definiens: means, with respect to the [COMPANY] Product, any and all activities relating to discovery, research and development in connection with seeking, obtaining or maintaining a ny Regulatory Approval for the [COMPANY] Product, incl uding all pre - clinical research and development act ivities, all pre - marketing human clinical studies ( including clinical trial design and operations ), test method development and stability testing, regulatory toxicology studie s, formulation, all activities relating to developi ng the ability to manufacture the [COMPANY] Product or any component or intermediate thereof ( including process developm ent, manufacturing scale - up, development - stage manufactu ring and quality assurance / quality control developm ent ), statistical analysis and report writing, preparing and filing Drug Approval Applications, reporting of adverse events in clinical study subjects, and all regulatory affa irs related to the foregoing . When used as a verb, or means to engage in Development and has a corresponding meaning