Preclinical Development Support NIAID DAIDS NIHAI2010098.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692, as amended

2. Request for Proposal (RFP) Number:

NIAID-DAIDS-NIHAI2010098

3. Issue Date:

September 1, 2010

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : NIAID PRECLINICAL DEVELOPMENT SUPPORT

6. ISSUED BY:

Office of Acquisitions Division of Extramural Activities National Institute of Allergy Infectious Diseases National Institutes of Health Department of Health and Human Services 6700B Rockledge Drive, Room 3214 MSC 7612 Bethesda, Maryland 20892-7612 If using overnight delivery, use 20817

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 p.m. local time on November 30, 2010. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO TWO DIFFERENT LOCATIONS.

THE OFFICIAL POINT OF RECEIPT FOR THE PURPOSE OF DETERMINING TIMELY DELIVERY IS

THE ADDRESS PROVIDED FOR THE OFFICE OF ACQUISITIONS AS STATED IN ATTACHMENT 1,

"PACKAGING AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE

OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH

SUBPARAGRAPH (c)(3) OF FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTIONS TO OFFERORS-

COMPETITIVE ACQUISTION" LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

11. FOR INFORMATION CALL: Kishan Patel

PHONE: 301-496-0612

e-MAIL: patelki@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Michelle L. Scala Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases http://www.ccr.gov http://www.ccr.gov

RFP Number : NIAID-DAIDS-NIHAI2010098

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Conflicting Interests of Investigators

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12. Past Performance Information

13. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

Research Involving Recombinant DNA Molecules (including Human Gene Transfer Research)

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

7. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation in Fiscal Year 2009

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. Live Vertebrate Animals Evaluation

4. EVALUATION OF OPTIONS

5. EVALUATION OF DATA SHARING PLAN

6. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

7. TECHNICAL EVALUATION CRITERIA

8. PAST PERFORMANCE FACTOR

9. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide preclinical development support for promising candidates when such candidates emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing.

ARTICLE B.2. PRICES

a. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ (minimum) nor more than a total of $ (maximum) for successful performance of this contract.

FUNDED CONTRACT AMOUNT

Description Unit Funded Quantity

Unit Price ($) Period of Performance

Total Funded Amount ($)

b. The prices set forth in this ARTICLE B.2. will cover the contract period through .

c. Upon delivery and acceptance of the item(s) described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Item

Quantity (Units) Price Unit Price Total

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ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

The following Advanced Understandings are applicable to this acquisition and will be included in any resultant contract award:

1. Intellectual Property Option

The goal of this contract is to promote the development of critical biological materials and information by producing and in part evaluating various materials for anti-HIV immunogenicity (vaccine activity). For the purposes of this agreement, "material" includes compositions of matter, and associated information such as methods of making or using the compositions. It is expected that the great majority of materials will be proprietary, in part, to third parties. It is clear from the NIAID's experience that third party providers ("Provider") will not provide their proprietary material ("Material") without assurance that the intellectual property rights associated with their Materials will be protected. Accordingly, to encourage Providers to provide their Materials for production or evaluation under this contract the Contractor agrees to this Article, which requires the Contractor and its subcontractors to provide a research use license and a commercialization license option to Subject Inventions made under the contract to the Providers as follows:

The Contractor agrees to promptly notify the NIAID and the Provider in writing of any Subject Inventions of the Contractor, its principal investigator and/or any other employees or agents of the Contractor, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of work under this contract using a Provider's Material (hereinafter "Contractor Invention"). The notice shall inform the Provider(s) of its right to the option set forth herein. This may be accomplished by attaching a copy of this Article to the notice.

a. Single Provider

With respect to Contractor Inventions resulting from the use of Material provided by one Provider, the Contractor agrees to grant to the Provider:

(i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and

(ii) a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to any Contractor Invention on terms to be negotiated in good faith by the Provider and the Contractor, subject to the following conditions:

The Contractor will allow Provider three (3) months from the date the Contractor sends written notice to the Provider of the existence of a Contractor Invention (or such additional period as the Provider and the Contractor may agree) to notify the Contractor in writing, whether or not it wants to obtain an exclusive license to the Contractor Invention. If the Provider fails to notify the Contractor, in a timely fashion then the Contractor's obligation to offer Provider a license option with respect to that Contractor Invention will expire, and the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies. If the Contractor and the Provider fail to reach agreement within ninety (90) days, (or such additional period as the Provider and the Contractor may agree) on the terms for an exclusive license for a particular Contractor Invention, then for a period of six (6) months thereafter the Contractor will not offer to license that Contractor Invention to any third party on materially better terms than those last

- 6 -offered to the Provider without first offering such terms to the Provider, in which case the Contractor will offer the Provider a period of thirty (30) days in which the Provider can accept or reject the offer.

b. Multiple Providers

With respect to a Contractor Invention resulting from the use of Materials provided by multiple Providers, but which is an improvement only to a Material of a specific Provider, the Contractor agrees to grant to that Provider the rights described above in (a).

With respect to any Contractor Inventions resulting from the use of Material from multiple Providers, but that are not improvements to or specific to a single Material, the Contractor agrees to grant to each Provider who provided Material:

(i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and

(ii) a time-limited first option to negotiate a co-exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all such Contractor Inventions on terms to be negotiated in good faith by each Provider and the Contractor subject to the following conditions:

The Contractor will allow each Provider three (3) months from the time the Provider is sent written notice by the Contractor of the existence of a Contractor Invention (or such additional period as each Provider and the Contractor may agree) to notify the Contractor, in writing, whether or not the Provider wants to obtain a co-exclusive license to the Contractor Invention. If a Provider fails to notify the Contractor, in a timely fashion then Contractor's obligation to offer that Provider a license option with respect to that Contractor Invention will expire and the Contractor will continue to offer an option to a co-exclusive license to the other Providers as set forth herein. If there is a single other Provider, it shall be offered an option to an exclusive license as though it were a single Provider. If no Provider notifies the Contractor in a timely fashion the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies.

c. Provider Inventions

The Contractor agrees that notwithstanding anything herein to the contrary, any invention or discovery, whether patentable or not, which is not a Subject Invention as defined in 35 USC 201(e)1 but arises out of an intentional and unauthorized use or modification of the Provider's Material by the Contractor and/or any other employees or agents of the Contractor, will be the property of the Provider (hereinafter "Provider Invention"). The Contractor will promptly notify the Provider in writing of any such Provider Inventions and, at the Provider's request and expense, the Contractor will take such further action as necessary to ensure that the Provider shall have all right, title and interest in and to any such Provider Inventions and give Provider any assistance reasonably necessary to obtain patents (including causing the execution of any invention assignment or other documents). The NIAID recognizes that the Contractor may also be conducting other research using the Provider's Material under the authority of a separate agreement with the Provider during the term of this contract; any invention arising under such separate agreement will not be subject to the terms of this provision entitled, "Provider Inventions."

d. Protection of Proprietary Data

All Materials, data and other information supplied by the Provider or the Project Officer shall be assumed to be confidential unless specifically identified as not confidential in writing by the Project Officer. The Contractor agrees that its principal investigator and/or any other employees or agents of the Contractor will provide the data generated under this contract exclusively to the NIAID or if directed by the NIAID, to the Provider and the FDA or other appropriate Federal agency. The Contractor understands that the NIAID may need to negotiate individual agreements with the various Providers to obtain Materials and that the terms of the agreements may vary. The NIAID intends that these agreements will provide for the Contractor's right to publish results generated by the Contractor under this contract after a reasonable period of time to allow the Provider to file patent applications and to protect its proprietary information. The Contractor agrees to enter into material transfer agreements with Providers when required by the Providers

- 7 -as a condition for the Contractor to receive Materials. Such agreements shall reference this contract by contract number and shall be consistent with any agreement the NIAID has entered into with the Provider to obtain Materials. In the event the Contractor reasonably objects to the terms of the material transfer agreement, the Contractor shall promptly bring such objection to the attention of the Contracting Officer for an appropriate resolution.

135 USC 201(e): The term ''subject invention'' means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, That in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401(d)) must also occur during the period of contract performance.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated July 9, 2010, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In accordance with the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract, these reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/ index.html under "Helpful Resources."

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) one hard copies of these reports will be required as follows:

[ ] Monthly [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Information Security and Physical Access Reporting Requirements

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The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. (Reference subparagraph A.e.

of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Technical Representative (COTR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

1. New Employees who have or will have access to HHS Information systems or data:

Provide the name, position title, e-mail address, and phone number of the new employee.

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Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

2. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract.

All documentation shall be made available to the COTR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

e. Contractor - Employee Non-Disclosure Agreement(s)

The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/security/Nondisclosure.pdf .

(Reference subparagraph E.2.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/od under "Vendor Information and Documents."

3. Task Order Reports

Within 30 days of completion of each Task Order, the Contractor shall submit a copy of the Task Order report electronically to the COTR and the Contracting Officer. The Task Order Report should be factual and concise and consist of the following:

a. A title page containing:

1) contract number and title

2) subcontract number and title

3) period of performance being reported

4) contractor's name and address

5) date of submission

b. Reports shall include, but are not limited to the following information:

1) a report detailing the actions taken to achieve the Task Order

2) a report of all products, procedures and outcomes achieved

3) graphs and tables of data obtained

4) a detailed budget report with invoices and cost justifications related to completing the Task Order

5) other information as may be required by the COTR

If the Contractor becomes unable to deliver the reports or other deliverables here specified within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent effort in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefore at the address given below.

http://www.hhs.gov/od

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Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Office of Acquisitions

6700B Rockledge Drive

MSC 7612, Room 3214

Bethesda, Maryland 20892- 7612

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract.The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions 6700B Rockledge Drive MSC 7612, Room 3214 Bethesda, Maryland 20892- 7612

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer's Technical Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Preclinical Research and Development Branch Vaccine and Prevention Research Program National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services Bethesda, Maryland 20892-7612

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from August 29, 2011 through August 28, 2018.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule

(1) Task Order Reports see below Upon completion of each task order

(2) Transition Plan see below 8 months prior to the completion date of the contract

(3) Final Report see below On or before the completion date of the contract

(4) Annual Invention Utilization Report see below 30 calendar days after the anniversary date of each contract year

(5) Final Invention Report see below on or before the completion date of the contract.

(6) Section 508 Annual Report see below 30 calendar days after the anniversary date of each contract year

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity Contracting Officer 1, 2, 3, 4. 5, and 6 1 electronic and 1 hard copy Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases, NIH

6700-B Rockledge Drive, Room

3214, MSC7612

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Addressee Deliverable Item No Quantity Bethesda, MD 20892-7612

Contracting Officer's Technical Representative

1, 2 and 3 1 electronic and 1 hard copy

PRDB, VRP, Division of AIDS National Institute of Allergy and Infectious Diseases, NIH

6700 B Rockledge Drive, Room

5136, MSC 7628

Bethesda, MD 20892-7628

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

http://www.acquisition.gov/comp/far/index.html

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE (COTR)

The following Contracting Officer's Technical Representative (COTR) will represent the Government for the purpose of this contract:

To be named at time of award.

The COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COTR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

To be specified prior to award.

ARTICLE G.3. METHOD OF ORDERING

a. A Task/Delivery Order Number shall be given to you at the time the order is placed. The Contractor is cautioned not to accept an order unless one of these numbers is issued.

b. The Consignees/Ordering Officials shall sign all orders (including written confirmation of oral/telephonic orders) involving requests for supplies and/or services under this contract. Each delivery shall be accompanied by a packing slip or other evidence of delivery/performance.

The authorized designees are:

The following Contractor representative(s) is/are authorized to receive and accept orders placed by telephone:

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Name(s):

Telephone:

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health Room 3214 6700B Rockledge Drive MSC 7612

BETHESDA, MD 20892- 7612

E-Mail: NIAIDOAInvoices@niaid.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institutes of Allergy and Infectious DIseases .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices@niaid.nih.gov .

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c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract."

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at:

http://rcb.cancer.gov/rcb-internet/reference/Appendix Q_HHS Contracting Guide.pdf.

http://rcb.cancer.gov/rcb-internet/reference/Appendix%20Q_HHS%20Contracting%20Guide.pdf

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ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually to coincide with the anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

ARTICLE G.8 TASK ORDER PROCEDURES

In providing support under this contract, the Contractor shall initiate work by task order. A task order specifies and authorizes work to be accomplished by the Contractor to satisfy Government task requirements. Task orders issued under this contract will not be synopsized. All work required under this contract shall be authorized through execution of an agreement, "Task Order," signed by the Contractor and the Contracting Officer. Task Orders may be awarded at any time within the contract period. Task orders may be terminated for the convenience of the Government because the time or funds were exhausted, because the need no longer exists or has changed, or for cause. The Task order process is described in detail below.

The following types of Task Orders may be issued: Cost Reimbursement and Fixed Price

I. TASK ORDER REQUEST

The Government will issue the Task Order request to the Contractor for preparation of a proposal. A TOR shall, at a minimum, include a Statement of Work, specific reporting requirements, deliverables and delivery schedule, and any special instructions.

All work assigned under the contract shall relate directly to one or more of the task areas in the Statement of Work.

The TOR will also provide instructions for submission of responses to the TOR, stating what must be provided (detailed plan of approach, proposed personnel, budget, etc.). If necessary, the Contracting Officer shall arrange a meeting between the Contractor and members of the sponsoring office to discuss the proposed Task Order prior to submitting a Task Order proposal. Budgets shall include appropriate support for all costs proposed as necessary for performing the task. Task Order proposals shall generally be limited to twenty (20) pages, including attachments.

II. TASK ORDER PROPOSAL

The Task Order request doesn't commit the Government to pay any costs incurred in the submission of any proposal, nor does it commit the Government to issue a Task Order for such services. The Government intends for each Task Order request to be negotiated into a resulting Task Order; however, there is no guarantee that a Task Order will be issued in every case.

http://oamp.od.nih.gov/OD/CPS/cps.asp

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Within the time allowed for proposal preparation (time allowed for proposal preparation and submission will vary depending on the task and will be designated in each TOR), the Contractor shall submit their proposals in response to a TOR, that shall include, but not necessarily be limited to the following information:

(1) Proposed Budget

a. Personnel - The Contractor shall propose specific labor categories and skill mix and explain how the resources it intends to allocate will assure that the deliverables/schedule will be met. Resumes of Key Personnel shall be provided. The Contractor shall provide individuals who are qualified and capable of performing the required Task Order.

b. Materials and Supplies

c. Travel

d. Consultants

e. Subcontracts

f. Other Direct Costs

(2) Technical Approach - A narrative description of the Contractor's understanding of the requirement and proposed technical approach. The Contractor shall identify any problems and propose solutions in order to satisfy the Task Order requirement.

(3) Deliverables - A list of deliverables required for the Task Order.

III. NEGOTIATION AND TASK ORDER ISSUANCE

The Government will evaluate proposals and conduct negotiations as necessary. Task Orders will be awarded once a determination has been made that the negotiated approach, personnel, and costs are the most advantageous to the Government. The Government reserves the right to make an award without discussion.

The Contracting Officer is the only individual authorized to issue TOR or award a Task Order under this contract.

Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work on a requirement until a fully executed Task Order has been awarded.

It is anticipated that Task Orders will be awarded within thirty (30) calendar days from receipt of Task Order proposals.

Each Task Order shall, at a minimum, contain the following information:

• Date of order

• Contract number and Task Order number sequentially

• Description of services and estimated cost

• Performance period

• Name and address of sponsoring office

• Name of Contracting Officer's Technical Representative

• Place of performance

• Packaging and shipping instructions, if any

• Accounting and appropriation data

• Pricing Arrangements

• Any other pertinent information

IV. TASK ORDER COMPLETION/CONCLUSION

(1) For each Task Order performed, the Contractor shall prepare Part III of the Task Order for submission to the Contracting Officer. Part III of the Task Order shall be submitted as soon as possible but no later than 3 months after the completion date of the Task Order. This Part III submission shall include all actual information (cost, effort, and deliverables) relative to the Task Order.

(2) After verification that all work is complete and deliverables have been received and accepted, the COTR will sign Part III of the Task Order to indicate recommendation for approval and forward the Task Order to the Contracting Officer for signature. After verification that the Task Order has been satisfactorily completed, the Contracting Officer will approve completion of the Task Order by signing Part III of the Task Order and forward it to the Contractor.

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene Transfer Research)

All research involving Recombinant DNA Molecules shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules ( http://oba.od.nih.gov/rdna/nih_guidelines_oba.html) and the September 24, 2007 Notice, "Reminder of NIH Policy for Enhancing the Science, Safety, and…