Product Recalls. The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.
Product Recalls. If any Products have been manufactured by or for Supplier in a manner that is inconsistent with Product Specifications or if any Products otherwise do not comply with Supplier’s warranty, and S&W requests Supplier to recall such Products for safety reasons, then Supplier shall determine, under its recall standards, whether a recall of any Products should be made. If Supplier determines that for any reason a recall of such Products should be made, then Supplier shall recall such Products at its own expense. In such case, S&W shall take all reasonable actions requested by Supplier to assist in such a recall. S&W shall not modify or retrofit any Product as part of any recall or retrofit campaign by S&W without Supplier’s prior written consent, which shall not be unreasonably withheld.
Product Recalls. In the event (a) any government authority issues a request, directive or order that the Product be recalled, or (b) a court of competent jurisdiction orders such a recall, or (c) Allergan and Ista, after consultation with each other, determine that the Product should be recalled, or (d) either Allergan or Ista, after consultation with each other, if legally required to make such recall, does so, the parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. Allergan shall handle notification of customers and return of Product from customers. The owner of the relevant regulatory approval shall handle all communications and requests with regulatory agencies regarding any recalls. If such recall results from any cause or event arising from a sole responsibility of Ista as set forth in this Agreement or in the Supply Agreement or is solely attributable to Ista, Ista shall be responsible for all expenses of the recall and Allergan may deduct any such expenses borne by Allergan from any payment due to Ista under this Agreement. If such recall results from a sole responsibility of Allergan as set forth in this Agreement or in the Supply Agreement or is solely attributable to Allergan, Allergan shall be responsible for the expenses of recall and shall reimburse Ista for expenses incurred by Ista for such recall. In the event that the recall results from any cause(s) or event(s) arising from a joint responsibility of the parties or partially from a responsibility of Ista and partially from a responsibility of Allergan, Ista and Allergan shall be jointly responsible for expenses of the recall in proportion to each such party's proximate fault with respect to the recall. If the parties are unable to agree on the allocation of such fault, then such dispute shall be subject to the dispute resolution provisions of Section 15. For the purpose of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Product, cost for the Product recalled, legal expenses, inventory write-offs and penalties resulting from Third Party contracts, but shall not include goodwill, lost profits or other similar intangible or speculative claims.
Product Recalls. (a) In the event: (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; (ii) a court of competent jurisdiction orders such a recall, or (iii) Theravance or Hospira reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall.
Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller or any Affiliate of a Seller, or to the Knowledge of the Sellers, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the Territory, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the Business in the Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers prior to the date of this Agreement.
Product Recalls. In the event that a PRODUCT is recalled from the market for any reason whatsoever, EAGLE shall be responsible for: (a) conducting all recall activities; and (b) all costs associated with any such recall, subject to any indemnification by XXXXXX; provided, however, that notwithstanding anything to the contrary contained in this Agreement, any such costs shall be deducted from Net Sales and retained by EAGLE, prior to the computation of GROSS PROFIT of the PRODUCT. The PARTIES shall keep the other fully informed in writing of any notification or other information, whether received directly or indirectly, that might (i) affect the marketability, safety or effectiveness of any PRODUCT, (ii) result in liability issues or otherwise necessitate action on the part of either party or (iii) result in recall or seizure of any PRODUCT.
Product Recalls. In the event any Regulatory Authority issues or requests a recall or takes similar action with respect to a Licensed Product that CytomX reasonably believes is or may be attributable to or otherwise relates to the Licensed Intellectual Property, or in the event either Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for such a recall, such Party shall promptly notify the other Party thereof by telephone, facsimile or email. Following such notification, CytomX shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or take such other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted, provided that CytomX shall keep ImmunoGen informed regarding any such recall, market withdrawal or corrective action as ImmunoGen from time to time may reasonably request, but only to the extent CytomX is legally permitted to do so. CytomX shall bear all expenses of any such recall, market withdrawal or corrective action, including, without limitation, expenses of notification, destruction and return of the affected Licensed Product and any refund to customers of the amounts paid for such Licensed Product.
Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Co-Developed Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding a Co-Developed Product, such Party shall promptly advise the other Party thereof by telephone or facsimile. Following such notification, Xxxxxx shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided that Xxxxxx shall keep Enanta regularly informed regarding any such recall, market withdrawal or corrective action. Xxxxxx shall bear all expenses of any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification, destruction and return of the affected Co-Developed Product and any refund to customers); provided, that, any such expenses shall be allocable as Co-Developed Costs or Commercialization Expenses and shared by the Parties in accordance with Section 5.3.
Product Recalls. Decisions with respect to recalls, withdrawals or other corrective actions (“Recall”) with respect to any Collaboration Product related to manufacturing or product quality issues shall be handled in accordance with the Commercial Supply Agreement. Decisions with respect to any other Recall related to any Collaboration Product in the Profit Sharing Territory or Royalty Product in its applicable territory shall be made only upon mutual agreement of the Parties; provided, however, that nothing herein shall prohibit either Party from initiating or conducting any Recall (i) mandated by a regulatory authority or applicable law, (ii) which in its reasonable judgment is, or such Party reasonably believes will result in, a Class I or Class II recall (under U.S. Food and Drug Administration regulations or its equivalent outside of the U.S.) or (iii) if a Party is the Independent Development Party in its sole discretion. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such Recall. Except as otherwise provided in this Section 6.10, the Parties will share all costs of a Recall with respect to any Collaboration Product in the Profit Sharing Territory as a Shared Promotion Expense. *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. An Independent Development Party shall bear all costs of a Recall with respect to any Royalty Product in the Royalty Territory. Notwithstanding the foregoing, a Party shall bear any and all costs of a recall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the COGM for the Collaboration Product in question, to the extent the Recall is attributable to the fault of such Party and results from (a) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or sublicensee), (b) the failure of the Manufacturing Party to perform its responsibilities and Manufacture the Collaboration Product in compliance with specifications or with applicable laws, including applicable Good Manufacturing Practices, or (c) a breach of any laws or the terms of this Agreement.
Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding a Product, such Party shall promptly advise the other Party thereof by telephone or facsimile. Following such notification, AstraZeneca shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in 140 which case it shall be required) or to take other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided that AstraZeneca shall keep Targacept regularly informed regarding any such recall, market withdrawal or corrective action. AstraZeneca shall bear all expenses of any such recall, market withdrawal or corrective action (including expenses for notification, destruction and return of the affected Product and any refund to customers of amounts paid for such Product); provided, however, that Targacept shall bear the expense of a recall to the extent that such recall resulted from any breach by Targacept of its obligations hereunder or under the applicable Co-Promotion Agreement or Targacept’s or any of its Affiliates’ negligence or willful misconduct, provided that Targacept shall not be deemed to be negligent or in breach solely for complying with the training provided by AstraZeneca under the applicable Co-Promotion Agreement, with AstraZeneca’s standard operating procedures as may be provided under the applicable Co-Promotion Agreement or otherwise with direction from AstraZeneca if the activities required by such training, procedures or other direction would themselves constitute negligence or breach.
