Sepracor. Sepracor will indemnify (subject to Section 10.3), defend and hold Lilly harmless against any and all actions, suits, claims, demands, prosecutions, liabilities, costs, and expenses based on or arising out of this Agreement, resulting from Sepracor's activities under this Agreement and activities related to the research and development, manufacture, packaging, use or sale of Products by Sepracor, or use of Sepracor Know-How or Products by Sepracor, its other licensees or its (or their) customers or any representation made or warranty given by Sepracor or its other licensees with respect to Products.
Sepracor. Sepracor represents and warrants that, to the best of Sepracor's knowledge:
Sepracor. Patheon 1 Permit on-site audits of all Patheon premises used in the manufacture of Products, procedures and Product-related documentation by Sepracor. This includes one (1) routine audit per year per site and, as necessary any for cause audits. X 2 Permit access to all appropriate areas of manufacturing by Sepracor for the purpose of observing/monitoring manufacturing, packaging, and in-process/release testing of the Product. X
Sepracor. Patheon 1 Provide the master formula. X 2 Provide approved supplier list from the NDA. X 3 Qualify and approve Active Materials supplier(s). X 4 Provide Active Materials specifications. X 6 Validate testing methods for Active Materials. X 7 Transfer Active Materials methods to Patheon (may be only ID methods). X 8 Participate in protocol driven method transfers in order to receive Active Materials methods (if necessary). X X 10 Maintain retain sample of the Active Materials for one year beyond the expiration of the Product. X X 11 Qualify and approve excipients supplies as per Patheon SOP. X 12 Provide test methods and method validation (or qualification as appropriate) for excipients for non-compendia methods. X 13 Provide specifications and test methods for excipients for all compendia methods for Sepracor approval. X
Sepracor. Patheon 1 Prepare, control, issue and executive master packaging records. (X) X 2 Review and approve master packaging records. X X 3 Provide artwork, dimensions, labeling text and other specifications for Sepracor specific packaging components. X 4 Review and approve labeling. X (X) 5 Provide Sepracor's Technical Information for packaging components. X (X) 8 Provide specification and test methods for packaging components for Sepracor approval. X 9 Analyze packaging components (in accordance with vendor qualification program) and release packaging components. X
Sepracor. Patheon 1 Perform a quality review of batch production records at the manufacturing site. X 2 Document errors, deviations, reworks, investigations, in-process testing investigations, adverse observations, etc found during manufacture or review. X
Sepracor. Sepracor shall use commercially reasonable efforts to pursue diligently development and commercialization of a Muscarinic Product based on each Primary Selected Muscarinic Compound (or one of its Back-Up Selected Muscarinic Compounds), and, if Sepracor has exercised its Option, at least one Fixed Co-Formulation Product, in at least one (1) Major Market and in such other countries and jurisdictions as Sepracor deems commercially reasonable, and to maximize sales of such Products. As used herein, “commercially reasonable efforts” shall mean those efforts, consistent with the exercise of customary scientific and business practices as applied in the pharmaceutical industry for development and commercialization activities conducted with respect to other products of similar potential and market size.
Sepracor. Sepracor, at its own expense, shall maintain product liability insurance (or self-insure) in an amount consistent with industry standards during the Term of the Agreement. Sepracor shall provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to ACADIA upon request.
Sepracor. Sepracor represents and warrants that, to the best of Sepracor’s knowledge as of and after the Commencement Date:
Sepracor. Sepracor Inc., a Delaware corporation and the parent of the Company and Versicor.
