Protocol Amendments and Study Termination. If Opthea amends the protocol, agreement from the investigator must be obtained. The IRB / IEC must be informed of all amendments and give approval. Opthea reserves the right to terminate the study at any time either at a particular site or at all sites at any time and for any reason. Both Opthea and the investigator reserve the right to terminate the investigator’s participation in the study according to the study contract. If such action is taken, Opthea will discuss this with the investigator(s) at that time and notify the investigator(s) in writing. If the study is suspended or terminated for safety reasons all investigators conducting the study will be immediately notified of the action as well as the reason for it, as will the relevant regulatory agencies. The Investigator will advise the IRB / IEC overseeing the study at their site. Upon closure of the study (whether at the expected conclusion or prematurely), the following activities will be performed by the Sponsor in conjunction with the Investigator: • Return of all study data • Data clarification and resolution of queries • Study drug accountability, reconciliation and final disposition • Review of site study records for completeness • Shipment of all relevant samples to the central laboratory The investigator should notify the IRB / IEC in writing of the study’s completion or early termination and send a copy of the notification to Opthea.
