definiens: means to research, develop, develop biomarkers, analyze, test, and conduct pre - clinical trials, Clinical Trials ( for clarity, Phase IIIb or Phase IV Clinical Trials and any pre - clinical / clinical / CMC commitments following thereceipt of Regulatory Approval ) and all other regulatory trials ( which conduct may include funding clinical grants or providingsupplies, including comparators ), for any compound or product, as well as any and all activities pertaining to manufacturingdevelopment, formulation development, and the development of manufacturing processes, medical aﬀairs, and lifecyclemanagement ( including the conduct of Phase IIIb or Phase IV Clinical Trial not explicitly for registrational purposes and non - interventional studies ), including new Indications, new formulations, and all other activities ( including regulatory activities)related to supporting, securing, and maintaining Regulatory Approval for any compound or product . Develop will includeManufacturing Development Activities and Analytical Release Testing and Characterization for Licensed Products for use inClinical Trials