Common use of Pharmacovigilance Agreement Clause in Contracts

Pharmacovigilance Agreement. Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall 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 any Licensed Compound(s). 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 Harmonization (ICH) 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 a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. 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 information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Pharmacovigilance Agreement. Within [Adaptimmune will be solely responsible for compliance with all Applicable Laws pertaining to safety reporting for the Study and related activities. The Parties will execute a pharmacovigilance agreement (“Pharmacovigilance Agreement”) prior to the initiation of clinical activities under the Study, but in any event within ***] * days after the Effective Date, BMS to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews. In the event of any inconsistency between the terms of this Agreement and the Company (under Pharmacovigilance Agreement, the guidance terms of their respective Pharmacovigilance Departments, or equivalent thereof) shall define this *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection filed separately with the use Commission. Agreement shall control. The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receiptcollection, investigation, recordation, communicationreporting, and exchange (as between the Parties) of information concerning any adverse event reportsexperiences, pregnancy reports, and any other safety information concerning arising from or related to the safety use of any Licensed Compound(s)the Merck Compound and Adaptimmune Compound in the Study, consistent with Applicable Law. 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 authoritiesGovernment Authorities. FurthermoreIn addition, such agreed procedures to the extent that Merck is required by Applicable Law to report payments made by Adaptimmune and its Subcontractors to physicians or teaching hospitals, it shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirementsprovide on a timely basis, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred consultation with Merck, all information necessary to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. 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 information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosedcomply with Applicable Law.

Pharmacovigilance Agreement. Within [***Subject to the terms of this Agreement, and within [ * ] after the Effective Date[ * ] with respect to a Collaboration Program, BMS and the Company Exelixis (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with a written Agreement (hereafter referred to as the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company“Pharmacovigilance Agreement”). These responsibilities shall 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 any Licensed Compound(s)Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international national regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization Harmonisation (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by BMS. Each Party hereby agrees to comply with its respective obligations under such guidelines and procedures are set forth in a written agreement between Pharmacovigilance Agreement (as the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties may agree to implement the necessary procedures modify it from time to time) and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilledcause its Affiliates and Sublicensees to comply with such obligations. [ * ] = Certain confidential information contained in this document, marked as [***] by brackets, has been excluded from this exhibit because it is both (i) not material omitted and (ii) would be competitively harmful if publicly disclosedfiled separately with the Securities and Exchange Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as amended.

Pharmacovigilance Agreement. Within Subject to the terms of this Agreement, and within [***] after the Original Effective Date, BMS and the Company EXEL (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define re-define, re-state and finalize the responsibilities the Parties BMS and EXEL shall employ to protect patients and promote their well-being in connection with for XL184, XL281 and any future Collaboration Compounds under separate pharmacovigilance agreements, based on the use Pharmacovigilance Agreement dated as of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to CompanyAugust 13, 2008 (each, a “Pharmacovigilance Agreement”). These responsibilities shall 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 any Licensed Compound(s)such Product. Such guidelines and procedures shall be in accordance with, and enable the Parties BMS and EXEL and their Affiliates to fulfill, local and international national regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization Harmonisation (ICH) 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 The Pharmacovigilance Agreements will provide for a worldwide safety database to be maintained by BMS or EXEL (as applicable), and procedures are set forth the Pharmacovigilance Agreement for XL281 shall contain a safety reporting procedure (as described [*] = Certain confidential information contained in a written agreement 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. in Appendix IV of the Safety Data Exchange Agreement that is between the Parties and that is dated July 20, 2009). Each of BMS and EXEL hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties may agree to implement the necessary procedures modify it from time to time) and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material cause its Affiliates and (ii) would be competitively harmful if publicly disclosedSublicensees to comply with such obligations).

Pharmacovigilance Agreement. Within [***] after of the License Effective Date, BMS and but in any event prior to commencement of any clinical trials with respect to the Company (under Licensed Product in the guidance of their respective Pharmacovigilance DepartmentsTerritory, or equivalent thereof) shall define the Parties will in good faith negotiate and finalize a safety data exchange agreement (the responsibilities “Pharmacovigilance Agreement”), the Parties terms of which shall employ to protect patients set forth the guidelines, obligations, procedures and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures timelines for the receipt, investigation, recordationrecording, communication, and exchange (as between the Parties) of adverse event Adverse Event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). 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 Harmonization (ICH) 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 a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. 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 information marked as Product or observed in [***] has been excluded from this exhibit because it is both = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (iI) not material IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED] connection with the Licensed Product, and (ii) would be competitively harmful if publicly disclosedother routine pharmacovigilance reporting requirements, in order to enable the other Party to comply with its safety reporting obligations to the applicable Regulatory Authorities and to protect patients and promote their well-being. The Pharmacovigilance Agreement shall include terms governing each Party’s responsibility for preparing Adverse Event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products, for filing such reports and responses with Regulatory Authorities in the Territory, and for reporting any quality complaints, Adverse Events and safety data related to Licensed Products in the Territory for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted Sublicensees or licensees to comply with such obligations.

Pharmacovigilance Agreement. Within Subject to the terms of this Agreement, and within [***] after the Effective Date[*] with respect to a Collaboration Program, BMS and the Company EXEL (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties BMS and EXEL shall employ to protect patients and promote their well-being in connection with a written Agreement (hereafter referred to as the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company“Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the PartiesBMS and EXEL) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s)Product. Such guidelines and procedures shall be in accordance with, and enable the Parties BMS and EXEL and their Affiliates to fulfill, local and international national regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization Harmonisation (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by BMS. Each of BMS and EXEL hereby agrees to comply with its respective obligations under such guidelines Pharmacovigilance Agreement (as BMS and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties EXEL may agree to implement the necessary procedures modify it from time to time) and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material cause its Affiliates and (ii) would be competitively harmful if publicly disclosedSublicensees to comply with such obligations.