Common use of Reporting Adverse Events Clause in Contracts

Reporting Adverse Events. Promptly following the Effective Date but not later than 60 days thereafter, Braeburn and Camurus shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as defined in the then current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall be promptly updated if required by changes in legal requirements or by agreement between the Parties. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory and Camurus or its licensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Camurus Territory. Each Party shall ensure that its Affiliates, Sublicensees and licensees, as applicable, comply with such reporting obligations. Each Party shall designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Reporting Adverse Events. Promptly following Within [***] days of the Effective Date but not later than 60 days thereafterDate, Braeburn Endo and Camurus shall Durect will develop and agree upon safety data exchange procedures governing which will be set forth in a separate and detailed safety agreement. Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to the Product (as defined in the then current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, Guidelines and any other relevant regulations or regulatory guidelines guidelines) or any other safety problem of any significancesignificance (each such adverse event or problem, hereafter an “Adverse EventsEvent”), and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelinesguidelines. The safety data exchange procedures shall will be promptly updated if required by changes in legal requirements or by agreement between the Parties. The safety agreement shall also require Durect or its designee to maintain a global safety database with respect to the Product. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall Endo will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory in accordance with the appropriate laws and Camurus regulations of the relevant countries and authorities, and Durect, or its licensees shall licensees, will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Camurus Durect Territory. Each Party shall Endo will ensure that its Affiliates, Affiliates and Sublicensees and licensees, as applicable, comply with all such reporting obligations, and Durect will ensure that its Affiliates and licensees comply with all such reporting obligations. Each Party shall will designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED* Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC.

Reporting Adverse Events. Promptly following the Effective Date but not later than 60 days thereafter(a) Upon GSK’s request, Braeburn GSK and Camurus shall ViroPharma will develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as defined in the then current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality pregnancies, (where such pregnancy reports are received) and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees Party to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall will be promptly updated if required by changes in legal requirements or by agreement between the Parties. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall ViroPharma will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory Field and Camurus in the Territory, including the FDA and EMEA, in accordance with the applicable laws and regulations of the relevant countries and authorities. ViroPharma will ensure that its Affiliates comply, and its applicable agreements with its Sublicensees require such Sublicenees to comply, with all such reporting obligations. To the extent permitted by applicable law or its licensees shall required by relevant regulatory authorities, GSK will be responsible for reporting all Adverse Events related to Products developed or commercialized for any indication outside the appropriate regulatory authorities Field or in the countries in Field but outside of the Camurus Territory. Each Party shall ensure that its Affiliates, Sublicensees and licensees, as applicable, comply with such reporting obligations. Each Party shall will designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934To the extent required by GSK’s Safety Board after the occurrence of any serious Adverse Events, AS AMENDEDGSK may terminate any pending or ongoing clinical trials of the Products; provided, however, that ViroPharma shall have the opportunity to present at, and participate in, the relevant portion of a meeting of GSK’s Safety Board where such potential termination of a ViroPharma clinical trial is being discussed prior to GSK’s Safety Board making any such decision to terminate any pending or ongoing clinical trials of the Products, and furthermore any such termination by GSK must be done in good faith. (b) This Section 5.5 shall have no effect until GSK or its Affiliates or sublicensees initiate development or commercialization of the GSK Compounds outside the Field in the Territory, or outside the Territory, and will be effective from the date such development or commercialization activities are commenced and will continue to be effective until the a date which is five (5) years from the date that GSK decides to cease such development or commercialization activities with respect to such GSK Compounds.

Reporting Adverse Events. Promptly following the Effective Date but not in no event later than 60 sixty (60) days thereafter, Braeburn ZARS shall facilitate communications between TALISKER and Camurus shall ZARS’ partner outside the Territory so that they can develop and agree upon safety data exchange procedures governing in a separate and detailed Safety Agreement between them. Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as such term is defined in the then then-current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significanceguidelines, and hereafter “Adverse Events”)) relating to Licensed Products, product quality and product complaints involving Adverse Events, sufficient to permit each Partyparty, its Affiliates, Sublicensees sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall will be promptly updated if required by changes in legal requirements or by agreement between the Partiesparties. In any event, each Party party to the Safety Agreement shall inform the other Party party and ZARS of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall TALISKER will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory in accordance with the appropriate laws and Camurus regulations of the Territory, and ZARS’ partner outside the Territory or its other licensees shall will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in outside the Camurus Territory. Each Party shall TALISKER will ensure that its Affiliates, Sublicensees Affiliates and licensees, as applicable, sublicensees comply with all such reporting obligations, and ZARS’ partner will ensure that it and its Affiliates and other licensees comply with all such reporting obligations. Each Party shall party to the Safety Agreement will designate a safety liaison to be responsible for communicating with the other Party party and ZARS regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.