S02 Radiopharmaceuticals Mpls VAMC 36C26326Q0003.docx

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Minneapolis VAMC Radiopharmaceuticals Solicitation Notice
Solicitation number
36C26326Q0003
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This document is a Standard Form 1449 Solicitation/Contract/Order for Commercial Products and Commercial Services issued by the Department of Veterans Affairs for radiopharmaceuticals for the Minneapolis Veterans Affairs Health Care System. The solicitation seeks radiopharmaceutical agents including Axumin, Amyvid, Tauvid, Cerianna, Posluma, and Pluvicto, with quantities estimated based on historical usage and to be delivered on an "on-demand, as-needed" basis. The contract will have a base pricing period from 10/01/2025 to 09/30/2026 with four additional one-year option periods through 10/01/2030, with a minimum order of $1,000 and a maximum order limit of $1,500,000 per single item or $2,000,000 for combination items.

Key solicitation details include an offer due date of 09/08/2025 at 12:00 CDT, a contract minimum guarantee of $2,000 and a maximum spend ceiling of $6,000,000, and a Lowest Price Technically Acceptable (LPTA) evaluation methodology. The contractor must be licensed by the State of Minnesota and the Nuclear Regulatory Commission, comply with all NRC and DOT packaging requirements, provide quality control documentation, and deliver radiopharmaceuticals directly to the nuclear medicine department. Delivery will be made to specified VA Medical Center locations in Minneapolis, with invoicing conducted monthly through electronic submission methods.

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S02 Vendor Pricing Schedule.xlsx XLSX spreadsheet

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PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

618-26-1-4005-0002

36C26326Q0003 08-26-2025 Jeffrey Brown 651-293-3009 09-08-2025 12:00

CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X

Y 325412 1300 Employees

N/A

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page This solicitation is for radiopharmaceuticals for the Veterans Administration Minneapolis Health Care System in accordance with the Statement of Work and Schedule.

Prior to submitting a quote, review all documentation within.

Review and follow the instructions in the INSTRUCTIONS TO OFFERORS in the Clause 52.212-1 Addendum.

Contract Ordering Period with pricing periods of:

Base Pricing Period: 10/01/2025-09/30/2026 Year One Pricing Period: 10/01/2026-09/30/2027 Year Two Pricing Period: 10/01/2027-09/30/2028 Year Three Pricing Period: 10/01/2028-09/30/2029 Year Four Pricing Period: 10/01/2029-09/30/2030

See CONTINUATION Page

Jeffrey Brown

VA-VHA-RPOC-2024-0033

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 PRICE/COST SCHEDULE5
ITEM INFORMATION5
B.3 RADIOPHARMACEUTICAL STATEMENT OF WORK11
SECTION C - CONTRACT CLAUSES16
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)16
C.2 52.216-2 ECONOMIC PRICE ADJUSTMENT—STANDARD SUPPLIES (NOV 2021)22
C.3 52.216-18 ORDERING (AUG 2020)23
C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)23
C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)24
C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)24
C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)25
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)26
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)26
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS35
See attached document: S02 Vendor Pricing Schedule.35
SECTION E - SOLICITATION PROVISIONS35
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)35
ADDENDUM to 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services.39
E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)41
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)41
E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)44
E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)45
E.6 52.216-1 TYPE OF CONTRACT (APR 1984)46
E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)46
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)47
E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)47
52.212-2 Evaluation—Commercial Products and Commercial Services. (November 2021)48
E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025)49

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263 Jeffrey Brown

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[X]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

B.2 PRICE/COST SCHEDULE

This Indefinite Quantity contract minimum guarantee is $2,000.00; the maximum spend (ceiling price) shall not exceed $6,000,000.00

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
3.00
EA
__________________
__________________

Axumin (fluciclovine F 18) 10 mCi Contract Period: Base POP Begin: 10-01-2025 POP End: 10-01-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

2.00
EA
__________________
__________________

Amyvid (florbetapir F 18) 10 mCi

POP Begin: 10-01-2025 POP End: 10-01-2026

1.00
EA
__________________
__________________

Tauvid (flortaucipir F18) 10 mCi

POP Begin: 10-01-2025 POP End: 10-01-2026

2.00
EA
__________________
__________________

Cerianna (fluoroestradiol F18) 6 mCi

POP Begin: 10-01-2025 POP End: 10-01-2026

150.00
EA
__________________
__________________

Posluma (flotufolastat F 18) 8 mCi

POP Begin: 10-01-2025 POP End: 10-01-2026

160.00
EA
__________________
__________________

Delivery charges per shipment

POP Begin: 10-01-2025 POP End: 10-01-2026

3.00
EA
__________________
__________________

Axumin (fluciclovine F 18) 10 mCi Contract Period: Option 1 POP Begin: 10-01-2026 POP End: 10-01-2027

2.00
EA
__________________
__________________

Amyvid (florbetapir F 18) 10 mCi

POP Begin: 10-01-2026 POP End: 10-01-2027

1.00
EA
__________________
__________________

Tauvid (flortaucipir F18) 10 mCi

POP Begin: 10-01-2026 POP End: 10-01-2027

2.00
EA
__________________
__________________

Cerianna (fluoroestradiol F18) 6 mCi

POP Begin: 10-01-2026 POP End: 10-01-2027

150.00
EA
__________________
__________________

Posluma (flotufolastat F 18) 8 mCi

POP Begin: 10-01-2026 POP End: 10-01-2027

160.00
EA
__________________
__________________

Delivery charges per shipment

POP Begin: 10-01-2026 POP End: 10-01-2027

3.00
EA
__________________
__________________

Axumin (fluciclovine F 18) 10 mCi Contract Period: Option 2 POP Begin: 10-01-2027 POP End: 09-30-2028

2.00
EA
__________________
__________________

Amyvid (florbetapir F 18) 10 mCi

POP Begin: 10-01-2027 POP End: 09-30-2028

1.00
EA
__________________
__________________

Tauvid (flortaucipir F18) 10 mCi

POP Begin: 10-01-2027 POP End: 09-30-2028

2.00
EA
__________________
__________________

Cerianna (fluoroestradiol F18) 6 mCi

POP Begin: 10-01-2027 POP End: 09-30-2028

150.00
EA
__________________
__________________

Posluma (flotufolastat F 18) 8 mCi

POP Begin: 10-01-2027 POP End: 09-30-2028

160.00
EA
__________________
__________________

Delivery charges per shipment

POP Begin: 10-01-2027 POP End: 09-30-2028

3.00
EA
__________________
__________________

Axumin (fluciclovine F 18) 10 mCi Contract Period: Option 3 POP Begin: 10-01-2028 POP End: 10-01-2029

2.00
EA
__________________
__________________

Amyvid (florbetapir F 18) 10 mCi

POP Begin: 10-01-2028 POP End: 10-01-2029

1.00
EA
__________________
__________________

Tauvid (flortaucipir F18) 10 mCi

POP Begin: 10-01-2028 POP End: 10-01-2029

2.00
EA
__________________
__________________

Cerianna (fluoroestradiol F18) 6 mCi

POP Begin: 10-01-2028 POP End: 10-01-2029

150.00
EA
__________________
__________________

Posluma (flotufolastat F 18) 8 mCi

POP Begin: 10-01-2028 POP End: 10-01-2029

24.00
EA
__________________
__________________

Pluvicto(lutetium Lu 177 vipivotide tetraxetan) 200mCi

POP Begin: 10-01-2028 POP End: 10-01-2029

184.00
EA
__________________
__________________

Delivery charges per shipment

POP Begin: 10-01-2028 POP End: 10-01-2029

3.00
EA
__________________
__________________

Axumin (fluciclovine F 18) 10 mCi Contract Period: Option 4 POP Begin: 10-01-2029 POP End: 10-01-2030

2.00
EA
__________________
__________________

Amyvid (florbetapir F 18) 10 mCi

POP Begin: 10-01-2029 POP End: 10-01-2030

1.00
EA
__________________
__________________

Tauvid (flortaucipir F18) 10 mCi

POP Begin: 10-01-2029 POP End: 10-01-2030

2.00
EA
__________________
__________________

Cerianna (fluoroestradiol F18) 6 mCi

POP Begin: 10-01-2029 POP End: 10-01-2030

150.00
EA
__________________
__________________

Posluma (flotufolastat F 18) 8 mCi

POP Begin: 10-01-2029 POP End: 10-01-2030

24.00
EA
__________________
__________________

Pluvicto(lutetium Lu 177 vipivotide tetraxetan) 200mCi

POP Begin: 10-01-2029 POP End: 10-01-2030

184.00
EA
__________________
__________________

Delivery charges per shipment

POP Begin: 10-01-2029 POP End: 10-01-2030

GRAND TOTAL
__________________

36C26325Q1109

Page 1 of Page 1 of

B.3 RADIOPHARMACEUTICAL STATEMENT OF WORK

1. GENERAL:

1.1. The purpose of this contract is to provide Minneapolis Veteran Affairs Health Care System with Brand name or equal radiopharmaceutical agents and provide the delivery of those agents to the Nuclear Medicine Department, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Minneapolis, MN 55472, here in referred to as MVACHS.

2. Estimated Quantities:

2.1. The quantities as listed in the “Schedule of Items” are estimated requirements based on historical usage. The MVAHCS attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed. MVAHCS does not guarantee to order the quantities listed. The unit prices supplied quoted to NCO 23 contracting officer shall apply to the quantities actually ordered by Authorized Ordering Individuals.

2.2. All products will be requested on an “on demand, as needed” basis order via phone or email by MVACHS authorized personnel only. Authorized ordering Individuals are MVAHCS Nuclear Medicine Technologists and the COR (Contracting Officer Representative).

2.3. Schedule of Radiopharmaceuticals

CLIN
Product #
Description

Axumin (fluciclovine F 18)

Amyvid (florbetapir F 18)

Tauvid (flortaucipir F18)

Cerianna (fluoroestradiol F18)

Posluma (flotufolastat F 18)

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

2.4. Brand Name or Equal Schedule Salient Characteristics

2.4.1. Any items offered must be functionally equivalent to the generic and/or brand name radiopharmaceuticals listed below as these have been validated for use in the MVACHS Nuclear Medicine Department. Any equivalency must be substantiated with published studies/testing.

2.4.1.1. Axumin: Must be able to be used to detect recurrent disease with Prostate Specific Antigen (PSA) levels less than 10.

2.4.1.2. Amyvid: Must be able to be used in the Positive Emission Tomography (PET) imaging of the brain to estimate plaque density in adult patients with Alzheimers disease and other causes of cognitive decline.

2.4.1.3. Tauvid: Must be approved to image tau neurofibrillary tantles (NFTs) which are significant in assessing the severity of AD and its progression.

2.4.1.4. Cerianna: Must be able to be used in Estrogen Receptor (ER+) targeted molecular imaging of lesions in patients with recurrent or metastatic breast cancer.

2.4.1.5. Posluma: Must be able to be used in PET imaging in men with prostate cancer to detect positive lesions and metastasis prior to initial therapy.

2.4.1.6. Pluvicto (lutetium-177 vipivotide tetraxetan): Must target the prostate specific membrane antigen on prostate cells to deliver the radiotracer lutetium-177, providing targeted radioligand therapy.

3. Deliveries:

3.1. Deliveries shall be made to one of MVAHCS hot rooms, to be specified at time of ordering by MVACHS between 8:00 am and 3:00 pm Monday-Friday except on Federal Holiday:

Location 1:

VA Medical Center, Bldg 70, Room BW101D Warehouse (90D), PO#________ One Veterans Drive Minneapolis, MN 55417

Location 2:

VA Medical Center, Bldg 70, Room BV113 Warehouse (90D), PO#________ One Veterans Drive Minneapolis, MN 55417

3.2. The Federal Holidays (actual days observed by the Federal Government) are:

New Year’s Day Martin Luther King’s Birthday Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day And any day specifically declared by the President of the United States to be a national holiday.

Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

3.3. All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain Vendor’s name, Purchase order number, Date of order, Date of delivery, Itemized list of products furnished including product description, and quantity shipped.

3.4. All products are purchased subject to acceptance by the MVAHCS, Nuclear Medicine Service. 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 outdate. The MVACHS shall not be financially liable for unacceptable radiopharmaceutical agents.

3.5. At no time shall delivery drive leave radioactive material unattended in facility. All delivery’s shall be delivered directly to the nuclear medicine department in one of their “hot rooms”.

4. REQUIREMENTS:

4.1. Contractor must be licensed by the State of Minnesota. Additionally, Contractor must the licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of these licenses and certifications upon request of the Contracting Officer.

4.2. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission. All products provided under this contract shall be packaged and shipped in accordance with the requirements of the Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and the DOT.

4.3. All products provided under this contract shall be in compliance with all OSHA manufacturing, packaging and shipping regulations.

4.4. All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available.

4.5. The Contractor shall guarantee the quality of all radiopharmaceuticals. The Contractor shall provide quality control on each agent dispensed.

4.6. The Contractor shall provide complete documentation on quality Control results upon request.

4.7. The Contractor shall provide documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and Minneapolis VAHCS Radioactive Material License (RAM).

4.8. The Contractor shall be capable of providing the radiopharmaceuticals and estimated quantities necessary to provide operation levels.

4.9. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only:

4.9.1. Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State:

4.9.2. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

4.10. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

4.11. The Contractor must provide a copy of their laboratory’s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture.

4.12. The Contractor must test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The Contractor will provide a detailed description of the test upon request.

4.13. The Contractor must assign to this medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy.

4.14. The Contractor must provide current material safety data sheets in a in a binder and updates as necessary on all delivered products for each medical center or the Contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

4.15. The Contractor may provide patient orientation education video presentations and other appropriate material as deemed necessary by the medical center.

4.16. The Contractor may provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in handling of radioactive materials.

4.17. The Contractor must replace any items delivered in error at no cost to the government.

4.18. The Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc.

4.19. Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request.

4.20. No Employee status: The Contractor shall be responsible for protecting the Contractor’s staff furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following are provided for all their staff providing services under the resultant contract:

4.20.1. Workers’ compensation

4.20.2. Professional liability insurance

4.20.3. Health examinations

4.20.4. Income tax withholding, and

4.20.5. FICA and Medicare tax withholding

5. TRANSPORTATION

5.1. The Contractor personnel, drivers and alternates, shall be able to read, write, speak and understand English language. Personnel shall present a neat appearance and be easily recognized as a contract employee by wearing an identification badge that includes the company’s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company’s name/logo.

5.2. Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers’ licenses, vehicle insurance and registration.

5.3. The Contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number and description of items for each location, along with signatures.

5.4. The Contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss.

5.5. All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the Contractor.

6. BILLING/INVOICES:

6.1. Contractor must submit a monthly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum:

Purchase Order Number
Name of Radiopharmaceutical agent and the number provided
The unit/unit cost
Total price

6.2. Contractor shall 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 must be received within 48 hours of notification by the VA.

6.3. Contractor shall provide upon request a detailed description of the test to be performed, as provided by the manufacturer.

6.4. Billings rendered by the Contractor to the Minneapolis VA Health Care System for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed.

6.5. Payments for services will be at the rates specified in the Schedule of Supplies/Services.

6.6. Payment shall only be made for actual services rendered and items that are received and found acceptable.

6.7. Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The Contractor shall submit electronic payment requests through:

6.8. VA’s Electronic Invoice Presentment and Payment System (See Web site at http://www.fsc.va.gov/einvoice.asp.); or,

6.9. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

6.10. The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program:

Tungsten e-Invoice Setup Information: 1-877-489-6135
Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
FSC e-Invoice Contact Information: 1-877-353-9791
FSC e-invoice email: vafsccshd@va.gov

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-2 ECONOMIC PRICE ADJUSTMENT—STANDARD SUPPLIES (NOV 2021)

(a) The Contractor warrants that the unit prices stated in the Schedule for line items 0001-4007 are not in excess of the Contractor's applicable established prices in effect on the contract date for like quantities of the same item. The term "unit price" excludes any part of the price directly resulting from requirements for preservation, packaging, or packing beyond standard commercial practice. The term "established price" means a price that—

(1) Is an established catalog or market price for a commercial product sold in substantial quantities to the general public; and

(2) Is the net price after applying any standard trade discounts offered by the Contractor.

(b) The Contractor shall promptly notify the Contracting Officer of the amount and effective date of each decrease in any applicable established price. Each corresponding contract unit price shall be decreased by the same percentage that the established price is decreased. The decrease shall apply to those items delivered on and after the effective date of the decrease in the Contractor's established price, and this contract shall be modified accordingly.

(c) If the Contractor's applicable established price is increased after the contract date, the corresponding contract unit price shall be increased, upon the Contractor's written request to the Contracting Officer, by the same percentage that the established price is increased, and the contract shall be modified accordingly, subject to the following limitations:

(1) The aggregate of the increases in any contract unit price under this clause shall not exceed 10 percent of the original contract unit price.

(2) The increased contract unit price shall be effective—

(i) On the effective date of the increase in the applicable established price if the Contracting Officer receives the Contractor's written request within 10 days thereafter; or

(ii) If the written request is received later, on the date the Contracting Officer receives the request.

(3) The increased contract unit price shall not apply to quantities scheduled under the contract for delivery before the effective date of the increased contract unit price, unless failure to deliver before that date results from causes beyond the control and without the fault or negligence of the Contractor, within the meaning of the Default clause.

(4) No modification increasing a contract unit price shall be executed under this paragraph (c) until the Contracting Officer verifies the increase in the applicable established price.

(5) Within 30 days after receipt of the Contractor's written request, the Contracting Officer may cancel, without liability to either party, any undelivered portion of the contract items affected by the requested increase.

(d) During the time allowed for the cancellation provided for in paragraph (c)(5) of this clause, and thereafter if there is no cancellation, the Contractor shall continue deliveries according to the contract delivery schedule, and the Government shall pay for such deliveries at the contract unit price, increased to the extent provided by paragraph (c) of this clause.

(End of Clause)

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 10/01/2025 through 09/30/2030.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1,500,000.00;

(2) Any order for a combination of items in excess of $2,000,000.00; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 30 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after contract expiration.

(End of Clause)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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