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

Regulatory Authority Communications Received by a Party. Prior to Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (a) relates to the potential approvability of the Product; or (b) raises any material concerns regarding the safety or efficacy of a Product; or (c) which may have a material impact on obtaining Regulatory Approvals. Following Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (a) indicates or suggests a potential material liability of Harrow to Third Parties in connection with a Product; (b) is reasonably likely to lead to a recall or market withdrawal of a Product; or (c) relates to expedited and periodic reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on maintaining Regulatory Approvals or the continued Commercialization of a Product, as then conducted. Once an NDA has been transferred to Harrow, Harrow shall provide to Sintetica copies of all correspondence to or from the FDA or Health Canada, as appropriate, relating to the Product, including without limitation to any post-approval changes (Annual Reports, CXX-0, XXX-00, PAS or similar filings) submitted to the FDA or Health Canada. In particular, all the documentation generated after the approval of the NDA should be shared with Sintetica (e.g., any eCTD sequences filed to FDA), to ensure Sintetica has availability of the complete dossier. Harrow shall fully cooperate with and assist Sintetica in complying with regulatory obligations and communications, including by providing to Sintetica, in a timely manner after a request, such Information and documentation in Harrow’s possession as may be necessary or helpful for Sintetica to prepare a response to an inquiry from a Regulatory Authority.

Regulatory Authority Communications Received by a Party. Prior to Regulatory Approval of an NDA, each Each Party shall keep the other Party informed in a timely manner, manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory, but in any event within five (5) business days or such shorter time period set forth in the Pharmacovigilance Agreement and/or SOPs, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from from, any regulatory authority which, in relation to such NDARegulatory Authority that: (a) relates to the potential approvability of the Product; or (bi) raises any material concerns regarding the safety or efficacy of a the Product; or (c) which may have a material impact on obtaining Regulatory Approvals. Following Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (aii) indicates or suggests a potential material liability of Harrow either Party to Third Parties in connection with a the Product; (biii) is reasonably likely to lead to a recall or market withdrawal of the Product or a discontinuation of clinical studies for the Product; or (civ) relates to expedited and periodic reports of adverse events with respect to a the Product, or Product Complaints, and in each case which may have a material impact on maintaining Regulatory Approvals Approval or the continued Commercialization of a Product, as then conductedthe Product anywhere in the world. Once an NDA has been transferred to Harrow, Harrow shall provide to Sintetica copies of all correspondence to or from the FDA or Health Canada, as appropriate, relating to the Product, including without limitation to any post-approval changes (Annual Reports, CXX-0, XXX-00, PAS or similar filings) submitted to the FDA or Health Canada. In particular, all the documentation generated after the approval of the NDA should be shared with Sintetica (e.g., any eCTD sequences filed to FDA), to ensure Sintetica has availability of the complete dossier. Harrow shall The other Party will fully cooperate with and assist Sintetica such Party in complying with regulatory obligations and communications, including by providing to Sinteticasuch Party, in a timely manner after a request, such Information information and documentation in Harrowthe other Party’s possession as may be necessary or helpful for Sintetica the Party to prepare a response to an inquiry from a Regulatory Authority. Each Party will 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. The Pharmacovigilance Agreement shall set forth the procedures by which each Party shall report and maintain safety data and prescription events monitoring. In addition to the foregoing and subject to applicable Laws, AMAG shall promptly provide Takeda with a copy of all material correspondence received from the FDA and any material reply correspondence by AMAG, in each case that is reasonably likely to have a material impact on the Development, Manufacture and/or Commercialization of the Product in the Licensed Territory; provided that AMAG may redact AMAG’s Confidential Information (including CMC Information) from any such correspondence provided to Takeda, and if required by a Regulatory Authority in the Licensed Territory, AMAG shall submit any such redacted correspondence, without redactions, directly to such Regulatory Authority and not to Takeda The Parties shall determine as soon as reasonably practicable after the Effective Date what types of regulatory correspondence shall be considered “material”. In the event a material correspondence relating to CMC Information occurs, the Parties shall cooperate to adequately and appropriately address the matter and, if and only to the extent necessary, AMAG shall disclose the subject CMC information to the CMC Recipients, who shall not disclose it to any other Takeda personnel.

Regulatory Authority Communications Received by a Party. Prior 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 Regulatory Approval of an NDAarrive 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 informed, in a timely manner, manner compliant with the reporting requirements of Regulatory Authorities in the TerritoryAuthorities, of the notification of any action byby any Regulatory Authority, or notification or other information which it that the first Party receives (directly or indirectly) from any regulatory authority whichsuch Regulatory Authority, in relation and provide to such NDA: (a) relates to the potential approvability of the Product; or (b) raises any material concerns regarding the safety or efficacy of a Product; or (c) which may have a material impact on obtaining Regulatory Approvals. Following Regulatory Approval of an NDA, each Party shall keep the other Party informed in copies of all documents, if any, it received from such Regulatory Authority. If any communication from a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation Authority pertains to such NDA: (a) indicates or suggests a potential material liability of Harrow to Third Parties in connection with a Product; (b) is reasonably likely to lead to a recall or market withdrawal of a Product; or (c) relates to expedited and periodic reports of adverse events Development activities performed by Serenity with respect to Product other than Product for the PNE Indication Developed or Commercialized by Serenity, Serenity will prepare, promptly enough to enable adequate time to prepare a Product, or Product Complaints, and which may have a material impact on maintaining Regulatory Approvals or the continued Commercialization of a Product, as then conducted. Once an NDA has been transferred to Harrow, Harrow shall provide to Sintetica copies of all correspondence to or from the FDA or Health Canada, as appropriate, relating response to the ProductRegulatory Authorities, the response to such Regulatory Authority regarding such communication, including without limitation preparing any additional analyses and documents, and provide to Allergan any post-approval changes (Annual Reportsand all documents requested by such Regulatory Authority, CXX-0, XXX-00, PAS or similar filings) submitted to the FDA or Health Canada. In particular, all the documentation generated after the approval of the NDA should be shared with Sintetica (e.g., any eCTD sequences filed to FDA), to ensure Sintetica has availability of the complete dossier. Harrow shall fully cooperate with and assist Sintetica in complying with regulatory obligations and communications, including by providing to Sintetica, in a timely manner after a request, such Information and documentation in Harrow’s possession as may be necessary or helpful for Sintetica Allergan to prepare a 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 any and all such responses to such Regulatory Authority. If the Parties disagree concerning the form or content of such a response to a Regulatory Authority in a particular territory, Allergan shall decide the appropriate form and content of such response. Any additional work resulting from the preparation for such a response will be conducted by Serenity unless otherwise agreed to by Allergan. If Serenity is required to provide such a response to 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 specifically regarding the matters referred to 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 data to its Affiliates and Sublicensees.

Regulatory Authority Communications Received by a Party. Prior to Regulatory Approval of an NDA, each Each Party shall keep the other Party informed in a timely manner, and compliant with the reporting requirements of the applicable Regulatory Authorities in the TerritoryAuthorities, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority Regulatory Authority (inside or outside of the Licensed Territory as applicable) which, in relation to such NDA: (a) relates to the potential approvability of the Product; or (b) raises any material concerns regarding the safety or efficacy of a the Licensed Product; or (c) which may have a material impact on obtaining Regulatory Approvals. Following Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (ab) indicates or suggests a potential material liability of Harrow either Party to Third Parties in connection with a Productthe Licensed Product in the Field in the Licensed Territory; (bc) is reasonably likely to lead to a recall or market withdrawal of a the Licensed Product; or (cd) relates to expedited and periodic reports of adverse events Adverse Events with respect to a Product, or the Licensed Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approvals Marketing Approval or the continued Commercialization commercialization of a Productthe Licensed Product in the Licensed Territory, as then conducted; or (e) relates to any dissatisfaction regarding the Licensed Product in the Licensed Territory of such a nature and magnitude that it is required under the Applicable Law to be collected, maintained and reported to a Regulatory Authority, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients. Once an NDA has been transferred to Harrow, Harrow Each Party shall provide to Sintetica copies the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to or from the FDA or Health Canada, as appropriate, relating to the Product, including without limitation to any post-approval changes (Annual Reports, CXX-0, XXX-00, PAS or similar filings) submitted to the FDA or Health Canadaabove. In particular, all the documentation generated after the approval of the NDA should be shared with Sintetica (e.g., any eCTD sequences filed to FDA), to ensure Sintetica has availability of the complete dossier. Harrow Karuna shall fully reasonably cooperate with and assist Sintetica Xxx in complying with regulatory obligations and communications, including by providing to SinteticaZai, in a timely manner after a upon request, such Information information and documentation in HarrowKaruna’s possession or Control as may be necessary or helpful for Sintetica Xxx to prepare a response to an inquiry from a any Regulatory AuthorityAuthority regarding the Licensed Product in the Licensed Territory. To the extent there are any inconsistencies or conflicts between this Section 5.7 and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control, unless otherwise agreed to in writing by the Parties.