Filing for Regulatory Approval definition

Filing for Regulatory Approval means (i) in the case of [*], the date on which [*] in relation to the applicable Alliance Product [*]; (ii) in the case of [*], the earlier of (aa) the date on which the appropriate regulatory authorities in [*] for the applicable Alliance Product filed by or on behalf of GSK in such Country or (bb) the date on which [*] or any successor thereto [*] for the applicable Alliance Product filed by or on behalf of GSK; and (iii) in the case of [*], the date on which the relevant governmental authority in [*] for the applicable Alliance Product filed by or on behalf of GSK in [*].
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Filing for Regulatory Approval shall have the meaning set forth in Section 6.2.2.
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Filing for Regulatory Approval means the filing or submission of (a) an MAA with the FDA as defined in the FD&C Act and applicable regulations, or (b) an equivalent MAA with the equivalent agency in any other country or group of countries, the official approval of which application is required before any lawful commercial sale or marketing of Licensed Products in the applicable country is permitted.
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Examples of Filing for Regulatory Approval in a sentence

  • Initiation of [***] [***] Filing for Regulatory Approval and Launch milestones as per Section 6.2.2 of the Agreement Notwithstanding the definition of the term “Alliance Product” in the Agreement, “Alliance Product” shall include the Supplemental MABA Alliance Products in the definitions specified in Section 6.2.2, and all of the definitions set forth in Section 6.2.2 shall apply to the Supplemental MABA Alliance Products.

  • The other Party shall have the right (but not the obligation) (the “Supplemental Study Opt-In Right”) to access any study reports and data of such Supplemental Study(ies) that such other Party did not co-fund for purposes of Filing for Regulatory Approval in such other Party’s Territory by paying […***…] of the Development Costs incurred by the Party conducting such Supplemental Study.

  • The JCC shall conduct its first meeting in the first full Calendar Quarter that occurs after the submission of the first Regulatory Filing for Regulatory Approval in the Field in the Territory, and shall meet each Calendar Quarter thereafter until the [*****] full Calendar Quarter after the first Regulatory Approval and Pricing Approval for a Product in the Field in the Territory are obtained.

  • REGULATORY APPROVAL 25 8.1 Receipt of Regulatory Approval 25 8.2 Filing for Regulatory Approval 25 8.3 Failure to Obtain Regulatory Approval 25 9.