ECONOMIC VALUE TAKING INTO
ACCOUNT THE THEN STATE OF SCIENTIFIC KNOWLEDGE AND AVAILABLE RESOURCES.
4
1.18
"COMPOUND" SHALL MEAN A SINGLE ACTIVE INGREDIENT OR A COMBINATION OF TWO
OR MORE ACTIVE INGREDIENTS TOGETHER WITH PRO-DRUGS, METABOLITES, RACIMERS,
ISOMERS, ENANTIOMERS, SALTS, ESTERS, FREE-BASE, FREE-ACID AND OPTICALLY ACTIVE
FORMS OF ANY OF THE FOREGOING WITH RESPECT TO WHICH SCREENING HAS BEEN CONDUCTED
IN CONNECTION WITH THE RESEARCH PROGRAM.
1.19
"CONFIDENTIAL INFORMATION" SHALL HAVE THE MEANING ASCRIBED TO IT IN
SECTION 6.1 HEREOF.
1.20
"DISCUSSION PERIOD" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 5.11
HEREOF.
1.21
"DRUG PRODUCT" RESULTING FROM A DRUG PRODUCT CANDIDATE SHALL MEAN A
FINISHED DOSAGE FORM WHICH IS APPROVED BY A REGULATORY AUTHORITY FOR
ADMINISTRATION TO PATIENTS AS A PHARMACEUTICAL.
1.22
"DRUG PRODUCT CANDIDATE" SHALL MEAN ANY CLINICAL DEVELOPMENT CANDIDATE
FOR WHICH A CLINICAL DEVELOPMENT PROGRAM HAS COMMENCED UNDER SECTION 3.1
HEREUNDER.
1.23
"EARLY TERMINATION DECISION" SHALL HAVE THE MEANING ASCRIBED TO IT IN
SECTION 10.4.
1.24
"EFFECTIVE DATE" SHALL BE THE DATE ON WHICH THIS AGREEMENT IS FULLY
EXECUTED AND DELIVERED.
1.26
"FIELD" SHALL MEAN THE TREATMENT OF CONDITIONS OR DISEASES IN THE CF
FIELD, ASTHMA, CHRONIC BRONCHITIS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
1.26
"FIRST SALE" SHALL MEAN THE FIRST SALE OF A DRUG PRODUCT BY COMBINATORX
OR AN AFFILIATE, LICENSEE OR SUBLICENSEE OF COMBINATORX IN THE TERRITORY
FOLLOWING REGULATORY
5
APPROVAL OF THE DRUG PRODUCT, OR IF NO SUCH REGULATORY APPROVAL OR SIMILAR
MARKETING APPROVAL IS REQUIRED, THEN THE DATE ON WHICH THE DRUG PRODUCT IS FIRST
COMMERCIALLY LAUNCHED. FOR THE AVOIDANCE OF DOUBT, SALES PRIOR TO RECEIPT OF ALL
REGULATORY APPROVALS, SUCH AS SO-CALLED "TREATMENT IND SALES," "NAMED PATIENT
SALES" AND "COMPASSIONATE USE SALES," SHALL NOT BE CONSTRUED AS A FIRST SALE.
1.27
"GO DECISION" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 10.4.
1.28
"INTELLECTUAL PROPERTY" MEANS ANY DISCOVERY, INVENTION, FORMULATION,
KNOW-HOW, METHOD, TECHNOLOGICAL DEVELOPMENT, ENHANCEMENT, MODIFICATION,
IMPROVEMENT, WORK OF AUTHORSHIP, COMPUTER SOFTWARE (INCLUDING, BUT NOT LIMITED
TO, SOURCE CODE AND EXECUTABLE CODE), PATENT, PATENT APPLICATIONS, TRADE SECRETS
AND DOCUMENTATION THEREOF, DATA OR COLLECTION OF DATA, WHETHER PATENTABLE OR
NOT, OR SUSCEPTIBLE TO COPYRIGHT OR ANY OTHER FORM OF LEGAL PROTECTION.
1.29
"INTERRUPTION" MEANS THE CESSATION OF COMMERCIALLY REASONABLE EFFORTS
DIRECTED TOWARD DEVELOPMENT AND COMMERCIALIZATION OF ACTIVITIES PRIOR TO
COMMERCIAL LAUNCH OF A DRUG PRODUCT IN THE FIELD FOR MORE THAN [*].
1.30
"INTERRUPTION LICENSE DATA PACKAGE" SHALL MEAN ALL INFORMATION KNOWN BY
COMBINATORX ABOUT A CLINICAL DEVELOPMENT CANDIDATE OR A DRUG PRODUCT CANDIDATE,
AS THE CASE MAY BE, WHICH CFFT REASONABLY NEEDS TO PURSUE THE INTERRUPTION
LICENSE AND WHICH WAS GENERATED OR DEVELOPED PURSUANT TO THIS AGREEMENT. WITHOUT
LIMITATION, SUCH INFORMATION SHALL INCLUDE SCREENING AND ASSAY DATA; RESULTS
FROM ANIMAL MODEL STUDIES; COPIES OF RELEVANT SECTIONS FROM LABORATORY
NOTEBOOKS; REPORTS, RESULTS AND DATA RELATED TO PK, ADME AND TOXICOLOGY STUDIES;
PROTOCOLS AND CLINICAL STUDY REPORTS.
6
1.31
"JOINT DEVELOPMENT COMMITTEE" OR "JDC" SHALL HAVE THE MEANING ASCRIBED TO
IT IN SECTION 3.2
HEREOF
1.32
"JOINT RESEARCH COMMITTEE" OR