Samples; Acceptance. Lonza shall deliver to Trubion or its designee samples (including, as requested by Trubion, in-process samples) of all Batches manufactured under this Agreement, as and when Batches are manufactured and otherwise in accordance with the Quality Agreement and applicable written processes and procedures approved by both Parties, to enable Trubion or its designee to test the Bulk Drug as described in Section 11 of this Agreement and the Quality Agreement. Lonza shall also provide the related consolidated Batch Record and other Batch documentation described in the Quality Agreement for each Batch of Bulk Drug as soon as possible after each such Batch is manufactured. Upon receipt of samples of a particular Batch of Bulk Drug together with the related consolidated Batch Record and other Batch documentation, Trubion or its designee may inspect and perform testing on such samples and review the Batch Record and other batch documentation for each such Batch, in good faith and as soon as reasonably practicable, and, in the absence of an investigation of such Batch pursuant to the Quality Agreement or Section 8.1 hereof, such testing and review shall be completed within *** after Trubion's receipt of samples of such Batch together with the related consolidated Batch Record and other Batch documentation. Any investigation shall be initiated and conducted in accordance with Trubion's applicable standard operating procedure. Subject to Trubion's rights to make claims under Section 8 hereof, a Batch shall be deemed to have been accepted by Trubion on the date (the "Acceptance Date") on which the first of the following events occurs: (a) the receipt by Lonza of written notice from Trubion that such Batch has been released by Trubion pursuant to applicable release testing standard operating procedures or protocols, as described in the Quality Agreement, and (b) the failure of Trubion to issue a notice of investigation or rejection in accordance with Section 8 hereof and within *** after Trubion's receipt of samples of such Batch together with the related consolidated Batch Record and other Batch documentation.
Samples; Acceptance. Lonza shall deliver to Trubion or its designee samples (including, as requested by Trubion, in-process samples) of all Batches manufactured under this Agreement, as and when Batches are manufactured and otherwise in accordance with the Quality Agreement and applicable written processes and procedures approved by both Parties, to enable Trubion or its designee to test the Bulk Drug as described in Section 11 of this Agreement and the Quality Agreement. Lonza shall also provide the related consolidated Batch Record and other Batch documentation described in the Quality Agreement for each Batch of Bulk Drug as soon as possible after each such Batch is manufactured. Upon receipt of samples of a particular Batch of Bulk Drug together with the related consolidated Batch Record and other Batch documentation, Trubion or its designee may inspect and perform testing on such samples and review the Batch Record and other batch documentation for each such Batch, in good faith and as soon as reasonably practicable, and, in the absence of an investigation of such Batch pursuant to the Quality Agreement or Section 8.1 hereof, such testing and review shall be completed within *** after Trubion's receipt of samples of such Batch together with the related consolidated Batch Record and other Batch documentation. Any investigation shall be initiated and conducted in accordance with Trubion's applicable standard operating procedure.
