definiens: or means all research and development activities for any FSRA or FSRA Product thatare directed to, or useful for, obtaining Marketing Approval(s ) of any FSRA Product, including : all non - clinical, preclinical and clinical activities, 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 andpharmacological studies ; distribution of any such FSRA or FSRA Product for use in clinical trials ( including placebos and comparators ) ; statisticalanalyses ; assay development ; instrument design and development ; protocol design and development ; quality assurance and control ; reportwriting ; 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 Marketing Approval for one or more additional Indications or patient populations followinginitial Marketing Approval ; development activities conducted after receipt of Marketing Approval which were a condition for the receipt of suchMarketing Approval ; and all regulatory activities related to any of the foregoing