Inactive

Title: NOI Cytiva Preventative Maintenance, Software Updates and System Upgrades NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance (Average Annual Receipts $34 Million) PSC... Title: NOI Cytiva Preventative Maintenance, Software Updates and System Upgrades NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance (Average Annual Receipts $34 Million) PSC/FSC: J066 Place of Performance: Bethesda, MD 20892 POTS: 23-009684 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), Office of Purchasing and Contracting on behalf of the Center for Cellular Engineering Department intends to award a firm fixed price contract to Cytiva-Global Life Sciences Solutions USA LLC located in Marlborough, MA 01752-3078 on a sole source basis to perform preventative maintenance services, software updates and system upgrades. List of Equipment Sepax C-Pro Cell Processing System - Serial Number 14100 Sepax C-Pro Cell Processing System - Serial Number 29264741 The Center for Cellular Engineering manufactures cell-based therapies for patients who either no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). The Center for Cellular Engineering (CCE) has a requirement for a contractor to perform preventative maintenance services and software upgrades and updates on two Cytiva devices. The software upgrade is required as the old operating system is no longer supported by Microsoft with security upgrades. The engineering upgrades are needed to bring the three devices into compliance with FDA mandates. Global Life Sciences (Cytiva) is the manufacturer and sole supplier of this equipment and the only known source capable of performing these services on this highly specialized equipment. Global Life Sciences (Cytiva) provides authorized and trained service technicians capable of performing these services. FDA mandates that all repairs and maintenance are carried out by qualified technicians in accordance with manufacture specifications. Cytiva-Global Life Sciences Solutions USA LLC is the only source that can provide trained technicians qualified to perform the required services and system updates and upgrades. 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@nihg.gov by the due date and time marked in this notice.