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. 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. (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.
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 Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission. responsibilities, including without limitation, a global safety database relating to Product.
Regulatory Meetings and Communications. (A) Subject to applicable Law, Xxxxxxx shall be exclusively responsible for conducting meetings and discussions related to Licensed Product with the Regulatory Authorities. Genmab shall have the right to have [***] attend such meetings and discussions (unless Xxxxxxx agrees that more Genmab people may attend) to the extent that they relate or are pertinent to Genmab’s obligations or deliverables under the Development Plan, unless prohibited by such Regulatory Authorities. Xxxxxxx shall give Genmab reasonable advance notice of such activities to permit Genmab to participate. If any Regulatory Authority communicates with Genmab relating to Licensed Product, Genmab shall notify Xxxxxxx and provide a copy to Xxxxxxx of any written communication, or notes of any oral communication, within [***] of such communication’s occurrence. Genmab shall not respond to any such communication unless Xxxxxxx has given its prior written approval to the form and content of such response.
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.
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. (a) Within [***], the RSC has met and agreed upon processes and procedures CERTAIN PORTIONS OF THE EXHIBIT THAT ARE NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED HAVE BEEN REDACTED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED. for sharing information needed to support each Party’s respective regulatory responsibilities, including without limitation, a global safety database relating to Product.
Regulatory Meetings and Communications. 4.6.1 Upon agreement by the JSC, Marinus will participate in substantive discussions around 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.
