Life Sciences Contracting

Life Sciences Contracting 101 2024

Life Sciences Contracting 101 will cover unique issues that companies in the life sciences industry face when dealing with products, technologies, or partners that receive support under U.S. Government agreements.  These issues can be relevant in a wide range of circumstances, such as when a company is selling products through the  U.S. Department of Veterans Affairs, licensing a technology subject to federal rights, or performing research and development with federal support.  Many companies may not even realize the extent of their ties to U.S. Government agreements through work with universities, licensors, or product sponsors.  In addition, more life sciences companies than ever are encountering U.S. Government agreements as a result of the COVID-19 pandemic.

Sessions will cover a number topics, including:

Session 1 – February 22

1. Schedule contracting and the prime vendor program
2. Pricing requirements under the Veterans Health Care Act of 1992
3. Subcontracting and small business requirements
4. The Office of Federal Contract Compliance Programs
5. Gift rules and lobbying
6. Sourcing and supply chain

Session 2 – February 29

1. The Bayh-Dole Act and other sources of U.S. Government of intellectual property rights
2. Emergency use authorizations, expanded access, and stockpiling authority
3. The Public Readiness and Emergency Preparedness or “PREP” Act
4. Indemnification and other liability protections
5. The Defense Production Act

Session 3 – March 7

1. The “Common Rule” for U.S. Government-supported clinical trials
2. Animal research requirements for U.S. Government agreements
3. Research involving recombinant or synthetic nucleic acid molecules
4. The Privacy Act and personally identifiable information
5. The Service Contract Act
6. Government property
7. Export controls, dual-use research of concern, and public access

Instructor: Tyler Evans, Steptoe