SOW - Lutathera and Pluvicto - DRAFT.docx

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 requirement.

Performance Period: The Government is requesting a one (1) year contract.

· POP: January 1, 2027 to December 31, 2027.

Type of Contract: Firm-Fixed Price

Point of Contact: Delivery shall be coordinated with the designated Point of Contact (POC):

· To Be Determined

Note: The POC has no authority to change the terms and conditions of the awarded contract.

GENERAL REQUIREMENTS

1. The dose regimen of Lutathera (lutetium Lu 177 dotatate) is 200mCi intravenous injection with a total of 4 injections given at 8week intervals.

2. The dose regimen for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is 200mCi intravenous injection with a total of 6 injections given at 6week intervals.

3. The contractor will package and deliver individual unit dose for each patient on the date and calibration time specified when order was placed so that the administered quantity is within regulatory limits of the prescribed dose.

4. All routine radiopharmaceutical dose deliveries must occur more than one hour prior to the calibration time. In the event that Nuclear Medicine is unable to perform a patient procedure due to dose/injection arriving in an unusable form (eg activity too low), the vendor will not furnish an invoice for the dose.

5. No delivery charge shall be required for additional deliveries during normal working hours.

6. Contractor shall provide an adequate supply of contract products to meet the requirements of Lebanon VA Medical Center.

7. Contractor shall label all supplies as to the type and amount of radiopharmaceutical, lot number, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into a nuclear medicine information management system.

8. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

9. Contractor shall hold a current unrevoked Nuclear Regulatory Commission (NRC) and/or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material, and FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide copy of their radioactive material license with their proposal.

10. Contractor shall immediately notify the Contracting Officer and Contracting Officer Representative, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license.

11. Contractor shall meet all applicable Nuclear Regulatory Commission (NRC), VA/ National Health Physics Program (NHPP), Department of Transportation, FDA, OSHA requirements and all other agency rules and regulations (Federal and State) related to the supply of Radiopharmaceuticals. Contractor must maintain all certifications throughout the performance of contract.

12. Contractor shall provide evidence of special driver’s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State).

13. The contractor shall maintain an effective Quality Control program to ensure services are performed in accordance with the SOW. All products shall be tested for Quality Control by the supplier and only those products that pass Quality Control may be sent to the Lebanon VA Medical Center. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of testing upon request. All products are purchased subject to acceptance by the Lebanon Medical Center. Products that fail to meet Quality Control criteria will not be accepted. Products will be rejected and may be discarded if found unsatisfactory when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials.

14. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee.

15. All defective or inferior products shall be replaced within the timeline specified at no costs to the VA.

16. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government.

17. It is the Contractor’s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer and the Nuclear Medicine Contracting Officer Representatives Amy Landis or Jae Nayati utilizing the most expedient method.

18. It is the Contractor’s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer and the Nuclear Medicine Contracting Officer Representatives Amy Landis or Jae Nayati utilizing the most expedient method.

19. Consultation service regarding Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge.

Returns/Credits:

1. Contractor shall accept returns for credit under the following conditions:

a. Product(s) shipped in error.

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

2. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: a Licensee may use for medical use only:

a. By-product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State.

b. Reagent kits that have been manufactured, labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

3. Contractor must adhere to the provisions of Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI) as required by complying with rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veteran Affairs.

4. Contractor will provide Lebanon VAMC personnel access to relevant online and /or live initial as well as Continuing Education at no cost to the Lebanon VAMC when applicable to ensure staff are trained and remain current in these products as well as safe receipt and handling of radioactive materials/ radiopharmaceuticals, correct use of infrastructure applications such as an online ordering portal/NMIS and any related regulatory requirement.

Ordering: Contractor will provide with their proposal contractor’s regular work hours, telephone number for call-in orders during regular business hours, contractor’s telephone number and instructions for placing emergency orders after contractor’s regular work hours to include weekends, contractor’s telephone number for expert advice concerning awarded products.

Normal orders shall be placed during the workday, and delivery shall be made to the Lebanon VA Medical Center, Nuclear Medicine Department on the date and calibrated time specified at the time of order placement. Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the Lebanon VA Medical Center. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly. in accordance with the following: The delivery order shall include the following information: contract item (s) and quantity, time (s) of delivery, and applicable VA order number.

1. Orders can be placed by the Lebanon VA Medical Center via telephone, fax, e-mail or an approved secure online ordering system. For electronic ordering systems, a closed-loop communication process such as a confirmation email is preferred.

2. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services”

3. The Lebanon VA Medical Center POCs assigned to this contract will be the only individuals authorized to place orders under this contract:

· To Be Determined

Emergency Ordering Procedures: An added cost is provided IAW with line items 1 & 2 of the schedule of items for the base for emergency preparation and delivery service of radiopharmaceuticals at other than normal working hours. Normal business hours are considered Monday through Friday: 6:30 am – 4:30 pm.

The Lebanon VA Medical Center considers the following Emergency duty hours:

· Weekdays (Monday – Friday) 4:30 pm – 6:30 am

· Weekends (Saturday/Sunday) All hours

· Federal Holidays: A list of the expected Federal Holidays is as follows: New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

Deliveries: All orders will be agreed upon between the contractor and the Department Of Veterans Affairs prior to shipment. No delivery charge shall be made for additional deliveries during normal working hours, 7:00a.m.-4:00 Monday – Friday.

Emergency Deliveries: Requests for emergency doses shall be delivered within time frame Agreed upon between the contractor and Department of Veteran Affairs. Emergency and priority orders consist of less than 20% of the monthly schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable.

After Hours Delivery: Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock Room G025 for placement of the packages in the designated pass-through.

Contractor Early Deliveries: When the Contractor offers an earlier delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contract offers no other delivery schedule, the delivery requested shall apply.

Delivery proposed:

a. Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel.

b. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.

c. Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date.

Delivery Location: Radiopharmaceuticals shall be delivered to:

· (Room G025) located within the Nuclear Medicine Department Lebanon VA Medical Center 1700 S. Lincoln Ave Lebanon, PA 17042

· Access to this room during non-business hours shall be obtained by contacting VA Police Service.

Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders 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. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following:

a. OSHA compliant monitoring devices.

b. Sealed sources for QA procedures.

c. Dose calibrator calibration.

d. Annual calibration of survey meters.

e. RSO safety audits for Federal compliance.

Damages In-transit: Under FOB Destination procedures, any in-transit damage is the responsibility of the provider. The contractor is responsible for notifying the Contracting Officer or Contracting Officer Representative within 24 hours after loss or damage of material is known by the contractor. The contractor shall be responsible for initiating action to replace all damaged or missing material to the Government.

Packaging and Shipment Preparation: All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department’s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in “ready-to-use” unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base should be present to ensure an untampered seal.

Calibration/labels: All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number.

Supplier Source Information: Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge.

Added charges: Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within three (3) hours of notification by the VA.

Estimated Quantity per year