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.
Independent Trial has the meaning set forth in Section 4.5 (Independent Development).
Independent Trial is defined in Section 4.3.3.2 hereof.

Examples of Independent Trial in a sentence

  • Within fifteen (15) days of the Sponsoring Party’s receipt of the Non-Sponsoring Party’s payment, the Independent Data generated in such Independent Trial, including the final study report, shall be provided to the Non-Sponsoring Party.

  • 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.

  • The Party proposing to conduct such Independent Trial may proceed with such trial (as described in its notice to the other Party) after such sixty (60) day notice period unless such other Party reasonably and in good faith objects to such protocol on the grounds that it would cause, or would have an unreasonable risk of causing, a material adverse effect upon the Development or Commercialization of a Licensed Product containing the same Compound.

  • ZARS shall be responsible for filing, in its own name and at its own expense, any IND in connection with any ZARS Independent Trial and shall have the right to access, reference and use all of Galderma’s, its Affiliates’ or Sublicensees’ Data, regulatory filings and regulatory communications associated with any MXXx or other approvals for a Product in the Galderma Territory in accordance with Section 4.5(b) and Section 4.8 in connection with any such Trial.

  • ZARS shall retain ownership of all the Data generated by ZARS in connection with any ZARS Independent Trial and shall have the same rights of access and use to any MAA filed by Galderma in connection with this Section 4.2(b) as with respect to the Initial MAA pursuant to Section 4.5(b).


More Definitions of Independent Trial

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.
Independent Trial shall have the meaning set out in Section 4.7.5.

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 Employer and shall be reasonably acceptable to the Executive, and whose fees and disbursements shall be paid by the Employer.

  • 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.

  • 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 of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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.

  • Negotiating Committee means a three-member group comprised by representatives of the following: (1) the State; and (2) two representatives of Local Governments of which one representative will be from a Municipality and one shall be from a County (collectively, “Members”) within the State. The State shall be represented by the Attorney General or her designee.

  • 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, other than a public school, at which the compulsory attendance requirements of Section 59-65-10 may be met and that does not discriminate based on the grounds of race, color, religion, or national origin.

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).