Pharmacovigilance. 4.11.1 Each party shall maintain an effective system for the review, evaluation and reporting of Product complaints and adverse drug experiences, as defined in 21 C.F.R. § 314.80(a) and as required under applicable law and in accordance with the Quality Agreement.
Appears in 5 contracts
Samples: Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.), Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.), Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.)
Pharmacovigilance. 4.11.1 3.2.1 Each party shall maintain an effective system for the review, evaluation and reporting of Product complaints and adverse drug experiences, as defined in 21 C.F.R. § 314.80(a) and as required under applicable law and in accordance with the Quality Agreement.
Appears in 4 contracts
Samples: Exclusive Sales and Marketing Agreement (Eton Pharmaceuticals, Inc.), Exclusive Sales and Marketing Agreement (Eton Pharmaceuticals, Inc.), Exclusive Sales and Marketing Agreement (Eton Pharmaceuticals, Inc.)
