TESTING AND EXPERIENCE
IN RELATION TO ANY LICENSED PRODUCT AND (III) THE CHEMICAL COMPOSITION,
SYNTHESIS, FORMULATION, COMPOUNDING, AND MANUFACTURING AND QUALITY CONTROL
TESTING OF ANY LICENSED PRODUCT, TO THE EXTENT REASONABLY REQUIRED FOR PURPOSES
OF ANY APPLICATION FOR MARKETING AUTHORIZATION FOR A LICENSED PRODUCT.
SUPPORTING DATA SHALL ALSO INCLUDE, BUT IS NOT LIMITED TO, COPIES OF ANNUAL
REPORTS, INTEGRATED STUDY REPORTS, PROTOCOLS FOR CLINICAL RESEARCH AND
PRE-CLINICAL STUDIES, PROTOCOL CHANGES AND AMENDMENTS, CHEMISTRY, MANUFACTURING
AND CONTROL
(CMC) SECTIONS AND AMENDMENTS, SAFETY DATA, CLINICAL DATABASES,
CASE REPORT FORMS AND ACCESS TO PATIENT RECORDS, TOXICITY, SAFETY AND METABOLISM
REPORTS AND DATA, AND PHARMACOKINETIC DATA AND REPORTS AND RELATING TO ANY
LICENSED PRODUCT, AS WELL AS, IN GENERAL, DATA OR INFORMATION WHICH WOULD
TYPICALLY BE PART OF ANY SUBMISSION TO FDA OR OTHER REGULATORY AUTHORITY FOR THE
PURPOSE OF OBTAINING APPROVAL OF ANY LICENSED PRODUCT FOR ANY INDICATION.
1.44
"TERRITORY" SHALL MEAN ALL OF THE COUNTRIES OF
THE WORLD, AND THEIR TERRITORIES AND POSSESSIONS (EXCLUDING COUNTRIES TO THE
EXTENT MGI'S RIGHTS THEREIN HAVE BEEN TERMINATED UNDER THIS AGREEMENT PURSUANT
TO THE PROVISIONS OF THIS AGREEMENT).
1.45
"THIRD PARTY" SHALL MEAN ANY PARTY OTHER THAN
MGI, SUPERGEN AND THEIR AFFILIATES.
1.46
"THIRD PARTY AGREEMENTS" SHALL MEAN THOSE
AGREEMENTS AND PURCHASE ORDERS LISTED IN EXHIBIT 1.46.
8
1.47
"U.S." SHALL MEAN THE UNITED STATES OF AMERICA,
AND ITS TERRITORIES AND POSSESSIONS.
IN ADDITION, THE FOLLOWING TERMS SHALL HAVE THE MEANING DESCRIBED IN THE
CORRESPONDING SECTION OF THIS AGREEMENT. OTHER TERMS MAY BE DEFINED THROUGHOUT
THE AGREEMENT AND ITS EXHIBITS.
Term
Section Defined
"Agreement"
Preamble
"Annual Net Sales"
3.3.1
"Claim"
13.1
"Commercialization Plan"
4.1
"Decitabine Improvements"
9.1
"Diligence Milestones"
7.8
"Enforcement Actions"
9.6
"Existing Licensed Product"
1.25
"Indemnitee," "Indemnitor"
13.3
"Infringement Actions"
9.5
"Joint Steering Committee"
4.2
"Liabilities"
13.1
"MDS"
Recitals
"MGI"
Preamble
"MGI Indemnitees"
13.2
"Milestone Region"
3.2
"Party," "Parties"
Preamble
"Project Leader"
4.3
"Public Disclosure"
16.9
"Registration Trial"
7.8
"SuperGen"
Preamble
"SuperGen Indemnitees"
13.1
"Sales Materials"
7.5
"Wind-down Period"
15.3
2.
LICENSE
2.1
LICENSE. SUBJECT TO THE TERMS AND CONDITIONS
OF THIS AGREEMENT, SUPERGEN HEREBY GRANTS TO MGI AN EXCLUSIVE, NON-TRANSFERABLE
(EXCEPT AS EXPRESSLY AUTHORIZED IN THIS AGREEMENT), ROYALTY-BEARING LICENSE
UNDER THE LICENSED PATENTS AND LICENSED KNOW-HOW TO DEVELOP, MAKE, HAVE MADE,
USE, IMPORT, OFFER FOR SALE, AND SELL, THE LICENSED PRODUCTS IN THE TERRITORY.
NOTWITHSTANDING THE FOREGOING, SUPERGEN RESERVES THE EXCLUSIVE RIGHT TO PERFORM
THE ACTIVITIES FOR WHICH IT IS RESPONSIBLE AS SET FORTH IN SECTION 5.2, THE
NON-EXCLUSIVE RIGHT TO PERFORM PRE-CLINICAL AND NON-CLINICAL DEVELOPMENT AND
RETAINS THOSE RIGHTS NECESSARY FOR IT TO MEET ITS OBLIGATIONS UNDER THE THIRD
PARTY AGREEMENTS THAT ARE NOT ACCEPTED BY MGI PURSUANT TO THE PROVISIONS OF
SECTION 9.8. SUPERGEN ALSO RESERVES ALL OTHER RIGHTS NOT EXPRESSLY GRANTED
HEREIN, AND NO OTHER RIGHTS SHALL BE CONSIDERED GRANTED BY SUPERGEN BY
IMPLICATION, ESTOPPEL, RELIANCE, OR OTHERWISE. NOTWITHSTANDING ANYTHING TO THE
CONTRARY, NO RIGHTS OR LICENSES ARE GRANTED BY SUPERGEN IN THIS AGREEMENT WITH
RESPECT TO ANY
9
active ingredient, other than Decitabine or with respect to