BY, COMES TO CONTROL, OR IS UNDER COMMON CONTROL WITH
SUCH PARTY, AS THE CASE MAY BE. AS USED IN THIS SECTION 1.3, "CONTROL" SHALL
MEAN:
(I) TO POSSESS, DIRECTLY OR INDIRECTLY, THE POWER TO DIRECT THE
MANAGEMENT AND POLICIES OF SUCH PERSON, CORPORATION OR OTHER ENTITY, WHETHER
THROUGH OWNERSHIP OF VOTING SECURITIES OR BY CONTRACT RELATING TO VOTING RIGHTS
OR CORPORATE GOVERNANCE; OR (II) DIRECT OR INDIRECT BENEFICIAL OWNERSHIP OF AT
LEAST FIFTY PERCENT (50%) (OR SUCH LESSER PERCENTAGE WHICH IS THE MAXIMUM
ALLOWED TO BE OWNED BY A FOREIGN CORPORATION IN A PARTICULAR JURISDICTION) OF
THE VOTING SHARE CAPITAL IN SUCH PERSON, CORPORATION OR OTHER ENTITY.
1.4.
"ACQUIRED COMPETING PRODUCT" SHALL MEAN ANY PRODUCT, IN RESPECT OF
WHICH GSK OR ITS AFFILIATES, DURING THE TERM, ACQUIRES THE RIGHTS (BY LICENSE,
PURCHASE OR OTHERWISE) TO PROMOTE, MARKET OR SELL IN THE GSK TERRITORY, WHICH AT
THE TIME OF ACQUISITION: (I) [**]; (II) [**]; OR (III) [**].
1.5.
"ACQUISITION TRANSACTION" SHALL MEAN THE ACQUISITION OF THE ASSETS
OF A THIRD PARTY, WHETHER THROUGH MERGER, PURCHASE OF STOCK REPRESENTING FIFTY
PERCENT (50%) OR MORE OF THE OUTSTANDING VOTING STOCK, PURCHASE OF ALL OR
SUBSTANTIALLY ALL OF THE ASSETS OF SUCH ENTITY OR OTHERWISE.
1.6.
"BLOCKING PATENT" MEANS ANY PATENT ISSUED TO A THIRD PARTY THAT
WOULD BE INFRINGED BY THE MANUFACTURE, USE, SALE, OFFER FOR SALE OR IMPORTATION
OF THE PRODUCT IN THE GSK TERRITORY.
CONFIDENTIAL
1.7.
"BULK TABLETS" SHALL MEAN FINISHED TABLETS CONTAINING THE ACTIVE
INGREDIENT WHICH MEETS THE RELEVANT SPECIFICATIONS, TO BE DEFINED MORE
SPECIFICALLY IN THE SUPPLY AGREEMENT, AND TO BE SHIPPED TO GSK BY SEPRACOR IN
BULK IN THE MANNER SET FORTH IN THE SUPPLY AGREEMENT, AND THEN TO BE PACKAGED AS
THE PRODUCT BY OR ON BEHALF OF GSK.
1.8.
"BUSINESS DAY" SHALL MEAN A DAY OTHER THAN A (I) SATURDAY,
(II) SUNDAY OR (III) PUBLIC HOLIDAY IN THE UNITED STATES OR ENGLAND. FOR THE
AVOIDANCE OF DOUBT, REFERENCES IN THIS AGREEMENT TO "DAYS" SHALL MEAN CALENDAR
DAYS.
1.9.
"CALENDAR QUARTER" SHALL MEAN A PERIOD OF THREE (3) CONSECUTIVE
MONTHS DURING A CALENDAR YEAR BEGINNING ON AND INCLUDING 1ST JANUARY, 1ST APRIL,
1ST JULY OR 1ST OCTOBER.
1.10.
"CALENDAR YEAR" SHALL MEAN A PERIOD OF TWELVE (12) CONSECUTIVE
MONTHS BEGINNING ON AND INCLUDING 1ST JANUARY.
1.11.
"CLINICAL SUPPLIES" SHALL MEAN THOSE QUANTITIES OF BULK TABLETS AND
PLACEBO TO BE SUPPLIED BY SEPRACOR TO GSK IN THE MANNER TO BE SET FORTH IN THE
SUPPLY AGREEMENT FOR USE IN THE FOLLOWING SCENARIOS WHERE THE BULK TABLETS ARE
NOT TO BE PACKAGED AND LABELED FOR COMMERCIAL SALE: (I) ANY DEVELOPMENTAL STUDY;
(II) VALIDATION STUDIES OR ANY OTHER STUDIES TO CONFIRM PACKAGING OR FORMULATION
OR OTHER MANUFACTURING REQUIREMENTS; OR (III) FOR ANY OTHER NON-COMMERCIAL USES
NECESSARY FOR OBTAINING THE MARKETING APPROVAL FOR THE PRODUCT IN ANY COUNTRY IN
THE GSK TERRITORY.
1.12.
"COMMERCIALIZATION STUDIES" SHALL MEAN ANY CLINICAL STUDIES GSK
WISHES TO BE CONDUCTED BY OR ON BEHALF OF GSK IN THE GSK TERRITORY IN SUPPORT OF
GSK'S