Common use of Responsibilities of the JSC Clause in Contracts

Responsibilities of the JSC. The JSC shall have the responsibility and authority to: a) monitor and implement the transfer of the SRA Product to Roche; b) oversee, monitor and approve the Research Plan; c) revise and approve any revisions to the Research Plan; d) review and oversee the execution of the Research Plan; e) establish timelines and criteria for decision points; f) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); g) identify appropriate resources necessary to conduct the Research Plan; h) decide whether to pursue options (1), (2) or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) prior to the designation of an SRA Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Development Candidate, and review and update the SRA Development Deadline Document and the “Development Deadline Document” under the SRA as it may deem advisable, in each case as further provided in Article 3 of the SRA; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**], and [**] and [**] diseases, indications or medical conditions [**]; s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s respective decision-making bodies for approval or rejection by such decision-making bodies; w) attempt to resolve any disputes on an informal basis; and x) otherwise serve as a forum for exchanging information and discussing the progress of the collaboration between PTC, Roche and the Foundation under this Agreement, including, without limitation, Product commercialization activities. The JSC shall have no responsibility and authority other than that expressly set forth in this Section.

Appears in 2 contracts

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

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Responsibilities of the JSC. The Except as may be otherwise expressly set forth herein, Amarin will have final planning, oversight, performance evaluation and decision-making authority and responsibility for all sales, marketing and Promotional activities and attendant compliance activities related to the Product and Product Labeling. Notwithstanding the foregoing, Kowa will have the opportunity, through the JSC to confer with, or recommend ideas or Promotional Materials to, Amarin regarding such sales, marketing and Promotional matters. Without limiting the rights, obligations and responsibilities expressly reserved by Amarin under Section 2.1 (and Amarin’s decision-making authority with respect thereto), matters to come before the JSC shall have be limited to the responsibility and authority tofollowing: (a) monitor Reviewing available Gross Sales, Net Sales, and implement other Territory-specific Product performance data as determined by the transfer JSC; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. (b) Making recommendation for new materials for commercial support and Promotional Materials such as product detail aids, advertising, educational give-aways, speaker meetings, speaker kits and direct mail; (c) Reviewing Sample demand forecast; (d) Coordinating joint activities undertaken by the Parties in accordance with Section 4.11; (e) Reviewing and discussing any market research conducted by either Party with respect to the Product in the Field in the Territory; (f) Reviewing monthly activities of Sales Representatives; (g) Reviewing the efforts of Sales Representatives who engage in Detailing and other Promotional efforts with respect to the Product to maintain desired frequency of Details and to avoid unintended duplication of Details; (h) Reviewing, commenting on, and approving the annual Promotion Plan for the Product in accordance with Section 4.2 and monitoring the implementation of the SRA Product to Roche; b) oversee, monitor and approve the Research Promotion Plan; c(i) revise Reviewing and approve any revisions auditing training needs and schedule, including corrective training; (j) Discussing whether a Major Market Event has occurred and making recommendations with respect thereto; (k) Establishing subcommittees on an as-needed and as-appropriate basis (e.g., a compliance subcommittee and/or a medical activities subcommittee to oversee medical / scientific matters), overseeing the activities of all subcommittees so established, and addressing disputes or disagreements arising in all such subcommittees; (l) Considering and making recommendations on such other matters as are stipulated in this Agreement (e.g., non-commercial matters); and (m) Performing such other responsibilities as may be assigned to the Research Plan; d) review and oversee the execution of the Research Plan; e) establish timelines and criteria for decision points; f) review the efforts of JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties and allocate those resources for the Research Plan (including the budget); g) identify appropriate resources necessary in writing from time to conduct the Research Plan; h) decide whether to pursue options (1), (2) or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at each JSC meeting prior to time; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) prior to the designation of an SRA Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Development Candidate, and review and update the SRA Development Deadline Document and the “Development Deadline Document” under the SRA as it may deem advisable, in each case as further provided in Article 3 of the SRA; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. provided, and [**] and [**] diseaseshowever, indications or medical conditions [**]; s) at that the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s respective decision-making bodies for approval or rejection by such decision-making bodies; w) attempt to resolve any disputes on an informal basis; and x) otherwise serve as a forum for exchanging information and discussing the progress of the collaboration between PTC, Roche and the Foundation under this Agreement, including, without limitation, Product commercialization activities. The JSC shall have no responsibility and authority other than that expressly set forth in to amend any provision of this SectionAgreement, make any binding interpretation of this Agreement, or determine whether or not a breach of this Agreement has occurred or to otherwise increase the devotion of financial or human resources of Kowa under this Agreement.

Appears in 1 contract

Samples: Co Promotion Agreement (Amarin Corp Plc\uk)

Responsibilities of the JSC. The JSC shall have be responsible for overseeing the responsibility entire collaboration between GSK and authority to: a) monitor ChemoCentryx during the Collaboration Term under this Agreement, including both the Research Program and implement each Early Development Program. With respect to the Product Candidate Commercialization Program, the JSC shall serve only as a vehicle to facilitate the transfer of information between the SRA Parties, and the JSC will not have any decision making authority over any aspect of the Product Candidate Commercialization Program or over any other Development or commercialization matters after the exercise by GSK of its Product Option. Without limiting the foregoing, the JSC shall perform the following functions, some or all of which may be addressed directly at any given meeting of the JSC: (a) review the overall progress of ChemoCentryx’s efforts to Rochediscover, identify, optimize and develop Collaboration Compounds, Development Candidates and Option Compounds; (b) overseereview, monitor update and approve the Research PlanPoC Criteria and the Target Product Profiles, all of which shall be subject to final approval by GSK; (c) revise review, modify, update and approve any revisions the PoC Trial designs, as recommended by the JPS, subject to the Research PlanSection 2.3.6; (d) review and oversee the execution of the Research Plan; e) establish timelines and criteria for decision points; f) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); g) identify appropriate resources necessary to conduct the Research Plan; h) decide whether to pursue options (1), (2) approve any potential Indications that should or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at should not be addressed by each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) prior to the designation of an SRA Development Candidate, prepare Progressed Compound(s) or other Collaboration Compound against each Collaboration Target, as provided in Section 2.3.5; (e) review and approve and update the SRA Development Plan Target Product Profile established by GSK for Collaboration Compounds directed against each Collaboration Target, subject to final approval and final decision-making authority by GSK; *** Certain information on this page has been omitted and filed separately with the “Development Plan” under Commission. Confidential treatment has been requested with respect to the SRA for such SRA Development Candidate, and omitted portions. (f) review and update the SRA Development Deadline Document Research Plan and the Early Development Deadline Document” under Plans as set forth in Sections 3.5.1 and 3.7.1; (g) serve as an information transfer vehicle to facilitate the SRA as it may deem advisable, in each case as further provided in Article 3 discussion of Development and commercialization of Product Candidates and Licensed Products; (h) review and coordinate all of the SRAParties’ activities under this Agreement during the Collaboration Term; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**], and [**] and [**] diseases, indications or medical conditions [**]; s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during in accordance with the SRA Research Term procedures established in Section 2.3.4 and either designating subject to Section 3.6.4, discuss and attempt to resolve any deadlock issues submitted to it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRAany Subcommittee; t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s respective decision-making bodies for approval or rejection by such decision-making bodies; w(j) attempt to resolve any disputes on an informal basisregarding proposed publications containing Confidential Information; and x(k) otherwise serve such other responsibilities as a forum for exchanging information and discussing may be assigned to the progress of JSC pursuant to this Agreement or as may be mutually agreed upon by the collaboration between PTCParties from time to time, Roche and provided, however that the Foundation under JSC shall not have the power to amend or modify this Agreement, including, without limitation, Product commercialization activities. The JSC shall have no responsibility and authority other than that expressly set forth in this Section.

Appears in 1 contract

Samples: Product Development and Commercialization Agreement (ChemoCentryx, Inc.)

Responsibilities of the JSC. The Except as may be otherwise expressly set forth herein, Amarin will have final planning, oversight, performance evaluation and decision-making authority and responsibility for all sales, marketing and Promotional activities and attendant compliance activities related to the Product and Product Labeling. Notwithstanding the foregoing, Kowa will have the opportunity, through the JSC to confer with, or recommend ideas or Promotional Materials to, Amarin regarding such sales, marketing and Promotional matters. Without limiting the rights, obligations and responsibilities expressly reserved by Amarin under Section 2.1 (and Amarin’s decision-making authority with respect thereto), matters to come before the JSC shall have be limited to the responsibility and authority tofollowing: (a) monitor Reviewing available Gross Sales, Net Sales, and implement other Territory-specific Product performance data as determined by the transfer JSC; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. (b) Making recommendation for new materials for commercial support and Promotional Materials such as product detail aids, advertising, educational give-aways, speaker meetings, speaker kits and direct mail; (c) Reviewing Sample demand forecast; (d) Coordinating joint activities undertaken by the Parties in accordance with Section 4.11; (e) Reviewing and discussing any market research conducted by either Party with respect to the Product in the Field in the Territory; (f) Reviewing monthly activities of Sales Representatives; (g) Reviewing the efforts of Sales Representatives who engage in Detailing and other Promotional efforts with respect to the Product to maintain desired frequency of Details and to avoid unintended duplication of Details; (h) Reviewing, commenting on, and approving the annual Promotion Plan for the Product in accordance with Section 4.2 and monitoring the implementation of the SRA Product to Roche; b) oversee, monitor and approve the Research Promotion Plan; c) revise and approve any revisions to the Research Plan; d) review and oversee the execution of the Research Plan; e) establish timelines and criteria for decision points; f) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); g) identify appropriate resources necessary to conduct the Research Plan; h) decide whether to pursue options (1), (2) or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) prior to the designation of an SRA Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Development Candidate, and review and update the SRA Development Deadline Document and the “Development Deadline Document” under the SRA as it may deem advisable, in each case as further provided in Article 3 of the SRA; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**], and [**] and [**] diseases, indications or medical conditions [**]; s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as Reviewing and auditing training needs and schedule, including corrective training; (j) Discussing whether a Major Market Event has occurred and making recommendations with respect thereto; (k) Establishing subcommittees on an SRA Development Candidate during as-needed and as-appropriate basis (e.g., a compliance subcommittee and/or a medical activities subcommittee to oversee medical / scientific matters), overseeing the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteriaactivities of all subcommittees so established, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders addressing disputes or disagreements arising in all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRAsuch subcommittees; t(l) oversee the progress of the Product Development ProgramConsidering and making recommendations on such other matters as are stipulated in this Agreement (e.g., including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s respective decisionnon-making bodies for approval or rejection by such decision-making bodies; w) attempt to resolve any disputes on an informal basiscommercial matters); and x(m) otherwise serve Performing such other responsibilities as a forum for exchanging information and discussing may be assigned to the progress of JSC pursuant to this Agreement or as may be mutually agreed upon by the collaboration between PTCParties in writing from time to time; provided, Roche and however, that the Foundation under this Agreement, including, without limitation, Product commercialization activities. The JSC shall have no responsibility and authority other than that expressly set forth in to amend any provision of this SectionAgreement, make any binding interpretation of this Agreement, or determine whether or not a breach of this Agreement has occurred or to otherwise increase the devotion of financial or human resources of Kowa under this Agreement.

Appears in 1 contract

Samples: Co Promotion Agreement

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Responsibilities of the JSC. The JSC shall have be the responsibility primary vehicle for interaction between the Parties with respect to the Research Program and authority tothe Development of Schering Viral Products, and shall function as a forum for the Parties to inform and consult with one another concerning progress of the Research Program and make decisions regarding the Research Program, as well as for Schering to inform and consult with PTC concerning the Development of Schering Viral Products. Without limiting the foregoing, the JSC shall be responsible for: a(i) monitor directing, managing and implement monitoring the transfer progress of the SRA Product to RocheResearch Program; b(ii) oversee, monitor and approve making any modifications to the Research PlanPlan as the JSC deems appropriate; c(iii) revise developing and approve any revisions approving a charter for a joint project team, which shall include participation of appropriate representatives from both Parties and shall be responsible for drafting recommendations with respect to the Research Plan; d(iv) review identifying to the Parties that the criteria set forth in Schedule 1.14 as guidelines for Development Candidates have been reasonably met with respect to a particular Collaboration Compound, and oversee the execution of the Research Planmaking recommendations to Schering that one or more Collaboration Compounds be designated by Schering as a Development Candidate; e(v) establish timelines reviewing and approving any changes to Schedule 1.14, and developing and approving criteria for decision pointsthe Back-Up Development Candidate referenced in Section 1.3; f(vi) review the efforts of the Parties making recommendations to Schering that one or more Collaboration Compounds be designated by Schering as a Back-Up Development Candidate; (vii) reviewing and allocate those resources approving Schering's initial Development Plans for the Research Plan first Development Candidate or first Back-Up Development Candidate, as well as reviewing and commenting upon (including but not approving) any changes to such Development Plans which Schering determines are necessary or appropriate (for clarity, if the budget); g) identify appropriate resources necessary to conduct the Research Plan; h) decide whether to pursue options (1), (2) Development of a Development Candidate or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Back-Up Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) Candidate is terminated for any reason prior to the designation first Regulatory Approval of an SRA such Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Candidate or Back-Up Development Candidate, and review Schering subsequently continues to Develop one or more other Schering Viral Products, then the next most advanced Development Candidate (and, if any exist, the next most advanced Back-Up Development Candidate) shall be deemed "first" for the purposes of this Section 3.3(vii)); (viii) reviewing the progress under such Development Plans; EXECUTION VERSION (ix) reviewing and update commenting upon the SRA Development Deadline Document patent filing and prosecution strategies of the “Development Deadline Document” under the SRA Parties as it may deem advisable, in each case as further provided in Article 3 9, including directing, managing and monitoring the activities of the SRA; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements Patent Team pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**], and [**] and [**] diseases, indications or medical conditions [**]; s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s respective decision-making bodies for approval or rejection by such decision-making bodies; w) attempt to resolve any disputes on an informal basis9.3(e); and (x) otherwise serve as a forum for exchanging information reviewing and discussing coordinating each Party's internal approval of any publications by the progress of Parties to the collaboration between PTC, Roche and the Foundation under this Agreement, including, without limitation, Product commercialization activities. The JSC shall have no responsibility and authority other than that expressly set forth in this Sectionextent required pursuant to Section 7.7.

Appears in 1 contract

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

Responsibilities of the JSC. The In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC shall in particular have the responsibility and authority to: (a) create and disband the JRDT and other JOTs when deemed appropriate (provided, however that the timing for creating the JRDT and other JOTs must be agreed upon by both Parties and are not subject to final decision by either Party); (b) establish and set expectations and activities for the JRDT and other JOTs (provided, however that the allocation of responsibilities among the teams must be agreed upon by both Parties and are not subject to final decision by either Party); (c) oversee the JRDT and other JOTs; (d) discuss and approve Collaboration Plans as established and presented by the JRDT for additional Collaboration Products, Roche Products, SQZ Products and TCL Products, including timelines, date of Initiation and criteria for decision points and Clinical PoC criteria, provided, however, that with respect to Roche Products, Roche has final decision making authority at the JSC, which is not subject to final decision by SQZ; (e) revise and approve any revisions to a Collaboration Plan as established and presented by the JRDT, including budget, for the current and the subsequent two (2) Calendar Years (or three (3) Calendar Years for Licensed Products) if Development Costs will be shared during that period (provided, however that Clinical PoC criteria for Collaboration Products, and TCL Products must be agreed upon by both Parties and are not subject to final decision by SQZ); (f) review and oversee the execution of Collaboration Plans; (g) review and oversee exploratory research related to TCL and potential Antigens suggested by Roche; (h) discuss and approve plans for additional research outside Collaboration Plans, including improvements to antigen-presenting cells; (i) approve criteria for BBS in the same form or similar form to Initial Antigen Product BBS criteria set forth in Appendix 1.9 for a given Antigen Product or TCL Product at least six (6) months prior to the anticipated BBS for such Antigen Product or TCL Product (approval of criteria for a TCL Product requires mutual consent of both Parties and is not subject to final decision by SQZ), as applicable and determine whether criteria have been met; (j) approve criteria for entry into human for a given Antigen Product or TCL Product at least six (6) months prior to the anticipated Initiation of a first Phase I Study; (k) monitor the development of Licensed Products in the Field; (l) monitor implementation of the transfer to Roche of the SQZ Platform and Microfluidic Chips to Roche for use with Licensed Products through the JRDT; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. (m) monitor and implement the transfer of the SRA Product Licensed Products to Roche, in accordance with the terms of this Agreement; b) oversee, monitor and approve the Research Plan; c) revise and approve any revisions to the Research Plan; d) review and oversee the execution of the Research Plan; e) establish timelines and criteria for decision points; f) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); g) identify appropriate resources necessary to conduct the Research Plan; h) decide whether to pursue options (1), (2) or (3) of Section 2(g) of the Second SRA Amendment in the event of an SRA Cost/Timeline Issue; i) maintain and update, at each JSC meeting prior to [**], a list that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; j) prior to the designation of an SRA Development Candidate, prepare the SRA Development Plan and the “Development Plan” under the SRA for such SRA Development Candidate, and review and update the SRA Development Deadline Document and the “Development Deadline Document” under the SRA as it may deem advisable, in each case as further provided in Article 3 of the SRA; k) establish and set expectations and mandates for each joint operational team (each, a “JOT”); l) create or disband JOTs as deemed appropriate; m) oversee the JOTs, including without limitation the joint intellectual property team (“Joint IP Team” or “JIPT”); n) approve variations of Invention assignment agreements pursuant to Section 15.1; o) revise and approve any revisions to the Development Candidate Criteria; p) determine whether an SRA Drug Candidate has become an SRA Development Candidate or whether New Compound has become a New Compound Development Candidate; q) following the designation of an SRA Development Candidate, and at least [**] thereafter, conduct a formal review and comprehensive update of the SRA Development Plan and SRA Development Deadline Document for such SRA Development Candidate, in each case as further provided in Article 3 of the SRA; r) review scientific and medical literature to identify diseases, indications or medical conditions that, [**] are [**] for [**], and [**] and [**] diseases, indications or medical conditions [**]; s) at the first JSC meeting after [**], (i) review each potential or actual SRA Lead Candidate that was not designated as an SRA Development Candidate during the SRA Research Term and either designating it as an SRA Development Candidate or determining that it does not meet the Development Candidate Criteria, and (ii) prepare a final list (which can only be subsequently changed by the written agreement of Roche, PTC and Foundation) that identifies and rank orders all potential and actual SRA Lead Candidates and SRA Development Candidates and denotes all SRA Development Candidates and between [**] potential or actual SRA Lead Candidates as SRA Reversion Candidates and as “Reversion Candidates” under the SRA; t) oversee the progress of the Product Development Program, including without limitation, with respect to SRA Development, pursuant to Article 3 of the SRA; u) monitor the development of the New Compounds and the New Products in the Field; v) recommend action items to each Party’s or the Foundation’s its respective decision-making bodies for approval or rejection by such decision-decision making bodies; w(o) attempt to resolve any disputes on an informal basis; and x(p) otherwise serve perform such other functions as a forum for exchanging information appropriate, and discussing direct each JOT to perform such other functions as appropriate, to further the progress purposes of the collaboration between PTC, Roche and the Foundation under this Agreement, including, without limitation, Product commercialization activitiesin each case as agreed in writing by the Parties (with neither Party having a casting vote thereon). The JSC shall have no responsibility and authority other than that expressly set forth in this SectionSection 9.2.2.

Appears in 1 contract

Samples: License and Collaboration Agreement (SQZ Biotechnologies Co)

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