JSC Formation; Responsibilities Sample Clauses

JSC Formation; Responsibilities. (a) As soon as practicable after the Effective Date, the Parties will form a Joint Steering Committee (the “JSC”). The JSC will meet regularly, but not less than every [**] months, until the Completion of Technology Transfer (at which time the JSC shall disband). The first meeting of the JSC shall be held as soon as practicable after the Effective Date (but not later than approximately forty-five (45) days following the Effective Date). The JSC may also meet more frequently on an ad hoc basis as and to the extent reasonably requested by either Party or if required to perform its role for initial discussion of any disputes in accordance with Section 5.2 and Section 5.3 below. The meetings shall be by telephonic or videoconference, or at a mutually agreed location, at mutually agreed times. Novo Nordisk shall be responsible for its own costs and for both Parties’ travel and accommodation expenses in attending meetings of the JSC. The JSC shall have the authority to establish subcommittees or project teams from time to time, including the joint core project team and the JPC. The JSC will not have the power to amend or waive compliance with, or the terms of, this Agreement. For the avoidance of doubt, the JSC shall have no authority to determine whether a development milestone or sales event under Article 3 has been met. (b) Subject to the Quality Agreement, the JSC shall have the responsibility of managing, directing and overseeing any remaining formulation activities and the conduct of the Technology Transfer process, including, without limitation, the following responsibilities in this regard: (i) establishing the initial Work Plan and any proposed amendments or updates thereto; (ii) managing and monitoring the progress and results of the Technology Transfer activities and the Parties’ diligence in carrying out their responsibilities under the Work Plan; (iii) determining product needs, supply forecasts and timing to allow Novo Nordisk to conduct its toxicological and clinical development program as contemplated under the Work Plan; (iv) managing and monitoring the scale-up of the manufacturing process (if needed and if desired by Novo Nordisk at its sole discretion, subject to Section 4.5) in connection with Technology Transfer activities; and (v) serving as a forum for informal dispute resolution of issues that may arise in relation to purely operational or technical activities engaged in pursuant to this Agreement, including any disputes arising at the J...
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Related to JSC Formation; Responsibilities

  • Union Responsibilities Except for claims resulting from errors caused by defective City equipment, the Union agrees to indemnify and hold harmless the City for any loss or damage arising from the operation of this Article.

  • Association Responsibilities The Association shall have, in addition to other responsibilities expressly set forth herein or provided by law, the following responsibilities:

  • Construction Responsibilities The party named in Article 1, Responsible Parties, under AGREEMENT is responsible for the following: A. Advertise for construction bids, issue bid proposals, receive and tabulate the bids, and award and administer the contract for construction of the Project. Administration of the contract includes the responsibility for construction engineering and for issuance of any change orders, supplemental agreements, amendments, or additional work orders that may become necessary subsequent to the award of the construction contract. In order to ensure federal funding eligibility, projects must be authorized by the State prior to advertising for construction. B. If the State is the responsible party, the State will use its approved contract letting and award procedures to let and award the construction contract. C. If the Local Government is the responsible party, the Local Government shall submit its contract letting and award procedures to the State for review and approval prior to letting. D. If the Local Government is the responsible party, the State must concur with the low bidder selection before the Local Government can enter into a contract with the vendor. E. If the Local Government is the responsible party, the State must review and approve change orders. F. Upon completion of the Project, the party responsible for constructing the Project will issue and sign a “Notification of Completion” acknowledging the Project’s construction completion and submit certification(s) sealed by a professional engineer(s) licensed in the State of Texas. G. For federally funded contracts, the parties to this Agreement will comply with federal construction requirements cited in 23 CFR Part 635 and with requirements cited in 23 CFR Part 633, and shall include the latest version of Form “FHWA-1273” in the contract bidding documents. If force account work will be performed, a finding of cost effectiveness shall be made in compliance with 23 CFR 635, Subpart B.

  • Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

  • IRO Responsibilities The IRO shall: 1. perform each Claims Review in accordance with the specific requirements of the CIA;

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • User Responsibilities i. Users are required to follow good security practices in the selection and use of passwords; ii. Users shall ensure that unattended equipment is protected; and iii. Users shall adopt a clear desk policy for papers and removable storage media and a clear screen policy for information processing facilities.

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly XXXXX Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • CITY’S RESPONSIBILITIES 2.1. The CITY shall designate in writing a project coordinator to act as the CITY's representative with respect to the services to be rendered under this Agreement (the "Project Coordinator"). The Project Coordinator shall have authority to transmit instructions, receive information, interpret and define the CITY's policies and decisions with respect to the CONTRACTOR's services for the Project. However, the Project Coordinator is not authorized to issue any verbal or written orders or instructions to the CONTRACTOR that would have the effect, or be interpreted to have the effect, of modifying or changing in any way whatever: (a) The scope of services to be provided and performed by the CONTRACTOR; (b) The time the CONTRACTOR is obligated to commence and complete all such services; or (c) The amount of compensation the CITY is obligated or committed to pay the CONTRACTOR. Any such modifications or changes ((a) (b) or (c)) shall only be made by or upon the authorization of the CITY’s city manager as authorized by city council in the enabling legislation or in the CITY’s procurement policies. 2.2. The Project Coordinator shall: (a) Review and make appropriate recommendations on all requests submitted by the CONTRACTOR for payment for services and work provided and performed in accordance with this Agreement; (b) Arrange for access to and make all provisions for the CONTRACTOR to enter the Project site to perform the services to be provided by the CONTRACTOR under this Agreement; and (c) Provide notice to the CONTRACTOR of any deficiencies or defects discovered by the CITY with respect to the services to be rendered by the CONTRACTOR hereunder. 2.3. The CONTRACTOR acknowledges that access to the Project Site, to be arranged by the CITY for the CONTRACTOR, may be provided during times that are not the normal business hours of the CONTRACTOR.

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

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