2009 FLU 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-10994

6. SOLICITATION

ISSUE DATE

Cherie J. Katin

b. TELEPHONE NUMBER (No collect calls)

(770) 488-2652

8. OFFER DUE DATE/

LOCAL TIME

12/19/2008

12. DISCOUNT TERMS

FORMTEXT

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

X SET ASIDE:

SIC: 325414

SIZE STANDARD:

X SEE SCHEDULE

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

X

IFB

FORMTEXT

RFQ

RFP

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

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

2009 Influenza Vaccines “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 AND 52.212-5 ARE ATTACHED. ADDENDA

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)

Nancy M. Norton 31c. DATE SIGNED

FORMTEXT

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 CONTINUATION OF SF1449tc \l2 "CONTINUATION OF SF 1449

BACKGROUND:

The Vaccine For Children (VFC) program, established pursuant to Section 13631 of the Omnibus Budget Reconciliation Act of 1993 (OBRA ‘93), guarantees federal support for the purchase and supply of sufficient quantities of vaccine to the States to cover a defined group of children. Children (18 years-of-age or younger) who qualify for immunization through the VFC purchase program include those who are (1) Medicaid-eligible, (2) without health insurance, (3) Indian (as defined in Subsection (h)(3) of OBRA ‘93), or (4) children with health insurance, which does not cover the cost of vaccines, if they receive their immunizations at a Federally-qualified health center or rural health clinic (as defined by the Social Security Act). Health care providers who agree to certain requirements are eligible through the States to receive free vaccine through this VFC purchase program. Purchases for childhood immunization programs under Section 317(j) of the Public Health Service Act are also included under these contracts. In addition, States may opt to purchase vaccine under any resulting contract for children not included in above categories by using their own funding mechanism. Such orders shall not be subject to refusal by the manufacturers.

DEFINITIONS:

OBRA ORDERS - Vaccine orders under Section 1928(a)(2)(A) of the Social Security Act.

OPTIONAL FUNDING - Vaccine orders under Section 1928(d)(4)(B) of the Social Security Act and orders placed by other Federal agencies and authorized immunization programs.

MANUFACTURER - As defined in Subsection (h)(4) of the Social Security Act, means any corporation, organization, or institution, whether public or private (including Federal, State and local departments, agencies, and instrumentalities), which manufacturers, imports, processes, or distributes under it’s label any pediatric vaccine.

STATE AGENCIES - Includes State health departments and certain local health agencies authorized to order hereunder.

317/DA GRANT ORDERS - Vaccine orders under Section 317(j) of the Public Health Service Act.

TYPE OF CONTRACT:

Indefinite delivery, indefinite quantity type contracts will be awarded for the standard commercial vaccine described herein, manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration (FDA) and as otherwise set forth herein.

CONTINUATION OF SF 1449tc \l2 "CONTINUATION OF SF 1449

Contract Line

Item No. (CLIN) Vaccine Description 0001 Pediatric Influenza Virus Vaccine (Ages 6-35 months)

Preservative Free which contains trace amounts of Thimerosal

Maximum Estimated Quantity:

5,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

300 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

Any vial size available, not to exceed 10 doses per vial

**pre-filled syringes shall not have fixed needles.** Proposal Information:

Product/Brand Name:

Proposed Quantities

Total Maximum:

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) Vaccine Description

Influenza Virus Vaccine (Pediatric thru Adult) (Age: 6 months and older)

Maximum Estimated Quantity:

6,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

300 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

Any vial size available, not to exceed 10 doses per vial

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

Influenza Virus Vaccine, (Pediatric thru Adult) (Age: 36 months and older)

3,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

300 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

Any vial size available, not to exceed 10 doses per vial

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

Influenza Virus Vaccine, (Pediatric thru Adult) (Age: 4 years and older)

Maximum Estimated Quantity:

3,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

300 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

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

Influenza Virus Vaccine, (Adult) (Age: 18 years and older)

3,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

300 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

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

Influenza Virus Vaccine – Live Intranasal –

Preservative Free (Age 2 – 49 years)

4,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

20 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

Any vial size available

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

Influenza Virus Vaccine, (Optional Product)

Contractor may use this CLIN to propose any vaccine pending FDA approval to be added to this contract as an optional product. This CLIN may be exercised at the discretion of the Government upon FDA approval.

Maximum Estimated Quantity:

(to be proposed) Doses

Guaranteed Minimum Quantity:

0 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2010 or later

Minimum Order Size:

30 Doses Per Destination

OBRA Ceiling Price:

Not Applicable

Federal Excise Tax:

$.75 Per Dose

Size Restriction:

Any vial size available, not to exceed 10 doses per vial

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, 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 an expiration date of June 30, 2010 or later.

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 the date of award, and shall end on February 28, 2010.

C.1.4.

Time of Delivery Offeror shall propose delivery schedule.

C.1 – Contract Clauses (Continued)

C.1.5.

Place of Delivery - F.O.B. Destination The Contractor shall be required to deliver influenza F.O.B. Destination, as directed by delivery orders to the designated CDC centralized distribution locations in Sacramento, California and Memphis, Tennessee.

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 contract 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 specified under each contract Line Item in Section B, (Continuation of SF 1449). When the Government requires supplies covered by this contract in amounts less than stated in the schedule, the Government is not obligated to purchase, nor is the Contractor obligated to furnish those supplies under this contract.

b.

Maximum Order: The Contractor must be capable of furnishing the total quantity shown for each CLIN (See, Continuation of SF 1449) in accordance with Paragraph C.1.4, Time of Delivery.

c. Delivery Order Shipments:

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

(2) Delivery order shipments, when possible, shall consist of:

i. one NDC per skid

ii. full skid quantities with same lot number iii full case quantities (when total order size allows)

iv. influenza vaccine only, except in the event of an emergency need to ship other vaccine products.

C.1 – Contract Clauses (Continued)

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.

a. 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 by electronic transfer, orally or by written telecommunications.

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 – Contract Clauses (Continued)

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 an 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; 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) Expiration date of vaccine vials shipped; and

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

(10) Taxpayer Identification number

(11) DUNS number

C.1 – Contract Clauses (Continued)

C.1.14 Method of Payment a.

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 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.1.17 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.1.18.

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 where such vaccine is administered in the context of Federal immunization program activities or otherwise provided by Federal law.

C.1.19 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 receipt of 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 to federal fund accounts, 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 identify CDC tracking number found on the original request for credit. The Contractor will issue credit to purchasers with state fund accounts.

C.1.20 Use of VFC Provider Lists and Distribution of Material

Any Contractor that ships vaccine directly to VFC providers is prohibited from inserting any promotional material 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. In addition, Contractors are prohibited from utilizing VFC provider lists for any mailing or other communication intended to promote use of particular vaccines or any other products, except as approved in writing by the CDC Project Officer. Contractors are prohibited from providing names and/or addresses of VFC providers to any third party, except as need to comply with the terms of this contract, in which case the CDC Project Officer shall be notified of such use.

C.1 – Contract Clauses (Continued) 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 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.

C.1.22 Biological Surveillance Data Reports

Contractors shall submit a monthly reporting of historical surveillance 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 standard format acceptable to CDC and the Contractor. The report shall be submitted electronically to the Project Officer by the 15th of each 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 such reports for any purpose other than CDC’s internal tracking and reporting pruposes and shall not futher disclose such reprots without the Contractor’s prior written consent unless requried 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 which aggregated data from multiple manufacturers is summarized, as 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 requried to be held confidential hereunder, CDC shall notify the Contractor prior to making such disclosure in accordance with law or other Federal authority.

C.1.23 Prohibitions on Inducements The Contractor is expressly prohibited from offering inducements of any kind to 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, free or reduced prices for syringes, vaccines, or other medical products or supplies.

C.1.24 Advance Notice of Supply Issues The Contractor agrees to provide advance notification to CDC/NCIRD 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.

C.1.25 Contract Changes

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

C.1 – Contract Clauses (Continued) C.1.26 Report of Orders

The Contractor shall provide monthly reports to the CDC Project Officer of all vaccines 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:

C.1.27 Price Revision The Contractor shall be allowed to revise the unit price for each CLIN effective on

August 1, 2009, provided that the revised price does not exceed the initial contract price. The Contractor shall also, at this time, be allowed to increase proposed maximum quantities for each CLIN. Requests for price revisions shall be submitted by the Contractor no later than 15 calendar days prior to the date listed above. The CDC will accomplish these changes to the unit prices by issuing bilateral modifications to the contract.

C.2 52.212‑5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders — Commercial Items (Jan 2005)

(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.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jul 1995), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

__ (2) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a).

__ (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 1999) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (4)(i) 52.219-5, Very Small Business Set-Aside (June 2003) (Pub. L. 103-403, section 304, Small Business Reauthorization and Amendments Act of 1994).

__ (ii) Alternate I (Mar 1999) of 52.219-5.

__ (iii) Alternate II (June 2003) of 52.219-5.

__ (5)(i) 52.219-6, Notice of Total Small Business Set-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.

__ (6)(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 (7) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)).

X (8)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2002) (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.

__ (9) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

__ (10)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (June 2003) (Pub. L. 103-355, section 7102, and 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.

__ (11) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Oct 1999) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (12) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (13) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004).

__ (14) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (15) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (June 2004) (E.O. 13126).

X (16) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

X (17) 52.222-26, Equal Opportunity (Apr 2002) (E.O. 11246).

X (18) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212).

X (19) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

X (20) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212).

__ (21) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

__ (22)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Aug 2000) (42 U.S.C. 6962(c)(3)(A)(ii)).

__ (ii) Alternate I (Aug 2000) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

__ (23) 52.225-1, Buy American Act-Supplies (June 2003) (41 U.S.C. 10a-10d).

__ (24)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (Jan 2005) (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).

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

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

X (25) 52.225-5, Trade Agreements (Jan 2005) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (26) 52.225-13, Restrictions on Certain Foreign Purchases (Dec 2003) (E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (27) 52.225-15, Sanctioned European Union Country End Products (Feb 2000) (E.O. 12849).

__ (28) 52.225-16, Sanctioned European Union Country Services (Feb 2000) (E.O. 12849).

__ (29) 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)).

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

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

__ (32) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (33) 52.232-36, Payment by Third Party (May 1999) (31 U.S.C. 3332).

__ (34) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (35)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Apr 2003) (46 U.S.C. Appx 1241 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, as Amended (May 1989) (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) (May 1989) (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 (Feb 2002) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (5) 52.222-47, SCA Minimum Wages and Fringe Benefits Applicable to Successor Contract Pursuant to Predecessor Contractor Collective Bargaining Agreements (CBA) (May 1989) (41 U.S.C. 351, et seq.).

(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 (i) through (vii) 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) 52.219-8, 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 $500,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212).

(iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

(vi) 52.222-41, Service Contract Act of 1965, as Amended (May 1989), flow down required for all subcontracts subject to the Service Contract Act of 1965 (41 U.S.C. 351, et seq.).

(vii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Apr 2003) (46 U.S.C. Appx 1241 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)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

There are no clauses/provisions included in this section.

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:

(h) 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.

Paragraph (k), incorporating FAR clause 52.215-5, Facsimile Proposals, is added as follows:

(k) 52.215-5 – Facsimile Proposals (OCT 1997)

(a) Definition. “Facsimile proposal,” as used in this provision, means a proposal, revision or modification of a proposal, or withdrawal of a proposal that is transmitted to and received by the Government via facsimile machine.

(b) Offerors may submit facsimile proposals as responses to this solicitation. Facsimile proposals are subject to the same rules as paper proposals.

(c) The telephone number of receiving facsimile equipment is: (770) 488-2044

(d) If any portion of a facsimile proposal received by the Contracting Officer is unreadable to the degree that conformance to the essential requirements of the solicitation cannot be ascertained from the document—

(1) The Contracting Officer immediately shall notify the offeror and permit the offeror to resubmit the proposal;

(2) The method and time for resubmission shall be prescribed by the Contracting Officer after consultation with the offeror; and

(3) The resubmission shall be considered as if it were received at the date and time of the original unreadable submission for the purpose of determining timeliness, provided the offeror complies with the time and format requirements for resubmission prescribed by the Contracting Officer.

(e) The Government reserves the right to make award solely on the facsimile proposal. However, if requested to do so by the Contracting Officer, the apparently successful offeror promptly shall submit the complete original signed proposal.

E.1.4.

Paragraph (l), incorporating FAR clause 52.233-2, Service of Protest, is added as follows:

(l) 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: Cherie Katin

2920 Brandywine Road, M/S K-14

(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.

Paragraph (m), incorporating the Inquiries clause is added as follows:

(m) Inquiries

Inquiries concerning the solicitation document should be submitted in writing to the issuing office. Any additions, deletions, or changes to the solicitation will be made by an amendment. OFFERORS ARE INSTRUCTED SPECIFICALLY TO CONTACT ONLY THE CONTRACTING OFFICER IN CONNECTION WITH ANY ASPECT OF THIS REQUIREMENT PRIOR TO CONTRACT AWARD. PROPOSALS AND ALL CORRESPONDENCE RELATING TO THE SOLICITATION DOCUMENT SHALL BE SUBMITTED TO THE CONTRACTING OFFICE. Inquiries should be received at the Contracting Office no later than December 9, 2008 and may be submitted via facsimile to (770) 488-2044, or email: chk5@cdc.gov.

SECTION E - SOLICITATION PROVISIONS (Continued)

E.2 Evaluation and Award

E.2.1 Award Criteria

In order to be considered for award, an offeror must meet the price conditions and definition of a "Manufacturer" as stipulated by OBRA ’93 (see Definitions on Page 2), operate in accordance with the Current Good Manufacturing Regulations and provide evidence of a current FDA license for the proposed product prior to award. Product licensure is a matter of responsibility that may be demonstrated up to the time of award. Offers for vial sizes larger than those specified for Contract Line Item Numbers will not be considered.

E.2.2 Pricing

This acquisition of vaccine is subject to Section 13631 of the Omnibus Budget Reconciliation Act of 1993 (OBRA ‘93) (42 U.S.C. 1396s). As there was no existing CDC contract for Influenza vaccine as of May 1, 1993, proposed prices are not subject ot the price ceiling restrictions contained in the OBRA ’93 language; however, as provided under Section 1928(d)(3)(C) of the Social Security Act, these prices shall be discounted prices. The Government reserves the right to withhold award for any product offered at a price deemed to be unreasonable.

E.2.3 Multiple Awards

The Government intends to award multiple contracts to responsible offerors that meet the award criteria specified in Section E.2.1 above. Contracts will be awarded for the estimated quantity stated in the solicitation or a lesser maximum quantity if specified by the offeror.

E.3

52.212-3 Offeror Representations and Certifications-Commercial Items (Jan 2005) An offeror shall complete only paragraph (j) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (b) through (i) of this provision.

(a) Definitions. As used in this provision:

"Emerging small business" means a small business concern whose size is no greater than 50 percent of the numerical size standard for the NAICS code designated.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Service-disabled veteran-owned small business concern"-

(1) Means a small business concern-

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

"Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

"Veteran-owned small business concern" means a small business concern-

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

"Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

"Women-owned small business concern" means a small business concern-

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

(b) Taxpayer Identification Number (TIN) (26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable if the offeror is required to provide this information to a central contractor registration database to be eligible for award.)

(1) All offerors must submit the information required in paragraphs (b)(3) through (b)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS).

(2) The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror's TIN.

(3) Taxpayer Identification Number (TIN).

o TIN: _____________________.

o TIN has been applied for.

o TIN is not required because:

o Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States;

o Offeror is an agency or instrumentality of a foreign government;

o Offeror is an agency or instrumentality of the Federal Government.

(4) Type of organization.

o Sole proprietorship;

o Partnership;

o Corporate entity (not tax-exempt);

o Corporate entity (tax-exempt);

o Government entity (Federal, State, or local);

o Foreign government;

o International organization per 26 CFR 1.6049-4;

o Other _________________________.

(5) Common parent.

o Offeror is not owned or controlled by a common parent;

o Name and TIN of common parent:

Name ___________________.

TIN _____________________.

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it o is, o is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it o is, o is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it o is, o is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, for general statistical purposes, that it o is, o is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The…