definiens: means any : [ Stockout, ] * [ recall in, or voluntary or temporary withdrawal from, the Territory ( iii ) [ black box warning for the Product in the Territory, ] * ( iv ) [ reduction of ( A ) the Average Selling Price of Doribax in the Territory that is greater than or equal to twenty percent ( 20 % ) of the Average Selling Price of Doribax as of the date on which the Average Selling Price of Do rib ax in the Territory first becomes publicly available, or ( B ) prior to the date on which the Average Selling Price of Doribax in the Territory first becomes publicly available, the published list price ( i.e., wholesale acquisition cost ) of Doribax in the Territory that is greater than or equal to twenty percent ( 20 % ) of the published list price ( i.e., wholesale acquisition cost ) of Doriba, x in the Territory as ofthe Effective Date, ] * ( v ) [ change by [COMPANY] of the Wholesale Acquisition Cost, ] * ( vi ) [ first commercial sale in the Territory of an Other Meropenem Product, ] * ( vii ) [ first commercial sale in the Territory of any Competing Product ( other than an Other Meropenem Product ) that is not sold in the Territory as of the Effective Date ( including the first commercial sale of any reformulation or relaunch of any Competing Product ), ] * 18 ' Confidential Treatment Requested . Omitted portions filed separately with the Commission . Execution Copy ( viii ) [ ( A ) stockout ( where stockout for purposes ofthis clause shall have a meaning analogous to Stockout ), or ( B ) withdrawal in the Territory, in each case, with respect to Doribax or Primaxin, ] * ( each ofthe foregoing significant market events set out in subsections ( i ) through ( viii ), a ), ( ix ) [ material adverse labeling change for the Product ( excluding a black box waming which is a Type I SME set out above in subsection ( iii » in the Territory, ] * ( x ) [ dissemination by [COMPANY] or any of its Affiliates of any data or information relating to the safety or efficacy of the Product that is reasonably likely to materially reduce the Gross Sales ( including as a result of any Adverse Events ), ] * ( xi ) [ material breach by [COMPANY] of its obligations under this Agreement that is reasonably likely to materially reduce Gross Sales, ] * ( xii ) [ imposition of govemrnental, including federal or state, price controls that is reasonably likely to materially reduce Gross Sales, ] * ( xiii ) [ occurrence of a force majeure event that adversely effects a party 's performance of its obligations hereunder for more than ten ( 10 ) business days and is reasonably likely to materially reduce Gross Sales, ] * ( xiv ) [ material adverse labeling change ( including any black box waming ) in the Territory with respect to Doribax or Primaxin, ] * ( xv ) [ material positive labeling change ( e.g., a new indication ) for the Product in the Territory, or ] * ( xvi ) [ change in Applicable Law that is reasonably likely to materially reduce Gross Sales, ] * ( each of the foregoing significant market events set out in subsections(ix ) through ( xvi ), a ) . For purposes of this definition the phrase [ includes a reduction of Gross Sales that would reasonably be likely to cause a decrease in the Stepped Amount for the Calendar Year ] *