definiens: means all development activities for the Licensed Products that are directed to obtaining Regulatory Approval(s ) of the Licensed Pr oducts, including all non- clinical, preclinical, a nd clinical testing and studies of the Licensed Products ; toxic ology, pharmacokinetic, and pharmacological studies ; CMC activities ; statistical analyses ; assay development ; protocol design and development ; the preparation, filing, and prosecution of any MAA for the Licensed Products ; d evelopment activities directed to label expansion a nd / or obtaining Regulatory Approval for one or more addit ional indications following initial Regulatory Appr oval ; development activities conducted after the launch, excluding any post- approval clinical trials that a re not conducted for obtaining Regulatory Approval(s ) ( but, for 1.23 clarity, including any post - approval clinical trial s that must be conducted to maintain Regulatory App roval ) ; and all regulatory affairs related to any of the forego ing including negotiations with Regulatory Authorit y and the product labeling or label change . and have correlative meanings