1.46 First Commercial Sale means, with respect to a given Licensed Product and a given jurisdiction, the first commercial sale for monetary value for use or consumption by the end user in an arms length transaction of such Licensed Product to a Third Party in such jurisdiction after Regulatory Approval for such Licensed Product has been obtained in such jurisdiction. First Commercial Sale will not include any distribution or other sale solely for patient assistance, named patient use, compassionate use, or other patient access programs, non-registrational or registrational studies or similar programs or studies, in each case where a Licensed Product is supplied without charge or at the actual Manufacturing cost thereof (without allocation of indirect costs or any markup).
1.47 Global Marketing Guidelines has the meaning set forth in Section 6.5.
1.48 Global Trial means Development activities related to a Clinical Trial for a Licensed Product that are (a) conducted outside the Territory, or both inside and outside the Territory, and (b) are intended to support Regulatory Filings both inside and outside the Territory.
1.49 Global Trial Plan has the meaning set forth in Section 3.3.1.
1.50 Good Clinical Practice or GCP means, in respect of a Clinical Trial, the highest of the then current standards required by Applicable Law of: (a) the European Union, including Directive 2001/20/EC and guidance published by the European Commission or EMA in relation to such Directive; (b) the United States, including the provisions of Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 50, 54, 56, 312, 314, 320, 601 and 610); (c) Japan; (d) the Peoples Republic of China; or (e) such other countries in which a Licensed Product is tested.
1.51 Good Laboratory Practice or GLP means, in respect of laboratory activities, the highest of the then current standards required by Applicable Law of: (a) the European Union, including the Directive 2004/9/EC, Directive 2004/10/EC, guidance published by the European Commission or EMA in relation to such Directives and any local laws, rules and regulations that implement such Directives and guidance; (b) the United States, including the FDAs Good Laboratory Practice regulations at 21 C.F.R. Part 58; (c) Japan; (d) the Peoples Republic of China; or (e) such other countries in which a Licensed Product is tested.
1.53 Indemnification Claim Notice has the meaning set forth in Section 12.3.
1.54 Indemnified Party has the meaning set forth in Section 12.3.
1.55 Information means all knowledge of a technical, scientific, business and other nature, including know-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, Regulatory Data, 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 litres, 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.