Good Laboratory Practices Clause Samples

Good Laboratory Practices. “Good Laboratory Practices” shall mean FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth in 21 C.F.R. Part 58 and applicable guidance documents, as well as similar applicable standards in foreign jurisdictions.

Good Laboratory Practices. Standards or requirements established by a regulatory agency to ensure the quality, integrity, maintenance and storage of Regulatory Data in any jurisdiction in which any of the Regulatory Data may be submitted, Referenced, Used, or otherwise relied upon, by way of example, as set forth in the United States Environmental Protection Agency’s regulations at 40 C.F.R. Part 160. U. Initial Notice: Non-confidential notice made to all Signatories that the last United States patent having claims that prevent all uses of the Covered Event as a single Event (id est, a claim that would prevent each and every use of the Event as opposed to a claim that would prevent some but not all uses of the Event) Expires in not less than three (3) years, and that states whether i) the Seed Product containing the Event is a Special Use Product, and ii) the PRP Holder elects to be the Operator under a Comprehensive Agreement.

Good Laboratory Practices. “Good Laboratory Practices” shall mean, as applicable, the current good laboratory practices set forth in Legal Requirements, including (a) the FDCA and its applicable implementing regulations at 21 C.F.R. Part 58; (b) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) and Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version); and (c) other foreign equivalents of the foregoing, in each case, as same may be amended from time to time.

Good Laboratory Practices. The Research Program shall be conducted by VRI at VRI's laboratories. VRI shall use all reasonable efforts to complete research works in accordance with the said Program. Any research work performed by VRI pursuant hereto shall be in compliance with current Good Laboratory Practices (cGLP) as applicable in the United States of America.

Good Laboratory Practices. 3 1.15 HRD.....................................................3 1.16 Improvement.............................................3 1.17 IND.....................................................3 1.18

Good Laboratory Practices. Neither the Company nor any Company Subsidiary have received any written notice or report from any applicable Governmental Entity, including the PRC State Food and Drug Administration, regarding any actual or alleged failure of the Company or the Company Subsidiaries to comply materially with accepted and applicable good laboratory practices (as recognized by the PRC State Food and Drug Administration or such practices analogous to those for nonclinical laboratory studies set forth in regulations issued by the United States Food and Drug Administration and set forth in Title 21 of the Code of Federal Regulations, Part 58, and/or any foreign equivalents thereof) (“Good Laboratory Practices”) with respect to laboratory studies conducted by or on behalf of customers of the Company or the Company Subsidiaries. All nonclinical laboratory studies conducted by the Company or the Company Subsidiaries on behalf of its customers have been conducted in material compliance with applicable Good Laboratory Practices, if such nonclinical laboratory studies were required to be in compliance with Good Laboratory Practices according to the relevant agreements between the Company or any of the Company Subsidiaries and such customers

Good Laboratory Practices. The Sponsor acknowledges that University does not comply with and the Project will not be conducted in accordance with the requirements of 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (the “GLP Regulations”). In any submission by the Sponsor to the U.S. Food and Drug Administration citing the Research, the Sponsor will state that the Research was not intended to be performed in compliance with the GLP Regulations. The Sponsor will indemnify University for all costs and expenses, including attorneys’ fees, incurred in connection with any audit or inspection by the U.S. Food and Drug Administration concerning University’s compliance or noncompliance with the GLP Regulations in the conduct of the research.

Good Laboratory Practices or GLP shall mean the then current Good Laboratory Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.