Government Notices; Adverse Events Notification Sample Clauses

Government Notices; Adverse Events Notification. Each party will provide the other with a copy of any correspondence or notices it receives from the FDA, DEA or any counterpart state agency specifically relating to Services or relating to a material violation of any kind that is related to the Company or the Product, whether such violation resulted from an act or omission by the Company or by ICS, no later than three (3) business days following such receipt. In addition, ICS will provide the Company with any notice relating to Products promptly upon its receipt. Each party will also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., such as an FDA 483 notice, warning letters, untitled regulatory letters and establishment inspection reports). Where reasonably possible, ICS will give prior notice to the Company of any scheduled FDA or DEA inspections of ICS’s facilities specifically relating to any Products, and, if reasonably possible, will afford the Company the opportunity to be present at such inspection and to review and contribute to any written response, to the extent permitted by law. ICS shall warm transfer any calls from a customer to Company at 1-855-EXPAREL if the customer reports information that relates, refers or pertains to: (i) an adverse or unexpected event in humans relating to the Products; (ii) a technical or other complaint relating to the Products; or (iii) any report of any other problem involving the Products (e.g., contamination, discoloration, improper labeling, adulteration, et cetera).
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Related to Government Notices; Adverse Events Notification

  • Notification Procedures To address non-compliance, the receiving Competent Authority would notify the providing Competent Authority pursuant to Article 5 of the IGA. The notification procedures would differ depending upon whether the receiving Competent Authority seeks to address administrative or other minor errors or significant non-compliance.

  • NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this IA shall be submitted to the following entities: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 LFAC: Xxxxxxx X. Xxxxx, DPM 0000 Xxxxxxxxxxx Xx. X-000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Email: xx.xxxxx@xxxxx.xxx Unless otherwise specified, all notifications and reports required by this IA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, LFAC may be required to provide OIG with an additional copy of each notification or report required by this IA in OIG’s requested format (electronic or paper).

  • Financial Information, Reports, Notices, etc Borrower will furnish, or will cause to be furnished, to the Administrative Agent and each Lender (via Intralinks or any other method reasonably acceptable to the Administrative Agent) copies of the following financial statements, reports, notices and information: (a) as soon as available and in any event within 45 days after the end of each of the first three Fiscal Quarters of each Fiscal Year of Borrower commencing with the Fiscal Quarter ending March 31, 2007, (i) a consolidated balance sheet of Borrower and its Subsidiaries as of the end of such Fiscal Quarter and consolidated statements of earnings and cash flow of Borrower and its Subsidiaries for such Fiscal Quarter and for the same period in the prior Fiscal Year and for the period commencing at the end of the previous Fiscal Year and ending with the end of such Fiscal Quarter (including a note with a consolidated statement of revenues, assets and EBITDA for each Non-Guarantor Subsidiary with revenues in excess of $5 million individually (and in the aggregate with revenues in excess of $10 million)), certified by a Financial Officer of Borrower as fairly presenting in all material respects the financial position, results of operations and cash flows of Borrower and its Subsidiaries in accordance with GAAP consistently applied, (ii) a narrative report and management’s discussion and analysis, in a form reasonably satisfactory to the Administrative Agent, of the financial condition and results of operations for such Fiscal Quarter and the then elapsed portion of the Fiscal Year, as compared to the comparable periods in the previous Fiscal Year and budgeted amounts and (iii) a management report in a form reasonably satisfactory to the Administrative Agent setting forth statement of income items and Consolidated EBITDA of Borrower for such Fiscal Quarter and for the then elapsed portion of the Fiscal Year, showing variance, by dollar amount and percentage, from amounts for the comparable periods in the previous Fiscal Year and budgeted amounts (it being understood that any such information may be furnished in the form of a Form 10-Q); (b) as soon as available and in any event within (x) 120 days (or such earlier time as Borrower may be required to file a Form 10-K with the SEC) after the end of Fiscal Year 2006 (it being agreed that Borrower shall furnish unaudited management accounts in the form of a consolidated balance sheet of Borrower and its Subsidiaries as of the end of such Fiscal Year and consolidated statements of earnings and cash flow of Borrower and its Subsidiaries for such Fiscal Year to the Administrative Agent and the Lenders within 105 days after the end of such Fiscal Year) and (y) 105 days after the end of each Fiscal Year of Borrower thereafter, a copy of the annual audit report for such Fiscal Year for Borrower and its Subsidiaries, including therein a consolidated balance sheet of Borrower and its Subsidiaries as of the end of such Fiscal Year and consolidated statements of earnings and cash flow of Borrower and its Subsidiaries for such Fiscal Year (including a note with a consolidated statement of revenues, assets and EBITDA for each Non-Guarantor Subsidiary with revenues in excess of $5 million individually (and in the aggregate with revenues in excess of $10 million)), in each case certified (without any Impermissible Qualification) by an independent public accounting firm reasonably acceptable to the Administrative Agent, and concurrently with the delivery of the foregoing financial statements, (i) a narrative report and management’s discussion and analysis, in a form reasonably satisfactory to the Administrative Agent, of the financial condition and results of operations of Borrower for such Fiscal Year, as compared to amounts for the previous Fiscal Year and budgeted amounts and (ii) a management report in a form reasonably satisfactory to the Administrative Agent setting forth statement of income items and Consolidated EBITDA of Borrower for such Fiscal Year, showing variance, by dollar amount and percentage, from the previous Fiscal Year and budgeted amounts (it being understood that any such information may be furnished in the form of a Form 10-K); (c) concurrently with the delivery of financial statements pursuant to Section 5.01(a) or (b), a Compliance Certificate containing a computation in reasonable detail of, and showing compliance with, each of the financial ratios and restrictions contained in the Financial Covenants and to the effect that, in making the examination necessary for the signing of such certificate, such Financial Officers have not become aware of any Default or Event of Default that has occurred and is continuing, or, if such Financial Officers have become aware of such Default or Event of Default, describing such Default or Event of Default and the steps, if any, being taken to cure it; provided that Compliance Certificates delivered in respect of periods prior to the Fiscal Quarter ending March 31, 2007, shall not be required to include computations showing compliance with the Financial Covenants; (d) as soon as practicable and in any event no later than 45 days after the end of each Fiscal Year, commencing with the beginning of Fiscal Year 2008, a detailed consolidated budget by Fiscal Quarter for such Fiscal Year (including a projected consolidated balance sheet and related consolidated statements of projected operations and cash flow as of the end of and for each Fiscal Quarter during such Fiscal Year); (e) promptly upon receipt thereof, copies of all material written final reports submitted to Holdco or Borrower by independent certified public accountants in collection with each annual, interim or special audit of the books of Holdco or any of its Subsidiaries made by such accountants, including any final management letters submitted by such accountants to management in connection with their annual audit; (f) promptly, and in any event within ten days, after becoming aware of the occurrence of any Default or Event of Default, a statement of a Financial Officer of Borrower setting forth reasonable details of such Default or Event of Default and the action which Borrower has taken and proposes to take with respect thereto; (g) promptly, and in any event within ten Business Days, after (i) the occurrence of any adverse development with respect to any litigation, action or proceeding against a Loan Party or any of its Subsidiaries that, would reasonably be expected to have a Material Adverse Effect or (ii) the commencement of any litigation, action or proceeding against a Loan Party or any of its Subsidiaries that would reasonably be expected to have a Material Adverse Effect or that disputes, or seeks to invalidate, the legality, validity or enforceability of any provision of this Agreement or any other Loan Document or the transactions contemplated hereby or thereby, notice thereof and, to the extent requested by the Administrative Agent, copies of all documentation relating thereto; (h) promptly after the sending or filing thereof, copies of all reports, registration statements or other materials (including affidavits with respect to reports) which Holdco or any of its Subsidiaries or any of their officers or directors files with the SEC or any national securities exchange; (i) promptly upon becoming aware of the taking of any specific actions by Holdco, any of its Subsidiaries or any other Person to terminate any Pension Plan (other than a termination pursuant to Section 4041(b) of ERISA which can be completed without Holdco, any of its Subsidiaries or any ERISA Affiliate having to provide more than $2,500,000 in addition to the normal contribution required for the plan year in which termination occurs to make such Pension Plan sufficient), or the occurrence of an ERISA Event which could result in a Lien on the assets of any Loan Party or any Subsidiary thereof or in the incurrence by a Loan Party of any liability, fine or penalty which would reasonably be expected to have a Material Adverse Effect, or any increase in the contingent liability of a Loan Party with respect to any post-retirement Welfare Plan benefit if the increase in such contingent liability which would reasonably be expected to have a Material Adverse Effect, notice thereof and copies of all documentation relating thereto; (j) upon request by the Administrative Agent, copies of: (i) each Schedule B (Actuarial Information) to the annual report (Form 5500 Series) filed by any Loan Party or ERISA Affiliate with the Internal Revenue Service with respect to each Pension Plan; (ii) to the extent available, the most recent actuarial valuation report for each Pension Plan; (iii) all notices received by any Loan Party or ERISA Affiliate from a Multiemployer Plan sponsor or any governmental agency concerning an ERISA Event; and (iv) such other documents or governmental reports or filings relating to any Plan as the Administrative Agent shall reasonably request; (k) promptly, and in any event within five Business Days, notice of any other development that has had a Material Adverse Effect; (l) promptly, from time to time, such other information respecting the condition or operations, financial or otherwise, of Holdco or any of its Subsidiaries as any Lender through the Administrative Agent may from time to time reasonably request, subject to confidentiality requirement imposed by law; and (m) with respect to each Test Period for which a Cure Right will be exercised, on the date the financial statements pursuant to Section 5.01(a) or (b) have been, or should have been, delivered for the applicable fiscal period, Borrower shall deliver together with such financial statements an Officer’s Certificate of a Financial Officer of Borrower containing a computation in reasonable detail of the applicable Event of Default and a notice of its intent to cure (a “Notice of Intent to Cure”) such Event of Default through the issuance of Permitted Cure Securities as contemplated pursuant to Section 7.04.

  • Notification of Recall Notification of recall from layoff shall be sent by certified mail, return receipt requested, deliverable to addressee only, to the employee's last known address. The notice shall give the employee a minimum of ten (10) calendar days within which to respond after the notice of recall has been mailed. Employees who decline recall or who, in the absence of extenuating circumstances, fail to respond within the time set for return to work, shall be presumed to have resigned and their name shall be removed from the seniority and preferred eligibility list.

  • Regulation AB Notices With respect to any notice required to be delivered by the Certificate Administrator to the Depositor pursuant to this Article X, the Certificate Administrator may deliver such notice, notwithstanding any contrary provision in this Agreement, via facsimile and electronic mail to Citigroup Commercial Mortgage Securities Inc., 000 Xxxxxxxxx Xxxxxx, 0xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, Attention: Xxxx Xxxxxxxxxxx, telecopy number: (000) 000-0000, e-mail: xxxx.x.xxxxxxxxxxx@xxxx.xxx, with a copy to Citigroup Global Markets Inc., 000 Xxxxxxxxx Xxxxxx, 0xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, Attention: Xxxxxxx Xxxxxxx, telecopy number: (000) 000-0000 e-mail: xxxxxxx.xxxxxxx@xxxx.xxx, and with a copy to Citigroup Global Markets Inc., 000 Xxxxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, Attention: Xxxx X. X’Xxxxxx, telecopy number: (000) 000-0000, e-mail: xxxx.x.xxxxxxx@xxxx.xxx, or to such other address(es), facsimile numbers and/or electronic mail addresses as may be designated by the Depositor.

  • Notification of Government Investigation or Legal Proceeding Provider shall notify OIG, in writing, of any ongoing investigation or legal proceeding by a governmental entity or its agents involving an allegation that Provider has committed a crime or has engaged in fraudulent activities, within 30 days of Provider receiving notice of such investigation or legal proceeding. This notification shall include a description of the allegation(s), the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. Within 30 days after resolution of the matter, Provider shall notify OIG, in writing, of the resolution of the investigation or legal proceeding.

  • Notices from Governmental Authority promptly, and in any event within 30 days of receipt thereof, copies of any notice to the Company or any Subsidiary from any Federal or state Governmental Authority relating to any order, ruling, statute or other law or regulation that could reasonably be expected to have a Material Adverse Effect; and

  • SUBMISSION OF THE MONTHLY MI REPORT 4.1 The completed MI Report shall be completed electronically and returned to the Authority by uploading the electronic MI Report computer file to MISO in accordance with the instructions provided in MISO. 4.2 The Authority reserves the right (acting reasonably) to specify that the MI Report be submitted by the Supplier using an alternative communication to that specified in paragraph 4.1 above such as email. The Supplier agrees to comply with any such instructions provided they do not materially increase the burden on the Supplier.

  • Publication of Notices Any obligation the Agents may have to publish a notice to Holders of Global Notes on behalf of the Issuer will be met upon delivery of the notice to DTC.

  • CONTRACT ADMINISTRATION & NOTICES Except for legal notices, the parties hereby designate the following contract administrators as the respective single points of contact for purposes of this Master Contract. Enterprise Services’ contract administrator shall provide Master Contract oversight. Contractor’s contract administrator shall be Contractor’s principal contact for business activities under this Master Contract. The parties may change contractor administrators by written notice as set forth below. Any notices required or desired shall be in writing and sent by U.S. mail, postage prepaid, or sent via email, and shall be sent to the respective addressee at the respective address or email address set forth below or to such other address or email address as the parties may specify in writing:

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