SR NonConforming LOT

SR NonConforming LOT. Means a LOT of Product that fails to conform to the Specifications and such non-conformance results from SR's Material Failure to Manufacture the Product in compliance with (a) GMP or (b) the Manufacturing Protocol. For the purposes of this definition, "Material Failure" means any failure by SR in the manufacturing the Product as a result of material failure to comply with Manufacturing Protocol and objectively concluded as having a serious impact on quality of the Product. The determination of... whether or not there has been a Material Failure shall be determined in good faith by the Parties taking into consideration the nature of the Product and/or Primary Raw Material, the completeness of the Manufacturing Protocol (including the historical success rate of the Manufacturing Protocol) and any other element reasonably necessary to be considered. View More