REPORTING OF ADVERSE EVENTS. The Investigator shall promptly advise the Sponsor of any serious adverse event or unanticipated adverse effect occurring during the Study, or subsequent to the completion or termination of the Study, that becomes known to him.
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.
REPORTING OF ADVERSE EVENTS. 17.1 Sublicensee shall report to Sublicensors, within forty-eight (48) hours from receipt of the information, any materially adverse event that is reported to occur as a result of use of any of the Products. Such events must be reported in as much detail as possible, whether or not there is proof of a causal connection between the events and use of the Products. A materially adverse event includes any experience relating to the Products which is reasonably regarded to be seriously detrimental to person or property in any manner. 18.9 —Reserved.
REPORTING OF ADVERSE EVENTS. Each party will give prompt notice to the other party of any information it receives regarding the safety of the Product, including any confirmed or unconfirmed information on adverse, serious, or unexpected events associated with the use of the Product (i) by telephone by the end of the next calendar day and (ii) in writing via facsimile within three calendar days after receipt of the information. Pharmion will file any reports concerning such incidents required by law or regulation in the Territory.
REPORTING OF ADVERSE EVENTS. The Parties shall report, and take other actions in relation to, adverse events with respect to each Collaboration Product that are reported or otherwise known to them in accordance with a reporting protocol that is established by the JSC for each Development and Commercialization Plan prior to the commencement of the first clinical trials of the applicable Collaboration Product.
REPORTING OF ADVERSE EVENTS. The Parties shall promptly provide each other with necessary information and data relating to adverse events associated with the Manufacture of the Product, received by or reported to the Parties from any sources in accordance with the Safety Data Exchange Agreement.
REPORTING OF ADVERSE EVENTS. 7.1 An Adverse Event is any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
REPORTING OF ADVERSE EVENTS. The investigator is responsible for reporting all AEs observed by the investigator or reported by the subject as follows in Table 5:
REPORTING OF ADVERSE EVENTS. The fully executed SDEA between the Parties is an integral part of this Agreement and shall apply to the Services under this Agreement.
REPORTING OF ADVERSE EVENTS. 7.1 Each party shall provide the other party in writing with information on serious adverse events that might be related to the Licensed Product in a manner to be agreed between both parties.
