Common use of Recall, Withdrawal, or Market Notification of Product Clause in Contracts

Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority suggests, threatens, recommends or initiates any action to remove the Product from the market whether in the Co-Commercialization Territory or in the COMPANY Territory (in whole or in part, including in clinical Trials), the Party receiving notice thereof shall notify the other Party of such communication promptly, but in no event later than [***], after receipt thereof. Notwithstanding the foregoing, in all cases MorphoSys shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Co-Commercialization Territory, and COMPANY shall determine whether to initiate any such recall, withdrawal or market notification of the Product in the COMPANY Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however, that before MorphoSys or COMPANY (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor and each Party shall take the other Party’s comments under good faith consideration; further provided, that such discussions shall not delay any action that MorphoSys or COMPANY (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, MorphoSys or COMPANY (as the case may be) shall determine the necessary actions to be taken, and shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonably necessary assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, each Party shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by the other Party, but such other Party shall make the final decision whether the recall, withdrawal or market notification will be initiated in its respective Territory. Each Party shall at all times utilize a batch tracing system which will enable it to identify, on a prompt basis, customers within its Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers. Details of recalls’ management shall be dealt with in the Supply Agreement.

Recall, Withdrawal, or Market Notification of Product. In the event that (i) any Governmental Authority suggests, threatens, recommends threatens or initiates any action to remove recall or withdraw the Product from the market whether in the Co-Commercialization Territory ALFASIGMA Territory, or to cause a market notification (e.g., by requiring the issuance of a “Dear Doctor” letter) in the COMPANY Territory ALFASIGMA Territory, or (ii) ALFASIGMA makes the determination to initiate any action to recall or withdraw the Product from the market in whole the ALFASIGMA Territory, or to cause a market notification in partthe ALFASIGMA Territory, including in clinical Trials)then to the extent legally permitted, the Party receiving notice thereof ALFASIGMA shall notify the other Party and consult with IPI promptly and without delay after receipt of such communication promptlyand prior to making any determination to initiate any such action, but in no event later than [***]as applicable. Subject to such consultation and giving due consideration to any comments provided by IPI, after receipt thereof. Notwithstanding the foregoing, in all cases MorphoSys ALFASIGMA shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Co-Commercialization Territory, and COMPANY shall determine whether to initiate any such recall, withdrawal or market notification of the Product in the COMPANY Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however, that before MorphoSys or COMPANY (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor and each Party shall take the other Party’s comments under good faith consideration; further provided, that such discussions shall not delay any action that MorphoSys or COMPANY (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notificationProduct. In the event of any such recall, withdrawal or market notification, MorphoSys or COMPANY (as the case may be) shall determine the necessary actions to be taken, and shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonably necessary assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, each Party shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by the other Party, but such other Party shall make the final decision whether the recall, withdrawal or market notification will be initiated in its respective Territory. Each Party ALFASIGMA shall at all times utilize a batch tracing system which will enable it the Parties to identify, on a prompt basis, customers within its Territory who have been supplied with Product of any particular batch, and to recall such batch of Product from such customerscustomers as set forth in this Section 4.11. Details of recalls’ management Any and all costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product shall be dealt with borne by ALFASIGMA, except for any recall, withdrawal or market notification due to the Compound Manufactured by IPI, in which case IPI shall bear any and all such costs and expenses of such recall up to the price of the Compound. This limitation of costs and expenses borne by IPI shall not apply in the Supply Agreementevent of willful misconduct or gross negligence on the part of IPI (or its Affiliates or Third Party Manufacturer). In the event of any dispute between the Parties with respect to whose default the recall, withdrawal or market notification of the Product has happened, the Parties shall submit the dispute to an independent third party laboratory of recognized repute within the pharmaceutical industry agreed upon by the Parties, the appointment of which shall not be unreasonably withheld or delayed by either Party. The determination of such laboratory shall be in writing and, in the absence of fraud or manifest error, shall be final and binding upon the Parties for all purposes hereunder. The cost and expense of such independent third party laboratory, together with any documented cost directly borne by the other Party due to any third party laboratory’s requests, shall be paid by the Party resulting in error according to the determination of such third party laboratory and neither Party shall be liable or bound to any further refund or reimbursement of costs.

Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority suggests, threatens, recommends sends a written notice threatening or initiates initiating any action to remove the Product from the market whether in the Co-Commercialization Field whether inside the Territory or in outside the COMPANY Territory (in whole or in part, including in clinical Trials), the Party receiving notice thereof shall notify the other Party of such communication promptlyimmediately, but in no event later than [***]two (2) Business Days, after receipt thereof. Notwithstanding the foregoing, in all cases MorphoSys Kaken shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Co-Commercialization Field in the Territory, and COMPANY Brickell shall determine whether to initiate any such recall, withdrawal or market notification of the Product in the COMPANY Territoryall other cases, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however, that that, before MorphoSys Kaken or COMPANY Brickell (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor and each Party shall take the other Party’s comments under good faith consideration; further providedtherefor, provided that such discussions shall not delay any action that MorphoSys Kaken or COMPANY Brickell (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, MorphoSys Kaken or COMPANY Brickell (as the case may be) ), as the distributor of the Product, shall determine the necessary actions to be taken, and and, shall implement such actionactions, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonably necessary assistance, reasonable assistance to conduct such recall, withdrawal or market notification. Without limiting the foregoing, each Party Brickell shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by the other PartyKaken, but such other Party Kaken shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated in its respective Territoryinitiated. Each Party Kaken shall at all times utilize a batch its existing tracing system which will enable it the Parties to identify, on a prompt basis, identify customers within its the Territory who have been supplied with Product of any particular batchwith. Product, and to recall such Product from such customerscustomers as set forth in this Section 5.5. Details Kaken shall bear the costs and expenses of recalls’ management shall be dealt any recall or withdrawal with respect to the Product in the Supply AgreementField in the Territory (including costs associated with return, recall or destruction of the Products) if the cause of the recall is solely attributable to Kaken and Brickell shall bear the costs and expenses of any recall or withdrawal with respect to the Product in the Field in the Territory (including costs associated with return, recall or destruction of the Products) if the cause of the recall is solely attributable to Brickell. In all other cases, Kaken and Brickell shall share such cost and expense in accordance [***]. For clarity, Brickell (or its designee), as holder of the Regulatory Approval for the Products outside the Field and outside the Territory shall have sole discretion in determining whether to initiate any recall, withdrawal or market notification of the Products outside the Territory (or in the Territory but outside the Field), including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification, and nothing contained herein shall limit or otherwise restrict Brickell’s ability with respect to any such recall or withdrawal or market notification.