definiens: means ( a ) in the United States, written notice or other written evidence of marketing approval by the FDA based on acceptance of an NDA and satisfaction of any related applicable FDA registration and notification requirements ( if any ) and ( b ) outside the United States, written notice or other written evidence of marketing approval by the relevant Regulatory Authority in a particular jurisdiction of a single application or set of applications comparable to an NDA and satisfaction of any related applicable regulatory and notification requirements, if any, together with any other approval necessary to make and sell commercially in such jurisdiction a pharmaceutical or biological therapeutic product including, where necessary or applicable, satisfactory labeling and pricing approval, and, if necessary for commercialization of a phannaceutical or biological therapeutic product, governmental reimbursement approval and/or inclusion on any governmental formularies effective in such jurisdiction ; provided, however, that if the First Commercial Sale in a specific jurisdiction occurs prior to receipt of such pricing or reimbursement approval or inclusion in such formularies for such jurisdiction, then Regulatory Approval will be deemed to have been obtained