A02. JA FAR Part 13.5- Cryoplateable Hepatocytes IDIQ Redacted_Redacted.pdf

This is a Justification and Approval (J&A) document for a sole-source acquisition under Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii) for commercial items. The contracting activity is the US Army Medical Research Acquisition Activity (USAMRAA), Contracts Group 1, Contracts Branch 1. This is a follow-on requirement to contract W81XWH21D0004 and will be awarded to BioIVT, LLC on a sole-source, firm-fixed-price basis for an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with an ordering period from December 18, 2025, through December 17, 2030.

The requirement is to acquire up to 250 units of Rhesus monkey or cynomolgus macaque monkey cryoplatable hepatocytes per year and up to 100 units of male or female human cryoplatable hepatocytes from BioIVT, LLC. The justification establishes that only BioIVT possesses the unique capability to provide certified cryoplatable hepatocytes that support the Plasmodium cynomolgi assay at Walter Reed Army Institute of Research (WRAIR), which is the only validated assay of its kind in the world for anti-malarial activity testing. Market research conducted from February 14 through May 27, 2025, confirmed no other vendor can meet the requirement, as all identified competitors use sub-par, unvalidated hepatocytes that would render the assay ineffective. An RFI posted on GSA Advantage and SAM.gov from July 3–14, 2025, and a Notice of Intent from July 16–31, 2025, generated no competing capability statements or responses. The statutory authority for the sole-source acquisition is 41 U.S.C. 1901 as implemented in FAR 13.501(a)(1)(ii). The estimated contract value and type of funding are redacted in the document.