definiens: or means, ( a ) activities directly and specifically relating to research, pre - clinical and clinicaldevelopment of a Collaboration Product in the Field, including test method development, assay development, toxicology, pharmacology, formulation, statistical analysis, pharmacokinetic studies, data collection and management, Clinical Trials ( including research to design ClinicalTrials ), regulatory affairs, project management, drug safety surveillance activities related to Clinical Trials, the preparation, submission andobtaining of Regulatory Filings and other Regulatory Documentation ( including Clinical Trials imposed by applicable Law or as required by aRegulatory Authority ( other than Non - Approval Studies ) ) and activities necessary or useful to obtain a Required Pricing Approval, and ( b ) anyother development activities directly and specifically relating to a Collaboration Product in the Field, including activities to support new productformulations, delivery technologies or new indications in the Field for a specific Collaboration Product either before or after the FirstCommercial Sale of such Collaboration Product . For clarity, and shall have a meaning consistent with this definition