Common use of Other Regulatory Obligations Clause in Contracts

Other Regulatory Obligations. (a) Auxilium shall comply with all pharmacovigilance obligations imposed by Applicable Law in relation to the Product. Each Party shall keep the other informed in a timely manner of any Information that such Party receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) reasonably indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product in any jurisdiction; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product in the Field in the Auxilium Territory. (b) Each Party shall fully cooperate with and assist the other Party in complying with any regulatory obligations with respect to the Product in the Auxilium Territory. (c) Prior to the completion of the transfer of the Product Marketing Authorization to Auxilium, Auxilium shall not communicate with any Regulatory Authority in the Auxilium Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS. Following the completion of transfer of the Product Marketing Authorization to Auxilium, (i) Auxilium’s communications with Regulatory Authorities in the Auxilium Territory regarding the Product shall comply with Section 5.2(c) and Section 5.3(a), and (ii) except to the extent required by Applicable Law, VIVUS shall not communicate with any Regulatory Authority in the Auxilium Territory regarding any Product unless explicitly requested or permitted in writing to do so by Auxilium. Except to the extent required by Applicable Law, in no event shall Auxilium communicate with any Regulatory Authority in the VIVUS Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS.

Other Regulatory Obligations. (a) Auxilium Licensee shall comply with all pharmacovigilance obligations imposed by Applicable Law in relation to the Product. Each Party shall keep the other informed in a timely manner of any Information that such Party receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) reasonably indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product in any jurisdiction; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product in the Field in the Auxilium Licensee Territory. (b) Each Party shall fully cooperate with and assist the other Party in complying with any regulatory obligations with respect to the Product Product, or the manufacturing thereof, in the Auxilium Licensee Territory. (c) Prior to the completion of the transfer of the Product Marketing Authorization to AuxiliumLicensee, Auxilium Licensee shall not communicate with any Regulatory Authority in the Auxilium Licensee Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS. Following the completion of transfer of the Product Marketing Authorization to AuxiliumLicensee, (i) AuxiliumLicensee’s communications with Regulatory Authorities in the Auxilium Licensee Territory regarding the Product shall comply with Section 5.2(c‎5.2(c) and Section 5.3(a‎5.3‎(a), and (ii) except to the extent required by Applicable Law, VIVUS shall not communicate with any Regulatory Authority in the Auxilium Licensee Territory regarding any Product unless explicitly requested or permitted in writing to do so by AuxiliumLicensee. Except to the extent required by Applicable Law, in no event shall Auxilium Licensee communicate with any Regulatory Authority in the VIVUS Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS.

Other Regulatory Obligations. (a) Auxilium Licensee shall comply with all pharmacovigilance obligations imposed by Applicable Law in relation to the Product. Each Party shall keep the other informed in a timely manner of any Information that such Party receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) reasonably indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product in any jurisdiction; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product in the Field in the Auxilium Licensee Territory. (b) Each Party shall fully cooperate with and assist the other Party in complying with any regulatory obligations with respect to the Product Product, or the manufacturing thereof, in the Auxilium Licensee Territory. (c) Prior to the completion of the transfer of the Product Marketing Authorization to AuxiliumLicensee, Auxilium Licensee shall not communicate with any Regulatory Authority in the Auxilium Licensee Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS. Following the completion of transfer of the Product Marketing Authorization to AuxiliumLicensee, (i) AuxiliumLicensee’s communications with Regulatory Authorities in the Auxilium Licensee Territory regarding the Product shall comply with Section 5.2(c) and Section 5.3(a), and (ii) except to the extent required by Applicable Law, VIVUS shall not communicate with any Regulatory Authority in the Auxilium Licensee Territory regarding any Product unless explicitly requested or permitted in writing to do so by AuxiliumLicensee. Except to the extent required by Applicable Law, in no event shall Auxilium Licensee communicate with any Regulatory Authority in the VIVUS Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS.

Other Regulatory Obligations. (a) Auxilium Menarini shall comply with all pharmacovigilance obligations imposed by the Applicable Law in relation to the Product. Each Party Menarini shall keep the other informed VIVUS informed, in a timely manner consistent with Applicable Laws governing adverse event reporting obligations and the pharmacovigilance reporting requirements to Regulatory Authorities in the Menarini Territory, of any Information that such Party Menarini receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) reasonably indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product in any jurisdictionProduct; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product in Product. Menarini shall provide VIVUS with drafts of all pharmacovigilance reports to the Field in Regulatory Authorities and shall not submit such reports before VIVUS has reviewed and been provided a reasonably opportunity to comment on such reports and discuss such reports with Menarini. Failure by Menarini to comply with the Auxilium Territoryprovisions of this Section shall be deemed to be a material breach of this Agreement, giving rise to VIVUS’s right to terminate this Agreement pursuant to Section 12.2(a). (b) Each Party shall fully cooperate with and assist the other Party in complying with any regulatory obligations with respect to the Product in the Auxilium Menarini Territory. Without limiting the foregoing, if a Party receives an inquiry from a Regulatory Authority relating to the Product and such Party is responsible for communications with such Regulatory Authority (as described in Section 5.1 and Section 5.2(c)), the other Party shall provide to such responsible Party upon request, within *** (or sooner if reasonably required for the responsible Party to meet a deadline set by the relevant Regulatory Authority or by Applicable Law), such information and documentation in its possession as may be necessary or helpful to prepare a response to such inquiry. (c) Prior to the completion of the transfer of the Product Marketing Authorization to AuxiliumMenarini, Auxilium Menarini shall not communicate with any Regulatory Authority in the Auxilium Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUS. Following the completion of transfer of the Product Marketing Authorization to AuxiliumMenarini, (i) AuxiliumMenarini’s communications with Regulatory Authorities in the Auxilium Territory regarding the Product shall comply with Section 5.2(c) and 5.1(d), Section 5.3(a5.2(a), and (ii) except to the extent required by Applicable Law, VIVUS shall not communicate with any Regulatory Authority in the Auxilium Territory regarding any Product unless explicitly requested or permitted in writing to do so by Auxilium. Except to the extent required by Applicable Law, in no event shall Auxilium communicate with any Regulatory Authority in the VIVUS Territory regarding any Product unless explicitly requested or permitted in writing to do so by VIVUSSection 5.2(b).