definiens: or means, with respect to each Optimized Lead Compound and Development Candidate, all non - clinical and clinical activities performed in order to obtain Regulatory Approval of a Product Derived from suchOptimized Lead Compound or Development Candidate in accordance with this Agreement up to and including the obtainingof Commercialization Regulatory Approval of such Product . For purposes of clarity, these activities include, withoutlimitation, in vivo animal efficacy testing, preclinical safety testing, test method development and stability testing, regulatorytoxicology studies, formulation, process development, manufacturing, manufacturing scale - up, development - stagemanufacturing, quality assurance / quality control development, statistical analysis and report writing, clinical trial design andoperations, preparing and filing Drug Approval Applications, and all regulatory affairs related to the foregoing . When used asa verb, means to engage in Development and has a corresponding meaning