EU Approval definition

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.

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.

Examples of EU Approval in a sentence

• 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.

• Collectively, this option is referred to herein as the “EU Approval Option.” The EU Approval Option is not available for Digital Content.

• 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.

• Collectively, this option is referred to herein as the “EU Approval Option.” The EU Approval Option is not available for Online Features 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.

More Definitions of EU Approval

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

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

EU Approval means the first receipt of all Regulatory Approvals (including pricing approvals) required to sell the Product in [*] of the countries in the Major Markets.

EU Approval means (a) receipt of Regulatory Approval of a Licensed Product in the European Union by the Centralized Procedure or in at least one of the Major European Countries and (b) first receipt of Pricing Approval for such Licensed Product in at least one of the Major European 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). EUR or € means the currency of the member states of the European Union that adopted the euro as their currency pursuant to EU legislation on monetary union.

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.