EU Regulatory Approval definition

EU Regulatory Approval means Regulatory Approval [******] of a Licensed Product by EMA or the relevant Regulatory Authority in [******] of the Major European Markets.

EU Regulatory Approval means achievement of both: (a) receipt of written notice from EMA of approval by EMA of an MAA submitted by Gilead, its Affiliates, or its sublicensees for a Licensed Product; and (b) either (i) receipt of written notice from the applicable Regulatory Authorities of Pricing Approval for such Licensed Product in [***] EU Major Market Countries, or (ii) First Commercial Sale (disregarding any requirements for Pricing Approvals) of such Licensed Product in [***] EU Major Market Countries.

EU Regulatory Approval means the first approval of an MAA for a Licensed Product in the EU.

Examples of EU Regulatory Approval in a sentence

• Such EU Regulatory Approval Payments shall be paid by Licensee to Coherus within fifteen (15) days of the occurrence of the applicable event by wire transfer of immediately available funds into an account designated in writing by Coherus.

• If Coherus and Licensee are unable to resolve any Licensee comments within such thirty (30)-day period, any delay involved in the filing beyond the initial thirty (30)-day period shall be credited to Coherus, on a day-for-day basis, in determining the order of entrance to market for the EU Regulatory Approval Milestone.

• The cost to obtain and maintain all necessary regulatory filings and Regulatory Approvals for Luxturna will be borne by [**], with the exception of the filing fees and all other costs related to obtaining the EU Regulatory Approval of Luxturna, including any activities required by Sections 4.4.1(a)(ii)(1)(a) and 4.4.1(a)(ii)(2) (which costs shall be borne by [**]) but excluding any activities required by Section 4.4.1(a)(ii)(1)(b) (which costs shall be borne by [**]).

• In addition, subject to Section 4.4.2, if Novartis is required to conduct further Development of the Product for the EU following EU Regulatory Approval, including to satisfy Post-Approval Commitments to Regulatory Authorities, to seek label expansions or otherwise for product life cycle management purposes, Novartis shall provide to Spark a Development Plan for such activities.

• Millennium shall use commercially reasonable efforts to follow such advice and shall take all actions reasonably necessary to accomplish the EU Regulatory Approval Transfer on or as soon as possible after the Effective Date.

More Definitions of EU Regulatory Approval

EU Regulatory Approval means (a) marketing authorization approval from the EMEA and pricing and reimbursement approval in any three Major EU Countries or (b) national marketing authorization approval and pricing and reimbursement approval in any three Major EU Countries.

EU Regulatory Approval means (a) receipt of Regulatory Approval by the EMA through the Centralized Approval Procedure or (b) receipt of Regulatory Approval from the applicable Regulatory Authorities in [***] Major European Countries.

EU Regulatory Approval means the final approval to market the Developer Invention in any Member State of the EU, including pricing and reimbursement approval and any other approval which is required to launch the Developer Invention in the normal course of business.

EU Regulatory Approval means receipt of MAA approval and Pricing Approval from [***].

EU Regulatory Approval means (a) marketing authorization approval from the EMA and pricing and reimbursement approval [*] or (b) marketing authorization approval and pricing and reimbursement approval [*]. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

EU Regulatory Approval means an approval, license or authorization issued by the European Medicines Agency, or any successor agency, required for the commercial manufacture, marketing and sale of a Product in the European Union in accordance with applicable law.

EU Regulatory Approval means the final approval to market the Developer Invention in any Member State of the EU, including pricing and reimbursement approval and any other approval which is required to launch the Developer Invention in the normal course of business. “Field” shall mean all indications of any nature.