Failed Batch. In accordance with the Quality Agreement, Hospira shall investigate, and cooperate fully with Theravance in investigating, any batch of the Product that fails to comply with cGMP or fails to meet the Product Specifications or any Regulatory Authority requirements. Hospira shall keep Theravance informed of the status of any investigation and, upon completion of the investigation, shall provide Theravance with a final written report describing the cause of the failure and summarizing the results of the investigation. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Failed Batch. In the event that any batch of the Product fails the testing requirements set forth in Section 5.11 as a result of non-compliance with cGMP, Applicable Law, or the Product Specifications, or otherwise fails to meet the Product Specifications, Hospira shall notify promptly Cempra in writing (and in any event within [*] Days of discovery of any such failure), investigate such failure, and cooperate fully with Cempra in attempting to determine the cause of the failure. Hospira shall (a) keep Cempra promptly informed in writing of the status of any such investigation, (b) [*], (c) promptly provide Cempra with copies of all batch records associated with such batch failure, to the extent reasonably requested by Cempra in writing, and (d) upon completion of the investigation, shall provide Cempra with a final written report describing the cause of the failure and summarizing the results of the investigation.
Failed Batch. Supplier shall investigate, and cooperate fully with Purchaser in investigating, any batch of Materials that fails to meet Materials Specifications or the requirements of any U.S. Governmental Authority with jurisdiction over the manufacture of Materials. Supplier shall keep Purchaser informed of the status of any investigation and, upon completion of the investigation, shall provide Purchaser with a final written report describing the cause of the failure and summarizing the results of the investigation.
Failed Batch. In accordance with the Quality & Technical Agreement and Section 5.8 hereof, Pfizer will investigate, and cooperate fully with Xxxxxxx in investigating, any batch of Product that fails to comply with the Manufacturing Process or Applicable Law (including, but not limited to, cGMP) or fails to meet the Product Specifications or any Regulatory Authority requirements. Pfizer will keep Xxxxxxx informed of the status of any investigation and, upon completion of the investigation, will provide Xxxxxxx with a final written report describing the cause of the failure and summarizing the results of the investigation. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Failed Batch. In accordance with the Quality Technical Agreement, Hospira shall investigate, and cooperate fully with Genzyme in investigating, any batch of Product that fails to comply with cGMP or fails to meet the Product Specifications or any Regulatory Authority requirements. Hospira shall keep Genzyme informed of the status of any investigation and, upon completion of the investigation, shall provide Genzyme with a final written report describing the cause of the failure and summarizing the results of the investigation, and the corrective and preventative actions, with a schedule for completion of each action.
Failed Batch. In accordance with the Quality Agreement, Hospira shall investigate, and cooperate fully with Durata in investigating, any Batch of the Product that fails to comply with cGMP or fails to meet the Specifications or any Regulatory Authority requirements. Hospira shall keep Durata informed of the status of any investigation and, upon completion of the investigation, shall provide Durata with a final written report describing the cause of the failure and summarizing the results of the investigation.
Failed Batch. In accordance with the Quality Agreement, Alvotech shall reasonably investigate, and cooperate with Alvogen in investigating, any batch of the Product that fails to comply with applicable cGMP or fails to meet the applicable Specifications, Regulatory Agency requirements or Applicable Law. Alvotech shall keep Alvogen informed of the status of such investigation and, upon completion thereof, shall provide Alvogen with a final written report describing the cause of such failure and summarizing the results of such investigation. Alvogen and Alvotech shall mutually agree upon whether any corrective and preventative actions (“CAPA”) are indicated as a result of the investigation, and, if Alvogen and Alvotech conclude that CAPAs are required, Alvogen and Alvotech shall agree upon the schedule of completion thereof, and Alvotech shall take all such CAPAs in accordance with such schedule of completion.
Failed Batch. In accordance with the Technical & Quality Agreement, Hospira shall investigate, and cooperate fully with Kythera in investigating, any batch of the Product that fails to comply with cGMP or fails to meet the Specifications or any Regulatory Authority requirements. Hospira shall keep Kythera informed of the status of any investigation and, upon completion of the investigation, shall provide Kythera with a final written report describing the cause of the failure and summarizing the results of the investigation.
Failed Batch. In accordance with the Quality & Technical Agreement, Pfizer will investigate, and cooperate fully with AMAG in investigating, any batch of Product that fails to comply with cGMP or fails to meet the Product Specifications or any Regulatory Authority requirements. Pfizer will keep AMAG informed of the status of any investigation and, upon completion of the investigation, will provide AMAG with a final written report describing the cause of the failure and summarizing the results of the investigation.
Failed Batch. In accordance with the Quality & Technical Agreement and Section 5.8 hereof, Pfizer will investigate, and cooperate fully with Xxxxxxx in investigating, any batch of Product that fails to comply with the Manufacturing Process or Applicable Law (including, but not limited to, cGMP) or fails to meet the Product Specifications or any Regulatory Authority requirements. Pfizer will keep Xxxxxxx informed of the status of any investigation and, upon completion of the investigation, will provide Xxxxxxx with a final written report describing the cause of the failure and summarizing the results of the investigation.
