New Development by Partner Clause Samples
New Development by Partner. Notwithstanding Partner’s final decision-making authority with respect to Development activities for the Licensed Product that are Territory-specific as set forth in Section 3.6.2(b) (Partner Final Decision-Making Authority), if Partner proposes to perform any Clinical Trials for or otherwise Develop (a) a new formulation of the Licensed Product, (b) any new combination regimen or fixed dose combination for the Licensed Product and another agent, or (c) the Licensed Product in a new Indication, in each case ((a), (b), and (c)) that is not already the subject of the Global Development Plan or Territory Development Plan (“New Development”) for the Territory, then Partner will present to the JSC to review, discuss, and determine whether to approve a proposal to add such Development activities for such New Development to the Territory Development Plan for the Licensed Product, including the countries or regions in the Territory in which such activities would be conducted (a “New Development Proposal”). Each New Development Proposal will describe in reasonable detail the applicable Clinical Trials that Partner desires to conduct with respect to such New Development, including a synopsis of the trial or activities, the proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering (the “New Development Activities”), as well as a proposed timeline and budget and an analysis of the business opportunity and revenue potential anticipated to result from such New Development Activities. The JSC will review, discuss, and determine whether to approve a New Development Proposal within [***] days after receipt thereof from Partner. Upon such an approval, (a) the New Development Activities set forth in such New Development Proposal will be “New Territory-Specific Development Activities” for purposes of this Agreement, and (b) the JDC will update the Territory Development Plan for the Licensed Product to include such New Territory-Specific Development Activities for those countries or regions in the Territory agreed by the JSC, including the proposed timelines, in each case, for such New Development Activities set forth in such New Development Proposal (as may be amended by the JSC upon such approval). Any New Territory-Specific Development Activities included in a Territory Development Plan pursuant to this 5.4 (New Development by Partner) will be Development activities for all purposes under thi...