but not limited to additional regulatory
support, or extension of the scope of services or BATCHES, the Parties shall
negotiate in good faith the detailed scope, timelines
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and prices of such service. Upon HORIZON's request BI shall prepare a proposal
specifying the required services. Any agreed service shall be set forth in
writing in the form of a CHANGE ORDER. Once a CHANGE ORDER is executed, such
services or BATCH identified therein shall be subject to the terms and
conditions of this AGREEMENT.
4.2.2 For clarity, HORIZON may request DRUG SUBSTANCE supply from BI under
mutually acceptable terms, including but not limited to price, forecasting and
minimum purchase order.. HORIZON acknowledges that BI requires a minimum of
[...***...] prior notice to schedule additional BATCHES of DRUG SUBSTANCE, and BI
agrees that it will manufacture such BATCHES within this time frame, under the
condition that the Parties agree on the the mutually acceptable terms for such
BATCHES. The Parties shall negotiate in good faith such price and any other
necessary terms for manufacture and shipment of additional BATCHES of DRUG
SUBSTANCE.
4.3 General Provisions for the Services
4.3.1 BI shall [...***...] (i) manufacture and supply to HORIZON EXCESS MATERIAL in
bulk form and (ii) subject to Section 4.3.2, manufacture and supply to HORIZON
PRODUCT [...***...], using DRUG SUBSTANCE produced by BI or provided by HORIZON, to
HORIZON. BI shall not supply DRUG SUBSTANCE or PRODUCT [...***...]. However,
provided that HORIZON's rolling forecast according to Section 4.4 can be
satisfied by BI, HORIZON shall not unreasonably withhold, delay or condition any
request of BI or its AFFILIATES to use any PRODUCT to satisfy any of their own
commitments towards HEALTH AUTHORITIES or other branches of governments located
in jursidictions that are not subject to the terms of the ASSET PURCHASE
AGREEMENT. If BI manufactures and supplies PRODUCT using DRUG SUBSTANCE provided
by HORIZON or that HORIZON has purchased separately from BI [...***...].
4.3.2 HORIZON shall [...***...] purchase from BI [...***...] of HORIZON's clinical trial
supply and its market requirements for PRODUCT for the term of this AGREEMENT,
subject to Section 4.9 (Continuity of Supply). In addition, subject to a minimum
of [...***...] prior notice and the Parties reaching written agreement on all
matters set forth in Section 4.2.2, HORIZON shall [...***...] purchase from BI
[...***...] of HORIZON's requirements for DRUG SUBSTANCE for the term of this
AGREEMENT, subject to Section 4.9 (Continuity of Supply). For clarity, the
[...***...] obligation in this Section 4.3.2 shall not apply to [...***...].
4.3.3 All DRUG SUBSTANCE and PRODUCT manufactured for and/or supplied to HORIZON
by BI hereunder shall be manufactured at the FACILITY in accordance with the
DRUG SUBSTANCE SPECIFICATIONS and PRODUCT SPECIFICATIONS, respectively, the
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cGMP requirements, the QUALITY ASSURANCE AGREEMENT and all applicable laws,
regulations and ordinances in the jurisdictions in which such manufacture
occurs. Provided that HORIZON is able to provide to