Recalls and Other Corrective Actions Clause Samples

Recalls and Other Corrective Actions. The Parties shall advise each other as soon as reasonably practicable but whenever possible no later than forty-eight (48) hours in advance of any planned recall, market withdrawals, or other corrective action related to Product intended to be conducted by either Party or any of its Affiliates that implicates Product supplied by Schering to Indevus and shall keep each other informed with respect to the status of any such actions. Unless regulated otherwise herein, Indevus shall have responsibility for and shall make all decisions relating to conducting any recall, market withdrawals, or other corrective action related to Product in the Territory. The Parties shall consult with each other with respect thereto and Indevus shall consider in good faith any comments or suggestions of Schering, provided, however, that nothing herein shall prohibit Indevus, from initiating or conducting any recall or other corrective action mandated by the FDA or applicable law. At Indevus’ request, Schering shall provide reasonable assistance in conducting such recall, market withdrawal or other corrective action, including, without limitation, providing all pertinent records that Indevus may reasonably request to assist in effecting such action. Indevus shall bear any and all costs of any such recall, market withdrawal or other corrective action with respect to Product in the Territory, except that Schering shall bear any and all such costs if such recall, market withdrawal or other corrective action is attributable predominantly to the fault of Schering or results from a negligent or reckless act or omission or intentional misconduct on the part of Schering or its Affiliates or the failure of Substance or Product to be manufactured or shipped by Schering or its Affiliates in compliance with all applicable laws, rules and regulations, and the Specifications or any breach by Schering of applicable laws, rules or regulations, or the provisions of this Agreement.

Recalls and Other Corrective Actions. If a Party believes that a recall or market withdrawal of a Product in the Territory may be required, then such Party will so notify the other Party within [***], and, without limitation of and subject to this Section 7.8 (Recalls and Other Corrective Actions), the Parties will decide whether or not such a recall or market withdrawal is required. Decisions with respect to any recall, market withdrawal, or other corrective action related to any Product in the Kiniksa Field in the Territory will be made [***]; provided, however, that if the [***] will have such final decision authority on and after the U.S. Marketing Approval (the Party responsible for recalls or market withdrawals pursuant to this Section 7.8 (Recalls and Other Corrective Actions), the “Recall Responsible Party”). Notwithstanding the foregoing (including a Party’s final decision making authority), nothing herein will prohibit either Party from initiating or conducting any recall or other corrective action mandated by any Governmental Authority or Applicable Law. If the non-Recall Responsible Party wishes to initiate a recall or market withdrawal of a Product in the Territory in good faith, but the Parties are unable to agree on whether or not to initiate any such recall or other action, and thereafter the Recall Responsible Party does not initiate a recall or market withdrawal of a Product in the Territory, then [***]. The Parties will cooperate with respect to any actions taken or public statements made in connection with any such recall or market withdrawal. Any recall of any Product in the Territory caused by [***]. Any recall caused by [***]. Any recall of the Product in the Kiniksa Field in the Territory not [***].

Recalls and Other Corrective Actions. 16.1 In the event BIO HOSPITAL believes a recall, field alert, Product withdrawal or field correction (any of the foregoing, a “Recall”) may be necessary with respect to any Product, BIO HOSPITAL shall immediately contact OCEANA to discuss their belief. BIO HOSPITAL shall not act to initiate a Recall without the express prior written approval of OCEANA, unless otherwise required by Applicable Laws. In the event OCEANA believes a Recall may be necessary with respect to any Product, OCEANA shall immediately notify BIO HOSPITAL to discuss its belief and BIO HOSPITAL shall provide all necessary cooperation and assistance to OCEANA. Unless otherwise set forth herein, OCEANA shall have responsibility for and shall make all decisions relating to conducting any Recall related to Product in the Territory. INVDEVUS shall notify BIO HOSPITAL of the decision to initiate a regulatory action prior to notification to the regulatory agency whenever possible.

Recalls and Other Corrective Actions. Prior to the Regulatory Transfer Date, decisions with respect to any recall, market withdrawal, or other corrective action related to such Product for use in the Field in the Territory (each, a “Recall”) shall be made by TBIL, in consultation with the JSC, and all expenses of such Recall shall be the responsibility of TBIL. In the event that Takeda believes that a Recall of a particular Product may be required prior to the Regulatory Transfer Date, Takeda shall promptly notify TBIL and TBIL shall take such notice into consideration and decide whether such Recall is required. After the Regulatory Transfer Date, decisions with respect to any Recall of such Product shall be made by Takeda, at its sole discretion, and all expenses of such Recall shall be the responsibility of Takeda. In the event that TBIL believes that a Recall may be required, TBIL shall promptly notify Takeda and Takeda shall take such notice into consideration and decide whether such Recall is required. Prior to the Regulatory Transfer Date, the Parties shall jointly determine, and after the Regulatory Transfer Date, Takeda shall determine in its sole discretion, acting reasonably and in good faith and without inappropriately denigrating the Product or the Parties, any actions taken or public statements made in connection with any Recall of such Product and TBIL shall, upon Takeda’s reasonable written request, cooperate in such actions.

Recalls and Other Corrective Actions. (a) Decisions with respect to any recall, market withdrawal or other corrective action related to any Product shall be made by the Company, unless such decision making is transferred to a Third Party. If a decision with respect to any recall, market withdrawal or other corrective action related to any Product is made by the Company, the Company shall provide to Arbutus prompt written notice if the Company determines to conduct any recall, market withdrawal or other corrective action in respect of a Product. The Parties shall cooperate in good faith with respect to any actions taken or public statements made in connection with any such recall or market withdrawal. (b) Decisions with respect to any recall, market withdrawal or other corrective action related to any Arbutus Licensed Product shall be made by Arbutus, unless such decision making is transferred to a Third Party. If a decision with respect to any recall, market withdrawal or other corrective action related to any Product is made by Arbutus, Arbutus shall provide to the Company prompt written notice if Arbutus determines to conduct any recall, market withdrawal or other corrective action in respect of an Arbutus Licensed Product. The Parties shall cooperate in good faith with respect to any actions taken or public statements made in connection with any such recall or market withdrawal.

Recalls and Other Corrective Actions. 1. If Marvel or Co-Promotion Partner reasonably concludes from information supplied by any source that a defect or failure to comply as described in Section C (Notices of Product Claims) above exists, then Co-Promotion Partner shall at its expense take such action as is required by Laws, including without limitation, notifying the appropriate Regulatory Agency in the country in which the Merchandise is being sold or distributed to consumers. Co-Promotion Partner shall take such actions as the Regulatory Agency shall require, including without limitation, (a) notifying the public of such failure or defect, (b) retrieving, recalling or withdrawing the Merchandise from Authorized Customers, (c) destroying, repairing and/or replacing the Merchandise, and (d) refunding sums paid and expenses incurred by consumers and others by reason of the recall. Co-Promotion Partner shall promptly provide Marvel with information regarding the foregoing, including without limitation, contemporaneous copies of correspondence, reports or other communications with the Regulatory Agency. In the event the applicable Law does not require Co- Promotion Partner to notify the Regulatory Agency or, in the event notification has taken place but there is no direction given by the Regulatory Agency, Co-Promotion Partner shall discuss in good faith with Marvel the steps to be taken and shall at Co-Promotion Partner’s expense take such steps as Marvel, in its reasonable discretion, shall direct. Marvel reserves the right to notify the Regulatory Agency about the Merchandise at issue in the event that Co-Promotion Partner does not do so and Marvel deems it prudent to do so. Whether Marvel or Co-Promotion Partner notifies a Regulatory Agency that a defect or failure to comply exists, all reasonable expenses paid or incurred by Marvel by reason of or in connection with such notification, including without limitation, all expenses in connection with a recall, shall be promptly reimbursed by Co-Promotion Partner to Marvel. 2. Co-Promotion Partner shall provide Marvel with all proposed public notices or statements of any kind regarding a failure, defect, withdrawal or recall of any Merchandise (including without limitation, press releases, posters, tweets, texts, and/or social media postings) for Marvel’s review and written approval prior to issuance. The obligations of Co-Promotion Partner under these Sections A through D are in addition to and not in limitation of other obligations, representat...

Recalls and Other Corrective Actions