Common use of Global Trials Clause in Contracts

Global Trials. In the event the Parties mutually agree, through the JDC to jointly conduct or fund a Global Study, the JDC shall review and approve a Global Study plan (a “Global Study Plan”) setting forth the major steps, estimated timeline, protocol, estimated budget and other relevant details for such Global Study. For clarity, either Party may propose for the JDC’s review and approval of additional Indications to be part of a Global Study Plan. [***]. In the event the Parties intend to carry out any Global Study under a Global Study Plan, the Parties shall negotiate in good faith under the direction of the JDC regarding the details of the [***] arrangement for such Global Study. The Parties shall further negotiate in good faith an appropriate amount of compensation to be paid by ASCENTAGE to INNO for INNO’s contributions made for such Global Study. For any Global Study that INNO participates in the Territory, the relevant Global Study Plan shall also set forth the respective responsibilities of and activities to be carried out by each Party in the Territory for such Global Study, and the Parties shall use Commercially Reasonable Efforts to collaborate with each other to ensure that the trial participants from the Territory represent at least [***] of the total patients for such Global Study. For the purpose of this Agreement, “Global Study” means a multi-regional Study that is designed to obtain Regulatory Approvals for the Licensed Products in the Territory and outside the Territory; “Study” means the preclinical trials and Clinical Trials, toxicology testing, statistical analysis, publication and presentation of study results of a product.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Ascentage Pharma Group International), Collaboration and License Agreement (Ascentage Pharma Group International)