NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Equitable Access | Affordable pricing

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.3. ADVANCE UNDERSTANDINGS

[…]

(h) Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the cost per test is competitive with the current market price. The Contractor must comply with applicable federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent with the objective to increase and improve testing in the United States and its territories.

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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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