definiens: means the first marketing approval by any Regulatory Authority for the drug product containing APL means ( i ) any and all permits, licenses, filings and certifications required by the US Food and Drug Administration ( FDA ), US Occupational Safety and Health Administration ( OSHA ), US Environmental Protection Agency ( EPA ), The International Conference ofHarmonization Q7 ( ICH Q7 ), The United States Pharmacopeia, ( USP ), The European Pharmacopeia ( EP ), the European Medicines Agency ( EMEA ), and compliance with the cGMP ofthe FDA, ICH Q7, USP, EP and EMEA, applicable to any manufacturing or processing activities hereunder or facilities at which any ofthe manufacturing or processing activities hereunder are performed, and ( ii ) any Laws, rules, guidelines, regulations, and standards of any governmental authority within the United States ( including, without limitation, EPA, OSHA, the Drug Enforcement Administration ( DEA ) and state and local authorities ), that apply to any manufacturing or processing activities hereunder or the Facility or other facilities at which any ofthe manufacturing or processing activities hereunder are performed