NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Equitable access | Ensuring continuity

Structural Questions

Under what circumstances can the continuity rights be exercised? (What are the conditions precedent?)
What is an appropriate scope for the continuity rights? What are the rights and obligations of each party?
Should related license grants vest upon execution of the agreement, or at a later stage in development?
Should there be an escrow requirement?
Should there be any restrictions on the developer’s ability to transfer project-related intellectual property to a third party?

Summary of Approaches

Under what circumstances can the continuity rights be exercised? (What are the conditions precedent?) What is an appropriate scope for the continuity rights? What are the rights and obligations of each party?
- The government has “march-in rights” under this agreement through reference to FAR Clause 52.227-11. March-in rights are further governed through the U.S. Code (35 U.S.C. 203) under which the government can require Fluidigm to grant a licence to a Subject Invention under the agreement to a third party, on reasonable terms and in any field of use, if the government determines that:
  - (i) Fluidigm has not or will not achieve Practical Application of the Subject Invention;
  - (ii) the license is required to alleviate health or safety needs;
  - (iii) the license is required to meet public use requirements; or
  - (iv) Fluidigm has breached a Preference for United States Industry requirement.
- Notification and appeals procedures apply prior to exercise of the march-in rights under the Code of Federal Regulations (37 CFR 401.6).

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.

[…]

(p) FAR Clause 52.227-11 Patent Rights-Ownership by the Contractor (May 2014).

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Master Alliance Provisions Guide (MAPGuide)

NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

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NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Provision Language

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