definiens: or means, with respect to a Collaboration Compound, Candidate Drug orProduct for a Primary Indication, Schizophrenia or a Small Market Indication, all non - clinical and clinical activitiesrequired to obtain Commercialization Regulatory Approval of such Product ( including any Product that contains suchCollaboration Compound or Candidate Drug ) in accordance with this Agreement up to and including the obtaining ofCommercialization Regulatory Approval of such Product for such Primary Indication, Schizophrenia or Small MarketIndication . For purposes of clarity, these activities include 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 Trialdesign and operations, preparing and filing Drug Approval Applications, and all regulatory affairs related to theforegoing . When used as a verb, means to engage in Development and has a correspondingmeaning