“Know-How” shall mean all technical, scientific and other know-how and information, Trade Secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including high-throughput screening and other drug discovery and development technology, pre-clinical and clinical trial results, investigational use information, manufacturing procedures, test procedures and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all improvements, whether to the foregoing or otherwise, and other discoveries, developments, inventions, and other intellectual property (whether or not confidential, proprietary, patented or patentable).
“Law” shall mean any federal, state, local or foreign law, statute, constitution, ordinance, decree, requirement, code, order, judgment, settlement agreement, injunction, restriction, rule or regulation.
“Liability” shall mean any debt, liability, loss, commitment, adverse claim, fine, penalty or obligation of any nature, whether direct or indirect, pecuniary or not, asserted or unasserted, accrued or unaccrued, absolute or contingent, matured or unmatured, liquidated or unliquidated, determined or determinable, incurred or consequential, known or unknown, and whether due or to become due, including those arising under any Contract or Law.
“Licensed Intellectual Property” shall mean the Intellectual Property owned by a Third Party that is licensed by any Seller in the conduct of the Business, excluding Intellectual Property comprising, claiming or covering software or other information technology assets.
“Lioresal” shall mean the Product marketed by Sellers under the brand name Lioresal®, as further described on Schedule 1.1(a) to the Seller Disclosure Letter.
“Loss” or “Losses” shall mean, any and all losses, claims, damages, Liabilities, settlements, judgments, injuries, penalties, awards, reasonable and documented out-of-pocket fees and expenses (including reasonable fees and expenses of counsel), Taxes, costs (including costs of investigation and defense) of any nature, whether or not involving a claim.
“Lyvispah” shall mean the Product developed by Sellers with the brand name Lyvispah®, as further described on Schedule 1.1(a) to the Seller Disclosure Letter.
“Manufacture” and “Manufacturing” shall mean all activities related to the production, manufacture, processing, testing, filling, finishing, packaging, labeling, and shipping and holding (prior to distribution) of the Products or any intermediate thereof, including quality assurance and quality control.
“Manufacturing Documentation” shall mean any and all documentation that is necessary, required by applicable Laws and in the possession of Sellers (or any of their respective Affiliates) for the Manufacture of the Products (or any component thereof), including the following: manufacturing process validation reports; manufacturing instructions; batch record templates; manufacturing standard operating procedures; specifications and test methods for the Products, raw materials and stability; standard operating procedures and specifications for labeling, packaging, manufacturing and packaging instructions; master formula; validation reports (analytical, packaging and cleaning); stability data; and approved supplier lists.
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