definiens: or means, with respect to Collaboration Products, any and all preclinical and clinicaldrug development activities and manufacturing activities undertaken pursuant to the Initial Collaboration Product Planor an Manufacturing, Preclinical and Clinical Development Plan in order develop a Collaboration Product up to andincluding obtaining Regulatory Approval for such Collaboration Product for an indication and to perform manufacturingscale up to enable commercial scale manufacturing prior to launch ( except that inventory build shall be considered aCommercialization activity ) . These activities shall include preclinical research, stability testing, toxicology testing, formulation activities, reformulation activities, process development, manufacturing scale - up activities, developmentstage manufacturing, quality assurance / quality control development, clinical studies ( including Phase III Studies, other than Phase III - B Studies ) and other activities to obtain the applicable Regulatory Approvals ; in each case inaccordance with the applicable Initial Collaboration Product Plan or Manufacturing, Preclinical and ClinicalDevelopment Plan, as applicable . When used as a verb, means to engage in Development