“Governmental Authorization” shall mean, other than a Registration, any approval, consent, ratification, waiver, license, permit, registration or other authorization issued or granted by any Governmental Body which relates to the Company’s business.
“Governmental Body” shall mean any (a) nation, region, state, provincial, county, city, town, village, district or other jurisdiction, (b) federal, state, provincial, local, municipal, foreign or other government, (c) governmental or quasi-Governmental Body of any nature (including any governmental agency, branch, department or other entity and any court or other tribunal), (d) multinational organization exercising judicial, legislative or regulatory power or (e) body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power of any nature of any federal, state, provincial local, municipal, foreign or other government.
“Gross Sales” shall mean the gross amount invoiced or otherwise recorded for Commercial Sale of the Product determined in accordance with IFRS or GAAP, as used by Purchaser, its Affiliates or Sublicensees, as applicable, from time to time.
“Hazardous Substance” shall mean any pollutant, contaminant, chemical, substance, material or waste that is regulated by any Governmental Body, including any pollutant, contaminant, chemical, material, substance or waste that is defined as a “solid waste,” “hazardous waste,” “hazardous material,” “hazardous substance,” “extremely hazardous waste,” “special waste,” “contaminant,” “toxic waste,” or “toxic substance” under any provision of applicable Environmental Law, and also including petroleum and petroleum products, asbestos and asbestos-containing materials, and polychlorinated biphenyls.
“Healthcare Regulatory Authority” shall mean any Governmental Body with jurisdiction over (a) the development, marketing, labeling, packaging, sale, import, export, use, handling and control, safety, efficacy, reliability, manufacturing, approval, or licensing of any drug, device or combination drug/device product, (b) federal healthcare programs under which such drugs, devices and combination drug/device products are purchased or reimbursed or (c) the protection of personal health information, including the FDA.
“HIPAA” shall have the meaning set forth inSection 2.14(b) of the Agreement.
“IFRS” shall mean the International Financial Reporting Standards as used by Medexus Pharmaceuticals Inc. in the preparation of its audited financial statements.
“Indebtedness” shall mean, as applied to any Person: (a) all indebtedness for borrowed money, whether current or long-term or secured or unsecured; (b) all indebtedness for the deferred purchase price of property or services represented by a note or other security; (c) all indebtedness created or arising under any conditional sale or other title retention agreement with respect to property acquired (even though the rights and remedies of the seller or lender under such agreement in the event of default are limited to repossession or sale of such property); (d) all indebtedness secured by a purchase money mortgage or other lien to secure all or part of the purchase price of property subject to such mortgage or lien; (e) all obligations under leases that have been or should be, in accordance with GAAP, recorded as capital leases in respect of which such Person is liable as lessee; (f) any outstanding liability in respect of bankers’ acceptances or letters of credit, including any reimbursement obligations with respect thereto; (g) all interest,
Exhibit A – Page 7