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 Licensed Product sold in the Territory during the Term, or in the event a Betta Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, Betta will advise Agenus thereof by telephone, facsimile or e-mail as promptly as practicable, but at least [*] prior to public disclosure of such recall, market withdrawal or corrective action conducted, except where such advisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, in which case, Betta will advise Agenus thereof as soon as reasonably practicable. Except where it would reasonably be expected to result in Betta’s non-compliance with Applicable Law, Betta, in consultation with Agenus, will decide whether to conduct a recall, market withdrawal or similar action in the Territory and the manner in which any such recall will be conducted. If the Licensed Product that is subject to such recall, market withdrawal or corrective action was supplied by Agenus, Agenus will make available all of its pertinent records that may be [*] by Betta in order to effect a recall in the Territory. Betta will bear all costs and expenses that may be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that to the extent any such recall or withdrawal is due to the failure of the Licensed Products supplied by Agenus to comply with the specifications of the Licensed Product in accordance with the terms and conditions of the Supply Agreement, Agenus will bear all reasonable costs and expenses incurred in connection with such recall or withdrawal.

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 Co-Co Licensed Product sold in the Co-Co Territory during the Termor Genzyme Territory, or in the event a Betta 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 Co-Co Licensed Product in the Co-Co Territory or Genzyme determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Co-Co Licensed Product in the Genzyme Territory, Betta will advise Agenus the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within [***] hours notify the other Party’s CLP Alliance Manager and PJSC representatives thereof by telephone, facsimile telephone or e-mail as promptly as practicable, but at least [*] prior to public disclosure of such recall, market withdrawal or corrective action conducted, except where such advisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, in which case, Betta will advise Agenus thereof as soon as reasonably practicablemail. Except where it would reasonably be expected to result in Betta’s non-compliance with Applicable Law, Betta, in consultation with Agenus, will decide The Parties shall mutually agree whether to conduct a recall, market withdrawal or similar action recall of a Co-Co Licensed Product in the Co-Co Territory and the manner in which any such recall will shall be conducted. If conducted (except in the Licensed Product that is case of a government mandated recall, when the Party subject to such mandate may act without such advance notice but shall notify the other Party as soon as possible). Genzyme shall determine whether to conduct a recall of a Co-Co Licensed Product in the Genzyme Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, market withdrawal or corrective action was supplied when Genzyme may act without such advance notice but shall notify Alnylam as soon as possible). Except as may be otherwise agreed by Agenusthe Parties, Agenus each Party shall share equally the expense of any such recall in the Co-Co Territory and Genzyme shall bear the expense of any such recall in the Genzyme Territory. Each Party will make available all of its pertinent records that may be [*] reasonably requested by Betta the other Party in order to effect a recall in the Territory. Betta will bear all costs and expenses that may be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that to the extent any such recall or withdrawal is due to the failure of the Licensed Products supplied by Agenus to comply with the specifications of the a Co-Co Licensed Product in accordance with the Co-Co Territory or Genzyme Territory. The Parties’ rights and obligations under this Section 4.6 shall be subject to the terms of any supply agreement(s) entered into between the Parties and, in the event of any conflict between the provisions of any such supply agreement and conditions this Section 4.6, the provisions of the Supply Agreement, Agenus will bear all reasonable costs and expenses incurred in connection with such recall or withdrawalsupply 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 or requires or advises a Party or any of their respective Affiliates, Sublicensees or Third Party Distributors to distribute a “Dear Doctor” letter or its equivalent in connection with a Licensed Product sold in the Territory during Field in the TermTerritory, or in the event a Betta 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 Licensed Product in a country in the TerritoryTerritory (each such event, Betta will advise Agenus thereof a “Recall”), the Party notified of such Recall or that determines it may be necessary to initiate such Recall, shall as promptly as possible, notify the other Party by telephone, facsimile telephone or e-mail as promptly as practicable, but at least [*] prior to public disclosure of such recall, market withdrawal or corrective action conducted, except where such advisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, in which case, Betta will advise Agenus thereof as soon as reasonably practicablemail. Except where it would reasonably be expected to result in Betta’s non-compliance with Applicable Law, Betta, in consultation with Agenus, will The Parties shall mutually decide whether to conduct a recall, market withdrawal or similar action Recall of a Licensed Product in the Territory and the manner in which any such recall will Recall shall be conducted. If the Licensed Product Parties cannot agree on how to proceed in light of such potential Recall, then the matter will be resolved in accordance with Section 2.10(c)(iii). Except as may otherwise be agreed to by the Parties or as set forth in any Commercial Supply Agreement, the Parties shall equally bear the expense of any such Recall in the Territory, provided that is subject to the extent that a Recall results from a Party’s breach of its obligations hereunder, or from such recallParty’s or its Affiliates’ or Sublicensees’ gross negligence or willful misconduct, market withdrawal or corrective action was supplied by Agenus, Agenus will such Party shall bear the associated costs of the Recall. Each Party shall make available all of its pertinent records that may be [*] reasonably requested by Betta the other Party in order for a Party to effect affect a recall Recall of a Licensed Product in the Territory. Betta will bear all costs The Parties’ rights and expenses that may obligations under this Section 4.2 shall be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that subject to the extent terms of any such recall applicable Pharmacovigilance Agreement or withdrawal is due to Commercial Supply Agreement entered into between the failure Parties. In the event of a conflict between the Licensed Products supplied by Agenus to comply with the specifications provisions of the Licensed Product in accordance with the terms and conditions of the any Pharmacovigilance Agreement or Commercial Supply Agreement, Agenus will bear all reasonable costs as applicable, and expenses incurred in connection with this Section 4.2, the provisions of such recall Pharmacovigilance Agreement or withdrawalCommercial Supply Agreement, as applicable, 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 Licensed Product sold in the Territory during Field in the TermTerritory, or in the event a Betta 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 Licensed Product in the Field in the Territory, Betta the Party notified of such recall or similar action, or the Party that desires such recall or similar action, will advise Agenus thereof as promptly as possible, notify the other Party by telephone, facsimile telephone or e-mail as promptly as practicable, but at least mail. [**] prior to public disclosure of such recall, market withdrawal or corrective action conducted, except where such advisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, in which case, Betta will advise Agenus thereof as soon as reasonably practicable. Except where it would reasonably be expected to result in Betta’s non-compliance with Applicable Law, Betta, in consultation with Agenus, will decide via the JSC whether to conduct a recall of, market withdrawal of or similar action with respect to a Licensed Product in the Profit-Share Territory and the manner in which such recall, market withdrawal or similar action will be conducted. [**]. Biogen will have the sole right to determine whether and when to conduct a recall of, market withdrawal of or similar action with respect to a Licensed Product in the Biogen Territory and the manner in which any such recall recall, market withdrawal or similar action will be conducted; [**]. If Except as may otherwise be agreed to by the Licensed Product that is subject to Parties, Biogen will bear the costs and expenses of any such recall, market withdrawal or corrective similar action was supplied by Agenus, Agenus to the extent related to the Biogen Territory. Each Party will make available all of its pertinent records that may be [*] reasonably requested by Betta the other Party in order for a Party to effect a recall of a Licensed Product anywhere in the Territory. Betta The Parties’ rights and obligations under this Section 6.9 (Recalls, Market Withdrawals or Corrective Actions) will bear all costs and expenses that may be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that subject to the extent terms of any such recall Pharmacovigilance Agreement or withdrawal is due to Supply Agreement entered into between the failure Parties. In the event of a 60 conflict between the Licensed Products supplied by Agenus to comply with the specifications provisions of the Licensed Product in accordance with the terms and conditions of the any Pharmacovigilance Agreement or Supply Agreement, Agenus as applicable, and this Section 6.9 (Recalls, Market Withdrawals or Corrective Actions), the provisions of such Pharmacovigilance Agreement or Supply Agreement, as applicable, will bear all reasonable costs and expenses incurred in connection with such recall or withdrawalgovern.