Sponsor Responsibilities definition

Sponsor Responsibilities means those responsibilities assigned by the applicable Regulatory Authority to the sponsor or the holder of a regulatory filing with respect to the conduct of human clinical trials, such as an IND, as specified in 21 CFR 312, Subpart D, or any foreign equivalent thereof. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Examples of Sponsor Responsibilities in a sentence

  • Sponsor Responsibilities (7 CFR 225.14)Sponsors must:Demonstrate Financial and Administrative Capability: Potential and returning sponsors are required to demonstrate that they have the necessary financial and administrative capability to comply with Program requirements.

  • To define Sponsor Responsibilities in the conduct of Investigator driven studies.

  • Sponsor Responsibilities (1) The sponsor shall submit an application on forms provided by the District (Urban Drainageway Program Application, Form 17.17, Manual of Standard Forms, Appendix E).

  • Section 7.1 - Definitions lists definitions, Section 7.3 - Investigator Responsibilities gives details of the investigator responsibilities and Section 7.4 - Sponsor Responsibilities provides information on sponsor responsibilities.

  • Plan Sponsor Responsibilities When applying for the plan, on its renewal or in the event of any changes to the plan (including adding members to the plan), the plan sponsor or such person acting on its behalf must, in accordance with Section 3 of the UK Insurance Act 2015, make a fair presentation of the risk to be insured by us under the plan.

  • Sponsor Responsibilities The sponsor for the study will be a representative from SpinTech, Inc.

  • The employer acknowledges receipt of the Summary of Plan Sponsor Responsibilities and agrees to fulfill its responsibilities as stated therein.

  • Funds would become available following Board approval of the budget, normally at the beginning of the CVR‐SAFE fiscal year.Project Sponsor Responsibilities Project sponsors would be required to submit a standard application for CVR‐SAFE grant funding.

  • Post Implementation Federal and Non-Federal Sponsor Responsibilities.

  • After IDE obtained by sponsor, proceed to review study applying requisite criteria [21 CFR 56.111] (2) Sponsor Responsibilities: a.

Related to Sponsor Responsibilities

  • Customer Responsibilities means the responsibilities of the Customer set out in paragraph 6.1 of the Order Form;

  • Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the University, which may include for example: activities such as research, research consultation, teaching, professional practice, University committee memberships, and service on panels such as Institutional Review Boards or data and safety monitoring boards.

  • Responsibilities means the responsibilities delegated to BNY under the Rule as a Foreign Custody Manager with respect to each Specified Country and each Eligible Foreign Custodian selected by BNY, as such responsibilities are more fully described in Article III of this Agreement.

  • Financial responsibility means the ability to respond in damages for liability thereafter incurred

  • extended producer responsibility ’ (EPR) means responsibility of any producer of packaging products such as plastic, tin, glass, wrappers and corrugated boxes, etc., for environmentally sound management, till end-of-life of the packaging products ;

  • TAXPAYERS' RIGHTS AND RESPONSIBILITIES means the rights provided to taxpayers in sections 718.11 , 718.12 , 718.19, 718.23, 718.36, 718.37, 718.38, 5717.011 , and 5717.03 of the Ohio Revised Code and any corresponding ordinances of the Municipality, and the responsibilities of taxpayers to file, report, withhold, remit, and pay municipal income tax and otherwise comply with Chapter 718. of the Ohio Revised Code and resolutions, ordinances, and rules adopted by a municipal corporation for the imposition and administration of a municipal income tax.

  • Residual parental rights and responsibilities means all rights and responsibilities remaining with the

  • Area of responsibility means the geographical area, as

  • Corporate Social Responsibility means Corporate Social Responsibility (CSR) as defined in Section 135 of the Companies Act, 2013 and Companies Corporate Social Responsibility Policy) Rules, 2014;

  • parental responsibility , in relation to a child, means all the duties, powers, responsibilities and authority which, by law, parents have in relation to children.

  • Proof of financial responsibility means proof of ability to respond in damages for liability, on account of accidents occurring after the effective date of the proof, arising out of the ownership, maintenance, or use of a motor vehicle, in the amount of twenty-five thousand dollars because of bodily injury to or death of one person in any one accident, and, subject to the limit for one person, in the amount of fifty thousand dollars because of bodily injury to or death of two or more persons in any one accident, and in the amount of twenty-five thousand dollars because of injury to or destruction of property of others in any one accident.

  • Official responsibility means administrative or operating authority, whether intermediate or final, to initiate, approve, disapprove or otherwise affect a procurement transaction, or any claim resulting therefrom.

  • Designated crisis responder means a mental health

  • State sponsor of terrorism means a country determined by the Secretary of State, under section 6(j)(1)(A) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j)(i)(A)), to be a country the government of which has repeatedly provided support for acts of international terrorism. As of the date of this provision, state sponsors of terrorism subject to this provision are Iran, Sudan, and Syria. (10 U.S.C. 2327)

  • Independent Fiduciary means an independent fiduciary who will serve as a fiduciary to the Plan in accordance with Article 3 that has no relationship or interest in any of the Settling Parties and is mutually agreed to by the Settling Parties.

  • Oversight means the term as it is defined in the Stewardship Agreement between CDOT and the FHWA.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Role means the part or parts an Actor plays in a performance, or the "track" that an Artist follows in performance. The Artist may agree to participate in scene changes and/or supplemental business as part of their originally contracted Role.

  • Scope of Services or “Scope of Work” means the work to be performed by the Proposer or Consultant as described in Section 2.0 of this RFP, as amended thereto.

  • Project Sponsor means an eligible governmental agency receiving program funds pursuant to an approved application.

  • Transition means: 1) the formal and physical process of transferring from school to school or 2) the period of time in which a student moves from one school in the sending state to another school in the receiving state.

  • Agency Chief Contracting Officer or “ACCO” shall mean the position delegated authority by the Agency Head to organize and supervise the procurement activity of subordinate Agency staff in conjunction with the City Chief Procurement Officer.

  • Services Coordinator means an employee of the community developmental disability program or other agency that contracts with the county or Division, who is selected to plan, procure, coordinate, monitor Individual Support Plan services, and to act as a proponent for individuals with developmental disabilities.

  • Investor Relations Activities means any activities, by or on behalf of the Company or a shareholder of the Company, that promote or reasonably could be expected to promote the purchase or sale of securities of the Company, but does not include:

  • Managing general agent or "MGA" means any person who:

  • Implementation Letter means the letter of even date herewith from the Borrower to the Bank setting forth the Project monitoring indicators;