1. JOFOC_redacted.pdf

This document is a Justification and Approval (J&A) for a sole source contract issued by the National Institutes of Health (NIH) Clinical Center. The contract is for Progenics Pharmaceuticals, Inc. to provide Pilufolastat F-18 injection (Pylarity™), a radiopharmaceutical for prostate cancer patient care, to the NIH Nuclear Pharmacy, Department of Radiology and Imaging Sciences. The contract is a continuation of a previous indefinite delivery/indefinite quantity (IDIQ) contract, with a performance period from October 1, 2025 to September 30, 2026, valued at $543,708.00.

Progenics Pharmaceuticals is the only FDA and US NRC approved supplier of this specific radiopharmaceutical, holding the exclusive patent. The contract is being awarded as a sole source procurement under FAR 6.302-1, citing that only one responsible source can satisfy the agency requirements. Extensive market research was conducted across multiple venues including GSA Advantage, System for Award Management, and other sources, which confirmed no alternative suppliers exist for this specific radiopharmaceutical product. The NIH plans to continue monitoring the market for potential new radiopharmaceuticals in future acquisitions.