Initial Regulatory Approval definition
Initial Regulatory Approval of the Licensed Product for an indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to the Licensed Product for such indication in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized approval procedure, if applicable, or otherwise with respect to the mutual recognition approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe).
Initial Regulatory Approval means the first authorization or approval of Drug Approval Applications for marketing or commercial sale of Product for Crohn’s disease in Europe and in the United States by the European Commission and the FDA, respectively.
Initial Regulatory Approval means the first approvals, licenses, registrations, CE Marking or authorizations of any national, supra-national (e.g., the FDA, the EMEA or Koseisho), state or local regulatory agency, department, bureau, commission, council or other governmental entity, sufficient for the manufacture, distribution, use and sale of Licensed Product in a regulatory jurisdiction in accordance with applicable laws, excluding receipt of pricing and reimbursement approvals.
Examples of Initial Regulatory Approval in a sentence
Subject to Section 6.5(c), during the period commencing on the Amendment Effective Date and ending on the earlier of (a) the Termination Date, and (b) the [***] ([***]) anniversary of the Initial Regulatory Approval Date, neither Q-Med nor NSH, nor any of their Affiliates, shall, directly or indirectly, Commercialize in the Licensed Field in the Territory any Competitive Product.
Each party will be responsible for ensuring that its respective responsibilities concerning studies performed under the Collaborative Activities are performed in compliance with applicable GMP, GLP and GCP requirements and all regulatory requirements for the filing and prosecution of the Initial Regulatory Approval and subsequent approvals.
No later than twelve (12) months prior to the expected date of the Initial Regulatory Approval of the Licensed Product in Japan, Yakult shall prepare for review and comment by the SC a proposed Commercialization Plan for the Licensed Product from the date of launch through the third anniversary of April 1 of the Calendar Year in which the Initial Regulatory Approval is expected to be achieved.
Initial Regulatory Approval for the first Additional Indication in Japan [***] Japanese Yen (JPY [***]) *** Confidential treatment requested.
Thereafter, Yakult shall, on or before January 31 of each Calendar Year, provide to the SC for its review and comment proposed amendments to the Commercialization Plan, which, after the first anniversary of April 1 of the Calendar Year in which the Initial Regulatory Approval for the Licensed Product is achieved in Japan, shall include the Commercialization Plan for the Calendar Year commencing on the third anniversary of January 1 of the then-current Calendar Year.
More Definitions of Initial Regulatory Approval
Initial Regulatory Approval means activation by the FDA of Orphan's IND submission covering the Drug-System Combination.
Initial Regulatory Approval of a Licensed Product for an Indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory outside the United States, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to a Licensed Product for an Indication in the applicable regulatory jurisdiction (including, in Europe, the approval by the European Commission of an MAA filed pursuant to the centralized approval procedure. 1.1.69 “Intellectual Property Rights” shall mean Trademarks, service marks, trade names, registered designs, design rights, copyrights (including rights in computer software), database rights, trade secrets and any rights or property similar to any of the foregoing (other than Patents) in any part of the world whether registered or not registered together with the right to apply for the registration of any such rights. 1.1.70 “Invoiced Sales” shall have the meaning set forth in Section 1.1.100. 1.1.71 “Joint Improvement” shall mean any Improvement jointly conceived by or on behalf of Licensor or its Affiliates, on the one hand, and Licensee or its Affiliates or Sublicensees, on the other hand. 1.1.72 “Joint Intellectual Property Rights” shall have the meaning set forth in Section 8.1.5. 1.1.73 “Joint Know-How” shall have the meaning set forth in Section 8.1.5. 1.1.74 “Joint Patents” shall have the meaning set forth in Section 8.1.5. 1.1.75 “Joint Steering Committee” or “JSC” shall have the meaning set forth in Section 6.1.1. 1.1.76 “Know-How” shall mean the Licensor Know-How, the Licensee Know-How and the Joint Know-How. 1.1.77 “Knowledge” shall mean the actual knowledge or good faith understanding of the vice presidents, senior vice presidents, president or chief executive officer of a Party of the facts and information then in their possession without any duty to conduct any investigation with respect to such facts and information and “Knowingly” shall mean, with respect to any action, to take such action with Knowledge. 1.1.78 “Licensed Compound” shall mean CP-4126 and any analog or derivative of CP-4126 developed by Licensor. 1.1.79 “Licensed Product” shall mean any oral and intravenous formulations of the Licensed Compound existing as of the Original Execution Date, and any formulations developed thereafter by or for Licensor or Licensee, and any other ...
Initial Regulatory Approval of a Licensed Product for an Indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory outside the United States, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to a Licensed Product for an Indication in the applicable regulatory jurisdiction (including, in Europe, the approval by the European Commission of an MAA filed pursuant to the centralized approval procedure.
Initial Regulatory Approval of a Licensed Product for an indication means (a) with respect to the United States, the approval by the FDA and, (b) with respect to a country or jurisdiction other than the United States, the approval by the applicable Regulatory Authorities of the Drug Approval Application with respect to such Licensed Product for such indication in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized Approval procedure, if applicable, or otherwise with respect to the mutual recognition Approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe).
Initial Regulatory Approval of the Licensed Product for an indication shall mean (a) with respect to the United States, the first approval by FDA or (b) with respect to Japan, the first marketing approval by MHLW, of the Drug Approval Application with respect to the Licensed Product for such indication.
Initial Regulatory Approval of a Product means (a) with respect to the United States, the approval by FDA (whether through means of a BLA, subpart E, or subpart H filing or otherwise); and (b) with respect to a country in a regulatory jurisdiction in the Royalty Territory, the approval by the applicable Regulatory Authorities of the Drug Approval Application with respect to such Product in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized Approval procedure, if applicable, or otherwise with respect to the mutual recognition Approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe). If “Initial Regulatory Approval” is used with respect to a particular Product (i) without reference to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody, either as the sole active ingredient, or for use in combination with one or more Agents, irrespective of the Indication and (ii) with respect to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody for such Indication, either as the sole active ingredient or for use in combination with one or more Agents. Unless an Initial Regulatory Approval for a Product is expressly stated to be for an Indication, it shall be deemed to relate to the applicable Product generally, as reflected by the example set forth in clause (i) above, and not to a specific Indication.
Initial Regulatory Approval is used with respect to a particular Product (i) without reference to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody, either as the sole active ingredient, or for use in combination with one or more Agents, irrespective of the Indication and (ii) with respect to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody for such Indication, either as the sole active ingredient or for use in combination with one or more Agents. Unless an Initial Regulatory Approval for a Product is expressly stated to be for an Indication, it shall be deemed to relate to the applicable Product generally, as reflected by the example set forth in clause (i) above, and not to a specific Indication.