Voluntary Recalls Sample Clauses

Voluntary Recalls. CEPH shall not initiate a voluntary recall until it has communicated with Advancis concerning the necessity for a recall and the scope of the recall. All coordination of any recall or field correction activities involving the Products shall be handled jointly by the parties, whether or not such action was initially requested by CEPH or Advancis.

Voluntary Recalls. Each Party will notify the other Party in the event that such Party determines that any Product already in interstate commerce in the Territory presents a risk of injury or gross deception or is otherwise defective and that recall of such Product is appropriate (a “Voluntary Recall”), and Purdue solely, after consultation with Distributor, will make the decision whether to initiate a Voluntary Recall and will control all recall activities and the Parties will follow the Product recall procedure set forth in the Quality Agreement. (a) If Distributor requests a Voluntary Recall, Distributor will be responsible for all expenses incurred by Purdue in connection with its cooperation in facilitating such Voluntary Recall, except to the extent that such Voluntary Recall is attributable to a breach by Purdue of its representations, warranties, covenants or agreements under this Agreement (in which case, to such extent, Purdue will be responsible for the expenses associated with any such Voluntary Recall, including any reasonable out of pocket expenses incurred by Distributor in connection with its cooperation in facilitating such Voluntary Recall). (b) If Purdue requests a Voluntary Recall, Purdue will be responsible for all expenses of such Voluntary Recall (including any reasonable out of pocket expenses incurred by Distributor in connection with its cooperation in facilitating such Voluntary Recall), except to the extent that such Voluntary Recall is attributable to a breach by Distributor of its representations, warranties, covenants or agreements under this Agreement (in which case, to such extent, Distributor will be responsible for the expenses associated with any such Voluntary Recall, including any reasonable out of pocket expenses incurred by Purdue in connection with its cooperation in facilitating such Voluntary Recall). (c) Any expenses incurred by either Party in connection with a Voluntary Recall will not be included in any calculation of Net Sales for any Product.

Voluntary Recalls. The Market Approval Holder and Bxxxxxx shall each, individually, have the right to determine whether a Voluntary Recall will be performed with respect to a Product and to perform the same (but in the event that each shall desire to undertake any given Voluntary Recall, MediGene (if the Market Approval Holder) shall have the first right to do so). In making the determination of whether a Voluntary Recall will be performed, each Party will (a) consider in good faith the deleterious effects of such Recall on the other Party and (b) engage in reasonable consultation with the other Party regarding the determination whether to effectuate such a Recall and the mechanics of effectuating the same.