6505--PLUVICTO-Novartis

The Department of Veterans Affairs, Networking Contracting Office (NCO 01) located in West Haven, CT, intends to enter into a sole source procurement, pursuant to the authority of FAR 6.302-1, with Novartis Pharmaceuticals Corporation for the following requirement:

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 12 doses of Pluvicto for 2 patients 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 below) between the hours of 7:00 AM and 3:00 PM.

Federal Holidays are as follows and include any other days specifically declared by the President of the United States to be deemed a holiday.

New Year s Day

Juneteenth

Thanksgiving

Martin Luther King s Birthday

Independence Day

Veterans Day

Presidents Day

Columbus Day

Christmas

Memorial Day

Labor Day

Access to the VAMC location during non-business hours shall be obtained by contacting the AOD located in the Emergency Department who will contact VA Police to accompany the delivery Person to the PET Center and supervise the delivery.

Deliveries will be supervised by the COR or their designee before beginning delivery operations. The contractor will contact the COR prior to delivery to arrange for delivery supervision.

DELIVERY COMMITMENT:

Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

PERIOD OF PERFORMANCE:

The contract will have a Period of Performance from 8/1/2025 to 7/31/2026.

SUPPLIES OR SERVICES AND PRICES/COSTS:

Contractor to provide Radiopharmaceutical product, PLUVICTO, as requested by authorized VA Staff, to support the West Haven campus of VA Connecticut Healthcare System (VACHS), 950 Campbell Ave, West Haven, CT 06516.

PERSON AUTHORIZED TO PLACE ORDERS:

In addition to the Contracting Officer, the COR is authorized to place orders under this contract, as well as any Certified Nuclear Medicine Technologist employed by the West Haven VA Hospital.

NOTIFICATION:

The services specified herein may be changed by written modification. The modification will be prepared by the VA Contracting Officer.

The NAICS code for this requirement is 325412.

Novartis Pharmaceuticals Corporation is the only contractor capable of providing PLUVICTO. Novartis Pharmaceuticals Corporation is the sole Food & Drug Administration (FDA) approved source of this highly specialized therapeutic radiopharmaceutical, PLUVICTO (Lutetium Lu-177 Vipivotide Tetraxetan)

This notice of intent is not a solicitation nor is it a request for proposal. However, interested parties that believe they can satisfy the requirement must clearly identify their capability to do so in writing by Monday, July 28, 2025, at 12 pm EST time. Response should be sent to Jerry Choinski at Jerry.Choinski@va.gov. Information submitted in response to this notice will be used solely to determine whether competitive procedures could be used for this acquisition. A determination not to open this requirement to competition based upon responses to this notice is solely within the discretion of the Government.