Safety Data Exchange Agreement. The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting. Such SDEA will be completed within ninety (90) days after the Effective Date.
Appears in 7 contracts
Samples: Distribution, License and Supply Agreement (Synergy CHC Corp.), Intellectual Property License Agreement (Synergy CHC Corp.), Distribution, License and Supply Agreement (Synergy CHC Corp.)
Safety Data Exchange Agreement. The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence pharmacovigilance obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting. Such SDEA will be completed within ninety (90) days [**] after filing of the Effective Datefirst Regulatory Submission in the Territory.
Appears in 2 contracts
Samples: Distribution, License and Supply Agreement (Onconova Therapeutics, Inc.), License and Supply Agreement (Onconova Therapeutics, Inc.)
Safety Data Exchange Agreement. The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting, including any RMP required by any Governmental Authority inside or outside the Territory. Such SDEA will be completed within ninety (90) days after the Effective Date.
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