Audits for Cause Sample Clauses

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Audits for Cause. In addition to the periodic audits referred to in the previous Section, in the event: (a) the Regulatory Bodies schedule a regulatory inspection of the Facility in which the API is Manufactured; (b) HOVIONE receives a “Warning Letter” or Form 483 Observations from the FDA (or a similar correspondence from any applicable Regulatory Bodies) relating to the Manufacture of the API by HOVIONE or compliance with cGMP’s at the Facility where the Manufacturing, or other activities related to the API occurs; (c) NABRIVA has rejected a shipment of API for failure to meet Specifications; or (d) NABRIVA otherwise has reasonable concern regarding the quality or Manufacturing of API supplied by HOVIONE, NABRIVA shall have the right to conduct additional audits in respect of API according to the terms specified hereof. The audit for cause shall be subject to at least [**] prior written notice.
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Audits for Cause. Notwithstanding the foregoing, the Licensee shall have the right to conduct additional audits ([***]) for cause ([***]), to the extent such audits relate to (i) Manufacturing and supply of the Licensed Compound or Licensed Products or (ii) the global safety database and pharmacovigilance activities, in each case ((i)-(ii)), for the purpose of verifying compliance with (A) Applicable Laws, (B) quality standards and (C) the terms of this Agreement, the Clinical Supply Agreement, the Commercial Supply Agreement and the PVA. For-cause audits shall be subject to prior written notice to IDEAYA of at least [***], unless otherwise agreed by the Parties. [***]
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Audits for Cause. Audits for cause shall include, but not be limited to, these reasons: (i) quality and compliance reasons; and/or (ii) namely the conditions that justify the allocation of Products during a short supply period.
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Audits for Cause. Requirements are addressed as part of the Quality Agreement.
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Related to Audits for Cause

  • Termination for Cause If Vendor fails to materially perform pursuant to the terms of this Agreement, TIPS shall provide written notice to Vendor specifying the default. If Vendor does not cure such default within thirty (30) days, TIPS may terminate this Agreement, in whole or in part, for cause. If TIPS terminates this Agreement for cause, and it is later determined that the termination for cause was wrongful, the termination shall automatically be converted to and treated as a termination for convenience.