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 in no event later than 60 sixty (60) days thereafter, Braeburn . ENDO and Camurus shall ZARS will develop and agree upon safety data exchange procedures governing in a separate and detailed Safety Agreement. ZARS shall use commercially reasonable efforts to have any relevant Affiliates and other licensees become a party to such Safety Agreement. Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events relating to Licensed Products (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 or any other safety problem of any significance, hereafter “Adverse Events”), 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 Guidelinesguidelines. 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 shall inform the other Party 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 ZARS 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 ENDO will ensure that its Affiliates, Sublicensees Affiliates and licensees, as applicable, sublicensees comply with all such reporting obligations, and ZARS will ensure that its Affiliates and other licensees comply with all 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 1934In addition, AS AMENDED.ENDO

Reporting Adverse Events. Promptly following 6.4.1 Subject to 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 PVA (as defined further described in Section 6.4.2 below) and upon 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 eventexecution thereof, each Party shall inform be responsible for all pharmacovigilance activities associated with Licensed Molecules and Licensed Products in such Party’s Territory, including submitting all reports required to be submitted in order to maintain any IND for Licensed Molecules and Licensed Products filed by or under the authority of such Party, and/or any Regulatory Approvals granted for Licensed Molecules and Licensed Products, in such Party’s Territory (including the timely reporting of adverse drug experiences, product quality, product complaints and safety data relating to Licensed Molecules and/or Licensed Products in the Territory). Each Party shall notify the other Party in writing with respect to any material changes or material issues that may arise in connection with any IND for a Licensed Product filed by or under the authority of such Party, and/or any Adverse Event of which it becomes aware Regulatory Approvals for a Licensed Product, in a timely manner commensurate with any country or administrative region within such first Party’s respective Territory no later than the seriousness of the Adverse Event. Braeburn or its Sublicensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities relevant time period set forth 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 TerritoryPVA. Each Party shall ensure that its AffiliatesAffiliates (and, Sublicensees and licenseesin the case of RAPT, as applicable, Sublicensees) 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 “[***]. Each Party shall cooperate with and assist the other Party, as provided in the PVA, to enable the other Party to meet its regulatory reporting requirements [***]. 6.4.2 Within [***] after the Effective Date, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement (the “PVA”) on terms no less stringent than those required by Applicable Law and consistent with applicable terms and conditions of this Agreement, which pharmacovigilance agreement shall: (a) provide detailed procedures regarding the maintenance of core safety information and the prompt exchange of safety data relating to Licensed Molecules and Licensed Products throughout both Parties’ Territories within appropriate time frames and in an appropriate format to enable each Party to meet its expedited and periodic regulatory reporting requirements; and (b) ensure compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis and all requirements under Applicable Law for the management of safety data. A COMPLETE VERSION OF For clarity, the Parties acknowledge that Clinical Trials of a Licensed Product have already been initiated by Jemincare as of the Effective Date. The PVA shall apply to any Clinical Trials initiated by either Party prior to execution of the PVA, to the extent applicable at the time of execution. Each Party shall and shall cause its Affiliates (and, in the case of RAPT, Sublicensees) to: (x) provide processed pharmacovigilance cases from all Clinical Trials conducted by or on behalf of such Party for the Licensed Molecule and/or the Licensed Product, to the other Party in accordance with the terms and conditions of the PVA; (y) to collect all Adverse Events reports in accordance with Applicable Law and the protocol for all Clinical Trials conducted by or on behalf of such Party for the Licensed Molecule and/or the Licensed Product, and (z) to promptly and in accordance with the PVA forward to the other Party relevant information, such as the processed suspected unexpected serious adverse CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT DOCUMENT, MARKED BY [***], HAS BEEN FILED SEPARATELY WITH OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE SECRETARY OF TYPE THAT THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. reaction (SUSARs), AS AMENDEDany serious Adverse Events (SAEs), and any pregnancy related reports that such Party or its Affiliates (and, in the case of RAPT, Sublicensees) may become aware of (in any event, within the relevant time period set forth in the PVA) that are required to be reported under Applicable Law or under the protocol for all Clinical Trials conducted by or on behalf of such Party for the Licensed Molecule and/or the Licensed Product. All such information, data and documentation exchanged between the Parties subject to this Section 6.4 (Reporting; Adverse Event) and any PVA entered into by Parties pursuant to this Agreement shall be treated as Confidential Information of both Parties under this Agreement, and each Party shall have the right to provide such information, data and documentation to its Affiliates (or, in the case of RAPT, to Sublicensees, and, in the case of Jemincare, to its licensees of the Licensed IP in the Field) on terms that are consistent with the confidentiality provisions in this Agreement.

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.

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.