definiens: or shall mean ( a ) with respect toREGN2810, the following activities undertaken or performed from and after the Effective Date, and ( b ) with respect to all other IO Licensed Products, the following activities undertaken orperformed after such IO Licensed Product first becomes an IO Licensed Product hereunder : ( i)activities relating to research, pre - clinical and clinical drug development of such IO LicensedProduct in the Field, including, test method development and stability testing, assaydevelopment, toxicology, pharmacology, formulation, quality assurance / quality controldevelopment, technology transfer, statistical analysis, process development and scale - up, pharmacokinetic studies, data collection and management, clinical studies ( including research todesign clinical studies ), regulatory affairs, project management, drug safety surveillance activitiesrelated to clinical studies, the preparation and submission of Registration Filings but excludingactivities necessary to obtain a Pricing Approval, reimbursement or listing on health careproviders ’ and payers ’ formularies, ( ii ) [ * * * ], ( iii ) the development of companion diagnostics foruse with such IO Licensed Product, and ( iv ) any other research and development activities withrespect to such IO Licensed Product in the Field, including, activities to support the discovery ofbiomarkers and activities to support new product formulations, delivery technologies or newindications in the Field, either before or after the First Commercial Sale