Batch Sample definition

Batch Sample shall have the meaning set forth in Section 5.1.

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Batch Sample means the collec­istrator documentation of the conditions normally performed by the manufac­

Examples of Batch Sample in a sentence

• Such written notice shall specify the manner in which the Clinical Batch Sample fails to conform to the warranties set forth in Section 14.2.1. If Client does not submit written notice of rejection within such forty-five (45) day period such Clinical Batch will be deemed to be a Conforming Drug Substance and accepted by Client.

• Celladon will provide the analytical test results of its testing of the Batch Sample to Novasep for inclusion in the Batch Documentation.

• Celladon shall notify Novasep in writing of Celladon’s determination as to the conformity or non-conformity of the Batch to the Product Warranty, in each case by the later of (i) […***…] days after receipt of the Batch Sample at Celladon’s designated testing site and (ii) […***…] days after Celladon’s or its designee’s receipt of the Batch Documentation, or such other period as may be specified in the Quality Agreement (as applicable, the “Acceptance Period”).

• If the results of such analytical testing demonstrate that the Batch Sample fails to conform to Specifications, or it is determined that manufacturing of Product failed to meet the Product Warranty, Celladon shall notify Novasep in writing thereof before expiration of the applicable Acceptance Period (as extended, if applicable), after which time, if Celladon has not delivered written notice of rejection, such Batch shall be deemed accepted by Celladon.

• LONZA shall complete Quality Assurance Release and shall deliver to Client the necessary Batch Disposition Documentation and Clinical Batch Sample.

• If within the forty-five (45) day period Client’s quality assurance department makes a determination that Client believes such Clinical Batch Sample to be nonconforming, Client shall have the right to reject such Clinical Batch in its entirety and shall notify LONZA in writing within such forty-five (45) day period.

• If CSL finds the Batch Sample does not comply with clause 6.1 then CSL will if practicable replace the Notified Product in due time and after discussion with ▇▇▇▇▇.