Common use of Communications with Regulatory Authorities Clause in Contracts

Communications with Regulatory Authorities. From and after the Effective Date, except as otherwise set forth in this Agreement, Maruishi shall be responsible for all contacts with Regulatory Authorities with respect to Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibility, subject to the terms of this Agreement, to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Use, and (b) all applications to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent requested by Maruishi). Maruishi shall disclose and provide to Cara all regulatory and related development Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications, to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. If any of the above-mentioned regulatory activities are conducted by a Cara licensee or sublicensee, Cara shall exert a reasonable effort to have such licensee and sublicensee provided such information to Cara as above.

Communications with Regulatory Authorities. From (a) All communications with Regulatory Authorities concerning the Products prior to the Closing Date shall be the responsibility of Depomed. Depomed shall consult with Collegium regarding any such communication. Depomed shall, within two Business Days after receipt of any communication from the FDA or from any other Regulatory Authority relating to the Products, forward a copy of the same to Collegium and reasonably respond to all inquiries by Collegium relating thereto. (b) All communications with Regulatory Authorities concerning the Products and arising from Collegium’s Commercialization of the Products from and after the Effective Date, except as otherwise set forth in this Agreement, Maruishi Closing Date shall be responsible for all contacts with Regulatory Authorities with respect to Licensed Products in the Territory within the Field responsibility of Use. Maruishi shall have the responsibilityCollegium, subject to the terms of this Agreement, to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Use, and (b) all applications to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara provided that Depomed shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain communicate with the FDA or any other Regulatory Approvals Authority in the Territory as soon as regarding the Products if such communication is reasonably practicable necessary to comply with the terms of this Agreement or any Legal Requirement or is related to Commercialization activities undertaken by or on behalf of Depomed or the Depomed Sales Force. Certain information in this document has been omitted and feasiblefiled separately with the Securities and Exchange Commission. Cara will use reasonable efforts Confidential treatment has been requested with respect to provide the omitted portions marked [***]. (c) Collegium shall, within two Business Days after receipt of any communication from the FDA or from any other Regulatory Authorities relating to the Products, forward a reasonable level copy of assistance the same to Maruishi in its efforts Depomed and reasonably respond to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territoryall inquiries by Depomed relating thereto. Cara Depomed shall have the right to use request review and approve, with reasonable notice, any such and all Regulatory Communications, Regulatory Approvals, and related regulatory submissions for any of its (or its Affiliates’ documents that pertain to the Product NDAs before they are submitted to FDA or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in by Collegium or Newco. At the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except time of any submission to the extent requested by Maruishi). Maruishi shall disclose and provide to Cara all regulatory and related development Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from FDA or other Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara Collegium shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications, to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. If any copy of the above-mentioned regulatory activities are conducted by a Cara licensee or sublicensee, Cara shall exert a reasonable effort communication to have such licensee and sublicensee provided such information to Cara as aboveDepomed.

Communications with Regulatory Authorities. From and after (a) Except to the Effective Date, except as otherwise extent set forth in this AgreementSection 5.4(b), Maruishi all communications with Government Authorities concerning the Product shall be responsible for the sole responsibility of Depomed. Depomed shall within two (2) business days provide Santarus with copies of all contacts such communications (including summaries of all relevant verbal communications) related to Promotional Materials and Serious Adverse Drug Experiences (except that routine communications as to such matters (e.g., FDA 2253 correspondence) may be forwarded to Santarus within five (5) business days) and shall reasonably respond to all inquiries by Santarus relating thereto. Depomed will reasonably consult with Regulatory Authorities with respect to Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibility, subject Santarus concerning adverse drug reaction reporting to the terms FDA and communications related to Promotional matters with the FDA or other Governmental Authorities that Depomed reasonably considers to be significant to the Product, including regulatory responses to follow up inquiries regarding adverse drug reactions. Depomed will provide to Santarus a copy of this Agreement, all draft responses related to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory such matters as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Usesoon as practicable, and will endeavor to provide such responses at least five (5) business days in advance of their submission (to the extent allowable under Legal Requirements), and will consider in good faith any comments provided to Depomed by Santarus. (b) all applications to obtain Santarus shall not, without the consent of Depomed or unless so required by Legal Requirements, correspond or communicate with the FDA or with any other Governmental Authority, whether within the Territory or otherwise, concerning the Products, or otherwise take any action concerning any Regulatory Approvals in Approval under which the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications Products are sold or any application for Regulatory Approval) in Approval of the Territory and of all responses from Regulatory AuthoritiesProducts; provided that during the Term, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara Santarus shall have the right to comment on all draft regulatory submissionscommunicate with the FDA or any other Governmental Authority regarding the Products if such communication is necessary to comply with the terms of this Agreement or any Legal Requirement (including without limitation state or local Legal Requirements related to marketing activities undertaken by Santarus or the Santarus Sales Force), or if Santarus made a request of such agency to communicate with Depomed instead, and Maruishi such Governmental Authority denied such request (in any such case, Santarus shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory give Depomed notice as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent requested by Maruishi). Maruishi shall disclose and provide to Cara all regulatory and related development Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applicationscommunication and, to the extent needed practicable, Depomed shall be permitted to accompany Santarus, take part in any such communications and receive copies of all such communications). Santarus shall within two (2) business days upon receipt of any communication from the FDA or from any other Governmental Authority relating to the Products, forward a copy of the same to Depomed and reasonably respond to all inquiries by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of UseDepomed relating thereto. If Santarus is required by law to communicate with the FDA or with any other Governmental Authority relating to the Products, then Santarus shall so advise Depomed within two (2) business days and provide Depomed in advance with a copy of any proposed written communication, or a written summary of any proposed oral communication with the above-mentioned regulatory activities are conducted FDA or any other Governmental Authority. Santarus shall comply with any and all reasonable direction of Depomed concerning any meeting or written or oral communication with the FDA or any other Governmental Authority relating to the Product unless otherwise required by a Cara licensee or sublicensee, Cara shall exert a reasonable effort to have such licensee and sublicensee provided such information to Cara as aboveLegal Requirements.

Communications with Regulatory Authorities. From 7.3.1 On a Collaboration Target-by-Collaboration Target basis, (a) Kymera, as Regulatory Lead, with respect to Material Communications with a Regulatory Authority in the Territory, (b) Sanofi, as Regulatory Lead prior to and after during the Effective DateOpt-In Period, except with respect to Material Communications with a Regulatory Authority in the Major Market Countries, as otherwise set forth applicable, will: (a) provide the JSC (or a Committee or Subcommittee to which the JSC has delegated responsibility) for its review and discussion with a brief description in this Agreement, Maruishi shall be responsible for all contacts English of the principal issues raised in each Material Communication with Regulatory Authorities with respect to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead, including any communications with a Regulatory Authority with respect to any audit or inspection of such Party or any of its Affiliates or Subcontractors conducted by a Regulatory Authority and related findings thereunder to the extent such audit or inspection relates to the activities conducted under this Agreement; (b) provide such descriptions of such Material Communications to the JSC as part of the quarterly updates regarding Development and Commercialization activities with respect to such Collaboration Target, if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target (except, solely with respect to the U.S., within [***] after receipt thereof), if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target; (c) allow the other Party a reasonable opportunity to review and comment on such Regulatory Lead’s proposed response to such Material Communication in advance of the Territory within transmission of such response, and the Field of Use. Maruishi shall have Regulatory Lead will reasonably consider all comments timely provided by such other Party in connection therewith; provided that Sanofi will not be obligated to provide Kymera the responsibilityright to review or comment on Sanofi’s proposed response to a Material Communication to a Major Market Country other than the U.S., even during the Opt-In Period; and 7.3.2 subject to the terms Section 7.3.1, Sanofi, as Regulatory Lead, will keep Kymera reasonably informed of this Agreement, to prepare and submit (a) all regulatory filings its progress with Regulatory Authorities in the Territory as needed with respect to conduct its clinical development of Collaboration Candidates and Licensed Products in pursuant to the Territory in Late Development Plan and JSC as part of the Field of Use, quarterly updates regarding Development and (b) all applications Commercialization activities with respect to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory Collaboration Candidates and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent requested by Maruishi). Maruishi shall disclose and provide to Cara all regulatory and related development Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications, to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. If any of the above-mentioned regulatory activities are conducted by a Cara licensee or sublicensee, Cara shall exert a reasonable effort to have such licensee and sublicensee provided such information to Cara as above.

Communications with Regulatory Authorities. From and after (a) Except to the Effective Date, except as otherwise extent set forth in this AgreementSection 5.4(b), Maruishi all communications with Government Authorities concerning the Product shall be responsible for the sole responsibility of Depomed. Depomed shall within two (2) business days provide Santarus with copies of all contacts such communications (including summaries of all relevant verbal communications) related to Promotional Materials and Serious Adverse Drug Experiences (except that routine communications as to such matters (e.g., FDA 2253 correspondence) may be forwarded to Santarus within five (5) business days) and shall reasonably respond to all inquiries by Santarus relating thereto. Depomed will reasonably consult with Regulatory Authorities with respect to Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibility, subject Santarus concerning adverse drug reaction reporting to the terms FDA and communications related to Promotional matters with the FDA or other Governmental Authorities that Depomed reasonably considers to be significant to the Product, including regulatory responses to follow up inquiries regarding adverse drug reactions. Depomed will provide to Santarus a copy of this Agreement, all draft responses related to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory such matters as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Usesoon as practicable, and will endeavor to provide such responses at least five (5) business days in advance of their submission (to the extent allowable under Legal Requirements), and will consider in good faith any comments provided to Depomed by Santarus. (b) all applications to obtain Santarus shall not, without the consent of Depomed or unless so required by Legal Requirements, correspond or communicate with the FDA or with any other Governmental Authority, whether within the Territory or otherwise, concerning the Products, or otherwise take any action concerning any Regulatory Approvals in Approval under which the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications Products are sold or any application for Regulatory Approval) in Approval of the Territory and of all responses from Regulatory AuthoritiesProducts; provided that during the Term, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara Santarus shall have the right to comment on all draft regulatory submissionscommunicate with the FDA or any other Governmental Authority regarding the Products if such communication is necessary to comply with the terms of this Agreement or any Legal Requirement (including without limitation state or local Legal Requirements related to marketing activities undertaken by Santarus or the Santarus Sales Force), or if Santarus made a request of such agency to communicate with Depomed instead, and Maruishi such Governmental Authority denied such request (in any such case, Santarus shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory give Depomed notice as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent requested by Maruishi). Maruishi shall disclose and provide to Cara all regulatory and related development Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applicationscommunication and, to the extent needed by Maruishi for its seeking Regulatory Approval practicable, Depomed shall be permitted to accompany Santarus, take part in any such communications and receive copies of Licensed Product in the Territory in the Field of Use. If any of the above-mentioned regulatory activities are conducted by a Cara licensee or sublicensee, Cara shall exert a reasonable effort to have such licensee and sublicensee provided such information to Cara as above.all such

Communications with Regulatory Authorities. From (a) During the Term, all responses to requests or inquiries of Governmental Authorities and after filings with regulatory bodies concerning the Effective DateProducts shall be the sole responsibility of Somaxon. Partner shall reasonably assist Somaxon with respect to such requests, except as otherwise set forth in inquiries or filings to the extent deemed necessary by Somaxon and solely with respect to Partner’s activities under this Agreement, Maruishi including by providing all information and documentation reasonably requested by Somaxon in connection therewith as soon as is reasonably practicable. Somaxon shall be responsible reimburse Partner for all contacts with Regulatory Authorities with respect to Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibilityreasonable expenses and fees for such cooperation, subject to the terms of this Agreement, to prepare Section 5.7 and submit (a) all regulatory filings with Regulatory Authorities in the Territory as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Use, and (b) all applications to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent requested that Partner is obligated to provide indemnification relating to such situation pursuant to Section 11.1. (b) During the Term, Partner shall promptly notify Somaxon of any information Partner receives regarding any threatened or pending action by Maruishi). Maruishi shall disclose and provide to Cara all any Third Party, regulatory and related development Informationagency or other Governmental Authority which may affect the Products, including Regulatory Authority communicationsbut not limited to any litigation or governmental investigation. To the extent permitted by law, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall Partner will provide to Maruishi Somaxon with copies of all documents received by Partner relating to any of the foregoing. Partner shall, at the request of Somaxon, reasonably cooperate with Somaxon in taking appropriate action. In no event shall Partner itself respond to any such third party, regulatory submissions agency or other Governmental Authority action without the prior written consent of Somaxon unless compelled to do so by law. To the extent permitted by law (including applications for Regulatory Approval) outside the Territory and but not limited to all relevant data protection laws), copies of all responses from Regulatory Authoritiesdocuments to be provided to such third party, all the foregoing regulatory agency or Governmental Authority will be provided to Somaxon in advance, if practicable, or otherwise as soon as is reasonably practicable after delivery to such Third Party, regulatory agency or Governmental Authority. Somaxon shall reimburse Partner for reasonable expenses and fees for such cooperation, subject to Section 5.7 and except to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. Cara shall use reasonable efforts that Partner is obligated to provide Maruishi reasonable advance notice indemnification relating to such situation pursuant to Section 11.1. (c) During the Term, Somaxon shall promptly notify Partner of any meetings information Somaxon receives regarding any threatened or scheduled discussions pending action by any Third Party, regulatory agency or other Governmental Authority with Regulatory Authorities outside respect to Partner’s activities under this Agreement, including but not limited to any litigation or governmental investigation. To the Territory regarding Licensed Productsextent permitted by law, and shall update Maruishi as reasonably requested as to all progress and results Somaxon will provide Partner with copies of all such regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts documents received by Somaxon relating to obtain Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products the foregoing. Somaxon shall, at the request of Partner, reasonably cooperate with Partner in the Territory in the Field of Use taking appropriate action. Partner shall reimburse Somaxon for reasonable expenses and fees for such cooperation, subject to Section 5.7 and except upon termination of this Agreement pursuant to Section12.2. Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications, to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. If any of the above-mentioned regulatory activities are conducted by a Cara licensee or sublicensee, Cara shall exert a reasonable effort that Partner is obligated to have provide indemnification relating to such licensee and sublicensee provided such information situation pursuant to Cara as aboveSection 11.1.