Common use of Recalls and Withdrawals Clause in Contracts

Recalls and Withdrawals. In the event that any Regulatory Authority issues or requests a recall, stop sale, field correction or market withdrawal or takes similar action (collectively, “Recalls”) in connection with the Licensed Product or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a Recall of the Licensed Product, the Party notified of or desiring such Recall shall, within twenty-four (24) hours, advise the other Party thereof by telephone (and confirmed by email or facsimile), email or facsimile, at the telephone number, email address or facsimile number for such other Party set forth on Schedule 9.2. Following notification of a Recall, the Parties shall meet to discuss such notification and Recall. Salix shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) in the Field in the Territory and the manner in which any such Recall shall be conducted; and Lupin shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) outside the Territory or inside the Territory outside the Field and the manner in which any such Recall shall be conducted. Each Party shall provide a copy of all related documentation and notices to the other Party forthwith. Each Party shall provide such assistance to the other Party in its investigating and conducting any Recall as such other Party may request. [*] shall bear the expenses of any Recall of the Licensed Product in the Field in the Territory; and [*] shall bear the expenses of any Recall of the Licensed Product outside the Territory or inside the Territory outside the Field; provided, however, that, to the extent any such Recall resulted solely from the other Party’s breach of its obligations hereunder or its gross negligence or willful misconduct, such other Party shall bear the expenses of such Recall.

Recalls and Withdrawals. In the event that any Regulatory Authority issues or requests a recall, stop sale, field correction or market withdrawal or takes similar action (collectively, “Recalls”) in connection with the Licensed Product or in the event either Party determines believes that an event, incident a recall or circumstance has occurred that may result withdrawal of a Product is advisable in the need for a Recall any country of the Licensed ProductTerritory, the Party notified of or desiring such Recall shall, within twenty-four (24) hours, advise it shall promptly consult with the other Party thereof by telephone (with respect thereto. After such consultation, Pfizer will have the sole right and confirmed by email authority to make any decision to initiate a recall or facsimile), email or facsimile, at withdrawal of the telephone number, email address or facsimile number for such other Party set forth on Schedule 9.2. Following notification Product in any country of a Recall, the Parties shall meet to discuss such notification and Recall. Salix shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) in the Field in the Pfizer Commercialization Territory and BioNTech will have the manner in which sole right and authority to make any such Recall shall be conducted; and Lupin shall decide whether decision to conduct any such Recall (except in the case of initiate a government-mandated Recall) outside the Territory recall or inside the Territory outside the Field and the manner in which any such Recall shall be conducted. Each Party shall provide a copy of all related documentation and notices to the other Party forthwith. Each Party shall provide such assistance to the other Party in its investigating and conducting any Recall as such other Party may request. [*] shall bear the expenses of any Recall withdrawal of the Licensed Product in the Field in the Territory; and [*] shall bear the expenses of any Recall country of the Licensed Product outside the Territory or inside the Territory outside the Field; BioNTech Commercialization Territory, provided, however, thatthat in each such case, with respect to (a) any lot or batch of Product manufactured by a Party, its Affiliates or any of their respective subcontractors, in the extent any event that such Recall resulted solely from Party, after consultation with the other Party, determines that such lot or batch of Product should be recalled in one or more countries of the other Party’s breach of its obligations hereunder or its gross negligence or willful misconductCommercialization Territory, it shall so notify such other Party and such other Party shall bear the expenses promptly institute a recall of such Recalllot or batch of such Product, and (b) if the Party that is the MA Holder in a country in the other Party’s Commercialization Territory determines in good faith, after consultation with the other Party and its legal counsel, that a recall is required in such country by applicable Law, it shall so notify such other Party and such other Party shall promptly institute a recall. Subject to the foregoing and Sections 9.2.2, 9.3.1.2, 9.3.2.2 and 16.3, the Commercializing Party will have sole control, responsibility and discretion with respect to implementing any and all such recalls or withdrawals in each country of such Party’s Commercialization Territory, provided that where the Recall Costs are to be borne by the other Party the Commercializing Party shall use Commercially Reasonable Efforts to mitigate any such Recall Costs. The Recall Costs of any such recall or withdrawal will be borne by BioNTech, except to the extent that the recall or withdrawal of Product is attributable to the (i) breach or default of Pfizer or its Affiliates or any of its or their Representatives under this Agreement or in its Manufacturing, handling or storing of the Product that is the subject of the recall or withdrawal, or (ii) negligence or willful misconduct of Pfizer, its Affiliates or any of its or their Representatives, in which event Pfizer will if such recall or withdrawal is in a country in the Pfizer Commercialization Territory, bear or, if such recall or withdrawal is in a country in the BioNTech Commercialization Territory, reimburse BioNTech and its Affiliates for such Recall Costs. If there is any recall or withdrawal, then the Commercializing Party will implement any necessary action, and the other Party will provide any and all assistance as reasonably requested by the Commercializing Party.

Recalls and Withdrawals. In the event that any Regulatory Authority issues or requests a recall, stop sale, field correction or market withdrawal or takes similar action (collectively, “Recalls”) in connection with the Licensed Product or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a Recall of the Licensed Product, the Party notified of or desiring such Recall shall, within twenty-four (24) hours, advise the other Party thereof by telephone (and confirmed by email or facsimile), email or facsimile, at the telephone number, email address or facsimile number for such other Party set forth on Schedule 9.2. Following notification of a Recall, the Parties shall meet to discuss such notification and Recall. Salix shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) in the Field in the Territory and the manner in which any such Recall shall be conducted; and Lupin shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) outside the Territory or inside in the Territory outside the Field and the manner in which any such Recall shall be conducted. Each Party shall provide a copy of all related documentation and notices to the other Party forthwith. Each Party shall provide such assistance to the other Party in its investigating and conducting any Recall as such other Party may request. [*] shall bear the expenses of any Recall of the Licensed Product in the Field in the Territory; and [*] shall bear the expenses of any Recall of the Licensed Product outside the Territory or inside in the Territory outside the Field; provided, however, that, to the extent any such Recall resulted solely from the other Party’s breach of its obligations hereunder or its gross negligence or willful misconduct, such other Party shall bear the expenses of such Recall.