definiens: or means, with respect to a Collaboration Product, a ny and all clinical drug development activities and manufactur ing activities undertaken pursuant to the relevant Joint Development Plan in order to develop a Collaboratio n Product up to and including obtaining Regulatory Approval for such Collaboration Product for an indi cation and to perform manufacturing scale up to ena ble commercial scale manufacturing prior to launch ( exc ept that inventory build shall be considered a Commercialization activity ) . These activities shall include preclinical research, stability testing, t oxicology testing, formulation activities, reformulation acti vities, process development, manufacturing scale - up activities, development stage manufacturing, quality assurance/ quality control development, clinical studies ( incl uding Phase III Studies, Phase III - B Studies, Phase IV St udies and other studies ( e.g., pharmacovigilance pr ograms and outcome studies ) that the JSC considers necessary o r economically justifiable ) and other activities to obtain the applicable Regulatory Approvals ; in each case in ac cordance with the applicable Joint Development Plan, as applicable . When used as a verb, means to engage in Development