36E79721R0049.docx

36E79721R0049

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

36E79721R0049 10-15-2021 Andrew Cazares andrew.cazares@va.gov (719)235-8579 02:30pm 11-02-2021 Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 325412 1250 Employees N/A N/A X VA & DOD Pharmaceutical Prime Vendors Refer to Attachments A & B, located in Section D.

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141

VA & DOD Pharmaceutical Prime Vendors Refer to Attachments A & B, located in Section D.

See CONTINUATION Page Ramipril Capsules One award will be made in the aggregate for line items:

1, 2, 3, 4, 5, 6 and 7 To be considered for award, offerors must submit a price for the base year and all four one-year options for all line items.

Prices offered shall not exceed two decimal places.

Offered prices must include the Cost Recovery Fee of 0.5%, as outlined in Scope of Contract. Offerors must list an 11 digit NDC number for each offered drug that is unique to the Offeror's company as outlined in scope of contract. If the offeror is a distributor, the NDC number must be unique to the distributor.

See CONTINUATION Page X X 1 scan 19.

Item No.

20.

Schedule of Supplies/Services

21. Quantity 22.

Unit 23.

Unit Price 24.

Amount

To be considered for award, offerors must submit a price for line items: 1, 2, 3, 4, 5, 6 and 7 for the base year and all four option years. One award will be made in the aggregate for line items: 1, 2, 3, 4, 5, 6 and 7 for the base years and all four options. Offered prices shall not exceed two decimal places.

NDC #:_________________

ANDA #:__________________

NDC #:__________________

ANDA #:__________________

NDC #:__________________

ANDA #:__________________

NDC #:_________________

ANDA #:__________________

NDC #:_________________

ANDA #:__________________

NDC #:_________________

ANDA #:__________________

NDC #:_________________

ANDA #:__________________

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

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

Proposals will be accepted in Microsoft Word or PDF form via e-mail at Andrew.cazares@va.gov with a scanned (pdf) copy of the signed SF1449. Please note that faxed proposals are not acceptable and will be rejected. Reference FAR 52.212-1(f) regarding timeliness of submission of offers.

If the offeror is not the manufacturer of the offered items, the offeror shall submit a Letter of Commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity that measures, mixes, weighs, and compounds the active and inactive ingredients into a capsule or tablet. An acceptable Letter of Commitment is required from all distributor-offerors to be eligible for award. The offeror must maintain the same manufacturer (NDA/ANDA/BLA) for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award. If the offeror is not a manufacturer, to be eligible for award, offerors must submit a Letter of Commitment that meets all requirements stated in the Addendum to FAR 52.212-1 INSTRUCTIONS TO OFFERORS.

One award will be made in the aggregate for all line items for the base year, including all four option years. To be considered for award, offerors must propose a price for line item 1, 2, 3, 4, 5, 6 and 7 for the base year and each option year. Proposals that fail to include a price for the base year and each of the four option years for line item 1, 2, 3, 4, 5, 6 and 7 may be rejected and receive no further consideration.

(Refer to Schedule of Supplies for package size details and estimates)

Offered prices shall include a 0.50% Cost Recovery Fee (See Scope of Contract, paragraph 12).

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

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

The System for Award Management (SAM) is the Official U.S. Government system that consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. Contractors should go to www.sam.gov to find their information. Training tools are available on the SAM website for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually.

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

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

SCOPE OF CONTRACT

1. INTRODUCTION

1.1 Background. All Ordering Activities under the VA and all Ordering Activities under the Department of Defense (DOD) acquire their pharmaceutical requirements through their respective Pharmaceutical Prime Vendor Programs (PPV), hereafter referred to as the VA PPV Program and DOD PPV Program or jointly as PPV Programs. The PPV Programs are separate contracts which establish the fees for the distribution of pharmaceutical products that are distributed through the PPV Programs on Federal Government (i.e., Federal Supply Schedules, National Standardization) contracts. A contract resulting from this solicitation establishes the VA National Contract prices for the products listed in the schedule of supplies that will be distributed through the PPV Programs. Section 2.1, “Government Participants” lists the PPV Program participants that will be authorized users of the contract resulting from this solicitation. The contractor shall follow 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 a supply source that will provide the drugs listed in the schedule for purchase through the PPV Programs. The total annual estimated usage for VA, Federal Health Care Center (FHCC), State Veterans Homes - Option 2 (SVH), DOD, Indian Health Service (IHS), and Bureau of Prisons (BOP) appears on the Schedule of Supplies section of this Solicitation. The objective of such a contract is to ensure availability and consistency of product for nationwide usage and to obtain volume-based, committed-use pricing.

1.3 Government Purchase Compliance. VA, FHCC, SVH (Option 2), DOD, IHS, and BOP will purchase their requirements for the strengths of the drugs listed in the schedule through the PPV Programs except when: (1) the contracted items are unavailable to meet the needs of the Government, or (2) an alternate is requested by the prescribing healthcare provider, or (3) additionally, IHS will not participate if the awardee does not have a Centers of Medicare or Medicaid (CMS) reimbursable product(s). In the event that exception 1, 2, or 3 applies, these instances will be considered exceptions to section C.2 – 52.216-21, Requirements. VA’s PPV contract has ordering lock-out procedures in place to support VA contract compliance and to prevent purchases of non-contract products. Participants of the VA PPV Program include VA, FHCC, SVH (Option 2), IHS, and BOP. DOD manages compliance through individual facility tracking reports.

1.4 Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF1449 and notifies the offer (contractor) of award. The first 60 days of the contract period (or a shorter time period, if mutually agreed between the contractor and Government) will be an implementation period when the PPVs begin placing orders with the contractor for delivery to multiple PPV distribution centers. Orders placed with the PPVs by Government participants will begin shipping under this contract upon the expiration of the 60-day implementation period. There are approximately 31 VA PPV Distribution Centers and approximately 25 DOD PPV Centers located nationwide. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements with the PPVs have been executed with sufficient time to permit the PPVs to begin timely distribution of Government orders by the expiration of the contract implementation period. The current PPVs are listed as attachments “A” and “B” of this solicitation. The current PPVs may change and the contractor will be notified of any changes in PPV contractors during the term of the contract resulting from this solicitation. Payment terms, time and place of delivery to PPV distribution centers and other business-to-business agreement terms shall be agreed upon between the PPV contractors and the contractor awarded a contract from this solicitation. The Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPVs by 15 days before commencement of the period of performance. Failure or refusal to reach agreement with the PPVs shall constitute sufficient cause for terminating the contract under FAR Part 52.212-4(m), Contract Terms and Conditions-Commercial Items, Termination for Cause.

1.5 Contract Duration. The contract(s) resulting hereunder will be in effect for one (1) year with four (4) one-year pre-priced option periods that may be exercised unilaterally by the Government in accordance with FAR 17.207 and FAR 52.217-9.

1.6 Special Contract Considerations. As discussed in Section 1.2, this solicitation establishes a supply source to provide the drugs listed in the schedule for purchase through the PPV programs. Additionally, as outlined in Section 1.4, the awarded offeror (contractor) under this solicitation must reach a business-to-business agreement with the respective PPV programs. Because the PPV programs distribute the supplies sourced from this solicitation, special contract considerations apply.

Under this resulting contract, the contractor will be receiving payments from the PPV programs instead of directly from the Government. Due to this unique payment structure, contractors are not permitted to assign their rights to receive payment under this contract. Additionally, disputes arising between a contractor and any authorized Government Prime Vendor(s) do not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the contractor to the Government ordering facilities. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV programs.

2. EXTENT OF OBLIGATION

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

All Department of Veterans Affairs (VA) facilities All Ordering Activities under the Department of Defense (DOD) Pharmaceutical Prime Vendor Program All Indian Health Service (IHS) facilities All Bureau of Prisons (BOP) facilities Captain James A. Lovell Federal Health Care Center (FHCC) All Option 2 State Veteran Homes (See paragraph 2.2 State Veteran Homes)

A database of all facilities authorized to use the VA PPV Program may be downloaded from the National Acquisition Center’s web site at http://www.va.gov/oal/business/nc/ppv.asp.

2.2 State Veteran Homes (SVH’s). There are numerous SVHs that have entered into sharing agreements with VA Medical Centers (VAMCs). The SVHs with sharing agreements that participate in the VA PPV Program are identified as being one of two types: Option 1 or Option 2.

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

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

2.3 Consolidated Mail Outpatient Pharmacies (CMOPs) (VA ONLY) and Tricare Mail Order Pharmacies (TMOPs) (DoD ONLY). Many drugs are prescribed and mailed directly to patients’ homes in three-month or 90-day supply and VA CMOPs/DoD TMOPs may place an initial order with the VA PPV/DoD PPV contractor for up to 30% of the estimated VA/DoD annual contract quantities immediately upon the contract effective date. An initial order of up to 30% of the estimated VA/DoD annual contract quantities may be placed by the VA PPV/DoD PPV contractor with the contractor awarded a contract under this solicitation to fulfill the CMOP and/or TMOP 30% initial order requirements.

2.4 Estimated Quantities. The quantities in the schedule reflect the combined usage of all VA (inclusive of FHCC and SVH), DOD, IHS, and BOP activities currently participating in the PPV Programs. These estimated annual requirements do not include those of any other Government agency, including those currently participating in the VA PPV Program (e.g. Immigration and Customs Enforcement, Option 1 State Veteran’s Homes). The estimated usage cited in the Schedule is the Government’s total estimated usage for the strengths listed. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.

3. PRODUCT REGISTRATION

Product information pertaining to all items offered under this solicitation, including the offeror’s unique National Drug Code(s) (NDC), must be submitted to First Data Bank, Medispan and Multum prior to the effective date of contract performance. A New Product Submission Form can be obtained by contacting First Data Bank at (800) 633-3453, extension 566, or information can be obtained l at http://www.fdbhealth.com/solutions/manufacturer-relations/. Medispan information can be obtained at http://www.medispan.com/drug-information-products/. A New Product Submission Form can be obtained by emailing MultumSupport@Cerner.com. All new products and product updates should be sent to Cerner Multum at mfgproducts@cerner.com.

4. NATIONAL CONTRACT ITEM BACKORDERS

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

For purposes of this contract, a backorder occurs when the PPVs issue an order with the contractor, and the complete order quantity is not delivered to the PPVs within 15 days after receipt of order. This includes initial CMOP orders. If a national contract item is backordered by the PPVs, the VA National Acquisition Center (VANAC) contracting officer will investigate the backorder to determine if the national contract contractor bears responsibility for the backorder. The awarded contractor shall inform the VANAC contracting officer within four calendar days after a backorder occurs. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backorder will be shipped, and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate a national contract backorder situation. If the contracting officer determines that the contractor bears responsibility for the backorder, and the contractor is not able to provide a solution that is acceptable to the Government, (i.e., acceptable solution to the backorder, in lieu of Termination for Cause), the parties agree that the Government may buy against the contractor by acquiring the same or similar items from another source and billing the contractor for any excess procurement costs. In other words, if the Government must purchase product from another vendor because of a national contract backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the contract price within 30 calendar days after receipt of notification. The contractor shall also provide written verification to the Contracting Officer when credits or reimbursement have been made within 30 calendar days from date of reimbursement. After a backorder incident occurs for which the Contractor is responsible, the Government’s decision to enter into a buy-against agreement described above will not deprive the Government of its right under FAR 52.212-4(m) to terminate the contract for a breach of the buy-against agreement, for a subsequent contractor-caused backorder, or for any other sufficient cause.

5. PACKAGING REQUIREMENTS

Offerors must state the exact name of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number for all items offered; the NDC number must be specific to the offering company and to the drug being supplied. All bottles of 400 tablets/capsules or less must have a safety-cap capable of having the outer part of the cap deshelled and/or a convertible cap to produce a non-safety cap child resistant closure. All tablets/capsules must be compatible with automated dispensing units (Baxter ATC Canisters, Opitfill, etc.). Glass bottles are not acceptable. Items are identified in the Schedule of Supplies and in Attachment C.

6. BAR CODING

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

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

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

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

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

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

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

7. THERAPEUTIC EQUIVALENCE

To be considered the offered products must have received a therapeutic equivalence rating of “A” by the U.S. Food and Drug Administration (FDA) in accordance with the Food, Drug and Cosmetic Act. If no therapeutic equivalence rating is assigned, award will be made to an innovator’s product.

8. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) Number unique to the offeror (e.g., 00012-3456-78) for each product 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 offeror.

Offerors must provide their own labeler code, to be used in the National Drug Code (NDC) number for the offered items. If an offerors is a dealer/distributor and does not have a labeler code, it must apply and be approved with the FDA for its own labeler code prior to making an offer under this solicitation. Offers that fail to provide the information required by this paragraph by the solicitation closing date may be rejected and receive no further consideration.

9. DRUG APPLICATION

By signing this solicitation, the offeror certifies that it has on file (if any of the following are required by the 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.

10. RECALLS

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

Chief, Pharmaceutical Division (003B6C3) VA National Acquisition Center National Contract Service 1st Ave., 1 Block North of Cermak Rd., Bldg. 37 P.O. Box 76, Hines, IL 60141 Fax Number (708) 786-5256

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

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

All Government Prime Vendors that were sent shipments of the affected product(s).

11. COVERED DRUGS

Should a covered drug be proposed and awarded as a result of this solicitation, the awarded prices shall meet the requirements of Public Law 102-585, Section 603, the Veterans Healthcare Act of 1992, (38 U.S.C. § 8126) and shall apply to all Government participants listed in Section 2.1 of the Scope of Contract, regardless of whether the participant is covered under the law. Therefore, prices for the base year and all option years shall not exceed the annually established Federal Ceiling Price (FCP), plus the 0.5% Cost Recovery Fee (CRF).

Attention is directed to the fact that although 38 U.S.C § 8126 applies to covered drugs, competitively negotiated and awarded prices for the base year and any option years exercised by the government will govern unless the annually established FCP results in a price lower than competitively awarded contract prices. In this instance, the contract will be modified to reflect the lower annually established FCP, plus the 0.5% CRF.

Both parties understand the VA National Contract Service will obtain FCPs from the VA Pharmacy Benefits Management (PBM). The parties agree the FCP will be calculated pursuant to the requirements of 38 U.S.C 8126, which includes the contractor’s Master Agreement, and Pharmaceutical Pricing Agreement, and any relevant VA Dear Manufacturer Letters.

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

MASTER AGREEMENTS AND PHARMACEUTICAL PRICING AGREEMENTS

In compliance with 38 U.S.C. § 8126, 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 executed MA and PPA on file with VA's National Acquisition Center.

12. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

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

(A) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). A Cost Recovery Fee equivalent to 0.5 % of the current contract price shall be collected from all contract users. The 0.5 % Cost Recovery Fee shall be imbedded in the awarded contract prices, and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line item price offered. The reported contract sales shall include the Cost Recovery Fee and each quarterly report shall show the total cost recovery fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice.

(B) Contract sales reports are due to the 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.

(C) The sales report signed by an authorized representative of the contractor shall be emailed to the Contracting Officer.

(D) 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 email to: AMMHINBOCFISCAL@VA.GOV.

12.2 The 0.5% Cost Recovery Fee amount shall be paid electronically via ACH (Automated Clearing House). ACH credit instructions will be provided to the contractor upon contract award. When the Contractor has multiple national contracts, the fee may be consolidated into one electronic payment. When the electronic payment is made, the contractor shall submit an email to AMMHINBOCFISCAL@VA.GOV to identify the contract number (or numbers, if the payment covered multiple contracts) included, dollar amount remitted for each contract number, and reporting quarter. The Cost Recovery Fee payment is due to the 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.

12.3 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.

12.4 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 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 52.212-4(i)(6)). 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 paragraph, all other rights and remedies permitted by Federal law and statutes.

13. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

13.1 The FDA is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (GMP) standards for human drugs, pharmaceutical products, biologicals, medical devices, chemical products, medical cylinder oxygen, reagents, diagnostics, test kits and sets included in this solicitation. Only offers from companies that have an acceptable GMP status on record with the FDA for the facilities identified by the offeror in Paragraph 13.7 below will be considered for award. The FDA will evaluate a prospective offeror for VA procurements only if the offeror has had a qualifying GMP inspection within the previous two years. Before a contract can be awarded, any successful offeror’s manufacturing facilities shall have a current acceptable GMP status with the 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 within two years prior to submission of the offer.

13.2 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 (GMPs) (21 CFR Part 210 and 211), and/or a facility’s unacceptable FDA GMP status is communicated to the VANAC, the Contracting Officer will apply the procedures outlined in Paragraph 13.3 below.

13.3 The VANAC Contracting officer will review the contractor’s (or its source’s) unacceptable GMP status with appropriate VHA clinical staff and will either: 1) instruct the contractor to stop the shipment of products listed on this contract that were manufactured and/or packaged in a facility with unacceptable GMP status, or 2) authorize the contractor to continue to supply such contract products for 90 days from the date when unacceptable GMP status was communicated to VANAC, provided that the products have not been subjected to a consumer-level recall. An additional 90-day extension may be authorized at the discretion of the VANAC Contracting Officer. Contractors are cautioned that products that were manufactured and /or packaged in a facility with unacceptable GMP status and then shipped without written authorization from the VANAC Contracting Officer shall be returned to the contractor at the contractor’s risk and expense. The contractor shall have corrected all significant GMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to unacceptable status by the end of the 90-day authorization period and any extensions of such period granted by the VANAC Contracting Officer. Additionally, the contractor is responsible for keeping the VANAC Contracting Officer informed of all corrections made and shall provide the VANAC Contracting Officer with: 1) written documentation of the correction plan, 2) Notification from FDA of acceptance of plan, and 3) a copy of any reinspection requests and subsequent reinspection reports, when they are available. If FDA’s evaluation of contractor’s (or its source’s) compliance efforts and/or re-inspection of the non-compliant facility does not result in an acceptable rating by the FDA within 90 days from the date when unacceptable GMP status was communicated to VANAC, or by the end of a VANAC Contracting Officer’s authorization period (whichever is the greater period of time), the contract may be terminated for cause in accordance with FAR Clause 52.212-4(m). The contractor’s (or its source’s) failure to correct the GMP deficiencies in a timely manner shall not constitute or give rise to any “excusable delays” pursuant to FAR Clause 52.212-4(f). (Nothing in this paragraph shall be read as limiting the recognized grounds upon which a Contracting Officer may terminate this contract or delete products pursuant to the applicable paragraphs contained in the contract.)

13.4 The contractor shall use only the FDA-inspected manufacturing facilities provided in Paragraph 13.7, below, for the duration of the contract, unless substitution of manufacturing facilities is approved by the VANAC Contracting Officer. In case of any manufacturing facility relocation or substitution of manufacturing facilities, the contractor shall notify the VANAC Contracting Officer of the pending change, and the contractor shall request approval from the VANAC Contracting Officer to supply the contracted products from the new location. If the change is approved by the VANAC Contracting Officer after an inquiry to the FDA for GMP status of the new location, approval will be provided by means of a formal contract modification.

13.5 If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be substantially in compliance with applicable FDA GMP standards prior to contract award.

13.6 Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered. “Manufacturer” is defined as the entity that measures, mixes, weighs, and compounds the active and inactive ingredients into a capsule or tablet.

13.7 The offeror is required to indicate below the complete name and address(es) of the manufacturer. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

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

The offeror must maintain the same manufacturer (NDA/ANDA/BLA) for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award.

THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address) (Post Office Address Not Acceptable)

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

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

PHARMACEUTICALS – PARENTERALS

Solicitation Item # & Product Name

Location and Owner of Facility where ingredients are measured, weighed, mixed and compounded (Facility Owner Name, Address, City, County, State and Zip Code)

Point of Contact including Phone #

PHARMACEUTICALS – PARENTERALS, STERILIZATION

Solicitation Item # & Product Name

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

Point of Contact Including Phone #

TABLETS, CAPSULES AND PILLS

Solicitation Item # & Product Name

Location and Owner of Facility where Ingredients are measured, weighed, mixed and compounded (Facility Owner Name, Address, City, County, State and Zip Code)

Point of Contact including Phone #

OTHER PHARMACEUTICAL PRODUCTS

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

Solicitation Item # & Product Name

Location and Owner of Facility where Ingredients are measured, weighed, mixed and compounded (Facility Owner Name, Address, City, County, State and Zip Code

Point of Contact including Phone #

PACKAGING

Solicitation Item # & Product Name

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

Point of Contact including Phone #

PACKING

Solicitation Item # & Product Name

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

Point of Contact including Phone #

14. 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).

36E79721R0049

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.