EU Approval Milestone definition

EU Approval Milestone means receipt of the first MAA Approval for a Covered Product.
Sample 1

Examples of EU Approval Milestone in a sentence

  • The parties agreed that most milestone payments would depend on the occurrence of a specific event: the U.S. Approval Milestone occurs when Shire receives “a written letter of approval by the FDA of a[] [new drug approval application]”; the E.U. Approval Milestone occurs when Shire receives “written approval by the [European Medicines Agency] to market and sell” the drug; and the First and Second Net Sales Milestones occur when aggregate worldwide net sales exceed $500 million and $1 billion, respectively.

  • In particular, Section 2.9 of the Merger Agreement provided for five milestone payments with respect to deferitazole: (1) a $45 million Initiation of Phase III Clinical Trial Milestone4; (2) a $50 million US Approval Milestone; (3) a $30 million EU Approval Milestone; (4) a $50 million First Net Sales Milestone; and (5) a $50 million Second Net Sales Milestone.

Related to EU Approval Milestone

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Event has the meaning set forth in Section 8.4.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

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

  • 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.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

  • 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 that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Non-Approval Event means, in respect of the Benchmark:

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Development approval means any written authorization from a