HFP-2025-129425 SOW.pdf

HFP-2025-129425

RFQ No.: 75F40125Q00248

Software License and Device Warranty for GridION instruments

Statement of Work (SOW)

1. Purpose

The purpose of this requirement is to acquire a software license and device warranty for four (4) Oxford Nanopore Technologies GridION instruments: Device IDs GXB02111, GXB02130, GXB03574, and GXB02077. These instruments support the FDA’s Next

Generation Sequencing (NGS) operations for genomic data collection and analysis.

2. Background

This effort supports the FDA’s NGS initiatives within the Office of Applied

Microbiology and Technology (OAMT). OAMT researchers are building a database of foodborne pathogens and beneficial microbes using Whole Genome Sequencing (WGS) methods. These efforts contribute to:

• The GenomeTrakr network, the first distributed system for WGS-based pathogen identification, aggregating data from public health and academic labs.

• The NCBI public database, where sequences from beneficial microbes are shared.

The GridION instruments are essential to this research, and their continued optimal operation relies on valid software licenses and device warranties, which enable critical updates and vendor support.

3. Objectives

The software license and device warranty award ensure that the instruments are performing optimally by providing the latest up-to-date hardware and software. The award guarantees that Oxford Nanopore Technologies support services are delivered during the award period. This includes:

• Remote software and hardware updates

• Remote diagnostics and technical support

• Replacement devices if issues cannot be resolved remotely

• Return and replace coverage

4. Specific Tasks

Task 1 – Procure Software Licenses and Device Warranties

Purchase and activate four (4) software licenses and warranties for the following

GridION instruments:

1. Device ID GXB02111

2. Device ID GXB02130

3. Device ID GXB03574

4. Device ID GXB02077

The contractor shall:

a. Software and hardware updates shall fall under this agreement (Software

License and Device Warranty). Upon notice by the Customer, the vendor shall use commercially reasonable efforts to fix errors in the functioning of certain software that cause it to function other than in accordance with its applicable functional specification included in the Software Documentation. If the problem cannot be solved, a replacement device will be sent. There aren’t any physical deliverables associated with the Software License and Device

Warranty (SL & DW) renewal.

b. Maintain the agreement for a 12-month term from the date of award.

c. The vendor shall offer Software Support. The vendor shall provide support for the software made available for use with the GridION. The vendor shall use commercially reasonable efforts to fix errors in the functioning of certain

Software that cause it to function other than in accordance with its applicable functional specification included in the Software documentation.

d. The vendor shall offer software updates. Customer shall install patches or new releases released by the vendor within one (1) month after release, if not otherwise installed or updated automatically. Customer shall not interfere or otherwise prevent automatic updates of patches or new releases of the

Software and shall cooperate in installing patches or new releases of Software.

Customer shall agree to install the most current release of the Software within sixty (60) days of its first availability onwww.nanoporetech.com if made available without additional license fees.

Project Milestones/Completion Dates (Estimates and as applicable)

Task

Number

Work

Milestones

Projected

Completion

Date

1 Software License and Device warranty for four (4) Nanopore

Technology’s GridION instruments s/n GXB02111, s/n

GXB02130, GXB03574 and GXB02077

9/28/2025

5. Deliverables

Nanopore Technologies must deliver Software License and Device warranty for four (4)

Nanopore Technology’s GridION instruments. Any parts required for the service shall be brought by an Oxford Nanopore Technologies certified engineer at the time of the visit or sent to OAMT.

Deliverable Task Quantity Frequency Format Due Date Recipient

Software License & Device

Warranty for 4 GridION

Instruments

1 1 Annual Online 09/28/2025 Isha Patel

Parts required for service will be provided by a certified Oxford Nanopore Technologies engineer or shipped directly to OAMT.

6. Contractor-Provided Special Materials

All materials (e.g., license access) will be available online for FDA use as needed.

7. Place of Performance

MOD1 Location (Devices GXB02111 and GXB02130):

FDA MOD1

8301 Muirkirk Road

Laurel, MD 20708

POC: Isha Patel, 240-402-3594

CPK1 Location (Devices GXB03574 and GXB02077):

5001 Campus Drive

College Park, MD 20740

POC: Padmini Ramachandran, 301-796-0610

Work will be conducted Monday through Friday, excluding Federal holidays.

8. Period of Performance

The period of performance includes a base year of 12 months, with four (4) 12-month option periods.

9. Contract Type

This requirement will be awarded as a Firm Fixed Price (FFP) contract.

10. Security

If onsite service is required, FDA will escort the service engineer. No access will be granted to FDA systems or sensitive data. A badge is not required.

11. Travel

If travel is required, the contractor shall bear all associated costs.

12. Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are

Federal Holidays or on any other day designated as a Federal holiday for the

Washington, DC area:

Date Day of Week Holiday Name

January 1 Wednesday New Year’s Day

January 20 Monday Birthday of Martin Luther King, Jr.

January 20 Monday Inauguration Day

February 17 Monday Washington’s Birthday (aka Presidents Day)

May 26 Monday Memorial Day

June 19 Thursday Juneteenth National Independence Day

July 4 Friday Independence Day https://www.federalholidays.net/usa/holiday/new-years-day.html https://www.federalholidays.net/usa/holiday/martin-luther-king-jr-day.html https://www.federalholidays.net/usa/holiday/inauguration-day.html https://www.federalholidays.net/usa/holiday/washingtons-birthday.html https://www.federalholidays.net/usa/holiday/memorial-day.html https://www.federalholidays.net/usa/holiday/juneteenth.html https://www.federalholidays.net/usa/holiday/independence-day.html

September 1 Monday Labor Day

October 13 Monday Columbus Day

November 11 Tuesday Veterans Day

November 27 Thursday Thanksgiving Day

December 25 Thursday Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the

Contract).

In the event the Federal Government is closed by order of the President of the United

States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure (e.g. applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the

Contracting Officer.

13. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person with authority to act as agent of the

Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFP; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award.

The Government will not reimburse the Contractor for any work not authorized by the

Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the

Contractor's technical progress, including the surveillance and assessment https://www.federalholidays.net/usa/holiday/labor-day.html https://www.federalholidays.net/usa/holiday/columbus-day.html https://www.federalholidays.net/usa/holiday/veterans-day.html https://www.federalholidays.net/usa/holiday/thanksgiving-day.html https://www.federalholidays.net/usa/holiday/christmas-day.html of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the contract and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

14. Roles & Contact Information

• Contract Specialist (CS):

Erika Crawford

Email: Erika.Crawford@fda.hhs.gov

• Contracting Officer’s Representative (COR):

Kristen McLaughlin

Email: Kristen.McLaughlin@fda.hhs.gov

• Technical Point of Contact (TPOC):

Isha Patel

Email: Isha.Patel@fda.hhs.gov