Field Actions. 14.1 The Company will be responsible for the initiation of any recalls or other field actions related to the Products.
Field Actions. (a) Any Field Action with respect to an Alliance Product identified in Section 4.1 as having been an Existing Product will be the sole responsibility and at the sole cost of the Party that provided the Existing Product to the Alliance Program for the entire duration in which such product is an Alliance Product; provided, however, in the event the Parties determine that such Field Action is as a result of the gross negligence of the other Party, then in such case, the other Party will be solely responsible for any Field Action resulting from such gross negligence and at such Party’s sole cost. For purposes of this Agreement, “
Field Actions. If either Party in good faith determines that a removal, correction, recall or other Field Action involving a Product or its labeling is warranted (whether or not required by a Regulatory Authority), such Party shall immediately notify the other Party in writing and shall advise such other Party of the reasons underlying its determination that a removal, correction, recall or other Field Action is warranted. The Parties shall consult with each other as to any action to be taken in regard to such removal, correction, recall or other Field Action. If, after consultations, either Party in good faith believes that such a removal, correction, recall or Field Action should be undertaken with respect to the Product or its labeling, the Parties shall cooperate in carrying out the same, and Zxxxxx shall follow any reasonable direction for X-spine with respect thereto. X-spine shall be responsible for all of Zxxxxx’x reasonable out-of-pocket costs and expenses, including the replacement cost of the Products, in the event of removals, corrections, recalls or other Field Actions with respect to any Product except to the extent such removal, correction, recall or other Field Action was due to an act or omission of Zxxxxx in which case Zxxxxx shall be responsible for X-spine’s reasonable out-of-pocket costs and expenses in connection therewith. X-spine shall be responsible for any required reporting to Regulatory Authorities with respect to any removal, correction, recall or other Field Action involving the Product or its labeling.
Field Actions. For each Territory Supplier shall have the sole discretion and responsibility to effect and control any recall, withdrawal, or field correction (a “Field Action”) with respect to any Product sold on or after the Commencement Date. In connection with a Field Action, Distributor (or such of its Affiliates that holds the product registration with respect to such Product at the time of such Field Action, as applicable) shall reasonably cooperate with responding to Supplier’s requests for information or other assistance, and in otherwise effecting such Field Action by Supplier, and, for clarity, Distributor shall have the right to take any actions as may be necessary or appropriate in connection with applicable Laws in the Territories upon good faith advance communication to Supplier and using commercially reasonable methods (including costs and expenses in furtherance of such methods), in each case at the Supplier’s cost. For clarity, solely with respect to such actions in the applicable Territory in connection with a Field Action that Supplier, the Supplier Affiliates and their respective agents (other than Distributor or Distributor Affiliates) are prohibited from taking and Distributor or a Distributor Affiliate is required to take pursuant to applicable Laws, the Parties shall cooperate with respect thereto, and Supplier shall reasonably assist Distributor or the Distributor Affiliate to take such actions, and any costs and expenses associated with such discussed and agreed upon actions shall be borne by Supplier. Supplier shall consult with Distributor before issuing any press release or otherwise making any public statement regarding any Field Action that references or implicates Distributor or any of its Affiliates. Supplier shall be responsible for communicating with any Governmental Authorities in connection with a Field Action, and Distributor (or such of its Affiliates that holds the product registration with respect to such Product at the time of such Field Action, as applicable) shall reasonably cooperate with Supplier to facilitate such communications (including by communicating directly with the applicable Governmental Authority to the extent so required). Supplier shall bear the costs and expenses to the extent incurred by it and by Distributor or any of its Affiliates in connection with any such Field Action.
Field Actions. For each Region Service Recipient shall have the sole discretion and responsibility to effect and control any recall, withdrawal, or field correction (a “Field Action”) with respect to any Product sold on or after the Region Effective Date. In connection with a Field Action, Service Provider (or such of its Affiliates that holds the product registration with respect to such Product at the time of such Field Action, as applicable) shall reasonably cooperate with responding to Service Recipient’s requests for information or other assistance, and in otherwise effecting such Field Action, in each case at the Service Recipient’s cost. Service Recipient shall consult with Service Provider before issuing any press release or otherwise making any public statement regarding any Field Action that references or implicates Service Provider or any of its Affiliates. Service Recipient shall be responsible for communicating with any Governmental Authorities in connection with a Field Action, and Service Provider (or such of its Affiliates that holds the product registration with respect to such Product at the time of such Field Action, as applicable) shall reasonably cooperate with Service Recipient to facilitate such communications (including by communicating directly with the applicable Governmental Authority to the extent so required). Service Recipient shall bear the costs and expenses to the extent incurred by it and by Service Provider or any of its Affiliates in connection with any such Field Action.
Field Actions. 1.17.1. GenMark shall have the sole discretion to initiate and manage any Field Action.
Field Actions a. Each party shall promptly notify the other party hereto of any known recall related to Products provided by Zeus to Customer.
Field Actions. Nevro has the sole authority for decisions related to any Product(s) in the field, including any Field Action. Suppler shall support Nevro by providing access to necessary Product information and quality records. o x x
Field Actions. 14.1 The Company will be responsible for the initiation of any recalls or other field actions related to the Products. [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.
Field Actions. If any Regulatory Authority issues or requests that a Field Action be conducted with respect to any Product, or if either Party notifies the other that, in its opinion, an event has occurred or circumstance arisen by reason of which such a Field Action may be necessary, then the Parties shall share all relevant facts and information within two Business Days. Thereafter, the Parties shall proceed in accordance with the Quality Agreement.
