ANNUAL REPORT TO FDA Sample Clauses

ANNUAL REPORT TO FDA. BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. Approvals Print Name Signature Date
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ANNUAL REPORT TO FDA. BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. Approvals Print Name Signature Date SAVIENT QA Xxxx Xxxxxxxxx /s/Xxxx Xxxxxxxxx 19-FEB-2009 BTG QA Xxxxxx Xxxxxx /s/Xxxxxx Xxxxxx 19/02/09

Related to ANNUAL REPORT TO FDA

  • Annual Reports Within one hundred twenty (120) days after the last day of each fiscal year of Holdings commencing with the fiscal year ending December 31, 2018 (but one hundred fifty (150) days for the fiscal year ending December 31, 2018), a copy of the consolidated balance sheet of Holdings and its Restricted Subsidiaries as of the last day of the fiscal year then ended and the consolidated statements of income and cash flows of Holdings and its Restricted Subsidiaries for the fiscal year then ended, and accompanying notes thereto, each in reasonable detail showing in comparative form the figures for the previous fiscal year (starting with the fiscal year ending December 31, 2019) accompanied in the case of the consolidated financial statements by an opinion of an independent public accounting firm of recognized national standing or other accounting firm selected by the Borrower and reasonably acceptable to the Administrative Agent (which opinion shall be unqualified as to scope, subject to the proviso below) to the effect that the consolidated financial statements have been prepared in accordance with GAAP and present fairly in all material respects the consolidated financial condition and results of operations and cash flows of Holdings and its Restricted Subsidiaries as of the close of and for such fiscal year; provided that such financial statements shall not contain a “going concern” qualification or statement, except to the extent that such a “going concern” qualification or statement relates to (A) the report and opinion accompanying the financial statements for the fiscal year ending immediately prior to the stated final maturity date of the Loans, Permitted Pari Passu Refinancing Debt, Permitted Unsecured Refinancing Debt or Permitted Junior Refinancing Debt and which qualification or statement is solely a consequence of such impending stated final maturity date or (B) any potential inability to satisfy the Financial Covenants, or any financial covenant under any other Indebtedness on a future date or in a future period; in each case, such financial statements shall be accompanied by a customary management discussion and analysis of the financial performance of Holdings and its Restricted Subsidiaries;

  • Annual Report Within 90 days after each April 15, starting in the year after the Closing Date, the Indenture Trustee will prepare and mail to each Noteholder a report dated as of April 15 of the applicable year that complies with Section 313(a) of the TIA, if the report is required under Section 313(a) of the TIA. The Indenture Trustee will also prepare and mail to the Noteholders any report required under Section 313(b) of the TIA. A report mailed to the Noteholders under this Section 7.4(a) will be mailed according to Section 313(c) of the TIA.

  • Annual Reports; Etc Promptly after the same are available, copies of each annual report, proxy or financial statement or other report or communication sent to the stockholders of the Borrower, and copies of all annual, regular, periodic and special reports and registration statements which the Borrower may file or be required to file with the SEC under Section 13 or 15(d) of the Securities Exchange Act of 1934, or with any national securities exchange, and in any case not otherwise required to be delivered to the Administrative Agent pursuant hereto.

  • Annual Reporting Within 90 days after the close of each of its respective fiscal years, audited, unqualified consolidated financial statements (which shall include balance sheets, statements of income and retained earnings and a statement of cash flows) for Provider for such fiscal year certified in a manner acceptable to the Agent by independent public accountants acceptable to the Agent.

  • Plan Annual Reports Promptly and in any event within 30 days after the filing thereof with the Internal Revenue Service, copies of each Schedule B (Actuarial Information) to the annual report (Form 5500 Series) with respect to each Plan.

  • Quarterly Financial Reports The School shall prepare and submit quarterly financial reports to the Commission within 45 days of the end of each fiscal year quarter.

  • Quarterly Reports Following submission of the initial report, quarterly performance reports until submission of the final report described in the following subparagraph. Reports are due on January 30, April 30, July 30, and October 30.

  • Quarterly Reporting If reporting is on a quarterly basis, the AGENCY shall submit to the Orange County Citizens’ Commission for Children a complete, accurate, and programmatic Quarterly Report, in a format as provided by the COUNTY, on or before the 10th of the month following the close of the quarter, as well as supporting documentation. The Quarterly Reports shall, if applicable to the Scope of Work in Attachment “A”, list “Units of Service” provided (i.e.: hourly, per session, etc.) and/or any other pertinent outcome measurements outlined in Attachment “A”.

  • Quarterly Report 5.1 Upon request, the contractor shall provide to the Purchasing Agent a quarterly report, showing all purchases made under the terms and conditions of the contract. 5.2 Such quarterly report shall itemize the following information: 1. Each ordering department. 2. Items and quantities purchased by department. 3. Total dollar amount of purchases by department.

  • Quarterly Review For a period commencing on the initial effective date of the Registration Statement and ending five years from the date of the consummation of the Business Combination or until such earlier time at which the Liquidation occurs or the Common Stock and Warrants cease to be publicly traded, the Company, at its expense, shall cause its regularly engaged independent registered public accounting firm to review (but not audit) the Company’s financial statements for each of the first three fiscal quarters prior to the announcement of quarterly financial information, the filing of the Company’s Form 10-Q quarterly report and the mailing, if any, of quarterly financial information to stockholders.

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