definiens: shall mean a defect or sHbstaace ia API which is preseRt or inlierent ia l'\PI and which is subseqHently shown also to be present or inliereat ia the mHmally agreed sample ofA .... DI that each Party shall retaia a part of as a standard or refereace material ( the ), aotwithstaHdiag that sHch defect or substaace may ROt be or may ROt have beea readily discoverable at the time sHch sample was retruaed . The Refereace Sam : ple shall be periodically replaced as required and agreed Hpon by the Parties ha'liag regard to Shelf Life of the API therein . Additionally, each time that any chaage to the Specifioatioas, manafaotl : l : Fing process or SOHrce of R9:\'l Materials is effected following appfOyal by Geata pHfsaaRt to the terms of Articles 3 and 4 hereof, a further sample of API shall be agreed upon and retained by the Parties so as to become the Refereace Sample ' Nith effect from the iatroduction of SHch change . For clarificatioa, those sectioas of the Quality Agreemeat headed aad shall not be coastrued as imposiag oa [COMPANY] obligations in respect of E~(cluded Ayecia Risks