RFP 75N95024R00011 (002).pdf

OMB #0990-0115

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95024R00011

NIDA Reference Number: N01DA-24-8950 “Medication Discovery Using Rat Models of Relapse”

Issued by:

Tracy Cain, Contracting Officer NIDA Office of Acquisitions Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

National Institutes of Health 10671 Industrial Drive – Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

Point of Contact: Llakim Dubroff, Contract Specialist E-Mail: llakim.dubroff@nih.gov Phone: (301) 443-6677

DATE ISSUED: Friday, February 16, 2024

PROPOSAL DUE DATE: Monday, April 1, 2024, 3:00 P.M. Eastern Time

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00011 titled “Medication Discovery Using Rat Models of Relapse.”

Please refer to Section M for mandatory criteria. Additionally, all offerors must be REGISTERED and have an ACTIVE System for Award Management "http://www.sam.gov/" (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management https://sam.gov/ (www.sam.gov) must be in full compliance with FAR 52.204-7 System for Award Management and FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

NIDA expects to award a single, cost reimbursement, level of effort type contract with a base period of performance of twelve (12) months with four (4) additional twelve (12) months option periods up to a total potential performance period of five years with additional option quantities. The initial performance period will start on or around July 10, 2024. You should respond with technical and cost/price proposals based on the mailto:llakim.dubroff@nih.gov https://sam.gov/ assumptions provided in Section C and L. Please include separate cost/prices for the base award and each of the options listed in Articles B.2. and B.3.

General

Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 2 is a "Proposal Intent Response Sheet." Please complete this form and return it llakim.dubroff@nih.gov by Friday, March 08, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information.

The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Furnish in writing (e-mail is acceptable) to the Contracting Officer any areas of uncertainty, which, in your opinion, require clarification or correction. You must submit your questions in sufficient time for receipt by the Contracting Officer on or before 3:00 p.m. March 08, 2024. Mark the e-mail, "Offeror's Questions, RFP No. 75N95024R00011."

The Business Proposal

The Business Proposal must contain a detailed breakdown of costs by task, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. Please utilize the Breakdown of Proposed Estimated Costs and Excel spreadsheet contained in Attachment 10.

A completed Form NIH-2043, “Proposal Summary and Data Record” must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Travel Policy, Total Compensation Plan, Small Business Subcontracting Plan, and Annual Report with the initial Business Proposal (See Section L.2.c.

for additional detail).

The Technical Proposal

Offerors shall complete and attach the “Technical Proposal Cover Sheet” to their technical proposal. Be sure to list all professional personnel and organizations named in the proposal who have any role in the proposed work including staff, subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be shown for each person named. If needed, additional sheets may be included using the same format. This information is vital to ensure that no conflicts of interest exist with the review committee members.

Format and content requirements for the Technical Proposal are detailed in Section L.2.b.

mailto:llakim.dubroff@nih.gov http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than Monday, April 1, 2024, 3:00 P.M. Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly. Additional instructions on how to submit a proposal via eCPS can be found at https://ecps.nih.gov/home/howto and in Attachment 01.

All notices related to this solicitation will be posted on https://sam.gov/ (www.sam.gov) as well as the NIDA Contracts Home Page (https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). If you would like to receive e-mail notifications of updates to this solicitation, please register with Beta.SAM.gov.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers

This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The National Institute on Drug Abuse appreciates your interest in this RFP and looks forward to receipt of your proposal. Requests for any information concerning this RFP should be directed to Llakim Dubroff, at the NIDA Section, Contracts Management Branch Red, who may be reached at (301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Sincerely, Tracy Cain, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisitions, NIDA/NIH

Enclosure https://ecps.nih.gov/home/howto https://sam.gov/

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321

2. Request for Proposal (RFP) Number:

75N95024R00011

3. Issue Date:

02/16/2024

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Medication Discovery Using Rat Models of Relapse

6. ISSUED BY:

NIDA Office of Acquisitions Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

National Institutes of Health 10671 Industrial Drive - Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 3:00 PM local time on 04/01/2024.

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 ATTACHMENT 1, Proposals submitted by any other means such as facsimile, hard copy or e-mail will not be accepted.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal and continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation.

Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration.

11. FOR INFORMATION CALL: Llakim Dubroff, Contract Specialist

PHONE: 301-443-6677

e-MAIL: llakim.dubroff@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Tracy Cain Contracting Officer Office of Acquisitions

NIDA Reference No. N01DA-24-8950 : 75N95024R00011

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

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

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

In brief, the objectives of this contract are to determine the in vivo efficacy of novel compounds in animal models of relapse. This includes the following tests in animals trained to self-administer cocaine or other drugs of abuse;

(1) the ability of a test compound to block or reduce footshock- or other stressor-induced reinstatement of responding after a period of experimental extinction, (2) the ability of a test compound to block or reduce drug-priming-induced reinstatement of responding after a period of extinction, and (3) the ability of a test compound to block or reduce the effects of a conditioned cue (previously paired with drug) to reinstate responding for cocaine after a period of extinction.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . 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 contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract 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

Option Period 1

Option Period 2

Option Period 3

Option Period 4

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Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Total [Base Period and Option(s)]

e. If the Government exercises any of its option quantities pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract 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 ($)

Option Quantity 1

Option Quantity 2

Option Quantity 3

Option Quantity 4

Total Option Quantities:

f. “Ultimate Contract Value (Base Period, Option Periods, and Option Quantities):" to describe the total value.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

[Remainder of Page Intentionally Left Blank]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated TBD, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted in electronic format, as specified in Section F of the RFP.

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 Progress Reports

1.) In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation.

These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

2) Study Reports: For each compound evaluated in Task 1, the Contractor shall submit one electronic copy of a Study Report to the NIDA COR within 30 days of the completion of each compound studied. The purpose of these reports is to inform DTMC, as well as the submitter whose compound is being tested, of the results obtained. These reports shall accurately and completely outline the results of each individual test on each test compound.

A prototype of this report will be provided to the Contractor by the NIDA COR. The format of the Study Report shall include: Date of report, title (to include test compound identification number/batch number), experimental protocol utilized (e.g., Stress-induced reinstatement to cocaine self-administration), NIDA DTMC Contract number (TBD), Contractor name(s), abstract of methods and experimental findings, detailed methods, methods of data analysis, description of compound(s) and vehicle(s) utilized, detailed description of experimental results including calculation of compound potency and presentation of data in graphical and/or tabular form for the group of experimental subjects.

The Contractor shall ensure that all Study Reports are free from spelling, typographical, or grammatical errors.

Study Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. A revised report will be submitted with the date of the revision. Study reports will be transmitted electronically as specified by the NIDA COR.

3.) Monthly Progress Reports: Within the first five working days of each calendar month, the Contractor shall submit one electronic copy of a report on activities during the preceding month. In the Monthly Progress Report, the Contractor shall briefly summarize (1-2 paragraphs) results in the different behavioral tests and include a discussion of any problems encountered and recommendations to rectify the problem(s). This report shall include a listing of any formal correspondence with NIDA. The Monthly Progress Report shall also contain an updated chronological listing of compound authorization, receipt, usage and evaluation relevant to the month under report.

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4.) Annual Progress Reports: Not later than fifteen working days after the end of each year of contract work, the Contractor shall submit a report on activities during the year. This report shall contain a summary of notable achievements, methods followed for each protocol, results obtained, problems encountered and their solutions, and an updated chronological listing of compound authorization, receipt, usage and evaluation during the year under report. A summary of any consultant meeting(s) held during the year should be included. An electronic copy is to be sent to the NIDA COR and one copy to the Contract Officer.

5.) Final Report: On or before the expiration date of the contract, the Contractor shall provide a comprehensive summary of work conducted during the entire contract period. This report shall incorporate the final annual report and shall contain a summary of notable achievements, methods followed for each protocol, results obtained, problems encountered and their solutions, and an updated chronological listing of compound authorization, receipt, usage and evaluation during the period under report. A summary of any consultant meeting(s) held during the year should be included. Electronic copies are to be sent to the NIDA COR and to the Contract Officer.

6.) Laboratory records and proprietary test compounds: On or before the expiration date of this contract, if so instructed by the NIDA COR, the contractor shall ship these items to the NIDA COR in Rockville, Maryland.

7.) Pre-meeting Packets: Pre-meeting packets will be prepared by the Contractor as described in Task 2. One copy shall be provided to each consultant and the remainder to NIDA COR as described in Task 2.

8.) Meeting Reports: These reports shall be prepared by the contractor as described in Task 2. Two copies shall be sent to the NIDA COR no later than 2 weeks after completion of each meeting.

b. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

c. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

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

94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

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

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

Please refer to Article F.2 and Article H.14 for HHS Security and Privacy Language for Information and IT deliverables.

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ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

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

NIDA Office of Acquisitions Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

National Institutes of Health 10671 Industrial Drive – Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

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.

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 07/10/2024 through 07/09/2025.

a. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 (Contract Year 2)

07/10/2025 – 07/09/2026

Option Period 1 (Contract Year 3)

07/10/2026 – 07/09/2027

Option Period 1 (Contract Year 4)

07/10/2027 – 07/09/2028

Option Period 1 (Contract Year 5)

07/10/2028 – 07/09/2029

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description 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 [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule

(1) Study Report 1 electronic Within 30 calendar days of study completion

(2) Monthly Progress Report 1 electronic Within 5 business days after the end of each month

(3) Annual Progress Report 2 electronic Within 15 business days following the end of each contract year, if options are exercised

(4) Final Report 2 electronic On or before contract expiration

(5) Laboratory Records & Proprietary Test Compounds

As described in Task 5 of the Statement of Work

On or before contract expiration

(6) Pre-meeting Packets As described in Task 2 of the Statement of Work

As described in Task 2 of the Statement of Work

(7) Meeting Reports 1 electronic Within 14 calendar days of meeting

(8) Summary of Salient Results

1 electronic On or before contract expiration

(9) Annual Utilization Report 1 electronic Within 15 calendar days following the end

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Item Description Quantity Delivery Schedule of each contract year, if options are exercised

(10) Final Invention Statement 1 electronic On or before contract expiration

(11) Incident Response Report 1 electronic As soon as possible, no later than 1 hour after discovery

b. In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items: Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property); standard forms 1428 and 1429 (if applicable); settling all subcontract costs and any issues thereunder; subcontracting compliance reports for all years to the eSRS; final patent and royalty reports; Contractor's release of claims, i.e. Contractor's closing statement; the Contractor's Assignment of Refunds, Rebates and Credits; and a final invoice or completion voucher (marked final).

Addressee Deliverable Item No Quantity

Contracting Officer 3-4, 8-11 1 electronic copy Contracting Officer’s Representative 1-8 1 electronic copy

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor hours. The labor hours include vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor [HOURS, MONTHS, YEARS]

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Contract Year Option Quantity 1 Option Quantity 2

Totals

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of Hours by which the number of direct labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

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

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.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 award

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

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

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

(End of clause).

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

Name Title

TBA

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for 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.

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

Official: Contracting Officer

Name- TBA Email Address- TBA

Contracting Officer Representative

Name- TBA Email Address- TBA

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 Section, Contracts Management Branch Red .

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. 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. 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. The Contract Title is:

Medication Discovery Using Rat Models of Relapse

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g. Contract Line Items as follows:

Line Item # Line Item Description

1 Base Award (Contract Year 1) Period of Performance:

07/10/2024 – 07/09/2025

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

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

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Nov 2021).

a. Upon 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.

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, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of clause).

ARTICLE G.5. INDIRECT COST RATES

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

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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work.

In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on the contract anniversary date.

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Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty 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.

b. 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

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

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

TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable:

1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103, "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102, "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https:// www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at https://grants.nih.gov/policy/reproducibility/ index.htm, including FAQs and a General Policy Overview.

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

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from any NIH-funded or conducted research, supported in whole or in part with direct costs from NIH regardless of NIH funding mechanism. NIH defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications that result from the publishing and peer review process, and which should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the award/ support period, whichever comes first. 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-21-013.html and https:// publicaccess.nih.gov/.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

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ARTICLE H.5. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF

CONTROLLED SUBSTANCES

The Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act, except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

ARTICLE H.7. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015).

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c)above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS),…