ALLOCATION OF BURDEN OF PRODUCT RECALL Sample Clauses

ALLOCATION OF BURDEN OF PRODUCT RECALL. In the event (a) any government authority issues a request, directive or order that First Gen FDP and Second Gen FDP prepared from Fermentation Pellets, First Gen PDS and/or Second Gen PDS manufactured by CBSH for SERAGEN be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) SERAGEN shall reasonably determine that the Product should be recalled, the Parties shall take all appropriate actions to effectuate the recall as determined by SERAGEN and/or by the applicable Regulatory Agency, and shall cooperate in the investigations surrounding the recall. For clarity, as between the Parties, SERAGEN shall have responsibility for and exclusive control of all recall activities. In the event that such recall results from (i) the failure of CBSH personnel or subcontractors to follow cGMP, (ii) the failure of CBSH personnel or subcontractors to follow and execute the Production Record and required MRR documentation as written and approved by both Parties, (iii) the failure of the Facility equipment or utilities, (iv) the failure or non-conformance of the raw materials with SOPs or Specifications, (v) the breach of CBSH's obligations, representations or warranties hereunder or (vi) the acts or omissions of CBSH's subcontractors, CBSH shall (A) promptly replace such Fermentation Pellets, First Gen PDS and/or Second Gen PDS necessary for SERAGEN to replace the recalled Batches of First Gen FDP and Second Gen FDP, at no additional cost to SERAGEN, consistent with directions received from the appropriate Regulatory Agency and (B) promptly reimburse SERAGEN for its reasonable direct costs and third-party expenses documented and actually incurred in recalling the affected Product and replacing such Product at the wholesaler level. In all other cases, SERAGEN shall be responsible for the costs and expenses of recall, including the cost of replacement material for the Product. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Fermentation Pellets, First Gen PDS and/or Second Gen PDS and all other costs incurred in connection with such recall, but shall not include lost profits of either Party.

ALLOCATION OF BURDEN OF PRODUCT RECALL. In the event (a) any government authority issues a request, directive or order that FDP prepared from PRODUCT supplied by COPHARMA to SERAGEN be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) SERAGEN or COPHARMA shall reasonably determine that the PRODUCT should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. In the event that such recall results from any cause or event arising from the manufacture, storage or handling of the PRODUCT by COPHARMA in a manner which does not comply with the Manufacturing and Release Requirements (excluding defects relating to packaging or labeling supplied by or prepared at the direction of SERAGEN), COPHARMA shall be responsible for all expenses of the recall (except that COPHARMA and SERAGEN shall share such expenses equally if such recall is due to a failure by SERAGEN to meet the Manufacturing and Release Requirements during a Process Improvement requested by or approved by SERAGEN) and COPHARMA shall promptly replace such PRODUCT at no additional cost to SERAGEN consistent with directions received from the appropriate governmental authority. In all other cases, SERAGEN shall be responsible for the expenses of recall, including the cost of replacement material for the PRODUCT. For the purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled PRODUCT and all other costs incurred in connection with such recall, but shall not include lost profits of either party.