definiens: or shall mean, with respect to a Co -Funded Product, the following activities undertaken or performed for such Co -Funded Product ( following [COMPANY] ’s exercise of the Option for such Co -Funded Product ): ( a ) activities relating to research, pre -clinical and clinical development of such Co - Funded Product, including test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance / quality con trol development, technology transfer, statistical analysis, process development and scale -up, pharmacokinetic studies, data collection and management, clinical studies ( including research to design clinical studies ), regulatory affairs, project management, drug safety surveillance activities related to clinical studies, the preparation submission and maintenance of Registration Filings, but excluding activities necessary to obtain a Pricing Approval, reimbursement and/or listing on health care providers ’ a nd payers ’ formularies and ( b ) any other research and development activities with respect to such Co -Funded Product, including, activities to support the discovery of biomarkers and activities to support new product formulations, delivery technologies and/ or new indications, either before or after the First Commercial Sale