Selection of Development Plan Sample Clauses

Selection of Development Plan. For each of Licensed ABI-H2158 Products and Licensed ABI-H3733 Products, promptly after the first end-of-phase 2 (EOP2) meeting between AssemblyBio and the applicable Regulatory Authority, the Parties shall discuss through the JDC the path forward for the joint Development of the Licensed ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable), and shall discuss (A) whether to conduct a ▇▇▇▇▇▇▇▇▇-▇▇▇▇ ▇▇▇▇▇ ▇ Clinical Trial for such Licensed Products, including the study design, protocol, the number of patients to be enrolled for such Phase 3 Clinical Trial, and the related budget for such Development activities; and (B) (x) whether the Territory will be part of the Joint Global Study, and (y) if the Territory will be part of the Joint Global Study, the study design and protocol for the Territory-portion of such Joint Global Study, the number of patients to be enrolled for such Joint Global Study in the Territory (pursuant to Section 5.2(b)), and the related budget for such Development activities. If the JDC decides to move forward with the ▇▇▇▇▇▇▇▇▇-▇▇▇▇ ▇▇▇▇▇ ▇ Clinical Trial for such Licensed Products, such Development activities will be governed by a Territory Development Plan pursuant to Section 5.3(a) and subject to the cost sharing arrangement under Section 5.4. If the JDC decides to move forward with a Joint Global Study, such Development activities will be governed by a Global Development Plan pursuant to Section 5.2(a) and the Territory-portion of such Joint Global Study shall be subject to the cost sharing arrangement under Section 5.4. If the JDC cannot reach an agreement regarding the path forward for the joint Development of the Licensed ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable) within [* * *] following the first EOP2 meeting between AssemblyBio and the applicable Regulatory Authority, such matter shall be referred to the Executive Officers of both Parties for resolution. All discussion between the Parties under this Section 5.2(d)(i) shall be conducted and all decisions related thereto shall be made in good faith. For clarity, AssemblyBio shall retain operational control and full discretion over any Development activities outside of the Territory (including any global study that does not include the Territory or any portion of a Joint Global Study that is outside of the Territory).