INTRODUCTION This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: CELLGENIX USA 1 Nh AVE Portsmouth, NH 03801-2904 United States NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard 1250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-05 March 10, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: CellGenix USA/ Various CellGenix cytokines for X-SCID. 2. Background Information: The Center Cellular Engineering (CCE) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. 3. Purpose or Objective: To procure the selected CellGenix Cytokines in the preparation for treatment of patient with X-Linked Severe Deficient Severe Combined Immunodeficiency (X-SCID) enrolled in FDA approved clinical protocols. IND is only allowing cytokines from this manufacturer to be used, prohibit the substitution of any reagent/process named in the original protocol submissions. 4. The Vendor will supply reagents as needed in a timely manner no later than 8/4/21. The reagents include but not are not limited to those listed below: Description Quantity GMP FLT-3L, 50 ug (Cat.# 001015-050) 9 GMP SCF, 50 ug (Cat.# 001018-050) 9 GMP TPO, 50 ug (Cat.# 001017-050) 9 CellGenix GMP rh IL-7 (Cat. # 001010-050) 6 CellGenix GMP rh IL-21 (Cat. # 001019-050) 4 CellGenix GMP rh IL-15 (Cat. #001013-050) 4 The Vendor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. Delivery Schedule: 8/4/21 SHIP TO: Katy Burkert CCE/CC/NIH Bldg 10, Room 3C720 9000 Rockville Pike Bethesda, MD 20892 -The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Government Responsibilities The CCE shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients. It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by CellGenix USA. With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, and the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 15th, 2021, 11:00 AM Eastern time and must reference solicitation number 21-010644. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at
[email protected]. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."