OTA

On September 4, DoD published a proposed rule updating the other transaction (OT) regulations set forth in 32 CFR part 3.  These updates are intended to implement various changes to the prototype OT statute (42 U.S.C § 4022) previously enacted by Congress.  Among other things, those changes included:

  • An expansion of the “appropriate circumstances” under which a prototype OT may be issued, to include situations involving participation by nonprofit research institutions, participation by small businesses, or opportunities “to expand the defense supply base”; and
  • Authority for DoD to issue follow-on “production” OTs on a sole source basis, provided that competitive procedures were used for award of the initial prototype OT.

Although these changes were already applicable to DoD as a matter of statute, the proposed rule would ensure that the CFR is aligned with the statute and that the regulations provide accurate guidance. More details are below.Continue Reading DoD Rolls Out Proposed Changes to Prototype OTA Regulations

It’s that time of year again: the House and Senate have each passed their respective version of the National Defense Authorization Act for FY 2024 (“NDAA”) (H.R. 2670, S. 2226).  The NDAA is a “must pass” set of policy programs and discretionary authorizations to fund Department of Defense (“DoD”) operations.  Lawmakers are currently undertaking the arduous process of reconciling these bills, while jockeying to include topics of importance in the final legislation.  The engrossed bills contain a number of significant provisions for defense contractors, technology providers, life science companies and commercial-item contractors – many of which we discuss briefly below and others that we will analyze in more depth in our NDAA series in the coming weeks.  Subscribe to our blog here so that you do not miss these updates.Continue Reading Key Topics to Watch as Congress Works to Fund Next Year’s DoD Budget

Defense Department leaders and agencies have been granted much-needed flexibility to respond to the coronavirus pandemic.  Last week, Under Secretary of Defense for Acquisition & Sustainment Ellen Lord delegated approval authority for Other Transaction Agreements (“OTs”) related to the coronavirus response, consistent with Section 13006 of the CARES Act.
Continue Reading Other Transaction Authorities Given Greater Flexibility to Foster Innovation in Coronavirus Response

Registration will open soon for the Biomedical Advanced Research and Development Authority’s (“BARDA”) 2018 Industry Day to be held on October 29 and 30 at the Grand Hyatt in Washington, D.C. This event has been an integral part of BARDA’s outreach efforts to the life sciences community since 2007, and the newest version of this event promises to continue to provide meaningful insight into BARDA’s role in the nation’s public health preparedness efforts.

BARDA is expected to revisit annual topics like revisions to its broad agency announcement and updates to its goals and Government-wide strategic plans. In addition, this year BARDA will have a particular focus on innovation with the rollout of its Division of Research, Innovation, and Ventures (“DRIVe”) and lightning talks on noteworthy development efforts. Applications to participate in lightning talks are due soon, and potential participants should consider whether to take advantage of this unique opportunity.Continue Reading Save the Date – BARDA Industry Day Is Coming

On February 7, the Department of Defense (DoD) awarded REAN Cloud a contract valued at up to $950 million to work with defense agencies to migrate existing applications to commercial cloud solutions. The award is of significant relevance to efforts currently underway in connection with the upcoming DoD Joint Enterprise Defense Infrastructure—or “JEDI”—procurement. However, the award is also important in a broader context in that it was issued as a follow-on production contract to an “other transaction” (OT) prototype agreement awarded on an expedited basis by DoD’s Defense Innovation Unit Experimental organization (DIUx). The award, therefore, reflects DoD’s increased comfort with issuing high-value production contracts following preliminary work with DIUx under OT prototype agreements.
Continue Reading DIUx and DoD Other Transaction Prototype Agreements: The Fast Track to DoD Funding

Last week, the Defense Advanced Research Projects Agency (“DARPA”) issued a new broad agency announcement (“BAA”) seeking proposals to support the creation of an integrated “capability platform” for the delivery of medical countermeasures to prevent a pandemic threat within sixty days of targeting a known or newly emerging pathogen.  The BAA confirms DARPA’s commitment to addressing national security concerns raised by both naturally occurring public health emergencies and bioterrorism, as well other biological threats to members of the U.S. military.  Learning from recent experiences with Ebola, Zika, and Middle East respiratory syndrome, DARPA is targeting prophylactic solutions that are designed to prevent or halt the spread of an infectious outbreak, rather than solutions intended solely or primarily to treat infected individuals.

DARPA’s approach is consistent with recent guidance from the President’s Council of Advisors on Science and Technology in that it focuses on platform technologies and processes, which represent general approaches to medical countermeasure development that can be rapidly and reliably applied to varying threats.  The Biomedical Advanced Research and Development Authority has adopted a similar focus in its own platform-based BAA, and additional opportunities for platform development will likely arise in the near future under the most recent strategy and implementation plan of the Public Health Emergency Medical Countermeasures Enterprise.Continue Reading DARPA Seeks to Establish New Platforms for Rapid Development of Medical Countermeasures