definiens: as such term is defined in Section 7.5(a ) of the Original PurchaseAgreement ( the ), which may only be revoked pursuant to the next sentence . In the event that NPS or any of its Affiliatesfails to submit a Marketing Authorization Application ( that NPS reasonably expects to be validated and accepted for review ) to theEuropean Medicines Agency for the Product in the European Union by [ * * * ] ( the ), DR3 may revoke theConsent by providing written notice to NPS of such revocation on or before [ * * * ] ( a ) . In connection with theRegulatory Milestone, NPS currently intends to pursue approval of the Product for hypo - parathyroidism and may amend, modify orwithdraw any pre - existing regulatory filings or marketing approvals for the Product . In the event of a Revocation, this Agreement shallbe of no further force or effect and the Original Purchase Agreement shall become active . In such event, as of the date DR3 deliversa Revocation to NPS, at DR3 's election either ( i ) the twelve ( 12 ) month period referenced in Section 7.5(a ) of the Original PurchaseAgreement shall commence, or ( ii ) the provisions of Section 7.5(c ) of the Original Purchase Agreement shall commence as thoughsuch twelve ( 12 ) month period had already expired . In the event ( i ) that NPS achieves the Regulatory Milestone or ( ii ) that NPSdoesn't achieve the Regulatory Milestone and DR3 fails to exercise the Revocation by [ * * * ], the Consent shall be irrevocable