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 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. 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: (a) AMAG shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant You must submit 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 experience reports in accordance with applicable Lawsthe adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports as described in 21 CFR 600.81. For information on adverse experience reporting, please refer to the guidance for industry Providing Submissions in Electronic Format —Postmarketing Safety Reports for Vaccines at https://www.fda.gox/xxxxxxxxxx-xxxxxxxxxxx/search-fda-guidance-documents/providingsubmissions-electronic-format-postmarketing-safety-reports-vaccines. For information on distribution reporting, please refer to the guidance for industry Electronic Submission of Lot Distribution Reports at http://www.fda.gov/XxxxxxxxxXxxxxXxxxxxxx/GuidanceComplianceRegulatoryInformation /Post-MarketActivities/LotReleases/ucm061966.htm. TROPICAL DISEASE PRIORITY REVIEW VOUCHER We also inform you that you have been granted a tropical disease priority review voucher (PRV), as provided under section 524 of the FDCA. This PRV has been assigned a tracking number, PRV BLA 125690. All correspondences related to this voucher should refer to this tracking number. This voucher entitles you to designate a single human drug application submitted under section 505(b)(1) of the FDCA or a single biologic application submitted under section 351 of the Public Health Service Act as qualifying for a priority review. Such an application would not have to meet any other requirements for a priority review. The Parties shall cooperate list below describes the sponsor responsibilities and the parameters for using and transferring a tropical disease PRV. • The sponsor who redeems the PRV must notify FDA of its intent to submit an application with each other a PRV at least 90 days before submission of the application and must include the date the sponsor intends to submit the application. This notification should be prominently marked, “Notification of Intent to Submit an Application with respect a Tropical Disease Priority Review Voucher.” • This PRV may be transferred, including by sale, by you to their respective pharmacovigilance responsibilitiesanother sponsor of a human drug or biologic application. If the PRV is transferred, the sponsor to xxxx xxx XXV has been transferred should include a copy of this letter (which will be posted on our website as are all approval letters) and proof that the PRV was transferred. When redeeming this PRV, you should refer to this letter as an official record of the voucher. For additional information regarding the PRV, see FDA's guidance, Tropical Disease Priority Review Vouchers, at http://www.fda.gov/xxxxxxxxx/Xxxxx/XxxxxxxxXxxxxxxxxxXxxxxxxxxxXxxxxxxxxxx/Guida nces/UCM080599.pdf. PEDIATRIC REQUIREMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. We are waiving the pediatric study requirement for ages 0 through 11 months because necessary studies are impossible or highly impracticable. We are deferring submission of your pediatric study for ages 12 months through 16 years of age for this application because this product is ready for approval for use in adults and the pediatric study has not been completed. Your deferred pediatric study required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) is a required postmarketing study. The status of this postmarketing study must be reported according to 21 CFR 601.28 and section 505B(a)(4)(c) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials. Label your annual report as an “Annual Status Report of Postmarketing Study Requirement/Commitments” and submit it to the FDA each Party shall be solely responsible for costs relating year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject 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 under section 506B 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 DataFDCA are released or fulfilled. 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.This required study is listed below:

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 Xxxxx 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 Xxxxx’x 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.

Adverse Event Reporting. Pharmacovigilance Agreement. AMAG shall (a) During the Term prior to the Transfer Date, (i) EyePoint will be solely responsible at its sole cost for maintaining the global safety adverse event database for Products. […***…]. As between YUTIQ, and (ii) EyePoint, as the Parties: (a) AMAG holder of the YUTIQ NDA and the YUTIQ China NDA, shall be responsible for the pharmacovigilance surveillance and timely complying with any safety 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 obligations to the appropriate Regulatory Authorities in FDA and NMPA with respect to YUTIQ, subject to receipt of any information required to be provided by Alimera under the Territory; Existing Pharmacovigilance Agreement. EyePoint shall consult with Axxxxxx and take into account any and all comments from Alimera with respect to such reports prior to making any such reports. (b) Palatin or its licensee(s) shall During the Term following the Transfer Date, and subject to any assistance to be provided by EyePoint under the Transition Services Agreement, Alimera will be responsible at its sole cost for maintaining the global adverse event database for the pharmacovigilance surveillance Products, and timely reporting of all relevant adverse drug reactions/experiencesfollowing the applicable YUTIQ IND and NDA Transfer Effective Date, Product quality, Product complaints and Safety Data relating subject to any Compoundassistance to be provided by EyePoint under the Transition Services Agreement, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities outside the Territory, in each case exchanging safety data with Ocumension in accordance with applicable Lawsthe terms of the Ocumension PV Agreement and complying with any safety reporting obligations to Regulatory Authorities with respect to the Products in the Field in the Licensed Territory. 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 terminate the Effective DateExisting Pharmacovigilance Agreement when appropriate. (c) During the Transition Period, the Parties Alimera shall enter into make arrangements, either by itself or through a pharmacovigilance agreement on terms that comply with ICH guidelinesThird Party service provider, including: (i) providing detailed procedures regarding the maintenance of core to be able to receive and process safety information for YUTIQ in the Licensed Territory and the exchange Ocumension Territory following the Transition Period. Upon the request of Safety Data relating to all CompoundsAxxxxxx, 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 “EyePoint will […***…]”. 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] enable Axxxxxx, AS AMENDEDat Axxxxxx’s sole cost, to contract directly with EyePoint’s existing Third Party service provider to receive and process safety information for YUTIQ in the Licensed Territory and the Ocumension Territory.

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 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 Agreement. AMAG shall be solely responsible for maintaining During the global safety database for Products. […***…]. As between the Parties: (a) AMAG shall be responsible for the pharmacovigilance surveillance Term, The Parties agree to comply with any 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 Applicable Laws then applicable to the appropriate Regulatory Authorities in the Territory; Licensed Product safety data collection 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 Lawsreporting. The Parties shall cooperate with each other with respect to (or their respective Affiliates) will execute a safety and pharmacovigilance responsibilitiesagreement (the “Safety and Pharmacovigilance Agreement”) prior to the initiation of clinical activities by CASI, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties but in writing. Within […***…] any event within ninety (90) days 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 to ensure the exchange of Safety Data relating to all Compounds, Products, Pharmaceutical Products and Product Delivery Devices worldwide relevant safety data within appropriate timeframes time frames and in an appropriate format to enable each Party the Parties to meet both expedited fulfill local and periodic international regulatory reporting requirements; obligations and to facilitate appropriate safety reviews. In the event of any inconsistency between the terms of this Agreement and the Safety and Pharmacovigilance Agreement, the terms of this Agreement shall govern, except to the extent such conflicting terms relate directly to the pharmacovigilance responsibilities of the Parties (ii) ensuring compliance including the exchange of safety data), in which case the terms of the Safety and Pharmacovigilance Agreement shall govern. The Safety and Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any Adverse Events, pregnancy reports, and any other safety information arising from or related to the use of the Licensed Product, consistent with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data Applicable Law. 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 reporting obligations to Regulatory Authorities. The information exchanged between the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Parties pursuant to this Section 7.5 shall be transmitted by email, facsimile or overnight courier to the following address: Transmission to Cleave: ​ Cleave Therapeutics, Inc. 000 Xxxx Xxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, XX 00000 Attn: Chief Operating Officer Email: […***…]”. 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] ​ Transmission to CASI: ​ CASI Pharmaceuticals, AS AMENDED.Inc. 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxx 000 Xxxxxxxxx, XX 00000 Attn: Chief Medical Officer Email: [***] ​

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.