Regulatory Cooperation. Each Party shall inform the other Party within twenty four (24) hours of its receipt of any information that: (i) raises any concern regarding the safety of Compound or Product; (ii) concerns suspected or actual tampering, counterfeiting or contamination or other similar problems with respect to Compound or Product; (iii) is reasonably likely to lead to a Recall or market withdrawal of a Product; or (iv) concerns any ongoing or potential investigation, inspection, detention, seizure or injunction by a Regulatory Authority involving a Compound or Product.
Appears in 4 contracts
Samples: License Agreement (Braeburn Pharmaceuticals, Inc.), License Agreement (Braeburn Pharmaceuticals, Inc.), License Agreement (Titan Pharmaceuticals Inc)
Regulatory Cooperation. Each Party shall inform the other Party Party, within twenty four two (242) hours Business Days, of its receipt of any information that: (ia) raises any material concern regarding the safety or efficacy of Compound or Product; (iib) concerns suspected or actual tampering, counterfeiting Product tampering or contamination or other similar problems with respect to Compound or Product; (iiic) is reasonably likely to lead to a Recall recall or market withdrawal of a Product; or (ivd) concerns any ongoing or potential Regulatory Authority investigation, inspection, detention, seizure or injunction by a Regulatory Authority involving a Compound or Product.
Appears in 2 contracts
Samples: License and Supply Agreement, License and Supply Agreement (Indevus Pharmaceuticals Inc)