definiens: means all activities relating to obtaining Regula tory Approval of a Licensed Product, Licensed Product line extensions, alternative deliv ery systems and new indications therefor, and all activities relating to developing the ability to Ma nufacture the same, including CMC . This includes, f or example, ( i ) non -clinical testin g, toxicology, formulation, clinical studies, regul atory 8 affairs, and outside counsel regulatory legal servi ces, ( ii ) manufacturing process development for bul k and finished forms of Licensed Antibodies and Licen sed Products, and manufacturing and quality assurance technical support activities prior to the First Commercial Sale of a Licensed Product anywhe re in the Territory and ( iii ) the conduct of advisory boards with relevant experts, e.g. clinical experts or payer representatives . Development shall not includ e activities associated with Phase 4 Clinical Trial s in respect of a Licensed Product commenced after First Commercial Sale of such Licensed Product anywhere in the Territory unless ( x ) required or re quested by a Regulatory Health Authority as a condition of obtaining, maintaining or extending Re gulatory Approval or ( y ) performed to explore additional indications or alternative formulations of such Licensed Products