ANY PORTION OF THE CHIRON DEVELOPMENT PLAN OR DISCONTINUE ANY SUCH
PRECLINICAL STUDIES OR CLINICAL TRIALS, IN RESPONSE TO (I) CHANGES IN CLINICAL
OR REGULATORY STRATEGY OF EITHER CHIRON OR CUBIST, (II) REGULATORY FEEDBACK,
(III) SCIENTIFIC FEASIBILITY, (IV) INCREASES IN THE ANTICIPATED COSTS OF
CLINICAL TRIALS, (V) ANY SIGNIFICANT ADVERSE EVENT OR CONDITION RELATING TO THE
SAFETY OR EFFICACY OF A LICENSED PRODUCT, (VI) MANUFACTURING FEASIBILITY,
INCLUDING, WITHOUT LIMITATION, CHANGES IN THE ANTICIPATED COSTS OF MANUFACTURING
AND/OR PROCURING LICENSED PRODUCT, (VII) SIGNIFICANT ADVERSE CHANGES IN MARKET
CONDITIONS OR IN MARKET POTENTIAL OF A DRUG CANDIDATE, OR (VIII) ANY OTHER
REASON THAT CHIRON DETERMINES IN ITS REASONABLE DISCRETION JUSTIFIES SUCH
CHANGE, MODIFICATION, ABANDONMENT OR DISCONTINUATION; HOWEVER, PRIOR TO MAKING
ANY DECISION TO ABANDON ANY DEVELOPMENT EFFORT (OR CHANGE OR MODIFY ANY SUCH
EFFORT SO AS TO EFFECTIVELY ABANDON SAME), CHIRON SHALL HAVE FIRST PROVIDED ITS
REASONS IN SUPPORT OF SUCH DECISION TO CUBIST VIA THE JCT AND THE JCT SHALL HAVE
MET TO DISCUSS THE MERITS OF SUCH DECISION. THE EXERCISE BY CHIRON OF ANY RIGHT
THAT IT MAY HAVE UNDER THIS SECTION 4.3(D) TO CHANGE, MODIFY, ABANDON OR
DISCONTINUE ALL OR ANY PORTION OF THE CHIRON DEVELOPMENT PLAN OR ANY OF THE
PRECLINICAL STUDIES OR CLINICAL TRIALS DESCRIBED IN THE CHIRON DEVELOPMENT PLAN
SHALL NOT RELIEVE CHIRON FROM ITS OBLIGATIONS TO USE COMMERCIALLY REASONABLE
EFFORTS UNDER SECTION 5.1 OR SECTION 6.1 HEREOF.
(E)
LIMITATION ON CHIRON'S DEVELOPMENT RIGHTS.
NOTWITHSTANDING ANYTHING IN
THIS SECTION 4.3 TO THE CONTRARY, IN THE EVENT THAT AT ANY TIME CUBIST
REASONABLY BELIEVES, ON THE BASIS OF MEDICAL, CLINICAL, SCIENTIFIC AND OTHER
DATA, FACTS AND KNOWLEDGE THAT HAVE BEEN PUBLISHED OR ARE OTHERWISE DOCUMENTED
AND AVAILABLE OR ARE KNOWN TO SUBJECT MATTER EXPERTS, AND PRESENTED TO CHIRON,
THAT ANY OF THE DEVELOPMENT ACTIVITIES BEING CONDUCTED OR TO BE CONDUCTED BY
CHIRON PURSUANT TO THIS SECTION 4.3 IS SUBSTANTIALLY LIKELY TO RESULT IN GLOBAL
HARM, CUBIST SHALL PROMPTLY CONVENE A MEETING OF THE JCT TO DISCUSS SAME.
PRIOR
TO THE MEETING, CUBIST WILL PROVIDE TO CHIRON ALL RELEVANT DOCUMENTS, MATERIALS
AND INFORMATION SUGGESTING THE LIKELIHOOD OF GLOBAL HARM AS WELL AS CUBIST'S
RECOMMENDATIONS TO CHIRON ON THE COURSE OF ACTION (E.G. MODIFY THE
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
26
study, terminate the study, etc.).
At the JCT, the Parties will discuss and
attempt to reach consensus on the course of action.
Following such discussion,
in the absence of consensus, Cubist shall have the right to require Chiron to
modify or discontinue those development activities that Cubist reasonably and in
good faith believes, based on the totality of the data, facts and knowledge
presented to Chiron and the data, facts and knowledge presented by Chiron in
response, are substantially likely to result in Global Harm.
In the event that
there is no person (including a successor-in-interest to Cubist) to carry out
Cubist's development obligations under Section 4.1, then (i) the provisions of
this Section 4.3(e) shall not be