definiens: means the occur rence of any of the following, to the extent not caused by any act or omission on the part of, and o utside the reasonable control of, Orion, its Affiliates or Marketing Distributors : ( a ) any materially adverse change ( equivalent to an FDA - mandated addition of a warning ) mandated by Regulatory Authori ties in any of the Major European Countries on the product labelling of Lice nsed Product for the Initial Indication that is unique to such product among the class of LHRH agonists for the Initial Indication ; ( b ) any recall or withdrawal of Licensed Product fo r the Initial Indication mandated by Regulatory Authorities in any of the Major European Countries ; ( c ) the receipt by Orion of a written Claim asserti ng a product liability Claim or that the manufacture, use, sale, offer for sale or impor tation of Licensed Product for the Initial Indication in any country of the Territory infringes a Third Party Patent relating to the Bulk Drug Product and/or Insertion Tools or the man ufacture thereof or a Third Party trademark, as a result of which Or ion withdraws Licensed Product from the market in any of the countries in the Terr itory within sixty ( 60 ) days from receipt of such Claim ; or a determination by a cour t of competent jurisdiction in an unappealed or unappealable decision that a patent o r other intellectual property right owned by a Third Party is infringed by the ma nufacture, use, sale, offer for sale or importation of Licensed Product for the Ini tial Indication in the Territory, and enjoining such manufacture, use, sale, offer fo r sale, or importation ; ( d ) either ( i ) any significant ( at least [ * * * ] delay in obtaining Regulatory Approval of Licensed Product for the Initial Indication in any of the Major European Countries that is not caused by an act of or failure to act b y Orion, or ( ii ) an [COMPANY] decision, in accordance with Section 3.1.2(b ), that a Registr ation Study not be conducted, which decision would result in the inability to obt ain Regulatory Approval of Licensed Product for the Initial Indication in any of the Major European Countries ; * * * CONFIDENTIAL TREATMENT REQUESTED 8 ( e ) in any Calendar Year, LHRH analogs for the Init ial Indication have a combined market size ( in euros ) in the Major European Countr ies of [ * * * ] or less of their combined market size ( in euros ) for the immediately preceding Calendar Year ; and ( f ) failure of [COMPANY] to supply [ * * * ] in any Calendar Year at least [ * * * ] of the quantities of Batches of Bulk Drug Product and/or I nsertion Tools included in the Firm Commitment portion of the Initial Forecast or Rolling Forecast, as applicable, which failure to s upply is uncured for at least [ * * * ]