NCATS_RFP_-_3.5kg_GMP_Lot_of_sPIF_(NIHDA201800195).pdf

OMB #0990-0115

REQUEST FOR PROPOSALS (RFP) No. NIHDA201800195

Project Title: “3.5 kg GMP Lot of sPIF”

Issued by:

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

ISSUE DATE: June 5, 2018

DATE DUE: July 10, 2018, by 1:00 P.M (Eastern)

The National Center for Advancing Translational Sciences (NCATS), NIH, invites you to submit a proposal in response to RFP No. NIHDA201800195.

NCATS anticipates making a single fixed price award with an anticipated period of performance of forty-two.

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

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

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

You must furnish in writing (email is acceptable) any areas of uncertainty, which, in your opinion, require clarification to the Contracting Officer. You must submit your questions on or before June 20, 2018.

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

Proposals are to be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Please reference Attachment 1, listed in Section J, entitled “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” for instructions and further details. Note that you must create an account in the NIH electronic Contract Proposal Submission (eCPS) system/website to submit a proposal and it may take up to there (3) business days to http://www.fedbizopps.gov/ https://ecps.nih.gov/

OMB #0990-0115

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

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

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

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

The RFP does not commit the Government to pay the costs for the preparation and submission of a proposal.

The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

Any questions concerning this RFP should be directed to Jeffrey Schmidt, Contracting Officer, schmidtjr@mail.nih.gov, (301) 402-1488.

Regards, Jeffrey Schmidt, NCATS Contracting Officer NIDA Office of Acquisition mailto:schmidtjr@mail.nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition: 4960078

2. Request for Proposal (RFP) Number:

NIHDA201800195

3. Issue Date:

June 5, 2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : 3.5 kg GMP Lot of sPIF

6. ISSUED BY:

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

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in Attachment 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 1:00 PM local time on July 10, 2018. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals 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 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. Offerors must be registered in the System for Award Management (SAM) prior to contract award.

11. FOR INFORMATION CALL: Jeffrey Schmidt

PHONE: 301-402-1488

e-MAIL: schmidtjr@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

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

RFP Number : NIHDA201800195

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Past Performance Information

11. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

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1. Technical Discussions

2. Other Considerations

3. 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. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. TECHNICAL EVALUATION FACTORS

4. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Bridging Interventional Development Gaps (BrIDGs) program at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) assists researchers in advancing promising therapeutic agents through late-stage, pre-clinical development toward an Investigational New Drug (IND) application and clinical testing.

BrIDGs is currently collaborating with BioIncept to develop Synthetic Preimplantation Fact (sPIF) as a potential treatment for Graft-Versus-Host Disease (GVHD).

The purpose of this contract is for BrIDGs to acquire an additional 3.5 kg (on net peptide basis) of cGMP sPIF to allow for additional studies to be conducted, and to conduct a three year stability study of the cGMP batch.

ARTICLE B.2. PRICES

Note: Offerors should propose a payment schedule by project milestone and include the payment amount for each milestone.

a. The total fixed price of this contract is $ .

b. Upon delivery and acceptance of the services described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Service Total ($)

Total ($) =

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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 SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format and 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. Ad Hoc Team Meetings

The Contractor shall manage either face-to-face or telephone meetings on an ad hoc basis, as requested by the Government or the Contractor. The meetings are meant to keep the Government and project team appraised of the progress of the project, including any issues or problems. The Contractor's responsibilities will include but are not limited to:

• Securing either a physical location for the meeting or a suitable call in number and passcode for the relevant participants.

• Preparing an agenda of issues for discussion.

• Moderation of the meetings.

• Preparation of the meeting minutes and summarizing any action items resulting from the meeting.

2. Status Reports

The Contractor shall document the efforts performed in the completion of each task in a detailed Status Report due on or before any Ad Hoc Team Meeting. It is expected that this report will include, but not be limited to:

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

• Notable achievements.

• Issues or obstacles impeding progress and recommended solutions.

• Status of deliverables/milestones.

• Resource planning/status.

• Description of work completed and upcoming plans.

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3. Final Report

The Contractor shall submit a Final Report on or before contract expiration. The Final Report shall include, but not be limited to:

• Contractor name and address.

• Name of person submitted the report.

• Contract number.

• Report date.

• Period covered by the report.

• Comprehensive summary of work performed during the reporting period.

4. Service Contract Reporting Requirements

The Contractor shall report on services performed as required by FAR Clause 52.204-14, Service Contract Reporting Requirements (October 2016) incorporate by reference in Article I.3. ADDITIONAL CONTRACT CLAUSES of this contract and the DELIVERIES Article in SECTION F of this contract.

5. 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.

6. Certificate of Analysis

The Contractor shall submit a QA-approved GLP Certificate of Analysis (COA) that describes the results of all testing required for the final product. The COA is to be of sufficient detail to include in a regulatory (IND) submission to the US Food and Drug Administration.

7. CMC Documentation

The Contractor shall provide: (a) all QA-approved completed batch records; (b) summary of in-process sample testing; and (c) CMC report in CTD format or an update to CMC report in STD format, including data on the 3.5 kg batch. These deliverables shall be in sufficient enough detail to include in a regulatory (IND) submission to the US Food and Drug Administration--see M4Q(RQ) ICH Guidelines for reference.

8. Interim Stability Study Reports

The Contractor shall prepare interim stability reports following each sample pull. These reports shall be completed within one month of the sample pull, in CTD format, and of sufficient detail to include in a regulatory (IND) submission to the US Food and Drug Administration.

9. Final Stability Study Report

The Contractor shall prepare a final stability report following the final sample pull. This report shall be completed within one month of the final sample pull, be in CTD format, and of sufficient detail to include in a regulatory (IND) submission to the US Food and Drug Administration.

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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, 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 52.246-16, Responsibility for Supplies (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from TBD through TBD.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Delivery Method & Addressee

Delivery Schedule

(1) Ad Hoc Team Meetings electronically to COR as requested by the Government or Contractor

(2) Status Reports electronically to COR on or before Ad Hoc Team Meetings

(3) Final Report electronically to COR on or before contract expiration

(4) Service Contract Reporting Requirements electronically to sam.gov annually on October 31

(5) Subcontract Reporting Requirements electronically to esrs.gov in accordance with Article H.5 of this contract

(6) Certificate of Analysis electronically to COR within 5 months following the effective date of the contract

(7) CMC Documentation electronically to COR within 6 months following the effective date of the contract

(8) Interim Stability Study Reports electronically to COR wihtin 1 month following each sample pull

(9) Final Stability Study Report electronically to COR on or before contract expiration

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

52.242-17, Government Delay of Work (April 1984).

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:

TBD

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

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

The Government may unilaterally change its COR designation.

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

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

(End of Clause)

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

Name Title

ARTICLE G.3. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2, are 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. 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.

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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 to the following approving official:

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

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

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

NCATS CMB.

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

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

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

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

f. The Contract Title is:

"3.5 kg GMP Lot of sPIF"

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

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

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ARTICLE G.4. 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.5. GOVERNMENT PROPERTY

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

ARTICLE G.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 addition to the Final evaluation, Interim evaluation(s) will be prepared annually on the anniversary date of the contract.

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

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

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. 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. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

b. Subcontracting Reports

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

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

http://www.esrs.gov/

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October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes at the following e-mail address:

TBD

Contracting Officer

ARTICLE H.6. 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: http://oig.hhs.gov/fraud/hotline/ 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 http://oig.hhs.gov/fraud/hotline/

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PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

THE FOLLOWING ARTICLE I.1. GENERAL CLAUSE LISTING(S) WILL BE APPLICABLE TO MOST CONTRACTS

RESULTING FROM THIS RFP. HOWEVER, THE ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL

OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSE LISTING TO BE CONTAINED IN THE

CONTRACT(S) AWARDED FROM THIS RFP:

The complete listing of these clauses may be accessed at:

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors

ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE SERVICE

CONTRACT

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

Any authorized substitutions and/or modifications other than the General Clauses which will be based on the type of contract/Contractor will be determined during negotiations.

It is expected that the following substitution(s) will be made part of the resultant contract:

a. Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data--Modifications (October 2010) is added.

b. Alternate II (October 2001) of FAR Clause 52.219-9, Small Business Subcontracting Plan (November 2016) is added.

c. Alternate I (February 2002), of FAR Clause 52.232-25, Prompt Payment (Jan 2017)

d. Alternate I (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price (August 1987), is hereby deleted in its entirety and Alternate II (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price (August 1987), is substituted therefor.

e. FAR Clause 52.249-4, Termination for Convenience of the Government (Services) (Short Form) (April 1984), is deleted in its entirety and FAR Clause 52.249-2, Termination for Convenience of the Government (Fixed Price) (April 2012) is substituted therefor.

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR Clause 52.204-14, Service Contract Reporting Requirements (October 2016).

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors

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2. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations (November 2015).

3. FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (October 2014).

"(c) Waiver of evaluation preference [ ] Offeror elects to waive the evaluation preference."

4. FAR Clause 52.219-28, Post-Award Small Business Program Rerepresentation (July 2013).

5. FAR Clause 52.222-26, Equal Opportunity (September 2016).

6. FAR Clause 52.227-17, Rights in Data--Special Works (December 2007).

7. FAR Clause 52.230-2, Cost Accounting Standards (October 2015).

8. FAR Clause 52.230-6, Administration of Cost Accounting Standards (June 2010).

9. FAR Clause 52.246-25 Limitation of Liability-Services (February 1997).

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER

3) CLAUSES:

1. HHSAR Clause 352.208-70, Printing and Duplication (December 2015).

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses in full text.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June 2016)

a. Definitions . As used in this clause--

"Covered contractor information system" means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

"Federal contract information" means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

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"Information" means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

"Information system" means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

"Safeguarding" means measures or controls that are prescribed to protect information systems.

b. Safeguarding requirements and procedures.

1. The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

i. Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

ii. Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

iii. Verify and control/limit connections to and use of external information systems.

iv. Control information posted or processed on publicly accessible information systems.

v. Identify information system users, processes acting on behalf of users, or devices.

vi. Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

vii. Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

viii. Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

ix. Escort visitors and monitor visitor activity; maintain audit logs of physical access;

and control and manage physical access devices.

x. Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

xi. Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

xii. Identify, report, and correct information and information system flaws in a timely manner.

xiii. Provide protection from malicious code at appropriate locations within organizational information systems.

xiv. Update malicious code protection mechanisms when new releases are available.

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xv. Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

2. Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

c. Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

2. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July 2013)

As prescribed in 9.104-7(c), insert the following clause:

a. The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management (SAM) database at http://www.acquisition.gov.

b. As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments--

1. The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by--

i. Government personnel and authorized users performing business on behalf of the Government; or

ii. The Contractor, when viewing data on itself; and

2. The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for--

i. Past performance reviews required by subpart 42.15;

ii. Information that was entered prior to April 15, 2011; or

iii. Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

c. The Contractor will receive notification when the Government posts new information to the Contractor's record.

1. If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

http://www.acquisition.gov/

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2. The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

3. As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

d. Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

(End of clause)

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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

SOLICITATION ATTACHMENTS

Attachment No. Title Location

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

See Attached

Attachment 2: Statement of Work See Attached

Attachment 3: Section K - Representations, Certifications, and Other Statements of Offerors

See Attached

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 4: Summary of Related Activities http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/summary-related-activities.pdf

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 5: Proposal Summary and Data Record, NIH-2043 http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/NIH2043.pdf

Attachment 6: Small Business Subcontracting Plan https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

INFORMATIONAL ATTACHMENTS

Attachment No. Title Location

Attachment 7: Invoice Instructions for NIH Fixed Price Contracts NIH(RC)-2 http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/rc2_508.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/rc2_508.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/rc2_508.pdf

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PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST :

1. Go to the System for Award Management (SAM) and complete the Representations and Certifications. The SAM website may be accessed at: http://www.sam.gov ; and

2. Complete, and INCLUDE as part of your BUSINESS PROPOSAL:

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

which is included as an Attachment in Section J-LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS of this solicitation.

If you are unable to access this SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

3. FAR Clause 52.204-19 Incorporation by Reference of Representations and Certifications (December 2014).

The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) http://www.sam.gov

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SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION [FAR Provision 52.215-1 (January 2017)]

a. Definitions. As used in this provision--

"Discussions" are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal.

"In writing", "writing", or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information.

"Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award.

"Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations.

"Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day.

b. Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s).

c. Submission, modification, revision, and withdrawal of proposals.

1. Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision.

2. The first page of the proposal must show--

i. The solicitation number;

ii. The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available);

iii. A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item;

iv. Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and

v. Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office.

3. Submission, modification, revision, and withdrawal of proposals.

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(i)Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due.

(ii) (A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be…