75N94026R00005_BTF_Solicitation_4_13_26.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: FAR 15.204-2(a)(2)

2. Request for Proposal (RFP) Number:

75N94026R00005

3. Issue Date:

April 13, 2026

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : BIOLOGICAL TESTING FACILITY

6. ISSUED BY:

Office of Acquisitions and Logistics Management (OALM), NIH R&D Professional Services, Division B on behalf of Eunice Kennedy Shriver Institute of Child Health & Human Development National Institutes of Health 6710B Rockledge Drive First Floor MSC 7000 Bethesda, Maryland 20892-7000

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal"

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 EST local time on May 28, 2026. 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 subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," 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 http://www.sam.gov

11. Primary Contact: Sean Dunn e-MAIL: sean.dunn@nih.gov

Please see additional proposal instructions attached to this RFP.

Additionally, see electronic size limitation in Attachment 1 of this RFP entitled, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.

Questions must be submitted in writing via email by May 1, 2026.

Secondary Contact Gannon White, Contracting Officer Email: gannon.white@nih.gov

Proposals due by 4:00pm (Eastern) Thursday May 28th, 2026 http://www.sam.gov Gannon White Rectangle

Gannon White Rectangle

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. PROVISIONS APPLICABLE TO DIRECT COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications/Work Statement

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging, Marking, and Shipping

SECTION E - Inspection and Acceptance

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. RFO 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. TASK ORDER PROCEDURE

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. RFO 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023) .. 18

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-

FUNDED RESEARCH

4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

6. ANIMAL WELFARE

7. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

8. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

9. GUN CONTROL

10. SUBCONTRACTING PROVISIONS

11. SECURITY REQUIREMENTS FOR GOVERNMENT-OWNED CONTRACTOR-OPERATED AND

CONTRACTOR-OWNED CONTRACTOR-OPERATED RESOURCES, HHSAR 352.239-76 (Feb 2024)

(DEVIATION)

12. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

13. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

14. PUBLICATION AND PUBLICITY

15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

16. SHARING RESEARCH DATA

17. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

18. HHSAR 352.270-5 b Care of Live Vertebrate Animals. (DEC 2015)

SECTION I - Contract Clauses

1. GENERAL CLAUSES

2. AUTHORIZED SUBSTITUTION OF CLAUSES

3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

4. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

SECTION L - Instructions, Conditions, and Notices to Bidders

1. HHSAR 352.215-70 Late Proposals and Revisions. (DEC 2015)

2. HHSAR 352.219-70 Mentor-Protege Program. (DEC 2015)

3. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

4. HHSAR 352.270-5 a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. (DEC 2015)

5. RFO 52.204-7 SYSTEM FOR AWARD MANAGEMENT-REGISTRATION. (NOV 2024) (Deviation NOV 2025)

6. RFO 52.209-12 Certification Regarding Tax Matters. (OCT 2025)

7. RFO 52.215-1 INSTRUCTIONS TO OFFERORS-COMPETITIVE ACQUISITION. (NOV 2021) (Deviation

NOV 2025)

8. RFO 52.215-1 INSTRUCTIONS TO OFFERORS-COMPETITIVE ACQUISITION. (NOV 2021) (Deviation NOV 2025) - ALTERNATE I (OCT 1997) (Deviation NOV 2025)

9. RFO 52.215-20 REQUIREMENTS FOR CERTIFIED COST OR PRICING DATA AND DATA OTHER THAN CERTIFIED COST OR PRICING DATA. (NOV 2021) (Deviation NOV 2025)

10. RFO 52.215-20 REQUIREMENTS FOR CERTIFIED COST OR PRICING DATA AND DATA OTHER THAN CERTIFIED COST OR PRICING DATA. (NOV 2021) (Deviation NOV 2025) - ALTERNATE I (OCT 2010) (Deviation NOV 2025)

11. RFO 52.232-38 Submission of Electronic Funds Transfer Information with Offer. (JUL 2013)

12. RFO 52.233-2 SERVICE OF PROTEST. (SEP 2006) (Deviation NOV 2025)

SECTION M - Evaluation Factors for Award

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Biological Testing Facility (BTF) fulfills a unique role in bridging the discovery and optimization of potential antifertility agents to the development and approval of the drug. To this end, the BTF has an important role in enriching and providing the pre-clinical studies necessary to make progress toward the clinical development of high quality, safe and effective male and female fertility management and reproductive health products.

The objective of this contract is for the Biological Testing Facility (BTF) to serve with the capability to carry out the in vitro enzymatic and cell based assays, in vivo studies, anti-fertility assessments, endocrine activity, toxicity, formulation, stability, Absorption Distribution Metabolism Excretion (ADME) profiling and Drug Metabolism Pharmacokinetics (DMPK) profiling of new chemical compounds, delivery systems, and devices and all activities related to preclinical development of products that can be tested in clinical trials for fertility management, reproductive health, and therapeutics.

ARTICLE B.2. PRICES/COSTS

a. This is an 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 $100,000 (minimum) nor more than a total of $49,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE TBD will cover the contract period 09/30/2026 through 09/29/2033.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

d. Ordering procedures are described in the TASK ORDER PROCEDURE Article in Section G of this contract.

e. 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) 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)

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.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-SPECIFICATION-STATEMENT OF WORK

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 March 12, 2026, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

Note: Please be advised that the contractor shall perform work under this contract only as direct through Task Orders (TOs) issued by the Contracting Officer (CO).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format, via the NICHD Contracts Portal. All electronic contract deliverables shall be submitted via the NICHD Contracts Portal . Access to the NICHD Contracts Portal will be provided to the successful offeror following contract award

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." The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal in order to initiate access to the Portal.

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order. Deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued.

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note:

Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

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

http://www.hhs.gov/web/508/index.html

[ ] Monthly

[] Quarterly

[X] Semi-Annually

[] Annually

[ ] Annually (with a requirement for a Draft Annual Report)

[X] Final - Upon final completion of the contract

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

2. Summary of Salient Results

The Contractor shall prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. 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 CFR 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.)

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-13, Patent Rights-Ownership by the Government 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 https://www.ecfr.gov/current/title-45/part-94 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 Contracting Officer (CO) at the following email address:

Gannon White

Gannon.white@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.

mailto:Gannon.white@nih.gov http://www.iedison.gov/

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.

Note: Packaging and marking instructions will be specified if necessary in individual task order(s).

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 Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Eunice Kennedy Shriver National Institute for Child Health & Human Development

(NICHD)

6701 Rockledge Drive Bethesda, Maryland 20892-7000

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer (CO) 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 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is anticipated to be from 09/30/2026 through 09/29/2033.

ARTICLE F.2. RFO (REVOLUTIONARY FAR OVERHAUL) 52.252-2 CLAUSES

INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/browse/index/far.

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.

(End of clause)

ARTICLE F.3 DELIVERIES

Item Type of Deliverable Electronic Submission Reports Due

1. Semi-Annual Progress Report* NICHD Contracts Portal 1. April 30th (approx.)

2. October 30th (approx.)

2. Final Report NICHD Contracts Portal First draft is due three months prior to the completion date of the contract. The final report is due 10 days before the completion date of the contract.

*Semi-Annual Progress Reports are due within 30-days following the mid-point of a performance period (approximately April 30th), and within 30-days following the completion of a performance period

(approximately October 30th).

The due dates provided are assuming a contract fully executed by September 30, 2026.

Additional Report Instructions:

https://www.acquisition.gov/browse/index/far

• The Semi-Annual Report due on April 30th shall document of all activities carried out by the Contractor as requested by the COR. Report should include problems encountered and how they were resolved during the last three months and the activities planned for the next reporting period.

• The Semi-Annual Report due on October 30th shall provide summary of the work performed and results obtained for the entire year of performance. The report shall be in sufficient detail to describe comprehensively the results achieved including a detailed description of any studies performed as a result of the Statement of Work.

• The Final Report shall provide A summary of the work performed and results obtained for the entire contract period of performance. The report shall be in sufficient detail to describe comprehensively the results achieved including a detailed description of any studies performed as a result of the Statement of Work.

The Contractor shall submit, with the final report, an executive summary of salient results achieved during the performance of the entire contract period.

The first draft of the Final Report is due three months prior to the completion date of the contract. The final draft of the Final Report is due 10 days before the completion date of the contract.

*** It should be noted that additional deliverables may be included as needed within the specific task order(s) subsequently issued under this IDIQ contract. These additional deliverables include, but are not limited to: monthly progress reports, quarterly progress reports, subcontractor performance assessment, etc. Due dates of these reports will be specified in their respective task order. ***

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 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.3. 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 30 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:

Name Title

TBD PRIOR TO AWARD TBD PRIOR TO AWARD

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 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.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be [significantly more important than cost or price/approximately equal to cost or price/significantly less important than cost or price] However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

ARTICLE G.4. INVOICE SUBMISSION – COST REIMBURSEMENT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type Contracts 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. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov, as directed below.

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

i. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is OALM Professional Services Division B, Branch 3.

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

iii. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the https://www.ipp.gov/ contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

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

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

vi. The Contract Title is:

TITLE OF INDIVIDUAL TASK ORDER

vii. Contract Line Items as follows:

Line Item # Line Item Description

Line item(s) will be specified in individual Task Order(s)

b. Inquiries regarding payment of invoices shall be directed to the designated billing office at

(301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

'I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract.'

ARTICLE G.5. INDIRECT COST RATES

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

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

National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Indirect Cost Branch's information package documents.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually.

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

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

a. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://www.cpars.gov

ARTICLE G.7. RFO 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023)

(a)(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://www.cpars.gov/ after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

SECTION H - Special Contract Requirements

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources.

This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103, "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102, "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at https://grants.nih.gov/policy/reproducibility/index.htm, including FAQs and a General Policy Overview.

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS

RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) electronic versions of all Author Accepted Manuscripts arising from this contract in whole or in part, upon acceptance for publication. NIH defines the Author Accepted Manuscripts as the author's final version that has been accepted for journal publication and includes all revisions resulting from the peer review process, including all associated tables, graphics, and supplemental material. NIH-funded investigators shall notify their Contracting Officers and Contracting Officer Representatives upon the acceptance of an Author Accepted Manuscript resulting from the contract, even if co-authored with those not using contract funds. Through execution of this contract, contractor, and through implementation of this provision by contractor to each of contractor's investigators and subcontractor, and through implementation of this provision to each of subcontractor's investigators, conducting work under this contract or a subcontract, respectively, hereby grants to NIH a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use for federal purposes and to authorize others to do so, all Author Accepted Manuscripts that result from this contract, which includes making Author Accepted Manuscripts publicly available in PubMed Central upon the Official Date of Publication, in accordance with the 2024 NIH Public Access Policy. Upon receipt of a PMCID, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://grants.nih.gov/policy/reproducibility/index.htm investigators should report the PMCID to their Contracting Officers and Contracting Officer Representatives to demonstrate compliance with this term of the contract. The PMC archive will permanently preserve and retain these manuscripts for use by the public, health care providers, educators, scientists, and NIH. NIH Policy directs electronic submissions to the NIH/NLM/PMC:

https://www.ncbi.nlm.nih.gov/pmc/.

Additional information is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25- 047.html and https://grants.nih.gov/policy-and-compliance/policy-topics/public-access

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.6. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: https://olaw.nih.gov/policies-laws/phs-policy.htm.

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated TBD, which is incorporated by reference.

ARTICLE H.7. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, "Protection of NIH Personnel Who Work with Nonhuman Primates," located at the following URL:

https://policymanual.nih.gov/3044-2.

ARTICLE H.8. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

https://www.ncbi.nlm.nih.gov/pmc/ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-047.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-047.html https://grants.nih.gov/policy-and-compliance/policy-topics/public-access https://olaw.nih.gov/policies-laws/phs-policy.htm https://policymanual.nih.gov/3044-2

ARTICLE H.9. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.10. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled " Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages- Subcontracting Plan."

b. Subcontracting Reports

1. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov. The offeror shall follow the instructions outlined in the SBCX Industry Guide at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

2. The official point of receipt for determining timely submission of an offeror's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

3. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late in accordance with subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offeror-Competition Acquisition. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday - Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and https://osdbu.hhs.gov/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j mailto:client.support@apexlogic.com a representative will respond within the presented client support hours of operation for assistance.

5. Individual Subcontract Reports (ISR)

The Contractor must submit the following Subcontracting reports electronically via https://www.sam.gov.

Regardless of the effective date of this contract, the Report shall be due approximately on the following dates for the entire life of this contract:

• April 30th

• October 30th

• Expiration Date of Contract

• Summary Subcontract Report (SSR) o Regardless of the effective date of this contract, the Summary Subcontract Report must be submitted annually on the following date for the entire life of this contract:

o October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer/Contract Specialist must be included as a contact for notification purposes at the following e-mail address(es):

Gannon.White@nih.gov Sean.Dunn@nih.gov Gannon White Sean Dunn Contracting Officer Contract Specialist

ARTICLE H.11. SECURITY REQUIREMENTS FOR GOVERNMENT-OWNED CONTRACTOR-

OPERATED AND CONTRACTOR-OWNED CONTRACTOR-OPERATED RESOURCES, HHSAR

352.239-76 (Feb 2024) (DEVIATION)

(a) Federal policies. The Contractor shall comply with applicable federal laws, regulations, and HHS policies that include, but are not limited to-

(1) HHS Policy for Information Security and Privacy Protection (IS2P);

(2) Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101);

https://www.sam.gov/ mailto:Gannon.White@nih.gov mailto:Sean.Dunn@nih.gov

(3) National Institute of Standards and Technology (NIST) Special Publication (SP) 800- 53, latest revision, Security and Privacy Controls for Information Systems and Organizations;

(4) Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and

(5) Any other applicable federal laws, regulations, NIST guidance, and local HHS policies.

(b) Assessment and Authorization (A&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data.

If the system under this contract does not have a valid ATO, the Contractor shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor shall conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800-53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800-53A (latest revision). HHS acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

(1) A&A package deliverables. The Contractor (and/or any subcontractor) shall provide an A&A package within 30 days of contract award to the CO and/or COR. The following A&A deliverables are required to complete the A&A package-

(i) [Contracting Officer insert specific deliverables, as applicable, in addition to the HHS baseline listed below]:

(ii) A System Security Plan (SSP) is due within 30 days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800- 53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system (see HHSAR 302.101, Definitions) as well as describe all applicable security controls in place or planned for meeting those requirements.

It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall review and update the SSP at least annually thereafter and if requested, provide a copy of the updated SSP to the COR.

(iii) A Security Assessment Plan/Report (SAP/SAR) is due 30 days after contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS policies. The assessor will document the assessment results in the SAR. Thereafter, the Contractor, in coordination with the COR shall conduct, or as directed, in the assessment of the security controls and update the SAR at least annually. A copy of the updated SAR shall be provided to the COR, if requested.

(iv) All systems shall have a completed privacy threshold analysis (PTA). If the PTA results determines the system contains personally identifiable information, a privacy impact assessment, approved by the HHS SAOP, is required.

(v) System Privacy Plan and Privacy Control Assessment. As required in OMB Circular A-130, a System Privacy Plan and Privacy Control Assessment shall be included in A&A. The plan and assessment may be included in the Security System Plan, or a separate report in the A&A, as determined by the COR.

(vi) An Independent Assessment is due 90 days after the contract award. The Contractor shall have an independent third-party validate the security and privacy controls in place for the system(s) commensurate with the risk levels per NIST SP 800-53B. The independent third party shall review and analyze the security authorization package and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all "high" deficiencies before submitting the package to the Government for acceptance and document all remaining deficiencies in a system Plan of Actions and Milestones (POA&M).

(vii) The POA&M is due as follows-

(A) 30 days after contract award;

(B) Critical-risk weaknesses must be mitigated within 30 days from the date the weaknesses are formally identified and documented;

(C) High-risk weaknesses must be mitigated within 30 days from the date the weaknesses are formally identified and documented;

(D) Medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented; and

(E) Low weaknesses must be mitigated within [Contracting Officer insert specific timeline], from the date the weaknesses are formally identified and documented.

(2) HHS will determine the risk rating of all vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, flaws and security defect in a system (that require to create a patch for remediation), and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document consistent with the HHS Standard for Plan of Action and Milestones policies. Depending on the severity of the risks, HHS may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, continue to remediate weaknesses throughout the contract. The POA&M document shall be updated at least quarterly.

(3) A Contingency Plan and Contingency Plan Test are due 60 days after contract award.

The Contingency Plan shall be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS policies. Upon final acceptance by the System Owner, the Contractor, in coordination with the COR and System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned, and any remaining action items to be addressed. The Contractor shall update and test the Contingency Plan at least annually.

(4) An E-Authentication Questionnaire is required. The Contractor shall collaborate with at the COR's direction to ensure that the E-Authentication Guidance requirements are implemented in…