Solicitation2010-Q-12222 Merck Commercial Solicit 4.doc

PAGE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

2010-Q-12222

6. SOLICITATION

ISSUE DATE

Gary Morgan

b. TELEPHONE NUMBER (No collect calls)

(770) 488-2639

8. OFFER DUE DATE/

LOCAL TIME

12. DISCOUNT TERMS

FORMTEXT

Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Branch B

2920 Brandywine Road

Atlanta, GA 30341-5539

X UNRESTRICTED

SIC:

SIZE STANDARD:

X SEE SCHEDULE

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Branch B

2920 Brandywine Road

Atlanta, GA 30341-5539

CODE

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

Atlanta, GA 30333-0080

TELEPHONE NO.

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

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

“See Continuation Page”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

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

28.

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

29.

AWARD OF CONTRACT: REFERENCE

DATED

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

30c. DATE SIGNED

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

31c. DATE SIGNED

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 OF SF1449tc \l2 "CONTINUATION OF SF 1449

B.1 FUNDING AND VACCINE QUANTITIES

This contract will cover storage and rotation services for any vaccines that have been set aside by the Contractor for Government stockpile purposes. The doses set forth in the table below represent the number of doses at the time of contract award. This contract may be modified as agreed upon by the parties to decrease quantities of vaccines listed herein and/or add additional quantities of other vaccines acquired from the Contractor for stockpile purposes.

Period: July 1, 2010 – June 30, 2011

Storage, maintenance and rotation of 3,675,000 doses of

M-M-R II® (MMR) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

3,675,000 doses

Storage, maintenance and rotation of 3,750,000 doses of Varivax® (Varicella) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

3,750,000 doses

Storage, maintenance and rotation of 2,200,000 doses of Recombivax®HB (Hep B) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

2,200,000 doses

Storage, maintenance and rotation of 1,700,000 doses of PedvaxHIB® (Hib) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

1,700,000 doses

Storage, maintenance and rotation of 1,000,000 doses of Vaqta® (Hep A) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

1,000,000 doses

Storage, maintenance and rotation of 500,000 doses of Comvax® (HepB-Hib) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

500,000 doses

Storage, maintenance and rotation of 2,500,000 doses of RotaTeq® (Rotavirus) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

2,500,000 doses

Storage, maintenance and rotation of 234,460 doses of Gardasil® (HPV) vaccine in the CDC National Stockpile which will be located at the Merck storage facility(ies).

234,460 doses

Price Breakdown Table:

Period: July 1, 2009 – June 30, 2011

Computation: (a) times (b) equals (c) times (d) equals (e)

Note: CDC will pay on a quarterly basis for the costs of the actual number of doses stored and rotated in the CDC Stockpile.

B.2 Background The first national vaccine stockpiles were started in 1983 with a Congressional appropriation to CDC. In 1993, the Vaccine for Children (VFC) program was established pursuant to Section 13631 of the Omnibus Budget Reconciliation Act of 1993 (OBRA ’93). 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. OBRA ‘93 also authorized VFC funds for stockpile purchases and charged CDC with managing the stockpiles for use in outbreaks of vaccine preventable diseases as well as vaccine supply disruptions. The goal of the stockpile program is to ensure a six month national supply of routinely recommended pediatric vaccine to protect all children, whether served within the public or private healthcare settings. To support this goal, stockpiles have been structured as storage and rotation stockpiles that allow CDC immediate access to viable and releasable vaccine as required.

B.3 SCOPE

B.3.1 This contract provides for storage, rotation and maintenance of CDC’s vaccines identified herein which will be used as a national stockpile. The Centers for Disease Control and Prevention has purchased vaccines under a separate supply contract or delivery order, and the Contractor shall provide storage of the same at a Contractor-furnished site. This contract may be modified to add additional quantities or decrease quantities of vaccines identified in the statement of work, and/or modified to add quantities of other vaccines acquired from the Contractor for stockpile purposes. Material shall be held at the storage site for subsequent distribution as required under Final Distribution of Stockpile, B.12.4.

a.

The Contractor shall inventory and maintain quality control of CDC-owned vaccine at the Contractor facility. The Contractor shall store the vaccine in a secure and proper temperature controlled area; properly manage the inventory of same; and maintain CDC-owned vaccine within the minimum shelf-life expectancy agreed upon and described within this contract.

b.

Due to the unique nature of the stockpile, the parties expressly agree that the CDC will not request Contractor to, nor will it distribute or relocate any product from the Contractor's facility which has not been fully released by Contractor and/or the Center for Biologics Evaluation and Research (CBER), as the case may be. In the event that (i) product in the CDC stockpile will not be released by Contractor and/or CBER and (ii) Contractor believes it will be unable to fulfill Distribution Orders in accordance with the delivery timeframes set forth in Time of Distribution, B.12.3.C, then Contractor shall notify the CDC within 48 hours of such knowledge.

c. The Contractor shall provide names, titles, and telephone numbers (non-emergency and emergency) of its representatives, who will be contacted for visits, inventory status, and access to and/or deployment or a simulated deployment of the CDC-owned property, during normal business hours of 8:00 AM – 5:00 PM ET and after hours, within 10 working days after award of this contract. For distribution of CDC-owned vaccine, the Contractor shall be required to pick stock using a faxed, e-mailed, or electronically submitted CDC order list. The Contractor shall also be required to prepare vaccine for shipping and distribution.

d. CDC will identify authorized representatives, including titles and telephone numbers, who will be granted access to the Contractor’s facility within 10 days after the award of this contract. The CDC shall notify the Contractor, by telephone and in writing, of any updates or changes to this list within 24 hours of any updates or changes.

e. The CDC will make announced/scheduled visits to the Contractor’s facility for the purpose of inspection and review of its inventory.

f . Upon termination of this stockpile contract, a final plant clearance inspection may be made by the CDC to insure that all CDC-owned vaccine has been depleted or removed. The Contractor will provide a final inventory report to the CDC upon termination. The Contractor will retain the contract agreement and inventory reports for a maximum of seven years from the date of conclusion of this contract and these records are to be destroyed upon the seven year anniversary date of the expiration of this contract.

B.4 ACQUISITION OF VACCINE

For reference, the following information is provided regarding the original acquisition of the vaccine:

Contract Number Date

D.O. 25170 09/14/83

D.O. 35022 11/09/83

D.O. 37170 07/30/84

D.O. 95111 06/11/86

D.O. 95159 09/12/86

D.O. 46065 01/16/87

D.O. 890172 12/15/89

D.O. 945231 03/01/90

D.O. 9045289 09/19/90

D.O. 9145211 05/29/91

D.O. 0001/Mod 1 06/01/01

09/19/03

Mod # 4 04/18/06

Transfer of doses to McKesson – Mod 4 08/04/08

Contract Number Date

09/08/03

Contract Number Date

09/8/03

08/21/06

* Borrowed doses to be replaced by Merck at a later date to be mutually agreed to by the parties.

Contract Number Date

** Borrowed and recalled doses to be replaced by Merck at a later date to be mutually agreed to by the parties.

Contract Number Date

* Borrowed doses to be replaced by Merck at a later date to be mutually agreed to by the parties.

Contract Number Date

*** Recalled and expired doses to be replaced by Merck at a later date to be determined.

Contract Number Date

Contract Number Date

B. 5 STORAGE SITE

The storage site for vaccine under this contract shall be at the addresses shown below. Additional sites may be used upon receipt of written approval from the Contracting officer.

Primary

Merck & Co., Inc.

770 Sumneytown Pike

West Point, PA 19486

Alternate

Merck & Co., Inc.

1645 Satellite Blvd.

Duluth, Ga 30097

B.6 STORAGE CONDITIONS

(a) Vaccines shall be maintained in a manner to meet the Government’s availability and time of distribution requirements. One hundred percent (100%) of vaccines in the stockpile must be released by the Center for Biologics Evaluation and Research (CBER).

(b) Vaccines in the CDC stockpile shall be stored to ensure potency such that all vaccines shall have no less than twelve (12) months of shelf life remaining.

(c) CDC will pay on a quarterly basis for the costs of the actual number of doses stored and rotated in the CDC Stockpile. CDC will not pay storage and rotation fees for any stockpiled vaccine with less than 12 months expiry unless otherwise agreed to in writing.

B.7 SHELF LIFE, STOCKPILE ROTATION, AND PRODUCT VARIANCES

Rotation/removal of vaccines for purposes other than directed distribution shall be as follows:

(a) The Contractor shall be permitted to remove vaccines from the stockpile for the purposes of rotation only and replaced in an amount at least equal to the doses removed within 48 hours. Additional vaccines may be made available to the Contractor upon approval by the Contracting Officer for Contractor's use. Approval will be contingent upon an agreement as to satisfactory distribution. Replacement shall be made within 30 days after removal or as otherwise agreed by the parties. The Contractor shall not decrease the stockpile for purposes of this Sub-paragraph (a) without prior approval of the Contracting Officer.

(b) Should the stockpile exceed the actual quantities of vaccines ordered due to production variances, the excess shall be the property of Contractor at no cost to the Government. Should the quantities of vaccine in the stockpile fall below the ordered doses and the Government orders the stockpile distributed, the Contractor shall credit the Government at the actual price of initial payment for the shortage (End of Clause)

B.8 Packaging And Marking

The contractor shall provide packaging and marking in the event the CDC directs the contractor to distribute the product. For specific instructions about packaging and marking see Time of Distribution, B.12.3.C.

B.9 Inspection And Acceptance

Per below FAR clause:

B.9.1

B.9.2 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Project Officer) at the Merck storage facility.

(End of Clause)

B.10 Deliveries Or Performance

B.10.1 FAR 52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either –

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if –

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

B. 10.2 Distribution

Ordering, distribution times and terms and conditions are covered in the Release of Stockpile Vaccine, B.12.3 and Final Distribution of Stockpiled Vaccine, B.12.4.

B. 10.3 Period of Performance (Jul 1999)

The period of performance shall be a period of 12 months..

(End of Clause)

B.10.4 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at a designated facility authorized under the contract. (See B.5., Storage Site.)

B.10.5 Inventory Reports a.

The Contractor shall provide the Centers for Disease Control and Prevention with quarterly inventory summaries of all vaccines in the stockpile. CDC may direct the Contractor to provide more frequent inventory summaries of all vaccine during periods when vaccine is being delivered to or withdrawn or borrowed from CDC’s pediatric vaccine stockpile at Merck. Inventories shall be current as of the last working day of the month in which the quarter ends, and submitted within 30 days following the end of the quarter. The report shall include the Contractor’s name and address, the report date, and provide the following information for each vaccine lot:

Lot Number

Expiration Date

Number of Vials or tubes

Bulk Quantity (if applicable)

Total Doses in Storage

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

B.11 Contract Administration Data

B.11.1 Applicable Service Contract Act Wages (Jul 1999)

The attached Wage Determination, No. 2005-2450 dated 4/4/2008 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.)

(End of Clause)

B.11.2 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)

B.11.3 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.

B.11.4 Payment by Electronic Funds Transfer (Dec 2005) (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 D, Clauses, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

B.11.5 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.

B.11.6 Invoice Submission - part 1 (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 3033

Or – The Contractor may submit the original invoice/voucher via facsmile 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 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) Quantity

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

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

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

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

(13) DUNS + 4 Number b.12 Special Contract Requirements

B.12.1 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)

a) 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.

b) Section 1352 of Title 10, United Stated 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 of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

c) 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.

d) 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.

(End of Clause)

B.12.2 INTRODUCTION OF AN FDA APPROVED PRODUCT

In the event that during the term of the contract the Contractor shall receive a license from FDA for a new vaccine for any of the same diseases currently covered by vaccines in this contract, the Contractor shall promptly notify CDC of receipt of any such license. If the Government opts for storage of both vaccines, quantities and schedule will be mutually agreed upon.

B.12.3 RELEASE OF STOCKPILED VACCINE

A.

Placement of Orders Against Stockpile

(1)

Emergency Situations – Emergency situations are defined as an outbreak of disease for which the vaccine is specified or situations where a shortage of vaccine has occurred based on production or other problems which require the use of the government stockpiles. Under these situations, the Contracting Officer, acting under directions from CDC Leadership, shall issue a written notification of a declared emergency to the Contractor. Upon such declaration, distribution orders may be placed by the CDC. Distribution orders are requests from the CDC for Merck to ship product to any authorized state and/or local health agency(ies) and/or other provider(s) and/or other CDC approved locations.

(2) Non-Emergency Reductions –

(a) To ensure potency of vaccine held in stockpiles and eliminate the opportunity of wastage, the CDC and Contractor will review periodically and make necessary adjustments as agreed upon by the parties, to the target levels. CDC will make adjustments to the levels of vaccines held in stockpiles using the guidelines under this section.

(b) If CDC determines that the amount of any vaccine held in stockpile should be reduced then the stockpile may be reduced by filling CDC orders within normal usage of the supply and not replacing stockpiled vaccine removed from the inventory.

(c) CDC may place orders against the stockpile for this purpose, provided CDC notifies the Contractor in writing 30 days in advance of beginning the reduction process. In the event that CDC places orders in accordance with this paragraph, it will be done on a schedule mutually agreed upon by both parties.

(3) Changing the Location of the Stockpile – If CDC determines that an amount of any vaccine held in stockpile should be moved from the Contractor storage location to a different storage location the CDC will direct the Contractor, in writing, to send vaccines from their storage location to another CDC approved location. Once quantites of vaccine have been moved to another storage site location not owned and operated by the Contractor, the Contractor's responsibility for the storage and rotation of said vaccine will cease.

(4) Ordering - Upon declaration as stated in (1) or (2) above, distribution orders may be placed by the CDC or other agents of the Government as authorized in writing by CDC and shall contain the following minimum information:

(a) Date of Order

(b) Contract Number and Order Number

(c) Item Description, Quantity and Unit Price

(d) Distribution or Performance Date

(e) Place of Delivery or Performance (Including Consignee)

(f) Packaging, Packing and Shipping Instructions (If Any)

(g) Accounting and Appropriation Data

(h) Any Other Pertinent Data

B. Place of Distribution

1) For all vaccines other than VARIVAX,® upon receipt of written distribution order(s), the Contractor shall be required to distribute vaccine, at no additional charge to the Government, as directed by distribution orders, to National, State, and regional warehouses, as well as to private distributors under contract with the federal or state governments (provided that the private distributor indemnifies or obtains insurance to indemnify, defend, or hold harmless the Contractor from any claims and costs arising from or resulting from the distributor's handling of the vaccine delivered under this contract. However, the Contractor agrees that it will not require any indemnification by the distributor to the extent liability is caused by the acts or omissions of the Contractor) within the 50 states, the District of Columbia, Puerto Rico, Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Federated State of Micronesia, and the Marshall Islands or other designated sites in the even of a public health emergency determined by the CDC. No more than four (4) shipments each to Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Federated State of Micronesia, and the Marshall Islands will be required. In the event the CDC requests the Contractor to make such shipments in accordance with the preceding sentence, CDC and the Contractor agree to discuss how to implement distribution of vaccine to those sites in the most efficient manner.

2) For Varivax®, upon receipt of written distribution order(s), the Contractor shall be required to distribute vaccine, at no additional charge to the Government, as directed by distribution orders from the CDC, to National, State and regional warehouses, (provided that the warehouse is validated solely by the CDC, or its appointed independent agent, as being able to store, ship, and handle Varivax at -15 degree celsius) and individual physician providers, as well as to private distributors under contract with the federal or state governments (provided that the private distributor: 1) is validated solely by the CDC or its appointed independent agent as being able to store, ship, and handle Varivax at -15 degree celsius; and 2) indemnifies or obtains insurance to indemnify, defend, or hold harmless the Contractor from any claims and costs arising from or resulting from the distributors handling of the vaccine distributed under this contract. However, the Contractor agrees that it will not require any indemnification by the distributor to the extent liability is caused by the acts or omissions of the Contractor) within the 50 states, the District of Columbia, Puerto Rico, Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Federated States of Micronesia, and the Marshall Islands or other designated sites in the event of a public health emergency determined by CDC. No more than four (4) shipments each to Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Federated States of Micronesia, and the Marshall Islands or other designated sites in the event of a public health emergency determined by CDC. No more than four (4) shipments each to Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Federated States of Micronesia, and the Marshall Islands will be required. In the event that CDC requests the Contractor to make such shipments in accordance with the preceding sentence, CDC and the Contractor agree to discuss how to implement distribution of vaccine to those sites in the most efficient manner.

3) There shall be no additional charges to the Government for the final packaging and distribution to ultimate consignee. (Except as specified in sub-paragraph B above, regarding payment of surcharges and applicable federal excise taxes for certain vaccines.)

C. Time of Distribution (1) The Contractor shall distribute Measles, Mumps and Rubella vaccine, Hepatitis B vaccine, Haemophilus b Conjugate vaccine, Hepatitis A vaccine, Hepatitis B-Hib Combination Vaccine, Rotavirus, or HPV Vaccine in emergency, non-emergency and other situations, as ordered by the Government, to the consignee. The Contractor shall begin shipping vaccine within two (2) Shipping Days after receipt of order and shall continue shipping on subsequent Shipping Days until the distribution order is completed. A Shipping Day is defined as Monday through Thursday, excluding Contractor holidays. The Contractor shall ship a minimum of 150,000 doses per shipping day unless a smaller quantity is ordered.

(2) The Contractor shall distribute Varicella vaccine in emergency, non-emergency and other situations, as ordered by the Government, to the consignee. The Contractor shall begin shipping vaccine within two (2) Shipping Days after receipt of order and shall continue shipping on subsequent Shipping Days until the distribution order is completed. A Shipping Day is defined as Monday through Thursday, excluding Contractor holidays. The Contractor shall ship a minimum of 60,000 doses per Shipping Day unless a smaller quantity is ordered.

(3) The Contractor agrees to work with the Contracting Officer to accelerate vaccine deliveries when possible.

D. Packaging, Packing and Marking Requirements

All vaccines shall be packaged and marked in standard commercial manner. Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. Merck will provide appropriate shipper insert(s) in each shipment to provide direction to recipients regarding procedures to follow if vaccine is not received within the allotted timeframe indicated on the shipper insert, including instructions for replacement if appropriate. Non-frozen vaccines shipped in case-pack size or greater quantities will have temperature monitoring devices included with each shipment.

E. Return Privileges

Return privileges do not apply to this contract.

F. Duty To Warn

1) The Department of Health and Human Services (HHS), HHS Supply Service Center, Centers for Disease Control and Prevention (CDC), and other HHS, Federal and State agencies as authorized, hereinafter referred to as the Government represent and agree that all programs which are supplied vaccine under this contract shall take appropriate steps to assure either: (1) that such vaccine is administered to each patient on the basis of an individualized medical judgment by a physician; or (2) that such vaccine is administered after meaningful warnings related to the risks and benefits of vaccination are provided to such patient (or the patient’s parent or legal guardian), in form and language understandable to such patient, parent, or guardian, including through use of appropriate version of the most recent vaccine information materials.”

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

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

B.12.4 FINAL DISTRIBUTION OF STOCKPILE

a) In the event this contract is discontinued, disposition instructions shall be provided to the Contractor within 30 days after notification to terminate. No additional termination charges shall apply. other than those specified in Place of Distribution and Final Distribution of Stockpile.

b) Upon expiration or termination (including partial termination) of this contract, including a decision not to exercise options to renew, the Government may effect final distribution of any vaccine remaining in storage by any one or combination of the following methods:

1) The Government may elect to place orders against the stockpile or authorize orders by state and local health agencies and/or other providers. Terms and conditions of the orders shall be in accordance with, Release of Stockpiled Vaccine, B.12.3 herein.

2) The Government may direct the Contractor to destroy all quantities remaining in storage at no additional charge to the Government

3) Upon final distribution, the Contractor cannot reclaim title to product upon distribution.

B.12.5

TRANSFER OF TITLE OF VACCINE TO THE GOVERNMENT

a) The CDC and the Contractor agree that the Government has title and risk of loss to all vaccine delivered to the stockpile.

b) In the event that additional quantities of vaccine(s) are added to this contract in accordance with Section B., title and risk of loss to such vaccine shall be vested in the Government upon delivery of the vaccine to the stockpile.

B.12.6 FORCE MAJEURE

a) 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 provision and availability of this vaccine.

b) 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 storm; 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.

B.12.7

INSURANCE TO COVER GOVERNMENT OWNED VACCINE

The Contractor agrees to maintain custodial risk insurance or other similar insurance in an adequate amount to cover the value of the Government's vaccine while held in stockpile 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 cost to the Government.

B12.8

MISCELLANEOUS

The contractor stores the product(s) as government property in compliance with, FDA Good Manufacturing Processes (GMPs), manufacturer Product Package Insert (PPI) storage recommendations, and relevant standards monographs published in the U.S. Pharmacopoeia (USP) and the National Formulary (NF).

B.12.9 FAR CLAUSE NOTIFICATION

CDC understands that Merck will make all reasonable efforts to comply with the paragraph (c) of FAR clause 52.225-13 [Restrictions on Certain Foreign Purchases (Feb 2006)]and paragraph (f) of FAR clause 52.222-50 [Combating Trafficking in Persons (Aug 2007)] and shall include such provisions in all subcontracts provided hereunder. In addition, the CDC acknowledges that Merck has limited visibility and control relative to the activities of such subcontracts.

SECTION C - CONTRACT CLAUSES

Shelf Life

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

C. 2.

Time of Delivery

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

C.3

Pace of Delivery – F.O.B. Destination

The Contractor shall be required to deliver vaccines F.O.B. Destination, as directed by delivery orders to the Government’s centralized distribution locations currently in Sacramento, CA and Memphis, TN.

C.4

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.5

Product Licensure C.5.1 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:___0003 .

C.5.2 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.5.3 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.6.

Placement of Orders

C.6.1 All vaccine under this contract will be ordered by delivery orders. Orders shall be placed by the Health and Human Services, the Centers for Disease Control and Prevention (Government); and authorized State agencies. The Government may place orders by telephone (confirmed in writing) or by electronic transfer.

C.6.2 Some orders may be placed using American Recovery and Reinvestment Act (ARRA) of 2009 funds and the contractor shall comply with all ARRA reporting requirements.

Orders shall be submitted to the Ordering Address specified in Contract Clauses Paragraph I.1.10; 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 instruction, 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.7 Delivery Order Limitations C.7.1 Minimum Order Size: Individual delivery orders issued under this contract must meet the minimum order size as specified within each Contract Line Item Number (See Section B, Continuation of SF 1449). When the Government requires supplies covered by this contract in amounts less than stated above, the Government is not obligated to purchase, nor is the Contractor obligated to furnish those supplies under this contract.

C.7.2 Maximum Order: The maximum quantity specified within each Contract Line Item Number (See Section B, 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 Government and authorized State agencies. Contractors are advised that the maximum quantity represents their commitment to the Government under their contract.

C.7.3 Delivery Orders shipments:

i.

The Government shall not be obligated to purchase doses that exceed the delivery order requirements. Contractor shall be obligated for cost associated with the return of excess doses conveyed by Contractor. The govenernment shall notify the contractor when excess doses have been delivered to the distribution sites. Contractor shall be obligated for cost associated with return of excess doses shipped in error.

ii. Bulk order shipments, when possible, shall consist of:

a. One NDC per skid

b. Full skid with same lot number

c. Full case quantities (when total order size allows)

C.8.

FAR 52.216-18 ORDERING (OCT 1995)

C.8.1. 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.

C.8.2 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.8.3 If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail.