36E79718R0047-001.docx

36E79718R0047

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.

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

36E79718R0047 12-04-2018 Bonita Smith 708-786-5175 12-12-2018

2:30 P.M. CT

Department of Veterans Affairs OA&L / National Acquisition Center Building 37, NCS (003A4C4) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 325412 1250 Employees N/A N/A X See continuation sheet of SF1449.

Complete delivery address to be shown on delivery orders

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

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

See CONTINUATION Page 2019-2020 Influenza Virus Vaccine See CONTINUATION Page X X One 19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

1.

2.

Influenza Virus Vaccine: 10 dose multiple dose vial, OR 0.5ml vial; Quadrivalent; whole or split virus; 2019-2020 influenza season; FDA approved for persons 18 years and older. Latex Free.

NDC __________________________________

2018 Provisional Federal Ceiling Price:

Delivery: Delivery will be made to VA healthcare facilities and State Veteran Homes (Option 2) as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019 – October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions)

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock needle attachment, Quadrivalent; 2019-2020 influenza season; FDA approved for persons 18 years and older. Packaged in boxes of 10 syringes.

Product including device (i.e. Syringe, plunger, or cap of drug) NOTE: Pre-filled single dose syringe with any type of needle attached is not acceptable.

NDC _________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to VA healthcare facilities and State Veteran Homes (Option 2) as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019– October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Information Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available. Latex Free: ______Yes _____No 16,500 10-dose vials

OR

165,000 1-dose vials (estimated)

200,000 (estimated) Multiple-Dose Vial

OR

Single-Dose Vial

Box (10 syringes per box)

(inclusive of Federal Excise Tax and the Cost Recovery Fee)

Item No.

Schedule of Supplies Quantity Unit Unit Price Amount

3.

4.

5.

6.

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Trivalent or Quadrivalent; 2019-2020 influenza season; Must be specifically designed for people 65 years and older as outlined by the CDC. Product including device (i.e. Syringe, plunger, or cap of drug); packaged in boxes of 10 syringes https://www.cdc.gov/flu/about/disease/65over.htmNOTE: Pre-filled single dose syringe with any type of needle attached is not acceptable.

NDC _________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to VA healthcare facilities and State Veteran Homes (Option 2) as follows: 50% between August 15, 2019 – September 15, 2019; 50% between September 16, 2019– October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Information Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available.

Latex Free: ______Yes _____No Influenza Virus Vaccine: 10 dose multiple dose vial, OR 0.5ml vial Quadrivalent; whole or split virus; 2019-2020 influenza season; FDA approved for persons 18 years and older. Latex Free.

NDC __________________________________

2018 Provisional Federal Ceiling Price:

Delivery: Delivery will be made to Bureau of Prisons (BOP) facilities as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019– October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock needle attachment, Quadrivalent; 2019-2020 influenza season; FDA approved for persons 18 years and older.

Product including device (i.e. Syringe, plunger, or cap of drug) NOTE: Pre-filled single dose syringe with any type of needle attached is not acceptable.

NDC _________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to Bureau of Prisons (BOP) facilities as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019– October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Information Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available.

Latex Free: ______Yes _____No

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Trivalent or Quadrivalent; 2019-2020 influenza season; Must be specifically designed for people 65 years and older as outlined by the CDC.

Product including device (i.e. Syringe, plunger, or cap of drug) NOTE: Pre-filled single dose syringe with any type of needle attached is not acceptable.

NDC _________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to the Bureau of Prison (BOP) facilities as follows: 50% between August 15, 2019 – September 15, 2019; 50% between September 16, 2019– October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Information Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available.

Latex Free: ______Yes _____No

51,000

6,000

OR

60,000

4,000 (estimated)

Box (10 syringes per box)

Multiple-Dose Vial

OR

(10 Syringes per box)

Box (10 Syringes per box)

7.

8.

9.

10.

11.

12.

Influenza Virus Vaccine: 10 dose multiple dose vial, OR 10 0.5ml vial Quadrivalent; whole or split virus; 2019-2020 influenza season; FDA approved for persons 18 years and older.

Latex Free.

NDC __________________________________

2018 Provisional Federal Ceiling Price:

Delivery: Delivery will be made to Indian Healthcare Services (IHS) facilities as follows: 50% between August 15, 2019 – September 15, 2019; 50% between September 16, 2019 – October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions)

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Trivalent or Quadrivalent; 2019-2020 influenza season; Must be specifically designed for people 65 years and older as outlined by the CDC.

NDC __________________________________

2018 Provisional Federal Ceiling Price:

Delivery: Delivery will be made to Indian Healthcare Services (IHS) facilities as follows: 50% between August 15, 2019 – September 15, 2019; 50% between September 16, 2019 – October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Informational Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available.

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Quadrivalent; whole or split virus; 2019-2020 influenza season. FDA approved and labeled with indications for administration to children 36 months and older.

NOTE: Pre-filled single dose syringe with any type of needle attachment is not acceptable.

NDC __________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to Indian Healthcare Services (IHS) healthcare facilities as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019 – October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) For Information Purposes Only:

Preservative Free: _____Yes _____ No If not preservative free, please disclose the concentration of each preservative and package insert if available.

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Quadrivalent; 2019-2020 influenza season. Must be a split virus vaccine (subvirion or purified surface antigen) that has been FDA approved and labeled with indications for administration to children 6 months to 35 months of age (pediatric), preservative free.

NOTE: Pre-filled single dose syringe with any type of needle attachment is not acceptable.

NDC __________________________________

2018 Provisional Federal Ceiling Price Delivery: Delivery will be made to Indian Healthcare Services (IHS) healthcare facilities as follows: 50% between August 15, 2019– September 15, 2019; 50% between September 16, 2019 – October 15, 2019. (See Scope of Contract, Paragraph 2 for further delivery instructions) Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Quadrivalent; 2019-2020 influenza season; FDA approved for persons 18 years and older.

NOTE: Pre-filled single dose syringe with any type of needle attached is not acceptable.

NDC __________________________________

2018 Provisional Federal Ceiling Price:

Delivery Locations:

Federal Healthcare Center Delivery: Entire quantity by September 15, 2019

Influenza Virus Vaccine: Pre-filled single dose syringe with plunger and luer lock attachment, Trivalent or Quadrivalent; 2019-2020 influenza season; Must be specifically designed for people 65 years and older as outlined by the CDC

NDC _________________________________

2018 Provisional Federal Ceiling Price Delivery Locations:

Federal Healthcare Center Delivery: Entire quantity by September 15, 2019

13,524

OR

135,240 Single vial

3,640

21,233

(Fixed Quantity)

(Fixed Quantity) Multiple-Dose Vial

OR

Box (10 Syringes per box)

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

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 Cost Recovery Fee shall be added to the offered price inclusive of the Federal Exercise Tax. 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 a 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 to FDA manufacturing standards. Offers that fail to provide this information by the solicitation closing date may be rejected and receive no further consideration. Please refer to the Scope of Contract and Instruction to Offerors sections of this solicitation.

Proposals may be delivered to Department of Veterans Affairs (VA), National Acquisition Center, National Contract Service (36B6B3), 1st Avenue, 1 Block North of Cermak Road, Building 37, Hines, IL 60141. Proposals will also be accepted in Microsoft Word or PDF form via e-mail at Bonita.Smith@va.gov with a scanned, signed copy of the SF 1449. E-mail proposals must be received at the e-mail inbox of Bonita.Smith@va.gov by the date and time specified in Block 8 of the SF1449. Please note that faxed proposals are not acceptable and will be rejected. Reference FAR clause 52.212-1(f) regarding timeliness of submission of offerors.

ITEMS 1 through 10 WILL BE AWARDED UNDER 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 VA, State Veteran Homes Option 2 (SVH), Bureau of Prisons (BOP), and Indian Health Service (IHS) orders for line items 1 thru 10 from date of contract award through March 31, 2019 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, SVH, BOP, and IHS facilities after the specified ordering deadline of March 31, 2019, through the contract expiration date of March 31, 2020. All vaccines shall have a shelf life (expiration date) of no less than 9 months from the ship date.

2. Orders will be placed by and delivered to VA, SVH Option 2 (SVH), BOP, and IHS facilities throughout the United States, the Philippines and Puerto Rico. Delivery shall be made to VA, SVH Option 2, BOP, and IHS in one but no more than two shipments of each of the individual facility’s total requirements. The first shipment of product ordered must be for 100% or 50% of an individual facility’s ordered quantity and must be shipped between August 15, 2019 and September 15, 2019. If a second shipment is required, it must be for the remaining 50% of an individual facility’s entire ordered quantity and must be shipped between September 16, 2019 and October 15, 2019. 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, SVH, 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 DEFINITE QUANTITY, DEFINITE DELIVERY 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), through the National Acquisition Center. The awarded quantities shall be delivered to the FHCC location specified in the schedule of supplies/services by the delivery date specified in the schedule of supplies. All vaccines shall have a shelf life (expiration date) of no less than 9 months from the ship date.

2. 100% of the awarded quantities shall be delivered to Captain James A. Lovell Federal Healthcare Center (FHCC between August 15, 2019 and September 15, 2019. After award of contract, any deviation from the above delivery schedule will require reasonably equal treatment between orders shipped under this contract and any other contractor’s customers with respect to the fulfillment of orders.

The System for Award Management (SAM) is an online system that replaces CCR/FedReg, ORCA, and EPLS. Contractors should now go to www.sam.gov to find their information. Training tools are available on the SAM website at www.sam.gov for familiarization with the SAM system. 52.204-7 System for Award Management (b)(1) requires an offeror to be registered in SAM when submitting an offer or quotation, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. 52.204-13 System for Award Management Maintenance(c) requires the Contractor to maintain registration in SAM during contract performance and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement. The Contractor is responsible for the currency, accuracy and completeness of the data within SAM, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in SAM after the initial registration, the Contractor is required to review and update on an annual basis, from the date of initial registration or subsequent updates, its information in SAM to ensure it is current, accurate and complete. Updating information in SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

Subcontracting Plan Requirements: Pursuant to the requirements of 15U.S.C.644, all large business concerns are required to have an approved subcontracting plan for contracts valued over $700,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment D.1 i includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan. Note: The dollar value of $150,000 provided in paragraph (d) (11) (iii) of 52.219-9 which is incorporated by reference at 52.212-5(b) (17) (iii)] is revised to $250,000 in accordance with VA Class Deviation dated March 22, 2018.

As prescribed in FAR Part 42.15, VA evaluates contractor performance on all contracts that exceed the Simplified Acquisition Threshold, which was raised to $250,000, by a VA Class Deviation dated March 22, 2018, 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).

SCOPE OF CONTRACT

1. INTRODUCTION

1.1 Background. Influenza Vaccine is procured annually as the prices and production are volatile from year to year. Twice annually, the World Health Organization analyzes the global data on circulating influenza strains and issues recommendations on the formulation of the influenza vaccine for the following influenza season. The Department of Veterans Affairs (VA), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (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 Drug Supply Chain Security Act (DSCSA).

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). The objective of such a contract(s) is to ensure availability and distribution of the 2019-2020 flu vaccines to all participants identified, within the specified delivery time frame, committed use prices.

1.3 Government Purchase Compliance. Individual VA, BOP, and IHS facilities will purchase their requirements by placing orders for the products listed in the schedule direct from the awarded contractor(s). FHCC will issue delivery orders for the definite quantities listed in the 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(s) resulting from this solicitation will be in effect from the date of contract award through March 31, 2020.

2. EXTENT OF OBLIGATION

2.1 Government Participants. The contractor shall deliver the products specified in the schedule at the prices awarded herein to the facilities authorized to place orders below:

a. All Department of Veterans Affairs (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 http://www1.va.gov/directory/guide/rpt_fac_list.cfm?isflash=0

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

Bureau of Prisons Facilities Authorized to Place Orders for Contract Items 4 through 6 can be accessed at www.bop.gov/DataSource/execute/dsFacilityLoc

c. Indian Health Service (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 (SVH) 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 (SVH) - The VAMC authorizes the SVH to place orders, and the VAMC makes payment for all products ordered by the SVH. (Line items 1-3; orders will be placed by individual facilities at time of award through contract ordering deadline).

f. Captain James A. Lovell Federal Health Care Center, (Delivery to: 510 B. Street Building 81H, Great Lakes, IL (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 Option 2 State Veterans Homes, BOP, and IHS facilities. There is no expressed or implied guarantee that the estimated quantities will be purchased under these 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, SVH Option 2, BOP, and IHS facilities by the ordering deadline specified in the contract. The contractor must accept all delivery orders from VA, 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). Two weeks before the mutually agreed upon ordering deadline, the awarded contractor(s) shall furnish a separate report of orders received to date for VA, SVH Option 2, BOP, and IHS facilities. The report (Excel spreadsheet) shall include at a minimum: 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 and attached excel spreadsheet for VA Facility Station Numbers). This report shall be sent to the Contracting Officer, at the following e-mail address: Bonita.Smith@va.gov

3.2 Report of Scheduled Deliveries (applicable to all line items). The awarded contractor(s) shall furnish to the Contracting Officer, a report that separately identifies the orders for each entity of all expected vaccine deliveries to VA, SVH Option 2, BOP, IHS, and FHCC facilities no later than five days before each actual delivery. These reports (Excel Spreadsheet) shall include at a minimum: 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 and attached excel spreadsheet for VA Facility Station Numbers). This report shall be sent to the Contracting Officer, at the following e-mail address: Bonita.Smith@va.gov. 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 OGA flu clinics. 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 separated by VA, SVH Option 2, BOP, IHS, and FHCC facilities to the Contracting Officer 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 (Excel Spreadsheet) shall include at a minimum: 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 and attached excel spreadsheet for VA Facility Station Numbers). This report shall be sent to the Contracting Officer, at the following e-mail address: Bonita.Smith@va.gov

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 within 3 business days after award. Orders may be accomplished through on-line ordering, e-mail, 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 (see attached excel spreadsheet for VA Facility Station Numbers). 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 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, facsimile or on-line confirmation within three business days prior to scheduled delivery to allow individual facilities to coordinate receipt of product. No delivery shall be made prior to 8:00am and no later than 2:00pm. No deliveries shall be made on weekends or Federal Holidays. Packaging on deliveries shall clearly indicate “refrigerated product”.

4. 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 GSI or HIBCC 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 (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 clause 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 should 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.

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 Management Association (HDMA) guidelines shall be followed.

5. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) Number unique to the manufacturer (e.g., 00012-3456-78) for each line item proposed, in the space provided following each item in block 20 of the SF1449, “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.

6. NEW DRUG APPLICATION

By signing this solicitation, the offeror certifies that it has 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 a Biologic License approval, as appropriate for the items offered in response to the solicitation. Offeror will obtain any FDA required vaccine batch approvals prior to making any deliveries under the resultant contract.

7. INCORPORATION OF DOCUMENTS

The following documents are hereby incorporated by reference and made a part of this solicitation. The designation "USP" and "NF" shall be considered interchangeable when monographs for ingredients or preparations are transferred from one official compendium to the other. For ingredients or preparations which no longer appear in the latest revision of the USP or NF, the previous volume shall apply. Ingredients or preparations for which monographs appear for the first time in the Official Compendia shall comply with the applicable monographs unless the word "modified" appears as part of the item name. The requirements that an item or ingredient comply with test standards and requirements of the USP or the NF does not delete any other applicable portions of the compendia, such as, but not limited to, General Notices. Thus, for USP/NF items, alternative test methods are permitted.

AMERICAN CHEMICAL SOCIETY (ACS), Reagent Chemicals, American Chemical Society Specifications. (Copies are available from Applies Publications, American Chemical Society, Washington, DC 20036.

U. S. DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, FOOD AND DRUG ADMINISTRATION (FDA). Federal Food, Drug, and Cosmetic Act and Regulations promulgated thereunder. (Copies are available from Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20204).

U. S. PHARMACOPOEIAL CONVENTION, INC. (USP/NF). Pharmacopoeia of the United States. (Copies are available from Mack Publishing Company, Easton, PA 18042).

8. COST RECOVERY FEE and QUARTERLY SALES REPORTS.

(1) Quarterly Sales Reports. In addition to the reports listed in paragraph 3, Reporting Requirements, the Contractor shall report all contract sales under this contract and submit collected Cost Recovery Fees as follows:

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 under the awarded contract. 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, which includes the Federal Excise Tax, shall be collected from all contract users. The 0.5 % Cost Recovery Fee and the Federal Excise Tax shall be imbedded in the awarded contract prices, and offers submitted in response to this solicitation shall include the Cost Recovery Fee and the Federal Excise Tax 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 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.

(3) The sales report signed by an authorized representative of the contractor shall be sent by mail or email to the contracting officer. Emailed transmissions may be sent to Bonita.Smith@va.gov.

Mailed reports shall be sent to the address listed below.

Department of Veterans Affairs National Acquisition Center (36B6B3) P.O. Box 76 First Avenue, 1 Block North of Cermak, Bldg. 37 Hines, IL 60141

(4) In addition to the submission of quarterly sales reports due to the contracting officer within 60 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 facsimile, to the attention of C.R. Agent Cashier, fax: (708) 786-7525.

Cost Recovery Fee. The 0.5 % Cost Recovery Fee amount collected and due shall be paid either electronically or by check, and shall be addressed to the “Department of Veterans Affairs”. When the Contractor has multiple national contracts, the fee may be consolidated into one check. Consolidated payments for multiple contracts shall identify each contract number included, dollar amount remitted for each contract number, and reporting quarter.

To ensure that the payment is credited properly, the contractor shall identify the check or electronic transmission as a “Cost Recovery Fee” and include a copy of the applicable Sales Report. The Cost Recovery Fee payment is due to the Fiscal Division at the same time the sales report is due to the contracting officer, i.e., within 60 calendar days following the completion of each reporting quarter or completion of the contract.

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.

Cost recovery fee payments made electronically shall include the following information:

Contract Number(s): (Contractor shall insert the contract number, which will be assigned by the VA contracting officer at time of award.)

Cost recovery fee payments made in check form shall be made to the attention of “Department of Veterans Affairs” and mailed to the following address:

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.

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.

9. 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 influenza vaccine was issued pursuant to the above Public Law and shall apply to the (c.o. to fill in current dates, e.g. 2011-2012) 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 NLT 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.

NOTE: VA will not require distributors of influenza vaccine who do not have an exclusive distribution agreement with a vaccine manufacturer to execute a MA and PPA, if the offered vaccine is listed on a manufacturer's PPA and has reported (C.O. to fill in correct year) Provisional FCP(s). All offered vaccines must be compliant with Public Law 102-585, Section 603, as explained in the March 31, 2004 Dear Manufacturer Letter. The Government will pay no more than the currently required FCP upon delivery of any vaccine product under this contract

10. DUTY TO WARN-INFLUENZA VACCINE

(a) The VA represents and agrees that it will (1) take all appropriate steps to assure that all vaccine administered to various locations within the 50 states, District of Columbia, Puerto Rico, Virgin Islands, Guam, American Samoa, the Trust Territory of the Pacific Islands, and the Northern Mariana Islands, pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician, or (2) take all appropriate steps to provide to such patient (or to the patient's parent or guardian) meaningful warning relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent, or guardian.

(b) If any claim or action is asserted against Contractor arising in whole or in part from an alleged failure by the Government to carry out its responsibilities under paragraph (a) above, Contractor shall promptly notify the Contracting Officer and provide copies of all pertinent documents served upon or received by Contractor. The Government shall have the option to participate in the defense of that portion of such claim or action which arises from the alleged failure of the Government to carry out its responsibilities under paragraph (a) above.

11. PAYMENT BY GOVERVERNMENT-WIDE COMMERCIAL PURCHASE CARD

(a) Definitions. "Government-wide commercial purchase card" means a uniquely numbered credit card issued by a contractor under GSA's Government-wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases.

"Oral order" means an order placed orally either in person or by telephone, which is paid for by Government-wide commercial purchase card.

(b) At the option of the Government and if agreeable to the Contractor, payments of $250,000 or less for oral or written delivery orders may be made using the Government-wide commercial purchase card.

(c) The Contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been shipped or services performed. Unless the cardholder requests correction or replacement of a defective or faulty item in accordance with other contract requirements, the Contractor shall immediately credit a cardholder's account for items returned as defective or faulty.

12. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

a. The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) 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 cGMP status on record with the FDA for the facilities identified by the offeror in Paragraph h 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 cGMP status 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 a FDA facility inspection that occurred more than two years prior to submission of the offer.

b. 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 is informed in a FDA “warning letter” that it fails to meet FDA current Good Manufacturing Practices (cGMPs) (21 CFR Part 210 and 211), and/or a facility’s unacceptable FDA cGMP status is communicated to the VANAC, the Contracting Officer will apply the procedures outlined in Paragraph d of this clause.

c. Any Contract product manufactured during the period covered by the contractor or its supply source’s unacceptable cGMP status shall not be shipped without written release from the Food and Drug administration (FDA), and material which has been received…