Changes to Manufacturing Process, Specifications, Etc. PRONOVA shall not make any changes to the Specifications or to any aspect of its manufacturing or testing process or procedures, API formulation or similar matters that, under 21 CFR Section 314.70, require prior FDA approval or a submission to FDA at the time of the change, unless PRONOVA shall have first provided RELIANT with written notice thereof and provided RELIANT with such information related thereto as RELIANT shall reasonably request in order that RELIANT may evaluate and prepare for the regulatory implications of such change (e.g., additional stability, clinical studies, etc.), and RELIANT shall have approved such change, such approval not to be unreasonably withheld, delayed or conditioned. Notwithstanding anything herein to the contrary, PRONOVA shall provide written notice to RELIANT of any changes to the Specifications or to any aspect of its manufacturing or testing process or procedures, API formulation or similar matters (regardless of whether RELIANT has a consent right under this Section 3.8 in respect thereof) prior to implementing such changes or as soon as practicable thereafter.
Appears in 5 contracts
Samples: Agreement (Reliant Pharmaceuticals, Inc.), Agreement (Reliant Pharmaceuticals, Inc.), Agreement (Reliant Pharmaceuticals, Inc.)
