SENTI RESPONSIBILITIES Sample Clauses
SENTI RESPONSIBILITIES. 8.1. Except as otherwise provided in a Statement of Work, Senti will be responsible for:
8.1.1. Obtaining all Regulatory Approvals, without prejudice to Provider’s obligation to perform any Services for regulatory compliance assistance agreed in the applicable Statement of Work in accordance with such SoW and the Quality Agreement and;
8.1.2. Informing Provider in writing of any changes in the Territory that affect the Services as far in advance as reasonably practicable before such change is implemented. For clarity, no such change in the Territory shall require the approval of Provider except to the extent it would necessitate a change to the scope of Services under any applicable Statement of Work, in which case Senti shall notify Provider of the required changes to the SoW and such changes shall only be effected in accordance with the process set forth in Section 5.7 (Changes to Statements of Work);
8.1.3. Final release of each Batch and determining the suitability of each Batch for use, subject to Provider’s delivery of complete and accurate Batch Documentation and other documentation as required under the Quality Agreement with respect thereto;
8.1.4. Use of the Product by or on behalf of Senti or its Affiliates (other than by or on behalf of Provider) in accordance with all Laws in the Territory;
8.1.5. Creating and approving the content of any label that will be applied to Product by Provider in accordance with Laws and obtaining Regulatory Approval for such labels and content;
8.1.6. Establishing and providing Product specifications, storage conditions and shelf-life;
8.1.7. Complying with all Laws that relate to the handling, transport, distribution, sale and use of any Product or Senti Supplies by or on behalf of Senti or its Affiliates (other than by or on behalf of Provider).
SENTI RESPONSIBILITIES. 8.1. Except as otherwise provided in a Statement of Work, Senti will be responsible for:
8.1.1. Obtaining all Regulatory Approvals, without prejudice to Provider’s obligation to perform any Services for regulatory compliance assistance agreed in the applicable Statement of Work in accordance with such SoW and the Quality Agreement and;
8.1.2. Informing Provider in writing of any changes in the Territory that affect the Services as far in advance as reasonably practicable before such change is implemented. For clarity, no such change in the Territory shall require the approval of Provider except [***], in which case [***];
8.1.3. Final release of each Batch and determining the suitability of each Batch for use, subject to Provider’s delivery of complete and accurate Batch Documentation and other documentation as required under the Quality Agreement with respect thereto;
8.1.4. Use of the Product by or on behalf of Senti or its Affiliates (other than by or on behalf of Provider) in accordance with all Laws in the Territory;
8.1.5. Creating and approving the content of any label that will be applied to Product by Provider in accordance with Laws and obtaining Regulatory Approval for such labels and content;
8.1.6. Establishing and providing Product specifications, storage conditions and shelf-life;
8.1.7. Complying with all Laws that relate to the handling, transport, distribution, sale and use of any Product or Senti Supplies by or on behalf of Senti or its Affiliates (other than by or on behalf of Provider).