RFP No. 75N95024R00050.pdf

75N95024R00050

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

1 104

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

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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

04/19/2024 X

NIDA-EXEC

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

See Attachment 1: Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

1400 ED 07/01/2024

KIMBERLY A ESPINOSA +13 46

kimberly.espinosa@nih.gov

018-2735

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PAGE(S)

KIMBERLY A. ESPINOSA

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

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

4-6

7-11 14-18 19-25 26-34

35-57

58-59

61-94

95-104

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

RFP Number : 75N95024R00050

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. 52.203-98 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (DEVIATION)

16. Past Performance Information

17. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

18. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, HHSAR 352.270-5(a) (December 2015)

5. Research Involving Live Vertebrate Animals

6. Enhancing Reproducibility through Rigor and Transparency

7. Obtaining and Disseminating Biomedical Research Resources

8. Section 508 accessibility standards for HHS Web Site Content and Communications Materials

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Certified Cost or Pricing Data

4. Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost and Pricing Data, FAR Clause 52.215-20 (Nov 2021)

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege 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

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, IF NECESSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute on Neurological Disorders and Stroke (NINDS) has a need for manufacturing and nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for National Institutes of Health (NIH) drug discovery and development programs. To that end, several NIH programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract as contemplated by FAR 16.504.

The Contractor shall be reimbursed by the Government in an amount not less than $1,000 (minimum) nor more than a total of $149,200,000 (maximum) for successful performance of this contract.

b. The $149,200,000 is the maximum combined amount for all contract holders under the program for Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders.

c. This IDIQ contract has a total ordering period through September 29, 2030. As necessary, NINDS will issue Task Orders for the Contractor to perform any or all of the Performance Activities listed in the Statement of Work

(SOW).

d. The NINDS intends to issue a task order concurrent with this award. This task order award will obligate an amount not less than the negotiated firm-fixed-price for a contract kick-off meeting and will satisfy the contract minimum.

e. The costs set forth in this ARTICLE will cover the contract’s total ordering period.

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

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

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

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 Technical 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. Ramp-On Procedures

The Government may periodically review the total number of contractors participating under the IDIQ to ensure that adequate capacity and competition exists for task orders throughout the IDIQ period of performance. Over time, the total number of participating contractors may fluctuate due to various reasons, including a contractor’s ability to perform, industry consolidation, significant changes in program direction and/or priorities, technology advances in drug development processes or procedures, general economic conditions, or other reasons.

If it is determined to be in the best interest of the Government to re-open the IDIQ to new contractors, the Government will announce an open season and solicit new offers by issuing a Request for Proposals (RFP) at any time during the IDIQ period of performance. This re-opening procedure is referred to as “Ramp-On.”

Any Ramp-On decision will be advertised via a Request for Proposals (RFP) availability notice that will be published on SAM.gov. The RFP availability notice will provide an estimate of the RFP release and closing dates and the number of new awards that the Government intends to make. The Ramp-On solicitation and the review and award selection process will be subject to all applicable federal procurement laws and regulations. Any offeror meeting the eligibility requirements as may be identified in the RFP may submit a proposal.

Any resultant contract award will not extend beyond the period of performance remaining under the IDIQ nor exceed the maximum order total as currently established. In addition, any new contractor will be eligible to compete for future task orders with the same rights and obligations of any of the other existing contractors under the IDIQ.

d. Human Materials

Any acquisition and/or supply of human specimen materials, requires advance written approval from the Contracting Officer.

e. The following research is not anticipated to take place under this contract:

Human fetal tissue;

Human Stem Cell Research;

Recombinant or Synthetic Nucleic Acid Molecules

Large-scale Human or Non-Human Genomic Data

HeLa Cell Whole Genome Sequence Data

Agent or Toxin that is Listed in the U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC)

Highly Pathogenic Agent

f. 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.

g. 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

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 04/15/2024, 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.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Technical Progress Reports

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 electronic version(s) 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 / task order [ ] Final - Upon final completion of the contract / task order (with a requirement for a Draft Final Report)

Comprehensive Project Plan

When tasked to work on a project via a TO, Contractors shall work with the COR, CO, and other stakeholders identified by the COR to deliver a comprehensive project plan, including work breakdown structures, timelines, key milestones and deliverables, Go/No-Go decision points, resource allocation, budget, intellectual property terms, and a risk mitigation plan.

Standard Operating Procedures

Contractors shall, upon request by the COR, submit any SOPs, method descriptions, and references to be used in the implementation of the studies. Contractor SOPs will be treated as confidential, and how much detail is revealed and at what time can be discussed.

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

Preliminary Data Reports

After completion of the in-life portion of the study, the Contractor shall prepare a preliminary data report, to be submitted within 5 calendar days from the end of in-life portion of the study. Within 10 calendar days of submission of the data report, the Contractor shall submit a full draft report for review and comment by the COR. After receipt of COR comments, raw data and a final study report shall be delivered and /or transferred to a specified NINDS database.

Final Data Reports

The Contractor in coordination with the NINDS data management representative shall coordinate a seamless transfer of raw and analyzed data, statistical and method(s) of analysis into the NINDS database within 1 week of finalization on study reports.

Comprehensive Summary Reports

As directed by the NINDS COR, a comprehensive report of all studies completed through this contract shall be completed within 45 days after final test results are submitted for each Investigational Agent. Other less comprehensive summaries for “pilot studies and special projects” shall have a 30-day completion requirement for each separate candidate selected.

Quarterly Progress Reports

Quarterly Progress Reports for all testing summaries shall be provided in an approved electronic format to the COR.

Quarterly Reports shall comprise a) a summary of all testing performed in the performance period; b) the status of all projects under development (i.e. new model development, pilot studies), problem areas and any performance delays encountered or that may impede future performance; c) a list of comprehensive summary reports in preparation or completed during the reporting period and d) Solutions to identified problems encountered during the reporting period if any. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. Reports shall be due on or before the 10th calendar day following each reporting period. The Contractor shall send two copies of the Quarterly Progress Reports, one to the COR and one copy to the CO.

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 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.

Final Progress Report/ Summary of Salient Results

Upon final completion of the contract/TO, the Contractor shall deliver a comprehensive final report to the CO and COR that briefly summarizes all the 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 Biologics drug development programs. The Contractor will also 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.

Manufacturing Reports

1. Minutes of project team meetings held during the month, due by the 15th of the following month

2. Monthly (or biweekly as necessary) Periodic Project Status Reports, due before each Project Team Meeting

3. Development reports for each process development phase, due after completion of each phase

4. Study reports for each analytical method development, due after completion of each method development

5. Study protocols and study reports for each analytical method qualification. Reports due after completion of each method qualification

6. Executed batch records for manufacturing campaigns

7. Certificates of Analyses. Due at the delivery of each preclinical, engineering and cGMP batch

8. CMC reports. Due after delivery of GLP and/or cGMP batch for each product.

9. Stability study protocols and stability study reports. Study Protocols are due before the start of stability studies.

Stability study reports are due after each sample pull

Nonclinical Reports

1. Minutes of project team meetings held during the month due by the 15th of the following month

2. Monthly (or biweekly as necessary) Periodic Project Status Reports, due before each Project Team Meetinh

3. Study protocols and study reports. Study protocols are due before study initiation and study reports are due after completion of each study

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

2. Subcontracting Reports

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

1. 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

2. 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] http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45%3A1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45%3A1.0.1.1.51&idno=45 http://www.esrs.gov/

3. Invention Reporting

In accordance with contract Article C.3. "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.", contained in full text in Article I.4. of the 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) 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.

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 shall 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: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.sam.gov/ https://www.acquisition.gov/ http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

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

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

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.

http://www.iedison.gov/

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Contracting Officer's Representative (COR) 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

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

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

FAR Clause 52.246-7, Inspection of Research and Development - Fixed Price (August 1996).

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

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

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. ORDERING PERIOD

The ordering period of this contract shall be the date of award through September 29, 2030. The period of performance shall be specified for any individual resultant task orders issued.

ARTICLE F.2. DELIVERIES

NOTE: Technical Deliverables are only to be completed, as applicable, if Contractor is awarded one or more task orders.

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:

Item Description Quantity Delivery Schedule

A: Technical Deliverables – General

(1) Comprehensive Project Plan 1 e-copy to CO and

COR

Will be determined by terms of each individual task order

(2) Standard Operating Procedures 1 e-copy to COR Upon request by the COR

(3) Preliminary Data Reports 1 e-copy to COR Within 5 days after completion of in-life portion of study for any resultant task order

(4) Final Data Reports 1 e-copy to COR Within 1 week of finalization on study reports for any resultant task order

(5) Comprehensive Summary Reports 1 e-copy to COR Within 45 calendar days after final test results are submitted for each investigational agent for any resultant task order

(6) Quarterly Progress Reports 1 e-copy to CO and COR

Within 10 calendar days following the reporting period for contract/task order

(7) Conference Call Summaries 1 e-copy to COR Within 48 hours of each call

(8) Final Progress Report/Summary of Salient Results

1 e-copy to CO and COR

Upon final completion of the contract/task order

B: Task Area 1 – Manufacturing

Deliverables

(1) Small-scale non-GMP biological therapeutics lots for R&D studies

Will be determined by terms of each individual task order

(2) Biological therapeutics lot for IND-enabling GLP toxicology studies

Will be determined by terms of each individual task order

(3) Small-scale non-GMP biological therapeutics lots for R&D studies

Will be determined by terms of each individual task order

(4) Project Team Meeting updates (in person or teleconferences)

1 e-copy to COR (meeting minutes)

Monthly (or biweekly as necessary);

meeting minutes due by the 15th of the following month

(5) Periodic Project Status Reports 1 e-copy to COR Monthly (or biweekly as necessary);

due before each Project Team Meeting

(6) Development reports for each process development phase

1 e-copy to COR Due after completion of each phase

(7) Study reports for each analytical method development

1 e-copy to COR Due after completion of each method development

(8) Study protocols and study reports for each analytical method qualification

1 e-copy to COR Due after completion of each method qualification

(9) Executed batch records for manufacturing campaigns

1 e-copy to COR Will be determined by terms of each individual task order

(10) Certificates of Analyses 1 e-copy to COR Due at the delivery of each preclinical, engineering and cGMP batch

(11) CMC reports 1 e-copy to COR After delivery of GLP and/or cGMP batch for each product

(12) Non-GMP lots of Biologics, if required Will be determined by terms of each individual task order

(13) cGMP lots of Biologics suitable for clinical use

Will be determined by terms of each individual task order

(14) Stability study protocols and stability study reports

1 e-copy to COR Study Protocols are due before the start of stability studies. Stability study reports are due after each sample pull

(15) Completing all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling

Will be determined by terms of each individual task order

(16) Maintaining up to date GLP and cGMP standard operating procedures

Ongoing

(17) Participation in LDT, ad hoc meetings, and teleconferences or in person meetings

As required by COR

C: Task Area 2 – Nonclinical Deliverables

(1) Project Team Meeting updates (in person or teleconferences)

1 e-copy to COR (meeting minutes)

Monthly (or biweekly as necessary);

meeting minutes due by the 15th of the following month

(2) Periodic Project Status Reports 1 e-copy to COR Monthly (or biweekly as necessary);

due before each Project Team Meeting

(3) Ad hoc study update team meetings As required by COR

(4) Stability study protocols and stability study reports

1 e-copy to COR Study Protocols are due before the start of stability studies. Stability study reports are due after each sample pull

(5) Maintaining up to date GLP standard operating procedures in accordance with regulatory guidance

Ongoing

(6) Participation in lead development team (LDT), ad hoc meetings, and teleconferences or in person meetings

As required by COR

D: Administrative and Regulatory Reports

(1) Reporting of Financial Conflict of Interest

(FCOI)

1 e-copy to CO See Article C.2(b)(1) for details.

(2) Service Contract Annual Report Electronic Submission (external)

October 31st following each contract year

(3) Individual Subcontract Reports (ISR) Electronic Submission (external)

April 30th and October 30th of each contract year; and a final report on or before expiration date of contract.

(4) Summary Subcontract Report (SSR) Electronic Submission (external)

October 30th of each contract year.

(5) Annual Invention Utilization Report 1 e-copy to CO On or before the anniversary date of contract award

(6) Final Invention Statement 1 e-copy to CO On or before the expiration/ termination date of the contract

(7) Section 508 Annual Report 1 e-copy to CO and COR

On or before the anniversary date of contract award

(8) Contract Closeout Documents 1 e-copy to CO Upon/after contract completion

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

Addressee Deliverable Item No

Contracting Officer (CO) A1, A8, D1, D5-D8

Contracting Officer's Representative (COR) A1-A8, B4-B11, B14, C1, C2, C4, D7

c. The Contractor shall provide all reports to the CO and the COR in electronic formats. Electronic formats can include: Microsoft Word; Excel; PowerPoint; Project, Access; or SAS format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Any paper/ hardcopy documents/reports that may be 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).

d. Contract Closeout: In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for and provide the following items:

i. Indirect cost rate proposals for all years (in which a proposal was not previously submitted);

ii. Final property inventory (excluding intellectual property) and Standard Forms 1428 and 1429 (if applicable);

iii. Settling all subcontract costs and any issues thereunder;

iv. Subcontracting compliance reports for all years to the electronic subcontract reporting system at https://www.esrs.gov (if applicable);

v. Final patent and royalty reports;

vi. A contractor's release of claims, i.e.,Contractor's closing statement; Contractor's Assignment of Refunds, Rebates, and Credits; and

vii. A final invoice or completion voucher.

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

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.

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

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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

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

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

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

Name Title

[To be specified at time of award]

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.

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

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

c. Competitive Ordering Process.

1. All contract holders shall be eligible to compete for both Task Area 1: Manufacturing and Task Area 2:

Nonclinical Studies.

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

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

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

● Understanding of the requirements;

● Experience and capability on similar tasks;

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

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

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

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

● References to evaluate past performance; and

● Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

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

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

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government.

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

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $10,000 unless the following exception(s) apply:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

i. For orders exceeding $10,000 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

ii. For orders exceeding the simplified acquisition threshold up to $5.5 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $5.5 Million, in accordance with FAR 16.505(b)(1)(iv).

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

FINANCIAL REPORT (COST-REIMBURSEMENT)

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract.