Lead Responsibility for Regulatory Interactions Sample Clauses

Lead Responsibility for Regulatory Interactions. Except as may otherwise be mutually agreed by the Parties or the JSC, JDC or JCC, as applicable, and subject to oversight by the JSC, JDC or JCC:
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Lead Responsibility for Regulatory Interactions. Except as may otherwise be mutually agreed by the Parties, and subject to oversight by the JSC: [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed
Lead Responsibility for Regulatory Interactions. Except as may otherwise be mutually agreed by the Parties:

Related to Lead Responsibility for Regulatory Interactions

  • Regulatory Responsibilities Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Reporting Responsibilities The IRA Owner agrees to provide the Custodian with information necessary for the Custodian to prepare any reports required under Code Sections 408(i), 408A(d)(3)(D), and Regulations Sections 1.408-5 and 1.408-6. The Custodian agrees to submit reports to the IRS and the IRA Owner (or Beneficiary(ies) upon the IRA Owner’s death) as prescribed by the IRS and such additional reports as the Custodian may choose to deliver. The Custodian shall furnish annual calendar-year reports concerning the status of the IRA and such information concerning required minimum distributions as is prescribed by the Commissioner of the IRS.

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • Joint Responsibilities 2.1.1 University and Affiliate each will identify, and notify each other of, a person responsible for serving as its liaison during the course of this affiliation. The appointment of liaisons shall be subject to mutual approval of the parties.

  • Client’s Responsibilities In addition to other responsibilities herein or imposed by law, the Client shall:

  • Responsibility for Content Vendor is solely responsible for administration, content, intellectual property rights, and all materials at Vendor’s website. DIR reserves the right to require a change of listed content if, in the opinion of DIR, it does not adequately represent the Contract.

  • District Responsibilities With respect to all sums deducted by the District pursuant to authorization of the employee, whether for membership dues or equivalent fees, the District agrees promptly to remit such monies to the Association together with an alphabetical list of unit members for who such deductions have been made, categorizing them as to membership or non-membership in the Association, and indicating any changes in personnel from the list previously furnished.

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to:

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

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