75N95021R00008_Synopsis and Solicitation_Amendment 1.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95021R00008

CRO Support for NCATS Regulatory Affairs Support and Related Services

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95021R00008 and the solicitation is issued as a request for proposals (RFP). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 12 - Acquisition of Commercial Items and is expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06, effective July 12, 2021.

(iv) The associated NAICS code is 541690 and the Small Business size standard is $16.5M.

This requirement is set-aside exclusively for Small Business.

DESCRIPTION

(v) The NCATS requires preclinical and clinical regulatory affairs services that can fully support drug development projects from pre-clinical through clinical phases. Therapies under development can cover a wide range of modalities, such as small molecules and biologics (e.g.antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical or clinical development that requires varying levels of support.

This is anticipated to be a multiple-award indefinite delivery / indefinite quantity contract under which firm fixed-price and/or labor hour task orders will be issued.

(vi) The IDIQ contract(s) will have a five-year order period from TBD 2021 through TBD 2026.

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition and is incorporated by reference. Additional instructions are contained in the Schedule, Section L. This solicitation requires delivery of Phase I submissions as stated in Article L.2. This solicitation also requires delivery of Phase II proposals as stated in Attachment 2, "Packaging and Delivery of Proposal”. If your proposal is not received by the contracting officer or her designee at the place and time specified for the Phase I submission or the Phase II proposals, 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.

(viii) Evaluation factors are provided in the Schedule, Section M. All factors will be evaluated in accordance with the Solicitation.

(ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror

Representations and Certifications—Commercial Items, with offers.

(x) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition, and is incorporated by reference. Additional terms and conditions are included in the Schedule.

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders–Commercial Items, applies to this acquisition. Clauses applicable to this acquisition have been incorporated into the Schedule by reference or in full text.

(xii) Additional requirements and terms and conditions determined by the contracting officer to be necessary for this acquisition are included in the Schedule and attachments. In the event of a conflict or inconsistency between FAR clauses 52.212-1, 52.212-4, 52.212-5, and the Schedule, the Schedule shall take precedence.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

Phase I submissions must be submitted before 12:00:00PM Eastern Time on August 30, 2021 and in accordance with the solicitation (and applicable attachments). Proposals must be submitted before 12:00:00PM Eastern Time on October 14, 2021 and in accordance with the solicitation (and applicable attachments). 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.

Questions must be submitted by email to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov (tel. 301-827-3546) and Rieka Plugge, Contracting Officer, at rieka.plugge@nih.gov (tel. 301-827-7515). Questions for Phase I must be submitted before 12:00:00PM Eastern on August 16, 2021. Questions for Phase II must be submitted before 12:00:00PM Eastern time on August 30 September 29, 2021.

mailto:kimberly.espinosa@nih.gov mailto:rieka.plugge@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:

75N95021R00008

3. Issue Date:

August 4, 2021

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : CRO Support for NCATS Regulatory Affairs Support and Related Services

6. ISSUED BY:

Office of Acquisition National Institutes of Health National Institute on Drug Abuse 11601 Landsdown St.

Bethesda, MD 20852

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 2 of this Solicitation.

8. Proposal Intent Response Forms are due before 12:00:00PM Eastern Time on August 16, 2021. Vendors must complete and submit a Proposal Intent Response Form to participate in Phase I in accordance with Article L.2.a (see Attachment 1, “Proposal Intent Response Form” in Section J – List of Attachments). Vendors will receive electronic delivery instructions for the Phase I submission after the Proposal Intent Response Form is received.

Questions about Phase I are due before 12:00:00PM Eastern Time on August 16, 2021. Responses will be provided before 4:00:00PM on August 20, 2021.

Phase I submissions are due before 12:00:00PM Eastern Time on August 30, 2021. Vendors will receive electronic delivery instructions for the Phase I submission after the Proposal Intent Response Form is received.

Phase I Advisory Notifications are anticipated to be made on or around September 20, 2021.

Questions about Phase II are due before 12:00:00PM Eastern Time on September 29, 2021. Responses will be provided before 4:00:00PM Eastern Time on October 8, 2021.

Phase II proposals are due before 12:00:00PM Eastern Time on October 14, 2021. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 2, "Packaging and Delivery of the Proposal," until 12:00:00PM Eastern Time on October 14, 2021. Offers will be valid for 120 days unless a different period is specified by the offeror on Attachment 7, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in Attachment 2, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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1. Requisition or other Purchase Authority: 42 U.S.C. 287(a) IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Rieka Plugge

PHONE: 301-827-7515

e-MAIL: rieka.plugge@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kimberly Espinosa Contract Specialist, NCATS Section NIDA Office of Acquisition kimberly.espinosa@nih.gov

Rieka Plugge Contracting Officer, NCATS Section NIDA Office of Acquisition Rieka.plugge@nih.gov https://www.sam.gov/SAM/

RFP Number : 75N95021R00008

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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. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

f. COMMITMENT OF PUBLIC FUNDS

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

12. Past Performance Information

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Information Other than Cost or Pricing Data

3. Salary Rate Limitation

4. Total Compensation Plan

5. Other Administrative Data

6. Subcontractors

7. Proposer's Annual Financial Report

8. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

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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) has a need for regulatory affairs services that can fully support drug development projects from pre-clinical through clinical phases. Therapies under development can cover a wide range of modalities, such as small molecules and biologics (e.g. antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical or clinical development that requires varying levels of support.

This may include drugs, medical devices used in drug delivery, or drug-device combinations.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,000 (minimum) nor more than a total of $19,364,880 (maximum) for successful performance of this contract.

b. The prices set forth in this ARTICLE will cover the contract period TBD 2021 through TBD 2026. This IDIQ contract will have a total ordering period of five years.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract. Task orders may be firm fixed price, labor hour, or a combination of the two.

d. The Government intends to award Task Order No. 1, Preparation of an Investigational New Drug (IND) application with Food and Drug Administration (FDA) for a treatment for Jansen’s Metaphyseal Chondrodysplasia, concurrent with this award. See Attachment 4, “Task Order Request for Proposals”. Subsequent task orders will be issued according to the ordering procedures set forth in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.3. 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.

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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 Attachment 3, “IDIQ Statement of Work”, in SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in accordance with ARTICLE F.2 DELIVERIES. Any or all of the listed reports may be required by any task order issued under the IDIQ contract resulting from this solicitation. All reports are required to be submitted in the required format and in accordance with Agency regulations and requirements, as applicable.

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).

A. INFORMATION AND/OR PHYSICAL SECURITY REPORTING REQUIREMENTS

1. Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable (see Attachment 10, “Commitment to Protect Non-Public Information Contractor Agreement” in Section J). A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and Contracting Officer Representative (COR) prior to performing any work under this acquisition.

B. TECHNICAL REPORTING REQUIREMENTS

1. Pre-Meeting Status Reports

A Pre-meeting Status Report that documents the efforts performed in the completion of each task and the agenda for the upcoming meeting with the Government.

2. Post-Meeting Minutes

Post-Meeting Minutes that include, at a minimum, a summary of any action items resulting from the meeting with the Government.

3. Kick-off Meeting Presentation

A project kick-off meeting presentation with the Government to familiarize project team members with the project.

4. Communication and Management Plan

A plan that covers information such as a project timeline; project overview; project organization; and work activities, methods, and tools for project activities and documents.

5. Pre-Investigational New Drug (IND) Documentation http://www.hhs.gov/web/508/index.html

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Such documentation may include but is not limited to a complete and finalized pre-IND regulatory package with all final and supporting documentation.

6. Investigational New Drug (IND) Documentation

A complete and finalized IND regulatory package with all final and supporting documentation.

7. Post-Investigational New Drug (IND) Filing Documentation

Such documentation may include but is not limited to formal IND amendments (e.g., responses to clinical hold, responses to FDA request for information, IND annual report, Serious Adverse Events (SAEs), etc.).

8. Nonclinical and Clinical Study Reports

Such documentation may include but is not limited to IND enabling study report(s) for each identified nonclinical or clinical study with all final and supporting documentation.

9. Clinical Documentation

Such documentation may include but is not limited to Clinical Protocols, informed consent and case report forms, protocol amendments, and tracked changed/modifications between protocol amendments, with all final and supporting documentation.

10. Medical Device Component of a Combination Product Documentation

Such documentation may include but is not limited to medical device specifications, biocompatibility study reports, Investigational Device Exemption (IDE).

11. Due Diligence Assessment and Gap Analysis

Such documentation may include but is not limited to a literature search, regulatory landscape analysis report, and drug development plan analysis report.

12. Expedited Pathways and Other Designations Documentation

Such documentation may include but is not limited to Orphan drug designation request and annual reports, Fast Track designation, Breakthrough designation, accelerated pathways designation, Regenerative medicine advanced therapies designation, with all final and supporting documentation.

13. Meeting Support Documentation

Such documentation may include but is not limited to meeting requests, agendas, minutes, presentations, and requests for information, for meetings with the Government or Regulatory Agencies.

14. Transition Plan

A transition plan for an orderly and complete transition/relocation of the task order resources to a successor contractor or to the Government. This plan shall details on the relocation/disposition of: all drafted documents for the Government; all communication exchanges with the Agency on behalf of the Government; unused materials and supplies; manuals and directories developed by the contract; all contract-developed database programs, entries, and file; and all other government property not listed.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

- 8 -statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

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

TBD for each task order

, Room

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

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

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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.

Deliverables shall be titled consistent with the deliverable titles in the IDIQ and task order. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

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

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

c. Inspection and acceptance will be performed at:

National Center for Advancing Translational Sciences, NIH Division 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 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-6, Inspection Time-and Material and Labor Hour (May 2001).

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The total ordering period for this contract shall be from TBD 2021 through TBD 2026. The IDIQ contract(s) awarded as a result of this solicitation will have a total ordering period of five years.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the task order shall be deemed to occur upon performance of the work described in the task order Statement of Work and, upon delivery and acceptance by the Contracting Officer or the duly authorized representative, of the deliveries required by the task order. All deliveries required by task orders issued under this IDIQ 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 any specifications listed in SECTION D. PACKING, MARKING AND SHIPPING.

a. Any or all of the following items, as described in ARTICLE C.2 REPORTING REQUIREMENTS, may be required by any task order issued under this IDIQ contract. All reports are required to be submitted in the required format and in accordance with Agency regulations and requirements, as applicable.

Item Description Delivered To Delivery Schedule A.1 Contractor Non-Disclosure

Agreements CO and COR Prior to the employee performing any work under the task order

B.1 Pre-Meeting Status Reports

All team meeting participants

At least 24 hours prior to team meeting

B.2 Post-Meeting Minutes All team meeting participants

Within 48 hours after team meeting

B.3 Kick-Off Meeting Presentation

CO and COR TBD for each task order

B.4 Communication and Management Plan

CO and COR TBD for each task order

B.5 Pre-IND or Pre-IND Meeting Documentation

CO and COR TBD for each task order

B.6 IND Package CO and COR TBD for each task order B.7 Post-IND Filing

Documentation CO and COR TBD for each task order

B.8 Nonclinical and Clinical Study Reports

CO and COR TBD for each task order

B.9 Clinical Documentation CO and COR TBD for each task order B.10 Medical Device Component of a Combination Product CO and COR TBD for each task order

B.11 Due Diligence Assessment and Gap Analysis

CO and COR TBD for each task order

B.12 Expedited Pathways and Other Designations

CO and COR TBD for each task order

B.13 Meeting Support Documentation

CO and COR TBD for each task order

B.14 Transition Plan CO and COR At least 45 days prior to task order expiration

C.1 Invention Reporting Requirement – Annual Utilization Report

Interagency Edison and

CO

On or before the task order anniversary date

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Item Description Delivered To Delivery Schedule C.2 Ivention Reporting

Requirement – Final Invention Statement

Interagency Edison and

CO

On or before task order expiration

b. The above items shall be addressed and delivered electronically to the recipients listed above.

Contracting Officer Contracting Officer’s Representative (COR)

Team Meeting Participants

TBD for each task order TBD for each task order TBD for each task order

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 not 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]

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 following Alternate COR will represent the Government for the purposes of this contract:

[To be determined]

The Alternate COR is responsible for carrying out the duties of the COR in the event that the COR is unavailable or is not able to perform his/her duties as assigned.

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

The Government may unilaterally change its COR designation.

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

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

(End of Clause)

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

Name Title To be determined for each task order

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ARTICLE G.3. TASK ORDER PROCEDURE

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

a. General

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

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained in the IDIQ contract that apply to a specific contract type shall be incorporated in the TORFP and the resultant task order of that same contract type. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

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

c. Competitive Ordering Process.

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

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will

- 15 -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 approximately equal to cost or price. However, each TORFP will specify how the award decision will be made.

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

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

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued exceeding the micro-purchase threshold unless one of 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 the micro-purchase threshold up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

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

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

ARTICLE G.4. INVOICE SUBMISSION

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

Invoice Instructions for Labor Hour Contracts are also attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor 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 Official (Contracting Officer) and Contracting Officer's Representative:

Approving Official: Contracting Officer

Name- TBD Email Address- TBD

Contracting Officer's Representative

Name- TBD Email Address- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https:// ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

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

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

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. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] 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 https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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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. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

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 Regulatory Affairs Support and Related Services

g. Contract Line Items as follows:

Line Item # Line Item Description

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

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

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

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

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (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. 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

- 18 -addition to the Final evaluation, Interim evaluation(s) will be prepared Annually on the anniversary date of the

IDIQ .

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty 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

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.

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

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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. 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.3. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.4. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.5. OPTION PROVISION

Task orders issued under this IDIQ contract may include options. Unless the Government exercises an option pursuant to the Option Clause set forth in SECTION I., a task order will consist only of the Base Period of the Statement of Work as set forth in the task order. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item and FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the task order. If the Government exercises this option, notice must be given in accordance with the applicable FAR Clause and the price of the task order will be increased as set forth in the task order.

ARTICLE H.6. CONFIDENTIALITY OF INFORMATION

a. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

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d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

f. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

The following information is covered by this article:

Non-public information related to drugs, medical devices, and drug-device combinations for which regulatory affairs services are provided; non-public information relating to the therapies under development; and the regulatory documentation generated.

ARTICLE H.7. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(8), the following individual has been designated as the NIH Ombudsman for task order and delivery order contracts. See also FAR Clause 52.216-32, Task-Order and Delivery-Order Ombudsman (Sept 2019) included in Section I.

For Non R&D Contracts:

Dr. Richard G. Wyatt NIH Competition Advocate 1 Center Drive, Room 160, MSC 0151 Bethesda, MD 20892-0151 Phone: (301) 496-4920 E-mail: WyattRG@mail.nih.gov

ARTICLE H.8. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is: https://oig.hhs.gov/fraud/report-fraud/ and the mailing address is:

US Department of Health and Human Services Office of Inspector General

ATTN: OIG HOTLINE OPERATIONS

P.O. Box 23489 Washington, D.C. 20026

ARTICLE H.9. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. CONFIDENTIALITY AND NONDISCLOSURE

Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and mailto:WyattRG@mail.nih.gov https://oig.hhs.gov/fraud/report-fraud/

- 21 -shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and…