RFP 75N95023R00007.pdf

OMB #0990-0115

Request for Proposal (RFP) No. 75N95023R00007 “Receptor Binding and Predictive Toxicology”

Issued by:

Tracy Cain, Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH

NIDA 3WFN MSC 6023

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

Point of Contact: Alexander Beraud, Contract Specialist E-Mail: alexander.beraud@ nih.gov Phone: 301.443.6677

DATE ISSUED: March 10, 2023

PROPOSAL DUE DATE: April 24, 2023, 3:00 P.M. (Eastern Standard Time)

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95023R00007 for "Receptor Binding and Predictive Toxicology".

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

We expect to award an indefinite delivery, indefinite quantity (IDIQ) contract with fixed-price or cost-plus-fixed fee (completion or term form) task orders. NIDA anticipates the IDIQ contract will have an ordering period of five years and will include a guaranteed minimum of $1,000 and a maximum value of $5,000,000 for the ordering period. Task orders may include, options for extra quantities and to extend the period of performance. Future year funding will be dependent on the previous year's performance and funding availability. The initial performance period will start on or around September 21, 2023.Interested parties should respond with technical and pricing proposals for the entire project. Please include separate pricing for each individual option.

THIS IS A 100 PERCENT SET-ASIDE FOR SMALL BUSINESS. Proposals received from firms that are not small business concerns, as defined by the North American Industry Classification System (NAICS) code, are not eligible for award. The NAICS code applicable to this buy is 541715. See Section L.1.c. of this RFP.

In addition, FAR Clause 52.219-14 ‘Limitation on Subcontracting’ is applicable under this solicitation, and this clause requires that at least fifty (50) percent of the cost of contract performance incurred for personnel be expended by employees of the small business firm.

General Particularly direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award and (if negotiations are conducted) will tailor those items through final negotiations.

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (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 requirements.

You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs by year and individual options, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. We direct special attention to the Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 08. Please provide an electronic copy of the spreadsheet in this format. Do not send encrypted files. Use of the above format will hasten review and award. See Section L.2.c. Business Proposal Instructions for additional detail.

Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Format and content requirements of your Technical Proposal are detailed in Section L.2.b. Technical Proposal. Also, you should complete the “Technical Proposal Cover Sheet” and use it as the cover sheet for each copy of your technical proposal. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. We will use this information to ensure that no conflicts of interest exist with the selected review committee members.

The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal.

If you want to receive an e-mail notice of any amendments to this RFP, you should register on the SAM.gov website. Also, NIDA will post all amendments, or provide an appropriate link, on the SAM.gov website.

Offeror Questions and Intent Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist and Contracting Officer. A completed "Proposal Intent Response Sheet."

Attachment 02 of the RFP: Please complete this form and return it to this office on or before March 24, 2023.

The Completed Proposal Intent Response Sheet and offeror questions, if any, must be submitted on or before 5:00 P.M. Eastern Time on April 17, 2023. The response sheet and offeror questions must be submitted by e-mail to alex.beraud@nih.gov and tracy.cain@nih.gov with the subject line: “Offeror Intent and Questions – RFP75N95023R00007”

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and no later than 3:00 p.m., Eastern Standard Time (EST) on April 24, 2023. 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 submitting a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 1.

All notices related to this solicitation will be posted on SAM (https://www.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.

Following your proposal submission and our review, the Contracting Officer may seek more information. In accordance with FAR 15.306(a)(3) and FAR 52.215-1, we advise you that the Government intends to evaluate proposals and award a contract without discussions (except clarifications). Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. However, we reserve the right to conduct discussions if the Contracting Officer later decides them to be necessary.

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

Requests for any information concerning this RFP should be directed to Alexander Beraud, NIDA Office of Acquisitions, Red Branch, who may be reached on (301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA R&D Contracts Management Branch should not occur.

Sincerely yours, Tracy Cain, Contracting Officer Contracts Management Branch, Red Email: tracy.cain@nih.gov

Enclosure

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

75N95023R00007

3. Issue Date:

03/10/2023

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : Receptor Binding and Predictive Toxicology

6. ISSUED BY:

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

NIDA 3WFN MSC 6023

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

7. SUBMIT OFFERS TO:

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at 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 03:00 PM EST local time on 04/24/2023. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal and shall continue to be registered until the time of award, during performance, and through final payment of any contract resulting from this 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 and https:// www.sam.gov for information on registration.

11. FOR INFORMATION CALL: Alexander Beraud, Contract Specialist

PHONE: (301) 827-6857

e-MAIL: alexander.beraud@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

https://www.sam.gov https://www.sam.gov

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

The completed Proposal Intent Response Sheet and offeror questions, if any, must be submitted on or before 5:00 P.M.

Eastern Time on April 17, 2023. The response sheet and offeror questions must be submitted by e-mail to alex.beraud@nih.gov and tracy.cain@nih.gov with the subject line: "Offeror Intent and Questions

RFP75N95023R00007"

Tracy Cain Contracting Officer Office of Acquisitions

RFP Number : 75N95023R00007

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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

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. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. ESTIMATE OF EFFORT

f. COMMITMENT OF PUBLIC FUNDS

g. PROMOTING EFFICIENT SPENDING

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. PREPARATION COSTS

k. 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

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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. 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. Salary Rate Limitation

5. Total Compensation Plan

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION FACTORS

6. 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

The purpose of this contract is to provide the NIDA Division of Therapeutics and Medical Consequences with reports in which the Contractor assesses the pharmacological specificity and potential toxicity of lead compounds by screening at a large number of biological targets. This contract will also support studies to determine the affinity (IC50, Ki) and/or function (EC50, IC50) of test compounds for receptors at specified biological targets indicated by compound profiling or other sources. This contract will provide a way to screen additional compounds, possibly large compound libraries, at one or more receptors or transporters in order to determine biological activity, with the objective of discovering specific receptor or transporter ligands with novel chemical structures. This contract will provide assays to assess predictive toxicology in key areas that could indicate a candidate compound would have difficulties in the drug development process. This contract will allow development of in vitro assays at targets that may be of importance in the development of compounds for the treatment of drug abuse and its consequences. This contract will allow for the purchase of test compounds on an "as needed" basis.

ARTICLE B.2. PRICES/COSTS

a. This is a Single Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,000 (minimum) nor more than a total of $5,000,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract. Total compensation will be based on the value of the combined negotiated task orders.

b. The prices set forth in this ARTICLE will cover the contract ordering period of September 21, 2023 through September 20, 2028.

c. The Government will compete and award fixed price or cost re-imbursement Task Orders based on the work described in SECTION C of this contract and the costs/prices described in the Pricing Table for Tasks 1-7.

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

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

- 6 -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. To ensure that the Contractor is aware of the criticality of beginning contract close out process immediately following contract expiration, the Contractor shall include an Advance Understandings provision identifying the requirement to submit certain close out documents at the time of delivery of the final report under the contract, and is advised that quick close out procedures in accordance with FAR 42.7 shall be used by the Government to the maximum extent possible to expedite the administrative close of the contract or task order.

[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 November 21, 2022, 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.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: 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.

1) Receptor Profiling Screening Report

For each compound evaluated under Task 1, a separate and complete report shall be provided that contains assay methods for each receptor target and results, in tabular form, of the mean percent inhibition of binding obtained at the compound concentrations that were tested, with associated measures of variability (range or S.E.M.), as appropriate. At the beginning of each report, a summary paragraph shall be included in which the results of all assays are summarized with a brief discussion of the binding profile of the compound and recommendations for follow-up assays. The form and content of these reports shall be subject to the approval of the NIDA COR. The Contractor shall ensure that all reports are free from data, spelling, typographical, or grammatical errors. Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. The NIDA COR may require the Contractor to submit data spreadsheets in Microsoft Excel format and final reports in pdf format through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

2) Compound Library Screening Report

For groups of compounds evaluated under Task 4, the Contractor shall prepare reports with detailed assay methods and results in tabular form, with the mean percent inhibition and standard deviation or other appropriate measure of variability. At the beginning of each report, a summary paragraph shall be included in which the results of all assays are summarized with a brief discussion of the most potent compounds. The form and content of these reports shall be subject to the approval of the NIDA COR. The Contractor shall ensure that all reports are free from data, spelling, typographical, or grammatical errors. Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. The NIDA COR may require the Contractor to submit data spreadsheets in Microsoft Excel format and final reports in pdf format through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

3) Receptor Binding and/or Functional Activity Report

For each compound evaluated under Task 2, a separate and complete report of binding and/or functional activity shall be prepared. At the beginning of each report, a summary paragraph shall be included in which the results of receptor binding and/or functional activity https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

- 8 -are summarized. This report shall include detailed assay methods, inhibition and/or stimulation curves, and in tabular form, statistics appropriate to the assay conducted which may include IC50, EC50, Ki, Hill coefficient and associated measures of variability (range or S.E.M.), as appropriate. The form and content of these reports shall be subject to the approval of the NIDA COR. The Contractor shall ensure that all reports are free from data, spelling, typographical, or grammatical errors. Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. The NIDA COR may require the Contractor to submit data spreadsheets in Microsoft Excel format and final reports in pdf format through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

4) Predictive Toxicology Report

The results of predictive toxicology testing shall be prepared from results of assays done under Tasks 1, 2, and/or 3. These may include results from the profile battery, CYP450 testing, CiPA profile testing, mutagenicity testing, and possibly other tests. The form and content of these reports shall be subject to the approval of the NIDA COR. The Contractor shall ensure that all reports are free from data, spelling, typographical, or grammatical errors. Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. The NIDA COR may require the Contractor to submit data spreadsheets in Microsoft Excel format and final reports in pdf format through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

5) Assay Development Report

The report shall contain the protocol for performance of the assay including complete descriptions of all materials and methods.

Validation data shall be included. The form and content of these reports shall be subject to the approval of the NIDA COR. The Contractor shall ensure that all reports are free from data, spelling, typographical, or grammatical errors. Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. The NIDA COR may require the Contractor to submit data spreadsheets in Microsoft Excel format and final reports in pdf format through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA

COR.

6) Annual Reports

The Contractor shall provide a brief annual report. This report shall contain a brief description of the work performed and any problems that were encountered. The form and content of these reports is subject to the approval of the NIDA COR. Unless otherwise requested by the NIDA COR, this report shall not contain any data generated on test compounds. An electronic copy of this report shall go to the NIDA COR within 15 days of the end of the contract Years 1-4. The NIDA COR may require the Contractor to submit Annual Reports through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

7) Final Report

A final report will be required on or before contract expiration. This report shall incorporate the last annual report. An electronic copy of this report shall go to the NIDA COR and Contracting Officer on or before contract expiration. The NIDA COR may require the Contractor to submit the Final Report through the NIDA Livelink system (or other electronic system as designated by the NIDA COR). Reports may not be sent via e-mail unless specifically requested by the NIDA COR.

8. 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. 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,

- 9 -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.)

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 Section Contracts Management Branch Red Office of Acquistions, NIDA National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave, Room Bethesda, MD 20892-

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.

[Remainder of Page Intentionally Left Blank] https://www.ecfr.gov/current/title-45/part-94 http://www.iedison.gov

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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), whose position is described in Section G, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse Division of Therapeutics and Medical Consequences C/O NIH Mail Center

3WFN MSC 6016

16071 Industrial Drive ? Dock 11 Gaithersburg, MD 20892

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The ordering period of this contract shall be from September 21, 2023 through September 20, 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 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) Receptor Profiling Screening Report & Data 1 per compound COR via email – within 30 days of completion of assays

(2) Compound Library Screening Report 1 per library COR via email – within 30 days of completion of assays

(3) Receptor Binding Affinity and/or Function Report & Data 1 per compound COR via email – within 30 days of completion of assays

(4) Predictive Toxicology Report 1 per compound COR via email – within 30 days of completion of assays

(5) Assay Development Report 1 COR via email – within 30 days of completion of validation of assay

(6) Annual Report 1 (Years 1 – 4) COR via email – within 15 days following the end of each contract year

(7) Final Report 1 COR and CO via email

(8) Summary of Salient Results 1 COR via email – on or before contract expiration

(9) Final Invention Statement 1 COR and CO via email – on the expiration date of contract

(10) Annual Utilization Report 1 (Years 1 – 4) COR – within 15 days following the end of each contract year

(11) Financial Conflict of Interest (FCOI) 1 COR and CO – prior to the expenditure of any funds

(12) Indirect Cost Rate Proposals for all years (in which a proposal was not previously submitted) 1 CO – on the expiration date of contract

(13) Final Property Inventory (excluding intellectual property) and Standard Forms 1428 and 1429 (if applicable)

1 CO – on the expiration date of contract

(14) Subcontracting Compliance Reports for all years (if applicable) 1 https://www.esrs.gov

(15) Final Patent and Royalty Report 1 CO – on the expiration date of contract

(16) Contractor Release of Claims (Closing Statement) 1 CO – on the expiration date of contract

(17) Assignment of Refunds, Rebates and Credits 1 CO – on the expiration date of contract

(18) Final Invoice 1 CO – on the expiration date of contract

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

Addressee Deliverable Item No matthew.seager@nih.gov 1 – 11 tracy.cain@nih.gov 7, 9, 11 -13, 15 – 18

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.

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

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FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is not applicable to this contract.

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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:

Matthew Seager, Ph.D.

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

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

The Government may unilaterally change its COR designation.

ARTICLE G.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

To Be Named

ARTICLE G.3. TASK ORDER PROCEDURE

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

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

c. Evaluation and Award of Task Order Proposals

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

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price However, each TORFP will specify how the award decision will be made. The Government may conduct discussions prior to awarding a Task Order or award a Task Order without discussions. The Government reserves the right to cancel a TORFP any time prior to Task Order Award.

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

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

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below. The Contractor https://www.ipp.gov

- 16 -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- Tracy Cain Email Address- tracy.cain@nih.gov

Contracting Officer Representative

Name- Matthew Seager Email Address- matthew.seager@nih.gov

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.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

Name- Tracy Cain Email Address- tracy.cain@nih.gov

Contracting Officer Representative

Name- Matthew Seager Email Address- matthew.seager@nih.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 https://ofm.od.nih.gov/Pages/Customer-Service.aspx 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

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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 National Institute on Drug Abuse .

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:

Receptor Binding and Predictive Toxicology

g. Contract Line Items as follows:

Line Item # Line Item Description

1 Task Order No. 1 (for example)

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.

mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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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.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.

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

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