definiens: ), or within the meaning ofany state or municipal laws in the United States applicable to the Drug Product and containing terms with substantially similarmeanings as the meaning of adulteration or misbranding under the Act ; provided, however, that this paragraph shall not applyto, and PCD shall have no responsibility for, misbranding caused directly by SPI as a result of labels or package texts specifiedor provided by SPI for the Drug Product ; and PCD shall have no responsibility for issues of regulatory and legal compliancethat are the responsibility of SPI, including but not limited to ( 1 ) maintaining a complete and valid NDA for the product, ( 2)ensuring that the product specifications are consistent with the NDA, and ( 3 ) ensuring that the product is stored and distributedin the SPI9 Territory in a manner that does not result in its becoming adulterated, misbranded, or otherwise in violation of law