Common use of Safety Data Reporting Clause in Contracts

Safety Data Reporting. (a) Each Party shall keep the other Party informed about any adverse drug reactions such Party becomes aware or is informed about regarding the use of a Licensed Product. As between the Parties, Servier shall be responsible for reporting all adverse drug reactions/experiences to the appropriate regulatory authorities in countries in the Servier Territory, and MacroGenics shall be responsible for reporting all adverse drug reactions/experiences to the appropriate regulatory authorities in the MacroGenics Territory, in accordance with the appropriate laws and regulations of the relevant countries and authorities. Servier shall ensure that its Affiliates and Sublicensees comply with such reporting obligations in the Servier Territory and *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. MacroGenics shall ensure that its Affiliates and sublicensees (other than Servier and its Sublicensees) comply with such reporting obligations in the MacroGenics Territory. These reporting obligations shall apply to other adverse events as described in the SDEA Agreement, including adverse events occurring from product overdose or from product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological action, or laboratory abnormality which is, or is thought by the reporter, to be serious or associated with relevant clinical signs or symptoms.

Safety Data Reporting. (a) Each Party shall keep the other Party informed about any adverse drug reactions reactions/experiences (as defined in the SDEA Agreement) of which such Party becomes aware or is informed about regarding the use of a ***Licensed ProductProduct in the MacroGenics Territory or the ***Licensed Territory. As between the Parties, Servier Gilead shall be responsible for reporting all such adverse drug reactions/experiences to the appropriate regulatory authorities Regulatory Authorities in countries in the Servier ***Licensed Territory, and MacroGenics shall be responsible for reporting all such adverse drug reactions/experiences to the appropriate regulatory authorities Regulatory Authorities in the MacroGenics TerritoryTerritory for the ***Licensed Program, in each case in accordance with the appropriate laws and regulations Laws of the relevant countries and authorities. Servier Gilead shall ensure that its Affiliates and Sublicensees comply with such reporting obligations in the Servier ***Licensed Territory and *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. MacroGenics shall ensure that its Affiliates and sublicensees (other than Servier Gilead and its Sublicensees) comply with such reporting obligations in the MacroGenics Territory. These reporting obligations shall apply to other adverse events with respect to ***Licensed Products as described in the SDEA Agreement, including adverse events occurring from product overdose or from product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological action, or laboratory abnormality which is, or is thought by the reporter, to be serious or associated with relevant clinical signs or symptoms.