2010-N-11860_FLU_vfc_SOL_ AMENDMENT 0001.doc

PAGE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

00HCVGBC-2010-78330

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

2010-N-11860

6. SOLICITATION

ISSUE DATE

1/8/2010

Cherie J. Katin

b. TELEPHONE NUMBER (No collect calls)

(770) 488-2652

8. OFFER DUE DATE/

LOCAL TIME

1/25/2010

12. DISCOUNT TERMS

FORMTEXT

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO) 2920 Brandywine Rd, M/S K-14 Atlanta, GA 30341-5539

X UNRESTRICTED

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 (CDC)

Procurement and Grants Office (PGO) 2920 Brandywine Rd, M/S K-14

CODE

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

Atlanta, GA 30333-4018

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

2010 Influenza Virus Vaccines for Children - RECOVERY

AMENDMENT 0001

“See Continuation Page”

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

X ARE

28.

X

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

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

29.

AWARD OF CONTRACT: REFERENCE

DATED

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

30c. DATE SIGNED

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

Nancy M. Norton 31c. DATE SIGNED

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. Some orders may be placed using American Recovery and Reinvestment Act (ARRA) of 2009 funds, and contractor shall be responsible for compliance with all ARRA reporting requirements.

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:

9,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2011 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:

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) (Age: 6 months and older)

Maximum Estimated Quantity:

3,300,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2011 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) (Age: 36 months and older)

5,800,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2011 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) (Age: 4 years and older)

Maximum Estimated Quantity:

2,000,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2011 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 – Live Intranasal –

Preservative Free (Age 2 – 49 years)

8,300,000 Doses

Guaranteed Minimum Quantity:

100 Doses

Product Requirements:

Minimum Shelf Life:

Expiration date of June 30, 2011 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):

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, 2011 or later upon delivery to the consignee..

C.1.2.

Packaging and Packing Requirements 1.

Packaging:

All items shall be packaged in standard commercial manner.

2.

Packing:

a. Product shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. An electronic temperature monitoring device is required with each shipment unless contractor has obtained prior approval from CDC to use an alternative monitoring method.

b. Vaccine Shipment Temperature Excursions:

Contractor will provide the Project Officer with documentation that explains the cause of each temperature excursion and stability data used by the contractor to determine if the cold chain was adversely affected by temperature variance. Upon review of data provided, CDC will notify appropriate parties if the vaccine is accepted or rejected.

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, 2011.

C.1.4.

Time of Delivery Offeror shall propose delivery schedule. After award of contract, any deviation from proposed schedule must demonstrate equal treatment among all contractor customer (public and private sectors). If it is determined that the Government was not given equal or preferential treatment, the change may be considerd default of contract.

C.1 – Contract Clauses (Continued)

C.1.5.

Place of Delivery - F.O.B. Destination The Contractor shall be required to deliver vaccines F.O.B Destination, as directed by delivery order to the CDC centralized distribution locations currently in Sacramento, CA and Memphis, TN.

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.

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 maximum quantity specified within each Contract Line Item Number (See, Continuation of SF 1449) is the maximum number of doses that may be ordered during the contract period of performance. This includes orders from the HHS Supply Service Center and other users. Contractors are advised that the maximum quantity represents their commitment to the Government under their contract.

The Government intends to submit first prebook orders to Contractors nlt June 2, 2010. Upon receipt of the initial prebook orders, contractors will have the opportunity to decrease the maximum quantity of each Contract lIne Item to 130% of the initial prebook. The Government will notify Contractors of its commitment to order additional vaccines nlt October 15, 2010.

c. Delivery Order Shipments:

(1) The Government reserves the right to reject vaccine doses that exceed delivery order requirements. The government shall notify the Contractor when excess doses have been delivered to distribution sites. The contractor is responsible for contacting the distribution sites to make arrangement for the return of excess doses and will be responsible for shipping cost associated with their return..

(2) Bulk 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.1.10.

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

Name of Purchaser:

Number of Doses Purchased:

Lot Number:

C.1 – Contract Clauses (Continued)

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

Contractor shall complete all reporting requirements for ARRA funded projects. Registration in "FederalReporting. gov" is required in order to submit quarterly ARRA reports that identify the number of jobs created or maintained as a result of this contract.

C.1.13 Contractor’s Ordering/Payment Address Submission of all orders for Contractor’s vaccines and payment of invoices should be addressed as referenced below:

ORDERING ADDRESS

PAYMENT ADDRESS

C.1.14.

Invoice Submission a.

Invoice submission under this contract will be made as follows:

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

b.

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

(1) Contractor's name and invoice date;

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

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

(4) Shipping and payment terms;

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

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

(7) NDC and Lot number of vaccine vials shipped;

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

C.1 – Contract Clauses (Continued)

C.1.15 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.1.16 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.1.17 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 privileges for credit, reimbursement or exchange do not apply to this contract except vaccines not conforming to the specifications set forth herein, which are limited to credit or exchange only.

C.1.19.

Restrictions on Use of Vaccines

Vaccines obtained under this contract shall be used only only in children 18 years of age and younger as authorized under section 1928 of the Social Security Act. Sale of such vaccine to any person or entity is strictly prohibited, except where such vaccine is administered in the context of the Grantee immunization activities.

C.1 – Contract Clauses (Continued) 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 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 the CDC VFC or 317 Fund account,, a credit memo shall be submitted to:

Centers for Disease Control and Prevention

National Center for Immunization and

Respiratory Diseases

Immunization Services Division

Vaccine Supply and Assurance Branch

Mailstop E-52, Attn: Deberal Denson

1600 Clifton Road

Atlanta, GA 30333

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 requires for FET credit..

C.1.21 Use of VFC Provider Lists and Distribution of Material

a. Contractors are prohibited from utilizing VFC provicers’ lists obtained from any source for any mailing or other communication with VFC providers, excepta s approved in writing by the CDC Porject Officer. In addition, contractors are prohibited from otherwise communicating with VFC providers requarding the VFC program, except as approved in writing by the CDC Project Officer. To the extent that contracts have established relationships with VFC providers or authorized purchasers under this contract that are independent from the VFC program, communication 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 cases, the CDC Project Officer shall be notified in writing.

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 theContractor 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 requreid such as handling instruction or eductionas materials should not contain any; promotional material as part of its content.

C.1.22 Delinquent Delivery Reports

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

C.1.23 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.1.24 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 – Contract Clauses (Continued) C.1.25 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 agreed upon delivery schedule 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.1.26 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.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)

C.3 52.204-11 American Recovery and Reinvestment Act-Reporting Requirements.

As prescribed in 4.1502, insert the following clause:

American Recovery and Reinvestment Act—Reporting Requirements (Mar 2009)

(a) Definitions. As used in this clause—

“Contract”, as defined in FAR 2.101, means a mutually binding legal relationship obligating the seller to furnish the supplies or services (including construction) and the buyer to pay for them. It includes all types of commitments that obligate the Government to an expenditure of appropriated funds and that, except as otherwise authorized, are in writing. In addition to bilateral instruments, contracts include (but are not limited to) awards and notices of awards; job orders or task letters issued under basic ordering agreements; letter contracts; orders, such as purchase orders, under which the contract becomes effective by written acceptance or performance; and bilateral contract modifications. Contracts do not include grants and cooperative agreements covered by 31 U.S.C. 6301, et seq. For discussion of various types of contracts, see FAR Part 16.

“First-tier subcontract” means a subcontract awarded directly by a Federal Government prime contractor whose contract is funded by the Recovery Act.

“Jobs created” means an estimate of those new positions created and filled, or previously existing unfilled positions that are filled, as a result of funding by the American Recovery and Reinvestment Act of 2009 (Recovery Act). This definition covers only prime contractor positions established in the United States and outlying areas (see definition in FAR 2.101). The number shall be expressed as “full-time equivalent” (FTE), calculated cumulatively as all hours worked divided by the total number of hours in a full-time schedule, as defined by the contractor. For instance, two full-time employees and one part-time employee working half days would be reported as 2.5 FTE in each calendar quarter.

“Jobs retained” means an estimate of those previously existing filled positions that are retained as a result of funding by the American Recovery and Reinvestment Act of 2009 (Recovery Act). This definition covers only prime contractor positions established in the United States and outlying areas (see definition in FAR 2.101). The number shall be expressed as “full-time equivalent” (FTE), calculated cumulatively as all hours worked divided by the total number of hours in a full-time schedule, as defined by the contractor. For instance, two full-time employees and one part-time employee working half days would be reported as 2.5 FTE in each calendar quarter.

“Total compensation” means the cash and noncash dollar value earned by the executive during the contractor’s past fiscal year of the following (for more information see 17 CFR 229.402(c)(2)):

(1) Salary and bonus.

(2) Awards of stock, stock options, and stock appreciation rights. Use the dollar amount recognized for financial statement reporting purposes with respect to the fiscal year in accordance with the Statement of Financial Accounting Standards No. 123 (Revised 2004) (FAS 123R), Shared Based Payments.

(3) Earnings for services under non-equity incentive plans. Does not include group life, health, hospitalization or medical reimbursement plans that do not discriminate in favor of executives, and are available generally to all salaried employees.

(4) Change in pension value. This is the change in present value of defined benefit and actuarial pension plans.

(5) Above-market earnings on deferred compensation which is not tax-qualified.

(6) Other compensation. For example, severance, termination payments, value of life insurance paid on behalf of the employee, perquisites or property if the value for the executive exceeds $10,000.

(b) This contract requires the contractor to provide products and/or services that are funded under the American Recovery and Reinvestment Act of 2009 (Recovery Act). Section 1512(c) of the Recovery Act requires each contractor to report on its use of Recovery Act funds under this contract. These reports will be made available to the public.

(c) Reports from contractors for all work funded, in whole or in part, by the Recovery Act, and for which an invoice is submitted prior to June 30, 2009, are due no later than July 10, 2009. Thereafter, reports shall be submitted no later than the 10th day after the end of each calendar quarter.

(d) The Contractor shall report the following information, using the online reporting tool available at www.FederalReporting.gov.

(1) The Government contract and order number, as applicable.

(2) The amount of Recovery Act funds invoiced by the contractor for the reporting period. A cumulative amount from all the reports submitted for this action will be maintained by the government’s on-line reporting tool.

(3) A list of all significant services performed or supplies delivered, including construction, for which the contractor invoiced in this calendar quarter.

(4) Program or project title, if any.

(5) A description of the overall purpose and expected outcomes or results of the contract, including significant deliverables and, if appropriate, associated units of measure.

(6) An assessment of the contractor’s progress towards the completion of the overall purpose and expected outcomes or results of the contract (i.e., not started, less than 50 percent completed, completed 50 percent or more, or fully completed). This covers the contract (or portion thereof) funded by the Recovery Act.

(7) A narrative description of the employment impact of work funded by the Recovery Act. This narrative should be cumulative for each calendar quarter and only address the impact on the contractor’s workforce. At a minimum, the contractor shall provide—

(i) A brief description of the types of jobs created and jobs retained in the United States and outlying areas (see definition in FAR 2.101). This description may rely on job titles, broader labor categories, or the contractor’s existing practice for describing jobs as long as the terms used are widely understood and describe the general nature of the work; and

(ii) An estimate of the number of jobs created and jobs retained by the prime contractor, in the United States and outlying areas. A job cannot be reported as both created and retained.

(8) Names and total compensation of each of the five most highly compensated officers of the Contractor for the calendar year in which the contract is awarded if—

(i) In the Contractor’s preceding fiscal year, the Contractor received—

(A) 80 percent or more of its annual gross revenues from Federal contracts (and subcontracts), loans, grants (and subgrants) and cooperative agreements; and

(B) $25,000,000 or more in annual gross revenues from Federal contracts (and subcontracts), loans, grants (and subgrants) and cooperative agreements; and

(ii) The public does not have access to information about the compensation of the senior executives through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986.

(9) For subcontracts valued at less than $25,000 or any subcontracts awarded to an individual, or subcontracts awarded to a subcontractor that in the previous tax year had gross income under $300,000, the Contractor shall only report the aggregate number of such first tier subcontracts awarded in the quarter and their aggregate total dollar amount.

(10) For any first-tier subcontract funded in whole or in part under the Recovery Act, that is over $25,000 and not subject to reporting under paragraph 9, the contractor shall require the subcontractor to provide the information described in (i), (ix), (x), and (xi) below to the contractor for the purposes of the quarterly report. The contractor shall advise the subcontractor that the information will be made available to the public as required by section 1512 of the Recovery Act. The contractor shall provide detailed information on these first-tier subcontracts as follows:

(i) Unique identifier (DUNS Number) for the subcontractor receiving the award and for the subcontractor’s parent company, if the subcontractor has a parent company.

(ii) Name of the subcontractor.

(iii) Amount of the subcontract award.

(iv) Date of the subcontract award.

(v) The applicable North American Industry Classification System (NAICS) code.

(vi) Funding agency.

(vii) A description of the products or services (including construction) being provided under the subcontract, including the overall purpose and expected outcomes or results of the subcontract.

(viii) Subcontract number (the contract number assigned by the prime contractor).

(ix) Subcontractor’s physical address including street address, city, state, and country. Also include the nine-digit zip code and congressional district if applicable.

(x) Subcontract primary performance location including street address, city, state, and country. Also include the nine-digit zip code and congressional district if applicable.

(xi) Names and total compensation of each of the subcontractor’s five most highly compensated officers, for the calendar year in which the subcontract is awarded if—

(A) In the subcontractor’s preceding fiscal year, the subcontractor received—

(1) 80 percent or more of its annual gross revenues in Federal contracts (and subcontracts), loans, grants (and subgrants), and cooperative agreements; and

(2) $25,000,000 or more in annual gross revenues from Federal contracts (and subcontracts), loans, grants (and subgrants), and cooperative agreements; and

(B) The public does not have access to information about the compensation of the senior executives through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986.

(End of clause)

C.3.1 52.203-15 –Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009.

As prescribed in 3.907-7, use the following clause:

Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Mar 2009)

(a) The Contractor shall post notice of employees rights and remedies for whistleblower protections provided under section 1553 of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111–5).

(b) The Contractor shall include the substance of this clause including this paragraph (b) in all subcontracts.

(End of clause)

C.3.2 52.215-2 Audit and Records—Negotiation.

As prescribed in 15.209(b), insert the following clause:

Audit and Records—Negotiation (Mar 2009)

(a) As used in this clause, “records” includes books, documents, accounting procedures and practices, and other data, regardless of type and regardless of whether such items are in written form, in the form of computer data, or in any other form.

(b) Examination of costs. If this is a cost-reimbursement, incentive, time-and-materials, labor-hour, or price redeterminable contract, or any combination of these, the Contractor shall maintain and the Contracting Officer, or an authorized representative of the Contracting Officer, shall have the right to examine and audit all records and other evidence sufficient to reflect properly all costs claimed to have been incurred or anticipated to be incurred directly or indirectly in performance of this contract.