Product Recalls and Withdrawals. Each party shall promptly notify the other party of any legal and/or factual circumstances which might, under applicable laws and regulations, necessitate a field correction, recall or withdrawal of any Products (collectively, a "Regulatory Recall") and shall consult with each other regarding the appropriate steps to be taken. Novartis shall determine whether any Regulatory Recall shall take place. Novartis shall notify all regulatory authorities of any such Regulatory Recall, and shall take all steps necessary to effectuate such Regulatory Recall. LecTec shall assist Novartis in each of these activities to the extent reasonably requested by Novartis. LecTec shall reimburse Novartis for the costs of any such Regulatory Recall to the extent such Regulatory Recall was made necessary by the actions or inaction of LecTec. If LecTec is unable in good faith to obtain the recall insurance required by Section 10.4.6 for a reasonable premium, then the maximum amount which LecTec shall be required to reimburse Novartis pursuant to the preceding sentence shall be $500,000 per Regulatory Recall, not including the cost of any replacement Products made necessary by the applicable Regulatory Recall. Novartis shall reimburse LecTec for the costs of any such Regulatory Recall to the extent such Regulatory Recall was made necessary by the actions or inaction of Novartis. Any claim for such reimbursement of costs incurred in such a Regulatory Recall shall be subject to audit by the CPA Firm.
Product Recalls and Withdrawals. In the event that a Party becomes aware that a Licensed Product in the Field in the Territory may not comply with Law (either by notification from a Regulatory Authority or otherwise) and/or that a Recall of Licensed Product in the Field in the Territory is reasonably anticipated, necessary or desirable, such Party shall promptly notify the other Party in writing. If Athenex is the Party that first becomes aware of the necessity/desirability of a Licensed Product Recall in the Field in the Territory, Athenex shall provide Almirall with the notice described above and upon receipt of such notification (or in the event that Almirall is the first Party to become aware of the necessity/desirability of a Recall in the Field in the Territory), Almirall shall undertake an appropriate investigation and make a determination with respect to the disposition of any such matter, including determining whether Licensed Product in the Field shall be Recalled in the Field in the Territory. If a Recall is required or reasonably necessary pursuant to the Regulatory Authorities or Law or Almirall determines that Licensed Product shall be Recalled in the Field in the Territory, Almirall shall develop and implement a Commercially Reasonable plan to conduct such Recall. Subject to any applicable terms of the Supply Agreement, Almirall shall bear all costs and expenses associated with conducting any Recall in the Field in the Territory (including any reasonable, documented direct costs and expenses incurred by Athenex), except to the extent such Recall results from the negligence or intentional misconduct of Athenex, its Affiliates or their subcontractors, including by way of Athenex, its Affiliates’ or their subcontractors’ failure to manufacture the Licensed Product in accordance with the Supply Agreement, in which case Athenex shall bear all reasonable, documented direct costs and expenses incurred with respect to the conduct of such Recall. EXECUTION DRAFT
Product Recalls and Withdrawals. 11.1 The Supplier shall notify the Company immediately if the Supplier:
Product Recalls and Withdrawals. In the event that, due to a Product recall or withdrawal, the Product is no longer sold in such country, then Baseline Residual Sales shall be adjusted downward to offset the loss of sales in such country. Such adjustment for such country shall be at that percentage level set forth in Schedule 8.7(b) opposite the name of such country. For example, in the event the Product were no longer being sold in Germany, Baseline Residual Sales would be reduced by [ * ], and would only be subject to upward adjustment thereafter as provided in Section 8.7(a). [ * ]
Product Recalls and Withdrawals. Except as set forth on Schedule 4.1(z), since January 1, 1993, there have been no recalls or withdrawals of Inventory produced or sold by the Company or any of its Subsidiaries or other similar federal, state or private actions with respect to such Inventory and, to the knowledge of the Company, no facts or circumstances exist that could reasonably be expected to result in such actions.
Product Recalls and Withdrawals. With respect to each of the products sold by or on behalf of the Company or any of its Subsidiaries, there has not been since September 30, 2008 any recall or withdrawal (either voluntary or involuntary), or claims relating to any recall or withdrawal of products, involving, individually or in the aggregate, in excess of $5,000,000 in book value.
Product Recalls and Withdrawals. As of the date hereof, except as set forth on Schedule 7.24, since April 1, 2000, there have been no recalls or withdrawals of products produced or sold by any Acquired Company.
Product Recalls and Withdrawals. In the event that a Party becomes aware that a Product may not comply with applicable law, rules or regulations (either by notification from a Regulatory Authority or otherwise) in the Territory and/or that a recall or withdrawal of a Product in the Territory is desirable, such Party shall promptly notify the other Party. Promptly after Endo receives such notice from Alexza (if Alexza is the Party that first becomes aware of the necessity/desirability of a Product recall or withdrawal) or promptly after Endo first becomes aware of the necessity/desirability of a Product recall or withdrawal (if Endo is the Party that first becomes so aware), Endo shall undertake an appropriate investigation, give good faith consideration to all substantive comments provided by Alexza, and make a determination with respect to the disposition of any such matter, including determining whether the applicable Product in the Territory shall be recalled or withdrawn. If Endo determines that a Product in the Territory shall be recalled, Endo shall develop and implement a plan to conduct such recall. The Party that is predominantly responsible for the applicable Product’s non-compliance with applicable laws, rules and regulations shall bear all costs and expenses associated with conducting such recall in accordance with such recall plan, unless such recall results predominantly from the other Party’s material breach of its obligations under this Agreement or unless such recall otherwise predominantly results from the gross negligence or wrongful intentional acts or omissions of the other Party, in which case the other Party shall bear all costs and expenses associated with such recall. In all cases, each Party shall use Commercially Reasonable Efforts to implement any recall of any Product in the Territory.
Product Recalls and Withdrawals. Except as set forth on Schedule 4.18, during the three years preceding the date of this Agreement, there have been no recalls or withdrawals of goods or products produced or sold by the Business or other similar federal, state or private actions with respect to such goods or products and, to the Knowledge of Seller, no facts or circumstances exist that could reasonably be expected to result in such actions.
Product Recalls and Withdrawals. In the event that, due to a Product recall or withdrawal, the Product is no longer sold in such country, then Baseline Residual Sales shall be adjusted downward to offset the loss of sales in such country. Such adjustment for such country shall be at that percentage level set forth in Schedule 8.7(b) opposite the name of such country. For example, in the event the Product were no longer being sold in Germany, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Baseline Residual Sales would be reduced by [ * ], and would only be subject to upward adjustment thereafter as provided in Section 8.7(a). [ * ].
