definiens: means current good manufactur ing practices applicable to the Manufacture of Product as follows : ( i ) current good manufacturing practices promulgated by the FDA, as specified in the United States Code of Fede ral Regulations and FDA ’s guidance documents, as such practices govern the Manufacture of Product intended for use in the United States ; ( ii ) current good manufacturing practices as defin ed in the Q7A Guidance on Good Manufacturing Practices of the International Conference on Harmon ization of Technical 2 Requirements of Pharmaceuticals for Human Use ( ICHQ 7A ) and other ICH guidelines applicable to the manufacture of the drug substance ; ( iii ) curren t good manufacturing practices or equivalent standards promulgated by Regulatory Authorities of Japan ; and ( iv ) current good manufacturing practices or equivalent standards promulgated by su ch other countries of the Territory in which Product is intended to be supplied, used, marketed or sold and which other countries are agreed to in writing between the Parties, such agreement not to be unreasonably withheld, conditioned or delayed