1.“Confidential Information” means any scientific, technical information which is treated by A as confidential or proprietary including, without limitation, manufacturing process, route of synthesis, methods of analysis, formulations, techniques, methodology, assay systems, formulae, procedures, tests, equipment, clinical protocols, data, reports, know-how. This confidential information will be provided by A, who has it already available, in form of Drug Master File (- Hereinafter referred to as the DOCUMENTATION -).
1.“保密信息”指任何A认为是保密或专有的科学技术信息,包括但不限于生产工艺、合成路线、分析方法、处方、技术、方法学、分析制度、公式、程序、试验、设备、临床方案、数据、报告、窍门。这些保密信息由A以DMF文件(以下称为DOCUMENTATION)的形式提供。
2.The disclosure of the Confidential Information and the DOCUMENTATION by A to B shall be subject to and conditional upon the following obligations on the part of and undertakings by B :
2.1To treat and hold the Confidential Information and the DOCUMENTATION as strictly confidential. To use it exclusively to apply for or extend the registration of the medicinal Products containing the SUBSTANCE with the competent authorities. Will not use the Confidential Information and the DOCUMENTATION for any other commercial purposes without the prior written consent of A.
2.保密信息的公开以及A给B提供DOCUMENTATION应当以B履行以下义务为条件:
2.1将保密信息和DOCUMENTATION严格保密,仅用于含有SUBSTANCE的制剂在官方的注册。保密信息和DOCUMENTATION不得在未经A 事先书面允许的情况下用于任何其他商业目的。