definiens: means ( A ) all decisions made by the CRC, JSC and JPTs that, in the reasonableopinion of either Party, are likely to have any of the following impacts : ( i ) [ * ] under a DevelopmentPlan or Brand Plan ; ( ii ) a change to a Development Plan or Brand Plan that results in the lesser of(a ) an increase of [ * ] or more ( provided, that such amount is at least [ * ] ) and ( b ) [ * ] or more, in eachcase, to the then - current budgeted amount of Development Costs and/or General Costs for anyspecific calendar year under the applicable Development Budget, Operations Budget orCommercialization Budget or the amounts estimated under Sections 7.2.1 ( Partner Costs ) and 7.2.2(Amgen Costs ) ; ( iii ) a change to a Development Plan or Brand Plan that results in a decrease of [ * ] ( provided, that such amount is at least [ * ] ) or more to the then - current budgeted amount ofDevelopment Costs and/or General Costs for any specific calendar year under the applicableDevelopment Budget, Operations Budget or Commercialization Budget or the amounts estimatedunder Sections 7.2.1 ( Partner Costs ) and 7.2.2 ( [COMPANY] Costs ) ; or ( iv ) a change to a DevelopmentPlan ( including any plans with respect to a contemplated Regulatory Approval set forth therein ) orBrand Plan that would, based upon [ * ], result in [ * ] of a Product for any specific calendar year underthe applicable Development Plan or Brand Plan ; ( B ) agreement of the initial CommercializationBudget for each Product ; ( C ) agreement of the initial Brand Plan ( or material updates theretoreflecting the launch of a new indication ), Global Payer Plan and any Access and Pricing Plan foreach Product ; and ( D ) deadlocks with respect to the approval of an annual Development Budget, Operations Budget or Commercialization Budget as provided for under Section 7.7 ( BudgetDeadlocks )