Sarepta acknowledges receipt from Myonexus of a Development Milestone Event Notice with respect to Development Milestone 2 and agrees that all conditions to payment of the Development Milestone Payment 2 set forth in the Warrant have been satisfied as of the date of this Letter Agreement.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Development Milestone is defined in Section 5.3.
Development Milestone Event has the meaning set forth in Section 7.2.1.
Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;
Milestone Payment has the meaning set forth in Section 4.2.
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 8.2.1.
Milestone Payments means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).
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;
Milestone Events has the meaning set forth in Section 7.2.
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.
Milestone Notice has the meaning set forth in Section 2.4(a).
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.
Initial Indication means the use of a Product for the treatment of opioid addiction.
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).
Additional Indication means any indication other than the Initial Indication.
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).