Notice of Intent to Sole Source.doc

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Sole Source Fixed Price Contract for the procurement of a Maurice System, plus Preventative Maintenance Services (PMA) for Four (12 Months) Option Years to ProteinSimple LLC., under Request for Quote FDA-RFQ-2021-1238077.

Notice of Intent to Sole Source to: ProteinSimple LLC.

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 ProteinSimple LLC., located at:

3001 Orchard Parkway

San Jose, CA 95134 USA

Toll-Free: (888) 607-9692

Tel: (408) 510-5500

Fax: (408) 510-5599

Email: info@proteinsimple.com

(mailto:info@proteinsimple.com) FDA has a requirement to procure a Maurice System, plus Preventative Maintenance Services (PMA) for Four (12 Months) Option Years to ProteinSimple LLC., under Request for Quote FDA-RFQ-2021-1238077, as a sole source acquisition.

ProteinSimple LLC., is the only responsible source because they are the only manufacturer of the “Maurice System”, which is being requested. Maurice System is only provided by the manufacturer and the manufacturer does not authorize third party service providers.

FDA wishes to purchase a Maurice by Protein Simple because it is the only compact user-friendly instrument that utilizes interchangeable cartridges for characterizing and quantifying the isoelectric point and purity of therapeutic proteins. Maurice will allow for the characterization and quantification of the isoelectric point or purity of drug products and experimental therapeutic proteins produced in-house.

ProteinSimple LLC., is the OEM and it is necessary to have service performed by them to ensure all equipment is working together properly. The Maurice C. system from ProteinSimple expands on ProteinSimple’s proprietary icIEF technology for iCE™ system. Additionally, FDA is not aware of any other cartridge-based instruments that can perform both ic-IEF and c-SDS, which is the critical feature that will address the particular research challenges of FDA. ProteinSimple LLC., is the one responsible source and no other supplies or services can satisfy agency requirements.

The NAICS Code for this procurement is: 34516 Laboratory analytical instruments (except optical) 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 ProteinSimple LLC., 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 01/20/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov Template