Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that a Product does not comply with applicable rules and regulations in such country, ERS shall notify the Company immediately. The JCC shall conduct any appropriate investigation and shall make a determination as to the disposition of any such matter. If ERS is required or if the JCC should deem it appropriate to recall any Product, the Company and ERS shall bear the costs and expenses associated with such recall, in North America in the proportion of 39% for the Company and 61% for ERS, and in Japan in the proportion for which such Party is entitled to receive Operating Profit or Loss, as the case may be, unless: (i) the predominant cause of such recall results from or also constitutes the Company's breach of its representation and/or warranty set forth in Section 11.2(e) and/or ERS's reliance upon such breached representation and/or warranty, or unless the predominant cause of such recall results from the Company's willful wrongdoing or negligence, in each such case the Company shall bear all costs and expenses associated with such recall; or (ii) the predominant cause of such recall results from ERS's willful wrongdoing or negligence, in which case ERS shall bear all costs and expenses associated with such recall.
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that the Product does not comply with applicable rules and regulations in such country, R-Pharm shall notify Scynexis immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If R-Pharm is required or should deem it appropriate to recall the Product and such recall is due to any gross negligence, recklessness or wrongful intentional acts or omissions by, or breach of representation and warranty, including representations and warranties set forth in the Section 2 of this Agreement, by Scynexis, then and in such event Scynexis shall bear all reasonable costs associated with such recall, including, without limitation, refund of the selling price and the actual cost of conducting the recall in accordance with the recall guidelines of the applicable Regulatory Authority. Otherwise, R-Pharm shall bear all costs and expenses associated with such recall. [*] = 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.
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory or ROW shall allege or prove that the Product does not comply with applicable rules and regulations in such country, DUSA shall notify medac immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If DUSA is required or should deem it appropriate to recall the Product and such recall is due to any negligence, recklessness or wrongful intentional acts or omissions by, or strict liability of, or breach of representation and warranty including, but not limited to, non-compliance with cGMP, by, medac, then and in such event medac shall bear all reasonable [ * ] associated with such recall, [ * ]. Otherwise, DUSA shall [ * ].
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that the Product does not comply with applicable rules and regulations in such country, Santen shall notify Inspire immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If Santen is required or should deem it appropriate to recall the Product and such recall is due to any negligence, recklessness or wrongful intentional acts or omissions by, or strict liability of, or breach of representation and warranty by, Inspire, then and in such event Inspire shall bear all reasonable direct costs associated with such recall, including, without limitation, refund of the selling price and the actual cost of conducting the recall in accordance with the recall guidelines of the applicable Regulatory Authority. Otherwise, Santen shall bear all costs and expenses associated with such recall.
Investigation; Recall. 50 12.2 Indemnification by ERS and BMS..............................50 12.3 Indemnification by the Company..............................50 12.4
Investigation; Recall. In the event that the Regulatory Authority in the Territory shall allege or prove that a Product, Finished Product, Implanter or, if Commercialized hereunder, Implant Kit does not comply with applicable rules and regulations in the Territory, Endo shall notify DURECT immediately. The JEC upon the recommendation of the JMC, in consultation with the JCC, shall conduct any appropriate investigation and shall make a determination as to the disposition of any such matter. If Endo is required or if the JEC upon the ***Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC. recommendation of the JMC should deem it appropriate to conduct any recall DURECT and Endo shall bear the costs and expenses associated with such recall, in the proportion of [* * *] for DURECT and [* * *] for Endo, unless: (i) the predominant cause of such recall results from DURECT’s failure to provide Product, Finished Product, Implanters or, if Commercialized hereunder, Implant Kits in accordance with this Agreement, or unless the predominant cause of such recall results from DURECT’s breach of this Agreement or willful wrongdoing, recklessness or gross negligence, in each such case DURECT shall bear all costs and expenses associated with such recall; or (ii) the predominant cause of such recall results from Endo’s breach of this Agreement or willful wrongdoing, recklessness or gross negligence, in which case Endo shall bear all costs and expenses associated with such recall.
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that the Product does not comply with applicable rules and regulations in such country, R-Pharm shall notify Scynexis immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If R-Pharm is required or should deem it appropriate to recall the Product and such recall is due to any gross negligence, recklessness or wrongful intentional acts or omissions by, or breach of representation and warranty, including representations and warranties set forth in the Section 2 of this Agreement, by Scynexis, then and in such event Scynexis shall bear all reasonable costs associated with such recall, including, without limitation, refund of the selling price and the actual cost of conducting the recall in accordance with the recall guidelines of the applicable Regulatory Authority. Otherwise, R-Pharm shall bear all costs and expenses associated with such recall.
Investigation; Recall. In the event that the Supplied Product supplied hereunder, or any portion thereof, should be alleged or proven not to meet the applicable Specifications, applicable Manufacturing Standards or other applicable mandatory standards for same, Kissei shall notify Inspire immediately, and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. Each Party shall bear all costs and expenses associated with any Product recall that is due to or arises from an act or omission with respect to which such Party has an obligation to provide indemnification under Section 11 of the License Agreement.
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that the Product does not comply with applicable rules and regulations in such country, Kirin shall notify Inspire immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If Kirin is required or should deem it appropriate to recall the Product and such recall is due to any negligence, recklessness or wrongful intentional acts or omissions by, or strict liability of, or breach of representation and warranty by, Inspire, then and in such event Inspire shall bear all reasonable direct costs associated with such recall, including, without limitation, refund of the selling price and the actual cost of conducting the recall in accordance with the recall guidelines of the applicable Regulatory Authority. Otherwise, Kirin shall bear all costs and expenses associated with such recall.
Investigation; Recall. In the event that the Regulatory Authority in any country in the Territory shall allege or prove that an I-125 Product does not comply with applicable rules and regulations in such country, the Party so notified by the Regulatory Authority shall notify the other Party immediately. Oncura shall conduct any appropriate investigation and shall make a determination as to the disposition of any such matter. If a Party is required or if Oncura should deem it appropriate to recall any I-125 Product, Oncura shall bear the costs and expenses associated with such recall, unless: the predominant cause of such recall results from IsoRay's willful wrongdoing or negligence, in which case IsoRay shall bear all costs and expenses associated with such recall.
