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.
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 [**...
Responsibilities of the JSC. The JSC, subject to Sections 4.5 and 4.6, shall oversee and supervise the overall Collaboration and the relationship between the Parties hereunder, and within such scope shall:
4.4.1.1. define the Collaboration goals and strategic direction;
4.4.1.2. prioritize Projects and respective activities;
4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectively;
4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT;
4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders;
4.4.1.6. approve the Model and the Primary Screening Assay for each Project;
4.4.1.7. approve the deconvolution of the target for each Project;
4.4.1.8. if applicable, determine lead candidate criteria and development candidate criteria for a Project, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable;
4.4.1.9. endorse Lead Candidate Criteria and Development Candidate Criteria achievement and other Lead Candidate and Development Candidate selections, always provided that the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria or Lead Candidate and Development Candidate selection is confirmed by the Bayer Criteria Committee in accordance with Section 4.8;
4.4.1.10. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds to be included in a Lead Series;
4.4.1.11. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable wind-down period which shall not exceed [***] months in case the Project is discontinued;
4.4.1.12. form such other committees or working groups as the JSC may deem appropriate, provided that such committees may make recommendations to the JSC but may not be delegated JSC decision-maki...
Responsibilities of the JSC. The primary purpose of the JSC will be to provide oversight and strategic planning for the Project being carried out under the Agreement. Specific JSC responsibilities shall include: • Prioritization of activities in Project Plan (and between Project Plans if more than one is in place at any time); • Resolving any issues that cannot be resolved by the Project Team, as provided in Section 4.1(d); • Establishing a Commercialization Strategy, as provided in Section 6.1; and • Recommending to the Party’s appropriate signatories the execution of any significant amendments or modifications to the Project Plan submitted to the JSC by the Project Team pursuant to Section 3.2, including any associated financial terms or modifications to the Payment Plan.
Responsibilities of the JSC. The JSC shall:
Responsibilities of the JSC. Within thirty (30) days after the Effective Date, the JSC shall be responsible for developing a charter that describes its activities and responsibilities in greater detail. The JSC shall function as a forum (a) for the Parties to inform and consult with one another concerning progress of the Research and Development of Licensed Products, and (b) to review, approve, monitor and suggest revisions to (as the JSC deems appropriate) the Research Plans and the Joint Development Plans, as applicable. Without limiting the generality of the foregoing, the JSC shall be responsible for:
(i) approving strategy and monitoring the Research and Development of Licensed Products under the Research Plans and Joint Development Plans; and (ii) reviewing and approving a pharmacovigilance plan.
Responsibilities of the JSC. In addition to its other responsibilities and activities expressly described in this Agreement and the LLC Agreement, the JSC shall have the responsibility and authority to: (a) monitor and oversee all aspects of the Development and Commercialization of Products under this Agreement; (b) agree upon, adopt and/or amend or modify the Development Plans, Commercialization Plans and Product Participation Models, and all updates or amendments thereto; (c) establish and approve budgets for the activities of the Operating Parties under this Agreement to be included in the Development Plans and Commercialization Plans; (d) establish subcommittees pursuant to Section 4.3, and address disputes or disagreements arising in any subcommittee so established; (e) serve as the initial forum for discussion of and attempts to resolve any disputes or disagreements between the Operating Parties relating to this Agreement; (e) approve the design of clinical trials for studies that form the basis of Regulatory Filings; (f) oversee the Regulatory Approval process for all Products and create mechanisms for interaction of the Operating Parties with respect to submission of Regulatory Filings; (g) coordinate efforts of the Operating Parties to assure proper reporting of all adverse events; (h) develop standard operating procedures for addressing customer inquiries and complaints; (i) make decisions in such other matters pertaining to the implementation of this Agreement as may be necessary; and (j) perform such other functions as the Parties may agree in writing.
Responsibilities of the JSC. The JSC shall have the responsibility and authority to:
(a) review and comment on any Development being conducted by either Party;
(b) provide a forum for discussing any development relating to the Product being conducted by VIVUS (or its sublicensees) outside the Auxilium Territory;
(c) review and comment on marketing and sales activities being carried out by Auxilium in the Auxilium Territory, including review of the Commercialization and Medical Affairs Plans;
(d) provide a forum for discussing marketing and sales activities being conducted by VIVUS (or its sublicensees) outside the Auxilium Territory;
(e) review and discuss any manufacturing or supply issues that may arise;
(f) coordinate the efforts of the Parties with respect to the Label Expansion Filing;
(g) Establish subcommittees pursuant to Section 3.6 on an as-needed basis, oversee the activities of all subcommittees so established, and address disputes or disagreements arising in all such subcommittees; and
(h) Perform such other functions as the Parties may agree in writing.
Responsibilities of the JSC. In addition to its general responsibility to oversee and coordinate the development of Compounds and Products in the Field according to the Global Research and Development Plan and ensure a regular flow of research and development information between the Parties, the JSC shall in particular:
(a) develop the Global Research and Development Plan and the Annual Development Plan and Budget for the remainder of calendar year 1999 and for calendar year 2000 within sixty (60) days after the Effective Date;
(b) review and update as necessary the Global Research and Development Plan and develop an Annual Development Plan and Budget for activities under the Global Research and Development Plan for subsequent calendar years no later than the October 31 immediately preceding each such subsequent calendar year;
(c) oversee the activities of each Party's project team that is performing such Party's obligations under the Research Program;
(d) facilitate the flow of information between the Parties with respect to all development work being conducted for each Compound and Product in the Field on a worldwide basis;
(e) review and approve all scientific and clinical protocols, which shall provide that all preclinical and clinical development work under this Agreement shall be conducted in accordance with GLPs and GCPs;
(f) review and approve the contents and filing of INDs, applications for Regulatory Approval, and related and supporting submissions to Regulatory Authorities; and
(g) until such time as the MSC is formed, review and approve premarketing activities and expenses.
Responsibilities of the JSC. The Parties shall be jointly responsible for directing the activities of the JSC, which activities shall include but not be limited to
(a) the review, validation, material modification, update and amendment of the Development Plans;
(b) the monitoring of the Development activities under the Development Plans;
(c) the exchange of Development Data and other technical information; EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL EXECUTION VERSION
(d) the resolution of any disputes within the Joint Project Team; and
(e) the coordination of patents and other intellectual property rights applications regarding Joint Inventions. For the avoidance of doubt, the JSC is not permitted to change any terms of this Agreement.
