definiens: means, with respect to a product, any and all development activities, including, to theextent applicable, use, electrical and mechanical design, chemistry and materials development, software andfirmware development, [ * * * ] development and scale - up, design and process verification and validation, test methoddevelopment, biocompatibility and toxicology, quality assurance / quality control development, statistical analysis, primary packaging development, [ * * * ] in support of Regulatory Approvals,-3- [ * * * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BYBRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIESAND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF1934, AS AMENDED . CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THEOMITTED INFORMATION