any other regulatory jurisdiction outside the U.S., the filing of which (in the case of (a) or (b)) is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction, or (c) documentation issued by a Regulatory Authority that permits the conduct of clinical testing of a product in humans in such jurisdiction.
1.40“Information” means information, ideas, inventions, discoveries, compounds, compositions, formulations, formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, technology, techniques, designs, drawings, correspondence, computer programs, documents, apparatus, results, strategies; Regulatory Documentation 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, analytical and quality control data, manufacturing data and descriptions, market data, financial data or descriptions; devices, assays, chemical formulations, specifications, material, product samples and other samples, physical, chemical and biological materials and compounds, and the like; whether in written, electronic, oral or other tangible or intangible form, now known or hereafter developed, whether or not patentable.
1.41“Inventions” means any and all inventions, discoveries and developments, whether or not patentable, made, conceived or reduced to practice in the course of performance of this Agreement, whether made, conceived or reduced to practice solely by, or on behalf of, Olema, Aurigene, the Parties jointly, or any Affiliate(s) of the same.
1.42“Know-How” means all Information and Inventions of each Party that are necessary or useful to Exploit Products in the Field in the Territory. [ * ].
1.43“Liability”, “Liabilities” means losses, damages, fees, costs and other liabilities incurred by a Party related to such Party’s performance or conduct, or by virtue of being a “Party”, under this Agreement.
1.44“Licensed Product” means any Product that contains an Aurigene Compound or Collaboration Compound as an active ingredient (alone or in combination with another active ingredient).
1.45“MAA” or “Marketing Authorization Application” means an application for Regulatory Approval (but, for clarity, excluding a Pricing Approval) in any particular jurisdiction other than the U.S.
1.46“Major European Country” means [ * ].
1.47“Major Market Country” means the [ * ].
1.48“Manufacture”, “Manufacturing” means all activities related to making, having made, producing, manufacturing, modifying, reproducing, validating, scaling up, processing, filling, finishing, assembling, packaging, labeling, quality control, quality assurance, testing and release, shipping and storing of a Product, or any ingredient thereof, placebo or comparator agent, as the case may be, including manufacturing of finished