Notice of Intent to Sole Source.pdf

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Sole Source of Physio-Mimix CN Bio Organ Chip Equipment System, Plus Four (12 Months) Option Years of Preventative Maintenance Agreement (PMA) to CN-Bio Innovations Inc., under Request for Quote FDA-SS-RFQ-2020-1233532.

Notice of Intent to Sole Source – CN-Bio Innovations 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 firm-fixed price purchase order to CN-Bio Innovations Inc., located at:

332 Cambridge Science Park, Milton Cambridge, Cambridgeshire

CB4 0WN, UK

DUNS: 211102169

ATTN: Vaishnavi Manoharan vaishnavi.manoharan@cnbio.com

The purpose of this acquisition is to procurement of a Physio-Mimix CN Bio Organ Chip Equipment System, Plus Four (12 Months) Option Years of Preventative Maintenance Agreement (PMA) to CN- Bio Innovations Inc., as a sole source acquisition to CN-Bio Innovations Inc., under Request for Quote

FDA-SS-RFQ-2020-1233532.

CN-Bio Innovations Inc., is the only responsible source because they are the only manufacturer of the “Physio-Mimix CN Bio Organ Chip Equipment System”.

This Physio-Mimix CN Bio Organ Chip Equipment System is only provided by the manufacturer.

There are no known distributors and the manufacturer does not authorize third party service providers.

In a Sole Source letter dated 08/17/2020, sent to FDA, CN-Bio Innovations Inc., confirmed that this company “is the original manufacturer of the Physio-Mimix product range and is the only vendor of this equipment, and currently does not sell the equipment through any distribution in the USA and only CN-Bio Innovations Inc., qualified technicians can service the instrumentation”.

The NAICS code 541511 Custom Computer Program Services.

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

Template mailto:vaishnavi.manoharan@cnbio.com mailto:vaishnavi.manoharan@cnbio.com 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 CN-Bio Innovations 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 08/28/2020. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov