Milestone Ib definition

Milestone Ib means the Successful Completion of the MG Phase II Development Program for Product in MG.
Sample 1

Examples of Milestone Ib in a sentence

  • Under the Amendment to IFRS 2, Milestone Ib is determined to be a non-vesting condition.

  • As Milestone Ib was not originally fair valued, the Directors have undertaken an assessment of the financial effects of applying the Amendment to IFRS 2 and the potential impact of this amendment on the 2009 disclosures and 2008 comparative disclosures.

  • Specifically, this arises in respect of the fair value attributable to the Milestone Ib equity-settled share-based payment component of the Ester Neurosciences Limited asset acquisition which occurred on 5 December, 2007 (see notes 4 and 35 for details).

  • As Milestone Ib was not originally fair valued, the Directors have undertaken an assessment of the financial effects of applying the Amendment to IFRS 2 and the potential impact of this amendment on the 2009 disclosures and 2008 comparative disclosures (see note 9 for further details).

  • Under the Amendment and Waiver Agreement, in relation to Milestone Ib, Amarin has a contractual obligation to pay to Medica only to the extent monies received (if any) from a third party licensee or partner up to a maximum of $6,000,000.

  • Milestone Ib is also an equity-settled share based payment transaction under IFRS 2, however, as it was not deemed probable that the conditions for achieving Milestone Ib (as described in note 4) would be met, no amount has been recognised in share based payment reserve or the corresponding intangible asset.

  • The Amendment and Waiver Agreement, which reflects Amarin’s intention to seek a partner for EN101, provides for the release of Amarin from all research and development diligence obligations contained in the original agreement, with all remaining payment obligations payable by Amarin (Milestone Ib and Milestone II) being made from the monies received from potential partners.

Related to Milestone Ib

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

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

  • 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.

  • 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).

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

  • 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;

  • 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.

  • Sales Milestone Payment is defined in Section 5.3.

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

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

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

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

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

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

  • 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;

  • 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 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 Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Development approval means any written authorization from a

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

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.