RFP-NIH-NIAID-DMID-AI2008041.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

NIH-NIAID-DMID-AI2008041

3. Issue Date:

October 15, 2008

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Animal Models of Infectious Diseases

6. ISSUED BY:

Brian Jamieson, Contract Specialist National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, MD 20892

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 4:00 pm local time on February 17, 2009. 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 HHSAR CLAUSE 352.215-70, ENTITLED, "LATE PROPOSALS, AND REVISIONS" 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: Brian Jamieson, Contract Specialist

PHONE: 301-451-3678

e-MAIL: bjamieson@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Yvette R. Brown, Contracting Officer

MID RCB-A, OA, NIAID, NIH

6700-B Rockledge Drive, Room 3214 Bethesda, MD 20892 http://www.ccr.gov http://www.ccr.gov

RFP Number : NIH-NIAID-DMID-AI2008041

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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. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

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. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Conflicting Interests of Investigators

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Electronic and Information Technology Accessibility

16. Prohibition on Contractor Involvement with Terrorist Activities

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Possession, Use and Transfer of Select Biological Agents or Toxins

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 2008

6. Small Business Subcontracting Plan

7. HUBZone Small Business Concerns

8. Extent of Small Disadvantaged Business Participation

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Representations and Certifications - SECTION K

15. Travel Costs/Travel Policy

16. Certification of Visas for Non-U.S. Citizens

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF DATA SHARING PLAN

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

4. TECHNICAL EVALUATION CRITERIA

5. PAST PERFORMANCE FACTOR

6. 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 Animal Models of Infectious Diseases program will provide NIAID with a broad and flexible range of animal model capabilities for human infectious diseases or diseases of human importance caused by infectious agents. The broad scope will allow NIAID to respond to changing priorities as scientific and public health needs shift, including rapid responses to public health emergencies. The scope of work encompasses all animal work needed for infectious disease research, to include new animal model development and refinement of existing models, routine screening of products, efficacy testing to support Investigational New Drug (IND) applications or clinical trials, and efficacy testing in support of Biologic License Application/New Drug Application (BLA/NDA) submissions to the FDA under Good Laboratory Practices (GLP, 21 CFR Part 58). Also included is the use of laboratory animals to generate pathogens and pathogen-specific reagents that are not commercially available but required for research or product development.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

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.

In addition, the following advance understandings are applicable to this solicitation:

a. CONFIDENTIALITY

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Maintaining confidentiality of information is crucial to the success of this program. There are two types of confidential information to be shared:

1. Proprietary data This information is related to the products being tested in animal models. Contractors will be bound to restrict access and disclosure of proprietary information that may be shared with them from third party submitters in order to conduct the animal studies. A sample Non-Clinical Evaluation Agreement to be signed by NIAID and the third party sponsor is found at Attachment 7.

2. Animal models developed through these contracts This information may be shared by NIAID with interested third parties and will be protected prior to publication as Confidential Information, under a separate Confidential Disclosure Agreement between NIAID and the third party(ies) as long as this is not in conflict with the NIH Model Organisms Sharing Policy.

b. PUBLICATIONS

NIAID encourages publication of animal model research as one means of sharing information with the scientific community. For animal models that are pivotal for FDA licensure of various products, animal models will be shared with FDA through final study report submissions to a NIAID held FDA Master File.

c. GLP COMPLIANCE

Task orders and studies conducted under Good Laboratory Practices as set forth in 21 CFR Part 58 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58), may be the subject of NIAID directed technical and/or compliance site visits and/or audits using NIAID consultants. Particular aspects of quality assurance or GLP compliance will be negotiated for each Task Order as necessary.

d. INTELLECTUAL PROPERTY

The NIAID plans to seek a deviation from FAR clause 52.227-11, Patent Rights-retention by the Contractor (Short Form) (June 1989). Pursuant to a Determination of Exceptional Circumstances (DEC) as required by FAR 27.303, the NIAID plans to modify clause at FAR 52.227-11, Patent Rights-retention by the Contractor (Short Form) (June 1989) to restrict the contractor's rights to subject inventions arising under the contract. Specifically, the contractor will be required to assign to the Government or, if deemed appropriate by the NIAID and subject to certain rights reserved to the Government, to a collaborating party designated by the Government the entire right, title and interest throughout the world to each subject invention, except to the extent that rights are retained by the Contractor under the Greater Rights Determination provision of the clause. The contractor may request greater rights to an identified invention, and the NIH will consider whether granting the requested rights will interfere with rights of the Government or any collaborating party or otherwise impede the ability of the Government or others to develop new candidates for therapies, disease prevention and diagnosis as useful for anti-pathogen discovery and development. Contractors are encouraged to request greater rights where inventions relate to technology outside NIAID's program and where the contractor has negotiated with a supplier of proprietary composition for the disposition of patent rights concerning a subject invention related to the composition.

Furthermore, the timing of data publication will need to be restricted to allow adequate time for patent applications to be filed on inventions arising from the contracts. This would be accomplished by a deviation from FAR clause 52.227-14, Rights in Data-General (June 1987). Specifically, although NIAID encourages the publication of articles on research results, FAR 52.227-14, Rights in Data- General (June 1987) will be narrowly modified to restrict the Contractor's right to use, release to others, reproduce, distribute, and publish data produced or used by the contractor in the performance of the contract or allow adequate time for the filing of patent applications and to protect data that will be submitted as part of a regulatory filing. NIAID will reserve the right to coordinate the timing of

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Because these clause deviations are not yet approved, their text is not available for publication.

However, it is NIAID's intention that the finalized versions of the deviated FAR clauses will be available before award of any contract resulting from this initiative. Instead, the aforementioned description of how these clause deviations will be practiced under the resultant contract is provided.

Potential Offerors are afforded an opportunity to comment on their understanding of what NIAID is planning and to identify what impact these deviations may have on their conduct of the work should they be awarded a contract. Responses should be provided, in writing, to the Point of Contact for this RFP. See the bottom of the front page of this RFP for the individual's name and contact information.

Comments should be provided within 30 days of the issue date of this RFP. Therefore, NIAID will consider this input and determine whether alternative courses of action may be necessary. Decisions regarding these deviations will be made in consideration of the outcomes of the NIAID request for a determination of exceptional circumstances.

Intellectual Property Option to be offered to the NIAID's Third Party Providers of Proprietary Material and Protection of Resultant Proprietary Data.

This Article must be Included in any subcontract for evaluation of material. The subcontractor shall then have all the obligations of the Contractor.

The goal of this contract is to promote the development of critical biological information by evaluating various materials for anti-microbial 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 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 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.

1. 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

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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 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.

2. 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.

3. 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."

4. 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

- 8 -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 must 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 confidentiality agreements with Providers when required by the Providers 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 confidentiality 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 September 2, 2008, 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 addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

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.]

The Contractor shall submit to the Contracting Officer and the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the Project Officer. These reports shall be brief and factual and prepared in accordance with the format described below and in accordance with the DELIVERIES ARTICLE in SECTION F.

All reports shall include a cover page prepared in accordance with the following format:

• Contract Number, Task Order Number (Designation) and Task Order Title

• Period of Performance Being Reported

• Contractor's Name and Address

• Author(s)

• Date of Submission

• Delivery Address

Regular Task Order Progress Reports will be required and the frequency will be specified in Task Order Reporting Requirements. These reports will be monthly, bimonthly, or quarterly. The only technical progress report associated with the base contract will be the Annual Report on Animal Models.

Monthly

A monthly report will be required if specified in the Task Order Reporting Requirements. This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

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Bimonthly

A bimonthly report will be required if specified in the Task Order Reporting Requirements. This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full two months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of two full calendar months.

Quarterly

A quarterly report will be required if specified in the Task Order Reporting Requirements. This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months.

Annually

This report shall provide an annual update of all the animal models to be made available through the contract. This update will be in the form of a table for each Part (A - D) awarded, and will include at a minimum, the following information:

• Host species/strain

• Pathogen and strain

• Route of challenge

• Challenge dose

• Primary endpoints

• Secondary endpoints

• An assessment of the development stage of the model, using an assessment tool to be provided by the Project Officer after award of the first Task Order

• Publications using this model.

Additional elements to be included in the Annual Report will be discussed with and approved by the Project Officer.

Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. An annual report will not be required for the period when the Final Report is due.

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.

3. Report on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each Annual Progress Report:

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a. Any changes in the use of the Select Agent or Toxin and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the Institutional Biosafety Committee (IBC) or equivalent body or institutional biosafety official.

b. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

i. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

ii. A description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent;

iii. The title and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

b. Other Reports/Deliverables

In addition to the above reports, the following are considered other reports and deliverables under this contract and will be identified in the Task Order Statement of Work. A listing is included in the DELIVERIES Article in

SECTION F.

1. Animal Models

Animal models and protocols developed or refined, including Technology Transfer Packages.

2. Assays

All assays, reagents and protocols developed under this contract, including Technology Transfer Packages.

3. Pathogens

Pathogens that were not obtained from a repository will be deposited in a centralized repository.

The Government reserves the right to share these pathogen strains with others. Master and/ or working banks will be deposited as appropriate, including procedures for propagation and characterization, strain provenance and history, and data supporting its use in animal studies.

4. All product(s) remaining from studies.

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

- 12 -support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040-A, 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 6700-B 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, the Project Officer is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Heath National Institute of Allergy and Infectious Diseases 6610 Rockledge Drive Bethesda, Maryland 20892

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 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. 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:

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:

a. Technical Progress Reports

Item Reports Recipients Delivery Schedule

1. Regular Task Order Progress Report

1 original to CO

1 elec. copy to PO and CO

Regular Task Order Progress Reports will be specified in the Task Order Reporting Requirements, typically monthly, bimonthly or quarterly. For monthly reports, the first report is due six weeks after Task Order award. Thereafter, each report is due on/before the 15 th of each month following each reporting period.

2. Annual Report 1 hard copy to PO

1 elec. copy to PO and CO

The first report is due on/before 12/31/2010. Thereafter, each report is due on/ before the 30 th of the month following each anniversary date of the contract.

3. Draft Final and Final Report and Summary of Salient Results

2 hard copies of Final to PO

1 elec. copy of Draft and Final to PO and CO

Draft Final Report is due 30 calendar days prior to the completion date of contract.

Final Report is due on/before the completion date of the contract.

b. Other Reports and Deliverables (Delivery Schedule)

Item Deliverables SOW Reference Recipient Delivery Schedule

1. Draft and Final Study, Qualification and Validation Protocols with SAP

General SOW, 1B 1 elec. copy to PO 15 calendar days prior to initiating each study.

2. Standard Operating Procedures (SOPs)

General SOW, 1B 1 elec. copy to PO 15 calendar days prior to initiating each study.

3. Draft and Final Study, Qualification and Validation Study Reports with Statistical Analyses (SA)

General SOW, 1E 1 elec. copy to PO

2 hard copies of Final to PO

Within 30 calendar days after completion of each study.

4. Animal Model Technology Transfer Package

General SOW, 4.A.1. Project Officer or designated third party

To be specified in Task Order Deliverables

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Item Deliverables SOW Reference Recipient Delivery Schedule

5. Assay Technology Transfer Package

General SOW, 4.A.2. Project Officer or designated third party

To be specified in Task Order Deliverables

6. Pathogen Technology Transfer Package

General SOW, 4.A.3. Project Officer or designated third party

To be specified in Task Order Deliverables

7. Pathogen(s) and Reagent(s)

General SOW, 4.B NIAID Repository or designated third party

To be specified in Task Order Deliverables

ARTICLE F.2. 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. PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this contract:

[to be specified in resultant contract(s)]

The Project Officer 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 Project Officer designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (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 in resultant contract(s)]

ARTICLE G.3. METHOD OF ORDERING

The Federal Acquisition Streamlining Act (FASA) requires that each awardee under a multiple award contract, such as the resultant base IDIQ contracts for the Animal Models of Infectious Diseases, be given a fair opportunity to be considered for each order in excess of $3,000, unless a statutory exception applies. Government Contracting Officers have broad discretion to determine how work will be issued to awardees under multiple award IDIQ contracts, provided the procedures and selection criteria to be used are included in the Request for Proposal(s) and resultant base IDIQ contracts and the procedures allow for consideration of all awardees. Please also be advised that allocation or "equitable distribution" of orders, or placing order ceilings (under which the total value of orders must stay for each contractor), is contrary to the intent of FASA.

Contractors that have received a base IDIQ contract award for Parts A, B, C, or D are only eligible to receive Task Orders for Task parts which they have been awarded. For example offerors that have received a base IDIQ contract award for Part A will only be eligible to receive Task Orders for Part A.

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The NIAID intends to use various methods to provide Contractors that received a base IDIQ contract a fair opportunity to be considered for subsequent Task Orders. Past Performance factors such as the overall quality of prior work, timeliness, and cost control; potential impact on previous orders; and minimum order requirements may be used.

Each Task Order Request (TOR) issued by the NIAID will include the Statement of Work, Evaluation Factors for award of the Task Order, Reporting Requirements and Deliverables, required components of the offer to be submitted, format for submission, and any other issues pertinent to the Task Order, including information on whether it is anticipated that the Task Order will be awarded with or without discussions. Contractors will not be required to propose on all TORs. Those eligible Contractors that decide not to submit a proposal must notify the NIAID Contracting Officer in writing of their intention not to submit a proposal on or before the closing date and time established in the TOR.

An election not to propose on a given TOR will not negatively affect or prohibit a Contractor from competing on future TORs. However, it may affect the Contractor's eligibility for continuations or extensions of the given Task Order.

EXCEPTIONS TO THE FAIR OPPORTUNITY TO BE CONSIDERED CLAUSE

In accordance with FAR 16.504, the requirement for the Fair Opportunity consideration does not apply to orders under $3,000 or to orders above $3,000 where the NIAID Contracting Officer determines that one of the following statutory exceptions applies:

1) The need for the Task Order is so urgent that providing such opportunity would result in unacceptable delays.

2) Only one Contractor in a given part is capable of providing the services required at the level of quality required because the services are highly specialized.

3) The Task Order should be issued on a sole-source basis in the interest of economy and efficiency as a logical follow-on to a Task Order already issued given that all awardees were given a fair opportunity to be considered on the original order

4) It is necessary to place an order to satisfy a minimum order guarantee under a base IDIQ contract.

TASK ORDER PROCEDURES

In providing services under this contract, the following procedures shall apply to the award of Task Orders.

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.

When the Government elects to fill a requirement that is estimated to exceed $3,000, the Contracting Officer shall provide a TOR to the awardees that received contracts for the particular Part for which responses are being solicited.

A TOR shall, at a minimum, include a Statement of Work, evaluation factors, specific reporting requirements, deliverables and delivery schedule, the relevant importance of technical and cost factors, and any special instructions.

If necessary, the Contracting Officer shall arrange a meeting between contractors and members of the sponsoring office to discuss the proposed Task Order prior to submitting Task Order proposals (technical and business).

Business proposals 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.

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), Contractors shall submit their proposals in response to a TOR, which shall include, but not necessarily limited to the following information:

(i) A statement of the contractor's clear understanding of the task requirements;

(ii) A statement of technical and managerial resources and expertise the contractor can provide to satisfy the requirement;

(iii) An approach to perform the work;

(iv) The labor category necessary, and the number of hours for each labor category necessary, and an explanation of the rationale for determining hours;

(v) Resumes with identification of the actual personnel proposed for the work;

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(vi) A schedule of performance identifying major milestones, deliverables and delivery date, and task completion; and

(vii) An itemization of all costs, both direct and indirect, (i.e. personnel, fringe benefits, equipment, travel, supplies, other direct costs, overhead, etc.) necessary to complete the work.

The Government will evaluate proposals and conduct negotiations as necessary. Task Orders will be awarded to the contractor whose proposal is determined to be the most advantageous to the Government based on the technical and cost factors specified in the TOR. The Government reserves the right to make an award on the most favorable initial proposal 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 sixty (60) 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

Contractors are required to propose hourly rates for each labor classification in their response to each TOR with cost reimbursable contract line items proposed for other elements of cost (i.e. fringe benefits, supplies, travel, equipment, other direct costs, indirect costs, fee, etc.) The subsequent negotiation of TORs issued to successful contractors eligible to submit a proposal under a TOR for which they qualify will focus on the number of hours proposed for each labor category and the estimated costs required for all other elements.

No protest under FAR Subpart 33.1 is authorized in connection with the issuance or proposed issuance of a Task Order under this contract except for a protest on the grounds that the order increases the scope, period, or maximum value of the contract. Task Orders awarded under this contract are not subject to the competition requirements of FAR Part 6.

ARTICLE G.4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD

To initiate and receive prompt payment, the Contractor shall comply with the following procedure:

a. A Task Order Number shall be given to you at the time the order is placed. The Contractor is cautioned not to accept an order unless this number is issued.

b. Invoices shall be submitted monthly for each Task Order issued to the address indicated in ARTICLE G.5.

INVOICE INSTRUCTIONS of this contract. Invoices shall cite the Contract Number and the Task Order Number for each order for which payment is being requested. See ARTICLE G.5. INVOICE INSTRUCTIONS for more information about submission of a proper invoice.

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ARTICLE G.5. 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 as follows:

a. One original 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 to the following approving official:

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

E-Mail: [to be specified at award]

The Contractor shall submit an electronic copy of the payment request to…