NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Protecting & sharing information | Publication of Results

Summary of Approaches

What information are the parties required or permitted to publish?
- Through incorporation of FAR Clause 52.227-14, Fluidigm can release, distribute or publish data first generated under the agreement unless it is prohibited by law or another clause in the agreement.
- Through incorporation of HHSAR Clause 352.227-70, Fluidigm can publish the results of its work. It must notify NIH of each article submitted for publication and provide copies of each publication.

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 I – CONTRACT CLAUSES

Selections will be made by the Contracting Officer during definitization.

I.1. ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

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

[…]

(q) FAR Clause 52.227-14, Rights in Data – General (May 2014).

Added under Amendment 1

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER CLAUSES)

a. HHSAR Clause 352.227-70, Publications and Publicity

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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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