Notice of Intent to Sole Source.doc

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Sole Source Fixed Price (FFP) Contract Type for the Procurement of a Real Time Cell Analysis System (xCELLigence) to Agilent Technologies Inc., under Request for Quote RFQ-FDA-2021-1238228-Sole Source.

Notice of Intent to Sole Source to: Agilent Technologies Inc.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Contract Type purchase order to Agilent Technologies Inc., located at:

2850 Centerville Road

Wilmington, DE 19808

Phone: 1-800-227-9770

Fax: 302-633-8953

Email: LSCAinstrumentsales@agilent.com

Website: www.agilent.com/chem FDA has a requirement to procure a Real Time Cell Analysis System (xCELLigence) from Agilent Technologies Inc., under Request for Quote RFQ-FDA-2021-1238228, as a sole source acquisition.

Agilent Technologies Inc is the only responsible source because they are the only manufacturer of the system, which is being requested and the manufacturer does not authorize third party service providers.

This is the sole instrument with specifications that ensure a robust validation of FDA methods to test real-time changes in cell viability when exposed to complex culture conditions (multiple drug concentration, effector cell type), with high sensitivity, specificity and well-to-well precision. These standards are reached thanks to the Vendor’s patented inter-digitated gold electrode pattern technology and are required for ongoing projects in CDER/OBP.

Market research shows that Agilent Technologies Inc., with the recent acquisition of ACEA Bioscience Inc, is the sole manufacturer and distributor of the xCELLigence microelectronic biosensor system. The multiple plate system of the instrument and the possibility to place it in a regular CO2 incubator make the instrument unique in the market.

The xCELLigence system requires E-plates designed with inter-digitated gold electrode pattern a technology that is developed by and licensed to Agilent Technologies Inc (ACEA Bioscience Inc). As such, no other technical packages will fit the requirements of the acquisition. There is no duplication of cost possible with this firm-fixed price purchase, as the equipment is sent directly from the sole manufacturer of the product. No unacceptable delays in fulfilling the requirements of this request are expected. Agilent Technologies Inc is the OEM and it is necessary to have service performed by them to ensure all equipment is working together properly.

The associated NAICS Code is: 334516 - Analytical Laboratory Instrument Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Agilent Technologies Inc., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 01/30/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov Template