definiens: within the meaning of the provisions of the Private Securities Litigation Reform Act of 1995 . You should be aware that ouractual results could differ materially from those contained in the forward - looking statements, which are based on management ’s currentexpectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercializeour product candidates ; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our productcandidates ; uncertainties or differences in interpretation in clinical trial results ; our inability to maintain or enter into, and the risks resultingfrom our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products ; competitive factors ; our inability to protect our patents or proprietary rights and obtainnecessary rights to third party patents and intellectual property to operate our business ; our inability to operate our business withoutinfringing the patents and proprietary rights of others ; general economic conditions ; the failure of any products to gain market acceptance;our inability to obtain anyA request for confidential treatment has been made with respect to portions of the following document that are marked with[*CONFIDENTIAL * ] . The redacted portions have been filed separately with the SEC