Title: Notice of Intent to Sole Source with Nanostring Technologies, Inc. - nCounter MAX Analysis System Preventative Maintenance Service

• Product Service Code: J066- Maintenance /repair/rebuild Of Equipment- Instruments and Laboratory Equipment
• NAICS Code: 811210- Electronic and Precision Equipment Repair and
• Maintenance (Small Business Size Standard: $34M Average Annual Receipts)
• Place of Performance: Bethesda, MD 20892

POTS: 23-007231

Description:

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH), Clinical Center (CC), Purchasing and Contracts Office on behalf of the Center for Cellular Engineering (CCE) intends to sole source to Nanostring Technologies, Inc. located in Seattle, Washington 98109-5553 for a base period and for option years for a nCounter Max Analysis System Preventative Maintenance Service Agreement.

The Center for Cellular Engineering (CCE) has a requirement for Preventative Maintenance Services for government owned equipment, Counter Max Analysis System. The nCounter MAX Analysis System is used to specifically identify differential gene expression in CAR-T panel and other panels for clinical cell products in fast and fully automated manners, test gene modification efficiencies, and quality control cell selection methods.

Nanostring Technologies, Inc. is the original equipment manufacturer and the only source capable of supplying compatible the clinically approved platform for reagents, kits, and the respective instruments that may be used for patient care testing for differential gene expression analysis and tracking immunotherapy efficiency and monitoring side effects on clinical and research cellular products. The preventive maintenance is required to be compliant with manufacturer specifications and recommendations and with the Food and Drug Administration (FDA) 21 CFR 211.67. The nCounter MAX analysis system is unique which identifies specific cell populations and modifications to guide and improve cell product administrated to the NIH’s patients. This instrument is needed to generate data that is required for providing guidance to improve immunotherapy efficiency of the cellular therapy product.

Period of Performance:

Base Year: 09/20/2023-09/19/2024

Option Year One: 09/20/2024-09/19/2025

Option Year Two: 09/20/2025-09/19/2026

Option Year Three: 09/20/2026-09/19/2027

Option Year Four: 09/20/2027-09/19/2028

The contractor shall supply all parts and supplies necessary to perform the preventative maintenance services and calibrations.

The contractor shall provide a full-service plan which shall include:

• Annual Preventive Maintenance (PM) and Calibration
• 90 days warranty from PM date
• Full coverage for all spare parts, labor and travel
• Software updates
• Software upgrades
• Hot-line response within 1 business day, technical support available
• On-site response within 3 business day

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri@nih.gov by the due date and time marked in this notice.

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