definiens: means ( a ) a clinical holdbeing placed on a Collaboration Product, a delay in response from a Regulatory Authority, or a material drugmanufacturing problem that would be reasonably expected to impede or significantly delay a product advancingthrough Development or Commercialization ; provided, that if a Good Reason is invoked by Decibel as a reason tocease Development or Commercialization, then Decibel shall use Commercially Reasonable Efforts to resolve theproblem(s ) that is the basis of such Good Reason as soon as is practicable, ( b ) any Third Party litigation with respectto the applicable Collaboration Product, ( c ) the failure of [COMPANY] or its Affiliate to ( i ) perform any RegeneronDesignated Activities necessary for the Development or Commercialization of the applicable Collaboration Productor ( ii ) fulfill its supply obligations under any applicable Supply Agreement to supply Decibel the Collaboration Productnecessary for the Development or Commercialization of the applicable Collaboration Product, or ( d ) a globalpandemic, provided that if Good Reason due to a global pandemic is invoked by Decibel with respect to Decibel’sfailure to use Diligent Efforts to complete any Decibel Designated Activity set forth the Otoferlin DevelopmentCandidate Plan or to complete the necessary manufacturing and GLP toxicology studies to support an IND or CTAwith respect to any Collaboration Product Directed to Otoferlin, then the burden shall be on Decibel to demonstratethat resource allocation in Decibel ’s other programs were reduced proportionally to help mitigate the effect of suchglobal pandemic . ” c