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. (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.
(ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, to the extent Ablynx has advance knowledge, of (a) any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer.
(iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within […***…], or such other longer period of time as is mutually agreed to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than such […***…] period, Ablynx sha...
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. 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. Affimed shall be responsible for engaging, interfacing, corresponding or meeting with any Regulatory Authority regarding Combination Therapy in the Territory. Affimed shall notify Artiva of any scheduled meeting or conference with any Regulatory Authority that relates to the Combination Therapy reasonably in advance of such meeting and shall provide Artiva with any material documentation prepared for such meeting or conference prior to such meeting or conference (except to the extent solely relating to the Affimed Product). In addition, Affimed shall promptly notify Artiva of any Regulatory Authority meetings or inspections, or any other events potentially impacting regulatory status of the Combination Therapy Trial or the Artiva Product promptly after Affimed becomes aware of such. Artiva shall have the right (but not the obligation) to have a reasonable number of its personnel attend and participate in any such meetings, conferences and inspections, to the extent permitted by Applicable Laws and to the extent they do not solely relate to the Affimed Product. Affimed shall (i) without undue delay provide Artiva with copies of all correspondence to or from, and minutes of material meetings (including, for clarity, telephone conferences) with, any Regulatory Authority relating to Development of the Combination Therapy, (ii) allow Artiva to review and provide comments on any correspondence to Regulatory Authority prior to submission, and (iii) consider Xxxxxx’s comments to such correspondence in good faith.
Interactions with Regulatory Authorities. Except as set forth in Section 8.7 or for approvals and licenses required with respect to the Facilities which will be the responsibility of Hovione and, except for any portion of the CMC Documentation to be prepared by Hovione as part of Development Services, Client will be responsible for the preparation and filing of Regulatory Filings, if any, and for all contacts and communications with any Regulatory Authorities with respect to matters specifically relating to Product, and Hovione will have no such contact or communication with any Regulatory Authority without the prior written consent of Client. Hovione will notify Client promptly (and in no event later than *) after Hovione receives any communication from any Regulatory Authority related in any way to the Development Services or Manufacturing Services of Product. Hovione will provide Client with copies of any such correspondence or other communication within * of receipt of such communication by Hovione. Hovione will use commercially reasonable efforts to consult with Client regarding the response to any inquiry or observation from any Regulatory Authority relating to Product and, except with respect to matters related to the Facilities, will allow Client, at its discretion, to participate in any further contacts or communications relating to Product. Hovione will comply with all reasonable requests and comments by Client with respect to all contacts and communications with any Regulatory Authority relating in any way to the Development Services or the Manufacturing Services provided however, that such participation will not prohibit Hovione from responding directly to any Regulatory Authority as required by Applicable Law. Hovione will provide Client with drafts of any correspondence or other reports to be submitted to Regulatory Authorities concerning the Development Services or the Manufacturing Services for review prior to submission, will consider in good faith Client’s comments, and will provide final copies to Client promptly after submission. All documents provided to Client under this Section 8.9 may be redacted to remove confidential information of Third Parties.
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.
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.
