NEITHER
SPONSORS NOR MAINTAINS NOR HAS ANY LIABILITY FOR (A) ANY OF THE PLANS OR (B) ANY
OTHER EMPLOYEE BENEFIT PLANS OR ARRANGEMENTS.
(XIII)
ALL CONTRIBUTIONS, PREMIUMS OR PAYMENTS UNDER OR WITH RESPECT TO
EACH PLAN WHICH ARE OR WERE DUE ON OR BEFORE THE DATE HEREOF HAVE BEEN PAID.
(q)
Compliance with Laws; Licenses.
(I)
IBIS, THE BUSINESS AND, WITH RESPECT TO THE BUSINESS, ISIS ARE
NOT IN MATERIAL VIOLATION OF ANY LAW.
IBIS, THE BUSINESS, AND, WITH RESPECT TO
THE BUSINESS, ISIS AND IBIS' AND ISIS' REPRESENTATIVES HAVE COMPLIED WITH, AND
ARE IN MATERIAL COMPLIANCE WITH, ALL APPLICABLE LAWS, INCLUDING, WITHOUT
LIMITATION, THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, AS AMENDED AND REGULATIONS
PROMULGATED THEREUNDER, AND ALL U.S. FOOD AND DRUG ADMINISTRATION ("FDA") OR ITS
FOREIGN EQUIVALENT REGULATIONS GOVERNING, AMONG OTHER THINGS, THE PROTECTION OF
HUMAN SUBJECTS AND REGULATIONS GOVERNING CLINICAL INVESTIGATORS.
EXCEPT SUCH AS
MUST BE MADE AFTER THE FINANCING CLOSING (OR, WITH RESPECT TO THE ADDITIONAL
SHARES, THE SUBSEQUENT CLOSING), WHICH WILL BE FILED IN A TIMELY MANNER, NO
GOVERNMENTAL ORDERS, PERMISSIONS, CONSENTS, APPROVALS OR AUTHORIZATIONS ARE
REQUIRED TO BE OBTAINED AND NO REGISTRATIONS OR DECLARATIONS ARE REQUIRED TO BE
FILED IN CONNECTION WITH THE EXECUTION AND DELIVERY OF THE INVESTMENT DOCUMENTS,
THE ISSUANCE OF THE SHARES OR, IF ISSUED ON THE DATE HEREOF, THE ADDITIONAL
SHARES OR, EXCEPT AS CONTEMPLATED BY THE ACQUISITION AGREEMENT, THE TRANSFER OF
THE REMAINING SHARES.
(II)
IBIS HOLDS ALL LICENSES NECESSARY FOR THE OPERATION OR CONDUCT OF
THE BUSINESS (INCLUDING PURSUANT TO ENVIRONMENTAL LAWS).
SCHEDULE
3.1(Q)(II) SETS FORTH A LIST OF ALL LICENSES MATERIAL TO THE BUSINESS (THE
"MATERIAL LICENSES").
IBIS IS AND HAS BEEN IN COMPLIANCE WITH ALL TERMS AND
CONDITIONS OF SUCH MATERIAL LICENSES AND ALL MATERIAL LICENSES MAY BE RELIED
UPON BY IBIS FOR THE LAWFUL OPERATION OF THE BUSINESS AS CONDUCTED ON AND PRIOR
TO THE DATE HEREOF AND IMMEDIATELY FOLLOWING THE FINANCING CLOSING.
EACH
MATERIAL LICENSE IS VALID, BINDING AND IN FULL FORCE AND EFFECT AND IBIS AND THE
BUSINESS HAVE COMPLIED IN ALL MATERIAL RESPECTS WITH ALL REQUIREMENTS OF AND ARE
NOT IN DEFAULT UNDER ANY MATERIAL LICENSE AND HAVE NOT RECEIVED WRITTEN OR, TO
ISIS' OR IBIS' KNOWLEDGE, ORAL NOTICE THAT THE BUSINESS OR IBIS IS IN VIOLATION
OF ANY OF THE TERMS OR CONDITIONS OF SUCH MATERIAL LICENSE.
NO LOSS OR
SUSPENSION OF ANY LICENSE NOR ANY
23
PROCEEDING OR INVESTIGATION WHICH IS SEEKING SUCH A LOSS OR SUSPENSION IS
PENDING OR, TO ISIS' OR IBIS' KNOWLEDGE, THREATENED.
NEITHER IBIS NOR ISIS IS
OPERATING UNDER ANY WRITTEN OR ORAL FORMAL OR INFORMAL AGREEMENT OR
UNDERSTANDING WITH ANY LICENSING AUTHORITY, REGULATORY AUTHORITY OR ANY OTHER
GOVERNMENTAL AUTHORITY WHICH RESTRICTS THE CONDUCT OF THE BUSINESS OR REQUIRES
IBIS OR, WITH RESPECT TO THE BUSINESS, ISIS, TO TAKE OR REFRAIN FROM TAKING ANY
ACTIONS.
(r)
Environment, Health and Safety.
Ibis and the Business have at all times
materially complied with and are in material compliance with all Environmental
Laws, including, without limitation, all Licenses