Licensed Product Recall. If either Distributor or MPL obtains information that any of the Licensed Products or any portion thereof is alleged or proven not to conform with the labeling or the Licensed Product Registration for such Licensed Products in the Territory, it shall notify the other Party immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. MPL and Distributor shall each maintain such traceability records as are sufficient and as may be necessary to permit a recall or field correction of any Licensed Products. In the event (a) any applicable federal or state regulatory authority in the Territory should issue a request, directive or order that any of the Licensed Products be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) MPL or Distributor determines that any of the Licensed Products already in interstate commerce in the Territory present a risk of injury or gross deception or is otherwise defective, misbranded and/or adulterated and that recall of such Licensed Products is appropriate (any such event described in (a), (b) or (c), a "Recall"), each Party shall give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours after becoming aware of an event described in (a) or (b), or after making the determination described in (c). MPL shall have sole responsibility for determining all corrective action to be taken and to implement the Recall, but shall confer with Distributor and keep Distributor informed on a regular basis of MPL's progress in planning and implementing the Recall. Distributor will use Commercially Reasonable Efforts to cooperate with and assist MPL in connection therewith as may be requested by MPL. MPL shall be responsible for all expenses of effecting any such Recall (including any out-of-pocket expenses incurred by Distributor in connection with such cooperation), except to the extent such Recall is attributable to any negligence on the part of Distributor or any material breach by Distributor of its obligations under this Agreement, in which event Distributor will reimburse MPL for its reasonable costs and expenses incurred that are so attributable to such negligence or material breach by Distributor. MPL shall provide to Distributor replacement Licensed Products for any recalled Licensed Products at MPL's sole expense, except to the extent that such Recall is attributable to any negligence on the part of Distributor or any material breach by Distributor of its obligations under this Agreement or any other agreement then in force and effect between Distributor and MPL. Distributor's Annual Minimum Purchase Requirement pursuant to Section 5.02 or 7.01 shall be reduced by the value (based on the Net Wholesale Price) of the lots affected by such Recall.
Appears in 2 contracts
Sources: Distribution Agreement (Molecular Pharmacology (USA) LTD), Distribution Agreement (Molecular Pharmacology (USA) LTD)