Table 1 No. Development Milestone Event Development Milestone Payment 1.
Notwithstanding anything to the contrary in this Agreement, Gilead shall have no obligation to pay Development Milestone Payment #1 of [**] for the [**] if [**].
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).
Sales Milestone Payment shall have the meaning set forth in Section 8.4.
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;
Milestone Payment Date has the meaning set forth in Section 2.4(a).
Milestone Event has the meaning set forth in Section 8.4.
Project Milestone means the project milestone set forth in Schedule-J;
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 Payments has the meaning set forth in Section 4.2.
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Project Milestones means the project milestones set forth in Schedule-G;
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
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.
Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.
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.
Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.
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.
Additional Indication means any indication other than the Initial Indication.
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 IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.
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).
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
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)).