definiens: means any ( a ) Validation Criteria Dispute, ( b ) dispute between the Parties ( or their respectiveIntellectual Property counsel ) related to whether the Intellectual Property of a Third Party is required for the Development, Manufacture orCommercialization of a Cost - Share Product that is a [COMPANY] Contributed Collaboration Product, ( c ) dispute as to whether a Pre - INDMilestone Event or Early Clinical Development Milestone Event has been achieved, and ( d ) dispute as to whether ( x ) the Initial OperationalDevelopment Plan for an Opt - Out Product, including any alternate version, or any updated version thereof is materially inconsistent with theInitial Long - Term Development Plan for such Opt - Out Product provided by Decibel to [COMPANY] pursuant to Section 7.1(a)(i ), triggeringRegeneron ’s right to convert such Opt - Out Product to a Cost - Share Product pursuant to Section 9.3(a)(iii ) or ( y ) the Post - POC OperationalDevelopment Plan for a Post - POC Opt - Out Product or any updated version thereof is materially inconsistent with the Post - POC Long - TermDevelopment Plan for such Post - POC Opt - Out Product provided by Decibel to [COMPANY] pursuant to Section 7.2(a)(i ), including anyalternate version, triggering [COMPANY] ’s right to convert such Post - POC Opt - Out Product into a Cost - Share Product pursuant toSection 9.3(b)(iv )