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. 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. 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.
Review of Batch Documentation; Acceptance. MyoKardia will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. MyoKardia will notify Sanofi or one of its Affiliates 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. MyoKardia 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, the Specifications, the Technical Protocol, the Quality Agreement, and all other Applicable Law (“Non-Conforming Product”).
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. Graphite will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Graphite will notify WuXi ATU in writing of its acceptance or rejection of such Batch in accordance with the procedure and timelines set forth in the Quality Agreement. In the absence of such written notice, the Batch shall be deemed to have been accepted by Graphite. [***].
Review of Batch Documentation; Acceptance. Portola will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. Portola will notify Manufacturer in writing of its acceptance or rejection of such Batch within four (4) weeks of receipt of the Batch Documentation relating to such Batch; provided, that, if Portola does not provide Manufacturer with notice of rejection of a Batch on or before the expiration of such review period, Portola shall be deemed to have accepted 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. Delays by Portola in reviewing of batch documentation do not extend the obligation of payment period for the related invoices. Subject to Section 6.4, Portola has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with the Quality Agreement and the Manufacturing Process.
