36E79723R0027.docx

36E79723R0027

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

36E79723R0027 08-21-2023 Deborah Fassl Deborah.Fassl@va.gov (708)786-5894 09-06-2023

2:30 PM CT

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 325412 1300 Employees N/A N/A X See Scope of Contract, Section 2.1 Complete delivery address to be shown on delivery orders Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141

Complete payment address to be shown on orders issued under this contract.

See CONTINUATION Page 2024-2025 Influenza Vaccine See Schedule of Supplies and Continuation of SF1449 See CONTINUATION Page X X X 1 scan

Continuation of SF-1449, Blocks 19 through 24:

All offered pharmaceuticals must be Food and Drug Administration (FDA) approved. FDA’s approval must be verifiable by the Contracting Officer as soon as FDA’s review is complete for the 2024-2025 Influenza season, which may be after the time for receipt of offers.

All vaccines shall be latex free.

All vaccines shall have an expiration date no earlier than May 31, 2025.

All vials must be individually boxed and must contain the bar code.

If the vaccine is not preservative free, please disclose the concentration of each preservative and, if available, the package label/insert. Additionally, please indicate the line item that corresponds with the package label/insert.

CDC recommendations and information can be found at Vaccines Licensed for Use in the United States | FDA.

Offerors are not required to submit an offer for every line item; however, the offeror must offer the full quantity for each line item offered. Please note that the Cost Recovery Fee (CRF) and Federal Excise Tax (FET) shall be added to the offered price. Additionally, the CRF (0.5% of offered price) is calculated before FET is added. Offeror(s) shall propose a price, not to exceed two decimal places, for every proposed line item for the duration of the contract. Multiple offers will be accepted.

Line Item 1

INFLUENZA VIRUS VACCINE

10 dose multiple dose vial, or 10 - 0.5ml Vials, Quadrivalent; 2024-2025 Influenza season; for persons ≥ 6 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(10 doses) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

Delivery will be made to VA Healthcare Facilities and State Veteran Homes (Option 2) as follows:

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 2

Pre-filled single dose Syringes with plunger and Luer lock needle attachment, Quadrivalent; 2024-2025 Influenza season; for persons ≥ 36 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 3

INFLUENZA VIRUS VACCINE

Pre-filled single dose syringe with plunger and Luer lock needle attachment, Trivalent or Quadrivalent; 2024-2025 Influenza season; must be specifically designed for persons 65 years and older as outlined by the CDC. (TABLE. Influenza vaccines — United States, 2022–23 influenza season* | CDC)

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 4

10 dose multiple dose vial, or 10 - 0.5ml Vials, Quadrivalent; 2024-2025 Influenza Season; for persons ≥ 6 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(10 doses) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

Delivery will be made to Bureau of Prisons (BOP) facilities as follows:

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 5

Pre-filled single dose Syringes with plunger and Luer lock needle attachment, Quadrivalent; 2024-2025 Influenza season; for persons ≥ 36 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 6

Pre-filled single dose syringe with plunger and Luer lock needle attachment, Trivalent or Quadrivalent; 2024-2025 Influenza season; must be specifically designed for persons 65 years and older as outlined by the CDC. (TABLE. Influenza vaccines — United States, 2022–23 influenza season* | CDC)

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 7

10 dose multiple dose vial, or 10 - 0.5ml Vials, Quadrivalent; 2024-2025 Influenza Season; for persons ≥ 6 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(10 doses) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

Delivery will be made to Indian Healthcare Services (IHS) facilities as follows:

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 8

Pre-filled single dose Syringes with plunger and Luer lock needle attachment, Quadrivalent; 2024-2025 Influenza season; for persons ≥ 36 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 9

Pre-filled single dose syringe with plunger and Luer lock needle attachment, Trivalent or Quadrivalent; 2024-2025 Influenza season; must be specifically designed for persons 65 years and older as outlined by the CDC. (TABLE. Influenza vaccines — United States, 2022–23 influenza season* | CDC)

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 10

Pre-filled single dose syringe with plunger and Luer lock needle attachment, Quadrivalent; 2024-2025 influenza season. Must be split virus vaccine (subvirion or purified surface antigen) that has been FDA approved and labeled with indications for administration to children 6 months - 35 months of age (pediatric), preservative free.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 11

Pre-filled single dose Syringes with plunger and Luer lock needle attachment, Quadrivalent; 2024-2025 Influenza season; for persons ≥ 36 months.

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

Delivery will be made to Captain James A Lovell Federal Health Care Center (FHCC)) as follows:

FHCC will have one delivery that shall be made between August 15, 2024, and September 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Line Item 12

INFLUENZA VIRUS VACCINE

Pre-filled single dose syringe with plunger and Luer lock needle attachment, Trivalent or Quadrivalent; 2024-2025 influenza season; must be specifically designed for persons 65 years and older as outlined by the CDC. (TABLE. Influenza vaccines — United States, 2022–23 influenza season* | CDC)

NDC # __________________

2024 Provisional Federal Ceiling Price $__________________

(Syringe) Unit Price (Inclusive of Federal Excise Tax and Cost Recover Fee) Total Amount (Inclusive of Federal Excise Tax and Cost Recover Fee)

Delivery will be made to Captain James A Lovell Federal Health Care Center (FHCC)) as follows:

FHCC will have one delivery that shall be made between August 15, 2024, and September 15, 2024.

(See SECTION B - CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES, for further delivery instructions.)

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

Please be advised the following are included in the solicitation and are highlighted here.

Evaluation and award will be made by solicitation line item. Offerors are not required to submit an offer for every line item; however, the offeror must offer the full quantity for each line item offered. Please note that the final offered price must include the Cost Recovery Fee and Federal Excise Tax (FET). The Cost Recovery Fee (0.5% of offered price) is calculated before FET is added. Offeror(s) shall propose a price, not to exceed two decimal places, for every offered line item. Awarded prices shall be in effect for the duration of the contract. Offerors shall provide an NDC number unique to the manufacturer for each item proposed by the solicitation prior to award. “Manufacturer” is defined as the entity that holds the biological license to cultivate, purify, and formulate the vaccine in accordance with FDA manufacturing standards. Offers that fail to provide this information by the solicitation closing date may be rejected and receive no further consideration.

Proposals will be accepted in Microsoft Word or PDF form via e-mail at Deborah.Fassl@va.gov with a scanned (pdf) copy of the signed SF-1449. Please note that faxed proposals are not acceptable and will be rejected. Additionally, zip files and folders are rejected by Department of Veterans Affairs (VA) National Acquisition Center (NAC) servers, and emails with large attachments may not be received. VA suggests that offerors submit their proposals well before the deadline and confirm receipt of all attachments with the Contracting Specialist listed on the SF-1449. Reference Federal Acquisition Regulation (FAR) 52.212-1(f) regarding timeliness of submission of offers.

The Government will evaluate offers in accordance with the policies and procedures of the FAR Part 12, Part 15, and Part 25.

ITEMS 1 through 10 WILL BE AWARDED UNDER FIRM-FIXED PRICE INDEFINITE DELIVERY, REQUIREMENTS TYPE CONTRACT(S).

(Please refer to FAR clauses 52.216-21 Requirements, 52.216-18 Ordering, 52.216-19 Order Limitations, and 52.247-34 FOB Destination).

1. Contractor(s) shall accept all Department of Veterans Affairs (VA), State Veteran Homes Option 2 (SVH2), Bureau of Prisons (BOP), and Indian Health Service (IHS) orders for line items 1 through 10 from date of contract award through April 15, 2024, unless a later ordering deadline is offered in the contractor’s proposal and is mutually agreed upon between the contractor and the Government. The contractor may, but is not required, to accept orders placed under this contract by VA, SVH2, BOP, and IHS facilities after the specified ordering deadline of April 15, 2024, through the contract expiration date of March 14, 2025. All vaccines will have an expiration date no earlier than May 31, 2025.

2. Orders will be placed by and delivered to VA, SVH2, BOP, and IHS facilities throughout the United States, the Philippines, and Puerto Rico. Delivery will be required to be made to VA, SVH2, IHS, and BOP in two shipments, unless the ordering facility requests that all items are delivered in a single shipment. The first shipment of product ordered must be at least 50% of each individual facility’s ordered quantity and must be delivered between August 15, 2024, and September 15, 2024. The second shipment must be for the remaining individual facility’s entire ordered quantity and must be delivered between September 16, 2024, and October 15, 2024. After award of contract, the awardee must abide to the established delivery schedule.

NOTE: Contractor(s) will be required to send confirmation of each order placed by VA, SVH2, BOP, and IHS facilities by either email, facsimile, or on-line ordering confirmation within two business days after receipt of order to each individual ordering facility.

ITEMS 11 through 12 WILL BE AWARDED UNDER FIRM-FIXED-PRICE, DEFINITE QUANTITY TYPE CONTRACT(S).

(Please refer to FAR clause 52.247-34 FOB Destination)

1. The delivery orders for these definite quantities will be issued at the time of award by Captain James A. Lovell Federal Healthcare Center (FHCC). The awarded quantities shall be delivered to the FHCC location specified in Section B, Schedule of Supplies/Services in a single delivery between August 15, 2024, and September 15, 2024. All vaccines will have an expiration date no earlier than May 31, 2025.

2. 100% of the awarded quantities shall be delivered to Captain James A. Lovell Federal Healthcare Center (FHCC), 3001 Green Bay Road, Building 138, North Chicago, IL 60064, between August 15, 2024, and September 15, 2024.

The System for Award Management (SAM) is the Official U.S. Government system for registering to do business with the federal government, completing company representations and certifications, listing contract opportunities, and more. Contractors should go to www.sam.gov to find their information. Training tools are available on the SAM website for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually.

Subcontracting Plan Requirements: Pursuant to the requirements of 15 U.S.C. § 644, all large business concerns are required to have an approved subcontracting plan for contracts valued over $750,000 before the Government can award a contract (see FAR 52.219-9 and VAAR 852.219-70 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment “C” includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan.

As prescribed in FAR Subpart 42.15, VA evaluates contractor performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).

Acknowledgement of Amendments. The following amendments are acknowledged as part of this solicitation. (Please complete if applicable)

SCOPE OF CONTRACT

1. INTRODUCTION

1.1 Background. The Influenza Vaccine is procured annually as the prices and production vary from year to year based on a variety of data, including epidemiology, genetic data, antigen etymology, human serology studies, evolutionary analysis and data integration, and vaccine effectiveness studies. The World Health Organization reviews the world epidemiological situation twice annually and, if necessary, recommends new vaccine strain(s) in accordance with the available evidence for the following Influenza season. The VA, BOP, IHS, SVH2 and FHCC will acquire their Influenza vaccine requirements directly from contractor(s) awarded a contract resulting from this solicitation. Contract(s) resulting from this solicitation will establish the Federal Government prices for the above-referenced agencies for the products listed in the Schedule of Supplies that will be distributed by the awarded contract sources. The successful contractor shall be required to be compliant with all appropriate requirements as implemented in the Drug Supply Chain Security Act (DSCSA). See Section 6 of the Scope of Contract for DSCSA details.

1.2 Purpose and Objectives. The purpose of this solicitation is to establish sources of supply that will provide the products listed in the Schedule of Supplies for purchase directly from the awarded contractor(s) (“Contractor”). The objective of such a contract(s) is to ensure availability and distribution of the 2024-2025 Influenza vaccines to all participants identified, within the specified delivery time frame, and at committed use prices.

1.3 Government Purchase Compliance. Individual VA, SVH2, BOP, and IHS facilities will purchase their requirements by placing orders for the products listed in the schedule directly from the awarded contractor(s) except for: Influenza vaccines provided to VA patients through the VA Community Care Network. In the event that this instance occurs, it will be considered an exception to 52.216-21, Requirements.

FHCC will issue delivery orders for the definite quantities listed in Schedule of Supplies, at the time of award. Products awarded under this contract are for use by the Government agencies listed in the Schedule of Supplies and shall not be subject to resale for commercial purposes.

1.4 Contract Duration. The contract resulting hereunder will be in effect from the contract award date through March 14, 2025. Pre-book periods and delivery timeframes are specified in in Section B, Schedule of Supplies/Services, pages 11-12.

2. EXTENT OF OBLIGATION

2.1 Government Participants. The contractor shall provide the products specified in the schedule at the prices awarded herein for the facilities/agencies below:

· All Department of Veterans Affairs (VA) facilities

· All Indian Health Service (IHS) facilities

· All Bureau of Prisons (BOP) facilities

· Captain James A. Lovell Federal Health Care Center (FHCC)

· All Option 2 State Veteran Homes (See Section 2.2 State Veteran Homes)

a. All VA facilities, including Consolidated Mail Order Pharmacies, and Emergency Pharmacy Service (Line items 1-3; orders will be placed directly by the individual facilities at time of award through contract ordering deadline).

VA Facilities Authorized to Place Orders for Contract Items 1 through 3 can be accessed at https://www.va.gov/directory/guide/rpt_fac_list.cfm

b. All BOP facilities (Line items 4-6; orders will be placed directly by the individual facilities at time of award through contract ordering deadline).

BOP Facilities Authorized to Place Orders for Contract Items 4 through 6 can be accessed at BOP: Our Locations

c. IHS National Supply Service Center in Oklahoma City, OK and Indian Medical Center in Phoenix, AZ (Line items 7-10; orders will be placed directly by the individual facilities at time of award through contract ordering deadline)

d. Option 1 State Veterans Homes are 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.

e. Option 2 State Veterans Homes (SVH2) - The VA Medical Center (VAMC) authorizes the SVH2 to place orders, and the VAMC makes payment for all products ordered by the SVH2. (Line items 1-3; orders will be placed by individual SVHs at time of award through contract ordering deadline).

f. FHCC - Delivery to: 3001 Green Bay Road, Building 138, North Chicago, IL 60064 (Line items 11- 12; orders will be issued for these definite quantities and provided at the time of award).

2.2 Quantities. The estimated quantities listed in the solicitation for items 1-10 reflect the estimated usage of VA (including SVH2), BOP, and IHS facilities. There is no expressed or implied guarantee that the estimated quantities will be purchased under this contract(s). Actual quantities purchased may exceed or be less than those represented. Orders that specify the exact quantities and delivery locations will be placed by individual VA, SVH2, BOP, and IHS facilities by the ordering deadline specified in the contract. The Contractor must accept all delivery orders from VA, SVH2, BOP, and IHS facilities that are received by the ordering deadline for quantities that are within the limitations specified in clause 52.216-19, Order Limitations. See also 52.216-18, Ordering and 52.216-21, Requirements.

The quantities listed in the solicitation for items 11-12 reflect the actual quantities that will be ordered by issuance of delivery orders placed against resultant contract(s) at the time of award.

3. REPORTING REQUIREMENTS

3.1 Report of Orders Received (applicable to line items 1 through 10). Starting March 1, 2025, the awarded contractor(s) shall furnish a separate report in an Excel spreadsheet via email per agency of orders received to date for VA, SVH2, BOP, and IHS facilities. An updated version of the report shall be furnished every two weeks until the ordering deadline (April 15, 2025, unless a later ordering deadline is offered in the contractor’s proposal and is mutually agreed upon between the contractor and the Government). Should any orders be received after the ordering deadline, an updated version of the report shall be furnished. The report shall include at a minimum, divided by column or row: agency, facility account number, facility name and address and provide the NDC number and quantity ordered by each facility under the resultant contract(s). For line items 1 through 3 (VA), the report shall include the VA VISN and VA Facility Station Numbers as provided in the Influenza vaccine ordering procedures (See paragraph 3.4 for details; the VA facility station numbers can be accessed at https://www.va.gov/directory/guide/rpt_fac_list.cfm). This report shall be sent to the Contracting Officer, at the following e-mail address: Deborah.Fassl@va.gov or to another Contracting Officer if designated by VA.

3.2 Report of Scheduled Deliveries (applicable to all line items). The awarded contractor(s) shall furnish to the Contracting Officer, a report in an Excel spreadsheet via email that separately identifies the orders for each entity of all expected vaccine deliveries to VA, SVH2, BOP, IHS, and FHCC facilities no later than five business days before each actual delivery. These reports shall include at a minimum, divided by column or row: agency, facility account number, facility name, address, NDC number, shipment dates and approximate quantities. For items 1 through 3 (VA), this report shall include the VA VISN and VA Facility Station Numbers as provided in the Influenza vaccine ordering procedures (See paragraph 3.4; VA station ID numbers are located at Facility Listing - Locations (va.gov)). This report shall be sent to the Contracting Officer, at the following e-mail address: Deborah.Fassl@va.gov or to another Contracting Officer, if designated by VA. Once the Contractor has provided the Contracting Officer with a shipping schedule, any deviations to that schedule must be reported to the Contracting Officer immediately, and in writing, as any deviations will have a significant impact on scheduled VA and Other Government Agencies (OGA) Influenza clinics. No delivery shall be made prior to 8:00am and no later than 2:00pm (local time). Please note that no deliveries shall be made on weekends or Federal holidays.

3.3 Report of Actual Deliveries (applicable to all line items). The awarded contractor(s) shall furnish a weekly delivery report in an Excel spreadsheet separated by VA, SVH2, BOP, IHS, and FHCC facilities to the Contracting Officer via email for all shipments made. These reports shall be provided upon initial shipment and continue on a weekly basis until all vaccines are delivered. These reports shall include at a minimum, divided by column or row: agency, facility account number, facility name, shipping address, and provide the NDC number, quantity shipped, and tracking number for each shipment. For line items 1 through 3 (VA), these reports shall include VA VISN and VA Facility Station Number as indicated in the Influenza vaccine ordering procedures (Please see paragraph 3.4). This report shall be sent to the Contracting Officer, at the following e-mail address: Deborah.Fassl@va.gov or to another Contracting Officer, if designated by VA.

3.4 Ordering Information (applicable to line items 1-10). The awarded contractor(s) shall provide proposed ordering information procedures with their proposal, to allow individual facilities to place their orders. Finalized ordering information procedures must be provided to Deborah.Fassl@va.gov or to another Contracting Officer, if designated by VA, within three (3) business days after award via email. Orders may be accomplished through on-line ordering, email, or by facsimile. Ordering information shall include at a minimum: contract number, contract price, NDC number, product description, quantity ordered, and customer ship to and billing information. The ordering procedures must also include a field for customer information, including facility station number (VA station ID numbers are located at Facility Listing - Locations (va.gov)). Please note that contractor(s) are required to provide order confirmation to the ordering facility for each order placed by either email, facsimile, or on-line confirmation within two (2) business days after receipt of order.

3.5 Delivery Information (applicable to all line items). The awarded contractor(s) shall provide delivery confirmation to the ordering facility for each order placed by either email or on-line confirmation within three (3) business days prior to scheduled delivery to allow individual facilities appropriate time to coordinate receipt of product.

· No delivery shall be made prior to 8:00am and no later than 2:00pm (local time).

· No deliveries shall be made on weekends or Federal Holidays.

· The Influenza Vaccine must be refrigerated in accordance with FDA guidelines/approval, to maintain efficacy.

· Packaging on deliveries shall clearly indicate “refrigerated product.”

4. PACKAGING REQUIREMENTS

Offerors must state the exact name and strength of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number for all items offered; the NDC number must be specific to the manufacturer and to the drug being supplied.

5. BAR CODING

All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GS1 or HIBCC HIBC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.

The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS), or Universal Product Code (UPC) (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN).

The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this section prior to shipping pharmaceutical products to any Government Prime Vendor under this contract.

The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap must contain the bar code.

If applicable, the bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.

When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. The Drug Supply Chain Security Act (DSCSA) now requires a two-dimensional data matrix bar code (GS-1 data matrix bar code preferred) for each product down to the lowest saleable package size (see Section 7, below, for additional DSCSA requirements); however, the Food and Drug Administration (FDA) bar code rule for linear bar codes still applies to all packaging as stated above. A human readable number must be placed adjacent (preferably below) the encoded bar code to ensure product is usable with VA Bar Code Medication Administration (BCMA) in the event the bar code is in some way damaged.

It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date; the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Alliance (HDA) guidelines (formerly HDMA) shall be followed.

6. DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) REQUIREMENTS

Title II of the Drug Quality and Security Act (DQSA), known as the DSCSA, applies to all drug products, with the exception of those listed on the DSCSA exemption list: Title II of the Drug Quality and Security Act | FDA. As part of the requirement of the DSCSA, drug products are required to provide serialized DSCSA Transaction Information and Transaction Statements using GS1 industry standard Electronic Product Code Information Services (EPCIS) files following the GS1 US Implementation Guideline: The GS1 US DSCSA Implementation Suite (gatewaychecker.com) in order to transmit the files needed for tracking.

DSCSA also requires that all trading partners of manufacturers, wholesale distributors, dispensers, and repackagers meet applicable requirements for being authorized trading partners. The National Association of Boards of Pharmacy (NABP) has established a trading partner directory, which is a repository of authorized trading partners that can be accessed to authenticate authorized trading partners in real time. All VA and other participating agency pharmacies will be entered in this directory as authorized trading partners using unique identifiers. Current and prospective trading partners of the VA other participating agencies are required to complete a registration prior to selling pharmaceuticals to these agencies. Neither the Government, nor the vendors will be charged a fee to participate in the directory.

DSCSA drug products are required to provide the serialized DSCSA Transaction Information and Transaction Statement required for the interoperable electronic DSCSA system using GS1 industry standard EPCIS files following the GS1 US Implementation Guideline. Suppliers establishing an EPCIS connection for DSCSA will need to inform their trading partners of the master data for the Global Trade Item Number (GTIN) and Global Location Numbers (GLNs) that they utilize. These are necessary to establish the EPCIS connection in addition to being able to transmit the file using AS2 or another method. Suppliers are encouraged to do this onboarding very soon as product may not be purchased or sold without the serial DSCSA Transaction Information in late 2023. Registration and valid status in the National Association of Boards of Pharmacy (NABP) Trading Partner Directory is required also for all VA contract holders pursuant to DSCSA.

7. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct eleven-digit NDC Number unique to the manufacturer (e.g., 00012-3456-78) for each product proposed, in the space provided following each item in block 20 of the SF-1449, “Schedule of Supplies and Prices” of the solicitation. The first five numbers of the eleven-digit NDC number for each product proposed shall identify the manufacturer. Offers that fail to provide the information required by this clause by the solicitation closing date may be rejected and receive no further consideration.

8. NEW DRUG APPLICATION

All offered pharmaceuticals must be Food and Drug Administration (FDA) approved. FDA’s approval must be verifiable by the Contracting Officer as soon as FDA’s review is complete for the 2024/2025 season, which may be after the time for receipt of offers. By signing this solicitation, the offeror certifies that it will have on file (if any of the following are required by FDA for the offered drugs) an FDA-approved New Drug Application (NDA), an approved Abbreviated NDA (ANDA), or an approved Biologic License Application (BLA), as appropriate for the items offered in response to the solicitation. Failure to obtain the appropriate FDA approvals in time to meet contract delivery requirements may result in contract termination in accordance with FAR 52.212-4(m) Termination for Cause. Contractor(s) will obtain any FDA-required vaccine batch approvals prior to making any deliveries under the resultant contract.

9. RECALLS

If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the FDA; or, if FDA withdraws its approval to manufacture any drug that is included on this contract, the contractor shall immediately forward two copies of the recall notification along with any pertinent information to:

Erika Moreno Chief, Pharmaceutical Division (003B6C3) VA National Acquisition Center National Contract Service 1st Ave., 1 Block North of Cermak Rd., Bldg. 37 P.O. Box 76, Hines, IL 60141 Erika.Moreno2@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 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5890

10. COVERED DRUGS

Should a covered drug (as defined in 38 U.S.C. § 8126(h)(2)) be proposed and awarded as a result of this solicitation, the awarded prices shall meet the requirements of 38 U.S.C. § 8126 and shall apply to all Government participants listed in Section 2.1 of the Scope of Contract, regardless of whether the participant is covered under the law. Therefore, prices for the base year shall not exceed the annually established Federal Ceiling Price (FCP), plus the 0.5% Cost Recovery Fee (CRF) and Federal Excise Tax (FET).

Attention is directed to the fact that although 38 U.S.C. § 8126 applies to all covered drugs, competitively negotiated and awarded prices for the base year by the Government will govern unless the annually established FCP results in a price lower than competitively awarded contract prices. In this instance, the contract shall be modified to reflect the lower annually established FCP, plus the 0.5% CRF and Federal Excise Tax (FET).

Both parties (Offeror and VA) understand the VA National Contract Service will obtain FCPs from VA’s Pharmacy Benefits Management (PBM). The parties agree the FCP will be calculated pursuant to the requirements of 38 U.S.C. § 8126 and any related requirements contained in the contractor’s Master Agreement, Pharmaceutical Pricing Agreement, and relevant VA Dear Manufacturer Letters. Refer to the VA Federal Supply Schedule (FSS) website at https://www.fss.va.gov/ and Public Law 102-585 (Veterans Health Care Act of 1992) page on the VA FSS website at https://www.va.gov/opal/nac/fss/publicLaw.asp for further information and a list of published Dear Manufacturer Letters.

Contractors submitting a proposal for a covered drug are required to complete the following paragraph:

MASTER AGREEMENTS AND PHARMACEUTICAL PRICING AGREEMENTS

In compliance with 38 U.S.C. 8126, Public Law 102-585, Section 603 - The Veterans Healthcare Act of 1992, offerors of covered drug products (including biologics) must state below whether they currently have a Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA) in place with the Department of Veterans Affairs (VA).

_____ YES, Offeror has a MA and PPA in place with the VA _____ NO, Offeror does not have a MA and PPA in place with the VA.

If the answer to the above is "NO" and if the prospective contractor is offering covered drug products (including biologics that fall within 21 CFR 600.3), contractor must submit and execute a MA and PPA with its offer. No offer of covered drugs submitted by a manufacturer will be considered for award unless and until the manufacturer has on file with VA's National Acquisition Center an executed MA and PPA.

Offerors of Influenza vaccine shall comply with Department of Veterans Affairs guidance contained in the "Dear Manufacturer letter” (DML) dated March 31, 2004 (or most current). This Federal Ceiling Price (FCP) guidance for the Influenza vaccine was issued pursuant to the above Public Law and shall apply to the 2024-2025 Influenza season.

Provisional FCPs under the DML must be established and known by VA prior to award, and the awarded prices shall not exceed the current Provisional FCPs for the offered products, found in the records of VA's Pharmacy Benefit Management Services (PBM) FCP Data Base.

If, after the time of award, a Provisional FCP is revised pursuant to the DML, the following requirements apply:

(1) Upon making any revision to the Provisional FCP, the contractor shall so notify the Contracting Officer in writing by no later than 10 calendar days of the revised provisional FCP filed with VA PBM.

(2) If the contract price is higher than the revised Provisional FCP, the contract price shall be reduced by unilateral modification to the revised Provisional FCP.

11. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

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

(A) 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.

(B) Contract sales reports are due to the Contracting Officer within 60 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.

(C) The sales report signed…