a buffer and/or the
off-site storage of certain PRODUCT, DRUG SUBSTANCE or materials relating
thereto.
4.10 Material Supply Breach
4.10.1 In the event of a MATERIAL SUPPLY BREACH, HORIZON shall provide BI
written notification of such MATERIAL SUPPLY BREACH.
4.10.2 Upon BI's receipt of such notice the Parties shall agree in writing upon
a timetable and activity plan to cure such MATERIAL SUPPLY BREACH as promptly as
possible (the "CURE PLAN"). If the Parties fail to agree upon such a CURE PLAN
within [...***...] from the date of notice of such MATERIAL SUPPLY BREACH, or if BI
fails to comply with such CURE PLAN, or if despite BI's compliance with the CURE
PLAN, BI cannot cure the MATERIAL SUPPLY BREACH, then HORIZON shall have the
right to purchase from a second source manufacturer, to be agreed upon within
the STEERING COMMITTEE in accordance with Section 7.4, such amounts of PRODUCT
as necessary to offset BI's shortfall in fulfilling HORIZON's purchase orders
for such PRODUCT (or the anticipated shortfall).
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4.10.3 BI shall evaluate its capabilities and, as applicable, promptly nominate
a BI AFFILIATE as a second source manufacturer and, if such BI AFFILIATE is
approved by HORIZON, shall use its commerically reasonable efforts to qualify
such BI AFFILIATE as promptly as possible. In the event that:
(i) a BI AFFILIATE can not qualify as a second source manufacturer for PRODUCT
or DRUG SUBSTANCE, as applicable, or such a BI AFFILIATE is unable to
demonstrate to HORIZON's reasonable satisfaction that it will be able to supply
HORIZON's PRODUCT or DRUG SUBSTANCE requirements, and
(ii) provided that PRODUCT or DRUG SUBSTANCE supply as requested by HORIZON by a
different second source manufacturer, a company experienced in manufacturing of
biopharmaceuticals derived from [...***...], and selected by HORIZON could
demonstrably take place earlier than a MATERIAL SUPPLY BREACH by BI could be
remedied, BI shall assist HORIZON as requested in transferring the MANUFACTURING
PROCESS to such a second source supplier in accordance with Section 14.4.
4.10.4 In the event that BI reasonably anticipates that there is a substantial
likelihood that a MATERIAL SUPPLY BREACH will occur, BI shall immediately notify
HORIZON in writing thereof. Upon receipt of such notice, the Parties shall
immediately confer to discuss the circumstances and magnitude of such potential
MATERIAL SUPPLY BREACH, and to determine in good faith whether there are any
steps that BI could take to avoid such MATERIAL SUPPLY BREACH. If HORIZON is not
reasonably satisfied that BI will be able to avoid such MATERIAL SUPPLY BREACH,
then HORIZON shall forward this issue to the STEERING COMMITTEE to determine
whether it is necessary or desirable to establish a second source manufacturer
to prevent such a MATERIAL SUPPLY BREACH from occurring.
4.10.5 Nothing in this Section 4.10 shall affect HORIZON's rights under
Section 14 of this AGREEMENT or any right or remedy otherwise available to
HORIZON in connection with such MATERIAL SUPPLY BREACH.
4.11 Manufacturing [...***...] Commitment
BI