definiens: or means to engage in research and development activities intended to research, discover or develop Compounds and/or to s upport INDs, NDAs or other Regulatory Approvals for Products, including, without limitation, ( i ) develo pment of the applicable active drug substance(s ), ( ii ) toxicology, pre - clinical and clinical drug dev elopment activities, ( iii ) clinical trials ( except for Phase IV Studies ), ( iv ) assay / test method development, valid ation and stability testing, ( v ) formulation develo pment, ( vi ) manufacture of pre - clinical, clinical and comm ercial supplies, and manufacturing process developm ent, scale - up and validation, ( vii ) quality assurance / qu ality control, statistical analysis, and regulatory affairs ( including without limitation the preparation, subm ission and maintenance of all INDs and NDAs for the Products ), and ( viii ) to have any of the activities described in ( i)-(vii ) performed