Regulatory Meetings and Communications. (a) For each country in the Territory, unless the Joint Project Team otherwise specifies, the Parties shall be jointly responsible for conducting meetings and discussions related to Licensed Products with the Regulatory Authorities in each country of the Territory. Each Party shall be given the opportunity to have one or more of its representatives participate in all substantive discussions and meetings with Regulatory Authorities which relate to Licensed Products, including, but not limited to, with respect to any Drug Approval Applications.
(b) The Joint Project Team, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to Licensed Product. To the extent either Party receives material written or oral communication from the FDA or any other Regulatory Authority relating to Licensed Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication to the other Party as soon as reasonably practicable.
(c) Within sixty (60) days after the Effective Date, the Parties' respective regulatory affairs or other applicable departments, including the members of the Joint Project Team with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section for sharing of information and adverse event reporting shall be consistent with Article 13.
(d) The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party's site and facilities related to Licensed Products, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to Licensed Products with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party's attendance at such inspections if such attendance would result in...
Regulatory Meetings and Communications. (a) Within [***], the RSC has met and agreed upon processes and procedures for sharing information needed to support each Party’s respective regulatory responsibilities, including without limitation, a global safety database relating to Product.
(b) Immediately after confirmation of any meetings with Regulatory Authorities in OMP Territory or the EU, each Party shall notify the other Party of such meeting and both Parties shall have the right to attend any such meetings with Regulatory Authorities set up by the other Party to ensure that the Product is consistently Prepared for Regulatory Approval. The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party’s or contractor’s site and facilities, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting with a Regulatory Authority at the conclusion of such site inspection. If such attendance would result in the disclosure to the other Party of confidential information or trade secrets unrelated to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering the unrelated subject matter. To the extent either Party receives written or material oral communication from the FDA or any other Regulatory Authority in the EU relating to any activities subject to this Agreement, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable and in no case later than three (3) business days thereafter.
Regulatory Meetings and Communications. The Party that owns any IND or New Product Application shall be primarily responsible for conducting meetings and discussions with the Regulatory Authorities related to the Product, including in relation to any Development under way at the Closing Date including the Ongoing Pivotal Studies, provided that the other Party shall have the right to participate in such meetings and discussions, unless prohibited by such Regulatory Authorities. The Party primarily responsible shall give the other Party reasonable advance notice of such activities to permit that other Party to participate. If the FDA or any other Regulatory Authority communicates with the other Party relating to the Product, the other Party shall notify the Party primarily responsible and provide a copy to that Party of any written communication, or notes of any oral communication, within [***] of such communication’s occurrence. The other Party shall not respond to any such communication unless the Party primarily responsible has given its prior written approval to the form and content of such response. The Parties shall co-operate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party’s site and facilities related to the Product, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to the Product with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party’s attendance at such inspections if such attendance would unavoidably result in the disclosure to the other Party of confidential information or trade secrets unrelated to the Product; provided, that at the option of the other Party, in lieu of such other Party attending the inspection, the Party whose facilities are being inspected will provide a summary of findings to the other Party.
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 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. Notwithstanding any other provision herein, (i) Advaxis shall have the right to participate in and attend any meetings or conferences with the FDA or other Regulatory Authorities relating to the Licensed Products; (ii) OST shall keep Advaxis informed of, the status of the preparation of all Regulatory Filings and other communications with Regulatory Authorities, Regulatory Authority review of any such Regulatory Filings, and all Regulatory Approvals that it obtains with respect to the applicable Licensed Product; and (iii) OST shall provide to Advaxis copies of all final Regulatory Filings it submits promptly after the submission.
Regulatory Meetings and Communications. 4.6.1 NovaMedica shall timely inform the JDC of any material meetings scheduled with the applicable Regulatory Authorities in the Territory relating to the Covered Products and/or Compound as soon as reasonably practicable. NovaMedica shall provide the JDC with a description of the plan or purpose of each such meeting, shall keep the JDC informed regarding the meeting and its results and shall make available to the JDC copies of the relevant correspondence relating to such meeting. Upon decision of the JSC and NovaMedica’s request Lithera will participate in substantive discussions and meetings with Regulatory Authorities in the Territory which relate to the Covered Products and/or Compound, including, but not limited to, with respect to any Drug Approval Applications.
4.6.2 The JDC shall develop processes and procedures for the conduct and reporting to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to the Covered Products and/or Compound.
4.6.3 The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of (a) clinical sites in the Territory at which clinical studies are being conducted on behalf of either Party or (b) NovaMedica’s facilities, in each case to the extent related to the Covered Products and/or Compound, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to the Covered Products and/or Compound with such Regulatory Authority at the conclusion of such site inspection.
Regulatory Meetings and Communications. Alkermes shall be primarily responsible for conducting meetings and discussions related to the Products with the FDA, provided, however, that Cephalon shall have the right to participate in such meetings and discussions. Alkermes shall give Cephalon reasonable advance notice of such activities to permit Cephalon to participate. If Alkermes has substantive written or oral communication with the FDA relating to the Products, Alkermes shall notify Cephalon and provide an advance copy to Cephalon of any such written communication to the FDA at least [**] Business Days, if reasonably possible to do so and otherwise as soon as practicable, prior to such communication’s intended occurrence and a copy to Cephalon of any such written communication from the FDA within [**] Business Days of such communication’s occurrence. Alkermes shall consider in good faith any comments provided by Cephalon regarding any planned communication to the FDA. In the event Cephalon receives any written or oral communication from the FDA relating to the Products, Cephalon shall notify Alkermes and provide a copy to Alkermes of any such written communication within [**] Business Days of such communication’s occurrence. Cephalon shall not respond to any such communication but shall permit Alkermes to respond on Cephalon’s behalf; provided, however, that Cephalon shall have the right to respond to FDA communication to the extent reasonably required to comply with applicable Laws.
Regulatory Meetings and Communications. 3.6.1 Upon decision of the JSC and NovaMedica’s reasonable request Regado will participate in substantive discussions and meetings with Regulatory Authorities in the Territory which relate to the Covered Products and/or Compound, including, but not limited to, with respect to any Drug Approval Applications.
3.6.2 The JDC shall develop processes and procedures for the conduct and reporting to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to the Covered Products and/or Compound.
3.6.3 Within sixty (60) days after the Effective Date, the Parties’ respective regulatory affairs or other applicable departments, including the members of the JDC with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the JDC for sharing information needed to support each Party’s respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Covered Products and/or Compound. The processes and procedures adopted by the JDC under this Section for sharing of information and adverse event reporting shall be consistent with Section 6.
3.6.4 The Parties shall cooperate in good faith with respect to the conduct of any scheduled inspections by any Regulatory Authority of a Party’s site and facilities related to the Covered Products and/or Compound, and each Party shall to the extent practicable be given the opportunity to attend the summary, or wrap up, meeting related to the Covered Products and/or Compound with such Regulatory Authority at the conclusion of such site inspection.
Regulatory Meetings and Communications. (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 discussions with Regulatory Agencies regarding BLAs and NDAs in the Territory, including without limitation all pre-BLA meetings held with the FDA. Dendreon may participate in such discussions and meetings with the FDA to the extent described in 2.18.4(a) above. Dendreon will not have the right to participate, however, in discussions or meetings with Regulatory Agencies regarding Licensed Product being developed or sold by Genentech in the Territory outside the United States.
Regulatory Meetings and Communications. (a) The applicable party shall be responsible for conducting meetings and discussions with a Regulatory Agency related to a regulatory submission for which it is the Lead Regulatory Party. Each party shall be given the opportunity to have one or more of its representatives participate in all substantive discussions and meetings conducted by the other party with the FDA, the EMEA and the CHMP that relate to Licensed Products, including with respect to any INDs and BLAs.
(b) Each party shall timely provide the other party with a copy of any material documents or reports to be filed with the FDA and the EMEA under this Agreement. The JDC shall discuss all such material documents or reports prior to filing. The JDC, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting to the parties of telephone communications and written correspondence with the FDA and the EMEA related to Licensed Products. To the extent either party receives material written or oral communication from the FDA or the EMEA relating to Licensed Products, the party receiving such communication shall notify the other party and provide a copy of any written communication, or notes of any oral communication, to the other party as soon as reasonably practicable.
