Common use of Changes to Specifications and Process Clause in Contracts

Changes to Specifications and Process. The Specifications shall be amended only as agreed upon in writing by Company and SAFC; provided, however, that the Parties agree to cooperate to amend or supplement the Specifications to the extent reasonably necessary to comply with changes in applicable laws or regulations or the requirements of applicable Regulatory Agencies or as Company may reasonably request from time to time (provided such request is made in good faith). SAFC shall follow the change control procedures set forth in the Quality Agreement for any proposed changes in the Manufacturing Process. SAFC acknowledges that any such change(s) shall, in each case, comply with cGMP, this Agreement, all regulatory submissions, and the Quality Agreement. In the event such amendment (whether as a result of changes in applicable laws or regulations or the requirements of applicable Regulatory Agencies or at Company’s reasonable and good faith request or otherwise) requires additional cost or schedule adjustments for the Manufacture of Vector Product hereunder, Company and SAFC shall agree in good faith on an equitable adjustment to price or schedule or both, as appropriate. Any such amended Specifications shall be reflected in and attached hereto as an amended and restated Exhibit 2.

Changes to Specifications and Process. The Specifications shall be amended only as agreed upon in writing by Company and SAFC; provided, however, that the Parties agree to cooperate to amend or supplement the Specifications to the extent reasonably necessary to comply with changes in applicable laws or Applicable Laws and/or regulations or the requirements of applicable Regulatory Agencies or as Company may reasonably request from time to time (provided such request is made in good faith). SAFC shall follow the change control procedures set forth in the Quality Agreement for any proposed changes in the Manufacturing Processprocess. SAFC acknowledges that any such change(s) shall, in each case, comply with cGMPcGMP (if required), this Agreement, all regulatory submissions, Agreement and the Quality Agreement. In the event such amendment (whether as a result of changes in applicable laws or regulations Applicable Laws or the requirements of applicable Regulatory Agencies or at Company’s reasonable and good faith request or otherwise) requires additional cost or schedule adjustments for the Manufacture of Vector Product the Excipient or Raw Materials hereunder, Company and SAFC shall agree in good faith on an equitable adjustment to price or schedule or bothand/or schedule, as appropriate. Any such amended Specifications shall be reflected in and attached hereto as an amended and restated Exhibit Appendix 2.

Changes to Specifications and Process. The Specifications shall be amended only as agreed upon in writing by Company and SAFC***; provided, however, that the Parties agree to cooperate to amend or supplement the Specifications to the extent reasonably necessary to comply with changes in applicable laws or Applicable Laws and/or regulations or the requirements of applicable Regulatory Agencies or as Company may reasonably request from time to time (provided such request is made in good faith). SAFC *** shall follow the change control procedures set forth in the Quality Agreement for any proposed changes in the Manufacturing Processprocess. SAFC *** acknowledges that any such change(s) shall, in each case, comply with cGMPcGMP (if required), this Agreement, all regulatory submissions, Agreement and the Quality Agreement. In the event such amendment (whether as a result of changes in applicable laws or regulations Applicable Laws or the requirements of applicable Regulatory Agencies or at Company’s reasonable and good faith request or otherwise) requires additional cost or schedule adjustments for the Manufacture of Vector Product the Excipient or Raw Materials hereunder, Company and SAFC *** shall agree in good faith on an equitable adjustment to price or schedule or bothand/or schedule, as appropriate. Any such amended Specifications shall be reflected in and attached hereto as an amended and restated Exhibit Appendix 2.