Regulatory Lead Party. BMS shall have sole responsibility for (and bear all costs and expenses associated with) all regulatory activities regarding Products. BMS shall also have sole responsibility for (and bear all costs and expenses associated with) worldwide pharmacovigilance for each Product. BMS and its Affiliates shall have sole responsibility for all pricing and reimbursement approval proceedings relating to any Product in the Territory.
Appears in 3 contracts
Samples: Collaboration Agreement (Exelixis, Inc.), Collaboration Agreement (Exelixis Inc), Collaboration Agreement (Exelixis Inc)
Regulatory Lead Party. BMS shall have sole responsibility for (and bear all costs and expenses associated with) all regulatory activities regarding Products. BMS shall also have sole responsibility for (and bear all costs and expenses associated with) worldwide pharmacovigilance for each such Product. BMS and its Affiliates shall have sole responsibility for all pricing and reimbursement approval proceedings relating to any each Product in the Territory.
Appears in 2 contracts
Samples: License Agreement (Exelixis Inc), License Agreement (Exelixis Inc)