Process for Changes to Plan Sample Clauses

Process for Changes to Plan. (1) Changes with respect to the Initial Indication. Either party may propose changes with respect to the Initial Indication to the Joint Development Plan (which may include changes to the Shared Cost Budget) from time to time, via the JDC. The JDC shall discuss such changes to the Joint Development Plan (which may include changes to the Shared Cost Budget requested by either party). The JDC shall also review the Joint Development Plan (including such budgets) annually. Any changes to the Joint Development Plan with respect to the clinical protocol or territorial distribution of subjects for any clinical trial for the Initial Indication shall be made only by the mutual written approval of the parties. Any changes to the to the Shared Cost Budget, which increase such budget by [***], individually or aggregated together with other Shared Cost Budget changes that were not made by consensus, shall be made only by the mutual written approval of the parties. Any such mutual written approval may be either in the form of a JDC action unanimously approved by the parties, or in the form of a written amendment signed by authorized officers of both parties. If one party wishes to make a change to any element of the Joint Development Plan with respect to the Initial Indication, that is described above to require consensus between the parties, then the change shall not be made and the matter shall not be referred to arbitration in accordance with Article 15 nor shall it be justiciable. If one party wishes to make a change to any element of the Joint Development Plan for the Initial Indication other than in a way that require consensus between the parties as described above in this Section, the matter shall be resolved in accordance with Section 3.1(f). Each Party hereby acknowledges that amendments to clinical protocols that require submission to a Regulatory Authority or material changes in the territorial distribution of patients, even when not having a budgetary impact, can have a material impact on the utility of the resulting data to each Party in its respective territory, and therefore such changes in clinical protocols and territorial distributions in trials for the Initial Indication shall be made only by consensus. *** Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (2) [***] .