definiens: or shall mean all preclinical, non -clinical and clinical research and drug development activities conducted by either Party with respect to the Product or the Compound, and shall include, without limitation, all toxicology, pharmacology and other discovery ef forts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, any clinical studies ( but excluding any Phase IV Studi es ), all activities relating to such pre -clinical or clinical studies and/or in connection with seeking and/or obtaining any Regulatory Approval for any New Indication ( but excluding any activities directed to obtaining any Pricing Approvals ) . shall not include any activities that relate to MIOL ’s election ( if any ) to Manufacture and supply Product under Article 9.0, or any activities that relate to Pricing Approvals or Phase IV Studies conducted by CVT or MIOL