1.15 “Field” means any therapeutic or prophylactic application in human (but not animal) health.
1.16 “First Commercial Sale” means, with respect to a Licensed Product in a particular country, the first commercial sale of such Licensed Product in such country after all needed Regulatory Approvals have been obtained in such country.
1.17 “GAAP” means United States generally accepted accounting principles consistently applied.
1.18 “Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.19 “IFRS” means International Financial Reporting Standards, as they exist from time to time, consistently applied.
1.20 “Indication” means any disease or condition which could be listed under the header “INDICATIONS AND USAGE” or described under the header “CLINICAL STUDIES” of a Licensed Product’s label upon Regulatory Approval in the United States, or equivalent thereof.
1.21 “Initiation” of a clinical trial means the first randomization of a subject enrolled in such clinical trial.
1.22 “Information” means all information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge,know-how, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.
1.23 “Knowledge” means, with respect to a Party, the good faith understanding of the facts and information in the possession of an officer of such Party, or anyin-house legal counsel of, orin-house patent agents employed by, such Party or its Affiliates, without any duty to conduct any additional investigation with respect to such facts and information by reason of the execution of this Agreement. For purposes of this definition, an “officer” means any person in the position of vice president, senior vice president, president or chief executive officer of a Party.
1.24 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.
1.25 “Licensed Product” means any pharmaceutical product in any dosage strength or formulation containing a Compound, either alone or in combination with other agents.
1.26 “Major Markets” means [...***...].
1.27 “Manufacturing” means all activities related to Licensed Product manufacture, formulation, processing, filling, finishing, packaging, labeling, inspection, receiving, including holding and shipping of Compound, Licensed Products, or any raw materials or packaging materials with respect thereto, or any intermediate of any of the foregoing, and including process and cost optimization, process development, qualification and validation, equipment and facility qualification and validation,
3