definiens: means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of ClinicalTrials ( as defined in the License Agreement ), as conducted within or outside theTerritory ( as defined in the License Agreement ), including, as applicable ( a ) as setforth in the International Conference on Harmonization of Technical Requirementsfor Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guidelinefor Good Clinical Practice ( CPMP / ICH/135/95 ) and any other applicable guidelinesfor good clinical practice for trials on medicinal products, ( b ) the Declaration ofHelsinki ( 2004 ) as last amended at the 52nd World Medical Association in October2000 and any further amendments or clarifications thereto, ( c ) 21 C.F.R. Parts 50(Protection of Human Subjects ), 56 ( Institutional Review Boards ) and 312(Investigational New Drug Application ), as may be amended from time to time, and(d ) the equivalent applicable Laws in the Territory ( as defined in the LicenseAgreement ), each as may be amended and applicable from time to time and in eachcase, that provide for, among other things, assurance that the clinical data andreported results are credible and accurate and protect the rights, integrity, andconfidentiality of trial subjects