Common use of Safety Representatives Clause in Contracts

Safety Representatives. Each Party will provide to the other the name of an appointed safety representative of the Party to whom all adverse Experiences reports and queries should be reported. The safety representative of each Party will report to the safety representative of the other Party all Adverse Experiences received in respect of a particular Development Compound as follows: (i) Without regard to investigator-ascribed causality, any and every Adverse Experience which is fatal or life threatening or which is a serious Adverse Experience as defined in clinical protocols shall be reported by the receiving party to the other Party by facsimile within one (1) working day of receipt by the receiving Party's safety representative; (ii) A summary written report of all non-serious Adverse Experiences shall be submitted by the receiving Party to the other Party on a monthly basis by the receiving Party's safety representative; (iii) A summary written report of all Adverse Experiences, serious and non-serious shall be provided by each Party to the other Party, on an annual basis, indicating those cases which have previously been reported to the other Party; (iv) Any information which changes an Adverse Experience from non-serious to serious shall be reported to the other Party's safety representative within one (1) working day of receipt of such information by the receiving Party's safety representative; (v) Further information received by a Party on any serious Adverse Experience shall be reported to the other Party's safety representative within ten (10) working days of receipt of such information by the receiving Party's safety representative; and (vi) Treatment codes shall be included in all reports for any Adverse Experiences that must be reported to European regulatory authorities.

Safety Representatives. Each Party will provide to the other the name of an appointed safety representative of the Party to whom all adverse Experiences reports and queries should be reported. The safety representative of each Party will report to the safety representative of the other Party all Adverse Experiences received in respect of a particular Development Compound as follows: : (i) Without regard to investigator-ascribed causality, any and every Adverse Experience which is fatal or life threatening or which is a serious Adverse Experience as defined in clinical protocols shall be reported by the receiving party to the other Party by facsimile within one (1) working day of receipt by the receiving Party's safety representative; ; (ii) A summary written report of all non-serious Adverse Experiences shall be submitted by the receiving Party to the other Party on a monthly basis by the receiving Party's safety representative; ; (iii) A summary written report of all Adverse Experiences, serious and non-serious shall be provided by each Party to the other Party, on an annual basis, indicating those cases which have previously been reported to the other Party; ; (iv) Any information which changes an Adverse Experience from non-serious to serious shall be reported to the other Party's safety representative within one (1) working day of receipt of such information by the receiving Party's safety representative; ; (v) Further information received by a Party on any serious Adverse Experience shall be reported to the other Party's safety representative within ten (10) working days of receipt of such information by the receiving Party's safety representative; and and (vi) Treatment codes shall be included in all reports for any Adverse Experiences that must be reported to European regulatory authorities.