Additional Filing Data Sample Clauses

Additional Filing Data. During the Term of the Agreement, Baxter will, following prior written agreement with Cadence, provide the FDA and all other Regulating Groups in the Territory, with additional data and information related to the Product which are required for Cadence to obtain and maintain registration and approval of the Product in good standing in the Territory, including without limitation, Pre-Existing Specifications, Baxter Background Intellectual Property Rights and Original Product Data. Baxter reserves the right to inform the FDA and other Regulating Groups that such information is confidential and to advise the FDA and such Regulating Groups that Cadence will be entitled to reference such information on a confidential basis during the Term of the Agreement.
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Additional Filing Data. During the Term of this Agreement, Baxter will, following prior written notice to EKR, provide the FDA and all other Regulatory Authorities in the Territory, with the USCDMF and any other Baxter Container related data and information that are required for EKR to obtain and maintain registration and approval of the Product in good standing in the Territory. Baxter reserves the right to inform the FDA and other Regulatory Authorities that to the extent appropriate, such information is confidential. Baxter will advise the FDA and such Regulatory Authorities, in the form of a written authorization, that EKR will be entitled to reference such information on a confidential basis during the Term of this Agreement.
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Additional Filing Data. During the term of the Agreement, Solvay shall provide Cadence for submission to applicable Regulatory Authorities, additional data and information related to the Bulk Drug Substance that are required for Cadence (or any Cadence Affiliate or Sublicensee) to obtain and maintain registration and approval of the Drug Product in good standing.
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Additional Filing Data. During the Term of the Agreement, Baxter will, following prior written review and approval of Cadence, provide the Regulating Groups such additional data and information related to the Product as are required for Cadence to obtain and maintain registration and approval of the Product in good standing in the Territory, including without limitation, Pre-Existing Specifications, Baxter Background Intellectual Property Rights and Original Product Data. Baxter reserves the right to inform the Regulating Groups that such information is confidential and to advise the Regulating Groups that Cadence will be entitled to reference such information on a confidential basis during the Term of the Agreement. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to Additional Filing Data

  • Additional Filings Unless filed pursuant to Rule 462(c) as part of the Additional Registration Statement in accordance with the next sentence, the Company will file the Final Prospectus, in a form approved by the Representatives, with the Commission pursuant to and in accordance with subparagraph (1) (or, if applicable and if consented to by the Representatives, subparagraph (4)) of Rule 424(b) not later than the earlier of (A) the second business day following the execution and delivery of this Agreement or (B) the fifteenth business day after the Effective Time of the Initial Registration Statement. The Company will advise the Representatives promptly of any such filing pursuant to Rule 424(b) and provide satisfactory evidence to the Representatives of such timely filing. If an Additional Registration Statement is necessary to register a portion of the Offered Securities under the Act but the Effective Time thereof has not occurred as of the execution and delivery of this Agreement, the Company will file the additional registration statement or, if filed, will file a post-effective amendment thereto with the Commission pursuant to and in accordance with Rule 462(b) on or prior to 10:00 P.M., New York time, on the date of this Agreement or, if earlier, on or prior to the time the Final Prospectus is finalized and distributed to any Underwriter, or will make such filing at such later date as shall have been consented to by the Representatives.

  • Additional Financial Information The Company shall provide Parent with the Company’s audited financial statements for the twelve month periods ended December 31, 2022 and 2021 consisting of the audited consolidated balance sheets as of such dates, the audited consolidated income statements for the twelve month period ended on such date, and the audited consolidated cash flow statements for the twelve month period ended on such date (the “Year End Financials”). Subsequent to the delivery of the Year End Financials, the Company’s consolidated interim financial information for each quarterly period thereafter shall be delivered to Parent no later than forty (40) calendar days following the end of each quarterly period and consolidated interim monthly information for each month thereafter shall be delivered to Purchaser no later than 20 days following the end of each month (the “Required Financial Statements”). All of the financial statements to be delivered pursuant to this Section 7.3, shall be prepared under U.S. GAAP in accordance with requirements of the PCAOB for public companies. The Required Financial Statements shall be accompanied by a certificate of the Chief Executive Officer of the Company to the effect that all such financial statements fairly present the financial position and results of operations of the Company as of the date or for the periods indicated, in accordance with U.S. GAAP, except as otherwise indicated in such statements and subject to year-end audit adjustments. The Company will promptly provide with additional Company financial information reasonably requested by Parent for inclusion in the Proxy Statement and any other filings to be made by Parent with the SEC.

  • Additional Financial Statements Seller shall promptly furnish to Buyer a copy of all Financial Statements for each additional month-end period beyond the Balance Sheet Date as soon as same is regularly prepared by Seller in the Ordinary Course of Business. All such additional Financial Statements shall be subject to the same representations and warranties as contained in Section 3.23

  • BACKGROUND STATEMENT NCR Voyix and Customer agree that this Agreement will apply to: (a) the subscription licensing to Customer of Software at selected Customer sites and Hosted Software accessed via the internet; (b) the subscription or purchase of Equipment by Customer; and (c) NCR Voyix’s maintenance and support services, if any, for such Software and Equipment, as well as certain other services as set forth herein. Payment processing services are not covered by this Agreement. If NCR Voyix provides payment processing services as part of a Product bundle or otherwise, then such processing services will be covered by separate agreement.

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information.