Additional Work and Fees. 5.1 The Client will be charged at the Contractor’s standard rate for any additional work carried out by the Contractor that falls outside the scope of the Website Maintenance detailed in Schedule One of this Agreement.
Additional Work and Fees. The Manufacturing Fee described in Section 7.1 is based upon the scope of activities that Xxxxxx plans to undertake in the ordinary course to manufacture and release Product in accordance with the Exhibits hereto, Applicable Laws and the Quality Agreement. The Manufacturing Fee does not cover activities or expenses related to matters that might arise outside the ordinary course of manufacturing and releasing Product in accordance with the Product Specifications, Applicable Laws, Quality Agreement, and other Exhibits. By way of example only, additional work might be required for Product or process changes requested by the Regulating Groups, API source changes or API manufacturing process changes, USP or other regulatory requirements changes, excessive or untimely requests by Cadence for label changes or recalls or other actions by Regulating Groups, or mutually agreed upon expansion of the Territory. Xxxxxx will not be required to perform, nor be entitled to reimbursement for, any such work until the Parties negotiate in good faith and reach written agreement on the scope of the additional work and the related additional expenses. Any such additional work and the related additional expenses shall be set forth in a Development Plan.
Additional Work and Fees. The Manufacturing Fee is based upon the scope of activities that Xxxxxx plans to undertake in the ordinary course to manufacture and release Product in accordance with this Agreement, including without limitations the Product Specifications and other Exhibits, and the Quality Agreement. The Manufacturing Fee does not cover activities or expenses related to matters that might arise outside the ordinary course of manufacturing and releasing Product in accordance with this Agreement and the Quality Agreement. By way of example, additional work might be required for Product or process changes requested by the FDA or other Regulatory Authorities, API source changes or API Manufacturing Process changes, USP or other regulatory requirements changes, excessive or untimely requests by EKR for label changes or recalls or other actions by Regulatory Authorities, or mutually agreed upon expansion of the Territory. Xxxxxx will not be required to perform, nor be entitled to reimbursement for, any such additional work until the Parties reach written agreement on the scope of the additional wok and the related additional expenses.
