Regulatory Responsibilities. Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Products including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material *Confidential Treatment Requested. correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.
Appears in 4 contracts
Samples: And Commercialization Agreement, And Commercialization Agreement (Corium International, Inc.), And Commercialization Agreement (Corium International, Inc.)
Regulatory Responsibilities. Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Products Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material *Confidential Treatment Requested. correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.
Appears in 3 contracts
Samples: And Commercialization Agreement (Corium International, Inc.), And Commercialization Agreement (Corium International, Inc.), And Commercialization Agreement (Corium International, Inc.)
