Common use of Recalls, Market Withdrawals or Corrective Actions Clause in Contracts

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation with the other Party, will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 will be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall recall, market withdrawal or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation and will discuss with the other PartyParty the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall recall, market withdrawal or similar action of a Regional Licensed Product in its own Territory and the manner in which any such recall recall, market withdrawal or similar action will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice notice, but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] each Party will bear the expense of any such recall, market withdrawal or similar action in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall recall, market withdrawal or similar action of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 4.8 will be subject to the terms of any supply agreement(s), including any SDEA Pharmacovigilance Agreement or quality related agreements agreement(s) entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA Pharmacovigilance Agreement or quality related agreements and this Section 6.2.74.8, the provisions of such supply agreement, SDEA Pharmacovigilance Agreement or quality related agreements will govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Competent Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possibleshall, within twenty-four (24) hours of such request, order or determination, notify the other Party’s Alliance Manager and JCC representatives thereof JSC members by telephone or e-mail. Each Party, in consultation with the other Party, will shall decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will shall notify the other Party as soon as possible thereafterpossible). Except as may otherwise be agreed to by the Parties, [***] each Party shall bear the expense of any such recall in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its the other Party’s Territory. The Parties’ rights and obligations under this Section 6.2.7 will 2.5.5 shall be subject to the terms of any supply agreement(sParty Supply Agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements Party Supply Agreement and this Section 6.2.72.5.5, the provisions of such supply agreement, SDEA or quality related agreements will Party Supply Agreement shall govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation with the other Party, will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] and subject to the Parties’ respective indemnification obligations hereunder or under any ancillary agreements between the Parties, each Party will bear the expense of any such recall in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order that are necessary for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 6.1.7 will be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.76.1.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any If a Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional any of the Licensed Product Products in a the Territory, or in the event if either Party determines (acting reasonably and in good faith) that an event, incident or circumstance has occurred which results in reasonable grounds for believing that there may result in the need for be an actual or suspected defect with a Licensed Product such that a recall or market withdrawal of a Regional Licensed Product in its Territorythe Territory may be required, the Party notified of such recall or similar action, or the Party that desires believes such recall or similar actionaction is required, will as promptly as possibleshall within [*], notify advise the other Party’s Alliance Manager and JCC representatives Party thereof by telephone or e-mailemail. Each Party, The Parties shall discuss and agree (acting reasonably and in consultation with the other Party, will decide good faith) whether to conduct a recall of a Regional Licensed Product in its own one (1) or more countries in Territory A or Territory B (as applicable) and the manner in which any such recall will shall be conducted (except conducted, provided, however, in the case event of a government ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ ​ Regulatory Authority-mandated recall, when such Party Genmab (in respect of [*]) and Licensee (in respect of [*]) may act without such advance notice but will in any event shall notify the other Party as soon as possible thereafter)reasonably possible. Except In either case, if the Parties cannot agree as may otherwise be agreed to by whether a recall is required in the PartiesTerritory, [***] shall have final decision-making authority with respect to such matter (which shall not be subject to challenge, review or arbitration). Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’ and Subcontractors’ and sublicensees’) pertinent records that such other Party may be reasonably requested by the request to assist such other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territoryeffecting any recall. The Parties’ rights costs and obligations under this Section 6.2.7 will be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions expenses of any such supply agreementrecall shall be taken into account in determining Pre-Tax Profit or Loss as, SDEA or quality related agreements and this Section 6.2.7to the extent, the provisions of such supply agreement, SDEA or quality related agreements will governprovided in Schedule 10.

Recalls, Market Withdrawals or Corrective Actions. In During the Licensed Period, in the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in the Field in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in the Field in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation and will discuss with the other PartyParty the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall of a Regional Licensed Product in the Field in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice notice, but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the PartiesParties in writing, [***] each Party will bear the expense of any such recall of Licensed Products in the Field in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in the Field in its Territory. The Parties’ rights and obligations under this Section 6.2.7 4.7 will be subject to the terms and conditions of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.74.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or withdrawal, or takes a similar action in connection with with, a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager Manager, JSC representatives and JCC applicable quality assurance representatives thereof by telephone or e-mail. Each Party, in consultation and will discuss with the other PartyParty the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall or withdrawal of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice notice, but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] each Party will bear the expense of any such recall or withdrawal in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 4.7 will be subject to the terms and conditions of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.74.7, the provisions of such supply agreement, SDEA or quality related agreements will governgovern with respect to the conflicting provision.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event that either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC JSC representatives thereof by telephone or e-mail. Each Party, in consultation and will discuss with the other PartyParty the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice notice, but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the PartiesParties and subject to Section 11, [***] each Party will bear the expense of any such recall in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 4.7 will be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.74.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, shall within [***] hours notify the other Party’s RLP Alliance Manager and JCC PJSC representatives thereof by telephone or e-mail. Each Party, in consultation with the other Party, will shall decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will shall notify the other Party as soon as possible thereafterpossible). Except as may otherwise be agreed to by the Parties, [***] each Party shall bear the expense of any such recall in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its the other Party’s Territory. The Parties’ rights and obligations under this Section 6.2.7 will 4.7 shall be subject to the terms of any supply agreement(s), including any SDEA or quality related agreements ) entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements agreement and this Section 6.2.74.7, the provisions of such supply agreement, SDEA or quality related agreements will agreement shall govern.

Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Regional Licensed Product in a Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Regional Licensed Product in its Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will as promptly as possible, notify the other Party’s Alliance Manager and JCC representatives thereof by telephone or e-mail. Each Party, in consultation and will discuss with the other PartyParty the reasons for the recall, market withdrawal or similar action. Each Party will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice notice, but will notify the other Party as soon as possible thereafter). Except as may otherwise be agreed to by the Parties, [***] each Party will bear the expense of any such recall in its own Territory. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order for a Party to effect a recall of a Regional Licensed Product in its Territory. The Parties’ rights and obligations under this Section 6.2.7 4.7 will be subject to the terms and conditions of any supply agreement(s), including any SDEA or quality related agreements entered into between the Parties. In the event of a conflict between the provisions of any such supply agreement, SDEA or quality related agreements and this Section 6.2.74.7, the provisions of such supply agreement, SDEA or quality related agreements will govern.