Review of Batch Documentation; Acceptance. Rhythm will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Rhythm will notify Manufacturer in writing of its acceptance or rejection of such Batch within six (6) weeks 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. Rhythm has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process.
Review of Batch Documentation; Acceptance. Rhythm will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Rhythm will notify Manufacturer in writing of its acceptance or rejection of such Batch within six (6) weeks of receipt of the complete Batch Documentation relating to such Batch. During this review period, the parties agree to respond promptly to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch Documentation. Rhythm has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process. Within eight (8) working days following Rhythm’s delivery of written notice of acceptance of a Batch, Rhythm shall provide to Manufacturer the information required by Section 7(a) and (b) and arrange for collection of the Batch by it or its designee.
Review of Batch Documentation; Acceptance. Customer will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Customer will notify Manufacturer in writing of its acceptance or rejection of such Batch within thirty (30) business days 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 by the other party with respect to such Batch Documentation. Customer has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process.
Review of Batch Documentation; Acceptance. Anterios will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Anterios 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 [*] , to any reasonable inquiry or request for a correction or change by the other party with respect to such Batch Documentation. Anterios has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) or the Manufacturing Process.
Review of Batch Documentation; Acceptance. COMPANY will review the Batch Documentation for each Batch of Product after delivery of the Batch Documentation and may test samples of the Batch of Product against the Specifications [***]. COMPANY will notify FRESENIUS in writing of its acceptance or rejection of such Batch within [***] of date of receipt (as set forth in Section 16.2) of the electronic copy of the complete Batch Documentation relating to such Batch, subject to Section 16.6. During this review period, the Parties agree to respond promptly, to any reasonable inquiry or request for a correction or change by the other Party with respect to such Batch Documentation. COMPANY has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with GMP and/or the Manufacturing Process specified in the MBR for the Batch; [***]. If such notice is not given by COMPANY in the time period specified above, the Product is deemed to be delivered in the right quantities, in compliance with the Specifications, and Manufactured in accordance with GMP and the agreed Manufacturing Process subject to Section 16.6.
Review of Batch Documentation; Acceptance. RADIUS will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. For the avoidance of doubt, RADIUS herewith takes note that certain parts of the Batch Documentation will be written in French as the Facility is in Belgium. RADIUS shall pay all costs incurred with any translation of such Records requested by RADIUS. RADIUS will notify Manufacturer in writing of its acceptance or rejection of such Batch within [*] ([*]) weeks 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 [*] ([*]) days, to any reasonable inquiry by the other party with respect to such Batch Documentation. RADIUS has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.
Review of Batch Documentation; Acceptance. RADIUS will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. For the avoidance of doubt, RADIUS herewith takes note that certain parts of the Batch Documentation will be written in French as the Facility is in Belgium. RADIUS shall pay all costs incurred with any translation of such Records requested by RADIUS. RADIUS will notify Manufacturer in writing of its acceptance or rejection of such Batch within six (6) weeks 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 by the other party with respect to such Batch Documentation. RADIUS has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process.
Review of Batch Documentation; Acceptance. Tectonic will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Tectonic 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 the (“Review Period”). If Manufacturer does not receive written notice of Tectonic’s acceptance or rejection of a Batch of Product within the first [***] period within such Review Period, Manufacturer will provide written notice to Tectonic. If Manufacturer does not receive notice of rejection from Tectonic within the Review Period, then such Batch of Product will be deemed accepted by Tectonic. 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. Tectonic has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable), all other Applicable Law, and the Manufacturing Process (a “Non-Conforming Batch”).
Review of Batch Documentation; Acceptance. COMPANY will review the Certificate of Analysis (CoA) for each Batch of Product and may, but is not obligated to, test samples of the Batch of Product against the Specifications. COMPANY will notify AmbioPharm in writing of its acceptance or rejection of such Batch within four (4) weeks of receipt of the complete Certificate of Analysis (CoA) 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 documentation. COMPANY has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process.
Review of Batch Documentation; Acceptance. Manufacturer will provide all Batch Documentation to Alnylam prior to the shipment of any such Products to Alnylam. Following the receipt of a complete and accurate copy of the executed Batch Documentation, Alnylam will use commercially reasonable efforts to review such Batch Documentation and advise Manufacturer of any deficiencies or corrections needed within [***] days (“Target Review Period”) of receiving such Batch Documentation. Following Manufacturer’s resolution (to Alnylam’s satisfaction) of any issues raised by Alnylam’s review of the relevant Batch Documentation, Manufacturer shall ship the Batch of Product without delay. If Alnylam is to exceed the Target Review Period, Alnylam will notify Manufacturer of the exception to the Target Review Period at least [***] days prior to the expiration of the Target Review Period and advise Manufacturer of a third party GMP storage facility of Alnylam’s choosing to ship the Product. [***] Alnylam’s acceptance of the Product will occur at the time of delivery of the Product to the carrier pursuant to Section 7. Alnylam’s acceptance of the Product shall not affect the Product warranties provided by Manufacturer pursuant to this Agreement. Notwithstanding Alnylam’s prior acceptance, should any Batch of Product fail to conform to the warranty set forth in Section 11.1(e), Alnylam shall have the remedies set forth in Section 6.5, provided that such nonconformity is not the direct result of [***]
