Review of Batch Documentation. Synthorx will notify Provider in writing of its acceptance or rejection of such Conforming Batch within […***…] of receipt of the complete Batch documentation relating to such Batch. During this review period, the parties agree to respond promptly, but in any event within […***…], to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch documentation.
Review of Batch Documentation. Radius shall review the Batch Documentation for each Batch, and may test, subject to the Quality Agreement, samples of the Batch against the Specifications. Radius shall notify Xxxxxx in writing of its Acceptance or rejection of such Batch within thirty (30) calendar days of receipt of the complete Batch Documentation relating to such Batch. During this review period, each Party agrees to respond without undue delay, but in any event within ten (10) calendar days, to any reasonable inquiry or request for a correction or change by the other Party with respect to such Batch Documentation. Radius has no obligation to Accept a Batch if such Batch was not Manufactured in accordance with the Standard; provided, however, that Xxxxxx and/or Xxxxxx Pharma shall be conclusively deemed [*] with respect to the relevant Manufacture if it can be shown, by way of the Batch Documentation, documents related to the Manufacture other than Batch documentation or samples of the Product, that the Product has been Manufactured in accordance with the Standard.
Review of Batch Documentation. 9 7.4 STORAGE AND PACKAGING FOR DISPATCH................................... 9 7.5 TRANSPORT............................................................ 9 7.6 SHIPMENT OF LDT FINISHED PRODUCTS UNDER QUARANTINE................... 9 8
Review of Batch Documentation. After detailed review of the batch documentation of each batch NOVARTIS associate is responsible that a statement of compliance with cGMP (CoC, confirmation statement) is included in the certificate of analysis (CoA) that is signed by a qualified person. A suitable format of this statement or document will be mutually agreed. IDENIX will review the complete manufacturing batch record of LdT Finished Products of the validation campaign and the first commercial batch produced for IDENIX. In case of critical deviations IDENIX may request a full copy of batch record in order accept the conclusions drawn by NOVARTIS.
Review of Batch Documentation. Each party will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Atara will notify Manufacturer in writing of its acceptance or rejection of such Batch based on [ * ] commencing upon Atara’s receipt of the Batch Documentation relating to such Batch. Each party will use commercially reasonable efforts to review the Batch Documentation within [ * ] following receipt. During this review [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. period, the parties agree to respond promptly, but in any event within [ * ], to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch Documentation.
Review of Batch Documentation. 7.1 After detailed review of the batch documentation of each batch by SANDOZ, SANDOZ shall ensure that a statement of compliance with cGMP (Certificate of Compliance (“CoC”), is included or attached to the certificate of analysis (“CoA”) that is signed by a qualified person.
7.2 The CoC shall include at a minimum the following: batch identification, name and address of SANDOZ, date of manufacturing/release/expiration, confirmation that the batch was manufactured/tested in compliance with cGMP requirements and per the registered manufacturing process, confirmation that the batch records for the batch have been reviewed and followed SANDOZ procedures and cGMP requirements and signature of certification.
Review of Batch Documentation. After detailed review of the Batch documentation of each Batch by SANDOZ, SANDOZ is responsible to ensure that a statement of compliance with GMP (Certificate of Conformity/Compliance, confirmation statement) signed by [***] is included or attached to the certificate of analysis (CoA) that is signed by the [***] and [***]. SANDOZ shall also provide the following Certificates and Manufacturing Records (also known as Batch Release Support Information), to Alder for each Batch, to enable Alder to perform Batch review and disposition. Refer to Attachment P for detailed content elements of the SANDOZ Batch Release Support Information. • Copies of SANDOZ-executed Batch records (to include [***], and as applicable, [***]) that have been reviewed by SANDOZ manufacturing and SANDOZ QA • SANDOZ-Certificate of Analysis • SANDOZ-Certificate of Conformity for each Batch. Alder will provide instructions on the required derivation and formatting for the Retest date. The Certificate of Compliance will contain a statement attesting that the Batch was prepared in conformance with cGMP; including reference to relevant governing regulation(s). • SANDOZ material report(s) summarizing starting materials and raw materials used (material number, batch number, material status, expiry date, quantity) [***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 21/73 CONFIDENTIAL • Copy of SANDOZ Batch disposition checklist • Copies of approved QC data records (in-process) including raw data (See Attachment Q) • Copies of approved QC data records (BDS) including raw data (See Attachment Q) • All deviations reports, including process and product related Deviations, Out of Specification (OOS) and Out of Expectation (OOE) reports associated with the Batch. Any additional requests under the terms stated below shall be approved by both parties.
Review of Batch Documentation. Each Party will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product per the applicable Work Order against the Specifications. Atara will notify Manufacturer in writing of its acceptance or rejection of such Batch based on not more than [ * ] review cycles completed within a period of [ * ] commencing upon Atara’s receipt of the Batch Documentation relating to such Batch. Each Party will use [ * ] to review the Batch Documentation within less than [ * ] review cycles and within less than [ * ] following receipt. During this [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. review period, the Parties agree to respond promptly, but in any event within [ * ], to any reasonable inquiry or request for a correction or change by the other Party with respect to such Batch Documentation.
Review of Batch Documentation. Atara will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Atara will notify Manufacturer in writing of its acceptance or rejection of such Batch within [ * ] of receipt of the complete Batch Documentation relating to such Batch. During this review period, the parties agree to respond promptly, but in any event within ten (10) days, to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch Documentation.
Review of Batch Documentation. Each party will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Atara will notify Manufacturer in writing of its acceptance or rejection of such Batch based on not more than [ * )] review cycles completed within a period of [ * ] commencing upon Atara’s receipt of the Batch Documentation relating to such Batch. Each party will use commercially reasonable efforts to review the Batch Documentation within less than [ * ] review cycles and within less than [ * ] following receipt. During this review period, the parties agree to respond promptly, but in any [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. event within [ * ], to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch Documentation.
