“Hazardous Materials” means any waste, material, or substance that is listed, regulated or defined under any Environmental Law, including any pollutant, contaminant, pesticides, chemical substance, hazardous substance, hazardous waste, special waste, solid waste, asbestos, mold, radioactive or toxic material, polychlorinated biphenyls, petroleum or petroleum-derived substance or waste;
“Health Authority” means the Governmental Authorities which administer Health Laws including the FDA, the European Medicines Agency (EMA) and other equivalent agencies in any jurisdiction;
“Health Law” means any Law of any Governmental Authority (including multi-country organisations) the purpose of which is to ensure the safety, efficacy and quality of medicinal and pharmaceutical products and devices (and drug-device combinations) by regulating the research, development, manufacturing, processing, importation, exportation, marketing, advertising, labelling, storage, pricing and distribution of these products, including applicable Law relating to good laboratory practices, good clinical practices, investigational use, product marketing authorisation, manufacturing facilities compliance and approval, good manufacturing practices, labelling, advertising, promotional practices, safety surveillance, record keeping and filing of required reports;
“HIPAA” means, collectively, the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), including its implementing rules and regulations with respect to privacy, security of health information, and transactions and code sets as set forth at 45 CFR Parts 160 and 164;
“Hogan Lovells” means Hogan Lovells International LLP;
“Import and Export Control Laws” has the meaning given to it in Clause 11.1.13(d);
“Indebtedness” means any and all (a) indebtedness or other obligation for borrowed money, whether current or funded, secured or unsecured, including if evidenced by notes, bonds, debentures or other similar instruments (and including all outstanding principal, prepayment premiums and penalties, if any, and accrued interest, breakage, charges, fees and expenses related thereto), (b) the face amounts of letters of credit, (c) cash overdrafts, (d) obligations in respect of interest rate, currency or commodity swaps, collars, caps, hedges, futures Contracts, forward Contracts, options or other derivative instruments or arrangements, (e) obligations under conditional sale, title retention or similar agreements or arrangements creating an obligation with respect to the deferred purchase price of property, services, securities or assets with respect to which the Company Group is liable, primarily or secondarily, absolutely, contingently or otherwise, including all Company Group notes and “earn-out” or milestone payments, (f) any Liability secured by a Lien on the Company Group’s assets or properties, (g) capitalised lease obligations, and (h) outstanding guarantees of obligations of the type described in clauses (a) through (c) and (f) above;
“Indicative Timetable” means the indicative timetable set out in Schedule III;
“Intellectual Property Rights” means all rights, title, and interests in and to all intellectual property rights of every kind and nature however denominated, throughout the world, including: (a) patents, patent applications, invention disclosures, and all related continuations, continuations-in-part, divisionals, reissues, re-examinations, substitutions, and extensions thereof, (b) trademarks, service marks, names, corporate names, trade names, domain names, logos, slogans, trade dress, design rights, and other similar designations of source or origin, together with the goodwill symbolised by any of the foregoing, (c) copyrights and copyrightable subject matter (“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, ideas, know-how, inventions, proprietary processes, formulae, models, and methodologies (“Trade Secrets”), (f) rights of publicity, privacy, and rights to personal information, (g) moral rights and rights of attribution and integrity, (h) domain names and social media accounts and handles, (i) all applications and registrations for the foregoing, and (j) all rights and remedies against past, present, and future infringement, misappropriation, or other violation thereof;
“Internal Revenue Code” means the U.S. Internal Revenue Code of 1986, as amended;
“Intervening Event” means any material Change first occurring or arising after the date of this Agreement if and only if such event, development or change in circumstances was neither known by the Company