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, and to execute a written Pharmacovigilance Memorandum of Understanding within [***] days after the Effective Date of this Agreement or sooner as practicable and agreed to by the Parties, and prior to the first dosing of the first study patient in any new clinical trial subject to this Agreement. Such Pharmacovigilance Memorandum of Understanding shall (a) provide that Recipient shall hold and be responsible for the maintenance of the Global Safety Database for the 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 and shall lead all pharmacovigilance activities for the Combined Therapy and (c) include mutually acceptable guidelines and procedures 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. 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 government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. In the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Memorandum of Understanding, the Pharmacovigilance Memorandum of Understanding shall supersede to the extent related to pharmacovigilance matters associated with the Combined Therapy Study and the terms of this Agreement control with respect to any 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.

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, and to execute a written Pharmacovigilance Memorandum of Understanding within [***[ * ] days or [ * ] after the Effective Date full execution of this Agreement Agreement, or sooner as soon as practicable and subsequent to the full execution date, as agreed to by the Parties, Parties and prior to the first dosing of the first study patient in any new clinical trial subject 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 this Agreementensure 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 Memorandum of Understanding Agreement shall (a) provide that Recipient the Conducting Party shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient FDC Combined Therapy 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 (cb) 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. Such guidelines Therapy arising from or related to the use of the BMS Compound(s) and procedures shall be Exelixis Compound in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authoritiesCombined Therapy Trial consistent with Applicable Law. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation 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 or Applicable Lawrequirements, in which case local reporting requirements or Applicable Law shall prevail. In Until such guidelines and procedures are set forth in the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Memorandum of UnderstandingAgreement, the Pharmacovigilance Memorandum of Understanding shall supersede Party responsible for pharmacovigilance prior to the extent related to pharmacovigilance matters associated with the Combined Therapy Study and the terms execution of this Agreement control with respect shall have sole pharmacovigilance responsibility for its Compound(s) subject to any other mattersall 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, and to execute a written pharmacovigilance agreement (the “Pharmacovigilance Memorandum of Understanding Agreement”) within [***] ninety (90) days after the Effective Date of this Agreement or sooner as practicable and agreed to by the Parties, and prior to the first dosing of the first study patient in any new clinical trial subject to this Agreement. Such Pharmacovigilance Memorandum of Understanding Agreement shall (a) provide that Recipient Compugen shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient FDC Compugen Compound 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 Sponsoring Party for the applicable Combined Therapy Study shall be responsible for the safety reporting for the applicable Combined Therapy and shall lead all pharmacovigilance activities for the applicable Combined Therapy and (c) include mutually acceptable guidelines and procedures 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. 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 government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. In the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Memorandum of UnderstandingAgreement, the Pharmacovigilance Memorandum of Understanding Agreement shall supersede to the extent related to pharmacovigilance matters associated with the Combined Therapy Study and the terms of this Agreement control with respect to any 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. [*] = 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.

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, and to execute a written pharmacovigilance agreement (the “Pharmacovigilance Memorandum of Understanding Agreement”) within [***] days * after the Effective Date of this Agreement or sooner as practicable and agreed to by the PartiesDate, and prior to the first dosing of the first study patient in any new clinical trial subject to this Agreementthe first Combined Therapy Trial under the Development Plan. Such Pharmacovigilance Memorandum of Understanding Agreement shall (a) provide that Recipient Five Prime or its designee shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient FDC Combined Therapy 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 (cb) include mutually acceptable guidelines and procedures 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. 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 government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. In the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Memorandum of Understanding, the Pharmacovigilance Memorandum of Understanding shall supersede to the extent related to pharmacovigilance matters associated with the Combined Therapy Study and the terms of this Agreement control with respect to any 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 to the extent related solely to the exchange and reporting of safety information associated with use of the products in 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.

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, and to execute a written Pharmacovigilance Memorandum of Understanding within [***[ * ] days or [ * ] after the Effective Date full execution of this Agreement Agreement, or sooner as soon as practicable and subsequent to the full execution date, as agreed to by the Parties, Parties and prior to the first dosing of the first study patient in any new clinical trial subject 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 this Agreementensure 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 Memorandum of Understanding Agreement shall (a) provide that Recipient the Conducting Party shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient FDC Combined Therapy 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 (cb) 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. Such guidelines Therapy arising from or related to the use of the BMS Compound(s) and procedures shall be Exelixis Compound in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authoritiesCombined Therapy Trial consistent with Applicable Law. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonisation 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 or Applicable Lawrequirements, in which case local reporting requirements or Applicable Law shall prevail. In Until such guidelines and procedures are set forth in the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Memorandum of UnderstandingAgreement, the Pharmacovigilance Memorandum of Understanding shall supersede Party responsible for pharmacovigilance prior to the extent related to pharmacovigilance matters associated with the Combined Therapy Study and the terms execution of this Agreement control with respect shall have sole pharmacovigilance responsibility for its Compound(s) subject to any other mattersall 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.