Investigational Agent definition

Investigational Agent or “Investigational New Drug” means, in accordance with the definition in 21 C.F.R. § 312.3, a new drug or biological drug that is used in a clinical investigation. For this Agreement, Investigational Agent means Collaborator’s proprietary investigational agents as listed in Attachment A, provided by or on behalf of Collaborator. For the purpose of this CRADA, Investigational Agent(s) will be referred to as “Formulary Agent(s)”.
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Investigational Agent or Investigational New Drug means, in accordance with the definition in 21 C.F.R. § 312.3, a new drug or biological drug that is used in a clinical NCI DCTD CRADA model adopted October 14, 2011 Case Ref. No. 00-0-00000 Page 5 of 33 Confidential
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Investigational Agent means, for purposes of this CRADA, and in accordance with 21 C.F.R. § 312.3 , the drug candidate 1-methyl-D-tryptophan (also known as 1MT, or NSC721782), which is provided by or on behalf of Collaborator.
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Examples of Investigational Agent in a sentence

  • Store and maintain separate NCI Investigational Agent Accountability Records for each agent, strength, formulation and ordering investigator on this protocol.

  • Collaborator will provide DCTD with a copy of its Annual Report to the FDA if Collaborator is sponsoring studies of Investigational Agent under its own IND.

  • If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD has the right to make Clinical Data in ICD’s Possession and Control available to a third party.

  • The investigator, or a responsible party designated by the investigator, must maintain a careful record of the receipt, dispensing and final disposition of all agents received from the PMB using the appropriate NCI Investigational Agent (Drug) Accountability Record (DARF) available on the CTEP forms page.

  • Furthermore, NCI agrees that no analysis or modification of the Investigational Agent will be performed without Collaborator’s prior written consent.

  • Collaborator will provide a Certificate of Analysis to DCTD for each lot of the Investigational Agent provided.

  • DCTD does not maintain country-specific Investigational Agent supplies.

  • DCTD and Collaborator are also interested in evaluating Investigational Agent in combination with other novel investigational agents.

  • Collaborator further agrees to provide draft Investigational Agent labels to the NCI Pharmaceutical Management Branch (PMB) for review and agrees to reasonable labeling revisions to comply with DCTD label guidelines.

  • The option to elect a co-exclusive license shall apply when a CRADA Subject Invention is also a CRADA Subject Invention under another CRADA resulting from mutually agreed upon studies as described in Article 8.9 and the field of use of this co-exclusive license shall be to the use of the combination of the Investigational Agent with another agent(s) commensurate with the scope of the Research Plan.

Related to Investigational Agent

  • Additional Agent means any one or more agents, trustees or other representatives for or of any one or more Additional Credit Facility Creditors, and shall include any successor thereto, as well as any Person designated as an “Agent” under any Additional Credit Facility.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Authorised Authority Representative means the Authority representative named in CCN as authorised to approve agreed Variations to the Contract.

  • Investigation means the Bureau’s decision to hold and not process the Company’s license renewal applications identified in Appendix A due to the Company’s inability to certify compliance with its public file obligations.

  • Authority Representative means the representative appointed by the Authority from time to time in relation to this Framework Agreement;

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Investigations The Xxxxxxx, when requested by one or a number of employees whom he/she represents, may investigate the basis for any dispute arising under this Agreement and may, at any stage, assist the employee(s) in seeking resolution of such dispute through the grievance procedure provided herein. A staff representative of the Union may substitute in place of the Xxxxxxx at the third step (Agency Head) or sooner if the agency is represented by other than the supervisor or intermediate supervisor. The Union may substitute a Union staff person in place of the Xxxxxxx if the Xxxxxxx is not available.

  • investigating authority means an authority that in terms of national legislation may investigate unlawful activities;

  • County Representative means the individual obligated to perform the duties of county representative under section 9.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Educational Agency As defined in Education Law 2-d, a school district, board of cooperative educational services, school, charter school, or the New York State Education Department.

  • Authority’s Representative means the individual authorised to act on behalf of the Authority for the purposes of the Contract.

  • Investigating Officer means the person appointed by the Monitoring Officer to undertake a formal investigation of a complaint alleging a breach of the Code of Conduct by a Subject Member. The Investigating Officer may be another senior officer of the District Council, an officer of another authority or an external investigator.

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;

  • Agency Representative A person assigned by a primary, assisting, or cooperating federal, state, local, or tribal government agency or private entity that has been delegated authority to make decisions affecting that agency’s or organization’s participation in incident management activities following appropriate consultation with the leadership of that agency. Area: The lands in a described geographic area that are managed and/or protected by the Parties within this Agreement.

  • Contractor Representative means any of the following:

  • EXPERIMENTAL OR INVESTIGATIONAL means any healthcare service that has progressed to limited human application, but has not been recognized as proven and effective in clinical medicine. See Experimental or Investigational Services in Section 3 for a more detailed description of the type of healthcare services we consider experimental or investigational.

  • District Representative means the Superintendent of the District, or any other person authorized by the Governing Board of the District to act on behalf of the District under or with respect to this Facilities Lease.

  • public representative means an individual who is not a member, former member, student or former student of any accounting body;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Loan Parties’ Agent means Xxxxxxxx Group Holdings Limited (formerly known as Rank Group Holdings Limited).

  • Gestational age or "gestation" means the age of an unborn child as calculated from the first day of the last menstrual period of a pregnant woman;

  • Principal’s Representative means the person nominated by the Principal or other person from time to time appointed in writing by the Principal to act as the Principal’s Representative for the purposes of the Contract.

  • Investigative information means information, records, and documents received or generated by a physical therapy licensing board pursuant to an investigation.

  • Governmental Agency(ies) means, individually or collectively, any federal, state, county or local governmental department, commission, board, regulatory authority or agency (including, without limitation, each applicable Regulatory Agency) with jurisdiction over the Company or a Subsidiary.

  • clinical investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;