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.
Sample 1Sample 2
AutoNDA by SimpleDocs
Certain Corrective Actions. 17 8.6 Disclosure by Fresenius Parties................................. 17 ARTICLE 9 INTELLECTUAL PROPERTY FILINGS, PROSECUTION, REGISTRATION AND MAINTENANCE
Sample 1Sample 2
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.
Sample 1
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.
Sample 1
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.
Sample 1

Related to Certain Corrective Actions

  • 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 The NAVITAIRE Account Manager shall monitor corrective action and report to the Executive Sponsors. In the event that Minimum System Availability Targets are not met during the Reporting Period, the NAVITAIRE Account Manager shall initiate corrective action during the subsequent Reporting Period. NAVITAIRE shall, at its own expense, use commercially reasonable efforts to correct the deficiency in order to meet future Minimum System Availability Targets.

  • 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.

  • Adverse Actions Take any action or fail to take any action that is intended or is reasonably likely to result in (i) any of its representations and warranties set forth in this Agreement being or becoming untrue in any material respect at any time at or prior to the Effective Time, (ii) any of the conditions to the Merger set forth in Article VI not being satisfied or (iii) a material violation of any provision of this Agreement, except, in each case, as may be required by applicable law or regulation.

  • Certain ERISA Matters (a) Each Lender (x) represents and warrants, as of the date such Person became a Lender party hereto, to, and (y) covenants, from the date such Person became a Lender party hereto to the date such Person ceases being a Lender party hereto, for the benefit of, the Administrative Agent and not, for the avoidance of doubt, to or for the benefit of the Borrower or any other Loan Party, that at least one of the following is and will be true:

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Investigations; Litigation There is no investigation or review pending (or, to the knowledge of Parent, threatened) by any Governmental Entity with respect to Parent or any of its Subsidiaries which would have, individually or in the aggregate, a Parent Material Adverse Effect, and there are no actions, suits, inquiries, investigations or proceedings pending (or, to Parent’s knowledge, threatened) against or affecting Parent or its Subsidiaries, or any of their respective properties at law or in equity before, and there are no orders, judgments or decrees of, or before, any Governmental Entity, in each case which would have, individually or in the aggregate, a Parent Material Adverse Effect.

  • Certain Environmental Matters (i) The Company and its subsidiaries (x) are in compliance with all, and have not violated any, applicable federal, state, local and foreign laws (including common law), rules, regulations, requirements, decisions, judgments, decrees, orders and other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”); (y) have received and are in compliance with all, and have not violated any, permits, licenses, certificates or other authorizations or approvals required of them under any Environmental Laws to conduct their respective businesses; and (z) have not received notice of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice, and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiaries, except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) except as described in each of the Pricing Disclosure Package and the Prospectus, (x) there is no proceeding that is pending, or that is known to be contemplated, against the Company or any of its subsidiaries under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiaries are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that could reasonably be expected to have a material effect on the capital expenditures, earnings or competitive position of the Company and its subsidiaries, and (z) none of the Company or its subsidiaries anticipates material capital expenditures relating to any Environmental Laws.

  • California Accessibility Disclosure For purposes of Section 1938(a) of the California Civil Code, Landlord hereby discloses to Tenant, and Tenant hereby acknowledges, that the Project has not undergone inspection by a Certified Access Specialist (CASp). In addition, the following notice is hereby provided pursuant to Section 1938(e) of the California Civil Code: “A Certified Access Specialist (CASp) can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the subject premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the premises.” In furtherance of and in connection with such notice: (i) Tenant, having read such notice and understanding Tenant’s right to request and obtain a CASp inspection, hereby elects not to obtain such CASp inspection and forever waives its rights to obtain a CASp inspection with respect to the Premises, Building and/or Project to the extent permitted by Legal Requirements; and (ii) if the waiver set forth in clause (i) hereinabove is not enforceable pursuant to Legal Requirements, then Landlord and Tenant hereby agree as follows (which constitutes the mutual agreement of the parties as to the matters described in the last sentence of the foregoing notice): (A) Tenant shall have the one-time right to request for and obtain a CASp inspection, which request must be made, if at all, in a written notice delivered by Tenant to Landlord; (B) any CASp inspection timely requested by Tenant shall be conducted (1) at a time mutually agreed to by Landlord and Tenant, (2) in a professional manner by a CASp designated by Landlord and without any testing that would damage the Premises, Building or Project in any way, and (3) at Tenant’s sole cost and expense, including, without limitation, Tenant’s payment of the fee for such CASp inspection, the fee for any reports prepared by the CASp in connection with such CASp inspection (collectively, the “CASp Reports”) and all other costs and expenses in connection therewith; (C) the CASp Reports shall be delivered by the CASp simultaneously to Landlord and Tenant; (D) Tenant, at its sole cost and expense, shall be responsible for making any improvements, alterations, modifications and/or repairs to or within the Premises to correct violations of construction-related accessibility standards including, without limitation, any violations disclosed by such CASp inspection; and (E) if such CASp inspection identifies any improvements, alterations, modifications and/or repairs necessary to correct violations of construction-related accessibility standards relating to those items of the Building and Project located outside the Premises that are Landlord’s obligation to repair as set forth in this Lease, then Landlord shall perform such improvements, alterations, modifications and/or repairs as and to the extent required by Legal Requirements to correct such violations, and Tenant shall reimburse Landlord for the cost of such improvements, alterations, modifications and/or repairs within 10 business days after Tenant’s receipt of an invoice therefor from Landlord.

  • Environmental and Safety Matters Except as disclosed in Schedule 4.13:

Time is Money Join Law Insider Premium to draft better contracts faster.