RFQ-BARDA-08-17Solicitationw-AttachCROToxMnM-final-03-31.doc

Request for Quotations No. RFQ-BARDA-08-17

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

N/A

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

RFQ-BARDA-08-17

6. SOLICITATION ISSUE DATE

APRIL 1, 2008

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

SCHUYLER T. ELDRDIGE

CONTRACTING OFFICER

b. TELEPHONE NO. (No collect calls)

202/260-1554 schuyler.edlridge@hhs.gov

8. OFFER DUE DATE/LOCAL TIME

APRIL 16, 2008

04:30 PM EDT

9. ISSUED BY

CODE

FORMCHECKBOX

UNRESTRICTED OR FORMCHECKBOX

SET ASIDE: FOR

FORMCHECKBOX

SMALL BUSINESS FORMCHECKBOX

EMERGING SMALL

BUSINESS

FORMCHECKBOX

HUBZONE SMALL

NAICS: 325414 BUSINESS

SIZE STANDARD: FORMCHECKBOX

SERVICE-DISABLED VETERAN- FORMCHECKBOX

8(A)

500 Employees OWNED SMALL BUSINESS

U.S. DEPT OF HEALTH & HUMAN SERVICES

OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS & RESPONSE

OFFICE OF THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY

330 INDEPENDENCE AVE SW, ROOM G640

WASHINGTON, D.C. 20201

11. DELIVERY FOR FOB DESTINATION UNLESS BLOCK IS MARKED

FORMCHECKBOX

SEE SCHEDULE

12. DISCOUNT TERMS

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13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING N/A

14. METHOD OF SOLICITATION

RFQ

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IFB FORMCHECKBOX

RFP

17a. CONTRACTOR/

OFFEROR

FACILITY

18a. PAYMENT WILL BE MADE BY CODE

N/A

PROGRAM SUPPORT CENTER

FINANCIAL MANAGEMENT SERVICE

ROOM 16-A12

5600 FISHERS LANE

ROCKVILLE, MD 20857

FORMCHECKBOX

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

FORMCHECKBOX

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

Title: CONTRACT RESEARCH ORGANIZATION

(CRO) SERVICES FOR SAFETY AND

TOXICOLOGY STUDIES

For blocks (19) – (24), see Article 1.0, Addendum to Continue Blocks of SF 1449.

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

SEE ORDERS

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

FORMCHECKBOX

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA FORMCHECKBOX

ARE FORMCHECKBOX

ARE NOT ATTACHED.

FORMCHECKBOX

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA FORMCHECKBOX

ARE FORMCHECKBOX

ARE NOT ATTACHED.

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28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN [SEE ARTICLE 1.0] 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.

FORMCHECKBOX

29.

AWARD OF CONTRACT: REFERENCE ____________________ OFFER

DATED _________________. YOUR OFFER ON SOLICITATION (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

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

30c. DATE SIGNED

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

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 1449 (REV. 3/2005)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

Computer Generated

RFQ-BARDA-08-17

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED FORMCHECKBOX

INSPECTED FORMCHECKBOX

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:______________________________________________

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GAOVERNMENT REPRESENTATIVE

33. SHIP NUMBER

34. VOUCHER NUMBER

35. AMOUNT VERIFIED CORRECT FOR

36. PAYMENT

COMPLETE FORMCHECKBOX

PARTIAL FORMCHECKBOX

FINAL

37 CHECK NUMBER

FORMCHECKBOX

PARTIAL FORMCHECKBOX

FINAL

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

40. PAID BY

42b. RECEIVED AT (Location)

Computer Generated

STANDARD FORM 1449 (REV. 3/2005) BACK

ARTICLE 1.0

Addendum to Continue Blocks of SF 1449

1.1. Block (7). Government Contact Point: From the date of RFQ issuance through the date of contract award, Quoters shall direct all communications concerning this acquisition by writing via email or postal mail to the attention of the contact point set forth therein. Communications with any other Government official regarding this acquisition is strictly prohibited and may disqualify your quotation from further consideration.

1.2. Block (8). Closing Response Date and Time: All quotations will be received at the Issuing Office address set forth in Block 9 until the date and time specified in Block 8. Time is of the essence for the proper receipt of quotations. Quotations received after the closing response date and time may not be considered for award. All submitted quotations shall be marked on the package wrapper with the solicitation number of Block 5 and to the attention of the person in Block 7(a).

1.3. Block (10). Set-Aside Status: This solicitation is not set-aside for any specific class of quoters. The NAICS Code applicable to this solicitation is 325414, Biological Product (except Diagnostic) Manufacturing. The small business size standard is 500 employees. The quoter shall use this information to complete the Representations and Certifications set forth in the provision FAR 52.212-3, Offeror Representations and Certifications—Commercial Items.

1.4. Blocks (11), (15). Delivery: The date(s) and place(s) of delivery, inspection, acceptance, and FOB point will be set forth in the individual order(s) issued hereunder. In the absence thereof, the place will be Block (16).

1.5. Block (18b). Invoices: Invoices and all invoice-related correspondence shall be submitted to the address designated in Block (16) for processing; do not submit documents directly to the address in Block (18a). Invoices shall cite the Contract Number and the Task Order Number for each order for which payment is being requested. All payments by the Government under this contract will be made by electronic funds transfer (EFT). The Contractor shall submit its EFT banking information on the attached Payment Information Form. See Article 5.0, infra. The Contractor shall include its Taxpayer Identification Number (TIN) and its Dun & Bradstreet Data Universal Numbering System (DUNS) Number on all invoices.

1.6. Blocks (19) – (24). The Schedule: This is a solicitation issued as a request for quotations (RFQ) for the acquisition of commercial items using simplified acquisition procedures pursuant to FAR Parts 12 and 13, respectively. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-24 effective on February 28, 2008.

1.6.1 Disclaimer. It is understood that any information provided pursuant to this solicitation will not be the basis for any claim against the U.S. Government, nor shall any cost incurred in so providing be reimbursed by the U.S. Government, unless such reimbursement is the subject of an express agreement or is allowed under the cost principles set forth in FAR Part 31. It is further understood that any submission will be retained by the U.S. Government and will not be returned to the provider. All submissions will become part of the official solicitation file and will be maintained in accordance with applicable law.

1.6.2 This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for safety and toxicology studies. During the ordering period of the contract, contracting officers assigned to the office in Block (16) may order supplies and services at the contract prices, or may request the Contractor to propose a price that will not exceed the contract prices.

1.6.3 Contract Minimum and Maximum Quantity. Pursuant to FAR 52.216-22(b), Indefinite Quantity (Oct 1995), the quantities designated as the contract “minimum” and “maximum” are as follows:

(a) Minimum: $5,000.00. The contract “minimum” applies to the base ordering period only; the Government does not guarantee a minimum quantity for any option year period.

(b) Maximum: $5,000,000.00. The contract “maximum” is cumulative over and inclusive of all ordering periods, if exercised.

1.6.4 Pricing Arrangements of Orders. Orders issued hereunder will either be priced on a (1) time-and-materials or labor-hour basis, or a (2) firm-fixed-price basis. The specific pricing arrangement will be identified in each individual order.

1.6.5 Contract Items and Prices. A list of all services and supplies to be quoted under this solicitation are contained in Exhibit A, Supplies or Services and Prices/Costs. Exhibit A, Supplies or Services and Prices/Costs is hereby attached to and made a part of this solicitation with the same legal effect as if repeated herein as full-text. See Article 5.0, infra.

1.6.6 Description of Requirements for Contract Items. A description of the requirements for the items to be quoted under this solicitation is contained in Attachment One (1), Scope of Work. Attachment One (1), Scope of Work is hereby attached to and made a part of this solicitation with the same legal effect as if repeated herein as full-text. See Article 5.0, infra.

1.7. Block (28). Quotations: All quotations shall be submitted via postal mail or private delivery service such as FedEx/DHL/UPS or similar, in an original, three (3) additional hard-copies, and one electronic copy on a CD-ROM or USB drive. Submission via courier service or hand-carrying is permissible, but must be coordinated in advance with the Government Contact Point. Quoters or delivery agents shall be required to present a government-issued proof of identity for delivery of quotations.

ARTICLE 2.0

Addendum to FAR 52.212-4, Contract Terms and Conditions - Commercial Items (Feb 2007)

2.1. The clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Items (Feb 2007), has been incorporated by reference herein, see Block 27 of SF 1449, supra, and will apply to orders priced on a basis other than time-and-materials or labor-hour. This clause with its Alternate I (Feb 2007) is hereby incorporated by reference herein, and will apply to orders priced on the basis of time-and-materials or labor-hour.

2.2. Paragraph (c) of FAR 52.212-4, Contract Terms and Conditions—Commercial Items (Feb 2007) is hereby tailored by addition of the following language, “The Government will issue all administrative changes by unilateral modification.”

ARTICLE 3.0

FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (Feb 2008)

3.1. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Feb 2008), is hereby incorporated by reference herein.

3.2. Insert a check mark in paragraph (b) of FAR 52.212-5 to items (1), (16)-(24), (28), (31), and (36).

ARTICLE 4.0

Addendum to Include Additional Contract Terms and Conditions

4.1. The following solicitation provisions and contract clauses pertinent to this Article are hereby incorporated by reference herein.

Clauses Incorporated By Reference (FAR 52.252-2) (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 these addresses: FAR available at http://www.acquisition.gov/; http://farsite.hill.af.mil/VFFARa.htm;

HHSAR available at http://www.knownet.hhs.gov/acquisition/hhsar/default.htm.

In paragraph (a), insert “the date of contract award” and “end of applicable ordering period. See Schedule.”

In paragraph (a), insert “$10,000”; in paragraph (b), insert in subparagraphs (1) and (2) “the amount in the Schedule of the contract maximum”, and in subparagraph (3) “30”; in paragraph (d), insert “30.”

Insert “the date of contract award plus five (5) years.”

Insert “30 days after expiration of an ordering period.”

Insert in paragraph (a), 1st insert “30 days after expiration of an ordering period”, 2nd insert “30”, and in paragraph (c) insert “four (4) years.”

4.2. Care of Live Vertebrate Animals (HHSAR 352.270-9(b)) (January 2006)

(a) Before undertaking performance of any contract involving animal related activities the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care and use of any live vertebrate animals used or intended for use in the performance of this contract will conform with the PHS Policy on Humane Care of Use of Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall be used.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved PHS Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.

4.3. Information on Compliance with Animal Care Requirements.

(a) Registration with the U. S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. The USDA office contact information is available at http://www.aphis.usda.gov/ac/acorg.html. They are responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et seq.), available at http://www.nal.usda.gov/awic/legislat/awa.htm.

(b) The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW), available at http://grants2.nih.gov/grants/olaw/olaw.htm. An essential requirement of the PHS Policy, available at http://grants2.nih.gov/grants/olaw/references/phspol.htm, is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.

(c) The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals, available at http://www.nap.edu/readingroom/books/labrats, and that they comply with the regulations (9 CFR, Subchapter A), available at http://www.nal.usda.gov/awic/legislat/usdaleg1.htm, issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act.

(d) The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), available at http://www.aaalac.org, is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the Accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federated of Animal Science Societies, available at http://www.fass.org.

4.4. Laboratory Standards. The Contractor shall maintain its ability to handle infectious biological agents in a fully-equipped, secured facility, including compliance with Biosafety Level 2+ containment, ISO 9001 certification, all applicable requirements of the Good Laboratory Practices regulation (21 C.F.R. Part 58), and use assays recognized by the U.S. Food and Drug Administration.

4.5. Manufacturing Standards. The Contractor shall comply with all applicable requirements of the Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) and regulations pertaining to biological products (21 CFR Part 600) in the manufacturing, processing, packaging, storage and delivery of any product.

4.6. Reporting Matters Involving Fraud, Waste, and Abuse. Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in DHHS funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov.

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, DC 20026

4.7. Confidentiality of Information. The Government has determined that this contract involves access to, and creation, distribution, and use of, sensitive information, confidential business information, and other non-public information. Non-public information is information/data/material that is known, or reasonably should be known, not to have been made available to the general public; examples include information/data/material that is (1) routinely exempt from disclosure under 5 U.S.C. 552 or otherwise protected from disclosure by statute, Executive order or regulation; (2) is designated as non-public by any government agency; or (3) has not actually been disseminated to the general public and is not authorized to be made available to the public on request. The Contractor shall guarantee strict confidentiality of such information/data/material, and shall not release, publicize, or make known such information/data/material in any manner. Further, the contractor agrees to use such information/data only under the following conditions:

(a) The Contractor and Contractor's employees shall: (i) use the information/data/material only for the purposes of carrying out the work required by the contract; (ii) not disclose the information/data/material to anyone other than the contracting officer, or his duly appointed project officer(s); and (iii) return the information/data/material whenever the information/data/material is no longer required by the Contractor for performance and upon completion of the contract.

(b) The Contractor shall obtain a written agreement to honor the limitations herein from each of the Contractor's employees who will have access to the information before the employee is allowed access.

(c) The Contractor agrees that these contract conditions concerning the use and disclosure of such information/data/material are included for the benefit of, and shall be enforceable by, the Government and any affected person, business, or organization having a proprietary interest in the information/data/material.

(d) The Contractor shall not use any such information/data/material to compete with any person, business, or organization having a proprietary interest in the information/data/material to which such information/data/material relates.

(e) The Contractor agrees to obtain the written consent of the contracting officer prior to entering into any subcontract that will involve the disclosure of such information/data/material by the Contractor to the subcontractor.

(f) The Contractor shall submit any request for waiver of this provision to the Contracting officer. Disclosure of any such information/data/material, in whole or in part, by the Contractor shall only be made after receipt of prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data/material under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

(g) If a contractor, through an employee or otherwise, is subpoenaed to testify or produce documents, or to disseminate any information/data/material to comply with any law, rule, regulation, court ruling or similar order, which could result in disclosure of such information/data/material, then the Contractor must provide immediate advance notification to the contracting officer so that the Government may authorize such disclosure, or have the opportunity to take action to prevent such disclosure.

(h) The Contractor agrees that this provision is a material part of this contract and that any disclosure of such information/data/material is in violation of this contract and maybe a violation of applicable law. Remedies for noncompliance herewith include default, or other contractual actions, as well as civil or criminal remedies authorized by law.

4.8. Notice prior to publication. The Contractor shall not release any reports, manuscripts, press releases, or abstracts about this contract, orders, or work being performed thereunder without advance written notice to and approval by the contracting officer.

4.9. Conflict of Interest. The Contractor warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the contracting officer (CO) immediately that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the CO any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall immediately make a full disclosure in writing to the CO. This disclosure shall include a description of actions, which the Contractor has taken or proposes to take, after consultation with the CO, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the CO of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the CO deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the CO, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

4.10. Working Files. The Contractor shall maintain accurate working files on all work documentation including calculations, assumptions, interpretations of regulations, sources of information, and other raw data required in the performance of this contract. The Contractor shall provide the information contained in its working files upon request of the Contracting Officer.

4.11. Identification and Disposition of Data. The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

4.12. Contracting Officer. 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. 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. No presumption exists that the contracting officer has knowledge of information provided to any person other than directly to him. Information or direction received by the contractor from any person other than the contracting officer does not relieve the contractor from any contractual requirement or change any term or condition thereof. In the absence of written notice to the contrary, the contracting officer will be the sole official responsible for acceptance of any service or supply delivered to the Government hereunder. At his discretion, and subject to limitations prescribed by him, the Contracting Officer may appoint a Project Officer to assist in contract administration. The Contracting Officer reserves his right to contravene any information provided by the Project Officer. See Article, infra entitled Project Officer.

4.13. Project Officer. Performance of the work hereunder shall be subject to the technical directions of the Contracting Officer and, if applicable, the duly appointed Project Officer to this contract. A separate Task Order Project Officer may be appointed to each order hereunder; a task order project officer is authorized to provide technical direction for his cognizant task order only, subject to the limitations set forth below. The authority of Project Officer is subject to the limitations prescribed by the Contracting Officer.

(a) As used herein, technical directions are directions to the Contractor which fill in details, suggest possible lines of inquiry, or otherwise completes the general scope of work set forth in the contract and/or orders issued under the contract. 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 or order (1) price/cost, (2) schedule, or (3) quality of performance, including 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. Technical direction(s) will be issued in writing or confirmed in writing within five (5) calendar days after verbal issuance by the contracting officer, or his duly appointed project officer(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

(b) 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 proper written modification(s) to the contract.

(c) The Government will provide the Contractor with a copy of the appointment memorandum for the Project Officer(s). Any changes in Project Officer Appointment will be made by the Contracting Officer in writing with a copy being furnished to the Contractor. Notwithstanding any indication to the contrary, the actual authority of the project officer is strictly subject to the limitations contained in his Appointment letter.

4.14. Contract Communications/Correspondence. The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

4.15. Contractor Performance Evaluations. The contracting officer will complete a Contractor Performance Report in accordance with FAR Subpart 42.15—Contractor Performance Information. The contractor will be evaluated in accordance with the attached Contractor Performance Report. See Article 5.0, infra.

4.16. Ordering Periods: The “term of the contract” set forth in FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000), and the period of “performance” set forth in FAR 52.217-8, Option to Extend Services (Nov 1999), specify the contract ordering periods. The Government has the option to extend the ordering period of this contract for three (3) additional periods. The contract ordering periods consist of one base period and three option periods as follows:

(a) Base Period: Contract award through contract award plus one year.

(b) Option Period One (1): Contract award plus one year through contract award plus two years.

(c) Option Period Two (2): Contract award plus two years through contract award plus three years.

(d) Option Period Three (3): Contract award plus three years through contract award plus four years.

4.17. Delivery Period: The Contractor shall accomplish performance of an order issued hereunder no later than 12 months after the issue date of such order, unless an alternate performance period is mutually agreed between the Government and Contractor.

4.18. Fair Opportunity Ordering. Subject to FAR § 16.505, Ordering, the following procedures will be used to issue orders hereunder.

4.18.1 SEQ CHAPTER \h \r 1All work under this contract will be ordered through the issuance of written "Task Order(s)" on an Optional Form 347 signed by the contracting officer. The contracting officer is the only individual authorized to award a Task Order under this contract. The contractor shall only commence work upon receipt of a written Task Order award executed by the contracting officer.

4.18.2 For orders exceeding the micro-purchase threshold, see FAR § 2.101, at the time of the order placement, and subject to the exceptions to the fair opportunity process, see FAR § 16.505(b)(2), the Government will place an order with the contract-holder that provides the greatest overall benefit to the Government upon consideration of factors pertinent to an individual order.

4.18.3 Fair opportunity to be considered for each order will be accomplished by one, or a combination of, the following order placement procedures.

4.18.3.1. In accordance with FAR 16.505(b)(1), the contracting officer will provide each awardee a fair opportunity to be considered for each order exceeding $3,000 issued under multiple task order contracts by issuing a Task Order Request (TOR) to each contract-holder. The contracting officer may issue a TOR to fewer than all contract-holders upon a determination that one of the exceptions to the fair opportunity process described in FAR 16.505(b)(2) applies. A TOR will be issued either verbally by the contracting officer, or in a written format that has been executed by the contracting officer. A review pursuant to this subparagraph will be deemed adequate for fair opportunity consideration.

(a) A TOR may provide a Statement of Work, order-specific factors to be used in the selection decision, reporting requirements, deliverables and delivery schedule, and any special instructions or terms applicable to the order.

(b) Selection factors for award will be specific for each individual order.

(c) A TOR will request a written proposal and/or an oral presentation to be prepared and submitted by the contract-holder to the contracting officer. The contracting officer will use the TOR proposal as one basis, or the sole basis, for the order placement decision. The TOR will set forth the specific requirements for the proposal. Information that may be requested includes, but is not limited to, an approach to perform the work, technical and managerial resources, schedule for performance identifying major milestones, conflict-of-interest certification, and a price itemized by price elements.

(d) Unless otherwise specified in a TOR, a contract-holder shall prepare and deliver a proposal within seven (7) calendar days of receipt of the TOR to the contracting officer for consideration.

4.18.4 Orders placed hereunder will be executed on an OF 347 and will, at a minimum, contain the following information:

(a) Date of order.

(b) Contract number and order number.

(c) Description of services, contract item number(s) and description, quantity, and price.

(d) Delivery or performance schedule.

(e) Place of delivery or performance (including consignee).

(f) Any packaging, packing, and shipping instructions.

(g) Accounting and appropriation data.

(h) Delegation of a Task Order Project Officer, if applicable.

4.18.5 The name, address, telephone number, facsimile number and e-mail address of the agency task and delivery order ombudsman will be included at contract award

ARTICLE 5.0

List of Documents, Exhibits, and Other Attachments.

5.1. The following items are attached to and made a part of this contract/solicitation:

Identifier Title

Date

Number of Pages

Exhibit A Supplies or Services and Prices/Costs n/a

Attachment

One (1) Scope of Work

Two (2) Payment Information Form

Three (3) Contractor Performance Report

ARTICLE 6.0 Addendum to FAR 52.212-1, Instructions to Offerors—Commercial Items (Nov 2007)

6.1. The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items (Nov 2007), has been incorporated by reference herein, see Block 27 of SF 1449, supra.

6.2. Paragraph (b)(4) of FAR 52.212-1 is hereby tailored by inserting at the end of the sentence, “Quoters shall identify the portions of their quotations that are pertinent to each evaluation criterion; this may be accomplished, among other reasonable means, by a cross-reference table or arrangement of sections within the quotation.

6.3. Paragraph (b)(6) of FAR 52.212-1 is hereby tailored by inserting at the end of the sentence, “In accordance with the terms and conditions of this solicitation, and Exhibit A, Supplies or Services and Prices/Costs, all proposals shall provide a pricing table including items, units of measure, time for delivery after receipt of order, and prices for all supplies and services that may be necessary to perform any order issued hereunder within the Scope of Work, see Solicitation, Article 5.0, Attachment 1. All items shall be defined and/or described (e.g., a labor category definition in terms of function and requirements; service definition in terms of tasks performed). Items and prices shall be proposed for the base ordering period and each of the three optional ordering periods, for a total of four ordering periods. The Government intends to establish all items and all prices at the time of contract award that may be necessary to perform any order issued under the contract; therefore, it is imperative that quoters submit all pricing information with their initial quotation. Failure to submit adequate pricing information may result in rejection of your quotation.”

6.4. Paragraph (b)(10) of FAR 52.212-1 is hereby tailored by inserting at the end of the sentence, “For submission of past performance information, the following apply: ‘Recent contracts’ are defined as contracts completed within the past two years, or are ongoing and begun more than six months ago. ‘Relevant contracts’ are defined as contracts similar in value, quantity, type, scope, and duration hereto. The number of contract references submitted shall not exceed three (3).”

6.5. FAR 52.212-1 is hereby tailored by addition of the following paragraphs.

6.5.1 Solicitation Provisions Incorporated by Reference (FAR 52.252-1) (Feb 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

FAR available at http://www.acquisition.gov/; http://farsite.hill.af.mil/VFFARa.htm;

HHSAR available at http://www.knownet.hhs.gov/acquisition/hhsar/default.htm.

6.5.2 Type of Contract FAR (52.216-1) (Apr 1984).

The Government contemplates award of an indefinite-delivery, indefinite-quantity (IDIQ) contract resulting from this solicitation.

6.5.3 All inquiries concerning the solicitation document shall be submitted in writing, and should be received by the Government Contact Point via email or at the address in Block (9), SF 1449, no later than two business days prior to the Closing Response Date and Time. See Article 1.0, supra.

6.5.4 Quoters are cautioned that any answers to questions furnished to quoters will not amend the solicitation per se. Amendments will be expressly marked as such. It is incumbent on quoters to seek clarification from the contracting officer if they believe an answer, or any other information, to be inconsistent with the solicitation.

6.5.5 Any additions, deletions, or changes to the solicitation will be effected by the contracting officer by written amendment only.

6.5.6 Electronic or facsimile submission of quotations is not authorized.

6.5.7 Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (HHSAR 352.270-9(a)) (January 2006).

The PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions establishes a number of requirements for research activities involving animals. Before award may be made to an applicant organization, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance which commits the organization to comply with the provisions of the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources. In accordance with the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities and procedures. No award involving the use of animals shall be made unless OLAW approves the Animal Welfare Assurance. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The Contracting Officer will request that OLAW negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, contact OLAW at NIH, Bethesda, Maryland 20892 (301–496–7163).

ARTICLE 7.0

Streamlined Evaluation of Offers

7.1. The provision at FAR 52.212-2, Evaluation—Commercial Items (Jan 1999) does not apply to this acquisition. In lieu thereof, and pursuant to FAR § 12.602 and FAR § 13.106, the Government will evaluate quotations pursuant to the procedures and evaluation criteria set forth herein.

7.2. All timely-submitted quotations will be considered. In order to evaluate quotations in an efficient and minimally burdensome fashion, the Government reserves the right not to score or rank the quotations received and to make a source selection without exchanges with quoters; therefore, quoters are encouraged to submit their most favorable terms in initial quotations.

7.3. The Government reserves the right to conduct announced pre-award site-inspection(s) of any facility proposed by the quoter for use in performance of the contract. The purpose of the site-inspection(s) will be to supplement the Government’s evaluation of the written quotation. The results of any site-inspection(s) will be incorporated in the overall evaluation of the quotation for use in the source selection decision. By submission of a quotation, a quoter offers approval and consent to such site-inspection(s) deemed appropriate by the Government.

7.4. Contract award will be made to the responsible quoter(s) whose quotation conforms to this solicitation and provides an overall “best value”, as defined in FAR § 2.101, to the Government based on the evaluation of quotations against the evaluation criteria set forth herein.

7.5. Evaluation Criteria. (listed in relevance of importance)

7.5.1 Technical Ability (Non-price Factor). The Government will evaluate the quoter’s demonstrated capability to complete all activities identified in the statement of work.

7.5.2 Past Performance (Non-price Factor). The Government will assess the performance risk of each quotation. Performance risk will be measured in a subjective evaluation of the probability of future successful performance based on a record of recent and relevant past performance. The lack of a recent or relevant performance record may result in an unknown performance risk assessment identified as “No relevant past performance history identifiable”, which will neither be used to the advantage nor disadvantage of the quoter. At its discretion, the Government may not contact every reference provided by the quoter, may contact additional references other than those identified by the quoter, or use any other reasonable basis of past performance for evaluation of performance risk of each quotation.

7.5.3 Facility (Non-price Factor). The Government will evaluate the demonstrated capability of the quoter to provide facilities, equipment, and systems that are adequate and in the proper condition to successfully perform the contract. The quoter must demonstrate an ability to handle infectious biological agents in a fully-equipped, secured facility with Biosafety Level 2+ containment, ISO 9001 certification, current Good Manufacturing Practices (21C.F.R. Parts 210-211), and use of assays recognized by the U.S. Food and Drug Administration.

7.5.4 Price. The Government will evaluate the quoted prices to determine price reasonableness and realism. The Government may use various price analysis and price realism techniques on the proposed prices in order to determine fair and reasonable and realistic pricing. As applicable, the evaluated price will be inclusive of transportation charges from the shipping point of the supplier to the delivery destination. The evaluated price will be calculated by adding the total price for all options to the total price for the basic requirement; the Government may determine that a quotation is unacceptable if the option prices are significantly unbalanced.

7.5.5 Compliance with Good Laboratory Practices Requirements (Non-price Factor). The Government will evaluate the quoter’s compliance with Good Laboratory Practices (21 C.F.R. Part 58).

7.5.6 Quality Systems (Non-price Factor). The Government will evaluate the quoter’s demonstrated capability of its internal quality control and external quality assurance systems.

7.5.7 Animal Welfare (Non-price Factor). The Government will evaluate the quoter’s demonstrated compliance with applicable laws and policies for the housing and care of laboratory animals. The quoter must demonstrate accreditations from applicable local, state, and federal agencies to perform animal testing.

ARTICLE 8.0

FAR 52.212-3, Offeror Representations and Certifications—Commercial Items (Nov 2007)

8.1. The clause at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items (Nov 2007), is hereby incorporated by reference herein.

8.2. Quoters shall follow the instructions of FAR 52.212-3 to complete all applicable requirements. Quoters shall furnish a completed full-text copy of their Representations and Certifications as a part of their quotation.

Exhibit A

Supplies or Services and Prices/Costs Exhibit A

Supplies or Services and Prices/Costs

ARTICLE A.1.0

Brief description of supplies or services

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for services and related supplies to conduct pre-clinical animal safety and toxicology studies. During the ordering period of the contract, contracting officers assigned to the office in Block 16 of the SF 1449 may order services or supplies at the ceiling prices herein, or may request the contractor to propose a price that will not exceed the ceiling prices.

A.1.1. The Government will issue all orders under the contract on a firm-fixed price basis or a time and materials/labor hour basis with a not-to-exceed price.

A.1.2. The contract-holder shall only incorporate the items and prices set forth herein to develop its performance approach and price proposal in response to a Task Order Request, see Solicitation, Article 4.0.

A.1.3. While it is the Government’s intent to establish all items and all prices at the time of contract award that may be necessary to perform any order issued within the Scope of Work, see Solicitation, Article 5.0, Attachment 1, the Government recognizes that in extraordinary circumstances, an order may require specialized item(s) that were not foreseen during contract negotiations and thus are not listed in the Contract Price List, see Article A.2.0, infra. Costs/Prices for any such specialized items shall be separately identified in an order proposal, shall be based upon documented prices/costs and such documentation shall be provided with the proposal, will be evaluated pursuant to the policies and methods in FAR Subpart 15.4, and will be subject to negotiation. The Government may reject a proposal containing such items at its discretion, if the Government deems such rejection to be in its best interests.

ARTICLE A.2.0

Contract Price List

CLIN

Item

Unit Time for Delivery Ceiling Price [For example, Base Period:

Labor Category

A001 Scientist I

Hr

$100.00 A002 Technician III

$ 80.00 Option Period I:

Supply Item

A101 Towel

$ 1.00

Fixed Rate for Service

A102 Assay I test 3 days ARO

$500.00]

ATTACHMENT ONE (1)

SCOPE OF WORK

SCOPE OF WORK

FOR AN INDEFINITE DELIVERY / INDEFINITE QUANTITY CONTRACT FOR PERFORMANCE OF SAFETY AND TOXICOLOGY TESTING OF MEDICAL COUNTERMEASURES

1.0 Purpose

The purpose of this contract is to acquire the services and related supplies of a contract research organization to conduct pre-clinical animal safety and toxicology studies on animals through issuance of orders. The results of toxicological studies may be submitted to the Food and Drug Administration (FDA) in support of Investigational New Drug (IND) applications.

2.0 Scope

This document establishes the entire scope of work for performance under this indefinite delivery/indefinite quantity contract. Individual task orders issued hereunder will furnish the specific statements of work or specifications, within the scope of work established herein, that the contractor shall execute. Subject to the minimum quantity established in the Schedule, the Government will be obligated and the contractor shall perform only to the extent that set forth in individual orders.

3.0 Background

The National Strategy for Pandemic Influenza (November 2005) designated the Department of Health and Human Services (HHS) as the lead agency for public health preparedness and medical response to a probable or actual influenza pandemic.

The Pandemic and All-Hazards Preparedness Act of December 2006 established the Office of the Biomedical Advanced Research and Development Authority (BARDA) in the Department of Health and Human Services, to, in pertinent part, facilitate the research,…