SUBLICENSE OR OTHER RIGHT TO OR UNDER SUCH ITEM, PATENT OR RIGHT AS
PROVIDED FOR IN THIS AGREEMENT WITHOUT VIOLATING THE TERMS OF ANY AGREEMENT OR
OTHER BINDING ARRANGEMENT WITH ANY THIRD PARTY.
FOR PURPOSES OF THIS
SECTION 1.63,
7
THE CONSENT REFERRED TO IN SECTION 6.12 SHALL BE DEEMED TO HAVE BEEN OBTAINED AS
OF THE EFFECTIVE DATE.
1.64
"CORE TECHNOLOGY" SHALL MEAN THE BMS CORE
TECHNOLOGY OR THE GILEAD CORE TECHNOLOGY, AS THE CASE MAY BE.
1.65
"COST ALLOCATION PROPOSAL" SHALL HAVE THE MEANING
SET FORTH IN SECTION 5.12.
1.66
"COST OF GOODS" SHALL HAVE THE MEANING SET FORTH
IN ANNEX J HERETO.
1.67
"COURT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 15.15.
1.68
"DETAIL" SHALL MEAN AN IN-PERSON PRESENTATION TO
A HEALTH CARE PROVIDER SPECIALIZING IN TREATMENT OF HIV INFECTION OR AIDS, AND
WHO HAS PRESCRIBING AUTHORITY, BY A SALES REPRESENTATIVE WHO IS FULLY EQUIPPED
WITH KNOWLEDGE OF, AND (SUBJECT TO SECTION 5.7) APPROVED MARKETING MATERIALS AND
PRODUCT LABELS AND INSERTS WITH RESPECT TO, THE COMBINATION PRODUCT, IN WHICH
THE CHARACTERISTICS OF THE COMBINATION PRODUCT ARE DESCRIBED BY SUCH SALES
REPRESENTATIVE IN A FAIR AND BALANCED MANNER CONSISTENT WITH THE REQUIREMENTS OF
APPLICABLE LAW AND OF THIS AGREEMENT, AND IN A MANNER THAT IS CUSTOMARY IN THE
INDUSTRY FOR THE PURPOSE OF PROMOTING A PRESCRIPTION PHARMACEUTICAL PRODUCT, BUT
WITHOUT REGARD TO THE POSITION OF THE PRESENTATION WITHIN A CALL TO THE HEALTH
CARE PROVIDER.
FOR THE AVOIDANCE OF DOUBT, A PROMOTIONAL MATERIAL DROP OR
PRODUCT REMINDER SHALL NOT CONSTITUTE A DETAIL.
WHEN USED AS A VERB, TO
"DETAIL" SHALL MEAN TO ENGAGE IN A DETAIL.
1.69
"DETAIL EQUIVALENT AMOUNT" SHALL MEAN, FOR THE
2005 CALENDAR YEAR AND THE 2006 CALENDAR YEAR, [*], AND FOR EACH SUCCESSIVE
CALENDAR YEAR THEREAFTER, SUCH AMOUNT AS ADJUSTED BY THE [*] FOR EACH SUCH
CALENDAR YEAR.
1.70
"DEVELOPING WORLD" SHALL MEAN THE TERRITORY
COMPRISING THE COUNTRIES LISTED IN ANNEX R AND ANY ADDITIONAL COUNTRIES OUTSIDE
THE TERRITORY, CANADA AND EUROPE THAT GILEAD INCLUDES IN ITS GILEAD ACCESS
PROGRAM, AS INDICATED AT THE WEBSITE FOR THE PROGRAM, .
1.71
"DEVELOPMENT ACTIVITIES" SHALL MEAN THE
ACTIVITIES SET FORTH IN THE DEVELOPMENT PLAN, AS UPDATED FROM TIME TO TIME
PURSUANT TO SECTION 3.7 AND, ONLY WITH RESPECT TO PERIODS PRIOR TO THE EFFECTIVE
DATE, ACTIVITIES PURSUANT TO THE MTTA.
1.72
"DEVELOPMENT BUDGET" SHALL MEAN THE BUDGET WITH
RESPECT TO ANY EXPENSES RELATING TO DEVELOPMENT ACTIVITIES FOR THE COMBINATION
PRODUCT THAT ARE CHARGEABLE TO THE JV, AS UPDATED FROM TIME TO TIME PURSUANT TO
SECTION 3.7.
THE INITIAL DEVELOPMENT BUDGET IS ATTACHED HERETO AS ANNEX B.
1.73
"DEVELOPMENT PLAN" SHALL MEAN THE PLAN FOR THE
REGULATORY, CLINICAL, FORMULATION, MANUFACTURING PROCESS AND CMC DATA
DEVELOPMENT ACTIVITIES TO BE CONDUCTED FOR THE COMBINATION PRODUCT, INCLUDING
ANY PHASE IV CLINICAL STUDIES AND MEDICAL INFORMATION AND MEDICAL EDUCATION
PROGRAMS, AS UPDATED FROM TIME TO TIME PURSUANT TO SECTION 3.7.
THE INITIAL
DEVELOPMENT PLAN IS ATTACHED HERETO AS ANNEX B.
8
1.74
"DEVELOPMENT RECORD REQUEST" SHALL HAVE THE