Morrison Foerster’s Government Contracts Insights provides our in-depth analysis of developments and trends impacting government contracting. Through Insights, our attorneys offer a real-time assessment of the statutory, regulatory, legal, and business-related developments and trends that are shaping the industry. We also examine a full array of non-U.S. public procurement issues, mindful that our clients compete in a global marketplace.Morrison Foerster’s nationally recognized Government Contracts and Public Procurement practice represents the world’s leading companies in the aerospace and defense, intelligence, cybersecurity, information technology, financial and professional services, education, healthcare, infrastructure, and logistics support sectors. We are enlisted to address our clients’ most complex and important legal issues. Our work includes contract and subcontract negotiation and other transactional matters, business and regulatory compliance counseling, internal investigations, bid protests, and a wide array of enforcement and litigation matters. Our clients range from Fortune 50 companies to small and medium-sized companies just entering the public sector. We advise both U.S. and non-U.S. companies involved in municipal, state, federal, and non-U.S. procurement matters.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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GAO Protest Timeline

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Govcon GAO Post Award Protest Timeline Article

Contract Disputes Act Claim Timeline

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The Bayh-Dole Act

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Anatomy of a Protest

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Allowability of Legal Costs

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Procurement Integrity Act

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Tina is Co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmaceutical companies, with a focus on general contract counseling and compliance, particularly concerning intellectual property, and cybersecurity matters and federal grant funding.Tina counsels contractors on compliance with federal, state and local acquisition and ethics regulations and with the evolving myriad of requirements pertaining to data security and cybersecurity. She has been involved with numerous internal investigations and compliance reviews, and with mandatory and voluntary disclosures to agencies, and litigation of False Claims Act matters.Tina routinely advises clients concerning:<ul><li>Prime-subcontractor relationships</li><li>Sources of supply and country of origin requirements</li><li>Price reductions and price reporting issues</li><li>Organizational conflicts of interest</li><li>Safeguarding of intellectual property and other proprietary interests</li><li>Licensing and data rights issues</li><li>Handling of classified materials and controlled unclassified information</li><li>Agency suspension and debarment proceedings</li></ul>She also assists clients with due diligence and other activities related to the acquisition of government contracting concerns, and with the drafting and negotiation of teaming agreements, subcontracts, licensing agreements, and cooperative research and development agreements. She also assists clients applying for federal grants (including SBIR and STTR agreements), and those who seek to obtain other transactional authority agreements, as well as those competing for state and local government work.Tina’s litigation experience includes government contracts claims litigation in federal courts and before boards of contract appeals, bid protests before the Government Accountability Office and the Court of Federal Claims, and complex disputes in federal courts, including civil fraud and False Claims Act litigation and reverse Freedom of Information Act litigation.Prior to joining Morrison Foerster, Tina worked at another large national firm and as a trial attorney in the Office of the General Counsel of the Navy, Navy Litigation Office.<h4>Representative Experience</h4><ul><li>Negotiation of largest CHIPS Act federal funding agreement between multinational semiconductor corporation and U.S. Department of Commerce.</li><li>Negotiated prime contract and major subcontracts related to the Department of Energy’s next generation supercomputer program, including extensive IP rights negotiations and negotiation of associated patent rights waivers.</li><li>Negotiated series of other transaction authority agreements with DARPA and associated subcontracts with more than a dozen research universities on behalf of a firm biotech client, including complex IP rights allocations and material transfer agreements.</li><li>Assist clients with FedRAMP authorization process and with development of license agreements for software products sold to federal, state and local government agencies.</li><li>Cyber incident response counseling to some of the largest companies and organizations impacted by security incidents.</li><li>Advises clients on Bayh-Dole reporting of inventions and IP strategies for contracts and grants.</li><li>Conducts due diligence for major government contract mergers and acquisitions.</li></ul>

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Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

Jim Tucker is of counsel in Morrison Foerster’s Government Contracts and Public Procurement Practice Group and is based in the firm’s Washington, D.C. office.Jim’s practice runs the gamut of litigation and counseling in federal procurement matters, with an emphasis on bid protests, Cost Accounting Standards disputes, and small business matters. He has represented both protesters and awardees in scores of protests before the Government Accountability Office, the Court of Federal Claims, and procuring agencies, in acquisitions ranging from small business procurements to multibillion-dollar contracts of global significance. His representative protest matters span the aerospace sector, the Intelligence Community, base operations and logistics, healthcare, nuclear and environmental work, and information technology and software acquisitions. His protests have included both classified and unclassified programs. In addition to prevailing in published decisions, Jim has also secured favorable corrective action on behalf of clients in a wide variety of protests that were resolved without a published decision.Jim’s work also focuses on disputes over cost allowability and compliance with the Cost Accounting Standards, and he has appeared before the Armed Services and Civilian Boards of Contract Appeals, in size and status protests before Small Business Administration (SBA) area offices, and appeals before the SBA Office of Hearings and Appeals. Jim regularly counsels clients on contract interpretation, organizational conflicts of interest, and small business compliance.Jim graduated with high honors from the George Washington University Law School, where he focused his studies on federal procurement law, was a member of the Law Review, and interned with the General Services Administration’s suspension and debarment office. Jim also holds a degree in theology magna cum laude from the Pontifical Gregorian University in Rome and a bachelor’s degree in classical languages and literature summa cum laude from the University of Kentucky, where he graduated Phi Beta Kappa.

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Jim maintains an active practice in bid protests before the Government Accountability Office and contracting agencies and counsels clients in contract disputes and compliance obligations.

Jim Tucker is of counsel in Morrison Foerster’s Government Contracts and Public Procurement Practice Group and is based in the firm’s Washington, D.C. office. Jim’s practice runs the gamut of litigation and counseling in federal procurement matters, with an emphasis on bid protests, Cost Accounting Standards disputes, and small business matters.

James Tucker

<div style="margin-bottom: 15px;" class="videoWrapper"><iframe class="sticky-video" title="Meet Alex Ward, Government Contracts Practice Co-Chair" src="https://www.youtube-nocookie.com/embed/TkliwdSlTaQ?rel=0" frameborder="0" allow="autoplay; encrypted-media" allowfullscreen="1" title="iframe"></iframe></div>J. Alex Ward is co-chair of Morrison Foerster’s Government Contracts and Public Procurement group. His practice covers a full range of government contracts matters, including investigations, bid protests, claims, general litigation, corporate transactions, and counseling. Alex strives in all matters is to provide his clients the highest level of efficient and effective representation.Alex represents contractors in internal and external investigations, disclosures to the government, and qui tam litigation, with great success in reducing or eliminating his clients’ exposure through active engagement with the government. His work in this area includes obtaining numerous declinations and dismissals of False Claims Act cases in their earliest stages, sparing his clients the cost, risk, and exposure of litigation.He has also served as lead counsel in dozens of bid protests involving military and civilian agency procurements of a wide range of products and services, including all manner of pre- and post-award protests in the GAO, the U.S. Court of Federal Claims, and state tribunals, as well as appeals to the U.S. Court of Appeals for the Federal Circuit and size protest appeals before the SBA’s Office of Hearings and Appeals.Alex handles all aspects of the claims process, from the initial assessment and drafting of requests for equitable adjustment through litigation in the Boards of Contract Appeals and the Court of Federal Claims. Alex’s practice also covers the full gamut of other controversies confronting government contractors, including prime-sub, teaming partner, employer-employee, competitor, and indemnification disputes. His litigation work also includes a wide variety of pro bono engagements, in which he has represented both individual and institutional clients in matters ranging from immigration and criminal defense to sustainable procurement and protection of the environment.Prior to joining the firm, Alex served in the U.S. Army as a commissioned officer and an Assistant to the General Counsel of the Army responsible for civil works and international matters, and as a clerk for judges on the U.S. Courts of Appeals for the Armed Forces and the D.C. Circuit. He is a member of the Boards of the Morrison & Foerster Foundation and the Chesapeake Bay Foundation and of Law360’s Government Contracts Editorial Board.

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Alex is co-chair of Morrison Foerster’s Government Contracts and Public Procurement practice. His practice covers a full range of government contracts matters, including bid protests, claims, investigations, corporate transactions, and counseling.

J. Alex Ward

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Morrison Foerster’s Government Contracts Insights blog provides an in-depth analysis of news, developments, and trends impacting government contracting and procurement. Through Insights, attorneys from our nationally recognized Government Contracts and Public Procurement practice will offer a real-time assessment of the statutory, regulatory, legal, and business-related developments that are shaping the industry. This blog will also examine a full array of U.S. and non-U.S. public procurement issues, mindful that our clients compete in a global marketplace.Read about our <a href="http://govcon.mofo.com/editors/">Authors</a>.Never miss a post. Subscribe to get real-time updates.

Brad is a partner in Morrison Foerster’s Litigation Department, Managing Partner of the Austin office, and Chair of the firm’s Israel practice. He is the former Co-Chair of the firm’s Global Litigation Practice and the Government Contracts + Public Procurement Practice.

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James A. Tucker

The Tortured Regulations Department: SBA’s New Rule and Its Effect on Investments

Bid Protest Spotlight: Standing, Relationships, Responsibility

House’s Passage of the SAMOSA Act Signals Policy Shift Towards Government-Wide Enterprise Software Licensing

New DFARS Regulation on Small Business Affiliate Past Performance

Bid Protest Spotlight: Unclear Criteria, Data Rights, Conflicts

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New Agency Sets Ambitious Goals to Transform Biomedicine and HealthAs part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the <a href="https://www.nih.gov/arpa-h">Advanced Research Projects Agency for Health</a> (ARPA-H). Authorized by Congress in March 2022, the new agency will bring together industry, academia, and government through public-private partnerships for high-risk, high-reward endeavors intended to drive breakthroughs in biomedicine and health. ARPA-H seeks to capitalize and expand on recent advances in biomedicine to revolutionize the prevention and treatment of cancer, infectious diseases, and Alzheimer’s and other diseases, and potentially to uncover cures. Its impact on Americans could be profound.  Among the <a href="https://www.whitehouse.gov/wp-content/uploads/2021/06/ARPA-H-Fact-Sheet.pdf">potential early projects</a> that ARPA-H has identified are efforts to develop mRNA cancer vaccines, wearable blood pressure and blood sugar monitors, and systems to help eliminate racial disparities in maternal morbidity and mortality. The agency’s focus is very broad, and it intends to leverage its unique position to fill gaps across the United States’ biomedical research ecosystem. The breadth of innovation that the agency plans to undertake is, in part, the byproduct of a series of <a href="https://www.whitehouse.gov/ostp/news-updates/2021/08/17/white-house-and-national-institutes-of-health-close-out-listening-sessions-with-over-5100-stakeholders-on-the-proposed-advanced-research-projects-agency-for-health/">listening sessions</a> that the White House and National Institutes of Health (NIH) held last year, which included more than 5,100 stakeholders.Structurally, ARPA-H is an independent agency within NIH in the U.S. Department of Health and Human Services. The agency will model its approach to the award of grants and contracts on the process used by the Defense Advanced Research Projects Agency (DARPA). With the <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/12/president-biden-announces-intent-to-appoint-dr-renee-wegrzyn-as-inaugural-director-of-advanced-research-projects-agency-for-health-arpa-h/">inaugural director recently announced</a>, one of the agency’s next priorities will be identifying a diverse cohort of program managers, assembled from industry, academia, and other sectors, to implement the agency’s vision. Like DARPA, ARPA-H plans to seek broad, flexible funding authority and to use an adaptable and permissive proposal review process. While the specific parameters of the process are still in development, an analogy may be the process used by the Biomedical Advanced Research and Development Authority (BARDA), another agency within the HHS, which we described in detail in <a href="https://lifesciences.mofo.com/topics/us-government-new-federal-funding-opportunities-related-to-covid19">this article</a>.As the new agency takes shape, it remains clear that it has the strong backing of the Biden Administration. President Biden’s proposed fiscal year 2023 budget included $5 billion for ARPA-H—a notable increase over the $1 billion that Congress allocated in 2022. Somewhat relatedly, the administration further demonstrated its commitment to biotechnology and biomanufacturing by issuing an <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/">Executive Order</a> in September 2022 on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” which introduces the National Biotechnology and Biomanufacturing Initiative. While the Initiative’s mission goes beyond that of ARPA-H―including climate change, energy, food security, agriculture, supply chains, and national security in addition to health―the EO is further evidence of increasing investment in biotechnology research and development and manufacturing capabilities.We will continue to monitor the development of ARPA-H, and will provide further updates as opportunities for biotech and health companies to partner with the agency, and to receive funding to further its ambitious goals, become available.Cody Kornack, a Law Clerk in our Washington, D.C., office, contributed to the writing of this alert.

U.S. Government Launches Billion-Dollar Biomedical Agency

Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

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U.S. Government Launches Billion-Dollar Biomedical Agency

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H).

The Biomedical Advanced Research and Development Authority (<a href="https://www.medicalcountermeasures.gov/">BARDA</a>), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies seeking to develop products designed to diagnose, prevent or treat coronavirus infections.Current OpportunityOn March 4, 2020, BARDA revised a pre-existing BAA to solicit proposals for COVID-19 diagnostic tests, vaccines, medicines such as therapeutics or antivirals (to either help prevent or to treat infections), and respiratory devices and ventilators.  A further revised version, BAA‑18‑100-SOL-00003, Amendment 14, was issued on March 9, 2020.  The current BAA requests COVID-19 related proposals by April 30.  (The BAA also has subsequent submission dates of July 31 and October 31, 2020, with the latter being the latest possible submission date for this BAA.)The Areas of Interest included in the amended BAA are:<ul><li>AOI 7.7.1 Diagnostic assay for human Coronavirus using existing FDA-cleared platforms</li><li>AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus</li><li>AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)</li><li>AOI 8.3 COVID-19 Vaccine</li><li>AOI 9.2 COVID-19 Therapeutics</li><li>AOI 9.3 Immunomodulators or therapeutics targeting lung repair</li><li>AOI 9.5 Pre-exposure and post-exposure prophylaxis</li><li>AOI 10 Respiratory protective devices</li><li>AOI 11 Ventilators</li><li>AOI 17 Advanced Manufacturing Technologies</li></ul>Initial proposals are to take the form of a “Quad Chart” and a brief White Paper.  Quad charts must follow this format and include a visual depiction and description of the effort, objectives, benefits, milestones, and other requested information.  The White Paper is intended to provide a brief technical discussion of the offeror’s objective, approach, level of effort, and the nature and extent of the anticipated results.  (The full Quad Chart and White Paper requirements are described in the BAA-18-100-SOL-00003, Amendment 14, beginning at page 62.)Related Government EffortsBARDA is also facilitating a parallel, consolidated U.S. government <a href="https://www.medicalcountermeasures.gov/app/barda/coronavirus.aspx">website</a> for companies to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.  According to the site, it is intended as “a portal for the U.S. government 2019 novel Coronavirus (2019-nCoV) medical countermeasures task force to provide a single point of entry for the submission of market research packages from interested stakeholders.”In addition, BARDA opened a special, expedited broad agency announcement, an EZ-BAA, seeking diagnostics that use platforms already cleared by the FDA, such that these products could be authorized for use in as soon as 12 weeks.  If the government can identify products and technologies that have progressed beyond non-clinical studies, have established domestic large‑scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and have utilized a platform used to manufacture a product already approved by the FDA, that will significantly expedite time to market. Relatedly, the U.S. Food and Drug Administration (FDA) has issued two <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorizations</a> (EUA) of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and the NYS Wadsworth Center.  An EUA is a unique authorization that enables the FDA to authorize otherwise unapproved products for use in a public health emergency.  That emergency was officially declared on February 3, 2020, opening the door for EUA submissions and authorizations to deal with the COVID-19 pandemic.  In addition, FDA also issued a <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics">new policy</a> on February 29 to help expedite the availability of diagnostic tools created laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to develop or offer high complexity tests.In addition, we understand that at least two companies are currently developing Coronavirus vaccines with assistance from BARDA and that another is working with the government on a treatment for people who are already sick.Additional BackgroundFor those unfamiliar with the organization, BARDA is a federal sub-agency tasked with the procurement and development of countermeasures against bioterrorism (also including chemical, nuclear, and radiological threats), as well as pandemic influenza and emerging diseases.  BARDA regularly publishes a series of BAAs through which it seeks submission of proposals at set intervals over a period of time from industry and research centers with novel ideas about ways to fight bioterrorism and disease.  BARDA evaluates these initial proposals and then selects those that it would like to pursue further.Eventually, awards of various values are made, based upon program priorities, proposals’ scientific/technical merits, how well the proposals fit BARDA’s areas of interest, and available funds.  Awards may be in the form or cost-reimbursement or other cost-based funding, or BARDA may award grants or make use of its Other Transaction Agreement (OTA) authority to issue that type of agreement.The BAA process generally proceeds as follows, although BARDA has indicated that the process may be altered somewhat during this unprecedented time:<ol><li>Company submits initial proposal by dates specified in BAA. (BARDA generally accepts proposals only four times per year).</li><li>Within 90 days of receipt of the initial proposal, BARDA notifies the company whether it would like a more detailed, Full Proposal.</li><li>The company prepares and submits a Full Proposal in accordance with the BAA instructions.</li><li>Within 180 days, BARDA either accepts the Full Proposal or reverts to the company with additional questions.</li><li>Once BARDA’s questions are answered, it asks the company to submit a Final Proposal Revision (“FPR”).</li><li>Assuming the FPR is acceptable, the FPR will be incorporated by reference into the final contract, OTA or grant. If BARDA has further questions, it will ask again and request another FPR.</li><li>If the parties agree to the FPR, a final agreement is presented by BARDA to the company, and the company will review and sign.  Sometimes contract or grant terms and conditions may be negotiated at this stage (if the company is unwilling or unable to accept the agreement as written), although most of the terms and conditions are non-negotiable in that they are statutory or regulatory requirements or otherwise considered mandatory by BARDA.</li></ol>Our Morrison & Foerster team has extensive experience assisting clients in responding to BAAs and negotiating contracts, grants, and OTAs.  We can provide guidance as to which type of vehicle may be most appropriate, and assist with compliance considerations for those companies without significant federal contracting experience or appropriate cost accounting and Federal Acquisition Regulation (FAR) compliance systems.  On the FDA front, we are actively engaging with FDA on the EUA process and advising clients on their diagnostic test development.  We can help with FDA communications, understanding inter-relationship among public health agencies, and assessing the opportunities presented for new product development in light of the COVID-19 pandemic. Please contact the authors for further information.

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U.S. Government Announces New Federal Funding Opportunities Related to COVID-19

Updated Coronavirus (COVID-19) Guidelines For Employers

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The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary f

U.S. Government Announces New Federal Funding Opportunities Related to COVID-19

A variety of arcane domestic-preference regimes apply to many Federal procurements – the Buy American Act (BAA), the Trade Agreements Act (TAA), the Berry Amendment, and the Cargo Preference Act, to name a few.  In <a href="https://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-2399.Opinion.2-10-2020_1529718.pdf">Acetris Health, LLC v. United States</a>, the Court of Appeals for the Federal Circuit recently denied a Government appeal and clarified the test used to determine if a pharmaceutical product – or any other product – is compliant with the TAA.  This significant decision rejects the longstanding analytical approach used by U.S. Customs and Border Protection (CBP) for pharmaceuticals as well as the reliance of the Department of Veterans Affairs (VA) on the CBP’s judgment for purposes of Federal procurement.The Governing LawTwo statutes are the source of most restrictions on the Government’s ability to procure supplies of foreign origin:  the BAA and the TAA.The rules governing whether the BAA or TAA applies to a particular procurement are fairly confusing, and the analysis required to determine BAA compliance is quite different from the analysis for TAA compliance, and neither is particularly intuitive.  The BAA was designed to keep foreign products from competing on an equal footing with American-made products.  The Federal Circuit has succinctly summarized the main features of the BAA:The first of these statutes to be enacted, the Buy American Act of 1933 (“BAA”), provides in relevant part that:[O]nly manufactured articles, materials, and supplies that have been manufactured in the United States substantially all from articles, materials, or supplies mined, produced, or manufactured in the United States, shall be acquired for public use unless the head of the department … determines … their cost to be unreasonable.41 U.S.C. § 8302(a)(1) (emphasis added). A 1954 Executive Order, now implemented in the FAR, specifies that the unreasonable cost exception to the BAA applies where the lowest domestic offer by a large business is over 6% higher than the lowest foreign offer, and the lowest domestic offer by a small business is over 12% higher than the lowest foreign offer. 48 C.F.R. (“FAR”) § 25.105.  Congress has also exempted commercial-off-the-shelf (“COTS”) products from the “substantially all” requirement, 41 U.S.C. § 1907, so a COTS product “manufactured” in the United States is BAA-compliant even if it is manufactured from predominantly foreign components, FAR § 25.101(a)(2).Thus, the BAA considers both an end product’s component articles, materials, and supplies (unless it is a COTS item) and the end product’s place of manufacture, and has a built-in exception applied via a price premium analysis.The TAA is far more recent and, when it applies, provides an exception to the BAA.  The Federal Circuit explained the TAA in this way:The second of these statutes is the TAA.  The TAA was designed to encourage foreign countries to enter reciprocal government-procurement trade agreements.  Those agreements prohibit foreign countries from discriminating against American-made products and prohibit the United States from discriminating against foreign-origin products.  Under the statute, countries that have entered into such agreements, and that do not discriminate against American-made products, are allowed to compete for U.S. government procurements on non-discriminatory terms.  At the same time, products from countries that have not entered into such trade agreements are barred from government procurements.  Countries that have entered into such agreements are described as parties to the World Trade Organization (“WTO”) Agreement. …The TAA generally prohibits the procurement of “products of a foreign country or instrumentality” that is not party to the WTO agreement or otherwise “designated” by the President for purposes of the TAA.  19 U.S.C. § 2512(a)(1).  The TAA’s country-of-origin test defines “a product of a country” as:An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.19 U.S.C. § 2518(4)(B) (emphasis added).  Note that, although a finding that an article is the “product” of a non-designated foreign country generally precludes the Government from procuring it, the statute does not require that the Government affirmatively determine that an article is a “product” of the United States or a designated country as a prerequisite to a procurement of that article.The FAR implements the TAA in regulation and harmonizes it with the BAA.  As relevant here, the FAR’s Trade Agreements clause provides that a contractor shall “deliver under this contract only U.S.-made or designated country end products.”  FAR 52.225‑5(b).  The FAR defines “U.S.-made end product” as:U.S.-made end product means an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.FAR 52.225-5(a) (emphasis added).  Note that, unlike the BAA, the TAA and its implementing clause do not require an analysis of the country of origin of a manufactured item’s components.  Note also that, unlike the country of origin definition in the TAA’s statutory text, the FAR does not use the adverb “wholly” when discussing where an article is mined, produced, or manufactured.Factual BackgroundThe protester, a contractor to the VA and other agencies, was a distributor of generic pharmaceuticals.  As relevant here, the protester supplied Entecavir tablets (used to treat hepatitis B) that were manufactured in New Jersey, using an active pharmaceutical ingredient that was made in India.  India is not a “designated country” subject to preferential treatment under the TAA and its implementing regulations.During performance of a prior contract, the VA “requested” that the protester seek country-of-origin determinations from CBP for certain of its products, including Entecavir, as the VA had been informed that the protester may be supplying drugs that were not TAA-compliant, as required by its contract.  CBP, following its own longstanding practice, determined that Entecavir was a product of India because the pharmaceutical’s active ingredient was made in India and allegedly no substantial transformation had occurred in the United States.  The protester accepted a no-cost cancellation of its incumbent contract to avoid a termination for default.The VA then issued a new solicitation for Entecavir, again subject to the TAA.  In response to a question by the protester, the VA stated that CBP’s prior determination was final and therefore any Entecavir made with an Indian-origin active ingredient would be deemed non-compliant with the TAA and unacceptable.  The protester filed a timely pre-award protest, challenging the VA’s interpretation of the TAA and arguing “its products, though manufactured using foreign-made [active ingredients], are not ‘products of’ India (under the TAA) and are ‘U.S.-made end products’ (under the FAR) because they are manufactured into tablets in the United States.”The Court of Federal Claims agreed with the protester, and the Government appealed.  The Federal Circuit concurred with the result of the lower court’s decision, while adjusting the analysis and remedy.StandingBefore reaching the merits of the protest, the Court addressed an interesting question of standing.  Notwithstanding its pending protest, the protester submitted a proposal in response to the challenged solicitation.  The Government showed that the protester’s proposed price was the highest received, in a procurement conducted on a lowest price technically acceptable basis.  Because the protester had no chance at award, even if its tablets were found to be TAA‑compliant, the Government moved to dismiss the case on the basis that the protester suffered no injury-in-fact, the case was moot, and the protester lacked standing to protest.The Court agreed with the Government that the protester no longer had standing to challenge the current solicitation in light of a price that precluded it from award.  The Court found, however, that the VA was “virtually certain” to conduct similar procurements in the future and, absent the VA’s erroneous application of the TAA, the protester was “very likely” to bid on those procurements.  The Court noted that the Court of Federal Claims had jurisdiction over suits objecting to “any alleged violation of statute or regulation in connection with a procurement or a proposed procurement,” and that its own precedents held that “‘in connection with’ is very sweeping in scope.” the Court held that the protester had standing with respect to future procurements expected in the relatively near future.  The Court found that the protester had a substantial chance of securing future contracts for similar products and that the VA’s stated interpretation of the TAA caused the protester a “non-trivial competitive injury.”  Therefore, the protester was an interested party with standing to bring the protest.MeritsAddressing the merits of the protest and the Court of Federal Claims’ analysis, the Federal Circuit first rejected the Government’s argument that CBP’s country-of-origin determination was binding on the VA.  The Court held that it is the procuring agency, not the CBP, that is “responsible for determining whether an offered product qualifies as a U.S.-made end product.”  Contrary findings of the CBP are entitled to no deference.The Court also rejected the Government’s argument (which repeated the CBP’s finding) that the protester’s Entecavir tablets were products of India because that was the country of origin of the tablets’ active pharmaceutical ingredient.  The Court held that the “product” at issue here – and the only thing regulated by the TAA – was “the pill itself,” not the pill’s various ingredients.  The tablet itself was not a “product of India” because the tablet was not “wholly the . . . manufacture” of India, nor was it “substantially transformed” in India, as provided in the TAA’s country-of-origin test.  19 U.S.C. § 2518(4)(B).  Because the statutory country-of-origin test applies only in the negative – i.e., prohibiting procurement of products of a non-designated country, but not also requiring that the product be found to be a product of the United States or another designated country – the Court held that the statute did not bar the protester’s product:  “Accordingly, since the TAA only excludes products from government procurement if they are ‘products of’ a foreign country like India, the TAA does not bar the VA from procuring Acetris’ products.”Turning next to the FAR’s Trade Agreements clause, the Government argued that the tablets were not compliant because they were neither “wholly” manufactured in the United States, and manufacturing the final tablets in New Jersey did not “substantially transform” the Indian active ingredient into a new product.  This argument required the Government to read the adverb “wholly” from the statutory country-of-origin test, where it is present, into the FAR’s Trade Agreements clause, where it is not present.  Nor, for that matter, is the adverb “wholly” present in the BAA or its regulatory implementation, either.The Court noted that the Trade Agreements clause defines “U.S.-made end product” as “an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States.”  FAR 52.225-5(a) (emphasis added).  The Court reasoned that, regardless of whether manufacturing the tablets substantially transformed the Indian ingredients into a new product, the definition of a compliant end product included any product that is “manufactured in the United States,” which the Entecavir tablets indisputably were, regardless of the source of their ingredients and other components:A product need not be wholly manufactured or substantially transformed in the United States to be a “U.S.-made end product.” Instead, such products may be—as Acetris’ products are—“manufactured” in the United States from foreign-made components.(Emphasis added.)  Given the fact of domestic manufacture, the Court found it unnecessary to decide the separate question of whether the tablets also were substantially transformed in the United States.  The FAR says either prong is enough to render an end product “U.S.-made” and thus compliant with the Trade Agreements clause.  Therefore, under the TAA and its implementing regulations in the FAR, the VA incorrectly determined that the protester’s Entecavir was non-compliant with the TAA and its regulatory implementation in the FAR.The Court concluded its merits discussion by observing:  “If the government is dissatisfied with how the FAR defines ‘U.S.-made end product,’ it must change the definition, not argue for an untenable construction of the existing definition.”The Court remanded the matter to the Court of Federal Claims, with instructions to adjust the relief granted, including a permanent injunction applicable to future procurements:On remand, the Claims Court should declare that: (1) under the TAA, a pharmaceutical product using [active pharmaceutical ingredients] made in India does not, because of that fact, thereby become the “product of” India; and (2) under the FAR, the term “U.S.-made end product” may include products manufactured in the United States using [active pharmaceutical ingredients] made in another country.  The Claims Court should also enjoin the VA from excluding Acetris’ products manufactured in Aurolife’s Dayton, New Jersey facility from future procurements.Takeaways<ol><li>The rules for analyzing and applying the various domestic-preference regimes can be complicated and counter-intuitive, with requirements that change from one regime to the next, and a variety of exceptions and exceptions to the exceptions. If an offeror or contractor is unsure of its compliance obligations, it is prudent to seek legal counsel to navigate the labyrinth.</li><li>The Federal Circuit sidestepped an argument that was central to the litigation at the Court of Federal Claims: whether a product that is BAA-compliant (as the protester’s was here) is necessarily also TAA-compliant.  The protester argued (and the Court of Federal Claims concluded) that it was; the Government argued that it was not.  In a footnote, the Federal Circuit found that analysis was irrelevant.  As a practical matter, though, it is difficult to imagine a situation where an item would be BAA-compliant but not TAA-compliant under the holdings of this decision.</li><li>The Federal Circuit has provided helpful guidance by clarifying that, so long as an end product is not “wholly the . . . manufacture” of or “substantially transformed” in a non-designated country, and is either “mined, produced, or manufactured in the United States [or other designated country] or . . . substantially transformed in the United States [or other designated country],” it is TAA-compliant. This is a far simpler test to apply than the one the VA attempted to impose.</li><li>This decision’s only direct effect is on Federal procurements. The decision will not bind any agency for non-procurement purposes, such as country-of-origin determinations in connection with tariffs and other import duties.  It remains to be seen whether CBP will accept the Federal Circuit’s analysis as persuasive authority in those non-procurement arenas and alter its country-of-origin analysis in general and as applied to pharmaceuticals.  Suppliers that previously have unquestioningly relied upon CBP determinations for procurement purposes may wish to rethink that approach in light of Acetris.</li><li>The Federal Circuit accepted the Court of Federal Claims’ finding that the process of converting Entecavir’s active pharmaceutical ingredient and other constituents into the final tablet form was “manufacturing” for purposes of the FAR’s Trade Agreements clause. Under both the BAA and the TAA, however, it is not always easy to determine where an end product was “manufactured,” and that potential complication will remain even under the Federal Circuit’s simplification of the TAA analysis.</li><li>Potential offerors should scrutinize the domestic-preference provisions appearing in solicitations and, like the protester here, ask questions early and be prepared to protest before the date set for the receipt of proposals. If an offeror fails to object to improper solicitation terms before that time, any later protest of those terms generally will be dismissed as untimely.</li></ol>

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Damien is a partner in the firm’s Government Contracts & Public Procurement practice. He represents clients in all facets of government contracts transactions, as well as regulatory counseling, subcon

Damien Specht

Damien C. Specht

Jim Tucker is of counsel in Morrison & Foerster’s Government Contracts and Public Procurement Practice Group and is based in the firm’s Washington, D.C. office.
Jim’s practice runs the gamut of litiga

Trade Agreements Act Compliance: Federal Circuit Clarifies Country of Origin and Place of Manufacture Analyses

A variety of arcane domestic-preference regimes apply to many Federal procurements – the Buy American Act (BAA), the Trade Agreements Act (TAA), the Berry Amend

Trade Agreements Act Compliance:  Federal Circuit Clarifies Country of Origin and Place of Manufacture Analyses