Co-Development Plan means, with respect to each Co-Developed Product, the written plan describing the joint Development activities to be carried out by both Parties over each Contract Year commencing with the date of exercise of the Co-Development Option in accordance with Section 5.1.1 for each Co-Developed Product, broken down by Calendar Quarters, and which
Unless otherwise specified in a Co-Development Plan and Budget amounts reflected for a full year shall be deemed budgeted in equal amounts for each calendar quarter of such year.
Upon Sunesis exercise of the Co-Funding Option, the Parties shall form a product team with respect to each Co-Funded Product that shall report to the JDC, comprised of Biogen Idec and Sunesis personnel that will implement the further development and regulatory affairs with respect to that Co-Funded Product (each a Product Team) in accordance with the Co-Development Plan and Budget.
For each Co-Funded Product, the Parties shall establish and maintain a JDC in accordance with Section 5.4 below, which shall be responsible for establishing the plan and budget for the development of each Development Candidate (each, a Co-Development Plan and Budget) and overseeing the implementation of such plan.
Such Co-Development Plan and Budget shall be comprehensive and shall fully describe at least the proposed activities related to ongoing preclinical studies, formulation, process development, clinical studies and regulatory plans, and other activities and timelines directed to obtaining the initial and subsequent Regulatory Approvals in each applicable country.
Except as otherwise provided in this Agreement, and subject to Section 5.5, all decisions with respect to the creation, modification and implementation of the Additional Co-Development Plan and all Development activities for the Additional Co-Development Product shall be made by Incyte in its sole discretion.