D_RFP package.pdf

OMB #0990-0115

Request for Proposal (RFP) No. 75N95024R00058 “GMP Synthesis of Bulk Drug Substances”

Issued by:

Rob Bailey, Contracting Officer NIDA Section, Contracts Management Branch Office of Acquisition, NIDA C/O NIH Mail Center NIDA 3WFN MSC 6023– Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

Point of Contact: Polina Klimenkova, Contract Specialist E-Mail: polina.klimenkova@nih.gov Phone: 301.443.6677

DATE ISSUED: March 20, 2024

PROPOSAL DUE DATE: May 3, 2024 by 3:00 P.M. (EST)

The National Institute on Drug Abuse invites you to send a proposal responding to the requirements of this RFP No. 75N95024R00058 for “GMP Synthesis of Bulk Drug Substances.” This RFP is released under FULL AND OPEN Competition Procedures. The NAICS code applicable to this buy is 541715. See Section L.1.b. of this RFP.

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, III of the Uniform Contract Format.

NIDA anticipates awarding one (1) indefinite delivery, indefinite quantity task order contract with individually negotiated task orders over a five-year period of performance. NIDA expects to award completion or level of effort, cost reimbursement and fixed-price task orders. NIDA expects to award at least one task order to a single contractor at the time of contract award. Future funding will be made through issuance of task orders and will be dependent on program needs and funding availability.

Offerors should anticipate that the ordering period will be from November 2024 to November 2029.

The contract will contain a guaranteed minimum of $1,000 and not-to-exceed maximum of $10,000,000 over the full five-year ordering period. You should respond with technical and pricing proposals based on the assumptions provided in Section C and L of the RFP. Note: You must include all of the tasks (1 – 7) listed in the Statement of Work (SOW) in your technical proposal.

Please refer to Section M for mandatory qualification criteria. Additionally, all offerors must be REGISTERED and have an ACTIVE System for Award Management http://www.sam.gov/ (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management http://www.sam.gov/(www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance and FAR 52.207- 7 mailto:polina.klimenkova@nih.gov

System for Award Management to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

General

We direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Your attention is further directed to Attachment 2, “Proposal Intent Response Sheet.” Please complete this form and return it to this office on or before April 10, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which we will make a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. However, you are not to fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data.

The Government will complete those parts prior to contract award and (if negotiations are conducted) will tailor those items through final negotiations.

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. You must submit your questions in sufficient time for receipt on or before April 10, 2024. RFIs may be submitted by e-mail to polina.klimenkova@nih.gov with the subject line “RFI –

RFP 75N95024R00058.

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) before 3:00 p.m., Eastern Standard Time (EST) on May 3, 2024. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Following your proposal submission and our review, the Contracting Officer may seek more information.

In accordance with FAR 15.306(a) (3) and FAR 52.215-1, we advise you that the Government intends to evaluate proposals and award a contract without discussions (except clarifications). Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. However, we reserve the right to conduct discussions if the Contracting Officer later decides them to be necessary. The Contracting Officer reserves the right to make no award at all to the RFP. In addition, the RFP may be amended or cancelled as necessary to meet requirements.

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

Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Format and content requirements of your Technical Proposal are detailed in Section L.2.b. Technical Proposal. Also, you must complete the “Technical Proposal Cover Sheet” and use it as the cover sheet for each copy of your technical proposal. It is important that you list all professional personnel and organizations named in http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm the proposal who have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named.

You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet.

We will use this information to ensure that no conflicts of interest exist with the selected review committee members.

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

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

All notices related to this solicitation will be posted on Sam.gov (https://www.sam.gov).

If you would like to receive e-mail notifications of updates to this solicitation, please register with SAM.gov.

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

You should direct all requests for any information concerning this RFP to Polina Klimenkova, NIDA Section, Contracts Management Branch who may be reached by e-mail at polina.klimenkova@nih.gov.

Discussions with any other individual outside the NIDA Contracts Management Branch should not occur.

Sincerely, Rob Bailey, Contracting Officer NIDA Contracts Management Branch Office of Acquisitions, NIDA/NIH

Enclosure mailto:polina.klimenkova@nih.gov

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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:

75N95024R00058

3. Issue Date:

March 20, 2024

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title: GMP Synthesis of Bulk Drug Substances

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 Proposal (eCPS)," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 p.m. local time on May 3, 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: Polina Klimenkova, Contract Specialist

PHONE: (301) 443-6677

e-MAIL: polina.klimenkova@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Rob Bailey /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 ... 74

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……………………………………………………………………………….94

7. PAST PERFORMANCE FACTOR

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Solicitation No.75N95024R00058 NIDA Reference No. N01DA-24-8915

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

One of the primary objectives of the National Institute on Drug Abuse (NIDA) is to develop safe and effective medications for treating cocaine, methamphetamine and opiate dependence. NIDA established the medications development program to support, through grants and contracts, every step of the medication’s development process: chemical discovery and syntheses; screening; dosage formulation; biochemical, pharmacological, and toxicological testing; and clinical trials to determine safety and efficacy. The purpose for this contract will be to provide a resource for the synthesis of bulk drug substances for use in preclinical toxicity studies as well as clinical safety and efficacy trials.

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 a total of $1,000 (minimum) nor more than a total of $10,000,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract.

b. For cost reimbursement Task Orders, the fixed fee for individual task orders will be negotiated by task order. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, subject to the withholding provisions and of this contract.

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

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c. The costs set forth in this ARTICLE will cover the contract ordering period November 2024 through November 2029.

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

(See ARTICLE G.3 for Task Order Procedures).

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

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 II 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."

a. Technical Progress Reports

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

1. Reporting Format/Procedures

The Contractor shall prepare and submit the following reports in electronic copies in Microsoft Windows compatible personal computer files using Microsoft Word for text and numerical data following the formats described below:

Front cover to contain: Date, title, study report name, drug substance/formulation identification, agency (NIDA), division (DTMC) and NIDA COR name/address/phone number, contract number (TBD), Contractor name and investigator names.

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

Appendices to contain: All approved (with signatures) methods of analyses, product specifications, and protocols for testing, sampling, and stability study. All appropriate references and batch records.

2. Types of Technical Progress Reports

For proposal preparation purposes only, it is estimated that electronic version(s) will be required as follows:

a) Weekly Progress Reports:

The Contractor shall provide weekly progress reports during the period of active Task Orders. Weekly progress reports shall include descriptive information about the activities undertaken during the reporting period (including any problems encountered so that solutions can be discussed) and activities planned for future reporting periods. Weekly progress reports shall also include a description of synthetic 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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b) Annual Progress Reports:

For any contract year where active Task Orders were performed, the Contractor shall provide annual reports, which shall contain a detailed description of work performed, problems encountered and anticipated, and solutions during the reporting period. Annual reports shall incorporate all salient activities performed during each contract year. The Contractor shall submit the electronic copies of this report to the COR and to the CO within 30 calendar days following each 12-month reporting period. An annual report shall not be required when the final report is due.

c) Final Report:

The Contractor shall provide a final report, which shall contain a summary of drug substances produced during the entire contract period, and a description of analytical results. The report shall also discuss any problems encountered and the successful resolution of those problems. The Contractor shall submit one electronic copy of this report to the COR and to the CO on or before the expiration date of the contract. A weekly or annual report shall not be required when the final report is due.

d) Individual Subcontracting Report:

Subcontracting report for individual contracts: This report is to be submitted semiannually as well as at contract completion.

e) Task Order Reports:

The Contractor shall submit technical reports for each Task Order issued, per the delivery and distribution instructions below.

I. Task Report: The Contractor shall submit this report for each batch of GMP or non- GMP material manufactured. It must be acceptable in format and substance for adaptation into a Chemistry, Manufacturing, and Control (CMC) section for each drug substance for submission to the FDA in support of IND and NDA applications. At the direction of the COR, the Contractor shall include all analytical data of the final product as well as all intermediates in this report. The Contractor shall submit one electronic copy of this report to the COR and to the CO within 15 working days after the COR approves the Certificate of Analysis (CoA).

II. Certificates of Analysis (CoAs): The Contractor shall submit CoAs for both the drug substance and reference standard upon completion of the quality control test for each batch of the chemical material prepared. The Contractor shall submit one electronic copy of the CoA to the COR within 5 working days of completion of the quality control tests. The CoA must be approved by the COR before the Contractor ships the material.

3. 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. Synthetic Material

The Contractor shall submit the synthetic material, including reference standard, produced as required by the Task Order to a site designated by the COR. The COR will determine the acceptability of the material based on an independent analysis and review of the CoA provided by the Contractor.

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The COR will determine and communicate acceptability to the Contractor within 2 weeks of receipt of the independent analysis.

2. Service Contract Annual Report

In accordance with FAR 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) referenced in Article I.3 of this contract, the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) the following information to http://www.sam.gov, with an electronic copy to the Contracting Officer:

(1) Contract number and order number.

(2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the order.

(3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

(4) Data reported by subcontractors under paragraph (f) of this clause.

3. 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.)

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

Please refer to Article F.2 and Article H.101 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 on 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 at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94

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"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/

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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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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).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The estimated ordering periodof this contract shall be from November 2024 through November 2029.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer (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) Weekly Progress Reports 1 Electronic Copy - Contracting Officer's Representative (COR)

To be determined in each Task Order.

(2) Annual Progress Reports 1 Electronic Copy – COR and CO

Within 30 calendar days following each 12-month reporting period.

(3) Final Report with Summary of Salient Results

1 Electronic Copy – COR and CO On or before the expiration date of the contract.

(4) Task Report 1 Electronic Copy – COR and CO Within 15 working days after the COR approves the Certificate of Analysis (CoA).

(5) Certificates of Analysis (CoAs)

1 Electronic Copy - COR

Within 5 working days of completion of the quality control tests.

(6) Synthetic Material To be determined in each Task Order - site to be designated by the COR.

Shipped within 2 weeks of receipt of independent analysis.

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

1 Electronic Copy - CO Per Article C.2.(b)(3).

(8) Annual Utilization Reports 1 Electronic Copy - CO

Annually on contract anniversary date.

(90) 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 C.2.b.4 for details

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

Semi-Annually on April 30th and October 30th

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

Annually on October 30th

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(13) Vulnerability Management Plan

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

Within 90 calendar days after contract award

(14) Incident and Breach Response Plan (IRP)

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

Within 90 calendar days after contract award

(15) Security Assessment Plan (SAP) & Security Assessment Report (SAR)

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

Within 90 calendar days after contract award

(16) FIPS 199 Assessment 1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

Within 90 calendar days after contract award

(17) Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

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

Within 90 calendar days after contract award

(18) E-Authentication Threshold Analysis (ETA) / E-Authentication Risk Assessment (ERA)

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

Within 90 calendar days after contract award

b. The above items shall be addressed and delivered electronically to:

Addressee Deliverable Item No Quantity Contracting Officer

2, 3, 4, 8, 9, 10, 11, 14, 15, 16 and 17 1

Contracting Officer’s Representative

1, 2, 3, 4, 5, 6, 7, 11, 14, 15, 16 and 17 1

Information System Security Officer (ISSO)

13,14, 15, 16, 17 and 18 1

c. In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items: Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property); standard forms 1428 and 1429 (if applicable);

settling all subcontract costs and any issues thereunder; subcontracting compliance reports for all years to the eSRS;

final patent and royalty reports; Contractor's release of claims, i.e. Contractor's closing statement; the Contractor's Assignment of Refunds, Rebates and Credits; and a final invoice or completion voucher (marked final).

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (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, Red.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and https://www.ipp.gov/ mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

- 17 -replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request.

The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: GMP Synthesis of Bulk Drug Substances.

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 (Nov 2021)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

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

(End of Clause)

ARTICLE G.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

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.

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

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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…