Reproduction, Rework or Reprocessing. If, during the Production of any Batch of Product, any reprocessing, rework, reproduction, or change is required in order to meet the Product Specifications, or if Celator requests any change with respect to any matter set forth in the Product Master Plan, Baxter shall conduct such reprocessing, rework, or reproduction and implement such change in compliance with cGMP’s. Any reprocessing, rework, reproduction or change, concerning compounding, aseptic filling, or capping must be approved in writing by Celator prior to implementation unless immediate action is required. Celator shall promptly reimburse Baxter for all costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change, except that in the event that any such reprocessing, rework, reproduction, or change results solely from Xxxxxx’x failure to Produce Products according to Product Requirements or Xxxxxx’x negligence or willful misconduct, Baxter shall be responsible for, and promptly reimburse Celator for, **************** in connection with such reprocessing, rework, reproduction, or change.
Reproduction, Rework or Reprocessing. If during the Production of any Batch of Drug Product, any reproduction or reprocessing is required in order for the Batch to meet the Specifications for Drug Product, BPS shall conduct, at its sole cost and expense and subject to Section 6.2, such reproduction or reprocessing in compliance with Applicable Laws, cGMPs and the BLA. Any reproduction or reprocessing which is not covered by Applicable Laws, cGMPs or the BLA must be approved in writing by NUVELO prior to implementation. BPS shall not perform any rework of any kind whatsoever on any Batch without the prior written or prior Electronically-documented consent of an authorized representative of NUVELO. Unless reproduction, NUVELO-approved rework, or reprocessing, is required as a result of a Non-conformity, such reproduction, [ * ] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. rework or reprocessing shall be set forth in an amendment to the applicable Plan and NUVELO shall be responsible for, and promptly reimburse BPS for the costs and expenses incurred for performance of such reproduction, NUVELO-approved rework, or reprocessing as such costs and expenses are set forth in the amendment to the applicable Plan. Reinspection, relabeling, or repackaging shall not be considered reproduction, rework, or reprocessing.
Reproduction, Rework or Reprocessing. If during the Production of any Batch of Product, any reprocessing, rework, or reproduction is required in order to meet the Product Specifications, BAXTER shall conduct such reprocessing, rework, or reproduction in compliance with the terms of the Quality Agreement, cGMPs, and the NDA. Any reprocessing, rework or reproduction, and the related costs and expenses, must be approved in writing by AMYLIN prior to implementation, such approval not to be unreasonably withheld and/or delayed. Re-packaging and re-inspection are not considered reproduction, rework or reprocessing. Unless such reprocessing, rework, or reproduction is required as a result of the negligence or willful misconduct of BAXTER, AMYLIN shall be responsible for, and promptly reimburse BAXTER for, all costs and expenses incurred in connection with such reprocessing, rework, or reproduction.
Reproduction, Rework or Reprocessing. If any reprocessing, rework, or reproduction is required in order to meet the Kit Component Specifications and/or Kit Specifications, BAXTER shall conduct such reprocessing, rework, or reproduction in compliance with cGMPs and the BLA. Any reprocessing, rework, reproduction, or change which is not covered by the BLA must be approved in writing by CLIENT prior to implementation. All costs of any such reprocessing, rework, reproduction, or change shall be allocated in accordance with Sections 7.2, 13.3 and 13.4.
Reproduction, Rework or Reprocessing. If during the Production of any Batch of Product, any reprocessing, rework, or reproduction is required in order to meet the Product Specifications, Catalent shall, at Catalent’s sole expense, conduct such reprocessing, rework, or reproduction in accordance with CGMPs and the BLA or MAA. Any reprocessing, rework, reproduction, or change which is not covered by CGMPs and the BLA or MAA must be approved in writing by Client prior to implementation. To the extent such reprocessing, rework, reproduction, or change is required as a result of the acts or omissions of Client, Client shall be responsible for, and promptly reimburse Catalent for all reasonable, documented costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change.
Reproduction, Rework or Reprocessing. If during the Production of any Batch of Product, any reprocessing, rework, or reproduction is required in order to meet the Product Specifications, BAXTER shall conduct such reprocessing, rework, or reproduction in compliance with cGMP’s. Any reprocessing, rework, reproduction, concerning compounding, aseptic filling, or capping must be approved in writing by PONIARD prior to implementation. If such reprocessing, rework, or reproduction is requested by PONIARD and not due to the failure of BAXTER to Produce according to Product Requirements, PONIARD shall be responsible for, and promptly reimburse BAXTER for all costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change.
Reproduction, Rework or Reprocessing. If during the manufacture of any Lot, any reprocessing, rework, or reproduction is required in order to meet the Specifications, XXXX shall conduct such reprocessing, rework, or reproduction in compliance with cGMPs. Any reprocessing, rework or reproduction which is not covered by cGMPs must be approved in writing by PURCHASER prior to implementation. Unless such reprocessing, rework or reproduction is required solely as a result of changes required to be made to the Specifications as agreed to by the parties, or the negligence or willful misconduct of PURCHASER, XXXX shall be responsible for all costs and expenses incurred in connection with such reprocessing, rework or reproduction.
Reproduction, Rework or Reprocessing. If, during the Production of any Batch of Product, any reprocessing, rework, or reproduction is required in order to meet the Product Specifications, upon Client’s prior, written approval, Catalent shall conduct such reprocessing, rework, or reproduction in compliance with CGMPs and the BLA or NDA (as applicable). Catalent will notify Client if any reprocessing, rework, reproduction, or change is not covered by CGMPs, the NDA, or BLA. Approved reprocessing, rework, or reproduction shall be billed separately to Client at mutually agreed upon, commercially reasonable fees.
