Transfer of Sponsorship of Existing INDs Clause Samples

Transfer of Sponsorship of Existing INDs. (a) Within [***] days after the later of (i) the execution of the Pharmacovigilance Agreement, (ii) the Completion of the Ongoing Trial, and
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Transfer of Sponsorship of Existing INDs. (a) Within [***] days after the later of (i) the execution of the Pharmacovigilance Agreement, (ii) the Completion of the Ongoing Trial, and (iii) completion of the Safety Database Transfer, Novartis and its Affiliates shall assign and transfer to Pharming the sponsorship of the Existing INDs and the other Regulatory Filings identified on Exhibit E (the “Transferred Regulatory Filings”) and any other Regulatory Documentation (if applicable), in each case, in accordance with the Transition Plan. If Novartis is restricted under Applicable Law from transferring ownership of any Transferred Regulatory Filing or Regulatory Documentation, Novartis will grant, and hereby does grant, to Pharming (or its designee) a right of reference to use to such Transferred Regulatory Filing or Regulatory Documentation in accordance with Applicable Law. Novartis will use Commercially Reasonable Efforts to take such actions as are reasonably necessary to effect such transfer or grant of right of reference or use to Pharming or its designee; (b) To effect the transfer described in Section 5.6(a), Novartis will file with relevant Regulatory Authorities a notification that the sponsorship of the Transferred Regulatory Filings is being transferred from Novartis to Pharming, and Pharming will submit to the relevant Regulatory Authorities a notification that it is assuming the sponsorship of the Transferred Regulatory Filings. These notifications shall be filed simultaneously by the Parties unless otherwise required by Applicable Law. Thereafter, Pharming shall have sole responsibility to maintain the Existing INDs and any other IND related to the Licensed Compound or Licensed Products, and shall be responsible for all future communications with the relevant Regulatory Authorities regarding the Transferred Regulatory Filings and any and all subsequent Regulatory Filings relating to the Licensed Compound or Licensed Products under the Transferred Regulatory Filings or otherwise. If, at any time after the Transferred Regulatory Filings are transferred to Pharming, a Regulatory Authority requests information, data, or documentation Controlled by Novartis or its Affiliates, Novartis will provide such information, data, or documentation, to the extent that such information, data and documentation is accessible by Novartis using Commercially Reasonable Efforts, and shall reasonably cooperate with Pharming with respect to responding to requests from Regulatory Authorities. (c) Without limiti...
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Related to Transfer of Sponsorship of Existing INDs

  • Ratification of Existing Agreements All existing Dual Enrollment agreements between the TRUSTEES and the Private School are hereby modified to conform to the terms of this agreement and the appendices of this document.

  • Termination of Existing Agreements Any previous employment agreement between Executive on the one hand and Employer or any of Employer’s Affiliates (as hereinafter defined) on the other hand is hereby terminated.

  • Transfer of Licenses Lessee shall use reasonable efforts (i) to transfer to Lessor or Lessor’s nominee all licenses, operating permits and other governmental authorizations and all contracts, including contracts with governmental or quasi-governmental entities, that may be necessary for the operation of the Hotel (collectively, “Licenses”), or (ii) if such transfer is prohibited by law or Lessor otherwise elects, to cooperate with Lessor or Lessor’s nominee in connection with the processing by Lessor or Lessor’s nominee of any applications for, all Licenses; provided, in either case, that the costs and expenses of any such transfer or the processing of any such application shall be paid by Lessor or Lessor’s nominee.

  • Transfer of Agreement Without prior written consent of the WFOE, the Existing Shareholders or the Domestic Company may not assign its rights and obligations hereunder to any third party.

  • Merger of Agreement This Agreement constitutes the entire agreement between the parties hereto and supersedes any prior agreement with respect to the subject matter hereof whether oral or written.