Component Plans Sample Clauses

Component Plans. The Construction Environmental Management Plan (CEMP) shall consist, when applicable, of the following major components to address the various phases of the work:
Component Plans. The JMC shall ensure that at least the following plans and budgets shall be prepared with respect to Products, and updated at least prior to each JMC meeting until the subject activities have been completed. (a) Pre-clinical R&D Plan and Budget. To facilitate the advancement of Products for the Initial Indications to IND filing, the JPT shall develop a Pre-clinical R&D Plan and Budget that will describe in detail the specific activities, timelines and budgets for advancement of Products for each of the Initial Indications until IND filing, which shall include activities to assess efficacy and safety and validate Licensed Compound selection. (b) CMC Plan and Budget. To facilitate the manufacture of Products, the JPT shall develop a CMC Plan and Budget for the applicable Product describing in detail the specific activities, timelines, and budgets for (i) selection of the manufacturing process; and (ii) manufacture of pre-clinical R&D materials, clinical trial and commercial supplies of such Product.