MEAN THE
DESIGNATIONS OF DECITABINE AS AN ORPHAN PRODUCT BY THE OFFICE OF ORPHAN PRODUCTS
OF THE FDA, OR OTHER REGULATORY AUTHORITY IN THE TERRITORY, AS SET FORTH IN
EXHIBIT 1.36.
1.37
"PATENT RIGHTS" SHALL MEAN ANY AND ALL RIGHTS
UNDER ANY OF THE FOLLOWING: (I) A UNITED STATES, INTERNATIONAL OR FOREIGN
PATENT, UTILITY MODEL, DESIGN REGISTRATION, CERTIFICATE OF INVENTION, PATENT OF
ADDITION OR SUBSTITUTION, OR OTHER GOVERNMENTAL GRANT FOR THE PROTECTION OF
INVENTIONS OR INDUSTRIAL DESIGNS ANYWHERE IN THE WORLD, INCLUDING ANY REISSUE,
RENEWAL, RE-EXAMINATION OR EXTENSION THEREOF; AND (II) ANY APPLICATION FOR ANY
OF THE FOREGOING, INCLUDING ANY INTERNATIONAL, PROVISIONAL, DIVISIONAL,
CONTINUATION, CONTINUATION-IN-PART, OR CONTINUED PROSECUTION APPLICATION.
1.38
"PRODUCT TRADEMARK" SHALL MEAN (I) WITH RESPECT
TO THE EXISTING LICENSED PRODUCT, THE DACOGEN TRADEMARK AND ALL OTHER EXISTING
LICENSED PRODUCT SPECIFIC TRADEMARKS AND LOGOS
UNDER WHICH THE EXISTING
LICENSED PRODUCT IS MARKETED AND DISTRIBUTED IN ACCORDANCE WITH THIS AGREEMENT;
AND (II) WITH RESPECT TO EACH LICENSED PRODUCT, OTHER THAN THE EXISTING LICENSED
PRODUCT,
THE LICENSED PRODUCT SPECIFIC TRADEMARKS AND LOGOS UNDER WHICH SUCH
LICENSED PRODUCT IS MARKETED OR DISTRIBUTED IN ACCORDANCE WITH THIS AGREEMENT.
1.39
"REGULATORY AUTHORITY" SHALL MEAN, IN RESPECT OF
A JURISDICTION, ANY AGENCY, DEPARTMENT, BUREAU OR OTHER GOVERNMENTAL ENTITY WITH
AUTHORITY OVER THE DEVELOPMENT, MANUFACTURE, USE OR SALE (INCLUDING APPROVAL OF
NDAS AND OTHER MAAS) WITH RESPECT TO ANY LICENSED PRODUCT IN THE JURISDICTION,
INCLUDING THE FDA, EMEA, AND KOSEISHO.
1.40
"REGULATORY DOCUMENTATION" MEANS, WITH RESPECT TO
A LICENSED PRODUCT, ALL FILINGS AND SUPPORTING DOCUMENTS SUBMITTED TO ANY AND
ALL REGULATORY AUTHORITIES RELATING TO SUCH
7
Licensed Product, and all data and information contained therein, including any
INDs, MAAs (including NDAs), Drug Master Files, investigator's brochures,
correspondence to and from Regulatory Authorities, minutes from teleconferences
and meetings with Regulatory Authorities, registrations and licenses, regulatory
drug lists, advertising and promotion documents shared with Regulatory
Authorities, product labeling, adverse event files, complaint files and
Manufacturing records.
1.41
"STOCK PURCHASE AGREEMENT" SHALL MEAN THAT
CERTAIN COMMON STOCK PURCHASE AGREEMENT ENTERED INTO BETWEEN MGI AND SUPERGEN,
PURSUANT TO WHICH MGI IS PURCHASING COMMON STOCK OF SUPERGEN, OF EVEN DATE
HEREWITH.
1.42
"SUBLICENSING REVENUE" SHALL MEAN ALL AMOUNTS
PAYABLE TO MGI AND ITS AFFILIATES FROM LICENSEES AND THEIR AFFILIATES AS A
RESULT OF THE GRANT OF RIGHTS, OR ANY OTHER ARRANGEMENT, TO MARKET, SELL, OR
OTHERWISE DISTRIBUTE ANY AND ALL LICENSED PRODUCTS, INCLUDING WITHOUT LIMITATION
LICENSE FEES, MILESTONE PAYMENTS, PREMIUMS ON EQUITY, PREMIUMS ON PAYMENT FOR
RESEARCH AND DEVELOPMENT, AND ROYALTIES, BUT EXCLUDING (I) ROYALTIES BASED UPON
NET SALES FOR WHICH A ROYALTY IS PAID TO SUPERGEN UNDER THIS AGREEMENT, (II)
REIMBURSEMENT FOR RESEARCH OR DEVELOPMENT ACTIVITIES PERFORMED BY OR ON BEHALF
OF THE LICENSEE
TO THE EXTENT REIMBURSED AT FAIR MARKET VALUE, AND (III)
AMOUNTS PAID BY THE LICENSEE
TO PURCHASE LICENSED PRODUCT FROM MGI OR ITS
AFFILIATES AT THE FAIR MARKET VALUE.
1.43
"SUPPORTING DATA" SHALL MEAN ALL DATA AND
INFORMATION RELATING TO (I) THE PHARMACOLOGICAL OR TOXICOLOGICAL PROPERTIES OF
ANY LICENSED PRODUCT, (II) ANY PRE-CLINICAL OR CLINICAL