definiens: shall mean know - how, trade secrets, procedures, i nformation, technology, experimental data, pre - clinical, non - cl inical and clinical data, clinical safety, post - mar ket safety, efficacy or comparative data, including without lim itation raw or patient data, and any and all materi al information or reports relating to the development, registratio n, manufacture and commercialization of a Product t hat is reasonably necessary or required for Regulatory App roval of a Product . For illustration, Regulatory In formation includes, but is not limited to draft and final cop ies of all NDAs and INDs that are to be submitted o r have been submitted by JT and [COMPANY] or their respective Affi liates to the regulatory authorities, including, wi thout limitation, the FDA or EMA, and that are included in other NDAs and INDs for a Product filed by either Party or it s Affiliates, together with all material subsequent correspondenc e and data submissions relating to the foregoing, a nd all improvements or inventions made or obtained by eith er Party or its Affiliates, which are reasonably ne cessary or required to the formulation of a Product or the man ufacture, development and registration of a Product