definiens: or shall mean ( a ) a ctivities directly and specifically relating to research and pre - clinical and clinical drug deve lopment of a Licensed Product in the Field, includi ng, without limitation, test method development and stability t esting, assay development, toxicology, pharmacology, formulation, quality assurance / quality control deve lopment, technology transfer, statistical analysis, process development and scale - up, pharmacokinetic studies, data collection and management, clinical studies ( i ncluding research to design clinical studies ), regulatory af fairs, project management, drug safety surveillance activities related to clinical studies, the preparation, submi ssion and maintenance of Registration Filings and A pprovals ( including post - marketing clinical trials imposed b y applicable Law and/or as required by a Regulatory Authority ( other than Non - Approval Trials ) ) and act ivities necessary and/or useful to obtain a Pricing Approval, reimbursement and/or listing on health care provide rs ’ and payers ’ formularies, and ( b ) any other deve lopment activities with respect to a Licensed Product in th e Field, including, without limitation, activities to support new product formulations, delivery technologies and/or new indications in the Field whether before or afte r the First Commercial Sale