Field Actions. 14.1 The Company will be responsible for the initiation of any recalls or other field actions related to the Products.
14.2 Both parties will comply with recalls or general corrective actions, provided such recalls or general corrective actions do not, in the opinion of Company violate or cause Company to violate the laws of any jurisdiction affected by the recalls or corrective action.
14.3 If Distributor and Company do not agree on a course of action, Company may initiate field actions related to the Products, but may not use field action to cause Distributor to lose Customers.
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 Action” means any product quality related communication to a customer or recall of the Alliance Product. In each instance, the Party responsible for the Field Action will consult with the other Party in as much in advance of the Field Action as is commercially reasonable.
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. 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. 1.17.1. GenMark shall have the sole discretion to initiate and manage any Field Action.
1.17.2. Each Party agrees to notify the other immediately in the event either sees a potential need for a Field Action.
1.17.3. In connection with any such Field Action, LBS shall promptly respond to GenMark’s reasonable requests for documents, information, or other assistance in implementing any such Field Action.
1.17.4. GenMark shall maintain and require its distributors to maintain, such records which will allow for the traceability of all received and distributed Products in the event of any such Field Action.
1.17.5. LBS shall maintain such records, as detailed in the Device Master Record, to allow for the traceability of materials and components used in all lots/batches of finished Product in the event of any such Field Action.
Field Actions. If either Party in good faith determines that a Field Action involving a Product or its labeling is warranted (whether or not required by a Regulatory Authority), such Party will immediately notify the other Party in writing and will advise the other Party of the reasons underlying its determination that a Field Action is warranted. The Parties will consult with each other as to any action to be taken in regard to such Field Action. If, after consultation, either Party in good faith believes that a Field Action should be undertaken with respect to a Product or its labeling, the Parties will cooperate in carrying out the same. The Company will be responsible for all of Xxxxxx’x reasonable out of pocket costs and expenses, including the cost of the Products and the replacement cost of the Products, in the event of Field Action with respect to any Product unless such Field Action was due to an intentional act or omission of Xxxxxx. The Company will be responsible for any required reporting to Regulatory Authorities with respect to any Field Action involving a Product or its labeling.
Field Actions a. Each party shall promptly notify the other party hereto of any known recall related to Products provided by Zeus to Customer.
b. The parties shall reasonably cooperate in connection with investigating and carrying out any recall related to Products provided by Zeus to Customer hereunder.
c. Neither party shall publicly communicate information pertaining to any recall related to Products provided by Zeus to Customer without prior written approval of the other party. If such other party fails to provide a reasonable objection to such proposed public communication within fourteen (14) days, such party proposing to publicly communication such information may make such public communication at any time after such fourteen (14) day period.
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 the Product or its labeling, the Parties shall cooperate in carrying out the same. Tutogen shall be responsible for all of Xxxxxx'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 unless such removal, correction, recall or other Field Action was due to an act or omission of Xxxxxx, in which case Xxxxxx shall be responsible for Tutogen's reasonable out-of-pocket costs and expenses in connection therewith. Tutogen 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. 15.1 RTI will be responsible for the initiation of any Field Actions related to the Implants.
15.2 RTI will notify Zimmer Regulatory Compliance to request cooperation with any Field Action that affect an Implant Distributed by Zimmer. RTI will ensure that any Field Actions comply with the requirements of the FDA and/or applicable international Regulatory Authorities. If it was caused primarily by the negligent (or more culpable) action (including misstatements) or omission by Zimmer or one of its Affiliates or Marketing Partners, then Zimmer shall bear the related expense; otherwise, RTI shall reimburse Zimmer for Xxxxxx’x reasonable expenses and either replace the affected Implants free of charge or, at Xxxxxx’x election, refund to Zimmer the entire Fee paid for the affected Implants. RTI shall be responsible for any required reporting to Regulatory Authorities.
15.3 Zimmer will comply with any recall or general corrective actions initiated by RTI involving the Implants, provided such recalls or general corrective actions do not, in the opinion of Zimmer, violate or cause Zimmer to violate the laws of any jurisdiction affected by the recalls or corrective actions.
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. ¨ x x
