1.33 “IFRS” means accounting principles as set forth by the International Financial Reporting Standards Foundation, as consistently applied.
1.34 “Improvements” means [***].
1.35 “IND” means an investigational new drug application filed by Licensee with the FDA, or the equivalent application in any foreign jurisdiction filed with another Regulatory Authority.
1.36 “IPO” means the first underwritten, initial public offering of securities of Licensee with gross proceeds of [***]. For purposes of all provisions hereunder that expire, terminate or are otherwise affected by the consummation of an IPO of Licensee, the consummation of an IPO of a Licensee shall cause permanently such expiration, termination or other effect for the Term, and no such provision shall be considered readjusted to its terms prior to such IPO in the event of a subsequent transfer or assignment of this Agreement to a successor Licensee.
1.37 “Indication” means a disease or pathological condition for which clinical results for such disease or condition and a separate NDA application, or a supplement (or other addition) to an existing NDA application, is required for the purpose of obtaining Regulatory Approval in a country. Notwithstanding the foregoing, for purposes of this Agreement, [***].
1.38 “Intellectual Property” means ideas, concepts, discoveries, inventions, developments, Know-How, trade secrets, techniques, methodologies, modifications, innovations, improvements, writings, documentation, electronic code, data and rights (whether or not protectable under state, federal or foreign patent, trademark, copyright or similar laws) or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, and including in each case, all legal rights therein.
1.39 “Know-How” means any and all commercial, technical, regulatory, scientific and other know-how and information, knowledge, technology, tangible 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), whether or not confidential, proprietary or patentable, in written, electronic or any other form.
1.40 “Law” means all laws, statutes, rules, codes, regulations, orders, judgments or ordinances applicable to a Party, this Agreement or the activities contemplated hereunder.
1.41 “Licensed Compounds” means the chemical compound coded by Licensor as [***] as further described on Exhibit A, as well as [***].
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