definiens: shall mean that one or more of the following events or circumstances has occurred indevelopment, manufacturing or regulatory conditions relating to a Licensed Calcitonin Product that delays the furtherdevelopment of such Licensed Calcitonin Product or results in delayed achievement of the applicable event ; provided that(i ) such events or circumstances were not caused by the negligent, intentional or fraudulent act or omission of Tarsa or any ofits Affiliates or Sublicensees and ( ii ) Tarsa or its Affiliates or Sublicensees have taken all Commercially Reasonable Efforts toovercome such events or circumstances : ( A ) * * *, if prepared and submitted in accordance with all applicable laws, rules andregulations, * * * outside the United States ; ( B ) * * * a Licensed Calcitonin Product * * *, or by or on behalf of Tarsa or itsAffiliates or Sublicensees reasonably based on * * *, or by Tarsa ’s reasonable * * * Licensed Calcitonin Product ; ( C ) * * *, asspecified in the applicable * * * for the Licensed Calcitonin Product ; ( D ) receipt of * * * Licensed Calcitonin Product;(E ) decisions, communications * * * the Licensed Calcitonin Product that * * *, including * * * the Licensed Calcitonin Product * * * ; ( F ) * * * the Licensed Calcitonin Product, including * * * or any failure by Unigene with respect to its supply obligationshereunder ; ( G ) any material breach by Unigene of its obligations under this Agreement ; ( H ) changes in applicable lawsrelating to the development or manufacture of a Licensed Calcitonin Product which materially and adversely affect Tarsa ’s orits Affiliates ’ or Sublicensees ’ ability to develop or manufacture the Licensed Calcitonin Product in accordance with theDevelopment Timeline, or ( I ) other external factors not in the reasonable control of Tarsa or its Affiliates or Sublicensees