Sol_75N95024R00086.pdf

75N95024R00086

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

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

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 161

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

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

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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 price set opposite each item, delivered at the

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)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

08/19/2024 X

NIDA-EXEC

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

1700 ED 10/03/2024

EVAN C FEELY +13 01

evan.feely@nih.gov

018-2753

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X

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PAGE(S)

RIEKA N. PLUGGE

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 161

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N95024R00086

(A) (B) (C) (D) (E) (F)

Phase I Clinical Trials for Development of Small

Molecule and Biologics Therapeutics

Please refer to Attachment 1: Cover Letter

Period of Performance: 04/01/2025 to 03/31/2035

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SECTION A - Solicitation/Contract Form

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. PROVISIONS APPLICABLE TO DIRECT COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

SECTION D - Packaging and Marking

SECTION E - Inspection and Acceptance

FAR Clause 52.246-9 Inspection of Research and Development (Short Form) (APR 1984)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

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. INVOICE SUBMISSION (FIXED-PRICE)

5. INDIRECT COST RATES

6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

7. GOVERNMENT PROPERTY

8. KEY PERSONNEL, HHSAR 352.237-75 (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

4. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN NIH-FUNDED CLINICAL

TRIALS

5. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION

6. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

7. CERTIFICATE OF CONFIDENTIALITY

8. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

9. INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN AS PARTICIPANTS IN RESEARCH INVOLVING

HUMAN SUBJECTS

10. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

11. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

12. RESEARCH AND DEVELOPMENT DATA IN ELECTRONIC RESEARCH ADMINISTRATION (eRA)

SYSTEM

13. PUBLIC HEALTH SURVEILLANCE EXCLUSION

14. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

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

FUNDED RESEARCH

16. ACKNOWLEDGEMENT OF FEDERAL FUNDING

17. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED

SUBSTANCES

18. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

19. MULTIPLE PRINCIPAL INVESTIGATORS

20. OMB CLEARANCE

21. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

22. GUN CONTROL

23. OPTION PROVISION

24. SUBCONTRACTING PROVISIONS

25. CONFIDENTIALITY OF INFORMATION

26. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

27. PUBLICATION AND PUBLICITY

28. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

29. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

30. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

31. SHARING RESEARCH DATA

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

33. CONSTITUTION DAY

34. HHSAR 352.239-74 Electronic and Information Technology Accessibility. (DEC 2015)

35. HHSAR 352.270-4 a Notice to Offerors, Protection of Human Subjects. (DEC 2015)

36. HHSAR 352.270-4 b Protection of Human Subjects. (DEC 2015)

37. HHSAR 352.270-12 Needle Exchange. (DEC 2015)

38. HHSAR 352.270-13 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research. (DEC 2015)

SECTION I - Contract Clauses

1. GENERAL CLAUSES

2. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

3. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

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

SECTION L - Instructions, Conditions, and Notices to Offerors

m. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021) - Alternate I (OCT 1997)

n. FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than Cost or Pricing Data. (NOV 2021) - Alternate IV (OCT 2010)

o. FAR 52.233-2 Service of Protest. (SEP 2006)

p. Solicitation Provisions Incorporated by Reference. (FEB 1998)

SECTION M - Evaluation Factors for Award

SECTION A - Solicitation/Contract Form

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS

IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS

SOLICITATION. ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

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

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute on Neurological Disorders and Stroke (NINDS) has the need for a full service, turn-key phase I clinical trials operations and facility for the development of novel therapeutics. This full-service facility would support a full range of services from protocol development through submission of a final clinical study report. The Phase I clinical trial investigational agents to be assessed may include small molecules and large biologic molecules (i.e., peptides, oligonucleotides, proteins, or other biologics). The results of these Phase I clinical trials will be the basis to advance candidate compounds for further clinical development (i.e., additional Phase I, Phase II/III clinical trials), and submitted ultimately to the FDA in support of a New Drug Application (NDA) or Biologics License Agreement (BLA) submission.

2. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ 10,000.00 (minimum) nor more than a total of $ 233,227,446.00 (maximum) for successful performance of this contract.

b. This Indefinite Delivery, Indefinite Quantity (ID/IQ) contract has a total ordering period of 10 years. As necessary, NINDS will issue Task Orders for the Contractor to perform any or all of the Performance Activities listed in the Statement of Work (SOW). For this IDIQ award, the NINDS intends to issue Task Order #001 concurrent with this award. This will be a fixed-price type task order for a kickoff meeting and project management plan. Payments will be made upon delivery and acceptance of these deliverables. Task Orders for clinical trials will be competed through Task Order Request for Proposals (TORFPs) as the need arises and will consist of a base requirement for "protocol development and trial preparation" and include a quantity type option for actual conduct of the trial called "trial implementation." NINDS anticipates issuing approximately 4-6 TORFPs during each year of the contract. The amount of work will depend upon the needs of NINDS and the availability of funds. The amount of work may vary from year to year. Due to changes in priorities within NINDS, the projected workload cannot be precisely described for each year.

c. The costs set forth in this ARTICLE will cover the estimated contract period 04/01/2025 through 03/31/2035.

d. The Government will compete and award Task Orders based on the work described in SECTION C of this contract.

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

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.

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.

a. Non-Personal Services and Inherently Government Functions Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor.

If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

b. Site Visits The NINDS reserves the right to make visits to the Contractor facility, as needed. Contractor shall be responsible for making the facility available for a visit and arranging meetings with appropriate personnel.

c. Ramp-On Procedures The Government may periodically review the total number of contractors participating under the IDIQ to ensure that adequate capacity and competition exists for task orders throughout the IDIQ period of performance. Over time, the total number of contractors participating under this program may fluctuate due to various reasons including, a contractor's ability to perform, industry consolidation, significant changes in program direction and/or priorities, technology advances in drug development processes or procedures, general economic conditions, or other reasons.

If it is determined to be in the best interest of the Government to re-open the IDIQ to new contractors, the Government will announce an open season and solicit new offers by issuing a Request for Proposals (RFP) at any time during the IDIQ period of performance. This re-opening procedure is referred to as "Ramp-On."

Any Ramp-On decision will be advertised via a Request for Proposals (RFP) availability notice that will be published at SAM.gov. The RFP availability notice will provide an estimate of the RFP release and closing dates and the number of new awards that the Government intends to make. The Ramp-On solicitation and the review and award selection process will be subject to all applicable federal procurement laws and regulations. Any offeror meeting the eligibility requirements as may be identified in the RFP may submit a proposal.

Any resultant contract award will not extend beyond the period of performance remaining under the IDIQ nor exceed the maximum order total as currently established for this program. In addition, any new contractor will be eligible to compete for future task orders with the same rights and obligations of any of the other existing contractors under the IDIQ.

d. The following research is not anticipated to take place under this contract:

Human fetal tissue Human Stem Cell Research Recombinant or Synthetic Nucleic Acid Molecules Large-scale Human or Non-Human Genomic Data HeLa Cell Whole Genome Sequence Data Agent or Toxin that is Listed in the U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC) Highly Pathogenic Agent

e. Manuscripts and press releases Manuscripts for scientific publications and press releases shall be considered to include the public release of information to any medium. The Contractor shall not submit a final manuscript or publish a press release related to this contract without receiving prior concurrence from the Contracting Officer's Representative (COR). The Contractor shall submit an advance copy of the document to the Contracting Officer and COR. Upon acknowledgment of receipt, the COR will have ten (10) working days to respond with concurrence or comments. In the event that the COR does not communicate concurrence or comments to the Contractor within ten (10) working days following acknowledgement of receipt of the advance copy, concurrence may be presumed.

f. Materials Transfer Agreement A Materials Transfer Agreement (MTA) may be necessary to implement with the Contributor/sponsor in order to transfer the investigational agent substance (as API or as final dosage formulation) to the Contractor.

Investigational agents will be provided by either the Government via a 3rd party contractor or Contributor. The Contractor shall comply with FDA regulations and Contractor's SOPs for handling investigational agents. The Government or Contributor may request that the Material Transfer Agreement be put into place.

g. Paperwork Reduction Act Work under any clinical study task order will involve the collection of information from 10 or more individuals as part of clinical trial conduct. The information and statements collected will be obtained from individuals under treatment or clinical examination in connection with research on or relating to a clinical disorder. Thus, in accordance with 5 CFR 1320.3(h)(5), work under the clinical study task orders may be eligible for a Clinical Exemption from the OMB Clearance requirements as set forth in the Paperwork Reduction Act Clause, HHSAR 352.201-70 made a part of this contract. In order to obtain clinical exemption, specific protocols, including descriptions of eligibility criteria, recruiting methods and the populations and conditions to be studied, informed consent documents, etc., will be submitted to the NIH Clinical Exemption Review Committee (CERC). The COR will apply for clinical exemption for clinical study task orders once protocols are developed. A clinical exemption will need to be approved before data collection activities can begin in performance of the trial itself.

h. Data Rights All data and the results emanating from or generated on the compounds provided by the Government, along with any summary reports compiled, are considered confidential based on the pre-existing agreements that the NINDS has established with compound sponsors. The contract restricts and prohibits the Contractor's right to use, release to others, reproduce, distribute or publish data or other information resulting from testing/evaluations performed under contract. Such data shall not be releasable under the Freedom of Information Act (FOIA) as it is considered proprietary, i.e., trade secrets, and, therefore, could be determined to be exempt from FOIA. Restricted access to data and materials will be maintained at the Contractor's facility in a secured manner. Special notices or other safeguards will be affixed to any packages containing such data.

i. Electronic Submission of Payment Requests 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

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 08/07/2024 , attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

1. REPORTING REQUIREMENTS

All reports shall be submitted electronically. [In addition, one hardcopy of each report shall be submitted to the Contracting Officer.]

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."

a. Technical Reports

Contract Initiation

(1) Contract Project Management Plan: Comprehensive plan for managing all in-house and subcontracted work under the parent contract, including but not limited to work breakdown structures, timelines, key milestones and deliverables, Go/No-Go decision points, resource allocation, budget, intellectual property terms, and a risk mitigation plan.

Base Requirement - Protocol Development and Trial Preparation

(1) Final Protocol and Any Related Amendments/Modifications: Description of the trial's design, objectives, and methodology, including any changes made to the original protocol throughout the study. Must include all required regulatory forms for contributor to obtain open IND for proposed trial (e.g., FDA Form 1571 and 1572) and evidence of IRB approval.

(2) Task Order Project Management Plan: Outlines the Contractor's strategy for managing the trial, including but not limited to timelines, resources, responsibilities, risk management, and communication to ensure effective execution and oversight. Must be a single, well-organized document that addresses all elements described in the SOW.

(3) Subcontract Management Plan: Contractor's plan for executing any subcontracted work involved in the trial, including but not limited to how qualified subcontractors will be identified, how studies will be scheduled to meet NIH timelines, and how subcontractors will be managed and overseen.

(4) Clinicaltrials.gov Registration: Contractor must register each trial in the National Library of Medicine's Clinical Trials registry, which provides a public record of the study's design, goals, and status to enhance transparency and adherence to regulatory requirements.

Quantity Option - Trial Implementation

(1) Summary Report for Each Clinical Trial Initiation Meeting: Must include list of participants and summarize the meeting agenda, including key discussions, decisions, and action items, ensuring that all parties are aligned on trial objectives and procedures.

(2) Draft Clinical Study Report: Includes preliminary findings and analyses of the clinical trial, pending further review and updates before finalization. Study report must be in a format suitable for submission to the FDA unless otherwise specified.

(3) Final Clinical Study Report: Provides a thorough summary of the clinical trial's methods, results, and conclusions, including all data and analyses, after final revisions. Study report must be in a format suitable for submission to the FDA unless otherwise specified.

(4) Final Inclusion Enrollment Report: Includes the final number and characteristics of participants enrolled in the trial, confirming adherence to the study's enrollment criteria and goals.

(5) Annual Report for Each IND Application: Provides a detailed account of the progress, safety, and findings related to the Investigational New Drug (IND) application.

(6) Final Statistical Analysis Plan: Specifies the statistical methods and procedures to be used for analyzing the trial data, ensuring consistency and rigor in data interpretation.

(7) Final Bioanalytical Report: Summarizes the results of bioanalytical testing, including data on the validation, accuracy, and reliability of the assays used during the trial.

(8) Finalized Database Provided to Contributor/Sponsor: The completed and validated database containing all trial data. Must deliver the locked deidentified database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR.

(9) Annual Technical Progress Report for Clinical Research Study Populations:

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "PHS Human Subjects and Clinical Trials Information Form-H," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website:

https://grants.nih.gov/policy/inclusion/women-and-minorities.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender, race and/or ethnicity.

b. Other Reports/Deliverables

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.)

Service Contract Annual Report In accordance with FAR 52.204-15 Service Contract Reporting Requirements for Indefinite- Delivery Contracts, "which is incorporated into the contract, the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2), the following information to http://www.sam.gov, with an electronic copy to the Contracting Officer:

https://grants.nih.gov/policy/inclusion/women-and-minorities.htm https://www.ecfr.gov/current/title-45/part-94

1) Contract number and order number.

2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

4) Data reported by subcontractors [if applicable] under paragraph (f) of the subject clause (see full text of clause FAR 52.204-15, "Service Contract Reporting Requirements for Indefinite- Delivery Contracts" at https://www.acquisition.gov/).

Subcontracting Reports The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR) Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR) Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

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

Contracting Officer e-mail: [To be specified prior to award of the contract].

Invention Reporting Requirement All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/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 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 https://www.acquisition.gov/ http://www.esrs.gov/ to the Contracting Officer on the expiration date of the contract.

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

Contracting Officer:

[To be specified at time of award]

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

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

Section 508 Annual Report The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.section508.gov/sell/acr/.

Multiple Principal Investigators Leadership Plan The Contractor must submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract.

The revised plan is subject to review and approval by the Contracting Officer.

Contract Closeout Documents In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for and provide the following items:

i. Indirect cost rate proposals for all years (in which a proposal was not previously submitted);

ii. Final property inventory (excluding intellectual property) and Standard Forms 1428 and 1429 (if applicable);

iii. Settling all subcontract costs and any issues thereunder;

iv. Subcontracting compliance reports for all years to the electronic subcontract reporting system at https://www.esrs.gov (if applicable);

http://www.iedison.gov/ https://www.section508.gov/sell/acr/

v. Final patent and royalty reports;

vi. A contractor's release of claims, i.e., Contractor's closing statement; Contractor's Assignment of Refunds, Rebates, and Credits; and

vii. A final invoice or completion voucher.

SECTION D - Packaging and Marking

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.

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) (Refer to Article G.1.) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health 6001 Executive Boulevard Rockville, MD 20892

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

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

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

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The estimated ordering period of this contract shall be from 04/01/2025 through 03/31/2035. The period of performance shall be specified for any individual resultant task orders issued.

2. DELIVERIES

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

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

Item Description Quantity Delivery Schedule

A: Contract Initiation Deliverables

(1) Contract Project Management Plan

1 e-copy to CO and

COR

Within 60 days of contract award

B: Deliverables for Base Requirement - Protocol Development and Trial Preparation

(1)

Final protocol and any related amendments/ modifications

1 e-copy to COR

Final Protocol - within 3 weeks of Task Order award

Amendment/modification

- within 3 weeks of COR request

(2) Task Order Project Management Plan 1 e-copy to COR

Within 60 days of Task Order award and before dosing of the first subject

Item Description Quantity Delivery Schedule

(3) Subcontract Management Plan 1 e-copy to COR Within 60 days of Task

Order award

(4) Clinicaltrial.gov registration 1 e-copy to COR

Within 60 days of Task Order award and before dosing of the first subject

C: Deliverables for Quantity Option - Trial Implementation

(1) Summary Report for each Clinical Trial Initiation meeting

1 e-copy to COR Will be determined by terms of each individual Task Order

(2) Draft clinical study report 1 e-copy to COR Within 45 calendar days of locking database

(3) Final clinical study report 1 e-copy to COR

Within 15 calendar days of receiving comments from the NINDS and/or its Contributor/Sponsor

(4) Final Inclusion Enrollment Report 1 e-copy to COR Within 30 days last subject's last study visit

(5) Annual report for each IND application 1 e-copy to COR Within 7 days of submission to FDA

(6) Final Statistical Analysis Plan 1 e-copy to COR Within 2 months of last subject's last visit

(7) Final Bioanalytical Report 1 e-copy to COR Within 2 months of last subject's last visit

(8) Finalized database provided to Contributor/Sponsor

1 e-copy to COR Within 2 months of last subject's last visit

(9)

Annual Technical Progress Report for Clinical Research Study Populations

1 e-copy to COR On or before the anniversary date of Task Order award

D: Administrative and Regulatory Reports

(1) Reporting of Financial Conflict of Interest

(FCOI)

1 e-copy to CO See Article C.2(b)(1) for details.

Item Description Quantity Delivery Schedule

(2) Service Contract Annual Report

Electronic Submission (external)

October 31st following each contract year

(3) Individual Subcontract Reports

(ISR)

Electronic Submission (external)

April 30th and October 30th of each contract year; and a final report on or before expiration date of contract.

(4) Summary Subcontract Report

(SSR)

Electronic Submission (external)

October 30th of each contract year.

(5) Annual Invention Utilization Report 1 e-copy to CO

On or before the anniversary date of contract award

(6) Final Invention Statement 1 e-copy to CO

On or before the expiration/ termination date of the contract

(7) Section 508 Annual Report

1 e-copy to CO and

COR

On or before the anniversary date of contract award

(8) Revised Leadership Plan

1 e-copy to CO and

COR

If Contractor is using multiple principal investigators (PIs) and there is a change in any of the PIs named in the Key Personnel Article in SECTION G of this contract.

(9) Contract Closeout Documents 1 e-copy to CO Upon/after contract completion

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

Addressee Deliverable Item No Contracting Officer A1, D1, D5-D9 Contracting Officer's Representative (COR) A1, B1-B4, C1-C9, D7-D8

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: TBD

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

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs.

However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

• Understanding of the requirements;

• Experience and capability on similar tasks;

• Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies;

• Procedures for assuring quality of work, products, and deliverables;

• Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

• Staffing plan with skill levels and level of effort for each individual proposed.

Generally, resumes will be required for proposed personnel (if not previously submitted);

• References to evaluate past performance; and

• Cost/Price to perform the task order.

d. 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 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 whose proposal is most advantageous to the Government

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

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued exceeding the micro-purchase threshold issued under multiple delivery-order contracts or multiple task-order contracts, except:

i The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

i For orders exceeding the micro-purchase threshold up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

ii For orders exceeding the simplified acquisition threshold up to $5.5 Million, in accordance with 16.505(b)(1)(iii); and, iii For orders exceeding $5.5 Million, in accordance with FAR 16.505(b)(1)(iv).

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

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 with a copy of the invoice to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name- TBD Email Address- [ ]

Contracting Officer Representative

Name- TBD Email Address- [ ] https://www.ipp.gov/

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Office of Acquisition (NIDA_INV_NINDS).

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.