RFP_75N95023R00019.pdf

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95023R00019

NIDA Reference Number: N01DA-23-8939 “Toxicological Evaluations of Potential Medications”

Issued by:

Joshua T. Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive – Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

DATE ISSUED: Friday, February 17, 2023 PROPOSAL DUE DATE: Monday, April 3, 2023, 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. 75N95023R00019 titled “Toxicological Evaluations of Potential Medications ".

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 http://www.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 indefinite delivery indefinite quantity (task order) type contract with individually negotiated task orders over a five-year period of performance.

Cost reimbursement and/or firm fixed price task orders are expected to be awarded concurrently with and after contract award. All funding will be made through issuance of task orders and will be dependent on program needs and funding availability. The contract will contain a minimum of $1,000 (minimum funded by task orders concurrent with award) and a maximum of $9,750,000 (maximum) for the entire contract period.

Offerors should respond with technical and pricing proposals based on the assumptions provided in Section C and L. Offerors must include all of the tasks listed in Task Requirements found in the Statement of Work of the RFP in your technical proposal.

Please include separate pricing for each of the four sample task orders A, B, C, D, E and F.

http://www.sam.gov/ http://www.sam.gov/

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 polina.klimenkova@nih.gov by Monday, March 13, 2023. 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.

Requests for Information (RFIs)

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. RFIs must be submitted on or before 3:00 p.m. on Monday, March 3, 2023.

RFIs may be submitted by e-mail to polina.klimenkova@nih.gov with the subject line “RFI – RFP 75N95023R00019”.

NOTICE: A permanent approval for class deviations to FAR 52.227-11, Patent Rights and FAR Clause 52.227-17, Rights in Data- Special Works was issued for use by NIDA when procuring contracts for confidential routine screening, pharmacokinetic, pharmaceutic and product development services for compounds under NIDA’s Medication Development Program. NIDA intends to include these clause deviations in any resulting contract from this solicitation. The deviation clauses are set forth in ARTICLE I.4 of this solicitation.

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 Attachments.

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

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than Thursday, April 3, 2023 at 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 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 SAM.

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 Polina Klimenkova, NIDA Section, Contracts Management Branch Red who may be reached by e-mail at polina.klimenkova@nih.gov. Discussions with any other individual outside the NIDA Section, Contract’s Management Branch Red should not occur.

Sincerely, Josh Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisitions, NIDA/NIH

Enclosure https://ecps.nih.gov/ https://ecps.nih.gov/home/howto https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps mailto:polina.klimenkova@nih.gov

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 102-321 as amended

2. Request for Proposal (RFP) Number:

75N95023R00019

3. Issue Date:

2/17/2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Toxicological Evaluations of Potential Medications

6. ISSUED BY:

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

NIDA 3WFN MSC 6023

16071 Industrial Drive Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3 pm local time on 4/3/2023. 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 to be submitted via the electronic Contract Proposal (eCPS) website at https://ecps.nih.gov as stated in ATTACHMENT 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." 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: Josh Lazarus, Contracting Officer

PHONE: (301) 443-6677

e-MAIL: josh.lazarus@nih.gov

- 2 -

1. Requisition or other Purchase Authority: Public Law 102-321 as amended

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be submitted via email to olina.Klimenkova@nih.gov on or before 3:00 P.M. ET on 03/03/2023. All such emails must contain the subject line:

"RFI - RFP 75N95023R00019".

Josh Lazarus Contracting Officer

N01DA-23-8939 : 75N95023R00019

- 3 -

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. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

- 4 -

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

16. 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. Cost and Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. 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 DATA SHARING PLAN

6. TECHNICAL EVALUATION FACTORS

7. PAST PERFORMANCE FACTOR

- 5 -

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 (IF REQUIRED) 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

This research and development contract will support pre-clinical acute and repeat dose toxicology and safety pharmacology studies in rodents, rabbits, dogs, and/or monkeys, which support the development of potential pharmacotherapies (medications) to treat substance use disorders. This contract also will support drug interaction studies in rodents, rabbits, dogs, and/or monkeys to assess the safety of potential medications when administered alone and in combination with abused substances.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,000 (minimum) nor more than a total of $9,750,000 (maximum) for successful performance of this contract.

b. For cost reimbursement task orders, the fixed fee for individual task orders will be negotiated by task order. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work or the percent of total effort expended), as determined by the Contracting Officer, and 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. Payment of fixed fee shall not be made in less than monthly increments.Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item and FAR Clause 52.217-9, Option to Extend the Term of the Contract Priced Line Item, set forth in ARTICLE I.3. and ARTICLE I.4. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Quantities specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given 15 calendar days before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The price of the task order will be increased as negotiated and set forth in the individual task Orders.

c. The costs/prices set forth in this ARTICLE will cover the five-year contract ordering period.

d. The Government will issue cost reimbursement and/or fixed price 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.

- 6 -

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.

- 7 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK (SOW)

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 02/09/2023, 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 electronically 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

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. Note: the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

For proposal preparation purposes only, it is estimated that these reports will be required as follows:

[X] Monthly [X] Annually [X] Final - Upon final completion of the contract

1. Monthly Progress Reports: Within the first 5 calendar days of each month of contract work, the Contractor shall provide a comprehensive report on activities during the previous month. This report shall contain a detailed list of all tasks/studies to date authorized or in the planning stage including for each study: study number, study title, study director, protocol signature date, in-life start and termination dates (anticipated or completion), draft report (anticipated or completion) date, final report (anticipated or completion) and relevant details relating to progress such as problem areas or unexpected findings. The Contractor shall issue one each electronic copy of the Monthly Progress Report as an Adobe PDF file and Microsoft Word DOC file to the NIDA COR.

2. Annual Progress Reports: Not later than 15 business days after the end of each year of contract work, the Contractor shall provide a comprehensive report on activities during the year. This report shall contain a detailed list of all tasks/studies authorized during the year including for each study: study number, study title, study director, protocol signature date, in-life start and termination dates (anticipated or completion), draft report (anticipated or completion) date and final report (anticipated or completion) date. The Contractor shall issue one each electronic copy of the Annual Progress Report as an Adobe PDF file and Microsoft Word DOC file to the NIDA COR to the Contracting Officer. The Annual Progress report for the last year of the contract shall be incorporated into the Final Report.

3. Final Report for the Contract: This report summarizes overall accomplishments of the contract period. NIDA requires this report upon contract completion. The Contracting Officer receives one electronic copy as an Adobe PDF https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents

- 8 -file of the final report. The Contractor shall issue one electronic copy in Adobe PDF format and one electronic copy in MS Word format to the NIDA COR.

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.

b. Other Reports/Deliverables

1. Laboratory Records, Specimens and Raw Data:

The Contractor, if authorized by the NIDA COR, shall archive or deliver these items to an Archive designated by the NIDA Contracting Officer on or before contract expiration. NIDA shall pay for shipment of the items.

The Contractor is responsible for packaging and inventory of the items. In the event that all or part of the study records are not to be archived, the Contractor destroys the specified documents/specimens.

2. Draft Study Protocols:

The Contractor shall provide the NIDA COR with a Draft Study Protocol within 5 business days of the COR's request. Overall, the protocol shall be conducted in the spirit of GLP guidelines and have a clearly written section that describes appropriate statistical methods for analyzing the experimental data. The protocol shall set forth the experimental and reporting designs in clear detail and be free of ambiguities, typographical errors and contradictions. In-text tables shall be used to supplement explanations provided in the text of the protocol. The draft protocol shall clearly state the anticipated study schedule, including animal arrival, treatment phase, ante-mortem evaluations, disposition of the animals after the study and report preparation. The Contractor shall make NIDA-specified changes to Draft Study Protocols and respond within 3 business days of the COR's request. The protocol may be revised multiple times before it is acceptable to the NIDA.

3. Final Study Protocols:

The Contractor shall make NIDA-specified changes to Draft Study Protocols, providing the NIDA COR with a Final Study Protocol within 2 business days of request.

4. Draft Study Reports:

The Contractor shall provide the NIDA COR with a Draft Study Report within 1 month after completion of all evaluations for studies of less than two weeks duration. For studies of two weeks to 6 weeks duration the report shall be provided within 2 months after completion of the experimental evaluations. For studies greater than 6 weeks duration the report shall be provided within 4 months after completion of the experimental evaluations. Each study shall have a separate report. The report shall be free of grammatical and typographical errors, shall be clear, and shall be concise and structured like a manuscript for a reviewed pharmacology or toxicology journal. It shall include a title page, abstract, introduction, methods, results, discussion, summary and bibliography or references. Tables and/or figures shall be included after the bibliography, along with a legend page. The report may be submitted by NIDA to the FDA. These reports must conform to the general requirements (style and content) necessary for documentation submitted in support of an IND or NDA. Moreover, they shall conform to the minimum standards set forth by GLP guidelines.

5. Final Study Reports:

The Final Study Report shall be issued within 10 business days of the COR's request. The Final Study Report shall be issued within 10 business days of the COR’s request. It shall conform to GLP Guidelines. The Contractor shall issue one each electronic copy of the complete final report as an Adobe PDF file and as a Microsoft Word DOC file. The reports shall include all tables and appendices. The Contractor shall post the electronic versions of the Final Study Report, including all tables and appendices, in an Adobe PDF file and as a Microsoft Word DOC file to NIDA’s secure server (e.g., Livelink), and The Contractor shall provide a complete set of all data tables as separate files. The posted data tables shall be in a format such that the data can be

- 9 -exported or copied (that is, not PDF or an image format) into other computer programs, such as Microsoft Excel and GraphPad Prism, for possible subsequent analysis by NIDA. In addition, the Contractor shall deliver to the NIDA COR the Final Study Report, including all tables, figures, graphs and appendices, as an Adobe PDF file and as a Microsoft Word DOC file, and the raw data tables in a format that can be exported or copied (that is, not PDF or an image format) into other computer programs, such as Microsoft Excel and GraphPad Prism on electronic storage media such as an external hard drive CD, DVD, USB flash drive or SD card a CD or DVD with the Final Study Report.

Note: 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 shall be submitted with the date of the revision.

6. Task Order Final Report:

The requirements for the final report for each awarded task order will be specified in the task order issued by

NIDA.

7. 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 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: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 . See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, 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.

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.

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.iedison.gov

- 10 -

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.

- 11 -

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, Contracting Officer's Representative (See Article G.1) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive – Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

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).

For Fixed-Price Task Orders Only:

FAR Clause 52.246-16,Responsibility for Supplies (April 1984)

- 12 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The ordering period of this contract shall be from September, 2023 through September, 2028.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work 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 and anyway else in this contract will be required to be delivered electronically and and "F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984)," in accordance within accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

1. Monthly Progress Report TO COR: 1 in PDF & 1 in

Microsoft Word.

Within 5 calendar days of each month of contract work.

2. Task Order Final Report TO COR:1 in PDF & 1 in Microsoft Word; TO CO: 1 electronic copy in PDF.

As specified in each Task Order issued by NIDA.

3. Annual Progress Report TO COR: 1 in PDF & 1 in Microsoft Word; TO CO: 1 electronic copy in PDF.

Within 15 business days of the end of each contract year.

4. Final Contract Report w/ Summary of Salient Results

TO COR:1 in PDF & 1 in Microsoft Word; TO CO: 1 electronic copy in PDF.

On or before contract expiration.

5. Laboratory Records, Specimens and Raw Data

All electronic copies to

COR.

On or before contract expiration.

6. Draft Study Protocols TO COR: For details, see "Other Technical Reports/ Deliverables" in

ARTICLE C.2.

Within 5 business days of COR's request.

7. Final Study Protocols TO COR: For details, see "Other Technical Reports/ Deliverables" in ARTICLE C.2.

Within 2 business days of COR's request.

8. Draft Study Reports TO COR: For details, see "Other Technical Reports/ Deliverables" in ARTICLE C.2.

See Article C.2 b(4)

9. Final Study Reports TO COR: For details, see "Other Technical Reports/ Deliverables" in ARTICLE C.2.

Within 10 business days of COR's request.

10. Reporting of Financial Conflict of Interest (FCOI)

TO CO: One copy in electronic format.

See ARTICLE C.2(b)7 for details.

11. Annual Utilization Report TO CO: In electronic format (PDF or Microsoft Word).

Annually on contract anniversary date.

12. Final Invention Statement TO CO: One in electronic format.

By contract expiration date.

- 13 -

Item Description Quantity Delivery Schedule

13. Small Business

Subcontracting Reports TO CO: Electronically via Electronic Subcontracting Reporting System (eSRS).

By 4/30 and 10/31 of each contract year.

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).

ARTICLE F.3. 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.

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

- 14 -

SECTION G - CONTRACT ADMINISTRATION DATA

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

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

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 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

TBD

ARTICLE G.3. TASK ORDER PROCEDURE

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

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed

- 15 -

Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

c. Evaluation and Award of Task Order Proposals

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

Specifically, the technical evaluation factors, cost/price, and any other factor specifically identified in theTORFP 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.

ARTICLE G.4. 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.

1. PLEASE NOTE: NIH invoicing is in the process of moving to the Invoice Processing Platform (IPP).

Two sets of invoice instructions are included in this document. Please follow the NIH Invoice and Payment Provisions dated February 10, 2021 and Submitting Electronic Invoices to OFM until you are notified in writing by the Contracting Officer that your contract has been converted to the IPP.

- 16 -

The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

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

Approving Official: Contracting Officer

Name- TBD Email Address-

Contracting Officer Representative

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.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. [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. 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.

https://www.ipp.gov https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

- 17 -

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:

Toxicological Evaluations of Potential Medications

g. Contract Line Items shall be established through the award of individual Task Orders.

ARTICLE G.5. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, 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 shall submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

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

Approving Official: Contracting Officer

Contracting Officer Representative

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.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.

ARTICLE G.6. 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.

https://www.ipp.gov https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com

- 18 -

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.7. 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.