DILIGENCE OBLIGATIONS, REGULATORY RESPONSIBILITIES AND RECALLS Sample Clauses

DILIGENCE OBLIGATIONS, REGULATORY RESPONSIBILITIES AND RECALLS. 3.1 Regulatory Diligence Obligations SEPRACOR will employ commercially reasonable efforts to file and obtain approval of a Marketing Authorization Application for Product in the United States. Such efforts shall include efforts to proactively pursue approval as well as to respond with reasonable diligence to any requests for information or other assistance from the FDA which are necessary to obtain such approval. To the extent that any information requested by FDA concerning the manufacture of Product post-approval is in the possession of 3M and not SEPRACOR, 3M will respond with reasonable diligence to such requests and provide other assistance as may be needed on a timely basis (consistent with an annual Product review and NDA annual report as is established for the Product, it being understood by the Parties that the due dates for any such annual review and/or report are typically based on the FDA approval date for the Product) to assist SEPRACOR in maintaining an FDA-compliant NDA post-approval.
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Related to DILIGENCE OBLIGATIONS, REGULATORY RESPONSIBILITIES AND RECALLS

  • 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.

  • Client Responsibilities During the Term and subject to the provisions of this Schedule, Client shall at its expense (unless otherwise provided for herein) fulfill, or cause to be fulfilled by the Funds or otherwise, the Client obligations, if any, set forth in each Service Exhibit to this Schedule. Client hereby represents, warrants and covenants that the execution and delivery of this Schedule by Client and the performance of Client’s obligations under this Schedule have been duly authorized by all necessary action on the part of Client. Client must comply with the provisions of this Schedule. Client agrees that DST may seek relief from Client for any infringement of this Schedule such as, but not limited to, a material violation, breach, act of negligence or gross negligence, willful misconduct, misfeasance or malfeasance committed by Client or its officers, agents and assigns, in connection with Client’s obligations and responsibilities under this Schedule.

  • Contractor Responsibilities It shall be Tenant’s responsibility to cause each of Tenant’s contractors and subcontractors to:

  • Regulatory Responsibility (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities.

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Additional Responsibilities The Sub-Advisor may, but shall not be under any duty to, perform services on behalf of the Fund which are not required by this Agreement upon the request of the Fund's Board of Directors. Such services will be performed on behalf of the Fund and the Sub-Advisor's charges in rendering such services will be billed monthly to the Fund, subject to examination by the Fund's independent certified public accountants. Payment or assumption by the Sub-Advisor of any Fund expense that the Sub-Advisor is not required to pay or assume under this Agreement shall not relieve the Sub-Advisor of any of its obligations to the Fund nor obligate the Sub-Advisor to pay or assume any similar Fund expenses on any subsequent occasions.

  • Custodial Responsibilities ARTICLE IX

  • Joint Responsibilities In performing the Development Efforts, each party shall

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

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