Exhibit 10.22

 

COLLABORATIVE RESEARCH, DEVELOPMENT

 

AND LICENSE AGREEMENT

 

between

 

ARQULE, INC.

 

and

 

DAIICHI SANKYO CO., LTD

 

November 7, 2008

 

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.  CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.  OMITTED TEXT IS INDICATED BY AN
“*”.

 

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TABLE OF CONTENTS

 

 

 

Page

 

 

 

1.

DEFINITIONS

1

 

 

 

2.

ADMINISTRATION OF THE COLLABORATION

23

 

 

 

2.1

Joint Executive Committee

23

2.2

Joint Research Committee

26

2.3

US Co-Commercialization Committee

29

2.4

Alliance Management

30

2.5

Interests of the Parties

30

2.6

Appointment Not an Obligation; No Breach

30

 

 

 

3.

RESEARCH PROGRAM

30

 

 

 

3.1

Objectives of the Research Program

30

3.2

Annual Research Plans

31

3.3

Conduct of Research Program

31

3.4

Records

33

3.5

Selection of DS Targets

34

3.6

Designation and Advancement of Collaboration Compounds

37

3.7

Supply of Collaboration Compounds

37

3.8

Supply of Proprietary Materials

38

3.9

Determination of IC50

38

3.10

Research Collaboration Period

38

 

 

 

4.

DEVELOPMENT PROGRAM; COMMERCIALIZATION OF LICENSED PRODUCTS

39

 

 

 

4.1

Objectives of the Development Program

39

4.2

Responsibility for Development and Commercialization of Licensed Products

39

4.3

Development Plans

39

4.4

Commercial Assessment

40

4.5

Licensed Product Commercialization Plans

40

4.6

Manufacture and Supply of Licensed Products

40

4.7

Development and Commercialization Diligence

41

4.8

Compliance

41

4.9

Exchange of Reports; Information; Updates

42

4.10

Development and Commercialization Rights and Restrictions

43

4.11

Expansion of the Field

46

 

 

 

5.

COMPENSATION

47

 

 

 

5.1

Upfront Fee

47

5.2

License Fee

47

5.3

Research Funding

47

5.4

Milestone and Royalty Payments

48

 

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6.

TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION

49

 

 

 

6.1

Confidentiality

49

6.2

Publicity

50

6.3

Publications and Presentations

51

6.4

AKIP Platform Technology

52

6.5

Prohibition on Solicitation

52

 

 

 

7.

LICENSE GRANTS; EXCLUSIVITY

52

 

 

 

7.1

DS Option

52

7.2

Research Licenses

54

7.3

Development Licenses

54

7.4

Commercialization License

55

7.5

Right to Sublicense

56

7.6

No Other Rights

56

7.7

Exclusivity

56

 

 

 

8.

INTELLECTUAL PROPERTY RIGHTS

57

 

 

 

8.1

ARQULE Intellectual Property Rights

57

8.2

DS Intellectual Property Rights

57

8.3

Joint Technology and Joint Patent Rights

58

8.4

Patent Coordinators

58

8.5

Inventorship

58

8.6

Cooperation

58

 

 

 

9.

FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

59

 

 

 

9.1

Patent Filing, Prosecution and Maintenance

59

9.2

Legal Actions

62

9.3

Trademark and Copyright Prosecution, Defense and Enforcement

66

 

 

 

10.

TERM AND TERMINATION

67

 

 

 

10.1

Term

67

10.2

Termination

67

10.3

Consequences of Termination of Agreement

68

10.4

Surviving Provisions

72

 

 

 

11.

REPRESENTATIONS AND WARRANTIES

73

 

 

 

11.1

Mutual Representations and Warranties

73

11.2

ARQULE’s Representations and Warranties

73

 

 

 

12.

INDEMNIFICATION

74

 

 

 

12.1

Indemnification of DS by ARQULE

74

12.2

Indemnification of ARQULE by DS

74

12.3

Conditions to Indemnification

75

12.4

Warranty Disclaimer

75

12.5

No Warranty of Success

75

12.6

Limited Liability

76

 

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13.

MISCELLANEOUS

76

 

 

 

13.1

Arbitration

76

13.2

Notices

78

13.3

Governing Law

79

13.4

Binding Effect

79

13.5

Headings

80

13.6

Counterparts

80

13.7

Amendment; Waiver

80

13.8

No Third Party Beneficiaries

80

13.9

Purposes and Scope

80

13.10

Assignment and Successors

80

13.11

Force Majeure

81

13.12

Interpretation

81

13.13

Integration; Severability

81

13.14

Further Assurances

81

 

List of Schedules

 

Schedule 1                                      Research Stages/Advancement
Criteria

Schedule 2                                      DS Target List

Schedule 3                                      Milestone and Royalty Provisions
to Be Negotiated pursuant to Section 5.4 and Included in License Agreements

 

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COLLABORATIVE RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT

 

This COLLABORATIVE RESEARCH DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”)
is entered into as of November 7, 2008, by and between ARQULE, Inc., a Delaware
corporation with offices at 19 Presidential Way, Woburn, MA 01801-5140
(“ARQULE”), and Daiichi Sankyo Co., Ltd, a Japanese company organized under the
laws of Japan with offices at 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426,
Japan (“DS”).  Each of DS and ARQULE is sometimes referred to individually
herein as a “Party” and collectively as the “Parties.”

 

WHEREAS, ARQULE has developed and controls certain proprietary technology and
know-how used for the discovery and development of therapeutics that inhibit
kinases; and

 

WHEREAS, DS has expertise in pharmaceutical research, development and
commercialization; and

 

WHEREAS, the Parties desire to enter into a collaboration for the purposes of
identifying kinase inhibitors for research, development and optimization and of
developing and commercializing products containing or derived from such
optimized kinase inhibitors.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the Parties hereto, intending to be
legally bound, hereby agree as follows:

 

1.                                      DEFINITIONS

 

Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article 1 shall have the meanings specified.

 

1.1                                 “AAA” MEANS THE AMERICAN ARBITRATION
ASSOCIATION.

 

1.2                                 “ABANDONED DS TARGET” MEANS ANY DS TARGET
WITH RESPECT TO WHICH DS DETERMINES, IN ITS SOLE DISCRETION, TO DISCONTINUE
FURTHER RESEARCH AS PART OF THE RESEARCH PROGRAM PURSUANT TO SECTION 3.5.2(A).

 

1

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1.3                                 “ADVANCEMENT” OR “ADVANCE” MEANS, WITH
RESPECT TO A COLLABORATION COMPOUND, THE DECISION BY THE JRC TO ADVANCE SUCH
COLLABORATION COMPOUND FROM ONE RESEARCH STAGE TO THE NEXT SUCCEEDING RESEARCH
STAGE.

 

1.4                                 “ADVANCEMENT CRITERIA” MEANS THE GUIDELINE
CRITERIA TO BE USED BY THE JRC IN ORDER TO ADVANCE A COLLABORATION COMPOUND
THROUGH EACH RESEARCH STAGE OF THE RESEARCH PROGRAM.  FOR PURPOSES OF CLARITY,
THE ADVANCEMENT CRITERIA AS OF THE EFFECTIVE DATE ARE SET FORTH IN SCHEDULE 1
ATTACHED HERETO, WHICH SCHEDULE 1 MAY BE AMENDED FROM TIME TO TIME BY THE
PARTIES.

 

1.5                                 “ADVERSE EVENT” MEANS ANY UNTOWARD,
UNDESIRED OR UNPLANNED MEDICAL OCCURRENCE IN A HUMAN CLINICAL TRIAL SUBJECT OR A
PATIENT, WHICH OCCURRENCE HAS A TEMPORAL RELATIONSHIP TO ADMINISTRATION OF A
LICENSED PRODUCT, WHETHER OR NOT CONSIDERED RELATED TO THE LICENSED PRODUCT,
INCLUDING, WITHOUT LIMITATION, ANY UNDESIRABLE SIGN (INCLUDING ABNORMAL
LABORATORY FINDINGS OF CLINICAL CONCERN), SYMPTOM OR DISEASE ASSOCIATED WITH THE
USE OF SUCH LICENSED PRODUCT.

 

1.6                                 “AFFILIATE” MEANS, WITH RESPECT TO ANY
PERSON, ANY OTHER PERSON THAT, DIRECTLY OR INDIRECTLY THROUGH ONE OR MORE
AFFILIATES, CONTROLS, OR IS CONTROLLED BY, OR IS UNDER COMMON CONTROL WITH, SUCH
PERSON.  FOR PURPOSES OF THIS DEFINITION, “CONTROL” MEANS (A) OWNERSHIP OF FIFTY
PERCENT (50%) OR MORE OF THE SHARES OF STOCK ENTITLED TO VOTE FOR THE ELECTION
OF DIRECTORS IN THE CASE OF A CORPORATION, OR FIFTY PERCENT (50%) OR MORE OF THE
EQUITY INTERESTS IN THE CASE OF ANY OTHER TYPE OF LEGAL ENTITY, (B) STATUS AS A
GENERAL PARTNER IN ANY PARTNERSHIP, OR (C) ANY OTHER ARRANGEMENT WHEREBY A
PERSON CONTROLS OR HAS THE RIGHT TO CONTROL THE BOARD OF DIRECTORS OF A
CORPORATION OR EQUIVALENT GOVERNING BODY OF AN ENTITY OTHER THAN A CORPORATION.

 

1.7                                 “AKIP PLATFORM TECHNOLOGY” MEANS BOTH
(A) THE PROPRIETARY TECHNOLOGY CONTROLLED BY ARQULE AND USED FOR THE
IDENTIFICATION AND DEVELOPMENT OF KINASE INHIBITORS AND (B) DATA AND INFORMATION
RELATING TO THE STRUCTURE AND MECHANISM OF INHIBITION OF KINASE INHIBITORS THAT
ARE IDENTIFIED THROUGH THE USE OF SUCH PROPRIETARY TECHNOLOGY.

 

1.8                                 “ANNUAL NET SALES” MEANS, WITH RESPECT TO
ANY CALENDAR YEAR, THE AGGREGATE AMOUNT OF THE NET SALES FOR SUCH CALENDAR YEAR.

 

2

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1.9                                 “ANNUAL RESEARCH PLAN” MEANS, WITH RESPECT
TO EACH DS TARGET, THE WRITTEN PLAN DESCRIBING THE RESEARCH ACTIVITIES TO BE
CARRIED OUT BY EACH PARTY FOR SUCH DS TARGET DURING THE RESEARCH COLLABORATION
PERIOD IN CONDUCTING EACH RESEARCH STAGE OF THE RESEARCH PROGRAM PURSUANT TO
THIS AGREEMENT, WHICH SHALL INCLUDE THE OBJECTIVES OF, AND THE ALLOCATION OF
RESOURCES (INCLUDING THE FTE FUNDING COMMITMENT) WITH RESPECT THERETO, AS SUCH
WRITTEN PLAN MAY BE AMENDED, MODIFIED OR UPDATED, AS FURTHER DESCRIBED IN
SECTION 3.2.

 

1.10                           “APPLICABLE LAWS” MEANS FEDERAL, STATE, LOCAL,
NATIONAL AND SUPRA-NATIONAL LAWS, STATUTES, RULES AND REGULATIONS, INCLUDING ANY
RULES, REGULATIONS, GUIDANCE, GUIDELINES OR REQUIREMENTS OF REGULATORY
AUTHORITIES, NATIONAL SECURITIES EXCHANGES OR SECURITIES LISTING ORGANIZATIONS,
THAT ARE IN EFFECT FROM TIME TO TIME DURING THE TERM AND APPLY TO A PARTICULAR
ACTIVITY HEREUNDER.

 

1.11                           “ARQULE BACKGROUND TECHNOLOGY” MEANS ANY
TECHNOLOGY THAT IS USED BY ARQULE, OR PROVIDED BY ARQULE FOR USE, IN THE
RESEARCH PROGRAM THAT IS (A) CONTROLLED BY ARQULE AS OF THE EFFECTIVE DATE OR
(B) CONCEIVED OR FIRST REDUCED TO PRACTICE BY EMPLOYEES OF, OR CONSULTANTS TO,
ARQULE AFTER THE EFFECTIVE DATE OTHER THAN IN THE CONDUCT OF ARQULE RESEARCH
ACTIVITIES AND WITHOUT THE USE IN ANY MATERIAL RESPECT OF ANY DS TECHNOLOGY, DS
PATENT RIGHTS OR DS MATERIALS.  FOR PURPOSES OF CLARITY, ARQULE BACKGROUND
TECHNOLOGY (A) SHALL INCLUDE THE AKIP PLATFORM TECHNOLOGY, AND (B) SHALL NOT
INCLUDE COLLABORATION COMPOUNDS, ARQULE PROGRAM TECHNOLOGY OR ARQULE’S INTEREST
IN JOINT TECHNOLOGY.

 

1.12                           “ARQULE DECISION” MEANS A DECISION WITH RESPECT
TO THE FOLLOWING ISSUES:  (A) THE APPLICATION BY ARQULE OF THE AKIP PLATFORM
TECHNOLOGY AGAINST *; (B) WHETHER * IS TO INCUR ANY *; (C) WHETHER * IS TO INCUR
ANY * IN THE PERFORMANCE OF * AND (D) THE DESIGNATION OF ANY *.

 

1.13                           “ARQULE MATERIALS” MEANS ANY PROPRIETARY
MATERIALS THAT ARE CONTROLLED BY ARQULE AND USED BY ARQULE, OR PROVIDED BY
ARQULE FOR USE, IN THE RESEARCH PROGRAM AND/OR THE DEVELOPMENT PROGRAM.  FOR
PURPOSES OF CLARITY, ARQULE MATERIALS SHALL INCLUDE ALL COMPOUNDS PROVIDED BY
ARQULE FOR USE IN THE RESEARCH PROGRAM.

 

3

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1.14                           “ARQULE PATENT RIGHTS” MEANS ANY PATENT RIGHTS
CONTROLLED BY ARQULE THAT CONTAIN ONE OR MORE CLAIMS THAT COVER ARQULE
TECHNOLOGY.

 

1.15                           “ARQULE PROGRAM TECHNOLOGY” MEANS (A) ANY PROGRAM
TECHNOLOGY THAT IS CONCEIVED OR FIRST REDUCED TO PRACTICE BY EMPLOYEES OF, OR
CONSULTANTS TO, ARQULE, ALONE OR JOINTLY WITH ANY THIRD PARTY, WITHOUT THE USE
IN ANY MATERIAL RESPECT OF ANY DS TECHNOLOGY, DS PATENT RIGHTS, DS MATERIALS OR
JOINT TECHNOLOGY; (B) ANY PROGRAM TECHNOLOGY, REGARDLESS OF WHETHER CONCEIVED OR
FIRST REDUCED TO PRACTICE BY EMPLOYEES OF, OR CONSULTANTS TO, ARQULE, DS, OR
BOTH PARTIES, ALONE OR JOINTLY WITH ANY THIRD PARTY, THAT RELATES TO, OR
CONSTITUTES, AKIP PLATFORM TECHNOLOGY, AND (C) ALL COLLABORATION COMPOUNDS.

 

1.16                           “ARQULE RESEARCH ACTIVITIES” MEANS ALL ACTIVITIES
SPECIFIED TO BE CONDUCTED BY ARQULE IN ANY ANNUAL RESEARCH PLAN (OR AMENDMENT
THERETO) THAT ARE (A) APPROVED BY THE JRC AND (B) TO THE EXTENT INVOLVING
MATTERS THAT ARE ARQULE DECISIONS, APPROVED BY ARQULE IN ACCORDANCE WITH
SECTION 2.1.5.  FOR PURPOSES OF CLARITY, UNLESS OTHERWISE SET FORTH IN ANY
ANNUAL RESEARCH PLAN, ARQULE RESEARCH ACTIVITIES SHALL INCLUDE (A) ALL
FEASIBILITY ASSESSMENT ACTIVITIES AND (B) ALL ASSAY DEVELOPMENT AND HIT
GENERATION ACTIVITIES AND HIT TO LEAD ACTIVITIES TO BE CONDUCTED AS PART OF THE
RESEARCH PROGRAM.

 

1.17                           “ARQULE TECHNOLOGY” MEANS, COLLECTIVELY, ARQULE
BACKGROUND TECHNOLOGY AND ARQULE PROGRAM TECHNOLOGY.

 

1.18                           “BACKUP COMPOUND” MEANS, WITH RESPECT TO ANY
PRIMARY DEVELOPMENT COMPOUND, ANY OTHER COLLABORATION COMPOUND THAT IS
DESIGNATED BY DS AT ANY TIME BEFORE THE EXPIRATION OF THE DS OPTION PERIOD FOR
THE DS TARGET OF SUCH PRIMARY DEVELOPMENT COMPOUND, THAT (A) HAS THE SAME DS
TARGET AS SUCH PRIMARY DEVELOPMENT COMPOUND, AND (B) SATISFIES MINIMUM
REQUIREMENT; PROVIDED, THAT, NO COLLABORATION COMPOUND SHALL, AFTER BECOMING A
WAIVED COMPOUND OR TERMINATED COMPOUND, BE DESIGNATED BY DS AS A BACKUP
COMPOUND.

 

1.19                           “BLOCKED TARGET” MEANS ANY TARGET LISTED ON THE
BLOCKED TARGET LIST THAT MAY NOT BE DESIGNATED AS A DS TARGET UNDER THIS
AGREEMENT.  FOR PURPOSES OF CLARITY, A TARGET MAY ONLY BE DESIGNATED BY ARQULE
AS A BLOCKED TARGET IF (A) *, (B) *

 

4

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WITH RESPECT TO A LICENSE, COLLABORATION OR SIMILAR AGREEMENT RELATING TO
COMPOUNDS AGAINST SUCH TARGET, OR (C) *.

 

1.20                           “BUSINESS DAY” MEANS ANY DAY ON WHICH BANKING
INSTITUTIONS IN TOKYO ARE OPEN FOR BUSINESS.

 

1.21                           “CALENDAR QUARTER” MEANS EACH SUCCESSIVE PERIOD
OF THREE (3) CONSECUTIVE CALENDAR MONTHS COMMENCING ON JANUARY 1, APRIL 1,
JULY 1 OR OCTOBER 1, AS THE CASE MAY BE, AND ENDING ON MARCH 31, JUNE 30,
SEPTEMBER 30 OR DECEMBER 31, RESPECTIVELY; PROVIDED, THAT, THE INITIAL CALENDAR
QUARTER SHALL COMMENCE ON THE EFFECTIVE DATE AND END ON DECEMBER 31, 2008 AND
THE FINAL CALENDAR QUARTER SHALL END ON THE APPROPRIATE ANNIVERSARY OF THE
EFFECTIVE DATE.

 

1.22                           “CALENDAR YEAR” MEANS EACH SUCCESSIVE PERIOD OF
TWELVE (12) MONTHS COMMENCING ON JANUARY 1 AND ENDING ON DECEMBER 31.

 

1.23                           “CHALLENGE” MEANS ANY CHALLENGE TO THE VALIDITY
OR ENFORCEABILITY OF ANY OF THE 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

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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

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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
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.

 

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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 A PRIOR CONFIDENTIAL
DISCLOSURE TO SUCH RECEIVING PARTY; (B) AS OF THE DATE OF DISCLOSURE IT IS IN
THE PUBLIC DOMAIN, OR IT SUBSEQUENTLY ENTERS THE PUBLIC DOMAIN THROUGH NO FAULT
OF THE RECEIVING PARTY; (C) IT IS OBTAINED BY THE RECEIVING PARTY FROM A THIRD
PARTY HAVING A LAWFUL RIGHT TO MAKE SUCH DISCLOSURE FREE FROM ANY OBLIGATION OF
CONFIDENTIALITY TO THE DISCLOSING PARTY; OR (D) IT IS INDEPENDENTLY DEVELOPED BY
OR FOR THE RECEIVING PARTY WITHOUT REFERENCE TO OR USE OF ANY CONFIDENTIAL
INFORMATION OF THE DISCLOSING PARTY AS DEMONSTRATED BY CONTEMPORANEOUS CREDIBLE
WRITTEN DOCUMENTATION.  FOR PURPOSES OF CLARITY, UNLESS EXCLUDED FROM
CONFIDENTIAL INFORMATION PURSUANT TO THE PROVISO AT THE END OF THE PRECEDING
SENTENCE, ANY SCIENTIFIC, TECHNICAL OR FINANCIAL INFORMATION OF A PARTY THAT IS
DISCLOSED AT ANY MEETING OF ANY COMMITTEE OR DISCLOSED THROUGH AN AUDIT REPORT
SHALL CONSTITUTE CONFIDENTIAL INFORMATION OF THE DISCLOSING PARTY.  SUBJECT TO
THE RIGHTS OF THE PARTIES TO MAKE DISCLOSURES AS SET FORTH IN ARTICLE 6, THE
TERMS OF THIS AGREEMENT SHALL CONSTITUTE CONFIDENTIAL INFORMATION OF EACH PARTY.

 

1.36         “CONTRACT YEAR” MEANS (A) THE PERIOD BEGINNING ON THE EFFECTIVE
DATE AND ENDING ON THE FIRST ANNIVERSARY OF THE LAST DAY OF THE CALENDAR MONTH
IN WHICH THE EFFECTIVE DATE FALLS AND (B) EACH SUCCEEDING TWELVE (12) MONTH
PERIOD THEREAFTER.

 

1.37         “CONTROL” OR “CONTROLLED” MEANS (A) WITH RESPECT TO TECHNOLOGY OR
PATENT RIGHTS, THE POSSESSION BY A PARTY OF THE RIGHT TO GRANT A LICENSE OR
SUBLICENSE TO SUCH TECHNOLOGY

 

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OR PATENT RIGHTS AS PROVIDED HEREIN WITHOUT THE PAYMENT OF ADDITIONAL
CONSIDERATION TO, AND WITHOUT VIOLATING THE TERMS OF ANY AGREEMENT OR
ARRANGEMENT WITH, ANY THIRD PARTY AND WITHOUT VIOLATING ANY APPLICABLE LAWS AND
(B) WITH RESPECT TO PROPRIETARY MATERIALS, THE POSSESSION BY A PARTY OF THE
RIGHT TO SUPPLY SUCH PROPRIETARY MATERIALS TO THE OTHER PARTY AS PROVIDED HEREIN
WITHOUT THE PAYMENT OF ADDITIONAL CONSIDERATION TO, AND WITHOUT VIOLATING THE
TERMS OF, ANY AGREEMENT OR ARRANGEMENT WITH ANY THIRD PARTY, AND WITHOUT
VIOLATING ANY APPLICABLE LAWS.

 

1.38         “CTN” MEANS THE NOTIFICATION SUBMITTED TO THE JAPANESE MINISTRY OF
HEALTH, LABOR AND WELFARE PRIOR TO THE INITIATION OF A CLINICAL TRIAL IN JAPAN.

 

1.39         “DERIVED” MEANS IDENTIFIED, OBTAINED, DEVELOPED, CREATED,
SYNTHESIZED, GENERATED, DESIGNED OR RESULTING FROM, BASED UPON, CONTAINING OR
INCORPORATING; CONJUGATED TO OR COMPLEXED WITH (WHETHER DIRECTLY OR INDIRECTLY,
OR IN WHOLE OR IN PART).

 

1.40         “DETAIL” MEANS, WITH RESPECT TO A CO-COMMERCIALIZED LICENSED
PRODUCT, AN INTERACTIVE, LIVE, FACE-TO-FACE CONTACT OF A REPRESENTATIVE WITHIN
THE CO-COMMERCIALIZATION TERRITORY WITH A MEDICAL PROFESSIONAL WITH PRESCRIBING
AUTHORITY OR OTHER INDIVIDUALS OR ENTITIES THAT HAVE A SIGNIFICANT IMPACT OR
INFLUENCE ON PRESCRIBING DECISIONS, IN AN EFFORT TO INCREASE PHYSICIAN
PRESCRIBING PREFERENCES OF SUCH CO-COMMERCIALIZED LICENSED PRODUCT FOR ITS
APPROVED USES WITHIN THE CO-COMMERCIALIZATION TERRITORY.  WHEN USED AS A VERB,
“DETAILING” MEANS PERFORMING DETAILS.  WHEN USED AS AN ADJECTIVE, “DETAILING”
MEANS OF OR RELATED TO PERFORMING DETAILS.

 

1.41         “DEVELOPMENT” OR “DEVELOP” MEANS, WITH RESPECT TO EACH PRIMARY
DEVELOPMENT COMPOUND AND/OR BACKUP COMPOUND AND LICENSED PRODUCT (INCLUDING
WITHOUT LIMITATION ANY CO-COMMERCIALIZED LICENSED PRODUCT), ALL NON-CLINICAL AND
CLINICAL ACTIVITIES PERFORMED IN ORDER TO OBTAIN REGULATORY APPROVAL OF A
LICENSED PRODUCT (INCLUDING WITHOUT LIMITATION ANY CO-COMMERCIALIZED LICENSED
PRODUCT) IN ACCORDANCE WITH THIS AGREEMENT UP TO AND INCLUDING THE OBTAINING OF
COMMERCIALIZATION REGULATORY APPROVAL OF SUCH LICENSED PRODUCT.  FOR PURPOSES OF
CLARITY, THESE ACTIVITIES INCLUDE, WITHOUT LIMITATION, IN VIVO ANIMAL EFFICACY
TESTING, PRECLINICAL SAFETY TESTING, TEST METHOD DEVELOPMENT AND STABILITY
TESTING, REGULATORY TOXICOLOGY STUDIES, FORMULATION, PROCESS DEVELOPMENT,
MANUFACTURING, MANUFACTURING SCALE-UP, DEVELOPMENT-STAGE MANUFACTURING, QUALITY
ASSURANCE/QUALITY CONTROL DEVELOPMENT, STATISTICAL ANALYSIS AND REPORT

 

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WRITING, CLINICAL TRIAL DESIGN AND OPERATIONS, CONDUCTING CLINICAL TRIALS,
PREPARING AND FILING DRUG APPROVAL APPLICATIONS, AND ALL REGULATORY AFFAIRS
RELATED TO THE FOREGOING.  WHEN USED AS A VERB, “DEVELOPING” MEANS TO ENGAGE IN
DEVELOPMENT AND “DEVELOPED” HAS A CORRESPONDING MEANING.

 

1.42         “DEVELOPMENT PROGRAM” MEANS THE DEVELOPMENT ACTIVITIES TO BE
CONDUCTED DURING THE TERM WITH RESPECT TO EACH PRIMARY DEVELOPMENT COMPOUND
AND/OR BACKUP COMPOUND AND LICENSED PRODUCT (INCLUDING WITHOUT LIMITATION
CO-COMMERCIALIZED LICENSED PRODUCTS), WITH THE OBJECTIVE OF DEVELOPING SUCH
PRIMARY DEVELOPMENT COMPOUND AND/OR BACKUP COMPOUND AND LICENSED PRODUCT.

 

1.43         “DRUG APPROVAL APPLICATION” MEANS, WITH RESPECT TO A LICENSED
PRODUCT IN A PARTICULAR COUNTRY OR REGION, AN APPLICATION FOR COMMERCIALIZATION
REGULATORY APPROVAL FOR SUCH LICENSED PRODUCT IN SUCH COUNTRY OR REGION,
INCLUDING WITHOUT LIMITATION: (A) AN NDA OR SNDA; (B) A COUNTERPART OF AN NDA OR
SNDA IN ANY COUNTRY OR REGION IN THE TERRITORY (INCLUDING, WITHOUT LIMITATION, A
CTN); AND (C) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE FOREGOING.

 

1.44         “DS BACKGROUND TECHNOLOGY” MEANS ANY TECHNOLOGY THAT IS USED BY DS,
OR PROVIDED BY DS FOR USE, IN THE RESEARCH PROGRAM AND/OR DEVELOPMENT PROGRAM
THAT IS (A) CONTROLLED BY DS AS OF THE EFFECTIVE DATE OR (B) CONCEIVED OR FIRST
REDUCED TO PRACTICE BY EMPLOYEES OF, OR CONSULTANTS TO, DS AFTER THE EFFECTIVE
DATE OTHER THAN IN THE CONDUCT OF DS RESEARCH ACTIVITIES OR DS DEVELOPMENT
ACTIVITIES AND WITHOUT THE USE IN ANY MATERIAL RESPECT OF ANY COLLABORATION
COMPOUNDS, ARQULE TECHNOLOGY, ARQULE PATENT RIGHTS, OR ARQULE MATERIALS.  FOR
PURPOSES OF CLARITY, DS BACKGROUND TECHNOLOGY SHALL NOT INCLUDE DS PROGRAM
TECHNOLOGY OR DS’S INTEREST IN JOINT TECHNOLOGY.

 

1.45         “DS DECISION” MEANS *.

 

1.46         “DS DEVELOPMENT ACTIVITIES” MEANS ALL DEVELOPMENT ACTIVITIES
(INCLUDING WITHOUT LIMITATION ALL DEVELOPMENT ACTIVITIES CONDUCTED WITH RESPECT
TO CO-COMMERCIALIZED COLLABORATION COMPOUNDS) SPECIFIED TO BE CONDUCTED BY DS.

 

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1.47         “DS MATERIALS” MEANS ANY PROPRIETARY MATERIALS THAT ARE CONTROLLED
BY DS AND USED BY DS, OR PROVIDED BY DS FOR USE, IN THE RESEARCH PROGRAM AND/OR
THE DEVELOPMENT PROGRAM.

 

1.48         “DS OPTION PERIOD” MEANS, WITH RESPECT TO ANY PRIMARY DEVELOPMENT
COMPOUND AND THE RELATED BACKUP COMPOUNDS, THE PERIOD COMMENCING ON THE DATE OF
DESIGNATION BY DS OF A PRIMARY DEVELOPMENT COMPOUND, AND CONTINUING UNTIL * (*)
DAYS FOLLOWING THE DATE OF RECEIPT BY THE JRC OF THE TOXICOLOGY STUDIES RESULTS
WITH RESPECT TO SUCH PRIMARY DEVELOPMENT COMPOUND, OR UP TO * (*) SUBSEQUENTLY
EVALUATED BACKUP COMPOUNDS PROVIDED THAT DS HAS DESIGNATED SUCH BACKUP COMPOUNDS
PRIOR TO THE START OF THE FIRST TOXICOLOGY STUDY; PROVIDED THAT THE DS OPTION
PERIOD SHALL END NO LATER THAN * (*) MONTHS AFTER THE END OF THE RESEARCH
COLLABORATION PERIOD.

 

1.49         “DS PATENT RIGHTS” MEANS ANY PATENT RIGHTS CONTROLLED BY DS THAT
CONTAIN ONE OR MORE CLAIMS THAT COVER DS TECHNOLOGY.

 

1.50         “DS PROGRAM TECHNOLOGY” MEANS ANY PROGRAM TECHNOLOGY THAT (A) IS
NOT ARQULE PROGRAM TECHNOLOGY OR JOINT TECHNOLOGY AND (B) IS CONCEIVED OR FIRST
REDUCED TO PRACTICE BY EMPLOYEES OF, OR CONSULTANTS TO, DS, ALONE OR JOINTLY
WITH ANY THIRD PARTY, WITHOUT THE USE IN ANY MATERIAL RESPECT OF ANY ARQULE
TECHNOLOGY, ARQULE PATENT RIGHTS, ARQULE MATERIALS OR JOINT TECHNOLOGY.

 

1.51         “DS RESEARCH ACTIVITIES” MEANS ALL ACTIVITIES SPECIFIED TO BE
CONDUCTED BY DS IN ANY ANNUAL RESEARCH PLAN (OR AMENDMENT THERETO) THAT ARE
APPROVED BY THE JEC.

 

1.52         “DS TARGET” MEANS EACH TARGET LISTED ON THE DS TARGET LIST, AS
AMENDED FROM TIME TO TIME IN ACCORDANCE WITH SECTION 3.5.2.

 

1.53         “DS TARGET LIST” MEANS THE LIST OF TARGETS LISTED ON SCHEDULE 2
ATTACHED HERETO AND INCORPORATED HEREIN BY REFERENCE.

 

1.54         “DS TECHNOLOGY” MEANS, COLLECTIVELY, DS BACKGROUND TECHNOLOGY AND
DS PROGRAM TECHNOLOGY.

 

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1.55         “EFFECTIVE DATE” MEANS THE DATE FIRST SET FORTH ABOVE.

 

1.56         “EUROPEAN UNION” OR “EU” MEANS THE COUNTRIES OF THE EUROPEAN UNION,
AS THE EUROPEAN UNION IS CONSTITUTED AS OF THE EFFECTIVE DATE AND AS IT MAY BE
EXPANDED FROM TIME TO TIME.

 

1.57         “FDA” MEANS THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR ANY
SUCCESSOR AGENCY OR AUTHORITY THERETO.

 

1.58         “FDCA” MEANS THE UNITED STATES FEDERAL FOOD, DRUG, AND COSMETIC
ACT, AS AMENDED.

 

1.59         “FEASIBILITY ASSESSMENT ACTIVITIES” MEANS THE ACTIVITIES TO BE
CONDUCTED BY ARQULE WITH RESPECT TO AVAILABLE TARGETS IN ORDER TO IDENTIFY THOSE
AVAILABLE TARGETS THAT ARQULE REASONABLY BELIEVES WOULD BE AMENABLE TO THE
APPLICATION OF THE AKIP PLATFORM TECHNOLOGY.

 

1.60         “FIELD” MEANS THE PREVENTION, TREATMENT, CURE AND/OR DELAY OF THE
ONSET OR PROGRESSION OF ALL HUMAN ONCOLOGY INDICATIONS.

 

1.61         “FIRST COMMERCIAL SALE” MEANS, WITH RESPECT TO A LICENSED PRODUCT
IN A COUNTRY IN THE TERRITORY, THE FIRST SALE, TRANSFER OR DISPOSITION FOR VALUE
OR FOR AN END USER OF SUCH LICENSED PRODUCT IN SUCH COUNTRY.  FOR PURPOSES OF
CLARITY, THE USE OF ANY LICENSED PRODUCT IN CLINICAL TRIALS, PRE-CLINICAL
STUDIES OR OTHER RESEARCH OR DEVELOPMENT ACTIVITIES, OR THE DISPOSAL OR TRANSFER
OF LICENSED PRODUCTS FOR A BONA FIDE CHARITABLE PURPOSE OR A COMMERCIALLY
REASONABLE SAMPLING PROGRAM, SHALL NOT BE DEEMED TO BE A SALE, TRANSFER OR
DISPOSITION FOR VALUE OR FOR AN END USER.

 

1.62         “FORCE MAJEURE” MEANS ANY OCCURRENCE BEYOND THE REASONABLE CONTROL
OF A PARTY THAT (A) PREVENTS OR SUBSTANTIALLY INTERFERES WITH THE PERFORMANCE BY
SUCH PARTY OF ANY OF ITS OBLIGATIONS HEREUNDER AND (B) OCCURS BY REASON OF ANY
ACT OF GOD, FLOOD, FIRE, EXPLOSION, EARTHQUAKE, STRIKE, LOCKOUT, LABOR DISPUTE,
CASUALTY OR ACCIDENT, OR WAR, REVOLUTION, CIVIL COMMOTION, ACT OF TERRORISM,
BLOCKAGE OR EMBARGO, OR ANY INJUNCTION, LAW, ORDER, PROCLAMATION, REGULATION,
ORDINANCE, DEMAND OR REQUIREMENT OF ANY GOVERNMENT OR OF ANY SUBDIVISION,
AUTHORITY OR REPRESENTATIVE OF ANY SUCH GOVERNMENT.

 

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1.63         “FTE” SHALL MEAN THE EFFORTS OF ONE FULL-TIME EMPLOYEE (OR
EQUIVALENT PART-TIME EFFORTS OF MORE THAN ONE EMPLOYEE) DEVOTED TO OR IN SUPPORT
OF THE ARQULE RESEARCH ACTIVITIES.

 

1.64         “FTE FUNDING COMMITMENT” MEANS (A) WITH RESPECT TO THE ARQULE
RESEARCH ACTIVITIES CONDUCTED IN THE FIRST CONTRACT YEAR DURING THE RESEARCH
COLLABORATION PERIOD, THE FUNDING OF * ARQULE FTES AT THE FTE RATE; AND (B) WITH
RESPECT TO THE ARQULE RESEARCH ACTIVITIES CONDUCTED BY ARQULE IN ANY SUBSEQUENT
CONTRACT YEAR DURING THE RESEARCH COLLABORATION PERIOD, THE FUNDING OF THAT
NUMBER OF FTES AS SHALL BE CONSISTENT WITH THE ANNUAL RESEARCH PLAN FOR SUCH
SUBSEQUENT CONTRACT YEAR AND AGREED TO BY THE PARTIES NOT LATER THAN * (*) DAYS
PRIOR TO THE COMMENCEMENT OF SUCH CONTRACT YEAR; PROVIDED, THAT, (I) DS SHALL
HAVE THE RIGHT TO REDUCE THE FTE FUNDING COMMITMENT IN ANY SUBSEQUENT CONTRACT
YEAR TO THE FUNDING AT THE FTE RATE OF A NUMBER OF FTES NO FEWER THAN * OF FTE
FUNDING COMMITMENT THAT IS APPLICABLE TO THE PREVIOUS CONTRACT YEAR, AND
(II) ARQULE’S CONSENT SHALL BE REQUIRED TO INCREASE THE NUMBER OF FTES ABOVE THE
NUMBER IN THE PREVIOUS YEAR. IN THE EVENT THE PARTIES CANNOT AGREE ON THE NUMBER
OF FTE’S IN ANY SUBSEQUENT YEAR, EACH PARTY SHALL GIVE WRITTEN NOTICE TO THE JEC
OF THE NUMBER OF  FTES IT BELIEVES ARE NEEDED TO PERFORM THE ARQULE RESEARCH
ACTIVITIES IN SUCH CONTRACT YEAR AND THE NUMBER OF FTES SHALL BE DECIDED IN
ACCORDANCE WITH SECTION 2.1.5.  UNTIL THE NUMBER OF FTES IS DECIDED,  THE FTE
FUNDING COMMITMENT FOR SUCH CONTRACT YEAR SHALL BE THE FUNDING AT THE FTE RATE
OF A NUMBER OF FTES EQUAL TO ONE HALF OF THE NUMBER OF FTES FUNDED IN THE
PREVIOUS YEAR.

 

1.65         “FTE RATE” MEANS WITH RESPECT TO THE CONDUCT BY ARQULE OF ARQULE
RESEARCH ACTIVITIES AND FEASIBILITY ASSESSMENT ACTIVITIES, * DOLLARS (US $*) PER
YEAR.  THE FTE RATE INCLUDES ALL SALARY, EMPLOYEE BENEFITS, MATERIALS AND ALL
OTHER EXPENSES INCLUDING SUPPORT STAFF AND OVERHEAD FOR OR ASSOCIATED WITH THE
SCIENTISTS OF A PARTY PERFORMING ACTIVITIES BUT DOES NOT INCLUDE THIRD PARTY
COSTS.

 

1.66         “HATCH-WAXMAN ACT” MEANS THE DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, AS AMENDED.

 

1.67         “IND” MEANS: (A) AN INVESTIGATIONAL NEW DRUG APPLICATION AS DEFINED
IN THE FDCA AND REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION
OR PROCEDURE

 

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REQUIRED TO INITIATE CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN THE
UNITED STATES; (B) A COUNTERPART OF AN INVESTIGATIONAL NEW DRUG APPLICATION THAT
IS REQUIRED IN ANY OTHER COUNTRY OR REGION IN THE TERRITORY BEFORE BEGINNING
CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN SUCH COUNTRY OR REGION; AND
(C) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE FOREGOING.

 

1.68         “INDICATION” MEANS ANY HUMAN INDICATION, DISEASE OR CONDITION WHICH
CAN BE TREATED, PREVENTED, CURED OR THE ONSET OR PROGRESSION OF WHICH CAN BE
DELAYED.  FOR PURPOSES OF CLARITY, DISTINCTIONS BETWEEN HUMAN INDICATIONS,
DISEASES OR CONDITIONS WITH RESPECT TO A LICENSED PRODUCT SHALL BE MADE BY
REFERENCE TO THE WORLD HEALTH ORGANIZATION INTERNATIONAL CLASSIFICATION OF
DISEASES, VERSION 10 (AS REVISED AND UPDATED, “ICD10”).

 

1.69         “INITIATION” OR “INITIATE” MEANS, WITH RESPECT TO A HUMAN CLINICAL
TRIAL, THE FIRST DATE THAT A SUBJECT OR PATIENT IS DOSED IN SUCH CLINICAL TRIAL.

 

1.70         “JOINT EXECUTIVE COMMITTEE” OR “JEC” MEANS THE COMMITTEE COMPOSED
OF ARQULE AND DS REPRESENTATIVES ESTABLISHED PURSUANT TO SECTION 2.1.1.

 

1.71         “JOINT PATENT RIGHTS” MEANS PATENT RIGHTS THAT CONTAIN ONE OR MORE
CLAIMS THAT COVER JOINT TECHNOLOGY.

 

1.72         “JOINT RESEARCH COMMITTEE” OR “JRC” MEANS THE COMMITTEE COMPOSED OF
ARQULE AND DS REPRESENTATIVES ESTABLISHED PURSUANT TO SECTION 2.2.

 

1.73         “JOINT TECHNOLOGY” MEANS ANY PROGRAM TECHNOLOGY THAT IS (A) JOINTLY
CONCEIVED OR REDUCED TO PRACTICE BY BOTH (I) EMPLOYEES OF, OR CONSULTANTS TO, DS
AND (II) EMPLOYEES OF OR CONSULTANTS TO ARQULE OR (B) CONCEIVED OR REDUCED TO
PRACTICE SOLELY BY EMPLOYEES OF, OR CONSULTANTS TO, A PARTY WITH THE USE IN ANY
MATERIAL RESPECT OF ANY TECHNOLOGY, PATENT RIGHTS OR PROPRIETARY MATERIALS OF
THE OTHER PARTY.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY,
ANY PROGRAM TECHNOLOGY THAT RELATES TO THE AKIP PLATFORM TECHNOLOGY SHALL NOT BE
CONSIDERED JOINT TECHNOLOGY IRRESPECTIVE OF WHICH PARTY OR PARTIES CONCEIVED OR
REDUCED TO PRACTICE SUCH PROGRAM TECHNOLOGY AND SHALL BE ARQULE PROGRAM
TECHNOLOGY.

 

1.74         “KINASE INHIBITION ASSAYS” MEANS THE RELEVANT ASSAYS USED TO
DETERMINE THE IC50 OF A COLLABORATION COMPOUND AGAINST A TARGET, WHICH SHALL
CONSIST OF ENZYMATIC ASSAYS OR

 

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BIOPHYSICAL METHODS AND ANY OTHER ASSAYS AGREED BY THE JRC AND SET FORTH IN THE
ANNUAL RESEARCH PLAN.

 

1.75         “LICENSED PATENT RIGHTS” MEANS ANY ARQULE PATENT RIGHTS AND
ARQULE’S INTEREST IN JOINT PATENT RIGHTS THAT (A) CONTAIN ONE OR MORE CLAIMS
THAT COVER ANY COLLABORATION COMPOUND OR LICENSED PRODUCT, INCLUDING ITS
MANUFACTURE OR ITS FORMULATION OR A METHOD OF ITS DELIVERY OR OF ITS USE, OR
(B) ARE NECESSARY OR USEFUL FOR DS TO EXERCISE THE LICENSES GRANTED TO IT
HEREUNDER.

 

1.76         “LICENSED PRODUCT” MEANS ANY PHARMACEUTICAL OR MEDICINAL ITEM,
SUBSTANCE OR FORMULATION THAT CONTAINS, INCORPORATES, COMPRISES OR IS DERIVED
FROM A PRIMARY DEVELOPMENT COMPOUND FOR WHICH DS HAS EXERCISED THE DS OPTION
UNDER SECTION 7.1.2 OR ANY BACKUP COMPOUND WITH RESPECT TO SUCH PRIMARY
DEVELOPMENT COMPOUND ; PROVIDED, THAT, NO PRIMARY DEVELOPMENT COMPOUND OR BACKUP
COMPOUND SHALL, AFTER BECOMING A WAIVED COMPOUND OR TERMINATED COMPOUND, BE
DEEMED TO BE A LICENSED PRODUCT.

 

1.77         “LICENSED PRODUCT COMMERCIALIZATION PLAN” MEANS, WITH RESPECT TO
EACH LICENSED PRODUCT (INCLUDING WITHOUT LIMITATION ANY CO-COMMERCIALIZED
LICENSED PRODUCT), THE WRITTEN PLAN FOR THE COMMERCIALIZATION OF SUCH LICENSED
PRODUCT IN THE TERRITORY, AS SUCH PLAN MAY BE AMENDED OR UPDATED.

 

1.78         “LICENSED PRODUCT TRADEMARK” MEANS ANY TRADEMARK OR TRADE NAME,
WHETHER OR NOT REGISTERED, OR ANY TRADEMARK APPLICATION OR RENEWAL, EXTENSION OR
MODIFICATION THEREOF, IN THE TERRITORY, OR ANY TRADE DRESS AND PACKAGING, IN
EACH CASE THAT ARE APPLIED TO OR USED WITH ANY LICENSED PRODUCT BY DS, TOGETHER
WITH ALL GOODWILL ASSOCIATED THEREWITH AND PROMOTIONAL MATERIALS RELATING
THERETO.

 

1.79         “LICENSED TECHNOLOGY” MEANS ANY ARQULE TECHNOLOGY AND ARQULE’S
INTEREST IN JOINT TECHNOLOGY THAT (A) RELATES TO ANY COLLABORATION COMPOUND OR
LICENSED PRODUCT, INCLUDING ITS MANUFACTURE OR ITS FORMULATION OR A METHOD OF
ITS DELIVERY OR OF ITS USE; AND (B) IS NECESSARY OR USEFUL FOR DS TO EXERCISE
THE LICENSES GRANTED TO IT HEREUNDER.

 

1.80         “MINIMUM REQUIREMENT” FOR A COLLABORATION COMPOUND MEANS (I) AN
IC50 LESS THAN *ΜM AGAINST A DS TARGET IN THE KINASE INHIBITION ASSAYS, (II) AN
IC50 AGAINST SUCH DS

 

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TARGET THAT IS LESS THAN *% OF THE IC50 AGAINST ANY OTHER TARGET IN THE TARGET
SPECIFICITY PANEL IN THE KINASE INHIBITION ASSAYS, AND (III) SATISFACTION OF THE
ADVANCEMENT CRITERIA TO ADVANCE FROM HIT TO LEAD TO LEAD OPTIMIZATION.

 

1.81         “NDA” MEANS A NEW DRUG APPLICATION, AS DEFINED IN THE FDCA AND
REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION OR PROCEDURE
REQUIRED TO SELL A LICENSED PRODUCT IN THE UNITED STATES.

 

1.82         “NET SALES” MEANS SUCH MEANING TO BE DEFINED IN THE AMENDMENT TO
THIS AGREEMENT OR SEPARATE AGREEMENT AS SET FORTH IN SECTION 5.4.

 

1.83         “PATENT RIGHTS” MEANS THE RIGHTS AND INTERESTS IN AND TO ISSUED
PATENTS AND PENDING PATENT APPLICATIONS (WHICH, FOR PURPOSES OF THIS AGREEMENT,
INCLUDE CERTIFICATES OF INVENTION, APPLICATIONS FOR CERTIFICATES OF INVENTION
AND PRIORITY RIGHTS) IN ANY COUNTRY OR REGION, INCLUDING ALL PROVISIONAL
APPLICATIONS, SUBSTITUTIONS, CONTINUATIONS, CONTINUATIONS-IN-PART, DIVISIONS,
RENEWALS, ALL LETTERS PATENT GRANTED THEREON, AND ALL REISSUES, RE-EXAMINATIONS
AND EXTENSIONS THEREOF, AND ALL FOREIGN COUNTERPARTS OF ANY OF THE FOREGOING.

 

1.84         “PERSON” MEANS AN INDIVIDUAL, SOLE PROPRIETORSHIP, PARTNERSHIP,
LIMITED PARTNERSHIP, LIMITED LIABILITY PARTNERSHIP, CORPORATION, LIMITED
LIABILITY COMPANY, BUSINESS TRUST, JOINT STOCK COMPANY, TRUST, INCORPORATED
ASSOCIATION, JOINT VENTURE OR SIMILAR ENTITY OR ORGANIZATION, INCLUDING A
GOVERNMENT OR POLITICAL SUBDIVISION, DEPARTMENT OR AGENCY OF A GOVERNMENT.

 

1.85         “PHASE I CLINICAL TRIAL” MEANS A CLINICAL TRIAL CONDUCTED IN
HEALTHY HUMANS OR PATIENTS, WHICH CLINICAL TRIAL IS DESIGNED TO ESTABLISH THE
SAFETY, DRUG-DRUG INTERACTIONS AND/OR PHARMACOKINETICS OF AN INVESTIGATIONAL
DRUG GIVEN ITS INTENDED USE, AND TO SUPPORT CONTINUED TESTING OF SUCH DRUG IN
PHASE II CLINICAL TRIALS.  ANY CLINICAL TRIAL IN ANY COUNTRY THAT WOULD SATISFY
THE REQUIREMENTS OF 21 CFR 312.21(A) SHALL BE A PHASE I CLINICAL TRIAL.

 

1.86         “PHASE II CLINICAL TRIAL” MEANS A CLINICAL TRIAL CONDUCTED IN
PATIENTS WITH A PARTICULAR DISEASE OR CONDITION, WHICH CLINICAL TRIAL IS
DESIGNED TO ESTABLISH THE SAFETY, APPROPRIATE DOSAGE AND PHARMACOLOGICAL
ACTIVITY OF AN INVESTIGATIONAL DRUG GIVEN ITS INTENDED USE, AND TO

 

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INITIALLY EXPLORE ITS EFFICACY FOR SUCH DISEASE OR CONDITION AND TO SUPPORT
CONTINUED TESTING OF SUCH DRUG IN PHASE III CLINICAL TRIALS.  ANY CLINICAL TRIAL
IN ANY COUNTRY THAT WOULD SATISFY THE REQUIREMENTS OF 21 CFR 312.21(B) SHALL BE
A PHASE II CLINICAL TRIAL.

 

1.87         “PHASE III CLINICAL TRIAL” MEANS A PIVOTAL CLINICAL TRIAL CONDUCTED
IN PATIENTS WITH A PARTICULAR DISEASE OR CONDITION, WHICH CLINICAL TRIAL IS
DESIGNED TO ASCERTAIN EFFICACY AND SAFETY OF AN INVESTIGATIONAL DRUG FOR ITS
INTENDED USE AND TO DEFINE WARNINGS, PRECAUTIONS AND ADVERSE EVENTS THAT ARE
ASSOCIATED WITH THE LICENSED PRODUCT IN THE DOSAGE RANGE INTENDED TO BE
PRESCRIBED, WITH THE PURPOSE OF PREPARING AND SUBMITTING APPLICATIONS FOR
REGULATORY APPROVAL OR LABEL EXPANSION TO THE PERTINENT REGULATORY AUTHORITY IN
ANY COUNTRY.  ANY CLINICAL TRIAL IN ANY COUNTRY THAT WOULD SATISFY THE
REQUIREMENTS OF 21 CFR 312.21(C) SHALL BE A PHASE III CLINICAL TRIAL.

 

1.88         “PRIMARY DETAIL EQUIVALENT” MEANS (I) IF ONLY A LICENSED PRODUCT IS
DETAILED, ONE DETAIL OF SUCH LICENSED PRODUCT OR (II) IF A LICENSED PRODUCT IS
DETAILED WITH ANOTHER PRODUCT, * PERCENT (*%) OF A DETAIL IF THE LICENSED
PRODUCT IS DETAILED IN THE FIRST POSITION AND * PERCENT (*%) OF A DETAIL IF THE
LICENSED PRODUCT IS DETAILED IN THE SECOND POSITION OR (III) IF A LICENSED
PRODUCT IS DETAILED OTHER THAN IN THE FIRST OR SECOND POSITION, SUCH PERCENTAGE
OF A DETAIL AS THE PARTIES SHALL AGREE UPON IN THE CO-COMMERCIALIZATION
AGREEMENT.

 

1.89         “PRIMARY DEVELOPMENT COMPOUND” MEANS ANY COLLABORATION COMPOUND
THAT THE JRC DETERMINES HAS SATISFIED ALL APPLICABLE ADVANCEMENT CRITERIA TO
ADVANCE FROM LEAD OPTIMIZATION TO PRECLINICAL STUDIES AND THAT DS HAS DESIGNATED
AS A PRIMARY DEVELOPMENT COMPOUND; PROVIDED, THAT, NO COLLABORATION COMPOUND
SHALL, AFTER BECOMING A WAIVED COMPOUND OR TERMINATED COMPOUND, BE DESIGNATED BY
DS AS A PRIMARY DEVELOPMENT COMPOUND.

 

1.90         “PROGRAM PATENT RIGHTS” MEANS ANY PATENT RIGHTS THAT CONTAIN ONE OR
MORE CLAIMS THAT COVER PROGRAM TECHNOLOGY.

 

1.91         “PROGRAM TECHNOLOGY” MEANS ANY TECHNOLOGY (INCLUDING, WITHOUT
LIMITATION, ANY NEW AND USEFUL PROCESS, METHOD OF MANUFACTURE OR COMPOSITION OF
MATTER) OR PROPRIETARY MATERIALS THAT ARE CONCEIVED OR FIRST REDUCED TO PRACTICE
(ACTIVELY OR CONSTRUCTIVELY) BY EITHER

 

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PARTY IN THE CONDUCT OF THE RESEARCH PROGRAM AND/OR THE DEVELOPMENT PROGRAM,
INCLUDING BUT NOT LIMITED TO A PROCESS FOR MODIFYING, OPTIMIZING, USING,
FORMULATING, DELIVERING AND/OR STABILIZING ANY COLLABORATION COMPOUND OR
LICENSED PRODUCT.

 

1.92                           “PROPRIETARY MATERIALS” MEANS TANGIBLE CHEMICAL,
BIOLOGICAL OR PHYSICAL MATERIALS (A) THAT ARE FURNISHED BY OR ON BEHALF OF ONE
PARTY TO THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT, WHETHER OR NOT
SPECIFICALLY DESIGNATED AS PROPRIETARY BY THE TRANSFERRING PARTY OR (B) THAT ARE
OTHERWISE CONCEIVED OR REDUCED TO PRACTICE IN THE CONDUCT OF THE RESEARCH
PROGRAM OR THE DEVELOPMENT PROGRAM.

 

1.93                           “QUARTERLY FTE PAYMENT” MEANS THE AMOUNT PAYABLE
BY DS TO ARQULE FOR FTES FOR ALL ARQULE RESEARCH ACTIVITIES TO BE CONDUCTED
DURING EACH CALENDAR QUARTER OF THE RESEARCH COLLABORATION PERIOD, WHICH SHALL
EQUAL * PERCENT (*%) OF THE FTE FUNDING COMMITMENT SET FORTH IN THE ANNUAL
RESEARCH PLAN FOR THE APPLICABLE CALENDAR YEAR, PROVIDED, THAT SUCH AMOUNT SHALL
BE PRORATED FOR THE FIRST AND LAST CALENDAR QUARTER BASED ON THE NUMBER OF DAYS
IN SUCH FIRST OR LAST CALENDAR QUARTER DIVIDED BY 365.

 

1.94                           “REGULATORY APPROVAL” MEANS, WITH RESPECT TO ANY
COUNTRY OR REGION IN THE TERRITORY, ANY APPROVAL, PRODUCT AND ESTABLISHMENT
LICENSE, REGISTRATION OR AUTHORIZATION OF ANY REGULATORY AUTHORITY REQUIRED FOR
THE MANUFACTURE, USE, STORAGE, IMPORTATION, EXPORTATION, DISTRIBUTION, TRANSPORT
OR SALE OF A LICENSED PRODUCT FOR USE IN THE FIELD IN SUCH COUNTRY OR REGION.

 

1.95                           “REGULATORY AUTHORITY” MEANS THE FDA IN THE
UNITED STATES, THE EMEA IN THE EU, THE MINISTRY OF HEALTH, LABOR AND WELFARE IN
JAPAN, OR ANY COUNTERPART OF ANY OF THE FOREGOING IN ANY OTHER JURISDICTION, OR
ANY OTHER NATIONAL, SUPRA-NATIONAL, REGIONAL, STATE OR LOCAL REGULATORY AGENCY,
DEPARTMENT, BUREAU, COMMISSION, COUNCIL OR OTHER GOVERNMENTAL ENTITY WITH
AUTHORITY OVER THE DISTRIBUTION, IMPORTATION, EXPORTATION, MANUFACTURE,
PRODUCTION, USE, STORAGE, TRANSPORT, CLINICAL TESTING OR SALE OF A LICENSED
PRODUCT.

 

1.96                           “REGULATORY FILINGS” MEANS, COLLECTIVELY: (A) ALL
INDS, ESTABLISHMENT LICENSE APPLICATIONS, DRUG MASTER FILES, APPLICATIONS FOR
DESIGNATION AS AN “ORPHAN PRODUCT(S)” UNDER THE ORPHAN DRUG ACT, FOR “FAST
TRACK” STATUS UNDER SECTION 506 OF THE FDCA (21 U.S.C. § 356) OR FOR A SPECIAL
PROTOCOL ASSESSMENT UNDER SECTION 505(B)(4)(B) AND (C) OF THE FDCA (21 U.S.C.

 

18

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§ 355(B)(4)(B)), NDAS AND BLAS AND ALL OTHER SIMILAR FILINGS (INCLUDING, WITHOUT
LIMITATION, COUNTERPARTS OF ANY OF THE FOREGOING) IN ANY COUNTRY OR REGION IN
THE TERRITORY; (B) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE FOREGOING; AND
(C) ALL DATA AND OTHER INFORMATION CONTAINED IN, AND CORRESPONDENCE RELATING TO,
ANY OF THE FOREGOING.

 

1.97                           “RESEARCH COLLABORATION PERIOD” MEANS THE PERIOD
BEGINNING ON THE EFFECTIVE DATE AND ENDING ON THE * ANNIVERSARY THEREOF, AS SUCH
PERIOD MAY BE EXTENDED BY THE MUTUAL WRITTEN AGREEMENT OF THE PARTIES; PROVIDED,
THAT, (A) DS SHALL HAVE THE RIGHT TO EXTEND THE RESEARCH COLLABORATION PERIOD BY
* (*) * (*) * BY PROVIDING WRITTEN NOTICE TO ARQULE NOT LESS THAN * (*) * PRIOR
TO THE EXPIRATION OF THE THEN-APPLICABLE RESEARCH COLLABORATION PERIOD AND
(B) IF THIS AGREEMENT IS TERMINATED PRIOR TO THE END OF THE RESEARCH
COLLABORATION PERIOD, THE EFFECTIVE DATE OF SUCH EARLY TERMINATION SHALL BECOME
THE LAST DAY OF THE RESEARCH COLLABORATION PERIOD.

 

1.98                           “RESEARCH PROGRAM” MEANS THE RESEARCH PROGRAM TO
BE CONDUCTED BY THE PARTIES DURING THE RESEARCH COLLABORATION PERIOD PURSUANT TO
THE ANNUAL RESEARCH PLANS WHICH SHALL INVOLVE THE IDENTIFICATION AND PRECLINICAL
DEVELOPMENT OF COLLABORATION COMPOUNDS THROUGH ALL RESEARCH STAGES.  FOR
PURPOSES OF CLARITY, THE RESEARCH PROGRAM DOES NOT INCLUDE ANY DEVELOPMENT
ACTIVITIES PERFORMED IN THE COURSE OF THE DEVELOPMENT PROGRAM.

 

1.99                           “RESEARCH STAGE” MEANS EACH STAGE OF THE RESEARCH
PROGRAM DESCRIBED MORE FULLY ON SCHEDULE 1 ATTACHED HERETO AND INCORPORATED
HEREIN BY REFERENCE.  FOR PURPOSES OF CLARITY, THE RESEARCH STAGES SHALL CONSIST
OF (A) ASSAY DEVELOPMENT AND HIT GENERATION ; (B) HIT TO LEAD; (C) LEAD
OPTIMIZATION AND (D) PRECLINICAL STUDIES.

 

1.100                     “ROYALTY TERM” MEANS, ON A LICENSED
PRODUCT-BY-LICENSED PRODUCT AND COUNTRY-BY-COUNTRY BASIS, THE PERIOD BEGINNING
ON THE DATE OF FIRST COMMERCIAL SALE OF A LICENSED PRODUCT IN A COUNTRY AND
ENDING ON THE LATER TO OCCUR OF (A) EXPIRATION OF THE LAST TO EXPIRE VALID CLAIM
OF THE LICENSED PATENT RIGHTS OR JOINT PATENT RIGHTS IN SUCH COUNTRY THAT COVERS
SUCH LICENSED PRODUCT OR ITS IDENTIFICATION, MANUFACTURE, USE, IMPORT, OFFER FOR
SALE OR SALE OR (B) * (*) YEARS FROM THE DATE OF THE FIRST COMMERCIAL SALE OF
SUCH  LICENSED PRODUCT IN SUCH COUNTRY.

 

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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

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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 TO THE END OF THE DS OPTION PERIOD FOR THE DS TARGET OF SUCH COLLABORATION
COMPOUND, AND (C) ANY PRIMARY DEVELOPMENT COMPOUND, BACKUP COMPOUND OR LICENSED
PRODUCT THE DEVELOPMENT OR COMMERCIALIZATION OF WHICH IS ABANDONED OR
DISCONTINUED BY DS.

 

Additional Definitions.  In addition, each of the following definitions shall
have the respective meanings set forth in the section of this Agreement
indicated below:

 

Definition

 

Section

 

 

 

Abandoning Party

 

9.1.5(b)

Additional Indication

 

4.11

Additional Indication Notice

 

4.11

 

21

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Agreement

 

Recitals

Alliance Manager

 

2.4

ARQULE

 

Recitals

ARQULE Indemnitees

 

12.2

ARQULE Program Patent Right

 

9.2.1(c)(ii)

Available Target

 

3.5.2(c)

Available Target Response

 

3.5.2(c)

Blocked Target List

 

3.5.2(b)

Claims

 

12.1

Collaboration Compound Notice

 

3.6

Co-Commercialization Agreement

 

4.10.2(a)(iii) (A)

Co-Commercialization Option

 

4.10.2(a)(ii)

Co-Commercialization Option Notice

 

4.10.2(a)(ii)

Co-Commercialization Plan

 

4.10.2(b)

Co-Commercialized Licensed Product

 

4.10.2(a)(ii)

Designated Senior Officers

 

2.1.5

Desired Target

 

3.5.2(c)

Desired Target Notice

 

3.5.2(c)

Dispute

 

13.1.1

Disputed Matter

 

2.1.5

DS

 

Recitals

DS Backup Compound Notice

 

7.1.2(b)

DS Indemnitees

 

12.1

DS Option

 

7.1.1

DS Option Exercise Notice

 

7.1.2(a)

Expert

 

13.1.2(a)

Filing Party

 

9.1.4

Gatekeeper

 

3.5.2(b)

Generic Licensed Product

 

Schedule 3

Hit

 

3.6

Indemnified Party

 

12.3

Indemnifying Party

 

12.3

Infringement

 

9.2.1(a)

Infringement Notice

 

9.2.1(a)

Initial DS Targets

 

3.5.1

License Agreement

 

7.1.2(a)

License Fee

 

5.2

Losses

 

12.1

Maintaining Party

 

9.1.5(b)

non-Appointing Party

 

2.6

Non-Filing Party

 

9.1.4

Party/Parties

 

Recitals

Patent Coordinator

 

8.4

Recipient Party

 

3.8

Term

 

10.1

Third Party Costs

 

5.3.2

 

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Toxicology Studies Results

 

3.4.2

Transferring Party

 

3.8

Upfront Fee

 

5.1

Validated Target

 

3.5.2(d)

Validated Target Notice

 

3.5.2(d)

 

2.                                      ADMINISTRATION OF THE COLLABORATION

 

2.1                                 JOINT EXECUTIVE COMMITTEE.

 

2.1.1                                 ESTABLISHMENT.  WITHIN FIFTEEN (15) DAYS
OF THE EFFECTIVE DATE, ARQULE AND DS SHALL ESTABLISH THE JOINT EXECUTIVE
COMMITTEE.  UNLESS OTHERWISE AGREED BY THE PARTIES, THE TERM OF THE JEC SHALL
CONTINUE UNTIL THE LATER OF (A) TERMINATION OF THIS AGREEMENT OR (B) TERMINATION
OF THE LAST LICENSE AGREEMENT TO TERMINATE.

 

2.1.2                                 MEMBERSHIP.  UPON ESTABLISHMENT OF THE
JEC, EACH PARTY SHALL DESIGNATE IN WRITING, IN ITS SOLE DISCRETION, ONE
(1) PERSON TO BE ITS INITIAL MEMBER OF THE JEC, AND UPON THE FIRST EXERCISE OF A
DS OPTION, TWO (2) ADDITIONAL PERSONS OR SUCH OTHER EQUAL NUMBER OF PERSONS TO
BE MEMBERS OF THE JEC AS THE PARTIES AGREE TO (WHO SHALL BE MEMBERS OF ITS
MANAGEMENT).  UNLESS OTHERWISE AGREED BY THE PARTIES, EACH PARTY’S INITIAL
MEMBER SHALL BE DESIGNATED AS CO-CHAIRS OF THE JEC  AND UPON APPOINTMENT OF THE
ADDITIONAL MEMBERS, ONE OF DS’S DESIGNEES AND ONE OF ARQULE’S DESIGNEES SHALL BE
DESIGNATED AS CO-CHAIRS OF THE JEC.  EACH PARTY SHALL HAVE THE RIGHT AT ANY TIME
TO SUBSTITUTE INDIVIDUALS, ON A PERMANENT OR TEMPORARY BASIS, FOR ANY OF ITS
PREVIOUSLY DESIGNATED REPRESENTATIVES TO THE JEC, BY GIVING WRITTEN NOTICE TO
THE OTHER PARTY.  INITIAL DESIGNEES OF THE PARTIES TO THE JEC SHALL BE
DESIGNATED BY EACH PARTY BY WRITTEN NOTICE TO THE OTHER PARTY AS SOON AS IS
REASONABLY PRACTICABLE FOLLOWING THE EFFECTIVE DATE.

 

2.1.3                                 MEETINGS.

 

(A)                                  SCHEDULE OF MEETINGS; AGENDA.  THE JEC
SHALL ESTABLISH A SCHEDULE OF TIMES FOR REGULAR MEETINGS, TAKING INTO ACCOUNT
THE PLANNING NEEDS OF THE COLLABORATION AND ITS RESPONSIBILITIES.  IN URGENT
CASES, SPECIAL MEETINGS OF THE JEC MAY BE CONVENED BY ANY MEMBER UPON THIRTY
(30) DAYS (OR, IF SUCH MEETING IS PROPOSED TO BE CONDUCTED BY TELECONFERENCE,
UPON TEN (10) DAYS) WRITTEN NOTICE TO THE OTHER MEMBERS; PROVIDED, THAT,
(I) NOTICE OF ANY SUCH SPECIAL MEETING MAY BE WAIVED AT ANY TIME, EITHER BEFORE
OR AFTER SUCH MEETING, AND SUCH WAIVER SHALL BE

 

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THE EQUIVALENT TO THE GIVING OF A VALID NOTICE HEREUNDER, AND (II) ATTENDANCE OF
ANY MEMBER AT A SPECIAL MEETING SHALL CONSTITUTE A VALID WAIVER OF NOTICE FROM
SUCH MEMBER.  IN NO EVENT SHALL THE JEC MEET LESS FREQUENTLY THAN TWO (2) TIMES
IN EACH CALENDAR YEAR.  REGULAR AND SPECIAL MEETINGS OF THE JEC MAY BE HELD IN
PERSON OR BY TELECONFERENCE OR VIDEOCONFERENCE; PROVIDED, THAT, MEETINGS HELD IN
PERSON SHALL ALTERNATE BETWEEN THE RESPECTIVE OFFICES OF THE PARTIES.  THE
CO-CHAIRS SHALL PREPARE AND CIRCULATE TO EACH JEC MEMBER AN AGENDA FOR EACH JEC
MEETING NOT LATER THAN ONE (1) WEEK PRIOR TO SUCH MEETING.

 

(B)                                 QUORUM; VOTING; DECISIONS.  AT EACH JEC
MEETING AFTER THE APPOINTMENT OF THE ADDITIONAL MEMBERS, (I) THE PRESENCE IN
PERSON OF AT LEAST TWO (2) MEMBERS DESIGNATED BY EACH PARTY SHALL CONSTITUTE A
QUORUM AND (II) ALL MEMBERS DESIGNATED BY EACH PARTY WHO ARE PRESENT SHALL HAVE
ONE COLLECTIVE VOTE ON ALL MATTERS BEFORE THE JEC AT SUCH MEETING.  ALL
DECISIONS OF THE JEC SHALL BE MADE BY UNANIMOUS VOTE.  ALTERNATIVELY, THE JEC
MAY ACT BY WRITTEN CONSENT SIGNED BY THE CO-CHAIRS.  WHENEVER ANY ACTION BY THE
JEC IS CALLED FOR HEREUNDER DURING A TIME PERIOD IN WHICH THE JEC IS NOT
SCHEDULED TO MEET, EITHER CO-CHAIR SHALL CAUSE THE JEC TO MEET TO TAKE THE
ACTION IN THE REQUESTED TIME PERIOD BY CALLING A SPECIAL MEETING OR THE
CO-CHAIRS SHALL ACT BY WRITTEN CONSENT.  REPRESENTATIVES OF EACH PARTY OR OF ITS
AFFILIATES WHO ARE NOT MEMBERS OF THE JEC MAY ATTEND JEC MEETINGS AS NON-VOTING
OBSERVERS WITH THE CONSENT OF THE OTHER PARTY, WHICH SHALL NOT BE UNREASONABLY
WITHHELD, CONDITIONED OR DELAYED.

 

(C)                                  MINUTES.  THE JEC SHALL KEEP MINUTES OF ITS
MEETINGS THAT RECORD ALL DECISIONS AND ALL ACTIONS RECOMMENDED OR TAKEN IN
REASONABLE DETAIL.  DRAFTS OF THE MINUTES SHALL BE PREPARED AND CIRCULATED TO
THE MEMBERS OF THE JEC WITHIN A REASONABLE TIME AFTER THE MEETING, NOT TO EXCEED
TEN (10) BUSINESS DAYS.  THE CO-CHAIRS SHALL HAVE RESPONSIBILITY FOR THE
PREPARATION AND CIRCULATION OF DRAFT MINUTES.  EACH MEMBER OF THE JEC SHALL HAVE
THE OPPORTUNITY TO PROVIDE COMMENTS ON THE DRAFT MINUTES.  THE MINUTES SHALL BE
APPROVED, DISAPPROVED AND REVISED AS NECESSARY AT THE NEXT JEC MEETING OR WITHIN
THIRTY (30) DAYS OF THE MEETING WHICHEVER OCCURS FIRST.  UPON APPROVAL, FINAL
MINUTES OF EACH MEETING SHALL BE CIRCULATED TO THE MEMBERS OF THE JEC BY THE
CO-CHAIRS.

 

2.1.4                                 RESPONSIBILITIES.  THE JEC SHALL BE
RESPONSIBLE FOR OVERSEEING THE CONDUCT AND PROGRESS OF THE RESEARCH PROGRAM, THE
DEVELOPMENT OF PRIMARY DEVELOPMENT

 

24

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COMPOUNDS AND RELATED BACKUP COMPOUNDS AND THE COMMERCIALIZATION OF LICENSED
PRODUCTS.  WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, THE JEC SHALL HAVE
THE FOLLOWING RESPONSIBILITIES:

 

(A)                                  APPROVING EACH ANNUAL RESEARCH PLAN,
INCLUDING AMENDMENTS THERETO;

 

(B)                                 OVERSEEING THE JRC’S AND USCC’S PERFORMANCE
OF ITS RESPECTIVE RESPONSIBILITIES;

 

(C)                                  REVIEWING AND OVERSEEING DEVELOPMENT
ACTIVITIES AND SERVING AS A FORUM FOR DISCUSSING DEVELOPMENT OF PRIMARY
DEVELOPMENT COMPOUNDS, BACKUP COMPOUNDS AND LICENSED PRODUCTS ;

 

(D)                                 REVIEWING AND OVERSEEING COMMERCIALIZATION
OF LICENSED PRODUCTS AND SERVING AS A FORUM FOR DISCUSSING THE WORLDWIDE PLAN
AND STRATEGY FOR COMMERCIALIZATION OF LICENSED PRODUCTS;

 

(E)                                  RESOLVING ALL JRC MATTERS THAT ARE IN
DISPUTE OTHER THAN THOSE RELATE TO A DS DECISION OR ARQULE DECISION; AND

 

(F)                                    MAKING SUCH OTHER DECISIONS AS MAY BE
DELEGATED TO THE JEC PURSUANT TO THIS AGREEMENT OR BY MUTUAL WRITTEN AGREEMENT
OF THE PARTIES AFTER THE EFFECTIVE DATE.

 

2.1.5                                 DISPUTE RESOLUTION.  THE JEC MEMBERS SHALL
USE REASONABLE EFFORTS TO REACH AGREEMENT ON ANY AND ALL MATTERS.  IN THE EVENT
THAT, DESPITE SUCH REASONABLE EFFORTS, AGREEMENT ON A PARTICULAR MATTER CANNOT
BE REACHED BY THE JEC WITHIN * (*) DAYS AFTER THE JEC FIRST MEETS TO CONSIDER
SUCH MATTER (EACH SUCH MATTER, A “DISPUTED MATTER”), THEN, (A) IF THE DISPUTED
MATTER INVOLVES A DS DECISION, DS SHALL HAVE THE RIGHT TO MAKE THE FINAL
DECISION ON SUCH DISPUTED MATTER BUT SHALL ONLY EXERCISE SUCH RIGHT IN GOOD
FAITH AFTER FULL CONSIDERATION OF THE POSITIONS OF BOTH PARTIES; (B) IF THE
DISPUTED MATTER INVOLVES AN ARQULE DECISION, ARQULE SHALL HAVE THE RIGHT TO MAKE
THE FINAL DECISION ON SUCH DISPUTED MATTER BUT SHALL ONLY EXERCISE SUCH RIGHT IN
GOOD FAITH AFTER FULL CONSIDERATION OF THE POSITIONS OF BOTH PARTIES AND (C) IF
THE DISPUTED MATTER INVOLVES A UNANIMOUS DECISION, (I) THE CO-CHAIRS OF THE JEC
SHALL REFER SUCH DISPUTED MATTER TO THE CEO OF ARQULE AND THE HEAD OF R&D
DIVISION OF DS (THE “DESIGNATED SENIOR OFFICERS”), WHO SHALL PROMPTLY INITIATE
DISCUSSIONS IN GOOD FAITH TO RESOLVE SUCH DISPUTED MATTER AND (II) IF SUCH
DISPUTED MATTER IS NOT RESOLVED BY THE DESIGNATED SENIOR OFFICERS WITHIN * (*)
DAYS AFTER THE DATE THE DESIGNATED SENIOR OFFICERS FIRST MET TO CONSIDER SUCH

 

25

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DISPUTED MATTER OR * (*) DAYS AFTER THE DATE THE JEC FIRST MET TO CONSIDER SUCH
DISPUTED MATTER, WHICHEVER IS LATER, THE DISPUTED MATTER SHALL BE RESOLVED IN
ACCORDANCE WITH SECTION 13.1.

 

2.2                                 JOINT RESEARCH COMMITTEE.

 

2.2.1                                 ESTABLISHMENT.  WITHIN FIFTEEN (15) DAYS
OF THE EFFECTIVE DATE, ARQULE AND DS SHALL ESTABLISH THE JOINT RESEARCH
COMMITTEE.  UNLESS OTHERWISE AGREED BY THE PARTIES, THE TERM FOR THE JRC SHALL
COMMENCE AS OF THE EFFECTIVE DATE AND CONTINUE UNTIL THE LATER OF (I) THE LAST
DAY OF THE RESEARCH COLLABORATION PERIOD, OR (II) THE EXPIRATION OF THE LAST DS
OPTION PERIOD.  THE JRC SHALL HAVE AND PERFORM THE RESPONSIBILITIES SET FORTH IN
SECTION 2.2.4.

 

2.2.2                                 MEMBERSHIP.  UPON ESTABLISHMENT OF THE
JRC, EACH PARTY SHALL DESIGNATE IN WRITING, IN ITS SOLE DISCRETION, THREE (3) OR
SUCH OTHER EQUAL NUMBER OF MEMBERS AS THE PARTIES AGREE, TO THE JRC (WHICH
MEMBERS SHALL BE EMPLOYEES OF SUCH PARTY OR ITS AFFILIATES).  UNLESS OTHERWISE
AGREED BY THE PARTIES, ONE OF DS’S DESIGNEES AND ONE OF ARQULE’S DESIGNEES SHALL
BE DESIGNATED AS THE CO-CHAIRS OF THE JRC.  EACH PARTY SHALL HAVE THE RIGHT AT
ANY TIME TO SUBSTITUTE INDIVIDUALS, ON A PERMANENT OR TEMPORARY BASIS, FOR ANY
OF ITS PREVIOUSLY DESIGNATED REPRESENTATIVES TO THE JRC, BY GIVING WRITTEN
NOTICE TO THE OTHER PARTY.  INITIAL DESIGNEES OF THE PARTIES TO THE JRC SHALL BE
DESIGNATED BY EACH PARTY BY WRITTEN NOTICE TO THE OTHER PARTY WITHIN FIFTEEN
(15) DAYS FOLLOWING THE EFFECTIVE DATE.

 

2.2.3                                 MEETINGS.

 

(A)                                  SCHEDULE OF MEETINGS; AGENDA.  THE JRC
SHALL ESTABLISH A SCHEDULE OF TIMES FOR REGULAR MEETINGS, IN NO EVENT LESS
FREQUENTLY THAN ONCE PER CALENDAR QUARTER AND AT SUCH OTHER TIMES AS THE PARTIES
AGREE DURING THE RESEARCH COLLABORATION PERIOD TAKING INTO ACCOUNT, WITHOUT
LIMITATION, THE PLANNING NEEDS OF THE RESEARCH PROGRAM AND ITS
RESPONSIBILITIES.  IN URGENT CASES SPECIAL MEETINGS MAY BE CONVENED BY ANY
MEMBER UPON THIRTY (30) DAYS (OR, IF SUCH MEETING IS PROPOSED TO BE CONDUCTED BY
TELECONFERENCE, UPON TEN (10) DAYS) WRITTEN NOTICE TO THE OTHER MEMBERS;
PROVIDED, THAT, (I) NOTICE OF ANY SUCH SPECIAL MEETING MAY BE WAIVED AT ANY
TIME, EITHER BEFORE OR AFTER SUCH MEETING, AND SUCH WAIVER SHALL BE THE
EQUIVALENT TO THE GIVING OF A VALID NOTICE HEREUNDER, AND (II) ATTENDANCE OF ANY
MEMBER AT A SPECIAL MEETING SHALL CONSTITUTE A VALID WAIVER OF NOTICE FROM SUCH
MEMBER.  REGULAR AND SPECIAL MEETINGS OF THE JRC

 

26

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MAY BE HELD IN PERSON OR BY TELECONFERENCE OR VIDEOCONFERENCE; PROVIDED, THAT,
MEETINGS HELD IN PERSON SHALL ALTERNATE BETWEEN THE RESPECTIVE OFFICES OF THE
PARTIES.  THE CO-CHAIRS OF THE JRC SHALL PREPARE AND CIRCULATE TO EACH JRC
MEMBER AN AGENDA FOR EACH JRC MEETING NO LATER THAN ONE (1) WEEK PRIOR TO SUCH
MEETING.  NOTWITHSTANDING THE FOREGOING, THE JRC SHALL MEET FACE-TO-FACE AT
LEAST TWICE PER CALENDAR YEAR, ONE OF WHICH SHALL BE HELD IN THE UNITED STATES
AND ONE OF WHICH SHALL BE HELD IN JAPAN.

 

(B)                                 QUORUM; VOTING; DECISIONS.  AT EACH JRC
MEETING, (I) THE PRESENCE IN PERSON OF AT LEAST TWO (2) MEMBERS DESIGNATED BY
EACH PARTY SHALL CONSTITUTE A QUORUM AND (II) ALL MEMBERS DESIGNATED BY EACH
PARTY WHO ARE PRESENT SHALL HAVE ONE COLLECTIVE VOTE ON ALL MATTERS BEFORE THE
JRC AT SUCH MEETING.  ALL DECISIONS OF THE JRC SHALL BE MADE BY UNANIMOUS VOTE. 
ALTERNATIVELY, THE JRC MAY ACT BY WRITTEN CONSENT SIGNED BY THE CO-CHAIRS. 
WHENEVER ANY ACTION BY THE JRC IS CALLED FOR HEREUNDER DURING A TIME PERIOD IN
WHICH THE JRC IS NOT SCHEDULED TO MEET, EITHER CO-CHAIR SHALL CAUSE THE JRC TO
MEET TO TAKE THE ACTION IN THE REQUESTED TIME PERIOD BY CALLING A SPECIAL
MEETING OR THE CO-CHAIRS SHALL ACT BY WRITTEN CONSENT.  REPRESENTATIVES OF EACH
PARTY OR OF ITS AFFILIATES WHO ARE NOT MEMBERS OF THE JRC (INCLUDING, WITHOUT
LIMITATION, THE PATENT COORDINATORS) MAY ATTEND JRC MEETINGS AS NON-VOTING
OBSERVERS WITHOUT THE CONSENT OF THE OTHER PARTY.

 

(C)                                  MINUTES.  THE JRC SHALL KEEP MINUTES OF ITS
MEETINGS THAT RECORD ALL DECISIONS AND ALL ACTIONS RECOMMENDED OR TAKEN IN
REASONABLE DETAIL.  DRAFTS OF THE MINUTES SHALL BE PREPARED AND CIRCULATED TO
THE MEMBERS OF THE JRC WITHIN A REASONABLE TIME AFTER THE MEETING, NOT TO EXCEED
TEN (10) BUSINESS DAYS.  THE CO-CHAIRS OF THE JRC SHALL HAVE RESPONSIBILITY FOR
THE PREPARATION AND CIRCULATION OF DRAFT MINUTES.  EACH MEMBER OF THE JRC SHALL
HAVE THE OPPORTUNITY TO PROVIDE COMMENTS ON THE DRAFT MINUTES.  THE MINUTES
SHALL BE APPROVED, DISAPPROVED AND REVISED AS NECESSARY AT THE NEXT JRC
MEETING.  UPON APPROVAL, FINAL MINUTES OF EACH MEETING SHALL BE CIRCULATED TO
THE MEMBERS OF THE JRC BY THE CO-CHAIRS OF THE JRC.

 

2.2.4                                 RESPONSIBILITIES.  THE JRC SHALL BE
RESPONSIBLE FOR OVERSEEING THE CONDUCT AND PROGRESS OF THE RESEARCH PROGRAM. 
WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, THE JRC SHALL HAVE THE
FOLLOWING RESPONSIBILITIES:

 

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(A)                                  ESTABLISHING THE OBJECTIVES OF AND THE
APPROPRIATE ALLOCATION OF RESOURCES (INCLUDING PERSONNEL) TO THE RESEARCH
PROGRAM;

 

(B)                                 PREPARING OR DIRECTING THE PREPARATION OF
AND SUBMITTING ALL ANNUAL RESEARCH PLANS TO THE JEC FOR APPROVAL;

 

(C)                                  PREPARING OR DIRECTING THE PREPARATION OF
AND SUBMITTING AMENDMENTS TO ANNUAL RESEARCH PLANS TO THE JEC FOR APPROVAL;

 

(D)                                 MONITORING THE PROGRESS OF EACH ANNUAL
RESEARCH PLAN AND OF EACH PARTY’S ACTIVITIES UNDER EACH ANNUAL RESEARCH PLAN;

 

(E)                                  PROVIDING A FORUM FOR CONSENSUAL DECISION
MAKING WITH RESPECT TO THE RESEARCH PROGRAM;

 

(F)                                    REVIEWING DATA, REPORTS OR OTHER
INFORMATION SUBMITTED BY EITHER PARTY WITH RESPECT TO WORK CONDUCTED IN THE
RESEARCH PROGRAM;

 

(G)                                 PREPARING FOR THE JEC ON AT LEAST A
SEMI-ANNUAL BASIS A PROGRESS REPORT FOR THE RESEARCH PROGRAM IN REASONABLE
DETAIL AND PROVIDING TO THE JEC SUCH ADDITIONAL INFORMATION AS IT MAY REQUEST;

 

(H)                                 RECOMMENDING AMENDMENTS TO THE ADVANCEMENT
CRITERIA APPLICABLE TO ANY RESEARCH STAGE AS IT DEEMS APPROPRIATE IN FURTHERANCE
OF THE OBJECTIVES OF THE RESEARCH PROGRAM, AS SET FORTH IN THE APPLICABLE ANNUAL
RESEARCH PLAN;

 

(I)                                     DETERMINING AT THE COMPLETION OF EACH
RESEARCH STAGE WHETHER OR NOT TO ADVANCE ANY COLLABORATION COMPOUNDS BASED ON
THE APPLICABLE ADVANCEMENT CRITERIA;

 

(J)                                     DETERMINING WHETHER EACH COLLABORATION
COMPOUND SATISFIES THE MINIMUM REQUIREMENT;

 

(K)                                  PROVIDING A FORUM FOR THE PARTIES TO
EXCHANGE AND REVIEW SCIENTIFIC INFORMATION AND DATA RELATING TO THE
COLLABORATION; AND

 

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(L)                                     MAKING ANY OTHER DECISIONS AS MAY BE
DELEGATED TO THE JRC PURSUANT TO THIS AGREEMENT OR BY MUTUAL WRITTEN AGREEMENT
OF THE PARTIES AFTER THE EFFECTIVE DATE AND PERFORMING SUCH ACTIVITIES AS MAY BE
DELEGATED TO THE JRC PURSUANT TO THIS AGREEMENT, OR BY MUTUAL WRITTEN AGREEMENT
OF THE PARTIES AFTER THE EFFECTIVE DATE.

 

2.2.5                                 DISPUTE RESOLUTION.  THE JRC MEMBERS SHALL
USE REASONABLE EFFORTS TO REACH AGREEMENT ON ANY AND ALL MATTERS.  IN THE EVENT
THAT, DESPITE SUCH REASONABLE EFFORTS, AGREEMENT ON A PARTICULAR MATTER CANNOT
BE REACHED BY THE JRC WITHIN * (*) DAYS AFTER THE JRC FIRST MEETS TO CONSIDER
SUCH MATTER, THE MATTER SHALL BE REFERRED TO THE JEC FOR RESOLUTION PURSUANT TO
SECTION 2.1.5.

 

2.3                                 US CO-COMMERCIALIZATION COMMITTEE.

 

2.3.1                                 ESTABLISHMENT.  AS SOON AS PRACTICABLE
FOLLOWING THE EXERCISE BY ARQULE OF A CO-COMMERCIALIZATION OPTION WITH RESPECT
TO A CO-COMMERCIALIZED LICENSED PRODUCT IN ACCORDANCE WITH
SECTION 4.10.2(A)(II), ARQULE AND DS SHALL ESTABLISH THE US CO-COMMERCIALIZATION
COMMITTEE WHICH SHALL HAVE AND PERFORM THE RESPONSIBILITIES SET FORTH IN
SECTION 2.3.4.

 

2.3.2                                 MEMBERSHIP.  ARQULE SHALL BE ENTITLED TO
DESIGNATE ONE (1) REPRESENTATIVE TO THE USCC (WHO SHALL BE AN EMPLOYEE OF ARQULE
OR ITS AFFILIATES).  UNLESS OTHERWISE AGREED BY THE PARTIES, ONE OF DS’S
DESIGNEES SHALL BE DESIGNATED BY DS AS THE CHAIR.  EACH PARTY SHALL HAVE THE
RIGHT AT ANY TIME TO SUBSTITUTE INDIVIDUALS, ON A PERMANENT OR TEMPORARY BASIS,
FOR ANY OF ITS PREVIOUSLY DESIGNATED REPRESENTATIVES TO THE USCC BY GIVING
WRITTEN NOTICE TO THE OTHER PARTY.  INITIAL DESIGNEES OF THE PARTIES TO THE USCC
SHALL BE DESIGNATED BY EACH PARTY BY WRITTEN NOTICE TO THE OTHER PARTY AS SOON
AS REASONABLY PRACTICABLE FOLLOWING THE ESTABLISHMENT OF THE USCC.

 

2.3.3                                 MEETINGS.

 

(A)                                  SCHEDULE OF MEETINGS; AGENDA.  THE USCC
SHALL ESTABLISH A SCHEDULE OF TIMES FOR MEETINGS.  IF FORMED, IN NO EVENT SHALL
THE USCC MEET LESS FREQUENTLY THAN TWICE PER CALENDAR YEAR.  MEETINGS OF THE
USCC MAY BE HELD IN PERSON OR BY TELECONFERENCE OR

 

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VIDEOCONFERENCE.  THE CHAIR OF THE USCC SHALL PREPARE AND CIRCULATE TO EACH USCC
MEMBER AN AGENDA FOR EACH USCC MEETING NOT LATER THAN ONE (1) WEEK PRIOR TO SUCH
MEETING.

 

2.3.4                                 RESPONSIBILITIES.  THE PRIMARY ROLE OF THE
USCC SHALL BE TO PROVIDE A FORUM TO REVIEW AND MONITOR THE PROGRESS OF ALL
CO-COMMERCIALIZATION ACTIVITIES WITH RESPECT TO THE CO-COMMERCIALIZED LICENSED
PRODUCTS IN THE CO-COMMERCIALIZATION TERRITORY.

 

2.4                                 ALLIANCE MANAGEMENT.  WITHIN FIFTEEN (15)
DAYS OF THE EFFECTIVE DATE, EACH PARTY SHALL APPOINT A PERSON WHO SHALL OVERSEE
CONTACT BETWEEN THE PARTIES FOR ALL MATTERS RELATED TO THE COLLABORATION BETWEEN
MEETINGS OF THE COMMITTEES AND SHALL HAVE SUCH OTHER RESPONSIBILITIES AS THE
PARTIES MAY MUTUALLY AGREE IN WRITING AFTER THE EFFECTIVE DATE (EACH, AN
“ALLIANCE MANAGER”).  EACH PARTY MAY REPLACE ITS ALLIANCE MANAGER AT ANY TIME BY
NOTICE IN WRITING TO THE OTHER PARTY.

 

2.5                                 INTERESTS OF THE PARTIES.  ALL DECISIONS
MADE AND ALL ACTIONS TAKEN BY ANY COMMITTEE OR THE OFFICERS OF THE PARTIES
PURSUANT TO SECTION 2.1.5 SHALL BE MADE OR TAKEN WITH DUE INTEREST OF BOTH
PARTIES CONSIDERED IN GOOD FAITH.  THIS PROVISION SHALL NOT BE SUBJECT TO
ARBITRATION OR OTHER DISPUTE RESOLUTION UNDER THIS AGREEMENT.

 

2.6                                 APPOINTMENT NOT AN OBLIGATION; NO BREACH. 
THE APPOINTMENT OF ANY MEMBERS OF A COMMITTEE AND ALLIANCE MANAGERS IS A RIGHT
OF EACH PARTY AND NOT AN OBLIGATION AND SHALL NOT BE A “DELIVERABLE” AS DEFINED
IN EITF ISSUE NO. 00-21.  EACH PARTY SHALL BE FREE TO DETERMINE NOT TO APPOINT
MEMBERS TO ANY COMMITTEE AND NOT TO APPOINT AN ALLIANCE MANAGER.  IF A PARTY
(THE “NON-APPOINTING PARTY”) DOES NOT APPOINT MEMBERS OF ANY COMMITTEE OR AN
ALLIANCE MANAGER, IT SHALL NOT BE A BREACH OF THIS AGREEMENT, NOR SHALL ANY
CONSIDERATION BE REQUIRED TO BE RETURNED, AND THE OTHER PARTY SHALL HAVE THE
VOTES AND THE DECISION-MAKING POWER OF THE NON-APPOINTING PARTY UNLESS AND UNTIL
SUCH MEMBERS ARE APPOINTED BY THE NON-APPOINTING PARTY.

 

3.                                      RESEARCH PROGRAM

 

3.1                                 OBJECTIVES OF THE RESEARCH PROGRAM.  THE
OBJECTIVES OF THE RESEARCH PROGRAM SHALL BE THE IDENTIFICATION AND PRECLINICAL
DEVELOPMENT OF COLLABORATION COMPOUNDS THAT EXHIBIT ACTIVITY AGAINST DS TARGETS.

 

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3.2                                 ANNUAL RESEARCH PLANS.  THE ANNUAL RESEARCH
PLAN FOR THE FIRST CONTRACT YEAR HAS BEEN AGREED UPON IN WRITING BY THE
PARTIES.  AN ANNUAL RESEARCH PLAN FOR EACH SUBSEQUENT CONTRACT YEAR FOR EACH DS
TARGET SHALL BE PREPARED BY OR AT THE DIRECTION OF THE JRC, APPROVED BY THE JEC
NO LATER THAN THE END OF THE THIRD QUARTER OF THE PRECEDING CONTRACT YEAR AND
ATTACHED AS AN EXHIBIT TO THE MINUTES OF THE JEC MEETING AT WHICH SUCH JEC
APPROVAL IS OBTAINED.  AS SOON AS PRACTICABLE AFTER THE DESIGNATION OF ANY
ADDITIONAL DS TARGET THE JRC SHALL PREPARE AN UPDATE TO THE ANNUAL RESEARCH PLAN
AS PROVIDED IN SECTION 3.5.2(D).  EACH ANNUAL RESEARCH PLAN SHALL: (A) SET FORTH
(I) THE RESEARCH OBJECTIVES AND ACTIVITIES TO BE PERFORMED FOR EACH RESEARCH
STAGE OF THE RESEARCH PROGRAM FOR THE CONTRACT YEAR COVERED BY THE ANNUAL
RESEARCH PLAN WITH REASONABLE SPECIFICITY; (II) THE RESEARCH PLANS AND PROTOCOLS
TO BE EMPLOYED TO COMPLETE EACH SUCH RESEARCH STAGE, INCLUDING WITHOUT
LIMITATION A DESCRIPTION OF THE TYPES OF ASSAYS (IN SILICO, IN VITRO OR IN VIVO)
TO BE DEVELOPED AND USED BY THE PARTIES; (III) THE ADVANCEMENT CRITERIA THAT THE
JRC WILL UTILIZE TO EVALUATE THE RESULTS OF EACH RESEARCH STAGE AND TO DETERMINE
WHETHER TO ADVANCE COLLABORATION COMPOUNDS TO THE NEXT RESEARCH STAGE; (IV) THE
PARTY THAT SHALL BE RESPONSIBLE FOR PERFORMING THE ACTIVITIES DESCRIBED FOR EACH
RESEARCH STAGE; (V) A TIMELINE FOR SUCH ACTIVITIES (INCLUDING ANY THIRD PARTY
COSTS TO BE INCURRED FOR OUTSOURCED RESEARCH ACTIVITIES MANAGED BY ARQULE OR
DS); AND (VI) WITH RESPECT TO ARQULE RESEARCH ACTIVITIES, THE APPLICABLE FTE
FUNDING COMMITMENT; AND (B) SHALL BE CONSISTENT WITH THE OTHER TERMS OF THIS
AGREEMENT.  SUBJECT TO THE FTE FUNDING COMMITMENT, ANY ANNUAL RESEARCH PLAN MAY
BE AMENDED FROM TIME TO TIME BY THE JRC AND APPROVED BY THE JEC PURSUANT TO
SECTION 2.1.4.  EACH AMENDMENT, MODIFICATION AND UPDATE TO THE ANNUAL RESEARCH
PLAN SHALL BE SET FORTH IN A WRITTEN DOCUMENT PREPARED BY, OR AT THE DIRECTION
OF, THE JEC, SHALL SPECIFICALLY STATE THAT IT IS AN AMENDMENT, MODIFICATION OR
UPDATE TO THE ANNUAL RESEARCH PLAN AND SHALL BE ATTACHED TO THE MINUTES OF THE
MEETING OF THE JEC AT WHICH SUCH AMENDMENT, MODIFICATION OR UPDATE WAS APPROVED.

 

3.3                                 CONDUCT OF RESEARCH PROGRAM.

 

3.3.1                                 ARQULE RESPONSIBILITIES.

 

(A)                                  ARQULE RESEARCH ACTIVITIES.  DURING THE
RESEARCH COLLABORATION PERIOD, ARQULE SHALL USE COMMERCIALLY REASONABLE EFFORTS
TO CONDUCT THE ARQULE RESEARCH

 

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ACTIVITIES USING THE NUMBER OF FTES SET FORTH IN THE ANNUAL RESEARCH PLANS.  FOR
PURPOSES OF CLARITY, UNLESS OTHERWISE SET FORTH IN ANY ANNUAL RESEARCH PLAN,
(I) ARQULE SHALL BE SOLELY RESPONSIBLE FOR THE CONDUCT OF (X) ALL FEASIBILITY
ASSESSMENT ACTIVITIES (Y) ALL ASSAY DEVELOPMENT AND HIT GENERATION ACTIVITIES
AND (Z) ALL HIT TO LEAD ACTIVITIES TO BE CONDUCTED AS PART OF THE RESEARCH
PROGRAM; AND (II) SUBJECT TO SECTION 3.3.1(B), ARQULE SHALL BE JOINTLY
RESPONSIBLE, TOGETHER WITH DS, FOR THE CONDUCT OF ALL LEAD OPTIMIZATION
ACTIVITIES AND PRECLINICAL STUDIES TO BE CONDUCTED AS PART OF THE RESEARCH
PROGRAM.

 

(B)                                 TOXICOLOGY STUDIES.  WITHOUT LIMITING THE
GENERALITY OF SECTION 3.3.1(A), WITHIN * (*) DAYS FOLLOWING THE DESIGNATION BY
DS OF A PRIMARY DEVELOPMENT COMPOUND, DS SHALL CONDUCT THE TOXICOLOGY STUDIES AS
SET FORTH IN THE ANNUAL RESEARCH PLAN APPLICABLE TO SUCH PRIMARY DEVELOPMENT
COMPOUND.  TOXICOLOGY STUDIES MAY ONLY BE CONDUCTED ON A PRIMARY DEVELOPMENT
COMPOUND OR A BACKUP COMPOUND.

 

3.3.2                                 DS RESPONSIBILITIES.  DURING THE RESEARCH
COLLABORATION PERIOD, DS SHALL: (A) PAY ARQULE THE APPLICABLE QUARTERLY FTE
PAYMENT FOR ALL ARQULE RESEARCH ACTIVITIES IN ACCORDANCE WITH SECTION 5.3.1;
(B) COMMIT SUCH RESOURCES AS ARE REASONABLY NECESSARY TO CONDUCT THE DS RESEARCH
ACTIVITIES SET FORTH IN THE ANNUAL RESEARCH PLAN; (C) USE COMMERCIALLY
REASONABLE EFFORTS TO CONDUCT THE DS RESEARCH ACTIVITIES SET FORTH IN THE ANNUAL
RESEARCH PLAN; AND (D) BEAR THE COST OF ALL TOXICOLOGY STUDIES.  FOR PURPOSES OF
CLARITY, UNLESS OTHERWISE SET FORTH IN ANY ANNUAL RESEARCH PLAN, DS SHALL BE
JOINTLY RESPONSIBLE, TOGETHER WITH ARQULE, FOR THE CONDUCT OF LEAD OPTIMIZATION
ACTIVITIES AND PRECLINICAL STUDIES TO BE CONDUCTED AS PART OF THE RESEARCH
PROGRAM AS SET FORTH IN THE ANNUAL RESEARCH PLAN.  DS MAY PARTICIPATE IN
BIOLOGICAL ASSAYS FOR THE PURPOSE OF VERIFICATION OF COLLABORATION COMPOUND
ACTIVITY IN THE HIT TO LEAD RESEARCH STAGE.

 

3.3.3                                 COMPLIANCE AND FUNDING.  EACH PARTY SHALL
PERFORM ITS OBLIGATIONS UNDER EACH ANNUAL RESEARCH PLAN IN COMPLIANCE IN ALL
MATERIAL RESPECTS WITH ALL APPLICABLE LAWS.  FOR PURPOSES OF CLARITY, WITH
RESPECT TO EACH ACTIVITY PERFORMED UNDER AN ANNUAL RESEARCH PLAN THAT WILL OR
WOULD REASONABLY BE EXPECTED TO GENERATE DATA TO BE SUBMITTED TO A REGULATORY
AUTHORITY IN SUPPORT OF A REGULATORY FILING OR DRUG APPROVAL APPLICATION, THE
PARTY PERFORMING SUCH ACTIVITY SHALL COMPLY IN ALL MATERIAL RESPECTS WITH THE
REGULATIONS AND GUIDANCE OF THE FDA

 

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THAT CONSTITUTE GOOD LABORATORY PRACTICE OR GOOD MANUFACTURING PRACTICE (OR, IF
AND AS APPROPRIATE UNDER THE CIRCUMSTANCES, INTERNATIONAL CONFERENCE ON
HARMONIZATION (ICH) GUIDANCE OR OTHER COMPARABLE REGULATION AND GUIDANCE OF ANY
REGULATORY AUTHORITY IN ANY COUNTRY OR REGION IN THE TERRITORY).  EACH PARTY
SHALL BE SOLELY RESPONSIBLE FOR PAYING THE SALARIES AND BENEFITS OF ITS
EMPLOYEES.

 

3.3.4                                 COOPERATION.  SCIENTISTS AT ARQULE AND DS
SHALL COOPERATE IN THE PERFORMANCE OF THE RESEARCH PROGRAM AND, SUBJECT TO THE
TERMS OF THIS AGREEMENT AND ANY CONFIDENTIALITY OBLIGATIONS TO THIRD PARTIES,
SHALL EXCHANGE SUCH INFORMATION AND MATERIALS AS ARE REASONABLY NECESSARY FOR
THE OTHER PARTY TO PERFORM ITS OBLIGATIONS UNDER ANY ANNUAL RESEARCH PLAN AND
ALL DATA RESULTING FROM PERFORMANCE OF THE RESEARCH PROGRAM.

 

3.4                                 RECORDS.

 

3.4.1                                 RECORD KEEPING.

 

(A)                                  RESEARCH PROGRAM RECORDS.  EACH PARTY SHALL
MAINTAIN COMPLETE AND ACCURATE RECORDS OF ITS ACTIVITIES IN THE RESEARCH PROGRAM
IN SUFFICIENT DETAIL, IN GOOD SCIENTIFIC MANNER AND OTHERWISE IN A MANNER THAT
REFLECTS ALL WORK DONE AND RESULTS ACHIEVED.  SUBJECT TO ARTICLE 6, EACH PARTY
SHALL PROVIDE THE OTHER PARTY WITH ACCESS DURING NORMAL BUSINESS HOURS AND UPON
REASONABLE ADVANCE NOTICE TO REVIEW SUCH RECORDS TO THE EXTENT REASONABLY
REQUIRED FOR SUCH OTHER PARTY’S PERFORMANCE OF ITS OBLIGATIONS UNDER THIS
AGREEMENT; PROVIDED, THAT, THE NON-REVIEWING PARTY MAY REDACT INFORMATION NOT
RELEVANT TO THE RESEARCH PROGRAM PRIOR TO SUCH REVIEW.

 

(B)                                 RECORD KEEPING POLICIES.  WITHOUT LIMITING
THE GENERALITY OF SECTION 3.4.1(A), EACH PARTY AGREES TO MAINTAIN A POLICY THAT
REQUIRES ITS EMPLOYEES AND CONSULTANTS TO RECORD AND MAINTAIN ALL DATA AND
INFORMATION DEVELOPED DURING THE RESEARCH PROGRAM.

 

3.4.2                                 REPORTS.  EACH PARTY SHALL KEEP THE JRC
REGULARLY INFORMED OF THE PROGRESS OF THE RESEARCH PROGRAM.  WITHOUT LIMITING
THE GENERALITY OF THE FOREGOING, EACH PARTY SHALL, AT LEAST ONCE EACH CALENDAR
QUARTER DURING THE RESEARCH COLLABORATION PERIOD, (A) PROVIDE REPORTS TO THE JRC
IN REASONABLE DETAIL REGARDING THE STATUS OF ITS ACTIVITIES UNDER THE RESEARCH

 

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PROGRAM, (B) ADVISE THE JRC OF ITS IDENTIFICATION OF COLLABORATION COMPOUNDS
PURSUANT TO SECTION 3.6 AND PROVIDE THE JRC WITH ANY SUPPORTING DATA APPLICABLE
TO SUCH COLLABORATION COMPOUNDS, (C) PROVIDE THE JRC WITH THE RESULTS OF
ACTIVITIES CONDUCTED IN THE RESEARCH PROGRAM WITH RESPECT TO EACH COLLABORATION
COMPOUND SO AS TO ENABLE THE JRC TO DETERMINE WHETHER SUCH COLLABORATION
COMPOUND MEETS THE ADVANCEMENT CRITERIA AND SHOULD BE ADVANCED BY THE JRC TO THE
NEXT RESEARCH STAGE, (D) PROVIDE THE JRC WITH THE RESULTS OF THE TOXICOLOGY
STUDIES WITH RESPECT TO EACH PRIMARY DEVELOPMENT COMPOUND OR BACKUP COMPOUND SO
AS TO ENABLE DS TO DETERMINE WHETHER TO EXERCISE THE DS OPTION APPLICABLE
THERETO (SUCH NOTICE, THE “TOXICOLOGY STUDIES RESULTS”), (E) PROVIDE THE JRC
WITH SUCH ADDITIONAL INFORMATION THAT IT HAS IN ITS POSSESSION AS MAY BE
REASONABLY REQUESTED FROM TIME TO TIME BY THE JRC, AND (F) PROVIDE THE JRC, ON
OR BEFORE * (*) DAYS FROM THE TERMINATION OR EXPIRATION OF THE RESEARCH
COLLABORATION PERIOD, WITH A FINAL REPORT REGARDING ALL ARQULE RESEARCH
ACTIVITIES AND DS RESEARCH ACTIVITIES CONDUCTED BY ARQULE AND DS, RESPECTIVELY,
DURING THE RESEARCH COLLABORATION PERIOD TO THE EXTENT NOT PREVIOUSLY INCLUDED
IN THE REPORTS DESCRIBED ABOVE.

 

3.5                                 SELECTION OF DS TARGETS.

 

3.5.1                                 INITIAL DS TARGETS.  THE PARTIES HEREBY
ACKNOWLEDGE AND AGREE THAT * (*) TARGETS HAVE BEEN DESIGNATED BY THE PARTIES AS
DS TARGETS AS OF THE EFFECTIVE DATE AND ARE INCLUDED ON THE DS TARGET LIST (THE
“INITIAL DS TARGETS”).

 

3.5.2                                 SUBSTITUTION OF DS TARGETS.

 

(A)                                  DISCONTINUATION AND REPLACEMENT OF DS
TARGETS.  IF, AT ANY TIME DURING THE RESEARCH COLLABORATION PERIOD, DS
DETERMINES THAT IT WISHES TO DISCONTINUE FURTHER RESEARCH WITH RESPECT TO A DS
TARGET (I) DS SHALL PROVIDE WRITTEN NOTICE OF SUCH DETERMINATION TO ARQULE AND
THE JRC, WHICH NOTICE SHALL IDENTIFY THE DS TARGET AND STATE THE REASON FOR SUCH
DETERMINATION; (II) ALL ACTIVITIES (INCLUDING ALL ARQULE RESEARCH ACTIVITIES)
BEING CONDUCTED WITH RESPECT TO SUCH DS TARGET UNDER THE RESEARCH PROGRAM SHALL
PROMPTLY CEASE; AND (III) SUCH DS TARGET SHALL BE DEEMED TO BE AN ABANDONED DS
TARGET AS OF THE DATE OF SUCH WRITTEN NOTICE.

 

(B)                                 DESIGNATION OF BLOCKED TARGETS.  AS SOON AS
PRACTICABLE AND IN ANY EVENT WITHIN * AFTER RECEIPT OF NOTICE PURSUANT TO
SECTION 3.5.2(A), ARQULE SHALL

 

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PROVIDE TO DS A WRITTEN NOTICE INDICATING WHETHER OR NOT THERE ARE ANY BLOCKED
TARGETS; AND IF THERE ARE ANY BLOCKED TARGETS, ARQULE SHALL (I) PROVIDE TO AN
INDEPENDENT THIRD PARTY ATTORNEY IDENTIFIED BY ARQULE AND REASONABLY ACCEPTABLE
TO DS (THE “GATEKEEPER”) A WRITTEN NOTICE IDENTIFYING ALL TARGETS THAT ARE
BLOCKED TARGETS FOR PURPOSES OF THIS AGREEMENT (SUCH NOTICE, THE “BLOCKED TARGET
LIST”) AND (II) PROVIDE DS WITH WRITTEN CONFIRMATION THAT IT HAS PROVIDED THE
BLOCKED TARGET LIST TO THE GATEKEEPER.

 

(C)                                  DESIGNATION OF AVAILABLE TARGETS.  DS MAY,
AT ANY TIME AFTER ITS RECEIPT FROM ARQULE OF THE WRITTEN CONFIRMATION THAT THE
BLOCKED TARGET LIST HAS BEEN PROVIDED TO THE GATEKEEPER, PROPOSE UP TO * (*)
TARGETS THAT DS DESIRES TO INCLUDE AS DS TARGETS AS PART OF THE RESEARCH PROGRAM
(EACH, A “DESIRED TARGET”) BY PROVIDING WRITTEN NOTICE TO THE GATEKEEPER WHICH
NOTICE SHALL IDENTIFY SUCH DESIRED TARGETS (EACH, A “DESIRED TARGET NOTICE”). 
AS SOON AS PRACTICABLE AND IN ANY EVENT WITHIN * (*) DAYS OF THE GATEKEEPER’S
RECEIPT OF A DESIRED TARGET NOTICE, THE GATEKEEPER SHALL PROVIDE DS WITH A
WRITTEN RESPONSE (EACH, AN “AVAILABLE TARGET RESPONSE”) WHICH SHALL IDENTIFY
THOSE DESIRED TARGETS LISTED ON THE DESIRED TARGET NOTICE THAT ARE NOT BLOCKED
TARGETS (EACH SUCH TARGET, AN “AVAILABLE TARGET”) AND THOSE DESIRED TARGETS
LISTED ON THE DESIRED TARGET NOTICE THAT ARE BLOCKED TARGETS.  IN THE EVENT THAT
THE GATEKEEPER IDENTIFIES ONE OR MORE DESIRED TARGETS AS BLOCKED TARGETS IN THE
AVAILABLE TARGET RESPONSE, DS SHALL HAVE THE RIGHT TO PROPOSE ONE (1) ADDITIONAL
DESIRED TARGET IN A DESIRED TARGET NOTICE PURSUANT TO THIS SECTION 3.5.2(C) FOR
EACH SUCH DESIRED TARGET THAT IS IDENTIFIED AS A BLOCKED TARGET UNTIL SUCH TIME
AS AN AGGREGATE OF * (*) AVAILABLE TARGETS HAVE BEEN IDENTIFIED IN THE AVAILABLE
TARGET RESPONSES.  NOTWITHSTANDING THE FOREGOING IN THE EVENT THAT ARQULE
DETERMINES THAT THERE ARE NO BLOCKED TARGETS, IT SHALL PROVIDE DS WITH WRITTEN
NOTICE AND DS SHALL THEREAFTER HAVE THE RIGHT TO PROVIDE THE DESIRED TARGET
NOTICE CONTEMPLATED BY THIS SECTION 3.5.2(C) DIRECTLY TO ARQULE AND ALL DESIRED
TARGETS LISTED ON THE DESIRED TARGET NOTICE SHALL BE DEEMED TO BE AVAILABLE
TARGETS FOR PURPOSES OF THIS AGREEMENT.

 

(D)                                 FEASIBILITY ASSESSMENT ACTIVITIES AND TARGET
REPLACEMENT.  AS SOON AS PRACTICABLE AND IN ANY EVENT WITHIN * OF THE
IDENTIFICATION BY THE GATEKEEPER (OR BY DS IF ARQULE’S NOTICE INDICATES THAT
THERE ARE NO BLOCKED TARGETS) OF * (*) AVAILABLE TARGETS PURSUANT TO
SECTION 3.5.2(C), ARQULE SHALL COMMENCE THE FEASIBILITY

 

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ASSESSMENT ACTIVITIES WITH RESPECT TO SUCH AVAILABLE TARGETS.  AS SOON AS
PRACTICABLE FOLLOWING THE COMPLETION OF SUCH FEASIBILITY ASSESSMENT ACTIVITIES,
ARQULE SHALL PROVIDE DS WITH WRITTEN NOTICE WHICH SHALL IDENTIFY THOSE AVAILABLE
TARGETS THAT ARQULE REASONABLY BELIEVES WOULD BE AMENABLE TO THE APPLICATION OF
THE AKIP PLATFORM TECHNOLOGY (EACH, A “VALIDATED TARGET”).  DS SHALL HAVE THE
RIGHT WITHIN * OF ARQULE’S IDENTIFICATION OF THE VALIDATED TARGETS TO REPLACE
THE ABANDONED DS TARGET WITH ONE OF THE VALIDATED TARGETS BY PROVIDING WRITTEN
NOTICE TO ARQULE, WHICH NOTICE SHALL IDENTIFY SUCH VALIDATED TARGET (EACH, A
“VALIDATED TARGET NOTICE”).  AS SOON AS PRACTICABLE AFTER THE RECEIPT OF SUCH
VALIDATED TARGET NOTICE, (I) SUCH VALIDATED TARGET SHALL BE ADDED TO THE DS
TARGET LIST AND SHALL BE DEEMED TO BE A DS TARGET FOR PURPOSES OF THIS AGREEMENT
AND (II) THE JRC SHALL PREPARE AN UPDATE TO THE ANNUAL RESEARCH PLAN TO IDENTIFY
THE ADVANCEMENT CRITERIA APPLICABLE TO SUCH DS TARGET AND DESCRIBE THE ARQULE
RESEARCH ACTIVITIES TO BE CONDUCTED WITH RESPECT TO SUCH DS TARGET.

 

(E)                                  LIMITATION ON DS TARGETS.  NOTWITHSTANDING
ANYTHING TO THE CONTRARY SET FORTH IN THIS AGREEMENT, DS SHALL HAVE THE RIGHT TO
DESIGNATE AN AGGREGATE OF UP TO * (*) DS TARGETS PURSUANT TO THIS AGREEMENT,
CONSISTING OF (I) THE * (*) INITIAL TARGETS DESIGNATED BY THE PARTIES ON THE
EFFECTIVE DATE AND (II) UP TO * (*) VALIDATED TARGETS DESIGNATED BY DS TO
REPLACE ABANDONED DS TARGETS PURSUANT TO SECTION 3.5.2(D); PROVIDED, THAT, IN
THE EVENT THAT DS DESIGNATES * (*) DS TARGETS (I.E., THE * (*) INITIAL DS
TARGETS AND * (*) VALIDATED TARGETS SELECTED AS REPLACEMENTS) AS ABANDONED DS
TARGETS PURSUANT TO SECTION 3.5.2(D) ON OR BEFORE THE FIRST ANNIVERSARY OF THE
EFFECTIVE DATE, DS SHALL HAVE THE RIGHT TO DESIGNATE AN ADDITIONAL * (*) DS
TARGETS, OR AN AGGREGATE OF UP TO * (*) DS TARGETS, PURSUANT TO THE PROCEDURES
SET FORTH IN THIS SECTION 3.5.2.  FOR CLARITY, IN NO EVENT SHALL ARQULE BE
OBLIGATED TO CONDUCT ARQULE RESEARCH ACTIVITIES ON MORE THAN * (*) DS TARGETS AT
ANY GIVE TIME.

 

3.5.3                                 TERMINATION OF REPLACEMENT RIGHT. 
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, DS’S RIGHT TO
REPLACE DS TARGETS PURSUANT TO SECTION 3.5.2 SHALL TERMINATE ON THE DATE OF
TERMINATION OR EXPIRATION OF THE RESEARCH COLLABORATION PERIOD, UNLESS EXTENDED
BY MUTUAL AGREEMENT OF THE PARTIES.

 

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3.6                                 DESIGNATION AND ADVANCEMENT OF COLLABORATION
COMPOUNDS. DURING THE RESEARCH COLLABORATION PERIOD, EACH PARTY SHALL PROVIDE
THE OTHER PARTY AND THE JRC WITH WRITTEN NOTICE OF ITS IDENTIFICATION IN THE
CONDUCT OF THE RESEARCH PROGRAM OF (A) ANY COLLABORATION COMPOUND THAT SUCH
PARTY REASONABLY BELIEVES HAS AN IC50 LESS THAN *ΜM AGAINST A DS TARGET AND
SATISFIES THE ADVANCEMENT CRITERIA TO ADVANCE TO HIT TO LEAD (A “HIT”), (B) ANY
COLLABORATION COMPOUND THAT SUCH PARTY REASONABLY BELIEVES SHOULD BE ADVANCED,
AND ANY COLLABORATION COMPOUND THAT SUCH PARTY REASONABLY BELIEVES TO SATISFY
THE CRITERIA FOR A PRIMARY DEVELOPMENT COMPOUND WHICH NOTICE SHALL (I) IDENTIFY
THE COLLABORATION COMPOUND WITH ITS CHEMICAL AND BIOLOGICAL DATA, AND
(II) SUMMARIZE BRIEFLY THE RESULTS OF THE NON-CLINICAL STUDIES AND ASSESSMENTS
ON SUCH COLLABORATION COMPOUND COMPLETED BY OR ON BEHALF OF SUCH PARTY UNDER THE
RESEARCH PROGRAM (EACH, A “COLLABORATION COMPOUND NOTICE”). WITHIN * (*) DAYS
AFTER ITS RECEIPT OF EACH SUCH COLLABORATION COMPOUND NOTICE FROM A PARTY
PURSUANT TO THIS SECTION 3.6, THE JRC SHALL REVIEW THE DATA AND INFORMATION AND
DETERMINE WHETHER SUCH COLLABORATION COMPOUND SATISFIES THE MINIMUM REQUIREMENT
AND/OR TO ADVANCE SUCH COLLABORATION COMPOUND TO THE NEXT RESEARCH STAGE AND/OR
TO DESIGNATE SUCH COLLABORATION COMPOUND AS SATISFYING THE CRITERIA FOR
DESIGNATION AS A PRIMARY DEVELOPMENT COMPOUND. ONCE THE JRC HAS DESIGNATED SUCH
COLLABORATION COMPOUND AS SATISFYING THE CRITERIA FOR DESIGNATION AS A PRIMARY
DEVELOPMENT COMPOUND, DS MAY DESIGNATE SUCH COLLABORATION COMPOUND AS A PRIMARY
DEVELOPMENT COMPOUND BY WRITTEN NOTICE TO ARQULE.

 

3.7                                 SUPPLY OF COLLABORATION COMPOUNDS. UNLESS
OTHERWISE AGREED BY THE PARTIES, (A) ARQULE SHALL BE RESPONSIBLE FOR
MANUFACTURING AND PROVIDING COLLABORATION COMPOUNDS FOR USE IN THE RESEARCH
PROGRAM THROUGH THE HIT TO LEAD RESEARCH STAGE, (B) IF (I) THE LEAD OPTIMIZATION
ACTIVITIES ARE DS RESEARCH ACTIVITIES, DS SHALL BE RESPONSIBLE FOR MANUFACTURING
AND PROVIDING ANY COLLABORATION COMPOUNDS DISCOVERED OR IDENTIFIED IN SUCH LEAD
OPTIMIZATION ACTIVITIES FOR USE IN THE RESEARCH PROGRAM IN THE LEAD OPTIMIZATION
RESEARCH STAGE, AND (II) IF THE LEAD OPTIMIZATION ACTIVITIES ARE ARQULE RESEARCH
ACTIVITIES, ARQULE SHALL BE RESPONSIBLE FOR MANUFACTURING AND PROVIDING ANY
COLLABORATION COMPOUNDS DISCOVERED OR IDENTIFIED IN SUCH LEAD OPTIMIZATION
ACTIVITIES FOR USE IN THE RESEARCH PROGRAM IN THE LEAD OPTIMIZATION RESEARCH
STAGE, AND (C) DS SHALL BE RESPONSIBLE FOR MANUFACTURING AND PROVIDING

 

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COLLABORATION COMPOUNDS FOR USE IN THE RESEARCH PROGRAM IN THE PRECLINICAL
STUDIES RESEARCH STAGE AND FOR ANY OTHER RESEARCH, DEVELOPMENT OR
COMMERCIALIZATION ACTIVITIES.

 

3.8                                 SUPPLY OF PROPRIETARY MATERIALS. FROM TIME
TO TIME DURING THE RESEARCH COLLABORATION PERIOD, EITHER PARTY (THE
“TRANSFERRING PARTY”) MAY SUPPLY THE OTHER PARTY (THE “RECIPIENT PARTY”) WITH
PROPRIETARY MATERIALS OF THE TRANSFERRING PARTY FOR USE IN THE RESEARCH PROGRAM.
IN CONNECTION THEREWITH, EACH RECIPIENT PARTY HEREBY AGREES THAT (A) IT SHALL
NOT USE SUCH PROPRIETARY MATERIALS FOR ANY PURPOSE OTHER THAN EXERCISING ITS
RIGHTS OR PERFORMING ITS OBLIGATIONS UNDER THIS AGREEMENT; (B) IT SHALL USE SUCH
PROPRIETARY MATERIALS ONLY IN COMPLIANCE WITH ALL APPLICABLE LAWS; (C) IT SHALL
NOT TRANSFER ANY SUCH PROPRIETARY MATERIALS TO ANY THIRD PARTY WITHOUT THE PRIOR
WRITTEN CONSENT OF THE TRANSFERRING PARTY, EXCEPT AS EXPRESSLY PERMITTED BY THIS
AGREEMENT; (D) THE RECIPIENT PARTY SHALL NOT ACQUIRE ANY RIGHT, TITLE OR
INTEREST IN OR TO SUCH PROPRIETARY MATERIALS AS A RESULT OF SUCH SUPPLY BY THE
TRANSFERRING PARTY; AND (E) UPON THE EXPIRATION OR TERMINATION OF THE RESEARCH
COLLABORATION PERIOD, THE RECIPIENT PARTY SHALL, IF AND AS INSTRUCTED BY THE
TRANSFERRING PARTY, EITHER DESTROY OR RETURN ANY SUCH PROPRIETARY MATERIALS THAT
ARE NOT THE SUBJECT OF THE GRANT OF A CONTINUING LICENSE HEREUNDER.

 

3.9                                 DETERMINATION OF IC50. WHENEVER THIS
AGREEMENT REFERS TO THE IC50 OF A COMPOUND, SUCH IC50 SHALL BE DETERMINED
THROUGH THE APPLICATION OF THE KINASE INHIBITION ASSAYS.

 

3.10                           RESEARCH COLLABORATION PERIOD. THE RESEARCH
PROGRAM SHALL COMMENCE ON THE EFFECTIVE DATE AND CONTINUE UNTIL THE EXPIRATION
OF THE RESEARCH COLLABORATION PERIOD. NOTWITHSTANDING THE FOREGOING, THE
RESEARCH PROGRAM MAY BE TERMINATED PRIOR TO THE EXPIRATION OF THE RESEARCH
COLLABORATION PERIOD (A) BY EITHER PARTY (I) ON * (*) DAYS’ PRIOR WRITTEN NOTICE
TO THE OTHER PARTY AT ANY TIME FOLLOWING THE EXERCISE BY DS OF * (*) DS OPTIONS
OR (II) AT ANY TIME ON OR AFTER THE FIRST ANNIVERSARY OF THE EFFECTIVE DATE, ON
ONE-HUNDRED * (*) DAYS’ PRIOR WRITTEN NOTICE TO THE OTHER PARTY IF ALL DS
TARGETS THAT ARE INCLUDED IN THE RESEARCH PROGRAM HAVE BEEN DISCONTINUED BY DS;
AND (B) BY DS AT ANY TIME ON OR AFTER THE FIRST ANNIVERSARY OF THE EFFECTIVE
DATE UPON NOT LESS THAN ONE HUNDRED * (*) DAYS’ PRIOR WRITTEN NOTICE TO ARQULE.

 

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4.                                      DEVELOPMENT PROGRAM; COMMERCIALIZATION

OF LICENSED PRODUCTS

 

4.1                                 OBJECTIVES OF THE DEVELOPMENT PROGRAM. THE
OBJECTIVES OF THE DEVELOPMENT PROGRAM SHALL BE THE DEVELOPMENT AND
COMMERCIALIZATION OF LICENSED PRODUCTS IN THE FIELD AND IN THE TERRITORY.

 

4.2                                 RESPONSIBILITY FOR DEVELOPMENT AND
COMMERCIALIZATION OF LICENSED PRODUCTS. EXCEPT FOR ANY DEVELOPMENT ACTIVITIES
THAT DS AND ARQULE MUTUALLY AGREE SHOULD BE UNDERTAKEN BY ARQULE (WHICH SHALL BE
PAID FOR BY DS AT THE FTE RATE), DS SHALL HAVE THE SOLE RIGHT AND
RESPONSIBILITY, INCLUDING THE RIGHT TO MAKE ANY DECISION AT ITS SOLE DISCRETION,
AT ITS SOLE EXPENSE, FOR ALL ASPECTS OF THE DEVELOPMENT OF LICENSED PRODUCTS,
AND, SUBJECT TO THE ARQULE CO-COMMERCIALIZATION OPTION, ALL ASPECTS OF THE
COMMERCIALIZATION OF LICENSED PRODUCTS, IN THE FIELD IN THE TERRITORY,
INCLUDING, WITHOUT LIMITATION, THE CONDUCT OF: (A) ALL IND-ENABLING NON-CLINICAL
STUDIES THAT ARE OUTSIDE OF THE RESEARCH PROGRAM; (B) ALL ACTIVITIES RELATED TO
HUMAN CLINICAL TRIALS (INCLUDING, WITHOUT LIMITATION, PHASE I CLINICAL TRIALS,
PHASE II CLINICAL TRIALS AND PHASE III CLINICAL TRIALS); (C) ALL ACTIVITIES
RELATING TO THE MANUFACTURE AND SUPPLY OF LICENSED PRODUCTS (INCLUDING ALL
REQUIRED PROCESS DEVELOPMENT AND SCALE UP WORK WITH RESPECT THERETO); AND
(D) ALL PRE-MARKETING, MARKETING, PROMOTION, SALES, DISTRIBUTION, IMPORT AND
EXPORT ACTIVITIES (INCLUDING SECURING REIMBURSEMENT, CONDUCTING SALES AND
MARKETING ACTIVITIES AND ANY POST-MARKETING TRIALS OR POST-MARKETING SAFETY
SURVEILLANCE AND MAINTAINING DATABASES). WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, DS SHALL HAVE THE SOLE RIGHT AND RESPONSIBILITY, AT ITS SOLE EXPENSE,
(I) TO MAKE ALL REGULATORY FILINGS FOR LICENSED PRODUCTS AND FILE ALL DRUG
APPROVAL APPLICATIONS AND OTHERWISE SEEK ALL REGULATORY APPROVALS FOR LICENSED
PRODUCTS, AS WELL AS TO CONDUCT ALL CORRESPONDENCE AND COMMUNICATIONS WITH
REGULATORY AUTHORITIES REGARDING SUCH MATTERS, SUBJECT IN EACH CASE TO
SECTION 4.10.2, (II) TO REPORT ALL ADVERSE EVENTS TO REGULATORY AUTHORITIES IF
AND TO THE EXTENT REQUIRED BY APPLICABLE LAWS, AND (III) TO CEASE FURTHER
DEVELOPMENT AND/OR COMMERCIALIZATION OF LICENSED PRODUCTS AND TO DEVELOP AND
COMMERCIALIZE BACKUP COMPOUNDS AS LICENSED PRODUCTS. ALL REGULATORY APPROVALS
FOR LICENSED PRODUCTS SHALL BE OWNED BY DS, SUBJECT TO SECTION 10.3.

 

4.3                                 DEVELOPMENT PLANS. AN INITIAL DEVELOPMENT
PLAN FOR EACH LICENSED PRODUCT SHALL BE PREPARED BY DS AND SUBMITTED TO THE JEC
FOR ITS REVIEW WITHIN * (*) DAYS OF THE DATE OF

 

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EXERCISE BY DS OF EACH DS OPTION, AND IN ANY EVENT ON OR PRIOR TO THE INITIATION
OF DEVELOPMENT ACTIVITIES WITH RESPECT THERETO, WHICH SHALL DESCRIBE THE
DEVELOPMENT ACTIVITIES TO BE CONDUCTED. ARQULE MAY PROVIDE INPUT ON THE
DEVELOPMENT PLAN AND DS WILL GIVE GOOD FAITH CONSIDERATION TO SUCH INPUT. EACH
AMENDMENT OR MODIFICATION OF EACH DEVELOPMENT PLAN FOR EACH LICENSED PRODUCT
THAT IS PREPARED BY DS SHALL BE SUBMITTED TO THE JEC MEMBERS FOR ITS REVIEW
WITHIN * (*) DAYS AFTER IT IS PREPARED. ARQULE MAY PROVIDE INPUT ON AMENDMENTS
AND MODIFICATIONS TO THE DEVELOPMENT PLAN AND DS WILL GIVE GOOD FAITH
CONSIDERATION TO SUCH INPUT.

 

4.4                                 COMMERCIAL ASSESSMENT. PRIOR TO COMMENCING
ANY PHASE II CLINICAL TRIAL OR PHASE III CLINICAL TRIAL OF ANY LICENSED PRODUCT,
DS WILL PERFORM A COMMERCIAL ASSESSMENT OF THE MARKET OPPORTUNITIES IN VARIOUS
INDICATIONS FOR SUCH LICENSED PRODUCT THROUGHOUT THE TERRITORY (WHICH MAY BE
PERFORMED BY INTERNAL PERSONNEL OR EXTERNAL CONSULTANTS) AND WILL PROVIDE A COPY
THEREOF TO ARQULE WITHIN * (*) DAYS AFTER THE COMPLETION THEREOF.

 

4.5                                 LICENSED PRODUCT COMMERCIALIZATION PLANS.
WITHIN ONE HUNDRED AND EIGHTY (180) DAYS AFTER THE INITIATION OF A PHASE III
CLINICAL TRIAL WITH RESPECT TO EACH LICENSED PRODUCT, DS SHALL PREPARE AND
PROVIDE TO THE JEC FOR ITS REVIEW A LICENSED PRODUCT COMMERCIALIZATION PLAN FOR
EACH SUCH LICENSED PRODUCT, AND SHALL INFORM THE JEC WITH RESPECT TO ALL
SIGNIFICANT COMMERCIALIZATION DECISIONS TO BE MADE WITH RESPECT TO SUCH LICENSED
PRODUCT. ARQULE MAY PROVIDE INPUT ON THE LICENSED PRODUCT COMMERCIALIZATION PLAN
AND DS WILL GIVE GOOD FAITH CONSIDERATION TO SUCH INPUT.

 

4.6                                 MANUFACTURE AND SUPPLY OF LICENSED PRODUCTS.
UNLESS OTHERWISE AGREED TO BY THE PARTIES, DS SHALL BE RESPONSIBLE, AT ITS SOLE
EXPENSE, FOR MANUFACTURING, EITHER BY ITSELF, ITS AFFILIATES OR BY A THIRD PARTY
CONTRACT MANUFACTURING ORGANIZATION, EACH LICENSED PRODUCT THAT IS DEVELOPED AND
COMMERCIALIZED UNDER THIS AGREEMENT. DS SHALL REPORT REGULARLY TO THE JEC ON CMC
PLANS AND ACTIVITIES, DEVELOPMENT OF MANUFACTURING PROCESSES AND ANY PLANS FOR
OUTSOURCING (INCLUDING THE IDENTITY OF ANY THIRD PARTY TO WHICH ANY PART OF
MANUFACTURE OF LICENSED PRODUCTS IS OUTSOURCED.)

 

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4.7                                 DEVELOPMENT AND COMMERCIALIZATION DILIGENCE.

 

(A)                                  DILIGENCE OBLIGATIONS. DS SHALL EXERCISE
COMMERCIALLY REASONABLE EFFORTS DURING THE TERM TO CONDUCT THE DS DEVELOPMENT
ACTIVITIES, AND TO DEVELOP AND COMMERCIALIZE LICENSED PRODUCTS TARGETED AT EACH
DS TARGET IN THE FIELD AND IN THE TERRITORY.

 

(B)                                 EFFECT OF BREACH OF DILIGENCE OBLIGATIONS.
IF ARQULE AT ANY TIME REASONABLY BELIEVES THAT DS, ON A LICENSED
PRODUCT-BY-LICENSED PRODUCT BASIS, IS NOT MEETING ITS DILIGENCE OBLIGATIONS
PURSUANT TO SECTION 4.7(A), ARQULE MAY GIVE WRITTEN NOTICE TO DS IN THE FORM OF
DETAILED REASONS THAT WOULD SUPPORT THE PROPOSITION THAT DS IS NOT MEETING SUCH
DILIGENCE OBLIGATION AND PROPOSED ACTIVITIES THAT WOULD SATISFY THE DILIGENCE
REQUIREMENT. IN SUCH EVENT, DS SHALL PROVIDE SUCH WRITTEN JUSTIFICATION AND/OR
PROPOSED PLANS FOR CURING THE ALLEGED BREACH TO ARQULE RESPONDING TO THE ISSUES
RAISED BY ARQULE WITHIN * AFTER SUCH NOTICE IS GIVEN. IF ARQULE AGREES THAT THE
PLAN PROPOSED BY DS WILL COMPLETELY CURE THE ALLEGED BREACH, DS SHALL HAVE * TO
BEGIN IMPLEMENTING SUCH PLAN. IN THE EVENT THAT ARQULE DOES NOT RECEIVE SUCH
JUSTIFICATION WITHIN SUCH *, DOES NOT AGREE WITH SUCH JUSTIFICATION, OR DS HAS
NOT BEGUN IMPLEMENTING ITS PLAN TO CURE THE ALLEGED BREACH WITHIN * OF RECEIVING
AGREEMENT FROM ARQULE, THEN ARQULE MAY SUBMIT ANY UNRESOLVED MATTERS FOR FULL
ARBITRATION UNDER SECTION 13.1.1. IF THE ARBITRATOR RESOLVES ANY UNRESOLVED
MATTERS IN FAVOR OF ARQULE, ARQULE SHALL HAVE THE RIGHT TO TREAT SUCH FINDING AS
A BREACH OF SECTION 4.7(A) AND TAKE ACTION TO TERMINATE THE LICENSE WITH RESPECT
TO SUCH DS TARGET AND/OR LICENSED PRODUCT IN ACCORDANCE WITH SECTION 10.2.2
WITHOUT FURTHER ARBITRATION.

 

4.8                                 COMPLIANCE. DS SHALL PERFORM DS DEVELOPMENT
ACTIVITIES (AND IF DS AND ARQULE AGREE THAT ARQULE SHALL PERFORM ANY DEVELOPMENT
ACTIVITIES, ARQULE SHALL PERFORM SUCH ACTIVITIES) IN GOOD SCIENTIFIC MANNER AND
IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH ALL APPLICABLE LAWS. FOR PURPOSES OF
CLARITY, WITH RESPECT TO SUCH DEVELOPMENT ACTIVITIES THAT WILL OR WOULD
REASONABLY BE EXPECTED TO GENERATE DATA TO BE SUBMITTED TO A REGULATORY
AUTHORITY IN SUPPORT OF A REGULATORY FILING OR DRUG APPROVAL APPLICATION, THE
PARTY PERFORMING SUCH ACTIVITY SHALL COMPLY IN ALL MATERIAL RESPECTS WITH, IF
AND AS APPLICABLE, THE REGULATIONS AND

 

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GUIDANCE OF THE FDA THAT CONSTITUTE GOOD LABORATORY PRACTICE, GOOD MANUFACTURING
PRACTICE OR GOOD CLINICAL PRACTICES (OR, IF AND AS APPROPRIATE UNDER THE
CIRCUMSTANCES, INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH) GUIDANCE OR OTHER
COMPARABLE REGULATION AND GUIDANCE OF ANY REGULATORY AUTHORITY IN ANY COUNTRY OR
REGION IN THE TERRITORY). EACH PARTY SHALL BE SOLELY RESPONSIBLE FOR PAYING THE
SALARIES AND BENEFITS OF ITS EMPLOYEES CONDUCTING ITS DEVELOPMENT ACTIVITIES.

 

4.9                                 EXCHANGE OF REPORTS; INFORMATION; UPDATES.

 

4.9.1                        DEVELOPMENT PROGRAM REPORTS. DS SHALL KEEP THE JEC
REGULARLY INFORMED OF THE PROGRESS OF ITS EFFORTS TO DEVELOP LICENSED PRODUCTS
IN THE FIELD AND IN THE TERRITORY. WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, DS SHALL, AT LEAST ONCE EACH SIX (6) MONTHS OF EACH CALENDAR YEAR,
PROVIDE THE JEC WITH REPORTS IN REASONABLE DETAIL REGARDING THE STATUS OF ALL
PRECLINICAL IND-ENABLING STUDIES AND ACTIVITIES (INCLUDING TOXICOLOGY AND
PHARMACOKINETIC STUDIES), CLINICAL TRIALS AND OTHER ACTIVITIES CONDUCTED UNDER
THE DEVELOPMENT PROGRAM. IN ADDITION, DS SHALL DESIGNATE A SENIOR MEMBER OF ITS
DEVELOPMENT ORGANIZATION (WHO MAY BE THE DS ALLIANCE MANAGER IF THE DS ALLIANCE
MANAGER IS A SENIOR MEMBER OF THE DS DEVELOPMENT ORGANIZATION) WITH
RESPONSIBILITY FOR THE DEVELOPMENT OF LICENSED PRODUCTS TO ACT AS A LIAISON WITH
ARQULE AND WHO SHALL RESPOND TO INQUIRIES FROM ARQULE ON DEVELOPMENT ACTIVITIES
AND PROGRESS.

 

4.9.2                        COMMERCIALIZATION REPORTS. DS SHALL KEEP THE JEC
REGULARLY INFORMED OF THE PROGRESS OF DS’S EFFORTS TO COMMERCIALIZE LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY THROUGH PERIODIC UPDATES. WITHOUT
LIMITING THE GENERALITY OF THE FOREGOING, DS SHALL PROVIDE THE JEC WITH ANNUAL
WRITTEN UPDATES TO EACH LICENSED PRODUCT COMMERCIALIZATION PLAN, WHICH SHALL
(A) SUMMARIZE DS’S EFFORTS TO COMMERCIALIZE LICENSED PRODUCTS, (B) IDENTIFY THE
REGULATORY FILINGS AND DRUG APPROVAL APPLICATIONS WITH RESPECT TO SUCH LICENSED
PRODUCT THAT DS OR ANY OF ITS AFFILIATES OR SUBLICENSEES HAVE FILED, SOUGHT OR
OBTAINED IN THE PRIOR TWELVE (12) MONTH PERIOD OR REASONABLY EXPECT TO MAKE,
SEEK OR ATTEMPT TO OBTAIN IN THE FOLLOWING TWELVE (12) MONTH PERIOD AND
(C) SUMMARIZE ALL CLINICAL AND OTHER DATA GENERATED BY DS WITH RESPECT TO
LICENSED PRODUCTS. IN ADDITION, DS SHALL PROVIDE SUCH ADDITIONAL INFORMATION
THAT IT HAS IN ITS POSSESSION

 

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AS MAY BE REASONABLY REQUESTED BY ARQULE REGARDING THE COMMERCIALIZATION OF ANY
LICENSED PRODUCT, WHICH REQUEST SHALL NOT BE MADE MORE THAN ONCE EACH CALENDAR
YEAR.

 

4.9.3                        REVIEW OF REGULATORY FILINGS AND CORRESPONDENCE.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ARQULE SHALL HAVE
THE RIGHT, UPON WRITTEN NOTICE, TO REVIEW ALL REGULATORY FILINGS MADE BY DS AND
ALL CORRESPONDENCE BETWEEN DS AND REGULATORY AUTHORITIES AT ARQULE’S SOLE
EXPENSE.

 

4.10                           DEVELOPMENT AND COMMERCIALIZATION RIGHTS AND
RESTRICTIONS.

 

4.10.1                  DEVELOPMENT AND COMMERCIALIZATION RIGHTS IN THE FIELD.
EXCEPT AS PROVIDED IN SECTION 4.10.2, DS SHALL HAVE THE EXCLUSIVE RIGHT AND
RESPONSIBILITY, AT ITS SOLE COST AND EXPENSE, DURING THE TERM TO DEVELOP
LICENSED PRODUCTS AND COMMERCIALIZE LICENSED PRODUCTS IN THE TERRITORY FOR USE
IN THE FIELD.

 

4.10.2                  CO-COMMERCIALIZATION RIGHT.

 

(A)                                  CO-COMMERCIALIZATION OPTION.

 

(I)                                     NOTICE OF PHASE III TRIAL. DS SHALL GIVE
ARQULE WRITTEN NOTICE OF ITS INTENT TO INITIATE THE FIRST PHASE III CLINICAL
TRIAL OF EACH LICENSED PRODUCT AT LEAST * (*) DAYS PRIOR TO THE ANTICIPATED DATE
OF SUCH INITIATION.

 

(II)                                  EXERCISE OF CO-COMMERCIALIZATION OPTION.
ARQULE SHALL HAVE THE OPTION (THE “CO-COMMERCIALIZATION OPTION”), IN ITS SOLE
DISCRETION, TO CO-COMMERCIALIZE ANY LICENSED PRODUCT IN THE CO-COMMERCIALIZATION
TERRITORY BY PROVIDING WRITTEN NOTICE TO DS (THE “CO-COMMERCIALIZATION OPTION
NOTICE”) AT ANY TIME DURING THE CO-COMMERCIALIZATION OPTION PERIOD, WHICH NOTICE
SHALL IDENTIFY THE LICENSED PRODUCT (EACH, SUCH LICENSED PRODUCT, A
“CO-COMMERCIALIZED LICENSED PRODUCT”). IF ARQULE EXERCISES ITS
CO-COMMERCIALIZATION OPTION WITH RESPECT TO ANY LICENSED PRODUCT, (A) SUCH
LICENSED PRODUCT WILL BE DEEMED TO BE A CO-COMMERCIALIZED LICENSED PRODUCT FOR
PURPOSES OF THIS AGREEMENT, AND (B) THE PARTIES SHALL (1) NEGOTIATE A
CO-COMMERCIALIZATION AGREEMENT FOR SUCH CO-COMMERCIALIZED LICENSED PRODUCT IN
ACCORDANCE WITH SECTION 4.10.2(A)(III) AND (2) FORM, AS

 

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SOON AS PRACTICABLE THEREAFTER BUT IN ANY EVENT WITHIN * (*) DAYS, THE US
CO-COMMERCIALIZATION COMMITTEE IN ACCORDANCE WITH SECTION 2.3.

 

(III)                               NEGOTIATION OF CO-COMMERCIALIZATION
AGREEMENT.

 

(A)                              Preparation, Negotiation, Execution and
Delivery. Within * (*) days after ARQULE provides a Co-Commercialization Option
Notice, the Parties shall commence the preparation of a co-commercialization
agreement (the “Co-Commercialization Agreement”) which shall provide for the
terms applicable to such Co-Commercialization and shall contain the provisions
set forth below and such additional provisions as are usual and customary for
inclusion in a co-commercialization agreement between companies in the
pharmaceutical industry of comparable sizes to the respective Parties. The
Parties hereby acknowledge and agree that the Co-Commercialization Agreement
shall provide that (1) the Parties shall share Co-Commercialization Activities
with respect to such Co-Commercialized Licensed Product in the
Co-Commercialization Territory with ARQULE providing, at its option, up to *
percent (*%) of all required Primary Detail Equivalents, but in no event will
the total number of sales representatives of ARQULE exceed * (*), unless
otherwise set forth in the Co-Commercialization Agreement, pursuant to the
Co-Commercialization Plan; (2) DS shall be responsible for all account
management of community, academic and Veterans hospitals and associated
activities, including, but not limited to, communication with hospital pharmacy
and the pharmacy and therapeutics committee, formulary management and
contracting; (3) DS shall reimburse ARQULE for the fully-burdened cost incurred
by ARQULE’s sales representatives who engaged in conducting such
Co-Commercialization Activities at a negotiated rate comparable to the then
prevailing rate, but in no event shall such rate be in excess of the fully
burdened cost to DS of employing or otherwise engaging its own representatives
who detail its oncology products in the Co-Commercialization Territory
(including incentive compensation for the ARQULE sales personnel on the same
basis as the incentive compensation of DS personnel in the Co-Commercialization
Territory); (4) such ARQULE sales personnel shall engage in Detailing the
Co-Commercialized Licensed Product and any other product being co-promoted by
ARQULE and DS in the first position, but shall not expend more than * percent
(*%) of the detailing effort on any other products unless the Parties

 

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agree, and shall not promote any other product that is directly competitive with
the Co-Commercialized Licensed Product or any other product of DS; provided,
that in the event ARQULE’s sales personnel promote any product that is not being
co-promoted by ARQULE and DS, there shall be a reduction in DS’s reimbursement
of ARQULE’s cost that is proportional to the percentage of detailing effort
expended on products that are not being co-promoted by ARQULE and DS; (5) the
Parties shall create a US Co-Commercialization Committee in accordance with
Section 2.3; and (6) the Parties shall cooperate to allocate Details between
them in good faith, taking into account geography, settings, provider category
and Detailing position, as well as ARQULE’s sales force composition. Disputes
shall be decided by the chair of the USCC. The Parties shall negotiate the
Co-Commercialization Agreement in good faith and with sufficient diligence as is
required to execute and deliver the Co-Commercialization Agreement within * (*)
days after ARQULE provides the Co-Commercialization Option Notice.

 

(B)                                Dispute Resolution. In the event the Parties
fail to execute and deliver the Co-Commercialization Agreement within the * (*)
day period described in Section 4.10.2(a)(iii), the Parties shall (1) use
reasonable efforts to complete such negotiations and to execute and deliver the
Co-Commercialization Agreement as soon as possible after such * (*) day period
and (2) without limiting the generality of the foregoing, after the expiration
of such * (*) day period, each produce a list of issues on which they have
failed to reach agreement and submit its list to the JEC to be resolved in
accordance with Section 2.1.5.

 

(B)                                 CO-COMMERCIALIZATION PLAN. AS SOON AS
PRACTICABLE FOLLOWING THE EXERCISE BY ARQULE OF A CO-COMMERCIALIZATION OPTION
NOTICE, DS SHALL PREPARE AND PROVIDE TO THE USCC FOR ITS REVIEW A
CO-COMMERCIALIZATION PLAN (THE “CO-COMMERCIALIZATION PLAN”) FOR EACH
CO-COMMERCIALIZED LICENSED PRODUCT FOR THE CO-COMMERCIALIZATION TERRITORY  DS
SHALL UPDATE THE CO-COMMERCIALIZATION PLAN TO THE USCC NOT LESS THAN ANNUALLY.
EACH AMENDMENT OR MODIFICATION OF EACH CO-COMMERCIALIZATION PLAN FOR EACH
LICENSED PRODUCT THAT IS  PREPARED BY DS SHALL BE SUBMITTED TO THE USCC FOR ITS
REVIEW WITHIN * (*) DAYS AFTER IT IS PREPARED. ARQULE MAY PROVIDE INPUT ON THE
CO-COMMERCIALIZATION PLAN AND ANY AMENDMENT OR MODIFICATION  AND DS WILL GIVE
GOOD FAITH CONSIDERATION TO SUCH INPUT.

 

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(C)                                  LABELING.  ALL PRODUCT LABELS FOR
CO-COMMERCIALIZED LICENSED PRODUCTS SHALL INCLUDE, IN EQUAL PROMINENCE, THE
NAMES OF BOTH DS AND ARQULE.  THE USCC SHALL HAVE THE RESPONSIBILITY OF MEETING
NOT LESS FREQUENTLY THAN ANNUALLY AND DECIDING WHETHER CHANGES IN THE PARTICULAR
APPEARANCE IN LABELING OF PACKAGING AND CONTAINERS OF CO-COMMERCIALIZED LICENSED
PRODUCTS OR IN THE PRODUCT INFORMATION ARE REQUIRED.

 

(D)                                 COOPERATION; ADDITIONAL INFORMATION.  IN
CONNECTION WITH ARQULE’S CONSIDERATION OF THE EXERCISE OF A CO-COMMERCIALIZATION
OPTION WITH RESPECT TO EACH LICENSED PRODUCT, DS SHALL PROVIDE ARQULE WITH ANY
INFORMATION CONTROLLED BY DS AND REASONABLY REQUESTED BY ARQULE THAT IS
NECESSARY OR USEFUL TO ARQULE IN DETERMINING WHETHER TO EXERCISE SUCH
CO-COMMERCIALIZATION OPTION.

 

4.11                           EXPANSION OF THE FIELD.  IF AT ANY TIME DURING
THE TERM OF THIS AGREEMENT, DS DESIRES TO ADD AN ADDITIONAL INDICATION TO THE
FIELD WITH RESPECT TO A LICENSED PRODUCT FOR PURPOSES OF THIS AGREEMENT (EACH,
AN “ADDITIONAL INDICATION”), DS SHALL GIVE WRITTEN NOTICE TO ARQULE SPECIFYING
SUCH LICENSED PRODUCT AND SUCH ADDITIONAL INDICATION OR ADDITIONAL INDICATIONS
(THE “ADDITIONAL INDICATION NOTICE”).  ARQULE SHALL, ON OR BEFORE * (*) DAYS
FROM THE DATE OF THE ADDITIONAL INDICATION NOTICE, PROVIDE DS WITH A WRITTEN
RESPONSE AS TO WHETHER OR NOT IT CONTROLS THE TECHNOLOGY AND PATENT RIGHTS
APPLICABLE TO SUCH LICENSED PRODUCT FOR SUCH ADDITIONAL INDICATION.  IF ARQULE
CONTROLS THE TECHNOLOGY AND PATENT RIGHTS TO SUCH LICENSED PRODUCT FOR SUCH
ADDITIONAL INDICATION, THE PARTIES SHALL FOR A PERIOD OF * (*) DAYS FROM THE
DATE DS RECEIVES THE WRITTEN NOTICE FROM ARQULE NEGOTIATE IN GOOD FAITH TO
COMPLETE AND EXECUTE ANY AMENDMENT TO THIS AGREEMENT THAT MAY BE REQUIRED TO ADD
THE ADDITIONAL INDICATION OR ADDITIONAL INDICATIONS TO THE DEFINITION OF FIELD
FOR PURPOSES OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, THE INCLUSION OF
ANY AMENDMENTS TO THE APPLICABLE ANNUAL RESEARCH PLANS, AS WELL AS ANY
AMENDMENTS TO THE COMPENSATION PAYABLE BY DS PURSUANT TO ARTICLE 5, THAT MAY BE
REQUIRED TO INCLUDE SUCH ADDITIONAL INDICATION IN THE FIELD, PROVIDED, IF ANY
ADDITIONAL INDICATION IS ADDED TO THE FIELD, THE ROYALTIES FOR SUCH ADDITIONAL
INDICATION WILL BE THE SAME AS FOR OTHER INDICATIONS AND SUCH ADDITIONAL
INDICATION WILL BE INCLUDED IN THE DETERMINATION OF ACHIEVEMENT OF MILESTONES
SUBJECT TO MILESTONE PAYMENTS; PROVIDED, THAT, ONLY ONE (1) FULL SET OF THE
MILESTONES TO BE NEGOTIATED PURSUANT TO SECTION 5.4 WILL BE PAID FOR EACH
LICENSED PRODUCT.  IF THE PARTIES ARE UNABLE TO AGREE UPON TERMS AND CONDITIONS
OF SUCH AMENDMENT ON OR BEFORE EXPIRATION

 

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OF SUCH * (*) DAY PERIOD DESPITE THEIR RESPECTIVE GOOD FAITH EFFORTS, THEN THE
PARTIES SHALL REFER SUCH MATTER TO JEC FOR RESOLUTION; PROVIDED THAT IF THE JEC
IS UNABLE TO RESOLVE THE MATTER IT WILL BE REFERRED TO THE DESIGNATED SENIOR
OFFICERS.

 

5.                                      COMPENSATION

 

5.1                                 UPFRONT FEE.  DS SHALL PAY ARQULE A
NON-REFUNDABLE, NON-CREDITABLE UP-FRONT FEE (THE “UPFRONT FEE”) IN THE AGGREGATE
AMOUNT OF FIFTEEN MILLION DOLLARS (U.S. $15,000,000), PAYABLE BY WIRE TRANSFER
OF IMMEDIATELY AVAILABLE FUNDS WITHIN FIVE (5) BUSINESS DAYS OF THE EFFECTIVE
DATE IN ACCORDANCE WITH WIRE TRANSFER INSTRUCTIONS PROVIDED IN WRITING BY ARQULE
PRIOR TO THE EFFECTIVE DATE.

 

5.2                                 LICENSE FEE.  FOR EACH DS OPTION EXERCISED
BY DS PURSUANT TO SECTION 7.1, DS SHALL PAY ARQULE A LICENSE FEE (THE “LICENSE
FEE”) IN THE AMOUNT OF * DOLLARS (US $*), OF WHICH * DOLLARS (US $*) SHALL BE
PAID WITHIN * (*) DAYS OF THE EXECUTION OF THE LICENSE AGREEMENT FOR THE PRIMARY
DEVELOPMENT COMPOUND AND RELATED BACKUP COMPOUNDS THAT WERE THE SUBJECT OF SUCH
DS OPTION, AND * DOLLARS (US $*) SHALL BE PAID WITHIN * (*) DAYS OF THE
INITIATION OF THE FIRST PHASE II CLINICAL TRIAL OF ANY LICENSED PRODUCT UNDER
SUCH LICENSE AGREEMENT.

 

5.3                                 RESEARCH FUNDING.

 

5.3.1                                 PAYMENT OF RESEARCH FUNDING.  IN
CONSIDERATION OF THE PERFORMANCE BY ARQULE OF THE ARQULE RESEARCH ACTIVITIES
UNDER THE RESEARCH PROGRAM AS DESCRIBED IN SECTION 3.3, DURING THE RESEARCH
PROGRAM PERIOD, DS WILL PAY ARQULE THE APPLICABLE QUARTERLY FTE PAYMENT AT LEAST
* (*) DAYS PRIOR TO THE FIRST DAY OF EACH CALENDAR QUARTER, PROVIDED THAT DS
WILL PAY ARQULE THE QUARTERLY FTE PAYMENT COVERING THE PERIOD FROM THE EFFECTIVE
DATE THROUGH THE END OF THE FIRST FULL CALENDAR QUARTER OF THE RESEARCH
COLLABORATION PERIOD WITHIN * (*) DAYS AFTER THE EFFECTIVE DATE.

 

5.3.2                                 EXTERNAL COSTS.  EACH OF ARQULE AND DS
SHALL BE SOLELY RESPONSIBLE FOR THE PAYMENT OF ALL THIRD PARTY RESEARCH ACTIVITY
COSTS (“THIRD PARTY COSTS”), INCLUDING, WITHOUT LIMITATION, CONTRACT RESEARCH
ORGANIZATIONS, CONTRACT PERSONNEL AND CONSULTANT COSTS IT

 

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INCURS TO MEET ITS OBLIGATIONS UNDER AN ANNUAL RESEARCH PLAN; PROVIDED THAT IF
THE EXTERNAL COSTS INCURRED BY ARQULE FOR SELECTIVITY SCREENING FOR ANY DS
TARGET EXCEED * DOLLARS ($*) OR THE TOTAL AMOUNT REQUIRED TO BE EXPENDED FOR
SELECTIVITY SCREENING BY ARQULE EXCEEDS * DOLLARS ($*), THEN ARQULE WILL NOTIFY
DS AND THE PARTIES SHALL DISCUSS THE PLAN FOR ANY ADDITIONAL SELECTIVITY
SCREENING; PROVIDED THAT ARQULE SHALL NOT BE REQUIRED TO PERFORM ANY FURTHER
SELECTIVITY SCREENING.

 

5.4                                 MILESTONE AND ROYALTY PAYMENTS.  THE PARTIES
HEREBY AGREE, AS PROMPTLY AS POSSIBLE ON AND AFTER THE EFFECTIVE DATE, TO
NEGOTIATE IN GOOD FAITH AND REACH AGREEMENT ON AN AMENDMENT TO THIS AGREEMENT OR
A SEPARATE AGREEMENT TO BE EXECUTED BY THE PARTIES WHICH SHALL INCLUDE (A) THE
DEVELOPMENT MILESTONE PAYMENTS, TIERED SALES MILESTONES AND TIERED ROYALTIES ON
NET SALES CUSTOMARY FOR SUCH AGREEMENTS AND TO BE PAID BY DS UNDER THE LICENSE
AGREEMENT(S) FOR EACH LICENSED PRODUCT THAT IS DEVELOPED AND COMMERCIALIZED
UNDER THIS AGREEMENT AND/OR A LICENSE AGREEMENT, WHICH MILESTONE PAYMENTS AND
ROYALTIES SHALL INCLUDE THE MILESTONE AND ROYALTY PAYMENTS DESCRIBED IN SCHEDULE
3 AND SHALL CONFORM IN ALL MATERIAL RESPECTS WITH THE TERMS AND CONDITIONS SET
FORTH IN SCHEDULE 3, AND (B) SUCH ADDITIONAL PROVISIONS RELATING TO ROYALTY
REPORTS, PAYMENT MECHANISMS AND DATES, AUDIT RIGHTS, OVERDUE PAYMENTS, TAXES,
CURRENCY CONVERSION RATES AND OTHER PROVISIONS AS ARE USUAL AND CUSTOMARY FOR
INCLUSION IN PROVISIONS RELATING TO MILESTONES AND ROYALTIES IN COLLABORATION
AND LICENSE AGREEMENTS BETWEEN COMPANIES IN THE PHARMACEUTICAL INDUSTRY OF
COMPARABLE SIZES TO THE RESPECTIVE PARTIES.  FOR PURPOSES OF CLARITY, SUCH
ADDITIONAL PROVISIONS SHALL SUPPLEMENT AND SHALL NOT MATERIALLY EXPAND, LIMIT OR
CHANGE THE PROVISIONS SET FORTH ON SCHEDULE 3.  THE PARTIES SHALL NEGOTIATE SUCH
AMENDMENT TO THIS AGREEMENT OR SEPARATE AGREEMENT IN GOOD FAITH AND WITH
SUFFICIENT DILIGENCE AS IS REQUIRED TO EXECUTE AND DELIVER SUCH AMENDMENT OR
SEPARATE AGREEMENT WITHIN * (*) DAYS OF THE EFFECTIVE DATE.  IN THE EVENT THE
PARTIES FAIL TO EXECUTE AND DELIVER THE AMENDMENT TO THIS AGREEMENT OR SEPARATE
AGREEMENT WITHIN SUCH * (*) DAY PERIOD, THE PARTIES SHALL (A) USE REASONABLE
EFFORTS TO COMPLETE SUCH NEGOTIATIONS AND TO EXECUTE AND DELIVER THE AMENDMENT
TO THIS AGREEMENT OR SEPARATE AGREEMENT AS SOON AS POSSIBLE AFTER SUCH * (*) DAY
PERIOD AND (B) WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, AFTER THE
EXPIRATION OF SUCH * (*) DAY PERIOD, EACH PRODUCE A LIST OF

 

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ISSUES ON WHICH THEY HAVE FAILED TO REACH AGREEMENT AND SUBMIT ITS LIST TO THE
JEC TO BE RESOLVED AS A UNANIMOUS DECISION IN ACCORDANCE WITH SECTION 2.1.5.

 

6.                                      TREATMENT OF CONFIDENTIAL INFORMATION;

PUBLICITY; NON-SOLICITATION.

 

6.1                                 CONFIDENTIALITY.

 

6.1.1                                 CONFIDENTIALITY OBLIGATIONS.  ARQULE AND
DS EACH RECOGNIZE THAT THE OTHER PARTY’S CONFIDENTIAL INFORMATION AND
PROPRIETARY MATERIALS CONSTITUTE HIGHLY VALUABLE ASSETS OF SUCH OTHER PARTY. 
ARQULE AND DS EACH AGREES THAT, SUBJECT TO SECTION 6.1.2, IT WILL NOT DISCLOSE,
AND WILL CAUSE ITS AFFILIATES AND SUBLICENSEES (OR SUBLICENSEES, AS THE CASE MAY
BE) NOT TO DISCLOSE, ANY CONFIDENTIAL INFORMATION OR PROPRIETARY MATERIALS OF
THE OTHER PARTY AND IT WILL NOT USE, AND WILL CAUSE ITS AFFILIATES AND
SUBLICENSEES (OR SUBLICENSEES, AS THE CASE MAY BE) NOT TO USE, ANY CONFIDENTIAL
INFORMATION OR PROPRIETARY MATERIALS OF THE OTHER PARTY EXCEPT AS EXPRESSLY
PERMITTED HEREUNDER.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS
AGREEMENT, THE OBLIGATIONS OF EACH PARTY UNDER THIS SECTION 6.1.1 SHALL REMAIN
IN EFFECT DURING THE TERM AND FOR AN ADDITIONAL TEN (10) YEARS FOLLOWING THE
TERMINATION OR EXPIRATION OF THIS AGREEMENT.

 

6.1.2                                 LIMITED DISCLOSURE.  ARQULE AND DS EACH
AGREES THAT DISCLOSURE OF ITS CONFIDENTIAL INFORMATION OR ANY TRANSFER OF ITS
PROPRIETARY MATERIALS MAY BE MADE BY THE OTHER PARTY TO ANY EMPLOYEE, CONSULTANT
OR AFFILIATE OF SUCH OTHER PARTY TO ENABLE SUCH OTHER PARTY TO EXERCISE ITS
RIGHTS OR TO CARRY OUT ITS RESPONSIBILITIES UNDER THIS AGREEMENT; PROVIDED,
THAT, ANY SUCH DISCLOSURE OR TRANSFER SHALL ONLY BE MADE TO PERSONS WHO ARE
BOUND BY THE WRITTEN OBLIGATIONS DESCRIBED IN SECTION 6.1.3.  IN ADDITION,
ARQULE AND DS EACH AGREES THAT THE OTHER PARTY MAY DISCLOSE ITS CONFIDENTIAL
INFORMATION (A) ON A NEED-TO-KNOW BASIS TO SUCH OTHER PARTY’S LEGAL AND
FINANCIAL ADVISORS, (B) TO ANY THIRD PARTY AS REASONABLY NECESSARY IN CONNECTION
WITH AN ACTUAL OR POTENTIAL PERMITTED SUBLICENSE OF SUCH OTHER PARTY’S RIGHTS
HEREUNDER OR IN CONNECTION WITH AN ACTUAL OR POTENTIAL COLLABORATION BETWEEN
SUCH PARTY AND A THIRD PARTY OR ANY DEBT OR EQUITY FINANCING OF SUCH OTHER
PARTY, SUBJECT IN EACH CASE, TO THE EXECUTION OF WRITTEN OBLIGATIONS OF
CONFIDENTIALITY SUBSTANTIALLY SIMILAR TO THOSE OF SUCH PARTY HEREUNDER, AND
PROVIDED THAT ANY CONFIDENTIAL INFORMATION SO PROVIDED BY ARQULE IN CONNECTION
WITH A COLLABORATION WILL IN NO EVENT INCLUDE INFORMATION IDENTIFYING ANY DS
TARGETS UNLESS SUCH DISCLOSURE IS SUBJECT TO A

 

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MECHANISM SIMILAR TO THE GATEKEEPER MECHANISM CONTAINED IN SECTION 3.5.2, (C) IF
SUCH OTHER PARTY IS ARQULE, TO ANY THIRD PARTY THAT IS OR MAY BE ENGAGED BY
ARQULE TO PERFORM SERVICES IN CONNECTION WITH THE RESEARCH PROGRAM, AND (D) FOR
ANY OTHER PURPOSE WITH THE OTHER PARTY’S WRITTEN CONSENT, WHICH CONSENT SHALL
NOT BE UNREASONABLY WITHHELD, CONDITIONED OR DELAYED.  IN ADDITION, EACH PARTY
AGREES THAT THE OTHER PARTY MAY DISCLOSE SUCH PARTY’S CONFIDENTIAL INFORMATION
OR PROPRIETARY MATERIALS (A) AS REASONABLY NECESSARY TO FILE, PROSECUTE OR
MAINTAIN PATENT RIGHTS, OR TO FILE, PROSECUTE OR DEFEND LITIGATION RELATED TO
PATENT RIGHTS, IN ACCORDANCE WITH THIS AGREEMENT; OR (B) AS REQUIRED BY
APPLICABLE LAWS; PROVIDED, THAT, IN THE CASE OF ANY DISCLOSURE UNDER THIS CLAUSE
(B), THE DISCLOSING PARTY SHALL (1) IF PRACTICABLE, PROVIDE THE OTHER PARTY WITH
REASONABLE ADVANCE NOTICE OF AND AN OPPORTUNITY TO COMMENT ON ANY SUCH REQUIRED
DISCLOSURE AND (2) IF REQUESTED BY THE OTHER PARTY, COOPERATE IN ALL REASONABLE
RESPECTS WITH THE OTHER PARTY’S EFFORTS TO OBTAIN CONFIDENTIAL TREATMENT OR A
PROTECTIVE ORDER WITH RESPECT TO ANY SUCH DISCLOSURE, AT THE OTHER PARTY’S
EXPENSE.

 

6.1.3                                 EMPLOYEES AND CONSULTANTS.  ARQULE AND DS
EACH HEREBY REPRESENTS THAT ALL OF ITS EMPLOYEES AND CONSULTANTS, AND ALL OF THE
EMPLOYEES AND CONSULTANTS OF ITS AFFILIATES, WHO PARTICIPATE IN THE ACTIVITIES
OF THE COLLABORATION OR HAVE ACCESS TO CONFIDENTIAL INFORMATION OR PROPRIETARY
MATERIALS OF THE OTHER PARTY ARE OR WILL, PRIOR TO THEIR PARTICIPATION OR
ACCESS, BE BOUND BY WRITTEN OBLIGATIONS TO MAINTAIN SUCH CONFIDENTIAL
INFORMATION OR PROPRIETARY MATERIALS IN CONFIDENCE AND NOT TO USE SUCH
INFORMATION EXCEPT AS EXPRESSLY PERMITTED HEREUNDER.  EACH PARTY AGREES TO USE,
AND TO CAUSE ITS AFFILIATES TO USE, REASONABLE EFFORTS TO ENFORCE SUCH
OBLIGATIONS.

 

6.2                                 PUBLICITY.  THE PARTIES ACKNOWLEDGE THAT THE
TERMS OF THIS AGREEMENT CONSTITUTE CONFIDENTIAL INFORMATION OF EACH PARTY AND
MAY NOT BE DISCLOSED EXCEPT AS PERMITTED BY SECTION 6.1.2 AND THIS SECTION 6.2. 
NOTWITHSTANDING THE FOREGOING, THE TERMS OF THIS AGREEMENT MAY BE DISCLOSED BY A
PARTY TO INVESTMENT BANKERS, ANALYSTS, INVESTORS AND POTENTIAL INVESTORS,
LENDERS AND POTENTIAL LENDERS AND OTHER SOURCES AND OTHER POTENTIAL SOURCES OF
FINANCING, OR ANY ACQUIRER OR MERGER PARTNER AND POTENTIAL ACQUIRER OR MERGER
PARTNER BUT ONLY TO THE EXTENT REASONABLY NECESSARY.  IN ADDITION, A COPY OF
THIS AGREEMENT MAY BE FILED BY EITHER PARTY WITH THE U.S. SECURITIES AND
EXCHANGE COMMISSION, OR COMPARABLE ADMINISTRATIVE/REGULATORY BODY IN OTHER
JURISDICTIONS, IF SUCH FILING IS REQUIRED BY LAW OR REGULATION.  IN CONNECTION
WITH ANY SUCH FILING,

 

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SUCH PARTY SHALL ENDEAVOR TO OBTAIN CONFIDENTIAL TREATMENT OF ECONOMIC AND TRADE
SECRET INFORMATION, AND SHALL PROVIDE THE OTHER PARTY WITH THE PROPOSED
CONFIDENTIAL TREATMENT REQUEST WITH REASONABLE TIME FOR SUCH OTHER PARTY TO
PROVIDE COMMENTS, WHICH COMMENTS SHALL BE REASONABLY CONSIDERED BY THE FILING
PARTY.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN SECTION 6.1, THE PARTIES,
UPON THE EXECUTION OF THIS AGREEMENT, SHALL AGREE TO A PRESS RELEASE WITH
RESPECT TO THIS AGREEMENT, AND EITHER PARTY MAY MAKE SUBSEQUENT PUBLIC
DISCLOSURE OF THE CONTENTS OF SUCH PRESS RELEASE WITHOUT FURTHER APPROVAL OF THE
OTHER PARTY.  AFTER ISSUANCE OF SUCH PRESS RELEASE, EXCEPT AS REQUIRED BY
APPLICABLE LAWS, NEITHER PARTY SHALL ISSUE A PRESS OR NEWS RELEASE OR MAKE ANY
SIMILAR PUBLIC ANNOUNCEMENT (IT BEING UNDERSTOOD THAT PUBLICATION IN SCIENTIFIC
JOURNALS, PRESENTATION AT SCIENTIFIC CONFERENCES AND MEETINGS AND THE LIKE ARE
INTENDED TO BE COVERED BY SECTION 6.3 AND NOT SUBJECT TO THIS SECTION 6.2)
RELATED TO THE RESEARCH PROGRAM OR TO ANY DEVELOPMENT PROGRAM WITHOUT THE PRIOR
WRITTEN CONSENT OF THE OTHER PARTY; PROVIDED, THAT, NOTWITHSTANDING THE
FOREGOING, ARQULE SHALL BE EXPRESSLY PERMITTED TO PUBLICLY ANNOUNCE THE
OCCURRENCE OF ANY MILESTONE EVENT AND ANY OTHER EVENT THAT ARQULE REASONABLY
BELIEVES IS MATERIAL TO ARQULE.

 

6.3                                 PUBLICATIONS AND PRESENTATIONS.  THE PARTIES
ACKNOWLEDGE THAT SCIENTIFIC PUBLICATIONS AND PRESENTATIONS MUST BE STRICTLY
MONITORED TO PREVENT ANY ADVERSE EFFECT FROM PREMATURE PUBLICATION OR
DISSEMINATION OF RESULTS OF THE ACTIVITIES HEREUNDER.  EACH PARTY AGREES THAT,
EXCEPT AS REQUIRED BY APPLICABLE LAWS, IT SHALL NOT PUBLISH OR PRESENT, OR
PERMIT TO BE PUBLISHED OR PRESENTED, THE RESULTS OF THE RESEARCH PROGRAM OR THE
DEVELOPMENT PROGRAM WITHOUT THE PRIOR REVIEW BY AND WRITTEN APPROVAL OF THE
OTHER PARTY.  EACH PARTY SHALL PROVIDE TO THE OTHER PARTY THE OPPORTUNITY TO
REVIEW EACH OF THE SUBMITTING PARTY’S PROPOSED ABSTRACTS, MANUSCRIPTS OR
PRESENTATIONS (INCLUDING, WITHOUT LIMITATION, INFORMATION TO BE PRESENTED
VERBALLY) THAT RELATE TO THE RESEARCH PROGRAM OR THE DEVELOPMENT PROGRAM AT
LEAST * (*) DAYS PRIOR TO ITS INTENDED PRESENTATION OR SUBMISSION FOR
PUBLICATION, AND SUCH SUBMITTING PARTY AGREES, UPON WRITTEN REQUEST FROM THE
OTHER PARTY GIVEN WITHIN SUCH * (*) DAY PERIOD, NOT TO SUBMIT SUCH ABSTRACT OR
MANUSCRIPT FOR PUBLICATION OR TO MAKE SUCH PRESENTATION UNTIL THE OTHER PARTY IS
GIVEN UP TO * (*) DAYS FROM THE DATE OF SUCH WRITTEN REQUEST TO SEEK APPROPRIATE
PATENT PROTECTION FOR ANY MATERIAL IN SUCH PUBLICATION OR PRESENTATION THAT IT
REASONABLY BELIEVES MAY BE PATENTABLE.  ONCE SUCH ABSTRACTS, MANUSCRIPTS OR
PRESENTATIONS HAVE BEEN REVIEWED AND APPROVED BY EACH PARTY, THE

 

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SAME ABSTRACTS, MANUSCRIPTS OR PRESENTATIONS DO NOT HAVE TO BE PROVIDED AGAIN TO
THE OTHER PARTY FOR REVIEW FOR A LATER SUBMISSION FOR PUBLICATION.  EACH PARTY
ALSO SHALL HAVE THE RIGHT TO REQUIRE THAT ANY OF ITS CONFIDENTIAL INFORMATION
THAT IS DISCLOSED IN ANY SUCH PROPOSED PUBLICATION OR PRESENTATION BE DELETED
PRIOR TO SUCH PUBLICATION OR PRESENTATION.  IN ANY PERMITTED PUBLICATION OR
PRESENTATION BY A PARTY, THE OTHER PARTY’S CONTRIBUTION SHALL BE DULY
RECOGNIZED, AND CO-AUTHORSHIP SHALL BE DETERMINED IN ACCORDANCE WITH CUSTOMARY
STANDARDS.  EACH PARTY (A) EXPRESSLY ACKNOWLEDGES THAT THE OTHER PARTY’S
BUSINESS MAY BE SUBSTANTIALLY DEPENDENT ON ITS ABILITY TO PUBLISH RESULTS IN
SCIENTIFIC JOURNALS, PRESENTATION AT SCIENTIFIC CONFERENCES AND MEETINGS AND
(B) AGREES THAT IT SHALL NOT UNREASONABLY WITHHOLD, CONDITION OR DELAY ITS
CONSENT TO ANY REQUEST BY THE OTHER PARTY TO PUBLISH RESULTS OF THE RESEARCH
PROGRAM OR ANY DEVELOPMENT PROGRAM IN ACCORDANCE WITH ITS INTERNAL PUBLICATION
GUIDELINES.

 

6.4                                 AKIP PLATFORM TECHNOLOGY.  NOTWITHSTANDING
ANYTHING TO THE CONTRARY SET FORTH HEREIN, INCLUDING WITHOUT LIMITATION, THE
RIGHT TO DISCLOSE CONFIDENTIAL INFORMATION OF ARQULE SET FORTH IN SECTION 6.2
AND THE RIGHTS TO PUBLISH SET FORTH IN SECTION 6.3, DS SHALL IN NO EVENT
DISCLOSE ANY CONFIDENTIAL INFORMATION OF ARQULE RELATING TO AKIP PLATFORM
TECHNOLOGY.

 

6.5                                 PROHIBITION ON SOLICITATION.  WITHOUT THE
WRITTEN CONSENT OF THE OTHER PARTY, NEITHER PARTY NOR ITS AFFILIATES SHALL,
DURING THE RESEARCH COLLABORATION PERIOD OR FOR ONE (1) YEAR THEREAFTER, SOLICIT
(DIRECTLY OR INDIRECTLY) ANY EMPLOYEE OF THE OTHER PARTY OR ITS AFFILIATES WHO
PARTICIPATED IN THE RESEARCH PROGRAM AT ANY TIME DURING THE RESEARCH
COLLABORATION PERIOD.  THIS PROVISION SHALL NOT RESTRICT EITHER PARTY OR ITS
AFFILIATES FROM ADVERTISING EMPLOYMENT OPPORTUNITIES IN ANY MANNER THAT DOES NOT
DIRECTLY TARGET THE OTHER PARTY OR ITS AFFILIATES.

 

7.                                      LICENSE GRANTS; EXCLUSIVITY

 

7.1                                 DS OPTION.

 

7.1.1                                 OPTION GRANT.  ARQULE HEREBY GRANTS DS AN
OPTION (EACH, A “DS OPTION”) TO OBTAIN AN EXCLUSIVE, ROYALTY-BEARING LICENSE
UNDER THE LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS FOR THE PURPOSE OF
DEVELOPING AND COMMERCIALIZING PRIMARY DEVELOPMENT COMPOUNDS AND RELATED BACKUP
COMPOUNDS IN THE FIELD AND IN THE TERRITORY.  FOR PURPOSES OF CLARITY, (A) DS
OPTIONS SHALL BE AVAILABLE TO DS ON A DS TARGET BY DS TARGET BASIS AND (B) A DS
OPTION SHALL ONLY BE AVAILABLE WITH RESPECT TO COLLABORATION COMPOUNDS THAT ARE

 

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DESIGNATED AS PRIMARY DEVELOPMENT COMPOUNDS AND BACKUP COMPOUNDS FOR PURPOSES OF
THIS AGREEMENT.

 

7.1.2                                 OPTION EXERCISE.

 

(A)                                  PRIMARY DEVELOPMENT COMPOUNDS.  DS MAY
EXERCISE ANY DS OPTION AT ANY TIME DURING THE APPLICABLE DS OPTION PERIOD BY
GIVING WRITTEN NOTICE OF EXERCISE TO ARQULE, WHICH NOTICE SHALL DESIGNATE THE
PRIMARY DEVELOPMENT COMPOUND (AND RELATED BACKUP COMPOUNDS) (THE “DS OPTION
EXERCISE NOTICE”); PROVIDED, THAT, (I) DS HEREBY AGREES IF IT DETERMINES NOT TO
EXERCISE A DS OPTION PRIOR TO EXPIRATION OF THE APPLICABLE DS OPTION PERIOD, IT
SHALL IN GOOD FAITH PROVIDE WRITTEN NOTICE TO ARQULE PROMPTLY UPON SUCH
DETERMINATION AND (II) THE DATE ON WHICH ANY SUCH NOTICE IS GIVEN SHALL
CONSTITUTE THE LAST DAY OF THE APPLICABLE DS OPTION PERIOD FOR ALL COLLABORATION
COMPOUNDS AGAINST THE DS TARGET AGAINST WHICH SUCH PRIMARY DEVELOPMENT COMPOUND
IS DIRECTED.  UPON THE EXERCISE BY DS OF EACH DS OPTION, (A) THE PRIMARY
DEVELOPMENT COMPOUND THAT IS THE SUBJECT OF THE DS OPTION (AND RELATED BACKUP
COMPOUNDS) SHALL BE DEEMED TO BE LICENSED PRODUCTS FOR PURPOSES OF THIS
AGREEMENT AND (B) DS AND ARQULE SHALL NEGOTIATE A LICENSE AGREEMENT (A “LICENSE
AGREEMENT”) WHICH SHALL CONTAIN THE EXCLUSIVE LICENSES WITH RESPECT TO SUCH
LICENSED PRODUCTS SET FORTH IN SECTIONS 7.3.1 AND 7.4 AND THE SUBSTANTIALLY
SIMILAR PROVISIONS AS SET FORTH IN SECTIONS 7.5, 7.6, 7.7, ARTICLE 8, ARTICLE 9,
ARTICLE 10, ARTICLE 12 AND ARTICLE 13 HEREIN; PROVIDED, THAT, SUCH PROVISIONS
WILL BE LIMITED TO THE PRIMARY DEVELOPMENT COMPOUND (AND RELATED BACKUP
COMPOUNDS) AND LICENSED PRODUCTS WHICH ARE THE SUBJECT OF THE LICENSE AGREEMENT.

 

(B)                                 BACKUP COMPOUNDS.  AT ANY TIME BEFORE THE
EXPIRATION OF THE DS OPTION PERIOD FOR THE DS TARGET OF ANY PRIMARY DEVELOPMENT
COMPOUND, DS MAY DESIGNATE UP TO * (*) BACKUP COMPOUNDS TO SUCH PRIMARY
DEVELOPMENT COMPOUND BY GIVING WRITTEN NOTICE OF DESIGNATION TO ARQULE, WHICH
NOTICE SHALL IDENTIFY SUCH BACKUP COMPOUNDS (THE “DS BACKUP COMPOUND NOTICE”). 
NO BACKUP COMPOUND MAY BE DESIGNATED AFTER THE EXPIRATION OF THE DS OPTION
PERIOD FOR THE DS TARGET OF THE RELEVANT PRIMARY DEVELOPMENT COMPOUND.

 

7.1.3                                 EXPIRATION OF DS OPTION.  IF DS FAILS TO
EXERCISE THE DS OPTION APPLICABLE TO A PRIMARY DEVELOPMENT COMPOUND (AND RELATED
BACKUP COMPOUNDS) ON OR BEFORE THE EXPIRATION OF THE APPLICABLE DS OPTION
PERIOD, THEN SUCH PRIMARY DEVELOPMENT COMPOUND

 

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(AND RELATED BACKUP COMPOUNDS) SHALL BE DEEMED TO BE A WAIVED COMPOUND FOR
PURPOSES OF THIS AGREEMENT.

 

7.2                                 RESEARCH LICENSES.

 

7.2.1                                 ARQULE GRANT.  SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, ARQULE HEREBY GRANTS TO DS AND ITS AFFILIATES A
NON-EXCLUSIVE, ROYALTY-FREE, WORLDWIDE LICENSE UNTIL THE EXPIRATION OF THE LAST
TO EXPIRE DS OPTION PERIOD UNDER LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS,
FOR THE SOLE PURPOSE OF CONDUCTING DS RESEARCH ACTIVITIES IN THE RESEARCH
PROGRAM.

 

7.2.2                                 DS GRANTS.  SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, DS HEREBY GRANTS TO ARQULE AND ITS AFFILIATES A
NON-EXCLUSIVE, ROYALTY-FREE, WORLDWIDE LICENSE UNTIL THE EXPIRATION OF THE LAST
TO EXPIRE DS OPTION PERIOD UNDER DS TECHNOLOGY AND DS PATENT RIGHTS THAT IS
NECESSARY OR USEFUL FOR ARQULE TO CARRY OUT ITS OBLIGATIONS UNDER THE ANNUAL
RESEARCH PLAN, AND FOR THE SOLE PURPOSE OF CONDUCTING ARQULE RESEARCH ACTIVITIES
IN THE RESEARCH PROGRAM.

 

7.3                                 DEVELOPMENT LICENSES.

 

7.3.1                                 ARQULE GRANT.  IN THE EVENT OF EXERCISE BY
DS OF THE DS OPTION FOR A PRIMARY DEVELOPMENT COMPOUND AND RELATED BACKUP
COMPOUNDS, SUBJECT TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, IN THE LICENSE
AGREEMENT NEGOTIATED UPON THE EXERCISE OF THE DS OPTION FOR SUCH PRIMARY
DEVELOPMENT COMPOUND (AND RELATED BACKUP COMPOUNDS), ARQULE WILL GRANT TO DS AND
ITS AFFILIATES, AN EXCLUSIVE, ROYALTY BEARING, WORLDWIDE LICENSE DURING THE
TERM, INCLUDING THE RIGHT TO GRANT SUBLICENSES TO SUBLICENSEES AS PROVIDED IN
SECTIONS 7.5, UNDER LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS, FOR THE SOLE
PURPOSE OF DEVELOPING SUCH PRIMARY DEVELOPMENT COMPOUND AND RELATED BACKUP
COMPOUNDS AND LICENSED PRODUCTS WITH RESPECT THERETO IN THE FIELD AND IN THE
TERRITORY.  NOTWITHSTANDING THE FOREGOING, DURING THE PERIOD COMMENCING ON THE
DATE OF EXPIRATION OR TERMINATION OF THE RESEARCH COLLABORATION PERIOD AND
CONTINUING FOR THE REMAINDER OF THE TERM, ARQULE HEREBY RETAINS THE RIGHT TO
DEVELOP AND COMMERCIALIZE ALL WAIVED COMPOUNDS AND TERMINATED COMPOUNDS.

 

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7.3.2                                 DS GRANT.  EFFECTIVE UPON EXERCISE BY DS
OF THE DS OPTION FOR A PRIMARY DEVELOPMENT COMPOUND AND RELATED BACKUP
COMPOUNDS, SUBJECT TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, DS HEREBY
GRANTS TO ARQULE AND ITS AFFILIATES A NON-EXCLUSIVE, ROYALTY-FREE, WORLDWIDE
LICENSE DURING THE TERM, WITHOUT THE RIGHT TO GRANT SUBLICENSES, UNDER DS
TECHNOLOGY AND DS PATENT RIGHTS THAT IS NECESSARY OR USEFUL FOR ARQULE TO CARRY
OUT ANY DEVELOPMENT ACTIVITIES WHICH THE PARTIES AGREE THAT ARQULE SHALL
PERFORM, AND DS’S INTEREST IN JOINT TECHNOLOGY AND JOINT PATENT RIGHTS AND UNDER
LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS EXCLUSIVELY LICENSED TO DS UNDER
SECTION 7.3.1, FOR THE SOLE PURPOSE OF CONDUCTING THE SUCH DEVELOPMENT
ACTIVITIES IN ANY DEVELOPMENT PROGRAM.

 

7.3.3                                 WAIVED COMPOUND; TERMINATED COMPOUNDS. 
SUBJECT TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, DS HEREBY GRANTS TO
ARQULE AND ITS AFFILIATES AN EXCLUSIVE, WORLDWIDE, ROYALTY-FREE LICENSE, WITH
THE RIGHT TO GRANT SUBLICENSES, UNDER DS PROGRAM TECHNOLOGY, PATENT RIGHTS
CLAIMING DS PROGRAM TECHNOLOGY AND DS’S INTEREST IN JOINT TECHNOLOGY AND JOINT
PATENT RIGHTS TO RESEARCH, DEVELOP, HAVE DEVELOPED, MAKE, HAVE MADE, USE,
DISTRIBUTE FOR SALE, SELL, OFFER FOR SALE, IMPORT AND HAVE IMPORTED WAIVED
COMPOUNDS AND TERMINATED COMPOUNDS FOR ANY AND ALL USES, BOTH WITHIN AND OUTSIDE
OF THE FIELD.  SUBJECT TO SECTION 9.1.5, DS SHALL RETAIN ALL RIGHTS TO SUCH DS
PROGRAM TECHNOLOGY, PATENT RIGHTS CLAIMING DS PROGRAM TECHNOLOGY AND DS’S
INTEREST IN JOINT TECHNOLOGY AND JOINT PATENT RIGHTS FOR ALL OTHER PURPOSES.

 

7.4                                 COMMERCIALIZATION LICENSE.  IN THE EVENT OF
EXERCISE BY DS OF THE DS OPTION FOR A PRIMARY DEVELOPMENT COMPOUND AND RELATED
BACKUP COMPOUNDS, SUBJECT TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, THE
LICENSE AGREEMENT NEGOTIATED UPON THE EXERCISE OF THE DS OPTION WITH RESPECT TO
SUCH PRIMARY DEVELOPMENT COMPOUND (AND RELATED BACKUP COMPOUNDS), WILL GRANT TO
DS AND ITS AFFILIATES AN EXCLUSIVE, ROYALTY-BEARING LICENSE DURING THE TERM,
INCLUDING THE RIGHT TO GRANT SUBLICENSES TO SUBLICENSEES AS PROVIDED IN
SECTION 7.5, UNDER LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS FOR THE SOLE
PURPOSE OF COMMERCIALIZING LICENSED PRODUCTS WITH RESPECT TO SUCH PRIMARY
DEVELOPMENT COMPOUND AND RELATED BACKUP COMPOUNDS IN THE FIELD IN THE TERRITORY.

 

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7.5                                 RIGHT TO SUBLICENSE.  DS SHALL HAVE THE
RIGHT TO GRANT SUBLICENSES TO SUBLICENSEES UNDER THE LICENSES GRANTED TO IT
UNDER THE LICENSE AGREEMENT WITH RESPECT TO ANY PRIMARY DEVELOPMENT COMPOUNDS
(AND RELATED BACKUP COMPOUNDS) AND LICENSED PRODUCTS; PROVIDED, THAT, (A) IT
SHALL BE A CONDITION OF ANY SUCH SUBLICENSE THAT SUCH SUBLICENSEE AGREES TO BE
BOUND BY ALL TERMS OF THIS AGREEMENT AND THE LICENSE AGREEMENT APPLICABLE TO THE
DEVELOPMENT OR COMMERCIALIZATION, AS THE CASE MAY BE, OF LICENSED PRODUCTS IN
THE FIELD IN THE TERRITORY (INCLUDING, WITHOUT LIMITATION, ARTICLE 6); (B) DS
SHALL PROVIDE WRITTEN NOTICE TO ARQULE OF ANY SUCH PROPOSED SUBLICENSE AT LEAST
THIRTY (30) DAYS PRIOR TO SUCH EXECUTION AND PROVIDE COPIES TO ARQULE OF EACH
SUCH SUBLICENSE IN THE FORM TO BE EXECUTED AT LEAST TEN (10) BUSINESS DAYS PRIOR
TO SUCH EXECUTION; (C) IF DS GRANTS A SUBLICENSE TO A SUBLICENSEE, DS SHALL BE
DEEMED TO HAVE GUARANTEED THAT SUCH SUBLICENSEE WILL FULFILL ALL OF DS’S
OBLIGATIONS UNDER THIS AGREEMENT APPLICABLE TO THE SUBJECT MATTER OF SUCH
SUBLICENSE; AND (D) DS SHALL NOT BE RELIEVED OF ITS OBLIGATIONS PURSUANT TO THIS
AGREEMENT OR THE LICENSE AGREEMENT AS A RESULT OF SUCH SUBLICENSE.  ANY
SUBLICENSES GRANTED BY DS TO SUBLICENSEE UNDER SECTION 7.3.1 AND/OR SECTION 7.4
WITH RESPECT TO LICENSED PRODUCTS AND CO-COMMERCIALIZED LICENSED PRODUCTS SHALL
REQUIRE ARQULE’S CONSENT, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD,
DELAYED OR CONDITIONED.  SUBLICENSES TO AFFILIATES OF DS SHALL NOT REQUIRE
ARQULE’S CONSENT.

 

7.6                                 NO OTHER RIGHTS.  DS SHALL HAVE NO RIGHTS TO
USE OR OTHERWISE EXPLOIT ARQULE TECHNOLOGY, ARQULE PATENT RIGHTS, OR ARQULE
PROPRIETARY MATERIALS, AND ARQULE SHALL HAVE NO RIGHTS TO USE OR OTHERWISE
EXPLOIT DS TECHNOLOGY, DS PATENT RIGHTS OR DS PROPRIETARY MATERIALS, IN EACH
CASE, EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 7 OR A LICENSE AGREEMENT. 
NO RIGHT IS GRANTED TO DS TO PRACTICE OR USE AKIP PLATFORM TECHNOLOGY FOR ANY
PURPOSE.

 

7.7                                 EXCLUSIVITY.

 

7.7.1                                 ARQULE.  ARQULE SHALL NOT, AND SHALL CAUSE
EACH OF ITS AFFILIATES TO NOT, CONDUCT OR FUND ANY RESEARCH, DEVELOPMENT OR
COMMERCIALIZATION ACTIVITY, EITHER ON ITS OWN, OR WITH, FOR THE BENEFIT OF, OR
SPONSORED BY, ANY THIRD PARTY, THAT INVOLVES THE RESEARCH, DEVELOPMENT OR
COMMERCIALIZATION OF, OR GRANT ANY LICENSE OR OTHER RIGHTS TO ANY THIRD PARTY TO
UTILIZE ANY TECHNOLOGY OR PATENT RIGHTS CONTROLLED BY ARQULE OR ANY OF ITS
AFFILIATES FOR THE EXPRESS PURPOSE OF RESEARCHING, DEVELOPING OR COMMERCIALIZING
(A) ANY COMPOUND THAT MEETS

 

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CLAUSES (I), (II) AND (III) OF THE MINIMUM REQUIREMENTS FOR A DS TARGET FOR
WHICH DS HAS EXERCISED THE DS OPTION OR FOR WHICH THE DS OPTION PERIOD HAS NOT
EXPIRED, OR (B) ANY LICENSED PRODUCT THAT DS IS ACTIVELY DEVELOPING OR
COMMERCIALIZING FOR ANY USE, WHETHER WITHIN OR OUTSIDE OF THE FIELD, EXCEPT
HEREUNDER IN THE RESEARCH PROGRAM, OR THE DEVELOPMENT OR THE COMMERCIALIZATION
OF LICENSED PRODUCTS UNDER A LICENSE AGREEMENT.  NOTWITHSTANDING THE FOREGOING,
DURING THE PERIOD COMMENCING ON THE DATE OF TERMINATION OR EXPIRATION OF THE
RESEARCH COLLABORATION PERIOD AND CONTINUING FOR THE REMAINDER OF THE TERM,
ARQULE SHALL HAVE THE RIGHT TO RESEARCH, DEVELOP AND/OR COMMERCIALIZE, AND GRANT
LICENSES OR OTHER RIGHTS TO ANY THIRD PARTY TO UTILIZE ANY PROPRIETARY
MATERIALS, TECHNOLOGY OR PATENT RIGHTS CONTROLLED IN WHOLE OR IN PART BY ARQULE
OR ANY OF ITS AFFILIATES FOR THE PURPOSE OF RESEARCHING, DEVELOPING OR
COMMERCIALIZING, ANY AND ALL WAIVED COMPOUNDS AND TERMINATED COMPOUNDS.

 

7.7.2                                 DS.  DS SHALL NOT, AND SHALL CAUSE EACH OF
ITS AFFILIATES TO NOT, CONDUCT ANY RESEARCH, DEVELOPMENT OR COMMERCIALIZATION
ACTIVITY, EITHER ON ITS OWN, OR WITH, FOR THE BENEFIT OF, OR SPONSORED BY, ANY
THIRD PARTY, THAT INVOLVES THE RESEARCH, DEVELOPMENT OR COMMERCIALIZATION, OR
GRANT ANY LICENSE OR OTHER RIGHTS TO ANY THIRD PARTY TO UTILIZE ANY TECHNOLOGY
OR PATENT RIGHTS CONTROLLED BY DS OR ANY OF ITS AFFILIATES FOR THE EXPRESS
PURPOSE OF RESEARCHING, DEVELOPING OR COMMERCIALIZING (A) ANY COMPOUND THAT
MEETS CLAUSES (I) AND (II) OF THE MINIMUM REQUIREMENTS FOR A DS TARGET FOR WHICH
DS HAS EXERCISED THE DS OPTION OR FOR WHICH THE DS OPTION PERIOD HAS NOT EXPIRED
OR (B) ANY COLLABORATION COMPOUND OR LICENSED PRODUCT FOR ANY USE, WHETHER
WITHIN OR OUTSIDE OF THE FIELD, EXCEPT HEREUNDER IN THE RESEARCH PROGRAM, THE
DEVELOPMENT OF COLLABORATION COMPOUND, THE COMMERCIALIZATION OF LICENSED
PRODUCTS UNDER A LICENSE AGREEMENT AND/OR AS PROVIDED IN SECTION 4.11.

 

8.                        INTELLECTUAL PROPERTY RIGHTS

 

8.1                                 ARQULE INTELLECTUAL PROPERTY RIGHTS.  ARQULE
SHALL HAVE SOLE AND EXCLUSIVE OWNERSHIP OF ALL RIGHT, TITLE AND INTEREST ON A
WORLDWIDE BASIS IN AND TO ANY AND ALL ARQULE TECHNOLOGY AND ARQULE PATENT
RIGHTS.

 

8.2                                 DS INTELLECTUAL PROPERTY RIGHTS.  DS SHALL
HAVE SOLE AND EXCLUSIVE OWNERSHIP OF ALL RIGHT, TITLE AND INTEREST ON A
WORLDWIDE BASIS IN AND TO ANY AND ALL DS TECHNOLOGY, LICENSED PRODUCT TRADEMARKS
AND DS PATENT RIGHTS.

 

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8.3                                 JOINT TECHNOLOGY AND JOINT PATENT RIGHTS. 
DS AND ARQULE SHALL JOINTLY OWN ALL JOINT TECHNOLOGY AND JOINT PATENT RIGHTS.
 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT OR UNDER
APPLICABLE LAW, EXCEPT TO THE EXTENT EXCLUSIVELY LICENSED TO ONE PARTY UNDER
THIS AGREEMENT, THE PARTIES HEREBY AGREE THAT EITHER PARTY MAY USE OR LICENSE OR
SUBLICENSE TO AFFILIATES OR THIRD PARTIES ALL OR ANY PORTION OF ITS INTEREST IN
JOINT TECHNOLOGY AND/OR JOINT PATENT RIGHTS OR JOINTLY OWNED CONFIDENTIAL
INFORMATION OR PROPRIETARY MATERIALS FOR USE OUTSIDE THE FIELD WITHOUT THE PRIOR
WRITTEN CONSENT OF THE OTHER PARTY, WITHOUT RESTRICTION AND WITHOUT THE
OBLIGATION TO PROVIDE COMPENSATION TO THE OTHER PARTY; PROVIDED, THAT, DURING
THE TERM OF THIS AGREEMENT, NEITHER PARTY MAY USE OR LICENSE OR SUBLICENSE TO
THIRD PARTIES ALL OR ANY PORTION OF ITS INTEREST IN JOINT TECHNOLOGY AND/OR
JOINT PATENT RIGHTS OR JOINTLY OWNED CONFIDENTIAL INFORMATION OR PROPRIETARY
MATERIALS FOR USE IN THE FIELD AGAINST DS TARGETS FOR WHICH DS HAS EXERCISED THE
DS OPTION OR FOR WHICH THE DS OPTION PERIOD HAS NOT EXPIRED.

 

8.4                                 PATENT COORDINATORS.  ARQULE AND DS SHALL
EACH APPOINT A PATENT COORDINATOR REASONABLY ACCEPTABLE TO THE OTHER PARTY
(EACH, A “PATENT COORDINATOR”) TO SERVE AS SUCH PARTY’S PRIMARY LIAISON WITH THE
OTHER PARTY ON MATTERS RELATING TO PATENT FILING, PROSECUTION, MAINTENANCE AND
ENFORCEMENT.  EACH PARTY MAY REPLACE ITS PATENT COORDINATOR AT ANY TIME BY
NOTICE IN WRITING TO THE OTHER PARTY.  THE INITIAL PATENT COORDINATORS SHALL BE:

 

For ARQULE:                      Mark Ashwell, Ph. D.

 

For DS: Dr. Kazuo Sato, General Manager, Intellectual Property, DAIICHI SANKYO,
CO., LTD.

 

8.5                                 INVENTORSHIP.  IN CASE OF A DISPUTE BETWEEN
ARQULE AND DS OVER INVENTORSHIP AND, AS A RESULT, WHETHER ANY PARTICULAR PROGRAM
TECHNOLOGY IS ARQULE TECHNOLOGY, DS TECHNOLOGY OR JOINT TECHNOLOGY, IT SHALL BE
DETERMINED BY APPLICABLE UNITED STATES PATENT LAW.

 

8.6                                 COOPERATION.  EACH PARTY SHALL COOPERATE
WITH THE OTHER PARTY TO EFFECT THE INTENT OF THIS ARTICLE 8, INCLUDING WITHOUT
LIMITATION BY EXECUTING DOCUMENTS AND MAKING ITS EMPLOYEES AND INDEPENDENT
CONTRACTORS AVAILABLE TO EXECUTE DOCUMENTS AS NECESSARY TO ACHIEVE THE FOREGOING
ALLOCATION OF OWNERSHIP RIGHTS.

 

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9.                                      FILING, PROSECUTION AND MAINTENANCE OF
PATENT RIGHTS

 

9.1                                 PATENT FILING, PROSECUTION AND MAINTENANCE.

 

9.1.1                                 DS’S PROSECUTION RIGHTS.

 

(A)                                  DS PROGRAM TECHNOLOGY.  SUBJECT TO SECTIONS
9.1.4 AND 9.1.5, DS, ACTING THROUGH PATENT COUNSEL OR AGENTS OF ITS CHOICE,
SHALL BE RESPONSIBLE FOR THE PREPARATION, FILING, PROSECUTION AND MAINTENANCE,
AT ITS SOLE COST AND EXPENSE, OF PATENT RIGHTS COVERING DS PROGRAM TECHNOLOGY. 
AT DS’S REQUEST, ARQULE SHALL COOPERATE WITH DS IN ALL REASONABLE RESPECTS IN
CONNECTION WITH SUCH PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF SUCH
PATENT RIGHTS, INCLUDING BUT NOT LIMITED TO OBTAINING ASSIGNMENTS TO REFLECT
CHAIN OF TITLE CONSISTENT WITH THE TERMS OF THIS AGREEMENT, GAINING UNITED
STATES PATENT TERM EXTENSIONS, SUPPLEMENTARY PROTECTION CERTIFICATES AND ANY
OTHER EXTENSIONS THAT ARE NOW OR BECOME AVAILABLE IN THE FUTURE WHEREVER
APPLICABLE.  FOR PURPOSES OF CLARITY, NOTWITHSTANDING ANYTHING TO THE CONTRARY
HEREIN, DS SHALL HAVE NO RIGHTS TO PREPARE, FILE, PROSECUTE AND/OR MAINTAIN ANY
PATENT RIGHTS RELATED TO THE AKIP PLATFORM TECHNOLOGY.

 

(B)                                 DS BACKGROUND TECHNOLOGY.  DS, AT ITS SOLE
EXPENSE AND ACTING THROUGH PATENT COUNSEL OR AGENTS OF ITS CHOICE, SHALL BE
RESPONSIBLE FOR THE PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF ALL
PATENT RIGHTS COVERING DS BACKGROUND TECHNOLOGY.

 

9.1.2                                 ARQULE PROSECUTION RIGHTS.

 

(A)                                  ARQULE PROGRAM TECHNOLOGY.  SUBJECT TO
SECTIONS 9.1.4 AND 9.1.5, ARQULE, ACTING THROUGH PATENT COUNSEL OR AGENTS OF ITS
CHOICE, SHALL BE RESPONSIBLE FOR THE PREPARATION, FILING, PROSECUTION AND
MAINTENANCE, AT ITS SOLE COST AND EXPENSE, OF PATENT RIGHTS COVERING ARQULE
PROGRAM TECHNOLOGY.  AT ARQULE’S REQUEST, DS SHALL COOPERATE WITH AND ASSIST
ARQULE IN ALL REASONABLE RESPECTS IN CONNECTION WITH SUCH PREPARATION, FILING,
PROSECUTION AND MAINTENANCE OF SUCH PATENT RIGHTS, INCLUDING BUT NOT LIMITED TO
OBTAINING ASSIGNMENTS TO REFLECT CHAIN OF TITLE CONSISTENT WITH THE TERMS OF
THIS AGREEMENT, GAINING UNITED STATES PATENT TERM EXTENSIONS, SUPPLEMENTARY
PROTECTION CERTIFICATES AND ANY OTHER EXTENSIONS THAT ARE NOW OR BECOME
AVAILABLE IN THE FUTURE WHEREVER APPLICABLE.

 

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(B)                                 ARQULE BACKGROUND TECHNOLOGY.  ARQULE, AT
ITS SOLE EXPENSE AND ACTING THROUGH PATENT COUNSEL OR AGENTS OF ITS CHOICE,
SHALL BE RESPONSIBLE FOR THE PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF
ALL PATENT RIGHTS COVERING ARQULE BACKGROUND TECHNOLOGY.

 

9.1.3                                 JOINT PROSECUTION.  IN THE CASE OF JOINT
PATENT RIGHTS, THE PARTIES SHALL MEET THROUGH THE PATENT COORDINATORS, OR HOLD A
TELECONFERENCE OR VIDEOCONFERENCE, TO DISCUSS IN GOOD FAITH AND AGREE UPON THE
CONTENT AND FORM OF ANY APPLICATION FOR A JOINT PATENT RIGHT AND HEREBY AGREE
THAT ONLY THE APPLICATION IN THE FORM AS AGREED BETWEEN THE PARTIES MAY BE FILED
IN RESPECT OF THE JOINT PATENT RIGHTS.  ANY DISPUTE BETWEEN THE PATENT
COORDINATORS SHALL BE REFERRED TO THE JEC FOR RESOLUTION PURSUANT TO
SECTION 2.1.5.  THE PARTIES SHALL SHARE THE COSTS EQUALLY IN RESPECT OF THE
PREPARATION OF THE APPLICATION, FILING, PROSECUTION, GRANT AND MAINTENANCE OF
ANY JOINT PATENT RIGHT JOINTLY FILED; AND JOINTLY INSTRUCT AN APPROPRIATELY
QUALIFIED PATENT ATTORNEY TO DRAFT, FILE AND PROSECUTE THE APPLICATION AND EACH
PARTY WILL HAVE EQUAL CONTROL OVER THE PROSECUTION OF THE FILING SUCH THAT THE
PATENT ATTORNEY WILL ONLY BE ABLE TO ACT ON UNANIMOUS INSTRUCTIONS.  IN THE
EVENT THAT ONE PARTY (I) IS NOT INTERESTED, OR (II) NOT WILLING TO EQUALLY SHARE
THE RELATED COST AND EXPENSE, WITH RESPECT TO ANY JOINT PATENT RIGHTS IN A GIVEN
COUNTRY, THEN THE OTHER PARTY SHALL HAVE THE RIGHT, AT ITS OWN COST AND EXPENSE,
TO FILE FOR AND PROSECUTE SUCH JOINT PATENT RIGHTS IN SUCH COUNTRY IN BOTH
PARTIES’ NAMES.

 

9.1.4                                 INFORMATION AND COOPERATION.  EACH PARTY
THAT HAS RESPONSIBILITY FOR FILING AND PROSECUTING ANY PATENT RIGHTS UNDER THIS
SECTION 9.1 (A “FILING PARTY”) SHALL (A) REGULARLY PROVIDE THE OTHER PARTY (THE
“NON-FILING PARTY”) WITH COPIES OF ALL PATENT APPLICATIONS FILED HEREUNDER FOR
PROGRAM TECHNOLOGY AND OTHER MATERIAL SUBMISSIONS AND CORRESPONDENCE WITH THE
PATENT OFFICES, IN SUFFICIENT TIME TO ALLOW FOR REVIEW AND COMMENT BY THE
NON-FILING PARTY; AND (B) PROVIDE THE NON-FILING PARTY AND ITS PATENT COUNSEL
WITH AN OPPORTUNITY TO CONSULT WITH THE FILING PARTY AND ITS PATENT COUNSEL
REGARDING THE FILING AND CONTENTS OF ANY SUCH APPLICATION, AMENDMENT, SUBMISSION
OR RESPONSE.  THE ADVICE AND SUGGESTIONS OF THE NON-FILING PARTY AND ITS PATENT
COUNSEL SHALL BE TAKEN INTO CONSIDERATION IN GOOD FAITH BY SUCH FILING PARTY AND
ITS PATENT COUNSEL IN CONNECTION WITH SUCH FILING.  EACH FILING PARTY SHALL
PURSUE IN GOOD FAITH ALL REASONABLE CLAIMS AND TAKE SUCH OTHER REASONABLE
ACTIONS, AS MAY BE REQUESTED BY THE NON-FILING PARTY IN THE PROSECUTION OF ANY
PATENT RIGHTS COVERING ANY PROGRAM TECHNOLOGY UNDER THIS

 

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SECTION 9.1; PROVIDED, HOWEVER, IF THE FILING PARTY INCURS ANY ADDITIONAL
EXPENSE AS A RESULT OF ANY SUCH REQUEST, THE NON-FILING PARTY SHALL BE
RESPONSIBLE FOR THE COST AND EXPENSES OF PURSUING ANY SUCH ADDITIONAL CLAIM OR
TAKING SUCH OTHER ACTIVITIES.  IN ADDITION, DS AGREES THAT IF ARQULE CLAIMS ANY
ACTION TAKEN UNDER SECTION 9.1.1(A) WOULD BE DETRIMENTAL TO PATENT RIGHTS
COVERING ARQULE BACKGROUND TECHNOLOGY (INCLUDING WITHOUT LIMITATION THE AKIP
PLATFORM TECHNOLOGY), ARQULE SHALL PROVIDE WRITTEN NOTICE TO DS AND THE PATENT
COORDINATORS SHALL, AS PROMPTLY AS POSSIBLE THEREAFTER, MEET TO DISCUSS AND
RESOLVE SUCH MATTER AND, IF THEY ARE UNABLE TO RESOLVE SUCH MATTER, THE PARTIES
SHALL REFER SUCH MATTER TO A MUTUALLY AGREEABLE OUTSIDE PATENT COUNSEL FOR
RESOLUTION.

 

9.1.5                                 ABANDONMENT.

 

(A)                                  PATENT RIGHTS OWNED SOLELY BY ARQULE OR
DS.  IF A FILING PARTY DECIDES TO ABANDON OR TO ALLOW TO LAPSE ANY OF THE PATENT
RIGHTS COVERING ANY PROGRAM TECHNOLOGY FOR WHICH IT HAS RESPONSIBILITY, IT SHALL
INFORM THE NON-FILING PARTY OF SUCH DECISION PROMPTLY AND, IN ANY EVENT, SO AS
TO PROVIDE THE NON-FILING PARTY A REASONABLE AMOUNT OF TIME TO MEET ANY
APPLICABLE DEADLINE TO ESTABLISH OR PRESERVE SUCH PATENT RIGHTS IN SUCH COUNTRY
OR REGION.  THE NON-FILING PARTY SHALL HAVE THE RIGHT TO ASSUME RESPONSIBILITY
FOR CONTINUING THE PROSECUTION OF SUCH PATENT RIGHTS IN SUCH COUNTRY OR REGION
AND PAYING ANY REQUIRED FEES TO MAINTAIN SUCH PATENT RIGHTS IN SUCH COUNTRY OR
REGION OR DEFENDING SUCH PATENT RIGHTS, THROUGH PATENT COUNSEL OR AGENTS OF ITS
CHOICE, WHICH SHALL BE AT THE NON-FILING PARTY’S SOLE EXPENSE.  THE NON-FILING
PARTY SHALL NOT BECOME AN ASSIGNEE OF ANY SUCH PATENT RIGHTS AS A RESULT OF ITS
ASSUMPTION OF ANY SUCH RESPONSIBILITY.  UPON TRANSFER OF SUCH RESPONSIBILITY
UNDER THIS SECTION 9.1.5(A), THE FILING PARTY SHALL PROMPTLY DELIVER TO THE
NON-FILING PARTY COPIES OF ALL NECESSARY FILES RELATED TO THE PATENT RIGHTS WITH
RESPECT TO WHICH RESPONSIBILITY HAS BEEN TRANSFERRED AND SHALL TAKE ALL ACTIONS
AND EXECUTE ALL DOCUMENTS REASONABLY NECESSARY FOR THE NON-FILING PARTY TO
ASSUME SUCH RESPONSIBILITY.

 

(B)                                 JOINT PATENT RIGHTS.  IF ONE PARTY DECIDES
TO ABANDON ITS SHARE OF THE JOINT PATENT RIGHTS IN ANY COUNTRY OR REGION (AN
“ABANDONING PARTY”), IT SHALL INFORM THE OTHER PARTY (THE “MAINTAINING PARTY”)
OF SUCH DECISION PROMPTLY.  THE MAINTAINING PARTY SHALL HAVE THE RIGHT TO ASSUME
ALL RESPONSIBILITY FOR CONTINUING THE PROSECUTION OF SUCH PATENT RIGHTS IN

 

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SUCH COUNTRY OR REGION AND PAYING ANY REQUIRED FEES TO MAINTAIN SUCH PATENT
RIGHTS IN SUCH COUNTRY OR REGION OR DEFENDING SUCH PATENT RIGHTS, THROUGH PATENT
COUNSEL OF ITS CHOICE, WHICH SHALL BE AT THE MAINTAINING PARTY’S SOLE EXPENSE. 
UPON ABANDONMENT OF THE ABANDONING  PARTY’S SHARE OF ANY JOINT PATENT RIGHTS
UNDER THIS SECTION 9.1.5(B), THE ABANDONING PARTY SHALL TAKE ALL ACTIONS AND
EXECUTE ALL DOCUMENTS REASONABLY NECESSARY FOR THE MAINTAINING PARTY TO ASSUME
SUCH RESPONSIBILITY.

 

9.2                                 LEGAL ACTIONS.

 

9.2.1                                 THIRD PARTY INFRINGEMENT.

 

(A)                                  NOTICE.  IN THE EVENT EITHER PARTY BECOMES
AWARE OF (I) ANY POSSIBLE INFRINGEMENT OF ANY LICENSED PATENT RIGHTS, DS PATENT
RIGHTS OR JOINT PATENT RIGHTS THROUGH THE DEVELOPMENT OR COMMERCIALIZATION OF A
PRIMARY DEVELOPMENT COMPOUND, BACKUP COMPOUND OR LICENSED PRODUCT, OR (II) THE
SUBMISSION BY ANY THIRD PARTY OF AN ABBREVIATED NEW DRUG APPLICATION UNDER THE
HATCH-WAXMAN ACT FOR A PRODUCT THAT INCLUDES A LICENSED PRODUCT OR PRIMARY
DEVELOPMENT COMPOUND OR BACKUP COMPOUND (EACH, AN “INFRINGEMENT”), THAT PARTY
SHALL PROMPTLY NOTIFY THE OTHER PARTY AND PROVIDE IT WITH ALL DETAILS OF SUCH
INFRINGEMENT OF WHICH IT IS AWARE (EACH, AN “INFRINGEMENT NOTICE”).

 

(B)                                 DS RIGHT TO ENFORCE.

 

(I)                                     ENFORCEMENT OF DS PATENT RIGHTS.  IN THE
EVENT THAT ANY INFRINGEMENT RELATES TO ANY DS PATENT RIGHTS, THEN, SUBJECT TO
SECTION 9.2.1(B)(II), DS SHALL HAVE THE SOLE RIGHT BUT NOT THE OBLIGATION TO
ENFORCE SUCH CLAIM.

 

(II)                                  ENFORCEMENT OF PROGRAM PATENT RIGHTS.  IN
THE EVENT THAT ANY INFRINGEMENT RELATES TO ANY THIRD PARTY PRODUCT THAT MEETS
CLAUSES (I) AND (II) OF THE MINIMUM REQUIREMENTS FOR A DS TARGET, THEN, SUBJECT
TO SECTION 9.2.1(C) AND 9.2.1(D), DS SHALL HAVE THE FIRST RIGHT (BUT NOT THE
OBLIGATION) TO ENFORCE SUCH CLAIM, WHICH MAY INCLUDE THE INSTITUTION OF LEGAL
PROCEEDINGS OR OTHER ACTION; PROVIDED, THAT, NOTWITHSTANDING THE FOREGOING, DS
SHALL NOT ADMIT THE INVALIDITY OR UNENFORCEABILITY OF ANY LICENSED PATENT RIGHTS
OR VALID CLAIMS THEREIN WITHOUT ARQULE’S PRIOR WRITTEN CONSENT.  DS SHALL KEEP
ARQULE REASONABLY INFORMED ON A QUARTERLY BASIS, IN PERSON OR BY TELEPHONE,
PRIOR TO AND DURING ANY SUCH ENFORCEMENT. 

 

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ARQULE SHALL ASSIST DS, UPON REQUEST, IN TAKING ANY ACTION TO ENFORCE ANY SUCH
PATENT RIGHTS AND SHALL JOIN IN ANY SUCH ACTION IF DEEMED TO BE A NECESSARY
PARTY.  ALL COSTS, INCLUDING WITHOUT LIMITATION ATTORNEYS’ FEES, RELATING TO
SUCH LEGAL PROCEEDINGS OR OTHER ACTION SHALL BE BORNE BY DS.  IF DS DOES NOT
TAKE COMMERCIALLY REASONABLE STEPS TO ABATE THE INFRINGEMENT OF SUCH PATENT
RIGHTS WITHIN * (*) DAYS FROM ANY INFRINGEMENT NOTICE (OR * (*) DAYS IN THE CASE
OF AN INFRINGEMENT RESULTING FROM THE SUBMISSION BY ANY THIRD PARTY OF AN
ABBREVIATED NEW DRUG APPLICATION UNDER THE HATCH-WAXMAN ACT), THEN ARQULE SHALL
HAVE THE RIGHT AND OPTION TO DO SO AT ITS EXPENSE.

 

(C)                                  ARQULE RIGHT TO ENFORCE.

 

(I)                                     ENFORCEMENT OF ARQULE BACKGROUND PATENT
RIGHTS.  IN THE EVENT THAT ANY INFRINGEMENT RELATES TO ANY PATENT RIGHTS
COVERING ARQULE BACKGROUND TECHNOLOGY, ARQULE SHALL HAVE THE SOLE RIGHT BUT NOT
THE OBLIGATION TO ENFORCE SUCH CLAIM.

 

(II)                                  ENFORCEMENT OF ARQULE PROGRAM PATENT
RIGHTS.  IN THE EVENT THAT ANY INFRINGEMENT RELATES TO ANY PATENT RIGHTS
COVERING ARQULE PROGRAM TECHNOLOGY (“ARQULE PROGRAM PATENT RIGHT”), THEN,
SUBJECT TO SECTION 9.2.1(B)(II), ARQULE SHALL HAVE THE FIRST RIGHT (BUT NOT THE
OBLIGATION) TO ENFORCE SUCH CLAIM, WHICH MAY INCLUDE THE INSTITUTION OF LEGAL
PROCEEDINGS OR OTHER ACTION.  ARQULE SHALL KEEP DS REASONABLY INFORMED ON A
QUARTERLY BASIS, IN PERSON OR BY TELEPHONE, PRIOR TO AND DURING ANY SUCH
ENFORCEMENT.  DS SHALL ASSIST ARQULE, UPON REQUEST, IN TAKING ANY ACTION TO
ENFORCE ANY SUCH PATENT RIGHTS AND SHALL JOIN IN ANY SUCH ACTION IF DEEMED TO BE
A NECESSARY PARTY.  ARQULE SHALL INCUR NO LIABILITY TO DS AS A CONSEQUENCE OF
SUCH LITIGATION OR ANY UNFAVORABLE DECISION RESULTING THEREFROM, INCLUDING ANY
DECISION HOLDING ANY SUCH CLAIM INVALID, NOT INFRINGED OR UNENFORCEABLE.  ALL
COSTS, INCLUDING WITHOUT LIMITATION ATTORNEYS’ FEES, RELATING TO SUCH LEGAL
PROCEEDINGS OR OTHER ACTION SHALL BE BORNE BY ARQULE.  IF ARQULE DOES NOT TAKE
COMMERCIALLY REASONABLE STEPS TO ABATE THE INFRINGEMENT OF SUCH PATENT RIGHTS
WITHIN * (*) DAYS FROM ANY INFRINGEMENT NOTICE (OR * (*) DAYS IN THE CASE OF AN
INFRINGEMENT RESULTING FROM THE SUBMISSION BY ANY THIRD PARTY OF AN ABBREVIATED
NEW DRUG APPLICATION UNDER THE HATCH-WAXMAN ACT), THEN DS SHALL HAVE THE RIGHT
AND OPTION TO DO SO AT ITS EXPENSE.  FOR PURPOSES OF CLARITY,

 

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NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, DS SHALL HAVE NO RIGHT TO
ENFORCE ANY ARQULE PATENTS RIGHTS COVERING THE AKIP PLATFORM TECHNOLOGY.

 

(D)                                 JOINT PATENT RIGHTS.  IN THE EVENT OF AN
INFRINGEMENT OF A JOINT PATENT RIGHT, THEN, SUBJECT TO SECTION 9.2.1(B)(II), THE
PARTIES SHALL ENTER INTO GOOD FAITH DISCUSSIONS AS TO WHETHER AND HOW TO
ELIMINATE THE INFRINGEMENT.  SUBJECT TO THE FOREGOING, (I) DS SHALL HAVE THE
FIRST RIGHT AND OPTION TO ELIMINATE SUCH INFRINGEMENT IN THE FIELD AND ARQULE
SHALL HAVE THE FIRST RIGHT AND OPTION TO ELIMINATE SUCH INFRINGEMENT OUTSIDE THE
FIELD, IN EACH CASE BY REASONABLE STEPS, WHICH MAY INCLUDE THE INSTITUTION OF
LEGAL PROCEEDINGS OR OTHER ACTION AND (II) ALL COSTS, INCLUDING WITHOUT
LIMITATION ATTORNEYS’ FEES, RELATING TO SUCH LEGAL PROCEEDINGS OR OTHER ACTION
SHALL BE BORNE BY SUCH PARTY.  NEITHER DS NOR ARQULE SHALL ADMIT THE INVALIDITY
OR UNENFORCEABILITY OF ANY JOINT PATENT RIGHTS OR VALID CLAIMS THEREIN WITHOUT
THE OTHER PARTY’S PRIOR WRITTEN CONSENT.  IF DS OR ARQULE DOES NOT TAKE OR
INITIATE COMMERCIALLY REASONABLE STEPS TO ELIMINATE THE INFRINGEMENT WITHIN *
(*) DAYS FROM ANY INFRINGEMENT NOTICE (OR * (*) DAYS IN THE CASE OF AN
INFRINGEMENT RESULTING FROM THE SUBMISSION BY ANY THIRD PARTY OF AN ABBREVIATED
NEW DRUG APPLICATION UNDER THE HATCH-WAXMAN ACT), THEN THE OTHER PARTY SHALL
HAVE THE RIGHT AND OPTION TO DO SO AT ITS EXPENSE.

 

(E)                                  REPRESENTATION OF EITHER PARTY.  EACH PARTY
SHALL HAVE THE RIGHT TO BE REPRESENTED BY COUNSEL THAT IT SELECTS IN ANY LEGAL
PROCEEDINGS OR OTHER ACTION INSTITUTED UNDER THIS SECTION 9.2.1 BY THE OTHER
PARTY.

 

(F)                                    COOPERATION BY THE PARTIES.  IN ANY
ACTION, SUIT OR PROCEEDING INSTITUTED UNDER THIS SECTION 9.2.1, THE PARTIES
SHALL COOPERATE WITH AND ASSIST EACH OTHER IN ALL REASONABLE RESPECTS.  UPON THE
REASONABLE REQUEST OF THE PARTY INSTITUTING SUCH ACTION, SUIT OR PROCEEDING, THE
OTHER PARTY SHALL JOIN SUCH ACTION, SUIT OR PROCEEDING AND SHALL BE REPRESENTED
USING COUNSEL OF ITS OWN CHOICE, AT THE REQUESTING PARTY’S EXPENSE.  IF A PARTY
WITH THE RIGHT TO INITIATE LEGAL PROCEEDINGS UNDER THIS SECTION 9.2.1 LACKS
STANDING TO DO SO AND THE OTHER PARTY HAS STANDING TO INITIATE SUCH LEGAL
PROCEEDINGS, THEN THE PARTY WITH STANDING SHALL INITIATE SUCH LEGAL PROCEEDINGS
AT THE REQUEST AND EXPENSE OF THE OTHER PARTY.

 

(G)                                 ALLOCATION OF RECOVERIES.  ANY AMOUNTS
RECOVERED BY DS PURSUANT TO ACTIONS UNDER SECTIONS 9.2.1(B)(II) OR 9.2.1(D),
WHETHER BY SETTLEMENT OR JUDGMENT, SHALL BE

 

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ALLOCATED IN THE FOLLOWING ORDER: (I) FIRST, TO REIMBURSE DS AND ARQULE FOR
THEIR REASONABLE OUT-OF-POCKET EXPENSES IN MAKING SUCH RECOVERY (WHICH AMOUNTS
SHALL BE ALLOCATED PRO RATA IF INSUFFICIENT TO COVER THE TOTALITY OF SUCH
EXPENSES); AND (II) SECOND (A) WITH RESPECT TO ACTUAL DAMAGES, TO DS AND ARQULE
IN THE *, AND (B) WITH RESPECT TO PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES, *
PERCENT (*%) TO DS AND * PERCENT (*%) TO ARQULE.  ANY AMOUNTS RECOVERED BY
ARQULE PURSUANT TO ACTIONS UNDER SECTION 9.2.1(C)(II) OR 9.2.1(D) SHALL BE
ALLOCATED IN THE FOLLOWING ORDER: (X) FIRST, TO REIMBURSE ARQULE AND DS FOR
THEIR REASONABLE OUT OF POCKET EXPENSES IN MAKING SUCH RECOVERY (WHICH AMOUNTS
SHALL BE ALLOCATED PRO RATA IF INSUFFICIENT TO COVER THE TOTALITY OF SUCH
EXPENSES); AND (Y) THEN, *% TO ARQULE.

 

9.2.2                                 DEFENSE OF CLAIMS.

 

(A)                                  NOTICE.  IN THE EVENT THAT A THIRD PARTY
ALLEGES THAT THE CONDUCT OF THE RESEARCH PROGRAM OR THE DEVELOPMENT OR
COMMERCIALIZATION OF A PRIMARY DEVELOPMENT COMPOUND, BACKUP COMPOUND OR LICENSED
PRODUCT INFRINGES THE PATENT RIGHTS OF A THIRD PARTY, THE PARTY BECOMING AWARE
OF SUCH ALLEGATION SHALL PROMPTLY NOTIFY THE OTHER PARTY HEREOF, IN WRITING,
REASONABLY DETAILING THE CLAIM.

 

(B)                                 THIRD PARTY SUIT RELATING PRIMARILY TO DS
TARGETS OR LICENSED PRODUCTS.  IN THE EVENT THAT ANY ACTION, SUIT OR PROCEEDING
IS BROUGHT AGAINST EITHER PARTY OR ANY AFFILIATE OR SUBLICENSEE OF EITHER PARTY
ALLEGING THE INFRINGEMENT OF THE PATENT RIGHTS OF A THIRD PARTY RELATING
SPECIFICALLY TO THE DS TARGETS OR LICENSED PRODUCTS BY REASON OF ACTIVITIES
CONDUCTED PURSUANT TO THIS AGREEMENT, (I) DS SHALL HAVE THE RIGHT AND OBLIGATION
TO DEFEND OR OTHERWISE RESOLVE SUCH ACTION, SUIT OR PROCEEDING (E.G., BY WAY OF
ENTERING INTO A SETTLEMENT AGREEMENT OR CONSENT) AT ITS SOLE EXPENSE;
(II) ARQULE OR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL HAVE THE RIGHT TO
SEPARATE COUNSEL AT ITS OWN EXPENSE IN ANY SUCH ACTION, SUIT OR PROCEEDING AND,
IF SUCH ACTION, SUIT OR PROCEEDING HAS BEEN BROUGHT AGAINST ARQULE OR ANY OF ITS
AFFILIATES OR SUBLICENSEES, ARQULE MAY ELECT TO DEFEND ITSELF AT ITS SOLE
EXPENSE; AND (III) THE PARTIES SHALL COOPERATE WITH EACH OTHER IN ALL REASONABLE
RESPECTS IN ANY SUCH ACTION, SUIT OR PROCEEDING.  SETTLEMENT COSTS, ROYALTIES
PAID IN SETTLEMENT OF ANY SUCH SUIT, AND THE PAYMENT OF ANY DAMAGES

 

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TO THE THIRD PARTY SHALL BE BORNE SOLELY BY DS, PROVIDED THAT DS SHALL BE
ENTITLED TO CREDIT * PERCENT (*%) OF SUCH PAYMENTS AGAINST MILESTONE PAYMENTS OR
ROYALTY PAYMENTS TO BE PAID BY DS UNDER THE LICENSE AGREEMENT RELATING TO SUCH
LICENSED PRODUCT.

 

(C)                                  THIRD PARTY SUIT RELATING PRIMARILY TO THE
USE OF THE AKIP PLATFORM TECHNOLOGY.  IN THE EVENT THAT ANY ACTION, SUIT OR
PROCEEDING IS BROUGHT AGAINST EITHER PARTY OR ANY AFFILIATE OR SUBLICENSEE OF
EITHER PARTY ALLEGING THE INFRINGEMENT OF THE PATENT RIGHTS OF A THIRD PARTY BY
REASON OF THE USE OF THE AKIP PLATFORM TECHNOLOGY IN THE CONDUCT OF THE RESEARCH
PROGRAM (I) ARQULE SHALL HAVE THE RIGHT AND OBLIGATION TO DEFEND OR OTHERWISE
RESOLVE SUCH ACTION, SUIT OR PROCEEDING (E.G., BY WAY OF ENTERING INTO A
SETTLEMENT AGREEMENT OR CONSENT) AT ITS SOLE EXPENSE; AND (II) DS OR ANY OF ITS
AFFILIATES OR SUBLICENSEES SHALL HAVE THE RIGHT TO SEPARATE COUNSEL AT ITS OWN
EXPENSE IN ANY SUCH ACTION, SUIT OR PROCEEDING AND, IF SUCH ACTION, SUIT OR
PROCEEDING HAS BEEN BROUGHT AGAINST DS OR ANY OF ITS AFFILIATES OR SUBLICENSEES,
DS OR ITS AFFILIATE OR SUBLICENSEE MAY ELECT TO DEFEND ITSELF AT ITS SOLE
EXPENSE.  SETTLEMENT COSTS, ROYALTIES PAID IN SETTLEMENT OF ANY SUCH SUIT, AND
THE PAYMENT OF ANY DAMAGES TO THE THIRD PARTY SHALL BE BORNE SOLELY BY ARQULE.

 

(D)                                 COOPERATION IN DEFENSE.  THE PARTIES SHALL
COOPERATE WITH EACH OTHER IN ALL REASONABLE RESPECTS IN ANY ACTION, SUIT OR
PROCEEDING UNDER THIS SECTION 9.2.2.  EACH PARTY SHALL PROVIDE THE OTHER PARTY
WITH PROMPT WRITTEN NOTICE OF THE COMMENCEMENT OF ANY SUCH SUIT, ACTION OR
PROCEEDING, OR OF ANY EVIDENCE OR ALLEGATION OF INFRINGEMENT OF WHICH SUCH PARTY
BECOMES AWARE, AND SHALL PROMPTLY FURNISH THE OTHER PARTY WITH A COPY OF EACH
COMMUNICATION RELATING TO THE ALLEGED INFRINGEMENT THAT IS RECEIVED BY SUCH
PARTY.  THE PARTY THAT IS A PARTY TO THE ACTION, SUIT OR PROCEEDING SHALL NOT
ADMIT THE INVALIDITY OF ANY PATENT WITHIN THE LICENSED PATENT RIGHTS, JOINT
PATENT RIGHTS OR DS PATENT RIGHTS, NOR SETTLE SUCH ACTION, SUIT OR PROCEEDING IN
A MANNER THAT ADVERSELY AFFECTS THE OTHER PARTY’S RIGHTS UNDER THIS AGREEMENT,
WITHOUT THE WRITTEN CONSENT OF THE OTHER PARTY, WHICH CONSENT SHALL NOT BE
UNREASONABLY WITHHELD, DELAYED OR CONDITIONED.

 

9.3                                 TRADEMARK AND COPYRIGHT PROSECUTION, DEFENSE
AND ENFORCEMENT.  DS SHALL BE RESPONSIBLE FOR THE FILING, PROSECUTION,
MAINTENANCE, DEFENSE AND ENFORCEMENT OF ALL LICENSED

 

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PRODUCT TRADEMARKS AND COPYRIGHTS CREATED DURING THE RESEARCH PROGRAM,
DEVELOPMENT AND/OR COMMERCIALIZATION AT DS’S EXPENSE.

 

10.                               TERM AND TERMINATION

 

10.1                           TERM.  THE TERM (“TERM”) OF THIS AGREEMENT SHALL
COMMENCE ON THE EFFECTIVE DATE AND SHALL CONTINUE IN FULL FORCE AND EFFECT UNTIL
THE LATER OF (I) THE END OF THE RESEARCH COLLABORATION PERIOD, OR (II) THE
EXPIRATION OF THE LAST TO EXPIRE DS OPTION PERIOD AND, IF DS IS DEVELOPING A
LICENSED PRODUCT OR COMMERCIALIZING A LICENSED PRODUCT (INCLUDING ANY
CO-COMMERCIALIZED LICENSED PRODUCT), THEREAFTER UNTIL (A) SUCH TIME AS DS IS NO
LONGER DEVELOPING AT LEAST ONE (1) LICENSED PRODUCT OR (B) IF, AS OF THE TIME DS
IS NO LONGER DEVELOPING AT LEAST ONE (1) LICENSED PRODUCT, DS IS COMMERCIALIZING
A LICENSED PRODUCT, SUCH TIME AS ALL ROYALTY TERMS FOR ALL LICENSED PRODUCTS
HAVE ENDED, WHICHEVER IS LATER, UNLESS EARLIER TERMINATED IN ACCORDANCE WITH THE
PROVISIONS OF THIS ARTICLE 10.

 

10.2                           TERMINATION.  THIS AGREEMENT MAY BE TERMINATED AT
ANY TIME BY EITHER PARTY AS FOLLOWS:

 

10.2.1                           UNILATERAL RIGHT TO TERMINATE.  DS MAY
TERMINATE THIS AGREEMENT, EFFECTIVE UPON NOT LESS THAN NINETY (90) DAYS WRITTEN
NOTICE TO ARQULE, AT ANY TIME ON OR AFTER EXPIRATION OF THE RESEARCH
COLLABORATION PERIOD.

 

10.2.2                           TERMINATION FOR BREACH.  SUBJECT TO
SECTION 13.1.1(D), EITHER PARTY MAY TERMINATE THIS AGREEMENT, EFFECTIVE
IMMEDIATELY UPON WRITTEN NOTICE TO THE OTHER PARTY, FOR A MATERIAL BREACH BY THE
OTHER PARTY OF ANY TERM OF THIS AGREEMENT THAT REMAINS UNCURED FOR * (*) DAYS *
(*) DAYS IN THE EVENT THAT THE BREACH IS A FAILURE OF EITHER PARTY TO MAKE ANY
PAYMENT REQUIRED HEREUNDER) AFTER THE NON-BREACHING PARTY FIRST GIVES WRITTEN
NOTICE TO THE OTHER PARTY OF SUCH BREACH AND ITS INTENT TO TERMINATE THIS
AGREEMENT IF SUCH BREACH IS NOT CURED; PROVIDED, THAT, IN THE EVENT DS IS IN
BREACH OF ITS DILIGENCE OBLIGATIONS WITH RESPECT TO A GIVEN DS TARGET AND/OR ANY
LICENSED PRODUCT AGAINST SUCH DS TARGET, ARQULE SHALL ONLY HAVE THE RIGHT TO
TERMINATE THE LICENSE WITH RESPECT TO SUCH DS TARGET AND/OR LICENSED PRODUCT
(BUT LEAVING UNAFFECTED DS’S RIGHTS UNDER THIS AGREEMENT TO ANY OTHER DS TARGET
AND LICENSED PRODUCT DIRECTED AGAINST SUCH OTHER DS TARGET).

 

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10.2.3                           TERMINATION FOR INSOLVENCY.  IN THE EVENT THAT
EITHER PARTY FILES FOR PROTECTION UNDER BANKRUPTCY LAWS, MAKES A GENERAL
ASSIGNMENT FOR THE BENEFIT OF CREDITORS, APPOINTS OR SUFFERS APPOINTMENT OF A
RECEIVER OR TRUSTEE OVER ITS BUSINESS, FILES A PETITION UNDER ANY BANKRUPTCY OR
INSOLVENCY ACT OR HAS ANY SUCH PETITION FILED AGAINST IT WHICH IS NOT DISMISSED
OR STAYED WITHIN * (*) DAYS OF THE FILING THEREOF, THE OTHER PARTY MAY TERMINATE
THIS AGREEMENT EFFECTIVE IMMEDIATELY UPON WRITTEN NOTICE TO SUCH PARTY.  IN
CONNECTION THEREWITH, ALL RIGHTS AND LICENSES GRANTED UNDER THIS AGREEMENT ARE,
AND SHALL BE DEEMED TO BE, FOR PURPOSES OF SECTION 365(N) OF THE UNITED STATES
BANKRUPTCY CODE, LICENSES OF RIGHTS TO “INTELLECTUAL PROPERTY” AS DEFINED UNDER
SECTION 101(35A) OF THE UNITED STATES BANKRUPTCY CODE.

 

10.2.4                           TERMINATION FOR CHALLENGE.  EXCEPT TO THE
EXTENT THE FOLLOWING IS UNENFORCEABLE UNDER THE LAW OF A PARTICULAR JURISDICTION
WHERE A PATENT APPLICATION WITHIN THE LICENSED PATENT RIGHTS IS PENDING OR A
PATENT WITHIN THE LICENSED PATENT RIGHTS ISSUED, IN THE EVENT DS, ITS AFFILIATES
AND/OR SUBLICENSEES INITIATES A CHALLENGE OR ASSISTS A THIRD PARTY IN INITIATING
A CHALLENGE, ARQULE SHALL HAVE THE RIGHT TO TERMINATE THIS AGREEMENT, EFFECTIVE
IMMEDIATELY UPON WRITTEN NOTICE TO DS.

 

10.3                           CONSEQUENCES OF TERMINATION OF AGREEMENT.  IN THE
EVENT OF THE TERMINATION OF THIS AGREEMENT PURSUANT TO SECTION 10.2, THE
FOLLOWING PROVISIONS SHALL APPLY, AS APPLICABLE TO THIS AGREEMENT AND SHALL BE
INCLUDED IN ANY LICENSE AGREEMENT EXECUTED UPON EXERCISE OF A DS OPTION.

 

10.3.1                           TERMINATION PURSUANT TO SECTION 10.2.1.  IF
THIS AGREEMENT IS TERMINATED BY DS PURSUANT TO SECTION 10.2.1:

 

(A)                                  ALL LICENSES GRANTED TO DS UNDER ARTICLE 7
TO ANY LICENSED PRODUCTS AS OF THE EFFECTIVE DATE OF TERMINATION, IF ANY, SHALL
IMMEDIATELY TERMINATE AND ALL SUCH LICENSED PRODUCTS AND THE COLLABORATION
COMPOUNDS THEREIN SHALL BE DEEMED TO BE TERMINATED COMPOUNDS, AND ARQULE SHALL
HAVE NO FURTHER OBLIGATIONS UNDER SECTION 7.7.1.

 

(B)                                 EACH PARTY SHALL PROMPTLY RETURN ALL
CONFIDENTIAL INFORMATION AND PROPRIETARY MATERIALS OF THE OTHER PARTY THAT ARE
NOT SUBJECT TO A CONTINUING LICENSE HEREUNDER; PROVIDED, THAT, EACH PARTY MAY
RETAIN ONE COPY OF THE CONFIDENTIAL INFORMATION OF THE OTHER PARTY

 

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IN ITS ARCHIVES SOLELY FOR THE PURPOSE OF ESTABLISHING THE CONTENTS THEREOF AND
ENSURING COMPLIANCE WITH ITS OBLIGATIONS HEREUNDER.

 

(C)                                  UPON REQUEST OF ARQULE, DS WILL TRANSFER TO
ARQULE ALL OF ITS RIGHT, TITLE AND INTEREST IN TERMINATED COMPOUNDS TO ARQULE. 
WITHOUT LIMITING THE FOREGOING, DS SHALL:

 

(I)                                     ASSIGN , FREE OF CHARGE, TO ARQULE THE
OWNERSHIP OF ALL LICENSED PRODUCT TRADEMARKS APPLICABLE TO THE TERMINATED
COMPOUNDS; PROVIDED THAT AFTER SUCH ASSIGNMENT, ARQULE SHALL ASSUME ALL
RESPONSIBILITY FOR MAINTAINING SUCH LICENSED PRODUCT TRADEMARKS, AND IF ARQULE
DOES NOT REQUEST SUCH ASSIGNMENT, DS MAY TERMINATE OR WITHDRAW FROM REGISTRATION
ALL SUCH LICENSED PRODUCT TRADEMARKS;

 

(II)                                  ASSIGN TO ARQULE, FREE OF CHARGE, OR AT
DS’S CHOICE, GRANT TO ARQULE AN EXCLUSIVE, WORLDWIDE, ROYALTY-FREE LICENSE, WITH
THE UNRESTRICTED RIGHT TO SUBLICENSE, UNDER ALL DS PATENT RIGHTS AND DS
TECHNOLOGY SPECIFIC TO THE  PRIMARY DEVELOPMENT COMPOUNDS AND RELATED BACKUP
COMPOUNDS AND GRANT TO ARQULE A NON-EXCLUSIVE WORLDWIDE, ROYALTY-FREE LICENSE,
WITH THE UNRESTRICTED RIGHT TO SUBLICENSE, UNDER ALL OTHER DS PATENT RIGHTS AND
DS TECHNOLOGY NECESSARY OR USEFUL FOR ARQULE TO DEVELOP AND COMMERCIALIZE THE
LICENSED PRODUCTS AND THE PRIMARY DEVELOPMENT COMPOUNDS AND RELATED BACKUP
COMPOUNDS;

 

(III)                               TRANSFER TO ARQULE ALL OF ITS RIGHT, TITLE
AND INTEREST IN ALL REGULATORY FILINGS, DRUG APPROVAL APPLICATIONS AND
REGULATORY APPROVALS THEN IN ITS NAME APPLICABLE TO THE TERMINATED COMPOUNDS, IF
ANY;

 

(IV)                              NOTIFY THE APPLICABLE REGULATORY AUTHORITIES
AND TAKE ANY OTHER ACTION REASONABLY NECESSARY TO EFFECT SUCH TRANSFER;

 

(V)                                 PROVIDE ARQULE WITH COPIES OF ALL
CORRESPONDENCE BETWEEN DS AND SUCH REGULATORY AUTHORITIES RELATING TO SUCH
REGULATORY FILINGS, DRUG APPROVAL APPLICATIONS AND REGULATORY APPROVALS;

 

(VI)                              UNLESS EXPRESSLY PROHIBITED BY ANY REGULATORY
AUTHORITY, TRANSFER CONTROL TO ARQULE OF ALL CLINICAL TRIALS OF THE TERMINATED
COMPOUNDS BEING CONDUCTED

 

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AS OF THE EFFECTIVE DATE OF TERMINATION AND CONTINUE TO CONDUCT SUCH TRIALS AT
ITS EXPENSE FOR UP TO FOUR (4) MONTHS TO ENABLE SUCH TRANSFER TO BE COMPLETED
WITHOUT INTERRUPTION OF ANY SUCH TRIAL, UNLESS ARQULE DEMONSTRATES TO DS TO DS’S
SATISFACTION THAT ARQULE SHALL NOT BE ABLE TO ASSUME SUCH CLINICAL TRIALS WITHIN
FOUR MONTHS, IN WHICH CASE DS SHALL CONTINUE TO CONDUCT SUCH TRIALS FOR UP TO
TWO (2) ADDITIONAL MONTHS;

 

(VII)                           ASSIGN (OR CAUSE ITS AFFILIATES TO ASSIGN) TO
ARQULE ALL AGREEMENTS WITH ANY THIRD PARTY WITH RESPECT TO THE CONDUCT OF
CLINICAL TRIALS FOR THE TERMINATED COMPOUNDS INCLUDING, WITHOUT LIMITATION,
AGREEMENTS WITH CONTRACT RESEARCH ORGANIZATIONS, CLINICAL SITES AND
INVESTIGATORS, UNLESS EXPRESSLY PROHIBITED BY ANY SUCH AGREEMENT (IN WHICH CASE
DS SHALL COOPERATE WITH ARQULE IN ALL REASONABLE RESPECTS TO SECURE THE CONSENT
OF SUCH THIRD PARTY TO SUCH ASSIGNMENT);

 

(VIII)                        PROVIDE ARQULE WITH ALL SUPPLIES OF THE TERMINATED
COMPOUNDS IN THE POSSESSION OF DS OR ANY AFFILIATE OR CONTRACTOR OF DS;

 

(IX)                                PROVIDE ARQULE WITH COPIES OF ALL REPORTS
AND DATA GENERATED OR OBTAINED BY DS OR ITS AFFILIATES PURSUANT TO THIS
AGREEMENT THAT RELATE TO ANY TERMINATED COMPOUNDS THAT HAVE NOT PREVIOUSLY BEEN
PROVIDED TO ARQULE;

 

(X)                                   REIMBURSE ARQULE FOR ALL INTERNAL AND
OUT-OF-POCKET COSTS INCURRED BY ARQULE IN CONTINUING THE RESEARCH AND
DEVELOPMENT OF ALL THE TERMINATED COMPOUNDS FOR A PERIOD OF * (*) DAYS FROM THE
DATE OF THE TERMINATION NOTICE; AND

 

(XI)                                IF DS HAS MANUFACTURED, IS MANUFACTURING OR
HAVING MANUFACTURED ANY TERMINATED COMPOUNDS OR ANY INTERMEDIATE THEREOF: (I) DS
SHALL, IF REQUESTED BY ARQULE, SUPPLY ARQULE WITH ITS REQUIREMENTS FOR ALL
TERMINATED COMPOUNDS AND INTERMEDIATES FOR UP TO * (*) MONTHS FOLLOWING SUCH
TERMINATION AT A TRANSFER PRICE EQUAL TO DS’S FULLY-BURDENED MANUFACTURING COST
FOR THE SUPPLY OF SUCH TERMINATED COMPOUNDS OR INTERMEDIATES, PLUS * PERCENT
(*%), (II) WITHIN * (*) DAYS AFTER ARQULE’S REQUEST, DS SHALL PROVIDE TO ARQULE
OR ITS DESIGNEE ALL INFORMATION IN ITS POSSESSION WITH RESPECT TO THE
MANUFACTURE OF EACH SUCH TERMINATED COMPOUND OR INTERMEDIATE.

 

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(D)                                 ARQULE SHALL REIMBURSE DS FOR ITS ACTUAL
OUT-OF-POCKET COSTS OF COMPLYING WITH SECTION 10.3.1(C)(I), (II), (III), (IV),
(V), (VI), (VII), (VIII) AND (IX), UP TO A TOTAL OF * DOLLARS (US $*).

 

10.3.2                           TERMINATION BY DS PURSUANT TO SECTION 10.2.2. 
IF THIS AGREEMENT IS TERMINATED BY DS PURSUANT TO SECTION 10.2.2, THE LICENSE
GRANTED BY ARQULE TO DS PURSUANT TO SECTION 7.2.1 SHALL SURVIVE SOLELY AS
APPLIED TO COLLABORATION COMPOUNDS SUBJECT TO A DS OPTION AS OF THE EFFECTIVE
DATE OF TERMINATION, IF ANY, IN EACH CASE SUBJECT TO DS’S CONTINUED PAYMENT OF
ALL MILESTONE, ROYALTY, AND OTHER PAYMENTS UNDER AND IN ACCORDANCE WITH THIS
AGREEMENT AND ANY LICENSE AGREEMENT WITH RESPECT THERETO.

 

10.3.3                           TERMINATION BY DS PURSUANT TO SECTION 10.2.3. 
IF THIS AGREEMENT IS TERMINATED BY DS PURSUANT TO SECTION 10.2.3, UNLESS
PROHIBITED BY APPLICABLE LAWS, EACH PARTY SHALL PROMPTLY RETURN ALL CONFIDENTIAL
INFORMATION AND PROPRIETARY MATERIALS OF THE OTHER PARTY THAT ARE NOT SUBJECT TO
A CONTINUING LICENSE HEREUNDER, OR UNDER THE UNITED STATES BANKRUPTCY CODE;
PROVIDED, THAT, EACH PARTY MAY RETAIN ONE COPY OF THE CONFIDENTIAL INFORMATION
OF THE OTHER PARTY IN ITS ARCHIVES SOLELY FOR THE PURPOSE OF ESTABLISHING THE
CONTENTS THEREOF AND ENSURING COMPLIANCE WITH ITS OBLIGATIONS HEREUNDER.

 

10.3.4                           TERMINATION BY ARQULE PURSUANT TO
SECTION 10.2.2.

 

(A)                                  DILIGENCE OBLIGATIONS.  IF DS’S RIGHTS TO A
DS TARGET AND ALL LICENSED PRODUCTS DIRECTED AGAINST SUCH DS TARGET ARE
TERMINATED BY ARQULE PURSUANT TO SECTION 10.2.2 FOR BREACH BY DS OF ITS
DILIGENCE OBLIGATIONS UNDER SECTION 4.7, THE PROVISIONS OF SECTION 10.3.1 SHALL
APPLY BUT ONLY TO THE DS TARGET AND COLLABORATION COMPOUNDS FOR WHICH DS’S
RIGHTS WERE TERMINATED.

 

(B)                                 OTHER OBLIGATIONS.  IF THIS AGREEMENT IS
TERMINATED BY ARQULE PURSUANT TO SECTION 10.2.2 FOR BREACH BY DS OF ITS
OBLIGATIONS UNDER THIS AGREEMENT OTHER THAN ITS DILIGENCE OBLIGATIONS UNDER
SECTION 4.7:

 

(I)                                     THE PROVISIONS OF SECTION 10.3.1 SHALL
APPLY; AND

 

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(II)                                  IF SUCH TERMINATION IS EFFECTIVE PRIOR TO
THE END OF THE RESEARCH COLLABORATION PERIOD, (A) DS SHALL, FOR A PERIOD OF *
FROM THE EFFECTIVE DATE OF TERMINATION, PAY ARQULE THE FTE FUNDING COMMITMENT
AND (B) THE RESEARCH PROGRAM SHALL TERMINATE WITHOUT ANY FURTHER OBLIGATION OF
ARQULE.

 

10.3.5                           TERMINATION BY ARQULE PURSUANT TO
SECTION 10.2.3.  IF THIS AGREEMENT IS TERMINATED BY ARQULE PURSUANT TO
SECTION 10.2.3, UNLESS PROHIBITED BY APPLICABLE LAWS, THE PROVISIONS OF
SECTION 10.3.1 SHALL APPLY, EXCEPT THAT DS SHALL HAVE NO OBLIGATION TO CONTINUE
TO CONDUCT ANY CLINICAL TRIAL.

 

10.3.6                           TERMINATION BY ARQULE PURSUANT TO
SECTION 10.2.4.  IF THIS AGREEMENT IS TERMINATED BY ARQULE PURSUANT TO
SECTION 10.2.4:

 

(A)                                  THE PROVISIONS OF SECTION 10.3.1 SHALL
APPLY; AND

 

(B)                                 IF SUCH TERMINATION IS EFFECTIVE PRIOR TO
THE END OF THE RESEARCH COLLABORATION PERIOD, (I) DS SHALL, FOR A PERIOD OF ONE
HUNDRED TWENTY (120) DAYS FROM THE EFFECTIVE DATE OF TERMINATION, PAY ARQULE THE
FTE FUNDING COMMITMENT AND (II) THE RESEARCH PROGRAM SHALL TERMINATE WITHOUT ANY
FURTHER OBLIGATION OF ARQULE.

 

10.4                           SURVIVING PROVISIONS.  TERMINATION OR EXPIRATION
OF THIS AGREEMENT FOR ANY REASON SHALL BE WITHOUT PREJUDICE TO:

 

(A)                                  THE RIGHTS AND OBLIGATIONS OF THE PARTIES
PROVIDED IN ARTICLES 1, 6, 8, 9 (WITH RESPECT TO JOINT PATENT RIGHTS AND DS
PATENT RIGHTS LICENSED TO ARQULE PURSUANT TO SECTION 10.3.1(C)(II)), 11, 12 AND
13 (EXCEPT SECTION 13.1.2) AND SECTIONS 7.6, 10.3 AND 10.4.

 

(B)                                 UNLESS OTHERWISE PROVIDED FOR IN THIS
AGREEMENT, ARQULE’S RIGHTS TO RECEIVE ROYALTIES AND MILESTONE PAYMENTS FOR THE
DURATION OF ALL APPLICABLE ROYALTY TERMS, IF ANY; AND

 

(C)                                  ANY OTHER RIGHTS OR REMEDIES PROVIDED AT
LAW OR EQUITY WHICH EITHER PARTY MAY OTHERWISE HAVE.

 

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11.                               REPRESENTATIONS AND WARRANTIES

 

11.1                           MUTUAL REPRESENTATIONS AND WARRANTIES.  ARQULE
AND DS EACH REPRESENTS AND WARRANTS TO THE OTHER, AS OF THE EFFECTIVE DATE, AS
FOLLOWS:

 

11.1.1                           ORGANIZATION.  IT IS A CORPORATION DULY
ORGANIZED, VALIDLY EXISTING AND IN GOOD STANDING UNDER THE LAWS OF THE
JURISDICTION OF ITS ORGANIZATION, AND HAS ALL REQUISITE POWER AND AUTHORITY,
CORPORATE OR OTHERWISE, TO EXECUTE, DELIVER AND PERFORM THIS AGREEMENT.

 

11.1.2                           AUTHORIZATION.  THE EXECUTION AND DELIVERY OF
THIS AGREEMENT AND THE PERFORMANCE BY IT OF THE TRANSACTIONS CONTEMPLATED HEREBY
HAVE BEEN DULY AUTHORIZED BY ALL NECESSARY CORPORATE ACTION AND WILL NOT VIOLATE
(A) SUCH PARTY’S CERTIFICATE OF INCORPORATION OR BYLAWS, (B) ANY AGREEMENT,
INSTRUMENT OR CONTRACTUAL OBLIGATION TO WHICH SUCH PARTY IS BOUND IN ANY
MATERIAL RESPECT, (C) ANY REQUIREMENT OF ANY APPLICABLE LAWS, OR (D) ANY ORDER,
WRIT, JUDGMENT, INJUNCTION, DECREE, DETERMINATION OR AWARD OF ANY COURT OR
GOVERNMENTAL AGENCY PRESENTLY IN EFFECT APPLICABLE TO SUCH PARTY.

 

11.1.3                           BINDING AGREEMENT.  THIS AGREEMENT IS A LEGAL,
VALID AND BINDING OBLIGATION OF SUCH PARTY ENFORCEABLE AGAINST IT IN ACCORDANCE
WITH ITS TERMS AND CONDITIONS.

 

11.1.4                           NO INCONSISTENT OBLIGATION.  IT IS NOT UNDER
ANY OBLIGATION, CONTRACTUAL OR OTHERWISE, TO ANY PERSON THAT CONFLICTS WITH OR
IS INCONSISTENT IN ANY RESPECT WITH THE TERMS OF THIS AGREEMENT OR THAT WOULD
IMPEDE THE DILIGENT AND COMPLETE FULFILLMENT OF ITS OBLIGATIONS HEREUNDER.

 

11.2                           ARQULE’S REPRESENTATIONS AND WARRANTIES.  ARQULE
REPRESENTS AND WARRANTS TO DS AS FOLLOWS:

 

11.2.1                           ALL LICENSED TECHNOLOGY EXISTING AS OF THE
EFFECTIVE DATE IS CONTROLLED BY ARQULE.

 

11.2.2                           TO THE ACTUAL KNOWLEDGE OF THE CHIEF EXECUTIVE
OFFICER, THE PRESIDENT, ANY VICE PRESIDENT OR ARQULE’S INTERNAL PATENT COUNSEL,
ARQULE, AS OF THE EFFECTIVE DATE, EXCEPT AS PREVIOUSLY DISCLOSED TO DS, NO THIRD
PARTY HAS INITIATED, OR THREATENED IN WRITING TO INITIATE, ANY LITIGATION
AGAINST ARQULE OR ITS AFFILIATES, INCLUDING, WITHOUT LIMITATION, BY

 

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INITIATING ANY DECLARATORY JUDGMENT LAWSUIT, OR BY SENDING A CEASE-AND-DESIST
LETTER, ALLEGING THAT THE LICENSED PATENT RIGHTS ARE INVALID OR UNENFORCEABLE OR
THAT THE USE OF THE LICENSED PATENT RIGHTS OR LICENSED TECHNOLOGY AS
CONTEMPLATED BY THIS AGREEMENT INFRINGES THE PATENT RIGHTS OF SUCH THIRD PARTY.

 

12.                               INDEMNIFICATION

 

12.1                           INDEMNIFICATION OF DS BY ARQULE.  ARQULE SHALL
INDEMNIFY, DEFEND AND HOLD HARMLESS DS, ITS AFFILIATES, THEIR RESPECTIVE
DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS, AND THEIR RESPECTIVE SUCCESSORS,
HEIRS AND ASSIGNS (COLLECTIVELY, THE “DS INDEMNITEES”), AGAINST ALL LIABILITIES,
DAMAGES, LOSSES AND EXPENSES (INCLUDING, WITHOUT LIMITATION, REASONABLE
ATTORNEYS’ FEES AND EXPENSES OF LITIGATION) (COLLECTIVELY, “LOSSES”) INCURRED BY
OR IMPOSED UPON THE DS INDEMNITEES, OR ANY ONE OF THEM, AS A DIRECT RESULT OF
CLAIMS, SUITS, ACTIONS, DEMANDS OR JUDGMENTS OF THIRD PARTIES, INCLUDING WITHOUT
LIMITATION PERSONAL INJURY AND PRODUCT LIABILITY CLAIMS (COLLECTIVELY,
“CLAIMS”), ARISING OUT OF (A) ARQULE’S RESEARCH AND DEVELOPMENT ACTIVITIES UNDER
THIS AGREEMENT, (B) THE CO-COMMERCIALIZATION OF ANY CO-COMMERCIALIZED LICENSED
PRODUCT BY ARQULE AND (C) THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY
WAIVED COMPOUND OR TERMINATED COMPOUND BY ARQULE OR ANY OF ITS AFFILIATES,
SUBLICENSEES, DISTRIBUTORS OR AGENTS, EXCEPT WITH RESPECT TO ANY CLAIM OR LOSSES
THAT RESULT FROM A BREACH OF THIS AGREEMENT BY, OR THE GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT OF, DS; PROVIDED, THAT, WITH RESPECT TO ANY CLAIM FOR WHICH
ARQULE HAS AN OBLIGATION TO ANY DS INDEMNITEE PURSUANT TO THIS SECTION 12.1 AND
DS HAS AN OBLIGATION TO ANY ARQULE INDEMNITEE PURSUANT TO SECTION 12.2, EACH
PARTY SHALL INDEMNIFY EACH OF THE OTHER PARTY’S INDEMNITEES FOR ITS LOSSES TO
THE EXTENT OF ITS RESPONSIBILITY, RELATIVE TO THE OTHER PARTY, FOR THE FACTS
UNDERLYING THE CLAIM.

 

12.2                           INDEMNIFICATION OF ARQULE BY DS.  DS SHALL
INDEMNIFY, DEFEND AND HOLD HARMLESS ARQULE, ITS AFFILIATES, THEIR RESPECTIVE
DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS, AND THEIR RESPECTIVE SUCCESSORS,
HEIRS AND ASSIGNS (THE “ARQULE INDEMNITEES”), AGAINST ANY LOSSES INCURRED BY OR
IMPOSED UPON THE ARQULE INDEMNITEES, OR ANY ONE OF THEM, AS A DIRECT RESULT OF
CLAIMS ARISING OUT OF (A) DS’S RESEARCH ACTIVITIES UNDER THIS AGREEMENT, (B) THE
DEVELOPMENT OF ANY LICENSED PRODUCT OR THE COMMERCIALIZATION (INCLUDING, WITHOUT
LIMITATION, THE PRODUCTION, MANUFACTURE, PROMOTION, IMPORT, SALE OR USE BY ANY
PERSON) OF ANY LICENSED PRODUCT BY DS OR ANY OF ITS AFFILIATES, SUBLICENSEES,
DISTRIBUTORS OR AGENTS, AND (C) THE CO-COMMERCIALIZATION OF

 

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ANY CO-COMMERCIALIZED LICENSED PRODUCT BY DS OR ANY OF ITS AFFILIATES,
SUBLICENSEES, DISTRIBUTORS OR AGENTS, EXCEPT WITH RESPECT TO ANY CLAIM THAT
RESULTS FROM A BREACH OF THIS AGREEMENT BY, OR THE GROSS NEGLIGENCE OR WILLFUL
MISCONDUCT OF, ARQULE; PROVIDED, THAT, WITH RESPECT TO ANY CLAIM FOR WHICH
ARQULE HAS AN OBLIGATION TO ANY DS INDEMNITEE PURSUANT TO SECTION 12.1 AND DS
HAS AN OBLIGATION TO ANY ARQULE INDEMNITEE PURSUANT TO THIS SECTION 12.2, EACH
PARTY SHALL INDEMNIFY EACH OF THE OTHER PARTY’S INDEMNITEES FOR ITS LOSSES TO
THE EXTENT OF ITS RESPONSIBILITY, RELATIVE TO THE OTHER PARTY, FOR THE FACTS
UNDERLYING THE CLAIM.

 

12.3                           CONDITIONS TO INDEMNIFICATION.  A PERSON SEEKING
RECOVERY UNDER THIS ARTICLE 12 (THE “INDEMNIFIED PARTY”) IN RESPECT OF A CLAIM
SHALL GIVE PROMPT NOTICE OF SUCH CLAIM TO THE PARTY FROM WHICH RECOVERY IS
SOUGHT (THE “INDEMNIFYING PARTY”) AND, PROVIDED THAT THE INDEMNIFYING PARTY IS
NOT CONTESTING ITS OBLIGATION UNDER THIS ARTICLE 12, SHALL PERMIT THE
INDEMNIFYING PARTY TO CONTROL ANY LITIGATION RELATING TO SUCH CLAIM AND THE
DISPOSITION OF SUCH CLAIM; PROVIDED, THAT, THE INDEMNIFYING PARTY SHALL (A) ACT
REASONABLY AND IN GOOD FAITH WITH RESPECT TO ALL MATTERS RELATING TO THE
SETTLEMENT OR DISPOSITION OF SUCH CLAIM AS THE SETTLEMENT OR DISPOSITION RELATES
TO SUCH INDEMNIFIED PARTY AND (B) NOT SETTLE OR OTHERWISE RESOLVE SUCH CLAIM
WITHOUT THE PRIOR WRITTEN CONSENT OF SUCH INDEMNIFIED PARTY (WHICH CONSENT SHALL
NOT BE UNREASONABLY WITHHELD, CONDITIONED OR DELAYED).  EACH INDEMNIFIED PARTY
SHALL COOPERATE WITH THE INDEMNIFYING PARTY IN ITS DEFENSE OF ANY SUCH CLAIM IN
ALL REASONABLE RESPECTS AND SHALL HAVE THE RIGHT TO BE PRESENT IN PERSON OR
THROUGH COUNSEL AT ALL LEGAL PROCEEDINGS WITH RESPECT TO SUCH CLAIM.

 

12.4                           WARRANTY DISCLAIMER.  EXCEPT AS OTHERWISE
EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH
RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF
THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, VALIDITY AND NONINFRINGEMENT.

 

12.5                           NO WARRANTY OF SUCCESS.  NOTHING CONTAINED IN
THIS AGREEMENT SHALL BE CONSTRUED AS A WARRANTY ON THE PART OF EITHER PARTY THAT
(A) THE RESEARCH PROGRAM WILL YIELD ANY

 

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COLLABORATION COMPOUND, HIT, PRIMARY DEVELOPMENT COMPOUND, BACKUP COMPOUND OR
LICENSED PRODUCT OR OTHERWISE BE SUCCESSFUL, (B) ANY DEVELOPMENT PROGRAM WILL
YIELD A LICENSED PRODUCT OR OTHERWISE BE SUCCESSFUL OR (C) THE OUTCOME OF THE
RESEARCH PROGRAM OR ANY DEVELOPMENT PROGRAM WILL BE COMMERCIALLY EXPLOITABLE IN
ANY RESPECT.

 

12.6                           LIMITED LIABILITY.  NOTWITHSTANDING ANYTHING TO
THE CONTRARY IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
OR ANY OF ITS AFFILIATES FOR (I) ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST PROFITS OR LOST
REVENUES, OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR
SERVICES, WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR
OTHER LEGAL OR EQUITABLE THEORY.

 

13.                               MISCELLANEOUS

 

13.1                           ARBITRATION.

 

13.1.1                           FULL ARBITRATION.  ANY DISPUTE, CONTROVERSY OR
CLAIM ARISING BETWEEN THE PARTIES WITH RESPECT TO THIS AGREEMENT, INCLUDING ANY
DISPUTE, CONTROVERSY OR CLAIM RELATING TO ANY UNANIMOUS DECISION (EACH, A
“DISPUTE”), SHALL BE RESOLVED BY BINDING ARBITRATION BEFORE A PANEL OF THREE
(3) ARBITRATORS IN ACCORDANCE WITH THE RULES OF THE AAA IN EFFECT AT THE TIME
THE PROCEEDING IS INITIATED; PROVIDED, THAT, ANY DISPUTE AS TO A UNANIMOUS
DECISION SHALL BE RESOLVED PURSUANT TO SECTION 13.1.2.  IN ANY SUCH ARBITRATION,
THE FOLLOWING PROCEDURES SHALL APPLY:

 

(A)                                  THE PANEL WILL BE COMPRISED OF ONE
ARBITRATOR CHOSEN BY DS, ONE BY ARQULE AND THE THIRD BY THE TWO SO CHOSEN.  IF
EITHER, OR BOTH, OF DS OR ARQULE FAILS TO CHOOSE AN ARBITRATOR OR ARBITRATORS
WITHIN THIRTY (30) DAYS AFTER RECEIVING NOTICE OF COMMENCEMENT OF ARBITRATION OR
IF THE TWO ARBITRATORS FAIL TO CHOOSE A THIRD ARBITRATOR WITHIN THIRTY (30) DAYS
AFTER THEIR APPOINTMENT, THEN EITHER OR BOTH PARTIES SHALL IMMEDIATELY REQUEST
THAT THE ICC SELECT THE REMAINING NUMBER OF ARBITRATORS TO BE SELECTED, WHICH
ARBITRATOR(S) SHALL HAVE THE REQUISITE SCIENTIFIC BACKGROUND, EXPERIENCE AND
EXPERTISE.  THE PLACE OF ARBITRATION SHALL BE BOSTON, MASSACHUSETTS.

 

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(B)                                 EITHER PARTY MAY APPLY TO THE ARBITRATORS
FOR INTERIM INJUNCTIVE RELIEF UNTIL THE ARBITRATION DECISION IS RENDERED OR THE
DISPUTE IS OTHERWISE RESOLVED.  EITHER PARTY ALSO MAY, WITHOUT WAIVING ANY RIGHT
OR REMEDY UNDER THIS AGREEMENT, SEEK FROM ANY COURT HAVING JURISDICTION ANY
INJUNCTIVE OR PROVISIONAL RELIEF NECESSARY TO PROTECT THE RIGHTS OR PROPERTY OF
THAT PARTY PENDING RESOLUTION OF THE DISPUTE PURSUANT TO THIS SECTION 13.1.1. 
THE ARBITRATORS SHALL HAVE NO AUTHORITY TO AWARD PUNITIVE OR ANY OTHER TYPE OF
DAMAGES NOT MEASURED BY A PARTY’S COMPENSATORY DAMAGES.  EACH PARTY SHALL BEAR
ITS OWN COSTS AND EXPENSES AND ATTORNEYS’ FEES IN CONNECTION WITH ANY SUCH
ARBITRATION; PROVIDED, THAT, THE NON-PREVAILING PARTY SHALL PAY THE COSTS AND
EXPENSES INCURRED BY THE PREVAILING PARTY IN CONNECTION WITH ANY SUCH
ARBITRATION, INCLUDING REASONABLE ATTORNEYS’ FEES AND COSTS.  THE PARTIES
ACKNOWLEDGE THAT WHILE SECTION 13.4 SHALL APPLY TO ANY SUCH DISPUTE, IT IS THE
INTENTION OF THE PARTIES NOT TO USE THE DISCOVERY RULES OF THE COMMONWEALTH OF
MASSACHUSETTS IN CONNECTION WITH ANY SUCH DISPUTE.

 

(C)                                  EXCEPT TO THE EXTENT NECESSARY TO CONFIRM
AN AWARD OR DECISION OR AS MAY BE REQUIRED BY APPLICABLE LAWS, NEITHER PARTY NOR
ANY ARBITRATOR MAY DISCLOSE THE EXISTENCE OR RESULTS OF ANY ARBITRATION WITHOUT
THE PRIOR WRITTEN CONSENT OF BOTH PARTIES.  IN NO EVENT SHALL ANY ARBITRATION BE
INITIATED AFTER THE DATE WHEN COMMENCEMENT OF A LEGAL OR EQUITABLE PROCEEDING
BASED ON THE DISPUTE WOULD BE BARRED BY THE APPLICABLE MASSACHUSETTS STATUTE OF
LIMITATIONS.

 

(D)                                 IN THE EVENT OF A DISPUTE INVOLVING THE
ALLEGED BREACH OF THIS AGREEMENT (INCLUDING, WITHOUT LIMITATION, WHETHER A PARTY
HAS SATISFIED ITS DILIGENCE OBLIGATIONS HEREUNDER), (I) NEITHER PARTY MAY
TERMINATE THIS AGREEMENT UNDER SECTION 10.2.2 UNTIL RESOLUTION OF THE DISPUTE
PURSUANT TO THIS SECTION 13.1.1 AND (II) IF THE ARBITRATORS RENDER A DECISION
THAT A BREACH OF THIS AGREEMENT HAS OCCURRED, THE ARBITRATORS SHALL HAVE NO
AUTHORITY TO MODIFY THE RIGHT OF THE NON-BREACHING PARTY TO TERMINATE THIS
AGREEMENT IN ACCORDANCE WITH SECTION 10.2.2.

 

(E)                                  ANY DISPUTED PERFORMANCE OR SUSPENDED
PERFORMANCE PENDING THE RESOLUTION OF A DISPUTE THAT THE ARBITRATORS DETERMINE
TO BE REQUIRED TO BE PERFORMED BY A PARTY SHALL BE COMPLETED WITHIN A REASONABLE
TIME PERIOD FOLLOWING THE FINAL DECISION OF THE ARBITRATORS.

 

(F)                                    THE DECISION OF THE ARBITRATORS SHALL BE
THE SOLE, EXCLUSIVE AND BINDING REMEDY BETWEEN THE PARTIES REGARDING THE
DETERMINATION OF ALL DISPUTES PRESENTED.  ANY

 

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MONETARY PAYMENT TO BE MADE BY A PARTY PURSUANT TO A DECISION OF THE ARBITRATORS
SHALL BE MADE IN UNITED STATES DOLLARS, FREE OF ANY TAX OR OTHER DEDUCTION.

 

13.1.2                           ACCELERATED ARBITRATION.  TO THE EXTENT A
DISPUTE SUBMITTED TO ARBITRATION BY A PARTY UNDER SECTION 13.1.1 IS CLAIMED, BY
EITHER PARTY, TO INVOLVE A UNANIMOUS DECISION, THE FOLLOWING PROCEDURES SHALL
APPLY:

 

(A)                                  THE PARTIES SHALL MUTUALLY SELECT A SINGLE
INDEPENDENT, CONFLICT-FREE ARBITRATOR (THE “EXPERT”), WHO SHALL HAVE SUFFICIENT
SCIENTIFIC BACKGROUND AND EXPERIENCE TO RESOLVE THE DISPUTE.  IF THE PARTIES ARE
UNABLE TO REACH AGREEMENT ON THE SELECTION OF AN EXPERT WITHIN FIFTEEN (15)
BUSINESS DAYS AFTER SUBMISSION TO ARBITRATION, THEN EITHER OR BOTH PARTIES SHALL
IMMEDIATELY REQUEST THAT THE AAA SELECT AN ARBITRATOR WITH THE REQUISITE
SCIENTIFIC BACKGROUND, EXPERIENCE AND EXPERTISE.  THE PLACE OF ARBITRATION SHALL
BE BOSTON, MASSACHUSETTS.

 

(B)                                 EACH PARTY SHALL PREPARE AND SUBMIT A
WRITTEN SUMMARY OF SUCH PARTY’S POSITION AND ANY RELEVANT EVIDENCE IN SUPPORT
THEREOF TO THE EXPERT WITHIN THIRTY (30) DAYS OF THE SELECTION OF THE EXPERT. 
UPON RECEIPT OF SUCH SUMMARIES FROM EACH PARTY, THE EXPERT SHALL PROVIDE COPIES
OF THE SAME TO THE OTHER PARTY.  WITHIN THIRTY (30) DAYS OF THE DELIVERY OF SUCH
SUMMARIES BY THE EXPERT, EACH PARTY SHALL SUBMIT A WRITTEN REBUTTAL OF THE OTHER
PARTY’S SUMMARY AND MAY ALSO AMEND AND RE-SUBMIT ITS ORIGINAL SUMMARY.  ORAL
PRESENTATIONS SHALL NOT BE PERMITTED UNLESS OTHERWISE REQUESTED BY THE EXPERT. 
THE EXPERT SHALL MAKE A FINAL DECISION WITH RESPECT TO THE DISPUTE WITHIN THIRTY
(30) DAYS FOLLOWING RECEIPT OF THE LAST OF SUCH REBUTTAL STATEMENTS SUBMITTED BY
THE PARTIES.  EACH PARTY SHALL BEAR ITS OWN COSTS AND EXPENSES AND ATTORNEYS’
FEES, AND THE PARTY THAT DOES NOT PREVAIL IN THE ARBITRATION PROCEEDING SHALL
PAY THE EXPERT’S FEES AND ANY ADMINISTRATIVE FEES OF ARBITRATION.

 

13.2                           NOTICES.  ALL NOTICES AND COMMUNICATIONS SHALL BE
IN WRITING AND DELIVERED PERSONALLY OR BY COURIER OR MAILED VIA CERTIFIED MAIL,
RETURN RECEIPT REQUESTED, ADDRESSED AS FOLLOWS, OR TO SUCH OTHER ADDRESS AS MAY
BE DESIGNATED FROM TIME TO TIME:

 

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If to DS:

 

If to ARQULE:

 

 

 

Daiichi Sankyo Co., Ltd.

 

ArQule, Inc.

1-2-58, Hiromachi, Shinagawa -ku

 

19 Presidential Way

Tokyo 140-8710, Japan

 

Woburn, MA 01801

Tel: +81-3-3492-3131

 

Tel: (781) 994-0300

Fax: +81-3-5436-8561

 

Fax: (781) 376-6019

Attention:   Vice President,

 

Attention: General Counsel

                   R&D Planning

 

 

 

 

Attention   Vice President,

 

 

                  Business Development

 

 

 

 

 

With a copy to:

 

 

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 

 

One Financial Center

 

 

Boston, Massachusetts 02111

 

 

Attention: Jeffrey Wiesen, Esq.

 

 

Tel: (617) 542-6000

 

 

Fax: (617) 542-2241

 

In addition, all notices to the JEC, JRC, or USCC shall be sent to each Party’s
designees at such Party’s address stated above or to such other address as such
Party may designate by written notice given in accordance with this
Section 13.2.

 

Except as otherwise expressly provided in this Agreement or mutually agreed in
writing, any notice, communication or document (excluding payment) required to
be given or made shall be deemed given or made and effective upon actual receipt
or, if earlier, (a) three (3) business days after deposit with an
internationally-recognized overnight express courier with charges prepaid, or
(b) five (5) business days after mailed by certified, registered or regular
mail, postage prepaid, in each case addressed to a Parties at its address stated
above or to such other address as such Party may designate by written notice
given in accordance with this Section 13.2.

 

13.3                           GOVERNING LAW.  THIS AGREEMENT SHALL BE GOVERNED
BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE COMMONWEALTH OF
MASSACHUSETTS, WITHOUT REGARD TO THE APPLICATION OF PRINCIPLES OF CONFLICTS OF
LAW.

 

13.4                           BINDING EFFECT.  THIS AGREEMENT SHALL BE BINDING
UPON AND INURE TO THE BENEFIT OF THE PARTIES AND THEIR RESPECTIVE LEGAL
REPRESENTATIVES, SUCCESSORS AND PERMITTED ASSIGNS.

 

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13.5                           HEADINGS.  SECTION AND SUBSECTION HEADINGS ARE
INSERTED FOR CONVENIENCE OF REFERENCE ONLY AND DO NOT FORM A PART OF THIS
AGREEMENT.

 

13.6                           COUNTERPARTS.  THIS AGREEMENT MAY BE EXECUTED
SIMULTANEOUSLY IN TWO OR MORE COUNTERPARTS, EACH OF WHICH SHALL BE DEEMED AN
ORIGINAL AND BOTH OF WHICH, TOGETHER, SHALL CONSTITUTE A SINGLE AGREEMENT.

 

13.7                           AMENDMENT; WAIVER.  THIS AGREEMENT MAY BE
AMENDED, MODIFIED, SUPERSEDED OR CANCELED, AND ANY OF THE TERMS OF THIS
AGREEMENT MAY BE WAIVED, ONLY BY A WRITTEN INSTRUMENT EXECUTED BY EACH PARTY OR,
IN THE CASE OF WAIVER, BY THE PARTY OR PARTIES WAIVING COMPLIANCE.  THE DELAY OR
FAILURE OF EITHER PARTY AT ANY TIME OR TIMES TO REQUIRE PERFORMANCE OF ANY
PROVISIONS SHALL IN NO MANNER AFFECT THE RIGHTS AT A LATER TIME TO ENFORCE THE
SAME.  NO WAIVER BY EITHER PARTY OF ANY CONDITION OR OF THE BREACH OF ANY TERM
CONTAINED IN THIS AGREEMENT, WHETHER BY CONDUCT, OR OTHERWISE, IN ANY ONE OR
MORE INSTANCES, SHALL BE DEEMED TO BE, OR CONSIDERED AS, A FURTHER OR CONTINUING
WAIVER OF ANY SUCH CONDITION OR OF THE BREACH OF SUCH TERM OR ANY OTHER TERM OF
THIS AGREEMENT.

 

13.8                           NO THIRD PARTY BENEFICIARIES.  EXCEPT AS SET
FORTH IN SECTIONS 12.1, 12.2 AND 12.3, NO THIRD PARTY (INCLUDING, WITHOUT
LIMITATION, EMPLOYEES OF EITHER PARTY) SHALL HAVE OR ACQUIRE ANY RIGHTS BY
REASON OF THIS AGREEMENT.

 

13.9                           PURPOSES AND SCOPE.  THE PARTIES HERETO
UNDERSTAND AND AGREE THAT THIS COLLABORATION IS LIMITED TO THE ACTIVITIES,
RIGHTS AND OBLIGATIONS AS SET FORTH IN THIS AGREEMENT.  NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED (A) TO CREATE OR IMPLY A GENERAL PARTNERSHIP
BETWEEN THE PARTIES, (B) TO MAKE EITHER PARTY THE AGENT OF THE OTHER FOR ANY
PURPOSE, (C) TO ALTER, AMEND, SUPERSEDE OR VITIATE ANY OTHER ARRANGEMENTS
BETWEEN THE PARTIES WITH RESPECT TO ANY SUBJECT MATTERS NOT COVERED HEREUNDER,
(D) TO GIVE EITHER PARTY THE RIGHT TO BIND THE OTHER, (E) TO CREATE ANY DUTIES
OR OBLIGATIONS BETWEEN THE PARTIES EXCEPT AS EXPRESSLY SET FORTH HEREIN, OR
(F) TO GRANT ANY DIRECT OR IMPLIED LICENSES OR ANY OTHER RIGHT OTHER THAN AS
EXPRESSLY SET FORTH HEREIN.

 

13.10                     ASSIGNMENT AND SUCCESSORS.  NEITHER THIS AGREEMENT NOR
ANY OBLIGATION OF A PARTY HEREUNDER MAY BE ASSIGNED BY EITHER PARTY WITHOUT THE
CONSENT OF THE OTHER WHICH SHALL NOT BE UNREASONABLY WITHHELD, EXCEPT THAT EACH
PARTY MAY ASSIGN THIS AGREEMENT AND THE RIGHTS,

 

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OBLIGATIONS AND INTERESTS OF SUCH PARTY, IN WHOLE OR IN PART, TO ANY OF ITS
AFFILIATES, TO ANY PURCHASER OF ALL OR SUBSTANTIALLY ALL OF ITS ASSETS OR ALL OR
SUBSTANTIALLY ALL OF ITS ASSETS TO WHICH THIS AGREEMENT RELATES OR TO ANY
SUCCESSOR CORPORATION RESULTING FROM ANY MERGER, CONSOLIDATION, SHARE EXCHANGE
OR OTHER SIMILAR TRANSACTION.

 

13.11                     FORCE MAJEURE.  NEITHER DS NOR ARQULE SHALL BE LIABLE
FOR FAILURE OF OR DELAY IN PERFORMING OBLIGATIONS SET FORTH IN THIS AGREEMENT,
AND NEITHER SHALL BE DEEMED IN BREACH OF ITS OBLIGATIONS, IF SUCH FAILURE OR
DELAY IS DUE TO A FORCE MAJEURE.  IN EVENT OF SUCH FORCE MAJEURE, THE PARTY
AFFECTED SHALL USE REASONABLE EFFORTS TO CURE OR OVERCOME THE SAME AND RESUME
PERFORMANCE OF ITS OBLIGATIONS HEREUNDER.

 

13.12                     INTERPRETATION.  THE PARTIES HERETO ACKNOWLEDGE AND
AGREE THAT: (A) EACH PARTY AND ITS COUNSEL REVIEWED AND NEGOTIATED THE TERMS AND
PROVISIONS OF THIS AGREEMENT AND HAVE CONTRIBUTED TO ITS REVISION; (B) THE
RULE OF CONSTRUCTION TO THE EFFECT THAT ANY AMBIGUITIES ARE RESOLVED AGAINST THE
DRAFTING PARTY SHALL NOT BE EMPLOYED IN THE INTERPRETATION OF THIS AGREEMENT;
AND (C) THE TERMS AND PROVISIONS OF THIS AGREEMENT SHALL BE CONSTRUED FAIRLY AS
TO EACH PARTY AND NOT IN A FAVOR OF OR AGAINST EITHER PARTY, REGARDLESS OF WHICH
PARTY WAS GENERALLY RESPONSIBLE FOR THE PREPARATION OF THIS AGREEMENT.

 

13.13                     INTEGRATION; SEVERABILITY.  THIS AGREEMENT IS THE
ENTIRE AGREEMENT WITH RESPECT TO THE SUBJECT MATTER HEREOF AND SUPERSEDES ALL
OTHER AGREEMENTS AND UNDERSTANDINGS BETWEEN THE PARTIES WITH RESPECT TO SUCH
SUBJECT MATTER.  NOTWITHSTANDING THE FOREGOING, THIS AGREEMENT SHALL NOT
SUPERSEDE THE CONFIDENTIALITY DISCLOSURE AGREEMENT DATED FEBRUARY 24, 2008 (THE
“PRIOR CDA”) BETWEEN ARQULE AND DS, WHICH SHALL CONTINUE TO BE IN FULL FORCE AND
EFFECT IN ACCORDANCE WITH ITS TERMS AND CONDITIONS.  ALL DISCLOSURES AND
INFORMATION FROM ARQULE TO DS PRIOR TO THE EFFECTIVE DATE SHALL BE GOVERNED BY
THE PRIOR CDA, AND ALL DISCLOSURES AND INFORMATION FROM ARQULE TO DS AFTER THE
EFFECTIVE DATE SHALL BE GOVERNED BY THIS AGREEMENT.  IF ANY PROVISION OF THIS
AGREEMENT IS OR BECOMES INVALID OR IS RULED INVALID BY ANY COURT OF COMPETENT
JURISDICTION OR IS DEEMED UNENFORCEABLE, IT IS THE INTENTION OF THE PARTIES THAT
THE REMAINDER OF THE AGREEMENT SHALL NOT BE AFFECTED.

 

13.14                     FURTHER ASSURANCES.  EACH OF ARQULE AND DS AGREES TO
DULY EXECUTE AND DELIVER, OR CAUSE TO BE DULY EXECUTED AND DELIVERED, SUCH
FURTHER INSTRUMENTS AND DO AND CAUSE TO

 

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BE DONE SUCH FURTHER ACTS AND THINGS, INCLUDING, WITHOUT LIMITATION, THE FILING
OF SUCH ADDITIONAL ASSIGNMENTS, AGREEMENTS, DOCUMENTS AND INSTRUMENTS, AS THE
OTHER PARTY MAY AT ANY TIME AND FROM TIME TO TIME REASONABLY REQUEST IN
CONNECTION WITH THIS AGREEMENT OR TO CARRY OUT MORE EFFECTIVELY THE PROVISIONS
AND PURPOSES OF, OR TO BETTER ASSURE AND CONFER UNTO SUCH OTHER PARTY ITS RIGHTS
AND REMEDIES UNDER, THIS AGREEMENT.

 

[Remainder of page intentionally left blank.]

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

 

ARQULE, INC.

 

 

 

 

By:

/s/ Paolo Pucci

 

 

 

 

Name: Paolo Pucci

 

 

 

 

Title: Chief Executive Officer

 

 

 

 

 

 

 

DAIICHI SANKYO CO., LTD.

 

 

 

 

By:

/s/ Kazuhiro Hirokawa

 

 

 

 

Name: Kazuhiro Hirokawa

 

 

 

 

Title: Executive Officer,

 

          Head of R&D Division

 

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SCHEDULE 1

 

RESEARCH STAGES/ADVANCEMENT CRITERIA

 

Research Stage:  *

 

Activities:

 

·                  *

 

·                  *

 

·                  *

 

·                  *

 

Advancement Criteria:

 

·                  *

 

Research Stage:  Hit to Lead Activities

 

Activities:

 

·                  *

 

·                  *

 

·                  *

 

·                  *

 

Advancement Criteria:

 

·                  *

 

·                  *

 

·                  *

 

1-1

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Research Stage:  Lead Optimization

 

Activities:

 

·                  *

 

·                  *

 

·                  *

 

Advancement Criteria:

 

·                  *

 

·                  *

 

·                  *

 

·                  *

 

·                  *

 

Research Stage:  *

 

Activities:

 

·                  *

 

·                  *

 

Advancement Criteria:

 

·                  *

 

1-2

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SCHEDULE 2

 

DS TARGET LIST

 

*

 

*

 

2-1

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SCHEDULE 3

 

MILESTONE AND ROYALTY PROVISIONS TO BE NEGOTIATED PURSUANT TO SECTION 5.4 AND

 

INCLUDED IN LICENSE AGREEMENTS

 

1.                                       Milestones.

 

(a)                                  Clinical Development & Sales Milestones. 
Within * (*) days after the occurrence of the following milestone events, DS
shall make non-refundable, non-creditable (except as provided below) milestone
payments for events and in amounts to be agreed pursuant to Section 5.4 of the
Agreement to ARQULE for each Licensed Product that is Developed and
Commercialized under a License Agreement:

 

Milestone Event

 

Milestone Payment

 

 

 

*

 

Number of indications and corresponding payments to be determined

 

 

 

*

 

Number of indications and corresponding payments to be determined

 

 

 

*

 

Number of indications and corresponding payments to be determined

 

 

 

*

 

Tiered sales brackets and corresponding milestone payments to be determined.

 

2.                                       Determination that Milestone Events
have Occurred.  DS shall provide ARQULE with written notice within ten (10) days
of each occurrence of a milestone event set forth above.  In the event that,
notwithstanding the fact that DS has not given such a notice, ARQULE believes
any such milestone event has occurred, it shall so notify DS in writing and
shall provide to DS data, documentation or other information that supports its
belief.  Any dispute under this

 

3-1

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Section that relates to whether or not a milestone event has occurred shall be
referred to the JEC to be resolved in accordance with Section 2.1.5 of the
Agreement.

 

3.                                       Crediting of Milestone Payments for
Backup Compounds.  In the event that any milestone payment is made for a
Licensed Product, the Development and/or Commercialization of such Licensed
Product is subsequently terminated and a Backup Compound with respect to such
Licensed Product is Developed and/or Commercialized in lieu of such Licensed
Product, then all such previously paid milestone payments paid with respect to
such terminated Licensed Product shall be creditable against the same milestone
payments due and payable for such Backup Compound.

 

4.                                       Payment of Royalties.

 

(a)                                  Royalty Rates.  DS shall pay ARQULE a
royalty based on Annual Net Sales of each Licensed Product in each Calendar Year
(or partial Calendar Year) commencing with the First Commercial Sale of such
Licensed Product in any country in the Territory and ending upon the last day of
the last Royalty Term for such Licensed Product at royalty rates and for tiers
of Net Sales to be agreed pursuant to Section 5.4 of the Agreement.

 

(b)                                 Royalty Rate Adjustments.  Notwithstanding
anything to the contrary in Section 4(a) of this Schedule 3, if any Licensed
Product is sold in a country and is only covered by a Valid Claim that is
included in the Joint Patent Rights, then, during the period commencing on the *
(*) anniversary of the First Commercial Sale of such Licensed Product in such
country and continuing until the last day of the applicable Royalty Term with
respect to such Licensed Product in such country, the royalty rates in such
country shall be reduced by * percent (*%) of the rates set forth above.  If the
royalty rate on a Licensed Product is reduced in a country under this
Section 4(b) and is subsequently covered by a Valid Claim under the Licensed
Patent Rights in such country, the full royalty rates otherwise applicable shall
be reinstated for so long as such Valid Claim covers the Licensed Product during
the remainder of the applicable Royalty Term.

 

(c)                                  Generic Licensed Products.  In the event
that one or more Third Parties sell a Generic Licensed Product (as defined
below) in any country in which a Licensed Product is then being sold by DS,
then, (i) during any Calendar Quarter in which sales of the Generic Licensed
Product

 

3-2

--------------------------------------------------------------------------------

 

by such Third Parties are equal to or greater than * percent (*%) but less than
* percent (*%) of aggregate unit sales of Licensed Products and Generic Licensed
Products in such country (as measured by prescriptions or other similar
information available from a Third Party Data Provider and applicable to such
country) the applicable royalties in effect with respect to such Licensed
Product in such country as specified in Section 4(a) of this Schedule 3 shall be
reduced by * percent (*%) and (ii) during any Calendar Quarter in which sales of
the Generic Licensed Products by such Third Parties are equal to or greater than
* percent (*%) of aggregate unit sales of Licensed Products and Generic Licensed
Products in such country (as measured by prescriptions or other similar
information available from a Third Party Data Provider and applicable to such
country) the applicable royalties in effect with respect to such Licensed
Product in such country as specified in Section 4(a) of this Schedule 3 shall be
reduced by * percent (*%).  Notwithstanding the foregoing, (i) DS’s obligation
to pay royalties at * percent (*%) of the applicable royalty rates shall be
reinstated on the first day of the Calendar Quarter immediately following the
Calendar Quarter in which sales of such Generic Licensed Products account for
less than * percent (*%) but more than * percent (*%) of aggregate unit sales of
Licensed Products and Generic Licensed Products in such country and (ii) DS’s
obligation to pay royalties at the full royalty rates shall be reinstated on the
first day of the Calendar Quarter immediately following the Calendar Quarter in
which sales of such Generic Licensed Products account for * percent (*%) or less
of aggregate unit sales of Licensed Products and Generic Licensed Products in
such country.  Notwithstanding the foregoing, the provisions of this
Section 4(c) shall not apply for any country in which DS has not filed for
patent protection for the applicable Licensed Product or has not otherwise used
commercially reasonable efforts to secure patent protection for such Licensed
Product.  For purposes of this Section 4(c), a “Generic Licensed Product” means
a pharmaceutical product that contains the same active ingredient as a Licensed
Product and is bioequivalent to such Licensed Product; provided, that, any
product sold by DS or any Affiliate or licensee of DS shall not be a Generic
Licensed Product for purposes of this Agreement.

 

3-3

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