CAD APPLICATION USED IN THE R2
SHOWCASE (EXCLUSIVE OF HARDWARE COMPONENTS).
8.10 PAYMENTS.
VTAL SHALL MAKE ALL PAYMENTS DUE HEREUNDER WITHIN FORTY-FIVE
(45) DAYS OF THE DATE OF R2'S INVOICE.
ANY PAYMENTS THAT ARE NOT TIMELY PAID AS
PROVIDED HEREUNDER SHALL BEAR INTEREST AT AN ANNUAL RATE EQUAL TO ONE AND A HALF
PERCENT (1.5%) PER MONTH OR THE MAXIMUM AMOUNT PERMITTED BY LAW, WHICHEVER IS
LESS, CALCULATED FROM THE DATE THE PAYMENT WAS DUE UNTIL THE DATE THE PAYMENT IS
RECEIVED BY R2.
ANY FAILURE OF VTAL TO MAKE TIMELY PAYMENT TO R2 DUE HEREUNDER
WILL CONSTITUTE A MATERIAL BREACH OF THIS AGREEMENT AND VTAL'S PAYMENT OF SUCH
INTEREST ON LATE PAYMENTS WILL NOT PREVENT R2 FROM EXERCISING ANY OTHER RIGHTS
UNDER APPLICABLE LAW.
8.11 TAXES.
ALL PRICES SPECIFIED HEREUNDER DO NOT INCLUDE AND ARE NET OF ANY
FOREIGN OR DOMESTIC GOVERNMENTAL TAXES OR CHARGES OF ANY KIND THAT MAY BE
APPLICABLE TO THE SALE, LICENSING, MARKETING, OR DISTRIBUTION OF THE R2 PRODUCT,
INCLUDING WITHOUT LIMITATION EXCISE, SALES, USE, PROPERTY, LICENSE, VALUE-ADDED
TAXES, WITHHOLDING OR SIMILAR TAXES, CUSTOMS OR OTHER IMPORT DUTIES OR OTHER
TAXES, TARIFFS OR DUTIES, OTHER THAN TAXES WHICH ARE IMPOSED SOLELY ON THE NET
INCOME OF R2.
ANY SUCH TAXES WHICH ARE OTHERWISE IMPOSED ON PAYMENTS TO R2
SHALL BE THE SOLE RESPONSIBILITY OF VTAL.
9.
REPORTING AND CUSTOMER COMPLAINTS
9.1
MEDICAL DEVICE REPORTING.
PURSUANT TO GOVERNMENTAL MEDICAL DEVICE
REPORTING REGULATIONS (E.G. THE FDA'S MEDICAL DEVICE REPORTING (MDR)
REGULATIONS, THE EUROPEAN MEDICAL DEVICE VIGILANCE GUIDELINES, AND ANY OTHER
APPLICABLE MEDICAL DEVICE REPORTING REGULATIONS), THE PARTIES MAY BE REQUIRED TO
REPORT TO THE APPLICABLE AGENCY INFORMATION THAT REASONABLY SUGGESTS THAT THE
PRODUCTS CONTEMPLATED HEREUNDER MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATH OR
SERIOUS INJURY OR HAS MALFUNCTIONED AND THAT THE DEVICE WOULD BE LIKELY TO CAUSE
OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
R2
SHALL BE PRIMARILY RESPONSIBLE FOR EVALUATING ANY SUCH REPORTABLE INCIDENTS THAT
RELATE TO THE R2 PRODUCT, AND VTAL SHALL BE PRIMARILY RESPONSIBLE FOR EVALUATION
OF ANY REPORTABLE INCIDENTS THAT RELATE TO THE VTAL WORKSTATION. EACH OF R2 AND
VTAL AGREE TO SUPPLY TO THE OTHER ANY INFORMATION RELATING TO SUCH REPORTABLE
INCIDENT PROMPTLY AFTER BECOMING AWARE OF IT SO THAT EACH OF R2 AND VTAL CAN
COMPLY WITH GOVERNMENTAL REPORTING REQUIREMENTS.
9.2
CUSTOMER COMPLAINTS.
VTAL SHALL PROMPTLY INVESTIGATE, MONITOR, AND NOTIFY
R2 OF ALL CUSTOMER AND/OR REGULATORY COMPLAINTS CONCERNING THE USE OF THE R2
PRODUCT, OR THE VTAL WORKSTATION (REGARDLESS OF WHETHER SUCH VTAL WORKSTATION IS
EQUIPPED WITH THE R2 PRODUCT) IN THE TERRITORY.
R2 SHALL PROMPTLY INVESTIGATE,
MONITOR AND NOTIFY VTAL OF ALL CUSTOMER AND/OR REGULATORY COMPLAINTS CONCERNING
THE USE OF THE R2 SHOWCASE.
EACH PARTY SHALL ADVISE THE OTHER OF ALL SUCH
COMPLAINTS ALLEGING PATIENT INJURY WITHIN TWENTY FOUR (24) HOURS, AND OF ALL
OTHER MATERIAL COMPLAINTS AS PROMPTLY AS POSSIBLE BUT NOT MORE THAN FIVE (5)
BUSINESS DAYS FOLLOWING THE DATE A PARTY RECEIVES SUCH COMPLAINT.
IN ADDITION,
WITHIN FIFTEEN (15)