Kristen Riemenschneider represents life sciences companies, from global pharmaceutical companies to start-up biotechs, in a broad range of transactions. Her practice focuses on the negotiation of agreements for the research, development, and commercialization of pharmaceutical and biologic products, including license and collaboration arrangements, research and commercial manufacturing and supply arrangements, clinical trial agreements, materials transfer agreements, sponsored research agreements, and other commercial transactions.
In addition to her commercial transactions work, Ms. Riemenschneider also counsels life sciences and other companies that engage in US Government-funded research and development. Her work includes counseling on the Bayh-Dole Act, the Stevenson-Wydler Act, and the scope of protection afforded federal contractors under 28 U.S.C. s 1498. Ms. Riemenschneider has also negotiated intellectual property-centric agreements (including CRADAs, TIAs and OTAs) with various agencies including NIH, NCI, BARDA, NIAID and DoD.
Ms. Riemenschneider has a degree in engineering and is a registered patent attorney.
- AstraZeneca in agreements for the funding and global distribution of the University of Oxford's potential COVID-19 vaccine as well as the establishment of its global manufacturing and supply chain for the vaccine, including agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance (Gavi), the Serum Institute of India (SII), the Biomedical Advanced Research and Development Authority (BARDA) in the US, and the governments of Germany, France, Italy, and the Netherlands.
- Sanofi in a long-term research collaboration with Kymera Therapeutics to discover, develop and commercialize first-in-class protein degrader therapies for patients with immune-inflammatory diseases for $150 million upfront and more than $2 billion in potential milestones plus royalties.
- AstraZeneca in the negotiation of a multi-target research collaboration with Silence Therapeutics to discover, develop and commercialise small interfering RNA (siRNA) therapeutics for the treatment of Cardiovascular, Renal, Metabolic and Respiratory diseases. The transaction reflected a deal value of $4 billion in development and sales milestones, as well as tiered high single digit to low double digit royalties.
- Omada Health in a long-term strategic collaboration with Abbott Diabetes Care to integrate Abbott's continuous glucose monitoring (CGM) technology with Omada's professional coaching and digital care platform, aiming to create a new paradigm for people with Type 2 diabetes.
- Aduro Biotech in the negotiation of a research collaboration and exclusive license agreement with Eli Lilly & Company for Aduro's cGAS-STING Pathway Inhibitor program for the research and development of novel immunotherapies for autoimmune and other inflammatory diseases.
- AstraZeneca in the negotiation of an exclusive research collaboration and licensing agreement to co-develop five engineered oncolytic vaccinia virus candidates with Transgene, a French biotech company.
- Novartis, in the negotiation of license and supply agreements with Spark Therapeutics for ex-US development and commercialization of Luxturna, the first approved gene therapy for an inherited disease. The transaction reflected a deal value of $170 million in achievable milestones as well as royalties.
- Novartis, in the negotiation of an investment with Blackstone for the formation of Anthos Therapeutics, and the related license of MAAA868, an anti-coagulant, to Anthos.
- Novartis, in the negotiation of a supply agreement for the EU production of Kymriah, the first CAR-T cell therapy approved by the United States Food and Drug Administration (FDA).
- Insmed Incorporated, in the negotiation of a license and collaboration agreement with AstraZeneca regarding an early-stage respiratory drug. The transaction reflected a deal value of $150 million in achievable milestones and double-digit royalties.
- Idera Pharmaceuticals, in the negotiation of a license and collaboration agreement with GSK regarding the modulation of gene targets. The transaction reflected a deal value of 100 million.
- Churchill Pharmaceuticals in the negotiation of a license of YONSA, a novel formulation of abiraterone acetate, to Sun Pharmaceuticals, and the negotiation of related manufacturing and supply arrangements.
- OPKO Health, in a license and development agreement with Pfizer for a long-acting human growth hormone (hGH-CTP) for adults and children. The deal terms included a $295 million upfront payment, an additional $270 million in milestones, and royalties and a profit share.
- Omada Health, in the negotiation of various commercial arrangements pertaining to Omada's mHealth applications.
- Aduro BioTech in the negotiation of various commercial arrangements pertaining to ongoing clinical trials.
- Bruin Biometrics in the negotiation various commercial arrangements pertaining to ongoing clinical trials.
- JD, University of Virginia School of Law
- BSEE, Electrical Engineering, University of Virginia
- District of Columbia
- US Patent and Trademark Office
- United States Court of Federal Claims, The Honorable Francis Allegra
Member, Programs Committee, Women in Technology (WIT)
Vice Chair, Intellectual Property Committee, ABA Public Contract Law Section
Member, ABA Science & Technology Law Section
Member, ABA Intellectual Property Law Section
Member, National Defense Industrial Association (NDIA)
- Extensive pro bono work, including representing individuals in civil disputes and in seeking public assistance, and representing organizations in corporate formation, obtaining tax-exempt status, and various commercial transactions