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 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 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 ***] Confidential Treatment Requested 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 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 Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL TREATMENT REQUESTED 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 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 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 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.