IND Milestone definition

IND Milestone shall have the meaning provided in Section 4.2(a).
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IND Milestone means Bank’s receipt of evidence reasonably satisfactory to Bank of receipt by Borrower of net payments, in one or more installments, from Regeneron equal to Twenty Million Dollars ($20,000,000) occurring within eighteen (18) months after the Closing Date in respect of Borrower’s achievement of (i) Borrower’s filing of an investigational new drug application with the FDA for ADI-001 and (ii) selection of a second clinical product candidate, “ADI-002”.
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IND Milestone shall have the meaning set forth in Section 1.11(a)(i).
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Examples of IND Milestone in a sentence

  • The Alliance Managers will be members of the JSC, will jointly oversee the conduct of the Development until the later of the IND Milestone Date and the expiration of the Backup Compound Research Program Term.

  • In any event, prior to the IND Milestone Date, any Paratek representative to the JSC may call a meeting of the JSC not more than once each Calendar Quarter and after the IND Milestone Date, may call a meeting not more than twice per Calendar Year.

  • Notwithstanding the foregoing, if Borrower achieves the IND Milestone, at Borrower’s written election received by Bank prior to the end of the Interest-Only Period set forth above, (i) the Interest-Only Period shall be extended through and including the first day of the twenty-fourth (24th) month after the Funding Month and (ii) Borrower shall repay the Term Loan in thirty (30) equal installments of principal, plus monthly payments of accrued interest.


More Definitions of IND Milestone

IND Milestone means the occurrence and/or the achievement of all of the following:
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IND Milestone means the acceptance (wherein “acceptance” means that a clinical study in humans may be initiated based on such IND) of an IND for a Company Product by a Regulatory Authority in any country in the world.
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IND Milestone means the date on which the treatment of the first patient under an Initial New Drug Application for a Collaboration Product commences in a Phase I Clinical Trial.
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IND Milestone means Bank’s receipt of evidence, in form and substance satisfactory to Bank, of investigational new drug application clearance by the FDA of a candidate derived from the Company’s iPSC platform. “Prepayment Fee” is, with respect to the Term Loan subject to prepayment prior to the Term Loan Maturity Date, whether by mandatory or voluntary prepayment, acceleration or otherwise, an additional fee payable to Bank in amount equal to:
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IND Milestone has the meaning set forth in Section 1.8.
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IND Milestone means Bank’s receipt of evidence, in form and substance satisfactory to Bank, of investigational new drug application clearance by the FDA of a candidate derived from the Company’s iPSC platform.
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Related to IND Milestone

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

  • 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 means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

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

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

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

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

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

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

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

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

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

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

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

  • 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 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 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.

  • Additional Indication means any indication other than the Initial Indication.

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.