GRANTED TO IT PURSUANT TO SECTION 2.1.1.
A-5
1.39
"MAA" MEANS ANY APPLICATION FILED WITH THE RELEVANT REGULATORY
AUTHORITY SEEKING REGULATORY APPROVAL TO MARKET AND SELL A LICENSED PRODUCT
OUTSIDE THE UNITED STATES FOR A PARTICULAR INDICATION IN THE FIELD.
1.40
"MANUFACTURING COST" MEANS, WITH RESPECT TO ANY PRECLINICAL
MATERIALS OR CLINICAL MATERIALS MANUFACTURED BY IMMUNOGEN, IMMUNOGEN'S
FULLY-BURDENED COSTS (INCLUDING THE COSTS ASSOCIATED WITH PRODUCT TESTING AND
RELEASE ACTIVITIES) OF PRODUCING AND PACKAGING SUCH PRECLINICAL MATERIALS OR
CLINICAL MATERIALS, INCLUDING THE SUM OF THE FOLLOWING COMPONENTS: (A) DIRECT
COSTS, INCLUDING (1) MATERIALS DIRECTLY USED IN PRODUCING AND PACKAGING SUCH
PRECLINICAL MATERIALS OR CLINICAL MATERIALS AND (2) WITH RESPECT TO ANY
PRECLINICAL MATERIALS OR CLINICAL MATERIALS OBTAINED BY IMMUNOGEN FROM A THIRD
PARTY AND SUPPLIED TO SANOFI-AVENTIS WITHOUT MODIFICATION, THE AMOUNT PAID BY
IMMUNOGEN TO SUCH THIRD PARTY FOR THE SAME; (B) MANUFACTURING OVERHEAD COSTS
ATTRIBUTABLE TO THE COST OF GOODS UNDER THE FOREGOING CLAUSE (A) (1), INCLUDING
MANUFACTURING AND QUALITY LABOR AND MANUFACTURING AND QUALITY SUPERVISORY
SERVICES, OPERATING AND ADMINISTRATIVE COSTS OF THE MANUFACTURING AND QUALITY
DEPARTMENTS AND OCCUPANCY COSTS WHICH ARE ALLOCABLE TO COMPANY DEPARTMENTS BASED
ON SPACE OCCUPIED OR HEADCOUNT OR ANOTHER REASONABLE ACTIVITY-BASED METHOD; FOR
THE PURPOSE OF CLARITY, ANY COST ALLOCATION SHALL BE (I) IN ANY CASE, APPLIED IN
ACCORDANCE WITH GAAP, AND (II) APPLIED CONSISTENTLY BY IMMUNOGEN IN RELATION TO
ALL OTHER THIRD PARTIES FOR WHICH IMMUNOGEN MANUFACTURES COMPARABLE MATERIALS;
(C) ANY OTHER REASONABLE AND CUSTOMARY OUT-OF-POCKET COSTS BORNE BY IMMUNOGEN
FOR THE TESTING, TRANSPORT, CUSTOMS CLEARANCE, DUTY, INSURANCE AND/OR STORAGE OF
SUCH PRECLINICAL MATERIALS OR CLINICAL MATERIALS; AND (D) IMMUNOGEN'S GENERAL
AND ADMINISTRATIVE COSTS, INCLUDING PURCHASING, HUMAN RESOURCES, PAYROLL,
INFORMATION SYSTEM AND ACCOUNTING, WHICH ARE DIRECTLY ATTRIBUTABLE OR REASONABLY
ALLOCABLE TO COMPANY DEPARTMENTS BASED ON SPACE OCCUPIED OR HEADCOUNT.
1.41
"MAY COMPOUND" MEANS ANY AND ALL MAYTANSINOID COMPOUNDS (INCLUDING,
WITHOUT LIMITATION, MAYTANSINOL, ANSAMITOCINS DM1 AND DM4), WHETHER PRODUCED BY
A BOTANICAL SOURCE, NATURAL FERMENTATION, CHEMICAL SYNTHESIS OR OTHERWISE, AND
SHALL INCLUDE, WITHOUT LIMITATION, ALL VARIANTS, FRAGMENTS OR DERIVATIVES OF ANY
OF THE FOREGOING, IN EACH CASE CONTROLLED BY IMMUNOGEN.
1.42
"NDA" MEANS A NEW DRUG APPLICATION, AS DEFINED IN THE FDCA AND
REGULATIONS PROMULGATED THEREUNDER, OR ANY SUCCESSOR APPLICATION OR PROCEDURE
REQUIRED TO SELL A LICENSED PRODUCT IN THE UNITED STATES FOR A PARTICULAR
INDICATION IN THE FIELD.
1.43
"NET SALES" MEANS THE GROSS AMOUNT INVOICED BY SANOFI-AVENTIS OR ITS
AFFILIATES OR SUBLICENSEES TO THIRD PARTIES IN EACH COUNTRY IN THE TERRITORY FOR
SALES OF EACH LICENSED PRODUCT IN SUCH COUNTRY DURING THE PERIOD IN WHICH
ROYALTIES ARE PAYABLE HEREUNDER WITH RESPECT TO SALES OF SUCH LICENSED PRODUCT
IN SUCH COUNTRY, LESS THE FOLLOWING DEDUCTIONS FROM SUCH GROSS AMOUNTS ABSORBED
OR ACCRUED WITH RESPECT TO SUCH GROSS AMOUNTS: (A) TRADE, CASH AND/OR QUANTITY
DISCOUNTS ALLOWED AND TAKEN DIRECTLY WITH RESPECT TO SUCH SALES, OR REFLECTED IN
THE INVOICED AMOUNT; (B) EXCISE, SALES AND OTHER CONSUMPTION TAXES (INCLUDING
VAT ON THE SALE OF LICENSED PRODUCTS AND EXCLUDING TAXES BASED ON INCOME) AND
CUSTOM DUTIES