definiens: or means under this Agreement, with respect to Licensed Products, the development activities conducte d before or after obtaining Regulatory Approval that are reasonably related to or leading to the development, preparation and submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting or expanding a Regulatory Approval, including but not limited to all activities related to pharmacokinetic profiling, design and conduct of pre - clinical development, non -clinical development, pre -clinical studies, in vitro studies, Clinical Studies, other studies and scientific activ ities ordinarily conducted in the pharmaceutical industry in the EMA territory and other countries of the DSE Territory as a prerequisite to or in connection with a Clinical Study, regulatory affairs, statistical analysis, report writing and regulatory fil ing creation and submission, including ( i ) Post - Approval Studies and ( ii ) studies that will result in an amendment to the indication included in the product labelling for the Licensed Product, but excluding for the avoidance of doubt, Research and Manufact uring and the conduct of Selected Clinical Activities