(the "Regulated
Products") required to be filed with or otherwise provided to the United States
Food and Drug Administration ("FDA") or any other federal, state, local, or
foreign governmental or regulatory body or authority (each, a "Governmental
Body") with jurisdiction over the testing, manufacture, use, marketing or sale
of the Regulated Products, has complied with all applicable requirements of the
FDA or other Governmental Body with respect to the Regulated Products, and all
regulatory licenses or approvals in respect thereof are in full force and
effect.
All documentation, correspondence, reports, data, analyses and
certifications relating to or regarding any medical devices of the Company,
filed or delivered by or on behalf of the Company to any Governmental Body was
true and accurate when so filed or delivered, and remains true and accurate in
all material respects.
Except as specifically contemplated by this Agreement,
the Warrants, the Registration Rights Agreement, the Company is not required to
obtain any consent, approval, authorization or order of, or make any filing or
registration with, any court or governmental agency or any regulatory or self
regulatory agency or other third party in order for it to execute, deliver or
perform any of its obligations under this Agreement, the Warrants or the
Registration Rights Agreement in accordance with the terms hereof or thereof.
(G)
SEC DOCUMENTS, FINANCIAL STATEMENTS.
SINCE JANUARY 1, 2001, THE
COMPANY HAS TIMELY FILED (WITHIN APPLICABLE EXTENSION PERIODS) EACH ANNUAL,
QUARTERLY, CURRENT AND OTHER REPORT, REGISTRATION STATEMENT, PROXY STATEMENT,
SCHEDULE, FORM, AND OTHER DOCUMENT REQUIRED TO BE FILED OR FURNISHED BY IT WITH
THE SEC PURSUANT TO THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED (THE
"EXCHANGE ACT") AND THE SECURITIES ACT (ALL OF THE FOREGOING FILED OR FURNISHED
PRIOR TO THE DATE HEREOF AND ALL EXHIBITS INCLUDED THEREIN AND FINANCIAL
STATEMENTS AND SCHEDULES THERETO AND DOCUMENTS INCORPORATED BY REFERENCE
THEREIN, BEING HEREINAFTER REFERRED TO HEREIN AS THE "SEC DOCUMENTS").
AS OF
THEIR RESPECTIVE DATES, THE SEC DOCUMENTS COMPLIED IN ALL MATERIAL RESPECTS WITH
THE REQUIREMENTS OF THE EXCHANGE ACT OR THE SECURITIES ACT, AS THE CASE MAY BE,
AND THE RULES AND REGULATIONS OF THE SEC PROMULGATED THEREUNDER APPLICABLE TO
THE SEC DOCUMENTS, AND NONE OF THE SEC DOCUMENTS, AT THE TIME THEY WERE FILED OR
FURNISHED WITH THE SEC, CONTAINED ANY UNTRUE STATEMENT OF A MATERIAL FACT OR
OMITTED TO STATE A MATERIAL FACT REQUIRED TO BE STATED THEREIN OR NECESSARY IN
ORDER TO MAKE THE STATEMENTS THEREIN, IN LIGHT OF THE CIRCUMSTANCES UNDER WHICH
THEY WERE MADE, NOT MISLEADING.
NONE OF THE STATEMENTS MADE IN ANY SUCH SEC
DOCUMENTS IS, OR HAS BEEN, REQUIRED TO BE AMENDED OR UPDATED UNDER APPLICABLE
LAW (EXCEPT FOR SUCH STATEMENTS AS HAVE BEEN AMENDED OR UPDATED IN SUBSEQUENT
FILINGS MADE PRIOR TO THE DATE HEREOF).
AS OF THEIR RESPECTIVE DATES, THE
FINANCIAL STATEMENTS OF THE COMPANY INCLUDED IN THE SEC DOCUMENTS COMPLIED IN
ALL MATERIAL RESPECTS WITH APPLICABLE ACCOUNTING REQUIREMENTS AND THE PUBLISHED
RULES AND REGULATIONS OF THE SEC APPLICABLE WITH RESPECT THERETO.
SUCH