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

Regulatory Authority Communications Received by a Party. Each Party shall inform the other Party in a timely manner, not to exceed [***], of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (i) raises any material concerns regarding the safety or efficacy of a Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with a Product; (iii) is reasonably likely to lead to a recall or market withdrawal of a Product; or (iv) relates to expedited reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, 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. 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.

Regulatory Authority Communications Received by a Party. Each Party shall inform keep the other Party informed in a timely manner, not to exceed [***]compliant with the reporting requirements of Regulatory Authorities in their respective territories, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (ia) raises any material concerns regarding the safety or efficacy of a Compound or a Product; (iib) indicates or suggests a potential material liability of either Party to Third Parties in connection with a Product; (iiic) is reasonably likely to lead to a recall or market withdrawal of a Product; or (ivd) 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 obtaining or maintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted. The other Each Party will fully shall reasonably cooperate with and assist such the other Party in complying with regulatory obligations and communications, including by providing to such other Party, in a timely manner after a request, such information Information and documentation in the other such Party’s possession as may be necessary or helpful for the such other Party to prepare a response to an inquiry from a Regulatory Authority, and by having no more than two (2) of its employees or representatives (one clinical and one regulatory) participate in any meeting with a Regulatory Authority at such other Party’s reasonable request and expense. Each Party will *** Certain Confidential Information Omitted 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.

Regulatory Authority Communications Received by a Party. Each Party shall inform the other Party in a timely manner, not to exceed [***], of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (ia) raises any material concerns regarding the safety or efficacy of a Product; (iib) indicates or suggests a potential material liability of either Party to Third Parties in connection with a Product; (iiic) is reasonably likely to lead to a recall or market withdrawal of a Product; or (ivd) relates to expedited reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, 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. 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. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Regulatory Authority Communications Received by a Party. Each Party shall inform keep the other Party informed in a timely manner, not compliant with the reporting requirements of Regulatory Authorities in their respective territories (and with respect to exceed [***]the Licensee Japan Development Activities, Licensee shall keep Takeda informed in a timely manner, compliant with reporting requirements of the PMDA), of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (ia) raises any material concerns regarding the safety or efficacy of a Compound or a Product; (iib) indicates or suggests a potential material liability of either Party to Third Parties in connection with a Product; (iiic) is reasonably likely to lead to a recall or market withdrawal of a Product; or (ivd) 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 obtaining or maintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted. The other Each Party will fully shall reasonably cooperate with and assist such the other Party in complying with regulatory obligations and communications, including by providing to such other Party, in a timely manner after a request, such information Information and documentation in the other such Party’s possession as may be necessary or helpful for the such other Party to prepare a response to an inquiry from a Regulatory Authority, and by having no more than two (2) of its employees or representatives participate in any meeting with a Regulatory Authority at such other Party’s reasonable request and expense. Each Party will 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.

Regulatory Authority Communications Received by a Party. Each Party shall inform keep the other Party informed in a timely manner, not to exceed [***], manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (i) raises any material concerns regarding the safety or efficacy of a the Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with a the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of a the Product; or (iv) relates to expedited and periodic reports of adverse events with respect to a the Product, or Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approval or the continued Commercialization of a the Product, as then conducted. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, 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. 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.