A LICENSED
PRODUCT THAT IS A PHARMACEUTICAL PREPARATION INCORPORATING TWO OR MORE
THERAPEUTICALLY ACTIVE INGREDIENTS, INCLUDING A CANDIDATE DRUG, AS ITS MAIN
ACTIVE INGREDIENTS.
NOTWITHSTANDING THE FOREGOING, DRUG DELIVERY VEHICLES,
ADJUVANTS, AND EXCIPIENTS SHALL NOT BE DEEMED TO BE "THERAPEUTICALLY ACTIVE
INGREDIENTS," AND THEIR PRESENCE SHALL NOT BE DEEMED TO CREATE A COMBINATION
PRODUCT UNDER THIS SECTION 1.17.
1.18
"COMPOUND" SHALL MEAN A SMALL MOLECULE MODULATOR
OF MEK, THE MECHANISM OF WHICH IS DIRECT BINDING AND INHIBITION OF MEK, WHEREIN
SUCH CHEMICAL ENTITY IS IDENTIFIED BY ARRAY OR AZ USING ARRAY EXISTING
TECHNOLOGY, AZ EXISTING TECHNOLOGY OR COLLABORATION TECHNOLOGY PRIOR TO THE END
OF THE RESEARCH TERM.
1.19
"CONTRACT YEAR" SHALL MEAN A YEAR OF 365 DAYS (OR
366 DAYS IN A LEAP YEAR) BEGINNING ON THE EFFECTIVE DATE AND ENDING ONE (1) YEAR
THEREAFTER AND SO ON YEAR-BY-YEAR.
"CONTRACT YEAR ONE" SHALL MEAN THE FIRST
SUCH YEAR; "CONTRACT YEAR TWO" SHALL MEAN THE SECOND SUCH YEAR, AND SO ON,
YEAR-BY-YEAR.
1.20
"CONTROL," "CONTROLS," "CONTROLLED" OR
"CONTROLLING" SHALL MEAN POSSESSION OF THE ABILITY TO GRANT THE LICENSES OR
SUBLICENSES AS PROVIDED HEREIN WITHOUT VIOLATING THE TERMS OF ANY AGREEMENT OR
OTHER ARRANGEMENTS WITH ANY THIRD PARTY.
3
1.21
"DEVELOPMENT COMMITTEE" SHALL MEAN THE TEAM OF AZ
PERSONNEL AND ONE (1) ARRAY REPRESENTATIVE FORMED IN ACCORDANCE WITH SECTION 3.2
TO DISCUSS AND REPORT ON THE DEVELOPMENT OF A LICENSED PRODUCT.
1.22
"DEVELOPMENT CRITERIA" SHALL HAVE THE MEANING
DESCRIBED IN SECTION 3.2 HEREOF.
1.23
"DEVELOPMENT MILESTONE" SHALL MEAN A MILESTONE
DESCRIBED IN SECTION 6.4.
1.24
"DEVELOPMENT PLAN" SHALL MEAN THE WORKPLAN WITH
RESPECT TO THE DEVELOPMENT OF A LICENSED PRODUCT AS SET FORTH IN SECTION 3.2.
1.25
"EXCLUSIVITY PERIOD" SHALL MEAN THE PERIOD OF
TIME COMMENCING WITH THE EFFECTIVE DATE AND ENDING UPON THE FIRST ANNIVERSARY OF
THE END OF THE RESEARCH TERM.
1.26
"EXISTING TECHNOLOGY" SHALL MEAN EITHER OR BOTH
OF ARRAY EXISTING TECHNOLOGY AND/OR AZ EXISTING TECHNOLOGY.
1.27
"FDA" SHALL MEAN, WITH RESPECT TO THE UNITED
STATES, THE U.S. FOOD AND DRUG ADMINISTRATION, ANY SUCCESSOR ENTITY THERETO, OR
ANY EQUIVALENT FOREIGN REGULATORY AUTHORITY(IES) IN THE PARTICULAR COUNTRY OF
THE TERRITORY.
1.28
"FIELD" SHALL MEAN THE DIAGNOSIS, TREATMENT,
PALLIATION, AND/OR PREVENTION OF CANCER IN HUMANS.
1.29
"FTE" SHALL MEAN A FULL-TIME PERSON DEDICATED TO
THE RESEARCH PROGRAM OR THE PROCESS PROGRAM, OR IN THE CASE OF LESS THAN A
FULL-TIME DEDICATED PERSON, A FULL-TIME, EQUIVALENT PERSON YEAR, BASED UPON A
TOTAL OF ONE THOUSAND EIGHT HUNDRED EIGHTY (1,880) HOURS PER YEAR OF WORK IN
CONNECTION WITH THE RESEARCH PROGRAM OR THE PROCESS PROGRAM.
1.30
"IND" SHALL MEAN AN INVESTIGATIONAL NEW DRUG
APPLICATION FILED WITH THE FDA AS MORE FULLY DEFINED IN 21 C.F.R. § 312.3 OR ITS
EQUIVALENT IN ANY COUNTRY.
1.31
"INFORMATION" SHALL MEAN INFORMATION AND
MATERIALS RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT AND INCLUDING
(I) TECHNIQUES AND DATA, INCLUDING, BUT NOT LIMITED TO, SCREENS, MODELS,
INVENTIONS, METHODS, TEST DATA, INCLUDING BUT NOT LIMITED TO, PHARMACOLOGICAL,
TOXICOLOGICAL AND CLINICAL TEST DATA, ANALYTICAL AND QUALITY CONTROL DATA,
MARKETING,