NIHAI75N93023R00003 - Signed.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 81692, as Amended

2. Request for Proposal (RFP) Number:

NIHAI75N93023R00003

3. Issue Date:

02/15/2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Pre-Clinical Models of Infectious Diseases

6. ISSUED BY:

Ignacio J. Reyes, Contracting Officer Office of Acquisitions National Institutes of Health National Institute of Allergy and Infectious Diseases 5601 Fishers Lane, Room 3D44 MSC-9821 Rockville, MD 20852-9821

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 3:30 PM EST local time on 05/04/2023. 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 as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Ignacio J. Reyes

PHONE: 301-435-7574

e-MAIL: ignacio.reyes@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

All questions must be submitted to ignacio.reyes@nih.gov by 3:00 PM EST on/before March 15, 2023. Ignacio J. Reyes

Contracting Officer Office of Acquisitions

NIAID

https://www.sam.gov/SAM/

RFP Number : 75N93023R00003

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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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

k. 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. Specific Copyright Provisions Applicable to Software Development and/or Enhancement(s)

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

16. Prohibition on Contractor Involvement with Terrorist Activities

17. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

18. 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. Research Involving Live Vertebrate Animals

6. Dual Use Research of Concern

7. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. Mentor Protege Program, HHSAR 352.219-70

9. HUBZone Small Business Concerns

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

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

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 DATA SHARING PLAN

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

8. TECHNICAL EVALUATION FACTORS

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9. PAST PERFORMANCE FACTOR

10. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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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 services to be acquired include expanding the breadth and depth of diagnostic knowledge in all areas of infectious, immunologic, and allergic diseases and developing flexible domestic and international research capacities and capabilities to respond appropriately and when needed rapidly to mount an effective response to emerging and re-emerging disease threats both domestic and foreign on a local or global scale.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $2,500 (minimum) nor more than a total of$146,300,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period June 03, 2024 through June 02, 2031.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract. Task Orders will be awarded pursuant to the following individual task areas:

Task Area A – Small Animal Models of Infectious Diseases Task Area B – Non-Human Primate Models of Infectious Diseases Task Area C – Animal Replacement and Non-traditional Animal Models of Infectious Diseases Task Area D – Generation and Distribution of Specialized Reagents

a. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

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) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8)

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Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) 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 below Advance Understandings are applicable to this solicitation.

CONFIDENTIALITY

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.

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.

INTELLECTUAL PROPERTY

NIAID has obtained a deviation from FAR clause 52.227-11, Patent Rights-retention by the Contractor (Short Form) (December 2007). Pursuant to a Determination of Exceptional Circumstances (DEC) as required by FAR 27.303, 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 data publication so that appropriate domestic and international invention applications may be filed as appropriate.

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.

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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.

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 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).

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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 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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To ensure success of the Preclinical Models of Infectious Diseases contract program, all contractors are encouraged to be active in reviewing Requests for Task Order Placement (RTOPs) and submitting proposals when there is a reasonable chance for award or submit a "No Bid" response.

Note: If the Contractor is not actively submitting proposals in response to RTOPs in Year 1 and any other years, the Government will reserve the right to terminate the contract. A review of each Contractor's performance will be generated annually.

The off-ramp provision will be in the best interests of the Government to ensure the Government maintains a qualified number of businesses to facilitate adequate competition. The Contracting officer shall conduct annual reviews of each contract and shall make a determination on whether or not to terminate the Contractor. The Contracting Officer will rely heavily on a Contractor's demonstrated past performance under the contract, the Contractor's overall performance, the Contractor’s adherence to contract terms and conditions, and compliance with other key contract provisions such as reporting requirements. The Government reserves the right to off-ramp the Contractor by terminating the contract for convenience of the Government.

RAMP ON OF CONTRACTORS

The Contracting Officer (CO) will review every year the total number of contractors to ensure adequate competition for task orders throughout the ordering period the multiple award IDIQ contract. The total number of contractors may fluctuate due to various reasons, such as general economic conditions, or other reasons. If the CO determines that it is in the best interest of the government to "Ramp On" to the multiple award IDIQ contract new Contractors, the CO has the discretion to announce "Ramp On" period at any time during the effective period of the multiple award IDIQ contract, but no earlier than one year from date of award.

The CO will announce the "Ramp On" period by publishing a notice in SAM.gov.

The "Ramp On" period announcement will provide an estimate of the number of new awards that the CO intends to make. Under the "Ramp On" period the CO will issue a solicitation using substantially the same best value criteria as delineated in Section M of the solicitation. Any offeror meeting the eligibility requirements identified in the new "Ramp On" solicitation may submit a proposal in response to the solicitation. However, the CO has the discretion to award more or fewer contracts than the number anticipated in the solicitation depending upon the quality of the offers received.

Any resulting contracts awarded under this provision will not exceed the remaining ordering period of the existing multiple award IDIQ contract. Any contractor receiving a contract under this "Ramp On" period will be eligible to compete on future task orders with the same rights and obligations of any other Preclinical Models of Infectious Diseases Contractor. Contracts awarded under this "Ramp On" period provision will share in the ceiling of the Preclinical Models of Infectious Diseases contract and the overall ceiling of the basic contract will not be increased.

Dual Use Research of Concern

The offeror shall demonstrate compliance with the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern ( http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf ) or "DURC" policy. The offeror shall provide in its technical proposal each of the following items:

a. Identification of the agents or toxins subject to the DURC policy.

b. A description of the categories of experiments in which the identified agents or toxins produces or aims to produce or can be reasonably anticipated to produce one or more of the effects identified in Section 6 of the DURC policy.

c. For projects involving any of the agents listed in the DURC policy and that involve or are anticipated to involve any of the categories of experiments listed in the DURC policy, an indication of whether or not the project meets the definition of "dual use research of concern" in Section 4C of the policy.

d. For projects meeting the definition of "dual use research of concern," a draft risk mitigation plan.

OFF RAMP OF CONTRACTORS

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e. Certification that the offeror is or will be in compliance with all aspects of the DURC policy prior to use of pertinent agents or toxins.

The Government shall not award a contract to an offeror who fails to certify compliance or whose draft risk mitigation plan is unsatisfactory to the Government. If selected for award, an approved risk mitigation plan shall be incorporated into the contract.

Dual Use Research of Concern is an unscored factor.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-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 October 27, 2022, 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

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html and at: https://www.section508.gov/create/ documents, "Create Accessible Documents."

a. Technical Progress Reports

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.]

Regular Task Order Progress Reports will be required and the frequency will be specified in the Task Order Reporting Requirements. The frequency of these reports may be monthly, quarterly or annually. This report shall include a description of the activities planned for the ensuing reporting period, the activities planned for the ensuing reporting period and an overall assessment of project scheduling and expenditure rate. Scheduling shall be expressed in the form of a Gantt chart.

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

The following reports will be required to be submitted in electronic format:

http://www.hhs.gov/web/508/index.html https://www.section508.gov/create/documents

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This report shall include a description of the activities during the reporting period, the activities planned for the ensuing reporting period, and an overall assessment of project scheduling and expenditure rate. Scheduling shall be expressed in the form of a Gantt chart.

2. Final Study Protocol

The study protocol shall include:

• objective of the study

• description of the animal model

• description of the challenge agent (i.e., provenance, preparation, characterization to confirm identity and ensure concentration/titer and purity)

• description of the test article, including preparation, dose, regimen, and route

• study schedule

• description of the proposed endpoints

• planned statistical analysis

3. Final Task Order Report

a. This report is to include a summation of all work performed and results obtained for the entire task order period of performance.

b. The report shall be in sufficient detail to describe comprehensively the results achieved, including statistical analysis, and should enable a product sponsor to make go/no-go decisions pertaining to the product(s) further evaluation.

c. The Offeror shall submit a draft of the Final Report to the Government for review by the NIAID Contracting Officer’s Representative (COR). The COR will review the draft report and provide comments within 15 days following receipt. The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the table below.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) No hard copies of these reports will be required as follows:

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

1. Monthly Progress Report

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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.

Reporting on Dual Use Research of Concern

a. Progress Report For work involving an agent or toxin identified in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern or "DURC policy" (see https://www.phe.gov/s3/dualuse/ Documents/durc-policy.pdf), the Contractor shall report the following information in the Annual/Semi-Annual/ Quarterly/Monthly Progress report:

i. Identification of agents or toxins that are listed in the DURC policy and used in research funded in this contract, and;

ii. Proposed modifications, if any, to the risk mitigation plan.

b. Special Notifications The Contractor shall report to the Contracting Officer's Representative, within 30 calendar days of:

i. Any change in the status of the DURC project funded under this contract (including whether the research is determined by the Contractor's institutional review entity to no longer meet the definition of DURC);

ii. Details of any changes to risk mitigation plans (such changes need to be pre-approved by the Contracting Officer Representative), or;

iii. Instances of noncompliance with the DURC policy, as well as mitigation measures undertaken by the Contractor to prevent recurrences of similar noncompliance.

Reporting 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 MonthlyProgress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," 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 IBC or equivalent body or institutional biosafety official.

2. 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:

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

b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b https://www.selectagents.gov/ regulations/index.htm) or listed on the U.S. National Select Agents Registry restricted experiments website ( https://www.selectagents.gov/compliance/guidance/restricted/index.htm);

c. The name 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 or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

https://www.selectagents.gov/regulations/index.htm https://www.selectagents.gov/regulations/index.htm https://www.selectagents.gov/compliance/guidance/restricted/index.htm https://www.phe.gov/s3/dualuse/ https://www.phe.gov/s3/dualuse/

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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 Monthly 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 Monthly Progress Report.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94. See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/ default/files/web/508/contracting/technology/section_508_annual_report.doc.

3. Multiple Principal Investigators Leadership Plan The Contractor must submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website:

https://erds.niaid.nih.gov/. All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section-508/index.html and at: https:// www.section508.gov/create/documents, "Create Accessible Documents."

https://www.ecfr.gov/current/title-45/part-94 https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://erds.niaid.nih.gov/ https://www.hhs.gov/web/section-508/index.html

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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. Thereafter, reports shall be due on or before the 15th Calendar day following the reporting period. 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:

Ignacio Reyes - Contracting Officer National Institutes of Health 5601 Fishers Lane, Room 3D44, MSC 9821 Rockville, MD 20852-9821 Office of Acquisition Ignacio.reyes@nih.gov

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 required 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.

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. All reports required herein shall be submitted in electronic format.

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, To be specified prior to award is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Rockville, MD 20852-9821 http://www.iedison.gov

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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).

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 (NOTE- Specific deliverables will be identified in future Task Order/Area Solicitations):

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 Recipients Delivery Schedule

(1) Monthly Progress Report Submitted via eRDS Each report is due on or before the 15th of each month following each reporting period.

(2) Final Study Protocol Submitted via eRDS Each report is due on or before the 15th of each month following each reporting period.

(3) Final Report Submitted via eRDS Report is due on the last day of the reporting period.

(4) Summary of Salient Results

Submitted via eRDS Due no later than the last day of the reporting period.

(5) Reporting of Select Agents and Toxins

Submitted via eRDS Each report is due on or before the 15th of each month following each reporting period.

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

All reports required herein shall be submitted in electronic format. All electronic contract deliverables listed in the delivery schedule above shall be submitted via eRDS (NIAID’s electronic Report Deliverable Submission), available at the following website: http://erds.niaid.nih.gov/.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under “Making Files Accessible.”

http://erds.niaid.nih.gov/

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ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 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: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

"To be specified prior to award".

The COR 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

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; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

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

https://www.acquisition.gov/?q=browsefar

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Name Title

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained in this contract shall be incorporated in the TORFP and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit…