definiens: ), or within the meaning of any state or munic ipal laws in the United Kingdom applicable to the D rug Product and containing terms with substantially sim ilar meanings as the meaning of adulteration or mis branding under the Act ; provided, however, that this paragra ph shall not apply to, and RTU shall have no respon sibility for, misbranding caused directly by SPE as a result of labels or package texts specified or provided b y SPE for the Drug Product ; and RTU shall have no responsibil ity for issues of regulatory and legal compliance t hat are the responsibility of SPE, including but not limited to ( 1 ) maintaining a complete and valid NDA for the p roduct, ( 2 ) ensuring that the product specifications are consis tent with the NDA, and ( 3 ) ensuring that the produc t is stored and distributed in the SPE Territory in a manner th at does not result in its becoming adulterated, mis branded, or otherwise in violation of law