6505--JERRY - Radiopharmaceuticalsview on SAM.gov

The Department of Veterans Affairs, Networking Contracting Office (NCO 01) located in West Haven, CT, intends to enter into a sole source procurement with Novartis Pharmaceuticals Corporation for Lu-177 vipivotide tetraxetan (PLUVICTO). Authority: FAR 8.405-6(a)(1)(i) (items peculiar to one manufacturer), FAR 8.405-6(b) (limited-sources justification), MAS ordering authorities at 41 U.S.C. 152(3) and 40 U.S.C. 501, and GSAM/R 538.7104-3(b) as implemented for MAS sole-source justifications (RFO 8.4). STATEMENT OF WORK RADIOPHARMACEUTICALS Lu-177 vipivotide tetraxetan (PLUVICTO) is a radioligand therapeutic agent to perform the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive and metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy or have received prior taxane-based chemotherapy. Radiopharmaceutical preparation and delivery of Lu-177 vipivotide tetraxetan (PLUVICTO) doses performed at contractor facility provided by a board-certified radiopharmacist and delivered to the Nuclear Medicine Service at VA Connecticut Healthcare located at 950 Campbell Ave., West Haven, CT, building one, ground floor. Deliveries will be made Monday through Friday between 7:00 am and 3:00 pm. Personnel assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. A total of 74 doses of Pluvicto to treat prostate-specific membrane antigen (PSMA)-Positive. Contractor s employees will deliver to the PET/CT Service and give deliveries directly to the PET Technologist on duty. Delivery personnel will be bonded by the contractor. The contractor will provide for the placement of one or more telephone delivery order (s) per day for items listed in the Pricing and Cost Schedule, 24 hours per day, seven days a week, including holidays. Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. The offeror must provide copies of licenses and certifications along with a quote to the Contracting Officer. DELIVERY ORDERS: Due to the demands of the Medical Center care requirements, there shall be no restriction to the number of orders which may be placed by VA, nor the number of deliveries required per day. In the event that the requirements may be determined in advance, a longer delivery time will be scheduled accordingly. The delivery order shall specify contract item (s) and quantity, time (s) of delivery and applicable VA order number. Orders can be placed orally by telephone and/or online. DELIVERY LOCATION: VA Connecticut Healthcare System. 950 Campbell Ave. West Haven, CT 06516. PET Center and/or Mobile PET Unit; building one. Deliveries will be made Monday-Friday (excluding holidays which are listed…