Safety Data Exchange Agreement. The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting. Such SDEA will be completed within ninety (90) days after the Effective Date.
Safety Data Exchange Agreement. Subject to the terms of this Agreement, and no later than three (3) months prior to the initiation of the first Phase 1 Clinical Trial, Ambrx and BMS (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall enter into a written agreement setting forth the responsibilities of the Parties to protect patients and promote their well-being in connection with the use of the Compounds and Products (the “Safety Data Exchange Agreement” or “SDEA”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) and regulatory submission of Adverse Event reports, reports of exposure during pregnancy, and any other information concerning the safety of any Compound or Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill local and international regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. BMS shall have the right to make the final decision with respect to any Adverse Event filing with a Regulatory Authority with respect to ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. such Product in the event of a dispute and where a decision must be made in order to comply with applicable time filing requirements.
Safety Data Exchange Agreement. As soon as reasonably practicable after the Effective Date, but in no event later than 90 days after delivery of the Continuation Notice, the pharmacovigilance departments of both Parties shall meet and agree on a safety data exchange agreement (“Safety Data Exchange Agreement”).
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).
Safety Data Exchange Agreement. The Parties shall conduct in good faith and agree upon a safety data exchange agreement, the agreement setting forth the safety information required to be shared by each Party and the schedule for the sharing of such safety information and other appropriate procedures and matters, as detailed in Exhibit G. *** = 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.
Safety Data Exchange Agreement. Upon the Signing Date, and subject to Section 17.10, the Parties shall enter into the SDEA.
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 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).
Safety Data Exchange Agreement. On the Effective Date, the Parties shall enter into a safety data exchange agreement in the form agreed upon by the Parties (“SDE Agreement”).
Safety Data Exchange Agreement. Within [***] ([***]) [***] of the Effective Date, but in any event prior to commencement of any Clinical Trials with respect to the Licensed Product in the Territory, the Parties will in good faith negotiate and finalize a separate safety data exchange agreement (the “Pharmacovigilance Agreement”), the terms of which shall set forth the obligations, procedures and timelines for Hansoh to report information (such as the occurrence of adverse events and serious adverse events) observed in connection with the Licensed Product in order to enable Viela to comply with its safety reporting obligations to Regulatory Authorities in and outside the Territory. Prior to the execution of the Pharmacovigilance Agreement, Hansoh shall promptly notify Viela of any information observed in connection with the Licensed Product necessary to enable Viela to comply with its safety reporting obligations to Regulatory Authorities in and outside the Territory. Any serious adverse events would be reported to Viela within [***] after their occurrence. Viela shall maintain the global safety database for the Licensed Product, which shall include adverse events and other information relating to the safety of the Licensed Product. Upon reasonable advanced request by Hansoh, Viela shall make the data maintained in the global safety database accessible and available to Hansoh in the form in which such data is then-currently maintained by Viela. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Safety Data Exchange Agreement. Without limitation of Section 5.5, the Parties shall, as soon as practical following the Effective Date, negotiate in good faith and enter into a safety data exchange agreement, which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions or other adverse events (including Adverse Events) sufficient to permit each Party to comply with its regulatory and other legal obligations within applicable timeframes.
