LICENSED PATENT RIGHTS IN THE ABSENCE OF A
MATERIAL BREACH OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION BY (A) FILING A
DECLARATORY JUDGMENT ACTION IN WHICH ANY OF THE LICENSED PATENT RIGHTS IS
ALLEGED TO BE INVALID OR UNENFORCEABLE; (B) CITING PRIOR ART PURSUANT TO 35
U.S.C. §301, FILING A REQUEST FOR RE-EXAMINATION OF ANY OF THE LICENSED PATENT
RIGHTS PURSUANT TO 35 U.S.C. §302 AND/OR §311, OR PROVOKING AN INTERFERENCE WITH
AN APPLICATION FOR ANY OF THE LICENSED PATENT RIGHTS PURSUANT TO 35 U.S.C. §135;
OR (C) FILING OR COMMENCING ANY RE-EXAMINATION, OPPOSITION, CANCELLATION,
NULLITY OR SIMILAR PROCEEDINGS AGAINST ANY OF THE LICENSED PATENT RIGHTS IN ANY
COUNTRY.
1.24
"CLINICAL TRIAL" MEANS, COLLECTIVELY, A PHASE I
CLINICAL TRIAL, PHASE II CLINICAL TRIAL OR PHASE III CLINICAL TRIAL.
1.25
"CO-COMMERCIALIZE" OR "CO-COMMERCIALIZATION
ACTIVITIES" MEANS WITH RESPECT TO ANY CO-COMMERCIALIZED LICENSED PRODUCT, THE
JOINT DETAILING OF SUCH CO-COMMERCIALIZED
5
LICENSED PRODUCT IN THE CO-COMMERCIALIZATION TERRITORY USING A COORDINATED SALES
FORCE CONSISTING OF REPRESENTATIVES OF BOTH PARTIES.
1.26
"CO-COMMERCIALIZATION OPTION PERIOD" MEANS, WITH
RESPECT TO EACH LICENSED PRODUCT, THE PERIOD COMMENCING ON THE DATE OF EXERCISE
BY DS OF THE DS OPTION AND THE GRANT OF THE EXCLUSIVE LICENSES WITH RESPECT TO
SUCH LICENSED PRODUCT AND CONTINUING UNTIL THE LATER OF (A) * (*) DAYS PRIOR TO
THE INITIATION OF THE FIRST PHASE III CLINICAL TRIAL WITH RESPECT TO THAT
LICENSED PRODUCT, OR (B) * (*) DAYS AFTER DS GIVES ARQULE A PHASE III NOTICE
PURSUANT TO SECTION4.10.2(A)(I).
1.27
"CO-COMMERCIALIZATION TERRITORY" MEANS THE UNITED
STATES.
1.28
"COLLABORATION" MEANS THE ALLIANCE OF ARQULE AND
DS ESTABLISHED PURSUANT TO THIS AGREEMENT FOR THE PURPOSES OF IDENTIFYING,
RESEARCHING AND DEVELOPING COLLABORATION COMPOUNDS AND COMMERCIALIZING LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY.
1.29
"COLLABORATION COMPOUND" MEANS ANY COMPOUND THAT
IS IDENTIFIED OR SYNTHESIZED BY EITHER PARTY IN THE CONDUCT OF THE RESEARCH
PROGRAM.
1.30
"COMMERCIALIZATION" OR "COMMERCIALIZE" MEANS ANY
AND ALL ACTIVITIES DIRECTED TO THE COMMERCIALIZATION OF A LICENSED PRODUCT UNDER
THE LICENSED PRODUCT TRADEMARKS SELECTED BY DS AFTER COMMERCIALIZATION
REGULATORY APPROVAL HAS BEEN OBTAINED, INCLUDING MARKETING, MANUFACTURING FOR
COMMERCIAL SALE, PROMOTING, DETAILING, DISTRIBUTING, OFFERING TO SELL AND
SELLING A LICENSED PRODUCT, IMPORTING A LICENSED PRODUCT FOR SALE, CONDUCTING
POST-MARKETING HUMAN CLINICAL STUDIES AND INTERACTING WITH REGULATORY
AUTHORITIES REGARDING THE FOREGOING.
WHEN USED AS A VERB, "TO COMMERCIALIZE"
AND "COMMERCIALIZING" MEANS TO ENGAGE IN COMMERCIALIZATION AND "COMMERCIALIZED"
HAS A CORRESPONDING MEANING.
1.31
"COMMERCIALLY REASONABLE EFFORTS" MEANS (A) WITH
RESPECT TO ACTIVITIES OF ARQULE IN THE RESEARCH PROGRAM AND/OR IN THE
COMMERCIALIZATION OF ANY CO-COMMERCIALIZED LICENSED PRODUCTS, THE EFFORTS AND
RESOURCES COMPARABLE TO THOSE UNDERTAKEN BY ARQULE IN PURSUING THE RESEARCH,
DISCOVERY OR COMMERCIALIZATION OF PROPRIETARY MATERIALS AND THE DEVELOPMENT OF
PRODUCT CANDIDATES, AS APPLICABLE, THAT ARE NOT SUBJECT TO THE COLLABORATION AND
THAT ARE AT AN EQUIVALENT STAGE OF DEVELOPMENT OR COMMERCIALIZATION AND HAVE
SIMILAR MARKET
6
POTENTIAL AND ARE AT A SIMILAR STAGE IN THEIR LIFECYCLE; AND (B) WITH RESPECT TO
ACTIVITIES OF DS IN THE RESEARCH PROGRAM, THE DEVELOPMENT OF A PARTICULAR