REPORTING OF ADVERSE EVENTS. 12.1.1. TMC shall be fully responsible for reporting to the relevant regulatory or other competent authorities in the Territory any Adverse Event(s) which are or might be attributed to the use or application of the Compound or the Product. At ASTRAZENECA's request in writing TMC shall inform ASTRAZENECA of any Adverse Event in the country(ies) contemplated, and during the time period contemplated, by such notice.
Appears in 2 contracts
Samples: License Agreement (Medicines Co/ Ma), Option Agreement (Medicines Co /De)
REPORTING OF ADVERSE EVENTS. 12.1.1. TMC shall be fully responsible for reporting to the relevant regulatory or other competent authorities in the Territory any Adverse Event(s) which are or might be attributed to the use or application of the Compound or the Product. At ASTRAZENECA's ’s request in writing TMC shall inform ASTRAZENECA of any Adverse Event in the country(ies) contemplated, and during the time period contemplated, by such notice.
Appears in 1 contract
Samples: License Agreement (Medicines Co /De)
REPORTING OF ADVERSE EVENTS. 12.1.1. TMC shall be fully responsible for reporting to the relevant regulatory or other competent authorities in the Territory any Adverse Event(s) which are or might be attributed to the use or application of the Compound or the Product. At ASTRAZENECA's request in writing TMC shall inform ASTRAZENECA of any such Adverse Event in the country(ies) contemplated, and during the time period contemplated, by such notice.
Appears in 1 contract
Samples: License Agreement (Medicines Co /De)