36E79722R0024.docx

36E79722R0024 06-15-2022 36E79722R0024

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

6. SOLICITATION ISSUE DATE

5. SOLICITATION NUMBER

4. ORDER NO.

3. AWARD/EFFECTIVE DATE

2. CONTRACT NO.

1. REQUISITION NO.

PAGE 1 OF

2:30pm CT 06-30-2022 708-786-4943 Youlanda Duggar Youlanda.Duggar@va.gov

INFORMATION CALL:

7. FOR SOLICITATION

9. ISSUED BY

TIME

8. OFFER DUE DATE/LOCAL

b. TELEPHONE NO. (No Collect Calls)

a. NAME X Building 37, NCS (003B6C3) OPAL / National Acquisition Center Department of Veterans Affairs

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

WOMEN-OWNED SMALL BUSINESS

SMALL BUSINESS

% FOR:

SET ASIDE:

UNRESTRICTED OR

10. THIS ACQUISITION IS

CODE

325412 Hines IL 60141 1st Avenue, One Block North of Cermak

SIZE STANDARD:

NAICS:

EDWOSB

SMALL BUSINESS PROGRAM

SERVICE-DISABLED

BUSINESS

HUBZONE SMALL

1250 Employees Y

11. DELIVERY FOR FOB DESTINA-

8(A)

SMALL BUSINESS

VETERAN-OWNED

N/A N/A

14. METHOD OF SOLICITATION

13b. RATING

DPAS (15 CFR 700)

RATED ORDER UNDER

13a. THIS CONTRACT IS A

12. DISCOUNT TERMS

SEE SCHEDULE

MARKED

TION UNLESS BLOCK IS

X

CODE

16. ADMINISTERED BY

CODE

15. DELIVER TO

RFP

IFB

RFQ

Building 37, NCS (003B6C3) OPAL / National Acquisition Center Department of Veterans Affairs Section D.

Refer to Attachment A, located in VA Pharmaceutical Prime Vendor Hines IL 60141 1st Avenue, One Block North of Cermak

17a. CONTRACTOR/OFFEROR

CODE

18a. PAYMENT WILL BE MADE BY

FACILITY CODE

CODE

Section D.

Refer to Attachment A, located in VA Pharmaceutical Prime Vendor

FAX:

PHONE:

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

DUNS+4:

DUNS:

TELEPHONE NO.

See CONTINUATION Page

AMOUNT

UNIT PRICE

UNIT

QUANTITY

SCHEDULE OF SUPPLIES/SERVICES

ITEM NO.

24.

23.

22.

21.

20.

19.

SEE ADDENDUM

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER See attached excel spreadsheet for Schedule of Supplies IV Solutions and Administration Sets submit a price for the base year and all option years.

line items. To be considered for award, offerors must One award will be made in the aggregate for all mandatory may propose optional line items or other In addition to the mandatory line items, offerors Offered prices shall not exceed two decimal places. Offered commercial items in the same product line.

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.

25. ACCOUNTING AND APPROPRIATION DATA

(Use Reverse and/or Attach Additional Sheets as Necessary) See CONTINUATION Page

26. TOTAL AWARD AMOUNT (For Govt. Use Only) X 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE NOT ATTACHED.

ARE

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA 1 scan X

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

DATED ________________________________. YOUR OFFER ON SOLICITATION

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

ARE NOT ATTACHED

ARE

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30a. SIGNATURE OF OFFEROR/CONTRACTOR

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

STANDARD FORM 1449

Prescribed by GSA - FAR (48 CFR) 53.212

PREVIOUS EDITION IS NOT USABLE

(REV. NOV 2021)

AUTHORIZED FOR LOCAL REPRODUCTION

31c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 30c. DATE SIGNED 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) See attached Excel document with filename “Schedule of Supplies.” The first tab of the spreadsheet contains instructions for entering proposed items, pricing, and other information. Offerors shall submit the completed spreadsheet to the Contracting Officer with completed and signed SF-1449 and other offer documents.

Continuation of SF-1449, Block 3:

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

Contract Award/Effective Date: ___________________

Implementation Period: __________________________

Ordering Period (Base Year): _____________________

Offerors shall not enter information into the above fields.

36E79722R0012

Page 1 of Page 1 of Table of Contents

36E79722R0024

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 Youlanda.Duggar@va.gov with a scanned (PDF) copy of the signed SF-1449 and completed Schedule of Supplies spreadsheet in Microsoft Excel formatting. Please note that faxed proposals are not acceptable and will be rejected. Please note, zip files and folders are rejected by VA NAC servers, and emails with large attachments may not be received. VA suggests that offerors submit their proposals well before the deadline and confirm receipt of all attachments with the Contracting Officer listed on the SF-1449. 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/raw materials into a final product. An acceptable Letter of Commitment is required from all distributor-offerors to be eligible for award. The offeror must maintain the same manufacturer 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-COMMERCIAL PRODUCTS AND COMMERICAL SERVICES.

One award will be made in the aggregate for all mandatory line items for the base year and all four option years. To be considered for award, offerors must propose a price for all 78 mandatory line items as listed in the attached Schedule of Supplies Excel spreadsheet, 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 all mandatory line items may be rejected and receive no further consideration.

In addition to submitting an offer for the mandatory line items listed in the Schedule of Supplies, offerors are encouraged to offer their entire product line of IV solutions. These line items will include all products in your catalog related to IV solutions and administration sets other than the mandatory line items and may be awarded as an Indefinite Delivery – Indefinite Quantity (IDIQ) type contract to the lowest priced-technically acceptable offer (of the mandatory line items) if the prices are determined to be fair and reasonable. Optional line items will not be included in the total evaluated price (of the mandatory line items) to determine the lowest priced offer and the inclusion of optional line items will not increase or decrease the likelihood of being the lowest priced – technically acceptable offeror.

The offerors shall provide their current published commercial descriptive catalogs and price list(s) for the optional line items. If special catalogs or price lists are printed for the purpose of this offer, such descriptive catalogs or price lists shall include a statement indicating the special catalog or price list represents a verbatim extract from the Offeror’s commercial catalog and/or price list and identify the descriptive catalog and/or price list from which the information has been extracted.

(Refer to attached Schedule of Supplies Excel spreadsheet for product description, size, and estimates. The 3rd Tab on the Schedule of Supplies will allow offerors to submit any additional –optional line items for the Government to consider.)

Offered prices shall include a 0.50% Cost Recovery Fee (See Scope of Contract, paragraph 11).

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 “B” 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 Pharmacy Ordering Activities, except VA Emergency Pharmacy Service (EPS), under the Department of Veterans Affairs and Indian Health Service (IHS) acquire their requirements under this solicitation through the Pharmaceutical Prime Vendor (PPV) Program. EPS will acquire their product requirements directly from the product supplier. The PPV Program is a separate contract which establishes the fees for the distribution of 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 ordered via the VA PPV Program (with the exception of EPA, which orders direct from the contractor). Section 2.1, “Government Participants” lists the eligible participants under the VA PPV Program 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 products listed in the schedule for purchase through the VA PPV Program for all eligible pharmacy participants under the PPV Program or direct from the product supplier for EPS. The total annual estimated usage for VA Pharmacy, Federal Health Care Center (FHCC), pharmacies for State Veterans Homes - Option 2 (SVH), EPS, and IHS pharmacies appear 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 Type Of Contract. The contract awarded under this solicitation will be a Firm-Fixed Price, Indefinite Delivery - Requirements type contract for the mandatory line items; and a Firm-Fixed Price, Indefinite Delivery – Indefinite Quantity (IDIQ) type contract for the optional line items.

1.4 Government Purchase Compliance. For the mandatory line items, VA, FHCC, SVH (Option 2), and IHS, will purchase their requirements for the products listed in the schedule through the VA 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.4 – 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. EPS will purchase their requirements for the products listed in the schedule of supplies directly from the product supplier. Participants of the VA PPV Program include VA Pharmacy, FHCC, SVH (Option 2), and IHS pharmacies.

For the optional line items, VA, FHCC, SVH (Option 2), and IHS, will be able to purchase from the IDIQ contract, however it will not be a requirement, and there will not be ordering lock-out procedures in place for those line items.

1.5 Contract Effective Date, Implementation Period, and Ordering Period.

(A) Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF1449 and notifies the offeror (contractor) of award.

(B) Implementation Period. The timeframe beginning on the Contract Effective Date and ending at the start of the Ordering Period in which PPVs begin placing orders with the contractor for delivery to the multiple PPV distribution centers is the Implementation Period.

Contractors will be allowed a maximum of a 60-day Implementation period (but may be shorter than 60 calendar days if mutually agreed between the contractor and the Government prior to award), if the contract is awarded after 7/18/2022. If the contract is awarded prior to 7/18/2022, the Implementation period will begin when the contract is awarded and end on 9/16/2022.

The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements, “pass through program” agreements, and/or business-to-business agreements with the PPV 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 PPV is listed as attachment “A” of this solicitation. The current PPV may change and the contractor will be notified of any changes in PPV contractor during the term of the contract resulting from this solicitation. The Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPV by 15 days before commencement of the Ordering Period. Failure or refusal to reach agreement with the PPV shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions-Commercial Products and Commercial Services, Termination for Cause.

(C) Ordering Period. The Ordering Period begins at the expiration of the Implementation Period. The base year Ordering Period will be in effect for the period of one (1) year. See Paragraph 1.5 and 1.6 for Standard Operating procedures and the Delivery Schedule.

(D) At the time of contract award, the Contracting Officer shall indicate the contract Effective Date, Implementation Period, and Ordering Period on Page 2 of the SF-1449, in accordance with the timeframes specified in this section.

1.6 Standard Ordering Procedures. All products awarded under this solicitation will be ordered on a “pass through basis.” Pharmacy ordering facilities other than Emergency Pharmacy Service (EPS) will place their orders through the VA PPV, and the contractor shall deliver the awarded items directly to the ordering facilities. The VA PPV invoices the facility for products shipped, and the facility makes payment directly to the VA PPV.

1.7 Delivery Schedule. All orders shall be delivered to the address specified by ordering facility within 10 calendar days from order receipt, unless an alternate timeframe is agreed to by ordering facility and contractor. Offeror shall indicate below if contracted delivery time of less than 10 calendar days can be offered:

1.8 Special Ordering Procedures and Requirements for EPS. Orders for Emergency Pharmacy Service (EPS) will be placed directly with the product supplier in lieu of a “pass through basis.” Orders shall be shipped directly from the product supplier to each individual facility. The contractor invoices the facility for products shipped, and the facility makes payments directly to the contractor.

(a) Depending on the mission being supported, EPS may place one large order with multiple points of delivery, or several current smaller orders, each with a separate delivery location. Coordination of delivery will be made between the product supplier and each individual facility, as indicated by each order.

(b) EPS orders will require the maximum shelf life possible, with no lot number changes per order preferable; at a minimum, no lot number changes per case, and when possible, no lot number changes per pallet. This requirement may affect the delivery time frame and shall be coordinated between product supplier and each individual facility.

(c) Although the estimated usage for EPS has been included in the estimated annual requirements for each line item, estimated usage for any year may fluctuate and should an emergency situation occur, it may require stock to be increased and/or replaced.

1.9 Contract Duration. The contract resulting hereunder will be in effect for the duration of the Implementation Period described in Section 1.4 plus one (1) year Ordering Period with four (4) one (1) year pre-priced option (ordering) periods that may be exercised unilaterally by the Government in accordance with FAR 17.207 and FAR 52.217-9.

1.10 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 VA PPV. Because the PPV receives orders and payment for the supplies sourced from this solicitation, special contract considerations apply.

Under this resulting contract, the contractor will be receiving payments from the PPV program instead of directly from the Government (for orders other than those from EPS). 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.

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 pharmacies for the Department of Veterans Affairs (VA) facilities, including Emergency Pharmacy Service (who orders direct from the contractor, not via the VA PPV program)

· All pharmacies for Indian Health Service (IHS) facilities

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

· All pharmacies for 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. The database identifies each state veteran home as option 1 or 2.

2.2 State Veteran Homes (SVHs). 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 Estimated Quantities. The quantities in the schedule reflect the combined usage of all VA pharmacies (inclusive of FHCC, EPS, and SVH), and IHS pharmacies currently participating in the VA PPV Program. 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 products 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.

2.4 Addition of Other Government Agencies to the Contract. Upon mutual agreement between the contractor and the Government, a limited number of other Government agencies (OGAs) serviced by the VA PPV program, including but not limited to, Immigration and Customs Enforcement (ICE), and Option 1 State Veteran homes may be added to the contract by modification.

2.5 Training. The contractor shall provide on-site or virtual orientation and training on use of all products contained in this solicitation if required by the facility. The contractor shall contact the nursing In-Service Director and Pharmacy service of each facility to determine the facilities training requirements and establish a schedule date for training. All the facilities should either have been trained or schedule for training within 60 days from date of award if the facility requests training. Qualified contractor personnel will conduct training. All training costs will be the responsibility of the contractor.

3. PRODUCT REGISTRATION

Product information pertaining to all items offered under this solicitation, including the offeror’s unique National Drug Code(s) (NDC) or Universal Product Number (UPN), must be submitted to First Data Bank, Medispan and Multum prior to the start of the Ordering Period, if applicable for the product type. A New Product Submission Form can be obtained by contacting First Data Bank at (800) 633-3453, extension 566, or information can be obtained 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 or EPS issue an order with the contractor, and the complete order quantity is not delivered to the customer within the delivery timeframe specified in section 1.6. 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 and strength of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number or an 11-digit UPN for all items offered; NDCs and UPNs must be unique to the offering company and to the product being supplied.

6. BAR CODING

All 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.

For applicable products, 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.

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. 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. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct eleven-digit NDC Number or eleven-digit UPN 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. For products with NDCs, the first five numbers of the eleven-digit NDC 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 applicable offered items. If an offeror 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.

8. DRUG APPLICATION/FDA APPROVAL

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 products): 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.

For offered products categorized as medical devices, offerors shall indicate their FDA 510K approval number or numbers for the offered products in the Schedule of Supplies. The Government will use this number to verify that the FDA 510K approval is present on the FDA’s database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm). If an offeror’s approval is not present on the FDA’s website (e.g. a new approval), the FDA approval letter shall be provided along with the offer. If the offered products are exempt from FDA 510K approval, the offeror shall indicate as such and shall provide evidence of the applicable exemption at the time of offer submission.

9. RECALLS

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

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).

10. 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.

11. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

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

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

(B) Contract sales reports are due to the 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.

11.2 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.

11.3 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 Products and Commercial Services, Termination for Cause.

11.4 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.

12. GUARANTEED MINIMUM (optional items – IDIQ)

GUARANTEED MINIMUM: The minimum dollar value that the Government agrees to order under the optional IDIQ items is $500.00 (contract total for all awarded optional line items). If the Contractor receives total orders for less than the guaranteed minimum during the ordering period, inclusive of any optional ordering periods, the Government will pay the difference between the amount ordered and the minimum dollar value.

(1) Payment of any amount due under this requirement shall be contingent upon the Contractor’s timely submission of sales reports and payment of Cost Recovery Fee during the period of the contract. Refer to Scope of Contract, Section 11 for instructions and deadlines of sales reports and payment of the Cost Recovery Fee.

(2) The guaranteed minimum applies only if the contract expires or contract is terminated for the convenience of the Government. The guaranteed minimum does not apply if the contract is terminated for cause or the contractor agrees to a “no cost” termination.

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 12.7 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 12.3 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 12.7, 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 immediately 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 on the Schedule of Supplies Excel spreadsheet (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/raw materials into a final product.

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 for the duration of the contract period, unless the Contracting Officer…