Steering Committee Responsibilities. The Steering Committee shall have the following responsibilities, as well as any additional responsibilities expressly set forth in this Agreement:
(i) receiving and reviewing reports and data received from a Party from time to time as set forth herein, including without limitation the submission of Proposed Genes, data related to the murine homology of Proposed Genes, results of the First Pass Phenotypic Analysis and [**];
(ii) receiving notices from the Parties as set forth herein, including without limitation notices of delays or stalled research pursuant to Section 3.3(a);
(iii) the designation of Project Genes and Protein Candidates under Sections 3.1 and 3.5, respectively;
(iv) coordinating the activities of the Parties hereunder;
(v) developing and implementing a publicity strategy and policy for the review and approval of press releases and publications in accordance with Section 9.4;
(vi) settling disputes or disagreements that arise between the parties as set forth in Article 13; and
(vii) performing such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.
Steering Committee Responsibilities. In addition to and without limiting the general oversight functions described above, the Steering Committee shall perform the following functions specific to Maruho’s Development and Commercialization of Product in the Field and Territory (other than the function described in Section 3.2.7 which is specific to Journey’s development and Commercialization):
3.2.1. review and approve the Development Plan and any proposed amendments to the Development Plan;
3.2.2. review and approve the following, for which Xxxxxx will prepare summaries, each with sufficient detail regarding, as applicable, general strategy, dosing, efficacy, safety, and inclusion and exclusion criteria: (a) any non-clinical studies and protocols and any non-clinical study report conclusions; (b) any clinical trial protocols and any clinical study report conclusions, (c) any Regulatory Filing, and (d) any scientific publication or public presentation regarding [***] or Product. With respect to the approval process under Section 3.2.2, at Xxxxxx’s discretion, the applicable summary may be sent directly to Journey’s Steering Committee members and if such Steering Committee members have not responded within seven (7) Business Days, then the applicable approval shall be deemed given by Journey’s Steering Committee members. Maruho shall provide the summaries in English, but shall not be obligated to translate the underlying protocols and documents identified in Section 3.2.2, provided Maruho shall continue to be obligated to maintain and make available such protocols and documents in accordance with Section 4.4;
3.2.3. review any material quality issues with respect to the Product that may impact Journey’s or Xxxxxx’s development and Commercialization of the Product, and discuss any necessary remedial action to be undertaken with respect thereto;
3.2.4. review any material changes to the manufacturing of [***] or Products, or any material updated information (including Improvements) which are necessary or useful with respect thereto, for which each Party will endeavor to disclose such information to the JSC in a timely manner;
3.2.5. review and discuss any changes, modification or amendment to the specifications set forth on Schedule D attached hereto (the “Specification” or “Specifications”) and any material changes thereto, which Maruho shall provide to the Steering Committee on a timely basis.
3.2.6. review and approve the commercialization plan and proposed amendments to the commercialization p...
Steering Committee Responsibilities. The Steering Committee shall (i) be a forum for the parties’ review and discussion of, and facilitate the exchange of information and analysis relating to, OST’s Research and Development activities, as provided in this Agreement; (ii) monitor OST’S Research and Development activities under this Agreement pursuant to any plans or strategies approved by the Steering Committee; and (iii) have any additional responsibilities as expressly delegated to it under this Agreement or as mutually agreed upon by the parties in writing on a case-by-case basis. In addition, the Steering Committee shall, during the R&D Term:
A. Review and approve the R&D Plan for the COG Study and any other Studies, including any amendments thereto and any additional R&D Plans. Notwithstanding any other provision herein, any changes or modifications to the applicable approved protocol for a Study must be documented in an amended R&D Plan approved by the Steering Committee;
B. Review and approve all Regulatory Filings and other communications with Regulatory Authorities prior to submission thereof with a Regulatory Authority; and
C. Review any reported safety issues, including adverse events reported pursuant to Section 4.2(d);
D. Review and discuss the performance by OST of its activities in the OST Operational Plan in support of the COG Study, and make recommendations to amend the OST Operational Plan; and
E. Establish or amend the responsibilities of, and resolve all disputes referred to by, the Safety Subcommittee.
Steering Committee Responsibilities. The Steering Committee shall have the duty and authority to perform the functions described above and the following additional functions:
(a) General oversight of the activities of the Parties under this Agreement, including the progress of work under each Development Plan.
(b) Review of quarterly reports before such reports are sent to the Parties regarding the progress of the Parties’ efforts under each Development Plan.
(c) Review of the technology budget and quarterly spending in connection with each Development Plan.
Steering Committee Responsibilities. The Steering Committee shall be responsible for overseeing and managing the collaboration, including, without limitation the following functions:
(a) determining the overall strategy for the Development, manufacturing and Commercialization of all Collaboration Products in the manner contemplated by this Agreement;
(b) establishing a governance structure for and coordinating the activities of the Parties hereunder including, to the extent necessary, establishing certain operating committees to oversee certain activities such as Development, finance, manufacturing and Commercialization (the operating committees shall be subordinate to the Steering Committee and shall include individuals with expertise and responsibilities in the relevant areas);
(c) reviewing and approving the Program Plan;
(d) reviewing the activities and Collaboration Expenditures compared to the Program Plan and determining whether any changes are necessary, given the then-current progress and results;
(e) approving target product profiles for Collaboration Products, including indications, in addition to peripheral arterial occlusion (PAO), for which the Collaboration Products will be further Developed and Commercialized;
(f) determining which Collaboration Products will be Developed and Commercialized;
(g) facilitating the exchange of all data, Information, Materials or results relating to Collaboration Products, including developing report formats to facilitate the respective activities and responsibilities of the Parties; and
(h) performing such other functions as appropriate to further the purposes of the collaboration as determined by the Parties.
Steering Committee Responsibilities. The Steering Committee shall, in addition to its other responsibilities described in this Agreement: (a) prepare one or more written plans for advancing the research and development of the Licensed Product (each, a “Research Plan”) in the Territory, and provide oversight on the research, development and performance of the Research Plan; (b) prepare and, as necessary amend, the Research Plan, coordinate the activities of the Parties under this Agreement and the implementation, performance, completion and monitoring of the Parties’ activities rendered pursuant to the Research Plan; (c) support the Parties’ development and implementation of a strategy for obtaining and maintaining Regulatory Approvals for, and commercializing, the Products in the Territory; (d) strategize and execute on Company’s business development efforts with respect to the development and commercialization of the Licensed Product, including with respect to the identification of prospective Sublicensee(s) of Company in the Territory to advance the development and/or commercialization of the Licensed Product in the Territory; (e) establish such subcommittees as deemed appropriate by the Steering Committee; (f) identify and, as applicable engage, one or more manufacturers capable of supplying the Parties with clinical and/or commercial quantities of Products; and (g) take such other actions as the Steering Committee may agree.
Steering Committee Responsibilities. The Steering Committee shall have the following responsibilities, as well as any additional responsibilities expressly set forth in this Agreement:
(i) receiving and reviewing reports and data received from a Party from time to time as set forth herein, including without limitation the submission of Proposed Genes, data related to the murine homology of Proposed Genes, results of the First Pass Phenotypic Analysis, data and results related to any Advanced Phenotypic analysis (including any Advanced Phenotypic Panels) and Overexpression Analysis;
(ii) receiving notices from the Parties as set forth herein, including without limitation notices of delays or stalled research pursuant to Section 3.3;
(iii) the designation of Project Genes and Protein Candidates under Sections 3.1 and 3.5, respectively;
(iv) the selection of Project Genes for Advanced Phenotypic Analysis and the Advanced Phenotypic Panels to be conducted on such Project Genes under Section 3.6,
(v) the designation or selection, as applicable, of Genentech Advanced Research Protein Candidates and Lexicon Advanced Research Protein Candidates under Section 3.7;
(vi) overseeing and, as required, approving the actions of the Joint Project Team with respect to Pre-Clinical Development, Clinical Development and Co-Promotion;
(vii) coordinating the activities of the Parties hereunder;
(viii) developing and implementing a publicity strategy and policy for the review and approval of press releases and publications in accordance with Section 9.4;
(ix) settling disputes or disagreements that arise between the Parties hereunder and as set forth in Article 14: ; and
(x) performing such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.
Steering Committee Responsibilities. The Steering Committee shall, in addition to its other responsibilities described in this Agreement: (a) provide oversight on the development and performance of the Research Plan (as defined below); (b) prepare and, as necessary amend, the Research Plan, coordinate the activities of the Parties under this Agreement and the implementation, performance, completion and monitoring of the Parties’ activities rendered pursuant to the Research Plan; (c) support the Parties’ development and implementation of a strategy for obtaining and maintaining Regulatory Approvals for, and commercializing, the Products in the License Territory; (d) strategize and execute on Company’s business development efforts with respect to the development and commercialization of the Product, including with respect to the identification of prospective Third Party sublicensee(s) of Company in the License Territory to advance the development and/or commercialization of the Product in the License Territory; (e) establish such subcommittees as deemed appropriate by the Steering Committee; (f) identify and, as applicable engage, one or more Third Party manufacturers capable of supplying the Parties with clinical and/or commercial quantities of Products; and (g) take such other actions as the Steering Committee may agree.
Steering Committee Responsibilities. Subject to Section 3.4, the Steering Committee shall perform the following functions:
(a) overseeing the development and commercialization, and as set forth herein the manufacture, of Products in the North American Territory;
(b) reviewing the Development Plan and Commercialization Plan;
(c) reviewing and allocating resources and efforts for the development of Products for the North American Territory and commercialization of Products in the Co-Promote Territory;
(d) performing such other functions referred to in the Development Plan and/or Commercialization Plan, or as otherwise specified in this Agreement or agreed to by the Parties.
Steering Committee Responsibilities. MUTUAL RESPONSIBILITIES
A. CFS will serve as lead agency of the Steering Committee and may appoint a new chairperson from the Steering Committee participants facilitating the collaboration and assisting the Steering Committee’s continued work towards achieving the goals of the CASE plan.
B. Members will include executive level staff from each of the 10 agencies named in this MOU.
C. Oversee the accomplishment of MHSA PEI goal of increasing recognition of early signs of mental illness and reducing prolonged suffering amongst the target population; and measuring outcomes, including increased public awareness of CSEC issues and availability of resources, increased knowledge and identification of CSEC youth by agency staff and the utilization and reporting of CANS pre and post assessments.
D. Continuous evaluation of program outcomes and implementation of effective methods for measuring CASE services will be reviewed regularly.
E. Provides ongoing oversight and support to ensure the county agencies and partners effectively collaborate to better identify and serve CSEC and youth at risk in becoming CSEC.
F. Develop Interagency Protocol (“Protocol”).
G. Implement the Protocol, oversee implementation, and revise as needed.
H. Provide input to the County on how to utilize CSEC Program funding.
I. Collect and analyze aggregate data related to the Protocol.
J. Assess the sufficiency of CSEC specific resources in the county.
K. Identify training needed (e.g. basic identification and awareness training and training on responsibilities under the interagency protocol) and ensure necessary training occurs.
L. Provide an annual report to State on the number of children served, the services received, promising practices, and any identified gaps in services and resources.
M. Build consensus and determine project objectives towards the CASE Plan through a majority vote, when quorum is present. Each agency will have one voting member with the exception of the Superior Court who is a non-voting member. A quorum is 50% of the voting members of the Steering Committee.
N. Maintain and strengthen a collaborative strategic plan consisting of outreach and education, and prevention and intervention initiatives.
O. Oversee education, training and capacity building activities to County and contractor staff, and other stakeholders and/or relevant agencies. Additionally, all Parties agree that it is the responsibility of each department to ensure respective staff attends appropriate trai...
