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 Agreement. AMAG shall be solely responsible for maintaining the global safety database for Products. […***…]. As between the Parties: (a) AMAG Parties shall be responsible commence negotiations on the Pharmacovigilance Agreement promptly following the Effective Date, and no later than six (6) months prior to the first sale of the Product in the Territory, Partner and PolyPid shall execute the Pharmacovigilance Agreement, setting forth the worldwide safety and pharmacovigilance procedures for the Parties with respect to Products, such as safety data sharing and exchange, Adverse Events reporting (including pregnancy reports and special situation) and prescription events monitoring. The Pharmacovigilance Agreement sets forth and describes the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, or sublicensees to comply with its legal obligations. The Parties shall promptly update the Pharmacovigilance Agreement if required by changes in Applicable Laws. Each Party shall comply with its respective obligations under the Pharmacovigilance Agreement and shall cause its Affiliates and sublicensees to comply with such obligations. If there is any conflict or inconsistency between this Agreement and the Pharmacovigilance Agreement, then the Pharmacovigilance Agreement will control to the extent the conflict or inconsistency relates to a matter involving pharmacovigilance, including the safety data exchange of the Product. The Pharmacovigilance Agreement is hereby incorporated by reference. (b) In accordance with the terms of the Pharmacovigilance Agreement, Partner shall maintain a pharmacovigilance surveillance system for Products in the Territory, at its sole cost and timely reporting of all relevant adverse drug reactions/experiencesexpense, Product qualityand shall promptly report to PolyPid, Product complaints in writing, any quality complaints, Adverse Events, safety case scenarios and Safety Data relating safety events related to Products and shall, for special case scenarios, obtain PolyPid’s prior written approval with respect to any Compound, Product, Pharmaceutical Product or Product Delivery Device information and/or reports to be provided to the appropriate applicable Regulatory Authorities in the Territory; and (b) Palatin or its licensee(s) . Partner shall be responsible provide to PolyPid data from the Partner’s Adverse Event database for the Territory and any other data required supporting the global pharmacovigilance surveillance requirements. PolyPid shall maintain a global Adverse Event database at its sole cost and timely reporting of all relevant adverse drug reactions/experiencesexpense, Product qualityand, Product complaints and Safety Data relating to any Compoundexcept as prohibited by Applicable Law, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, shall provide Partner with information contained in each case such global Adverse Event database in accordance with applicable Laws. The Parties the terms of the Pharmacovigilance Agreement. (c) Each Party shall cooperate comply with each other with respect to their all Applicable Laws governing Adverse Events in its respective pharmacovigilance responsibilitiesterritory, and each shall notify the other Party on a timely basis of any Adverse Events occurring in its respective territory as set forth in the Pharmacovigilance Agreement. Partner is responsible for complying with Applicable Laws governing Adverse Events in the Territory at its sole expense. Each Party shall be solely responsible for costs relating submit copies of reports of Adverse Events 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 other 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 as described 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 AMENDEDPharmacovigilance Agreement.

Adverse Event Reporting. No later than forty-five (45) Days after the submission of the first IND Application in the NextCure Territory (or the Effective Date, if later), NextCure and Zaiming shall develop and agree in a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to the Development and Commercialization of Licensed Products, such as safety data sharing and exchange, adverse events reporting, and prescription events monitoring rights and procedures as are conventional in the industry (the “Pharmacovigilance Agreement”). AMAG Such Pharmacovigilance Agreement shall (i) provide that (x) with respect to Zaiming Product, Zaiming shall hold and be solely responsible for maintaining the maintenance of the global safety database for Products. […***…]. As between the Parties: (a) AMAG Zaiming Product, and that Zaiming or NextCure, as applicable, shall hold and be responsible for the pharmacovigilance surveillance and timely reporting maintenance 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 a safety database for the pharmacovigilance surveillance and timely purposes of regulatory 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 responsibilitiesfor clinical trials that such Party sponsors, and each Party shall be solely granted access to any safety database relating to the Zaiming Product held by the other Party; and (y) with respect to NextCure Product, NextCure shall hold and be 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 the global safety information database for the NextCure Product, and that Zaiming or NextCure, as applicable, shall hold and be responsible for the exchange maintenance of Safety Data a safety database for the purposes of regulatory reporting for clinical trials that such Party sponsors, and each Party shall be granted access to any safety database relating to all Compoundsthe NextCure Product held by the other Party, 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 provide that the reporting requirements of all applicable Regulatory Authorities on sponsoring Party for a worldwide basis clinical trial shall be responsible for the safety reporting for the clinical trial and shall lead all pharmacovigilance activities for such trial, and (iii) include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Safety Data adverse event reports, pregnancy reports, and any other information concerning the safety of the Licensed Product. Such guidelines and procedures shall be in accordance with standards stipulated in the ICH guidelineswith, and all applicable enable the Parties and their Affiliates to fulfill, local and international 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 AMENDEDreporting obligations to government authorities.

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.

Adverse Event Reporting. Pharmacovigilance ‌ 7.1 The responsibilities of the Parties for reporting of Human Safety Information related to the Product(s) to Relevant Regulatory Authorities shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Product related inquiries shall be performed in accordance with local laws and regulations. 7.2 Without prejudice to Clause 7.1: - The Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures, training programmes and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. AMAG shall be solely responsible for maintaining - The Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the global Product(s) in the Territory including without limitation those laws and regulations relating to risk management, drug safety and Pharmacovigilance.This includes but is not limited to collating Human Safety Information, expedited and periodic reporting to relevant Regulatory Authorities, literature review, performing safety evaluation and signal detection on all available Human Safety Information - The Licensee will hold and maintain a safety database for Products. […***…]. As between regarding 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 Products in the Territory; , which shall contain all Human Safety Information (for marketed Product(s)) and all Serious Adverse Events (bSAEs) Palatin and Pregnancy Reports (for investigational Product(s)) of which the Licensee becomes aware either directly or its licensee(s) from another source. - The Licensee shall provide the Licensor and ViiV with a report containing information regarding Human Safety Information which are associated with the Products and which have been received by the Licensee, from any source, including spontaneous, solicited, and clinical trial sources. Such report shall be responsible for provided annually and otherwise on reasonable request by the pharmacovigilance surveillance Licensor and/or ViiV. - The Licensee shall notify the Licensor and timely reporting ViiV forthwith of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data the receipt of an enquiry from a Relevant Regulatory Authority relating to the Product that concerns any Compound, safety issue. If the Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the 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 it 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 immediately 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.any event no later than twenty-four

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 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 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.

Adverse Event Reporting. 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 each Combined Therapy, and to execute a written Pharmacovigilance Agreement (“PVA”) within [**] 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. AMAG Such PVA shall be solely responsible for maintaining the global safety database for Products. […***…]. As between the Parties: (a) AMAG provide that Recipient shall hold and be responsible for the maintenance of the Global Safety Database for the Recipient Study Drug and that BMS shall hold and be responsible for the maintenance of the Global Safety Database for the BMS Study Drug, (b) provide that Recipient shall be responsible for the safety reporting for the Combined Therapy and shall lead all pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiencesactivities for the Combined Therapy, Product quality, Product complaints and (c) permit Recipient to disclose or otherwise make available [**] information in the Global Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device Database applicable to the appropriate Regulatory Authorities in the Territory; Recipient Study Drug, and (bd) Palatin or its licensee(sinclude 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 responsible 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 or Applicable Law, in which case local reporting requirements or Applicable Law shall prevail. In the pharmacovigilance surveillance event of a conflict between the terms this Agreement and timely reporting the terms of all relevant adverse drug reactions/experiencesthe PVA, Product quality, Product complaints and Safety Data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device the PVA shall supersede to the appropriate Regulatory Authorities outside extent related to pharmacovigilance matters associated with the Territory, in each case in accordance with applicable Laws. The Parties shall cooperate with each other Combined Therapy Clinical Trial and the terms of this Agreement control 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 any other matters. In the Parties in writing. Within […***…] after the Effective Dateevent that this Agreement is terminated, the Parties shall enter into a agree to implement the necessary procedures and practices to ensure that any outstanding 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 AMENDEDobligations are fulfilled.

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall be solely responsible for maintaining the global safety database for Products. […***…]. As between the Parties, unless otherwise agreed by the Parties in the Pharmacovigilance Agreement: (a) AMAG shall ▇▇▇▇▇ shall, by itself or through a Third Party vendor, be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product product quality, Product product complaints and Safety Data safety data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device the Compound and Products to the appropriate Regulatory Authorities in outside the Territory, at ▇▇▇▇▇’▇ costs and expenses; and (b) Palatin Everest shall, by itself or its licensee(s) shall through a Third Party vendor, be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, Product product quality, Product product complaints and Safety Data safety data relating to any Compound, Product, Pharmaceutical Product or Product Delivery Device the Compound and Products to the appropriate Regulatory Authorities outside in the TerritoryTerritory at Everest’s cost and expenses, in each case in accordance with applicable LawsLaw of the relevant countries and Regulatory Authorities. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Everest shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Products outside the Territory. Each Party shall be solely responsible for all costs relating it incurs to conduct 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 guidelinesguidelines (the “Pharmacovigilance Agreement”), including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data safety data relating to all Compounds, Products, Pharmaceutical the Compound and 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 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 AMENDEDsafety data for a trial of the applicable type.