Actions taken for Safety Reasons Sample Clauses

Actions taken for Safety Reasons. The Parties shall promptly exchange information on regulatory actions, pending actions that might result in a labelling change, health authority inquiries for safety and/or efficacy reason(s), which may significantly affect safety profile or benefit/risk balance of the Subject Product or market restriction due to issues including but not limited to: • Marketing Authorisation withdrawal or suspension; • failure to obtain a Marketing Authorisation renewal, restrictions on distribution; • clinical trial suspension, or protocol amendment; • health providers and/or Public Communications; • dosage modification; • changes in target population or indications, formulation changes; or • modification of the investigator brochure and/or core safety data sheet and/or labelling, etc. Regulatory correspondence concerning the Subject Product safety shall be promptly exchanged by the Parties via designated e-mail.
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Actions taken for Safety Reasons. If a Party becomes aware of any action that may or will be taken, or has been taken, by a regulatory authority for safety reasons with respect to the Product(s), such Party shall immediately and in no case more than three (3) calendar days from receipt of such notice notify the other Party in writing with any details regarding such action or pending action and shall keep the other Party advised of any additional details as soon as they become available.

Related to Actions taken for Safety Reasons

  • 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 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.

  • Root Cause Analysis Upon Vendor's failure to provide the Services in accordance with the applicable Service Levels (for any reason other than a Force Majeure Event) Vendor will promptly (a) perform a root-cause analysis to identify the cause of such failure, (b) provide Prudential with a report detailing the cause of, and procedure for correcting, such failure, (c) obtain Prudential's written approval of the proposed procedure for correcting such failure, (d) correct such failure in accordance with the approved procedure, (e) provide weekly (or more frequent, if appropriate) reports on the status of the correction efforts, and (f) provide Prudential with assurances satisfactory to Prudential that such failure has been corrected and will not recur.

  • Notice of Regulatory Action To the extent permitted by applicable Law, each Seller shall promptly notify the applicable Purchaser of any action, claim, inquiry, audit, investigation or examination taken or made by a Government Authority that may affect the conduct of a Serviced Appointment and shall consult with such Purchaser as to any changes in duties or other arrangements hereunder to be taken in connection therewith.

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

  • Consideration for Services In consideration for the Executive’s services, the Company shall pay and provide to the Executive the compensation and benefits set out in this Section 5, and the Executive shall accept the same, as full compensation and consideration for the performance of the services to be rendered by the Executive under this Agreement.

  • Authorization for Secured Party to Take Certain Action (a) Each Grantor irrevocably authorizes the Collateral Agent at any time and from time to time in the sole discretion of the Collateral Agent and appoints the Collateral Agent as its attorney in fact (i) to execute on behalf of such Grantor as debtor and to file financing statements necessary or desirable in the Collateral Agent’s sole discretion to perfect and to maintain the perfection and priority of the Collateral Agent’s security interest in the Collateral, (ii) to endorse and collect any cash Proceeds of the Collateral, (iii) to file a carbon, photographic or other reproduction of this Security Agreement or any financing statement with respect to the Collateral as a financing statement and to file any other financing statement or amendment of a financing statement (which does not add new collateral or add a debtor) in such offices as the Collateral Agent in its sole discretion deems necessary or desirable to perfect and to maintain the perfection and priority of the Collateral Agent’s security interest in the Collateral, (iv) to contact and enter into one or more agreements with the issuers of uncertificated securities which are Pledged Collateral or with securities intermediaries holding Pledged Collateral as may be necessary or advisable to give the Collateral Agent Control over such Pledged Collateral, (v) to apply the Proceeds of any Collateral received by the Collateral Agent to the Secured Obligations as provided in Section 7.3, (vi) to discharge past due taxes, assessments, charges, fees or Liens on the Collateral (except for such Liens as are specifically permitted hereunder), (vii) to contact Account Debtors for any reason, (viii) to demand payment or enforce payment of the Receivables in the name of the Collateral Agent or such Grantor and to endorse any and all checks, drafts, and other instruments for the payment of money relating to the Receivables, (ix) to sign such Grantor’s name on any invoice or xxxx of lading relating to the Receivables, drafts against any Account Debtor of such Grantor, assignments and verifications of Receivables, (x) to exercise all of such Grantor’s rights and remedies with respect to the collection of the Receivables and any other Collateral, (xi) to settle, adjust, compromise, extend or renew the Receivables, (xii) to settle, adjust or compromise any legal proceedings brought to collect Receivables, (xiii) to prepare, file and sign such Grantor’s name on a proof of claim in bankruptcy or similar document against any Account Debtor of such Grantor, (xiv) to prepare, file and sign such Grantor’s name on any notice of Lien, assignment or satisfaction of Lien or similar document in connection with the Receivables, (xv) to change the address for delivery of mail addressed to such Grantor to such address as the Collateral Agent may designate and to receive, open and dispose of all mail addressed to such Grantor, and (xvi) to do all other acts and things necessary to carry out this Security Agreement; and such Grantor agrees to reimburse the Collateral Agent on demand for any payment made or any expense incurred by the Collateral Agent in connection with any of the foregoing; provided that, this authorization shall not relieve such Grantor of any of its obligations under this Security Agreement or under the Credit Agreement.

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Notice of Material Actions / Change in Control The Sub-Adviser will keep the Trust and the Adviser informed of developments relating to its duties as subadviser of which the Sub-Adviser has, or should have, knowledge that would materially affect the Fund. The Sub-Adviser will promptly notify the Adviser in writing of the occurrence of any of the following events (i) it is served or otherwise receives notice of, or is threatened with, any material action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, governmental, administrative or self-regulatory agency, or public board or body, involving the affairs of the Fund and (ii) any change in the partners of the Sub-Adviser or in the actual control or management of the Sub-Adviser or change in the portfolio manager(s) primarily responsible for the day-to-day management of the Allocated Portion.

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