The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 15 intends to award a sole source firm-fixed price contract under the authority of 41 U.S.C 253(c) (1) FAR 6.302-1 Only One Responsible Source to Progenics Pharmaceuticals, Inc., 331 Treble Cove Rd, N. Billerica, MA 01862 on behalf of the Kansas City VA Medical Center, 4801 Linwood Boulevard, Kansas City, MO 64128 for PYLARIFY (piflufolastat F 18) Injection. The Government intends to award a firm-fixed price Basic Ordering Agreement (BOA) for a total of five (5) one-year ordering periods. The NAICS code is 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1,300 Employees. The corresponding Product Service Code is 6505 (Drugs and Biologicals). Interested firms may express their interest by providing a capabilities statement no later than April 8, 2024 at 8AM Central Standard Time. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required supply and/or services in accordance with the statement of requirement. Those interested firms must indicate whether they are large, small, small-disadvantaged, 8(a) or woman owned business and whether they are U.S. or foreign owned. Respondents who submit proprietary data shall clearly mark the data with appropriate markings. The Government will not pay for any information submitted as a result of this notice. This notice shall not be construed as an obligation on the part of the Government to acquire any supplies and/or services. Verbal responses are not acceptable and will not be considered. This notice of intent to award a sole source contract is being issued for information purposes only and does not constitute a solicitation or request for competitive proposals. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. There will be no solicitation available for competitive proposals as market research has determined these services are only available from a single source without an unacceptable delay or duplication of cost and no other type of services will satisfy agency requirements. If a firm believes it is capable of meeting the Governments requirement, it may identify their interest and capability to the Contracting Officer. The point of contact for this action is Contracting Officer Mickeya Linzie, who can be reached at mickeya.linzie@va.gov. Phone calls will not be accepted. The Network Contracting Office 15 address is: VA Heartland Network 15, Network Business Office, Contracting Office, 3450 South. 4th Street, Leavenworth, KS 66048. STATEMENT OF REQUIREMENT Description/Specifications Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Kansas City VA Medical Center, Kansas City, MO located at 4801 E. Linwood Blvd, Kansas City, MO 64128 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Kansas City, MO need to respond to this RFQ. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, UNNRC, and ICC regulations and standards. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at Kansas City VA Medical Center (KCVA) upon commencement of this contract. Supplier shall immediately notify KCVA, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts. FDG-18 PSMA product radiopharmaceuticals not used will be returned for credit the next work day, using the DOT regulations. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center: Contractor s regular work hours Contractor s telephone number for call-in orders during regular work hours. Contractor s telephone number and instructions for placing Emergency orders after contractor s regular work hours, including weekends. Contractor s telephone number for expert advice concerning awarded products. Contractor will furnish a statement that any radiopharmaceuticals delivered as ready-to-use (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of The Joint Commission (TJC) and/or with the United States Pharmacopeia. Should any changes occur in above information during contract performance period, contractor will provide updates in writing. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Kansas City VA Medical Center. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%. The expiration date and time shall be indicated and affixed to each product as noted below; in general: Ready-to-use doses: not shorter than two (2) hours. FDG-18: Not shorter than two (2) hours. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise in calibration; Provide professional examination of product; submit results and recommendations to the Contacting Officer; Make expedient replacement of any product suspected of being deficient. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. Deliverables and Acceptance Criteria Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below: Provide up to four deliveries per day during regular operating hours to KCVA. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 10:00 am, as requested from the previous day. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hour of notification. Deliveries occurring outside of working hours are directed to KCVA Police. Contractor will not have access Nuclear Medicine outside of working hours. Other delivery times may be outlined by the KCVA under this contract. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular work day. Holidays are listed herein. Shipments called when needed may be requested during regular work hours, or after, as emergency , including weekends, holidays and nights. Shipments requested as an Emergency will be delivered as follows: Requests placed after regular work hours (weekend, holiday, and night) will be delivered within three (3) hours, or as specified. Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations. All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by KCVA under this contract, will be strictly adhered to. All shipments will have a Packing Slip enclosed, giving information about the product and it s identification, plus (for billing purposes) the VA Medical Center s Purchase Order Number issued for the current fiscal quarter or month, and the Contractor s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.) Work Hours The delivery of products provided by this contract shall be furnished by the contractor. The contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30a.m. to 4:30 p.m. Normal Next Day Delivery: 7:15a.m. National Holidays: The ten holidays observed by the Federal Government are: New Years Day, Martin Luther Kings Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract. Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and TJC guidelines. Contractor Performance Assessments Assessments. The Government may do assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to assessments. Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts

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