Indemnified Party means a Person entitled to indemnification under Article 8.
Indemnifying Party means a Party from whom indemnification is sought under Article 8.
Invention means inventions, Know-How, developments or discoveries, whether patentable or non-patentable.
Joint Collaboration Committee or JCC has the meaning set forth in Section 5.1.1.
Joint Steering Committee or JSC has the meaning set forth in Section 2.6.1.
Know-How means all chemical and biological materials and other tangible materials, inventions, practices, methods, protocols, formulae, knowledge, know-how, trade secrets, processes, procedures, assays, skills, experience, techniques, information, data and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical test data and analytical and quality control data, patentable or otherwise.
Law or Laws means any applicable United States federal, state, or local law, or foreign 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 Authority, 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, including all applicable Anti-Corruption Laws, accounting and recordkeeping laws, and laws relating to interactions with HCPs and Government Officials. For the avoidance of doubt, any specific references to any Applicable Law or any portion thereof shall be deemed to include all then-current amendments thereto or any replacement or successor law, statute, standard, ordinance, code, rule, regulation, resolution, promulgation, order, writ, judgment, injunction, decree, stipulation, ruling, or determination thereto..
Losses means damages, losses, liabilities, costs (including costs of investigation, defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys and experts fees and expenses), in each case resulting from an Action.
Manufacture or Manufacturing means all activities related to the production of the Opted-In Product, including the production of any of the following to the extent used in the Opted-In Product: any drug substance produced in bulk form for use as an active pharmaceutical ingredient, drug product, compounded or finished final packaged and labeled form, and in intermediate states, including the following activities: reference standard preparation, cell bank preparation, mammalian cell production, purification, formulation, scale-up, packaging, quality assurance oversight, quality control testing (including in-process release and stability testing), validation activities directly related to all of the foregoing, and data management and recordkeeping related to all of the foregoing. References to a Person engaging in Manufacturing activities will include having any or all of the foregoing activities performed by a Third Party.
Marketing Authorization means the grant of all necessary final or conditional permits, registrations, authorizations, licenses and approvals (or waivers) required for the importation and Commercialization of the Opted-In Product for use and in the Territory, including any Regulatory Approval for sale or marketing, and, where required, Pricing and Reimbursement Approvals.
Non-Breaching Party has the meaning set forth in Section 9.2.1.
Opt-In Notice has the meaning set forth in Section 2.2.1.
Opt In has the meaning set forth in Section 2.2.2.