This is the second installment in a two-part series about the Biomedical Advanced Research and Development Authority's ("BARDA's") use of Broad Agency Announcements ("BAAs") to solicit industry proposals. BARDA (which falls under the purview of the U.S. Department of Health and Human Services) is the lead federal agency for supporting advanced development of medical countermeasures ("MCMs"). As discussed in part one of this article (published in our May 2015 Quarterly Update), BAAs provide a unique vehicle for soliciting proposals for advanced research and development – allowing BARDA to seek proposals related to broad areas of interest, rather than a predetermined statement of work. Part 35 of the Federal Acquisition Regulation defines a BAA as "a competitive solicitation procedure used to obtain proposals for basic and applied research and that part of development not related to the development of a specific system or hardware procurement." In part one, we provided an overview of the process of applying for and winning a contract or grant under a BAA. In part two, we continue to focus on BAA-13-100-SOL-00013 (BAA for the "Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear ("CBRN") Countermeasures for BARDA") ("CBRN BAA"). Most recently, BARDA awarded a contract worth up to $10.4 million to OraSure Technologies, Inc., to advance clinical development of its rapid Ebola antigen test under the CBRN BAA.
This article addresses specific requirements found in BARDA BAAs, using the CBRN BAA as an example.
- Unlike the typical solicitation, or grant application, in which the government dictates the intellectual property ("IP") rights it seeks, the CBRN BAA asks offerors to "describe any limitations in intellectual property . . . that will impact the Offeror's performance of the contract." This BAA requirement allows the government to assess any risks related to IP limitations during the proposal phase – including limitations posed by IP rights held by third parties. Contracts awarded under a BAA typically incorporate standard Federal Acquisition Regulation IP clauses.
- The CBRN BAA also states a preference for offerors providing U.S.-based jobs in technical and administrative fields. This preference is also included in the two other open BARDA BAAs.
- Under all BARDA BAAs, offerors must negotiate the terms of any grant or contract, including the type of agreement itself. The negotiation process can be extensive, and even include site visits and audits. An offeror may be removed from award consideration if the offeror and the government cannot negotiate mutually agreeable terms within a reasonable period of time.
- During the contract or grant administration phase, BAAs are further distinguishable from typical contracts. Unlike the typical "Changes" clause, BARDA BAAs require contractors to submit a "Deviation Report" to request a deviation from the contractor's "Integrated Product Development Plan." The Deviation Report must clearly set forth the justification or rationale for the requested change and present specific options to address the change – including a cost-benefit analysis, a timeline for each option, the contractor's recommended course of action, and a full analysis of how the proposed change affects the entire contract.
Contractors interested in submitting a white paper in response to a BARDA BAA (the first step in the process, as discussed in part one) should monitor FedBizOpps (www.fbo.gov). The deadline to submit white papers under all three open BARDA BAAs is July 30, 2015. Based on BARDA's historical record and current needs, it is likely that BARDA will extend or reissue those BAAs.
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