REPORTING OF ADVERSE EVENTS Sample Clauses

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. 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. 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. 12.1.2. ASTRAZENECA shall be fully responsible for reporting to the relevant regulatory or other competent authorities in any country outside the Territory or for which the license to TMC hereunder has been terminated any Adverse Event(s) which are or might be attributed to the use or application of the Compound or the Product. At TMC's request in writing ASTRAZENECA shall inform TMC of any Adverse Event in the country(ies) contemplated, and during the time period contemplated, by such notice. For the avoidance of doubt ASTRAZENECA may appoint any Affiliate(s) or sub-licensee(s) carrying out the marketing of the Product in the country concerned to fulfil any such obligation as stated hereunder. 12.1.3. Without limiting what is stated in Article 12.1, the Parties shall at an appropriate point of time during development of the Product jointly establish any such Adverse Event reporting procedures, including, but not limited to, any agreement regarding safety data exchange, as may be required or useful.

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. 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. 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. 7.2 To the extent possible with regards to sharing information, UNDP will pass on to the Contractor any and all inquiries and requests for medical information and documentation and any complaints which UNDP may receive with respect to the Goods. The Contractor will be responsible for the provision of such medical information and documentation in its own name. 7.3 Each Party agrees to notify the other as soon as reasonably possible in the event of any information being directly sent to and received by its responsible staff as to the occurrence of any Adverse Events with respect to use of the Product. 7.4 The Contractor’s pharmacovigilance contact for the purpose of this Article 7 is: 7.5 UNDP’s contact for the purpose of Article 7 is: Xx. Xxxxxx Marquet, Procurement Specialist Global Fund/Health Implementation Support Team UNDP Geneva, Switzerland Email: xxxxxx.xxxxxxx@xxxx.xxx Tel: +00 00 000 00 00 7.6 In addition, the Contractor will periodically (3-monthly) contact UNDP to ascertain whether any Adverse Events have been directly sent to and received by relevant staff in UNDP as described above.

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. 12.1.2. ASTRAZENECA shall be fully responsible for reporting to the relevant regulatory or other competent authorities in any country outside the Territory or for which the license to TMC hereunder has been terminated any Adverse Event(s) which are or might be attributed to the use or application of the Compound or the Product. At TMC's request in writing ASTRAZENECA shall inform TMC of any Adverse Event in the country(ies) contemplated, and during the time period contemplated, by such notice. For the avoidance of doubt ASTRAZENECA may appoint any Affiliate(s) or sub-licensee(s) carrying out the marketing of the Product in the country concerned to fulfil any such obligation as stated hereunder. License Agreement - The Medicines Company

REPORTING OF ADVERSE EVENTS. All AEs will be recorded from initiation of study drug treatment, during treatment, and through EOS, regardless of the causal relationship to the investigational product. All AEs, whether believed by the Investigator to be related or unrelated to the investigational product, must be documented in the patient’s medical records/source documents, in accordance with the Investigator’s normal clinical practice and on the AE CRF. Each AE is to be evaluated for duration, intensity, frequency, seriousness, outcome, other actions taken, and relationship to the investigational product.

REPORTING OF ADVERSE EVENTS. 16.1 CATALINA shall report to WESTINGHOUSE within seventy-two (72) 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.