NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Business model | Payment Structures

Annotations

This agreement between Fluidigm Corporation (“Fluidigm” or “Contractor”) and the U.S. National Institutes of Health (“NIH” or “Government”) was entered into on July 30, 2020. The agreement is part of NIH’s Rapid Acceleration of Diagnostics Advanced Technology Platforms (“RADx-ATP”) initiative which was created to accelerate innovation, development and commercialization for new COVID-19 diagnostics. The scope of work under the agreement includes completion of validation, approval, and production processes to deliver scaled up capacity for a viable diagnostic product.

The agreement was initiated as a Letter Contract with a fixed price of $12,151,000 to enable expedited timelines. It was converted to a definitive contract through an amendment on September 28, 2020, with a fixed price of $34,016,056. Further amendments were made in February and May 2021.

The tests manufactured under the agreement must be sold within the U.S. unless there is insufficient demand in the U.S. for the tests produced with the additional manufacturing capacity funded under the agreement. Additionally Fluidigm must provide tests to end users at a fair market rate that is consistent with objectives to increase and improve COVID-19 testing in the U.S.. Some other aspects of the agreement, including data and patent ownership are governed by the U.S. Federal Acquisition Regulation (FAR).

Provision Language

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.2. PRICES

(a) The total Firm Fixed Price (FFP) amount for this Letter Contract is $12,151,000.

Adjusted under Amendment 1

(a) The total Firm Fixed Price (FFP) amount for this contract is $34,016,056.

Adjusted under Amendment 2

SECTION I – CONTRACT CLAUSES

[…]

I.3. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

[…]

2. FAR 52.216-24 – LIMITATION OF GOVERNMENT LIABILITY (APR 1984)

(a) In performing this contract, the Contractor is not authorized to make expenditures or incur obligations exceeding $12,151,000 dollars.

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NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

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NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

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