Common use of Responsibilities of the JSC Clause in Contracts

Responsibilities of the JSC. The JSC’s overall responsibility shall be to: (i) review, discuss, and oversee the overall progress of the Parties’ efforts in the performance of the activities under the Research Plan; (ii) review, discuss, and oversee the results and data arising from the research and/or CMC activities under the Research Plan, and provide insight and feedback on potential combinations of Tethers and Effectors; (iii) review, discuss and approve the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Party; (iv) review and provide oversight to the Transition activities and serve as a forum for the coordination of such efforts between the Parties; (v) review, discuss, and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred to the JSC which the JSC has authority to decide or resolve under this Agreement; (ix) review and discuss patent prosecution plans and progresses related to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c); (xi) review and discuss the Pandion Updates provided by Pandion under Section 2.4; and (xii) perform other obligations specifically delegated to it under this Agreement.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Pandion Therapeutics Holdco LLC), License and Collaboration Agreement (Pandion Therapeutics Holdco LLC), License and Collaboration Agreement (Pandion Therapeutics Holdco LLC)

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Responsibilities of the JSC. The JSC’s overall In addition to its general responsibility to oversee and coordinate the conduct of Research under this Agreement and the Development according to the Research Program and the Development Program, ensure a regular flow of Research and Development information between the Parties and to oversee and coordinate the Commercialization of Collaboration Products in the Territory, the JSC shall be toin particular: (a) [***]; (b) [***]; (c) [***]; (d) approve the Annual Research Plan for the period from Effective Date first written above through calendar year 2001 in accordance with Section 5.2.1, and prepare and approve an updated Annual Research Plan during each subsequent year in which the Parties engage in Research activities; (e) review, update and/or approve, as necessary, each applicable and subsequent Annual Research Plan, Annual Research Budget, Annual Development Plan and Annual Development Budget; (f) review and approve any substantive departure from any Annual Research Plan or Annual Research Budget pursuant to Sections 5.2.2 and 5.3.3; (g) approve, as necessary, the Annual Development Plan for the period from the Effective Date through calendar year 2001 in accordance with Section 5.2.1, and prepare and approve an updated Annual Development Plan and Annual Development Budget during each subsequent year in which the Parties engage in Development activities; (h) review and approve any substantive departure from any Annual Development Plan or Annual Development Budget pursuant to Sections 5.2.2 and 5.3.3; (i) review, discuss, and oversee the overall progress activities of the Parties’ efforts in project team(s) that is/are performing the performance of the Party's activities under the Research PlanProgram and the Development Program; (iij) review, discuss, facilitate the flow of information between the Parties with respect to all Research and oversee Development work being conducted for each R&D Candidate in the results Field and data arising from in the research and/or CMC activities under the Research Plan, and provide insight and feedback on potential combinations of Tethers and EffectorsTerritory; (iiik) review[***]; (l) review and approve any recommendations by the Joint Patent Committee that a Third Party License should be entered pursuant to Section 8.8; (m) [***]; (n) review and approve all scientific and clinical protocols, discuss which shall provide that, where appropriate, all preclinical and clinical Development work under this Agreement shall be conducted in accordance with GLPs and GCPs; (o) review and approve the (a) addition contents and filings of one or more new activities into the Research Plan including the Research Budget INDs, applications for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition PlanRegulatory Approval, and the Research Budget associated with such amendment that are proposed by either Partyrelated and supporting submissions to Regulatory Authorities; (ivp) review and provide oversight approve the Commercialization Plan pursuant to the Transition activities and serve as a forum for the coordination of such efforts between the PartiesSection 7.1.4; (v) review, discuss, and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred to the JSC which the JSC has authority to decide or resolve under this Agreement; (ixq) review and discuss patent prosecution plans and progresses related approve a Post BLA Filing Plan pursuant to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c); (xi) review and discuss the Pandion Updates provided by Pandion under Section 2.47.1.4; and (xiir) perform other obligations specifically delegated at least [***] prior to it under this Agreementthe beginning of each calendar year, prepare an estimate of Pro-Forma Net Profits on a Collaboration Product-by-Collaboration Product and country-by-country basis.

Appears in 2 contracts

Samples: Research and Development (Cambridge Antibody Technology Group PLC), Research, Development and Commercialization Agreement (Cambridge Antibody Technology Group PLC)

Responsibilities of the JSC. The JSC’s overall responsibility JSC shall be toperform the following functions: (i) reviewoversee, discuss, guide and oversee approve the overall progress strategic direction of the Parties’ efforts in the performance collaboration with respect to Development of the activities under Combination Therapy (but without modifying or limiting the Research Planrights or obligations of either Party as otherwise set forth herein); (ii) review, discuss, review and oversee approve the results and data arising from the research and/or CMC activities under the Research Development Plan, and provide insight and feedback on potential combinations of Tethers and Effectorsincluding any updates or amendments thereto, in accordance with Section 5.1; (iii) reviewoversee, discuss review and approve coordinate the (a) addition conduct, implementation and progress of one or more new the Development activities into with respect to the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities Combination Therapy under this Agreement, as described in the Research applicable Development Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Party; (iv) review and provide oversight approve the final ICF according to the Transition activities and serve as a forum for the coordination of such efforts between the PartiesSection 5.6; (v) review, discuss, discuss strategy and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compoundregulatory pathway for obtaining Regulatory Approval for the Combination Therapy; (vi) review, discuss, review and approve nominations submitted by either Party of a Compound (the Protocols including any updates or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compoundamendments thereto; (vii) review, discuss, and approve publications proposed consider information provided by either Party under pursuant to Section 11.45.12 with respect to a Third Party subcontractor which that Party wishes to newly involve in the conduct of activities in connection with a Combination Therapy Trial; (viii) decide matters review and resolve disputes referred to coordinate the JSC which supply of the JSC has authority to decide or resolve Products for the Development of the Combination Therapy under this AgreementAgreement in accordance with the Development Plan and Article 8; (ix) review and discuss patent prosecution plans and progresses related approve the contents of the initial publication of the Combination Therapy Clinical Data generated in a Combination Therapy Trial pursuant to Section 10.412.2(a), that either Party reports to each JSC meetingin accordance with the guidelines (including timing and venue) agreed by the JEC; (x) make decisions for any dispute relating exchange information with respect to Joint Collaboration IP Patent Right in accordance each Party’s activities with Section 10.4(c)respect to the Development of such Party’s Product as relevant to the Development of the Combination Therapy pursuant to this Agreement; (xi) review on a quarterly basis the Combination Therapy Clinical Data; (xii) review on a quarterly basis the actual expenditures for the Confirmatory Combination Clinical Trial against the Confirmatory Combination Therapy Trial Budget and discuss any expected overages in accordance with Section 5.4; (xiii) establish, as appropriate, additional sub-committees responsible for managing specific aspects of the Pandion Updates provided Parties’ collaboration as contemplated herein; (xiv) oversee and supervise any subcommittees the JSC may establish as necessary and resolve issues or dispute elevated to it by Pandion under Section 2.4any such subcommittee; and (xiixv) perform such other obligations specifically functions as are assigned to the JSC in this Agreement, or otherwise delegated to it under this Agreementthe JSC by the JEC (within the authority of the JEC) or agreed by the Parties in writing.

Appears in 2 contracts

Samples: Collaboration Agreement (Artiva Biotherapeutics, Inc.), Collaboration Agreement (Artiva Biotherapeutics, Inc.)

Responsibilities of the JSC. The JSC’s overall responsibility JSC shall be toresponsible for overseeing the entire collaboration between GSK and ChemoCentryx during the Collaboration Term under this Agreement, including both the Research Program and 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 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 discover, *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. identify, optimize and develop Collaboration Compounds, Development Candidates and Option Compounds; (b) review, update and approve the PoC Criteria and the Target Product Profiles, all of which shall be subject to final approval by GSK; (c) review, modify, update and approve the PoC Trial designs, as recommended by the JPS, subject to Section 2.3.6; (d) review and approve any potential Indications that should or should not be addressed by each Development Candidate, 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 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; (f) review and update the Research Plan and the Early Development Plans as set forth in Sections 3.5.1 and 3.7.1; (g) serve as an information transfer vehicle to facilitate the discussion of Development and commercialization of Product Candidates and Licensed Products; (h) review and coordinate all of the Parties’ activities under this Agreement during the Collaboration Term; (i) reviewin accordance with the procedures established in Section 2.3.4 and subject to Section 3.6.4, discuss, discuss and oversee the overall progress of the Parties’ efforts in the performance of the activities under the Research Planattempt to resolve any deadlock issues submitted to it by any Subcommittee; (iij) review, discuss, and oversee the results and data arising from the research and/or CMC activities under the Research Plan, and provide insight and feedback on potential combinations of Tethers and Effectors; (iii) review, discuss and approve the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are attempt to resolve any disputes regarding proposed by either Party; (iv) review and provide oversight to the Transition activities and serve as a forum for the coordination of such efforts between the Parties; (v) review, discuss, and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred to the JSC which the JSC has authority to decide or resolve under this Agreement; (ix) review and discuss patent prosecution plans and progresses related to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c); (xi) review and discuss the Pandion Updates provided by Pandion under Section 2.4containing Confidential Information; and (xiik) perform such other obligations specifically delegated responsibilities as may be assigned to it under the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time, provided, however that the JSC shall not have the power to amend or modify this Agreement.

Appears in 2 contracts

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

Responsibilities of the JSC. The JSC’s overall responsibility responsibilities of the JSC shall be exercised consistent with this Agreement and shall include, but shall not be limited to, the following: (a) coordinating the various functional representatives in developing and executing global strategies and plans for the VEGF Products in an effort to ensure global consistency and efficiency, including, but not limited to, establishing global marketing guidelines for determining product pricing, the percentage of sales force incentive compensation linked to VEGF Products and product positioning with regard to VEGF Products (“Global Marketing Guidelines”); (b) approving target profiles for the VEGF Products; (c) reviewing and approving on a timely annual basis the Global Co-Commercialization Plan (including the related Global Co-Commercialization Budget), Co-Development Plans (including related Co-Development Budgets) prepared by the JCC and JDC, as the case may be; (d) reviewing each Country Co-Commercialization Plan (including the related Country Co-Commercialization Budget); (e) reviewing and approving the Manufacturing Plan and changes thereto as submitted by the Supply Chain Sub-Committee; (f) reviewing the efforts of the Parties in performing their respective Co-Development, Commercialization and manufacturing activities; (g) reviewing, and as appropriate requesting, additional information with respect to, the sales performance of the VEGF Products in one or more countries, or throughout the Territory; (h) establishing as sub-committees of the JSC, a Supply Chain Sub-Committee, Intellectual Property Sub-Committee (“IPSC”), Finance Sub-Committee and such additional Joint Sub-Committees from time to time, each of which: (i) shall be composed of representatives of each Party, with co-chairpersons, and otherwise organized in such a manner as the JSC deems appropriate; (ii) shall be delegated such responsibilities as the JSC deems appropriate; and (iii) shall report to the JSC; (i) review, discuss, considering and oversee the overall progress of the Parties’ efforts acting upon such other matters as are specified in the performance of the activities under the Research Plan; (ii) review, discuss, and oversee the results and data arising from the research and/or CMC activities under the Research Plan, and provide insight and feedback on potential combinations of Tethers and Effectors; (iii) review, discuss and approve the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Party; (iv) review and provide oversight to the Transition activities and serve as a forum for the coordination of such efforts between the Parties; (v) review, discuss, and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred to the JSC which the JSC has authority to decide or resolve under this Agreement; (ix) review and discuss patent prosecution plans and progresses related to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c); (xi) review and discuss the Pandion Updates provided by Pandion under Section 2.4; and (xiij) perform other obligations specifically delegated attempting in good faith to resolve any disputes referred to it under this Agreementby any of the other Committee and providing single-point communication for seeking consensus both internally within the respective Party’s organization and together regarding key global strategy and plan issues.

Appears in 2 contracts

Samples: Collaboration Agreement, Collaboration Agreement (Regeneron Pharmaceuticals Inc)

Responsibilities of the JSC. The JSC’s JSC shall perform the following functions: (a) oversee, guide and approve the overall responsibility strategic direction of the Collaboration (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein); (b) discuss and determine which Party will be the Lead Party for the Development of a Collaboration Product under the Expanded Functional Genomics Program and the Additional Pathogen Programs; (c) facilitate communications between the Parties regarding the identification and evaluation of Collaboration Products; 000000000 x00 (x) with respect to Vir Influenza mAbs other than Vir-2482 and Vir 2482XX2, approve each such other Vir Influenza mAb for inclusion in an Influenza Development Plan based on agreed candidate criteria; (e) with respect to the Expanded Functional Genomics Program, approve selection of Expanded Functional Genomics Targets (including in connection with reconsideration of a Rejected Target resubmitted by a Party); (f) with respect to the Additional Pathogen Programs, facilitate the discussion with respect to the selection of each Selected Pathogen and approve such selection; (g) establish, as appropriate, additional sub-committees or working groups responsible for managing specific aspects of the Collaboration as contemplated herein; (h) delegate decision-making authority with respect to specified issues to the applicable subcommittees, provided that any such delegated decision-making shall be to:remain subject to Section 3.9; (i) reviewoversee and supervise the subcommittees and resolve issues or Dispute elevated to it by any subcommittee, discuss, and oversee Program Team or working group the overall progress of the Parties’ efforts in the performance of the activities under the Research PlanJSC may establish; (iij) reviewserve as a forum for each Party to communicate regarding each Party’s interest in participation in further Development of each Collaboration Product, discussincluding approval of proposals from the JRDC for the inclusion of, and oversee the results and data arising from the research and/or CMC activities under the Research Planterms for, and provide insight and feedback on potential combinations of Tethers and EffectorsThird Party assets or Intellectual Property Rights within a given Collaboration Program; (iiik) review, discuss and approve the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Party; (iv) review and provide oversight to the Transition activities and serve as a forum for the coordination of such efforts between the Parties; (v) review, discuss, and approve nominations submitted by Parties to discuss any proposal from either Party for inclusion of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred to programs in the JSC which the JSC has authority to decide or resolve under this Agreement; (ix) review and discuss patent prosecution plans and progresses related to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c2.4.2(b), Section 2.4.2(d) or Section 2.4.3, as applicable; (xil) [***]; (m) for each Collaboration Product, review and approve the initial Development Plan (and the Development Budget therein) in accordance with Section 7.1.2 and any material updates or amendments thereto in accordance with Section 7.1.3; (n) for each Collaboration Product, review and approve the initial Commercialization Plan (including the associated Commercialization Budget) and proposed material updates and amendments thereto [***]; (o) [***]; (p) with respect to any Additional Pathogen Program, determine which Party shall have Manufacturing responsibility for supply of the applicable Additional Pathogen Product for preclinical studies, Phase I Clinical Studies and Phase II Clinical Studies of such Additional Pathogen Product; 224298306 v10 (q) review and discuss the Pandion Updates provided by Pandion under Section 2.4to determine whether any additional Internal Policy of a Party shall be included as a Relevant Internal Policy; and (xiir) perform such other obligations specifically delegated functions as are assigned to it under the JSC in this Agreement, or otherwise agreed by the Parties in writing.

Appears in 1 contract

Samples: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)

Responsibilities of the JSC. The JSC’s overall responsibility JSC shall be toperform the following functions: (i) reviewoversee, discuss, guide and oversee approve the overall progress strategic direction of the Parties’ efforts in the performance collaboration with respect to Development of the activities under Combination Therapy (but without modifying or limiting the Research Planrights or obligations of either Party as otherwise set forth herein); (ii) review, discuss, review and oversee approve the results and data arising from the research and/or CMC activities under the Research Development Plan, and provide insight and feedback on potential combinations of Tethers and Effectors;including any updates or amendments thereto, in accordance with Section 5.1; ​ ​ (iii) reviewoversee, discuss review and approve coordinate the (a) addition conduct, implementation and progress of one or more new the Development activities into with respect to the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities Combination Therapy under this Agreement, as described in the Research applicable Development Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Party; (iv) review and provide oversight approve the final ICF according to the Transition activities and serve as a forum for the coordination of such efforts between the PartiesSection 5.6; (v) review, discuss, discuss strategy and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compoundregulatory pathway for obtaining Regulatory Approval for the Combination Therapy; (vi) review, discuss, review and approve nominations submitted by either Party of a Compound (the Protocols including any updates or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compoundamendments thereto; (vii) review, discuss, and approve publications proposed consider information provided by either Party under pursuant to Section 11.45.12 with respect to a Third Party subcontractor which that Party wishes to newly involve in the conduct of activities in connection with a Combination Therapy Trial; (viii) decide matters review and resolve disputes referred to coordinate the JSC which supply of the JSC has authority to decide or resolve Products for the Development of the Combination Therapy under this AgreementAgreement in accordance with the Development Plan and Article 8; (ix) review and discuss patent prosecution plans and progresses related approve the contents of the initial publication of the Combination Therapy Clinical Data generated in a Combination Therapy Trial pursuant to Section 10.412.2(a), that either Party reports to each JSC meetingin accordance with the guidelines (including timing and venue) agreed by the JEC; (x) make decisions for any dispute relating exchange information with respect to Joint Collaboration IP Patent Right in accordance each Party’s activities with Section 10.4(c)respect to the Development of such Party’s Product as relevant to the Development of the Combination Therapy pursuant to this Agreement; (xi) review on a quarterly basis the Combination Therapy Clinical Data; (xii) review on a quarterly basis the actual expenditures for the Confirmatory Combination Clinical Trial against the Confirmatory Combination Therapy Trial Budget and discuss any expected overages in accordance with Section 5.4; (xiii) establish, as appropriate, additional sub-committees responsible for managing specific aspects of the Pandion Updates provided Parties’ collaboration as contemplated herein; (xiv) oversee and supervise any subcommittees the JSC may establish as necessary and resolve issues or dispute elevated to it by Pandion under Section 2.4any such subcommittee; and (xiixv) perform such other obligations specifically functions as are assigned to the JSC in this Agreement, or otherwise delegated to it under this Agreementthe JSC by the JEC (within the authority of the JEC) or agreed by the Parties in writing.

Appears in 1 contract

Samples: Collaboration Agreement (Affimed N.V.)

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Responsibilities of the JSC. The JSC’s overall responsibility JSC provides strategic direction and operational oversight to the Alliance, evaluates performance, recommends corrective action and shall act as the point of escalation for issues that cannot be toresolved at subcommittee or sub-team levels. Within [[***]] days of the execution of the agreement, the JSC shall jointly establish a charter (the “JSC Charter”) that details specific responsibilities and such JSC Charter will be updated annually to ensure it is focusing on key activities and contractual obligations. Initial considerations for the JSC Charter include: (i) review, discuss, and oversee the overall monitoring performance of this Agreement as well as progress of the Parties’ efforts Collaboration Activities compared to the goals defined in the performance of the activities under the Research PlanCollaboration Plans and deciding on corrective action, where required; (ii) review, discuss, and oversee serving as the results and data arising from principal means by which each Party keeps the research and/or CMC activities under other Party informed about the Research Plan, and provide insight and feedback on potential combinations status of Tethers and Effectorsthose parts of the Collaboration Activities within its responsibilities; (iii) review, discuss reviewing and approve discussing as to whether the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Partydeliverables have been achieved; (iv) review and provide oversight agreeing on changes to the Transition activities and serve as a forum existing Collaboration Plans - including, with respect to the Research Plan in the event of [[***]] - in each case, which do not materially increase or decrease Atara’s or Bayer’s obligations, provided that, for clarity, the coordination of such efforts between JSC shall not have the Partiesauthority to [[***]]; (v) reviewrecommending modifications to the Collaboration Plan which materially increase or decrease Atara’s or Bayer’s obligations, discuss, and approve nominations submitted by either Party of a Compound or any other amendments to be designated (on a Compound-by-Compound basis) as a Transition Compoundthis Agreement; (vi) reviewagreeing on changes to the ATA2271 Plan, discusswhich changes shall be subject to MSK approval prior to taking effect, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) provided that Atara shall use reasonable efforts to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compoundobtain such MSK approval; (vii) reviewidentifying the Bayer Background Technology, discussif any, and approve publications proposed by either Party under Section 11.4to be used in connection with the Collaboration Activities; (viii) decide matters and resolve disputes referred to acting as the JSC which the JSC has authority to decide or resolve under this Agreement;point of escalation for issues that cannot be resolved otherwise; and (ix) review and discuss patent prosecution plans and progresses related performing such other functions as are specifically assigned to Section 10.4, that either Party reports to each the JSC meeting; (x) make decisions for any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c); (xi) review and discuss the Pandion Updates provided by Pandion under Section 2.4; and (xii) perform other obligations specifically delegated to it under this Agreement.

Appears in 1 contract

Samples: Research and Development and License Agreement (Atara Biotherapeutics, Inc.)

Responsibilities of the JSC. The JSC’s overall responsibility JSC shall be toperform the following functions: (i) reviewoversee, discuss, guide and oversee approve the overall progress strategic direction of the Parties’ efforts in the performance of the activities Target Discovery Phase, Early Research Phase and Development under the Research PlanCollaboration, e.g., decide on which therapy areas and diseases the Target Discovery Phase will focus (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein); (ii) review, discuss, consult on and oversee approve the results and data arising from the research and/or CMC activities under the Research Target Discovery Plan, and provide insight and feedback on potential combinations of Tethers and Effectorsany proposed updates thereto recommended by the JRC; (iii) reviewfacilitate communication between the Parties regarding the disposition of Identified Targets and designating each Identified Target (other than those Identified Targets subject to Section 4.3(b)) as one of a Collaboration Target, discuss Unilateral Target, an Identified Target subject to an out-licensing program, or Rejected Target based on each Party’s decision (made in such Party’s sole discretion) as to whether it wishes to participate in and approve fund further Research with respect to the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment (including termination) of pre-approved activities in the Research Plan, the Transition Plan, and the Research Budget associated with such amendment that are proposed by either PartyIdentified Target; (iv) prioritize Collaboration Programs and decide which Party’s discovery infrastructure will be utilized for each Collaboration Program; (v) review and provide oversight approve the JRC’s selection of any Development Candidate for each Collaboration Program and approve the criteria to be used by the Transition JRC in any such selection; (vi) for each Collaboration Program, discuss each Party’s interest in participation in further Research and Development activities following completion of the activities under each Early Collaboration Program Plan; (vii) for each Joint Compound, review and approve the Joint Development Plan (and the Annual Development Budget therein) and any modifications thereto resulting in expenditures over [***]% of the then-existing approved Annual Development Budget; (viii) serve as a forum for 23andMe and GSK to communicate at certain points in time regarding whether one or both Parties will participate in the coordination joint Development of such efforts between the Partieseach Compound or Product; (vix) review, discuss, and approve nominations submitted by either oversee the transfer of the Lead Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis or a Transition Compound-by-Transition Compound basis) as a Licensed Compound; (vii) review, discuss, and approve publications proposed by either Party under Section 11.4; (viii) decide matters and resolve disputes referred role to the JSC which Non-Lead Party when the JSC has authority Non-Lead Party exercises its rights to decide or resolve under become Lead Party pursuant to a mutually agreed transfer plan and the terms of this Agreement; (ix) review and discuss patent prosecution plans and progresses related to Section 10.4, that either Party reports to each JSC meeting; (x) make decisions for perform such other functions as are assigned to the JSC in this Agreement or any dispute relating to Joint Collaboration IP Patent Right in accordance with Section 10.4(c);Ancillary Agreement; and (xi) review oversee and discuss supervise the Pandion Updates provided by Pandion under Section 2.4; and (xii) perform JRC, the JDC, the Data Access Subcommittee, the Finance Subcommittee and any other obligations specifically delegated Subcommittees, and attempt to resolve issues elevated to it under this Agreementby the JRC, the JDC, the Data Access Subcommittee, the Finance Subcommittee or any other Subcommittee.

Appears in 1 contract

Samples: Collaboration Agreement (VG Acquisition Corp.)

Responsibilities of the JSC. 2.5.1 The JSC’s overall responsibility JSC shall be toresponsible for directing the future development of the Alliance, and shall explore new areas of possible cooperation between Institutions and deCODE. 2.5.2 In connection with research sponsored by deCODE at any Institution under a Sponsored Research Agreement or a Clinical Trial Agreement, as applicable, the JSC shall: (ia) reviewReview the research proposals submitted by deCODE or any Institution, discussincluding the Work Plan and budget responding to such research proposal prepared by such Institution, provided that such proposals are consistent with deCODE's internal needs and strategies, and oversee select those research proposals that shall be funded in whole or in part with the overall progress of the Parties’ efforts funds provided under Section 3.2; provided that neither Party shall be required to participate in the performance of the activities under the Research Plana proposed research project without such Party's consent; (iib) reviewUse an accelerated review process, discussas determined by the Parties, to review all such research proposals, including the final work proposal and budget therefor, and, on the basis of such review process, select those research proposals which shall be conducted by an Institution and funded with the funds provided under Section 3.2. (c) Review and approve the terms of each Sponsored Research Agreement, which shall be substantially in the form attached hereto as Appendix A (each, a "Sponsored Research Agreement"), and oversee each Clinical Trial Agreement, which shall be substantially in the results form attached hereto as Appendix B (each, a "Clinical Trial Agreement"), as applicable, which shall be negotiated by the Parties for each research proposal and data arising from budget selected by the research and/or CMC activities under the Research Plan, and provide insight and feedback on potential combinations of Tethers and EffectorsJSC pursuant to Section 2.5.2(a); (iiid) reviewOversee all research projects selected by the JSC pursuant to Section 2.5.2(a), discuss and approve the (a) addition of one or more new activities into the Research Plan including the Research Budget for such activity or (b) material amendment and (including termination) c), using as oversight criteria the research policies of pre-approved activities the Institution in which the research is conducted and the research policies of deCODE, and using periodic informational status reports and updates concerning the sponsored research provided by the Principal Investigator and the deCODE Representative (as such terms are defined in the relevant Sponsored Research PlanAgreements or the Clinical Trial Agreements, as the Transition Plan, and the Research Budget associated with such amendment that are proposed by either Partycase may be); (ive) review and provide oversight to Determine royalty rates, milestone dates, milestone payments and/or annual minimum payments for any License Agreement (as defined in the Transition activities and serve Sponsored Research Agreement or the Clinical Trial Agreement, as a forum for the coordination of such efforts between the Parties; (v) review, discuss, and approve nominations submitted by either Party of a Compound to be designated (on a Compound-by-Compound basis) as a Transition Compound; (vi) review, discuss, and approve nominations submitted by either Party of a Compound (or a Transition Compound, if applicable) to be designated (on a Compound-by-Compound basis entered into between deCODE and an Institution pursuant to any Sponsored Research Agreement or a Transition Compound-by-Transition Compound basis) Clinical Trial Agreement, as a Licensed Compound;the case may be, as provided in such Sponsored Research Agreement or such Clinical Trial Agreement; and (viif) review, discussResolve any disputes between deCODE and any Institution arising under or in connection with any Sponsored Research Agreement or Clinical Trial Agreement. 2.5.3 In connection with the development of the Crosswalk, and approve publications proposed by either Party under Section 11.4;the development, marketing and sales of products and services therefrom, the JSC shall: (viiia) decide matters Review and resolve disputes referred approve the Work Plan and budget for the Crosswalk Project to be conducted pursuant to the JSC Crosswalk Development Agreement, ensuring that such Work Plan includes the cost accounting methods by which costs shall be incurred, a recitation of the JSC has authority allocation of funds for project operating and maintenance costs, the source of funds to decide or resolve under this be used in connection with project costs (including personnel resource contributions from Institutions for operation and maintenance costs), and a work schedule specifying task commencement and completion dates, all as contemplated by the Crosswalk Development Agreement. (b) Oversee the Crosswalk Project, based on periodic reports from the Crosswalk Coordinators appointed by each of the Parties pursuant to the Crosswalk Development Agreement; (ixc) review Establish the commercial terms, including service fees, for use of the Crosswalk, including use of all query tools, other information technology tools and discuss patent prosecution plans infrastructure software, which are components of the Crosswalk and progresses related are used to Section 10.4, that either Party reports to each JSC meetingfacilitate studies with the RPDR or both Databases; (xd) make Review and establish standard operating procedures for the facilitation of studies with the Databases via the Crosswalk. Such standard operating procedures shall prevent disclosure to third parties of Confidential Information of the Parties and patients' confidential information and shall be in compliance with: (i) each Party's internal operating procedures regarding such Party's Database, and (ii) all laws, rules and regulations applicable to such Database, including: (1) in the case of the IHD, the operating license granted to deCODE by the Icelandic Ministry of Health and Social Security, the agreement dated January 21, 2000 between the Icelandic Minister of Health and Social Security and deCODE concerning such operating license and the Icelandic Act on a Health Sector Database No. 139/1998 as same may be amended from time to time, and (2) in the case of the RPDR, the laws, rules and regulations of Massachusetts and the United States government or any agency thereof and the policies of Institutions, including without limitation the decisions for any dispute relating of the Institutional Review Boards of Partners, MGH or BWH. (e) Monitor compliance with all laws with respect to Joint Collaboration IP Patent Right in accordance with Section 10.4(c)the use of the Crosswalk; (xif) review Establish criteria for determining the royalty rate(s) (1) to be paid by deCODE to Institutions based on the revenues obtained from the products and discuss services related to the Pandion Updates provided Crosswalk, and (2) to be paid by Pandion Institutions to deCODE for revenues obtained from Institutions' use of the Crosswalk, or any components of the Crosswalk, pursuant to Section 4.3.1(c), until such time as the Parties discontinue marketing and sales of such products and services, or as determined by the Parties, such products and services have no commercial value; in each case such royalty rate(s) to be based on the customary standards in agreements between academia and industry for joint development of the Crosswalk, including the Crosswalk Intellectual Property Rights to be licensed, which take into account: (i) the type of product or services which shall be developed using such Crosswalk; (ii) the amount of resources (in the form of financial, in kind technology, personnel, and the like) contributed by each Party to the development of the Crosswalk; (iii) the degree to which the license is for a Crosswalk Invention or Crosswalk Copyrightable Work owned solely by Institution, solely by deCODE or jointly by both Parties; (iv) the extent of the development required to create a commercializable product or service; (v) potential sales volume and profitability of the products or services; and (vi) projected expenses to develop and market the products or services. (g) Resolve any disputes between the Crosswalk Coordinators and/or IP Project Leaders of the Parties arising under Section 2.4or in connection with the Crosswalk Development Agreement and this Agreement; and (xiih) perform other obligations specifically delegated to it Resolve any disputes between deCODE and any Institution arising under or in connection with the Crosswalk Development Agreement and this Agreement.

Appears in 1 contract

Samples: Strategic Alliance Agreement (Decode Genetics Inc)

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