Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. (a) GW shall be responsible for maintaining the global safety database for each Product and for monitoring the overall safety of the Product, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. (a) GW shall be responsible The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in accordance with the applicable regulatory Laws on pharmacovigilance and clinical safety, with Eureka being responsible, at its cost, for maintaining the a global safety database for each Product database, and for monitoring the overall safety of the ProductLicensee being responsible, including signal detection. (b) Novartis shall be responsible at its cost, for pharmacovigilance activities with respect to Products reporting in the Licensee Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) . Within six (6) months 120 days following the Effective Date (or as such longer period as may be agreed between extended by mutual written agreement of the Parties, but within such time to ensure that all regulatory requirements are met), the Parties shall agree upon will negotiate in good faith and implement enter into a procedure for pharmacovigilance agreement related to the mutual exchangeLicensed Products, receipt, record, communication and investigation of adverse event reports and safety or other information associated with which will define the Products covered by this Section 6.5. Details pharmacovigilance responsibilities of the operating procedure respecting such adverse event reports Parties and include safety data exchange procedures governing the exchange of information exchange shall be affecting the subject of a mutually-agreed written pharmacovigilance agreement Licensed Products (e.g., Adverse Events, Serious Adverse Events, emerging safety issues) to enable each Party to comply with all Laws related to the Licensed Products (the “Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to Without limiting the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with foregoing or anything under the Pharmacovigilance Agreement, a directed audit may be performed unless otherwise mutually agreed by either Partythe Parties, or an independent Third Partyduring the Term, upon thirty each Party shall, and shall cause its Affiliates, licensees and sublicensees to, (30a) days written notice disclose to the auditeeother Party all information relating to Serious Adverse Events from any clinical use of any Licensed Product in its respective Territory for storage into its global safety database, without further need for agreement between the Parties. (fb) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall on at least a monthly basis, provide the other Party with written notice an update of all safety data (at including all Serious Adverse Events) with respect to the time of the notificationLicensed Product in its respective Territory, (c) of any inspection addressing Product-specific pharmacovigilance and allow a representative from notify the other Party to attend within five Business Days of any identified safety signals, (d) notify the other Party within two Business Days of any emerging safety issues, and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting (e) upon the other Party’s request, provide to such other Party any pharmacovigilance activities or clinical safety data within fourteen (14) five Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impactedsuch request.

Pharmacovigilance. (a) GW shall be responsible for maintaining Until the global safety database for each Product and for monitoring the overall safety end of the ProductService Period set forth in item 8 in the Work Order (such period, as the same may be modified in a Change Order or terminated by the Company pursuant to Section 7.2.1, the “PV Service Period”), Seller shall bear responsibility for pharmacovigilance relating to the Compound and Products, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting timely reporting of all adverse drug reactions/experiences and processing aggregate safety data and reporting relating to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following Compound. As part of the Effective Date (or such longer period as may be agreed between Services, Seller shall communicate with the Parties)Company regarding Product pharmacovigilance matters and, in furtherance thereof, the Parties shall agree upon enter into a separate agreement setting forth the pharmacovigilance responsibilities and implement a procedure procedures for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall to be carried out by the subject of a mutually-agreed written pharmacovigilance agreement Parties (the “Pharmacovigilance Agreement”) between ). The Pharmacovigilance Agreement shall contain guidelines and procedures for the Parties which receipt, investigation, recording, communication, and exchange of reports of adverse drug reactions/experiences, safety data and other information concerning the safety of Product or the Compound (“Safety Information”), and shall be entered into within in all events include such six (6) month period (or such longer period terms as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals are necessary to ensure that the elements set forth Parties comply with Applicable Laws and meet the reporting requirements of any applicable Governmental Entity. Without limiting the foregoing, prior to execution of the Pharmacovigilance Agreement, Seller shall instruct Quintiles, Inc. to copy the Company’s Transition Manager on all communications transmitting Safety Information to Seller, and in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree event Seller receives any Safety Information that meets the criteria for a Serious, Suspected Adverse Drug Reaction (as defined in good faith on how ICH E2A) in a communication to which the Company is not copied, Seller shall send the source documents including such audits will be conducted Safety Information that were transmitted by Quintiles, Inc. to the Company, or other mutually agreed format, via email or fax as soon as possible, but, in any event, not later than One (including with respect 1) Business Day after Seller receives such Safety Information, and, in the event Seller receives any information concerning any investigation, inquiry or other action by any Governmental Entity concerning the safety of the Compound or Product, Seller shall send such information to audit planthe Company via email or fax as soon as possible, duration of auditbut in any event, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently later than once every two (2) yearsdays after Seller receives notice of such investigation, with a minimum of 90 days noticeinquiry or other action. All As soon as reasonably practicable after the PV Service Period or such audits earlier time as may be requested in writing by the Company, Seller shall take all actions as reasonably may be reasonable in scope, limited required to effectuate the transfer to the ProductCompany of all Safety Information, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions including the portion of Seller’s global safety database that pertains to the other PartyCompound and the Products. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. The Parties undertake to co-operate in the collection, review, assessment, tracking and filing of information related to Adverse Events and Adverse Drug Reactions associated with the Product and, in the case of Nycomed, other products incorporating the Compound for use in fields other than the Field, in accordance with US 21 CFR 312.32, 314.80 and the Pharmacovigilance Standard Operating Procedure (aSOP) GW ("Ciclesonide Pre- and Post Marketing Surveillance Standard Operating Procedures (SOP)") and a Pharmacovigilance Exchange Agreement (PVEA) the definitive terms of which will be agreed by the parties within ninety (90) days of the Effective Date (and in any event, prior to the sale of any Product) and will be attached as Schedule 12.4 to this Agreement. Without limitation, the Parties agree to promptly communicate to each other all information that comes to their attention pertaining to Adverse Events and Adverse Drug Reactions or side effects developing in persons who have been administered the Product. Information regarding serious (as defined in Schedule 12.4) Adverse Events and serious Adverse Drug Reactions (whether expected or unexpected) of which a Party becomes aware shall be transmitted to the impacted Party without undue delay within the time periods specified in Schedule 12.4. Nycomed shall be responsible for maintaining the a global safety database for each the Product and consistent with industry practices, to which Sepracor shall have access at all times during the Term, except during such limited times that the database is offline for monitoring the overall safety of the Product, including signal detection. (b) Novartis routine maintenance. Sepracor shall be responsible for pharmacovigilance activities AE and ADR processing, expedited, and periodic reporting of AEs and ADRs to the Regulatory Authorities in accordance with respect to Products all applicable AE regulatory reporting requirements in the Territory, including collecting and processing safety data Nycomed shall be responsible for such activities in the ROW, both at their cost and reporting to expense. Nycomed shall provide summary reports of adverse events at regular intervals consistent with the Regulatory Authorities as intervals required under applicable Laws. international reporting requirements for period reporting (c) Within six (6) months following U.S. Periodic Reporting requirements and Periodic Safety Reporting requirements in the Effective Date (or such longer period as may be agreed between the PartiesEU), the Parties shall agree and at other times, upon and implement a procedure for the mutual exchangereasonable written request by Sepracor, receipt, record, communication and investigation of adverse event such summary reports and safety or other information associated to be set up in accordance with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth Periodic Safety Reporting requirements in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other PartyEU. (e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

Pharmacovigilance. 7.6.1 On a Collaboration Target-by-Collaboration Target basis, prior to the Initiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, the Parties will enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products Directed Against such Collaboration Target (a) GW shall the “Pharmacovigilance Agreement”). Such procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party will be responsible for maintaining reporting quality complaints, adverse events and safety data related to the Licensed Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, in each case at its own cost. The initial global safety database will be established by Kymera using its Approved Third Party Contractors, and Kymera will, at Xxxxxx’s sole cost and expense, transfer such global safety database to Sanofi upon Sanofi’s written request reasonably in advance of the desired transfer date, which transfer date will be no later than [***] and in the form requested by Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Products prior to Sanofi’s assumption and implementation of the global safety database for each Product and for monitoring the overall safety of the Product, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated accordance with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) . Each Party agrees that the other may audit to comply with its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in respective obligations under the Pharmacovigilance Agreement are being metand to [***] comply with such obligations. The Parties Among other things, the Pharmacovigilance Agreement will discuss and agree in good faith on how such audits will be conducted (including with respect provide the right for each Party to audit plan, duration cross-reference all relevant safety data of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. 7.6.2 Without limiting the foregoing, (ea) Notwithstanding paragraph if a Material Safety Event occurs during the Sanofi Participation Term, and [***], Sanofi will provide written notice thereof to Kymera (da “Sanofi Material Safety Event Notice”) aboveand (b) if a Party, in the case accordance with such Party’s internal operating procedures consistently applied across its own pharmaceutical products, determines that a Material Safety Event has occurred with respect to a Clinical Trial conducted by or on behalf of a serious suspected breach of compliance with the Pharmacovigilance Kymera under this Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days such Party will provide written notice thereof to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in (a “Kymera Material Safety Event Notice”). Any such inspections. The inspected notice issued by a Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party under this Section 7.6.2 will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impactedinclude [***].

Pharmacovigilance. (a) GW Licensee acknowledges that Licensor is bound by the pharmacovigilance and safety information exchange requirements of the MedImmune License and the SFJ Agreement and the terms of the MedImmune Pharmacovigilance Agreement and the SFJ Pharmacovigilance Agreement (copies of which are attached hereto as Exhibit 4.3.6(a)) relating both to the Licensed Product and that, in order to comply with its obligations to MedImmune and SFJ, Licensee must provide adverse event and other safety information relating to the Licensed Product to Licensor in a form and within the applicable time periods necessary for Licensor to comply with the MedImmune License and the SFJ Agreement and the terms of the MedImmune Pharmacovigilance Agreement and the SFJ Pharmacovigilance Agreement. (b) The safety reporting units from each of the Parties shall meet and shall within one hundred eighty (180) days of the Effective Date, agree upon a written agreement for exchanging adverse event and other safety information relating to the Licensed Product in the Field in the Territory (the “Licensee Pharmacovigilance Agreement”). The Licensee Pharmacovigilance Agreement will (i) provide that Licensee shall not take or fail to take any action relating to the exchange of adverse event and other safety information in breach of the Licensee Pharmacovigilance Agreement that would cause Licensor to be responsible in breach of the MedImmune License, the SFJ Agreement, the MedImmune Pharmacovigilance Agreement and the SFJ Pharmacovigilance Agreement; and (ii) ensure that each Party complies with Applicable Law and the requirements of Regulatory Authorities. (c) Licensee agrees not to enter into any clinical activity implicating pharmacovigilance obligations for maintaining the Licensed Product prior to execution of the Licensee Pharmacovigilance Agreement. (d) Licensor shall establish and maintain the global safety database for each the Licensed Product. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Licensed Product in its territory to such database and for monitoring to the overall applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Licensed Product, including signal detection. (b) Novartis in each case at its own cost and to the extent required by Applicable Law; for the sake of clarity, Licensor shall be responsible have the primary responsibility for pharmacovigilance activities with respect reporting quality complaints, adverse events and safety data related to Products in the Licensed Product outside the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) Each Party agrees that to comply with its respective obligations under the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Licensee Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Productcause its Affiliates, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Partycomply with such obligations. (e) Notwithstanding paragraph (d) aboveLicensee acknowledges that the safety of the Licensed Product may affect the safety and use of the AstraZeneca Product and Licensee agrees to provide Licensor, in a timely manner with all safety information relating to the case of a serious suspected breach of compliance Licensed Product in the Territory that is necessary for Licensor to comply with its obligations under the MedImmune Pharmacovigilance Agreement. Without limiting the foregoing, a directed audit may be performed Licensor shall have the right to allow MedImmune to access and copy safety reporting information provided by either Party, or an independent Third Party, upon thirty (30) days written notice Licensee regarding the Licensed Product in the Territory solely as required for Licensor to comply with its obligations under the auditee, without further need for agreement between the PartiesMedImmune License. (f) The With respect to any Licensed Product, unless otherwise agreed by the Parties in writing, Licensee shall allow foreign notify in writing Licensor or such Affiliate as Licensor may designate of any adverse events and local Regulatory Authorities other safety-relevant information and complaints associated with such Licensed Product in the Field in the Territory (each, a “Spontaneous Adverse Event”) of which Licensee becomes aware, outside the conduct of clinical studies within one (1) Business Day after Licensee first learns of such Spontaneous Adverse Event. (g) Licensee shall notify Licensor according to inspect their pharmacovigilance operations as it is necessary the timelines under the Licensee Pharmacovigilance Agreement, regardless of seriousness, causality, and whether or not the Licensed Product was used in accordance with the authorized Summary of Product Characteristics (SPC) or any other conditions laid down for Novartis to obtain and maintain Regulatory Approvals marketing of the Licensed Product in accordance with applicable legal requirements including: (i) reports of suspected transmission of an infectious agent for the Products Licensed Product and (ii) reports of lack of effect, pregnancy, lactation/paternal exposure, medication error, overdose, off-label use, drug interaction, abuse or misuse of the Licensed Product. (h) Additionally, unless otherwise agreed, Licensee shall notify in countries writing Licensor or such Affiliate as Licensor may designate, of any serious adverse events and other safety-relevant information and complaints associated with such Licensed Product in the Field in the Territory (each, a “Serious Adverse Event”) of which Licensee becomes aware under the conduct of clinical studies within timelines set forth in Schedule 4.3.6(h), after Licensee first learns of such Serious Adverse Event, as a processed report (e.g., CIOMS or E2B file). (i) Licensee shall notify in writing Licensor of any other safety-relevant information and complaints associated with such Licensed Product in the Territory that is not a Serious Adverse Event (each, an “Other Adverse Event”) of which Licensee becomes aware in the course of conducting clinical trials promptly after Licensee first learns of such Other Adverse Event. (j) Licensee shall cooperate with Licensor and MedImmune to investigate and follow-up on any such Serious Adverse Events or Other Adverse Events associated with such Licensed Product. For clarity, Licensor or its Affiliate shall have final decision-making authority as to whether and how to report safety information pertaining to any Licensed Product outside the Territory, and Licensee shall have final decision-making authority as to whether and how to report safety information pertaining to any Licensed Product in the Territory. Each . (k) Paragraphs (f), (g), (h), (i) and (j) of this Section 4.3.6, shall also apply to Licensor, mutatis mutandis. (l) Licensee shall provide reasonable assistance to and cooperate with MedImmune concerning any adverse events and other safety-relevant information and complaints associated with the AstraZeneca Product, the extent that the safety information is available to Licensee, if requested to do so in writing by Licensor. (m) Without limitation to any of the foregoing, Licensee shall ensure that all applicable patient authorizations and consents required under Applicable Law, including the Health Insurance Portability and Accountability Act of 1996 and the EU Data Protection Directive 95/46/EC, in connection with safety information pertaining to the Licensed Compounds and Licensed Product from any sources, permit such sharing of safety information with Licensor and MedImmune or its Affiliate, including patient information required to contact the reporter where the source is outside the conduct of a clinical study. (n) Unless already provided or otherwise communicated to the other Party pursuant to this Section 4.3.6 and/or the Licensee Pharmacovigilance Agreement, each Party shall provide the other with written notice (Party at the time meetings of the notification) JSC (or in advance of any inspection addressing Product-specific pharmacovigilance and allow such meetings as part of the information that may be distributed to JSC members prior to such meetings or, if no such meeting is held in a representative from the other Party Calendar Quarter, directly to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen ) at least once during each Calendar Quarter with summaries of all data known to such Party material to obtaining Regulatory Approval, and material Licensed Product safety data in all indications (14) Business Days of receipt of documented findings cited during a including but not limited to Serious Safety Issues), including such material data relating to efficacy, clinical sites, patient enrolment and drop-out rates, CMC and other material manufacturing data, and material communications with Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impactedAuthorities.

Pharmacovigilance. 7.6.1 On a Collaboration Target-by-Collaboration Target basis, prior to the Initiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, the Parties will enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products Directed Against such Collaboration Target (a) GW shall the “Pharmacovigilance Agreement”). Such procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party will be responsible for maintaining reporting quality complaints, adverse events and safety data related to the Licensed Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, in each case at its own cost. The initial global safety database will be established by Kymera using its Approved Third Party Contractors, and Kymera will, at Xxxxxx’s sole cost and expense, transfer such global safety database to Sanofi upon Sanofi’s written request reasonably in advance of the desired transfer date, which transfer date will be no later than [***] and in the form requested by Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Products prior to Sanofi’s assumption and implementation of the global safety database for each Product and for monitoring the overall safety of the Product, including signal detection. (b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws. (c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and safety or other information associated accordance with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties). (d) . Each Party agrees that the other may audit to comply with its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in respective obligations under the Pharmacovigilance Agreement are being metand to [***] comply with such obligations. The Parties Among other things, the Pharmacovigilance Agreement will discuss and agree in good faith on how such audits will be conducted (including with respect provide the right for each Party to audit plan, duration cross-reference all relevant safety data of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party. 7.6.2 Without limiting the foregoing, (ea) Notwithstanding paragraph if a Material Safety Event occurs during the Sanofi Participation Term, and [***], Sanofi will provide written notice thereof to Kymera (da “Sanofi Material Safety Event Notice”) aboveand (b) if a Party, in the case of a serious suspected breach of compliance accordance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties. (f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during internal operating procedures consistently applied across its own pharmaceutical products, determines that a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide Material Safety Event has occurred with respect to a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.Clinical Trial