importation of such product, process or machine would infringe or misappropriate such Intellectual Property or, as to a pending claim in a patent application included in such Intellectual Property, the making, using, selling, offering for sale or importation of such product, process or machine would infringe such Intellectual Property if such pending claim were to issue in an issued patent without modification. The determination of whether a compound, formulation, process, product, machine or other Intellectual Property is Covered by a particular claim shall be made on a [***] basis.
1.13 Dollars or $ means the legal tender of the U.S.
1.14 Exploit and Exploitation mean to make, have made, import, use, have used, sell, offer for sale, have sold, reproduce, modify, publish, distribute, research, develop, commercialize, register, hold, keep (whether for disposal or otherwise), Manufacture, transport, distribute, promote, market, or otherwise dispose of.
1.15 FDA means the U.S. Food and Drug Administration or any successor entity.
1.16 Field means all prophylactic, palliative, therapeutic and/or diagnostic uses in connection with all human diseases and disorders (including development and research activities on animal models thereof) in the field of oncology, including all types of cancer.
1.17 First Commercial Sale means on a [***] basis, the first sale of a Licensed Product by a Selling Party following the receipt of all Regulatory Approval required for the commercial sale of such Licensed Product in such [***].
1.18 Generic Product means a product (a) whose active pharmaceutical ingredient is rated as equivalent to the Licensed Product being sold in a [***], (b) that obtained Regulatory Approval solely by means of establishing such equivalence to such Licensed Product, and (c) that is legally marketed in such [***] by an entity other than a Selling Party hereunder.
1.19 Governmental Authority means any transnational, or domestic or foreign federal, state or local, governmental authority, department, court, agency or official, including any political subdivision thereof.
1.20 IND means an Investigational New Drug application, or similar application to commence human clinical testing of a Licensed Product for use in the Field submitted to the FDA, or its foreign equivalent.
1.21 Intellectual Property (IP) means all rights in Patent Rights, Inventions, priority rights, copyrights, design rights, trade names, trademarks, service marks, trade secrets, Know-How, database rights, domain names and any and all other intellectual property rights (whether registered or unregistered) and all applications and rights to apply for any of them, anywhere in the world.
1.22 Invention means any new process, method, composition of matter, invention, discovery, development, article of manufacture, result, data, know-how, software, works of authorship, material, or information, whether or not patentable or copyrightable.
[***] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED]