RFP NIH-NINDS-75N95021R00017 PTTP Ramp-On-S.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: NIH-NINDS-75N95021R00017

PROJECT TITLE: NINDS Pharmacology and Toxicology for Therapeutics Program

(PTTP)

ISSUED BY:

Sneha Vinu Singh Contract Specialist NINDS Section Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: sneha.singh@nih.gov Phone: (301) 480-2443

Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447

DATE ISSUED: April 08, 2021

PROPOSAL DUE: May 10, 2021 at 5:00 P.M. (Eastern Standard Time)

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of this RFP No. NIH-NINDS-75N95021R00017 for the NINDS Pharmacology and Toxicology for Therapeutics Program (PTTP) requirement.

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 is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, and III of the Uniform Contract Format.

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:nancy.lamon-kritikos@nih.gov http://www.sam.gov/ http://www.sam.gov/

NINDS anticipates that multiple-award (MAC) indefinite-delivery, indefinite-quantity (IDIQ) contracts with cost reimbursement or fixed price task order type, will be awarded.

NINDS anticipates that the period of performance of the contract will be as follows:

Date of award to the end of the existing MAC IDIQ’s which is 9/12/26. The contract will contain a minimum equal to the negotiated fixed-price for a contract kick-off meeting and a maximum value of $174,470,000 for the ordering period.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. 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 Contract Specialist and Contracting Officer. Offeror questions must be submitted on or before 5:00 P.M., on April 21, 2021. Offeror questions may be submitted by e-mail to sneha.singh@nih.gov with the subject line:

“RFI – RFP NIH-NINDS-75N95021R00017”

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. 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.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal. It must contain a detailed breakdown of costs for the base period and each option period. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

mailto:sneha.singh@nih.gov

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 7) must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

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

(Business Proposal Instructions) for additional detail.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than May 10, 2021, 5:00 P.M., Eastern Standard Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly.

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

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

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

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

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

The RFP shall take precedence if any of the content in this letter is contradictory.

The NINDS appreciates your interest in this RFP and looks forward to the receipt of your proposal. Requests for any information concerning this RFP should be directed to the undersigned or Sneha Singh at sneha.singh@nih.gov. Discussions with any other individuals should not occur.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto https://beta.sam.gov/

Sincerely, Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892

Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447 mailto:nancy.lamon-kritikos@nih.gov

RFP NIH-NINDS-75N95021R00017

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: 42 U.S.C. 285 j

2. Request for Proposal (RFP) Number:

NIH-NINDS-75N95021R00017

3. Issue Date:

April 08, 2021

4. Set Aside:

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

5. Title: Pharmacology and Toxicology for Therapeutics Program (PTTP)

6. ISSUED BY:

National Institute of Neurological Disorders and Stroke (NINDS) Section Office of Acquisitions, NIDA National Institutes of Health c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

7. SUBMIT OFFERS TO:

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https:// ecps.nih.gov.

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE -Attachment 1 - Packaging and Delivery of the Proposal for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 05:00 P.M., Eastern Standard Time on 05/10/2021. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record,” NIH 2043.

9. This solicitation requires delivery of proposals to be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov as stated in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." Proposals submitted by facsimile or e-mail will not be accepted.

IF YOUR PROPOSAL IS NOT RECEIVED VIA THE ELECTRONIC CONTRACT PROPOSAL

SUBMISSION (ECPS) WEBSITE BY THE DATE AND TIME OF PROPOSAL SUBMISSION, THEN

IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION

L.1 OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov.

11. FOR INFORMATION CALL:

Sneha Singh, Contract Specialist e-mail: sneha.singh@nih.gov / phone: 301-480-2443

COLLECT CALLS WILL NOT BE ACCEPTED

Please submit your proposal intent response or any requests for clarification, additional information, or correction to the Contracting Officer on or before 5:00 P.M., EST, on 04/21/2021. Offeror questions must be submitted by e-mail to sneha.singh@nih.gov with the subject line: " NIH-NINDS-75N95021R00017"

Nancy Lamon-Kritikos Contracting Officer, NINDS Section Contracts Management Branch Red NIDA Office of Acquisitions, NIDA National Institutes of Health https://ecps.nih.gov/ https://ecps.nih.gov/ https://ecps.nih.gov/

Table of Contents

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. - BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. - PRICES/COSTS

ARTICLE B.3. - PROVISIONS APPLICABLE TO DIRECT COSTS UNDER COST-REIMBURSEMENT

TASK ORDERS

ARTICLE B.4. - PROVISIONS APPLICABLE TO FIXED-FEE UNDER COST-REIMBURSEMENT TASK

ORDERS

ARTICLE B.5. - ADVANCE UNDERSTANDINGS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. - STATEMENT OF WORK

ARTICLE C.2. – SPECIAL REQUIREMENTS

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

ARTICLE E.1. – INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. DELIVERIES

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

SECTION G – CONTRACT ADMINISTRATION DATA

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

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

ARTICLE G.3. TASK ORDER PROCEDURE

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

FINANCIAL REPORTING

ARTICLE G.5. INDIRECT COST RATES

ARTICLE G.6. GOVERNMENT PROPERTY

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

ARTICLE G.8. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (December 2013)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

ARTICLE H.2. ANIMAL WELFARE

ARTICLE H.3. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015) . 27

ARTICLE H.4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS

RESULTING FROM NIH-FUNDED RESEARCH

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.7. GUN CONTROL

ARTICLE H.8. OPTION PROVISION

ARTICLE H.9. SUBCONTRACTING PROVISIONS

ARTICLE H.10. INFORMATION AND PHYSICAL ACCESS SECURITY

ARTICLE H.11. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST

ARTICLE H.12. PUBLICATION AND PUBLICITY

ARTICLE H.13. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.15. CONSTITUTION DAY

ARTICLE H.16. CERTIFICATION OF FILING AND PAYMENT OF TAXES

ARTICLE H.17. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR

352.239-74 (December 18, 2015)

ARTICLE H.18. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY

ARTICLE H.19. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

ARTICLE H.20. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

ARTICLE H.21. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS

ARTICLE H.22. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR

352.239-73 (December 2015)

ARTICLE H.23. CONFIDENTIALITY OF INFORMATION

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT CONTRACT WITH

EDUCATIONAL INSTITUTIONS

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT CONTRACT WITH NON-

PROFIT ORGANIZATIONS OTHER THAN EDUCATIONAL INSTITUTIONS

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND

DEVELOPMENT CONTRACT

ARTICLE I.2. GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE RESEARCH AND

DEVELOPMENT CONTRACT

ARTICLE I.3. AUTHORIZED SUBSTITUTIONS OF CLAUSES

ARTICLE I.4. ADDITIONAL CONTRACT CLAUSES

ARTICLE I.5. SERVICE CONTRACT LABOR STANDARDS

ARTICLE I.6. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

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 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) is pursuing the Ramp-On of Multiple Award (MAC) Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts to assess the pharmacokinetics, toxicology and safety of promising compounds to support their eventual use as therapeutics. Under the auspices of the NIH Blueprint for Neuroscience Research Program, and more specifically the NIH Blueprint Neurotherapeutics Network (BPN), (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm), the Pharmacology and Toxicology for Therapeutics Program (PTTP) provides a critical component of the BPN drug development infrastructure. PTTP supports all preclinical pharmacology and toxicology testing needed to inform lead discovery and the selection of a clinical candidate, as well as comprehensive studies needed for regulatory filings such as FDA Investigational New Drug (IND) applications to allow for clinical evaluation of the candidates. In addition, this contract can serve and be utilized for individual development projects outside the Blueprint Network. IDIQ contracts awarded during the Ramp-On process will be incorporated into the existing MAC IDIQ contractor pool. Existing IDIQ contracts have an ordering period of September 13, 2016 through September 12, 2026. The MAC IDIQ maximum value, for all contract-holders combined, is $174,470,000 during the total ten (10) year ordering period of the IDIQ.

ARTICLE B.2. - PRICES/COSTS

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

a. This is a Multiple Award (MAC) 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 the negotiated firm-fixed-price for a contract kick-off meeting (minimum) nor more than a total of $174,470,000 (maximum) for successful performance of this contract.

b. This IDIQ contract has a total ordering period from date of award through September 12, 2026. 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).

c. The NINDS intends to issue Task Order #001 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 (minimum).

d. Task Orders for Performance Area 2, “Pharmacology and Toxicology Studies”, for individual pharmacology and toxicology studies of investigational agents/therapeutics will be competed through a Task Order Request for Proposal (TORFP) process as the need arises. It is anticipated that these Task Orders will be cost-reimbursement (completion and/or level of effort type) or fixed-priced orders and will have variable periods of performance. The Government anticipates the possibility of issuing 8-10 TORFPs under Performance Area 2 during each year of the contract. The actual number of TORFPs issued will depend upon programmatic needs and funding availability, and it may vary from year to year.

Due to changes in priorities within NINDS, the projected workload cannot be precisely described for each year.

e. When the Contractor is awarded a Task Order under Performance Area 2, “Pharmacology and Toxicology Studies,” the Government anticipates concurrently awarding a separate Task Order based on the work described in Performance Area 1, “Management and Operations Support,” and the following schedule.

The Task Order under Performance Area 1, “Management and Operations Support,” will be a fixed-price type Task Order. These services are considered severable and subject to annual appropriations and the exercise of options in accordance with FAR Clauses 52.217-7 and 52.217-9. There will be no more than one Task Order under Performance Area 1, “Management and Operations Support,” at one time. The period of performance of this Task Order, including any exercised options, is not expected to extend past the period of performance of Task Orders awarded under Performance Area 2, “Pharmacology and Toxicology Studies.” Upon delivery and acceptance of the item(s) described in each Task Order under http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm

Performance Area 1, “Management and Operations Support,” the Government shall pay to the Contractor the negotiated firm-fixed-prices set forth below.

SCHEDULE OF CHARGES FOR PERFORMANCE AREA 1

Description of Item Unit Period of Performance Price/Unit

Performance Area 1, “Management and Operations Support” Month Date of Award - 09/12/2021 $TBD

Performance Area 1, “Management and Operations Support” Month 09/13/2021 - 09/12/2022 $TBD

Performance Area 1, “Management and Operations Support” Month 09/13/2022 - 09/12/2023 $TBD

Performance Area 1, “Management and Operations Support” Month 09/13/2023 - 09/12/2024 $TBD

Performance Area 1, “Management and Operations Support” Month 09/13/2024 - 09/12/2025 $TBD

Performance Area 1, “Management and Operations Support” Month 09/13/2025 - 09/12/2026 $TBD

f. Ordering procedures under this contract will be as described in Article G.3., Task Order Procedure, of this contract.

ARTICLE B.3. - PROVISIONS APPLICABLE TO DIRECT COSTS UNDER COST-REIMBURSEMENT

TASK ORDERS

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. - PROVISIONS APPLICABLE TO FIXED-FEE UNDER COST-REIMBURSEMENT TASK

ORDERS

For cost-reimbursement-plus-fixed-fee, level-of-effort (term form) task orders, the negotiated fixed-fee, if any, shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

ARTICLE B.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. Non-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 (CO) to the Contractor. 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’s 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. Contract Number Designation

TBD

c. 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.

d. Ramp-On Procedures

The Government may periodically review the total number of contractors participating under its Pharmacology and Toxicology for Therapeutics Program (PTTP) to ensure that adequate capacity and competition exists for task orders throughout the period of performance of this contract. Over time, the total number of contractors participating under this program 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 PTTP 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 period of performance of this contract program. 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 in the Federal Business Opportunities. 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 program nor exceed the maximum order total as currently established for this program. 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 PTTP contractors.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. - STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated March 22, 2021, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. – SPECIAL REQUIREMENTS

a. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature and shall not be released, disclosed, or otherwise disseminated to any person, organization, etc., except as otherwise directed by the Government.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regards to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

b. Data Rights

All data and the results emanating from or generated on the compounds provided by the Government, along with any summary reports compiled, are considered confidential based on the pre-existing agreements that the NINDS has established with compound sponsors. The contract restricts and prohibits the Contractor’s right to use, release to others, reproduce, distribute, or publish data or other information resulting from testing/evaluations performed under contract. Such data shall not be releasable under the Freedom of Information Act (FOIA) as it is considered proprietary, i.e., trade secrets, and, therefore, could be determined to be exempt from FOIA. Restricted access to data and materials will be maintained at the Contractor’s facility in a secured manner. Special notices or other safeguards will be affixed to any packages containing such data.

c. Materials Transfer Agreement

Additionally, a Materials Transfer Agreement (MTA) may be necessary to implement with the Contributor/sponsor in order to transfer the investigational agent substance (as API or as final dosage formulation) to the Contractor.

Investigational agents will be provided by either the Government via a 3rd party Contractor or Contributor.

The Contractor shall comply with FDA regulations and Contractor’s SOPs for handling investigational agents. The Government or Contributor may request that the Material Transfer Agreement be put into place.

Receipt, handling, storage, and disposition of investigational agents will be in compliance with the Contractor’s SOPs and in compliance with FDA regulations. At the request of the Government, investigational agents may be returned as instructed by the Contracting Officer’s Representative (COR) at any time.

d. Privacy Act System of Records

The applicable Privacy Act System of Records Number (SORN) is specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals. The SORN that is applicable to this contract is: 09-25-0124.

The design, development, or operation work the Contractor is to perform is: The Contractor shall conduct pharmacology and toxicology studies in accordance with the complete protocol requirements for each agent developed by the Contractor and approved by the NINDS Contracting Officer’s Representative.

Records disposition instructions: Destroy PII after processing and retain sanitized records under schedule DAA-0443-2012-0007-0003 for a period of 7 years after cutoff.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked, and shipped in electronic format 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.

ARTICLE D.1. PACKAGING

For the purpose of the reports, "immediately usable and acceptable condition" includes securing the pages together in a suitable and reasonable manner to be agreed upon by the Contracting Officer (CO) and the NINDS Contracting Officer's Representative (COR).

Boxes and/or other types of outer packaging, i.e., containers, wraps, etc., shall be suitable to the type of items being transmitted; and the mode of transportation utilized shall assure that such materials be received in an acceptable condition as needed.

ARTICLE D.2. MARKING

All reports and/or deliverable items under this contract shall be marked on the cover and cover page with the following identifiers.

1. Project Title: "Pharmacology and Toxicology for Therapeutics Program (PTTP)"

2. Contract Number:

3. Name of Contractor:

4. Name of Principal Investigator:

ARTICLE D.3. SHIPPING

Shipping shall be accomplished by reasonable and suitable means to be mutually agreed upon by the Contractor and the NINDS COR.

See Section F for delivery information.

SECTION E - INSPECTION AND ACCEPTANCE

ARTICLE E.1. – 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 NINDS COR is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at either the Contractor’s facility or at the NINDS.

Acceptance of work, materials, services, and reports 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 52.246-9, Inspection of Research and Development (Short

Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The total ordering period of this contract shall be from date of award through September 12, 2026.

ARTICLE F.2. DELIVERIES

The items specified below, and as set forth in Article C.1., Statement of Work, Section 5, Reporting Requirements and Deliverables, shall be delivered F.o.b. Destination as set forth in FAR Clause 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), hereby made a part of this contract, and in accordance with and by the dates specified below:

Description Quantity Due Date

TECHNICAL REPORTS -

PERFORMANCE AREA 1

Quarterly Technical Progress Report 1 e-copy to the

CO and COR 5 calendar days after the end of months 3, 6, and 9 of each year.

The report covering the last quarterly period of each year is due on or before the completion / termination date of the Task Order year.

Final Contract Report 1 e-copy to the CO and COR

On or before the completion/termination date of the contract.

TECHNICAL REPORTS -

PERFORMANCE AREA 2

Task Order Data Reports 1 e-copy to the

Will be determined by terms of each individual Task Order

Draft Task Order Study Report 1 e-copy to the CO and COR

Will be determined by terms of each individual Task Order

Final Task Order Study Report 1 e-copy to the CO and COR

Will be determined by terms of each individual Task Order

Report of Unexpected Event 1 e-copy to the CO and COR

Will be determined by terms of each trial Task Order

OTHER REPORT REQUIREMENTS

– PERFORMANCE AREA 1

Roster of Employees Requiring Suitability Investigations (Monthly IT Roster); List of Personnel with defined roles and responsibilities. Background Investigation – onboarding documentation

1 e-copy to the CO and COR

Initial report due 14 days after contract award. Thereafter, due 5 calendar days after end of each monthly reporting period.

IT Security Plan 1 e-copy to the CO and COR

Due within 30 days after contract award

IT Risk Assessment 1 e-copy to the CO and COR

Due within 30 days after contract award

FIPS 199 1 e-copy to the

Due within 30 days after contract award

IT SA&A Package 1 e-copy to the CO and COR

Due three (3) months after contract award.

Commitment to Protect Non-Public Information - Contractor Employee Agreement

1 e-copy to the CO and COR

Prior to any and all employees working under the contract.

Training Records and Rules of Behavior

1 e-copy to the CO and COR

In conjunction with contract award and annually thereafter or upon request.

Vulnerability Scanning Reports;

POA&M updates; revised security documentation/Agreements, vulnerability and application scans

1 e-copy to the CO and COR

1st report due 40 days after contract award. Monthly reports thereafter due 10 calendar days after end of each monthly reporting period.

Incident Report 1 e-copy to the CO and COR

As soon as possible but no later than within 1 hour of discovery

Protection of Information in a Cloud Environment

1 e-copy to the CO and COR

Within two weeks of contract award

For system or cloud service, additional documentation, such as Disposition/Decommission Plan

1 e-copy to the CO and COR

At contract expiration

FedRamp Authorization 1 e-copy to the CO and COR

Prior to use

Section 508 Annual Report - Electronic and Information Technology Accessibility –

1 e-copy to CO and COR

On or before the anniversary date of contract award.

Annual Invention Utilization Report

1 e-copy to the

CO

On or before the anniversary date of contract award.

Final Invention Statement 1 e-copy to the

CO

On or before the expiration/ termination date of the contract.

Individual Subcontract Report (ISR) Electronic Submission

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

Summary Subcontract Report (SSR) Electronic Submission

October 30th of each contract year.

Financial Conflict of Interest (FCOI) Report

1 e-copy to the

CO

Initial and ongoing

Service Contract Reporting Electronic Submission

October 31 following each contract year

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 http:// www.esrs.gov (if applicable);

http://www.esrs.gov/

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.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

The e-mail addresses for the Contract Specialist/Contracting Officer and Contracting Officer Representative (COR) are as follows:

Contract Specialist/Contracting Officer Sneha Singh Email: sneha.singh@nih.gov

Contracting Officer’s Representative (COR) Name: Shamsi Raeissi Email Address: shamsi.raeissi@nih.gov

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984).

http://www.acquisition.gov/far

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 identified at time of contract award]

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

(5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an 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 in writing, any time during the contract’s period of performance.

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

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

[To be identified at time of contract award]

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders under Performance Area 2, “Pharmacology and Toxicology Studies,” 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 only 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 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 in this contract shall be incorporated in the TORFP and the resultant Task Order by reference. 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 unless stated otherwise.

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

c. Competitive Ordering Process

1. All Contractors within a technical area will receive e-mail notifications advising of the availability of each proposed Task Order requirement. All proposed Task Orders will incorporate all terms of this contract unless otherwise specified in the proposed Task Order.

2. Contractors will be provided adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of the 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 past performance or cost/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 under Performance Area 2, “Pharmacology and Toxicology Studies,” issued over $3,500 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 $3,500 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 $6 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $6 Million, in accordance with FAR 16.505(b)(1)(iv).

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

REPORTING

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH (RC)-2 and NIH Cost-Reimbursement Type

Contracts, NIH (RC)-4 are attached and made part of this contract. The Contractor shall follow the invoice instructions for preparation and submission of invoices related to Task Order awards. In addition, the Contractor shall follow the procedure specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

b. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial

Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract.

The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Approving Officials (Contract Specialist and Contracting Officer), and Contracting Officer’s Representative:

Approving Official: Contract Specialist Name: Sneha Singh Email Address: sneha.singh@nih.gov

Approving Official: Contracting Officer Name: Nancy…