Medical and Consumer Inquiries. The JCC shall establish guidelines to handle medical questions or inquiries from consumers relative to Licensed Products.
Medical and Consumer Inquiries. Each Party (through its local Affiliates, as appropriate) shall be entitled to respond to routine medical and consumer inquiries received by it concerning the Products; provided that all such responses shall be in accordance with the approved Product labeling information and, as appropriate, the recommendations of the applicable Joint Country Commercialization Committee, and that all such inquiries and responses shall be shared, as appropriate, with the other Party to the extent not prohibited by applicable Law. Any non-standard inquiries should be directed to the attention of such person[s] as is [are] designated pursuant to Section 4.7(i).
Medical and Consumer Inquiries. Prior to the date of receipt of U.S. Marketing Approval, (a) Regeneron shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding the Product in the Regeneron Field in the U.S. and Japan, and (b) Kiniksa shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding the Product in the Kiniksa Field in the Territory (except as otherwise mutually agreed to by the Parties in connection with Regeneron Exploratory Clinical Studies), in each case ((a) and (b)), in accordance with Applicable Law. After the date of receipt of U.S. Marketing Approval, Kiniksa shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding any Product in the Kiniksa Field in the Territory. If Kiniksa receives any such questions or inquiries about any Product in the U.S. and Japan prior to the date of receipt of U.S. Marketing Approval with respect to the Regeneron Field, then it will refer such questions or inquiries to Regeneron, and Regeneron will be responsible for responding thereto. If Regeneron receives any such questions or inquiries about any Product in the U.S. and Japan prior to the date of receipt of U.S. Marketing Approval in the Kiniksa Field or after the date of receipt of U.S. Marketing Approval in the Territory, then, in each case, it will refer such questions to Kiniksa or its designees, and Kiniksa will be responsible for responding thereto. At all times, Regeneron or its designee shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding any Product in the Retained Field. If, at any time, Kiniksa receives any such questions or inquiries about any Product in the Retained Field, then it will refer such questions to Regeneron or its designee, and Regeneron or its designee will be responsible for responding thereto. Nothing in this Section 7.5 (Medical and Consumer Inquiries) shall be construed to supersede the Pharmacovigilance Agreement and in the event of a conflict between this Section 7.5 (Medical and Consumer Inquiries) and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control.
Medical and Consumer Inquiries. The applicable Joint Country Commercialization Sub-Committee or the JCC in the United States if Regeneron has not exercised its right to Co-Promote in the United States shall delegate responsibility for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding VEGF Products in the applicable country. In the Co-Commercialization Countries and the United States, if not a Co-Commercialization Country, each Party shall refer all such questions about VEGF Products that it receives to the Party or Parties responsible for responding thereto as set forth herein, and each Party shall inform the other Party of any answers given, all in accordance with the laws, regulations and policies of the FDA. In the Co-Commercialization Countries and the United States, if not a Co-Commercialization Country, the Parties shall work together to formulate, and shall mutually agree upon, responses to such inquiries, including the content of any Frequently Asked Questions (FAQs). If appropriate, the Parties shall establish a centralized database to document and track medical inquiries. If Regeneron receives any questions about VEGF Products in a country other than the Co-Commercialization Countries or the United States, if not a Co-Commercialization Country, Regeneron shall refer all such questions to Aventis and Aventis shall be responsible for responding thereto.
Medical and Consumer Inquiries. Each Party (through its local Affiliates, as appropriate) shall be entitled to respond to routine medical and consumer inquiries received by it concerning the IL-1 Products; provided that all such responses shall be in accordance with the approved IL-1 Product labeling information and, as appropriate, the recommendations of the JOC, and that all such inquiries and responses shall be shared, as appropriate, with the other Party to the extent not prohibited by applicable Law. Any non-standard inquiries should be directed to the attention of such person(s) as is designated pursuant to Section 7.6(a). 6.19
Medical and Consumer Inquiries. The JCC shall establish guidelines to handle medical questions or inquiries from healthcare professionals, paramedical professionals and consumers related to the Product in the Field in the Territory, and, upon ZLAB’s request and at ZLAB’s expense, Regeneron shall provide training to ZLAB employees with respect to such guidelines; provided that, in Regeneron’s sole discretion, it shall have the right to provide such training to a subset of ZLAB employees that are responsible for training other ZLAB employees and Subcontractors responsible for handling such medical questions or inquiries. To the extent such a question or inquiry is within the scope of the guidelines established by the JCC, ZLAB shall be responsible, [n accordance with such guidelines, for responding to such question or inquiry, and ZLAB shall promptly provide Regeneron a copy of such question or inquiry, as well as ZLAB’s response thereto (including, in each case, a detailed written summary thereof in English). If such a question or inquiry is not within the scope of the guidelines established by the JCC, ZLAB shall promptly provide Regeneron a copy of such question or inquiry, as well as ZLAB’s proposed response thereto (including, in each case, an English translation if such copy or response is not in English), and Regeneron will provide instructions or guidelines for responding to such question or inquiry. ZLAB shall be responsible, in accordance with such instructions or guidelines, for responding to such question or inquiry. If Regeneron receives questions about the Product in the Field in the Territory, it shall refer such questions to ZLAB, and ZLAB shall be responsible for responding thereto in accordance with the foregoing. If ZLAB receives a question about the Product in the ROW or outside the Field in the Territory, it shall refer such questions to Regeneron, and Regeneron shall be responsible for responding thereto.
Medical and Consumer Inquiries. Company shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding Licensed Products in the Field in the Territory. The Parties will work together to formulate responses to the major inquiries, which shall be used, if possible, by Company in the Territory and Regeneron in the Excluded Territory. If Regeneron receives questions about Licensed Products in the Field in a country in the Territory, it shall refer such questions to Company, and Company shall be responsible for responding thereto. If Company receives a question about Regeneron Products in the Field in a country in the Excluded Territory (or about any Regeneron Product outside the Field), it shall refer such questions to Regeneron, and Regeneron shall be responsible for responding thereto.
Medical and Consumer Inquiries. Prior to the Regulatory Transfer Date, TBIL shall be responsible for, and, after the Regulatory Transfer Date, Takeda shall be responsible for, responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding the Product in the Field in the Territory. Prior to the Regulatory Transfer Date, if Takeda receives questions related to such Product, and after the Regulatory Transfer Date, if TBIL receives questions related to such Product, Takeda and TBIL, respectively shall, promptly (but in no event later than [***] Business Days from the receipt of such questions) refer such questions to the other Party without responding to such questions itself, and such other Party shall be responsible for responding thereto. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Medical and Consumer Inquiries. If, after the effective date of termination, Takeda receives medical questions or inquiries from members of the medical and paramedical professions or consumers regarding any Product in any Terminated Country, it shall (unless otherwise required by Applicable Law) refer such questions to TBIL (or its Designee), and TBIL (or its Designee) shall be responsible for responding thereto.
Medical and Consumer Inquiries. Subject to the Praluent Transition Services Agreement or Praluent Pharmacovigilance Transition Services Agreement, and except to the extent related to Development responsibilities allocated to a Party pursuant to Article 4, each Party shall have sole responsibility for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding Praluent Products in such Party’s Territory. Subject to the Praluent Pharmacovigilance Transition Services Agreement or Praluent Transition Services Agreement, each Party shall refer to the other Party all such questions or inquiries that it receives about any Praluent Product pertaining to the other Party’s Territory (other than with respect to the Development responsibilities allocated to such first Party pursuant to Article 4) or relating to Development responsibilities allocated to such other Party pursuant to Article 4.
