definiens: means current good m anufacturing practices applicable to the Manufactur e of Product as follows : ( a ) current good manufacturing practices p romulgated by the FDA, as specified in the United S tates Code of Federal Regulations and FDA ’s guidance documents, as such practices gover n the Manufacture of Product intended for use in the United States ; ( b ) current good manufacturing practices as defined in the Q7A Guidance on Good Manufacturing Practices of the Internationa l Conference on Harmonization of Technical Requirem ents of Pharm aceuticals for Human Use ( ICHQ7A ) and other ICH gui delines applicable to the Manufacture of the drug substance ; ( c ) current good manufacturing practices or equivalent standards promulgated by Regulatory Authorities of Japan ; and ( d ) current good manufact ur ing practices or equivalent standards promulgated b y such other countries of the Territory in which Product i s intended to be supplied, used, marketed or sold a nd which other countries are agreed to in writing between th e Parties, such agreement not to be unreasonably withheld, conditioned or delayed