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 immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection, or communication by or from any party, including without limitation a Governmental Authority, that may affect the safety or efficacy claims of the Product, the continued marketing of the Product, or that otherwise suggests the Product may be in violation of Applicable Laws. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. The Parties shall allocate all costs and expenses associated with taking such action as is described with regard to Remedial Actions in Section 5.7(b). Other than with respect to Product for the PNE Indication Developed or Commercialized by Serenity, each Party shall keep the other Party informed, in a timely manner and in any event in compliance compliant with the reporting requirements of Regulatory Authorities in the Licensed TerritoryAuthorities, of notification of any action byby any Regulatory Authority, or notification or other information which that the first Party receives (directly or indirectly) from any such Regulatory Authority, and provide to such other Party copies of all documents, if any, it received from such Regulatory Authority. If any communication from a Regulatory Authority which: (a) raises any [*] of the Product; (b) indicates or suggests [*] in connection with the Product; (c) is reasonably likely pertains to lead to [*] of the Product; or (d) relates to [*] Development activities performed by Serenity with respect to Product other than Product for the ProductPNE Indication Developed or Commercialized by Serenity, or [*]Serenity will prepare, and which may have [*] promptly enough to enable adequate time to prepare a response to the ProductRegulatory Authorities, 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 such communication, including without limitation preparing any additional analyses and documents, and provide to Allergan any and all documents requested by such Regulatory Authority, as may be necessary or helpful for Allergan to review and approve Serenity’s response to an inquiry from a Regulatory Authority. Serenity shall be ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. responsible for submitting Party shall have an opportunity any and all such responses to comment on the responsesuch Regulatory Authority. In the event If the Parties disagree concerning the form or content of such a response to a Regulatory Authority in a particular country of the Licensed Territoryterritory, the Party who has responsibility for content preparation Allergan shall decide the appropriate form and content of such response, without recourse . Any additional work resulting from the preparation for such a response will be conducted by Serenity unless otherwise agreed to arbitration under Section 2.4(c)by Allergan. The other Party shall fully cooperate with and assist If Serenity is required to provide 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 any Regulatory Authority, Serenity shall seek the input and approval of Allergan before responding. Serenity shall also provide Allergan in a timely manner with a copy of all correspondence received from a Regulatory Authority. For clarity, each Party's obligations under this Section 4.8 shall apply to any such communications Authority specifically regarding the matters referred to above received above. Serenity shall permit Allergan to access, and shall provide Allergan with rights to reference and use in association with the Product, all of its, its Affiliates’, and its or their Sublicensees’ regulatory, preclinical, CMC, and clinical data documentation, Regulatory Filings, and Regulatory Approvals with respect to the Product other than Product for the PNE Indication Developed or Commercialized by Serenity. Allergan shall be entitled to provide such Party's Affiliate(s), contractors, partners, or other collaborators as if such communications had been received by such Party directlydata to its Affiliates and Sublicensees.

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.