Solicitation 2009-N-11520 revised

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2009-N-11520

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

00HCVGBC-2010-72071

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and handcarried, in the depository located in 2:00pformtext until local time 11/17/2009 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Cherie J. Katin

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2652

C. E-MAIL ADDRESS

chk5@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs Base Cost for 8 Months of Storage and Distribution Services:

Storage and distribution of the following vaccines at a unit price of $_______ per month. The period of performance for this contract shall be no more than eight (8) months from the date of award:

A. Influenza Virus Vaccine -

Storage and distribution of up to a maximum of 200,000 doses of Pediatric Influenza Virus Vaccine in ten-pack single-dose syringes for a CDC (Centers for Disease Control and Prevention) Influenza Strategic Reserve.

B. Influenza Virus Vaccine -

Storage and distribution of up to a maximum of 188,000 doses of Influenza Virus Vaccine in ten-pack multi-dose vials for a CDC Influenza Strategic Reserve.

C. Influenza Virus Vaccine - Storage and distribution of up to a maximum of 100,000 doses of Live Intranasal Influenza Virus Vaccine in ten-pack single-dose sprayers for a CDC Influenza Strategic Reserve.

8 Months

Option 1: Vaccine Destruction and Return Services

Contract Line ITEM #

(CLIN)

The Government may destroy and/or return all or some portion of the vaccines listed in CLIN 0001. For purposes of this proposal, the Contractor will propose a cost not to exceed an amount to destroy and return/ship all vaccines to the manufacturers. (See Section C.7 (b) and Section C.7 (c) for requirements.) Once the actual quantities of vaccine to destroy and return are determined by the Government and communicated to the Contractor, the Contractor will adjust the cost accordingly.

Section C - Description/Specification/Work Statement

C.1 SCOPE OF WORK

This contract provides for the storage and distribution of influenza vaccines identified herein which will be used as a national reserve (CDC Influenza Strategic Reserve). The Centers for Disease Control & Prevention (CDC) has purchased influenza vaccines for the CDC Influenza Strategic Reserve under a separate contract and the Contractor shall provide storage of the same at Contractor-furnished site(s). The Contractor shall distribute the influenza vaccine stored as directed by CDC. Additional quantities of influenza vaccines may be added to the Influenza Strategic Reserve by modification to this contract. That additional material will also be held at the Contractor furnished storage site(s) for subsequent delivery. All vaccines stored hereunder shall remain with the Contractor until such time as the CDC directs the Contractor to deliver, or dispose of, or return to the manufacturer for Federal Excise Tax (FET) credit as directed in clause C.7, Final Distribution of Flu Vaccines in the Influenza Strategic Reserve.

C.2 STORAGE SITE

The storage site shall be located at one or more domestic facility (ies) that is/are controlled by the Contractor. The Contractor shall only store filled labeled influenza vaccines in the CDC Influenza Strategic Reserve. The Contractor shall advise CDC of the storage locations selected for storage of filled, labeled influenza vaccines stored under this contract.

Primary Storage Site: _________________________________ Secondary Storage Site: _______________________________

C.3 METHOD OF STORAGE

Vaccine shall be maintained in filled, labeled containers, as follows:

Influenza Vaccine

Amount

Filled, Labeled (Ready-to-use) 100% of all Influenza Vaccine in Influenza Strategic Reserve

C.4 STORAGE CONDITIONS

Storage shall be provided by the Contractor under conditions which will ensure maximum vaccine potency. All products shall be stored in accordance with storage conditions required by the manufacturer’s label statements (package inserts). Appropriate temperature and humidity recording equipment and/or logs document what appropriate storage requirements are being met. Principles of good manufacturing practices (GMP) should be applied.

C.5 MANAGING THE INFLUENZA STRATEGIC RESERVE

1.

Filling the Influenza Strategic Reserve with Influenza Vaccine

(a) The vaccine manufacturers will ensure that all of the influenza vaccine doses purchased by CDC for the Influenza Strategic Reserve are delivered into the Influenza Strategic Reserve maintained by the Contractor on the following schedule:

Influenza vaccine, 0.25mL, single dose syringes

200,000 doses between 12/15/2009 – 01/18/2010

Influenza vaccine, 5mL, vials

188,000 doses between 12/15/2009 – 01/18/2010

Influenza vaccine, single dose sprayers

100,000 doses between 12/15/2009 – 01/18/2010

The Contractor shall notify CDC immediately upon receipt of the influenza vaccines identified herein and:

1) Report the vaccine receipt date and report whether the vaccine was properly maintained within the recommended cold chain temperatures during transit and receipt.

2) Report whether shipping boxes were received in good condition (void of tampering, damage or contamination) and in sealed, unopened and unused states.

3) Send copies of the packing slips included with the delivered vaccines to the CDC Project Officer for this contract.

(b) Product Specifications: To assist the Contractor in calculating space requirements for the storage of these influenza vaccines, the specifications for each item are as follows:

Product: Influenza vaccine, single dose sprayers;

100,000 Doses Specifications:

2.

Storage of Influenza Vaccine in the Influenza Strategic Reserve

The Contractor will ensure that the Influenza Strategic Reserve vaccine is stored properly, and also comply with all federal and state laws, rules and regulations applicable to the storage and distribution of pharmaceutical products. This includes the maintenance of appropriate cold chain to ensure maximum vaccine potency. Refrigerated storage units shall be designed to maintain temperatures between 2° and 8° Celsius and are validated to maintain temperature complete with temperature mapping and Installation Qualification/Operational Qualification (IQOQ). These units shall be monitored by a chart recorder or local computer monitoring system. In addition, units shall have a local audible alarm and a 24-hour remote alarm monitoring system (usually a security company). With appropriate set limits, the alarm must clearly alert staff to the fact that the temperature is, or has been, outside the 2° and 8° Celsius range during and after operating hours.

3.

Directed Distribution of Influenza Vaccines by CDC

CDC will determine if and when there will be one or more distribution(s) of the influenza vaccines from the Influenza Strategic Reserve. The number, size, frequency and location of distributions varies with influenza seasons. If CDC directs the Contractor to make a distribution, CDC will provide a distribution listing to the Contractor, which will include a listing of addresses for delivery locations; and the number of influenza vaccine doses that should be distributed. The Contractor must distribute influenza vaccine to the locations indicated on the lists at no additional charge to CDC. If CDC directs the Contractor to package influenza vaccines for pick up from the Contractor’s storage site, CDC will provide contact information regarding the entity(ies) to which the vaccines will be released. The Contractor must package the influenza vaccines in accordance with packing instructions in section C.6.b., at no additional charge to CDC.

The disposition of any influenza vaccine remaining in Influenza Strategic Reserve at the end of the contract period will be made by CDC, in writing, to the Contractor and in compliance with the section entitled Distribution and Release of Vaccines in the Influenza Strategic Reserve.

C.6 DISTRIBUTION AND RELEASE OF VACCINES IN THE INFLUENZA STRATEGIC RESERVE

a.

Placement of Orders Against the Strategic Reserve

Influenza vaccine may be ordered for distribution or release from the Influenza Strategic Reserve under the following situations, as determined by CDC. Such distribution or release will be at no additional cost to the Government.

(1) Emergency Distribution - This includes situations where a shortage of influenza vaccine has occurred which require the use of the government Influenza Strategic Reserve. Under these situations, CDC will provide a list of locations to the Contractor which they will use to distribute the influenza vaccine from the Influenza Strategic Reserve.

(2) Release of Vaccines to the Manufacturer - The CDC will determine if and when it has excess influenza vaccine in the Influenza Strategic Reserve to authorize the release of such vaccines to the manufacturer. If the CDC determines that it has excess influenza vaccine that would warrant the release of such vaccine to the manufacturer to relieve shortages in the private market, the government shall so notify the Contractor and the Contractor shall agree to release defined quantities of vaccine to the manufacturer as directed by Government.

(3) Final Distribution of Influenza Strategic Reserve – Upon expiration or termination of this contract, or expiration of the shelf life of the product, CDC will effect final distribution instructions to the Contractor for any remaining influenza vaccine in accordance with section C.7, Final Distribution of Vaccines in the Strategic Reserve. The final distribution instructions will be in the form of: (1) a final inspection of the remaining influenza vaccines in the Influenza Strategic Reserves, (2) written instructions from CDC to the Contractor to commence destruction and disposal of the remaining influenza vaccines in the Influenza Strategic Reserve or return the vaccines to the manufacturer and (3) the Contractor must provide to CDC (and the vaccine manufacturer if the Contractor and vaccine manufacturer are different) a document that certifies that the remaining influenza vaccines in the Influenza Strategic Reserve were properly destroyed and disposed. CDC may begin final distribution and or disposal actions prior to the end of this contract period.

b. Packaging, Packing and Marking Requirements

All vaccines shall be labeled, packaged and marked in standard commercial manner to ensure maintenance of manufacturer recommended temperature range during transit and safe arrival at destination. The cold chain is to be maintained between 2 and 8 degrees Celsius for products throughout transit to the receiving site. Freeze Watch Indicators (FWI) or equivalent temperature indicating devices shall be properly packed, placed and secured in each container of influenza vaccine or other vaccines subsequently added to this storage and rotation contract.

The Contractor is required to maintain records in regards to distributed products that:

1) report the delivery receipt date and report whether the vaccine was properly maintained within the recommended cold chain temperatures during transit and receipt

2) indicate whether shipping boxes were received in good condition (void of tampering, damage or contamination) and in their original sealed, unopened and unused states.

Packing slips are to be included and are to specify the location of all other applicable shipment documents.

Vaccines that have been authorized by CDC to be released from the Influenza Strategic Reserve to another party should be packaged in accordance with this section at no additional charge to the Government.

c. Place of Delivery – F.O.B. Destination

(1) Upon receipt of written delivery order(s), the Contractor shall be required to deliver influenza vaccine F.O.B. Destination, as directed by CDC, within 24 hours after the receipt of order, to the designated CDC centralized distribution locations. At this time, all deliveries will be made to distribution centers in either Sacramento, California or Memphis, Tennessee.

(2) There shall be no additional charges to the Government for final packaging and delivery to ultimate consignee.

d. Retention of Vaccines in the Strategic Reserve:

Unless directed by the CDC to do otherwise, the Contractor shall retain the entire total amount of the influenza vaccine purchased in the Strategic Reserve until the end of the contract period. Influenza vaccine will be held in reserve for late season needs or disposed of in accordance with section C.7, Final Distribution of Flu Vaccines in the Strategic Reserve.

C.7

FINAL DISTRIBUTION OF VACCINES IN THE STRATEGIC RESERVE

Upon expiration or termination of this contract the Government may effect final distribution of any vaccine remaining in storage by any one or combination of the following methods:

a. The Government may elect to place orders against the Strategic Reserve or authorize orders by state and local health agencies and/or other providers. Such distribution will be at no additional cost to the Government.

b. The Government may direct the Contractor to destroy all quantities remaining in storage at a charge not to exceed that established in Section B of the contract. Such charges shall not exceed the actual costs incurred by the Contractor, and agreed to by the Government in advance of the destruction and/or disposal. The Contractor shall ensure that any disposal or destruction of the influenza vaccines will be done properly and the process shall be fully documented. CDC may direct the Contractor to provide such product destruction documentation to CDC and the vaccine manufacturer for Federal Excise Tax purposes.

c. The Government may direct the Contractor to return influenza vaccine directly to the manufacturer or manufacturer’s designee for destruction at a charge not to exceed that established in Section B of the contract. Return of vaccines to the manufacturer or the manufacturer’s designee for destruction shall be conducted in accordance with the manufacturer’s guidance for returns. CDC may direct the Contractor to provide such product return documentation to CDC and the vaccine manufacturer for Federal Excise Tax purposes. Charges for the return of vaccines to the manufacturer for destruction shall not exceed the actual costs incurred by the Contractor, and agreed to by the Government in advance of the vaccine return.

Section D - Packaging And Marking The contractor shall provide packaging and marking in the event the CDC directs the contractor to deploy the product. For specific instructions about packaging and marking see Section H, paragraph C.6 (b).

Section E - Inspection And Acceptance

E.1 Inspection

Announced or unannounced inspections of Strategic Reserve quantities and storage conditions may be made at storage facilities by a duly authorized Government representative, subject to the site security procedures of the Contractor. The Contractor shall make all directed changes as soon as possible but not later than 15 days after CDC’s identification of problems regarding storage, inventory management, or other discrepancies identified through scheduled or non-scheduled inspections.

(End of Clause)

Section F - Deliveries Or Performance

F.1 Period of Performance (Jul 1999)

The period of performance will not exceed eight (8) months from date of award.

(End of Clause)

F.2 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at a designated facility authorized under the contract. (See Section C, paragraph C.2., Storage Site.

(End of Clause)

F.3 Reports

a. Monthy Inventory Report: The Contractor shall provide the Centers for Disease Control and Prevention with monthly inventory summaries of all influenza vaccines in the CDC Strategic Reserve. CDC may direct the Contractor to provide more frequent inventory summaries of all influenza vaccine in the CDC Strategic Reserve during periods where the influenza vaccine is being withdrawn from the Strategic Reserve. Inventories reported shall be current as of the last working day of the month, and submitted within 15 days following the end of the month, unless otherwise directed by CDC. The report shall include the following information for each vaccine lot:

i. Contractor’s Name and Address

ii. Report Date

iii. Contract Line Item Numbers (CLINs)

iv. Vaccine Names and NDC (National Drug Code) Numbers

v. Vaccine Manufacturer Names

vi. Lot Numbers

vii. Expiration Dates

viii. Number of Doses

b. Monthly Vaccine Distribution and Release Reports: The Contractor shall provide the Centers for Disease Control and Prevention with monthly summaries of influenza vaccines distributed and/or released from the CDC Strategic Reserve, in accordance with Section C.6. CDC may direct the Contractor to provide more frequent distribution/release summaries during periods when there are multiple distributions during a month. Distribution and Release report summaries shall be current as of the last working day of the month and reflect each and every distribution and/or release during the month. The report is to be submitted within 15 days following the end of the month, unless otherwise directed by CDC. The report shall include the following information for each vaccine lot:

i. Contractor’s Name and Address

ii. Report Date

iii. Contract Line Item Numbers (CLINs)

iv. Vaccine Names and NDC (National Drug Code) Numbers

v. Vaccine Manufacturer Names

vi. Lot Numbers

vii. Expiration Dates

viii. Number of Doses Distributed or Released from the Reserve

ix. Date of Distribution or Release

x. Name and Address of Receipient of distributed or released vaccines

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

F.4 Deliveries

Ordering, delivery times and terms and conditions are covered in Section H, Clauses C.6, Distribution and Release of Vaccines in the Strategic Reserve and C.7, Final Distribution of Vaccines in the Strategic Reserve.

Section G - Contract Administration Data G.1 Applicable Service Contract Act Wages (Jul 1999)

The Wage Determination No. TBD Rev.TBD dated TBD , appropriate wage determination will be provided as an attachment to the contract, specifies hourly rates of wages that shall be paid to all employees performing work required under this contract. These rates have been determined by the Secretary of Labor in accordance with the provisions of the Service Contract Act of 1965, as amended. (See FAR 52.222-41, incorporated by reference in Section I.)

(End of Clause)

G.2 Project Officer (Jul 1999)

Performance of the work hereunder shall be subject to the technical directions of the Project Officer for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government Project Officer is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the delegation memorandum for the Project Officer. Any changes in Project Officer delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.3 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.4 Payment by Electronic Funds Transfer (Dec 2005)

(a) 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.

G.5 Electronic Subcontracting Reporting System (eSRS) (Dec 2005)

The contractor shall register with the Electronic Subcontracts Reporting System (eSRS) for the submission of its Individual Subcontract Report (SF 294) and the Annual Summary Reports (SF 295). Before registering in eSRS, the contractor information must be correct in Central Contractor Registration database. The eSRS is a world wide web-based application available at: http://www.esrs.gov. The eSRS website provides training and instruction for data submission.

G.6 Invoice Submission (Mar 2006)

(a) The Contractor shall submit the original contract invoice/voucher to the shown below:

The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30329

Or – The Contractor may submit the original invoice/voucher via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is FORMCHECKBOX , is not FORMCHECKBOX required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Vaccine Names and National Drug Code (NDC) numbers

(8) Quantity in Vaccine Doses

(9) Unit Price & Extended Amount for each line item

(10) Shipping and Payment Terms

(11) Total Amount of Invoice

(12) Name, title and telephone number of person to be notified in the event of a defective invoice

(13) Payment Address, if different from the information in (c)(1).

(14) DUNS + 4 Number

(End of Clause)

G.7 Evaluation of Contractor Performance (Service) (Jan 2000)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

(End of Clause)

Section H - Special Contract Requirements H.1 PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES (JULY 1999)

The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United States Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information on prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

H.2

PRODUCT INSURANCE

This contract seeks the immediate availability of influenza vaccines to the Government in the event of an unexpected need. The Government has paid for the provision and availability of this vaccine. The Contractor agrees to maintain custodial risk insurance or other similar insurance in an adequate amount to cover the replacement value of the Government’s influenza vaccine, approximately $5,444,000, while being held in the Influenza Strategic Reserve by the Contractor under this contract. The Contractor agrees to provide evidence of adequate insurance coverage upon request of the Contracting Officer. Added insurance coverage herein shall be at no additional cost to the Government. Should the influenza vaccine be damaged or destroyed by any means the Government shall be entitled to receive compensation equal to the purchase price of the product for the amount of vaccine damaged or destroyed.

H.3

TRANSFER OF TITLE OF VACCINE TO THE GOVERNMENT

The CDC and the Contractor agree that the Government has title to all vaccine delivered to the Strategic Reserve. In the event that additional quantities of vaccine(s) are added to this contract in accordance with Section B, title to such vaccine shall be vested in the Government upon delivery of the vaccine to the Strategic Reserve. Any additional cost associated with the title of the vaccine in storage being maintained by the CDC shall be assumed by the Contractor, notwithstanding any other provision of this contract, any law or FAR provision applicable to this contract, or any determination by any government entity that an additional cost should apply to the government or Contractor as a result of maintenance of title of the vaccine by CDC.

H.4 FORCE MAJEURE

This contract seeks the immediate availability of vaccines to the Government in the event of a national emergency. The Government has made an initial per unit payment for the provisional and availability of this vaccine. During the period in which the Contractor retains title and the vaccine remains in the Strategic Reserve, there is a risk of loss for both parties from causes beyond the control of either party.

The Contractor will not be responsible for damages to stored material if due to force majeure and without the fault or negligence of the Contractor. For purposes of this agreement, force majeure is defined as causes beyond the control of the contractor, including without limitation: Acts of God, earthquakes, floods, or store; act, regulations or laws of any Government; war, civil commotion, labor disturbances or failure by public utilities. Should the vaccine be damaged or destroyed by any of the above occurrences and the Contractor receives monies as part of an insurance coverage, the Government shall be entitled to receive a pro-rata share of any recovered monies.

Section I - Contract Clauses Section I-1 - Clauses Incorporated By Reference I.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acqnet.gov http://farsite.hill.af.mil/ (End of Clause)

Section I-2 - Clauses Incorporated In Full Text

I.1 FAR 52.219-6 Notice of Total Small Business Set-Aside (Jun 2003)

(a) Definition. “Small business concern,” as used in this clause, 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 size standards in this solicitation.

(b) General.

(1) Offers are solicited only from small business concerns. Offers received from concerns that are not small business concerns shall be considered nonresponsive and will be rejected.

(2) Any award resulting from this solicitation will be made to a small business concern.

I.2 FAR 52.222-42 Statement of Equivalent Rates for Federal Hires (May 1989)

In compliance with the Service Contract Act of 1965, as amended, and the regulations of the Secretary of Labor (29 CFR Part 4), this clause identifies the classes of service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332.

This Statement is for Information Only. It is not a Wage Determination

I.3 FAR 52.222-47 Service Contract Act (SCA) Minimum Wages and Fringe Benefits (May 1989)

An SCA wage determination applicable to this work has been requested from the U.S. Department of Labor. If an SCA wage determination is not incorporated herein, the bidders/offerors shall consider the economic terms of the collective bargaining agreement (CBA) between the incumbent Contractor TBD and the TBD (union). If the economic terms of the collective bargaining agreement or the collective bargaining agreement itself is not attached to the solicitation, copies can be obtained from the Contracting Officer. Pursuant to Department of Labor Regulation, 29 CFR 4.1b and paragraph (g) of the clause at 52.222-41, Service Contract Act of 1965, as amended, the economic terms of that agreement will apply to the contract resulting from this solicitation, notwithstanding the absence of a wage determination reflecting such terms, unless it is determined that the agreement was not the result of arm’s length negotiations or that after a hearing pursuant to section 4(c) of the Act, the economic terms of the agreement are substantially at variance with the wages prevailing in the area.

(End of Clause)

TBD – To Be Determined

I.5 FAR 52.245-2 Government Property (Fixed-Price Contracts) (May 2004)

(a) Government-furnished property.

(1) The Government shall deliver to the Contractor, for use in connection with and under the terms of this contract, the Government-furnished property described in the Schedule or specifications together with any related data and information that the Contractor may request and is reasonably required for the intended use of the property (hereinafter referred to as “Government-furnished property”).

(2) The delivery or performance dates for this contract are based upon the expectation that Government-furnished property suitable for use (except for property furnished “as is”) will be delivered to the Contractor at the times stated in the Schedule or, if not so stated, in sufficient time to enable the Contractor to meet the contract’s delivery or performance dates.

(3) If Government-furnished property is received by the Contractor in a condition not suitable for the intended use, the Contractor shall, upon receipt of it, notify the Contracting Officer, detailing the facts, and, as directed by the Contracting Officer and at Government expense, either repair, modify, return, or otherwise dispose of the property. After completing the directed action and upon written request of the Contractor, the Contracting Officer shall make an equitable adjustment as provided in paragraph (h) of this clause.

(4) If Government-furnished property is not delivered to the Contractor by the required time, the Contracting Officer shall, upon the Contractor’s timely written request, make a determination of the delay, if any, caused the Contractor and shall make an equitable adjustment in accordance with paragraph (h) of this clause.

(b) Changes in Government-furnished property.

(1) The Contracting Officer may, by written notice, (i) decrease the Government-furnished property provided or to be provided under this contract, or (ii) substitute other Government-furnished property for the property to be provided by the Government, or to be acquired by the Contractor for the Government, under this contract. The Contractor shall promptly take such action as the Contracting Officer may direct regarding the removal, shipment, or disposal of the property covered by such notice.

(2) Upon the Contractor’s written request, the Contracting Officer shall make an equitable adjustment to the contract in accordance with paragraph (h) of this clause, if the Government has agreed in the Schedule to make the property available for performing this contract and there is any—

(i) Decrease or substitution in this property pursuant to paragraph (b)(1) of this clause; or

(ii) Withdrawal of authority to use this property, if provided under any other contract or lease.

(c) Title in Government property.

(1) The Government shall retain title to all Government-furnished property.

(2) All Government-furnished property and all property acquired by the Contractor, title to which vests in the Government under this paragraph (collectively referred to as “Government property”), are subject to the provisions of this clause. However, special tooling accountable to this contract is subject to the provisions of the Special Tooling clause and is not subject to the provisions of this clause. Title to Government property shall not be affected by its incorporation into or attachment to any property not owned by the Government, nor shall Government property become a fixture or lose its identity as personal property by being attached to any real property.

(3) Title to each item of facilities and special test equipment acquired by the Contractor for the Government under this contract shall pass to and vest in the Government when its use in performing this contract commences or when the Government has paid for it, whichever is earlier, whether or not title previously vested in the Government.

(4) If this contract contains a provision directing the Contractor to purchase material for which the Government will reimburse the Contractor as a direct item of cost under this contract—

(i) Title to material purchased from a vendor shall pass to and vest in the Government upon the vendor’s delivery of such material; and

(ii) Title to all other material shall pass to and vest in the Government upon—

(A) Issuance of the material for use in contract performance;

(B) Commencement of processing of the material or its use in contract performance; or

(C) Reimbursement of the cost of the material by the Government, whichever occurs first.

(d) Use of Government property. The Government property shall be used only for performing this contract, unless otherwise provided in this contract or approved by the Contracting Officer.

(e) Property administration.

(1) The Contractor shall be responsible and accountable for all Government property provided under this contract and shall comply with Federal Acquisition Regulation (FAR) Subpart 45.5, as in effect on the date of this contract.

(2) The Contractor shall establish and maintain a program for the use, maintenance, repair, protection, and preservation of Government property in accordance with sound industrial practice and the applicable provisions of Subpart 45.5 of the FAR.

(3) If damage occurs to Government property, the risk of which has been assumed by the Government under this contract, the Government shall replace the items or the Contractor shall make such repairs as the Government directs. However, if the Contractor cannot affect such repairs within the time required, the Contractor shall dispose of the property as directed by the Contracting Officer. When any property for which the Government is responsible is replaced or repaired, the Contracting Officer shall make an equitable adjustment in accordance with paragraph (h) of this clause.

(4) The Contractor represents that the contract price does not include any amount for repairs or replacement for which the Government is responsible. Repair or replacement of property for which the Contractor is responsible shall be accomplished by the Contractor at its own expense.

(f) Access. The Government and all its designees shall have access at all reasonable times to the premises in which any Government property is located for the purpose of inspecting the Government property.

(g) Risk of loss. Unless otherwise provided in this contract, the Contractor assumes the risk of, and shall be responsible for, any loss or destruction of, or damage to, Government property upon its delivery to the Contractor or upon passage of title to the Government under paragraph (c) of this clause. However, the Contractor is not responsible for reasonable wear and tear to Government property or for Government property properly consumed in performing this contract.

(h) Equitable adjustment. When this clause specifies an equitable adjustment, it shall be made to any affected contract provision in accordance with the procedures of the Changes clause. When appropriate, the Contracting Officer may initiate an equitable adjustment in favor of the Government. The right to an equitable adjustment shall be the Contractor’s exclusive remedy. The Government shall not be liable to suit for breach of contract for—

(1) Any delay in delivery of Government-furnished property;

(2) Delivery of Government-furnished property in a condition not suitable for its intended use;

(3) A decrease in or substitution of Government-furnished property; or

(4) Failure to repair or replace Government property for which the Government is responsible.

(i) Government property disposal. Except as provided in paragraphs (i)(1)(i), (i)(2), and (i)(8)(i) of this clause, the Contractor shall not dispose of Government property until authorized to do so by the Plant Clearance Officer.

(1) Scrap (to which the Government has obtained title under paragraph (c) of this clause).—

(i) Contractor with an approved scrap procedure.—

(A) The Contractor may dispose of scrap resulting from production or testing under this contract without Government approval. However, if the scrap requires demilitarization or is sensitive property, the Contractor shall submit the scrap on an inventory disposal schedule.

(B) For scrap from other than production or testing the Contractor may prepare scrap lists in lieu of inventory disposal schedules (provided such lists are consistent with the…