Common use of Recall of Product Clause in Contracts

Recall of Product. In the event PRAECIS shall be required to recall any Product Produced hereunder because such Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that PRAECIS elects to institute a voluntary recall, PRAECIS shall be responsible for coordinating such recall. PRAECIS promptly shall notify BAXTER if any Product Produced hereunder is the subject of a recall and provide BAXTER with a copy of all documents relating to such recall. BAXTER shall cooperate with PRAECIS in connection with any such recall. PRAECIS shall be responsible for all of the costs and expenses of any such recall unless such recall is caused *** APPROXIMATELY 3 LINES OMITTED *** , in which case BAXTER will bear all reasonable costs associated with such recall, product withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom PRAECIS deems appropriate); provided however that solely in respect of administrative and operating costs and expenses, XXXXXX'x liability for conducting the recall shall be in accordance with and up to a cumulative total maximum amount set forth in the chart below. Notwithstanding the foregoing, in no event shall XXXXXX'x liability for costs associated with such recall, product withdrawal or field correction exceed the Purchase Price for the Product which is the subject of such recall, product withdrawal or field correction. ADMINISTRATIVE NUMBER OF COST CAPS BY CONSIGNEES RECALL CLASS --------------------------------------- I II III ------------------------------------------------------- *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***

Appears in 1 contract

Samples: Commercial Supply Agreement (Praecis Pharmaceuticals Inc)

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Recall of Product. 16.1 In the event PRAECIS AMYLIN shall be required to recall any Product Produced hereunder because such Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that PRAECIS AMYLIN elects to institute a voluntary recall, PRAECIS AMYLIN shall be responsible for coordinating such recall. PRAECIS AMYLIN promptly shall notify BAXTER if any Product Produced hereunder is the subject of a recall and provide BAXTER with a copy of all documents relating to such recall. BAXTER shall cooperate with PRAECIS AMYLIN in connection with any such recall. PRAECIS Unless such recall is caused (a) solely by the negligence of BAXTER, (b) or to the extent such recall is due to the willful misconduct of BAXTER, or (c) such recall is caused solely by XXXXXX’x breach of this Agreement, AMYLIN shall be responsible for all of the costs and expenses of any such recall unless and shall reimburse BAXTER for its reasonable expenses (including labor) in connection with such cooperation. In the event a recall is necessary because both (i) BAXTER has delivered a non-conforming Product to AMYLIN, and (ii) such non-conformity is solely due to the negligence or to the extent such recall is caused *** APPROXIMATELY 3 LINES OMITTED *** due to the willful misconduct of XXXXXX, in which case BAXTER XXXXXX will bear all reasonable costs associated with such recall, product withdrawal or field correction recall (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom PRAECIS AMYLIN deems appropriate); provided however that solely in respect of administrative and operating costs and expenses, XXXXXX'x liability for conducting the recall shall be ) in accordance with and up to a cumulative total maximum amount set forth in the chart below. Notwithstanding ; notwithstanding the foregoingchart below, provided, however, in no event shall XXXXXX'x XXXXXX’x liability for costs associated with such recall, product withdrawal or field correction recall exceed [***] percent ([***]%) of the Purchase Price paid to BAXTER by AMYLIN for the Product which is the subject of such recall, product withdrawal or field correction. ADMINISTRATIVE NUMBER OF COST CAPS BY CONSIGNEES RECALL CLASS --------------------------------------- * Confidential Treatment Request(ed) Number of Consignees Recall Class (as classified by Regulatory Authority) I II III ------------------------------------------------------- *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** <[***] $ [***] $ [***] $ [***] [***] $ [***] $ [***] $ [***] [***] $ [***] $ [***] N/A [***] $ [***] $ [***] N/A >[***] $ [***] per consignee $ [***] per consignee N/A Article 17, INTELLECTUAL PROPERTY

Appears in 1 contract

Samples: Commercial Supply Agreement (Amylin Pharmaceuticals Inc)

Recall of Product. In 16.1 Each party promptly shall notify the event PRAECIS shall other if any Batch of Product is alleged or proven to be required to recall any Product Produced hereunder because such Product may violate local, state or federal laws or regulations, the laws or regulations subject of any applicable foreign government or agency or the Product Specifications, or in the event that PRAECIS elects to institute a voluntary recall, PRAECIS market withdrawal or correction. CLIENT shall be responsible for coordinating such any recall, market withdrawal or field correction of Product, and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. PRAECIS promptly CLIENT shall notify BAXTER if any Product Produced hereunder is the subject of a recall and provide BAXTER with a copy of all documents relating to such recall, market withdrawal or field correction. BAXTER shall cooperate with PRAECIS CLIENT (including providing CLIENT with all data, information and documents requested by CLIENT) in connection with any such recall, market withdrawal or field correction, at CLIENT's expense. PRAECIS Unless such recall is [CONFIDENTIAL TREATMENT REQUESTED] , CLIENT shall be responsible for all of the costs and expenses of any such recall unless recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because both (i) BAXTER has delivered a non-conforming Product to CLIENT, and (ii) such recall non-conformity is caused *** APPROXIMATELY 3 LINES OMITTED *** [CONFIDENTIAL TREATMENT REQUESTED], in which case BAXTER will bear all reasonable costs associated with such recall, product market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom PRAECIS CLIENT deems appropriate); provided however that solely in respect of administrative and operating costs and expenses, XXXXXX'x liability for conducting the recall shall be ) in accordance with and up to a cumulative total maximum amount set forth in the chart below. Notwithstanding : Recall Class Number of Consignees [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED] In the foregoing, in no event shall XXXXXX'x liability for costs associated with such a recall, product market withdrawal or field correction exceed the Purchase Price is necessary because both (i) BAXTER has delivered a non-conforming Product to CLIENT, and (ii) such non-conformity is due [CONFIDENTIAL TREATMENT REQUESTED], or [CONFIDENTIAL TREATMENT REQUESTED] XXXXXX'x breach of its warranties or obligations under this Agreement, BAXTER additionally will be responsible for the Product replacement cost of all returned Kits which is are the subject of such recall, product market withdrawal or field correction. ADMINISTRATIVE NUMBER OF COST CAPS BY CONSIGNEES RECALL CLASS --------------------------------------- I II III ------------------------------------------------------- *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***correction [CONFIDENTIAL TREATMENT REQUESTED].

Appears in 1 contract

Samples: Commercial Supply Agreement (Idec Pharmaceuticals Corp / De)

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Recall of Product. 16.1 In the event PRAECIS AMYLIN or Collaboration Partner shall be required to recall any Product Produced hereunder because such Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that PRAECIS AMYLIN or Collaboration Partner elects to institute a voluntary recall, PRAECIS AMYLIN or Collaboration Partner shall be responsible for coordinating such recall. PRAECIS AMYLIN or Collaboration Partner promptly shall notify BAXTER if any Product Produced hereunder is the subject of a recall and provide BAXTER with a copy of all documents relating to such recall. BAXTER shall cooperate with PRAECIS AMYLIN and/or Collaboration Partner in connection with any such recall. PRAECIS Unless such recall is caused (a) solely by the negligence of BAXTER, (b) or to the extent such recall is due to the willful misconduct of BAXTER, or (c) such recall is caused solely by XXXXXX’x breach of this Agreement, AMYLIN and/or Collaboration Partner shall be responsible for all of the costs and expenses of any such recall unless and shall reimburse BAXTER for its reasonable expenses (including labor) in connection with such cooperation. In the event a recall is necessary because both (i) BAXTER has delivered a non-conforming Product to AMYLIN, and (ii) such non-conformity is solely due to the negligence or to the extent such recall is caused *** APPROXIMATELY 3 LINES OMITTED *** due to the willful misconduct of XXXXXX, in which case BAXTER XXXXXX will bear all reasonable costs associated with such recall, product withdrawal or field correction recall (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom PRAECIS AMYLIN and/or Collaboration Partner deems appropriate); provided however that solely in respect of administrative and operating costs and expenses, XXXXXX'x liability for conducting the recall shall be ) in accordance with and up to a cumulative total maximum amount set forth in the chart below. Notwithstanding ; notwithstanding the foregoingchart below, provided, however, in no event shall XXXXXX'x XXXXXX’x liability for costs associated with such recall, product withdrawal or field correction recall exceed [***] percent ([***]%) of the Purchase Price paid to BAXTER by AMYLIN for the Product which is the subject of such recall, product withdrawal or field correction. ADMINISTRATIVE NUMBER OF COST CAPS BY CONSIGNEES RECALL CLASS --------------------------------------- * Confidential Treatment Request(ed) Price paid to BAXTER by AMYLIN for the Product which is the subject of such recall. Number of Recall Class (as classified by Regulatory Authority) Consignees I II III ------------------------------------------------------- *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** <[***] $[***] $[***] $[***] [***]-[***] $[***] $[***] $[***] [***]-[***] $[***] $[***] N/A [***]-[***] $[***] $[***] N/A >[***] $[***] per consignee $[***] per consignee N/A Article 17, INTELLECTUAL PROPERTY

Appears in 1 contract

Samples: Commercial Supply Agreement (Amylin Pharmaceuticals Inc)

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