definiens: shall mean all written governmental approvals excluding any price and/or reimbursement approval required for the legal marketing of Licensed Product in the Territory ( e.g., approval by the United Kingdom Medicines Control Agency or by other equivalent government or supranational aqencies in a the Territory that regulates, licenses or otherwise approves the import, manufacture, promotion and/or sale of pharmaceutical 8 • ( ( 1]]FIIEDG:(89364.EXlO_16J00009.PIP ( [ 1 ] ] CENTAIJi P!AIMA EOOAl only FOD ! S - l EnG : 2 - JUL-1998 10:06 BLK : 00·000 - 0000 00:00 1.1 . DODnelley ( 415 ) 845 - 6600 WP2EDG < PAGE > 31, October 1996 products in that country )