definiens: or means, with respect to each Optimized Lead Compound and Development Candidate(including without limitation any Co - Developed Development Candidate ), all non - clinical and clinical activities performed inorder to obtain Regulatory Approval of a Product ( including without limitation any Co - Developed Product ) Derived fromsuch Optimized Lead Compound or Development Candidate in accordance with this Agreement up to and including theobtaining of Commercialization Regulatory Approval of such Product . For purposes of clarity, these activities include, without limitation, in vivo animal efficacy testing, preclinical safety testing, test method development and stability testing, regulatory toxicology 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