Biotechnology and Biomanufacturing

After failing to be included in the Fiscal Year (“FY”) 2025 National Defense Authorization Act (“NDAA”) or passed as a standalone piece of legislation, the BIOSECURE Act has moved closer to finally being enacted after it was included in the final FY 2026 NDAA text released by Congress on December 7, 2025.  Section 851 of the FY 2026 NDAA is titled “Prohibition on Contracting with Certain Biotechnology Providers,” but includes in substance what was previously introduced and considered in Congress as the BIOSECURE Act. 

The bill has the potential to impose significant restrictions on the use of certain Chinese companies in the supply chain for products procured by the U.S. Government and accordingly has been of interest to industry over the last few years.  This blog post summarizes the scope of the bill, highlights the changes in the FY 2026 NDAA text as compared to prior iterations of the bill, and flags key considerations for government contractors in the life sciences space.Continue Reading BIOSECURE Act Moves Closer to Enactment with Inclusion in FY 2026 NDAA Text

The Department of Commerce recently released a new funding opportunity to support semiconductor-related research and development using funds appropriated under the CHIPS Act of 2022 (Pub. L. No. 117-167, 136 Stat. 1366 (Aug. 9, 2022)).  Set forth below are a few key considerations that interested applicants should bear in mind when evaluating this opportunity, including that the Department may expect to receive upside (e.g., equity stakes) in selected projects.Continue Reading U.S. Department of Commerce Opens New Funding Opportunity for Semiconductor R&D

The FY 2025 National Defense Authorization Act (“NDAA”) sustains Congress’s continued focus on countering China’s expanding influence and enhancing U.S. resilience in an era of great power competition.  This year’s legislation reflects the practice of carrying the State Department and Intelligence Authorization Acts within the NDAA—marking the third consecutive year that these critical measures have been advanced in tandem.  The Foreign Relations and Intelligence Committees in both chambers of Congress have increasingly adopted the Armed Services Committees’ playbook, embedding China-focused legislation modeled on past defense measures in their respective authorizations.  This blog examines key provisions designed to address what Congress views as strategic challenges posed by China while closing loopholes that could confer military, economic, or technological advantages to Beijing.  We divide these provisions into the following five categories:  (1) provisions that address potential security risks linked to Chinese-origin technology; (2) provisions that limit the transfer of U.S. technology or data to China; (3) so-called “time to choose” provisions that curtail Department of Defense (“DoD”) engagement with third parties that engage with China; (4) provisions that tackle a range of broader geopolitical concerns; and (5) studies and reports to identify emerging issues and concerns.
Continue Reading FY2025 NDAA: Congressional Efforts to Bolster U.S. Resilience Against Chinese Tech and Influence

Since its creation in 2006, the Biomedical Advanced Research and Development Authority has funded the development of medical countermeasures for pandemic influenza, anthrax, smallpox, Ebola virus disease, Zika virus, and, of course, COVID-19.  In just the last year, BARDA has made more than 35 new awards to partners, assisted its…

Continue Reading BARDA Announces New Solicitation Opportunities for 2024

It’s that time of year again: the House and Senate have each passed their respective version of the National Defense Authorization Act for FY 2024 (“NDAA”) (H.R. 2670, S. 2226).  The NDAA is a “must pass” set of policy programs and discretionary authorizations to fund Department of Defense (“DoD”) operations.  Lawmakers are currently undertaking the arduous process of reconciling these bills, while jockeying to include topics of importance in the final legislation.  The engrossed bills contain a number of significant provisions for defense contractors, technology providers, life science companies and commercial-item contractors – many of which we discuss briefly below and others that we will analyze in more depth in our NDAA series in the coming weeks.  Subscribe to our blog here so that you do not miss these updates.Continue Reading Key Topics to Watch as Congress Works to Fund Next Year’s DoD Budget

On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.  The White House subsequently announced that the Initiative would cost $2 billion.  If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle.  A summary of the E.O., its requirements, and key takeaways are set forth below.Continue Reading President Biden Issues Executive Order on National Biotechnology and Biomanufacturing Initiative