1.28 IND means (a) an Investigational New Drug Application as defined in the FFDCA and applicable regulations promulgated by the FDA, or (b) an equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.
1.29 Indemnify has the meaning set forth in Section 7.1.
1.30 IPO means an underwritten initial public offering of Common Stock of Licensee pursuant to a registration statement on Form S-1, declared effective by the SEC resulting in all outstanding preferred stock in Licensee being converted to common stock.
1.31 Joint Inventions has the meaning set forth in Section 5.1.
1.32 Joint Patents has the meaning set forth in Section 5.1.
1.33 Know-How means any and all commercial, technical, regulatory, scientific and other know-how and information, knowledge, technology, materials, methods, processes, practices, standard operating procedures, formulae, instructions, skills, techniques, procedures, assay protocols, experiences, ideas, technical assistance, designs, drawings, assembly procedures, specifications, regulatory filings, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, regulatory, manufacturing and quality control data and know-how, including study designs and protocols and all data and information used in support of the V134444 IND), whether or not confidential, proprietary or patentable, in written, electronic or any other form.
1.34 Lapsed Patents means the patent applications listed on Exhibit A.
1.35 Licensed Intellectual Property means all Exclusively Licensed Know-How, Non- Exclusively Licensed Know-How and Lapsed Patents.
1.36 Licensed Products means all products incorporating or comprising a Compound, including any and all formulations and for any and all modes of administration.
1.37 Licensor Improvements means all Patents outside the field of pain Controlled by Licensor or its Affiliates at any time during the Term that (a) are necessary for the development, manufacture or commercialization of a Compound as a single agent (b) Cover a method of use of a Compound as a single agent, or (c) Cover a method of delivery, formulation or manufacture of a Compound as a single agent necessary for the development, manufacture or commercialization of a Compound as a single agent.
1.38 Licensor Indemnitees has the meaning set forth in Section 7.1.
1.39 Losses has the meaning set forth in Section 7.1.
1.40 Major Market Country means any of France, Germany, Italy, Spain, and the United Kingdom.
1.41 MHLW means the Ministry for Health, Labor and Welfare in Japan, or any successor agency with similar responsibilities.
1.42 NDA means a new drug application (as such term is used under the FFDCA), a biologic license application (as such term is used under the FFDCA), or other applicable pharmaceutical, biologic, or device approval submission to the FDA for Regulatory Approval (or, in a country other than the United States, the equivalent necessary submissions to the applicable regulatory authority for Regulatory Approval).