Phase III Milestone definition

Phase III Milestone means Borrower’s delivery to Bank of evidence, in form and substance satisfactory to Bank in its sole discretion, that Borrower has (a) dosed its first patient in the Phase IIB pulmonary arterial hypertension trial and (b) dosed its first patient in the Verso Phase I trial.
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Phase III Milestone means the initiation after the Closing Date of a Phase III Clinical Trial intended to meet the requirements for approval of an NDA for a product incorporating proprietary technology of Brookwood or its Subsidiaries where such product was developed and such Phase III Clinical Trial is initiated in collaboration with a pharmaceutical and/or healthcare company that had annual global sales of healthcare products in its fiscal year that preceded the initiation of such Phase III Clinical Trial of $10 billion or more.
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Phase III Milestone is defined in Section 2.4(b).
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Examples of Phase III Milestone in a sentence

  • In addition, on the date on which ALPHARMA Parent issues to IDEA the Phase III Milestone Warrant and the Approval Warrant, ALPHARMA Parent and IDEA shall execute and deliver a Registration Rights Agreement in the form attached to this Agreement as Schedule I.

  • The Phase III Milestone Advance shall be payable by Pfizer to GMI within forty-five (45) days after the end of such twelve (12) month period if Pfizer has not provided written notice to GMI of a [* * *] or [* * *], if [* * *].

  • Provided that (i) Borrower has achieved the Positive Phase I/II Milestone, and (ii) all other conditions precedent to the initial Credit Extension have been satisfied, Bank shall make a Growth Capital Advance under Tranche A to Borrower in an amount equal to Four Million Dollars ($4,000,000) (the “Tranche A Growth Capital Advance”) on the Effective Date.

  • If, as a result of a Supply Agreement Negotiation Failure, Tarsus fails to supply, or cause to be supplied, Licensed Products to Lian for Development purposes and as a direct result of such failure to supply Lian is not able to achieve the Phase III Milestone by the applicable Completion Date, then such Completion Date will be extended by the number of days from the expiration of such [***] day period until such time as Tarsus is able to supply, or cause to be supplied, Licensed Products to Lian.

  • The Phase III Milestone Advance shall be payable by Pfizer to GMI within forty-five (45) days after the end of such twelve (12) month period if Pfizer has not provided written notice to GMI of a determination that an Additional Phase II Clinical Trial is necessary or [* * *] after such [* * *] period described herein, if a patient has not been dosed in such Additional Phase II Clinical Trial within such [* * *] period.

  • For the achievement of any ADA Phase III Milestone in connection with the first Independent ADA the milestone payment amount under Sections 7.2.1 owed for the achievement of such ADA Phase III Milestone in connection with such Independent ADA shall become due and payable to Alector upon the ADA Data Use Date for such Independent ADA.

  • IDEA acknowledges and agrees that, prior to the First Amendment Date, ALPHARMA has paid to IDEA the sixty million U.S. dollar ($60,000,000) payment set forth in Section 3.1 of the Agreement and that ALPHARMA Parent has issued to IDEA the Phase III Milestone Warrant and the Approval Warrant and entered into the Registration Rights Agreement with IDEA, all in accordance with Section 3.1 of the Agreement.

  • Subject to Section 1(d), the Purchase Price shall be 150% of the 30-Day Average Common Stock Trading Price as of the Phase III Milestone Date (as defined below); provided, however, that the Purchase Price shall not, in any event, be less than $22.50 (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock occurring at any time after the date hereof).

  • The amount and pricing of the Phase III Milestone (“Series A”) warrants are tied to positive phase III results, and the Form of Approval (“Series B”) warrants are tied to FDA approval.

  • In consideration of the grant by IDEA of the licenses set forth in Section 2.1, ALPHARMA shall within [**] calendar days after the Effective Date (a) pay IDEA a non-refundable, non-creditable license fee of sixty million US dollars (US$60,000,000), and (b) cause ALPHARMA Parent to issue to IDEA a Phase III Milestone Warrant in the form attached to this Agreement as Schedule G and (c) cause ALPHARMA Parent to issue to IDEA an Approval Warrant in the form attached to this Agreement as Schedule H.


More Definitions of Phase III Milestone

Phase III Milestone means that the Company has publicly announced successful completion of either the Phase III trial of Diractin referred to as Trial 1 or the Phase III trial of Diractin referred to as Trial 2 in Schedule F of the License Agreement, with efficacy and safety results that the Company believes warrant proceeding (without conducting any additional or new clinical trials other than successful completion of the other of such Trial 1 or Trial 2) with the filing of a New Drug Application with the U.S. Food and Drug Administration for the approval of Diractin as a topical treatment for pain.
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Phase III Milestone means that the Company has publicly announced successful completion of either the Phase III trial of Diractin referred to as Trial 1 or the Phase III trial of Diractin referred to as Trial 2 in Schedule F of the License Agreement, with efficacy and safety results that the Company believes warrant proceeding (without conducting any additional or new clinical trials other than successful completion of the other of such Trial 1 or Trial 2) with the filing of a New Drug Application with the U.S. Food and Drug Administration for the approval of Diractin as a topical treatment for pain. "Phase III Milestone Date" means the date on which the Phase III Milestone has occurred. "Proportionate Part" means a fraction, the numerator of which is the number of Warrant Shares purchasable upon the exercise of this Warrant (as of the date on which the Company repurchases this Warrant pursuant to Section 1, or as of the date on which this Warrant is exercised, as applicable) by the Registered Holder (giving effect to any subdivision of this Warrant pursuant to Section 7), and the denominator of which is the aggregate number of Warrant Shares initially purchasable by all Registered Holders of this Warrant (as of the date on which the number of Warrant Shares is fixed, but subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock occurring at any time after such date). "Termination Date" means the earliest to occur of (i) the fifth anniversary of the Approval Date, (ii) the tenth anniversary of the date hereof, (iii) if the License Agreement terminates prior to Approval Date, the date of such termination of the License Agreement and (iv) if the Warrant is repurchased by the Company for $12,500,000 pursuant to Section 1, the date of such repurchase.
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Related to Phase III Milestone

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

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

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

  • Milestone Date means the date set against the relevant Milestone in the Implementation 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.

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

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

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

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

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), 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 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.

  • 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).

  • 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 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 Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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 III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • 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.