definiens: ) ; Whereas, Manufacturer and [COMPANY] wish to define their respective responsibilities as to the quality aspects of manufacturing and release of Product ( s ) to ensure compliance with the approved Finished Products applications andlor [COMPANY] requirements and/or any other regulatory demands, In connection with such responsibilities . this Quality Agreement sets forth a listing of activities associated with manufacture, supply, analysis, release and distribution of Produet(s ), Unless otherwise indicated . responsibility for each activity is assigned to either [COMPANY] . Manufacturer . or is assigned to both Manufacturer and Maeroeure, as indicated in the listing, NOW, THEREFORE, in consideration of the Parties ' agreement to perform the activities provided in this Quality Agreement and for other valuable consideration the receipt und sufficiency of which is hereby acknowledged . and intending to be legally bound . Manufacturer and [COMPANY] agree as provided in this Quality Agreement as follows : I, Effective Date The Effective Date of this Quality Agrecmcnt shall be the dutc written abovc . provided that this Quality Agreement has bcen duly executed by both Parties, Page 18 of 40 ConfidentiClI Treatrnent Requ8stpd 2 . Scope This Quality Agreement outlines the respective responsibilities of Manufaeturer and Macroeure with respect to the quality assurance of the Product(s ) manufactured and/or supplied by Manufacturer for Macroeure ( as specified in the preamble )