shall immediately provide a representative sample of the DELIVERED
MATERIAL from the relevant shipment received by HORIZON and/or related
documentation to a mutually agreed upon, independent THIRD PARTY who shall be
responsible for determining whether the relevant DELIVERED MATERIAL rejected by
HORIZON is CONFORMING or Non-CONFORMING; and
(iv) BI shall immediately provide to such mutually agreed upon, independent
Third Party a representative sample of DELIVERED MATERIAL from the relevant
shipment delivered to HORIZON and/or all documentation relating to the
manufacture of the relevant DELIVERED MATERIAL that the independent THIRD PARTY
deems necessary to fulfil its obligations.
Both Parties shall be bound by the determination of such independent THIRD PARTY
(such determination to be made in accordance with the timelines as set forth in
the investigation plan) which determination shall be made in writing and shall
include reasoning, and the Party against which the determination is made shall
bear all costs associated with such THIRD PARTY determination, including those
of the Party in whose favour the THIRD PARTY determination is given. The
independent THIRD PARTY shall be required to enter into written undertakings of
confidentiality and non-use with respect to CONFIDENTIAL INFORMATION no less
burdensome than those set forth in this AGREEMENT.
4.7.6 Whether or not BI accepts HORIZON ́s assertion that the DELIVERED MATERIAL
rejected by HORIZON in accordance with Section 4.7.1 or 4.7.2 is Non-CONFORMING
and
***Confidential Treatment Requested
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CONFIDENTIAL
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irrespective of the independent THIRD PARTY determination referred to in
Section 4.7.5, BI shall, upon receipt of the notice of rejection, consult with
HORIZON and use commercially reasonable efforts, as soon as reasonably
practicable as mutually agreed by the Parties, to (i) provide a replacement
shipment for the DELIVERED MATERIAL rejected by HORIZON, (ii) rework or
reprocess (solely to the extent permitted under, and in accordance with, the
QUALITY ASSURANCE AGREEMENT) the Non-CONFORMING DELIVERED MATERIAL in accordance
with the Parties' quality system procedures and the Parties' mutual agreement
thereto and deliver such reworked or reprocessed DELIVERED MATERIAL to HORIZON
(which shall remain subject to the RESIDUAL SHELF LIFE provisions of
Section 4.4.4) or (iii) issue a credit note for any payments made by HORIZON for
the Non-CONFORMING DELIVERED MATERIAL.
4.7.7 If any DELIVERED MATERIAL rejected by HORIZON in accordance with
Section 4.7.1 or 4.7.2 is ultimately determined to be Non-CONFORMING or BI
accepts that the DELIVERED MATERIAL is Non-CONFORMING, BI shall bear all
expenses (including raw materials) for any manufacture and shipment of
replacement or reworked/reprocessed DELIVERED MATERIAL, provided that the
replacement cost for a vial of a cell line shall be and not exceed [...***...] (with
any costs in excess being at HORIZON's expense). In addition, BI shall make
arrangements for the return or disposal, at BI's sole discretion, of the
Non-CONFORMING DELIVERED MATERIAL, provided, however, that in the case of
PRODUCT that has been distributed (whether commercially or for clinical trials),
such PRODUCT shall be subject to Section 9.2. BI shall pay or reimburse HORIZON
for any reasonable return shipping