Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. The JDC shall develop the strategies for and oversee the Development of the Licensed Compounds or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shall: (i) periodically […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment; (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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. (iv) determine whether a Compound Failure has occurred; (v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; (vi) periodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any; (vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Section 2.2.2

Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to by the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that with respect to in person meetings, unless otherwise agreed the location of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the strategies for and oversee the Development of the Licensed Compounds Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Compounds Antibodies or Licensed Products for the Territory. In particular, the JDC shall: (ia) periodically […***…] (no less often than annually) review and serve as a forum for discussing the Initial each Pre Exercise Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment;which approval will be reflected in the applicable minutes of the JDC meeting; *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iiib) serve as a forum for discussing and coordinating oversee the conduct of Pre Exercise Development Activities; (c) periodically (no less often than annually) review and approve each Post Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; (d) serve as a forum for discussing the conduct of the applicable Country-Specific Development Activities; (e) serve as a forum for discussing and oversee the conduct of Additional Licensor Development Activities; (f) serve as a forum for reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory; 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. (iv) determine whether a Compound Failure has occurred; (vg) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement;; and (vih) periodically (no less often than annually) review and serve perform such other functions as a forum for discussing and planning are set forth herein or as the communicationParties may mutually agree in writing, publication, abstract or presentation plan and activities, if any; (vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve except where in conflict with any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes provision of this Section 2.2.2Agreement.

Specific Responsibilities. The JDC shall develop the strategies for manage, coordinate and oversee the Parties’ activities under the Potentiator POC Development of Plan, the Licensed Compounds or Licensed Products in Corrector/Combination Product POC Development Plan, the TerritoryPost-POC Development Plans, and shall serve as a forum for the coordination of Galapagos Territory Development activities for the Licensed Compounds or Licensed Products for the TerritoryPlan. In particular, the JDC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically […***…] (no less often than semi-annually) review and serve as a forum for discussing discussing, as applicable, the Initial Potentiator POC Development Plan Plan, the Corrector/Combination Product POC Development Plan, and Budget, such review to include oversight of project risk and mitigation strategiesthe Post-POC Development Plans, and review and approve amendments thereto, including any Material Amendmentamendments to the POC Budgets and Post-POC Development Budgets; (iiiii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria; (v) determine whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteria; (vi) oversee the conduct of Development activities activities, as applicable, under the Initial Potentiator POC Development Plan Plan, the Corrector/Combination Product POC Development Plan, and Budgetthe Post-POC Development Plans; (iiivii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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.; (ivviii) determine whether the Development activities under a Compound Failure has occurredPost-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (vix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other JDC Development-related Information as contemplated under this Agreement; (vixiii) periodically (no less often than annually) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any;performance of all such Third Party Providers; and (viixiv) periodically review and serve perform such other functions as a forum for discussing are set forth herein or as the […***…] Development Plan or RA Phase 3 Development PlanParties may mutually agree in writing, as applicable; (viii) approve except where in conflict with any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes provision of this Section 2.2.2Agreement.

Specific Responsibilities. The JDC shall develop the strategies for and oversee the Development of the Licensed Compounds or Licensed Products in the TerritoryLicensee Territory and the United States, and shall serve as a forum for the coordination of Development activities for the Licensed Compounds or Licensed Products for the TerritoryLicensee Territory and the United States. In particular, the JDC shall: (i) periodically ([…***…] ]) review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategiesPlan, and review and approve amendments thereto, including any Material Amendment; (ii) serve as a forum for discussing proposed Joint Development Activities and Proposed Unilateral Activities; (iii) periodically ([***]) review each Development Plan and Budget for Joint Development Activities and Unilateral Activities, and review and approve amendments thereto; (iv) resolve any disputes regarding whether any Proposed Unilateral Activities, proposed Phase IV Studies, or proposed regulatory action could have a Material Adverse Effect on a Party; (v) periodically review and serve as a forum for discussing Collaboration Candidate Development Plans and Budgets, and review and approve amendments thereto; (vi) periodically review the conduct of Development activities under each Collaboration Candidate Development Plan and Budget; (vii) oversee the conduct of Development activities under the Initial Development Plan and BudgetPlan; (iiiviii) oversee the conduct of Joint Development Activities and Unilateral Activities; (ix) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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.Licensee Territory and the United States; (ivx) determine whether a Compound Failure has occurred;; and (vxi) establish secure access methods (such as secure databases) for each Party to access the other Party’s Regulatory Documentation and other JDC related Information as contemplated under this Agreement;; and (vixii) periodically (no less often than annually) review and serve perform such other functions as a forum for discussing and planning are set forth herein or as the communicationParties may mutually agree in writing, publication, abstract or presentation plan and activities, if any; (vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve except where in conflict with any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes provision of this Section 2.2.2Agreement.

Specific Responsibilities. The JDC shall develop JRDC will, subject to the strategies escalation, final decision-making authority and dispute resolution procedures in Section 9.9: (a) be responsible for overseeing the Parties’ performance of their respective activities under the Research Plan and oversee Early Development Plan and provide support to each Party with respect to such Party’s activities thereunder; (b) review and discuss each amended Research Plan and Early Development Plan and approve updates or material amendments to the Research Plan and the Early Development Plan; (c) discuss and determine whether a Degrader that is Researched under this Agreement meets the Screening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria; (d) review, discuss and approve changes to the Screening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria; (e) discuss and determine whether Successful Completion has been achieved; (f) review and discuss the list of Degraders provided by Kymera pursuant to Section 2.2.2; (g) review and discuss reports and data provided by Kymera pursuant to Section 2.4.4 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the First Additional Degrader Criteria; (h) cause the minutes of the Licensed Compounds or Licensed Products in the Territory, and shall serve JRDC to reflect any selection of a Degrader as a forum for First Additional Degrader, whether by the coordination of Development activities for the Licensed Compounds or Licensed Products for the Territory. In particularJRDC, the JDC shall:R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.4; (i) periodically review, discuss and determine […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment]; (iij) oversee the conduct of Development activities under the Initial Development Plan review, discuss and Budgetdetermine [***]; (iiik) serve as a forum for discussing review, discuss and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “approve [...***...]”. 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.; (ivl) following [***], discuss and determine [***]; (m) review, discuss and determine whether a Collaboration Candidate or Licensed Product Directed Against Collaboration Target 2 satisfies the Phase 1 Ready Criteria; (n) review and discuss reports and data provided by Kymera pursuant to Section 2.5.6 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Second Additional Degrader Criteria; (o) cause the minutes of the JRDC to reflect any selection of a Degrader as a Second Additional Degrader, whether by the JRDC or the R&D Expert or by Sanofi in accordance with Section 2.5.6; (p) review and discuss reports and data provided by Kymera pursuant to Section 2.6.5 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the ▇▇ ▇▇▇▇▇▇▇▇; (q) cause the minutes of the JRDC to reflect any selection of a Collaboration Compound Failure has occurredas a Collaboration Candidate, whether by the JRDC or the R&D Expert; (r) review and discuss information provided by Kymera pursuant to Section 2.5.4 and whether to approve any related overspend as a Permitted Overrun; (s) review, discuss and approve a Research Budget Excession in accordance with Section 2.5.4, including whether any such Research Budget Excession was in Kymera’s reasonable control; (t) review, discuss and determine whether Research Activities under Section 2.6.3 should be discontinued; (u) review and discuss information provided by Kymera pursuant to Section 2.6.4 and whether to approve any related overspend as a Series 2 Permitted Overrun; (v) establish secure access methods (review, discuss and approve Series 2 Research Budget Excession in accordance with Section 2.6.4, including whether any such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementSeries 2 Research Budget Excession was in Kymera’s reasonable control; (viw) periodically discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 2.8 and discuss information provided by a Party with respect to MTA Research Studies; (no less often than annuallyx) during the Research Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 2, determine the first Indication for which the first IND will be filed with respect to a Licensed Product; (y) discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 3.5 and discuss information provided by a Party with respect to MTA Development Studies; (z) review and serve as discuss reports provided by a forum for discussing and planning the communicationParty pursuant to Section 2.11, publication, abstract Section 3.7 or presentation plan and activities, if anySection 5.5; (viiaa) periodically to the extent contemplated by Section 5.2.3, review, discussion and approve an extension of time during which Kymera will make its personnel reasonably available; (bb) review and serve discuss information provided by Kymera pursuant to Section 5.5.6 and whether to approve any related overspend as a forum for discussing the Permitted Backup Research Overrun; (cc) review, discuss and determine, in accordance with Section 5.5.6, whether any Backup Research Budget Excession was in Kymera’s reasonable control; (dd) review and discuss reports and data provided by Kymera pursuant to Section 5.5.7 within […***…] Development Plan or RA Phase 3 Development Planafter the delivery of each such report, as applicableand determine if a relevant Degrader satisfies the Backup Degrader Criteria; (viiiee) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection cause the minutes of the subcontractor within […***…] from JRDC to reflect any selection of a Degrader as a Backup Degrader, whether by the date JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 5.5.10; (ff) in coordination with the JPC, review and discuss any requests by Kymera pursuant to Section 5.6.5 regarding a potential reversion of request any Collaboration Compounds or Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by Ablynx. In or on behalf of Kymera under Section 2.3, 2.4, 2.5 or 5.5 but have not been selected as the event AbbVie does not provide notice within such […***…] periodFirst Additional Degraders, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Second Additional Degraders or Backup Degraders; (gg) review and discuss reports provided by Sanofi in accordance with Section 13.9, for purposes of this Section 2.2.25.9;

Specific Responsibilities. The JDC JCC shall develop the strategies for and oversee the Development Commercialization of the Licensed Compounds or Licensed Co-Promotion Products in the Territory, Co-Promotion Territory and shall serve as oversee at a forum for high level all Commercialization activities in the coordination of Development activities for Galapagos Territory with respect to the Licensed Compounds or Licensed Products for the TerritoryProducts. In particular, the JDC JCC shall: (i) periodically […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment; (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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. (iv) determine whether a Compound Failure has occurred; (v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; (vi) periodically (no less often than annually) review and serve as a forum for discussing AbbVie’s Commercialization activities in the AbbVie Territory and planning AbbVie’s global brand plan for the communicationProducts, publicationincluding marketing and promotional materials, abstract or presentation plan Product messaging, Commercialization budgets and activities, if anyDetailing effort; (viiii) establish a strategy for the Commercialization of the Co-Promotion Products in the Co-Promotion Territory; (iii) review and approve the initial Co-Promotion Plan; (iv) periodically (no less often than annually) review and serve as a forum for discussing the […***…] Development Co-Promotion Plan or RA Phase 3 Development Plan, as applicableand review and approve amendments thereto; (viiiv) review and approve any subcontractors that Ablynx may utilize the manner in any interactions with a Regulatory Authoritywhich the Markings are to be presented on promotional materials and Product Labeling for the Co-Promotion Products in the Co-Promotion Territory; (vi) review and approve the initial Galapagos Territory Commercialization Plan; provided, that AbbVie shall provide notice ensure that its representatives on the JCC do not unreasonably withhold such approval so long as the initial Galapagos Territory Commercialization Plan is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of this Agreement; (vii) oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products; (viii) periodically (no less often than annually) review and serve as a forum for discussing the Galapagos Territory Commercialization Plan and its implementation, and review and approve any amendments thereto; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval or rejection so long as such amendment is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of this Agreement; (ix) review and approve the subcontractor within form and content of all marketing and promotional materials and all Product messaging to be used in the Galapagos Territory with respect to the Products; * Confidential information, indicated by […...***…] ...], has been omitted from this filing and filed separately with the date U.S. Securities and Exchange Commission. (x) review and approve the form and content of request by Ablynx. In all training materials to be used in the event AbbVie does not provide notice within Galapagos Territory with respect to the Products; (xi) discuss the selection of all Distributors and Third Party co-promoters and promoters engaged to support Commercialization activities in the Galapagos Territory and review the performance of all such […***…] periodThird Parties; and (xii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes except where in conflict with any provision of this Section 2.2.2Agreement.

Specific Responsibilities. The JDC JSC shall develop continuously monitor the strategies for and oversee progress of the Development Plan and Budget and provide status reports to the senior management of each of the Parties as appropriate. The Parties contemplate that the responsibilities of the Joint Steering Committee shall evolve during the course of the Parties’ relationship under this Agreement. In support of its responsibility for overseeing and coordinating the Development and Exploitation of the Licensed Compounds Products, the JSC shall: (a) establish a strategy for (i) the Development, Approval, Commercialization and other Exploitation of the Licensed Products in (A) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Salix Human Excluding HIV/AIDS/ID/Pediatric Territory; (B) the HIV/AIDS/Pediatric Field in the Salix HIV/AIDS/Pediatric Territory; and (C) the ID Field in the Salix ID Territory and (ii) the coordination of the Development, Approval, Commercialization and other Exploitation of the Licensed Products in fields and countries other than those specified in the preceding clause (i) to the extent such Development, Approval, Commercialization and other Exploitation impacts or affects the Development, Approval, Commercialization and other Exploitation of the Licensed Products in the Territory, fields and shall serve as a forum for the coordination of Development activities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shall:countries specified in clause (i); (ib) periodically […***…] review and serve as a forum for discussing monitor the Initial Development Plan and BudgetBudget and the implementation thereof and make recommendations to the Parties regarding updates, such review amendments and modifications to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment; (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iiic) serve as a forum consider the allocation of responsibilities between the Parties for discussing Development pursuant to the Development Plan and coordinating strategies Budget; (d) consider the allocation of responsibilities between the Parties for obtaining Commercialization and other Exploitation activities pursuant to one or more written plans covering the Commercialization and other Exploitation of each Licensed Product; (e) review and make recommendations to the Parties regarding the conduct of Clinical Trials for additional indications for Licensed Products, Post Approval Studies for Licensed Products, and amendments to the Development Plan and Budget in respect thereof; (f) review statistical analysis plans and protocols for, and monitor the progress of, all Clinical Trials and Post Approval Studies for the Licensed Products; (g) review and make recommendations to the Parties on all proposed product labeling, Drug Approval Applications and other filings with the Regulatory Authorities with respect to Approvals for the Licensed Products in the Territory; 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. (iv) determine whether a Compound Failure has occurredProducts; (vh) establish secure access methods (such as secure databases) review and make recommendations to the Parties on advertising and promotional materials and strategies, packaging designs and Product Trademarks for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementLicensed Product; (vii) periodically (no less often than annually) review facilitate the exchange of Development Information relating to all Clinical Trials and serve as a forum Post Approval Studies and Commercialization Information for discussing and planning the communication, publication, abstract or presentation plan and activities, if anyLicensed Products; (viij) periodically review establish such other committees (each, including the JSC, a “Committee”) as deemed appropriate by the JSC, including such Committees as the JSC deems appropriate to coordinate the Development, Approval, Commercialization and serve as other Exploitation of the Licensed Products on a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicableworldwide basis; (viiik) approve any subcontractors that Ablynx consider labeling issues and undertake coordination of labeling on a worldwide basis so as to ensure such degree of consistency in labeling as the JSC deems to be desirable; and (l) perform such other functions as are set forth herein or as the Parties may utilize mutually agree in any interactions with a Regulatory Authority; providedwriting. For clarity, that AbbVie shall provide notice of approval or rejection of subject to the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes terms of this Section 2.2.2Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.

Specific Responsibilities. The JDC shall develop the strategies for and oversee the Development of the Licensed Compounds or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shallwill: (i) periodically […***…] review facilitate the flow of information between the Parties with respect to the Development and serve as a forum for discussing Commercialization of the Initial Development Plan Licensed Antibodies and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material AmendmentLicensed Products; (ii) oversee the conduct of Development activities under the Initial review, discuss, and determine whether to approve updates to any Ongoing JS001 Development Plan or Ongoing JS001 Development Budget pursuant to Section 4.2(a) (Plans and BudgetBudgets); (iii) serve as a forum for discussing review and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territorydiscuss Development Proposals presented by either Party pursuant to Section 4.3(a) (Proposals and JDC Review), and, subject to Section 3.2(b)(iv), Independent Trials, Independent Development Plans, and Independent ​ ​ ​ Development Budgets presented by either Party pursuant to Section 4.5 (Independent Development); 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.​ (iv) review, discuss, and determine whether to approve each Joint Development Plan and Joint Development Budget, and each update thereto, pursuant to Section 4.4 (Joint Development), which will include any Independent Development Plan or Independent Development Budget that becomes a Compound Failure has occurred;Joint Development Plan or Joint Development Budget following a Party’s opt-in pursuant to Section 4.5 (Independent Development), and any updates thereto; ​ (v) establish secure access methods after the Option Exercise with respect to an Option Program, review, discuss, and determine whether to approve all updates or amendments to any applicable Optioned Licensed Product Trials, Optioned Licensed Product Development Plan, and Optioned Licensed Product Development Budget pursuant to Section 4.6 (such as secure databasesDevelopment of Optioned Licensed Products) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreementor Section 2.8 (Coherus License Options); (vi) periodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if anydiscuss any Development reports provided by either Party pursuant to Section 4.10 (Development Reports); (vii) periodically review review, discuss, and serve as a forum for discussing determine whether to approve the […***…] Development Transition Plan or RA Phase 3 Development Plan, as applicablepursuant to Section 5.1 (Regulatory Responsibilities); (viii) review, discuss, and approve any subcontractors that Ablynx may utilize (A) the date by which the Parties will complete all transition activities to enable Coherus to assume regulatory responsibilities for the Licensed Antibodies and Licensed Products in any interactions with a Regulatory Authority; providedthe Coherus Territory (other than those related to the Junshi Clinical Trials), that AbbVie shall provide notice of approval or rejection and (B) whether Coherus will assume responsibility for further regulatory activities for the Licensed Antibodies and Licensed Products throughout the Coherus Territory for the Ongoing JS001 Trial following transfer of the subcontractor within […***…] from applicable Regulatory Approvals and Regulatory Materials for the date Ongoing JS001 Trial to Coherus, in each case ((A) – (B)) pursuant to Section 5.2 (Assignment of request Regulatory Materials); (ix) review and discuss any Commercialization updates provided by Ablynx. In Coherus pursuant to Section 7.3 (Commercialization Report); (x) to the event AbbVie does extent not provide notice within specified in a Joint Development Plan approved by the JDC, review, discuss, and determine which Party will have control and decision-making authority with respect to preparing and submitting regulatory filings and conducting communications with Regulatory Authorities, in each case related to the Licensed Antibodies and Licensed Products that is the subject of the Joint Development Plan approved by the JDC, as applicable; and (xi) perform such […***…] periodother functions as appropriate, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for further the purposes of this Section 2.2.2Agreement, in each case as agreed in writing by the Parties.

Specific Responsibilities. The JDC shall develop the strategies for and oversee the Development of the Licensed Compounds or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shall: (i) periodically […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment; (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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.; (iv) determine whether a Compound Failure has occurred; (v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; (vi) periodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any;; 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. (vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Section 2.2.22.2.2(vii) AbbVie shall be permitted to provide notice via email; (ix) determine the appropriate timeline for the transfer of Regulatory Documentation, Ablynx Know-How, Joint Know-How and other Information from Ablynx to AbbVie pursuant to Section 3.5.4; and (x) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Specific Responsibilities. The JDC shall develop the strategies for manage, coordinate and oversee the Parties’ activities under the Combination Product POC Development of Plan, the Licensed Compounds or Licensed Products in Combination Product Post-POC Development Plan, the TerritoryCMC Plan, the Potentiator Post-POC Development Plan and shall serve as a forum for the coordination of Galapagos Territory Development activities for the Licensed Compounds or Licensed Products for the TerritoryPlan. In particular, the JDC shall: (i) develop and approve the Potentiator Post-POC Development Plan in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussing, as applicable, the Combination Product POC Development Plan, the Combination Product Post-POC Development Plan, and the Potentiator Product Post-POC Development Plan and review and approve amendments thereto, including any amendments to the Combination Product POC Budget, Combination Product Post-POC Development Budget and the Potentiator Post-POC Development Budget; (iii) determine the Corrector Molecules, Potentiator Molecules, Dual Combination Products and Triple Combination Products to be Developed in Phase 1s and Phase 2s under the Combination Product POC Development Plan; (iv) determine whether to discontinue (A) any Phase 1 or Phase 2 under the Combination Product POC Development Plan with respect to any particular Molecule or any particular Molecule(s) contained in a Combination Product or to select for Development in a Phase 1 or Phase 2 under the Combination Product POC Development Plan a new Molecule or a Combination Product containing one (1) or more new Molecules or (B) any Phase 2 under the Potentiator Post-POC Development Plan; * Confidential information, indicated by […...***…] ...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. (v) periodically (no less often than semi-annually) review and serve as a forum for discussing the Initial CMC Plan and review and approve CMC Amendments; (vi) determine whether any P+C1 Dual Combination Product satisfies the P+C1 Dual Combination Product POC Success Criteria; (vii) determine whether any Triple Combination Product satisfies the Triple Combination End of Phase 1 Success Criteria, Triple Combination Heterozygous Success Criteria, or Triple Combination Homozygous Success Criteria, as applicable; (viii) oversee the conduct of Development activities, as applicable, under the Combination Product POC Development Plan, the Combination Product Post-POC Development Plan, the Potentiator Post-POC Development Plan and Budget, such the CMC Plan; (ix) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (x) determine whether the Development activities under the Combination Product Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Combination Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Combination Product shall be made in any country or jurisdiction in the Territory; (xi) determine the occurrence of a Combination Post-POC Development Failure; (xii) determine whether the Development activities under the Potentiator Post-POC Development Plan support the filing of a Drug Approval Application for the Potentiator Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Potentiator Product shall be made in any country or jurisdiction in the Territory; (xiii) review to include oversight of project risk and mitigation strategiesapprove the initial Galapagos Territory Development Plan; (xiv) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto, including any Material Amendment; (ii) oversee the conduct of Development activities under the Initial Development Plan and Budget; (iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; 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. (iv) determine whether a Compound Failure has occurred; (vxv) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other JDC Development-related Information as contemplated under this Agreement; (vixvi) periodically (no less often than annually) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any;performance of all such Third Party Providers; and (viixvii) periodically review and serve perform such other functions as a forum for discussing are set forth herein or as the […***…] Development Plan or RA Phase 3 Development PlanParties may mutually agree in writing, as applicable; (viii) approve except where in conflict with any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes provision of this Section 2.2.2Agreement.