definiens: means ( i ) Drug Approval and all other approvals n ecessary for the commercial sale of Licensed Product or Reference Pr oduct ( as the context admits ) in a given country or regulatory jurisdiction ; ( ii ) Pricing Approval ( but only in th ose countries or regulatory jurisdictions where Pri cing Approval is required by Applicable Law for commercial sale ) ; ( iii ) Reimbursement Approval, but only in those co untries or regulatory jurisdictions where Reimbursement Approv al is required for the price paid for Licensed Prod uct or Reference Product ( as the context admits ) to be rei mbursed by a Governmental Authority or a Non - Govern mental Authority with the authority to approve reimburseme nt ; ( iv ) pre- and post - approval marketing authoriza tions ( including any prerequisite Manufacturing approval or authorization related thereto ) and ( v ) labeling approval