Smallpox Antiviral

Pre-solicitation Synopsis – Notice of Intent to Sole Source

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSALS.

This synopsis is hereby issued in accordance with FAR Part 5.203(a). The purpose of this synopsis is to announce that the Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to negotiate a hybrid Cost Plus Fixed Fee and Firm Fixed Price sole source contract with Chimerix Inc, located at 2505 Meridian PKWY STE 340, Durham NC 27713 for the development and procurement of a smallpox therapeutic with a mechanism of action distinct from that of TPOXX® and with an NDA accepted by the FDA.

The Government intends to negotiate solely with Chimerix, Inc. per FAR 6.302-1 as no other source will satisfy agency requirements. The development of antivirals against smallpox was deemed important and essential in the Institute of Medicine report Live Variola Virus, Considerations for Continuing Research with the panel emphasizing the need for the development of multiple countermeasures with distinct mechanisms of action to obviate the potential for the evolution of viral resistance through selective pressure.

Under an Advanced Research and Development (ARD) contract that was awarded in February 2011, Chimerix, Inc. has achieved the following with the development of brincidofovir, a smallpox therapeutic: demonstrated effectiveness against variola virus in tissue culture and demonstrated protective efficacy in FDA approved animal models of orthopoxviruses. With a period of performance that ended in September 2021, to date, Chimerix, Inc. has completed late stage development of brincidofovir, a smallpox therapeutic with a mechanism of action distinct from that of TPOXX® and received FDA approval.

The NAICS code for this acquisition is 541714, with a size standard of 1,000 employees. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No solicitation package will be issued through SAM.gov. This notice does NOT commit the Government to award a contract. This notice of intent is NOT a request for competitive quotations. However, responses received by 12/14/2021 4:30 PM Eastern Time will be considered.