Bio-Rad Lab., Inc./ 10x Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex, validation kit and calibration kit.

INTRODUCTION 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). This is 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), 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: BIO-RAD LABORATORIES, INC. 2000 ALFRED NOBEL DR HERCULES, CA, 94547-1804 USA 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: Bio-Rad Lab., Inc./ 10x Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex, validation kit and calibration kit. 2. Background Information: The Center for Cell Engineering (CCE), part of Clinical Center is involved in the study of characterizing human immune response with CAR-T cells treated patient. We will profile cytokines and chemokines and regulators of extracellular mediators to investigate the immune biomarker changes during the CAR-T manufacturing to provide the guidance for our clinical sample producing and develop the lot release assays. We are here requesting the purchase of Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex from Bio-Rad are able to detect up to 48 biomarkers simultaneously at one sample. The Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex from Bio-Rad, which is compatible with Bio-Plex Magpix instrument that we have in our lab. The Bio-Rad is the only one vendor that provides these reagent kit. 3. Purpose or Objective: To procure the Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex for clinical CAR-T potency testing, throughout development and manufacturing as a standardized panel of genes for optimizing methods, developing manufacturing acceptance criteria as well as understanding the host influences beyond manufacturing. 4. The Vendor will supply reagents as needed in a timely manner for the period of performance, which is 8/1/22 - 7/30/23. The reagents include but not are not limited to those listed below: Description Quantity Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex (Cat.# 12007283) 10 Bio-Plex Calibration Kit (Cat. #171203060) 1 Bio-Plex Validation Kit (Cat. #171203001) 1 Freight/handling 2 The Vendor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. Delivery Schedule These reagents will be shipped overnight delivery Monday through Thursday to: The Center for Cellular Engineering (CCE) has a standing order of scheduled delivery agreement with Bio-Rad. The company shall comply by sending the materials per the standing order schedule. These reagents and kits will be shipped overnight delivery Monday through Thursday to: Attention: Dr. Ping Jin Center for Cellular Engineering(CCE), NIH/CC 9000 Rocville Pike Bldg. 10/ Rm. 2C328 Bethesda, MD 20892-1288 The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Requirements The vendor will provide full report documenting the safe transport of cryopreserved patient cells from outside institutions to the NIH. The Vendor will ensure that temperature and other parameters are maintained during the shipment of reagents and kits. This will ensure the desired outcomes in the center for cellular engineering clinical research protocols. Government Responsibilities The PACT Lab 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 Bio-Rad Inc. 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 June 30th, 2022, 9:00 AM Eastern time and must reference solicitation number 22-009800. Responses may be submitted electronically to Ms. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."