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 has the meaning set forth in Section 1.8.
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Examples of IND Milestone in a sentence

  • 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.

  • Within thirty (30) days of the achievement of an IND Milestone Event (as defined in the Equity Agreement), Soligenix will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) [*****] in cash, or (ii) the IND Milestone Shares (as defined in the Equity Agreement).

  • 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.

  • The following Milestone Payments by Atossa will be due: IND Milestone: $5,000,000 for the exclusive right to review, access, and reference a Besins IND for each Additional Indication.

  • If, after the IND Milestone Event is first achieved for the first Program Antibody, Merck requests that Zymeworks undertakes additional work (a) as set forth in Section 3.10 or (b) in order to obtain scientifically and commercially viable Product, and, in the case of (b) only, subject to Zymeworks having sufficient resources and personnel to address Merck’s request, then Merck shall compensate Zymeworks for such work actually performed by Zymeworks scientists at the FTE rate of USD $[…***…].

  • The number of any shares issued in consideration for the IND Milestone Consideration Amount will be determined based on lower of (A) the average of the closing prices of our Common Stock as reported on the Nasdaq Global Market for the twenty (20) consecutive trading days prior to the IND Reference Date or(B) $2.95.

  • To the extent that the aggregate amount of IND Milestone Payments exceeds the aggregate purchase price of clinical supplies, any excess will be applied as a credit against the purchase price of any commercial supplies of Products.

  • Subsequently, the next Product (“Product No. 2”) achieves all Milestones up to and including the IND Milestone Event and then becomes a Suspended Product.

  • So long as Collingwood makes the milestone payments to Ovamed which are set forth in Sections 4.3.1 and 4.3.2 of the Sublicense (the “IND Milestone Payments”), Ovamed will give Collingwood a credit, said credit not to exceed [*******] Dollars ($[*******]), to be applied to the purchase price owed for any Units purchased for clinical supplies of Products up to the aggregate amount of the IND Milestone Payments.

  • 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 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 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 shall have the meaning set forth in Section 1.11(a)(i).
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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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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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Related to IND Milestone

  • Development Milestone is defined in Section 5.3.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • 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 8.2.1.

  • Milestone Events has the meaning set forth in Section 7.2.

  • 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 has the meaning set forth in Section 4.2.

  • 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 Notice 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 means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

  • 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 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.