Recalls and Other Corrective Actions Sample Clauses

Recalls and Other Corrective Actions. Decisions with respect to any recall, market withdrawal or other corrective action related to any Licensed Product in the Field in the Territory shall be made only upon mutual agreement of the Parties, which agreement shall not be unreasonably withheld or delayed; provided, however, that nothing herein shall prohibit either Party from initiating or conducting any recall or other corrective action mandated by a Governmental Authority or Law. The Party that determines that a recall or market withdrawal of a Licensed Product in the Field in the Territory may be required shall, within twenty-four (24) hours, notify the other Party and, without limitation of and subject to the proviso in the immediately preceding sentence, the Parties shall decide whether such a recall or market withdrawal is required. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such recall or market withdrawal. Expenses associated with such recalls will be treated as Other Shared Expenses.
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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.
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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, Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd. 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 [***].
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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.
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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.
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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.
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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.
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Recalls and Other Corrective Actions 
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Related to Recalls and Other Corrective Actions

  • Corrective and Other Allocations In the event of any allocation of Additional Book Basis Derivative Items or any Book-Down Event or any recognition of a Net Termination Loss, the following rules shall apply:

  • Employees, ERISA and Other Compliance 2.15.1 Neither the Company nor any subsidiary of the Company has any employment contract or consulting agreement currently in effect that is not terminable at will (other than agreements with the sole purpose of providing for the confidentiality of proprietary information or assignment of inventions) without liability to the Company or such subsidiary. All officers, directors, employees and consultants of the Company having access to proprietary information have executed and delivered to the Company an agreement regarding the protection of such proprietary information and the assignment of inventions to the Company; true and complete copies of the form of all such agreements have been delivered to DoveBid.

  • Regulatory and Other Matters (a) The parties shall, and shall cause their respective Subsidiaries to, cooperate with each other and use their respective commercially reasonable efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings with any Third Party or Governmental Entity and to take any further actions reasonably requested by the other party to obtain as promptly as practicable the Required Approvals and other consents required to be obtained in connection with the Merger and the other transactions contemplated by this Agreement. MCC and SIC shall have the right to review in advance, and, to the extent practicable, each will consult with the other on, in each case subject to Applicable Laws relating to the confidentiality of information, all information relating to MCC or SIC, as the case may be, and any of their respective Subsidiaries, that appear in any filing made with, or written materials submitted to, any Third Party or any Governmental Entity in connection with obtaining the Required Approvals. In exercising the foregoing right, each of the parties shall act reasonably and as promptly as reasonably practicable. The parties shall consult with each other with respect to the obtaining of the Required Approvals and each party will keep the other apprised of the status of matters relating to completion of the transactions contemplated by this Agreement. 45

  • Regulatory and Other Approvals Seller will (a) proceed diligently and in good faith and use its best efforts, as promptly as practicable, to obtain all consents, approvals or actions of, to make all filings with and to give all notices to Governmental Authorities or any other Person required of Seller, including without limitation any consents required with respect to Seller’s interests in Assumed Contracts, to consummate the transactions contemplated hereby and by the Related Agreements, (b) provide such other information and communications to such Governmental Authorities or other Persons as Buyer or such Governmental Authorities or other Persons may reasonably request in connection therewith and (c) cooperate with Buyer as promptly as practicable in obtaining all consents, approvals or actions of, making all filings with and giving all notices to Governmental Authorities or other Persons required of Buyer to consummate the transactions contemplated hereby and by the Related Agreements. Seller will provide prompt notification to Buyer when any such consent, approval, action, filing or notice referred to in clause (a) above is obtained, taken, made or given, as applicable, and will advise Buyer of any communications (and, unless precluded by Law, provide copies of any such communications that are in writing) with any Governmental Authority or other Person regarding any of the transactions contemplated by this Agreement or any of the Related Agreements. Seller knows of no reason relating to Seller why the approvals, consents or waivers of governmental authorities required to complete the transactions contemplated hereby will not be obtained in a timely manner.

  • Environmental and Other Laws Except as disclosed in Section 5.11 of the Disclosure Schedule: (a) Restricted Persons are conducting their businesses in material compliance with all applicable Laws, including Environmental Laws, and have, and are in material compliance with, all licenses and permits required under any such Laws; (b) to the best of Borrower’s knowledge, none of the operations or properties of any Restricted Person is the subject of federal, state or local investigation evaluating whether any material remedial action is needed to respond to a release of any Hazardous Materials into the environment or to the improper storage or disposal (including storage or disposal at offsite locations) of any Hazardous Materials; (c) no Restricted Person (and to the best knowledge of Borrower, no other Person) has filed any notice under any Law indicating that any Restricted Person is responsible for the improper release into the environment, or the improper storage or disposal, of any material amount of any Hazardous Materials or that any material amount of any Hazardous Materials have been improperly released, or are improperly stored or disposed of, upon any property of any Restricted Person; (d) no Restricted Person has transported or arranged for the transportation of any Hazardous Material to any location that is (i) listed on the National Priorities List under the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, listed for possible inclusion on such National Priorities List by the Environmental Protection Agency in its Comprehensive Environmental Response, Compensation and Liability Information System List, or listed on any similar state list or (ii) the subject of federal, state or local enforcement actions or other investigations that may lead to material claims against any Restricted Person for clean-up costs, remedial work, damages to natural resources or for personal injury claims (whether under Environmental Laws or otherwise); and (e) no Restricted Person otherwise has any known material contingent liability under any Environmental Laws or in connection with the release into the environment, or the storage or disposal, of any Hazardous Materials.

  • Regulatory and Other Authorizations Each party hereto shall use its commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of any Governmental Authority that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals.

  • Organizational and Other Matters Section 2.01 The Company was formed as a limited liability company under the provisions of the Act by the filing of the Certificate with the Secretary of State of the State of Delaware on the date concurrent with the date of this Agreement. The rights and liabilities of the Sole Member shall be as provided in the Act, except as otherwise expressly provided herein. F:\USERS\jenglish\Office\ENSCO Corporate Resources LLC\LLC Agreement.12.09

  • Utilities and Other Services 4.4.1 The Tenant shall arrange, at its own cost and expense, for the installation, connection and supply of all utilities and any other services required by it at or in relation to the Premises.

  • Returns and Other Elections The Managers shall cause the preparation and timely filing of all tax returns required to be filed by the Company pursuant to the Code and all other tax returns deemed necessary and required in each jurisdiction in which the Company does business. Copies of such returns, or pertinent information therefrom, shall be furnished to the Member within seventy-five (75) days after the end of each Fiscal Year of the Company. All elections permitted to be made by the Company under federal or state laws shall be made by the Managers with the consent of the Member.

  • Regulatory and Other Notices Promptly after Borrower’s receipt thereof, copies of any notices or other communications received from any Governmental Authority with respect to any matter or proceeding the effect of which could reasonably be expected to have a Material Adverse Effect.

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