Clinical Development Plan. Within [***], the JSC will propose and agree on a high-level clinical development plan and regulatory strategy for any potential Development Candidate through completion of the first Pivotal Study, which plan may include activities related to the identification of biomarkers, natural history studies and endpoint development, if determined by the JSC (such plan the “Clinical Development Plan”). Praxis will propose the initial draft of such Clinical Development Plan to the JSC for review, comment and approval. Any such initial draft of the Clinical Development Plan will include the information set forth on SCHEDULE 3.7. If the JSC cannot agree upon the Clinical Development Plan, the matter will be referred to the Senior Representatives for resolution. Subject to Section 4.1.4(b) (but only with respect to [***]), if the Senior Representatives cannot agree on the Clinical Development Plan within [***] after the matter is so referred, Praxis will have final decision-making authority with respect to the [***].
Appears in 3 contracts
Sources: Research Collaboration, Option and License Agreement (Praxis Precision Medicines, Inc.), Research Collaboration, Option and License Agreement (Praxis Precision Medicines, Inc.), Research Collaboration, Option and License Agreement (Praxis Precision Medicines, Inc.)