SALT FORMS, HYDRATES, SOLVATES AND POLYMORPHS OF SUCH LICENSED
COMPOUND, ALL OF WHICH SHALL CONSTITUTE A SINGLE LICENSED COMPOUND.
[***].
1.43.
"LICENSED PRODUCT" MEANS ANY PHARMACEUTICAL PRODUCT CONTAINING AS
AN ACTIVE PHARMACEUTICAL INGREDIENT A LICENSED COMPOUND; PROVIDED, HOWEVER, THAT
SUCH PRODUCT MAY NOT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT HAVING A
COMPOSITION OF MATTER THAT IS COVERED BY SYNTA PATENT RIGHTS UNLESS SUCH ACTIVE
PHARMACEUTICAL INGREDIENT IS A LICENSED COMPOUND.
1.44.
"MAJOR EU COUNTRY" MEANS FRANCE, GERMANY, ITALY, SPAIN OR THE
UNITED KINGDOM.
1.45.
"MAJOR MARKET" MEANS ANY MAJOR EU COUNTRY, JAPAN, OR THE UNITED
STATES.
1.46.
"MANUFACTURE" MEANS ALL ACTIVITIES RELATED TO THE MANUFACTURING OF
A COMPOUND OR PRODUCT, INCLUDING TEST METHOD DEVELOPMENT AND STABILITY TESTING,
FORMULATION, PROCESS DEVELOPMENT, MANUFACTURING SCALE-UP, MANUFACTURING FOR USE
IN NON-CLINICAL AND CLINICAL STUDIES, MANUFACTURING FOR COMMERCIAL SALE,
PACKAGING, RELEASE OF PRODUCT, QUALITY ASSURANCE/QUALITY CONTROL DEVELOPMENT,
QUALITY CONTROL TESTING (INCLUDING IN-PROCESS, IN-PROCESS RELEASE AND STABILITY
TESTING) AND RELEASE OF PRODUCT OR ANY COMPONENT OR INGREDIENT THEREOF, AND
REGULATORY ACTIVITIES RELATED TO ALL OF THE FOREGOING.
1.47.
"MARKETING EXCLUSIVITY" MEANS, WITH RESPECT TO A PHARMACEUTICAL
PRODUCT IN A COUNTRY: (A) THE EXCLUSIVITY AFFORDED TO THE PHARMACEUTICAL PRODUCT
FOR BEING THE FIRST DRUG PRODUCT CONTAINING THE ACTIVE INGREDIENT TO RECEIVE
REGULATORY APPROVAL IN THAT COUNTRY, (B) PEDIATRIC EXCLUSIVITY, OR (C) ORPHAN
DRUG EXCLUSIVITY, BUT ONLY WHEN THE PHARMACEUTICAL PRODUCT DOES NOT ALSO HAVE A
NON-ORPHAN DRUG INDICATION THAT IS NOT PROTECTED BY AN UNEXPIRED EXCLUSIVITY.
1.48.
"MHLW" MEANS THE JAPANESE MINISTRY OF HEALTH, LABOR AND WELFARE AND
ANY SUCCESSOR AGENCY THERETO.
1.49.
"NDA" MEANS A NEW DRUG APPLICATION OR A SUPPLEMENTAL NEW DRUG
APPLICATION, AS DEFINED IN 21 C.F.R. §§314.50 AND 314.70, RESPECTIVELY, FILED
WITH THE FDA WITH RESPECT TO A LICENSED PRODUCT, OR AN EQUIVALENT APPLICATION
FILED WITH THE REGULATORY AUTHORITY OF A COUNTRY IN THE TERRITORY OTHER THAN THE
UNITED STATES, INCLUDING ANY MARKETING AUTHORIZATION APPLICATION FILED WITH THE
EMEA.
1.50.
"NET SALES" MEANS THE AMOUNT CALCULATED BY SUBTRACTING FROM THE
AMOUNT OF ADJUSTED GROSS SALES (AS DEFINED BELOW) A LUMP SUM DEDUCTION OF
(1) [***] PERCENT ([***]%) OF
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.
7
ADJUSTED GROSS SALES, WITH RESPECT TO NET SALES IN THE UNITED STATES, (2) [***]
PERCENT ([***]%) OF ADJUSTED GROSS SALES, WITH RESPECT TO NET SALES IN THE MAJOR
MARKETS (OTHER THAN THE U.S.) AND CANADA, AND (3) [***] PERCENT ([***]%) OF
ADJUSTED GROSS SALES, WITH RESPECT TO NET SALES IN ALL TERRITORIES OTHER THAN
THOSE SET FORTH IN CLAUSE (1) AND (2) ABOVE, IN LIEU OF ALL DEDUCTIONS
CORRESPONDING TO CHARGES ALLOCABLE TO THE SALE OF LICENSED PRODUCT AND PAID BY
ROCHE BUT WHICH ARE NOT ACCOUNTED FOR BY ROCHE, ITS AFFILIATES, ROCHE ENTITIES
AND SUBLICENSEES ON A PRODUCT-BY-PRODUCT BASIS IN THE CALCULATION OF ADJUSTED
GROSS SALES (E.G., OUTWARD FREIGHTS, POSTAGE CHARGES, TRANSPORTATION INSURANCE,
PACKAGING MATERIALS FOR