On June 8, 2026, the Department of War (“DoW”) published its updated list of “Chinese military companies” operating in the United States (“1260H List”), as required by Section 1260H of the Fiscal Year (“FY”) 2021 National Defense Authorization Act (“NDAA”).  The updated list includes, among other companies, WuXi AppTec Co., Ltd. (“WuXi AppTec”), a China-based contract research, development, and manufacturing organization utilized by many companies in the biotechnology industry.  This blog post discusses the anticipated impact of the updated 1260H List under the BIOSECURE Act and Section 805 of the FY24 NDAA and highlights the forthcoming implementation steps for these statutes.

1260H List

Section 1260H of the FY21 NDAA directs the Secretary of War to publish a list of Chinese military companies operating in the United States.  The statute defines a Chinese military company as an entity identified by the Secretary of War to meet the criteria in the statute based on ownership by, or relationship with, the Chinese military.  At the end of 2024, Section 1346 of the FY25 NDAA expanded the scope of “Chinese military companies” to include wholly owned or wholly controlled subsidiaries and affiliates of a Chinese military company or of an entity that owns in the aggregate, directly or indirectly, 50 percent or more of a Chinese military company.

BIOSECURE Act

As we covered in a previous post, the BIOSECURE Act, which was signed into law as Section 851 of the FY26 NDAA, prohibits executive agencies from procuring biotechnology equipment or services from biotechnology companies of concern (“BCOCs”), or using government loan or grant funding to procure, obtain, or use biotechnology equipment or services from a BCOC.  The statute directs the Office of Management and Budget (“OMB”) to publish, and periodically update, a list of BCOCs.  

The BIOSECURE Act defines BCOCs as including three categories:

  • Entities on the 1260H List,[1] if that entity is determined by OMB to be “to any extent involved in the manufacturing, distribution, provision, or procurement of any biotechnology equipment or service”; 
  • Entities included on a list to be developed by OMB (the “OMB List”) based on certain criteria set out in the statute; and
  • Any subsidiary, parent, or successor of a BCOC, if the subsidiary, parent, or successor is determined by OMB to meet the criteria set out for the OMB List.  (Notably, affiliate entities are not covered by the statute, although an affiliate entity of a BCOC could always be separately determined to meet the criteria to be named a BCOC.)

WuXi AppTec has filed a complaint challenging its inclusion on the 1260H List.  As of the date of this post, the case is pending in the U.S. District Court for the District of Columbia.

WuXi AppTec’s inclusion on the 1260H List means that the company is very likely to be designated as a BCOC by OMB.  If the company stays listed, the only remaining implementation step is for OMB to determine that WuXi AppTec is “to any extent involved in the manufacturing, distribution, provision, or procurement of any biotechnology or service,” a standard that the company is very likely to meet, given its activities (as well as the fact that WuXi AppTec was expressly named as a BCOC in earlier, but not enacted, versions of the BIOSECURE Act). 

Notably, the 1260H List only lists WuXi AppTec, and does not include other WuXi entities, some of which are also commonly used by companies in the biotech industry.  However, being explicitly named to the 1260H List is only one path to becoming a BCOC: it is possible that WuXi AppTec’s listing will be seen as encompassing wholly-owned or wholly-controlled subsidiary or affiliate companies (based on the 1260H List definitions noted above), and other WuXi entities could also be added to the OMB list to be published by December 18, 2026 – one year following the BIOSECURE Act’s enactment.

There are significant implementation steps still to come for BIOSECURE, including the publication of the OMB List and implementing guidance to be provided six months after the list is published.

Section 805 Restrictions

DoW’s publication of its updated 1260H List has brought attention to another set of procurement restrictions, enacted as Section 805 of the FY24 NDAA (“Section 805 Restrictions”).  While the BIOSECURE Act and the Section 805 Restrictions both reach entities on the 1260H List, the scope of each prohibition is distinct.

The Section 805 Restrictions, which apply only to DoW procurements, apply to entities on the 1260H List and any entity subject to the “control” of a 1260H List entity.  “Control” is given the broad definition at 31 C.F.R. § 800.208.

Under the Section 805 Restrictions, DoW is prohibited from (i) procuring goods, services, or technology from these entities (starting June 30, 2026) and (ii) procuring goods or services that include goods or services produced or developed by these entities (starting June 30, 2027).  It is unclear what it means to procure goods or services “that include” goods or services from a 1260H List entity, but the statute expressly exempts the procurement of components, suggesting that the prohibitions are intended to cover purchases of products from the restricted entities themselves, as well as purchases of products manufactured or developed by a restricted entity but sold by a third party.   

Section 805 of the FY2024 NDAA directs DoW to implement the Section 805 Restrictions by amending the Defense Federal Acquisition Regulation Supplement within 545 days of enactment, but the amendment process has not yet been initiated.  Accordingly, we do not have further guidance to understand the precise scope of the prohibition.

Even though DoW published its long-awaited updates to the 1260H List, there is a significant amount of uncertainty remaining around the implementation of the BIOSECURE Act and Section 805 Restrictions.  We will continue to monitor for updates regarding the BIOSECURE Act and the Section 805 Restrictions and report on them here.


[1] As noted above, the 1260H List is defined to “include[] a wholly-owned or wholly-controlled subsidiary or wholly-owned or wholly-controlled affiliate of such an entity or any entity that owns in the aggregate, directly or indirectly, 50 percent or more of any entity [designated under section 1260H].”  See Section 1260H(g)(2)(C) of William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, Pub. L. No. 116-283, as amended (codified at 10 U.S.C. § 113, note).

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch is a member of the Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative…

Jennifer Plitsch is a member of the Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

the Department of Veterans Affairs (VA);
the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

Photo of Jennifer Bentley Jennifer Bentley

Jennifer Bentley represents government contractors in a range of matters, with an emphasis on litigation, investigations, claims and disputes, and regulatory counseling. She also has deep expertise in government contracts domestic sourcing and supply chain issues, including the Buy American Act, Trade Agreements…

Jennifer Bentley represents government contractors in a range of matters, with an emphasis on litigation, investigations, claims and disputes, and regulatory counseling. She also has deep expertise in government contracts domestic sourcing and supply chain issues, including the Buy American Act, Trade Agreements Act, Build America, Buy America, and the BIOSECURE Act.

She has represented government contractors in False Claims Act investigations, prime-subcontractor disputes in federal court, disputes before the Armed Services Board of Contract Appeals, cost accounting disputes, and bid protests at the Government Accountability Office and U.S. Court of Federal Claims. She maintains an active pro bono practice.

Photo of Eunsun Cho Eunsun Cho

Eunsun Cho is an associate in the Government Contracts Practice Group. She assists clients on a range of regulatory and compliance issues.

Eunsun also maintains an active pro bono practice.