1.22 Non-Royalty Income means consideration in any form received by Company and/or Companys Affiliate(s) attributable to a grant of a sublicense or any other right, license, privilege or immunity to make, have made, use, have used, Sell or have Sold Licensed Products, but excluding consideration included within Net Sales. Non-Royalty Income shall include, without limitation, any (i) license signing fee, license issue fee, option fee, maintenance fee, unearned portion of any minimum royalty payment, distribution or joint marketing fee and research and development funding in excess of the cost of performing such research and development, and (ii) consideration received for an equity interest in, extension of credit to, or other investment in Company or Companys Affiliates to the extent such consideration exceeds the fair market value of the equity or other interest received as determined by an independent appraiser mutually agreeable to the Parties, provided, however, that the fees or consideration described in (i) and (ii) are directly attributable to a grant of a sublicense, license, privilege or immunity. For clarity, Non-Royalty Income shall not include consideration received by the Companys stockholders pursuant to the disposition or transfer of all, or substantially all, of the Companys assets, whether by sale, merger, acquisition, operation of law or otherwise.
1.23 Patent Rights means, inclusively, the U.S. Patent [***], U.S. Patent [***], and International Patent Application [***], and/or the equivalent of such applications including any division, continuation (but not including continuation-in-part) and/or any foreign patent application or other rights issuing from, or filed subsequent to the date of this Agreement, based on or claiming priority to or from the applications and rights listed on Appendix A, including continuations (but not continuations in part), divisions, reexaminations, extensions, renewals, supplementary protection certificates, registrations, confirmations, and reissues from such applications and rights, and any patents resulting from any application or right including but not limited to Appendix A.
1.24 Phase 1 Clinical Trial means a human clinical study in any country involving the initial introduction of an investigational new drug into humans, designed to determine the metabolism and pharmacologic actions of Licensed Product for a particular indication or indications in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the United States, Phase 1 Clinical Trial means a human clinical study that satisfies the requirements of 21 C.F.R. §312.21 (a).
1.25 Phase 2 Clinical Trial means a human clinical study in any country conducted to evaluate the effectiveness of Licensed Product for a particular indication or indications in patients with the disease or condition under the study and, possibly, to determine the common short-term side effects and risks associated with the Licensed Product. In the United States, Phase 2 Clinical Trial means a human clinical study that satisfied the requirements of 21 C.F.R. §312.21 (b).
1.26 Pivotal Clinical Trial means an adequate and well-controlled human clinical study, as outlined under 21 C.F.R §314.126 and 21 C.F.R. §312.21 (b) or their foreign equivalents in any Major Market Country, of a Licensed Product or, the results of which are intended to form the final basis for regulatory approval at the time of the commencement of the trial. For avoidance of doubt, a clinical trial that meets the foregoing criteria shall be deemed a Pivotal Clinical Trial regardless of whether it is characterized as a Phase 2b, or Phase 2b/3, or Phase 3.