Master Alliance Provisions Guide (MAPGuide)

NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

  • Business model | Regulatory strategy

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.3. ADVANCE UNDERSTANDINGS

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(g) Successful performance under this contract requires the Contractor obtain and maintain an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy us on all FDA correspondence related to the project, including email communications to and from the FDA. The FDA EUA services provided under this Letter Contract constitute a commercial service to detect SARS-CoV-2.