Common use of Regulatory Cooperation Clause in Contracts

Regulatory Cooperation. The Party responsible for carrying out a regulatory activity pursuant to this Agreement or having primary FDA contact responsibility will keep the other Party reasonably informed regarding the status and progress of such activity, including without limitation, providing the other Party with advance notice of all meetings scheduled with a Regulatory Authority (including notice within twenty-four (24) hours of a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, and an agenda and an invitation to attend such meetings, providing the other Party with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently in advance of providing the submission to the Regulatory Authority (and in any event no less than seven days in advance) to enable the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable Law, shall both have the right to participate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relate.

Regulatory Cooperation. The Subject to applicable Law, each Party responsible for carrying out shall have the right [***] pertaining to Development of the Cost Profit Sharing Products in the Field or Regulatory Approval of a regulatory activity pursuant Cost Profit Sharing Products [***]. Each Party shall, to this Agreement or having primary FDA contact responsibility will keep the other Party reasonably informed regarding the status and progress of such activityextent possible, including without limitation, providing provide the other Party with reasonable advance notice of all such meetings scheduled and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact. Each Party shall provide the Clinical/Regulatory Working Group with advance drafts of any material documents or other material correspondence pertaining to Regulatory Approvals, including any proposed labeling, that such Party plans to submit to any Regulatory Authority and keep the Clinical/Regulatory Working Group informed of all material regulatory interactions with Regulatory Authorities that pertain to the Cost Profit Sharing Products in each case in [***]. The Clinical/Regulatory Working Group may provide comments regarding such documents and other correspondence prior to their submission, which comments the submitting Party shall consider in good faith. Each Party shall provide the other Party (through the Clinical/Regulatory Working Group) with copies of all material submissions it makes to, and all material correspondence it receives from, a Regulatory Authority (including notice within twenty-four (24) hours of a request for a meeting received from pertaining to a Regulatory Authority) involving a Regulatory SubmissionApproval that pertains to the Cost Profit Sharing Products. Notices, copies of submissions and correspondence, and an agenda and an invitation other materials to attend such meetings, providing the other Party with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently be given in advance of providing the submission to the Regulatory Authority as provided in this Section 4.4.3 shall be provided at least [***] *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. [***] in advance unless circumstances necessitate a shorter time period, and in any event no not less than seven days in advance) to enable the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree reasonable time in advance on all substantive written communications with and, to under the extent permitted by Applicable Law, shall both have the right to participate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relatecircumstances.

Regulatory Cooperation. The (a) Each Party responsible for carrying out a regulatory activity pursuant shall use commercially reasonable efforts to this Agreement or having primary FDA contact responsibility will keep provide the other Party with all reasonable assistance and take all actions reasonably requested by such other Party, without changing the allocation of responsibilities set forth in this Section 9 (Regulatory), that are necessary or desirable to enable: (i) Cxxxxx to seek, obtain, and maintain Regulatory Approvals for the Licensed Products in the Field in the Collaborative Territory; and (ii) CSPC to seek, obtain, and maintain Regulatory Approvals for Licensed Products outside the Collaborative Territory or outside the Field or for Manufacturing of the Licensed Products worldwide. Each Party shall cooperate with any inspection by any Regulatory Authority relating to Licensed Products in the Field in the Collaborative Territory, including any inspection prior to approval of an application for Regulatory Approval for Licensed Products. (b) Each Party shall keep the JSC reasonably and timely informed regarding the status and progress of such activityits activities conducted with respect to Licensed Products in the Field, both inside and outside the Collaborative Territory, including without limitation, providing the other Party JSC with advance notice of all meetings scheduled with a Regulatory Authority (including providing notice within twenty-four (24) hours of promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, and an agenda and an invitation to attend such meetings, providing the other Party JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing such other Party the JSC with an advance draft of each proposed Regulatory Submission sufficiently in advance of providing the submission submitted to the a Regulatory Authority (and in any event no less than seven days in advance) to enable the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable Law, shall both have the right to participate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relateAuthority.

Regulatory Cooperation. The Party responsible for carrying out a regulatory activity pursuant to this Agreement or having primary FDA contact responsibility will keep the other Party reasonably informed regarding the status and progress of such activity, including without limitation, providing the other Party with advance notice of all meetings scheduled with a Regulatory Authority (including notice within twenty-four (24) hours of a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, and an agenda and an invitation to attend such meetings, providing the other Party with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently in advance of providing the submission to the Regulatory Authority (and in any event no less than seven days in advance) to enable the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable Law, shall both have the right to participate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relate[**].

Regulatory Cooperation. (a) The Parties shall disclose to each other all reports or other knowledge they receive with respect to adverse experiences, and reports of mislabeling, stability failures or microbiological contamination. (b) In addition to and without limiting the requirements of Section 8.3(a) above, Fidopharm and ** agree, throughout the duration of this Agreement, to notify the other Party responsible immediately of any information concerning any serious or unexpected side effect, injury, toxicity or sensitivity reaction, or any unexpected incidents, and the severity thereof, associated with the clinical uses, studies, investigations, tests and marketing of Products, whether or not determined to be attributable to Products. Each Party shall cooperate with the other to resolve any complaints received by either Party with respect to Products. (c) Each of Fidopharm and ** shall promptly deliver to the other all material correspondence that such Party may receive, directly or indirectly, from regulatory authorities in jurisdictions where such Party (or its sublicensees, distributors, or sub-distributors) has rights to market Products, except for carrying out procedural, nonsubstantive communications which do not relate to the safety or efficacy of Products. Fidopharm and ** shall also immediately notify the other Party about any information such Party receives regarding any threatened or pending action by a governmental agency that may affect the safety and efficacy claims of Products or the continued marketing, promotion, distribution, sale or manufacture of Products. Upon receipt of any such information, the Parties shall consult in an effort to arrive at a mutually acceptable procedure for taking appropriate action, provided that nothing contained herein shall be construed as restricting either Party’s right to make a timely report of such matter to any governmental or regulatory activity pursuant agency or take other action that it deems to be appropriate or required by applicable law or regulation. It is Fidopharm’s responsibility to report adverse events in accordance with local Laws and requirements to governmental or regulatory agencies in the Territory. (d) Without limiting the foregoing, it is also understood that each Party may notify any of its Affiliates, licensees, distributors or sub-licensees of any incident or event reported by either Party under this Agreement Section 8.3. In addition, each Party shall, and shall require its respective Affiliates to: (i) to the extent permissible under time constraints and reporting requirements, provide to the other Party in advance of initial or having primary FDA contact responsibility will periodic submission to the applicable regulatory authorities any and all adverse event reports from clinical trials and commercial experiences with Products; (ii) provide such adverse event reports to the other Party contemporaneously with the provision of such reports to the applicable regulatory authority; and (iii) adhere to all requirements of applicable Laws which relate to the reporting and investigation of adverse events and keep the other Party reasonably informed regarding the status and progress of such activity, including without limitation, providing the other events. If a Party with advance notice of all meetings scheduled contracts with a Regulatory Authority (including notice within twenty-four (24) hours of a request Third Party for a meeting received from a Regulatory Authority) involving a Regulatory Submissionany research to be performed by such Third Party on Products, and an agenda and an invitation that Party shall require such Third Party to attend such meetings, providing the other Party with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently in advance of providing the submission report to the Regulatory Authority (and in any event no less than seven days in advance) to enable contracting Party the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable Law, shall both have the right to participate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relateinformation set forth above.

Regulatory Cooperation. The (a) Subject to applicable Law and Section 4.4.2 and this Section 4.4.3, the Party responsible for carrying out filing and holding Regulatory Filings and obtaining and maintaining Marketing Authorizations in a particular territory in accordance with Section 4.4.1 (“Regulatory Owner”) shall oversee, monitor and manage all regulatory activity interactions, communications and filings with, and submissions to, Regulatory Authorities with respect to the Products in such territory. The Regulatory Owner shall have final decision making authority regarding all regulatory activities, including the labeling strategy and the content of submissions within such territory, subject to the Global Branding Strategy and the terms and conditions of this Agreement, and the right of the non-owning Party to review and comment on such strategies and submissions. The Regulatory Owner shall ensure that the manner in which a Product shall be presented and described to the medical community in any Promotional Materials and the placement of names and logos of the Parties therein, as permitted by applicable Law, is consistent with the labeling for such Product approved by the applicable Regulatory Authority. To the extent required under applicable Law, the Regulatory Owner shall submit any Promotional Materials for use in the territory for which it is responsible, which have been approved pursuant to this Agreement or having primary FDA contact responsibility will keep Agreement, to the applicable Regulatory Authorities. (b) Subject to applicable Law, each Party shall have the right to attend, in an observer role only, all material meetings, conferences and discussions by the other Party reasonably informed regarding or its Affiliate with Regulatory Authorities pertaining to the status and progress Development or Regulatory Approval of such activity, including without limitation, providing the Products in the Field. Each Party shall provide the other Party with reasonable advance notice of all meetings scheduled such interactions and will provide advance copies of all related documents and other relevant information relating to such interactions. Each Party shall provide the JDC and the JSC with a advance drafts of any material documents or other material correspondence pertaining to Regulatory Authority (Approvals of the Products, including notice within twenty-four (24) hours of a request for a meeting received from a any proposed labeling, that such Party plans to submit to any Regulatory Authority) involving a Regulatory Submission. The JDC may provide comments regarding such documents and other correspondence prior to their submission, and an agenda and an invitation to attend such meetings, providing which comments the submitting Party shall consider in good faith. Each Party shall provide the other Party with a copy copies of all substantive written material submissions it makes to, and all material correspondence from it receives from, a Regulatory Authority involving pertaining to a Regulatory SubmissionApproval of a Product. Notices, notifying the other Party copies of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submissionsubmissions and correspondence, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently materials to be given in advance of providing the submission to the Regulatory Authority (as provided in this Section 4.43(b) shall be provided at least [**] Business Days in advance unless circumstances necessitate a shorter time period, and in any event no not less than seven days a reasonable time in advanceadvance under the circumstances. (c) Each Party shall make every reasonable effort to enable notify the other Party promptly upon its determination that any event, incident or circumstance has occurred that may result in the need for a Recall, market withdrawal or stock recovery of a Product (but in no event later than [**] hours and in all cases prior to have a meaningful opportunity to provide comments on the content execution of such submission Recall, market withdrawal or stock recovery). For all Recalls, market withdrawals and no such submission (including any NDA) stock recoveries that are taken, the Regulatory Owner shall be submitted responsible for filing with execution, and the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties other Party shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable Law, shall both have the right to participate reasonably cooperate in all meetings and oral communications with Regulatory Authorities in the applicable countries in the Territory to the extent related to the Product. All costs and expenses incurred by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses or Commercialization Expenses, depending on the activities to which such costs relateefforts.

Regulatory Cooperation. The Party responsible for carrying out a regulatory activity pursuant Subject to this Agreement or having primary FDA contact responsibility will keep the other Party reasonably informed regarding the status and progress of such activity, including without limitation, providing the other Party with advance notice of all meetings scheduled with a Regulatory Authority (including notice within twenty-four (24) hours of a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, and an agenda and an invitation to attend such meetings, providing the other Party with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the other Party of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and providing such other Party with an advance draft of each proposed Regulatory Submission sufficiently in advance of providing the submission to the Regulatory Authority (and in any event no less than seven days in advance) to enable the other Party to have a meaningful opportunity to provide comments on the content of such submission and no such submission (including any NDA) shall be submitted for filing with the Regulatory Authority without the mutual agreement of the Parties, such consent not to be unreasonably withheld or delayed. Furthermore, the Parties shall agree in advance on all substantive written communications with and, to the extent permitted by Applicable applicable Law, [*] shall both have the right to participate in the Regulatory Filing and Regulatory Approvals submitted and owned by [*] by having at least [*] representative present at all meetings material meetings, conferences and oral communications discussions by [*] or its Affiliate with Regulatory Authorities pertaining to Development of the Licensed Products in the applicable countries Field or Regulatory Approval. [*] shall provide [*] with reasonable advance notice of all such meetings and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact for the [*] to review and comment on. [*] shall provide the JRS with advance drafts of any material documents or other material correspondence pertaining to Regulatory Approvals, including any proposed labelling, [*] plans to submit to any Regulatory Authority. The JRS shall (A) [*] and (B) [*]. [*] may submit any such Regulatory Filing to a Regulatory Authority in the Territory without [*]. In the event that the JRS is unable to agree, such matter shall be referred to the extent related JSC for approval. If the JSC is unable to agree such matter, [*] (which, for the Productavoidance of doubt, in each case shall not be subject to challenge, review or arbitration). All costs [*] shall provide the JRS with copies of all material submissions it makes to, and expenses incurred all material correspondence it receives from, a Regulatory Authority pertaining to a Regulatory Approval. Notices, copies of submissions and correspondence, and other materials to be given in advance shall be provided at least [*] in advance unless circumstances necessitate a shorter time period, and in any event not less than a reasonable time in advance under the circumstances. Each Party shall support the other Party, as may be reasonably necessary or appropriate, in obtaining Regulatory Approvals for the Licensed Products in accordance with the responsibilities allocated to such Parties under clause 6.6.2, including by the Parties in carrying out its allocated regulatory activities pursuant to this Agreement will be included as Development Expenses providing necessary documents or Commercialization Expenses, depending on the activities to which such costs relateother materials required by applicable Law or by request of any Regulatory Authority.