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

  • Histogenics shall pay Intrexon a milestone payment of three million United States dollars ($3,000,000) within thirty (30) days of the first instance of the achievement of the Phase III Milestone Event, said payment being made, at Histogenics’ option subject to Section 5.3(b) and 5.3(c), either in cash or in shares of Histogenics’ common stock.

  • 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.

  • 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.

  • 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 [* * *].

  • 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).

  • 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.

  • After Interconnection Customer or MHVDC Connection Customer enters the Definitive Planning Phase III, the Definitive Planning Phase II (M3) milestone payment becomes 100% non-refundable, pursuant to Section 7.8. 7.3.2.4.1 Definitive Planning Phase III Milestone (M4) Calculation.The Definitive Planning Phase III milestone (M4) will be in the form of either cash or irrevocable letter of credit reasonably acceptable to Transmission Provider.

  • There was an unrecorded assets of Rs. 500 which was taken over by S at Rs. 400.


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 has the meaning set forth in Section 7.1.

  • 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, if applicable, must be completed by the relevant Milestone Date;

  • 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 is defined in Section 5.3.

  • 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 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. [***]

  • 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 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 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 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.

  • 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 human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

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

  • 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 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.