NanoString/ 64 of XT_HS_CAR-T Panel CSO reagent kits.

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).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), 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:

NanoString Technologies, Inc.
530 Fairview Ave N
Seattle, WA, 98109-5553

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) 2005-100, August 22, 2018. 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: NanoString/ 64 of XT_HS_CAR-T Panel CSO 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. 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.
nCounter CAR-T Characterization Panel, XT_HS_CAR-T Panel_CSO used for nCounter MAX Analysis System. Measure eight essential components of CAR-T biology with 780 human genes. It can help streamline the CAR-T manufacturing workflow and potentially reduce vein to vein time. The nCounter CAR-T Characterization Panel can be used 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.

3. Purpose or Objective: CCE uses the nCounter® XT_HS_CAR-T Panel_CSO reagent kit to profile gene expression of clinical CAR T cells. The nCounter CAR-T Characterization Panel can be used 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.

Key Features and Benefits:
• Measure eight essential components of CAR-T biology with 780 human genes
• Optimize CAR-T method development
• Create manufacturing acceptance criteria
• Streamline the CAR-T manufacturing workflow

4. Delivery: approximately 4-8 weeks A.R.O.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1. The contractor will supply the specified amount of materials

2. Shelf Life-Minimum - shelf life of any unopened disposable shall be at least 3 years unless otherwise agreed to from date of delivery at the DLM CCE.
3. The materials to be procured are:
nCounter CAR-T Characterization Panel, XT_HS_CAR-T Panel_CSO reagent kits Catalog # 115000343, Quantity of 64
4. The Contractor shall provide technical support for these materials and their performance
Characteristics at no cost to the government.

Period of Performance
The performance for these product is:

Base years: 06/01/2019-05/31/2020

Option year 1: 06/01/2020-05/31/2021

Delivery Schedule:
Shipped 32 QTY annually.

These medical supplies/equipment will be shipped delivery Monday through Thursday 8:00 AM to 4:00PM to:
NIH/CC/DTM/Center Cellular Engineering
10 Center Drive
Bldg. 10/ Rm. 3N317B
Bethesda, MD 20892-1288
Attention: Ping Jin or RongYe Shi

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

1. The Center Cellular Engineering shall use the reagents in accordance with manufacturer's package inserts and approved IND/IDE uses if applicable.

2. The NIH CC Center Cellular Engineering 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 Veterans Healthcare Supply Solutions. 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, 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 May 23rd, 2019, 10:00 AM Eastern time and must reference solicitation number 19-008558. Responses may be submitted electronically to Mrs. 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."

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