Common use of Regulatory Responsibility Clause in Contracts

Regulatory Responsibility. Shire shall have sole and exclusive authority over any regulatory matter relating to the Shire Product, including without limitation, any Shire Product label changes, responding to complaints regarding the Shire Product, reporting on adverse events, handling Shire Product returns and recalls and any communication with any Regulatory Authority. Impax shall promptly inform Shire upon becoming aware of any regulatory issue concerning the Shire Product and shall promptly provide Shire with copies of any correspondence Impax may receive from a Regulatory Authority relating to the Shire Product.