Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. Everest shall apply for and maintain, at Everest’s sole cost and expense, all Regulatory Filings relating to the Products in the Field in the Territory. All Regulatory Filings relating to the Products in the Field in the Territory shall be owned by Everest and held in Everest’s (or its Affiliates’ or Sublicensees’, as the case 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 (b) for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory Filings.

Regulatory Activities. Everest shall apply for and maintain(a) As between the Parties, AbbVie, at Everest’s its sole cost and expense, shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other regulatory submissions, and to conduct communications with the Regulatory Authorities, for Discovery T-Cell Receptor Constructs or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). Licensor shall support AbbVie, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the Discovery Research Plan. [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (b) All Regulatory Documentation (including all Regulatory Filings Approvals and Product Labeling) specifically relating to the Discovery T-Cell Receptor Constructs or Licensed Products in the Field in the Territory. All Regulatory Filings relating with respect to the Products in the Field in the Territory shall be owned by Everest by, and held in Everest’s (or its Affiliates’ or Sublicensees’, as shall be the case 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 sole property and held in the name of a local agent of, AbbVie or its designated by Everest; Affiliate, Sublicensee or designee. Licensor shall duly execute and (b) for any Regulatory Filingsdeliver, including any IND or Imported Drug License, that are required under applicable Laws in the Territory cause to be filed in Xxxxx’x nameduly executed and delivered, such Regulatory Filings will instruments and shall do and cause to be owned by Xxxxx but shall be prepared, filed done such acts and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territorythings, including the Manufacture filing of such assignments, agreements, documents, and supply of the Product for any Early Access Programsinstruments, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are as may be necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Affiliatesunder, or Sublicensees as Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf AbbVie may reasonably request in connection with with, or to carry out more effectively the Xxxxx Territory Regulatory Filingspurpose of, or to better assure and confirm unto AbbVie its rights under, this Section.

Regulatory Activities. Everest The Marketing Authorization Holder for the Product in the Territory shall apply for initially be Aquestive and maintainwill, at Everest’s sole cost if and expense, all Regulatory Filings relating to the Products extent legally permissible, be transferred and continue to be held in the Field Haisco’s name. Haisco shall be responsible for preparing and filing all regulatory applications and documents in the Territory. All Haisco shall be solely responsible for the conduct of, have sole right to conduct, and shall use Commercially Reasonable Efforts to, in consultation with Aquestive, conduct: all Development activities in connection with or as a condition of seeking or obtaining and maintaining Regulatory Filings relating 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 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 Products Regulatory Authorities in the Territory, any post-marketing obligations required by the Regulatory Authorities, and the development and implementation of a pharmacovigilance program specific to the Product in the Field in the Territory in compliance with all Applicable Law. Haisco shall be owned responsible and pay for one hundred percent (100%) of the costs and expenses incurred in connection therewith unless otherwise specifically provided for in this Agreement, and shall reimburse Aquestive as applicable for any costs incurred by Everest Aquestive therewith, including but not limited to regulatory related fees, annual product fees, and held 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 Everestthe Territory, on an as-needed basis as determined by the Steering Committee. At no cost to Aquestive, Haisco shall provide Aquestive with a copy of its annual report in English for safety and Adverse Events filed with the applicable Regulatory Authority, on an annual basis; provided that: (i) Aquestive 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, on an annual basis. Haisco shall file each Regulatory Approval Application based on the clinical 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, or its Affiliates’ if a Regulatory Authority in the Territory requires in writing, in connection with the Regulatory Approval or Sublicensees’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 case may be) nameParties in writing, provided that including 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; provided, that: (a) Aquestive will provide Haisco with reasonable cost estimates and the parties mutually agree in writing to execute a Statement of Work for any Regulatory Filings, including any Marketing Approval, that are required under applicable Laws in a Region in these activities prior to the Territory to be filed in the name commencement of a local agent, such Regulatory Filings may be filed and held in the name of a local agent designated by Everestwork; and (b) for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 foregoing, Haisco will pay Aquestive for the conduct of Article 8 (Manufacturing and Supply), Xxxxx shall (itself or through its Affiliate or a CMO) continue to Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, such activities in accordance with the terms applicable Statement of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory FilingsWork.

Regulatory Activities. Everest Qilu shall apply for and maintain, at EverestQilu’s sole cost and expense, all Approvals, including Regulatory Filings Approvals, relating to the Licensed Compound and the Licensed Products in the Field in the 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 preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the Licensed Compound and Licensed Products in the Field in the Territory, both prior to and subsequent to receipt of any Regulatory Approvals, 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 Sesen’s review and comment, and 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 reasonable assistance requested by Qilu 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 each case by or on behalf of Qilu or its permitted Sublicensees with respect to the Development of the Licensed Compound and Licensed Products in the Field in the Territory. All However, Qilu shall not be obligated to provide copies of the Regulatory Filings relating to the Products in the Field in the Territory shall be owned by Everest Materials and held in Everest’s (or its Affiliates’ or Sublicensees’, correspondence with Regulatory Authorities and Governmental Authorities except as the case 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 (b) for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory FilingsAgreement.

Regulatory Activities. Everest (a) 3DMed shall apply for and maintain, at Everest3DMed’s sole cost and expenseexpense and in 3DMed’s name, all Approvals, including Regulatory Filings Approvals, relating to the Licensed Products in the Field in the Territory, except for any Drug Registration Certificate that is required under Applicable PRC Laws to be filed in SELLAS’s name and will be owned by SELLAS. All 3DMed shall be responsible for the preparation of all Regulatory Filings relating Materials and all communications and interactions with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory shall be owned by Everest Territory, both prior to and held in Everest’s (or its Affiliates’ or Sublicensees’, as the case may be) namesubsequent to receipt of any Regulatory Approvals, provided that (a) for any 3DMed shall provide prior written notice and copies of all proposed material 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 (b) for any Regulatory FilingsMaterials, including any IND or Imported Drug LicenseMAA, that in each case in the form of an electronic copy in English, or if the originals are required under not written in English, together with translations into English, at least [***] in advance of filing for SELLAS’ review and comment, and 3DMed will consider in good fxxxx XXXXXX’ comments to such Regulatory Materials prior to filing such Regulatory Materials with the applicable Laws Regulatory Authorities. SELLAS shall provide reasonable assistance requested by 3DMed with respect to such Regulatory Materials, subject to Section 4.8. (b) Upon the request by a Regulatory Authority or Governmental Authority in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest 3DMed for any information or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 materials relating to the terms of Article 8 (Manufacturing and Supply), Xxxxx shall (itself or through its Affiliate or a CMO) continue Licensed Products that have not already been provided to Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with 3DMed under the terms of this Agreement Agreement, SELLAS shall promptly provide to 3DMed such information or materials to the extent that such information or materials are in SELLAS’ possession, readily available and within SELLAS’ Control. (c) Upon SELLAS’ reasonable request, 3DMed shall, as soon as practicable, provide SELLAS with (i) an electronic copy (in English, or if the Supply Agreements; originals are not written in English, together with the translations into English) of all material Regulatory Materials and correspondence with Regulatory Authorities or Governmental Authorities, including any IND or MAA, (ii) an electronic copy of all other Regulatory Materials and correspondence with Regulatory Authorities or Governmental Authorities, and (ziii) Xxxxx shall provide such a written summary in English of all other reasonable assistance interactions with Regulatory Authorities and Governmental Authorities, in each case by or on behalf of 3DMed or its Sublicensees with respect to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Development of the Licensed Products in the Territory due to Field in the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory FilingsTerritory.

Regulatory Activities. Everest (i) After AbbVie proceeds with the In-Licensing, AbbVie shall apply have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and maintainother filings or communications with the Regulatory Authorities). Ablynx shall support AbbVie, at Everest’s sole cost as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and expensein the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, Ablynx shall retain the right to prepare, obtain, and maintain all regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities) solely for Ablynx to perform the Development activities undertaken pursuant to Sections 3.1.2, 3.1.4 and 3.1.7. (ii) Upon AbbVie proceeding with the In-Licensing, all Regulatory Filings Documentation (including all Regulatory Approvals and Product Labeling) relating to the Licensed Compounds or Licensed Products in the Field in the Territory. All Regulatory Filings relating with respect to the Products in the Field in the Territory shall be owned by Everest by, and held in Everest’s (or its Affiliates’ or Sublicensees’, as shall be the case 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 sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee. Upon AbbVie proceeding with the In-Licensing, Ablynx hereby CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. assigns to AbbVie all of a local agent designated its right, title, and interest in and to all Existing Regulatory Documentation (including any existing Regulatory Approvals) and all other Regulatory Documentation Controlled by Everest; Ablynx from time to time during the Term and (b) for any Regulatory FilingsAblynx shall execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including any IND the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or Imported Drug Licenseas AbbVie may reasonably request in connection with, that are required under applicable Laws in or to carry out more effectively the Territory purpose of, or to be filed in Xxxxx’x namebetter assure and confirm unto AbbVie its rights under, such Regulatory Filings will be owned by Xxxxx but shall be preparedthis Section 3.7.1. Notwithstanding the foregoing, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, during the period that Xxxxx is the owner of any Xxxxx Territory Regulatory Filings, (x) Everest Ablynx shall have the right to Commercialize the Product; and reference such Regulatory Documentation (yincluding all Regulatory Approvals) subject relating to the terms Licensed Compounds or Licensed Products with respect to the Territory solely for Ablynx to perform the Development activities undertaken pursuant to Sections 3.1.2, 3.1.4 and 3.1.7. (iii) Commencing upon the assignment of Article 8 (Manufacturing and Supplyan IND by Ablynx to AbbVie pursuant to Section 3.7.1(ii), Xxxxx AbbVie shall have the sole right and responsibility to maintain in its name such IND, and to conduct communications with the applicable Regulatory Authorities with respect to such IND. Without limiting the foregoing, AbbVie shall have the sole right and responsibility to prepare, obtain and maintain in its name all other INDs necessary to perform its obligations under the Development Plan, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs. Notwithstanding the foregoing, Ablynx shall have the right and responsibility to maintain in its name an IND and to conduct communications with the applicable Regulatory Authorities with respect to such IND solely for Ablynx to perform the Development activities undertaken pursuant to Sections. 3.1.2, 3.1.4 and 3.1.7. (itself iv) AbbVie shall make every reasonable effort to notify Ablynx following its determination that any event, incident, or through circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Product in the Territory for the Initial Indications, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie (or its Affiliate Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If a CMO) continue to Manufacture and supply the Product for Development and Commercialization recall, market suspension, or market withdrawal is mandated by Everest and its Affiliates and Sublicensees a Regulatory Authority in the Territory, including AbbVie (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.7.1(iv), AbbVie (or its Sublicensee) responsible for the Manufacture recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and supply of the Product for any Early Access ProgramsAblynx shall reasonably cooperate in all such recall efforts. Subject to Article 11, in accordance with the terms of this Agreement if and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the fact extent that Xxxxx is required under applicable Laws to be the named applicant and owner of Regulatory Filings relating thereto. Xxxxx shalla recall, at the direction of and with the assistance of Everest, execute any documentation prepared by Everest necessary to appoint Everest, its Affiliatesmarket suspension, or Sublicensees as Xxxxx’x exclusive local regulatory agent to perform regulatory actions on market withdrawal resulted from a Party’s or its behalf in connection with Affiliate’s breach of its obligations hereunder, or from such Party’s or its Affiliate’s negligence or willful misconduct, such Party shall bear the Xxxxx Territory Regulatory Filingsexpense of such recall, market suspension, or market withdrawal.

Regulatory Activities. Everest (a) Qilu shall apply for and maintain, at EverestQilu’s sole cost and expense, all Regulatory Filings Documents relating to the Licensed Products in the Field in the Territory. All Regulatory Filings Documents relating to the Licensed Products in the Field in the Territory shall be owned by Everest Qilu and held in EverestQilu’s (or its Affiliates’ or Sublicensees’, as the case may be) name, provided that (a) except 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 (b) for any Regulatory FilingsDocuments, including any IND or Imported Drug License, that are required under applicable Applicable Laws in the Territory to be filed in Xxxxx’x Arbutus’ name, such which Regulatory Filings Documents will be owned by Xxxxx Arbutus, but shall be prepared, filed and maintained by Everest Qilu on Xxxxx’x Arbutus’ behalf (such Regulatory Filings in the Territory Documents owned by XxxxxArbutus, the “Xxxxx Arbutus Territory Regulatory FilingsDocuments”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the fact that Xxxxx is required under applicable Laws to be the named applicant and owner of Regulatory Filings relating thereto. Xxxxx Arbutus shall, at the direction of and with the assistance of EverestQilu, execute any documentation prepared by Everest Qilu necessary to appoint Everest, its Affiliates, or Sublicensees Qilu as Xxxxx’x exclusive Arbutus’ local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Arbutus Territory Regulatory FilingsDocuments. Qilu shall be responsible, at Qilu’s sole cost and expense, for all communications and interactions with Regulatory Authorities with respect to the Licensed Products in the Field in the 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 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 (z) 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 Documents within the Initial Documentation or (B) if no such consent is so included, comments on specific revisions to the Arbutus Territory Regulatory Documents so that consent may be granted. Additionally, if Qilu makes any material changes to any protocol synopsis included in the Initial Documentation or the material parts of such Regulatory Document as previously summarized by Qilu in the Initial Documentation, then Qilu shall provide 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 good faith Arbutus’ comments to any material Regulatory Documents relating to a Licensed Product prior to filing such Regulatory Documents with the applicable Regulatory Authorities; provided, that no Arbutus Territory Regulatory Document relating to a Licensed Product may be filed in the 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 Document original as filed in Chinese. In CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 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 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 relating to the Licensed 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 Territory; 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. (b) Within thirty (30) days of receipt or filing, Qilu shall provide Arbutus with an electronic copy (in Chinese) and an English translation of all correspondence with Regulatory Authorities or Governmental Authorities (other than, for clarity, any material Regulatory Document, copies of which are required to be provided in accordance with Section 4.3(a) above). For clarity, the English translation shall not include the translation of any attachments, appendices or other enclosures to or with the correspondence. After receiving Arbutus’ written request, Qilu shall provide to Arbutus, within a reasonable time, an English translation of such attachments, appendices or other enclosures to the extent the original is not written in English and 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. Additionally, upon the reasonable request of Arbutus, Qilu shall promptly provide Arbutus with an electronic copy (in Chinese) and an English written summary of all other interactions with Regulatory Authorities and Governmental Authorities, in each case by or on behalf of Qilu or its Affiliates or, to Qilu’s knowledge, Sublicensees with respect to the Development of the Licensed Products in the Field in the Territory.

Regulatory Activities. Everest (a) BMS (or its Affiliates or other designees) shall apply have the sole right to (i) prepare, obtain, and maintain INDs, Drug Approval Applications, Regulatory Approvals and other regulatory submissions and applications for Licensed Compounds and maintainLicensed Products (including as a single agent, at Everest’s sole cost for combination use or otherwise) in the Field in the Territory (including the setting of the overall regulatory strategy therefor), and expense(ii) conduct communications with Regulatory Authorities for Licensed Compounds and Licensed Products (including as a single agent, all Regulatory Filings relating to the Products for combination use or otherwise) in the Field in the Territory. All Without limiting Avidity’s obligations set forth in a Research Plan, Avidity shall provide support and assistance to BMS, as may be reasonably requested by BMS and subject to Section 7.12 (Cost of Avidity Support Services), in preparing, obtaining and maintaining INDs, Drug Approval Applications and Regulatory Filings relating to the Products Approvals for Licensed Products, and in the Field 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 requested by BMS, 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 Territory Parties, all Regulatory Documentation (including all Regulatory Approvals) for any Licensed Compound or Licensed Product shall be owned by Everest by, and held in Everest’s (or its Affiliates’ or Sublicensees’, as shall be the case 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 sole property and held in the name of a local agent designated by Everest; and of, BMS (or its Affiliate or other designee). (b) Without limiting the foregoing, at no cost to BMS (i) reasonably in advance of any preparation of an IND submission for any Regulatory FilingsLicensed Compounds and Licensed Products by BMS, including the Parties will meet to discuss the information to be included in such IND submission that specifically relates to the Avidity AOC Platform Technology, and Avidity will provide such information in its Control that it believes to be useful, and (ii) prior to any IND submissions for Licensed Compounds and Licensed Products by BMS, to the extent such IND submissions specifically relates to the Avidity AOC Platform Technology, BMS shall provide Avidity a draft copy of the portions of such IND that specifically relate to the Avidity AOC Platform Technology to allow Avidity to review to ensure consistency of language and information previously known to Regulatory Authorities regarding the Avidity AOC Platform Technology, and BMS shall reasonably consider any comments provided by Avidity within [***] of Avidity’s receipt of such draft copy that specifically relate to the Avidity AOC Platform Technology, and BMS will also provide Avidity with a final copy of the portion of such IND submissions that specifically relate to the Avidity AOC Platform Technology as filed with the Regulatory Authority. For clarity, in no event shall the foregoing discussions, support, and assistance provided by Avidity be subject to Section 7.12 (Cost of Avidity Support Services). (c) In addition, prior to any submission of regulatory documentation relating to the Avidity AOC Platform Technology by Avidity, to the extent such submissions specifically relates to any Licensed Compound or Imported Drug LicenseLicensed Product, that are required under applicable Laws Avidity shall provide BMS a draft copy of such documentation to allow BMS to review to ensure consistency of language and information previously known to Regulatory Authorities regarding the Licensed Compound or Licensed Product, and Avidity shall consider any comments timely provided by BMS in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), good faith; provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, during the period that Xxxxx is the owner of any Xxxxx Territory Regulatory Filings, (x) Everest shall have Avidity may redact any information that is not specifically related to the right to Commercialize the Product; Licensed Compound or Licensed Product and (y) subject Avidity will not have to the terms provide BMS with any regulatory documentation, information or materials related to a compound or product being Developed or Commercialized by a Third Party licensee of Article 8 (Manufacturing and Supply), Xxxxx shall (itself or through its Affiliate or a CMO) continue to Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory FilingsAvidity.

Regulatory Activities. Everest Ocumension will use Commercially Reasonable Efforts to obtain Regulatory Approvals for the Product from the 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 apply for and maintain, at Everest’s sole cost and expense, own all Regulatory Filings Materials and Regulatory Approvals of the Product in the Territory 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 upon request by Alimera, shall reasonably cooperate in the assignment of such Regulatory Approval to Alimera or a designated entity; provided, however, that Alimera shall be solely responsible for costs and expenses relating to the Products foregoing. Ocumension shall be responsible for the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the Product in the Field in the Territory, both prior to and subsequent to receipt of Regulatory Approval, and Alimera shall provide reasonable assistance requested by Ocumension with respect thereto. All Upon the request by a Regulatory Filings Authority in the Territory to Ocumension for any information or materials relating to the 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 Field in the Territory shall be owned by Everest and held in EverestAlimera’s (or its Affiliates’ possession, readily available or Sublicensees’, as the case 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 (b) for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest within Alimera’s or its designee if and when permitted by applicable Laws. For the avoidance of doubt, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory Filings’ Control.

Regulatory Activities. Everest shall apply for 2.2.1 All IDEs and maintain, at Everest’s sole cost and expense, all Regulatory Filings relating to the Products in the Field in the Territory. All Regulatory Filings relating to the Products in the Field in the Territory Approvals shall be owned by Everest and held in Everest’s (or its Affiliates’ or Sublicensees’, as the case 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 Surmodics, except in cases in which (i) Surmodics is not permitted by Applicable Law to hold an CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. IDE or a local agent designated Regulatory Approval in a given country, (ii) Surmodics does not meet the requirements of Applicable Law in a given country to hold an IDE or a Regulatory Approval, or (iii) Abbott has the right to obtain and maintain a Regulatory Approval pursuant to Section 2.2.4, in which case ((i), (ii), or (iii)) Abbott may elect for Abbott or its Affiliate or a Third Party mutually agreed by Everest; the Parties in writing (with each Party’s agreement not to be unreasonably withheld, conditioned, or delayed) to own or hold such IDEs or Regulatory Approvals, as applicable. 2.2.2 Regardless of whether or not Surmodics holds an IDE or Regulatory Approval in a given country or jurisdiction, Surmodics shall be responsible for preparing and submitting all IDEs and Device Approval Applications, supplements thereto, and any other submissions necessary to obtain and maintain any IDE or Regulatory Approval, including preparing any supplements or other filings to support new indications and for conducting all communications with Regulatory Authorities with regard to the Product, including responses to additional information letters or deficiency letters, except (i) those communications relating to Pricing Approvals or relating to the approval of promotional materials for use with the Product and (bii) communications relating to Commercialization or Manufacturing activities of Abbott or its Affiliates or their respective (sub)licensees or (sub)distributors. Without limiting Surmodics’ obligations under this Section 2.2.2, if Abbott has the right to obtain and maintain a Regulatory Approval pursuant to Section 2.2.4, Abbott shall have the right, but not the obligation, to prepare and submit all IDEs and Device Approval Applications, supplements thereto, and any other submissions necessary to obtain and maintain such Regulatory Approval, including preparing any supplements or other filings to support new indications and for conducting all communications with Regulatory Authorities with regard to the Product with respect to such Regulatory Approval, including responses to additional information letters or deficiency letters. 2.2.3 The Parties will confer and cooperate with one another through the JDC with respect to all dealings with Regulatory Authorities and with all aspects of Regulatory Approval for the Product. 2.2.4 Surmodics shall obtain and maintain Regulatory Approvals for the Product in the United States and the European Union and shall, upon Xxxxxx'x request in respect of a country in the Territory outside of the United States and the European Union, and subject to Xxxxxx’x satisfaction of its obligations, if any, under Section 2.1.2 with respect to such country, use Commercially Reasonable Efforts to obtain and maintain Regulatory Approvals for the Product in such country. Abbott shall support Surmodics, on Surmodics’ request and as may be reasonably necessary, in obtaining and maintaining Regulatory Approvals for the Product. The Parties shall mutually agree on a commercially reasonable timeframe to obtain any Regulatory FilingsApproval for the Product in any country in the Territory for which Abbott has requested Surmodics obtain and maintain Regulatory Approvals pursuant to this Section 2.2.4. If Surmodics fails to obtain any such Regulatory Approval for the Product within the mutually agreed timeframe, is not reasonably expected to be able to obtain any such Regulatory Approval for the Product within the mutually agreed timeframe, or fails to maintain any such Regulatory Approval for the Product, Abbott shall have the right, but not the obligation, to obtain and maintain such Regulatory Approvals for the Product in the applicable country, and Surmodics shall provide such support and assistance as Abbott may reasonably request (including by CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 2.2.5 If a Party is the sponsor of a Clinical Study conducted as part of its Party Development Activities, such Party (or its designee) shall have the right and responsibility to fulfil the obligations of a sponsor as specified in 21 C.F.R. Part 812, Subpart C, and the equivalent obligations in other countries or regulatory jurisdictions, including any IND reports, filings, or Imported Drug Licensecommunications with Regulatory Authorities that may be required to fulfil such obligations, that are required under applicable Laws and the other Party shall support the sponsoring Party, as may be reasonably necessary, in respect of such obligations. 2.2.6 Surmodics shall provide Abbott with an opportunity to review and comment on all Regulatory Authority meeting requests and on all submissions, filings, and proposed communications to Regulatory Authorities, in each case relating to the Product in the Territory to be filed in Xxxxx’x name(collectively, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Product Regulatory Filings”), provided that Xxxxx . Surmodics shall promptly transfer and assign all Xxxxx Territory provide access to interim drafts of such Product Regulatory Filings to Everest Abbott via the access methods (such as secure databases) established by the JDC, and Abbott shall provide its comments on such Product Regulatory Filings or on proposed material actions within [**], or such other longer period of time mutually agreed to by the Parties. In the event that a Regulatory Authority establishes a response deadline for any such Product Regulatory Filing or material action shorter than such period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. Surmodics shall reasonably consider Xxxxxx’x comments, requests and suggestions. 2.2.7 Subject to Section 2.2.8, Surmodics shall provide Abbott with (i) access to or copies of all written or electronic correspondence (other than Product Regulatory Filings) relating to the Development or Commercialization of the Product received after the Effective Date by Surmodics or its designee if from, or forwarded by Surmodics or its designee to, the Regulatory Authorities in the Territory, and when permitted (ii) copies of all meeting minutes and summaries of all meetings, conferences, teleconferences, and discussions held by applicable Laws. For Surmodics or its designee after the avoidance Effective Date with the Regulatory Authorities in the Territory, including copies of doubtall contact reports produced by Surmodics or its designee, during in each case ((i) and (ii)) within [**] of its receipt, forwarding or production of the period that Xxxxx is foregoing, as applicable. 2.2.8 Each Party shall provide the owner other Party with prior written notice, to the extent such Party has advance knowledge, of any Xxxxx scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory Regulatory Filingsrelating to the Product, within [**] after such Party or its designee first receives notice of the scheduling of such meeting, conference, or discussion (xor within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to attend as an observer (but not participate in) Everest such meeting, conference, or discussion). The other Party shall have the right to Commercialize the Product; have two (2) of its representatives attend as an observer (but not participate in) all such meetings, conferences, 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 Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory Filingsdiscussions.

Regulatory Activities. Everest (a) As between the Parties, AGT shall apply for and have the [ * ] right to prepare, obtain, maintain, at Everest’s sole cost and expensehold the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Filings relating Approvals and other submissions, and to conduct communications with the Products in the Field in the Territory. All Regulatory Filings relating to the Authorities, for Licensed Compounds and Licensed Products in the Field in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to Development activities). Licensor shall support AGT, at AGT’s cost and expense, as may be owned reasonably necessary, in obtaining Regulatory Approvals for the Licensed Compounds and Licensed Products, and in the activities in support thereof, including by Everest promptly providing safety data (including, for clarity, serious adverse event reports) for the 4D Vector (including such data and held reports arising from AAV-based gene therapy products that utilize the 4D Vector) to AGT in Everestorder for AGT (or its Affiliates or Sublicensees) to obtain Regulatory Approvals, in each case to the extent in Licensor’s (or its Affiliates’ or Sublicensees’, as possession and Control. (b) All Regulatory Documentation (including all Regulatory Approvals and product labeling) [ * ] the case may be) name, provided that (a) for any Regulatory Filings, including any Marketing Approval, that are required under applicable Laws in a Region in Licensed Compounds and Licensed Products with respect to the Field and the Territory to developed by or on behalf of AGT or its Affiliates or Sublicensees (and for clarity, not by Licensor or its Affiliates or (sub)licensees) shall be filed in owned by, and shall be the name of a local agent, such Regulatory Filings may be filed sole property and held in the name of a local agent designated by Everest; and (b) for any Regulatory Filingsof, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest AGT or its designee if designated Affiliate, Sublicensee or other designee; provided that, for clarity, Licensor shall retain ownership of (i) its safety information and when permitted by applicable Laws. For the avoidance of doubt, during the period that Xxxxx is the owner of any Xxxxx Territory Regulatory Filings, 4D Vector drug master files (x“4D Vector DMF”) Everest shall have the right to Commercialize the Product; and (y) subject other documentation or information relating to the terms 4D Vector developed by or on behalf of Article 8 (Manufacturing and Supply), Xxxxx shall (itself Licensor or through its Affiliate or a CMO) continue to Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of provided to AGT pursuant to ARTICLE 9 or this Agreement and the Supply Agreements; Section 3.5.1 and (zii) Xxxxx its own regulatory documentation relating to the 4D Vector developed by or on behalf of Licensor or its Affiliates. (c) Upon each Party’s reasonable request, the other Party shall provide such other reasonable assistance to Everest, including by providing documentation the requesting Party with safety information or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due safety data relating to the fact that Xxxxx 4D Vector, to the extent such information is in such Party’s possession and Control and is required under by the 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 Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf Authority in connection with the Xxxxx Territory requesting Party obtaining or maintaining Regulatory FilingsApproval for Licensed Products (if AGT is the requesting Party) or other products controlled by Licensor or its Affiliates (if Licensor is the requesting Party); provided, however, that, if the information requested relates to analytical and quality control data, stability data, or other chemistry, manufacturing, and control data, then, at the providing Party’s option (and in all cases if such disclosure is precluded by Section 4.2), and upon prior written notice to the requesting Party, the providing Party shall provide such information or data directly to the applicable Regulatory Authority, in which case, the providing Party shall notify the requesting Party in writing once such information or data has been provided. The providing Party shall use reasonable efforts to provide such data prior to any timelines requested by the applicable Regulatory Authority. Notwithstanding the foregoing, this Section 3.5.1(c) shall not require either Party to disclose to the other Party or any Regulatory Authority (a) [ * ] or (b) in the case of Licensor, any data or information comprising the Excluded Licensor IP or, in the case of AGT, any Manufacturing information, in each case, except to the extent required by Applicable Law. (d) Licensor hereby grants to AGT a right of reference to, and a right to use and rely upon, (i) any Regulatory Documentation solely to the extent containing safety information relevant to the 4D Vector that is Controlled by Licensor or its Affiliates and (ii) the 4D Vector DMF. Licensor shall execute such documents or instruments reasonably required to provide such right of reference or right of use promptly following written request by AGT. AGT hereby grants to Licensor a right of reference to, and a right to use and rely upon, any Regulatory Documentation generated by or on behalf of AGT or its Affiliates or Sublicensees in connection with this Agreement solely to the extent containing safety information relevant to the 4D Vector that is Controlled by AGT or its Affiliates. AGT shall execute such documents or instruments reasonably required to provide such right of reference or right of use promptly following written request by Licensor. (e) AGT (or its Affiliate or Sublicensee) shall have the sole (as between the Parties) right to make the final determination whether to voluntarily implement any recall, market suspension, or market withdrawal of its, its Affiliate or Sublicensee’s Licensed Compounds and Licensed Products in the Territory. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.5.1(e), AGT (or its Affiliate or Sublicensee) shall be solely responsible for the execution thereof.