Common use of Safety Data Exchange Clause in Contracts

Safety Data Exchange. The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of the Combined Therapy. Subject to the terms of this Agreement, within [ * ] or [ * ] after the full execution of this Agreement, or as soon as practicable subsequent to the full execution date, as agreed to by the Parties and prior to dosing the first study patient in a Combined Therapy Trial, Exelixis and BMS (under the guidance of their Pharmacovigilance Departments, or equivalent thereof) shall execute a written pharmacovigilance agreement (“Pharmacovigilance Agreement”) to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations. Such Pharmacovigilance Agreement shall (a) provide that the Conducting Party shall hold and be responsible for the maintenance of the Global Safety Database for the Combined Therapy and safety reporting for the Combined Therapy, and shall lead all pharmacovigilance activities for the Combined Therapy, and (b) include guidelines and procedures acceptable to the Parties for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports, pregnancy reports, and any other information concerning the safety of the Combined Therapy arising from or related to the use of the BMS Compound(s) and Exelixis Compound in the Combined Therapy Trial consistent with Applicable Law. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in the Pharmacovigilance Agreement, the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole pharmacovigilance responsibility for its Compound(s) subject to all Applicable Law. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as related to the exchange and reporting of safety information associated with use of the products in a Combined Therapy Trial as well as product safety surveillance.

Safety Data Exchange. The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of the Combined Therapy. Subject to the terms of this Agreement, within [ * ] or [ * ] after the full execution of this Agreement, or as soon as practicable subsequent to the full execution date, as agreed to by the Parties and prior to dosing the first study patient in a Combined Therapy Trial, Exelixis and BMS (under the guidance of their Pharmacovigilance Departments, or equivalent thereof) shall execute a written pharmacovigilance agreement (“Pharmacovigilance Agreement”) to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations. Such Pharmacovigilance Agreement shall (a) provide that the Conducting Party shall hold and be responsible for the maintenance of the Global Safety Database for the Combined Therapy and safety reporting for the Combined Therapy, and shall lead all pharmacovigilance activities for the Combined Therapy, and (b) include guidelines and procedures acceptable to the Parties for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports, pregnancy reports, and any other information concerning the safety of the Combined Therapy arising from or related to the use of the BMS Compound(s) and Exelixis Compound in the Combined Therapy Trial consistent with Applicable Law. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) Page 14 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in the Pharmacovigilance Agreement, the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole pharmacovigilance responsibility for its Compound(s) subject to all Applicable Law. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as related to the exchange and reporting of safety information associated with use of the products in a Combined Therapy Trial as well as product safety surveillance.. 2.3

Safety Data Exchange. The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of the Combined Therapy. Subject , and to execute a written Pharmacovigilance Memorandum of Understanding within [***] days after the terms Effective Date of this Agreement, within [ * ] Agreement or [ * ] after the full execution of this Agreement, or as soon sooner as practicable subsequent to the full execution date, as and agreed to by the Parties Parties, and prior to the first dosing of the first study patient in a Combined Therapy Trial, Exelixis and BMS (under the guidance of their Pharmacovigilance Departments, or equivalent thereof) shall execute a written pharmacovigilance agreement (“Pharmacovigilance any new clinical trial subject to this Agreement”) to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations. Such Pharmacovigilance Agreement Memorandum of Understanding shall (a) provide that the Conducting Party Recipient shall hold and be responsible for the maintenance of the Global Safety Database for the Combined Therapy Recipient FDC and that BMS shall hold and be responsible for the maintenance of the Global Safety Database for the BMS Compound, (b) provide that the Recipient shall be responsible for the safety reporting for the Combined Therapy, Therapy and shall lead all pharmacovigilance activities for the Combined Therapy, Therapy and (bc) include mutually acceptable guidelines and procedures acceptable to the Parties for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event adverse event reports, pregnancy reports, and any other information concerning the safety of the Combined Therapy arising from or related Therapy. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to the use of the BMS Compound(s) fulfill, local and Exelixis Compound in the Combined Therapy Trial consistent with Applicable Lawinternational regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization Harmonisation (ICH) [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirementsrequirements or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. Until such guidelines In the event of a conflict between the terms this Agreement and procedures are set forth in the terms of Pharmacovigilance Memorandum of Understanding, the Pharmacovigilance Agreement, Memorandum of Understanding shall supersede to the Party responsible for extent related to pharmacovigilance prior to execution matters associated with the Combined Therapy Study and the terms of this Agreement shall have sole pharmacovigilance responsibility for its Compound(s) subject control with respect to all Applicable Lawany other matters. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as related to the exchange and reporting of safety information associated with use of the products in a Combined Therapy Trial as well as product safety surveillance.

Safety Data Exchange. The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of the Combined Therapy. Subject , and to the terms of this Agreement, within [ * ] or [ * ] after the full execution of this Agreement, or as soon as practicable subsequent to the full execution date, as agreed to by the Parties and prior to dosing the first study patient in a Combined Therapy Trial, Exelixis and BMS (under the guidance of their Pharmacovigilance Departments, or equivalent thereof) shall execute a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) within *** after the Effective Date, and prior to ensure the exchange dosing of relevant safety data within appropriate timeframes and the first patient in appropriate format to enable the Parties to fulfill local and international regulatory reporting obligationsfirst Combined Therapy Trial under the Development Plan. Such Pharmacovigilance Agreement shall (a) provide that the Conducting Party Five Prime or its designee shall hold and be responsible for the maintenance of the Global Safety Database for the Combined Therapy and safety reporting for the Combined Therapy, and shall lead all pharmacovigilance activities for the Combined Therapy, and (b) include mutually acceptable guidelines and procedures acceptable to the Parties for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event adverse event reports, pregnancy reports, and any other information concerning the safety of the Combined Therapy arising from or related Therapy. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to the use of the BMS Compound(s) fulfill, local and Exelixis Compound in the Combined Therapy Trial consistent with Applicable Lawinternational regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirementsrequirements or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. Until such guidelines and procedures are set forth in the Pharmacovigilance Agreement, the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole pharmacovigilance responsibility for its Compound(s) subject to all Applicable Law. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as to the extent related solely to the exchange and reporting of safety information associated with use of the products in a Combined Therapy Trial the performance of the Development Plan as well as product safety surveillance., and the provisions of this Agreement shall control with respect to any other such conflict. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXECUTION VERSION