definiens: means fully - burdened costs and expenses incurred b y or on account of Licensee and its Affiliates in conductin g development activities that are directed to or useful for obtaining or maintaining marketing appro val(s ) of a Licensed Product, including : all non - clinical, preclinical and clinical activities, testing and studies of such Licensed Product ( including IND - enabling Studies and translational r esearch ) ; manufacturing development, process and formulation development ; toxicology, pharmacoki netic, pharmacodynamic, drug - drug interaction, safety, tolerability and pharmacologic al studies ; distribution of such Licensed Product for use in clinical trials ( including placebos and comparators ) ; data and statistical analyses ; assay development ; instrument design and development ; pro tocol design and development ; quality assurance and control ; report writing ; and the prep aration, filing and prosecution of any regulatory filings and applications for marketing approval for Licensed Product ; development activities directed to label expansion ( including prescribing information ) and/or obtaining marketing approval for one or more additional indications or patient populations following initial marketing approval ; development activities conducted after re ceipt of marketing approval which were a condition for the receipt of such marketing approva l ( including Phase IV studies ) ; and all regulatory activities related to any of the foregoi ng