definiens: or means, with respect to a Product, any and all pre -clinical, non- clinical and clinical research and development activities for su ch Product, and that are reasonably related to or l eading to the development, preparation, and submission of data and information to a Comp etent Authority for the purpose of obtaining, supporting or expanding M arketing Approval or to the appropriate body for obtaining, supporting or expanding pricing approval, including all activities related to pharmacokinet ic profiling, design and conduct o f Clinical Studies, those Manufacturing related act ivities that support the Development of the applicable Product ( such as proc ess development, scale up, test method development, formulation development, delivery system developmen t, quality control develop ment, and validation ) and CMC activities, medical affairs, regulatory affairs, statistical analysis, report writing, and regulat ory filing creation and submission ( including the services of outside advisors and consultants in connection therewith )