Final Regulatory Approval definition

Final Regulatory Approval means, with respect to the United States or a jurisdiction within the Territory, receipt of all authorizations by the FDA or the appropriate Territorial Regulator or Regulators, as the case may be, necessary for commercial sale of the Product within such jurisdiction, including, without limitation, approval of manufacturing, labeling, price (if required) and treatment parameters.
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Final Regulatory Approval means in relation to any Licensed Product, the approval by the regulatory authority in a given country as may be required before such Licensed Product may be sold in such country.
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Final Regulatory Approval means Regulatory Approval that allows for the immediate marketing and sale of a Licensed Product.
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Examples of Final Regulatory Approval in a sentence

  • With respect to those countries outside the United States in which EpiCept has obtained Final Regulatory Approval of the LidoPAIN(R) BP Product.

  • Subject to Section 3.4 herein, Endo shall commercialize the LidoPAIN(R) BP Product in the United States within six (6) months from the date on which LidoPAIN(R) BP Product receives Final Regulatory Approval in the United States so long as EpiCept shall have supplied Endo with quantities of the LidoPAIN(R) BP Product sufficient to commercially launch the Product as set forth in Endo's committed forecast delivered pursuant to the Supply Agreement.

  • Fresenius GmbH shall have the right to obtain Final Regulatory Approval in all jurisdictions within the Non-U.S. Territory in its own name and, where required by applicable law, in the name of any permitted distributor or sublicensee of Fresenius GmbH, and shall own all such Final Regulatory Approvals as are issued and all submissions as are made in connection therewith.

  • After Final Regulatory Approval is obtained for the Lead Product [***] as provided in Section [***], ownership of the NDA and all other regulatory filings for the Lead Product in the Territory, will be assigned by POZEN to GSK at no additional charge to GSK.

  • The provisions of this Section I-6(d) shall remain in full force and effect even if Final Regulatory Approval of the Three Agreements is not obtained.

  • Within [* *] following NDA Approval for the Lead Product [* *], GSK will notify POZEN in writing of [* *], GSK will use Commercially Reasonable Efforts to initiate Commercial Launch of the Lead Product in the Territory as soon as commercially practicable after Final Regulatory Approval is granted, [* *] (excluding delays not within GSK’s control, if any, related to manufacturing issues or the requirements of the FDA), in accordance with the Product Launch Plan and Commercialization Plan.

  • After Final Regulatory Approval is obtained for the Lead Product [* *] as provided in Section [* *], ownership of the NDA and all other regulatory filings for the Lead Product in the Territory, will be assigned by POZEN to GSK at no additional charge to GSK.

  • The approved costs of obtaining Final Regulatory Approval in the Non-U.S. Territory shall be included in budgets for Research and Development and Clinical Trials Costs for the Non-U.S. Territory and shall be reimbursed to Fresenius AG out of Non-U.S. Cash Flow in accordance with the terms of this Agreement.

  • Endo shall, either through a Marketing Partner(s) or on its own, commercialize the LidoPAIN(R) BP Product in each such country within *** from the date on which LidoPAIN(R) BP receives Final Regulatory Approval in the United States.

  • Endo shall, either through a Marketing Partner(s) or on its own, commercialize the LidoPAIN(R) BP Product in each such country within three (3) years from the date on which LidoPAIN(R) BP receives Final Regulatory Approval in the United States.


More Definitions of Final Regulatory Approval

Final Regulatory Approval means the Regulatory Approval granted by a Governmental Authority after the successful completion of a Phase III Clinical Trial.
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Final Regulatory Approval means the approvals of this Agreement and the Renewable Resource procurement by the IPUC and OPUC pursuant to orders the terms of which are fully satisfactory to both Idaho Power and City of Boise.
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Final Regulatory Approval means that a Consent Judgment Compliance Letter was issued by NJDEP pursuant to the 2011 Consent Judgment for the specified contaminants, media and areas of concern identified in the letter . The Consent Judgment Compliance Letter is the Department’s equivalent of a No Further Action letter that is issued after all appropriate remediation documents have been finalized with respect to the applicable contaminants, media and areas of concern, an RAR Determination has been made, and after the issuance by the Department of any required remedial action permits. The Notes to the Master Schedule, Attachment 2 to this Report defines the term “RAR Determination.”
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