CODES,
RULES, AND REGULATIONS THAT HAVE BEEN ENACTED BY A GOVERNMENT AUTHORITY AND
WHICH ARE IN FORCE AS OF THE EFFECTIVE DATE OR COME INTO FORCE DURING THE TERM,
IN EACH CASE TO THE EXTENT THAT THE SAME ARE APPLICABLE TO THE PERFORMANCE BY
THE PARTIES OF THEIR RESPECTIVE OBLIGATIONS UNDER THIS AGREEMENT, INCLUDING,
WITH RESPECT TO THE UNITED STATES, THE PRESCRIPTION DRUG MARKETING ACT, THE
FEDERAL FOOD, DRUG AND COSMETICS ACT OF 1938, AS AMENDED, THE HEALTH INSURANCE
PORTABILITY AND ACCOUNTABILITY ACT, THE FEDERAL ANTI-KICKBACK STATUTE, AND ANY
APPLICABLE FDA REGULATIONS RELATING TO SAMPLING PRACTICES.
1.4
"BUSINESS DAY" SHALL MEAN ANY DAY THAT IS NOT A SATURDAY OR A
SUNDAY OR A DAY ON WHICH THE NEW YORK STOCK EXCHANGE IS CLOSED.
1.5
"BUSINESS OPPORTUNITY" SHALL HAVE THE MEANING SET FORTH IN
SECTION 2.4(A).
1.6
"CALENDAR QUARTER" SHALL MEAN EACH OF THE THREE (3) MONTH PERIODS
ENDING ON MARCH 31, JUNE 30, SEPTEMBER 30, AND DECEMBER 31, PROVIDED THAT THE
FIRST CALENDAR QUARTER DURING THE TERM SHALL COMMENCE ON THE EFFECTIVE DATE AND
END ON MARCH 31, 2009.
1.7
"CALENDAR YEAR" SHALL MEAN EACH TWELVE (12) MONTH PERIOD BEGINNING
ON JANUARY 1 AND ENDING ON DECEMBER 31, PROVIDED THAT THE FIRST CALENDAR YEAR
DURING THE TERM SHALL COMMENCE ON THE EFFECTIVE DATE AND END ON DECEMBER 31,
2009.
1.8
"CHANGE OF CONTROL" SHALL MEAN (A) THE ACQUISITION OF CONTROL OF
UNITED THERAPEUTICS BY A THIRD PARTY OR (B) THE SALE OR OTHER DISPOSITION OF ALL
OR SUBSTANTIALLY ALL OF THE ASSETS OF UNITED THERAPEUTICS TO A THIRD PARTY.
SOLELY FOR PURPOSES OF THE FOREGOING SENTENCE, "CONTROL" SHALL MEAN THE POWER
WHETHER OR NOT EXERCISED, TO DIRECT THE MANAGEMENT AND AFFAIRS OF UNITED
THERAPEUTICS, DIRECTLY OR INDIRECTLY, WHETHER THROUGH THE OWNERSHIP OF VOTING
SECURITIES, BY CONTRACT, OR OTHERWISE.
THE DIRECT OR INDIRECT OWNERSHIP OF
FIFTY PERCENT (50%) OR MORE OF UNITED THERAPEUTICS' OUTSTANDING VOTING
SECURITIES SHALL IN ANY CASE BE DEEMED TO CONFER "CONTROL."
1.9
"COMMERCIALIZE" (AND, WITH CORRELATIVE MEANINGS, THE TERMS
"COMMERCIALIZING" AND "COMMERCIALIZATION") SHALL MEAN ANY AND ALL ACTIVITIES
RELATING TO THE COMMERCIALIZATION OF THE PRODUCT, INCLUDING THE PROMOTION,
DETAILING, DISTRIBUTION, SALE, OFFER FOR SALE, AND IMPORTATION OF THE PRODUCT
AFTER REGULATORY APPROVAL OF THE PRODUCT, EXCLUDING ANY AND ALL MANUFACTURING OF
THE PRODUCT.
2
1.10
"COMMERCIALIZATION PLAN" SHALL HAVE THE MEANING SET FORTH IN
SECTION 6.2.
1.11
"COMMERCIALLY REASONABLE EFFORTS" SHALL MEAN WITH RESPECT TO EACH
PARTY, COMMERCIALLY REASONABLE EFFORTS IN ACCORDANCE WITH THE BUSINESS, LEGAL,
MEDICAL AND SCIENTIFIC JUDGMENT OF A SIMILARLY SITUATED COMPANY, AND IN
ACCORDANCE WITH THE EFFORTS AND RESOURCES A SIMILARLY SITUATED COMPANY WOULD USE
FOR A PRODUCT OWNED BY IT OR TO WHICH IT HAS RIGHTS, WHICH IS OF SIMILAR MARKET
POTENTIAL, AT A SIMILAR STAGE IN ITS PRODUCT LIFE, TAKING INTO ACCOUNT THE
COMPETITIVENESS OF THE MARKETPLACE, THE PROPRIETARY POSITION OF THE PRODUCT, THE
REGULATORY STRUCTURE INVOLVED, THE PROFITABILITY OF THE PRODUCT AND OTHER
RELEVANT FACTORS.
1.12
"COMPETITIVE PRODUCT" SHALL MEAN ANY PHOSPHODIESTERASE 5 INHIBITOR.
1.13
"COMPOUND" SHALL MEAN THE