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