Development Milestone Payment 3 in Section 1.1 of the Warrant Agreement is deleted and replaced in its entirety with the following:
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Development Milestone Event shall have the meaning set forth in Section 9.2(a).
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 means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
Milestone Payment Date has the meaning set forth in Section 2.4(a).
Milestone Event has the meaning set forth in Section 8.4.
Milestone Payments has the meaning set forth in Section 4.2.
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 Events has the meaning set forth in Section 3.3 (Milestone Payments).
Project Milestone means the project milestone set forth in Schedule-J;
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Project Milestones means the project milestones set forth in Schedule-G;
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.
Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.
Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.
Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).
Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.
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).
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Development Plan has the meaning set forth in Section 3.2.
KPI Target means the acceptable performance level for a KPI as set out in each KPI;