Joint Global Study Management Plan Clause Samples

Joint Global Study Management Plan. The Project Team shall set up a mechanism for the Parties to be informed and updated on a timely periodic basis regarding Operational Matters, so that if either Party has any significant concerns or material disagreements regarding same, the matter can be escalated to the CC for review (the “Joint Management Plan”) and shall ensure adherence to such plan in its Sponsored Territory. In addition, the Parties will, by itself or through an approved vendor, review the monitoring reports generated in each Joint Global Study in all Sponsored Territories in a timely manner. All such monitoring reports shall be in English. Notwithstanding anything to the contrary in this Collaboration Agreement, in the event that the Sponsor Party receives communication from a Regulatory Authority requesting an immediate response or otherwise as stipulated by laws and regulations that the Sponsor Party reasonably determines must be immediately given to protect patient safety or to prevent undue and significant disruption in the conduct of a Joint Global Study, the Sponsor Party will be entitled to provide such response as it deems advisable (and that is otherwise consistent with the terms of this Agreement); provided, that it immediately notifies the Project Team of same.