During the Late Clinical Development Term, each Party will keep the JDC fully informed regarding the progress and results of Development activities for Development Candidates and associated Products in the Territory (including any Supplemental Trials), including an annual review of results versus goals (as such goals are set forth in the Late Clinical Development Plan(s)).

During the Late Clinical Development Term for a Development Candidate, all Development of such Development Candidate and associated Product pursuant to this Agreement and activities to support and obtain Regulatory Approvals for such Development Candidate and associated Product in the Territory will be conducted pursuant to a development plan and budget (such plan, a “Late Clinical Development Plan” with respect to each Development Candidate) that describes # the proposed overall program of Development for the applicable Development Candidate, including all Clinical Trials, in the Territory, # the anticipated start dates and data availability dates of such Clinical Trials, # the proposed activities to support and obtain Regulatory Approvals for such Development Candidate and associated Product in the Territory, # the respective roles and responsibilities of each Party in connection with such activities, and # a detailed budget for all such activities in the Territory. In the event of any inconsistency between a Late Clinical Development Plan and this Agreement, the terms of this Agreement will prevail.