Common use of Pharmacovigilance Agreement Clause in Contracts

Pharmacovigilance Agreement. Promptly following the Effective Date, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement no later than [**] days after the Effective Date. In the Pharmacovigilance Agreement, the Parties shall define how clinical safety and pharmacovigilance will be managed by both Parties, how the safety databases for the Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements of the Regulatory Authorities; (c) include provisions regarding producing outputs (tables, line listings) and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reports. At least [**] days before the estimated date of the first Regulatory Approval of the first Product in the Sobi Territory, the Parties shall commence discussions with respect to the amendment of such Pharmacovigilance Agreement to set forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first Regulatory Approval of the first Product in the Sobi Territory.

Pharmacovigilance Agreement. Promptly As soon as reasonably practicable following the Effective Datedesignation of a particular Development Candidate, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations and in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement any event no later than [***] days after prior to the Effective Date. In date on which Ionis or Biogen anticipates filing an IND for the Pharmacovigilance Agreementassociated Collaboration Product with a Regulatory Authority, the Parties shall define how clinical safety will enter into a Safety Drug Exchange Agreement relating to the collection, review, assessment, tracking, exchange and pharmacovigilance will be managed by both Parties, how filing of information related to adverse events associated with such Collaboration Product occurring prior to the safety databases for First Commercial Sale in any country on terms substantially the Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in same as the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements terms of the Regulatory Authorities; (c) include provisions regarding producing outputs (tablesSafety Drug Exchange Agreement to be entered into by the Parties with respect to adverse events associated with products developed under the Ionis/Biogen Additional Agreements. In addition, line listings) following the Amendment Date the Parties will discuss in good faith the possibility of entering into a single Safety Drug Exchange Agreement with respect to all activities under this Agreement and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reportsthe Ionis/Biogen Additional Agreements. At least No later than [***] days before prior the estimated date on which Biogen reasonably anticipates that it will exercise an Option, Biogen will so notify Ionis and the pharmacovigilance departments of each of Ionis and Biogen will meet and determine the first Regulatory Approval approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the first applicable Collaboration Product occurring after such First Commercial Sale, consistent with the provisions of this Section 5.2. Such approach will be documented in the Sobi Territory, a separate and appropriate written pharmacovigilance agreement between the Parties shall commence discussions which will control with respect to the amendment subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will specify that the owner of the IND for a Collaboration Product will be the global commercial safety database owner for such Collaboration Product with primary responsibility for maintaining such database, and that Ionis will be and remain the owner of the Ionis Internal ASO Safety Database with primary responsibility for maintaining such database. Such agreement will also specify that, prior to Biogen’s exercise of the applicable Option, the Parties will communicate updates on safety data regarding a Collaboration Product to Biogen through monthly telephone calls between the drug safety representatives of Biogen and Ionis. Biogen and Xxxxx will jointly review and discuss safety issues arising under any Collaboration Program that may have implications on any Initial Development Plan for such Collaboration Program. Biogen may suggest actions to address Collaboration Product safety data or audit findings, and Xxxxx will consider all such suggestions in good faith. The Pharmacovigilance Agreement to set forth the Parties’ respective obligations will be in detail regarding pharmacovigilance accordance with, and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and will enable the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first and their Affiliates or licensees or Sublicensees, as applicable, to fulfill, local and international regulatory reporting obligations to Regulatory Approval of the first Product in the Sobi TerritoryAuthorities and other Applicable Law.

Pharmacovigilance Agreement. Promptly As soon as reasonably practicable following the Effective Datedesignation of a particular Development Candidate, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations and in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement any event no later than [***] days after prior to the Effective Date. In date on which Isis anticipates filing an IND for the Pharmacovigilance Agreementassociated Collaboration Product with a Regulatory Authority, the Parties shall define how clinical safety will enter into a Safety Drug Exchange Agreement relating to the collection, review, assessment, tracking, exchange and pharmacovigilance will be managed by both Parties, how filing of information related to adverse events associated with such Collaboration Product occurring prior to the safety databases for First Commercial Sale in any country on terms substantially the Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in same as the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements terms of the Regulatory Authorities; (c) include provisions regarding producing outputs (tablesSafety Drug Exchange Agreement to be entered into by the Parties with respect to adverse events associated with products developed under the Isis/Biogen Idec Preexisting Development Agreements. In addition, line listings) following the Effective Date the Parties will discuss in good faith the possibility of entering into a single Safety Drug Exchange Agreement with respect to all activities under this Agreement and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reportsthe Isis/Biogen Idec Preexisting Development Agreements. At least No later than [***] days before prior the estimated date on which Biogen Idec reasonably anticipates that it will exercise an Option, Biogen Idec will so notify Isis and the pharmacovigilance departments of each of Isis and Biogen Idec will meet and determine the first Regulatory Approval approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the first applicable Collaboration Product occurring after such First Commercial Sale, consistent with the provisions of this Section 5.2. Such approach will be documented in the Sobi Territory, a separate and appropriate written pharmacovigilance agreement between the Parties shall commence discussions which will control with respect to the amendment subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will specify that the owner of the IND for a Collaboration Product will be the global commercial safety database owner for such Collaboration Product with primary responsibility for maintaining such database, and that Isis will be and remain the owner of the Isis Internal ASO Safety Database with primary responsibility for maintaining such database. Such agreement will also specify that, prior to Biogen Idec’s exercise of the applicable Option, the Parties will communicate updates on safety data regarding a Collaboration Product to Biogen Idec through monthly telephone calls between the drug safety representatives of Biogen Idec and Isis. Biogen Idec and Isis will jointly review and discuss safety issues arising under any Collaboration Program that may have implications on any Initial Development Plan for such Collaboration Program. Biogen Idec may suggest actions to address Collaboration Product safety data or audit findings, and Isis will consider all such suggestions in good faith. The Pharmacovigilance Agreement to set forth the Parties’ respective obligations will be in detail regarding pharmacovigilance accordance with, and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and will enable the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first and their Affiliates or licensees or Sublicensees, as applicable, to fulfill, local and international regulatory reporting obligations to Regulatory Approval of the first Product in the Sobi TerritoryAuthorities and other Applicable Law.

Pharmacovigilance Agreement. Promptly As soon as reasonably practicable following the Effective Datedesignation of a particular Development Candidate, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations and in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement any event no later than [***] days after prior to the Effective Date. In date on which Isis anticipates filing an IND for the Pharmacovigilance Agreementassociated Product with a Regulatory Authority, the Parties shall define how clinical safety will enter into a Safety Drug Exchange Agreement relating to the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with such Product occurring prior to the First Commercial Sale in any country on terms substantially the same as the terms of the Safety Drug Exchange Agreement to be entered into by the Parties with respect to adverse events associated with products developed under the Isis/Biogen Preexisting Development Agreements. No later than 30 days prior the date on which Biogen reasonably anticipates that it will exercise an Option, Biogen Idec will so notify Isis and the pharmacovigilance departments of each of Isis and Biogen Idec will meet and determine the approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the applicable Product occurring after such First Commercial Sale, consistent with the provisions of this Section 5.2. Such approach will be managed by both Parties, how the safety databases for the Products will be set up documented in a separate and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements of the Regulatory Authorities; (c) include provisions regarding producing outputs (tables, line listings) and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reports. At least [**] days before the estimated date of the first Regulatory Approval of the first Product in the Sobi Territory, appropriate written pharmacovigilance agreement between the Parties shall commence discussions which will control with respect to the amendment subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will specify that the owner of the IND for a Product will be the global commercial safety database owner for such Product with primary responsibility for maintaining such database, and that Isis will be and remain the owner of the Isis Internal ASO Safety Database with primary responsibility for maintaining such database. Such agreement will also specify that, prior to Biogen Idec’s exercise of the applicable Option, Isis will communicate updates on safety data regarding a Product to Biogen Idec through monthly telephone calls between the drug safety representatives of Biogen Idec and Isis. Biogen Idec and Isis will jointly review and discuss safety issues arising under any Collaboration Program that may have implications on any Development Plan for such Collaboration Program. Biogen Idec may suggest actions to address Product safety data or audit findings, and Isis will consider all such suggestions in good faith. The Pharmacovigilance Agreement to set forth the Parties’ respective obligations will be in detail regarding pharmacovigilance accordance with, and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and will enable the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first and their Affiliates or licensees or Sublicensees, as applicable, to fulfill, local and international regulatory reporting obligations to Regulatory Approval of the first Product in the Sobi TerritoryAuthorities and other Applicable Law.

Pharmacovigilance Agreement. Promptly As soon as reasonably practicable following the Effective Datedesignation of a particular Development Candidate, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations and in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement any event no later than [***] days after prior to the Effective Date. In date on which Ionis anticipates filing an IND for the Pharmacovigilance Agreementassociated Product with a Regulatory Authority, the Parties shall define how clinical safety will enter into a Safety Data Exchange Agreement relating to the collection, review, assessment, tracking, exchange and pharmacovigilance will be managed by both Parties, how filing of information related to adverse events associated with such Product occurring prior to the safety databases for First Commercial Sale in any country on terms substantially the Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in same as the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements terms of the Regulatory Authorities; (c) include provisions regarding producing outputs (tables, line listings) and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reportsSafety Data Exchange Agreement to be entered into by the Parties with respect to adverse events associated with products developed under the Ionis/Biogen Additional Agreements. At least No later than [***] days before prior to the estimated date on which Biogen reasonably anticipates that it will exercise an Option, Biogen will so notify Ionis and the pharmacovigilance departments of each of Ionis and Biogen will meet and determine the first Regulatory Approval approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the first applicable Product occurring after such First Commercial Sale, consistent with the provisions of this Section 5.2. Such approach will be documented in the Sobi Territory, a separate and appropriate written pharmacovigilance agreement between the Parties shall commence discussions which will control with respect to the amendment subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will specify that the owner of the IND for a Product will be the global commercial safety database owner for such Product with primary responsibility for maintaining such database, and that Ionis will be and remain the owner of the Ionis Internal ASO Safety Database with primary responsibility for maintaining such database. Such agreement will also specify that, prior to Biogen’s exercise of the applicable Option, Ionis will communicate updates on safety data regarding a Product to Biogen through monthly telephone calls between the drug safety representatives of Biogen and Ionis. Biogen and Ionis will jointly review and discuss safety issues arising under any Collaboration Program that may have implications on any Development Plan for such Collaboration Program. Biogen may suggest actions to address Product safety data or audit findings, and Ionis will consider all such suggestions in good faith. The Pharmacovigilance Agreement to set forth the Parties’ respective obligations will be in detail regarding pharmacovigilance accordance with, and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and will enable the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first and their Affiliates or licensees or Sublicensees, as applicable, to fulfill, local and international regulatory reporting obligations to Regulatory Approval of the first Product in the Sobi TerritoryAuthorities and other Applicable Law.

Pharmacovigilance Agreement. Promptly As soon as reasonably practicable following the Effective Datedesignation of a particular Development Candidate, the Parties shall discuss a mutually acceptable pharmacovigilance agreement (“Pharmacovigilance Agreement”) setting forth the Parties’ respective obligations and in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the first Regulatory Approval of the first Product in the Sobi Territory and the Parties shall enter into such Pharmacovigilance Agreement any event no later than [***] days after prior to the Effective Date. In date on which Ionis or Biogen anticipates filing an IND for the Pharmacovigilance Agreementassociated Collaboration Product with a Regulatory Authority, the Parties shall define how clinical safety will enter into a Safety Drug Exchange Agreement relating to the collection, review, assessment, tracking, exchange and pharmacovigilance will be managed by both Parties, how filing of information related to adverse events associated with such Collaboration Product occurring prior to the safety databases for First Commercial Sale in any country on terms substantially the Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in same as the global safety database; (b) provide for submitting expedited reports in the agreed format to Regulatory Authorities, in accordance with the requirements terms of the Regulatory Authorities; (c) include provisions regarding producing outputs (tablesSafety Drug Exchange Agreement to be entered into by the Parties with respect to adverse events associated with products developed under the Ionis/Biogen Additional Agreements. In addition, line listings) following the First Amendment Date the Parties will discuss in good faith the possibility of entering into a single Safety Drug Exchange Agreement with respect to all activities under this Agreement and preparation of aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk and preparation of risk management plans; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reportsthe Ionis/Biogen Additional Agreements. At least No later than [***] days before prior the estimated date on which Biogen reasonably anticipates that it will exercise an Option, Biogen will so notify Ionis and the pharmacovigilance departments of each of Ionis and Biogen will meet and determine the first Regulatory Approval approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the first applicable Collaboration Product occurring after such First Commercial Sale, consistent with the provisions of this Section 5.2. Such approach will be documented in the Sobi Territory, a separate and appropriate written pharmacovigilance agreement between the Parties shall commence discussions which will control with respect to the amendment subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will specify that the owner of the IND for a Collaboration Product will be the global commercial safety database owner for such Collaboration Product with primary responsibility for maintaining such database, and that Ionis will be and remain the owner of the Ionis Internal ASO Safety Database with primary responsibility for maintaining such database. Such agreement will also specify that, prior to the License Effective Date for a particular Collaboration Program, the Parties will communicate updates on safety data regarding a Collaboration Product to Biogen through monthly telephone calls between the drug safety representatives of Biogen and Ionis. Biogen and Ionis will jointly review and discuss safety issues arising under any Collaboration Program that may have implications on any Initial Development Plan for such Collaboration Program. Biogen may suggest actions to address Collaboration Product safety data or audit findings, and Ionis will consider all such suggestions in good faith. The Pharmacovigilance Agreement to set forth the Parties’ respective obligations will be in detail regarding pharmacovigilance accordance with, and the exchange of Safety Data during the period after the first Regulatory Approval of the first Product in the Sobi Territory and will enable the Parties shall enter into such mutually acceptable amended Pharmacovigilance Agreement at least [**] before the estimated date of the of the first and their Affiliates or licensees or Sublicensees, as applicable, to fulfill, local and international regulatory reporting obligations to Regulatory Approval of the first Product in the Sobi TerritoryAuthorities and other Applicable Law.