Development and Regulatory Milestone Payments definition

Development and Regulatory Milestone Payments shall have the meaning provided in Section 5.2.
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Development and Regulatory Milestone Payments has the meaning set forth in Section 6.2.1 (Development and Regulatory Milestones).
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Examples of Development and Regulatory Milestone Payments in a sentence

  • In no event will the total amounts payable by the Licensee to BioMedica under this Clause 8.2 (Development and Regulatory Milestone Payments) exceed [***].

  • With respect to a given Product for a given Indication, the milestone events set forth in this Section 8.2 (Development and Regulatory Milestone Payments) based upon a Clinical Trial (each, a “Clinical Milestone Event”) are intended to be successive in the order in which they are listed.

  • Million in Clinical Development and Regulatory Milestone Payments.

  • Development & Regulatory Milestones (Tax Included) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Total Possible Development and Regulatory Milestone Payments (Including Additional Payment B) RMB Three Hundred and Twenty Million (¥320,000,000) Milestone Event Milestone Payment B.

  • The Licensee shall make the payments referred to in Clause 8.2 (Development and Regulatory Milestone Payments), Clause 8.3 (Commercial Milestone Payments), and Clause 8.5 (Net Receipts), and Clause 8.6 (Paediatric Priority Review Voucher) within [***] after receipt of an invoice from BioMedica, provided that each milestone payment shall be due only once.

  • Deviating, contrary or supplementary general terms and conditions by the vendor shall become a part of the contract only and insofar as we have expressly agreed in writing to their validity.

  • Development and Regulatory Milestone Payments: At the inception of each arrangement that includes development and regulatory milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

  • Within [***] of receipt of such invoice, Dermavant will pay to Portola the following non-refundable, non-creditable milestone payments: Milestone Event Milestone Payment [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Total Development and Regulatory Milestone Payments [***] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD.

  • The actual proposal will be submitted at a later date for official approval.

  • Lilly shall make milestone payments to Rigel based on achievement of certain development and regulatory milestone events as set forth in this Section 8.2 (Development and Regulatory Milestone Payments).

Related to Development and Regulatory Milestone Payments

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

  • Milestone Payments has the meaning set forth in Section 4.2.

  • 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;

  • Development Milestone Event 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;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

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

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

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

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

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

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Development Plan has the meaning set forth in Section 3.2.

  • 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 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.

  • 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.

  • Development Program means the implementation of the development plan.

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • 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.

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

  • 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).

  • Development Plans has the meaning set forth in Section 3.2.