Common use of Regulatory Obligations Clause in Contracts

Regulatory Obligations. The Product Party shall be solely responsible for all activities in connection with the Regulatory Approvals for its Products in the Territory, including without limitation communicating and preparing and filing all reports (including without limitation adverse drug experience reports) with the FDA. The non-Product Party agrees to cooperate with the Product Party as requested, at the Product Party’s expense, in preparing and filing all such reports. The Product Party shall pay all fees associated with obtaining and maintaining the Regulatory Approvals including, without limitation, any establishment license fees of such Product Party or Third Parties which must be paid with respect to facilities used in the manufacture of its Products.

Regulatory Obligations. The Product Each Party shall be solely responsible for all activities in connection with the Regulatory Approvals for its Products their respective Product Line in the Territory, including without limitation communicating and preparing and filing all reports (including without limitation adverse drug experience medical device reports) with the FDA. The non-Product Each Party agrees to cooperate with the Product other Party as requested, at the Product requesting Party’s expense, in preparing and filing all such reports. The Product Each Party shall pay all fees associated with obtaining and maintaining the Regulatory Approvals relating to its Product Line including, without limitation, any establishment license fees of such Product Party or Third Parties which must be paid with respect to facilities used in the manufacture of its Productssuch Product Line.