CRO_Support_for_NCATS_Bioanalytical_Method_Development_for_Biologics_(RFP_Number_N01TR-17-2004).pdf

OMB #0990-0115

Request for Proposal (RFP) No. N01TR-17-2004

“CRO Support for NCATS Bioanalytical Method Development for Biologics”

Issued by:

Lisa Bielen, Contracting Officer Office of Acquisitions NCATS Section, NINDS Contract Management Branch, NIH 6001 Executive Boulevard Room 3287, MSC 9531 Bethesda, MD 20892-9534

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

DATE ISSUED: January 26, 2017

PROPOSAL DUE DATE: March 28, 2017 by 5:00 P.M. EST

Ladies and Gentlemen:

The National Center for Advancing Translational Sciences (NCATS) invites you to submit a proposal responding to the requirements of the enclosed Request for Proposals (RFP) No.

N01TR-17-2004 for “CRO Support for NCATS Bioanalytical Method Development for Biologics.”

This RFP is released under FULL AND OPEN Competitive Procedures.

NCATS anticipates making multiple Indefinite Delivery/Indefinite Quantity type awards with individually negotiated cost reimbursement and fixed price task orders over a five year ordering period. The guaranteed minimum for each awardee will be $5,000, and the program maximum is $3,912,150.

NCATS prepared this RFP in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a RFP and a contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format. We direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Your attention is further directed to Attachment 2, “Proposal Intent Response Sheet.” Please complete this form and return it to this office on or before February 27, 2017.

The balance of Parts I, II, and III contain provisions, clauses, and special requirements which we will make a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal.

However, you are not to fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those parts prior to contract award. NCATS tailors Parts I, II, and III with the selected offeror to the final negotiation (if negotiations are conducted) and modified, as necessary, for the type of contractor organization, cost and/or fee arrangement, and other elements as negotiated prior to award.

An official authorized to bind your organization must sign the proposal. This solicitation requires delivery of your technical and business proposals as stated in Attachment 1, “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.” Proposals must be submitted to the eCPS website no later than 5 PM EST on March 28, 2017.

You must furnish in writing (email is acceptable) any areas of uncertainty, which, in your opinion, require clarification or correction to the Contracting Officer. You must submit your questions in sufficient time for receipt on or before February 27, 2017. The envelope or e-mail should be marked "Offeror's Questions, RFP No. N01TR-17-2004."

NOTICE: FAR Deviation Notice: A permanent approval for deviations from FAR Clause 52.227- 11, Patent Rights-Ownership by the Contractor and FAR Clause 52.227-14, Rights in Data- General has been approved for any award resulting from this solicitation. The deviated clauses are set forth in Article I.4 and will be included in any resultant award. Please review and provide any comments on these deviated clauses in the offeror's questions due February 27, 2017. These deviations will be discussed further during any negotiations. Additionally, you must sign and return Attachment 6 FAR Deviation Acknowledgement Form with your proposal submission.

Following your proposal submission and our review, the Contracting Officer may seek more information. In accordance with FAR 15.306(a) (3) and FAR 52.215-1, we advise you that the Government intends to evaluate proposals and award a contract without discussions (except clarifications). Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. However, we reserve the right to conduct discussions if the Contracting Officer later decides them to be necessary. The Contracting Officer reserves the right to make no award at all to the RFP. In addition, the RFP may be amended or cancelled as necessary to meet requirements.

You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. We direct special attention to the Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 11. Do not send encrypted files. Use of the above format will hasten review and award. See Section L.2.c. Business Proposal Instructions for additional detail.

Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Format and content requirements of your Technical Proposal are detailed in Section L.2.b. Technical Proposal. Also, you must complete the “Technical Proposal Cover Sheet” and use it as the cover sheet for each copy of your technical proposal. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. We will use this information to ensure that no conflicts of interest exist with the selected review committee members.

The Offeror must submit its Small Business Subcontracting Plan, Travel Policy, Total Compensation Plan and Annual Financial Report with the initial Business Proposal.

If you want to receive an e-mail notice of any amendments to this RFP, you should register on the FedBizOpps website.

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

You should direct all requests for any information concerning this RFP to Jeffrey Schmidt, who may be reached on (301) 402-1488; collect calls cannot not be accepted. Discussions with any other individual outside the NINDS Contract Management Branch should not occur.

Sincerely, Lisa Bielen, Contracting Officer Office of Acquisitions, NCATS/NINDS/NIH

Enclosure http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm http://ocm.od.nih.gov/contracts/rfps/TechCov.htm

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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-17-2004

3. Issue Date:

01/26/2017

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : CRO Support for NCATS Bioanalytical Method Development for Biologics

6. ISSUED BY:

National Center for Advancing Translational Sciences NINDS R&D Contracts Management Branch NIDA Office of Acquisition National Institutes of Health Neuroscience Center 6001 Executive Blvd., Suite 3287, MSC 9531 Bethesda, MD 20852-9531

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, and in the number of copies specified in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 5:00 PM local time on 03/28/2017.

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) at http://www.sam.gov prior to award of a contract.

11. FOR INFORMATION CALL: Lisa V. Bielen or Jeffrey R. Schmidt PHONE: (301) 451-7167 or (301) 402-1488 e-MAIL: lisa.bielen@nih.gov; jeffrey.schmidt@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Lisa V. Bielen Contracting Officer, NCATS NINDS R&D Contracts Management Branch NIDA Office of Acquisition http://www.sam.gov

RFP Number : N01TR-17-2004

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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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. 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

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11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Certification of Filing and Payment of Taxes

13. Past Performance Information

14. Information and Physical Access Security

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Other Considerations

2. Technical Evaluation

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. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. 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) 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: (1) developing and validating sensitive and bioanalytical methods to quantify concentrations of novel biologics; (2) developing assays for measurement of anti-drug antibodies; and (3) providing bioanalytical support for drug concentration and anti-drug antibodies measurements for samples collected from not only animal pharmacokinetic (PK), biodistribution, toxicokinetic (TK) and efficacy studies but also human clinical trials.

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 $5,000 (minimum) nor more than a total of $3,912,150 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract ordering period 11/15/2017 through 11/14/2022.

c. The Government will compete and award task orders based on the work described in SECTION C of this contract.

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

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable: (1) Conferences & Meetings;

(2) Food for Meals, Light Refreshments & Beverages; (3) Promotional Items; (4) Acquisition, by purchase or lease, of any interest in real property; (5) Special rearrangement or alteration of facilities; (6) Purchase or lease of any item

- 5 -of general purpose office furniture or office equipment regardless of dollar value; (7) Travel Costs including Foreign Travel; (8) Consultant Costs; (9) Subcontract Costs; (10) Patient Care Costs; (11) Accountable Government Property;

(12) Printing costs; and (13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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.

a. Requirements Applicable to International Shipping

If any biomaterials are shipped internationally, the Contractor shall be shipped in accordance with International Air Transport Association Regulations.

b. Non-Personal Services and Inherently Government Functions

1. 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.

2. 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.

3. 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.

c. Confidential Treatment of Sensitive Information

1. 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.

2. 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.

d. FAR Deviation Notice

A permanent approval for deviations from FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor and FAR Clause 52.227-14, Rights in Data-General will be sought prior to contract award. The deviated clauses are set forth in Article I.4 and will be included in any resultant award. Offerors must complete and return RFP Attachment 6 Deviaition Acknowledgement Form with their proposal submission.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, 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. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

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 calendar days of the effective date of the task order. (Reference subparagraph A.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this 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. IT Security Plan (IT-SP)

The Contractor shall submit the IT-SP within 30 calendar days after task order award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under the task order. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the task order to which the IT-SP applies.

The Contractor shall review and update the IT-SP annually in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. FIPS 199 Assessment

The Contractor shall submit the FIPS 199 Assessment within 30 calendar days after task order award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

d. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within 5 working days of 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.

(Reference subparagraph E.3.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

e. 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. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/ acquisition/Documents/Nondisclosure.pdf. The Contractor shall submit the "Commitment to Protect Non-Public Information - Contractor Agreement" forms within 14 calendar

- 8 -days of the effective date of the task order, and within 5 working days of a new employee commencing work under the contract.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 working days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

3. Invention Reporting Requirement

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 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. Subcontract Reporting Requirements

The Contractor shall submit Individual Subcontract Reports and Summary Subcontract Reports as required by the SUBCONTRACTING PROVISIONS Article in SECTION H of this contract and the DELIVERIES Article in SECTION F of this contract.

5. 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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6. Team Meeting Reports

The Contractor shall manage either face-to-face or telephone meetings on a biweekly basis, or more frequently (no more than once a week), to keep the COR and the project team apprised of project progress including any issues or problems. The Contractor shall be responsible for securing a physical location for the meeting or a suitable call in number and passcode for the relevant participants and be responsible for moderating the meeting.

At least 24 hours prior to the team meeting, the Contractor shall submit a Pre-meeting Status Report that documents the efforts performed in the completion of each task. The Pre-meeting Status Reports shall include, at a minimum, the following information:

• Program status, to include objectives met, work completed, and outstanding work.

• Notable achievements.

• Issue or obstacles impeding progress and recommended solutions.

• Description of work completed and plans for next reporting period.

• Agenda for corresponding team meeting.

• Status of deliverables/milestones.

• Issues and resolutions.

• Resource planning/status.

Within 48-hours following the team meeting, the contractor shall submit a Post-meeting Summary that includes, at a minimum, a summary of any action items resulting from the meeting.

The contractor shall deliver the Pre-meeting Status Report and the Post-meeting Summary to all meeting participants via secure e-mail.

7. Transition Plan

Within 45 days of task order expiration, the Contractor shall provide the COR with a proposed Transition Plan for an orderly and complete transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/ disposition of: unused materials and supplies; manuals and directories developed by the Contractor;

and all other government property not listed. Upon written direction by the Government, the Contractor shall transfer all Government property as directed, and fully cooperate with any successor Contractor and the Government to ensure an efficient transfer.

8. Interim Study Reports

The Contractor may be requested to prepare and deliver Interim Study Reports within 30 calendar days when such a request is made for a particular need. The Interim Study Reports shall be in a format and of sufficient detail to include in a regulatory (IND) submission to US Food and Drug Administration or equivalent regulatory body.

9. Final Study Reports

The Contractor shall prepare and deliver a Final Study Report within 45 calendar days following the completion of the task. The Final Study Report shall be in a format and of sufficient detail to include in a regulatory (IND) submission to US Food and Drug Administration.

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10. Summary of Salient Results

The Contractor shall prepare and deliver a summary (not-to-exceed 200 words) of salient results achieved during the performance of the task order. This report is due on or before the expiration date of the task order.

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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 Division of Pre-Clinical Innovation 9800 Medical Center Drive Rockville, Maryland 20850

Acceptance may be assumed 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 total ordering period for this contract shall be 11/15/2017 through 11/14/2022.

ARTICLE F.2. DELIVERIES

a. The items specified below, and as decribed elsewhere in this contract or in individual task orders, shall be delivered F.o.b Destination as set forth in FAR Clause 52.247-35, F.o.b. DESTINATION, WITHIN COSIGNEES PREMISES (APRIL 1984), which is hereby made part of this contract.

Item Description Delivery Method Delivery Schedule

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

(2) Roster of Employees Requiring Suitability Investigations electronically to CO & COR within 14 calendar days following the effective date of the task order

(3) IT Security Plan electronically to CO within 30 calendar days following the effective date of the task order and updated annually on the anniversary date of the task order (if option periods are exercised)

(4) FIPS 199 Assessment electronically to CO within 30 calendar days following the effective date of the task order

(5) Reporting of New and Departing Employees electronically to CO & COR within 5 working days following staffing changes for positions that require suitability determinations

(6) Contractor - Employee Non-Disclosure Agreement(s) electronically to CO within 14 calendar days following the effective date of the task order; within 5 calendar days of a new employee commencing work under the task order

(7) Vulnerability Scanning Reports electronically to CO monthly, within 10 working days following the end of each month

(8) Invention Reporting Requirement - Annual Utilization Report (if option periods are exercised) electronically to CO annually on or before task order anniversary date

(9) Invention Reporting Requirement - Final Invention Statement electronically to CO on or before task order expiration

(10) Individual Subcontract Report electronically to eSRS.gov semi-annually on April 30 and October 30

(11) Summary Subcontract Report electronically to eSRS.gov annually on October 30

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Item Description Delivery Method Delivery Schedule

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

(13) Pre-meeting Status Report electronically to COR at least 24 hours prior to Team Meeting

(14) Post-meeting Status Report electronically to COR within 48 hours following Team Meeting

(15) Interim Study Reports electronically to COR within 30 days when such a request is made

(16) Final Study Report electronically to COR at least 45 days following the completion of the specified task

(17) Transition Plan electronically to CO & COR at least 45 days prior to task order expiration

(18) Summary of Task Order Salient Results electronically to CO & COR on or before task order expiration

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

Addressee Deliverable Item No.

Contracting Officer 6001 Executive Boulevard, Suite 3287 Bethesda, Maryland 20892*

1 - 9, 17, and 18

Contracting Officer's Representative email: TBD

2, 5, and 13 - 18

*Note: For delivery service or hand delivery, use: Rockville, Maryland 20852.

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

http://www.acquisition.gov/far

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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 352.242-70 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(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.

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

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b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

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

c. Competitive Ordering Process.

1. All 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 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);

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• References to evaluate past performance; and

• Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

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

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

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

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

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,500 unless the following exception(s) apply:

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

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

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

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

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

i. For orders exceeding $3,500 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

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

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

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

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-1 for 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 submitted electronically to the following approving official:

NCATS Contracting Officer NINDS R&D Contracts Management Branch NIDA Office of Acquisitions 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 Bioanalytical Method Development for Biologics

g. Contract Line Items as follows:

Line Item # Line Item Description

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

d. 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…