5 Year BPA for Pluvicto and Lutathera

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SUPPLY CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), intends to award a firm fixed price five (5) year Blanket Purchase Agreement (BPA) for Radiopharmaceutical Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Lutathera (lutetium Lu 177 dotatate) Injections for use in the Nuclear Medicine Division at Naval Medical Center San Diego (NMCSD) in accordance with the Federal Acquisition Regulation (FAR) 13.501(a) Sole Source acquisitions and FAR 13.1061(b)(1)(i), only one source being available to meet the Government’s needs, to:

Advanced Accelerator Applications USA Inc. 57 Willow ST Millburn, New Jersey 07041-1416, United States The North American Industry Classification System (NAICS) code for this requirement is 325412 - PHARMACEUTICAL PREPARATION MANUFACTURING - In-Vitro Diagnostic Substance Manufacturing; the business size standard is 1300 (in employees). The Product Service Code (PSC) is 6505 - DRUGS AND BIOLOGICALS.

The objective of this sole source award is to procure Advanced Accelerator Applications USA Inc of off the U.S. Department of Veteran Affairs Federal Supply Schedule (FSS) contract number 36F79719D0169 National Drug Code (NDC) 69488-0003-01 Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) National Drug Code (NDC) 69488-0010-61.

Radiopharmaceutical Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Lutathera (lutetium Lu 177 dotatate) injections for Nuclear Medicine Division at Naval Medical Center San Diego (NMCSD). The Nuclear Medicine Division urgently requires Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Lutathera (lutetium Lu 177 dotatate) injections for emergency treatments.

Period of Performance: 1 November 2024 to 31 October 2029 Advanced Accelerator Applications USA Inc. is the only source that can meet the Government’s minimum requirements to provide the requested supplies and reagents mentioned above at NMCSD. This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement.

Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required customized implant for NMCSD. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government.

A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Cha-on. P. Gordon at cha-on.p.gordon2.civ@health.mil The closing date for challenges is no later than 1000 Pacific Daylight Time, Thursday, 5 September 2024. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.