Clinical Development Plan. (a) Initial Clinical Development Plan. Within ninety (90) days of the Effective Date, OV shall develop and document an initial comprehensive plan for a clinical development Program for conducting the Phase 2 Clinical Trial for the Primary Indication in accordance with the terms of this Agreement, with the long term goal of obtaining Regulatory Approval for the Product in the relevant jurisdictions of the Territory as decided by the JDC (the “Initial Clinical Development Plan”). The Initial Clinical Development Plan, which shall include a budget and timeline for activities, shall be attached hereto as Exhibit A and is incorporated herein and made a part hereof by reference. OV shall introduce the Initial Clinical Development Plan at the first meeting of the JDC following the above ninety (90) day period. Any existing or future studies conducted with the National Cancer Institute (“NCI”) or any investigator-sponsored trials (“ISTs”) shall be part of the Clinical Development Plan.
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Sources: Drug License and Development Agreement (Lantern Pharma Inc.), Drug License and Development Agreement (Lantern Pharma Inc.)