Manufacturing Failure definition

Manufacturing Failure means (i) Emergent’s failure to Deliver at least fifty percent (50%) of the aggregate quantity of all Vials of Product with respect to all Binding Purchase Orders (exclusive of those Vials used as retain samples, those Vials used for the stability program as set forth in the Quality Agreement and those Vials Manufactured but not Delivered by agreement of the Parties) within a rolling twelve (12) month period in accordance with this Agreement (other than where such failure is due to a Force Majeure), provided that (a) Aptevo may only make the determination as to whether such failure has occurred during the prior twelve (12) months as of the end of a calendar quarter (i.e., as of March 31, June 30, September 30, or December 31, as applicable) and (b) Aptevo must provide Emergent notice in writing within fifteen (15) days of such determination; or (ii) a termination of this Agreement by Emergent pursuant to Section 9.2.5.
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Manufacturing Failure means (i) Emergent’s failure to Deliver at least [****] of the aggregate quantity of all Vials of Product with respect to all Binding Purchase Orders (exclusive of those Vials used as retain samples, those Vials used for the stability program as set forth in the Quality Agreement and those Vials Manufactured but not Delivered by agreement of the Parties) within a rolling [****] period in accordance with this Agreement (other than where such failure is due to a Force Majeure), provided that (a) Aptevo may only make the determination as to whether such failure has occurred during the prior twelve [****] as of the [****] (i.e., as of [****], as applicable) and (b) Aptevo must provide Emergent notice in writing within [****] of such determination; or (ii) a termination of this Agreement by Emergent pursuant to Section 9.2.5.
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Manufacturing Failure is defined in Section 5.12(e)(i).
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Examples of Manufacturing Failure in a sentence

  • Notwithstanding the foregoing, PII shall not be considered in material default under this Agreement if such material default results from a Licensed Product Manufacturing Failure.

  • Should BI be found responsible for claims, losses or expenses caused by a Manufacturing Failure and not attributable to other causes for which BI is responsible, BI shall be entitled to indemnity from Transcend to the same extent as Transcend would be so entitled from BI under Section 11.1 above.

  • Transcend, its Affiliates and their respective employees and agents shall not be entitled to the indemnities set forth in this Section 11.1 where the loss, damage or expense for which indemnification is sought was caused by a failure by Transcend to manufacture (or have manufactured) a Licensed Product in compliance with agreed-upon product specifications set forth in the Supply Agreement (a "Manufacturing Failure").

  • Collingwood may terminate this Agreement immediately, without penalty or further obligation to Ovamed, if Ovamed fails to achieve remediation within such [*******] period and Collingwood shall immediately be entitled to the Manufacturing Failure License.

  • If the Recall is contributed to by both CMC’s Manufacturing Failure and Customer Failure then CMC shall be liable for a proportion of the reasonable Commercial Supply Agreement – JUNE 2011 56 documented expenses actually and reasonably incurred by Customer in undertaking the Recall of those specific Products to the extent caused by CMC’s Manufacturing Failure subject to the provisions of Clause 12.10.

  • Collingwood may terminate this Agreement immediately, without penalty or further obligation to Ovamed, if Ovamed fails to achieve remediation within such [*******] month period and Collingwood shall immediately be entitled to the Manufacturing Failure License.