Common use of Pharmacovigilance Agreement Clause in Contracts

Pharmacovigilance Agreement. Within [**] after the Effective Date, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will define and finalize the Parties’ responsibilities with respect to pharmacovigilance activities in a written Pharmacovigilance Agreement. Such Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange by the Parties of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines and procedures will be in accordance with, and will enable each Party and its Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time) and to cause its Affiliates and licensees and permitted sublicensees (as applicable) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees (as applicable) will have the right to disclose Safety Data if such disclosure is reasonably necessary to comply with Applicable Laws and regulations and requirements of Regulatory Authorities within the Territory (or outside of the Territory with respect to Akebia) with respect to its filings and activities related to the Licensed Product.

Pharmacovigilance Agreement. Within [**] after At least twelve (12) months (or such other time period agreed by the Effective DateParties) in advance of any Regulatory Approval in any country in the Otsuka Territory, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will define enter into a written pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for and finalize responsibilities of the Parties’ responsibilities Parties with respect to pharmacovigilance activities in a written the Compound and Products, such as Safety Data sharing, adverse events reporting and safety signal and risk management (the “Pharmacovigilance Agreement”), which agreement shall be amended by the Parties from time to time as necessary to comply with any changes in Applicable Laws or guidance received from Regulatory Authorities. Such Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange by the Parties of information that a Party becomes aware of in the Otsuka Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of nonNon-clinical studiesClinical Studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Productand other Safety Data, including any such information and other Safety Data received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines All procedures and procedures will responsibilities set forth in the Pharmacovigilance Agreement shall be in accordance with, and will enable each Party and its Affiliates the Parties to fulfill, local local, national and international regulatory reporting obligations under Applicable Laws (including to Regulatory Authoritiesthe extent applicable, obligations contained in ICH guidelines). Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time to time) and to cause its Affiliates and licensees and permitted sublicensees Sublicensees (as applicable) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees and licensees and Sublicensees (as applicable) will have the right to disclose Safety Data if such disclosure is reasonably necessary to comply with Applicable Laws and Regulatory Authority regulations and requirements of Regulatory Authorities within in its Territory. After the Territory (or outside execution of the Territory Pharmacovigilance Agreement, the Parties’ sole obligations with respect to Akebia) pharmacovigilance procedures for and responsibilities with respect to its filings the Compound and activities related Products, such as Safety Data sharing, adverse events reporting and safety signal and risk management, shall be as set out in the Pharmacovigilance Agreement. Once executed, the Pharmacovigilance Agreement shall supersede and replace the terms of this Agreement applicable to pharmacovigilance, all as may be further described in the Licensed ProductPharmacovigilance Agreement.

Pharmacovigilance Agreement. Within [***] after of the License Effective Date, the Parties (under the guidance but in any event prior to commencement of their respective pharmacovigilance departments, or equivalent thereof) will define and finalize the Parties’ responsibilities any clinical trials with respect to pharmacovigilance activities the Licensed Product in the Territory, the Parties will in good faith negotiate and finalize a written safety data exchange agreement (the “Pharmacovigilance Agreement. Such Pharmacovigilance Agreement will provide ”), the terms of which shall set forth the guidelines, obligations, procedures and timelines for the receipt, investigation, recording, communication, and exchange by (as between the Parties Parties) of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research patient or subject orAdverse Event reports, in the case of non-clinical studies, an animal in a toxicology studypregnancy reports, and any other information concerning the seriousness thereof, whether safety of the Licensed Product or not determined to be attributable to observed in [***] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED] connection with the Licensed Product, including any such information received by either and other routine pharmacovigilance reporting requirements, in order to enable the other Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines and procedures will be in accordance with, and will enable each Party and comply with its Affiliates to fulfill, local and international regulatory safety reporting obligations to the applicable Regulatory AuthoritiesAuthorities and to protect patients and promote their well-being. Subject The Pharmacovigilance Agreement shall include terms governing each Party’s responsibility for preparing Adverse Event reports and responses to compliance safety issues and requests of Regulatory Authorities relating to Licensed Products, for filing such reports and responses with Applicable LawRegulatory Authorities in the Territory, each and for reporting any quality complaints, Adverse Events and safety data related to Licensed Products in the Territory for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under the such Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time) and to cause its Affiliates and permitted Sublicensees or licensees and permitted sublicensees (as applicable) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees (as applicable) will have the right to disclose Safety Data if such disclosure is reasonably necessary to comply with Applicable Laws and regulations and requirements of Regulatory Authorities within the Territory (or outside of the Territory with respect to Akebia) with respect to its filings and activities related to the Licensed Product.

Pharmacovigilance Agreement. Within [**] after At least one (1) month (or such other time period agreed by the Effective DateParties) in advance of any Regulatory Approval in any country in the Territory, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will define enter into a written pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for and finalize responsibilities of the Parties’ responsibilities Parties with respect to pharmacovigilance activities in a written the Compound and Products, such as safety data sharing, adverse events reporting and safety signal and risk management (the “Pharmacovigilance Agreement”), which agreement shall be amended by the Parties from time to time as necessary to comply with any changes in Applicable Laws or guidance received from Regulatory Authorities. Such Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange by the Parties of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Productand other safety data, including any such information and other safety data received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines All procedures and procedures will responsibilities set forth in the Pharmacovigilance Agreement shall be in accordance with, and will enable each Party and its Affiliates the Parties to fulfill, local local, national and international regulatory reporting obligations under Applicable Laws (including to Regulatory Authoritiesthe extent applicable, obligations contained in ICH guidelines). Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time to time) and to cause its Affiliates and licensees and permitted sublicensees Sublicensees (as applicable) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees and licensees and Sublicensees (as applicable) will have the right to disclose Safety Data safety data if such disclosure is reasonably necessary to comply with Applicable Laws and Regulatory Authority regulations and requirements in its respective territory. To the extent there is any inconsistency between the terms of Regulatory Authorities within the Pharmacovigilance Agreement, once executed, and the terms of this Agreement, the terms of the Pharmacovigilance Agreement shall govern. (b) The Pharmacovigilance Agreement will include provisions regarding the establishment of a global safety database for the Products that will be owned and maintained by Santhera at its sole cost and expense. Santhera will ensure that each Party, its Affiliates, licensees and Sublicensees are able to access the data, if necessary indirectly, from the global safety database in order to meet legal and regulatory obligations. Santhera shall be responsible, at its cost and expense, for (a) pharmacovigilance with respect to the Products outside the Territory (or outside of and in the Territory until the NDA Transfer Date) and (b) for the collection, assessment, and safety reporting of individual case safety reports to Regulatory Authorities, and generating aggregated report(s), risk management plan and responses to any requests from Regulatory Authorities, with respect to Akebia) Products outside the Territory (and in the Territory until the NDA Transfer Date), and for sharing such information with respect Catalyst for its compliance with regulatory requirements in the Territory, in each case subject to its filings and activities related to in compliance with Applicable Law and the Licensed ProductPharmacovigilance Agreement.

Pharmacovigilance Agreement. Within No later than [***] after prior to the Effective Datefirst anticipated Regulatory Approval of a Licensed Product in the Territory (or earlier if Licensee conducts any Development activities in the Territory with respect to the Licensed Product), the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will shall define and finalize the Parties’ responsibilities with respect to pharmacovigilance activities in a written Pharmacovigilance Agreement. Such Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange by the Parties of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Compound or any Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines and procedures will shall be in accordance with, and will shall enable each Party and its Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time) and to cause its Affiliates and licensees and permitted sublicensees (as applicablewith respect to Akebia) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees (as applicablewith respect to Akebia) will have the right to disclose Safety Data if such disclosure is reasonably necessary to comply with Applicable Laws and regulations and requirements of Regulatory Authorities within the Territory (or outside of the Territory with respect to Akebia) with respect to its filings and activities related to the Licensed ProductCompound and the Licensed Products.

Pharmacovigilance Agreement. Within At least [**] after the Effective Date*], the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will define enter into a written pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for and finalize responsibilities of the Parties’ responsibilities Parties with respect to pharmacovigilance activities in a written the API and Products, such as, but not limited to, safety data sharing, adverse events reporting and safety signal and risk management (the “Pharmacovigilance Agreement”). Such The Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange may be amended by the Parties of information that a Party becomes aware of from time to time as necessary to comply with any changes in Applicable Laws or guidance received from any Regulatory Authority. All procedures and responsibilities set forth in the Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines and procedures will Pharmacovigilance Agreement shall be in accordance with, and will enable each Party and its Affiliates the Parties to fulfill, local local, national and international regulatory reporting obligations under Applicable Laws (including to Regulatory Authoritiesthe extent applicable, obligations contained in ICH guidelines). Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (or its equivalent), as the Parties may agree to modify it from time to time-to-time) , and to cause its Affiliates and licensees and permitted sublicensees (as applicable) Sublicensees to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees and licensees and Sublicensees (as applicable) will have the right to disclose Safety Data safety data if such disclosure is reasonably necessary to comply with Applicable Laws and Regulatory Authority regulations and requirements in its Territory. Once executed, the Pharmacovigilance Agreement shall supersede and replace the terms of Regulatory Authorities within this Agreement applicable to pharmacovigilance. The language of all communications and exchanges under the Territory Pharmacovigilance Agreement (or outside of the Territory with respect to Akebiaits equivalent) with respect to its filings and activities related to the Licensed Productshall be English.