought by sanctioned Russian individuals and entities against European countries that imposed sanctions following Russia&amp;rsquo;s invasion of Ukraine.&lt;/p&gt;
&lt;p&gt;Discussing whether bilateral investment treaty (BIT) drafters anticipated such claims, Joel noted that most investment treaties were negotiated during the post-Cold War period and were designed to promote foreign investment rather than address modern sanctions disputes. &amp;ldquo;No, I think, is the short answer to the question as to whether treaty drafters ever envisioned this happening, at least not in the contemporary sense,&amp;rdquo; he said, adding that he has &amp;ldquo;a very hard time seeing that this ever was something that they contemplated when the vast majority of these treaties were signed.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Addressing how arbitral tribunals may approach these cases, Joel explained that the central issue is unlikely to be whether sanctions themselves were justified. &amp;ldquo;The question is not really, was the state right in doing this?&amp;rdquo; he said. Instead, he suggested that tribunals are more likely to focus on procedural protections and due process considerations, which are likely to become the key battleground in sanctions-related investment treaty disputes.&lt;/p&gt;
&lt;p&gt;&lt;a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.law360.com%2Farticles%2F2485493%2Fclaims-over-russia-sanctions-test-investment-treaty-limits&amp;amp;data=05%7C02%7CDerek.Parsons%40arnoldporter.com%7Ce61a9b370c114898056608dec5f07fce%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639165833910658895%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=B4USp%2FQfg3QTSGjp%2BNbBasJvzFbDH3SqGBIIMxQ%2BwIY%3D&amp;amp;reserved=0"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{3B019E26-15D7-40C7-90FF-EE4CC4A2C267}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/recent-developments-in-cross-border-restructuring-under-chapter-15-of-the-bankruptcy-code</link><a10:author><a10:name>Benjamin Mintz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mintz-benjamin</a10:uri><a10:email>benjamin.mintz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Justin Imperato</a10:name><a10:uri>https://www.arnoldporter.com/en/people/i/imperato-justin</a10:uri><a10:email>justin.imperato@arnoldporter.com</a10:email></a10:author><title>Recent Developments in Cross-Border Restructuring Under Chapter 15 of the Bankruptcy Code</title><description>As cross-border restructurings become increasingly common, recognition of foreign insolvency proceedings under Chapter 15 of the U.S. Bankruptcy Code has become a critical tool for protecting assets, binding U.S.-based creditors, and coordinating multinational restructurings. Recent bankruptcy court decisions highlight evolving issues surrounding Chapter 15 recognition, including the treatment of cannabis-related restructurings, the determination of a debtor&amp;rsquo;s center of main interests (COMI), and the requirement that a debtor have property in the United States to obtain recognition.</description><pubDate>Tue, 09 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;Multi-national companies continue to grow and expand their global networks, with subsidiaries, assets, creditors, and contracts spanning across multiple jurisdictions, and the need for a coherent legal process to coordinate insolvency proceedings across borders has grown correspondingly. A restructuring that might once have involved assets and creditors concentrated in one or two countries now routinely implicates a dozen or more jurisdictions simultaneously. One of those jurisdictions very often includes the U.S. Indeed, the rise of sophisticated international capital markets means that foreign companies frequently have U.S.-law-governed debt, U.S.-based bondholders, or assets held through U.S. entities.&lt;/p&gt;
&lt;p&gt;Many distressed multi-national companies with ties to the U.S., however, now elect to restructure in jurisdictions other than the U.S.[[N:English schemes of arrangement, Canadian Companies&amp;rsquo; Creditors Arrangement Act (CCAA) proceedings, and other foreign restructuring tools have gained prominence as vehicles for binding dissenting creditors.]] to take advantage of tools that are not available under the U.S. Bankruptcy Code (e.g., non-consensual third-party releases, reverse vesting orders[[N:See Benjamin Mintz and Justin Imperato, &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/05/time-to-learn-the-canadian-two-step" target="_self"&gt;Time to Learn the Canadian Two-Step?&lt;/a&gt; (May 26, 2026).]]). As a result, recognition of those foreign proceedings in the U.S. under Chapter 15 of the Bankruptcy Code has become the essential mechanism for giving foreign plan confirmations and other orders from foreign proceedings legal effect in the U.S. to bind the foreign debtor&amp;rsquo;s U.S.-based creditors and protect its U.S.-based assets. With all that may be at stake for entities engaged in cross-border restructurings and so much of their success potentially dependent on recognition under Chapter 15, in this article, we discuss three noteworthy decisions from various U.S. bankruptcy courts that address whether to recognize the foreign insolvency proceeding of a cannabis company, when Chapter 15 relief may not be available because the foreign proceeding is not in a jurisdiction from which the debtor has its center of main interests or an establishment, and whether Chapter 15 debtors must have U.S.-based assets as of the Chapter 15 petition date. First, though, we briefly delve into the standards for recognition under Chapter 15 and discuss the beneficial consequences of recognition.&lt;/p&gt;
&lt;h2&gt;Recognition Standards Under Chapter 15 and the Beneficial Consequences of Recognition&lt;/h2&gt;
&lt;p&gt;Chapter 15 of the Bankruptcy Code governs cross-border insolvency cases, and recognition under it, either as a &amp;ldquo;foreign main proceeding&amp;rdquo; or as a &amp;ldquo;foreign non-main proceeding,&amp;rdquo; is significant for several reasons.[[N:See 11 U.S.C. &amp;sect;1517 (allowing a U.S. bankruptcy court to recognize a foreign insolvency proceeding as either a &amp;ldquo;main&amp;rdquo; or &amp;ldquo;non-main&amp;rdquo; proceeding, assuming certain statutory requirements have been met).]] The Bankruptcy Code provides that a foreign main proceeding is &amp;ldquo;a foreign proceeding pending in the country where the debtor has the center of its main interests [(COMI)].&amp;rdquo;[[N:11 U.S.C. &amp;sect; 1502(4).]] &amp;ldquo;In the absence of evidence to the contrary, the debtor&amp;rsquo;s registered office, or habitual residence in the case of an individual, is presumed to be the center of the debtor&amp;rsquo;s main interest,&amp;rdquo;[[N:11 U.S.C. &amp;sect; 1516(c). This presumption may be rebutted by evidence to the contrary. See I&lt;em&gt;n re Tri-Continental Exch. Ltd.&lt;/em&gt;, 349 B.R. 627, 634 (Bankr. E.D. Cal. 2006).]] and COMI generally should be determined based on the debtor&amp;rsquo;s activities as of the Chapter 15 petition date.[[N:See &lt;em&gt;Morning Mist Holdings Ltd. v. Krys (In re Fairfield Sentry Ltd.&lt;/em&gt;), 714 F.3d 127, 137 (2d Cir. 2013). A court may consider the period prior to commencement of the Chapter 15 case to ensure the debtor has not manipulated its COMI in bad faith. See id.]]&lt;/p&gt;
&lt;p&gt;When a debtor&amp;rsquo;s foreign proceeding is granted recognition as a foreign main proceeding, it triggers an automatic stay that halts virtually all U.S. litigation and enforcement actions against the debtor and its U.S.-based assets, including attempts to transfer or seize those assets. Recognition is also material because it grants the debtor&amp;rsquo;s foreign representative legal standing to operate in U.S. courts, allowing the representative to gather evidence, pursue claims, and administer assets located in the U.S. that may otherwise be inaccessible.&lt;/p&gt;
&lt;p&gt;The Bankruptcy Code further provides that a foreign non-main proceeding is &amp;ldquo;a foreign proceeding, other than a foreign main proceeding, pending in a country where the debtor has an establishment.&amp;rdquo;[[N:11 U.S.C. &amp;sect; 1502(5).]] An &amp;ldquo;establishment&amp;rdquo; means &amp;ldquo;any place of operations where the debtor carries out nontransitory economic activity,&amp;rdquo;[[N:11 U.S.C. &amp;sect; 1502(2).]] and courts generally analyze whether a debtor has an establishment in the jurisdiction in which the foreign proceeding is pending as of the Chapter 15 petition date.[[N:&lt;em&gt;Rozhkov v. Pirogova (In re Pirogova)&lt;/em&gt;, 612 B.R. 475, 483 (S.D.N.Y. 2020).]]&lt;/p&gt;
&lt;p&gt;Recognition as a foreign non-main proceeding under Chapter 15 carries less automatic force than recognition as a foreign main proceeding. In foreign non-main proceedings, U.S. bankruptcy courts appoint foreign representatives who are granted standing to appear and be heard in U.S. courts and the ability to seek tailored injunctive relief to protect the debtor&amp;rsquo;s U.S. assets. Unlike main proceeding recognition, non-main recognition does not trigger an automatic stay. Instead, any such relief is discretionary, meaning the foreign representative must affirmatively petition the U.S. bankruptcy court for protective measures, and the court weighs whether granting such relief would appropriately protect the interests of creditors and other interested parties.&lt;/p&gt;
&lt;p&gt;Of course, courts may determine that foreign restructurings do not qualify as &amp;ldquo;foreign proceedings&amp;rdquo; under Bankruptcy Code section 101(23)[[N:The Bankruptcy Code defines a &amp;ldquo;foreign proceeding&amp;rdquo; as &amp;ldquo;a collective judicial or administrative proceeding in a foreign country &amp;hellip; under a law relating to insolvency or adjustment of debt in which proceeding the assets and affairs of the debtor are subject to control or supervision by a foreign court, for the purpose of reorganization or liquidation.&amp;rdquo; 11 U.S.C. &amp;sect; 101(23).]] or entirely decline to recognize a foreign proceeding as either main or non-main because the debtor has not adequately demonstrated that its foreign proceeding is pending where the debtor has its COMI or an establishment or where the debtor does not adequately demonstrate that it has property in the U.S. as of the Chapter 15 petition date.[[N:Bankruptcy Code section 109(a) provides that &amp;ldquo;only a person that resides or has a domicile, a place of business, or property in the United States, or a municipality, may be a debtor under &amp;#91;the Bankruptcy Code&amp;#93;.&amp;rdquo; 11 U.S.C. &amp;sect; 109(a). Courts are split over whether the satisfaction of this requirement is a precondition to recognition under Chapter 15. &lt;em&gt;Compare In re Barnet&lt;/em&gt;, 737 F.3d 238 (2d Cir. 2013) (holding the satisfaction of section 109(a) is a precondition to Chapter 15 recognition) and &lt;em&gt;In re Siu-Fung Ceramics Holdings Limited&lt;/em&gt;, No. 24-33299, 2026 WL 382424, at *19 (Bankr. S.D. Feb. 10, 2026) (same) with &lt;em&gt;In re Al Zawawi&lt;/em&gt;, 97 F.4th 1244, 1252-53 (11th Cir. 2024) (holding that satisfaction of section 109(a) was not a condition to Chapter 15 relief). One of the cases part of this split was decided recently and is discussed further below.]] Conversely, even if all the statutory requirements for recognition, either as a main or non-main proceeding, have been satisfied, courts may still decline to recognize foreign proceedings where the results from doing so would be &amp;ldquo;manifestly contrary to the public policy of the United States.&amp;rdquo;[[N:11 U.S.C. &amp;sect; 1506.]]&lt;/p&gt;
&lt;h2&gt;Recent Chapter 15 Recognition Decisions&lt;/h2&gt;
&lt;p&gt;Recently, three U.S. bankruptcy courts have issued key decisions on petitions for recognition under Chapter 15 that may have go-forward impact on cross-border restructurings. We discuss those decisions below.&lt;/p&gt;
&lt;h3&gt;&lt;em&gt;In re The Cannabist Company Holdings, Inc.&lt;/em&gt;[[N:Case No. 26-10426 (BLS), ECF No. 82 (Bankr. D. Del. May 9, 2026).]]&lt;/h3&gt;
&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;This decision is significant for two reasons: first, it demonstrates that distressed cannabis companies may potentially access U.S. bankruptcy protections by routing their restructurings through foreign jurisdictions with more relaxed approaches to cannabis; and second, it reflects growing federal tolerance toward extending legal protections to cannabis-related enterprises. The Cannabist Company Holdings Inc. (Cannabist Holdings) is a Canadian holding company that indirectly owns and operates legal cannabis businesses across eight U.S. states where medical or adult-use marijuana is legally permitted.[[N:The U.S. operating entities are not debtors in Canada or in the U.S.]] To help fund operations, Cannabist Holdings and its Canadian affiliate, The Cannabist Company Holdings (Canada) Inc. (Cannabist Canada and together with Cannabist Holdings, Cannabist), borrowed approximately $180 million by issuing bonds governed by Canadian law. Cannabist subsequently ran into economic trouble due to increased competition, supply chain problems, and difficulty borrowing and raising more money. In January 2026, Cannabist missed a payment due on those bonds and, in response, started selling off parts of the business and winding down others. To carry out those remaining sales in an orderly way with legal protection, Cannabist filed for insolvency in Canada under the CCAA.&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Cannabist&amp;rsquo;s foreign representative then petitioned the Bankruptcy Court for the District of Delaware to recognize that Canadian proceeding, and asked the court to apply the Bankruptcy Code automatic stay protections to Cannabist&amp;rsquo;s non-debtor U.S. subsidiaries and their assets. Such relief, according to the foreign representative, was &amp;ldquo;practically necessary to ensure the uninterrupted operation of the Debtors&amp;rsquo; business and protect the value of the Debtors&amp;rsquo; subsidiaries, [to] maximize value for the Debtors&amp;rsquo; stakeholders, who have claims against the Debtors and their subsidiaries.&amp;rdquo;[[N:Case No. 26-10426 (BLS), ECF No. 76 at &amp;para; 8 (Bankr. D. Del. May 8, 2026).]]&lt;/p&gt;
&lt;p&gt;A creditor of certain non-debtor U.S. subsidiaries objected to Cannabist&amp;rsquo;s Chapter 15 petition, arguing that: (a) section 1506 of the Bankruptcy Code bars recognition because the enterprise&amp;rsquo;s underlying cannabis cultivation, manufacturing, and sales activities contravene U.S. federal law, specifically the Controlled Substances Act; and (b) the automatic stay under section 362(a) of the Bankruptcy Code should not apply to non-debtors, i.e., Cannabist&amp;rsquo;s non-debtor U.S. subsidiaries, or property owned by non-debtors. Notably, the U.S. Trustee did not file a written objection to Cannabist&amp;rsquo;s Chapter 15 petition for any reason, including its ties to the cannabis industry. This was a departure from the U.S. Trustee&amp;rsquo;s approach in prior cannabis-related bankruptcy matters.[[N:See, e.g., &lt;em&gt;In re Arenas&lt;/em&gt;, 514 B.R. 887 (Bankr. D. Colo. 2014), &lt;em&gt;aff&amp;rsquo;d&lt;/em&gt; 535 B.R. 845 (B.A.P. 10th Cir. 2015) (dismissing the case on the U.S. Trustee&amp;rsquo;s motion because the case would be funded by profits of an ongoing criminal activity).]]&lt;/p&gt;
&lt;p&gt;Cannabist&amp;rsquo;s foreign representative and the objecting creditor appear to have settled the dispute, submitting a proposed order granting recognition that did not alter the proposed injunction with respect to Cannabist&amp;rsquo;s non-debtor U.S. subsidiaries, but it did include a narrowly tailored reservation of rights allowing the objecting creditor to resume litigating its objection, with any resulting ruling limited so as not to affect recognition as to any other parties. The court ultimately entered the order granting recognition, but it did not issue a memorandum decision explaining its reasoning. The court&amp;rsquo;s entry of the recognition order, along with broader rescheduling of cannabis as a controlled substance,[[N:On April 23, 2026, the Drug Enforcement Agency (DEA) down-scheduled from Schedule I to Schedule III two categories of marijuana under the Controlled Substances Act: (1) marijuana contained in a U.S. Food and Drug Administration-approved drug product; and (2) marijuana subject to a state medical marijuana license. Notice was also given of an expedited DEA hearing that will be held this summer to consider whether marijuana more broadly (including recreational marijuana) should be down-scheduled through a formal rulemaking process.]] potentially signals greater acceptance from federal bodies concerning these substances.&lt;/p&gt;
&lt;p&gt;Indeed, U.S. cannabis companies have historically had difficulty employing Chapters 7 and 11 of the Bankruptcy Code to restructure, given that cannabis is still illegal under U.S. federal law and U.S. bankruptcy courts may not administer illegal enterprises.[[N:See, e.g., &lt;em&gt;In re Way to Grow, Inc.&lt;/em&gt;, 597 B.R. 111 (Bankr. D. Colo. 2018), &lt;em&gt;aff'&amp;rsquo;d&lt;/em&gt;, 610 B.R. 338 (D. Colo. 2019) (dismissing the Chapter 11 case of a supplier of equipment to marijuana businesses); &lt;em&gt;In re Rent-Rite Super Kegs West, Ltd.&lt;/em&gt;, 484 B.R. 799 (Bankr. D. Colo. 2012) (dismissing the Chapter 11 case of a landlord-debtor that leased warehouse space to a tenant whose business involved growing marijuana).]] This decision demonstrates that by routing the bankruptcy through Canada and only asking the court to recognize the Canadian case, rather than actually administering the cannabis business itself, Cannabist may have sidestepped that problem. Undoubtedly, the lack of a live objection by parties in interest, including the U.S. Trustee, informed the court&amp;rsquo;s willingness to grant relief. Perhaps crucially to the court, the two entities that actually filed Chapter 15 petitions were holding companies only, meaning neither held cannabis licenses nor directly touched cannabis operations. That distinction may have mattered because it meant the U.S. bankruptcy court did not have to directly oversee an ongoing cannabis business or deal with assets that are still federally prohibited. Instead, the court could simply extend the Canadian court&amp;rsquo;s protections to cover the company&amp;rsquo;s non-debtor U.S. subsidiaries and assets without getting entangled in the federal illegality question.&lt;/p&gt;
&lt;h3&gt;&lt;em&gt;In re Alexander Zheleznyak&lt;/em&gt;[[N:Case No. 26-10554-EDK, ECF No. 42 (Bankr. D. Mass. May 8, 2026).]]&lt;/h3&gt;
&lt;p&gt;This decision underscores that, in some instances, Chapter 15 recognition may be unavailable because the foreign proceeding at issue does not amount to either a main or non-main proceeding. Alexander Zheleznyak is a Russian-Israeli citizen and former co-founder of Probusinessbank, a large Russian bank that was declared bankrupt after its license was revoked in 2014. Shortly after, Zheleznyak and other directors of the bank were declared responsible for the bank&amp;rsquo;s collapse due to mismanagement and embezzlement. Criminal cases were initiated in connection with the embezzlement allegations, but no judgment has been entered against Zheleznyak because he is not present in Russia. Zheleznyak left Russia in January 2016, when he moved to Israel, and now resides in the U.S.&lt;/p&gt;
&lt;p&gt;In August 2019, Probusinessbank&amp;rsquo;s application in Russia to declare Zheleznyak bankrupt was granted, and a Russian bankruptcy trustee was appointed. In March 2026, the Russian bankruptcy trustee filed a petition in the U.S. Bankruptcy Court for the District of Massachusetts seeking U.S. recognition of the ongoing Russian insolvency proceeding &amp;mdash; either as a &amp;ldquo;foreign main proceeding&amp;rdquo; or a &amp;ldquo;foreign nonmain proceeding&amp;rdquo; &amp;mdash; which would have allowed him to obtain an automatic stay and standing to secure broad discovery into Zheleznyak&amp;rsquo;s U.S. assets. Zheleznyak opposed the petition on the merits and also raised public policy objections, arguing that the Russian proceeding is politically motivated and corrupt.&lt;/p&gt;
&lt;p&gt;The court denied the petition in full. On the &amp;ldquo;foreign main proceeding&amp;rdquo; question, the court held that because Zheleznyak&amp;rsquo;s habitual residence is undisputedly in the U.S., his COMI is presumed to be here, and the Russian bankruptcy trustee failed to rebut that presumption &amp;mdash; Zheleznyak&amp;rsquo;s Russian citizenship, prior legal income in Russia (last earned in 2019), bar membership, and Russian property ownership were all found insufficient to shift his COMI to Russia. On the &amp;ldquo;foreign nonmain proceeding&amp;rdquo; question, the court held that Zheleznyak lacks an &amp;ldquo;establishment&amp;rdquo; in Russia because he has not conducted any nontransitory economic activity there since 2016. More specifically, the court held that merely owning property in a country that one has not visited in nearly a decade amounts to no more than passive asset maintenance. Because neither recognition standard was met, the court did not address Zheleznyak&amp;rsquo;s argument that the petition should be denied due to the Russian government&amp;rsquo;s political motivations or his other associated relief requests.&lt;/p&gt;
&lt;h3&gt;&lt;em&gt;In re Siu-Fung Ceramics Holdings Limited&lt;/em&gt;[[N:No. 24-33299, 2026 WL 382424 (Bankr. S.D. Tex. Feb. 10, 2026).]]&lt;/h3&gt;
&lt;p&gt;This decision is significant for two reasons. First, courts are split over whether a debtor must, as a precondition to availing itself of Chapter 15&amp;rsquo;s benefits, have property in the U.S. on the Chapter 15 petition date. This court held that a debtor must have U.S.-based assets on the petition date. Second, the court held that in certain circumstances, none of which were present here, non-speculative potential U.S. litigation claims may be sufficient to satisfy the requirement that the debtor have property in the U.S. on the Chapter 15 petition date.&lt;/p&gt;
&lt;p&gt;Liquidators sought recognition under Chapter 15 of two related Hong Kong foreign proceedings in the Bankruptcy Court for the Southern District of Texas: the liquidation of the Siu-Fung Group and the personal bankruptcy of its former owner, Siu-Fung Siegfried Lee. At the time the Chapter 15 petitions were filed, both Hong Kong proceedings had been pending for approximately 25 years, suffering through years of highly contentious litigation involving investigations into the Siu-Fung Group&amp;rsquo;s collapse and Mr. Lee&amp;rsquo;s contributions, and Mr. Lee had been living in the U.S. for approximately eight years. Indeed, the Hong Kong liquidators sought Chapter 15 recognition to achieve access to U.S. courts and employ U.S. law discovery mechanisms to gain insights into Mr. Lee, his assets, and his contributions to the Siu-Fung Group&amp;rsquo;s collapse.[[N:&lt;em&gt;In re Siu-Fung Ceramics Holdings Limited&lt;/em&gt;, Case No. 24-33299, ECF No. 151 (Foreign Representative&amp;rsquo;s Trial Brief in Support of Amended Verified Petition for Recognition of Foreign Proceedings) at 10 (Bankr. S.D. Tex. September 5, 2025).]]&lt;/p&gt;
&lt;p&gt;The court agreed that the Siu-Fung Group&amp;rsquo;s COMI was Hong Kong, but still declined to recognize its Hong Kong proceeding, either as main or non-main, because the liquidators did not adequately demonstrate that the Siu-Fung Group had assets in the U.S. on the Chapter 15 petition date. The liquidators argued that the Siu-Fung Group did have assets in the U.S. by virtue of the legal retainer paid to U.S. counsel and the potential for them to assert U.S. litigation claims. The court rejected both arguments, holding that postpetition funding of a retainer for counsel is insufficient and that, here, the potential U.S. litigation claims also were insufficient because even the liquidators acknowledged them as speculative and tied to assets located outside the U.S. The court, however, did leave open the possibility that, under different circumstances, potential U.S. litigation claims could result in a finding that the debtor has assets in the U.S.&lt;/p&gt;
&lt;p&gt;The court also denied recognition of Mr. Lee&amp;rsquo;s personal insolvency proceeding, this time based on the liquidators&amp;rsquo; failure to establish that his COMI is in Hong Kong or that he has an establishment there. Because Mr. Lee left Hong Kong in 2016 and had been a continuous resident in the U.S. since 2017, and because nothing in the record suggested that he planned to return to Hong Kong or that he maintained any ongoing business presence there, the court held that his personal insolvency proceeding qualified neither as a foreign main proceeding nor a foreign non-main proceeding.&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{CF8637F0-1555-4B17-A498-EE9AF080BF52}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/forbes-names-2026-americas-top-women-lawyers-list</link><title>Forbes Names Five Arnold &amp; Porter Partners to 2026 America’s Top Women Lawyers List</title><description>&lt;p&gt;Five Arnold &amp;amp; Porter partners were recently named to Forbes&amp;rsquo; inaugural 2026 America&amp;rsquo;s Top Women Lawyers list, which recognizes 200 of the nation&amp;rsquo;s most accomplished women attorneys across a broad range of practice areas whose leadership, influence, and achievements are shaping the future of the legal profession.&lt;/p&gt;</description><pubDate>Mon, 08 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Five Arnold &amp;amp; Porter partners were recently named to &lt;em&gt;Forbes&amp;rsquo;&lt;/em&gt; inaugural 2026 America&amp;rsquo;s Top Women Lawyers list, which recognizes 200 of the nation&amp;rsquo;s most accomplished women attorneys across a broad range of practice areas whose leadership, influence, and achievements are shaping the future of the legal profession.&lt;/p&gt;
&lt;p&gt;The following partners were recognized in their respective practice areas:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Sheila S. Boston&lt;/strong&gt; &amp;mdash; Litigation&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Deborah Curtis &lt;/strong&gt;&amp;mdash; White Collar Defense&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Debbie Feinstein&lt;/strong&gt; &amp;mdash; Antitrust Law&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Ellen Kaye Fleishhacker&lt;/strong&gt; &amp;mdash; Investment Funds &amp;amp; Asset Management&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Jami Vibbert &lt;/strong&gt;&amp;mdash; Privacy, Cybersecurity &amp;amp; Data Protection&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Honorees were selected through a rigorous, multi-step evaluation process that reviewed thousands of nominees and assessed multiple factors, including notable litigation and transactional work, leadership, client impact, firm and community engagement, and recognition within the broader legal industry.&lt;/p&gt;
&lt;p&gt;According to &lt;em&gt;Forbes&lt;/em&gt;, the lawyers recognized are among the profession&amp;rsquo;s most influential practitioners, guiding high-stakes matters, navigating complex legal challenges, and helping define the legal and business landscape.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{EB7B6436-E744-4AD9-AA2C-3C914337062F}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/dave-thomas-foundations-2026-100-best-adoption-friendly-workplaces-list</link><title>Arnold &amp; Porter Named to Dave Thomas Foundation’s 2026 ‘100 Best Adoption-Friendly Workplaces’ List</title><description>Arnold &amp;amp; Porter was named to the Dave Thomas Foundation for Adoption's &amp;ldquo;100 Best Adoption-Friendly Workplaces&amp;rdquo; list. The firm has been recognized by the Dave Thomas Foundation for its adoption benefits every year since 2015. The list celebrates organizations that offer the most robust leave and adoption benefits in the United States.</description><pubDate>Mon, 08 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter was named to the Dave Thomas Foundation for Adoption's &amp;ldquo;100 Best Adoption-Friendly Workplaces&amp;rdquo; list. The firm has been recognized by the Dave Thomas Foundation for its adoption benefits every year since 2015. The list celebrates organizations that offer the most robust leave and adoption benefits in the United States.&lt;/p&gt;
&lt;p&gt;The firm was once again recognized in the &amp;ldquo;Top 100&amp;rdquo; and &amp;ldquo;Consulting, Accounting, Legal, and Business Services&amp;rdquo; categories. The firm was also included in the &amp;ldquo;Best by Industry&amp;rdquo; list, which highlights organizations that &amp;ldquo;offer the best overall adoption benefits&amp;rdquo; by industry, and in the &amp;ldquo;Best by Size&amp;rdquo; list, alongside several other categories.&lt;/p&gt;
&lt;p&gt;The Dave Thomas Foundation surveys companies across the U.S. and scores participants based on three criteria: financial reimbursement, paid leave, and the percentage of employees eligible for those benefits. The Foundation also ranks employers by size, industry, paid leave, foster care benefits, and impact.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{0F5DD95F-8D4E-4365-A996-1F6D06FC6C1E}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/capital-snapshot-june-2026</link><a10:author><a10:name>Eugenia E. Pierson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pierson-eugenia-e</a10:uri><a10:email>Eugenia.Pierson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Allison Jarus</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jarus-allison</a10:uri><a10:email>allison.jarus@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter E. Duyshart</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/duyshart-peter</a10:uri><a10:email>peter.duyshart@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Crawford</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/crawford-emily</a10:uri><a10:email>emily.crawford@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Mahaffy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mahaffy-emily</a10:uri><a10:email>emily.mahaffy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dylan L. Kelemen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kelemen-dylan-l</a10:uri><a10:email>dylan.kelemen@arnoldporter.com</a10:email></a10:author><title>Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions</title><description>Our Legislative &amp;amp; Public Policy team is pleased to provide the June 2026 edition of &lt;em&gt;Capital Snapshot&lt;/em&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions.&amp;nbsp;</description><pubDate>Mon, 08 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;Our Legislative &amp;amp; Public Policy team is pleased to provide the June 2026 edition of &lt;em&gt;Capital Snapshot&lt;/em&gt;, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the &lt;em&gt;Capital Snapshot &lt;/em&gt;contains a review of the landscape of the 119&lt;sup&gt;th&lt;/sup&gt; Congress, including upcoming congressional schedules and key dates, and recently announced retirements, resignations, vacancies, and special elections. We also share updates pertaining to the Republican reconciliation bill to fund ICE and CBP, and the FY27 federal funding and appropriations processes. Our team also provides comprehensive updates on the latest on trade and tariffs. Furthermore, we share some salient legislative and policy updates across a variety of additional key policy areas, including: (1) defense; (2) tax; (3) financial services; (4) artificial intelligence; (5) technology; (6) data privacy; (7) health care; (8) education; and (9) energy and environment. Additionally, we provide an overview and outlook of the upcoming 2026 midterm elections in November, as well as an update to our detailed rundown of various mid-decade redistricting efforts across the country ahead of the midterms. Our team also takes a look at current public opinion polling on President Trump&amp;rsquo;s job performance and policy priorities, and assesses economic factors and conditions that could impact the future political landscape in an election year.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D297C0DE-33C8-471C-AEE3-FFDDEA3B62A9}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/new-applicability-dates-of-proposed-section-892-regulations</link><a10:author><a10:name>David A. Sausen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sausen-david-a</a10:uri><a10:email>david.sausen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sean Kavanaugh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kavanaugh-sean</a10:uri><a10:email>sean.kavanaugh@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>MJ Wang</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wang-mj</a10:uri><a10:email>mj.wang@arnoldporter.com</a10:email></a10:author><title>New Applicability Dates of Proposed Section 892 Regulations</title><description>The U.S. Department of the Treasury (Treasury) and Internal Revenue Service (IRS) have issued proposed regulations providing transition relief for foreign governments and sovereign wealth funds affected by the forthcoming Section 892 rules on debt acquisitions and effective control. The guidance would delay application of key provisions in the &lt;span&gt;regulations published in &lt;/span&gt;2025 and preserve existing treatment for certain preexisting and transitional investments, while Treasury and the IRS continue evaluating comments on the broader Section 892 framework.</description><pubDate>Mon, 08 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On June 1, 2026, the U.S. Department of the Treasury (the Treasury) and the Internal Revenue Service (the IRS) published &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/06/01/2026-10841/income-of-foreign-governments-and-of-international-organizations" target="_blank"&gt;proposed regulations&lt;/a&gt; (the 2026 Proposed Regulations) addressing the applicability dates of proposed regulations published last year (the 2025 Proposed Regulations) regarding the Section 892 tax exemption for foreign governments.[[N:&lt;span&gt;All references to a &amp;ldquo;Section&amp;rdquo; refer to a section of the U.S. Internal Revenue Code of 1986, as amended.]]&lt;/span&gt;&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;By way of background and in general, the Section 892 tax exemption for foreign governments does not apply to certain income, including income derived from the conduct of commercial activities and income received from a controlled commercial entity, which includes an entity engaged in commercial activities over which a foreign government has effective control.&lt;/p&gt;
&lt;p&gt;The 2025 Proposed Regulations provide rules for determining whether an acquisition of debt constitutes commercial activity and whether a foreign government has effective control over an entity. For a detailed discussion of the 2025 Proposed Regulations, please see our &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/02/2025-regulations-regarding-the-section-892-tax-exemption" target="_self"&gt;February 2026 Advisory&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;In response to comments regarding the applicability dates of the 2025 Proposed Regulations, the 2026 Proposed Regulations provide rules to ensure that certain existing investments, as well as investments acquired during a transition period, would not be subject to the new debt acquisition and effective control rules in the finalized 2025 Proposed Regulations.&lt;/p&gt;
&lt;h2&gt;Debt Acquisition Rules&lt;/h2&gt;
&lt;p&gt;The 2026 Proposed Regulations provide foreign governments with a transition period, before the new debt acquisition rules in the finalized 2025 Proposed Regulations apply, of at least 90 days after the date the 2025 Proposed Regulations are finalized, or until the start of the acquirer&amp;rsquo;s first taxable year after that date.&lt;/p&gt;
&lt;p&gt;Specifically, if debt is acquired before the end of the transition period or is acquired pursuant to a binding commitment entered into before the end of that period, the existing rules applicable before the 2025 Proposed Regulations are finalized would continue to apply to determine whether that acquisition is commercial activity.&lt;/p&gt;
&lt;p&gt;The Preamble to the 2026 Proposed Regulations provides that, because it is the acquisition of debt, and not the mere holding of debt, that is potentially treated as commercial activity, a debt acquirer is not engaged in commercial activity in taxable years following the taxable year of the acquisition of the debt solely by reason of holding the debt in subsequent taxable years. The Preamble further provides that debt acquired in a previous year and held in the current year does not cause other debt acquisitions in the current year to be treated as commercial activity.&lt;/p&gt;
&lt;h2&gt;Effective Control Rules&lt;/h2&gt;
&lt;p&gt;The 2026 Proposed Regulations would similarly provide foreign governments with a transition period, before the new effective control rules in the finalized 2025 Proposed Regulations apply, of at least 90 days after the date the 2025 Proposed Regulations are finalized, or until the start of the foreign government&amp;rsquo;s first taxable year after that date.&lt;/p&gt;
&lt;p&gt;Furthermore, the effective control rules in the finalized 2025 Proposed Regulations would not apply to a foreign government&amp;rsquo;s existing interests in an entity unless, after the transition period, and excluding acquisitions pursuant to a binding commitment entered into before the end of that period, the foreign government acquires additional interests in the entity that, by themselves, would provide the foreign government with effective control under the finalized 2025 Proposed Regulations. Unless and until this occurs, whether that entity is a controlled commercial entity would be determined under the existing rules applicable before the 2025 Proposed Regulations are finalized.&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The 2026 Proposed Regulations address only the applicability dates of the 2025 Proposed Regulations. The Preamble to the 2026 Proposed Regulations provides that the Treasury and the IRS recognize the importance of the other comments they received regarding the substantive aspects of the 2025 Proposed Regulations, and are evaluating how to reflect those comments in future guidance, taking into account established market practices and the general policy to support current and future sovereign wealth fund investment in the United States.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{15B04A08-0AA1-4CC0-A565-3DCD6BDDBE9C}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/arnold-and-porter-awarded-deal-of-the-year</link><title>Arnold &amp; Porter awarded Deal of the Year (2025) for work on establishing the U.S.–Ukraine Reconstruction Investment Fund </title><description>Arnold &amp;amp; Porter is pleased to announce that our work on the transaction establishing the United States&amp;ndash;Ukraine Reconstruction Investment Fund has been awarded Deal of the Year (CEE).&amp;nbsp;</description><pubDate>Thu, 04 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter is pleased to announce that our work on the transaction establishing the United States&amp;ndash;Ukraine Reconstruction Investment Fund has been awarded Deal of the Year (CEE). The matter, led by partners Gregory Harrington (Washington, DC) and Chris Willott (New York), with significant assistance from Colleen Couture (Washington, DC) and Valentina Garzon (Washington, DC), involved negotiations between the U.S. and Ukrainian governments relating to the development and investment framework for Ukraine&amp;rsquo;s critical minerals and reconstruction sectors.&lt;/p&gt;
&lt;p&gt;Presented annually by CEE Legal Matters, the award recognized the most significant landmark deals across Central and Eastern Europe.&lt;/p&gt;
&lt;p&gt;Award winners were announced at a Gala Dinner on May 27, 2026, in Bucharest.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{5EC1DC2B-9374-4ECF-A5B4-288B14D528C4}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/arnold-and-porter-advises-on-launch-of-life-sciences-investment-firm-banyan-bio</link><title>Arnold &amp; Porter Advises on Launch of Life Sciences Investment Firm Banyan Bio</title><description>Arnold &amp;amp; Porter recently advised Banyan BioInnovations (&amp;ldquo;Banyan Bio&amp;rdquo;) in its launch as an investment firm. At the time of its launch, announced on May 5, 2026, Banyan Bio had secured more than $100 million in initial commitments from life sciences investors, including ICON plc, a clinical research organization.</description><pubDate>Thu, 04 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised Banyan BioInnovations (&amp;ldquo;Banyan Bio&amp;rdquo;) in its launch as an investment firm. At the time of its launch, announced on May 5, 2026, Banyan Bio had secured more than $100 million in initial commitments from life sciences investors, including ICON plc, a clinical research organization.&lt;/p&gt;
&lt;p&gt;The new firm, staffed by more than 50 drug developers and dealmakers and powered by life sciences investment bank Locust Walk Capital, LLC, will identify clinical-stage drug assets, form NewCos around them, and provide development support. For its assets, Banyan Bio will lead due diligence, planning, and strategy, and will offer operations, regulatory, and CMC advice.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by partner Todd Boudreau and included partners Simon Firth and Alyssa Hogan, associate Peter Klopfenstein, senior attorney Greg Caramenico, and attorney and advisor Brandon Alexander. Partner David Sausen and counsel Gus Weinkam advised on tax matters.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{79335310-CC76-4837-93B7-1EE0A133B16E}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/chambers-usa-2026</link><title>Chambers USA 2026 Ranks 142 Arnold &amp; Porter Lawyers, 75 Practices</title><description>The 2026 edition of &lt;em&gt;Chambers USA&lt;/em&gt; named Arnold &amp;amp; Porter a &amp;ldquo;Leading Firm&amp;rdquo; in 75 practice areas across the nation and recognized 142 lawyers as &amp;ldquo;Leading Individuals.&amp;rdquo;&lt;br /&gt;
&lt;br /&gt;
&lt;em&gt;Chambers&lt;/em&gt; noted Arnold &amp;amp; Porter&amp;rsquo;s experience representing &amp;ldquo;clients on large, high-stakes and complex deals, litigation and investigatory matters,&amp;rdquo; and highlighted the firm&amp;rsquo;s &amp;ldquo;considerable depth and breadth of experience across the board.&amp;rdquo;</description><pubDate>Thu, 04 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 2026 edition of &lt;em&gt;Chambers USA&lt;/em&gt; named Arnold &amp;amp; Porter a &amp;ldquo;Leading Firm&amp;rdquo; in 75 practice areas across the nation and recognized 142 lawyers as &amp;ldquo;Leading Individuals.&amp;rdquo;&lt;br /&gt;
&lt;br /&gt;
&lt;em&gt;Chambers&lt;/em&gt; noted Arnold &amp;amp; Porter&amp;rsquo;s experience representing &amp;ldquo;clients on large, high-stakes and complex deals, litigation and investigatory matters,&amp;rdquo; and highlighted the firm&amp;rsquo;s &amp;ldquo;considerable depth and breadth of experience across the board.&amp;rdquo;&lt;br /&gt;
&lt;br /&gt;
Clients who spoke to&lt;em&gt; Chambers&lt;/em&gt; called Arnold &amp;amp; Porter a &amp;ldquo;go-to firm&amp;rdquo; and the &amp;ldquo;best of the best&amp;rdquo; at the &amp;ldquo;top of the market.&amp;rdquo; They also reported the firm&amp;rsquo;s &amp;ldquo;regulatory knowledge and experience are unmatched,&amp;rdquo; that Arnold &amp;amp; Porter provided &amp;ldquo;exemplary, client-centered advocacy,&amp;rdquo; and that the firm &amp;ldquo;consistently demonstrated deep-subject matter expertise, paired with a highly tactical and practical approach.&amp;rdquo;&lt;br /&gt;
&lt;br /&gt;
Clients also spoke highly of Arnold &amp;amp; Porter attorneys, noting that &amp;ldquo;the lawyers are practical, very responsive and know all of the players,&amp;rdquo; &amp;ldquo;incredibly smart and strategic,&amp;rdquo; and work as &amp;ldquo;a very effective team that is able to cut through complex processes and situations.&amp;rdquo;&lt;br /&gt;
&lt;br /&gt;
Overall, &lt;em&gt;Chambers USA &lt;/em&gt;recognized 28 practice areas and 61 lawyer rankings in Bands 1 and 2.&lt;br /&gt;
&lt;br /&gt;
The following is a list of the 75 practices ranked nationally and across nine regions:&lt;br /&gt;
&lt;br /&gt;
&lt;em&gt;*Denotes Band 1 ranking&lt;/em&gt;&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;Nationwide&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Accountant and Auditor Liability&lt;/li&gt;
    &lt;li&gt;Advertising: Litigation&lt;/li&gt;
    &lt;li&gt;Advertising: Transactional &amp;amp; Regulatory&lt;/li&gt;
    &lt;li&gt;Antitrust*&lt;/li&gt;
    &lt;li&gt;Antitrust: Cartel&lt;/li&gt;
    &lt;li&gt;Appellate Law&lt;/li&gt;
    &lt;li&gt;Artificial Intelligence&lt;/li&gt;
    &lt;li&gt;Bankruptcy/Restructuring: Highly Regarded*&lt;/li&gt;
    &lt;li&gt;Capital Markets: Securitization: ABS&lt;/li&gt;
    &lt;li&gt;Climate Change&lt;/li&gt;
    &lt;li&gt;Corporate Crime &amp;amp; Investigations: The Elite&lt;/li&gt;
    &lt;li&gt;Corporate/M&amp;amp;A: Highly Regarded&lt;/li&gt;
    &lt;li&gt;Environment&lt;/li&gt;
    &lt;li&gt;False Claims Act*&lt;/li&gt;
    &lt;li&gt;Financial Services Regulation: Banking (Compliance)&lt;/li&gt;
    &lt;li&gt;Financial Services Regulation: Banking (Enforcement &amp;amp; Investigations)&lt;/li&gt;
    &lt;li&gt;Food &amp;amp; Beverages: Regulatory &amp;amp; Litigation&lt;/li&gt;
    &lt;li&gt;Government Contracts: The Elite*&lt;/li&gt;
    &lt;li&gt;Government Relations: Federal&lt;/li&gt;
    &lt;li&gt;Healthcare: Highly Regarded*&lt;/li&gt;
    &lt;li&gt;Intellectual Property&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patent Trial and Appeal Boar&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademark &amp;amp; Copyright&lt;/li&gt;
    &lt;li&gt;International Arbitration: The Elite&lt;/li&gt;
    &lt;li&gt;International Trade: Export Controls &amp;amp; Economic Sanctions: The Elite&lt;/li&gt;
    &lt;li&gt;International Trade: Trade Remedies &amp;amp; Trade Policy&lt;/li&gt;
    &lt;li&gt;Leisure &amp;amp; Hospitality&lt;/li&gt;
    &lt;li&gt;Life Sciences&lt;/li&gt;
    &lt;li&gt;Life Sciences: Regulatory/Compliance*&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial: The Elite&lt;/li&gt;
    &lt;li&gt;Privacy &amp;amp; Data Security: Highly Regarded*&lt;/li&gt;
    &lt;li&gt;Product Liability &amp;amp; Mass Torts: The Elite*&lt;/li&gt;
    &lt;li&gt;Product Liability: Regulatory*&lt;/li&gt;
    &lt;li&gt;Retail&lt;/li&gt;
    &lt;li&gt;Sports Law&lt;/li&gt;
    &lt;li&gt;Transportation: Aviation: Litigation&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;California&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Environment&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patent Litigation&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets&lt;/li&gt;
    &lt;li&gt;Life Sciences: IP/Patent Litigation&lt;/li&gt;
    &lt;li&gt;Litigation: Appellate&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial: Highly Regarded*&lt;/li&gt;
    &lt;li&gt;Technology&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;California: San Francisco, Silicon Valley &amp;amp; Surrounds&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Corporate/M&amp;amp;A: Highly Regarded*&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Colorado&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Litigation: General Commercial&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;District of Columbia&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Antitrust*&lt;/li&gt;
    &lt;li&gt;Bankruptcy/Restructuring*&lt;/li&gt;
    &lt;li&gt;Corporate/M&amp;amp;A &amp;amp; Private Equity&lt;/li&gt;
    &lt;li&gt;Environment*&lt;/li&gt;
    &lt;li&gt;Healthcare&lt;/li&gt;
    &lt;li&gt;Healthcare: Pharmaceutical/Medical Products Regulatory*&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Litigation&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patent Prosecution&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial: The Elite&lt;/li&gt;
    &lt;li&gt;Litigation: White-Collar Crime &amp;amp; Government Investigations&lt;/li&gt;
    &lt;li&gt;Real Estate*&lt;/li&gt;
    &lt;li&gt;Tax&lt;/li&gt;
    &lt;li&gt;Telecom, Broadcast &amp;amp; Satellite&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Illinois&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Bankruptcy/Restructuring&lt;/li&gt;
    &lt;li&gt;Environment&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;New Jersey&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Litigation: White-Collar Crime &amp;amp; Government Investigations&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;New York&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Antitrust&lt;/li&gt;
    &lt;li&gt;Corporate/M&amp;amp;A: Highly Regarded&lt;/li&gt;
    &lt;li&gt;Environment&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Patent&lt;/li&gt;
    &lt;li&gt;Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial: Highly Regarded*&lt;/li&gt;
    &lt;li&gt;Litigation: White-Collar Crime &amp;amp; Government Investigations: The Elite&lt;/li&gt;
    &lt;li&gt;Real Estate: Mainly Corporate &amp;amp; Finance&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Texas: Houston &amp;amp; Surrounds&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Litigation: General Commercial&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Washington&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;&lt;/strong&gt;Labor &amp;amp; Employment&lt;/li&gt;
    &lt;li&gt;Litigation: General Commercial&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Arnold &amp;amp; Porter&amp;rsquo;s ranked lawyers in Chambers USA 2026 include:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Anand Agneshwar: Product Liability &amp;amp; Mass Torts &amp;ndash; Nationwide*; Product Liability: Pharmaceutical &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Richard M. Alexander: Financial Services Regulation: Banking (Enforcement &amp;amp; Investigations) &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Rosemary Alito: Labor &amp;amp; Employment &amp;ndash; New Jersey*&lt;/li&gt;
    &lt;li&gt;Christopher Anderson: Healthcare &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;R. Reeves Anderson: Litigation: Appellate &amp;ndash; Colorado*; Litigation: General Commercial &amp;ndash; Colorado&lt;/li&gt;
    &lt;li&gt;Marcus A. Asner: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Robert C. Azarow: Financial Services Regulation: Financial Institutions M&amp;amp;A &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;John P. Barker: International Trade: Export Controls &amp;amp; Economic Sanctions &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Annette E. Becker: Corporate/M&amp;amp;A &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;C. Fredrick Beckner III: Telecom, Broadcast &amp;amp; Satellite &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Michael B. Bernstein: Antitrust &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Marisa N. Bocci: Real Estate &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;Jon M. Boswell: Real Estate &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Arthur E. Brown: Product Liability &amp;amp; Mass Torts &amp;ndash; Nationwide; Product Liability: Pharmaceutical &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Veronica E. Callahan: Accountant and Auditor Liability &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Gina M. Cavalier: Healthcare &amp;ndash; California&lt;/li&gt;
    &lt;li&gt;Maria Chedid: International Arbitration: Counsel &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Eun Young Choi: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;James W. Cooper: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Lee M. Cortes, Jr.: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New Jersey&lt;/li&gt;
    &lt;li&gt;Rachel F. Cotton: Government Relations: Congressional Investigations &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Lawrence E. Culleen: Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Deborah A. Curtis: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; District of Columbia; National Security &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Michael D. Daneker: Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Kara L. Daniels: Government Contracts &amp;ndash; Nationwide*; Government Contracts: Bid Protests &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Mahnu V. Davar: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia; Life Sciences: Regulatory/Compliance &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Paolo Di Rosa: International Arbitration: Counsel &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;John P. Elwood: Appellate Law &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Rosa J. Evergreen: Bankruptcy/Restructuring &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Zachary Fayne: Environment &amp;ndash; California&lt;/li&gt;
    &lt;li&gt;Debbie Feinstein: Antitrust &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;John M. Fietkiewicz: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New Jersey&lt;/li&gt;
    &lt;li&gt;Mark Filipini: Labor &amp;amp; Employment &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;Deborah Fishman: Intellectual Property: Patent Litigation &amp;ndash; California; Life Sciences: IP/Patent Litigation &amp;ndash; California&lt;/li&gt;
    &lt;li&gt;Paul J. Fishman: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New Jersey*&lt;/li&gt;
    &lt;li&gt;Lynn Fischer Fox: International Trade: Trade Remedies &amp;amp; Trade Policy &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;David F. Freeman, Jr.: Financial Services Regulation: Banking (Compliance) &amp;ndash; Nationwide; Financial Services Regulation: Broker Dealer (Compliance) &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;S. Michael Gentine: Product Liability: Regulatory &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Andre Geverola: Antitrust &amp;ndash; Illinois; Antitrust: Cartel &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Michelle F. Gillice: Product Liability: Regulatory &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Jonathan Gleklen: Antitrust &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Stephen Gliatta: Real Estate: Finance &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Michael D. Goodwin: Real Estate &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;John Gould: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Sarah Grey: Climate Change &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Joel M. Gross: Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Sarah Gryll: Bankruptcy/Restructuring &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;John F. Hagan, Jr.: Litigation: General Commercial &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Louis J. Hait: Real Estate: Finance &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Stacey Halliday: Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Jeffrey L. Handwerker: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia*; Life Sciences: Regulatory/Compliance &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Dori Hanswirth: Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets &amp;ndash; New York; Media &amp;amp; Entertainment: First Amendment Litigation &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Michael J. Harris: Intellectual Property &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Amber A. Hay: Financial Services Regulation: Banking (Compliance) &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Valarie Hays: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Suneeta Hazra: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; Colorado*&lt;/li&gt;
    &lt;li&gt;Rhys W. Hefta: Real Estate &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;James D. Herschlein: Litigation: General Commercial &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Kristin M. Hicks: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;M&amp;eacute;lida Hodgson: International Arbitration: Arbitrators &amp;ndash; Nationwide; International Arbitration: Counsel &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;William Hoffman: Product Liability &amp;amp; Mass Torts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Craig A. Holman: Government Contracts &amp;ndash; Nationwide*; Government Contracts: Bid Protests &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Joseph G. Howe: REITS: Tax*&lt;/li&gt;
    &lt;li&gt;Kristen E. Ittig: Government Contracts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Maureen R. Jeffreys: Telecom, Broadcast &amp;amp; Satellite &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Giselle J. Joffre: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; Massachusetts&lt;/li&gt;
    &lt;li&gt;James P. Joseph: Tax &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Jeffrey H. Kapner: Real Estate: Finance &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Allon Kedem: Appellate Law &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Matt S. Kirsch: Real Estate &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Daniel A. Kracov: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia*; Life Sciences: Regulatory/Compliance &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Michael Kim Krouse: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Kevin J. Lavin: Corporate/M&amp;amp;A &amp;amp; Private Equity &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Ronald D. Lee: Privacy &amp;amp; Data Security: Cybersecurity &amp;ndash; Nationwide; Privacy &amp;amp; Data Security: Privacy &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;C. Scott Lent: Antitrust &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Ronald R. Levine, II: Corporate/M&amp;amp;A &amp;ndash; Colorado*&lt;/li&gt;
    &lt;li&gt;Paul C. Llewellyn: Intellectual Property: Trademark &amp;amp; Copyright &amp;ndash; Nationwide; Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Tirzah S. Lollar: False Claims Act &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Patrick M. Madden: Labor &amp;amp; Employment &amp;ndash; Washington*&lt;/li&gt;
    &lt;li&gt;Thomas A. Magnani: Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets: Transactional &amp;ndash; California*; Technology &amp;ndash; California&lt;/li&gt;
    &lt;li&gt;Craig D. Margolis: False Claims Act &amp;ndash; Nationwide*; Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;David R. Marsh: Intellectual Property: Patent Prosecution &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Jonathan S. Martel: Climate Change &amp;ndash; Nationwide; Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Michael McGill: Government Contracts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Michael D. Messersmith: Bankruptcy/Restructuring &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Saul P. Morgenstern: Antitrust &amp;ndash; New York*&lt;/li&gt;
    &lt;li&gt;John N. Nassikas: Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Brandon W. Neuschafer: Environment: Mainly Transactional &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Todd L. Nunn: Labor &amp;amp; Employment &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;Tyler D. Nurnberg: Bankruptcy/Restructuring &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Colin M. O'Brien: Litigation: General Commercial &amp;ndash; Colorado&lt;/li&gt;
    &lt;li&gt;Daphne O'Connor: Product Liability: Tobacco &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Christopher M. Odell: Litigation: General Commercial &amp;ndash; Texas: Houston and Surrounds; Transportation: Aviation: Litigation &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Kathryn E. Olson: Leisure &amp;amp; Hospitality &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Kevin O'Neill: Government Relations: Federal &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Daniel S. Pariser: Product Liability &amp;amp; Mass Torts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;J. David Park: International Trade: Trade Remedies &amp;amp; Trade Policy &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Jin-Suk Park: Intellectual Property: Litigation &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Jennifer Perkins: Real Estate &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Nancy L. Perkins: Privacy &amp;amp; Data Security: Privacy &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Christopher P. Peterson: Capital Markets: Debt &amp;amp; Equity: Eastern United States &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Sonia Kuester Pfaffenroth: Antitrust &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Stephanie Wright Pickett: Labor &amp;amp; Employment &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;Raqiyyah Pippins: Advertising: NAD Proceedings &amp;ndash; Nationwide; Advertising: Transactional &amp;amp; Regulatory &amp;ndash; Nationwide; Food &amp;amp; Beverages: Regulatory &amp;amp; Litigation &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Kathleen Reilly: Accountant and Auditor Liability &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Christopher J. Renk: Intellectual Property: Trademark, Copyright &amp;amp; Trade Secrets &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Amy B. Rifkind: Real Estate &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Sandra E. Rizzo: Energy: Electricity (Regulatory &amp;amp; Litigation) &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Michael A. Rogoff: False Claims Act &amp;ndash; Nationwide; Litigation: White-Collar Crime &amp;amp; Government Investigations &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Carmela T. Romeo: Litigation: General Commercial &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Evan M. Rothstein: Intellectual Property &amp;ndash; Colorado&lt;/li&gt;
    &lt;li&gt;Eric A. Rubel: Product Liability: Regulatory &amp;ndash; Nationwide*&lt;/li&gt;
    &lt;li&gt;Gary R. Schall: Startups &amp;amp; Emerging Companies &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Scott B. Schreiber: Insurance: Insurer &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Christian D. H. Schultz: Litigation: Securities &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Kenneth L. Schwartz: Real Estate &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Sean M. SeLegue: Litigation: Appellate &amp;ndash; California*&lt;/li&gt;
    &lt;li&gt;Ali R. Sharifahmadian: Intellectual Property: Patent Trial and Appeal Board &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Christian D. Sheehan: False Claims Act &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Ethan G. Shenkman: Climate Change &amp;ndash; Nationwide; Environment &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Amanda J. Sherwood: Government Contracts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Laura Shores: Antitrust: Litigation Specialists &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Allison W. Shuren: Healthcare &amp;ndash; District of Columbia*&lt;/li&gt;
    &lt;li&gt;Kelsie Sicinski: Product Liability: Regulatory &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Howard Sklamberg: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Carey W. Smith: Real Estate &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Stephanna F. Szotkowski: Litigation: Securities &amp;ndash; Illinois&lt;/li&gt;
    &lt;li&gt;Matthew Tabas: Antitrust &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Sonia Tabriz: Government Contracts &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Jeffrey D. Talbert: Environment &amp;ndash; New Jersey*; Environment &amp;ndash; New York&lt;/li&gt;
    &lt;li&gt;Eva Temkin: Healthcare: Pharmaceutical/Medical Products Regulatory &amp;ndash; District of Columbia; Life Sciences: Regulatory/Compliance &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Kevin M. Toomey: Financial Services Regulation: Banking (Enforcement &amp;amp; Investigations) &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Katherine Ginzburg Treistman: Litigation: General Commercial &amp;ndash; Texas: Houston and Surrounds&lt;/li&gt;
    &lt;li&gt;Andrew Varner: Corporate/M&amp;amp;A &amp;amp; Private Equity &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Jami Vibbert: Privacy &amp;amp; Data Security: Healthcare &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Pallavi Mehta Wahi: Litigation: General Commercial &amp;ndash; Washington&lt;/li&gt;
    &lt;li&gt;Jessica L. Wang: Product Liability: Regulatory &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;David J. Weiner: Litigation: General Commercial &amp;ndash; District of Columbia; Transportation: Aviation: Litigation &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Bridget M. Weiss: Tax &amp;ndash; District of Columbia&lt;/li&gt;
    &lt;li&gt;Matthew M. Wolf: Intellectual Property &amp;ndash; Nationwide; Intellectual Property: Litigation &amp;ndash; District of Columbia*; Life Sciences: IP/Patent Litigation &amp;ndash; Nationwide&lt;/li&gt;
    &lt;li&gt;Betty Yan: Corporate/M&amp;amp;A &amp;ndash; New Jersey&lt;/li&gt;
    &lt;li&gt;Pamela J. Yates: Product Liability &amp;amp; Mass Torts &amp;ndash; Nationwide&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{585F59DE-1B5D-4A87-B234-C319451CF1F2}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/personal-care-products-council-2026-legal-and-regulatory-conference</link><author>raqiyyah.pippins@arnoldporter.com</author><title>Personal Care Products Council 2026 Legal and Regulatory Conference</title><description>The conference brings together attorneys, scientists, and regulatory affairs professionals to address the current challenges facing the personal care industry, with sessions covering the latest legal and regulatory developments.</description><pubDate>Wed, 03 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter is proud to sponsor the &lt;a rel="noopener noreferrer" href="https://www.personalcarecouncil.org/event/2026-legal-and-regulatory-conference/" target="_blank"&gt;Personal Care Products Council 2026 Legal and Regulatory Conference&lt;/a&gt;, taking place June 3&amp;ndash;5, 2026 at The Drake Hotel. The conference brings together attorneys, scientists, and regulatory affairs professionals to address the current challenges facing the personal care industry, with sessions covering the latest legal and regulatory developments, including a dedicated half-day on Extended Producer Responsibility (EPR) laws and emerging sustainability compliance requirements.&lt;/p&gt;
&lt;p&gt;Partner Raqiyyah Pippins will also be presenting at the conference, speaking on "Keeping Pace with Modern Marketing: Practical Claim Substantiation in the Age of AI and Influencers" on June 3, 2026. Today's consumer marketing moves at speed, especially when AI-driven features, and influencer partnerships are involved. This session breaks down what claim substantiation should look like in practice, how to align performance and "health-adjacent" messaging with available evidence, and where common pitfalls arise when third-party content or digital UX claims get ahead of claim support. Attendees will leave with pragmatic tips for reducing risk while preserving compelling brand storytelling.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A43D11EB-F2E0-40AD-B249-F0B637513337}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/san-francisco-business-times-recognizes-tom-magnani-as-an-outstanding-voice-in-the-bay-area</link><title>San Francisco Business Times Recognizes Tom Magnani as an Outstanding Voice in the Bay Area</title><description>Tom Magnani, head of Arnold &amp;amp; Porter&amp;rsquo;s Technology Transactions practice and co-chair of the firm&amp;rsquo;s Technology &amp;amp; Media industry group and Artificial Intelligence (AI) group, has been named one of the &lt;em&gt;San Francisco Business Times&lt;/em&gt;&amp;rsquo; 2026 Outstanding Voices.&amp;nbsp;</description><pubDate>Wed, 03 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Tom Magnani, head of Arnold &amp;amp; Porter&amp;rsquo;s Technology Transactions practice and co-chair of the firm&amp;rsquo;s Technology &amp;amp; Media industry group and Artificial Intelligence (AI) group, has been named one of the &lt;em&gt;San Francisco Business Times&lt;/em&gt;&amp;rsquo; 2026 Outstanding Voices. The recognition is part of the publication&amp;rsquo;s annual Business of Pride program, which honors LGBTQ+ leaders who have made significant contributions to the Bay Area business community.&lt;/p&gt;
&lt;p&gt;Tom is among a select group of honorees recognized for their leadership and impact within the LGBTQ+ community and the broader business landscape. He was honored at the publication&amp;rsquo;s Business of Pride Celebration and Awards Ceremony on June 2 in San Francisco and will be featured in an upcoming special edition of the &lt;em&gt;San Francisco Business Times&lt;/em&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{78DD6346-B9E1-41EC-94D8-290A84D230EC}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/the-iccs-2026-arbitration-rules-an-early-preview-of-the-changes-part-2</link><a10:author><a10:name>Maria Chedid</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chedid-maria</a10:uri><a10:email>maria.chedid@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter L. Schmidt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmidt-peter</a10:uri><a10:email>peter.schmidt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brooke F. D'Amore Bradley</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/damore-bradley-brooke</a10:uri><a10:email>brooke.damorebradley@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Lindsey II</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lindsey-anthony</a10:uri><a10:email>anthony.lindsey@arnoldporter.com</a10:email></a10:author><title>The ICC’s 2026 Arbitration Rules: An Early Preview of the Changes (Part 2)</title><description>This article, Part 2, reviews the other significant changes made in the Rules and the practical effects these changes may have for parties, counsel, and arbitrators engaged in disputes at the ICC.</description><pubDate>Wed, 03 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The International Court of Arbitration of the International Chamber of Commerce (ICC) has announced its revised 2026 ICC Arbitration Rules (the Rules), which entered into force on June 1, 2026. Per the ICC, the amendments are aimed at enhancing transparency and efficiency in ICC proceedings, strengthening confidence in the arbitral process, and codifying several practices that have already developed under existing ICC case administration. &lt;/p&gt;
&lt;p&gt;The ICC published a series of preview articles highlighting key amendments and additions to the Rules in the lead up to their launch, and the Rules have now been published in their entirety. &lt;a href="/en/perspectives/advisories/2026/05/iccs-2026-arbitration-rules-an-early-preview-of-the-changes-pt-1"&gt;Part 1 of our Advisory&lt;/a&gt;&amp;nbsp;summarized the first set of early insights from the ICC and highlighted the implications for ICC arbitration practice. This article, Part 2, reviews the other significant changes made in the Rules and the practical effects these changes may have for parties, counsel, and arbitrators engaged in disputes at the ICC.&lt;/p&gt;
&lt;h2&gt;Highly Expedited Arbitration Provisions&lt;/h2&gt;
&lt;p&gt;Perhaps the most notable procedural innovation in the 2026 Rules is the introduction of an entirely new opt-in procedural track for parties seeking a streamlined and exceptionally swift resolution of their dispute: the Highly Expedited Arbitration Provisions (HEAP). HEAP is distinct from the ICC&amp;rsquo;s already existing Expedited Procedure Provisions (EPP), both in how these provisions can be applied to a particular dispute and in the even-more-streamlined procedures they contemplate.
&lt;/p&gt;
&lt;p&gt;Unlike the Expedited Procedure Provisions, HEAP cannot be applied by the ICC by default based on the amount in dispute. Rather, parties must expressly opt in to their application regardless of the monetary value of the claims. The ICC has stated that HEAP is appropriate for disputes of any size, provided the issues are sufficiently discrete and the parties share an interest in swift resolution. To opt in, parties may either incorporate HEAP in the arbitration agreement itself (a model HEAP clause is included in the 2026 Rules) or by agreement after a dispute has already arisen. &lt;/p&gt;
&lt;p&gt;The streamlined HEAP procedures call for adjudication by a sole arbitrator, which the parties have 20 days to nominate jointly; if they cannot agree within that period, the ICC Court directly appoints the arbitrator. Joinder and consolidation are not available in HEAP proceedings.&lt;/p&gt;
&lt;p&gt;The time limit for the sole arbitrator to render the award is three months from the initial case management conference, and the procedures require that conference to take place within seven days of the sole arbitrator&amp;rsquo;s receipt of the case file &amp;mdash; a significant compression from the 30-day window applicable in standard ICC proceedings, and even from the 15 days under the Expedited Procedure Provisions. The three-month award time limit includes ICC Court scrutiny and notification of the award to the parties. &lt;/p&gt;
&lt;p&gt;The ICC has emphasized, however, that HEAP should be understood as a distinct procedural track and not as standard ICC arbitration on a compressed timeline. The HEAP procedure is structured to require parties to frontload the presentation of their case and evidence, requiring the Statement of Claim to be filed with the Request for Arbitration, and a Statement of Defence to be filed with the Answer. The sole arbitrator has broad discretion to adopt procedural measures necessary to render the award within the time limit, which may include restrictions on further submissions and written witness statements, the exclusion of document production, and the determination of the dispute without a hearing.&lt;/p&gt;
&lt;p&gt;One of HEAP&amp;rsquo;s most novel features is the parties&amp;rsquo; ability to agree to an award without reasons, a marked departure from standard ICC practice. HEAP also adopts the same cost scale as the Expedited Procedure Provisions, with reduced tribunal fees.&lt;/p&gt;
&lt;p&gt;HEAP represents a genuine and significant expansion of the ICC&amp;rsquo;s procedural offerings, providing parties with a maximally streamlined option to resolve their dispute through arbitral procedures. Where time is of the essence, HEAP could serve as a powerful tool for parties to obtain meaningful and enforceable resolution of commercial disputes.&lt;/p&gt;
&lt;p&gt;At the same time, such highly expedited and streamlined arbitral procedures raise distinct considerations that parties should carefully evaluate. Parties opting in at the contract-drafting stage must consider whether the disputes likely to arise under the agreement are appropriate for HEAP&amp;rsquo;s truncated procedure and whether the frontloaded structure is feasible given the kinds of evidence that may need to be developed. To this end, parties may consider applying HEAP only to certain types or sizes of disputes, though inclusion of such carveouts bring separate risks should the parties disagree on their boundaries. &lt;/p&gt;
&lt;p&gt;Moreover, parties contemplating an award without reasons should pay particular attention to enforcement risk: although the ICC notes that only a &amp;ldquo;small number&amp;rdquo; of jurisdictions treat the absence of reasons as a ground for set-aside or refusal of enforcement, that population is not negligible and may include jurisdictions of practical importance to the parties in any given case. Counsel advising on the choice between HEAP, the EPP, and standard ICC arbitration will need to weigh these considerations carefully, particularly in circumstances where there may be uncertainty around the seat of arbitration or the jurisdictions in which enforcement of an award would occur.&lt;/p&gt;
&lt;h2&gt;Early Determination&lt;/h2&gt;
&lt;p&gt;Another significant step taken by the ICC in the 2026 Rules is formal codification of an early-determination procedure. Though the possibility of early determination has existed in ICC practice since 2017 &amp;mdash; through a reference to early determination contained in the ICC&amp;rsquo;s Note to Parties and Arbitral Tribunals on the Conduct of the Arbitration &amp;mdash; the ICC has now removed any remaining doubt about a tribunal&amp;rsquo;s authority to dispose of claims or defenses at an early stage of the proceedings and provided further guidance on how it may do so. The new rule, Article 30, states that:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;Any party may apply to the arbitral tribunal for the early determination of one or more claims or defences on the grounds that:&lt;br /&gt;
    &lt;span style="white-space: pre;"&gt;	&lt;/span&gt;a.&amp;nbsp;such claims or defences are manifestly without merit; or&lt;br /&gt;
    &lt;span style="white-space: pre;"&gt;	&lt;/span&gt;b.&amp;nbsp;such claims or defences are manifestly outside the arbitral tribunal&amp;rsquo;s jurisdiction.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;The arbitral tribunal shall determine in its discretion whether to allow the application to proceed. If the arbitral tribunal allows the application to proceed, it shall adopt the procedural measures it considers appropriate, after consulting the parties.
    &lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;The structure of Article 30 reflects a two-step decision: the tribunal first decides whether the application should be entertained at all, taking into account the stage of the proceedings and the need to ensure time and cost efficiency, and only then proceeds to the merits of the application itself. The ICC indicates that, in practice, tribunals have most often permitted early determination where the issues presented are purely legal and require no, or very limited, evidence, or the essential legal elements of a claim have not been pleaded. Comparatively, tribunals have generally rejected applications where resolution would require substantial legal or factual analysis. The underlying premise of the procedure is that the claim or defense fails as a matter of law even if the underlying factual allegations are assumed to be true.&lt;/p&gt;
&lt;p&gt;The ICC&amp;rsquo;s guidance regarding the new Article 30 provides that an early-determination decision may take the form of either a procedural order or an award, depending on its content. Decisions that finally dispose of claims will generally be expected to take the form of an award. This distinction has practical consequences: an award disposing of claims will be subject to ICC Court scrutiny (which the ICC indicates will typically occur within one week) and is, in turn, subject to enforcement and set-aside procedures in the relevant jurisdictions. Tribunals are expected to discuss the appropriate form of the decision with the parties in advance.&lt;/p&gt;
&lt;p&gt;The codification of early determination should encourage more frequent use of the procedure and reduce disputes over the appropriateness and governing standards for early determination. While the substantive standard (&amp;ldquo;manifestly without merit&amp;rdquo; or &amp;ldquo;manifestly outside the arbitral tribunal&amp;rsquo;s jurisdiction&amp;rdquo;) remains demanding, and the procedure is unlikely to dispose of disputes that turn on contested facts or contractual interpretation, parties facing claims or defenses that appear deficient as a matter of law can now confidently plan on submitting an application under Article 30 at the earliest possible stage. The ICC&amp;rsquo;s formal codification of early determination, as well as its provision for such determinations potentially being made via a scrutinized award, should enhance the usefulness of this tool. &lt;/p&gt;
&lt;h2&gt;Other Revisions&lt;/h2&gt;
&lt;p&gt;Finally, the 2026 Rules also introduce several other modest revisions, many of which codify existing ICC practice or make targeted adjustments to specific procedural mechanics. The most notable of these are summarized below:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Confidentiality&lt;/strong&gt;. New Article 12(8) imposes an express confidentiality obligation on arbitrators with respect to all matters relating to the arbitration, subject to standard exceptions for information already in the public domain, party agreement, applicable law, and the protection of legal rights. The 2026 Rules do not impose a default confidentiality obligation on the parties themselves; as under the prior Rules, the extent to which the arbitration as a whole is confidential remains a matter for party agreement and/or the law applicable to the arbitration.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Signature and notification of the award&lt;/strong&gt;. New Article 38 permits the tribunal, after consulting with the parties, to sign the award electronically or in counterparts, and to request that the ICC Secretariat notify the award in either paper or electronic form. This change accommodates the now-widespread practitioner preference for electronic execution and delivery and should meaningfully reduce delays previously associated with circulating awards for wet-ink signatures across jurisdictions, while preserving flexibility in jurisdictions with stricter rules around award format and certification.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Tribunal secretary&lt;/strong&gt;. New Article 44 codifies current ICC practice on the appointment of tribunal secretaries, expressly requiring that secretaries satisfy the same independence and impartiality standards as arbitrators and sign a corresponding statement before appointment. The Rules also clarify that secretaries work under the tribunal&amp;rsquo;s direction and control without delegation of decision-making authority, and that direct fee arrangements between the tribunal and the parties for secretary services are prohibited; secretaries&amp;rsquo; reasonable expenses may, however, be reimbursed under Appendix III.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Fees and costs&lt;/strong&gt;. The Schedule of Fees, including details of the fees and costs, is now incorporated directly into the 2026 Rules. Of note, the ICC has reduced administrative expenses for disputes under US$10 million. However, for the first time since 2010, the ICC has also introduced targeted upward adjustments for larger disputes, a development parties should factor into cost projections for high-value matters going forward.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Arnold &amp;amp; Porter has decades of experience serving as counsel in ICC disputes, as well as a number of partners who have served as arbitrators and in leadership roles at the ICC. For six years, above author and Practice Group Chair, Maria Chedid, served as one of the two U.S. members seated on the ICC Court of Arbitration. Please contact us if you face a dispute involving ICC proceedings, or if you are evaluating the inclusion of an ICC dispute-resolution clause in an agreement. We can provide expert representation drawing on our experience and in-depth knowledge of the ICC and international commercial arbitration practice more generally. &lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{3B804E10-ECE4-436C-821F-61CB0DBD2CB7}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/personal-care-products-council-2026-legal-and-regulatory-conference</link><author>raqiyyah.pippins@arnoldporter.com</author><title>Keeping Pace with Modern Marketing: Practical Claim Substantiation in the Age of AI and Influencers</title><pubDate>Wed, 03 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{CB2A7100-19FA-4D06-8D3F-DFA17A9B8DA5}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/06/the-expanding-frontier-product-liability-comes-for-ai-and-digital-platforms</link><a10:author><a10:name>Jason A. Ross</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/ross-jason-a</a10:uri><a10:email>jason.ross@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>David A. Kerschner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kerschner-david-a</a10:uri><a10:email>david.kerschner@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kristine Itliong</a10:name><a10:uri>https://www.arnoldporter.com/en/people/i/itliong-kristine</a10:uri><a10:email>kristine.itliong@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Rachel Lyons Forman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/forman-rachel</a10:uri><a10:email>rachel.forman@arnoldporter.com</a10:email></a10:author><title>The Expanding Frontier: Product Liability Comes for AI and Digital Platforms</title><description>Please join us for a discussion of the evolving product liability landscape affecting generative AI and digital platforms.</description><pubDate>Tue, 02 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Please join us for a discussion of the evolving product liability landscape affecting generative AI and digital platforms. Drawing on lessons from the social media bellwether trials and emerging lawsuits involving AI, online gaming, and prediction market platforms, our panel will examine how plaintiffs are adapting traditional product liability theories to modern digital products and where traditional defenses relating to causation, duty, and product liability remain strong.&lt;/p&gt;
&lt;p&gt;The discussion is relevant not only to AI developers and digital platforms but also to companies integrating generative AI into consumer-facing products and services.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;How plaintiffs are attempting to use product liability theories to challenge traditional defenses historically relied upon by digital platforms.&lt;/li&gt;
    &lt;li&gt;How emerging litigation theories may extend beyond platform developers to companies that deploy, integrate with, support, or commercially rely on AI systems, including enterprise users, service providers, and other ecosystem participants.&lt;/li&gt;
    &lt;li&gt;Key litigation themes, including alleged psychological harm causation challenges, internal document exposure, and parallels to prior mass-tort litigation.&lt;/li&gt;
    &lt;li&gt;Practical steps companies can take now to assess design risk, strengthen internal and external communications practices, and build litigation and reputational resilience before the litigation landscape hardens against them.&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{BE7B5463-8C9F-4754-8F25-107D516E9B61}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/arnold-porter-advises-d-e-shaw-ventures-in-anthropics-latest-65b-financing</link><title>Arnold &amp; Porter Advises D. E. Shaw Ventures in Anthropic’s Latest $65B Financing</title><description>Arnold &amp;amp; Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group&amp;rsquo;s venture capital and growth equity arm, in an investment in Anthropic as part of its $65 billion Series H financing.</description><pubDate>Tue, 02 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group&amp;rsquo;s venture capital and growth equity arm, in an investment in Anthropic as part of its $65 billion Series H financing. The funding round, which closed on May 28, values Anthropic at $965 billion post-money.&lt;/p&gt;
&lt;p&gt;This follows the firm&amp;rsquo;s &lt;a href="/en/perspectives/news/2026/05/arnold-porter-advises-d-e-shaw-ventures-on-openai-anthropic-investments"&gt;recent representation&lt;/a&gt;&amp;nbsp;of D. E. Shaw Ventures in its role as a co-lead in Anthropic&amp;rsquo;s $30 billion Series G financing round, as well as in several investments in OpenAI.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by partner Marina Richter and included partner Stephanie Coutu, senior associate Trevor Schmitt, and associate Anna Cardoso. Partners Deborah Curtis and Reuven Graber provided regulatory and tax advice, respectively.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1956DCD4-F9C4-4A79-B044-8B8B82ACDEBF}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/critical-deadline-approaching-for-taxpayers-entitled-to-relief-assessed-during-pandemic</link><a10:author><a10:name>Sarah Constantine</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/constantine-sarah-m</a10:uri><a10:email>sarah.constantine@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Rebecca L. D. Gordon</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gordon-rebecca-l-d</a10:uri><a10:email>Rebecca.Gordon@arnoldporter.com</a10:email></a10:author><title>Critical Deadline Approaching for Taxpayers Entitled to Relief From Penalties and Interest Assessed During Pandemic</title><description>A recent federal court decision in &lt;em data-start="35" data-end="59"&gt;Kwong v. United States&lt;/em&gt; may entitle millions of taxpayers to refunds or abatements of penalties and interest assessed during the COVID-19 pandemic. Taxpayers who paid late-filing, late-payment, or certain other tax penalties during the pandemic relief period should review their eligibility and consider filing refund, protective refund, or abatement claims before key deadlines, including July 10, 2026.</description><pubDate>Tue, 02 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;
&lt;p&gt;Taxpayers entitled to refunds or abatements of penalty amounts imposed during the COVID-19 pandemic must file claims for the refunds for which they are eligible by &lt;strong&gt;July 10, 2026&lt;/strong&gt;. This deadline may affect tens of millions of taxpayers eligible for refunds.&lt;/p&gt;
&lt;h2&gt;What to Know&lt;/h2&gt;
&lt;p&gt;Taxpayers who paid or were assessed late payment or late filing penalties during the COVID-19 disaster relief period, from January 20, 2020 to May 11, 2023, may be entitled to a refund or reduction of assessed penalties. Potentially affected taxpayers have until &lt;strong&gt;July 10, 2026&lt;/strong&gt; (three years plus 60 days after the end of the disaster period) to file a claim if their return was filed and tax was paid before July 10, 2023, and may have a later deadline if they paid the relevant tax on a later date. Taxpayers should promptly review their records and/or obtain a copy of their U.S. Internal Revenue Service (IRS) tax transcript to confirm whether they may be entitled to a refund or reduction of assessed penalties and interest and to ensure they do not miss a deadline. Taxpayers who cannot yet determine the amount of a formal refund request may nonetheless want to file a protective claim to preserve their rights. Taxpayers should reach out to their accountants or tax counsel to advise them on their rights to ensure this deadline is not missed.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;In &lt;em&gt;Kwong v. United States&lt;/em&gt;, 179 Fed. Cl. 382 (2025), the United States Court of Federal Claims ruled that Internal Revenue Code (IRC) &amp;sect; 7508A(d) served to toll the deadline for tax filings and payments during the COVID-19 pandemic (the Pandemic). The federal disaster declaration for the Pandemic was in place from January 20, 2020 to May 11, 2023. During the Pandemic, IRC &amp;sect; 7508A changed several times. Under the 2019 version of the statute, which Kwong argued should apply, the automatic extension period ran from the earliest date of the emergency until 60 days after the emergency ended. Kwong had been issued penalties for failing to pay his tax returns in a timely manner, and he argued that his three-year period to file a suit challenging his tax liabilities was timely because it was filed before July 10, 2023 &amp;mdash; or 60 days after the May 11, 2023 end date in the federal disaster declaration. The government argued that a later version of the statute, which limited the extension to 60 days after the declaration of the emergency, should apply. The court agreed with Kwong and found that, under IRC &amp;sect; 7508A(d), tax filing and payment deadlines were automatically extended for the entire federal disaster declaration period plus 60 days, or from January 20, 2020, to July 10, 2023.&lt;/p&gt;
&lt;h2&gt;Implications&lt;/h2&gt;
&lt;p&gt;Because the court in &lt;em&gt;Kwong&lt;/em&gt; interpreted IRC &amp;sect; 7508A(d) as mandating a &amp;ldquo;deadline pause&amp;rdquo; for the entire window of January 20, 2020, to July 10, 2023, taxpayers who paid failure-to-file or failure-to-pay penalties, estimated tax penalties, and associated interest incurred or accrued during that window may be eligible for a refund or abatement.&lt;/p&gt;
&lt;p&gt;Potentially tens of millions of taxpayers were assessed late filing and/or late payment penalties during the period in question. In the normal course, a taxpayer must file a claim for a credit or refund on the later of three years from the date their tax return was filed, or two years from the date they paid the tax. However, based on the court&amp;rsquo;s decision in &lt;em&gt;Kwong&lt;/em&gt;, returns and payments otherwise due during the disaster window would not have been due until July 10, 2023. This means that taxpayers who filed a late return during the pandemic, paid the tax due, and were assessed penalties or interest may be entitled to file a claim for credit or refund by filing on or before July 10, 2026 &amp;mdash; or their deadline may be extended even further depending on when they paid the penalties and interest at issue. Significantly, the &amp;ldquo;deadline pause&amp;rdquo; the court applied in &lt;em&gt;Kwong&lt;/em&gt; may also affect taxpayers who filed late international information returns even if no tax was due and were assessed penalties.&lt;/p&gt;
&lt;h2&gt;Types of Potential Claims&lt;/h2&gt;
&lt;p&gt;Taxpayers affected by the &lt;em&gt;Kwong&lt;/em&gt; decision should understand there are three types of claims or requests they could file to protect their rights. First, there is a refund claim, which is a request to the IRS to return money that has already been paid. Second, there is a protective refund claim, which asks the IRS to preserve the taxpayer&amp;rsquo;s right to a refund when (1) the taxpayer cannot yet determine the final amount, or (2) the taxpayer&amp;rsquo;s right to the refund is dependent on some future event (such as a legal development). Third, there is an abatement request, which applies if tax has been assessed but not yet paid; the taxpayer is asking the IRS to abate or remove all or part of the outstanding amount due.&lt;/p&gt;
&lt;h2&gt;What&amp;rsquo;s Next?&lt;/h2&gt;
&lt;p&gt;If you think you may be entitled to a &lt;em&gt;Kwong&lt;/em&gt;-related refund, consider which type of claim you may want or need to file.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Refund claims to adjust underlying tax liability are made on Form 1040, &lt;em&gt;U.S. Individual Income Tax Return&lt;/em&gt; (if the taxpayer has not yet filed their return), or Form 1040-X, &lt;em&gt;Amended U.S. Individual Income Tax Return&lt;/em&gt; (if the taxpayer needs to change a previously filed return). &lt;/li&gt;
    &lt;li&gt;A claim for a refund of interest or penalties or a claim for abatement should be made on Form 843, &lt;em&gt;Claim for Refund and Request for Abatement&lt;/em&gt;. Be sure to write &amp;ldquo;Protective Refund Claim Pursuant to Kwong Case&amp;rdquo; or similar language across the top of the Form 843, and clearly state that the request is based on the COVID-19 disaster relief period and cite the legal reasoning from &lt;em&gt;Kwong&lt;/em&gt;. Taxpayers should note that it is very important to file a &lt;strong&gt;separate&lt;/strong&gt; Form 843 for each period &lt;strong&gt;and&lt;/strong&gt; each type of tax. Additionally, Form 843 &lt;strong&gt;cannot be filed electronically&lt;/strong&gt; and should be sent by certified mail to the same IRS service center that processes your tax return to prove timely submission.&lt;/li&gt;
    &lt;li&gt;To strengthen any claim for refund, a taxpayer should include a copy of the taxpayer&amp;rsquo;s tax transcript with relevant entries identified if possible, a clear identification of penalty and interest amounts, copies of any IRS correspondence, and an explanation tying the penalties to the disaster relief period.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Arnold &amp;amp; Porter has the technical knowledge and expertise to assist clients in filing formal claims for refund, protective claims for refund, and requests for abatement. If you would like to discuss the &lt;em&gt;Kwong&lt;/em&gt; decision and how it may affect your right to file a claim for refund or abatement, please contact any of the authors of this Advisory or your usual Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;p&gt;* Micah Sperling contributed to this Advisory. Micah is employed as an associate in Arnold &amp;amp; Porter&amp;rsquo;s New York office.&lt;/p&gt;
&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{97EC052F-CECC-4D36-9587-4C2B3981719A}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/sec-proposes-to-rescind-climate-related-disclosure-rules</link><a10:author><a10:name>Sara Adler</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/adler-sara</a10:uri><a10:email>sara.adler@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Joel I. Greenberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/greenberg-joel-i</a10:uri><a10:email>joel.greenberg@arnoldporter.com</a10:email></a10:author><title>SEC Proposes to Rescind Climate-Related Disclosure Rules</title><description>On May 29, 2026, the SEC proposed to rescind amendments to its rules under the Securities Act and the Exchange Act that would require registrants to provide certain climate-related information in their registration statements and annual reports.</description><pubDate>Tue, 02 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On May 29, 2026, the SEC &lt;a rel="noopener noreferrer" href="https://www.sec.gov/files/rules/proposed/2026/33-11421.pdf" target="_blank"&gt;proposed&lt;/a&gt; to rescind amendments to its rules under the Securities Act and the Exchange Act that would require registrants to provide certain climate-related information in their registration statements and annual reports (Climate Rules).&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;The Climate Rules, which have not become effective (as described below), include many highly-prescriptive disclosure requirements, including, among others: (i) information about a registrant&amp;rsquo;s material climate-related risks; (ii) the governance and management of such risks; (iii) disclosure, when material, of a registrant&amp;rsquo;s greenhouse gas (GHG) emissions for accelerated filers and large accelerated filers (including attestation reports for registrants that are required to provide Scope 1 and/or Scope 2 emissions disclosure); (iv) information about internal carbon pricing; (v) scenario analysis; and (vi) specified disclosures related to severe weather events and other natural conditions in a note to a registrant&amp;rsquo;s audited financial statements.&lt;/p&gt;
&lt;p&gt;The Climate Rules are highly contentious, and almost immediately became subject to litigation. Various petitions were consolidated for review in the U.S. Court of Appeals for the Eighth Circuit, and on April 4, 2024, the SEC entered a stay of the Climate Rules pending the completion of the Eighth Circuit&amp;rsquo;s review. On March 27, 2025, the SEC voted to end its defense of the rules, and on September 12, 2025, the Eighth Circuit issued an Order holding the consolidated petitions for review in abeyance until the SEC reconsiders the challenged rules &amp;ldquo;by notice-and-comment rulemaking or renews its defense&amp;rdquo; of them. The Court noted that it was the SEC&amp;rsquo;s responsibility to determine whether the Climate Rules &amp;ldquo;will be rescinded, repealed, modified, or defended in litigation.&amp;rdquo; As a result, the Climate Rules remain stayed.&lt;/p&gt;
&lt;h2&gt;Recission Proposal&lt;/h2&gt;
&lt;p&gt;In its recission proposal, the SEC noted two independent reasons for recission of the Climate Rules. It has now determined that it did not have the statutory authority to adopt the Climate Rules in the first place, characterizing the Climate Rules as &amp;ldquo;a dramatic overreach of the Commission&amp;rsquo;s statutory authority.&amp;rdquo; It also stated that even if it had statutory authority to adopt the Climate Rules it should not have done so. The SEC includes a detailed discussion of additional rationales in support of its recession proposal, including that the Climate Rules: (i) are both unnecessary and inconsistent with the SEC&amp;rsquo;s &amp;ldquo;registrant-specific, materiality-based&amp;rdquo; disclosure regime; (ii) do not address investor protections, and thus go beyond the &amp;ldquo;legitimate policy concerns of the Federal securities laws&amp;rdquo;; (iii) require expenditures that &amp;ldquo;are not justified by the informational benefits they may provide to some investors&amp;rdquo;; and (iv) are inconsistent with the SEC&amp;rsquo;s &amp;ldquo;policy objectives of facilitating capital formation and promoting public company status.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Of course, recission of the Climate Rules does not eliminate any obligation to disclose climate-related matters that may exist under general disclosure standards.&lt;/p&gt;
&lt;p&gt;Comments are due within 60 days of publication in the Federal Register.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{377EA837-C813-4CDF-8AD2-76064A0B52DA}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/06/arnold-porter-welcomes-corporate-partner-lindsay-m-germano-in-denver</link><title>Arnold &amp; Porter Welcomes Corporate Partner Lindsay M. Germano in Denver</title><description>&lt;strong&gt;DENVER, June 1, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Lindsay M. Germano has joined the firm&amp;rsquo;s Corporate &amp;amp; Finance practice as a partner, resident in Denver.&amp;nbsp;</description><pubDate>Mon, 01 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;DENVER, June 1, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Lindsay M. Germano has joined the firm&amp;rsquo;s Corporate &amp;amp; Finance practice as a partner, resident in Denver. &lt;/p&gt;
&lt;p&gt;Ron Levine, co-chair of Arnold &amp;amp; Porter's Corporate &amp;amp; Finance practice and head of the firm's Denver office, said: &amp;ldquo;Lindsay brings more than two decades of experience advising on complex M&amp;amp;A, securities, and corporate governance matters &amp;ndash; the kind of sophisticated transactional work that is increasingly in demand as Denver continues to attract major corporate activity. Her deep roots in the local business community and her track record on high-stakes deals make her a natural fit to expand our practice in the region.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Lindsay joins the firm after serving in leadership positions at several public companies. She has led a broad range of corporate and strategic matters, including cross-border mergers and acquisitions, joint ventures, SEC filings, corporate governance, and executive compensation. Lindsay brings significant experience advising executives on legal risk and overseeing complex projects from diligence through execution and implementation. Her private practice background includes advising public and private companies, private equity funds, and their portfolio companies on sophisticated transactions.&lt;/p&gt;
&lt;p&gt;In joining the firm, Lindsay said: &amp;ldquo;Arnold &amp;amp; Porter's combined transactional, regulatory, and litigation strength enables the firm to serve clients at the highest level here in Denver, and I am eager to be joining the team as I return to private practice. Having spent years advising companies from the inside, I look forward to bringing that perspective to clients, both in Colorado and across the firm.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Lindsay earned her J.D. from Southern Methodist University Dedman School of Law and her B.A. from Rice University. &lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C22D7BA5-3D38-46EC-91EF-BB03676E7F87}</guid><link>https://www.biosliceblog.com/2026/06/virtual-and-digital-health-digest-may-2026/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><title>Virtual and Digital Health Digest – May 2026</title><pubDate>Mon, 01 Jun 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{F6C67A7A-0012-4112-8552-E4DA89A585D2}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/06/challenge-to-oregons-packaging-extended-producer-responsibility-law-and-other-legal-battles</link><a10:author><a10:name>Stacey Halliday</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/halliday-stacey</a10:uri><a10:email>stacey.halliday@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brandon W. Neuschafer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/neuschafer-brandon-w</a10:uri><a10:email>brandon.neuschafer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jennifer R. Kwapisz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kwapisz-jennifer-r</a10:uri><a10:email>jennifer.kwapisz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katrina R. Umstead</a10:name><a10:uri>https://www.arnoldporter.com/en/people/u/umstead-katrina</a10:uri><a10:email>katrina.umstead@arnoldporter.com</a10:email></a10:author><title>Challenge to Oregon’s Packaging Extended Producer Responsibility Law Races to Trial While Other Legal Battles Brew</title><description>States are increasingly adopting packaging extended producer responsibility laws that shift recycling and waste-management costs to producers, with Oregon, Colorado, and California emerging as key litigation battlegrounds. Pending challenges may shape how states structure EPR programs, including producer responsibility organization oversight, fee transparency, dispute rights, and compliance obligations for companies that make, distribute, sell, or use packaging.</description><pubDate>Mon, 01 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;
&lt;p&gt;Over the course of the last decade, a growing number of states have enacted &lt;a href="https://www.arnoldporter.com/en/perspectives/events/2026/02/extended-producer-responsibility-lessons-learned-and-whats-ahead" target="_self"&gt;extended producer responsibility (EPR) laws&lt;/a&gt;, which impose requirements for the end-of-life management of products like batteries, electronics, mattresses, and textiles. These laws generally shift responsibility for managing covered products at the end of their useful life from governments and taxpayers to the companies that place those products into the market. In the face of growing challenges over management of plastics and packaging waste, seven states &amp;mdash; Oregon, Colorado, California, Maine, Maryland, Minnesota, and Washington &amp;mdash; have enacted EPR laws targeting product packaging. Similar bills have been introduced in at least 10 additional states.&lt;/p&gt;
&lt;p&gt;Packaging EPR laws generally require companies that market, distribute, or sell packaged consumer products (&amp;ldquo;producers&amp;rdquo;) to pay fees meant to fund states&amp;rsquo; waste management and/or recycling programs, in theory shifting the costs of such programs from taxpayers and states to producers. States implementing these EPR programs have assigned the responsibility of assessing fees to non-governmental organizations, commonly referred to as producer responsibility organizations (PROs). Depending on the specific state&amp;rsquo;s requirements, producers may be required to join or form one of these organizations, which assess fees based on factors such as the type of materials in the producer&amp;rsquo;s packaging, the packaging&amp;rsquo;s recyclability, and the volumes of packaging attributed to the producer in the state.&lt;/p&gt;
&lt;p&gt;Packaging EPR laws have drawn criticism for both their fees and the PROs that set them. The laws tend to give PROs wide-ranging discretion to impose potentially exorbitant fees on a huge range of packaged products &amp;mdash; even where the wholesaler or distributor has no control over the packaging, and where such packaging is required to allow for safe shipping. Producers have decried the fee assessment process as non-transparent and the fees as arbitrary and potentially business-ending, particularly for small- and medium-sized companies. Further, many producers are forced to engage with a single state-approved PRO in which they have little input or insight. Through their contracts with producers, PROs may also restrict dispute resolution mechanisms to arbitration, leaving producers without the ability to challenge fee assessments through the courts or state administrative processes.&lt;/p&gt;
&lt;p&gt;Unsurprisingly, litigation challenging packaging EPR laws has quickly followed their implementation. At the core of the industry challenges are claims that these laws delegate too much fee-setting authority to private entities, provide too little transparency or review for producer assessments, and burden interstate commerce by shifting state-specific recycling costs onto companies operating through national and regional supply chains.&lt;/p&gt;
&lt;p&gt;Oregon&amp;rsquo;s packaging EPR law &amp;mdash; one of the first such programs to begin issuing producer invoices for PRO-assessed fees &amp;mdash; is headed to trial in federal court this July, following the grant of a preliminary injunction in February. While the preliminary injunction in that case bars enforcement of the law against the specific plaintiff association and its members, the court denied intervention by multiple similar organizations, who must now wait for the outcome of the July trial while Oregon barrels forward with enforcement against them. The case is the first merits test of how far states will be permitted to go in requiring companies to fund packaging and recycling programs administered through private PROs.&lt;/p&gt;
&lt;p&gt;Oregon is not the only battleground for packaging EPR laws. In Colorado, an industry group filed a lawsuit earlier this year challenging that state&amp;rsquo;s implementation of its packaging EPR program. In California, on the other hand, environmental groups have signaled their intent to challenge the state&amp;rsquo;s packaging EPR regulations as not being stringent enough, while a broad coalition of industry groups challenges the state&amp;rsquo;s &amp;ldquo;truth in recycling&amp;rdquo; law, which imposes strict limitations on representations that companies can make about their products&amp;rsquo; recyclability, with related implications for recycling targets set under California&amp;rsquo;s EPR scheme.&lt;/p&gt;
&lt;p&gt;This Advisory addresses the upcoming trial in Oregon and the brewing legal battles in Colorado and California. Together, these cases reflect the next phase of packaging regulation: The question is not whether states will pursue EPR mandates to address packaging disposal challenges, but rather how those programs must be structured to withstand legal scrutiny.&lt;/p&gt;
&lt;h2&gt;Oregon: The First Packaging EPR Trial&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h2&gt;
&lt;p&gt;In 2021, Oregon enacted the Plastic Pollution and Recycling Modernization Act. The law requires producers of covered product packaging, food service ware, paper goods, and other items to join or form a state-approved PRO, enter into a contract with the PRO, pay membership fees, and provide information about the materials used in the producer&amp;rsquo;s business and their volumes, which are then used to assess fees. The law defines producers to include manufacturers that sell packaged products in Oregon and wholesalers and distributors that bring such products into the state. Small producers &amp;mdash; generally defined as producers under $5 million in revenue or as responsible for under one metric ton of covered product &amp;mdash; are exempt. In addition to assessing fees, the PRO has the authority to establish incentives for, and to penalize, certain producers. Currently, Oregon&amp;rsquo;s only approved PRO is the Circular Action Alliance, a nonprofit organization specifically formed to administer packaging EPR programs. The Circular Action Alliance has also been approved to administer packaging EPR programs in six of the seven states with packaging EPR laws. The organization&amp;rsquo;s methodology for assessing fees has been designated confidential under a plan that Oregon approved. Contracts between producers and that PRO provide that fee assessments may only be challenged through binding arbitration. The Circular Action Alliance began issuing invoices to producers in May and June 2025, with payments beginning in July 2025.&lt;/p&gt;
&lt;p&gt;On July 30, 2025, the National Association of Wholesaler-Distributors (NAW), a trade association representing wholesalers and distributors conducting business across the United States, filed a &lt;a rel="noopener noreferrer" href="https://www.naw.org/naw-takes-legal-action-against-oregons-overreach-on-recycling-mandate/" target="_blank"&gt;lawsuit&lt;/a&gt; before the U.S. District Court for the District of Oregon, challenging Oregon&amp;rsquo;s packaging EPR program on constitutional grounds. The operative complaint named the director of the Oregon Department of Environmental Quality as the defendant and asserted claims under the federal dormant commerce clause, the state and federal due process clauses, the state and federal equal protection clauses, the federal doctrine of unconstitutional conditions, and the non-delegation doctrine under the Oregon Constitution.&lt;/p&gt;
&lt;p&gt;Specifically, the complaint alleged that the Oregon program violates the dormant Commerce Clause by discriminating against and unduly burdening out-of-state businesses, in favor of in-state producers. Plaintiff claims out-of-state businesses are subject to higher costs to try to adapt their systems and disaggregate their Oregon-bound products from other products in order to achieve compliance, in ways that in-state producers are not. Plaintiff further argues that the Oregon system creates inconsistent obligations that disrupt the uniformity of the national market, with disproportionate impacts on national or regional supply chains. Plaintiff claims that the law shifts Oregon-specific recycling costs onto wholesalers, distributors, and other companies operating through national and regional supply chains. Plaintiff also asserts that the program pressures companies to spread Oregon compliance costs across customers in other states and may operate as a practical barrier to bringing certain packaged goods into Oregon.&lt;/p&gt;
&lt;p&gt;The complaint further alleged that the program violates due process because it allows a nonprofit producer responsibility organization to play a central role in setting and assessing fees using a confidential fee methodology, and allows fee assessment challenges to be limited by contract to binding arbitration. In plaintiff&amp;rsquo;s view, those features leave regulated companies without meaningful notice of how fees are calculated or a meaningful opportunity for agency or judicial review.&lt;/p&gt;
&lt;p&gt;The complaint also asserted claims under the state and federal equal protection clauses, the federal unconstitutional-conditions doctrine, and the Oregon Constitution&amp;rsquo;s nondelegation doctrine. Those claims were based on allegations that the law disproportionately burdens certain wholesalers and distributors, conditions market access on participation in a private fee-setting regime, and delegates governmental authority to a private entity, respectively.&lt;/p&gt;
&lt;p&gt;Plaintiff ties these theories primarily to the program&amp;rsquo;s fee structure and administration. It alleges that forming an alternative PRO is prohibitively expensive and that invoices issued under Oregon&amp;rsquo;s program have been &amp;ldquo;shockingly high,&amp;rdquo; particularly for small- and medium-sized businesses. It further alleges that assessed fees sometimes exceed product margins and are imposed on distributors who lack control over packaging design or the ability to pass the fees on to those who do. Plaintiff describes the fees as effectively acting as a ban on certain products in Oregon, or as a penalty on packaging needed to transport goods in interstate commerce, &amp;ldquo;at the whim of a non-public entity.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In December 2025, Oregon moved to dismiss plaintiff&amp;rsquo;s claims for lack of subject matter jurisdiction and failure to state a claim. Specifically, it argued that the Eleventh Amendment of the U.S. Constitution deprives the federal court of jurisdiction to order state actors to comply with state law (i.e., the Oregon Constitution) and that plaintiff failed to plausibly allege its federal claims.&lt;/p&gt;
&lt;h3&gt;The Court&amp;rsquo;s Preliminary Injunction Ruling&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;In November 2025, plaintiff filed a motion seeking a preliminary injunction to bar the state from enforcing the Oregon packaging EPR law and its implementing regulations. At a February 6, 2026 hearing on the motion, the court&amp;rsquo;s questioning focused particularly on whether Oregon&amp;rsquo;s EPR program provides sufficient federal due process, given the central role that the private PRO plays in fee-setting and program administration. Counsel were asked about the confidentiality of the Circular Action Alliance&amp;rsquo;s fee methodology, the role of its board, the extent of Oregon&amp;rsquo;s oversight, the availability of agency or judicial review, and whether producers have a meaningful ability to understand and challenge their fee obligations.&lt;/p&gt;
&lt;p&gt;At the end of the hearing, the court &lt;a rel="noopener noreferrer" href="https://www.naw.org/naw-wins-preliminary-injunction-against-oregons-epr-law/" target="_blank"&gt;granted the motion&lt;/a&gt;, albeit issuing a preliminary injunction narrower than what plaintiff requested. The court enjoined Oregon from taking steps to enforce the act only as against the National Association of Wholesaler-Distributors and its members. (In a subsequent order, the court clarified that the injunction only applied to entities who were members as of the date that the preliminary injunction was entered.) In doing so, the court declined to find at this stage that plaintiff was likely to succeed on the merits. However, it nonetheless concluded that the case presented &amp;ldquo;serious questions&amp;rdquo; as to the merits of the claims, that plaintiff had shown likely irreparable harm in light of potentially expansive penalty fees, and that the balance of equities tipped &amp;ldquo;sharply&amp;rdquo; in plaintiff&amp;rsquo;s favor. The court noted that the balancing might be different, however, if the case were going to be delayed for a year or several years, as that might tip the equities more strongly toward the state. The court then set a July 13, 2026 trial date, ordering the parties to begin expedited discovery immediately.&lt;/p&gt;
&lt;p&gt;The court later denied motions to intervene filed by additional trade associations, explaining that intervention could delay the July trial and undermine the balance of equities supporting the preliminary injunction. In doing so, the court observed that these trade associations&amp;rsquo; interests would not be prejudiced: If Oregon were to prevail, the ruling would not have preclusive effect on non-parties. And if plaintiff was to prevail, the ruling would be to those trade associations&amp;rsquo; benefit.&lt;/p&gt;
&lt;p&gt;In April 2026, &lt;a rel="noopener noreferrer" href="https://www.jdsupra.com/legalnews/oregon-calls-out-noncompliant-producers-9444968/" target="_blank"&gt;Oregon stepped up its enforcement efforts&lt;/a&gt; against producers that have not yet met the law&amp;rsquo;s requirements, issuing a &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fstatic1.squarespace.com%2Fstatic%2F64260ed078c36925b1cf3385%2Ft%2F69d903d0c3c096784a3aeb66%2F1775829968918%2FRMA%2BQuarterly%2BProducer%2BStatus%2BList_as%2Bof%2B4-9-2026.pdf&amp;amp;data=05%7C02%7CJennifer.Kwapisz%40arnoldporter.com%7C42c7f28125c9463c6e3608dea602e3ed%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639130728508816580%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=BBtNn1kLGFjzOtU%2BDpJEV5YRNAbJyskP%2Fupsntc47j8%3D&amp;amp;reserved=0" target="_blank"&gt;list of allegedly noncompliant producers&lt;/a&gt; on April 10, 2026, and sending warning letters threatening penalties for noncompliance. Noncompliance under the law includes fines of up to $25,000 per day per violation.&lt;/p&gt;
&lt;h3&gt;The Court&amp;rsquo;s Ruling on Oregon&amp;rsquo;s Motion to Dismiss&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;At the February 6 hearing, the court also granted in part and denied in part Oregon&amp;rsquo;s motion to dismiss the Amended Complaint. The court denied the motion as to NAW&amp;rsquo;s claims under the federal dormant commerce clause and federal due process clause, finding those claims had been plausibly alleged. Those claims will go to trial in July.&lt;/p&gt;
&lt;p&gt;The court granted the motion with respect to the remainder of plaintiff&amp;rsquo;s claims. The court dismissed the state law claims, agreeing with Oregon that the Eleventh Amendment bars such claims against a state from being heard in federal court. Importantly, the court did not find that a nondelegation theory inherently lacks merit; rather, the ruling simply underscores that such claims may need to be brought in state court, which the court noted during the February 6 hearing.&lt;/p&gt;
&lt;p&gt;The court also dismissed the federal equal protection claim, which was premised on the argument that mid-sized wholesalers and distributors were being disproportionately burdened by the Oregon packaging EPR law, while smaller producers were treated as exempt and larger producers stood to benefit from the law&amp;rsquo;s incentive structures. Although the court did not elaborate on its reasoning, the dismissal suggests that equal protection may add little where the core challenge to an EPR law is about interstate commerce, private fee-setting, and due process, rather than differential treatment of covered producers. Moreover, as Oregon argued in its motion to dismiss, and plaintiff conceded, the equal protection challenge was subject only to rational basis review &amp;mdash; a low bar.&lt;/p&gt;
&lt;p&gt;The court dismissed the unconstitutional conditions claim without prejudice. Plaintiff argued that the Oregon packaging EPR law impermissibly conditioned access to the Oregon market and the receipt of incentives on producers&amp;rsquo; agreement to relinquish core constitutional rights through their contracts with the Circular Action Alliance. The court indicated that it was skeptical that plaintiff could plead a specific unconstitutional condition since plaintiff&amp;rsquo;s members &amp;ldquo;arguably could form their own PRO,&amp;rdquo; but allowed plaintiff an opportunity to attempt to replead. The court further observed that the theory appeared to stand or fall with the due process and dormant commerce clause claims. Plaintiff ultimately declined to replead the claim.&lt;/p&gt;
&lt;h3&gt;Issues to Watch at Trial&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;The July trial in Oregon may provide an early merits ruling on issues likely to recur as packaging EPR programs move from enactment to implementation. NAW&amp;rsquo;s claims raise questions of first impression about the degree of transparency required when states authorize PROs to assess fees, the procedural mechanisms that should be required to allow producers to weigh in and challenge fee assessments by PROs, and the impact of packaging EPR laws on commerce as a broad array of manufacturers, wholesalers, and distributors are subjected to these laws. Underlying these issues is the question of how much authority states may assign to private or nonprofit PROs that collect data, set budgets, assess fees, and contract for waste disposal services, and with what level of oversight. A ruling for NAW could prompt states to revisit PRO governance, agency oversight, fee-setting transparency, and appeal rights. For producers directly impacted by the Oregon packaging EPR program, the ruling could determine not only whether they remain subject to the fees that Oregon has imposed and continues to impose, but as a practical matter, whether they are able to continue to operate within the state or operate at all.&lt;/p&gt;
&lt;p&gt;Under the court&amp;rsquo;s May 28, 2026 amended trial-management schedule, several key pretrial deadlines are approaching. The parties&amp;rsquo; statements of the case and joint status report identifying issues for the pretrial conference are due June 26, 2026. The pretrial conference is scheduled for July 1. Motions in limine are due July 3, with responses due July 6. These filings likely will provide additional insights as to the parties&amp;rsquo; theories of the case and how these theories are to be presented at trial.&lt;/p&gt;
&lt;h2&gt;Colorado: Similar Challenges to PRO-Managed EPR Program&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h2&gt;
&lt;p&gt;In 2022, Colorado enacted its own packaging EPR law, the Producer Responsibility Program for Statewide Recycling Act. The Colorado EPR program is similar to Oregon&amp;rsquo;s in its designation of a state-approved PRO to assess fees for producers of covered packaging and paper products. Also, like Oregon, the Circular Action Alliance has been selected as Colorado&amp;rsquo;s PRO. Colorado&amp;rsquo;s law provides that additional PROs may not be considered until at least January 1, 2029. The act does allow producers to submit &amp;ldquo;individual program plan proposals&amp;rdquo; to the state which, if approved, allow producers to assume responsibility to comply with the act individually.&lt;/p&gt;
&lt;p&gt;In March 2026, the Independent Lubricant Manufacturers Association, a national trade association of independent lubricant producers and wholesale distributors, &lt;a rel="noopener noreferrer" href="https://ilma.org/ilma-files-lawsuit-to-protect-independent-lubricant-manufacturers/" target="_blank"&gt;filed a lawsuit&lt;/a&gt; in Colorado state court challenging the Colorado Department of Public Health and Environment&amp;rsquo;s implementation of the EPR law as applied to non-lubricant and lubricant packaging. With respect to non-lubricant packaging, the complaint raises many of the same challenges to the Circular Action Alliance and its fee assessment process that have been raised in Oregon. The complaint also alleges that Colorado illegally approved an individual program plan proposal from the Lubricants Packaging Management Association and then required producers of petroleum and automotive products to register with that association, making such producers subject to the association&amp;rsquo;s reporting requirements and fees assessments. According to the complaint, that entity effectively operates as an additional producer responsibility organization, despite the statutory restriction on considering additional producer responsibility organizations before 2029, and was formed by larger industry participants that compete with the plaintiff association&amp;rsquo;s members.&lt;/p&gt;
&lt;p&gt;The operative complaint alleges that the Colorado program unlawfully shifts regulatory authority from the state to private entities. It alleges that the state&amp;rsquo;s program violates the due process clauses of the state and federal constitutions and the nondelegation doctrine of the state constitution, and that the state acted unlawfully in approving the Lubricants Packaging Management Association to issue fees and in enforcing fees assessed by that association and the Circular Action Alliance. These claims echo themes from the Oregon litigation, including challenges to mandatory contracting with private entities, lack of a meaningful process for fee review, fees disconnected from state-specific recycling costs, and disproportionate impacts on small- and mid-sized companies. (The complaint discusses the Oregon claims and the federal court&amp;rsquo;s grant of NAW&amp;rsquo;s preliminary injunction in the Oregon case.) In addition, plaintiff asserts a distinct First Amendment claim, challenging provisions of the Colorado act that prohibit producers from charging point-of-sale or point-of-collection fees to consumers to recoup EPR compliance costs. The complaint alleges that this restriction limits producers&amp;rsquo; ability to communicate the cost of the program to customers and may encourage cost-spreading outside Colorado in states that will receive no benefit from Colorado&amp;rsquo;s planned recycling programs.&lt;/p&gt;
&lt;p&gt;The Colorado Department of Public Health and Environment recently moved to dismiss the complaint. The department argues that plaintiff&amp;rsquo;s statutory claims are untimely because plaintiff did not seek judicial review within the Administrative Procedure Act&amp;rsquo;s 35-day window for challenging final agency action. It also argues that the constitutional claims fail on the merits because plaintiff has not identified a protected property interest sufficient to support the due process claim, the act&amp;rsquo;s detailed plan requirements and the department&amp;rsquo;s ongoing oversight foreclose the nondelegation claim, and the point-of-sale fee provision regulates conduct rather than speech and thus does not run afoul of the First Amendment. Finally, the department argues that the case should be dismissed, or joinder ordered, because plaintiff failed to join Circular Action Alliance and the Lubricants Packaging Management Association as necessary parties. That motion remains pending as of writing. The court&amp;rsquo;s ruling may provide early insight into how other courts are likely to evaluate constitutional challenges to packaging EPR programs outside of Oregon, including due process and nondelegation claims.&lt;/p&gt;
&lt;h2&gt;California: Challenges From Multiple Directions&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h2&gt;
&lt;p&gt;On May 1, 2026, California approved regulations implementing its packaging EPR law, the Plastic Pollution Prevention and Packaging Producer Responsibility Act, also known as SB 54. The act requires producers to participate in an approved PRO plan or submit an independent producer application. The Circular Action Alliance has been approved to serve as the state&amp;rsquo;s first PRO.&lt;/p&gt;
&lt;p&gt;California SB 54 is distinctive, however, in that it combines the PRO structure with statewide substantive performance mandates, including source-reduction targets, recycling-rate targets, and a 2032 requirement that covered single-use packaging and plastic food service ware be recyclable or compostable. In addition to Oregon-style challenges to PRO fee-setting and private administration of the EPR program, California may also face challenges related to these targets and requirements as well. For example, SB 54&amp;rsquo;s mandates may raise questions about whether the regulations go too far, or not far enough, in implementing the statute&amp;rsquo;s reduction and recycling goals; whether compliance pathways are feasible for producers subject to the law; and whether state-specific packaging requirements impose practical burdens on national packaging and distribution systems.&lt;/p&gt;
&lt;p&gt;California&amp;rsquo;s EPR program is already facing the prospect of litigation in the near term, but at least initially from a different direction than in other states. &lt;a rel="noopener noreferrer" href="https://www.nrdc.org/press-releases/environmental-advocates-challenge-plastics-regulations-court" target="_blank"&gt;Environmental groups&lt;/a&gt; have announced plans to challenge California&amp;rsquo;s new EPR program&amp;rsquo;s implementing regulations, arguing that the regulations create loopholes that undermine the act&amp;rsquo;s plastic reduction and recycling goals.&lt;/p&gt;
&lt;p&gt;In addition, SB 54 incorporates California&amp;rsquo;s &amp;ldquo;truth in recycling&amp;rdquo; framework under SB 343 for purposes of determining which covered material categories are deemed &amp;ldquo;recyclable in the state.&amp;rdquo; Under SB 54, California&amp;rsquo;s Department of Resources Recycling and Recovery (CalRecycle) must publish and update lists of covered material categories that are recyclable or compostable, and recyclability determinations are tied to Public Resources Code section 42355.51, a provision of SB 343. In March 2026, a broad coalition of industry groups filed a lawsuit challenging SB 343, including Public Resources Code section 42355.51, in the U.S. District Court for the Southern District of California. Plaintiffs argue that SB 343&amp;rsquo;s criteria for what is considered recyclable in the state are ambiguous and difficult to apply, depriving businesses of notice as to what is considered recyclable or not. Plaintiffs have sought a preliminary injunction to halt enforcement of the law while the case proceeds, and the court heard argument on the motion on June 3, 2026. This litigation could have practical implications for SB 54 even though it does not directly challenge the EPR program, as it may affect how CalRecycle classifies covered material categories, how producers evaluate compliance with SB 54&amp;rsquo;s recyclability requirements, and how companies approach packaging design and labeling for the California market.&lt;/p&gt;
&lt;h2&gt;What Companies Should Watch&lt;span style="font-size: 13px;"&gt;&lt;/span&gt;&lt;/h2&gt;
&lt;p&gt;Companies that produce, distribute, sell, import or use packaging in Oregon, Colorado, California, and other states with EPR laws should monitor packaging EPR litigation closely. The first packaging EPR trial in Oregon will not answer every question, but it may establish important guideposts for how states may structure packaging EPR programs, and how implicated companies can prepare for a regulatory landscape that is becoming more complex, expensive, and contested. The litigation may affect not only the validity of specific state programs, but also the design of future EPR laws and the obligations placed on regulated entities.&lt;/p&gt;
&lt;p&gt;Implementation milestones in other states may also become pressure points for additional litigation. Maine is worth watching because, like Oregon, it is one of the earliest states to adopt a packaging EPR law and is now moving from program design toward implementation; its final program rules were adopted in 2024, and the program will move into full operation in 2027. Faced with impending invoices for PRO-assessed fees, companies may face the same kinds of decisions now playing out in Oregon, including whether to reserve rights while attempting to comply, to attempt to seek administrative relief, or to pursue litigation. Oregon also underscores that enforcement may continue while litigation is pending absent a court order or standstill agreement providing otherwise, and that any relief may be limited to the parties before the court. Companies pursuing litigation may need to be prepared to proceed on an expedited track to obtain interim relief. Further, those considering a formal adversarial posture also would be well-advised to consider whether their compliance conduct, agency and PRO communications, public statements, and reservation-of-rights language are consistent with the arguments they may later need to make about irreparable harm, inadequate remedies, or the practical burdens of compliance.&lt;/p&gt;
&lt;p&gt;In the near term, companies should consider reviewing state-by-state covered-material obligations under existing and proposed packaging EPR laws, preserving records supporting fee calculations and supply-chain assumptions, evaluating contractual provisions for EPR cost allocation and indemnity, and assessing whether positions on recyclability remain defensible under evolving labeling rules.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{211695CB-163D-4BF9-9982-D4F716C3EB09}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/sec-proposes-amendments-to-the-registered-offering-and-public-company-reporting-framework</link><a10:author><a10:name>Christopher DeCresce</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/decresce-christopher</a10:uri><a10:email>Chris.DeCresce@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Robert C. Azarow</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/azarow-robert-c</a10:uri><a10:email>robert.azarow@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher P. Peterson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/peterson-christopher-p</a10:uri><a10:email>christopher.peterson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Michael Penney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/penney-michael</a10:uri><a10:email>michael.penney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sara Adler</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/adler-sara</a10:uri><a10:email>sara.adler@arnoldporter.com</a10:email></a10:author><title>SEC Proposes Significant Amendments to the Registered Offering and Public Company Reporting Framework</title><description>The U.S. Securities and Exchange Commission has proposed sweeping amendments that could significantly reshape registered offerings and public company reporting obligations. If adopted, the changes would expand access to Form S-3 and shelf registration, simplify filer classifications, and reduce compliance burdens for many issuers &amp;mdash; particularly smaller, newly public, and emerging growth companies.</description><pubDate>Mon, 01 Jun 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;h2&gt;Summary&lt;/h2&gt;
&lt;p&gt;On May 19, 2026, the U.S. Securities and Exchange Commission (SEC) proposed significant amendments to the registered offering and public company reporting framework that, if adopted, would represent the most substantial modernization of the capital markets regulatory regime since the Jumpstart Our Business Startups Act (JOBS Act).&lt;/p&gt;
&lt;p&gt;The proposals are intended to expand access to capital markets, simplify filer classifications, and reduce compliance burdens for reporting companies. Key proposed changes include expanded Form S-3 eligibility, broader access to shelf registration and offering communication accommodations, modernization of Form S-1 incorporation by reference rules, and increased flexibility relating to financial statement requirements.&lt;/p&gt;
&lt;p&gt;The SEC also proposed major revisions to the filer status framework, including increasing the large accelerated filer threshold from $700 million to $2 billion, eliminating the accelerated filer and smaller reporting company categories, and exempting most non-accelerated filers from the auditor attestation requirements under Section 404(b) of the Sarbanes-Oxley Act.&lt;/p&gt;
&lt;p&gt;If adopted, the proposals could significantly affect capital raising strategies, disclosure obligations, and public company compliance costs, particularly for smaller issuers, emerging growth companies, and newly public companies.&lt;/p&gt;
&lt;h3&gt;I.&amp;nbsp; Expansion of Form S-3 Eligibility&lt;/h3&gt;
&lt;p&gt;One of the most consequential aspects of the proposal is the SEC&amp;rsquo;s effort to broaden access to Form S-3 registration statements for issuers. Under the proposed amendments, issuers would no longer be required to have been subject to the Securities Exchange Act of 1934 (Exchange Act) reporting obligations for at least 12 months before becoming eligible to use Form S-3 (referred to as the &amp;ldquo;seasoning rule&amp;rdquo;). The proposal eliminates certain transaction-based limitations currently embedded in Form S-3, including the requirement that issuers maintain at least $75 million in public float in order to register unlimited primary offerings.&lt;/p&gt;
&lt;p&gt;Issuers would still be required to remain current in their Exchange Act reporting obligations and would continue to be subject to the existing &amp;ldquo;ineligible issuer&amp;rdquo; framework.&lt;/p&gt;
&lt;p&gt;If adopted, these changes could significantly increase the number of issuers able to conduct shelf offerings and other capital raises through Form S-3, thereby enhancing financing flexibility for companies seeking access to recurring capital.&lt;/p&gt;
&lt;h3&gt;II.&amp;nbsp; Extension of Shelf Registration and Communication Flexibilities&lt;/h3&gt;
&lt;p&gt;The proposal would also expand several offering-related benefits that are currently reserved primarily for well-known seasoned issuers (WKSIs).&lt;/p&gt;
&lt;p&gt;Under the proposed framework, issuers that are Form S-3 eligible and maintain a class of common equity listed on a national securities exchange would become eligible for greater flexibility in offering communications and expanded access to streamlined shelf registration processes. Automatic shelf registration (ASR) would remain limited to issuers with at least 12 months of Exchange Act reporting history. However, the size requirements for ASR eligibility (generally determined by non-affiliate public equity float or the principal amount of non-convertible debt outstanding) would be eliminated.&lt;/p&gt;
&lt;p&gt;According to the SEC, the proposed revisions could materially increase the number of issuers eligible to utilize these streamlined offering mechanisms.&lt;/p&gt;
&lt;h3&gt;III.&amp;nbsp; Modernization of Form S-1 Incorporation by Reference&lt;/h3&gt;
&lt;p&gt;The SEC also proposes modernizing Form S-1 by significantly expanding the ability of issuers to incorporate previously filed information by reference in follow-on offerings. For example, former blank check reporting companies, which include companies that went public via a &amp;ldquo;deSPAC&amp;rdquo; merger, are currently restricted in their ability to incorporate Exchange Act reports into Form S-1 registration statements. The proposed amendments would permit broader &amp;ldquo;forward incorporation&amp;rdquo; and &amp;ldquo;backward incorporation&amp;rdquo; practices on par with S-3 issuers. As a practical matter, these revisions could reduce duplicative disclosure obligations and lower drafting and compliance costs for issuers conducting registered offerings or resale registration obligations under Form S-1.&lt;/p&gt;
&lt;h3&gt;IV.&amp;nbsp; Federal Preemption of State Registration Requirements&lt;/h3&gt;
&lt;p&gt;Another notable proposal would define &amp;ldquo;qualified purchaser&amp;rdquo; under Section 18(b)(3) of the Securities Act in a manner that would preempt state securities law registration and qualification requirements for all registered offerings, including offerings involving unlisted securities. Currently, federal preemption exists only for securities listed on a national exchange. The proposal is intended to streamline offering compliance by reducing the need for issuers to navigate separate state-level securities registration regimes.&lt;/p&gt;
&lt;h3&gt;V.&amp;nbsp; Financial Statement Timing Flexibility&lt;/h3&gt;
&lt;p&gt;The SEC additionally proposes revisions that would eliminate certain income-based restrictions affecting the timing of audited financial statement inclusion in registration statements and proxy materials.&lt;/p&gt;
&lt;p&gt;Smaller reporting companies and certain reporting issuers would receive expanded flexibility regarding when audited annual financial statements must be included in offering materials. The SEC has indicated that the amendments are intended to reduce transactional delays and compliance costs associated with securities offerings.&lt;/p&gt;
&lt;h2&gt;Proposed Revisions to Filer Status Framework&lt;/h2&gt;
&lt;h3&gt;I.&amp;nbsp; Increase to Large Accelerated Filer Thresholds&lt;/h3&gt;
&lt;p&gt;The SEC&amp;rsquo;s second proposal focuses on restructuring the filer status regime applicable to reporting companies. The SEC proposes increasing the public float threshold for large accelerated filer (LAF) status from $700 million to $2 billion, and companies would be required to satisfy the threshold for two consecutive years.&lt;/p&gt;
&lt;p&gt;The proposal would also require companies to have at least 60 months of Exchange Act reporting history before qualifying as LAFs, effectively creating a five-year transition period for newly public companies, regardless of the size of the public float or any other measurement. Significantly, once eligible for LAF status, the ongoing annual year-end evaluation and determination of LAF status at the end of the most recently completed second fiscal quarter would be eliminated. Taken together, these revisions are intended to create greater stability and predictability in filer status determinations while reducing regulatory burdens for issuers experiencing temporary fluctuations in market capitalization.&lt;/p&gt;
&lt;h3&gt;II.&amp;nbsp; Simplification of Filer Categories&lt;/h3&gt;
&lt;p&gt;The SEC further proposes eliminating the accelerated filer and smaller reporting company (SRC) categories altogether.&lt;/p&gt;
&lt;p&gt;Under the revised framework, issuers generally would be classified either as large accelerated filers or non-accelerated filers (NAF). Importantly, NAFs would continue to benefit from many accommodations currently available to SRCs and emerging growth companies, including scaled executive compensation disclosure requirements and reduced financial statement obligations.&lt;/p&gt;
&lt;h3&gt;III.&amp;nbsp; Auditor Attestation Relief&lt;/h3&gt;
&lt;p&gt;One of the most impactful aspects of the proposal is the SEC&amp;rsquo;s treatment of internal control attestation requirements.&lt;/p&gt;
&lt;p&gt;Under the proposed amendments, NAFs would not be required to obtain an independent auditor attestation regarding internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act.&lt;/p&gt;
&lt;p&gt;For many reporting companies, this change could substantially reduce annual compliance costs associated with public company reporting obligations.&lt;/p&gt;
&lt;h3&gt;IV.&amp;nbsp; New &amp;ldquo;Small NAF&amp;rdquo; Category&lt;/h3&gt;
&lt;p&gt;The proposal would also establish a new category of &amp;ldquo;small non-accelerated filers&amp;rdquo; for companies with total assets of $35 million or less over the preceding two fiscal years. These issuers would receive additional time to file periodic reports, including extended deadlines for both Form 10-K and Form 10-Q filings.&lt;/p&gt;
&lt;h2&gt;Practical Considerations and Next Steps&lt;/h2&gt;
&lt;p&gt;The proposals remain subject to a 60-day public comment period and may be revised prior to adoption. Nevertheless, public companies and companies preparing for public offerings should begin evaluating the potential implications of the proposed rule changes.&lt;/p&gt;
&lt;p&gt;In particular, issuers should assess whether the proposals could:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Expand eligibility for Form S-3 or shelf registration&lt;/li&gt;
    &lt;li&gt;Improve access to at-the-market or follow-on offerings&lt;/li&gt;
    &lt;li&gt;Reduce public company compliance costs&lt;/li&gt;
    &lt;li&gt;Affect disclosure controls and reporting timelines&lt;/li&gt;
    &lt;li&gt;Alter long-term capital markets planning strategies&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Until final rules are adopted, companies should continue operating under the current regulatory framework while monitoring developments in the SEC rulemaking process. In particular, issuers should pay close attention to the reaction of the investor community to these proposals.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{5FA76BDA-E793-4187-B962-AE7722375FDB}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/iam-patent-1000-2026-recognizes-arnold-porters-patent-capabilities</link><title>IAM Patent 1000 2026 Recognizes Arnold &amp; Porter’s Patent Capabilities</title><description>The 15th edition of the &lt;em&gt;IAM Patent 1000 &amp;mdash; The World&amp;rsquo;s Leading Patent Professionals&lt;/em&gt; recognized 15 Arnold &amp;amp; Porter lawyers over seven jurisdictions for their outstanding patent work across the United Kingdom, United States, and internationally.</description><pubDate>Fri, 29 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The 15th edition of the &lt;em&gt;IAM Patent 1000 &amp;mdash; The World&amp;rsquo;s Leading Patent Professionals&lt;/em&gt; recognized 15 Arnold &amp;amp; Porter lawyers over seven jurisdictions for their outstanding patent work across the United Kingdom, United States, and internationally. Arnold &amp;amp; Porter was also included in the guide&amp;rsquo;s &amp;ldquo;International&amp;rdquo; list of 35 firms. &lt;em&gt;The IAM Patent 1000&lt;/em&gt; guide &amp;ldquo;shines a spotlight on the firms and individuals that are deemed outstanding in the pivotal area of patent law.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter received the following firm rankings in the 2026&lt;em&gt; IAM Patent 1000&lt;/em&gt; guide:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;International&amp;mdash;Recommended&lt;/li&gt;
    &lt;li&gt;Litigation&amp;mdash;Silver (California)&lt;/li&gt;
    &lt;li&gt;Litigation&amp;mdash;Silver (D.C. Metro Area)&lt;/li&gt;
    &lt;li&gt;Litigation&amp;mdash;Silver (Illinois)&lt;/li&gt;
    &lt;li&gt;Litigation&amp;mdash;Silver (New York)&lt;/li&gt;
    &lt;li&gt;Litigation&amp;mdash;Silver (United States: National)&lt;/li&gt;
    &lt;li&gt;Prosecution&amp;mdash;Recommended (D.C. Metro Area)&lt;/li&gt;
    &lt;li&gt;Transactions&amp;mdash;Recommended (New York)&lt;/li&gt;
    &lt;li&gt;Transactions&amp;mdash;Gold (United Kingdom: England and Wales)&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The following lawyers were recognized in the 2025 &lt;em&gt;IAM Patent 1000&lt;/em&gt; guide:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Daniel DiNapoli&amp;mdash;Silver: Litigation (New York)&lt;/li&gt;
    &lt;li&gt;Deborah Fishman&amp;mdash;Recommended: Life Sciences Prosecution (United States: National); Gold: Litigation (California)&lt;/li&gt;
    &lt;li&gt;Michael Harris&amp;mdash;Bronze: Litigation (Illinois)&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Dina Hayes&amp;mdash;Silver: Litigation (Illinois)&lt;/li&gt;
    &lt;li&gt;Thomas Magnani&amp;mdash;Recommended: Transactions (California)&lt;/li&gt;
    &lt;li&gt;David Marsh&amp;mdash;Highly Recommended: Prosecution (D.C. Metro)&lt;/li&gt;
    &lt;li&gt;Daniel Reisner&amp;mdash;Silver: Litigation (New York)&lt;/li&gt;
    &lt;li&gt;Christopher Renk&amp;mdash;Bronze: Litigation (Illinois)&lt;/li&gt;
    &lt;li&gt;Evan Rothstein&amp;mdash;Silver: Litigation (Colorado)&lt;/li&gt;
    &lt;li&gt;Beatriz San Martin&amp;mdash;Bronze: Litigation (United Kingdom: England &amp;amp; Wales)&lt;/li&gt;
    &lt;li&gt;Ali Sharifahmadian&amp;mdash;Bronze: Litigation (D.C. Metro Area)&lt;/li&gt;
    &lt;li&gt;Aaron Stiefel&amp;mdash;Silver: Litigation (New York)&lt;/li&gt;
    &lt;li&gt;Ewan Townsend&amp;mdash;Highly Recommended: Transactions (United Kingdom: England &amp;amp; Wales)&lt;/li&gt;
    &lt;li&gt;Tom Wilson&amp;mdash;Next Generation: Recommended (United Kingdom: England and Wales)&lt;/li&gt;
    &lt;li&gt;Matthew Wolf&amp;mdash;Recommended: Court of Appeals for the Federal Circuit (United States: National); Gold: Litigation (D.C. Metro Area)&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{D78165FF-C240-45D1-A4A8-3689C6D722AC}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/corporate-criminal-liability-expanded-to-all-crimes-under-the-crime-and-policing-act-2026</link><a10:author><a10:name>Kathleen Harris</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/harris-kathleen</a10:uri><a10:email>kathleen.harris@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sean Curran</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/curran-sean</a10:uri><a10:email>sean.curran@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Maya Paunrana</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/paunrana-maya</a10:uri><a10:email>maya.paunrana@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Melissa Dames</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/dames-melissa</a10:uri><a10:email>melissa.dames@arnoldporter.com</a10:email></a10:author><title>Corporate Criminal Liability Expanded to All Crimes Under the Crime and Policing Act 2026</title><description>The UK Crime and Policing Act 2026 significantly expands corporate criminal liability by making companies potentially liable for any criminal offense committed by senior managers acting within the scope of their authority, extending beyond the economic crimes covered by the Economic Crime and Corporate Transparency Act 2023. Effective June 29, 2026, the Act is expected to increase corporate enforcement activity and underscores the need for businesses to review governance, compliance, and whistleblowing frameworks, identify individuals who may qualify as senior managers, and strengthen training and risk management measures.</description><pubDate>Fri, 29 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;The Crime and Policing Act 2026 (CPA), which received Royal Assent on April 29, 2026, comes into force on June 29, 2026, making it easier for enforcement authorities to prosecute companies for any criminal offense committed by senior managers acting within the scope of their authority.&lt;/p&gt;
&lt;p&gt;This new UK legislation significantly expands corporate criminal liability beyond specified economic crime offenses and requires businesses to review their compliance programs, including whistleblowing processes, to reduce the risk of liability.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;Historically, under the common law identification doctrine, criminal liability could only be attributed to a company where the &amp;ldquo;directing mind and will of the company&amp;rdquo; committed those actions. The courts interpreted this narrowly and, as a result, it was often challenging for law enforcement authorities to establish a link between the decision-maker and the criminal act, which was made more difficult as a result of increasingly large, modern companies with more complex management structures, where decisions are frequently decentralized.&lt;/p&gt;
&lt;p&gt;Under the Economic Crime and Corporate Transparency Act 2023 (ECCTA), corporate liability was introduced for the actions of a &amp;ldquo;senior manager,&amp;rdquo; who &amp;ldquo;plays a significant role in either the making of decisions about how the whole or a substantial part of the organization&amp;rsquo;s activities are to be managed or organized,&amp;rdquo; or &amp;ldquo;the actual managing or organizing of the whole or a substantial part of those activities.&amp;rdquo; However, this liability was limited to specified economic crimes.&lt;/p&gt;
&lt;h2&gt;What Will Change Under the CPA?&lt;/h2&gt;
&lt;p&gt;The reforms under the CPA further broaden the scope of offenses covered by ECCTA, making companies potentially liable for all crimes committed by their senior managers in the scope of their employment. Companies can now face prosecution for offenses relating to a broader array of criminal acts, including environmental law breaches, health and safety failings, discrimination, modern slavery, and data protection breaches.&lt;/p&gt;
&lt;p&gt;Unlike the failure to prevent fraud offense under ECCTA, the CPA does not provide for a defense where a company has reasonable compliance measures in place to prevent a senior manager from committing the relevant offense. However, companies will not be liable where the conduct took place outside the UK.&lt;/p&gt;
&lt;h2&gt;What Does This Mean for Businesses?&lt;/h2&gt;
&lt;p&gt;With the widening of the test for attribution of corporate liability, enforcement authorities can prosecute businesses across a broader range of offenses. This will likely lead to an increase in corporate prosecutions and may result in more deferred prosecution agreements for companies.&lt;/p&gt;
&lt;p&gt;In light of these amendments, it is crucial for businesses to clearly assess whether someone qualifies as a senior manager, as the determining factors are not limited to title or remuneration of the relevant individual. In the absence of official guidance, businesses must rely on their compliance framework. Businesses should review their senior management structure to identify the individuals who may fall within the definition of senior manager. The key risk is that individuals who trigger corporate liability may not themselves appreciate that they qualify as &amp;ldquo;senior managers.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;To mitigate increasing exposure, businesses should update their corporate governance framework, including policies and procedures at all levels, and conduct targeted training for senior and mid-tier management on key risk areas. While the defense of reasonable procedures is not automatically available, this will still be considered under mitigation and in the public interest, and so it will be vital for companies to have suitable policies and procedures in place, and for those to be operating well.&lt;/p&gt;
&lt;p&gt;* Sophia Kim contributed to this Advisory. Sophia is employed as a Trainee Solicitor in Arnold &amp;amp; Porter&amp;rsquo;s London office.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{29926032-C983-4623-9884-776442672AEF}</guid><link>https://www.biosliceblog.com/2026/05/uk-mhra-consults-on-a-new-regulatory-framework-for-rare-disease-therapies/</link><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><title>UK MHRA Consults on a New Regulatory Framework for Rare Disease Therapies</title><pubDate>Fri, 29 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{2D0FE30F-9197-4B43-A790-851F17CB6E21}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/05/virtual-digital-health-digest</link><a10:author><a10:name>Allison W. Shuren</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shuren-allison-w</a10:uri><a10:email>allison.shuren@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abeba Habtemariam</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/habtemariam-abeba</a10:uri><a10:email>Abeba.Habtemariam@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nancy L. Perkins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/perkins-nancy-l</a10:uri><a10:email>nancy.perkins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jacqueline L. Degann</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/degann-jacqueline</a10:uri><a10:email>jackie.degann@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Casey Brouhard</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brouhard-casey</a10:uri><a10:email>casey.brouhard@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brianna Morigney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/morigney-brianna</a10:uri><a10:email>brianna.morigney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sofia Holmquist</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/holmquist-sofia</a10:uri><a10:email>sofia.holmquist@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mickayla A. Stogsdill</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/stogsdill-mickayla</a10:uri><a10:email>mickayla.stogsdill@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katie Brown</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brown-katie</a10:uri><a10:email>katie.brown@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Caroline Oliver</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/oliver-caroline</a10:uri><a10:email>caroline.oliver@arnoldporter.com</a10:email></a10:author><title>Virtual &amp; Digital Health Digest</title><description>This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2026 from the United States, United Kingdom, and European Union.</description><pubDate>Fri, 29 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2026 from the United States, United Kingdom, and European Union.&lt;/p&gt;
&lt;h2&gt;In this issue, you will find the following:&lt;/h2&gt;
&lt;h3&gt;U.S. News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Health Care Fraud And Abuse Updates"&gt;Health Care Fraud and Abuse Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy and AI Updates"&gt;Privacy and Artificial Intelligence (AI) Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;U.S. Featured Content &lt;/h3&gt;
&lt;p&gt;This month&amp;rsquo;s edition includes updates on health care fraud and abuse enforcement, U.S. Food and Drug Administration (FDA) artificial intelligence (AI) modernization, AI-enabled medical device regulation, state privacy and AI developments, and federal policy activity. Key items include U.S. Health and Human Services Administration Office of Inspector General&amp;rsquo;s (HHS-OIG) April 2026 audit identifying $2.3 million in improper Medicare payments for virtual check-ins and e-visits from 2019 to 2022; the sentencing of Reyad Salahaldeen and Mohamad Mustafa for a genetic testing fraud and kickback scheme involving approximately $522 million in false claims; FDA&amp;rsquo;s launch of Elsa 4.0 and the HALO data platform to support AI-enabled regulatory review and workflow automation; International Medical Device Regulators Forum&amp;rsquo;s (IMDRF) draft framework for life cycle management of AI-enabled medical devices; Utah&amp;rsquo;s decision to continue its AI prescription-renewal pilot with physician oversight; Colorado&amp;rsquo;s proposed bill to replace its existing AI consumer protection law; and several federal AI policy developments, including the American Leadership in AI Act, a congressional investigation into Chinese-developed AI models, reintroduction of the CREATE AI Act, and MACPAC&amp;rsquo;s recommendation for greater state oversight of automation in Medicaid managed care coverage and authorization processes.&lt;/p&gt;
&lt;h3&gt;EU and UK News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;EU/UK Featured Content &lt;/h3&gt;
&lt;p&gt;Regulatory activity in the EU and UK over the past month has focused on AI in health care, health data access, and digital innovation frameworks. Recent regulatory developments in the EU and UK point to a decisive shift from high level policy ambition to the practical mechanics of enabling AI driven health care, with particular emphasis on health data governance, regulatory pilots, and institutional readiness.&lt;/p&gt;
&lt;p&gt;At the EU level, attention is increasingly focused on building durable frameworks to support innovation while maintaining regulatory confidence. The European Medicines Agency is preparing to pilot enhanced regulatory support for breakthrough medical devices and in vitro diagnostics (IVD), an initiative expected to shape future reforms of the EU medical device and IVD regimes. In parallel, the European Commission has taken further steps to operationalize the European Health Data Space (EHDS) through new implementing rules on the governance of the European Health Data Space Board, signaling a move from legislation to execution. The European Data Protection Board (EDPB) has also issued draft guidelines on the application of the General Data Protection Regulation (GDPR) to scientific research, offering long awaited clarification on lawful bases, consent models, and secondary use of data, issues that are central to data intensive research and AI development and likely to influence practice across Member States once finalized.&lt;/p&gt;
&lt;p&gt;In the UK, scrutiny has centered on whether existing data and regulatory structures are capable of supporting personalized medicine and AI at scale. Evidence to the House of Lords Science and Technology Committee highlighted the UK&amp;rsquo;s rich but underexploited health data assets and the persistence of access barriers since the pandemic, with witnesses pointing to fragmented governance and delays in data access as ongoing constraints. At the same time, the expansion of the Medicines and Healthcare products Regulatory Agency&amp;rsquo;s (MHRA) AI Airlock program, continued work by the National AI Commission, and targeted support for AI driven drug discovery reflect a more iterative, test and learn approach to AI regulation, focused on post market oversight rather than wholesale reform.&lt;/p&gt;
&lt;h2&gt;U.S. News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Health Care Fraud And Abuse Updates"&gt;Health Care Fraud And Abuse Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://oig.hhs.gov/documents/audit/11585/A-05-23-00001.pdf" target="_blank"&gt;HHS-OIG Audit on Improper Payments for Virtual Check-In and E-visit Services&lt;/a&gt;&lt;/strong&gt;. On April 23, 2026, HHS-OIG released an audit titled, &amp;ldquo;CMS Could Strengthen Medicare Program Safeguards To Prevent and Detect Potentially Improper Payments for Virtual Check-in and E-visit Services.&amp;rdquo; The purpose of the audit was to determine vulnerabilities associated with improper payments for virtual care services. OIG&amp;rsquo;s audit found that between 2019 and 2022, Centers for Medicare &amp;amp; Medicaid Services (CMS) paid $2.3 million in improper Medicare payments involving virtual check-ins and e-visits. As a result, OIG recommended that (1) CMS develop system edits for billing technology-based Medicare services; (2) CMS strengthen the Healthcare Common Procedure Coding System (HCPCS) code descriptions for virtual check-ins; and (3) CMS educate providers on billing requirements for virtual check-ins and e-visits. CMS concurred with the first and third recommendations. &lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/two-sentenced-prison-522m-genetic-testing-fraud-and-illegal-kickback-scheme-targeting" target="_blank"&gt;Two Georgia Men Sentenced for Role in Genetic Testing Fraud and Kickback Scheme&lt;/a&gt;&lt;/strong&gt;. On May 4, 2026, two Georgia men, Reyad Salahaldeen and Mohamad Mustafa, were sentenced for their roles in a Medicare, Medicaid, and private health insurance fraud scheme. Salahaldeen controlled four laboratories, two of which Salahaldeen controlled with Mustafa. From 2018 through August 2020, the two paid kickbacks and bribes to marketers who targeted Medicare and Medicaid beneficiaries and individuals covered by private insurance to obtain health information and DNA samples for genetic tests. The marketers obtained DNA samples via telemarketing and methods of in-person solicitation. Additionally, at the direction of Salahaldeen and Mustafa and in exchange for kickbacks, the marketers obtained fraudulent lab forms for tests from medical providers who did not treat or consult with the patients. Salahaldeen then falsified lab forms, letters for medical necessity, and other medical records. &lt;/p&gt;
&lt;p&gt;In total, the four laboratories controlled by the defendants submitted approximately $522 million in false claims, of which Medicare, Medicaid, and private insurers paid approximately $84 million.&lt;/p&gt;
&lt;h3&gt;&lt;a name="FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;FDA Announces Launch of Updated Elsa AI Platform&lt;/strong&gt;. On May 6, 2026, FDA &lt;a rel="noopener noreferrer" href="https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation?utm_medium=email&amp;amp;utm_source=govdelivery" target="_blank"&gt;announced&lt;/a&gt; significant advancements in its agency-wide AI modernization efforts, including the launch of &amp;ldquo;Elsa 4.0,&amp;rdquo; an upgraded internal AI platform now available to all FDA staff, and the consolidation of more than 40 applications and submission systems into a unified data platform called HALO (Harmonized AI &amp;amp; Lifecycle Operations for Data). By integrating Elsa with HALO, FDA aims to enable staff to query data, automate workflows, and access agency information more efficiently without manual document uploads. FDA leadership described the initiative as a major step toward embedding AI directly into regulatory operations to accelerate scientific review processes and support faster delivery of treatments to patients.&lt;/p&gt;
&lt;p&gt;The updated Elsa platform introduces expanded capabilities such as custom AI agents, document generation, quantitative data analysis and visualization, secure web search functionality, voice-to-text dictation, optical character recognition (OCR), and enhanced search tools for large document repositories. FDA emphasized that Elsa operates within a FedRAMP High Secure Google Cloud environment, does not train on industry-submitted data, and maintains human oversight throughout all AI-assisted processes. FDA characterized these developments as part of a broader strategy to streamline operations, reduce administrative burdens on reviewers and investigators, and advance regulatory science through responsible AI deployment.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;IMDRF Releases Technical Framework for AI Management&lt;/strong&gt;. On April 7, 2026, the IMDRF released a &lt;a rel="noopener noreferrer" href="https://www.imdrf.org/sites/default/files/2026-04/IMDRF%20AIML%20WG%20N93%20DRAFT%202026%20-%20Technical%20Framework%20for%20Artificial%20Intelligence%20Life%20Cycle%20Management.pdf" target="_blank"&gt;draft technical framework&lt;/a&gt; addressing life cycle management for AI-enabled medical devices (Draft Framework), with public comments open through June 10, 2026. The draft document outlines a globally harmonized approach for the design, development, validation, deployment, monitoring, and retirement of AI-enabled medical technologies, building on the IMDRF&amp;rsquo;s prior Good Machine Learning Practice principles. The Draft Framework addresses key issues, including quality management systems, risk management, cybersecurity, human oversight, data governance, clinical evaluation, and real-world performance monitoring, while emphasizing patient safety, transparency, and responsible innovation.&lt;/p&gt;
&lt;p&gt;The Draft Framework also highlights emerging regulatory considerations unique to AI-enabled and machine learning-based medical devices, including risks related to automation bias, data drift, explainability, cybersecurity vulnerabilities, and adaptive or generative AI models. Notably, the Draft Framework places significant emphasis on post-market monitoring, real-world performance evaluation, traceability, and transparency in labeling and user communications. While the document is not intended to establish binding regulatory requirements, it signals increasing international alignment around expectations for AI-enabled medtech products and may help shape future regulatory approaches across jurisdictions, including FDA oversight of AI-driven medical devices.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy and AI Updates"&gt;Privacy and AI Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;Utah&amp;rsquo;s Office of Artificial Intelligence Policy Rejects Medical Licensing Board&amp;rsquo;s Call to Suspend AI Prescription Renewal Pilot&lt;/strong&gt;. On April 20, 2026, the Utah Medical Licensing Board sent a &lt;a rel="noopener noreferrer" href="https://www.fsmb.org/siteassets/communications/doctronic-letter-from-medical-board.pdf" target="_blank"&gt;letter &lt;/a&gt;to Utah&amp;rsquo;s Office of Artificial Intelligence Policy (OAIP) requesting immediate suspension of the state&amp;rsquo;s AI prescription-renewal pilot program, which was launched in January pursuant to an agreement between the state and health technology startup Doctronic, LLC. Under the pilot program, Doctronic deploys AI to automate guideline-based prescription renewals. In its letter, the Board stated that it was not consulted before the pilot launched and that prescription renewals require individualized clinical reassessment. The OAIP and the Utah Department of Commerce&amp;rsquo;s Division of Professional Licensing promptly &lt;a rel="noopener noreferrer" href="https://commerce.utah.gov/wp-content/uploads/2026/04/Medical-Board-Doctronic-Response.pdf" target="_blank"&gt;declined&lt;/a&gt; the Board&amp;rsquo;s request, explaining that the OAIP was created by the Utah Legislature under &lt;a rel="noopener noreferrer" href="https://le.utah.gov/~2024/bills/static/SB0149.html" target="_blank"&gt;SB 149&lt;/a&gt; with a mandate to operate an AI regulatory mitigation program authorizing temporary waivers of regulatory requirements to test AI technologies in controlled environments, and that the Doctronic pilot was reviewed by medical professionals prior to launch. The agencies further noted that the pilot is currently in Phase One, during which a licensed physician reviews and approves every AI-generated prescription renewal before it is transmitted to a pharmacy, and that the OAIP retains authority to modify or cancel the pilot if safety benchmarks are not met. The agencies invited the Board to collaborate going forward by reviewing pilot data, providing feedback on future proposals, and connecting OAIP with subject matter experts.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Colorado Senate Bill Proposed to Replace the State&amp;rsquo;s AI Consumer Protection Law&lt;/strong&gt;. On May 7, 2026, several Colorado Senators introduced state &lt;a rel="noopener noreferrer" href="https://leg.colorado.gov/bill_files/116013/download" target="_blank"&gt;Senate Bill 26-189&lt;/a&gt;, which would repeal and replace the Colorado Consumer Protection for Artificial Intelligence Act, which was enacted in May 2024 and is currently scheduled to take effect on June 30, 2026. SB 26-189 is largely based on recommendations from a working group convened by Governor Jared Polis and, unlike the existing law, would not require companies to explain how their AI systems work, but would require developers and deployers to notify consumers when AI is used to make consequential decisions and to provide consumers with an opportunity to appeal and request human review. If enacted, the bill would take effect on January 1, 2027.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;Former Bipartisan Artificial Intelligence Task Force Co-Chairs Introduced the American Leadership in AI Act&lt;/strong&gt;. On April 27, 2026, former Bipartisan Artificial Intelligence Task Force Co-Chairs Ted Lieu (D-CA) and Jay Obernolte (R-CA) introduced the American Leadership in AI Act (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/8516?s=1&amp;amp;r=1" target="_blank"&gt;H.R. 8516&lt;/a&gt;, &lt;a rel="noopener noreferrer" href="https://lieu.house.gov/sites/evo-subsites/lieu.house.gov/files/evo-media-document/lieu_041_xml.pdf" target="_blank"&gt;text&lt;/a&gt;). According to their &lt;a rel="noopener noreferrer" href="https://lieu.house.gov/media-center/press-releases/reps-lieu-and-obernolte-introduce-bipartisan-bill-advance-american" target="_blank"&gt;press release&lt;/a&gt;, the bill includes over 20 bipartisan proposals from the House Bipartisan AI Taskforce &lt;a rel="noopener noreferrer" href="https://republicans-science.house.gov/_cache/files/a/a/aa2ee12f-8f0c-46a3-8ff8-8e4215d6a72b/6676530F7A30F243A24E254F6858233A.ai-task-force-report-final.pdf" target="_blank"&gt;report&lt;/a&gt; published last Congress, including proposals that would codify AI literacy efforts at the National Science Foundation (NSF), establish an AI education scholarship program at NSF, expand research on AI in education, and establish community college and area career and technical education centers of AI excellence. While bipartisan, the bill has no additional cosponsors and is unlikely to make significant progress this Congress. Additionally, we expect Rep. Obernolte to release a separate AI legislative package aligned with Congressional Republican and White House AI priorities.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;House Committee Chairs Announce a Joint Investigation Into the National Security and Cybersecurity Risks Posed by Chinese-Developed AI Models&lt;/strong&gt;. On April 29, 2026, House Select Committee on China Chairman John Moolenaar (R-MI) and House Committee on Homeland Security Chairman Andrew R. Garbarino (R-NY) &lt;a rel="noopener noreferrer" href="https://chinaselectcommittee.house.gov/media/press-releases/chairmen-moolenaar-garbarino-announce-joint-investigation-into-airbnb-anysphere-and-the-national-security-risks-posed-by-chinese-ai-models" target="_blank"&gt;announced&lt;/a&gt; a joint investigation into the national security and cybersecurity risks posed by Chinese-developed AI models, including DeepSeek, Alibaba, Moonshot AI, and MiniMax. The investigation reflects concerns that some China based AI companies may be using unauthorized techniques to derive capabilities from U.S. models and incorporate them into lower cost systems that are subsequently offered to American users, developers, or businesses.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Senators Reintroduce the Creating Resources for Every American to Experiment With Artificial Intelligence Act (CREATE AI Act)&lt;/strong&gt;. On April 29, 2026, Sens. Todd Young (R-IN), Martin Heinrich (D-NM), Mike Rounds (R-SD), and Cory Booker (D-NJ) &lt;a rel="noopener noreferrer" href="https://www.young.senate.gov/newsroom/press-releases/young-colleagues-introduce-bill-to-advance-ai-innovation-reliability-for-americans/" target="_blank"&gt;reintroduced&lt;/a&gt; the CREATE AI Act (&lt;a rel="noopener noreferrer" href="https://www.young.senate.gov/wp-content/uploads/ROM261451.pdf" target="_blank"&gt;S. 4441&lt;/a&gt;). The bill would establish the National Artificial Intelligence Research Resource (NAIRR), a shared national research infrastructure to connect individuals to tools to advance AI research and development (R&amp;amp;D).&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Medicaid and CHIP Payment and Access Commission (MACPAC) Holds &lt;a rel="noopener noreferrer" href="https://www.macpac.gov/meeting/may-2026-public-meeting/" target="_blank"&gt;May 2026 Public Meetings&lt;/a&gt;&lt;/strong&gt;. On May 7, 2026, MACPAC held its &lt;a rel="noopener noreferrer" href="https://www.macpac.gov/meeting/may-2026-public-meeting/" target="_blank"&gt;May 2026 Public Meeting&lt;/a&gt; featuring a panel titled, &amp;ldquo;Automation in Medicaid Prior Authorization: Recommendations.&amp;rdquo; During the session, MACPAC Commissioner Michael Nardone suggested further review is needed to discuss the benefits of AI and the need for federal regulations of Medicaid decision-making that are flexible for AI. He noted that AI is evolving faster than state and federal regulations can be developed and implemented.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;The commission voted affirmatively on the following recommendation: State Medicaid agencies should amend their Medicaid managed care plan contracts to require disclosure or other reporting of the use of automation in plans&amp;rsquo; coverage and authorization processes. Disclosure should facilitate state visibility into the applications of automation tools and other elements of automation. States should also modify existing reporting requirements and oversight processes to minimize administrative burden.&amp;nbsp;&lt;/p&gt;
&lt;h2&gt;EU and UK News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ec.europa.eu/newsroom/sante/newsletter-archives/74172" target="_blank"&gt;European Medicines Agency (EMA) Will Launch Pilot to Support Breakthrough Medical Devices and IVDs&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The pilot is expected to be launched in the second quarter of 2026 to support breakthrough medical devices and IVDs, with the objective of testing a pathway that accelerates patient access to highly innovative technologies while maintaining the EU&amp;rsquo;s high standards for safety and performance. Under the pilot, manufacturers of devices granted designated breakthrough will benefit from enhanced regulatory support, including priority scientific advice from EMA- administered medical device expert panels. The initiative builds on the &lt;a rel="noopener noreferrer" href="https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf" target="_blank"&gt;MDCG 2025-9 Guidance on Breakthrough Devices&lt;/a&gt; adopted by the Medical Device Coordination Group (MDCG) in December 2025. Importantly, the pilot is intended to inform and shape a future EU breakthrough devices framework proposed by the European Commission in its December 2025 legislative revisions to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including the introduction of new Article 52a of the MDR and new Article 48a of the IVDR. As such, the pilot represents a key step in strengthening an innovation friendly regulatory environment for medical technologies within the EU.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.imdrf.org/consultations/technical-framework-artificial-intelligence-life-cycle-management" target="_blank"&gt;IMDRF Opens Public Consultation on a Draft Technical Framework for AI Lifecycle Management&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;.The framework builds on the IMDRF&amp;rsquo;s previously published Good Machine Learning Practice guiding principles and sets out an internationally harmonized set of considerations and concepts spanning the entire life cycle of AI-enabled medical devices, from design and development through deployment, performance monitoring, and change management. The framework is intended primarily for manufacturers of AI-enabled medical devices, including those incorporating machine learning, and recognizes that devices using generative, autonomous, or adaptive AI technologies may require additional or heightened considerations. It aims to promote harmonized concepts and regulatory considerations across jurisdictions by describing common terminology, risk based concepts, and life cycle practices that authorities may align with their own regulatory frameworks. The document is non-binding and is not intended to serve as regulation or jurisdiction-specific guidance. The IMDRF invites stakeholder feedback on the draft until July 10, 2026. &lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/mhra-expands-ai-airlock-programme-with-a-36-million-funding-boost-over-three-years?utm_medium=email&amp;amp;utm_campaign=govuk-notifications-topic&amp;amp;utm_source=5edf5538-ec86-4e51-8e09-d301ffa741e0&amp;amp;utm_content=daily" target="_blank"&gt;MHRA Announces Expansion of Its AI Airlock Program, Along With Major Additional Funding&lt;/a&gt;&lt;/strong&gt;. The MHRA has secured a &amp;pound;3.6 million multi-year funding uplift to expand its AI Airlock program, the UK&amp;rsquo;s first regulatory sandbox for artificial intelligence as a medical device (AIaMD). As reported in the &lt;a href="/en/perspectives/publications/2025/12/virtual-and-digital-health-digest"&gt;November 2025 Digest&lt;/a&gt;, Phase two of the program explored the challenges of regulating AI-powered diagnostics. Following the conclusion of the second phase, the Department of Health and Social Care has committed &amp;pound;1.2 million per year over the next three years (2026 to 2029). The MHRA anticipates that it will be able to support more ambitious and longer-term testing models. Reporting is expected in summer 2026, along with the findings from the pilot phase, informing the design of phase three.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://medregs.blog.gov.uk/2026/04/17/shaping-the-future-of-healthcare/" target="_blank"&gt;UK National AI Commission Publishes Blog on the Future of AI in Health Care&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. Professor Henrietta Hughes, the Patient Safety Commissioner, has authored a blog post on the work of the National AI Commission into the regulation of AI in health care. She provides insight into the responses received to the call for evidence, aimed at helping to inform the commission with its recommendations. The post refers to concerns raised in responses to the &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/calls-for-evidence/regulation-of-ai-in-healthcare" target="_blank"&gt;call for evidence&lt;/a&gt;, including the post-market monitoring of AIaMD, uncertainty around liability when AI is involved in clinical decision-making, and the need for strong safeguards alongside innovation. Broader engagement work, including MHRA-led sector roundtables involving over 30 organizations and 117 clinicians, showed that the public is more comfortable with AI supporting clinicians than making high-stakes decisions independently. The commission&amp;rsquo;s recommendations are on track to be published in Summer 2026.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/ai-firms-pioneering-drug-discovery-cheaper-supercomputing-and-more-get-first-backing-through-uks-sovereign-ai" target="_blank"&gt;UK&amp;rsquo;s Government-Backed Sovereign AI Unit Announces Support for Companies Pioneering AI in Drug Discovery&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. Sovereign AI is the UK&amp;rsquo;s &amp;pound;500 million national initiative to support promising AI companies to start, scale, and compete globally from the UK. Designed to operate like a venture capital fund with the backing of the state, the Unit combines direct investment with a comprehensive support package, including fully funded access to the UK&amp;rsquo;s largest AI supercomputers and hands-on government support navigating data access, procurement, product validation, and routes into new regulatory approaches. The first companies to receive support include a company using AI to tackle brain diseases such as Alzheimer&amp;rsquo;s and Parkinson&amp;rsquo;s, and a company developing a foundation model for AI-driven strain design in engineering biology and biomanufacturing. In addition, several startups are receiving access to the AI Research Resource supercomputer network, enabling them to train advanced models and scale cutting edge AI technologies on sovereign UK infrastructure.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/mhra-hires-top-global-tech-talent-to-transform-systems-behind-regulation-of-medicines-and-medical-devices?utm_medium=email&amp;amp;utm_campaign=govuk-notifications-topic&amp;amp;utm_source=7cb7049c-4a6b-4c93-8afa-890e23b74f49&amp;amp;utm_content=daily" target="_blank"&gt;UK MHRA Strengthens Its Digital Health and Technology Expertise With New Appointment From the U.S. Centers for Disease Control and Prevention&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. It has been announced that Jason Bonander will join the MHRA as Chief Digital and Technology Officer from late May 2026, bringing extensive experience from his role as Chief Information Officer at the U.S. Centers for Disease Control and Prevention. In his new role at the MHRA, he will work to modernize the MHRA&amp;rsquo;s services and platforms to support efficiency, transparency, and faster regulation.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://committees.parliament.uk/event/27021" target="_blank"&gt;House of Lords Science and Technology Committee Holds Further Oral Evidence Sessions on Personalized Medicine and AI as Part of Its Inquiry Into NHS Innovation&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. On April 14, 2026, evidence was heard from Professor Andrew Morris (Director of Health Data Research UK) and Professor Cathie Sudlow (Director of the Usher Institute, University of Edinburgh, and author of the 2024 &amp;ldquo;Uniting the UK&amp;rsquo;s Health Data&amp;rdquo; review). Both witnesses highlighted that the UK possesses uniquely rich health data assets but continues to under-utilize their value due to fragmented access arrangements and persistent barriers to the linkage of individual level datasets, which they described as essential to enabling large scale research, innovation, and the effective deployment of AI. The work during the pandemic was praised as a proof-of-concept for how data can be leveraged at scale. However, it was noted that since then, access barriers to health data for bona fide research purposes have become more difficult, with delays, inconsistent decision making, and uncertainty in approval routes deterring researchers and innovators. The newly established Health Data Research Service (HDRS) was broadly welcomed as a potential national coordinating body for data access and governance. Key recommendations included treating health data as critical national infrastructure, streamlining the legal framework for data access, closing the primary care data gap, embedding continuous public engagement, and fostering public trust through transparency.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.edpb.europa.eu/system/files/2026-04/edpb_guidelines_202601_scientificresearch_en.pdf" target="_blank"&gt;European Data Protection Board Adopts Guidelines 1/2026 on Processing of Personal Data for Scientific Research Purposes&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The guidelines provide clarification on how the General Data Protection Regulation (EU) 2016/679 (GDPR) applies for scientific research purposes. In particular, the guidelines clarify the scope of &amp;ldquo;scientific research&amp;rdquo; under the GDPR and introduce six indicative factors (e.g., adherence to ethical standards, societal objectives), which, if met, create a presumption that an activity constitutes scientific research under the GDPR. The guidelines also provide guidance on the legal bases for data processing, and confirm that data controllers may rely on broad consent and dynamic consent, or a combination of both, under certain conditions. In addition, the guidelines confirm that further processing of the data for scientific research purposes is presumed compatible with the original purpose of collection under Article 5(1)(b) GDPR, and that personal data may be stored for longer periods of time for scientific research purposes, even if the original purposes for processing the data have been fulfilled. The EDPB has opened a public consultation on the guidelines, which closes on June 25, 2026.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771" target="_blank"&gt;European Commission Adopts Implementing Regulation (EU) 2026/771 on the EHDS&lt;/a&gt;&lt;/strong&gt;. The Implementing Regulation sets out the rules for the implementation of the EHDS Regulation (EU) 2025/327 (see our &lt;a href="/en/perspectives/advisories/2025/03/european-health-data-space-regulation-published"&gt;March 2025 Advisory&lt;/a&gt;) in regard to the establishment, management, and functioning of the EHDS Board. The EHDS Board, which will be composed of representatives from EU Member States and the European Commission, will serve as a forum for cooperation and exchange of information among EU Member States. Some responsibilities of the EHDS Board include supporting the consistent implementation of the EHDS Regulation across EU Member States, and issuing guidance and opinions to national competent authorities and other stakeholders involved in the implementation of the EHDS Regulation.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2026/04/final-storage-and-access-technologies-guidance-published/" target="_blank"&gt;UK Information Commissioner&amp;rsquo;s Office (ICO) Finalizes Guidance on Storage and Access Technologies (SATs)&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. This guidance covers how the Privacy and Electronic Communications Regulations (PECR) and the UK GDPR apply to cookies, tracking pixels, and device fingerprinting, reflecting changes introduced by the &lt;a href="/en/perspectives/advisories/2025/07/the-data-use-and-access-act-2025-explained"&gt;Data (Use and Access) Act 2025&lt;/a&gt;. It is intended to provide clarification on the law as it currently stands and is separate from the ICO&amp;rsquo;s ongoing work to review Regulation 6 of PECR for online advertising purposes. This guidance is relevant to life sciences companies operating patient-facing digital platforms, apps, and wearable device interfaces that use tracking technologies.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&lt;em&gt;Kuran Phull&amp;nbsp;is employed as a trainee solicitor at Arnold &amp;amp; Porter&amp;rsquo;s London office. Amalia is not admitted to the practice of law.&lt;br /&gt;
&lt;/em&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C3860B48-6A5B-45DF-9948-6FFB11E7DFD7}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/the-new-yorker-quotes-ambassador-barbara-leaf-on-operation-epic-fury-in-iran</link><title>The New Yorker Quotes Ambassador Barbara Leaf on Operation Epic Fury in Iran</title><description>Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf (Amb. Leaf) was quoted in &lt;em&gt;The New Yorker&lt;/em&gt; article, &amp;ldquo;The Epic Disaster of Operation Epic Fury,&amp;rdquo; on the strategic and diplomatic consequences of the Trump administration&amp;rsquo;s war with Iran.</description><pubDate>Thu, 28 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf (Amb. Leaf) was quoted in &lt;em&gt;The New Yorker&lt;/em&gt; article, &amp;ldquo;The Epic Disaster of Operation Epic Fury,&amp;rdquo; on the strategic and diplomatic consequences of the Trump administration&amp;rsquo;s war with Iran.&lt;/p&gt;
&lt;p&gt;Amb. Leaf noted that the proposed ceasefire framework reportedly fails to address several of the administration&amp;rsquo;s original justifications for military action, including Iran&amp;rsquo;s ballistic missile and drone capabilities and Tehran&amp;rsquo;s support for regional proxy groups such as Hezbollah. She also observed that Iran continued rebuilding missile-production infrastructure during the ceasefire and retained a significant portion of its prewar missile stockpile.&lt;/p&gt;
&lt;p&gt;In discussing the political aftermath of the conflict, Amb. Leaf explained that the war appears to have strengthened the influence of the Islamic Revolutionary Guard Corps (IRGC) within the Iranian government, resulting in a more hard-line and &amp;ldquo;more cohesive&amp;rdquo; regime. She further noted that the Trump administration underestimated &amp;ldquo;the regime&amp;rsquo;s resilience,&amp;rdquo; despite extensive military strikes and leadership losses.&lt;/p&gt;
&lt;p&gt;Amb. Leaf commented that Trump&amp;rsquo;s efforts to expand the U.S. goals of the war by mandating Middle East leaders to normalize relations with Israel were met with &amp;ldquo;a stunned silence&amp;hellip;There are no takers.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.newyorker.com/news/the-lede/the-epic-disaster-of-operation-epic-fury" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{33DBD019-EBA3-4D11-BA10-642D8A287E79}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/new-york-takes-aim-at-self-gras</link><a10:author><a10:name>Raqiyyah Pippins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pippins-raqiyyah</a10:uri><a10:email>raqiyyah.pippins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brandon W. Neuschafer</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/neuschafer-brandon-w</a10:uri><a10:email>brandon.neuschafer@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ada Ohanenye</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/ohanenye-ada</a10:uri><a10:email>ada.ohanenye@arnoldporter.com</a10:email></a10:author><title>New York Takes Aim at Self-GRAS: Mandatory Disclosure Law Poised to Reshape Food Ingredient Oversight</title><description>On April 21, 2026, the New York Assembly passed the Food Safety and Chemical Disclosure Act, legislation that would establish the first state-level public disclosure regime for substances deemed &amp;ldquo;generally recognized as safe&amp;rdquo; (GRAS). If enacted, the law would require companies to submit detailed scientific support for GRAS determinations before such substances could be sold or used in food in New York, signaling a significant shift toward increased transparency and regulatory scrutiny of food ingredient safety.</description><pubDate>Thu, 28 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On April 21, 2026, the New York Assembly passed the &lt;a rel="noopener noreferrer" href="https://legislation.nysenate.gov/pdf/bills/2025/s1239f" target="_blank"&gt;Food Safety and Chemical Disclosure Act&lt;/a&gt; legislation that would establish a first-of-its-kind reporting regime for substances deemed &amp;ldquo;generally recognized as safe&amp;rdquo; (GRAS). While state laws have long prohibited the sale of adulterated or misbranded food, they have not required companies to submit GRAS determinations or otherwise disclose the basis for those conclusions at the state level. Although the bill still awaits action by the New York Governor, its passage by the Senate and Assembly signals a potential inflection point in food regulation and a broader shift toward increased transparency in food ingredient safety.&lt;/p&gt;
&lt;p&gt;Specifically, the legislation would expand New York&amp;rsquo;s current regulatory framework by making it unlawful to sell or use a GRAS substance in food in the state unless a detailed report has been submitted to the New York Department of Agriculture and made publicly available. The required report would include extensive information regarding the ingredient, including its identity and method of manufacture, intended conditions of use, dietary exposure estimates, and a comprehensive safety narrative supporting the GRAS conclusion, as well as a discussion of any contrary or inconsistent data and supporting documentation. The legislation would take effect approximately 180 days after enactment, with phased implementation for certain provisions. Specifically, the GRAS reporting requirements are tied to the development and implementation of a public, state-maintained database and associated rulemaking. If enacted, New York would be the first state to require manufacturers to publicly disclose the scientific basis underlying GRAS determinations, rather than relying on the longstanding self-affirmation framework.&lt;/p&gt;
&lt;p&gt;Currently, no state independently regulates GRAS determinations. Instead, GRAS is governed by the federal framework established under the Federal Food, Drug, and Cosmetic Act. Under that framework, companies may self-determine that a substance is GRAS without notifying the U.S. Food and Drug Administration (FDA) or publicly disclosing the underlying data. FDA also administers a voluntary GRAS notification program, under which companies may submit a GRAS notice for review, though participation in that program is not required. While companies self-determine their GRAS status, FDA does still &lt;a rel="noopener noreferrer" href="https://www.fda.gov/media/109006/download" target="_blank"&gt;issue guidance&lt;/a&gt; describing best practices for supporting GRAS conclusions, including recommendations regarding the scientific data and information that should be evaluated and the qualifications and independence of experts involved in the review process.&lt;/p&gt;
&lt;p&gt;Alongside New York&amp;rsquo;s proposed legislation, activity at both the federal and state levels suggests increasing scrutiny of the GRAS framework, although no effort to date has matched the scope of New York&amp;rsquo;s proposal. At the federal level, FDA has indicated that it is considering reforms to the GRAS program. In 2026, FDA announced plans to pursue rulemaking that would significantly revise the current framework. The &lt;a rel="noopener noreferrer" href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;amp;RIN=0910-AJ02" target="_blank"&gt;proposed rule&lt;/a&gt; would amend the GRAS regulations in 21 C.F.R. Parts 170 and 570 to require the mandatory submission of GRAS notices for substances intended for use in human and animal food. It would also clarify that FDA will maintain and update a public-facing inventory of GRAS notices for substances subject to the requirement. To date, however, these efforts remain under consideration and have not been implemented.&lt;/p&gt;
&lt;p&gt;At the state level, most activity has focused on banning or restricting specific food additives rather than regulating the GRAS determination process itself. A smaller number of states have begun to explore more direct oversight of GRAS. For example, &lt;a rel="noopener noreferrer" href="https://pub.njleg.state.nj.us/Bills/2026/S3500/3277_I1.PDF" target="_blank"&gt;proposed legislation&lt;/a&gt; in New Jersey would require limited reporting of certain GRAS determinations to state regulators, while &lt;a rel="noopener noreferrer" href="https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202520260AB2034" target="_blank"&gt;proposals&lt;/a&gt; in California would restrict reliance on self-affirmed GRAS determinations that have not been submitted to FDA. These efforts, however, remain more limited in scope. New York&amp;rsquo;s bill would go further by establishing a comprehensive reporting and public disclosure regime, representing the most direct state-level intervention into the GRAS process to date.&lt;/p&gt;
&lt;p&gt;New York&amp;rsquo;s proposed legislation raises significant considerations for entities across the food industry. It signals a shift toward transparency that has not historically been required in the development and use of food ingredients. Companies should be prepared to adapt to a regime in which GRAS determinations, and the data supporting them, may be subject to public disclosure and regulatory scrutiny. In anticipation of potential enactment, entities may wish to consider the following:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Ingredient Manufacturers&lt;/strong&gt;: Ingredient manufacturers should ensure that GRAS determinations are supported by robust, well-documented analyses, particularly for novel ingredients. Companies should also evaluate whether existing documentation is suitable for public disclosure, given that supporting data may be accessible to regulators, competitors, and consumers.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Food Manufacturers&lt;/strong&gt;: Food manufacturers should enhance supply chain diligence and confirm that GRAS substances used in their products are supported by appropriate documentation from suppliers. Companies should also assess whether ingredients are likely to be reported or exempt under the proposed framework and consider potential reformulation strategies for products sold in New York.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Distributors and Retailers&lt;/strong&gt;: Entities further downstream in the supply chain should be aware that the legislation applies broadly to the sale of food products in New York and may require additional assurances from suppliers regarding the compliance status of ingredients used in products offered for sale.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;We recommend that companies continue to closely monitor developments related to the New York legislation, as well as evolving federal and state activity in this area. Companies should also consider evaluating their current GRAS inventories, supporting documentation, and regulatory strategies in anticipation of potential changes. As scrutiny of food ingredient safety continues to increase, proactive planning may help mitigate compliance risks and position companies to respond effectively to a shifting regulatory landscape.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{470D6AF4-0F58-4BF2-8E8C-8CF87F0C5179}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/eu-withdrawal-button-uk-subscription-rules-and-data-protection-risks-for-us-online-sellers</link><author>james.castro-edwards@arnoldporter.com</author><title>EU Withdrawal Button, UK Subscription Rules, and Data Protection Risks for U.S. Online Sellers</title><description>Regulators are intensifying scrutiny of subscription practices worldwide, as we previously highlighted in our discussion of U.S. developments, and the European Union (EU) and United Kingdom (UK) are now moving aggressively ahead of the United States. In the EU, Directive 2023/2673 comes into force on June 19, 2026, requiring all businesses that sell online to EU consumers to provide a mandatory digital withdrawal function for consumer (B2C) contracts. In the UK, the Digital Markets, Competition and Consumers Act 2024 (DMCCA) will introduce new rules for subscription contracts effective Spring 2027. Together, these represent the most significant overhaul of online consumer law in over a decade. Both also carry data protection implications that may not be immediately obvious.</description><pubDate>Thu, 28 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Introduction&lt;/h2&gt;
&lt;p&gt;Regulators are intensifying scrutiny of subscription practices worldwide, as we previously highlighted in &lt;a href="/en/perspectives/advisories/2026/02/ftc-and-state-ags-continue-to-scrutinize-subscription-practices"&gt;our discussion of U.S. developments&lt;/a&gt;, and the European Union (EU) and United Kingdom (UK) are now moving aggressively ahead of the United States. In the EU, Directive 2023/2673 comes into force on June 19, 2026, requiring all businesses that sell online to EU consumers to provide a mandatory digital withdrawal function for consumer (B2C) contracts. In the UK, the Digital Markets, Competition and Consumers Act 2024 (DMCCA) will introduce new rules for subscription contracts effective Spring 2027. Together, these represent the most significant overhaul of online consumer law in over a decade. Both also carry data protection implications that may not be immediately obvious.&lt;/p&gt;
&lt;h2&gt;1. The EU Withdrawal Button (Effective June 19, 2026)&lt;/h2&gt;
&lt;h3&gt;Who Does This Apply to and What Is Required?&lt;/h3&gt;
&lt;p&gt;Directive 2023/2673 amends the Consumer Rights Directive (2011/83/EU) (CRD) by introducing a new Article 11a. Its central principle is that withdrawing from a contract must be no more burdensome than concluding one. The obligation applies to any B2C distance contract concluded via an online interface (i.e., website, mobile app, or other software-based purchasing environment) where a statutory right of withdrawal exists. It applies regardless of where the seller is based, meaning that U.S. and UK retailers that target EU consumers are in scope. Contracts for which no right of withdrawal arises (bespoke goods, perishable items, sealed hygiene products, and certain digital downloads) fall outside of the new requirements.&lt;/p&gt;
&lt;p&gt;The withdrawal function must be clearly labeled with wording such as &amp;ldquo;withdraw from the contract here&amp;rdquo; or a close equivalent, and must remain accessible throughout the consumer&amp;rsquo;s 14-day withdrawal period. It must link to a structured two-step confirmation process, and must trigger an automatic confirmation email to the consumer without undue delay. Accordingly, a PDF form in the terms and conditions, or an instruction to email a returns address, will not comply.&lt;/p&gt;
&lt;h3&gt;Enforcement&lt;/h3&gt;
&lt;p&gt;Non-compliance exposes businesses to enforcement action in each EU member state. Competitors and consumer protection associations can also bring cease-and-desist proceedings. Member states were required to transpose the directive by December 19, 2025.&lt;/p&gt;
&lt;h3&gt;The Data Protection Dimension&lt;/h3&gt;
&lt;p&gt;The withdrawal button is not merely a user experience feature; it is a data processing operation. Linking a withdrawal to a specific consumer and contract requires the processing of personal data (name, contact details, or order reference), which must have a lawful basis under the European General Data Protection Regulation (GDPR). Article 6(1)(b) (performance of a contract) will generally apply, but the processing must be documented in Article 30 record of processing activity (ROPA) and privacy notices updated accordingly. The data minimization principle under Article 5(1)(c) applies: only data genuinely necessary to identify the consumer and the relevant contract should be collected. &lt;/p&gt;
&lt;h2&gt;2. The DMCCA Subscription Regime (Spring 2027)&lt;/h2&gt;
&lt;h3&gt;Background&lt;/h3&gt;
&lt;p&gt;The DMCCA&amp;rsquo;s consumer protection provisions came into force in April 2025, introducing rules on drip pricing and fake reviews and giving the UK Competition and Markets Authority (CMA) direct enforcement powers, including fines of up to 10% of global annual turnover. The subscription contracts regime, the most operationally complex element, has been delayed repeatedly. The government&amp;rsquo;s April 2026 consultation response confirmed a spring 2027 commencement, with further guidance to follow. The regime applies to consumer contracts that auto-renew indefinitely, that auto-renew after a free or discounted trial, or that are for a fixed term with auto-renewal. Financial services, utilities, and certain regulated healthcare contracts are excluded, as are certain charitable and cultural membership organizations. Non-UK businesses targeting UK consumers are in scope.&lt;/p&gt;
&lt;h3&gt;Key Obligations&lt;/h3&gt;
&lt;p&gt;Four categories of obligation apply, which are as follows:&lt;/p&gt;
&lt;ol&gt;
    &lt;li&gt;A new standalone pre-contract disclosure within the purchase journey, setting out subscription-specific key terms: price during any trial and thereafter, auto-renewal date, and how to cancel.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Two 14-day cooling-off periods: one immediately on entering the contract, and one after a free or discounted trial ends or a longer-term (12+ month) contract auto-renews.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Renewal reminders containing prescribed information, including the renewal date, amount due, and a warning that the consumer will incur liability unless they cancel.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;A cancellation obligation: cancellation must be straightforward and must not involve unnecessary steps. The &amp;ldquo;subscription trap&amp;rdquo; is precisely what the DMCCA is designed to end.&lt;/li&gt;
&lt;/ol&gt;
&lt;h3&gt;Data Protection&lt;/h3&gt;
&lt;p&gt;Renewal reminders, cooling-off records, and cancellation confirmations all involve the processing of personal data under the UK GDPR. The same analysis applies as for the EU withdrawal button: lawful basis, data minimization, accurate record-keeping, and appropriate retention schedules. Data protection should be built into the compliance program from the outset, not bolted on at the end of a technology project.&lt;/p&gt;
&lt;h3&gt;What Should Businesses Do Now?&lt;/h3&gt;
&lt;ol&gt;
    &lt;li&gt;&lt;strong&gt;EU withdrawal button (urgent)&lt;/strong&gt;: Implement the withdrawal function on all online interfaces used for EU B2C sales. Update withdrawal policies, terms and conditions, and privacy notices.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;DMCCA subscriptions (plan now)&lt;/strong&gt;: Audit subscription products against the new regime. Map pre-contract disclosures, renewal reminder processes and cancellation journeys, and begin technology development. Spring 2027 is closer than it appears for businesses with complex digital infrastructure.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;CMA compliance&lt;/strong&gt;: The CMA&amp;rsquo;s direct enforcement powers are already live. Review consumer-facing practices for compliance with the drip pricing and fake reviews rules now in force.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Data protection&lt;/strong&gt;: Update GDPR and UK GDPR documentation (records of processing, privacy notices, and retention schedules) to reflect new processing activities under both regimes.&lt;/li&gt;
&lt;/ol&gt;
&lt;h3&gt;Conclusion&lt;/h3&gt;
&lt;p&gt;The EU withdrawal button deadline is imminent. The DMCCA subscription regime is not far behind. Both carry real regulatory, financial, and reputational risk for non-compliant businesses, and both require data protection to be treated as an integral part of implementation rather than an afterthought. Businesses that act now, integrating legal, technology, and data protection workstreams, will be significantly better placed than those that do not.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7925EB39-235A-4820-9729-BB04211B9814}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/travis-annatoyn-speaks-with-law360-on-nepa-reviews-on-anniversary-of-seven-county-decision</link><title>Travis Annatoyn Speaks with Law360 on NEPA Reviews on Anniversary of Seven County Decision</title><description>Travis Annatoyn, Arnold &amp;amp; Porter counsel and former Deputy Solicitor for Energy and Mineral Resources at the U.S. Department of the Interior, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article &amp;ldquo;Seven County&amp;rsquo;s Legacy Still Unwritten A Year Later,&amp;rdquo; which examines how the U.S. Supreme Court&amp;rsquo;s decision in &lt;em&gt;Seven County Infrastructure Coalition v. Eagle County&lt;/em&gt; continues to affect federal environmental review and permitting practices under the National Environmental Policy Act (NEPA).</description><pubDate>Wed, 27 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Travis Annatoyn, Arnold &amp;amp; Porter counsel and former Deputy Solicitor for Energy and Mineral Resources at the U.S. Department of the Interior, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article &amp;ldquo;Seven County&amp;rsquo;s Legacy Still Unwritten A Year Later,&amp;rdquo; which examines how the U.S. Supreme Court&amp;rsquo;s decision in &lt;em&gt;Seven County Infrastructure Coalition v. Eagle County&lt;/em&gt; continues to affect federal environmental review and permitting practices under the National Environmental Policy Act (NEPA).&lt;/p&gt;
&lt;p&gt;Travis discussed how the decision has increased confidence among agencies and project developers defending NEPA reviews against litigation challenges. He explained that while parties still strive to prepare &amp;ldquo;perfect and spotless&amp;rdquo; environmental review documents, &lt;em&gt;Seven County&lt;/em&gt; has reduced concern that minor omissions or technical deficiencies will undermine otherwise robust agency analyses. Travis noted that the decision reinforces a more deferential judicial approach to agency decision-making and supports the idea that courts need not vacate project approvals over immaterial errors.&lt;/p&gt;
&lt;p&gt;He also cautioned that &lt;em&gt;Seven County&lt;/em&gt; does not insulate agencies from challenges based on substantive errors. He observed that aggressive permitting timelines and staffing constraints could increase the risk of agencies making significant analytical mistakes that remain vulnerable to judicial scrutiny. Accordingly, courts are still likely to intervene where agency decisions rely on flawed data or unreasonable analysis.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2479762/seven-county-s-legacy-still-unwritten-a-year-later" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{CE9071DB-66F7-42CC-A65E-77ADC1403898}</guid><link>https://www.biosliceblog.com/2026/05/virtual-and-digital-health-digest-april-2026/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emma Elliston, Ph.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/elliston-emma</a10:uri><a10:email>emma.elliston@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><title>Virtual and Digital Health Digest – April 2026</title><pubDate>Tue, 26 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{A07AA6D9-FAA6-423D-A1B1-8CEF85FCB0DB}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/iccs-2026-arbitration-rules-an-early-preview-of-the-changes-pt-1</link><a10:author><a10:name>Maria Chedid</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chedid-maria</a10:uri><a10:email>maria.chedid@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter L. Schmidt</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schmidt-peter</a10:uri><a10:email>peter.schmidt@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brooke F. D'Amore Bradley</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/damore-bradley-brooke</a10:uri><a10:email>brooke.damorebradley@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Lindsey II</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lindsey-anthony</a10:uri><a10:email>anthony.lindsey@arnoldporter.com</a10:email></a10:author><title>The ICC’s 2026 Arbitration Rules: An Early Preview of the Changes (Part 1)</title><description>The International Chamber of Commerce's (ICC) revised 2026 Arbitration Rules, effective June 1, 2026, introduce significant changes aimed at improving transparency, efficiency, and procedural flexibility in ICC arbitrations. Key updates include enhanced arbitrator disclosure obligations, the elimination of mandatory Terms of Reference in most cases, expanded expedited procedures for disputes up to $4 million, and broader emergency arbitration powers that allow urgent relief against a wider range of parties. Collectively, these reforms are expected to streamline proceedings, increase early conflict identification, and provide parties with more flexible and efficient dispute resolution mechanisms.</description><pubDate>Tue, 26 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;The International Court of Arbitration of the International Chamber of Commerce (ICC) has announced that its revised 2026 ICC Arbitration Rules (the Rules) will enter into force on June 1, 2026. Per the ICC, the amendments are aimed at enhancing transparency and efficiency in ICC proceedings, strengthening confidence in the arbitral process, and codifying several practices that have already developed under existing ICC case administration.&lt;/p&gt;
&lt;p&gt;In advance of the formal release of the revised Rules, the ICC is publishing a series of preview articles highlighting key forthcoming amendments and additions. This article summarizes the first set of early insights from the ICC and highlights the practical implications the changes may have for parties, counsel, and arbitrators involved in ICC arbitrations.&lt;/p&gt;
&lt;h2&gt;Part 1: Arbitrator Disclosure&lt;/h2&gt;
&lt;p&gt;A fundamental principle of arbitration is the independence and impartiality of the neutral, and the current ICC Rules include enhanced provisions related to an arbitrator&amp;rsquo;s obligations concerning disclosure of potential conflicts. The revised Rules elevate this requirement and codify two of the ICC Court of Arbitration&amp;rsquo;s long-standing expectations and practice: (1) that arbitrators should err on the side of transparency when considering potential disclosures, and (2) the mere fact of a disclosure should not call an arbitrator&amp;rsquo;s independence or impartiality into question. &lt;/p&gt;
&lt;p&gt;Specifically, the revised Rules will state: &amp;ldquo;doubts the prospective arbitrator may have about whether to make a disclosure shall be resolved in favour of disclosure&amp;rdquo; (Article 12(2)) and &amp;ldquo;disclosure does not, by itself, establish a lack of independence or impartiality.&amp;rdquo; (Article 12(4)).&lt;/p&gt;
&lt;p&gt;Beyond codifying existing expectations of arbitrators, parties to ICC disputes will now be required, at the outset of the proceedings, to provide a list of persons and entities that prospective arbitrators should consider when assessing potential conflicts, together with the reasons such persons or entities may be relevant. The new rule will state:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;To assist prospective arbitrators and arbitrators in complying with their disclosure obligations, at the time of filing their respective Request, Answer, Request for Joinder, Answer to a Request for Joinder or request for an extension of time for submitting an Answer under Article 6(2), each party must submit to the Secretariat a list of persons and entities which they believe the prospective arbitrators and arbitrators should consider and the reasons thereof. (Article 12(5))&lt;/p&gt;
&lt;p&gt;These updates should encourage broader and earlier disclosures by arbitrators and more proactive conflict identification by parties. Taken together, these changes may have the effect of increasing the number of arbitrator challenges made by parties, though there is no reason to expect that there will be a parallel increase in &lt;em&gt;successful&lt;/em&gt; challenges. And greater disclosure at the outset of proceedings may also serve to further insulate ICC awards from post-award judicial challenges on arbitrator partiality grounds. &lt;/p&gt;
&lt;p&gt;More practically, the changes to the rules will raise the burden on parties and arbitrators to meet the ICC&amp;rsquo;s disclosure requirements. Companies frequently engaged in ICC arbitration should consider proactively implementing internal procedures to identify relevant affiliates, stakeholders, and funding arrangements to facilitate compliance with the new requirements and reduce the risk of later-stage conflict-related issues.&lt;/p&gt;
&lt;h2&gt;Part 2: Moving Beyond Mandatory Terms of Reference&lt;/h2&gt;
&lt;p&gt;One of the most significant procedural changes in the 2026 Rules is the removal of mandatory Terms of Reference in standard ICC arbitrations, though tribunals retain discretion to use them as a case management tool. Historically, Terms of Reference have been a distinctive feature of ICC arbitration, serving at the outset of a dispute to formally confirm the parties&amp;rsquo; consent to arbitrate, record key procedural agreements, and define the scope of the dispute. Successive revisions have steadily reduced their formality, and the ICC reports that, in the more than 1,000 cases administered since 2017 under the Expedited Procedure Provisions &amp;mdash; under which the Terms of Reference were already optional &amp;mdash; fewer than 25 tribunals have elected to draw them up. &lt;/p&gt;
&lt;p&gt;With Terms of Reference no longer mandatory, the initial Case Management Conference (CMC) becomes the central procedural milestone for structuring the proceedings. The ICC has indicated that tribunals may wish to use Procedural Order No. 1 to record matters previously included in the Terms of Reference, such as the identification of the parties, confirmation of jurisdiction, and the applicable law. Importantly, the initial CMC also becomes the cut-off for introducing new claims as a matter of right. If a party wishes to introduce new claims after the initial CMC, they must receive authorization from the tribunal, which will consider the nature of the new claims, the stage of the proceedings, any cost implications, and any other relevant circumstances.&lt;/p&gt;
&lt;p&gt;The 2026 Rules also revise the time limit for rendering the final award. The longstanding default of six months from the last signature of the Terms of Reference is replaced by a tailored approach under Article 34, pursuant to which the President of the ICC Court fixes, and may extend, the time limit based on the procedural timetable created during the initial CMC or a reasoned request from the tribunal.&lt;/p&gt;
&lt;p&gt;The removal of the ICC&amp;rsquo;s distinctive requirement of a Terms of Reference, as well as the changes to the fixing of a final award deadline, reflects a broader shift in the revised ICC Rules toward increased procedural flexibility. While the Terms of Reference can serve an important function as a formal undertaking among the parties and tribunal regarding the scope and conduct of the dispute, for smaller or faster-moving disputes, they also could impose unneeded time and costs on all sides of the dispute. In the same vein, the newly flexible award time limit reflects the variable complexity of ICC disputes and the corresponding needs of the parties; in practice, the six-month time limit was frequently extended at the request of the parties and/or the tribunal. The change to the rules should lighten the administrative load associated with the award deadline by allowing for the fixing of a realistic deadline, with input by the parties and tribunal, at the outset.&lt;/p&gt;
&lt;h2&gt;Part 3: Expedited Procedure Provisions and Emergency Arbitration&lt;/h2&gt;
&lt;p&gt;Expanding the scope of cases eligible for expedited procedures, the ICC announced an increase to the monetary threshold for automatic application of the expedited procedure from $3 million to $4 million. This increase to the threshold should expand the number of disputes eligible for expedited procedures, especially considering the ICC states that in 2025, over 40% of their cases did not exceed $4 million.&lt;/p&gt;
&lt;p&gt;Perhaps even more significantly, the ICC has also previewed revisions relating to emergency arbitration and case management aimed at facilitating more efficient proceedings in urgent disputes. The new rules will allow emergency proceedings to be initiated not only against signatories to an arbitration agreement and their successors, as under the existing rules, but also against &amp;ldquo;any party for which the President is satisfied, based on information in the Application, that an arbitration agreement binding such party may exist.&amp;rdquo; The ICC clarified that because of this rule, the President of the ICC Court &amp;ldquo;is empowered to take a decision &amp;hellip; based on the information submitted as part of the file, as to whether an arbitration agreement &lt;em&gt;may&lt;/em&gt; bind the party or parties.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In addition, the new Emergency Arbitration Provisions &amp;ldquo;acknowledge preliminary orders and provide that, at any stage of emergency arbitrator proceedings, a party may request a preliminary order directing another party not to frustrate the purpose of the application.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The expansion of expedited proceedings may place parties in eligible disputes under greater pressure to present their cases more efficiently and at an earlier stage of proceedings. In drafting and negotiating arbitration clauses, parties should consider the trade-offs inherent in such procedures and whether to opt out of them altogether. In doing so, parties should weigh the greater speed, cost control, and access to urgent relief under the expedited procedures against their potential downsides, including the requirement of a sole arbitrator (and concordant loss of the ability to nominate one&amp;rsquo;s own arbitrator) and diminished procedural opportunities to develop evidence and present one&amp;rsquo;s case. &lt;/p&gt;
&lt;p&gt;Meanwhile, the changes to emergency arbitration could significantly enhance its importance. The &lt;em&gt;prima facie&lt;/em&gt; standard to be deployed in determining whether a respondent is bound by the arbitration agreement will allow emergency relief to be sought and ordered against a wider range of relevant parties, and emergency arbitrators have, at the same time, been granted greater express authority to make additional orders to preserve the &lt;em&gt;status quo&lt;/em&gt;. Assuming the enforceability of these expanded emergency procedures, the ICC&amp;rsquo;s rule changes provide parties in need of urgent relief through arbitration a substantially expanded toolkit for obtaining it. &lt;/p&gt;
&lt;p style="text-align: center;"&gt;*&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has significant experience serving as counsel in ICC disputes, as well as a number of partners who have served as an arbitrator and in leadership roles at the ICC. Should you face a dispute involving ICC proceedings, or are evaluating the inclusion of an ICC dispute-resolution clause in an agreement, Arnold &amp;amp; Porter can provide expert advice drawing on its experience and in-depth knowledge of the ICC and international commercial arbitration practice more generally.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{58A2C33E-A810-4904-87EE-879314B6763A}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/time-to-learn-the-canadian-two-step</link><a10:author><a10:name>Benjamin Mintz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mintz-benjamin</a10:uri><a10:email>benjamin.mintz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Justin Imperato</a10:name><a10:uri>https://www.arnoldporter.com/en/people/i/imperato-justin</a10:uri><a10:email>justin.imperato@arnoldporter.com</a10:email></a10:author><title>Time to Learn the “Canadian Two-Step”?</title><description>Reverse vesting orders (RVOs) have become a significant restructuring mechanism in Canadian insolvency proceedings, allowing unwanted liabilities and assets to be transferred into a separate &amp;ldquo;ResidualCo&amp;rdquo; while preserving the debtor&amp;rsquo;s core business, licenses, and tax attributes for acquisition by a purchaser. In &lt;em&gt;In re Iovate Health Sciences International Inc.&lt;/em&gt;, the U.S. Bankruptcy Court for the Southern District of New York recognized and enforced a Canadian RVO under Chapter 15, holding that the structure did not violate U.S. public policy, that creditors were sufficiently protected, and that nonconsensual third-party releases approved in Canada could be enforced in the U.S. despite the Supreme Court&amp;rsquo;s &lt;em&gt;Purdue Pharma&lt;/em&gt; decision limiting such releases in Chapter 11 cases. The decision is notable for providing one of the first detailed U.S. analyses of RVOs and for reinforcing the growing view that Chapter 15 proceedings permit broader cross-border restructuring tools than those available under domestic Chapter 11 practice.</description><pubDate>Tue, 26 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;/p&gt;
&lt;p&gt;Reverse vesting orders (RVOs) have emerged in Canada as an important restructuring tool for debtors. Instead of a traditional sale, debtors&amp;rsquo; &lt;em&gt;unwanted&lt;/em&gt; liabilities and assets are reverse vested out of the debtor company into a newly created entity, &amp;ldquo;ResidualCo,&amp;rdquo; leaving the clean, viable business and its assets in the debtor company for the purchaser to acquire. RVOs have sparked fierce debate. Critics argue they can be used unfairly to shed pension obligations, environmental liabilities, and employee claims in ways that prejudice stakeholders, allowing purchasers to cherry-pick assets to the detriment of creditors.&lt;/p&gt;
&lt;p&gt;In &lt;em&gt;In re Iovate Health Sciences International Inc.&lt;/em&gt;,[[N:Case No.25-11958 (MG), ECF No. 108 (Bankr. S.D.N.Y. May 12, 2026) (&lt;em&gt;Iovate&lt;/em&gt;).]] one of the first published opinions to analyze the enforceability of Canadian RVOs in the U.S. under Chapter 15 of the U.S. Bankruptcy Code (the Bankruptcy Code), the U.S. Bankruptcy Court for the Southern District of New York (the Bankruptcy Court) granted Iovate Health Sciences International Inc.&amp;rsquo;s (in its capacity as the authorized foreign representative, the Foreign Representative) motion to recognize and enforce an RVO approved by the Ontario Superior Court of Justice (the Canadian Court) in the Iovate debtors&amp;rsquo; Canadian insolvency proceedings.&lt;/p&gt;
&lt;p&gt;The Bankruptcy Court did several notable things in &lt;em&gt;Iovate&lt;/em&gt; when it enforced the Iovate RVO. First, it held that the Iovate RVO did not violate U.S. public policy and that creditor interests had been sufficiently protected in the Canadian insolvency proceedings. Second, it held that the Iovate RVO transaction did not necessitate review under Bankruptcy Code section 363(b),[[N:Bankruptcy Code section 363(b) provides, among other things, that court approval must be obtained before a debtor may sell assets outside of the ordinary course of business. See 11 U.S.C. &amp;sect; 363(b).]] although the Bankruptcy Court did grant section 363(m) good faith purchaser protections to the Purchaser (as defined below).[[N:Bankruptcy Code section 363(m) provides that if a sale of estate property is authorized by the bankruptcy court, and that authorization is later reversed or modified on appeal, the reversal or modification does not affect the validity of the sale to a good faith purchaser, unless the appellant obtained a stay of the sale pending appeal.]] Finally, it recognized nonconsensual third-party releases approved by the Canadian Court in the Iovate RVO, notwithstanding the Supreme Court&amp;rsquo;s decision in &lt;em&gt;Harrington v. Purdue Pharma L.P.&lt;/em&gt;[[N:603 U.S. 204 (2024).]] which held that nonconsensual third-party releases in Chapter 11 plans are not permitted. These notable aspects from &lt;em&gt;Iovate&lt;/em&gt; will be addressed below, along with a discussion on the implications of the decision. But first, we discuss reverse vesting orders, generally, and provide background from the Iovate Canadian insolvency proceeding.&lt;/p&gt;
&lt;h2&gt;Background on Reverse Vesting Orders and &lt;em&gt;Iovate&lt;/em&gt;&lt;/h2&gt;
&lt;p&gt;Section 11 of the Canadian Companies&amp;rsquo; Creditors Arrangement Act (CCAA) confers broad authority on Canadian courts to &amp;ldquo;make any order that it considers appropriate in the circumstances.&amp;rdquo;[[N:R.S.C. 1985, c. C-36, &amp;sect; 11.]] From CCAA section 11, RVOs have emerged in Canadian insolvency practice in the last decade. RVOs employ a reverse vesting structure whereby the debtor cancels all existing shares and issues new shares to a designated purchaser. The purchaser agrees to accept preferred assets and liabilities, while certain excluded assets and liabilities are vested into a newly formed ResidualCo. The purchased company, holding only the assumed assets and liabilities as desired by the purchaser, may then exit the Canadian insolvency proceeding with the ResidualCo being added as a debtor to the proceeding.&lt;/p&gt;
&lt;p&gt;The Bankruptcy Code does not afford debtors and asset purchasers any parallel to RVOs. In cases under Chapter 11 of the Bankruptcy Code, the primary mechanism for asset sales is section 363, which works in the opposite direction from an RVO &amp;mdash; the debtor transfers assets out to a purchaser free and clear of liens and claims, with liabilities (other than expressly assumed ones) staying behind in the estate. There&amp;rsquo;s no statutory equivalent to the Canadian RVO structure where the liabilities are transferred out and the purchaser acquires the existing corporate shell with its licenses, tax attributes, and regulatory history intact. One could, theoretically, construct a plan that creates a ResidualCo entity, vests unwanted liabilities into it, and distributes the cleaned-up debtor&amp;rsquo;s equity to a purchaser, thereby economically replicating the RVO structure. Nothing in the Bankruptcy Code expressly prohibits this approach, though engaging in the plan process would decrease the speed at which the sale may occur, potentially resulting in the depreciation of the entity and its assets.&lt;/p&gt;
&lt;p&gt;In recent years, some U.S. companies have tried to employ a similar process in advance of a bankruptcy filing, the so-called Texas two-step, which is a corporate restructuring maneuver that uses Texas&amp;rsquo; divisive merger statute[[N:See Tex. Bus. Orgs. Code &amp;sect;&amp;sect; 10.001 &lt;em&gt;et seq.&lt;/em&gt;]] to shield solvent companies from mass tort liability. In the first step, a parent company uses a Texas divisive merger to split into two entities &amp;mdash; one retaining the valuable assets and the other bearing the tort liabilities. In the second step, that liability-burdened entity commences a Chapter 11 bankruptcy case, which automatically stays all litigation against that liability-burdened spinoff.[[N:Bankruptcy courts have treated the Texas two-step with increasing skepticism, particularly after the Third Circuit&amp;rsquo;s rulings in the Johnson &amp;amp; Johnson (J&amp;amp;J) talc litigation. The Third Circuit held that J&amp;amp;J&amp;rsquo;s specially created subsidiary, LTL Management, was not eligible for bankruptcy protection because it was not in genuine financial distress &amp;mdash; reasoning that good faith requires distress that is immediate, imminent, and apparent. After J&amp;amp;J refiled with an estimated $61.5 billion settlement offer, the Bankruptcy Court for the District of New Jersey again dismissed the case as filed in bad faith, and the Bankruptcy Court for the Southern District of Texas subsequently rejected J&amp;amp;J&amp;rsquo;s third attempt as recently as March 2025, reaffirming that bankruptcy laws are for distressed businesses rather than a liability management tool for solvent corporations. By contrast, other users of the strategy &amp;mdash; most notably Georgia-Pacific&amp;rsquo;s Bestwall entity, which offloaded asbestos liabilities in 2017 &amp;mdash; have as yet survived in other circuits but have to date not achieved a successful confirmed plan. On the legislative front, a bipartisan group of lawmakers introduced the Ending Corporate Bankruptcy Abuse Act in July 2024, which was reintroduced in December 2024, and would instruct courts to presume bad faith in Texas two-step filings and prohibit extending the automatic stay to non-bankrupt affiliates &amp;mdash; though the bill has yet to advance.]] In addition, the debtor entity may be able to extend the stay to apply to all non-debtor affiliates.&lt;/p&gt;
&lt;p&gt;Iovate Health Sciences International Inc. and its affiliated debtors commenced insolvency proceedings in Canada on September 5, 2025.[[N:The insolvency proceedings were initially commenced under Canada&amp;rsquo;s Bankruptcy and Insolvency Act (BIA). The BIA proceedings were later converted to a CCAA proceeding by order of the Canadian Court on October 31, 2025.]] The Canadian Court appointed KSV Restructuring Inc. (the Monitor) as independent monitor and approved a Sale and Investment Solicitation Process (SISP) conducted by the Monitor with the assistance of a sales agent. The SISP proceeded and later the Monitor selected the bid submitted by 1001542267 Ontario Inc. (the Purchaser), a newly formed entity, as the superior bid. The Purchaser&amp;rsquo;s winning bid was implemented through a Subscription Agreement (the Subscription Agreement), dated April 2, 2026, between the Purchaser and Xiwang Iovate Holdings Company Limited (the Purchased Company).&lt;/p&gt;
&lt;p&gt;The parties structured the sale as a reverse vesting transaction whereby the Purchaser subscribed for and acquired 100 new common shares in the Purchased Company, while all existing shares were cancelled for no consideration. Certain identified &amp;ldquo;Excluded Assets,&amp;rdquo; &amp;ldquo;Excluded Contracts,&amp;rdquo; and &amp;ldquo;Excluded Liabilities&amp;rdquo; (collectively, Excluded Property) were vested out to a newly formed ResidualCo, leaving the Purchased Company holding only the preferred assets and liabilities that the Purchaser wished to retain.&lt;/p&gt;
&lt;p&gt;The reverse vesting structure was necessitated by the debtors&amp;rsquo; possession of non-transferable regulatory licenses required to import goods and sell products in Canada, US$114 million in non-capital losses eligible to be carried forward only if retained by the existing entity, and contracts that could be maintained more efficiently through the existing legal entity than through an asset sale. The Canadian Court approved the Iovate RVO on April 16, 2026, including the Subscription Agreement and third-party releases in it, finding that the structure satisfied all applicable CCAA requirements and produced an economic outcome at least as favorable as any available alternative.&lt;/p&gt;
&lt;p&gt;The Foreign Representative filed a Chapter 15 petition in the Bankruptcy Court to prevent the Iovate debtors&amp;rsquo; stakeholders and judgment creditors from commencing or proceeding with actions in the U.S. that would disrupt Iovate&amp;rsquo;s restructuring process. The Foreign Representative obtained recognition of the Canadian CCAA proceeding as a foreign main proceeding under Bankruptcy Code section 1517, and subsequently moved for an order that: (i) recognized and enforced the Iovate RVO under Bankruptcy Code sections 1522, 1521, and 1507; or, alternatively, (ii) authorized and approved the Iovate RVO under Bankruptcy Code sections 363, 1520, and 1521.&lt;/p&gt;
&lt;h2&gt;The &lt;em&gt;Iovate&lt;/em&gt; Decision&lt;/h2&gt;
&lt;p&gt;Bankruptcy Code section 1521(a)(7) gives courts broad discretion to provide to foreign representatives &amp;ldquo;any appropriate relief that would further the purposes of chapter 15 and protect the debtor&amp;rsquo;s assets and the interests of creditors,&amp;rdquo;[[N:&lt;em&gt;In re Asbestos Corp. Ltd.&lt;/em&gt;,674 B.R. 855, 868 (Bankr. S.D.N.Y. 2025); see 11 U.S.C. &amp;sect; 1521(a)(7).]] including relief that would not be available in a Chapter 11 case, &amp;ldquo;provided that such assistance is consistent with the principles of comity and satisfies fairness considerations set forth in Section 1507(b).&amp;rdquo;[[N:&lt;em&gt;In re Rede Energia S.A.&lt;/em&gt;, 515 B.R. 69, 90 (Bankr. S.D.N.Y. 2014).]] This broad grant is constrained only by the requirement in Bankruptcy Code section 1522(a) that creditor interests be &amp;ldquo;sufficiently protected,&amp;rdquo; and that the relief not violate U.S. public policy pursuant to Bankruptcy Code section 1506.[[N:&lt;em&gt;In re Cozumel Caribe S.A. de C.V.&lt;/em&gt;, 482 B.R. 96, 113 (Bankr. S.D.N.Y. 2012).]]&lt;/p&gt;
&lt;p&gt;Many U.S. bankruptcy courts have, without objection, enforced Canadian RVOs without accompanying opinions explaining the court&amp;rsquo;s reasoning.[[N:See, e.g., &lt;em&gt;In re Voxtur Analytics Corp.&lt;/em&gt;, No. 25 11996 (JKS) (Bankr. D. Del. Feb. 13, 2026); &lt;em&gt;In re The Lion Elec. Co.&lt;/em&gt;, No. 24-18898 (DDC) (Bankr. N.D. Ill. June 26, 2025); &lt;em&gt;In re Chesswood Grp.&lt;/em&gt;, No. 24-12454 (CTG) (Bankr. D. Del. Mar. 24, 2025); &lt;em&gt;In re 9139249 Canada Inc.&lt;/em&gt;, No. 24-19627 (VZ) (Bankr. C.D. Cal. Jan. 10, 2025); &lt;em&gt;In re Elevation Gold Mining Corp.&lt;/em&gt;, No. 24-06359 (Bankr. D. Ariz. Dec. 30, 2024); &lt;em&gt;In re Endoceutics Inc.&lt;/em&gt;, No. 22-11641 (Bankr. D. Mass. Oct. 12, 2023); &lt;em&gt;In re Just Energy Grp.&lt;/em&gt;, No. 21-30823 (Bankr. S.D. Tex., Dec. 1, 2022).]] In one notable instance, though, the Delaware bankruptcy court published a decision that recognized a Canadian RVO that was presented without objection for enforcement, and cautioned against applying the decision as precedent, citing uncertainty in how the court would, in the face of an objection, view an RVO that redeems and cancels existing equity for no consideration and vests out to a ResidualCo the debtor&amp;rsquo;s liabilities.[[N:&lt;em&gt;In re Goli Nutrition Inc.&lt;/em&gt;, Case No. 10438, 2024 WL 1748460, at * 2 (Bankr. D. Del. Apr. 23, 2024) (&lt;em&gt;Goli Nutrition&lt;/em&gt;) (&amp;ldquo;I stated that I would enforce the order as there were no objections to the transaction as a whole or its structure. Notice was provided to all parties, including shareholders whose stock is being redeemed and cancelled for no consideration, and those who may hold liabilities that are being vested out to Residual Co. I must emphasize, however, that I do not know how I would rule on a similar reverse vesting transaction if there were objections. So, I cannot stress enough that the order I enter should not be cited in future motions for the proposition that U.S. courts have unconditionally approved such transactions.&amp;rdquo;).]]&lt;/p&gt;
&lt;p&gt;The Bankruptcy Court enforced the Iovate RVO pursuant to Bankruptcy Code sections 1522 and 1521.[[N:In &lt;em&gt;Iovate&lt;/em&gt;, one of the debtors&amp;rsquo; creditors, TSI Group Co., Ltd., filed a limited objection to the Foreign Representative&amp;rsquo;s motion to enforce the RVO, citing Iovate&amp;rsquo;s failure to confirm that it would assume existing contractual agreements with TSI or pay the cure amounts owed to TSI. TSI, however, subsequently withdrew its limited objection.]] Applying Bankruptcy Code section 1522, the Bankruptcy Court held that creditor interests were sufficiently protected for two reasons. First, the Canadian Court had specifically found that no stakeholder was worse off under the Iovate RVO structure than under any available alternative. Second, the Monitor, an independent officer with court-appointed oversight authority, had conducted the SISP, ensuring objective and fair administration of the process. Critically, the Bankruptcy Court emphasized that the Iovate RVO did not extinguish any creditor&amp;rsquo;s claim; all such claims would survive against either the reorganized principal entities or ResidualCo, with the same nature and priority as before the Iovate RVO.&lt;/p&gt;
&lt;p&gt;The Bankruptcy Court further held that recognition and enforcement of the Iovate RVO did not violate the public policy exception of Bankruptcy Code section 1506, which the Bankruptcy Court held should be construed narrowly to apply only to actions contrary to the &amp;ldquo;most fundamental policies of the United States.&amp;rdquo;[[N:&lt;em&gt;In re Ephedra Prods. Liab. Lit.&lt;/em&gt;, 349 B.R. 333, 336 (S.D.N.Y. 2006) (citing H.R. Rep. No. 109&amp;ndash;31(I), at 109, as reprinted in 2005 U.S.C.C.A.N. 88, 172).]] The Bankruptcy Court reasoned that, if even the denial of a jury trial right in a foreign proceeding does not offend U.S. public policy when a fair and impartial proceeding is offered,[[N:See id.]] then a reverse vesting structure that preserves creditor claims certainly does not rise to that level. Given its findings under Bankruptcy Code sections 1522 and 1521, the Bankruptcy Court did not determine whether recognition was also warranted under section 1507.&lt;/p&gt;
&lt;p&gt;The Foreign Representative had alternatively sought approval of the RVO transaction under Bankruptcy Code section 363, which applies by operation of section 1520(a)(2) to transfers of U.S.-sited property in a recognized foreign main proceeding. The Bankruptcy Court declined to conduct a section 363 analysis on two grounds. First, following &lt;em&gt;Goli Nutrition&lt;/em&gt;, the Bankruptcy Court held that the issuance of new shares to the Purchaser is not a &amp;ldquo;sale&amp;rdquo; of property within the meaning of section 363. Unlike a stock sale, in which a debtor sells already-issued shares, the reverse vesting structure involves the issuance of newly created shares; no existing estate property is transferred to the Purchaser. Second, with respect to the transfer of Excluded Property to ResidualCo &amp;mdash; which could potentially implicate section 363 &amp;mdash; the Foreign Representative represented on May 6, 2026, at a hearing, that no physical assets currently located in the U.S. would constitute Excluded Property. Accordingly, no transfer of property within the territorial jurisdiction of the U.S. would occur, and Bankruptcy Code section 1520(a)(2) was not triggered. Notably, notwithstanding its declination to review the RVO transaction under section 363(b), the Bankruptcy Court held that the Purchaser was entitled to the good faith protections of section 363(m) where the Monitor confirmed that the Purchaser was unrelated to the debtors under section 36 of the CCAA, the SISP produced broad market canvassing, and there was no evidence of fraud or collusion in the bidding process.&lt;/p&gt;
&lt;p&gt;Finally, the Bankruptcy Court recognized nonconsensual third-party releases approved by the Canadian Court, notwithstanding the Supreme Court&amp;rsquo;s decision in &lt;em&gt;Purdue&lt;/em&gt;, which held that nonconsensual third-party releases in Chapter 11 plans are not permitted. Relying on &lt;em&gt;In re Credito Real, S.A.B. de C.V.&lt;/em&gt;[[N:670 B.R. 150 (Bankr. D. Del. 2025) (&lt;em&gt;Credito Real&lt;/em&gt;).]] and &lt;em&gt;In re Odebrecht Engenharia e Constru&amp;ccedil;&amp;atilde;o S.A.&lt;/em&gt;,[[N:669 B.R. 457 (Bankr. S.D.N.Y. 2025) (&lt;em&gt;Odebrecht&lt;/em&gt;).]] the Bankruptcy Court held that &lt;em&gt;Purdue&lt;/em&gt;&amp;rsquo;s holding is limited to Chapter 11 cases. According to the Bankruptcy Court, the releases here were permissible because they were narrowly tailored and limited to claims arising from or relating to the Subscription Agreement, the RVO, and the transactions contemplated by the RVO and Subscription Agreement and expressly excluded claims for fraud or willful misconduct. This scope, according to the Bankruptcy Court, was consistent with releases approved in &lt;em&gt;Odebrecht&lt;/em&gt;, and the Bankruptcy Court found them properly balanced against stakeholder interests. The Bankruptcy Court also notably observed that failing to enforce the releases in the U.S. would create an unequal playing field, giving U.S.-based creditors rights that Canadian creditors did not have, thereby undermining the comity-based framework of Chapter 15.&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The &lt;em&gt;Iovate&lt;/em&gt; decision is significant in two respects. First, it is among the first published decisions to provide a full legal analysis of a reverse vesting order, building on the sparse precedent from the Delaware bankruptcy court in &lt;em&gt;Goli Nutrition&lt;/em&gt; and the broader body of unpublished RVO recognition orders from courts around the country. The Bankruptcy Court&amp;rsquo;s detailed treatment of the RVO mechanism, including its Canadian statutory basis, the approval factors, and the distinction from the Texas two-step, provides a framework that future courts and practitioners can draw upon.&lt;/p&gt;
&lt;p&gt;Second, the decision reinforces the post-&lt;em&gt;Purdue&lt;/em&gt; consensus that is emerging in Chapter 15 cases: the Supreme Court&amp;rsquo;s prohibition on nonconsensual third-party releases in Chapter 11 plans does not extend to Chapter 15 recognition proceedings, where the broader statutory grants in Bankruptcy Code sections 1521 and 1507 permit courts to enforce such releases when creditor interests are sufficiently protected. While &lt;em&gt;Iovate&lt;/em&gt;&amp;rsquo;s holding is consistent with &lt;em&gt;Credito Real&lt;/em&gt; and &lt;em&gt;Odebrecht&lt;/em&gt; and reflects a growing judicial consensus that &lt;em&gt;Purdue&lt;/em&gt;&amp;rsquo;s reasoning does not curtail the distinctly broader tools available in ancillary cross-border proceedings, we expect &lt;em&gt;Purdue&lt;/em&gt;&amp;rsquo;s applicability to Chapter 15 proceedings to be a continuing source of debate. We also expect to see, where obtaining third-party releases are critical to the success of a company&amp;rsquo;s efforts to reorganize, more companies pursue foreign restructurings in Canada, the United Kingdom, and other locales where nonconsensual third-party releases are enforceable, with such companies thereafter attempting to obtain recognition in the U.S. under Chapter 15 to enforce those third-party releases.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{89A351EC-E722-47A2-B9A1-ED68AA0F275F}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/05/navigating-antitrust-compliance-for-consumer-products-retail-companies</link><a10:author><a10:name>Matthew Tabas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tabas-matthew</a10:uri><a10:email>matthew.tabas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Wilson D. Mudge</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mudge-wilson-d</a10:uri><a10:email>Wilson.Mudge@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Esther Ha Yoon Sohn</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sohn-esther</a10:uri><a10:email>esther.sohn@arnoldporter.com</a10:email></a10:author><title>Navigating Antitrust Compliance for Consumer Products &amp; Retail Companies</title><description>Join Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products &amp;amp; Retail Industry Group for the next program in our Consumer Products &amp;amp; Retail Navigator webinar series, focused on how to identify and avoid common antitrust traps in your pricing, contracting, and distribution practices.</description><pubDate>Thu, 21 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Join Arnold &amp;amp; Porter&amp;rsquo;s Consumer Products &amp;amp; Retail Industry Group for the next program in our Consumer Products &amp;amp; Retail Navigator webinar series, focused on how to identify and avoid common antitrust traps in your pricing, contracting, and distribution practices.&lt;/p&gt;
&lt;p&gt;Antitrust risk is present in many everyday business decisions, and the consequences of missteps can be severe. Government enforcers and private plaintiffs continue to scrutinize pricing practices, distribution arrangements, and contracting strategies across industries. This legal environment requires companies to build robust compliance practices into their core business operations.&lt;/p&gt;
&lt;p&gt;During our program, we will walk through how to avoid common antitrust traps and what to do about them, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Pricing practices and common pitfalls&lt;/li&gt;
    &lt;li&gt;Contracting practices and antitrust compliance considerations&lt;/li&gt;
    &lt;li&gt;Distribution strategies and antitrust risk&lt;/li&gt;
    &lt;li&gt;Best practices for mitigating antitrust exposure&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;This is a practical session designed to help consumer products and retail companies identify exposure and prioritize next steps.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1FD6B1FD-45D2-4079-843A-A2DE3C1D5FF8}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/daily-journal-names-deborah-fishman-and-tom-magnani-to-2026-top-intellectual-property-lawyers-list</link><title>Daily Journal Names Deborah Fishman and Tom Magnani to 2026 ‘Top Intellectual Property Lawyers’ List</title><description>Arnold &amp;amp; Porter partners Deborah Fishman and Tom Magnani were named to &lt;em&gt;Daily Journal&lt;/em&gt;&amp;rsquo;s list of &amp;ldquo;Top Intellectual Property Lawyers 2026.&amp;rdquo;</description><pubDate>Thu, 21 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partners Deborah Fishman and Tom Magnani were named to &lt;em&gt;Daily Journal&lt;/em&gt;&amp;rsquo;s list of &amp;ldquo;Top Intellectual Property Lawyers 2026.&amp;rdquo; The annual list recognizes an outstanding group of California-based attorneys whose achievements over the past year have significantly influenced the field of intellectual property.&lt;/p&gt;
&lt;p&gt;Deborah, recognized on the list since 2022, was commended for her nearly 30 years of representing biopharmaceutical and medical device companies in high-stakes patent and commercial disputes, including cases exceeding $1 billion in value and matters reaching the U.S. Supreme Court. &lt;em&gt;Daily Journal&lt;/em&gt; emphasized her long-standing representation of Regeneron in defending the patents protecting EYLEA, its flagship ophthalmology biologic, where Deborah and the Arnold &amp;amp; Porter team defended nine&lt;em&gt; inter partes&lt;/em&gt; review and post-grant review proceedings while simultaneously managing two Federal Circuit appeals and parallel foreign matters.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Daily Journal&lt;/em&gt; highlighted Tom, head of the firm's Technology Transactions practice and co-chair of the firm&amp;rsquo;s Technology &amp;amp; Media industry group and Artificial Intelligence (AI) group, for his work at the forefront of AI and intellectual property law. Tom was recognized for his representation of AI-developer Anthropic in cutting-edge copyright matters, as well as for his decades of experience navigating complex, multi-stakeholder transactions, including negotiating the deal that brought classic Peanuts television specials to Apple TV+, and representing Middle-earth Enterprises in the sale of rights to &lt;em&gt;The Lord of the Rings&lt;/em&gt; and &lt;em&gt;The Hobbit&lt;/em&gt;. &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{6D2A081E-56A8-4E54-99A2-14A1E6FF3053}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/massachusetts-lawyers-weekly-recognizes-josh-barlow-as-a-2026-leader-in-the-law</link><title>Massachusetts Lawyers Weekly Recognizes Josh Barlow as a 2026 Leader in the Law</title><description>Arnold &amp;amp; Porter partner Josh Barlow has been selected as a 2026 Massachusetts Leaders in the Law honoree by &lt;em&gt;Massachusetts Lawyers Weekly&lt;/em&gt;.</description><pubDate>Thu, 21 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Josh Barlow has been selected as a 2026 Massachusetts Leaders in the Law honoree by &lt;em&gt;Massachusetts Lawyers Weekly&lt;/em&gt;. The annual award celebrates attorneys throughout the state who have demonstrated exceptional legal skill, sustained professional leadership, and meaningful contributions to the communities they serve.&lt;/p&gt;
&lt;p&gt;Josh is a seasoned trial lawyer whose nearly two decades of litigation experience span complex commercial disputes, product liability, and antitrust matters, with a particular focus on life sciences clients. He has litigated cases to verdict before juries, judges, and arbitrators in federal and state courts across the country and in both domestic and international arbitration, bringing the same courtroom discipline to matters ranging from medical device design and manufacture to nationwide mass tort and consumer class action defense.&lt;/p&gt;
&lt;p&gt;His 2026 recognition builds on the successful outcome in &lt;em&gt;Cynosure LLC, et al. v. Reveal Lasers LLC, et al.&lt;/em&gt;, named one of &lt;em&gt;Massachusetts Lawyers Weekly&lt;/em&gt;'s 2025 Top Verdicts. Josh, and Arnold &amp;amp; Porter partners Dipanwita Amar, Matthew Diton, Joseph Farris, and Fred Kelly tried the case and secured a unanimous jury verdict for a leading provider of medical aesthetic devices in a non-competition and trade secret case, with the court subsequently doubling the award to approximately $35 million in compensatory and punitive damages, interest, and attorneys&amp;rsquo; fees.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{BF41D89D-1F3E-4FCA-8EC2-3723E0570091}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/inside-oigs-new-cia-template</link><a10:author><a10:name>Gina M. Cavalier</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cavalier-gina-m</a10:uri><a10:email>gina.cavalier@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lisa M. Re</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/re-lisa-m</a10:uri><a10:email>lisa.re@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jaclyn Machometa</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/machometa-jaclyn</a10:uri><a10:email>jaclyn.machometa@arnoldporter.com</a10:email></a10:author><title>Inside OIG’s New CIA Template: What Kinex Means for Life Sciences and Healthcare Compliance</title><description>The 2026 OIG Corporate Integrity Agreement (CIA) for Kinex Medical Company highlights evolving healthcare compliance expectations, emphasizing stronger compliance officer independence, enhanced board oversight, rigorous fair market value documentation, and proactive auditing and monitoring obligations. The agreement also reflects the growing role of generative AI in healthcare compliance programs, signaling that organizations must implement governance controls around AI-driven decision-making while maintaining robust documentation, training, and risk assessment processes to prepare for potential OIG CIA audits and enforcement scrutiny.</description><pubDate>Thu, 21 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;h2&gt;Overview&lt;/h2&gt;
&lt;p&gt;At the Health Care Compliance Association&amp;rsquo;s 2026 Compliance Institute on April 30, 2026, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) publicly walked through its newly modernized Corporate Integrity Agreement (CIA) template,[[N:Office of Inspector General, U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., Modernizing the Corporate Integrity Agreement (CIA) and CIA Website (presentation at Health Care Compliance Association 2026 Compliance Institute, Apr. 30, 2026).]] using the Kinex Medical Company CIA, executed on March 2, 2026, as an example.[[N:&lt;a rel="noopener noreferrer" href="https://oig.hhs.gov/compliance/corporate-integrity-agreements/browse-cias/kinex-medical-company-llc/" target="_blank"&gt;Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Kinex Medical Company, LLC&lt;/a&gt; (Mar. 2, 2026).]] The new template carries forward the seven elements of an effective compliance program that have long anchored OIG&amp;rsquo;s guidance, while introducing substantive enhancements that signal where the agency&amp;rsquo;s expectations are heading.&lt;/p&gt;
&lt;p&gt;Although a CIA technically binds only the entity that signs it, OIG has long treated the CIA as a vehicle for publicly articulating its expectations across the life sciences and healthcare industry. Together with OIG&amp;rsquo;s updated General Compliance Program Guidance[[N:Office of Inspector General, U.S. Dep&amp;rsquo;t of Health &amp;amp; Human Servs., &lt;a rel="noopener noreferrer" href="https://oig.hhs.gov/compliance/general-compliance-program-guidance/" target="_blank"&gt;General Compliance Program Guidance&lt;/a&gt; (Nov. 2023).]] (and follow-on industry-specific guidance), the Kinex CIA offers the clearest picture to date of what OIG considers an effective compliance program. These changes offer meaningful insight into how OIG will likely measure the effectiveness of compliance programs going forward. The discussion that follows summarizes seven enhancements with broad applicability beyond entities operating under a CIA.&lt;/p&gt;
&lt;h2&gt;Compliance Officer: Independent Reporting Lines, Direct Board Access, and Prohibited Dual Roles &lt;/h2&gt;
&lt;p&gt;In the Kinex CIA, OIG substantially elevated the role of the Compliance Officer (CO) and prohibited certain conflicting job functions. Specifically, the CO must report directly to either the CEO or the Board, have direct and independent access to the Board, and possess &amp;ldquo;sufficient stature&amp;rdquo; to interact as an equal with other senior leaders. The CO may not lead or report to the legal or financial functions, provide legal or financial advice, or hold operational responsibility for healthcare delivery, billing and coding, claims submission, medical review, administrative appeals, or contracting. In sum, the revised structure outlined in the new CIA template reflects OIG&amp;rsquo;s view that the CO should function as an independent senior leader, not a part-time function layered onto another role. &lt;/p&gt;
&lt;h2&gt;Internal Reporting: Capturing All Channels and Allowing Direct Access to Compliance&lt;/h2&gt;
&lt;p&gt;The Kinex CIA includes a useful window into what OIG considers the hallmarks of a functioning internal reporting system, echoing similar elements included in OIG's General Compliance Program Guidance. In particular, OIG highlights the importance of tracking a wide range of internal reports &amp;mdash; including emails, manager escalations, and ethics inbox messages, in addition to formal complaints made to an ethics hotline. OIG also emphasizes that at least one of these channels should allow employees to reach the compliance function directly, without having to route their concerns through a supervisor or the operational chain of command, so that reports cannot be filtered or diverted before reaching compliance. &lt;/p&gt;
&lt;h2&gt;Board Oversight: Independent Members, Quarterly Executive Sessions, and an Independent Compliance Expert&lt;/h2&gt;
&lt;p&gt;The CIA now requires an entity&amp;rsquo;s Board to include at least one independent member &amp;mdash; meaning a non-owner, non-employee, and non-executive &amp;mdash; closing a structural gap that allowed all-insider boards at many privately held and private equity-backed entities. The Board must also meet at least quarterly in executive session with the CO, without entity leaders, counsel, or employees present. Further emphasizing the importance of the Board&amp;rsquo;s role in compliance, OIG formalized the Board Compliance Expert as a standard requirement: the Board must retain an independent expert to evaluate program effectiveness, and the Board must respond with a written report and an approved corrective action plan. Together, these requirements signal that Board oversight cannot rest on management&amp;rsquo;s representations alone.&lt;/p&gt;
&lt;h2&gt;Arrangements With Healthcare Professionals and Organizations (HCPs): Verification That Services Are Actually Performed and Resources Actually Used&lt;/h2&gt;
&lt;p&gt;OIG is moving beyond paper compliance and now expects active verification that arrangements are functioning as documented. Tracking service and activity logs to confirm that parties are performing the services required, and monitoring actual use of leased space, supplies, devices, equipment, and other patient care items for consistency with the arrangement&amp;rsquo;s terms, are key aspects of verification expected by OIG. The Kinex CIA also directs the CO to audit &amp;mdash; not merely review &amp;mdash; compliance with these requirements annually, and to report results to the Compliance Committee. These shifts reflect OIG&amp;rsquo;s expectation that compliance programs answer not only whether a control exists, but whether it works.&lt;/p&gt;
&lt;h2&gt;Fair Market Value: Expanded Documentation and an Ongoing Reassessment Obligation&lt;/h2&gt;
&lt;p&gt;The new CIA template introduces more stringent standards for assessing and documenting fair market value (FMV), offering OIG's most direct guidance to date on this important topic. Through these enhancements, OIG has substantially expanded the documentation expectations around FMV determinations for arrangements with referral sources, HCPs, and customers. Entities must document the FMV amount or range, the corresponding time period, the date of completion, the parties that performed the valuation, and the names and positions of personnel involved. Importantly, entities must document FMV not only before signing or renewing an arrangement, but also during its pendency, as appropriate &amp;mdash; meaning FMV is no longer a one-time analysis but a continuing obligation. For multi-year arrangements, entities will need new processes to revisit FMV over the life of the arrangement.&lt;/p&gt;
&lt;h2&gt;Risk Assessment: A Prescribed Five-Step Methodology Owned by the Compliance Committee &lt;/h2&gt;
&lt;p&gt;While prior CIAs required annual risk assessments, OIG&amp;rsquo;s new model now prescribes a specific five-step methodology: identify potential risks, assess their severity, evaluate and prioritize them, develop work plans or audit plans tied to identified risk areas, and monitor the effectiveness of those plans. The Compliance Committee is responsible for implementation and oversight. The methodology transforms the risk assessment into an auditable, repeatable exercise, reflecting OIG&amp;rsquo;s expectation that programs surface and address risks proactively rather than reactively.&lt;/p&gt;
&lt;h2&gt;Generative AI: Defined, Disclosed, and Represented at the Compliance Committee Table&lt;/h2&gt;
&lt;p&gt;For the first time, OIG expressly addressed artificial intelligence (AI) in a CIA. The new model defines Generative Artificial Intelligence (GAI) and, for organizations under a CIA, requires disclosure of whether they used GAI in connection with the compliance program or in preparing reports to OIG; if so, to explain how they used it, and to verify the accuracy of any GAI-assisted content. OIG also expects the Compliance Committee to include leaders from enumerated functional areas, including AI &amp;mdash; recognizing AI as a compliance discipline in its own right. Even outside the CIA context, these provisions offer a useful reference point for how OIG is thinking about AI in compliance.&lt;/p&gt;
&lt;h2&gt;Practical Recommendations&lt;/h2&gt;
&lt;p&gt;The standards reflected in the new CIA template provide a helpful benchmark for self-assessment. Organizations reviewing their programs may want to consider:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Conducting a gap assessment, to compare current structure, policies, and practices against the new template, and prioritize remediation of structural gaps in reporting lines, Board composition, or dual-hatted CO responsibilities.&lt;/li&gt;
    &lt;li&gt;Enhancing internal reporting mechanisms, to ensure the program covers reports through any channel; consider eliminating requirements that employees raise concerns with a supervisor first, and update the disclosure records to capture investigation outcomes, remedial actions, and any external referrals, to the extent the forms do not already.&lt;/li&gt;
    &lt;li&gt;Further empowering the CO, in order to reinforce structural safeguards to support the independence and authority of the CO, consistent with applicable OIG guidance, including appropriate reporting lines and Board access (such as executive sessions), clear separation from operational responsibilities, and formalization through a written charter, while also underscoring the Board&amp;rsquo;s oversight role.&lt;/li&gt;
    &lt;li&gt;Moving from review to verification for arrangements with HCPs, including by assessing whether current tracking systems confirm, on an ongoing basis, that parties are performing the services required and that leased space, equipment, and supplies are being used as the arrangement contemplates; enhancing those systems as needed; and treating FMV as a continuing obligation rather than a one-time analysis.&lt;/li&gt;
    &lt;li&gt;Developing an AI governance policy, to align with the increasing focus on the use of AI in compliance functions, including appropriate validation practices and consideration of AI expertise at the Compliance Committee level. &lt;/li&gt;
    &lt;li&gt;Investing in compliance infrastructure, to sustain core compliance activities, support proactive risk assessment, and embed compliance as a core business function.&lt;/li&gt;
&lt;/ul&gt;
&lt;p style="text-align: center;"&gt;*&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;For questions about this Advisory, please contact the authors.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{386AD988-3E3D-4C38-BCC1-FA6BA4F887BA}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/supreme-court-leaves-price-anderson-act-split-in-place</link><a10:author><a10:name>Lauren Daniel</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/daniel-lauren</a10:uri><a10:email>lauren.daniel@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Burden H. Walker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/walker-burden-h</a10:uri><a10:email>burden.walker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Elise M. Henry</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/henry-elise</a10:uri><a10:email>elise.henry@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sam Kleinman</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kleinman-samuel</a10:uri><a10:email>sam.kleinman@arnoldporter.com</a10:email></a10:author><title>Supreme Court Leaves Price-Anderson Act Split in Place</title><description>On Monday, the Supreme Court rejected a plea to decide a critical question regarding the Price-Anderson Act (the PAA), the federal statute that governs suits stemming from public radiation exposure from nuclear facilities.&amp;nbsp;</description><pubDate>Wed, 20 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On Monday, the Supreme Court rejected a plea to decide a critical question regarding the Price-Anderson Act (the PAA), the federal statute that governs suits stemming from public radiation exposure from nuclear facilities. Last year, in &lt;em&gt;Mazzocchio v. Cotter Corp.&lt;/em&gt; the Eighth Circuit held that plaintiffs in nuclear public liability suits may rely on state-law tort standards of care rather than upon the federal nuclear-safety regulations that five other courts of appeal have held provide the exclusive standard of care in such cases.[[N: &lt;em&gt;Mazzocchio v. Cotter Corp.&lt;/em&gt;, 120 F.4th 565 (8th Cir. 2024).]] Rather than resolving this split in authority, the Supreme Court denied the defendant&amp;rsquo;s petition for certiorari, leaving the Eighth Circuit&amp;rsquo;s precedent, and the circuit split, in place for now.[[N: &lt;em&gt;Cotter Corp. v. Mazzocchio&lt;/em&gt;, No. 24-1001 (U.S. May 18, 2026) (cert. denied).]] As a practical matter, the lingering uncertainty over the governing Price-Anderson standard may incentivize plaintiffs to test the waters in other circuits, and consequently, may risk a chilling of the Trump administration&amp;rsquo;s efforts to &lt;a href="/en/perspectives/blogs/environmental-edge/2025/02/trump-admin-fed-cir-set-to-jumpstart-nuclear-energy"&gt;jumpstart&lt;/a&gt;&amp;nbsp;investment in the nuclear industry.[[N: See, e.g., Lauren Daniel &lt;em&gt;et al.&lt;/em&gt;, &amp;ldquo;Trump Administration, Federal Circuit Set to Jumpstart Investments in Nuclear Industry,&amp;rdquo; &lt;em&gt;Environmental Edge&lt;/em&gt; (Feb. 14, 2025).]]&lt;/p&gt;
&lt;p&gt;As &lt;a href="/en/perspectives/advisories/2024/11/eighth-circuit-creates-circuit-split-under-price-anderson-act"&gt;discussed&lt;/a&gt;&amp;nbsp;in Arnold &amp;amp; Porter&amp;rsquo;s analysis of the Eighth Circuit case,[[N: Lauren Daniel and Sam Kleinman, &amp;ldquo;Eighth Circuit Creates Circuit Split Under Price-Anderson Act, the Statute Government Tort Suits Against Nuclear Operators&amp;rdquo; (Nov. 8, 2024).]] &lt;em&gt;Mazzocchio&lt;/em&gt; arose from claims by Missouri residents that radioactive materials associated with legacy U.S. nuclear activities contaminated local areas and resulted in cancers.[[N: &lt;em&gt;Mazzocchio&lt;/em&gt;, 120 F.4th at 567.]] The defendants in the case moved to dismiss on the grounds that the complaint did not adequately allege violations of federal nuclear radiation-dose standards, which all prior circuits to consider the issue had held to be a necessary element of a public liability claim against nuclear operators.[[N: Id. at 569.]] Specifically, because the Atomic Energy Act gives the federal government exclusive authority over nuclear safety, several courts of appeals had previously held that federal regulations define the exclusive standard of care applicable in these types of suits.[[N: Id.]] These courts have also worried that a jury should not, in applying open-ended state-law standards governing negligence, decide &amp;ldquo;permissible levels of radiation exposure&amp;rdquo; or &amp;ldquo;the adequacy of safety procedures at nuclear plants&amp;rdquo; where the federal government has already brought ample scientific expertise to bear through notice-and-comment rulemaking.[[N: E.g., &lt;em&gt;In re Hanford Nuclear Reservation Litig.&lt;/em&gt;, 534 F.3d 986, 1003 (9th Cir. 2008).]] The &lt;em&gt;Mazzocchio&lt;/em&gt; district court disagreed, however, concluding that plaintiffs could also look to state law in defining the applicable standard of care. Recognizing the split of opinion on the subject, the district court certified the question for interlocutory appeal.[[N: &lt;em&gt;Mazzocchio v. Cotter Corp&lt;/em&gt;, 2023 WL 5831960 (E.D. Mo. Sept. 8, 2023).]]&lt;/p&gt;
&lt;p&gt;The Eighth Circuit affirmed the district court&amp;rsquo;s judgment.[[N: &lt;em&gt;Mazzocchio&lt;/em&gt;, 120 F.4th at 569.]] Looking to the Price-Anderson Act&amp;rsquo;s instruction that state law supplies the substantive rules for decision unless inconsistent with the PAA, the court concluded that state-law tort standards were not displaced merely because they concerned nuclear safety.[[N: Id.]] The decision squarely conflicts with decisions from other circuits holding that federal law supplies the exclusive standard of care.[[N: &lt;em&gt;In re TMI Litig. Cases Consol. II&lt;/em&gt;, 940 F.2d 832, 859 (3d Cir. 1991); &lt;em&gt;accord O&amp;rsquo;Conner v. Commonwealth Edison Co.&lt;/em&gt;, 13 F.3d 1090, 1105 (7th Cir. 1994); &lt;em&gt;Nieman v. NLO, Inc.&lt;/em&gt;, 108 F.3d 1546, 1551-53 (6th Cir. 1997); &lt;em&gt;Roberts v. Fla. Power &amp;amp; Light Co.&lt;/em&gt;, 146 F.3d 1305, 1308 (11th Cir. 1998); &lt;em&gt;Hanford&lt;/em&gt;, 534 F.3d at 1003.]]&lt;/p&gt;
&lt;p&gt;That split made &lt;em&gt;Mazzocchio&lt;/em&gt; an obvious candidate for Supreme Court review. Rule 10 of the Supreme Court&amp;rsquo;s rules consider the existence of a split of authority amongst circuit courts on an important question of federal law a key criterion for certiorari. One of the defendants filed a petition for review, and, as it often does on questions of the interpretation of federal statutes, the Supreme Court asked for the views of the Solicitor General.&lt;/p&gt;
&lt;p&gt;In April 2026, the United States filed a response recommending that the Supreme Court deny certiorari. The government&amp;rsquo;s recommendation was surprising, however, because the brief largely agreed with the petitioners. The government agreed, for example, that the Eighth Circuit decision is wrong and that federal law preempts the application of state law standards of care in PAA suits.[[N: Brief for the United States as Amicus Curiae, &lt;em&gt;Cotter Corp. v. Mazzocchio&lt;/em&gt;, No. 24-1001 (U.S. Apr. 9, 2026), at 12.]] The government also agreed with the petitioners that the Eighth Circuit&amp;rsquo;s decision created a split amongst the courts of appeals. Ultimately, however, the government thought the Supreme Court could wait and review the question at a later time, when it is clearer whether the applicable state-law standards actually differ from the relevant federal standards and whether any such difference would make a practical difference to the outcome in the &lt;em&gt;Mazzocchio &lt;/em&gt;case.[[N: Id. at 20.]]&lt;/p&gt;
&lt;p&gt;The Supreme Court agreed with the United States&amp;rsquo; recommendation and denied certiorari and provided no reasoning. Though the denial does not necessarily signal agreement with the Eighth Circuit, it nonetheless carries real consequences for nuclear litigation and the nuclear industry as a whole. The Solicitor General&amp;rsquo;s tack also suggests the administration is grappling with significant tension and complexity in pursuing its nuclear agenda. Plaintiffs now have additional leeway to test whether &lt;em&gt;Mazzocchio&lt;/em&gt; can be extended beyond its facts to additional theories of state-law liability, to apply &lt;em&gt;Mazzocchio&lt;/em&gt; in circuits that have not yet opined on the question, and/or to test whether the composition of circuits that ruled on the question years ago (in some cases decades ago) might drive a divergence from prior precedent today. That dynamic is likely to persist until the Supreme Court takes up the question in a later case, perhaps after final judgment in &lt;em&gt;Mazzocchio&lt;/em&gt; or after another court of appeals weighs in.&lt;/p&gt;
&lt;p&gt;For nuclear industry operators, the Supreme Court&amp;rsquo;s denial exacerbates legal and business risk. While the relevant Price-Anderson Act claims refer specifically to &amp;ldquo;nuclear incidents,&amp;rdquo; the statutory definition of such claims is expansive and has been interpreted as extending to any claims alleging property damage or personal injury as a result of exposure to nuclear material. Without the shield of federal permit compliance as a complete defense in tort, even nuclear facilities with minimal permitted radiation emissions could be susceptible to burdensome suits. And it is possible that exposure claims with little evidence could be leveraged into suits designed to test these issues. Defendants in Price-Anderson Act cases should continue to preserve the federal-standard-of-care argument early and clearly, even in jurisdictions where the issue appears settled. Defendants should also develop the record on why allowing state-law radiation-safety duties would conflict with the federal nuclear regulatory scheme, particularly where plaintiffs seek to impose obligations different from those established by federal regulators. &lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter has successfully defended Price-Anderson Act suits and helped clients navigate the political complexity associated with operating nuclear facilities. As always, we will continue to monitor developments in litigation affecting the nuclear industry. &lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{34B288BD-4392-4286-9671-8506AF7BC497}</guid><link>https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.dailyjournal.com%2Farticles%2F391607-california-supreme-court-hears-i-gilead-tenofovir-cases-i-weighs-scope-of-duty-to-innovate&amp;data=05%7C02%7CShelby.Mitchell%40arnoldporter.com%7Cf1211dfd23df4a93ad0208deb6b0d0e9%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639149067747740615%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=4Q1w3M6cBkoHhAnYKqWFdaojgQwragqYtZqj%2FdFkfUY%3D&amp;reserved=0</link><a10:author><a10:name>Jocelyn A. Wiesner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/wiesner-jocelyn-a</a10:uri><a10:email>jocelyn.wiesner@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tommy Huynh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/huynh-tommy</a10:uri><a10:email>tommy.huynh@arnoldporter.com</a10:email></a10:author><title>California Supreme Court hears Gilead Tenofovir Cases, weighs scope of 'duty to innovate'</title><pubDate>Wed, 20 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{0BDFD68E-14B4-4DE8-A8B4-365E31AD98EC}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/judah-prero-discusses-new-mexicos-pfas-reporting-requirement-with-chemical-watch-news-insight</link><title>Judah Prero Discusses New Mexico’s PFAS Reporting Requirement with Chemical Watch News &amp; Insight</title><description>Judah Prero, Arnold &amp;amp; Porter Environmental counsel and former Assistant State Attorney General at the Maryland Department of the Environment, was quoted in the &lt;em&gt;Chemical Watch News &amp;amp; Insight&lt;/em&gt; article, &amp;ldquo;Industry braces for New Mexico PFAS product labelling requirements.&amp;rdquo;</description><pubDate>Tue, 19 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Judah Prero, Arnold &amp;amp; Porter Environmental counsel and former Assistant State Attorney General at the Maryland Department of the Environment, was quoted in the&lt;em&gt; Chemical Watch News &amp;amp; Insight&lt;/em&gt; article, &amp;ldquo;Industry braces for New Mexico PFAS product labelling requirements.&amp;rdquo; The article discusses industry reaction to New Mexico&amp;rsquo;s final rule implementing its PFAS restriction law and examines how manufacturers are preparing for the state&amp;rsquo;s new PFAS product reporting and labeling requirements ahead of 2027 compliance deadlines. &lt;/p&gt;
&lt;p&gt;Judah noted that companies increasingly view PFAS reporting obligations as an unavoidable part of the regulatory landscape, particularly as more states adopt similar frameworks. Referencing existing requirements in Minnesota, he explained that while companies are becoming accustomed to PFAS reporting, implementation has proven challenging in practice due to evolving filing systems and delayed deadlines. &lt;/p&gt;
&lt;p&gt;Judah also emphasized that manufacturers are closely watching whether New Mexico aligns its reporting framework with existing state programs to minimize duplicative compliance burdens. He observed that industry is hoping states adopt consistent reporting standards so companies can leverage the same data submissions across multiple jurisdictions.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{743A25BD-1278-43B6-A1DA-FB7D551F2318}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/jonathan-martel-discusses-epa-guidance-on-aftermarket-diesel-sensor-removal-with-inside-epa</link><title>Jonathan Martel Discusses EPA Guidance on Aftermarket Diesel Sensor Removal with Inside EPA</title><description>Jonathan Martel, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Environmental practice group and a former attorney at the U.S. Environmental Protection Agency&amp;rsquo;s (EPA) Office of General Counsel, was quoted in the &lt;em&gt;Inside EPA&lt;/em&gt; article &amp;ldquo;DOJ, EPA Appear Split Over Legality Of Aftermarket Diesel Sensor Removal,&amp;rdquo; which examines questions surrounding EPA guidance on diesel exhaust fluid (DEF) sensor removal and the government&amp;rsquo;s ongoing enforcement posture in aftermarket diesel tampering cases.&amp;nbsp;</description><pubDate>Tue, 19 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Jonathan Martel, co-chair of Arnold &amp;amp; Porter&amp;rsquo;s Environmental practice group and a former attorney at the U.S. Environmental Protection Agency&amp;rsquo;s (EPA) Office of General Counsel, was quoted in the &lt;em&gt;Inside EPA&lt;/em&gt; article &amp;ldquo;DOJ, EPA Appear Split Over Legality Of Aftermarket Diesel Sensor Removal,&amp;rdquo; which examines questions surrounding EPA guidance on diesel exhaust fluid (DEF) sensor removal and the government&amp;rsquo;s ongoing enforcement posture in aftermarket diesel tampering cases. &lt;/p&gt;
&lt;p&gt;Jonathan disagreed that EPA and DOJ are &amp;ldquo;split&amp;rdquo; on the issue, but noted that EPA&amp;rsquo;s recent public statements have created &amp;ldquo;mixed messages&amp;rdquo; regarding the agency&amp;rsquo;s position. He added that EPA&amp;rsquo;s guidance is intended to encourage manufacturers to transition from direct DEF quality sensors to alternative NOx-based monitoring systems, rather than abandoning emissions controls altogether. &lt;/p&gt;
&lt;p&gt;He also observed that aftermarket software replacing DEF sensors with effective NOx-based monitoring systems &amp;ldquo;would likely have a good defense to a tampering allegation,&amp;rdquo; while cautioning that EPA&amp;rsquo;s messaging may have contributed to confusion about the scope of permissible modifications.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://insideepa.com/daily-news/doj-epa-appear-split-over-legality-aftermarket-diesel-sensor-removal?0=ip_login_no_cache%3D0b31b6ae46ce4f8882e9cbe4a534bcc8" target="_blank"&gt;Read the full article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{2C589747-8522-4176-A43D-57AA1D39679B}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/claire-reade-discusses-us-china-trade-dynamics-and-trump-xi-summit-with-bbc-and-al-jazeera</link><title>Claire Reade Discusses U.S.-China Trade Dynamics and Trump-Xi Summit with BBC and Al Jazeera</title><description>Claire Reade, Arnold &amp;amp; Porter senior counsel and former Assistant U.S. Trade Representative for China Affairs, recently spoke with &lt;em&gt;BBC&lt;/em&gt; and &lt;em&gt;Al Jazeera&lt;/em&gt; to discuss the realistic prospects for U.S.-China trade negotiations ahead of the Trump-Xi summit.</description><pubDate>Mon, 18 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Claire Reade, Arnold &amp;amp; Porter senior counsel and former Assistant U.S. Trade Representative for China Affairs, recently spoke with &lt;em&gt;BBC&lt;/em&gt; and &lt;em&gt;Al Jazeera&lt;/em&gt; to discuss the realistic prospects for U.S.-China trade negotiations ahead of the Trump-Xi summit.&lt;/p&gt;
&lt;p&gt;Appearing on the &lt;em&gt;BBC&lt;/em&gt;, Claire noted that China is unlikely to make major concessions or alter the status quo. &amp;ldquo;China is working very hard to ensure that it becomes independent of other countries, including the United States, in its development,&amp;rdquo; she said. Meanwhile, Trump would benefit from positive press if he could negotiate additional trade openings with China, according to Claire.&lt;/p&gt;
&lt;p&gt;Speaking to &lt;em&gt;Al Jazeera&lt;/em&gt;, Claire emphasized the broader strategic tensions shaping the relationship, noting that &amp;ldquo;China does not trust the U.S.&amp;rdquo; and views the relationship through the lens of &amp;ldquo;long-term global competition,&amp;rdquo; dynamics she said significantly constrain the scope of any potential agreement.&lt;/p&gt;
&lt;p&gt;In discussing possible outcomes of the summit, Claire suggested that China may ease restrictions on certain U.S. imports or purchase additional American goods, rather than pursue substantive structural reforms. She further explained that China would only ease restrictions on U.S. technology imports if doing so did not &amp;ldquo;interfere with China&amp;rsquo;s strategic plans to eliminate dependence on U.S. technology over the longer term.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://vimeo.com/1193305322/e244e94bba?share=copy&amp;amp;fl=sv&amp;amp;fe=ci" target="_blank"&gt;Watch the full&lt;em&gt; BBC&lt;/em&gt; interview&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.aljazeera.com/amp/economy/2026/5/15/after-trumps-pledge-to-open-up-china-low-expectations-for-summit-deal" target="_blank"&gt;Read the full &lt;em&gt;Al Jazeera&lt;/em&gt; article&lt;/a&gt;.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{EFA35525-73FE-41CB-8D6A-008F06F83C70}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/president-trump-signs-executive-order-mandating-fixed-price-contracting-in-federal-procurement</link><a10:author><a10:name>Kristen E. Ittig</a10:name><a10:uri>https://www.arnoldporter.com/en/people/i/ittig-kristen-e</a10:uri><a10:email>kristen.ittig@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Amanda J. Sherwood</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sherwood-amanda</a10:uri><a10:email>amanda.sherwood@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Adrienne K. Jackson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jackson-adrienne-k</a10:uri><a10:email>adrienne.jackson@arnoldporter.com</a10:email></a10:author><title>President Trump Signs Executive Order Mandating Fixed-Price Contracting in Federal Procurement</title><description>On April 30, 2026, President Trump signed an Executive Order (EO) titled &amp;ldquo;Promoting Efficiency, Accountability, and Performance in Federal Contracting,&amp;rdquo; directing executive branch agencies to make fixed-price contracts the default and preferred method of federal procurement. But the EO not only establishes a priority for fixed-price contracts; it mandates renegotiation of the 10 largest existing cost-type contracts at each agency within 90 days. This advisory covers the EO&amp;rsquo;s key terms and likely impacts, highlighting what remains to be seen regarding the impacts on federal contractors.</description><pubDate>Mon, 18 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;h2&gt;Overview&lt;/h2&gt;
&lt;p&gt;On April 30, 2026, President Trump signed an &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/presidential-actions/2026/04/promoting-efficiency-accountability-and-performance-in-federal-contracting/" target="_blank"&gt;Executive Order&lt;/a&gt; (EO) titled &amp;ldquo;Promoting Efficiency, Accountability, and Performance in Federal Contracting,&amp;rdquo; directing executive branch agencies to make fixed-price contracts the default and preferred method of federal procurement. But the EO not only establishes a priority for fixed-price contracts; it mandates renegotiation of the 10 largest existing cost-type contracts at each agency within 90 days. This advisory covers the EO&amp;rsquo;s key terms and likely impacts, highlighting what remains to be seen regarding the impacts on federal contractors.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;Federal procurement is accomplished through a spectrum of contract types falling along a risk-allocation continuum:  whereas fixed-price contracts place performance risk primarily on the contractor by requiring delivery of defined outcomes for a set price, cost-reimbursement contracts shift financial risk to the government by guaranteeing recovery of contractors&amp;rsquo; allowable incurred costs plus a profit fee. In recognition of these different risk structures, the Federal Acquisition Regulation (FAR) requires the contracting officer, when selecting and negotiating contract type, to &amp;ldquo;consider contract terms, risks (e.g., technical, performance, delivery), and pricing.&amp;rdquo;  FAR 16.102.[[N: When describing the FAR throughout, this advisory refers to the Revolutionary FAR Overhaul (RFO).&amp;nbsp; Previously, FAR 16.101 required agencies to consider &amp;ldquo;the degree and timing of the responsibility assumed by the contractor for the costs of performance&amp;rdquo; and &amp;ldquo;the amount and nature of the profit incentive offered to the contractor for achieving or exceeding specified standards or goals&amp;rdquo; in selecting a fixed price or cost reimbursement contract type. The RFO simplifies this provision to the quoted text.]]&lt;/p&gt;
&lt;p&gt;The EO describes cost-reimbursement contracting as a source of &amp;ldquo;unpredictable costs, bloated overhead, and weak performance incentives,&amp;rdquo; and states that a review of FY24 spending identified approximately $120 billion obligated on cost-reimbursement consulting contracts alone. Against that backdrop, the EO positions fixed-price contracting &amp;mdash; with its emphasis on clearly defined outcomes, predictable timelines, and profit tied to performance &amp;mdash; as the preferred model for driving contractor accountability and budget discipline.&lt;/p&gt;
&lt;h2&gt;Key Provisions of the Executive Order&lt;/h2&gt;
&lt;h3&gt;1. Fixed-Price Contracting as the Mandatory Default (Section 2(a))&lt;/h3&gt;
&lt;p&gt;The EO requires all federal agencies to utilize fixed-price contracts as the default contract type for future procurements. This obligation applies whether an agency is contracting on its own behalf or on behalf of another agency, including in interagency acquisition arrangements.&lt;/p&gt;
&lt;h3&gt;2. Written Justification and Approval Thresholds for Non-Fixed-Price Contracts (Section 2(b))&lt;/h3&gt;
&lt;p&gt;The EO requires that any use of a non-fixed-price contract &amp;mdash; including cost-reimbursement, time and materials (T&amp;amp;M), labor-hour, or any other non-fixed price contract &amp;mdash; must be justified in writing by the contracting officer. Where the value of a non-fixed-price contract (or the non-fixed-price portion of a hybrid contract) exceeds specified thresholds, written agency head approval is required before award:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Department of Defense): $100 million&lt;/li&gt;
    &lt;li&gt;The National Aeronautics and Space Administration: $35 million&lt;/li&gt;
    &lt;li&gt;Department of Homeland Security: $25 million&lt;/li&gt;
    &lt;li&gt;All other agencies: $10 million&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Agency heads may delegate this approval authority to non-career employees within the agency. The approval requirements do not apply to: (i) contracts supporting responses to emergencies, major disasters, or contingency operations (as defined in FAR Part 2); or (ii) contracts for research and development or pre-production development for major systems acquisition (governed by FAR Parts 34-35). The EO acknowledges that cost-reimbursement contracting remains appropriate in those limited contexts, but directs that it should be the exception rather than the rule.&lt;/p&gt;
&lt;h3&gt;3. Renegotiation Mandate for Existing Non-Fixed-Price Contracts (Section 2(c))&lt;/h3&gt;
&lt;p&gt;Within 90 days of the Order (~July 29, 2026), each agency must review its ten largest non-fixed-price contracts by dollar value and, to the maximum extent practicable and consistent with law, seek to modify, restructure, or renegotiate those contracts to incorporate fixed prices and performance-based incentives. The same exemptions for R&amp;amp;D/major systems and emergency contracts apply. Agencies contracting on behalf of other agencies must include contracts held in that capacity when compiling their list.&lt;/p&gt;
&lt;h3&gt;4. Semi-Annual Reporting to OMB (Section 2(d))&lt;/h3&gt;
&lt;p&gt;Agency heads must report semi-annually to the Office of Management and Budget (OMB) Director the number, value, and written justifications for all non-fixed-price contracts approved by the agency. The first report is due no later than 90 days from the date of the Order (~July 29, 2026). In addition to detailing approved exceptions, the first report must identify broader opportunities for moving existing non-fixed-price contracts toward fixed-price arrangements.&lt;/p&gt;
&lt;h3&gt;5. FAR Amendments and Training (Section 3)&lt;/h3&gt;
&lt;p&gt;Within 45 days of the Order (~June 14, 2026), the OMB Director must issue implementation guidance to all agencies. Within 120 days of the Order (~August 28, 2026), the Administrator for Federal Procurement Policy must: (i) propose, in coordination with the FAR Council, amendments to the FAR to codify fixed-price contracting as the default federal procurement policy; and (ii) develop, in coordination with Defense Acquisition University and the Federal Acquisition Institute, a training program for contracting and program personnel on the formation, use, negotiation, and management of fixed-price contracts. Pending FAR amendments, agencies are directed to use applicable FAR deviations to the maximum extent practicable.&lt;/p&gt;
&lt;h2&gt;Key Implications and Takeaways for Federal Contractors&lt;/h2&gt;
&lt;h3&gt;A. Immediate Risk of Attempted Contract Renegotiation&lt;/h3&gt;
&lt;p&gt;The EO instructs federal agencies to attempt to renegotiate large, cost-type contracts within 90 days. Of course, such existing contracts remain binding unless modified; the government cannot unilaterally change an existing cost-type contract to fixed-price. Contractors who receive government outreach seeking a renegotiation will have to choose whether to engage with their government customer or seek to enforce the terms of their contracts as-written, and potentially face the risk of a termination or non-renewal should the agency be unwilling to continue on a cost reimbursement basis.&lt;/p&gt;
&lt;p&gt;Recognizing these barriers, the EO requires only that agencies seek to renegotiate &amp;ldquo;to the maximum extent practicable and consistent with law.&amp;rdquo; Contractors have legal and contractual arguments against unilateral modifications (especially of this significance), and agencies generally cannot impose conversion without consent. Nonetheless, the government will have significant leverage over contractors that depend on ongoing program funding, renewals, options, or follow-on awards.&lt;/p&gt;
&lt;h3&gt;B. New Award Strategy Considerations and Shifting Risk &lt;/h3&gt;
&lt;p&gt;The new presumption in favor of fixed price procurements is in tension with past procurement practice, which recognized that cost-type contracts make sense in a variety of procurements. Previously, agencies exercised their discretion to select the contract type that would provide the greatest incentive for efficient and economical performance, given the specific circumstances of each individual procurement. That analysis turns on factors , including the degree of cost uncertainty, the complexity of the requirement, the contractor&amp;rsquo;s ability to estimate costs with reasonable confidence at award, and the administrative burden of contract oversight. Agencies selected firm-fixed-price contracts when the scope was well-defined, performance risk was well-understood, and the contractor could price the work with confidence. In turn, agencies pursued cost-reimbursement arrangements where those conditions did not hold: where the work was technically uncertain, where the government could not define the requirement with sufficient precision, or where requiring contractors to absorb performance risk they could not reasonably quantify would either deter competition or produce artificially inflated bids.&lt;/p&gt;
&lt;p&gt;By mandating fixed-price contracting as the default, the EO places a categorical thumb on the scale for a single contract type regardless of whether the underlying requirement supports it at a time when the government&amp;rsquo;s acquisition workforce, which has seen significant cuts, may be hard-pressed to craft the definitive work statements required for fixed price efforts.  For complex developmental services, emerging technology acquisitions, and requirements that are inherently difficult to scope in advance, the result of the EO's mandate may be either poorly structured fixed-price contracts with inadequately defined deliverables or discouraging qualified contractors from competing at all. &lt;/p&gt;
&lt;p&gt;Practically, the written justification process created by the EO may function as a vehicle for documenting the contract type analysis that contracting officers should already be performing. But the institutional pressure to avoid non-fixed-price contracts risks distorting procurement decisions, pushing agencies toward fixed-price structures on requirements that are not a good fit. And critically, the EO&amp;rsquo;s apparent assumption that fixed-price contracting is inherently a cost-saving measure is not necessarily, or even often, true. Requiring contractors to bid a firm-fixed price on poorly scoped or ambiguous requirements will necessarily lead to inclusion of strategic amounts to cover contingent risks that contractors cannot rule out, with the resulting bids reflecting not the expected cost of performance, but the contractor&amp;rsquo;s best assessment of the amount required to cover its own risk.[[N: The so-called firm-fixed-price risk premium includes the spread between what a contractor would bid under a well-structured cost-reimbursement arrangement (estimated costs plus a negotiated fee) and what it must bid under a fixed-price vehicle to cover the full distribution of cost outcomes, including adverse scenarios. Depending on the nature, duration, and technical complexity of the work, this premium can be substantial.]] A well-administered cost-reimbursement contract on such ambiguous or undefined requirements could therefore actually cost the government less, something the EO seems to ignore. Forcing ill-defined requirements to be bid as firm-fixed price may also serve as a barrier to competition, particularly for small businesses, which may be unable to accept the large potential downside risks of fixed price contracting vehicles.&lt;/p&gt;
&lt;h3&gt;C. Impact on Contractor Proposal Development&lt;/h3&gt;
&lt;p&gt;Any broad shift from issuing solicitations on a cost basis to fixed-price requirements will necessarily result in contractors assuming greater risk, which merits additional contractor diligence during the bid and proposal development process. Bid and proposal teams should evaluate whether the scope of work is sufficiently well-defined to support firm-fixed-price pricing, whether performance-based incentive structures are achievable, and how to price risk appropriately. Engage with the procuring agency actively to question any ambiguities in contract scope, and craft proposals to cabin risk where possible. Underpricing risk in a rush to win work on a fixed-price vehicle carries material financial consequences that can be difficult to recover.&lt;/p&gt;
&lt;p&gt;By corollary, the government may find that the EO results in contractors , including a premium corresponding to this increased risk in their prices &amp;mdash; ironically causing bids to go up, contrary to the EO&amp;rsquo;s apparent intention. This means that the government's intended savings from eliminating cost overruns on a cost-type contract may simply be replaced by higher base prices on the fixed-price vehicle &amp;mdash; with the additional disadvantage that the fixed price provides no mechanism for the government to benefit if actual costs come in below the contract price.&lt;/p&gt;
&lt;h3&gt;D. A Future Surge in REAs?&lt;/h3&gt;
&lt;p&gt;Another potential result of the EO could very well be a delayed reckoning with the true scope and costs of a procurement in the form of requests for equitable adjustment (REAs) and contract disputes. Fixed-price contracts contain a Changes clause (FAR 52.243-1) that entitles a contractor to an equitable adjustment when the government orders a change within the general scope of the contract. This, however, turns on whether the government has adequately defined and cabined the scope of work at the time of award. Where the scope is well-defined, the Changes clause operates as intended: discrete, government-directed changes give rise to discrete, quantifiable adjustments. Where the scope is poorly defined, and the boundaries of the original contract are contested from the outset, disputes will inevitably arise over whether work is included in the original scope or is a &amp;ldquo;change.&amp;rdquo;&lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The EO has broad ambitions, but how much it will change procurement in practice remains to be seen. Fixed-price contracting is already the norm for well-defined requirements, and agencies remain able to justify cost-type vehicles when the work genuinely warrants them. The renegotiation mandate may be a more immediate and concrete consequence: contractors holding large cost-reimbursement, T&amp;amp;M, or labor-hour contracts should prepare strategies should they receive agency outreach in the near term.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter's Government Contracts practice is available to assist clients in assessing their exposure and navigating renegotiation discussions. If you have questions about this Advisory, please contact a member of our Government Contracts Practice Group or your existing Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F0E4B4BE-55F4-4F1C-A615-00989F653AD4}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/agri-stats-settlement</link><a10:author><a10:name>Robert J. Katerberg</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/katerberg-robert-j</a10:uri><a10:email>robert.katerberg@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Javier Ortega Alvarez</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/ortega-alvarez-javier</a10:uri><a10:email>javier.ortega@arnoldporter.com</a10:email></a10:author><title>Crying Fowl: What the Agri Stats Settlement Means for Competitor Benchmarking Programs</title><description>On May 7, 2026, the DOJ and several states reached a proposed settlement with Agri Stats, alleging that its meat industry benchmarking reports facilitated unlawful information sharing among competitors and enabled price coordination. The settlement imposes detailed restrictions on how competitively sensitive data may be collected, aggregated, aged, and distributed, reflecting the DOJ&amp;rsquo;s clearest guidance to date on the limits of permissible benchmarking and signaling a more aggressive enforcement approach toward industry information exchanges.</description><pubDate>Mon, 18 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On May 7, 2026, the Antitrust Division of the U.S. Department of Justice (DOJ), along with several states, reached a settlement (&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1439906/dl?inline" target="_blank"&gt;Proposed Settlement&lt;/a&gt;) with Agri Stats, Inc., to resolve allegations that Agri Stats&amp;rsquo; meat industry reports amounted to an impermissible exchange of information among competitors aimed at facilitating price fixing. Agri Stats is a data-sharing and consulting company engaged in the collection of prices, output, and costs from growers and processors in the broiler chickens, turkeys, and pork industries. The Proposed Settlement follows prior settlements between private plaintiffs and Agri Stats in related lawsuits alleging price-fixing of broiler chickens and turkeys.[[N:Uncontested Motion For Preliminary Approval of Settlement, &lt;em&gt;In re Broiler Chicken Antitrust Litigation&lt;/em&gt;, No. 1:16-cv-08637 (N.D. Ill. Mar. 31, 2026); Unopposed Motion For Preliminary Approval of Settlement, &lt;em&gt;In re Turkey Antitrust Litigation&lt;/em&gt;, No. 19-cv-08318 (N.D. Ill. Mar. 31, 2026).]]&lt;/p&gt;
&lt;p&gt;The Proposed Settlement imposes a number of conduct restrictions on what data Agri Stats may collect and report, how that data must be aggregated and aged before it can be shared, who may purchase its reports and on what terms, and how compliance with all of these obligations will be monitored and enforced going forward. Taken together, these commitments represent the DOJ&amp;rsquo;s most detailed articulation to date of the boundaries between permissible benchmarking and unlawful information sharing among competitors, and carry significant implications for companies across industries who participate in or operate similar data-sharing arrangements.&lt;/p&gt;
&lt;h2&gt;Information Exchange Safe Harbors Withdrawal and Subsequent Guidance &lt;/h2&gt;
&lt;p&gt;As we previously wrote about,[[N:&lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2023/02/no-safe-harbors-doj-signals-increased-scrutiny" target="_self"&gt;No Safe Harbors: DOJ Signals Increased Scrutiny of Information Exchanges&lt;/a&gt;.]] in February 2023, DOJ and the Federal Trade Commission (FTC) withdrew two guidance documents that had provided a set of safe harbors to industry, including a safe harbor for competitor information exchange programs (collectively, the &amp;ldquo;Safe Harbor Guidelines&amp;rdquo;).[[N:Press Release, Dep&amp;rsquo;t of Justice, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-withdraws-outdated-enforcement-policy-statements" target="_blank"&gt;Justice Department Withdraws Outdated Enforcement Policy Statements&lt;/a&gt;.]] According to then-Principal Deputy Assistant Attorney General Doha Mekki, who had previewed the withdrawal during a speech, the Safe Harbor Guidelines were &amp;ldquo;outdated&amp;rdquo; and &amp;ldquo;no longer reflected market realities.&amp;rdquo;[[N:&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/speech/principal-deputy-assistant-attorney-general-doha-mekki-antitrust-division-delivers-0#_ftnref12" target="_blank"&gt;Prepared Remarks of Principal Deputy Assistant Attorney General Doha Mekki of the Antitrust Division at GCR Live: Law Leaders Global 2023&lt;/a&gt; (Feb. 2, 2023) (Mekki Remarks).]] &lt;/p&gt;
&lt;p&gt;The withdrawn Safe Harbor Guidelines had offered industry a set of conditions that if followed would tend to reduce antitrust risk when sharing competitively sensitive information: (1) the survey must be managed by a third party; (2) the information provided is relatively old; (3) the information is aggregated to protect the identity of the underlying sources; and (4) a sufficient number of sources are aggregated to prevent competitors from linking particular data to an individual source. Although the withdrawn guidance was addressed specifically to healthcare industry participants, the guidance was often applied by enforcers and courts to information exchanges more broadly and provided companies in any sector a set of readily-identifiable and clear conditions to follow when exchanging information. &lt;/p&gt;
&lt;p&gt;Over the proceeding years since the withdrawal of the Safe Harbor Guidelines, the DOJ filed a series of statements of interest in antitrust cases across multiple industries, each giving insight into the legal framework that ultimately underpins the Proposed Settlement&amp;rsquo;s specific prohibitions and requirements. For example, DOJ filed a statement of interest in a private litigation related to information sharing and benchmarking among pork producers and Agri Stats, arguing that aggregating data in and of itself does not provide a safe harbor from liability.[[N:&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1371806/dl" target="_blank"&gt;Statement of Interest&lt;/a&gt;, &lt;em&gt;In re Pork Antitrust Litigation&lt;/em&gt;, No. 0:18-cv-01776-JRT-JFD (D. Minn. Oct. 1, 2024).]] DOJ also filed a statement of interest in a private litigation related to information sharing and benchmarking among frozen potato product producers, arguing that the central question courts should answer is whether the exchange would tend to suppress competition, even if data is aggregated, anonymized, or backward-looking.[[N:&lt;a rel="noopener noreferrer" href="https://www.justice.gov/atr/media/1429466/dl?inline" target="_blank"&gt;Statement of Interest&lt;/a&gt;, &lt;em&gt;In re Frozen Potato Products Antitrust Litigation&lt;/em&gt;, No. 1:24-cv-11801 (N.D. Ill. Feb. 27, 2026).]]&lt;/p&gt;
&lt;h2&gt;The Agri Stats Proposed Settlement&lt;/h2&gt;
&lt;p&gt;The DOJ, along with the states of California, Minnesota, North Carolina, Tennessee, Texas, and Utah, sued Agri Stats in 2023, alleging that Agri Stats facilitated the exchange of competitively sensitive information, such as price, output, and costs, among meat processing companies. The exchange of information itself is the alleged violation of the Sherman Act, rather than being used as circumstantial evidence of a price-fixing conspiracy. The Proposed Settlement, which is the clearest articulation of what enforcers will consider permissible industry benchmarking among competitors, sets forth a series of commitments and requirements by which Agri Stats must abide to continue reporting information regarding meat processing. Specifically, the Proposed Settlement requires Agri Stats to:[[N:Press Release, &lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/justice-department-requires-agri-stats-end-exchange-competitively-sensitive-information" target="_blank"&gt;Justice Department Requires Agri Stats to End Exchange of Competitively Sensitive Information Among Nation&amp;rsquo;s Largest Meat Processors that Suppressed Competition and Increased Prices for Decades&lt;/a&gt; (May 7, 2026).]]&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Stop providing any sales reports or non-public pricing information available only to producers&lt;/strong&gt;. According to DOJ, meat processors had systematically used these data to identify opportunities to increase prices. The Proposed Settlement, however, expressly carves out and allows continued price reports by Express Markets Inc., a subsidiary of Agri Stats. DOJ stated in its press release that Express Markets&amp;rsquo; reports did not raise the same concerns because that pricing information was less detailed and available to all interested parties, not just meat processors.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Stop reporting production, cost, and labor data at either the company or facility level&lt;/strong&gt;. According to DOJ, access to competitors&amp;rsquo; data at this granular level had allowed meat processors to adjust pricing and output.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Make information that Agri Stats distributes available to all interested domestic purchasers on reasonable and non-discriminatory terms&lt;/strong&gt;. According to DOJ, this will eliminate information asymmetry and increase market transparency.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Adhere to restrictions on the timeliness of the information that Agri Stats shares&lt;/strong&gt;. According to DOJ, the availability of near-current data allowed competing meat processors to better understand market dynamics, facilitating collusion in almost real time. The Proposed Settlement generally requires that reported information be based on data that is at least 45 days old on average, and at least 90 days old for certain data related to production decisions.&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Comply with certain metrics to ensure that reported data is not dominated by one or a few participants&lt;/strong&gt;. The Proposed Settlement generally requires that no single contributor account for more than 70% of the data reflected in a report, and that each reported statistic contain data from at least three contributors.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The Proposed Settlement also requires the appointment of a Monitor to oversee Agri Stats&amp;rsquo; compliance with the settlement, requires Agri Stats to establish an antitrust compliance program, and gives DOJ and the plaintiff states the right to inspect Agri Stats&amp;rsquo; records to ensure compliance with the settlement. &lt;/p&gt;
&lt;h2&gt;Looking Ahead&lt;/h2&gt;
&lt;p&gt;Companies involved in benchmarking and other information exchange programs, both those that contribute data and those that receive reports, will benefit from carefully considering how data is collected and reported within their relevant market to avoid being involved in conduct that may be considered to harm competition. Notably, the prohibitions and requirements outlined in the Proposed Settlement are stricter than the withdrawn Safe Harbor Guidelines in some ways, but more permissive in others. For example, the Proposed Settlement allows certain reported information to be based on data that is only 45 days old and from only three contributors, as opposed to the 90-day and minimum of five contributors requirements in the Safe Harbor Guidelines. &lt;/p&gt;
&lt;p&gt;Companies will need to take into consideration conditions and dynamics of the specific market when assessing the risk posed by participating in information exchange programs. But the Proposed Settlement offers three general takeaways: (1) aggregated and anonymized data does not in itself create a presumption of legality &amp;mdash; instead, reported data must be formatted in a way that does not allow recipients to infer the identity of contributors; (2) limiting reports to purely historical data is still advisable, but what qualifies as historical may vary based on specific market conditions; and (3) sellers and buyers must both be given unconditioned access to reports to avoid market asymmetry.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{001F66AA-E992-447C-B84C-B102238F533C}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/05/arnold-porter-at-the-accountants-liability-2026-conference</link><a10:author><a10:name>Veronica E. Callahan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/callahan-veronica-rendn</a10:uri><a10:email>veronica.callahan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Adrien K. Anderson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/anderson-adrien-k</a10:uri><a10:email>adrien.anderson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eun Young Choi</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/choi-eun-young</a10:uri><a10:email>EunYoung.Choi@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kathleen Reilly</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/reilly-kathleen</a10:uri><a10:email>kathleen.reilly@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>David B. Schwartz</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/schwartz-david-b</a10:uri><a10:email>david.schwartz@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Stephanna F. Szotkowski</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/szotkowski-stephanna</a10:uri><a10:email>stephanna.szotkowski@arnoldporter.com</a10:email></a10:author><title>Arnold &amp; Porter at the Accountants’ Liability 2026 Conference</title><description>Arnold &amp;amp; Porter is co-chairing the annual Accountants&amp;rsquo; Liability Conference, the premier CLE event for the profession, bringing together SEC and PCAOB leadership, Big Four and mid-market accounting firms, and outside counsel to discuss enforcement trends, audit litigation, and emerging issues.</description><pubDate>Thu, 14 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter&amp;rsquo;s Securities Enforcement &amp;amp; Litigation practice is co-chairing the annual &lt;a rel="noopener noreferrer" href="https://cle.ali.org/catalog/product.xhtml?eid=71310" target="_blank"&gt;Accountants&amp;rsquo; Liability Conference&lt;/a&gt;, the premier CLE event for the profession, bringing together SEC and PCAOB leadership, Big Four and mid-market accounting firms, and in-house counsel to discuss enforcement trends, audit litigation, and emerging issues. Veronica Callahan will serve as co-chair, and includes our &lt;em&gt;Chambers&lt;/em&gt;-ranked auditor and accountants&amp;rsquo; liability team alongside a cross-practice group of attorneys from our privacy, cybersecurity, white collar, and digital assets and cryptocurrency groups, reflecting the increasingly multidisciplinary nature of the risks facing the accounting profession today.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter Speakers:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Veronica Callahan&lt;/strong&gt;&amp;nbsp;&amp;mdash; Conference Co-Chair; Moderator, &amp;ldquo;Global and Domestic Events and Their Impact on the Accounting Profession&amp;rdquo;; Moderator, Keynote Fireside Chat with PCAOB leadership&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Adrien Anderson&lt;/strong&gt; &amp;mdash;&amp;nbsp;Moderator, &amp;ldquo;Crypto and Predictions Markets&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Eun Young Choi&lt;/strong&gt; &amp;mdash;&amp;nbsp;Panelist, &amp;ldquo;Crypto and Predictions Markets&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Kathleen Reilly&lt;/strong&gt; &amp;mdash;&amp;nbsp;Moderator, &amp;ldquo;Private Credit and the Accounting Industry&amp;rdquo;; Moderator, &amp;ldquo;PCAOB Inspection Program&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;David Schwartz&lt;/strong&gt; &amp;mdash;&amp;nbsp;Panelist, &amp;ldquo;Data Privacy and Related Issues Challenging the Accounting Profession&amp;rdquo;&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Stephanna Szotkowski&lt;/strong&gt; &amp;mdash;&amp;nbsp;Moderator, &amp;ldquo;AI and the Accounting Profession&amp;rdquo;&lt;/li&gt;
&lt;/ul&gt;</a10:content></item><item><guid isPermaLink="false">{38D42D3D-7E11-4A50-8D06-4CF163280D6D}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/dod-extends-foreign-ownership-control-or-influence-disclosure-requirements</link><a10:author><a10:name>Nancy L. Perkins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/perkins-nancy-l</a10:uri><a10:email>nancy.perkins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Amanda J. Sherwood</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sherwood-amanda</a10:uri><a10:email>amanda.sherwood@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dustin Vesey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vesey-dustin</a10:uri><a10:email>dustin.vesey@arnoldporter.com</a10:email></a10:author><title>DOD Extends Foreign Ownership, Control, or Influence Disclosure Requirements to Unclassified Contracts and Subcontracts Greater Than $5 Million</title><description>&lt;p&gt;On May 6, 2026, the U.S. Department of Defense (DOD) &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/05/07/2026-09067/defense-federal-acquisition-regulation-supplement-mitigating-risks-related-to-foreign-ownership" target="_blank"&gt;published a proposed rule&lt;/a&gt; that would extend the current prohibition on awarding classified contracts to a company subject to foreign ownership, control, or influence (FOCI), absent satisfactory FOCI-mitigation measures, to awards of noncommercial defense contracts valued at $5 million or more, regardless of whether the work requires access to classified information.[[N: Although the proposed rule generally excepts solicitations for commercial DOD contracts, a designated senior DOD official may determine that a commercial contract &amp;ldquo;involves a risk or potential risk to national security because of sensitive data, systems, or processes,&amp;rdquo; and for that reason incorporate the new DFARS clause imposing FOCI restrictions.]] To effectuate this new prohibition, the proposed rule would require all contractors bidding on and performing such defense contracts &amp;mdash; and subcontractors whose subcontracts are valued at $5 million or more &amp;mdash; to submit to the Defense Counterintelligence and Security Agency (DCSA) information regarding any relationships maintained by the contractor with foreign persons, which DOD may use in its evaluation of bids submitted to competitive procurements. &lt;/p&gt;
&lt;p&gt;Companies interested in working with the DOD should carefully review the proposed rule and consider what the proposed disclosure obligations mean for their business.&lt;/p&gt;
&lt;h2&gt;Background&lt;/h2&gt;
&lt;p&gt;This proposed rule implements Section 847 of the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA), which instructed the Secretary of Defense to &amp;ldquo;improve the process and procedures for the assessment and mitigation of risks related to foreign ownership, control, or influence (FOCI) of contractors and subcontractors doing business with the Department of Defense.&amp;rdquo; The Joint Explanatory Statement that accompanied the FY20 NDAA explains Section 847&amp;rsquo;s purpose as follows:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;The conferees are concerned by the growing threat to the integrity of the defense industrial base from strategic competitors, like the Russian Federation, the People&amp;rsquo;s Republic of China, and their proxies, seeking to gain access to sensitive defense information or technology through contractors or subcontractors. The conferees recognize that there are existing efforts underway to understand and mitigate some of these risks as directed by several pilot programs &amp;hellip;. However, the acquisition community must have greater visibility into all cleared and uncleared potential contractors and subcontractors seeking to do business with the Department. The Department must ensure that contractors and subcontractors do not pose a risk to the security of sensitive data, systems, or processes such as personally identifiable information, cybersecurity, or national security systems.&lt;/p&gt;
&lt;p&gt;To operationalize the above mandates, Section 847 specifically requires the DOD to promulgate new clauses in the Defense Federal Acquisition Regulation Supplement (DFARS) to extend FOCI disclosure and mitigation requirements to nonclassified, noncommercial defense contracts valued at $5 million or more. (Contractors working on classified contracts are already subject to restrictions on beneficial ownership and FOCI disclosure and mitigation procedures.)&lt;/p&gt;
&lt;h2&gt;Disclosure Requirements&lt;/h2&gt;
&lt;p&gt;Consistent with Congress&amp;rsquo; direction, the proposed rule would establish a new DFARS section 240.27X, Mitigation of Risks Related to Beneficial Ownership or Foreign Ownership, Control, or Influence, that imposes requirements on contractors bidding on DOD applicable contracts, those awarded such contracts, and subcontractors performing similarly valued subcontracts under such contracts.&lt;/p&gt;
&lt;p&gt;First, the rule would require solicitations for noncommercial DOD contracts valued at $5 million or more to require offerors to submit Standard Form 328 (SF-328) &amp;mdash; the Certificate Pertaining to Foreign Interests &amp;mdash; and all required associated documents to DCSA. The SF-328 requires the offeror to report all FOCI that may exist with respect to the company. For example, the SF-328 asks, among other things:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Does any foreign person(s), directly or indirectly, own, beneficially own, or subscribe to 5 percent or more of the outstanding shares of any class of stock, participation interest, units, or total capital commitment for your organization?&lt;/li&gt;
    &lt;li&gt;Do any foreign persons serve as a member of your organization&amp;rsquo;s governing body, or hold a management position?&lt;/li&gt;
    &lt;li&gt;Does your organization have any contracts, agreements, understandings, grants, side letters, or arrangements with a foreign person(s)?&lt;/li&gt;
    &lt;li&gt;During your organization&amp;rsquo;s last fiscal year, did it derive 5 percent or more of its total revenue, net income, tuition, gifts, or endowments from any single foreign person?&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;For any question to which an offeror responds &amp;ldquo;Yes,&amp;rdquo; the offeror must submit additional documentation, as outlined in the SF-328. &lt;/p&gt;
&lt;p&gt;In addition to submitting the SF-328, the proposed rule requires offerors to provide contact information for each &amp;ldquo;beneficial owner&amp;rdquo; of the business in the &lt;a rel="noopener noreferrer" href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.dcsa.mil%2FSystems-Applications%2FNational-Industrial-Security-System-NISS%2F&amp;amp;data=05%7C02%7CShelby.Mitchell%40arnoldporter.com%7Cab68c63495324a54fc6808deb1e7b49b%7Cd22d141fae37447facfa2e1d0e5b4969%7C0%7C0%7C639143805890559517%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;amp;sdata=JGeysX0aIisLJMfTw9s3GkQbmK7yYkJqY29CQDjQeRM%3D&amp;amp;reserved=0" target="_blank"&gt;National Industrial Security System&lt;/a&gt; (NISS). A &amp;ldquo;beneficial owner&amp;rdquo; is any individual or entity who, directly or indirectly, ultimately owns or controls the business. By submitting an offer under solicitations containing this new clause, offerors will represent that they have submitted the SF-328 to DCSA and beneficial owner contact information to NISS and that the information is current, accurate, and complete.&lt;/p&gt;
&lt;p&gt;Second, the disclosure obligation does not end at bid submission &amp;mdash; the proposed DFARS clause also requires contractors to provide updates to their FOCI and beneficial ownership disclosures to DCSA throughout the life of the contract whenever a change to such information occurs. Furthermore, in relation to subcontracts exceeding $5 million, prime contractors must flow down the reporting obligation and ensure the subcontractor is listed as &amp;ldquo;eligible&amp;rdquo; in the NISS prior to award and for the duration of performance. If a change renders the subcontractor subject to FOCI during contract performance, the contractor is responsible for ensuring that the change is reported and any mitigation is effectuated. &lt;/p&gt;
&lt;h2&gt;Impact on Evaluations and Mitigation Requirements&lt;/h2&gt;
&lt;p&gt;Based on information provided in the SF-328 and associated documentation or any update furnished to DCSA, DCSA will determine whether the offeror or contractor is under FOCI by considering whether a &amp;ldquo;foreign interest&amp;rdquo; has the power, directly or indirectly, to:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Direct or decide matters affecting the management or operations of that company in a manner that may result in a risk or potential risk to national security or potential compromise of sensitive data, systems, or processes&lt;/li&gt;
    &lt;li&gt;Otherwise control or influence the business or management of the contractor in a manner that could adversely affect its ability to perform the contract or subcontract&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&amp;ldquo;Foreign interest&amp;rdquo; is defined broadly to include: any foreign government, agency of a foreign government, or representative of a foreign government; any form of business enterprise or legal entity organized, chartered, or incorporated under the laws of another country; and any person who is not a citizen or national of the United States.&lt;/p&gt;
&lt;p&gt;The proposed DFARS clause requires the DOD contracting entity to, before making award and based on input from DCSA, determine whether the offeror &amp;ldquo;poses a risk or potential risk of compromise to national security &amp;hellip; related to FOCI or beneficial ownership,&amp;rdquo; and if so, determine whether such risk may be mitigated. To be eligible for contract award, the offeror must agree at the time of award to implement any risk mitigation strategy prescribed by the DOD contracting entity within 90 days of award. Relatedly, if the DOD&amp;rsquo;s contracting entity determines an already-performing contractor is under FOCI based on an update provided to DCSA, the contractor must similarly implement a risk mitigation strategy within 90 days of DOD identifying the risk. Only by implementing such a mitigation strategy &amp;mdash; or being found to have no FOCI or beneficial ownership risks &amp;mdash; can an offeror receive or maintain &amp;ldquo;eligible&amp;rdquo; status in the NISS. &lt;/p&gt;
&lt;p&gt;A contracting officer may not award, modify, or exercise an option or otherwise extend a contract, task order, or delivery order unless the offeror or contractor has an &amp;ldquo;eligible&amp;rdquo; status in NISS. Neither may a prime contractor award or maintain a subcontract in excess of $5 million without ensuring the subcontractor maintains &amp;ldquo;eligible&amp;rdquo; status in NISS. &lt;/p&gt;
&lt;h2&gt;Conclusion&lt;/h2&gt;
&lt;p&gt;The proposed rule&amp;rsquo;s expansion of beneficial ownership and FOCI information disclosure and mitigation requirements are designed to protect sensitive DOD information from foreign influence. By requiring detailed assessments of beneficial ownership information to detect FOCI early in the contracting process, DOD will be better equipped to establish mitigation measures that help reduce the risk of foreign adversaries gaining access to sensitive defense-related information and intellectual property. But these changes also have broad implications for federal defense contractors.&lt;/p&gt;
&lt;p&gt;First, defense contractors that have not already been subject to DCSA&amp;rsquo;s FOCI screening for classified contracts should prepare and have ready for disclosure detailed information about their beneficial ownership and foreign operations. Second, mitigation strategies will not be optional when they are required by DOD. Offerors and contractors must be prepared to work with the DOD contracting entity to mitigate the risk of FOCI or risk losing contracts (and even subcontracts). Third, obligations will not end upon submission of an offer. Contractors will need to stay vigilant throughout the life of a contract, keep DOD informed of pertinent changes to beneficial ownership and FOCI information, and monitor compliance of their subcontractors. Fourth, defense contractors may reasonably conclude that a high risk of FOCI may reduce their competitiveness for future contracts with DOD (even in the commercial sphere). As such, companies may wish to consider the potential follow-on effects of any future foreign ventures or partnerships.&lt;/p&gt;
&lt;p&gt;Comments on the proposed rule are due on or before July 6, 2026. Please contact any author of this Advisory or your Arnold &amp;amp; Porter relationship attorney if you would like to submit comments, have questions about the proposed rule, or to seek further guidance or advice.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</description><pubDate>Thu, 14 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{DD1B4AC2-6035-4F4F-8F86-314E849B2AFA}</guid><link>https://www.biosliceblog.com/2026/05/mhra-launches-consultation-on-modernising-the-definition-of-gene-therapy-medicinal-products/</link><a10:author><a10:name>Libby Amos-Stone</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/amos-libby</a10:uri><a10:email>libby.amos-stone@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><title>MHRA Launches Consultation on Modernising the Definition of Gene Therapy Medicinal Products</title><pubDate>Thu, 14 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{F4FA4A10-8BEE-4603-8F61-09D3D55D5C8F}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/05/10-months-later-updates-on-us-stablecoin-law</link><author>kevin.toomey@arnoldporter.com</author><title>10 Months Later: Updates on U.S. Stablecoin Law</title><description>Panelists Justin Skidmore and Kevin Toomey will look back at the first 10 months of the GENIUS Act in the U.S., covering obligations across reserves, disclosures, certifications, licensing, and AML.</description><pubDate>Wed, 13 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;In the conference&amp;rsquo;s opening session, Kevin Toomey (Partner, Chair of Financial Services, Arnold &amp;amp; Porter) and his co-panelist Justin Skidmore (Associate General Counsel, Paxos) will look back at the first 10 months of the GENIUS Act in the U.S., covering obligations across reserves, disclosures, certifications, licensing, and AML. Further conference details here:&amp;nbsp;&lt;a rel="noopener noreferrer" href="https://www.americanconference.com/payment-stablecoins-law-licensing-compliance/agenda/" target="_blank"&gt;Agenda | Payment Stablecoins: Law, Licensing &amp;amp; Compliance&lt;/a&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{253B27F3-0752-4CB2-AD79-FD2CBCA39BB0}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/us-chamber-of-commerce-and-brazilian-national-confederation</link><title>U.S. Chamber of Commerce and Brazilian National Confederation of Industry Recognize Ambassador Thomas A. Shannon, Jr. with Brazil–U.S. Industry Award</title><description>Arnold &amp;amp; Porter Senior International Policy Advisor and Global Law &amp;amp; Public Policy Practice Co-Chair Ambassador Tom Shannon received the inaugural Brazil&amp;ndash;U.S. Industry Award in the Institutional Diplomacy category.&amp;nbsp;</description><pubDate>Wed, 13 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Senior International Policy Advisor and Global Law &amp;amp; Public Policy Practice Co-Chair Ambassador Tom Shannon received the inaugural Brazil&amp;ndash;U.S. Industry Award in the Institutional Diplomacy category. Presented jointly by the U.S. Chamber of Commerce and the Brazilian National Confederation of Industry (CNI), the award recognizes his outstanding leadership and enduring commitment to strengthening the bilateral relationship between the United States and Brazil.&lt;/p&gt;
&lt;p&gt;The first edition of the Brazil&amp;ndash;United States Industry Awards recognized Brazilian and U.S. leaders and institutions that contribute to strengthening the economic relationship between the two countries, with emphasis on actions related to productive integration, innovation, industrial transformation, and institutional cooperation. Honorees were recognized across three categories: Brazil&amp;ndash;United States Economic Integration, Innovation and Industrial Transformation, and Institutional Diplomacy.&lt;/p&gt;
&lt;p&gt;Ambassador Shannon brings to Arnold &amp;amp; Porter more than 35 years of diplomatic experience, during which he became one of the most influential figures in shaping the strategic partnership between Brazil and the United States. He served in Bras&amp;iacute;lia as Special Assistant and later as U.S. Ambassador to Brazil from 2010 to 2013, and held senior positions at the State Department and the National Security Council, where he played a central role in expanding cooperation in security, trade, investment, and academic exchange between the two nations. At Arnold &amp;amp; Porter, he continues to advance the bilateral relationship as a cornerstone of 21st-century prosperity.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{4B03054E-73FB-497C-93AA-E2D0687083FC}</guid><link>https://claandrise.swoogo.com/2026CLARISERegConference</link><author>camille.heyboer@arnoldporter.com</author><title>Panel with former U.S. Environmental Protection Agency Office of General Counsel Attorneys</title><pubDate>Wed, 13 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{E4FE4347-5E60-455F-8F4B-7831F3021143}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/david-kerschner-and-rachel-forman-talk-digital-product-liability-with-law360</link><title>David Kerschner and Rachel Forman Talk Digital Product Liability with Law360</title><description>Arnold &amp;amp; Porter Product Liability Litigation partner David Kerschner and counsel Rachel Forman were quoted in the recent &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;What To Watch For As Meta Stares Down NM Injunction Trial,&amp;rdquo; discussing the product liability implications of &lt;em&gt;New Mexico v. Meta Platforms Inc. et al.&lt;/em&gt; as the second-phase proceedings begin.</description><pubDate>Tue, 12 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter Product Liability Litigation partner David Kerschner and counsel Rachel Forman were quoted in the recent &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;What To Watch For As Meta Stares Down NM Injunction Trial,&amp;rdquo; discussing the product liability implications of &lt;em&gt;New Mexico v. Meta Platforms Inc. et al.&lt;/em&gt; as the second-phase proceedings begin.&lt;/p&gt;
&lt;p&gt;David highlighted that, regardless of success on appeal, any decision awarding injunctive relief may encourage plaintiffs to bring more lawsuits.&lt;/p&gt;
&amp;ldquo;You could see in the future plaintiffs&amp;rsquo; lawyers in more traditional product liability cases using that as kind of a marker on ways that they think companies should be acting,&amp;rdquo; he said.
&lt;p&gt;Rachel also noted that there&amp;rsquo;s an ongoing debate over whether nuisance claims are the right avenue for addressing product liability claims.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;This is not a traditional product case where plaintiffs are proving a specific design defect; they just have to show in this case that the design change is necessary to get the relief and abate the public harm,&amp;rdquo; she said.&lt;/p&gt;
&lt;p&gt;She added that ordering Meta to make broad changes would likely have implications for non-public nuisance product liability cases, with &amp;ldquo;the potential to dictate what design features digital platforms have.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2472811/what-to-watch-for-as-meta-stares-down-nm-injunction-trial" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{9157B6BA-F0CA-4E59-8F95-6A2CADA62464}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/arnold-porter-secures-complete-victory-for-nrco-in-lng-project-arbitration</link><title>Arnold &amp; Porter Secures Complete Victory for NRCO in LNG Project Arbitration</title><description>Arnold &amp;amp; Porter secured a complete victory for NRCO Engineering, S.A. in an ICDR arbitration in Houston arising from a cross-border liquefied natural gas (LNG) supply venture in Eastern Europe.</description><pubDate>Tue, 12 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter secured a complete victory for NRCO Engineering, S.A. in an ICDR arbitration in Houston arising from a cross-border liquefied natural gas (LNG) supply venture in Eastern Europe. NRCO is owned by Ovik Mkrtchyan, an engineer and businessman from Uzbekistan who founded Gor Investment Limited, a global enterprise focused on advancing sustainable, innovative technologies. The tribunal found a Texas energy company and its president liable for breach of contract and ordered them to pay all damages, attorneys&amp;rsquo; fees, and interest that NRCO requested.&lt;/p&gt;
&lt;p&gt;The dispute arose from an LNG project to supply natural gas to Bulgaria. The underlying transaction involved multiple energy-infrastructure components, including potential supply strategies through Poland and Lithuania, equity participation in an energy company, project development obligations, and a performance security bond connected to a European gas pipeline. Following a five-day final hearing, the tribunal awarded NRCO the complete relief it sought. The tribunal also rejected the Respondents&amp;rsquo; equitable and other defenses, finding that the president of the Texas energy company had spread false and disparaging information about Mr. Mkrtchyan that caused harm to him and his family in Uzbekistan.&lt;/p&gt;
&lt;p&gt;The arbitration team was led by litigation partner Ryan Hartman, who is co-chair of the firm&amp;rsquo;s Energy and Infrastructure group, with Sally Pei and Volodymyr Ponomarov, in close collaboration with John Bellinger, who leads the firm&amp;rsquo;s Global Law and Public Policy practice. The victory adds to Arnold &amp;amp; Porter&amp;rsquo;s deep experience representing clients in complex energy, infrastructure, and cross-border disputes.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{E742E53D-0A0A-4BF9-8236-7F152117324D}</guid><link>https://www.linkedin.com/feed/update/urn:li:activity:7460675803694034945/</link><author>Bart.Wasiak@arnoldporter.com</author><title>The Rise of the AI Arbitrator: Technology, Trust, and the Future of International Arbitration</title><pubDate>Tue, 12 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{2C1AC752-106C-4A47-859B-8F0511F38725}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/05/judge-joseph-greenaway-jr-shares-appellate-tips-and-insights-in-law360</link><title>Judge Joseph Greenaway Jr. Shares Appellate Tips and Insights in Law360</title><description>Judge Joseph A. Greenaway Jr., Arnold &amp;amp; Porter partner who formerly served as a judge on both the U.S. Court of Appeals for the Third Circuit and the U.S. District Court for the District of New Jersey, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Know 'The Record Below': Appellate Pros Talk Argument Prep,&amp;rdquo; following his participation in a panel discussion on preparing for oral arguments at the 2026 Third Circuit Bench and Bar Conference in Hershey, Pennsylvania.</description><pubDate>Mon, 11 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Judge Joseph A. Greenaway Jr., Arnold &amp;amp; Porter partner who formerly served as a judge on both the U.S. Court of Appeals for the Third Circuit and the U.S. District Court for the District of New Jersey, was quoted in the &lt;em&gt;Law360&lt;/em&gt; article, &amp;ldquo;Know 'The Record Below': Appellate Pros Talk Argument Prep,&amp;rdquo; following his participation in a panel discussion on preparing for oral arguments at the 2026 Third Circuit Bench and Bar Conference in Hershey, Pennsylvania.&lt;/p&gt;
&lt;p&gt;Drawing on his decades of experience, Judge Greenaway emphasized the importance of mastering the trial court record, understanding the governing case law, and developing a clear appellate strategy when preparing for oral argument.&lt;/p&gt;
&lt;p&gt;&amp;ldquo;The record below is so important,&amp;rdquo; Judge Greenaway said, noting that appellate advocates must have an &amp;ldquo;intimate understanding&amp;rdquo; of both the factual record and the applicable legal standards.&lt;/p&gt;
&lt;p&gt;Judge Greenaway also discussed the challenges appellate lawyers face in persuading courts to overturn lower court decisions, observing that &amp;ldquo;the statistics bear out that appellate courts are loath to overturn.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2474641/know-the-record-below-appellate-pros-talk-argument-prep-" target="_blank"&gt;Read the full article&lt;/a&gt; (subscription required).&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8CF2F2A5-4D02-470D-8F5E-2625310CD7D0}</guid><link>https://www.biosliceblog.com/2026/05/draft-uk-medical-device-amending-regulations-key-proposals-and-mhra-call-for-evidence/</link><author>eleri.abreo@arnoldporter.com</author><title>Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence</title><pubDate>Mon, 11 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{75702DDF-2FFE-460C-8A17-7C88E9D5221E}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/aron-estaver-returns-to-arnold-porter-as-investment-management-partner-in-san-francisco</link><title>Aron Estaver Returns to Arnold &amp; Porter as Investment Management Partner in San Francisco</title><description>&lt;strong&gt;SAN FRANCISCO, May 8, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Aron Estaver has rejoined the Investment Management team of the Corporate &amp;amp; Finance practice as a partner, affiliated with the firm&amp;rsquo;s San Francisco office.&amp;nbsp;</description><pubDate>Fri, 08 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;SAN FRANCISCO, May 8, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Aron Estaver has rejoined the Investment Management team of the Corporate &amp;amp; Finance practice as a partner, affiliated with the firm&amp;rsquo;s San Francisco office.&lt;/p&gt;
&lt;p&gt;Ellen Kaye Fleishhacker, Arnold &amp;amp; Porter Global Co-Chair and Co-Lead of the firm&amp;rsquo;s Investment Management practice group, said: &amp;ldquo;Aron brings a strong skill set and deep familiarity with our clients and practice, making him a valuable addition to the Investment Management team. His combination of sound judgment, technical depth, and client-oriented approach are hard to come by, and we are pleased to welcome him back to build on his previous 14 years with the firm.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Jonathan Hughes, head of Arnold &amp;amp; Porter&amp;rsquo;s San Francisco and Silicon Valley offices, added: &amp;ldquo;Aron&amp;rsquo;s return reflects the momentum the firm has built in Northern California and our commitment to deepening our capabilities on the West Coast. His deep knowledge, combined with his experience in this market, positions us well to continue serving clients who are central to this region&amp;rsquo;s economy.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Aron&amp;rsquo;s practice &amp;mdash;&amp;nbsp;which spans over 20 years &amp;mdash;&amp;nbsp;primarily focuses on advising U.S. and non-U.S. fund sponsors regarding the structuring and ongoing operation of private investment funds. He works with sponsors pursuing a broad range of investment strategies, including private equity, venture capital, credit, hedge, real estate, and infrastructure. He also regularly advises on the formation and operation of secondary funds, funds-of-funds, co-investment vehicles, joint ventures, separately managed accounts, and other bespoke fund structures. Aron&amp;rsquo;s work includes both sponsor-side structuring and negotiating investor-facing documentation, as well as upper-tier sponsor arrangements. In addition, Aron regularly represents institutional investors, sovereign wealth funds, family offices, and high net worth investors regarding their private fund investments. He also has significant experience advising clients on regulatory, registration, and compliance matters applicable to investment advisers, commodity pool operators, and commodity trading advisors, including matters involving federal and state securities regulators. He works closely with tax, regulatory, employment, litigation, and other transactional colleagues to support client needs, and has experience handling related general corporate and transactional matters.&lt;/p&gt;
&lt;p&gt;In joining the firm, Aron said: &amp;ldquo;Having spent well over a decade at Arnold &amp;amp; Porter, returning to the firm&amp;rsquo;s Investment Management team feels like a natural homecoming. I look forward to resuming work with my former colleagues, growing the practice, and advising clients on private investment fund-related matters.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Prior to rejoining Arnold &amp;amp; Porter, Aron was of counsel in the Private Funds Group at an Am Law 100 law firm. Aron holds a B.A. from Brandeis University and a J.D. from Vanderbilt University Law School. &lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D9971440-175F-4009-A92E-EC474B458044}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/san-francisco-business-times-recognizes-ellen-kaye-fleishhacker</link><title>San Francisco Business Times Recognizes Ellen Kaye Fleishhacker as a Most Influential Woman in Bay Area Business</title><description>Global Co-Chair of Arnold &amp;amp; Porter, Ellen Kaye Fleishhacker, has been named one of the Most Influential Women in Bay Area Business by the &lt;em&gt;San Francisco Business Times&lt;/em&gt;.&amp;nbsp;</description><pubDate>Fri, 08 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Global Co-Chair of Arnold &amp;amp; Porter, Ellen Kaye Fleishhacker, has been named one of the Most Influential Women in Bay Area Business by the &lt;em&gt;San Francisco Business Times&lt;/em&gt;. The award honors trailblazing leaders who are shaping industries, championing mentorship and community impact, and redefining leadership across the region.&lt;/p&gt;
&lt;p&gt;Ellen is a seasoned transactional lawyer and law firm leader who brings clear-headed and practical judgment to help both clients and the firm address complex matters. She has been part of the firm's top leadership since January 2021, when she became Co-Managing Partner, and was subsequently named Global Co-Chair. Under her leadership, Arnold &amp;amp; Porter has continued to thrive as a place where clients can obtain world-class regulatory, litigation, and transactional solutions for their most complex challenges. &lt;/p&gt;
&lt;p&gt;Her profile in the &lt;em&gt;San Francisco Business Times&lt;/em&gt; noted early in her career, a mentor recognized potential in her that she had not yet seen in herself, and that his encouragement led her to pursue both law school and business school &amp;mdash; a decision that shaped her career and sense of what was possible.&lt;/p&gt;
&lt;p&gt;Ellen has also supported and enhanced the firm&amp;rsquo;s deep commitment to excellence in the practice of law and client service, a commitment to collegiality and collaboration, a diverse, equitable, and inclusive culture, and a dedication to pro bono service.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D34508A2-55EC-4D30-8F8A-D9F4F258491C}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/capital-snapshot</link><a10:author><a10:name>Eugenia E. Pierson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/p/pierson-eugenia-e</a10:uri><a10:email>Eugenia.Pierson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Allison Jarus</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jarus-allison</a10:uri><a10:email>allison.jarus@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Peter E. Duyshart</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/duyshart-peter</a10:uri><a10:email>peter.duyshart@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Crawford</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/crawford-emily</a10:uri><a10:email>emily.crawford@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emily Mahaffy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mahaffy-emily</a10:uri><a10:email>emily.mahaffy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dylan L. Kelemen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/k/kelemen-dylan-l</a10:uri><a10:email>dylan.kelemen@arnoldporter.com</a10:email></a10:author><title>Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions</title><description>Our Legislative &amp;amp; Public Policy team is pleased to provide the May 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the Capital Snapshot contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, and recently-announced retirements, resignations, vacancies, and candidacies.</description><pubDate>Fri, 08 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Our Legislative &amp;amp; Public Policy team is pleased to provide the May 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month&amp;rsquo;s edition of the Capital Snapshot contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, and recently-announced retirements, resignations, vacancies, and candidacies. We also share updates pertaining to the FY 2026 and FY 2027 federal funding and the appropriations processes, including updates related to funding the DHS for FY 2026. Our team also provides comprehensive updates on the latest on trade and tariffs. Furthermore, we share some salient legislative and policy updates across a variety of additional key policy areas, including: (1) defense; (2) tax; (3) financial services; (4) artificial intelligence; (5) technology; (6) data privacy; (7) health care; (8) education; and (9) energy and environment. Additionally, we provide an overview and outlook of the upcoming 2026 midterm elections in November, as well as an update to our detailed rundown of various redistricting efforts across the country ahead of the midterms. Our team also takes a look at current public opinion polling on President Trump&amp;rsquo;s job performance and policy priorities, and assesses economic factors and conditions that could impact the future political landscape in an election year.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{4819BE43-D98A-46D4-BADC-252F3FD3AB3E}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/05/digital-assets-the-genius-act</link><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><title>Digital Assets &amp; the GENIUS Act</title><description>This session will address the GENIUS Act and its implications and explore recent developments in the digital asset sector and related opportunities and potential challenges for banking institutions.</description><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Chris Allen and Anthony Raglani from Arnold &amp;amp; Porter&amp;rsquo;s Financial Services group will present at the New Jersey Bankers Association&amp;rsquo;s (NJBankers) 120th annual conference in New Orleans, LA. Their session will address the GENIUS Act and its implications. Their discussion will also explore recent developments in the digital asset sector. Finally, the session will also consider emerging opportunities and potential challenges for banking institutions.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{5BBDAA01-467B-4890-852B-9CDB2C779CB4}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/05/in-the-room-former-officials-on-national-security-and-other-enforcement-issues</link><a10:author><a10:name>Henry D. Almond</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/almond-henry-d</a10:uri><a10:email>henry.almond@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John P. Barker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/barker-john-p</a10:uri><a10:email>john.barker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>John B. Bellinger, III</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bellinger-john-b</a10:uri><a10:email>john.bellinger@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eun Young Choi</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/choi-eun-young</a10:uri><a10:email>EunYoung.Choi@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Rachel F. Cotton</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cotton-rachel-f</a10:uri><a10:email>rachel.cotton@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Burden H. Walker</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/walker-burden-h</a10:uri><a10:email>burden.walker@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tirzah S. Lollar</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lollar-tirzah-s</a10:uri><a10:email>tirzah.lollar@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Soo-Mi Rhee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rhee-soomi</a10:uri><a10:email>soo-mi.rhee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christian D. Sheehan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sheehan-christian</a10:uri><a10:email>christian.sheehan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nicholas L. Townsend</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/townsend-nicholas-l</a10:uri><a10:email>nicholas.townsend@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ronald D. Lee</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lee-ronald-d</a10:uri><a10:email>Ronald.Lee@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ambassador Barbara A. Leaf</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/leaf-barbara-a</a10:uri><a10:email>barbara.leaf@arnoldporter.com</a10:email></a10:author><title>In the Room: Former Officials on National Security and Other Enforcement Issues and What It Means for Your Business</title><description>Legal risk for contractors and cross-border businesses is not driven solely by statute or regulation &amp;mdash; it is shaped by geopolitics, Administration and congressional priorities, and enforcement discretion.</description><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Legal risk for contractors and cross-border businesses is not driven solely by statute or regulation &amp;mdash; it is shaped by geopolitics, Administration and congressional priorities, and enforcement discretion. The regulators and prosecutors enforcing export controls, foreign investment restrictions, False Claims Act, and sanctions laws, have new priorities, new tools, and new targets &amp;mdash; which may change against the background of the upcoming midterms. Adding to this complexity, the rapid advancement of artificial intelligence has introduced a new frontier of national security concern, for which regulators are grappling with how existing frameworks apply &amp;mdash; and where new enforcement mechanisms may be needed. Today&amp;rsquo;s enforcement environment is moving quickly, with up-to-the-minute developments affecting global trade, national security, AI governance, and cross-border operations in ways that demand close attention.&lt;/p&gt;
&lt;p&gt;Join us for a half-day, in-person program where Arnold &amp;amp; Porter's national security practitioners &amp;mdash; many of whom are former senior officials of the Department of Justice, the Intelligence Community, and the Department of State &amp;mdash; along with our Export Control, CFIUS, Congressional Investigations and False Claims Act teams will give you their views on these priorities, tools, and targets and what it means for your organization right now.&lt;/p&gt;
&lt;h2&gt;Agenda and Speakers&lt;/h2&gt;
&lt;strong&gt;The Algorithmic Arms Race:  AI Exposing Hidden Vulnerabilities&lt;/strong&gt;&lt;br /&gt;
Eun Young Choi | Partner&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;The Shifting National Security Landscape&lt;/strong&gt;&lt;br /&gt;
John B. Bellinger, III | Partner&lt;br /&gt;
Ambassador Barbara A. Leaf | Senior International Policy Advisor&lt;br /&gt;
Ronald D. Lee | Senior Counsel&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;After the Midterms: Congressional Investigations&lt;/strong&gt;&lt;br /&gt;
Rachel F. Cotton | Partner&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;False Claims Act Frontiers: Cybersecurity, Tariffs &amp;amp; Impact of Changes at DOJ&lt;/strong&gt;&lt;br /&gt;
Burden H. Walker | Partner&lt;br /&gt;
Henry D. Almond | Partner&lt;br /&gt;
Tirzah S. Lollar | Partner&lt;br /&gt;
Christian D. Sheehan | Partner&lt;br /&gt;
&lt;br /&gt;
&lt;strong&gt;Export Controls, Sanctions &amp;amp; National Security Enforcement&lt;/strong&gt;&lt;br /&gt;
Eun Young Choi | Partner&lt;br /&gt;
John P. Barker | Partner&lt;br /&gt;
Soo-Mi Rhee | Partner&lt;br /&gt;
Nicholas L. Townsend | Partner&lt;br /&gt;</a10:content></item><item><guid isPermaLink="false">{927DB4DD-D7CF-4B8B-B066-B81D1819D0E0}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/food-and-drug-law-institute-recognizes-elizabeth-trentacost-as-a-rising-star</link><title>Food and Drug Law Institute Recognizes Elizabeth Trentacost as a Rising Star</title><description>Arnold &amp;amp; Porter senior associate Elizabeth Trentacost has been named a Rising Star by the Food and Drug Law Institute (FDLI) at its annual conference.</description><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter senior associate Elizabeth Trentacost has been named a Rising Star by the Food and Drug Law Institute (FDLI) at its annual conference. FDLI is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law.&lt;/p&gt;
&lt;p&gt;The Rising Star award honors members who "exhibit commitment to the food and drug community and have demonstrated remarkable talents at an early stage of their careers in FDA-regulated fields." Elizabeth was recognized for her leadership on complex pharmaceutical compliance and litigation matters and her commitment to mentorship and community engagement within the field.&lt;/p&gt;
&lt;p&gt;Elizabeth counsels life sciences and consumer products companies on a broad range of FDA regulatory, compliance, enforcement, and strategic matters. She routinely advises on medical product applications and strategy, product development, submissions to and engagement with FDA, good clinical practices, post-marketing issues, and FDA policy development.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{674C0B1C-99F8-4EA4-913E-B47F3F0E8E7D}</guid><link>https://www.biosliceblog.com/2026/05/the-law-commission-of-england-wales-announces-a-review-of-a-potential-new-class-actions-regime/</link><a10:author><a10:name>Libby Amos-Stone</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/amos-libby</a10:uri><a10:email>libby.amos-stone@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Nicola Chesaites</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/chesaites-nicola</a10:uri><a10:email>nicola.chesaites@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katya Farkas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/f/farkas-katya</a10:uri><a10:email>katya.farkas@arnoldporter.com   </a10:email></a10:author><title>The Law Commission of England &amp; Wales Announces a Review of a Potential New Class Actions Regime</title><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{3FF2CEE7-7267-4762-845E-A53C66CD5DB3}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/washington-supreme-court-limits-remedy-of-nonjudicial-foreclosure</link><a10:author><a10:name>Rhys W. Hefta</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hefta-rhys</a10:uri><a10:email>rhys.hefta@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christian Scarlett</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/scarlett-christian</a10:uri><a10:email>christian.scarlett@arnoldporter.com</a10:email></a10:author><title>Washington Supreme Court Limits Remedy of Nonjudicial Foreclosure to Holders of Negotiable Instruments</title><description>On April 30, 2026, the Washington Supreme Court published a decision in the case of&lt;em&gt; Vargas v. RRA CP Opportunity Trust 1&lt;/em&gt; that may have significant ramifications for residential and commercial real estate lenders in the State of Washington.</description><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;On April 30, 2026, the Washington Supreme Court published a decision in the case of&lt;em&gt; Vargas v. RRA CP Opportunity Trust 1&lt;/em&gt; that may have significant ramifications for residential and commercial real estate lenders in the State of Washington. In responding to questions certified to it by the United States District Court for the Western District of Washington, the court built upon a line of precedent, including the landmark &lt;em&gt;Bain v. Metro. Mortg. Grp., Inc.&lt;/em&gt;,[[N: 175 Wn.2d 83, 92-93, 285 P.3d 34 (2012).]] to conclude that only a &amp;ldquo;holder&amp;rdquo; of a negotiable instrument, as contemplated by the Uniform Commercial Code (UCC), can satisfy the prerequisites for conducting a nonjudicial trustee&amp;rsquo;s sale of a property under the Washington Deed of Trust Act (DTA). While the case in question arose in the context of a home equity line of credit (HELOC) and a section of the DTA specific to one-to-four unit residential properties, the logic of the court&amp;rsquo;s decision in &lt;em&gt;Vargas&lt;/em&gt; would appear to extend to commercial financing as well, with substantial implications for a broad range of transactions. At a fundamental level, the decision in &lt;em&gt;Vargas&lt;/em&gt; appears to eliminate the remedy of nonjudicial foreclosure for deeds of trust securing credit agreements, bond indentures, derivative instruments, guaranties, and other non-promissory note debt instruments, as well as deeds of trust securing promissory notes evidencing construction loans, lines of credit and similar facilities with varying principal amounts, and any other promissory note that, inadvertently or by design, does not satisfy the strict criteria for a negotiable instrument under the UCC.&lt;/p&gt;
&lt;h2&gt;Facts of the &lt;em&gt;Vargas&lt;/em&gt; Case&lt;/h2&gt;
&lt;p&gt;Briefly, Gabriel Marquez Vargas obtained both a mortgage loan and a HELOC to finance the acquisition of a home in 2005. The HELOC had a 60-month draw period followed by a 180-month repayment period. In 2011, shortly following the expiration of the draw period, Marquez Vargas defaulted on the repayment of the HELOC. After several assignments of the HELOC and the deed of trust securing it, Real Time Resolutions Inc. (RTR), the servicer of the debt on behalf of RRA CP Opportunity Trust 1 (RRA), executed a beneficiary declaration confirming that RRA was the &amp;ldquo;holder&amp;rdquo; of the HELOC agreement. Such a declaration is a prerequisite to commencing a nonjudicial trustee&amp;rsquo;s sale under the DTA with respect to residential properties containing one to four units.[[N: See RCW 61.24.030, which reads &amp;ldquo;It shall be requisite to a trustee&amp;rsquo;s sale: &amp;hellip; (7)(a) That, for residential real property of up to four units, before the notice of trustee&amp;rsquo;s sale is recorded, transmitted, or served, the trustee shall have proof that the beneficiary is the holder of any promissory note or other obligation secured by the deed of trust. A declaration by the beneficiary made under the penalty of perjury stating that the beneficiary is the holder of any promissory note or other obligation secured by the deed of trust shall be sufficient proof as required under this subsection.&amp;rdquo;]] Marquez Vargas sued in federal court to block the sale.&lt;/p&gt;
&lt;h2&gt;Certified Questions&lt;/h2&gt;
&lt;p&gt;The District Court certified two questions to the Washington Supreme Court as follows:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&amp;ldquo;(1) Whether a typical HELOC agreement that has a closed draw period and specified maturity date is a negotiable instrument under Article 3 of Washington&amp;rsquo;s Uniform Commercial Code? &amp;hellip;&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(2) Whether an alleged beneficiary under the Deed of Trust Act satisfies the requirement to show that it is &amp;lsquo;the holder of any promissory note or other obligation secured by the deed of trust,&amp;rsquo; [RCW][[N: The Revised Code of Washington is referred to throughout this text as RCW.]] 61.24.030(7)(a), by executing a declaration under penalty of perjury attesting that it is the holder of a HELOC agreement?&amp;rdquo; [A footnote contained in the quotation has been omitted].&lt;/p&gt;
&lt;p&gt;The Washington Supreme Court answered &amp;ldquo;No&amp;rdquo; to both of these questions.&lt;/p&gt;
&lt;h2&gt;The Washington Supreme Court&amp;rsquo;s Analysis&lt;/h2&gt;
&lt;p&gt;The court noted that the DTA does not include a definition of &amp;ldquo;Holder,&amp;rdquo; and then cited its own precedent, most notably &lt;em&gt;Bain&lt;/em&gt;, for the proposition that the UCC is the appropriate source for this definition. &lt;/p&gt;
&lt;p&gt;The UCC definition of &amp;ldquo;Holder&amp;rdquo; is set forth in UCC 1-201(21)(A)[[N: Codified in Washington at RCW 62A.1-201(21).]] as:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&amp;ldquo;&amp;lsquo;Holder&amp;rsquo; with respect to a negotiable instrument, means:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(A) The person in possession of a negotiable instrument that is payable either to bearer or to an identified person that is the person in possession.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In this connection, the court notes the fact that the definition of Holder, while found in the general definitions section in Article 1 of the UCC, is used only in connection with negotiable instruments. As such, the court introduces the UCC definition of &amp;ldquo;Negotiable Instrument&amp;rdquo; from UCC 3-104(a)[[N: Codified in Washington at RCW 62A.3-104.]] as follows:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&amp;ldquo;[a]n unconditional promise or order to pay a fixed amount of money, with or without interest or other charges described in the promise or order, if it:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(1) Is payable to bearer or to order at the time it is issued or first comes into possession of a holder;&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(2) Is payable on demand or at a definite time; and&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;(3) Does not state any other undertaking or instruction by the person promising or ordering payment to do any act in addition to the payment of money, but the promise or order may contain (i) an undertaking or power to give, maintain, or protect collateral to secure payment, (ii) an authorization or power to the holder to confess judgment or realize on or dispose of collateral, (iii) a waiver of the benefit of any law intended for the advantage or protection of an obligor, (iv) a term that specifies the law that governs the promise or order, or (v) an undertaking to resolve in a specified forum a dispute concerning the promise or order.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The court&amp;rsquo;s opinion discussed at length the history and function of negotiable instruments, the UCC principles countenancing a bifurcation between the ownership of a negotiable instrument and the right to enforce it, and its own recent precedent on the concept of &amp;ldquo;holder&amp;rdquo; under the DTA and the legislative history of amendments to the DTA in response to that precedent, among other things. Ultimately, though, the court&amp;rsquo;s decision turned on the straightforward definitional proposition that only a negotiable instrument can have a &amp;ldquo;holder.&amp;rdquo; As such, we will focus on that portion of the court&amp;rsquo;s analysis here.&lt;/p&gt;
&lt;p&gt;The HELOC in question in &lt;em&gt;Vargas&lt;/em&gt; did not constitute &amp;ldquo;[a]n unconditional promise or order to pay a fixed amount of money,&amp;rdquo; because the principal amount of the HELOC was variable and dependent on whether the borrower requested and received advances. While the principal amount of the HELOC was in fact fixed at the time of the default, by virtue of the draw period having expired, the court rejected the argument that this rendered the HELOC a negotiable instrument. Since it was not a negotiable instrument when made, and since the payment terms were not ascertainable solely from the four corners of the document, it could never be a negotiable instrument. The court cited a prior appellate decision for the proposition that &amp;ldquo;[n]egotiability is determined from the face, the four corners, of the instrument at the time it is issued without reference to extrinsic facts.&amp;rdquo;[[N: &lt;em&gt;Bucci v. Nw. Tr. Servs., Inc.&lt;/em&gt;, 197 Wn. App. 318, 329, 387 P.3d 1139 (2016), itself citing early sources as set out in full in &lt;em&gt;Vargas&lt;/em&gt;.]]&lt;/p&gt;
&lt;p&gt;Because the HELOC in &lt;em&gt;Vargas&lt;/em&gt; could not satisfy the criteria for negotiability necessary to be classified as a negotiable instrument under the UCC, the beneficiary of the deed of trust securing the HELOC could never make the declaration that it was the &amp;ldquo;holder&amp;rdquo; of the obligation secured by the deed of trust as required under RCW 61.24.030. By extension, the beneficiary could never satisfy the prerequisite for a trustee&amp;rsquo;s sale under the DTA. The beneficiary in &lt;em&gt;Vargas&lt;/em&gt;, then, would appear to be left with the option of pursuing a judicial foreclosure instead.&lt;/p&gt;
&lt;h2&gt;Implications&lt;/h2&gt;
&lt;p&gt;The application of &lt;em&gt;Vargas&lt;/em&gt; in the residential context is quite clear, as any deed of trust securing a HELOC or similar residential or consumer debt instrument in Washington will no longer be susceptible to nonjudicial foreclosure. But that does not appear to be the end of the likely far-reaching application of this decision. While the court, responding to the specific questions certified by the trial court, focused on the beneficiary declaration requirement of RCW 61.24.030(7)(a), which is only applicable to one-to-four unit residential properties, it is important to note that the DTA defines the beneficiary for all purposes, residential and commercial, as &amp;ldquo;the &lt;em&gt;holder&lt;/em&gt; of the instrument or document evidencing the obligations secured by the deed of trust, excluding persons holding the same as security for a different obligation.&amp;rdquo;[[N: RCW 61.24.005(2) (emphasis added).]] The court cited &lt;em&gt;Bain&lt;/em&gt; for the proposition that &amp;ldquo;holder&amp;rdquo; for purposes of the DTA should be defined in accordance with the UCC, and the decision in &lt;em&gt;Bain&lt;/em&gt; turned on this very definition of beneficiary, and whether a party that was not the holder of a note had the power to direct a trustee to commence a nonjudicial foreclosure. &lt;em&gt;Vargas&lt;/em&gt; appears to simply extend the reasoning in &lt;em&gt;Bain&lt;/em&gt; by looking not just to the identity of the purported holder but to the nature of the instrument purported to be held. There is no reason to think that this definitional analysis would be limited to the usage of &amp;ldquo;holder&amp;rdquo; in the narrow residential context of RCW 61.24.030(7)(a) when the definition of &amp;ldquo;beneficiary&amp;rdquo; applies to the entirety of the DTA.&lt;/p&gt;
&lt;p&gt;Assuming that the logic of &lt;em&gt;Vargas&lt;/em&gt; will extend to commercial transactions as well, there would appear to be a number of broad classes of indebtedness and other obligations in Washington traditionally secured by deeds of trust that would likely not qualify as negotiable instruments under the UCC. These would include deeds of trust securing:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Credit agreements containing broad covenants and other obligations and with no separate promissory note&lt;/li&gt;
    &lt;li&gt;Bond indentures, derivative instruments, letters of credit, guaranties, indemnities, private liens, and other non-promissory note debt instruments&lt;/li&gt;
    &lt;li&gt;Construction loans, lines of credit, multiple advance notes, and other instruments that, by their nature, provide for a variable principal amount that cannot be specified at the inception of the instrument&lt;/li&gt;
    &lt;li&gt;Registered notes, which are transferable only by recordation in a centrally maintained registry and are therefore not negotiable&lt;/li&gt;
    &lt;li&gt;Notes that contain additional nonpayment obligations that are not permitted under UCC 3-104(a)(3)&lt;/li&gt;
    &lt;li&gt;Notes that broadly defer to a loan agreement or other separate document for full payment terms&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The most apparent option available to a lender holding one of the above instruments is a judicial foreclosure of the deed of trust as a mortgage under RCW 61.12 (Washington&amp;rsquo;s judicial foreclosure statute). While a full analysis of the positives and negatives of judicial foreclosures in Washington is beyond the scope of this Advisory, there are certain drawbacks to this approach. The cost and time necessary to complete a judicial foreclosure and resulting sheriff&amp;rsquo;s sale of the property will generally be greater, and this can be expected to be exacerbated if the judiciary and sheriffs&amp;rsquo; offices become burdened by increased volume as a result of &lt;em&gt;Vargas&lt;/em&gt;. Perhaps more notably, borrowers in Washington are entitled to a one-year right of redemption following completion of the sale &amp;mdash; meaning the borrower may reacquire the property by paying the outstanding debt as of the time of sale, plus interest, taxes, and certain assessments &amp;mdash; even if the property has been sold to a third party. With very limited exceptions, the owner of the property during the redemption period is not entitled to recompense for any additional investment made into the property during that interim period.[[N: See RCW 6.23.020.]] This is a significant drawback to judicial foreclosure for properties that require operational or capital investment, or for ongoing construction projects that require additional funds for completion. &lt;/p&gt;
&lt;p&gt;Another potential option that lenders may consider is seeking the appointment of a general receiver with power of sale. Under RCW 7.60, a court may appoint a general receiver to &amp;ldquo;take possession and control of substantially all of a person&amp;rsquo;s property with authority to liquidate that property &amp;hellip;&amp;rdquo;[[N: RCW 7.60.015.]] Subject to the court&amp;rsquo;s approval, any such sale would be made free and clear of liens and rights of redemption pursuant to RCW 7.60.260. Again, a full analysis of the positives and negatives of such an approach is beyond the scope of this Advisory, but it seems likely that lenders confronting the realities of a judicial foreclosure following &lt;em&gt;Vargas&lt;/em&gt; will find receivership to be an attractive option.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{B37D1102-5F38-48CC-B78A-C397828B2587}</guid><link>https://www.biosliceblog.com/2026/05/eu-ai-act-omnibus-provisional-deal-announced-initial-reflections-for-life-sciences-companies/</link><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Camille Vermosen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vermosen-camille</a10:uri><a10:email>camille.vermosen@arnoldporter.com</a10:email></a10:author><title>EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections for Life Sciences Companies</title><pubDate>Thu, 07 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{CC9C5E28-2A73-4E88-89A7-15AFE036D701}</guid><link>https://www.biosliceblog.com/2026/05/eu-implements-new-rules-on-uniform-procedural-requirements-for-notified-body-assessments/</link><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher Bates</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/bates-christopher</a10:uri><a10:email>christopher.bates@arnoldporter.com</a10:email></a10:author><title>EU Implements New Rules on Uniform Procedural Requirements for Notified Body Assessments</title><pubDate>Wed, 06 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{92645F12-B2B4-47C6-A24A-5B4E1D5086DB}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/05/four-things-to-know-about-the-cfpbs-final-rule</link><a10:author><a10:name>Amber A. Hay</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hay-amber-a</a10:uri><a10:email>amber.hay@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kevin M. Toomey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/toomey-kevin-m</a10:uri><a10:email>kevin.toomey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kara Ramsey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/ramsey-kara</a10:uri><a10:email>kara.ramsey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>George Eichelberger</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/eichelberger-george</a10:uri><a10:email>George.Eichelberger@arnoldporter.com</a10:email></a10:author><title>Four Things to Know About the CFPB’s Final Rule Revising Small Business Lending Data Collection Under Regulation B</title><description>The CFPB&amp;rsquo;s May 2026 final rule revises the Section 1071 small business lending data collection framework under Regulation B by significantly narrowing the scope of institutions, borrowers, transactions, and data points subject to reporting requirements. The rule raises reporting thresholds, excludes certain categories of lending such as merchant cash advances and agricultural loans, and streamlines required data collection obligations, while signaling that the CFPB may expand the framework incrementally through future rulemakings. Financial institutions should evaluate whether they remain covered by the revised rule, continue monitoring ongoing litigation challenging Section 1071 implementation, and assess the operational and compliance implications ahead of the January 1, 2028 compliance date.</description><pubDate>Wed, 06 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;On May 1, 2026, the Consumer Financial Protection Bureau (CFPB) published a final rule[[N:91 Fed. Reg. 23530 (May 1, 2026).]] (the Final Rule) revising the CFPB&amp;rsquo;s small business lending data collection regime under section 1071 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Section 1071). Section 1071 amended the Equal Credit Opportunity Act (ECOA) to require financial institutions to collect and report data on credit applications by small, women-owned, and minority-owned businesses. The Final Rule narrows, but does not rescind, the small business lending data collection regime established by the CFPB&amp;rsquo;s May 2023 final rule (the 2023 Final Rule),[[N:88 Fed. Reg. 35150 (May 31, 2023).]] which since its adoption has been the subject of ongoing litigation in three federal courts. In making these changes, the CFPB has sought to limit the rule as much as possible to what is strictly required by statute.&lt;/p&gt;
&lt;p&gt;Pointing to the gradual evolution of data collection under the Home Mortgage Disclosure Act (HMDA) over the past 50 years, the CFPB concluded that long-term data collection under Section 1071 should commence with a focus on core lending products, lenders, small businesses, and data points, with future expansions reserved for subsequent notice-and-comment rulemakings. In doing so, the CFPB concluded that the 2023 Final Rule&amp;rsquo;s expansive approach to coverage was not conducive to the long-term success of the Section 1071 framework.[[N:91 Fed. Reg. at 23532 (&amp;ldquo;The Bureau believes in retrospect that the approach it took in the 2023 final rule&amp;mdash;a broad initial coverage of lenders, products, small businesses and data points&amp;mdash;was not conducive to the long-term success of the data collection regime under section 1071.&amp;rdquo;).]]&lt;/p&gt;
&lt;p&gt;The Final Rule is effective June 30, 2026, with a compliance date of January 1, 2028, and a one-year grace period running through December 31, 2028.&lt;/p&gt;
&lt;p&gt;Below are four key points about the Final Rule for consideration by financial institutions.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;1.&amp;nbsp; Fewer Institutions Will Be Required to Report Data to the CFPB&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The Final Rule raises the origination threshold for being a &amp;ldquo;covered financial institution&amp;rdquo; tenfold, increasing it to 1,000 covered credit originations (rather than 100) in each of the two preceding calendar years, and separately excludes Farm Credit System (FCS) lenders from coverage altogether. These changes are expected to reduce substantially the number of community banks, credit unions, and other smaller institutions subject to the rule.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;2.&amp;nbsp; Fewer Borrowers Will Qualify as &amp;ldquo;Small Businesses&amp;rdquo; That Trigger Reporting Obligations&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The Final Rule lowers the gross annual revenue threshold in the definition of &amp;ldquo;small business&amp;rdquo; from $5 million or less to $1 million or less, narrowing the universe of borrowers whose applications trigger the Final Rule&amp;rsquo;s data reporting requirement.[[N:Id. at 23532, 23556-58; see also 12 C.F.R. &amp;sect; 1002.106(b).]] The threshold remains subject to the existing five-year inflation adjustment set forth under Regulation B.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;3.&amp;nbsp; Three New Kinds of Excluded Transactions That Do Not Require Data Reporting&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The Final Rule adds three new categories of transactions to the list of &amp;ldquo;excluded transactions&amp;rdquo; under 12 C.F.R. &amp;sect; 1002.104(b) that do not require data reporting:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Merchant cash advances (MCAs)&lt;/strong&gt;. MCAs are agreements under which a small business receives a lump-sum payment in exchange for the right to receive a percentage of the small business&amp;rsquo; future sales or income up to a ceiling amount.[[N:91 Fed. Reg. at 23539, 23541; see also 12 C.F.R. &amp;sect; 1002.104(b)(7).]] The CFPB notably declined to take a categorical position on whether MCAs constitute &amp;ldquo;credit&amp;rdquo; under ECOA, instead deferring the question pending further market analysis and case-law development.[[N:91 Fed. Reg. at 23539.]]&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Agricultural lending&lt;/strong&gt;. Agricultural lending is generally defined as lending to fund the production of crops, fruits, vegetables, and livestock, or to fund the purchase or refinance of capital assets such as farmland, machinery and equipment, breeder livestock, and farm real estate improvements.[[N:91 Fed. Reg. at 23542-43; see also 12 C.F.R. &amp;sect; 1002.104(b)(8).]] The CFPB cited existing data collection by the Farm Credit Administration, the U.S. Department of Agriculture&amp;rsquo;s Farm Service Agency, and Community Reinvestment Act reporting as already providing meaningful visibility into agricultural lending.[[N:91 Fed. Reg. at 23543.]]&lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Small dollar business credit&lt;/strong&gt;. Small dollar business credit is defined to be credit in an amount of $1,000 or less, subject to inflation adjustment.[[N:Id. at 23544-45; see also 12 C.F.R. &amp;sect; 1002.104(b)(9).]]&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;4.&amp;nbsp; A Streamlined Set of Required Data Points&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The Final Rule limits required data collection to the data points specifically enumerated in Section 1071, plus a limited subset necessary to facilitate collection of those statutory items.[[N:91 Fed. Reg. at 23532, 23558.]] Accordingly, the Final Rule eliminates several discretionary data points that the 2023 Final Rule had required, including: (1) application method, (2) application recipient, (3) denial reasons, (4) pricing information, and (5) number of workers.[[N:Id. at 23532, 23558-62.]] In addition, the Final Rule revises the format for collecting demographic information about principal owners and the business ownership status data point to align with Executive Order 14168.[[N:Exec. Order No. 14168, 90 Fed. Reg. 8615 (Jan. 30, 2025); see also Final Rule, 91 Fed. Reg. at 23531-32, 23564-67.]]&lt;/p&gt;
&lt;h2&gt;Three Practical Takeaways&lt;/h2&gt;
&lt;p&gt;First, financial institutions should reassess their status against the new institutional and small business thresholds to determine whether the CFPB&amp;rsquo;s small business lending data collection requirements still apply to them. Many institutions covered by the 2023 Final Rule &amp;mdash; particularly community banks, credit unions, and FCS lenders &amp;mdash; may now fall outside the rule entirely, while others may move in or out of coverage as origination volumes shift across calendar years.&lt;/p&gt;
&lt;p&gt;Second, institutions that remain covered should continue their Section 1071 implementation work rather than scaling it back. The CFPB has signaled that the Final Rule represents the first phase of an incremental, HMDA-style framework, and future rulemakings may reintroduce some of the products, lenders, or data points removed by the Final Rule.[[N:See Final Rule, 91 Fed. Reg. at 23531 (the CFPB &amp;ldquo;should approach the section 1071 data collection regime as a longer-term project akin to HMDA&amp;rdquo;); see also id. at 23541 (MCAs), 23552 (FCS lenders), 23559 (application method) (each indicating possible future reconsideration).]] Institutions that had begun to implement the rule but are now no longer covered should nonetheless retain the work that has been done in preparation for possible future changes.&lt;/p&gt;
&lt;p&gt;Third, the Final Rule does not necessarily moot the pending litigation challenging the 2023 Final Rule in &lt;em&gt;Texas Bankers Association v. CFPB&lt;/em&gt;,[[N:&lt;em&gt;Texas Bankers Ass&amp;rsquo;n v. CFPB&lt;/em&gt;, No. 7:23-CV-00144 (S.D. Tex.); see also &lt;em&gt;Texas Bankers Ass&amp;rsquo;n v. CFPB&lt;/em&gt;, No. 24-40705 (5th Cir.).]] &lt;em&gt;Monticello Banking Co. v. CFPB&lt;/em&gt;,[[N:&lt;em&gt;Monticello Banking Co. v. CFPB&lt;/em&gt;, No. 6:23-CV-00148-KKC (E.D. Ky.).]] and &lt;em&gt;Revenue Based Finance Coalition v. CFPB&lt;/em&gt;.[[N:&lt;em&gt;Revenue Based Fin. Coal. v. CFPB&lt;/em&gt;, No. 1:23-CV-24882-DSL (S.D. Fla.).]] Institutions should continue to monitor those cases for developments that may affect the new Final Rule.&lt;/p&gt;
&lt;p style="text-align: center;"&gt;* &amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; * &amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; *&lt;/p&gt;
&lt;p&gt;If you would like to discuss the Final Rule or how it may affect your institution, please contact any of the authors of this Advisory or your usual Arnold &amp;amp; Porter contact.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{56E8AFD3-BA90-47E5-8953-275D0494CB0B}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/arnold-porter-expands-european-antitrust-litigation-team-with-addition-of-partner-nicola-chesaites</link><title>Arnold &amp; Porter Expands European Antitrust Litigation Team with Addition of Partner Nicola Chesaites</title><description>&lt;strong&gt;LONDON and WASHINGTON, D.C.&lt;/strong&gt;, May 5, 2026 &amp;mdash; Arnold &amp;amp; Porter announced today that Nicola Chesaites has joined the firm&amp;rsquo;s Antitrust/Competition litigation practice as a partner, resident in London.&amp;nbsp;</description><pubDate>Tue, 05 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;&lt;strong&gt;LONDON and WASHINGTON, D.C., May 5, 2026&lt;/strong&gt; &amp;mdash; Arnold &amp;amp; Porter announced today that Nicola Chesaites has joined the firm&amp;rsquo;s Antitrust/Competition litigation practice as a partner, resident in London. &lt;/p&gt;
&lt;p&gt;Kathleen Harris, head of Arnold &amp;amp; Porter&amp;rsquo;s London office, said: &amp;ldquo;Nicola is widely recognized as a leading competition litigator and for her skill in navigating complex litigation risk and strategic advisory work. Her arrival strengthens our robust competition and commercial litigation practices. She will be a great addition to Arnold &amp;amp; Porter&amp;rsquo;s London team.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Niels Christian Ersb&amp;oslash;ll, Global Co-Chair of Arnold &amp;amp; Porter&amp;rsquo;s Antitrust/Competition practice group and head of the Brussels office, added: &amp;ldquo;Nicola&amp;rsquo;s unique dual qualification as both a barrister and a Belgian advocate will be a significant asset, enhancing our ability to support clients across the UK and EU in their cross-border antitrust matters and interconnected litigation, regulatory, and transactional needs. We are delighted to welcome her to the firm.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Nicola is a UK-qualified barrister and a Belgian advocaat with more than 17 years of experience in competition damages litigation, collective (class) actions under the UK&amp;rsquo;s private enforcement regime, and complex European Union litigation. She has represented claimants and defendants before the English courts and the UK Competition Appeal Tribunal, and appeared before the EU General Court and Court of Justice on behalf of corporates and EU institutions in a range of EU law disputes ranging from banking resolution, trade, sanctions, pharmaceuticals, and transportation disputes.&lt;/p&gt;
&lt;p&gt;In joining the firm, Nicola said: &amp;ldquo;As regulatory regimes evolve and with the increase in private enforcement of competition law in Europe, and the rapid growth in collective actions in the UK, litigation risk is increasingly complex for clients active in multiple markets. Arnold &amp;amp; Porter&amp;rsquo;s integrated platform and global footprint make it an ideal environment for my practice and I look forward to collaborating with colleagues in Europe and globally to provide clients with advice on their antitrust, regulatory, and litigation risks.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Nicola holds an LL.M. from the College of Europe, an LL.B. from the University of Westminster, and a License in French Law from Universit&amp;eacute; Paris X Nanterre.&lt;/p&gt;
&lt;h3&gt;About Arnold &amp;amp; Porter&lt;/h3&gt;
&lt;p&gt;&lt;em&gt;Arnold &amp;amp; Porter combines sophisticated regulatory, litigation, and transactional capabilities to resolve clients&amp;rsquo; most complex issues. With over 1,000 lawyers practicing in 16 offices worldwide, we offer an integrated approach that spans more than 40 practice areas. Through multidisciplinary collaboration and focused industry experience, we provide innovative and effective solutions to mitigate risks, address challenges, and achieve successful outcomes.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{C0812EAD-1B12-4CE6-AD1F-3360F2FAE3BC}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/arnold-porter-advises-d-e-shaw-ventures-on-openai-anthropic-investments</link><title>Arnold &amp; Porter Advises D. E. Shaw Ventures on OpenAI, Anthropic Investments</title><description>Arnold &amp;amp; Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group&amp;rsquo;s venture capital and growth equity arm, on investments in OpenAI and Anthropic.</description><pubDate>Tue, 05 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group&amp;rsquo;s venture capital and growth equity arm, on investments in OpenAI and Anthropic.&lt;/p&gt;
&lt;p&gt;Most recently, the firm counseled D. E. Shaw Ventures on its Series C investment in OpenAI. This investment was part of the $122 billion financing round, co-led by D. E. Shaw Ventures, which valued OpenAI at $852 billion post-money and closed on March 31, 2026. Arnold &amp;amp; Porter previously advised D. E. Shaw Ventures in an investment ahead of OpenAI&amp;rsquo;s $6.6 billion tender offer, which was completed in October 2025.&lt;/p&gt;
&lt;p&gt;The firm also recently represented D. E. Shaw Ventures in connection with its role as a co-lead in Anthropic&amp;rsquo;s $30 billion Series G financing round, which valued Anthropic at $380 billion post-money and closed on February 12, 2026.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team counseling D. E. Shaw Ventures on the OpenAI investment was led by partner Marina Richter and included partners Stephanie Coutu and Ed Deibert, senior counsel Joel Greenberg, senior attorney Stacie Jeong, senior associate Trevor Schmitt, and associate Anna Cardoso. Partner Reuven Graber and counsel Kathleen Wechter provided tax advice.&lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team counseling D. E. Shaw Ventures on the Anthropic investment was led by partner Marina Richter and included partner Stephanie Coutu, counsel Peter Danias, senior attorney Stacie Jeong, and associate Anna Cardoso. Partners Deborah Curtis and Debbie Feinstein provided regulatory and antitrust advice, respectively.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{7F22A90B-A201-4C52-9195-7960232ADB55}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/arnold-porter-defeats-class-certification-in-the-us-district-court</link><title>Arnold &amp; Porter Defeats Class Certification in the U.S. District Court for the Central District of California</title><description>Arnold &amp;amp; Porter has secured another victory for Epoch Everlasting Play, LLC in a consumer products lawsuit over its Calico Critters toy line.</description><pubDate>Mon, 04 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter has secured another victory for Epoch Everlasting Play, LLC in a consumer products lawsuit over its Calico Critters toy line. On May 4, 2026, Judge Wright of the U.S. District Court for the Central District of California denied with prejudice a renewed motion for class certification, eliminating all class claims in the case and barring any future class certification motion.&lt;/p&gt;
&lt;p&gt;Plaintiffs alleged that the Calico Critters products are hazardous and sought to halt sales and obtain full refunds for California purchasers under the state&amp;rsquo;s Unfair Competition Law. Judge Wright held that the plaintiffs could not satisfy Rule 23&amp;rsquo;s adequacy requirement, finding that the named plaintiff&amp;rsquo;s lack of standing to seek injunctive relief, as previously determined by the U.S. Court of Appeals for the Ninth Circuit, created a conflict with absent class members who might still pursue such relief. &lt;/p&gt;
&lt;p&gt;This decision builds on an appellate victory from September 2025, in which the U.S. Court of Appeals for the Ninth Circuit, on interlocutory appeal under Rule 23(f), vacated the district court&amp;rsquo;s initial order granting class certification. &lt;/p&gt;
&lt;p&gt;The Arnold &amp;amp; Porter team was led by partners James Speyer, Ian Hoffman, and William Perdue; senior counsel Eric Rubel; senior associate Henry Morris; and associate Zach Woodward.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{8F3991DD-98E9-4213-A48F-7FE927DB8869}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/05/arnold-porter-advises-brazil-on-landmark-5b-global-bond-offering</link><title>Arnold &amp; Porter Advises Brazil on Landmark €5B Global Bond Offering, Largest Ever and First Euro Issuance Since 2014</title><description>Arnold &amp;amp; Porter advised the Federative Republic of Brazil on its landmark &amp;euro;5 billion global bond offering, which closed on April 23, 2026.</description><pubDate>Mon, 04 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter advised the Federative Republic of Brazil on its landmark &amp;euro;5 billion global bond offering, which closed on April 23, 2026.&lt;/p&gt;
&lt;p&gt;The transaction, the largest international bond issuance in Brazil&amp;rsquo;s history, also marks the country&amp;rsquo;s return to the euro market, with its first euro-denominated bond offering since 2014.&lt;/p&gt;
&lt;p&gt;The offering comprised three tranches: &amp;euro;2 billion of 4.000% Global Bonds due 2030, &amp;euro;1.5 billion of 4.875% Global Bonds due 2033, and &amp;euro;1.5 billion of 5.500% Global Bonds due 2036. All three series were listed on the London Stock Exchange and admitted to trading on its International Securities Market.&lt;/p&gt;
&lt;p&gt;Arnold &amp;amp; Porter regularly advises Brazil on its sovereign financings, including its US$4.5 billion bond offering in February 2026, its &lt;a href="/en/perspectives/news/2025/12/arnold-porter-advises-brazil-on-two-bond-issuances"&gt;US$2.25 billion bond offering&lt;/a&gt;&amp;nbsp;in December 2025, and its &lt;a href="/en/perspectives/news/2025/06/arnold-porter-advises-brazil-on-us2-75-billion-bond-issue"&gt;US$2.75 billion bond offering&lt;/a&gt;&amp;nbsp;in June 2025.&lt;/p&gt;
&lt;p&gt;The team was led by partner Greg Harrington, counsel Carlos Pelaez, senior associate Mateo Morris, and associate Remila Jasharllari.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;*Bruno Woicik, a visiting attorney from Brazil, also assisted the team. Mr. Woicik is admitted to practice law only in Brazil and is not engaged in the practice of law in any U.S. jurisdiction.&lt;/em&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{DFF58E99-C67B-4C08-98AD-4A5734EDC821}</guid><link>https://lawreview.syr.edu/wp-content/uploads/2026/05/03_SYR_76_3_Saracino-Mazuzan.pdf</link><a10:author><a10:name>Jacob Saracino</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/saracino-jacob</a10:uri><a10:email>jacob.saracino@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Zachary John Mazuzan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mazuzan-zachary</a10:uri><a10:email>zachary.mazuzan@arnoldporter.com</a10:email></a10:author><title>Constitutional Law: The Safe for Kids Act &amp; The Freedom of Expression</title><pubDate>Sun, 03 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{FAEC1D50-8A65-4C9B-93AD-6E1D926CBEEA}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/audits-are-here-how-should-you-prepare</link><a10:author><a10:name>Paul W. Sweeney, Jr.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/sweeney-jr-paul-w</a10:uri><a10:email>paul.sweeney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Sheena Thomas</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/thomas-sheena</a10:uri><a10:email>sheena.thomas@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alyssa T. Calcerano</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/calcerano-alyssa</a10:uri><a10:email>alyssa.calcerano@arnoldporter.com</a10:email></a10:author><title>Are You Ready — California Cybersecurity Audits Are Here!</title><description>&lt;p&gt;The California Privacy Protection Agency&amp;rsquo;s Executive Director Tom Kemp recently stated that the agency&amp;rsquo;s new Audits Division will begin conducting audits assessing companies&amp;rsquo; compliance with California data privacy laws this year.&lt;/p&gt;</description><pubDate>Fri, 01 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;The California Privacy Protection Agency&amp;rsquo;s (CalPrivacy) Executive Director Tom Kemp recently stated that the agency&amp;rsquo;s new Audits Division will begin conducting audits assessing companies&amp;rsquo; compliance with California data privacy laws this year.[[N:Allison Grande, &lt;a rel="noopener noreferrer" href="https://www.law360.com/articles/2464170/calif-privacy-audits-starting-this-year-agency-s-head-says" target="_blank"&gt;Calif. Privacy Audits Starting This Year, Agency&amp;rsquo;s Head Says&lt;/a&gt;, LAW360 (Apr. 10, 2026).]]&lt;/p&gt;
&lt;h2&gt;What Is the Role of the New Audits Division?&lt;/h2&gt;
&lt;p&gt;CalPrivacy was established in 2020 by the &lt;a rel="noopener noreferrer" href="https://www.caprivacy.org/annotated-cpra-text-with-ccpa-changes/#section1" target="_blank"&gt;California Privacy Rights Act&lt;/a&gt; (CPRA), which amended the California Consumer Privacy Act (CCPA).[[N:Cal. Civ. Code &amp;sect;&amp;sect; 1798.100-1798.199.100.]] The agency is responsible for implementing and enforcing both statutes.&lt;/p&gt;
&lt;p&gt;The CPRA required CalPrivacy to &amp;ldquo;appoint a Chief Privacy Auditor to conduct audits of businesses to ensure compliance&amp;rdquo; with the CCPA and CPRA.[[N:Id. &amp;sect; 1798.199.40(f).]] Accordingly, in February 2026, CalPrivacy formed the new Audits Division, led by Chief Privacy Auditor Sabrina Boyson Ross.[[N:&lt;a rel="noopener noreferrer" href="https://privacy.ca.gov/2026/02/california-privacy-protection-agency-names-sabrina-boyson-ross-as-chief-auditor/" target="_blank"&gt;California Privacy Protection Agency Names Sabrina Boyson Ross as Chief Auditor and Forms New Audits Division&lt;/a&gt;, PRIVACY.CA.GOV (Feb. 3, 2026).]] Ross joined CalPrivacy after serving in senior privacy and policy leadership roles, most recently serving as the Director of Public Policy at Meta.[[N:Id.]]&lt;/p&gt;
&lt;p&gt;The newly formed Audits Division, announced February 3, 2026, has been described by Executive Director Kemp as the &amp;ldquo;point folks&amp;rdquo; for cybersecurity audit certifications[[N:See The Privacy Advisor Podcast, &lt;a rel="noopener noreferrer" href="https://privacyadvisorpodcast.libsyn.com/california-privacy-enforcement-in-2026-a-discussion-with-calprivacys-tom-kemp" target="_blank"&gt;California privacy enforcement in 2026: A discussion with CalPrivacy&amp;rsquo;s Tom Kemp&lt;/a&gt;, IAPP, at 00:22:50-00:25:06 (Feb. 6, 2026).]] and is responsible for developing and applying privacy compliance audit procedures and examining businesses&amp;rsquo; practices for compliance gaps.[[N:California Privacy Protection Agency Names Sabrina Boyson Ross as Chief Auditor and Forms New Audits Division, supra note 5.]] It will also be responsible for processing risk assessment attestations under Article 10 of the new CCPA regulations, as well as the cybersecurity audit certifications under Article 9.&lt;/p&gt;
&lt;h2&gt;When Should You Expect Audits To Start?&lt;/h2&gt;
&lt;p&gt;As directed by the CPRA, CalPrivacy created annual cybersecurity audit requirements[[N:Cal. Code Regs. tit. 11, art. 9 (2026) (hereinafter CCPA Regs.).]] for &amp;ldquo;businesses whose processing of consumers&amp;rsquo; personal information presents significant risk to consumers&amp;rsquo; privacy or security.&amp;rdquo;[[N:Cal. Civ. Code &amp;sect; 1798.185(a)(14)(A).]] Although these audit requirements formally took effect January 1, 2026, initial cybersecurity audit certifications are not due until 2028 to 2030, depending on the business&amp;rsquo;s annual gross revenue in the preceding year.[[N:CCPA Regs. &amp;sect; 7121(a)(1)-(3).]]&lt;/p&gt;
&lt;p&gt;While this statutory deadline may appear to afford organizations ample time to complete their first cybersecurity audits, Executive Director Kemp&amp;rsquo;s recent announcement of audits beginning this year indicates otherwise.&lt;/p&gt;
&lt;p&gt;Kemp has acknowledged that although audit certifications will not be due until at least 2028, CalPrivacy expects that &amp;ldquo;by nature, people are just doing cybersecurity audits anyway&amp;rdquo; given that &amp;ldquo;other regimes and other regulations&amp;rdquo; impose similar requirements.[[N:The Privacy Advisor Podcast, supra note 7, at 00:22:14-00:22:58, 00:23:11-00:24:00.]]&lt;/p&gt;
&lt;p&gt;Other states do have laws requiring cybersecurity audits. New York, for example, imposes cybersecurity program and audit-type obligations on financial services entities,[[N:See 23 NYCRR 500.]] and a number of states have adopted insurance data security laws modeled on the &lt;a rel="noopener noreferrer" href="https://content.naic.org/sites/default/files/model-law-668.pdf" target="_blank"&gt;National Association of Insurance Commissioners Model Law&lt;/a&gt;. However, California&amp;rsquo;s regulations uniquely extend cybersecurity audit certification obligations to any qualifying business across sectors.&lt;/p&gt;
&lt;p&gt;In other words, do not treat this delayed certification deadline as a grace period: the Audits Division is here and expects your cybersecurity audit practices to be underway now.&lt;/p&gt;
&lt;h2&gt;What Will Be the Focus of These Audits?&lt;/h2&gt;
&lt;p&gt;CalPrivacy has not explicitly identified the initial focus of its audits, but Executive Director Kemp has stated that the division &amp;ldquo;may pre-announce a thematic audit in an area.&amp;rdquo;[[N:Matt Fleischer-Black, &lt;a rel="noopener noreferrer" href="https://www.cslawreport.com/print_issue.thtml?uri=cyber-security-law-report/content/vol-12/no-9-mar-4-2026" target="_blank"&gt;CalPrivacy Director Discusses New Audits Division and Other 2026 Actions to Come&lt;/a&gt;, Cybersecurity L. Rep. (Mar. 4, 2026).]] Businesses can expect the division to focus on areas of recent concern to the Enforcement Division, including the frustration of consumers&amp;rsquo; exercise of their CCPA rights &amp;mdash; the rights to access, correct, delete, and opt-out of the sale and sharing of personal data &amp;mdash; and failure to comply with privacy policy requirements. In a recent panel discussion, representatives from the bipartisan Consortium of Privacy Regulators &amp;mdash; including Michael Macko, Deputy Director of Enforcement for CalPrivacy, and Stacey Schesser, Supervising Deputy Attorney General for the California Department of Justice &amp;mdash; cited other key priorities as including chatbot-related practices, surveillance pricing, the use of data in large language models, and practices surrounding sensitive data, including non-HIPAA covered health data.[[N:See &lt;a rel="noopener noreferrer" href="https://iapp.org/conference/iapp-global-summit/agenda/state-collaboration-on-privacy" target="_blank"&gt;IAPP Global Summit 2026 Conference Agenda&lt;/a&gt;, IAPP.]]&lt;/p&gt;
&lt;p&gt;Audits can be expected to include review of information about the business&amp;rsquo;s cybersecurity program, information systems, and use of service providers or contractors.[[N:See CCPA Regs. &amp;sect; 7122(b) (requiring businesses to make such information available to auditors).]] Auditors may also conduct interviews but will expect that facts relevant to the audit be based on more than attestations by business management.[[N:See id. &amp;sect; 7122(d) (explaining that audits cannot &amp;ldquo;rely primarily on assertions or attestations by the business&amp;rsquo;s management&amp;rdquo;).]]&lt;/p&gt;
&lt;h2&gt;Could These Audits Lead to Enforcement Action?&lt;/h2&gt;
&lt;p&gt;The Audits Division will complement the Enforcement Division of CalPrivacy, and businesses should understand that violations discovered by the Audits Division could be referred to the Enforcement Division.[[N:Matt Fleischer-Black, supra note 14.]]&lt;/p&gt;
&lt;p&gt;Companies referred to the Enforcement Division for noncompliance could face significant fines. Recent enforcement actions included fines ranging from &lt;a href="https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2025/05/cppa-brings-second-enforcement-action" target="_self"&gt;$345,178&lt;/a&gt; to $1.35 million.[[N:See &lt;a rel="noopener noreferrer" href="https://cppa.ca.gov/announcements/2025/20250930.html" target="_blank"&gt;Nation&amp;rsquo;s Largest Rural Lifestyle Retailer to Pay $1.35M Over CCPA Violations&lt;/a&gt;, PRIVACY.CA.GOV (Feb. 3, 2026).]] And these fines could get even higher. In the panel discussion referenced above, Deputy Director Macko commented that there may be a risk that fines under the CCPA could become the &amp;ldquo;cost of doing business,&amp;rdquo; hinting at CalPrivacy&amp;rsquo;s interest in increasing fines to ensure they maintain deterrent value. &lt;/p&gt;
&lt;h2&gt;Audits Are Here &amp;mdash; How Should You Prepare?&lt;/h2&gt;
&lt;p&gt;With these audits imminent, companies should consider immediately doing the following:&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Determine whether the cybersecurity audit regulations apply to your organization&lt;/strong&gt;. For-profit businesses &amp;ldquo;doing business in California&amp;rdquo;[[N:Cal. Civ. Code &amp;sect; 1798.140(d)(1) (defining &amp;ldquo;business&amp;rdquo; under the CCPA).]] whose processing activities present a &amp;ldquo;significant risk to consumers&amp;rsquo; privacy or security&amp;rdquo; are subject to the regulations.[[N:CCPA Regs. &amp;sect; 7120(a).]] Notably, the audit requirements are not limited to only those businesses based in California. A business presents a &amp;ldquo;significant risk&amp;rdquo; if, in the preceding calendar year, it met either of the following:&lt;/p&gt;
&lt;ul style="margin-left: 40px;"&gt;
    &lt;li&gt;Generated annual gross revenue exceeding $25 million and either (1) processed the personal information of 250,000 consumers or households, or (2) processed the sensitive personal information of 50,000 or more consumers[[N:Id. &amp;sect; 7120(a)(2).]]&lt;/li&gt;
    &lt;li&gt;Derived 50% or more of its annual revenues from selling or sharing consumers&amp;rsquo; personal information[[N:Id. &amp;sect; 7120(a)(1).]]&lt;/li&gt;
&lt;/ul&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Structure readiness work for privilege protection&lt;/strong&gt;. Cybersecurity audit documentation may be discoverable in data breach and other litigation and is not automatically covered by attorney-client privilege. Although the CCPA regulations only require that businesses produce audit certification, not production of the underlying audit reports, those reports could nonetheless be subject to subpoenas from CalPrivacy or other regulators, either before or after certification. While understanding those risks, it is also important to recognize that early documentation could be instrumental in demonstrating commitment to strong cybersecurity policies and will not only be useful in any pre-certification audits, but can also serve as the basis for later CCPA required audits.[[N:See id. &amp;sect; 7123(f) (allowing businesses to utilize prior cybersecurity audits for purposes of certification, so long as they meet all requirements).]] Companies should consider engaging outside counsel to direct the initial readiness assessment and establish a privilege framework before generating documentation.&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Confirm whether cybersecurity program ownership meets audit standards&lt;/strong&gt;. Most companies subject to the regulations will already have a cybersecurity program with designated owners. The CCPA requires that such &amp;ldquo;qualified individuals&amp;rdquo; be identified in the audit report[[N:Id. &amp;sect; 7123(e)(6).]] and companies should understand that auditors may assess whether those individuals have sufficient expertise and authority, and whether their roles, responsibilities, and reporting lines are formally documented. Companies should review their program governance against these criteria and close any gaps in documentation now.&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Evaluate substantive program components&lt;/strong&gt;. The CCPA regulations set out 18 cybersecurity program components[[N:Those 18 components can be found in &lt;a rel="noopener noreferrer" href="https://cppa.ca.gov/regulations/pdf/ccpa_updates_cyber_risk_admt_appr_text.pdf" target="_blank"&gt;Article 9 of the CCPA regulations&lt;/a&gt;, section 7123(c)(1) through (c)(18).]] that the audit may assess depending on whether the auditor deems them &amp;ldquo;applicable to the business&amp;rsquo;s information system.&amp;rdquo; However, even components outside of those 18 could be assessed by an auditor.[[N:CCPA Regs. &amp;sect; 7123(d) (&amp;ldquo;Nothing in this section prohibits a cybersecurity audit from assessing components of a cybersecurity program that are not set forth in subsections (b) or (c).&amp;rdquo;).]] Businesses should comprehensively evaluate their cybersecurity policies and controls against each component, identify gaps, and document the operation of effective controls.&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Consider whether to engage an independent auditor&lt;/strong&gt;. The CCPA regulations require businesses to retain a &amp;ldquo;qualified, objective, independent professional&amp;rdquo; auditor.[[N:Id. &amp;sect; 7122(a).]] This could be an internal or external auditor so long as they are impartial and objective.[[N:Id. &amp;sect; 7122(a)(2).]] While a formal auditor is not necessarily required at this early stage, businesses might consider identifying potential auditors now to prepare for future audit requirements.&lt;/p&gt;
&lt;p style="margin-left: 40px;"&gt;&lt;strong&gt;Coordinate readiness with Article 10 risk assessments&lt;/strong&gt;. The cybersecurity audit certification required by Article 9 is distinct from the separate risk assessment obligation under Article 10,[[N:CCPA Regs. art. 10.]] which similarly requires businesses whose processing activities present a &amp;ldquo;significant risk to consumers&amp;rsquo; privacy&amp;rdquo;[[N:CCPA Regs. &amp;sect; 7150(a). Please note, however, that the definition of &amp;ldquo;significant risk&amp;rdquo; for risk assessment purposes is different from the definition for cybersecurity audits. See id. &amp;sect; 7150(b).]] to conduct and document privacy risk assessments and to submit an annual attestation that the required assessments have been conducted.[[N:See CCPA Regs. &amp;sect; 7157.]] As with the audit regime, CalPrivacy may request the underlying risk assessments on demand.[[N:Executive Director Kemp has stated that compliance for risk assessments, &amp;ldquo;actually begins now, January 1, 2026.&amp;rdquo; The Privacy Advisor Podcast, supra note 7, at 00:21:11-00:21:42.]] Although the triggers and deliverables differ, much of the underlying readiness work (mapping processing activities, identifying controls, and documenting rationales) supports both regimes, and companies should coordinate accordingly.&lt;/p&gt;
&lt;p&gt;Organizations that have questions about conducting cybersecurity audits, or about the CCPA more generally, may contact any of the authors of this Advisory or their usual Arnold &amp;amp; Porter contact. Our &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/privacy-cybersecurity-data-strategy" target="_self"&gt;Privacy, Cybersecurity &amp;amp; Data Strategy team&lt;/a&gt; would be pleased to assist with any questions about privacy compliance and enforcement.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{1683D9B9-1BAD-4BC7-B553-4991938719EC}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-anti-corruption-spring-2026</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Siyi Gu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gu-siyi</a10:uri><a10:email>siyi.gu@cn.arnoldporter.com</a10:email></a10:author><title>China Compliance Update: Anti-Corruption — Spring 2026</title><description>&lt;p&gt;Anti-corruption continued to be a major focus for Chinese regulators in 2026, with the Supreme People&amp;rsquo;s Court publishing its first new judicial interpretations of China&amp;rsquo;s corruption and bribery regulations in a decade. Official statistics provided further evidence of regulators&amp;rsquo; continued emphasis on both administrative and criminal anti-corruption enforcement.&lt;/p&gt;</description><pubDate>Fri, 01 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;Anti-corruption continued to be a major focus for Chinese regulators in 2026, with the Supreme People&amp;rsquo;s Court publishing its first new judicial interpretations of China&amp;rsquo;s corruption and bribery regulations in a decade. Official statistics provided further evidence of regulators&amp;rsquo; continued emphasis on both administrative and criminal anti-corruption enforcement.&lt;/p&gt;
&lt;h2&gt;New Judicial Interpretation on Corruption and Bribery&lt;/h2&gt;
&lt;p&gt;On April 10, 2026, China&amp;rsquo;s Supreme People&amp;rsquo;s Court (SPC) and Supreme People&amp;rsquo;s Procuratorate (SPP) issued the &lt;a rel="noopener noreferrer" href="https://www.court.gov.cn/fabu/xiangqing/497181.html" target="_blank"&gt;Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery (II)&lt;/a&gt; (Interpretation (II), &lt;span&gt;关于&lt;/span&gt;&lt;span&gt;办理贪污贿赂刑事案件适用法律若干问题的解释（二）&lt;/span&gt;), which will come into effect on May 1, 2026. This is a significant development, with the prior interpretation of the criminal law of bribery released by the SPC and SPP in 2016. It also follows a series of other developments in China&amp;rsquo;s anti-corruption regulatory framework, including revisions to the PRC Criminal Law, Anti-Unfair Competition Law, and Supervision Law.[[N:For further analysis of the revised Supervision Law, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2026/03/china-anticorruption-2025-year-in-review" target="_self"&gt;China Anti-Corruption: 2025 Year in Review&lt;/a&gt;. For further analysis of the AUCL, see &lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/07/china-compliance-update-summer-2025" target="_self"&gt;China Compliance Update &amp;mdash; Summer 2025&lt;/a&gt;.]]&lt;/p&gt;
&lt;p&gt;The Interpretation (II) provides further clarifications of the provisions of China&amp;rsquo;s Criminal Law that relate to crimes of corruption, with a focus on crimes in the private sector and &amp;ldquo;entity crimes,&amp;rdquo; meaning crimes that carry liability for companies, public institutions, government agencies, and other organizations.&lt;/p&gt;
&lt;h2&gt;Lowered Thresholds For Non-State Functionaries&lt;/h2&gt;
&lt;p&gt;One of the key elements of the Interpretation (II) is lowering the monetary thresholds for four crimes relating to non-state functionaries, bringing the thresholds for these crimes in line with the thresholds for similar crimes relating to state functionaries. &amp;ldquo;State functionaries&amp;rdquo; is a term referring not only to government officials, but which also includes other individuals who perform public duties in state-owned enterprises and public institutions.[[N:See Article 93 of the PRC Criminal Law.]]&lt;/p&gt;
&lt;p&gt;According to Article 8 of the Interpretation (II):&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The standards for conviction and sentencing for Accepting Bribes by Non-State Functionaries (&lt;span&gt;非国家工作人&lt;/span&gt;&lt;span&gt;员受贿罪&lt;/span&gt;, Article 163) shall be the same as the standards for Accepting Bribes (&lt;span&gt;受&lt;/span&gt;&lt;span&gt;贿罪&lt;/span&gt;).[[N:The definition of &amp;ldquo;Accepting Bribes&amp;rdquo; requires that the party accepting a bribe is a state functionary.]] The monetary thresholds of this crime were previously two to five times higher than the thresholds for Accepting Bribes.&lt;/li&gt;
    &lt;li&gt;The standards for conviction and sentencing of Offering Bribes to Non-State Functionaries (&lt;span&gt;对非国家工作人员行贿罪&lt;/span&gt;, Article 164) shall be the same as the standards for Offering Bribes (&lt;span&gt;行&lt;/span&gt;&lt;span&gt;贿罪&lt;/span&gt;) and Offering Bribes by Entities (&lt;span&gt;单位行贿罪&lt;/span&gt;).[[N:The definitions for these crimes also include the requirement that the recipient of the bribes is a state functionary.]] The monetary thresholds for these crimes were originally two times higher than the thresholds for Offering Bribes.&lt;/li&gt;
    &lt;li&gt;The monetary thresholds for Embezzlement (&lt;span&gt;职务侵占罪&lt;/span&gt;, Article 271) and Misappropriation of Funds (&lt;span&gt;挪用&lt;/span&gt;&lt;span&gt;资金罪&lt;/span&gt;, Article 272) were also lowered to align with those of Corruption (&lt;span&gt;贪污罪&lt;/span&gt;) and Misappropriation of Public Funds (&lt;span&gt;挪用公款罪&lt;/span&gt;). The elements of these crimes are the same, although the latter two offenses refer to conduct by state functionaries.&lt;/li&gt;
    &lt;li&gt;Notably, Article 8 also requires a comprehensive overview of the nature and circumstances of the crimes when dealing with crimes relating to non-state functionaries, in order to ensure that the crimes, liabilities, and sentencing are proportionate.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These adjustments to the interpretation of the Criminal Law are intended to provide private companies the same level of legal protection as government agencies and state-owned enterprises, in order to ensure a positive business environment. This is consistent with recent enforcement and legislative trends for Chinese regulators.[[N:For additional analysis of recent anti-corruption enforcement trends in China&amp;rsquo;s public and private sectors, see &lt;a href="https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2026/01/china-compliance-update-december-2025" target="_self"&gt;China Compliance Update &amp;mdash; December 2025&lt;/a&gt;.]] For example, the &lt;a rel="noopener noreferrer" href="http://www.npc.gov.cn/npc/c2/c30834/202312/t20231229_433988.html" target="_blank"&gt;12th Amendment to the Criminal Law&lt;/a&gt;, which took effect on March 1, 2024, expanded the scope of application of three crimes of corruption, which previously were limited to individuals from state-owned enterprises, to include individuals from the private sector.&lt;/p&gt;
&lt;h2&gt;Revised Standards For Entity Crimes and Key Sectors&lt;/h2&gt;
&lt;p&gt;The Interpretation (II) also clarifies the judicial standards for conviction and sentencing for entity crimes relating to corruption. Article 2 of Interpretation (II) states the following regarding the crime of Offering Bribes to Entities (&lt;span&gt;对单位行贿罪&lt;/span&gt;, Article 391):&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The monetary thresholds increase from RMB 100,000 (US$14,286) to RMB 200,000 (US$28,571) for crimes committed by individuals and from RMB 200,000 (US$28,571) to RMB 400,000 (US$57,142) for crimes committed by entities.&lt;/li&gt;
    &lt;li&gt;Clarifies that the monetary thresholds for &amp;ldquo;serious conditions&amp;rdquo; under the Criminal Law are RMB 2,000,000 (US$285,714) for crimes committed by individuals and RMB 4,000,000 (US$571,428) for crimes committed by entities.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Articles 2 and 4 of the Interpretation (II) also flag multiple key sectors for which the monetary thresholds for crimes of corruption will be lowered, including finance, food and drug, social security (including the state-run medical insurance program), and healthcare, among others.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The monetary thresholds of Offering Bribes to Entities are RMB 100,000 (US$14,286) for crimes committed by individuals, and RMB 200,000 (US$28,571) for crimes committed by entities within these key sectors. The monetary thresholds in all other sectors are RMB 200,000 (US$28,571) for crimes committed by individuals, and RMB 400,000 (US$57,142) for crimes committed by entities as discussed above.&lt;/li&gt;
    &lt;li&gt;The monetary thresholds of Offering Bribes by Entities are RMB 100,000 (US$14,286) within these key sectors, while the monetary thresholds for all other sectors are RMB 200,000 (US$28,571).&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;These provisions highlight the regulators&amp;rsquo; heightened focus on these key sectors. This interpretation is also consistent with the revisions in the &lt;a rel="noopener noreferrer" href="http://www.npc.gov.cn/npc/c2/c30834/202312/t20231229_433988.html" target="_blank"&gt;12th Amendment to the Criminal Law&lt;/a&gt;, that misconduct in these key sectors will be considered as aggravating factors for the crime of Offering Bribes and subject to more severe penalties.&amp;nbsp;&lt;/p&gt;
&lt;h2&gt;Anti-Corruption Enforcement&lt;/h2&gt;
&lt;p&gt;Enforcement data published by regulators further highlighted the government&amp;rsquo;s continued focus on anti-corruption:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The SPC &lt;a rel="noopener noreferrer" href="http://lianghui.people.com.cn/2026/n1/2026/0316/c461827-40682955.html" target="_blank"&gt;reported&lt;/a&gt; on March 16, 2026 that Chinese courts nationwide adjudicated 36,000 cases (40,000 individuals) relating to duty-related crimes[[N:Duty-related crimes refer to a category of criminal charges under the PRC Criminal Law that relate to Government Officials (GO) or non-GO managerial personnel performing public duties. Duty-related crimes involve the misuse of one&amp;rsquo;s official role to engage in misconduct, including but not limited to bribery, corruption, and embezzlement.]] in 2025, representing a 22.4% year-on-year increase.&lt;/li&gt;
    &lt;li&gt;The SPP &lt;a rel="noopener noreferrer" href="http://lianghui.people.com.cn/2026/n1/2026/0316/c461827-40682956.html" target="_blank"&gt;reported&lt;/a&gt; on March 16, 2026 that in 2025, disciplinary inspection commissions at all levels transferred cases implicating 30,500 individuals to procuratorates for criminal investigation, representing at 10.8% year-on-year increase. Among these cases, 29,000 individuals were eventually prosecuted, representing a 20.5% year-on-year increase.&lt;/li&gt;
    &lt;li&gt;The Central Commission for Discipline Inspection of the Communist Party of China (CCDI) &lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/toutiaon/202604/t20260422_486590.html" target="_blank"&gt;reported&lt;/a&gt; on April 23, 2026 that in the first quarter of 2026, commissions for discipline inspection nationwide initiated 245,000 investigations into government officials for corruption-related issues.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Chinese regulators also continued to emphasize enforcement against both paying and accepting bribes, as reflected in enforcement data published by the SPC, SPP, and CCDI:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;In 2025, Chinese courts adjudicated 2,724 cases (3,235 individuals) of paying bribes, representing a 10.1% year-on-year increase. Chinese procuratorates prosecuted 3,292 individuals for paying bribes, representing a 7.3% year-on-year increase.&lt;/li&gt;
    &lt;li&gt;In the first quarter of 2026, commissions for discipline inspection nationwide initiated investigations into 9,066 individuals for paying bribes, 983 of which were transferred to procuratorates for criminal investigation.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold &amp;amp; Porter&amp;rsquo;s &lt;a href="https://www.arnoldporter.com/en/services/capabilities/practices/white-collar-defense-and-investigations" target="_self"&gt;White Collar Defense &amp;amp; Investigations&lt;/a&gt; practice group.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;* Zhewen Zhang contributed to this Blog&lt;/em&gt;.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A8C7F9C4-307F-4BD6-8641-62A1064EE81E}</guid><link>https://www.fdli.org/2026/05/how-courts-reviewed-fda-action-before-chevron-and-may-again-after-loper-brightopen-access/?utm_source=chatgpt.com</link><author>Jonathan.Trinh@arnoldporter.com</author><title>How Courts Reviewed FDA Action Before Chevron and May Again After Loper Bright</title><pubDate>Fri, 01 May 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{41B10E16-FC4E-407B-B588-6D116764DFEE}</guid><link>https://www.arnoldporter.com/en/perspectives/publications/2026/04/virtual-digital-health-digest</link><a10:author><a10:name>Allison W. Shuren</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/shuren-allison-w</a10:uri><a10:email>allison.shuren@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Alexander Roussanov</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roussanov-alexander</a10:uri><a10:email>alexander.roussanov@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Abeba Habtemariam</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/habtemariam-abeba</a10:uri><a10:email>Abeba.Habtemariam@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Dr. Beatriz San Martin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/san-martin</a10:uri><a10:email>beatriz.sanmartin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Fabien Roy</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/roy-fabien</a10:uri><a10:email>fabien.roy@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Monique Nolan, M.D., J.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nolan-monique</a10:uri><a10:email>monique.nolan@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Eleri Abreo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/abreo-eleri-f</a10:uri><a10:email>eleri.abreo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Jacqueline L. Degann</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/degann-jacqueline</a10:uri><a10:email>jackie.degann@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Casey Brouhard</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brouhard-casey</a10:uri><a10:email>casey.brouhard@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Emma Elliston, Ph.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/e/elliston-emma</a10:uri><a10:email>emma.elliston@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Ana González-Lamuño</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gonzalez-lamuno-ana</a10:uri><a10:email>ana.lamuno@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Brianna Morigney</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/morigney-brianna</a10:uri><a10:email>brianna.morigney@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katherine Rohde</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/rohde-katherine</a10:uri><a10:email>kate.rohde@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Lily Cao</a10:name><a10:uri>https://www.arnoldporter.com/en/people/c/cao-lily</a10:uri><a10:email>lily.cao@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Heba Jalil</a10:name><a10:uri>https://www.arnoldporter.com/en/people/j/jalil-heba</a10:uri><a10:email>heba.jalil@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Mickayla A. Stogsdill</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/stogsdill-mickayla</a10:uri><a10:email>mickayla.stogsdill@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Katie Brown</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/brown-katie</a10:uri><a10:email>katie.brown@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Caroline Oliver</a10:name><a10:uri>https://www.arnoldporter.com/en/people/o/oliver-caroline</a10:uri><a10:email>caroline.oliver@arnoldporter.com</a10:email></a10:author><title>Virtual &amp; Digital Health Digest</title><description>This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2026 from the United States, United Kingdom, and European Union.</description><pubDate>Fri, 01 May 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2026 from the United States, United Kingdom, and European Union.&lt;/p&gt;
&lt;h2&gt;In this issue, you will find the following:&lt;/h2&gt;
&lt;h3&gt;U.S. News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Health Care Fraud And Abuse Updates"&gt;Health Care Fraud and Abuse Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Provider Reimbursement Updates"&gt;Provider Reimbursement Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy and AI Updates"&gt;Privacy and Artificial Intelligence (AI) Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;U.S. Featured Content &lt;/h3&gt;
&lt;p&gt;This month&amp;rsquo;s edition covers a dynamic landscape at the intersection of health care compliance, technology regulation, and federal policy. On the enforcement front, two notable health care fraud cases, including a Florida pharmacy scheme and a $46 million telemedicine fraud, underscore the government&amp;rsquo;s continued focus on Medicare abuse. In the regulatory arena, the U.S. Food and Drug Administration (FDA) made headlines by rejecting a deregulatory artificial intelligence (AI) petition from Harrison.ai, reaffirming that premarket review remains essential for AI-powered radiology devices, while simultaneously seeking fresh input on digital health technologies in clinical investigations. Meanwhile, federal health agencies are pushing forward on digital health integration as the Centers for Medicare and Medicaid Services (CMS) launched its Health Tech Ecosystem initiative, introduced the ACCESS model for enhanced digital health reimbursement, and announced the LEAD accountable care model, all while the U.S. Department of Health and Human Services (HHS) restructured its health information technology (IT) offices to sharpen focus on interoperability. On Capitol Hill, lawmakers introduced a wave of AI-related legislation from Sen. Blackburn&amp;rsquo;s TRUMP AMERICA AI Act to bills addressing AI chatbots in professional services and biodata standardization, signaling that Congress is actively grappling with how to govern artificial intelligence across health care and beyond.&lt;/p&gt;
&lt;h3&gt;EU and UK News&lt;/h3&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;a href="#Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#IP Updates"&gt;IP Updates&lt;/a&gt;&lt;/li&gt;
    &lt;li&gt;&lt;a href="#Product Liability Updates"&gt;Product Liability Updates&lt;/a&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;h3&gt;EU/UK Featured Content &lt;/h3&gt;
&lt;p&gt;Regulatory activity in the EU and UK over the past month has focused on accelerating the alignment of digital, AI, and life sciences regulatory frameworks, alongside increasing scrutiny of data governance and market readiness for emerging technologies.&lt;/p&gt;
&lt;p&gt;At the EU level, work to simplify and streamline EU AI-related legislation has advanced, with the Council of the European Union and European Parliament having adopted their positions on the European Commission&amp;rsquo;s (EC) Digital Omnibus reforms, and now entering trilogue negotiations on the final text. In parallel, MedTech Europe published its response to the EC consultation on the simplification of the EU AI rules as part of the Digital Omnibus, calling for clearer integration between the AI Act and other sectoral legislation, as well as extended implementation timelines. Separately, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed European Biotech Act, emphasizing the need for clearer safeguards, harmonized legal bases for processing clinical data, and strong protections when health and genetic data are used in biotech and AI contexts.&lt;/p&gt;
&lt;p&gt;In the UK, developments have focused on the role of AI-enabled innovation within the health care system. A new parliamentary inquiry into personalized medicine and AI will examine ongoing challenges and barriers to National Health Service (NHS) adoption of new technologies, including procurement, digital infrastructure limitations, and system fragmentation. At the same time, the Medicines and Healthcare products Regulatory Agency (MHRA) has secured multi year funding to expand its AI Airlock Program to support the development of more ambitious AI medical devices. These initiatives signal a continued policy commitment to embedding digital and AI driven innovation into health care delivery and to strengthening the regulatory environment required to support safe deployment at scale.&lt;/p&gt;
&lt;h2&gt;U.S. News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Health Care Fraud And Abuse Updates"&gt;Health Care Fraud And Abuse Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/usao-sdca/pr/federal-jury-finds-mother-and-daughter-guilty-medicare-fraud-scheme-and-payment" target="_blank"&gt;Florida Mother-Daughter Duo Convicted of Health Care Fraud&lt;/a&gt;. On March 26, 2026, Cindy Justice, owner and president of PureScience Rx, a Florida pharmacy, and her daughter, Ashleigh Davis, operations manager at PureScience Rx, were convicted by a grand jury for health care fraud, payment of illegal kickbacks, and conspiracy to commit other offenses. &lt;/p&gt;
&lt;p&gt;The defendant allegedly paid a telemarketing call center to target Medicare beneficiaries and facilitate medically unnecessary prescriptions, including for drugs that were not FDA-approved or supported by medical evidence. In some instances, prescriptions were issued using stolen provider identities. The scheme resulted in Medicare paying more than $4.9 million on the fraudulent claims.&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.justice.gov/opa/pr/telemedicine-company-owner-pleads-guilty-46m-medicare-fraud-scheme" target="_blank"&gt;Telemedicine Company Owner Pleads Guilty in $46 Million Medicare Fraud Scheme&lt;/a&gt;. On March 27, 2026, Christopher Harwood, owner of telemedicine company TelevisitMD, pleaded guilty to conspiracy to commit health care fraud and wire fraud in connection with a $46.2 million Medicare scheme.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;The defendant allegedly targeted Medicare beneficiaries through aggressive telemarketing practices and paid physicians to approve orders for medically unnecessary orthotic braces and genetic tests without legitimate telehealth encounters or meaningful patient relationships. Harwood and his co-conspirators then sold the signed orders to durable medical equipment suppliers and laboratories, including entities he owned, which billed Medicare for the unnecessary items. Medicare paid approximately $17.9 million on the fraudulent claims, and Harwood personally received more than $10 million.&lt;/p&gt;
&lt;h3&gt;&lt;a name="FDA Updates"&gt;FDA Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;FDA Rejects Deregulatory AI Proposal&lt;/strong&gt;. On April 1, 2026, FDA replied to a petition submitted by Rubrum Advising on behalf of Harrison.ai. In the petition, Harrison.ai requested that FDA partially exempt certain class II radiology computer-aided detection, diagnosis, triage, and notification devices from 510(k) premarket notification requirements when manufacturers met specified conditions, including having prior 510(k) clearances and implementing post-market oversight measures. FDA formally denied the petition, concluding that it did not show that premarket review is unnecessary to assure safety and effectiveness. FDA was not persuaded by the petition&amp;rsquo;s arguments and rejected the claim that a manufacturer&amp;rsquo;s prior 510(k) clearance demonstrates &amp;ldquo;proficiency in processes&amp;rdquo; that would justify exempting future devices, noting that many other aspects of AI development may not translate across indications, modalities, or device types. FDA also stated the proposal would improperly let manufacturers determine what post-market controls are sufficient &amp;ldquo;in lieu of FDA review and clearance,&amp;rdquo; which is &amp;ldquo;neither consistent with the statute nor in the best interest of public health.&amp;rdquo; After reviewing public comments and applying the four established factors for Class II exemption, FDA found that the devices still present meaningful risks, that the characteristics necessary for safe and effective performance are not yet well established across all uses, and that changes could materially affect safety, effectiveness, or even classification. FDA acknowledged the petition&amp;rsquo;s proposals, reiterated its commitment to innovative approaches for digital health regulation, and pointed manufacturers toward Predetermined Change Control Plans as a more appropriate pathway to reduce regulatory burden while maintaining oversight.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Provider Reimbursement Updates"&gt;Provider Reimbursement Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;CMS Proposes Telehealth Waivers for New Innovation Center Models&lt;/strong&gt;. CMS continues to incorporate telehealth waivers in Innovation Center models, emphasizing that such flexibilities can promote continuity of care and support broader access for Medicare beneficiaries. Most recently, CMS proposed incorporating waivers in the Long-term Enhanced ACO Design (LEAD) Model and the Comprehensive Care for Joint Replacement Expanded (CJR-X) Model.&lt;/p&gt;
&lt;p&gt;The &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/lead" target="_blank"&gt;LEAD Model&lt;/a&gt; is a 10-year voluntary ACO model that will launch after the existing ACO model, ACO Realizing Equity, Access, and Community Health (REACH) Model concludes at the end of 2026. According to the recently published &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/files/lead-rfa.pdf" target="_blank"&gt;Request for Applications&lt;/a&gt; (RFA), the LEAD Model will incorporate a &amp;ldquo;telehealth benefit enhancement&amp;rdquo; similar to the one included in ACO REACH, in which CMS will waive the rural geographic component of originating site requirements and allow the originating site to include a beneficiary&amp;rsquo;s home. CMS also will waive the interactive telecommunications system requirement for certain asynchronous dermatology and ophthalmology telehealth services, allowing for digital images to be transmitted to a practitioner and evaluated outside of a real-time interaction.&lt;/p&gt;
&lt;p&gt;Additionally, in the fiscal year (FY) 2027 inpatient prospective payment system (IPPS) &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/04/14/2026-07203/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and" target="_blank"&gt;proposed rule&lt;/a&gt;, CMS proposed a nationwide expansion of the CJR Model, which ran from 2016 through 2024. Under the proposed mandatory CJR-X Model, hospitals would be accountable for the cost and quality of care related to lower extremity joint replacement procedures for the period beginning with hospital admission through 90 days post-discharge. Like the CJR Model, CMS proposes that the CJR-X Model will waive the rural geographic component of originating site requirements and allow the originating site to include a beneficiary&amp;rsquo;s home. Furthermore, CMS proposes to create a new set of HCPCS codes to describe evaluation and management services furnished to CJR-X beneficiaries in their home via telehealth. According to CMS, the telehealth waivers will &amp;ldquo;maximize the opportunity to improve the quality of care and efficiency for episodes of care in CJR-X.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In both the LEAD Model RFA and the FY27 IPPS proposed rule, CMS recognized that broad Medicare telehealth waivers are currently in effect, pursuant to the Consolidated Appropriations Act, 2026. But because these waivers are not permanent, CMS concluded that model-specific waivers would &amp;ldquo;guarantee&amp;rdquo; telehealth services can continue for model beneficiaries, even if the broad telehealth waivers expire.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy and AI Updates"&gt;Privacy and AI Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;Information Sought on the Use of Digital Health Technologies in Clinical Investigations&lt;/strong&gt;. On March 31, 2026, FDA issued a &lt;a rel="noopener noreferrer" href="https://www.govinfo.gov/content/pkg/FR-2026-03-31/pdf/2026-06184.pdf" target="_blank"&gt;Request for Information&lt;/a&gt; (RFI) regarding the use of digital health technologies (DHTs)[[N: &amp;ldquo;Digital Health Technologies&amp;rdquo; or &amp;ldquo;DHTs&amp;rdquo; are defined by the FDA as &amp;ldquo;systems that use computing&amp;nbsp;platforms, connectivity, software, and/or sensors for health care and related uses.&amp;rdquo;]] in clinical investigations for drugs and biological products. The FDA previously issued guidance in this area in 2023, providing recommendations on ways to facilitate the use of DHTs in clinical investigations, including using DHTs to collect data for clinical investigation endpoints (&lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2023/12/22/2023-28262/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations-guidance-for" target="_blank"&gt;2023 DHT Guidance&lt;/a&gt;). In the new RFI, the FDA explains that significant technological advancements have been made since 2023, including in sensors, such as those present in smartwatches and mobile phones, which may be customized for clinical investigations. DHTs are being designed to perform interactive clinical tests of patient functions, such as dynamometers to measure strength, apps to measure coordination and fine motor skills, and accelerometers to measure balance. In light of these developments, the agency is seeking fresh input focused on four specific questions:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;What regulatory challenges do DHT manufacturers, sponsors, or other interested parties face regarding the use of DHTs in clinical investigations of drugs and biological products?&lt;/li&gt;
    &lt;li&gt;What opportunities are there for [the FDA&amp;rsquo;s Center for Drug Evaluation and Research] and [the Center for Biologics Evaluation and Research] to support and facilitate the adoption of DHTs in clinical investigations of drugs and biological products?&lt;/li&gt;
    &lt;li&gt;What areas of guidance would support the use of DHTs in clinical investigations?&lt;/li&gt;
    &lt;li&gt;What specific DHT-related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop?&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The RFI states that information and comments received in response to these questions will inform the FDA&amp;rsquo;s development of guidance documents, as well as other FDA activities to support the appropriate use of DHTs in clinical investigations of drugs and biological products.&lt;/p&gt;
&lt;p&gt;The deadline for submitting responses to the RFI is &lt;strong&gt;June 1, 2026&lt;/strong&gt;. &lt;/p&gt;
&lt;h3&gt;&lt;a name="Policy Updates"&gt;Policy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;strong&gt;HHS Continues To Prioritize AI and Digital Health Tools Across Agency Activities&lt;/strong&gt;. HHS continues to prioritize integration of AI and digital health technologies across agencies&amp;rsquo; priorities and programming. On April 9, 2026, CMS held &amp;ldquo;Health Tech Ecosystem: Live! &lt;em&gt;First Wave Launch&lt;/em&gt;,&amp;rdquo; during which the agency highlighted digital health tools from 50 &lt;a rel="noopener noreferrer" href="https://www.cms.gov/files/document/hte-first-wave-launch-mvps.pdf" target="_blank"&gt;companies&lt;/a&gt; that have met the Minimum Viable Product requirements deadline for the &lt;a rel="noopener noreferrer" href="https://www.cms.gov/health-technology-ecosystem/categories" target="_blank"&gt;Health Tech Ecosystem&lt;/a&gt; pledge. One of the agency&amp;rsquo;s initiatives includes allowing patients to share their medical records with their providers via QR code in an effort to &amp;ldquo;Kill the Clipboard.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;Additionally, the FDA is soliciting additional information from companies interested in participating in its new &lt;a rel="noopener noreferrer" href="https://www.fda.gov/news-events/press-announcements/fda-launches-tempo-first-its-kind-digital-health-pilot-expand-access-chronic-disease-technologies" target="_blank"&gt;Technology-Enabled Meaningful Patient Outcomes pilot&lt;/a&gt; for digital health devices, which will likely inform the FDA&amp;rsquo;s approach to regulating AI. Through the pilot, FDA will exercise &amp;ldquo;appropriate&amp;rdquo; enforcement discretion with regard to some medical device regulations so that devices can receive Medicare reimbursement under CMS&amp;rsquo; &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/access" target="_blank"&gt;Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model&lt;/a&gt;, which will offer enhanced reimbursement for digital health technologies that improve clinical outcomes. On April 13, 2026, CMS announced the participation of 150 &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/access-model-accepted-applicants" target="_blank"&gt;companies&lt;/a&gt; in the upcoming launch ACCESS model and extended the deadline for applications until May 15, 2026.&lt;/p&gt;
&lt;p&gt;On March 31, 2026, CMS released a &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/lead" target="_blank"&gt;Request for Applications&lt;/a&gt; for its recently announced &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/lead" target="_blank"&gt;Long-term Enhanced ACO Design model&lt;/a&gt;, which will launch as a 10-year voluntary model beginning on January 1, 2027. The LEAD model aims to attract more providers, including independent practices and rural providers, to participate in accountable care organizations. According to the RFA, the model will incorporate the use of certified interoperable electronic health records; a telehealth benefit enhancement; and a Tech Enabler Initiative to identify opportunities to enhance patient care navigation, condition management, and connections with community-based services.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Reorganization of the Office of the National Coordinator for Health Information Technology&lt;/strong&gt;. On March 31, 2026, HHS &lt;a rel="noopener noreferrer" href="https://www.hhs.gov/press-room/hhs-health-tech-leadership-deliver-data-liquidity-affordability-ai-enabled-health-care-system.html" target="_blank"&gt;announced&lt;/a&gt; a restructuring of the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) in an effort to align a &amp;ldquo;focus on nationwide health IT interoperability and data liquidity.&amp;rdquo; Under the restructuring, ASTP/ONC will now be the Office of the National Coordinator for Health Information Technology. Additionally, the offices of the HHS Chief Technology Officer (CTO), HHS Chief Artificial Intelligence Officer (CAIO), and HHS Chief Data Officer (CDO) will be moved to the Office of the Chief Information Officer (OCIO). The &lt;a rel="noopener noreferrer" href="https://www.hhs.gov/sites/default/files/fy-2027-budget-in-brief.pdf" target="_blank"&gt;president&amp;rsquo;s FY27 budget request&lt;/a&gt; would provide $50 million in funding to ONC to prioritize advancing interoperability and coordination between health IT stakeholders, including updating payment policies. Of note, ASTP/ONC was funded at $69 million in FY26.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;CMS Delays Prior Authorization Implementation for Two Services Under WISeR Model&lt;/strong&gt;. On April 6, 2026, CMS filed a &lt;a rel="noopener noreferrer" href="https://www.federalregister.gov/documents/2026/04/06/2026-06616/medicare-program-delayed-implementation-of-certain-prior-authorization-for-select-services-for-the" target="_blank"&gt;notice&lt;/a&gt; delaying the implementation of prior authorization for two services under the &lt;a rel="noopener noreferrer" href="https://www.cms.gov/priorities/innovation/innovation-models/wiser" target="_blank"&gt;Wasteful and Inappropriate Service Reduction (WISeR) model&lt;/a&gt;, including Deep Brain Stimulation for Essential Tremor and Parkinson&amp;rsquo;s Disease and Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis.&lt;/p&gt;
&lt;p&gt;On March 27, 2026, a group of 35 House Democrats sent a &lt;a rel="noopener noreferrer" href="https://delbene.house.gov/uploadedfiles/final_fy27_wiser_repeal_-_signed_v._2.pdf" target="_blank"&gt;letter&lt;/a&gt; to House Appropriations Labor-Health and Human Services (L-HHS) Subcommittee leadership urging the subcommittee to include language in its upcoming FY27 L-HHS appropriations bill to repeal the WISeR Model and prohibit implementation of other models testing prior authorization in traditional Medicare. The lawmakers also expressed concern about incentives for the model&amp;rsquo;s contractors to deny care for Medicare beneficiaries.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Senator Marsha Blackburn Releases Discussion Draft of AI Legislative Package&lt;/strong&gt;. On March 18, 2026, Sen. Marsha Blackburn (R-TN) released a &lt;a rel="noopener noreferrer" href="https://www.blackburn.senate.gov/services/files/15AAEA28-5403-480D-8720-5E4C2D6F2A9A" target="_blank"&gt;discussion draft&lt;/a&gt; of The Republic Unifying Meritocratic Performance Advancing Machine Intelligence by Eliminating Regulatory Interstate Chaos Across American Industry (TRUMP AMERICA AI) Act. According to the &lt;a rel="noopener noreferrer" href="https://www.blackburn.senate.gov/2026/3/technology/blackburn-releases-discussion-draft-of-national-policy-framework-for-artificial-intelligence/3b3b6458-b6c7-478b-9859-374949586765" target="_blank"&gt;press release&lt;/a&gt;, the legislation is intended to codify President Trump&amp;rsquo;s December 2025 AI-related &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/presidential-actions/2025/12/eliminating-state-law-obstruction-of-national-artificial-intelligence-policy/" target="_blank"&gt;executive order&lt;/a&gt;; it does not include broad state preemption, unlike past legislative attempts to implement state preemption. Instead, the TRUMP AMERICA AI Act opts for a narrow preemption of state laws that contradict provisions in the legislation. The legislative package combines several pieces of existing bipartisan legislation sponsored or cosponsored by Sen. Blackburn, including the Kids&amp;rsquo; Online Safety Act (KOSA, &lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/senate-bill/1748" target="_blank"&gt;S. 1748&lt;/a&gt;) and the NO FAKES Act (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/senate-bill/1367" target="_blank"&gt;S. 1367&lt;/a&gt;).&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Congress Considers AI in Health Care and Biotechnology&lt;/strong&gt;. In March, Members of Congress introduced multiple bills at the intersection of AI, health care, and biotechnology, including the following:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;On March 19, 2026, Reps. Kevin Mullin (D-CA), Debbie Dingell (D-MI), Doris Matsui (D-CA), Darren Soto (D-FL), Rashida Tlaib (D-MI), Jennifer McClellan (D-VA), and Kim Schrier (D-WA) &lt;a rel="noopener noreferrer" href="https://kevinmullin.house.gov/2026/03/19/lawmakers-introduce-bill-to-stop-ai-chatbots-from-impersonating-doctors-lawyers-licensed-professionals/" target="_blank"&gt;introduced&lt;/a&gt; the CHATBOT Act (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/7985" target="_blank"&gt;H.R. 7985&lt;/a&gt;), which would prohibit AI chatbots from providing unauthorized professional advice related to &amp;ldquo;covered professions&amp;rdquo; in the health care, financial services, legal, accounting, and other industries. The bill would increase liability for AI companies whose chatbots mislead users or provide harmful guidance, including additional enforcement authority under the Federal Trade Commission.&lt;/li&gt;
    &lt;li&gt;On March 12, 2026, Sens. Todd Young (R-IN) and Ben Ray Lujan (D-NM) and Reps. Ro Khanna (D-CA) and Jay Obernolte (R-CA) &lt;a rel="noopener noreferrer" href="https://www.young.senate.gov/newsroom/press-releases/young-colleagues-introduce-bill-to-ensure-american-leadership-in-ai-and-biotech/" target="_blank"&gt;introduced&lt;/a&gt; the AI-Ready Bio-Data Standards Act (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/senate-bill/4069" target="_blank"&gt;S. 4069&lt;/a&gt;/&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/7907" target="_blank"&gt;H.R. 7907&lt;/a&gt;). The legislation would direct the National Institute of Standards and Technology to create a national framework for standardizing biological datasets. Additionally, the bill would codify shared priorities of the National Security Commission on Emerging Biotechnology and the Trump administration&amp;rsquo;s &lt;a rel="noopener noreferrer" href="https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf" target="_blank"&gt;AI Action Plan&lt;/a&gt;, including investing in AI-enabled biosecurity and building datasets for genomic sequencing.&lt;/li&gt;
    &lt;li&gt;On March 4, 2026, Reps. Obernolte, Khanna, Rich McCormick (R-GA), and Jake Auchincloss (D-MA) &lt;a rel="noopener noreferrer" href="https://obernolte.house.gov/media/press-releases/obernolte-khanna-mccormick-auchincloss-introduce-bipartisan-cloud-lab-act" target="_blank"&gt;introduced&lt;/a&gt; the Cloud Labs to Advance Biotechnology (LAB) Act (&lt;a rel="noopener noreferrer" href="https://www.congress.gov/bill/119th-congress/house-bill/7801" target="_blank"&gt;H.R. 7801&lt;/a&gt;), which would direct the National Science Foundation to establish a national network of advanced, cloud-enabled laboratories to generate high-quality biological data through AI.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;EU and UK News&lt;/h2&gt;
&lt;h3&gt;&lt;a name="Regulatory Updates"&gt;Regulatory Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a href="https://assets.publishing.service.gov.uk/media/69c6aa9878ca1aa5a63609f5/COM_2025_1023_EU_MDR_EU_IVDR_Explanatory_Memorandum.pdf"&gt;UK Government Publishes Explanatory Memorandum on Proposed EU MDR and IVDR Reforms&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The UK government&amp;rsquo;s Department of Health and Social Care has published a memorandum explaining the European Commission&amp;rsquo;s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The memorandum notes that compliance with the current regulations involves high and often disproportionate compliance costs and delays, in part due to regulatory complexity. It explains that the proposed reforms aim to streamline processes, support innovation, and ensure smoother market functioning. Under the EC&amp;rsquo;s proposal, certain software-based devices will move to a lower risk class, meaning less stringent standards will apply, and it will become easier for manufacturers to seek authorization to implement planned and regular changes to software. Obligations of manufacturers of AI-based devices, where such devices are classified as high-risk under the EU AI Act, will also be reduced. The memorandum touches on UK aspects of the reforms, noting that the MDR and IVDR will apply in Northern Ireland via the Windsor Framework. It confirms that, currently, CE marked devices will be recognized in Great Britain without additional checks until June 2030 (though indefinite recognition is currently the subject of public consultation, as we have previously reported on).&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/nhs-patients-and-british-businesses-to-benefit-from-historic-changes-to-medicines-access-following-pharmaceutical-partnership-with-usa" target="_blank"&gt;New UK-U.S. Pharmaceutical Arrangement Includes MedTech&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. On April 2, 2026, the UK and U.S. finalized the &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/publications/uk-us-arrangement-on-pharmaceutical-trade-and-pricing/arrangement-between-the-united-states-of-america-and-the-united-kingdom-on-pharmaceutical-pricing-html#iv--promoting-mutually-beneficial-trade-and-investment-between-the-united-states-and-the-united-kingdom" target="_blank"&gt;landmark pharmaceutical partnership&lt;/a&gt; announced in December, which aims to give NHS patients faster access to innovative medicines while making the UK the first country in the world to secure zero tariff access for its pharmaceutical exports to the U.S. for at least three years. It has been confirmed that no additional U.S. tariffs will apply to UK HealthTech products for at least three years, providing welcome certainty for manufacturers. However, a notable imbalance remains, with HealthTech exports still subject to a 10% tariff, compared with the new zero tariff treatment for pharmaceuticals. Industry groups have stated they will continue to press officials on both sides of the Atlantic to address this discrepancy. Building on this agreement, the MHRA and FDA have also announced a &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/uk-and-us-deepen-regulatory-cooperation-on-medical-devices-building-on-wider-pharmaceutical-partnership" target="_blank"&gt;deepening of regulatory cooperation&lt;/a&gt; on medical devices, including exploring future mutual recognition mechanisms to reduce duplication, streamline approval pathways, and accelerate access to safe, cutting edge medical technologies for patients in both countries, while maintaining independent, world class safety standards. &lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdf" target="_blank"&gt;Team-NB Publishes Position Paper on Revisions of the EU Medical Devices and In Vitro Diagnostics Regulations&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. On March 2, 2026, Team-NB (the European association of notified bodies) published a position paper on the EC proposals to amend the MDR and the In Vitro Diagnostic Regulation 2017/746 (see our &lt;a href="/en/perspectives/advisories/2026/02/the-eu-medical-device-shake-up"&gt;February 2026 Advisory&lt;/a&gt;&amp;nbsp;for details on the proposals). Team-NB supports certain of the proposed measures, including increased digitalization (e.g., electronic documentation and labeling), earlier regulatory dialogue, and measures to support innovation (e.g., regulatory sandboxes for innovative technologies and combined studies). However, it identifies several concerns, in particular, reduced regulatory scrutiny (e.g., extended expiry dates) and implementation challenges in light of multiple ongoing regulatory initiatives. The position paper contributes to the ongoing legislative discussions on the revision of the MDR and IVDR.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.consilium.europa.eu/en/press/press-releases/2026/03/13/council-agrees-position-to-streamline-rules-on-artificial-intelligence/?utm_source=brevo&amp;amp;utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&amp;amp;utm_medium=email&amp;amp;utm_id=3318" target="_blank"&gt;Council of the European Union&lt;/a&gt; (Council) and &lt;a rel="noopener noreferrer" href="https://www.europarl.europa.eu/news/en/press-room/20260323IPR38829/artificial-intelligence-act-delayed-application-ban-on-nudifier-apps" target="_blank"&gt;European Parliament&lt;/a&gt; Each Adopt Their Position on the European Commission Proposal to Simplify the EU AI Rules&lt;/strong&gt;&lt;/span&gt;. The proposal, part of the EU&amp;rsquo;s Digital Omnibus package, is aimed at simplifying the implementation of harmonized rules on AI under the EU AI Act. Both the EC and the European Parliament propose amendments to streamline various requirements, reduce administrative burdens, and provide more proportionate application of AI rules across EU Member States. Both institutes support the introduction of fixed application dates for high-risk AI tools: December 2, 2027, for standalone high-risk systems and August 2, 2028, for high-risk systems embedded in products subject to EU sectoral legislation. The EC&amp;rsquo;s position reinstates key compliance safeguards, including mandatory registration of AI systems deemed exempt from high-risk classification and the strict necessity standard for processing sensitive data for bias detection. The Council also requires the EC to issue guidance to support operators of high-risk AI systems in meeting their obligations while minimizing compliance burdens. The European Parliament favors a lighter application of AI Act obligations for products already regulated under sectoral laws (e.g., for medical devices). Interinstitutional negotiations between the European Parliament, the Council, and the European Commission (&amp;ldquo;trilogue negotiations&amp;rdquo;) will now commence to agree on the final form of the law.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/mhra-expands-ai-airlock-programme-with-a-36-million-funding-boost-over-three-years?utm_medium=email&amp;amp;utm_campaign=govuk-notifications-topic&amp;amp;utm_source=5edf5538-ec86-4e51-8e09-d301ffa741e0&amp;amp;utm_content=daily" target="_blank"&gt;UK MHRA Expands AI Airlock Program&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The MHRA has secured a &amp;pound;3.6 million funding uplift to expand its AI Airlock program, the UK&amp;rsquo;s first regulatory sandbox for AI as a medical device. Since its launch in 2024, the program has identified several areas where AI medical devices raise new regulatory challenges. Following the completion of its second phase, the Department of Health and Social Care has committed &amp;pound;1.2 million per year over the next three years (2026-2029), allowing the program to move beyond the constraints of annual budgeting. This will enable the program to support more ambitious, longer-term testing models and strengthen the development of sustainable regulatory pathways for future AI medical technologies. &lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://committees.parliament.uk/work/9659/innovation-in-the-nhs-personalised-medicine-and-ai/news/212387/innovation-in-the-nhs-personalised-medicine-and-ai-inquiry-launched/" target="_blank"&gt;UK Parliament Launches Inquiry Into NHS Personalized Medicine and AI Innovation&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The House of Lords Science and Technology Committee has opened an inquiry into innovation in the NHS, using personalized medicine and AI as case studies to understand why the health service struggles to adopt cutting-edge life sciences technologies. The inquiry will examine the scientific and technological foundations of personalized medicine, including developments in genomics, biotechnology, and AI-driven analytics, and will explore the research infrastructure needed to support their development and validation. It will assess gaps between early-stage research, clinical trials, and NHS-wide delivery, including procurement challenges, clinical pathway constraints, interoperability bottlenecks, and the role of regulators and clinical bodies. The committee will also consider whether regulatory and appraisal frameworks are appropriate and proportionate for AI-based and personalized technologies, as well as how NHS structural fragmentation contributes to uneven adoption. In addition, the inquiry will explore issues including the high cost of personalized treatments, the clinical academic workforce, and clinical trials infrastructure needed for rapid implementation across the NHS.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.medtecheurope.org/resource-library/medtech-europes-response-to-the-public-consultation-on-the-digital-omnibus/" target="_blank"&gt;MedTech Europe Publishes Position Paper on the EC&amp;rsquo;s Proposal to Simplify the EU AI Rules&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The position paper was submitted in response to the EC consultation on the Digital Omnibus package. While MedTech Europe supports the European Commission&amp;rsquo;s objective of improving regulatory coherence and simplifying EU digital legislation, it calls for greater clarity and targeted adjustments to ensure that the framework functions effectively for the medical technology sector. In particular, MedTech Europe calls for: (1) greater alignment with the MDR and the IVDR in relation to risk management, ensuring that AI related obligations do not duplicate or conflict with existing sector specific frameworks; (2) explicit confirmation that investigational devices under the MDR and devices used in performance studies under the IVDR are not considered &amp;ldquo;placed on the market&amp;rdquo; or &amp;ldquo;put into service&amp;rdquo; under the AI Act, to avoid such devices being subject to AI Act obligations; (3) a harmonized designation pathway for notified bodies, covering both the AI Act and sectoral medical device legislation; and (4) a longer transition period for the application of high-risk AI system obligations, extending the implementation timeline to two years, to allow sufficient time for the development of standards and guidance, and notified body capacity necessary for effective compliance. &lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/news/faster-care-for-patients-less-admin-for-nhs-staff-and-new-ai-skills-for-key-industries-as-barnsley-tech-town-takes-next-big-step" target="_blank"&gt;UK Government Launches AI Pilots in Barnsley&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The UK government has launched two AI pilot schemes in Barnsley, making it the UK&amp;rsquo;s first &amp;ldquo;tech town.&amp;rdquo; The schemes are aimed at improving NHS services and strengthening local AI and digital capacity. The first pilot centers on an &amp;pound;800,000 AI Upskilling Challenge Fund to provide targeted AI training to small- and medium-sized enterprises and residents who may lack digital confidence, with organizations invited to pitch for funding to deliver the training. The second pilot establishes a &amp;ldquo;Healthcare Living Lab&amp;rdquo; at Barnsley Hospital NHS Foundation Trust, to trial AI tools designed to cut waiting lists, reduce missed appointments, support clinical decision‑making, and ease administrative pressures on NHS staff. The initiatives are intended to form a blueprint for wider national adoption and are intended to reflect the government&amp;rsquo;s commitment to ensuring that the benefits of AI reach local communities and key industries across the UK.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Privacy Updates"&gt;Privacy Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.edpb.europa.eu/our-work-tools/our-documents/edpbedps-joint-opinion/edpb-edps-joint-opinion-32026-proposal-european_en" target="_blank"&gt;European Data Protection Board and European Data Protection Supervisor Issue Joint Opinion 3/2026 on the European Commission Proposal for a Biotech Act&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. While the EDPB and EDPS broadly support the objectives of the EC proposal, they identify significant data protection concerns. In particular, they welcome the introduction of a harmonized legal basis under the General Data Protection Regulation (EU) 2016/679 (GDPR) for processing clinical trial data, which is intended to reduce fragmentation across EU Member States, but call for greater clarity on the scope and application of the legal basis, including more detailed protocol-level documentation, and clearer conditions for the further use of clinical trial data for scientific research.&lt;/p&gt;
&lt;p&gt;The EDPB and EDPS also highlight important uncertainties around the allocation of controller roles between sponsors and investigators, and the scope of long-term data retention requirements. They further emphasize that, while regulatory sandboxes may allow for derogations from EU clinical trial requirements, this does not alter the application of existing obligations under the GDPR. The same applies to AI use and biotech data initiatives, which should be accompanied by appropriate safeguards, particularly where health and genetic data are involved. While non-binding, the Joint Opinion is expected to carry significant weight in the legislative negotiations. Find more details on the Joint Opinion in our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/03/edpb-edps-joint-opinion-on-the-european-biotech-act-proposal-key-data-protection-implications-for-pharma-and-life-sciences/" target="_blank"&gt;March 2026 BioSlice Blog&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://health.ec.europa.eu/latest-updates/frequently-asked-questions-european-health-data-space-2026-03-26_en" target="_blank"&gt;European Commission Publishes FAQ Guidance on EHDS Regulation Implementation&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The EC has published guidance on frequently asked questions on the European Health Data Space (EHDS). The guidance explains that the aims of Regulation (EU) 2025/327 (EHDS Regulation) are to allow patients to have greater control over their health data, ensure secure cross border data sharing, and support health care delivery. The guidance also covers the relationship of the EHDS regulation with other areas of EU law, such as data protection, medical devices, and clinical trials.&lt;/p&gt;
&lt;h3&gt;&lt;a name="IP Updates"&gt;IP Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;EU and UK Copyright and AI Policy Developments. Following the UK government&amp;rsquo;s consultation on copyright and AI, which we reported on in our January 2025 Digest, the House of Lords Communications and Digital Committee published its report on March 6, 2026, followed by the UK government&amp;rsquo;s report and impact statement on March 18, 2026. At the EU level, the European Parliament adopted the &amp;ldquo;Voss Report&amp;rdquo; on March 10, 2026. Although the copyright and AI landscape remains largely unchanged with no immediate reform to copyright law, there are some notable takeaways:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Text and data mining exception: The UK government confirmed that a broad commercial text and data mining exception with an opt-out mechanism is no longer its preferred option and intends to gather further evidence before a final position is reached.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Licensing models: A licensing-first approach draws consistent support across the EU and the UK, with the Lords Report recommending a model focused on consent and fair remuneration and the Voss Report calling for a sector-based voluntary licensing process.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Transparency: The Lords Report proposes a mandatory transparency framework with granular disclosures on training data enforced by a designated regulator. Meanwhile, the Voss Report advocates itemized lists of all copyrighted works used in training, regardless of the place of training.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Labeling: There is cross-jurisdictional consensus that AI developers, service providers, and platforms should be legally required to label wholly AI-generated content.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Life sciences sector: The UK government expressly referenced the option of a focused exception for science and research to facilitate AI-driven research and accelerate drug discovery.&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;The copyright and AI landscape await more definitive policy direction.&lt;/p&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;&lt;a rel="noopener noreferrer" href="https://www.search-for-intellectual-property.service.gov.uk/GB2583455/documents" target="_blank"&gt;Fresh Doubts Over Patentability of AI-related Inventions in the UK&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. On March 27, 2026, the UK Intellectual Property Office (UKIPO) published an &lt;a rel="noopener noreferrer" href="https://www.search-for-intellectual-property.service.gov.uk/GB2583455/documents" target="_blank"&gt;Examination Report&lt;/a&gt; in relation to the patent application (GB2583455) that was the subject of the Supreme Court judgment in &lt;em&gt;Emotional Perception AI Limited v. Comptroller General of Patents, Designs and Trade Marks&lt;/em&gt; [2026] UKSC 3, as covered in our &lt;a rel="noopener noreferrer" href="https://www.biosliceblog.com/2026/04/virtual-and-digital-health-digest-february-2026/" target="_blank"&gt;February 2026 Digest&lt;/a&gt;. The report confirms that the UKIPO will fully re-examine patentability, and expressed concerns over the application of the &amp;ldquo;intermediate step,&amp;rdquo; particularly in the analysis of &amp;ldquo;mixed-type inventions.&amp;rdquo; In its assessment that the invention lacks the necessary technical character and inventive step, the report casts new doubt on the UK&amp;rsquo;s approach to patentability of AI-related and computer-implemented inventions. The applicant, Emotional Perception AI Limited, has until April 27, 2026 to provide its reply.&lt;/p&gt;
&lt;h3&gt;&lt;a name="Product Liability Updates"&gt;Product Liability Updates&lt;/a&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style="text-decoration: underline;"&gt;&lt;strong&gt;UK Government Launches Consultations on &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/consultations/product-regulation-the-uks-new-product-safety-framework/the-uks-new-product-safety-framework" target="_blank"&gt;New Product Safety Framework&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.gov.uk/government/consultations/product-regulation-market-surveillance-and-enforcement-framework/the-uks-new-core-product-regulation-market-surveillance-and-enforcement-framework" target="_blank"&gt;Market Surveillance Rules&lt;/a&gt;&lt;/strong&gt;&lt;/span&gt;. The UK government has launched two consultations on reforms to the product safety regime, with a strong emphasis on addressing risks arising from digital and AI‑enabled technologies. The first consultation sets out proposals for a new, modernized product safety framework, designed to ensure regulation keeps pace with increasingly complex digital products and connected devices. It highlights that traditional safety models are no longer adequate for technologies featuring software updates, connectivity, data driven functionality, or AI enabled behavior, and invites views on how the regime should identify and manage novel harms linked to digital features and AI enabled products. The second consultation focuses on strengthening the UK&amp;rsquo;s market surveillance and enforcement framework, proposing to consolidate dispersed enforcement powers into a single statutory instrument, introduce civil monetary penalties as an alternative to criminal prosecution, and ensure regulators have the tools needed to respond effectively to the challenges of digital supply chains and online marketplaces. Both consultations are open until June 23, 2026, and feedback can be submitted for the new &lt;a rel="noopener noreferrer" href="https://ditresearch.eu.qualtrics.com/jfe/form/SV_b9DVcTjEyjYMtIq" target="_blank"&gt;product safety framework&lt;/a&gt; and for the &lt;a rel="noopener noreferrer" href="https://ditresearch.eu.qualtrics.com/jfe/form/SV_2sj9KKWh8lX1L9A" target="_blank"&gt;market surveillance and enforcement consultation&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&lt;em&gt;Amalia White is employed as a trainee solicitor at Arnold &amp;amp; Porter&amp;rsquo;s London office. Amalia is not admitted to the practice of law.&lt;br /&gt;
Jack Chisem is employed as a paralegal at Arnold &amp;amp; Porter&amp;rsquo;s London office. Jack is not admitted to the practice of law.&lt;br /&gt;
&lt;/em&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: small;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{D7DC4B67-163B-4C97-AA81-1931E0951121}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/04/deal-to-dispute-managing-risk-in-ma-and-commercial-transactions</link><a10:author><a10:name>Randall H. Miller</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/miller-randall-h</a10:uri><a10:email>randy.miller@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Carmela T. Romeo</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/romeo-carmela-t</a10:uri><a10:email>carmela.romeo@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Angela R. Vicari</a10:name><a10:uri>https://www.arnoldporter.com/en/people/v/vicari-angela-r</a10:uri><a10:email>angela.vicari@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>David J. Weiner</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/weiner-david-j</a10:uri><a10:email>david.weiner@arnoldporter.com</a10:email></a10:author><title>Deal to Dispute: Managing Risk in M&amp;A and Commercial Transactions</title><description>We invite you to join us for a practical webinar on managing litigation risk in commercial transactions.</description><pubDate>Thu, 30 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;We invite you to join us for a practical webinar on managing litigation risk in commercial transactions. Our partners will explore common sources of post-signing and post-closing disputes, including:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Earn-outs, milestone provisions, and other contingent payment structures&lt;/li&gt;
    &lt;li&gt;Damages limitations and how they are applied across jurisdictions&lt;/li&gt;
    &lt;li&gt;Pre-judgment interest considerations&lt;/li&gt;
    &lt;li&gt;Lessons from recent case law developments&lt;/li&gt;
    &lt;li&gt;Enforceability of letters of intent and other preliminary agreements&lt;/li&gt;
    &lt;li&gt;Representations and warranties, and fraud-related claims&lt;/li&gt;
    &lt;li&gt;Assignment pitfalls in asset transfers and commercial contracts&lt;/li&gt;
    &lt;li&gt;Emerging risks arising from business-side use of generative AI tools in commercial decision-making&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;This program is designed for in-house counsel, litigators, corporate and transactional attorneys, compliance professionals, and business leaders involved in structuring, negotiating, overseeing, or litigating commercial transactions.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{A4BA00E1-C0E5-4AF6-85B9-0A310FAC58D8}</guid><link>https://www.arnoldporter.com/en/perspectives/events/2026/04/beyond-the-basics-mortgage-lending-secured-by-leaseholds-condominiums-and-complex-collateral</link><a10:author><a10:name>Kari L. Larson</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/larson-kari-l</a10:uri><a10:email>Kari.Larson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christian Scarlett</a10:name><a10:uri>https://www.arnoldporter.com/en/people/s/scarlett-christian</a10:uri><a10:email>christian.scarlett@arnoldporter.com</a10:email></a10:author><title>Beyond the Basics: Mortgage Lending Secured by Leaseholds, Condominiums and Complex Collateral</title><description>Arnold &amp;amp; Porter partner Kari Larson and counsel Christian Scarlett will be presenting at the 38th Annual RPTE National CLE Conference.</description><pubDate>Thu, 30 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter partner Kari Larson and counsel Christian Scarlett will be presenting at the &lt;a rel="noopener noreferrer" href="https://rptecleconference.com/" target="_blank"&gt;38th Annual RPTE National CLE Conference&lt;/a&gt; on &amp;ldquo;Beyond the Basics: Mortgage Lending Secured by Leaseholds, Condominiums and Complex Collateral.&amp;rdquo; This session will examine diligence, underwriting, and loan documentation considerations in mortgage lending involving unique asset classes and property interests, including hospitality, data centers, senior housing, ground leaseholds, and condominiums. Attendees will gain practical insights into identifying key risks, conducting effective diligence, and applying best practices in loan documentation to enhance deal certainty when closing complex transactions.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{2F6E4281-7E3B-4351-BBC1-566D87E8A14F}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/04/lacca-recognizes-arnold-porter-as-a-top-international-law-firm-for-latin-americas-largest-banks</link><title>LACCA Recognizes Arnold &amp; Porter as a Top International Law Firm for Latin America’s Largest Banks</title><description>Arnold &amp;amp; Porter was recognized as a top international law firm for Latin America's largest banks in &lt;em&gt;Latin American Corporate Counsel Association&lt;/em&gt; (&lt;em&gt;LACCA&lt;/em&gt;)'s latest research into &amp;ldquo;Who represents Latin America's biggest banks?&amp;rdquo; &lt;em&gt;LACCA&lt;/em&gt;'s report presents the &amp;ldquo;banks that make up this year&amp;rsquo;s top 100 &amp;ndash; as well as their preferred external counsel.&amp;ldquo;</description><pubDate>Thu, 30 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Arnold &amp;amp; Porter was recognized as a top international law firm for Latin America's largest banks in &lt;em&gt;Latin American Corporate Counsel Association&lt;/em&gt; (&lt;em&gt;LACCA&lt;/em&gt;)'s latest research into &amp;ldquo;Who represents Latin America's biggest banks?&amp;rdquo; &lt;em&gt;LACCA&lt;/em&gt;'s report presents the &amp;ldquo;banks that make up this year&amp;rsquo;s top 100 &amp;ndash; as well as their preferred external counsel.&amp;ldquo;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;LACCA&lt;/em&gt; highlighted the firm's recent work advising ten of Latin America&amp;rsquo;s largest banks across Brazil, Costa Rica, Mexico, Panama, and Peru. The recognition demonstrates the firm's commitment to providing strategic counsel for some of Latin America's most significant financial institutions.&lt;/p&gt;
&lt;p&gt;The firm&amp;rsquo;s Corporate &amp;amp; Finance team has handled cutting-edge transactional work and represented numerous private-sector corporations, financial institutions, and individuals in a broad range of transactions across Latin America, work complemented by Arnold &amp;amp; Porter&amp;rsquo;s leading international disputes practice and renowned regulatory experience.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{0FA2D11E-FEC7-49CE-8E9F-45C68C922E4F}</guid><link>https://www.arnoldporter.com/en/perspectives/media-mentions/2026/04/forbes-highlights-arnold-porter-on-tariff-refund-litigation-and-consumer-class-actions</link><title>Forbes Highlights Arnold &amp; Porter on Tariff Refund Litigation and Consumer Class Actions</title><description>Lori Leskin, head of Arnold &amp;amp; Porter&amp;rsquo;s consumer products practice, was quoted in the &lt;em&gt;Forbes&lt;/em&gt; article, &amp;ldquo;Consumers Won&amp;rsquo;t See Tariff Refunds. Smart Retailers Will Turn Them Into Price Cuts,&amp;rdquo; examining the legal and business implications of $166 billion in tariff refunds owed to U.S. importers following a Supreme Court ruling invalidating Trump-era tariffs.</description><pubDate>Thu, 30 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Lori Leskin, head of Arnold &amp;amp; Porter&amp;rsquo;s consumer products practice, was quoted in the &lt;em&gt;Forbes&lt;/em&gt; article, &amp;ldquo;Consumers Won&amp;rsquo;t See Tariff Refunds. Smart Retailers Will Turn Them Into Price Cuts,&amp;rdquo; examining the legal and business implications of $166 billion in tariff refunds owed to U.S. importers following a Supreme Court ruling invalidating Trump-era tariffs.&lt;/p&gt;
&lt;p&gt;Lori emphasized the growing legal and reputational risks for businesses navigating tariff refunds, as well as increasing pressure from consumers demanding price relief. However, she noted that consumers seeking relief through class actions may face significant hurdles in proving their claims. She explained that plaintiffs will struggle to establish a consistent link between tariffs and price increases, given the wide variation in how companies absorbed or passed on tariff costs. &amp;ldquo;Every company has eaten the impact of the tariff situation differently,&amp;rdquo; Lori said. &amp;ldquo;There&amp;rsquo;s so many things that explain why prices go up, that it&amp;rsquo;s going to be very hard for a consumer to be able to establish consistency across an entirety of a class.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;The article also quotes from the Arnold &amp;amp; Porter advisory, &amp;ldquo;&lt;a href="/en/perspectives/advisories/2026/03/the-next-wave-of-tariff-litigation"&gt;The Next Wave of Tariff Litigation: Consumer Class Actions&lt;/a&gt;,&amp;rdquo; which was authored by Lori, Brandon Neuschafer, and Elie Salamon, highlighting the expanding scope of potential litigation and warning that manufacturers, distributors, and logistics companies &amp;mdash; not just retailers &amp;mdash; could face exposure. &amp;ldquo;The initial wave of consumer class action complaints demonstrates that plaintiffs are not limiting their theories to explicit tariff line-items. The broader argument &amp;mdash; that any company that passed through tariff costs must return corresponding refunds &amp;mdash; has potentially sweeping implications for businesses.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;a rel="noopener noreferrer" href="https://www.forbes.com/sites/pamdanziger/2026/04/29/consumers-wont-see-tariff-refunds-smart-retailers-will-turn-them-into-price-cuts/" target="_blank"&gt;Read the full article&lt;/a&gt;. &lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{576BF98B-3430-4C78-ACCB-6E49BBF98872}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/china-compliance-update-life-sciences-spring-2026</link><a10:author><a10:name>John Tan</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/tan-john</a10:uri><a10:email>john.tan@cn.arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Siyi Gu</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gu-siyi</a10:uri><a10:email>siyi.gu@cn.arnoldporter.com</a10:email></a10:author><title>China Compliance Update: Life Sciences — Spring 2026</title><description>In 2026, Chinese regulators have continued their focus on anti-corruption enforcement in the life sciences industry. In addition to long-standing priorities, such as fraud against China&amp;rsquo;s state-run medical insurance program, regulators appear to be paying greater attention to investigator-initiated studies and patient programs in 2026. This Advisory summarizes recent regulatory developments and enforcement actions.</description><pubDate>Thu, 30 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;In 2026, Chinese regulators have continued their focus on anti-corruption enforcement in the life sciences industry. In addition to long-standing priorities, such as fraud against China&amp;rsquo;s state-run medical insurance program, regulators appear to be paying greater attention to investigator-initiated studies and patient programs in 2026. This Advisory summarizes recent regulatory developments and enforcement actions.&lt;/p&gt;
&lt;h2&gt;Medical Insurance Fraud: Enforcement and Regulatory Developments&lt;/h2&gt;
&lt;p&gt;Statistics issued by Chinese regulators in 2026 show that fraud against the state-run medical insurance program remained a primary focus of both administrative and criminal enforcement:[[N:&amp;nbsp;For further analysis of enforcement actions targeting medical insurance fraud in 2025, see C&lt;a href="/en/perspectives/advisories/2025/09/chinese-regulators-enforcement-against-medical-insurance-fraud"&gt;hinese Regulators Continue Enforcement Actions Against Medical Insurance Fraud&lt;/a&gt;.]]&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;The National Healthcare Security Administration (NHSA), which is responsible for the state-run medical insurance program, &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/3/16/art_7_19918.html" target="_blank"&gt;reported&lt;/a&gt; on March 16, 2026 that 3,776 cases involving medical insurance were jointly investigated by the NHSA and police, and 10,357 criminal suspects were arrested. In addition, 1,626 entities (e.g., hospitals and pharmacies) were verified to have engaged in medical insurance fraud, and a total of RMB 34.2 billion (US$4.75 billion) of medical insurance funds were recovered.&lt;/li&gt;
    &lt;li&gt;The Supreme People&amp;rsquo;s Court (SPC) reported that a total of 1,433 criminal cases relating to medical insurance fraud were adjudicated in 2025. These cases implicated 2,807 individuals and represented a year-on-year increase of 24%.&lt;/li&gt;
    &lt;li&gt;The Supreme People&amp;rsquo;s Procuratorate (SPP) reported that a total of 5,256 individuals were prosecuted in 2025 for crimes relating to the state-run medical and social insurance programs.&amp;nbsp;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;In February, the NHSA published the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/2/13/art_173_19681.html" target="_blank"&gt;Implementing Rules on the Regulations on Supervising and Administering the Use of Medical Insurance Funds&lt;/a&gt; (Implementing Rules, 医疗保障基金使用监督管理条例实施细则), which came into effect on April 1, 2026. The Implementing Rules clarified the requirements of the &lt;a rel="noopener noreferrer" href="https://www.gov.cn/gongbao/content/2021/content_5591403.htm" target="_blank"&gt;Regulations on Supervising and Administering the Use of Medical Insurance Funds&lt;/a&gt; (Regulations, 医疗保障基金使用监督管理条例), which came into effect on May 1, 2021, providing detailed procedures and guidelines for regulators to carry out enforcement actions. Like the Regulations, the Implementing Rules focus on potential misconduct by individuals and institutions who utilize state-run medical insurance funds, such as patients, hospitals, and pharmacies. &lt;/p&gt;
&lt;p&gt;Also in February, the NHSA released the &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/2/2/art_104_19556.html" target="_blank"&gt;Notice on Strengthening the Supervision of Medical Insurance Funds in 2026&lt;/a&gt; (Notice, 国家医疗保障局关于做好2026年医疗保障基金监管工作的通知), which sets forth an array of regulatory approaches for tackling misconduct relating to medical insurance. The Notice discusses multiple measures to reduce medical insurance fraud, including enhancing the use of electronic tracking systems (such as UIDs) to prevent the illegal resale of products purchased with medical insurance funds, and strengthening unannounced inspections of the use of medical insurance funds. The NHSA also published case studies of unannounced inspections, which will be discussed in detail below.[[N: These unannounced inspections are carried out by the NHSA and provincial healthcare security administrations, and target healthcare institutions, medical insurance administrations, and other agencies providing medical insurance services. Issues identified during the inspections may result in administrative penalties, and may be transferred to other regulators, such as disciplinary inspection commissions, for further action.]]&lt;/p&gt;
&lt;h2&gt;Corporate Liability and Cooperation Credit&lt;/h2&gt;
&lt;p&gt;In March and April, the NHSA published several case studies of enforcement actions relating to bribery in the health care industry. Although some of the cases showed fact patterns familiar from prior NHSA case studies, such as manufacturers&amp;rsquo; sales representatives or distributors&amp;rsquo; personnel paying kickbacks to HCPs in return for sales and collection of HCPs&amp;rsquo; prescription data, a few points stood out:[[N: For further analysis of enforcement cases published by the NHSA in January 2026, see &lt;a href="/en/perspectives/advisories/2026/03/china-life-sciences-2025-year-in-review"&gt;China Life Sciences: 2025 Year in Review&lt;/a&gt;.]]&lt;/p&gt;
&lt;p&gt;In one case, a distributor was fined RMB 250,000 (US$35,714) for bribery by an entity after its actual controller was found to have paid kickbacks to multiple HCPs at two hospitals. This may signal an increased focus by Chinese regulators on bringing charges against corporations. &lt;/p&gt;
&lt;p&gt;In a second case, the NHSA noted that although two pharmaceutical manufacturers were both found to have paid bribes to an HCP, the companies&amp;rsquo; level of cooperation affected their penalties. Both companies had &amp;ldquo;credit evaluations&amp;rdquo; performed by the Qinghai Health Security Administration. One company proactively corrected its misconduct and remedied the negative impact of its misconduct before its credit evaluation was finalized and therefore did not receive any penalty. The second company failed to take remedial action, received a credit evaluation result of &amp;ldquo;Seriously Dishonest,&amp;rdquo; and was debarred from public procurement in Qinghai Province for three years. This case is notable in part because it shows that the NHSA is actively enforcing the updated credit evaluation system according to the revisions published in May 2025.[[N: For further analysis of the credit evaluation process and the May 2025 revisions to the process, see &lt;a href="/en/perspectives/advisories/2025/06/china-compliance-update-life-sciences-summer-2025"&gt;China Compliance Update: Life Sciences &amp;mdash; Summer 2025 | Advisories | Arnold &amp;amp; Porter.&lt;/a&gt;]] This case also demonstrates one of the key elements of the May 2025 update, that companies can avoid negative credit evaluations and the resulting penalties by proactively remediating misconduct.&lt;/p&gt;
&lt;p&gt;Chinese regulators are also taking increasingly aggressive measures to enforce the credit evaluation system throughout the supply chain. Manufacturers may be subject to credit evaluations not only for their third parties&amp;rsquo; misconduct, but the misconduct of their third parties&amp;rsquo; contractors and vendors, as shown by a model case published by the NHSA in January 2026.[[N: For further details of the model cases published by the NHSA in January 2026, see &lt;a href="/en/perspectives/advisories/2026/03/china-life-sciences-2025-year-in-review"&gt;China Life Sciences: 2025 Year in Review | Advisories | Arnold &amp;amp; Porter&lt;/a&gt;.&amp;nbsp;]]&lt;/p&gt;
&lt;p&gt;These regulatory trends demonstrate the importance of companies carefully monitoring their distributors and other third parties, and taking timely remedial action if any misconduct is found.&lt;/p&gt;
&lt;h2&gt;Unannounced NHSA Inspections: Investigator Initiated Studies and Public Procurement&lt;/h2&gt;
&lt;p&gt;As noted above, in February and March 2026 the NHSA published three case studies of unannounced inspections. Although the NHSA did not disclose what, if any, action was taken as a result of these inspections, these case studies provide valuable insights into the regulators&amp;rsquo; focus in conducting these enforcement actions.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;&lt;strong&gt;Clinical Trials&lt;/strong&gt;. One &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/3/20/art_14_19964.html" target="_blank"&gt;case study&lt;/a&gt; discussed an Investigator Initiated Study (IIS) using a drug covered by China&amp;rsquo;s state-run medical insurance program. A significant increase in the drug&amp;rsquo;s sales at the hospital where the IIS was carried out drew NHSA inspectors&amp;rsquo; attention. The inspection subsequently identified irregularities with the IIS:&amp;nbsp;
    &lt;ul&gt;
        &lt;li&gt;The pharmaceutical company paid HCPs for services that appeared to lack clinical value.
        &lt;ul&gt;
            &lt;li&gt;The IIS was designed for each patient to have follow-up visits once every two months for two years, for a total of 12 follow-up visits. However, the IIS was also designed to study late-stage cancer patients who were expected to survive 3-4 months. No patient completed any follow-up visits.&amp;nbsp;&lt;/li&gt;
            &lt;li&gt;It appears that no useful clinical data was generated from the IIS. The NHSA inspector did not identify any published work product relating to this IIS, and the clinical data generated from the IIT did not appear to have been utilized to obtain approval for additional indications.&lt;/li&gt;
            &lt;li&gt;Despite these issues, the manufacturer still paid the HCPs&amp;rsquo; service fees relating to the IIS.&amp;nbsp;&lt;/li&gt;
        &lt;/ul&gt;
        &lt;/li&gt;
        &lt;li&gt;IIS relating to the drug accounted for 25% of the total contemporaneous IIS undertaken by the hospital. Many of the other IIS relating to this drug had vague or broad clinical designs.&lt;/li&gt;
        &lt;li&gt;The pharmaceutical company had previously invested heavily in clinical trials relating to the drug but did not appear to have produced a proportionate number of academic publications, nor were these prior trials used to support applications for new indications.&lt;/li&gt;
    &lt;/ul&gt;
    &lt;/li&gt;
    &lt;li&gt;&lt;strong&gt;Public Procurement&lt;/strong&gt;. Two of the other case studies related to procurement issues.&amp;nbsp;
    &lt;ul&gt;
        &lt;li&gt;In &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/2/26/art_14_19733.html" target="_blank"&gt;one case&lt;/a&gt;, the inspector discovered that an individual engaged in bid rigging by setting up multiple pharmaceutical distributors and using these entities to participate in a hospital tender. Some of these distributors were found to be shell companies, and their legal representatives were found to have almost no substantive responsibilities.&lt;/li&gt;
        &lt;li&gt;In &lt;a rel="noopener noreferrer" href="https://www.nhsa.gov.cn/art/2026/3/17/art_14_19924.html" target="_blank"&gt;the second&lt;/a&gt; case, the inspection discovered that during the tendering process, HCPs&amp;rsquo; evaluations of the medical consumables under consideration for procurement were manipulated to favor manufacturers who had a &amp;ldquo;long-standing cooperative relationship&amp;rdquo; with the hospital.
        &lt;ul&gt;
            &lt;li&gt;The original ratings of the consumables appeared to have been modified multiple times.&amp;nbsp;&lt;/li&gt;
            &lt;li&gt;The HCPs who participated in the tender evaluation recalled that the HCP who led the process indicated that they should &amp;ldquo;prioritize&amp;rdquo; one manufacturer.&lt;/li&gt;
        &lt;/ul&gt;
        &lt;/li&gt;
    &lt;/ul&gt;
    &lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Enforcement: Patient Programs, Disease Awareness, and Industry Associations&lt;/h2&gt;
&lt;p&gt;A January administrative decision published by the Shanghai Administration for Market Regulation is notable for targeting HCPs&amp;rsquo; participation in a disease awareness program.&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;A consulting company was engaged by a pharmaceutical company to provide a patient health management platform and carry out disease awareness activities. As part of this work, the consulting company invited HCPs who had prescribed the pharmaceutical company&amp;rsquo;s product to lecture at disease awareness activities and paid service fees to the HCPs.&lt;/li&gt;
    &lt;li&gt;The AMR found that when carrying out the patient program, 18 disease awareness activities did not take place. The consulting company nevertheless paid service fees totaling RMB 25,000 (US$3,472) to HCPs for these activities.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;The consulting company was found to have provided improper benefits to HCPs and was fined RMB 100,000 (US$13,889).&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;This case stands out from the majority of published AMR enforcement matters, which typically relate to sales personnel or third parties providing benefits to HCPs in return for sales, HCPs&amp;rsquo; participation in promotional activities, and sponsorships. Following on the August 2025 enforcement actions against employees of a pharmaceutical company for improper operation of the company&amp;rsquo;s patient assistance programs,[[N: For further analysis of the news report in August 2025, see &lt;a href="/en/perspectives/advisories/2025/09/chinese-regulators-enforcement-against-medical-insurance-fraud"&gt;Chinese Regulators Continue Enforcement Actions Against Medical Insurance Fraud&lt;/a&gt;.]] this case may indicate that Chinese regulators are paying increased attention to the operation of patient programs, including disease awareness programs.&lt;/p&gt;
&lt;p&gt;The first quarter of 2026 has also seen multiple enforcement actions targeting academic and industry associations, including multiple high-ranking officials from national and provincial associations in the healthcare industry having been placed under investigation. For example, the CCDI &lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/yaowenn/202602/t20260206_474240.html" target="_blank"&gt;announced&lt;/a&gt; on February 6, 2026 that the Vice General Secretary of the China Association For Pharmaceutical Equipment, Qianhe Di (遆倩鹤), is being investigated for serious violations of laws and regulations. These enforcement actions appear to reflect efforts to actively implement the January 14, 2026 &lt;a rel="noopener noreferrer" href="https://www.ccdi.gov.cn/toutiaon/202601/t20260114_469908.html" target="_blank"&gt;Announcement of the Fifth Plenary Session of the 20th Central Commission for Discipline Inspection of the Communist Party of China&lt;/a&gt; ( 中国共产党第二十届中央纪律检查委员会第五次全体会议公报), which stated in part that in 2026, the CCDI will &amp;ldquo;further rectify corruption in key areas including finance, state-owned enterprises, energy, education, academic and industry associations, development zones, and bidding (深化整治金融、国企、能源、教育、学会协会、开发区和招标投标等重点领域腐败).&amp;rdquo;&lt;/p&gt;
&lt;p&gt;These enforcement actions show the need for companies operating in China to ensure that all public-facing activities, including patient programs, maintain a high level of compliance, and underscore the need for companies to conduct adequate due diligence and monitoring on their partnerships with academic associations.&lt;/p&gt;
&lt;p&gt;For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold &amp;amp; Porter&amp;rsquo;s &lt;a href="/en/services/capabilities/practices/life-sciences-and-healthcare-regulatory"&gt;Life Sciences&lt;/a&gt;&amp;nbsp;or &lt;a href="/en/services/capabilities/practices/white-collar-defense-and-investigations"&gt;White Collar Defense &amp;amp; Investigations&lt;/a&gt;&amp;nbsp;practice group.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;*Zhewen Zhang contributed to this Blog.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{F32419EB-27D9-408E-8153-CF4AA8CCAACE}</guid><link>https://www.arnoldporter.com/en/perspectives/news/2026/04/women-and-diversity-in-law-awards-recognize-kathleen-harris-as-law-firm-leader-of-the-year</link><title>Women and Diversity in Law Awards Recognize Kathleen Harris as Law Firm Leader of the Year</title><description>Head of Arnold &amp;amp; Porter's London office Kathleen Harris has been named Law Firm Leader of the Year &amp;ndash; International Law Firm at the Women and Diversity in Law Awards 2026, which honor outstanding women leaders and practitioners across the UK legal profession, as well as legal teams and businesses driving meaningful change.</description><pubDate>Wed, 29 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;Head of Arnold &amp;amp; Porter's London office Kathleen Harris has been named Law Firm Leader of the Year &amp;ndash; International Law Firm at the Women and Diversity in Law Awards 2026, which honor outstanding women leaders and practitioners across the UK legal profession, as well as legal teams and businesses driving meaningful change.&lt;/p&gt;
&lt;p&gt;The Law Firm Leader of the Year &amp;ndash; International Law Firm award recognizes UK-based women in leadership positions within international law firms who are &amp;ldquo;exceptional leaders, setting and delivering on strategic goals while also ensuring the business operates ethically and with integrity, guided by purpose and values, including a demonstrable commitment to furthering diversity and inclusion.&amp;rdquo; &lt;/p&gt;
&lt;p&gt;Kathleen is recognized internationally as a leader in her field and is regularly instructed by companies and individuals on a range of high-profile regulatory and criminal matters. She heads the firm&amp;rsquo;s London office, which serves a diverse range of clients across 17 practice areas, acting as a bridge between the firm's international network spanning Europe, the U.S., and Asia. Kathleen also serves as Co-Chair of Arnold &amp;amp; Porter's Diversity &amp;amp; Inclusion Committee, reflecting the firm's broader commitment to building a more inclusive profession.&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{17EB6A63-F3E8-4D1E-A266-08A0292D46DB}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/earn-outs-and-other-forms-of-contingent-consideration</link><a10:author><a10:name>Thomas Yadlon</a10:name><a10:uri>https://www.arnoldporter.com/en/people/y/yadlon-thomas</a10:uri><a10:email>thomas.yadlon@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Tracy A. Belton</a10:name><a10:uri>https://www.arnoldporter.com/en/people/b/belton-tracy-a</a10:uri><a10:email>tracy.belton@arnoldporter.com</a10:email></a10:author><title>Earn-Outs and Other Forms of Contingent Consideration: Recent Delaware Decisions and Drafting Takeaways</title><description>&lt;p&gt;In our July 2024 Advisory regarding Trifecta Multimedia Holdings Inc. v. WCG Clinical Services LLC, we noted the importance, in the earn-out context, of distinguishing between extra-contractual statements that may be treated as actionable representations and those that may be dismissed as mere &amp;ldquo;puffery,&amp;rdquo; and we highlighted the significance of clear anti-reliance language in acquisition agreements. Two more recent Delaware decisions &amp;mdash; the Court of Chancery&amp;rsquo;s post-trial opinion in Camaisa v. Pharmaceutical Research Associates, Inc. and the Delaware Supreme Court&amp;rsquo;s decision in Fortis Advisors LLC v. Johnson &amp;amp; Johnson &amp;mdash; bear on those same subjects and, in the case of Fortis, make Delaware&amp;rsquo;s position on anti-reliance language particularly clear. The decisions also implicate several other recurring questions in contingent consideration disputes, including efforts-based covenants and the limits of the implied covenant of good faith and fair dealing. We summarize the background of these cases and our principal takeaways below.&lt;/p&gt;</description><pubDate>Wed, 29 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;p&gt;In our July 2024 Advisory regarding &lt;em&gt;&lt;a href="https://www.arnoldporter.com/en/perspectives/advisories/2024/07/delaware-chancery-court-provides-guidance-in-trifecta" target="_self"&gt;Trifecta Multimedia Holdings Inc. v. WCG Clinical Services LLC&lt;/a&gt;&lt;/em&gt;, we noted the importance, in the earn-out context, of distinguishing between extra-contractual statements that may be treated as actionable representations and those that may be dismissed as mere &amp;ldquo;puffery,&amp;rdquo; and we highlighted the significance of clear anti-reliance language in acquisition agreements. Two more recent Delaware decisions &amp;mdash; the Court of Chancery&amp;rsquo;s post-trial opinion in &lt;em&gt;Camaisa v. Pharmaceutical Research Associates, Inc.&lt;/em&gt;[[N:&lt;em&gt;Camaisa v. Pharmaceutical Research Associates, Inc.&lt;/em&gt;, C.A. No. 2019-0561-NAC, 2025 WL 3049891 (Del. Ch. Oct. 28, 2025).]] and the Delaware Supreme Court&amp;rsquo;s decision in &lt;em&gt;Fortis Advisors LLC v. Johnson &amp;amp; Johnson&lt;/em&gt;[[N:&lt;em&gt;Johnson &amp;amp; Johnson v. Fortis Advisors LLC&lt;/em&gt;, No. 490, 2024, 2026 WL 89452 (Del. Jan. 12, 2026).]] &amp;mdash; bear on those same subjects and, in the case of Fortis, make Delaware&amp;rsquo;s position on anti-reliance language particularly clear. The decisions also implicate several other recurring questions in contingent consideration[[N:Contingent consideration in a transaction can take various forms, including earn-outs, milestones payments, contingent value rights and other variations. While the cases covered in this alert specifically involved contingent consideration framed as earn-outs and milestones, the analysis and takeaways included herein would apply generally to most if not all forms of contingent consideration.]] disputes, including efforts-based covenants and the limits of the implied covenant of good faith and fair dealing. We summarize the background of these cases and our principal takeaways below.&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;Camaisa&lt;/em&gt; &lt;/h2&gt;
&lt;p&gt;&lt;em&gt;Camaisa&lt;/em&gt; arose out of the acquisition by Pharmaceutical Research Associates, Inc. (PRA), a clinical research organization (CRO) of Parallel 6, Inc. (P6), a cloud-based technology company, via merger, where the maximum transaction consideration consisted 80% of cash up-front and 20% of a revenue-based earn-out that ultimately was not achieved. Following the earn-out failure, the representative of the former stockholders of P6 and former CEO of P6, Allan Camaisa (Camaisa), filed suit on behalf of the former stockholders against PRA alleging fraud and breach claims. &lt;/p&gt;
&lt;h3&gt;Fraud &lt;/h3&gt;
&lt;p&gt;P6&amp;rsquo;s fraud claim was based on an alleged representation made by a PRA senior executive during a pre-signing conference call (the Call) that P6 would be permitted to continue to operate its business autonomously during the earn-out period and continue selling to PRA&amp;rsquo;s other CRO competitors. P6 attributed the failure to achieve the earn-out on the opposite actually occurring &amp;ndash; following the transaction closing, P6 was required to operate with PRA on an integrated basis and could not sell to other CRO competitors. &lt;/p&gt;
&lt;p&gt;Notably, the transaction agreement contained a standard integration clause providing that the agreement superseded all other understandings among the parties with respect to the subject matter, but did not contain an anti-reliance clause from P6 disclaiming reliance on extra-contractual statements made by the buyer, PRA. It also included a fraud override clause which preserved the ability of either party to make fraud claims notwithstanding any other provisions in the agreement. The court noted that the inclusion of an anti-reliance clause could have resolved the fraud claim at the pleading stage in favor of PRA. &lt;/p&gt;
&lt;p&gt;The elements of a fraud claim in Delaware are as follows: (1) a false representation, (2) the maker of such representation&amp;rsquo;s knowledge of or belief in its falsity or reckless indifference to its truth, (3) an intention to induce action based on the representation, (4) reasonable reliance by the recipient on the representation, and (5) damages. The court found that P6&amp;rsquo;s fraud claim failed under both the first and fourth prongs. &lt;/p&gt;
&lt;p&gt;With respect to the first prong, the court found that the plaintiff had failed to prove the existence of an actionable false statement made on the Call by a preponderance of the evidence. The court emphasized that there was no contemporaneous record that would conclusively establish exactly what was said, and how. In the absence of such record, the court looked extensively at the surrounding circumstantial evidence including, among other things, the statements made internally within PRA in relation to P6&amp;rsquo;s prospective operations, as well as the actual behavior of the respective parties on relevant operational matters. Of particular note, the court factored in the unequivocally negative statements Camaisa made during negotiations regarding the desirability and value of an earn-out as a seller,[[N:For example, Camaisa characterized earn-outs as &amp;ldquo;plain stupid&amp;rdquo; in writing to a colleague, and testifying that at his first two sold companies, &amp;ldquo;I had no earnout. I knew better. No earnout.&amp;rdquo; &lt;em&gt;Camaisa&lt;/em&gt;, 2025 WL 3049891, at *3, *10.]] effectively indicating that in light of Camaisa&amp;rsquo;s hostility to earn-outs, the court would have expected him to (at minimum) document any promise made that would make accepting an earn-out less &amp;ldquo;stupid.&amp;rdquo; The court also observed that the alleged representation was inconsistent with the covenant in the transaction agreement that allowed PRA broad discretion over the post-closing operation of the P6 business,[[N:The court referenced Section 2.7(h) of the transaction agreement, which provides that &amp;ldquo;(i) Parent and its Affiliates will be entitled to effect the integration of the Surviving Corporation and its business, assets and personnel with Parent and its Affiliates, (ii) Parent and its Affiliates shall have the right to direct the overall operations and strategy of the business of the Surviving Corporation and may make all management decisions with respect to the Surviving Corporation and its business (including all decisions with respect to the research, development, marketing and sale of its products and services&amp;hellip;)&amp;rdquo; Id. at *5-6.]] and noted that the legal doctrine under Delaware caselaw[[N:Id. at *14 (citing &lt;em&gt;Paperless Solutions Group, Inc. v. MIB Group, Inc.&lt;/em&gt;, 2025 WL 1466603, at *4 (Del. Super. May 21, 2025) at *3 (citing &lt;em&gt;Chapter 7 Trustee Constantino Flores v. Strauss Water Ltd.&lt;/em&gt;, 2016 WL 5243950, at *6 (Del. Ch. Sept. 22, 2016)).]] that a party cannot prove justifiable reliance where the contract contradicts an allegedly inducing misrepresentation provided evidence that P6 did not justifiably rely on the alleged representation in this instance. &lt;/p&gt;
&lt;p&gt;The court went on to determine that even if plaintiff had successfully proven the existence of an actionable false statement, the fraud claim would necessarily fail because P6 could not have justifiably relied on it. &lt;/p&gt;
&lt;p&gt;Noting that the analysis of whether there is an actionable representation and reliance is &amp;ldquo;bound up together,&amp;rdquo; the court indicated that the inconsistency of the alleged representation with the provision providing broad discretion to PRA for post-closing operations strongly factored against finding reliance, as did Camaisa&amp;rsquo;s starkly unfavorable views regarding the value of earn-outs and his sophistication and prior experience. Similarly, certain actions of the parties that were noted to have factored against finding a false representation were also noted to affect reliance. One factor bearing only on reliance was the court&amp;rsquo;s evaluation of the evidence on &lt;em&gt;how&lt;/em&gt; the statements were made, and that because Camaisa viewed the statements as having been made in the manner of a salesperson taken together with P6&amp;rsquo;s description of the general tenor of the call, such statements could be viewed to be &amp;ldquo;non-actionable puffery&amp;rdquo; that could not support a fraud claim, citing to &lt;em&gt;Trifecta&lt;/em&gt;. &lt;/p&gt;
&lt;h3&gt;Breach &lt;/h3&gt;
&lt;p&gt;P6 also alleged that PRA breached the earn-out anti-frustration covenant in the merger agreement, which provided that PRA would &amp;ldquo;not knowingly take (or knowingly cause any of its controlled Affiliates to take) any action for the &lt;em&gt;primary purpose&lt;/em&gt; of preventing the achievement of the Contingent Consideration&amp;rdquo; [emphasis added]. The court noted that proving a breach of the primary purpose standard is a heavy burden, referencing that in a prior case with substantially identical language, the court had determined that a buyer could &amp;ldquo;take actions &amp;hellip; knew would frustrate [an earnout], so long as the action has some other primary purpose.&amp;rdquo;[[N:Id. at *16, citing &lt;em&gt;Fortis Advisors LLC v. Medtronic Minimed, Inc.&lt;/em&gt;, 2024 WL 3580827, at *5 (Del. Ch. July 29, 2024).]] In practice, this standard affords buyers significant operational flexibility, even where their actions foreseeably impair earn-out performance.&lt;/p&gt;
&lt;p&gt;Evaluating several alleged violations by PRA under this high standard where PRA took actions during the earn-out period that would ordinarily be expected to adversely affect P6 sales, the court determined that PRA did not violate the covenant and had legitimate business purposes for all of them. For example, during the relevant earn-out period, PRA did scale back P6&amp;rsquo;s inclusion in new proposals. However, the court found that such practices were driven by poor performance of P6&amp;rsquo;s products and related customer complaints, and were not primarily motivated to avoid the earn-out. The other alleged covenant breach violations failed under similar analyses.&lt;/p&gt;
&lt;h2&gt;&lt;em&gt;Auris&lt;/em&gt;&lt;/h2&gt;
&lt;p&gt;Auris arose out of Johnson &amp;amp; Johnson&amp;rsquo;s (J&amp;amp;J) 2019 acquisition of Auris Health, Inc. (Auris), a medical robotics company having two product platforms at various stages of development at the time of the transaction. The transaction consideration consisted of approximately 60% of cash up-front and 40% in contingent earn-outs tied to ten milestone events &amp;mdash; eight based on regulatory milestones and two based on net sales. The regulatory milestones were each expressly conditioned on obtaining &amp;ldquo;510(k) premarket notification&amp;rdquo; from the Food and Drug Administration (FDA), a specific and relatively streamlined regulatory pathway. Following the failure of all 10 earn-out milestones, Fortis Advisors LLC (Fortis), acting as the representative of Auris&amp;rsquo; former stockholders, filed suit against J&amp;amp;J alleging fraud, breach of contract, and breach of the implied covenant of good faith and fair dealing.&lt;/p&gt;
&lt;p&gt;Fortis prevailed in certain of its breach and fraud claims in the Chancery Court decision, which decision was appealed by J&amp;amp;J and largely affirmed by the Delaware Supreme Court.&lt;/p&gt;
&lt;h3&gt;Fraud&lt;/h3&gt;
&lt;p&gt;At the Chancery Court, Fortis asserted fraud claims based on a number of statements which the Chancery Court characterized as either true or non-actionable &amp;ldquo;puffery&amp;rdquo; statements of the type that commercial parties routinely make as part of deal-making courtship, including that: (1) Auris&amp;rsquo; and J&amp;amp;J&amp;rsquo;s competing products were &amp;ldquo;complementary&amp;rdquo;; (2) &amp;ldquo;Auris had J&amp;amp;J&amp;rsquo;s &amp;lsquo;resources at [its] sails&amp;rsquo; to develop [Auris&amp;rsquo; products]&amp;rdquo;; (3) &amp;ldquo;J&amp;amp;J would spend &amp;ldquo;multiples&amp;rdquo; of what Auris alone could devote to its technology&amp;rdquo;; (4) &amp;ldquo;[Auris&amp;rsquo; product] was a &amp;lsquo;priority&amp;rsquo;&amp;rdquo;; (5) &amp;ldquo;J&amp;amp;J would &amp;ldquo;retain [Auris&amp;rsquo;] leadership / team by creating a semi-autonomous model&amp;rdquo;; (6) &amp;ldquo;J&amp;amp;J would be &amp;lsquo;deferential&amp;rsquo; to [the Auris CEO];&amp;rdquo; and (7) &amp;ldquo;unlike in prior mergers, it was going to &amp;lsquo;do Silicon Valley well &amp;hellip; this time.&amp;rsquo;&amp;rdquo;[[N:&lt;em&gt;Fortis Advisors LLC v. Johnson &amp;amp; Johnson&lt;/em&gt;, C.A. No. 2020-0881-LWW, 2024 WL 4048060 (Del. Ch. Sept. 4, 2024).]] These findings were not appealed by Fortis, and were referenced without further discussion in the Supreme Court decision.&lt;/p&gt;
&lt;p&gt;The Chancery Court did, however, find J&amp;amp;J liable for common law fraud with respect to one of Fortis&amp;rsquo; fraud claims. During negotiations, a senior executive of J&amp;amp;J told Auris that there was such a &amp;ldquo;high certainty&amp;rdquo; of achieving a proposed $100 million regulatory milestone that J&amp;amp;J viewed it as an &amp;ldquo;effective up front&amp;rdquo; payment. However, the court found that J&amp;amp;J (and specifically, J&amp;amp;J&amp;rsquo;s deal team) was aware at the time that a patient in its clinical study of a different device needed to achieve the milestone had recently died, prompting the FDA to open a for-cause investigation that could threaten substantial delay, none of which was disclosed to Auris until after closing. The Chancery Court described this fraud theory as &amp;ldquo;being markedly different than the other [fraud claims]&amp;rdquo; but did not provide a substantive explanation as to the basis for the distinction. The Supreme Court found no clear error in the Chancery Court&amp;rsquo;s finding.&lt;/p&gt;
&lt;p&gt;Similar to Camaisa, the merger agreement in Auris contained a standard integration clause but no anti-reliance clause in favor of the buyer, J&amp;amp;J. In its holding, the Supreme Court reinforced that an integration clause cannot serve to waive fraud liability and that only an unmistakable anti-reliance clause would suffice. As part of its holding, the court rejected J&amp;amp;J&amp;rsquo;s argument that a (fairly typical) exclusive remedy provision in the indemnity could suffice where an integration clause could not, reasoning that allowing for such a clause to eliminate extra-contractual fraud liability would render the one-way non-reliance provision in favor of Auris superfluous. &lt;/p&gt;
&lt;h3&gt;Breach &lt;/h3&gt;
&lt;p&gt;The merger agreement required J&amp;amp;J to use &amp;ldquo;commercially reasonable efforts&amp;rdquo; to achieve the various regulatory milestones. As is typical in acquisition agreements containing the type of product development earn-out milestones included in &lt;em&gt;Fortis&lt;/em&gt;/&lt;em&gt;Auris&lt;/em&gt;, &amp;ldquo;commercially reasonable efforts&amp;rdquo; was specifically defined and required J&amp;amp;J to expend efforts and resources &amp;ldquo;consistent with [its] usual practice &amp;hellip; with respect to priority medical device products of similar commercial potential at a similar stage in product lifecycle.&amp;rdquo; The agreement also specified 10 factors that J&amp;amp;J could take into account in setting its level of efforts, which included safety and efficacy issues, development and commercialization risks, competitiveness, intellectual property positioning, the likelihood or difficulty of obtaining regulatory approvals, other regulatory issues, and expected profitability. Finally, the agreement prohibited J&amp;amp;J from taking any action with the intention of avoiding any earn-out payment or &amp;ldquo;based on taking into account the cost of making any&amp;rdquo; earn-out payment (the No Intentional Avoidance Provision). &lt;/p&gt;
&lt;p&gt;The Chancery Court found, and the Supreme Court affirmed, that J&amp;amp;J breached this efforts obligation. On appeal, it was uncontested that both J&amp;amp;J and Auris understood that J&amp;amp;J&amp;rsquo;s orthopedic surgical robot, Velys, was the only comparable &amp;ldquo;priority&amp;rdquo; device. Most importantly for the court&amp;rsquo;s analysis, it determined that J&amp;amp;J&amp;rsquo;s commercially reasonable efforts obligations &lt;em&gt;first&lt;/em&gt; were required to be consistent with J&amp;amp;J&amp;rsquo;s usual practice for &amp;ldquo;priority&amp;rdquo; devices, and &lt;em&gt;then only within that lens&lt;/em&gt; could the 10 factors be considered. Any alternate reading, the court reasoned, would render the &amp;ldquo;priority&amp;rdquo; contractual language superfluous or internally inconsistent. In effect, the court treated the &amp;ldquo;priority&amp;rdquo; designation as a binding benchmark rather than a general reference point, significantly limiting the buyer&amp;rsquo;s ability to justify deviations based on broader business considerations. Accordingly, a sufficiently adverse result on any of the 10 factors would not permit J&amp;amp;J to override the contractually agreed priority baseline specification. Several of J&amp;amp;J&amp;rsquo;s post-closing actions with respect to one of Auris&amp;rsquo; products were determined to have breached the merger agreement efforts obligation under this standard, including (1) J&amp;amp;J holding an internal technological competition between Auris&amp;rsquo; device and another surgical robot J&amp;amp;J was developing in a joint venture shortly after closing to determine which product would remain operative going forward, which was inherently problematic given the possibility of an Auris&amp;rsquo; device loss and also resulted in significant resource drain and time delay, (2) the combination of the Auris product with another J&amp;amp;J product to prop up the J&amp;amp;J product&amp;rsquo;s issues, (3) changes in the regulatory approval strategy taken by J&amp;amp;J which negatively affected timing, and (4) changes to employee incentives that were disaligned with the achievement of the earn-out milestones.[[N:The Chancery Court found that J&amp;amp;J satisfied the standard with respect to Auris&amp;rsquo; other product line.]] &lt;/p&gt;
&lt;p&gt;The Supreme Court also referenced the Chancery Court&amp;rsquo;s finding that J&amp;amp;J knew that certain of its post-closing actions would likely cause an earn-out failure, and on at least one occasion selected a course of action noting a &amp;ldquo;good overall value case&amp;rdquo; factoring in that contingent payments would not need to be made. The court used a similar analysis to rebut the proposition that actions taken within the discretion provided to J&amp;amp;J through the &amp;ldquo;ten factors&amp;rdquo; would negate breaches of No Intentional Avoidance Provision, indicating that if actions taken on the basis of any of the &amp;ldquo;ten factors&amp;rdquo; could override such provision, then the provision was superfluous.&lt;/p&gt;
&lt;h3&gt;Implied Covenant of Good Faith and Fair Dealing&lt;/h3&gt;
&lt;p&gt;After the merger closed, the FDA informed J&amp;amp;J that one of the relevant Auris&amp;rsquo; products would no longer be eligible for regulatory approval through the 510(k) clearance and would instead need to proceed through a different and somewhat more onerous regulatory route. This distinction was critical because the earn-out milestones were expressly conditioned on obtaining 510(k) clearance. The Chancery Court, invoking the implied covenant of good faith and fair dealing, held that J&amp;amp;J was required to use commercially reasonable efforts to pursue the alternate regulatory approval and to treat such pathway as the functional equivalent of the 510(k) clearance specified in the contract.&lt;/p&gt;
&lt;p&gt;The Supreme Court reversed on this point. The court noted that the implied covenant of good faith and fair dealing is a limited gap-filler that is designed to enforce the parties&amp;rsquo; reasonable expectations in unforeseeable circumstances that they failed to address in their contract, and that it cannot be used to rewrite or renegotiate terms that have become undesirable for either party. The Supreme Court held that there was no gap to fill in this case &amp;mdash; the merger agreement repeatedly and expressly conditioned each regulatory milestone specifically (and only) on 510(k) premarket notification. Especially in light of the sophistication of the parties and the regulated industry, the risk that the FDA might require a different pathway was foreseeable. Other provisions of the merger agreement acknowledged the possibility of FDA developments affecting the route, timing, and cost of approval, further confirming that this category of risk was considered by the parties. While declining to apply the implied covenant, the Supreme Court&amp;rsquo;s reversal did not disturb J&amp;amp;J&amp;rsquo;s obligations with respect to the remaining milestones: because an alternative regulatory path could serve as the predicate for future 510(k) submissions, J&amp;amp;J remained bound by its express efforts obligations to pursue 510(k) clearance for the other, later, milestones. Put another way, the Supreme Court determined that implicit in the later milestones was an obligation to obtain &lt;em&gt;any&lt;/em&gt; regulatory approval that would allow them to be achieved, irrespective of what the initial milestone did or did not contemplate. &lt;/p&gt;
&lt;h2&gt;Key Takeaways&lt;/h2&gt;
&lt;ul&gt;
    &lt;li&gt;These cases reinforce a critical takeaway from our &lt;em&gt;Trifecta&lt;/em&gt; alert: that buyers should include explicit anti-reliance provisions in addition to standard integration clauses. The Delaware Supreme Court has eliminated any ambiguity as to whether any other clause in the agreement will suffice for the same purpose, and only a clear statement will do.&lt;/li&gt;
    &lt;li&gt;There is little clear guidance as to what constitutes &amp;ldquo;puffery&amp;rdquo; versus an actionable representation, creating uncertainty for parties engaging in pre-signing discussions. While we have not seen a court frame the analysis in these terms, it essentially appears to be an &amp;ldquo;I know it when I see it&amp;rdquo; test. Given that it is impractical and unlikely for buyers and sellers to &lt;em&gt;entirely avoid&lt;/em&gt; extra-contractual discussions in relation to their expectations for post-closing operations, beyond a general word of caution to buyers that their reassurances could become actionable representations under the &amp;ldquo;right&amp;rdquo; circumstances, the lack of predictability on this point reinforces our first takeaway. Having a clear and unequivocal anti-reliance clause should provide vital protection against later claims arising from such statements. &lt;br /&gt;
    &lt;ul&gt;
        &lt;li&gt;This also reinforces that, for sellers, statements made during negotiations that are central to their decision to proceed are best protected by being expressly incorporated into the purchase agreement. &lt;/li&gt;
    &lt;/ul&gt;
    &lt;/li&gt;
    &lt;li&gt;Buyers should be cautious in relying on broad statements of operational discretion providing an effective commercial override of the primary obligation to use their efforts to achieve a particular result. In &lt;em&gt;Fortis&lt;/em&gt;/&lt;em&gt;Auris&lt;/em&gt;, it is unclear to what extent the &amp;ldquo;priority&amp;rdquo; product designation was the main reason why the override was disallowed, or whether it would have also been disallowed under a general efforts standard for a regular (non-priority) product. The same reasoning used by the Supreme Court in seeking to avoid superfluous provisions could have also been applied to a non-priority efforts level. &lt;/li&gt;
    &lt;li&gt;Negotiators for buyers should be cautious about agreeing to a particular reference band of efforts (e.g., such as &amp;ldquo;priority&amp;rdquo;), and understand that the contractual term could be interpreted under a standard of strict literalism. In evaluating particular efforts levels, the court in &lt;em&gt;Fortis&lt;/em&gt;/&lt;em&gt;Auris&lt;/em&gt; gave significant weight to the &amp;ldquo;priority&amp;rdquo; product designation and there was only one other example reference point to compare that standard against. An equally concerning scenario would be where the buyer agreed to treat the product as a &amp;ldquo;priority&amp;rdquo; or &amp;ldquo;highest priority&amp;rdquo; &lt;em&gt;without&lt;/em&gt; any further definition, and a court could frame the analysis in any way that &lt;em&gt;it&lt;/em&gt; would hypothetically view such a designation.[[N:A court may be presented with industry-based information for the term, but in the absence of clear facts indicating that there was an industry standard for the term, the court would have enormous interpretive discretion on the point.]] It would be risky to assume that a term included as a reference point in the agreement would be considered a form of industry &amp;ldquo;puffery&amp;rdquo; by a court.&lt;/li&gt;
    &lt;li&gt;The &amp;ldquo;primary purpose&amp;rdquo; standard in anti-frustration covenants sets a high bar for sellers and affords buyers substantial flexibility, even where their actions foreseeably impair the earn-out. Given the impact of the provision, counsel to selling parties would be well-served to specifically highlight this clause to their client, and ideally provide an example fact pattern or two, so they have a clear understanding of the clause&amp;rsquo;s implications before agreeing to it. &lt;/li&gt;
    &lt;li&gt;The implied covenant of good faith and fair dealing will not be used to reallocate risks that were foreseeable at the time of contracting, and will not be used to &amp;ldquo;paint over contractual provisions that one side later regrets.&amp;rdquo;&lt;/li&gt;
&lt;/ul&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item><item><guid isPermaLink="false">{95CC94B0-B707-4368-9090-9E39ACCFF029}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/implementing-the-genius-act-fincen-and-ofac-propose</link><a10:author><a10:name>Amber A. Hay</a10:name><a10:uri>https://www.arnoldporter.com/en/people/h/hay-amber-a</a10:uri><a10:email>amber.hay@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Anthony Raglani</a10:name><a10:uri>https://www.arnoldporter.com/en/people/r/raglani-anthony</a10:uri><a10:email>anthony.raglani@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Kevin M. Toomey</a10:name><a10:uri>https://www.arnoldporter.com/en/people/t/toomey-kevin-m</a10:uri><a10:email>kevin.toomey@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Christopher L. Allen</a10:name><a10:uri>https://www.arnoldporter.com/en/people/a/allen-christopher-l</a10:uri><a10:email>Christopher.Allen@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Erik Walsh</a10:name><a10:uri>https://www.arnoldporter.com/en/people/w/walsh-erik</a10:uri><a10:email>erik.walsh@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Paul Lim</a10:name><a10:uri>https://www.arnoldporter.com/en/people/l/lim-paul</a10:uri><a10:email>paul.lim@arnoldporter.com</a10:email></a10:author><title>Implementing the GENIUS Act: FinCEN and OFAC Propose AML and Sanctions Program Requirements</title><description>&lt;p&gt;The U.S. Department of the Treasury&amp;rsquo;s (Treasury) Financial Crimes Enforcement Network (FinCEN) and the Office of Foreign Assets Control (OFAC) recently issued a joint proposed rulemaking (Proposal) that would implement the anti-money laundering and sanctions program requirements of the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act).[[N: Treasury, &lt;a rel="noopener noreferrer" href="https://home.treasury.gov/news/press-releases/sb0435" target="_blank"&gt;Treasury Proposes Rule to Implement the GENIUS Act&amp;rsquo;s Requirements to Counter Illicit Finance&lt;/a&gt; (Apr. 8, 2026).]] If adopted as proposed, the new program requirements would apply to &amp;ldquo;permitted payment stablecoin issuers&amp;rdquo; (PPSIs) as defined by the GENIUS Act and would become effective 12 months after publication of the final rule. In addition to seeking general comments on the Proposal, FinCEN and OFAC posed nearly 60 specific questions on which they solicited feedback. Comments are due by June 9, 2026.&lt;/p&gt;
&lt;p&gt;The Proposal, which follows an advance notice of proposed rulemaking in the fall of 2025,[[N: GENIUS Act Implementation, 90 Fed. Reg. 45159 (Sept. 19, 2026).]] would impose five general categories of obligations on PPSIs, as discussed below.&lt;/p&gt;
&lt;h2&gt;Written Anti-Money Laundering and Countering the Financing of Terrorism (AML/CFT) Compliance Program&lt;/h2&gt;
&lt;p&gt;The AML/CFT program would include policies and procedures (including a mandatory risk assessment process), independent testing, ongoing training, and designation of an AML/CFT Officer. The Proposal largely mirrors the proposed revisions to existing BSA/AML program requirements for most financial institutions (including banks and broker dealers) recently issued by FinCEN, including the formalization of the risk-assessment requirement, the incorporation of the previous fifth &amp;ldquo;pillar&amp;rdquo; (Customer Due Diligence) into the &amp;ldquo;policies and procedures&amp;rdquo; pillar, and the redesignation of the program&amp;rsquo;s title from &amp;ldquo;BSA/AML&amp;rdquo; to &amp;ldquo;AML/CFT.&amp;rdquo; PPSIs would also be subject to the due-diligence and enhanced due-diligence requirements applicable to certain private banking and correspondent accounts under the USA PATRIOT Act, as well as any &amp;ldquo;Special Measures&amp;rdquo; that FinCEN imposes under Section 311 of that Act. The AML/CFT program would require board-level (or similar) approval.&lt;/p&gt;
&lt;p&gt;Significantly, the Proposal would adopt FinCEN&amp;rsquo;s new approach to supervision and enforcement, whereby neither FinCEN nor the relevant prudential regulator would take a significant enforcement or major supervisory action against a PPSI for an AML/CFT program violation unless the failure constituted &amp;ldquo;a significant or systemic failure to maintain that program.&amp;rdquo;&lt;/p&gt;
&lt;h2&gt;Suspicious Activity Reporting&lt;/h2&gt;
&lt;p&gt;PPSIs would be required to file suspicious activity reports (SARs) to advise law enforcement of suspected violations of law. Notably, the requirement would apply only to transactions occurring on the PPSI&amp;rsquo;s primary market (i.e., transactions in which the PPSI is directly involved), not to transactions occurring on the secondary market for the PPSI&amp;rsquo;s stablecoin offering. A $5,000 threshold would apply.&lt;/p&gt;
&lt;h2&gt;Recordkeeping; Information Sharing&lt;/h2&gt;
&lt;p&gt;PPSIs would be subject to recordkeeping requirements similar to those of other financial institutions, including the Recordkeeping Rule and the Travel Rule (regarding certain funds transfers and the conveyance of payment details to other institutions, respectively). Certain cross-border transfers of assets, as well as certain extensions of credit, would also be covered. A five-year retention period would apply.&lt;/p&gt;
&lt;p&gt;PPSIs would also be expressly covered by sections 314(a) and (b) of the USA PATRIOT Act. Section 314(a) requires institutions to provide certain information to FinCEN upon request. Section 314(b) permits institutions, on a voluntary basis, to share information among themselves to assist with identifying and reporting possible money laundering or terrorist activity.&lt;/p&gt;
&lt;h2&gt;Effective Sanctions Compliance Program&lt;/h2&gt;
&lt;p&gt;PPSIs would be required to adopt and maintain a sanctions compliance program with five key elements:&lt;/p&gt;
&lt;ul&gt;
    &lt;li&gt;Senior management and organizational commitment (including that the program be fully integrated in the PPSI&amp;rsquo;s payment stablecoin operations and apply to all payment stablecoin activity; allow for sufficient authority, autonomy, and resources; and routinely provide updates and testing reports to senior management and other appropriate personnel).&lt;/li&gt;
    &lt;li&gt;Periodic holistic sanctions-related risk assessments, updated as circumstances warrant, to be used to inform and update the PPSI&amp;rsquo;s sanctions compliance program.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Risk-based internal controls to identify and take appropriate action in response to payment stablecoin transactions (on both primary and secondary markets) that would violate U.S. sanctions laws.&amp;nbsp;&lt;/li&gt;
    &lt;li&gt;Independent testing/auditing with appropriate accountability, resources, expertise, and authority.&lt;/li&gt;
    &lt;li&gt;Ongoing risk-based training tailored to the institution and its relevant personnel and stakeholders. Standard OFAC recordkeeping and reporting requirements would apply.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2&gt;Ability To Block, Freeze, and Reject Certain Specified or Impermissible Transactions&lt;/h2&gt;
&lt;p&gt;PPSIs would be required to have &amp;ldquo;technical capabilities, policies, and procedures to block, freeze, and reject specific or impermissible transactions that violate Federal or State laws, rules, or regulations.&amp;rdquo; Such capability would need to include the ability to comply with any &amp;ldquo;lawful order.&amp;rdquo; As with the sanctions compliance program, and unlike the proposed SARs rule, this requirement covers both a PPSI&amp;rsquo;s primary and secondary markets.&lt;/p&gt;
&lt;h2&gt;Takeaways&lt;/h2&gt;
&lt;p&gt;Although the Proposal incorporates new material such as the formalized risk-assessment process and the mandatory sanctions compliance program, in many ways it adheres to existing regulations and supervisory expectations. However, FinCEN has had to tailor existing regulations significantly to adapt the Proposal to the unique circumstances of PPSIs and payment stablecoins, and industry participants should take particular note of the technical aspects of the Proposal and offer feedback where appropriate. Also, in addition to numerous questions about the Proposal&amp;rsquo;s specific provisions, FinCEN has asked for comments on how, for PPSIs that are subsidiaries of financial institutions, the proposed requirements will or will not integrate effectively into existing organizational AML/CFT programs, and has also asked whether any of the Proposal&amp;rsquo;s provisions should be extended to foreign payment stablecoin issuers.&lt;/p&gt;
&lt;p&gt;If you have any questions regarding the Proposal or need assistance in determining whether to comment on the Proposal, please contact any of the authors of this Advisory or your usual firm contact.&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</description><pubDate>Tue, 28 Apr 2026 00:00:00 -0500</pubDate></item><item><guid isPermaLink="false">{25C09776-C0A3-4E38-A2DC-281689685FBC}</guid><link>https://www.arnoldporter.com/en/perspectives/advisories/2026/04/hhs-tries-again-to-improve-availability-of-innovative-devices-in-medicare</link><a10:author><a10:name>Thomas A. Gustafson, Ph.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/g/gustafson-thomas-a</a10:uri><a10:email>Thomas.Gustafson@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Philip R. Desjardins</a10:name><a10:uri>https://www.arnoldporter.com/en/people/d/desjardins-philip-r</a10:uri><a10:email>philip.desjardins@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Bobby McMillin</a10:name><a10:uri>https://www.arnoldporter.com/en/people/m/mcmillin-bobby</a10:uri><a10:email>bobby.mcmillin@arnoldporter.com</a10:email></a10:author><a10:author><a10:name>Monique Nolan, M.D., J.D.</a10:name><a10:uri>https://www.arnoldporter.com/en/people/n/nolan-monique</a10:uri><a10:email>monique.nolan@arnoldporter.com</a10:email></a10:author><title>U.S. Health and Human Services Tries Again To Improve Availability of Innovative Devices in Medicare</title><description>&lt;p&gt;On April 23, 2026, the Centers for Medicare &amp;amp; Medicaid Services and the U.S. Food and Drug Administration (FDA) announced a plan to create a new pathway to expedite Medicare coverage for certain medical devices designated by the FDA as breakthrough devices (the Announcement). Devices travelling the new Regulatory Alignment for Predictable and Immediate Device pathway, which would in effect be run jointly by the two agencies, are expected to experience fewer delays between FDA market authorization and Medicare national coverage determinations than at present, as long as they meet certain requirements.&amp;nbsp;&lt;/p&gt;</description><pubDate>Tue, 28 Apr 2026 00:00:00 -0500</pubDate><a10:content type="html">&lt;p&gt;
&lt;h2&gt;Introduction&lt;/h2&gt;
&lt;p&gt;On April 23, 2026, the Centers for Medicare &amp;amp; Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced a plan to create a new pathway to expedite Medicare coverage for certain medical devices designated by the FDA as breakthrough devices (the Announcement).[[N:See &lt;a rel="noopener noreferrer" href="https://www.fda.gov/news-events/press-announcements/cms-and-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices" target="_blank"&gt;FDA News Release&lt;/a&gt; and &lt;a rel="noopener noreferrer" href="https://www.cms.gov/newsroom/press-releases/cms-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices" target="_blank"&gt;CMS Press Release&lt;/a&gt; (Apr. 23, 2026).]] Devices travelling the new Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, which would in effect be run jointly by the two agencies, are expected to experience fewer delays between FDA market authorization and Medicare national coverage determinations than at present, as long as they meet certain requirements. &lt;/p&gt;
&lt;p&gt;The two agencies would work closely together with sponsors earlier in the development process to align regulatory and coverage expectations in advance and to facilitate use by CMS of evidence generated for FDA review.[[N:CMS and FDA have previously attempted to more closely align their respective reviews as a means to facilitate a quicker access to medical technology following FDA authorization, for example, under the Parallel Review Pilot Program and Program for Parallel Review of Medical Devices.]]&lt;/p&gt;
&lt;p&gt;This announcement anticipates publication in the Federal Register of a formal proposal detailing the pathway sometime &amp;ldquo;soon.&amp;rdquo; The proposal would be open for comments for 60 days and followed by a final notice. The agencies expect to launch the new pathway at the time the final notice is published, but the agencies have not provided any information about when that will be. &lt;/p&gt;
&lt;p&gt;While the details available at present are incomplete, the following sections provide a high-level summary of the expected RAPID proposal and attempts to place this initiative in the context of a number of related proposals.&lt;/p&gt;
&lt;h2&gt;Summary of the RAPID Coverage Pathway &lt;/h2&gt;
&lt;p&gt;According to the Announcement, breakthrough devices eligible for the RAPID pathway would include Class III devices and certain Class II devices that participate in the FDA Total Product Life Cycle Advisory Program (TAP). In addition, the devices would need to be the subject of an Investigational Device Exemption (IDE) study enrolling Medicare beneficiaries and investigating clinical health outcomes agreed to by FDA and CMS. &lt;/p&gt;
&lt;p&gt;The forthcoming RAPID coverage pathway proposal is likely to be most beneficial for high risk, evidence intensive breakthrough devices, particularly Class III products, which require PMA approval and target serious or life threatening conditions, many of which are common in the Medicare population. These include therapies and diagnostic tools where FDA review already depends on prospective IDE studies with meaningful clinical endpoints. For these technologies, RAPID may offer the greatest value by reducing the longstanding lags between FDA market authorization and Medicare coverage determinations, provided sponsors are willing to engage early with both agencies and generate evidence that satisfies FDA safety and effectiveness standards as well as CMS&amp;rsquo; reasonable and necessary coverage criteria.&lt;/p&gt;
&lt;p&gt;The pathway may also benefit a subset of Class II breakthrough devices,[[N:As of this writing, the agencies have not provided details on which Class II devices would be eligible.]] but only where those products participate in FDA&amp;rsquo;s (TAP) program, making TAP a critical gateway for such devices. For these devices, RAPID may provide a benefit that builds on the early, frequent FDA engagement already offered under TAP by formally including CMS in those discussions, particularly around endpoint selection, study design, and Medicare relevant outcomes. In practice, CMS&amp;rsquo; inclusion will likely make RAPID participation of most benefit for complex Class II technologies, such as novel diagnostics or device enabled therapies, while reinforcing TAP&amp;rsquo;s role as the FDA mechanism for identifying Class II devices whose risk profile and clinical impact justify intensified attention. &lt;/p&gt;
&lt;p&gt;The agencies expect that on the same day an eligible device receives FDA market authorization, CMS will issue a proposed National Coverage Determination (NCD) for the device, which will trigger a 30-day comment period. A final NCD may follow very shortly, which &lt;em&gt;could&lt;/em&gt; enable Medicare coverage and payment in as little as two months following market authorization (versus a year or more at present). &lt;/p&gt;
&lt;p&gt;The agencies note that CMS will continue to offer multiple pathways for coverage of devices, including the existing NCD process, so sponsors presumably will continue to be able to avail themselves of the existing pathways if RAPID appears unnecessary or too cumbersome for a particular device. &lt;/p&gt;
&lt;p&gt;The agencies give no suggestion that the standards used by FDA for market authorization or those employed by CMS for coverage will change. &lt;/p&gt;
&lt;h2&gt;Related Proposals&lt;/h2&gt;
&lt;p&gt;The RAPID pathway proposal marks CMS&amp;rsquo; third attempt to address concerns about coverage of breakthrough devices. In early 2021, near the end of the first Trump administration, CMS issued regulations setting up the Medicare Coverage for Innovative Technologies (MCIT) program. MCIT would have expedited coverage for all breakthrough devices, but it was never implemented. CMS replaced it with the narrower Transitional Coverage for Emerging Technologies (TCET) program, which tied coverage to the Coverage with Evidence Development pathway. TCET has been little used. The current announcement indicates that the TCET pathway will be &amp;ldquo;paused for new candidates&amp;rdquo; as CMS concentrates on implementing the RAPID program. &lt;/p&gt;
&lt;p&gt;In Congress, policies that would bring greater certainty to the coverage prospects for breakthrough devices have received broad, bipartisan support. As recently as April 21, 2026, a bipartisan group of 82 lawmakers wrote to Secretary Kennedy and CMS Administrator Oz &lt;a rel="noopener noreferrer" href="https://d12t4t5x3vyizu.cloudfront.net/yakym.house.gov/uploads/2026/04/Quill-Letter-L32954-CMS-coverage-of-breakthrough-medical-devices-Version-2-04-21-2026-@-09-15-AM.pdf" target="_blank"&gt;expressing support&lt;/a&gt; for &amp;ldquo;comprehensive Medicare coverage of breakthrough medical device technologies.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;In September 2025, the House Ways and Means Committee advanced H.R. 5343, the &amp;ldquo;Ensuring Patient Access to Critical Breakthrough Products Act&amp;rdquo; by a vote of 37-3. The legislation would create a four-year transitional coverage period during which breakthrough devices would be covered and impose a requirement to issue final coverage decisions during that time, provided certain procedural requirements are met. The &lt;a rel="noopener noreferrer" href="https://www.cbo.gov/publication/61903" target="_blank"&gt;Congressional Budget Office has estimated&lt;/a&gt; the total cost of the legislation to be just under $1 billion over 10 years, though the administration&amp;rsquo;s advancement of RAPID could lower the costs depending upon its final form.&lt;/p&gt;
&lt;p&gt;In the proposed rule updating Medicare&amp;rsquo;s Inpatient Prospective Payment System (IPPS) for FY27, CMS has proposed changing the payment provisions applicable to certain new technologies to remove favorable treatment for breakthrough devices.[[N:91 Fed Reg 19457-19459, April 14, 2026.]] At present, breakthrough devices are deemed to automatically meet an otherwise applicable requirement to demonstrate substantial clinical improvement in order to qualify for New Technology Add-on Payments under the IPPS and Transitional Pass-Through Payments under Medicare&amp;rsquo;s Outpatient Prospective Payment System (OPPS). These proposals, if adopted, would mean sponsors of breakthrough devices, in order to secure either of these special payment provisions, would have to provide evidence that their products met the improvement criterion on the same basis as devices without breakthrough designation. Note that these proposals affect payment, as distinct from the RAPID pathway, which would address coverage. &lt;/p&gt;
&lt;h2&gt;Proposals and Comment Opportunities&lt;/h2&gt;
&lt;p&gt;RAPID will likely be well received by industry and seen as a constructive step toward reducing longstanding delays between FDA market authorization and Medicare coverage for breakthrough devices, but the devil will be in the details. Specifications of many important aspects of the RAPID pathway have not yet been made available, and we expect great interest to attach to the details of how the IDE studies will be set up and followed (for instance, whether coverage may be removed at a later time if studies do not support long-term coverage and how devices newly covered under the RAPID pathway will fit in the existing Medicare payment systems, just to name a few considerations). We anticipate that stakeholders will closely scrutinize CMS&amp;rsquo; plans for and execution of the pathway, particularly with respect to timelines, operational accountability, and coordination with existing payment policies. Stakeholders are also likely to object vociferously to removal of the special provisions favoring breakthrough devices under the IPPS and the OPPS. &lt;/p&gt;
&lt;p&gt;Interested parties will be able to comment on both the forthcoming proposed RAPID notice and the IPPS Proposed Rule for FY27, which takes effect January 1, 2027. The comment window on the IPPS Proposed Rule is already open, and comments are due June 9, 2026. Arnold &amp;amp; Porter&amp;rsquo;s regulatory and reimbursement team will be following developments in this area, and we are available to consult about the proposals and possible comments.&lt;/p&gt;
&lt;/p&gt;
&lt;p&gt;&lt;span style="font-size: 13px;"&gt;&amp;copy; Arnold &amp;amp; Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.&lt;/span&gt;&lt;/p&gt;</a10:content></item></channel></rss>