Local Study definition

Local Study means any Clinical Trial for any Product in the Field and which (a) Zai determines to conduct and is conducted by or on behalf of Zai in the Territory, and (b) does not include clinical sites in any country or jurisdiction outside the Territory.
View Source
Local Study means any Clinical Trial for any Licensed Product in the Field and which (a) Licensee determines to conduct and is conducted by or on behalf of Licensee in the Licensed Territory, and (b) does not include clinical sites in any country or jurisdiction outside the Licensed Territory.
View Source
Local Study means any Territory-specific registrational studies that are conducted by a Licensee Entity or, to the extent set forth in Section 4.01(b), by an Ocular Entity, in the Territory with respect to the Licensed Product; but excluding all Global Studies.
View Source

Examples of Local Study in a sentence

  • Each Local Study conducted in the Territory shall be conducted in accordance with the Clinical Development Plan, the study protocol approved by any relevant Regulatory Authority, and Applicable Laws in the Territory.

  • Licensee shall be solely responsible for performing any Local Study at its sole cost (including handling relevant Regulatory Filings for any Local Studies in the Licensed Territory at its own cost, as applicable, in accordance with Article 6).

  • Each Local Study conducted in the Territory shall be conducted in accordance with the relevant Development Plan, the study protocol approved by the JSC and any relevant Regulatory Authority, and Applicable Laws in the Territory.

  • Licensee shall be solely responsible for and use Commercially Reasonable Efforts (subject to Section 4.1.2) to perform any Local Studies (including handling relevant Regulatory Filings for any Local Study at its own cost, as applicable, in accordance with Article 5).

  • Each Local Study conducted in the Territory shall be conducted in accordance with the Development Plan, the study protocol approved by any relevant Regulatory Authority, and Applicable Laws in the Territory.

  • Zenas may initiate (subject to Section 4.4.2(a)), suspend, or cease (subject to Section 3.1.3(e)) a Global Study anywhere in the world for any Product for any Indication, in its sole discretion; provided, that where such ceased Global Study is a Joint Global Study, Licensee shall have the option, in its sole discretion and subject to Section 3.1.5, to reinstate such Global Study in the Territory as a Local Study.

  • If required by any Regulatory Authority, Zenas shall have the right to audit any Local Study sites in the Territory, and Licensee shall have the right to be present at and participate in any such audit to the extent permitted by such Regulatory Authority.

  • Zai shall use Commercially Reasonable Efforts, be solely responsible for and have decision-making authority for performance of any Local Study (including handling relevant Regulatory Submissions for any Local Studies in the Territory at its own cost, as applicable, in accordance with ARTICLE 6); provided [***].

  • Each Local Study conducted in the Licensed Territory shall be conducted in accordance with the Clinical Development Plan, the study protocol approved by any relevant Regulatory Authority, and Applicable Laws in the Licensed Territory.

  • Any subcontractor engaged by Licensee to undertake any such Local Study (or any portion thereof) shall be qualified in the Territory and shall be capable of producing, storing and maintaining data that is acceptable to the applicable Regulatory Authority.


More Definitions of Local Study

Local Study means [***] [***].
View Source
Local Study has the meaning set forth in Section 4.2.3.
View Source

Related to Local Study

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]