definiens: or means activities that occur after IND filing directly and specifically relating to pre - clinical and clinical drug development of a Product in the Field, including test method development and stabilitytesting, assay development, toxicology, pharmacology, formulation, drug delivery, device or delivery technologydevelopment, quality 7 [ * * * ] Certain information in this document has been omitted and filed separately with the Securities and ExchangeCommission . Confidential treatment has been requested with respect to the omitted portions.assurance/quality control development, technology transfer, statistical analysis, process development and scale - up, pharmacokinetic studies, data collection and management, clinical studies ( including research to design clinicalstudies ), medical affairs for such pre - clinical and clinical activities, regulatory affairs, or clinical trial education andrecruitment activities, project management, drug safety surveillance activities related to clinical studies, studies toassess the viability of developing Product for additional indications in the Field, the preparation, submission andmaintenance of Registration Filings and Regulatory Approvals ( including post - marketing clinical trials imposed byapplicable Law or as required by a Regulatory Authority ) reimbursement and/or listing on health care providers ’ andpayers ’ formularies