Notice of Regulatory Action. EURAND shall provide RELIANT with immediate notification of its receipt of any of the following related to the manufacture, production or testing of Product: a copy of any list of observations (Form FD 483), Warning Letter, Information Letter, Regulatory Letter or the like issued by the FDA as well as provide RELIANT an opportunity to review any written response prior to submission to the issuing agency. However, EURAND maintains sole responsibility for any matter pertaining to such inspections.
Appears in 5 contracts
Samples: License and Supply Agreement (Reliant Pharmaceuticals, Inc.), Development, License and Supply Agreement (Reliant Pharmaceuticals, Inc.), License and Supply Agreement (Reliant Pharmaceuticals, Inc.)
