Common use of Clinical Development Plan Clause in Contracts

Clinical Development Plan. The Parties shall ensure at all times that the Clinical Development Plan (a) is consistent with the terms and conditions of this Agreement, (b) is focused on efficiently obtaining Regulatory Approval for Licensed Products (whether as a monotherapy or as part of a Combination Therapy) in each Initial Indication and Additional Indication (other than a Rejected Additional Indication) in the Territory, (c) does not include activities that could reasonably be expected to have a material adverse effect on the Development, Manufacture or Commercialization of Licensed Compound or Licensed Products outside of the Territory; and (d) does not include activities that constitute or potentially constitute a violation of the requirements set out in Applicable Law in the Territory. The Clinical Development Plan shall provide a summary of each bridging study, Local Trial, Joint Global Trial, investigator sponsored trial and registry study to be conducted any Hutchmed Entity in the Territory, including in reasonable detail (i) all material Development activities reasonably anticipated to be undertaken by the Hutchmed Entities or Hutchmed Entities and Epizyme Entities, (ii) the endpoints for all clinical trials contemplated by such plan, (iii) identification of the clinical trials that are intended to be a Pivotal Trials, (iv) all material regulatory activities and Regulatory Authority interactions anticipated to be conducted by the Hutchmed Entities in support of Regulatory Approval of the Licensed Products in the Field in the Territory, including all planned material Regulatory Filings to be submitted in connection with such approvals, and (v) the budget for Hutchmed’s share of costs associated with participation in Joint Global Trials in accordance with Section 9.3(c)(iii). Each Party shall be responsible for determining the budget for its activities in its respective territory for Joint Global Trials.