Common use of Regulatory Cooperation Clause in Contracts

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)

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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)

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