definiens: means, with respect to a Collaboration Compound, Collaboration Candidate or Licensed Product, all ( a ) non - clinical and pre - clin ical research and development activities and optimi zation completed prior to filing an IND with respect to su ch Collaboration Compound, Collaboration Candidate or Licensed Product, including animal and toxicology s tudies ( ), and ( b ) clinical and non - clinical research and development activities co nducted after filing of an IND with respect to such Collaboration Compound, Collaboration Candidate or Licensed Product, including toxicology, pharmacolog y test method development and stability testing, proc ess development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, Clinical Trials ( other than Phase 4 Clinical Trials ), regulatory affairs, pharm acovigilance, Clinical Trial regulatory activities and obtaining and maintaining Marketing Approval . When used as a verb, or means to engage in Development