Clinical Development and Process Development Sample Clauses

Clinical Development and Process Development. Roivant is responsible for all manufacturing costs relating to clinical trials and development of the commercial manufacturing process. Such work includes, without limitation, active pharmaceutical ingredient development and acquisition, technical transfer costs, drug product formulation and development, stability testing, related analytical work, quality assurance review and batch release. Some (if not all) of these activities may be performed or overseen by Arena, at Roivant’s request and Roivant agrees that it will pay Arena for such requested activities an amount equal to Arena’s FTE Costs plus 37%, plus Arena’s out-of-pocket costs, without markup, or such other amount as the Parties agree, which payment shall be invoiced and paid in accordance with Section 3.11.