MAJOR MILESTONE EVENT definition

MAJOR MILESTONE EVENT means each of those events that are specifically designated as such in a particular DEVELOPMENT PLAN, and that xxxx significant milestones demonstrating progress by GENAISSANCE in the development of a PRODUCT, such as [***], and the filing of an NDA, in each case [***].
Sample 1
MAJOR MILESTONE EVENT has the meaning set forth in Section 6.02(a). “Major Milestone Outside Date” has the meaning set forth in Section 6.02(a). “Master Ground Lease” has the meaning set forth in the Recitals.
Sample 1
MAJOR MILESTONE EVENT has the meaning set forth in Section 6.02(a).
Sample 1

More Definitions of MAJOR MILESTONE EVENT

MAJOR MILESTONE EVENT and “Major Milestone Outside Date” means the Major Milestone Event and the corresponding Major Milestone Outside Date set forth directly across from said Major Milestone Event in the chart below:
Sample 1

Related to MAJOR MILESTONE EVENT

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

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

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

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

  • 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.

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

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

  • Sales Milestone Payment is defined in Section 5.3.

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

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

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

  • 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;

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

  • Milestone Payment Date has the meaning set forth in Section 2.4(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. [***]

  • 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 Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

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