definiens: or means all development activities for any Product ( or a companiondiagnostic for such Product in accordance with this Agreement ) that are directed to * Confidential Information, indicated by [ * * * ], has been omitted from this filing and filed separately with the Securitiesand Exchange Commission 5Confidential Execution Version obtaining Regulatory Approval(s ) of such Product, including : all non - clinical, preclinical and clinical activitiesconducted in support of Regulatory Approval ( including any Required Phase 4 Studies ) ; testing and studies of suchProduct ( including IND - enabling studies and translational research ) ; manufacturing development, process andformulation development ; toxicology, pharmacokinetic and pharmacological studies ; manufacture and distribution ofsuch Product for use in clinical trials ( including placebos and comparators ) ; statistical analyses ; assay development;instrument design and development ; protocol design and development ; quality assurance and control ; report writing;the preparation, filing and prosecution of any MAA for such Product ; development activities directed to labelexpansion and/or obtaining Regulatory Approval for one or more additional indications following initial RegulatoryApproval ; health economic studies relating to the indication for which the applicable Product is being developedconducted prior to Regulatory Approval ; and all regulatory affairs related to any of the foregoing