75A50122C00047 JA Other Than Full and Open CompetitionRedacted.pdf

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

In 2009, BARDA issued a Request for Proposals (RFP-11-100-SOL-00007) to solicit proposals for the development of antivirals effective against smallpox. As a result of that solicitation, BARDA awarded contracts to the only two responders – a Project BioShield (PBS) contract (HHSO100201800019C) to SIGA Technologies, Inc. for the development and procurement of TPOXX® and an Advanced Research and Development (ARD) contract (HHSO100201100013C) to Chimerix, Inc. for the development of brincidofovir. Under the ARD contract that was awarded in February 2011, Chimerix, Inc. has achieved expected program goals as follows: brincidofovir has demonstrated effectiveness against variola virus in tissue culture and protective efficacy in FDA approved animal models of orthopoxviruses. With a period of performance that is ending in September 2021, to date, Chimerix, Inc. has completed late stage development including submission of an NDA application to the FDA for an estimated cost of $81M which is within the budget of the ARD contract. It is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

BARDA will continue to develop and acquire smallpox therapeutics to optimize preparedness against smallpox. At this time, no other company has a smallpox therapeutic with a mechanism of action distinct from that of TPOXX® and with an NDA accepted by the FDA. At the time of any future procurement, BARDA will issue a Sources Sought Notice in advance of the solicitation to maximize awareness of this opportunity and ensure all available candidates are identified.

6. Bridge Contracts:

N/A

7. Actions to Increase Competition:

BARDA issued a Sources Sought Notice in advance of the solicitation to maximize awareness of this opportunity and ensure “only one available source” is identified. An announcement will be posted on SAM.gov for 15 days prior to release of the solicitation to enable other Offerors to respond if they believe they have a technical solution that meets USG needs without undue delay or duplication of cost to USG.

This is a one-time requirement, but if a similar requirement for a third antiviral arises, every effort will be made to compete it to the maximum extent possible.

8. Market Research:

In 2009, BARDA issued an RFP to solicit proposals for the development of antivirals effective against smallpox. As a result of that solicitation, the government awarded contracts to the only two responders – a PBS contract to SIGA Technologies for the development and procurement of TPOXX® and an Advanced Research and Development (ARD) contract to Chimerix, Inc. for the development of brincidofovir.

BARDA continually conducts market research to identify candidates for development of smallpox therapeutics through the following methods: an open Broad Agency Announcement, attendance at scientific meetings, and communication with other USG entities that support MCM development (i.e. National Institute of Allergy and Infectious Diseases, Centers for Disease Control and Prevention, etc.). BARDA also consistently conducts outreach through an annual BARDA Industry Day to engage potential Offerors. Additionally, sponsors may request a TechWatch meeting with BARDA to present their MCM capabilities.

BARDA’s aggressive market surveillance is intended to ensure all potential sources have been identified and evaluated against this acquisition program’s objectives.

Small businesses were considered. A Sources Sought Notice was posted for both Small Businesses and Other Than Small Businesses. The only response received to either notice was from Chimerix, Inc.

Overall, based on proposals received over time in response to open solicitations, market surveillance, the posted Sources Sought Notice, and industry outreach, Chimerix's brincidofovir is the only product that meets all of the Government’s desired performance parameters.

9. Procurement History:

Purchase order or contract number: HHSO100201100013C

Was action competed? ✔ Yes

No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

N/A