Licensed Product Recall Sample Clauses
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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 mat...
Licensed Product Recall. 13.4.1 Subject to the Quality Agreement and the Transition Services Agreement, during the SOTC Period, AstraZeneca shall have decision-making authority over recalls and withdrawals, and after the SOTC Period during the Term, Buyer shall have decision-making authority over recalls and withdrawals.
13.4.2 The procedures governing the recall or market withdrawal of any Licensed Product supplied to Buyer under this Supply Agreement will be set out in the Quality Agreement.
13.4.3 Section 7.4 to the License Agreement is hereby incorporated herein; provided, however, that Buyer shall not be responsible for costs of a recall or market withdrawal of Licensed Products to the extent arising from a breach by AstraZeneca of this Supply Agreement or the Quality Agreement by, or fraud, willful misconduct or negligence on the part of, AstraZeneca or any of its Affiliates or any of their respective Personnel, or otherwise. The foregoing shall be without prejudice to any other rights or remedies that Buyer may have, whether under this Supply Agreement or otherwise.
Licensed Product Recall. PharmaEngine may at its discretion and will if requested to do so by Xenova, recall any Licensed Product in the Territory. The costs and expenses incurred by PharmaEngine and/or Sub-Licensees in connection with such recall shall be borne by PharmaEngine, unless such recall is both:
7.6.1 requested by Xenova or the Regulatory Authorities in the Territory; and
7.6.2 does not arise from any material breach of this Agreement by PharmaEngine or any material breach of the Sub-licence by the Sub-Licensee, or any negligence or intentional misconduct on the part of PharmaEngine or its Sub-licensee; in which cases Xenova shall reimburse to PharmaEngine all of such costs and expenses.
Licensed Product Recall