Developmental Milestone Event definition

Developmental Milestone Event has the meaning set forth in Section 10.7.
Developmental Milestone Event means a Milestone Event set forth in Section 1.11(a)(i) or in Section 1.11(a)(ii).
Developmental Milestone Event has the meaning set forth in Section 8.2. “Developmental Milestone Payment” has the meaning set forth in Section 8.2. “Disclosing Party” has the meaning set forth in Section 10.1.1. “Dispute” has the meaning set forth in Section 14.1.1. “Dollars” or “$” means the lawful currency of the United States. “Early Launch Date” has the meaning set forth in Section 8.6.2. “Effective Date” has the meaning set forth in the Preamble. “EMA” means the European Medicines Agency or any successor to the European Medicines Agency. “European Union” or “EU” means the member states of the European Union as of the Effective Date and the United Kingdom, and such other countries as may become part of the European Union after the Effective Date. “Effective Date” has the meaning set forth in the preamble. “Equity Financing” means any issuance, sale or distribution of capital stock of BP or any of its Affiliates at its then-current fair market value, in any transaction or series of transactions that include(s) participation by at least one Third Party and which transaction is engaged in primarily for equity financing purposes, the proceeds of which shall be deployed to Exploit the Product or otherwise expensed in the business of BP (including an underwritten public offering of any of BP or any of its Affiliate’s capital stock). “Equity Financing Consideration” has the meaning set forth in Section 8.7.3. “Equity Financing Revenue Share” has the meaning set forth in Section 8.7.3. “Exploitation” or “Exploit” means make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, Research, have Researched, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise exploit. For the avoidance of doubt, Exploitation or Exploit may mean any or all of the foregoing, as the context requires. “FDA” means the United States Food and Drug Administration or a successor to the

Examples of Developmental Milestone Event in a sentence

  • Within [**] following January 1st of each calendar year commencing in 2018 and continuing until [**] following the end of the Developmental Diligence Period, the Buyer shall provide the Seller with a reasonably detailed written report (each, an “Annual Report”) summarizing the status of the development of the MRT Products in order to achieve any Developmental Milestone Event that had not yet been achieved.

  • The Buyer shall provide written notice to the Seller of the achievement of each Developmental Milestone Event no later than [**] after the occurrence thereof or after Buyer becomes aware of the achievement of such Developmental Milestone Event.

Related to Developmental 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.

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

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

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

  • 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;

  • 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;

  • 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.

  • 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.

  • 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).

  • 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 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 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.

  • 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.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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.

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

  • 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.