definiens: or means current practices for the Manufacture of Products required : ( A ) if the Manufacturing Site is within the European Union or the Product is to be supplied to a country within the European Union, by the provisions of Chapter II of EC Commission Directive 2003/94 / EC together with the Guide to Good Manufacturing Practice pub lished by the EC Commission in 1992 ( ISBN 92 -826 - 3180 -X ) ( as the same may be amended from time to time ) ; or ( B ) if the Product is to be supplied to a region covered by the International Conference on Harmonisation of Technical Requirements for Regist ration of Pharmaceuticals for Human Use ( ), by the relevant ICH Quality Guidelines relating to good manufacturing practice ( as the same may be amended from time to time ) ; or ( C ) if the Manufacturing Site is in any other part of the world and the Product is not to be supplied to a country within the European Union, by such standards as may be agreed in writing between the Parties to reflect the requirements of a Regulatory Authority in the country where the Product is Manufactured or supplied ; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [ * * * ], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD . HAS DETERMINED THE INFORMATION ( I ) IS NOT MATERIAL AND ( II ) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD . IF PUBLICLY DISCLOSED