definiens: means all development activities for any Product ( o r a Companion Diagnostic for such Product in accordance with this Agreement ) tha t are directed to obtaining Regulatory Approval(s ) of such Product, including : all non - clinical, preclinical a nd clinical activities conducted in support of Regu latory Approval ( including any Required Phase 4 Studies ) ; testing and studies of such Product ( including IND- enabling studies and translational research ) ; toxicology, ph armacokinetic and pharmacological studies ; manufact ure and distribution of such Product for use in Clinical Tr ials ( including comparators, process development an d scale up, and Combination Therapies ) ; statistical analyses ; a ssay development ; instrument design and development ; protocol design and development ; quality assurance and control ; report writing ; the preparation, filin g and prosecution of any MAA for such Product ; developmen t activities directed to label expansion or obtaini ng Regulatory Approval for one or more additional indi cations following initial Regulatory Approval ; heal th economic studies relating to the indication for whi ch the applicable Product is being developed conduc ted prior to Regulatory Approval ; and all regulatory affairs related to any of the foregoing . and have a correlative meaning