definiens: shall mean all non - clinical activities and clinic al activities designed to obtain any Marketing Authorization of a Collaboration Compound, Product, Small Molecule Collaboration Compound or Small Molecule Product, as applicable, in accordanc e with this Agreement or to be used in the Commercialization of the Product or Small Molecule Product ( except for Phase 4 Clinical Trials ), including the toxicology studies, pharmacokinetic, pharmacodynamic and other non - clinical studies, statistical analysis and report writing, Clinical S tudy design, pre - Marketing Authorization medical affairs activities and operations, preparing and fi ling regulatory filings and all regulatory affairs related to the foregoing, as well as any and all activities pertaining to manufacturing and formulation development and lifecycle management, including new indications, new formulations and all other activities related to securing Marketing Authorizat ion for such Collaboration Compound, Product, Small Molecule Collaboration Compound and/or Small Molecule Product . and shall have correlative meanings