A02 - JA_Redacted_03.03.2025.pdf

This is a Justification and Approval (J&A) document for a sole source acquisition under FAR 13.501 for the Defense Health Agency (DHA) and U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The document justifies a Firm Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contract with a 5-year ordering period to Mapp Biopharmaceutical, Inc. in San Diego, CA for human-derived monoclonal antibodies (mAbs) and viral recombinant antigens (Ags) using RDT&E funds.

The requirement supports therapeutic efficacy testing against Machupo Virus (MACV), Crimean Congo Hemorrhagic Fever Virus (CCHFV), and Hantavirus infections. The products were co-developed with USAMRIID under contract W81XWH-21-C-0121 and Mapp Biopharmaceutical holds exclusive intellectual property rights. The period of performance runs from June 30, 2025 through June 29, 2030 across a base period and four option periods. A Notice of Intent for this sole source award will be published on SAM.gov for 15 days. Market research determined this requirement is not appropriate for small business set-aside as no other vendors can provide these proprietary products and Mapp Bio has no authorized resellers.