Joint Exploratory Development Plan; Amendment Clause Samples

Joint Exploratory Development Plan; Amendment. The Parties have agreed on a joint exploratory development plan, attached to this Agreement as Schedule 4.3(a), that sets forth (i) the plans for characterization of Lead Compounds and Development Candidates existing as of the Effective Date; (ii) the Initial Indications in which the Parties intend to conduct Indication Survey Studies; (iii) the general parameters of such Indication Survey Studies, including number of participants and duration of treatment; (iv) the Related Indications for the Initial Indications as determined by the Parties as of the Effective Date; and (v) overall budget for such activities (such plan, the “Joint Exploratory Development Plan”, and such Development activities, the “Joint Exploratory Development”). From time to time, the Parties may amend the Joint Exploratory Development Plan to include other similar activities within the scope of Exploratory Development Activities that the Parties agree to jointly conduct and fund. To that end, either Party may propose any amendment to the Joint Exploratory Development Plan to the JRDI (including adding newly designated Lead Compounds for characterization in Non-Clinical Studies, adding newly designated Development Candidates for characterization in IND-enabling Non-Clinical Studies or adding or changing Indications for Indication Survey Studies), and any such amendment shall be effective upon the approval of the JRDI. If the JRDI cannot agree on any such proposed amendment 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: (A) [***]; and (B) [***].