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. (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 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. 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. Subject to the terms of this Agreement, as needed, within three (a3) Each Party months after the Execution Date, or notification to the Pharmacovigilance Departments of the execution date, the Parties (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound or Licensed Product. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound or Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. 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 all pharmacovigilance activities associated with the Licensed Product in its respective territory, including filing all reports required Pharmacovigilance prior to be filed in order to maintain any IND execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound or Licensed Product filed by or under subject to all applicable regulations and guidelines. In the authority of such Partyevent that this Agreement is terminated, and/or the Parties agree to implement the necessary procedures and practices to ensure that any Regulatory Approvals granted for outstanding pharmacovigilance reporting obligations are fulfilled. Any regulatory commitments relating to BMS’ prior development activities regarding the Licensed Product, program in its territory (including reporting of adverse drug experiences, product quality complaints and safety data relating the Partner Territory prior to the Licensed Product in its territory). Each Party shall Effective Date will remain the responsibility of BMS, and 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 after the Effective Date, BMS shall provide ZAI with pharmacovigilance data that is set forth in the Pharmacovigilance Agreement for the Licensed Product(s) obtained prior to the Effective Date. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the precise timing Securities and Exchange Commission pursuant to be mutually agreed upon by Rule 406 of the PartiesSecurities Act of 1933, 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: [***]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. Subject to the terms of this Agreement, NovaDel and BioAlliance (aunder the guidance of their respective pharmacovigilance departments, or equivalent thereof) Each Party shall define and finalize the responsibilities the parties shall employ to protect patients who receive Licensed Product and promote their well-being in a separate Safety Data Exchange Agreement (“SDEA”), and NovaDel will use Commercially Reasonable Efforts to have its other licensees of Licensed Product agree to be parties to the SDEA. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication and exchange (as between the parties) of safety information such as Adverse Events, pregnancy exposure, lack of efficacy, misuse/abuse; and any other information concerning the safety of the Licensed Product. Such guidelines and procedures will be in accordance with, and enable the parties to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Furthermore, such agreed procedures shall be consistent with relevant FDA and International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The SDEA shall provide that: (i) BioAlliance shall be responsible for all pharmacovigilance activities associated with regarding the Licensed Product in its respective territorythe Territory, including filing all reports required signal detection, medical surveillance, risk management, global medical literature review and monitoring, Adverse Event reporting and responses to be filed regulatory authority requests or enquiries; (ii) 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 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 its territory any event, not later than five (including reporting of adverse drug experiences5) business days after it receives such safety information, product quality complaints regulatory authority request or query; and (iii) in the event BioAlliance receives 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 information regarding the Licensed Product, or information regarding any safety-related regulatory request or inquiry, BioAlliance shall notify NovaDel as soon as practicable, but, in any country within its territory. Each Party shall ensure that its Affiliates and licensees event, not later than five (and5) business days after it receives such safety information, 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 basisauthority request or query. (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. (a) Each Party shall be responsible for all pharmacovigilance activities associated with the Licensed Product in its respective territory7.6.1 On a Collaboration Target-by-Collaboration Target basis, 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 prior 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 Initiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, and/or any Regulatory Approvals the Parties will enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures 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 Licensed Products, such as safety management data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products Directed Against such Collaboration Target (the “Pharmacovigilance Agreement”). Such procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party will be responsible for reporting quality complaints, adverse events and safety data related to the Licensed Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, in each case at its own cost. The initial global safety database will be established by Kymera using its Approved Third Party Contractors, and Kymera will, at Kymera’s sole cost and expense, 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 no later than [***] and in the form requested by Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Product on a Products prior to Sanofi’s assumption and implementation of the global basissafety database in accordance with the Pharmacovigilance Agreement. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to [***] 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. (b) Following 7.6.2 Without limiting the Effective Dateforegoing, with if a Material Safety Event occurs during the precise timing to be mutually agreed upon by the PartiesSanofi Participation Term, but in any event prior to and [***], the Parties shall enter into Sanofi will provide written notice to Kymera (a pharmacovigilance agreement on terms no less stringent than those required “Material Safety Event Notice”). Any such notice issued by applicable ICH Guidelines, including: Sanofi under this Section 7.6.2 will include [***]. (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) 11.4.1 Each Party shall strictly comply (at its sole cost and expense), and shall cause its Affiliates, licensees and Co-promotion Partners to strictly comply, in implementing a pharmacovigilance mutual alert process to comply with all applicable legal obligations of Regulatory Authorities with respect to the Product. Without limiting the generality of the above, Dara shall be responsible for all pharmacovigilance activities associated with implementing the Licensed Product procedures required by the Regulatory Authorities 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)Territory. Each Party shall promptly notify keep the other Party informed in a timely manner of all communications exchanged with respect to any material safety changes or material safety issues the Regulatory Authorities, so that each Party 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, its obligations 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 Regulatory Approval holder. 11.4.2 Subject to the core safety management for the Licensed Product on a global basis. terms of this Agreement, and within sixty (b60) Following days of the Effective Date, with Dara and Onxeo (under the precise timing to be mutually agreed upon by guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the Parties, but in any event prior to [***], procedures the Parties shall enter into employ to protect patients who receive the Product and promote their well-being in a pharmacovigilance agreement on terms no less stringent than those required by applicable ICH Guidelinesseparate Safety Data Exchange Agreement (“SDEA”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, including: [***]. investigation, recordation, communication and exchange (cas between the parties) Without limiting Sections 4.5(a) of safety information such as Adverse Drug Experiences, pregnancy exposure, lack of efficacy, misuse/abuse; and (b) above, within a reasonable period any other information concerning the safety of time following the Effective Date (with the precise timing to Product. Such guidelines and procedures will 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 Territoryaccordance with, and enable the parties to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Furthermore, such agreed procedures shall exchange any safety data timely as established be consistent with relevant laws and regulations in the pharmacovigilance agreement between the PartiesTerritory and International Council for Harmonisation (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The pharmacovigilance agreement “SDEA” shall include provisions to facilitate and ensure that each Party has sufficient information to maintain such a databaseform an integral part of this Agreement.

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. (a) Each Party Wyeth shall be solely responsible for all of the following in the Territory: adverse experience reports; literature review and associated reports; adverse experience follow-up reports; preparation and submission of all safety reports to the Regulatory Authorities as required; maintaining information regarding Compounds and Products for inclusion in the global safety database; all interactions with relevant Regulatory Authorities and investigators; periodic submissions; risk management; safety monitoring, signal detection and safety measures (e.g., clinical holds and restriction on distribution). ADLS shall be solely responsible for all of the following outside the Territory or in connection with its clinical studies: adverse experience reports; literature review and associated reports; adverse experience follow-up reports; preparation and submission of all safety reports to the Regulatory Authorities as required; maintaining information regarding Compounds and Products for inclusion in the global safety database; all interactions with relevant Regulatory Authorities and investigators; periodic submissions; risk management; safety monitoring, signal detection and safety measures (e.g., clinical holds and restriction on distribution). Notwithstanding the foregoing and until such time as a pharmacovigilance activities associated with agreement is executed as provided in Section 4.8.4, to the Licensed Product in its respective territoryextent either Party has or receives any information regarding any adverse experience which may be related to the use of the Compounds and Products, including filing all reports required the Parties shall promptly forward such information as follows: · Fatal or life-threatening serious adverse events/adverse drug reactions judged by either the investigator or sponsor 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 reasonably related to the Licensed Product in its territory). Each Party Compounds, Products or protocol shall promptly notify be transmitted to the other Party with respect to any material safety changes or material safety issues that may arise in connection with any IND for within two (2) calendar days from 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 date received by the Parties pursuant receiving Party. · All other serious adverse events/adverse drug reactions not fatal or life-threatening but judged by either the investigator or sponsor to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements with respect be reasonably related to the core safety management for the Licensed Product on a global basis. (b) Following the Effective DateCompounds, with the precise timing to be mutually agreed upon by the Parties, but in any event prior to Products or [***], 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) ] Confidential Treatment Requested Confidential portion omitted and (b) above, within a reasonable period of time following the Effective Date (filed separately with the precise timing Commission protocol shall be transmitted to be mutually agreed upon the other Party within five (5) calendar days from the date received by the Partiesreceiving Party. If to Wyeth: Facsimile: 000-000-0000 Overnight courier to: Global Safety Surveillance Epidemiology & Labeling Wyeth Research GSSEL Triage Unit Dock E 000 Xxxxxx Xxxx Xxxxxxxxxxxx, but in any event prior XX 00000 If to [***])ADLS: Facsimile: 000-000-0000 Overnight courier to: Advanced Life Sciences Holdings, each Party shall establish and thereafter maintain a safety database with respect to the Licensed Product in such Party’s TerritoryInc. 0000 Xxxxx Xxxx Xxxxxxxxx, 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.XX 00000 Attn: Director of Regulatory Affairs

Pharmacovigilance. 5.4.1 Within [*] after the Effective Date, the parties agree to negotiate in good faith and enter into a pharmacovigilance agreement (the “PV Agreement”), which shall include mutually acceptable procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experiences, pregnancy reports and any other information concerning the safety of the Product, sufficient to permit each party to comply with its regulatory and other legal obligations within the applicable timeframes, shall be in accordance with U.S., EU and ICH guidelines, and shall be consistent with the “Pharmacovigilance Agreement” (as such term is to be defined in the Mundipharma Agreement); provided, however, that at Cidara’s request, the parties shall cooperate in good faith with each other and with Mundipharma to make Melinta a party to the Pharmacovigilance Agreement in which case all references in this Agreement to the PV Agreement shall be deemed to refer to such “Pharmacovigilance Agreement.” The PV Agreement shall specify that each party shall be responsible for monitoring all clinical experiences with respect to Product in the course of Development activities of which such party is the regulatory sponsor. The parties’ respective responsibilities regarding the following shall also be set forth in the PV Agreement: (a) Each Party filing all required reports with respect thereto (including quality complaints, adverse events and safety data); and (b) responding to safety issues and to all associated requests of Regulatory Authorities relating to Product in the Territory; provided that Cidara shall be responsible for all pharmacovigilance activities associated with monitoring and reporting obligations in respect 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 Lead Indication Trials. Prior 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 PartyTransfer Date, 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 Cidara shall be responsible for core safety management of the Licensed Product on a global basis; costs it incurs in complying with its monitoring and Licensor shall cooperate with reporting obligations under the PV Agreement and assist Licensee, as provided in any pharmacovigilance agreement executed by the Parties pursuant reporting relevant information to Section 4.5(b) below, to enable Licensee to meet its regulatory reporting requirements Melinta with respect to the core safety management Current Product for the Licensed Lead Indications. Melinta shall be responsible for the costs it incurs in complying with its monitoring obligations under the PV Agreement and in reporting relevant information to Cidara with respect to the any other Product on a global basisor indications. Following the Transfer Date, Melinta shall be responsible for the costs it incurs in complying with its monitoring obligations under the PV Agreement and in reporting relevant information to Cidara with respect to the Current Product for the Lead Indications. 5.4.2 As between the parties, Cidara will hold, solely own and be solely responsible for maintaining the global safety database for Product, provisions concerning which (bincluding Xxxxxxx’s right to reference such database) shall be included in the PV Agreement. In addition, Cidara shall be responsible for the preparation and maintenance of the global developmental safety update reports, periodic safety update reports, risk management plans, signal detection activities, and the company core data sheet in respect of Product, subject to Melinta’s compliance with its monitoring obligations under the PV Agreement and its obligations thereunder to report relevant events to Cidara. Pursuant to the terms of the PV Agreement, Xxxxxxx will collaborate with Cidara in respect of signaling, aggregate reporting and labelling activities. Following the Effective Transfer Date, with Melinta shall be responsible for all associated safety reporting to FDA for 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: [***]Product. 5.4.3 Subject to the terms of the PV Agreement: (ca) Without limiting Sections 4.5(a) either party may audit relevant elements of the other party’s pharmacovigilance system to verify compliance with such party’s pharmacovigilance obligations; and (b) aboveif either party is subject to inspection of their pharmacovigilance system by a Regulatory Authority, within a reasonable period the parties will collaborate in preparing for inspection and addressing any inspection questions and findings, detail of time following the Effective Date (with the precise timing such collaboration 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 contained 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 databasePV Agreement.