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.
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Examples of Compound Failure in a sentence

  • 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”).

  • 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 ”).


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. 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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