Common use of REPORTING OF ADVERSE EVENTS Clause in Contracts

REPORTING OF ADVERSE EVENTS. 8.1 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. 8.2 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. 8.3 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. 8.4 The Contractor’s pharmacovigilance contact for the purpose of this Article 7 is: 8.5 UNDP’s contact for the purpose of Article 7 is: ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, Procurement Specialist Global Fund/Health Implementation Support Team UNDP Geneva, Switzerland Email: ▇▇▇▇▇▇.▇▇▇▇▇▇▇@▇▇▇▇.▇▇▇ Tel: +▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇ 8.6 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. 8.1 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. 8.2 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. 8.3 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. 8.4 7.4 The Contractor’s pharmacovigilance contact for the purpose of this Article 7 is: 8.5 7.5 UNDP’s contact for the purpose of Article 7 is: ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇Marquet, Procurement Specialist Global Fund/Health Implementation Support Team UNDP Geneva, Switzerland Email: ▇▇▇▇▇▇.▇▇▇▇▇▇▇@▇▇▇▇.▇▇▇ Tel: +▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇ 8.6 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.