definiens: ), or within the meaning of any state or municipal laws applicable to the Products and containing terms with substantially similar meanings as the meanings of adulteration or misbranding under the Act ; provided, however, that this provision shall not apply to, and NeraPharrn shall have no responsibility for, misbranding caused directly by [COMPANY] as a result of labels or package text specified by [COMPANY] for the Product ; 5.1.5 Timing . All Product supplied to [COMPANY] hereunder shall have been manufactured within twenty - two ( 22 ) weeks prior to receipt by [COMPANY] ; 5.1.6 Notification . NeraPharm will provide written notice to [COMPANY] of any proposed alterations to the Facility or to any Product manufacturing or testing process ; provided, however, that under no circumstances shall any such alteration be made without [COMPANY] ' express prior written consent, or before regulatory approval, if required for any suchalteration, is received in each country in which Product is then being sold ; and 5.1.7 No Encumbrance . TItle to all Product supplied to [COMPANY] hereunder shall pass to [COMPANY] as provided herein free and clear of any security interest, lien, or other encumbrance