Adverse Drug Reaction Reports. NOVACEA shall maintain a system for monitoring, investigating and following up on adverse reaction reports received by it involving the Finished Product. If either party becomes aware that the Finished Product contains a defect which could or did cause death or injury, each party shall immediately by FAX and telephone provide the other with a complete (where required by law) description of all relevant details known to such party concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA, except that notification by NOVACEA to PLANTEX shall be required only in those instances where such defect relates to or appears to relate to the API. NOVACEA will be responsible for preparing adverse drug reaction reports, administering adverse drug reaction files relating to the API and filing all such reports with FDA, at its sole expense.
Adverse Drug Reaction Reports. D-NOVO shall maintain a system for monitoring, investigating and following up on adverse reaction reports received by it involving the Finished Product. If either party becomes aware that the Finished Product contains a defect which could or did cause death or injury, each party shall immediately by FAX and telephone provide the other with a complete (where required by law) description of all relevant details known to such party concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA, except that notification by D-NOVO to PLANTEX shall be required only in those instances where such defect relates to or appears to relate to the API. D-NOVO will be responsible for preparing adverse drug reaction reports, administering adverse drug reaction files relating to the API and filing all such reports with FDA, at its sole expense.
Adverse Drug Reaction Reports. BLP shall establish a system for monitoring, investigating and following-up on adverse reaction reports involving the Drug Product Processed by BLP under this Agreement. If either party becomes aware that the Drug Product Processed by BLP contains a defect which could or did cause death or injury, each party shall immediately by FAX and telephone provide the other with a complete written description of all relevant details known to such party concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA. BLP will be responsible for preparing adverse drug reaction reports, administering adverse drug reaction files relating to the Drug Product and filing all such reports with FDA, at its sole expense, with respect to Drug Product Processed by BLP under this Agreement. The obligations of BLP under this Section 6.2 with respect to a particular Drug Product shall terminate at such time as BLP is no longer entitled to market and sell such Drug Product unless and to the extent otherwise required by applicable laws, rules or regulations.
Adverse Drug Reaction Reports. BLP shall establish a system for ----------------------------- monitoring, investigating and following-up on adverse reaction reports involving the Drug Product Processed by BLP under this Agreement. If either party becomes aware that the Drug Product Processed by BLP contains a defect which could or did cause death or injury, each party shall immediately by FAX and telephone provide the other with a complete written description of all relevant details known to such party concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the appropriate Regulatory Authority. BLP and its distributors and subdistributors will be responsible for preparing adverse drug reaction reports, administering adverse drug reaction files relating to the Drug Product and filing all such reports with the appropriate Regulatory Authorities, at its sole expense, with respect to Drug Product Processed by BLP under this Agreement. The obligations of BLP under this Section 5.2 with respect to a particular Drug Product shall terminate at such time as BLP is no longer entitled to market and sell such Drug Product unless and to the extent otherwise required by applicable Regulatory Authorities and Regulatory Acts.
Adverse Drug Reaction Reports. If either Party becomes aware that the API contains a defect which could or did cause death or injury, such Party shall immediately by FAX and telephone provide the other with a complete (where required by law) description of all relevant details known to such Party concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA. NEOPROBE will be responsible for preparing adverse drug reaction reports, administering adverse drug reaction files relating to the API purchased hereunder and filing all such reports with FDA, at its sole expense.
