Common use of Adverse Experience Reporting Clause in Contracts

Adverse Experience Reporting. Patheon shall notify Santarus promptly and not later than *** hours after it becomes aware of (a) any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE") and the severity thereof associated with the use of the Finished Product, whether or not determined to be attributable to the Finished Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Product or the continued marketing of the Finished Product in any nation or jurisdiction. Further and without limiting the foregoing, Patheon shall notify Santarus by telephone and facsimile within *** hours after Patheon first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to Santarus, or any failure of one or more batches of Finished Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Product, Santarus shall notify Patheon promptly and not later than *** hours after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party (or its Affiliates) receives a communication or directive from a Government Authority commencing or threatening seizure of Finished Product, or other removal from the market of Finished Product, such Party shall transmit such information to the other Party within *** hours of receipt.

Adverse Experience Reporting. Patheon Supplier shall notify or shall have Manufacturer notify Santarus promptly and not later than [*** *] hours after it Supplier or Manufacturer first becomes aware of (a) any information concerning any potentially serious or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE"“Adverse Experience”) and the severity thereof associated with the use of the Finished Commercial Product, whether or not determined to be attributable to the Finished Bulk Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Commercial Product or the continued marketing of the Finished Commercial Product in any nation or jurisdiction. Further and without limiting the foregoing, Patheon Supplier shall have Manufacturer notify Santarus by telephone and facsimile within [*** *] hours after Patheon Supplier or Manufacturer first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Commercial Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Commercial Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to SantarusBulk Product, or any failure of one or more batches of Finished Bulk Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Bulk Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Bulk Product, Santarus shall notify Patheon Supplier promptly and not later than [*** *] hours after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party (or its Affiliates) receives a communication or directive from a Government Authority commencing or threatening seizure of Finished Commercial Product, or other removal from the market of Finished Commercial Product, such Party shall transmit such information to the other Party within *** twenty-four (24) hours of receipt.

Adverse Experience Reporting. Patheon Manufacturer shall notify Santarus promptly and not later than *** twenty-four (24) hours after it becomes aware of (a) any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE") and the severity thereof associated with the use of the Finished Product, whether or not determined to be attributable to the Finished Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Product or the continued marketing of the Finished Product in any nation or jurisdiction. Further and without limiting the foregoing, Patheon Manufacturer shall notify Santarus by telephone and facsimile within *** twenty-four (24) hours after Patheon Manufacturer first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to Santarus, or any failure of one or more batches of Finished Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Product, Santarus shall notify Patheon Manufacturer promptly and not later than *** twenty-four (24) hours after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party (or its Affiliates) receives a communication or directive from a Government Authority commencing or threatening seizure of Finished Product, or other removal from the market of Finished Product, such Party shall transmit such information to the other Party within *** twenty-four (24) hours of receipt.

Adverse Experience Reporting. Patheon shall notify Santarus promptly and not later than [*** *] hours after it becomes aware of (a) any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE"“Adverse Experience”) and the severity thereof associated with the use of the Finished Product, whether or not determined to be attributable to the Finished Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Product or the continued marketing of the Finished Product in any nation or jurisdiction. Further and without limiting the foregoing, Patheon shall notify Santarus by telephone and facsimile within [*** *] hours after Patheon first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to Santarus, or any failure of one or more batches of Finished Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Product, Santarus shall notify Patheon promptly and not later than [*** *] hours after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party (or its Affiliates) receives a communication or directive from a Government Authority commencing or threatening seizure of Finished Product, *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. or other removal from the market of Finished Product, such Party shall transmit such information to the other Party within [*** *] hours of receipt.

Adverse Experience Reporting. Patheon shall notify Santarus promptly and not later than [* * *** hours ] after it becomes aware of (a) any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE"“Adverse Experience”) and the severity thereof associated with the use of the Finished Product, whether or not determined to be attributable to the Finished Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Product or the continued marketing of the Finished Product in any *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. nation or jurisdiction. Further and without limiting the foregoing, Patheon shall notify Santarus by telephone and facsimile within [* * *** hours ] after Patheon first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to Santarus, or any failure of one or more batches of Finished Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Product, Santarus shall notify Patheon promptly and not later than [* * *** hours ] after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party (or its Affiliates) receives a communication or directive from a Government Authority commencing or threatening seizure of Finished Product, or other removal from the market of Finished Product, such Party shall transmit such information to the other Party within [* * *** hours ] of receipt.