LICENSED PRODUCT OR THE COMMERCIALIZATION OF A PARTICULAR LICENSED PRODUCT
(INCLUDING ANY CO-COMMERCIALIZED LICENSED PRODUCTS), THE EFFORTS AND RESOURCES
COMPARABLE TO THOSE UNDERTAKEN BY DS IN PURSUING INTELLECTUAL PROPERTY
PROTECTION AND DEVELOPMENT OF PRODUCT CANDIDATES AND COMMERCIALIZATION OF
PRODUCTS, AS APPLICABLE, THAT ARE NOT SUBJECT TO THE COLLABORATION AND THAT ARE
AT AN EQUIVALENT STAGE OF DEVELOPMENT OR COMMERCIALIZATION AND HAVE SIMILAR
MARKET POTENTIAL AND ARE AT A SIMILAR STAGE IN THEIR LIFECYCLE.
FOR PURPOSES OF
BOTH (A) AND (B) ABOVE, ALL RELEVANT FACTORS AS MEASURED BY THE FACTS AND
CIRCUMSTANCES AT THE TIME SUCH EFFORTS ARE DUE SHALL BE TAKEN INTO ACCOUNT,
INCLUDING, AS APPLICABLE AND WITHOUT LIMITATION, MECHANISM OF ACTION; EFFICACY
AND SAFETY; PRODUCT PROFILE; ACTUAL OR ANTICIPATED REGULATORY AUTHORITY APPROVED
LABELING; AND THE NATURE AND EXTENT OF MARKET EXCLUSIVITY (INCLUDING PATENT
COVERAGE, PROPRIETARY POSITION AND REGULATORY EXCLUSIVITY; COST, TIME REQUIRED
FOR AND LIKELIHOOD OF OBTAINING COMMERCIALIZATION REGULATORY APPROVAL;
COMPETITIVENESS OF ALTERNATIVE PRODUCTS AND MARKET CONDITIONS; ACTUAL OR
PROJECTED PROFITABILITY AND AVAILABILITY OF CAPACITY TO MANUFACTURE AND SUPPLY
FOR COMMERCIAL SALE).
1.32
"COMMERCIALIZATION REGULATORY APPROVAL" MEANS,
WITH RESPECT TO ANY LICENSED PRODUCT, THE REGULATORY APPROVAL REQUIRED BY
APPLICABLE LAWS TO SELL SUCH LICENSED PRODUCT FOR USE IN THE FIELD IN A COUNTRY
OR REGION IN THE TERRITORY.
"COMMERCIALIZATION REGULATORY APPROVAL" SHALL
INCLUDE, WITHOUT LIMITATION, THE APPROVAL OF ANY DRUG APPROVAL APPLICATION.
FOR
PURPOSES OF CLARITY, "COMMERCIALIZATION REGULATORY APPROVAL" IN THE UNITED
STATES SHALL MEAN FINAL APPROVAL OF AN NDA FOR THE FIRST INDICATION OR SNDA FOR
AN ADDITIONAL INDICATION PERMITTING MARKETING OF THE APPLICABLE LICENSED PRODUCT
IN INTERSTATE COMMERCE IN THE UNITED STATES, "COMMERCIALIZATION REGULATORY
APPROVAL" IN THE EUROPEAN UNION SHALL MEAN MARKETING AUTHORIZATION FOR THE
APPLICABLE LICENSED PRODUCT PURSUANT TO COUNCIL DIRECTIVE 2001/83/EC, AS
AMENDED, OR COUNCIL REGULATION 2309/93/EEC, AS AMENDED AND "COMMERCIALIZATION
REGULATORY APPROVAL" IN JAPAN SHALL MEAN FINAL APPROVAL OF AN APPLICATION
SUBMITTED TO THE MINISTRY OF HEALTH, LABOR AND WELFARE AND THE PUBLICATION OF A
NEW DRUG APPROVAL INFORMATION PACKAGE PERMITTING MARKETING OF THE APPLICABLE
LICENSED PRODUCT IN JAPAN, AS ANY OF THE FOREGOING MAY BE AMENDED FROM TIME TO
TIME.
7
1.33
"COMMITTEE" MEANS, COLLECTIVELY, THE JEC, THE JRC, AND THE USCC.
1.34
"COMPOUND" MEANS ANY KINASE INHIBITOR HAVING A MOLECULAR WEIGHT
LESS THAN *.
1.35
"CONFIDENTIAL INFORMATION" MEANS (A) WITH RESPECT TO ARQULE, ALL
TANGIBLE EMBODIMENTS OF ARQULE TECHNOLOGY, (B) WITH RESPECT TO DS, ALL TANGIBLE
EMBODIMENTS OF DS TECHNOLOGY AND (C) WITH RESPECT TO EACH PARTY, (I) ALL
TANGIBLE EMBODIMENTS OF JOINT TECHNOLOGY AND (II) ALL INFORMATION, TECHNOLOGY
AND PROPRIETARY MATERIALS DISCLOSED OR PROVIDED BY OR ON BEHALF OF SUCH PARTY
(THE "DISCLOSING PARTY") TO THE OTHER PARTY (THE "RECEIVING PARTY") OR TO ANY OF
THE RECEIVING PARTY'S EMPLOYEES, CONSULTANTS, AFFILIATES OR SUBLICENSEES (OR
SUBLICENSEES, AS THE CASE MAY BE); PROVIDED, THAT, NONE OF THE FOREGOING SHALL
BE CONFIDENTIAL INFORMATION IF: (A) AS OF THE DATE OF DISCLOSURE, IT IS KNOWN TO
THE RECEIVING PARTY OR ITS AFFILIATES AS DEMONSTRATED BY CONTEMPORANEOUS
CREDIBLE WRITTEN DOCUMENTATION, OTHER THAN BY VIRTUE OF