Subscribe

  • How Can We Help You?

    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Plitsch_Jennifer_1000x714_ENV

Jennifer L. Plitsch

Partner

Washington +1 202 662 5611

  • About
  • Representative Matters
  • Credentials
  • About

    Jennifer Plitsch leads the firm’s 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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters

    Biodefense and Research and Development Contracting

    • Representation of clients in over $30 billion of contracts to develop and supply vaccines, therapeutics, diagnostics, and medical devices in response to the COVID-19 pandemic.
    • Representation of clients in obtaining DoD and HHS funding for facility construction and expansion for the domestic manufacture of vaccines, therapeutics, diagnostic tests, and key related components.
    • Advised clients regarding special indemnity protections related to COVID-19, including PREP Act coverage.
    • Representation of contractor in competing for, and performing, various research and development contracts for development of vaccine technology and domestic production capacity with HHS as well as production contracts for various vaccine products with HHS, CDC, and state governments.
    • Provided dozens of clients with assistance through multiple phases of contracting and development covering vaccines and therapeutics for Ebola, Zika, pandemic influenza, MERS, SARs, and other infectious diseases and advice to clients on public-private partnerships covering similar threats, as well as man-made threats associated with potential terrorist attacks including nerve gases, anthrax, and radiation.
    • Assisted clients at multiple tiers of contracting in connection with particular projects by negotiating both primary agreements with U.S. government laboratories or agencies and subagreements with public or private entities extending from pre-clinical and clinical research agreements to drug or biologic supply agreements, material transfer agreements, and standard service subcontracts.

    Intellectual Property

    • Advising federal contractors and grantees regarding domestic manufacturing requirements, background rights, march-in, patent infringement, and public disclosure issues including advising clients in responding to pressure from third-party groups requesting the government assert price controls or additional intellectual property rights.
    • Representation of pharmaceutical manufacturer in assessing substantial domestic manufacturing obligations under the Bayh-Dole Act and obtaining a waiver of such requirements.
    • Representation of pharmaceutical manufacturers in assessing march-in risks under the Bayh-Dole Act for products receiving federal funding during the development stage.
    • Advising on FAR and Defense Acquisition Regulations System (DFARs) intellectual property and data rights obligations in contract formation and performance and after contract completion.

    FSS Contracting

    • Represented top pharmaceutical, biologics, diagnostics, and medical device manufacturers in disclosures and negotiations with the VA on a variety of complex issues including: the calculation of non-FAMP and FCP prices, the treatment of complex, multi-component products under the Price Reduction Clause; recognition of modified products as “new” drugs for purposes of Veterans Healthcare Act (VHCA), acceptance of new pricing methodologies and allowance of discretionary price increases for products regulated under the VHCA.
    • Advice to various manufacturers regarding compliance under the TRICARE and 340B programs including price and rebate calculations and contract pharmacy issues.
    • Advice regarding the application of the TAA to various complex pharmaceutical and drug-device combination products, and the implications of the Acetris ruling.

    Other Representative Matters

    • Advice to foreign biodefense contractor in diligence review and acquisition of U.S. biodefense manufacturer.
    • Advised major pharmaceutical company in the sale of multiple businesses involving significant U.S. Government contracts on issues relating to novation, subcontracting, secondment, intellectual property, and reimbursement of costs.
    • Representation of contractor in federal trial and appellate court litigation regarding novel issues arising under the Contract Disputes Act.
    • Negotiation and resolution of cost issues under federal contracts and grants for research and development.
    • Advice to pharmaceutical manufacturers regarding ethical constraints in interactions with government officials and healthcare providers, and assistance with establishing internal compliance policies.
    • Representation of government contractor in challenging release of various contract information under the Freedom of Information Act.
    • Provided dozens of clients with advice on various aspects of the CARES Act, including with respect to paycheck protection loans, assistance through cost-reimbursement agreements, and the impact of tax provisions on government contracting.

    Areas of Expertise

  • Credentials
    Education
    • Harvard Law School, J.D., 1996
        •  cum laude
    • Drew University, B.A., 1993
        • summa cum laude with specialized honors in Political Science
    Bar Admissions
    • District of Columbia
    • Pennsylvania
    Government Experience
    • U.S. Department of the Treasury
    Judicial Clerkship
    • Hon. Anne Thompson, U.S. District Court, District of New Jersey, 1996 - 1998
    Pro Bono
    • Providing advice to the Washington Humane Society regarding the negotiation and performance of its contract with the D.C. Government.
    • Representation various nonprofit contractors in negotiating and complying with government contracts, subcontracts and grants.
    • Successful representation of two African American Farmers in claims of discriminatory lending practices against the United States Department of Agriculture.
    • Successful representation of a putative class of inmates in challenging the use of five-point restraints in a Virginia state correctional facility.
    Accolades
    • Law360, Life Sciences MVP (2020)
    • Legal 500 US, Government Contracts (2016-2018)
    • Washington DC Super Lawyers, Government Contracts (2014-2020)
    • Charles F.C. Ruff Pro Bono Lawyer of the Year (2001)
    Previous Experience
    • United States Department of the Treasury, General Counsel’s Office (General Law and Ethics and Enforcement Sections), Honors Attorney (1998-1999)

    Areas of Expertise

News and Insights

Events