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.

All Development of any given Development Candidate during the Early Clinical Development Term will be conducted pursuant to a development plan and budget (such plan, an “Early Clinical Development Plan” with respect to each Development Candidate) that describes # the proposed overall program of Development for the applicable Development Candidate, including Phase 1 Clinical Trials in particular, at least one (1) Qualifying Phase 1 Clinical Trial, # the anticipated start dates and data availability dates of Phase 1 Clinical Trials, # 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 an initial Early Clinical Development Plan and this Agreement, the terms of this Agreement will prevail.

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)).

In General. The Parties intend that each Early Clinical Development Plan and Late Clinical Development Plan will set forth the regulatory strategy for seeking Regulatory Approvals (including any pricing and reimbursement approvals) in the Territory for all Development Candidates and Products. All decisions regarding regulatory issues will be made in accordance with the decision-making rules set forth in Article 2.