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Covington lawyers have particular expertise in advising pharmaceutical and biologics manufacturers on a broad-range of government contracting matters from research and development contracts and grants to supply contracts with the civilian and defense agencies of the federal government. Working in conjunction with our Life Sciences industry group colleagues, we advise clients on the entire contracting process starting with bidding and negotiation strategy, continuing through contract administration, compliance with FAR, HHSAR, GSAAR and other agency regulations, and contract modification and termination. We also represent drug and biological manufacturers in both pre-award and post-award protests, in investigations of potential contract violations, and in the contract claims process.
Our lawyers have specialized expertise in several topics that particularly impact life sciences contractors including:
- Federal Supply Schedule (“FSS”) contracting requirements (including, notably, the price adjustment and reduction obligations);
- Complex pricing and reporting requirements imposed on products under the Veterans Health Care Act (“VHCA”);
- Obligations imposed under the 340B and TRICARE programs;
- Country of origin requirements imposed by the Trade Agreements Act;
- Protecting intellectual property rights; and
- Obtaining adequate liability protection.
We regularly advise clients in the vaccine and biodefense industries in understanding the current procurement framework in these areas and in exploring contracting opportunities and complying with specialized contracting obligations. Finally, we advise on the issues that arise in the buying or selling of a life sciences company or product - including the diligence process, drafting of transactional agreements, and the transition of any relevant government contracts or grants pursuant to FAR or individual agency requirements.
Representative Matters
- Represented a contractor in competing for and performing various large research and development contracts for development of vaccine technology and domestic production capacity with the Department of Health and Human Services (“HHS”), as well as production contracts for various products with HHS, the Center for Disease Control, and state governments.
- Representation of a biologics manufacturer in analyzing pre-award and post-award protests and the pursuit and defense of claims under contracts with the U.S. government.
- Advice to a biodefense countermeasure manufacturer in negotiating key terms in contracts, including those governing liability protection, the use of intellectual property, and delivery terms.
- Advice to various pharmaceutical manufacturers regarding non-Federal Average Manufacturer’s Price and Federal Ceiling Price calculations for sales on the FSS contract administered by the Department of Veterans Affairs, as well as other questions arising in the performance of contracts under the VA Master Agreement.
- Advice to various manufacturers regarding obligations under the TRICARE Retail Pharmacy Program and submission of waiver requests pursuant to the Final Rule.
- Advice to a pharmaceutical manufacturer in analyzing 340B Program utilization and determining options for redress for suspected wrongdoing under that program.
- Provision of comprehensive training to a pharmaceutical manufacturer regarding compliance with VHCA pricing obligation to federal and 340B entities.
- Assisted a pharmaceutical manufacturer in investigating and analyzing potential price reduction clause violations under its VA FSS contract.
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