Common use of Regulatory Authority Communications Received by a Party Clause in Contracts

Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed, in a timely manner and in any event in compliance with the reporting requirements of Regulatory Authorities in the Licensed Territory, of notification of any action by, or notification or other information which the first Party receives (directly or indirectly) from any such Regulatory Authority which: (a) raises any [*] of the Product; (b) indicates or suggests [*] in connection with the Product; (c) is reasonably likely to lead to [*] of the Product; or (d) relates to [*] with respect to the Product, or [*], and which may have [*] the Product, the Peptide, [*] or Hematide. The Party identified in 4.2(a) as being responsible for preparing and authoring the content of documents and components of regulatory submissions shall be responsible for preparing the response to the communication, and the Party identified as being responsible for building, submitting and maintaining submission components will submit the response. However, before submitting such response to a Regulatory Authority regarding the communication, the submitting Party shall have an opportunity to comment on the response. In the event the Parties disagree concerning the form or content of a response to a Regulatory Authority in a particular country of the Licensed Territory, the Party who has responsibility for content preparation shall decide the appropriate form and content of such response, without recourse to arbitration under Section 2.4(c). The other Party shall fully cooperate with and assist such Party in complying with such regulatory obligations and communications, including by providing to such Party, within two (2) Business Days after a request or as quickly as practicable thereafter, such information and documentation in the other Party's possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. For clarity, each Party's obligations under this Section 4.8 shall apply to any such communications regarding the matters referred to above received by such Party's Affiliate(s), contractors, partners, or other collaborators as if such communications had been received by such Party directly.

Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed, informed in a timely manner manner, and in any event in compliance compliant with the reporting requirements of the applicable Regulatory Authorities in the Licensed TerritoryAuthorities, of notification of any action by, or notification or other information which the first Party it receives (directly or indirectly) from any such Regulatory Authority (inside or outside of the Licensed Territory as applicable) which: (a) raises any [*] material concerns regarding the safety or efficacy of the Licensed Product; (b) indicates or suggests [*] a potential material liability of either Party to Third Parties in connection with the ProductLicensed Product in the Field in the Licensed Territory; (c) is reasonably likely to lead to [*] a recall or market withdrawal of the Licensed Product; or (d) relates to [*] expedited and periodic reports of Adverse Events with respect to the Product, or [*], Licensed Product and which may have [*] a material impact on obtaining or maintaining Marketing Approval or the Product, continued commercialization of the Peptide, [*] or Hematide. The Party identified Licensed Product in 4.2(a) as being responsible for preparing and authoring the content of documents and components of regulatory submissions shall be responsible for preparing the response to the communication, and the Party identified as being responsible for building, submitting and maintaining submission components will submit the response. However, before submitting such response to a Regulatory Authority regarding the communication, the submitting Party shall have an opportunity to comment on the response. In the event the Parties disagree concerning the form or content of a response to a Regulatory Authority in a particular country of the Licensed Territory, as then conducted; or (e) relates to any dissatisfaction regarding the Party who has responsibility for content preparation shall decide Licensed Product in the appropriate form and content Licensed Territory of such responsea nature and magnitude that it is required under the Applicable Law to be collected, without recourse maintained and reported to arbitration under Section 2.4(c)a Regulatory Authority, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients. The Each Party shall provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above. Karuna shall fully reasonably cooperate with and assist such Party Xxx in complying with such regulatory obligations and communications, including by providing to such PartyZai, within two (2) Business Days after in a request or as quickly as practicable thereaftertimely manner upon request, such information and documentation in the other Party's Karuna’s possession or Control as may be necessary or helpful for the Party Xxx to prepare a response to an inquiry from a any Regulatory AuthorityAuthority regarding the Licensed Product in the Licensed Territory. For clarity, each Party's obligations under To the extent there are any inconsistencies or conflicts between this Section 4.8 5.7 and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall apply control, unless otherwise agreed to any such communications regarding in writing by the matters referred to above received by such Party's Affiliate(s), contractors, partners, or other collaborators as if such communications had been received by such Party directlyParties.

Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed, in a timely manner and in any event in compliance with the reporting requirements of Regulatory Authorities in the Licensed Territory, of notification of any action by, or notification or other information which the first Party receives (directly or indirectly) from any such Regulatory Authority which: (a) raises any [*[ * ] of the Product; (b) indicates or suggests [*[ * ] in connection with the Product; (c) is reasonably likely to lead to [*[ * ] of the Product; or (d) relates to [*[ * ] with respect to the Product, or [*[ * ], and which may have [*[ * ] the Product, the Peptide, [*[ * ] or Hematide. The Party identified in 4.2(a) as being responsible for preparing and authoring the content of documents and components of regulatory submissions shall be responsible for preparing the response to the communication, and the Party identified as being responsible for building, submitting and maintaining submission components will submit the response. However, before submitting such response to a Regulatory Authority regarding the communication, the submitting Party shall have an opportunity to comment on the response. In the event the Parties disagree concerning the form or content of a response to a Regulatory Authority in a particular country of the Licensed Territory, the Party who has responsibility for content preparation shall decide the appropriate form and content of such response, without recourse to arbitration under Section 2.4(c). The other Party shall fully cooperate with and assist such Party in complying with such regulatory obligations and communications, including by providing to such Party, within two (2) Business Days after a request or as quickly as practicable thereafter, such information and documentation in the other Party's ’s possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. For clarity, each Party's ’s obligations under this Section 4.8 shall apply to any such communications regarding the matters referred to above received by such Party's ’s Affiliate(s), contractors, partners, or other collaborators as if such communications had been received by such Party directly.