Statement of Work - Lutathera and Pluvicto - Draft

STATEMENT OF WORK

Lebanon VA Medical Center
Lutetium (Lu177) Dotatate and Lutetium (Lu177) PSMA
Title of Project: Procurement and Delivery of radioactive material in the form of Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to the Lebanon VAMC.

Scope of Work: Norvartis Pharmaceuticals Corporation referred to as the contractor shall provide name brand Lutathera (lutetium Lu 177 dotatate) and name brand Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to the Lebanon VA Medical Center as outlined in the SOW. The contractor shall perform to the standards in the contract and meet all necessary Federal regulatory requirements and guidelines.

Background: Lutathera (lutetium Lu 177 dotatate) is for the treatment of patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is for the treatment of adult patients with prostate-specific membrane antigen (PSMA)- positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI) and are considered appropriate to delay or have had taxane-based chemotherapy.

The VA Medical Center in Lebanon, PA, is establishing a contract to meet the need for delivery, storage, inventory management, packaging and shipment preparation, distribution and transportation of Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in support of the VA Medical Center Nuclear Medicine needs.

It is the intent of this contract to have a supply of Lutathera and Pluvicto readily available for shipment/transportation and continuous Inventory Management Services and equipment during normal working hours as described in this Statement of Work. Offerors shall furnish and deliver F.O.B. Destination all items as listed in the “Schedule of Supplies and Services” and others that may be needed in the future. When applicable, preference will be given to contractors who supply products from non-High Enriched Uranium sources (non-HEU).

Contractor must be able to show evidence of reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) at the scale and frequency necessary to meet this