RFP-75N95022R00058.pdf

OMB #0990-0115

NATIONAL INSTITUTE ON DRUG ABUSE

REQUEST FOR PROPOSAL (RFP) No. 75N95022R00058

“Production of Cannabis and Related Materials for Research”

Issued by:

Joshua T. Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

Point of Contact: Shaun Rostad, Contract Specialist E-Mail: shaun.rostad@nih.gov Phone: 301.594.9516

DATE ISSUED:

PROPOSAL DUE:

September 14th, 2022

October 28th, 2022, 3:00 P.M. (Eastern Time)

The National Institute on Drug Abuse (NIDA) invites you to submit a proposal responding to the requirements of this RFP No. 75N95022R00058 for the “Production of Cannabis and Related Materials for Research”.

This Request for Proposal is released under FULL AND OPEN Competition Procedures.

Please refer to Section M for mandatory criteria. 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 52.204-13 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.

In accordance with the Controlled Substances Act of 1970, all offerors must possess, at the time of proposal submission, the Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and non-active constituents. Please refer to the following link: https://www.deadiversion.usdoj.gov/drugreg/marihuana.htm

This contract will facilitate NIDA’s role in supplying marijuana for research purposes through the Drug Supply Program (DSP). NIDA administers contracts with DEA licensed growers to provide quality marijuana, marijuana extracts, marijuana resin and marijuana preparations to NIH-funded researchers and to non-NIH funded researchers requesting materials from the DSP who possess a Schedule I research registration from DEA.

This contract facilitates the parties’ collaborative activities supporting the cultivation and distribution of marijuana for research purposes pursuant to regulatory revisions to 21 C.F.R. Part 1318 published as a final rule in the Federal Register at 85 FR 82333 and effective January 19, 2021; and (ii) maintains DEA’s responsibility to register bulk manufacturers of marijuana (i.e. growers) in a manner consistent with the public interest as enumerated in 21 U.S.C.

§ 823(a) and with the treaty obligations of the United States under the Single Convention on Narcotic Drugs, 1961 (Single Convention) (18 U.S.T. 1407).

NIDA prepared this Request for Proposal 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, and III of the Uniform Contract Format.

NIDA anticipates that a multiple award indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for an ordering period of five (5) years. However, the Government reserves the right to make a single award, multiple awards, or no award at all to the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet NIDA's requirements. NIDA intends to award cost reimbursement task orders under this contract. These individual task orders may include options periods and/or options quantities. If options or option quantities are utilized for an individual task order they will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. All funding will be made through the issuance of task orders and will be dependent on program needs and availability of funds.

The contract will contain a guaranteed minimum of $1,000 and an estimated maximum quantity of $25,000,000 for the ordering period. NIDA anticipates that the ordering period of the contract will be from March 23, 2023 through March 22, 2028.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L. Please include separate pricing for each individual sample task order and option quantity.

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 to the below address on or before 3:00 p.m. on Wednesday, September 28th, 2022. 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. Friday, September 30th, 2022. RFIs may be submitted by e-mail to shaun.rostad@nih.gov with the subject line “RFI – RFP 75N95022R00058.”

The Technical Proposal

Offerors shall complete and attach the “Technical Proposal Cover Sheet” for each copy of their technical proposal.

It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. NIDA will use this information to ensure that no conflicts of interest exist with the selected review committee members.

Technical Proposal are detailed in Section L.2.b.

The Business Proposal

Offerors must have an authorized organizational official sign the Business Proposal. It must contain a detailed breakdown of costs for each of the sample task orders and option quantities. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. NIDA directs special attention to Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 9. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 7) 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. 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.

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

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https:// ecps.nih.gov) no later than October 28th, 2022, 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 submitting a proposal via eCPS can be found in Attachment 1.

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

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).

NIDA 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 Shaun Rostad, or the undersigned, at the NIDA Section, Contracts Management Branch Red. We may be reached at (301) 594.9516; collect calls will not be accepted or mjcontract@mail.nih.gov. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Sincerely, Joshua T. Lazarus, Contracting Officer National Institutes of Health, Office of Acquisition, NIDA

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:75N95022R00058

3. Issue Date: September 14, 2022

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Production of Cannabis and Related Materials for Research

6. ISSUED BY:

NIDA Section, Contracts Management Branch Red Office of Acquisitions, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, Maryland 20892

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 3:00 PM local time on October 28, 2022. Offers will be valid for 180 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, " Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission ( eCPS) Website." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the eCPS Website.

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) prior to proposal submission. Offerors must access the SAM through The System for Award Management at http://www.sam.gov.

11. FOR INFORMATION CALL: Shaun Rostad, Contract Specialist.

PHONE: (301) 594-9516

e-MAIL: shaun.rostad@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Joshua T. Lazarus Contracting Officer Office of Acquisitions, NIDA http://www.sam.gov

RFP Number : 75N95022R00058

- 2 -

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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. 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. Selection of Offerors

- 3 -

10. Institutional Responsibility Regarding Investigator Conflicts of Interest

11. ROTC Access and Federal Military Recruiting on Campus

12. Certification of Filing and Payment of Taxes

13. Past Performance Information

14. Information and Physical Access Security

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. TECHNICAL EVALUATION FACTORS

5. PAST PERFORMANCE FACTOR

- 4 -

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 (AS NECESSARY) AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

In brief, the main objectives of this contract are to:

(1) cultivate and harvest cannabis (marijuana) for the NIDA Drug Supply Program (NDSP);

(2) extract cannabis to produce pure and standardized (current Good Manufacturing Practices (cGMP)-grade) cannabis extracts containing varying concentrations of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and other constituents (e.g., other cannabinoids and/or other plant components) as directed by the COR;

(3) isolate cGMP and research grade THC, CBD, and other cannabinoids (≥98% purity) as directed by the COR;

(4) analyze cannabis, cannabis extracts, and/or other cannabis products (i.e. isolated cannabinoids, etc.) for authenticity, purity and stability, and provide certificates of analysis for products and as directed by the COR;

(5) maintain Chemistry Manufacturing and Controls information to support the use of the cannabis, provided under this task, under an Investigational New Drug (IND) application to FDA. This can also be accomplished through the establishment and maintenance of a Drug Master File (DMF) filed with FDA.

(6) Provide the CMC information or a Letter of Authorization (LOA) for FDA to reference the Drug Master File (DMF), to researchers using the cannabis under an IND as identified by the COR.

(7) supply cannabis, cannabis extract and/or other cannabis products to the NIDA Drug Supply program upon COR authorization.

In accordance with the Controlled Substances Act of 1970, any offerors must possess, at the time of solicitation, the Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and non-active constituents. Please refer to the following link: https:// www.deadiversion.usdoj.gov/drugreg/marihuana.htm

This contract will facilitate NIDA's role in supplying marijuana for research purposes through the Drug Supply Program (DSP). NIDA administers contracts with DEA licensed growers to provide quality marijuana, marijuana extracts, marijuana resin and marijuana preparations to NIH-funded researchers and to non-NIH funded researchers requesting materials from the DSP who possess a Schedule I research registration from DEA.

This contract facilitates the parties' collaborative activities supporting the cultivation and distribution of marijuana for research purposes pursuant to regulatory revisions to 21 C.F.R. Part 1318 published as a final rule in the Federal Register at 85 FR 82333 and effective January 19, 2021; and (ii) maintains DEA's responsibility to register bulk manufacturers of marijuana (i.e. growers) in a manner consistent with the public interest as enumerated in 21 U.S.C.

- 5 -

S 823(a) and with the treaty obligations of the United States under the Single Convention on Narcotic Drugs, 1961 (Single Convention) (18 U.S.T. 1407).

ARTICLE B.2. PRICES/COSTS

a. NIDA anticipates a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,000 (minimum) nor more than a total of $25,000,000 (maximum combined amount for all contractor holders) for successful performance of this contract. The minimum is expected to be inclusive of the first awarded Task Order.

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.

c. This IDIQ contract has a total ordering period of five years from March 23, 2023 through March 22, 2028.

As necessary, NIDA will issue Task Orders for the Contractor to perform any or all of the Tasks listed in the Statement of Work (SOW).

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

e. Ordering procedures are described in The METHOD OF ORDERING 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 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. NIDA reserves the right to have the contracted services in this contract benefit NIDA and other components of NIH.

NIDA’s mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. As a steward of Federal funds intended to promote the public health, NIDA must ensure the integrity of the science it supports and avoid both actual and perceived conflicts of interest. Therefore to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research to be performed under NIH contracts will be biased by any Investigator financial conflicts of interest. The Institution shall comply with all requirements of 45 CFR Part 94 at:

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94.

[The remainder of this page is intentionally left blank.] https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94

- 6 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format as required in Article F.2.

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: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. 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 electronic reports will be required as follows and as directed in ARTICLE F.2:

1. Monthly Reports: This report shall present a description of all activities during the month, any problem encountered and problem solved, activities planned for the ensuing period, a list of current inventory of cannabis and cannabis products produced and their supply as authorized by the COR, and any other relevant communication with the COR. The Contractor shall submit one electronic copy of the report to the COR within 5 calendar days after the end of each month. A monthly report shall not be required when either a semi-annual, annual, or the final report is due.

2. Semi-Annual Reports: This report shall present a summation of previously submitted monthly reports within the previous six months of performance. The Contractor shall submit one electronic copy of the report to the COR within 15 calendar days after the end of each reporting period. A semi-annual report shall not be required when either an annual or the final report is due.

3. Annual Report(s): This report shall present a summation of activities during the entire year. The Contractor shall submit one electronic copy of the report to the COR and one electronic copy to the CO within 15 calendar days after the end of each reporting period. An annual report shall not be required when the final report is due.

4. Final Report: This report shall include a summation of work performed and the results obtained during the entire contract period. The report shall be comprehensive and describe results achieved in detail. A monthly, semi-annual, or annual report shall not be required when the final report is due.

The Contractor shall submit one electronic copy to the COR and one electronic copy to the CO upon contract expiration.

5. Specific Task Reports: The Contractor shall submit specific task reports as directed by the COR.

http://www.hhs.gov/web/508/index.html

- 7 -

2. 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, 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.)

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

A. Baseline Security Requirements

a. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/NIH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

■ Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

■ Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

■ Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of HHS/NIH and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories . Based on information provided by the ISSO, CISO, OpDiv SOP, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

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://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

- 8 -

■ Confidentiality: [ ] Low [ ] Moderate [ ] High

■ Integrity: [ ] Low [ ] Moderate [ ] High

■ Availability: [ ] Low [ ] Moderate [ ] High

■ Overall Risk Level: [ ] Low [ ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/NIH regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/NIH Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/NIH security and/or privacy officials.

b. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information must be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

i. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

iii. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

c. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the OpDiv non-disclosure agreement, https://ocio.nih.gov/aboutus/publicinfosecurity/ acquisition/Documents/Nondisclosure.pdf , as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

d. Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor- The Contractor (and/or any subcontractor) shall ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of HHS are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

i. Encrypt equipment and sensitive information stored and/or processed by such equipment in accordance with HHS and FIPS 140-3 encryption standards.

- 9 -

ii. Configure laptops and desktops in accordance with the latest applicable United States Government Configuration Baseline (USGCB), and HHS Minimum Security Configuration Standards;

iii. Maintain the latest operating system patch release and anti-virus software definitions within 15 days.

iv. Validate the configuration settings after hardware and software installation, operation, maintenance, update, and patching and ensure changes in hardware and software do not alter the approved configuration settings; and

v. Automate configuration settings and configuration management in accordance with HHS security policies, including but not limited to:

■ Configuring its systems to allow for periodic HHS vulnerability and security configuration assessment scanning; and

■ Using Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner capabilities to scan its systems at least on a monthly basis and report the results of these scans to the CO and/or COR, Project Officer, and any other applicable designated POC.

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 first annual utilization report shall be due on or before March 15, 2024. Thereafter, reports shall be due annually on the contract anniversary date (if Option Period(s) are exercised). 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 submitted to the Contracting Officer.

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 encouraged 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.iedison.gov

- 10 -

SECTION D - PACKAGING, MARKING AND SHIPPING

1. 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.

2. All items shall be preserved, packaged, and marked to meet the requirements for controlled substances per the requirements of the Drug Enforcement Admininistration (DEA) and the packing requirements of the carrier, including that which may be necessary to prevent deterioration and damages to items due to the hazards of weather, shipping, handling, and storing. The Contractor shall pack marijuana cigarettes with approximately 300 per canister. Labeling shall be suitable to meet Food and Drug Administration (FDA) requirements and shall follow the instructions from the Code of Federal Regulations (CFR) regarding such substances. Labeling shall be adequate to meet the requirements to support an Investigational New Drug (IND). The quantity shall be determined after a recipient's request has been received. The labeling shall conform to FDA and CFR requirements and be adequate to meet the requirements to support an IND.

- 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, the Contracting Officer's Representative (COR), as specified in Section G, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse National Institutes of Health

3WFN MCS 6016

301 North Stonestreet Ave

Bethesda, MD 20892

*For delivery service or hand delivery, use Rockville, MD 20850

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

- 12 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. OREDERING PERIOD

a. The ordering period for this contract shall be from March 23, 2023 through March 22, 2028. The period of performance for each task order shall be specified in the respective task order.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer (CO), 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 required to be delivered electronically in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

(1) Monthly Reports 1 electronic copy -

Contracting Officer's Representative (COR)

Within 5 calendar days after the end of each month.

(2) Semi-Annual Reports 1 electronic copy - COR Within 15 calendar days following the 6-month reporting period.

(3) Annual Reports 1 electronic copy - COR Within 15 calendar days following the 12-month reporting period.

(4) Final Report with Summary of Salient Results

1 electronic copy - COR On or before the expiration date of the contract.

(5) Reporting of Financial Conflict of Interest (FCOI)

1 electronic copy - CO Per Article C.2.(b)(1).

(6) Annual Utilization Reports 1 electronic copy - CO Annually on contract anniversary date.

(7) Final Invention Statement 1 electronic copy - CO On or before the expiration date of the contract.

(8) Non-Disclosure Agreements

1 electronic copy - COR Prior to performance of any work under the contract.

(9) Small Business Subcontracting Reports

1 electronic copy - CO, via Electronic Subcontracting Reporting System (eSRS).

By April 30th and October 30th 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. LEVEL OF EFFORT

a. During the ordering period of this contract, the Contractor shall provide direct labor Hours as specified in awarded Task Orders.

- 13 -

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished.

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

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

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: http://www.acquisition.gov/far .

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.

http://www.acquisition.gov/far

- 14 -

SECTION G - CONTRACT ADMINISTRATION DATA

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

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

[To be specified prior to award.]

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

The 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 ordering period; (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 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 calendar days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

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

Name Title

[To be determined.]

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.

- 15 -

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

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

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

Generally, the Contractor will be asked to demonstrate the following as appropriate:

● Understanding of the requirements;

● Experience and capability on similar tasks;

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

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

- 16 -

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

● Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

● References to evaluate past performance; and

● Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

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

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price . However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting…