Company: MYGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000899923-25-000019
Chunk: 25

Company: MYRIAD GENETICS INC
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 25
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 MyChoice HRD testing.We pay CMCC a royalty based on net sales of our MyChoice HRD test.License runs for the term of the CMCC agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the CMCC agreement.Institut Curie and INSERM (INSERM)Exclusive world-wide right to certain rights of INSERM in intellectual property relating to our MyChoice HRD testing.We pay INSERM a royalty based on net sales of our MyChoice HRD test.License runs for the term of the INSERM agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the INSERM agreement.Illumina, Inc.Non-exclusive license to certain rights held by or licensed to Illumina to intellectual property relating to non-invasive prenatal screening and the Prequel test.We pay Illumina a royalty based on the volume of Prequel testing administered by us.License runs for the term of the Illumina agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the Illumina agreement.Eurobio Scientific SA (Eurobio)Exclusive license to certain rights of Eurobio in intellectual property relating to our EndoPredict assay.We pay Eurobio a royalty based on net sales of our EndoPredict test.License runs for the term of the Eurobio agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the Eurobio agreement.

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Table of Contents

Governmental Regulation

Our operations are regulated by federal, state and foreign governmental authorities. Failure to comply with the applicable laws and regulations can subject us to repayment of amounts previously paid to us, significant civil and criminal penalties, loss of licensure, certification, or accreditation, or exclusion from state and federal health care programs. The significant areas of regulation are summarized below.

Clinical Laboratory Improvement Amendments of 1988 and State Regulation

Each of our clinical laboratories must hold certain federal, state and local licenses, certifications, and permits to conduct our business. Laboratories in the United States that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease are subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and