Certain Product Events. (a) The Parties shall establish a joint product incident review team to consider any proposed Remedial Action with respect to Product in the Licensed Territory. If either Party is aware of a defect, incident or other information in respect of Product that they believe may lead to a Remedial Action, then it shall promptly inform the other Party’s primary contact on the Product incident review team. Upon such notice, the Product incident review team shall promptly meet to consider the appropriate action. Each Party shall cooperate fully with the other with respect to the consideration of any such matter. If the Product incident review team cannot agree upon how to proceed, such matter shall be escalated to the head of quality for each Party (or his or her designee) for determination. In the event of a deadlock on such matter, GSK will have the right to make the decision; except that, after such deadlock, GSK shall commence the proposed Remedial Action in the Licensed Territory upon Impax’s request, notwithstanding such deadlock, if Impax reasonably believes that the proposed Remedial Action is appropriate due to Impax’s nonconformance with cGMP requirements. Notwithstanding any provision in this Supply Agreement to the contrary, including this Section 6.7, GSK shall not be required to commence any Remedial Action (including, without limitation, Remedial Action requested by Impax), that would violate applicable Laws in any jurisdiction in the Licensed Territory. The conduct of any Remedial Action will be handled in accordance with the Quality Agreement. For the avoidance of doubt, none of the Alliance Managers, Joint Steering Committee or Joint Patents Committee shall have any responsibility for decisions in respect of a Remedial Action. Without limiting the generality of the foregoing, with respect to Remedial Action, each Party shall: (i) Inform the other Party immediately of any defect found, subsequent to release, which may be grounds to initiate a Remedial Action; (ii) Maintain a procedure to cover Remedial Action, including contact arrangements for hours falling outside the typical Business Day; (iii) Provide all support reasonably necessary to support any investigation and subsequent actions in connection with Remedial Action; and (iv) Maintain component traceability records of Products for the periods required by the Quality Agreement, cGMPs or Laws, enabling traceability at the Product batch number level to customers of the Products supplied by Impax.
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Certain Product Events. (a) The Parties shall establish In the event that DENDREON is required by a joint product incident review team Governmental Body or Regulatory Authority or voluntarily decides to consider any proposed Remedial Action initiate a recall, withdrawal or field correction of, field alert report or comparable report with respect to, any product incorporating Product manufactured by GSK pursuant to Product this Agreement, DENDREON shall notify GSK and GSK shall fully cooperate with DENDREON to implement the same. DENDREON shall make all contacts with Regulatory Authorities and shall be responsible for coordinating all of the necessary activities in connection with any such recall, withdrawal or field correction, field alert report or comparable report, and shall make all statements to the Licensed Territorymedia, including, but not limited to press releases and interviews for publication or broadcast. If either Party is aware of a defectGSK agrees to make no statement to the media, incident Governmental Body or other information Regulatory Authority, unless otherwise required by law, and in respect of Product that they believe may lead to a Remedial Actionsuch event, then it GSK shall promptly inform the other Party’s primary contact collaborate with DENDREON on the Product incident review team. Upon such notice, the Product incident review team shall promptly meet to consider the appropriate action. Each Party shall cooperate fully with the other with respect to the consideration content of any such matterstatement, but only to the extent permitted by Legal Requirements and/or Regulatory Acts. If GSK shall be free to make contacts with Regulatory Authorities and Governmental Bodies relating to the Suite generally or other products manufactured in the Suite. DENDREON shall be responsible for all costs associated therewith unless the recall, withdrawal, or field correction, field alert report or comparable report is initiated because of a defect in the Product incident review team cannot agree arising from GSK’s gross negligence or intentional misconduct in the manufacture of the Product by GSK in which case GSK will pay for out-of-pocket costs and administrative costs actually incurred by DENDREON to Third Parties for transportation and destruction of the recalled product incorporating the Product upon how to proceed, receipt of substantiation of such matter shall be escalated costs. GSK will notify DENDREON of any new product developments or introductions or any changes to the head of quality for each Party (or his or her designee) for determinationSuite that may have a significant impact on the Product. In the event of a deadlock on such matter, GSK will have the right to make the decision; except that, after such deadlock, GSK shall commence the proposed Remedial Action in the Licensed Territory upon Impax’s request, notwithstanding such deadlock, if Impax reasonably believes that the proposed Remedial Action is appropriate due to Impax’s nonconformance with cGMP requirements. Notwithstanding any provision in this Supply Agreement to the contrary, including this Section 6.7, GSK shall not be required to commence any Remedial Action (including, without limitation, Remedial Action requested by Impax), that would violate applicable Laws in any jurisdiction in the Licensed Territory. The conduct of any Remedial Action will be handled in accordance [***] Denotes confidential information omitted and filed separately with the Quality Agreement. For the avoidance of doubt, none of the Alliance Managers, Joint Steering Committee or Joint Patents Committee shall have any responsibility Securities and Exchange Commission pursuant to a request for decisions in respect of a Remedial Action. Without limiting the generality of the foregoing, with respect to Remedial Action, each Party shall:
(i) Inform the other Party immediately of any defect found, subsequent to release, which may be grounds to initiate a Remedial Action;
(ii) Maintain a procedure to cover Remedial Action, including contact arrangements for hours falling outside the typical Business Day;
(iii) Provide all support reasonably necessary to support any investigation and subsequent actions in connection with Remedial Action; and
(iv) Maintain component traceability records of Products for the periods required by the Quality Agreement, cGMPs or Laws, enabling traceability at the Product batch number level to customers of the Products supplied by Impaxconfidential treatment.
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