New Development Proposal Clause Samples

New Development Proposal. Either Party may propose with respect to the Licensed Products in the Territory new Development activities (including the Development of a Licensed Product for a new Indication or as part of a Combination Product, excluding the Development of Licensed Products before the Initiation of Phase 3 Clinical Trial thereof) not currently set forth in an existing Territory Development Plan with its study design, protocol, specific Development activities allocated to each Party, and the budget for such allocated activities (each proposal, a “New Development Proposal”). The JDC will review, discuss and determine whether to approve each New Development Proposal within [* * *] after the receipt thereof. If the JDC approves by consensus such New Development Proposal, (i) the Parties will, through the JDC, update the Territory Development Plan to include the Development activities proposed in the New Development Proposal, and (ii) the Development and Regulatory Costs incurred with respect to the Development activities proposed in the approved New Development Proposal will be subject to Section 5.4.