Plan Amendments Unilateral Development Sample Clauses

Plan Amendments Unilateral Development. 2.5.1 Criteria for Amendments to the Development Plan. Either Party, through its representatives on the JDC, may propose amendments to the Development Plan, including modifications to a Clinical Study or Post Approval Study already initiated and ongoing under the Development Plan or the addition of new Clinical Studies for Additional Indications for the Licensed Product (including for a higher line of therapy for an indication that is already under Development) and Post Approval Studies for the Licensed Product. Any material amendment proposed by a Party to the Development Plan with respect to a Clinical Study or Post Approval Study must meet the following criteria, as applicable: (a) Any proposed Exploratory Study, or any material amendment thereto, whether or not contemplated in the Development Plan as of the Effective Date, shall be designed to comply with all applicable regulatory guidelines of both the FDA and the EMEA; (b) Any proposed Post Approval Study, or any material amendment thereto, whether or not contemplated in the Development Plan as of the Effective Date, shall be designed to satisfy all applicable regulatory requirements of both the FDA and the EMEA; (c) Any proposed Registrational Study, whether or not contemplated in the Development Plan as of the Effective Date, shall be: (i) based on a scientific rationale supported by the results of an Exploratory Study; and (ii) designed to satisfy regulatory requirements of both the FDA and the EMEA, including, where applicable, conforming to any scientific advice obtained by a Party from Regulatory Authorities in its portion of the Territory. Any proposed Registrational Study that is not contemplated in the Development Plan as of the Effective Date must, in addition to the criteria in clause (i) and (ii) above, be for an indication having sufficient commercial potential in both the United States and Europe to justify conduct of the study taking into consideration the risks of adverse results. (d) Any material amendment proposed by a Party with respect to a Registrational Study already initiated and ongoing under the Development Plan must be either suggested by Regulatory Authorities or otherwise required or reasonably necessary to obtain Regulatory Approval in the proposing Party’s portion of the Territory. Notwithstanding the foregoing, either Party may propose a material amendment that does not meet the foregoing criteria if both Parties agree to the proposal. The Party that is proposing any am...