IND Milestone definition

IND Milestone shall have the meaning provided in Section 4.2(a).
Sample 1Sample 2Sample 3
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”.
Sample 1Sample 2
IND Milestone means the occurrence and/or the achievement of all of the following:
Sample 1

Examples of IND Milestone in a sentence

  • 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.

  • 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).

  • 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.

  • 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 $[…***…].

  • 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.

  • B20 FillAll fill is to be graded at a minimum of 1% so that it drains to the street or other approved permanent drainage system and where necessary, perimeter drainage is to be provided.

  • 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.

  • During the fourth quarter of 2020, the Company achieved the IND Milestone and paid the obligation in shares according to the calculation above.

  • No later than sixty (60) days after the IND Milestone Reference Date, in the case of the first occurrence of the IND Milestone, or sixty (60) days after the date of the first occurrence of the Phase 2 Milestone, Parent shall (i) provide written notice (a “Regulatory Milestone Statement”) to the Stockholder Representative of the occurrence of such Regulatory Milestone and (ii) subject to Article VI, pay, or cause to be paid, the corresponding Contingent Payment in accordance with Section 1.7(a).


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.
Sample 1
IND Milestone shall have the meaning set forth in Section 1.11(a)(i).
Sample 1
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.
Sample 1
IND Milestone has the meaning set forth in Section 1.8.
Sample 1
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.
Sample 1

Related to IND Milestone

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

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

  • 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 is defined in Section 5.3.

  • 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 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 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. [***]

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

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • 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 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.