36W79725R0001.pdf

PAGE 1 OF 73 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. DUNS: DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36W79725R0001 05-01-2025

Bonita Smith (Bonita.Smith@va.gov) 708-786-5175 06-02-2025

2:30pm CT

Department of Veterans Affairs

OA&L / NAC (003A4C4)

1st Avenue, One Block North of Cermak Rd

Bldg. 37

Hines, IL 60141

X

311999

500 Employees

N/A N/A

Direct to Government Facilities, Subsistence Prime Vendor, Pharmaceutical Prime Vendor and

Direct to Patient Program Vendor

Refer to Attachment "F"

Department of Veterans Affairs

OA&L / NAC (003A4C4)

1st Avenue, One Block North of Cermak Rd

Bldg. 37

Hines IL 60141

Government Facilities, Subsistence Prime Vendor, Pharmaceutical Prime Vendor, Direct-to-Patient Program Vendor

Refer to Attachment "F"

FSC 89 -- Dietary Supplements, Tube Feeding Products, Thickeners and Pre-Thickened Beverages.

(Refer to Attachment E - Schedule of Supplies for product details)

X 1 copy

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SCOPE OF CONTRACT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS

C.2 52.216-21 REQUIREMENTS (OCT 1995)

ADDENDUM to FAR 52.216-21 REQUIREMENTS

C.3 VAAR 852.246-72 FROZEN PROCESSED FOODS (OCT 2018)

C.4 52.247-34 F.O.B. DESTINATION (NOV 1991)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.6 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

C.7 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS

(DEVIATION) (JAN 2023)

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

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (SEP 2023)

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

E.3 52.203-2 CERTIFICATE OF INDEPENDENT PRICE DETERMINATION (APR 1985)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES-REPRESENTATION

(OCT 2020)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.7 52.219-1 SMALL BUSINESS PROGRAM REPRESENTAITONS (FEB 2024)

E.8 52.223-22 PUBLIC DISCLOSURE OF GREENHOUSE GAS EMISSIONS AND REDUCTION GOALS-

REPRESENTATION (DEC 2016)

E.9 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.10 52.216-1 TYPE OF CONTRACT (APR 1984)

E.11 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.12 52.204-7 SYSTEM FOR AWARD MANAGEMENT (NOV 2024)

E.13 52.212-2 EVALUATION – COMMERCIAL ITEMS (NOV 2021)

E.14 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS. (MAY

2024)

E.1552.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

Continuation of SF-1449, Block 3:

The following information shall be entered by the Contracting Officer at the time of contract award according to the timeframes specified in this solicitation’s Section B, Scope of Contract, Section 1.4

Contract Effective Date, Implementation Period, and Ordering Period.

Contract Award/Effective Date: ___________________

Implementation Period: __________________________

Ordering Period (Base Year): _____________________

Offerors shall not enter information into the above fields.

CONTACT FOR CONTRACT ADMINISTRATION

Offerors are requested to designate a person to be contacted for prompt contract administration.

NAME & TITLE___________________________________

ADDRESS ________________________________________

CITY, STATE, ZIP CODE _________________________

E-MAIL ADDRESS ________________________________

PHONE NO. _______________________________________

SALES REPORTS POC

NAME & TITLE _______________________________________

E-MAIL ADDRESS _________________________________________

PHONE NO. _________________________________________

AUTHORIZED NEGOTIATORS

The offeror or quoter represents that the following persons are authorized to negotiate on its behalf with the Government in connection with this request for proposals or quotations: (list names, titles, e-mail addresses, and telephone numbers of the authorized negotiators)

NAME & TITLE ______________________ NAME & TITLE _________________________

E-MAIL ADDRESS __________________ E-MAIL ADDRESS ________________________

PHONE NO. ________________________ PHONE NO. _____________________________

SCOPE OF CONTRACT

1.0 INTRODUCTION

1.1 Acronyms. The following acronyms apply to this solicitation.

• VA – Department of Veterans Affairs

• IHS – Indian Health Service

• BOP – Bureau of Prison

• DoD – Department of Defense

• FHCC – Federal Healthcare Center

• SVH – State Veteran Home

• OGA – Other Government Agencies (non-VA)

• PPV – Pharmaceutical Prime Vendor

• SPV – Subsistence Prime Vendor

• PVP – Prime Vendor Program

• DTP – Direct-to-Patient Program

• CMOP – Consolidated Mail Outpatient Pharmacy

• RTH – Ready-to-Hang (Closed System)

• RTS – Ready-to-Serve (Individual packages for patient use)

• RTU – Ready-to-Use

1.2 Background. The Department of Veterans Affairs (VA) and Other Government Agencies

(OGAs) included in this procurement have a continued requirement for commercially prepared dietary supplements and tube feeding products. These products are required to enhance a patient’s nutritional status prior to, during, and following extended medical procedures or nutritionally stressing medical conditions. The VA and OGAs acquire dietary supplement requirements either by ordering direct with the contractor or by placing orders through the

Subsistence Prime Vendor (SPV) Program, the Pharmaceutical Prime Vendor (PPV) program, or through Direct-to-Patient (DTP) Distribution Program (Refer to Attachment F). This solicitation utilizes generic product specifications with ranges of acceptable nutrient levels in order to establish significant competition from multiple contractors. One or more contracts will result from this solicitation, which will establish the VA National Contract prices for the products listed in the schedule of supplies that will be distributed through each respective SPV, PPV, and DTP program. Section 3.1 “Government Participants” lists the participants that will be authorized users of the contract resulting from this solicitation.

1.3 Subsistence Prime Vendor. The SPV program is a wholly separate and independent contract from this solicitation. Under the SPV program, VA awards a separate contract for product and product distribution. SPV is a mandatory contract for all VAMCS and is optional to OGAs. All

SPV customers are eligible for products and prices awarded through this contract. See

“Attachment F” for eligible OGAs.

U.S. Foods is the current SPV, which was awarded on November 1, 2024. The first option period was exercised on November 1, 2024, and the options to extend the contract may not exceed

October 31, 2028.

1.4 Pharmaceutical Prime Vendor. The PPV program is a wholly separate and independent contract from this solicitation. Under this program, VA awards a separate contract for product distribution and separate contracts for the source and purchase price of the product(s).

1.5 Direct-to-Patient (DTP) Program. The DTP program is a wholly separate and independent contract from this solicitation. The DTP Program is a concept of support whereby a commercial vendor serves as a contractor of VA’s Consolidated Mail Outpatient Pharmacies (CMOP) to deliver products directly to VA patient’s homes. Under the DTP program, the Direct-to-Patient

Distribution contractor places orders with contractors, maintains an inventory of products, and ships product received from the contracts to VA patients at the direction of VA’s CMOP facilities. The Direct-to-Patient contractor directly pays the Dietary Supplement contractors for products ordered and delivered to the DTP’s facilities.

1.6 Purpose and Objectives. The purpose of this solicitation is to establish a volume-based committed-use National Contract(s) with contractor(s) which will provide a consistent and reliable supply source for the products provided in this solicitation to all eligible customers on a direct basis or through an authorized VA SPV, PPV and DTP.

1.7 Contract Duration. The contract resulting hereunder will be in effect for the duration of the

Implementation Period described in Section 1.9 plus one (1) year Ordering Period with four (4) one (1) year pre-priced option (ordering) periods that may be exercised unilaterally by the

Government in accordance with FAR 17.207 and FAR 52.217-9.

1.8 Government Purchase Compliance. VA, FHCC, IHS, SVH (Option 2), DoD, IHS, and BOP will purchase their requirements through the SPV or PPV Programs.

1.9 Award. Award will be based on a technically acceptable, lowest price source selection process as described in Part IV of the solicitation.

(A) Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF-1449 and notifies the offeror (contractor) of award.

(B) Implementation Period. Contractors will be allowed a maximum of a 90-calendar day

Implementation period, but this period may be shorter if mutually agreed between the contractor and the Government.

1.10 Authorized Users. See Attachment F.

2.0 DELIVERY

2.1 Direct Delivery. When an ordering activity as identified in Attachment F selects this method of distribution, the contractor shall deliver all requirements to the facility within the timeframe stipulated in the contract.

• Delivery shall be F.O.B. Destination.

• Minimum Order is $50.00.

• Product expiration dating remaining at time of delivery to the Government shall be at least six months.

• Delivery shall be within 3-5 days After Receipt of Order (ARO).

• Acceptance of the Government-wide commercial purchase card up to the micro-purchase threshold.

2.2 PPV (SPV & PPV). The contractor(s) shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements with the SPV and

PPV have been executed with sufficient time to permit the SPV and PPV to begin timely distribution of Government orders by the expiration of the contract implementation period. The current SPV and PPV are listed as attachment “F” of this solicitation. The current SPV and PPV may change, and the contractor will be notified of any changes in SPV and PPV contractors during the term of the contract resulting from this solicitation. Payment terms, time, and place of delivery to SPV and PPV distributors and other business-to-business agreement terms shall be agreed upon between the SPV and PPV contractors and the contractor awarded a contract from this solicitation. While it is a requirement that the contractor establish a business-to-business agreement with the SPV and PPV, the Government is not a party to this business-to-business agreement and does not negotiate for either the Contractor or SPV and PPV. The Contracting

Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the SPV and PPV by 15 calendar days before commencement of the Ordering

Period. Failure or refusal to reach agreement with the SPV and PPV and maintain an agreement with the SPV and PPV throughout the entire contract period shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions-Commercial

Products and Commercial Services, Termination for Cause.

2.3 Direct-to-Patient Distribution (DTP) Program. Contractor(s) shall ensure that sufficient inventory is available and agreements with the DTP contractor are in place sufficiently in advance of November 1, 2025, to permit the DTP contractor to dispatch shipments from their distribution facilities to ordering activities. Requirements for time, quantity, place, and method of delivery of items sold through the DTP program will be determined between the awarded contractor and the authorized Government DTP contractor.

3.0 EXTENT OF OBLIGATION

3.1 Government Participants. The contractor shall provide the nutritional dietary products as specified in the Schedule of Supplies, Attachment E, at the prices awarded herein for the facilities listed in Attachment F.

PPV Customer List – A database of all facilities authorized to use the PPV Program may be downloaded from the National Acquisition Center’s web site at http://www.va.gov/oal/business/nc/ppv.asp . The database identifies the agency classification for each participant. Additionally, the regional area for each IHS facility is identified, and each State

Veteran Home is identified as option 1 or 2 (See paragraph 3.3 State Veterans Homes)

A list of all facilities authorized to use the SPV Program will be provided with award.

3.2 Federal Healthcare Center (FHCC). The Federal Healthcare Center is a fully integrated VA and DoD entity. Currently, there is only one facility of this type, located in Illinois.

http://www.va.gov/oal/business/nc/ppv.asp

3.3 State Veteran Homes (SVH’s). There are numerous State Veteran Homes (SVHs) that have entered into sharing agreements with VA Medical Centers (VAMCs). The SVHs with sharing agreements that participate in the VA PPV Program are identified as being one of two types:

Option 1 or Option 2.

Option 1: The SVH orders pharmaceuticals directly from the VA PPV and pays the VA PPV for all items purchased. An Option 1 SVH is not eligible for national contract prices awarded under this solicitation unless it is specifically named in the scope of contract or added after award by mutual agreement.

Option 2: The VAMC authorizes the SVH’s order, and the VAMC makes payment to the VA PPV for all pharmaceuticals ordered by the SVH. An Option 2 SVH is eligible for the national contract prices awarded under this solicitation.

4.0 ESTIMATED QUANTITIES

The quantities shown in the Schedule of Supplies reflect the estimated annual usage for VA and all

OGAs participating under this contract. It is estimated that 45% of the products will be distributed through the Subsistence Prime Vendor Programs, and 55% will be ordered by and delivered directly to Government facilities or by the CMOP via the PPV and DTP Program. Frozen products will only be made available through the Subsistence Prime Vendor.

5.0 PRODUCT CATEGORIES

This solicitation includes four Product Categories with multiple product groups and specific line items. The categories (titled with Roman Numerals) are broad descriptions of products. The product groups (titled with Roman Numerals followed by a number) are generic product descriptions with specific requirements. The line items (titled with Roman Numerals followed by a number and alpha character) define specific packing and/or flavor characteristics.

EXAMPLE:

I. THERAPEUTIC ORAL NUTRITIONAL PRODUCTS (Product Category)

I-1 Basic (1 - 1.1 cal) Nutritional Drink; Liquid, Ready-to-Serve, Flavored, Good Taste (Product

Group)

(Package Size: 237 - 250 ml container, Brick Pack or Plastic Bottle with Resealable Cap)

I-1a* Vanilla: 237 - 250 ml container

(Product Line Items)

I-1b* Chocolate: 237 - 250 ml container

I-1c Other Flavor: 237 - 250 ml container

PRODUCT CATEGORY I Therapeutic Oral Nutritional Products

PRODUCT GROUP I-1 Basic (1 - 1.1 cal) Nutritional Drink; Liquid, Ready-to-Serve, Flavored, Good Taste

LINE ITEM I-1a Nutritional Drink, Vanilla: 237 - 250 ml container

Product Group I-1 will require offeror(s) to propose pricing for the required lines items, indicated by the *, where lines items I-1a and I-1b above are required to complete Product Group

I-1. Line item I-1c is optional based on availability of other flavors. The inclusion of optional line items will not increase or decrease the likelihood of being the lowest priced – technically acceptable offeror. If an optional item is proposed and awarded, it is a contractual requirement.

6.0 PRICING

VA intends to evaluate price for each product group for categories I, II, III, and IV shown in the

Schedule of Supplies, Attachment E, on a separate basis. There will be only one award per product group for all mandatory and proposed optional line items; and multiple awards per product category are possible. Offeror shall propose a price, not to exceed two decimal places, for every required line item within a product group for all categories and for every required line item for the base year and all option periods. Prices offered shall be submitted inclusive of F.O.B. Destination for Direct

Delivery (orders submitted by and shipped directly to Government ordering facilities), as well as orders placed and distributed through the SPV, PPV or DTP programs. Offered prices shall include a 0.50% Cost Recovery Fee (CRF), please refer to paragraph 11. Offeror shall submit proposals under the “Pricing Proposal” tab in Attachment E.

7.0 SAMPLES

Contractors shall submit shelf stable product samples as reflected in Attachments A, B, C, and D on or before the solicitation due date. See FAR Clause 52.212-1, Instructions to Offerors, within this solicitation for additional information on submission of samples.

8.0 ADDITIONAL REQUIREMENTS

8.1 Offerors must provide a unique NDC Number and/or UPC number for each item offered. Non-manufacturers please refer to Addendum 52.212-1- Instructions to Offerors, in section E of this solicitation.

8.2 All Closed System (RTH) tube feeding products that requires a compatible spike sets or should be available for purchase on a Federal Supply Schedule Service contract.

8.3 Powdered products cannot be substituted for liquid specific products and refrigerated/frozen products cannot be substituted for shelf stable specific products, unless noted in the product description.

8.4 The Government reserves the right to modify the generic nutritional ranges of products by solicitation amendment, if variance is within normal scope of clinical use and/or a new product is offered which is outside the listed ranges. Offerors should notify the contracting officer within five business days of the posting of the solicitation for consideration of any products they want to offer that have nutrients outside the specified nutritional ranges.

8.5 Offeror must certify that all products proposed for Category IV should be packaged with

International Dysphagia Diet Standardization Initiative (IDDSI) labeling and must pass the syringe gravity flow test intended to confirm the beverage flow levels measured from 0 –4; 0-

Thin, 1- Slightly Thick, 2- Mildly Thick, 3 – Moderately Thick and 4 – Extremely Thick.

8.6 The contractor will, where possible, incorporate a sustainability plan which may include recycling and availability of locally grown and organic products. The contractor will, where possible, use packing materials which have the least impact on the environment when manufactured or disposed.

9.0 NATIONAL CONTRACT ITEM BACKORDERS

A contract awarded under this solicitation will be the Government’s primary source of supply.

(See FAR 52.216-21 Requirements Clause) The Government’s ability to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this section is to provide guidance to the awarded contractor regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, consideration of this section shall not waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4(m).

For purposes of this contract a backorder occurs when the PV issues an order with the awarded contractor for the products in this solicitation, and the complete order quantity is not delivered to the PV within 7 days after receipt of order. Backorder occurs for orders placed directly with the contractor when not delivered to the facility within 3-5 days after receipt of order. If a national contract item is backordered, the VA National Acquisition Center (NAC) contracting officer will investigate the backorder to determine if the contractor bears responsibility for the backorder.

The awarded contractor shall inform the VA NAC contracting officer within 4 calendar days after a backorder occurs. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backorder will be shipped and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved.

The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate a national contract backorder situation.

If the contracting officer determines that the contractor bears responsibility for the backorder, and the contractor is not able to provide a solution that is acceptable to the Government, (i.e., acceptable solution to the backorder, in lieu of Termination for Cause), the Government may buy against the contractor by acquiring the same or similar items from another source and billing the contractor for any excess procurement costs. In other words, if the Government must purchase product from another vendor because of a national contract backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the contract price. After a backorder incident occurs for which, the Contractor is responsible, the

Government’s decision to enter into a buy-against agreement described above will not deprive the

Government of its right under Clause 52.212-4(m) to terminate the contract for a breach of the buy-against agreement, for a subsequent contractor-caused backorder, or for any other sufficient cause.

10.0 COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

(a) Quarterly Sales Reports. The Contractor shall report all contract sales under this contract and submit collected Cost Recovery Fees as follows:

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March

31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies

(OGA). A Cost Recovery Fee equivalent to 0.5 % of the current contract price shall be collected from all contract users. The 0.5 % Cost Recovery Fee shall be imbedded in the awarded contract prices and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line-item price offered. The reported contract sales shall include the cost recovery fee and each quarterly report shall show the total cost recovery fee amount collected on the reported sales.

The Contractor shall maintain a consistent accounting method of sales reporting, based on the

Contractor’s established commercial accounting practice.

(2) Contract sales reports are due to the VA contracting officer within 30 calendar days following the completion of each reporting quarter or completion of the contract, whichever occurs first. A report is required even when no billings or invoices are issued, or no orders are received during the contract period.

(3) The sales report signed by an authorized representative of the contractor shall be sent by mail, email, or facsimile to the contracting officer. Emailed reports may be sent to the Contracting

Officer.

(4) In addition to the submission of quarterly sales reports due to the Contracting Officer within

30 days after the end of each reporting quarter, contractors shall provide copies of sales reports simultaneously with contractor’s cost recovery fee payment submissions via email:

AMMHINBOCFISCAL@VA.GOV

(b) The 0.5% Cost Recovery Fee amount shall be paid electronically via Collections Information

Repository (CIR)/Automated Clearing House (ACH). CIR/ACH credit instructions will be provided to the contractor upon contract award. When the contractor has multiple national contracts, the fee may be consolidated into one electronic payment. When the electronic payment is made, the contractor shall submit an email to AMMHINBOCFISCAL@VA.GOV to identify the contract number (or numbers, if the payment covered multiple contracts) included, dollar amount remitted for each contract number, and reporting quarter. The Cost Recovery Fee payment is due to the VA Fiscal Division at the same time the sales report is due to the

Contracting Officer (i.e., within 30 calendar days following the completion of each reporting quarter or completion of the contract).

mailto:AMMHINBOCFISCAL@VA.GOV mailto:AMMHINBOCFISCAL@VA.GOV

Cost Recovery Fee payments shall not be combined with any Industrial Fund Fee payments.

Contractors shall remit separately any Industrial Fund Fee payments in support of any of the

Contractor’s Federal Supply Schedule contracts.

(c) The Government reserves the right to inspect without further notice, such records of the

Contractor as pertain to sales under any contract resulting from this solicitation. Willful failure or refusal to furnish the required reports, or falsification thereof, shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions - Commercial

Items, Termination for Cause.

(d) Failure to remit the full amount of the Cost Recovery Fee within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the

Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the Cost

Recovery Fee, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

11.0 RECALLS

If a recall is initiated for any product provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug

Administration (FDA); or, if FDA withdraws their approval to manufacture any product that is included on this contract, the following action shall immediately be taken by the contractor:

Forward two copies of the recall notification along with any pertinent information to:

Ronald Jenkins

Chief, Prime Vendor Division (003A4CS)

VA National Acquisition Center

National Contract Service

1st Ave., 1 Block North of Cermak Rd., Bldg. 37

P.O. Box 76, Hines, IL 60141

Ronald.Jenkins3@va.gov

Deputy Chief Consultant (M/S119D)

VHA Pharmacy Benefits Management Services

1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139

Hines, IL 60141

Patientlevelrecalls@va.gov

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106

NCPS@va.gov.

Phone Number: (734) 930-5865

All Government Prime Vendors that were sent shipments of the affected product(s) shall also be provided a copy of the recall notification along with any pertinent information.

mailto:Ronald.Jenkins3@va.gov mailto:Patientlevelrecalls@va.gov mailto:NCPS@va.gov

12.0 MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

12.1 The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (GMP) standards for human drugs, pharmaceutical products, biologicals, medical devices, chemical products, medical cylinder oxygen, reagents, diagnostics, test kits and sets included in this solicitation. Only offers from companies that have an acceptable GMP status on record with the FDA for the facilities identified by the offeror in Paragraph

12.8 below will be considered for award. The FDA will evaluate a prospective offeror for VA procurements only if the offeror has had a qualifying GMP inspection within the previous two years.

Before a contract can be awarded, any successful offeror’s manufacturing facilities shall have a current acceptable GMP status (as applicable) with FDA or shall have had an acceptable report from the last FDA facility inspection on record. In the absence of a current GMP evaluation, an offeror is required to include with its proposal documentation on the acceptable outcome of an FDA facility inspection that occurred more than two years prior to submission of the offer.

12.2 For any Nutritional/Dietary Supplements offered, documentation of clinical studies that were performed on the offered products pertaining to the therapeutic treatment of patients may be required by the Department of Veterans Affairs National Acquisition Center (VANAC) as a quality assurance measurement. Offerors of Nutritional/Dietary Supplements will be required to adhere to published FDA

GMP standards after January 1, 2008.

12.3 If at any time during the life of the contract, the contractor’s facility (or the source from which the contractor obtains any of the products offered on this contract), or the facility that packages the product offered in this contract is notified of violations or potential violations by the FDA, is issued a Form FDA

483, or is issued an FDA Warning Letter highlighting a failure to meet FDA cGMPs (21 CFR Part 210 and 211), the awarded contractor shall inform the Contracting Officer within 15 calendar days of the notice. At which time, the Contracting Officer will apply the procedures outlined in Section 12.4 below.

Failure to notify the Contracting Officer within 15 days may result in a negative past performance rating and/or be grounds for contract termination in accordance with FAR 52.212-4(m), Contract Terms and

Conditions-Commercial Products and Commercial Services, Termination for Cause.

12.4. The Contracting Officer will review the contractor’s (or its source’s) unacceptable cGMP status with appropriate VHA clinical staff and will either: 1) instruct the contractor to stop the shipment of products listed on this contract that were manufactured and/or packaged in a facility with unacceptable cGMP status, or 2) authorize the contractor to continue to supply such contract products for 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, provided that the products have not been subjected to a consumer-level recall. An additional 90 calendar day extension may be authorized at the discretion of the Contracting Officer. Contractors are cautioned that products that were manufactured and /or packaged in a facility with unacceptable cGMP status and then shipped without written authorization from the Contracting Officer shall be returned to the contractor at the contractor’s risk and expense. The contractor shall have corrected all significant cGMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to unacceptable status by the end of the 90-calendar day authorization period and any extensions of such period granted by the Contracting Officer. Additionally, the contractor is responsible for keeping the Contracting Officer informed of all corrections made and shall provide the Contracting Officer with 1) written documentation of the correction plan, 2) Notification from FDA of acceptance of plan, and 3) a copy of any reinspection requests and subsequent reinspection reports, upon availability. If FDA’s evaluation of contractor’s (or its source’s) compliance efforts and/or re-inspection of the non-compliant facility does not result in an acceptable rating by the FDA within 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, or by the end of a Contracting Officer’s authorization period (whichever is the greater period of time), the contract may be terminated for cause in accordance with FAR 52.212-

4(m). The contractor’s (or its source’s) failure to correct the cGMP deficiencies in a timely manner shall not constitute or give rise to any “excusable delays” pursuant to FAR 52.212-4(f). (Nothing in this section shall be read as limiting the recognized grounds upon which a Contracting Officer may terminate this contract or delete products pursuant to the applicable sections contained in the contract.)

12.5 The contractor shall use only the FDA-inspected manufacturing facilities provided in Paragraph

12.8, below, for the duration of the contract, unless substitution of manufacturing facilities is approved by the VANAC Contracting Officer. In case of any manufacturing facility relocation or substitution of manufacturing facilities, the contractor shall notify the VANAC Contracting Officer of the change, and the contractor shall request approval from the VANAC Contracting Officer to supply the contracted products from the new location. If the change is approved by the VANAC Contracting Officer after an inquiry to FDA for GMP status of the new location, approval will be provided by means of a formal contract modification.

12.6 If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors

(i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be substantially in compliance with applicable FDA GMP standards prior to contract award.

12.7 Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered.

“Manufacturer” is defined as the entity that measures, mixes, weighs, and compounds the active and inactive ingredients into a capsule or tablet.

12.8 If the finished products to be offered are of foreign manufacture, the complete name and address of the manufacturer shall be provided below. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE

PRODUCTS OFFERED ON THIS SOLICITATION.

( ) OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE

FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

(FDA Establishment Identification [FEI] number of Manufacturing Company)

Dietary Supplements

Category Item # &

Product Name

Location and Owner of Facility where ingredients are measured, weighed, mixed and compounded

(Facility Owner Name, Address, City, County, State and Zip Code)

Point of Contact including

Phone #

OTHER PRODUCTS

(Solutions, syrups, mixtures, powders, ointments, pastes, creams, etc.)

Solicitation Item # &

Location and Owner of Facility where

Ingredients are measured, weighed, mixed and compounded (Facility

Owner Name, Address, City, County, State and Zip Code

PACKAGING

Location of Facilities where

Intermediate containers will be filled and labeled (Facility Name, Location, City, County, State and Zip Code)

PACKING

Location of Facilities where products will be packed and prepared for shipment (Facility Name, Location, City, County, State and Zip Code)

RFP 36W79725R0001

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,…