Introduction and Submission
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Preparation and Submission The Recipient will:
Introduction and Background 1.1 The purpose of this Schedule 2 (Contract Services and Contract Supplies) is to set out the characteristics of the Contract Services and/or Contract Supplies (as the case may be) and Funding that the Provider will be required to make available to all Contracting Authorities in relation to Lot 1 and/or Lot 2 (as the case may be) and to provide a description of what the Contract Services and/or Contract Supplies (as the case may be) and Funding will entail.
Introduction and Statement of Policy The National Institutes of Health (NIH) has established NIH-designated data repositories (e.g., database of Genotypes and Phenotypes (dbGaP), Sequence Read Archive (SRA), NIH Established Trusted Partnerships) for securely storing and sharing controlled-access human data submitted to NIH under the NIH Genomic Data Sharing (GDS)
Introduction and Purpose The Kentucky Community and Technical College System (KCTCS) and the Kentucky Department of Education (KDE) mutually support the attainment of dual credit coursework for high school students. This Memorandum of Understanding (MOU) underscores the dedication of both agencies to improving the educational attainment of Kentucky citizens and reinforces the collaboration necessary to achieve this level of success. Improving the educational attainment of Kentucky citizens is key to ensuring the State’s long-term success. The State commits significant resources across the educational spectrum to develop and implement strategies to address this critical issue. Providing secondary students dual credit opportunities is a proven educational strategy with the capacity to complement and maximize the chances of success of our educational initiatives. Effective dual credit systems have impacts both at the secondary and postsecondary levels and provide the opportunity for collaboration. Participants are expected to know and follow current and future versions of Dual Credit Policies established by the Kentucky Council on Postsecondary Education found at: xxxx://xxx.xx.xxx/policies/dualcredit.html. Should policies change during the academic year, KCTCS may request support in meeting those changes outside the scope of this document.
Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).
NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this CIA shall be submitted to the following entities: OIG: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, X.X. Washington, DC 20201 Telephone: 000.000.0000 Facsimile: 202.205.0604 GSK: Xxxxxxx X. Xxxx Vice President & Compliance Officer North America Pharmaceuticals GlaxoSmithKline Three Franklin Plaza 000 X. 00xx Xxxxxx Xxxxxxxxxxxx, XX 00000 Telephone: 000.000.0000 Facsimile: 215.751.7547 Unless otherwise specified, all notifications and reports required by this CIA may be made by certified mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. For purposes of this requirement, internal facsimile confirmation sheets do not constitute proof of receipt. Upon request by OIG, GSK may be required to provide OIG with an electronic copy of each notification or report required by this CIA in searchable portable document format (pdf), either instead of or in addition to, a paper copy.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
EVALUATION AND MONITORING The ORGANIZATION agrees to maintain books, records and other documents and evidence, and to use accounting procedures and practices that sufficiently and properly support the complete performance of and the full compliance with this Agreement. The ORGANIZATION will retain these supporting books, records, documents and other materials for at least three (3) calendar years following the year in which the Agreement expires. The COUNTY and/or the State Auditor and any of their representatives shall have full and complete access to these books, records and other documents and evidence retained by the ORGANIZATION respecting all matters covered in and under this Agreement, and shall have the right to examine such during normal business hours as often as the COUNTY and/or the State Auditor may deem necessary. Such representatives shall be permitted to audit, examine and make excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, and records of matters covered by this Agreement. These access and examination rights shall last for three calendar years following the year in which the Agreement expires. The COUNTY intends without guarantee for its agents to use reasonable security procedures and protections to assure that related records and documents provided by the ORGANIZATION are not erroneously disclosed to third parties. The COUNTY will, however, disclose or make this material available to those authorized by/in the above paragraph or permitted under the provisions of Chapter 42.56 RCW without notice to the ORGANIZATION. The ORGANIZATION shall cooperate with and freely participate in any other monitoring or evaluation activities pertinent to this Agreement that the COUNTY finds needing to be conducted.
Investigation and Prevention Transfer Agent shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to:
PUBLICATION AND PUBLICITY The CONSULTANT agrees that it shall not for any reason whatsoever communicate to any third party in any manner whatsoever concerning any of its CONTRACT work product, its conduct under the CONTRACT, the results or data gathered or processed under this CONTRACT, which includes, but is not limited to, reports, computer information and access, drawings, studies, notes, maps and other data prepared by and for the CONSULTANT under the terms of this CONTRACT, without prior written approval from the COMMISSION, unless such release or disclosure is required by judicial proceeding. The CONSULTANT agrees that it shall immediately refer any third party who requests such information to the COMMISSION and shall also report to the COMMISSION any such third party inquiry. This Article shall not apply to information in whatever form that comes into the public domain, nor shall it restrict the CONSULTANT from giving notices required by law or complying with an order to provide information or data when such order is issued by a court, administrative agency or other authority with proper jurisdiction, or if it is reasonably necessary for the CONSULTANT to defend itself from any suit or claim. All approved releases of information, findings, and recommendations shall include a disclaimer provision and all published reports shall include that disclaimer on the cover and title page in the following form: The opinions, findings, and conclusions in this publication are those of the author(s) and not necessarily those of the Mississippi Department of Transportation, Mississippi Transportation Commission, the State of Mississippi or the Federal Highway Administration.
