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GENENTECH LICENSE AGREEMENTS"). BII and HORIZON's AFFILIATE HZNP Limited entered
into an asset purchase agreement ("ASSET PURCHASE AGREEMENT"), effective as of
May 18, 2016, as amended, under which HORIZON acquired all rights, title and
interest from BII to INTERFERON GAMMA 1b, including the relevant confidential
information and trademarks, in the BII territory.
Whereas, in connection with the ASSET PURCHASE AGREEMENT, BII and HZNP Limited
anticipate that [...***...].
Whereas, BII and HORIZON, in connection with the ASSET PURCHASE AGREEMENT,
entered into a Transition Service Agreement ("TRANSITION SERVICE AGREEMENT")
effective as of 30 June 2017, covering transitional services to be provided by
BI and/or its AFFILIATES until such time as HORIZON makes HORIZON-labelled
PRODUCT available to patients; and
Whereas, BI and its AFFILIATES BI RCV and BI Pharma KG (as defined hereinafter)
own facilities specialised for cGMP manufacture of biopharmaceuticals and have
been manufacturing and supplying the ACTIMMUNE PRODUCT (as defined hereafter)
and IMUKIN PRODUCT (as defined hereafter) to BII and HORIZON, as applicable; and
Whereas, HORIZON and BI agreed in amendment No. 2 to the CONSOLIDATED SUPPLY
AGREEMENT with an effective date of 1 June 2015 ("CSA AMENDMENT NO. 2") to
harmonise the current MANUFACTURING PROCESS (Exhibit 1a, 1b of CSA AMENDMENT NO.
2) for DRUG SUBSTANCE manufacture and the manufacturing process for PRODUCT
manufacture [...***...];
Whereas, the Parties wish to enter into this GLOBAL SUPPLY AGREEMENT
("AGREEMENT") to replace the CONSOLIDATED SUPPLY AGREEMENT setting forth the
terms and conditions pursuant to which BI will on a going forward basis
manufacture and supply to HORIZON, and HORIZON will purchase from BI, DRUG
SUBSTANCE and PRODUCT to meet HORIZON's needs with respect thereto.
Now, Therefore, in consideration of the foregoing recitals which are hereby
incorporated by reference herein and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the Parties hereto
agree as follows:
***Confidential Treatment Requested
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2. DEFINITIONS
The following capitalized definitions will apply throughout this AGREEMENT:
2.1 ACTIMMUNE PRODUCT means the liquid formulation of INTERFERON GAMMA 1b
currently sold under the trademark Actimmune® and that is manufactured and
supplied under this AGREEMENT by BI as further described in Exhibit 6.
2.2 AFFILIATE means (i) any corporation or business entity fifty percent (50 %)
or more of the voting stock of which is and continues to be owned directly or
indirectly by any party hereto; (ii) any corporation or business entity which
directly or indirectly owns fifty percent (50 %) or more of the voting stock of
any party hereto; or (iii) any corporation or business entity under the direct
or indirect control of such corporation or business entity as described in
(i) or (ii).
2.3 AGREEMENT means this GLOBAL SUPPLY AGREEMENT as set forth in the recitals
above of this AGREEMENT.
2.4 APPROVAL means a regulatory approval required from a HEALTH AUTHORITY in
order to manufacture DRUG SUBSTANCE or PRODUCT for use in clinical trials or
market supply as applicable, in the