definiens: means, with respect to a Drug Product, the approv al of a Governmental Authority necessary for the marketing and sale in a given cou ntry or regulatory jurisdiction, which may include the approval of an MAA ( but shall not include any Pricing Approv als ) . shall mean, with respect to each Batch Manufactur ed pursuant to this Agreement, that such Batch shall : ( a ) conform to th e applicable Specifications ; ( b ) be A-7 Execution Copy manufactured, packaged, labeled, handled, and store d in compliance with applicable Laws and the Qualit y Agreement ; ( c ) contain only Raw Materials that have been used, handled or stored in accordance with th e Storage Guidelines, applicable Laws and the Quality Agreeme nt ; and ( d ) not be adulterated or misbranded within the meaning of the FD&C Act, or within the meaning of a ny applicable state or municipal law in which the d efinitions of adulteration or misbranding are substantially th e same as those contained in the FD&C Act, as such Act and such law are constituted and effective at the time of delivery and will not be an article which may no t, under provisions of Sections 404, 505 or 512 of the FD&C Act, be introduced in interstate commerce