definiens: means all development activities for the Compound andProduct ( whether alone or for use together, or in combination, with another active agent orpharmaceutical product as a combination product or combination therapy ) that aredirected to obtaining Regulatory Approval(s ) of the Product and/or lifecycle managementof the Product in any country in the world, including all non - clinical, preclinical, andclinical testing and studies of the Product ; toxicology, pharmacokinetic, andpharmacological studies ; statistical analyses ; assay development ; protocol design anddevelopment ; the preparation, filing, and prosecution of any MAA for the Product;development activities directed to label expansion and/or obtaining Regulatory Approvalfor one or more additional indications following initial Regulatory Approval ; developmentactivities conducted after receipt of Regulatory Approval, including Phase 4 Clinical Trialsand Expanded Access Program ; and all regulatory affairs related to any of the foregoing