Solicitation.doc

PAGE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

2009-N-11074

6. SOLICITATION

ISSUE DATE

02/11/2009

Berta Biltz

b. TELEPHONE NUMBER (No collect calls)

(770) 488-2643

8. OFFER DUE DATE/

LOCAL TIME

3/02/2009

12. DISCOUNT TERMS

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Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Branch B

2920 Brandywine Road

Atlanta, GA 30341-5539

X UNRESTRICTED

SIC:

SIZE STANDARD:

X SEE SCHEDULE

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

X

IFB

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RFQ

RFP

Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Branch B

2920 Brandywine Road

Atlanta, GA 30341-5539

CODE

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

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

“See Continuation Page”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

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

28.

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

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)

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

In accordance with Statement of Work in Section C below, the Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD) requires the award of one of more indefinite quantity, indefinite delivery contracts for the purchase of the following standard commercial vaccines manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration:

Diphtheria and Tetanus Toxoid with Acellular Pertussis Adsorbed (DTaP)

Minimum Shelf Life: 12 months

Maximum Quantity: 11 Million Doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $2.25 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Vial/Package Size:_______________

NDC Number: __________________

Diphtheria and Tetanus Toxoid with Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), and Poliovirus Vaccine Combined (DTaP/Hep B/IPV)

Minimum Shelf Life: 12 months

Maximum Quantity: 7,150,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $3.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Diphtheria and Tetanus Toxoid with Acellular Pertussis combined with Haeophilus Influenza Type b (DTaP/Hib)

Minimum Shelf Life: 12 months

Maximum Quantity: 220,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $3.00 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Diphtheria and Tetanus Toxoid with Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP/IPV)

Minimum Shelf Life: 12 months

Maximum Quantity: 2,200,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $3.00 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Diphtheria and Tetanus Toxoid with Acellular Pertussis Adsorbed, Inactivated Poliovirus, and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined

Minimum Shelf Life: 12 months

Maximum Quantity: 6,600,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $3.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Enhanced Inactivated Poliovirus (E-IPV)

Minimum Shelf Life: 12 months

Guaranteed Minimum: 100 doses

Maximum Quantity: 3,300,000 doses

Federal Excise Tax: $.075 per dose

Product Information:

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 13,200,000 Guaranteed Minimum: 100 doses

Cost: $13.13 per dose

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 110,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $1.50 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 6,600,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Hepatitis B (2-dose Regimen for Adolescents Ages 11-15 only)

Minimum Shelf Life: 12 months

Maximum Quantity: 220,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Hepatitis B combined with Haemophilus Influenza Type b (Hep B/Hib)

Minimum Shelf Life: 12 months

Maximum Quantity: 2,200,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $1.50 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Haemophilis Influenza Type b (Hib)

Minimum Shelf Life: 12 months

Maximum Quantity: 11M doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Quadrivalent Humap Papillomavirus Types 6, 11, 16 and 18 Recombinant vaccine (HPV)

Minimum Shelf Life: 12 months

Maximum Quantity: 7,150,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Measles, Mumps, Rubella (MMR)

Minimum Shelf Life: 12 months

Maximum Quantity: 7,700,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $2.25 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Measles, Mumps, Rubella and Varicell Combination (MMR-V)

Minimum Shelf Life: 12 months

Maximum Quantity: 4,400,000 doses

Guaranteed Minimum: 100 doses

Cost: $83.17 per dose

Federal Excise Tax: $3.00 per dose

Product Information:

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Meningococcal Conjugate (MCV4)

Minimum Shelf Life: 12 months

Minimum Order Size: 10 doses

Maximum Quantity: 5,500,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 13,200,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 7,700,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Tetanus and Diphtheria (Td)

Minimum Shelf Life: 12 months

Maximum Quantity: 1,100,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $1.50 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Tetanus Toxoid, Reduced Diphtheria Toxoid with Acellular Pertussis Adsorbed (Tdap)

Minimum Shelf Life: 12 months

Maximum Quantity 7,700,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $2.25 per dose

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Maximum Quantity: 7.7 M doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: $0.75 per dose

Product Information:

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Minimum Shelf Life: 12 months

Minimum Quantity: 110,000 doses

Guaranteed Minimum: 100 doses

Federal Excise Tax: N/A

Product Information:

Proposed Brand:________________

Proposed Min. order size :_______________

Total

Notes:

B.1 The vaccines awarded under these contracts will be purchased by the NCIRD 64 immunization grantees (the fifty state health departments, several large city programs and current and former U.S. Territories) as provided under Omnibus Budget Reconciliation Act of 1993 and Section 317(j) of the Public Health Service Act. Grantees may also purchase these vaccines using their own state funds. Vaccine will be ordered through the NCIRD electronic ordering system.

B.2. The period of performance shall be as follows: from date of award through March 31, 2010.

B.3. This will be a firm-fixed price, Indefinite delivery, indefinite quantity contract for standard commercial vaccines described herein, manufactured under a current establishment and product license issued by the US Food and Drug Administration (FDA) and as otherwise set forth herein.

SECTION C - CONTRACT CLAUSES

C.1.1.

Shelf Life

Vaccine provided under this contract shall have a minimum shelf life of 12 months remaining upon delivery to the consignee.

C.1.2.

Packaging and Packing Requirements a.

Packaging:

(1) All items shall be packaged in standard commercial manner.

(2) Pre-filled syringes shall not have fixed needles.

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 April 1, 2009 or date of award, whichever is later, through March 31, 2010.

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 pediatric vaccines F.O.B. Destination as directed by delivery orders to the designated CDC centralized distribution centers in Sacramento, CA and Memphis, TN.

b. The Contractor shall be required to deliver direct ship vaccines F.O.B. Destination, as directed by delivery orders to providers.

C.1.6.

Amendment to OBRA Statute

In the event of an amendment to 42 U.S.C. Section 1396 (s), any terms of this contracts affected by such an amendment will be modified in accordance with the revised statute. The Contracting Officer and the Contractor shall meet to discuss such modifications to the contract before finalization of any changes to the contract.

C.1.7.

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, biologicals, 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.1.8.

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 and State agencies as authorized. Orders may be placed by CDC by telephone (confirmed in writing) or by electronic transfer.

b. Optional Funding – Other Authorized Federal and State Agencies

(1) Other Federal and State agencies wishing to order vaccines against this contract must receive written authorization from the Contracting Officer. A list of authorized users shall be provided to the Contractor.

(2) Upon receipt of authorization, other Federal and State agencies may place orders against this contract. Contractors shall honor all authorized optional funding orders.

c.

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.1.9.

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 (CLIN) (See 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 Continuation of SF 1449) are the maximum number of doses that may be ordered on a monthly basis under the contract, not to exceed the total maximum estimated quantity stated for each CLIN.

c. Delivery Order shipments:

(1) The Government shall not be obligated to purchase doses that exceed the delivery order requirements. The Contractor shall be obligated for cost associated with the return of excess doses.

(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.1.10.

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.1.11.

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.1.12.

Contractor’s Ordering/Payment Address

Submission of orders and payment of invoices should be addressed as indicated below:

ORDERING ADDRESS

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.

(2) State and Local Agencies: The Contractor shall submit original and 3 copies of its invoice(s) to the address specified on the delivery order.

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;

(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) Expiration date of vaccine vials shipped;

(9) CDC accounting and appropriation data as described on the delivery order.

(10) Taxpayer I.D. Number; and

(11) DUNS Number C.1.14.

Method of Payment

Payments under this contract will be made as follows:

(1) CDC and Other Authorized Federal Agencies. The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(2) State Agencies: By check

C.1.15.

Payments by Other Authorized Federal Agencies and State Agencies

All other Federal agencies and State 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.1.8).

C.1.16.

Duty to Warn a.

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 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).

b.

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 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.

c.

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). 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.1.17.

Project Officer

Deberal Denson 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 Government agencies (Federal and State) 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.1.18.

Return Privileges

Return privilege 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.

C.1.19.

Restrictions on Use of Vaccines

Vaccines obtained under this contract shall be used only as authorized under Section 1928 of the Social Security Act. Sale of such vaccine to any person or entity is strictly prohibited. Free distribution of such vaccine is also prohibited, except as otherwise provided by Federal law.

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 manufacturer receiving a written summary of events leading to the request for credit or refund. All undistributed vaccine shall be returned 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 for 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

The credit memo shall clearly identify the CDC tracking number found on the original request for FET credit. If a credit or refund is issued by the Contractor for state or local accounts, the credit shall be submitted to the state or local public health entity identified in the written request for FET credit.

C.1.21.

Price Revisions

The contractor shall be allowed to revise the unit price for each CLIN either upward or downward, effective on August 1, 2009 and December 1, 2009 provided that the revised price does not exceed the contract price established at the initial award of the contract. The contractor shall also, at these times, be allowed to revise proposed maximum quantities for each CLIN and add additional package sizes. Proposals for revisions shall be submitted by the contractor no later than 15 calendar days prior to the dates listed above. The CDC will accomplish these changes to the unit prices by issuing bilateral modifications to the contract(s).

C.1.22.

New Vaccine Products

The following delineates the general approach to adding new vaccine products to the contract:

a. Manufacturers who receive a new FDA product license for a vaccine already included within the scope of a VFC resolution may, upon written request, have the new product added to its contract by modification at the price revision intervals stated in Terms and Conditions, Paragraph C.1.22., Price Revisions. Such new products must be consistent with VFC formulary schedules (regarding periodicity and dosage regimens) as established for the vaccine by CDC’s Advisory Committee on Immunization Practices (ACIP). Requests for addition of such products must be submitted to the Contracting Officer 30 days prior to the price revision interval dates.

b. When new vaccine products are approved by the ACIP for inclusion in the VFC formulary, CDC will issue a separate solicitation for obtaining such products. This would include a totally new vaccine or new combination of vaccines, new indications or new formulations for existing products or new dosing regimens for an existing product. Provided negotiations result in receipt of reasonable prices, CDC may, at its option, award separate contracts for these new products or add the products by modification to contracts awarded as a result of solicitation number.

C.1.23. Use of VFC Provider Lists and Distribution of Material

a. Contractors are prohibited from utilizing VFC provider lists obtained from any source for any mailing or other communication with VFC providers, except as approved in writing by the CDC Project Officer. In addition, contractors are prohibited from otherwise communicating with VFC providers regarding the VFC program, except as approved in writing by the CDC Project Officer. To the extent that contractors have established relationships with VFC providers or authorized purchasers under this contract that are independent from the VFC program, communications related to such independent relationships are not covered by this provision and do not require CDC consent.

b. Contractors are prohibited from providing names and/or addresses of VFC providers to any third party, except as needed to comply with the terms of this contract, in which case the CDC Project Officer shall be notified in writing of such use.

c. Any contractor that ships vaccine directly to VFC providers is prohibited from inserting any promotional or other material that is promotional in nature for any product that the contractor produces, into shipping containers for vaccine purchased under this contract, except for material related to use of the vaccine as approved in writing by the CDC Project Officer. Additionally any shipping container inserts that are required such as handling instructions or educational materials should not contain any promotional material as part of its content.

C.1.24. 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. This 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. The CDC agrees to work with the Contractor in good faith to allow the Contractor to remedy the effect of any supply shortage on contract performance, even if the contract performance is not specifically relieved by FAR 52.212-4(f).

C.1.25. Biological Surveillance Data Reports a.

Monthly Reports

Contractors shall submit a monthly reporting of historical distribution data for the United States by month 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 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 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.

b.

Data Reports to Manufacturers

The CDC shall submit monthly reports of all VFC vaccine data specifying doses by project, zip code, and NDC number in a standardized format. For all vaccines except direct ship vaccines, CDC will provide distribution data. Because CDC does not distribute direct ship vaccines, purchase data will be provided. Funding data will be provided at the grantee level and based on the grantees approved spend plan. The reports shall be submitted electronically to the Contractor by the 15th of the 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.1.26.

Prohibitions on Inducements

The Contractor is expressly prohibited from offering, providing or arranging inducements of any kind to VFC providers or authorized purchasers ordering vaccine under this contract for the purpose of obtaining orders for VFC 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.1.27.

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.1.28.

Advance Notice of Supply Issues

The Contractor agrees to provide advance notification to CDC/NIP of any supply issue which will result in the Contractor’s failure to deliver vaccine within the fifteen working day requirement specified in the contract. This notification shall be given as soon as the Contractor becomes aware of the scope of the problem that will impede the timely delivery of vaccine.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

E.6 FAR 52.212-5

Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Dec 2008)

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

(2) 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.]

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(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).

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(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)).

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

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

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(5) [Reserved]

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

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

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

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

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

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

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

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

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

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

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(10) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

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(11) 52.219-16, Liquidated Damages – Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

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(12)(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).

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

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(13) 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).

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(14) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

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(15) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 637f).

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(16) 52.219-28, Post Award Small Business Program Representation (June 2007) (15 U.S.C. 632(a)(2)).

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(17) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

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(18) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2008) (E.O. 13126).

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(19) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

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(20) 52.222-26, Equal Opportunity (Apr 2002) (E.O. 11246).

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(21) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

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(22) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

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(23) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

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(24) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

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(25)(i) 52.222-50, Combating Trafficking in Persons (Aug 2007) (Applies to all contracts).

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(ii) Alternate I (Aug 2007) of 52.222-50.

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(26)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)).

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(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

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(27) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

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(28)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products

(Dec 2007) (E.O. 13423).

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

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(29) 52.225-1, Buy American Act—Supplies (June 2003) (41 U.S.C. 10a-10d).

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(30)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (AUG 2007) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L 108-77, 108-78, 108-286, 109-53 and 109-169).

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

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

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(31) 52.225-5, Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

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(32) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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(33) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

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(34) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

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(35) 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)).

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(36) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

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(37) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

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(38) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

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(39) 52.232-36, Payment by Third Party (May 1999) (31 U.S.C. 3332).

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(40) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

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(41)(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).

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(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.]

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

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(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.).

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(3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Nov 2006) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

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(4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Feb 2002) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

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(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.).

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(6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

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(7) 52.237-11, Accepting and Dispensing of $1 Coin (Aug 2007) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) 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 paragraphs (e)(1)(i) through (xi) of this paragraph 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) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

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

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

(vi) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

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

(viii) 52.222-50, Combating Trafficking in Persons (AUG 2007) (22 U.S.C. 7104(g)). Flow down is required in accordance with paragraph (f) of FAR clause 52.222-50.

(ix) 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.).

(x) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(xi) 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). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

E.7 FAR 52.212-5

Alternate I Contract Terms and Conditions Required to Implement Statutes or Executive Orders –

Commercial Items - Alternate I (Feb 2000)

As prescribed in 12.301(b)(4), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause”.

(End of Alternate)

E.2 FAR 52.212-3 Offeror Representations and Certifications An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.

(End of Clause)

D.3. FAR 52.225-6 Trade Agreements Certificate (Jan 2005)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled “Trade Agreements.”

(b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products.

Other End Products:

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of Part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American Act. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation.

(End of Clause)

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.212‑1 as incorporated by reference in Block 27 of the Standard Form 1449, includes the following addendum:

E.1.1.

Paragraph ( c) of 52.212-1, Period for acceptance of offers, is deleted in its entirety and the following is substituted therefore:

( c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

E.1.2.

Paragraph (h.) of 52.212-1, Multiple awards, is deleted in its entirety and the following is substituted therefore:

Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

E.1.3.

FAR 52.233-2 Service of Protest (AUG 1996)

a. Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with the agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Centers for Disease Control & Prevention

Attn: Berta Biltz

2920 Brandywine Road, Room 3000

Atlanta, GA 30341-5539

b. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

E.1.5.

INSTRUCTIONS FOR SUBMISSION OF OFFERS:

a. Offerors shall submit their offers on the basis of Firm-Fixed Price by Midnight March 02, 2009.

b. Offers shall be submitted electronically (via e-mail) in MS Word or MS Excel files to Bbiltz@cdc.gov. The following format is required as e-mail subject: The RFP No: 2009-N-11074.KT.doc or xls (Where “2009-N-11074” is the respective RFP No. and “KT” are the first two letters of the respective Contractor's name; and “.doc” and “.xls” are the format extensions.)

c.

In the event there are…