Common use of Event Reporting Clause in Contracts

Event Reporting. Each Party shall be responsible for reporting all Events (as defined below) associated with the development or Commercialization of a Licensed Product in its respective territory (as to Maruishi, the Territory) to the appropriate Regulatory Authorities in its respective territory, in accordance with all Applicable Laws, and shall provide the other Party copies of all such reports promptly after filing with the Regulatory Authorities. Additionally, in the event either Party receives information regarding Events related to the use of a Licensed Product, such Party shall promptly provide the other Party with such information in accordance with the separate Safety Agreement to be entered into by the Parties promptly. For purposes of this Section 3.7, “Event” shall mean any adverse event, adverse drug reaction or medical device report, including, without limitation, malfunctions, product failure, improper or inadequate design, manufacturer labeling or user error reported during the use of the Licensed Product by or on behalf of Maruishi, its Affiliates, and customers (including, without limitation, end users purchasing any Licensed Product or using any Licensed Product purchased from any of the foregoing). Each Party shall notify the other Party immediately of any Information received regarding any threatened or pending action by any public authority that may affect or related to the safety, efficacy, or other labeling claims of any CR-845 product.

Event Reporting. Each Party shall be responsible for reporting all Events (as defined below) associated with the development Development or Commercialization of a Licensed Product in its respective territory (as to MaruishiGSL, the Territory and, as to Lipocine, outside the Territory) to the appropriate Regulatory Authorities in its respective territory, in accordance with all Applicable Laws, and shall provide the other Party copies of all such reports promptly after filing with the Regulatory Authorities. Additionally, in the event either Party receives information regarding Events related to the use of a Licensed Product, such Party shall promptly provide the other Party with such information in accordance with the separate Safety Agreement to be entered into by the Parties promptly. For purposes of this Section 3.73.6, “Event” shall mean any adverse eventLicensed Product complaint, adverse event or adverse drug reaction or medical device reportreaction, including, without limitation, including malfunctions, product failure, improper or inadequate design, manufacturer labeling labeling, quality control or user error reported during the use of the Licensed Product by or on behalf of Maruishia Party, its Affiliates, Sublicensees and customers (including, without limitation, including end users purchasing any Licensed Product or using any Licensed Product purchased from any of the foregoing). Each Party shall notify the other Party immediately of any Information received regarding any threatened or pending action by any public authority that may affect or related to the safety, efficacy, or other labeling claims of any CR-845 productLicensed Product. Without limiting the foregoing, the Parties shall negotiate in good faith and enter into a pharmacovigilance agreement consistent with this Section 3.6.