EACH LICENSED PRODUCT SHALL BE PREPARED BY DS AND SUBMITTED TO THE JEC
FOR ITS REVIEW WITHIN * (*) DAYS OF THE DATE OF
39
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.)
40
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