Exhibit 10.61

[EXECUTION COPY]

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“***”. A COMPLETE VERSION OF THE EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT OF 1933.

CONSOLIDATED SUPPLY AGREEMENT

THIS CONSOLIDATED SUPPLY AGREEMENT (this “AGREEMENT”), is made effective as of
the 31 day of July 2013 (the “EFFECTIVE DATE”) by and between Vidara
Therapeutics Research, Ltd. (“VIDARA”), an Irish corporation, having an address
at Adelaide Chambers, Peter Street, Dublin 8, Ireland and Boehringer Ingelheim
RCV GmbH & Co KG (“BI RCV”), an Austrian limited liability partnership, having
its registered office at Dr. Boehringer-Gasse 5 – 11, A-1121 Vienna, Republic of
Austria (and successor-in-interest of Boehringer Ingelheim Austria GmbH). VIDARA
and BI RCV may be referred to herein each individually as a “Party” and jointly
as the “Parties.”

WHEREAS, VIDARA is the exclusive licensee of and the holder of an exclusive
sublicense under a license from GENENTECH (as defined herein) to manufacture,
use and sell recombinant human gamma-interferon (“INTERFERON GAMMA 1b”, as
further described herein) products in the USA and certain other territories,
which INTERFERON GAMMA 1b is approved by the FDA for the indications Chronic
Granulomatous Disease and severe, malignant Osteopetrosis, and is sold in the
USA under the trade-mark ACTIMMUNE® (the “GENENTECH PRODUCT”, as further
described herein); and

WHEREAS, Boehringer Ingelheim International GmbH (BID, an affiliate of BI RCV
and BI Pharma KG (as defined hereinafter), holds an exclusive license from
GENENTECH to manufacture, use and sell INTERFERON GAMMA 1b in certain other
territories, and is the registration-holder for an INTERFERON GAMMA 1b product
in certain countries for the indication Chronic Granulomatous Disease and is
sold in Europe under the trade-mark IMUKIN® (the “BI PRODUCT”, as further
described herein); and

WHEREAS, BI RCV and its affiliate BI Pharma KG (as defined hereinafter) own
facilities specialised for cGMP manufacture of biopharmaceuticals and
manufactures and supplies the BI PRODUCT to BII to meet BII’s needs with respect
thereto; and

WHEREAS, InterMune, Inc. (“InterMune”) and BI RCV had entered into that certain
Supply Agreement dated June 29, 2007 (“RESTATED SUPPLY AGREEMENT”) pursuant to
that certain Termination Agreement dated the 6th of June 2007 (“TERMINATION
AGREEMENT”) whereby InterMune and BI RCV had agreed, among other things, to
terminate that certain Data Transfer, Clinical Trial and Market Supply Agreement
dated the 27th of January 2000, as amended (the “ORIGINAL SUPPLY AGREEMENT”) and
enter into such Restated Supply Agreement to replace the ORIGINAL SUPPLY
AGREEMENT; and

WHEREAS, InterMune and BI RCV entered into the Amended and Restated Supply
Agreement (“AMENDED AND RESTATED SUPPLY AGREEMENT”) effective as of May 15,

 

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2012 in anticipation of the assignment of all INTERFERON GAMMA 1b product
related agreements from InterMune to VIDARA and two of VIDARA’s AFFILIATES,
Vidara Therapeutics Holdings LLC (formerly known as Vidara Therapeutics LLC) and
Vidara Therapeutics International Limited; and

WHEREAS, the Parties wish to enter into this CONSOLIDATED SUPPLY AGREEMENT
(“AGREEMENT”) to replace the AMENDED AND RESTATED SUPPLY AGREEMENT to amend and
consolidate the AMENDED AND RESTATED SUPPLY AGREEMENT which will set forth the
terms and conditions pursuant to which BI RCV will continue on a going forward
basis to manufacture and supply to VIDARA and VIDARA will purchase from BI RCV
finished INTERFERON GAMMA 1b product to meet VIDARA’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:

1. DEFINITIONS

The following capitalized definitions will apply throughout this Agreement:

1.1 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).

1.2 AMENDED AND RESTATED SUPPLY AGREEMENT has the meaning ascribed to it in the
recitals of this AGREEMENT.

1.3 APPROVAL means a regulatory approval required from a HEALTH AUTHORITY in
order to manufacture BBS or PRODUCT for use in clinical trials or market supply
as applicable, in the applicable jurisdiction.

1.4 BI RCV’S IMPROVEMENTS shall mean all INFORMATION comprising any inventions,
modifications and/or improvements to the VIDARA TECHNOLOGY or to the GENENTECH
TECHNOLOGY, that BI RCV or BI Pharma KG conceive of or reduce to practice
pursuant to the ORIGINAL SUPPLY AGREEMENT, RESTATED SUPPLY AGREEMENT and/or this
AGREEMENT, either individually or in conjunction with one or more third parties
or BI Affiliates, including all patent and patent applications covering any of
the foregoing.

1.5 BI RCV’S TECHNOLOGY means all INFORMATION in the field of manufacturing and
testing of biopharmaceuticals, including without limitation the MANUFACTURING
PROCESS but only to the extent that it relates solely to BI PRODUCT, and
including all patents and patent applications covering any of the foregoing,
that are owned or CONTROLLED by BI RCV or BI Pharma KG during the term of the
ORIGINAL SUPPLY AGREEMENT, the RESTATED SUPPLY AGREEMENT and/or this AGREEMENT
and that are related to or

 

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useful in BI RCV’s carrying out its obligations under this AGREEMENT, but
specifically excluding VIDARA’S TECHNOLOGY and BI RCV’S IMPROVEMENTS.

1.6 BII means Boehringer Ingelheim International GmbH, an AFFILIATE of BI RCV
and BI Pharma KG.

1.7 BI PHARMA KG means BI RCV’s AFFILIATE BI Pharma KG, FRG-88397 Biberach an
der Riss, Birkendorfer Straße 65, Germany, owning an FDA inspected and
cGMP-certified facility.

1.8 BI PRODUCT means the liquid formulation of INTERFERON GAMMA 1b approved in
various countries for which BII has acquired rights from GENENTECH for the
treatment of Chronic Granulomatous Disease, and manufactured by BI RCV and BI
Pharma KG for sale in Europe under the trademark IMUKIN®.

1.9 BLA means a Biologics License Application, as defined by the regulations
promulgated under the FD&C ACT, and any equivalent application with respective
HEALTH AUTHORITIES.

1.10 BULK BIOLOGICAL SUBSTANCE (BBS) means a bulk form of the PRODUCT. This bulk
form is ***                                 .

1.11 BULK SPECIFICATIONS mean the specifications for BBS listed in Exhibit 1.

1.12 cGMP means the current Good Manufacturing Practices of all applicable
HEALTH AUTHORITIES, including without limitation the FDA, and including without
limitation all applicable rules, regulations, guides and guidance, such as 21
C.F.R. parts 210 and 211 and parts 600 and 610.

1.13 CMC means the Chemistry, Manufacturing, and Controls content of a
submission to a HEALTH AUTHORITY.

1.14 COA means a Certificate of Analysis, a document listing testing parameters,
specifications and test results (in a format and detail as listed in Exhibit 2).

1.15 COC means a Certificate of Compliance confirming compliance with cGMP
regulations and signed by BI RCV’s authorised Qualified Person, the Head of
Production and the Head of Quality Assurance (in a format and such detail as
listed in Exhibit 3).

1.16 COMPONENTS means, collectively, all raw materials, consumables, resins,
equipment dedicated to the PRODUCT, and materials required to process and
package for shipment the PRODUCT in accordance with the SPECIFICATIONS.

1.17 CONFIDENTIAL INFORMATION means any proprietary INFORMATION (a) disclosed by
one Party to the other from and after the effective date of the ORIGINAL SUPPLY
AGREEMENT, or (b) developed by either Party pursuant to this AGREEMENT, except
for INFORMATION which (i) is already in the public domain at the time of its
disclosure to the receiving Party; (ii) becomes part of the public domain
through no wrongful action or omission

 

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of the receiving Party after disclosure to the receiving Party; (iii) is already
known to the receiving Party at the time of disclosure as evidenced by the
receiving Party’s written records; or (iv) is independently developed by the
receiving Party without the use or application of the disclosing Party’s
proprietary information.

1.18 CONTROLLED means, with respect to any material, INFORMATION or intellectual
property right, possession of the ability by a Party to grant access, a license,
or a sublicense to such material, INFORMATION or intellectual property right as
provided for herein without violating an agreement with a Third Party as of the
time such Party would be first required hereunder to grant the other Party such
access, license or sublicense.

1.19 EURO means a euro, which is the European unit of currency.

1.20 FDA means the United States Food and Drug Administration and any successor
agency thereto.

1.21 FD&C ACT means the United States Food, Drug & Cosmetic Act as amended from
time to time and any supplements thereunder, and any equivalent regulation of
any HEALTH AUTHORITIES.

1.22 FINAL RELEASE means the release of PRODUCT by VIDARA or its licensees for
clinical trial use or market supply, as applicable.

1.23 GENENTECH means Genetech, Inc. with its principal place of business at 1
DNA Way, South San Francisco, CA, 94080-4990.

1.24 GENENTECH PRODUCT means the formulation of INTERFERON GAMMA 1b which was
manufactured in the US by GENENTECH for sale under the trademark ACTIMMUNE and
approved by the FDA for the treatment of Chronic Granulomatous Disease and
Osteopetrosis.

1.25 GENENTECH TECHNOLOGY means all INFORMATION relating to the manufacture, use
or sale of INTERFERON GAMMA 1b that is licensed to either Party pursuant to an
agreement with GENENTECH, including without limitation the MANUFACTURING
PROCESS, and all patents and patent applications covering such INFORMATION.

1.26 HEALTH AUTHORITIES mean all regulatory authorities having jurisdiction over
the manufacture, use and/or sale of the PRODUCT in the TERRITORY, including but
not limited to the FDA.

1.27 INFORMATION means (a) techniques, data, inventions, practices, methods,
knowledge, know-how, skill, experience, test data (including pharmacological,
toxicological and clinical test data), analytical and quality control data,
regulatory submissions, correspondence and communications, marketing, pricing,
distribution, cost, sales, manufacturing, patent and legal data or descriptions,
compositions of matter, assays and biological materials, and (b) all
intellectual property rights in and to any of the foregoing.

 

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1.28 INTERFERON-GAMMA 1b means the recombinant human Interferon-Gamma 1b derived
from ***                                 that is the active ingredient in
ACTIMMUNE®. The relevant amino acid sequence is set forth in Exhibit 4.

1.29 VIDARA’S TECHNOLOGY means all INFORMATION that was or is CONTROLLED either
by InterMune or VIDARA during the term of the ORIGINAL SUPPLY AGREEMENT, the
RESTATED SUPPLY AGREEMENT, the AMENDED AND RESTATED SUPPLY AGREEMENT and/or the
term of this AGREEMENT that is related to or useful in BI RCV’s manufacture of
PRODUCT hereunder and that was acquired by VIDARA from InterMune or thereafter
developed by VIDARA, and all patents and patent applications covering any of the
foregoing; provided that “VIDARA’S TECHNOLOGY” shall not include any INFORMATION
(i) owned or CONTROLLED by BI RCV prior to the effective date of the ORIGINAL
SUPPLY AGREEMENT, (ii) conceived of, or reduced to practice or acquired by RI
RCV outside the ORIGINAL SUPPLY AGREEMENT, or the RESTATED SUPPLY AGREEMENT, or
the AMENDED AND RESTATED SUPPLY AGREEMENT during their respective terms or
outside this AGREEMENT during the term hereof, or (iii) the GENENTECH
TECHNOLOGY.

1.30 RESERVED.

1.31 MANUFACTURER’S RELEASE means the release of the PRODUCT by BI RCV to VIDARA
or its designee.

1.32 MANUFACTURING PROCESS means the process for fermentation, purification,
filling, labeling and packaging of BBS and PRODUCT, as described in Exhibit 5.

1.33 MATERIAL SUPPLY BREACH means a failure of BI RCV: (a) to supply to VIDARA
at ***                     of VIDARA’s binding forecasted requirements of
PRODUCT (or actual orders, if less) that are due for delivery by the designated
delivery date during the then-current calendar quarter; or (b) to repeatedly ***
                    materially violate against cGMP.

1.34 ORIGINAL SUPPLY AGREEMENT has the meaning ascribed to it in the recitals of
this AGREEMENT.

1.35 PRODUCT shall mean a finished product consisting of formulated INTERFERON
GAMMA 1b filled into the designated containers for clinical supply and for
market supply, as described in Exhibit 6, or shall mean a finished product of
formulation buffer filled into the designated containers for clinical supply
(placebo).

1.36 PROJECT MANAGER means the responsible person designated by each Party to be
responsible for the communication of all information concerning this AGREEMENT.
As of the Effective Date, the person designated as VIDARA’s PROJECT MANAGER and
the person designated as BI RCV’s PROJECT MANAGER are listed in Exhibit 7.
Either Party may change its own designated PROJECT MANAGER by providing written
notice thereof to the other Party.

 

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1.37 PRODUCT SPECIFICATIONS mean the specifications for the PRODUCT as set forth
in Exhibit 8, or as otherwise agreed by the Parties in writing.

1.38 PROJECT TEAM means the team as listed in Exhibit 7 and described in Section
6.1.

1.39 QUALITY AGREEMENT means that Amended and Restated Quality Agreement dated
May 15, 2012 between the Parties.

1.40 QUALITY ASSURANCE REQUIREMENTS mean those requirements set forth in the
QUALITY AGREEMENT.

1.41 RESTATED SUPPLY AGREEMENT has the meaning ascribed to it in the recitals of
this AGREEMENT.

1.42 STEERING COMMITTEE means the committee as listed in Exhibit 9 and as
further described in Section 6.2.

1.43 TERMINATION AGREEMENT has the meaning ascribed to it in the recitals of
this AGREEMENT.

1.44 TERRITORY means the US, Japan and all additional territories, including but
not limited to Canada, as to which VIDARA has or may acquire the right to
manufacture, use or sell INTERFERON GAMMA 1b products during the term of this
AGREEMENT.

1.45 US means the United States of America.

2. GENERAL

2.1 VIDARA’s Tasks and Responsibilities

2.1.1 Support

VIDARA shall timely send all documentation, and otherwise timely provide all
information and other assistance, reasonably requested by BI RCV for use under
this AGREEMENT. VIDARA shall provide such reasonable technical support at its
own expense, which support shall include access to VIDARA’s expert personnel
upon reasonable notice and at such reasonable times as the Parties may agree.

2.1.2 Contact with Health Authorities

2.1.2.1 VIDARA, as the license holder for the GENENTECH PRODUCT in the US, shall
have the overall responsibility regarding all contacts with the HEALTH
AUTHORITIES and shall be solely responsible for filing all regulatory documents
required by any HEALTH AUTHORITIES. BI RCV shall support VIDARA in all matters
regarding the manufacturing and quality control of PRODUCT as reasonably
requested by VIDARA, but VIDARA shall be the leading Party, responsible for
co-ordination of all regulatory matters.

 

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2.1.2.2 VIDARA will notify BI RCV in due time, but in no event later than five
(5) business days in advance of any meeting with any HEALTH AUTHORITIES with
regard to manufacture, supply and quality control of the PRODUCT manufactured by
BI RCV or BI Pharma KG under this AGREEMENT. BI RCV shall have the right to
participate in such meetings with such HEALTH AUTHORITIES during the portion of
such meetings relating to BI RCV’s or BI Pharma KG’s manufacture, supply and
quality control of the PRODUCT.

2.1.2.3 BI RCV will be responsible for drawing up the annual report required by
the HEALTH AUTHORITIES reasonably in advance of the due date, and will be
responsible of matters regarding the manufacture of PRODUCT. VIDARA shall submit
such report to the HEALTH AUTHORITIES and shall provide BI RCV with a copy of
the finally submitted report.

2.1.3 Shipment of Material by VIDARA

Any materials, e.g. samples, sent by VIDARA (or by a third party on behalf of
VIDARA) to BI RCV shall be made by shipment from VIDARA’s facility (or the third
party’s facility, as the case may be) to BI RCV’s facility in Vienna. Shipping
costs including insurance will be borne by VIDARA, and risk of loss in transit
shall lie with VIDARA.

2.2 BI RCV’s Tasks and Responsibilities

2.2.1 Regulatory Support

2.2.1.1 BI RCV agrees to co-operate with VIDARA in obtaining and maintaining all
US governmental approvals and registrations relevant to the CMC section of the
registration dossier (and their foreign equivalents) as requested by VIDARA.

2.2.1.2 The Parties shall consult with each other concerning the scope and
content of all regulatory filings, and shall jointly define the requirements for
the necessary PRODUCT registration with the FDA so that BI RCV shall be able to
fulfill its obligations under this AGREEMENT with respect to the CMC portion of
such PRODUCT registration. With respect to any part of the CMC portion which
contains BI RCV and/or BI Pharma KG INFORMATION, BI RCV shall be provided an
opportunity to review and comment on such parts prior to submission to a HEALTH
AUTHORITY as set forth in the QUALITY AGREEMENT.

2.2.2 Format and Content of Documents. BI RCV’s Quality Management System
demands a special format for certain documents (i.e. batch records, testing
procedures, technical reports) which is binding. For those documents where a
binding format is not obligatory the Parties shall agree in writing on a master
format. With respect to the dates contained in these documents, and in
particular in all reports and when dates occur in connection with signatures,
the European writing style shall apply. The order shall be as follows: dd / mm /
yy (day/month/year).

3. MANUFACTURE AND SUPPLY

3.1 General

3.1.1 BI RCV shall ***                     supply to VIDARA BBS or PRODUCT for
the treatment or prevention of any human disease or condition, except for
                     ***

 

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cardiac or cardiovascular disease or condition. ***                     BBS or
PRODUCT for the treatment of any human disease or condition, except for the
treatment or prevention of any type of cardiac or cardiovascular condition, ***
                                    . VIDARA shall ***
                    purchase from BI RCV, ***
                                         
                                                 PRODUCT for the term of this
AGREEMENT, subject to Section 3.7. Subject to restrictions that may be imposed
on BI RCV with respect to VIDARA’S TECHNOLOGY or to GENENTECH TECHNOLOGY ***
                                         
                                                                         
                                                                  
                                             ,         this provision does not
in any way restrict BI RCV’s right to manufacture ***   BI PRODUCT ***
                                        .

3.1.2 All BBS manufactured by BI RCV hereunder, and all PRODUCT manufactured and
supplied to VIDARA by BI RCV hereunder, shall be manufactured and supplied in
accordance with the BBS SPECIFICATIONS and PRODUCT SPECIFICATIONS, the cGMP
requirements, the QUALITY ASSURANCE REQUIREMENTS as set forth in the QUALITY
AGREEMENT and all applicable laws, regulations and ordinances of the
jurisdiction in which such manufacture occurs.

3.1.3 BI RCV shall manufacture BBS according to the BULK SPECIFICATIONS. BI RCV
shall manufacture PRODUCT according to PRODUCT SPECIFICATIONS for clinical
supply and tier market supply. BBS for clinical and market supply shall be
manufactured at BI RCV and transferred to BI Pharma KG for vialing, labeling
(but only for market supply) and packaging. Manufacturing and filling of vials,
labeling (but only for market supply) as well as the packaging and storing of
PRODUCT shall be in accordance with the PRODUCT SPECIFICATIONS, the cGMP
requirements, the QUALITY ASSURANCE REQUIREMENTS as set forth in the QUALITY
AGREEMENT and all applicable laws, regulations and ordinances of the
jurisdiction in which such manufacturing and/or filling occurs. Notwithstanding
the fact that BI RCV takes BI Pharma KG as a toll manufacturer for filling,
labeling (for market supply) and packaging of PRODUCT, BI RCV takes
responsibility for the manufacture and supply of PRODUCT to VIDARA in accordance
with the terms and conditions of this AGREEMENT.

3.2 Forecasts

3.2.1 Beginning with calendar quarter commencing on the 1st of July 2013 ***
                                    , VIDARA shall provide a rolling forecast
for the next twelve (12) quarters (36 months). ***
                                         
                                                                    
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     .

 

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3.2.2 If VIDARA requires more PRODUCT than is set forth in the current firm
forecast, BI RCV shall use commercially reasonable efforts in good faith to
supply VIDARA with PRODUCT as requested; provided that for the amounts of
PRODUCT in excess of such forecast which BI RCV is unable to supply, despite
such commercially reasonable efforts, VIDARA may use a secondary source
manufacturer in accordance with the procedures set forth in Section 3.7.

3.2.3 If VIDARA reduces the forecast ***
                                         
                                         
                                                               
                                    , then VIDARA shall be obligated to pay for
PRODUCT which was not ordered ***                                     
                                         
                                         
                                         
                                         
                                             . Similarly, if VIDARA reduces the
forecast ***                                          
                                         
                                                        , then VIDARA shall be
obligated to pay for PRODUCT which was not ordered ***
                                                                          
                                                 
                                         
                                                               .

3.3 Purchase Orders

3.3.1 VIDARA shall be obligated to purchase amounts of PRODUCT in full lot size
of ***             under this Agreement consistent with the binding/nonbinding
rolling forecast set forth in Section 3.2 above. At minimum, VIDARA shall order
***                     of PRODUCT per calendar year beginning in
***             . When purchasing PRODUCT hereunder, VIDARA shall submit written
purchase orders to BI RCV. To the extent that the terms of a purchase order or
of BI RCV’s or BI Pharma KG’s “GENERAL CONDITIONS OF SALE” are inconsistent with
the terms of this AGREEMENT, this AGREEMENT shall prevail.

3.3.2 BI RCV shall guarantee that at the date of FINAL RELEASE all PRODUCT
supplied to VIDARA shall have a minimum residual shelf life of not less
***             of PRODUCT shelf life, provided that VIDARA shall strictly
fulfill its contractual timelines regarding FINAL RELEASE as set forth in
Sections 3.5 and 5.3.

3.3.3 Subject to Section 3.4, BI RCV shall ship all PRODUCT as set forth in
Section 3.5 by the date and in the quantities specified in the applicable
purchase order. BI RCV shall be obligated to accept any purchase order within
the range of permitted variation in the forecasted quantities as set forth in
Section 3.2.1. and 3.2.2. Any other purchase order shall be binding on BI RCV
only if it is accepted by BI RCV, which acceptance shall not be unreasonably
withheld. If BI RCV does not accept such a purchase order, then VIDARA may use a
secondary source manufacturer for such purchase order in accordance with the
procedures set forth in Section 3.7.

3.3.4 VIDARA shall be obligated to buy and BI RCV shall be obligated to sell
only the quantities of PRODUCT which are subject to a purchase order accepted by
BI RCV; provided that BI RCV shall accept sufficient purchase orders from VIDARA
annually to meet its

 

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obligations pursuant to Section 3.3.1 and in accordance with the rolling
forecast model pursuant to Section 3.2.1. Any purchase order (or portion
thereof) for which VIDARA has not received a written rejection from BI RCV
within thirty (30) business days of BI RCV’s receipt of such purchase order
shall be deemed accepted by BI RCV. With respect to PRODUCTS ordered by VIDARA
for its clinical supply requirements, the number of vials supplied by BI RCV
shall not exceed the number of vials subject to the applicable purchase order
submitted by VIDARA; provided, however, that if the number of vials BI RCV is
able to supply falls below the number of vials ordered by VIDARA in such
purchase order and such lesser number is within a reasonable range of the number
ordered by VIDARA, BI RCV shall notify VIDARA in writing and inquire as to
whether such lesser number of vials is acceptable and if not, whether BI RCV
should produce an additional batch of BBS to produce enough vials to satisfy
VIDARA’s purchase order. If VIDARA notifies BI RCV that such lesser number of
vials is acceptable to VIDARA, then the applicable purchase order shall be
deemed to be amended to provide for such lesser number of vials and BI RCV shall
be deemed to have accepted such purchase order in accordance with Section 3.3.
On the other hand, if VIDARA notifies BI RCV that BI RCV should manufacture an
additional batch of BBS to produce the number of vials ordered by VIDARA in its
purchase order submitted to BI RCV, then BI RCV shall be obligated to produce
the additional batch of BBS, VIDARA shall be obligated to purchase any excess
vials of PRODUCT produced by BI RCV from such additional batch of BBS and the
purchase order submitted to BI RCV by VIDARA shall be deemed amended to account
for any excess vials resulting from the additional batch of BBS and such
purchase order shall be deemed accepted by BI RCV in accordance with
Section 3.3.

3.4 Shipment of Product and Material by BI RCV

3.4.1 The PRODUCT and all material (e.g. samples) shall be shipped
***                             either BI Pharma KG, FRG 88397 Biberach an der
Riss, Germany or BI RCV’s facility in Vienna, Austria, as the case may be, to
VIDARA or as directed by VIDARA, in accordance with Incoterms 2010 as published
by the International Chamber of Commerce and in accordance with the QUALITY
AGREEMENT. VIDARA’s designated carrier shall be used to ship PRODUCT to the site
designated by VIDARA. BI RCV shall use commercially reasonable efforts to notify
VIDARA in writing upon loading of the PRODUCT onto such designated carrier. The
Parties acknowledge and agree that the only deviation from the definition of
***                     is that ***                      shall be responsible
and bear the cost ***                     the DRUG PRODUCT onto the ***
                     carrier such that ***                                  from
BI RCV to VIDARA ***                                          
                            onto the VIDARA designated carrier. Risk of loss in
transit ***                             shall lie with VIDARA, ***
                                                                 
                                         
                                                        .

3.4.2 BI RCV will provide or will have provided assistance to VIDARA regarding
necessary procedures for exportation and/or importation of PRODUCT.

3.5 Testing and Rejection

3.5.1 Within ***                     business days of its receipt of PRODUCT at
such destination as may be designated by VIDARA, VIDARA may perform such tests
and samplings as are

 

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appropriate to determine whether such PRODUCT meets the applicable PRODUCT
SPECIFICATIONS. If VIDARA refuses acceptance of PRODUCT, then VIDARA shall
inform BI RCV in writing within ***                      further business days
of any aspect in which such PRODUCT fails to conform to the PRODUCT
SPECIFICATIONS. If BI RCV does not receive such a notice within *** business
days of VIDARA’s receipt of such PRODUCT, then VIDARA shall be deemed to have
accepted the PRODUCT; provided that VIDARA shall have the right to revoke its
acceptance of such goods if it later discovers latent defects not reasonably
discoverable at the time of receipt.

3.5.2 If BI RCV receives a notice from VIDARA pursuant to Section 3.5.1 that
VIDARA does not accept any PRODUCT supplied hereunder, then BI RCV shall
immediately start retesting the PRODUCT using the retained samples in order to
evaluate process issues and other reasons for such non-compliance.

3.5.3 Regardless of whether BI RCV agrees with VIDARA’s rejection of such
PRODUCT, if requested in writing by VIDARA, BI RCV shall use reasonable efforts
to promptly replace such allegedly defective PRODUCT, the costs of which shall
be borne as set forth in Section 3.5.4.

3.5.4 In the event that BI RCV’s re-testing does not verify VIDARA’s reasons for
rejecting such PRODUCT and VIDARA is convinced by BI RCV and agrees with BI RCV
that VIDARA’s reasons for rejecting such PRODUCT are unjustified, VIDARA shall
pay BI RCV reasonable internal and external costs for conducting such
re-testing; provided, however, that, if VIDARA is not convinced and does not
agree that VIDARA’s reasons for rejecting such PRODUCT are unjustified, the
Parties shall mutually agree on an independent laboratory that shall determine
by applying validated product-specific analytical methods whether such PRODUCT
meets the PRODUCT SPECIFICATIONS. The conclusions of this independent laboratory
shall be binding upon both Parties. If such laboratory determines that such
PRODUCT does meet the PRODUCT SPECIFICATIONS, then VIDARA shall bear the costs
for such independent laboratory and for any replacement PRODUCT manufactured and
supplied to VIDARA by BI RCV pursuant to Section 3.5.3. If such laboratory
determines that such PRODUCT does not meet the PRODUCT SPECIFICATIONS, then BI
RCV shall bear the costs for such independent laboratory and for any such
replacement of PRODUCT.

3.5.5 Neither Party may destroy any PRODUCT alleged not to meet the PRODUCT
SPECIFICATIONS until the independent laboratory determines whether such PRODUCT
meets the applicable PRODUCT SPECIFICATIONS and provides written notification to
the Parties with respect to such determination, unless BI RCV accepts VIDARA’s
basis for such rejection. Thereafter, BI RCV shall have the obligation to
destroy or have destroyed, at its cost, all such rejected PRODUCT. Upon BI RCV’s
written request and at BI RCV’s cost, VIDARA shall either destroy or return to
BI RCV any rejected PRODUCT. The Parties agree that in the event of destruction
of PRODUCT, the method of such destruction shall be in compliance with all
applicable laws, rules and regulations.

3.5.6 Claims on account of quantity, loss or damages to PRODUCT (other than
claims that such PRODUCT does not meet the PRODUCT SPECIFICATIONS and latent
defects not reasonably detectable upon inspection) will be dispatched by VIDARA
in writing within ten (10) business days following receipt thereof. BI RCV shall
use reasonable efforts to replace the

 

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quantity of goods which such claims apply, which replacement shall be at
VIDARA’s expense unless such claims are due to the negligence of BI RCV.

3.6 Second Source Manufacturer

3.6.1 BI RCV acknowledges that it is critical that VIDARA be ensured continuity
of supply of PRODUCT for use in clinical trials and market supply. BI RCV shall
ensure continuity of supply of PRODUCT for use in clinical trials and market
supply. Nevertheless, due to the potentially growing market demand of PRODUCT,
BI RCV’s ability to manufacture and supply PRODUCT shall be carefully observed.
Should at any time BI RCV have any indication that continuity of supply can not
be ensured, BI RCV shall immediately inform VIDARA thereof in writing. In this
event the matter would be immediately forwarded to the STEERING COMMITTEE to
discuss second source manufacture of PRODUCT reasonably and in good faith.

3.6.2 In the event the STEERING COMMITTEE decides that it is appropriate for
VIDARA to establish a second source manufacturer, VIDARA agrees to provide the
first opportunity to qualify as a second source manufacturer for PRODUCT to a BI
RCV AFFILIATE. If such an AFFILIATE is – as foreseeable – unable to supply
VIDARA’s PRODUCT requirements then VIDARA shall be free to choose an alternate
supplier. In this case BI RCV shall assist VIDARA in transferring the
MANUFACTURING PROCESS to a third party supplier by providing reasonable
technical assistance and documentation as necessary for a transfer to a party
well skilled in the manufacture of such biotech products at VIDARA’s cost.

3.6.3 In addition, the parties, through the STEERING COMMITTEE shall work
together in good faith to develop a risk mitigation plan to minimise any risk of
interruption in the supply of PRODUCT for use in clinical trials and market
supply, which plan may include, among other things, production of excess PRODUCT
or materials relating thereto (e.g., BBS) that can be used as a buffer and/or
the off-site storage of certain PRODUCT or materials relating thereto.

3.7 Material Supply Breach

3.7.1 In the event of a MATERIAL SUPPLY BREACH, VIDARA shall provide BI RCV
written notification of such MATERIAL SUPPLY BREACH. Upon BI RCV’s receipt of
such notice and failure to cure such MATERIAL SUPPLY BREACH within the timetable
and activity plan agreed upon the Parties to cure such MATERIAL SUPPLY BREACH,
VIDARA shall have the right to purchase from a second source manufacturer, to be
agreed upon within the STEERING COMMITTEE in accordance with Section 3.6, such
amounts of PRODUCT as necessary to offset BI RCV’s shortfall in fulfilling
VIDARA’s purchase orders for such PRODUCT (or the anticipated shortfall, in the
event of repeated (maximum two (2) times) material violation against cGMP).

In the event, that

(i) BI RCV AFFILIATE can not qualify as a second source manufacturer for PRODUCT
or

 

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(ii) in the event such a BI RCV AFFILIATE is – as foreseeable – unable to supply
VIDARA’s PRODUCT requirements and

(iii) provided that PRODUCT supply as requested by VIDARA by a different second
source manufacturer, a company experienced in manufacturing of
biopharmaceuticals derived from ***                                         ,
and selected by VIDARA could demonstrably take place earlier than a MATERIAL
SUPPLY BREACH by BI RCV could be remedied, BI RCV shall assist VIDARA as
requested in transferring the MANUFACTURING PROCESS to such a second source
supplier, to be selected by VIDARA by providing, reasonable technical assistance
and documentation relating to the manufacture, testing and supply of BBS and the
PRODUCT as necessary at BI RCV’s cost. Such second source manufacturer would
bear responsibility for putting the MANUFACTURING PROCESS in place. The total
financial commitment for reasonable technical assistance shall not exceed ***
                    .

3.7.2 In the event that BI RCV reasonably anticipates that there is a
substantial likelihood that a MATERIAL SUPPLY BREACH will occur, BI RCV shall
promptly notify VIDARA in writing thereof. Upon receipt of such notice, the
Parties shall promptly confer to discuss the circumstances and magnitude of such
potential MATERIAL SUPPLY BREACH, and to determine in good faith whether there
are any reasonable steps that BI RCV could take to avoid such MATERIAL SUPPLY
BREACH. If VIDARA is not reasonably satisfied that BI RCV will be able to avoid
such MATERIAL SUPPLY BREACH, then VIDARA shall forward this issue to the
STEERING COMMITTEE to determine whether it is necessary or desirable to
establish a second source manufacturer in accordance with Section 3.6.

4. PRICES AND PAYMENT

4.1 The prices to be paid by VIDARA for the PRODUCT provided hereunder have been
agreed to by the Parties. Initially, the price of PRODUCT for market supply a
unit of ***                          of PRODUCT and the price of one single vial
of PRODUCT for clinical supply shall be in accordance with the prices in the
table below and in accordance with the annual Rolling Forecast provided by
VIDARA.

 

*** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***
*** *** *** ***

Commencing in ***, the price for the PRODUCT will be adjusted year by year in
accordance with ***                                                 
                                         
                                         
                                         
                                         
                                                 

 

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                                                                    . Payments
by VIDARA to BI RCV under this AGREEMENT shall be in EUROS.

4.2***      will be ***                                          
                                         
                                         
                                                      
                                         
                                                     which are ***
                         at the time such ***                                 .
***                                         
                                         
                                         
                                                                  , BI RCV shall
only purchase and maintain at any given time such quantities of COMPONENTS as
reasonably necessary to manufacture and supply the PRODUCT to VIDARA in
accordance VIDARA’s forecast and this AGREEMENT and shall use reasonable efforts
to maintain the level of inventory of COMPONENTS ***                         .
***                  shall be entitled ***                                     
                                         
                                                         selected by ***
                                                              which ***
                 on verification concerning ***                     . ***
                                                      with ***                 
days’ notice of any ***                 .

4.3 BI RCV shall submit to VIDARA appropriate invoices for the price of the
PRODUCT and any fees for services agreed upon by the Parties; provided, however,
that with respect to the price of the PRODUCT, BI RCV shall submit invoices
therefor only upon ***                 PRODUCT by BI RCV according to
Section 3.4.1. The price for PRODUCT or any services agreed by the Parties shall
be paid to BI RCV no later than ***                 days after the date that BI
RCV’s invoice is received by VIDARA. Payment of the invoice amounts shall be
made in Austria, ***                 , into an account with such Austrian credit
institution as shall be notified by BI RCV to VIDARA from time to time.

4.4 All payments owed to BI RCV by VIDARA on the basis of accounts rendered
shall be made in such a way that ***                 shall ***
                                         
                                         
                                         
                                                               on such ***
                                                             
                                                     
                            . In the event of a default in payment for whatever
reason, default interest at a rate of *** p.a. shall be payable on the
outstanding amount due. BI RCV reserves the right to claim any damage exceeding
such amount that shall have been caused by such delay, subject to Section 11.1.

5. QUALITY ASSURANCE AND COMPLIANCE WITH LAW

5.1 Quality Agreement. Simultaneously with the execution of this Agreement, or
prior to such execution, the Parties shall execute the QUALITY AGREEMENT. Such
QUALITY AGREEMENT is hereby incorporated by reference herein and that it shall
apply to any BBS and PRODUCT produced under this Agreement. The QUALITY
AGREEMENT shall in no way determine liability or financial responsibility of the
Parties for the responsibilities set forth therein. In the event of a conflict
between any of the provisions of this Agreement and the QUALITY AGREEMENT, the
provisions of this Agreement shall prevail. The QUALITY AGREEMENT may be amended
from time to time by the Parties only in accordance with Section 14.9.

 

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5.2 Manufacturing Facilities

BI RCV represents and warrants that it and BI Pharma KG shall obtain all
relevant APPROVALS required by the relevant HEALTH AUTHORITIES for each of their
respective manufacturing facilities and that each of their respective
manufacturing facilities conform, and will during the term of this AGREEMENT
conform, to the cGMP.

5.3 Compliance with Law

5.3.1 BI RCV shall comply, and shall ensure that its subcontractor BI Pharma KG
shall comply with, all local applicable rules, laws and regulations (including
without limitation cGMP) in performing its obligations under this AGREEMENT.
VIDARA shall comply with all applicable rules, laws and regulations in
performing its obligations under this AGREEMENT.

5.3.2 All costs in connection with maintaining BI RCV’s and BI Pharma KG’s
compliance with all applicable local regulatory requirements and cGMP in
performing under this AGREEMENT, including but not limited to the maintenance
and upgrading of all technical facilities and infrastructure and the training of
personnel, shall be borne by BI RCV. BI RCV shall obtain and maintain, and shall
ensure that BI Pharma KG obtains and maintains, all permits and licenses
necessary to its performance under this AGREEMENT at their own expense. All
costs in connection with any requirements by VIDARA or a HEALTH AUTHORITY which
relate specifically and solely to the PRODUCT (and not also to the BI PRODUCT)
shall be solely borne by VIDARA. All costs in connection with any requirements
by a HEALTH AUTHORITY which relate to the PRODUCT and the BI PRODUCT shall be
equally borne by VIDARA and BI RCV. For purposes of clarity, all costs in
connection with any requirements by BI RCV or a regulatory authority having
jurisdiction over the manufacture, use and/or sale of the BI PRODUCT which
relate specifically and solely to the BI PRODUCT (and not also to the PRODUCT)
shall be solely borne by BI RCV.

5.3.3 If a Health Authority requests or requires that a change be made to the
PRODUCT SPECIFICATIONS or the MANUFACTURING PROCESS, then BI RCV shall make such
changes in accordance with the QUALITY AGREEMENT and SOPs (i.e., change control
procedures) agreed in writing by VIDARA and BI RCV. Those changes are subject to
written approval of each Party, which approval shall not he unreasonably
withheld or delayed. In case that a request from a Health Authority may be
challenged by either Party, VIDARA and/or BI RCV shall use commercially
reasonable efforts to challenge the Health Authority on its decision and shall
assist each other in its communication with the pertinent Health Authority
requesting such a change. The costs for such a change shall be allocated between
the Parties according to Section 5.3.2.

5.3.4 If VIDARA desires (for any reason other than a request or requirement by a
Health Authority), to change the PRODUCT SPECIFICATIONS or the MANUFACTURING
PROCESS, which relate specifically and solely to the PRODUCT (and not also to
the BI PRODUCT), then BI RCV shall use reasonable commercial efforts to
accommodate such request, subject to the following:

 

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5.3.4.1 VIDARA shall promptly advise BI RCV and/or BI PHARMA KG in writing of
any such change(s), and provide information necessary for BI RCV and/or BI
PHARMA KG to evaluate the effect of such change(s). BI RCV shall promptly advise
VIDARA as to scheduling changes, if any, which may result from such change(s).
The notification and approval procedure shall be in accordance with standard
operating procedures (i.e. change control procedures) agreed by the Parties from
time to time, as described in the QUALITY AGREEMENT. The Parties shall hold a
meeting in a timely manner to discuss such changes as appropriate.

5.3.4.2 Prior to implementation of any change(s), BI RCV shall provide VIDARA
with a quote of the price of the services (which price shall be reasonable in
nature and consistent with industry standards) and COMPONENTS that will be
provided and purchased by BI RCV in order to implement any such change(s) to the
PRODUCT SPECIFICATIONS or the MANUFACTURING PROCESS, including, but not limited
to, the price of BI RCV’s validation and analytical services. If such changes
will be implemented, then VIDARA shall pay the price of the services and
COMPONENTS described in this Section.

5.3.4.3 BI RCV shall make changes or cause BI PHARMA KG to make these changes as
described in this Section in accordance with timelines agreed to by the Parties,
except that BI RCV and/or BI PHARMA KG shall have no obligation to make any such
change where doing so, (i) in BI RCV’s reasonable judgment after due
consultation with legal counsel having experience in such matters, which shall
be communicated in writing to VIDARA, would violate any applicable law or
regulations, or (ii) has a material adverse effect upon any regulatory filings
for other BI RCV or BI PHARMA KG’s products, or (iii) would be incompatible with
BI RCV’s and/or BI PHARMA KG’s established operations for biopharmaceuticals.
For all changes requested by VIDARA, BI RCV shall cooperate with VIDARA in good
faith to implement all agreed upon changes to PRODUCT SPECIFICATIONS or the
MANUFACTURING PROCESS in accordance with the timelines agreed to by the Parties
according to this Section 5.3.4.3.

5.3.5 VIDARA acknowledges and agrees that the Parties must agree in advance as
of which point in time and to which manufacture of batches of PRODUCT changes to
the PRODUCT SPECIFICATIONS or the MANUFACTURING PROCESS apply. However, VIDARA
acknowledges and agrees that changes to the PRODUCT SPECIFICATIONS or the
MANUFACTURING PROCESS during an ongoing campaign are not possible.

5.3.6 If any changes to the PRODUCT SPECIFICATIONS or the MANUFACTURING PROCESS
render obsolete or unusable any COMPONENTS and if and to the extent those
COMPONENTS may not be returned to the appropriate vendor for a credit, BI RCV
and/or BI PHARMA KG, as applicable, shall either destroy or deliver to VIDARA,
at VIDARA sole option, those obsolete or unusable COMPONENTS. VIDARA shall
reimburse BI RCV for the costs of such COMPONENTS destroyed or provided to
VIDARA to the extent the amount of COMPONENTS that would have been reasonably
required for DI RCV and/or BI PHARMA KG to maintain in inventory in order to
meet its obligations under this Agreement (consistent with its obligations under
Section 4.2 hereof with respect to the COMPONENTS).

5.3.7 VIDARA may request additional regulatory services support from BI RCV
(e.g., those set forth in Sections 2.1.2.1 and 2.2) with respect to the PRODUCT,
in support of either obtaining or maintaining regulatory approval in any country
of the TERRITORY. In such event,

 

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BI RCV shall provide a quote of the price of such services (which pricing shall
be reasonable in nature and consistent with industry standards), and shall
provide such additional regulatory services upon mutual agreement on the scope
and price of such services. For purposes of clarity and notwithstanding anything
to the contrary contained in this Agreement, for purposes of maintaining
regulatory approvals existing as of the EFFECTIVE DATE of this Agreement in any
country of the TERRITORY, BI RCV will draw up the annual report required by the
HEALTH AUTHORITIES pursuant to Section 2.1.2.3, assist in routine regulatory
inspection with HEALTH AUTHORITIES and conduct annual stability studies without
additional cost or expense to VIDARA. VIDARA will inform BI RCV in due time
which regulatory support is requested from BI RCV.

5.4 Environmental

BI RCV shall, and shall ensure that BI Pharma KG shall, properly dispose of any
and all hazardous waste materials involved with the manufacture of BBS and
PRODUCT that are generated or resulting from the activities performed hereunder,
if any, in full compliance with all applicable local laws and regulations at BI
RCV’s sole liability and expense.

6. CO-OPERATION AND CO-ORDINATION BETWEEN THE PARTIES

6.1 Project Team

6.1.1 The day-to-day responsibilities of the Parties with respect to this
AGREEMENT shall be overseen by the PROJECT TEAM, which shall be responsible for
deciding operational and scientific issues arising out of this AGREEMENT and
unanimously agreeing in good faith with respect to the monitoring of the
compliance with this AGREEMENT.

6.1.2 The PROJECT TEAM shall consist of a team consisting of equal numbers of
people, if feasible, each appointed by VIDARA and BI RCV and notified to the
other, which appointees may be changed from time to time by the appointing Party
on written notice to the other Party. Each member of the PROJECT TEAM shall be a
person of appropriate skill and experience. Either Party may change its own
designated PROJECT TEAM members provided, however that the total number of
members of the PROJECT TEAM may not be changed if feasible, nor the number of
members representing VIDARA decreased, without the Parties’ prior written
agreement. VIDARA’s and BI RCV’s respective members of the PROJECT TEAM as of
the Effective Date are listed in Exhibit 7.

6.1.3 During the term of this AGREEMENT, the PROJECT TEAM shall meet regularly
to communicate updates and provide a forum for decision-making and rapid
resolution of issues arising under this AGREEMENT. Meetings of the PROJECT TEAM
may be conducted by telephone conference, videoconference or face-to-face
meetings as agreed by the PROJECT TEAM.

6.1.4 Decisions of the PROJECT TEAM shall be reflected in the approved minutes.
Meeting minutes shall be prepared jointly by the PROJECT MANAGERS to record all
issues discussed and decisions. Minutes that have not been objected to in
writing by a Party within six (6) business days of receipt thereof shall be
deemed approved by such Party and followed by issuance of the minutes duly
executed by the Parties’ PROJECT MANAGER.

 

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6.1.5 In the event that the PROJECT TEAM is unable to reach agreement on any
issue and is unable to make decisions arising out of operational and scientific
issues within ten (10) business days, each Party may call in an expert of its
own choice to render advice to the PROJECT TEAM. Based on the advice of such
expert(s) and the team members’ know-how, the PROJECT TEAM will try to resolve
such issue. In the event that the PROJECT TEAM fails to reach agreement on an
issue within thirty (30) business days of first undertaking resolution of such
issue, such issue shall then be referred to the STEERING COMMITTEE for immediate
resolution.

6.2 Steering Committee

6.2.1 The Parties shall create a STEERING COMMITTEE consisting of the PROJECT
MANAGER of each Party and authorized representatives who shall be appointed by
VIDARA and by BI RCV in equal numbers, if feasible, and notified to the other
Party. The STEERING COMMITTEE shall be responsible for unanimously agreeing in
good faith all issues on which the PROJECT TEAM has been unable to reach
agreement and, where possible, make decisions arising out of such issues as well
as carry out the specific functions, including but not limited to decisions with
an impact on costs and timelines of any activities to be carried out under this
AGREEMENT. Each Party may change its own designated STEERING COMMITTEE members
by providing written notice thereof to the other Party; provided, however that
the total number of members of the STEERING COMMITTEE may not be changed, if
feasible, nor the number of members representing VIDARA decreased, without the
Parties’ prior written agreement. The members of the STEERING COMMITTEE are
listed in Exhibit 9.

6.2.2 The STEERING COMMITTEE shall attempt in good faith to expeditiously and
fairly resolve all issues before it. In the event that the STEERING COMMITTEE is
unable to resolve any issue before it within fifteen (15) business days from the
date that such issue is referred to it, such issue shall be referred to the
Chief Executive Officer of VIDARA and the Chief Executive Officer of BI RCV for
prompt, good faith resolution. If such individuals do not reach agreement on
such issue within fifteen (15) days of such referral, then each Party shall be
free to pursue all available legal and/or equitable remedies.

6.3 Limitation of Powers

The powers of the PROJECT TEAM and the STEERING COMMITTEE are limited to those
expressly set forth in this AGREEMENT. Without limiting the generality of the
foregoing, neither the PROJECT TEAM nor the STEERING COMMITTEE shall have the
right to amend this AGREEMENT. The actions of the PROJECT TEAM and/or the
STEERING COMMITTEE shall not substitute for either Party’s ability to exercise
any right, nor excuse the performance of any obligation, set forth herein.

7. INTELLECTUAL PROPERTY AND LICENSES

7.1 The ownership of VIDARA’S TECHNOLOGY and shall remain with VIDARA and shall
not vest in BI RCV.

7.2 The ownership of BI RCV’S TECHNOLOGY shall remain with BI RCV and shall not
vest in VIDARA.

 

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7.3 BI RCV shall retain ownership of BI RCV’S IMPROVEMENTS. BI RCV hereby grants
to VIDARA a non exclusive, perpetual, sublicenseable, royalty free license under
BI RCV’S IMPROVEMENTS (i) to the extent necessary to develop, use, import, offer
for sale and sell products containing INTERFERON GAMMA 1b in the name and on the
account of VIDARA in the TERRITORY, and (ii) in the event VIDARA transfer the
process to a second source manufacturer as permitted under this AGREEMENT, to
make and have made products containing INTERFERON GAMMA 1b in the name and on
account of VIDARA in the TERRITORY, whereby in each case VIDARA shall assume the
costs to be paid by BI RCV for awards to inventors of BI RCV’S IMPROVEMENTS, as
such awards are set forth in written agreements between BI RCV and such inventor
or in an applicable industry labor contract or mandatory by Austrian laws.

7.4 The Parties shall each have an undivided one-half ownership interest in any
INFORMATION jointly conceived of or reduced to practice by the Parties pursuant
to the ORIGINAL SUPPLY AGREEMENT, the RESTATED SUPPLY AGREEMENT, the AMENDED AND
RESTATED AGREEMENT and/or this AGREEMENT (“JOINT INFORMATION”). VIDARA shall
***                     of any JOINT INFORMATION that comprises (a) any
regulatory filing (or documentation and raw data relating thereto) relating to
PRODUCT manufactured hereunder or the ORIGINAL SUPPLY AGREEMENT, the RESTATED
SUPPLY AGREEMENT or the AMENDED AND RESTATED AGREEMENT, or (b) any manufacturing
documentation (including without limitation batch records) relating to PRODUCT
manufactured hereunder or the ORIGINAL SUPPLY AGREEMENT, the RESTATED SUPPLY
AGREEMENT or the AMENDED AND RESTATED AGREEMENT (“PRODUCT INFORMATION”). Upon
request by VIDARA, without additional consideration, BI RCV agrees to promptly
execute documents, testify and take other acts at VIDARA’s expense as VIDARA may
deem necessary or desirable to procure, maintain, perfect, and enforce the full
benefits, enjoyment, rights, title and interest of the PRODUCT INFORMATION, on a
worldwide basis. In the event VIDARA is unable for any reason, after reasonable
effort, to secure BI RCV’s signature on any document needed in connection with
the actions specified in this Section 7.4, BI RCV hereby irrevocably designates
and appoints VIDARA and its duly authorised officers and agents as its agent and
attorney in fact, which appointment is coupled with an interest, to act for and
in its behalf to execute, verify and file any such documents and to do all other
lawfully permitted acts to further the purposes of this Section 7.4 with the
same legal force and effect as if executed by BI RCV.

7.5 VIDARA hereby grants to BI RCV (with the right to sublicense solely to BI
Pharma KG) a non-exclusive, nontransferable license to use VIDARA’S TECHNOLOGY
solely for the purpose of manufacturing PRODUCT for VIDARA, as provided in this
AGREEMENT. The license granted under this Section shall automatically terminate
upon the expiration or termination of this AGREEMENT.

7.6 New Indications

7.6.1 In the event that VIDARA receives approval in the TERRITORY to
commercially sell PRODUCT for indications other than Chronic Granulomatous
Disease and severe, malignant Osteopetrosis, and provided that VIDARA has the
right to grant a license to BII in the BI

 

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TERRITORY to make, use and sell PRODUCT for such additional indications (a “NEW
INDICATIONS LICENSE”), VIDARA shall provide BII written notice thereof.

7.6.2 BII shall notify VIDARA in writing within thirty (30) days of VIDARA’s
notice (the “NOTIFICATION PERIOD”) whether BII desires to obtain a NEW
INDICATIONS LICENSE. If VIDARA does not receive written notice from BII during
the NOTIFICATION PERIOD that BII desires to obtain a NEW INDICATIONS LICENSE,
then VIDARA shall have no further obligations under this Section 7.6. If VIDARA
does receive written notice from BII that BII desires to obtain a NEW
INDICATIONS LICENSE, then BII and VIDARA shall engage in good faith negotiations
for sixty (60) business days thereafter regarding the reasonable commercial
terms upon which VIDARA would be willing to grant such a license. If at the end
of such sixty (60) business day period, BII and VIDARA have not entered into a
written agreement under which VIDARA grants a NEW INDICATIONS LICENSE to BII,
then VIDARA shall have no further obligation under this Section 7.6.

8. COMPLAINTS; ADVERSE EVENTS; RECALLS

8.1 VIDARA shall inform BI RCV of any complaints, adverse reaction reports,
safety issues or toxicity issues relating to any PRODUCT of which it becomes
aware, regardless of the origin of such information, pursuant to the terms set
forth in the QUALITY AGREEMENT.

8.1.1 VIDARA shall retain and manage complaints in accordance with cGMP. The
Parties hereby agree to cooperate with one another and with any HEALTH AUTHORITY
in the evaluation and investigation of any complaint, claim or adverse reaction
report related to the manufacture of such PRODUCT with the intention of
complying with cGMP.

8.1.2 If any such event occurs, BI RCV shall retain any unused supplies of such
PRODUCT and its associated components, and all associated batch and other
production records in such manner as VIDARA may reasonably direct, and at
VIDARA’s expense, except to the extent such event is caused by BI RCV’s wrongful
act or omission. BI RCV agrees to respond to VIDARA in respect to such complaint
investigations involving BI RCV’s manufacturing of a PRODUCT hereunder as soon
as reasonably possible but in any case within thirty (30) days from receipt by
BI RCV of the report of such complaint and sample (if available), or in the case
of a serious adverse event, within ten (10) days from receipt of the report of
such complaint and sample (if available). VIDARA and/or its designee shall serve
as the sole point of contact with the FDA or other applicable HEALTH AUTHORITY
concerning any complaints, adverse reaction reports, safety issues or toxicity
issues with respect to PRODUCT.

8.2 If either Party becomes aware at any time of any defect or the possibility
of any defect associated with any PRODUCT manufactured by BI RCV hereunder, such
Party will notify the other Party immediately and confirm the notification
within two (2) days in writing.

8.3 VIDARA shall notify BI RCV within one (1) day if any PRODUCT manufactured by
BI RCV hereunder is the subject of a recall, market withdrawal or correction,
and VIDARA and/or its designee shall have the sole responsibility for the
handling and disposition of such recall, market withdrawal or correction. In the
event that a recall is required in connection with BI RCV’s breach of any of its
warranties set forth in Section 9.2 hereof, BI RCV shall reimburse

 

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VIDARA for the purchase price of such PRODUCT and all other reasonable costs and
expenses associated with such PRODUCT recall, market withdrawal or correction,
but only to the extent that the foregoing costs and expenses are attributable to
BI RCV’s breach of its warranties hereunder. In all other events of a recall,
all costs and expenses incurred in connection with such PRODUCT recall shall be
borne by VIDARA. VIDARA and/or its designee shall serve as the sole point of
contact with the FDA or other applicable HEALTH AUTHORITY concerning any recall,
market withdrawal or correction with respect to the PRODUCT.

8.4 Insurance

During the term of this AGREEMENT, the Parties shall maintain product liability
insurance in such amounts and with such scope of coverage as are adequate to
cover the Parties’ obligations under this AGREEMENT and as appropriate for
companies of like size, taking into account the scope of activities contemplated
herein. Notwithstanding the foregoing the Parties shall maintain minimum limits
of product liability of ***                 US$ per occurrence and in the
aggregate annually. The Parties shall provide to each other within ten
(10) business days of execution of this AGREEMENT and thereafter, once a year
upon the other Party’s request, a certificate of insurance evidencing the
respective Party’s product liability insurance. In addition to the foregoing
coverage, the Parties shall maintain Comprehensive General Liability Insurance
for limits of not less than ***                 US$ per occurrence and in the
aggregate annually for bodily injury and property damage.

9. REPRESENTATIONS AND WARRANTIES

9.1 Each Party hereby represents and warrants to the other Party that: (a) the
person executing this AGREEMENT is authorized to execute this AGREEMENT;
(b) this AGREEMENT is legal and valid and the obligations binding upon such
Party are enforceable by their terms; and (c) the execution, delivery and
performance of this AGREEMENT does not conflict with any agreement, instrument
or understanding, oral or written, to which such Party may be bound, nor violate
any law or regulation of any court, governmental body or administrative or other
agency having jurisdiction over it.

9.2 BI RCV represents and warrants that:

9.2.1 All BBS manufactured hereunder shall conform to BULK SPECIFICATIONS;

9.2.2 All PRODUCT manufactured and supplied hereunder shall – at the date of
shipment – conform to the PRODUCT SPECIFICATIONS;

9.2.3 All BBS and PRODUCT manufactured and supplied hereunder shall be
manufactured in accordance with the MANUFACTURING PROCESS;

9.2.4 All BBS and PRODUCT manufactured hereunder shall be manufactured, handled,
stored, labeled, packaged and transported (from BI RCV to BI Pharma KG) in
accordance with the cGMP requirements, the QUALITY ASSURANCE REQUIREMENTS as set
forth in the QUALITY AGREEMENT and all applicable laws, regulations and
ordinances of the jurisdiction in which such manufacture occurs.

 

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9.2.5 No PRODUCT manufactured and supplied to VIDARA hereunder shall be
(i) adulterated or misbranded by BI RCV within the meaning of the FD&C Act, or
(ii) an article that may not be introduced into interstate commerce under the
provisions of Sections 404 or 505 of the FD&C Act; and

9.2.6 BI RCV shall not use and shall secure that BI Pharma KG shall not use in
any capacity the services of any persons debarred under 21 U.S.C. sections 335
(a) and 335 (b) in connection with the manufacture of the PRODUCT under this
AGREEMENT.

9.3 Except as expressly provided for herein, BI RCV makes no further warranties
of the merchantability or fitness of the PRODUCT or any warranties of any other
nature, express or implied.

10. INDEMNIFICATION

10.1 Subject to Section 10.3, BI RCV shall indemnify, defend and hold harmless
VIDARA and its officers, directors, employees and agents from and against all
third party costs, claims, (including death and bodily injury) suits, expenses
(including reasonable attorneys’ fees), liabilities and damages (collectively,
“LIABILITIES”) arising out of or resulting from any willful or negligent act or
omission by BI RCV or BI Pharma KG relating to the subject matter of this
AGREEMENT, or any defect in the manufacture or any failure to deliver PRODUCT in
accordance with BI RCV’s warranties (except to the extent such LIABILITIES arose
or resulted from any negligent act or omission by VIDARA).

10.2 Subject to Section 10.3, VIDARA shall indemnify, defend and hold harmless
BI RCV and its officers, directors, employees and agents from and against all
LIABILITIES arising out of or resulting from any willful or negligent act or
omission by VIDARA relating to the subject matter of this AGREEMENT, or the use
by or administration to any person of a PRODUCT manufactured by BI RCV in
performance of its obligations under this AGREEMENT (except to the extent such
LIABILITIES arose or resulted from any negligent act or omission by BI RCV or BI
Pharma KG or any defect in the manufacture of PRODUCT or any failure to deliver
PRODUCT in accordance with BI RCV’s warranties).

10.3 A Party and its directors, officers, employees and agents which intends to
claim indemnification under this Article 10 (each, an “INDEMNITEE”) shall
promptly notify the other Party (the “INDEMNITOR”) in writing of any action,
claim or other matter in respect of which the INDEMNITEE intend to claim such
indemnification; provided, however, that the failure to provide such notice
within a reasonable period of time shall not relieve the INDEMNITOR of any of
its obligations hereunder except to the extent that the INDEMNITOR is prejudiced
by such failure. The INDEMNITEE shall permit the INDEMNITOR at its discretion to
settle any such action, claim or other matter, and the INDEMNITEE agrees to the
complete control of such defense or settlement by the INDEMNITOR.
Notwithstanding the foregoing, the INDEMNITOR shall not enter into any
settlement that would adversely affect the INDEMNITEE’s rights hereunder, or
impose any obligations on the INDEMNITEE in addition to those set forth herein
in order for it to exercise such rights, without INDEMNITEE’s prior written
consent, which shall not be unreasonably withheld or delayed. No such action,
claim or other matter shall be settled without the prior written consent of the
INDEMNITOR, which shall

 

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not be unreasonably withheld or delayed. The INDEMNITOR shall not be responsible
for any attorneys’ fees or other costs incurred other than as provided herein.
The INDEMNITEE shall cooperate fully with the INDEMNITOR and its legal
representatives in the investigation and defense of any action, claim or other
matter covered by the indemnification obligations of this Article 10. The
INDEMNITEE shall have the right, but not the obligation, to be represented in
such defense by counsel of its own selection and at its own expense.

11. LIMITATIONS ON LIABILITY

11.1 In no event shall either Party be liable to the other Party for any
consequential, incidental, special or indirect damages arising in connection
with this AGREEMENT except in the case of willful misconduct or omission by such
Party.

11.2 Except as set forth in the following sentence, BI RCV’s total liability
under this Agreement shall not exceed ***

                                                                    
                                                                              .
However, with respect to BI RCV’s indemnification obligations under Article 10,
BI RCV’s total liability shall not exceed ***                 per occurrence of
an act or omission by BI RCV giving rise to a claim for indemnification by
VIDARA against BI RCV under Article 10, except in the event of BI RCV’s willful
misconduct.

12. CONFIDENTIALITY

12.1 Each Party shall treat confidentially all CONFIDENTIAL INFORMATION of the
other Party, and shall not use or disclose such CONFIDENTIAL INFORMATION other
than it is expressly permitted under this AGREEMENT. Each Party will take steps
to protect the other Party’s CONFIDENTIAL INFORMATION that are at least as
stringent as the steps such Party uses to protect its own CONFIDENTIAL
INFORMATION, but in no event shall be less than reasonable. Each Party may
disclose the other Party’s CONFIDENTIAL INFORMATION to employees, contractors
and agents who are bound by written obligations of confidentiality and non-use
consistent with those set forth in this AGREEMENT. BI RCV may disclose
CONFIDENTIAL INFORMATION for corporate reporting purposes to its AFFILIATES BI
Pharma KG and Boehringer Ingelheim GmbH.

12.2 Each Party may disclose Confidential Information of the other Party
hereunder to the extent that such disclosure is reasonably necessary for
prosecuting or defending litigation, complying with applicable government
regulations, conducting preclinical or clinical trials or obtaining marketing
approval for the PRODUCT, provided that if a Party is required by law or
regulation to make any such disclosure of the other Party’s CONFIDENTIAL
INFORMATION it will, except where impracticable for necessary disclosures, for
example in the event of medical emergency, give reasonable advance notice to the
other Party of such disclosure requirement and will use its best efforts assist
such other Party to secure a protective order or confidential treatment of such
CONFIDENTIAL INFORMATION required to be disclosed.

12.3 Neither Party shall disclose CONFIDENTIAL INFORMATION of the other Party in
any patent filings without the prior written consent of such other Party.

12.4 The Parties agree that, except as may otherwise be required by applicable
laws, regulations, rules, or orders, including without limitation the rules and
regulations promulgated

 

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by the US Securities and Exchange Commission, and except as may be authorised in
Section 12.2, no material information concerning this AGREEMENT and the
transactions contemplated herein shall be made public by either Party without
the prior written consent of the other. The Parties agree that the public
announcement of the execution of this AGREEMENT shall be by one or more press
releases mutually agreed to by the Parties. A failure of a Party to return a
draft of a press release with its proposed amendments or modifications to such
press release to the other Party within five (5) business days of such Party’s
receipt of such press release shall be deemed as such Party’s approval of such
press release as received by such Party. Each Party agrees that it shall
cooperate fully and in a timely manner with the other with respect to all
disclosures to the Securities and Exchange Commission and any other governmental
and regulatory agencies, including requests for confidential treatment of
CONFIDENTIAL INFORMATION of either Party included in any such disclosure.

12.5 This confidentiality obligations of this Article 12 shall survive the
termination or expiration of this AGREEMENT for a period of five (5) years.

13. DURATION AND TERMINATION

13.1 Duration

The AGREEMENT shall be effective as of the Effective Date and shall continue in
force until 31 July, 2020. No later than ***                 prior to the
expiration of this AGREEMENT, the Parties shall discuss and determine whether
the term of the AGREEMENT shall be extended by the Parties. In the event the
Parties mutually determine that the term of the AGREEMENT should be extended,
the Parties shall enter into an amendment to this AGREEMENT to effectuate such
an extension. Where the Parties have so mutually determined to extend the term
of the AGREEMENT as provided herein, but are subsequently unable following good
faith negotiation to agree on the terms of an amendment, then the term of this
AGREEMENT shall end on 31 July, 2020 or ***                 from the date the
Parties mutually agree to cease negotiations of an extension, whichever occurs
later.

13.2 Early Termination

13.2.1 In the event that a Party materially breaches its obligations under this
AGREEMENT (including without limitation a MATERIAL SUPPLY BREACH and a late
payment of more than thirty (30) days), the non-breaching Party may terminate
this AGREEMENT upon thirty (30) days prior written notice to the breaching
Party, unless the breaching Party cures such breach to the non-breaching Party’s
reasonable satisfaction during such thirty day period. Notwithstanding the
preceding sentence, in the event that a Party materially breaches its
obligations under this AGREEMENT more than two (2) times in any consecutive
twenty-four (24) month period, the non-breaching Party may terminate this
AGREEMENT immediately without providing the breaching Party an opportunity to
cure such breach, by giving the breaching Party written notice thereof.

13.2.2 Each Party may terminate this AGREEMENT by notice in writing to the other
Party, for cause, if such other Party is adjudicated to be insolvent or files a
petition in bankruptcy.

 

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13.2.3 VIDARA may immediately terminate this AGREEMENT by notice in writing if
VIDARA should be prevented by the HEALTH AUTHORITIES from distributing PRODUCT
on the market for all indications. In such event,
***                                 for the following: (A) VIDARA shall either
(at VIDARA’s discretion) (i) ***                         in accordance with the
then existing ***             under the ***                             (in
which case ***                                         
                                    or
(ii) ***                                              of the unit price of the
PRODUCT then in effect for the PRODUCT forecasted in the then existing
***             under the ***             ; and
(B) ***                                                              any
non-cancelable costs incurred by BI RCV for COMPONENTS which were purchased by
BI RCV at VIDARA’s request to the extent that VIDARA has not yet paid for such
COMPONENTS; provided that VIDARA shall have no liability to BI RCV under this
Section 13.2.3 in the event that such HEALTH AUTHORITY action is solely due to
any breach of BI RCV’s warranties under this Agreement or any negligence or
willful misconduct by BI RCV or BI Pharma KG.

13.2.4 All payments in connection with early termination shall be due within
thirty (30) days after receipt by BI RCV of the notice of early termination from
VIDARA and receipt by VIDARA of the respective invoice from BI RCV.

13.3 Effect of Termination

13.3.1 In the event of any termination of this AGREEMENT (other than for BI
RCV’s material breach or negligence or willful misconduct by BI RCV or BI Pharma
KG), VIDARA shall also do one of the following (at VIDARA’s option): (i) VIDARA
shall purchase (in which case BI RCV shall sell) PRODUCT ***
                                         
                                                                            
                                                                     (ii) VIDARA
shall pay to BI RCV an amount equal to ***                         of the unit
price of the PRODUCT then in effect for the PRODUCT
***                                     ;             provided, however, that
with regard to any ***                         by BI RCV (or BI Pharma KG, as
the case may be) at the time of termination,
***                                         
                                                                .
Notwithstanding the foregoing, in the event of termination by VIDARA under
Section 13.2.3, Section 13.2.3 shall govern rather than this Section 13.3.1.

13.3.2 In the event of any termination or expiration of this AGREEMENT, at the
request of VIDARA, BI RCV shall either (i) destroy all material, including but
not limited to samples and all documentation received from VIDARA under this
AGREEMENT, the ORIGINAL SUPPLY AGREEMENT and the RESTATED SUPPLY AGREEMENT, or
(ii) deliver the same to VIDARA or a party nominated by VIDARA, at VIDARA’s cost
(except in the case of termination by VIDARA for BI RCV’s material breach, in
which case such destruction or delivery shall be at BI RCV’s expense).

13.3.3 BI RCV shall promptly return all of VIDARA’s CONFIDENTIAL INFORMATION (as
well as all CONFIDENTIAL INFORMATION of VIDARA provided to BI RCV under the
ORIGINAL SUPPLY AGREEMENT and the RESTATED SUPPLY AGREEMENT) to VIDARA, except
for a single copy and/or sample of each item for documentation purposes only. BI
RCV’s responsibility to keep and store all other materials provided by VIDARA in
the course of this AGREEMENT shall terminate six (6) months after expiration or
termination of this

 

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AGREEMENT (except as may be otherwise provided in the QUALITY AGREEMENT with
respect to storage of records and batch samples).

13.3.4 VIDARA shall promptly return all of BI RCV’s CONFIDENTIAL INFORMATION (as
well as all CONFIDENTIAL INFORMATION of BI RCV provided to VIDARA under the
ORIGINAL SUPPLY AGREEMENT and the RESTATED SUPPLY AGREEMENT) to BI RCV, except
for a single copy and/or sample for documentation purposes only.

13.3.5 The following provisions shall survive termination of this AGREEMENT:
Sections 3.7.1, 7.1, 7.2, 7.3, 7.4, 7.5, 8, 10, 11, 12, 13.2.3, 13.2.4, 13.3 and
14. In addition, the applicable terms of the QUALITY AGREEMENT with respect to
the storage of records and batch samples for each batch of PRODUCT shall also
survive the termination of this AGREEMENT. Termination of this AGREEMENT shall
not relieve either Party of any liability which accrued hereunder prior to the
effective date of such termination, nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this AGREEMENT, nor prejudice either Party’s right to obtain
performance of any obligation.

14. MISCELLANEOUS

14.1 Performance by Affiliates

The Parties recognize that each Party may perform some or all of its obligations
under this AGREEMENT through one or more of its AFFILIATES, provided, however,
that each Party shall remain responsible for such performance by its AFFILIATES
and shall cause its AFFILIATES to comply with the provisions of this AGREEMENT
in connection with such performance. Each Party hereby expressly waives any
requirement that the other Party exhausts any right, power or remedy, or
proceeds against an AFFILIATE, for any obligation or performance hereunder prior
to proceeding directly against such Party.

14.2 Force Majeure

Neither Party shall be liable for any failure or delay in performance or
non-performance caused by circumstances beyond the reasonable control of such
Party, including but not limited to acts of God, explosion, fire, flood, labor
strike or labor disturbances, sabotage, order or decree of any court or action
of any governmental authority (except where such order, decree or action is a
direct result of BI RCV’s breach of its obligations hereunder), or other causes,
whether similar or dissimilar to those specified which cannot reasonably be
controlled by the Party who failed to perform (each such event, a “FORCE MAJEURE
EVENT”). A Party affected by a FORCE MAJEURE EVENT shall give notice of such to
the other Party as soon as is reasonably possible, and shall resume performance
hereunder as soon as is reasonably possible. Each Party shall have the right to
terminate this AGREEMENT in the event that a FORCE MAJEURE EVENT continues for
more than thirty (30) business days upon written notice thereof.

14.3 Assignment

14.3.1 Except as expressly provided for herein neither this AGREEMENT nor any
rights or obligations hereunder may be assigned by either Party without the
other Party’s prior written consent (not to be unreasonably withheld or
delayed), except that either Party may (a) assign its

 

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rights and obligations under this Agreement to any of its AFFILIATES, or
(b) assign this AGREEMENT in its entirety to its sucessor to all or
substantially all of its business or assets to which this AGREEMENT relates,
unless such successor does not have the financial resources to perform such
Party’s obligations under this AGREEMENT in the reasonable judgment of the other
Party by submitting pertinent financial information to such other Party. In the
event of (b) above, BI RCV reserves the right to terminate the AGREEMENT in the
event that such successor is a direct competitor to BI RCV in the field of
contract manufacturing of biopharmaceuticals by means of yeast or microbial
fermentation. In case of an assignment, the assigning party shall immediately
notify the other Party about the intended or executed assignment, as applicable,
and the assignee. Any subsequent assignee or transferee shall be bound by the
terms of this AGREEMENT. Any assignment of this AGREEMENT that is not in
conformance with this Section 14.3 shall be null, void and of no legal effect.

14.4 Notices

Any notice required or permitted to be given hereunder by either Party shall be
in writing and shall be (i) delivered personally, (ii) sent by registered mail,
return receipt requested, postage prepaid or (iii) delivered by facsimile and
confirmed by certified or registered mail to the addresses or facsimile numbers
set forth below:

 

If to VIDARA:

VIDARA Therapeutics Research Ltd

Adelaide Chambers, Peter Street, Dublin 8, Ireland

Facsimile: +353 (0) 1449 3250

Attention: VP Business Development

If to BI RCV:

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringer-Gasse 5 – 11

A-1121 Vienna, Republic of Austria

Facsimile: +43 – 1 – 801 05 - 2440

Attention:

VP Business Development & Key Account Mgmt Europe

Biopharmaceuticals, Contract Manufacturing Business

with a copy to:

Boehringer Ingelheim GmbH

Binger Strasse 173

D-55 216 Ingelheim am Rhein

Facsimile: +49 – 61 32 77 – 98 287

Attention: Head of Corporate Legal Biopharmaceuticals

14.5 Dispute Resolution; Governing Law

14.5.1 In the event of any controversy or claim arising out of, relating to or
in connection with any provision of this AGREEMENT, or the rights or obligations
of the Parties hereunder, the Parties first shall try to settle their
differences amicably between themselves by referring the disputed matter to the
Chief Executive Officer of VIDARA and the Managing Director of BI RCV for
discussion and resolution. Either Party may initiate such informal dispute
resolution by sending written notice of the dispute to the other Party, and
within ten (10) days of such notice

 

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the Chief Executive Officer of VIDARA and the Managing Director of BI RCV shall
meet for attempted resolution by good faith negotiations. If such personnel are
unable to resolve such dispute within thirty (30) days of initiating such
negotiations, the controversy or claim will be referred to binding arbitration
as set forth in Section 14.5.2.

14.5.2 Any controversy or claim arising out of, relating to or in connection
with any provision of this AGREEMENT, or the rights or obligations of the
Parties hereunder, and not resolved by executive mediation in accordance with
Section 14.5.1 hereof, shall be referred to and finally settled by binding
arbitration, in accordance with the Rules of Arbitration of the International
Chamber of Commerce in force on the date the demand for arbitration is filed,
which Rules are deemed to be incorporated by reference into this clause. ***
                                         
                                         
                                         
                                                                      
                                         
                                         
                                         
                                         
                                                 
                                         
                                         
                                         
                                         
                                                 
                                         
                                         
                                         
                                         
                                                     
                                         
                                         
                                         
                                         
                                                     
                                         
                                                . The language to be used in the
arbitral proceedings shall be English. The place of arbitration shall be New
York, New York (USA). Any determination by such arbitration shall be final and
conclusively binding. Judgment on the arbitral award may be entered in any court
having jurisdiction thereof. ***                                          
                                                     
                                         
                                         
                                         
                                                 
                                         
                                         
                                         
                                         
                                                 
                                         
                                         
                                         
                                         
                                                 
                                         
                                         
                                         
                                         
                                                  .

14.5.3 This AGREEMENT shall be governed by and construed in accordance with the
laws of the state of New York (USA), without reference to its conflict of law
rules.

14.5.4 The Parties expressly exclude the application of the United Nations
Convention on Contracts for the International Sale of Goods to this AGREEMENT.

14.6 Independent Contractor

Each of the Parties hereto is an independent contractor and nothing herein
contained shall be deemed to constitute the relationship of partners, joint
venture, nor of principal and agent between the Parties hereto. Neither Party
shall have the authority to bind the other Party.

14.7 Waiver

Any delay in enforcing a Party’s rights under this AGREEMENT or any waiver as to
a particular default or other matter shall not constitute a waiver of such
Party’s rights to the future enforcement of its rights under this AGREEMENT,
excepting only as to an express written and signed waiver as to a particular
matter for a particular period of time.

14.8 Severability

 

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If any of the provisions of this AGREEMENT or parts thereof should be or become
invalid, the remaining provisions will not be affected. The Parties shall
undertake to replace the invalid provision or parts thereof by a new provision
which will approximate as closely as possible the intent of the Parties.

14.9 Entire Agreement

This AGREEMENT, the QUALITY AGREEMENT, the TERMINATION AGREEMENT and the
Exhibits set forth the entire agreement between the Parties, and supersede all
previous agreements (including but not limited to the RESTATED SUPPLY
AGREEMENT), negotiation and understanding, written or oral, regarding the
subject matter hereof. This AGREEMENT may be modified or amended only by an
instrument in writing duly executed on behalf of the Parties. For the avoidance
of doubt, this AGREEMENT does not supersede the TERMINATION AGREEMENT entered
into by the Parties on June 6, 2007.

14.10 Headings

The section headings appearing herein are included solely for convenience of
reference and are not intended to affect the interpretation of any provision of
this AGREEMENT.

14.11 Ambiguities

Ambiguities, if any, in this AGREEMENT shall not be strictly construed against
either Party, regardless of which Party is deemed to have drafted the provision
at issue.

14.12 Counterparts

The AGREEMENT may be executed in two or more counterparts, each of which shall
be an original and all of which shall constitute the same document.

14.13 English Language

The English language will govern any interpretation of or dispute in connection
with this AGREEMENT.

 

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IN WITNESS WHEREOF, the Parties hereto have caused this AGREEMENT to be executed
by their duly authorized representatives as of the EFFECTIVE DATE.

 

Vienna, Austria     Dublin, Ireland BOEHRINGER INGELHEIM RCV GMBH & CO KG    
Vidara Therapeutics Research, Ltd. i.V.     By:   /s/ Dr. Monika Henninger    
By:   /s/ David G. Kelly Name:   Dr. Monika Henninger     Name:   David G. Kelly
Title:   VP Business Development & Key Account Management Europe     Title:  
Director & Chief Financial Officer Date:   18 July 2013     Date:   25th July,
2013 ppa.        

 

By:   /s/ Dr. Christian Eckermann Name:   Dr. Christian Eckermann Title:   Vice
President Operations & Chair of Biopharma/Site Austria Date:   22 July 2013

 

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1.

DEFINITIONS

  2   

2.

GENERAL

  6   

3.

MANUFACTURE AND SUPPLY

  7   

4.

PRICES AND PAYMENT

  13   

5.

QUALITY ASSURANCE AND COMPLIANCE WITH LAW

  14   

6.

CO-OPERATION AND CO-ORDINATION BETWEEN THE PARTIES

  17   

7.

INTELLECTUAL PROPERTY AND LICENSES

  18   

8.

COMPLAINTS; ADVERSE EVENTS; RECALLS

  20   

9.

REPRESENTATIONS AND WARRANTIES

  21   

10.

INDEMNIFICATION

  22   

11.

LIMITATIONS ON LIABILITY

  23   

12.

CONFIDENTIALITY

  23   

13.

DURATION AND TERMINATION

  24   

14.

MISCELLANEOUS

  26   

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TABLE OF EXHIBITS

 

Exhibit 1: BBS Specifications

Exhibit 2: Certificate of Analysis (CoA) Exhibit 3: Certificate of Compliance
(CoC) Exhibit 4: DNA sequence of Interferon Gamma 1b Exhibit 5: Manufacturing
Process Exhibit 6: Product Exhibit 7: Project Manager and Project Team Exhibit
8: Product Specification Exhibit 9: Steering Committee

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EXHIBIT 1

BBS SPECIFICATIONS

***

 

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EXHIBIT 2

Certificate of Analysis (COA):

***

 

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Confidential Treatment and filed separately with the Commission.

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EXHIBIT 3

SEE ATTACHED CERTIFICATE OF COMPLIANCE

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EXHIBIT 4

DNA sequence of INTERFERON GAMMA 1b

***

 

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EXHIBIT 5

MANUFACTURING PROCESS

***

 

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Confidential Treatment and filed separately with the Commission.

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EXHIBIT 6

***

 

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EXHIBIT 7

Project Manager and Project Team:

***

 

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EXHIBIT 8

Product Specification

***

 

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Confidential Treatment and filed separately with the Commission.

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EXHIBIT 9

Steering Committee

***

 

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Confidential Treatment and filed separately with the Commission.