definiens: means, with respect to any Product ( a ) raw matcrial specifi ations(including chemical, microbiology and packag, ing specifications ), ( b ) sampling requiremcnt'(i.e ., lab, chemical and microbiology ), ( c ) compounding module, including compounding processand major equipment, ( d ) intennediate specificntions, ( c ) packaging module ( includingpackaging proccdures, torque and fill wcights ) . and ( I ) finishe.d Product pecifications releasecriteria inclnding RTU 's Acceptable Qn, lity Limits . Specificalion shall be established by SMRor amended from tim to time through the collaboration of SMR and RTU through the writlenagreement of the panies by way of a written Product or Process Change Request ( ) inaccordance with Section _ means, he following agreements : Unoproslone NDA Trailfef, Patell1 and Know - how Lieen ing, and Dala Sharing Agreement dated April 23, 2009,Unoprostone Exch.sive Manufacturing Illld Supply Agreement dated April 23, 2009, andTechnology Assignment and License Agreemcnt dated February 2009