Commercialization Milestone Events definition

Commercialization Milestone Events means the Phase II Milestone Event, the Phase III Milestone Event, and the Approval Milestone Event.
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Commercialization Milestone Events means the IND Filing Milestone Event, the IND Acceptance Milestone Event, the Phase III Milestone Event, the Approval Milestone Event, and the Approval Amendment Milestone Event.
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Commercialization Milestone Events means the Clinical Milestone Event, the Approval-US Milestone Event, and the Approval-Europe Milestone Event.
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Examples of Commercialization Milestone Events in a sentence

  • The Milestone Payments for Commercialization Milestone Events are set forth in Table 2 below.

  • The specific milestone payments due to Intrexon upon achievement of each of the Commercialization Milestone Events are set forth in Sections 5.2(a)(i) through 5.3(a)(iii) below.

  • The Parties agree that Oragenics’ option to pay any milestone payments that come due for achievement of Commercialization Milestone Events under this Agreement in equity shall in no event require Intrexon to accept equity of Oragenics as payment if, upon Intrexon’s reasonable conclusion after consultation with its outside advisors, receipt of such equity payment by Intrexon would cause Intrexon to have to consolidate Oragenics’ financial statements with Intrexon’s financial statements.

  • The specific milestone payments due to Intrexon upon achievement of each of the Commercialization Milestone Events are set forth in Sections 5.2(a)(i) through 5.3(a)(vi) below.

  • In the event that Oragenics consummates a Company Sale prior to paying to Intrexon any one or more of the respective milestone payments set forth in Sections 5.2(a)(i) through 5.2(a)(iii) and this Agreement is transferred or assigned to the buyer in connection with such Company Sale, then all subsequent payments for Commercialization Milestone Events shall thereafter each be payable only in cash to Intrexon.

  • Additionally, upon the attainment of certain Commercialization Milestone Events by a Collaboration Product (whether such attainment is achieved by Synthetic or by a permitted sublicensee), Synthetic has agreed to pay Intrexon additional milestone payments as set forth in this Section 5.2(b).

  • First calendar year in which aggregate annual Net Sales of all Products in the Territory equal or exceed [*] [*] If multiple Commercialization Milestone Events are achieved in any given calendar [*], the Commercialization Milestone Payments corresponding to all of such achieved Commercialization Milestone Events shall be paid within [*] of the end of such calendar [*].

  • For clarity, each of the three (3) separate Commercialization Milestone Events will trigger payment by Oragenics only once (i.e., only the first time each such Commercialization Milestone Event in question is Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  • For example, if aggregate Annual Net Sales for a Product Directed To a given Collaboration Target equal [***] in a given Calendar Year, and no Commercialization Milestone Payments have been made with respect to Products Directed To such Collaboration Target in previous Calendar Years, MKDG shall pay C4T [***] in Commercialization Milestone Payments pursuant to this Section 6.4.2 for the Calendar Year in which both such Commercialization Milestone Events were first achieved.

  • The maximum aggregate amount payable pursuant to this Section 9.4 following achievement of all Commercialization Milestone Events is USD 862.5 million.

Related to Commercialization Milestone Events

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Events has the meaning set forth in Section 7.2.

  • Development Milestone is defined in Section 5.3.

  • Milestone Event has the meaning set forth in Section 1.11(a).

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

  • 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;

  • Project Milestones means the Project milestones set out in Schedule 3;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • 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).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

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

  • 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.

  • 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 I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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).

  • 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.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Milestone Date means the target date set out against the relevant Milestone in the Implementation Plan by which the Milestone must be Achieved;

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

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