definiens: or means all research and development activities for any FSRA or FSRA Product that are directed to, or useful for, obtaining Marketing Approval(s ) of any FSRA Product, including : all non -clinical, preclinical and clinical act ivities, testing and studies of any such FSRA or FSRA Product ( including IND -enabling studies and translational research ) ; manufacturing development, process and formulation development ; toxicology, pharmacokinetic, pharmacodynamic, drug -drug interaction, safety, tolerability and pharmacological studies ; distribution of any such FSRA or FSRA Product for use in clinical trials ( including placebos and comparators ) ; statistical analyses ; assay development ; instrument design and development ; protocol design and development ; quality assurance and control ; report writing ; and the preparation, filing and prosecution of any MAA for all such FSRA Products ; development activities directed to label expansion ( including prescribing information ) and/or obtaining Marketin g Approval for one or more additional Indications or patient populations following initial Marketing Approval ; development activities conducted after receipt of Marketing Approval which were a condition for the receipt of such Marketing Approval ; and all r egulatory activities related to any of the foregoing