ON A COUNTRY-BY-COUNTRY
BASIS), AND BE FULLY RELEASED OF ANY OBLIGATIONS HEREUNDER (EXCEPT AS IS
EXPRESSLY PROVIDED FOR HEREIN) AS FOLLOWS:
(I)
UPON THIRTY (30) DAYS PRIOR WRITTEN
NOTICE AT ANY TIME IF SCHERING DETERMINES, IN ITS REASONABLE JUDGMENT, THAT
THERE ARE ISSUES OF SAFETY;
(II)
UPON THIRTY (30) DAYS PRIOR WRITTEN NOTICE
IF THE MANUFACTURING PROCESS FOR THE PRODUCT CANNOT BE SCALED TO ACHIEVE
CMC/MANUFACTURING WITHIN THE TIMELINES SET OUT IN THE CMC/MANUFACTURING PLAN AND
BUDGET, AS REVISED FROM TIME TO TIME BY THE STEERING COMMITTEE;.
(III)
IMMEDIATELY IF ANY THIRD PARTY RECEIVES AN
INJUNCTION (PRELIMINARY OR PERMANENT) RESTRICTING THE MANUFACTURE, USE OR SALE
OF THE PRODUCT IN ANY COUNTRY ON THE GROUNDS OF THIRD PARTY PATENT INFRINGEMENT
AND SUCH INJUNCTION CONTINUES IN FORCE FOR A PERIOD OF THREE (3) MONTHS OR
LONGER;
(IV)
UPON THIRTY (30) DAYS' WRITTEN NOTICE TO
SONUS, IF, BASED UPON ASSEMBLED NDA SUBMISSION DATA FROM, OR THE RESULTS OF, THE
PIVOTAL TRIAL, SCHERING DETERMINES, USING ITS REASONABLE JUDGMENT, THAT SUCH
RESULTS DO NOT SUPPORT THE SUBMISSION OF THE PRODUCT FOR NDA APPROVAL; OR
38
(V)
AT ANY TIME AFTER NDA APPROVAL, UPON TWELVE
(12) MONTHS' NOTICE TO SONUS, FOR ANY REASON, DURING WHICH TIME SCHERING SHALL
REMAIN RESPONSIBLE FOR ALL OF ITS DUTIES AND OBLIGATIONS HEREUNDER;
(B)
TERMINATION FOR MATERIAL BREACH.
FAILURE BY
SCHERING OR SONUS TO COMPLY WITH ANY OF THE RESPECTIVE MATERIAL OBLIGATIONS AND
CONDITIONS CONTAINED IN THIS AGREEMENT SHALL ENTITLE THE OTHER PARTY TO GIVE THE
PARTY IN DEFAULT NOTICE REQUIRING IT TO CURE SUCH DEFAULT.
IF SUCH DEFAULT IS
NOT CURED WITHIN NINETY (90) DAYS AFTER RECEIPT OF SUCH NOTICE, THE NOTIFYING
PARTY SHALL BE ENTITLED (WITHOUT PREJUDICE TO ANY OTHER RIGHTS CONFERRED ON IT
BY THIS AGREEMENT) TO TERMINATE THIS AGREEMENT OR, IN THE EVENT OF AN UNCURED
MATERIAL BREACH BY SONUS, EFFECT THE RIGHTS OF SCHERING SET FORTH IN
SECTION 16.03(C) BY GIVING A NOTICE TO TAKE EFFECT IMMEDIATELY.
NOTWITHSTANDING
THE FOREGOING, IN THE EVENT OF NON-MONETARY DEFAULT, IF THE DEFAULT IS NOT
REASONABLY CAPABLE OF BEING CURED WITHIN THE NINETY (90) DAY CURE PERIOD BY THE
DEFAULTING PARTY AND SUCH DEFAULTING PARTY IS MAKING A GOOD FAITH EFFORT TO CURE
SUCH DEFAULT, THE NOTIFYING PARTY MAY NOT TERMINATE THIS AGREEMENT, PROVIDED,
HOWEVER, THAT THE NOTIFYING PARTY MAY TERMINATE THIS AGREEMENT IF SUCH DEFAULT
IS NOT CURED WITHIN ONE HUNDRED EIGHTY (180) DAYS OF SUCH ORIGINAL NOTICE OF
DEFAULT.
THE RIGHT OF EITHER PARTY TO TERMINATE THIS AGREEMENT AS HEREINABOVE
PROVIDED SHALL NOT BE AFFECTED IN ANY WAY BY ITS WAIVER OF, OR FAILURE TO TAKE
ACTION WITH RESPECT TO ANY PREVIOUS DEFAULT.
(C)
TERMINATION FOR INSOLVENCY.
IN THE EVENT
THAT ONE OF THE PARTIES HERETO SHALL GO INTO LIQUIDATION, OR IF A RECEIVER OR
TRUSTEE BE APPOINTED FOR THE PROPERTY OR ESTATE OF THAT PARTY AND SAID RECEIVER
OR TRUSTEE IS NOT REMOVED WITHIN SIXTY (60) DAYS, OR THE PARTY MAKES AN
ASSIGNMENT FOR THE BENEFIT OF CREDITORS (COLLECTIVELY, A "BANKRUPTCY EVENT"),
AND WHETHER ANY OF