Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. In addition to its overall responsibilities set forth in Section 4.3(a), the JTT shall in particular: (i) oversee the execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition activities of the Parties under this Agreement, the Transition Plan, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC); (ii) review, at least […***…], the Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by the JTT; (iii) review and approve any amendments, modifications or changes to the Transition Plan, the Development activities contemplated by the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze a material breach by any Party (if referred to it by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional working groups as it deems necessary to achieve the foregoing objectives; (ix) discuss compliance issues arising under this Agreement or the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussions; and (x) prior to the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided that, in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…].

Specific Responsibilities. In addition Subject to its overall responsibilities set forth in Section 4.3(a)the oversight of the JEC [*], the JTT shall JDC shall, in particular, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable: (i) oversee with input from the execution of CFDT or the Transition Plan Regional Operating Committees, as appropriate, reviewing and discussrecommending, monitorfor approval by the JEC, coordinate and provide the necessary support for the Transition activities of the Parties under this Agreement, the Transition each Long-Term Development Plan, the each Annual Development Plan and Budget for the Collaboration Compounds and Products, and all material changes to the Shared Territory Commercialization Annual Development Plan and Budget (other than […***…]recommended by the CFDT or the Regional Operating Committees made during the course of a Year, which remain under subject, if applicable, to the purview requirement of Joint Committee Consent or Party Written Consent to the JDCextent required by Section 3.2(b); (ii) reviewnot less often than semi-annually, at least […***…]reviewing the Long-Term Development Plan, which shall be submitted to the Shared Territory Commercialization Plan and Budget and suggest JEC for approval if an increase of more than ten percent (10%) in the total budgeted amount is involved or for any applicable amendments thereto non‑financial change that significantly affects the scope, science, timing or likelihood of success of the Development program for review and approval a Product, subject, if applicable, to the requirement of Joint Committee Consent or Party Written Consent to the extent required by the JTTSection 3.2(b); (iii) review (A) reviewing and approve any amendmentsendorsing, modifications or changes to for approval by the Transition PlanJEC, the Development activities contemplated by decision to file a DAA for the Development Plan first and Budget each subsequent indication (and all amendments and supplements to a DAA and the content of such filings to be made (other than routine reporting obligations, such as non-serious Adverse Event reports, unless there is a dispute […***…]] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. relating thereto)), (B) determining and approving Territory-wide regulatory strategies and guidelines, and (C) reviewing all key regulatory filings in the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to for consistency with Territory-wide regulatory strategy/guidelines approved by the JEC; […***…]; (iv) discuss monitoring Development activities, reviewing all significant information generated in the course of implementing each Long-Term Development Plan and analyze a material breach by any Party (if referred to it each Annual Development Plan and Budget and otherwise overseeing the implementation of each Long-Term Development Plan and each Annual Development Plan and Budget by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching PartyCFDT; (v) approve or consent reviewing and approving, with input from the CFDT, the scientific integrity, statistical analysis plans, and protocols (and any investigators’ brochure(s) and revisions thereto) of all Clinical Trials conducted in the Territory (it being understood that the JDC may delegate to any a working group established by the JDC (which shall operate by the procedures set forth in Section 2.10) the review and approval of such matters to avoid inappropriate delay); provided, that once such scientific integrity of a Phase IV Clinical Trial is approved, JDC approval shall not be required under this Agreement paragraph for a subsequent Phase IV Clinical Trial that require uses substantially the approval or consent of the JTTsame protocol as that previously approved; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budgetdetermining at each Decision Point, if requested by a Partyany, whether the Development activities to which such Decision Point pertains have satisfied the corresponding Success Criteria, if any, and advise the JEC and the Parties in writing of such findings no later than thirty (30) days following the applicable Decision Point, which writing shall set forth in detail the basis for such determination; (vii) attempt to resolve reviewing and approving any disputes referred to it by significant agreements, including any Country Transition Teams pursuant to Section 4.5(a) agreement with an aggregate expense of more than [*] (or such other amount as may be specified by the Functional TeamJEC from time to time), with Third Parties to be entered into by either or both Parties relating to the Development of a Collaboration Compound or Product, or any disputes that such other threshold to which the Parties may arise out agree by mutual Party Written Consent or Joint Committee Consent of Galapagos’ exercise of its General Direction pursuant to Section 4.10the JEC; (viii) establish unless and to the extent delegated to the CFDT, reviewing and approving the content, strategies for, and other aspects (other than level of funding) for (A) Product labeling, (B) early access and compassionate use programs in a country for a given indication (i.e., prior to Launch in such additional working groups as it deems necessary to achieve the foregoing objectivescountry for such indication), (C) Medical Education Activities, and (D) pediatric exclusivity extension Clinical Trials; (ix) discuss compliance issues unless and to the extent delegated to the CFDT, approving the content, strategies for, and other aspects (other than level of funding) for investigator sponsored clinical studies; (x) assisting in coordinating scientific interactions and resolving disagreements between BMS and COLLABORATOR during the course of implementing each Long-Term Development Plan and Annual Development Plan and Budget; [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. (xi) approving (A) a regulatory strategy plan for obtaining Approvals and matters relating thereto; (B) publication strategies for data arising under this Agreement out of Clinical Trials; and (C) significant post-Approval filings and submissions to the applicable Regulatory Authorities (including supplements and amendments to Approvals); (xii) reviewing and approving guidelines for the allocation by the CFDT or the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided thatRegional Operating Committees of responsibilities for Development activities between BMS and COLLABORATOR, day-to-day discussions will be had by the Transition Compliance Working Group in accordance consistent with Section 4.4(b). When dealing 2.13; (xiii) subject to Section 3.7, with input from the CFDT and the ROCs, making recommendations to the JEC concerning whether to seek new indications, formulations or uses for the Collaboration Compounds and Products, such compliance issues, as for Product life cycle management; (xiv) reviewing and approving a patient risk management strategy and plan for the JTT will invite representatives with relevant compliance knowledge Products; (xv) overseeing the regulatory functions and expertise actions of the CFDT and the ROCs; (xvi) performing such other duties as are expressly assigned to the JDC in this Agreement; (xvii) performing such other functions as the JEC may request from both Parties time to participate in the discussionstime; and (xxviii) prior providing Quarterly updates on its activities and achievements to the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided that, in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]JEC.

Specific Responsibilities. In addition Subject to its overall responsibilities set forth in Section 4.3(a)the oversight of the JEC [*], the JTT shall JCC shall, in particular, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable: (i) oversee reviewing and recommending for approval by the execution of JEC the Transition Plan and discuss, monitor, coordinate and provide the necessary support Territory-wide Commercial strategy for the Transition activities Collaboration Compounds and Products; [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Parties under this Agreement, the Transition Plan, the Development Plan Securities and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC);Exchange Commission. (ii) reviewreviewing, at least […***…]with input from the CFDT and the Regional Operating Committees, the Shared Territory Commercialization Plan as appropriate, and Budget approving Territory-wide Product positioning, messaging, branding and suggest any applicable amendments thereto for review and approval by the JTTreimbursement strategies; (iii) review with input from the CFDT or the Regional Operating Committees, as appropriate, reviewing and approve any amendments, modifications or changes to the Transition Plan, the Development activities contemplated recommending (under guidelines developed by the Development Plan and Budget (other than […***…]Parties’ counsel), for approval by the Shared Territory Commercialization Plan JEC, a range of suggested prices and Budget discount strategies for a Product, for use Territory-wide, or any other Commercialization plan applicable to […***…]where appropriate, in a Region and/or in country in the Territory; (iv) discuss subject to Section 3.7, with input from the CFDT, and analyze a material breach by any Party (if referred in consultation with the JDC, making recommendations to it by the non-breaching Party)JEC concerning whether to seek new indications, determine formulations or uses for the Collaboration Compounds and approve any Remedial Measures to be imposed on Products in the Territory, such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Partyas for Product life cycle management; (v) approve or consent to any matters under this Agreement that require reviewing and recommending for approval by the approval or consent of the JTTJEC Territory-wide marketing budgets; (vi) prior to approving, following consideration of the Initial Transition Daterecommendations of the CFDT and after consultation with the SCC, prepare, review packaging designs and approve a Joint Development Plan and Budget, if requested by a PartyProduct Trademarks for use in the Territory; (vii) attempt to resolve any disputes the extent referred to it by any Country Transition Teams pursuant to Section 4.5(a) or the JCC by the Functional TeamCFDT or the applicable ROC, or reviewing each Long-Term Commercialization Plan and each Annual Commercialization Plan and Budget for consistency with strategies and guidance adopted in clauses (i), (ii), (iii) and (vi) of this Section 2.4(b) and presenting to the JEC for resolution any disputes inconsistencies noted that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10cannot be resolved by discussion with the applicable ROC; (viii) establish performing such additional working groups other duties as it deems necessary are expressly assigned to achieve the foregoing objectivesJCC in this Agreement; (ix) discuss compliance issues arising under this Agreement or performing such other functions as the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise JEC may request from both Parties time to participate in the discussionstime; and (x) prior providing Quarterly updates on the JCC’s activities and achievements to the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided that, in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]JEC.

Specific Responsibilities. In addition The JSC shall have the following responsibilities with respect to its overall responsibilities set forth in Section 4.3(a)the Project generally, the JTT shall in particularProject Plan, and to the Assay and the IVD Kit: (i) oversee Oversee the execution progress of the Transition Plan Activities under the Project and discuss, monitor, coordinate and provide facilitate the necessary support for the Transition activities exchange of information between the Parties under this Agreement, during the Transition Plan, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC);Term; ​ 1. ​ ​ (ii) reviewReview quarterly progress reports under the Project and Project Plan, at least […***…]as well as quarterly updates on regulatory activities (including the Regulatory Approval process and timelines), the Shared Territory Commercialization Plan communications and Budget and suggest any applicable amendments thereto for review and approval by the JTTcoordination. Each Party shall deliver such reports to JSC on a timely manner; (iii) review Review and approve any amendments, modifications or scope changes as described in Section 2.2 to the Transition Plan, the Development activities contemplated by the Development Project Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]timelines therefor; (iv) discuss Maintain the list of Target Countries and analyze a material breach make modifications thereto upon APR’s notification and upon the appropriate adjustments in the Budget and Pass Through Expenses pursuant to Section 3.6. For clarity, Target Countries shall be determined by any Party (if referred APR and not the JSC, but subject to it by agreement on the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Partyamended Budget as provided in Section 3.6; (v) approve or consent to any matters under this Agreement that require Align strategy and timing for the approval or consent Regulatory Approval of the JTTAssay and IVD Kit (including the labeling thereof) with the regulatory strategy and timing for the APR Product (including the labeling thereof); provided that the regulatory strategy for the APR Product (including the labeling thereof) shall be solely determined by APR, as set forth in Section 4.1; (vi) prior to the Initial Transition Date, prepare, Annually review and approve a Joint Development modify the Project Plan (including timelines) and Budget, if requested by a PartyBudget (including appropriate adjustments to reflect costs for Regulatory Approval of the Assay and/or the IVD Kit arising from newly identified and/or changes to Target Countries); (vii) attempt Establish, monitor and delegate duties to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Teamother committees, subcommittees, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant directed teams (each a “Working Group”) on an “as needed” basis to Section 4.10oversee particular projects or activities, including the Joint Development Committee (the “JDC”), which is described below; (viii) establish such additional working groups as it deems necessary to achieve Hear and resolve disputes of the foregoing objectivesWorking Groups, including the JDC; (ix) discuss compliance issues arising under this Agreement or the Transition Ancillary Agreements that would conflict with Approve all Pass-Through Expenses in excess of $[…***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussionstotal; and (x) prior Taking such other actions as may be specifically allocated to the last MA Transfer Completion Date JSC by the Parties from time to occurtime; Each Party shall retain the rights, review powers and approve Galapagos Public Communicationsdiscretion granted to it under this Agreement and no such rights, as need be; powers or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided that, for in case of any Galapagos Public Communication that is required by Applicable Law this Agreement or the rules Parties expressly so agree in writing. For the avoidance of a stock exchange on which doubt, APR shall be solely responsible for the securities performance of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval all clinical trials of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]APR Product.

Specific Responsibilities. In addition to its overall responsibilities set forth in Section 4.3(a)responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JTT JSC shall in particular: (i) oversee the execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition collaborative activities of the Parties under this Agreement, create and review the Transition Planoverall strategy for Developing and seeking Regulatory Approval for, Manufacturing, and Commercializing Collaboration Products, in the Development Plan and Budget and Field in the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC)Territory; (ii) review, at least […***…]receive and discuss reports from the JDC, the Shared Territory JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan Plan(s) (including the Commercialization Budget(s)), and Budget and suggest any applicable amendments thereto for review and approval by the JTTthereto; (iii) review and approve any amendments, modifications or changes to the Transition Plan, the Development activities contemplated by the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze a material breach by any Party (if referred to it by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional working groups joint subcommittees as it deems necessary to achieve the foregoing objectivesobjectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan [ * ] with associated budget, resource allocation and regulatory plans; (ix) discuss compliance issues arising under this Agreement review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the Transition Ancillary Agreements that would conflict portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issuesspecific responsibilities of the JDC, the JTT will invite representatives JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with relevant compliance knowledge and expertise from both Parties respect to participate in the discussionsCollaboration Product; and (xxii) prior perform such other functions as appropriate to further the last MA Transfer Completion Date purposes of this Agreement as allocated to occur, review and approve Galapagos Public Communications, as need be; provided that, it in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to writing by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]Parties.

Specific Responsibilities. In addition to its overall responsibilities set forth in Section 4.3(a)responsibility for the Collaboration, [*], the JTT shall JEC shall, in particular:, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable: [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. (i) oversee approving all key regulatory and Development actions with respect to any country in the execution of the Transition Plan and discussTerritory, monitor, coordinate and provide the necessary support including (A) Product labeling for the Transition activities of the Parties under this Agreementfirst and each subsequent indication and any other material changes or supplements thereto in each Region and (B) life cycle management decision or plans for a Product, the Transition Planincluding whether to seek new formulations, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…]indications, which remain under the purview of the JDC)or uses for a Product; (ii) reviewapproving a range of suggested prices and discount strategies for a Product, at least […***…], the Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by the JTTuse Territory-wide or in a Region; (iii) review directing and approve any amendments, modifications or changes to overseeing the Transition Plan, various Committees on all significant strategic issues that fall within the Development activities contemplated by purview of the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]various Committees; (iv) discuss approving (A) each Territory-wide Long-Term Development Plan, (B) each Territory-wide Annual Development Plan and analyze Budget, (C) each Pre-Launch Commercialization Plan and Budget for each Region, (D) each Territory-wide Long-Term Commercialization Plan, (E) each Annual Commercialization Plan and Budget for each Region, and (F) any amendments and modifications to such plans and budgets that involve material changes to funding levels or the Parties’ resource commitments; (v) coordinating the activities of the Parties hereunder, including facilitating communications between the Parties with respect to the Development and Commercialization of the Collaboration Compounds and Products; (vi) receiving updates and reports on the activities and achievements of the other Committees and reviewing and commenting on the progress of the other Committees; (vii) providing a material breach forum for dispute resolution as provided in Section 2.10(c); (viii) subject to Section 5.5, Article 9 and Section 13.1(d), with input from the Intellectual Property Operating Committee, reviewing and approving strategies for obtaining Patent and Product Trademark protection for each Product, for enforcing such Patents and Trademarks, and for defending Third Party claims relating to Patents and Trademarks in the Territory, subject to the terms and conditions of this Agreement; provided, that in the event of a dispute in the JEC concerning such matters, [*]; (ix) subject to Section 5.5 and with input from the Intellectual Property Operating Committee, reviewing and approving the terms of any Third Party license agreement to be entered into after the Execution Date with respect to Third Party intellectual property relating to the Development, manufacture, or Commercialization of a Product in the Territory; [*] (x) with input from the CFDT, approving patient assistance programs, vendor return policies and indigent access programs recommended by any Party the ROCs; [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. (if xi) reviewing, resolving, and/or approving such matters as are referred to it by the non-breaching Party)Alliance Managers, determine and approve JFC, JDC, JCC, CFDT or any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching PartyROC; (vxii) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior performing such other duties as are expressly assigned to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional working groups as it deems necessary to achieve the foregoing objectives; (ix) discuss compliance issues arising under JEC in this Agreement or the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussionsAgreement; and (xxiii) prior performing such other functions as appropriate to further the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided that, in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval purposes of the JTTCollaboration, consistent with this Agreement, and (3) Galapagos shall not such other responsibilities as may be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]Parties by mutual Party Written Consent.

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In addition particular, the JRC shall: (a) serve as a discussion forum in relation to its overall responsibilities set forth in Section 4.3(apotential Modulator Targets and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targets, if any) during any period when the Parties have not elected to appoint a Gatekeeper; (b) periodically (no less often than [***]) review and serve as a forum for discussing the Discovery Research Plan for each Collaboration Target, and review and approve any amendments thereto; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the JTT shall achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in particular:the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) oversee serve as a forum for discussion of results from the execution conduct of the Transition Plan Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discuss, monitor, coordinate discovery and provide the necessary support for the Transition activities of the Parties other JRC related information and Know-How as contemplated under this Agreement, the Transition Plan, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC); (iil) reviewmonitor and implement the transfer of CMC materials to Genentech, at least […***…], the Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by the JTTwhether pursuant to Section 5.3 or Section 5.4; (iiim) review monitor and approve any amendments, modifications or changes implement the technology transfer to the Transition Plan, the Development activities contemplated by the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze a material breach by any Party (if referred to it by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams Genentech pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional working groups as it deems necessary to achieve the foregoing objectives; (ix) discuss compliance issues arising under this Agreement or the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussions5.4; and (xn) prior to the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, perform such other functions as need be; provided that, in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth herein or as the Parties may mutually agree in Section 9.1(g)writing, except to the extent such activities materially adversely affect the Exploitation where in conflict with any provision of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]this Agreement.

Specific Responsibilities. In addition to its overall responsibilities set forth in Section 4.3(a)responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JTT JSC shall in particular: (i) oversee the execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition collaborative activities of the Parties under this Agreement, the Transition Plan, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC); (ii) review, at least […***…], the Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by discuss the JTTDevelopment and Commercialization of Products and any other ongoing activities; (iii) review and approve any amendments, modifications determine whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or changes to the Transition Plan, the Development activities contemplated by the Development Plan and Budget [*] Indication (other than but not […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze determine whether to select as the formulation for the MDV3100 Product for which approval of the NDA will be sought, either the formulation used for the Initial MDV3100 Product or a material breach by any Party [*] used for a [*] MDV3100 Product (if referred to it by being understood that the non-breaching PartyJSC will select the [*] that is in the best interest of the Product with the goal of maintaining the [*] agreed upon in the Joint Development Plan for [*]), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require review and discuss reports from the approval or consent JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the JTTInitial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan discuss strategies for obtaining, maintaining, defending and Budget, if requested by a Partyenforcing patent and trademark protection for Products within the Territory; (vii) attempt to resolve any disputes referred issues presented to it by any Country Transition Teams pursuant to Section 4.5(a) or by by, and disputes within, the Functional TeamJDC, JMC, JMAC, JCC, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10other subcommittee; (viii) determine whether the conduct and oversight of a Voluntary Phase 4 Clinical Trial should be undertaken by the JDC instead of the JMAC; (ix) establish such additional working groups joint subcommittees as it deems necessary to achieve the foregoing objectives; (ix) discuss compliance issues arising under objectives and intent of this Agreement or Agreement; and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis securities and exchange commission pursuant to rule 24b-2 of the securities exchange act of 1934, as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussions; andamended. (x) prior perform such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, to further the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided thatpurposes of this Agreement, in each case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products as agreed in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to writing by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]Parties.

Specific Responsibilities. In addition to its overall responsibilities set forth in Section 4.3(a)responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JTT JSC shall in particular: (i) oversee the execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition collaborative activities of the Parties under this Agreement, create and review the Transition Planoverall strategy for Developing and seeking Regulatory Approval for, Manufacturing, and Commercializing Collaboration Products, in the Development Plan and Budget and Field in the Shared Territory Commercialization Plan and Budget (other than […***…], which remain under the purview of the JDC)Territory; (ii) review, at least […***…]receive and discuss reports from the JDC, the Shared Territory JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan Plan(s) (including the Commercialization Budget(s)), and Budget and suggest any applicable amendments thereto for review and approval by the JTTthereto; (iii) review and approve any amendments, modifications or changes to the Transition Plan, the Development activities contemplated by the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze a material breach by any Party (if referred to it by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional working groups joint subcommittees as it deems necessary to achieve the foregoing objectivesobjectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan [*] with associated budget, resource allocation and regulatory plans; (ix) discuss compliance issues arising under this Agreement review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the Transition Ancillary Agreements that would conflict portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by ]; (x) review and approve any changes to the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issuesspecific responsibilities of the JDC, the JTT will invite representatives JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with relevant compliance knowledge and expertise from both Parties respect to participate in the discussionsCollaboration Product; and (xxii) prior perform such other functions as appropriate to further the last MA Transfer Completion Date purposes of this Agreement as allocated to occur, review and approve Galapagos Public Communications, as need be; provided that, it in case of any Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any issues related to such activities not agreed to writing by the JTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…]Parties.