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: F0C62F1B-BD77-4D06-9219-67924AA8E188 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 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. [*] 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. Any decision to initiate a recall or withdrawal of a Product in a country in a Region shall be made by BMS, after consultation (to the extent practicable) with COLLABORATOR; provided, that if, as a result of patient safety concerns, there is not sufficient time for the Parties to meet, BMS shall determine the strategy for and implement such withdrawal or recall and shall notify and brief COLLABORATOR with respect to such strategy and implementation. BMS shall have final decision‑making authority with respect to any such recall or withdrawal without regard or recourse to the dispute resolution mechanism provided for in Section 2.10(c), Section 13.1 or Section 13.2. The costs of any such recall or withdrawal relating to (a) the Development of a Product for an indication prior to the initial Approval for such indication shall be a Development Cost, and (b) any Phase IV Clinical Trial or Commercialization activities shall be an Allowable Expense, except in either case ((a) or (b)) to the extent that the recall or withdrawal is attributable to the gross negligence or willful misconduct of a Party in which event (i) such Party shall bear such costs for which it is responsible and (ii) such costs shall not be included in Development Costs or Allowable Expenses, as the case may be. In the event of any recall or withdrawal, BMS shall implement any necessary action, with assistance from COLLABORATOR as reasonably requested by BMS. In the event that COLLABORATOR reasonably requests in writing that BMS conduct a recall of a Product in the Territory and BMS has not initiated the recall of such Product within three (3) Business Days after such request (such date, “Recall Deadline”), BMS shall indemnify the COLLABORATOR Indemnitees as set forth in Section 12.1(a)(ii)(B). 104 [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission.
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. 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. 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. 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.
