Review of Lead Regulatory Party Appointments Sample Clauses

Review of Lead Regulatory Party Appointments. At least six (6) months prior to the planned submission of the first Registration Filing for each Product in each Co-Commercialization Country, the Joint Steering Committee shall review the appointment of the Lead Regulatory Party for each Co-Commercialization Country. In conducting such review, the Joint Steering Committee evaluation shall be based upon the following factors: (i) the most expeditious route to Regulatory Approval with the desired labeling for the relevant Product in the relevant country; and (ii) each Party's ability to certify that it is not presently subject to, and does not reasonably anticipate becoming subject to, an FDA mandated application integrity program or other equivalent form of regulatory review that would adversely affect such Party's ability to obtain Regulatory Approval in the country in an expeditious manner. At that time, the Joint Steering Committee shall have the right to modify the Lead Regulatory Party appointment based upon such evaluation. In addition, if the Lead Regulatory Party in a Co-Commercialization Country is different from the Lead Commercialization Party in such country, then, following Regulatory Approval for the relevant Product in such country, the Joint Steering Committee may appoint a Party as both the Lead Regulatory Party and the Lead Commercialization Party so that there is one lead party for all purposes in that country; provided, however, that Idenix' right to record sales in the U.S. Territory may be abridged only if Idenix has provided its prior written consent thereto or if the Joint Steering Committee has made such a decision in which Idenix concurred.
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Review of Lead Regulatory Party Appointments. Section 4.7 (g) is deleted.
Sample 1

Related to Review of Lead Regulatory Party Appointments

  • Initial Appointments The Company appoints the Trustee as the initial Paying Agent, the initial Registrar and the initial Conversion Agent.

  • Exclusive Appointment The Company acknowledges that the appointment of the Manager hereunder is an exclusive appointment for the Term. The Company shall not appoint other managers with respect to the Vessels or the Containership business during the Term, except in circumstances in which it is necessary to do so in order to comply with Applicable Laws or as otherwise agreed by the Manager in writing. This Section 2.5 does not prohibit the Company from having its own employees perform the Management Services.

  • Appointment of USBFS as Fund Accountant The Trust hereby appoints USBFS as fund accountant of the Trust on the terms and conditions set forth in this Agreement, and USBFS hereby accepts such appointment and agrees to perform the services and duties set forth in this Agreement. The services and duties of USBFS shall be confined to those matters expressly set forth herein, and no implied duties are assumed by or may be asserted against USBFS hereunder.

  • Appointment of Subservicer or Subcontractor (a) The Servicer may at any time appoint a subservicer to perform all or any portion of its obligations as Servicer hereunder if the Administrator and the Indenture Trustee has received ten (10) days prior written notice of the Servicer’s intention to do so and such appointment has satisfied the Rating Agency Condition; provided, however, that the Servicer shall remain obligated and be liable to the Issuer, the Owner Trustee, the Delaware Trustee, the Indenture Trustee, the Certificateholders and the Noteholders for the servicing and administering of the Receivables in accordance with the provisions hereof without diminution of such obligation and liability by virtue of the appointment of such subservicer and to the same extent and under the same terms and conditions as if the Servicer alone were servicing and administering the Receivables. The fees and expenses of the subservicer shall be as agreed between the Servicer and its subservicer from time to time, and none of the Issuer, the Owner Trustee, the Delaware Trustee, the Indenture Trustee, the Certificateholders or the Noteholders shall have any responsibility therefor.

  • Appointment of Servicer; Acceptance of Appointment Subject to Section 6.05 and Article VII, the Issuer hereby appoints the Servicer, and the Servicer, as an independent contractor, hereby accepts such appointment, to perform the Servicer’s obligations pursuant to this Agreement on behalf of and for the benefit of the Issuer or any assignee thereof in accordance with the terms of this Agreement and applicable law. This appointment and the Servicer’s acceptance thereof may not be revoked except in accordance with the express terms of this Agreement.

  • Appointment of Repo Custodian Upon the terms and conditions set forth in this Agreement, Repo Custodian is hereby appointed by the Funds to act as the custodian for the Participating Funds to hold cash, Cash Collateral and Securities for the purpose of effecting repurchase transactions for the Participating Funds through the Joint Trading Account pursuant to the Master Agreement. Repo Custodian hereby acknowledges the terms of the Master Agreement between the Funds and Seller (attached as an Exhibit hereto), as amended from time to time, and agrees to abide by the provisions thereof to the extent such provisions relate to the responsibilities and operations of Repo Custodian hereunder.

  • Restrictions on chartering, appointment of managers etc No Borrower shall, in relation to the Ship owned by it:

  • Delegation of Board Review of Subcustodians From time to time, the Custodian may agree to perform certain reviews of Subcustodians and of Subcustodian Contracts as delegate of the Fund's Board. In such event, the Custodian's duties and obligations with respect to this delegated review will be performed in accordance with the terms of the attached 17f-5 Delegation Schedule to this Agreement.

  • Board Appointment (a) Following the Closing and upon the written request of Castle Creek, the Company will promptly cause a person designated by Castle Creek, who shall be reasonably acceptable to the Company (provided that all managing principals and principals of Castle Creek shall be deemed reasonably acceptable to the Company for purposes hereof) (the “Board Representative”), to be elected or appointed to the Board of Directors of the Company (the “Board of Directors”), subject to satisfaction of all legal and regulatory requirements regarding service and election or appointment as a director of the Company, and Riverview Bank (the “Bank”) board of directors (the “Bank Board”), subject to all legal and regulatory requirements regarding service and election or appointment as a director of the Bank, and subject to compliance with all corporate governance guidelines or principles that the Corporation may adopt, to its code of conduct and to its xxxxxxx xxxxxxx and other policies applicable to members of the Board of Directors and the Bank Board, in each case for as long as Castle Creek, together with its Affiliates, owns the greater of: (i) in the aggregate, 50% or more of all of the Shares purchased pursuant to the Purchase Agreement (“Qualifying Ownership Interest”) or (ii) in the aggregate, 5% of the Common Stock, Series A Preferred Stock and Non-Voting Common Stock, taken as a whole, then outstanding (“Minimum Ownership Interest”). Notwithstanding anything to the contrary herein, in no event shall any failure to meet any applicable residency requirement be a valid reason for withholding approval of the Board Representative (or any replacement Board Representative) by the Board, the Bank Board or the Company, as the case may be. So long as Castle Creek, together with its Affiliates, has a Minimum Ownership Interest, the Company will recommend to its shareholders the election of the Board Representative to the Board of Directors at the Company’s annual meeting of shareholders, subject to satisfaction of all legal requirements regarding service and election or appointment as a director of the Company. If Castle Creek no longer has a Minimum Ownership Interest, Castle Creek will have no further rights under Sections 1(a) through 1(b) and, at the written request of the Board of Directors, shall use all reasonable best efforts to cause its Board Representative to resign from the Board of Directors and the Bank Board as promptly as possible thereafter. Castle Creek shall promptly inform the Company if and when it ceases to hold a Minimum Ownership Interest in the Company.

  • Responsibility for Subcustodians Except as provided in the last sentence of this Section 8.6, the Custodian shall be liable to the Fund for any loss or damage to the Fund caused by or resulting from the acts or omissions of any Subcustodian to the extent that such acts or omissions would be deemed to be negligence, gross negligence or willful misconduct in accordance with the terms of the relevant subcustodian agreement under the laws, circumstances and practices prevailing in the place where the act or omission occurred. The liability of the Custodian in respect of the countries and Subcustodians designated by the Custodian, from time to time on the Global Custody Network Listing shall be subject to the additional condition that the Custodian actually recovers such loss or damage from the Subcustodian.

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