First Regulatory Approval definition

First Regulatory Approval means, in relation to each COVID Product, unless expressly stated otherwise in this Agreement, the earlier of (i) final marketing authorization for a COVID Product in any jurisdiction of the Territory, or (ii) the grant of any conditional authorization for a COVID Product in any jurisdiction of the Territory.

First Regulatory Approval means the first, of either CE marking certification or FDA approval, to be received by Oxford for the labelling, distribution and sale of the Product for use in the Field.

First Regulatory Approval means, [***].

Examples of First Regulatory Approval in a sentence

• First Regulatory Approval in the United States of an SMA Licensed Product $ [***] (ii) First occurrence of both (a) Regulatory Approval by the $ [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

• In the event that Oxford has not obtained First Regulatory Approval prior to the third Agreement Anniversary Date (i.e. in 2011), Oxford will immediately commence making Exclusivity Payments to StemCell, as described in Subsection 3.1.3, on the third Agreement Anniversary Date, as if it had obtained such First Regulatory Approval.

• First Regulatory Approval of a Collaboration Compound by Gilead or a Related Gilead Party shall be deemed a selection by Gilead of such Collaboration Compound as a Selected Compound.

• Prior to the First Regulatory Approval of the Product, the Parties shall amend the existing pharmacovigilance agreement or enter into a new pharmacovigilance agreement to address the Commercialization and other activities with respect to the Product contemplated by this Agreement.

• The incremental portion of the Parties’ costs and expenses incurred in maintaining the databases described in Section 9.2 attributable to the Joint Products and the Parties’ costs and expenses incurred in conducting audits pursuant to a Pharmacovigilance Agreement shall be deemed to be Joint Development Costs, or following First Regulatory Approval of the applicable Joint Product, Allowable Expenses, in each case, to the extent falling within and in accordance with, the definitions thereof.

More Definitions of First Regulatory Approval

First Regulatory Approval means the first regulatory approval of a Licensed Product by a regulatory authority in [*].

First Regulatory Approval means authorisation for marketing a Product by the United States Food and Drug Administration or by the governing health authority in any other country or region.

First Regulatory Approval means the first Regulatory Approval of an HTG Assay by a Regulatory Authority. For the sake of clarity, the First Regulatory Approval does not include a subsequent approval in a different country of the same HTG Assay.

First Regulatory Approval means, in relation to each Product, the obtaining of a final marketing authorization for a Product in any jurisdiction in the Territory.

First Regulatory Approval means with respect to a Joint Product, on an indication-by-indication basis, the date on which the Lead Party has obtained all Regulatory Approvals in the United States and the European Union for such Product for such indication.

First Regulatory Approval means Regulatory Approval granted by the FDA or a Regulatory Approval granted by an appropriate Regulatory Authority in a foreign country, whichever is earlier.

First Regulatory Approval means the first to occur of the HNC Regulatory Approval and the Melanoma Regulatory Approval.