definiens: or means Good Laboratory Practices as promulgated by the FDA under and in accordance with the FD&C Act ( Title 21 of the U.S. Code, Section 342 et seq ), Title 21, Part 58 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time to time, or any successors thereto . To the extent consistent with U.S. law, also includes the principles of good laboratory practice as set out in Directives 2004/9 / EC and 2004/10 / EC ( as supplem ented by the OECD Principles of Good Laboratory Practices ), all applicable national implementing legislation and guidelines, and all applicable equivalent regulatory requirements of a Regulatory Authority in any country or jurisdiction in the Territory, as each may be amended from time to time, or any successors thereto