COMMERCIAL SALE OF
SUCH
LICENSED PRODUCT IN SUCH COUNTRY.
19
1.101
"SNDA" MEANS A SUPPLEMENTAL NEW DRUG APPLICATION, AS
DEFINED IN THE FDCA AND APPLICABLE REGULATIONS PROMULGATED THEREUNDER.
1.102
"SUBLICENSEE" MEANS ANY THIRD PARTY TO WHICH DS GRANTS
A SUBLICENSE UNDER THE LICENSES GRANTED TO IT UNDER SECTION 7.5.
1.103
"TARGET" MEANS A KINASE.
1.104
"TARGET SPECIFICITY PANEL" MEANS THE LIST OF TARGETS
SET FORTH IN THE MOST RECENT ANNUAL RESEARCH PLAN FOR THE PURPOSE OF TESTING THE
SPECIFICITY OF COLLABORATION COMPOUNDS.
1.105
"TECHNOLOGY" MEANS, COLLECTIVELY, INVENTIONS,
DISCOVERIES, IMPROVEMENTS, TRADE SECRETS AND PROPRIETARY METHODS, WHETHER OR NOT
PATENTABLE, INCLUDING WITHOUT LIMITATION: (A) METHODS OF PRODUCTION OR USE OF,
AND STRUCTURAL AND FUNCTIONAL INFORMATION PERTAINING TO, CHEMICAL COMPOUNDS; AND
(B) COMPOSITIONS OF MATTER, DATA, FORMULATIONS, PROCESSES, TECHNIQUES, KNOW-HOW
AND RESULTS (INCLUDING, WITHOUT LIMITATION, ANY NEGATIVE RESULTS).
1.106
"TERMINATED COMPOUNDS" MEANS (A) ALL COLLABORATION
COMPOUNDS UPON ANY TERMINATION OF THIS AGREEMENT BY ARQULE PURSUANT TO
SECTION 10.2.2, 10.2.3 OR 10.2.4 OR BY DS PURSUANT TO SECTION 10.2.1; (B) THE
RELEVANT COLLABORATION COMPOUNDS BINDING TO THE DS TARGET FOR WHICH DS'S LICENSE
IS TERMINATED BY ARQULE PURSUANT TO SECTION 10.2.2 DUE TO FAILURE OF DS TO MEET
ITS DILIGENCE OBLIGATIONS, AS PROVIDED IN SECTION 4.7(B); AND (C) THE RELEVANT
COLLABORATION COMPOUNDS BINDING TO ANY ABANDONED DS TARGET.
1.107
"TERRITORY" MEANS ALL COUNTRIES AND TERRITORIES OF THE
WORLD.
1.108
"THIRD PARTY" MEANS A PERSON OTHER THAN DS AND ARQULE
AND THEIR RESPECTIVE AFFILIATES.
1.109
"THIRD PARTY DATA PROVIDER" MEANS IMS HEALTH AND/OR
ANY OTHER THIRD PARTY APPROVED BY THE JEC THAT PERFORMS MARKET ANALYSES AND
PROVIDES SALES DATA FOR THE BIOTECHNOLOGY OR PHARMACEUTICAL INDUSTRY.
20
1.110
"TOXICOLOGY STUDY" MEANS THE GLP TOXICOLOGY STUDIES TO
BE CONDUCTED AS PART OF THE PRECLINICAL STUDIES WITH RESPECT TO A PRIMARY
DEVELOPMENT COMPOUND OR A BACKUP COMPOUND, AS DESCRIBED IN THE ANNUAL RESEARCH
PLAN.
1.111
"UNANIMOUS DECISION" MEANS ANY DECISION OF THE JEC
THAT IS NOT DESIGNATED HEREIN AS AN ARQULE DECISION OR A DS DECISION.
1.112
"UNITED STATES" MEANS THE UNITED STATES OF AMERICA AND
ITS TERRITORIES AND POSSESSIONS (INCLUDING THE DISTRICT OF COLUMBIA, PUERTO RICO
AND THE U.S. VIRGIN ISLANDS).
1.113
"US CO-COMMERCIALIZATION COMMITTEE" OR "USCC" MEANS
THE COMMITTEE COMPOSED OF ARQULE AND DS REPRESENTATIVES ESTABLISHED PURSUANT TO
SECTION 2.3.1.
1.114
"VALID CLAIM" MEANS ANY CLAIM OF A PENDING PATENT
APPLICATION OR AN ISSUED UNEXPIRED PATENT THAT (A) HAS NOT BEEN FINALLY
CANCELLED, WITHDRAWN, ABANDONED OR REJECTED BY ANY ADMINISTRATIVE AGENCY OR
OTHER BODY OF COMPETENT JURISDICTION, (B) HAS NOT BEEN PERMANENTLY REVOKED, HELD
INVALID, OR DECLARED UNPATENTABLE OR UNENFORCEABLE IN A DECISION OF A COURT OR
OTHER BODY OF COMPETENT JURISDICTION THAT IS UNAPPEALABLE OR UNAPPEALED WITHIN
THE TIME ALLOWED FOR APPEAL, (C) HAS NOT BEEN RENDERED UNENFORCEABLE THROUGH
DISCLAIMER OR OTHERWISE, AND (D) IS NOT LOST THROUGH AN INTERFERENCE PROCEEDING.
1.115
"WAIVED COMPOUND" MEANS ON A TARGET-BY-TARGET BASIS,
(A) ANY COLLABORATION COMPOUND THAT DOES NOT SATISFY MINIMUM REQUIREMENT,
(B) ANY COLLABORATION COMPOUND FOR WHICH DS DOES NOT EXERCISE THE DS OPTION
PRIOR