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.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Kymera Therapeutics, Inc.), Collaboration and License Agreement (Kymera Therapeutics, Inc.), Collaboration and License Agreement (Kymera Therapeutics, Inc.)

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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.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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.

Appears in 2 contracts

Samples: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)

Specific Responsibilities. The JCC willIn addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall, subject to the escalationterms of this Agreement, final decision-making authority and dispute resolution procedures in Section 9.9particular: (a) review, discuss and approve oversee the FTE Rate with respect to Co-Promote activitiescollaborative activities of the Parties under this Agreement; (b) ensure that oversee the activities of Verve and Beam with respect to each Co-Promotion Development Plan allocates to the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s); (c) upon request of review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Party, discuss the appropriate level of detail to include in a Co-Commercialization BudgetCollaboration Product) and any proposed amendments thereto; (d) review, discuss and approve each proposed Co-Commercialization oversee activities under the Technology Transfer Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year; (e) review, discuss review and decide whether to approve proposed updates or any amendments to a Co-Commercialization Planthe Research Plan submitted by the JRC; (f) review and discuss reports provided pursuant decide whether to Section 6.8 or a Co-Promotion Agreementapprove each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto; (g) review, discuss and provide comments with respect to any promotional materials for Collaboration Products, approve pricing of such Products and supply thereof within the Co-Promotion of Opt-In ProductsCollaboration Territory; (h) discuss notification from Kymera that Kymera wishes to decrease its thenapprove clinical supply plans for Opt-allocated percentage of DetailingIn Products and Collaboration Products and commercial supply plans for Collaboration Products; (i) oversee review and decide whether to approve the Parties’ joint promotional effortsdesignation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs; (j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access toreceive and discuss reports from Subcommittees and provide guidance thereto; (k) review attempt to resolve issues presented to it by, and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Productsdisputes within, including the identity of such agency and the material terms of such engagementany Subcommittee; (l) establish approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the value Collaboration Territory in accordance with the terms and conditions of secondary position details, consistent with Sanofi’s then-current standard operating proceduresSection 13.6.1(a); (m) establish benchmarks approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the content sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and effectiveness conditions of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(sSection 13.6.1(a); (n) develop a Corrective Plan in review and decide whether to approve any other recommendations and submissions from 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 JRC, JMC, JDC and not conveying the corresponding underlying promotional messageJCC; (o) establish such additional Subcommittees as it deems necessary to achieve the PDE Cost;objectives and intent of this Agreement; and (p) determine have any other responsibility expressly designated for the anticipated commercial launch date of each Opt-In Product; and (q) perform such other functions as are set forth in JSC under 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.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Verve Therapeutics, Inc.), Collaboration and License Agreement (Verve Therapeutics, Inc.)

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Specific Responsibilities. The JCC will, subject In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the escalationParties’ activities under this Agreement, final decision-making authority and dispute resolution procedures the JSC will in Section 9.9particular: (a) review, discuss discuss, and determine whether to approve the FTE Rate with respect to Co-Promote activitiesupdated Transition Plan; (b) ensure that each review, discuss, and determine whether to approve the Development Plan, the planned PMF network, and the Commercialization Plan, and all amendments thereto (but, for clarity, not including the terms of 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(spromotion Agreement); (c) upon request of a Partyreview and discuss any material revisions to the Development Milestone Achievement Dates proposed by GEHC in accordance with Section 4.2.2 (Amendments to the Development Plan), discuss and measure performance against the appropriate level of detail to include in a Cothen-Commercialization Budgetcurrent Development Milestone Achievement Dates; (d) review, discuss and approve provide input regarding when to initiate or discontinue any Clinical Trial under each proposed Co-Commercialization Development Plan; while endeavoring provided that nothing is intended to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Yearlimit a Party’s ability to comply with Applicable Law or manage subject safety; (e) reviewdiscuss the requirements for Regulatory Approval and, discuss where applicable, Pricing Approval, in the Core Markets and approve proposed updates or amendments review and determine overall regulatory strategy with respect to a Co-Commercialization Planthe Licensed Product in the Field; (f) review and discuss reports provided pursuant to Section 6.8 or a Cothe Development, Manufacture, and Commercialization of the Licensed Product in the Field, including measuring performance against, and compliance with, the then-Promotion Agreementcurrent Development Plan and Commercialization Plan; (g) review, discuss and provide comments facilitate the flow of information between the Parties with respect to any promotional materials for the Co-Promotion Development and Commercialization of Opt-In Productsthe Licensed Product in the Field; (h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailingdiscuss, on *** basis, any *** (as applicable) during the previous ***; (i) oversee the Parties’ joint promotional effortsattempt to resolve issues presented to it by either Party relating to this Agreement, and disputes within any other subcommittee; (j) specify which commercial functional area experts (other than managed care) establish additional Committees and restructure existing Committees as it deems necessary to achieve the objectives and intent 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 Productthis Agreement; and (qk) perform such other functions as are set forth in appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement, or in each case, as agreed in writing by 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 9.9Parties.

Appears in 1 contract

Samples: Collaboration and License Agreement (Lantheus Holdings, Inc.)

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