[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.39 Indemnified Party has the meaning set forth in Section 9.3(a).
1.40 Indemnifying Party has the meaning set forth in Section 9.3(a).
1.41 Invoicing Entity has the meaning set forth in Section 1.53.
1.42 Know-How means know-how, trade secrets, chemical and biological materials, formulations, protocols, assays, formulations, methods, inventions, discoveries, information, documents, studies, results, data and regulatory approvals, data, filings and correspondence (including Drug Master Files), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable.
1.43 Law or Laws means any federal, state, provincial, local, international or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Body, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.
1.44 Licensed Know-How means Teva Know-How that is not included in the Assigned Assets, including without limitation the Teva Know-How listed in Schedule 6.
1.45 Licensed Patents means the Teva Licensed Patents and Third Party Patents.
1.46 Lien means any lien, pledge, mortgage, deed of trust, security interest, charge, claim, easement, encroachment or other similar encumbrance.
1.47 MAA means (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in any country of the EU if the centralized EMA filing procedure is not used, or (b) any other equivalent or related regulatory submission, in either case to gain approval to market a Product in any country in the European Union, in each case including, for clarity, amendments thereto and supplemental applications.
1.48 Major European Country means any of the United Kingdom, France, Germany, Italy or Spain.
1.49 Manufacture or Manufacturing means activities related to the manufacture, formulation and packaging of any compound or product, including any Compound and Products, including related quality control and quality assurance activities.
1.50 Master Services Agreement means the Master Services Agreement between the parties dated even date herewith.