Exchange of Drug Safety Requests. The Parties shall immediately provide each other with copies of all drug safety requests from all governmental and other regulatory health authorities. Proposed answers affecting the Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers. SAVIENT shall have the ultimate decision-making authority with respect to the answers relating to the Product. The Parties shall exchange decisions from applicable health authorities immediately.
Appears in 5 contracts
Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)
Exchange of Drug Safety Requests. The Parties shall immediately provide each other with copies of all drug safety requests from all governmental and other regulatory health authoritiesRegulatory Authorities. Proposed answers affecting the a Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers. SAVIENT ; provided, however, that Osiris shall have the ultimate decision-making authority with respect to the answers relating to the a Product, unless Law require otherwise. The Parties shall exchange decisions received from applicable health authorities immediatelyRegulatory Authorities reasonably promptly after a Party receives notice of such decision.
Appears in 2 contracts
Samples: Contract Manufacturing Agreement (Osiris Therapeutics, Inc.), Development Agreement (Osiris Therapeutics, Inc.)
Exchange of Drug Safety Requests. The Parties shall immediately provide each other with copies of all drug safety requests from all governmental and other regulatory health authorities. Proposed answers affecting the Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers. SAVIENT shall ***Confidential Treatment Requested have the ultimate decision-making authority with respect to the answers relating to the Product. The Parties shall exchange decisions from applicable health authorities immediately.
Appears in 1 contract
Exchange of Drug Safety Requests. The Parties shall immediately provide each other with copies of all drug safety requests from all governmental and other regulatory health authoritiesmade by any Regulatory Agency regarding a Product. Proposed answers affecting the Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers. SAVIENT ; provided, however, that the IND holder shall have the ultimate decision-making authority with respect to the answers relating to the Product, unless Legal Requirements require otherwise. The Parties shall exchange decisions received from applicable health authorities immediatelyRegulatory Agency reasonably promptly after a Party receives notice of such decision.
Appears in 1 contract
Samples: Co Development and Commercialization Agreement (Maxygen Inc)