New Indication Milestone Event definition

New Indication Milestone Event means for a given Oragenics Product, the approval of a Supplemental FDA Application with the FDA (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of an Oragenics Product other than the current regulatory-approved indication for the respective Oragenics Product. Notwithstanding the foregoing and in order to incentivize Oragenics to pursue new indications for the product AG013 in parallel with the existing indication (as such existing indication is described in Investigational Drug Application no. 13995) for product AG013, the New Indication Milestone Event will be deemed not to have occurred if the filed regulatory package under the prior sentence relies upon one or more human clinical trials for the specific new indication, which clinical trial(s) were conducted simultaneously and in parallel with human clinical trials underpinning the first-approved indication for AG013. For the avoidance of doubt and clarification purposes, any occurrence of the New Indication Milestone Event shall not also be deemed the occurrence of the New Product Milestone Event or vice versa.
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New Indication Milestone Event means the filing by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, of a Supplemental FDA Application with the FDA (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application seeks approval of an indication for use of an Oragenics Product for a use other than the current regulatory-approved indication for the respective Oragenics Product. Notwithstanding the foregoing and in order to incentivize Oragenics to pursue new indications for the product AG013 in parallel with the existing indication (as such existing indication is described in Investigational Drug Application no. 13995) for product AG013, the New Indication Milestone Event will be deemed not to have occurred if the filed regulatory package under the prior sentence relies upon one or more human clinical trials for the specific new indication, which clinical trial(s) were conducted simultaneously and in parallel with human clinical trials underpinning the first-approved indication for AG013. For the avoidance of doubt and clarification purposes, any occurrence of the New Indication Milestone Event shall not also be deemed the occurrence of the New Product Milestone Event or vice versa.
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New Indication Milestone Event means for a given Oragenics Product, the approval of a Supplemental FDA Application with the FDA (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of an Oragenics Product other than the current regulatory-approved indication for the respective Oragenics Product. For the avoidance of doubt and clarification purposes, any occurrence of the New Indication Milestone Event shall not also be deemed the occurrence of the New Product Milestone Event or vice versa.
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Examples of New Indication Milestone Event in a sentence

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More Definitions of New Indication Milestone Event

New Indication Milestone Event means the filing by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, of a Supplemental FDA Application with the FDA (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application seeks approval of an indication for use of an Oragenics Product for a use other than the current regulatory- approved indication for the respective Oragenics Product. Notwithstanding the foregoing and in order to incentivize Oragenics to pursue new indications for the product AG013 in parallel with the existing indication (as such existing indication is described in Investigational Drug Application no. 13995) for product AG013, the New Indication Milestone Event will be deemed not to have occurred if the filed regulatory package under the prior sentence relies upon one or more human clinical trials for the specific new indication, which clinical trial(s) were conducted simultaneously and in parallel with human clinical trials underpinning the first-approved indication for AG013. For the avoidance of doubt and clarification purposes, any occurrence of the New Indication Milestone Event shall not also be deemed the occurrence of the New Product Milestone Event or vice versa.
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Related to New Indication Milestone Event

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

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

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

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

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

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

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

  • 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 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.

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

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

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

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

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • 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 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.

  • 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 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.

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

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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 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.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • 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.