THERAKOS CELLEX Photopheresis System Procedural Kits

THERAKOS® CELLEX® Photopheresis SYSTEM Procedural Kits Product Service Code:

6505-Drugs and Biologicals NAICS Code:

325413- In-Vitro Diagnostic Substance Manufacturing Place of Performance: National Institutes of Health Clinical Center 10 Center Drive Bethesda, MD 20892 POTS: 24-011158 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 Contracts intends to award a one-time fixed price contract to Therakos Inc. on a sole source basis to procure THERAKOS® CELLEX® Photopheresis SYSTEM Procedural Kits, CLXUSA for extracorporeal photopheresis therapy to patients post stem-cell transplantation on the existing government owned THERAKOS® CELLEX® Photopheresis System Instrument.

Cellex USA Kits are required for emergent Extracorporeal Photopheresis (ECP) procedures for Clinical Center patients. Only one known vendor has been identified for the purchase of 5 cases of the THERAKOS® CELLEX®Procedural Kits-CLXUSA. Therokos Inc. is the sole registered trademark holder and manufacturer of the required product. If the THERAKOS® CELLEX®Procedural Kits are not procured, it would negatively impact patient care.

Patients would be at an increased risk for post-stem-cell transplant complications, and infection. There are no other procedural kits compatible with the THERAKOS® CELLEX® Photopheresis System Instrument.

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: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Comments: Comments to this announcement, referencing this posting number on the email subject line, 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 July 29, 2024, (Noon 12:00 pm EST) and time marked in this notice.