Therakos Inc. Cellex® Photopheresis System Procedural Kits

Title Therakos Inc. Cellex® Photopheresis System Procedural Kits Product Service Code:

6640 NAICS Code:

325413 Place of Performance:

Bethesda, MD 20892 USA POTS: 25-004077 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) intends to issue a firm-fixed-price purchase order for five (5) cases of Cellex® Photopheresis System Procedural Kits, needed for emergent Extracorporeal Photopheresis procedures in patient care, to Therakos Inc., located in Hazelwood, Missouri 63042-2301.

The Department of Transfusion Medicine requests the procurement of Cellex® Photopheresis System Procedural Kits for emergent Extracorporeal Photopheresis (ECP) procedures for Clinical Center patients. Therakos Inc. is the original equipment manufacturer of the Cellex® Photopheresis System Procedural Kits equipment and its supplies. These kits are required for rare photopheresis procedures that are not conducted routinely.

The need for these procedures is determined by the treatment plans, which vary based on the patient’s condition and are communicated by the primary care team as needed. The kits are not stocked in advance but ordered on an as-needed basis to ensure they do not expire. The below items are required for this request: Product Code/Description/Quantity CLXUSA (140-mL bowl)/ Cellex® Photopheresis System Procedural Kits /5 Cases Therakos Inc is the sole manufacturer of the Cellex® System Procedural Kits.

These kits must be used in conjunction with the Therakos Cellex® System currently located within the Department of Transfusion Medicine. There are no other known sources that can provide these kits.

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. The total dollar value of this requirement shall not exceed the Simplified Acquisition Threshold (SAT) $250,000.00. Interested parties may identify their interest and submit capability statements 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 Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by March 7, 2025 6:30AM EST.

Please send your capability statements ONLY. This IS NOT a request for quotation.