Maintenance of Regulatory Approvals. The Operating Party that owns a Regulatory Approval shall be responsible for filing all reports required to be filed under Applicable Laws in order to maintain any Regulatory Approvals for manufacturing, marketing, and sale of Licensed Products in the Territory, including, without limitation, adverse drug experience reports. Each Operating Party shall cooperate with the other Operating Parties in preparing and filing all such reports and, upon the filing Operating Parties' request, provide the filing Operating Party with any information in the non-filing Operating Party's control which the filing Operating Party deems to be relevant to any such report. Notwithstanding the foregoing, to the extent that any Operating Party has or receives any information regarding any adverse drug experience which may be related to the use of any Licensed Product, that Operating Party shall promptly provide the other Operating Parties with all such information. Promptly after the Effective Date, the Operating Parties shall, as part of the Development Plan, determine the procedures to be followed with respect to reporting adverse drug experiences, such procedures to be consistent with each of the Operating Parties' obligations under Applicable Laws.
Maintenance of Regulatory Approvals. Energy Manager shall have and maintain such Regulatory Approvals as may be necessary or required to provide the Services, including but not limited to obtaining and maintaining (a) CAISO membership, and (b) any applicable FERC authorization to enter into market-based wholesale Power Transactions or Gas Transactions.
Maintenance of Regulatory Approvals. Valera shall use commercially reasonable efforts to maintain the Regulatory Approvals for use, sale and marketing of the Product in each country of the Territory at Valera's sole expense.
Maintenance of Regulatory Approvals. SUMITOMO will, and SUMITOMO will cause any party, which owns the Regulatory Approval of the LdT Drug Product, as appropriate, to, take any and all necessary steps to maintain Regulatory Approval of the LdT Drug Product in each country within the Territory where such approval is obtained.
Maintenance of Regulatory Approvals. Licensee will at its own cost and effort be responsible for Regulatory Maintenance in the Territory, including providing all relevant information and documentation needed as well as payment of any required fees, including for avoidance of doubt the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended), and any other like fees as a result of the sale of Licensed Product in the Territory. Licensor will provide reasonable support as required in a timely manner.
Maintenance of Regulatory Approvals. The Party that owns a Regulatory Approval shall be responsible for filing all reports required to be filed under Applicable Laws in order to maintain any Regulatory Approvals for manufacturing, marketing, and sale of Licensed Products in the Territory, including, without limitation, adverse drug experience reports. Each Party shall cooperate with the other Parties in preparing and filing all such reports and, upon the filing Party's request, provide the filing Party with any information in the non-filing Parties' control which the filing Party deems to be relevant to any such report. Notwithstanding the foregoing, to the extent that any Party has or receives any information regarding any adverse drug experience which may be related to the use of any Licensed Product, that Party shall promptly provide the other Parties with all such information. Promptly after the Effective Date, the Parties shall, as part of the Development Plan, determine the procedures to be followed with respect to reporting adverse drug experiences, such procedures to be consistent with each of the Parties' obligations under Applicable Laws.
Maintenance of Regulatory Approvals. Each Party shall use commercially reasonable efforts to maintain all Regulatory Approvals in its name. Anesta shall perform all actions required on its part to ensure that Elan has all necessary rights under the Regulatory Approvals in Anesta's name to market and sell the OT-fentanyl Products as permitted under this Agreement. Each Party shall provide all reasonable assistance to the other Party as necessary to maintain the Regulatory Approvals in the other Party's
Maintenance of Regulatory Approvals. 16 Section 9.02. Adverse Drug Event Reporting...........................17 Section 9.03. Assistance.............................................17 Section 9.04. Compliance.............................................17 Article X PATENTS AND TRADEMARKS 18
Maintenance of Regulatory Approvals. Altana will own all Regulatory Approvals in the Territory. Altana agrees, at its sole cost and expense, to maintain the Regulatory Approvals including obtaining any variations or renewals thereof, including all fees and licenses, including user fees, related to the Manufacture of the Product by Altana. Each Party agrees that neither it nor its Affiliates will do anything to adversely affect a Regulatory Approval.
Maintenance of Regulatory Approvals. After obtaining Regulatory Approvals for Restylane(R), Perlane(TM), and Restylane Fine Lines(TM), Q-Med shall maintain such Regulatory Approvals in good standing as necessary in order to ensure that the Purchaser receives its own Regulatory Approvals in good standing for Restylane(R), Perlane(TM) and Restylane Fine Lines(TM), as contemplated in Sections 6.2 and 6.3 below.
