1.60 “Generic Product”means, with respect to a Licensed Product, any product that (a) is sold by a Third Party that is not a licensee or Sublicensee of AbbVie or its Affiliates, or any of their licensees or Sublicensees, under a Drug Approval Application granted by a Regulatory Authority to a Third Party; (b) contains the Licensed Compound as an active ingredient; and (c) is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulatory Authority.
1.61 “IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
1.62 “Indemnification Claim Notice”has the meaning set forth inSection 10.3.
1.63 “Indemnified Party”has the meaning set forth inSection 10.3.
1.64 “Indirect Taxes” has the meaning set forth inSection 6.11.
1.65 “Information” means all technical, scientific, business and other information, includingknow-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical,pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed.
1.66 “Initial Licensed Product” means a Licensed Product for which a milestone payment under any ofSections 6.2.1,6.2.2,6.2.3,6.2.4,6.4.1,6.4.2 or6.4.3 is first received for such Licensed Product.
1.67 “Initiation” or “Initiate” means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study.
1.68 “Intellectual Property” has the meaning set forth inSection 11.5.1.
1.69 “Joint Governance Committee”or“JGC” has the meaning set forth inSection 2.1.1.
1.70 “Joint Intellectual Property Rights”means the collective reference to JointKnow-How and Joint Patents.
1.71 “Joint Inventions” has the meaning set forth inSection 7.1.2.
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[ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.