Common use of Underlying Assumptions Clause in Contracts

Underlying Assumptions. The Manufacturing Fees set forth herein are based upon the following key assumptions: (i) The Manufacturing Fees include all labor and Material costs incurred by Baxter (it being understood that Baxter shall incur no costs in connection with the Bulk Active or any other materials, such as package inserts, provided by Guilford) and excludes all applicable sales and value added taxes. (ii) In the event either Guilford or Baxter shall desire to make any change in any label for the Product (including without limitation the bag label, the intermediate carton label and the case label) during the term of this Agreement, the parties shall meet to negotiate the additional costs to be incurred by Baxter, which costs shall be allocated between Guilford and Baxter as set forth in this Section 4.3(ii). With respect to label changes by Guilford, including both discretionary changes and changes required by the FDA or Applicable Law, Guilford may request, and Baxter shall implement [***]. If Guilford shall request (or shall be required by the FDA or Applicable Law to implement) [***], the parties shall meet to negotiate in good faith the additional costs to be incurred by Baxter in connection with such changes, which costs shall be invoiced separately by Baxter to Guilford, and Guilford will pay such amount to Baxter within [***] of invoicing by Baxter. With respect to label changes by Baxter, including both discretionary changes and changes required by the FDA or Applicable Law, Baxter shall bear the cost of such changes. (iii) [***] testing is utilized throughout the Territory. [***] testing, if required, shall be separately paid for by Guilford as set forth in the Quality Agreement.

Underlying Assumptions. The Manufacturing Fees set forth herein are based upon the following key assumptions: (i) The Manufacturing Fees include all labor and Material costs incurred by Baxter (it being understood that Baxter shall incur no costs in connection with the Bulk Active or any other materials, such as package inserts, provided by Guilford) and excludes all applicable sales and value added taxes. (ii) In the event either Guilford or Baxter shall desire to make any change in any label for the Product (including without limitation the bag label, the intermediate carton label and the case label) during the term of this Agreement, the parties shall meet to negotiate the additional costs to be incurred by Baxter, which costs shall be allocated between Guilford and Baxter as set forth in this Section 4.3(ii). With respect to label changes by Guilford, including both discretionary changes and changes required by the FDA or Applicable Law, Guilford may request, and Baxter shall implement [***]. If Guilford shall request (or shall be required by the FDA or Applicable Law to implement) [***], the parties shall meet to negotiate in good faith the additional costs to be incurred by Baxter in connection with such changes, which costs shall be invoiced separately by Baxter to Guilford, and Guilford will pay such amount to Baxter within [***] * of invoicing by Baxter. With respect to label changes by Baxter, including both discretionary changes and changes required by the FDA or Applicable Law, Baxter shall bear the cost of such changes. (iii) [***] testing is utilized throughout the Territory. [***] * testing, if required, shall be separately paid for by Guilford as set forth in the Quality Agreement.