BI storage and temperature
log documentation showing that the DRUG SUBSTANCE or PRODUCT, as applicable,
delivered to HORIZON has been stored under approprate conditions, BI warrants
(gewährleistet) that such PRODUCT shall meet the applicable stability
specifications until the end of the residual shelf-life. lt is understood that
HORIZON is responsible for the compliance with applicable laws of the regulatory
filings of the PRODUCT, and that changes and/or variations to the DRUG SUBSTANCE
SPECIFICATIONS and/or PRODUCT SPECIFICATIONS affecting the BLA or other
regulatory submissions to the BLA or any marketing authorization in the
TERRITORY shall be initiated by Horizon in accordance with the QUALITY ASSURANCE
AGREEMENT and the TRANSITION SERVICE AGREEMENT; provided that BI shall promptly
inform HORIZON in writing if updates are needed to the CMC sections of any
regulatory submissions for the DRUG SUBSTANCE or PRODUCT if it is an update that
has been requested by a HEALTH AUTHORITY or HORIZON, or if BI becomes aware of
an issue that would have impact on the registration for the DRUG SUBSTANCE or
PRODUCT (for example, as the result of a routine inspection and deficiency noted
that needs to be improved).
4.3.4 The Parties agree that that the minimum campaign length is [...***...] of
PRODUCT and thus that BI will not offer any [...***...] campaigns.
4.3.5 Supply of Excess Drug Substance
In the event of any EXCESS MATERIAL being available, HORIZON may purchase under
a CHANGE ORDER order from BI such EXCESS MATERIAL, to be supplied in accordance
with the price set forth in Exhibit 10. For clarity, EXCESS MATERIAL produced
pursuant to CSA AMENDMENT NO. 2 shall be used for development or clinical
activities, including but not limited to new PRODUCT applications, or as
otherwise permitted under the respective CHANGE ORDER, and the prices set forth
in Exhibit 10 shall apply to such EXCESS MATERIAL. The terms and conditions of
this AGREEMENT relevant for each supply of EXCESS MATERIAL shall apply hereto.
Further, and in accordance with Section , HORIZON will in no event use
any expired EXCESS MATERIAL in humans.
4.3.6 Subcontracting
Rights and obligations under this AGREEMENT may not be subcontracted by BI in
whole or in part without the prior written consent of HORIZON. Notwithstanding
the foregoing, HORIZON herewith gives express consent that BI may subcontract
the services under this AGREEMENT in whole or in part to (a) its AFFILIATE BI
RCV, (b) its AFFILIATE BI Pharma KG and (c) those subcontractors set forth in
Exhibit 13 (the entities described in subclauses (a), (b) and (c) above, and any
other subcontractor for which HORIZON gives its consent as set forth in this
Section 4.3.6, collectively referred to as "PERMITTED SUBCONTRACTORS").
Notwithstanding the foregoing, no PERMITTED SUBCONTRACTOR shall perform any
manufacturing activity under this AGREEMENT for which such PERMITTED
SUBCONTRACTOR's manufacturing facilities would be required to comply with cGMP
under applicable laws unless and until BI and
***Confidential Treatment Requested
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CONFIDENTIAL
CorA: 151373
HORIZON have entered into a written agreement with respect to