Common use of Responsibilities and Authority Clause in Contracts

Responsibilities and Authority. The JSC’s overall responsibility shall be to encourage and facilitate ongoing cooperation and communication between the Parties regarding the Development Program and any other activities contemplated by this Agreement. Subject to the terms and conditions of this Agreement, the JSC shall have the authority to: (a) Make decisions with respect to the following matters, which are deemed Unanimous Matters (as defined below) for purposes of this Agreement: (i) review, discuss and approve any substantive changes or updates to the Development Plan, including the budget and timelines included in the Development Plan; (ii) review, discuss and approve the Company’s protocol, scope and design for any Clinical Trial of a Compound or Product contemplated by the Development Plan, and any material changes thereto; (iii) review and approve (i) the engagement of Third Party subcontractors that are first engaged after the Effective Date to perform work related to the Development Program, or (ii) any new or additional work related to the Development Program, or in preparation for post-Development Program activities, to be performed by any Third Party subcontractor, in each case of clause (i) and (ii), in excess of $[***] in any calendar year or $[***] in the aggregate (for clarity, to the extent such amounts are related to the Development Program), including in each case of clause (i) and (ii), (A) any Third Party subcontractors responsible for process development, (B) any Third Party contract manufacturer of any Compound or Product (whether drug substance or drug product), including in preparation for Phase 3 Clinical Trials, or (C) any Third Party contract research organization that would manage any Clinical Trial of any Compound or Product; (iv) to review and approve the acquisition or in-license by the Company of any Intellectual Property Controlled by a Third Party that is or would be reasonably likely to be necessary or reasonably useful for the exploitation of any Compound or Product; and (v) periodically assess whether the Development Program is commercially reasonable, or scientifically or operationally viable, and determine whether the Development Program should be continued. (b) Consider the following matters: (i) review and discuss Development Program activities, and the results of such activities; (ii) discuss progress reports and other information generated by the Company in performing the Development Program and request other information relating to the progress of the goals or performance of the Development Program; (iii) review and discuss regulatory correspondences and ongoing regulatory strategy relating to any Compound or Product; (iv) review and discuss CMC matters (including process development) relating to any Compound and Product; (v) review and advise on filing, prosecution and maintenance strategy for Patents within the Program Technology, including any Patents arising in the Development Program; provided, that such filing, prosecution and maintenance shall be subject to the terms and conditions of the BMS License Agreement, as applicable; (vi) discuss and address scientific or technical issues arising in the course of the Development Program; (vii) review on a monthly basis (which frequency can be changed by mutual agreement of the Parties) the status of the budget for the conduct of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget in the Development Plan, and the Company’s financial position; (viii) encourage and facilitate cooperation and communication between the Parties with respect to the Development Program; (ix) establish subcommittees, which will report to the JSC, as needed to further the purposes of this Agreement; and (x) perform such other functions as are expressly delegated to it under this Agreement or as the Parties agree in writing.

Appears in 1 contract

Samples: Collaboration and Option Agreement (Homology Medicines, Inc.)

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Responsibilities and Authority. The JSC’s overall responsibility shall be to encourage JSC will oversee the conduct of the Research Activities and facilitate ongoing cooperation the IIT and communication between will serve as the Parties main forum for sharing of progress, technical challenges and Results and decision-making regarding the Development Program and any other activities contemplated by this Agreementsame. Subject to Without limiting the terms and conditions of this Agreementforegoing, the JSC shall have the authority toshall: (a) Make decisions discuss and approve the R&D Plan and any amendments or updates thereto; (b) discuss and approve the product characterization, release criteria and specifications for [*], in each case, for the lots of the SN301A Product to be used in the IIT, and any revisions or updates thereto; (c) discuss and approve the protocol for the IIT (“Protocol”) and any amendments thereto (other than an amendment requested by the IRB, which shall be handled in accordance with Section 4.2); (d) if applicable, discuss and approve a replacement principal investigator [*] or a replacement trial site; (e) review and discuss, prior to execution by Xxxxxx, all clinical trial agreement(s) with the trial site(s) for the IIT [*]; (f) facilitate the exchange of information between the Parties concerning adverse events or any other safety issue of any significance with respect to the following matters, which are deemed Unanimous Matters (as defined below) for purposes of this Agreement: (i) review, discuss and approve any substantive changes or updates to the Development Plan, including the budget and timelines included in the Development PlanSN301A Product; (ii) review, discuss and approve the Company’s protocol, scope and design for any Clinical Trial of a Compound or Product contemplated by the Development Plan, and any material changes thereto; (iiig) review and approve (i) all material regulatory submissions to and correspondences with Regulatory Authorities regarding the engagement of Third Party subcontractors that are first engaged after Research Activities or the Effective Date to perform work related IIT, including but not limited to the Development Program, or (ii) any new or additional work related initial submission to the Development Program, or in preparation for post-Development Program activities, IRB (and subsequent amendments thereto prior to obtaining the IRB approval therefor) and any informed consent forms to be performed by any Third Party subcontractor, in each case of clause (i) and (ii), in excess of $[***] in any calendar year or $[***] used in the aggregate (for clarity, to the extent such amounts are related to the Development Program), including in each case of clause (i) and (ii), (A) any Third Party subcontractors responsible for process development, (B) any Third Party contract manufacturer of any Compound or Product (whether drug substance or drug product), including in preparation for Phase 3 Clinical Trials, or (C) any Third Party contract research organization that would manage any Clinical Trial of any Compound or ProductIIT; (ivh) to review oversee the performance of the IIT and approve the acquisition or in-license by the Company of any Intellectual Property Controlled by a Third Party that is or would be reasonably likely to be necessary or reasonably useful for the exploitation of any Compound or Product; and (v) periodically assess whether the Development Program is commercially reasonable, or scientifically or operationally viable, and determine whether the Development Program should be continued. (b) Consider the following matters:R&D Plan; (i) review all Inventions and discuss Development Program activities, and the results of such activitiesmaterial Results; (iij) discuss progress reports after the initiation and other information generated by initial enrollment of patients in the Company in performing IIT, make go/no-go decisions regarding the Development Program and request other information relating to the progress of the goals or continued performance of the Development ProgramIIT, provided that [*]; (iiik) review and discuss regulatory correspondences and ongoing regulatory strategy relating approve, prior to its occurrence, any Compound publication or Product;public disclosure of Results, provided that the JSC shall make its decision (i.e., whether to approve or not approve) within two (2) weeks; and (ivl) review and discuss CMC matters (including process development) relating to any Compound and Product; (v) review and advise on filingperform such other functions as appropriate, prosecution and maintenance strategy for Patents within the Program Technology, including any Patents arising in the Development Program; provided, that such filing, prosecution and maintenance shall be subject to the terms and conditions of the BMS License Agreement, as applicable; (vi) discuss and address scientific or technical issues arising in the course of the Development Program; (vii) review on a monthly basis (which frequency can be changed by mutual agreement of the Parties) the status of the budget for the conduct of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget in the Development Plan, and the Company’s financial position; (viii) encourage and facilitate cooperation and communication between the Parties with respect to the Development Program; (ix) establish subcommittees, which will report to the JSC, as needed to further the purposes of this Agreement; and (x) perform such other functions , in each case as are expressly delegated to it under this Agreement or as agreed in writing by the Parties agree in writingParties.

Appears in 1 contract

Samples: Collaboration and Option Agreement (Senti Biosciences, Inc.)

Responsibilities and Authority. The JSC’s overall responsibility shall be to oversee the Research Program and to encourage and facilitate collaboration and communication between the Parties regarding the Research Program. The specific responsibilities of the JSC shall be: (i) to periodically review the Research Plan and Research Budget and, subject to Sections 3.1(e) and 3.1(f), approve updates or amendments thereto from time to time; (ii) to review and, subject to Sections 3.1(e) and 3.1(f), approve the protocols for the Research Plan IND-Enabling Studies and the Research Plan Trials; (iii) to provide a forum for review and discussion of the results of Research Plan Activities; (iv) to encourage and facilitate ongoing cooperation and communication between the Parties regarding the Development Program and any other activities contemplated by this Agreement. Subject to the terms and conditions of this Agreement, the JSC shall have the authority to: (a) Make decisions with respect to the Research Program and in planning, and, following matters, which are deemed Unanimous Matters (as defined below) for purposes Xxxxxxx’x delivery of this Agreement: (i) review, discuss and approve any substantive changes or updates an Election to the Development Plan, including the budget and timelines included Proceed Notice in the Development Plan; (ii) review, discuss and approve the Company’s protocol, scope and design for any Clinical Trial of a Compound or Product contemplated by the Development Plan, and any material changes thereto; (iii) review and approve (i) the engagement of Third Party subcontractors that are first engaged after the Effective Date to perform work related to the Development Program, or (ii) any new or additional work related to the Development Program, or in preparation for post-Development Program activities, to be performed by any Third Party subcontractor, in each case of clause (i) and (iiaccordance with Section 4.8(b), in excess executing, the transfer of $[***] in any calendar year or $[***] in the aggregate (responsibility for clarity, further Development and Manufacture of Compounds and Products to the extent such amounts are related to the Development Program), including in each case of clause (i) and (ii), (A) any Third Party subcontractors responsible for process development, (B) any Third Party contract manufacturer of any Compound or Product (whether drug substance or drug product), including in preparation for Phase 3 Clinical Trials, or (C) any Third Party contract research organization that would manage any Clinical Trial of any Compound or Product; (iv) to review and approve the acquisition or in-license by the Company of any Intellectual Property Controlled by a Third Party that is or would be reasonably likely to be necessary or reasonably useful for the exploitation of any Compound or Product; and (v) periodically assess whether the Development Program is commercially reasonable, or scientifically or operationally viable, and determine whether the Development Program should be continued. (b) Consider the following matters: (i) review and discuss Development Program activities, and the results of such activities; (ii) discuss progress reports and other information generated by the Company in performing the Development Program and request other information relating to the progress Xxxxxxx upon completion of the goals or performance of the Development Research Program; (iii) review and discuss regulatory correspondences and ongoing regulatory strategy relating to any Compound or Product; (iv) review and discuss CMC matters (including process development) relating to any Compound and Product; (v) review and advise on filing, prosecution and maintenance strategy for Patents within to serve as the Program Technology, including any Patents arising principal means (in the Development Program; provided, that such filing, prosecution and maintenance shall be subject addition to the terms reports each Party is obligated to deliver to the other Party pursuant to Section 4.7) by which (A) each Party keeps the other Party reasonably informed regarding the progress and conditions results of Research Plan Activities, (B) Xxxxxxx keeps Cidara reasonably informed regarding the BMS License Agreementprogress and results of any Development (including CMC Development) and Manufacturing activities with respect to any Compound or Product conducted by or on behalf of Xxxxxxx or its Affiliates during the Manufacturing Improvement Period, as applicable; and (viC) the Parties discuss and address scientific technical or technical other issues arising in the course of any of the Development Programforegoing activities; (vi) to facilitate the transfer of Cidara Know-How to Xxxxxxx contemplated by Section 2.6; (vii) review on a monthly basis (which frequency can be changed to facilitate the transfer of information contemplated by mutual agreement of the Parties) the status of the budget for the conduct of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget in the Development Plan, and the Company’s financial positionSection 5.8; (viii) encourage to facilitate the transfer of Manufacturing Improvements and facilitate cooperation and communication between the Parties with respect Manufacturing Improvement Know-How to the Development ProgramCidara contemplated by Section 5.7(c); (ix) to establish subcommittees, which will report Subcommittees (in addition to the JSC, JMC) as needed it deems necessary or advisable to further the purposes of the Research Program; and, in each case, to delegate to such Subcommittees such of the JSC’s responsibilities (excluding its responsibilities under this AgreementSection 3.1(b)(ix) and Section 3.1(b)(x)) as the JSC deems appropriate, subject to Sections 3.1(f) and 3.3; (x) to resolve disputes referred to it by Subcommittees; and (xxi) perform to carry out such other functions obligations as are expressly delegated to it under this Agreement or as Agreement. Each Party shall be responsible for ensuring that, at all times, its representatives on the Parties agree JSC (and any Subcommittee thereof) act reasonably and in writinggood faith in carrying out their respective responsibilities hereunder.

Appears in 1 contract

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

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Responsibilities and Authority. The JSC’s overall responsibility shall be is to encourage and facilitate ongoing cooperation and communication the exchange of information between the Parties regarding the Development Program and any other activities as contemplated by this Agreement, and to facilitate, coordinate and oversee the development, registration and commercialization of Product in the Field in the Territory. Subject to the terms and conditions The specific responsibilities of this Agreement, the JSC shall have the authority to: (a) Make decisions with respect to the following matters, which are deemed Unanimous Matters (as defined below) for purposes of this Agreementare: (i) reviewto review and discuss any Global Study, discuss and approve any substantive changes or updates to the Development Plan, including the budget and timelines included in the Development Planaccordance with Section 4.1(e); (ii) reviewto review and discuss any Research Plan or amendments or updates thereto, discuss and approve the Company’s protocol, scope and design for any Clinical Trial of a Compound or Product contemplated by the Development Plan, and any material changes theretoin accordance with Section 4.4; (iii) review to discuss Licensee’s development activities (including Clinical Trials) for the Compound and approve (i) the engagement of Third Party subcontractors that are first engaged after the Effective Date to perform work related to the Development Program, or (ii) any new or additional work related to the Development Program, or in preparation for post-Development Program activities, to be performed by any Third Party subcontractor, in each case of clause (i) and (ii), in excess of $[***] in any calendar year or $[***] Products in the aggregate (for clarity, to Field in the extent such amounts are related to the Development Program), including in each case of clause (i) and (ii), (A) any Third Party subcontractors responsible for process development, (B) any Third Party contract manufacturer of any Compound or Product (whether drug substance or drug product), including in preparation for Phase 3 Clinical Trials, or (C) any Third Party contract research organization that would manage any Clinical Trial of any Compound or ProductTerritory; (iv) to review and approve the acquisition discuss amendments or in-license by the Company of any Intellectual Property Controlled by a Third Party that is or would be reasonably likely updates to be necessary or reasonably useful for the exploitation of any Compound or Product; and (v) periodically assess whether the Development Program is commercially reasonable, or scientifically or operationally viable, Plan in accordance with Sections 4.1(b) and determine whether 4.1(c) and to approve amendments to the Development Program should be continued. (b) Consider the following matters: (i) review and discuss Development Program activities, and the results of such activities; (ii) discuss progress reports and other information generated by the Company Plan in performing the Development Program and request other information relating to the progress of the goals or performance of the Development Program; (iii) review and discuss regulatory correspondences and ongoing regulatory strategy relating to any Compound or Product; (iv) review and discuss CMC matters (including process development) relating to any Compound and Productaccordance with Section 4.1(c); (v) review and advise on filingto discuss any Combination Product Plan, prosecution and maintenance strategy for Patents within the Program Technology, including any Patents arising in the Development Program; provided, that such filing, prosecution and maintenance shall be subject to the terms and conditions of the BMS License Agreement, as applicableaccordance with Section 4.6(a); (vi) to review and discuss the Commercialization Plan and address scientific any amendments or technical issues arising updates thereto, in the course of the Development Programaccordance with Section 6.3; (vii) review on a monthly basis to serve as the principal means by which (which frequency can be changed by mutual agreement A) Licensee keeps Verrica reasonably informed regarding the progress and results of Licensee’s development, registration and commercialization efforts for Product in the Field in the Territory, and (B) Verrica keeps Licensee reasonably informed regarding the strategy, plan, progress and results of Verrica’s development, registration, manufacturing and commercialization efforts for Products in the Field in the Verrica Territory and, in accordance with Section 4.3(d), outside of the Parties) the status of the budget for the conduct of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget Field in the Development Plan, and the Company’s financial positionVerrica Territory; (viii) encourage to seek harmonization in global development, regulatory approval, branding, marketing, promotion and facilitate cooperation and communication between the Parties commercialization efforts with respect to Product in the Development ProgramField, including with respect to any Global Study; (ix) to oversee and coordinate the manufacture of Products for use in the Field in the Territory; (x) to review and discuss any Specification Change and Specification Change Plan, in accordance with Section 7.5(b); (xi) to coordinate the Parties’ Product-related activities in relation to international meetings and congresses that will be attended by representatives of both Parties; (xii) to establish subcommittees, which will report to the JSC, subcommittees as needed it deems necessary or advisable to further the purposes of this Agreement, to delegate to such subcommittees such of the JSC’s responsibilities as the JSC deems appropriate, subject to Section 3.3 and Section 3.4, to dissolve subcommittees, and to resolve disputes referred to it by subcommittees; and (xxiii) perform to carry out such other functions obligations as are expressly delegated to it under this Agreement. For clarity, and notwithstanding any other provision of this Article 3 or any other provision of this Agreement to the contrary, the JSC has no decision-making authority of any kind with respect to the development, registration or as commercialization of Compound or Product in the Parties agree in writingVerrica Territory.

Appears in 1 contract

Samples: Collaboration and License Agreement (Verrica Pharmaceuticals Inc.)

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