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In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global pandemic sparked by a coronavirus.  Additionally, the Secretary of the U.S. Department of Health and Human Services (HHS), issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability immunity for entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered medical countermeasures (MCMs).  Prioritized pathways are now available to expedite review of new, responsive technology proposals for MCMs from diagnostics to therapeutics.

In a previous post, we announced the Biomedical Advanced Research and Development Authority (BARDA)’s launch of an Easy Broad Agency Announcement (EZ-BAA) particularly created for the COVID-19 response.  Since then, BARDA has expanded the EZ-BAA’s scope to seek new diagnostic submissions.  In addition, BARDA narrowed the scope of a pre-existing BAA to prioritize areas of interest that support the novel coronavirus response.  Both submission opportunities are described in further detail below.

BARDA, under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS, continues to be the sole federal agency point of entry to expedite review and approval of COVID-19 proposal submissions.  In that capacity, BARDA continues to solicit market research packages and encourages interested stakeholders to submit their research on COVID-19 MCMs.  BARDA emphasizes that SARS-CoV-2, the virus that causes COVID-19, is the third coronavirus in less than 20 years, prompting the need for rapid development of responsive solutions.

We continue to monitor the legal, regulatory and commercial implications of COVID-19, and Covington has launched the COVID-19 Legal and Business Toolkit to help clients keep apprised of key developments.

Expanded EZ-BAA to Include Diagnostics

In February, BARDA announced new public-private partnerships to develop MCMs for COVID-19, including vaccine candidates and therapeutics for those already infected with SARS-CoV-2.  BARDA is continuing to seek submissions to create new public-private partnerships and has also broadened the possible responsive technologies to include “abstracts for nonclinical assays and models to support the development of multiple medical countermeasures.”  In addition to MCMs, BARDA is also prioritizing accurate, timely diagnostics.  To support that priority, a streamlined EZ-BAA for COVID-19 for molecular diagnostics is now available.  Key requirements include that diagnostic submissions must leverage FDA-cleared platforms and have a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.

The EZ-BAA will be open for submissions until March 18, 2020 at 5:00 PM EDT, unless otherwise extended.  Available awards are expected to be less than $750,000 per project.

Focused Areas of Interest for COVID-19 and SARS-CoV-2 Infection Response

On March 9, 2020, BARDA also adapted its pre-existing BAA to prioritize proposal submissions for COVID-19 response.  BARDA is focusing on the following areas of interest:

  • AOI 7.7.1 Diagnostic assay for human coronavirus using existing FDA-cleared platforms
  • AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus
  • AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)
  • AOI 8.3 COVID-19 Vaccine
  • AOI 9.2 COVID-19 Therapeutics
  • AOI 9.3 Immunomodulators or therapeutics targeting lung repair
  • AOI 9.5 Pre-exposure and post-exposure prophylaxis
  • AOI 10 Respiratory Protective Devices
  • AOI 11 Ventilators
  • AOI 17 Advanced Manufacturing Technologies

All other proposals for areas of interest unrelated to COVID-19 will be placed in a queue for later review.  The BAA is open to all responsible offerors, which include single entities or teams from private organizations, Government laboratories, and academic institutions.  Multiple awards of various values are anticipated dependent upon the program’s priorities and available funds, and BARDA may award any appropriate contract type under the FAR or Other Transactions Authority (OTA).  BAA Submission occurs in two stages:  Stage 1 requires submitting a Quad Chart and White Paper; Stage 2 requires submitting a Full Proposal.  For more information about the BARDA BAA submission process please visit ASPR’s website or the System for Award Management.  The submission deadline under this BAA is October 31, 2020.

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Photo of Jennifer Plitsch Jennifer Plitsch

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…

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.

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Photo of Sarah Schuler Sarah Schuler

Sarah Schuler is an associate in the firm’s Government Contracts Practice Group, advising clients across a broad range of government contracting compliance issues. Her areas of expertise include advising on intellectual property and data rights issues under the Federal Acquisition Regulation, including obligations…

Sarah Schuler is an associate in the firm’s Government Contracts Practice Group, advising clients across a broad range of government contracting compliance issues. Her areas of expertise include advising on intellectual property and data rights issues under the Federal Acquisition Regulation, including obligations imposed by the Bayh-Dole Act; application of the Freedom of Information Act to government contracts and related records; domestic sourcing requirements imposed under the Buy American Act and Trade Agreements Act; pricing and other compliance related issues arising under Federal Supply Schedule contracts; small business affiliation and certification analyses; the scope of flow-down requirements for subcontractors; and federal grant compliance under the Uniform Guidance and agency supplements. Sarah also counsels clients to navigate time-sensitive inquiries arising from contract compliance-related issues.

Sarah also maintains an active pro bono practice, providing counsel to U.S. service members with respect to the correction of military records and discharge upgrade requests.

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