definiens: or means all development activities for any Compound or Collaboration Product thatare directed to obtaining Marketing Approval(s ) of the Collaboration Products, including : all non - clinical, preclinical andclinical activities, testing and studies of such Compound or Collaboration Product ( including IND - Enabling Studies andtranslational research ) ; manufacturing development, process and formulation development ; toxicology, pharmacokinetic, pharmacodynamic, drug - drug interaction, safety, tolerability and pharmacological studies ; distribution of such Compound orCollaboration 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 thepreparation, filing and prosecution of any MAA for such Collaboration Product ; development activities directed to labelexpansion ( including prescribing information ) and/or obtaining Marketing Approval for one or more additional Indicationsor patient populations following initial Marketing Approval ; development activities conducted after receipt of MarketingApproval which were a condition for the receipt of such Marketing Approval ; and all regulatory activities related to any of theforegoing