4.02 N0018925RZ155.pdf

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N0018925RZ155 04-Sep-2025

b. TELEPHONE NUMBER

252-619-5490

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 11 Sep 2025

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ADDENDA X ARE

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23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

N001899. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JUSTIN T. CLARK

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

1301268369

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27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

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. YOUR OFFER ON SOLICITATION

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% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

NAVSUP FLC NORFOLK PHILADELPHIA OFFICE

700 ROBBINS AVENUE, BLDG. 2B

PHILADELPHIA PA 19111-5083

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

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14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541713

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

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EDWOSB

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ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

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PREVIOUS EDITION IS NOT USABLE

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SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

N0018925RZ155

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Lite FY25-26 DBPAO PathoSeq

FFP

Genomic Differentiation of Bacterial versus Viral Diseases FOB: Destination

MILSTRIP: 1301268369

PURCHASE REQUEST NUMBER: 1301268369

PSC CD: AN42

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Lite FY25 GEIS P0022 PathoSeq

FFP

Genomic Differentiation of Bacterial versus Viral Diseases Amount FOB: Destination

MILSTRIP: 1301268369

PURCHASE REQUEST NUMBER: 1301268369

PSC CD: AN42

NET AMT

PERFORMANCE WORK STATEMENT

Performance Work Statement (PWS) for Genomic Differentiation of Bacterial and/or Viral Diseases

1.0 General Information

1.1 Introduction

NAMRU INDO PACIFIC’s mission is to monitor and characterize emerging and re-emerging infectious diseases of military and public health importance and to develop mitigation strategies against these threats in partnership with host nation, international and U.S. agencies in the Indo- Pacific Command (INDOPACOM) region. To accomplish our mission, NAMRU INDO PACIFIC contracts with the private sector for management, administration, and labor for our operations and field research.

1.2 Objectives

The objectives of this contract are to obtain services to (i) improve standardized laboratory procedures to detect biothreat agents, arboviruses, and antibiotic resistant organisms from contrived, environmental, zoonotic or patient samples, (ii) develop detailed consensus genomes for an expanded subset of regional pathogens of concern, and (iii) provide bioinformatic platform to identify novel emerging and re-emerging infectious diseases in the region in samples collected as part of the NAMRU INDO PACIFIC Biosurveillance program.

1.3 Scope of Work

The Contractor shall provide all personnel, materials, facilities, licenses, and other supplies and nonpersonal services including local agreements and assist with ethical research approvals necessary to conduct research services as defined in this PWS. This is a non-personal services award for non-severable services.

1.4. Background

NAMRU INDO PACIFIC has implemented an Armed Forces Health Surveillance Division’s Global Emerging Infections Surveillance (GEIS) program to monitor and address emerging and re-emerging pathogens in the Indo-Pacific region. This program establishes robust surveillance networks to detect and characterize novel pathogens. Through collaboration with host-nation partners, NAMRU INDO PACIFIC collects human and animal samples containing pathogens of interest for analysis using Next Generation Sequencing (NGS). Advanced sequencing bioinformatics is then employed to analyze and interpret the raw data, providing critical insights into pathogen genomics and epidemiology.

To date, NAMRU INDO PACIFIC’s collaborators supporting the surveillance networks include, but are not limited to the following:

1. Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit laboratory, Vientiane, Laos

2. Institut Pasteur du Laos, Vientiane, Laos

3. Tropical Infectious Diseases Research & Education Centre at the University Malaysia, Kuala Lumpur, Malaysia

4. Monash University, Selangor, Malaysia

5. National Defence University of Malaysia, Kuala Lumpur, Malaysia

6. University of Malaysia Sabah, Sabah, Malaysia

7. The Malaysian Armed Forces sites in Malaysia

8. Institute of Malariology, Parasitology and Entomology Quy Nhon, Hanoi, Vietnam

9. National Institute of Veterinary Research, Vietnam

10. Various locations in and around Metro Manila, Philippines

11. Hanyang University, Seoul, South Korea.

12. The National Defense Medical Center and other Taiwanese military locations in Taiwan

13. Central Public Health Laboratory, Port Moresby, Papua New Guinea

14. University of Florida, Gainesville, USA

1.5 Applicable Protocol(s), Standard Operating Procedures (SOPs), Publication(s)

1.5.1 IRB protocol HRPO.NAMRUIP.2025.0003 protocol, titled “Genomic Differentiation of

Bacterial versus Viral Diseases Across Asia and Oceania HRPO.NAMRUIP.2024.0005 protocol, titled “Phylogenetic Analysis of Korean Severe Fever and Thrombocytopenia Syndrome Virus Samples since 2013”.

1.5.2 Other protocols may be added when deemed necessary and appropriate by NAMRU

INDO PACIFIC Project Officer (PO).

2.0 Requirements

2.1 The contractor bears primary responsibility for the research.

2.2. All correspondence, deliverables, and conversations with representatives of the U.S.

Government will be in proficient English.

2.3 The contractor shall implement the study protocol(s) (1.5 above) and monitor that implementation follows approved protocol. The study protocol to be used shall be confirmed by NAMRU INDO PACIFIC PO. For any deviations that occur from approved protocol, the Contractor shall report deviation to PO and the Contracting Officer’s Representative (COR) within two business days. The contractor shall

2.3.1 Provide managerial, supervisory, administrative and logistical support to execute the protocol. In addition, the contractor shall provide the necessary personnel, materials, equipment, consumables, facilities, licenses – and all other direct and indirect costs associated with this project.

2.3.2 Assist NAMRU INDO PACIFIC to obtain regulatory and ethical approval from local internal institutional review board (IRB) at the selected study sites/locations where work is to be performed and any other required local approvals. Approvals must be obtained in writing.

2.3.3 Assist NAMRU INDO PACIFIC PO in obtaining Department of the Navy IRB approvals and Human Research Protections Program (HRPP) reviews and Command Level Administrative review (CLAR) by providing local partner human use and non-human study ethical approvals and any changes and amendments to the study protocols and study related documents for U.S. Government review as directed by the NAMRU INDO PACIFIC PO and/or the head of the NAMRU INDO PACIFIC HRPP. No samples shall be sequenced and/or data analyzed until after IRB, HRPP, and CLAR approvals and all other required approvals have been received in writing.

2.3.4 Work with local partners at each site to optimize Standard Operating Procedures (SOPs) improving detection efficiencies from sample collected for sequencing where needed for activities such as: collecting samples, transporting samples to laboratory for testing, reporting sequencing results, and storing bioinformatic data. This shall include designing and implementing all required training for local personnel.

2.3.5 Upon notification and receipt of the HRPP approval, and CLAR approval if applicable, for the research protocol from the NAMRU INDO PACIFIC PO, complete the following research activities:

2.3.5.1 Oversee the training of staff to don/doff of personal protective equipment (PPE) properly in the laboratory, perform sample-library preparation for sequencing, process serum/whole blood samples according to good clinical practices (GCPs), and onboard new SOPs as needed.

2.3.5.2 Handle all samples according to study protocol(s) in coordination with instructions for each protocol, ensuring local safety requirements and established standard laboratory operating procedures are adhered to.

2.3.5.3 Provide on-site training to laboratory staff at NAMRU INDO PACIFIC’s collaborating sites (at three sites), to (1) implement sequencing methodologies via a contamination prevention and control strategy to include genetic barcoding procedures with GCPs and quality control procedures, (2) conduct custom hybridization-enrichment, amplicon-based, and metagenomics MinION and/or Illumina-based sequencing on site, as appropriate for the site, (3) and analyze genomics data from sequencing by bioinformatics that can identify, classify and define known and new mutations in known pathogens or characterize near-neighbor novel emerging pathogens, to include protocols for the identification of viral, parasitic, and/or bacterial targets. Where prior training on sites has occurred, conduct refresher training and quality control (QC) & quality assurance (QA).

2.3.5.4 Provide an integrated system for concurrent molecular sequencing of both bacterial and/or viral diseases at each laboratory to include (1) modified molecular sequencing workflow SOPs tailored for each site’s specific laboratory setup as needed, (2) sample processing and extraction equipment of nucleic acids from human, animal, and vector respiratory and blood/serum or other biological samples as needed, (3) hybridization-enrichment and amplicon-based MinION and/or Illumina sequencing equipment and supplies, and (4) bioinformatics software and hardware. The hybridization-enrichment sequencing methodology shall contain pathogen-specific enrichment probes customized for the pathogens known or suspected to be endemic at each of the study sites, as determined in collaboration with the NAMRU INDO PACIFIC and local laboratory partners. Any equipment acquired and invoiced as cost reimbursable items by the contractor shall be U.S.

Government (USG) property and shall be returned to USG at the end of the contract. Equipment acquired shall be installed, serviced and maintained per manufacturer’s guidelines. The contractor shall provide documentation to PO and COR for the shipping, delivery, and receipt for equipment within 24-hours of delivery to the partner site(s). The contractor shall provide reports for professional installation, service, and maintenance of the equipment.

2.3.5.5 Complete NGS of at least 100 samples to characterize SARS-CoV-2, Influenza A/B, Respiratory Syncytial Virus (RSV), Dengue Virus, Plasmodium species, Adenovirus, novel human Coronaviruses, other febrile diseases, antibiotic resistant or biothreat pathogens. In addition, these results will assist in developing quality-controlled genomes of pathogens, and identifying variants and sequence polymorphisms. Sample selection for testing shall be agreed upon with NAMRU INDO PACIFIC PO and local laboratory partners.

2.3.5.6 Ensure that NAMRU INDO PACIFIC COR and PO are informed during quarterly meetings if any specific project goals cannot be achieved or if any problems are encountered to completing tasks in this PWS.

2.3.5.7 Ensure that all data records be maintained and shared with NAMRU INDO

PACIFIC PO and only among collaborating institutions. The data must be approved for presentation or publication by the NAMRU INDO PACIFIC Public Affairs Officer (PAO) including NAMRU INDO PACIFIC internal approvals. All electronic records shall be stored in secure computerized system that contains layered passwords for protection and hard copy documents in a locked and secured room.

2.3.5.8 Provide sequencing reports, Fasta files, and any other related information requested by NAMRU INDO PACIFIC PO on a quarterly basis.

2.3.5.9 Provide trip reports documenting tasks performed and subsequent sequencing results.

2.3.5.10 Provide a mid-year technical report and a final technical report.

3.0 Place of Performance

The work to be performed under this contract shall be in the United States. The locations for the bioinformatic work shall be selected by mutual agreement between the contractor and NAMRU INDO PACIFIC. Potential sites for wet-lab sequencing training/sample processing include but are not limited to those mention in Section 1.4 above. Dry-lab analyses could occur on-site and/or remotely from the USA.

4.0 Deliverables

4.1 Kickoff meeting; The Contractor shall host a kickoff meeting no later than two weeks after task order award to present research and management plans, timeline for performance of tasks, introduce key and supporting personnel, and identify any coordination and potential risks for the performance of the tasks.

4.2 All study protocols, initial and any subsequent versions, as approved by the country/local

IRB.

4.3 Quarterly Teleconference Meeting and Minutes: The Contractor shall arrange monthly meetings and provide progress updates on all aspects of the Contractors’ progress towards completing the tasks. The contractor shall generate and deliver a summary (e.g., meeting minutes) of the information shared at each teleconference meeting.

4.4 Sequencing reports, Fasta files, and other related information requested by PO; The

Contractor shall provide sequencing reports, Fasta files, and other related information requested on a quarterly basis.

4.5 Trip reports: The Contractor shall submit trip reports to detail tasks performed during the trip. Details shall include the site visited, the personnel in attendance, any trainings that were conducted, and tasks performed during the trip.

4.6 Technical Progress Reports: The Contractor shall deliver one (1) written mid-year report, due by the 10th working day after the end of six (6) months, and one (1) written final annual report due one month following the end of the period of performance. Each written report shall contain:

4.6.1 A cover page that includes the contract/task order, “contract number”, title: “[title]”, and report number (e.g., R1, July – Dec 2025).

4.6.2 Report to provide detailed description of number of events supported and contract achievements (e.g., sequencing and/or bioinformatic tasks performed, training conducted etc.), any problems identified related to the execution of the project, and any other pertinent data beneficial for interpretation of the data or successful execution of the project.

4.6.3 Reports shall be cumulative- meaning the Final report will include R1 information. All reports are the property of the U.S. Navy.

Table of deliverables

Deliverable Frequency # of Copies Medium/Format Submit To

Kickoff meeting Once within two weeks of task order award (TOA)

Verbal communication in English. Minutes in English

NAMRU

INDO

PACIFIC PO

& COR

Protocol approval and final study protocol version as approved by the country/local IRB.

Once upon approval. One Word document, written in English

PO and COR

Teleconference Progress Reports

Quarterly One Verbal communication via teleconferencing; Meeting minutes to be provided in Word document in English

PO and COR

Sequencing reports, Fasta files, and other related information requested

Quarterly One Word document, written in English

PO and COR

Trip Reports Within seven days of return from the trip

One Word document, written in English

PO and COR

R1 Report Within 6 months and 10 days of TOA

One Word document, written in English

PO and COR

Final Report Within 1 month of the end of the period of performance (POP).

One Word document, written in English

PO and COR

4. PERFORMANCE REQUIREMENTS SUMMARY

PWS

Paragraph

Performance Standard and AQL

Quality Assurance Method

Acceptance

2.3.2 Obtain Local and regulatory approvals or

approval modifications to include IRB and IACUC protocol clearance.

Monitoring by

NAMRU INDO

PACIFIC PO and

COR

Receipt of approved IRB protocol and any other required local and regulatory approvals. 0% variance.

2.3.3 Obtain HRPP and CLAR approvals. Monitoring by

PO and COR

Receipt of HRPP and CLAR approvals. 0% variance.

2.3.5.3 Provide on-site training to laboratory staff at

NAMRU INDO PACIFIC’s collaborating sites (at three sites).

Monitoring by PO and COR

0% variance. Both positive and negative performance shall be documented.

2.3.5.5 Complete next generation sequencing of 90

samples.

Monitoring by PO and COR

Deviation of 3 samples (i.e.

must sequence 87 samples).

Both positive and negative performance shall be documented.

2.3.5.8 Provide Sequencing reports, Fasta files and

any other related information requested by

NAMRU INDO PACIFIC PO

Monitoring by PO and COR

Within 5 days of due date.

Both positive and negative performance shall be documented.

2.3.5.10 Mid-year and final reports. Monitoring by

PO and COR

Within 10 days of due date.

Both positive and negative performance shall be documented.

5.0 Special Qualifications and Training

5.1 Full proficiency in English relating to correspondence, reports, manuscripts(s) and conversations with NAMRU INDO PACIFIC (e.g., during NAMRU INDO PACIFIC PO field site visits). All correspondence shall be in English. Documents in a foreign language shall be translated to English and both original and translated copies shall be delivered.

5.2 The Contractor shall ensure that all project personnel are appropriately trained for the required tasks. All team members are required to complete appropriate research training from the Collaborative Institutional Training Initiative (CITI) (http://www.citiprogram.org) or from another institution approved by NAMRU INDO PACIFIC PO. The Contractor shall provide CITI (or another institution as approved by NAMRU INDO PACIFIC PO) certificates (upon request) confirming training requirements for all Contractor and Subcontractor (if applicable) investigators and staff involved in research for this effort.

5.3 The Contractor shall ensure that all project personnel complete training on Research

Integrity, education, and misconduct. The training material shall be provided by NAMRU INDO PACIFIC. The Contractor shall provide a list of names and dates to record the completion of such training. At NAMRU INDO PACIFIC’s approval, equivalent training other than that provided by NAMRU INDO PACIFIC may be considered as acceptable.

6.0 Contractor Travel Approval

The contractor shall submit to the PO and COR a trip request authorization at least two months before anticipated travel. This is to ensure that all letters of support, coordination with visiting laboratory, local ethical approvals, IACUC and/or HRPO protocols that cover sequencing of human subject samples, animal samples, and entomological samples are submitted and approved.

7.0 Data Rights

All reports are property of the U.S. Navy. The contractor shall not release to the public any information regarding the medical research or resulting data without the review and approval of the NAMRU INDO PACIFIC PAO. The approval process may include blanket approval for some types of information releases.

The contractor shall submit to the NAMRU INDO PACIFIC PO and COR, or Contracting Officer for review and approval, in line with NAMRU INDO PACIFIC PAO requirements, prior to public disclosure any written publications or public relations materials (including proposed public announcements, flyers, posters, audiovisual materials, newspaper, advertisements, or mailed advertisements) which are targeted primarily to the scope of contract services or policies and programs of the contractor.

The U.S. Government has unlimited rights to all documents/material/reports produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be U.S. Government owned and are the property of the U.S. Government with all rights and privileges of ownership/copyright belonging exclusively to the U.S.

Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the U.S. Government shall be the sole property of the U.S. Government and may not be used for any other purpose. This right does not abrogate any other U.S. Government rights.

As proprietary owner and inventor of this pan-viral panel being tested and evaluated, PathoSeq Bio will likewise maintain rights to this data in order to be used for future proposals and patent applications.

8.0 Research Integrity

All parties agree to the definitions, protocol, and processes for research integrity as explained in BUMEDINST 6500.3B and DoD Instruction 3210.7.

9.0 Organizational Conflict of Interest

Contractor personnel performing work under this contract may receive, have access to, or participate in the development of proprietary information. The contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential organizational conflict of interest (OCI) and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the contractor from participation in subsequent contracted requirements which may be affected by the OCI.

10.0 Invoicing and Payments

All payments will be in U.S. dollars, the United States currency. Invoices shall be submitted for payment on a quarterly basis.

11.0 Protection of Human Subjects

All parties agree to the definitions, protocol, and processes for protection of human subjects in research as explained in DFARS clause 252.235-7004 (Federal Register Volume 74 Number 144, 29 July 2009) as specified below.

a) Definitions. As used in this clause--

1) Assurance of compliance means a written assurance that an institution will comply with requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103).

2) Human Research Protection Official (HRPO) means the individual designated by the head of the applicable DoD component and identified in the component's Human Research Protection Management Plan as the official who is responsible for the oversight and execution of the requirements of this clause, although some DoD components may use a different title for this position.

3) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information (32 CFR 219.102(f)). For example, this could include the use of human organs, tissue, and body fluids from individually identifiable living human subjects as well as graphic, written, or recorded information derived from individually identifiable living human subjects.

4) Institution means any public or private entity or agency (32 CFR 219.102(b)).

5) Institutional Review Board (IRB) means a board established for the purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).

6) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)).

7) Research means a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of 32 CFR Part 219, whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (32 CFR 219.102(d)).

b) The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 U.S.C. 980, and, when applicable, Food and Drug Administration policies and regulations.

c) The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met:

1) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, an assurance of compliance and IRB approval and receives notification from the Contracting Officer that the HRPO has approved the assurance as appropriate for the research under the Statement of Work and that the HRPO has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the HRPO, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of the assurance.

2) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the Contracting Officer that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor's furnished exemption determination, the HRPO retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

d) DoD staff, consultants, and advisory groups may independently review and inspect the Contractor's research and research procedures involving human subjects and based on such findings, DoD may prohibit research that presents unacceptable hazards or otherwise fails to comply with DoD procedures.

e) Failure of the Contractor to comply with the requirements of this clause will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

f) The Contractor shall include the substance of this clause, including this paragraph (f), in all subcontracts that may include research involving human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b). This clause does not apply to subcontracts that involve only the use of cadaver materials.

(End of clause)

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A Government 0002 N/A N/A N/A Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 15-SEP-2025 TO

14-SEP-2026

N/A N/A

FOB: Destination

0002 POP 15-SEP-2025 TO

14-SEP-2026

N/A N/A

FOB: Destination

CLAUSES INCORPORATED BY REFERENCE

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-7 System for Award Management NOV 2024 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-29 Federal Acquisition Supply Chain Security Act Orders--

Representation and Disclosures.

DEC 2023

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

SEP 2023

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

NOV 2023

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022

252.204-7002 Payment For Contract Line or Subline Items Not Separately Priced

APR 2020

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Antiterrorism Awareness Training for Contractors JAN 2023 252.204-7012 (Dev) Safeguarding Covered Defense Information and Cyber

Incident Reporting (DEVIATION 2024-O0013 REVISION 1)

MAY 2024

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.204-7022 Expediting Contract Closeout MAY 2021 252.204-7024 Notice on the Use of the Supplier Performance Risk System MAR 2023 252.225-7043 Antiterrorism/Force Protection Policy for Defense

Contractors Outside the United States

JUN 2015

252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JAN 2023

252.244-7000 Subcontracts for Commercial Products or Commercial Services

NOV 2023

252.247-7023 Transportation of Supplies by Sea OCT 2024

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

The Government intends to award to PathoSeq Bio, LLC. on a sole source basis. Therefore, price will be the only factor considered.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION 2025-O0003/ DEVIATION 2025-O0004) (MAR 2025)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision --

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

"Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

"Inverted domestic corporation" means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

"Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

"Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

"Predecessor" means an entity that is replaced by a successor and includes any predecessors of the predecessor.

"Reasonable inquiry" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

"Sensitive technology"--

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

"Service-disabled veteran-owned small business (SDVOSB) concern" means a small business concern—

(1)(i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs' Veterans Benefits Administration, as a service-disabled veteran.

"Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program" means an SDVOSB concern that--

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

"Service-disabled veteran-owned small business (SDVOSB) Program" means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

"Small business concern"--

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

"Small disadvantaged business concern, consistent with 13 CFR 124.1001", means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding the threshold at 13 CFR 124.104(c)(2) after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13 CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

"Subsidiary" means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

"Successor" means an entity that has replaced a predecessor by acquiring…