02_VendorResponse_65IB_R8_6212018.docx

02 - VENDOR RESPONSE DOCUMENT

ALL OFFERORS MUST COMPLETE THIS DOCUMENT.

PLEASE PAY ATTENTION TO THE APPLICABILITY NOTES

PROVIDED IN THE TABLE OF CONTENTS

AND AT THE BEGINNING OF EACH

OF THE FOUR SECTIONS OF THIS DOCUMENT.

PLEASE UTILIZE THE CHECKLIST

AT THE END OF THIS DOCUMENT.

TABLE OF CONTENTS

VENDOR RESPONSE: All offerors must complete this section.

Information / Clauses Applicable Only To Offers For SIN 42-2a

52.223-3 Hazardous Material Identification and Material Safety Data (Jan 1997,

COMMERCIAL SALES PRACTICES: All offerors must complete this section.

PAST PERFORMANCE EVALUATION: Only complete this section if this is a new Federal Supply Schedule (FSS) offer and you do not have a current FSS contract with either General Services Administration (GSA) or Department of Veterans Affairs (VA).

Contractor Past Performance References 45 SMALL BUSINESS SUBCONTRACTING PLAN: Only complete this section if you are classified as an “other than small business” (or are affiliated with an other than small business) and your offer will be valued in excess of $700,000 for the ten year contract period including the base and all option periods.

Small Business Subcontracting Plan Template (Aug 2017) 49

PROPOSAL CHECKLIST 57

SIGNATORY AUTHORITY FOR OFFERS AND CONTRACTS / COMPANY INFORMATION

The purpose of this document is to clearly identify who has been delegated the authority to sign your Federal Supply Schedule (FSS) offer or contract on behalf of the named firm as well as identify pertinent company information. Pursuant to our policy, the only person(s) with the ability to delegate authority is an officer of the company. Therefore, please list the officers of the company in block 6 of the form. In block 7, please list those persons to whom authority has been delegated to sign, negotiate and/or administer your Federal Supply Schedule (FSS) offer or contract. Finally, blocks 15, 16, 17 must be signed by an officer of the company (individual listed in block 6) in order for our office to accept the authority. If you require additional space, you may use a properly titled attachment.

NOTE: All items must be completed; insert N/A if information is not applicable. Definitions are provided on the following page.

5. COMPANY INFORMATION

A. NAME

B. STREET ADDRESS

C. CITY

D. STATE

E. ZIP CODE

6. NAMES OF OFFICERS, OWNERS, OR PARTNERS

A. PRESIDENT

B. VICE PRESIDENT

C. SECRETARY

D. TREASURER

E. OTHER OFFICERS, OWNERS OR PARTNERS (add attachments if necessary)

7. PERSONS AUTHORIZED TO SIGN OFFERS AND CONTRACTS ON BEHALF OF THE COMPANY (Indicate if Agent)

8. BUSINESS INFORMATION (Refer to FAR 52.212-1(a), 19.101 and 19.102)

A. SIZE OF BUSINESS

|_| SMALL BUSINESS (Complete block 9)

|_| OTHER THAN SMALL BUSINESS

B. AVERAGE NUMBER OF EMPLOYEES

(Including affiliates) FOR THE PRECEDING 12 MONTHS C. AVERAGE ANNUAL COMPANY SALES OR RECEIPTS (Including affiliates) FOR PRECEDING THREE (3) FISCAL YRS $

|_| DISADVANTAGED

|_| WOMEN-OWNED

|_| HUBZONE

|_| VETERAN-OWNED

|_| SERVICE DISABLED VETERAN-OWNED

|_| 8(A)

|_| MANUFACTURER / PRODUCER

|_| DEALER

|_| DISTRIBUTOR

|_| SERVICE ESTABLISHMENT

|_| RESELLER

TAX IDENTIFICATION NUMBER:

DUNS:

A. MANUFACTURING

B. WAREHOUSE

A. DATE

B. AMOUNT

CERTIFICATION -- I certify that information supplied herein (including all pages attached) is correct and that neither the company nor any person (for concern) in any connection with the company as a principal or officer, so far as it known, is now debarred or otherwise declared ineligible by any agency of the Federal Government from making offers for furnishing materials, supplies, or services to the Government or any agency thereof.

03/2018

AGENT AUTHORIZATION (MARCH 2018)

This letter is to be used in conjunction with solicitation clause K-FSS-1, Authorized Negotiators, to authorize a third party agent to act on your company’s behalf in matters relating to your VA FSS proposal/contract. The form of this letter permits you to delineate agent roles and to limit those roles as needed. This letter shall only be signed by an officer, owner, or partner of the offeror/contractor who is listed on the offeror/contractor’s Signatory Authority Form.

For solicitation/contract number , the undersigned offeror/contractor hereby authorizes the below agent(s) to act as agent(s) for said offeror/contactor with said specific authority delegated from the contractor to the agent(s). The authority of the agent(s) is limited to exact and specific delegations.

AGENT INFORMATION

Agent Name:

Company Name:

Company Address:

Phone Number:

AGENT AUTHORITY

|_|Pre-Award |_|Post-Award - Signatory Authority |_|Pre-Award |_|Post-Award - Negotiate Changes |_|Pre-Award |_|Post-Award - Contract Administration |_|Pre-Award |_|Post-Award - Other:

AGENT INFORMATION

Agent Name:

Company Name:

Company Address:

Phone Number:

AGENT AUTHORITY

|_|Pre-Award |_|Post-Award - Signatory Authority |_|Pre-Award |_|Post-Award - Negotiate Changes |_|Pre-Award |_|Post-Award - Contract Administration |_|Pre-Award |_|Post-Award - Other:

DURATION OF AUTHORITY

|_| Agent authority valid until revoked.

|_| Agent authority valid for the following period:

Signature of Offeror/Contractor (wet signature required): ___________________________________

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 17 & 30

1. REQUISITION NUMBER

N/A PAGE 1 of

2. CONTRACT NO.

M5-Q50A-03-R8

6. SOLICITATION ISSUE

DATE: 6/21/2018

FEDERAL SUPPLY SCHEDULE HELPDESK

VA NATIONAL ACQUISITION CENTER

FEDERAL SUPPLY SCHEDULE SERVICE 003B6B

PO BOX 76, BLDG 37

HINES, IL 60141

OVERNIGHT DELIVERY SHOULD BE MAILED OR HAND DELIVERED TO THE ADDRESS LOCATED IN BLOCK 16

|_| SMALL BUSINES

|_| 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)

Size Standards: See page 17 for NAICS codes and size standards under this solicitation.

11. DELIVERY FOR FOB DESTINATION UNLESS BLOCK IS MARKED

|_| SEE SCHEDULE

12. DISCOUNT TERMS

See Summary of Award

14. METHOD OF SOLICITATION

1ST AVENUE, 1 BLOCK NORTH OF 22ND STREET, BLDG 37 HINES, IL 60141

FACILITY

CODE

TELEPHONE NO.

BELOW IS CHECKED |_| SEE ADDENDUM

FSC CLASSES

FSC GROUP 65, PART I, SECTION B

Drugs, Pharmaceuticals & Hematology Related Products

SEE CONTINUATION OF SF-1449 FOR SCHEDULE OF ITEMS

(Attach reverse and/or attach additional sheets as necessary)

25. ACCOUNTING AND APPROPRIATION DATA

7974537B0161441V36122002580

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

ESTIMATED VALUE $

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

YOUR OFFER ON SOLICITATION (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS: See Summary of Award.

30a. SIGNATURE OF OFFEROR/CONTRACTOR (wet signature)

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

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

|_|RECEIVED |_|INSPECTED |_| ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

PARTIAL

FINAL

42b. RECEIVED AT (Location)

02– Vendor Response Document M5-Q50A-03-R8

CONTINUATION OF SF 1449 – BLOCKS 19-21, SCHEDULE OF ITEMS

DESCRIPTION

ESTIMATED ANNUAL SALES

CHECK ITEM OFFERED

325611

311514

325611

This includes but is not limited to medicated shampoos, soaps, rinses, washes, creams, lotion, gels, powders, ointments, etc.; antiseptic washes, gels, lotions, etc.; and hemostatic/antihemorrhagic agents. Note: This does not include impregnated/treated dressings (e.g. medicated bandages, gauze, etc.) which fall under Schedule 65 II A, Medical Equipment and Supply, SINs A-2, A-3, and A-4 or Schedule 65 II C, Dental Equipment and Supplies. Topical Dressings with NDC numbers fall under SINs 42-2a and 42-2b, as appropriate. This SIN does not include common antibacterial soaps/gels/hand sanitizers as these belong under GSA Schedule 75, Office Products/Supplies and Services and New Products/Technology, SIN 75-85 Restroom Products.

325611 Introduction of New Products (INP)

Note: When a VA National Contract is awarded, items that are the same or similar and appear on the FSS may be unavailable from the FSS for those ordering activities that are mandatory users of the awarded National Contract. Government agencies that participate in a national committed use contract are required to purchase the products awarded on the national contract from the national contractor. Although Government agencies participating in the national contract would not be permitted to purchase the same or similar items from FSS contracts without a waiver issued by the ordering activity, any FSS contractor may maintain these items on its FSS contract for sale to all other authorized users of the schedule.

* SIN 42-2A – COVERED DRUGS: A covered drug is a “branded” drug dispensed only by prescription. This includes: 1) Single-source drugs – drugs generally marketed under an original New Drug Application approved by the Food and Drug Administration (FDA); 2) Innovator multiple-source drugs – drugs that were originally marketed under an original NDA approved by the FDA; and 3) Specified biological products approved by the FDA through a biological license application (See 21 CFR 600.3 for a list). Products marketed under an abbreviated NDA (ANDA) and over-the-counter (OTC) products, including OTC products approved by the FDA as innovators under NDAs, are not classified as covered drugs. An authorized generic, however, is classified as a covered drug. An authorized generic is a “generic” version of a brand product that is marketed under the same NDA as the brand, as opposed to an ANDA.

SCOPE OF SOLICITATION (JUN 2018)

The Federal Supply Schedule (FSS) program is also known as the GSA Schedules Program or the Multiple Award Schedule (MAS) Program. The FSS program is directed and managed by GSA and provides Federal agencies with a simplified process for obtaining commercial supplies and services at prices associated with volume buying. Indefinite-delivery, indefinite quantity contracts are awarded to provide supplies and services at stated prices for given periods of time. GSA has delegated authority to the VA to manage the Schedules for medical supplies under the VA FSS program.

This solicitation is issued to establish contracts which may be used on a nonmandatory basis by eligible users, as a source of supply for the supplies or services described herein, for domestic and/or overseas delivery. At a minimum, contract holders are required to deliver their products within the 48 contiguous states, Alaska, Hawaii, Puerto Rico, Washington, DC, and U.S. territories. Domestic delivery also includes a port or consolidation point, within the aforementioned areas, for orders received from overseas activities. Offerors who cannot provide the required geographic coverage will not be considered for award. This solicitation further requires that offered prices cover delivery to destinations (i.e. F.O.B. destination) located within the 48 contiguous states and the District of Columbia. Offerors can choose whether or not prices cover delivery f.o.b. destination to Alaska, Hawaii, and the Commonwealth of Puerto Rico. Additionally, the solicitation defines the number of calendar days after receipt of order (ARO) within which delivery must be made.

Special Item Numbers (SINs): FSS solicitations set forth broad categories of accepted products/services, referred to as Special Item Numbers (SINs), listed in the Continuation of SF1449 in Vendor Response Document 02. Offerors are not required to submit their entire catalog of products/services but are free to choose which items they will offer as long as those items fall within one of the solicitation’s pre-defined SIN categories. Items that do not fall within one of these SINs are considered to be out of scope of the solicitation and cannot be awarded. An item’s acceptability under the schedule may be further restricted by the Trade Agreements Act, limitations on certain types of commercial items, and a determination of fair and reasonable pricing.

Additional Product Restrictions: Please note that the scope of this schedule is further limited by the following:

· Drug Supply Chain Security Act (DSCSA): The contractor shall follow all appropriate requirements as implemented in the Drug Supply Chain Security Act (DSCSA), including all applicable traceability and licensing requirements.

· FDA Regulatory Requirements: Offered products shall be in compliance with all applicable U.S. Food and Drug Administration (FDA) regulations and requirements, including but not limited to bar code labeling, therapeutic equivalence, new drug applications (NDA) or abbreviated NDA (ANDA), labeler codes, National Drug Codes (NDC), and Good Manufacturing Practices (GMP). Products not in compliance with applicable regulations and requirements will not be considered for award under this solicitation.

· Drugs: All items classified as drugs by the FDA must have an NDA, ANDA, or comply with an approved monograph.

· Natural/Homeopathic Products: FSS will not award under this schedule any items considered to be herbal/bontanical supplements, natural or homeopathic remedies unless FDA approved as evidenced by an NDA, ANDA, or compliance with an approved monograph.

· Dietary Supplements / Vitamins: Vitamins are permitted on schedule as dietary supplements provided that they meet all the requirements of the Dietary Supplement Health and Education Act (DSHEA) and FDA regulations. Manufacturers and distributors are prohibited from marketing products that are adulterated or misbranded and are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all DSHEA and FDA regulations.

· Nutritional Supplements / Medical Foods: Only items meeting the FDA’s definition of medical food will be permitted on schedule as a nutritional supplement. A medical food, as defined in section 5(b)(3) of the Orphan Drug Act, 21 USC 360ee(b)(3), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.

· EXCEPTIONS: Exceptions to the above listed restrictions may be made based on medical need, facility demand, and evidence based clinical reasons.

New Items vs. Refurbished or “Grey Market Goods” This solicitation is for the award of new items only. The Contractor shall provide only new equipment and new parts for the required products described herein. Absolutely no “grey market goods” or refurbished products shall be provided under any delivery order. Grey market goods are defined as genuine branded goods sold outside of an authorized sales-territory (or by non-authorized dealers in an authorized territory) at prices lower than being charged in authorized sales territories (or by authorized dealers). All equipment must be covered by the manufacturer’s warranty.

Trade Agreements Act The Trade Agreements Act is applicable to all Schedules. Except as noted below regarding certain items under SIN 42-2a, ONLY US-made or designated country end products shall be awarded to responsible VA FSS contractors. It is the offeror’s responsibility to verify that all offered products are U.S. made or designated country end products as defined in clause FAR 52.225-5. When an item consists of components from various countries and the components are assembled in an additional country, the test to determine country of origin is “substantial transformation” (see FAR 25.001(c)(2)). Offerors requiring a determination on substantial transformation can go to the US Customs and Border Protection (CBP) Office of Regulations and Rulings. Please note that CBP has issued decisions regarding pharmaceuticals which determined that the location where substantial transformation took place was the source of the Active Pharmaceutical Ingredient (API) and not the location where the product was mixed, measured and formulated.

Trade Agreements Act – Non-Availability Determination - Special Item Number 42-2A product items (single source drug, innovator multiple source drug, and any biological product identified under Section 600.3 of Title 21, CFR) that are not substantially transformed in the U.S. or a designated country under 52.225-5 Trade Agreements must be included in the offeror’s proposal to obtain a Federal Supply Schedule 65IB contract and listed as other end products as required by 52.212-3(g)(5)(ii). Offerors of these items must complete the Trade Agreements Act Non-Availability Determination Request located within this document.

Commercial Items - Limitations Per GSA regulations at 538.271(a), MAS awards are for commercial items as defined in FAR 2.101. Certain types of “custom” items fall under this definition as modified commercial items. For example, FSS accepts configurable items, such as configurable wheelchairs, and custom count items, such as pharmaceutical tablets packaged in quantities specifically for the Government. FSS, however, has made a business decision not to award contracts for the following:

· Custom Packs

· Non-Configurable Custom Products Made to Individual Specifications, including, but not limited to, such items as custom orthotics, custom dental products, and prescription eyeglasses.

Additionally, per the commercial item definition at FAR 2.101, FSS cannot award contracts to installation, maintenance, and repair service companies who do not also provide similar services to the general public (i.e. Government only service providers).

Notice of Additional Requirements - Ordering Level In addition to the terms and conditions set forth in this solicitation, the contractor may, in the performance of orders issued under this contract, be responsible for further requirements at the ordering level. For more information on these potential, additional requirements, please see the note in Solicitation Document 01 after FAR clause 52.216-18 Ordering.

Please note that the VA does not promote the use of any company’s specific Schedule contract. Vendors should be aware that obtaining a VA Schedule contract is not a guarantee of sales. Vendors awarded a VA Schedule contract will need to market their supplies and services to Government customers as they would to commercial customers. A listing of eligible schedule users can be found at on GSA’s website at http://gsa.federalschedules.com/resources/eligible-gsa-schedule-users/.

B-FSS-96 ESTIMATED SALES (NOV 1997)

Note: Estimated sales figures for each SIN are based on annual total sales for domestic and overseas under the FSS program and thus reflect sales to multiple vendors under each SIN.

The "Estimated Sales" column of the Schedule of Items shows (1) a twelve-month reading of purchases in dollars or purchases in units as reported by the previous Contractor(s), or (2) estimates of the anticipated dollar volume where the item is new. The absence of a figure indicates that neither reports of previous purchases nor estimates of sales are available.

L-FSS-400 INTRODUCTION OF NEW SERVICES/PRODUCTS (INSP) (NOV 2000)

(d) If the Contractor has an existing Multiple Award Schedule contract, the Government may, at the sole discretion of the Contracting Officer, modify the existing contract to include the INSP/SIN item in accordance with 552.238-81, Modification (Federal Supply Schedule).

BUSINESS SIZE DETERMINATION & NAICS CODE DESIGNATION (AUG 2017)

The Small Business Administration (SBA) has established numerical definitions, or “size standards,” for all for-profit industries based upon NAICS codes. Size standards represent the largest size that a business (including its subsidiaries and affiliates, both foreign and domestic) may be in order to be classified as a small business concern.

The NAICS codes that have been identified as being applicable to this solicitation are listed below along with their corresponding size standards (effective as of 2/26/2016). Due to regulatory restrictions, wholesaler NAICS codes are not used for Government procurement purposes. For the procurement of supplies, only manufacturer NAICS codes are used. This does not preclude a dealer or distributor from submitting a proposal under the solicitation. If you are a nonmanufacturer (e.g. wholesalers, dealers, distributors, and resellers), then the applicable size standard is 500 employees as specified in FAR 52.212-1(a).

A business may qualify as a small business under some NAICS codes and as an “other than small” business under other NAICS codes. However, in order to be recognized as a small business at the base FSS contract level, you must qualify as a small business under each NAICS code representing your product/service offerings. You may be required to represent your size status at the delivery or task order level based upon the NAICS code(s) applying to the items/service specific to that order. For the purposes of this solicitation proposal, please complete the three designation sections below.

Select the NAICS code(s) representing each category of your product offering(s), and select from the dropdown menu if you are a manufacturer, non-manufacturer, or both for applicable NAICS code(s).

|_| 325412 Pharmaceutical Preparation Manufacturing / 1,200 employees |_| 325611 Soap and Other Detergent Manufacturing / 1,000 employees Select the primary NAICS code which represents the greatest percentage of line items for your offered product(s).

|_| 325412 Pharmaceutical Preparation Manufacturing / 1,200 employees |_| 325611 Soap and Other Detergent Manufacturing / 1,000 employees Select the primary Federal Supply Code (FSC) which represents the greatest percentage of line items for your offered product(s).

|_| 6505 Drugs and Biologicals |_| 6508 Medicated Cosmetics and Toiletries

INFORMATION / CLAUSES APPLICABLE ONLY TO OFFERS FOR SIN 42-2A

Covered Drug Manufacturers: The following clauses and provisions apply only to drugs covered under the Veterans Health Care Act of 1992, Public Law 102-585, Sect. 603 (38 U.S.C. 8126) (PL), and listed on FSS contracts under SIN 42-2A. Please note, additional information regarding PL obligations and responsibilities is, from time to time, communicated to manufacturers through “Dear Manufacturer Letters.” These communications, as well as other important PL updates and information, may be found at http://www1.va.gov/oamm/oa/nac/fsss/pharmaceuticals.cfm or by contacting the FSS helpdesk at helpdesk.ammhinfss@va.gov. Manufacturers of influenza vaccines, please note that information specific to these covered products is contained in the Dear Manufacturer Letter dated March 31, 2004.

MANUFACTURER'S FSS PRICE LIST ELECTION FORM UNDER PUBLIC LAW 102-585

38 U.S.C. 8126(a) requires at least a 24% discount be given to "a Federal agency" that procures a covered drug under a depot contracting system or through the Federal Supply Schedule (FSS). Section 8126(b) describes the relevant "Federal agencies" as VA, DoD, PHS (including Indian Health Service), and Coast Guard. As you probably know, although these four Federal agencies place the overwhelming majority of all pharmaceutical orders made on the FSS, there are many other governmental or not-for-profit organizations which are authorized by Congress or the General Services Administration to use the FSS. Non-Federal-agency users of the FSS are not entitled to Federal Ceiling Prices (FCPs) established under the Law, unless manufacturers elect to give them the benefit of the FCPs. By publishing a single FSS price list after the award of a contract, manufacturers will be offering to sell their products to all FSS users at the same price, regardless of whether that price reflects the FCP.

At this time, we would like to point out some of the ramifications of such a decision and ask each covered-drug manufacturer to formally elect to offer a single price to all FSS users or to adopt a dual price list (one for "the Federal agencies" and one for other FSS users and State Veteran Homes) whenever the FCPs of products are below what the FSS contract's most favored customer (MFC) price would be.

In deciding whether to elect a single or dual price list approach, each manufacturer should consider, in addition to the sections of the Law mentioned above, the requirements of Section 8126(d). That provision deals with establishing FCPs in the second and subsequent years of a multi-year contract and requires two computations; the lower of the two computed prices becomes the second or subsequent year's multi-year contract ceiling price.

Where the FCP and FSS-MFC price are approximately the same or where the FSS negotiated price is lower than the FCP, it may not seem necessary to make an election because there would be no current economic impact from the choice of a single or dual price list policy. (There would already be a single FSS price with no alternative to choose from.) However, even in these situations, VA has decided that each manufacturer must elect to establish a single FSS contract price for all users or dual price lists (where applicable) for the remainder of the contract period.

At this time, the beginning of the solicitation for the new contract period of the schedule, your company must elect either a single or dual price list granting the benefits of FCPs to all FSS users where appropriate or a dual FSS price list, one version being applicable only to “the Federal agencies”. The latter election may be implemented on an item-by-item basis so that, where the FCP is lower than an MFC price, a manufacturer may elect to allow the ceiling price figure to stand as the all-FSS selling price for some items but not for others.

Also, it should be remembered that the FSS contract price (and not the FCP, unless the Manufacturer specifies otherwise) will be subject to the FSS Price Reduction Clause with its comparable customer discount tracking mechanism.

We ask that an authorized representative of your company make the required election using the below form. If your company elects separate FSS price lists, it will have the responsibility of providing the correct price list to the “Federal Agencies” and all other FSS users.

Please fill in and execute the single paragraph below that reflects the Manufacturer's choice. Note: This section only applies to companies offering products under SIN 42-2a.

1. [Manufacturer Name] _____________________________________ through the undersigned, its officer or agent authorized to make this election, has read and understood VA's "Dear Manufacturer" letter concerning election of an FSS price list policy. Said manufacturer hereby elects to publish a single annual FSS price list that adopts for all FSS users the current Federal ceiling price (FCP) figure(s) for any covered drug whose FCP is below the most favored customer (MFC) price. This election will be effective immediately upon award of a contract and will remain in effect through the termination of the FSS Contract.

TITLE

**************************************** (OR) **************************************

2. [Manufacturer Name] ____________________________________ through the undersigned, its officer or agent authorized to make this election, has read and understood VA's "Dear Manufacturer" letter concerning election of an FSS price list policy. Said manufacturer hereby elects NOT to publish a single FSS price list extending Federal ceiling price benefits to all FSS users, but rather, where a covered drug's FCP is lower that the company's MFC price, to publish separate price lists, one containing FSS contract prices to non-covered Federal-agency users and one containing those FCP capped prices which the Manufacturer wishes to extend only to the covered Big 4 (VA, DoD, PHS/IHS, and Coast Guard) Federal agencies. This election will be effective immediately upon award of a contract and will remain in effective through the termination of the FSS contract.

TITLE

MASTER AGREEMENTS AND PHARMACEUTICAL PRICING AGREEMENTS (SEP 2010)

Note: This section only applies to companies offering products under SIN 42-2a.

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

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

PUBLIC LAW 102-585, SECTION 603, FIRST YEAR DESIGNATION FOR MULTI-YEAR COVERED DRUG CONTRACTS Note: This section only applies to companies offering products under SIN 42-2a.

Pursuant to Public Law 102-585, Section 603, Veterans Health Care Act of 1992 (the Public Law), this notice is intended to explain the continuity of Public Law administration for Federal Supply Schedule (FSS) contracts with covered drugs awarded under an open and continuous solicitation. The first year of a multi-year contract period is an opportunity for contractors to calculate their Federal Ceiling Prices (FCP) without being subject to the limitation of a dual calculation. To meet the requirements of the Public Law, VA has determined that the first year of the new Pharmaceutical FSS multi-year contracts for purposes of the FCP calculation was 2009 and that 2014 will be the next “first year,” if VA does not exercise its rights under the Option To Extend Term of the contract clause.

For subsequent years of the contract, excluding the designated first year, the dual calculation will apply when performing the contractor’s follow-on years’ FCP calculations. New covered drugs added to an existing FSS contract vehicle or to a recently awarded contract vehicle shall be subject to the Department’s policy on implementing provisional, temporary, and permanent FCPs.

VA has determined that continuous contract coverage (i.e., provision of the covered drug under the FSS), as required by the Public Law, can be achieved through a combination of an Interim FSS Agreement, a previous FSS contract, and current FSS contract.

Pursuant to the Master Agreement, the contractor is still required to submit Non-FAMP (Non-Federal Average Manufacturer’s Price) calculations to VA by November 15th of each year. FCP calculations will still be determined by using Calendar Year data and pertinent contract information. Contractor requests for modifications to incorporate the updated pricing calculations under the current and follow-on contract vehicles still must be submitted to VA by the published deadlines to ensure a January 1st effective date. Contractors who do not meet the deadlines may be subject to penalties as prescribed by the Public Law.

TRADE AGREEMENTS ACT NON-AVAILABILITY DETERMINATION REQUEST

Note: This section is only to be completed by those proposing items that are not U.S.-made or Trade Agreements Act designated country end products.

NDC

NDC

NDC

The above covered drugs are not substantially transformed in the U.S or a designated country under 52.225-5 Trade Agreements. [Company Name] verifies that the above, currently marketed NDCs have no TAA compliant versions, including authorized generics. I understand that the VA’s contracting officer may make a non-availability determination at the base FSS contract level for these 42-2A product items based upon statements in this request as well as my representations in SAM.gov.

I have revised our SAM.gov representations under 52.212-3(g)(5) and 52.225-6 to reflect that the items being offered are not U.S.-made or designated country end products as set forth at 52.225-5 Trade Agreements, and I agree to notify our VA FSS Contracting Officer should the facts as set forth in this letter or our SAM.gov representations change. I recognize that these items will be subject to Public Law 102-585, Section 603 (38 U.S.C. § 8126) pricing methodology.

Printed name and title of authorized representative

INFORMATION / CLAUSES APPLICABLE TO ALL SIN CATEGORIES__________

552.238-78 SCOPE OF CONTRACT (ELIGIBLE ORDERING ACTIVITIES) (JUL 2016, TAILORED)

Note: State Vet Homes with sharing agreements are also included as eligible ordering activities.

(a) This solicitation is issued to establish contracts which may be used on a nonmandatory basis by the agencies and activities named below, as a source of supply for the supplies or services described herein, for domestic and/or overseas delivery.

(1) Executive agencies (as defined in FAR Subpart 2.1) including nonappropriated fund activities as prescribed in 41 CFR 101-26.000;

(2) Government contractors authorized in writing by a Federal agency pursuant to FAR 51.1;

(3) Mixed ownership Government corporations (as defined in the Government Corporation Control Act);

(4) Federal Agencies, including establishments in the legislative or judicial branch of government (except the Senate, the House of Representatives and the Architect of the Capitol and any activities under the direction of the Architect of the Capitol).

(5) The District of Columbia;

(6) Tribal governments when authorized under 25 USC 450j(k);

(7) Tribes or tribally designated housing entities pursuant to 25 U.S.C. 4111(j);

(8) Qualified Nonprofit Agencies as authorized under 40 USC 502(b); and

(9) Organizations, other than those identified in paragraph (d) of this clause, authorized by GSA pursuant to statute or regulation to use GSA as a source of supply.

(b) Definitions. Domestic delivery is delivery within the 48 contiguous states, Alaska, Hawaii, Puerto Rico, Washington, DC, and U.S. territories. Domestic delivery also includes a port or consolidation point, within the aforementioned areas, for orders received from overseas activities.

Overseas delivery is delivery to points outside of the 48 contiguous states, Washington, DC, Alaska, Hawaii, Puerto Rico, and U.S. territories.

(c) Offerors are requested to check one of the following boxes:

|_| Contractor will provide domestic and overseas delivery.

|_| Contractor will provide overseas delivery only.

|_| Contractor will provide domestic delivery only.

(d) The following activities may place orders against Schedule contracts:

(1) State and local government may place orders against Schedule 70 contracts, and Consolidated Schedule contracts containing information technology Special Item Numbers, and Schedule 84 contracts, on an optional basis; PROVIDED, the Contractor accepts order(s) from such activities;

(2) The American National Red Cross may place orders against Federal Supply Schedules for products and services in furtherance of the purposes set forth in its Federal charter (36 U.S.C. § 300102); PROVIDED, the Contractor accepts order(s) from the American National Red Cross; and

(3) Other qualified organizations, as defined in section 309 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. § 5152), may place orders against Federal Supply Schedules for products and services determined to be appropriate to facilitate emergency preparedness and disaster relief and set forth in guidance by the Administrator of General Services, in consultation with the Administrator of the Federal Emergency Management Agency; PROVIDED, the Contractor accepts order(s) from such activities.

(4) State and local governments may place orders against Federal Supply Schedules for good or services determined by the Secretary of Homeland Security to facilitate recovery from a major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121, et seq.) to facilitate disaster preparedness or response, or to facilitate recovery from terrorism or nuclear, biological, chemical, or radiological attack; PROVIDED, the Contractor accepts order(s) from such activities.

(e) Articles or services may be ordered from time to time in such quantities as may be needed to fill any requirement, subject to the Order Limitations thresholds which will be specified in resultant contracts. Overseas activities may place orders directly with schedule contractors for delivery to CONUS port or consolidation point.

(f) (1) The Contractor is obligated to accept orders received from activities within the Executive branch of the Federal Government.

(2) The Contractor is not obligated to accept orders received from activities outside the Executive branch; however, the Contractor is encouraged to accept such orders. If the Contractor elects to accept such orders, all provisions of the contract shall apply, including clause 552.232-79 , Payment by Credit Card. If the Contractor is unwilling to accept such orders, and the proposed method of payment is not through the Credit Card, the Contractor shall return the order by mail or other means of delivery within 5 workdays from receipt. If the Contractor is unwilling to accept such orders, and the proposed method of payment is through the Credit Card, the Contractor must so advise the ordering activity within 24 hours of receipt of order. (Reference clause 552.232-79, Payment by Credit Card.) Failure to return an order or advise the ordering activity within the time frames of this paragraph shall constitute acceptance whereupon all provisions of the contract shall apply.

(g) The Government is obligated to purchase under each resultant contract a guaranteed minimum of $2,500 (two thousand, five hundred dollars) during the contract term.

(h) All users of GSA’s and VA’s Federal Supply Schedules, including non-Federal users, shall use the schedules in accordance with the ordering guidance provided by the Administrator of General Services. GSA encourages non-Federal users to follow the Schedule Ordering Procedures set forth in the Federal Acquisition Regulation (FAR) 8.4, but they may use different established competitive ordering procedures if such procedures are needed to satisfy their state and local acquisition regulations and/or organizational policies.

AS8005 MANUFACTURING FACILITIES/PLACE OF PERFORMANCE (SEP 2010)

1. The U.S. Food and Drug Administration (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 8 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 FDA, or shall have had an acceptable report from the last FDA facility inspection on record. In the absence of a current GMP evaluation, an offeror is required to include with its proposal documentation on the acceptable outcome of a FDA facility inspection that occurred more than two years prior to submission of the offer.

2. For any Nutritional/Dietary Supplements offered, documentation of clinical studies that were performed on the offered products pertaining to the therapeutic treatment of patients may be required by the Department of Veterans Affairs National Acquisition Center (VANAC) as a quality assurance measurement. Offerors of Nutritional/Dietary Supplements will be required to adhere to published FDA GMP standards after January 1, 2008.

3. 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 4 of this clause.

4. 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 days 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 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).