UNDERSTANDING THE NDA IN THE U.S. AND THE MAA IN
EUROPE, INCLUDING THE DEVELOPMENT THAT HAS BEEN CONDUCTED, AND THE ASSOCIATED
REGULATORY DOCUMENTATION AND SUPPORTING DATA, ANALYZING THE SUPPORTING DATA,
REVIEWING AND EDITING THE REGULATORY DOCUMENTATION, OFFERING STRATEGIC INPUT,
PARTICIPATING IN ALL INTERACTIONS WITH FDA AND EMEA, HELPING TO PREPARE ANSWERS
TO FDA AND EMEA CORRESPONDENCE AND INQUIRIES, SUBJECT TO SECTION 5.2.1.
17
5.3
MGI DEVELOPMENT.
5.3.1
EXCEPT AS OTHERWISE SET FORTH IN SECTION 5.2.1, MGI
SHALL ASSUME AND BE LEGALLY RESPONSIBLE, AND AGREES, TO USE DILIGENT EFFORTS TO
PERFORM ALL FURTHER DEVELOPMENT OF THE LICENSED PRODUCTS AND OBTAIN SUCH
REGULATORY APPROVALS, INCLUDING MARKETING AUTHORIZATIONS AND PRICING AND
REIMBURSEMENT APPROVAL, AS MAY BE NECESSARY TO COMMERCIALIZE THE LICENSED
PRODUCTS THROUGHOUT THE MAJOR COUNTRIES; PROVIDED THAT (I) SUCH OBLIGATION OF
MGI TO USE DILIGENT EFFORTS FOR INDICATIONS OTHER THAN MDS AND AML SHALL NOT
APPLY UNLESS THERE IS CLINICAL DATA THAT DEMONSTRATES A REASONABLE POTENTIAL
THAT A LICENSED PRODUCT WILL HAVE CLINICAL EFFICACY IN THE TREATMENT OF THE
INDICATION AND (II) SUCH OBLIGATION FOR MGI TO USE DILIGENT EFFORTS TO DEVELOP
LICENSED PRODUCTS SHALL ADDITIONALLY BE SUBJECT TO SECTION 5.3.3 BELOW. WITH
RESPECT TO EACH OF THE ADDITIONAL INDICATIONS, HOWEVER, MGI SHALL USE DILIGENT
EFFORTS TO IDENTIFY A LICENSED PRODUCT THAT HAS THE POTENTIAL FOR CLINICAL
EFFICACY FOR THE ADDITIONAL INDICATION. ALL DEVELOPMENT OF LICENSED PRODUCTS
SHALL BE PERFORMED BY MGI IN ACCORDANCE WITH APPLICABLE LAWS, RULES AND
REGULATIONS. WITHOUT LIMITING THE FOREGOING, MGI SHALL USE AT LEAST DILIGENT
EFFORTS TO CONDUCT SUCH DEVELOPMENT AS IS NECESSARY OR DESIRABLE FOR, AND TO
OBTAIN, REGULATORY APPROVALS FOR LICENSED PRODUCTS, CONSISTENT WITH MGI'S
COMMERCIALIZATION PLAN ESTABLISHED IN ACCORDANCE WITH THIS AGREEMENT. IT IS
UNDERSTOOD AND AGREED THAT ALL DEVELOPMENT COSTS THAT SUPERGEN INCURS IN
PERFORMING THE DEVELOPMENT FOR WHICH IT HAS RETAINED RESPONSIBILITY OR CONTROL
PURSUANT TO SECTION 5.2, AND ALL OTHER DEVELOPMENT FOR THE LICENSED PRODUCTS IN
THE TERRITORY, SHALL, AS BETWEEN THE PARTIES, BE AT THE SOLE COST AND EXPENSE OF
MGI COMMENCING WITH THE DATE ON WHICH THIS AGREEMENT IS SIGNED. MGI, ITS
AFFILIATES, AND LICENSEES WILL REASONABLY CONSIDER AND PROMPTLY RESPOND TO ANY
COMMENTS PROVIDED BY SUPERGEN WITH RESPECT TO THE DEVELOPMENT CONDUCTED BY MGI,
ITS AFFILIATES AND LICENSEES.
5.3.2
MINIMUM DEVELOPMENT COSTS. MGI SHALL EXPEND, NO
LESS THAN FIFTEEN MILLION US DOLLARS (US$15,000,000) IN DEVELOPMENT COSTS IN THE
FIRST THIRTY SIX (36) MONTHS OF EFFECTIVE DATE OF THIS AGREEMENT, INCLUDING ANY
COSTS REIMBURSED TO SUPERGEN PURSUANT TO THE PROVISIONS OF SECTION 5.2.1 FOR THE
PERIOD FROM THE DATE OF SIGNING OF THIS AGREEMENT THROUGH THE EFFECTIVE DATE.
5.3.3
DEVELOPMENT OF CERTAIN LICENSED PRODUCTS. MGI'S
OBLIGATION IN SECTION 5.3.1 ABOVE TO USE DILIGENT EFFORTS TO DEVELOP AND OBTAIN
MARKETING AUTHORIZATIONS FOR LICENSED PRODUCTS SHALL NOT INCLUDE THE OBLIGATION
TO USE DILIGENT EFFORTS TO DEVELOP AND OBTAIN MARKETING AUTHORIZATIONS FOR A
LICENSED PRODUCT IN WHICH THE ACTIVE INGREDIENT IS A DECITABINE [*] OR WHICH
COMPRISES A [*] FORMULATION OF DECITABINE UNLESS SUCH LICENSED PRODUCT PROVIDES
A COMMERCIAL ADVANTAGE OVER