DAP-00000113_2026-07-31_ASPR_DAP-00000113_2026-06-29_ASPR_01 HHSO100201700016C JA Other than Full and Ope.pdf

This is a Justification and Approval (J&A) for Other Than Full and Open Competition document for a modification to an existing federal contract.

The acquisition seeks procurement of Ebola virus therapeutics for the Strategic National Stockpile (SNS) under a modification to existing Contract Number HHSO100201700016C with Regeneron Pharmaceuticals Inc., located at 777 Old Saw Mill River Road, Tarrytown, NY 10901. The contracting agency is the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services. The modification is valued at $297,715,850.15, with the original award valued at $693,056,926.67, bringing the total contract value to $990,772,776.82. The pricing structure is hybrid cost-plus fixed fee and firm-fixed price. The acquisition year is FY 2026, and no OMA or PBS funds are allocated.

The justification for sole-source procurement is based on FAR 6.103-1 (only one responsible source), citing that Inmazeb (regneron's Ebola therapeutic) is the only FDA-approved product meeting government requirements and SNS storage standards. The product must demonstrate efficacy against Ebola virus in animal models, possess an acceptable safety profile, be compatible with SNS storage and packaging, meet cGMP manufacturing standards, and maintain product consistency. The modification will support manufacture and delivery of up to 26,500 doses through 2031; USG preparedness for Ebola outbreaks addressing a requirement for 753,000 therapeutic treatment courses; and technology transfer and FIH/finish process support. Market research confirmed that Inmazeb and Ebanga are the only FDA-approved Ebola therapeutics as of January 2026, with Ebanga unavailable for procurement until 2028. The contract was originally awarded in 2017 following competitive RFP procedures and has been actively performed. All required approvals including legal review, competition advocate review, OSDBU review, and HCA approval have been obtained.