elsewhere, in no event shall BVL's
liability to Customer for in-process loss of API or Customer-supplied
Composition be in excess of $**** or $****, as applicable, per Batch.
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8.6.
LIABILITY LIMITATION.
8.6.1.
ELECTION OF REMEDIES. SECTION 3.9.4, 3.9.5, 8.2, 8.5,
25.1 AND 34 ARE CUSTOMER'S SOLE AND EXCLUSIVE REMEDY FOR ANY PRODUCT THAT DOES
NOT COMPLY WITH THE SPECIFICATIONS CONTAINED IN THE MASTER BATCH RECORD AND/OR
WERE NOT MANUFACTURED IN ACCORDANCE WITH THE REQUIREMENTS SET FORTH IN THIS
AGREEMENT.
8.6.2.
SPECIAL DAMAGES. NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES, INCLUDING
WITHOUT LIMITATION, LOST PROFITS, LOST MARKET SHARE OR DAMAGES STEMMING FROM AN
INTERRUPTION OF SUPPLY ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY
THEORY OF LIABILITY (THE "SPECIAL DAMAGES").
8.6.3.
AGGREGATE CAP ON COSTS, LOSSES, EXPENSES AND DAMAGES.
THE PARTIES RECOGNIZE AND ACKNOWLEDGE THAT THIS ARTICLE 8 ATTEMPTS TO EQUITABLY
ALLOCATE RISK WITH RESPECT TO EACH PARTIES' RESPECTIVE INTEREST IN THE AGREEMENT
AND THAT THE LIMITATIONS OF LIABILITY SET FORTH HEREIN ARE COMPROMISES.
NOTWITHSTANDING ANYTHING TO THE CONTRARY SET FORTH HEREIN. A PARTY'S TOTAL
MAXIMUM AGGREGATE LIABILITY FOR COSTS, LOSSES, EXPENSES, DAMAGES, LIABILITY AND
INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT SHALL NOT EXCEED **** DOLLARS
($****) (THE "BVL CAP").
THE BVL CAP ON DAMAGES AND LIABILITY IS INTEGRAL TO
THIS AGREEMENT AND THE AGREEMENT WOULD NOT HAVE BEEN EXECUTED IN ITS ABSENCE.
8.6.4.
EXCEPTIONS TO LIABILITY CAP.
THE BVL CAP SHALL NOT
APPLY TO DAMAGES RESULTING FROM: BREACHES BY A PARTY OF A DUTY IMPOSED UNDER
ARTICLE 9 (CONFIDENTIALITY), ARTICLE 11 (INTELLECTUAL PROPERTY), OR DUE TO A
PARTY'S WILLFUL MISCONDUCT OR FRAUD.
FOR THE AVOIDANCE OF DOUBT, THE PARTIES
EXPLICITLY ACKNOWLEDGE AND AGREE THAT BVL'S OFFERING TO ENTER INTO THIS
AGREEMENT AND ENTERING INTO THIS AGREEMENT GIVEN BVL'S CURRENT AND POTENTIAL
REGULATORY SITUATION AND THE POTENTIAL IMPACT OF THAT ON BVL'S ABILITY TO
MANUFACTURE AND DELIVER PRODUCT UNDER THIS AGREEMENT SHALL NOT SERVE AS THE
BASIS OF ANY CLAIM FOR WILLFUL MISCONDUCT, FRAUD OR FRAUD IN THE INDUCEMENT.
8.6.5.
INTEGRAL PROVISIONS.
THE LIMITATIONS SET FORTH IN THIS
SECTION 8.6 SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY
LIMITED REMEDY. SUCH LIMITED WARRANTIES, LIMITATION OF LIABILITY AND SPECIAL
PROVISIONS ARE INTEGRAL PARTS OF THIS AGREEMENT.
ARTICLE 9 -
CONFIDENTIALITY
9.1.
Confidential Information. As used in this
Agreement, "Confidential Information" means any scientific, technical, trade,
business or proprietary information related to the subject of the Agreement,
irrespective of whether in human or machine-readable form, tangible or
25
intangible, (a) which is or has been given by the Disclosing Party to the
Receiving Party or otherwise acquired or perceived by the Receiving Party from
the Disclosing Party; or (b) which was developed by BVL for Customer under the
terms of the Manufacturing Agreement, Transition Services agreement or is
developed by BVL for Customer under the terms of this Agreement.
Confidential
Information does not include information that: (a) is lawfully in the possession
of the Receiving Party, without restriction