ensuring such
PERMITTED SUBCONTRACTOR's compliance with cGMP.
BI shall be responsible and liable for all activities (including omissions) of
any PERMITTED SUBCONTRACTORS in connection with this AGREEMENT as if such
activities or omissions were performed or made by BI. BI shall ensure that any
PERMITTED SUBCONTRACTORS shall be bound by written agreements consistent with
this AGREEMENT and QUALITY ASSURANCE AGREEMENT and containing:
(a) confidentiality obligations no less restrictive than those in this AGREEMENT
and (b) provisions that are sufficient to enable BI to grant INTELLECTUAL
PROPERTY RIGHTS granted to HORIZON under this AGREEMENT.
4.4 Forecasts
HORIZON shall provide a rolling forecast for [...***...] for PRODUCT in the format
set forth in Exhibit 11. For clarity, [...***...].
4.4.1 [...***...]. From the EFFECTIVE DATE until [...***...] and the manufacturing
process for PRODUCT (Exhibit 16), HORIZON agrees to order the PRODUCT in filling
lot quantities or multiples thereof (available lot sizes as of the EFFECTIVE
DATE are [...***...] vials, as follows: [...***...] of ACTIMMUNE PRODUCT and [...***...] of
IMUKIN PRODUCT per [...***...].
4.4.2 [...***...]. After [...***...] and the PRODUCT MANUFACTURING PROCESS (Exhibit 16)
with the FDA, HORIZON agrees to order the PRODUCT in filling lot quantities or
multiples thereof of [...***...] vials. HORIZON shall be obligated to purchase
amounts of PRODUCT in full lot size of [...***...] vials, under this AGREEMENT
consistent with the binding/nonbinding rolling forecast set forth in Section 4.4
above. At minimum, HORIZON shall order [...***...] vials of PRODUCT per calendar
year (prorated for partial calendar years). If HORIZON requires more PRODUCT
than set forth in the current firm forecast, BI shall use commercially
reasonable efforts in good faith to supply HORIZON with PRODUCT as requested;
provided that for the amounts of PRODUCT in excess of such forecast which BI is
unable to supply, despite such commercially reasonable
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efforts, HORIZON may use a secondary source manufacturer for PRODUCT in
accordance with the procedures set forth in Section 4.9.
4.4.3 If HORIZON reduces the forecast for [...***...], then HORIZON shall be
obligated to pay for PRODUCT which was not ordered [...***...]. Similarly, if
HORIZON reduces the forecast [...***...], then HORIZON shall be obligated to pay for
PRODUCT which was not ordered [...***...] [...***...]. BI shall mitigate HORIZON's
payment obligations under this Section 4.4.3 by allocating any available
capacity resulting from HORIZON's reduction of the forecast to a BI AFFILIATE or
a THIRD PARTY.
4.4.4 BI shall guarantee that at the date of MANUFACTURER'S RELEASE all
DELIVERED MATERIAL supplied to HORIZON shall have a minimum RESIDUAL SHELF LIFE
of not less than [...***...] based on an approved shelf life of [...***...], provided
that HORIZON shall strictly fulfill its contractual timelines regarding FINAL
RELEASE as set forth in Sections 4.7 and 5.
4.4.5 Subject to Section 4.6, BI shall ship all EXCESS MATERIAL and/or PRODUCT
by the date and in the quantities specified in the applicable purchase order. BI
shall be obligated to accept any purchase order within the range of permitted