Compound Failure definition

Compound Failure means, with respect to a Licensed Compound, that, due to Clinical Study results or actions taken by any Regulatory Authority after the Effective Date, it is unlikely that AbbVie will be able to, on a commercially reasonable basis, obtain Regulatory Approval of a Licensed Product in a Major Market or, once granted, it is unlikely that AbbVie will be able to maintain each Regulatory Approval in any Major Market, in each case without including in the Product Labeling a significant warning or contraindication that would significantly reduce the market value of the Licensed Product.
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Compound Failure means, with respect to a Licensed Compound, that, due to Clinical Study results or actions taken by any Regulatory Authority after the Effective Date, it is unlikely that Abbott will be able to, on a commercially reasonable basis, obtain Regulatory Approval of a Licensed Product or, once granted, it is unlikely that Abbott will be able to maintain each Regulatory Approval.
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Compound Failure means, with respect to a Licensed Compound (whether such Licensed Compound is the Initial Licensed Compound or a Backup Compound deemed to be a Licensed Compound pursuant to Section 5.10.2 following a previous Compound Failure), that, due to Clinical Study results or actions taken by any Regulatory Authority after the Effective Date, the JDC determines (subject to the dispute resolution procedures set forth in Section 13.6) it is unlikely that the Parties will be able to obtain Regulatory Approval in the European Union of a Licensed Product containing such Licensed Compound for the Renal Indication that is expected by the Parties, in good faith, on the basis of market data from a recognized provider such as IMS Health (subject to the dispute resolution procedures set forth in Section 13.6 if the Parties do not agree), to have aggregate annual Net Sales in the Major Markets in any [***] of the [***] full Calendar Years immediately following the commercial launch of such Licensed Product of at least [***] Dollars ($[***]) per Calendar Year. Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Examples of Compound Failure in a sentence

  • Compound that is then the subject of the Initial Development Plan (whether such Licensed Compound is the Initial Licensed Compound or a Backup Compound deemed a Licensed Compound pursuant to this Section 5.10.2 following a previous Compound Failure), and to provide for the Development of the Backup Compound.

  • In the event of a Compound Failure as determined under Section 5.10.2, Licensor will provide Licensee with all material Information regarding any Targeted AIMs (other than compounds that are then Licensed Compounds) Controlled by Licensor or an Affiliate with respect to which Licensor or any Affiliate is then performing or proposes to perform any pre-clinical or clinical development for any Renal Indication (each such compound, a “Backup Candidate”).

  • Internal Compound Failure Compound failures are special cases of glob- al stability and occur when a slip plane cutsthrough the retained soil, the reinforced mass, and through the face of the wall (See Surface Failures A-D on Figure 18).

  • The appointment of all corporate officers requires Board authorization In addition, the Board receives the recommendations of the Executive Compensation and Corporate Governance Committee regarding the compensation of the senior executive officers, including performance bonus plans and stock options.

  • In the event of a Compound Failure as determined under Section 5.10.2, Licensor will provide Licensee with all material Information regarding any Targeted AIMs (other than compounds that are then Licensed Compounds) Controlled by Licensor or an Affiliate with respect to which Licensor or any Affiliate is then performing or proposes to perform any pre-clinical or clinical development for any Renal Indication (each such compound, a “ Backup Candidate ”).


More Definitions of Compound Failure

Compound Failure means, with respect to a Licensed Compound (whether such Licensed Compound is the Initial Licensed Compound or a Backup Compound deemed to be a Licensed Compound pursuant to Section 5.10.2 following a previous Compound Failure), that, due to Clinical Study results or actions taken by any Regulatory Authority after the Effective Date, the JDC determines (subject to the dispute resolution procedures set forth in Section 13.6) it is unlikely that the Parties will be able to obtain Regulatory Approval in the European Union of a Licensed Product containing such Licensed Compound for the Renal Indication that is expected by the Parties, in good faith, on the basis of market data from a recognized provider such as IMS Health (subject to the dispute resolution procedures set forth in Section 13.6 if the Parties do not agree), to have aggregate annual Net Sales in the Major Markets in any [***] of the [***] full Calendar Years immediately following the commercial launch of such Licensed Product of at least [***] Dollars ($[***]) per Calendar Year.
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Related to Compound Failure

  • Supply Failure shall have the meaning ascribed to it in Section 2.8.

  • MI Failure means when an MI report: a) contains any material errors or material omissions or a missing mandatory field; or b) is submitted using an incorrect MI reporting Template; or c) is not submitted by the reporting date(including where a Nil Return should have been filed);

  • GEP Failure means Seller’s failure to produce Delivered Energy in an amount equal to or greater than the Guaranteed Energy Production amount for the applicable Performance Measurement Period.

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

  • Persistent Failure means any two (2) or more failures by the Supplier in any rolling period of twelve (12) months to comply with obligations in respect of the Contract Services under the Contract;

  • Consistent Failure means any of:

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Epidemic Failure means a series of repeating failures or defects resulting in at least a 0.5% failure rate for the same Product or Material during any twelve-month period.

  • Price Failure means, with respect to a particular date of determination, the VWAP of the Common Stock on any Trading Day during the seven (7) Trading Day period ending on the Trading Day immediately preceding such date of determination fails to exceed the Floor Price (as adjusted for stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions occurring after the date hereof). All such determinations to be appropriately adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions during any such measuring period.

  • Volume Failure means, with respect to a particular date of determination, the aggregate daily dollar trading volume (as reported on Bloomberg) of the Common Stock on the Principal Market on any Trading Day during the twenty (20) Trading Day period ending on the Trading Day immediately preceding such date of determination (such period, the “Volume Failure Measuring Period”), is less than $2,000,000 (as adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions occurring after the Subscription Date). All such determinations to be appropriately adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions during such Volume Failure Measuring Period.

  • Service Failure means a failure by the Contractor to provide the Services in accordance with any individual service level described above (measured on a monthly/quarterly/annual basis)

  • Listing Failure Event means that:

  • Transaction Failure means the failure to consummate a Business Combination within 18 months of the Effective Date (or 24 months after the Effective Date, if a letter of intent, agreement in principle or definitive agreement has been executed within 18 months after the Effective Date and the Business Combination relating thereto has not yet been consummated within such 18-month period).

  • Daily Failure Amount means the product of (x) .005 multiplied by (y) the Closing Sale Price of the Common Stock on the applicable Share Delivery Date.

  • Transaction Failure Date means the 18-month anniversary of the Effective Date (or the 24 month anniversary of the Effective Date, if a letter of intent, agreement in principle or definitive agreement has been executed within 18 months after the Effective Date and the Business Combination relating thereto has not yet been consummated within such 18-month period).

  • Service Level Failure means a failure to perform the Software Support Services fully in compliance with the Support Service Level Requirements.

  • Reporting Failure has the meaning set forth in Section 2.4.

  • Listing Failure means the situation where the Bonds have not been listed on the corporate bond list of Nasdaq Stockholm (or any other Regulated Market) within sixty (60) calendar days after the Issue Date.

  • Potential Failure to Pay means the failure by a Reference Entity to make, when and where due, any payments in an aggregate amount of not less than the Payment Requirement under one or more Obligations, without regard to any grace period or any conditions precedent to the commencement of any grace period applicable to such Obligations, in accordance with the terms of such Obligations at the time of such failure.

  • Force Majeure Failure has the meaning set forth in Section 8.1(d).

  • Allowed Delay has the meaning set forth in Section 2(c)(ii).

  • Public Information Failure shall have the meaning ascribed to such term in Section 4.3(b).

  • 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.

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

  • 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.

  • Public Information Failure Payments shall have the meaning ascribed to such term in Section 4.3(b).