BE
IN BREACH OF THIS SECTION 4.1.1(C) FOR FAILURE TO DISCLOSE INFORMATION, IF,
DESPITE COMMERCIALLY REASONABLE EFFORTS, ARRAY CANNOT IDENTIFY SUCH
INFORMATION.
WITHOUT LIMITING THE FOREGOING, ARRAY SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO ENSURE ORDERLY TRANSITION AND UNINTERRUPTED RESEARCH AND
DEVELOPMENT OF COLLABORATION COMPOUNDS, AND IF APPLICABLE, CORRESPONDING
COLLABORATION BACK-UP COMPOUNDS, UNDER THIS SECTION 4.1.1.
(II)
IN ADDITION, THE JDC SHALL MEET AND DISCUSS HOW BEST TO TRANSITION THE
MANUFACTURE OF SUCH COLLABORATION COMPOUND AND, IF APPLICABLE, COLLABORATION
BACK-UP COMPOUNDS TO CELGENE (OR ITS DESIGNEE) AND SHALL ESTABLISH A SUPPLY
TRANSITION PLAN WITH RESPECT TO SUCH COLLABORATION COMPOUND AND COLLABORATION
BACK-UP COMPOUNDS.
ARRAY SHALL COOPERATE FULLY TO TRANSITION TO CELGENE ALL
MANUFACTURING ACTIVITIES RELATED TO THE COLLABORATION COMPOUND AND ITS
CORRESPONDING COLLABORATION BACK-UP COMPOUNDS AS REFLECTED IN THE DEVELOPMENT
PLAN AND SUPPLY TRANSITION PLAN APPROVED BY THE JDC.
CELGENE, AT ITS OPTION,
MAY PURCHASE FROM ARRAY ANY SURPLUS QUANTITIES OF GMP COLLABORATION COMPOUND AND
COLLABORATION BACK-UP COMPOUNDS [ * ].
(III)
ARRAY SHALL PROVIDE CELGENE WITH A PROPOSED BUDGET OUTLINING ANTICIPATED
COSTS INCURRED BY ARRAY, ITS AFFILIATES OR SUBCONTRACTORS IN PERFORMING THOSE
ADDITIONAL DEVELOPMENT ACTIVITIES (E.G., PRECLINICAL STUDIES AND CMC-RELATED
ACTIVITIES, INCLUDING FORMULATION AND PROCESS DEVELOPMENT, TOGETHER WITH
ASSOCIATED REGULATORY ACTIVITIES, AND IN EACH CASE RELATING
31
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
DIRECTLY TO THE DEVELOPMENT COMPOUND) NOT DIRECTLY ATTRIBUTABLE TO THE ONGOING
CONDUCT OF CLINICAL TRIALS THAT ARRAY PERFORMED IN ACCORDANCE WITH THE
DEVELOPMENT PLAN DURING THE LAST CLINICAL TRIAL OF A COLLABORATION COMPOUND OR
COLLABORATION BACK-UP COMPOUND CONDUCTED PRIOR TO CELGENE'S EXERCISE OF THE
CELGENE PRODUCT OPTION IN RESPECT OF SUCH COLLABORATION COMPOUND OR
COLLABORATION BACK-UP COMPOUND, WHICH BUDGET SHALL BE REVISED OR UPDATED FROM
TIME TO TIME, PROVIDED THAT ANY [ * ] ABOVE THE ORIGINAL BUDGET SUBMITTED BY
ARRAY SHALL [ * ].
ARRAY SHALL SUBMIT AN ITEMIZED INVOICE TO CELGENE OUTLINING
SUCH COSTS, AND, UPON REQUEST, ARRAY SHALL PROVIDE CELGENE WITH REASONABLY
DETAILED DOCUMENTATION THEREOF.
SUCH COSTS DESCRIBED IN THE PRECEDING SENTENCE
SHALL BE CALCULATED AS FOLLOWS: (A) FOR ARRAY FTES PERFORMING SUCH ACTIVITIES, [
* ]; (B) [ * ] COSTS PAID TO THIRD PARTIES FOR THE PERFORMANCE OF SUCH
ACTIVITIES [ * ]; AND (C) ARRAY'S [ * ] FOR OBTAINING OR MANUFACTURING
REASONABLE QUANTITIES OF THE DEVELOPMENT COMPOUND OR DEVELOPMENT BACK-UP
COMPOUND USED AS IN PERFORMING SUCH ACTIVITIES.
CELGENE SHALL PAY ANY INVOICE
ISSUED UNDER THIS SECTION 4.1.1(C)(III) [ * ], PROVIDED, HOWEVER, THAT CELGENE
SHALL NOT BE OBLIGATED TO PAY ANY AMOUNTS [ * ] SUBMITTED BY ARRAY IF CELGENE [
* ].
FOR THE AVOIDANCE OF DOUBT, CELGENE SHALL NOT BE OBLIGATED TO REIMBURSE
ARRAY FOR ANY SUCH COSTS WITH RESPECT TO ANY DEVELOPMENT COMPOUND OR DEVELOPMENT
BACK-UP COMPOUND ON WHICH CELGENE DOES NOT EXERCISE THE CELGENE PRODUCT OPTION.
4.1.2
TERMINATION.
IN THE EVENT THAT