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EXHIBIT 10.50  

[*]=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. 

 
 

AMENDMENT NUMBER 1    
  

        To the Development and Supply Agreement dated December 28, 2001 (the Agreement) between Abbott Laboratories ("Abbott") and InterMune, Inc.
("InterMune"). 

        Abbott
and InterMune agree to amend the Agreement as follows: 

        1.    The
parties agree to amend the scope of the project as set forth in Exhibit C of the Agreement. Exhibit C of the Agreement shall be amended to include the
work set forth on Attachment A hereto. 

        2.    Section 5.1(b)
is deleted in its entirety and replaced with the following: 

        The
remainder of the Fee will be invoiced and paid according to the annual payment schedule in Exhibit C.  [*] installments of the Research and Development
Fee shall be paid within  [*] of the receipt of each [*] Abbott invoice for the
amount due. Invoices shall precede, [*] from the previous  [*]

        3.    Section 8.3(b)
is deleted in its entirety and replaced with the following: 

        Quality Assurance.    Within [*]
after the date of the signing of this Agreement, representatives of the parties' Quality Assurance departments shall meet to develop and approve a quality agreement ("Quality Agreement") outlining the
responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Agreement include, but are not limited to recalls,
annual product reviews, returned goods, regulatory audits, compliance with cGMP, compliance with such other quality related concerns deemed appropriate. 

        Capitalized
terms used herein and not otherwise defined shall have the same meaning as under the Agreement. 

        Except
as specifically set forth above, all other terms and conditions of the Agreement shall remain in full force and effect. 

	INTERMUNE, INC.	 	ABBOTT LABORATORIES
	

By:	

/s/  PETER VAN VLASSELAER      
 Peter Van Vlasselaer	
 	

By:	

/s/  CHARLES T. MITCHELL      
 Charles T. Mitchell
	

Title:	

Sr. VP. Tech Ops
	
 	

Title:	

GM, Pharma

	

Date:	

4/26/02
	
 	

Date:	

April 25, 2002

 
 

Attachment A    
  

 
  ADDITIONAL ACTIVITIES AND FEES    
  

Scope Change 2A:

Characterization of Lilly Strain A82846-UV37-B  

        [*]

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AMENDMENT NUMBER 1

Attachment A

ADDITIONAL ACTIVITIES AND FEESEXHIBIT 10.51  

[*]=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. 

April 25,
2002 

Mr. Brad
Crawford

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799 

	Re:
	Amendment No. 1 to Amgen/InterMune License and Commercialization

Agreement for Infergen

Dear
Mr. Crawford: 

Our
signatures below approve this document as Amendment No. 1 ("Amendment") to that certain License and Commercialization Agreement, dated as of June 15, 2001, between Amgen Inc.
("Amgen") and InterMune, Inc. ("InterMune") (the "Agreement"). Amgen and InterMune shall be collectively referenced herein as the "Parties." 

For
good and valuable consideration, the receipt of which is hereby acknowledged, the Parties hereby agree as follows: 

	1.
	The second sentence of Section 1.27 of the Agreement (definition of Licensed Product) is hereby deleted in its entirety and
amended and superseded as follows: 

"Licensed
Products include but are not limited to Infergen and PEG-Infergen Products." 

	2.
	The following shall be added to the last sentence of Section 3.3 of the Agreement: 

",
and such PEG-Infergen Product shall be [*]" 

	3.
	The following shall be added to the last sentence of Section 5.2(b) of the Agreement: 

",
and such PEG-Infergen Product shall be [*]" 

	4.
	The first sentence of Section 6.3(a) of the Agreement is hereby terminated in its entirety and amended and superseded as follows: 

        "InterMune
shall pay to Amgen milestone payments as set forth in this Section 6.3(a) within [*] after the
first achievement of the corresponding milestone for a PEG-Infergen Product that (i) is pegylated [*] and/or
(ii) is pegylated [*] (in either case, an "Amgen PEG-Infergen Product") that is  [*] to be [*]

	5.
	The phrase [*] in Item 2 of the Milestone Events table in
Section 6.3 (b) of the Agreement shall be deleted and replaced with the phrase [*]

	6.
	In consideration for Amgen extending the know-how license granted to InterMune in Section 2.4 of the Agreement to
further allow InterMune to use Amgen Know-How for the sole purposes of [*] in the Territory and for its convenience,
InterMune proposed payment of [*]. Amgen accepted InterMune's proposal, and  [*]. Accordingly,Section 6.5 of the Agreement is hereby terminated in its
entirety and amended and superseded as follows: 

        "6.5 Term of Royalties.    Amgen's right to receive Royalties under Section 6.4 shall expire, on a Licensed
Product-by-Licensed Product basis, in each country of the Territory upon the [*]. Notwithstanding the
foregoing sentence, Amgen shall have the right to receive from InterMune, and 

1

 

InterMune shall be obligated to pay to Amgen, Royalties for any PEG-Infergen Product [*];  provided, however, that InterMune's obligation to pay Royalties
for any PEG-Infergen Product  [*] shall [*] if and  [*] as a [*] at  [*] that is a [*]
 

	7.
	This Amendment shall be deemed to amend terms of the Agreement pursuant to Section 15.1 thereof and the Agreement, as amended and
modified by this Amendment, shall remain in full force and effect and shall constitute the complete, final and exclusive understanding and agreement of the parties respecting the subject hereof and
thereof.

	8.
	Whenever possible, each provision of this Amendment shall be interpreted in such a manner as to be effective and valid under applicable
law, but should any provision of this Amendment be held to be prohibited or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity,
without invalidating the remainder of this Amendment.

	9.
	This Amendment shall be governed by and interpreted in accordance with the substantive laws of the State of California and the Parties
hereby submit to the jurisdiction of the California courts, both state and federal.

	10.
	No amendment, modification or supplement of any provision of this Amendment shall be valid or effective unless made in writing and
signed by a duly authorized officer of each Party.

	11.
	This Amendment may be signed in any number of counterparts, each of which shall be an original, with the same effect as though the
signatures hereto and thereto were on the same instrument.

	12.
	This Amendment No. 1 to the Agreement is made effective as of April 25, 2002. 

IN WITNESS THEREOF, the parties have executed this Amendment No. 1 to the Agreement as of the date(s) set forth below. 

	INTERMUNE, INC.	 	AMGEN INC.
	

By:	

/s/  STEPHEN N. ROSENFIELD      	
 	

By:	

/s/  SCOTT J. FORAKER      
	

Print Name:    Stephen N. Rosenfield	
 	

Print Name:    Scott J. Foraker
	

Title:	

Senior Vice President of Legal Affairs and General Counsel	
 	

Title:	

VP Licensing
	Date:	4/24/02	 	Date:	4/24/02

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EXHIBIT 10.52  

[*]=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. 

 
 

FIRST AMENDMENT TO THE
  
    DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT    
  

        THIS FIRST AMENDMENT to the Data Transfer, Clinical Trial and Market Supply Agreement (the "First Amendment"), is made effective as of the
19h day of June, 2002 (the "Amendment Date") by and between InterMune, Inc. ("InterMune"), a Delaware 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 and BI Austria are parties to the Data Transfer, Clinical Trial and Market Supply Agreement dated the
27th of January, 2000 (the "Agreement"); and 

        WHEREAS, relative to the Agreement as originally executed, InterMune and BI Austria have agreed to increased volume and capacity
commitments on the part of each Party, and modified pricing and other terms, all as further set forth herein, and wish to amend the Agreement to reflect such terms; 

        WHEREAS, InterMune and BI Austria have commenced some additional work and desire to contract for additional services not originally
contemplated by the Agreement. These additional services consist of certain process optimization and development work with the objective to establish a robust, high-yield, and large scale
process for production of Actimmune drug substance suitable to meet the increased market demand of product. 

        NOW, THEREFORE, the Parties hereto agree as follows: 

	1.
	The Austrian Shilling is defined in the Agreement as "ATS" in Section 1.3 of the Agreement. The Parties recognize that the
Austrian Shilling has been replaced by the Euro. Section 4.1 of the Agreement says that payments under the Agreement become due in an equivalent amount of Euros instead of Austrian Shillings
once the Euro replaces the Austrian Shilling. The Parties agree that this has happened, and that payments under the Agreement shall be in Euros from now on. The new pricing terms being added to the
Agreement by this First Amendment are stated in Euros. The Agreement is hereby amended to add as Section 1.18(b) the following definition: 

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

	2.
	The Agreement is hereby amended to insert as Section 1.38(b) of the Agreement, immediately following Section 1.38 of the
Agreement, the following definition: 

        [*]

	3.
	The Agreement is hereby amended to insert a new Section 2.1.7 after Section 2.1.6, as follows: 

"InterMune
grants BI Austria a right of first negotiation for the manufacture for clinical and commercial supply of any [*] as
follows: If InterMune pursues the development of any [*] then prior to  [*], InterMune shall notify BI Austria in writing. If BI Austria responds in writing
within  [*] after any such notice from InterMune that BI Austria wishes to negotiate with InterMune the terms upon which BI Austria
would be willing to manufacture and supply exclusively to InterMune, and InterMune would be willing to purchase from BI Austria, quantities of such product as clinical and commercial supply, then the
Parties shall negotiate in good faith such terms for a period of not less than [*] If the Parties do not reach agreement and
execute a written agreement setting 

1

 

forth such terms during such time period, then InterMune shall have no further obligation to BI Austria with respect to the manufacture and supply  [*]." 

	4.
	The Agreement is hereby amended to delete in its entirety the second (2nd) paragraph of Section 3.2.1 and replace
such paragraph with the following: 

"Following
BI Austria's and BI Pharma KG's FDA approval to manufacture PRODUCT for market supply, InterMune shall order the requested amounts of PRODUCT. In any case the  [*] 

	5.
	The Agreement is hereby amended to insert a new Section 3.2.6 after Section 3.2.5, as follows: 

"3.2.6    If
InterMune determines that [*] vials of PRODUCT per year exceeds InterMune's annual requirements for
PRODUCT, then InterMune may so notify BI Austria, stating the number of vials of PRODUCT that InterMune predicts it will actually require going forward from the date of InterMune's notice (the
"Revised Level"). If InterMune provides BI Austria with such a notice, then: 

        3.2.6.1    InterMune
shall purchase (in due course on the timeline otherwise provided for hereunder) the quantities for delivery in the  [*] quarters of the then-current forecast pursuant to Section 3.2.1 then in
effect. In such event, the  [*] quarters of such forecast shall also become binding so that all costs for PRODUCT ordered for delivery in the
[*] quarters fall due and have to be paid by InterMune; (for the avoidance of doubt, the amounts forecast for such  [*] shall [*]
 as the  [*] in accordance with Section 3.2.3); also for the avoidance of doubt, InterMune shall also purchase from BI Austria any
quantities of PRODUCT delivered in accordance with any purchase order hereunder in effect at the time of InterMune's notice. 

        3.2.6.2    And,
the Parties shall negotiate in good faith (a) any adjustments to the financial terms of this Agreement that may be required to reflect  [*] associated with [*] rather than on the scale of  [*] vials per year, and (b) a [*] on the part of
BI Austria pursuant to Section [*] Such [*] at the  [*] may include a [*]
to  [*] to manufacture PRODUCT at the scale of [*] vials per
year, which [*] cannot be [*] if not  [*] PRODUCT for InterMune at the Revised Level. Such [*]
shall be subject to audit by an independent accountant [*] to BI Austria concurrently with the negotiations." 

	6.
	The Agreement is hereby amended to delete Section 3.3.4 is in its entirety and replace it with the following: 

"InterMune
shall be obligated to buy and BI Austria shall be obligated to sell only the quantities of PRODUCT which are subject to a purchase order accepted by BI Austria;  provided that BI Austria shall accept
sufficient purchase orders from InterMune annually to meet its obligations pursuant to Section 3.6.2 and in
accordance with the rolling forecast model pursuant to Section 3.2.1. 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." 

	7.
	The Agreement is hereby amended to delete Section 3.6.2 in its entirety and replace it with the following: 

"BI
Austria guarantees to have reserved the capacity to manufacture, and to have manufactured at BI Pharma KG (i) a minimum of  [*] vials per year through calendar year [*]
;
(ii) a minimum of [*] vials per year [*]; and
(iii) a minimum of [*] vials in each calendar year thereafter during the term of this Agreement. Such vials may be
packaged and labeled for market supply, or unpackaged and/or unlabeled for clinical supply, as requested by InterMune in its purchase orders therefore. InterMune presumes that the amount of vials
requested per year might exceed such minimum number of vials in the years in which such minimums apply as set forth above. Should it become at any time apparent that InterMune requires a greater
quantity of PRODUCT than the minimum required of BI Austria as set forth above for any particular year, InterMune will notify BI Austria thereof. BI Austria shall inform as soon as reasonably possible
InterMune [*] vials for the 

2

 

applicable calendar year. The Parties acknowledge that a lead time of up to [*] years may be required  [*] to manufacture [*]
. Upon agreement on the costs and
lead time BI Austria shall reserve the capacity needed for the increased demand of PRODUCT. 

Should
it become at any time apparent that it would not be feasible for BI Austria to provide manufacturing capacity at BI Austria for  [*] (i) equivalent to [*] vials, during any
calendar year [*]; (ii) equivalent to [*] vials
per year, [*]; or (iii) equivalent to at least  [*] vials per year, during any calendar year after [*],
BI Austria will notify InterMune thereof." 

	8.
	The Agreement is hereby amended to insert a new Section 2.2.8. after Section 2.2.7, as follows: 

"Development
and Scale-up of the MANUFACTURING PROCESS. The Parties decided to conduct a development program to develop a robust, high-yield, and large scale process for
production of BBS (1.11) suitable to meet the increased market demand of PRODUCT. The Parties decided to conduct such a program as additional services under this Agreement, but the  [*] in this Agreement
as originally executed. As of the Amendment Date (as defined in the First Amendment to this Agreement),
the Parties have commenced and have plans to continue certain additional services, and have agreed upon the financial terms and work plans for such additional services. All such additional services
that have been agreed upon by the Parties as of the Amendment Date are listed in Appendix D to this First Amendment and shall be carried out by the Parties in accordance with the work plan
referenced in Exhibit D. All costs arising out of such additional services shall be paid in accordance with the respective payment schedule as also listed in Appendix D to this First
Amendment. If the Parties plan and agree upon new process development projects pursuant to this Agreement beyond that which is agreed upon on the Amendment Date, they will exchange written plans for
such work and the financial terms, if any, therefor, prior to commencing the work." 

	9.
	The Agreement is hereby amended to delete the number "2006" in Section 13.1 and replace it with the number  [*]
	10.
	The Agreement is hereby amended to delete in its entirety Section 14.4 and replace it with the following: 

"Notices

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

	

If to InterMune:	
 	

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, CA 94005 USA

Facsimile:    +1 - 415 - 466 - 2340

Attention:    Peter Van Vlasselaer
	

with a copy to:	
 	

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, CA 94005 USA

Facsimile:    +1 - 415 - 508 - 0006

Attention:    General Counsel
	
 	
 	

 

3

 

	

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

Corporate Division Biopharmaceuticals
	

with a copy to:	
 	

Business Support Biotech

Boehringer Ingelheim GmbH

Binger Strasse 173

D-55 216 Ingelheim am Rhein

Facsimile:    +49 - 61 32 77 - 98 287

Attention:    Rolf G. Werner

	11.
	The Agreement is hereby amended to delete in their entireties Exhibit 8, and replace it with the replacement exhibit appended
hereto as Appendix B to apply going forward from the Amendment Date. The Agreement is hereby amended to provide an Appendix C, to apply to pricing for PRODUCT delivered under the
Agreement on or after [*]. All references in the Agreement to Exhibit 17 shall be deemed to refer to Appendix C
whenever relating to PRODUCT delivered on or after [*]. The prices for PRODUCT delivered  [*] continue to be as set forth in Exhibit 17 to the
Agreement. The Agreement is hereby amended by a new
Appendix D, listing all additional services to be carried out by BI Austria and the corresponding payment schedule. 
	12.
	The Table of Contents attached to this First Amendment as
Appendix A is hereby appended to the Agreement. 
	13.
	The miscellaneous provisions included in the Agreement in Article 14 shall govern this First Amendment in the same way that
they
govern the Agreement. 
	14.
	This First Amendment amends the terms of the Agreement. Except as stated in this First Amendment, the Agreement remains in full force
and effect. 

In Witness Whereof, the Parties hereto have caused this First Amendment to be executed by their duly authorized representatives as of the Amendment
Date. 

	Vienna, Austria	 	Brisbane, California

	

BOEHRINGER INGELHEIM	
 	

INTERMUNE, Inc.
	

AUSTRIA GmbH	
 	

 	

 
	

By:	

/s/  KURT KONOPITZKY      
	
 	

By:	

/s/  W. SCOTT HARKONEN      

	

Name:	

Dr. Kurt Konopitzky	
 	

Name:	

Scott Harkonen, MD
	

Title:	

Head of Biopharmaceutical Operations	
 	

Title:	

Chief Executive Officer
	

Date:	

19 June 2002	
 	

Date:	

19 June 2002
	

By:	

/s/  PROF WERNER      
	
 	

By:	

/s/  PETER VAN VLASSELAER      

	

Name:	

Prof. Dr. Rolf G. Werner	
 	

Name:	

Peter Van Vlasselaer, Ph.D.
	

Title:	

Head of Corporate Division Biopharmaceuticals	
 	

Title:	

Sen. Vice President Techn. Operations
	

Date:	

19 June 2002	
 	

Date:	

19 June 2002

4

  

 
 

APPENDIX TO FIRST AMENDMENT continued
  dated 11 June, 2002    

	1.	 	DEFINITIONS	 	2
	 	 	1.1	 	AFFILIATE	 	2
	 	 	1.2	 	APPROVAL	 	2
	 	 	1.3	 	ATS	 	3
	 	 	1.4	 	BI AUSTRIA'S IMPROVEMENTS	 	3
	 	 	1.5	 	BI AUSTRIA'S TECHNOLOGY	 	3
	 	 	1.6	 	BI TERRITORY	 	3
	 	 	1.7	 	BII	 	3
	 	 	1.8	 	BI PHARMA KG	 	3
	 	 	1.9	 	BI PRODUCT	 	3
	 	 	1.10	 	BLA	 	3
	 	 	1.11	 	BULK BIOLOGICAL SUBSTANCE (BBS)	 	3
	 	 	1.12	 	BULK SPECIFICATIONS	 	4
	 	 	1.13	 	cGMP	 	4
	 	 	1.14	 	CMC	 	4
	 	 	1.15	 	COA	 	4
	 	 	1.16	 	COC	 	4
	 	 	1.17	 	CONFIDENTIAL INFORMATION	 	4
	 	 	1.18	 	CONTROLLED	 	4
	 	 	1.18(b)	 	EURO	 	See First Amendment
	 	 	1.19	 	FDA	 	4
	 	 	1.20	 	FD&C ACT	 	5
	 	 	1.21	 	FILLING SITE CHANGE	 	5
	 	 	1.22	 	FINAL RELEASE	 	5
	 	 	1.23	 	GENENTECH PRODUCT	 	5
	 	 	1.24	 	Genentech Technology	 	5
	 	 	1.25	 	HEALTH AUTHORITIES	 	5
	 	 	1.26	 	INFORMATION	 	5
	 	 	1.27	 	INTERFERON-GAMMA l b	 	5
	 	 	1.28	 	INTERMUNE'S Technology	 	6
	 	 	1.29	 	MCB	 	6
	 	 	1.30	 	MANUFACTURING PROCESS	 	6
	 	 	1.31	 	Material Supply Breach	 	6
	 	 	1.32	 	PRODUCT	 	6
	 	 	1.33	 	PROJECT MANAGER	 	6
	 	 	1.34	 	PRODUCT SPECIFICATIONS	 	6

i

 

	 	 	1.35	 	PROJECT TEAM	 	6
	 	 	1.36	 	QUALITY ASSURANCE REQUIREMENTS	 	7
	 	 	1.37	 	RELEASE	 	7
	 	 	1.38	 	SERVICES	 	7
	 	 	[*]	 	 	 	 	 	 
	 	 	1.39	 	STEERING COMMITTEE	 	7
	 	 	1.40	 	TERRITORY	 	7
	 	 	1.41	 	US	 	7
	2.	 	DATA TRANSFER AND PRODUCT COMPARISON	 	8
	 	 	2.1	 	InterMune's Tasks and Responsibilities	 	8
	 	 	 	 	2.1.1	 	Documentation	 	8
	 	 	 	 	2.1.2	 	Material	 	8
	 	 	 	 	2.1.3	 	Data	 	8
	 	 	 	 	2.1.4	 	Support	 	8
	 	 	 	 	2.1.5	 	Contact with HEALTH AUTHORITIES	 	9
	 	 	 	 	2.1.6	 	Shipment of Material by InterMune	 	9
	 	 	2.2	 	BI Austria's Tasks and Responsibilities	 	10
	 	 	 	 	2.2.1	 	Comparison of Documentation and Materials	 	10
	 	 	 	 	2.2.2	 	Production Runs	 	10
	 	 	 	 	2.2.3	 	Additional Runs	 	10
	 	 	 	 	2.2.4	 	Additional Documentation	 	10
	 	 	 	 	2.2.5	 	Regulatory Support	 	11
	 	 	 	 	2.2.6	 	Format and Content of Documents	 	11
	 	 	 	 	2.2.7	 	Standard of Performance	 	12
	3.	 	MANUFACTURE AND SUPPLY	 	12
	 	 	3.1	 	General	 	12
	 	 	3.2	 	Forecasts	 	13
	 	 	3.3	 	Purchase Orders	 	15
	 	 	3.4	 	Shipment of PRODUCT and Material by BI Austria	 	15
	 	 	3.5	 	Testing and Rejection	 	16
	 	 	3.6	 	Increase of Manufacturing Capacity	 	17
	 	 	3.7	 	Second Source Manufacturer	 	18
	 	 	3.8	 	Material SUPPLY BREACH	 	19
	4.	 	PRICES AND PAYMENT	 	20
	5.	 	QUALITY ASSURANCE AND COMPLIANCE WITH LAW	 	21
	 	 	5.1	 	Release of Product	 	21
	 	 	5.2	 	Storage of Records and Batch Samples	 	22
	 	 	5.3	 	Final Release	 	23

ii

 

	 	 	5.4	 	Third Party Services	 	23
	 	 	5.5	 	Consent to Changes	 	23
	 	 	5.6	 	Inspections by HEALTH AUTHORITIES	 	23
	 	 	5.7	 	Audits by InterMune	 	25
	 	 	5.8	 	Manufacturing Facilities	 	26
	 	 	5.9	 	Compliance with Law	 	26
	 	 	5.10	 	Environmental	 	26
	6.	 	CO-OPERATION AND CO-ORDINATION BETWEEN THE PARTIES	 	27
	 	 	6.1	 	PROJECT TEAM	 	27
	 	 	6.2	 	Steering Committee	 	28
	 	 	6.3	 	Limitation of Powers	 	29
	7.	 	INTELLECTUAL PROPERTY AND LICENSES	 	29
	 	 	7.6	 	New Indications	 	30
	8.	 	COMPLAINTS; ADVERSE EVENTS; RECALLS	 	31
	 	 	8.4	 	Insurance	 	31
	9.	 	REPRESENTATIONS AND WARRANTIES	 	32
	10.	 	INDEMNIFICATION	 	34
	11.	 	LIMITATIONS ON LIABILITY	 	35
	12.	 	CONFIDENTIALITY	 	36
	13.	 	DURATION AND TERMINATION	 	37
	 	 	13.1	 	Duration	 	37
	 	 	13.2	 	Early Termination	 	37
	 	 	13.3	 	Effect of Termination	 	38
	14.	 	MISCELLANEOUS	 	39
	 	 	14.1	 	Performance by Affiliates	 	39
	 	 	14.2	 	Force Majeure	 	40
	 	 	14.3	 	Assignment	 	40
	 	 	14.4	 	Notices	 	41
	 	 	14.5	 	Dispute Resolution; Governing Law	 	42
	 	 	14.6	 	Independent Contractor	 	42
	 	 	14.7	 	Waiver	 	42
	 	 	14.8	 	Severability	 	43
	 	 	14.9	 	Entire Agreement	 	43
	 	 	14.10	 	Headings	 	43
	 	 	14.11	 	Ambiguities	 	43
	 	 	14.12	 	Counterparts	 	43
	 	 	14.13	 	English Language	 	43

iii

  

 
 

APPENDIX B TO FIRST AMENDMENT continued
  dated 11 June, 2002    

Appendix B replaces EXHIBIT 8 to the Agreement  

 Project Manager and Project Team:  

 BI Austria and BI Pharma KG  

	

Project Manager:	
 	

Dr. Monika Henninger, Business Support Biotech
	

Project Team:	
 	
[*]
	

 	
 	
[*]
	

 	
 	
[*]
	

 	
 	
[*]
	

 	
 	
[*]
	

 	
 	
[*]
	
InterMune	
 	

 
	

Project Manager:	
 	

Peter Van Vlasselaer, Ph.D., Senior VP Technical Operations
	

Project Team:	
 	

Staci Ellis, Associate Director Regulatory
	

 	
 	
[*]
	

 	
 	
[*]
	

 	
 	
[*]

i

  

 
 

APPENDIX C TO FIRST AMENDMENT

Appendix C replaces EXHIBIT 17 of the Agreement  

Prices and Price Adjustments  

[*]

	[*]
	 	[*]
	 	[*]

	
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APPENDIX D TO FIRST AMENDMENT continued
  dated 11 June, 2002    

In
the technical protocols [*], the Parties have exchanged a work plan setting forth the development work to which they have
agreed (the "Work Plan"). [*] for the work under the Work Plan are as set forth below in this Appendix D. 

Actimmune—Process
development and scale up 

To
be described in written protocols approved by the Parties 

	
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QuickLinks

FIRST AMENDMENT TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT

APPENDIX TO FIRST AMENDMENT continued dated 11 June, 2002

APPENDIX B TO FIRST AMENDMENT continued dated 11 June, 2002

APPENDIX C TO FIRST AMENDMENT

APPENDIX D TO FIRST AMENDMENT continued dated 11 June, 2002

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00041-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00041-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00041-of-00352.parquet"}]]