Common use of Regulatory Meetings and Communications Clause in Contracts

Regulatory Meetings and Communications. FALK shall be responsible for conducting all meetings and discussionx xxd routine telephone communications with the EMEA or other Regulatory Authority, related to clinical studies, Drug Approval Applications and Regulatory Approvals for the Licensed Product in the Field in the Territory; provided that FALK shall use [********************** ***************] to conduct sxxx meetings and discussions to facilitate the Regulatory Approval of the Licensed Product in the Field in the Territory. ALTUS shall assist FALK in these efforts. FALK will keep ALTUS and the Steering Committxx xpprised of all matexxxx communications with such regulatory authorities, and ALTUS or its designee shall be entitled to attend all meetings with Regulatory Authorities. FALK shall [*****************] with respect to the conduct of any inxxxxtions by any Regulatory Authority of FALK's site and facilities related to the Licensed Product, and each Xxxxx shall be given the opportunity to attend such site inspection and the summary, or wrap up, meeting related to the Licensed Product with such regulatory authority at the conclusion of such site inspection. To the extent either Party receives written or material oral communication from any regulatory authority relating to the Licensed Product in the Field in the Territory, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable.

Regulatory Meetings and Communications. FALK shall be responsible for conducting all meetings and discussionx xxd routine telephone communications with the EMEA or other Regulatory Authority, related to clinical studies, Drug Approval Applications and Regulatory Approvals for the Licensed Product in the Field in the Territory; provided that FALK shall use [********************** ***************] Commercially Reasonable and Diligent Efforts to conduct sxxx conduxx xuch meetings and discussions to facilitate the Regulatory Approval of the Licensed Product in the Field in the Territory. ALTUS shall assist FALK in these efforts. FALK will keep ALTUS and the Steering Committxx xpprised of all matexxxx communications with such regulatory authorities, and ALTUS or its designee shall be entitled to attend all meetings with Regulatory Authorities. FALK shall [*****************] with respect to the conduct of any inxxxxtions by any Regulatory Authority of FALK's site and facilities related to the Licensed Product, and each Xxxxx shall be given the opportunity to attend such site inspection and the summary, or wrap up, meeting related to the Licensed Product with such regulatory authority at the conclusion of such site inspection. To the extent either Party receives written or material oral communication from any regulatory authority relating to the Licensed Product in the Field in the Territory, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable.

Regulatory Meetings and Communications. FALK shall (a) The Party primarily responsible for conducting a Clinical Trial hereunder will be responsible for conducting meetings and discussions, and routine telephone communications with the FDA related to such Clinical Trial. To the extent practical, a reasonable number of representatives of the other Party will be given the opportunity to participate in substantive discussions and meetings with the FDA which relate to such Clinical Trial. The Party primarily responsible will have decision making authority regarding the number of, and which, representatives of the other Party may attend such meetings, but in any case at least one representative of the other Party may participate. The other Party will have the right to give input and comments to pre-meeting documents and packages that are prepared for FDA meetings regarding Clinical Trials. (b) Genentech will be solely responsible for conducting all meetings and discussionx xxd routine telephone communications discussions with the EMEA or other Regulatory Authority, related to clinical studies, Drug Approval Applications Agencies regarding BLAs and Regulatory Approvals for the Licensed Product in the Field NDAs in the Territory; provided that FALK shall use [********************** ***************] , including without limitation all pre-BLA meetings held with the FDA. Dendreon may participate in such discussions and meetings with the FDA to conduct sxxx meetings and the extent described in 2.18.4(a) above. Dendreon will not have the right to participate, however, in discussions to facilitate the Regulatory Approval of the Licensed Product in the Field in the Territory. ALTUS shall assist FALK in these efforts. FALK will keep ALTUS and the Steering Committxx xpprised of all matexxxx communications with such regulatory authorities, and ALTUS or its designee shall be entitled to attend all meetings with Regulatory AuthoritiesAgencies regarding Licensed Product being developed or sold by Genentech in the Territory outside the United States. FALK shall [*****************] with respect (c) Notwithstanding Section 2.18.4(a) and (b) above, the primarily responsible Party will not be obligated to permit representatives of the conduct of other Party to attend any inxxxxtions Regulatory Agency meetings related specifically to an inspection at such Party's premises by any Regulatory Authority of FALK's site and facilities related to the Licensed Product, and each Xxxxx shall be given the opportunity to attend such site inspection and the summary, or wrap up, meeting related to the Licensed Product with such regulatory authority at the conclusion of such site inspectionAgency. (d) To the extent either Party receives written written, or material oral communication from any regulatory authority the FDA relating to the a Licensed Product in the Field in the TerritoryProduct, the Party receiving such communication shall notify the other Party of the substance of the communication and provide a copy of any written communication as soon as reasonably practicable.