1.37 Force Majeure has the meaning given in Section 11.7.
1.38 GAAP means generally accepted accounting principles, consistently applied, in the jurisdiction applicable to the Person in question.
1.39 GMP means the applicable then-current Good Manufacturing Practice as set forth in: (a) FDA regulations in 21 C.F.R. Parts 210, 211, et., seq. 600 through 680 and the current good tissue practices set forth in 21 C.F.R. Part 1271, (b) in The Rules Governing Medicinal Products in the European Union, Volume IV and (c) the equivalent Laws in any relevant country or jurisdiction, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto, if applicable.
1.40 Governmental Authority means any federal, state, national, regional, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency, board, committee or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).
1.41 Indemnify has the meaning given in Section 9.1.
1.42 Joint Steering Committee or JSC has the meaning given in Section 2.3(a).
1.43 JRA Exception has the meaning given in Section 6.1(e)(ii).
1.44 Know-How means all commercial, technical, scientific and other know-how and information, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, apparatuses, devices, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data and know-how, including regulatory data, study designs and protocols), and Materials, in all cases, whether or not confidential, proprietary, patentable, in written, electronic or any other form now known or hereafter developed, but excluding all Patents
1.45 Knowledge means, with respect to a Party, the actual knowledge, without any duty to conduct any inquiry or investigation, with respect to such facts and information of any senior management-level employees of such Party who were directly involved in the negotiation of this Agreement with the other Party or any member of such Partys senior management.
1.46 Law means any federal, state, local, foreign, multinational, or supranational law, statute, ordinance, code, rule, regulation, resolution, or order of any government authority in the Territory, or any similar provision having the force or effect of law.