definiens: shall mean Net Sales of CVT or any Affiliate or Sublicensee of CVT . ' 1.21 shall mean the conduct of all activities that are reasonably necessary or desirable to identify, research, develop and obtain Regulatory Approval of a Collaboration Compound or Licensed Product or label expansions for a Licensed Product, including but not limited to : ( i ) identification and early pre - clinical testing of compounds, ( ii ) toxicology, regulatory affairs, pre - clinical studies and clinical trials in accordance with the GLPs, GCPs and cGMPs or other designated quality standards and applicable laws and regulations ; and ( iii ) all activities, until such time as manufacturing of Licensed Product intended for commercial sale commences, relating to developing the ability to manufacture Licensed Product, including but not limited to formulation, delivery technologies and devices, scale - up and bulk production, filVfinish, manufacturing process development and validation, and manufacturing and quality assurance technical support . shall mean to engage in Development