BE MODIFIED FROM TIME TO TIME IN ACCORDANCE WITH THE MANUFACTURING AND SUPPLY
AGREEMENT.
1.45
"PROMOTION" OR "PROMOTE" SHALL MEAN THE MARKETING
AND ADVERTISING OF THE PRODUCT IN THE FIELD IN THE TERRITORY IN ACCORDANCE WITH
THE COMMERCIALIZATION PLAN, INCLUDING MEDICAL EDUCATION, INFORMATION AND
COMMUNICATION, MARKET DEVELOPMENT AND MEDICAL LIAISON ACTIVITIES.
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1.46
"PULMONARY ARTERIAL HYPERTENSION" OR "PAH" SHALL
MEAN ALL WHO CLASSIFICATIONS OF PULMONARY ARTERIAL HYPERTENSION IDENTIFIED IN
THE VENICE 2003 REVISED CLASSIFICATION SYSTEM.
1.47
"QUALITY AGREEMENT" HAS THE MEANING SET FORTH IN
SECTION 4.7.
1.48
"REASONABLE COST" SHALL MEAN, WITH RESPECT TO A
PARTY, THE REASONABLE COSTS AND EXPENSES (INCLUDING FULL TIME EQUIVALENT COSTS
AND THIRD PARTY COSTS) AS THEN CALCULATED, FROM TIME TO TIME, BY SUCH PARTY FOR
ITS INTERNAL ACCOUNTING PURPOSES, SUCH CALCULATION PERFORMED CONSISTENTLY WITH
THE PRACTICE ACROSS SUCH PARTY'S ORGANIZATION.
IN ANY CIRCUMSTANCE WHERE
REASONABLE COSTS ARE EXPECTED TO EXCEED ONE HUNDRED THOUSAND DOLLARS, THE
PARTIES WILL DEVELOP A BUDGET FOR SUCH CIRCUMSTANCE AND AGREE UPON A FULL TIME
EQUIVALENT RATE THAT IS APPROPRIATE FOR SUCH CIRCUMSTANCE.
1.49
"REGULATORY APPROVAL" SHALL MEAN ANY APPROVALS,
LICENSES, REGISTRATIONS OR AUTHORIZATIONS OF ANY REGULATORY AUTHORITY, WHETHER
OR NOT CONDITIONAL, THAT ARE NECESSARY FOR THE COMMERCIAL SALE OF THE PRODUCT IN
THE FIELD IN THE TERRITORY AND OBTAINED AS A RESULT OF ACTIVITIES UNDER THIS
AGREEMENT.
1.50
"REGULATORY AUTHORITY" SHALL MEAN ANY AND ALL
SUPRANATIONAL, NATIONAL, OR REGIONAL, STATE, PROVINCIAL OR OTHER LOCAL
GOVERNMENT, COURT, GOVERNMENTAL AGENCY, AUTHORITY, BOARD, BUREAU,
INSTRUMENTALITY, REGULATORY AGENCY, DEPARTMENT, BUREAU, COMMISSION, COUNCIL OR
OTHER GOVERNMENT ENTITY, WHOSE APPROVAL OR AUTHORIZATION IS NECESSARY FOR, OR TO
WHOM NOTICE MUST BE GIVEN PRIOR TO, THE DEVELOPMENT, MANUFACTURE, USE OR
COMMERCIALIZATION OF THE PRODUCT IN THE TERRITORY OR THE DESIGNATION OF THE
PRODUCT AS AN ORPHAN DRUG (OR EQUIVALENT DESIGNATION) IN THE TERRITORY,
INCLUDING, WITH RESPECT TO THE UNITED STATES, THE FDA.
1.51
"REGULATORY FILINGS" SHALL MEAN ALL APPLICATIONS,
FILINGS, DOSSIERS AND THE LIKE (EXCLUDING ROUTINE ADVERSE EVENT EXPEDITED OR
PERIODIC REPORTING), SUBMITTED TO A REGULATORY AUTHORITY IN THE TERRITORY FOR
THE PURPOSE OF OBTAINING REGULATORY APPROVAL FROM THAT REGULATORY AUTHORITY IN
THE TERRITORY, BUT DO NOT INCLUDE SUBMISSION OF PROMOTIONAL MATERIALS TO
DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMUNICATIONS OF THE FDA (DDMAC).
1.52
"SAFETY AGREEMENT" SHALL HAVE THE MEANING SET FORTH
IN SECTION 5.5(A).
AN EXAMPLE OF THE TABLE OF CONTENTS OF A SAFETY AGREEMENT IS
ATTACHED HERETO AS EXHIBIT 1.52.
1.53
"SECONDARY INDICATION" SHALL MEAN ANY INDICATION IN
THE FIELD OTHER THAN PAH.
1.54
"TERM" SHALL HAVE THE MEANING SET FORTH IN
SECTION 13.1.
1.55
"TERRITORY" SHALL MEAN THE UNITED STATES OF AMERICA
AND PUERTO RICO, AND UNITED STATES OF AMERICA-BASED DEPARTMENT OF DEFENSE AND/OR
DEPARTMENT OF VETERANS AFFAIRS DEPOTS TO THE EXTENT THAT SUCH AGENCIES PURCHASE
PRODUCT IN THE UNITED STATES.
1.56
"THIRD PARTY" SHALL MEAN ANY ENTITY OTHER THAN A
PARTY OR ITS AFFILIATES.
1.57
"UNITED THERAPEUTICS COMMERCIALIZATION ACTIVITIES"
SHALL HAVE THE MEANING SET FORTH IN SECTION 6.3(A).
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1.58
"UNITED THERAPEUTICS KNOW-HOW" SHALL MEAN
INFORMATION, INCLUDING ANY AND