Additional Development Deliverables. If the Development Deliverables set forth in Exhibit B prove to contain insufficient Information for a Party to carry out its responsibilities under this Agreement, including information required for Cadence to obtain and maintain Regulating Group approval and registration of the Product in the Territory in accordance with Section 5.0 or to complete the FDA’s Annual Report and similar reports required by other Regulating Groups in the Territory, or to obtain patent protection in accordance with Section 14.0, the Parties will in good faith negotiate an amendment of Exhibit B to include as a Deliverable the additional Information or activities which are necessary for such purpose. Such negotiations may arise by mutual consensus of the Parties or following the written request of either Party.
Additional Development Deliverables. If the Development Deliverables from one Party prove to contain insufficient Information for either Party to carry out its responsibilities under this Agreement to obtain and maintain Regulatory Authority approval and registration of the Product in the Territory in accordance with Section 5.0, including information required for EKR to complete the FDA’s Annual Report and similar reports required by other Regulatory Authorities in the Territory, or to obtain patent protection in accordance with Section 13.0, then the Parties will in good faith negotiate an amendment of the Development Plan to include as a new Development Deliverable the additional Information which is necessary to permit the other Party to carry out such Party’s activities under this Agreement.
Additional Development Deliverables. If the Baxter Development Deliverables or the Cadence Development Deliverables set forth in a Development Plan prove to contain insufficient information for a Party to carry out its responsibilities under this Agreement, including information required for Cadence to obtain and maintain Regulating Group approval and registration of the Product in the Territory in accordance with Article 5.0 or to complete the FDA’s Annual Report and similar reports required by other Regulating Groups, or to obtain Patent protection in accordance with Article 14.0, the Parties will in good faith negotiate and execute an Amended and Restated Development Plan to include as a Deliverable the additional information or activities which are necessary for such purpose. Such negotiations may arise by mutual consensus of the Parties or following the written request of either Party. Baxter will not be required to perform, nor be entitled to reimbursement for, any work beyond that described in a Development Plan(s) unless and until the Parties reach written agreement on the scope of any additional work and the related additional expenses (coordinated through the Product Managers under Section 3.1), and an Amended and Restated Development Plan has been executed by both Parties.
