Shionogi Authority and Responsibilities Sample Clauses

Shionogi Authority and Responsibilities. Subject to the terms and conditions of this Agreement, Shionogi shall have sole authority in the Territory with respect to (i) filing and maintaining INDs; (ii) obtaining Regulatory Approvals for Products and subsequently maintaining such Regulatory Approvals; (iii) communicating with Regulatory Authorities about Products; and (iv) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions. Shionogi shall keep the JDC reasonably informed regarding the status and progress of such activities at its regularly scheduled meetings.
AutoNDA by SimpleDocs

Related to Shionogi Authority and Responsibilities

  • Authority and Responsibility A. DBEs and other small businesses are strongly encouraged to participate in the performance of Contracts financed in whole or in part with federal funds (See 49 CFR 26, “Participation by Disadvantaged Business Enterprises in Department of Transportation Financial Assistance Programs”). The Consultant must ensure that DBEs and other small businesses have the opportunity to participate in the performance of the work that is the subject of this solicitation and should take all necessary and reasonable steps for this assurance. The proposer must not discriminate on the basis of race, color, national origin, or sex in the award and performance of subcontracts. B. Consultants are encouraged to use services offered by financial institutions owned and controlled by DBEs.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Licensee Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.

  • Position and Responsibilities During the term of Executive’s employment hereunder, Executive agrees to serve as an Executive Vice President of the Bank. Executive shall perform administrative and management services for the Bank which are customarily performed by persons in a similar executive officer capacity. During said period, Executive also agrees to serve as an officer and director of any subsidiary of the Bank or the Company, if elected.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.

  • 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.

  • Role and Responsibilities During the Employment Period, the Executive shall serve as Chief Financial Officer of the Company, and shall perform such employment duties as are usual and customary for such position. The Executive shall report directly to the Chief Executive Officer of the Company (the “CEO”). At the Company’s request, the Executive shall serve the Company and/or its subsidiaries and affiliates in other capacities in addition to the foregoing, consistent with the Executive’s position hereunder. In the event that the Executive, during the Employment Period, serves in any one or more of such additional capacities, the Executive’s compensation shall not be increased beyond that specified in Section 2(b) hereof. In addition, in the event the Executive’s service in one or more of such additional capacities is terminated, the Executive’s compensation, as specified in Section 2(b) hereof, shall not be diminished or reduced in any manner as a result of such termination provided that the Executive otherwise remains employed under the terms of this Agreement.

  • School Responsibilities Pursuant to §1002.33(8)(e), F.S., the School shall be dissolved under the provisions of law under which the School was organized. Student records and copies of all administrative, operational, and financial records of the School shall be provided to the Sponsor on the date the termination/non-renewal takes effect.

  • 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.

  • RESTRICTIONS AND RESPONSIBILITIES 2.1 Customer will not, directly or indirectly: reverse engineer, decompile, disassemble or otherwise attempt to discover the source code, object code or underlying structure, ideas, know-how or algorithms relevant to the Services or any software, documentation or data related to the Services (“Software”); modify, translate, or create derivative works based on the Services or any Software (except to the extent expressly permitted by Company or authorized within the Services); use the Services or any Software for timesharing or service bureau purposes or otherwise for the benefit of a third; or remove any proprietary notices or labels. With respect to any Software that is distributed or provided to Customer for use on Customer premises or devices, Company hereby grants Customer a non-exclusive, non-transferable, non-sublicensable license to use such Software during the Term only in connection with the Services. 2.2 Further, Customer may not remove or export from the United States or allow the export or re-export of the Services, Software or anything related thereto, or any direct product thereof in violation of any restrictions, laws or regulations of the United States Department of Commerce, the United States Department of Treasury Office of Foreign Assets Control, or any other United States or foreign agency or authority. As defined in FAR section 2.101, the Software and documentation are “commercial items” and according to DFAR section 252.227-7014(a)(1) and (5) are deemed to be “commercial computer software” and “commercial computer software documentation.” Consistent with DFAR section 227.7202 and FAR section 12.212, any use modification, reproduction, release, performance, display, or disclosure of such commercial software or commercial software documentation by the U.S. Government will be governed solely by the terms of this Agreement and will be prohibited except to the extent expressly permitted by the terms of this Agreement. 2.3 Customer represents, covenants, and warrants that Customer will use the Services only in compliance with Company’s standard published policies then in effect (the “Policy”) and all applicable laws and regulations. Customer hereby agrees to indemnify and hold harmless Company against any damages, losses, liabilities, settlements and expenses (including without limitation costs and attorneys’ fees) in connection with any claim or action that arises from an alleged violation of the foregoing or otherwise from Customer’s use of Services. Although Company has no obligation to monitor Customer’s use of the Services, Company may do so and may prohibit any use of the Services it believes may be (or alleged to be) in violation of the foregoing. 2.4 Customer shall be responsible for obtaining and maintaining any equipment and ancillary services needed to connect to, access or otherwise use the Services, including, without limitation, modems, hardware, servers, software, operating systems, networking, web servers and the like (collectively, “Equipment”). Customer shall also be responsible for maintaining the security of the Equipment, Customer account, passwords (including but not limited to administrative and user passwords) and files, and for all uses of Customer account or the Equipment with or without Customer’s knowledge or consent. 2.5 Customer may opt out of these Terms and Conditions, but doing so will terminate Services.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!