SOPs. Subject to the terms hereof, for future Trials, OPKO will conduct, or ensure that each Approved CRO conducts, all Trials in accordance with standard operating procedures (the “SOPs”), access to electronic copies of which will be provided by OPKO to the JDC for review prior to the initiation of each Trial at a time to be determined by the JDC. For existing Trials OPKO will provide access to electronic copies of all current SOPs within ninety (90) days following the Effective Date. Pfizer, from time to time, may request OPKO to make amendments to current SOPs if, in Pfizer’s opinion, these changes are required to meet regulatory requirements or will have a material impact on the success of any BLA submission by Pfizer. In the event of any updates to existing SOPs, or in the event that any Trial is not being conducted in compliance with the SOPs (as updated from time to time), OPKO shall take all such actions as may be necessary to bring such Trial into compliance with the then-current SOPs as promptly as is practicable.
Appears in 2 contracts
Sources: Development and Commercialization License Agreement, Development and Commercialization License Agreement (Opko Health, Inc.)