Common use of Notification of significant quality issues Clause in Contracts

Notification of significant quality issues. As set forth in the Quality Agreements, the Parties shall notify each other of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation relating to the Product and/or Drug Substance for use or sale in the Territory. Auxilium agrees to inform Asahi on all quality decisions regarding any OOS result or major process deviations involving the Bulk Product and/or Drug Substance.

Notification of significant quality issues. As set forth in the Quality Agreements, the Parties shall notify each other of the occurrence of a confirmed out-of of-specification or out-of-trend (“OOS”) or out-of-trend (“OOT”) result or major process deviation relating to the Product and/or Drug Substance for use or sale in the Territory. Auxilium agrees The Parties agree to inform Asahi consult on all quality decisions regarding any OOS or OOT result or major process deviations involving the Bulk Product, and/or Finished Product and/or Drug Substancethat is intended for the Territory.

Notification of significant quality issues. As set forth in the Quality Agreements, the Parties shall notify each other of the occurrence of a confirmed out-of of-specification or out-of-trend (“OOS”) result or major process deviation relating to the Product and/or Drug Substance for use or sale in the Territory. Auxilium agrees The Parties agree to inform Asahi consult on all quality decisions regarding any OOS result or major process deviations involving the Bulk Drug Product and/or Drug SubstanceSubstance that is intended for the Territory.

Notification of significant quality issues. As set forth in the Quality AgreementsAgreement (including on timing set forth therein), the Parties shall notify each other of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation relating to the Bulk Product and/or Drug Substance for use whether inside the Territory or sale in outside the Territory. Auxilium agrees The Parties agree to inform Asahi consult on all quality decisions regarding any OOS result or major process deviations involving the Bulk Product and/or Drug SubstanceProduct.