Exhibit 10.3
***Text Omitted and Filed Separately
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2
CONFIDENTIAL
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GLOBAL SUPPLY AGREEMENT
This Global Supply Agreement (the "AGREEMENT"), is made effective as of June 30,
2017 (the "EFFECTIVE DATE") by and between
Horizon Pharma Ireland Limited
Connaught House
1 Burlington Road, Dublin 4
Ireland
(hereinafter referred to as "HORIZON")
and
Boehringer Ingelheim Biopharmaceuticals GmbH
Binger Straße 173
55216 Ingelheim am Rhein
Germany
(hereinafter referred to as "BI"),
Hereinafter HORIZON and BI may be referred to herein each individually as a
"Party" and jointly as the "Parties".
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Table of Content
1.
INTRODUCTION AND RECITALS
3
2.
DEFINITIONS
5
3.
GENERAL
13
4.
MANUFACTURE AND SUPPLY
16
5.
PRICES AND PAYMENT
28
6.
QUALITY ASSURANCE AND COMPLIANCE WITH LAW
29
7.
CO OPERATION AND CO-ORDINATION BETWEEN THE PARTIES
33
8.
INTELLECTUAL PROPERTY AND LICENSES
37
9.
COMPLAINTS; ADVERSE EVENTS; RECALLS
38
10.
REPRESENTATIONS AND WARRANTIES
39
11.
INDEMNIFICATION
41
12.
LIMITATIONS ON LIABILITY
42
13.
CONFIDENTIALITY
42
14.
DURATION AND TERMINATION
44
15.
MISCELLANEOUS
48
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CONFIDENTIAL
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1. INTRODUCTION AND RECITALS
Whereas, InterMune, Inc. ("InterMune") and Boehringer Ingelheim RCV GmbH & Co KG
("BI RCV"), an AFFILIATE (as defined hereafter) of BI, entered into a previous
supply agreement relating to the commercial supply of Actimmune® (as described
below) dated 29 June, 2007 ("RESTATED SUPPLY AGREEMENT") pursuant to the
Termination Agreement dated 6 June 2007 ("TERMINATION AGREEMENT") terminating
the Data Transfer, Clinical Trial and Market Supply Agreement dated 27 January
2000, as amended (the "ORIGINAL SUPPLY AGREEMENT"); and
Whereas, Vidara Therapeutics Research Limited ("VIDARA") (now HORIZON, as
described below) and BI RCV entered into a consolidated supply agreement
effective as of 31 July 2013, as amended (the "CONSOLIDATED SUPPLY AGREEMENT");
and
Whereas, the CONSOLIDATED SUPPLY AGREEMENT was assigned from BI RCV to its
AFFILIATE BI, effective as of 1 January 2014, via an assignment letter
acknowledged by VIDARA on 13 December 2013; and
Whereas, Vidara Therapeutics International plc, the parent company of VIDARA
merged with Horizon Pharma Public Limited Company, an AFFILIATE of HORIZON, on
19 September 2014, and as of this date VIDARA was renamed and traded as HORIZON;
and
Whereas, HORIZON's AFFILIATE Horizon Pharma Plc and BI entered into a technology
transfer and development agreement, effective as of 9 February 2015
("LYOPHILISATION DEVELOPMENT AGREEMENT") as [...***...] the CONSOLIDATED SUPPLY
AGREEMENT; and
Whereas, HORIZON terminated the LYOPHILISATION DEVELOPMENT AGREEMENT for
convenience with termination letter of 15 September 2015 and effective as of
30 September 2016; and
Whereas, HORIZON is expected to become the exclusive licensee of and the holder
of an exclusive sublicense under a license from [...***...]; and
Whereas, BII (as defined hereafter) had originally obtained exclusive licenses
from GENENTECH to manufacture, use and sell INTERFERON GAMMA 1b in Europe and
certain other territories under the trade-mark Imukin®, Immukin®, Imukine®
and/or Immukine® ("BI-
***Confidential Treatment Requested
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