Changes in Project Scope. (a) If Theravance 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 fault or negligence, Hospira shall within [***] Business Days provide Theravance with a new or revised proposal with cost estimates for such changes or additional work, based on its customary per/hour, per/person rates relative to the work to be performed, including costs for reasonable travel and sustenance, materials and supplies. If Theravance approves such costs, the mutually agreeable changes will be documented in writing and signed by both parties as a change order, and Hospira shall perform such agreed-upon new or additional work. Theravance shall pay Hospira’s costs for such additional work or repeat work performance as set forth in this Agreement.
(b) In the event that Theravance decides to pursue marketing and sales activities for the Product in countries or geographic regions outside of the Territory, Hospira shall provide Theravance with all reasonable additional technical/developmental and regulatory support, including, for example, regulatory support for Theravance’s supplemental regulatory filings, packaging and product development, labeling, and Regulatory Authority inspections. Any 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-approval inspections of the Facility that may be required by relevant Regulatory Authorities as a result shall be reimbursed in accordance with Section 7.3(c).
Changes in Project Scope. Changes in projects cope will be addressed as stated in Section 6.e(3).
Changes in Project Scope. For the purposes of this Agreement, an environmental assessment under Article 12 of the NLCA (i.e. Part 5 or Part 6), except for project amendments to Project Certificates or other licenses or permits, is deemed to be a Change in Scope.
Changes in Project Scope. If unanticipated changes occur in the product development project or Product Specifications, or if technical difficulties result in the requirement for Abbott to perform either additional or repeat work, Abboxx'x xxxts for such work shall be paid by Iomed, subject to Iomed's prior approval.
Changes in Project Scope. In the event of any changes to the Project scope that may alter the APE, USACE will consult with the SHPO and other Consulting Parties pursuant to 36 CFR § 800.2 through § 800.5.
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 wit...
Changes in Project Scope. A. When there is a project scope change, or a new project element is added to an undertaking after Section 106 review has concluded, or when a project undergoes an environmental re-evaluation, then WSDOT in consultation with the appropriate Lead Federal Agency, or WFLHD shall assess the need for additional consultation with SHPO and other consulting parties as follows.
B. Additional consultation will not be required under the following conditions:
1. The APE has not changed beyond the limits of previous identification efforts; and
2. There is no change to the effects finding; and
3. Less than 5 years have passed since historic properties have been documented within the APE; or
4. The project scope change is an undertaking listed in Appendix B and will require no further review.
5. There has been no change to ground surface visibility due to natural or manmade causes.
C. If the above conditions are not met, WSDOT or WFLHD, in consultation with the appropriate Lead Federal Agency, SHPO and other consulting parties, shall review the project in accordance with their respective responsibilities under Stipulation IV.D.
Changes in Project Scope. If a project undergoes a major change in scope or a change in scope resulting in a variance of more than 25% from: (1) the total project cost, (2) the number of acres benefits, (3) total AAHUs, or (4) the ratio of the total cost to the number of acres benefited or total project cost to total project AAHUs, then the project sponsors will submit a report to the TC explaining the reason(s) for the scope change, the impact on cost and benefits, and a statement from the local sponsor endorsing the change. The TC will review the report and recommend to the TF approval or rejection of the change. Changes in project scope resulting in an increase in total project cost are discussed in Section 5.d.
Changes in Project Scope. If changes occur in the Project or Bulk Drug Substance Specifications, or if technical difficulties require that Abbott perform either additional work or repeat work, and provided such work is unrelated to Xxxxxx’x fault or negligence, in advance of incorporating such changes or performing any work associated therewith, Abbott shall consult with Seattle Genetics and thereafter provide Seattle Genetics with a new or revised written test protocol with cost estimates for such work. If Seattle Genetics approves such fee and protocols, Abbott shall perform such work and Seattle Genetics shall pay Xxxxxx’x fee for such work in the manner and at the time as agreed upon by the Parties in conjunction with the approval of the work.
Changes in Project Scope. If changes occur in the Project or Bulk Drug Substance Specifications, or if technical difficulties require that Abbott perform either additional work or repeat work, and provided such work is unrelated to Xxxxxx’x fault or negligence, in advance of incorporating such changes or performing any work associated therewith, Abbott shall consult with ZymoGenetics and thereafter provide ZymoGenetics with a new or revised written test protocol with cost estimates for such work. If ZymoGenetics approves such costs and protocols, Abbott shall perform such work and ZymoGenetics shall pay Xxxxxx’x costs for such work in the manner and at the time as agreed upon by the Parties in conjunction with the approval of the work.
