Common use of Warning Letters Clause in Contracts

Warning Letters. BI RCV shall notify Sophiris if it receives any warning letters, non-compliance letters or other notifications from the EMA, or FDA 483s * ***Confidential Treatment Requested BI RCV Contract No: 39242 12 / 88 Execution copy Warning Letters, FDA non-compliance letters, or similar notifications from the FDA or any other Health Authority concerning or impacting Drug Substance and/or Product, or if BI RCV receives notification of any planned or unplanned inspection directed or applicable to Drug Substance and/or Product during the term of this Agreement.

Warning Letters. BI RCV shall notify Sophiris if it receives any warning letters, non-compliance letters or other notifications from the EMA, or FDA 483s * ***Confidential Treatment Requested BI RCV Contract No: 39242 12 / 88 Execution copy Confidential Warning Letters, FDA non-compliance letters, or similar notifications from the FDA or any other Health Authority concerning or impacting Drug Substance and/or Product, or if BI RCV receives notification of any planned or unplanned inspection directed or applicable to Drug Substance and/or Product during the term of this Agreement.

Warning Letters. BI RCV shall notify Sophiris if it receives any warning letters, non-compliance letters or other notifications from the EMA, or FDA 483s * ***Confidential Treatment Requested BI RCV Contract No: 39242 12 / 88 Execution copy Warning Letters, FDA non-compliance letters, or similar notifications from the FDA or any other Health Authority concerning or impacting Drug Substance and/or Product, or if BI RCV receives notification of any planned or unplanned inspection directed or applicable to Drug Substance and/or Product during the term of this Agreement.