After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Creation Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Creation Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Creation Order within 15 minutes after the Creation Order has been called into the Transfer Agent.

Quality Control and Quality Assurance. CCX will perform or have its agents perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to VF will be the responsibility of CCX’s quality assurance group. CCX will perform its Batch review and release responsibilities in accordance with CCX’s and or its CMO’s standard operating procedures, cGMP and the Specifications. Each time CCX ships Bulk Drug Products to VF, it will give VF for each Batch of Bulk Drug Products a certificate of analysis and certificate of compliance (see Batch certificate requirements pursuant to European guideline EMA/INS/MRA/387218) including ​ Bulk Drug Product samples and a statement that the Batch has been manufactured and tested in accordance with Specifications and cGMPs. In the case of major deviations, critical deviations or out-of-Specification (“OOS”) investigations, a copy of the respective reports will be supplied to VF. Copies (e.g. as pdf) of Batch documents are sent to VF upon request or in accordance with the Quality Agreement. VF will have the sole responsibility for the release of Products to the market in the Territory. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of CCX or its CMO. VF, as applicable will be permitted to review and comment on the form and style of all Batch documents prior to initiation of Manufacturing Services and will have the right to use the Batch documents as required for any Regulatory filing ascribed to it in the License Agreement or otherwise to meet VF’s obligations under Applicable Law. Specific Bulk Drug Product related information contained in the Batch documents is CCX’s property.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Creation Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Creation Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Creation Order within 15 minutes after the Creation Order has been called into the Transfer Agent.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Redemption Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Redemption Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Redemption Order within 15 minutes after the Redemption Order has been called into the Transfer Agent.

Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement and otherwise as required to comply with cGMP. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Each time Patheon ships Products to Client, it will give Client a Certificate of Analysis and Certificate of Compliance, BSE/BTE and melamine statement, and a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is the exclusive property of Client.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Redemption Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Redemption Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Redemption Order within 15 minutes after the Redemption Order has been called into the Transfer Agent.

Quality Control and Quality Assurance. [[Organization A:Organization]] will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of [[Organization A:Organization]]’s quality assurance group. [[Organization A:Organization]] will perform its Batch review and release responsibilities in accordance with [[Organization A:Organization]]’s standard operating procedures, cGMP and according to the Specifications. Each time [[Organization A:Organization]] ships Products to Client, it will give Client for each Batch of Products a certificate of analysis and certificate of compliance (see Batch certificate requirements pursuant to European guideline EMA/INS/MRA/387218) including up to ​ Product samples and a statement that the Batch has been manufactured and tested in accordance with Specifications and cGMPs. In the case of major deviations, critical deviations or out-of-Specification (“OOS”) investigations, a copy of the respective reports will be supplied Copies (e.g. as pdf) of Batch documents are sent to Client upon request or in accordance with the Quality Agreement. Client will have the sole responsibility for the release of Products to the market. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of [[Organization A:Organization]]. Client will be permitted to review and comment on the form and style of all Batch documents prior to initiation of Manufacturing Services and will have the right to use the Batch documents as required for any Regulatory Approval or otherwise to meet Client obligations under Applicable Law. Specific Product related information contained in the Batch documents is Client property.

Quality Control and Quality Assurance. [[Organization A:Organization]] will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of [[Organization A:Organization]]'s quality assurance group. [[Organization A:Organization]] will perform its batch review and release responsibilities in accordance with [[Organization A:Organization]]'s standard operating procedures. Each time [[Organization A:Organization]] ships Products to Client, it will give Client a certificate of analysis and certificate of compliance, including deviations as specified by the Quality Agreement, including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of [[Organization A:Organization]]. Specific Product related information contained in those batch documents is Client property.

Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is Client property.

Quality Control and Quality Assurance. The Parties shall cooperate with each other in good faith to enter into the Quality Agreement as soon as practicable after the Closing, but in no event later than April 1, 2021. The Quality Agreement shall set forth the quality responsibilities of each Party in respect of the arrangements contemplated hereby. Following the execution of the Quality Agreement, each Party shall comply with its terms.