AND UPDATING THE DEVELOPMENT PLAN FROM TIME TO TIME,
(III) MONITORING THE PROGRESS AND RESULTS OF THE DEVELOPMENT PROGRAM,
(IV) DETERMINING FUTURE DEVELOPMENT PROGRAM ACTIVITIES, INCLUDING DEVELOPMENT
ACTIVITIES RELATING TO MANUFACTURING, TO BE CONDUCTED DURING THE DEVELOPMENT
TERM, AND (V) ESTABLISHING SUCCESS CRITERIA FOR THE CLINICAL TRIALS (OTHER THAN
THOSE FOR WHICH SUCCESS CRITERIA ARE SET FORTH IN THIS AGREEMENT), AND
DETERMINING WHETHER THE RESULTS OF SUCH CLINICAL TRIALS HAVE ACHIEVED THE
APPLICABLE SUCCESS CRITERIA.
(D)
THE JDC SHALL ONLY ACT UNANIMOUSLY, WITH EACH PARTY GIVEN ONE
(1) VOTE REGARDLESS OF THE NUMBER OF REPRESENTATIVES.
IF, HOWEVER, THE JDC IS
UNABLE TO REACH AGREEMENT WITH RESPECT TO ANY MATTER WITHIN [**] DAYS, THE
MATTER SHALL BE REFERRED TO THE PARTIES' RESPECTIVE EXECUTIVE OFFICERS FOR
RESOLUTION.
IF THE EXECUTIVE OFFICERS ARE NOT ABLE TO RESOLVE ANY SUCH MATTER
BY CONSENSUS WITHIN [**] DAYS FOLLOWING REFERRAL, IKARIA'S EXECUTIVE OFFICER
SHALL HAVE THE RIGHT TO DECIDE THE MATTER TAKING INTO ACCOUNT IKARIA'S
OBLIGATION TO USE COMMERCIALLY REASONABLE EFFORTS UNDER SECTION 3.8.
Notwithstanding anything in this Section 3.2, neither Party shall have a
unilateral right to resolve any dispute involving the breach or alleged breach
of this Agreement, to amend or modify this Agreement or the Parties' respective
rights and obligations hereunder or, except as expressly provided in this
Section 3.2, any Development Plan or the Parties' respective rights and
obligations thereunder.
SECTION 3.3
ON-GOING TRIALS.
BIOLINERX SHALL RETAIN CONTROL OF, BEAR
ALL COSTS RELATING TO THE ON-GOING PHASE I/II TRIAL AND THE OTHER ON-GOING
TRIALS, AND SHALL EXERCISE COMMERCIALLY REASONABLE EFFORTS TO CONTINUE AND
COMPLETE THE ON-GOING PHASE I/II TRIAL AND THE OTHER ON-GOING TRIALS, WHICH
SHALL BE MANAGED BY BIOLINERX.
BIOLINERX MAY MODIFY THE ON-GOING PHASE I/II
TRIAL AND THE OTHER ON-GOING TRIALS, INCLUDING ANY CHANGES TO THE PROTOCOLS
THEREFOR, ONLY WITH THE PRIOR WRITTEN CONSENT OF IKARIA, WHICH CONSENT SHALL NOT
BE UNREASONABLY WITHHELD, CONDITIONED OR DELAYED.
SECTION 3.4
REGULATORY MATTERS.
IKARIA SHALL PREPARE AND SUBMIT ALL
FILINGS WITH REGULATORY AUTHORITIES RELATING TO PRODUCTS, WHICH FILINGS SHALL BE
IN IKARIA'S NAME, PROVIDED THAT IKARIA SHALL PROVIDE BIOLINERX [**] DAYS PRIOR
NOTICE TO ENABLE BIOLINERX TO REVIEW AND PROVIDE ANY COMMENTS ON SUCH
SUBMISSIONS.
WITH RESPECT TO REGULATORY MATTERS CONCERNING PRODUCTS, BIOLINERX
SHALL COOPERATE WITH IKARIA IN THE PREPARATION AND SUPPORT OF EACH APPLICATION
FOR REGULATORY APPROVAL AND SHALL PROVIDE IKARIA WITH SUCH REASONABLE ASSISTANCE
AS IKARIA MAY
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REQUEST.
FOR EXAMPLE, UPON IKARIA'S REQUEST, BIOLINERX SHALL DESCRIBE THE
MATERIALS IN SUFFICIENT AND REASONABLE DETAIL AS REQUESTED BY IKARIA, THE
MANUFACTURING TECHNIQUES AND OTHER APPROPRIATE CHARACTERISTICS OF PRODUCTS (AND
THE COMPONENTS THEREOF), AND PROVIDE IKARIA WITH SUCH OTHER INFORMATION RELATED
TO THE PRODUCTS, INCLUDING MATERIALS, CHEMISTRY, MANUFACTURING, TECHNICAL
DOSSIER AND CONTROLS DATA, BATCH RECORDS, ANALYTICAL AND QUALITY CONTROL, DEVICE
MASTER FILES (IF APPLICABLE), DATA FROM THE ON-GOING PHASE I/II TRIAL OR OTHER
ON-GOING TRIALS, OR OTHER INFORMATION AS IKARIA MAY REASONABLY REQUEST.
SECTION 3.5
TECHNOLOGY EXCHANGE.
(A)
AS SOON AS REASONABLY PRACTICABLE AFTER IKARIA'S WRITTEN REQUEST,
BIOLINERX SHALL COMPLETE THE ACTIVITIES