Recalls and Withdrawals. Unless otherwise required by Applicable Law, Licensee shall not institute a recall or other market withdrawal of Licensed Product without first providing prior written notice to MPP and Pfizer, such notice to set forth the basis of the recall and market withdrawal. In the event that Licensee receives any notice from an Agency requesting or otherwise directing Licensee to initiate a recall or other market withdrawal of Licensed Product, Licensee shall immediately, but in any event within twenty-four (24) hours of its receiving such notice, provide any such notice to MPP and Pfizer. Notwithstanding the obligations set forth herein, Licensee shall be solely responsible and liable for any recall or other market withdrawal of Licensed Product and in no event shall Pfizer or MPP have any liability with respect thereto.
Recalls and Withdrawals. Unless otherwise required by Applicable Law, Licensee shall not institute a recall or other market withdrawal of Licensed Product without first providing prior written notice to MPP and Pfizer, such DocuSign Envelope ID: 20ED8EAA-71E5-4C18-B49D-62DBEC763D25 notice to set forth the basis of the recall and market withdrawal. In the event that Licensee receives any notice from an Agency requesting or otherwise directing Licensee to initiate a recall or other market withdrawal of Licensed Product, Licensee shall immediately, but in any event within twenty-four (24) hours of its receiving such notice, provide any such notice to MPP and Pfizer. Notwithstanding the obligations set forth herein, Licensee shall be solely responsible and liable for any recall or other market withdrawal of Licensed Product and in no event shall Pfizer or MPP have any liability with respect thereto.
Recalls and Withdrawals. Subject to the terms and conditions of the Supply Agreement, Auxilium shall have sole responsibility for and shall make all decisions with respect to any recall, market withdrawals or any other corrective action related to the Products labeled for use in the Field in the Territory; provided however, (i) Auxilium shall immediately notify BTC of any decision to initiate a recall or withdrawal of such Product; (ii) all costs and expenses with respect to a recall, market withdrawal or other corrective action for such Product shall be borne by Auxilium unless such recall, market withdrawal or other corrective action was due to the negligence, willful misconduct or material breach of this Agreement or the Supply Agreement by BTC; and (iii) BTC shall immediately notify Auxilium of any decision to initiate a recall or withdrawal of a Product outside of the Field. Each Party shall provide the other Party with recall information received by it in sufficient detail to allow the Parties to comply with Law.
Recalls and Withdrawals. In the event that either Party believes that a recall or withdrawal of a Product is advisable in any country of the Territory, it shall promptly consult with the other Party with respect thereto. After such consultation, Pfizer will have the sole right and authority to make any decision to initiate a recall or withdrawal of the Product in any country of the Pfizer Commercialization Territory and BioNTech will have the sole right and authority to make any decision to initiate a recall or withdrawal of the Product in any country of the BioNTech Commercialization Territory, provided, however, that 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 event that such 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 Commercialization Territory, it shall so notify such other Party and such other Party shall promptly institute a recall of such lot 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, be...
Recalls and Withdrawals. 4.4.1 As used in this Section 4.4, “recall” means a safety recall of one or more lots of Licensed Product due to concerns specific to such lots, and “withdrawal” means the removal of a Licensed Product from the market entirely.
Recalls and Withdrawals. In the event that any Regulatory Authority orders or requests a recall, stop sale, field correction or market withdrawal or takes similar action (collectively, “Recalls”) in connection with a Licensed Product or in the event ViroPharma determines that an event, incident or circumstance has occurred that may result in the need for a Recall of a Licensed Product, ViroPharma shall promptly advise INS. ViroPharma shall decide whether to conduct any such Recall (except in the case of a government-mandated Recall) and the manner in which any such Recall shall be conducted, and shall bear the expenses of any Recall.
Recalls and Withdrawals. Company shall immediately notify CDC of any decision to initiate a recall or withdrawal of Product. Any and all costs and expenses of in connection with such recall, market withdrawal or other corrective action shall be borne by Company.
Recalls and Withdrawals. Each of 3i and ORTHOVITA agree that if ----------------------- either party shall discover or become aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to the Product(s)s which may reasonably require recall or market withdrawal of the Product(s), such party shall promptly communicate such fact, condition, circumstance or event to the other party as soon as reasonably practicable. In the event (i) any government entity or regulatory body requests or mandates that the Product(s) be recalled and (ii) the parties agree, after consultation with each other, that the Product(s) shall be recalled or withdrawn from the market, the parties shall take all appropriate remedial actions with respect to such recall or withdrawal of the Product(s).
Recalls and Withdrawals. [*] promptly shall [*] for all costs incurred by [*] in connection with recalls, market withdrawals, and returns and destruction of Product containing any non-conforming Compound (as determined pursuant to Section 2.7(d)) as and to the extent and only to the extent any such recall, market withdrawal or return or destruction of Product is the direct result of [*]’s breach of its warranties under Section 2.6 or [*]’s gross negligence or willful misconduct. [*] shall have the right to offset any such costs against any payments owed by [*] to [*] under this Agreement. All other costs for recalls, market withdrawals and returns and destruction of Product shall be the sole and exclusive responsibility of [*] (including any recalls, market withdrawals and returns * Confidential treatment requested; certain information omitted and filed separately with the SEC. and destruction of Product as and to the extent attributable to the failure of [*] to conform to applicable Specifications).
Recalls and Withdrawals. Lupin promptly shall reimburse Salix for all costs incurred by Salix in connection with recalls, market withdrawals, and returns and destruction of Product as and to the extent such recalls, market withdrawals, and returns and destruction of Product result from Lupin’s breach of its obligations under this Agreement or negligence or willful misconduct. Salix shall have the right to offset any such costs against any payments owed by Salix to Lupin under this Agreement. * Confidential treatment requested; certain information omitted and filed separately with the SEC.
