EMEA Approval definition

EMEA Approval means the issuance by the European Agency for the Evaluation of Medicinal Products (the "EMEA") of the marketing authorization (excluding any pricing approvals) necessary for the sale of Product within the European Community for one or more indications.
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EMEA Approval means the date of EMEA’s approval of an MAA for Licensed Product filed by or on behalf of Anesta for marketing the Licensed Product in the [**].
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EMEA Approval means, in respect of a pharmaceutical product, any and all marketing authorization approvals granted by the EMEA, or the expiration of any applicable mandatory waiting periods that are in lieu of such approvals, necessary to commercialize such product in the countries governed by the EMEA.
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Examples of EMEA Approval in a sentence

  • Notwithstanding the foregoing, through the EMEA centralized regulatory approval process, EMEA Approval of the Product (as defined in the Restated Asset Purchase Agreement) in these three countries has been obtained and will be automatically transferred to the Purchaser as a result of the transfer of the EMEA approvals in the Territory.


More Definitions of EMEA Approval

EMEA Approval means any and all approvals, licenses, registrations or authorizations granted or issued by the EMEA, necessary to commercially distribute, promote and sell the Compound.
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EMEA Approval means the issuance by the European Agency for the Evaluation of Medicinal Products (the "EMEA") of the marketing authorization (excluding any pricing approvals) necessary for the sale of Product within the European Community for one or more indications. CONFIDENTIAL TREATMENT REQUESTED. THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT THE PLACES INDICATED BY ASTERISKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Related to EMEA 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.

  • CFIUS Approval means (i) the Company and the applicable Purchaser(s) shall have received written notice from CFIUS that review under Section 721 of the Defense Production Act of 1950 as amended by the Foreign Investment Risk Review Modernization Act of 2018, including implementing regulations thereof, 31 C.F.R. Parts 800 and 802 (the “DPA”), of the transactions contemplated hereby has been concluded, and CFIUS shall have determined that there are no unresolved national security concerns with respect to the transactions contemplated hereby, and advised that action under Section 721 of the DPA, and any investigation related thereto, has been concluded with respect to the transactions contemplated hereby; (ii) CFIUS shall have concluded that the transactions contemplated hereby are not covered transactions and are not subject to review under Section 721 of the DPA; or (iii) CFIUS shall have sent a report to the President of the United States (the “President”) requesting the President’s decision on the notice and either (1) the period under Section 721 of the DPA during which the President may announce his decision to take action to suspend or prohibit the transactions contemplated hereby shall have expired without any such action being announced or taken or (2) the President shall have announced a decision not to take any action to suspend or prohibit the transactions contemplated hereby.