Interactions with Regulatory Authorities. Regeneron shall have the right (but no obligation) to participate in any discussions between Sponsor and any Regulatory Authority regarding matters related specifically to the Regeneron Product in the Study, and, to the extent reasonably practicable, Sponsor shall provide sufficient advance notice (at least five (5) Business Days, unless a shorter response period is required by the applicable Regulatory Authority, in which case such notice shall be provided to Regeneron as soon as reasonably practicable) to Regeneron of any such discussions. If Sponsor receives any correspondence, comments or other inquiries from a Regulatory Authority that pertain to the Combination or the Regeneron Product, Sponsor shall promptly provide such correspondence, comments or inquiries to Regeneron at least five (5) Business Days before any response is due, unless a shorter response period is required by the applicable Regulatory Authority, in which case such correspondence, comments or inquiries shall be provided to Regeneron as soon as reasonably practicable. For all correspondence, comments or inquiries from a Regulatory Authority that pertain to the Combination, but not solely to the Regeneron Product, Regeneron may provide, and Sponsor will consider in good faith, Regeneron’s reasonable comments provided within such five (5) Business Day (or if applicable, shorter) period. If such correspondence, comments or other inquiries pertain solely to the Regeneron Product, Regeneron will promptly review and respond within five (5) Business Days (or such shorter period as may be required), and Sponsor will forward such response to the Regulatory Authority on Regeneron’s behalf. With respect to any correspondence, comments or other inquiries from a Regulatory Authority regarding a Study that pertain specifically to the Regeneron Product, Regeneron shall also be permitted to respond directly to such Regulatory Authority if Regeneron’s response includes proprietary subject matter regarding Regeneron’s Product that is not to be shared with the Sponsor. Subject to the conditions set forth in the foregoing sentence, if Regeneron elects to respond directly to such Regulatory Authority, Regeneron shall be responsible for providing its response within the deadline prescribed by such Regulatory Authority (if none, Regeneron shall nonetheless provide such response promptly).
Interactions with Regulatory Authorities. AstraZeneca will have the sole right to conduct all communications with the Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to Collaboration mRNA Constructs, Product Candidates, and Products in the Territory.
Interactions with Regulatory Authorities. Other than with respect to the performance of the [***] or as otherwise set forth in Section 4 or Exhibit A, [***] will have the sole right to conduct all communications with the Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings and formal agency/sponsor meetings), including all requests and materials submitted for such, with regard to Collaboration mRNA Constructs, Product Candidates, Elected Candidates and Products in the Territory. 5.4. [***]
Interactions with Regulatory Authorities. Corvus shall promptly provide Genentech with a copy of any material notice, inquiry or correspondence that Corvus (or a Project Participant) receives from a Regulatory Authority regarding the Study (“Material Regulatory Notice”), including any serious safety matter related to a Party’s Molecule or the Combination and any inspection or investigation by a Regulatory Authority. Genentech shall have the right (but not the obligation) to provide comments to any response to such Material Regulatory Notice and to participate in any discussions with a Regulatory Authority to the extent permitted by such Regulatory Authority. Without limiting Genentech’s obligations under Section 2.9, Genentech shall promptly provide Corvus with a copy of any [***].
Interactions with Regulatory Authorities. (a) Novo Nordisk shall provide to Zosano in a timely fashion copies of any subsection of any material regulatory communication or submission in the United States, Europe or Japan to the extent concerning the Zosano Patch Technology.
Interactions with Regulatory Authorities. (i) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities.
Interactions with Regulatory Authorities. Notices, inquiries and correspondences that Syndax (or Project Participants) receive from a Regulatory Authority regarding the Study shall be handled in accordance with Section 10.3, subject to the provisions of this Section. If Syndax receives any comments or other inquiries from a Regulatory Authority regarding the Study that pertain specifically to the Genentech Compound, Syndax shall provide such inquiries to Genentech, and Genentech shall provide its responses to Syndax within the timeline imposed by the Regulatory Authority, and in no event later than *** from the date Genentech receives such inquiries from Syndax. Genentech shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to the Genentech Compound, to the extent permitted by such Regulatory Authority.
Interactions with Regulatory Authorities. (a) Prior to the Regulatory Filing Transfer, POZEN shall serve as the lead party for all interactions with the FDA concerning the Initial Products. POZEN shall be responsible for the preparation of the Regulatory Filings for the Initial Products, and for communicating with the FDA regarding the NDA for the Initial Products and such other Regulatory Filings. POZEN shall keep Licensee informed of the status of the preparation of all Regulatory Filings concerning the Initial Products and the review of such filings by the FDA, and provide to Licensee copies of any written communications received from the FDA concerning the Initial Products within [* * *] Business Day of receiving such communications. POZEN shall provide any written communications prepared with respect to the NDA for the Initial Products, any other Regulatory Filings or any other written communications with any Regulatory Authority that it prepares with respect to the Initial Products to Licensee at least [* * *] Business Days prior to the date on which such written communications would be due to such Regulatory Authority, or such shorter period that corresponds to the response time specified by FDA. Licensee shall have the right to (i) review, comment on and approve any such written communications prepared by POZEN with respect to the Regulatory Filings or any other written communications with any Regulatory Authority with respect to the Initial Products that concern or relate to [* * *], and (ii) with respect to any other written communication not described in clause (i) above, review and comment on any such written communications prepared by POZEN with respect to the Regulatory Filings or any other written communications with any Regulatory Authority with respect to the Initial Products. POZEN shall not send any written communications described in clause (i) in the immediately preceding sentence to any Regulatory Authority without Licensee’s prior approval, provided that if Licensee does not respond within the response time specified above, approval shall be deemed granted. Without limiting the generality of the foregoing, to facilitate the process above, POZEN agrees to include a regulatory professional designated by Licensee in POZEN’s internal review process for regulatory communications.
Interactions with Regulatory Authorities. To the extent possible, Roche shall provide to Aspreva reasonable written notice of all meetings and conference telephone calls with any Regulatory Authority related to the Product in the Field in the Territory, and Aspreva shall have the right to have [ * ] attend each such meeting and [ * ] attend each such call, in each case as silent observers and to the extent permitted by the relevant Regulatory Authority. The JC shall implement policies and procedures for providing to Aspreva a copy of all correspondence or communications, other than Regulatory Filings (which are addressed under Section 5.5(e)), with Regulatory Authorities relating to the Product in the Field in the Territory. If such correspondence or communication requires a response, Aspreva shall prepare a draft response, which draft shall be subject to approval by Roche, and where so approved, filed by Roche. Such draft will be deemed approved by Roche if Roche fails to provide a written modification or comments thereto to Aspreva by the earlier of: (i) [ * ] following Roche's receipt of the response prepared by Aspreva or (ii) [ * ] prior to any deadline for filing the response.
Interactions with Regulatory Authorities. Anchiano will have the sole right to conduct all communications with Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to Compounds and Products in the Territory.
