EU Milestone definition

EU Milestone will be deemed to occur upon Buyer’s or its Affiliates’ (or their respective successors or assigns) receipt of approval (whether full, accelerated, conditional or otherwise) by the European Commission of a “marketing authorisation application” in the European Union, through the centralized procedure, for the Product, which authorization grants Buyer or its Affiliates (or their respective successors or assigns) the right to market and sell the Product in the European Union in accordance with Applicable Law for the treatment of duchenne muscular dystrophy, including subject to any applicable label restrictions. For the avoidance of doubt, the EU Milestone does not refer to approval in one or more individual countries of the European Union or to a positive opinion by the European Medicines Agency Committee for Medicinal Products for human use.
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EU Milestone means the attainment of both of the following milestones during the applicable Milestone Period for each: (i) Milestone #1, and (ii) Milestone #2.
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EU Milestone means the first achievement of either: (i) a centralized marketing authorization for SGN-CD33A in the EU that is granted by the European Commission (or any successor entity thereto) to the Company, any Subsidiary and/or any Partner; or (ii) receipt by the Company, any Subsidiary and/or any Partner of the approvals necessary for the commercial sale and marketing of SGN-CD33A in four of the five Major European Countries.
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Examples of EU Milestone in a sentence

  • The Company shall have performed and complied with all agreements, obligations, and conditions contained in this Agreement that are required to be performed or complied with by it on or before the EU Milestone Closing Date.

  • All corporate and other proceedings in connection with the transactions contemplated at the EU Milestone Closing and all documents incident thereto shall be reasonably satisfactory in form and substance to Schering and Schering's counsel, and they shall have received all such counterpart original and certified or other copies of such documents as they may reasonably request.

  • Every person that carries out a construction or improvement project in an urban center, as provided by law, may qualify to claim a credit against the tax.The concession of the credit is subject to the Trust’s request and the approval by the Secretary of the Treasury of an administrative determination.

  • Schering shall have received from counsel for the Company an opinion addressed to Schering substantially covering the matters set forth in Sections 2.1, 2.2, 2.3 (as to the due authorization, valid issuance, full payment and nonassessability of the Shares to be purchased at the EU Milestone Closing), 2.12, 2.13 and 2.14 (as to federal law).

  • Schering shall have performed and complied with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the EU Milestone Closing Date.

  • The warranties, representations, agreements, covenants and undertakings of the Company or Schering contained in or made pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Initial Closing, the U.S. Milestone Closing and the EU Milestone Closing, as the case may be, and shall in no way be affected by an investigation of the subject matter thereof made by or on behalf of Schering or the Company.

  • The training program shall address fundamentals of nonbeam hazards, management and employee responsibilities relating to control measures, and regulatory requirements.(3) Complete a board-approved certification application form and submit to the board office the completed form, a copy of the certification of training, and the required fee pursuant to 645—subrule 5.5(14).

  • The Chief Executive Officer of the Company shall deliver to Schering at the EU Milestone Closing a certificate certifying that the conditions specified in Sections 4.3(a), 4.3(b), and 4.3(c) hereof have been fulfilled and stating that there has been no Material Adverse Change in the Company, since the Initial Closing.

  • At the EU Milestone Closing, the Company shall deliver to Schering a certificate or certificates, registered in Schering's name, representing the Shares purchased at the EU Milestone Closing, and Schering shall pay the total consideration for such Shares by wire transfer in immediately available funds to an account designated by the Company.

  • During the US Milestone Period, Buyer (and its successors and assigns) will, and will cause its (and their) Affiliates to, use Diligent Efforts to achieve the US Milestone prior to the end of the US Milestone Period, and during the EU Milestone Period, Buyer (and its successors and assigns) will, and will cause its (and their) Affiliates to, use Diligent Efforts to achieve the EU Milestone prior to the end of the EU Milestone Period.


More Definitions of EU Milestone

EU Milestone is satisfied upon the Surviving Company receiving regulatory approval prior to the 10th anniversary of the Closing Date from the EU European Medicines Agency for the first Protein Based Product and/or the first Steroid Based Product. Upon satisfaction of the EU Milestone for the first Protein Based Product, Purchaser will pay $2.5 million to the Stockholders’ Representative’s designee for further distribution to the Participating Holders. Upon satisfaction of the EU Milestone for the first Steroid Based Product, Purchaser will pay $1.25 million to the Stockholders’ Representative’s designee for further distribution to the Participating Holders.
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Related to EU Milestone

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

  • 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.

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

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

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

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

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

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

  • 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 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;

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • EBITDA Target means the Company's projected earnings before interest, taxes, one-time transition expenses, non-cash compensation expense charges, depreciation and amortization, as contained in the Company's budget for the Applicable Period and which is approved by the Board (without reference to any adjustments or revision, upwards or downwards, to such projected earnings which are subsequently approved by the Board as part of any subsequent revision to such budget), and (ii) the term "Financial Results" shall mean the Company's EBITDA calculated by reference to the Company's financial statements for the Applicable Period as filed with the Securities and Exchange Commission (the "SEC").

  • Milestone Payments has the meaning set forth in Section 4.2.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.