definiens: means, and includes, but is not li mited to, all preclinical, clinical, and other prod uct development, product research or consulting activit ies relating to all aspects required for developmen t of the Royalty Product anywhere in the world ( specifically including any and all regulatory registrations wor ldwide ), which include but are not limited to research, pre- clinical, legal ( including intellectual property ), clinical and regulatory activities, both internal ( billed at the then prevailing hourly rate of the employee ) and e xternal, directed towards obtaining Regulatory Approval of t he Royalty Product, conducting any and all clinical trials of or for Royalty Products, obtaining the Regulatory A pproval of a Royalty Product, and all activities re lating to developing the ability to manufacture API, clinical trial materials, or finished product . This include s, but is not limited to in vitro studies, animal studies, chemic al synthesis, toxicology, pharmacology, test method development and stability testing, formulation, del ivery system development, quality assurance and qua lity control development, manufacturing, statistical ana lysis, pharmacovigilance, clinical studies, regulat ory affairs, manufacturing process development for bulk and fina l forms of API, clinical trial materials, or produc t for commercial distribution, validation documentation, all documentation generated in connection with the manufacturing and/or processing activities and manu facturing and quality assurance technical support a ctivities with respect to clinical trial material or product for commercial distribution