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) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting 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). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the extent UGNX remains Effective Date. b) Xynomic shall notify the Lead Development Party with respect to Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a particular territoryrecall, subject to market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in accordance with such notice the terms reasoning behind such determination, and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file any supporting facts. Xynomic (or its Sublicensee) shall have filed) all Regulatory Filings with respect the right to make the Licensed Products final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Field Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in order to obtain Marketing Approvals in each country good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory and the European Territory Territory, Xynomic (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 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”this Section 2.2.1.b), provided that KHK will have primary responsibility for obtaining, and UGNX Xynomic (or its Sublicensee) shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals be solely responsible for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, execution 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 Fieldthereof.

Regulatory Activities. Beginning on 5.1 As between the Effective Date Parties, SutroVax shall be solely responsible for preparing and filing of any and all regulatory submissions for Vaccine Compositions in the Territory and shall own all related regulatory materials, provided, however , that Sutro shall have the authority to approve, and have final responsibility for, the CMC portions of such submissions and materials to the extent UGNX remains relating to the Lead Development Party manufacturing of Extracts. 5.2 SutroVax shall keep Sutro informed of pre-clinical, clinical and regulatory developments relating to Vaccine Compositions in the Territory through regular reports to Sutro as set forth in Section 7.3, and SutroVax shall promptly notify Sutro of any Regulatory Approval received for each Vaccine Composition in the Territory. SutroVax shall provide Sutro for review and comment the relevant CMC portions and portions concerning product safety of draft material regulatory filings with respect to Vaccine Compositions at least [***] days in advance of their intended date of submission to a regulatory authority in the Territory and shall consider in good faith any comments thereto provided by Sutro. SutroVax shall promptly notify Sutro with copies of any such CMC portions and portions concerning product safety of material regulatory submissions or communications submitted to or received from any regulatory authority in the Territory and shall provide Sutro with copies thereof within [***] days after submission or receipt. SutroVax shall provide Sutro with reasonable advance notice of all meetings, conferences, and discussions scheduled with any regulatory authority in the Territory in each case to the extent concerning relevant CMC information, adverse events or other safety information with respect to a particular territoryVaccine Composition, subject and shall consider in good faith any input from Sutro in preparing for such meetings, conferences or discussion. To the extent permitted by applicable laws, Sutro shall have the right to participate, in any such meetings, conferences or discussions to the extent the same concern CMC information, CMC activities, adverse events or other safety information with respect to any Vaccine Composition. For clarity, and notwithstanding any of the foregoing, SutroVax’s obligations under this Section 5.2, including with respect to any regulatory developments, Regulatory Approvals, regulatory filings, submissions, communications, meetings, conferences, and discussions, and safety information , shall in accordance each case (i) apply only to the extent they are directed to CMC information or CMC activities, adverse events or other safety information that are pertinent to use of the Sutro Platform within the Vaccine Field and (ii) to the extent that SutroVax has the right to comply under its agreements with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) Third Parties; provided that in any case SutroVax shall use Commercially Reasonable Efforts to file keep Sutro reasonably informed regarding progress of the Vaccine Compositions. 5.3 SutroVax shall (i) promptly provide Sutro any and all relevant CMC data and evaluations, adverse event reports and other safety information controlled by SutroVax that are generated from development and testing (including without limitation human clinical trials) performed or sponsored by any of SutroVax, its Affiliates, or Sublicensees with respect to any Vaccine Composition, all to the extent the same contain CMC information, adverse event or other safety information pertinent to use of the Sutro Platform outside the Vaccine Field, and (ii) xxxxx Xxxxx, its Affiliates and Third Party licensees to whom Sutro has granted rights to the Sutro Platform, the right to reference any regulatory filings and Regulatory Approvals controlled by SutroVax that are filed by SutroVax, its Affiliates or Sublicensees with respect to any Vaccine Compositions, to the extent reasonably necessary or useful for obtaining Regulatory Approvals for products produced using the Sutro Platform outside the Vaccine Field (in each case of (i) and (ii), to the extent SutroVax has the right to grant such rights to Sutro). Similarly, upon SutroVax’s request, Sutro agrees to grant SutroVax, its Affiliates and Sublicensees the right to reference any regulatory filings and Regulatory Approvals controlled by Sutro that are filed by Sutro, its Affiliates or Third Party licensees with respect to any products produced using the Sutro Platform, to the extent reasonably necessary or useful for obtaining Regulatory Approvals for Vaccine Compositions (in each case, to the extent Sutro has the right to grant such rights to SutroVax). 5.4 As requested by SutroVax from time to time, Sutro shall reasonably cooperate with and provide assistance to SutroVax in connection with the preparation, submission and maintenance of regulatory applications and other filings to regulatory authorities regarding any Vaccine Composition, to the extent they require information controlled by Sutro or its contractors, provided, however, that following the Series A Financing Close, the performance of the foregoing activities shall be subject to the payment to Sutro of all documented time spent by Sutro’s personnel to perform such assistance and/or out-of-pocket costs for performing such activities. Accordingly, Sutro shall promptly provide SutroVax upon SutroVax’s written request with all available information controlled by Sutro or its Affiliates as reasonably necessary for SutroVax to apply for, obtain, and maintain such regulatory applications and filings in any country regarding any Vaccine Composition. To the extent that Sutro may reasonably satisfy such requirements by submitting and maintaining one or more Drug Master Files or other similar regulatory filings with the FDA and other regulatory authorities for the Extracts or Vaccine Compositions, Sutro may satisfy its obligation under this Section 5.4 by doing so and providing SutroVax, its Affiliates and Sublicensees appropriate rights to reference such Drug Master Files or such other confidential regulatory materials, and Sutro further agrees to make such filings and provide such rights of reference if requested by SutroVax (it being understood that SutroVax, its Affiliates and Sublicensees shall not have access to the information contained of such Drug Master Files or other confidential regulatory materials). Further, Sutro agrees, at SutroVax’s request and expense, to execute, acknowledge and deliver such further instruments, and take such other actions, all as promptly as possible, which may reasonably be necessary or appropriate to assist in the filing for, preparation, submission and maintenance of such regulatory applications, filings and communications, to the extent Sutro has the right to do so. Without limiting the foregoing, Sutro shall keep SutroVax reasonably informed on regulatory matters affecting or implicating the Sutro Platform generally to the extent such matters would be reasonably expected to have a material impact on Vaccine Compositions. For clarity, and notwithstanding any of the foregoing, Sutro’s obligations under this Section 5.4, shall (i) apply only to the extent the regulatory information is directed to CMC information or CMC activities, adverse events or other safety information that are pertinent to use of the Sutro Platform within the Vaccine Field or (subject to the last sentence of Section 5.4) is otherwise reasonably necessary for the preparation, submission and maintenance of regulatory applications and other filings to regulatory authorities in the United States, Europe or Japan regarding any Vaccine Composition, and (ii) to the extent that Sutro has the right to comply under its agreements with Third Parties. 5.5 Sutro shall permit applicable regulatory authorities to conduct inspections of its manufacturing facilities, inspect and make copies of any relevant records (or have filedcopies thereof, as applicable) all Regulatory Filings as they may request and shall cooperate with such regulatory agencies with respect to the Licensed Products inspections and any related matters, in each case which is related to any Vaccine Composition or the manufacture thereof. Sutro shall give SutroVax prior notice, to the extent practicable, of any inspections of its facilities relevant to use of the Sutro Platform for Vaccine Compositions, and keep SutroVax informed about the results and conclusions of each such regulatory inspection, including actions taken to remedy conditions cited in the Field in order to obtain Marketing Approvals inspections. Sutro will promptly provide SutroVax with copies of any written inspection reports issued by the applicable regulatory authority and all correspondence between Sutro and regulatory authorities, 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 case to the Licensed Products in extent 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 same relate to the Core Development Activities (“Regulatory Activities”)production of Extract for Vaccine Compositions or production of Vaccine Compositions supplied hereunder and similarly, provided that KHK will have primary responsibility for obtainingSutro agrees to promptly notify and provide SutroVax copies of any request, directive or other communication of regulatory authority relating to Extracts related to Vaccine Compositions or Vaccine Compositions supplied hereunder, and UGNX shall provide all assistance reasonably requested by KHKto cooperate with SutroVax in responding to such requests, 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, directives 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 Activitiescommunications, it being understood that any materials provided to SutroVax under this Section 5.5 shall be deemed Discloser’s Information of Sutro under Section 10.1; each as further described in the costs incurred by UGNX in connection applicable Extract Supply Agreement or Vaccine Composition Supply Agreement, as applicable. 5.6 Sutro further agrees to reasonably cooperate with such activities will be shared equally SutroVax to allow SutroVax’s potential Sublicensees or partners to conduct reasonable due diligence with respect to the supply of Extracts or Vaccine Compositions prior to execution of a Sublicense agreement (50/50but excluding for clarity any audit of Sutro’s processes, documentation and personnel). All The applicable Extract Supply Agreement or Vaccine Composition Supply Agreement for the particular Vaccine Composition(s) licensed to such Regulatory Activities Sublicensee will be conducted in include reasonable and customary provisions for Sublicensees, after execution of a manner consistent with Sublicense agreement, to perform quality assurance reviews relevant to the Core Development Plan and coordinated by production of Vaccine Compositions; provided that such provisions will limit the JSC in accordance with Article 3. Without limiting the applicability Sublicensee’s access to confidential information of the foregoing Sutro pertaining to methods, parameters, processes and the remainder of like used to produce Extract. Sutro shall use Commercially Reasonable Efforts to obtain from its contractors commitments similar to those contemplated in 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 FieldSection 5.6.

Regulatory Activities. Beginning on (a) As between the Effective Date Parties, Licensee shall have the sole responsibility, at its expense, for preparing, obtaining, and to maintaining Drug Approval Applications (including the extent UGNX remains setting of the Lead Development Party overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to a particular territory, subject to INDs and in accordance other filings or communications with the terms and conditions of this Agreement and Regulatory Authorities). All Regulatory Approvals relating to the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (Licensed Compounds or have filed) all Regulatory Filings Licensed Products with respect to the Licensed Products Territory shall be owned by, and shall be the sole property and held in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (name of, Licensee 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; its Affiliate or Sublicensee or their respective designees. (b) respond Licensee shall notify the AbbVie Alliance Manager promptly (but in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the Field need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory Territory, and shall include in such notice the European reasoning behind such determination, and any supporting facts. Licensee (or its Affiliate or 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; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Licensee shall consult with AbbVie and shall consider AbbVie’s comments in good faith. If a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product is mandated by a Regulatory Authority in the Territory, Licensee (cor its Affiliate or Sublicensee or their respective designees) meet shall initiate such a recall, market suspension, or market withdrawal of in compliance with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to the Core Development Activities (“Regulatory Activities”this Section 3.2.1(b), provided that KHK will have primary responsibility for obtaining, and UGNX Licensee (or its Affiliate or Sublicensee or their respective designees) shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals be solely responsible for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, execution 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 Fieldthereof.

Regulatory Activities. Beginning on (i) After Xxxxxx proceeds with the Effective Date In-Licensing, Xxxxxx 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 submissions, and to conduct communications with the extent UGNX remains Regulatory Authorities, for Licensed Compounds or Licensed Products in the Lead Development Party Territory (which shall include filings of or with respect to a particular territoryINDs and other filings or communications with the Regulatory Authorities). Galapagos shall support Xxxxxx, subject 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 and obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the requirements of Applicable Lawsapplicable Development Plan and Budget. (ii) Upon Xxxxxx proceeding with the In-Licensing, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings Documentation (including all Regulatory Approvals and Product Labeling) relating to the Licensed Compounds or Licensed Products with respect to the Licensed Products Territory shall be owned by, and shall be the sole property and held in the Field name of, Xxxxxx or its designated Affiliate, Sublicensee or designee. Upon Xxxxxx proceeding with the In-Licensing, Galapagos hereby assigns to Xxxxxx all of its right, title, and interest in order and to obtain Marketing Approvals in each country in the Territory and the European Territory all Existing Regulatory Documentation (or to obtain the European Centralized Approval in the European Core Territoryincluding any existing Regulatory Approvals) and in order all other Regulatory Documentation Controlled by Galapagos from time to obtain Pricing and/or Reimbursement Approvals in time during the Profit Share Territory; (b) respond in a timely fashion Term, and Galapagos shall execute and deliver, or cause to requests for data be duly executed and information from Regulatory Authorities with respect delivered, such instruments and shall do and cause to be done such acts and things, including the Licensed Products in the Field in the Territory filing of such assignments, agreements, documents, and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times instruments, as may be requested by such necessary under, or as Xxxxxx may reasonably request in connection with, or to carry out more effectively the purpose of, or to better assure and confirm unto Xxxxxx its rights under, this Section. (iii) Xxxxxx shall provide Galapagos with an opportunity to review and comment on all major regulatory filings and documents (including INDs, Drug Approval Applications, material labeling supplements, Regulatory Authorities with respect to Authority meeting requests, and core data sheets) for the Core Development Activities Initial Indication in the United States, Japan and the Major Markets (collectively, “Major Regulatory ActivitiesFilings”), provided that KHK will have primary responsibility for obtaining, and UGNX . Xxxxxx shall provide all assistance reasonably requested access to interim drafts of such Major Regulatory Filings to Galapagos via the access methods (such as secure databases) established 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, and Galapagos shall keep KHK reasonably informed provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within […***…] ([…***…]) Business days ([…***…] ([…***…]) Business days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. If a Regulatory Authority establishes a response deadline for any such Major Regulatory Filing or material action shorter than such […***…] ([…***…]) Business day (or […***…] ([…***…]) Business day) period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. Xxxxxx shall, and shall cause its Affiliates and Sublicensees to, consider in good faith any such comments of Galapagos. (iv) Subject to the immediately following sentence, Xxxxxx shall provide Galapagos with (A) access to or copies of all material events and developments occurring in written or electronic correspondence (other than regulatory filings) relating to the course Development or Commercialization of Licensed Compounds or Licensed Products for the Regulatory ActivitiesInitial Indication received by Xxxxxx or its Affiliates or Sublicensees from, including scheduled UGNX regulatory strategy discussions and meetings with or forwarded by Xxxxxx or its Affiliates or Sublicensees to, the Regulatory Authorities in the Territory United States, Japan and in the European Territory Major Markets, and (B) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by Xxxxxx or its Affiliates or Sublicensees with the Regulatory Authorities relating to the Development or Commercialization of Licensed Compounds or Licensed Products for the Initial Indication in the FieldUnited States, Japan and in the Major Markets, including copies of all contact reports produced by Xxxxxx or its Affiliates or Sublicensees, in each case ((A) and (B)) within […***…] ([…***…]) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval for a Licensed Product for the Initial Indication, the prohibition or suspension of the supply of a Licensed Compound or Licensed Product for the Initial Indication, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Licensed Compound or Licensed Product for the Initial Indication, Xxxxxx shall notify Galapagos and provide Galapagos with copies of such written or electronic correspondence as soon as practicable. (v) Xxxxxx shall provide Galapagos with prior written notice, to the extent Xxxxxx has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the United States, Japan and in the Major Markets relating to a Licensed Product for the Initial Indication, reasonably promptly after Xxxxxx or its Affiliate or Sublicensee first receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give Galapagos a reasonable opportunity to attend such meeting, conference, or discussion). Galapagos shall have the right to have two (2) of Galapagos’ employees attend as an observer (but not participate in) all such meetings, conferences, and discussions. (vi) Xxxxxx shall make every reasonable effort to notify Galapagos promptly following its determination that any event, incident, or 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 Indication, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xxxxxx (or its 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 recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xxxxxx (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(vi), Xxxxxx (or its Sublicensee) responsible for the recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and Galapagos shall reasonably cooperate in all such recall efforts. Subject to Article 11, (A) If and to the extent that a recall, market suspension, or market withdrawal resulted from a Party’s or its 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 expense of such recall, market suspension, or market withdrawal, (B) with respect to any recall, market suspension, or market withdrawal of a Co-Promotion Product in the Co-Promotion Territory other than in clause (A) above, the expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal shall be included in Allowable Expenses hereunder and shared by the Parties pursuant to Section 6.9.1, and (C) with respect to any recall, market suspension, or market withdrawal not covered by clause (A) or (B), Xxxxxx shall be responsible for all costs of such recall, market suspension, or market withdrawal and deducted from Net Sales pursuant to Article 6.

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 Except for the performance of [***] or an Additional Clinical Trial, Alexion shall have the sole right and responsibility, [***], for all regulatory activities leading up to file (or and including the obtaining, holding and maintaining of Regulatory Approvals for Licensed Products from Regulatory Authorities in the Field in the Territory. Notwithstanding the foregoing, Eidos shall have filed) all the right to have [***] of Eidos accompany Alexion to each meeting with Regulatory Filings with respect Authorities in the Territory pertaining solely to the Licensed Products in an observational capacity only, and solely to the extent such attendance is permitted by the applicable Regulatory Authorities in the Territory. (b) At any time following the Effective Date upon Alexion’s request, Eidos shall promptly transfer to Alexion ownership of all Regulatory Approvals and Regulatory Documents in the Field in order to obtain Marketing Approvals the Territory in each country Eidos’ Control. Notwithstanding the foregoing, if [***], Eidos shall obtain, hold and maintain all Regulatory Documents in the Territory [***], and shall thereafter promptly transfer to Alexion ownership of such Regulatory Documents. Notwithstanding anything to the European Territory (contrary in this Agreement, Alexion or to obtain the European Centralized Approval its designee shall own all Regulatory Approvals and, except as expressly set forth 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 preceding sentence, all other Regulatory Authorities Documents, with respect to the Licensed Products in the Field in the Territory and the European Territory; and . (c) meet Eidos shall in good faith cooperate with officials of Alexion in obtaining, holding and maintaining any Regulatory Approvals, for a Licensed Product in the Regulatory Authorities at such times as may be requested Field in the Territory by such Regulatory Authorities with respect providing, to the Core Development Activities (“Regulatory Activities”extent Controlled by Eidos and not already transferred to Alexion pursuant to Section 2.5 or Section 4.5(b), provided that KHK will have primary responsibility for obtaining, reasonable access to Regulatory Approvals and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals Regulatory Documents for the Licensed Compound and Licensed Products in the Field in the European Territory. For Territory or 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 ROW Territory and the European Territory relating reasonable access to and a copy of any and all Product Data (including raw data and records) with respect to the Licensed Products in Compound and Licensed Products. (d) At Alexion’s reasonable request, Eidos shall, [***], reasonably assist Alexion with the Fieldpreparation and filing of (i) any regulatory filings and associated documents or (ii) any specific technical documents required for Regulatory Approval.

Regulatory Activities. Beginning on 4.1.1 As between the Effective Date Parties, Takeda shall have the sole right to prepare, obtain and maintain Regulatory Approvals (including the setting of the overall regulatory strategy therefor) and other submissions and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance conduct communications with the terms and conditions of this Agreement and the requirements of Applicable LawsRegulatory Authorities, UGNX, shall: (a) use Commercially Reasonable Efforts to file (for SLT-A Fusion Proteins 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 (which shall include filings of or with respect to obtain INDs and other filings or communications with 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 Program Activities). MTEM shall not file any IND with respect to any SLT-A Fusion Protein prior to the Licensed Products in expiration of all Option Periods hereunder, and then only with respect to Targets other than the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times Takeda Targets that [***] Replacement Target or otherwise terminated as a Takeda Target. MTEM shall support Takeda, 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 KHKnecessary, in relation to Pricing and/or Reimbursement obtaining Regulatory Approvals for the Licensed Products and in the Field activities in support thereof, including providing all documents or other materials in the European Territory. For the avoidance possession or control or MTEM or any of doubt, UGNX will its Affiliates as may be responsible necessary or useful for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation Takeda or any of its Affiliates or its or their Sublicensees to Pricing and/or Reimbursement Approvals, if any, obtain Regulatory Approvals for the Licensed Products including access to the contents in the Field in Drug Master File, as well as other MTEM Regulatory Documentation that are necessary or useful to compile the Profit Share Territory Chemistry Manufacturing and Controls section of an IND submission or an application for Regulatory Approval with respect to a Licensed Product and such other relevant information MTEM has created or possesses or Controls 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 Takeda may reasonably request. 4.1.2 All Regulatory Documentation (50/50). All such including all 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(iesApprovals) 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 with respect to the Territory shall be owned by, and shall be the sole property and held in the Fieldname of, Takeda or its designated Affiliate, Sublicensee or designee. Promptly following the exercise of an Option with respect to a Designated Target, MTEM shall, and does hereby, assign, and shall cause its Affiliates and its and their licensees and Sublicensees to so assign, to Takeda or its designated Affiliate, Sublicensee or designee, without additional compensation, all of its right, title and interest in and to all Regulatory Documentation to the extent solely relating to any Licensed Product.

Regulatory Activities. Beginning on (i) After AbbVie proceeds with the Effective Date In-Licensing, AbbVie 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 submissions, and to conduct communications with the extent UGNX remains Regulatory Authorities, for Licensed Compounds or Licensed Products in the Lead Development Party Territory (which shall include filings of or with respect to a particular territoryINDs and other filings or communications with the Regulatory Authorities). Ablynx shall support AbbVie, subject 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 and obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the requirements 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 Applicable Lawsor 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, UGNXand 3.1.7. (ii) Upon AbbVie proceeding with the In-Licensing, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings Documentation (including all Regulatory Approvals and Product Labeling) relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the 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 assigns to AbbVie all of its right, title, and interest in and to all Existing Regulatory Documentation (including any existing Regulatory Approvals) and all other Regulatory Documentation Controlled by Ablynx from time to time during the Term and Ablynx 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 the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or as AbbVie may reasonably request in connection with, or to carry out more effectively the purpose of, or to better assure and confirm unto AbbVie its rights under, this Section 3.7.1. Notwithstanding the foregoing, Ablynx shall have the right to reference such Regulatory Documentation (including all Regulatory Approvals) relating to the Licensed Compounds or Licensed Products in the Field in order with respect to obtain Marketing Approvals in each country in the Territory solely for Ablynx to perform the Development activities undertaken pursuant to Sections 3.1.2, and 3.1.7. 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. (iii) Commencing upon the European Territory (or assignment of an IND by Ablynx to obtain AbbVie pursuant to Section 3.7.1(ii), AbbVie shall have the European Centralized Approval sole right and responsibility to maintain in its name such IND, and to conduct communications with 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 applicable Regulatory Authorities with respect to such IND. Without limiting the Licensed Products 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 Field in Development Plan, and to conduct communications with the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such applicable Regulatory Authorities with respect to such INDs. Notwithstanding the Core Development Activities (“Regulatory Activities”)foregoing, provided that KHK will Ablynx shall have primary the right and responsibility for obtaining, to maintain in its name an IND 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 conduct communications with the applicable Regulatory Authority(iesAuthorities with respect to such IND solely for Ablynx to perform the Development activities undertaken pursuant to Sections. 3.1.2, and 3.1.7. (iv) andAbbVie shall make every reasonable effort to notify Ablynx following its determination that any event, through the JDCincident, shall keep KHK reasonably informed of all material events and developments occurring or circumstance has occurred that may result in the course need for a recall, market suspension, or market withdrawal of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities a Licensed Product in the Territory for the Initial Indications, and shall include in such notice the European Territory relating reasoning behind such determination, and any supporting facts. AbbVie (or its 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 recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, 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 recall, market suspension, or market withdrawal shall be solely responsible for the execution thereof, and Ablynx shall reasonably cooperate in all such recall efforts. Subject to Article 11, if and to the Licensed Products in extent that a recall, market suspension, or market withdrawal resulted from a Party’s or its 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 Fieldexpense of such recall, market suspension, or market withdrawal.

Regulatory Activities. Beginning on a) As between the Parties, Licensee shall have the sole responsibility for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compound 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). All Regulatory Approvals relating to the Licensed Compound or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Licensee or its designated Affiliate or Sublicensee. Licensor hereby assigns to Licensee all of Licensor’s (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Licensor (or its Affiliates) and held in Licensor’s name (or its Affiliates) as of the Effective Date and to the extent UGNX remains the Lead Development Party with respect listed in Schedule 3.2.1 and shall electronically transfer all INDs listed on Schedule 3.2.1 to a particular territory, subject to U.S. based entity controlled by Licensee on a date mutually agreed upon by the Parties. Upon assignment 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 transfer of the Regulatory Authorities at Documentation and the provision of applicable notice to Regulatory Authorities, Licensor shall have no further obligation to support Licensee in its interactions with any Regulatory Authority. b) Licensee shall notify the Licensor Alliance Manager promptly (but in no event later than two (2) Business Days) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such times as may be requested notice the reasoning behind such determination, and any supporting facts. Licensee (or its 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 recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Licensee (or its Affiliate or Sublicensee) shall initiate such Regulatory Authorities a recall, market suspension, or market withdrawal in compliance with respect Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to the Core Development Activities (“Regulatory Activities”this Section 3.2.1.b), provided that KHK will have primary responsibility for obtaining, and UGNX Licensee (or its Affiliate or Sublicensee) shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals be solely responsible for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, execution 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 Fieldthereof.