Common use of Disposition and Batch Record Review Clause in Contracts

Disposition and Batch Record Review. Xxxxxxxxxx shall carry out Release or reject of each Batch of Drug Substance. On completion of Release of each Batch, and no later than [*****] Business Days following the performance of the final filtration and filling step of Drug Substance, Xxxxxxxxxx shall provide the Batch Record for such Batch to Dyax for review. Within [*****] Business Days following delivery of the complete Batch Record to Dyax, Dyax shall confirm in writing Dyax accepts Xxxxxxxxxx'x findings detailed in the Batch Record, or shall submit a complaint in accordance with the Quality Agreement in the form annexed thereto. Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Dyax of its acceptance of Xxxxxxxxxx'x findings in the Batch Record or in the absence of notice of rejection of such findings or the Batch within [*****] Business Days from such delivery of the Batch Record. Should an error or omission have occurred, Xxxxxxxxxx shall have [*****] Business Days to correct same, after which the [*****] Business Day period for Dyax to review shall restart. For Drug Product release testing, the CoA will be provided no later than [*****] Business Days following recipient of the Drug Product vials.

Disposition and Batch Record Review. Xxxxxxxxxx shall carry out Release or reject of each Batch of Drug SubstanceSubstance and Drug Product. On completion of Release of each Batch, and no later than [*****] Business Days following the performance of the final filtration and filling step of Drug Substancestep, Xxxxxxxxxx shall provide the Batch Record for such Batch to Dyax for review. Within [*****] Business Days following delivery of the complete Batch Record to Dyax, Dyax shall confirm in writing Dyax accepts Xxxxxxxxxx'x findings detailed in the Batch Record, or shall submit a complaint in accordance with the Quality Agreement in the form annexed thereto. Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Dyax of its acceptance of Xxxxxxxxxx'x findings in the Batch Record or in the absence of notice of rejection of such findings or the Batch within [*****] Business Days from such delivery of the Batch Record. Should an error or omission have occurred, Xxxxxxxxxx shall have [*****] Business Days to correct same, after which the [*****] Business Day period for Dyax to review shall restart. For Drug Product release testing, the CoA will be provided no later than [*****] Business Days following recipient of the Drug Product vials.

Disposition and Batch Record Review. Xxxxxxxxxx shall carry out Release or reject of each Batch of Drug SubstanceSubstance and Drug Product. On completion of Release of each Batch, and no later than [*****] Business Days following the performance of the final filtration and filling step of Drug Substancestep, Xxxxxxxxxx shall provide the Batch Record for such Batch to Dyax for review. Within [*****] Business Days following delivery of the complete Batch Record to Dyax, Dyax shall confirm in writing Dyax accepts Xxxxxxxxxx'x findings detailed in the Batch Record, or shall submit a complaint in accordance with the Quality Agreement in the form annexed thereto. Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Dyax Xxxx of its acceptance of Xxxxxxxxxx'x findings in the Batch Record or in the absence of notice of rejection of such findings or the Batch within [*****] Business Days from such delivery of the Batch Record. Should 12 / 12 Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. an error or omission have occurred, Xxxxxxxxxx shall have [*****] Business Days to correct same, after which the [*****] Business Day period for Dyax to review shall restart. For Drug Product release testing, the CoA will be provided no later than [*****] Business Days following recipient of the Drug Product vials.