definiens: means any and all results of research, preclinica l studies, including in vitro and in vivo studies, clinical trials and other testing of Lice nsed API or Licensed Product conducted by or on behalf of a Party or any of its Affiliates ( or in the case of [COMPANY], its Third Party Partners ) to the extent Controlled by such Party ei ther before or during the Term, and any and all oth er data generated by or on behalf of a Party related to the development, manufacture or commercialization of L icensed API or Licensed Product, including safety data, bio logical, chemical, pharmacological, toxicological, pharmacokinetic, clinical, CMC, analytical, quality control, and other data, results and descriptions and, if requested, raw data associated with the conduct of any Clinical Trial for the Licensed API or Licensed Product ( including the SCLC Post - Approval Commitment Studie s ) ; provided however that, except for that data tha t is necessary for Jazz to carry out its regulatory and quality obligations as the holder of the NDA for th e Licensed Product, Licensed Product Data shall not include an y data or Information which is included in any sect ion of the DMF other than Section S of Module 3 of the NDA and is not otherwise publicly available