Common use of Safety Data Exchange Agreement Clause in Contracts

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. 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. Subject to the terms of this Agreement, and no later than three (3) months prior to the initiation of the first Phase 1 Clinical TrialStudy, Ambrx Digital Diagnostics and BMS Exactus BioSolutions (under the guidance of their respective Pharmacovigilance Product Safety 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 Devices 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 Device 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 Exactus BioSolutions 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.