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

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

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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