Sol_75N92025R00003.pdf

SOLICITATION/CONTRACT 1. THIS CONTRACT IS A RATED

5. SOLICITATION TYPE2. CONTRACT NO. 4. SOLICITATION NUMBER

PAGE OF PAGES

7. ISSUED BY CODE 8. THIS ACQUISITION IS

BIDDER/OFFEROR TO COMPLETE BLOCKS 11, 13, 15, 21, 22, & 27

RATING

ORDER UNDER DPAS (15 CFR 700)

3. AWARD/

EFFECTIVE DATE ISSUE DATE

6. SOLICITATION

UNRESTRICTED OR SET ASIDE:

SMALL BUSINESS

SIZE STANDARD:

9. (AGENCY USE)

NO COLLECT CALLS

10. ITEMS TO BE PURCHASED (BRIEF DESCRIPTION)

SUPPLIES SERVICES

11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN

CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A DIFFERENT

PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE CONTRACTOR

AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE ITEMS SOLICITED

HEREIN AND TO ACCEPT ANY RESULTING CONTRACT SUBJECT TO THE TERMS

AND CONDITIONS STATED HEREIN.

CODE 12. ADMINISTERED BY

13. CONTRACTOR FACILITY 14. PAYMENT WILL BE MADE BY CODE CODE

OFFEROR CODE

TELEPHONE NO.

UNIQUE ENTITY IDENTIFER

CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:

15. PROMPT PAYMENT DISCOUNT 16. AUTHORITY FOR USING OTHER

THAN FULL AND OPEN COMPETITION

10 U.S.C. 2304 41 U.S.C. 253

NEGOTIATED

(RFP)

SEALED BIDS

(IFB)

1 175

11/22/2024

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

541715

% FOR:X

x x

NHLBI

National Gene Vector Biorepository

1,000

75N92025R00003

NAICS:

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS

8(A)

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOSB PROGRAM

EDWOSB

17.

ITEM NO.

18.

SCHEDULE OF SUPPLIES/SERVICES

19.

QUANTITY

20.

UNIT

21.

UNIT PRICE

22.

AMOUNT

Proposals Due: 3:00 PM EST on 1/10/2025

Questions Due: 11:00 PM ET on 12/12/2024

Proposals for furnishing the supplies and/or services in THE SCHEDULE are to be received at the email addresses specified in Attachment 1, "Packaging and Delivery of the Proposal," by 3:00

Continued ...

27. SIGNATURE OF OFFEROR/CONTACTOR 28. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

NAME AND TITLE OF SIGNER (TYPE OR PRINT) DATE SIGNED NAME OF CONTRACTING OFFICER DATE SIGNED

25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS

SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

26. AWARD OF CONTRACT: YOUR OFFER ON SOLICITATION

NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS

OR CHANGES WHICH ARE SET FORTH HEREIN, IS

ACCEPTED AS TO ITEMS:

23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT

(FOR GOVERNMENT USE ONLY)

ETHAN J. MUELLER

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 1447 (REV. 8/2016)

Prescribed by GSA - FAR (48 CFR) 53.214(d)

COPIES TO

TYPE OR PRINT NAME AND TITLE OF SIGNER

SIGNATURENAME AND ADDRESS OF FIRM (Include ZIP Code)

WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE OF ITEMS INVOLVEDWE DO

DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE OF ITEMS INVOLVED

CANNOT MEET DELIVERY REQUIREMENT

OTHER (Specify)

UNABLE TO IDENTIFY THE ITEM(S)

CANNOT COMPLY WITH SPECIFICATIONS

PAGE

NO RESPONSE FOR REASONS CHECKED

175 2 OF

DATE AND LOCAL TIME

AFFIX

STAMP

HERE

TO:

FROM:

SOLICITATION NO.

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

75N92025R00003

STANDARD FORM 1447 (REV. 8/2016) BACK

(A)

ITEM NO.

(B)

SUPPLIES/SERVICES

(C)

QUANTITY

(D)

UNIT

(E)

UNIT PRICE

(F)

AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 175

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N92025R00003

PM EST on 1/10/2025.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE

CONTRACTING OFFICER OR THEIR DESIGNEE AT THE

PLACE AND TIME SPECIFIED FOR THE OFFICE OF

ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND

HANDLED IN ACCORDANCE WITH HHSAR Clause

352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L. OF THIS SOLICITATION.

IF YOU INTEND TO SUBMIT A PROPOSAL, PLEASE

COMPLETE AND SUBMIT THE PROPOSAL INTENT RESPONSE

FORM, ATTACHMENT 12, by 12/16/2024 via email to ethan.mueller@nih.gov and turners@nhlbi.nih.gov.

Offeror must be registered in the System for

Award Management (SAM) prior to contract award.

For information contact Ethan Mueller at ethan.mueller@nih.gov and Stacy Turner at turners@nhlbi.nih.gov.

NSN 7540-01-218-4386 STANDARD FORM 1447 (REV. 8/2016)

PAGE OF PAGES

7. ISSUED BY CODE 8. THIS ACQUISITION IS

BIDDER/OFFEROR TO COMPLETE BLOCKS 11, 13, 15, 21, 22, & 27

RATING

ORDER UNDER DPAS (15 CFR 700)

3. AWARD/

EFFECTIVE DATE ISSUE DATE

6. SOLICITATION

UNRESTRICTED OR SET ASIDE:

SMALL BUSINESS

SIZE STANDARD:

9. (AGENCY USE)

NO COLLECT CALLS

10. ITEMS TO BE PURCHASED (BRIEF DESCRIPTION)

SUPPLIES SERVICES

11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN

CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A DIFFERENT

PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE CONTRACTOR

AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE ITEMS SOLICITED

HEREIN AND TO ACCEPT ANY RESULTING CONTRACT SUBJECT TO THE TERMS

AND CONDITIONS STATED HEREIN.

CODE 12. ADMINISTERED BY

13. CONTRACTOR FACILITY 14. PAYMENT WILL BE MADE BY CODE CODE

OFFEROR CODE

TELEPHONE NO.

UNIQUE ENTITY IDENTIFER

CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:

15. PROMPT PAYMENT DISCOUNT 16. AUTHORITY FOR USING OTHER

THAN FULL AND OPEN COMPETITION

10 U.S.C. 2304 41 U.S.C. 253

NEGOTIATED

(RFP)

SEALED BIDS

(IFB)

1 171

11/22/2024

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

541715

% FOR:X

x x

NHLBI

National Gene Vector Biorepository

1,000

75N92025R00003

NAICS:

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS

8(A)

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOSB PROGRAM

EDWOSB

17.

ITEM NO.

18.

SCHEDULE OF SUPPLIES/SERVICES

19.

QUANTITY

20.

UNIT

21.

UNIT PRICE

22.

AMOUNT

Proposals Due: 3:00 PM EST on 1/10/2025

Questions Due: 11:00 PM ET on 12/12/2024

Proposals for furnishing the supplies and/or services in THE SCHEDULE are to be received at the email addresses specified in Attachment 1, "Packaging and Delivery of the Proposal," by 3:00

Continued ...

27. SIGNATURE OF OFFEROR/CONTACTOR 28. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

NAME AND TITLE OF SIGNER (TYPE OR PRINT) DATE SIGNED NAME OF CONTRACTING OFFICER DATE SIGNED

25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS

SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

26. AWARD OF CONTRACT: YOUR OFFER ON SOLICITATION

NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS

OR CHANGES WHICH ARE SET FORTH HEREIN, IS

ACCEPTED AS TO ITEMS:

23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT

(FOR GOVERNMENT USE ONLY)

ETHAN J. MUELLER

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 1447 (REV. 8/2016)

WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE OF ITEMS INVOLVEDWE DO

DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE OF ITEMS INVOLVED

CANNOT MEET DELIVERY REQUIREMENT

OTHER (Specify)

UNABLE TO IDENTIFY THE ITEM(S)

CANNOT COMPLY WITH SPECIFICATIONS

PAGE

NO RESPONSE FOR REASONS CHECKED

171 2 OF

DATE AND LOCAL TIME

AFFIX

STAMP

HERE

TO:

FROM:

SOLICITATION NO.

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

(B)

SUPPLIES/SERVICES

(C)

QUANTITY

(D)

UNIT

(E)

UNIT PRICE

(F)

AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 171

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N92025R00003

PM EST on 1/10/2025.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE

CONTRACTING OFFICER OR THEIR DESIGNEE AT THE

PLACE AND TIME SPECIFIED FOR THE OFFICE OF

ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND

HANDLED IN ACCORDANCE WITH HHSAR Clause

352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L. OF THIS SOLICITATION.

IF YOU INTEND TO SUBMIT A PROPOSAL, PLEASE

COMPLETE AND SUBMIT THE PROPOSAL INTENT RESPONSE

FORM, ATTACHMENT 12, by 12/16/2024 via email to ethan.mueller@nih.gov and turners@nhlbi.nih.gov.

Offeror must be registered in the System for

Award Management (SAM) prior to contract award.

For information contact Ethan Mueller at ethan.mueller@nih.gov and Stacy Turner at turners@nhlbi.nih.gov.

PAGE OF PAGES

7. ISSUED BY CODE 8. THIS ACQUISITION IS

BIDDER/OFFEROR TO COMPLETE BLOCKS 11, 13, 15, 21, 22, & 27

RATING

ORDER UNDER DPAS (15 CFR 700)

3. AWARD/

EFFECTIVE DATE ISSUE DATE

6. SOLICITATION

UNRESTRICTED OR SET ASIDE:

SMALL BUSINESS

SIZE STANDARD:

9. (AGENCY USE)

NO COLLECT CALLS

10. ITEMS TO BE PURCHASED (BRIEF DESCRIPTION)

SUPPLIES SERVICES

11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN

CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A DIFFERENT

PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE CONTRACTOR

AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE ITEMS SOLICITED

HEREIN AND TO ACCEPT ANY RESULTING CONTRACT SUBJECT TO THE TERMS

AND CONDITIONS STATED HEREIN.

CODE 12. ADMINISTERED BY

13. CONTRACTOR FACILITY 14. PAYMENT WILL BE MADE BY CODE CODE

OFFEROR CODE

TELEPHONE NO.

UNIQUE ENTITY IDENTIFER

CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:

15. PROMPT PAYMENT DISCOUNT 16. AUTHORITY FOR USING OTHER

THAN FULL AND OPEN COMPETITION

10 U.S.C. 2304 41 U.S.C. 253

NEGOTIATED

(RFP)

SEALED BIDS

(IFB)

1 171

11/22/2024

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

541715

% FOR:X

x x

NHLBI

National Gene Vector Biorepository

1,000

75N92025R00003

NAICS:

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS

8(A)

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOSB PROGRAM

EDWOSB

17.

ITEM NO.

18.

SCHEDULE OF SUPPLIES/SERVICES

19.

QUANTITY

20.

UNIT

21.

UNIT PRICE

22.

AMOUNT

Proposals Due: 3:00 PM EST on 1/10/2025

Questions Due: 11:00 PM ET on 12/12/2024

Proposals for furnishing the supplies and/or services in THE SCHEDULE are to be received at the email addresses specified in Attachment 1, "Packaging and Delivery of the Proposal," by 3:00

Continued ...

27. SIGNATURE OF OFFEROR/CONTACTOR 28. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

NAME AND TITLE OF SIGNER (TYPE OR PRINT) DATE SIGNED NAME OF CONTRACTING OFFICER DATE SIGNED

25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS

SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

26. AWARD OF CONTRACT: YOUR OFFER ON SOLICITATION

NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS

OR CHANGES WHICH ARE SET FORTH HEREIN, IS

ACCEPTED AS TO ITEMS:

23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT

(FOR GOVERNMENT USE ONLY)

ETHAN J. MUELLER

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 1447 (REV. 8/2016)

WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE OF ITEMS INVOLVEDWE DO

DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE OF ITEMS INVOLVED

CANNOT MEET DELIVERY REQUIREMENT

OTHER (Specify)

UNABLE TO IDENTIFY THE ITEM(S)

CANNOT COMPLY WITH SPECIFICATIONS

PAGE

NO RESPONSE FOR REASONS CHECKED

171 2 OF

DATE AND LOCAL TIME

AFFIX

STAMP

HERE

TO:

FROM:

SOLICITATION NO.

National Institutes of Health National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511

NHLBI

(B)

SUPPLIES/SERVICES

(C)

QUANTITY

(D)

UNIT

(E)

UNIT PRICE

(F)

AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 171

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N92025R00003

PM EST on 1/10/2025.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE

CONTRACTING OFFICER OR THEIR DESIGNEE AT THE

PLACE AND TIME SPECIFIED FOR THE OFFICE OF

ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND

HANDLED IN ACCORDANCE WITH HHSAR Clause

352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L. OF THIS SOLICITATION.

IF YOU INTEND TO SUBMIT A PROPOSAL, PLEASE

COMPLETE AND SUBMIT THE PROPOSAL INTENT RESPONSE

FORM, ATTACHMENT 12, by 12/16/2024 via email to ethan.mueller@nih.gov and turners@nhlbi.nih.gov.

Offeror must be registered in the System for

Award Management (SAM) prior to contract award.

For information contact Ethan Mueller at ethan.mueller@nih.gov and Stacy Turner at turners@nhlbi.nih.gov.

SECTION A - Solicitation/Contract Form SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. PROVISIONS APPLICABLE TO DIRECT COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging and Marking SECTION E - Inspection and Acceptance SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. TASK ORDER PROCEDURE

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. GOVERNMENT PROPERTY

7. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. CERTIFICATE OF CONFIDENTIALITY

3. HUMAN MATERIALS

4. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

5. PUBLIC HEALTH SURVEILLANCE EXCLUSION

6. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

7. DATA SHARING IN LARGE-SCALE HUMAN OR NON-HUMAN GENOMIC DATA

8. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-

FUNDED RESEARCH

9. ACKNOWLEDGEMENT OF FEDERAL FUNDING

10. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

11. MULTIPLE PRINCIPAL INVESTIGATORS

12. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

13. GUN CONTROL

14. OPTION PROVISION

15. SUBCONTRACTING PROVISIONS

16. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

17. PUBLICATION AND PUBLICITY

18. NHLBI POLICY FOR DATA SHARING FROM CLINICAL TRIALS AND EPIDEMIIOLOGICAL STUDIES

19. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

20. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

21. SHARING RESEARCH DATA

22. HHSAR 352.224-70 Privacy Act. (DEC 2015)

SECTION I - Contract Clauses

19. FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems. (NOV 2021)

23. FAR 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters. (OCT 2018)

39. FAR 52.216-18 Ordering. (AUG 2020)

40. FAR 52.216-19 Order Limitations. (OCT 1995)

41. FAR 52.216-22 Indefinite Quantity. (OCT 1995)

42. FAR 52.216-25 Contract Definitization. (OCT 2010)

43. FAR 52.216-25 Contract Definitization. (OCT 2010) -Alternate I (APR 1984)

45. FAR 52.217-9 Option To Extend the Term of the Contract. (MAR 2000)

46. FAR 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. (OCT 2022)

102. HHSAR 352.224-71 Confidential Information. (DEC 2015)

105. HHSAR 352.232-71 Electronic submission of payment requests

SECTION J - List of Documents, Exhibits and Other Attachments

1. Statement of Work

2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1

3. ELECTRONIC INVOICING INSTRUCTIONS FOR NIH CONTRACTORS/VENDORS

4. Small Business Subcontracting Plan

5. Disclosure of Lobbying Activities, SF-LLL

6. Government Property - Schedule

7. Report of Government Owned, Contractor Held Property

8. Roster of Employees Requiring Suitability Investigations

9. Employee Separation Checklist

SECTION K - Representations, Certifications, and Other Statements of Bidders

1. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021)

2. FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation. (OCT 2020)

3. FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders-Representation and Disclosures. (DEC 2023)

SECTION L - Instructions,Conditions, and Notices to Bidders

1. FAR 52.204-6 Unique Entity Identifier. (OCT 2016)

2. FAR 52.204-7 System for Award Management. (OCT 2018)

3. FAR 52.204-16 Commercial and Government Entity Code Reporting. (AUG 2020)

4. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021)

5. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021) - Alternate I (OCT 1997)

6. FAR 52.215-22 Limitations on Pass-Through Charges--Identification of Subcontract Effort. (OCT 2009)

7. FAR 52.216-1 Type of Contract. (APR 1984)

8. FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer. (JUL 2013)

9. FAR 52.233-2 Service of Protest. (SEP 2006)

10. FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

11. FAR 52.252-3 Alterations in Solicitation. (APR 1984)

12. FAR 52.252-5 Authorized Deviations in Provisions. (NOV 2020)

13. HHSAR 352.215-70 Late Proposals and Revisions. (DEC 2015)

14. HHSAR 352.219-70 Mentor-Protege Program. (DEC 2015)

15. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

16. L002.02.01.02.06 Cost Proposal Instructions

SECTION M - Evaluation Factors for Award

SECTION A - Solicitation/Contract Form

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This initiative is to continue the National Gene Vector Biorepository (NGVB), which is an integral component of the National Heart, Lung and Blood Institute (NHLBI) gene therapy resource portfolio.

The objective of the National Gene Vector Biorepository (NGVB) is to provide critical resources and services to NHLBI investigators performing preclinical and clinical gene therapy research. This is accomplished by offering of support in three main areas: (1) Making available over 70 reagents (AAV and lentiviral plasmids, certified cell lines and retroviral packaging cell lines) for constructing and evaluating gene therapy vectors; (2) Providing GLP specimen archiving and storage of samples derived from preclinical pharmacology and toxicology studies, thereby enabling investigators to remain in compliance with FDA regulations; and (3) Performing testing services -- including replication competent retrovirus (RCR) and lentivirus (RCL) assays, and insertion-site analyses for mutagenic events -- that assist with meeting FDA requirements for GMP production and monitoring of gene therapy clinical trials.

The NGVB must have the capability to store biospecimens under the specialized requirements of Good Laboratory Practices (GLP) standards needed for IND-enabling work. Currently, there are over 20,000 irreplaceable tissue and blood specimens that have been archived, and the NGVB contractor will need the capability to store and maintain these and future specimens. Additionally, the NGVB performs assay development and testing for the clinical specimens under College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards, as may be required.

2. PRICES/COSTS

a. This is an Indefinite Delivery Indefinite Quantity (IDIQ) type contract as contemplated by FAR

16.504. The minimum ordering quantity under this IDIQ contract is $50,000 (minimum) and the maximum ordering quantity under this IDIQ contract is $7,000,000 (maximum). All Task Orders issued under this IDIQ contract will be cost-reimbursement and subject to FAR 52.216-7 Allowable Cost and Payment. The Government is not obligated to order any more than the minimum ordering quantity of $50,000 under this IDIQ contract.

b. The costs set forth in this ARTICLE will cover the contract period 6/18/2025 through 6/17/2030.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract and the table below.

CLIN Task Description Cost Type

Area

1One Core Administrative Tasks

Cost Reimbursement

2 Two Core Laboratory Activities

Cost Reimbursement

3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property;

12) Printing costs; and 13) Research Funding.

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.

1. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

SECTION C - Description/Specifications

STATEMENT OF WORK

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

1. REPORTING REQUIREMENTS

1. All reports shall be submitted electronically.

2. These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section- 508/index.html and at: https://www.section508.gov/create/documents , "Create Accessible Documents."

3. 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, progress reports shall be submitted electronically.

[X ] Monthly

[ ] Quarterly

[X] Semi-Annually

[ ] Annually

[ ] Annually (with a requirement for a Draft Annual Report)

[X ] Final - Upon final completion of the contract

[ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

1. 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.

c. Other Reports/Deliverables

Additional reporting requirements are identified within the Statement of Work and in Statement of Work Deliverables documents.

a. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

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.)

A. Assessment and Authorization (A&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data.

If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor must conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

A. A&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an A&A package within 30 days of contract award to the CO and/or COR. The following A&A deliverables are required to complete the A&A package.

C. System Security Plan (SSP) - due within 30 days after contract award. The SSP must comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must update the SSP at least annually thereafter.

D. Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment must be conducted by the assessor and be consistent with NIST SP 800- 53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment.

Assessments of controls can be performed by Contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

E. Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all 'high' deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

F. Plan of Actions and Milestones (POA&M) - due 30 days after contract award. The POA&M must be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All findings/weaknesses must be documented in the POA&M and remediated/mitigated from the date the weaknesses are formally identified and documented by the timelines below:

• Critical within 30 days;

• High within 60 days;

• Medium within 1 year; and

• Low within 1 year.

The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M must be updated at least quarterly.

G. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor must update and test the Contingency Plan at least annually.

H. E-Authentication Questionnaire - The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods must follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

I. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at:

https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx and the link to access the tool is found at: https://pdt.nbis.mil/ .

The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and 'Q' access eligibility.

[ ] Tier 5SR: Reinvestigation.

[X] Tier 5C: Sensitive - Moderate Risk (Requires suitability determination with an MBI and SF 85P)

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and 'L' access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[ ] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

J. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

An electronic template, 'Roster of Employees Requiring Suitability Investigations,' is available for contractor use at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

a. If the Contractor is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

b. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor must complete and submit the required forms within 30 days of the notification.

c. The Contractor must notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

d. All contractor and subcontractor employees must comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

e. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor must ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

f. Typically, the Government investigates personnel at no cost to the Contractor.

However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

g. The Contractor must include language similar to this 'HHS Controlled Facilities and Information Systems Security' language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

h. The Contractor must direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

i. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor must return all identification badges to the Contracting Officer or designee.

K. CONTRACT INITIATION AND EXPIRATION

a. General Security Requirements - The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Directive (2018) located at:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive- 2018.pdf . HHS EA requirements located at: https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf and NIH EA requirements are located at:

https://ocio.nih.gov/PM/Pages/EPLC.aspx .

b. System Documentation - Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals ( specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information - As part of contract closeout and at expiration of the contract, the Contractor ( and/ or any subcontractor) must provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/ or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

d. Notification - The Contractor ( and/ or any subcontractor) must notify the CO and/ or COR and system ISSO within fifteen days before an employee stops working under this contract.

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

f. The Contractor ( and/or any subcontractor) must perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation must be made available to the CO and/ or COR upon request.

g. Contractor Non- Disclosure Agreement (NDA)- Each Contractor ( and/ or any subcontractor) employee having access to non- public government information under this contract shall complete the NIH non- disclosure agreement:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA must be submitted to the Contracting Officer ( CO) and/ or CO Representative ( COR) prior to performing any work under this acquisition.

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

i. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment ( to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract. The Government includes but is not limited to the U.S. Department of Justice, U.S.

Government Accountability Office, and the HHS Office of the Inspector General (OIG).

The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

ii. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

iii. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

iv. Cooperate with inspections, audits, investigations, and reviews.

b. 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's 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.

c. Multiple Principal Investigators Leadership Plan

The Contractor must submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract.

The revised plan is subject to review and approval by the Contracting Officer.

d. NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies

The Contractor must provide data sets for the study with full documentation. The data set and documentation shall be prepared in accordance with the NHLBI's Data Set policy at:

https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies.

2. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government] 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 annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the email addresses specified in the DELIVERIES Article in SECTION F of this contract.

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

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - Packaging and Marking

A. 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 contract deliverables and services to be provided.

1. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representatives of the Contracting Officer.

c. Inspection and acceptance will be performed at: National Heart, Lung, and Blood Institute, Bethesda, MD

1. Inspect by Individual

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

2. 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.

2. FAR 52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 6/18/2025 through 6/17/2030. The period of performance of each task order will be specified in the task order.

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 Quantity Delivery Schedule

1 Manual of Procedures

(MOP) 1

Due within 30 days months of the issuance of the task order/contract.

Updated continuously and available upon request.

Request for service process and implementation

Due within 6 months of the issuance of task order/contract.

Maintained with periodic updates after that.

3 Monthly invoices 1 Monthly

4 Monthly technical narrative 1 Monthly (with invoice)

5 Semi-annual Technical Progress Report 1 Within 30 days of each 6-month period

6 Final Technical Report 1

First draft within 90 days of task order/contract expiration; Final version due 30 days before task order/contract expiration date.

7 Contractor¿s Report of Task Order Completion 1

Within 30 days of each task order expiration

8 Summary of salient results 1 Include with Final

Technical Report

9 Subcontracting Reports 1

On April 30 and October 30 and subcontract expiration.

Invention reporting requirement and Annual Invention Report

1 Annually

11 Section 508 Annual Report 1 Annually

Multiple principal investigator leadership plan (If applicable)

1 Annually, if applicable

13 Technical and business transition-out plan 1

Begin developing 90 days prior to the task order/contract expiration; Only if requested by the

COR.

¿ Submit a draft 30 days prior to the task order /contract expiration; Only if requested by the COR

14 Final report

¿ Submit a final report upon the task order/contract¿s expiration date or Upon written request from the COR.

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

Addressee Deliverable Item No Quantity Contracting Officer 1 - 14 1 electronic copy Contracting Officer's Representative 1 - 14 1 electronic copy

3. FAR 52.242-15 Stop-Work Order.