a recall, withdrawal or correction, and HORIZON
and/or its designee shall have the sole responsibility for the handling and
disposition of such recall, market withdrawal or correction. In the event that a
recall is required directly due to BI's breach of any of its warranties set
forth in Section 10.2 hereof, BI shall reimburse HORIZON for the purchase price
of such DELIVERED MATERIAL and all other reasonable costs and expenses
associated with such DELIVERED MATERIAL recall, market withdrawal or correction,
but only to the extent that the foregoing costs and expenses are attributable to
BI's breach of its warranties hereunder. In all other events of a recall, all
costs and expenses incurred in connection with such PRODUCT recall shall be
borne by HORIZON, and BI shall be entitled to charge HORIZON for reasonable
costs and expenses for [BI's] support to HORIZON in handling a recall.
Notwithstanding the foregoing, if each of BI and HORIZON contribute to the cause
of a recall, the costs and expenses shall be shared in proportion to each
Party ́s responsibility, provided however that the limitation of liability
according to Section 12 shall apply. HORIZON and/or its designee shall serve as
the sole point of contact with the FDA or other applicable HEALTH AUTHORITY
concerning any recall, market withdrawal or correction with respect to the
DELIVERED MATERIAL.
9.3 Insurance
During the term of this AGREEMENT and following the term of this Agreement for
the remainder of the shelf life of all DRUG SUBSTANCE and PRODUCT supplied to
HORIZON hereunder, the Parties shall maintain product liability insurance in
such amounts and with such
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scope of coverage as are adequate to cover the Parties' obligations under this
AGREEMENT and as appropriate for companies of like size, taking into account the
scope of activities contemplated herein. Notwithstanding the foregoing the
Parties shall maintain minimum limits of product liability of [...***...] US$ per
occurrence and in the aggregate annually. The Parties shall provide to each
other within [...***...] of execution of this AGREEMENT and thereafter, once a year
upon the other Party's request, a certificate of insurance evidencing the
respective Party's product liability insurance. In addition to the foregoing
coverage, the Parties shall maintain Commercial General Liability Insurance for
limits of not less than [...***...] US$ per occurrence and in the aggregate annually
for bodily injury and property damage. Notwithstanding the foregoing, BI shall
have the right to self-insure at any time that it can demonstrate it has the
financial resources and capabilities to adequately self-insure against the
potential liabilities at levels equivalent to or greater than those set forth
above, provided that BI gives HORIZON written notice of such self-insurance. If
BI self-insures as set forth above, then it shall provide HORIZON with current
information reasonably requested by HORIZON as is necessary to verify BI's
ability to so self-insure.
10. REPRESENTATIONS AND WARRANTIES
10.1 Each Party hereby represents and warrants to the other Party that: (a) the
person