Certain Corrective Actions Sample Clauses

Certain Corrective Actions. In the event that the FDA, or any Territorial Regulator having jurisdiction shall order any change or corrective action, including a recall, with respect to the Product as then being manufactured, sold or distributed by the Fresenius Parties or if, notwithstanding that any such change or corrective action shall not have been ordered, the Fresenius Parties acting reasonably and in good faith believe, based on appropriate expert evidence or advice, that absent such change or corrective action one or both of them will be in violation of a rule of law or other regulatory requirement applicable to it as the manufacturer or distributor of the Product, the Fresenius Parties shall have sole authority to determine the nature and extent of its compliance with such order or any action, including a recall, to be taken notwithstanding the absence of any such order, as the case may be; provided, that any such order relating to the safety or integrity of the Product shall be resolved to the satisfaction of the regulatory authority issuing such order.
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Certain Corrective Actions. 17 8.6 Disclosure by Fresenius Parties................................. 17 ARTICLE 9 INTELLECTUAL PROPERTY FILINGS, PROSECUTION, REGISTRATION AND MAINTENANCE
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Certain Corrective Actions. In the event that any regulatory body having jurisdiction in the Territory shall order any change or corrective action, including a recall, with respect to any of the Products or if, notwithstanding that any such change or corrective action shall not have been ordered, Hema, acting reasonably and in good faith believes, based on appropriate expert evidence or advice, that absent such change or corrective action it will be in violation of a rule of law or other regulatory requirement in any of the Territory applicable to it as distributor of any of the Products, then Hema, as the responsible product manufacturer with respect to such Products in the applicable Territory, shall consult with ProMetic to determine the nature and extent of its compliance with such order or any action, including a recall, to be taken notwithstanding the absence of any such order, as the case may be, provided that any such order relating to the safety or integrity of the Products shall be resolved to the satisfaction of the regulatory authority issuing such order. Hema shall advise ProMetic as promptly as practicable of the issuance of any such order against it and agree that ProMetic will take any active role in responding to such order or in the corrective order to be taken. The Parties agree to collaborate in good faith to find an acceptable corrective action or appropriate response.
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Certain Corrective Actions. In the event that any Regulatory Body having jurisdiction in the Territory shall order any change or corrective action, including a recall, with respect to any of the Proteins, Additional Proteins or Products then being manufactured, sold or distributed by the Licensee or if, notwithstanding that any such change or corrective action shall not have been ordered, the Licensee acting reasonably and in good faith believes, based on appropriate expert evidence or advice, that absent such change or corrective action it will be in violation of a rule of law or other regulatory requirement in any of the Territory applicable to it as the manufacturer or distributor of any of the Proteins, Additional Proteins and Products, then the Licensee, as the responsible product manufacturer with respect to such Proteins, Additional Proteins and Products in the applicable Territory, shall have sole authority to determine the nature and extent of its compliance with such order or any action, including a recall, to be taken notwithstanding the absence of any such order, as the case may be, provided that any such order relating to the safety or integrity of the Proteins, Additional Proteins and Products shall be resolved to the satisfaction of the regulatory authority issuing such order. Without limiting the generality of the foregoing, before responding to any such order or taking any such action, the Licensee shall consult with the Licensor with respect to any such order, its compliance therewith, or any action to be taken with respect to such order, and the Licensee shall advise the Licensor as promptly as practicable of the issuance of any such order against it and of the steps being taken to resolve the matter or the taking of such action. Should the Licensor reasonably consider that the Licensee's actions taken with respect to any order received from the Regulatory Body is not appropriate and does not adequately protect the reputation of the Cascade Process or the Licensor, or the effectiveness or quality of the Cascade Process, the Licensor may take an active role in responding to such order or in the corrective order to be taken, the whole at its own cost. The parties agree to collaborate in good faith to find an acceptable corrective action or appropriate response should the Licensor take such an active role.
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Certain Corrective Actions. In the event that any Regulatory Body having jurisdiction in the Territory shall order any change or corrective action, including a recall, with respect to any of the [***]Product then being manufactured, sold or distributed by the Licensee or if, notwithstanding that any such change or corrective action shall not have been ordered, the Licensee acting reasonably and in good faith believes, based on appropriate expert evidence or advice, that absent such change or corrective action it will be in violation of a rule of law or other regulatory requirement in any of the Territory applicable to it as the manufacturer or distributor of any of the [***]Product, then the Licensee, as the responsible product manufacturer with respect to such [***]Product in the applicable Territory, shall consult with Licensor to determine the nature and extent of its compliance with such order or any action, including a recall, to be taken notwithstanding the absence of any such order, as the case may be, provided that any such order relating to the safety or integrity of the [***]Product shall be resolved to the satisfaction of the regulatory authority issuing such order. The Licensee shall advise the Licensor as promptly as practicable of the issuance of any such order against it and agree that Licensor will take an active role in responding to such order or in the corrective order to be taken. The Parties agree to collaborate in good faith to find an acceptable corrective action or appropriate response.
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Related to Certain Corrective Actions

  • Corrective Actions The Government will use its best efforts to ensure that each Covered Provider (i) takes, where necessary, appropriate and timely corrective actions in response to audits, (ii) considers whether the results of the Covered Provider’s audit necessitates adjustment of the Government’s records, and (iii) permits independent auditors to have access to its records and financial statements as necessary.

  • Mitigation and Corrective Action Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to it of an impermissible use or disclosure of PHI, even if the impermissible use or disclosure does not constitute a Breach. Business Associate shall draft and carry out a plan of corrective action to address any incident of impermissible use or disclosure of PHI. If requested by Covered Entity, Business Associate shall make its mitigation and corrective action plans available to Covered Entity. Business Associate shall require a Subcontractor to agree to these same terms and conditions.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Corrective Action Despite its right to terminate this Agreement pursuant to this Article, the LHIN may choose not to terminate this Agreement and may take whatever corrective action it considers necessary and appropriate, including suspending Funding for such period as the LHIN determines, to ensure the successful completion of the Services in accordance with the terms of this Agreement.

  • Corrective Action Plan Within fifteen (15) Business Days following the establishment of the Joint Remediation Committee, the Purchasers, in consultation with the Sellers, shall prepare and submit to the Joint Remediation Committee an initial draft of the Corrective Action Plan. The parties shall work in good faith through the Joint Remediation Committee to finalize the Corrective Action Plan within fifteen (15) Business Days of the Purchasers’ submission of the initial draft of the Correct Action Plan. At the end of such period, if the Sellers reasonably determine that the Corrective Action Plan proposed by the Purchasers (as may be modified over the course of such period) would not reasonably be expected to satisfactorily address the Major Default, then the Sellers may escalate the issue to the Head of Commercial Capital (or equivalent leader of any successor business unit) of the Seller Group and the Chief Executive Officer of the Bank Assets Purchaser (the “Senior Executives”) and the Senior Executives shall work collaboratively (including with the Joint Remediation Committee) to develop a mutually agreeable Corrective Action Plan within fifteen (15) Business Days.

  • Corrective Action Plans If the OAG finds deficiencies in XXXXXXX’s performance under this Grant Contract, the OAG, at its sole discretion, may impose one or more of the following remedies as part of a corrective action plan: increase of monitoring visits; require additional or more detailed financial and/or programmatic reports be submitted; require prior approval for expenditures; require additional technical or management assistance and/or make modifications in business practices; reduce the contract amount; and/or terminate this Grant Contract. The foregoing are not exclusive remedies, and the OAG may impose other requirements that the OAG determines will be in the best interest of the State.

  • Proposed Corrective Action Plan Simultaneously with the submission of the Audit, the Recipient will submit to OCR for its review and approval a proposed Corrective Action Plan to address all inaccessible content and functionality identified during the Recipient’s Audit. The proposed Corrective Action Plan will set out a detailed schedule for: (1) addressing problems, taking into account identified priorities, with all corrective actions to be completed within 18 months of the date OCR approved the Corrective Action Plan; (2) setting up systems of accountability and verifying claims of accessibility by vendors or open sources; and setting up a system of testing and accountability to maintain the accessibility of all online content and functionality on an ongoing basis.

  • Proposal of Corrective Action Plan In addition to the processes set forth in the Contract (e.g., service level agreements), if the Department or Customer determines that there is a performance deficiency that requires correction by the Contractor, then the Department or Customer will notify the Contractor. The correction must be made within a time-frame specified by the Department or Customer. The Contractor must provide the Department or Customer with a corrective action plan describing how the Contractor will address all performance deficiencies identified by the Department or Customer.

  • Affirmative Action Compliance The offeror represents that- (i) It □ has developed and has on file, □ has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or (ii) It □ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

  • Affirmative Action Plan 1 CONSULTANT shall certify that if it has fifty (50) or more employees, a written affirmative action plan has been filed or will be developed and submitted (within 120 days of contract award) for each establishment. File current Affirmative Action plans, if required, with one of the following: The Office of Federal Contract Compliance Programs, the State of Wisconsin, or the Milwaukee County Department of Audit, 000 X. Xxxxxxxxx Xxxxxx, 0xx Xxxxx, Xxxxxxxxx, Xxxxxxxxx 00000. If a current plan has been filed, indicate where filed and the year covered

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