Request for Proposal 2010-N-11987

PAGE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

00HCVGBC-2010-81768

PAGE 1 OF

2. CONTRACT NO.

TBD

3. AWARD/EFFECTIVE

DATE

TBD

4. ORDER NUMBER

5. SOLICITATION NUMBER

2010-N-11987

6. SOLICITATION

ISSUE DATE

4/09/2010

Russell T. Oxford

b. TELEPHONE NUMBER (No collect calls)

(770)-488-2082

8. OFFER DUE DATE/

LOCAL TIME

5/07/2010

12. DISCOUNT TERMS

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Centers for Disease Control and Prevention (CDC)

PROCUREMENT & GRANTS OFFICE (PGO), Branch II 2920 Brandywine Rd, M/S K-14

Atlanta, GA 30341-5539

X UNRESTRICTED

SET ASIDE:

NAICS: 325412

SIZE STANDARD: 750(employed)

X SEE SCHEDULE

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

X

IFB

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RFQ

RFP

To be shown on individual delivery orders

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Centers for Disease Control and Prevention (CDC)

PROCUREMENT & GRANTS OFFICE (PGO), Branch II

2920 Brandywine Rd, M/S K-14

CODE

Centers for Disease Control and Prevention

FINANCIAL MANAGEMENT OFFICE(FMO)

PO Box 15580 Atlanta, GA 30329-4018

TELEPHONE NO.

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

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

RECOVERY – 2010 Adult Vaccines Contract “See Continuation Page”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

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

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3, 52.212-2 AND 52.212-5 ARE ATTACHED. ADDENDA

X ARE

28.

X

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

29.

AWARD OF CONTRACT: REFERENCE

DATED

30b. NAME AND TITLE OF SIGNER (Type or print)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (Type or print)

Nancy M. Norton 31c. DATE SIGNED

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RECEIVED

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION

SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

TABLE OF CONTENTS

SECTION B - CONTINUATION OF SF1449tc \l2 "CONTINUATION OF SF 1449

SOLICITATION FOR ADULT VACCINES

The Centers for Disease Control and Prevention (CDC) is soliciting offers for the adult vaccines listed herein. Proposals must be received via email or postal mail no later than 4:00 PM Eastern Standard Time (EST) on Friday, May 7, 2010. Please reference the Solicitation Number 2009-N-11987 in the email subject line. Please email proposals to roxford@cdc.gov. Please mail proposals to the address as annotated in block 9 of Standard Form 1449 (See Page 1 of this solicitation). Facsimile and Telephone inquiries / quotes / proposals ‘will not’ be accepted. See Section E for further instructions.

CONTRACT TYPE and METHOD:

CDC intends to award multiple contracts under an Indefinite Delivery, Indefinite Quantity (IDIQ), and Firm Fixed Price (FFP) contracting vehicle. Orders may be placed with any of the multiple award contracts when a vaccine is available from more than one vendor. Delivery orders processed against this multiple award IDIQ contract are not competed among the various awardees / contractors, in that ordering decisions will be at the discretion of the purchaser.

This acquisition is made in accordance with the U.S. Federal Acquisition Regulation (FAR) Part 12, in conjunction with FAR Part 15. This multiple award IDIQ contract may include some or all vaccines listed herein. The vaccines to be purchased under the auspice of this contracting vehicle shall be standard commercial vaccines that are manufactured under current establishment and product licenses issued by the U.S. Food and Drug Administration (FDA) and as otherwise set forth herein.

GUARANTEED MINIMUM:

Each contract awarded under this solicitation shall have a guaranteed minimum quantity of 100 doses for each solicited vaccine.

The U.S. Government guarantees that the ‘minimum’ vaccine doses specified in each contract line item will be purchased during the contract term. In the event that the Contractor receives obligations of less than this minimum, the Government will reimburse the Contractor for the difference between the actual obligations and the guaranteed minimum.

MAXIMUM CONTRACT QUANTITY:

The Offeror guarantees that the ‘maximum’ vaccine doses specified in each contract line item will be available for purchase during the contract term.

NAICS CODE:

The North American Industry Classification System (NAICS) Code and Size Standard is established as: 325412 – Pharmaceutical Preparation Manufacturing. Size Standard (Number of Employees) = 750.

See U.S. Small Business Administration (SBA) table of size standards at: http://www.sba.gov/contractingopportunities/officials/size/index.html

CONTINUATION OF SF 1449

Contract Line

Item No. (CLIN) Vaccine Description

Hepatitis A Adult Vaccine

Maximum Estimated Quantity:

250,000 Doses

Guaranteed Minimum: 100 Doses

Product Requirements:

Minimum Shelf Life:

12 Months

Minimum Order Size:

100 Doses Per Destination

Federal Excise Tax:

$0.75 Per Dose

Size Restrictions:

Not to exceed 10 doses per vial or 25 vials/syringes per package.

Proposal Information:

Product/Brand Name:

Proposed Quantities

Total Maximum:

Monthly Maximum:

Vial/Package Size:

Unit Price (Excluding

Federal Excise Tax):

Price Per Dose:

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN)

Hepatitis B Adult Vaccine

500,000 Doses

300 Doses Per Destination

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN)

Hepatitis A & B Combination Adult Vaccine

350,000 Doses

300 Doses Per Destination

$1.50 Per Dose

NDC Number:

Federal ExciseTax):

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN)

Pneumococcal Polysaccharide Adult Vaccine

20 Doses Per Destination

Not Applicable

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN)

Tetanus and Diphtheria Toxoids Adult Vaccine

100,000 Doses

$1.50 Per Dose

Monthly Maximum

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN)

Herpes Zoster Adult Vaccine

Not Applicable

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN) Vaccine Description

Tetanus, Reduced Diphtheria Toxoids, and Acellular Pertussis (Tdap) Adult Vaccine

1,000,000 Doses

$2.25 Per Dose

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN) Vaccine Description

Measles, Mumps, and Rubella (MMR)

200,000 Doses

$2.25 Per Dose

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN) Vaccine Description

Meningococcal Conjugate (Groups A,C,Y & W)

100 Doses Per Destination

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN) Vaccine Description

Human Papillomavirus

300,000 Doses

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

Contract Line

Item No. (CLIN) Vaccine Description

Varicella

100,000 Doses

In the space below or on a separate page, the offeror shall enter the following information for all package options offered: Vial/Package Size, NDC Number and Unit Price (excluding Federal Excise Tax):

SECTION C - CONTRACT CLAUSES

C.1 FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS, March 2009, as incorporated by reference in Block 27 of the Standard Form 1449, includes the following addendum:

C.1.1.

Shelf Life

Vaccine provided under this contract shall have a minimum 12 month shelf life remaining upon delivery to the consignee, as specified within each Contract Line Item Number (See Section B, Continuation of SF 1449).

C.1.2.

Packaging and Packing Requirements a.

Packaging:

All items shall be packaged in standard commercial manner.

b.

Packing:

Product shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. Freeze watch indicators or their equivalent are required with each shipment.

C.1.3.

Contract Period of Performance The contract period of performance shall begin on July 1, 2010 or date of award, whichever is later, and shall end on June 30, 2011.

C.1.4.

Time of Delivery Delivery is required to be made at destination within 15 working days after receipt of electronic, written or telephonic order (telephone orders to be confirmed in writing).

C.1.5.

Place of Delivery – F.O.B. Destination

a. The Contractor shall be required to deliver vaccines F.O.B. Destination, as directed by delivery orders to the CDC centralized distribution locations in Sacramento, CA and Memphis, TN. Ship To / Ship For address shall be specified per delivery order.

b. The Contractor shall be required to deliver frozen vaccines F.O.B. Destination as directed by delivery orders.

C.1.6.

Product Licensure

a. The vaccines produced and delivered under this contract shall be manufactured under a current establishment and product license issued by the Food and Drug Administration as indicated below:

b. The Current Good Manufacturing Practice Regulations (CGMPR’s) (21CFR Parts 210‑211) will be the standard to be applied for manufacturing, processing and packing of drugs, chemicals, biological, and reagents.

c. The Contractor shall advise the Contracting Officer immediately of any relocation of his prime manufacturing facility or the relocation of any subcontractor’s facility, and if at any time during the life of the contract, the item listed under this contract fails to meet CGMPR’s and/or a negative Food and Drug Administration Quality Assurance Evaluation is received, the contract may be terminated, in whole or in part, without further liability to the Government.

C.1.7.

Placement of Orders

a. All vaccine under this contract will be ordered by delivery orders. Orders shall be placed by the Health and Human Services (HHS) Supply Service Center, the Centers for Disease Control and Prevention (CDC); or other Federal Agencies as authorized. Orders may be placed by CDC by telephone (confirmed in writing) or by electronic transfer.

b. Orders shall be submitted to the Ordering Address specified in Contract Clauses Paragraph C.1.12; Contractor’s Ordering/Payment Address and shall contain the following minimum information:

1. Date of order;

2. Contract number and order number;

3. Item description, quantity and unit price;

4. Delivery or performance date;

5. Place of delivery or performance (including consignee);

6. Packaging, packing and shipping instructions, if any;

7. Accounting and appropriation data;

8. Statement to indicate if partial deliveries are not acceptable; (Lack of a statement shall be construed to mean partial deliveries are acceptable and payment shall be made as required elsewhere herein)

9. Any other pertinent data.

C.1.8.

Delivery Order Limitations

a. Minimum Order Size: Individual delivery orders issued under this contract must meet the minimum order size as specified within each Contract Line Item Number (See Section B, Continuation of SF 1449). When the Government requires supplies covered by this contract in amounts less than stated above, the Government is not obligated to purchase, nor is the Contractor obligated to furnish those supplies under this contract.

b. Maximum Order: The maximum monthly quantity specified within each Contract Line Item Number (See Section B, Continuation of SF1449) is the maximum number of doses that may be ordered on a monthly basis under the contract, not to exceed the total maximum estimated quantity. This includes orders from the HHS Supply Service Center and other users.

c. Delivery Order Shipments:

(1) The Government reserves the right to reject vaccine doses that exceed delivery order requirements. The Government shall notify the Contractor when excess doses have been delivered to designated site as directed by the delivery order. The Contractor shall be responsible for contacting the designated site to make arrangements for the return of excess doses and shall be responsible for shipping costs associated with their return.

(2) Bulk order shipments, when possible, shall consist of i.

one NDC per skid ii.

full skid with same lot number iii.

full case (when total order size allows)

C.1.9.

FAR 52.216-18 ORDERING (OCT 1995)

a. Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the effective date of the contract through the expiration date of the contract.

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

c. If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally or by written telecommunications only if authorized in the Schedule.

C.1.10.

FAR 52.216‑22 INDEFINITE QUANTITY (OCT 1995)

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

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

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

d. Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after fifteen (15) working days beyond the expiration date of the contract.

C.1.11.

Report of Orders

a. The Contractor shall provide monthly reports of all vaccine purchased under this contract by ordering offices other than CDC. The report shall be submitted within 30 days following the end of the month and shall contain the following information:

Name of Purchaser:

Number of Doses Purchased:

Lot Number:

b. Reports shall be forwarded to the designated Project Officer with a copy to the Contracting Officer.

C.1.12.

Contractor’s Ordering/Payment Address Submission of all orders for Contractor’s vaccines and payment of invoices shall be addressed as referenced below:

ORDERING ADRESS

PAYMENT ADDRESS

C.1.13.

Invoice Submission

a. Invoice submission under this contract will be made as follows:

1. HHS Supply Service Center, CDC and Other Authorized Federal Agencies: The Contractor shall submit invoices via Electronic Data Interchange (EDI) in a format to be mutually agreed upon between CDC and the Contractor.

b.

The Contractor agrees to include the following information on each invoice:

1. Contractor’s name and invoice date;

2. Contract number, or other authorization for delivery of property and/or services;

3. Description, cost or price, and quantity of property and/or services actually delivered or rendered;

4. Shipping and payment terms;

5. Other substantiating documentation or information as required by the contract; and

6. Name where practicable, title, phone number, and complete mailing address of responsible official to whom payment is to be sent.

7. Lot number of vaccine vials shipped;

8. CDC accounting and appropriation data as described on the delivery order.

9. Contractor’s taxpayer identification number or employer identification number

(TIN or EIN)

10. Contractor’s DUNS Number C.1.14.

Method of Payment

a. Payments under this contract will be made as follows:

1.

CDC and Other Authorized Federal Agencies. By check or by wire transfer through the Treasury Financial Communications System at the option of the Government.

b. The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. The contractor is required to designate in writing a financial institution for receipt of electronic funds transfer payments. The Contractor shall forward the following information in writing to Centers for Disease Control and Prevention, Attn: Financial Management Office, Atlanta, GA 30333, not later than seven days after receipt of notice of award:

1. Full name (where practicable), title, phone number, and complete mailing address of responsible official(s) to whom check payments are to be sent, and who may be contacted concerning the bank account information requested below.

2. The following bank account information required to accomplish wire transfers: (i) Name, address, and telegraphic abbreviation of the receiving financial institution; (ii) receiving financial institution’s nine digit American Bankers Association (ABA) identifying number for routing transfer of funds. (Provide this number only if the receiving financial institution has access to the Federal Reserve Communications System.) (iii) Recipient’s name and account number at the receiving financial institution to be credited with the funds. (iv) If the receiving financial institution does not have access to the Federal Reserve Communications System, provide the name of the correspondent financial institution through which the receiving financial institution receives electronic funds transfer messages. If a correspondent financial institution is specified, also provide the address and telegraphic abbreviation of the correspondent financial institution, and the correspondent financial institution’s nine digit ABA identifying number for routing transfer of funds.

3. Any changes to the information furnished under paragraph (b) of this clause shall be furnished to Centers for Disease Control and Prevention, Attn: Financial Management Office, Atlanta, GA 30333 in writing at least 30 days before the effective date of the change. It is the Contractor’s responsibility to furnish these changes promptly to avoid payments to erroneous addresses or bank accounts.

C.1.15.

Payments by Other Authorized Federal Agencies

All other Federal agencies authorized to order vaccine using optional funding shall be required to comply with all terms and conditions hereunder, including the Prompt Payment Act and all payment provisions required by Paragraph’s C.1.12, C.1.13 and C.1.14 above. All payment provisions are applicable to all partial deliveries accepted by the ordering office. Ordering offices are responsible for advising the Contractor if partial deliveries are not acceptable before shipment (reference Paragraph C.1.7).

C.1.16. Project Officer

_________________ (To Be Determined) ; has been designated in writing by the Contracting Officer to serve as Project Officer during the period of performance of the contract. The Project Officer shall be responsible for guidance in regard to the technical aspect of the contract, provide a point for liaison between the Contractor and other Federal Agencies and be the general focal point to address technical and logistical problems relating to the performance under the contract. The Project Officer shall not have the authority to make any commitments or authorize any changes which affect the contract price, terms and/or conditions; any such changes shall be referred to the Contracting Officer for action.

C.1.17.

Duty To Warn The Department of Health and Human Services (HHS), HHS Supply Service Center, Centers for Disease Control and Prevention (CDC), and other HHS, Federal and State agencies as authorized, hereinafter referred to as the Government, represent and agree that all programs which are supplied vaccine under this contract shall take appropriate steps to assure that such vaccine is administered in compliance with Section 2126 of the Public Health Service Act (42 U.S.C. 300aa-26).

a. If any claim or action is asserted against the Contractor arising in whole or in part from an alleged failure by the Government, to carry out its responsibilities under paragraph (a) above, the Contractor shall promptly notify the Contracting Officer and furnish to him copies of all pertinent documents served upon or received by the Contractor. The Government shall provide reasonable assistance and full cooperation including, but not limited to, making witnesses available to testify and providing relevant documents to the Contractor to assist the Contractor in defending any claims arising from the Government’s alleged failure to carry out its responsibilities under paragraph (a) above. The Government shall have the option to participate in the defense of that portion of such claim or action which arises from the alleged failure of the Government to carry out its responsibilities under paragraph (a) above.

b. In the event of the Government’s breach of, or failure to carry out, its responsibilities under paragraph (a) above, any measure of resulting damages to the Contractor shall include, but need not be limited to, damages (including money judgments, reasonable attorneys’ fees, and other costs) sustained in connection with claims against the Contractor for personal injuries caused by such breach or failure. The Contractor agrees to take appropriate steps to mitigate any such claims by diligently defending claims brought against it or, when appropriate, by entering into reasonable settlement agreements. The entry of a judgment against the Contractor in connection with a claim for personal injury allegedly resulting in whole or in part from the Government’s breach of, or failure to carry out, its obligations under paragraph (a) shall not conclusively determine the question whether the personal injury complained of or the damages suffered by the Contractor were caused by the Government’s breach of or failure to carry its obligations under paragraph (a). This provision shall not limit any other right of the Contractor to obtain damages or other relief for any breach of this contract or for the settlement of any dispute arising under this contract.

C.1.18. Return Privileges

Return privileges for credit, reimbursement or exchange do not apply to this contract except vaccines not conforming to the specifications set forth herein, which are limited to credit or exchange only.

C.1.19.

Restrictions on Use of Vaccines

Vaccines obtained under this contract shall be used solely for purposes of Federal agencies and State immunization programs. Sale of such vaccine to any person or entity is strictly prohibited. Free distribution of such vaccine is also prohibited, except where such vaccine is administered in the context of Federal agencies and State immunization program activities.

C.1.20.

Federal Excise Tax Credit Negotiated prices for the vaccines included in this Contract may include a Federal Excise Tax (See Continuation of SF 1449 for applicable Contract Line Item Numbers). If for any reason the vaccine is returned (other than for resale) or destroyed, the Contractor shall within 6 months following the date the vaccine is returned or destroyed, file a claim for credit or refund relative to any tax previously paid on such vaccine. The Contractor agrees to credit or refund the amount of such excise tax to the purchaser to the extent that the Contractor receives a credit or refund from the Federal Government. Any such credit or refund to the purchaser is expressly conditioned upon the authorized purchaser providing a written summary of events leading to the request for credit or refund. The purchaser shall return all undistributed vaccine to the manufacturer for proper disposal, unless destruction of the vaccine renders return impossible. If destruction of the vaccine renders return impossible and is therefore destroyed by the purchaser, the authorized purchaser must provide a written summary of events to the manufacturer within 30 days of said destruction. If a contract is in place with the Contractor at the time when a credit or refund is due, the purchaser may elect to receive vaccine which will be purchased at the current contract price in lieu of a cash payment. Otherwise, the Contractor shall refund the amount due to the purchaser’s account. If a credit or refund is issued by the Contractor to the CDC VFC or 317 Fund account, a credit memo shall be submitted to:

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Immunization Services Division

Vaccine Supply and Assurance Branch

Mailstop E-52, Attn: Deberal Denson

1600 Clifton Road

Atlanta, GA 30333

C.1.21 Delinquent Delivery Reports

The Contractor shall provide CDC with a weekly electronic listing of all CDC orders that have not been shipped within the 15 working day requirement. The report shall include the following information: project name, order number, date of order, and status of order in number of pending/undelivered doses. The report shall also provide an explanation as to the cause for the delinquent delivery as well as when the vaccine will be delivered. This notification shall not relieve the contractor from meeting its obligations under the contract and shall not limit the Government’s right to seek relief for any breach of contract for failure to perform, including termination for cause.

C.1.22 Biological Surveillance Data Reports

The Contractor shall submit a monthly report of historical distribution data for the United States by project specifying the name of the vaccine and the total number of doses sold (segregated by CDC and non-CDC sales), in a standardized format acceptable to the Contractor and the CDC. The report shall be submitted electronically to the Project Officer by the 15th of the month. Information related to vaccine sales through CDC contracts is not considered proprietary. CDC acknowledges that those reports pertaining to private sales unrelated to this contract are confidential and proprietary information of the Contractor, and shall not use reports for any purpose other than CDC’s internal tracking and reporting purposes and shall not further disclose such reports without the Contractor’s prior written consent unless required by the law or other Federal authority; provided that, no Contractor authorization shall be required for the CDC to include the data from the Contractor’s report in a report in which aggregated data from multiple manufacturers is summarized, so long as, with respect to multi-sourced products, the CDC’s aggregated report does not include any data which could be individually identified as the Contractor’s. In the event that CDC is required by law or other Federal authority to disclose such reports required to be held confidential hereunder, CDC shall notify the Contractor prior to making such disclosure in accordance with law or other Federal authority.

Data Reports to Manufacturers

The CDC shall submit monthly reports of vaccine data specifying doses by project, zip code, and NDC number in a standardized format. Funding data will be provided at the grantee level and based on provider orders by vaccine type and the grantee’s approved spend plan. The reports shall be submitted electronically to the Contractor by the 15th of each month for the previous month. CDC shall also provide the Contractor with an annual Vaccine Ordering Forecasting Application (VOFA) spend plan for each grantee as well as an annual VFC providers list.

C.1.23. Prohibitions on Inducements

The Contractor is expressly prohibited from offering, providing or arranging inducements of any kind to providers or authorized purchasers ordering vaccine under this contract for the purpose of obtaining orders for vaccine. Examples of such inducements include, but are not limited to: entertainment, meals, and free or reduced prices for syringes, vaccines, or other medical products or supplies.

C.1.24. Contract Changes

The Contracting Officer and the Contractor shall meet (electronic means acceptable) to discuss such modifications to the contract before finalization of any changes to the contract.

C. 1.25. Maximum Contract Price

The contract unit prices for CLIN 0001 through 0011 shall be no higher than the manufacturer’s current Federal Ceiling Price (FCP) as established by the manufacturer and the Department of Veterans Affairs. These FCPs are reviewed and recalculated annually and are normally established as an annual FCP on or about January 1st of each year. If during the contract period, the FCP for any vaccine is reduced to a price lower than the contract unit price, the Contractor shall in turn reduce the CDC’s contract unit price. The procedure for making such changes to the contract shall be as follows: (1) the Contractor shall notify the Contracting Officer within 10 business days of the effective date of the establishment of a FCP which is lower than the contract unit price; and (2) The Contracting Officer shall issue a bilateral modification upon receipt of this notification.

C.1.26. Authorized Distributor of Record (ADR)

I. Background

The Food and Drug Administrations’ (FDA) Prescription Drug Marketing Act (PDMA) (Public Law 100-293) was enacted on April 22, 1988, and was modified by the Prescription Drug Amendments (PDA) (Public Law 102-353, 106 Stat. 941) on August 26, 1992. The PDMA as modified by the PDA amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, 381) to, among other things, establish requirements for the wholesale distribution of prescription drugs. Section 503(e)(1)(A) of the act states that each person who is engaged in the wholesale distribution of a prescription drug who is not the manufacturer or an authorized distributor of record for the drug must, before each wholesale distribution of a drug, provide to the person receiving the drug a statement (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of the drug, including the date of the transaction and the names and addresses of all parties to the transaction. Section 503(e)(4)(A) of the act states that, for the purposes of section 503(e), the term “authorized distributors of record'' means those distributors with whom a manufacturer has established an ``ongoing relationship'' to distribute the manufacturer's products. On December 3, 1999, the agency published final regulations in part 203 (21 CFR part 203) implementing these and other provisions of PDMA

(64 FR 67720). Section 203.50 requires that, before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller must provide to the purchaser a statement identifying each prior sale, purchase, or trade of the drug. The identifying statement must include the proprietary and established name of the drug, its dosage, the container size, the number of containers, lot or control numbers of the drug being distributed, the business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer, and the date of each previous transaction. Section 203.3(b) defines ``authorized distributor of record'' as a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. ``Ongoing relationship'' is defined in 203.3(u) to mean an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments. If the distributor is not authorized to distribute a manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute. Thus, the final rule requires unauthorized distributors (i.e., those distributors who do not have a written authorization agreement) to provide a drug origin statement (pedigree) to purchasers showing the entire prior sales history of the drug back to the first sale by the manufacturer. As discussed in the preamble to the final rule (64 FR 67720 at 67747), manufacturers and authorized distributors of record are not required to provide an identifying statement when selling a drug, although the agency encouraged them to do so voluntarily to permit unauthorized distributors to continue to be able to purchase products from them.

II. In accordance with the PDMA, Offerors other than vaccine manufacturers (distributors) must provide a written statement that they are an Authorized Distributor of Record for all vaccines offered in their proposal.

III. In accordance with the PDMA, it is requested that all vaccine manufacturers provide a written statement, utilizing the provided sample, which designates the CDC as the Authorized Distributor of Record (ADR) for all vaccines subject to distribution under the auspice of the contract in question.

AUTHORIZED DISTRIBUTOR OF RECORD (ADR) AGREEMENT

This Agreement hereby represents the ongoing relationship between the manufacturer named below “SUPPLIER” and Centers for Disease Control and Prevention, herein after referred to as “CDC”, to establish and designate CDC as an Authorized Distributor of Record (ADR) as set forth in the Prescription Drug Marketing Act (PDMA) of 1988 as well as in the implementing federal regulations found at 21 CFR Part 203. CDC here after agrees to comply with all applicable state and federal laws to ensure continued status of this relationship. To further meet the requirements of the PDMA, please forward with the signed agreement an attachment with a list of the specific products that CDC is authorized to distribute or a statement that the wholesale distributor is an ADR for the manufacturer’s entire product line. Specific products should be identified by the pharmaceutical / vaccine name, dosage form, and strength of the drug and the NDC number.

Check the box that applies:

□ The CDC is the ADR for Supplier’s entire product line.

□ The CDC is the ADR for the products listed on the attachment.

This agreement shall be valid from the date of dual execution until termination by either party on ninety (90) days written notice. This agreement shall not abridge, supplant, modify, or in any way alter any other pre-existing distribution agreement or any future agreements that may, from time to time, be executed in the furtherance of the business relationship between Supplier and the CDC.

This agreement confers no rights upon CDC other than to designate CDC as an Authorized Distributor of Record for Supplier. This agreement is not intended to be, nor shall it be, interpreted as a sales agreement or any other type of agreement other than to represent an” ongoing relationship” within the meaning set forth in 21 CFR Part 203.3(u).

By affixing my signature below, I do hereby acknowledge and represent that I have read this Agreement in its entirety, that I understand its terms, that I am duly authorized to bind my organization to the requirements detailed in the above Agreement and that I agree to ensure that my organization will adhere to such requirement for the duration herein stated.

Authorized Distributor of Record: Centers for Disease Control and Prevention (CDC) Authorized Signature:________________________________________

Print Name: _____________________________________

Date:_________________

Supplier:_________________________________________________________

Authorized Signature:______________________________________________

Print Name: _____________________________________

Date: _______________

FAR SOURCE TITLE AND DATE

C.2 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. (Feb 2010) As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Feb 2010)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

X (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Mar 2009) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

X (4) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Mar 2009) (Pub. L. 111-5).

___ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a).

___ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jul 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (7) [Reserved]

___ (8) (i) 52.219-6, Notice of Total Small Business Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-6.

___ (iii) Alternate II (Mar 2004) of 52.219-6.

___ (9) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

X (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)).

X (11) (i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637 (d)(4).)

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

___ (13) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (14) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

___ (ii) Alternate I (June 2003) of 52.219-23.

___ (15) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (16) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f).

___ (18) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)).

X (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (20) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126).

X (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

X(22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

X (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212).

X (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

___ (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212).

X (26) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (27) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (29) (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

___ (ii) Alternate I (Dec 2007) of 52.223-16.

X (30) 52.225-1, Buy American Act--Supplies (Feb 2009) (41 U.S.C. 10a-10d).

___ (31) (i) 52.225-3, Buy American Act –Free Trade Agreements – Israeli Trade Act (Jun 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-301, 109-53, 109-169, 109-283, and 110-138).

___ (ii) Alternate I (Jan 2004) of 52.225-3.

___ (iii) Alternate II (Jan 2004) of 52.225-3.

___ (32) 52.225-5, Trade Agreements (Aug 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (33) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

___ (37) 52.232.30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

___ (38) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct. 2003) (31 U.S.C. 3332).

___ (39) 52.232-34, Payment by Electronic Funds Transfer—Other Than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

___ (40) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

___ (41) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (42) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

___ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C.206 and 41 U.S.C. 351, et seq.).

___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

___ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

___ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

___ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247).

___ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) [Reserved]

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793).

(vii) [Reserved]

(viii) 52.222-41, Service Contract Act of 1965, (Nov 2007), (41 U.S.C. 351, et seq.)

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to…