Illumina, Inc/ NextSeq 500/550 v2.5 sequencing reagent kits.

INTRODUCTIONThis 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:Illumina, Inc.5200 Illumina WaySan Diego, California92122-4616, United StatesNORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 325413 with a Size Standard 1,250. REGULATORY AUTHORITYThe resultant contract will include all applicable provisions and clauses in effect through the Federal

Acquisition Circular (FAC) 2022-04 January 30, 2022. 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 AUTHORITYThis 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 INFORMATION1. Title: Illumina, Inc/ NextSeq 500/550 v2.5 sequencing reagent kits.2. Background Information:  The Center for Cellular Engineering (CCE) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported, including CAR-T cells and iPSCs. Also, regarding Institute research support it:  1)Develops biologics collection and manufacturing processes to support clinical trials, 2) Collects, manufactures and distribute blood components for in vitro research use, 3) Collaboration in the design, planning, execution and data analysis of clinical studies, 4) Collects and manufactures specialized cellular products to support clinical trials and, 5) Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization.In addition to continuing bulk RNA-seq and TCR seq analysis on CAR-T cell and other engineered cells, We have been starting to investigate differential gene expression and protein expression simultaneously at single cell level by facilitating the reaction on BD Rhapsody single cell analysis system, including Rhapsody scanner and Rhapsody express that we just adopted recently from BD biosciences, to help us  develop  clinical lot release more efficiency to streamline workflow of CAR T cells manufacturing at CCE and clinical research as well. 3. Purpose or Objective: Purchase of NextSeq 500/550 v2.5 sequencing reagent kits.4. Period of Performance:   7/30/22 to 7/29/23.5. CONTRACTOR REQUIREMENTSScope of Work:This is a standing order with multi-type of sequencing kits and reagents as all those kits and reagents with very short shelf life. In order to keep study going forward and save funding.The contractor will ship sufficient reagents and kits following the scheduled delivery dates unless otherwise agreed to early release by requester.Shelf life-Minimum: Shelf life of any unopened sequencing reagents shall be at least 3 months unless otherwise agreed to from date of delivery at the CCE, PACT laboratory. Shelf life of library generation kits shall be at least 6 months from date of delivery to CCE.This standing order may include reagents and kits but not limited to those listed below.The Contractor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government.ITEMS:QTY. 36 - NextSeq 500/550 High Output Kit v2.5 (150 Cycles) Cat. #20024907QTY.10 - NextSeq 500/550 High Output Kit v2.5 (300 Cycles) Cat. #20024908QTY. 16 – PhiX Control v3 Cat. # FC-110-30016. Inspections and Acceptance RequirementsDr. Ping Jin from the CCE, NIH/CC will•           Receive reagents and kits under the appropriate conditions•           That the packaging integrity is not compromised•           That all ordered materials have arrived•           That serial numbers match the documentation•           Any discrepancies are reported to One Lambda7. Supply 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 protocols8. Logistical Requirements:The Center for Cellular Engineering (CCE) has a standing order of scheduled delivery agreement with Illumina. 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        10 Center Drive        Bldg. 10/ Rm. 2C328        Bethesda, MD 20892-1288The 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.Deliveries are Monday through Thursday 9 AM to 5:30 PM and must be signed for.•           All packaging must be intact and a packing slip.9. Government ResponsibilitiesThe Center for Cellular Engineering (CCE) shall use the reagents and disposables in accordance with manufacturer’s package inserts and approved IND/IDE uses if applicable.The NIH CC Center for Cellular Engineering (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) DETERMINATIONThis 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 Illumina, Inc.  With the continuation of using the same supplies 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 STATEMENTThis 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 20th, 2022, 9:00 AM Eastern time and must reference solicitation number 22-009719. 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."