OF ANY SUBDIVISION,
AUTHORITY OR REPRESENTATIVE OF ANY SUCH GOVERNMENT.
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1.63
"FTE" SHALL MEAN THE EFFORTS OF ONE FULL-TIME EMPLOYEE (OR
EQUIVALENT PART-TIME EFFORTS OF MORE THAN ONE EMPLOYEE) DEVOTED TO OR IN SUPPORT
OF THE ARQULE RESEARCH ACTIVITIES.
1.64
"FTE FUNDING COMMITMENT" MEANS (A) WITH RESPECT TO THE ARQULE
RESEARCH ACTIVITIES CONDUCTED IN THE FIRST CONTRACT YEAR DURING THE RESEARCH
COLLABORATION PERIOD, THE FUNDING OF * ARQULE FTES AT THE FTE RATE; AND (B) WITH
RESPECT TO THE ARQULE RESEARCH ACTIVITIES CONDUCTED BY ARQULE IN ANY SUBSEQUENT
CONTRACT YEAR DURING THE RESEARCH COLLABORATION PERIOD, THE FUNDING OF THAT
NUMBER OF FTES AS SHALL BE CONSISTENT WITH THE ANNUAL RESEARCH PLAN FOR SUCH
SUBSEQUENT CONTRACT YEAR AND AGREED TO BY THE PARTIES NOT LATER THAN * (*) DAYS
PRIOR TO THE COMMENCEMENT OF SUCH CONTRACT YEAR; PROVIDED, THAT, (I) DS SHALL
HAVE THE RIGHT TO REDUCE THE FTE FUNDING COMMITMENT IN ANY SUBSEQUENT CONTRACT
YEAR TO THE FUNDING AT THE FTE RATE OF A NUMBER OF FTES NO FEWER THAN * OF FTE
FUNDING COMMITMENT THAT IS APPLICABLE TO THE PREVIOUS CONTRACT YEAR, AND
(II) ARQULE'S CONSENT SHALL BE REQUIRED TO INCREASE THE NUMBER OF FTES ABOVE THE
NUMBER IN THE PREVIOUS YEAR. IN THE EVENT THE PARTIES CANNOT AGREE ON THE NUMBER
OF FTE'S IN ANY SUBSEQUENT YEAR, EACH PARTY SHALL GIVE WRITTEN NOTICE TO THE JEC
OF THE NUMBER OF
FTES IT BELIEVES ARE NEEDED TO PERFORM THE ARQULE RESEARCH
ACTIVITIES IN SUCH CONTRACT YEAR AND THE NUMBER OF FTES SHALL BE DECIDED IN
ACCORDANCE WITH SECTION 2.1.5.
UNTIL THE NUMBER OF FTES IS DECIDED,
THE FTE
FUNDING COMMITMENT FOR SUCH CONTRACT YEAR SHALL BE THE FUNDING AT THE FTE RATE
OF A NUMBER OF FTES EQUAL TO ONE HALF OF THE NUMBER OF FTES FUNDED IN THE
PREVIOUS YEAR.
1.65
"FTE RATE" MEANS WITH RESPECT TO THE CONDUCT BY ARQULE OF ARQULE
RESEARCH ACTIVITIES AND FEASIBILITY ASSESSMENT ACTIVITIES, * DOLLARS (US $*) PER
YEAR.
THE FTE RATE INCLUDES ALL SALARY, EMPLOYEE BENEFITS, MATERIALS AND ALL
OTHER EXPENSES INCLUDING SUPPORT STAFF AND OVERHEAD FOR OR ASSOCIATED WITH THE
SCIENTISTS OF A PARTY PERFORMING ACTIVITIES BUT DOES NOT INCLUDE THIRD PARTY
COSTS.
1.66
"HATCH-WAXMAN ACT" MEANS THE DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, AS AMENDED.
1.67
"IND" MEANS: (A) AN INVESTIGATIONAL NEW DRUG APPLICATION AS DEFINED
IN THE FDCA AND REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION
OR PROCEDURE
13
REQUIRED TO INITIATE CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN THE
UNITED STATES; (B) A COUNTERPART OF AN INVESTIGATIONAL NEW DRUG APPLICATION THAT
IS REQUIRED IN ANY OTHER COUNTRY OR REGION IN THE TERRITORY BEFORE BEGINNING
CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN SUCH COUNTRY OR REGION; AND
(C) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE FOREGOING.
1.68
"INDICATION" MEANS ANY HUMAN INDICATION, DISEASE OR CONDITION WHICH
CAN BE TREATED, PREVENTED, CURED OR THE ONSET OR PROGRESSION OF WHICH CAN BE
DELAYED.
FOR PURPOSES OF CLARITY, DISTINCTIONS