Independent Trial definition

Independent Trial means a Trial, which has not been agreed by the Parties to be a Global Trial as Joint Development Activity in accordance with Section 3.5. For clarity, an Independent Trial may be conducted in countries in either or both the Co-Commercialization Territory and the COMPANY Territory, provided that (i) such Independent Trial has been reviewed and discussed in the JDC, (ii) any Non-NDA Study is subject to approval under Section 9.2(e), and (iii) such Independent Trial has been included into the Development Plan.
Sample 1Sample 2
Independent Trial is defined in Section 4.3.3.2 hereof.
Sample 1
Independent Trial has the meaning set forth in Section 4.5 (Independent Development).
Sample 1

Examples of Independent Trial in a sentence

  • There will be an Independent Trial Steering Committee (TSC) as per NIHR guidelines including an independent Chair, at least two further trials experts, an independent statistician and PPIE members.

  • The IDMC is advisory to the Independent Trial Steering Committee (TSC) and can recommend premature closure of the trial to the TSC.

  • The IDMC will make confidential recommendations to the Trial Steering Committee (TSC).• Independent Trial Steering Committee (TSC): The TSC will be a committee of independent members that provides overall supervision of the trial.

  • Membership of the Trial Steering Committee: Independent Trial Steering CommitteeDr Megan Thomas (Independent Expert and Chair), Dr Nigel Coad (Independent Expert), Mrs Sandra Cope (Independent Consumer Representative), Dr Andrew Duncan (Independent Expert), Dr Darren Green (Independent Expert), Dr Ly-Mee Yu (Independent Expert Statistician).

  • Independent Trial Determination1Crop1 All assessments are based on the replicate trial guidance presented in draft memo 568_Criteria for Independence of Trials 04/23/2013 (EPA) and final memo Criteria for Independence of Crop Field Trials November 2014 (PMRA).

  • The history of the advocacy for teaching of nature of science (NOS) in science classrooms is very long and is evidenced by the National Society for the Study of Education (1960) and Hurd (1960) who claim the existence of this goal in American schools as early as 1920 (Karakas, 2010).

  • Independent Trial Determination1CropTrial Nos.DifferencesDecisionGreen onionOH*17, OH*18Same locationVariety: Evergreen white bunching (70-day maturity, 2-3” whiteshanks) vs.

  • In this case, the 6 For more information please see International Centre for Trade Unions Rights, Independent Trial Observer Report, available at http://www.ictur.org/pdf/Plunkett.pdfThai Courts had no jurisdiction as the Al Jazeera interview was given in another country and not in Thailand.7 During Andy Hall's trial from May to July 2016, challenges concerning adequacy and capability of translators both for Hall and defense witnesses arose frequently.

  • It follows that these developments have also contributed to the reduction in labor.

  • In the event ZARS proposes to conduct a clinical trial for a ZARS New Indication or a ZARS Product Enhancement in the Galderma Territory (each, a “ZARS Independent Trial”), ZARS shall provide to Galderma a copy of the proposed protocol for such trial at least sixty (60) days prior to the commencement of the ZARS Independent Trial.


More Definitions of Independent Trial

Independent Trial shall have the meaning set out in Section 4.7.5.
Sample 1
Independent Trial means the Trials set forth on Schedule 1.102 and any Trial deemed to be an Independent Trial in accordance with Section 3.5. For clarity, an Independent Trial may be conducted in countries in either or both the Co-Commercialization Territory and the Incyte Territory, provided that (a) such Independent Trial has been reviewed and discussed in the JDC, and (b) such Independent Trial has been included in the Development Plan.
Sample 1

Related to Independent Trial

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Independent physician means a physician who is chosen by the resident of the assisted living facility and who has no financial interest in the assisted living facility, directly or indirectly, as an owner, officer, or employee or as an independent contractor with the residence.

  • Independent Party means, with respect to a BDC Downstream Fund, (i) if the BDC Downstream Fund has a board of directors (or the equivalent), the board or (ii) if the BDC Downstream Fund does not have a board of directors (or the equivalent), a transaction committee or advisory committee of the BDC Downstream Fund.

  • Independent Tax Counsel means a lawyer, a certified public accountant with a nationally recognized accounting firm, or a compensation consultant with a nationally recognized actuarial and benefits consulting firm with expertise in the area of executive compensation tax law, who shall be selected by the Board, and whose fees and disbursements shall be paid by the Company.

  • Independent Third Party means any Person who, immediately prior to a contemplated transaction, does not own in excess of 5% of the Company’s Common Units on a fully-diluted basis (a “5% Owner”), who is not controlling, controlled by or under common control with any such 5% Owner and who is not the spouse or descendant (by birth or adoption) of any such 5% Owner or a trust for the benefit of such 5% Owner and/or such other Persons.

  • Independent review organization means an entity that is accredited to conduct independent external reviews of adverse benefit determinations.

  • Joint Remediation Committee has the meaning set forth in Section II.A.2.

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;

  • Independent student means one whose parents have surrendered the right to his care, custody and

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Joint Patent Committee or “JPC” has the meaning set forth in Section 7.1.3(a).

  • Independent Person means a person appointed under section 28(7) of the 2011 Act;

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Independent provider means a self-employed person who provides services for which he or she must be certified in accordance with rule 5123:2-2-01 of the Administrative Code and does not employ, either directly or through contract, anyone else to provide the services.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Independent Auditors has the meaning set forth in Section 3.2.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • JSC has the meaning set forth in Section 3.1.

  • Independent Verification means that an evaluation is undertaken and reported by an individual or body whose organisation, systems and procedures conform to ISO Guide 65:1996 (EN 45011:1998) General requirements for bodies operating product certification systems (as amended form time to time) or equivalent, and who is accredited to audit against forest management standards by a body whose organisation, systems and procedures conform to ISO 17011: 2004 General Requirements for Providing Assessment and Accreditation of Conformity Assessment Bodies (as amended from time to time) or equivalent.

  • Licensed Independent Practitioner means any individual permitted by law and by the Medical Staff and Board to provide care and services without direction or supervision, within the scope of the individual’s license and consistent with individually granted clinical privileges.

  • Independent school means a school which is an efficient school within the meaning of the School Education Act 1999 and which is not administered by or on behalf of the Government of Western Australia.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Steering Committee shall have the meaning set forth in Section 3.1.