Notice of Regulatory Action. ASL shall provide Reliant with immediate notification of its receipt of any of the following related to the manufacture, production or testing storage of the Active Ingredient; a copy of any list of observations (Form FD483), Warning Letters, Information Letters, Regulatory Letters or the like issued by the FDA as well as provide Reliant an opportunity to review any written response prior to submission to the FDA. ASL shall maintain sole responsibility for any matter pertaining to such inspections.
Appears in 5 contracts
Samples: Supply Agreement (Reliant Pharmaceuticals, Inc.), Supply Agreement (Reliant Pharmaceuticals, Inc.), Supply Agreement (Reliant Pharmaceuticals, Inc.)
