510(k) Milestone definition

510(k) Milestone means the written clearance by the FDA of a 510(k) notification that is originally submitted by the Surviving Corporation after the Closing and on or before June 30, 2013 for a Retrieval Device for the commercial sale of such Retrieval Device in the United States. For purposes of this definition, the 510(k) notification shall be deemed to be submitted on the date on which the Surviving Corporation deposits, or causes to be deposited, in the U.S. mail or with a third party courier service, the 510(k) notification for delivery to the FDA.
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510(k) Milestone means the date that […***…].
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510(k) Milestone has the meaning set forth in Section 1.7(a).
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Examples of 510(k) Milestone in a sentence

  • If the 510(k) Milestone does not occur by December 31, 2014, then no 510(k) Milestone Payment will be due or payable.

  • Any payment of the 510(k) Milestone Payment pursuant to this Section 1.7(a) shall be made to the Company within five (5) Business Days of the occurrence of the 510(k) Milestone by wire transfer of immediately available funds to an account designated by the Company.

  • Upon the achievement of the 510(k) Milestone, Purchaser shall pay to the Company a one-time payment (the “510(k) Milestone Payment”) in the amount of (i) Two Million Dollars ($2,000,000) if the 510(k) Milestone occurs on or before September 30, 2014 or (ii) One Million Dollars ($1,000,000) if the 510(k) Milestone occurs after September 30, 2014 and on or before December 31, 2014.

Related to 510(k) Milestone

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

  • 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.

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

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

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

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

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

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

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

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

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

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

  • 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").

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

  • 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 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).

  • 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. [***]

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.