Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. The JCC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9: (a) review, discuss and approve the FTE Rate with respect to Co-Promote activities; (b) ensure that each Co-Promotion Plan allocates to the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s); (c) upon request of a Party, discuss the appropriate level of detail to include in a Co-Commercialization Budget; (d) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year; (e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Plan; (f) review and discuss reports provided pursuant to Section 6.8 or a Co-Promotion Agreement; (g) review, discuss and provide comments with respect to any promotional materials for the Co-Promotion of Opt-In Products; (h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailing; (i) oversee the Parties’ joint promotional efforts; (j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to; (k) review and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Products, including the identity of such agency and the material terms of such engagement; (l) establish the value of secondary position details, consistent with Sanofi’s then-current standard operating procedures; (m) establish benchmarks for the content and effectiveness of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s); (n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (p) determine the anticipated commercial launch date of each Opt-In Product; and (q) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

Specific Responsibilities. The JCC will, subject In addition to the escalation, final decision-making authority its overall responsibility for monitoring and dispute resolution procedures in Section 9.9: (a) review, providing a forum to discuss and approve coordinate the FTE Rate with respect to Co-Promote activities; (b) ensure that each Co-Promotion Plan allocates to Parties’ activities under this Agreement, the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s); (c) upon request of a Party, discuss the appropriate level of detail to include JSC shall in a Co-Commercialization Budget; (d) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year; (e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Plan; (f) review and discuss reports provided pursuant to Section 6.8 or a Co-Promotion Agreement; (g) review, discuss and provide comments with respect to any promotional materials for the Co-Promotion of Opt-In Products; (h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailing;particular: (i) oversee the Parties’ joint promotional effortscollaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = 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. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (jii) specify which commercial functional area experts receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives 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 managed careTRU-016) of Sanofi the Designated Sales Force will have access toand for which indications; (kvii) 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 discuss approve the engagement by Sanofi of a commercial advertising agency to be used in connection manufacturing plan for [ * ] and [ * ] or [ * ] with Detailing of the Opt-In Productsassociated budget, including the identity of such agency resource allocation and the material terms of such engagementregulatory plans; (lix) establish review and approve (A) inclusion of any costs not specifically enumerated in the value definitions of secondary position detailsDevelopment Costs or Commercialization Costs or any component thereof, consistent and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with Sanofi’s then-current standard operating proceduresrespect to the relevant Calendar Quarter by more than [ * ]; (mx) establish benchmarks for review and approve any changes to the content and effectiveness specific responsibilities of the principal promotional messages that are used by JDC, the Parties to promote JCC, the relevant Opt-In Product(s)JFC, and the JPC; (nxi) develop a Corrective Plan in discuss and make determinations regarding material safety issues with respect to the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (p) determine the anticipated commercial launch date of each Opt-In Collaboration Product; and (qxii) perform such other functions as are set forth in this Agreement, or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement. Any failure of Agreement as allocated to it in writing by the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9Parties.

Specific Responsibilities. The JCC willSteering Committee shall be responsible for facilitating the exchange of information regarding Licensed Compound and Licensed Product by the Parties as necessary to effect the intent of this Agreement. In addition, subject to the escalationSteering Committee shall be responsible for, final decision-making authority and dispute resolution procedures in Section 9.9among other things: (a) review, discuss Exchanging information between the Parties (including information generated by their respective Affiliates and approve Sublicensees) with regard to clinical *** Certain information on this page has been omitted and filed separately with the FTE Rate Securities and Exchange Commission. Confidential treatment has been requested with respect to Cothe omitted portions. development (including Clinical Development hereunder), conduct of the C1-Promote activities1310 Study, regulatory submissions and commercialization (including Commercialization hereunder) of Licensed Product and Licensed Compound on a worldwide basis; (b) ensure that each Co-Promotion Plan allocates Monitoring activities related to the Designated Sales Force a pro rata portion manufacturing of centers of excellence and high prescribing physicians for the Opt-In Product(s)Licensed Product; (c) upon request Approving any Cost-overruns related to the C1-2201 Study, as compared to the budgeted costs agreed as of a Party, discuss the appropriate level of detail to include in a Co-Commercialization BudgetEffective Date; (d) reviewApproving the plan(s) for and, discuss if approved, monitoring each Party’s conduct of the ▇▇-▇▇▇▇ ▇▇▇▇▇, Development and approve each proposed Co-Commercialization Plan; while endeavoring Phase IV Trials for Licensed Product, including activities related to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Yearthe Initial Indication, the Transplant Indication and Additional Indications pursuant to Section 3.3; (e) review, discuss Reviewing and approve proposed updates deciding whether to pursue a Proposal (as defined in Section 3.3(a)) jointly or amendments permit a Developing Party to pursue a Co-Commercialization PlanProposal alone or to prevent either Party from pursuing a Proposal if such Proposal is reasonably likely to have a material and adverse effect on the Licensed Product in or outside the Territory (which if such Proposal is pursued thereafter shall be subject to the monitoring of activities (if pursued alone) and approval and monitoring of activities (if pursued jointly) pursuant to Section 2.4(d)); (f) review Coordinating the Parties’ trademark and discuss reports provided pursuant to Section 6.8 or a Co-Promotion AgreementPatent protection for Licensed Product in their respective territories; (g) reviewApproving the plan(s) for and, discuss and provide comments with respect if approved, monitoring Development undertaken pursuant to any promotional materials for Section 3.4(c) (including the Co-Promotion allocation of Opt-In ProductsCosts associated therewith); (h) discuss notification from Kymera that Kymera wishes Reviewing and monitoring the global forecasted demand for Licensed Product and, in connection therewith, approving the Forecasts (as defined in Section 3.1(a) of the Supply Agreement) for Licensed Product pursuant to decrease its then-allocated percentage of Detailingprocedures to be mutually agreed; (i) oversee Coordinating the Parties’ joint promotional efforts;timing of the transfer of responsibility under and ownership of all regulatory filings related to the Licensed Product in the Territory from Pharming to Santarus; and (j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to; (k) review and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Products, including the identity of such agency and the material terms of such engagement; (l) establish the value of secondary position details, consistent with Sanofi’s then-current standard operating procedures; (m) establish benchmarks for the content and effectiveness of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s); (n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (p) determine the anticipated commercial launch date of each Opt-In Product; and (q) perform performing such other functions as are set forth in this Agreement, or as mutually agreed by the Parties may mutually agree in writing, except where in conflict with any provision furtherance of the purposes of this Agreement. Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

Specific Responsibilities. The JCC willJDC shall develop the strategies for and oversee the Development of the Licensed Products in the Licensee Territory and the United States, subject to and shall serve as a forum for the escalationcoordination of Development activities for the Licensed Products for the Licensee Territory and the United States. In particular, final decision-making authority and dispute resolution procedures in Section 9.9the JDC shall: (ai) reviewperiodically ([***]) review the Initial Development Plan, discuss and review and approve the FTE Rate with respect to Co-Promote activitiesamendments thereto, including any Material Amendment; (bii) ensure that each Co-Promotion Plan allocates to the Designated Sales Force serve as a pro rata portion of centers of excellence forum for discussing proposed Joint Development Activities and high prescribing physicians for the Opt-In Product(s)Proposed Unilateral Activities; (ciii) upon request of 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, discuss and review and approve amendments thereto; (vi) periodically review the appropriate level conduct of detail to include in a Co-Commercialization Development activities under each Collaboration Candidate Development Plan and Budget; (dvii) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] oversee the conduct of each relevant Calendar Year; (e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Development activities under the Initial Development Plan; (fviii) review oversee the conduct of Joint Development Activities and discuss reports provided pursuant to Section 6.8 or a Co-Promotion AgreementUnilateral Activities; (gix) review, discuss serve as a forum for discussing and provide comments with respect to any promotional materials coordinating strategies for obtaining Regulatory Approvals for the Co-Promotion of Opt-In ProductsLicensed Products in the Licensee Territory and the United States; (h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailing; (i) oversee the Parties’ joint promotional efforts; (j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to; (k) review and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Products, including the identity of such agency and the material terms of such engagement; (l) establish the value of secondary position details, consistent with Sanofi’s then-current standard operating procedures; (m) establish benchmarks for the content and effectiveness of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s); (n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (px) determine the anticipated commercial launch date of each Opt-In Productwhether a Compound Failure has occurred; and (qxi) establish secure access methods (such as secure databases) for each Party to access the other Party’s Regulatory Documentation and other Information as contemplated under this Agreement; and (xii) perform such other functions as are set forth in this Agreement, herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

Specific Responsibilities. The JCC will, subject shall develop the strategies for and oversee the Commercialization of the Co-Promotion Products in the Co-Promotion Territory and oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the escalationProducts. In particular, final decision-making authority and dispute resolution procedures in Section 9.9the JCC shall: (ai) reviewperiodically (no less often than annually) review and serve as a forum for discussing AbbVie’s Commercialization activities in the AbbVie Territory and AbbVie’s global brand plan for the Products, discuss including marketing and promotional materials, Product messaging, Commercialization budgets and Detailing effort; (ii) establish a strategy for the Commercialization of the Co-Promotion Products in the Co-Promotion Territory; (iii) review and approve the FTE Rate with respect to initial Co-Promote activitiesPromotion Plan; (biv) ensure that each periodically (no less often than annually) review and serve as a forum for discussing the Co-Promotion Plan allocates to the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s)review and approve amendments thereto; (c) upon request of a Party, discuss the appropriate level of detail to include in a Co-Commercialization Budget; (d) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year; (e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Plan; (fv) review and discuss reports provided pursuant approve the manner in which the Markings are to Section 6.8 or a Co-Promotion Agreement; (g) review, discuss and provide comments with respect to any 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 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 Opt-In this Agreement; (vii) oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products; (hviii) discuss notification from Kymera 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 Kymera wishes to decrease AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as such amendment is consistent with AbbVie’s then-allocated percentage current global brand plan for the Products and the other requirements of Detailingthis Agreement; (i) oversee the Parties’ joint promotional efforts; (j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to; (kix) review and discuss approve the engagement by Sanofi form and content of a commercial advertising agency all marketing and promotional materials and all Product messaging to be used in connection the Galapagos Territory with Detailing of respect to the Opt-In Products, including the identity of such agency and the material terms of such engagement; (lx) establish review and approve the value form and content of secondary position details, consistent all training materials to be used in the Galapagos Territory with Sanofi’s then-current standard operating proceduresrespect to the Products; (mxi) establish benchmarks for discuss the content selection of all Distributors and effectiveness of the principal promotional messages that are used by the Parties Third Party co-promoters and promoters engaged to promote the relevant Opt-In Product(s); (n) develop a Corrective Plan support Commercialization activities in the event market research indicates that a Party’s delivery Galapagos Territory and review the performance of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (p) determine the anticipated commercial launch date of each Opt-In Productall such Third Parties; and (qxii) perform such other functions as are set forth in this Agreement, herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

Specific Responsibilities. The JCC willIn addition to its overall responsibility for the collaboration established by this Agreement, subject to the escalation, final decision-making authority and dispute resolution procedures JSC shall in Section 9.9particular: (a) review, discuss review and approve the FTE Rate with respect to initial Core Development Plan for any Co-Promote activitiesProduct; (b) ensure that each review and approve amendments and updates to the Core Development Plan for any Co-Promotion Plan allocates to Promote Product presented by the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s)DWG; (c) upon request of a Party, discuss review amendments and updates to the appropriate level of detail to include in a Development for any Co-Commercialization BudgetPromote Product presented by the DWG; (d) reviewupon receipt of notice from either Party identifying any activity or lack of activity that has or would reasonably be likely to have a material adverse impact on the Development of a Co-Promote Product, review any such activity, and discuss such issue and propose potential actions to mitigate such adverse impact that would be commensurate with the harm or potential harm, and form a Sub Group to further discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each manage potential avenues for the remediation of such Co-Commercialization Plan no later than [***] of each relevant Calendar Yearissue; (e) review, discuss review and approve proposed the Regulatory Strategy (and amendments and updates or amendments to a Co-Commercialization Planthereto) presented by the DWG; (f) review and discuss reports provided pursuant to Section 6.8 or a Co-Promotion Agreementapprove any New Product Proposal; (g) reviewreview and approve the initial Global Strategic Plan and any amendments and updates thereto, discuss and provide comments with respect in each case presented to any promotional materials for the Co-Promotion of Opt-In ProductsJSC by the CWG; (h) discuss notification from Kymera that Kymera wishes review and approve the initial Core Commercialization Plan, including the initial Core Commercialization Budget, and any amendments and updates to decrease its then-allocated percentage of Detailingthe Core Commercialization Plan, including the Core Commercialization Budget, in each case presented to the JSC by the CWG; (i) oversee review the Parties’ joint promotional effortsinitial Non-Core Commercialization Plan, and any amendments and updates to the Non-Core Commercialization Plan presented to the JSC by Kite, and approve the same with respect any Co-Promote Product; (j) specify which commercial functional area experts (other than managed care) of Sanofi review the Designated Sales Force will have access toMedical Affairs Plan and any amendments and updates presented to the JSC by the ERG; (k) review and discuss upon receipt of notice from either Party identifying any activity or lack of activity that has or would reasonably be likely to have a material adverse impact on the engagement by Sanofi Manufacture or Commercialization of a commercial advertising agency Co-Promote Product, discuss such issue and propose actions to mitigate such adverse impact that would be used in connection commensurate with Detailing of the Opt-In Productsharm or potential harm, including and form a Sub Group to further discuss and manage the identity remediation of such agency and the material terms of such engagementissue if appropriate; (l) establish review and approve the value of secondary position details, consistent with Sanofi’s then-current standard operating proceduresGlobal Scientific Publication Strategy (and substantive amendments and updates thereto) presented by the MAC; (m) oversee the DWG, MWG, PSC, CWG; ERG, MAG, and FWG, and establish benchmarks various sub working groups (each, a “Sub Group”) for particular projects or activities, including at the content and effectiveness request of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s); (n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message; (o) establish the PDE Cost; (p) determine the anticipated commercial launch date of each Opt-In ProductDWG, MWG, PSC, CWG, ERG, or FWG; and (qn) perform such other functions as are set forth assigned to it in this Agreement, Agreement or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement. Any failure Agreement as agreed in writing by the Parties, including periodic evaluations of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9performance against goals.