(A), (B) AND (C) ABOVE ARE MET, THEN, THE
MILESTONE PAYMENT SHALL BE REDUCED BY AN AMOUNT EQUAL TO 50% OF TMC'S COSTS OF
PERFORMING SUCH ADDITIONAL CLINICAL TRIALS(S). FOR PURPOSES OF THIS SECTION 8.3,
"CLINICAL TRIAL" MEANS, IN ACCORDANCE WITH EUROPEAN UNION DIRECTIVES, AN
INVESTIGATION, IN ACCORDANCE WITH A PROTOCOL APPROVED BY THE APPROPRIATE
AUTHORITIES, IN HUMAN SUBJECTS INTENDED TO DISCOVER OR VERIFY THE CLINICAL,
PHARMACOLOGICAL AND/OR OTHER PHARMACODYNAMICS EFFECTS OF AN INVESTIGATIONAL
PRODUCT(S), AND/OR TO IDENTIFY ANY ADVERSE REACTIONS TO AN INVESTIGATIONAL
PRODUCT(S), AND/OR TO STUDY ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION
OF AN INVESTIGATIONAL PRODUCT(S) WITH THE OBJECTIVE OF ASCERTAINING ITS SAFETY
AND/OR EFFICACY.
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For purposes of this Section 8, description of a payment as non-refundable or
non-creditable shall not be interpreted to negate the right of the paying party
to offset amounts due to it hereunder from the payee party against such payment.
8.4.
OUT-OF-POCKET COSTS.
8.4.1.
EACH PARTY SHALL BE RESPONSIBLE FOR ITS OWN EXPENSES OF PERFORMING
UNDER THIS AGREEMENT. NOTWITHSTANDING THE FOREGOING, TMC SHALL BE RESPONSIBLE
FOR ANY OUT-OF-POCKET COSTS OWED TO A THIRD PARTY AND INCURRED BY NYCOMED AFTER
THE EFFECTIVE DATE TO THE EXTENT SOLELY ATTRIBUTABLE AND DIRECTLY RELATED TO:
(A) NYCOMED'S TRANSFER OF APPROVALS AND REGULATORY FILINGS TO TMC OR TMC'S
DESIGNEE PURSUANT TO SECTION 6.4, (B) NYCOMED'S MAINTENANCE OF APPROVALS
PURSUANT TO SECTION 6.5, (C) NYCOMED'S REGISTRATION EFFORTS WITH RESPECT TO
REGULATORY FILINGS PURSUANT TO SECTION 6.5, (D) NYCOMED'S WITHDRAWAL OR
AMENDMENT OF REGULATORY FILINGS PURSUANT TO SECTION 6.5 OR 6.9.2, (E) NYCOMED'S
TERMINATION OR AMENDMENT OF APPROVALS PURSUANT TO SECTION 6.9, (F) NYCOMED'S
TRANSFER OF THE ASSIGNED TRADEMARK REGISTRATIONS TO TMC OR TMC'S DESIGNEE
PURSUANT TO SECTION 5.1, (G) NYCOMED'S MAINTENANCE OF THE ASSIGNED TRADEMARK
REGISTRATIONS PRIOR TO SUCH TRANSFER AND (H) NYCOMED'S TRANSFER OF THE ASSIGNED
DOMAIN NAMES TO TMC OR TMC'S DESIGNEE PURSUANT TO SECTION 5.2 (THE
"OUT-OF-POCKET COSTS"); PROVIDED, HOWEVER, THAT SUCH OUT-OF-POCKET COSTS SHALL
BE INCURRED IN THE ORDINARY COURSE OF BUSINESS AND CONSISTENT WITH NYCOMED'S
PAST PRACTICE AND SHALL BE SUBSTANTIALLY IN ACCORDANCE WITH THE BUDGET SET FORTH
AS SCHEDULE 8.4.1 (AS THE SAME MAY BE AMENDED FROM TIME TO TIME WITH THE PRIOR
WRITTEN APPROVAL OF TMC, WHICH APPROVAL WILL NOT BE UNREASONABLY WITHHELD); AND
PROVIDED, FURTHER, THAT NYCOMED SHALL MAINTAIN ADEQUATE SUPPORTING DOCUMENTATION
TO SUBSTANTIATE ALL OUT-OF-POCKET COSTS BILLED TO TMC AND SHALL PROVIDE THE
FOREGOING TO TMC UPON REQUEST.
8.4.2.
TAXES NOW OR HEREAFTER IMPOSED WITH RESPECT TO TMC'S REIMBURSEMENT
OF THE OUT-OF-POCKET COSTS CONTEMPLATED HEREUNDER (WITH THE EXCEPTION OF INCOME
TAXES OR OTHER TAXES IMPOSED UPON NYCOMED AND MEASURED BY THE GROSS OR NET
INCOME OF NYCOMED) SHALL BE THE RESPONSIBILITY OF TMC AS BETWEEN TMC AND NYCOMED
DANMARK APS, AND IF PAID OR REQUIRED TO BE PAID BY NYCOMED DANMARK APS, THE
AMOUNT THEREOF SHALL BE ADDED TO AND BECOME A PART OF THE AMOUNTS PAYABLE BY TMC
HEREUNDER. NYCOMED DANMARK APS REMAINS RESPONSIBLE HOWEVER TO THE LOCAL VAT
AUTHORITIES FOR INTRODUCING ANY PERIODICAL VAT RETURNS AND PAYING