Sample Profiling and Reserved Capacity Clause Samples

Sample Profiling and Reserved Capacity. FMI shall provide, and shall reserve capacity to provide, Roche with comprehensive profiling, analysis and reporting (“Sample Profiling”) of at least […***…] during the first […***…] immediately following the Effective date, and at least […***…] samples during the next […***…] (“Reserved Capacity”) using FMI’s platform for molecular genomic profiling of cancer samples (the “Genomic Analysis Platform”). The initial laboratory and computational biology activities performed on the Samples as part of Sample Profiling are “Genomic Analyses”. FMI will provide Sample Profiling in accordance with the Reserved Capacity during the Profiling Term and Profiling Renewal Term, using the then-current versions of the tests included in its Genomic Analysis Platform. The Sampling Profiles shall be provided in a specified format to be mutually agreed by the Parties. The JMC will discuss and decide upon the Reserved Capacity commitment for Profiling Renewal Terms, provided that any Reserved Capacity amount in excess of […***…] that would require FMI to increase its existing capacity will require FMI approval. Sample Profiling will include advanced genomic analyses, i.e. advanced laboratory and computational biology activities in the field of cancer genomic sequencing and analysis performed on Samples, including […***…] (collectively, “Advanced Genomic Analyses”). Sample Profiling includes Genomic Analyses and Advanced Genomic Analyses. FMI may adopt modifications to the Performance Specifications without Roche’s consent, so long as such modifications do not result in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57 (which such material diminution would require the prior written consent of Roche). In the event […***…], and such change results in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57, Roche may, at its election, and upon written notice to FMI, terminate each Party’s obligations under Reserved Capacity, including Roche’s obligations under Section 8.2.1.1 to pay Reserved Capacity Fees and opt out of the price per Sample fees for Sample Profiling otherwise specified in Section 8.2.1.2, in each case, from the effect of such sequencing platform change. If Roche elects to terminate the Parties’ obligations under Reserved Capacity and opts out of the per Sample pricing for Sample Profiling specifi...