Training Cases. GEMS and R2 acknowledge -------------- that GEMS has provided to R2 data from one hundred (100) "normal cases" (cases containing no indication of cancer). In order to assist R2 in developing a prototype phase of the R2 Product as set forth in Section 2.4.1 and to obtain regulatory approvals from the FDA and all other governmental and regulatory approvals in the Territory, GEMS shall provide data no later than September 30, 2000 from a total of 200 "cancer cases" comprised of 100 cases containing an indication of microcalcification and 100 masses, that will constitute a database with a repartition in the pathology size corresponding to a screening population (the "Cancer Cases"). Such screening population shall consist of the following distribution guidelines: (a) lesions less than 2 cm.--at least 75% of the cases; (b) lesions between 2 cm. and 3 cm.--no more than 20% of the cases; and (c) lesions greater than 3 cm.--no more than 5% of the cases. Notwithstanding the foregoing, GEMS and R2 acknowledge and agree that such distribution percentages are to be used as guidelines for data collection and that R2 shall have no remedy against GEMS if such distribution percentages are not met. Such case data shall be provided by GEMS to R2 as soon as reasonably practicable after it is available to or captured by GEMS and after appropriate informed consent has been obtained from all affected subjects. GEMS shall proceed diligently to obtain such appropriate informed consent.
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Sources: Distributor Agreement (R2 Technology Inc), Distributor Agreement (R2 Technology Inc)