Common use of Communications with Government Agencies Clause in Contracts

Communications with Government Agencies. Connetics shall have the sole right and responsibility and shall bear all costs related to communications with any government agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. MGI shall promptly notify Connetics of any inquiry or other communication that it receives from the FDA concerning the Product. Connetics shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to any inquiries concerning advertising, detailing or promotional materials. MGI, however, shall be able to communicate with the any such governmental agency regarding the Product if: (a) such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; or (b) MGI, if practical, made a request of such agency to communicate with Connetics instead, and such agency refused such request; provided, however, that before making any communication under this SECTION 7.4, MGI shall give Connetics notice as soon as possible of MGI's intention to make such communications, and Connetics shall be permitted, if practical, to accompany MGI, take part in any such communications and receive copies of all such communications.

Communications with Government Agencies. Connetics shall have the sole right and responsibility and shall bear all costs related to communications with any government agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. MGI shall promptly notify Connetics of any inquiry or other communication that it receives from the FDA concerning the Product. Connetics shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to any inquiries concerning advertising, detailing or promotional materials. MGI, however, shall be able to communicate with the any such governmental agency regarding the Product if: (a) such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; or (b) MGI, if practical, made a request of such agency to communicate with Connetics instead, and such agency refused such request; provided, however, that before making any communication under this SECTION 7.4, MGI shall shall, if practical, give Connetics notice as soon as possible of MGI's intention to make such communications, and Connetics shall be permittedshall, if practical, be permitted to accompany MGI, take part in any such communications and receive copies of all such communications.

Communications with Government Agencies. Connetics shall have the sole right and responsibility and shall bear all costs related to communications with any government agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. MGI shall promptly notify Connetics of any inquiry or other communication that it receives from the FDA concerning the Product. Connetics shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to any inquiries concerning advertising, detailing or promotional materials. MGI, however, shall be able to communicate with the any such governmental agency regarding the Product if: (a) such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; or (b) MGI, if practical, made a request of such agency to communicate with Connetics instead, and such agency refused such request; provided, however, that before making any communication under this SECTION Section 7.4, MGI shall shall, if practical, give Connetics notice as soon as possible of MGI's intention to make such communications, and Connetics shall be permittedshall, if practical, be permitted to accompany MGI, take part in any such communications and receive copies of all such communications.

Communications with Government Agencies. Connetics shall have the sole right and responsibility and shall bear all costs related to communications with any government agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. MGI shall promptly notify Connetics of any inquiry or other communication that it receives from the FDA concerning the Product. Connetics shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to any inquiries concerning advertising, detailing or promotional materials. MGI, however, shall be able to communicate with the any such governmental agency regarding the Product if: (a) such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; or (b) MGI, if practical, made a request of such agency to communicate with Connetics instead, and such agency refused such request; provided, however, that before making any communication under this SECTION Section 7.4, MGI shall give Connetics notice as soon as possible of MGI's intention to make such communications, and Connetics shall be permitted, if practical, to accompany MGI, take part in any such communications and receive copies of all such communications.