definiens: or means all development activities for Tirasemtiv orProduct that are directed to obtaining or maintaining Marketing Approval(s ) of the Product, including : all non - clinical, preclinical and clinical activities, testing and studies of Tirasemtiv orProduct ( including IND - Enabling Studies and translational research ) ; manufacturingdevelopment, process and formulation development ; toxicology, pharmacokinetic, pharmacodynamic, drug - drug interaction, safety, tolerability and pharmacological studies;distribution of Tirasemtiv or Product for use in clinical trials ( including placebos andcomparators ) ; statistical analyses ; assay development ; instrument design and development;protocol design and development ; quality assurance and control ; report writing ; and thepreparation, filing and prosecution of any MAA for the Product ; development activities directed tolabel expansion ( including prescribing information ) and/or obtaining Marketing Approval for oneor more additional Indications or patient populations following initial Marketing Approval;development activities conducted after receipt of Marketing Approval which were a condition forthe receipt of such Marketing Approval ; and all regulatory activities related to any of theforegoing