Internal FTE Budgeting Sample Clauses

Internal FTE Budgeting. As part of the process of producing the Annual Commercialization Plan and Budget and the Annual Development Plan and Budget, the Parties may determine, but shall not be obligated (except as may be required pursuant to an Existing Agreement) to provide one another with their estimate of, internal FTE resources required for (1) all Development and related regulatory activities under the Annual Development Plan and Budget and (2) all non-Sales Force Commercialization and related regulatory activities under the Annual Commercialization Plan and Budget, for Final Product for such year. If the JJDC agrees that the internal FTE efforts in the aggregate to be expended by each Party Group (including by any Affiliates of the Parties within such Party Group) for (A) for Clinical Trials conducted pursuant to the Annual Development Plan and Budget and (B) for regulatory activities reasonably allocable to the Development of Cetuximab or Final Product in Japan are expected to be essentially equivalent, then, except as provided in Section 4.1(c)(i) and 4.1(c)(ii) below, the Parties need not express any Development or related regulatory activity (whether individually or in the aggregate) in the Annual Development Plan and Budget in terms of FTEs, but shall designate within such Annual Development Plan and Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. Budget those Development and related regulatory activities that will be performed by the relevant Party Group. If the JJCC agrees that the internal FTE efforts in the aggregate to be expended by each Party Group (including by any Affiliates of the Parties within such Party Group) for all Commercialization (but not taking into account for this purpose Sales Representative Detailing activities) activities, any related regulatory activities and all Medical Education Activities are expected to be essentially equivalent (with ImClone’s FTEs to be taken into account for such purposes only with respect to those regulatory activities, if any, related to Commercialization that are to be performed by ImClone under the Annual Commercialization Plan and Budget), then, except as provided in Section 4.1(c)(i) and 4.1(c)(ii) below, the Parties need not express any individual Commercialization activities, Medical Education Activities, or related regulatory activity (whether individually or in the aggregate) in the Annual Commercialization Plan and Budget in terms of FTEs, but shall de...
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Related to Internal FTE Budgeting

  • Budgeting The budget set out in the Consortium Plan shall be valued in accordance with the usual accounting and management principles and practices of the respective Parties.

  • Internal Controls The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

  • Internal Control Effective control and accountability must be maintained for all cash, real and personal property, and other assets. Grantee must adequately safeguard all such property and must provide assurance that it is used solely for authorized purposes. Grantee must also have systems in place that provide reasonable assurance that the information is accurate, allowable, and compliant with the terms and conditions of this Agreement. 2 CFR 200.303.

  • Internal Audit (1) Within ninety (90) days, the Board shall adopt, implement, and thereafter ensure Bank adherence to an independent, internal audit program sufficient to: (a) detect irregularities in the Bank's operations; (b) determine the Bank's level of compliance with all applicable laws, rules and regulations; (c) evaluate the Bank's adherence to established policies and procedures, with particular emphasis directed to the Bank's adherence to its loan policies concerning underwriting standards and problem loan identification and classification; (d) ensure adequate audit coverage in all areas; and (e) establish an annual audit plan using a risk based approach sufficient to achieve these objectives. (2) As part of this audit program, the Board shall evaluate the audit reports of any party providing services to the Bank, and shall assess the impact on the Bank of any audit deficiencies cited in such reports. (3) The Board shall ensure that the Bank has processes, personnel, and control systems to ensure implementation of and adherence to the program developed pursuant to this Article. (4) The Board shall ensure that the audit function is supported by an adequately staffed department or outside firm, with respect to both the experience level and number of the individuals employed. (5) The Board shall ensure that the audit program is independent. The persons responsible for implementing the internal audit program described above shall report directly to the Board, that shall have the sole power to direct their activities. All reports prepared by the audit staff shall be filed directly with the Board and not through any intervening party. (6) All audit reports shall be in writing. The Board shall ensure that immediate actions are undertaken to remedy deficiencies cited in audit reports, and that auditors maintain a written record describing those actions. (7) The audit staff shall have access to any records necessary for the proper conduct of its activities. National bank examiners shall have access to all reports and work papers of the audit staff and any other parties working on its behalf. (8) Upon adoption, a copy of the internal audit program shall be promptly submitted to the Assistant Deputy Comptroller.

  • Cooperation with Economic Studies If ICANN initiates or commissions an economic study on the impact or functioning of new generic top-­‐level domains on the Internet, the DNS or related matters, Registry Operator shall reasonably cooperate with such study, including by delivering to ICANN or its designee conducting such study all data related to the operation of the TLD reasonably necessary for the purposes of such study requested by ICANN or its designee, provided, that Registry Operator may withhold (a) any internal analyses or evaluations prepared by Registry Operator with respect to such data and (b) any data to the extent that the delivery of such data would be in violation of applicable law. Any data delivered to ICANN or its designee pursuant to this Section 2.15 that is appropriately marked as confidential (as required by Section 7.15) shall be treated as Confidential Information of Registry Operator in accordance with Section 7.15, provided that, if ICANN aggregates and makes anonymous such data, ICANN or its designee may disclose such data to any third party. Following completion of an economic study for which Registry Operator has provided data, ICANN will destroy all data provided by Registry Operator that has not been aggregated and made anonymous.

  • Budget Consulting Engineer/Architect shall advise City if, in its opinion, the amount budgeted for construction is not sufficient to adequately design and construct the improvement as requested.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • Internal Practices To make Business Associate’s internal practices, books and records relating to the use and disclosure of PHI received from County, or created or received by Business Associate on behalf of County, available to County or to the Secretary of the U.S. Department of Health and Human Services in a time and manner designated by County or by the Secretary, for purposes of determining County compliance with the HIPAA regulations.

  • Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to the Company’s principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to perform the functions for which they were established. Since the end of the Company’s most recent audited fiscal year, there have been no significant deficiencies or material weakness in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any change in its internal control over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

  • Internal Control Over Financial Reporting The Company and each of its Subsidiaries maintain a system of internal control over financial reporting (as such term is defined in Rule 13a-15(f) of the Exchange Act Regulations) that complies with the requirements of the Exchange Act and the Exchange Act Regulations and has been designed by the Company’s principal executive officer and principal financial officer and is sufficient to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including that (A) transactions are executed in accordance with management’s general or specific authorizations; (B) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (C) access to assets is permitted only in accordance with management’s general or specific authorization; (D) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and (E) the interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement is accurate and fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto. The systems of internal control over financial reporting of the Company and its Subsidiaries are overseen by the Audit Committee of the Board of Directors of the Company in accordance with Nasdaq rules and regulations. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, since the end of the Company’s most recent audited fiscal year, (i) there has been no material weakness in the Company’s internal control over financial reporting (whether or not remediated), (ii) there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting and (iii) the Company has not been advised of (a) any significant deficiencies in the design or operation of internal controls that could adversely affect the ability of the Company or any Subsidiary to record, process, summarize and report financial data, or any material weakness in internal controls, or (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the internal controls of the Company and each of the Subsidiaries.

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