Scalable Transfection System

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.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK) intends to award a purchase order without providing for full and open competition to Maxcyte, 22 First field Road, Gaithersburg, MD 20878 for the purchase of MaxCyte ATX® Scalable Transfection System, Research, Clinical and Commercial Use and Software Licenses (including standard protocols).

The purchase request is for a MaxCyte ATX in order to allow manipulation of the expression of proteins that function as transcription factors. The purchase request includes the MaxCyte ATX and processing assemblies for its use. Justification for the purchase of the MaxCyte ATX is based on its broad range of functionality as an electroporation apparatus, coupled with exceptionally high efficiency and low toxicity, at a fraction of the time taken by other similar machines. The results are comparable to stable cell lines and the assays can be developed and conducted in just a fraction of the time. The MaxCyte ATX is the only technology platform to offer these features and capabilities. Other unique features necessitating a sole source quotation for this device are as follows: Proprietary Electroporation Process that offers Seamless ScalabilityTM from 50,000 cells in seconds, up to 700,000 cells in 30 seconds; computerized electroporation process is computerized generating an extensive set of real-time performance data (encrypted) for subsequent analysis and record-keeping; proprietary Cell-Line Specific electroporation protocols that require no optimization; a closed, sterile system that is cGMP compliant, ISO 9000 Certified and CE Marking Certified; ability to load simultaneous multiple agents, including DNA, RNA, small molecules, etc...; ability to transfect multiple cell types with high efficiency and viability, including primary cells, stem cells, & cell lines; uses only one chemically defined buffer for all transfections that contains no added biological agents; allows for transfected cells to be cryopreserved for future use; the Processing Assemblies are made only of USP Class IV grade materials (approved for blood contact). It also has a relatively small footprint.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 334516 with a Size Standard 1000.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2005-95 effective 19 Jan 2017. 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 ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY
This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

Place of Performance
National Institutes of Health
9000 Rockville Pike
Bethesda MD 20892
United States

DESCRIPTION OF REQUIREMENT

1 Each ATX-100
MaxCyte ATX® Scalable Transfection System, Research, Clinical and Commercial Use and Software Licenses (including standard protocols)

4 Each SOC1
OC-100 Processing Assemblies (100 ul volume), Lot of 10 Units, including 100 mL Electroporation Buffer
*MaxCyte processing assemblies have a guaranteed shelf-life of 3 years from date of manufacture

4 Each SOC4
OC-400 Processing Assemblies (400 ul volume), Lot of 10 Units, including 100 mL Electroporation Buffer
*MaxCyte processing assemblies have a guaranteed shelf-life of 3 years from date of manufacture

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: certification to provide OEM service and parts, unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), 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 to this notice shall be submitted electronically by 11:00 AM Eastern Standard Time, on Wednesday, January 9, 2019 to verne.griffin@nih.gov and must reference Sol # 75N94019Q00011 in the subject line.

Assessment of Capability
Technically Capability to provide required certification from the OEM.

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