FDA Cases. Within fifteen (15) days of --------- receipt by GEMS of written approval from the IRB, GEMS shall deliver to R2 the PMA data set, consisting generally of 44 "cancer cases" and 100 "benign cases." If the FDA requires more than the number of cases referred to above in order to approve the R2 Product, then GEMS and R2 shall negotiate in good faith to determine how many more cases need to be accrued, how to obtain them and how to share the costs thereof.
Appears in 2 contracts
Sources: Distributor Agreement (R2 Technology Inc), Distributor Agreement (R2 Technology Inc)