Quality Control Sample. Novo Nordisk Delivery Technologies, Inc. shall provide Aradigm with the following: (a) a quality control sample of such Batch for the purpose of confirming that such Batch meets the Specifications; (b) a copy of the manufacturing Batch records and all relevant documentation for such Batch, together with written confirmation that such Batch records have been reviewed and approved by the quality assurance unit; and (c) and results of analysis performed by Novo Nordisk Delivery Technologies, Inc. in connection with its obligations under this Agreement. The quality control sample shall consist of Packaged Device and/or Packaged Dosage Form sampled so as to be representative of the Batch. No Batch of Packaged Dosage Forms or Packaged Devices shall be deemed to have been accepted until the quality control sample and associated documentation related to such Batch have been accepted by Aradigm pursuant to Section 5.4, such acceptance not to be unreasonably withheld or delayed.
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Sources: Restructuring Agreement (Aradigm Corp), Restructuring Agreement (Aradigm Corp)