FIELD ALERT REPORTING Sample Clauses

FIELD ALERT REPORTING. If PowderJect receives information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in a Gas Cylinder supplied to AlgoRx, or any failure of one or more batches of Gas Cylinders supplied to AlgoRx to meet the Gas Cylinder Specification (a "FIELD ALERT"), PowderJect shall notify AlgoRx immediately by telephone (to be confirmed in writing within twenty-four (24) hours). AlgoRx shall be responsible for receiving, investigating, and documenting all such information relating to such Field Alerts. AlgoRx will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations. PowderJect will cooperate as reasonably required by AlgoRx with the investigation of such incidents. If the Field Alert arises out of PowderJect's failure to supply Gas Cylinders that were Manufactured in compliance with GMP or that conform to the Gas Cylinder Specification, PowderJect shall bear the cost and expense of investigating and responding to such Field Alert, and shall use diligent efforts to replace the affected Gas Cylinders with replacement Gas Cylinders Manufactured in compliance with GMP that conform to the Gas Cylinder Specification as soon as reasonably practicable. In the event
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FIELD ALERT REPORTING. If either party receives information concerning any viral, bacterial, or similar contamination, or any significant chemical, physical, or other change or deterioration in a distributed Conor Device incorporating Product, or any failure of any distributed Conor Device incorporating Product to meet the Product Specifications or other CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. relevant specifications (a “Field Alert”), such party shall notify the other party immediately by telephone (to be confirmed in writing within twenty-four (24) hours). Conor shall be responsible for investigating and documenting all such information relating to Field Alerts. Conor will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations. Phytogen will cooperate as reasonably required by Conor with the investigation of such incidents. Subject to a full investigation by the Regulatory Committee, to the extent it is determined that the Field Alert arises out of Phytogen’s failure to manufacture the Product in compliance with GMP or other applicable laws or regulations or in conformance with the Product Specifications and Conor did not handle the Product in any manner which altered or caused to be defective the Product or otherwise caused such failure, Phytogen shall bear the cost and expense of investigating and responding to such Field Alert, and shall provide an amount of Product that has been manufactured the affected Product compliance with GMP and other applicable laws and regulations and that conform to the Product Specifications necessary to produce the number of Conor Devices equal to the quantity of Conor Devices incorporating Product that are the subject of the Field Alert within sixty (60) days from the date that Phytogen becomes aware of such Field Alert.
FIELD ALERT REPORTING. If either Party receives any information with respect to Licensed Products (a) concerning any incident that causes the Licensed Product or its labeling to be mistaken for, or applied to another article, or (b) concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in a distributed Licensed Product, or any failure of one or more distributed Batches to meet the Specifications (a "FIELD ALERT"), such Party shall notify the other Party immediately in person or by telephone, facsimile, or email (to be confirmed in writing within the reasonable period to be agreed in the Quality Memorandum). Peninsula shall be responsible for receiving, investigating, and documenting all such information relating to such Field Alerts. Peninsula will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations in the Territory. Shionogi will cooperate as reasonably required by Peninsula with the investigation of such incidents in the Territory. If the Field Alert arises out of Shionogi's failure to manufacture the Licensed Products in compliance with GMP or other applicable laws or regulations or in conformance with the Specifications,

Related to FIELD ALERT REPORTING

  • Adverse Event Reporting Sage shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate to the reporting and investigation of any adverse event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol. Probe Study Product-related or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product or Licensed Product. Sage shall provide CyDex with copies of ***Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product or the Licensed Product that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which Sage has reason to believe are associated with Captisol within 10 business days following (i) Sage’s submission of any such report to any regulatory agency, or (ii) receipt from Sage’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Sage shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General Counsel, Ligand, at the address set forth in Section 14.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by Sage, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Sage.

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • Management Reporting (a) Provide periodic reports, in accordance with agreed upon frequency and content parameters, to the Funds. As reasonably requested by the Funds, the Transfer Agent shall furnish ad hoc reports to the Funds.

  • Periodic Reporting (i) The MTHC Common Stock has been registered under Section 12 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") and MTHC is subject to the periodic reporting requirements of Section 13 of the Exchange Act. MTHC has heretofore provided to iTechexpress and the iTechexpress Shareholders true, complete, and correct copies of all forms, reports, schedules, statements, and other documents required to be filed by it under the Exchange Act since at least August 8, 2003,as such documents have been amended since the time of the filing thereof (the "MTHC SEC Documents"). The MTHC SEC Documents, including, without limitation, any financial statements and schedules included therein, at the time filed or, if subsequently amended, as so amended, (i) did not contain any untrue statement of a material fact required to be stated therein or necessary in order to make the statements therein not misleading and (ii) complied in all respects with the applicable requirements of the Exchange Act and the applicable rules and regulations thereunder. The financial statements included in the MTHC SEC Documents complied when filed as to form in all material respects with applicable accounting requirements and with the published rules and regulations of the SEC with respect thereto, have been prepared in accordance with generally accepted accounting principles in the United States, applied on a consistent basis during the periods involved (except as may be indicated in the notes thereto or, in the case of unaudited financial statements, as permitted by the rules and regulations of the Commission) and fairly present, subject in the case of the unaudited financial statements, to customary year end audit adjustments, the financial position of MTHC as at the dates thereof and the results of its operations and cash flows.

  • Monthly Reporting Notwithstanding anything to the contrary in the Servicing Agreement, with respect to the Mortgage Loans, not later than the tenth calendar day of each month (or if such tenth calendar day is not a Business Day, the immediately succeeding Business Day), the Servicer shall furnish to the Master Servicer (i)(a) monthly loan data in the format set forth in Exhibit B hereto (or in such other format mutually agreed upon between the Servicer and the Master Servicer), (b) default loan data in the format set forth in Exhibit C hereto (or in such other format mutually agreed upon between the Servicer and the Master Servicer and (c) information regarding the realized losses and gains in the format set forth in Exhibit D hereto (or in such other format mutually agreed upon between the Servicer and the Master Servicer), in each case relating to the period ending on the last day of the preceding calendar month, (ii) all such information required pursuant to clause (i)(a) above on a magnetic tape, electronic mail, or other similar media reasonably acceptable to the Master Servicer, and (iii) all supporting documentation with respect to the information required under the preceding paragraph.

  • Information Reporting (a) The Fund agrees that, during the Current Special Rate Period and so long as BANA or any Affiliate thereof is the beneficial owner of any Outstanding VRDP Shares, it will deliver, or direct the Tender and Paying Agent to deliver, to BANA and any such Affiliate:

  • Compliance Reporting a. Provide reports to the Securities and Exchange Commission, the National Association of Securities Dealers and the States in which the Fund is registered.

  • EXCHANGE ACT REPORTING AND REGULATION AB COMPLIANCE Section 13.1 Intent of the Parties; Reasonableness. Except with respect to Section 13.9, Section 13.10 and Section 13.11, the parties hereto acknowledge and agree that the purpose of this Article XIII is to facilitate compliance by the Depositor with the provisions of Regulation AB and related rules and regulations of the Commission. Neither the Depositor nor the Certificate Administrator shall exercise its right to request delivery of information or other performance under these provisions other than in reasonable good faith, or (except with respect to Section 13.9, Section 13.10 or Section 13.11) for purposes other than compliance with the Securities Act, the Exchange Act, the Sxxxxxxx-Xxxxx Act and, in each case, the rules and regulations of the Commission thereunder. The parties hereto acknowledge that interpretations of the requirements of Regulation AB may change over time, whether due to interpretive guidance provided by the Commission or its staff, or otherwise, and agree to comply with reasonable requests made by the Depositor or the Certificate Administrator in good faith for delivery of information under these provisions on the basis of such evolving interpretations of the requirements of Regulation AB (to the extent such interpretations require compliance and are not “grandfathered” and do not mandate compliance). In connection with the Mxxxxx Sxxxxxx Bank of America Mxxxxxx Lxxxx Trust 2013-C10 transaction, each of the parties to this Agreement shall cooperate fully with the Depositor and the Certificate Administrator, as applicable, to deliver or make available to the Depositor or the Certificate Administrator, as applicable (including any of their assignees or designees), any and all statements, reports, certifications, records and any other information in its possession and necessary in the reasonable good faith determination of the Depositor or the Certificate Administrator, as applicable, to permit the Depositor to comply with the provisions of Regulation AB, together with such disclosure relating to the Master Servicer, the Special Servicer, the Trust Advisor, the Trustee, the Custodian and the Certificate Administrator, as applicable, and any Sub-Servicer, or the servicing of the Mortgage Loans, reasonably believed by the Depositor or the Certificate Administrator, as applicable, to be necessary in order to effect such compliance. None of the Master Servicer, the Trust Advisor, the Trustee, the Custodian, any Sub-Servicer or the Special Servicer are responsible for filing any Exchange Act report with the Commission on behalf of the Trust. Each party to this Agreement shall have a reasonable period of time to comply with any written request made under this Section 13.1, but in any event, shall, upon reasonable advance written request, provide information in sufficient time to allow the Depositor or the Certificate Administrator, as applicable, to satisfy any related filing requirements. For purposes of this Article XIII, to the extent any party has an obligation to exercise commercially reasonable efforts to cause a third party to perform, such party hereunder shall not be required to bring any legal action against such third party in connection with such obligation.

  • Quarterly Reporting Within 45 days after the close of the first three (3) quarterly periods of each of its respective fiscal years, to the extent not furnished under the Purchase Agreement, (A) consolidated balance sheets of Provider and its Subsidiaries as at the close of each such period and (B) consolidated statements of income and retained earnings and a statement of cash flows for Provider for the period from the beginning of such fiscal year to the end of such quarter, all certified by its respective chief financial officer or treasurer.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

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