EU Approval definition

EU Approval means (a) first achievement of Regulatory Approval of a Product in the European Union by the centralized procedure or in at least [*] Major European Countries; and (b) first receipt of Pricing Approval for such Product in at least [*] Major European Countries.

EU Approval has the meaning set forth in Section 6.3(b).

EU Approval means the later of (i) first achievement of MAA approval in the European Union by the centralized procedure or in at least three of the five Major European Countries; and (b) first receipt of Pricing Approval in at least three Major European Countries, provided that Jazz uses Commercially Reasonable Efforts to obtain such Pricing Approvals after the corresponding MAA approval.

Examples of EU Approval in a sentence

• Unless Publisher elects the EU Approval Option for a European FPU (described below), Publisher is required to submit its Software Title to Microsoft for evaluation at all four phases.

• This option is referred to herein as the “EU Approval Option.” The EU Approval Option applies solely to distribution of European FPUs, and is not available for Online Content intended to be available in the European Sales Territory.

• Notwithstanding Publisher’s choice of the EU Approval Option, all other portions of this Agreement other than those specifically identified above shall remain in effect.

• If Publisher chooses the EU Approval Option, Publisher shall not use the Licensed Trademarks on the European FPU and the license grant set forth in Section 12.1 is withdrawn as to such European FPU.

• Notwithstanding EA’s choice of the EU Approval Option, all other portions of the Agreement other than those specifically identified above shall remain in effect.

More Definitions of EU Approval

EU Approval means the approval of the European Medicines Evaluation Agency.

EU Approval means Marketing Authorization in at least [**] of the Major EU Market Countries.

EU Approval means the decision or deemed decision by the European Commission pursuant to Articles 4(2), 4(3), 4(6) or Article 7(2) to 7(4) of the Implementing Regulation. EU Interest Communication means the Commission notice on current state aid recovery interest rates and reference/discount rates for 28 Member States applicable as from 1 May 2015 (2015/C 143/08).

EU Approval means (a) regulatory approval in the EU through the central procedure plus regulatory approval (including receipt of pricing approval) in any [***] EU Major Market Country

EU Approval means the approval, consent or clearance of the European Commission pursuant to Council Regulation (EEC) No. 4064/89, as amended.

EU Approval means receipt by Schering or its Affiliate or sublicensee of the EU Commission’s written decision granting Approval for the marketing and sale of the Product in the Field in the EU, or in the case of Approvals granted pursuant to the de-centralized procedure, the written decisions of all Major EU Member States granting Approval for the marketing and sale of the Product in the Field in their respective regulatory jurisdictions.

EU Approval. ’ means the approvals described under ‘‘Part C — European Union’’ in Schedule ‘‘C’’ to the Arrangement Agreement;