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 (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.

Examples of EU Regulatory Approval in a sentence

• 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.

• 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.

• 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.

• The cost to obtain and maintain all necessary regulatory filings and Regulatory Approvals for Products will be borne by Novartis in the Novartis Territory and by Ophthotech in the Ophthotech Territory, with the exception of the filing fees for obtaining EU Regulatory Approval of the Standalone Product pursuant to the Existing Fovista Clinical Program, which shall be borne by Ophthotech.

• Subject to Section 2.1.3, Spark shall use commercially reasonable efforts to obtain EU Regulatory Approval.

More Definitions of EU Regulatory Approval

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

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) 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, [**]. 1.90 “Excluded Assets” has the meaning set forth in the definition of Control. 1.91 “Excluded Compound” has the meaning set forth in the definition of Related Compound.

EU Regulatory Approval means the Regulatory Approval by the EMA for the Product with a regulatory label that allows the use of the Product for the primary treatment of invasive aspergillosis and mucormycosis, including in renally impaired patients.