Solicitation_75N95024R00003_F.pdf

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National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95024R00003

"Preparation and Distribution of Research Drug Products"

Issued by:

Josh Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Green Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892 Point of Contact: Scott Duernberger, Contract Specialist E-Mail: scott.duernberger@nih.gov Phone: (301) 594-0670

DATE ISSUED: Tuesday, October 1, 2024

PROPOSAL DUE DATE: Friday, November 15, 2024, 1:00 P.M. Eastern Time

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00003 titled "Preparation and Distribution of Research Drug Products".

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 offerers 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 offerers who do not meet the SAM requirement.

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, 11, Ill of the Uniform Contract Format.

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded with a contract ordering period of five (5) years. NIDA may award either cost reimbursement and/or fixed price task orders under this contract.

These individual task orders may include options and/or options quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds

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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:

75N95024R00003

3. Issue Date:

10/1/2024

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title: Preparation and Distribution of Research Drug Products

6. ISSUED BY:

NIDA Section, Contracts Management 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:

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 1:00 p.m. local time on

November 15, 2024. Offers will be valid for 210 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." Proposals

Submitted by any other means such as facsimile, hard copy or e-mail will not be accepted.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE

PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE

CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal and continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/

11. FOR INFORMATION CALL: Scott Duernberger, Contract Specialist

PHONE: (301) 594-0671

E-MAIL: scott.duernberger@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Josh Lazarus / Contracting Officer

NIDA Contracts Management Branch

Office of Acquisitions, NIDA/NIH

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

a. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

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. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Certification Regarding Tax Matters, FAR 52.209-12 (Oct 2020)

13. Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation

14. Past Performance Information

15. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT PROCUREMENTS ... 78

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Enhancing Reproducibility through Rigor and Transparency

5. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor-Protégé Program, HHSAR 352.219-70 (December) 2015

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES

5. EVALUATION OF DATA MANAGEMENT AND SHARING PLAN OR ANY EXCEPTIONS

6. TECHNICAL EVALUATION FACTORS……………………………………………………………………………….98

7. PAST PERFORMANCE FACTOR

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Solicitation No. 75N95024R00003 NIDA Reference No. N01DA-25-8952

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

The NIDA Drug Supply Program plays a major role in promoting drug abuse and drug addiction research by providing to the drug abuse research community with a wide variety of authentic controlled and uncontrolled drug compounds, some of their dosage forms, and marijuana and nicotine research cigarettes for research. Through this contract NIDA plans to continue to acquire drug compounds, drug dosage forms for the NIDA drug supply inventory, to have capability to import drug compounds from international sources, to develop and prepare drug dosage forms, to have capability to manufacture marijuana and nicotine research cigarettes, to frequently analyze them for purity, and to store and distribute them for research upon NIDA authorization according to DEA regulations. Such dosage forms of controlled and uncontrolled drug compounds include morphine, methadone and naltrexone pellets of various strengths, their placebo counterparts, and various cannabinoid preparations (delta-8- and delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene) and other compounds of interest to the drug abuse research community.

Upon issuance of Task Orders, the Contractor shall acquire, analyze, store, and ship bulk drugs, other chemical compounds, and drug dosage forms to aid NIDA in promoting drug abuse and drug addiction research.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than the total for an initial contract kick-off meeting (minimum) nor more than a total of $19,975,000 (maximum) for successful performance of this contract.

b. For cost reimbursement Task Orders, the fixed fee for individual Task Orders will be negotiated by

Task Order. For completion task orders, the fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. For level-of-effort term form task orders, the fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1 of this contract. Payment of fixed fee shall not be made in less than monthly increments.

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c. Pursuant to FAR Clause 52.217- 7, Option for Increased Quantity- Separately Priced Line Item and

FAR Clause 52.217-9, Option to Extend the Term of the Contract Priced Line Item, set forth in

ARTICLE I.3. and ARTICLE I.4. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option specified in the Task Order Statement of

Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given 15 calendar days before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in

SECTION H of this contract. The price of the task order will be increased as negotiated and set forth in the individual task Orders.

d. The costs set forth in this ARTICLE will cover the estimated ordering period March 20, 2025 through

March 19, 2030.

e. The Government anticipates issuing cost reimbursement or fixed price task orders based on the work described in SECTION C of this contract.

f. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this

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. ADVANCED UNDERSTANDINGS

DEA Registration

For the duration of the contract, the Contractor agrees to maintain, at no direct cost to this contract, the required DEA Research and Manufacturing Registrations for Schedules I to V controlled substances for working with scheduled drugs.

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 benefit NIDA and any other component of NIH.

[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, 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 specified in Section F.

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."

The Contractor shall prepare and submit the following reports using the format below:

• Front cover to contain: date, title, study report name, task order number, agency (NIDA), division (DTMC) and NIDA Contracting Officer's Representative (COR) name/address/phone number, contract number, Contractor name and investigator names.

• Main body to contain: Narrative summaries of the work accomplished and interpreted results, and conclusion. The Contractor shall ensure that all reports are free from spelling, typographical, or grammatical errors. Study Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction.

a. Technical Progress Reports

The Contractor shall submit progress reports covering the work accomplished during each reporting period.

1. Monthly Progress Reports: Within the first 5 business days after each calendar month, the

Contractor shall a report on activities during the preceding month. In the monthly report, the Contractor shall briefly (in one or two paragraphs) describe the work accomplished, including the number of samples received, assay completed, samples remaining, and expected date for completion, any changes in staff, and actual or projected problems and proposed solutions. Monthly reports are not required for any month where no active task orders are issued.

2. Semi-annual Report: This report shall include a summation of previously submitted monthly reports including any specific data and issues related with activities during that period. It shall be submitted to the NIDA COR no later than the 15th of the month electronically and in one hard copy by regular mail.

No monthly report will be needed when this report is due.

3. Annual Reports: Not later than 15 business days after the end of each year of contract work, the

Contractor shall provide a comprehensive report on activities during the year. The annual report for the last year of the contact shall be incorporated into the Final Report.

4. Final Report: On or before the expiration date of the contract, the Contractor shall provide a comprehensive summary of work conducted during the entire contract period including a summary of the clinical studies completed for each study medication. This report shall incorporate the final annual report, if an option to extend the contract term was exercised.

https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

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5. 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 CO in electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

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

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. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

3. HHS Security and Privacy language For Information and IT Procurements

Please refer to Article F.2 and Article H.12 for HHS Security and Privacy Language for Information and IT deliverables.

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 electronically on or before the expiration date of the contract 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.

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.

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

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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 Administration (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. 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 quantity of material to be shipped and shipping address will be provided by the COR.

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NIDA Reference No. N01DA-25-8952

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer (CO) 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), specified in Section G, is the authorized representative of the CO.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse

National Institutes of Health c/o

3WFN MSC 6012

301 N Stonestreet Ave

Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the CO 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 CO will make its full text available.

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

For Fixed-Price Task Orders Only:

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The estimated ordering period of this contract shall be from March 20, 2025 through March 19, 2030.

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 delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

(1) Monthly Progress Report 1 Electronic Copy – COR and CO

Within the first 5 business days after each calendar month.

(2) Semi-annual Report 1 Electronic Copy – COR and CO No later than the 15th calendar day following 6 months of performance.

(3) Annual Progress Report 1 Electronic Copy – COR and CO Within 15 business days of end of contract year.

(4) Final Report 1 Electronic Copy – COR and CO On or before the expiration date of the contract.

(5) Summary of Salient Results 1 Electronic Copy - COR and CO On or before the expiration date of the contract.

(6) Source Code and Object Code 1 lot to COR On or before the expiration date of the contract.

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

1 Electronic Copy - CO Per Article C.2.(b)(1).

(8) Annual Utilization Reports 1 Electronic Copy - CO

Annually on contract anniversary date.

(9) Final Invention Report 1 Electronic Copy - CO

On or before the expiration date of the contract.

(10) Contractor Non-Disclosure Agreements

1 Electronic Copy – COR and CO Prior to performance of any work under the contract. See article H.12 for details.

(11) Individual Subcontract Report 1 electronic copy submitted to eSRS (if applicable)

Semi-Annually on April 30th and October 30th

(12) Summary Subcontract Report 1 electronic copy submitted to eSRS (if applicable)

Annually on October 30th

(13) Signed Rules of Behavior for all employees

1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

Initiation of contract and at least annually thereafter. NIH Rules of Behavior found within the NIH Annual Information Security Training Course. If additional Rules of Behavior apply for NIDA, they will be provided.

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NIDA Reference No. N01DA-25-8952

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

ARTICLE F.3. LEVEL OF EFFORT

a. If an individual Level of Effort Task Order is awarded, then the Contractor shall have satisfied the requirement for that Task order if not less than 90% nor more than 120% of the total direct labor hours specified in each applicable task order. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

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

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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 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 352.242-70 (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 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.

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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 the Contractor 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. Ordering Process.

1. The Contractor 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. The Contractor will be provided an adequate time to prepare and submit responses based on the

Contracting Officer's consideration of the estimated dollar value and complexity of proposed Task Order.

Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

● Understanding of the requirements;

● Experience and capability on similar tasks;

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

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

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

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

● Cost/Price to perform the Task Order.

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d. Evaluation and Award of Task Order Proposals

The Contractor shall submit a Task Order proposal in response to the TORFP. Upon receipt of a Task Order proposal, the Government may conduct discussions prior to awarding a Task Order or may award a Task

Order without discussions.

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

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

TORFP will be used for evaluation of each proposal. Each TORFP will specify how the award decision will be made. Generally, technical factors will be more important than cost or price.

Upon completion of evaluations, the Contracting Officer will issue a Task Order to the Contractor. The

Government reserves the right to cancel a TORFP any time prior to award of the Task Order.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

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

Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform

(IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

The Contractor must submit a copy of the electronic invoice to the following Approving Official

(Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name - TBD Email Address - TBD

Contracting Officer Representative

Name - TBD Email Address - TBD

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

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

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Section, Contracts Management Branch, Green.

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 https://www.ipp.gov/ mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

- 18 -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: Analytical Services Center for Medications Development

g. Contract Line Items will be designated by Task Order.

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

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with

Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

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

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause

352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Mar 2023)

a. 1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after 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.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the 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.6. INDIRECT COST RATES

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

Director, Division of Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801

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BETHESDA MD 20892-7663

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

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS

Contracting Guide for Contract of Government Property," Appendix Q, which can be found at:

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Go vernment%20Property-Appendix%20Q.pdf

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with

FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually beginning in the first quarter of the Government's fiscal year following one full year of performance.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf http://www.cpars.gov/

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NIDA Reference No. N01DA-25-8952

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

• Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten (10) calendar days prior to disclosure.

• Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

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• Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

• Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any company/institution/individual not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate understand that they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. The Contractor shall ensure that Subcontractors who receive funds to carry out part of the Federal award understand they are also subject to subsection 301(d) of the Public Health Service Act and the NIH Policy for Issuing CoC.

ARTICLE H.3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1)

Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4)

Authentication of Key Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing

Reproducibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information.