Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. (a) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a database.

Pharmacovigilance. No later than [***] prior to (a) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by [***] or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]. (c) Without limiting Sections 4.5(a) will negotiate in good faith and (b) above, within a reasonable period of time following finalize the Effective Date (with actions that the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database Parties will employ with respect to the Licensed Product Products to protect patients and promote their well-being in such Party’s Territorya written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and shall exchange any safety data timely (as established in the pharmacovigilance agreement between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes, and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Lyra will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The pharmacovigilance agreement shall include provisions Pharmacovigilance Agreement will also provide for a worldwide safety database to facilitate be maintained by Lyra at its sole cost and ensure that each expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees, and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement, and comply with all applicable Law. Each Party has sufficient information will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to maintain comply with such a databaseobligations.

Pharmacovigilance. (a) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints Orexigen and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall enter Takeda entered into a pharmacovigilance agreement effective as of September 10, 2014 (as may be amended by the Parties in accordance with its terms, the “Pharmacovigilance Agreement”) concerning all matters relating to management and exchange of safety information on terms no less stringent than those required by applicable ICH Guidelinesguidelines. Takeda shall be responsible, including: [***]. at its own expense, for the establishment and maintenance of the global safety database for Products in all Indications in the Territory. Each Party shall cooperate (c) Without limiting Sections 4.5(a) at its sole cost and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]expense), each Party and shall establish cause its Affiliates, licensees, and thereafter maintain sublicensees to cooperate, in implementing a safety database pharmacovigilance mutual alert process with respect to the Licensed Product Products and to comply with all applicable Laws. Generally, (a) prior to transfer of the Regulatory Filings as set forth in such Party’s Section 3.4.2, Orexigen shall be responsible for submitting all required IND safety reports contemplated by 21 C.F.R. 312.32, and post-marketing reports of adverse drug experiences contemplated by 21 C.F.R. 314.80, or the foreign equivalent in the Territory, and shall exchange any safety data timely as established relating to Products to the appropriate Regulatory Authorities in the pharmacovigilance agreement between Territory, in accordance with applicable Laws; (b) following transfer of the PartiesRegulatory Filings as set forth in Section 3.4.2, and with respect to any other Regulatory Filings, Takeda shall be responsible for reporting all adverse drug reaction experiences required to be reported to the appropriate Regulatory Authorities in the Territory in which such Product is being Developed or Commercialized, in accordance with Laws; and (c) Orexigen, its Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, including any post-marketing reports of adverse drug experiences, relating to Products and required to be reported to the appropriate regulatory authorities outside of the Territory, in accordance with the Laws of the relevant countries. Orexigen shall have the right to share any and all information received from Takeda under this Section 3.6, or the Pharmacovigilance Agreement, with Orexigen’s Affiliates and licensees and sublicensees outside the Territory. Takeda shall have the right to share any and all information received from Orexigen under this Section 3.6 or the Pharmacovigilance Agreement with Takeda’s Affiliates and Sublicensees in the Territory. The JSC shall review from time to time Takeda’s and Orexigen’s pharmacovigilance agreement shall include provisions to facilitate policies and ensure that procedures. The Pharmacovigilance Agreement identifies the responsibilities of each Party has sufficient regarding the information to maintain be exchanged and the timeframes for such a databaseexchange, regulatory reporting, literature review, risk management, and labeling.

Pharmacovigilance. In no event later than twelve (a12) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basis. (b) Following months after the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: concerning all matters relating to the pharmacovigilance and the exchange of all relevant Information that relates to the safety of each Product worldwide and especially all adverse events and which will provide that (a) Distributor will liaise with Coherus’ pharmacovigilance provider for its reporting obligations[***]. , (b) Distributor shall be responsible for reporting all adverse drug reaction experiences required to be reported to the appropriate Regulatory Authorities in the countries in the Territory in which such Product is being Commercialized, in accordance with the Applicable Laws of the relevant countries and Regulatory Authorities in coordination with Coherus and with the review and final approval by Coherus of any such reporting; and (c) Without limiting Sections 4.5(aCoherus, its Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, including without limitation any post-marketing reports of adverse drug experiences, relating to such Product required to be reported to the appropriate regulatory authorities outside of the Territory in accordance with the Applicable Laws of the relevant countries. Each Party shall have the right to share any and all information received from the other Party under this Section 3.7 (and/or such pharmacovigilance agreement) with its Affiliates and licensees and sublicensees, including without limitation, permitted Sublicensees. Coherus shall review from time to time Distributor’s pharmacovigilance policies and procedures. Subject to the requirements of Section 11.3 (bTermination for Material Breach) aboveincluding the requirement of providing written notice and the entitlement of a cure period, in the event that [***] rate of reported serious adverse events within a reasonable period of time following country within the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior Territory for a Product compared to [***]), each Party Coherus shall establish have the right to terminate all rights granted to Distributor under this Agreement with respect to such Product in such country, and thereafter maintain a safety database Section 11.6 (Consequences of Termination) shall apply with respect to such Product in such country. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databaseomitted portions.

Pharmacovigilance. (a) Each Party 4.5.1 Genzyme and its Affiliates will be responsible for continuing all pharmacovigilance activities with respect to Aldurazyme, including without limitation maintaining Aldurazyme Core Safety Information. BioMarin shall have the right to audit, at any time during regular business hours and upon reasonable advance notice to audit such pharmacovigiliance activities with respect to Aldurazyme. Such audit rights shall include the right to review, inspect and/or audit any systems or processes involved or utilized in such pharmacovigilance activities as well as the right to review, inspect or audit all information or data necessary to be filed with any regulatory or governmental authority. 4.5.2 In the event that the Aldurazyme Labeling Materials must be updated per new Core Safety Information, after receipt of all necessary information and data from Genzyme, BioMarin agrees to use its commercially reasonable and diligent efforts make all necessary regulatory filings to FDA and obtain approvals in order to ensure the content of Aldurazyme Labeling Materials in the United States is in-line with the Core Safety Information. Genzyme shall be responsible for all pharmacovigilance activities associated with using its commercially reasonable and diligent efforts to make such filings and obtain such approvals outside of the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory)United States. Each Party of BioMarin and Genzyme shall promptly notify be given the opportunity to attend and participate in any meetings or discussions that the other Party with respect to any material safety changes or material safety issues that may arise in connection have with any IND for regulatory authorities regarding any submissions or approvals and shall be provided with an opportunity to review and comment upon any correspondence, submission or communication that the Licensed Product filed by other Party may have with any such regulatory authority prior to such correspondence, submission or under the authority communication being made or submitted to such regulatory authority. 4.5.3 As of the first PartyEffective Date and throughout the term of this Agreement, and/or Genzyme shall maintain one or more written SOP(s) to collect Adverse Experience information. The content of any Regulatory Approvals SOP(s) shall include, but not be limited to, specific instructions regarding the type of Adverse Experience information collected, the time frame for the Licensed Productcollection, in any country within its territoryprovisions for secure transmissions, and inter-company processes to be used for notification of said information. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect In addition to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]foregoing, the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by update the current guidelines and procedures to govern receipt, processing, assessment and submission of Aldurazyme Adverse Experience and Serious Adverse Experience reports to the FDA, the European Commission and other regulatory authorities within sixty (60) days after the Effective Date. Procedures described therein shall ensure compliance with all applicable ICH Guidelines, including: [***]. (c) Without limiting Sections 4.5(a) laws and (b) above, within a reasonable period regulations. The Parties acknowledge that Genzyme’s SOPs as they exist as of time following the Effective Date (with satisfy the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect requirements of this Section 5.2.1 for reports to the Licensed Product in FDA. 4.5.4 BioMarin shall have responsibility for filing all 15-day alert reports, 15-day alert follow-up reports and periodic adverse event reports to the FDA per 21 CFR §600.80. Genzyme or its designee shall have responsibility for filing such Party’s Territoryreports outside of United States, including EMEA and shall exchange any safety data timely as established in other regulatory authorities according to the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databaselocal regulations.

Pharmacovigilance. (a) Each Party shall be responsible for all pharmacovigilance activities associated with Promptly after the Licensed Product in its respective territoryEffective Date, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant and their respective Affiliates shall appoint a joint safety governance team (the “Safety Team”) comprised of an equal number of representatives of each Party to Section 4.5(bdiscuss (i) below, to enable Licensee to meet its regulatory reporting requirements the exchange of safety information with respect to the core Licensed Products and AstraZeneca Products and (ii) the negotiation of a written safety management agreement (the “Pharmacovigilance Agreement”), which shall be agreed and executed as promptly as practicable following the Effective Date but in any event no later than [***] after the Effective Date. The Safety Team shall be advisory only and shall not have any decision-making authority. The Pharmacovigilance Agreement will (A) address the Parties’ responsibilities in the Territory in relation to pharmacovigilance obligations for the Development and Commercialization of Licensed Compounds and Licensed Products and AstraZeneca Products in the Territory under 21 C.F.R. sections 312.32 or 314.80 or under corresponding Applicable Law outside the United States) with respect to pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product on a global basisand AstraZeneca Products and (B) include such specific responsibilities of the Safety Team and such guidelines for the operation of the Safety Team as the Parties may agree. (b) Following Notwithstanding Section 3.4.4(a), Licensee shall establish, hold and maintain a safety database for the Effective DateLicensed Compounds and Licensed Products and Licensee shall be solely responsible for complying with its pharmacovigilance responsibilities in the Territory, with as applicable. MedImmune and its Affiliates shall have the precise timing right, during normal business hours and upon reasonable notice, to be mutually agreed upon by the Partiesaccess and copy safety *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, but in any event prior to MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. reporting information for the Licensed Products in the Territory. To the extent reasonably required by Licensee in relation to the Exploitation of a Licensed Product or obtaining and maintaining Regulatory Approval for a Licensed Product, MedImmune shall cooperate in good faith to provide Licensee with appropriate access to material safety reporting information for the AstraZeneca Product solely for use in relation to the Exploitation of a Licensed Product in accordance with the terms of this Agreement. (c) With respect to any AstraZeneca Product, unless otherwise agreed by the Parties in writing, Licensee shall enter into notify in writing MedImmune or such Affiliate as MedImmune may designate of any adverse events and other safety-relevant information and complaints associated with such AstraZeneca Product in the Territory (each, a pharmacovigilance agreement on terms no less stringent than those required by “Spontaneous Adverse Event”) of which Licensee becomes aware, outside the conduct of clinical studies within [***] after Licensee first learns of such Spontaneous Adverse Event. (d) Licensee shall notify MedImmune according to the timelines above, regardless of seriousness, causality, and whether or not the AstraZeneca Product was used in accordance with the authorized Summary of Product Characteristics (SPC) or any other conditions laid down for marketing of the AstraZeneca Product in accordance with applicable ICH Guidelines, legal requirements including: (i) reports of suspected transmission of an infectious agent for the AstraZeneca Product and (ii) reports of lack of effect, pregnancy, lactation/paternal exposure, medication error, overdose, off-label use, drug interaction, abuse or misuse of the AstraZeneca Product, falsified/counterfeit product, or occupational exposure with or without an associated adverse event of the AstraZeneca Product. (e) Additionally, unless otherwise agreed, Licensee shall notify in writing MedImmune or such Affiliate as MedImmune may designate, of any serious adverse events and other safety-relevant information and complaints associated with such AstraZeneca Product in the Territory (each, a “Serious Adverse Event”) of which Licensee becomes aware under the conduct of clinical studies within timelines set forth on Schedule 3.4.4(e), after Licensee first learns of such Serious Adverse Event, as a processed report (e.g., CIOMS or E2B file). (f) Licensee shall notify in writing MedImmune of any other safety-relevant information and complaints associated with such AstraZeneca Product in the Territory that is not a Serious Adverse Event (each, an “Other Adverse Event”) of which Licensee becomes aware in the course of conducting clinical trials promptly after Licensee first learns of such Other Adverse Event. (g) Licensee shall cooperate with MedImmune to investigate and follow-up on any such Serious Adverse Events or Other Adverse Events associated with such AstraZeneca Product. For clarity, MedImmune or its Affiliate shall have final decision-making authority as to whether and how to report safety information pertaining to *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. any AstraZeneca Product, and Licensee shall have final decision-making authority as to whether and how to report safety information pertaining to any Licensed Product. (ch) Without limiting Sections 4.5(a) limitation to any of the foregoing, Licensee shall ensure that all applicable patient authorizations and (b) aboveconsents required under Applicable Law, within a reasonable period including the Health Insurance Portability and Accountability Act of time following 1996 and the Effective Date (EU Data Protection Directive 95/46/EC, in connection with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect information pertaining to the Licensed Product in Compounds and Licensed Products from any sources, permit such Party’s Territorysharing of safety information with MedImmune or its Affiliate, and shall exchange any safety data timely as established in including patient information required to contact the pharmacovigilance agreement between reporter where the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such source is outside the conduct of a databaseclinical study.

Pharmacovigilance. Arena or its Arena ex-Territory Distributors shall be responsible, at its own expense, for all required safety reporting with respect to each Product in each country outside of the Territory. Promptly after the 2nd Amendment Effective Date, (a) Each Arena shall cooperate towards the orderly transfer to Eisai, or the establishment by Eisai, of the global safety database for the Product, and thereafter, Eisai shall be responsible at its expense for maintaining the global safety database and (b) the Parties shall amend and restate the PV Agreement to address the exchange of safety information with respect to the Product in the Territory (including with respect to Arena’s current and future ex-Territory Distributors). As between the Parties, the Party holding the relevant IND will be responsible for all safety reporting for clinical development (unless otherwise agreed to by the Parties) in the Territory and will assume all such expenses associated with safety reporting in the Territory. Eisai (or its designated Affiliate or Sub-distributor) will be responsible for all safety reporting relating to Commercialization of the Product in the Territory and will assume all such expenses associated with safety reporting in the Territory. Eisai shall be responsible for all ensuring compliance by its Affiliates or Sub-distributors with respect to pharmacovilgilance responsibilities under the PV Agreement and Applicable Law in the applicable countries in the Territory. Arena shall be responsible for ensuring compliance by Arena ex-Territory Distributors with respect to pharmacovigilance activities associated with responsibilities under the Licensed Product PV Agreement and Applicable Law in its respective territorythe ex-Territory countries, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including safety reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory)requirements. Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party cooperate and shall ensure that cause its Affiliates and licensees (and, in the case of LicenseeArena, all Related Partiesshall cause the Arena ex-Territory Distributors, and in the case of Eisai, shall cause the Sub-distributors) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on to cooperate in implementing a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements mutual alert process with respect to the core safety management for Products. Arena and Eisai shall each have the Licensed right to subcontract any such activities to a Third Party. Further, the PV Agreement shall provide: (a) a Joint Product on Safety Committee (the “JPSC”) will be established by the Parties as a global basis. JDC Subcommittee with representatives from Eisai and Arena (including pharmacovigilance, regulatory, medical affairs and legal representatives); (b) Following the Effective DateJPSC shall seek to act by consensus whenever possible, with Eisai representatives having final decision-making authority; (c) Arena shall have the precise timing right to have its or its Affiliate’s personnel interact on a regular basis with Eisai’s operational safety team for the Products; (d) Arena shall have the right to maintain an informational database with a copy of all global safety reports; (e) Eisai will generate aggregate reports and for those reports to be mutually agreed upon by the Parties, but in any event prior submitted to [***], ex-Territory countries provide Arena a reasonable amount of time to review and comment on such reports (and the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required seek to reach conclusions by applicable ICH Guidelinesconsensus, including: [***]. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a database.Eisai having final decision-

Pharmacovigilance. (a) Each Party Asahi, as the holder of the Product Approvals, shall be responsible for all pharmacovigilance activities the collection, review, assessment, tracking and filing of information related to adverse events associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Territory (whether or not Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed ProductApproval has been achieved), in its territory each case in accordance with Laws and this Agreement (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party Asahi shall ensure that its Affiliates and licensees (andthat, in the case Development and Commercialization of Licenseethe Product, it will record, investigate, summarize, notify, report and review all Related Partiesadverse events in accordance with Laws). Auxilium (or its designee) comply with such reporting obligations. Licensee shall be responsible for core the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory. The safety management units from each of the Licensed Product on Parties shall meet and agree upon a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any written pharmacovigilance agreement executed by for exchanging adverse event and other safety information relating to the Parties pursuant Product prior to Section 4.5(b) belowAsahi’s first clinical activity or prior to the first Regulatory Approval in the Territory (whichever is first). Such written pharmacovigilance agreement shall ensure that adverse event associated with the Product and other safety information is exchanged according to a schedule that will permit each Party (and its designees or, to enable Licensee to meet its regulatory reporting requirements solely with respect to the core safety management for the Licensed Product on a global basisAuxilium, its sublicensees) to comply with Laws and regulatory requirements in their respective markets. (b) Following Notwithstanding the Effective Dateforegoing, with or anything else to the precise timing contrary contained herein, in the event that, at any time during the Term, Asahi receives a notification from a Governmental Authority (including, for clarity, a Regulatory Authority) indicating that Asahi’s pharmacovigilance infrastructure or implementation is in violation of applicable Laws or is otherwise subject to be mutually agreed upon investigation by such Governmental Authority, then Auxilium shall have the Partiesoption, but in any event prior not the obligation, to [***]assume, to the Parties shall enter into a extent that such assumption is not prohibited by Laws, responsibility for pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in the Field in the Territory including the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Field in the Territory (whether or not Product Approval has been achieved). If Asahi receives such Party’s Territorya notification and Auxilium desires to exercise such option, then the Parties shall promptly meet to discuss the transfer of pharmacovigilance oversight in the Territory with respect to the Product in the Field to Auxilium, and shall exchange any safety data timely as established ensure that such transfer is in compliance with all Laws; furthermore, Asahi shall provide all assistance requested by Auxilium in conducting such pharmacovigilance activities in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databaseTerritory.

Pharmacovigilance. (a) Each Party The Parties will enter into a pharmacovigilance agreement within [***] after the License Agreement Effective Date that shall govern their obligations with respect to the exchange, handling and reporting of adverse events, other safety information and Licensed Product complaints during Development and Commercialization of the Licensed Candidates and Licensed Products in each Party’s territory (the “Pharmacovigilance Agreement”). In general, the Pharmacovigilance Agreement will provide that (i) [***] will be responsible for such obligations within the ROW Territory, and [***] will be responsible for such obligations outside the ROW Territory. [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products in the ROW Territory, and be responsible for all pharmacovigilance activities associated with for the Licensed Candidates and Licensed Products in the ROW Territory, (ii) [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products outside the ROW Territory, and be responsible for all pharmacovigilance activities for the Licensed Candidates and Licensed Product in its respective territoryoutside the ROW Territory, including filing and (iii) [***] will establish and maintain a global safety database for Licensed Candidates and Licensed Products that will contain all reports information and data arising from the Parties’ activities with respect to safety matters that is required to be filed in order to maintain any IND for the Licensed Product filed contributed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating each Party pursuant to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to Pharmacovigilance Agreement, including information and data arising out of any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basismonitoring activities. (b) Following The Parties shall discuss, through the Effective DateJRDC, and agree upon standard provisions reasonably acceptable to both Parties regarding: (i) [***] in connection with Licensed Candidates, Licensed Products or Licensed Diagnostic Products [***]; and (ii) [***] which may result in [***] each Party with respect thereto. (c) Each Party shall inform the other Party during the License Term, in accordance with the precise timing Pharmacovigilance Agreement, of the side effect profiles for Licensed Candidates and Licensed Products, including pregnancy and suspected pregnancy, damages, toxicity or sensitivity reactions associated with the use of any Licensed Candidate or Licensed Product, regardless of whether these effects are attributable to be mutually agreed upon by such Licensed Candidate or Licensed Product. Each Party shall have the Parties, but in any event prior right to take [***], including the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelinesright to [***] of such Licensed Candidate or Licensed Product, including: if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***]. (cd) Without limiting Sections 4.5(aIn accordance with the procedures established by the Parties under the Pharmacovigilance Agreement, each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Licensed Candidate and Licensed Product. Each Party shall: (i) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product and any actions taken in response to such information; (ii) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product [***], as far as this concerns [***]; and (biii) abovetimely provide the other Party with [***] such Licensed Candidate or Licensed Product of which the [***], within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior as far as this relates to [***])] to perform their obligations or exercise their rights under this License Agreement. Treatment of safety information, each Party standard operating procedures and training, as well as a statement of respective regulatory obligations shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established be agreed in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databasePharmacovigilance Agreement.

Pharmacovigilance. (a) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, As soon as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Partiespossible, but in any event prior to no later than [***], the Parties Orexigen and Takeda shall enter into a pharmacovigilance agreement concerning all matters relating to management and exchange of safety information on terms no less stringent than those required by applicable ICH Guidelinesguidelines. Takeda shall be responsible, including: [at its own expense, for the ***]. (c) Without limiting Sections 4.5(a) * Certain information on this page has been omitted and (b) above, within a reasonable period of time following the Effective Date (filed separately with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database Commission. Confidential treatment has been requested with respect to the Licensed Product omitted portions. establishment and maintenance of the global safety database for Products in such Party’s all Indications in the Territory. Each Party shall cooperate (at its sole cost and expense), and shall exchange cause its Affiliates, licensees and sublicensees to cooperate, in implementing a pharmacovigilance mutual alert process with respect to the Products and to comply with all applicable Laws. Generally, (a) prior to transfer of the Regulatory Filings as set forth in Section 3.4.2, Orexigen shall be responsible for submitting all required IND safety reports contemplated by 21 C.F.R. 312.32, and post-marketing reports of adverse drug experiences contemplated by 21 C.F.R. 314.80, or the foreign equivalent in the Territory, relating to Products to the appropriate Regulatory Authorities in the United States, in accordance with applicable Laws; (b) following transfer of the Regulatory Filings as set forth in Section 3.4.2, and with respect to any safety data timely as established other Regulatory Filings, Takeda shall be responsible for reporting all adverse drug reaction experiences required to be reported to the appropriate Regulatory Authorities in the countries in the Territory in which such Product is being Developed or Commercialized, in accordance with the Laws of the relevant countries; and (c) Orexigen, its Affiliates or licensees or sublicensees shall be responsible for submitting all regulatory filings, including any post-marketing reports of adverse drug experiences, relating to Products and required to be reported to the appropriate regulatory authorities outside of the Territory, in accordance with the Laws of the relevant countries. Orexigen shall have the right to share any and all information received from Takeda under this Section 3.6, or the pharmacovigilance agreement entered into between the Parties, with Orexigen’s Affiliates and licensees and sublicensees outside the Territory. Takeda shall have the right to share any and all information received from Orexigen under this Section 3.6 or such pharmacovigilance agreement with Takeda’s Affiliates and Sublicensees in the Territory. The JSC shall review from time to time Takeda’s and Orexigen’s pharmacovigilance policies and procedures. The pharmacovigilance agreement shall include provisions to facilitate and ensure that identify the responsibilities of each Party has sufficient regarding the information to maintain be exchanged and the timeframes for such a databaseexchange, regulatory reporting, literature review, risk management, and labeling.

Pharmacovigilance. (a) Each Party Within a reasonable amount of time, not to exceed six (6) months from the Effective Date, the Parties shall be responsible agree upon and implement a procedure for all pharmacovigilance activities the mutual exchange of safety information associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for Products. The details of the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data operating procedures relating to the Licensed exchange shall be the subject of a mutually-agreed upon written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall govern the collaboration between the Parties enabling each to comply with its respective obligations under applicable laws, regulations and guidelines with regard to adverse event data collection, analysis and reporting. (b) It is further acknowledged and agreed that if the Parties enter into a Co-Detailing Agreement pursuant to the provisions set forth in Section 7.2(e) above, any such Co-Detailing Agreement shall specify that Array shall promptly report to Novartis any adverse events related to the use of the Product in its territory)conformity with the adverse event reporting procedures established by Novartis. Each Party In addition, each party shall promptly notify the other Party with respect to of any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect complaint relating to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon received by the Parties, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]Array. (c) Without limiting Sections 4.5(aThe Parties shall promptly inform each other (via their respective appointed pharmacovigilance representatives) of any new safety information, including without limitation, suspected serious adverse reactions (whether unexpected or not), clinical trial reports and/or ad interim analyses results and the timely notification of trial completion in accordance with all applicable law and regulations governing safety reporting, including relevant timelines. For clarity, in the event the Parties have executed a Pharmacovigilance Agreement, all relevant safety findings (bboth clinical and pre-clinical) aboveshould be included in periodic reports per the detailed Pharmacovigilance Agreement and regulatory requirements. (d) The Parties shall promptly inform each other (via their respective appointed pharmacovigilance representatives) of any safety issues and/or actions planned or taken for reasons of patient safety, including documentation such as Dear Doctor Letters and any changes to the safety profile of the Product, as documented in the current product label or investigator brochure in accordance with applicable law and regulations governing safety reporting, including relevant timelines, as may be further detailed in a separate pharmacovigilance agreement. (e) The Parties agree that within a reasonable period of time ninety (90) days following the Effective Date Date, Array will transition to Novartis its global database and following such transition, Novartis will hold the global database, be primarily responsible for authoring of the Periodic Safety Update Report and be responsible for the Core Data Sheet and Investigator Brochure. (f) The Parties agree that its pharmacovigilance systems/operations or contracted pharmacovigilance activities will be audited at reasonable intervals to ensure elements set forth in the Pharmacovigilance Agreement are being fulfilled for the appropriate product. Both Parties will discuss and agree in good faith on how such an audit will be conducted (audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of ninety (90) days notice. Audits must be reasonable in scope and in relationship to the Product and must take place during normal business hours. Parties will correct audit observations in a timely manner and communicate those actions to the other Party. (g) Each Party shall provide the other with a notice in the event of a serious suspected breach of compliance with the precise timing to Pharmacovigilance Agreement. Within thirty (30) days following receipt of notice of such notice by a Party hereto, a directed audit will be mutually agreed upon performed by the Parties, but other party or an independent Third Party. (h) The Parties shall allow foreign and local health authorities to inspect their pharmacovigilance operations as it is necessary for either Party to maintain registration in any event prior to [***]), each the countries where the Product is marketed. A representative from the other Party shall establish and thereafter maintain a safety database with respect to the Licensed Product may participate in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Partiesinspections. The Parties shall communicate urgent or critical issues affecting the other Parties pharmacovigilance agreement shall include provisions to facilitate and ensure that each activities within fourteen (14) Business Days of receipt of documented findings cited during a health authority inspection. Once corrective actions are determined, the inspected Party has sufficient information to maintain such will provide a databasesummary of the relevant inspection findings with associated corrective actions where the other Party is impacted.

Pharmacovigilance. Within [***] after the Effective Date, Company and Licensee will negotiate in good faith and finalize the actions that Company and Licensee will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (athe “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between Company and Licensee) Each Party shall of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable Company and Licensee to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Licensee will be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territoryreporting quality complaints, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints Adverse Events and safety data relating related to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect Field to any material safety changes or material applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory; provided that may arise Licensee will conduct such activities (1) in connection with any IND for its own name, if Licensee is the Licensed Product filed by or under the authority legal and beneficial owner of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, Products in the case Field in the Territory or (2) as the express and authorized regulatory agent of Licenseerecord for Company in the Field in the Territory, all Related Parties) comply with if Company is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Territory, under which situation such reporting obligationsactions will be taken on behalf of Company and for the benefit of Licensee in the Field in the Territory. Licensee shall Company will be responsible for core reporting quality complaints, Adverse Events and safety management of the data related to Licensed Product to applicable Regulatory Authorities outside the Field in the Territory and outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Field in the Territory and outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Company at its sole cost and expense, to which Licensee shall contribute data in such form and format, and on a global basis; and Licensor shall cooperate with and assist Licenseesuch other terms, as provided in any pharmacovigilance agreement executed the Pharmacovigilance Agreement and which worldwide safety database will be accessible by Licensee, its Affiliates, Sublicensees and contractors to the Parties pursuant to Section 4.5(b) below, to enable full extent necessary for Licensee to meet exercise its regulatory reporting requirements rights under this Agreement, comply with respect to the core safety management for the Licensed Product on a global basis. (b) Following the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territoryits obligations under this Agreement, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Partiescomply with all applicable Laws. The pharmacovigilance agreement shall include provisions Each of Company and Licensee hereby agrees to facilitate comply with its respective obligations under such Pharmacovigilance Agreement and ensure that each Party has sufficient information to maintain cause its Affiliates and its and their sublicensees and contractors to comply with such a databaseobligations.

Pharmacovigilance. (a) Each Party Newsoara and its Affiliates shall be responsible for submitting all pharmacovigilance activities associated required Clinical Trial reports and post-marketing reports of adverse drug experiences relating to the Product to the appropriate Regulatory Authorities in the Territory in accordance with Applicable Laws and Guidelines in the Licensed Product Territory and requirements of Regulatory Authorities in the Territory. Newsoara and its respective territory, including filing Affiliates shall be responsible for reporting all reports adverse drug reaction experiences required to be filed reported to the appropriate Regulatory Authorities in order to maintain any IND the Territory in which the Product is being Developed for the Licensed Product filed by Initial Indication or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed ProductAdditional Indication or Commercialized, in accordance with Applicable Laws and Guidelines in the Territory. LBS shall provide to Newsoara, without additional charge, adequate information to support Newsoara’s reporting obligations in the Territory. Newsoara shall provide to LBS, without additional charge, adequate information to support LBS’s, its territory (Affiliates’, licensees’ and sublicensees’ reporting obligations outside the Territory. LBS, its Affiliates or licensees or sublicensees shall be responsible for submitting all Regulatory Filings, including reporting any post-marketing reports of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product required to be reported to the appropriate Regulatory Authorities outside of the Territory in its territory)accordance with the Applicable Laws and Guidelines of the relevant countries outside the Territory. Each Party LBS shall promptly notify have the other Party with respect right to share any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by and all information received from Newsoara under this Section 7.3 or under the authority of the first Party, Section 7.4 or Section 7.5 and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by between the Parties pursuant to Section 4.5(b) belowwith LBS’s Affiliates, to enable Licensee to meet its regulatory reporting requirements with respect to licensees and sublicensees outside the core safety management for the Licensed Product on Territory. Within a global basis. (b) Following reasonable period after the Effective Date, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***], the Parties shall will enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]customary terms. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a database.

Pharmacovigilance. (a) Each Subject to the terms of this Section 5.6.1, each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territorypharmacovigilance obligations under Applicable Laws. Licensee, including filing all reports required to be filed in order to maintain any IND for as the Licensed Product filed by or intended beneficiary under this Agreement of the authority privileges of such Party, and/or any ownership of the Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of LicenseeField in the Territory, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the Territory (whether or not Regulatory Approval has been achieved), in each case in accordance with Applicable Laws and this Agreement (and Licensee shall ensure that, in the Development and Commercialization of the Licensed Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws, including, for clarity, laws relating to adverse event reporting in the Territory). VBL (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product on in the countries outside the Territory. The safety units from each of the Parties shall meet and agree upon a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any written pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect for exchanging adverse event and other safety information relating to the core safety management for the Licensed Product on a global basis. (b) Following promptly following the Effective Date, and in any event, prior to Licensee’s first clinical activity or prior to the first Regulatory Approval in the Territory (whichever is first). Such written pharmacovigilance agreement shall ensure that adverse event associated with the precise timing Product and other safety information is exchanged according to be mutually agreed upon by the Parties, but a schedule that will permit each Party (and its designees or its sublicensees) to comply with Applicable Laws and regulatory requirements in any event prior to their respective markets. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***], the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines, including: [***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED. (c) Without limiting Sections 4.5(a) and (b) above, within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a database.

Pharmacovigilance. (a) Each Party The Parties will enter into a pharmacovigilance agreement within [***] after the License Agreement Effective Date that shall govern their obligations with respect to the exchange, handling and reporting of adverse events, other safety information and Licensed Product complaints during Development and Commercialization of the Licensed Candidates and Licensed Products in each Party’s territory (the “Pharmacovigilance Agreement”). In general, the Pharmacovigilance Agreement will provide that (i) [***] will be responsible for such obligations within the ROW Territory, and [***] will be responsible for such obligations outside the ROW Territory. [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products in the ROW Territory, and be responsible for all pharmacovigilance activities associated with for the Licensed Candidates and Licensed Products in the ROW Territory, (ii) [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products outside the ROW Territory, and be responsible for all pharmacovigilance activities for the Licensed Candidates and Licensed Product in its respective territoryoutside the ROW Territory, including filing and (iii) [***] will establish and maintain a global safety database for Licensed Candidates and Licensed Products that will contain all reports information and data arising from the Parties’ activities with respect to safety matters that is required to be filed in order to maintain any IND for the Licensed Product filed contributed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating each Party pursuant to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to Pharmacovigilance Agreement, including information and data arising out of any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Parties) comply with such reporting obligations. Licensee shall be responsible for core safety management of the Licensed Product on a global basis; and Licensor shall cooperate with and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect to the core safety management for the Licensed Product on a global basismonitoring activities. (b) Following The Parties shall discuss, through the Effective DateJRDC, and agree upon standard provisions reasonably acceptable to both Parties regarding: (i) [***] in connection with Licensed Candidates, Licensed Products or Licensed Diagnostic Products [***]; and (ii) [***] which may result in [***] each Party with respect thereto. (c) Each Party shall inform the other Party during the License Term, in accordance with the precise timing Pharmacovigilance Agreement, of the side effect profiles for Licensed Candidates and Licensed Products, including pregnancy and suspected pregnancy, damages, toxicity or sensitivity reactions associated with the use of any Licensed Candidate or Licensed Product, regardless of whether these effects are attributable to be mutually agreed upon by such Licensed Candidate or Licensed Product. Each Party shall have the Parties, but in any event prior right to take [***], including the Parties shall enter into a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelinesright to [***] of such Licensed Candidate or Licensed Product, including: if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***]. (cd) Without limiting Sections 4.5(aIn accordance with the procedures established by the Parties under the Pharmacovigilance Agreement, each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Licensed Candidate and Licensed Product. Each Party shall: (i) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product and any actions taken in response to such information; (ii) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product [***], as far as this concerns [***]; and (biii) abovetimely provide the other Party with [***] such Licensed Candidate or Licensed Product of which the [***], within a reasonable period of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior as far as this relates to [***])] to perform their obligations or exercise their rights under this License Agreement. Treatment of safety information, each Party standard operating procedures and training, as well as a statement of respective regulatory obligations shall establish be agreed in the Pharmacovigilance Agreement. [***] Certain information in this document has been omitted and thereafter maintain a safety database filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Licensed Product in such Party’s Territory, and shall exchange any safety data timely as established in the pharmacovigilance agreement between the Parties. The pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databaseomitted portions.

Pharmacovigilance. (a) Each Party Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required to be filed in order to maintain any IND for the Licensed Product filed by or under the authority of such Party, and/or any Regulatory Approvals granted for the Licensed Product, in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Licensed Product in its territory). Each Party shall promptly notify the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for the Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for the Licensed Product, in any country within . Syndax (or its territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of Licensee, all Related Partiesdesignee) comply with such reporting obligations. Licensee shall be responsible for core safety management the collection, review, assessment, tracking and filing of information related to adverse events associated with the Licensed Product on a global basis; in the countries outside the Territory as well as, to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. extent required under Applicable Law, compiling and Licensor communicating to Regulatory Authorities outside the Territory. KHK shall reasonably cooperate with and assist Licensee, Syndax upon request as provided required by Syndax in any pharmacovigilance agreement executed by the Parties pursuant order to Section 4.5(b) below, to enable Licensee to meet its comply with Syndax’s regulatory reporting requirements obligations with respect to the core safety management Product outside of the Territory. KHK shall be responsible for the Licensed Product on a global basis. (b) Following the Effective Datecollection, review, assessment, tracking and filing of information related to adverse events associated with the precise timing Product in the Field in the Territory. Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to be mutually agreed upon by the Parties, but in any event prior to [***]’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelines(the “PV Agreement”) containing the specific terms, including: [***]. (c) Without limiting Sections 4.5(a) conditions and (b) above, within a reasonable period obligations of time following the Effective Date (with the precise timing to be mutually agreed upon by the Parties, but in any event prior to [***]), each Party shall establish and thereafter maintain a safety database Parties with respect to the Licensed Product in such Party’s Territorycollection, reporting and shall exchange any monitoring of all adverse events, risk management activities and other relevant drug safety data timely as established in matters with respect to Products during the pharmacovigilance agreement between the PartiesTerm. The pharmacovigilance agreement PV Agreement shall include provisions to facilitate and ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party has sufficient information (and its designees or licensees) to maintain such a databasecomply with Applicable Law and regulatory requirements in their respective markets.