Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

Regulatory Activities. Beginning on (a) Unless otherwise agreed in writing by the Effective Date Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the extent UGNX remains the Lead Development Party Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to a particular territory, subject any substantive or material filings to and be made by New River in accordance with the terms and conditions of this Agreement Section 3.3.3(a), including Drug Approval Applications, and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or shall consider in good faith any comments Shire may have filed) all Regulatory Filings with respect to any such filings. New River shall permit Shire access to and grant Shire the Licensed Products right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the Field in order to obtain Marketing Approvals in each country in US Territory. To the Territory and the European Territory (extent that any such data, regulatory filings or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in regulatory communications are held by a timely fashion to requests for data and information from Regulatory Authorities with respect Third Party, then New River shall arrange direct access to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials portions of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect data, regulatory filings or regulatory communications that are relevant to the Core Development Activities (“activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, Approvals and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent interacting with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Governmental Authorities in the US Territory and the European Territory relating to the Licensed Products in the Fieldfor any Unilateral Product being Developed by Shire under Section 3.6.5.

Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) Qilu shall apply for and maintain, at Qilu’s sole cost and expense, all Regulatory Filings with respect Documents relating to the Licensed Products in the Field in order the Territory. All Regulatory Documents relating to obtain Marketing Approvals the Licensed Products in each country the Field in the Territory shall be owned by Qilu and held in Qilu’s name, except for any Regulatory Documents, including any IND or Imported Drug License, that are required under Applicable Laws to be filed in Arbutus’ name, which Regulatory Documents will be owned by Arbutus, but shall be prepared, filed and maintained by Qilu on Arbutus’ behalf (such Regulatory Documents owned by Arbutus, the European “Arbutus Territory (or Regulatory Documents”). Arbutus shall, at the direction of and with the assistance of Qilu, execute any documentation prepared by Qilu necessary to obtain appoint Qilu as Arbutus’ local regulatory agent to perform regulatory actions on its behalf in connection with the European Centralized Approval in the European Core Territory) Arbutus Territory Regulatory Documents. Qilu shall be responsible, at Qilu’s sole cost and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests expense, for data all communications and information from interactions with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory Territory, both prior to and subsequent to receipt of any Regulatory Approvals. At least thirty (30) days in advance of filing any material Regulatory Document relating to a Licensed Product with any Regulatory Authority in the European Territory, including any IND or MAA (or, if a Regulatory Authority requires that a filing be made in a period that does not allow for such thirty (30) day advance review period, then at a mutually agreed upon time in advance of such filing), Qilu shall provide to Arbutus for Arbutus’ review and comment (i) the then-current draft of such Regulatory Document in full in Chinese, (ii) an English translation of the following portions of any such material Regulatory Document: (w) any protocol synopsis included therein; (x) any clinical overview or any clinical summary for the Licensed Compound, including any summaries of clinical safety, biopharmaceutics or efficacy data; (y) any data from any independent nonclinical pharmacology or toxicology studies with the Licensed Compound conducted by Qilu or its Affiliates or Sublicensees; and (cz) meet with officials any data relating to the Manufacture of the Licensed Compound or Licensed Product by or on behalf of Qilu or its Affiliates or Sublicensees, whether in the form of drug substance or drug product (excluding any data relating to any Licensed Compound or Licensed Product Manufactured and supplied by Arbutus under the Clinical Supply Agreement), and (iii) a summary of the other material parts thereof in English (the “Initial Documentation”). Arbutus shall provide its comments to the Initial Documentation in good faith within [***] of receipt thereof, which comments shall include (A) Arbutus’ written consent to the filing of any Arbutus Territory Regulatory Authorities at Documents within the Initial Documentation or (B) if no such times as consent is so included, comments on specific revisions to the Arbutus Territory Regulatory Documents so that consent may be requested by granted. Additionally, if Qilu makes any material changes to any protocol synopsis included in the Initial Documentation or the material parts of such Regulatory Authorities with respect to Document as previously summarized by Qilu in the Core Development Activities (“Regulatory Activities”)Initial Documentation, provided that KHK will have primary responsibility for obtaining, and UGNX then Qilu shall provide all assistance reasonably requested by KHK, Arbutus with an updated version of such Initial Documentation at least three (3) Business Days prior to filing the applicable Regulatory Document. Qilu will consider in relation good faith Arbutus’ comments to Pricing and/or Reimbursement Approvals for the any material Regulatory Documents relating to a Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation Product prior to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All filing such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface Documents with the applicable Regulatory Authority(ies) andAuthorities; provided, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring that no Arbutus Territory Regulatory Document relating to a Licensed Product may be filed in the course Territory without the prior written consent of Arbutus, such consent not to be unreasonably withheld, conditioned or delayed. Within thirty (30) days after the filing of any material Regulatory Document relating to a Licensed Product with any Regulatory Authority in the Territory, Qilu shall provide to Arbutus a complete electronic copy of the Regulatory ActivitiesDocument original as filed in Chinese. In CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, including scheduled UGNX regulatory strategy discussions MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL addition, after receiving Arbutus’ written request, Qilu shall provide to Arbutus, within a reasonable time, an English translation of such Regulatory Document to the extent the original as filed is not written in English and meetings an English translation thereof has not been provided to Arbutus previously, together with an invoice for the cost of translation, and Arbutus shall pay Qilu the amount as invoiced within thirty (30) days after receiving the invoice. Qilu shall notify Arbutus in writing at least ten (10) Business Days in advance of any material meeting with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products Products, and Arbutus shall have the right, but not the obligation, to have a representative of Arbutus accompany Qilu to each such meeting in an observational capacity if such attendance is permitted by the applicable Regulatory Authorities in the FieldTerritory; provided, that, with respect to any meeting with Regulatory Authorities in the Territory pertaining to an Arbutus Territory Regulatory Document, Arbutus’ representative shall have the right to attend such meeting as a representative of the applicant/owner of such Arbutus Territory Regulatory Document, unless Arbutus agrees in writing prior to such meeting that such representative shall be in attendance in an observational capacity only.

Regulatory Activities. Beginning on the Effective Date Everest shall apply for and to the extent UGNX remains the Lead Development Party with respect to a particular territorymaintain, subject to at Everest’s sole cost and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Lawsexpense, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect relating to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from . All Regulatory Authorities with respect Filings relating to the Licensed Products in the Field in the Territory shall be owned by Everest and held in Everest’s (or its Affiliates’ or Sublicensees’, as the European Territorycase may be) name, provided that (a) for any Regulatory Filings, including any Marketing Approval, that are required under applicable Laws in a Region in the Territory to be filed in the name of a local agent, such Regulatory Filings may be filed and held in the name of a local agent designated by Everest; and (cb) meet with officials of for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Regulatory Authorities at such times as may Territory to be requested by filed in Xxxxx’x name, such Regulatory Authorities with respect to Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Core Development Activities (Territory owned by Xxxxx, the “Xxxxx Territory Regulatory ActivitiesFilings”), provided that KHK will have primary responsibility for obtaining, Xxxxx shall promptly transfer and UGNX shall provide assign all assistance reasonably requested Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territoryapplicable Laws. For the avoidance of doubt, UGNX will be responsible during the period that Xxxxx is the owner of any Xxxxx Territory Regulatory Filings, (x) Everest shall have the right to Commercialize the Product; and (y) subject to the terms of Article 8 (Manufacturing and Supply), Xxxxx shall (itself or through its Affiliate or a CMO) continue to Manufacture and supply the Product for obtainingDevelopment and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and KHK will provide all assistance reasonably requested by UGNXsupply of the Product for any Early Access Programs, in relation accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Pricing and/or Reimbursement ApprovalsEverest, if anyincluding by providing documentation or other materials, for that are necessary to enable Everest to Commercialize the Licensed Products in the Field in Territory due to the Profit Share Territory fact that Xxxxx is required under applicable Laws to be the named applicant and owner of Regulatory Filings relating thereto. Xxxxx shall, at the direction of and with the assistance of Everest, execute any documentation prepared by Everest necessary to appoint Everest, its Affiliates, or Sublicensees as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with such activities will be shared equally (50/50). All such the Xxxxx Territory Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the FieldFilings.

Regulatory Activities. Beginning on The Marketing Authorization Holder for the Effective Date Product in the Territory shall initially be Aquestive and will, if and to the extent UGNX remains legally permissible, be transferred and continue to be held in Haisco’s name. Haisco shall be responsible for preparing and filing all regulatory applications and documents in the Lead Development Party with respect Territory. Haisco shall be solely responsible for the conduct of, have sole right to a particular territoryconduct, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) shall use Commercially Reasonable Efforts to file (to, in consultation with Aquestive, conduct: all Development activities in connection with or have filed) as a condition of seeking or obtaining and maintaining Regulatory Approval of the Product in the Territory, including without limitation, preparing and filing all regulatory applications and documents in the Territory, the meetings with Regulatory Filings with respect Authorities in the Territory, the submission and maintenance of each Regulatory Approval Application and preparation and submission of any supplements thereto, conducting periodic safety reviews, all submissions to the Licensed Products Regulatory Authorities in the Field in order to obtain Marketing Approvals in each country in Territory, any post-marketing obligations required by the Territory Regulatory Authorities, and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) development and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in implementation of a timely fashion to requests for data and information from Regulatory Authorities with respect pharmacovigilance program specific to the Licensed Products Product in the Field in the Territory in compliance with all Applicable Law. Haisco shall be responsible and the European Territory; and pay for one hundred percent (c100%) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), costs and expenses incurred in connection therewith unless otherwise specifically provided that KHK will have primary responsibility for obtainingin this Agreement, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals reimburse Aquestive as applicable for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the any costs incurred by UGNX Aquestive therewith, including but not limited to regulatory related fees, annual product fees, and establishment fees. Haisco shall designate a regulatory liaison to report to the Steering Committee on the status of regulatory activities, including material communications with all Regulatory Authorities in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated Territory, on an as-needed basis as determined by the JSC Steering Committee. At no cost to Aquestive, Haisco shall provide Aquestive with a copy of its annual report in accordance with Article 3. Without limiting the applicability of the foregoing English for safety and the remainder of this Article 5, UGNX shall interface Adverse Events filed with the applicable Regulatory Authority(iesAuthority, on an annual basis; provided that: (i) andAquestive and Haisco shall have entered into a pharmacovigilance agreement in form and substance mutually agreed to in writing by Aquestive and Haisco; and (ii) Aquestive shall provide Haisco with a copy of equivalent reports for safety and Adverse Events filed with the applicable Regulatory Authority outside the Territory in English, through on an annual basis. Haisco shall file each Regulatory Approval Application based on the JDCclinical studies required by the applicable Regulatory Authority in accordance with Applicable Law. Haisco shall provide the Steering Committee with reasonable advance notice of Haisco’s intent to file any Regulatory Approvals for the Product. At Haisco’s written request, shall keep KHK reasonably informed of all material events and developments occurring or if a Regulatory Authority in the course of Territory requires in writing, in connection with the Regulatory ActivitiesApproval or Regulatory Approval Application for the Product in the Territory additional pre- clinical, non-clinical, clinical, and CMC Data beyond the data transferred by Aquestive pursuant to Section 4, Aquestive shall undertake defined regulatory activities within the timeframe specified by the applicable Regulatory Authority or as otherwise agreed by the Parties in writing, including scheduled UGNX regulatory strategy discussions and without limitation, conducting additional CMC studies if required by the Regulatory Authority, meetings with Regulatory Authorities and the preparation and submission of each Regulatory Approval Application for the Product in the Territory Territory; provided, that: (a) Aquestive will provide Haisco with reasonable cost estimates and the European Territory relating parties mutually agree in writing to execute a Statement of Work for these activities prior to the Licensed Products commencement of such work; and (b) subject to the foregoing, Haisco will pay Aquestive for the conduct of such activities in accordance with the Fieldapplicable Statement of Work.

Regulatory Activities. Beginning on (a) Unless otherwise agreed in writing by the Effective Date Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the extent UGNX remains the Lead Development Party Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to a particular territory, subject any substantive or material filings to and be made by New River in accordance with the terms and conditions of this Agreement Section 3.3.3(a), including Drug Approval Applications, and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or shall consider in good faith any comments Shire may have filed) all Regulatory Filings with respect to any such filings. New River shall permit Shire access to and grant Shire the Licensed Products right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the Field in order to obtain Marketing Approvals in each country in US Territory or ROW Territory. To the Territory and the European Territory (extent that any such data, regulatory filings or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in regulatory communications are held by a timely fashion to requests for data and information from Regulatory Authorities with respect Third Party, then New River shall arrange direct access to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials portions of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect data, regulatory filings or regulatory communications that are relevant to the Core Development Activities (“activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, Approvals and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent interacting with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Governmental Authorities in the US Territory and the European Territory relating to the Licensed Products in the Fieldfor any Unilateral Product being Developed by Shire under Section 3.5.5.

Regulatory Activities. Beginning on the Effective Date Qilu shall apply for and to the extent UGNX remains the Lead Development Party with respect to a particular territorymaintain, subject to at Qilu’s sole cost and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Lawsexpense, UGNXall Approvals, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all including Regulatory Filings with respect Approvals, relating to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory Compound and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory Territory, and all such Approvals shall be in Qilu’s name except for any Imported Drug License that is required under Applicable Laws to be filed in Sesen’s name. Qilu shall be responsible for the European Territory; preparation of all Regulatory Materials and (c) meet all communications and interactions with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, Licensed Compound and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance , both prior to and subsequent to receipt of doubtany Regulatory Approvals, UGNX will be responsible provided that Qilu shall provide prior written notice and copies of all proposed Regulatory Materials, including any IND or MAA, [***] (or such less times if [***] is not practicable, but not less than [***])[***] in advance of filing for obtainingSesen’s review and comment, and KHK Qilu will consider in good faith Sesen’s comments to such Regulatory Materials prior to filing such Regulatory Materials with the applicable Regulatory Authorities. Sesen shall provide all reasonable assistance reasonably requested by UGNXQilu with respect to such Regulatory Materials, subject to Section 4.8. All Regulatory Materials and Regulatory Approvals in Qilu’s name shall be owned solely by Qilu. Upon the request by a Regulatory Authority or Governmental Authority in the Territory to Qilu for any information or materials relating to the Licensed Compound or Licensed Products that have not already been provided to Qilu under the terms of this Agreement, Sesen shall promptly provide to Qilu such information or materials to the extent that such information or materials are in Sesen’s possession, readily available and within Sesen’s Control, or can be obtained with reasonable efforts from its contract manufacturers. Qilu shall (a) promptly provide Sesen with an electronic copy of all material Regulatory Materials and material correspondence with Regulatory Authorities or Governmental Authorities, including any IND or MAA, and (b) upon the request of Sesen, provide Sesen with a written summary in English of the Regulatory Materials and correspondence with Regulatory Authorities and Governmental Authorities, in relation each case by or on behalf of Qilu or its permitted Sublicensees with respect to Pricing and/or Reimbursement Approvals, if any, for the Development of the Licensed Compound and Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development ActivitiesTerritory. However, it being understood that the costs incurred by UGNX in connection with such activities will Qilu shall not be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course obligated to provide copies of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions Materials and meetings correspondence with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the FieldGovernmental Authorities except as required under this Agreement.

Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) Ocumension will use Commercially Reasonable Efforts to file (or have filed) all obtain Regulatory Filings with respect to Approvals for the Licensed Products in Product from the Field in order to obtain Marketing Approvals in each country NMPA and other Regulatory Authorities in the Territory for diabetic macular edema with an Approved Label. To the extent permitted by Applicable Law and without prejudice to Section 10.5(c), Ocumension or its designee shall own all Regulatory Materials and Regulatory Approvals of the European Territory (or to obtain the European Centralized Approval Product in the European Core TerritoryTerritory during the Term, and shall use Commercially Reasonable Efforts to maintain such Regulatory Approvals during the Term where obtained (and, for clarity, after termination of this Agreement for period of no more than twelve (12) months, shall take such actions reasonably required to maintain such Regulatory Approvals required to be transferred to Alimera pursuant to Section 10.5(c) until transferred to Alimera pursuant to Section 10.5(c)). Ocumension will notify Alimera in writing at least six (6) months in advance before abandoning any Regulatory Approval, and in order to obtain Pricing and/or Reimbursement Approvals upon request by Alimera, shall reasonably cooperate in the Profit Share Territoryassignment of such Regulatory Approval to Alimera or a designated entity; (b) respond in a timely fashion provided, however, that Alimera shall be solely responsible for costs and expenses relating to requests the foregoing. Ocumension shall be responsible for data the preparation of all Regulatory Materials and information from all communications and interactions with Regulatory Authorities with respect to the Licensed Products Product in the Field in the Territory Territory, both prior to and the European Territory; subsequent to receipt of Regulatory Approval, and (c) meet with officials of the Regulatory Authorities at such times as may be Alimera shall provide reasonable assistance requested by such Regulatory Authorities Ocumension with respect to thereto. Upon the Core Development Activities (“request by a Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities Authority in the Territory and the European Territory to Ocumension for any information or materials relating to the Licensed Products Product that have not already been provided to Ocumension under the terms of this Agreement, Alimera shall promptly provide to Ocumension such information and materials to the extent that such information or materials are in the FieldAlimera’s or its Affiliates’ possession, readily available or within Alimera’s or its Affiliates’ Control.

Regulatory Activities. Beginning on 3.3.1 Prior to the Effective Date Expiration of the Review Period. Prior to the expiration of the Review Period, VALEANT (or its designated Affiliate) will continue to hold and maintain all Regulatory Approvals and other filings with Regulatory Authorities for the Products and Additional Products; provided, however, that VALEANT shall, as directed by the Joint Steering Committee, take all reasonable actions to make available to GSK the benefits of such Regulatory Approvals to the extent UGNX remains required by GSK in connection with its activities under this Agreement. Further, prior to the Lead Development Party with respect to a particular territoryexpiration of the Review Period, subject to VALEANT will be responsible for filing and in accordance obtaining XXXx with the terms Regulatory Authorities for the development, use and conditions commercialization of this Agreement Products and Additional Products in the requirements of Applicable LawsTerritory, UGNXas directed by the Joint PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION (THE "COMMISSION"). THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS ("***"), shall: (a) use AND THE OMITTED TEXT HAS BEEN FILED SEPARATELY WITH THE COMMISSION. Steering Committee and using Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at seek such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50)approvals. All such Regulatory Activities activity shall be done in full consultation with the Joint Steering Committee. All such filings will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course name of VALEANT, except where otherwise required by applicable Law in any country within the Territory. With respect to any Regulatory ActivitiesApproval maintained by VALEANT as provided herein or any MAA to be filed by VALEANT as provided herein, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.VALEANT shall provide GSK with:

Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file BMS (or its Affiliates or other designees) shall have filedthe sole right to (i) all prepare, obtain, and maintain INDs, Drug Approval Applications, Regulatory Filings with respect to the Approvals and other regulatory submissions and applications for Licensed Compounds and Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (including as a single agent, for combination use or to obtain the European Centralized Approval in the European Core Territoryotherwise) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and (including the European Territory; setting of the overall regulatory strategy therefor), and (cii) meet conduct communications with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, Licensed Compounds and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products (including as a single agent, for combination use or otherwise) in the Field in the European Territory. For the avoidance of doubtWithout limiting Avidity’s obligations set forth in a Research Plan, UGNX will Avidity shall provide support and assistance to BMS, as may be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNXBMS and subject to Section 7.12 (Cost of Avidity Support Services), in relation to Pricing and/or Reimbursement Approvalspreparing, obtaining and maintaining INDs, Drug Approval Applications and Regulatory Approvals for Licensed Products, and in the activities in support thereof, including (A) providing documents or other materials required by Applicable Law or requested by a Regulatory Authority, (B) otherwise assisting BMS with preparing such Regulatory Documentation and answering questions from Regulatory Authorities (including, if anyrequested by BMS, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and attending meetings with Regulatory Authorities), (C) filing (or using Commercially Reasonable Efforts to cause its contract manufacturers to file) regulatory documentation with Regulatory Authorities such that such documentation may be referenced in Regulatory Documentation submitted by BMS (or its Affiliates or other designees) for Licensed Compounds and Licensed Products if applicable, and (D) providing (and using Commercially Reasonable Efforts to cause its contract manufacturers to provided) CMC and other Manufacturing-related information and assistance. As between the Parties, all Regulatory Documentation (including all Regulatory Approvals) for any Licensed Compound or Licensed Product shall be owned by, and shall be the sole property and held in the Territory and the European Territory relating to the Licensed Products in the Fieldname of, BMS (or its Affiliate or other designee).

Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) 3.1.1. Xxxxxx shall use Commercially Reasonable Efforts to obtain a Marketing Authorisation for the Initial Product, each Elected Additional Product and any New Presentation in each Country. Unless otherwise agreed, the Parties will use Commercially Reasonable Efforts through the JRC to prepare the MAA to file with the EMA for the Initial Product. Xxxxxx shall file such MAA as soon as possible after the transfer of the documents referred to under Section 2.6, but in no event later than [REDACTED: Term], and in Countries where Marketing Authorisations are not granted by the EMA, shall file the applicable MAA(s) within [REDACTED: Term] of the transfer of the documents referred to under Section 2.6. Xxxxxx shall also make Regulatory Filings for any Elected Additional Product and/or New Presentation in the Territory within [REDACTED: Term] of having available the documentation related to such Elected Additional Product and/or New Presentation in the possession of Theratechnologies or Thera Europe (or have filed) subject to same conditions and exclusions as apply to documents as set out in Section 2.6). Xxxxxx shall be responsible for all Regulatory Activities related to the Initial Product, each Elected Additional Product and any New Presentation. Thera Europe will participate in and assist Xxxxxx with all Regulatory Filings with respect to the Licensed Products EMA for the sole purpose of obtaining Marketing Authorisation for the Initial Product. Thera Europe will also assist Xxxxxx with any Regulatory Filing in Countries where Marketing Authorisation is not granted by the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities EMA with respect to the Licensed Products in the Field in the Territory Initial Product, any Elected Additional Product and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be any New Presentation, if reasonably requested by such Xxxxxx (except in respect of obtaining Pricing approval and reimbursement) Xxxxxx shall consult with and provide Thera Europe with an opportunity to review and comment on any proposed Regulatory Authorities Filing with respect to any Product or New Presentation reasonably in advance of its submission and to participate in any communication with the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation Authority according to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European TerritorySection 3.5. For the avoidance of doubt, UGNX will be responsible for obtainingin Countries where the EMA may grant a Marketing Authorisation, and KHK will provide all assistance reasonably requested by UGNX, in relation Xxxxxx shall use the centralized authorization procedure (pursuant to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part requirements of the UGNX Core Development ActivitiesEMA, it being understood that as more fully defined in Regulation (EC) No. 726/2004 and Directive 2004/27/EC, as the costs incurred by UGNX same may be amended from time to time) for making all Regulatory Filings in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability respect of the foregoing and the remainder of this Article 5Initial Product, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Fieldany Elected Additional Product and/or New Presentation.