definiens: Inability to Supply " shall mean : ( i ) with respect to the supply of API for Approved Studies, Contingent Approved Studies or Sole - Funded SFI Registrational Studies, the Company 's failure for any reason, including without limitation force majeure reasons or otherwise, to supply ERS with quantities of API meetingthe Specifications and Manufacturing Standards equal to at least [ * ] of the quantity of API required to conductsuch Approved Study, Contingent Approved Study or Sole - Funded SFI Registrational Study, as the case maybe, during the applicable time period ; and ( ii ) with respect to the supply of API for commercial sales, theCompany 's failure for any reason, including without limitation force majeure reasons or otherwise, to supplyERS with quantities of API meeting the Specifications and Manufacturing Standards equal to at least [ * ] of thequantity of API required for commercial sales during the applicable time period . "*Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities andExchange Commission