Draft 75N93023R00013 with Attachment.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692 as amended

2. Request for Proposal (RFP) Number:

75N93023R00013

3. Issue Date:

February 16, 2024

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : FUNCTIONAL OMICS CORE LABORATORY

6. ISSUED BY:

Office of Acquisitions (OA) Division of Extramural Activities (DEA) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Department of Health and Human Services (DHHS) 5601 Fishers Lane, ROOM 3D10, MSC 9821 Bethesda, MD 20892-9821

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," 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 the Proposal," until 3:00 pm EST local time on May 17, 2024. 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 THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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

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

11. FOR INFORMATION CALL: Karen Telphia

PHONE: 240-669-2960

e-MAIL: karen.telphia@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Offerors are strongly encouraged to submit questions regarding the solicitation by no later than 3:00 pm EST on April 17, 2024 so that we can provide timely responses before proposals are due.

https://www.sam.gov/SAM/

RFP Number : 75N93023R00013

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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. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. CONCEPT REVIEW

j. PREPARATION COSTS

k. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

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10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. ROTC Access and Federal Military Recruiting on Campus

13. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

14. Past Performance Information

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

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. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

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

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to conduct, develop, acquire, improve, implement, validate, analyze and report data from state-of-the-art high-throughput functional omics assays and approaches (e.g., genomics, epigenomics, transcriptomics, proteomics) for comprehensive characterization of immune responses in samples from in vivo or in vitro studies investigating simian immunodeficiency virus (SIV), simian-human immunodeficiency virus (SHIV), HIV and other infectious diseases. The assays will primarily focus on samples from animal models for HIV, however analysis of samples from human clinical trials with HIV or other infectious diseases maybe included to evaluate immunogenicity and efficacy of vaccines or other prevention strategies.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

c.

Estimated Cost

Base Period

Option Period(s):

Total

[Base Period and Option(s)]

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

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ARTICLE B.4. 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. The following Advance Understandings will be included in any resultant contract:

a. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

1. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

a. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

b. Fringe Benefits - Cite rate and amount

c. Overhead - Cite rate and amount

d. Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

e. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

f. Consultant Fees - Identify individuals and amounts.

g. Subcontracts - Attach subcontractor invoice(s).

h. Equipment - Cite authorization and amount.

i. G&A - Cite rate and amount.

j. Total Cost

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

2. The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract.

b. Confidentiality of Information and Control of Materials

The Contractor shall guarantee strict confidentiality of the information/data that 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.

Certain information and data provided to the Contractor shall require confidential treatment. Information to be treated confidentially may pertain to proprietary information provided by the AIDS vaccine product and reagent developers and vaccine trial investigators. All information supplied by the COR should be assumed to be proprietary unless specifically identified as non-confidential in writing by the COR.

All materials such as samples and reagents obtained or generated as a result of this contract shall be restricted to contract-related studies, and shall not be released to any other investigators without approval of the COR.

Proprietary data confidentiality will be protected by an Advance Understanding to be included in the contract as follows:

1. The Contractor agrees that the use of materials provided to the Contractor by or through the Government for studies performed under this project shall be restricted to contract-related projects and shall not be released to any other party without approval of the COR.

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2. Because the Contractor may be utilizing and evaluating materials provided to the Government by third parties, including vaccine product and reagent developers and vaccine trial investigators, it is essential to include provisions that will protect the rights of these third parties. Therefore, the Contractor agrees that manuscripts/abstracts based on data/information generated under this contract will be submitted for review, comment, and identification of proprietary information by the collaborating vaccine product and reagent developers and vaccine trial investigators at least fifteen (15) days before manuscripts are submitted for publication or results are submitted for oral presentation. The Contractor also agrees, upon request by a collaborating third party, to delay any proposed public disclosure for up to thirty (30) additional days as necessary to prepare and file a patent application.

3. Contract support shall be acknowledged in all such publications. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information.

Publications must comply with NIH Public Access Policy (http://publicaccess.nih.gov/policy.htm). The NIAID will use its best efforts to assist and expedite the review process by the Third-Party Suppliers wherever possible.

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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, dated July 10, 2023, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Deliverable Submission (eRDS) Site, available as the following website: 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: https://www.hhs.gov/web/section-508/ index.html and at: https://www.section508.gov/create/documents, "Create Accessible Documents."

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that one electronic version of the following reports will be required for this contract identified below:

[X] Monthly [ ] Quarterly [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI) https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents

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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: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/ default/files/web/508/contracting/technology/section_508_annual_report.doc.

3. Other Reports and Deliverables required by the Contract and Statement of Work

Item Reports Recipients Delivery Schedule

1. Monthly Progress Report Submitted via NIAID eRDS to COR and CO

The first report is due on or before May 30, 2025.

Thereafter, each report is due on or before the 30

2. Semi-Annual Progress Report

Submitted via NIAID eRDS to COR and CO

The first report is due on or before November 30, 2025. Thereafter, each report is due on/before the 30th of the month following each 6-month period. Monthly and Progress Report will not be submitted the month the Semi-Annual Progress Report is due.

3. Annual Progress Report Submitted via NIAID eRDS to COR and CO

The first report is due on or before May 30, 2026. Thereafter, each report is due on/before the 30th of the month following each anniversary date of the contract.

Monthly, and Semi-Annual Progress Reports will not be submitted the month Annual Progress Report is due.

4. Annual Utilization Report Submitted via NIAID eRDS to COR and CO

Due on or before the 30 of the month following each anniversary date of the contract.

https://www.ecfr.gov/current/title-45/part-94 https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

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Item Reports Recipients Delivery Schedule

5. Final Invention Statement Submitted via NIAID eRDS to COR and CO

Due on or before expiration date of the contract.

6. All reports and documentation including invention disclosure report, the confirmatory license, and the government support certification

Submitted to OPERA As Required by FAR Clause 52.227-11.

7. Draft Final Report Submitted via NIAID eRDS to COR and CO

Draft Final Report is due 60 calendar days prior to the expiration date of the contract.

8. Final Report Submitted via NIAID eRDS to COR and CO

Final Report is due on or before the 30 calendar days prior to completion date of the contract.

9. Summary of Salient Results

Submitted via NIAID eRDS to COR and CO

Due on or before the expiration date of the contract.

10. Section 508 Report Submitted via NIAID eRDS to COR and CO

Due on or before the

30th of the month following each anniversary date of the contract.

11. Quarterly Budget Report Submitted via NIAID eRDS to COR and CO

Each report is due on/ before the 30th of each month following each reporting period.

12. Assay data and results of each set of samples received by the Contractor

1 electronic copy to COR and COR for designee for deposition into SVEU Study Database

Within 30 calendar days after completion of each study.

13. SOPs for all services and assays to be conducted under this contract

Submitted via NIAID eRDS to COR and CO

Within 30 calendar days after initiation of the contract.

14. Initial Transition Plan Submitted via NIAID eRDS to COR and CO

Within 10 calendar days after initiation of the contract.

15. Draft Final Transition Plan Submitted via NIAID eRDS to COR and CO

Due on or before 6 months prior to the expiration date of the contract.

16. Final Transition Plan Submitted via NIAID eRDS to COR and CO

Due on or before 2 months prior to the expiration date of the contract.

17. Specimens or reagents, including those received by the Contractor from the COR or designated Contractor. All electronic listing of accurate and

Submitted to COR and/ or designee to a location specified by the COR.

On or before the expiration date of the contract.

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Item Reports Recipients Delivery Schedule updated information on specimen inventory, including activities of the Contractor, Computerized data files, original data and any necessary information related thereto. SOPs.

Government-owned equipment and property.

18. Annual Site Visit Report Submitted via NIAID eRDS to COR and CO

Within 10 calendar days of completion of each annual site visit.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before June 1st, 2025. Thereafter, reports shall be due on or before the 30 Calendar day following the reporting period.] The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer Office of Acquisition Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room 3C40 Bethesda, Maryland 20892- 9821

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

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

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

The Contractor will be expected to ship to specified domestic and international destinations under appropriate shipping conditions and in accordance with International Air Transport Association (IATA)/International Civil Aviation Organization (ICAO) dangerous goods shipping regulations and other relevant shipping regulations (https:// www.iata.org/publications/dgr/pages/index.aspx). The specific shipping/packaging requirements are provided in the Statement of Work. 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 usable and acceptable condition.

https://www.iata.org/publications/dgr/pages/index.aspx https://www.iata.org/publications/dgr/pages/index.aspx

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SECTION E - INSPECTION AND ACCEPTANCE

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

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

c. Inspection and acceptance will be performed at:

Preclinical Research and Development Branch Vaccine Research Program Divisions of AIDS National Institute of Allergy and Infectious Diseases National Institute of Health Department of Health and Human Services 5601 Fishers Lane Bethesda, MD 20892

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 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from May 1, 2025 through April 30, 2026.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option 1 (Year 2) May 1, 2026-April 2027

Option 2 (Year 3) May 1, 2027-April 2028

Option 3 (Year 4) May 1, 2028-April 2029

Option 4 (Year 5) May 1, 2029-April 2030

Option 6 (Year 6) May 1, 2030-April 2031

Option 7 (Year 7) May 1, 2031-April 2032

ARTICLE F.2. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor Hours . The labor Hours Include vacation, holiday, and sick leave. These labor Hours Include subcontractor labor Hours .

It is estimated that the labor Hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Professional Other Professional Support

Totals

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer Hours than the minimum specified number of direct labor Hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of Hours by which the number of direct labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

https://www.acquisition.gov/?q=browsefar

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

To be named at the time of award.

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

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

The Government may unilaterally change its COR designation.

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

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

(End of clause).

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

Name Title

To be specified prior to award

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for NIH Cost- Reimbursement Type Contracts 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.

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1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

1. Until the Contract has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

2. Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name- TBD Email Address-

Contracting Officer Representative

Name- TBD Email Address-

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

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

3. 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 National Institutes of Allergy and Infectious Diseases .

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI 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 UEI 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. [Note: A VIN is assigned to new contracts awarded on or after June 4, https://www.ipp.gov https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, 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:

Functional Omics Core Laboratory

g. Contract Line Items as follows:

Line Item # Line It Description

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

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

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

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

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Nov 2021).

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. INDIRECT COST RATES

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

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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

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BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

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 as follows 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 thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

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

b. Electronic Access to Contractor Performance Evaluations

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

https://www.cpars.gov

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be found at: https://oamp.od.nih.gov/ sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property- Appendix%20Q.pdf https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://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. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable:

1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103, "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102, "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https:// www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at https://grants.nih.gov/policy/reproducibility/ index.htm, including FAQs and a General Policy Overview.

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

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from any NIH-funded or conducted research, supported in whole or in part with direct costs from NIH regardless of NIH funding mechanism. NIH defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications that result from the publishing and peer review process, and which should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the award/ support period, whichever comes first. The PMC archive will permanently preserve and retain these manuscripts for use by the public, health care providers, educators, scientists, and NIH. NIH Policy directs electronic submissions to the NIH/NLM/PMC: https://www.ncbi.nlm.nih.gov/pmc/.

Additional information is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html and https:// publicaccess.nih.gov/.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://grants.nih.gov/policy/reproducibility/index.htm https://grants.nih.gov/policy/reproducibility/index.htm https://www.ncbi.nlm.nih.gov/pmc/ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html https://publicaccess.nih.gov/ https://publicaccess.nih.gov/

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ARTICLE H.6. 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.7. GUN CONTROL

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

ARTICLE H.8. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract and FAR 52.217-7, Option for Increase Quantity-Separately Priced Line, set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST- Option Article in SECTION B of this contract.

ARTICLE H.9. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror( s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

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

1. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https:// osdbu.hhs.gov. The offeror shall follow the instructions outlined in the SBCX Industry Guide at: https:// oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

2. The official point of receipt for determining timely submission of an offeror's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

3. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late in accordance with subparagraph (c)

(3) of FAR Clause 52.215-1, Instructions to Offeror-Competition Acquisition. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday

- Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the presented client support hours of operation for assistance.

https://osdbu.hhs.gov https://osdbu.hhs.gov https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j mailto:client.support@apexlogic.com

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5. Individual Subcontract Reports (ISR)

The Contractor must submit the following Subcontracting reports electronically via the Subcontracting Reporting System (eSRS) at https://www.esrs.gov/.

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

6. Summary Subcontract Report (SSR) Regardless of the effective date of this contract, the Summary Subcontract Report must be submitted annually on the following date for the entire life of this contract:

October 30th

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

To be specified prior to the award Contracting Officer

ARTICLE H.10. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE

HHSAR 352.239-73 (December 2015).

a. Section 508 of the Rehabilitation Act of 1973 ( 29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information ( EIT) Accessibility Standards ( 36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

b. Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.