definiens: means any multi - national, national, federal, stat e, local, provincial, municipal, or other governmental authority of any nature ( includi ng any governmental division, subdivision, departme nt, agency, bureau, branch, office, commission, council, court, or other tribunal ) . [ See License Agreement Section 1.54 ] means International Conference on Harmonization . [ See License Agreement Section 1.56 ] means an Investigational New Drug application as defined in the FFDCA, or a clinical trial authoriza tion application for a pharmaceutical product filed with a Regulatory Authority in any other regulatory jur isdiction outside the U.S., the filing of which is necessary to commence or conduct clinical testing of such pha rmaceutical product in humans in such jurisdiction . [ See License Agreement Section 1.58 ] means information, discoveries, compounds, compos itions, formulations, formulas, practices, procedures, processes, methods, knowledge, know - how, trade secrets, techniques, designs, drawings, correspondence, computer programs, documents, appar atus, results, strategies, regulatory documentation, information and submissions pertaining to, or made in association with, filings with any Governmental Authority or Patent Office, data, including pharmacological, toxicological, non - clinical and clinical data, raw data, analytical and quality control data, manufacturing data and de scriptions, market data, financial data or descript ions, devices, assays, chemical formulations, specifications, mate rial, product samples and other samples, physical, chemical and biological materials and compounds, and the like, i n written, electronic, oral or other tangible or in tangible form, now known or hereafter developed, whether or not pa tentable, and any copyrights therein . [ See License Agreement Section 1.63 ] means all rights in Patent Rights, Trademarks, co pyrights, design rights, database rights, moral rights, Information, Inventions, and any and all other intellectual property or propriet ary rights ( whether registered or unregistered ) now known or h ereafter recognized in any jurisdiction, and all ap plications and rights to apply for any of them, anywhere in th e world . [ See License Agreement Section 1.66 ] means any and all inventions, improvements, disco veries, and developments, whether or not patentable, made, conceived, or reduced to practice in the course of performance of this Agreement whe ther made, conceived, or reduced to practice solely by, or on behalf of, [COMPANY], Licensee, the Parties jointly, o r any Affiliate of either Party . [ See License Agreement Section 1.67 ] means a Japanese new drug application and any oth er applicable submission to the PMDA for pharmaceutical, biologic, or device approval . [ See License Agreement Section 1.68 ] means any Inventions that are made jointly by emp loyees, agents, or independent contractors of each Party in the course of performing activitie s under this Agreement, together with all Intellect ual Property Rights therein . [ See License Agreement Sections 1.61, 10.1 ] means all Information and Inventions jointly gene rated by Licensee and [COMPANY] during the Term that pertain to the Exploitation of the Licens ed Compounds or Licensed Products in the Field in t he Territory