Updated Requirements Document Two Nanopore GridION.docx

CFSAN Statement of Work (SOW)

Software License and Device Warranty for Two Nanopore GridION instruments

1. Purpose

The purpose of this requirement is to acquire a Software License and Device warranty for two (2) Nanopore Technology’s GridION instruments, device ID GXB02111 and device ID GXB02130. The GridION is used to support FDA’s Next Generation Sequencing (NGS) business needs for genomic data collection and analysis.

2. Background The efforts are required to support FDA’s Next Generation Sequencing (NGS) business needs for genomic data collection and analysis. Researchers within the CFSANs Office of Applied Research and Safety Assessment are participating in an initiative to build a database of foodborne beneficial microbes and pathogens based on Next Generation Whole Genome Sequencing methods. Also, part of the OARSA’s interest is in understanding the transcriptome of these microbes. As part of the initiatives, the laboratories have purchased instrumentation for sequencing. The software license and device warranty for the instrumentation is necessary for the instrument to function accurately. The sequences from the pathogenic bacteria will be included into the Genometrakr network. The GenomeTrakr network is the first distributed network of laboratories to utilize whole genome sequencing for pathogen identification. It consists of public health and university laboratories that collect and share genomic and geographic data from foodborne pathogens. The sequences from the beneficial microbes will be made publicly available in NCBI. OARSA research teams using the sequencers will be providing sequences to this database which is also being populated by scientists through the already established network.

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:

•Software updates upon release, which will not require a physical visit to the facility.

•Hardware updates on release, which also will not require a physical visit to the facility. If the instrument becomes faulty, the vendor’s tech team will work to troubleshoot the issue remotely. If the problem cannot be resolved, the vendor will send a replacement device. Without a valid license, the vendor will not be able to properly troubleshoot any issues or replace the devices if needed.

•Return and Replace policy

4. Scope

· Purchase of software license and device warranty renewal that will cover the two Nanopore GridION instruments (device ID’s above) for one year. These instruments were purchased in FY19, under PO 75F40119P10651. The total cost will be $25,000 total, $12,500 for each instrument. The software license and device warranty renewal were also done in FY21 under PO 75F40121P00634, and in FY23 under PO 75F40123P00077.

5. Specific Tasks

5.1 Task 1 - The task at hand is to purchase two Software Licenses and Device warranties for two (2) Nanopore Technology’s GridION machines, Device IDs GXB02111 and ID GXB02130 that were purchased in FY19, under PO 75F40119P10651.

a. Software and hardware updates shall fall under this agreement (Software License and Device Warranty). Upon notice by the Customer, the vendor shall use reasonable efforts to fix errors in the functioning of the Nanopore technology 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. The agreement shall be effective from the date of the award, for one year.

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 reasonable efforts to fix errors in the functioning of the Nanopore 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 on www.nanoporetech.com if made available without additional license fees.

Project Milestones/Completion Dates (Estimates and as applicable)

Milestones Projected Completion Date

6. Deliverables

· Vendor shall deliver Software License and Device warranty for two (2) 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 CFSAN Office of Applied Research and Safety Assessment.

Deliverable Table

Deliverable Title

Recipient

Isha Patel

7. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) No Government-furnished property will be provided to the Contractor.

8. Contractor Provided Special Material Requirements The required material will be available online for the customer to access as and when needed.

9. Security If needed, Government will provide escort of the service engineer to install the software and hardware updates on the Nanopore GridION instruments, in the case that the update cannot be done virtually. The engineer will not be provided access to any material that involves Non-Public positions and involves the lowest degree of adverse impact on the efficiency of the Agency. This position does not require a badge or access to FDA’s network.

10. Travel If travel is required, the contractor will cover the expenses.

11. Other Considerations None to disclose.

12. Place of Performance

The task of installation will be performed at FDA, MOD1 8301 Muirkirk Road Laurel, MD 20708. POC Isha Patel. . Work shall be conducted Monday through Friday, excluding federal holidays.

13. 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:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day 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.

14. Period of Performance

9/28/2024 through 9/27/2025. If possible, Program requests to include option years for the device warranty and license renewal so that the option can be exercised if funding is available. Program would like to request at least three (3) option years, if the vendor would do so, and if allowable by the FDA Contracts Office.