Commercial Sale Milestone definition

Commercial Sale Milestone is defined in ‎‎Section 2.3(b).
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Commercial Sale Milestone means the sale of an Applicable Product (A) in the U.S.A., following approval of the product by the U.S. Food and Drug Administration (the “FDA”), or (B) in the European Union, following approval of the product by the European Medicines Agency. “Applicable Product” means a licensed product using the proprietary technology of Brookwood or its Subsidiaries.
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Commercial Sale Milestone is defined in Section 2.4(b)
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Examples of Commercial Sale Milestone in a sentence

  • Pfizer Payments to BIND 33 8.1. Initial License Fee 33 8.2. Option Fee 34 8.3. Development Milestone Payments 34 8.4. Supplemental NDA Milestone Payments 35 8.5. Regulatory Approval Milestone Payments 36 8.6. First Commercial Sale Milestone Payments 36 8.7. Sales Milestones 37 8.8. Royalties 38 8.9. Third Party Licenses 39 8.10.

  • The First Commercial Sale Milestone Payment shall be paid together with the Earn-Out-Payment of the Calendar Quarter during which the First Commercial Sale milestone event has been achieved.

  • This may be because you feel the decision was not properly considered or reasonably justified.

  • Promptly (and in any event within five (5) Business Days) following the receipt by Assignee of any report, notice, correspondence or confidential information related to either the NDA Milestone or Commercial Sale Milestone provided by Zevra under the Zevra Agreement, Assignee shall furnish a true, correct and complete copy of the same to Assignor.

  • Takeda shall pay to TBIL each of the Development, Regulatory Approval and First Commercial Sale Milestone Payments and the Aggregate Sales Milestone Payments (each, a “Milestone Payment”) upon achievement of the corresponding milestone event described herein (each such event, a “Milestone Event”).

  • E).• Pull the electrical components unit (26) out of the base plate.• Using a screwdriver with an insulated handle, touch the 2 capacitor connections (14).

  • The Agreement is hereby amended such that the First Commercial Sale Milestone payment referred to in clause (b) of Section 2.6.1 thereof (First Commercial Sale of an Imaging (MIP-1404) Product) in the amount of $10,000,000 (the “XXX-0000 Xxxxxxxxx Payment”) shall not be payable within twenty (20) days following the occurrence of such First Commercial Sale Event as provided in Section 2.9.2 of the Agreement.

  • Takeda shall have no obligation to make any Development, Regulatory Approval, or First Commercial Sale Milestone Payments following notice of termination to TBIL.

  • The Parties agree that notwithstanding Section I (d) of Exhibit 1.16 to the contrary, the First Commercial Sale Milestone Payment shall be due no later than January 15, 2023.

Related to Commercial Sale Milestone

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • 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).

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

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

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • 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;

  • Sales Milestone Payment is defined in Section 5.3.

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

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

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

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

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

  • 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;

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

  • First Commercial Sale means, with respect to any Licensed Product, the first sale for use or consumption by the general public of such Licensed Product in any country in the Territory after Approval of such Licensed Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.

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

  • 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.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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).

  • 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 III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.