Common use of Changes in Project Scope Clause in Contracts

Changes in Project Scope. (a) If Cempra requests changes in the Project or the Product Specifications, or if technical difficulties require that Hospira perform either additional work or repeat work, and such additional work is required not because of Hospira’s breach of this Agreement, fault or negligence, Hospira shall promptly provide Cempra with a new or revised proposal with cost estimates for such changes or additional work including costs for reasonable travel and sustenance, materials and supplies. Hospira will base its cost estimates for such additional work or repeat work at its customary per/hour, per/person rates then in effect, relative to the work to be performed, consistent with its charges to other similarly-situated customers, [*]. If Cempra approves such costs in writing, the applicable changes in the Project or the Product Specifications will be documented in writing and signed by both parties as a change order, and, effective upon such signature, Hospira shall perform such agreed-upon new or additional work, and Cempra shall pay any such agreed-upon costs for such additional work or repeat work performance as set forth in such mutually-executed change order or as otherwise provided in this Agreement. (b) In the event that Cempra decides to have Hospira manufacture Products for development, marketing, and/or sales activities in countries or geographic regions outside of the Territory, Cempra will provide Hospira with reasonable prior written notice of its intent to do so. The parties will then work in good faith to promptly determine the additional work may be required therefor (if any) and upon the parties’ written mutual agreement with respect thereto, Hospira shall provide Cempra with all necessary additional technical/developmental and regulatory support, including, for example, regulatory support for Cempra’s supplemental regulatory filings, packaging and product development, labeling, and relevant Regulatory Authority inspections for such additional country or geographic region outside the Territory. All additional technical/developmental and regulatory support for such other countries or geographic regions shall be considered a change in Project scope and the parties will agree to the reasonable incremental costs of such additional support in accordance with Section 3.3(a). Any additional pre-Regulatory Approval inspections of the Facility that may be requested or required by relevant Regulatory Authorities as a result shall be reimbursed in accordance with Section 7.3(c).