Sol_75N94025R00008.pdf

SECTION

15A. NAME AND

ADDRESS

OF OFFEROR

SOLICITATION, OFFER, AND AWARD 1. This Contract is a Rated Order under the Defense Priorities and Allocations System (DPAS) - Code of Federal Regulations - at 15 CFR 700.

RATING PAGE

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

CODE7. ISSUED BY 8. ADDRESS OFFER TO (If other than item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in until local time

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision Number 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR

INFORMATION

CALL:

A. NAME B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

C. EMAIL ADDRESS

11. TABLE OF CONTENTS

(X) DESCRIPTION PAGE(S) (X) SECTION PAGE(S)DESCRIPTION

A B

C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause Number 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

DATEAMENDMENT NUMBERAMENDMENT NUMBER DATE

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

AREA CODE NUMBER EXTENSION

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION UNDER THE

UNITED STATES CODE AT:

10 U.S.C. 3204(a) ( )41 U.S.C. 3304(a) (

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 12/2022)

Prescribed by GSA - FAR (48 CFR) 53.214 (c)

SEALED BID (IFB) INVITATION FOR BID

NEGOTIATED (RFP) REQUEST FOR

PROPOSAL

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

15B. TELEPHONE NUMBER

CODE

OF PAGES

75N94025R00008 jason.williams2@nih.gov

JASON S. WILLIAMS

National Institutes of Health National Institute of Child Health Bethesda, MD 20892-7511

NICHD

1630 ED

JASON S WILLIAMS

06/10/2026

+13 014-4338 77

04/23/2026

1 138

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: 42 U.S.C. 285n

2. Request for Proposal (RFP) Number:

75N94025R00008

3. Issue Date:

April 23,

4. Set Aside: 100% Small Business Set Aside [ ] No [X] Yes See Part IV Section L

5. Title : Clinical Research Organization for the National Institute on Alcohol Abuse and Alcoholism Medications Development Clinical Trials Network

6. ISSUED BY:

National Institutes of Health (on behalf of

NIAAA), OD, OALM

R&D and Prof Services Contracts, Div B

6701 Rockledge Drive Bethesda, MD 20817

7. SUBMIT OFFERS TO:

See Part III, Section J, ATTACHMENT 1, “Packaging and Delivery of Proposals”, of this Solicitation

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received as specified in Section J, ATTACHMENT 1, “Packaging and Delivery of Proposals”, until 4:30 PM Eastern Daylight Time on June 10, 2026. Offers will be valid for 180 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 Section J, ATTACHMENT 1, "Packaging and Delivery of Proposals”. Proposal must be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website, https://www.ecps.nih.gov

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS

DESIGNEE AT THE PLACE AND TIME SPECIFIED IN THIS SOLICITATION , THEN IT

WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of RFO Provision 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED

IN SECTION L 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 CONTACT: Jason Williams, Contracting Officer e-MAIL: jason.williams2@nih.gov Phone: 301-443-3877

COLLECT CALLS WILL NOT BE ACCEPTED.

Questions must be submitted in writing via e-mail to jason.williams2@nih.gov and lisa.schaupp@nih.gov by May 13, 2026.

Secondary Contact:

Lisa Schaupp, Section Chief, NIH OD OALM, R&D and Prof Svcs Contracts, Div B lisa.schaupp@nih.gov https://www.ecps.nih.gov/ https://www.sam.gov/SAM/ mailto:jason.williams2@nih.gov mailto:jason.williams2@nih.gov mailto:lisa.schaupp@nih.gov mailto:lisa.schaupp@nih.gov

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. ESTIMATED COST AND FIXED FEE

4. ESTIMATED COST - OPTION

5. PROVISIONS APPLICABLE TO DIRECT COSTS

6. 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

2. RFO 52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

4. 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. CONTRACT FINANCIAL REPORT

5. INDIRECT COST RATES

6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

7. GOVERNMENT PROPERTY

8. RFO 352.237-75 Key Personnel

9. RFO 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023)...20

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. CERTIFICATE OF CONFIDENTIALITY

3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

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

FUNDED RESEARCH

5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

7. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

8. GUN CONTROL

9. OPTION PROVISION

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

11. INFORMATION SYSTEM HOSTING, OPERATIONS, MAINTENANCE, OR USE, HHSAR 352.239-74

(FEB 2024) (DEVIATION)

12. SUPPLY CHAIN RISK ASSESSMENT

13. SUPPLY CHAIN RISK ASSESSMENT DURING CONTRACT PERFORMANCE

14. CONFIDENTIALITY OF INFORMATION

15. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

16. PUBLICATION AND PUBLICITY

17. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

18. SHARING RESEARCH DATA

19. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

20. HHSAR 352.224-70 Privacy Act. (DEC 2015)

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

SECTION I - Contract Clauses

1. GENERAL CLAUSES

2. AUTHORIZED SUBSTITUTION OF CLAUSES

3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

4. SMALL BUSINESS ADMINISTRATION - 8(a) PROGRAM CLAUSES

5. 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 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

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

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

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

5. 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)

6. RFO 52.215-22 LIMITATIONS ON PASS-THROUGH CHARGES-IDENTIFICATION OF SUBCONTRACT EFFORT. (OCT 2009) (Deviation NOV 2025)

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

8. RFO 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

SECTION M - Evaluation Factors for Award

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall, though individual Task Orders issued under this indefinite delivery/indefinite quantity contract, provide Contract Research Organization (CRO) support services to assist the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in study development and study and data management of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder performed by NIAAA clinical site contractors under the NIAAA Medications Development Clinical Trials Network. Services may include, but are not limited to, study development support inclusive of draft protocol development and regulatory affairs materials preparation for submittal to the Food and Drug Administration (FDA), Good Clinical Practice (GCP) monitoring services, preparation of study documents, electronic clinical data capture of clinical data from all participating clinical sites and data monitoring, acquisition and facilitation of packaging/shipping/coordination of study medication, regulatory support, statistical and data analysis and final clinical study report formatting and preparation.

2. PRICES/COSTS

a. This is a single-award Indefinite Delivery / Indefinite Quantity (IDIQ) contract as contemplated by RFO 16.504. The Contractor shall be reimbursed by the Government in an amount not less than $5,000 (guaranteed minimum) nor more than $18,000,000 (maximum [ceiling] ordering amount) over the ordering period of this base indefinite delivery / indefinite quantity contract for successful performance. The guaranteed minimum ordering amount is intended to be fulfilled with the award of the "Core and Study Development Support" Task Order made part of this RFP, concurrent with the award of the base IDIQ contract.

b. The IDIQ ordering period is seven-years total from the date of IDIQ award (with an option to extend the ordering period by six-months as long as the maximum [ceiling] ordering amount is not reached). The anticipated ordering period is 11/15/2026 -- 11/14/2033.

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

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

3. ESTIMATED COST AND FIXED FEE

TO BE INCLUDED IN TASK ORDER AWARDS ISSUED UNDER THIS INDEFINITE DELIVERY/INDEFINITE

QUANTITY CONTRACT

a. The estimated cost of this task order is $ [TBD upon award of each task order] .

b. The fixed fee for this task order is $ [TBD upon award of each task order] . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the task order, represented by the sum of the estimated cost plus the fixed fee, is $ [TBD upon award of each task order] .

4. ESTIMATED COST - OPTION

TO BE INCLUDED IN TASK ORDERS THAT CONTAIN OPTIONS (such as the "Core and Study Development Support" Task Order to be awarded concurrent with the base IDIQ contract)

a. The estimated cost of the Base Period of this task order is $ [TBD upon award of task order] .

b. The fixed fee for the Base Period of this task order is $ [TBD upon award of task order]. The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the task order, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $[TBD upon award of task order].

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated task order amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($)

Fixed Fee

Estimated Cost Plus Fixed Fee

Base period TBD TBD TBD Option Period(s): TBD TBD TBD Total [Base Period and Option(s)] TBD TBD TBD

5. 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.

6. 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.

If this award is a parent indefinite delivery award or a Blanket Purchase Agreement Set-Up, then HHSAR 352.232-71 applies to all task/delivery orders or Blanket Purchase Agreement calls issued under this award.

SECTION C - Description/Specifications/Work Statement

1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements contained in the Base IDIQ Contract Statement of Work, dated 01/16/2026, 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 directed in Task Order(s) issued by the Contracting Officer.

b. The applicable Privacy Act System of Records (SORN 09-25-0200) shall be used in any design, development, or operational work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative. Though collected electronic study data from clinical sites will be de-identified, the CRO Contractor is anticipated to have view access of hard copy informed consent forms, which contain the names of study participants (PII).

2. REPORTING REQUIREMENTS

a. Task Order Technical Progress Reports and other Deliverables:

See RFP ATTACHMENT "List of Possible Deliverables for Task Orders Issued Under the Base IDIQ Contract", dated 02/20/2026, 9 pages.

Unless indicated otherwise, all reports shall be submitted electronically.

These reports 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: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents, "Create Accessible Documents."

b. Summary of Salient Results

In addition to a Final Clinical Study Report deliverable, the Contractor will be required to prepare and submit a task order summary (not to exceed 200 words) of salient results achieved during the performance of the task order. This report will be required on or before the expiration date of the task order.

c. Other Reports/Deliverables and Additional Information

i. 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.)

ii. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

iii. 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) as specified in task orders issued under the base IDIQ contract. 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/sectio n_508_annual_report.doc.

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.

For each applicable task order, the annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the issued task order.

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 electronically to the Contracting Officer.

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

A. 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, Marking and Shipping instructions will be specified, as necessary, in individual Task Orders.

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:

The National Institute on Alcohol Abuse and Alcoholism Medications Development Branch 6700 Rockledge Dr Bethesda, MD 20817

Inspect by Individual

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)

RFO 52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

The Government has the right to inspect and evaluate the work performed or being performed under the contract, and the premises where the work is being performed, at all reasonable times and in a manner that will not unduly delay the work. If the Government performs inspection or evaluation on the premises of the Contractor or a subcontractor, the Contractor shall furnish and shall require subcontractors to furnish all reasonable facilities and assistance for the safe and convenient performance of these duties.

(End of clause)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The ordering period for this IDIQ contract shall be from TBD -- seven-year ordering period for new task orders from the date of IDIQ award (currently anticipated to be November 15, 2026 -- November 14, 2033). The ordering period may be extended up to six-months in accordance with the Option to Extend Services clause as long as the maximum [ceiling] ordering amount has not been reached.

2. DELIVERIES

a. Satisfactory performance of this 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 all deliverables specified in the Delivery Schedule of each issued Task Order which are described in SECTION C of this contract.

b. Deliveries required by the Contractor shall be made F.o.b. destination as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within consignees Premises (April 1984) and any specifications stated in SECTION D, PACKAGING AND MARKING AND SHIPPING, of this contract.

c. Unless otherwise specified, deliveries shall be made to the Delivery Point specified in the applicable Task Order Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

3. RFO 52.242-15 Stop-Work Order. (AUG 1989)

4. RFO 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/these address(es): https://acquisition.gov for FAR/RFO clauses and https://acquisition.gov/hhsar for HHSAR clauses.

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

To be specified prior to final contract execution.

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.

2. 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.

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.

Upon completion of evaluations and any necessary technical and/or cost negotiations, the Contracting Officer will issue a task order to the Contractor.

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NICHD Office of Acquisitions, ARB.

b. 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.

c. 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 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.

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

e. 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.

f. Number and Title of Task Order: [to be identified upon the award of each task order] -- EACH TASK ORDER WILL HAVE ITS OWN SEPARATE

ACCOUNTING/BILLING

g. Task Order Line Items as identified in Task Order. [Note: Most task orders will only have a single line item to cover the entire task order period of performance until completion. The "Core and Study Development Support" task order will, however, contain multiple line items, one for each "fixed" 12-month performance period].

Task Order Line Item # Task Order Line Item Description

TBD TBD

2. Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6452 .

3. 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 (FEB 2026)(RFO DEVIATION) 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.'

4. CONTRACT FINANCIAL REPORT

a. Financial reports on the attached Form NIH 2706, Financial Report of Individual Project/Contract, shall be submitted by the Contractor in accordance with the Instructions for Completing Form NIH 2706, which accompany the form, in an original and two copies, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are listed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

b. Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled " PREPARATION INSTRUCTIONS ," all columns A through J, shall be completed for each report submitted.

c. The first financial report shall cover the period consisting of the first full calendar month following the date of the contract, in addition to any fractional part of the initial month.

Thereafter, reports will be on a Monthly basis.

d. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

e. The following is a listing of expenditure categories to be reported:

Expenditure Category A Percentage of Effort/Hours

(1) Direct Labor

(a) Principal Investigator

(b) Co-Principal Investigator

(c) Key Personnel

(i)

(ii)

(iii)

(2) Other Professional Personnel

(3) Personnel - Other

(4) Fringe Benefits

(5) Accountable Personal Property

(6) Materials/Supplies

(7) Patient Care Costs

(8) Travel

(9) Consultant Costs

(10) Premium Pay

(11) Computer Costs

(12) Subcontract Costs

(13) Other Direct Costs

(14) Indirect Costs

(15) G&A Expense

(16) Total Cost

(17) Fee

(18) Total Cost Plus Fixed Fee

f. The Government may unilaterally revise the NIH 2706 to reflect the allotment of additional funds.

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 Branch's information package documents.

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 as follows on to be specified in each applicable task order.

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.

End of clause.

7. GOVERNMENT PROPERTY

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

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%2 0of%20Government%20Property-Appendix%20Q.pdf

8. Key Personnel

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.

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

Name Title TO BE SPECIFIED PRIOR TO AWARD Project Director

9. 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, 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.

SECTION H - Special Contract Requirements

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.

2. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

• Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten (10) calendar days prior to disclosure.

• Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

• Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

• Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any company/institution/individual not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate understand that they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. The Contractor shall ensure that Subcontractors who receive funds to carry out part of the Federal award understand they are also subject to subsection 301(d) of the Public Health Service Act and the NIH Policy for Issuing CoC.

3. 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.

4. 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, 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

5. 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.

6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

7. 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.

8. GUN CONTROL

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

9. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clauses set forth in SECTION I., the contract and any associated task orders will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract and associated task orders. Pursuant to FAR Clause 52.217-8, Option to Extend Services and FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I.