Algorithm. Prior to GEMS commencing --------- discussions with the Institutional Review Board ("IRB"), R2 shall confirm in writing to GEMS that the R2 Product algorithm can process the PMA (pre-market approval) cases which are done in feasibility format and that R2 can use them for the PMA submission. In the event that the FDA does not accept these cases for R2's FDA submission, then GEMS and R2 shall negotiate in good faith to determine how to acquire additional cases as outlined in Section 2.8.3.
Appears in 2 contracts
Sources: Distributor Agreement (R2 Technology Inc), Distributor Agreement (R2 Technology Inc)