Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. Following the approval by the FDA of an ANDA, ▇▇▇▇ shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, ▇▇▇▇ shall be responsible for all adverse event reporting as required by the Act. ▇▇▇▇ agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. ▇▇▇▇ shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

Regulatory Responsibilities. Following the approval by the FDA of an ANDA, ▇▇▇▇ shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product Products including any necessary periodic reporting requirements. Furthermore, ▇▇▇▇ shall be responsible for all adverse event reporting as required by the Act. ▇▇▇▇ agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. ▇▇▇▇ shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

Regulatory Responsibilities. Following the approval by the FDA of an ANDA, ▇▇▇▇ shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product Products including any necessary periodic reporting requirements. Furthermore, ▇▇▇▇ shall be responsible for all adverse event reporting as required by the Act. ▇▇▇▇ agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. ▇▇▇▇ 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.