EMA Approval definition

EMA Approval means approval by the European Commission of a “marketing authorisation application” in the European Union, through the centralized procedure, for Dalbavancin, which authorization grants any Selling Entity the right to market and sell Dalbavancin in the European Union in accordance with applicable Law. For the avoidance of doubt, EMA Approval does not refer to approval in one or more individual countries of the European Union or to a positive opinion by EMA’s Committee for Medicinal Products for Human Use.
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EMA Approval means the decision of the European Commission addressed to Parent, any of its controlled Affiliates or any Assignee granting marketing authorization through the centralized procedure for the Product, following a positive opinion by the EMA, which authorization grants Parent, any of its controlled Affiliates or any Assignee the right to market and sell the Product immediately for use in the European Union for the treatment of opioid induced constipation on or before the Regulatory Approval Payment Target Date. For clarity, EMA Approval does not refer to approval in one or more individual Major Market countries of the European Union.
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EMA Approval means the receipt by Licensee, its Affiliate or Sublicensee of all Regulatory Approvals by the EMA required for the commercialization and marketing in the European Union of a Licensed Product.
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Examples of EMA Approval in a sentence

  • Unless the Parties agree otherwise in writing, Mundipharma shall be responsible for conducting all EMA Approval Additional Studies and the Parties shall share the costs of such studies as specified in Section 4.5.

  • If the EMA notifies either Party that any clinical studies, in addition to the studies included in the DAA filed by Allos and validated by the EMA on December 15, 2010, and the Existing Studies, are required to obtain, or are a condition of obtaining, Regulatory Approval of the Product by the EMA for the Lead Indication, then such studies will be deemed "EMA Approval Additional Studies" and promptly added to the Development Plan, by amendment in accordance with Section 4.2(c).

  • FDA Approval 5,000,000 [***] [***] [***] [***] [***] [***] [***] 0 330,000,000 EMA Approval 5,000,000 [***] [***] [***] [***] [***] [***] [***] 0 210,000,000 First Approval by either PMDA or NMPA 1,000,000 [***] [***] [***] [***] [***] [***] [***] [***] 60,000,000 Total 11,000,000 [***] [***] [***] [***] [***] [***] [***] [***] 600,000,000 6.2 Payment Adjustments.

  • Shared Study" means any of the Existing Studies (including Allos Studies and Pediatric Studies), EMA Approval Additional Studies or Additional Studies.

  • For clarity, if the Removal Condition is achieved after [time period redacted] of First EMA Approval, no milestone payments will be due for milestone event (4) or milestone event (5).


More Definitions of EMA Approval

EMA Approval means the grant of Marketing Authorization by the European Medicines Agency.
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EMA Approval means, with respect to a Licensed Collaboration Product, receipt of both (a) Regulatory Approval from the EMA of an MAA for such Licensed Collaboration Product in the EU under the centralized EMA filing procedure and (b) pricing and reimbursement approvals in any [***] of the Major European Countries; provided, however, that if the centralized EMA filing procedure is not used, EMA Approval will be achieved upon receipt of Regulatory Approval from the applicable Regulatory Authority of an MAA for such Licensed Collaboration Product and receipt of pricing and reimbursement approvals in any [***] of the Major European Countries.
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EMA Approval means all approvals, licenses, permits, notifications, registrations, clearances, authorizations or waivers of the European Medicines Agency (EMA), that is or are necessary to initiate marketing and selling a Product in the jurisdiction(s) governed by the EMA;
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EMA Approval means either (a) receipt of Regulatory Approval by the EMA of an MAA filed with the EMA for the applicable Licensed Product under the centralized EMA filing procedure, or (b) if the centralized EMA filing procedure is not used, receipt of Regulatory Approval for the applicable Licensed Product in three (3) of the Major European Countries and, where applicable, receipt of pricing and reimbursement approvals, for the applicable Licensed Product.
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EMA Approval means the grant of a Marketing Authorisation of a Qualifying Product by the European Commission valid in the European Union or by a Regulatory Authority in a member state of the European Union valid in such member state; “[***] Consideration” means US[***] in cash;
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EMA Approval means, with respect to any Product and any specific indication, Marketing Authorization by the EMA for such Product in such indication.
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Related to EMA Approval

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • Regulatory Approval means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.