Sol_75N95024R00077.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health National Institute on Drug Abuse Bethesda, Maryland 20892

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95024R00077

PROJECT TITLE: Drug Manufacturing and Formulation Program (DMFP)

ISSUED BY:

Marlene Milgram Contract Specialist NINDS Section Contracts Management Branch, Red Office of Acquisition, NIDA

Email: marlene.milgram@nih.gov Phone: (301) 594-0864

Rieka Plugge Contracting Officer, Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515

DATE ISSUED: June 7, 2024

PROPOSAL DUE: July 22, 2024, 4:00 P.M. Eastern Time

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00077 for services supporting the "Drug Manufacturing and Formulation Program (DMFP).

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

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

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

mailto:evan.feely@nih.gov mailto:rieka.plugge@nih.gov http://www.sam.gov/

NINDS anticipates that three to five Indefinite Delivery, Indefinite Quantity (IDIQ), task order type contracts will be awarded for an ordering period of performance of ten years. NINDS may award either level of effort or completion type cost reimbursement task orders under these contracts. These individual task orders may include option periods and/or option quantities. If option periods or option quantities are utilized for an individual task order, they will be clearly defined in the Task Order Request for Proposal (TORFP) and will be evaluated at the time of task order award. All funding will be made through the issuance of task orders and will be dependent on program needs and availability of funds. Various task orders will be issued to support distinct DMFP projects.

Each IDIQ contract will contain a guaranteed minimum award of $5,000. All DIQ contracts and all task orders combined will not exceed the estimated maximum of $49,999,999 for the 10-year ordering period. NINDS anticipates that the 10-year ordering period of performance will be January 15, 2025 through January 14, 2035.

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

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 2 is a Proposal Intent Response Form. Please complete this form and return it to the below address on or before 4:00 P.M. Eastern Time on June 26, 2024.

The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical and cost factors, as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Offeror Questions Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. Offeror questions must be submitted on or before 4:00 P.M. on June 21, 2024. Offeror questions may be submitted by e-mail to marlene.milgram@nih.gov with the subject line:

“RFI - RFP 75N95024R00077”

NOTE: Site visits will not be provided.

The Technical Proposal It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed. NINDS will use this information to ensure that no conflicts of interest exist with the selected review committee members. Technical Proposal Instructions are detailed in Section L.2.b.

mailto:evan.feely@nih.gov

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal. It must contain a detailed breakdown of costs for each of the sample task orders and option quantities.

For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. NINDS directs special attention to Attachment 9, Breakdown of Proposed Costs (plus fixed fee). Business Proposals should include a breakdown of proposed costs using the format of Attachment 9. And be submitted as a searchable PDF as part of an Offeror’s Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, Proposal Summary and Data Record (see Attachment 8) of both the Principal Investigator and the Offeror's authorized business representative on the form.

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

In addition, Offerors are advised that a “Determination of Exceptional Circumstances” (DEC) to incorporate HHSAR clauses 352.227-11 and HHSAR 352.227-14 in any resultant contract awarded under this RFP has been approved for use by the NINDS for the underlying requirement. The edited HHSAR clauses at 352.227-11, Patent Rights-Exceptional Circumstances and 352.227-14, Rights in Data – Exceptional Circumstances, are included in full text in Article I.4. of the uniform contract schedule of this RFP. Any prospective Offeror must certify and agree to abide by the terms of these clauses if selected for award of a contract. To evidence this agreement, each Offeror is required to complete, sign and include the DEC Acknowledgment (see Attachment 18) as part of its Business Proposal. Submission of this form with the Business Proposal is a Mandatory Qualification Criteria as per Section M. Prospective Offerors are cautioned that failure to provide a completed DEC Acknowledgment as part of their Business Proposal may render said Business Proposal unacceptable.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than July 22, 2024, 4:00 P.M., Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted nor evaluated for a possible award.

A representative of Offeror’s organization who is authorized to enter into contracts with the National Institutes of Health must sign the Technical Proposal and Business Proposal prior to submission.

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.

Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/HowToSubmit and in Attachment 1.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov). Only organizations who are registered with SAM.gov will receive e-mail notifications of updates to this solicitation, In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate https://ecps.nih.gov/ proposals and award a contract without discussions. Therefore, Offeror’s initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers − This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this RFP.

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

− The RFP shall take precedence if any content in this document is contradictory.

The NINDS appreciates your interest in this RFP and looks forward to receipt of your proposal.

Requests for any information concerning this RFP should be directed to the undersigned or Marlene Milgram at marlene.milgram@nih.gov.

Sincerely, Rieka Plugge Contracting Officer, Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515 mailto:marlene.milgram@nih.gov mailto:rieka.plugge@nih.gov

75N95024R00077

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 130

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

06/07/2024 X

NIDA-EXEC

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

1600 ED 07/22/2024

MARLENE E MILGRAM +13 64

MILGRAMM2@NIDA.NIH.GOV

015-9408

X

X

X

X

X

X

X

X

X

X

X

X

X

PAGE(S)

RIEKA N. PLUGGE

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

1-2 6-7

9-17 20-22 24-31 32-52

53-72

74-82

83-124

125-128

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 130

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N95024R00077

(A) (B) (C) (D) (E) (F)

Period of Performance: 01/15/2025 to 01/14/2035

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. OPTION PRICES

4. PROVISIONS APPLICABLE TO DIRECT COSTS

5. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications/Work Statement

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging, Marking, and Shipping

SECTION E - Inspection and Acceptance

FAR 52.246-8 Inspection of Research and Development - Cost-Reimbursement. (MAY 2001)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998)

4. FAR 52.242-15 Stop-Work Order. (AUG 1989)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. TASK ORDER PROCEDURE

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. GOVERNMENT PROPERTY

7. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. RESEARCH AND DEVELOPMENT DATA IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM

3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-

FUNDED RESEARCH

5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

6. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES

7. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

8. OMB CLEARANCE

9. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

10. GUN CONTROL

11. OPTION PROVISION

12. SUBCONTRACTING PROVISIONS

14. CONFIDENTIALITY OF INFORMATION

15. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

16. PUBLICATION AND PUBLICITY

17. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

18. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

19. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

20. SHARING RESEARCH DATA

21. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

22. CONSTITUTION DAY

23. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

SECTION I - Contract Clauses

I.1. GENERAL CLAUSES

I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

I.3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

I.5. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

1. FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. (JAN 2017)………………………………………….74

2. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021)

3. FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation. (OCT 2020)

4. FAR 52.209-12 Certification Regarding Tax Matters. (OCT 2020)

SECTION L - Instructions, Conditions, and Notices to Bidders

L.1. FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (JAN 2017)

L.2. FAR 52.204-6 Unique Entity Identifier. (OCT 2016)

L.3. FAR 52.204-7 System for Award Management (OCT 2018)

L.4. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021) - Alternate I (OCT 1997)

L. 9. FAR 52.222-24 Preaward On-Site Equal Opportunity Compliance Evaluation. (FEB 1999)

L.10. FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer. (JUL 2013) ...121

L.11. FAR 52.233-2 Service of Protest. (SEP 2006)

L.13. FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

L.14. HHSAR 352.219-70 Mentor-Protege Program. (DEC 2015)

SECTION M - Evaluation Factors for Award

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institutes of Neurological Disorders and Stroke (NINDS) Blueprint Neurotherapeutics Network (BPN) has a need for full-service drug formulation and manufacturing operation and facility to support the BPN's Drug Manufacturing and Formulation Program (DMFP). The DMFP is a key component of the BPN programs for the development and manufacturing of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug-(IND) enabling studies, and clinical trials used to develop therapeutics effective in treating neurological disorders/diseases.

The scope of work to be performed under the IDIQ contracts resulting from this solicitation will require Contractor(s) to conduct active pharmaceutical ingredient (API) synthesis and development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The scope of work will also include process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, and distribution. The scope of work will also include preparation of data and documentation for all chemistry, manufacturing, and controls (CMC) regulatory documents in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA).

2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $5,000.00 (minimum) nor more than a total of $ 49,999,999.00 (maximum) for successful performance of this contract.

b. This IDIQ contract has a total ordering period of ten (10) years. As necessary, NINDS will issue Task Orders for the Contractor to perform any or all of the Performance Activities in the Statement of Work (SOW). It is anticipated that these task orders will be cost reimbursement, completion type, and the fixed fee for individual task orders will be negotiated by task order.

For each task order, the resultant contractor will be required to provide a specific quantity of labor hours in specific labor categories applicable to key personnel, and the labor hours will be incurred for work performed during a specific period of time. The IDIQ Contract shall also allow for the issuance of one fixed-price task order for Performance Activity 1. Payment for a cost reimbursement task order shall be based upon effort and completion of project tasks in the task order statement of work. To monitor the progress of any resultant cost reimbursement, completion type task order, the contractor shall submit a report showing the results achieved through application of the required level of effort. The issuance of completion type task orders javascript:void(0) shall also be allowed if more well-defined tasks for known DMFP projects arise. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work or the percent of total effort expended), as determined by the Contracting Officer, and shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in Section I of the contract. Payment for fixed fee shall not be made in less than monthly increments.

c. The costs set forth in this ARTICLE will cover the estimated contract period of 01/15/2025 through 01/14/2035.

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

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

3. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists only of a resultant task order Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR Clause 52.217 Option for Increased Quantity, FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item, FAR Clause 52.217-8 Option to Extend Services set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) 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 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 fixed price of this contract will be increased as set forth in paragraph c., below.

4. 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.

5. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

a. Personal Services and Inherently Government Functions

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor.

If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

b. Site Visits

The NINDS anticipates making visits to the Contractor facility, as needed. Contractor shall be responsible for making the facility available for a visit and arranging meetings with appropriate personnel.

c. Manuscripts and press releases

Manuscripts for scientific publications and press releases shall be considered to include the public release of information to any medium. The Contractor shall not submit a final manuscript or publish a press release related to this contract without receiving prior concurrence from the Contracting Officer's Representative (COR). The Contractor shall submit an advance copy of the document to the

Contracting Officer and COR. Upon acknowledgment of receipt, the COR will have ten (10) working days to respond with concurrence or comments. In the event that the COR does not communicate concurrence or comments to the Contractor within ten (10) working days following acknowledgement of receipt of the advance copy, concurrence may be presumed.

d. Informed Consents

All informed consents related to human research materials shall be approved in writing and in advance by the COR.

SECTION C - Description/Specifications/Work Statement

STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 06/07/2024, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

1. REPORTING REQUIREMENTS

All reports shall be submitted electronically. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

4. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) hard copies of these reports will be required as follows:

[ ] Monthly

[X] Quarterly

[ ] Semi-Annually

[ ] Annually

[ ] Annually (with a requirement for a Draft Annual Report)

[X] Final - Upon final completion of the contract

[ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

The Contractor shall be required to prepare and deliver the following reports as part of their performance responsibilities under the contract as follows:

1. Technical Reports:

a. Conference Call Summaries

The Contractor shall be required to generate and deliver summaries of all conference calls conducted in performance of work under the contract. The summary shall consist of a bulleted list of decisions made and action items identified on the call. These summaries shall be sent via secure e-mail to all participants within 48 hours of each call. The exact number and timing for such calls will depend on the specifics and circumstances surrounding each individual project.

b. Quarterly Progress Reports

The Contractor shall be required to submit Quarterly Progress Reports due within 5 business days of the end of the reporting period and shall describe all contract-related work accomplished during the preceding 3 months. Reports shall summarize progress made on active Task Orders, describe activities planned for the ensuing reporting period, identify deviations from prior plans, provide updated timelines, and describe technical or administrative problems encountered and their resolution or proposed corrective action.

c. API Reports

1) Final API Technology Transfer Report

This report shall include (1) a summary of the experiments performed and the data produced with appropriate certifications and quality reports, and (2) the Contractor's assessment of the suitability of the candidate molecule. The material safety and data sheet (MSDS) shall be drafted and provided as part of this final report. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

2) Final API Process Development Report

Provide written comparisons of initial process proposed and the final accepted process for each scale up task ordered by COR. This report shall include (1) a summary of the experiments performed and the data produced with appropriate certifications and quality reports, and (2) the Contractor's assessment of the suitability of the candidate molecule. The assessment of the final component shall include discussion on the purity, yield, synthesis efficiency, time, cost, environmental savings and a proposed timeline for scale up. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

3) Final API Synthesis Report

Provide written comparisons of initial chemistry proposed and the final accepted chemical synthesis for each scale up task ordered by COR. This report shall include (1) a summary of the experiments performed and the data produced with appropriate certifications and quality reports, and (2) the Contractor's assessment of the suitability of the candidate molecule. The report shall also include the certificate of analysis, the partial DMF for chemical synthesis and a summary of modifications required to optimize yield and efficiency. The Contractor shall provide this report to the COR and as specified in

4) Final API Analytical Method Validation Reports

\For each API analytical method that was validated (e.g. assay for purity, assay for related substances, residual solvent assay etc.) this report shall include a copy of the analytical method and a detailed summary and supporting data for each of the attributes the method was validated against as well as a statistical analysis demonstrating the validation was successful for each attribute. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

5) Final API Analytical Qualification Reports

For each API analytical procedure that was qualified (e.g., 1H-NMR, FTIR etc.) the report shall contain the specific written procedure that was used for API and data (e.g., from a standard) that corroborates that the procedure and instrumentation were functioning properly. The Contractor shall provide these reports to the COR and CO as specified in Section F (Deliverables).

6) Final Drug Product Process Development Report

Provide written comparisons of initial process proposed and the final accepted process for each scale up task ordered by COR. This report shall include (1) a summary of the experiments performed and the data produced with appropriate certifications and quality reports, and (2) the Contractor's assessment of the suitability of the candidate molecule. The assessment of the final component shall include discussion on the purity, yield, synthesis efficiency, time, cost, environmental savings and a proposed timeline for scale up. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

7) Final API Stability Reports

These reports shall include a copy of the stability protocol used to assess the stability of each lot of API, a list of the API attributes that were tested at each time point with reference to the analytical procedure used to test each attribute, a summary table for each batch of API containing all the data generated for each attribute at each time point that was evaluated, and an overall written assessment of the general stability behavior of the API. Additional reports and documents such as CMC documents as part of the IND package should be delivered to the COR upon request. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

d. Drug Product Reports

1) Final Preformulation Report

This report shall include pertinent data and a summary for each test or study that was performed to gain an understanding of the API to determine a way forward develop the API into a drug product (e.g.

crystallinity, hygroscopicity, excipient compatibility, etc.). The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

2) Final Drug Product Analytical Method Validation Reports

For each drug product analytical method that was validated (e.g. assay for purity, assay for related substances, cleaning assay, etc.) this report shall include a copy of the analytical method and a detailed summary and supporting data for each of the attributes the method was validated against as well as a statistical analysis demonstrating the validation was successful for each attribute. The Contractor shall provide these reports to the COR and CO as specified in Section F (Deliverables).

3) Final Drug Product Qualification Report

For each drug product analytical procedure that was qualified (e.g., water content, hygroscopicity, XRD, DSC, etc.) the report shall contain the specific written procedure that was used for the drug product or API and data (e.g. from a standard) that corroborates the procedure and instrumentation were functioning properly. The Contractor shall provide this report to the COR and CO as specified in

4) Final Formulation Development Report

This report shall summarize all of the studies performed that guided the development of the formulation, selection of formulation components, and manufacturing process for the drug product. The report will include all associated stability assessments including a summary table of all stability data generated on prototype and experimental batches as well as a summary of how the stability data guided the formulation and process studies. Additionally, justification for the manufacturing equipment train chased to make the drug product and rationalization in the selection of the processing parameters for the manufacture of CTM. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

5) Final CTM Manufacturing Report

This report shall include (1) a summary of the experiments performed and the data produced with appropriate certifications and quality reports, (2) the Contractor's assessment of the manufacturing suitability of the candidate molecule and (3) the Batch Records for each batch of manufactured CTM. Additional reports, estimated cost of goods and documents such as Chemical Manufacturing Control (CMC) documents as part of the IND package should be delivered to the COR upon request. The Contractor shall provide this report to the COR and as specified in Section F (Deliverables).

6) Final CTM Stability Reports

These reports shall include a copy of the stability protocols used to assess the stability of each batch of CTM, a list of the CTM attributes that were tested at each time point with reference to the analytical procedure used to test each attribute, a summary table for each batch of CTM of all the data generated for each attribute at each time point that was evaluated, and an overall written assessment of the general stability behavior of the CTM. Additional reports and documents such as CMC documents as part of the IND package should be delivered to the COR upon request. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

7) Final Supply Management Report

This report shall include a summary of all packaging, labeling (including samples of labels), storage conditions, shipping records, and final disposition and reconciliation of CTM for each batch of CTM and placebo used in a clinical trial. The report shall also include the standard operating procedure for storage, detail description of the intermediate and final compound handling controls, documentation the compound integrity was maintained, guidelines for distribution that ensures safety, and transportation records. The Contractor shall provide this report to the COR and CO as specified in

8) Task Order Final Report

A Task Order Report is due on or before the completion date of the Task Order and shall describe the work accomplished under the Task Order. The Contractor shall provide this report to the COR and CO as specified in Section F (Deliverables).

e. Final Report

On or before the expiration/termination date of the contract, the contractor shall submit a comprehensive final report to the CO and COR that also summarizes the number of projects initiated over the course of the contract and their outcomes. This final report should also summarize lessons learned that may be applicable to future NIH drug development initiatives.

2. Other Reports/Deliverables:

a. Contractor Non-Disclosure Agreement(s)

The contractor shall complete and submit a signed and witnessed Contractor Non-Disclosure Agreement for each contractor and subcontractor employee who may have access to non-public NIH or NINDS information under this contract. The Contractor Non-Disclosure Agreement is located at https://irtsectraining.nih.gov/nih_non-disclosure_agreement.pdf

b. Section 508 Annual Report

The Contractor shall deliver to the CO and COR a Section 508 Annual Report at the end of each contract year and at completion of this contract. The report shall be delivered via-email, as outlined in Section F of the contract.

5. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

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

2. Subcontracting Reports https://irtsectraining.nih.gov/nih_non-disclosure_agreement.pdf%C2%A0

The Contractor shall submit the following Subcontracting reports electronically via the electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

i. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

ii. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer / Contract Specialist shall be included as a contact for notification purposes at the following e-mail addresses:

Contracting Officer e-mail: [To be specified prior to award]

3. Invention Reporting

In accordance with contract Article C.2. "Invention Reporting Requirement," an Annual Invention Utilization Report shall be due on or before the anniversary date of the contract award and a Final Invention Statement will be due on or before the expiration date of the contract. Note: The same form is used for both the annual and the final report.

4. Service Contract Annual Report

In accordance with FAR 52.204-15 "Service Contract Reporting Requirements for Indefinite-Delivery Contracts," the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2), 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 contract.

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

http://www.esrs.gov/

4) Data reported by subcontractors [if applicable] under paragraph (f) of the subject clause (see full text of clause FAR 52.204-15, "Service Contract Reporting Requirements for Indefinite-Delivery Contracts" at https://www.acquisition.gov/).

5. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report .doc.

Reports must be sent to the following addresses as specified: Please see Article F.2. Deliveries

2. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government] including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892- 7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following e-mail address:

rieka.plugge@nih.gov The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

rieka.plugge@nih.gov

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the

Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - Packaging, Marking, and Shipping

A. 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 compounds, intermediates and finished pharmaceutical product 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 in the Code of Federal Regulations (CFR) regarding packaging, labeling and shipping of 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.

SECTION E - Inspection and Acceptance

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

1. For the purpose of this SECTION, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health 6001 Executive Boulevard Rockville, MD 20892

1. Inspect by Individual

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

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

FAR 52.246-8 Inspection of Research and Development - Cost-Reimbursement. (MAY 2001)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The ordering period of this contract shall be ten years from the date of award. The period of performance for any individual task order shall be specified for any resultant task orders issued.

2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247- 35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule A: Technical Deliverables

(1) Conference Call Summaries 1 e-copy to COR Within 72 hours after conference call end

(2) Quarterly Progress Reports 1 e-copy to COR Five (5) days after end of reporting period

(3) API REPORTS: Final API Technology Transfer Report 1 e-copy to COR Within 10 days of COR’s request

(4) API REPORTS: Final API Process Development Reports 1 e-copy to COR Within 10 days of COR’s request

(5) API REPORTS: Final API Synthesis Reports 1 e-copy to COR Within 10 days of COR’s request

(6) API REPORTS: Final API Analytical Method Validation Reports 1 e-copy to COR Within 10 days of COR’s request

(7) API REPORTS: Final Analytical Qualification Reports 1 e-copy to COR Within 10 days of COR’s request

(8) API REPORTS: Final Drug Product Process Development Reports 1 e-copy to COR Within 10 days of COR’s request

(9) API REPORTS: Final API Stability Reports 1 e-copy to COR Within 10 days of COR’s request