Document:

Ex 10(b)(vi) Summary of Director Compensation and Executive Cash Compensation

    EXHIBIT
      10(b)(vi)

    CONCORDE
      CAREER COLLEGES, INC.

    SUMMARY
      OF DIRECTOR COMPENSATION

    AND
      EXECUTIVE CASH COMPENSATION

    

     

    DIRECTOR
      COMPENSATION

     

            
      The following table sets forth current rates of cash compensation for
      non-employee directors. Director compensation rates

    were
      last
      adjusted December 2005. Employee directors do not receive Board
      Compensation.

    

     

    
      	 	
              2005

            	
              2006

            
	
              Annual
                Retainer

            	
              $        
                2,000

            	
              $      
                10,000

            
	
              Board
                Meeting Attendance Fees

            	
                           
                250

            	
                           
                500

            
	 	 	 
	
              Committee
                Chair Annual Retainer (paid quarterly)

            	 	 
	
              Audit
                Committee

            	
              $         
                4,000

            	
              $         
                4,000

            
	
              Compensation
                Committee

            	
               
                -0-

            	
                
                -0-

            
	
              Nominating
                & Corporate Governance Committee

            	
                -0-

            	
                
                -0-

            

    

    

     

    EXECUTIVE
      COMPENSATION

    

    The
      following table sets forth the current base salaries provided to the Company’s
      CEO and four most highly compensated executive officers. Salary increases are
      determined annually.

    

     

    
      	
                                              
                Executive Officer

            	 	
                           
                Current Salary

            
	
                                              
                Jack L. Brozman

            	 	
                                
                $292,500

            
	
                                              
                Patrick J. Debold

            	 	
                                
                $185,000

            
	
                                              
                Paul R. Gardner

            	 	
                                
                $155,000

            
	
                                              
                Diana D. Hawkins-Jenks

            	 	
                                
                $155,000

            
	
                                              
                Asa E. Johnson

            	 	
                                
                $140,000

            
	 	 	 

    

    

    Executive
      officers are also eligible to receive a bonus each year under a bonus plan
      approved by the Compensation Committee. The award formula for bonuses is based
      upon the Company’s operating income performance for the award period. The
      Company did not achieve the minimum level of operating profit set by the
      Compensation Committee during 2005. The Company did not pay any bonus to an
      Executive Officer for 2005.

     

     

     

    
      
        Part
          IV - Page 4exv10w99

 

Exhibit 10.99

certain material (indicated by an asterisk) has been omitted from this document pursuant to a request for
confidential treatment. the omitted material has been filed
separately with the securities and exchange commission.

DATA TRANSFER, CLINICAL TRIAL

AND MARKET SUPPLY AGREEMENT

     THIS DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT (the “Agreement”), is made
effective as of the 3rd day of November, 2005 (the “Effective Date”) by and between InterMune, Inc.
(“InterMune”), a California corporation, having an address at 3280 Bayshore Boulevard, Brisbane,
California 94005, USA, and Boehringer Ingelheim Austria GmbH (“BI Austria”), an Austrian
corporation, having its registered office at Dr. Boehringer-Gasse 5 — 11, A-1121 Vienna, Republic
of Austria. InterMune and BI Austria may be referred to herein each individually as a “Party” and
jointly as the “Parties.”

     WHEREAS, InterMune holds an exclusive license from Amgen Inc., a company organized
under the laws of Delaware (“Amgen”), to use and commercialize interferon alfacon-1 (“INTERFERON
ALFACON-1”, as further described herein) products in the USA and certain other territories.
INTERFERON ALFACON-1 is approved by the FDA for the indication chronic hepatitis C virus (HCV)
infection, and is sold in the USA under the trade-mark INFERGENâ, and InterMune
intends to seek approval for additional dosing registrations and/or additional indications; and

     WHEREAS, Amgen is currently InterMune’s exclusive manufacturer of INTERFERON ALFACON-1 and in
December 2004, Amgen and InterMune have amended their licensing agreement to allow InterMune to
transfer the manufacturing of INTERFERON ALFACON-1 to a new supplier; and

     WHEREAS, BI Austria and its affiliate Boehringer Ingelheim Pharma GmbH & Co. KG own
facilities specialized for cGMP manufacture of biopharmaceuticals and employ personnel who have
experience in the production, quality control as well as in the registration of biopharmaceuticals;
and

     WHEREAS, InterMune wishes BI Austria, and BI Austria agrees, to provide the SERVICES (as
defined in this Agreement) for the transfer of the manufacturing process of INTERFERON ALFACON-1
from Amgen to BI Austria; and

     WHEREAS, InterMune wishes BI Austria, and BI Austria agrees, to manufacture and
supply InterMune with finished INTERFERON ALFACON-1 product for its conduct of clinical trials and
supply of market needs in accordance with the terms and conditions of this Agreement upon the
completion of the manufacturing transfer from Amgen to BI Austria; and

     WHEREAS, InterMune and BI Austria have entered into a Side Letter Agreement Re
Infergen Manufacturing Transfer dated May 9, 2005 in anticipation of this Agreement, which Side
Letter Agreement shall be incorporated by reference herein.

     NOW, THEREFORE, in consideration of the foregoing recitals which are hereby
incorporated by reference herein and for good and valuable consideration, the receipt and
sufficiency of which hereby acknowledged and agreed upon, the Parties hereto agree as
follows:

1.

 

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 AMGEN PRODUCT means the formulation of INTERFERON ALFACON-1 manufactured in the US by Amgen for
sale under the trademark INFERGEN® and approved by the FDA for the treatment of chronic
hepatitis C virus (HCV) infection.

1.3 AMGEN TECHNOLOGY means all INFORMATION relating to the manufacture, use or sale of INTERFERON
ALFACON-1 that is licensed to InterMune pursuant to that certain License and Commercialization
Agreement dated June 15, 2001, as amended, by and between InterMune and Amgen, including without
limitation the Manufacturing Process as defined in the SIDE LETTER AGREEMENT, and all patents and
patent applications covering such INFORMATION.

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

1.5 BI AUSTRIA’S IMPROVEMENTS shall mean any improvements to the Manufacturing Process as defined
in the SIDE LETTER AGREEMENT or to INTERMUNE TECHNOLOGY conceived, created or discovered (or
reduced to practice) solely by BI Austria under this Agreement or during the period of time from
February 1, 2005 to the Effective Date, either individually or in conjunction with one or more
third parties or BI Austria AFFILIATES, including all patent and patent applications covering any
of the foregoing.

1.6 BI AUSTRIA’S TECHNOLOGY means all INFORMATION in the field of manufacturing and testing of
biopharmaceuticals, including all patents and patent applications covering any of the foregoing,
that are owned or CONTROLLED by BI Austria or BI Pharma at any time prior to the Effective Date of
this Agreement or during the term of this Agreement and that are related to or useful in BI
Austria’s carrying out its obligations under this Agreement, but specifically excluding INTERMUNE’S
TECHNOLOGY, AMGEN TECHNOLOGY and BI AUSTRIA’S IMPROVEMENTS.

1.7 BI PHARMA means BI Austria’s AFFILIATE Boehringer Ingelheim Pharma GmbH & Co. KG.

1.8 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.

2.

 

1.9 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 (a) the U.S. Federal Food, Drug and Cosmetics Act as
amended (21 USC 301 et seq.), (b) relevant U.S. regulations found in Title 21 of
the U.S. Code of Federal Regulations (including but not limited to Parts 11, 210, 211, 600 and
611), (c) EEC Directive 91/356/EEC of 13 June 1991, and (d) the EC Guide to Good Manufacturing
Practice for Medicinal Durg Products, including respective guidance documents and any comparable
laws, rules or regulations of any agreed upon foreign jurisdiction, as each may be amended from
time to time. cGMP also includes adherence to any applicable DRUG PRODUCT license requirements, to
the current requirements of the United States Pharmacopoeia/National Formulary, the current
requirements of the European Pharmacopoeia and the relevant current International Conference on
Harmonization (ICH) guidance documents, including without limitation the ICH Guidance Q7A Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

1.10 CMC means the chemistry, manufacturing, and controls content of a submission to a HEALTH
AUTHORITY.

1.11 COA means the Certificate of Analysis prepared for the DRUG PRODUCT, listing testing
parameters, specifications and test results (in a format and detail as listed in Exhibit 2).

1.12 COC means a Certificate of Compliance prepared for the DRUG PRODUCT confirming compliance with
cGMP regulations and signed by BI Austria’s authorized Qualified Person and the Head of Quality
Management (in a format and such detail to be agreed upon by the Parties).

1.13 CONFIDENTIAL INFORMATION means any proprietary INFORMATION (a) disclosed by one Party to the
other Party (including without limitation, such INFORMATION as was disclosed under the Confidential
Non-Disclosure Agreement dated February 17, 2005, among InterMune, Amgen and BI Austria), 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 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.

1.14 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.

1.15 DRUG PRODUCT shall mean a finished product manufactured by BI Austria and BI Pharma hereunder
and consisting of formulated INTERFERON ALFACON-1 filled into the designated containers for
clinical supply and for market supply, as described in Exhibit 5, or shall mean a finished product
manufactured by BI Austria and BI Pharma hereunder and

3.

 

consisting of formulation buffer filled into the designated containers for clinical supply
(placebo).

1.16 DRUG SUBSTANCE means the purified unformulated bulk form of INTERFERON ALFACON-1.

1.17 DRUG SUBSTANCE SPECIFICATIONS mean the specifications for DRUG SUBSTANCE listed in Exhibit 1.

1.18 EURO means the basic unit of currency among participating European Union countries.

1.19 FDA means the United States Food and Drug Administration and any successor agency thereto
responsible for registration of medicines in the US.

1.20 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.

1.21 FINAL RELEASE means the release of DRUG SUBSTANCE or DRUG PRODUCT by InterMune for use in
clinical trials or for market supply, as applicable, in accordance with InterMune’s respective
SOPs. FINAL RELEASE signifies that the material has been produced using approved processes, in
compliance with appropriate regulations, and meets the established specifications, as determined by
InterMune’s review of all appropriate documentation.

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

1.23 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.

1.24 INTERFERON ALFACON-1 means the recombinant, bio-optimized, non-naturally occurring type-1
interferon alpha that is the active ingredient in INFERGENÒ. The relevant amino
acid sequence is set forth in Exhibit 3.

1.25 INTERMUNE’S TECHNOLOGY means all INFORMATION that is CONTROLLED by INTERMUNE at any time prior
to the Effective Date of this Agreement or

4.

 

during the term of this Agreement that is related to or useful in BI Austria’s manufacture of DRUG
PRODUCT hereunder, and all patents and patent applications covering any of the foregoing; provided
that “INTERMUNE’S TECHNOLOGY” shall not include any BI AUSTRIA’S TECHNOLOGY, BI AUSTRIA’S
IMPROVEMENTS or the AMGEN TECHNOLOGY.

1.26 MCB means the original Master Cell Bank derived from the [***]

1.27 MANUFACTURING PROCESS means the process for fermentation, purification and filling of DRUG
SUBSTANCE and DRUG PRODUCT, as described in Exhibit 4 which process is a combination of the
Manufacturing Process as defined in the SIDE LETTER AGREEMENT with the BI AUSTRIA’S IMPROVEMENTS to
such Manufacturing Process. For purposes of illustration, Exhibit 4 sets forth an initial draft of
a chart comparing the Manufacturing Process as defined in the SIDE LETTER AGREEMENT and the
MANUFACTURING PROCESS, which draft is subject to modifications determined by the PROJECT TEAM.

1.28 MATERIAL SUPPLY BREACH means a failure of BI Austria: (a) to supply to InterMune at least
[***] [***] of InterMune’s binding forecasted requirements of DRUG PRODUCT (or actual orders, if
less) that are due for delivery by the designated delivery date during the then-current calendar
quarter and such failure occurs for [***] consecutive calendar [***]; or (b) to repeatedly ([***]
[***] [***] materially violate against cGMP, as described in Sections 5.6 and 5.7.

1.29 OTHER SERVICES means any non-routine services and performances of work by BI Austria for
InterMune hereunder, which services and work (and the scope, costs and timeline therefor) BI
Austria and InterMune both agree to in writing. OTHER SERVICES shall not include the SERVICES or
the manufacturing or supply of DRUG SUBSTANCE or DRUG PRODUCT for InterMune’s clinical or
commercial requirements.

1.30 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 InterMune’s PROJECT MANAGER and the person designated as BI Austria’s PROJECT
MANAGER are listed in Exhibit 6. Either Party may change its own designated PROJECT MANAGER by
providing written notice thereof to the other Party.

1.31 DRUG PRODUCT SPECIFICATIONS mean the specifications for the DRUG PRODUCT as set forth in
Exhibit 7, or as otherwise agreed by the Parties in writing.

1.32 PROJECT TEAM means the team as listed in Exhibit 6 and described in Section 6.1.

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

5.

 

1.33 QUALITY AGREEMENT means that quality agreement to be entered into by the Parties hereto in
accordance with Section 3.9 hereof, which agreement will (i) define the obligations of BI Austria
and InterMune with respect to the manufacture, testing, storage and delivery of the DRUG PRODUCT to
InterMune, (ii) define the quality requirements placed upon BI Austria with respect to the
manufacture, testing and delivery of DRUG PRODUCT and (iii) form an integral part of this Agreement
once such quality agreement is entered into by the Parties. In the event of any conflict between
Sections 1.8-1.12 and Section 5 of this Agreement and such Quality Agreement, the Quality Agreement
shall control except to the limited extent that a provision of such Quality Agreement expressly and
specifically states an intent of those Sections of this Agreement to supercede.

1.34 QUALITY REQUIREMENTS FOR MANUFACTURING TRANSFER mean InterMune’s quality requirements for
manufacturing transfer as set forth in Exhibit 8, as may be amended from time to time by written
agreement of the Parties.

1.35 MANUFACTURER’S RELEASE means the release of the DRUG PRODUCT by BI Austria to InterMune or its
designee.

1.36 SERVICES mean the services to be performed by BI Austria and BI Pharma in connection with (a)
conducting the necessary activities for the transfer of the manufacturing process of INTERFERON
ALFACON-1 from Amgen to BI Austria, including, but not limited to, carrying out manufacturing
transfer and implementation runs and performing those technical adaptations required to fit the
manufacturing process to BI Austria and BI Pharma facilities, (b) carry out conformance /
qualification runs for the cGMP manufacture of finished INTERFERON ALFACON-1 product; (c) transfer
of analytical methods for the testing and release of buffers, intermediates, drug substance and
drug product to monitor production and release of material; (d) perform method, cleaning and
process validation; (e) conduct stability testing for cell banks, inclusion bodies, intermediate
pools, drug substance, reference material, buffers, etc.; (f) conduct an analytical comparison of
the AMGEN PRODUCT and the DRUG PRODUCT in order to show comparability between the two; and (g)
provide support in writing the amendment to the CMC filing and prepare for FDA inspection in order
for BI Austria to be registered with the FDA as a cGMP-compliant manufacturer for an INTERFERON
ALFACON-1 product to be sold under the INFERGEN® trademark for the US market and other
territories controlled by InterMune, as further described in Exhibit 9 and subject to Section 2.2.
Exhibit 9 also includes the total cost for the SERVICES. The timeline within which BI Austria and
BI Pharma intend to perform the SERVICES is described in Exhibit 10 which may be modified from time
to time as determined by the PROJECT TEAM.

1.37 SIDE LETTER AGREEMENT means that certain Side Letter Agreement Re Infergen Manufacturing
Transfer dated May 9, 2005 entered into between InterMune and BI Austria.

1.38 STEERING COMMITTEE means the committee as listed in Exhibit 11 and as further described in
Section 6.2.

1.39 TERRITORY means (i) the US, Canada, the possessions and territories of each such country and
(ii) Switzerland and those territories that are members of the European Union and/or European
Economic Area as of the Effective Date hereof, all to the extent InterMune has

6.

 

or may acquire the right to manufacture, use or sell INTERFERON ALFACON-1 products during the term
of this Agreement.

1.40 US means the United States of America.

2. Data Transfer and Product Comparison

2.1 InterMune’s Tasks and Responsibilities

     2.1.1 Documentation

     InterMune shall provide (or cause Amgen to provide) BI Austria with the relevant documentation
that is reasonably available to InterMune concerning the AMGEN PRODUCT and its manufacture by
Amgen, including amendments and currently used batch records and testing procedures and all
material correspondence with the HEALTH AUTHORITIES in the US as listed in Exhibit 12. The Parties
acknowledge that BI Austria is already in receipt of most of the relevant documentation.

     2.1.2 Material

     InterMune shall provide (or cause Amgen to provide) BI Austria with original [***] vials from
Amgen and samples of DRUG SUBSTANCE manufactured by Amgen, as well as of the final labeled product
INFERGENâ, in such reasonable amounts and at such times as agreed by the PROJECT
TEAM. InterMune shall also supply BI Austria, as reasonably requested and in reasonable amounts,
with reference material, antibodies and reagents for analytical testing, and all other material
reasonably available to InterMune and reasonably requested by BI Austria that may be suitable as a
basis for comparison between the AMGEN PRODUCT and the DRUG PRODUCT.

     2.1.3 Data

     InterMune shall also provide (or cause Amgen to provide) to BI Austria, as reasonably
requested, all technical data and equipment specifications reasonably available to InterMune that
are used in the manufacture of the AMGEN PRODUCT in the US.

     2.1.4 Support

     InterMune shall (or cause Amgen to) timely send all documentation and materials, and otherwise
timely provide all information and other assistance, reasonably requested by BI Austria for use
under this Agreement. InterMune shall provide such reasonable technical support at its own expense,
which support shall include access to InterMune’s expert personnel upon reasonable notice and at
such reasonable times as the Parties may agree.

     2.1.5 Contact with HEALTH AUTHORITIES

          2.1.5.1 InterMune, as the license holder for the AMGEN 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

7.

 

AUTHORITIES, such as any amendments to the BLA for the AMGEN PRODUCT. BI Austria shall support
InterMune in all matters regarding the manufacturing and quality control of DRUG PRODUCT as
reasonably requested by InterMune, but InterMune shall be the leading Party, responsible for
co-ordination of all regulatory matters.

          2.1.5.2 InterMune will notify BI Austria in advance of any meeting with any HEALTH AUTHORITIES
with regard to manufacture, supply and quality control of the DRUG PRODUCT manufactured by BI
Austria or BI Pharma under this Agreement. Where reasonably possible, InterMune will notify BI
Austria at least five (5) business days in advance of such meeting; provided, however that the
Parties understand and agree that InterMune will not always be able to notify BI Austria of a
meeting with HEALTH AUTHORITIES within the aforementioned five (5) business day period because the
HEALTH AUTHORITIES may not always schedule such meeting far enough in advance so as to allow
InterMune to notify BI Austria within such five (5) business day period. Nonetheless, InterMune
will promptly notify BI Austria as soon as any such meeting with the HEALTH AUTHORITIES is
scheduled. BI Austria shall have the right to participate in such meetings with such HEALTH
AUTHORITIES during the portion of such meetings relating to BI Austria’s or BI Pharma’s
manufacture, supply and quality control of the DRUG PRODUCT.

          2.1.5.3 BI Austria 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 DRUG PRODUCT. InterMune shall submit such report to the HEALTH AUTHORITIES and shall
provide BI Austria with a copy of the finally submitted report.

     2.1.6 Shipment of Material by InterMune

     All material, e.g. samples, sent by InterMune to BI Austria shall be made by shipment from
InterMune’s or Amgen’s facility to BI Austria’s facility in Vienna or BI Pharma’s facility in
Biberach, as appropriate. Shipping costs including insurance will be borne by InterMune, and risk
of loss in transit shall lie with InterMune.

2.2 BI Austria’s Tasks and Responsibilities

     2.2.1 Scope of Services. Subject to this Section 2.2, BI Austria’s tasks and responsibilities
with respect to the performance of the SERVICES are as set forth in Exhibit 9 and the timeline for
the performance of such SERVICES are as set forth in Exhibit 10. To the extent any task or
responsibility of BI Austria is subcontracted to BI Pharma by BI Austria as permitted under this
Agreement, BI Austria shall be responsible for BI Pharma’s performance thereof.

     2.2.2 Comparison of Documentation and Materials

          2.2.2.1 As a part of the SERVICES, BI Austria shall evaluate and compare all documentation and
other materials relating to the manufacture and testing of the AMGEN PRODUCT with all relevant
documentation and other materials relating to the manufacture and testing of the DRUG PRODUCT that
is necessary to demonstrate comparability between such Amgen documentation, as listed in Exhibit
12, and such BI Austria documentation.

8.

 

          2.2.2.2 As a part of the SERVICES, BI Austria shall also carry out an analytical comparison of
the DRUG PRODUCT and DRUG SUBSTANCE with the AMGEN PRODUCT based on a mutually agreed protocol.

     2.2.3 Production Runs

     As a part of the SERVICES and subject to Section 2.2.4, BI Austria shall carry out the
necessary number of production runs of DRUG PRODUCT in order to obtain APPROVAL in the US as a cGMP
manufacturer of DRUG SUBSTANCE (known as “conformance batches” or “conformance lots”), and to have
BI Pharma obtain APPROVAL in the US as a cGMP manufacturer of DRUG PRODUCT. DRUG SUBSTANCE and DRUG
PRODUCT derived from these runs shall be used for evidencing comparability between the AMGEN
PRODUCT and the DRUG PRODUCT. The Parties anticipate that at least three (3) such production runs
will be necessary for such purposes. For such production runs, BI Austria shall provide to
InterMune access to or copies of those QUALITY REQUIREMENTS FOR MANUFACTURING TRANSFERS listed in
Exhibit 8.

     2.2.4 Additional Runs

     If any HEALTH AUTHORITIES request further analytical testing and/or production runs in
addition to those described in Exhibit 9, BI Austria shall perform such testing and/or production
runs as requested by InterMune and the Parties will negotiate in good faith the cost and
responsibility for such non-foreseeable additional activities.

     2.2.5 Additional Documentation

     If any HEALTH AUTHORITIES request that InterMune or BI Austria provide, in connection with BI
Austria’s and/or BI Pharma’s receipt of approval as a manufacturer of DRUG PRODUCT hereunder,
further documentation regarding the manufacture of DRUG PRODUCT in addition to the documentation as
foreseen under the SERVICES set forth in Exhibit 9 (e.g. certain reports), BI Austria will provide
such additional documentation to InterMune for provision to such HEALTH AUTHORITIES as soon as
reasonably possible and the Parties will negotiate in good faith the cost and responsibility for
the provision of such additional documentation. Such additional documentation may be either (a)
product and/or process-related or (b) facility-related (e.g. infrastructure, utilities, personnel,
training etc.).

     2.2.6 Regulatory Support

          2.2.6.1 As a part of the SERVICES, BI Austria shall provide all site-relevant documentation (both
from itself and from BI Pharma) and all data relevant for compiling the CMC section necessary for
InterMune’s drafting of the BLA supplement required by the FDA due to the change of manufacturer
for the AMGEN PRODUCT. BI Austria agrees to use commercially reasonable efforts and fully
co-operate with InterMune in obtaining and

9.

 

maintaining all US governmental approvals and registrations relevant to the CMC section of the
registration dossier (and their foreign equivalents) as requested by InterMune.

          2.2.6.2 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 DRUG PRODUCT
registration with the HEALTH AUTHORITIES so that BI Austria shall be able to fulfill its
obligations under this Agreement with respect to the CMC portion of such DRUG PRODUCT registration.
Any regulatory filings which contain any BI Austria data shall be subject to BI Austria’s review
and written approval prior to submission to the HEALTH AUTHORITIES (which approval shall not be
unreasonably withheld or delayed).

     2.2.7 Format and Content of Documents

     BI Austria’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).

     2.2.8 Standard of Performance

     BI Austria shall diligently perform the SERVICES, and shall ensure that BI Pharma diligently
performs the SERVICES, in a manner consistent with good scientific / regulatory / business
practices. InterMune acknowledges that the SERVICES are of biological nature and therefore neither
success nor commercial exploitability can be guaranteed by BI Austria.

3. Manufacture and Supply

3.1 General

     3.1.1 [***] for use and commercialization in the TERRITORY, DRUG SUBSTANCE or DRUG PRODUCT for
use in the treatment or prevention of any human disease or condition. BI Austria shall not supply
DRUG SUBSTANCE or DRUG PRODUCT for use in the treatment of any human disease or condition to any
third party for use and/or sale in the TERRITORY without InterMune’s prior written consent. [***]
all of InterMune’s clinical trial supply, and from the time BI Austria and BI Pharma are approved
by the HEALTH AUTHORITIES also [***] for the term of this Agreement, subject to Section 3.7.

     3.1.2 All DRUG SUBSTANCE manufactured by BI Austria hereunder, and all DRUG PRODUCT
manufactured and supplied to InterMune by BI Austria hereunder, shall be manufactured and supplied
in accordance with the DRUG SUBSTANCE SPECIFICATIONS and DRUG PRODUCT SPECIFICATIONS, the cGMP
requirements and all applicable laws, regulations and ordinances of the jurisdiction in which such
manufacture occurs.

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

10.

 

     3.1.3 BI Austria shall manufacture DRUG SUBSTANCE according to the DRUG SUBSTANCE
SPECIFICATIONS. BI Austria shall manufacture DRUG PRODUCT according to DRUG PRODUCT SPECIFICATIONS
for clinical supply. Upon receipt of FDA APPROVAL of BI Austria’s facility as well as BI Pharma’s
facility, BI Austria shall also manufacture DRUG PRODUCT for market supply. DRUG SUBSTANCE for
clinical and market supply shall be manufactured at BI Austria and transferred to BI Pharma for
filling of vials and/or syringes. Manufacturing and filling of vials and/or syringes as well as
the storing of DRUG PRODUCT shall be in accordance with the DRUG PRODUCT SPECIFICATIONS, the cGMP
requirements and all applicable laws, regulations and ordinances of the jurisdiction in which such
manufacturing and/or filling occurs. Notwithstanding the fact that BI Austria takes BI Pharma as a
toll manufacturer for filling of DRUG PRODUCT, BI Austria takes responsibility for the manufacture
and supply of DRUG PRODUCT to InterMune in accordance with the terms and conditions of this
Agreement.

     3.1.4 Notwithstanding the exclusive arrangement set forth in Section 3.1.1 above, the Parties
acknowledge and agree that there will be an overlapping period of time during which Amgen will be
winding down and completing its manufacturing and supply obligations under the License and
Commercialization Agreement dated June 15, 2001, as amended, by and between Amgen and InterMune and
during which BI Austria will be completing its SERVICES and beginning its manufacturing and supply
obligations under this Agreement. Consequently, BI Austria agrees that during such overlapping
transition time period, Amgen may continue to supply to InterMune any remaining inventory of AMGEN
PRODUCT or DRUG SUBSTANCE manufactured by Amgen for InterMune until Amgen completes its winding
down of its manufacturing and supply activities for InterMune.

     3.1.5 With respect to conformance batches produced as part of the production runs described
under Section 2.2.3, the Parties acknowledge and agree that such conformance batches may be
suitable for use to produce DRUG PRODUCT for commercial supply. Accordingly, the Parties agree
that they will work together in good faith to have BI Austria to use as much of the DRUG SUBSTANCE
resulting from such conformance batches as possible to produce DRUG PRODUCT for supply to InterMune
under this Agreement. If all the DRUG SUBSTANCE from the conformance batches must be destroyed,
the Parties agree that the maximum obligation of InterMune to BI Austria for the destruction of
such DRUG SUBSTANCE is [***]. In the event that less than all of the DRUG SUBSTANCE resulting from
the conformance batches must be destroyed, then the payment obligation by InterMune shall be
reduced on a pro rata basis based on the percentage that is destroyed. For example, if 1/3 of DRUG
SUBSTANCE is destroyed, then the payment obligation by InterMune will be [***].

     3.1.6 Notwithstanding the exclusive arrangement set forth in Section 3.1.1 above, the Parties
acknowledge and agree that InterMune may conduct research feasibility studies for and develop
additional configurations for the DRUG SUBSTANCE other than vials or pre-filled syringes currently
included in the definition of DRUG PRODUCT. In such event, InterMune shall have the right to
purchase from BI Austria and BI Austria shall sell to InterMune DRUG SUBSTANCE. If InterMune
desires to purchase DRUG SUBSTANCE before APPROVAL of BI Austria in the US as a cGMP manufacturer
of DRUG SUBSTANCE, then the price at which BI AUSTRIA will sell such DRUG SUBSTANCE to InterMune
will be negotiated by the Parties

 

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11.

 

in good faith. If InterMune desires to purchase DRUG SUBSTANCE after APPROVAL of BI Austria in the
US as a cGMP manufacturer of DRUG SUBSTANCE, then the price at which BI Austria will sell such DRUG
SUBSTANCE to InterMune will be provided by BI Austria to InterMune as set forth in Exhibit 14.
Should InterMune desire to fill and finish the DRUG SUBSTANCE in such newly developed
configurations for clinical and/or commercial supply, InterMune shall provide written notice to BI
Austria and shall first negotiate exclusively in good faith with BI Austria to have BI Austria fill
and finish in such configurations; provided, however, that in the event the Parties are unable to
reach agreement therefor within ninety (90) days after the aforementioned notice is provided by
InterMune to BI Austria, InterMune shall have the right to fill and finish the DRUG SUBSTANCE in
such newly developed configurations on its own or through a third party for clinical and/or
commercial use.

     3.1.7 The Parties further acknowledge and agree that BI Austria will be required to
subcontract to a third party the radioactive bioassay testing for the DRUG PRODUCT. The Parties
will cooperate with one another and work together in good faith to decide upon the appropriate
third party to conduct such bioassay testing. BI Austria shall assume the responsibility and cost
for such bioassay testing within the framework of the MANUFACTURER’S RELEASE.

3.2 Forecasts

     3.2.1 No later than [***] prior to [***] of DRUG PRODUCT requested by InterMune for clinical
and/or market supply, InterMune shall send to BI Austria a forecast for [***] (which forecast may
commence on the first day of any calendar quarter). After such first forecast is given, InterMune
will update the forecast on a [***] basis at the latest on the first day of each ensuing [***]
[***] during the term of this Agreement. The forecast provided by InterMune shall become binding
no later than [***] prior to the first delivery date of DRUG PRODUCT as follows: The first [***]
of such forecast shall be firm (red zone). For [***] (blue zone) InterMune can reduce its forecast
by [***] but only once in each one (1) of these quarters, and may increase its forecast by [***]
once in each one (1) of these quarters. [***] will constitute a non-binding forecast (green zone).
InterMune agrees to order the DRUG PRODUCT in filling lot quantities or multiples thereof. [***]
Prior to InterMune submitting the first forecast required hereunder, the Parties will mutually
agree upon the final lot size for each of the vials and syringes, which lot size will be within the
applicable range set forth above.

     Following BI Austria’s and BI Pharma’s FDA approval to manufacture DRUG PRODUCT for market supply,
InterMune shall order the requested amounts of DRUG PRODUCT. There
shall be no annual minimum
purchase obligations imposed upon InterMune for the DRUG PRODUCT unless and until results from
InterMune’s daily INFERGEN® Phase III clinical trial (IRHC-0001) (“DIRECT TRIAL”)
becomes available and such results are [***]

 

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12.

 

[***] As of the date hereof, InterMune estimates that the results of the DIRECT TRIAL will be
available in the [***] Within a reasonable amount of time, BI Austria and InterMune shall
cooperate and work together in good faith to commence and conclude negotiations on the annual
minimum and maximum purchase obligations for InterMune and the annual minimum and maximum supply
obligations of BI Austria such that no later than two (2) years prior to the estimated time for BI
Austria’s and BI Pharma’s FDA approval to manufacture DRUG PRODUCT for market supply, BI Austria
and InterMune shall have reached agreement on the annual minimum and maximum purchase and supply
obligations of the Parties, which agreement shall be set forth in a separate addendum hereto.

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

     3.2.3 If InterMune reduces the forecast for [***] by an amount in excess of [***] (net of any
increases in actual orders for these [***] [***], then InterMune shall be [***] which was [***] of
[***] [***] at the [***] [***] of the unit price of the DRUG PRODUCT then in effect.

     3.2.4 For planning purposes only, no later than January 31, 2006 InterMune will provide to BI
Austria a non-binding estimate of InterMune’s requirements for the DRUG PRODUCT for the [***]
following the estimated commercial market launch of each such presentation of the DRUG PRODUCT,
which non-binding estimate shall be attached hereto as Exhibit 13.

3.3 Purchase Orders

     3.3.1 All purchases of DRUG PRODUCT hereunder shall be made pursuant to written purchase
orders provided to BI Austria by InterMune. To the extent that the terms of a purchase order of
InterMune or of BI Austria’s or BI Pharma’s “General Conditions of Sale” are inconsistent with the
terms of this Agreement, this Agreement shall prevail.

     3.3.2 BI Austria shall guarantee that at the date of MANUFACTURER’S RELEASE all DRUG PRODUCT
supplied to InterMune shall have a minimum residual shelf life of not less than [***] off the shelf
life of the DRUG PRODUCT in existence at the date of the manufacturing of such DRUG PRODUCT. The
Parties acknowledge and agree that the shelf life at the time of the manufacturing of the DRUG
PRODUCT is dependent on the information on the current expiry of the DRUG PRODUCT.

     3.3.3 BI Austria shall ship all DRUG PRODUCT as set forth in Section 3.4 by the date and in the
quantities specified in the applicable purchase order. BI Austria shall be obligated to accept any
purchase order within the range of permitted variation in the forecasted quantities as

 

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13.

 

set forth in Section 3.2.1. and 3.2.2. Any other purchase order shall be binding on BI Austria only
if it is accepted by BI Austria, which acceptance shall not be unreasonably withheld. If BI Austria
does not accept such a purchase order, then InterMune may use a secondary source manufacturer for
such purchase order in accordance with the procedures set forth in Section 3.7.

     3.3.4 InterMune shall be obligated to buy and BI Austria shall be obligated to sell only the
quantities of DRUG PRODUCT which are subject to a purchase order accepted by BI Austria. Any
purchase order (or portion thereof) for which InterMune has not received a written rejection from
BI Austria within [***] of BI Austria’s receipt of such purchase order shall be deemed accepted by
BI Austria. Without limiting the generality of the foregoing, with respect to DRUG PRODUCTS
ordered by InterMune for its clinical supply requirements, the number of vials or syringes supplied
by BI Austria shall not exceed the number of vials or syringes subject to the applicable purchase
order submitted by InterMune; provided, however, that if the number of vials or syringes BI Austria
is able to supply falls below the number of vials or syringes ordered by InterMune in such purchase
order and such lesser number is within a reasonable range of the number ordered by InterMune, BI
Austria shall notify InterMune in writing and inquire as to whether such lesser number of vials or
syringes is acceptable and if not, whether BI Austria should produce an additional batch of DRUG
SUBSTANCE to produce enough vials or syringes to satisfy InterMune’s purchase order. If InterMune
notifies BI Austria that such lesser number of vials or syringes is acceptable to InterMune, then
the applicable purchase order shall be deemed to be amended to provide for such lesser number of
vials or syringes and BI Austria shall be deemed to have accepted such purchase order in accordance
with Section 3.3. On the other hand, if InterMune notifies BI Austria that BI Austria should
manufacture an additional batch of DRUG SUBSTANCE to produce the number of vials or syringes
ordered by InterMune in its purchase order submitted to BI Austria, then (i) the Parties will
mutually agree upon a reasonable delivery date for such vials or syringes derived from such
additional batch of DRUG SUBSTANCE, (ii) BI Austria shall be obligated to produce the additional
batch of DRUG SUBSTANCE, (iii) InterMune shall be obligated to purchase any excess vials or
syringes of DRUG PRODUCT produced by BI Austria from such additional batch of DRUG SUBSTANCE, (iv)
the purchase order submitted to BI Austria by InterMune shall be deemed amended to account for any
excess vials or syringes resulting from the additional batch of DRUG SUBSTANCE and to account for
the agreed upon delivery date for the vials or syringes derived from such additional batch of DRUG
SUBSTANCE and (v) such purchase order shall be deemed accepted by BI Austria in accordance with
Section 3.3.

3.4 Shipment of DRUG PRODUCT and Material by BI Austria

     3.4.1 The DRUG PRODUCT and all material (e.g. samples) shall be shipped [***] either BI Pharma’s
facility in Biberach, Germany or BI Austria’s facility in Vienna, Austria, as the case may be, to
InterMune or as directed by InterMune, in accordance with Incoterms 2000 as published by the
International Chamber of Commerce. InterMune’s designated carrier shall be used to ship DRUG
PRODUCT to the site designated by InterMune. The Parties acknowledge and agree that the only
deviation from the definition of “EX WORKS” is that BI Austria shall be responsible and bear the
cost of stowage and loading the DRUG PRODUCT onto the InterMune designated carrier such that the
risk of loss and title shall pass

 

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14.

 

from BI Austria to InterMune only upon completion of the loading by BI Austria of the DRUG PRODUCT
onto the InterMune designated carrier. Risk of loss in transit by InterMune’s designated contract
carrier shall lie with InterMune, except where such loss is caused by BI Austria’s or BI Pharma’s
negligence.

     3.4.2 BI Austria will provide or will have provided assistance to InterMune regarding
necessary procedures for exportation and/or importation of DRUG PRODUCT. BI Austria shall also
provide to InterMune every two (2) months the shipping schedule for the DRUG PRODUCT.

     3.4.3 In the event that DRUG PRODUCT, which has been ordered by InterMune pursuant to a
purchase order is not shipped to InterMune within [***] calendar days of FINAL RELEASE for reasons
solely and directly assignable to InterMune (e.g., lack of shipping instructions, etc.), the risk
of the deterioration or perishing of the DRUG PRODUCT resulting therefrom passes to InterMune. BI
Austria shall render invoice and InterMune shall pay for such DRUG PRODUCT when the invoice becomes
due. BI Austria shall be entitle to claim reimbursement for commercially reasonable storage costs
incurred by BI Austria after expiry of the [***] calendar day time limit. In the circumstances
where InterMune has paid for the DRUG PRODUCT but such DRUG PRODUCT is not available for shipment
(e.g., analytical testing issues, regulatory filing issues), the Parties will cooperate with one
another in good faith and mutually agree with one another on the appropriate allocation between the
Parties of risk of deterioration or perishing of the DRUG PRODUCT.

3.5 Testing and Rejection

     3.5.1 Within [***] business days of its receipt of DRUG PRODUCT at such destination as may be
designated by InterMune, InterMune may perform such tests and samplings as are appropriate to
determine whether such DRUG PRODUCT meets the applicable DRUG PRODUCT SPECIFICATIONS. If InterMune
refuses acceptance of DRUG PRODUCT, then InterMune shall inform BI Austria in writing within [***]
further business days of any aspect in which such DRUG PRODUCT fails to conform to the DRUG PRODUCT
SPECIFICATIONS. If BI Austria does not receive such a notice within [***] business days of
InterMune’s receipt of such DRUG PRODUCT, then InterMune shall be deemed to have accepted the DRUG
PRODUCT; provided that InterMune shall have the right to revoke its acceptance of such goods if it
later discovers latent defects. A latent defect is a deviation which constitutes a breach of one
or more of BI Austria’s warranties pursuant to Sec. 9.2.1 through 9.2.5 of this Agreement, which
was not reasonably discoverable at the time of receipt and the cause of which is assignable solely
to BI Austria (or BI Pharma).

     3.5.2 If BI Austria receives a notice from InterMune pursuant to Section 3.5.1 that InterMune
does not accept any DRUG PRODUCT supplied hereunder, then BI Austria shall immediately start
re-testing the DRUG 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 Austria agrees with InterMune’s rejection of such DRUG PRODUCT,
if requested in writing by InterMune, BI Austria shall use reasonable efforts

 

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15.

 

to promptly replace such allegedly defective DRUG PRODUCT, the costs of which shall be borne as set
forth in Section 3.5.4.

     3.5.4 In the event that BI Austria’s re-testing does not verify InterMune’s reasons for
rejecting such DRUG PRODUCT, the Parties shall mutually agree on an independent laboratory that
shall determine by applying validated product-specific analytical methods whether such DRUG PRODUCT
meets the DRUG PRODUCT SPECIFICATIONS. The conclusions of this independent laboratory shall be
binding upon both Parties. If such laboratory determines that such DRUG PRODUCT does meet the DRUG
PRODUCT SPECIFICATIONS, then InterMune shall [***]. If such laboratory determines that such DRUG
PRODUCT does not meet the DRUG PRODUCT SPECIFICATIONS, then BI Austria shall [***]

     3.5.5 Neither Party may destroy any DRUG PRODUCT alleged not to meet the DRUG PRODUCT
SPECIFICATIONS until the independent laboratory determines whether such DRUG PRODUCT meets the
applicable DRUG PRODUCT SPECIFICATIONS and provides written notification to the Parties with
respect to such determination, unless BI Austria accepts InterMune’s basis for such rejection.
Thereafter, BI Austria shall have the obligation to destroy or have destroyed, at its cost, all
such rejected DRUG PRODUCT. Upon BI Austria’s written request and at BI Austria’s cost, InterMune
shall either destroy or return to BI Austria any rejected DRUG PRODUCT. The Parties agree that in
the event of destruction of DRUG 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 DRUG PRODUCT (other than claims that
such DRUG PRODUCT does not meet the DRUG PRODUCT SPECIFICATIONS and latent defects not reasonably
detectable upon inspection) will be dispatched by InterMune in writing within [***] business days
following receipt thereof. BI Austria shall use reasonable efforts to replace the quantity of goods
which such claims apply, which replacement shall be at InterMune’s expense unless such claims are
due to the negligence of BI Austria.

3.6 Increase of Manufacturing Capacity

     3.6.1 As set forth in Section 3.2.1, the Parties will agree upon the annual minimum and
maximum supply obligations of BI Austria no later than two (2) years prior to the estimated time
for BI Austria’s and BI Pharma’s FDA approval to manufacture DRUG PRODUCT for market supply, which
supply capacity obligations shall be set forth in a separate addendum hereto. After the annual
minimum and maximum purchase and supply obligations of the Parties are agreed upon, should it
become at any time apparent that a higher DRUG PRODUCT demand is necessary, InterMune will notify
BI Austria thereof. BI Austria shall inform as soon as reasonably possible InterMune of the
respective costs for guaranteeing the appropriate reserved capacity for manufacturing the amount
exceeding the original amount agreed upon by the Parties. Upon agreement on the costs BI Austria
shall reserve the capacity needed for the increased demand of DRUG PRODUCT.

 

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16.

 

3.7 Second Source Manufacturer

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

     3.7.2 In the event the STEERING COMMITTEE decides that it is appropriate for InterMune to
establish a second source manufacturer, InterMune agrees to provide the first opportunity to
qualify as a second source manufacturer for PRODUCT to a BI Austria AFFILIATE. If such an AFFILIATE
is — as foreseeable — unable to supply InterMune’s DRUG PRODUCT requirements then InterMune shall
be free to choose an alternate supplier. In this case BI Austria shall assist InterMune 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 InterMune’s cost.

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

3.8 MATERIAL SUPPLY BREACH

     3.8.1 In the event of a MATERIAL SUPPLY BREACH, InterMune shall provide BI Austria written
notification of such MATERIAL SUPPLY BREACH. Upon BI Austria’s receipt of such notice, the Parties
will promptly (but in no event any later than [***] business days from the date of InterMune’s
notice to BI Austria of the MATERIAL SUPPLY BREACH) agree upon a timetable (not to exceed [***]
months) and activity plan pursuant to which BI Austria will cure such MATERIAL SUPPLY BREACH. In
the event that the Parties are unable to agree upon a timetable and
activity plan within the
aforementioned [***] business day period after good faith discussions and negotiations, InterMune
shall [***]. In the event the Parties do agree upon a timetable and activity plan and BI Austria
fails to cure such MATERIAL SUPPLY BREACH within the agreed upon timetable and activity plan,
InterMune shall have the right to [***].

 

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17.

 

     In the event, that

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

     (ii) in the event such a BI Austria AFFILIATE is — as foreseeable — unable to supply
InterMune’s DRUG PRODUCT requirements and

     (iii) provided that DRUG PRODUCT supply as requested by InterMune by a different second source
manufacturer, a company experienced in manufacturing of biopharmaceuticals derived from [***] and
selected by InterMune could demonstrably take place earlier than a MATERIAL SUPPLY BREACH by BI
Austria could be remedied, BI Austria shall assist InterMune as requested in [***] [***]

     3.8.2 In the event that BI Austria reasonably anticipates that there is a substantial
likelihood that a MATERIAL SUPPLY BREACH will occur, BI Austria shall promptly notify InterMune 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 Austria could take to avoid such MATERIAL
SUPPLY BREACH. If InterMune is not reasonably satisfied that BI Austria will be able to avoid such
MATERIAL SUPPLY BREACH, then InterMune 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 3.7.

3.9 Quality Agreement

     Promptly after the Effective Date, the Parties shall enter into good faith negotiations for an
appropriate Quality Agreement which shall be in final form and executed by the Parties not later
than one hundred fifty (150) calendar days after the Effective Date. Such Quality Agreement shall
contain such terms and conditions as are customary for the manufacture of pharmaceutical products,
including but no limited to storage of records, retention of samples and the like.

4. Prices and Payment

     4.1 The prices to be paid by InterMune for the SERVICES and DRUG PRODUCT/DRUG SUBSTANCE provided
hereunder have been agreed to by the Parties and are listed in Exhibit 9

 

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18.

 

and Exhibit 14, respectively. The Parties acknowledge and agree that as of the Effective Date
hereof, InterMune has paid to BI Austria and BI Austria has received from InterMune an amount equal
to [***]. In addition, upon execution of this Agreement, InterMune shall pay to BI Austria an
amount equal to 12,080,000 Euros. The [***] and 12,080,000 Euro payments result from [***].

     The price for the DRUG PRODUCT will be adjusted year by year in accordance with the average of
[***] Payments by InterMune to BI Austria hereunder shall be in Euros; provided, however, that on
each invoice, the applicable exchange rate to convert Euros to US Dollars as of the invoice date
shall be noted. [***].

4.2 [Intentionally omitted.]

4.3 The price for any services constituting OTHER SERVICES hereunder will be agreed upon by the
Parties at the time the Parties agree on the scope of such OTHER SERVICES. For accounting
purposes, BI Austria may render an invoice to InterMune for any such OTHER SERVICES which are part
of an overall work package (work in progress) performed and completed (discrete and definable
sub-packages) as of the December 31st of each year during the term of this Agreement,
even if the overall work package to which such services or performances apply, has not yet fully
been completed.

4.4 The price for the SERVICES, OTHER SERVICES and purchase price for DRUG PRODUCT shall be paid to
BI Austria no later than [***] [***] after the date that BI Austria’s invoice is received by
InterMune.

     4.4.1 Payment of the invoice amounts shall be made in Austria, [***] into an account with such
Austrian credit institution as shall be notified by BI Austria to InterMune from time to time.

     4.4.2 All payments owed to BI Austria by InterMune on the basis of accounts rendered shall be
made in such a way that [***] shall be [***] that are [***] on such invoice amounts (e.g. customs
duties, VAT, but specifically excluding income taxes). 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 Austria reserves the right to claim any damage exceeding such amount that shall have
been caused by such delay, subject to Section 11.1.

 

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19.

 

5. Quality Assurance and compliance with law 

5.1 RELEASE of Product

     5.1.1 BI Austria shall be responsible for the MANUFACTURER’S RELEASE of DRUG PRODUCT according
to the DRUG PRODUCT SPECIFICATIONS, the cGMP requirements and all applicable Austrian and German
laws. BI Austria shall certify in writing that each shipment lot of DRUG PRODUCT was produced and
tested in compliance with (i) the SPECIFICATIONS, (ii) the cGMP requirements and (iii) all
applicable laws, regulations and ordinances of the jurisdiction in which such manufacture occurs.

     5.1.2 BI Austria shall provide to InterMune, through BI Pharma, such documents similar to the
QUALITY REQUIREMENTS FOR MANUFACTURING TRANSFERS as listed in Exhibit 8 including but not limited
to a COA and COC signed by the appropriate personnel as defined in BI Austria’s Quality Management
System for each shipment lot of DRUG PRODUCT from BI Pharma’s manufacture site in Biberach, Germany
in order to prove BI Austria’s compliance with the Article 5.1.1.

5.2 Storage of Records and Batch Samples

     5.2.1 BI Austria shall maintain in compliance with cGMP standards all batch samples and all
records required by law or as otherwise mutually agreed in writing by the Parties (i.e. batch
records, analytical raw data) necessary to evidence compliance with all its obligations under this
Agreement and relating to the manufacture of the DRUG SUBSTANCE and of DRUG PRODUCT. The
documentation concerning manufacture of DRUG SUBSTANCE shall be stored at BI Austria and concerning
manufacture of DRUG PRODUCT shall be stored in Biberach. Storage of retained samples of DRUG
SUBSTANCE as well as DRUG PRODUCT shall be at BI Austria.

     5.2.2 Copies of all documentation and information relating to the manufacture, processing,
packaging and shipping of DRUG PRODUCT and/or required to support InterMune’s BLA or other
regulatory submissions, including but not limited to information relating to batch records,
methods, equipment and the facility, will be provided by BI Austria to InterMune for review and
inclusion as necessary in InterMune’s regulatory submissions.

     5.2.3 All such records shall be maintained for a period not less than five (5) years from the
date of expiration of each batch of DRUG PRODUCT to which such records pertain, or such longer
period as may be required by local law and the rules or regulations of the FDA or other applicable
HEALTH AUTHORITIES. Following the expiration of such required retention period, prior to the
destruction of any such record, BI Austria shall give written notice thereof to InterMune, and
InterMune shall have the right to request, receive and retain such records with no further
compensation to BI Austria. Samples shall be maintained for such period of time and may be
provided to InterMune as set forth in the Quality Agreement.

20.

 

5.3 Final Release

     FINAL RELEASE of DRUG PRODUCT supplied by BI Austria and/or BI Pharma hereunder for use in
humans shall solely be made by and under the responsibility of InterMune. InterMune may perform
on-site review of DRUG SUBSTANCE specific documentation for FINAL RELEASE of any batch of DRUG
PRODUCT at times to be mutually agreed upon between the Parties in good faith, but in no event
later than [***] calendar days after access is provided to InterMune to MANUFACTURER’S RELEASE
documentation by BI Austria. If InterMune does not perform FINAL RELEASE within the aforementioned
[***] calendar day period, DRUG PRODUCT shall be deemed accepted by InterMune unless InterMune has
communicated with BI Austria about DRUG PRODUCT related issues which could prevent InterMune from
performing the FINAL RELEASE within the aforementioned time period.

5.4 Third Party Services

     Except as specifically provided for herein, BI Austria will not contract out to any third
party any part of the SERVICES or OTHER SERVICES or the manufacture and testing of DRUG SUBSTANCE
or DRUG PRODUCT, without prior written approval from InterMune, which shall not be unreasonably
withheld.

5.5 Consent to Changes

     BI Austria will not make any changes to BI Austria’s, and shall ensure that BI Pharma shall
not make any changes to BI Pharma’s, respective manufacturing facilities, equipment, testing
procedures, validation, suppliers of raw materials and components or documentation systems that are
related to or would have an impact on the DRUG PRODUCT and having a non-trivial impact on the DRUG
PRODUCT, without the prior written consent of InterMune and solely as is permitted by cGMP. In the
event that a supplier of raw material is unable to deliver the respective raw material in time for
scheduled manufacturing BI Austria is free to choose another supplier, provided that such supplier
supplies such raw material that fully meets the respective raw material specification, and subject
to BI Austria’s providing InterMune prior written notice thereof.

5.6 Inspections by HEALTH AUTHORITIES

     5.6.1 BI Austria shall secure that during APPROVAL inspections at BI Austria’s and/or BI
Pharma’s facilities by any applicable HEALTH AUTHORITIES, BI Austria shall give InterMune prior
written notice thereof promptly following BI Austria’s receipt of notice of such inspection, so
that representatives of InterMune may attend and participate in such inspections, for example, to
answer DRUG PRODUCT and clinical trial related questions.

     5.6.2 BI Austria shall advise, and shall ensure that BI Pharma shall advise, InterMune in writing
immediately of any requests by any applicable HEALTH AUTHORITIES for inspections at either of BI
Austria’s or BI Pharma’s facilities, but in any event, no later than [***] business days prior to
the scheduled date of such inspection. Upon reasonable notice, InterMune or its representatives may
attend only such portions of such inspections or audits that deal with DRUG PRODUCT related issues,
due to BI Austria’s other secrecy obligations.

 

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21.

 

Access to such facilities may be subject to reasonable restrictions customarily placed upon
visitors to the site.

     5.6.3 BI Austria also agrees to notify InterMune within [***] business days of any written or
oral inquiries, notifications, or inspection activity by any HEALTH AUTHORITIES (or any third party
authorized by the HEALTH AUTHORITIES) in regard to DRUG PRODUCT. BI Austria shall provide a
reasonable description to InterMune of any such inquiries, notifications or inspections promptly
(but in no event later than [***] business days) after such visit or inquiry. BI Austria shall
furnish to InterMune (a) as soon as possible but in no event more than [***] business days after
receipt, any report or correspondence issued by the HEALTH AUTHORITIES (or a third party authorized
by a HEALTH AUTHORITIES) in connection with such visit or inquiry, including but not limited to,
any FDA Form 483 (List of Inspectional Observations) or warning letter, and (b) not later than
[***] business days prior to the time it provides to a HEALTH AUTHORITY, copies of any and all
proposed written responses or explanations relating to items set forth above (each, a “Proposed
Response”), in each case purged only of trade secrets or other confidential or proprietary
information of BI Austria that are unrelated to its obligations under this Agreement or are
unrelated to DRUG PRODUCT. BI Austria shall discuss with InterMune any comments provided by
InterMune on the Proposed Response; provided that InterMune shall have the final decision with
respect to those portions of the final written response or explanation to be provided to the HEALTH
AUTHORITIES that relate to DRUG PRODUCT manufactured hereunder. After the filing of a response with
the appropriate HEALTH AUTHORITIES, BI Austria will notify InterMune of any further contacts with
the HEALTH AUTHORITIES relating to BI Austria’s manufacture of DRUG PRODUCT hereunder.

     5.6.4 BI Austria shall promptly correct, and shall ensure that BI Pharma shall promptly
correct, any facility-related violations or deficiencies promptly at its own expense.
Process-related violations or deficiencies that are solely DRUG SUBSTANCE or DRUG PRODUCT-specific
shall be corrected promptly by BI Austria or BI Pharma, respectively, at InterMune’s cost.

5.7 Audits by InterMune

     5.7.1 InterMune shall have the right to inspect and audit both of BI Austria’s and BI Pharma’s
manufacturing facilities and records for regulatory compliance. These audits shall occur once per
calendar year upon reasonable notice, and more frequently for good and reasonable cause. BI Austria
shall respond in writing to InterMune regarding any items of non-compliance with cGMP identified by
InterMune during such audits, whether with respect to the BI Austria or the BI Pharma facility,
within [***] business days of InterMune’s notice thereof, and without delay remedy any such agreed
upon items of non-compliance with cGMP.

     5.7.2 If BI Austria can not remedy such non-compliance, whether with respect to the BI Austria or
the BI Pharma facility, within [***] business days of notice thereof BI Austria’s response shall
include a written plan and timetable including reasonable timelines. Considering the fact that BI
Austria is dependent on certain third parties to supply services to it, BI Austria shall use best
efforts to assign such timelines to these third parties accordingly in order to meet all timelines
for such remedy. Such plan and timetable shall be subject to

 

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22.

 

InterMune’s approval, which shall not unreasonably be withheld. In the event that BI Austria does
not respond with a plan and timetable as described above within such [***] day period, or InterMune
does not approve such proposed plan and timetable for good reason, the issue shall be forwarded to
the STEERING COMMITTEE for resolution. In the event InterMune approves such plan and timetable, but
BI Austria fails to remedy such non-compliance in accordance with such plan and timetable, then
InterMune shall [***]

5.8 Manufacturing Facilities

     BI Austria represents and warrants that it and BI Pharma 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.

5.9 Compliance with Law

     5.9.1 BI Austria shall comply, and shall ensure that its subcontractor BI Pharma shall comply
with, all local applicable rules, laws and regulations (including without limitation cGMP) in
performing its obligations under this Agreement. InterMune shall comply with all applicable rules,
laws and regulations in performing its obligations under this Agreement.

     5.9.2 All costs in connection with maintaining BI Austria’s and BI Pharma’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 Austria. BI Austria shall obtain and maintain, and
shall ensure that BI Pharma obtains and maintains, all permits and licenses necessary to its
performance under this Agreement at their own expense. All costs resulting out of the SERVICES
carried out at BI Austria or BI Pharma, respectively, related to compliance with regulatory
requirements that were not in effect as of the Effective Date concerning equipment and systems
solely DRUG PRODUCT-related shall be at InterMune’s expense.

5.10 Environmental

     BI Austria shall, and shall ensure that BI Pharma shall, properly dispose of any and all
hazardous waste materials involved with the manufacture of DRUG SUBSTANCE and DRUG 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 Austria’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 the SERVICES, OTHER SERVICES
and the manufacturing and supply of DRUG SUBSTANCE and DRUG

 

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23.

 

PRODUCT shall be overseen by the PROJECT TEAM, which shall be responsible for deciding operational
and scientific issues arising out of the SERVICES, the OTHER SERVICES or the manufacturing and
supply of DRUG SUBSTANCE and DRUG PRODUCT and unanimously agreeing in good faith with respect to
the monitoring of the SERVICES, the OTHER SERVICES and the manufacturing and supply of DRUG
SUBSTANCE and DRUG PRODUCT.

     6.1.2 The PROJECT TEAM shall consist of a team consisting of equal numbers of people, if
feasible, each appointed by InterMune and BI Austria 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
InterMune decreased, without the Parties’ prior written agreement. InterMune’s and BI Austria’s
respective members of the PROJECT TEAM as of the Effective Date are listed in Exhibit 6.

     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, provided that the PROJECT TEAM shall meet
at least once a year in a face-to-face meeting at a mutually agreed location.

     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 one (1)
copy of the minutes duly executed by the Parties’ PROJECT MANAGER.

     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.

     6.1.6 The Parties’ respective members of the PROJECT TEAM shall cooperate with one another in
good faith to ensure the timely reporting of any issues arising under this Agreement that may come
to a Party’s attention and to agree on a path forward to resolve such issues as promptly as
possible. Furthermore, the Parties’ respective members of the PROJECT TEAM shall use their best
efforts to provide to one another documents as far in advance as possible so the members will have
a reasonably sufficient time period to adequately review such documents without danger of causing
any delay in the activities set forth in this Agreement. This Section 6.1.6 is not intended to and
shall not effect any specific timelines for the performance of obligations set forth elsewhere in
this Agreement.

24.

 

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 InterMune and by BI Austria 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 the SERVICES or OTHER SERVICES 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 InterMune decreased, without the
Parties’ prior written agreement. The members of the STEERING COMMITTEE are listed in Exhibit 11.

     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 agree on an action
plan 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 InterMune and the
Chief Executive Officer/Managing Director of BI Austria 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 except as may be expressly
provided for in 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 INTERMUNE’S TECHNOLOGY shall remain with InterMune and shall not vest in BI
Austria.

7.2 The ownership of BI AUSTRIA’S TECHNOLOGY shall remain with BI Austria and shall not vest in
InterMune.

7.3 BI Austria shall retain ownership of BI AUSTRIA’S IMPROVEMENTS. BI Austria hereby grants to
InterMune an irrevocable, non-terminable, non-exclusive, perpetual, sublicenseable, royalty-free
license under BI AUSTRIA’S IMPROVEMENTS to develop, use, make, have made, import, offer for sale
and sell LICENSED PRODUCTS as defined in the SIDE LETTER AGREEMENT in the TERRITORY, whereby
InterMune shall assume the costs to be

 

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25.

 

paid by BI Austria for awards to inventors of BI AUSTRIA’S IMPROVEMENTS, as such awards are set
forth in written agreements between BI Austria and such inventor or in an applicable industry labor
contract.

7.4 [Intentionally omitted.]

7.5 InterMune hereby grants to BI Austria (with the right to sublicense solely to BI Pharma) a
non-exclusive, nontransferable license to use INTERMUNE’S TECHNOLOGY and AMGEN TECHNOLOGY solely
for the purpose of (a) performing the SERVICES and (b) manufacturing and supplying the DRUG
SUBSTANCE and DRUG PRODUCT for InterMune, as provided in this Agreement. The license granted under
this Section shall automatically terminate upon the expiration or termination of this Agreement.

7.6 The Parties agree that the terms of the SIDE LETTER AGREEMENT are hereby incorporated by
reference in this Agreement and that this Agreement shall constitute the “Manufacturing Sublicense”
as defined in the SIDE LETTER AGREEMENT for purposes thereof. Notwithstanding anything to the
contrary contained herein, in the event of any conflicts between the terms set forth in this
Agreement and those set forth in the SIDE LETTER AGREEMENT, the SIDE LETTER AGREEMENT will govern
to the extent of those conflicts.

8. Complaints; Adverse Events; Recalls 

8.1 InterMune shall inform BI Austria of any complaints, adverse reaction reports, safety issues or
toxicity issues relating to any DRUG PRODUCT of which it becomes aware, regardless of the origin of
such information, within the time frame required by cGMP but in no event later than two (2) days
from the initial complaint or report.

     8.1.1 InterMune 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
DRUG PRODUCT with the intention of complying with cGMP.

     8.1.2 If any such event occurs, BI Austria shall retain any unused supplies of such DRUG
PRODUCT and its associated components, and all associated batch and other production records in
such manner as InterMune may reasonably direct, and at InterMune’s expense, except to the extent
such event is caused by BI Austria’s wrongful act or omission. BI Austria agrees to respond to
InterMune in respect to such complaint investigations involving BI Austria’s manufacturing of a
DRUG PRODUCT, SERVICES or OTHER SERVICES rendered hereunder as soon as reasonably possible but in
any case within [***] days from receipt by BI Austria of the report of such complaint and sample
(if available), or in the case of a serious adverse event, within [***] from receipt of the report
of such complaint and sample (if available). InterMune 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 DRUG PRODUCT.

26.

 

8.2 If either Party becomes aware at any time of any defect or the possibility of any defect
associated with any DRUG PRODUCT manufactured by BI Austria hereunder, such Party will notify the
other Party immediately and confirm the notification as soon as possible in writing.

8.3 InterMune shall notify BI Austria promptly if any DRUG PRODUCT manufactured by BI Austria
hereunder is the subject of a recall and InterMune and/or its designee shall have the sole
responsibility for the handling and disposition of such recall. In the event that a recall is
reasonably deemed by InterMune as required in connection with BI Austria’s breach of any of its
warranties set forth in Section 9.2 hereof, which reasonableness shall be measured against whether
a reasonable third party in the position of InterMune would conduct a recall if it was faced with
the same facts and circumstances, BI Austria shall (i) either, at InterMune’s option, [***]
InterMune for [***] of such DRUG PRODUCT or [***] the non-conforming DRUG PRODUCT with conforming
DRUG PRODUCT [***] (ii) [***] InterMune for [***] and [***] (including, without limitation, the
[***] [***] and for [***] conforming DRUG PRODUCT, (iii) [***] InterMune the [***] for [***] and
(iv) [***] InterMune for [***] with the actual conduct of such DRUG PRODUCT recall, but only to the
extent that the [***] and provided, however, that [***] shall not exceed an amount that equals
[***] In all other events of a recall, all [***] by InterMune. InterMune 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 field correction with respect to the DRUG PRODUCT. Nothing set forth
in this Section 8.3 shall limit BI Austria’s indemnification obligations set forth in Section 10.

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 liability of [***] 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 [***] combined
single limit for bodily injury and broad form property damage.

 

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27.

 

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 Austria represents and warrants that:

     9.2.1 All DRUG SUBSTANCE manufactured hereunder shall — at the date of shipment to InterMune
(if applicable) — conform to DRUG SUBSTANCE SPECIFICATIONS;

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

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

     9.2.4 All DRUG SUBSTANCE and DRUG PRODUCT manufactured hereunder shall be manufactured,
handled, stored and transported (from BI Austria to BI Pharma) in accordance with the cGMP
requirements and all applicable laws, regulations and ordinances of the jurisdiction in which such
manufacture occurs.

     9.2.5 No DRUG PRODUCT manufactured and supplied to InterMune hereunder shall be (i)
adulterated or misbranded by BI Austria 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 Austria shall not use and shall secure that BI Pharma 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 DRUG PRODUCT under this Agreement.

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

10. Indemnification

10.1 Subject to Section 10.3., BI Austria shall indemnify, defend and hold harmless InterMune and
its officers, directors, employees and agents from and against [***] (collectively, “LIABILITIES”)
arising out of or resulting from [***] by BI Austria or BI Pharma relating to the subject matter of
this Agreement, or [***] in

 

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28.

 

[***] (except to the extent such LIABILITIES arose or resulted from any willful or negligent act or
omission by InterMune).

10.2 Subject to Section 10.3, InterMune shall indemnify, defend and hold harmless BI Austria and
its officers, directors, employees and agents from and against all LIABILITIES arising out of or
resulting from [***] matter of this Agreement, or the [***] that arises out of this Agreement
(except to the extent such LIABILITIES arose or resulted from any willful or negligent act or
omission by BI Austria or BI Pharma or [***] or [***]

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 or claim by a third party against the INDEMNITEE or of
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 the INDEMNITOR’s
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. In any action, claim or other matter where the INDEMNITOR
does not assume control of the proceeding, such action, claim or proceeding shall not be settled
without the prior written consent of the INDEMNITOR, which shall 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 BI Austria’s liability under this Agreement shall [***] [***] [***] [***] under this Agreement
except such limitation on liability shall not apply for [***] by BI Austria.

 

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29.

 

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 (and in the case of BI
Austria as the disclosing party, to BI Austria’s AFFILIATE BI Pharma) who are bound by written
obligations of confidentiality and non-use consistent with those set forth in this Agreement. The
Party disclosing the other Party’s CONFIDENTIAL INFORMATION to its employees, contractors and
agents (and in the case of BI Austria as the disclsing party, to its AFFILIATE BI Pharma) shall be
responsible for any breach of the confidentiality obligations by such parties.

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 DRUG 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, 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 by the US
Securities and Exchange Commission, and except as may be authorized 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. The Parties shall agree in advance on a period of time for review of
such draft press release, which period of time shall not exceed ten (10) calendar days from the
date of receipt by the other Party of the draft press release. In the event of 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 such ten (10) calendar days of such Party’s receipt of such
press release, the other Party shall be free to proceed with the press release without giving the
Party any further opportunity for providing input. 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. In the event a Party is
required to file a copy of this Agreement pursuant to the rules and regulations promulgated by the
US Securities and Exchange Commission, such Party shall seek appropriate confidential treatment of
CONFIDENTIAL INFORMATION of the other Party

30.

 

(e.g., financial terms, trade secrets, or other confidential commercial information). Prior to the
submission of a copy of this Agreement for filing, the Party required to make such submission shall
provide written notice to the other Party about the submission and to the extent confidential
treatment is sought, shall give the other Party a reasonable amount of time to comment on such
submission (not to exceed twenty-one (21) calendar days) from the date of the notice and shall use
its reasonable efforts to incorporate the other Party’s comments, if any for confidential
treatment.

12.5 This confidentiality obligations of this Article 12 shall survive the termination or
expiration of this Agreement for a period of five (10) years. Notwithstanding the foregoing, with
respect to any Amgen INFORMATION and Amgen MATERIALS (as such terms are defined in the Confidential
Disclosure Agreement dated February 17, 2005 among InterMune, BI Austria and Amgen), such Amgen
INFORMATION and Amgen MATERIALS shall be governed and protected under the terms of such
Confidential Disclosure Agreement.

13. Duration and Termination

13.1 Duration

     This Agreement shall be effective as of the Effective Date and shall continue in force until
December 31, 2015. This Agreement shall automatically renew for successive five (5) year periods,
provided, however, that either Party may elect not to renew this Agreement by providing the other
Party written notice of such election at least thirty-six (36) months prior to the date of
expiration of the then-current term. In the event that BI Austria decides not to renew such
Agreement, upon InterMune’s request, BI Austria shall provide reasonable assistance to InterMune in
transferring the MANUFACTURING PROCESS to another supplier designated by InterMune by providing
reasonable technical assistance and documentation relating to the manufacture, testing and supply
of DRUG SUBSTANCE and the DRUG PRODUCT as necessary. Such reasonable assistance shall encompass
provision of documentation in the most current version which is not yet in possession of Intermune
at the time, and technical assistance by BI Austria to an extent to be agreed upon by the Parties
in good faith. Technical assistance shall be provided [***]. In the event that the transfer of the
MANUFACTURING PROCESS is not yet completed and InterMune has not yet received the necessary
regulatory approvals from the appropriate HEALTH AUTHORITIES to market INTERFERON ALFACON-1
manufactured by a third party manufacturer (despite InterMune’s use of diligent efforts) upon the
expiration of the aforementioned thirty-six (36) month notice period, BI Austria shall continue to
supply to InterMune and InterMune shall continue to purchase from BI Austria DRUG PRODUCT for a
maximum period of [***] following the thirty-six (36) month notice period.

13.2 Early Termination

     13.2.1 In the event that a Party materially breaches its obligations under this Agreement (with the
exception of a MATERIAL SUPPLY BREACH which shall be subject to Section 3.8.1), the non-breaching
Party may terminate this Agreement upon [***] 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. In the event the identified breach is

 

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31.

 

of such a nature so that it is incapable of cure within [***], then the Parties will work together
in good faith to agree on an action plan to cure such breach; provided, however, that if the
Parties are unable to agree on such an action plan after good faith efforts by each Party within
[***], then the non-breaching Party will have the right to terminate this Agreement upon notice to
the breaching Party. Notwithstanding the preceding sentence, in the event that a Party materially
breaches its obligations under this Agreement more than [***] times in any consecutive [***]
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.

     13.2.3 InterMune may immediately terminate this Agreement by notice in writing if InterMune
should be prevented by the HEALTH AUTHORITIES from using DRUG PRODUCT in clinical trials for all
indications or from distributing DRUG PRODUCT on the market for all indications. In such event,
InterMune shall be responsible to BI Austria for the following: (A) InterMune shall either (at
InterMune’s discretion) (i) purchase the DRUG PRODUCTS in accordance with the then existing firm
forecast (i.e., the red zone) (in which case BI Austria agrees to sell such DRUG PRODUCTS to
InterMune) or (ii) pay BI Austria an amount equal to [***] percent of the unit price of the DRUG
PRODUCT then in effect for the DRUG PRODUCT forecasted in the then existing firm forecast [***] and
(B) InterMune shall [***] BI Austria for [***]; provided that InterMune shall have no liability to
BI Austria under this Section 13.2.3 in the event that such HEALTH AUTHORITY action is solely due
to any breach of BI Austria’s warranties under this Agreement or any negligence or willful
misconduct by BI Austria or BI Pharma.

     13.2.4 In the event of an assignment of this Agreement by a Party hereunder, termination
rights of the other Party are addressed in Section 14.3.

     13.2.5 This Agreement shall be terminated in the event of early termination of the License and
Commercialization Agreement dated June 15, 2001, as amended, between Amgen and InterMune.

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

13.3 Effect of Termination

     13.3.1 In the event of any termination of this Agreement (other than for BI Austria’s material
breach or negligence or willful misconduct by BI Austria or BI Pharma), InterMune shall also do one
of the following (at InterMune’s option): (i) InterMune shall purchase (in which case BI Austria
shall sell) DRUG PRODUCT forecasted for [***] and for [***] of the then existing

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

32.

 

forecast or (ii) InterMune shall pay to BI Austria an amount equal to [***] percent of the unit
price of the DRUG PRODUCT then in effect for the DRUG PRODUCT forecasted for [***]; provided,
however, that with regard to any DRUG PRODUCT already produced by BI Austria (or BI Pharma, as the
case may be) at the time of termination, InterMune shall [***] Notwithstanding the foregoing, in
the event of termination by InterMune under Section 13.2.3, Section 13.2.3 shall govern rather than
this Section 13.3.1.

     13.3.2 In the case of any termination, except for termination resulting from BI Austria’s
breach or negligence or willful misconduct by BI Austria or BI Pharma, BI Austria shall receive
[***], to the extent BI Austria has not yet received all such payments at the time of termination.

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

     13.3.4 In the event of any termination or expiration of this Agreement, BI Austria shall
promptly return all of InterMune’s CONFIDENTIAL INFORMATION to InterMune, except for a single copy
and/or sample of each item for documentation purposes only. BI Austria’s responsibility to keep and
store all other materials provided by InterMune in the course of this Agreement shall terminate six
(6) months after expiration or termination of this Agreement (except as otherwise provided in
Section 5.2).

     13.3.5 In the event of any termination or expiration of this Agreement, InterMune shall
promptly return all of BI Austria’s CONFIDENTIAL INFORMATION to BI Austria, except for a single
copy and/or sample for documentation purposes only.

     13.3.6 Except as set forth in Section 3.8.1(iii), Section 13.1 and Section 14.3, BI Austria
shall not be obligated to provide to InterMune any assistance in transferring the MANUFACTURING
PROCESS to a third party other than providing documentation (e.g., batch records and
specifications) in the most current version which is not yet in possession of Intermune at the
time.

     13.3.7 The following provisions shall survive termination or expiration of this Agreement:
Sections 3.8.1, 5.2.3, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 8, 10, 11, 12, 13.2.3, 13.2.6, 13.3 and 14 and
any other Section which by its nature should survive. Termination or expiration 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.

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

33.

 

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 exhaust any right, power or remedy, or proceed 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 Austria’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 [***] 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 except to an AFFILIATE of either one of the
Parties without the prior written consent of the other Party which shall not be unreasonably
withheld or delayed. 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. In the case of assignment to an AFFILIATE as permitted under
this Section 14.3.1, the assigning Party shall promptly notify the other Party in writing.

     14.3.2 Notwithstanding the foregoing, InterMune shall have the right to assign this Agreement
in case of a merger, acquisition or sale of substantially all of its assets that relate to this
Agreement after due written notification of BI Austria.

     14.3.3 In the event that either Party assigns this Agreement as permitted under this Section 14.3,
the other Party shall have the right to terminate this Agreement upon [***] written notice;
provided, however, that (i) a Party shall not have the right to terminate in the event of
assignment of the Agreement by the other Party to an AFFILIATE existing on the Effective Date in
accordance with Section 14.3.1, (ii) in the event BI Austria assigns the Agreement to an AFFILIATE
not in existence on the Effective Date and such assignment would

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

34.

 

have no impact on the day-to-day operations of BI Austria such that the same facility in Vienna
would continue to perform its manufacturing obligations under this Agreement, then InterMune shall
not have the right to terminate such Agreement under this Section 14.3.3; (iii) in the event
InterMune assigns this Agreement under Section 14.3.2, BI Austria shall have the right to terminate
only if the assignee is a competing contract manufacturing organization which manufactures
biopharmaceuticals. In the event InterMune assigns this Agreement under Section 14.3.2 before the
completion of the SERVICES and such assignee is a competing contract manufacturing organization
which manufactures biopharmaceuticals and BI Austria desires to terminate this Agreement under this
Section 14.3.3, BI Austria shall provide written notice of termination to InterMune and its
assignee no later than [***] as of BI Austria’s receipt of written notice of assignment from
InterMune and such termination shall be effective [***] after InterMune’s receipt of such notice of
termination rather than the aforementioned [***] notice period. In the event InterMune assigns
this Agreement under Section 14.3.2 after the completion of the SERVICES and such assignee is a
competing contract manufacturing organization which manufactures biopharmaceuticals and BI Austria
desires to terminate this Agreement under this Section 14.3.3, termination by BI Austria shall not
take effect until the manufacturing of INTERFERON ALFACON-1 is transferred from BI Austria to a
third party manufacturer and InterMune (or its assignee, as applicable) receives the necessary
regulatory approvals from the appropriate HEALTH AUTHORITIES to market INTERFERON ALFACON-1
manufactured by such third party manufacturer but no later than [***] after notice of termination
by BI Austria to InterMune. With respect to the preceding sentence, upon InterMune’s (or its
assignee’s) request, BI Austria shall provide [***] InterMune in [***] by [***] relating to the
manufacture, testing and supply of DRUG SUBSTANCE and the DRUG PRODUCT as necessary. Such [***]
shall [***] which is not yet in possession of Intermune at the time, and technical assistance by BI
Austria to an extent to be agreed upon by the Parties in good faith. Technical assistance shall be
provided at BI Austria’s [***] rate. BI Austria may at its discretion require InterMune (or its
assignee, as applicable), to engage, at InterMune’s (or its assignee’s) cost, an independent third
party to perform on InterMune’s (or its assignee’s) behalf any on-site reviews, audits, document
reviews or any other tasks necessary in order to transfer the manufacturing to a third party
manufacturer such that the assignee will not have direct access to BI Austria’s CONFIDENTIAL
INFORMATION and such independent third party’s disclosure of BI Austria’s CONFIDENTIAL INFORMATION
to such assignee will be limited to the full extent possible in order to protect BI Austria’s
CONFIDENTIAL INFORMATION.

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

 

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35.

 

prepaid or (iii) delivered by facsimile and confirmed by certified or registered mail to the
addresses or facsimile numbers set forth below:

	 	 	 
	If to InterMune:

	 	InterMune Pharmaceuticals, Inc.
	 

	 	3280 Bayshore Boulevard
	 

	 	Brisbane, California 94005 USA
	 

	 	Facsimile: 415-466-2300
	 

	 	Attention: General Counsel
	 
	 	 
	If to BI Austria:

	 	Boehringer Ingelheim Austria GmbH
	 

	 	Dr. Boehringer-Gasse 5 – 11
	 

	 	A-1121 Vienna, Republic of Austria
	 

	 	Facsimile: +43 – 1 – 801 05 — 2440
	 

	 	Attention: Monika Henninger
	 

	 	Customer Relations and Projects
	 
	 	 
	with a copy to:

	 	Boehringer Ingelheim GmbH
	 

	 	Binger Strasse 173
	 

	 	D-55 216 Ingelheim am Rhein
	 

	 	Facsimile: +49 – 61 32 77 – 98 287
	 

	 	Attention: Rolf G. Werner
	 

	 	Corporate Division 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 InterMune and the Chief Executive Officer of BI
Austria 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 the Chief Executive Officer of InterMune and the Chief Executive Officer of BI Austria 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 demand for arbitration may
be filed by either Party within a reasonable time after the executive mediation in accordance with
Section 14.5.1 has concluded, but no later than after the date upon which institution of legal
proceedings shall be barred by the applicable statute of limitations. There shall be three (3)
arbitrators. Each Party shall designate one arbitrator and the two party-
designated arbitrators shall select the third. In the event of the any one or more of the
three (3)

36.

 

arbitrators has not been selected by the thirtieth (30th) day following the date of the
demand for arbitration, then such arbitrator shall be selected in accordance with the aforesaid
Rules. The language to be used in the arbitral proceedings shall be English. The place of
arbitration shall be San Francisco, California, USA in the event InterMune is the defendant and
Vienna, Austria in the event BI Austria is the defendant. 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. In the event of arbitration, the costs of the arbitration shall
be fixed in accordance with Article 31 of the Rules of Arbitration of the International Chamber of
Commerce and the final award will have the Parties bearing the costs of arbitration in proportion
to the outcome of the arbitration. If applicable under the applicable law, the Parties will submit
a proposed discovery schedule to the arbitrator(s) at the pre-hearing conference. The scope and
duration of discovery shall be reasonably determined by the arbitrators.

     14.5.3 This Agreement shall be governed by and construed in accordance with the laws of the
place of domicile of the defendant Party.

     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

     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 and the Exhibits set forth the entire agreement between the Parties, and
supersede all previous agreements, 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.

14.10 Headings

37.

 

     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.

38.

 

     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	 	 	Brisbane, California	 
	 	 
	 	 	 	 	 	 	 	 
	 	BOEHRINGER INGELHEIM

AUSTRIA GmbH	 	 	INTERMUNE, INC.	 
	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 
	 	By:

	 	/s/ Dr. Kurt Konopitzky
	 	 	By:
	 	/s/ Roger Hawley	 
	 	 

	 	 
	 	 	 	 	 	 
	 
	 	Name: Dr. Kurt Konopitzky	 	 	Name: Roger Hawley	 
	 
	 	Title: Head, Biopharmaceuticals Operations	 	 	Title: Executive
Vice President, 
          Commercial and Technical Operations	 
	 
	 	Date: November 2, 2005	 	 	Date: November 3, 2005	 
	 	 
	 	 	 	 	 	 	 	 
	 	By:

	 	/s/ Dr. Joseph Legerer
	 	 	By:
	 	/s/ Robin Steele	 
	 	 

	 	 
	 	 	 	 	 	 
	 
	 	Name: Dr. Joseph Legerer	 	 	Name: Robin Steele	 
	 
	 	Title: Head, Legal Department	 	 	Title: Senior Vice
President, General Counsel and Corporate

           Secretary	 
	 
	 	Date: November 2, 2005	 	 	Date: November 3, 2005	 
	 	 
	 	 	 	 	 	 	 	 
	 	By:

	 	/s/ Prof. Dr. Rolf G. Werner	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 
	 
	 	Name: Prof. Dr. Rolf G. Werner	 	 	 	 	 	 
	 
	 	Title: Head, Corporate Division

           Biopharmaceuticals	 	 	 	 	 	 
	 
	 	Date: November 3, 2005	 	 	 	 	 	 
	 	 	 	 	 	 

39.

 

Exhibit 1

[***]

 

***
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 2

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 3

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 4

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 5

[***]

 

***
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 6

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 7

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 8

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 9

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 10

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 11

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 12

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 13

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Exhibit 14

[***]

 

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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