Recalls and Other Corrective Action Sample Clauses

Recalls and Other Corrective Action. Valera shall have the right and responsibility to conduct, at its own expense, any recall, market withdrawals, or other corrective action related to Product in the Territory. At the reasonable request of Valera, Indevus will assist Valera in conducting such recall, provided that any and all fully-burdened costs incurred by Indevus shall be reimbursed by Valera. This Section applies only to the extent that such recalls, withdrawals or corrective actions were caused by some action or omission of Valera.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Recalls and Other Corrective Action. The Development Committee shall make all final decisions with respect to any recall, market withdrawal or any other corrective action related to a Product in the Field in the Territory, and neither Party shall initiate any such action without the approval of the Development Committee; provided, however, that nothing herein shall prohibit Indevus, prior to the NDA Transfer Date, from initiating or conducting any recall or other corrective action mandated by the FDA or Law. At a Party’s request, the other Party shall provide reasonable assistance in conducting such recall, market withdrawal or other corrective action, including providing all pertinent records that such Party may reasonably request to assist in effecting such action, subject to reimbursement of such other Party’s reasonable costs and expenses associated with providing such cooperation. Any documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to such recall, market withdrawal or other corrective action prior to the Processing Assumption Date shall be borne by Indevus; provided, however, that, in the event that the recall or other corrective action is attributable solely to Promotional activities under Article 5, Esprit shall bear such expenses. Any documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to a recall, market withdrawal or other corrective action with respect to Products in the Field in the Territory after the Processing Assumption Date shall be borne by Esprit. Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages, lost profits or income that may arise in connection with any recall, market withdrawal or corrective action with respect to Products.
Sample 1Sample 2
Recalls and Other Corrective Action. If any Regulatory Authority in the Territory issues or requests a recall, market withdrawal or other corrective action (a “Recall”) of the Licensed Product, or if either Party determines that an event, incident or circumstance has occurred that may indicate the need for a Recall in the Territory, the Party notified of such Recall, or the Party that desires such Recall, will advise the other Party thereof by telephone or fax within twenty-four (24) hours of (i) its receipt of notice from a Regulatory Authority requiring or requesting a Recall or (ii) such Party’s determination that a Recall is indicated, and the Development Committee shall convene a joint telephonic meeting to discuss such Recall request within twenty-four (24) hours of such notification. Before the NDA Transfer Date, Titan shall make all decisions with respect to any Recall related to a Product in the Territory. After the NDA Transfer Date, Braeburn shall make all decisions with respect to any Recall related to a Product in the Territory. After the NDA Transfer Date, at Braeburn’s request, Titan shall provide reasonable assistance in conducting any such Recall, including providing all pertinent records that Braeburn may reasonably request to assist in effecting such action, subject to reimbursement of Titan’s Fully Burdened Costs associated with providing such cooperation, and any other documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to such Recall shall be borne by Braeburn. Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages, lost profits or income that may arise in connection with any Recall with respect to Products.
Sample 1Sample 2
Recalls and Other Corrective Action. If any Regulatory Authority in the Territory issues or requests a recall, market withdrawal or other corrective action (a “Recall”) of the Licensed Product, or if either Party determines that an event, incident or circumstance has occurred that may indicate the need for a Recall in the Territory, the Party notified of such Recall, or the Party that desires such Recall, will advise the other Party thereof by telephone or fax within twenty-four (24) hours of (i) its receipt of notice from a Regulatory Authority requiring or requesting a Recall or (ii) such Party’s determination that a Recall is indicated, and the Development Committee shall convene a joint telephonic meeting to discuss such Recall request within twenty-four (24) hours of such notification. Before the NDA Transfer Date, Titan shall make all decisions with respect to any Recall related to a Product in the Territory. After the NDA Transfer Date, Braeburn shall make all decisions with respect to any Recall related to a Product in the Territory. After the NDA Transfer Date, at Braeburn’s request, Titan shall provide reasonable assistance in conducting any such Recall, including providing all pertinent records that Braeburn may reasonably request to assist in effecting such action, subject to reimbursement of Titan’s Fully Burdened Costs associated with providing such cooperation, and any other documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to such Recall shall be borne by Braeburn. Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. damages, lost profits or income that may arise in connection with any Recall with respect to Products.
Sample 1Sample 2
Recalls and Other Corrective Action. CRTX shall have the sole right and responsibility to conduct, [**] any recall, market withdrawals, or other corrective action related to Product in the Territory. At CRTX's [**], Xxx shall provide information, as needed by CRTX to conduct such recall, market withdrawals, or other corrective action related to Product in the Territory.
Sample 1
Recalls and Other Corrective Action. The Steering Committee shall make all final decisions with respect to any recall, market withdrawal or any other corrective action related to Product in the United States, and neither Party shall initiate any such action without the approval of the Steering Committee; provided, however, that nothing herein shall prohibit Indevus, as the NDA holder, from initiating or conducting any recall or other corrective action mandated by the FDA or applicable Law. Subject to the foregoing sentence, Indevus shall have the first right to conduct any recall, market withdrawals, or other corrective action related to Product in the United States. At a Party’s request, the other shall provide reasonable assistance in conducting such recall, market withdrawal or other corrective action, including, without limitation, providing all pertinent records that the other Party may reasonably request to assist in effecting such action. Any documented, direct, out-of-pocket costs incurred (paid or accrued) by Indevus with respect to such recall or other corrective action shall be deemed Indevus Product Expenses; provided, however, that in the event that the recall or other corrective action is attributable solely to Promotional activities, it should be deemed an Odyssey Product Expense. Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages, lost profits or income that may arise in connection with any recall, market withdrawal or corrective action with respect to Product.
Sample 1
Recalls and Other Corrective Action. Teva shall make all final decisions with respect to any recall, market withdrawal or any other corrective action related to Product, and nothing herein shall prohibit Teva from initiating or conducting any recall or other corrective action mandated by a Regulatory Authority or applicable Law. Teva shall conduct any recall, market withdrawals, or other corrective action related to Product. At Teva’s request, during the U.S. Collaboration Period, Indevus shall provide reasonable assistance in conducting such recall, market withdrawal or other corrective action, including providing all pertinent records that Teva may reasonably request to assist in effecting such action. With respect to any recall, market withdrawal or any corrective action related to Product that occurs during the U.S. Collaboration Period and that arises from a defect in the design of the Compound or Product, the Parties agree that they will share equally all documented, direct, out-of-pocket costs and expenses incurred in connection with such recall, market withdrawal or corrective action. With respect to any such recall, market withdrawal or any corrective action related to Product that occurs during the U.S. License Period, or any recall, market withdrawal or any corrective action related to Product at any time that arises from a failure of the Product to meet specifications required by an applicable Regulatory Authority, as between Teva and Indevus, Teva shall be responsible for all direct costs and expenses associated with such recall, market withdrawal or corrective action; provided, however, that if such recall, market withdrawal or corrective action occurs during the U.S. Collaboration Period and is caused by a Product defect or failure to conform to applicable specifications attributable to manufacturing by a Third Party, and Teva, notwithstanding its compliance with pharmaceutical manufacturing industry-appropriate quality assurance and quality control practices and testing standards, failed to detect such Product defect or failure to conform to applicable specifications, then the Parties agree that they will share equally all documented, direct out-of-pocket costs and expenses incurred in connection with such recall, market withdrawal or corrective action. In case of a dispute between the Parties as to whether Teva complied with such industry-appropriate quality assurance and quality control practices and testing standards, the Parties agree to submit any such dispute to a mutual...
Sample 1
AutoNDA by SimpleDocs
Recalls and Other Corrective Action. Molteni shall make all decisions with respect to any recall, market withdrawal or other corrective action (“Recall”) related to a Final Product in the Territory. At Molteni’s request, Titan shall provide reasonable assistance in conducting any such Recall, including providing all pertinent records that Molteni may reasonably request to assist in effecting such action, subject to reimbursement of Titan’s Fully Burdened Costs associated with providing such cooperation, and any other documented, direct, out-of-pocket costs incurred (paid or accrued) by Titan with respect to such Recall shall be borne by Molteni. If any Regulatory Authority in the Territory issues or requests a Recall of the Final Product, or if either Party determines that an event, incident or circumstance has occurred that may indicate the need for a Recall in the Territory, the Party notified of such Recall, or the Party that desires such Recall, will advise the other Party thereof by telephone or fax within twenty-four (24) hours of (i) its receipt of notice from a Regulatory Authority requiring or requesting a Recall or (ii) such Party’s determination that a Recall is indicated, and, without limiting Molteni’s rights to make all decisions with respect to such Recall in the Territory in the first sentence of this Section 4.2(e), the Steering Committee shall convene a joint telephonic meeting to discuss such Recall request within twenty-four (24) hours of such notification.
Sample 1
Recalls and Other Corrective Action 
Sample 1Sample 2

Related to Recalls and Other Corrective Action

  • 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:

  • 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.

  • 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 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.

  • 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

  • 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.

  • Legal and Other Compliance The Company at its own expense, will use its best efforts to obtain any registration, qualification or approval required to sell any Securities under the laws (including U.S. state “blue sky” laws relating to broker registration and the making of notice filings) of any applicable jurisdictions (including any applicable foreign jurisdiction or any instrumentality thereof). Without limiting the generality of the foregoing, the Company represents that it is not subject to any disqualifying event as set forth in Rule 262 under the Securities Act. The Company agrees that it is responsible for compliance with the restrictions on investment amounts set out in Reg A+. The Company understands and agrees that there are compliance requirements that pertain to the Offering both on the Platform and off the Platform. The Company further understands and agrees that StartEngine does not purport to make any representation, warranty, or guarantee that any activity by the Company or StartEngine, whether through the Platform or not, is in compliance with applicable state or Federal securities laws or the rules and regulations of any self-regulatory organization. It is expressly understood that none of the services provided by StartEngine should be deemed legal advice. StartEngine makes no representation or warranties that offerings of securities on the Platform comply with state or Federal securities laws. The Company agrees that it shall consult its legal counsel to independently determine whether use of the Platform for the Offering complies with state and Federal laws, rules and regulations.

  • 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

  • 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.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!