definiens: means, and includes, but is not limited to, all preclinical, clinical, and other product development, product research or consulting activities relating to all aspects required for development of the Royalty Product anywhere inthe world ( specifically including any and all regulatory registrations worldwide ), which include but are not limited to research, pre - clinical, legal ( including intellectual property ), clinical and regulatory activities, both internal ( billed at the thenprevailing hourly rate of the employee ) and external, directed towards obtaining Regulatory Approval of the Royalty Product, conducting any and all clinical trials of or for Royalty Products, obtaining the Regulatory Approval of a Royalty Product, andall activities relating to developing the ability to manufacture API, clinical trial materials, or finished product . This includes, but is not limited to in vitro studies, animal studies, chemical synthesis, toxicology, pharmacology, test method developmentand stability testing, formulation, delivery system development, quality assurance and quality control development, manufacturing, statistical analysis, pharmacovigilance, clinical studies, regulatory affairs, manufacturing process developmentfor bulk and final forms of API, clinical trial materials, or product for commercial distribution, validation documentation, alldocumentation generated in connection with the manufacturing and/or processing activities and manufacturing and qualityassurance technical support activities with respect to clinical trial material or product for commercial distribution