Audited Site definition

Audited Site means any site or facility of a Party or any of its Affiliates, Third Party sublicensees, or Third Party contractors or subcontractors hereunder, as the case may be, on which any clinical study or Manufacturing of Licensed Products for human use is conducted, and which is undergoing an inspection or audit by a Regulatory Authority or a Party as provided hereunder.
Sample 1Sample 2Sample 3
Audited Site has the meaning set forth in Section 4.3(d).
Sample 1Sample 2
Audited Site shall have the meaning set out in clause 6.6.5.
Sample 1

Examples of Audited Site in a sentence

  • IDEMIA CC Audited Production Sites/PlantsIDEMIA CC Audited Production Sites are listed below: Table 4 : Audited Production Sites (Option 1) Image Loading audited IC Manufacturer siteFLASH image containing both the “ID-One Cosmo X” Java Card Platform OS along with the CombICAO Applet v3 is securely delivered directly from the software developer (IDEMIA R&D Audited Site) to the IC Manufacturer (Infineon CC Audited Site) to be loaded into FLASH memory.

  • PackageTable 5 Option 1: Both Platform and Applet packages are loaded at IC Manufacturer Site (Option 2) Image loading at IDEMIA and External sitesFLASH image containing both ID-One Cosmo X Platform along with CombICAO Applet v3 is securely delivered directly from the software developer (IDEMIA R&D Audited Site) for loading to CC Audited IDEMIA Production Sites (Refer Audited Production Sites Table) or Non-Audited IDEMIA Sites or External Sites.

  • The applet code will be integrated into FLASH by the IC manufacturer on top of the platform already loaded by IC manufacturer (NXP), or(Option 2) the TnD v5.1 application with Common package and Adapter package and the guidance documentation are securely delivered directly from the software developer (IDEMIA R&D Audited Site) to the travel document manufacturer (IDEMIA Audited Production Sites or IDEMIA Non-Audited Sites) for production.

  • Depending on the intention:(Option 1) the TnD v5.1 application with Common package and Adapter package is securely delivered directly from the software developer (IDEMIA R&D Audited Site) to the IC manufacturer (NXP Audited Site).

  • The TnD v5.1 Applet with its Common package along with the TOE’s guidance documentation is securely delivered directly from the Software Developer (IDEMIA R&D Audited Site) to Audited IDEMIA Production Sites (Haarlem, Noida, Vitré, Shenzhen, Ostrava) or Non- Audited IDEMIA Sites or External Sites.Loading of the TnD v5.1 Applet and its Common package on top of the already present COSMO X GP Java Card OS in any of these sites is accomplished by using a GP CLFDB decryption Key.

  • PackageTable 4 Option 1: Both Platform and Applet packages are loaded at IC Manufacturer Site (Option 2) Image loading at IDEMIA and External sitesFLASH image containing both ID-One Cosmo X Platform along with CombICAO Applet v3 is securely delivered directly from the software developer (IDEMIA R&D Audited Site) for loading to CC Audited IDEMIA Production Sites (Refer Audited Production Sites Table) or Non- Audited IDEMIA Sites or External Sites.

  • The applet code will be integrated into FLASH by the IDEMIA Audited Production Sites or Non-Audited Sites on top of the platform already loaded by IC manufacturer (NXP), or (Option 3) the TnD v5.1 application with Common package and Adapter package and the guidance documentation are securely delivered directly from the software developer (IDEMIA R&D Audited Site) to external authorized agent (other external sites) for production.

  • Table 9 Option 1: Both Platform and Applet packages are loaded at IC Manufacturer Site (Option 2) Image loading at IDEMIA and External sitesFLASH image containing both Cosmo X Platform along with TnD v5.1 Applet and Common package is securely delivered directly from the software developer (IDEMIA R&D Audited Site) for loading to CC Audited IDEMIA Production Sites (Haarlem, Noida, Vitré, Shenzhen or Ostrava) or Non-Audited IDEMIA Sites or External Sites.

  • Depending on the intention: (Option 1) the developer sends the image (containing both the Java Card platform and the Tachograph applet) to be flashed in the IC to the IC Manufacturer Audited Site in the phase 3.Or (Option 2) the platform developer sends the image (containing only the Java Card platform) to be flashed in the IC to the IC manufacturer in the phase 3.

  • In the event that any Audited Site is found to be non- compliant with one or more GMP standards, Surface will submit to GSK a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) as soon as reasonably practicable after Surface, its Affiliate or its permitted subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and Surface will use reasonable efforts, at Surface’s cost, to implement such recovery plan or CAPA promptly after submission.


More Definitions of Audited Site

Audited Site means any site or facility of a Party or any of its Affiliates, Third Party sublicensees, or Third Party contractors or subcontractors hereunder, as the case may be, on which any Clinical Trial or Manufacturing of Licensed Products for human use is conducted, and which is undergoing an inspection or audit by a Regulatory Authority or a Party as provided hereunder. 1.34 “Auditing Party” has the meaning set forth in Section 7.5.2. 1.35 “Bankrupt Party” has the meaning set forth in Section 13.3.1. 1.36 “Bankruptcy” means, with respect to a Party, that: (a) the Party has been declared insolvent or bankrupt by a court of competent jurisdiction; (b) a voluntary or involuntary petition for protection under any bankruptcy or insolvency laws (including under the Bankruptcy Code) is filed in any court of competent jurisdiction against the Party and such petition has not discharged or dismissed within forty (40) Business Days after filing; (c) the Party has made or executed an assignment of substantially all of its assets for the benefit of creditors; (d) proposes a written agreement of composition or extension of its debts; (e) proposes or is a party to any dissolution or liquidation of such Party; or (f) admits in writing its inability generally to meet its obligations as they fall due in the general course. 1.37 “Bankruptcy Code” means Title 11 of the United States Code, as may be amended or superseded from time to time. 1.38 “Bankruptcy Commencement Date” has the meaning set forth in Section 13.3.2. 1.39 “Breaching Party” has the meaning set forth in Section 13.2.1. 1.40 “Business Day” shall mean a day other than a Saturday, Sunday or public holiday in United States and England when banks in United States and England are open for normal banking business and excluding the period from 24 December to 2 January in which the corporate offices of GSK are closed for business. 1.41 “Calendar Quarter” means each three (3) month period commencing January 1, April 1, July 1 or October 1 of any Calendar Year; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Amended Effective Date to the end of the first full Calendar Quarter thereafter; and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement. 1.42 “Calendar Year” means the period beginning on January 1 and ending on December 31 of the same year; provided, however, that (a) the first Calendar Year of the Term shall commence on the Ame...
Sample 1
Audited Site means any site or facility of a Party or any of its Affiliates, Third Party sublicensees, or Third Party contractors (such as under any Existing Third Party Agreement) or subcontractors hereunder, as the case may be, in which any clinical study or manufacturing of Licensed Products for human use is conducted, and which is undergoing an inspection or audit by a Regulatory Authority or a Party as provided hereunder, such as pursuant to Section 4.11.3 or Section 7.4.2.
Sample 1

Related to Audited Site

  • Audited Statements means the Consolidated balance sheets of the Borrower as at December 31, 2000, and the related Consolidated statements of income and cash flows of the Borrower for the fiscal year then ended, accompanied by the opinion thereon of the Borrower's independent public accountants.

  • Annual Statement means, with respect to any Insurance Subsidiary for any fiscal year, the annual financial statements of such Insurance Subsidiary as required to be filed with the Insurance Regulatory Authority of its jurisdiction of domicile and in accordance with the laws of such jurisdiction, together with all exhibits, schedules, certificates and actuarial opinions required to be filed or delivered therewith.

  • Audited Party means the Party being audited by the Auditing Party.

  • audited when used in regard to financial statements shall mean an examination of the financial statements by a firm of independent certified public accountants in accordance with generally accepted auditing standards for the purpose of expressing an opinion thereon.

  • environmental statement means the document certified as the environmental statement by the Secretary of State for the purposes of the Order;

  • Audited Company Balance Sheet means the consolidated balance sheet (and the notes thereto) of the Company and its consolidated Subsidiaries as of December 31, 2021, set forth in the Company’s Annual Report on Form 10-K filed by the Company with the SEC for the fiscal year ended December 31, 2021.

  • Company Audited Financial Statements has the meaning set forth in Section 3.11.

  • Audited financial statement means a financial statement audited by an outside accounting firm.

  • Annual Statement of Compliance As defined in Section 3.13.

  • Audited Financial Statements means the audited consolidated balance sheet of the Borrower and its Subsidiaries for the fiscal year ended December 31, 2017, and the related consolidated statements of income or operations, shareholders’ equity and cash flows for such fiscal year of the Borrower and its Subsidiaries, including the notes thereto.

  • Financial Statements Date shall have the meaning ascribed to it in Section 3.7.

  • Audited financial report means and includes those items specified in Section 5 of this regulation.

  • Pre-Contractual Statement means a draft agreement, undertaking, representation, warranty, promise, assurance or arrangement of any nature whatsoever, whether or not in writing, relating to this Agreement made or given by a Party to this Agreement or any other person at any time prior to the date of this Agreement.

  • the environmental statement means the document certified as the environmental statement by the Secretary of State for the purposes of the Order;

  • Audited Financials has the meaning specified in Section 4.6(a).

  • Financial Statement Date means December 31, 1999.

  • Year-End Financial Statements has the meaning set forth in Section 3.06.

  • Consolidated Rental Expense means, for any period, on a consolidated basis for the Company and its Subsidiaries, the aggregate amount of fixed and contingent rentals payable in cash by the Company and its Subsidiaries with respect to leases of real and personal property (excluding capital lease obligations) determined in accordance with GAAP for such period (subject to Section 1.04(b)).

  • Statutory Financial Statements means, with respect to any Party, the annual and quarterly statutory financial statements of such Party filed with the Governmental Authority charged with supervision of insurance companies in the jurisdiction of domicile of such Party to the extent such Party is required by Applicable Law to prepare and file such financial statements.

  • Phase I Environmental Report means a report by an Independent Person who regularly conducts environmental site assessments in accordance with then current standards imposed by institutional commercial mortgage lenders and who has a reasonable amount of experience conducting such assessments.

  • Environmental Report The environmental audit report or reports with respect to each Mortgaged Property delivered to the related Mortgage Loan Seller in connection with the origination or acquisition of the related Mortgage Loan.

  • Target Financial Statements has the meaning set forth in Section 3.4.

  • Unaudited Financial Statements has the meaning set forth in Section 5.14.

  • Environmental impact statement means a detailed written statement as required by section 102(2)(C) of the Act.

  • Audited Balance Sheet means the audited balance sheet of the company prepared for the purposes of the Companies Acts for a financial year unless an audited consolidated balance sheet dealing with the state of affairs of the company and its subsidiary undertakings required to be dealt with in group accounts has been prepared for those purposes for the same financial year, in which case it means that audited consolidated balance sheet, and in that case all references to reserves shall be deemed to be references to consolidated reserves;

  • Final Statement means the statement defined in Sub-Clause 14.11 [Application for Final Payment Certificate].