Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other reports or information received by POZEN indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction, illness or injury is caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by POZEN to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any such written reports, and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to POZEN upon conclusion of such investigation. POZEN will copy Nycomed on all correspondence with regulatory authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products or Nycomed Products.
Appears in 2 contracts
Samples: Development, Option and License Agreement, Development, Option and License Agreement (Pozen Inc /Nc)
Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other reports or information received by POZEN Buyer indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction, illness or injury is caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by POZEN Buyer to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any such written reports, and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to POZEN Buyer upon conclusion of such investigation. POZEN Buyer will copy Nycomed on all correspondence with regulatory authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products or Nycomed Products.
Appears in 1 contract
Samples: Development, Option and License Agreement (Pozen Inc /Nc)
Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other reports or information received by POZEN indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction, illness or injury is caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by POZEN to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any such written reports, and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to POZEN upon conclusion of such investigation. POZEN will copy Nycomed on all correspondence with regulatory authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products or Nycomed Products. *** Portion for which confidential treatment requested.
Appears in 1 contract
Samples: Development, Option and License Agreement (Pozen Inc /Nc)