EU Regulatory Approval definition

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

Examples of EU Regulatory Approval in a sentence

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.

Prior to the Effective Date, Spark has independently initiated ongoing clinical studies in the United States of Luxturna to support Spark’s efforts to obtain EU Regulatory Approval and Regulatory Approval in the Spark Territory (collectively, the “Existing Luxturna Clinical Program”).

The following three items (x), (y) and (z) may be discussed at meetings of the JSC, but, in the event that the JSC is unable to resolve any such issue to the satisfaction of the Parties within [**], such issue shall be treated as a dispute and either Party may evoke the dispute resolution procedures set forth in ARTICLE 11.(x) Issues arising with respect to obtaining the EU Regulatory Approval and the Parties’ obligations pursuant to Section 4.4.1(a).

Any responsibility of ASTELLAS for the preparation of the Common Technical Document or any MAA does not, pursuant to this Agreement or otherwise, guarantee that EU Regulatory Approval will be obtained.

From the Effective Date up until two years following the first EU Regulatory Approval of a Product, either Party may, upon written notice to the other Party, unilaterally terminate this Agreement if the Parties are prevented in any manner that materially adversely affects the progression of the Development or Commercialization of Product(s) as contemplated in this Agreement for a period of six (6) months or more as a result of any Government Order based on antitrust or competition Law grounds.


More Definitions of EU Regulatory Approval

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 [*].
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 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 receipt of MAA approval and Pricing Approval from [***].
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 (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. CONFIDENTIAL TREATMENT REQUESTED
EU Regulatory Approval means (a) marketing authorization approval from the EMEA and pricing and reimbursement approval in any three of France, Germany, Italy, Spain or the United Kingdom or (b) national marketing authorization approval and pricing and reimbursement approval in any three of France, Germany, Italy, Spain or the United Kingdom.