definiens: means, with respect to the Licensed Product or th e [COMPANY] Product, as applicable, any and all activities relating to disc overy, research and development in connection with seeking, obtaining or maintaining any Regulatory Approval fo r the Licensed Product or the [COMPANY] Product, as applicable, in the Territory, including all pre - cli nical research and development activities, all pre- marketing human clinical studies ( including clinical trial design a nd operations ), test method development and stabili ty testing, regulatory toxicology studies, formulation, all act ivities relating to developing the ability to manuf acture the Licensed Product or the [COMPANY] Product, as appli cable, or any component or intermediate thereof ( in cluding process development, manufacturing scale - up, develo pment - stage manufacturing and quality assurance / qua lity control development ), statistical analysis and repo rt writing, preparing and filing Drug Approval Appl ications, reporting of adverse events in clinical study subje cts, and all regulatory affairs related to the fore going . When used as a verb, and mean to engag e in Development and and have the corresponding meaning