Commercialization Milestone Event definition

Commercialization Milestone Event means any one of the Phase II Milestone Event, the Phase IIb/III Milestone Event, the Regulatory Approval Application Milestone Event, the Approval Milestone Event, the New Indication Milestone Event, and the New Product Milestone Event.
Commercialization Milestone Event means a milestone event set forth in Section 5.4(d).
Commercialization Milestone Event means any commercialization milestone event described in any of the tables in Section 8.3.

Examples of Commercialization Milestone Event in a sentence

  • Subject to the terms and conditions of this Agreement and the Channel Agreement, upon the first attainment of Commercialization Milestone Event (as defined in the Channel Agreement), the Company has agreed to make certain milestone payments (each a “Milestone Payment” and together “Milestone Payments”), at the Company’s option either in the form of shares of Company Common Stock (based upon the Fair Market Value of the shares).

  • Oragenics will pay Intrexon any amount due under this Section 5.2(c) within the later of (i) thirty (30) days from underlying Commercialization Milestone Event, or (ii) ten (10) days following the date stipulated in the underlying Product Sublicense for Oragenics to receive the milestone payment.

  • Jazz will pay to Zymeworks the applicable Commercialization Milestone Payment no later than [***] after its receipt of such invoice (but in any event no later than [***] following such first achievement of such Commercialization Milestone Event).

  • In the event that more than one Commercialization Milestone Event is first achieved in a given Calendar Year, Jazz shall pay Zymeworks the Commercialization Milestone Payment associated with each such Commercialization Milestone Event achieved during such Calendar Year.

  • Jazz will notify Zymeworks in writing within [***] of the first achievement of any Commercialization Milestone Event [***].

  • GSK shall notify Zymeworks in writing of the achievement of a Development Milestone Event or Commercialization Milestone Event within […***…] days of its achievement, and Zymeworks shall issue an Invoice to GSK for the corresponding Development Milestone Payment or Commercial Milestone Payment.

  • GSK shall notify Zymeworks in writing of the achievement of a Development Milestone Event or Commercialization Milestone Event within […***…] of its achievement, and Zymeworks shall issue an Invoice to GSK for the corresponding Development Milestone Payment or Commercial Milestone Payment.

  • During the quarter, the company received significant international orders for Harris ONE™ solutions from Qatar, Iraq, India, Australia, Lebanon, Turkey, Nigeria, Russia, Bulgaria, Slovenia, Italy, Germany, Belgium, Switzerland, and Mexico.

  • Celgene shall provide Zymeworks with notice of the achievement of each Development Milestone Event and Commercialization Milestone Event within […***…] thereafter and make the corresponding Milestone Payment within […***…] after such achievement.

  • To this end, upon each achievement of any Commercialization Milestone Event that triggers a milestone payment being due by Oragenics to Intrexon under Section 5.2(a) above, Oragenics shall notify Intrexon as soon as possible if Oragenics intends to elect to pay the specific milestone payment in equity, such notification being in writing and delivered to Intrexon in no event less than ten (10) business days from the date of achievement of the respective Commercialization Milestone Event.


More Definitions of Commercialization Milestone Event

Commercialization Milestone Event means any one of the Regulatory Approval Milestone Event, the New Indication Milestone Event, and the New Product Milestone Event.
Commercialization Milestone Event shall have the meaning set forth in Section 11.2(b).
Commercialization Milestone Event shall have the meaning set forth in Section 6.6.2.

Related to Commercialization Milestone Event

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

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

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

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

  • 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;

  • 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.

  • 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.

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

  • 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.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • 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 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 Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

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

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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.

  • 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)).

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.