Responsibilities of the JMC Sample Clauses

Responsibilities of the JMC. The Joint Manufacturing Committee shall be responsible for performing the following functions: (a) coordinate with the JDC and JCC to ensure adequate quantity, quality, and timeliness of supply of Collaboration Products to meet clinical and commercial needs worldwide; (b) review and approve the initial plans (and any subsequent amendments) specified in the MDSA with regard to Manufacturing activities for the Collaboration Product, including the CMC Development Plan, Manufacturing Network Plan, Technology Transfer Plans and any other plan recommended by the JMT and approved by the JMC; in all cases, ensuring that the activities thereunder are performed in accordance with the MDSA, Quality Agreement and JMC-approved performance targets, timelines and budgets; (c) review progress of, and provide guidance with respect to, CMC development activities and associated costs as reported by the JMT pursuant to the approved CMC Development Plan and annual budget; (d) approve and oversee the development and implementation of the Manufacturing Process for clinical and commercial supply of Collaboration Product in accordance with the MDSA, applicable Quality Agreement, JMC-approved performance targets, timelines and budgets and [***]; (e) approve and oversee, with respect to clinical and commercial supply of Collaboration Product, the Technology Platform Strategy and Manufacturing Operations Strategy; (f) oversee and monitor, with respect to Commercial Facilities within the Manufacturing Network, the progress of the activities required for construction, Mechanical Completion, Commissioning, Start-up (including Technology Transfer) and Licensure by the applicable Regulatory Authority; (g) review and oversee the performance by Third Parties of certain Manufacture or supply obligations in accordance with the MDSA and applicable Quality Agreement; (h) review and approve business processes for aligning patient demand forecast requirements with Manufacturing supply planning and scheduling requirements, and assess and resolve gaps between demand, and supply and Capacity plans; (i) investigate and advise on Manufacturing, supply and quality issues; (j) review, at least semi-annually, the performance under the MDSA by the Parties; (k) review and recommend for approval by the Parties any changes to the MDSA, applicable Quality Agreement, Commercial Manufacturing Agreement or other subsequent agreement related to Manufacturing of Collaboration Product, each as proposed by the JMT; ...
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Responsibilities of the JMC. The JMC shall:
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Responsibilities of the JMC. The JMC shall perform the following functions: (a) serve as a forum for the discussion of the overall Manufacturing strategies and plans for the Collaboration, including [***]; (b) review and approve the Manufacturing plans included in a Development Plan or Commercialization Plan, including with respect to Manufacturing process, physical product, Manufacturing and technology transfer, supply chain for launch and commercial supply and solutions for technical issues; (c) assist the JRDC, and where applicable, the JCC and JSC, in review and approval of the Development Budget or Commercialization Budget to the extent relating to Manufacturing activities; (d) provide recommendations to JSC for the selection of CMOs for Commercial Manufacturing and the terms and conditions of the proposed CMO agreement; and (e) perform such other functions as are specifically designated to the JMC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.
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Responsibilities of the JMC. The JMC shall: (i) discuss manufacturing matters with respect to the Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product, including the Manufacturing Process, and discuss and seek approval of the Approved CMO (as more fully set forth in Section 7.1); (ii) facilitate the sharing of the Rolling Forecasts and Long Term Forecasts pursuant to Section 7.2(e)(i), and review and seek approval of the Annual Global Supply Commitment pursuant to Section 7.3(a);
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Related to Responsibilities of the JMC

  • Responsibilities of the Parties 1.5.1 The Parties shall perform all obligations of this Agreement in accordance with all Applicable Laws and Regulations, Operating Requirements, and

  • RESPONSIBILITIES OF THE OWNER The Owner agrees to: Provide all documentation, records, and disclosures as required by law or required by the Agent to manage and operate the Property, and immediately notify the Agent if the Owner becomes aware of any change in such documentation, records or disclosures, or any matter affecting the habitability of the Property; Indemnify, defend, and hold harmless the Agent, and all persons in the Agent's firm, regardless of responsibility, from all costs, expenses suits, liabilities, damages, attorneys fees, and claims of every type, including, but not limited to, those arising out of injury or death of any person, or damage to any real or personal property of any person, including the Owner, for: Any repairs performed by the Owner or by others hired directly by the Owner; or Those relating to the management, leasing, rental, security deposit, or operation of the Property by the Agent, or any person in the Agent's company, or the performance or exercise of any of the duties, powers, or authorities granted to the Agent; This sub-section, and all rights to the Agent’s indemnification, shall be considered void if the Agent exemplifies any willful acts of gross negligence; Maintain the Property in a condition fit for human habitation as required by applicable State and local laws; Pay all interest on Tenants’ security deposits if required by applicable laws; Carry and pay for: Public and premises liability insurance in an amount of no less than one-million dollars ($1,000,000.00); and Property damage and worker’s compensation insurance adequate to protect the interests of the Owner and the Agent. The Agent shall be, and the Owner authorizes Agent to be, named as an additional insured party on the Owner’s policies; and Pay any late charges, penalties and/or interest imposed by lenders or other parties for failure to make payment only if the failure is due to insufficient funds in the Agent’s trust account available for such payment. In addition, the Owner agrees to replace any funds required if there are insufficient funds in the Agent’s trust account to cover such responsibilities of the Owner.

  • Responsibilities of the Company 3.3.1 The Company shall provide participants of CopyTrade with a complete package of services according to the Customer Agreement. The Company is liable for proper performance of technological solutions according to the Customer Agreement. 3.3.2 The Company bears no liability to participants of CopyTrade for lost profit or losses, which may directly or indirectly occur as a result of trading operations performed or not performed by an Investor or a Trader. 3.3.3 The Company bears no liability to participants of CopyTrade for lost profit or losses, which may be directly or indirectly occur as a result of their ignorance of regulatory documents or cooperation scheme. 3.3.4 The Company doesn’t evaluate Traders’ professional skills and suitability not on a single stage of their activity and bears no responsibility to Investors for any losses or lost profit they may incur. 3.3.5 The Company is not liable for:

  • RESPONSIBILITIES OF CITY City or its representative shall issue all communications to Contractor. City has the authority to request changes in the work in accordance with the terms of this Agreement and with the terms in Exhibit A – Scope of Work. City has the authority to stop work or to suspend any work.

  • RESPONSIBILITIES OF THE STATE 3.2.1 The State will identify a Project Manager for the Project. The Project Manager will be the sole point of contact between the Contractor and the State. The Project Manager will be the State’s representative authorized to communicate the State’s position and directions related to all contract work and to coordinate all change orders with the Commissioner of Buildings and General Services as deemed necessary. 3.2.2 If applicable, the State shall furnish all surveys describing the physical characteristics, legal limitations and utility locations for the site of the Project, and a legal description of the site. 3.2.3 Except as provided in Subparagraph 4.7.1, the State shall secure and pay for necessary approvals, easements, assessments and charges required for the construction, use or occupancy of permanent structures or for permanent changes in existing facilities. 3.2.4 Information or services under the State's control shall be furnished by the State with reasonable promptness to avoid delay in the orderly progress of the Work. 3.2.5 Unless otherwise provided in the Contract Documents, the Contractor will be furnished, free of charge, all copies of Drawings and Specifications reasonably necessary for the execution of the Work. 3.2.6 The State shall forward instructions to the Contractor through the Architect. 3.2.7 The foregoing are in addition to any other duties and responsibilities of the State enumerated in the Contract Documents including those responsibilities described in Articles 6, 9 and 11 of this agreement. 3.2.8 The State may utilize a Clerk-of-the-Works to provide inspection and monitoring work on behalf of the State. If a Clerk-of-the-Works is utilized, it is the responsibility of the Architect and the Contractor to review and understand the Clerk’s duties, responsibilities and limitations of authority. Upon request, the State shall provide a copy of the Clerk-of-the-Works contract to Architect and Contractor.

  • RESPONSIBILITIES OF THE UNIVERSITY The UNIVERSITY shall designate in writing a faculty member to coordinate with a designee of the FIELDWORK SITE.

  • Responsibilities of the City The City’s Contract Manager will be responsible for exercising general oversight of the Contractor’s activities in completing the Scope of Work. Specifically, the Contract Manager will represent the City’s interests in resolving day-to-day issues that may arise during the term of this Contract, shall participate regularly in conference calls or meetings for status reporting, shall promptly review any written reports submitted by the Contractor, and shall approve all invoices for payment, as appropriate. The City’s Contract Manager shall give the Contractor timely feedback on the acceptability of progress and task reports.

  • Responsibilities of the Contractor The Contractor shall provide all technical and professional expertise, knowledge, management, and other resources required for accomplishing all aspects of the tasks and associated activities identified in the Scope of Work. In the event that the need arises for the Contractor to perform services beyond those stated in the Scope of Work, the Contractor and the City shall negotiate mutually agreeable terms and compensation for completing the additional services.

  • RESPONSIBILITIES OF PARTIES A. BST will include billing number information associated with resold exchange lines or SPNP arrangements in its LIDB. The Local Exchange Company will request any toll billing exceptions via the Local Service Request (LSR) form used to order resold exchange lines, or the SPNP service request form used to order SPNP arrangements. B. Under normal operating conditions, BST shall include the billing number information in its LIDB upon completion of the service order establishing either the resold local exchange service or the SPNP arrangement, provided that BST shall not be held responsible for any delay or failure in performance to the extent such delay or failure is caused by circumstances or conditions beyond BST’s reasonable control. BST will store in its LIDB an unlimited volume of the working telephone numbers associated with either the resold local exchange lines or the SPNP arrangements. For resold local exchange lines or for SPNP arrangements, BST will issue line-based calling cards only in the name of Local Exchange Company. BST will not issue line- based calling cards in the name of Local Exchange Company’s individual end users. In the event that Local Exchange Company wants to include calling card numbers assigned by the Local Exchange Company in the BST LIDB, a separate agreement is required. C. BST will provide responses to on-line, call-by-call queries to the stored information for the specific purposes listed in the next paragraph. D. BST is authorized to use the billing number information to perform the following functions for authorized users on an on-line basis: 1. Validate a 14 digit Calling Card number where the first 10 digits are a line number or special billing number assigned by BST, and where the last four digits (PIN) are a security code assigned by BST. 2. Determine whether the Local Exchange Company has identified the billing number as one which should not be billed for collect or third number calls, or both.

  • Responsibilities of the Borrower (a) Anything herein to the contrary notwithstanding, the Borrower shall: (i) perform all of its obligations, if any, under the Contracts related to the Pool Receivables to the same extent as if interests in such Pool Receivables had not been transferred hereunder, and the exercise by the Administrative Agent, or any other Credit Party of their respective rights hereunder shall not relieve the Borrower from such obligations and (ii) pay when due any taxes, including any sales taxes payable in connection with the Pool Receivables and their creation and satisfaction. None of the Credit Parties shall have any obligation or liability with respect to any Collateral, nor shall any of them be obligated to perform any of the obligations of the Borrower, the Servicer or any Originator thereunder. (b) Alliance hereby irrevocably agrees that if at any time it shall cease to be the Servicer hereunder, it shall act (if the then-current Servicer so requests) as the data-processing agent of the Servicer and, in such capacity, Alliance shall conduct the data-processing functions of the administration of the Receivables and the Collections thereon in substantially the same way that Alliance conducted such data-processing functions while it acted as the Servicer. In connection with any such processing functions, the Borrower shall pay to Alliance its reasonable out-of-pocket costs and expenses from the Borrower’s own funds (subject to the priority of payments set forth in Section 4.01).

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