RFP_No._N01TR-19-2005.pdf

REQUEST FOR PROPOSALS (RFP) No. N01TR-19-2005

Project Title: “CRO Support for NCATS Animal Model Development and In Vivo

Pharmacology Studies and Related Services”

Issued by:

Jeffrey Schmidt, Contracting Officer NCATS Section NIDA Office of Acquisition, NIH 6001 Executive Blvd Room 3287, MSC 9531 Bethesda, MD 20892-9534

Primary Point of Contact: Jessica Adams, Contract Specialist E-mail: jessica.adams@nih.gov Phone: (301) 443-8761

Secondary Point of Contact: Jeffrey Schmidt, Contracting Officer E-mail: schmidtjr@mail.nih.gov Phone: (301) 402-1488

ISSUE DATE: April 2, 2018

DATE DUE: May 18, 2018, by 11:00 A.M (Eastern Standard Time)

The National Center for Advancing Translational Sciences (NCATS), NIH, invites you to submit a proposal in response to the requirements of the enclosed RFP No. N01TR-19-2005.

NCATS anticipates awarding this acquisition through a single award indefinite delivery/indefinite quantity (IDIQ) contract with work being completed through the issuance of task orders as needs are identified. The planned IDIQ will have a five-year ordering period. Task Orders will be awarded as the need presents itself; and, depending on the requirements, will be firm fixed price or cost reimbursement type task orders. The contract ordering period will start on or around November 2018. Responses must include technical and pricing proposals for the entire project. Responses must also include separate pricing for each individual option.

This acquisition will not be set aside for small businesses. Because this acquisition will not be set aside, and because the maximum will exceed $700,000, the RFP will require non-small business Offerors to submit a small business subcontracting plan with their business proposal. The North American Industry Classification System (NAICS) Code applicable to this requirement is 541715.

mailto:schmidtjr@mail.nih.gov

Offerors are advised to pay particular attention to Section L of the RFP entitled “Instructions, Conditions, and Notices to Offerors” and Section C entitled “Description/Specification/Work Statement.”

Proposals will be evaluated pursuant to Section M entitled “Evaluation Factors for Award.”

Additionally, offerors are advised to review the list of attachments in Section J entitled “List of Attachments.” This list identifies the attachments that need to be completed and submitted with your proposal, as well as attachments that are included for informational purposes only. Some of the attachments listed in Section J supplement the Instructions in Section L of the main RFP document, so it is important to refer to both Section L and the applicable attachments in Section J when preparing your proposal. The list of attachments in Section J also provides links to fillable forms for many of the attachments that need to be completed and submitted with your proposal.

If you intend to submit a proposal in response to this solicitation, please send a “Proposal Intent Response Sheet,” RFP Section J, Attachment 2, to Jessica Adams, Contract Specialist, jessica.adams@nih.gov.

You must furnish in writing (email is acceptable) any areas of uncertainty, which, in your opinion, require clarification to the Contracting Officer. You must submit your questions on or before April 18, 2018.

It is your responsibility to monitor the web page at http://www.FedBizOpps.gov/ for any amendments that might be issued under this RFP. A separate notice of RFP amendments, if any, to individual sources, will not be made.

Proposals are to be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Please reference Attachment 1, listed in Section J, entitled “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” for instructions and further details.

Please note that you must create an account in the NIH electronic Contract Proposal Submission (eCPS) system/website in order to submit a proposal and it may take up to there (3) business days to establish a new account.

Please apply for a new account early to allow enough time for the registration process.

Please review Section A.8 and 9, and Section L.1, “Instructions to Offerors,” subparagraph (c)(3), addressing late proposals, so that you will be fully aware of the time requirements for submitting your proposal. It is your responsibility to ensure that your proposal is delivered by the due date and time to the NIH electronic Contract Proposal Submission (eCPS) website as required in the RFP.

mailto:jessica.adams@nih.gov.

http://www.fedbizopps.gov/ http://www.fedbizopps.gov/ https://ecps.nih.gov/

Your proposal must be prepared in the format prescribed in the RFP. Please be sure that all documents which you are required to complete and sign (e.g., Representations and Certifications, NIH Form 2043 “Proposal Summary and Data Record”, etc.) are submitted with your proposal (again, please review the list of attachments included in Section J which will indicate which attachments need to be completed and submitted with your proposal, and whether to include them with your Technical Proposal or Business Proposal).

Your proposal must provide a contact name and telephone number, your company name, and complete mailing address. Furthermore, FAR Provision 52.204-7, System for Award Management (SAM), which is applicable to this solicitation, requires that a prospective awardee be registered in the SAM database prior to award, during performance, and through final payment of any contract resulting from this solicitation. In addition to providing your organization’s Tax Identification Number (TIN), FAR Provision 52.204-6, Data Universal Numbering System (DUNS) Number, requires you to submit a DUNS number for your company along with your offer. Contact information for Dun and Bradstreet is provided in the FAR provision at 52.204-6. Please include this information on the first page of your business proposal.

The 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.

No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

Any questions concerning this RFP should be directed to Jessica Adams, Contract Specialist, jessica.adams@nih.gov, (301) 443-8761, or Jeffrey Schmidt, Contracting Officer, schmidtjr@mail.nih.gov, (301) 402-1488.

Regards, Jeffrey Schmidt, Contracting Officer NIDA Office of Acquisitions, NCATS/NIH mailto:jessica.adams@nih.gov mailto:schmidtjr@mail.nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 42 U.S.C. 287(a)

2. Request for Proposal (RFP) Number:

N01TR-19-2005

3. Issue Date:

April 2, 2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : CRO Support for NCATS Animal Models Development and In Vivo Pharmacology Studies and Related Services

6. ISSUED BY:

NCATS Section NIDA Office of Acquisition, NIH 6001 Executive Blvd, Suite 3287, MSC 9531 Bethesda, MD 20892-9531

7. SUBMIT OFFERS TO:

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 will be received at the place specified in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 11:00am, Eastern Standard Time on May 18, 2018. Offers will be valid for 180 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043."

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY

OF PROPOSALS FOR USE WITH THE NIH ELECTRONIC CONTRACT PROPOSAL SUBMISSION (ECPS)

WEBSITE." The OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the eCPS Website.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE ECPS WEBSITE AT THE TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions" LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract.

11. FOR INFORMATION CALL: Jessica Adams, Contract Specialist

PHONE: 301-443-8761

e-MAIL: jessica.adams@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Jeffrey Schmidt Contracting Officer NCATS Section NIDA Office of Acquisition, NIH

RFP Number : N01TR-19-2005

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

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. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

i. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

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12. ROTC Access and Federal Military Recruiting on Campus

13. Certification of Filing and Payment of Taxes

14. Past Performance Information

15. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS. . . 57

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF DATA SHARING PLAN

6. TECHNICAL EVALUATION FACTORS

7. PAST PERFORMANCE FACTOR

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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 Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases. Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts, and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Contracted organizations provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to DPI to assist with probe and assay development, lead selection and optimization, and Investigational New Drug (IND)- or New Drug Application/ Biologic License Application-directed studies.

The objective of this contract is to support the DPI drug development programs by providing services related to the development of animal models and the execution of in vivo pharmacology and related studies, including the use of relevant supporting services needed to accomplish requested tasks.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $5,000 (minimum) nor more than a total of $19,982,863 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract ordering period 11/01/2018 through 10/31/2023.

c. The Government will issue Task Orders based on the work described in SECTION C 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.

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ARTICLE B.4. ADVANCE UNDERSTANDINGS

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

1. Non-Personal Services and Inherently Governmental Functions

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract.

No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative.

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

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

2. 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.

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 regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

3. FAR Deviation Notice

A Determination for Exceptional Circumstances (DEC) for permanent approval of deviations from FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor and FAR Clause 52.227-14, Rights in Data-General was issued by the Director, NIH, on December 6, 2016. The deviated clauses are set forth in Article I.4 and will be included in any resultant award. The DEC is included as RFP Attachment 6.

4. Clearance of Foreign Contracts, Foreign Subcontracts, and Domestic Contracts or Subcontracts with a Foreign Component

The U.S. Department of State (DOS) has authority under the Foreign Relations Authorization Act, to examine all international U.S. Government activities for its impact on national security and foreign policy. For the purpose of ensuring that activities supported outside the United States are consistent with the overall foreign policy objectives of the United States Government, the Department of State requires clearance of proposed R&D projects and projects in support of R&D conducted in a foreign country, and the proposed collection of human and other biological materials from sources in a foreign country. The Division of International Relations (DIR), FIC, must review and approve Institute/Center (IC) clearance documents prior to submission to the Department of State. To request DOS concurrence for international activities related to NIH contracts, FIC collects and forwards information to DOS regarding proposed NIH contracts to foreign institutions, and proposed NIH

- 6 -contracts that involve a foreign component. FIC/DIR transmits DOS concurrence requests through Foreign Award and Component Tracking System to designated U.S. Embassy contacts identified by DOS.

A foreign contract may be awarded only after the NIH has documented clearance by the Department of State. If, at any time during contract performance, a new work requirement is added, Department of State clearance must be obtained prior to the award of the requirement. In addition, Department of State clearance may be required prior to awarding a modification to extend a foreign contract for 12 months or more.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract.

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."

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

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. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 days of the effective date of the contract.

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

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b. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within seven days before staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data - Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees - 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

c. Contractor - Employee Non-Disclosure Agreement(s)

The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. The "Commitment to Protect Non-Public Information - Contractor Agreement" shall be submitted to the Contracting Officer within 14 days of the effective date of the contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/ acquisition/Documents/Nondisclosure.pdf.

d. Contract Deliverables due at Expiration

The Contractor shall provide the following deliverables on or before contract expiration:

i. Sanitization of Government Files and Information - As part of contract closeout and at expiration of the contract, the Contractor shall provide all required documenation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and COR to certify that, at the Government's discretion, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

ii. Contractor Responsibilities Upon Physical Completion of the Contract - The Contractor shall return all Government information and IT resources (i.e., Government information in non-Government owned systems, media, and backup systems) acquired during the term of this contract to the CO and COR. Additionally, the Contractor shall provide a certification that all Government information has been properly santized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and NIH policies.

3. Invention Reporting Requirements

All reports and documentation required by HHSAR Clause 352.227-11, Patent Rights--Exceptional Circumstances (September 2014), 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

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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 annual utilization report and final invention statement shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract.

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.

4. Service Contract Reporting Requirements for Indefinite-Delivery Contracts

The Contractor shall report on services performed as required by FAR Clause 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (January 2014) incorporated by reference in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract and the DELIVERIES Article in SECTION F of this contract.

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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 NCATS Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Center for Advancing Translational Sciences, NIH Divison of Pre-Clinical Innovation 9800 Medical Center Drive Rockville, MD 20850

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The ordering period for this contract shall be from 11/01/2018 through 10/31/2023.

ARTICLE F.2. DELIVERIES

The items specified below, and as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract shall 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 Delivery Method & Addressee

Delivery Schedule

(1) Reporting of Financial Conflict of Interest electronically to COR in accordance with 45 CFR Part 94

(2) Roster of Employees Requiring Suitability Investigations electronically to CO & COR within 14 days after the effective date of contract

(3) Reporting of New and Departing Employees electronically to CO & COR within 7 days following staffing changes for positions that require suitability investigations

(4) Contractor - Employee Non- Disclosure Agreement(s) electronically to CO within 14 days after the effective date of contract

(5) Sanitization of Government Files and Information electronically to CO & COR on or before contract expiration

(6) Contractor Responsibilities Upon Physical Completion of the Contract electronically to CO & COR on or before contract expiration

(7) Invention Reporting Requirement - Annual Utilization Report electronically to CO annually on contract anniversary date

(8) Invention Reporting Requirement - Final Invention Statement electronically to CO on or before contract expiration

(9) Service Contract Reporting Requirements for Indefinite- Delivery Contracts electronically to sam.gov annually on October 31

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.acquisition.gov/?q=browsefar

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SECTION G - CONTRACT ADMINISTRATION DATA

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

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[to be determined by the Government at the time of award]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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

The Government may unilaterally change its COR designation.

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

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

b. Requesting Task Order Proposals.

A Task Order Request for Proposals (TORFP) will be prepared and issued in writing by the Contracting Officer or designated individual for each task order requirement.

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions;

8. Evaluation Factors for Award.

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

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

c. Evaluation and Award of Task Order Proposals

The Government will evaluate 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 making an 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.

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

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. For all cost-reimbursement invoices submitted under this contract, the Contractor shall follow the attached NIH(RC)-1 instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

b. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2, are attached and made part of this contract.

For all fixed-price invoices submitted under this contract, the Contractor shall follow the attached NIH(RC)-2 instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be electronically submitted to the following approving official:

NCATS Contracting Officer NIDA Office of Acquisition, NIH email: TBD

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Invoices

NCATS CMB.

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

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

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

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

f. The Contract Title is:

CRO Support for NCATS Animal Models Development and In Vivo Pharmacology Studies and Related Services

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

b. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

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

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

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ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

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

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

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

(End of Clause)

ARTICLE G.6. INDIRECT COST RATES

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

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at: http://oamp.od.nih.gov/sites/default/ files/appendix_q_hhs_contracting_guide.pdf.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually while the Contractor is performing under an active task order and/or upon task order expiration.

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

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

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH.

The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html and http:// publicaccess.nih.gov.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

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

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the http://www.pubmedcentral.nih.gov http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html http://publicaccess.nih.gov http://publicaccess.nih.gov

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United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email:

ace@aphis.usda.gov; Web…