variation in the forecasted quantities as set forth in Section 4.4.1 and 4.4.2.
If BI does not accept such a purchase order with respect to PRODUCT, then
HORIZON may use a secondary source manufacturer for such PRODUCT in accordance
with the procedures set forth in Section 4.10. Any other purchase order shall be
binding on BI only if it is accepted by BI, which acceptance shall not be
unreasonably withheld.
4.4.6 HORIZON shall be obligated to buy and BI shall be obligated to sell only
the quantities of EXCESS MATERIAL and/or PRODUCT which are subject to a purchase
order accepted by BI; provided that BI shall accept sufficient purchase orders
from HORIZON annually to meet its obligations pursuant to this Section 4.4 and
in accordance with the rolling forecast model pursuant to Section 4.4. Any
purchase order (or portion thereof) for which HORIZON has not received a written
rejection from BI within [...***...] of BI's receipt of such purchase order shall be
deemed accepted by BI. With respect to PRODUCTS ordered by HORIZON for its
clinical supply requirements, the number of vials supplied by BI shall not
exceed the number of vials subject to the applicable purchase order submitted by
HORIZON; provided, however, that if the number of vials BI is able to supply
falls below the number of vials ordered by HORIZON in such purchase order and
such lesser number is within a reasonable range of the number ordered by
HORIZON, BI shall notify HORIZON in writing and inquire as to whether such
lesser number of vials is acceptable and if not, whether BI should produce an
additional BATCH of DRUG SUBSTANCE to produce enough vials to satisfy HORIZON's
purchase order. If HORIZON notifies BI that such lesser number of vials is
acceptable to HORIZON, then the applicable purchase order shall be deemed to be
amended to
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4.4.7 provide for such lesser number of vials and BI shall be deemed to have
accepted such purchase order in accordance with Section 4.4 and 4.5 (and HORIZON
shall only be required to pay for the number of vials actually delivered). On
the other hand, if HORIZON notifies BI that BI should manufacture an additional
BATCH of DRUG SUBSTANCE to produce the number of vials ordered by HORIZON in its
purchase order submitted to BI, then BI shall be obligated to produce the
additional BATCH of DRUG SUBSTANCE, HORIZON shall be obligated to purchase any
excess vials (above the amounts forecasted in accordance with Section 4.4) of
PRODUCT from such additional BATCH of DRUG SUBSTANCE and the purchase order
submitted to BI by HORIZON shall be deemed amended to account for any excess
vials resulting from the additional BATCH of DRUG SUBSTANCE and such purchase
order shall be deemed accepted by BI in accordance with Section 4.4 and 4.5. In
the event HORIZON prefers to purchase any EXCESS MATERIAL of said additional
BATCH, Section 4.3.5 shall apply.
4.4.8 For the avoidance