Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall be solely responsible for maintaining the global safety database for Products. […***…]. As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.

Adverse Event Reporting. Pharmacovigilance AgreementUnless otherwise agreed by the Parties, the rights and obligations of the Parties with respect to safety and related reporting activities with respect to Product and the related Subject Constructs will be set forth in a safety agreement to be entered into between the Parties (or their respective Affiliates) no later than the [***] of the Product Schedule Date (or such later date as the Parties may agree). AMAG shall Such agreement will set forth terms and conditions with respect to such activities that are reasonable and customary in the industry for agreements of that nature, and will be solely based on AstraZeneca’s standard form of safety agreement. Pursuant to the safety agreement, AstraZeneca will be responsible for adverse event reporting relating to Product and the related Subject Constructs to applicable Regulatory Authorities in the Territory, and will be responsible for maintaining the global safety database for Productswith respect to Product and the related Subject Constructs. Moderna will assist AstraZeneca by reporting and providing to AstraZeneca all information relating to adverse events to the extent that Moderna has any such data. Such data and other information will be provided in such a manner, time and format, and to such person(s) or department(s), as may be designated by AstraZeneca from time to time, so as to enable AstraZeneca to comply with applicable Law. Moderna and AstraZeneca will reasonably cooperate to ensure that Moderna’s adverse event reporting processes will efficiently communicate such adverse event information in such manner, time and format. […***…]. As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE INDICATES MATERIAL THAT HAS BEEN OMITTED AND REPLACED WITH “[…***…]”FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. A COMPLETE VERSION OF THIS EXHIBIT ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 406 PROMULGATED UNDER THE SECURITIES ACT OF 19341933, AS AMENDED.AMENDED A&R OPTION AGREEMENT

Adverse Event Reporting. Pharmacovigilance AgreementUnless otherwise agreed by the Parties, the rights and obligations of the Parties with respect to safety and related reporting activities with respect to Product and the related Subject Constructs will be set forth in a safety agreement to be entered into between the Parties (or their respective Affiliates) no later than the [***] of the Product Schedule Date (or such later date as the Parties may agree). AMAG shall Such agreement will set forth terms and conditions with respect to such activities that are reasonable and customary in the industry for agreements of that nature, and will be solely based on AstraZeneca’s standard form of safety agreement. Pursuant to the safety agreement, AstraZeneca will be responsible for adverse event reporting relating to Product and the related Subject Constructs to applicable Regulatory Authorities in the Territory, and will be responsible for maintaining the global safety database for Products. […***…]. As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilitiesProduct and the related Subject Constructs. Moderna will assist AstraZeneca by reporting and providing to AstraZeneca all information relating to adverse events to the extent that Moderna has any such data. Such data and other information will be provided in such a manner, time and format, and each Party shall to such person(s) or department(s), as may be solely responsible for costs relating designated by AstraZeneca from time to its respective pharmacovigilance responsibilitiestime, unless agreed otherwise by the Parties in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that so as to enable AstraZeneca to comply with ICH guidelinesapplicable Law. Moderna and AstraZeneca will reasonably cooperate to ensure that Moderna’s adverse event reporting processes will efficiently communicate such adverse event information in such manner, including: (i) providing detailed procedures regarding the maintenance of core safety information time and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Dataformat. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.A&R OPTION AGREEMENT

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall GSK will be solely responsible for maintaining all reporting of adverse events with respect to each Collaboration Product to the global safety database Regulatory Authorities in the Territory and POZEN will be responsible for Products. all reporting of adverse events with respect to any Products developed by POZEN in the Territory for sale outside the Territory in accordance with the terms of this Agreement or other products developed or commercialized by POZEN outside the scope of this Agreement; provided, however, that until the NDA for the Lead Product is transferred to GSK, POZEN will be responsible for all reporting of adverse events with respect CONFIDENTIAL TREATMENT HAS BEEN GRANTED FOR THE REDACTED PORTIONS OF THE AGREEMENT THAT ARE MARKED WITH ASTERISKS AND BRACKETS ([…***…]). As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiencesA COMPLETE COPY OF THIS AGREEMENT, Product qualityINCLUDING THE REDACTED PORTIONS, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. to the appropriate Lead Product to the Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) shall be responsible for . To the pharmacovigilance surveillance and timely reporting of all relevant extent either Party receives any information regarding serious adverse drug reactions/experiencesevents related to the use of a Product, Product qualitywhether such use is within or outside of the Territory, Product complaints and such Party will promptly provide the other Party with such information in accordance with the terms of a Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device Exchange Agreement mutually acceptable to the appropriate Regulatory Authorities Parties to be entered into within 60 days of the Effective Date. To the extent POZEN is required to report adverse events encountered with a Product in connection with POZEN’s activities inside or outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect POZEN will be entitled to their respective pharmacovigilance responsibilitiesreport such adverse events, but prior to doing so, will give GSK as much advance warning of such report as is reasonably possible, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by POZEN will report such adverse events inside or outside the Parties Territory in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance manner which is consistent with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis adverse events for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDEDTerritory.

Adverse Event Reporting. Pharmacovigilance AgreementUnless otherwise agreed by the Parties, the rights and obligations of the Parties with respect to safety and related reporting activities with respect to Product and the related Subject Constructs will be set forth in a safety agreement to be entered into between the Parties (or their respective Affiliates) no later than the [***] of the Product Schedule Date (or such later date as the Parties may agree). AMAG shall Such agreement will set forth terms and conditions with respect to such activities that are reasonable and customary in the industry for agreements of that nature, and will be solely based on AstraZeneca’s standard form of safety agreement. Pursuant to the safety agreement, AstraZeneca will be responsible for adverse event reporting relating to Product and the related Subject Constructs to applicable Regulatory Authorities in the Territory, and will be responsible for maintaining the global safety database for Products. […***…]. As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilitiesProduct and the related Subject Constructs. Moderna will assist AstraZeneca by reporting and providing to AstraZeneca all information relating to adverse events to the extent that Moderna has any such data. Such data and other information will be provided in such a manner, time and format, and each Party shall to such person(s) or department(s), as may be solely responsible for costs relating designated by AstraZeneca from time to its respective pharmacovigilance responsibilitiestime, unless agreed otherwise by the Parties in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that so as to enable AstraZeneca to comply with ICH guidelinesapplicable Law. Moderna and AstraZeneca will reasonably cooperate to ensure that Moderna’s adverse event reporting processes will efficiently communicate such adverse event information in such manner, including: (i) providing detailed procedures regarding the maintenance of core safety information time and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDEDformat.

Adverse Event Reporting. Pharmacovigilance AgreementThe Parties agree to comply with any and all Applicable Laws that are applicable as of the Effective Date and thereafter during the Term in connection with a Compound/Product’s safety data collection and reporting. AMAG The sponsor of a Clinical Trial shall be solely accountable for reporting all information required to be submitted to health authorities, ethic committees, institutional review boards and investigators as required by Applicable Laws and regulations concerning its sponsored Clinical Trial(s). Company shall be the marketing authorization holder and shall be solely responsible for maintaining reporting all information required to be submitted to health authorities in order to maintain any health authority approval granted for the Product(s) in the Territory. If required by Applicable Laws, the Parties (or their respective Affiliates) shall negotiate in good faith and enter into a safety data exchange agreement (such written agreement, the “Safety Data Exchange Agreement”) for exchanging adverse event and other safety information relating to the Compounds. Unless otherwise agreed and defined in the Safety Data Exchange Agreement, until the transfer of IND No. [*] and global safety database for Productsownership is completed, if either Party has or receives any new safety information which may be related to the use of the Compounds or Products and which may have an impact to the reporting obligations of the other Party under Applicable Laws, such Party shall provide the other Party with all such information in English within such reasonable timelines which enable such other Party to comply with all Applicable Laws and relevant regulations and requirements. […***…]Subject to the Existing License, Company shall have the sole decision and right to determine whether and how to implement a recall or other market withdrawal of any Product Developed or Commercialized by Company. As The information exchanged between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating Parties pursuant to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(sthis Section 3.7(b) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiencestransmitted by e-mail, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product facsimile or Product Delivery Device overnight courier to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other with respect following address: Transmission to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. Within […***…] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Company:

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall be solely responsible During the Merck Participation Term for maintaining the global safety database for Products. a given Program, prior to […***…]. As between the Parties: (a) AMAG ] shall be responsible for individual and aggregate safety reporting for any Clinical Studies involving the pharmacovigilance surveillance and timely reporting applicable Collaboration Product for such Program (as applicable), [***] shall provide [***] an electronic copy of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) [***]. Upon receipt of completion of [***] shall be responsible assume responsibility for the pharmacovigilance surveillance individual and timely aggregate safety reporting (as applicable) [***]. Until [***], each Party agrees to notify the other Party of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other information of which such Party becomes aware concerning any Adverse Events with respect to their respective pharmacovigilance responsibilities, and each Party such Collaboration Product for such Program. Such notice shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by provided in English in the Parties in writing. Within form of a processed CIOMS I within […***…] after the Effective Date, the Parties shall enter into days of such Party receiving such information where such potential Adverse Events is a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information SAE and the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance associated with the reporting requirements clinical uses, Clinical Studies, investigations, tests or marketing of all applicable Regulatory Authorities on a worldwide basis such Collaboration Product for the reporting such Program. Adverse Event reports of Safety Data in accordance with standards stipulated in the ICH guidelines, unexpected and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “fatal […***…]”] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. A COMPLETE VERSION OF THIS EXHIBIT ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 406 PROMULGATED UNDER THE SECURITIES ACT OF 19341933, AS AMENDEDAMENDED or life-threatening events which are possibly, probably, definitely related or of unknown relationship to the use of a given Collaboration Product for such Program must be forwarded to the other Party within [***] after receipt of such information. It is understood and agreed that these Adverse Events reporting requirement provisions are based on the respective policies and procedures of the Parties and applicable regulatory reporting requirements. In the event of changes to applicable regulatory requirements for Adverse Events reporting, the Parties agree to comply with any such required revised notification requirements. At this same time, Moderna and Merck shall enter into discussions regarding one or more pharmacovigilance agreements (or updates to the current pharmacovigilance agreement) for the Collaboration Product for such Program, as applicable (the “Pharmacovigilance Agreement”). In all cases, [***]. For the avoidance of doubt, [***].

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall be solely responsible for maintaining Takeda (or its designee), as the global safety database for Products. […***…]. As between holder of the Parties: Regulatory Approvals (aincluding the MAA) AMAG in the Takeda Territory, shall be responsible for the pharmacovigilance surveillance collection, review, assessment, tracking and timely reporting filing of all relevant information related to adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to events 94065460_6 associated with the appropriate Regulatory Authorities Vaccine in the Territory; and Takeda Territory (b) Palatin whether or its licensee(s) shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate not Regulatory Authorities outside the TerritoryApproval has been achieved), in each case in accordance with applicable Applicable Laws and this Agreement (and Takeda shall ensure that, in the Development and Commercialization of the Vaccine, it or its designee will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws). Novavax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Vaccine in the countries in the Novavax Territory (and Novavax shall ensure that, in the Development and Commercialization of the Vaccine in the Novavax Territory, it or its designee will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws). The Parties shall will cooperate with each other with respect regard to their respective pharmacovigilance responsibilitiesthe monitoring, exchange, and each Party shall be solely responsible for costs relating to its respective reporting of safety information involving the Vaccine in accordance with Applicable Laws on pharmacovigilance responsibilities, unless agreed otherwise by the and clinical safety. The Parties have negotiated in writing. Within […***…] after the Effective Date, the Parties shall enter good faith and entered into a pharmacovigilance agreement on terms (“PVA”) prior to the Effective Date as is necessary to ensure that comply with ICH guidelinesall regulatory requirements are met in order to formalize their respective safety data exchange and pharmacovigilance responsibilities for the Vaccine (for clinical or commercial use), including: (i) providing detailed procedures regarding the maintenance of core including serious adverse events and emerging safety information and the exchange of Safety Data relating to all Compoundsissues, Products, Pharmaceutical Products and Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited comply with all of its legal and periodic regulatory reporting requirements; obligations in respect of the Vaccine. In the event of any conflict between any of the provisions of the PVA and (ii) ensuring compliance with this Agreement in matters of business, financial or legal nature, the reporting requirements terms of all applicable Regulatory Authorities on a worldwide basis for this Agreement shall prevail. For matters of pharmacovigilance, the reporting terms of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDEDPVA shall prevail.