Developmental Milestone Event definition

Developmental Milestone Event has the meaning set forth in Section 10.7.
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Developmental Milestone Event means a Milestone Event set forth in Section 1.11(a)(i) or in Section 1.11(a)(ii).
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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
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Examples of Developmental Milestone Event in a sentence

  • Novartis will, on a Regional Target-by-Regional Target basis, make the following Developmental Milestone Payments to Surface upon the first achievement of the corresponding Developmental Milestone Event for a Regional Target: [***] [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • Novartis will, on a Global Target-by-Global Target basis, make the following Developmental Milestone Payments to Surface upon the first achievement of the corresponding Developmental Milestone Event for a Global Target: [***] [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • AstraZeneca shall make each of the Developmental Milestone Payments to Pieris set forth in this Section 9.3.4 at the occurrence of each corresponding Developmental Milestone Event in connection with each AZ Dev Product or in connection with a CoDev Product where Pieris does not exercise its CoDev Option with respect to such Product (or if and at the time it later opts-out of co-Development).

  • AstraZeneca shall make each of the Developmental Milestone Payments to Pieris set forth in this Section 9.3.1 at the occurrence of each corresponding Developmental Milestone Event in connection with the Lead Product, unless and until Pieris exercises the Lead Product CoDev Option.

  • Such Developmental Milestone Payments shall be made within [***] days of achievement of the corresponding Developmental Milestone Event.

  • Notwithstanding any other provision of this Agreement, each series of Developmental Milestone Payments will be payable only once with respect to the specified Licensed Target Pair, notwithstanding the number of Licensed Products (or the number of times a Licensed Product) may achieve the applicable Developmental Milestone Event.

  • Novartis shall provide Xencor with written notice of achievement of each Developmental Milestone Event within [...***...] after such Developmental Milestone Event is achieved.

  • Such Developmental Milestone Payments shall be made within [***] days after achievement of the corresponding Developmental Milestone Event.

Related to Developmental Milestone Event

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

  • Milestone Event has the meaning set forth in Section 8.2.1.

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

  • Development Milestone is defined in Section 5.3.

  • 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 has the meaning set forth in Section 4.2.

  • 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).

  • 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 human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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 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.

  • 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, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

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