Adverse Reaction Reporting. Each Party shall keep the other Party informed of information in or coming into its possession or control concerning side effects, injury, toxicity or sensitivity reaction and incidents of severity thereof associated with commercial and clinical uses, studies, investigations or tests of each Product in the Territories, whether or not determined to be attributable to the Product. SuperGen shall be responsible for filing with the FDA, as required pursuant to 21 C.F.R. Sec. 314.80, any adverse reaction reports that it receives. Xxxxxx shall be responsible for filing with the appropriate regulatory authorities in the International Territory, as required, adverse reaction reports that it receives. Within four (4) months of the Effective Date, the respective pharmacovigilance groups of SuperGen and Xxxxxx shall enter into a separate agreement covering adverse event information exchange relating to the Product.
Appears in 4 contracts
Samples: Sales, Distribution, and Development Agreement, Sales, Distribution, and Development Agreement (Abbott Laboratories), Sales Contracts (Abbott Laboratories)
