6505--F-18 PSMA Pylarify

This is a notice of the Government s intent to award a sole source, open market Indefinite Delivery Contract (IDC) under 41 U.S.C. § 1901, as implemented by FAR 13.106-1(b)(2). The justification for the sole source action is the authority at FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The Veterans Integrated Service Network 6 (VISN 6) intends to negotiate a sole source IDC contract with Progenics Pharmaceuticals Inc. (doing business as Lantheus Medical Imaging, Inc.) for the supply and delivery of F-18 Pylarify (piflufolastat or 18F-DCFPyl). PYLARIFY is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: 1) with suspected metastasis who are candidates for initial definitive therapy, 2) with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The National Drug Code for F-18 Pylarify is 71258-0022-01. Progenics Pharmaceuticals Inc. (SAM UEI: YLYKVRPCTCR3) is the manufacturer of F-18 Pylarify which utilizes down-chain distribution partners for delivery to its customers. F-18 is only available for purchase through Progenics Pharmaceuticals Inc. All deliveries will be made to the Durham VA Medical Center (main facility) located at 508 Fulton Street, Durham NC 27705. A single award IDC contract will be awarded. The period of performance of the requirement will be from January 1, 2025 through December 31, 2025 with three (3) one-year option periods. The applicable NAICS code is 325412, Pharmaceutical Preparation Manufacturing (SBA Size Standard: 1300 employees). This Notice of Intent is not a request for competitive quotes. No solicitation documents are available and telephonic requests will not be taken. However, if a party believes it can meet the requirements to provide F-18 Pylarify it must furnish information about its products and services, as well as references from other customers who are using these products and services to the Contracting Officer by 05:30PM Eastern Time on Tuesday, December 10, 2024. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to perform the described work. Responses received will be evaluated, however; a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. After the closing date and time of this notice, if no other substantiated sources are identified, the Contracting Officer will proceed with the sole source negotiation with Progenics Pharmaceuticals Inc. (SAM UEI: YLYKVRPCTCR3). Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Daniel Spaulding at daniel.spaulding@va.gov. TELEPHONIC INQUIRIES WILL NOT BE ACCEPTED.