NOTIFY THE OTHER PARTY WITHIN
FORTY-EIGHT (48) HOURS AFTER IT FORMS SUCH BELIEF. BEFORE TAKING ANY ACTION WITH
RESPECT TO A RECALL OR MARKET WITHDRAWAL, TO THE EXTENT POSSIBLE, MGI, ITS
AFFILIATES, AND LICENSEES SHALL PROVIDE SUPERGEN WITH A REASONABLE OPPORTUNITY
TO REVIEW, COMMENT ON AND CONSULT WITH RESPECT TO SUCH RECALL OR MARKET
WITHDRAWAL, AND MGI, ITS AFFILIATES, AND LICENSEES SHALL CONSIDER IN GOOD FAITH
ANY COMMENTS OR SUGGESTIONS OF SUPERGEN. AS BETWEEN THE PARTIES, MGI SHALL BE
SOLELY RESPONSIBLE FOR ALL RECALLS AND MARKET WITHDRAWALS, PROVIDED THAT MGI
SHALL KEEP SUPERGEN FULLY INFORMED WITH RESPECT THERETO AND SHALL PROVIDE
SUPERGEN WITH REASONABLE OPPORTUNITIES TO COMMENT WITH RESPECT TO THE ACTIVITIES
ASSOCIATED THEREWITH. AS BETWEEN THE PARTIES, ALL RECALLS AND MARKET WITHDRAWALS
SHALL BE AT THE SOLE COST AND EXPENSE OF MGI.
7.8
DILIGENCE MILESTONES.
7.8.1
THE COMMERCIALIZATION PLAN SHALL INCLUDE THE
DEVELOPMENT AND COMMERCIALIZATION MILESTONES AND DATES FOR COMPLETION THEREOF
(EACH A "COMPLETION DATE") THAT ARE DESCRIBED IN AND OTHERWISE ESTABLISHED IN
ACCORDANCE WITH THIS SECTION 7.8 (SUCH MILESTONES AND COMPLETION DATES,
COLLECTIVELY
THE "DILIGENCE MILESTONES"). EXHIBIT 7.8 SETS FORTH THE DILIGENCE
MILESTONES FOR MDS AND AML. IN ADDITION TO SUCH DILIGENCE MILESTONES, WITH
RESPECT TO EACH LICENSED PRODUCT FOR WHICH A MARKETING AUTHORIZATION IS OBTAINED
IN A MAJOR COUNTRY, THERE SHALL BE AN ADDITIONAL DILIGENCE MILESTONE THAT MGI
ACHIEVE FIRST COMMERCIAL SALE OF THE LICENSED PRODUCT IN THE MAJOR COUNTRY NO
LATER THAN NINETY (90) DAYS AFTER THE MARKETING AUTHORIZATION IS OBTAINED (OR IF
LATER AND REQUIRED IN THE MAJOR COUNTRY, AFTER APPROVAL OF PRICING AND/OR
REIMBURSEMENT IS OBTAINED FOR SALES OF THE LICENSED PRODUCT) (A "LAUNCH
MILESTONE"). IF MGI FAILS TO ACHIEVE SUCH A LAUNCH MILESTONE BY THE NINETY (90)
DAY PERIOD FOLLOWING RECEIPT OF MARKETING AUTHORIZATION AS SET FORTH IN
23
the sentence above, and if a milestone payment is specified in Section 3.1 for
the related Diligence Milestone and has not previously been paid, then MGI shall
pay to SuperGen within thirty (30) days after such failure the milestone payment
set forth in Section 3.1 for the missed Launch Milestone and shall continue to
use Diligent Efforts to meet the other milestones set forth in Section 3.1.
7.8.2
THE PARTIES AGREE THAT, WITHOUT LIMITING ANY OTHER
RIGHT OR REMEDY OF SUPERGEN HEREUNDER SUPERGEN SHALL HAVE THE RIGHT TO TERMINATE
THIS AGREEMENT IN ITS ENTIRETY (IN THE SAME MANNER AS IF MGI HAD MATERIALLY
BREACHED THIS AGREEMENT) PURSUANT TO SECTION 14.3 IF MGI HAS NOT ACHIEVED FIRST
COMMERCIAL SALE OF A LICENSED PRODUCT IN A MAJOR COUNTRY BY DECEMBER 31, 2008;
PROVIDED, HOWEVER, THAT
SUPERGEN'S RIGHT TO TERMINATE PURSUANT TO THIS
SECTION 7.8.2 ABOVE, SHALL BE TOLLED SO LONG AS AT LEAST ONE PHASE III TRIAL, OR
EQUIVALENT, FOR A LICENSED PRODUCT FOR A MAJOR COUNTRY (A "REGISTRATION TRIAL")
IS ONGOING ON DECEMBER 31, 2008, AND MGI IS USING, AND CONTINUES TO USE,
DILIGENT EFFORTS TO COMPLETE SUCH REGISTRATION TRIAL(S) SUCCESSFULLY AND OBTAIN
A MARKETING AUTHORIZATION BASED UPON SUCH REGISTRATION TRIAL(S). SUPERGEN'S
RIGHT TO