G-Rex500M Bioreactors For Cell Therapy Manufacturing

A SOLE SOURCE CONTRACT Title: G-Rex500M Bioreactors for Cell Therapy Manufacturing Notice ID (POTS): 26-005780 (PSC): 6515 – Medical and Surgical Instruments, Equipment, and Supplies NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing

Place of Performance: National Institutes of Health Clinical Center Bethesda, MD 20892 This Notice of Intent (NOI) is issued for informational purposes only and does not constitute a Request for Quotations (RFQ). The Government does not intend to solicit competitive quotations for this requirement. The National Institutes of Health (NIH), Clinical Center, (OALM), intends to award a sole-source, firm-fixed-price purchase order to Wilson Wolf Manufacturing LLC, 2100 Old Highway 8 NW, Saint Paul, Minnesota 55112-1802, for seven (7) cases of G‑Rex500M-CS bioreactors to support the manufacture of cell-based therapies for patients enrolled in NIH clinical trials. Required Items Product: G‑Rex500M-CS (2-Pack Box) Product Code: G285500-CS Quantity: 7 Cases

Background The Center for Cellular Engineering (CCE) uses validated G‑Rex500M bioreactors in FDA-regulated manufacturing processes for the production of cell-based therapies. Continued use of these validated bioreactors is essential to maintain manufacturing consistency, comply with approved production protocols, and ensure uninterrupted patient care. Sole Source Rationale Wilson Wolf Manufacturing LLC is the only known source capable of providing the validated G‑Rex500M bioreactors required by the Government. Substituting another product would require extensive process validation and qualification, resulting in increased costs, schedule delays, and potential interruptions to the manufacture of cell-based therapies, which could adversely affect treatment schedules for critically ill patients. Authority This acquisition is being conducted pursuant to FAR 13.106-1(b)(1), Soliciting from a Single Source. Under this authority, the

Contracting Officer may solicit from one source when only one source is reasonably available. Acquisitions under FAR Part 13 are exempt from the competition

requirements of FAR Part 6. Responses This is not a Request for Quotations. Interested parties believing they can satisfy this requirement may submit a capability statement that includes: • Company name and address • Technical capability • Proof of OEM authorization, if applicable • Relevant past performance The Government will evaluate all capability statements received; however, the decision not to compete this requirement remains solely within the Government's discretion. Submission Instructions Capability statements shall reference POTS 26-005780 and must be submitted electronically no later than July 17, 2026, at 11:00 a.m. Eastern Time (ET). Shasheshe Goolsby Team Leader Hospital and Laboratory Support Division : [email protected] Shasheshe Goolsby Contracting ., SUITE 503L (No Street Address

2) BETHESDA, MD 20892 USA to this opportunity.