Notice of Intent to Sole Source.pdf

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CDER-2024-123845 Acquisition of O-link system and reagents
Solicitation number
FDA-RFQ-CDER-2024-123845
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This document is a Notice of Intent to Sole Source for the procurement of an Olink system and reagents, under Request for Quote FDA-RFQ-CDER-2024-123845. The Food and Drug Administration (FDA) intends to award a sole source fixed-price purchase order to Olink Proteomics AB Inc. for the Olink system and related reagents, as Olink is the sole manufacturer and distributor of this proprietary technology. The requirement is for an Olink Signature instrument, accessories, and reagents for the detection of cytokines in cell-based assays. The associated NAICS code is 424210-Drugs and Druggists' Sundries Merchant Wholesaler. Responses from any parties capable of meeting the requirement must be submitted by 12:00 p.m. EST on 05/15/2023. The government anticipates awarding the sole source purchase order to Olink Proteomics AB Inc. within 15 days of the notice, unless another organization demonstrates the capability to meet the requirement.

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Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of CDER-2024-123845 Acquisition of O-link system and reagents, Sole Source, under Request for Quote FDA-RFQ-CDER- 2024-123845.

Notice of Intent to Sole Source to: Alomone Labs 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) Purchase Order Type to Olink Proteomics AB Inc., located at:

Olink Proteomics AB Inc Salagatan 16F, www.olink.com Olink Proteomics, Dag Hammarskjölds väg 52B Uppsala Science Park, SE-751 83 Uppsala, Sweden Phone: +46 (0)18 444 39 70, info@olink.com, Reg no: 559046-8632

FDA requires O-link system and reagents, Sole Source, under Request for Quote FDA-RFQ-CDER- 2024-123845. This is a request for the procurement of O-link system and reagents, Sole Source. and the items are solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. This is an order for the purchase of an Olink Signature, related accessories and reagents for the detection of cytokines in a multiplex format from cell-based assays.

This vendor is the sole manufacturer and supplier for this instrument. This is a proprietary technology at which this instrument and related materials are the center.

The associated NAICS 424210-Drugs and Druggists' Sundries Merchant Wholesaler. Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation.

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 Olink Proteomics AB 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 05/15/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov

File details come from the government source that posted it. Updated .