Common use of Meetings and Communications Clause in Contracts

Meetings and Communications. During the Collaboration Term, each Party will keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Shared Global Development Activities performed under this Agreement promptly following receipt thereof. In addition, during the Collaboration Term, to the extent relating to a Licensed Product, the applicable Regulatory Responsible Party will provide the other Party with: (a) to the extent allowable by Applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Trials or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory Authority; and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. To the extent practicable, each Party will use Commercially Reasonable Efforts to provide all such documents or reports described in clause (b) above to the non-Regulatory Responsible Party at least [**] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faith. During the Collaboration Term, to the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Licensed Product or activities under this Agreement, such Party shall notify the other Party and provide a copy of any such written communications to the other Party within [**]. In addition, during the Collaboration Term, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Licensed Products.

Meetings and Communications. During the Target Discovery Phase and the Early Research Phase of any Collaboration TermProgram, each Party will shall keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Shared Global Research and Development Activities activities performed under this Agreement promptly following receipt thereofAgreement. In addition, during the Collaboration Term, to To the extent relating to a Licensed Joint Compound or Joint Product, the applicable Party that is the regulatory sponsor or owner of a Regulatory Responsible Party will Filing shall provide the other Party with: (a) to the extent allowable by Applicable applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe (but not participate unless specifically agreed to by the regulatory sponsor or owner in advance) in substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Trials Studies or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory Authority; and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. To the extent practicable, each Party will use Commercially Reasonable Efforts to provide all All such documents or reports described in clause (b) above shall be provided to the non-Regulatory Responsible Party JDC at least [***] days prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faithAuthority. During the Collaboration Term, to To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Licensed Joint Compound or Joint Product in the Field or activities under this AgreementAgreement with respect to a Joint Compound or Joint Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party as soon as reasonably practicable, except in the United States where such communications will be provided within [**]twenty-four (24) hours of receipt. In addition, during the Collaboration Term, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Licensed Joint Compounds or Joint Products in the Field or activities under this Agreement with respect to Joint Compounds or Joint Products.

Meetings and Communications. During the Collaboration Term, each Party will keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Shared Global Development Activities activities (including Additional Development Activities) performed under this Agreement promptly following receipt thereof. In addition, during the Collaboration Term, to To the extent relating to a Licensed Product, the applicable Regulatory Responsible Party with respect to such Licensed Product, will provide the other Party with: (a) to the extent allowable by Applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Trials or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory AuthorityAuthority (which copies may be redacted as necessary to comply with any confidentiality or information protection requirements under any applicable Third Party Component Contracts); and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. To the extent practicable, each Party will use Commercially Reasonable Efforts to provide all All such documents or reports described in clause subclause (b) above will be provided to the non-Regulatory Responsible Party at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faith. During the Collaboration Term, to To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Licensed Product or activities under this AgreementAgreement with respect to a Licensed Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party within [***]. In addition, during the Collaboration Term, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Licensed Products.

Meetings and Communications. During the Collaboration Term, each Party will shall keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Shared Global Development Activities activities performed under this Agreement promptly following receipt thereofAgreement. In addition, during the Collaboration Term, to To the extent relating to a Licensed Collaboration Product, the applicable Regulatory Responsible Party will that is the regulatory sponsor or, following the release of headline data of the relevant Clinical Study, the applicant for the Drug Approval Application with respect to such Collaboration Product, shall provide the other Party with: (a) to the extent allowable by Applicable applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe [***] in substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Trials Studies or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory Authority; and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. To the extent practicable, each Party will use Commercially Reasonable Efforts to provide all All such documents or reports described in clause subclause (b) above shall be provided to the non-Regulatory Responsible Party JRDC at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faith. During the Collaboration Term, to To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Licensed Collaboration Product or activities under this AgreementAgreement with respect to a Collaboration Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party within [***]. In addition, during the Collaboration Term, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Licensed Collaboration Products.