Manual Test Kit

Manual Test Kit. A Kit for performing the Manual Test, as currently described on Exhibit B attached hereto. For purposes of clarification, the parties acknowledge that to the extent that Exhibit B states that the Manual Test is "For Research Use Only" and "Not for Use in Diagnostic Procedures", these statements will not apply after FDA Approval has been obtained. Upon FDA Approval of the Manual Test, Exhibit B will be replaced by the actual package insert at that time.