definiens: means ( i ) obtaining and maintaining any and all permits, licenses, fili ngs and certifications required by the Regulatory Autho rities, ( ii ) compliance with the cGMPs of the Regul atory Authorities, applicable to any manufacturing or pro cessing activities hereunder or the CSBS Facility o r other facilities at which any of the Manufacturing Proces s is performed, and ( iii ) any laws, rules, guidelin es, regulations, guidance, points to consider documents and standards of any Governmental Authority, wheth er within or outside the United States ( including, wit hout limitation, the Environmental Protection Agenc y ( EPA ), the Occupational Safety and Health Administration ( OSHA ), the Drug Enforcement Administration ( DEA ) an d state and local authorities ), that apply to the Man ufacturing Process or CBSB Facility or other facili ties at which any of the Manufacturing Process is performed