1.46“Good Manufacturing Practice”or “GMP”means the current good manufacturing practices applicable from time to time to the manufacturing of a SHP2 Inhibitor, Product or any intermediate thereof pursuant to Applicable Law.
1.47“Governmental Authority”means any multi-national, federal, national, state, provincial, local, municipal or other government authority of any nature (including any governmental division, subdivision, commission, department, bureau, prefecture, agency, branch, office, governmental arbitrator or arbitral body, council, court or other tribunal entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power).
1.48“IFRS”means the International Financial Reporting Standards.
1.49“Immuno-Oncology Agent”means any treatment [***]. For clarity, Immuno-Oncology Agent shall include any treatment that primarily targets [***].
1.50“IND”means (a) in the United States, an Investigational New Drug Application, as defined in the Act, that is required to be filed with the FDA before conducting a Clinical Trial (includingall supplements and amendments that may be filed with respect to the foregoing); and (b) any foreign counterpart of the foregoing filed with a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.51“Indication”means a type of cancer for which Regulatory Approval for a Product is being sought that (i) is distinct from other types of cancer by [***].
1.52“Initial R&D Term”means the first [***] of the Term.
1.53“Initiation”means, with respect to a Clinical Trial of a Product, [***] subject for such Clinical Trial.
1.54“Joint Program Patents”means any Patent Right covering or claiming the Joint ProgramKnow-How.
1.55“Joint Program Technology”means Joint ProgramKnow-How and Joint Program Patents.
1.56“Knowledge”means, with respect to a Party, the actual knowledge of such Party, or what such Party should have known after due inquiry.
1.57“Know-How”means any information and materials, including but not limited to discoveries, inventory, information, regulatory filings, processes, formulae, data, databases, protocols, inventions (whether patentable or not), improvements (whether patentable or not), invention disclosures, developments, skills, experience,know-how and trade secrets (whether patentable or not), including without limitation, all chemical, pharmaceutical, toxicological, biochemical, and biological, technical andnon-technical data, and information relating to the results of tests, assays, methods, techniques, and processes, and specifications or other documents containing information and related data, and any preclinical, clinical, assay control, manufacturing, regulatory and any other data or information, but excluding any Patent Rights.
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