1.1.82 “IND” means an investigational new drug application, Clinical Trial application, Clinical Trial exemption, or similar application or submission filed with or submitted to a Regulatory Authority in a jurisdiction that is necessary to initiate human clinical testing of a pharmaceutical product in such jurisdiction, including any such application filed with the FDA pursuant to 21 C.F.R. Part 312, as well as all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
1.1.83 “Indebtedness” means (a) indebtedness for borrowed money or the deferred price of property or services (excluding any trade accounts incurred in the ordinary course of business), such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations (as such term is understood under GAAP as in effect on the date of this Agreement; it being agreed that all obligations of any Person that are or would have been treated as operating leases for purposes of GAAP prior to adoption of changes described by ASC Topic 842 shall continue to be accounted for as operating leases (and not be treated as or to be recharacterized as capital lease obligations)) and (d) Contingent Obligations; provided that obligations to make revenue interest payments or in respect of royalties with respect to products other than the Product, in each case that are not secured (other than customary back-up securities interests in the case of a sale of revenues or royalties) and that are not guaranteed in amount are not Indebtedness.
1.1.84 “Indemnification Claim Notice” has the meaning ascribed to such term in Section 11.2.1.
1.1.85 “Indemnified Party” has the meaning ascribed to such term in Section 11.2.1.
1.1.86 “Indemnifying Party” has the meaning ascribed to such term in Section 11.2.1.
1.1.87 “Indication” means the treatment of primary biliary cholangitis, or, in the case of a change to the Indication approved by the ERC in accordance with the terms of this Agreement, such other indication.
1.1.88 “Information” means technical or scientific know-how, trade secrets, methods, processes, formulae, designs, specifications and data, including biological, chemical, pharmacological, toxicological, pre-clinical, clinical, safety, manufacturing and quality control data and assays; in each case, whether or not confidential, proprietary, patented or patentable.
1.1.89 “Intellectual Property” means all intellectual property and intellectual property rights of any kind or nature throughout the world, including all U.S. and foreign, (a) Patents; (b) Trademarks; (c) Copyrights; (d) rights in computer programs (whether in source code, object code, or other form), algorithms, databases, compilations and data, technology supporting the foregoing, and all documentation, including user manuals and training materials, related to any of the foregoing; (e) trade secrets and all other confidential information, know-how, inventions, proprietary processes, formulae, models, and methodologies; (f) rights of publicity, privacy, and rights to personal information; (g) all rights in the foregoing and in other similar intangible assets; and (h) all applications and registrations for the foregoing.
1.1.90 “Intellectual Property Security Agreement” means the Intellectual Property Security Agreement between CymaBay and Abingworth dated as of the Effective Date.
-9-