Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. Within [***] after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] 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 using its commercially reasonable and diligent efforts to make such filings and obtain such approvals outside of the United States. Each of BioMarin and Genzyme shall be given the opportunity to attend and participate in any meetings or discussions that the other Party may have with any 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 other Party may have with any such regulatory authority prior to such correspondence, submission or communication being made or submitted to such regulatory authority. 4.5.3 As of the Effective Date and throughout the term of this Agreement, Genzyme shall maintain one or more written SOP(s) to collect Adverse Experience information. The content of any SOP(s) shall include, but not be limited to, specific instructions regarding the type of Adverse Experience information collected, the time frame for collection, provisions for secure transmissions, and inter-company processes to be used for notification of said information. In addition to the foregoing, the Parties shall 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, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 Procedures described therein shall ensure compliance with all applicable Lawlaws and regulations. Each Party will comply with The Parties acknowledge that Genzyme’s SOPs as they exist as of the Effective Date satisfy the requirements of this Section 5.2.1 for reports to the 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 respective obligations under designee shall have responsibility for filing such Pharmacovigilance Agreement reports outside of United States, including EMEA and will cause its Affiliates and Sublicensees and contractors other regulatory authorities according to comply with such obligationsthe local regulations.

Pharmacovigilance. Within (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 [***] after the Effective Date], the Parties will negotiate 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 good faith any event prior to [***]), each Party shall establish and finalize the actions that the Parties will employ thereafter maintain a safety database with respect to the Licensed Products to protect patients Product in such Party’s Territory, and promote their well-being shall exchange any safety data timely as established in a written the pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos 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 will also provide for pharmacovigilance agreement shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsdatabase.

Pharmacovigilance. Within [***] In no event later than twelve (12) months after the Effective Date, the Parties shall enter into a pharmacovigilance agreement 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 negotiate 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 good faith the countries in the Territory in which such Product is being Commercialized, in accordance with the Applicable Laws of the relevant countries and finalize Regulatory Authorities in coordination with Coherus and with the actions review and final approval by Coherus of any such reporting; and (c) Coherus, 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 (Termination for Material Breach) including 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 country within the Parties will employ Territory for a Product compared to [***], Coherus shall have the right to terminate all rights granted to Distributor under this Agreement with respect to such Product in such country, and 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 Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsomitted portions.

Pharmacovigilance. Within No later than [***] after the Effective Dateprior to (a) [***] or (b) [***], the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes 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. Landos 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 will also provide for a worldwide safety database to be maintained by Landos Lyra at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees Sublicensees, and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement Agreement, and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] after the Effective DateOrexigen and Takeda entered into a pharmacovigilance agreement effective as of September 10, 2014 (as may be amended by the Parties will negotiate in good faith and finalize the actions that the Parties will employ accordance with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (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 ICH guidelines. These responsibilities will include mutually acceptable guidelines and procedures Takeda shall be responsible, at its own expense, for the receipt, investigation, recordation, communicationestablishment and maintenance of the global safety database for Products in all Indications in the Territory. Each Party shall cooperate (at its sole cost and expense), and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Productshall cause its Affiliates, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance withlicensees, and enable the Parties sublicensees 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 requirementscooperate, in which case local reporting requirement will prevailimplementing a pharmacovigilance mutual alert process with respect to the Products and to comply with all applicable Laws. Lian will Generally, (a) prior to transfer of the Regulatory Filings as set forth in Section 3.4.2, Orexigen shall be responsible for reporting quality complaints, Adverse Eventssubmitting all required IND safety reports contemplated by 21 C.F.R. 312.32, and safety data related 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 Licensed Products in the Field to applicable appropriate Regulatory Authorities in the Territory, in accordance with applicable Laws; (b) following transfer of the Regulatory Filings as well as responding set forth in Section 3.4.2, and with respect to safety issues and any other Regulatory Filings, Takeda shall be responsible for reporting all adverse drug reaction experiences required to all requests of 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 Licensed Products and required to be reported to the appropriate regulatory authorities outside of the Territory, in accordance with the Field 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. Landos will be responsible for reporting quality complaints, Adverse Events, The JSC shall review from time to time Takeda’s and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues Orexigen’s pharmacovigilance policies and to all requests of Regulatory Authorities relating to Licensed Product outside the Territoryprocedures. The Pharmacovigilance Agreement will also provide for a worldwide safety database identifies the responsibilities of each Party regarding the information to be maintained by Landos at its sole cost exchanged and expensethe timeframes for such exchange, which worldwide safety database will be accessible by Lian regulatory reporting, literature review, risk management, 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationslabeling.

Pharmacovigilance. Within No later than [***] after days following the Effective Date, but in any event [***], the Parties will negotiate in good faith and finalize shall enter into a pharmacovigilance agreement setting forth the actions that worldwide pharmacovigilance procedures for the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities , which agreement will include mutually acceptable guidelines provide for coordination and procedures for sharing of relevant safety information related to the receipt, investigation, recordation, communication, and exchange (as Licensed Products between the Parties) Parties in order to facilitate prompt filing of Adverse Event accurate and consistent 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 to Regulatory Authorities in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable compliance with 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 Each Party shall hold the primary responsibility for reporting quality complaints, Adverse Events, adverse events and other safety data related to the Licensed Products in its territory to the Field to applicable Regulatory Authorities in the Territoryits territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating in its territory related to the Licensed Products, in each case, at its own cost and to the extent required by Applicable Laws. ReViral shall be responsible for the establishment and maintenance of a global safety database at its own cost and expense. Licensee may, at its own cost and expense, establish and maintain its own local safety database to store the safety information generated from the Development of the Licensed Products in the Field Territory, and to assure regulatory reporting compliance in the Territory. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will agrees to comply with its respective obligations under such the Pharmacovigilance Agreement and will to cause its Affiliates Affiliates, licensees and Sublicensees and contractors to comply with such obligations. Each Party will notify the other Party of any new planned Clinical Trials for any Licensed Product and the Parties will update the Pharmacovigilance Agreement to the extent necessary to comply with any applicable requirements set forth under Applicable Law or of any Regulatory Authorities related to adverse event reporting, drug safety, patient safety, pharmacovigilance, and risk management. Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, each Party and its Affiliates, licensees, and Sublicensees will have the right to disclose information related to the safety of the Compounds or Licensed Products to the extent that such disclosure is required for such Party to comply with its obligations under Applicable Law or the safety requirements of the applicable Regulatory Authorities. To the extent that there is a conflict between the terms of this Agreement and the terms of the Pharmacovigilance Agreement, the terms of the Pharmacovigilance Agreement will govern with respect to the subject matter set forth therein.

Pharmacovigilance. Within [***] after 7.6.1 On a Collaboration Target-by-Collaboration Target basis, prior to the Effective DateInitiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, the Parties will negotiate in good faith and finalize enter into a pharmacovigilance agreement setting forth the actions that worldwide pharmacovigilance procedures for the Parties will employ with respect to the Licensed Products, such as safety data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement Directed Against such Collaboration Target (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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 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 Each Party will be responsible for reporting quality complaints, Adverse Events, adverse events and safety data related to the Licensed Products in to the Field to applicable Regulatory Authorities in the Territoryits territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating related to the Licensed Products in the Field its territory, in the Territoryeach case at its own cost. Landos The initial global safety database will be responsible for reporting quality complaints, Adverse Eventsestablished by Kymera using its Approved Third Party Contractors, and safety data related to Licensed Product to applicable Regulatory Authorities outside the TerritoryKymera will, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its ▇▇▇▇▇▇’s sole cost and expense, which worldwide transfer such global safety database to Sanofi upon Sanofi’s written request reasonably in advance of the desired transfer date, which transfer date will be accessible no later than [***] and in the form requested by Lian Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Products prior to Sanofi’s assumption and its Affiliates, Sublicensees and contractors to implementation of the full extent necessary for Lian to exercise its rights under this global safety database in accordance with the Pharmacovigilance Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will agrees to comply with its respective obligations under such the Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to [***] comply with such obligations. Among other things, the Pharmacovigilance Agreement will provide the right for each Party to cross-reference all relevant safety data of the other Party. 7.6.2 Without limiting the foregoing, (a) if a Material Safety Event occurs during the Sanofi Participation Term, and [***], Sanofi will provide written notice thereof to Kymera (a “Sanofi Material Safety Event Notice”) and (b) if a Party, in accordance with such Party’s internal operating procedures consistently applied across its own pharmaceutical products, determines that a Material Safety Event has occurred with respect to a Clinical Trial

Pharmacovigilance. Within [***] after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos Licensor 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 will also provide for a worldwide safety database to be maintained by Landos Licensor at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within (a) The Parties will enter into a pharmacovigilance agreement within [***] after the License Agreement Effective Date, the Parties will negotiate in good faith and finalize the actions Date that the Parties will employ 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 to protect patients and promote their well-being in a written pharmacovigilance agreement each Party’s territory (the “Pharmacovigilance Agreement”). These responsibilities In general, the Pharmacovigilance Agreement will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange provide that (as between the Partiesi) 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 Eventssuch obligations within the ROW Territory, and [***] will be responsible for such obligations outside the ROW Territory. [***] will deploy and administer any safety data related to monitoring activity implemented for the Licensed Candidates and Licensed Products in the Field to applicable Regulatory Authorities ROW Territory, and be responsible for all pharmacovigilance activities 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 outside the ROW Territory, and (iii) [***] will establish and maintain a global safety database for Licensed Candidates and Licensed Products that will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each Party pursuant to the Pharmacovigilance Agreement, including information and data arising out of any safety monitoring activities. (b) The Parties shall discuss, through the JRDC, 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 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 such Licensed Candidate or Licensed Product. Each Party shall have the right to take [***], including the right to [***] of such Licensed Candidate or Licensed Product, if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***]. (d) In 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 (iii) timely provide the other Party with [***] such Licensed Candidate or Licensed Product of which the [***], as far as this relates to [***] to perform their obligations or exercise their rights under this License Agreement. Treatment of safety information, standard operating procedures and training, as well as responding to safety issues and to all requests a statement of Regulatory Authorities relating to Licensed Products respective regulatory obligations shall be agreed in the Field in the Territory. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] after 7.6.1 On a Collaboration Target-by-Collaboration Target basis, prior to the Effective DateInitiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, the Parties will negotiate in good faith and finalize enter into a pharmacovigilance agreement setting forth the actions that worldwide pharmacovigilance procedures for the Parties will employ with respect to the Licensed Products, such as safety data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement Directed Against such Collaboration Target (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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 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 Each Party will be responsible for reporting quality complaints, Adverse Events, adverse events and safety data related to the Licensed Products in to the Field to applicable Regulatory Authorities in the Territoryits territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating related to the Licensed Products in the Field its territory, in the Territoryeach case at its own cost. Landos The initial global safety database will be responsible for reporting quality complaints, Adverse Eventsestablished by Kymera using its Approved Third Party Contractors, and safety data related to Licensed Product to applicable Regulatory Authorities outside the TerritoryKymera will, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its ▇▇▇▇▇▇’s sole cost and expense, which worldwide transfer such global safety database to Sanofi upon Sanofi’s written request reasonably in advance of the desired transfer date, which transfer date will be accessible no later than [***] and in the form requested by Lian Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Products prior to Sanofi’s assumption and its Affiliates, Sublicensees and contractors to implementation of the full extent necessary for Lian to exercise its rights under this global safety database in accordance with the Pharmacovigilance Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will agrees to comply with its respective obligations under such the Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to [***] comply with such obligations. Among other things, the Pharmacovigilance Agreement will provide the right for each Party to cross-reference all relevant safety data of the other Party. 7.6.2 Without limiting the foregoing, (a) if a Material Safety Event occurs during the Sanofi Participation Term, and [***], Sanofi will provide written notice thereof to Kymera (a “Sanofi Material Safety Event Notice”) and (b) if a Party, in accordance with such Party’s internal operating procedures consistently applied across its own pharmaceutical products, determines that a Material Safety Event has occurred with respect to a Clinical Trial conducted by or on behalf of Kymera under this Agreement, such Party will provide written notice thereof to the other Party (a “Kymera Material Safety Event Notice”). Any such notice issued by a Party under this Section 7.6.2 will include [***].

Pharmacovigilance. Within [***] after the Effective Date], the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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 LawLaws. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian Licensee will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to the Licensed Products Product 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. Landos Company will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to Licensed Product to applicable Regulatory Authorities outside the TerritoryTerritory or outside the Field, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the TerritoryTerritory or outside the Field. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos Company at its sole cost and expense, which worldwide safety database will be accessible by Lian and Licensee, its Affiliates, Sublicensees and contractors to the full extent necessary for Lian Licensee to exercise its rights under this Agreement, comply with its obligations under this Agreement Agreement, and comply with all applicable LawLaws. Each Party will hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and will to cause its Affiliates Affiliates, Affiliated Entities (to the extent applicable) and Sublicensees permitted sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [Syndax shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Product. Syndax (or its designee) shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product in the countries outside the Territory as well as, to the ***] after * 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 communicating to Regulatory Authorities outside the Effective Date, the Parties will negotiate Territory. KHK shall reasonably cooperate with and assist Syndax upon request as required by Syndax in good faith and finalize the actions that the Parties will employ order to comply with Syndax’s regulatory obligations with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (Product outside of the “Pharmacovigilance Agreement”)Territory. These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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 KHK shall be responsible for reporting quality complaintsthe collection, Adverse Eventsreview, assessment, tracking and safety data filing of information related to adverse events associated with 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 Product in the Field in the Territory. Landos will be responsible for Not later than the date of the first IND submission in the Territory or such earlier date required by Applicable Law with respect to the Parties’ activities hereunder, the Parties shall enter into a separate, written pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting quality complaintsand monitoring of all adverse events, Adverse Events, risk management activities and other relevant drug safety data related matters with respect to Licensed Product to applicable Regulatory Authorities outside Products during the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the TerritoryTerm. The Pharmacovigilance PV Agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian permit each Party (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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors designees or licensees) to comply with such obligationsApplicable Law and regulatory requirements in their respective markets.

Pharmacovigilance. Within [***] 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) 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 will negotiate in good faith shall amend and finalize restate the actions that PV Agreement to address the Parties will employ exchange of safety information with respect to the Licensed Products Product in the Territory (including with respect to protect patients Arena’s current and promote their wellfuture ex-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”Territory Distributors). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as As 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 Party holding 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 IND will be responsible for all safety reporting quality complaints, Adverse Events, and safety data related for clinical development (unless otherwise agreed to by the Licensed Products Parties) in the Field to applicable Regulatory Authorities in the Territory, as well as responding to Territory and will assume all such expenses associated with safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field reporting in the Territory. Landos Eisai (or its designated Affiliate or Sub-distributor) will be responsible for all safety 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 Commercialization of the Product outside in the Territory and will assume all such expenses associated with safety reporting in the Territory. The Pharmacovigilance Agreement will also provide Eisai shall be responsible for a worldwide safety database ensuring compliance by its Affiliates or Sub-distributors with respect to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to pharmacovilgilance responsibilities under the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this PV Agreement and comply Applicable Law in the applicable countries in the Territory. Arena shall be responsible for ensuring compliance by Arena ex-Territory Distributors with all applicable Lawrespect to pharmacovigilance responsibilities under the PV Agreement and Applicable Law in the ex-Territory countries, including safety reporting requirements. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement shall cooperate and will shall cause its Affiliates (and, in the case of Arena, shall cause the Arena ex-Territory Distributors, and Sublicensees in the case of Eisai, shall cause the Sub-distributors) to cooperate in implementing a pharmacovigilance mutual alert process with respect to the Products. Arena and contractors Eisai shall each have the right to comply subcontract any such activities to a Third Party. Further, the PV Agreement shall provide: (a) a Joint Product Safety Committee (the “JPSC”) will be established by the Parties as a JDC Subcommittee with representatives from Eisai and Arena (including pharmacovigilance, regulatory, medical affairs and legal representatives); (b) the JPSC shall seek to act by consensus whenever possible, with Eisai representatives having final decision-making authority; (c) Arena shall have the 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 submitted to ex-Territory countries provide Arena a reasonable amount of time to review and comment on such obligations.reports (and the Parties shall seek to reach conclusions by consensus, with Eisai having final decision-

Pharmacovigilance. Within (a) The Parties will enter into a pharmacovigilance agreement within [***] after the License Agreement Effective Date, the Parties will negotiate in good faith and finalize the actions Date that the Parties will employ 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 to protect patients and promote their well-being in a written pharmacovigilance agreement each Party’s territory (the “Pharmacovigilance Agreement”). These responsibilities In general, the Pharmacovigilance Agreement will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange provide that (as between the Partiesi) 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 Eventssuch obligations within the ROW Territory, and [***] will be responsible for such obligations outside the ROW Territory. [***] will deploy and administer any safety data related to monitoring activity implemented for the Licensed Candidates and Licensed Products in the Field to applicable Regulatory Authorities ROW Territory, and be responsible for all pharmacovigilance activities 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 outside the ROW Territory, and (iii) [***] will establish and maintain a global safety database for Licensed Candidates and Licensed Products that will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each Party pursuant to the Pharmacovigilance Agreement, including information and data arising out of any safety monitoring activities. (b) The Parties shall discuss, through the JRDC, 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 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 such Licensed Candidate or Licensed Product. Each Party shall have the right to take [***], including the right to [***] of such Licensed Candidate or Licensed Product, if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***]. (d) In 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 (iii) timely provide the other Party with [***] such Licensed Candidate or Licensed Product of which the [***], as far as this relates to [***] to perform their obligations or exercise their rights under this License Agreement. Treatment of safety information, standard operating procedures and training, as well as responding to safety issues and to all requests a statement of Regulatory Authorities relating to Licensed Products respective regulatory obligations shall be agreed in the Field Pharmacovigilance Agreement. [***] Certain information in this document has been omitted and filed separately with the TerritorySecurities and Exchange Commission. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors Confidential treatment has been requested with respect 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsomitted portions.

Pharmacovigilance. Within [***] after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect Subject to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receiptterms of this Section 5.6.1, investigation, recordation, communication, and exchange (as 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 each Party shall 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 Territoryits respective pharmacovigilance obligations under Applicable Laws. Licensee, as well as responding to safety issues and to all requests the intended beneficiary under this Agreement of the privileges of ownership of the Regulatory Authorities relating to Licensed Products Approvals in the Field in the Territory. Landos will , shall be responsible for reporting quality complaintsthe collection, Adverse Eventsreview, assessment, tracking and safety data filing of information related to Licensed 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 Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Laws, including, for clarity, laws relating to applicable Regulatory Authorities outside adverse event reporting in the Territory). VBL (or its designee) shall be responsible for the collection, as well as responding review, assessment, tracking and filing of information related to safety issues and to all requests of Regulatory Authorities relating to Licensed adverse events associated with the Product in the countries outside the Territory. The Pharmacovigilance Agreement safety units from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information relating to the Product 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 Product and other safety information is exchanged according to a schedule that will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian permit each Party (and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise designees or its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors sublicensees) to comply with such obligationsApplicable Laws and regulatory requirements in their respective markets. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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.

Pharmacovigilance. Newsoara and its Affiliates shall be responsible for submitting all 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 Territory and requirements of Regulatory Authorities in the Territory. Newsoara and its Affiliates shall be responsible for reporting all adverse drug reaction experiences required to be reported to the appropriate Regulatory Authorities in the Territory in which the Product is being Developed for the Initial Indication or any Additional 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 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 any post-marketing reports of adverse drug experiences, relating to the Product required to be reported to the appropriate Regulatory Authorities outside of the Territory in accordance with the Applicable Laws and Guidelines of the relevant countries outside the Territory. LBS shall have the right to share any and all information received from Newsoara under this Section 7.3 or under Section 7.4 or Section 7.5 and/or any pharmacovigilance agreement between the Parties with LBS’s Affiliates, licensees and sublicensees outside the Territory. Within [***] a reasonable period after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in enter into a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as 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. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationson customary terms.

Pharmacovigilance. Within As soon as possible, but no later than [***] after ], 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 ICH guidelines. Takeda shall be responsible, at its own expense, for the Effective Date, *** Certain information on this page has been omitted and filed separately with the Parties will negotiate in good faith and finalize the actions that the Parties will employ Commission. Confidential treatment has been requested with respect to the Licensed Products to protect patients omitted portions. establishment and promote their well-being in a written pharmacovigilance agreement (maintenance of the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures global safety database for the receipt, investigation, recordation, communication, and exchange (as 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 Indications in the Territory. Landos 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 will also provide for a worldwide safety database to be maintained by Landos Each Party shall cooperate (at its sole cost and expense), which worldwide safety database will be accessible by Lian and shall cause its Affiliates, Sublicensees licensees and contractors sublicensees to cooperate, in implementing a pharmacovigilance mutual alert process with respect to the full extent necessary for Lian Products and to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable LawLaws. Each Party will comply 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 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 respective obligations 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 and will cause its pharmacovigilance agreement with Takeda’s Affiliates and Sublicensees in the Territory. The JSC shall review from time to time Takeda’s and contractors Orexigen’s pharmacovigilance policies and procedures. The pharmacovigilance agreement shall identify the responsibilities of each Party regarding the information to comply with be exchanged and the timeframes for such obligationsexchange, regulatory reporting, literature review, risk management, and labeling.

Pharmacovigilance. Within [***] after the Effective Date, the Parties Company and Licensee will negotiate in good faith and finalize the actions that the Parties Company and Licensee will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the PartiesCompany and Licensee) 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 Company and Licensee to fulfill, local and national regulatory reporting obligations under applicable LawLaws. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian Licensee will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to the Licensed Products Product 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; provided that Licensee will conduct such activities (1) in its own name, if Licensee is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Field in the Territory or (2) as the express and authorized regulatory agent of record for Company in the Field in the Territory, if Company is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Territory, under which situation such actions will be taken on behalf of Company and for the benefit of Licensee in the Field in the Territory. Landos Company will be responsible for reporting quality complaints, Adverse Events, Events and safety 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 Landos Company at its sole cost and expense, to which Licensee shall contribute data in such form and format, and on such other terms, as provided in the Pharmacovigilance Agreement and which worldwide safety database will be accessible by Lian and Licensee, its Affiliates, Sublicensees and contractors to the full extent necessary for Lian Licensee to exercise its rights under this Agreement, comply with its obligations under this Agreement Agreement, and comply with all applicable LawLaws. Each Party will of Company and Licensee hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and will to cause its Affiliates and Sublicensees its and their sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] after Subject to the Effective Dateterms of this Agreement, NovaDel and BioAlliance (under the Parties will negotiate in good faith guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that responsibilities the Parties will parties shall employ with respect to the Licensed Products to protect patients who receive Licensed Product and promote their well-being in a written pharmacovigilance agreement separate Safety Data Exchange Agreement (the “Pharmacovigilance AgreementSDEA”), and NovaDel will use Commercially Reasonable Efforts to have its other licensees of Licensed Product agree to be parties to the SDEA. These responsibilities will shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, communication and exchange (as between the Partiesparties) of safety information such as Adverse Event reports Events, pregnancy exposure, lack of efficacy, misuse/abuse; and any other information concerning the safety of any the Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties parties to fulfill, local and national international regulatory reporting obligations under applicable Lawto Regulatory Authorities. Furthermore, such agreed procedure will procedures shall be consistent with relevant ICH FDA and International Council for Harmonization (ICH) guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will requirements shall prevail. Lian will The SDEA shall provide that: (i) BioAlliance shall be responsible for reporting quality complaints, Adverse Events, and safety data related to all pharmacovigilance activities regarding the Licensed Products in the Field to applicable Regulatory Authorities Product in the Territory, as well as responding including signal detection, medical surveillance, risk management, global medical literature review and monitoring, Adverse Event reporting and responses to safety issues and to all regulatory authority requests of Regulatory Authorities relating to Licensed Products or enquiries; (ii) in the Field event NovaDel receives safety information regarding the Licensed Product, or information regarding any safety-related regulatory request or inquiry, NovaDel shall notify BioAlliance as soon as practicable, but, in any event, not later than five (5) business days after it receives such safety information, regulatory authority request or query; and (iii) in the Territory. Landos will be responsible for reporting quality complaintsevent BioAlliance receives safety information regarding the Licensed Product, Adverse Eventsor information regarding any safety-related regulatory request or inquiry, and BioAlliance shall notify NovaDel as soon as practicable, but, in any event, not later than five (5) business days after it receives such safety data related to Licensed Product to applicable Regulatory Authorities outside the Territoryinformation, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsregulatory authority request or query.

Pharmacovigilance. Within [***] Subject to the terms of this Agreement, as needed, within three (3) months after the Effective Execution Date, or notification to the Pharmacovigilance Departments of the execution date, the Parties will negotiate in good faith (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the actions that responsibilities the Parties will shall employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (connection with the “Pharmacovigilance Agreement”)use of the Licensed Compound or Licensed Product. These responsibilities will shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound or Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and national international regulatory reporting obligations under applicable Lawto government authorities. Furthermore, such agreed procedure will procedures shall be consistent with relevant ICH International Council for Harmonization (ICH) guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will requirements shall prevail. Lian will be Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the party responsible for Pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound or Licensed Product subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting quality complaints, Adverse Eventsobligations are fulfilled. Any regulatory commitments relating to BMS’ prior development activities regarding the Licensed program in the Partner Territory prior to the Effective Date will remain the responsibility of BMS, and safety promptly after the Effective Date, BMS shall provide ZAI with pharmacovigilance data related that is set forth in the Pharmacovigilance Agreement for the Licensed Product(s) obtained prior to the Licensed Products Effective Date. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Field Securities and Exchange Commission pursuant to applicable Regulatory Authorities in Rule 406 of the TerritorySecurities Act of 1933, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos 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 will also provide for a worldwide safety database to be maintained by Landos at its sole cost and 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 will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsamended.