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6505--FEBUXOSTAT Federal contract opportunity
Solicitation number
36C77021Q0153
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 15

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36C77021Q0153

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

NCO 15 Contracting Ofc - CMOP 770-21-2-801-0557 36C77021Q0153 02-22-2021 Ralph Crum 913-684-0138 03-05-2021

4PM

CST

36C770 Department of Veterans Affairs NCO 15 Contracting Ofc - CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5012 X 325412 1250 Employees N/A X 36C770

DELIVERY ADDRESSES TO BE SPECIFIED

ON INDIVIDUAL DELIVERY ORDERS

(SEE ATTACHED PRICE QUOTE SPREADHSHEET

Q0153 FOR LIST OF DELIVERY LOCATIONS).

36C770 Department of Veterans Affairs NCO 15 Contracting Ofc - CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5012

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 See CONTINUATION Page Description of Requirement:

Indefinite Delivery Indefinite Quantity (IDIQ) Single Award Contract for Febuxstat as specified in B.2 Statement of Requirements.

Please submit quotes and subcontracting plan (if large business) to Ralph Crum (Ralph.Crum@VA.GOV) no later than due date and time specified in Block 8 of Standard Form (SF) 1449 of solicitation.

This acquistion is subject to the Drug Supply Chain Security Act as specified in Section B.2 (Statement of Requirements).

See CONTINUATION Page 770-3610160-801-822400-2631 0100224G3 X X X One Ralph Crum Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 F0434 & F0435 Pharmaceutical Statement of Requirements4
B.3 PRICE/COST SCHEDULE12
ITEM INFORMATION12
SECTION C - CONTRACT CLAUSES14
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)14
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)20
C.3 52.216-18 ORDERING (AUG 2020)20
C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)21
C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)21
C.6 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JUN 2020)22
C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)32
C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)33
C.9 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)34
C.10 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)35
C.11 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)35
C.12 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)36
C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)36
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS45
SECTION E - SOLICITATION PROVISIONS46
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)46
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)50
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)50
E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)53
E.5 52.216-1 TYPE OF CONTRACT (APR 1984)54
E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)54
E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)55
E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2020)56

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C770 Department of Veterans Affairs NCO 15 Contracting Ofc - CMOP 3450 S. 4th St. Trafficway

Leavenworth KS 66048-5012

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

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Upon acceptance by the Government.

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

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

36C77021Q0153

Page 1 of Page 1 of B.2 F0434 & F0435 Pharmaceutical Statement of Requirements

VA FORM 2237 #___770-21-2-801-0557______

I. PRODUCT SERVICE CODE/NAICS INFORMATION

1. Product Service Code: 6505 (Drugs and Biologicals)

2. NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing)

II. DESCRIPTION OF REQUIREMENT

1. Febuxostat, for a single award Indefinite Delivery, Indefinite Quantity (IDIQ) for Consolidated Mail Outpatient Pharmacies (CMOP) Nationwide.

III. ROLES AND RESPONSIBILITIES

1. Contracting Officer Representative (COR)

2. A COR will be designated on authority of the Contracting Officer (CO) to monitor all technical aspects and assist in administering the IDIQ and related delivery orders. The types of actions within the purview of the COR’s authority are to assure that the vendor perform the technical requirements of the contract; to perform or cause to be performed inspections necessary in connection with performance of the contract; to maintain both written and oral communications with the vendor concerning the aspects of the contract within his/her purview; to issue written interpretations of technical requirements of Government specifications; and to monitor the performance of the vendor under the contract and notify the vendor and CO of any deficiencies observed. A memorandum of delegation will be issued to the COR with a copy supplied to the vendor, stating the responsibilities and limitations of the COR.

3. At no time may the scope, work, price, delivery dates, or other mutually agreed upon terms or provisions of the contract be changed without being executed in writing by the CO authorizing such changes.

4. The COR may be changed at any time by the Government without prior notice to the vendor, but notification of the change, including the name and address of the successor COR, will be promptly provided to the vendor by the CO in writing.

Contracting Officer (CO) Name: Ralph Crum Phone: 913-684-0138 E-mail: Raph.Crum@va.gov

5. All contract administration will be effected by the CO. Communications pertaining to contract administration matters will be addressed to the Contacting Officer. No changes in or deviation from the scope of work shall be effected without a Standard Form 30 (Modification of Contract) executed by the CO authorizing such changes.

6. The CO is the only person authorized to make or approve any changes in any of the requirements of the contract and related delivery orders; and notwithstanding any provisions contained elsewhere, the said authority remains solely with the CO. In the event the vendor makes any changes at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

IV. PERIOD OF PERFORMANCE

1. This is a single award IDIQ contract with delivery orders.

2. Period of performance (one-year base period) for an IDIQ contract is as follows:

Period
Begins
Ends
Base Period
04-01-2021
03-31-2022

3. Per FAR clause 52.212-4 (l), the Government reserves the right to terminate this IDIQ contract, or any part hereof, for its sole convenience.

V. ORDERING PROCEDURES

1. The IDIQ contract does not obligate any funding. Funding will be obligated via issuance of delivery orders against this IDIQ contract. Vendor is expected to be able to perform all aspects of the work specified in B.2 (Statement of Requirements).

2. All delivery orders issued by the Government will specify at a minimum:

· Period of performance of delivery orders

· CMOP locations to be serviced by delivery orders

· Quantities/descriptions of items for delivery orders

· National Drug Code (NDC) accepted by CMOP, as well as any acceptable NDC proposed by the vendor

3. Delivery orders may be issued by any warranted Contracting Officer (CO) within Network Contracting Office (NCO) 15, CMOP Division or Ordering Officer, as designated by the CO.

4. “Ordering officers (OOs) will be authorized to place orders against this contract. The Contracting Officer (CO)will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum upon issuance of the contract. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.”

VI. DELIVERY TERMS

1. The Government reserves the right to cancel any quantities NOT delivered on or before the required date as specified in solicitation and purchase order.

2. All products supplied under this contract must be shippable by the United States Postal Service (USPS) unless specifically identified otherwise by the vendor and accepted by the Contracting Officer. Failure of the vendor to notify the Contracting Officer of the non-shippable status of a product (usually due to flammability) will result in cancellation or return of the product at the offeror’s expense. “Shippable” means the product must able to be shipped by the USPS when the Consolidated Mail Outpatient Pharmacy (CMOP) issues it to a patient. It DOES NOT mean that the product supplier must ship the product to the CMOP via USPS. The most cost-effective method of shipping should be used for initial delivery to the CMOP.

3. For reconciliation purposes, all shipments must reference the original VA obligation number (i.e., 770A712345) even if purchased product is from another partnered company. This obligation number is referenced by CMOP receiving facility to verify receipt of items, and by the VA Fiscal Service Center to pay invoices submitted by vendor.

4. Deliveries are to be coordinated by shipper with receiving CMOP facilities) to ensure deliveries occur within operational hours.

5. Delivery may be required to multiple delivery points as specified on solicitation and purchase order.

6. The contractor is to email tracking information to points of contact listed on Delivery Schedule in Section B of the solicitation and purchase order upon shipment of products. cynthia.hanson@va.gov.

VII. ADDITIONAL TERMS PROPOSED BY CONTRACTOR:

1. Any alternate National Drug Codes (NDCs) that vendors wish to quote shall be listed on the attached quote spreadsheet (where applicable).

2. Acceptance prior to purchase order of any vendor quoted NDC or Universal Product Code (UPC) shall be contingent on CMOP approval.

3. If a line item indicates more than one NDC/UPC, vendor SHALL specify which NDC/UPC is used when quoting. If offering an alternate, vendor MUST indicate proposed alternate on the attached quote spreadsheet in the column titled “ALTERNATE NDC (PKG SZ)” and indicate bottle size in parentheses (i.e., 500 CT). ALL OFFERS SHALL BE SUBMITTED ON THE ATTACHED QUOTE SPREADSHEET.

4. If the pre-approved alternate NDC is provided by the vendor, and if the unit size is different from the original unit requested, then the vendor must also adjust the final quantity accordingly. For example: Solicitation is for 100 quantities of 1000 CT bottles. Vendor submits quote for 500 CT. Quantity would need to be changed to 200.

5. The quoted alternate terms or conditions shall be reviewed by the Contracting Officer and, if accepted, shall be included in the resulting purchase order. Alternate terms and conditions quoted elsewhere will not be considered and will not be included in any resultant purchase order.

VIII. BAR CODING

1. All pharmaceutical products provided under the resulting purchase order 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.

2. The bar code may be any linear bar code symbology, such as GS1-128 (formerly EAN.UCC), GS1 Data Bar (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)).

3. 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 authorized ordering activity under this contract.

4. 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 overwrap, the overwrap must contain the bar code.

5. 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 must not be printed across the perforations of a blister pack.

6. 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.

7. 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.

IX. THERAPEUTIC EQUIVALENCE

Only products that have received, under the Federal Food, Drug and Cosmetic Act (FFDCA), a therapeutic equivalence code of “A” by the Food and Drug Administration (FDA) will be considered, unless all drugs in the family group are “B” rated. In that case, no purchase order will be made other than to the innovator unless the non-innovator offeror submits acceptable data demonstrating bioequivalence.

X. RECALLS -- THIS IS FOR FSS ONLY

1. If a drug recall is initiated for any drug provided under the resulting purchase order, regardless of whether it is a voluntary recall by the manufacturer or a recall required by FDA, or, if FDA withdraws their approval to manufacture any drug that is included on this purchase order, the following action shall immediately be taken by the vendor:

2. Forward two (2) copies of the recall notification along with any pertinent information to:

1) Chief, Pharmaceutical Federal Supply Schedule Service (003A4B) VA National Acquisition Center P.O Box 76 Hines, IL 60141 Fax number: (708) 786-4974

2) 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 Fax number: (708) 786-7894

3) 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) 930-5865

4)All authorized ordering activities that were sent shipments of the affected product(s).
5)All FSS ordering activities that were sent shipments of the affected product(s).

XI. RECALLS -- THIS IS FOR OPEN MARKET ONLY

1. If a drug recall is initiated for any drug provided under the resultant purchase order, regardless of whether it is a voluntary recall by the manufacturer or a recall required by FDA, or, if FDA withdraws their approval to manufacture any drug that is included on the resultant purchase order, the following action shall immediately be taken by the vendor:

2. Forward two (2) copies of the recall notification along with any pertinent information to:

1) Director, CMOP Acquisitions Veterans Health Administration Network Contracting Office (NCO15) 3450 South 4th Street Leavenworth, KS 66048-5012 Fax Number: (913) 684-0179

2) 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 Fax Number: (708) 786-7894

3) 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) 930-5865

4) CMOP address shown in Block 15 of the Standard Form (SF) 1449 of the resultant purchase order.

XII. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) number (e.g., 00012-3456-78) for each product proposed on the attached quote spreadsheet of the solicitation. Quotes that fail to provide the information required by this section by the solicitation closing date shall be rejected and shall receive no further consideration.

XIII. FIRM COMMITMENT OF PRODUCT AVAILABILITY AND PRICE

Just prior to purchase order, usually 24-hours, the Offeror shall be required to provide a firm commitment of availability and price. This commitment may be in the form of an email certifying availability or other document illustrating or showing availability.

XIV. OTHER REQUIREMENTS

1. Any package size ordered below 500 count is considered to be for Unit of Use issue and requires a Safety/Child Proof cap.

2. The expiration dates of the pharmaceutical(s) shall be no less than 12 months from date of delivery.

3. Substitutions of pack sizes must be approved in writing by the Contracting Officer prior to shipment

4. Any change that deviates from the specific item requested must be approved by the Contracting Officer in writing. For example, the replacement of capsules for tablets or suspended action for extended release items will require approval prior to shipment.

5. Partial deliveries of product must be approved in writing by the Contracting Officer prior to shipment

6. Minimal lot numbers of product is required. More than three (3) lot numbers of product must be approved by the Contracting Officer in writing prior to shipment.

7. A minimum bottle size is 100cc with a child safety type cap that does not exceed the diameter of the bottle. It must also have a cylindrical body and minimum of 5.75-inches circumference.

8. It is incumbent upon the vendor to initiate any actions requiring the approval of the Contracting Officer. Failure to obtain Contracting Officer approvals may result in termination of purchase order in accordance with Federal Acquisition Regulation (FAR) clause 52.212-4 (Contract Terms and Conditions – Commercial Items) as specified in solicitation and purchase order.

9. All shipments shall come with a packing slip identifying Vendor name/address, VA Purchase Order Number (i.e., VA770-17-P-1234), VA Obligation Number (i.e., 770A12345), NDC, PRODUCTS, and LINE ITEM NUMBERS from the purchase order document. Documentation shall include Vendor’s point of contact for reporting noted discrepancies, damages, or incorrect product. Invoice price must match purchase order price. Failure to supply this information may cause a delay with payment or rejection of the product if the order information is not readily apparent.

10. All like products shall be packaged and shipped together. Breakable items shall be packaged appropriately with blister pack or bubble wrap. Requirements meeting case pack size will be shipped in the original manufactures packaging. Quantities less than case size may be shipped in repack boxes but must be clearly marked as repacks

11. Vendor shall provide a return authorization and pickup for any damaged products or incorrect products received within one (1) week of request.

For Awarded Vendor(s) Only to Complete

XV. DRUG SUPPLY CHAIN SECURITY ACT COMPLIANCE

THIS APPLIES TO PRESCRIPTION PHARMACEUTICALS PROCUREMENTS ONLY

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm As of January 1, 2015, all suppliers of prescription drug products (i.e., products which have been approved and which may be dispensed only by prescription under section 503(b) of the FDCA), must comply with the provisions of The Drug Supply Chain Security Act (DSCSA), and all trading partners must be authorized as defined by this act..

The documentation must be provided with the product or prior to receipt and documentation must comply with the DSCSA. The documentation can be paper-based or electronic (i.e., Electronic Data Interchange [EDI], Electronic Product Code Information Services [EPCIS] or Abstract Syntax Notation [ASN] file format) to meet the requirements of the DSCSA.

The TH (Transaction History), TI (Transaction Information) And TS (Transaction Statement) may be submitted by e-mail to the following group or groups as appropriate:

☒ VHACMOPProcurement/Logistics760@va.gov (Leavenworth CMOP) ☒ VHACMOPProcurement/Logistics761@va.gov (Chelmsford CMOP) ☒ VHACMOPProcurement/Logistics762@va.gov (Tucson CMOP) ☒ VHACMOPProcurement/Logistics763@va.gov (Dallas CMOP) ☒ VHACMOPProcurement/Logistics764@va.gov (Murfreesboro Elam Farms CMOP) ☒ VHACMOPProcurement/Logistics765@va.gov (Hines CMOP) ☒ VHACMOPProcurement/Logistics766@va.gov (Charleston CMOP) The documentation required is as follows:

Transaction History (TH) A paper or electronic statement shall include the transaction information for each prior transaction for the subject product going back to the manufacturer of the product.

Transaction Information (TI) A paper or electronic document containing:

1. the proprietary or established name or names of the product;

2. the strength and dosage form of the product as stated on the manufacturers label

3. the National Drug Code number of the product;

4. the container size;

5. the number of containers;

6. the lot number of the product;

7. the date of the transaction;

8. the date of the shipment, if more than 24 hours after the date of the transaction;

9. the business name and address of the person from whom ownership is being transferred; and

10. the business name and address of the person to whom ownership is being transferred.

Transaction Statement (TS) A paper or electronic document stating, that the entity transferring ownership in a transaction:

1. is authorized as required under the Drug Supply Chain Security Act;

2. received the product from source that is authorized as required under the Drug Supply Chain Security Act;

3. received transaction information and a transaction statement from the prior owner of the product, as required under section 582;

4. did not knowingly ship a suspect or illegitimate product;

5. had systems and processes in place to comply with verification requirements under Section 582;

6. did not knowingly provide false transaction information; and

7. did not knowingly alter the transaction history.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
40,000.00
BT
__________________
__________________

F0434: FEBUXOSTAT 40MG TAB

ESTIMATED MAXIMUM QUANTITY: 40,000 BT

ORDERS TO BE PLACED AT THE SITE LEVEL BY USING ORDERING OFFICER DELEGATIONS

Contract Period: Base POP Begin: 03-08-2021 POP End: 03-07-2022

20,000.00
BT
__________________
__________________

F0435: FEBUXOSTAT 80MG TAB

ESTIMATED MAXIMUM QUANTITY: 20,000 BT

ORDERS TO BE PLACED AT THE SITE LEVEL BY USING ORDERING OFFICER DELEGATIONS

Contract Period: Base POP Begin: 03-08-2021 POP End: 03-07-2022

GRAND TOTAL
__________________

Statement of Requirements Version 5.01 January 30, 2018

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

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

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

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

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

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

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

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

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

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR Number
Title
Date
52.203-17
CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS
JUN 2020
52.204-4
PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER
MAY 2011
52.204-13
SYSTEM FOR AWARD MANAGEMENT MAINTENANCE
OCT 2018
52.204-18
COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE
AUG 2020
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
DEC 2013
52.242-17
GOVERNMENT DELAY OF WORK
APR 1984
852.212-71
GRAY MARKET ITEMS
APR 2020
852.242-71
ADMINISTRATIVE CONTRACTING OFFICER
OCT 2020

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 04/01/2021 through 03/31/2022.

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

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

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

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

(3) If sent electronically, the Government either—

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

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

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

(End of Clause)

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

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $3,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

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

(1) Any order for a single item in excess of $150,000.00;

(2) Any order for a combination of items in excess of 150,000.00; or

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

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

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

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

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

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

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

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

(End of Clause)

C.6 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JUN 2020)

(a) This clause does not apply to small business concerns.

(b) Definitions. As used in this clause— Alaska Native Corporation (ANC) means any Regional Corporation, Village Corporation, Urban Corporation, or Group Corporation organized under the laws of the State of Alaska in accordance with the Alaska Native Claims Settlement Act, as amended (43 U.S.C. 1601, et seq.) and which is considered a minority and economically disadvantaged concern under the criteria at 43 U.S.C. 1626(e)(1). This definition also includes ANC direct and indirect subsidiary corporations, joint ventures, and partnerships that meet the requirements of 43 U.S.C. 1626(e)(2).

Commercial item means a product or service that satisfies the definition of commercial item in Federal Acquisition Regulation (FAR) 2.101.

Commercial plan means a subcontracting plan (including goals) that covers the offeror's fiscal year and that applies to the entire production of commercial items sold by either the entire company or a portion thereof (e.g., division, plant, or product line).

Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

Indian tribe means any Indian tribe, band, group, pueblo, or community, including native villages and native groups (including corporations organized by Kenai, Juneau, Sitka, and Kodiak) as defined in the Alaska Native Claims Settlement Act (43 U.S.C.A. 1601 et seq.), that is recognized by the Federal Government as eligible for services from the Bureau of Indian Affairs in accordance with 25 U.S.C. 1452(c). This definition also includes Indian-owned economic enterprises that meet the requirements of 25 U.S.C. 1452(e).

Individual subcontracting plan means a subcontracting plan that covers the entire contract period (including option periods), applies to a specific contract, and has goals that are based on the offeror's planned subcontracting in support of the specific contract, except that indirect costs incurred for common or joint purposes may be allocated on a prorated basis to the contract.

Master subcontracting plan means a…

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