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Test Terms

Oncology contract terms

On March 30, 2021, Illumina made available a standard contract to any U.S. oncology customer.

At a high level, the terms of the standard contract include the following:

  • A 12-year supply contract for Illumina’s sequencing products sold in the United States, specifically, Illumina’s NextSeq and NovaSeq instruments and sequencing consumables.
  • Guaranteed access to the latest sequencing products, and related product and support services.
  • No price increases for the sequencing products covered by the agreement.
  • Guaranteed lower pricing for the sequencing products by 2025: the cost per gigabase of sequencing on Illumina’s highest throughput instrument, using the highest throughput flow cell, will be at least 43% lower than the comparable cost per gigabase today, under Illumina’s standard terms.
  • Illumina will not discontinue any of the sequencing products supplied under the agreement as long as an oncology customer continues to purchase that product.
  • Provision of any documentation or information reasonably required to seek FDA approval or FDA marketing authorization to sell a clinical test using the sequencing products supplied under the agreement.
  • Any oncology customer can also enter into a separate agreement to develop a distributable in vitro diagnostic kitted test using Illumina’s FDA-approved instruments.

Additional terms and conditions apply. The standard supply contract (and standard IVD agreement terms) may be viewed here. On September 8, 2021, Illumina made available an addendum to the supply contract which may be viewed here.

U.S. oncology customers can enter into any of the following contracts to develop distributable in vitro diagnostic kitted tests on an Illumina platform, which contracts apply the same terms as in the IVD term sheet:

  • An agreement to develop and commercialize an unlimited number of in vitro diagnostic test kits for use on Illumina’s NextSeq 550Dx and future Illumina regulatory-approved Dx sequencing platforms, for a term of 15 years. View contract here.
  • An agreement to develop and commercialize up to three in vitro diagnostic test kits for use on Illumina’s NextSeq 550Dx, for a term of 10 years. View contract here.
  • An agreement to develop and commercialize up to three in vitro diagnostic test kits for use on the expected Illumina NovaSeq-based regulatory-approved Dx sequencing platform, for a term of 10 years. Illumina does not guarantee that such a platform will receive regulatory approval in any jurisdiction. View contract here.

GRAIL’s Product and Service Purchasing may be viewed here.