Phase IIb Plan Clause Samples

Phase IIb Plan. (1) For any Product Candidate that is being jointly Developed and that has been determined by the applicable JDC to be ready for Development in Phase IIb Clinical Studies pursuant to Section 5.5(a)(i) or Section 5.5(a)(vi), the JDC shall prepare a written plan setting forth: (A) the Development activities (including the Phase IIb Clinical Study, any Non-Clinical Studies and potentially other Clinical Study(ies)) to be conducted by the Parties for such Product Candidate with the goal of determining whether such Product Candidate should be further Developed in Phase III Clinical Studies, and if so, obtaining the Clinical Data and other results necessary to meet the requirements of the Regulatory Authorities in order to commence Phase III Clinical Studies for such Product Candidate and related Manufacture and supply matters (such activities collectively, the “Phase IIb Development”), including the protocol for the proposed Phase IIb Clinical Study or other related such studies; (B) the allocation of the conduct of the activities under such Phase IIb Development between the Parties; (C) the timeline associated with such Phase IIb Development; and (D) the budget for such Phase IIb Development (the “Phase IIb Plan”). Any such Phase IIb Plan shall be effective upon approval of the JDC, either by the agreement of the JDC or, in the case of disagreement, as set forth in Section 5.5(b)(i)(2) below. (2) If the JDC cannot agree on the Phase IIb Plan within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then the Phase IIb Clinical Study for such Product Candidate [***].