Common use of Interactions with Regulatory Authorities Clause in Contracts

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. 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 and solely to the Regeneron Product, Regeneron shall also be permitted to respond directly to such Regulatory Authority if Regeneron’s Regeneron reasonably believes the necessary response includes would include proprietary subject matter regarding RegeneronRxxxxxxxx’s Product that is not to be shared with the SponsorSponsor under this Agreement. 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). Notwithstanding the foregoing, Regeneron shall not be obligated to provide any such proprietary information to a Regulatory Authority in a country that it believes, reasonably and in good faith, presents unreasonable legal or regulatory risk or risk to its Intellectual Property rights.

Interactions with Regulatory Authorities. Regeneron shall Except (a) for approvals and licenses required with respect to the MacroGenics Manufacturing Facility, which will be the responsibility of MacroGenics, or (b) as otherwise provided in the Collaboration Agreement, Incyte will be responsible for the preparation and filing of any Regulatory Documentation, if any, and for all contacts and communications with any Regulatory Authorities with respect to matters specifically relating to the Manufacture of Licensed Product; provided that as set forth in the Collaboration Agreement MacroGenics will continue to be responsible for submissions and interactions with Regulatory Authorities with respect to matters specifically relating to MacroGenics Pipeline Assets. MacroGenics will assist Incyte upon request with any interactions with Regulatory Authorities regarding the Manufacturing Related Activities or Manufacture of the Licensed Compound Bulk Drug Substance. Notwithstanding the foregoing, Incyte will identify, reference and include MacroGenics’ subcontractors in Exhibit A in the Regulatory Documentation. MacroGenics will notify Incyte [***] MacroGenics receives any contact or communication from any Regulatory Authority related in any way to the Manufacturing Related Activities or Manufacture of the Licensed Compound Bulk Drug Substance, or which could be reasonably expected to have a materially adverse effect on the right (but no obligation) Manufacturing Related Activities or Licensed Compound Bulk Drug Substance. MacroGenics 244242908 v3 will provide Incyte with copies of any such correspondence or other communication [***] of such communication by MacroGenics. MacroGenics will consult with Incyte regarding 244242908 v3 the response to any inquiry or observation from any Regulatory Authority relating to the Manufacturing Related Activities or Manufacture of the Licensed Compound Bulk Drug Substance and, except with respect to matters related to the MacroGenics Manufacturing Facility, will allow Incyte, as appropriate, to participate in any discussions between Sponsor further contacts or communications relating to the Manufacturing Related Activities or Manufacture of the Licensed Compound Bulk Drug Substance. MacroGenics will comply with all reasonable requests and comments by Incyte with respect to all contacts and communications with any Regulatory Authority regarding matters related specifically relating in any way to the Regeneron Product in Manufacturing Related Activities or Manufacture of 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 Licensed Compound Bulk Drug Substance. MacroGenics will assist Incyte with drafts of any such discussions. If Sponsor receives any correspondence, comments correspondence or other inquiries from a reports to be submitted to Regulatory Authority that pertain Authorities concerning the Manufacturing Related Activities or Manufacture of the Licensed Compound Bulk Drug Substance, for review prior to the Combination or the Regeneron Productsubmission, 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, Regeneronfaith Incyte’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)comments, and Sponsor will forward such response provide final copies 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)Incyte promptly after submission.

Interactions with Regulatory Authorities. Regeneron Insofar as it relates to the Planned Trials and Licensee Added Trials (if any) where Licensee has confirmed and consented in writing that Duality is the sponsor, Duality shall lead interactions with Regulatory Authorities in the Territory; provided that JSC shall have final decision making authority in relation to such interactions with Regulatory Authorities and Duality shall follow all instructions provided to it by the JSC in this regard and Duality shall provide Licensee with (i) access to or copies of all material written or electronic communication received by Duality or its Affiliates from any Regulatory Authorities in the Territory and in the Retained Territory (if applicable), and (ii) copies of all meeting minutes with any Regulatory Authorities in the Territory and in the Retained Territory (if applicable). In addition, Duality shall provide Licensee with written notice of any scheduled material meeting, conference, or discussion with a Regulatory Authority related to Regulatory Approvals related to the Planned Trials and Licensee Added Trials (if any). Licensee (or its designee) shall have the right to (but no obligationi) to attend and participate in any discussions between Sponsor and any all such meetings with Regulatory Authority regarding matters Authorities related specifically to the Regeneron Product Planned Trials and Licensee Added Trials (if any), and all telephone conferences and preparation meetings of Duality or its Affiliates related to any such meeting, (ii) provide input on the regulatory filings in the Study, and, Territory and in the Retained Territory (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 this impacts the applicable Regulatory Authority, position of Licensee 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 requiredTerritory), and Sponsor will forward such response (iii) have final decision making authority in relation to any unsettled matter between the Regulatory Authority on Regeneron’s behalf. With Parties with respect to any correspondence, comments or other inquiries from a Regulatory Authority regarding a Study that pertain specifically to regulatory filings in 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 SponsorTerritory. Subject to the conditions set forth foregoing, Licensee (and/or its Affiliates, or Sublicensees as applicable) shall have the sole right to conduct all communications with Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to the Licensed Compound and ADC Licensed Products in the foregoing sentenceTerritory, if Regeneron elects to respond directly to such Regulatory Authorityincluding in respect of the Licensee Added Trials where Licensee (or its Affiliates or Sublicensees, Regeneron shall be responsible for providing its response within as applicable) is the deadline prescribed by such Regulatory Authority sponsor (if noneany). Without limiting the forgoing, Regeneron shall nonetheless provide such response promptlythe Parties agree that they will collaborate with each other as necessary to ensure the successful progression of interactions with Regulatory Authorities with respect to all trials relating to the Licensed Compound and Original ADC Licensed Products in the Territory and in the Retained Territory (to the extent this impacts the position of Licensee in the Territory).

Interactions with Regulatory Authorities. Regeneron Insofar as it relates to the Planned Trials and Original ADC Added Trials (if any) where Licensee has confirmed and consented in writing that Duality is the sponsor, Duality shall lead interactions with Regulatory Authorities in the Territory; provided that JSC shall have final decision making authority in relation to such interactions with Regulatory Authorities and Duality shall follow all instructions provided to it by the JSC in this regard and Duality shall provide Licensee with (i) access to or copies of all material written or electronic communication received by Duality or its Affiliates from any Regulatory Authorities in the Territory and in the Retained Territory (if applicable), and (ii) copies of all meeting minutes with any Regulatory Authorities in the Territory and in the Retained Territory (if applicable). In addition, Duality shall provide Licensee with written notice of any scheduled material meeting, conference, or discussion with a Regulatory Authority related to Regulatory Approvals related to the Planned Trials and Original ADC Added Trials (if any). Licensee (or its designee) shall have the right to (but no obligationi) to attend and participate in any discussions between Sponsor and any all such meetings with Regulatory Authority regarding matters Authorities related specifically to the Regeneron Product Planned Trials, Original ADC Added Trials (if any) and Next Generation Added Trials (if any), and all telephone conferences and preparation meetings of Duality or its Affiliates related to any such meeting, (ii) provide input on the regulatory filings in the Study, and, Territory and in the Retained Territory (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 this impacts the applicable Regulatory Authority, position of Licensee 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 requiredTerritory), and Sponsor will forward such response (iii) have final decision making authority in relation to any unsettled matter between the Regulatory Authority on Regeneron’s behalf. With Parties with respect to any correspondence, comments or other inquiries from a Regulatory Authority regarding a Study that pertain specifically to regulatory filings in 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 SponsorTerritory. Subject to the conditions set forth foregoing, Licensee (and/or its Affiliates, or Sublicensees as applicable) shall have the sole right to conduct all communications with Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to the Licensed Compound and Original ADC Licensed Products and, after Next Generation Option Exercise, all Next Generation Licensed Compound and Next Generation ADC Licensed Products, in the foregoing sentenceTerritory, if Regeneron elects to respond directly to such Regulatory Authorityincluding in respect of the Original ADC Added Trials where Licensee (or its Affiliates or Sublicensees, Regeneron shall be responsible for providing its response within as applicable) is the deadline prescribed by such Regulatory Authority sponsor (if noneany). Without limiting the forgoing, Regeneron shall nonetheless provide such response promptlythe Parties agree that they will collaborate with each other as necessary to ensure the successful progression of interactions with Regulatory Authorities with respect to all trials relating to the Licensed Compound and Original ADC Licensed Products, and/or after Next Generation Option Exercise, all Next Generation Licensed Compound and Next Generation ADC Licensed Product, in the Territory and in the Retained Territory (to the extent this impacts the position of Licensee in the Territory).

Interactions with Regulatory Authorities. Regeneron Kite shall promptly provide Humanigen with a copy of any material notice, inquiry or correspondence that Kite receives from a Regulatory Authority regarding the Study (“Material Regulatory Notice”), including any serious safety matter related to a Party’s Investigational Product or the Combination and any inspection or investigation by a Regulatory Authority. Humanigen shall have the right (but no not the obligation) to provide comments to any response to such Material Regulatory Notice, to the extent such Material Regulatory Notice is related to either the Combination or the Humanigen Investigational Product, and to participate in any discussions between Sponsor and any with a Regulatory Authority regarding matters related specifically relating to the Regeneron Product in the Study, andsuch Material Regulatory Notice, to the extent reasonably practicable, Sponsor shall provide sufficient advance notice (at least five (5) Business Days, unless a shorter response period is required permitted by the applicable such Regulatory Authority. Notwithstanding the aforementioned, 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 if a Material Regulatory Authority that pertain to Notice is directed at the Combination or the Regeneron Humanigen Investigational Product, Sponsor then Humanigen will immediately review and respond to Kite with all necessary information to address the Material Regulatory Notice. Furthermore, without limiting Humanigen’s obligations under Section 2.6(c), Humanigen shall promptly provide such correspondenceKite with a copy of any material notice, comments inquiry 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 correspondence that Humanigen 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 its Affiliate receives from a Regulatory Authority regarding a Study the Humanigen Investigational Product that pertain specifically would reasonably have an impact on the conduct of the Study, including without limitation, any serious safety matter related to the Regeneron Humanigen Investigational Product. In addition to Material Regulatory Notices, Regeneron shall also be permitted to respond directly to such Kite may conduct other meetings with Regulatory Authority if Regeneron’s response includes proprietary subject matter regarding Regeneron’s Product that is not to be shared with the Sponsor. Subject Authorities relating to the conditions set forth Study, and at the JDC’s discretion, invite Humanigen to observe and/or contribute to Kite’s interactions with Regulatory Authorities. The Parties shall keep confidential the nature and substance of such Kite’s discussions with Regulatory Authorities, and any Confidential Information or Joint Confidential Information exchanged in such discussions shall at all times be subject to 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)terms of this Agreement.

Interactions with Regulatory Authorities. Regeneron Insofar as it relates to the Ongoing Trials in the Territory and Licensee Added Trials (if any) where Duality is the sponsor, Duality shall lead interactions with Regulatory Authorities in the Territory; provided that JSC shall have final decision making authority in relation to such interactions with Regulatory Authorities and Duality shall follow all instructions provided to it by the JSC in this regard and shall provide Licensee with (i) access to or copies of all material written or electronic communication received by Duality or its Affiliates from any Regulatory Authorities in the Territory and in the Retained Territory (if applicable), and (ii) copies of all meeting minutes with any Regulatory Authorities in the Territory and in the Retained Territory (if applicable). In addition, Duality shall provide Licensee with written notice of any scheduled material meeting, conference, or discussion with a Regulatory Authority related to Regulatory Approvals related to the Ongoing Trials. Licensee (or its designee) shall have the right to (but no obligationi) to attend and participate in any discussions between Sponsor and any all such meetings with Regulatory Authority regarding matters Authorities related specifically to the Regeneron Product Ongoing Trials), and all telephone conferences and preparation meetings of Duality or its Affiliates related to any such meeting, (ii) provide input on the regulatory filings in the Study, and, Territory and in the Retained Territory (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 this impacts the applicable Regulatory Authority, position of Licensee 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 requiredTerritory), and Sponsor will forward such response (iii) have final decision making authority in relation to any unsettled matter between the Regulatory Authority on Regeneron’s behalf. With Parties with respect to any correspondence, comments or other inquiries from a Regulatory Authority regarding a Study that pertain specifically to regulatory filings in 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 SponsorTerritory. Subject to the conditions set forth foregoing, Licensee (and/or its Affiliates, or Sublicensees as applicable) shall have the sole right to conduct all communications with Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to the Licensed Compound and Licensed Products in the foregoing sentenceTerritory, if Regeneron elects to respond directly to such Regulatory Authorityincluding in respect of the Licensee Added Trials where Licensee (or its Affiliates or Sublicensees, Regeneron shall be responsible for providing its response within as applicable) is the deadline prescribed by such Regulatory Authority sponsor (if noneany). Without limited the forgoing, Regeneron shall nonetheless provide such response promptlythe Parties agree that they will collaborate with each other as necessary to ensure the successful progression of interactions with Regulatory Authorities with respect to all trials relating to the Licensed Compound and Original ADC Licensed Products in the Territory and in the Retained Territory (to the extent this impacts the position of Licensee in the Territory).