Corrections and Removals. If the Supplier files a Corrections or Removals for the product, or any similar product that the Supplier provides to the Purchaser, the Supplier shall promptly notify the Purchaser. The Purchaser is responsible for managing corrections or removals of SI-BONE product.
Corrections and Removals. If the Supplier files a Corrections or Removals for the product, or any similar product, the Supplier provides to the Customer, the Supplier shall promptly notify the Customer. The Supplier and the Customer shall cooperate in the exchange of information required to effectively manage the Supplier’s Correction or Removal Report in the Customer’s Corrections and Removals Records.
Corrections and Removals. Only CPI can initiate a correction or removal of product. ZIEN and CPI shall cooperate in the exchange of information required to effectively manage the Correction or Removal Report in the CPI Corrections and Removals Records.
Corrections and Removals. (i) (1) The Steering Committee shall ensure that the Parties establish a coordinated tracking system and appropriate distribution records for all Licensed Products so as to permit successful tracking in the event of a correction or removal (i.e., field action); (2) The Steering Committee shall establish a system to ensure that all corrections and removals are properly reported to the FDA and/or the TPD and proper records kept pursuant to FDA and TPD requirements; (3) if either Party becomes aware of any defect, problem or adverse condition in any Licensed Product, that Party shall promptly concurrently notify the Steering Committee (or its delegate) and the head of Regulatory Affairs for the other Party; (4) the Steering Committee may determine whether a correction or removal involving a Licensed Product is warranted and shall supervise and coordinate any such action, appropriate record keeping and the reporting thereof to the FDA or the TPD, if required; (5) notwithstanding Section 6.5(d)(4), if either Party reasonably believes a correction or removal is necessary, it may initiate such correction or removal and the Steering Committee shall accept that determination as final and the Parties through the Steering Committee shall fully cooperate and coordinate to implement such correction or removal; (6) notwithstanding Section 6.5(d)(5), if both Parties agree through the Steering Committee that a proposed correction or removal would be considered a Class III recall by FDA (in which exposure to violative product is not likely to cause adverse health consequences), then the President/Chief Executive Officers of both Parties shall jointly make a final decision with respect to a Steering Committee deadlock as to whether a correction or removal decision should be taken; if the Presidents/Chief Executive Officers are unable to decide, the matter shall be resolved by Q-Med pursuant to the MIP procedure prior to completion of the procedure set forth in Section 6.2(a) or (b) or 6.3, as applicable, and by the Purchaser under the MIP procedure after the completion of the procedure set forth in Section 6.2 (a) or (b) or 6.3, as applicable; and (7) to the extent a Party is responsible for the underlying cause of a correction or removal such Party shall bear the cost and expenses of the same (including out-of-pocket expenses incurred by the other Party in cooperating with such correction or removal).
Corrections and Removals. (1) The Parties shall establish a coordinated tracking system and appropriate distribution records for all Licensed Products so as to permit successful tracking in the event of a correction or removal (i.e., field action); (2) if either Party becomes aware of any defect, problem or adverse condition in any Licensed Product, whether inside or outside the Territory, that Party shall promptly notify the other Party; (3) Medicis shall determine whether a correction or removal involving a Licensed Product in the Territory is warranted and shall supervise and coordinate any such action, appropriate record keeping and the reporting thereof to the FDA or the TPD, if required; and (4) to the extent a Party is responsible for the underlying cause of a correction or removal such Party shall bear the cost and expenses of the same (including out-of-pocket expenses incurred by the other Party in cooperating with such correction or removal).
