Common use of Safety Data Exchange Agreement Clause in Contracts

Safety Data Exchange Agreement. (a) The Parties agree to develop and commit to a SDEA that allows them to fulfill their respective regulatory and pharmacovigilance obligations relating to Adverse Experience reporting to Regulatory Authorities in accordance with Applicable Laws. Such SDEA will be completed within [***] days after the Effective Date and prior to Launch. Knight shall be responsible for the timely filing with the 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. applicable Regulatory Authority of all Adverse Experience reports in the Territory. The SDEA shall provide for the exchange of safety information between the Parties sufficient to enable each Party to comply with its legal obligations to report to the applicable Regulatory Authority, for Braeburn to comply with the Titan Agreement, and include any measures necessary for each Party to comply with Applicable Laws. Each Party shall promptly provide the other Party with copies of all such reports, analyses, summaries and all submissions to the applicable Regulatory Authority. The Adverse Experience procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in Section 5.3(b). (b) Prior to Launch, Knight will establish a system for the reporting of Adverse Experiences by patients, physicians and others that is customary for the Territory and that complies with all Applicable Laws. [***]. Knight or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, interact with Braeburn if physical or other testing of a Sublicensed Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses or summaries of its activities as may be required by Applicable Laws. Copies of such reports will be promptly provided to Braeburn. (c) All safety related reports and correspondence shall be addressed to such safety representative as may be designated by Braeburn and Knight.

Safety Data Exchange Agreement. (a) The Parties agree to develop and commit to a SDEA that allows them to fulfill their respective regulatory and pharmacovigilance obligations relating to Adverse Experience reporting to Regulatory Authorities in accordance with Applicable Laws. Such SDEA will be completed within [***] ninety (90) days after the Effective Date and prior to Launch. Knight shall be responsible for the timely filing with the 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. applicable Regulatory Authority of all Adverse Experience reports in the Territory. The SDEA shall provide for the exchange of safety information between the Parties sufficient to enable each Party to comply with its legal obligations to report to the applicable Regulatory Authority, for Braeburn to comply with the Titan Agreement, and include any measures necessary for each Party to comply with Applicable Laws. Each Party shall promptly provide the other Party with copies of all such reports, analyses, summaries and all submissions to the applicable Regulatory Authority. The Adverse Experience procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in Section 5.3(b). (b) Prior to Launch, Knight will establish a system for the reporting of Adverse Experiences by patients, physicians and others that is customary for the Territory and that complies with all Applicable Laws. [***]The costs of such reporting and of all services provided by any Third Party contractor in connection with Adverse Experiences hereunder shall be borne by Knight. Knight or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, interact with Braeburn if physical or other testing of a Sublicensed Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses or summaries of its activities as may be required by Applicable Laws. Copies of such reports will be promptly provided to Braeburn. (c) All safety related reports and correspondence shall be addressed to such safety representative as may be designated by Braeburn and Knight.

Safety Data Exchange Agreement. (a) The Parties agree to develop and commit to a SDEA that allows them to fulfill their respective regulatory and pharmacovigilance obligations relating to Adverse Experience reporting to Regulatory Authorities in accordance with Applicable Laws. Such SDEA will be completed within At least [***] days after months (or such other time period agreed by the Effective Date and prior to Launch. Knight shall be responsible for Parties) in advance of any Regulatory Approval of the timely filing with the 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. applicable Regulatory Authority of all Adverse Experience reports Product in the Territory, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will enter into a written safety data exchange agreement, which may include as additional parties Santhera or Catalyst’s other licensors if applicable, setting forth the pharmacovigilance procedures for and responsibilities of the Parties with respect to the Compound and Products, such as safety data sharing, adverse events reporting and safety signal and risk management (the “Safety Data Exchange Agreement”), which agreement shall be amended by the Parties from time to time as necessary to comply with any changes in Applicable Laws or guidance received from Regulatory Authorities. The SDEA shall Such Safety Data Exchange Agreement will provide for the receipt, investigation, recording, communication, and exchange of safety information between by the Parties sufficient of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, and other safety data, including any such information and other safety data received by either Party from a Third Party (subject to receipt of any required consents from such Third Party). All procedures and responsibilities set forth in the Safety Data Exchange Agreement shall be in accordance with, and enable the Parties to fulfill, local, national and international regulatory reporting obligations under Applicable Laws (including to the extent applicable, obligations contained in ICH guidelines). Subject to compliance with Applicable Law, each Party hereby agrees to comply with its legal respective obligations under the Safety Data Exchange Agreement (as the Parties may agree to report modify it from time to the applicable Regulatory Authority, for Braeburn time) and to cause its Affiliates and licensees and sublicensees (as applicable) to comply with the Titan Agreement, and include any measures necessary for such obligations. It is understood that each Party and its Affiliates and licensees and sublicensees (as applicable) will have the right to disclose safety data if such disclosure is reasonably necessary to comply with Applicable LawsLaws and Regulatory Authority regulations and requirements. Each Party shall promptly provide To the other Party with copies of all such reports, analyses, summaries and all submissions to extent there is any inconsistency between the applicable Regulatory Authority. The Adverse Experience procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in Section 5.3(b). (b) Prior to Launch, Knight will establish a system for the reporting of Adverse Experiences by patients, physicians and others that is customary for the Territory and that complies with all Applicable Laws. [***]. Knight or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, interact with Braeburn if physical or other testing of a Sublicensed Product appears to be reasonably required, determine the nature terms of the Adverse Experience based on data and reports it has obtainedSafety Data Exchange Agreement, once executed, and issue any reportsthe terms of this Agreement, analyses or summaries the terms of its activities as may be required by Applicable Laws. Copies of such reports will be promptly provided to Braeburnthe Safety Data Exchange Agreement shall govern. (c) All safety related reports and correspondence shall be addressed to such safety representative as may be designated by Braeburn and Knight.

Safety Data Exchange Agreement. (a) The Parties agree to develop and commit to a SDEA that allows them to fulfill their respective regulatory and pharmacovigilance obligations relating to Adverse Experience reporting to Regulatory Authorities in accordance with Applicable Laws. Such SDEA will be completed within Within [***] days after of the Effective Date Date, the Parties will negotiate and prior to Launch. Knight shall be responsible enter into one or more written agreements on Licensor’s standard form setting forth safety and pharmacovigilance procedures for the timely filing Parties with respect to the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH Licensed Products (each a “[***]Safety Data Exchange Agreement”). 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 1934Each Safety Data Exchange Agreement will describe the obligations of both Parties with respect to the coordination, AS AMENDED. applicable Regulatory Authority of all Adverse Experience reports in the Territory. The SDEA shall provide for the collection, investigation, reporting, and exchange of safety information between the Parties concerning any adverse event experienced by a subject, and the seriousness thereof, whether or not determined to be attributable to any Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) and will be sufficient to enable permit each Party and its Affiliates, licensees, or Sublicensees (as applicable) to comply with all Applicable Law (including cGLP, cGMP, and cGCP, as applicable) and its legal obligations with respect thereto, including each Party’s obligations as the owner or holder of Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for such Licensed Product either inside or outside the Territory, as applicable. Each Safety Data Exchange Agreement will also detail each Party’s responsibilities with respect to recalls and withdrawals of the Licensed Products within the Territory. If required by changes in Applicable Law (including cGLP, cGMP, and cGCP, as applicable), the Parties will make appropriate updates to each Safety Data Exchange Agreement. Each Party will comply with its respective obligations under each Safety Data Exchange Agreement and cause its Affiliates, licensees, and Sublicensees to comply with such obligations. Notwithstanding any provision to the contrary in this Agreement or any Safety Data Exchange Agreement, each Party and its Affiliates, licensees, and sublicensees will have the right to disclose information related to the safety of one or more Licensed Products to the extent that such disclosure is required for (a) such Party to comply with its legal obligations to report to the applicable Regulatory Authorityunder Applicable Law (including cGLP, for Braeburn to comply with the Titan AgreementcGMP, and include any measures necessary for each Party to comply with Applicable Laws. Each Party shall promptly provide cGCP, as applicable) or the other Party with copies of all such reports, analyses, summaries and all submissions to the applicable Regulatory Authority. The Adverse Experience procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in Section 5.3(b). (b) Prior to Launch, Knight will establish a system for the reporting of Adverse Experiences by patients, physicians and others that is customary for the Territory and that complies with all Applicable Laws. [***]. Knight or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, interact with Braeburn if physical or other testing of a Sublicensed Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses or summaries of its activities as may be required by Applicable Laws. Copies of such reports will be promptly provided to Braeburn. (c) All safety related reports and correspondence shall be addressed to such safety representative as may be designated by Braeburn and Knight.requirements of