36C25023Q0140.docx

36C25023Q0140

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

655-23-1-047-0031 36C25023Q0140 12-08-2022 Steve Bauer 937-268-6511 ext. 3935 01-12-2023 10:00

EST

36C250 Department of Veterans Affairs Dayton VA Medical Center 3140 Governors Place Blvd. Suite 210 Kettering OH 45409-1337 X 325412 1250 Employees N/A X Department of Veterans Affairs Aleda E. Lutz VAMC Nuclear Medicine 1500 Weiss Road, Room 2230a Saginaw MI 48602 36C250 Network Contracting Office (NCO) 10 Department of Veterans Affairs 3140 Governors Place Blvd. Suite 210 Kettering OH 45409-1337

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 X See CONTINUATION Page Request for Quotation for Radioactive Isotopes and Radiopharmaceutical Kit Vials (5-Year Ordering Period) Period of Performance: 01-27-2023 to 01-26-2028 Statement of Work, Table 1, must be completed, signed, and returned with quotation submittal.

Attachment entitled "Contract Line Items" Excel spreadsheet Tab entitled "Items", Columns O, AM, CE, CF, and CG shall be completed and returned as part of quotation submittal.

Quotation submittals shall be sent electronically (email) to steve.bauer@va.gov referencing the solicitation number.

See price/cost schedule starting on Page 11.

See CONTINUATION Page 655-3630160-047-822900-3131 010022900 X X X Kellie Konopinski Contracting Officer Table of Contents

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 36C250 Kellie Konopinski Contract Specialist, Steve Bauer, steve.bauer@va.gov Department of Veterans Affairs Dayton VA Medical Center 3140 Governors Place Blvd. Suite 210 Kettering OH 45409-1337

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

3. INVOICES: Invoices shall be submitted in arrears:

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:

B.2 STATEMENT OF WORK

STATEMENT OF WORK

for Radioactive Isotopes and Radiopharmaceutical Kit Vials for the Aleda E. Lutz Veterans Affairs Medical Center 22 November 2022

The contractor shall provide radiopharmaceuticals and associated supplies to Aleda E. Lutz Veterans Affairs Medical Center, Saginaw, Michigan, Monday through Friday as needed, excluding Federal holidays. Continuation of nuclear medicine services without delay in patient care or treatment at this facility requires all vendors and vendor personnel to be established, equipped, competent, and active in all items listed below. Items will include but not be limited to the following:

1. All vendor personnel preparing radiopharmaceuticals are required to be board certified in nuclear pharmacy or listed as an authorized user on the NRC radioactive materials license. Reference: Title 10 Code of Federal Regulations (10 CFR) Part 35.55 and 35.57. Or be licensed by a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals must be shipped from the Licensee directly to location of use by the Aleda E. Lutz VAMC.

2. Quantities expressed in the Price/Cost Schedule are estimates based on historical usage for one year. However, quantities may vary based on patient demand.

3. Vendor/licensee shall meet all applicable USNRC, Department of Veterans Affairs National Health Physics Program (NHPP), Department of Transportation (DOT), Food and Drug Administration (FDA), State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals.

4. In accordance with the VA Memorandum, dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans Affairs (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. The vendor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium – 235 (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium- 99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk. Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S. dependence on foreign sources of medical radioisotopes. This facility elects to purchase unit doses only. Request pricing of unit doses for all items. All Technetium 99m labeled materials require LEU generator of at least 95% non-HEU sourced molybdenum-99 materials at this facility.

5. All prices quoted on the Price/Cost Schedule for each unit item shall include any other charges including, but not limited to, delivery, fuel, emergency charges, etc. during business hours. Facility will not accept separate line items for the above.

6. This facility is established with and requires the vendor use of an on-site LEU Generator for production of all Technetium 99m labeled materials. Vendor must have active LEU generator on-site at time of solicitation to be deemed qualified.

7. Vendor shall prepare and transport kits and doses according to (including all updates to) Manufacturer’s Package Insert instructions, applicable Title 10, Code of Federal Regulations (CFR), which states: A Licensee may use for medical purposes only; By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, CFR, Part 35 and/or the equivalent regulations of an Agreement State; Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the NRC pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Requirements to include, but not limited to the instructions below:

a. Vendor shall not prepare kits using over 3 elutions from generators. All individual doses shall be traceable to the original elution if documentation requested by the facility.

b. Vendor shall perform all quality control procedures as required by Federal and when applicable, State regulatory agencies. All Vendor pharmacy quality control records shall be presented to the facility at the time of request for any dose received to include time of QC, time of elution, eluant documentation, time of preparation, and QC breakdown at any point in the material’s shelf life.

c. Vendor shall use no generic equivalent or substitute of any material without the prior written permission of the COR.

d. Vendor shall compound or prepare following all the above requirements unless prior written permission of the COR given. Radiochemical purity and radiolabel must meet manufacturer’s package insert requirements and records kept available upon request.

e. Any dose deemed below standard by the facility because: Product ordered or shipped in error, product damaged in shipment, concealed shipping damages, recalled product or outdated products in unopened original container or unacceptable thyroid, stomach, kidney, or tissue uptake shall be credited toward the account as determined by the COR.

f. The vendor shall provide radioactive material in the form requested by Aleda E. Lutz VAMC for equipment quality control testing.

g. Vendor will utilize adequate infection control standards for disinfecting the lead lined carriers of unit dose syringes (lead pigs) before and after shipments to maintain As Low As Reasonably Achievable radiation contamination practices as defined in applicable regulations.

h. Vendor will provide credit on any PPO doses not ordered or used for the following Technetium-99m-labeled radiopharmaceuticals: Tc99m-Pertechnetate, Tc99m-Sestamibi, Tc99m-HDP, Tc99m-Mebrofenin, and Tc99m Myoview. This facility must decay in storage all unit dose radioactive materials according to its radioactive materials license.

i. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations (CFR) Part 172 and 173, and Title 10, CFR Part 71.

8. The vendor shall provide Radiopharmaceuticals during standard hours of care Monday through Friday from 7 a.m. to 3:30 p.m. EST, not including Federal holidays. Radioactive sealed sources will be delivered during normal business hours Monday through Friday from 7 a.m. to 3:30 p.m. EST

9. For the placement of orders, the vendor will be contacted by the nuclear medicine staff assigned to the nuclear medicine department of the Aleda E. Lutz VAMC.

10. All routine orders for Radiopharmaceutical doses will be placed via phone, fax, or internet with vendor one day before they are needed and prior to the VA Nuclear Medicine Clinic close of business. The order shall include name of Radiopharmaceutical, specified activities of doses and calibration times. The vendor shall deliver the first run of ordered Radiopharmaceutical doses to Aleda E. Lutz VAMC, 1500 Weiss Road, Saginaw, MI 48602, Nuclear Medicine Room 2230a between 6:45-7:15 a.m. EST on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. The vendor shall deliver a subsequent run of ordered radiopharmaceuticals by 10:30 a.m. EST and if necessary, deliver a third run prior to 2:00 p.m. EST for all add-on procedures ordered.

11. Same-Day Add-on Delivery of routine non-Emergent radiopharmaceuticals can be received at Aleda E. Lutz VAMC facilities up to 120 minutes after the order is placed during normal business hours if approved by Nuclear Medicine Staff.

12. All emergency STAT orders of radiopharmaceutical doses shall be placed by Nuclear Medicine Staff Technologist on an emergency need basis. The vendor shall deliver all emergency STAT orders of Radioactive doses within 90 minutes of the dose being ordered.

13. The vendor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.

14. Vendor shall provide new package inserts and MSDS sheets for each material as they become available and upon request of the facility.

15. This facility utilizes an electronic dose tracking/management system (BioDose/EC2) for radiopharmaceuticals with EC2 software platform. Vendor may choose to either utilize compatible software that interfaces with and supports BioDose/EC2 software (including bar codes and bar code scanner operations) or utilize an alternative nuclear dose tracking system. Whether using the BioDose/EC2 or alternative tracking management system, the vendor shall price the use of the system within the unit prices of each isotope line item per the directions in Section B.3 Price/Cost Schedule of the solicitation. The contract will not include a line item for the tracking management system, but since the price for the system will be included in the individual unit prices per line item, the vendor shall provide a tracking/management system under this contract that includes all hardware, software, support, and peripherals necessary for the Aleda E. Lutz VA Medical Center's use for the duration of the contract.

16. Vendor shall provide any additional electronic technical support deemed necessary for the technical staff, physicians, patient education, etc. for the above software.

17. Vendor will provide a daily packing slip accompanying all shipments to Nuclear Medicine for all orders placed. This packing slip shall include a bar code that works with the provided electronic dose tracking/management system provided for under this contract. In addition, monthly invoices with complete itemized list of all radiopharmaceutical and other items ordered, listed by prescription number, ID used, procedure, date and time and individual cost per item (including return credits) listed.

18. The vendor shall be able to work within the provided electronic dose tracking/management system under this contract. This will allow for the receipt, inventory, disposal, and proper documentation of Radiopharmaceuticals doses dispensed.

19. The vendor shall provide courier service that is in accordance with DOT, USNRC and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed. Couriers, if it’s requested shall submit all paperwork required for access to the Aleda E. Lutz VAMC. The vendor shall be responsible for the removal of carrier containers and “empty” non-radioactive shielded carriers (lead pigs, lead vial containers, etc.) from the clinic within 72 hours of delivery.

20. All couriers will deliver product through the facility via approve route by facility VA Police. Approved route information will be provided by VA Saginaw Nuclear Medicine Department or Radiation Safety Officer.

21. The vendor shall notify the Aleda E. Lutz VAMC Nuclear Medicine Clinic immediately should the inability arise to provide Radiopharmaceutical doses. The inability to provide radiopharmaceuticals that will delay patient care gives the Aleda E. Lutz VAMC authority to purchase required radiopharmaceuticals from a different vendor.

22. The vendor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at the Aleda E. Lutz VAMC.

23. Vendor will provide quotes as needed for sheet sources, source disposals, meter calibrations, and radiopharmacy supplies.

24. Disaster and emergency preparedness: Vendor will have an alternative facility that can meet all requirements in the event of vendor’s facility incapacitation.

The following table, Table 1, is to be completed by all offerors as part of the quote/offer. Failure to complete, submit, sign, provide indicated documentation and include it with your quote/offer may deem your quote/offer unresponsive.

Table 1. Technical Requirements SOW Responses and Documentation Requirements

Items 2. and 5. and 6.

Vendor can supply all the products at the time of solicitation as listed in the Price/Cost Schedule to the Aleda E. Lutz VAMC.

Check one:

☐Vendor can meet Requirement ☐Vendor cannot meet Requirement Comments/Requested changes

Items 2. and 5. and 8. and 11.

Orders will be placed daily and as needed basis by authorized facility employees. Vendor will respond within 15 minutes of notification and deliver within 120 minutes of notification.

Check one:

☐Vendor can meet Requirement ☐Vendor cannot meet Requirement Comments/Requested changes:

Item 1.

All vendor personnel preparing radiopharmaceuticals are required to be board certified in nuclear pharmacy or listed as an authorized user on the radioactive materials license.

Submit list of all persons preparing unit doses.

Submit copies of above Pharmacist Nuclear Medicine Board Certifications for all persons preparing unit doses.

Submit copy of vendor’s facility NRC Radioactive Materials License or NRC License.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes

Item 4.

Facility elects to purchase unit doses only. Request pricing of unit doses for all items.

All Technetium 99m labeled materials require active and on-site LEU generator production of at least 95% non-HEU sourced molybdenum-99 materials at this facility.

Check one:

☐Vendor can meet Requirement ☐Vendor cannot meet Requirement Comments/Requested changes:

Items 5. and 7.h. and 17.

All prices quoted on the Price/Cost Schedule for each unit item shall include any other charges including, but not limited to, delivery, fuel, emergency charges, etc. Facility will not accept separate line items for the above.

Vendor will provide credit on any doses not ordered or unused for the following Technetium-99m-labeled radiopharmaceuticals: Tc99m-Pertechnetate, Tc99m-Sestamibi, Tc99m-HDP, Tc99m-Mebrofenin. This facility must decay in storage all unit dose radioactive materials according to its radioactive materials license.

Vendor will provide monthly invoices with complete itemized list of all radiopharmaceutical and other items ordered, listed by prescription number, ID used, procedure, date and time and individual cost per item (including return credits) listed.

Submit a sample invoice including a credited item.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement

Item 6.

Vendor is established and active with all pharmacists competent and actively preparing LEU (>95%) materials and other materials at the time of solicitation to be accepted as qualified.

Submit current manufacturer’s LEU Generator Certification for on-site generator.

Check one:

☐Vendor can meet Requirement ☐Vendor cannot meet Requirement Comments/Requested changes:

Items 7.a. and 7.b.

All doses are prepared using less than three elutions and traceable to the original elution upon facility request.

All Vendor pharmacy quality control records shall be presented to the facility at the time of request for any dose received to include time of QC, time of elution, eluant documentation, time of preparation, and QC breakdown at any point in the material’s shelf life.

Submit a sample QC report with all items above.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 7.c.

Generic equivalents or substitutes are not acceptable without prior written approval from COR.

Check one:

☐Vendor Accepts Requirement

Item 7. and 7d.

All doses are prepared in accordance with applicable requirements.

Radiochemical purity and radiolabel must meet manufacturer’s package insert requirements and records kept available upon request.

Submit sample purity and radiolabel acceptance documentation.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 7.c.

Any dose deemed below standard by the COR shall be credited for the full amount (e.g. unacceptable thyroid, stomach, kidney, or tissue uptake).

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 7.g.

Vendor will utilize adequate infection control standards for disinfecting the lead lined carriers of unit dose syringes (lead pigs) before and after shipments to maintain As Low As Reasonably Achievable radiation contamination practices as defined in applicable regulations.

Describe process to disinfect and control contamination of carriers while maintaining ALARA requirements.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 14.

Vendor shall provide new package inserts and MSDS sheets for each material as they become available.

Submit a current sample package insert and MSDS.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Items 15. and 16. and 18. and 22.

This facility utilizes an electronic dose tracking/management system (BioDose/EC2) for radiopharmaceuticals with EC2 software platform. Vendor may choose to either utilize compatible software that interfaces with and supports BioDose/EC2 software (including bar codes and bar code scanner operations) or utilize an alternative nuclear dose tracking system. Whether using the BioDose/EC2 or alternative tracking management system, the vendor shall price the use of the system within the unit prices of each isotope line item per the directions in Section B.3 Price/Cost Schedule of the solicitation.

Vendor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc.

Submit sample bar coded dose label.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 23.

Vendor will provide quotes as needed for sheet sources, source disposals, meter calibrations, and radiopharmacy supplies.

Check one:

☐Vendor Accepts Requirement ☐Vendor Rejects Requirement Comments/Requested changes:

Item 24.

Vendor will have an alternative facility that can meet all requirements in the event of vendor’s facility incapacitation.

Provide name and address of alternative facility.

Check one:

☐Vendor Accepts Requirement

I certify that the responses and information provided by me in Table 1 are accurate and complete to the best of my knowledge and belief.

Printed Name

Company Name

B.3 PRICE/COST SCHEDULE

Offerors shall complete and return the attachment entitled “Contract Line Items” to be responsive to this solicitation. The “Contract Line Items” attachment is an Excel spreadsheet which details the required supplies under this solicitation. Offerors shall only fill-in/complete the following Columns on the “Items” tab:

Column O: Unit Price

Column AM: Manufacturer Part Number

Column CE: Original Equipment Manufacturer (OEM) Country of Origin Column CF: OEM Unique Entity Identifier (UEI)/ DUNS Column CG: OEM Name

The cells in the above referenced columns requiring offeror fill-ins/completion are highlighted (yellow) in the attachment, “Contract Line Items”.

The quantities listed in Column J are estimates only based on annual consumption rates of previous years. Items will be ordered on an as needed basis following the ordering procedures of the Statement of Work.

Evaluation of Price: The estimated quantities (Column J) of each item, designated by subline item numbers (SLINs), will be multiplied by the unit price (Column O) to arrive at an extended price for each item. The summation of the extended prices of all items (over each ordering period) will establish a total price. The total price will be used exclusively for price evaluation.

The following table identifies the unit of measure to be used by offerors in determining the unit price of each item:

Note: Per Statement of Work Paragraph 15, the price of an electronic dose tracking/management system shall be rolled-up and included within the unit prices of each isotope/vial line item. Failure to quote in this manner will constitute a non-responsive quote.

B.4 DELIVERY SCHEDULE

Aleda E. Lutz Veterans Affairs Medical Center 1500 Weiss Street Saginaw, MI 48602

USA

989-497-2500 Ext. 11672 Timothy.Jackson1@va.gov

Aleda E. Lutz Veterans Affairs Medical Center 1500 Weiss Street Saginaw, MI 48602

USA

Aleda E. Lutz Veterans Affairs Medical Center 1500 Weiss Street Saginaw, MI 48602

USA

Aleda E. Lutz Veterans Affairs Medical Center 1500 Weiss Street Saginaw, MI 48602

USA

Aleda E. Lutz Veterans Affairs Medical Center 1500 Weiss Street Saginaw, MI 48602

USA

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 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 52.216-18 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 27 January 2023 through 26 January 2028.

(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.3 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 the lowest priced item on the pricing schedule, 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 the highest priced item;

(2) Any order for a combination of items in excess of the estimated annual amount; or

(3) A series of orders from the same ordering office within 3 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 1 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.4 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 26 January 2028.

(End of Clause)

C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[X] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72,…