This excerpt taken from the CERS 10-Q filed Oct 30, 2008.
We have limited experience in marketing and sales, or in managing a commercial operation. We have limited experience in managing regulatory affairs, particularly with foreign authorities.
Following our agreements with Baxter in February 2006, we became fully responsible for sales, marketing and distribution support of the INTERCEPT Blood System worldwide, except in those Asian territories covered by our agreements with BioOne for the platelet and plasma systems. As a consequence, we no longer rely upon Baxter or Fenwal for sales, marketing, distribution, or regulatory support of the INTERCEPT Blood System. In some cases, we will need to transition regulatory approvals obtained by Baxter to approvals issued in our name, based upon new or updated data we may be required to submit. If we fail in our efforts to develop such internal competencies or establish acceptable relationships with third parties on a timely basis, our attempts to commercialize the INTERCEPT Blood System may be irreparably harmed.