On January 19, the Defense Advanced Research Projects Agency (“DARPA”) issued a new solicitation in the form of a broad agency announcement for the Preventing Emerging Pathogenic Threats—or “PREEMPT”—program. The program will be managed by the DARPA Biological Technologies Office, which generally supports activities that integrate biology, engineering, computer science, physical sciences, and mathematics.

The goal of the program is to support research and development relating to new tools, models, and technologies that are focused on preventing the transition of viral threats from animals to humans. In contrast to recent biodefense efforts that have largely been initiated in response to significant human outbreaks, such as in connection with Ebola, influenza, and Zika, the program targets animal-based viruses that have yet to become an active threat to humans. In addition, consistent with DARPA’s mission, the program targets animal-based viruses that have a potential to impact deployed U.S. military forces, particularly with respect to remote geographic areas associated with prevalent endemic and emerging diseases.

Solicitation Requirements

The solicitation requires offerors to address two related technical areas, including:

  1. an assessment of the likelihood that a selected animal-based virus, or multiple related viruses, will jump to humans in a targeted geographic area; and
  2. methods for suppressing the virus either in a typical animal host or a potential vector for transmission to humans, such as livestock or mosquitos.

The solicitation suggest that gene editing, antibodies, defective interfering particles, and vaccination may ultimately present viable solutions. However, the solicitation also strongly encourages offerors to identify novel approaches. In addition, the solicitation encourages offerors to pursue approaches that do not require individual treatment of animals and only activate in the presence of a targeted virus.

Offerors will need to demonstrate that they have the capacity to conduct field trials in a targeted geographic area, including with respect to necessary infrastructure and host-country approvals. In addition, offerors will need to provide a technology transition plan detailing expected efforts to transition a proposed solution to governmental, private, or non-profit partners. Consistent with the broad scope of contemplated activities, the solicitation encourages teaming among offerors.

Award Terms

Awards may ultimately take the form of procurement contracts, grants, cooperative agreements, or “other transaction authority” agreements. However, regardless of form, awards will likely have a 42-month period of performance with a 24-month base period and an 18-month option period.

Depending on the nature of proposed solutions, awardees may need to comply with dual use research of concern and gain-of-function policies during performance. In addition, DARPA expects that bioethical and biosafety issues will need to be continually monitored.

Data generated under each award may need to be shared between awardees or with the broader research community. As a result, the solicitation indicates that awardees will be expected during performance to make all generated data available to DARPA and may need to provide data to other awardees under appropriate data-sharing agreements.

Although the solicitation does not specifically identify DARPA’s expectations with respect to data rights, it indicates that DARPA may seek permission to share generated data with the public. Accordingly, to the extent that a standard data rights regime does not apply to a particular agreement, DARPA may expect to receive at least the equivalent of “government purpose rights” that are typically applied under procurement contracts with the U.S. Department of Defense.

Solicitation Schedule

The solicitation process is scheduled to be relatively brief. A conference for potential offerors is planned for January 30, and abstracts and full proposals are respectively due by February 13 and March 27.

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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.