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Exhibit 10.213    
    

	 
	 	 

	CONFIDENTIAL	 	REDACTED VERSION

 
 

[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
  OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
  RESPECT TO THE OMITTED PORTIONS.
  
    FDA COMPLIANCE
AGREEMENT    
    

        This FDA Compliance Agreement (the "Agreement") is made and entered into as of June 12, 2003
("Date of Agreement"), by and between: 

        Chiron S.r.l, having its registered office at Via Fiorentina 1, 53100 Siena, Italy; 

and

        Chiron Behring GmbH & Co, with its registered offices at Emil von Behring Strasse 76, 35041 Marburg, Germany, together with Chiron
S.r.l., hereafter referred to as "Chiron"; 

and

        SynCo Bio Partners B.V., having its registered office at Paasheuvelweg 30, 1105 BJ Amsterdam-Zuidoost, The Netherlands, hereinafter
referred to as: "SynCo"; 

WHEREAS:

	A.
	Chiron
has registered and commercially markets its Meningococcal C conjugate vaccine ("Menjugate®") in (parts of) Europe and Canada;

	B.
	At
the request of Chiron, SynCo has manufactured Chiron's MenC polysaccharide ("MenC") and CRM197 ("CRM197") for the European and Canadian market on the basis of that certain contract
manufacturing agreement dated 26 July 2001;

	C.
	Chiron
desires to register and commercially market its Menjugate® in (parts of) the USA;

	D.
	Chiron
has requested SynCo to manufacture as from [***] Chiron's MenC and CRM197 not only for the European,
Canadian market and other international markets, but for the US market as well and with a view thereof, Chiron and SynCo have simultaneously with this agreement entered into that certain contract
manufacturing agreement dated the date hereof (the "New Contract Manufacturing Agreement");

	E.
	With
a view to the registration and launch of Chiron's Menjugate® in the USA and SynCo's manufacturing of Chiron's MenC and CRM197, SynCo's facility at Paasheuvelweg 30 in
Amsterdam-Zuidoost needs to be adjusted so as to fully comply with the requirements of the US Food and Drug Administration ("FDA");

	F.
	An
assessement has been made by Chiron as to the adjustments to be made by SynCo to SynCo's facility at Paasheuvelweg 30 in Amsterdam-Zuidoost so as to fully comply with the
requirements of the FDA;

	G.
	SynCo
has expressed its willingness to manufacture Chiron's MenC and CRM197 for both the European, Canadian and other international markets as well as the US market, provided that
Chiron contributes a certain amount for the adjustments that are required to fully comply with the FDA requirements and for the loss of revenues that will occur during the time that the adjustments to
SynCo's facility will be made;

	H.
	Chiron
and SynCo have agreed on the amount and terms of the contribution to be paid by Chiron to SynCo in respect of the adjustments and on certain other issues; 

 

NOW
THEREFORE, THE PARTIES HAVE AGREED AS FOLLOWS: 

Adjustments to Plant  

	1.
	SynCo
shall make all agreed adjustments to its facility at Paasheuvelweg 30 in Amsterdam-Zuidoost (the "Plant") as described in  Appendix A to this Agreement, which adjustments are identified by the
parties as required by the US Food and Drug Administration ("FDA") to be
made for obtaining the approval of the Plant by the FDA in respect of the registration and launch of Chiron's Menjugate® in the United States of America. However, SynCo does not make, has
not made and shall not be deemed to make or have made any representation, warranty or guaranty as regards the date on which any adjustments are completed or as regards the date on which the FDA
provides its approval to the Plant, if any.

	2.
	In
order to enable SynCo to make the required adjustments, Chiron undertakes that its affiliate Chiron B.V. shall evacuate the so called labelling and packaging area as well as the
former warehouse (such areas sufficiently known to the parties) prior to [***]. Upon evacuation of these areas, the lease
agreement between SynCo and Chiron B.V. shall terminate in respect of these areas.

	3.
	Following
the inspection of the Plant by the FDA and the Plant's subsequent approval by the FDA, SynCo shall, at its own expense, make any and all further adjustments to the Plant
required by the FDA to maintain its approved status as soon as reasonably possible after such requirement has been communicated by the FDA to SynCo.

	4.
	SynCo
shall exercise all reasonable skill, care and diligence in the performance of its duties under this Agreement and shall carry out all responsibilities with recognized
professional standards. 

Contribution by Chiron and Payment thereof  

	5.
	Chiron
shall contribute a total amount of [***] as the only compensation for the agreed adjustments to be made
by SynCo to the Plant and all related necessary validation, qualification and documentation activities to support FDA approval of the Plant. In addition, this amount is to cover any other activities
required of SynCo regarding (i) the preparation of the registration dossier, (ii) resulting from the pre-approval inspection and (iii) all other activities required to
allow the approval of the Plant by the FDA.

	6.
	The
amount referred to in Article 5 of this Agreement does not include a compensation for the performance or documentation of any process and cleaning validations related to the
manufacturing of Chiron's MenC and CRM197 by SynCo or any other person. The cost for the activities and services related to such process and cleaning validations shall be separately invoiced by SynCo
to Chiron, [***], up to but not exceeding [***]. Prior
to the invoicing of any such costs, the parties shall jointly approve in writing a process/cleaning validation protocol setting out the validation activities that SynCo will perform and the timelines
with respect thereto.

	7.
	The
amount of [***] as referred to in the previous paragraph shall be paid upon completion in accordance with
the terms of this Agreement [***] set forth in Appendix B to this
Agreement.

	8.
	Any
and all amounts in this Agreement are to be increased [***].

	9.
	Chiron
and SynCo acknowledge and agree that, although the compensation is calculated on the basis of Chiron's assessment of the adjustments that are required to be made to the Plant
and the loss of revenues that will occur during the time that the adjustments to the Plant will be made, Chiron is not entitled to any documents showing the actual cost incurred by SynCo in this
respect. Although SynCo will use its best efforts to support the approval of the Plant by the FDA, any and all amounts paid by Chiron under this Agreement shall be non-refundable and are
due whether 

2

 

the
registration and/or launch of Chiron's Menjugate in the USA will proceed or not and will not be dependent on the success of such registration and/or launch. 

	9.
	Any
and all amounts to be paid under this Agreement that are not paid at the relevant payment date shall bear interest at a rate of  [***]. Interest shall be compounded on a [***]
. 

FDA Approval Chiron's Responsibility; No Guarantee SynCo  

	10.
	Chiron
acknowledges that it is Chiron's responsibility to obtain approval by the FDA and any other competent regulatory authority with respect to Chiron's Menjugate®.
SynCo's responsibilities are limited to the activities detailed in Article 5 of this Agreement. SynCo does not make and has not made any representations, guarantees or warranties whatsoever,
express or implied, that FDA approval of its Plant will be obtained and SynCo shall not be liable for any direct or indirect damage in the event such approval or any other approval from any other
competent regulatory authority shall not be obtained. 

Entire Agreement  

	11.
	Except
for any provisions relating to the subject hereof in the New Contract Manufacturing Agreement, this Agreement contains the entire understanding and agreement between Chiron and
SynCo relating to the subject matter hereof and supersedes any and all prior arrangements, understandings and agreements relating to the subject matter hereof. 

Amendments in Writing  

	12.
	No
amendments, changes, or modifications of the terms of this Agreement shall be valid or binding unless made in writing and signed by the duly authorized representatives of each of
Chiron and SynCo. 

Law and Arbitration  

	13.
	This
Agreement shall be governed, construed and interpreted by the laws of The Netherlands. Chiron and SynCo agree that any and all disputes between them arising out of or relating to
this Agreement shall be exclusively and finally settled by arbitration in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce by three arbitrators
appointed in accordance with such Rules. The arbitration proceedings shall take place in Amsterdam, The Netherlands, if initiated by Chiron, and in Milan, Italy, if initiated by SynCo, and shall be
conducted in the English language. Judgment on the award may be issued by and enforced by any court of competent jurisdiction. 

Independent Status of Parties.  

	14.
	Each
of Chiron and SynCo is an independent party acting in its own name and for its own account. Neither Chiron nor SynCo has any authority to act as an agent or representative of the
other, or to contract in the name of, or create or assume any obligation against, or otherwise legally bind, the other party in any way for any purpose, unless agreed separately in writing. All costs
and expenses connected with each of the parties' activities and performance under this Agreement unless otherwise separately agreed or provided for in this Agreement are to be borne solely by the
party incurring such costs and expenses. 

No Transfer of Rights or Obligations  

	15.
	Neither
Chiron nor SynCo may transfer any or all of its rights or obligations under this Agreement to any third party, without the prior written consent of the other Party, provided
that SynCo may 

3

 

hire
subcontractors to make any or all of the adjustments to the Plant as provided in this Agreement. 

Press Release  

	16.
	The
parties agree that neither party shall disclose the existence of or the contents of this Agreement to any third party without the prior written consent of the other party. 

        IN
WITNESS WHEREOF, the Chiron S.r.l., Chiron GmbH & Co and SynCo have caused this Agreement to be executed by their duly authorized representatives: 

	Chiron S.r.l.:	 	SynCo Bio Partners B.V.:
	

/s/  JOHN LAMBERT      
 John Lambert
 President, Chiron Vaccines	
 	

/s/  MIC N. HAMERS      
 Dr. Mic N. Hamers
 Managing Director
	
Chiron Behring GmbH & Co:	
 	

 
	

/s/  JOHN LAMBERT      
 John Lambert
 President, Chiron Vaccines	
 	

 

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APPENDIX A
  
    Planned and Agreed Adjustments to the Plant required for FDA Licensure    
    

Objectives  

        The realisation of improvements to Synco's facility at Paasheuvelweg 30 in Amsterdam-Zuidoost (the "Plant") that that are required to be made for the approval of
the Plant by the US Food and Drug
Administration ("FDA") in respect of the registration and launch of Chiron's Menjugate in the United States of America. 

Scope  

        In addition to the activities detailed below the agreed adjustments to the Plant shall be considered to include the activities and all necessary, validation,
qualification and documentation activities required to support FDA licensure of the Plant. Including other activities required of Synco: (i) regarding the preparation of the registration
dossier, (ii) resulting from the pre-approval inspection and (iii) regarding all other activities required to allow the licensing of the Plant by the FDA. The activities are
not considered to include the performance of, or documentation of, any process and cleaning validations related to the manufacturing of Chiron's MenC and CRM197. 

        The
following adjustments which will be will be executed in the first phase of adjustments ("Phase 1") 

	1)
	[***]

	2)
	[***]

	3)
	[***].

	4)
	[***]. 

        The
following adjustments will be will be executed in the second phase of adjustments ("Phase 2") 

	1)
	[***].

	2)
	[***].

	3)
	[***].

	4)
	[***]. 

Planned Timing  

        "Phase 1" of the adjustments to the facility will be executed [***]. The validation of
these adjustments, including all relevant IQ, OQ and PQ reports is planned to be completed within [***]. 

        "Phase
2" of the adjustments to the facility will be executed during [***]. The validation of these adjustments,
including all relevant IQ, OQ and PQ reports is planned to be completed by [***]. 

5

 
 
 

APPENDIX B
  
    Agreed Payment Milestones    
    

        The total amount of [***] will be paid as follows subject to the terms of the FDA
Compliance Agreement: 

[***]. 

[***]. 

[***]. 

[***]. 

[***]. 

[***]. 

[***]. 

        Payment
shall be made by Chiron within thirty (30) days from receipt of the relevant invoice following the agreement of the milestone. 

 
 

[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
  OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
  RESPECT TO THE OMITTED PORTIONS.    
    

6

QuickLinks

Exhibit 10.213

[***]  CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. FDA COMPLIANCE
AGREEMENT

APPENDIX A Planned and Agreed Adjustments to the Plant required for FDA Licensure

APPENDIX B Agreed Payment Milestones

[***]  CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.QuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.321    
    

	CONFIDENTIAL	 	REDACTED VERSION

  
 

    [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
  OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
  RESPECT TO THE OMITTED PORTIONS.    

 
 

BLOOD SCREENING
  
    HCV PROBE LICENSE AGREEMENT—
  
    EUROPEAN UNION
  
    between
  
    CHIRON CORPORATION
  
    F. HOFFMANN-LA ROCHE LTD.
  
    and
  
    ROCHE
MOLECULAR SYSTEMS, INC.    
    

 
 

BLOOD SCREENING HCV PROBE LICENSE AGREEMENT
  
    —EUROPEAN UNION
  TABLE OF CONTENTS    
    

	 
	 	 
	 	Page

	RECITALS	 	 	 	1
	

ARTICLE 1	
 	

DEFINITIONS	
 	

1
	

ARTICLE 2	
 	

LICENSE AND OPTION GRANTS	
 	

5
	

ARTICLE 3	
 	

PAYMENTS, ROYALTIES	
 	

7
	

ARTICLE 4	
 	

RECORDS AND REPORTS	
 	

7
	

ARTICLE 5	
 	

OTHER ACTIONS	
 	

9
	

ARTICLE 6	
 	

REPRESENTATIONS AND WARRANTIES	
 	

10
	

ARTICLE 7	
 	

TERM AND TERMINATION	
 	

11
	

ARTICLE 8	
 	

CONFIDENTIALITY	
 	

13
	

ARTICLE 9	
 	

INDEMNITY	
 	

14
	

ARTICLE 10	
 	

ALTERNATIVE DISPUTE RESOLUTION	
 	

15
	

ARTICLE 11	
 	

MISCELLANEOUS	
 	

16
	

ARTICLE 12	
 	

FIELD RESTRICTIONS AND OTHER COVENANTS	
 	

18
	

ARTICLE 13	
 	

INFRINGEMENT BY THIRD PARTIES	
 	

19
	

ARTICLE 14	
 	

EUROPEAN COMMUNITY PROVISIONS	
 	

21
	

EXHIBIT A	
 	

COMPENSATION TO CHIRON	
 	

 
	

EXHIBIT B	
 	

CHIRON PATENT LIST	
 	

 
	

EXHIBIT C	
 	

ROCHE PATENT LIST	
 	

 
	

EXHIBIT D	
 	

CHIRON LICENSED PRODUCTS	
 	

 
	

EXHIBIT E	
 	

FORM OF REPORT	
 	

 
	

EXHIBIT F	
 	

EXISTING LICENSES	
 	

 

 
 
 

BLOOD SCREENING HCV PROBE LICENSE AGREEMENT—EUROPEAN UNION    
    

        This agreement (hereinafter "Agreement") is made by and between CHIRON CORPORATION, a Delaware corporation, of 4560 Horton Street, Emeryville, California 94608
(hereinafter referred to as "CHIRON"), F. HOFFMANN-LA ROCHE LTD., a Swiss corporation, of Grenzacherstrasse 124, Basel, Switzerland (hereinafter referred to as "ROCHE PARENT"), and
ROCHE MOLECULAR SYSTEMS, INC., a Delaware corporation, of 1145 Atlantic Avenue, Suite 100, Alameda, California 94501 (hereinafter referred to as "RMS" and collectively with ROCHE PARENT,
"ROCHE"). 

 
 

BACKGROUND    
    

        WHEREAS, CHIRON and ROCHE currently own or control certain patent rights relating to the hepatitis C virus ("HCV'), as defined below. 

        WHEREAS,
CHIRON and ROCHE entered into that certain Settlement Agreement dated as of October 10, 2000 (the "Settlement Agreement") pertaining to the settlement of the certain
litigation matters described therein. 

        WHEREAS,
in consideration of and subject to the execution and delivery of the Settlement Agreement, CHIRON granted licenses to ROCHE under certain patent rights relating to HCV for use
in assays for the detection of nucleic acid sequences for use in Blood Screening, under that certain Blood Screening HCV Probe License Agreement dated as of January 1, 2001 (the "Original
License Agreement"). 

        WHEREAS,
the parties wish to amend the Original License Agreement by entering into a separate license agreement containing terms and conditions mutually agreed upon by the parties for
the region of the European Union, all on the terms and conditions set forth herein. 

        NOW,
THEREFORE, in consideration of the above provisions and the mutual covenants contained herein, CHIRON and ROCHE hereby agree as follows: 

 
 

ARTICLE 1
  DEFINITIONS    
    

        In this Agreement the following words and phrases shall have the following meanings: 

        1.1    "ADR"
means Alternative Dispute Resolution in accordance with Article 10. 

        1.2    "Affiliate"
means an entity that directly, or indirectly through one or more intermediaries, controls or is controlled by or is under common control with, a specified
entity. For the purposes of this definition, "control" (including with correlative meanings, the terms "controlling", "controlled by" and "under common control with"), as applied to any entity, means:
(a) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of that entity, whether through the ownership of voting securities or by
contract or otherwise; or (b) the ownership of at least fifty percent (50%) of the voting securities of that entity. Notwithstanding anything to the contrary contained herein, "Affiliate" shall
not include, in the case of CHIRON, Novartis AG or any Affiliate of Novartis AG, unless Novartis shall have acquired direct control of a majority of the Board of Directors of CHIRON. Notwithstanding
anything to the contrary contained herein, Affiliate" shall not include, in the case of ROCHE, Genentech Inc. or any Affiliate of Genentech Inc., nor Chugai Pharmaceutical
Co., Ltd., or any Affiliate of Chugai Pharmaceutical Co., Ltd. 

        1.3    "Authorized
Distributor" means a bona fide, unaffiliated distributor, but excluding any entity which is a Major IVD
Manufacturer (as defined below) that is not licensed in the Field (as defined below) under one or more of the CHIRON Licensed Patents (as defined below) or is affiliated with, or directly or
indirectly controlled by, such a Major IVD Manufacturer, except to 

1

 

the
extent that such unlicensed Major IVD Manufacturer or its Affiliates distributes CHIRON Licensed Products for ROCHE or its Affiliates on a local country basis and in the same manner in which it
distributes other diagnostic products for ROCHE or its Affiliates and ROCHE and its Affiliates are not otherwise selling CHIRON Licensed Products in such country. 

        1.4    "Blood
Screening" means the commercial use of products that detect nucleic acid sequences(s) for: (a) the screening of blood, plasma or blood components intended
for transfusion; and (b) confirmatory
or supplemental testing of the same samples otherwise screened for purposes described in Section 1.4(a). 

        1.5    "Calendar
Quarter" means the three (3) month period beginning January 1, April 1, July 1 or October 1. 

        1.6    "Calendar
Year" means January 1 through December 31. 

        1.7    "CHIRON
Future HCV Sequence Patent Rights" means any and all Valid Claims Directed to HCV of United States and foreign patents and patent applications: (a) which
are based upon inventions conceived or rights acquired [***] (as defined below); (b) are not CHIRON Licensed Patents (as
defined below); (c) which claim HCV nucleic acid sequence(s) or a method to use (other than in the manufacture of peptides) or detect such sequences specifically; (d) which are owned by,
licensed to or otherwise controlled by CHIRON or its Affiliates, with rights to license or sublicense; and (e) with respect to which CHIRON has the right to grant the option provided for in
Section 2.4 of this Agreement. For purposes of this Agreement, an invention will be deemed to have been conceived if there is a patent, patent application, written invention disclosure
statement or other tangible document (whether or not witnessed) describing such invention. 

        1.8    "CHIRON
Licensed Patents" means Valid Claims Directed to HCV which cover the manufacture, use, sale, offer for sale or importation of Products that are contained within
any of the following: (a) the patents and applications identified in Exhibit B and any continuation, continuation-in-part and divisional applications therefrom;
(b) any reissued or reexamined patents obtained from such patents and applications; (c) all foreign counterparts of such patents and applications; and (d) all future patents and
applications which are based on inventions conceived by CHIRON or its Affiliates on or before the Effective Date. 

        1.9    "CHIRON
Licensed Products" means current and future Products which are manufactured, used, offered for sale, imported or sold under circumstances which would, in the
absence of the license granted under Section 2.1 constitute an infringement of a Valid Claim of the CHIRON Licensed Patents, including without limitation the Products identified in
Exhibit D, as modified from time to time by mutual agreement of the parties. 

        1.10    "CHIRON
Non-HCV/HIV Analyte Patent Rights" means any and all Valid Claims of U.S. and foreign patents and patent applications: (a) which claim any
nucleic acid sequence(s) or transmissible disease-causing agent(s), other than HCV or HIV; (b) which is a blood borne, infectious disease or virus to the extent such Valid Claims cover the
detection of any nucleic acid sequence(s) or transmissible disease-causing agent(s) of such infectious disease or virus; (c) which are owned by, licensed to or otherwise controlled by CHIRON or
its Affiliates, with right to license or sublicense and (d) with respect to which CHIRON has the right to grant the option provided for in Section 2.4 of this Agreement. 

        1.11    "CHIRON
Optioned Rights" means the CHIRON Future HCV Sequence Patent Rights and the CHIRON Non-HCV/HIV Analyte Patent Rights. 

        1.12    "Cross
Sales or "Cross Selling" shall have the meaning specified in Section 12.3. 

        1.13    "Cross
Seller" means an End User that is engaged in Cross Selling. 

2

 

        1.14    "Directed
to HCV" means that the claim or technology in question is directed to methods, compositions, reagents or kits specifically for use in nucleic
acid-based diagnostic assays for the detection of HCV nucleic acid sequence(s), or specifically for use in the manufacture of any compositions or reagents for use in, or manufacture of
nucleic acid-based diagnostic assays for detection of HCV nucleic acid sequence(s) (excluding, for example, PCR claims and technology and other methods for detection of nucleic acid
sequence(s) generally which involve nucleic acid amplification). The terminology "specifically for use" as used in this Section 1.14, is intended to exclude inventions suitable for use with
viruses or analytes other than HCV (including by way of example and not by way of limitation, inventions relating to PCR, or assay formats, improved expression systems, detectable labels,
instrumentation, packaging and the like), which shall not be considered "specifically for use" in HCV detection as contemplated by this Section 1.14 and shall therefore not be considered as
"Directed to HCV" hereunder. 

        1.15    "Earned
Royalty" and "Earned Royalty Amount" shall have the meanings specified in Paragraph 1 of Exhibit A. 

        1.16    "Effective
Date" means [***]. 

        1.17    "End
User" means a person or entity who is a final purchaser of a Product, and whose use of a Product results in the Product's consumption, operation, destruction or
loss of activity. 

        1.18    "Field"
means Blood Screening and Plasma Fractionation. 

        1.19    "Foundational
Patents" means the CHIRON Licensed Patents identified in Exhibit B which are stated therein to be Foundational Patents. 

        1.20    "HCV"
means any viral isolate of the hepatitis C virus described in the CHIRON Licensed Patents or classified as HCV by the International Committee on the Taxonomy of
Viruses (or any body that replaces such Committee) or any subtype of such isolate and further includes any isolate that is at least forty percent (40%) homologous to any such isolate and of the same
genomic type and substantially the same genomic organization, any isolate that has a genome that either hybridizes to or is substantially identical to any such isolate or its compliment, and any
defective or modified form of any of the above isolates. 

        1.21    "HCV
Diagnostics Agreements" means the HCV Probe License and Option Agreement—European Union by and between CHIRON and ROCHE, dated as of the Effective
Date, and the HCV Probe License and Option Agreement by and between CHIRON and ROCHE, dated as of October 10, 2000, each as amended from time to time. 

        1.22    "Infringing
Third Party Sales" means (a) as to Blood Screening, sales by a Major IVD Manufacturer of Products for use in Blood Screening, and (b) as to
Plasma Fractionation, sales or use by any third party for use in Plasma Fractionation, which in either case: (i) infringe one or more of the CHIRON Licensed Patents, or (b) as to which a
license under one or more of the CHIRON Licensed Patents has been granted, but as to which the licensee is not paying royalties thereunder. 

        1.23    "In Vitro Diagnostics" means the commercial use of products that detect nucleic acid sequence(s) of HCV in individual
human specimens, including the use of such products for diagnosis, prognosis, monitoring or classification purposes, including without limitation use for Transplantation but specifically excluding use
for Blood Screening and Plasma Fractionation (without prejudice to the provisions of the HCV Diagnostics Agreements). 

        1.24    "In Vitro Diagnostics End User" means an entity that purchases CHIRON Licensed Products for the primary purpose of  In Vitro Diagnostics. 

3

 

        1.25    "Licensed/Optioned
Patents" means the CHIRON Licensed Patents and the ROCHE Optioned Patents. 

        1.26    "Major
IVD Manufacturer" means a commercial entity (and its Affiliates) that manufactures, sells and engages in other commercial activities with respect to  In Vitro Diagnostic products and has a significant
marketing presence in the Region. Major IVD Manufacturers include Abbott, Bayer, Johnson &
Johnson, Pasteur, Sanofi, Dade Behring, Organon Teknika, Becton Dickinson, bioMerieux,
BioRad, Fujirebio, Beckman Coulter, Visible Genetics, Innogenetics, and PE Corporation and each of their successors and assigns and any other entity which commands in the future at least an equivalent
presence as measured by total product sales as do any of the foregoing entities as of the Effective Date in the Region. 

        1.27    "Passive
Sales" or "Passive Selling" means [***] for the purchase of CHIRON Licensed Product for
use outside of the Field. 

        1.28    "PCR"
means polymerase chain reaction technology. 

        1.29    "Plasma
Fractionation" means the commercial use of products that detect HCV nucleic acid sequence(s) for the screening of plasma or blood components intended for use in
blood products (e.g., without limitation, immunoglobulins). 

        1.30    "Product(s)"
means reagents, compositions or kits suitable for use in the Field. 

        1.31    "Region"
shall mean, with respect to any Calendar Quarter, all member states whose accession to the European Union has become effective on or before the first day of
each such Calendar Quarter. 

        1.32    "Registration"
means a filing with respect to the commercial sale of the CHIRON Licensed Products made with any governmental or regulatory body or other body having
authority over the commercial sale of the CHIRON Licensed Products, made [***] of this Agreement in any country located within,
or covering all of the countries within, the Region including, without limitation, applications for registration under the CE mark. 

        1.33    "Release
Screening" means, as to Plasma Fractionation only, the quality control testing of plasma samples that have previously been screened for the presence of HCV
using (a) a CHIRON Licensed Product for which at least the applicable Earned Royalty Amount has been paid, (b) any other Product for the detection of HCV licensed by CHIRON for sale or
use in Plasma Fractionation or (c) a Product sold or used by CHIRON for the detection of HCV. 

        1.34    "ROCHE
Future HCV Sequence Patent Rights" means any and all Valid Claims Directed to HCV of United States and foreign patents and patent applications: (a) which
are based on inventions conceived or rights acquired [***]; (b) are not ROCHE Optioned Patents (as defined below);
(c) which claim HCV nucleic acid sequence(s) or a method to use (other than in the manufacture of peptides) or detect such sequences specifically; (d) which are owned by, licensed to or
otherwise controlled by ROCHE or its Affiliate, with rights to license or sublicense; and (e) with respect to which ROCHE has the right to grant the option provided for in Section 2.5 of
this Agreement. For
purposes of this Agreement, an invention will be deemed to have been conceived if there is a patent, patent application, written invention disclosure statement or other tangible document (whether or
not witnessed) describing such invention. 

        1.35    "ROCHE
Non-HCV/HIV Analyte Patent Rights" means any and all Valid Claims of U.S. and foreign patents and patent applications: (a) which claim any
nucleic acid sequence(s) or transmissible disease-causing agent(s), other than HCV or HIV; (b) which is a blood borne, infectious disease or virus to the extent such Valid Claims cover the
detection of any nucleic acid sequence(s) or transmissible disease-causing agent(s) of such infectious disease or virus; (c) which are owned by, licensed to or otherwise controlled by ROCHE or
its Affiliates, with right to license 

4

 

or
sublicense; and (d) with respect to which ROCHE has the right to grant the option provided for in Section 2.5 of this Agreement. 

        1.36    "ROCHE
Optioned Patents" means: (a) the patents and applications identified in Exhibit C and any continuation,
continuation-in-part and divisional applications therefrom; (b) any reissued or reexamined patents obtained from such patents and applications; (c) all foreign
counterparts of such patents and applications; and (d) all future patents and applications which are based on inventions conceived by ROCHE or its Affiliates  [***], to the extent the items
described in clauses (a) through (d) of this Section 1.36 contain a Valid
Claim Directed to HCV which covers the manufacture, use, sale, offer for sale or importation of a product in the Field or in Transplantation. 

        1.37    "ROCHE
Optioned Product" means a Product which is manufactured, used, offered for sale, imported or sold under circumstances which would, in the absence of the license
for which an option is granted under Section 2.3, constitute an infringement of a Valid Claim of the ROCHE Optioned Patents. 

        1.38    "ROCHE
Optioned Rights" means the ROCHE Future HCV Sequence Patent Rights and the ROCHE Non-HCV/HIV Analyte Patent Rights. 

        1.39    "Term"
has the meaning set forth in Section 7.1. 

        1.40    "Transplantation"
means the commercial use of products that detect nucleic acid sequences for the screening of any biological materials intended for transfusion or
transplantation, in each case from any donor, including autologous donors, other than the transfusion or transplantation of blood or its derivatives, components or replacements. 

        1.41    "Units"
means the number of individual donations of blood, plasma or other blood components that are tested for Blood Screening by End Users through the use of a CHIRON
Licensed Product. In the event that ROCHE or its Affiliates perform assays for commercial purposes utilizing CHIRON Licensed Product, Units shall include the number of individual donations of blood,
plasma or other blood components that are so tested by ROCHE or its Affiliates. Notwithstanding the foregoing, Units shall not include those CHIRON Licensed Products used by or for End Users at no
charge by ROCHE for (A) reasonable quantities of quality control or evaluation testing or (B) replacement of defective goods. In the case of pooled blood samples tested through the use
of a CHIRON Licensed Product, "individual donations of blood" refers to each individual donation of blood, plasma or other blood components that is represented in the tested pool, regardless of the
number of times such donation is tested. 

        1.42    "Valid
Claim" means a claim in any issued, active, unexpired patent which has not been withdrawn, cancelled, lapsed or disclaimed, or held unpatentable, invalid or
permanently unenforceable by a non-appealed or nonappealable final decision by a court or other appropriate body of competent jurisdiction. The scope of a Valid Claim shall be limited to
its terms as defined by any such court or decision-making body of competent jurisdiction in a nonappealable or non-appealed final decision. 

 
 

ARTICLE 2
  LICENSE AND OPTION GRANTS    
    

        2.1    CHIRON Grants.    Subject to the terms and conditions of this Agreement, CHIRON hereby grants to ROCHE and its
Affiliates, so long as they remain Affiliates of ROCHE, a nonexclusive license, without the right to sublicense except to have made or to conduct research, under the CHIRON Licensed Patents to
research, develop, make, have made, import, use, offer for sale and sell CHIRON Licensed Products within the Region for use in the Field and, to the extent permitted in Section 12, for use
outside of the Field. CHIRON covenants not to sue any End User of a CHIRON 

5

 

Licensed
Product (with respect to which ROCHE has performed all of its material obligations under this Agreement) to the extent of activities in the Field, outside of the Field (to the extent provided
in Section 12) or as otherwise permitted under this Agreement. Conversely no immunity from suit shall apply to End User activities in In Vitro
Diagnostics, or otherwise outside of the Field, except as otherwise provided in this Agreement or as provided in the HCV Diagnostics Agreements. Subject to Paragraph 4 of Exhibit A,
CHIRON retains the nonexclusive right to practice and to grant licenses under the CHIRON Licensed Patents to make, have made, use, import, offer for sale and sell any Products in the Field and all
rights outside of the Field. 

        2.2    Exclusion from CHIRON License.    ROCHE acknowledges that neither ROCHE nor its Affiliates are licensed under
this Agreement to perform research or to develop any product other than a CHIRON Licensed Product. 

        2.3    ROCHE Optioned Patents.    Subject to the terms and conditions this Agreement, ROCHE hereby grants to CHIRON
and its Affiliates, so long as they remain Affiliates of CHIRON, an option to enter into a non-exclusive, [***]
license, with no right to sublicense except to have made or to conduct research, under ROCHE Optioned Patents to research, develop, make, have made, import, use, offer for sale and sell ROCHE Optioned
Products within the Region for use in the Field and in Transplantation. 

        2.4    CHIRON Optioned Rights.    CHIRON grants to ROCHE a nonexclusive option to obtain one or more nonexclusive,
licenses, or sublicenses, as the case may be, with a right to sublicense to ROCHE Affiliates only, under the CHIRON Optioned Rights, to make, have made, use, import, offer for sale and sell CHIRON
Licensed Products and/or products within the Region in the Field and in Transplantation (including as to CHIRON Non-HCV/HIV Analyte Patent Rights products for the detection of other
transmissible disease-causing agents). [***]. 

        2.5    ROCHE Optioned Rights.    ROCHE grants to CHIRON a nonexclusive option to obtain one or more nonexclusive,
licenses, or sublicenses, as the case may be, with a right to sublicense to CHIRON Affiliates only, under the ROCHE Optioned Rights, to make, have made, use, import, offer for sale and sell products
within the Region in the Field and in Transplantation (including as to ROCHE Non-HCV/HIV Analyte Patent Rights products for the detection of other transmissible disease-causing agents).  [***].

        2.6    Option Terms.    As to any Valid Claim(s) included within CHIRON Optioned Rights or ROCHE Optioned Rights, the
options set forth in Sections 2.4 and 2.5 may be exercised at any time [***] during the life of such patent(s), by written
notice from the option grantee to the option grantor identifying the patent(s) under which the grantee wishes to obtain a license;  [***]. The terms of such license agreement will be subject to the
following: 

        (a)    [***];    

        (b)    [***];    

        (c)    [***];    

        (d)    The
licensee will be able to terminate the license agreement at any time by giving the licensor prior written notice; 

        (e)    The
licensee will not have any right of enforcement, and will not receive from the licensor any warranty of validity or noninfringement; provided, however, the licensor
shall disclose to the licensee prior to entering into such license, any knowledge it has of any pending or written threatened claim that is material to any challenge of validity or enforceability,
except to the extent that such disclosure is subject to an obligation of confidentiality, protective order or legal privilege; and 

6

 

        (f)    [***].    

        2.7    Need for Option.    CHIRON may, at any time hereunder, provide written notification to ROCHE that certain
products being sold or used by ROCHE within the Region are believed by CHIRON to be covered by one or more Valid Claims of a patent included within CHIRON Optioned Rights not licensed to ROCHE. In the
event ROCHE does not, [***] days of receipt of such notification, exercise the relevant option provided for under
Section 2.4 to obtain a license under such CHIRON Optioned Right, then CHIRON and ROCHE shall promptly thereafter confer in good faith to discuss their respective positions concerning whether
such products being sold or used by ROCHE within the Region are covered by a Valid Claim of the patent in question. If within ninety (90) days following the above-mentioned notification,  [***].

        2.8    Option Exercise.    [***]. 

        2.9    Effect on Option by Termination.    Termination of this Agreement pursuant to Article 7 shall terminate
the provisions of Sections 2.3 to 2.9; provided, however, that if at the time of such termination or, if prior notification is required under Section 7.3, then if immediately prior to the
effective date of termination set forth in such notification: (a) a license agreement arising out of the options granted under Section 2.3, 2.4 or 2.5 is in effect, such license shall
survive such termination under Article 7 and shall remain in effect in accordance with its terms; or (b) a party has properly exercised an option pursuant to Section 2.3, 2.4 or
2.5 and is proceeding in good faith to negotiate a license agreement thereunder, the parties shall complete such negotiations in good faith. 

        2.10    Third Party Patents.    Each party shall use reasonable commercial efforts to acquire the right to grant the
options provided in Sections 2.4 and 2.5 when it acquires rights under patents of third parties. 

 
 

ARTICLE 3
  PAYMENTS, ROYALTIES    
    

        With respect to all Units, ROCHE shall make payments to CHIRON as set forth in Exhibit A. 

 
 

ARTICLE 4
  RECORDS AND REPORTS    
    

        4.1    Units Data.    ROCHE shall use commercially reasonable efforts to collect Units data for each Calendar Quarter
from End Users in such detail and accuracy so as to enable a determination of the amounts payable by ROCHE to CHIRON hereunder. In the event an End User fails to timely report its Units data for a
Calendar Quarter to ROCHE, ROCHE shall include in the report for such Calendar Quarter required under Section 4.2 a reasonable estimate of the number of such Units, subject to a "true up"
correction in the subsequent Calendar Quarter. [***]. 

        4.2    Earned Royalty Report.    ROCHE shall, within ninety (90) days after the last day of each Calendar
Quarter commencing on or [***], deliver to CHIRON a true and accurate report for the prior Calendar Quarter, substantially in
the form attached as Exhibit E to this Agreement, which shall state the amount of monies due hereunder if any, as Earned Royalties, and shall include all information reasonably necessary to
calculate such amount, including, but not limited to, the following information, presented for the Region by Product and Field Category (as defined in Paragraph 1 of Exhibit A): 

        (a)   the
number of Units and the applicable Earned Royalty Amounts, together with any "true-up" adjustments to (i) Units from prior Calendar Quarters
(e.g., late reporting End Users) or (ii) the estimate of Earned Royalties paid pursuant to Section 4.3; and 

7

 

        (b)   a
statement of the basis for any deviation from the Earned Royalty rates and Earned Royalty Amounts as expressed in Paragraphs 1 and 2 of Exhibit A. 

Upon
written request by CHIRON, ROCHE will annotate and redeliver to CHIRON any Earned Royalty Report four (4) or more Calendar Quarters old to include Units and Earned Royalty Amount on a
country-by-country basis with respect to each country located in the Region. 

        4.3    Payment Dates.    Not later than seventy-five (75) days after the last day of each Calendar
Quarter commencing on or [***], ROCHE shall pay to CHIRON a good faith estimate of the Earned Royalty for such Calendar Quarter
due under this Agreement. Such good faith estimate shall be based on the most recent Units data available to ROCHE, together with such reasonable growth and seasonality assumptions utilized by ROCHE
for internal planning purposes. If no Earned Royalties are due, ROCHE shall so report, stating the reasons why no such royalty is due. Not later than the date each Earned Royalty Report required under
Section 4.2 is due, ROCHE shall "true-up" its estimated Earned Royalty payment based on the number of Units set forth in the Earned Royalty Report for such Calendar Quarter and, if
it is determined that the estimate of Earned Royalties paid was less than the amount actually due for such Calendar Quarter, pay the underpaid amount, plus interest at the rate described in
Section 4.9. If it is determined that the estimate of Earned Royalties paid was more than the amount actually due for such Calendar Quarter, such overpaid amount shall be credited against
Earned Royalties payable on Units in the subsequent Calendar Quarter, plus interest at the rate described in Section 4.9. 

        4.4    Payment Procedures.    ROCHE shall pay royalties and all other payments due hereunder to CHIRON in immediately
available funds on the due date by wire transfer to: 

Bank
of America-San Francisco

San Francisco, California

Account Name: Chiron Corporation

Account Number: [***]

ABA#: [***]

Reference: ROCHE Blood Screening HCV Probe License Agreement 

or
at such place and in such other manner as CHIRON may designate in a notice signed by CHIRON's Treasurer or Controller to ROCHE. 

        4.5    Taxes on Royalties.    ROCHE shall deduct from amounts payable hereunder all taxes assessed or imposed against,
or required to be withheld from, royalty payments due and shall pay such amount to the appropriate fiscal or tax authorities on behalf of CHIRON. ROCHE shall forward promptly to CHIRON all tax
receipts received by ROCHE evidencing payment of such taxes. 

        4.6    Audit Rights.    

        (a)    End Users.    ROCHE shall use commercially reasonable efforts to include sufficient audit rights in all
agreements with End Users of CHIRON Licensed Products to enable ROCHE to confirm the validity of such End Users' periodic Units data. Upon thirty (30) days written notice by CHIRON, not more
frequently than once per Calendar Year and either in conjunction with an audit permitted under Section 4.6(c) or not within the same Calendar Year as such an audit, CHIRON may have such End
User agreements examined during reasonable business hours by a mutually acceptable independent certified public accountant selected by CHIRON and at CHIRON's expense, whose acceptance shall not
unreasonably be withheld by ROCHE, for the purpose of verifying the existence of such audit rights; provided that such independent accountant agrees to provide CHIRON only the information necessary to
verify the existence of such audit rights without the disclosure of any End User identity and provided further, that ROCHE may propose an alternative methodology of confirming to CHIRON the validity
of such End Users' 

8

 

periodic
Units data, subject to CHIRON's prior written consent, which may not be unreasonably withheld. 

        (b)    Earned Royalties.    ROCHE shall keep reasonably detailed and accurate records and books of account, including
without limitation retaining all End User Units data and End User audit materials, to enable a determination of the amounts payable by ROCHE and its Affiliates to CHIRON hereunder. Upon thirty
(30) days written notice by CHIRON, not more frequently than once per Calendar Year and either in conjunction with an audit permitted under Section 4.6(a) or not within the same Calendar
Year as such an audit, CHIRON may have such records and books of account examined during reasonable business hours by a mutually acceptable independent certified public accountant selected by CHIRON
and at CHIRON's expense, whose acceptance shall not unreasonably be withheld by ROCHE, for the purpose of verifying the amounts due hereunder; provided that such independent accountant agrees to
provide CHIRON only the information necessary to verify the calculation of amounts due hereunder. A copy of any final written report provided by the independent accountant to CHIRON shall be given
concurrently to ROCHE. Such examination shall not be permitted unless it is requested within three (3) years following the end of the Calendar Year to which the books and records pertain. Where
such examination results in a finding that ROCHE underpaid CHIRON by the greater of [***], ROCHE shall reimburse CHIRON for its
reasonable costs and expenses in conducting such examination. ROCHE and CHIRON shall promptly rectify any overpayments or underpayments by repaying such amounts together with interest thereon at an
annual rate equal to the lesser of: (a) [***] published in the Wall Street Journal, or (b) the maximum rates
permitted by applicable law, from the time such payment was originally due to the time it is paid. 

        4.7    Confidentiality of Audit.    CHIRON agrees that all audited information shall be confidential to ROCHE and its
Affiliates, and that any person or entity conducting an audit on behalf of CHIRON pursuant to Section 4.6 shall be required to protect the confidentiality of such information. 

        4.8    Payment in United States Currency.    All payments shall be made in United States Dollars and shall be made on
the dates set forth herein. 

        4.9    Late Payment Fee.    Any payment, including, without limitation, royalty payments, made by ROCHE hereunder
after the date such payment is due, as set forth in this Article 4 hereof, shall bear interest at the lesser of:
(a) [***] as published in the Wall Street Journal as of the date such payment was due, or (b) the maximum rate
permitted by applicable law. 

 
 

ARTICLE 5
  OTHER ACTIONS    
    

        5.1    Patent Validity; Enforceability.    ROCHE represents and warrants that, on or before the Effective Date and
consistent with the Settlement Agreement, it has discontinued any opposition, challenge, compulsory license application or the like with respect to the CHIRON Licensed Patents within the Region.
CHIRON represents and warrants that, on or before the Effective Date and consistent with the Settlement Agreement, it has discontinued any opposition, challenge, compulsory license application or the
like with respect to the ROCHE Optioned Patents within the Region. 

        5.2    Compulsory Licensing.    ROCHE covenants and agrees on behalf of itself and its Affiliates to not support any
third party in seeking compulsory licensing of the CHIRON Licensed Patents in the Region. As used in this Section, "support" shall have the same meanings as in Section 7.2(b). 

        5.3    Registrations.    Notwithstanding the provisions of Section 12.1 of this Agreement or
Section 12.1 of the HCV Diagnostics Agreements, ROCHE or any of its Affiliates may elect, at any time during the Term, in its sole discretion and at its sole cost and expense, to seek a
Registration, or to provide assistance to a third party in such third party's seeking a Registration, of a CHIRON 

9

 

Licensed
Product [***]. If ROCHE or an Affiliate of ROCHE files a Registration, or provides substantial assistance to a third
party for such third party's Registration, [***] then ROCHE or the applicable ROCHE Affiliate will promptly inform CHIRON in
writing of the existence and subject matter of such Registration. CHIRON acknowledges and agrees that ROCHE's or any ROCHE Affiliate's election to seek (or assist a third party in seeking) any such
Registration outside of the Field (absent other labeling or promoting activities by ROCHE or such ROCHE Affiliate which would independently fall outside of the definition of Passive Selling) will
constitute Passive Selling for purposes of this Agreement. [***]

 
 

ARTICLE 6
  REPRESENTATIONS AND WARRANTIES    
    

        6.1    Corporate Authority.    Each party represents and warrants to the other party that it has the necessary
corporate authority to enter into this Agreement. 

        6.2    Right to Grant.    Each party represents and warrants that they have the right to grant the licenses and
options granted in Article 2 hereof and that they are the sole owner of their respective Licensed/Optioned Patents, subject to licenses existing as of the Effective Date. CHIRON represents and
warrants to ROCHE that, to the best of its knowledge, neither CHIRON nor any of its Affiliates have transferred to [***] or any
of its Affiliates (a) before December 1, 1998, title to any patent or patent application Directed to HCV in the Field existing on that date; or (b) on or after that date, title to
any patent, patent application or invention Directed to HCV in the Field. 

        6.3    Current Licenses.    CHIRON represents and warrants that: (a) as of the Effective Date the entities set
forth in Exhibit F are the only parties to which it has granted any licensed rights or other grants or immunities to one or more of the CHIRON Licensed Patents in the Field; and
(b) Exhibit F contains a complete and accurate description of the effective scope, field and territory of such grant as of the Effective Date. CHIRON also represents and warrants that  [***]
except as disclosed in Exhibit F. 

        6.4    Complete Patent List.    CHIRON represents and warrants to ROCHE that, to the best of its knowledge and belief,
Exhibit B contains a complete list, as of the Effective Date, of all patents and patent applications owned by, licensed to (with a right to sublicense), or otherwise controlled by CHIRON or its
Affiliates containing claims Directed to HCV in the Field in any country located in the Region. To the extent that any other patent or patent application owned by, licensed to (with a right to
sublicense) or otherwise controlled by CHIRON or its Affiliates and filed on or before the Effective Date contains a claim Directed to HCV in the Field in any country located in the Region, such
patent or patent application shall be automatically added to the CHIRON Licensed Patents. Upon ROCHE's written request, not more frequently than annually, CHIRON shall provide ROCHE with an updated
Exhibit B and a report of the prosecution status of applications within CHIRON Licensed Patents. ROCHE represents and warrants to CHIRON that, to the best of its knowledge and belief,
Exhibit C contains a complete list, as of the Effective Date, of all patents and patent applications owned by, licensed to (with a right to sublicense), or otherwise controlled by ROCHE or its
Affiliates containing claims Directed to HCV in the Field in any country located in the Region. To the extent that any other patent or patent application owned by, licensed to (with a right to
sublicense) or otherwise controlled by ROCHE or its Affiliates and filed on or before the Effective Date contains a claim Directed to HCV in the Field in any country located in the Region, such patent
or patent application shall be automatically added to the ROCHE Optioned Patents. Upon CHIRON's written request, not more frequently than annually, ROCHE shall provide CHIRON with an updated
Exhibit C and a report of the prosecution status of applications within ROCHE Optioned Patents. 

10

 

        6.5    Exclusions.    Nothing contained in this Agreement shall be construed as: 

        (a)   A
representation or warranty by any party hereto as to the validity of any patent rights which are the subject of this Agreement; 

        (b)   A
representation or warranty that anything made, used, imported, offered for sale, sold or otherwise disposed of under any of the patent rights which are the subject of
this Agreement is or will be free from infringement of patents of third parties or of patents of either party that are not Directed to HCV; 

        (c)   An
obligation to bring or prosecute actions or suits against third parties for infringement of any patent rights which are the subject of this Agreement; 

        (d)   A
grant of any right to bring or prosecute actions or suits against third parties for infringement of any patent rights which are the subject of this Agreement; or 

        (e)   A
grant, by implication, estoppel or otherwise, of any license, option, covenant or right other than those which are expressly stated herein, including without
limitation (i) any license under any patent or patent application (or claim thereof) not within the Licensed/Optioned Patents, or (ii) any covenant by CHIRON or ROCHE not to sue under
any such patent or patent application (or claim thereof). 

        6.6    Further ROCHE Assurance.    ROCHE acknowledges that the inclusion of ROCHE Affiliates within the license and
option grants pursuant to Sections 2.1 and 2.4 is intended to enable ROCHE to utilize the manufacturing and sales capabilities of its Affiliates in connection with the manufacture and sale of CHIRON
Licensed Products in a manner substantially similar to the involvement of such Affiliates in the manufacture and sale of ROCHE's products generally. ROCHE shall not, directly or indirectly, take any
action having or intended to have the effect of sublicensing ROCHE's rights under any of the CHIRON Licensed Patents, other than to a bona fide Affiliate, including, without limitation, by creating
Affiliates specifically in connection with CHIRON Licensed Products, or through other third party arrangements such as joint ventures, collaborations, or distribution arrangements with distributors.
ROCHE and its Affiliates are licensed hereunder to sell and distribute CHIRON Licensed Products only under the label, name and trademark rights owned by, licensed to or otherwise controlled by ROCHE
or its Affiliates, and only through the sales force of ROCHE or its Affiliates, or through Authorized Distributors or Cross Sellers (subject to Section 12). ROCHE and its Affiliates are not
licensed to perform OEM manufacturing of CHIRON Licensed Products for a third party other than an Authorized Distributor or a Cross Seller (subject to Section 12); to supply CHIRON Licensed
Products for resale to any third party other than an Authorized Distributor or a Cross Seller (subject to Section 12); to permit any Authorized Distributor or other third party to sell any
CHIRON Licensed Products under another third party label, name or trademark or to permit any Authorized Distributor or other third party to sell any CHIRON Licensed Products under the Authorized
Distributor's or any third party's own label, name or trademark for use on an instrument bearing the label name or trademark of a party other than ROCHE or its Affiliates; provided, however, that
nothing in this Section 6.6 shall be construed to limit the rights of ROCHE or its Affiliates to engage in activities with such third parties, to the extent such third parties have obtained
rights under the CHIRON Licensed Patents permitting such activities. 

        6.7    Limitation of Warranty.    EXCEPT AS SPECIFICALLY SET FORTH HEREIN, NO PARTY MAKES ANY REPRESENTATION OR
WARRANTY, EITHER EXPRESS OR IMPLIED, ARISING BY LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. 

11

 

 
 

ARTICLE 7
  TERM AND TERMINATION    
    

        7.1    Term.    (a) The parties acknowledge and agree that, effective as of the Effective Date (i) the
Original License Agreement shall be terminated, solely with respect to the application of its terms and conditions to the activities contemplated thereunder with respect to customers or potential
customers of ROCHE and ROCHE Affiliates which customers or potential customers are located within the Region; (ii) the terms and conditions of this Agreement shall replace and supercede the
Original License Agreement with respect to the activities contemplated thereunder and hereunder with respect to customers or potential customers of ROCHE and ROCHE Affiliates which customers or
potential customers are located within the Region; and (iii) notwithstanding the foregoing clauses (i) and (ii), the provisions of the Original License Agreement relating to the Region
shall survive the termination described in clause (i) above, solely with respect to the activities contemplated thereunder occurring prior to the Effective Date with respect to customers or
potential customers of ROCHE and ROCHE Affiliates which customers or potential customers are located within the Region. 

        (b)   Unless
earlier terminated pursuant to Sections 7.2 or 7.3 below, this Agreement shall be in effect from the Effective Date and shall terminate in each member country
within the Region seventeen (17) years from January 1, 2001, or on the expiration of the last to expire of the patents within the CHIRON Licensed Patents based upon a patent existing or
a patent application pending as of the Effective Date, whichever is later (the "Term"); provided, however, that prior to the termination of this Agreement in the first member country in which it would
otherwise terminate pursuant to the foregoing, ROCHE may, in its discretion, elect by written notice to CHIRON to extend this Agreement as to all such member countries for an additional term which
shall expire on a country-by-country basis on the expiration date of the last to expire patent within the CHIRON Licensed Patents existing in such member country as of the date
of such extension. 

        7.2    Voluntary Termination.    ROCHE may voluntarily terminate all, but not less than all, licenses granted to ROCHE
and its Affiliates under this Agreement and the Original License Agreement on a country-by-country basis within the Region, on not less than six (6) months prior written
notice to CHIRON. 

        7.3    Termination by CHIRON.    CHIRON may terminate this Agreement and the Original License Agreement only upon any
of the following grounds: 

        (a)   ROCHE's
or its Affiliate's material breach of this Agreement or the Original License Agreement, including, without limitation, a breach resulting from ROCHE's or its
Affiliate's failure to pay any sums due hereunder or thereunder, where such breach shall not have been remedied within thirty (30) days of the receipt of a written notification from CHIRON
identifying the breach and requiring its remedy; whereupon termination under this Section 7.3(a) shall be effective upon the expiration of such thirty (30) day cure period, subject to
Section 7.6; or 

        (b)   [***].
 [***]

        7.4    Enforcement After Termination.    Upon valid termination of this Agreement under Section 7.2 or 7.3,
ROCHE and its Affiliates shall have no further rights under CHIRON Licensed Patents and CHIRON shall not be limited to its remedies under this Agreement, to the extent of such termination. 

        7.5    Accrued Rights.    Termination of this Agreement for whatever reason shall not affect any rights which have
accrued prior to termination, including without limitation royalty obligations occurring during the Term, calculated in accordance with Article 3 and Exhibit A. 

        7.6    ROCHE Challenge to Section 7.3(a) Termination.    In the event ROCHE provides written notification to
CHIRON prior to expiration of the thirty (30) day notice/cure period referenced in 

12

 

Section 7.3(a)
that ROCHE disputes whether the grounds for termination under Section 7.3(a) are present, such dispute shall be submitted to ADR pursuant to Article 10. The thirty
(30) day notice/cure period shall be suspended during the pendancy of such ADR, provided that during the pendancy of the ADR, ROCHE shall continue to make any disputed payments to CHIRON, on
the condition that CHIRON shall repay ROCHE the amounts of such disputed payments if ROCHE prevails in the ADR, plus interest at the rate described in Section 4.9. Notwithstanding anything in
this Section 7.6 to the contrary, ROCHE may submit a dispute concerning a method by which amounts payable by ROCHE and its Affiliates to CHIRON hereunder are calculated only one time, and any
resolution from the ADR shall bind the parties as to such calculation method thereafter. 

        7.7    ROCHE Challenge to Section 7.3(b) Termination.    In the event that ROCHE, within thirty
(30) days of receiving notice of termination by CHIRON for the grounds set forth in Section 7.3(b) above, provides written notice to CHIRON that ROCHE disputes whether such grounds are
present, such dispute shall be submitted to ADR pursuant to Article 10 and termination of this Agreement shall be suspended during the pendancy of the ADR, provided that ROCHE suspends its
action, suit or proceeding (other than in an ADR proceeding between the parties as permitted by Section 7.3 (b) and Article 10)  [***], and continues to perform all of its material
obligations hereunder. 

        7.8    Audit Results Not Grounds for Termination.    CHIRON's request for an audit under Section 4.6 shall not
be treated as a notice of breach under Section 7.3(a). In the event such audit determines there has been an underpayment by ROCHE, such underpayment shall not constitute grounds for termination
by CHIRON under Section 7.3(a) unless: (a) ROCHE has failed to rectify such underpayment in accordance with Section 4.6; (b) ROCHE has failed to rectify such underpayment
after notification and opportunity to cure under Section 7.3(a); and (c) any ADR requested by ROCHE, pursuant to Section 7.6, and directed to any dispute concerning such
underpayment, results in a determination favorable to CHIRON and ROCHE has failed to rectify such underpayment. Notwithstanding the foregoing, ROCHE shall continue to make the disputed payments to
CHIRON, on the condition that CHIRON shall repay ROCHE the amounts of such disputed payments with respect to which ROCHE prevails in the ADR, plus interest at the rate described in Section 4.9. 

        7.9    Survival.    The following provisions of this Agreement shall survive termination or expiration of this
Agreement, in accordance with their respective terms: Article 1; Sections 4.6, 4.7, 4.8, 4.9, 6.7, 7.4, 7.5 and 7.9; Articles 8, 9, and 10; Sections 11.9 through 11.14; Section 12.2(b);
and Section 14.1. 

 
 

ARTICLE 8
  CONFIDENTIALITY    
    

        8.1    Obligation.    From time to time during the Term, CHIRON and ROCHE may provide to each other information
concerning patents, patent applications, license agreements and other confidential or proprietary information related to this Agreement (the "Information"). Notwithstanding anything in this Agreement
to the contrary, following execution of this Agreement, Earned Royalty Amounts payable under this Agreement shall be deemed "Information" as to which both CHIRON and ROCHE shall be deemed to be the
party receiving the Information (the "Receiving Party"). Each Receiving Party shall during the Term and for a period of three (3) years after termination hereof: (a) maintain the
Information in confidence; (b) not disclose the Information to any third party, other than employees, agents or consultants of the Receiving Party, its Affiliates or permitted sublicensees who
have a need to know the Information and who are bound by confidentiality obligations to the Receiving Party no less restrictive than those contained herein; and (c) not use the Information for
any purpose not directly related to performance hereunder or otherwise authorized under this Agreement. 

        8.2    Exclusions.    The obligations of this Article 8 shall not apply to any Information which: (a) is
or which becomes generally known to the public by publication or by means other than a breach of a 

13

 

duty
by the Receiving Party; (b) is otherwise known by the Receiving Party at the time of disclosure by the other party; (c) otherwise becomes available to the Receiving Party from a
third party not in breach of confidentiality obligations to the other party; or (d) is developed by or for the Receiving Party independent of any disclosure from the other party. The Receiving
Party also shall be permitted to make disclosures of Information which are reasonably necessary in connection with a possible grant of a permitted sublicense by the Receiving Party or in due diligence
related to a possible acquisition, merger, consolidation substantial asset transfer or similar transaction of the Receiving Party, provided that the recipient is bound to the Receiving Party by
confidentiality obligations with respect to the Information no less restrictive than those contained herein. Nothing herein shall prevent the Receiving Party from making such disclosures of
Information as are reasonably required by law, regulation (including 37 C.F.R. § 1.56), or order of any court or governmental agency; provided that the Receiving Party has provided
reasonable advance notice to allow the disclosing party the opportunity to seek a protective order or otherwise contest, prevent or limit such disclosure. 

        8.3    Return of Information.    Upon termination of this Agreement for any reason, the Receiving Party shall return,
or at the option of the disclosing party, certify destruction of, all Information and copies thereof; provided that the Receiving Party may retain one copy thereof in its law department files solely
for evidentiary and regulatory purposes. 

        8.4    Disclosure of Agreements and Terms.    Each of the parties may issue a press release disclosing the existence
of this Agreement. Subject to mutual agreement as to form and substance, the parties may make selected disclosure of the material financial terms in such press releases. Each party may disclose any of
the terms of this Agreement to any Affiliate; provided that the recipient of such disclosure is obligated to confidentiality terms no less restrictive than those contained in this Article 8.
Each party may disclose any information contained in or regarding this Agreement to the extent required in its respective reasonable judgment by applicable law, regulation or order of any court or
governmental agency. Further, each party may determine in its respective discretion to file this Agreement under the Securities and Exchange Act of 1934 or otherwise with any United States or foreign
governmental agency, even if that filing may result in this Agreement becoming available to the public generally. The filing party shall seek confidential treatment for at least the essential
financial terms hereof in connection with any such filing, subject to applicable law and regulation, and shall notify the other party in advance of any such filing and consider such suggestions as the
other party may make as to the terms herein as to which the filing party should seek confidential treatment. 

 
 

ARTICLE 9
  INDEMNITY    
    

        9.1    ROCHE Indemnity.    ROCHE shall indemnify, defend and hold harmless CHIRON and its Affiliates and their
officers, directors, shareholders, employees, representatives and agents, against any claim, demand, loss, damage or injury, including reasonable attorneys' fees, asserted by a third party, arising
from, relating to, or otherwise in respect of, (a) the manufacture, use or sale of CHIRON Licensed Products within the Region, or (b) any breach by ROCHE or its Affiliates of any
representation, warranty or covenant under this Agreement; provided, however, that such indemnity shall not extend to damages arising directly from any breach or willful or negligent act of CHIRON or
its Affiliates. 

        9.2    CHIRON Indemnity.    CHIRON shall indemnify, defend and hold harmless ROCHE and its Affiliates and their
officers, directors, shareholders, employees, representatives and agents, against any claim, demand, loss, damage or injury, including reasonable attorneys' fees, asserted by a third party, arising
from, relating to, or otherwise in respect of, (a) the manufacture, use or sale of ROCHE Optioned Products within the Region, or (b) any breach by CHIRON or its Affiliates of any
representation, warranty or covenant under this Agreement; provided, however, that such indemnity shall not extend to damages arising directly from any breach or willful or negligent act of ROCHE or
its Affiliates. 

14

  

        9.3    Indemnification Procedures.    In the event either party claims indemnification pursuant to this
Article 9, the indemnified party shall promptly notify the indemnifying party in writing upon becoming aware of any claim to which such indemnification may apply. Delay in providing such notice
shall constitute a waiver of the indemnifying party's indemnity obligations hereunder only if the indemnifying party's ability to defend such claim is materially impaired thereby. The indemnifying
party shall have the right to assume and solely control the defense of the claim at its own expense. If the right to assume and solely control the defense is exercised, the indemnified party shall
have the right to participate in, but not to control, such defense at its own expense, and the indemnifying party's indemnity obligations shall be deemed not to include attorneys' fees and litigation
expenses incurred by the indemnified party after the assumption of the defense by the indemnifying party. If the indemnifying party does not assume the defense of the claim, the indemnified party may
defend the claim at the indemnifying party's expense. The indemnified party shall not settle or compromise the claim without the prior written consent of the indemnifying party, and the indemnifying
party shall not settle or compromise the claim in any manner which would have an adverse effect on the indemnified party without the consent of the indemnified party, which consent, in each case,
shall not be unreasonably withheld. The indemnified party shall reasonably cooperate with the indemnifying party and shall make available to the indemnifying party all pertinent information under the
control of the indemnified party, all at the expense of the indemnifying party. 

        9.4    Sunset.    The provisions of Sections 9.1 and 9.2 shall continue in effect on a
claim-by-claim basis, after the termination of this Agreement, only until the expiration of the last to expire statute of limitations applicable to such claim. 

        9.5    Limitation of Liability.    Neither party shall be liable to the other for any consequential, special, indirect
or exemplary damages or for the loss of profits arising from the performance or nonperformance of this Agreement or any acts or omissions associated herewith. 

 
 

ARTICLE 10
  ALTERNATIVE DISPUTE RESOLUTION    
    

        The parties recognize that bona-fide disputes may from time to time arise which relate to any aspect
of this Agreement, including, without limitation, any of the parties' rights and/or obligations hereunder, and including, without limitation, disputes relating to the interpretation, form, validity,
performance and/or termination of this Agreement or relating to infringement, scope, claims construction, or (without limiting the effect of Section 7.3(b)) validity or enforceability of the
CHIRON Licensed Patents. In the event of the occurrence of any dispute, a party may, by notice to the other party, have such dispute referred to their respective employees designated below or their
successors, for
attempted resolution by good faith negotiations within ninety (90) days after such notice is received. Said designated officers are as follows: 

For
ROCHE:
 President

Roche Molecular Systems, Inc.
  

For CHIRON:
 President

Blood Testing  

        In the event the designated officers after such good faith negotiations, are not able to resolve such dispute within such ninety (90) day period, or any
agreed extension thereof, a party may invoke the provisions for binding ADR as set forth in Paragraph 9 of the Settlement Agreement. Neither party shall seek recourse against the other
hereunder in any court or other forum, except as permitted by Paragraph 9 of the Settlement Agreement or as may be necessary to enforce a determination made in ADR pursuant to this
Article 10 and Paragraph 9 of the Settlement Agreement. 

15

 
 
 

ARTICLE 11
  MISCELLANEOUS    
    

        11.1    Assignment.    

        (a)   ROCHE
and its Affiliates may not assign or transfer any rights under this Agreement without the prior written consent of CHIRON, except to a ROCHE Affiliate, and then
only for so long as the assignee remains a ROCHE Affiliate, or as part of the sale or transfer of all or substantially all of ROCHE's and all of its Affiliates' assets and businesses to which this
Agreement relates. In the case of a permitted assignment or transfer, the performance of the assignee shall be guaranteed by ROCHE. 

        (b)   CHIRON
and its Affiliates may not assign or transfer any rights under this Agreement without the prior written consent of ROCHE, except to a CHIRON Affiliate, and then
only for so long as the assignee remains a CHIRON Affiliate, or as part of the sale or transfer of all or substantially all of CHIRON's and all of its Affiliates' assets and businesses to which this
Agreement relates. In the case of a permitted assignment or transfer, the performance of the assignee shall be guaranteed by CHIRON. 

        11.2    Force Majeure.    A party hereto shall not be liable for, nor shall this Agreement be terminable or cancelable
by reason of, any delay or default in any such party's performance hereunder, to the extent that such default or delay is caused by events beyond such party's reasonable control including, but not
limited to: acts of God; regulation, law or action of any government or agency thereof; war or insurrection; civil commotion; labor disturbances; epidemic; or failure of suppliers, public utilities or
common carriers. Each party shall give prompt notice to the other party of such cause, and shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as
possible. 

        11.3    Severability.    In the event that any one or more of the provisions of this Agreement should for any reason
be held by any court or authority having jurisdiction over this Agreement or over the parties hereto to be invalid, illegal or unenforceable, such provision or provisions shall be reformed to
approximate as nearly as possible the intent of the parties, in such jurisdiction; elsewhere, this Agreement shall not be affected. 

        11.4    Entire Agreement; Termination of Original License Agreement.    This Agreement together with the Exhibits,
Attachments and Schedules and [***], constitute the entire agreement among the parties relating to the subject matter of this
Agreement. Upon execution and delivery of this Agreement, the parties acknowledge and agree that this Agreement shall supercede all prior written and oral agreements with respect to the subject matter
hereof, including specifically the Original License Agreement, which is hereby terminated and superceded by this Agreement solely with respect to its application to the Region, as more fully described
in Section 7.1(a) above. There are no other understandings, representations or warranties of any kind. 

        11.5    Amendment.    This Agreement shall not be altered, extended or modified except by written agreement of the
parties. 

        11.6    Waiver.    Failure by a party hereunder to enforce any right under this Agreement shall not be construed as a
waiver of such right or any other rights under this Agreement; nor shall a waiver by a party hereunder in one or more instances be construed as constituting a continuing waiver or as a waiver in other
instances. 

        11.7    Costs.    Each of the parties hereto shall be responsible for its respective legal and other costs incurred in
relation to the preparation of this Agreement. 

        11.8    Counterparts.    This Agreement may be executed in two (2) or more counterparts, each of which shall be
deemed to be an original, but all of which, taken together, shall constitute one and the 

16

 

same
instrument. Facsimile copies of signatures for a party shall be deemed to be originals for purposes of execution of the Agreement. 

        11.9    Notices.    

        (a)   Any
notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if personally delivered or sent by first
class mail, or express or air mail or other postal service, or by certified mail, return receipt requested. 

        (b)   Any
notice required by this Agreement shall be forwarded to the respective addresses and marked for the attention of the persons set forth below unless such addresses
subsequently change by written notice to the other party: 

	ROCHE:	 	F. Hoffmann-La Roche Ltd.

Grenzacherstrasse 124

Basel

Bale 4002

Switzerland

Attn: Head of Diagnostics Division
	

Copy to:	
 	

General Counsel

Roche Molecular Systems, Inc.

1145 Atlantic Avenue

Alameda, CA 94501
	
CHIRON:	
 	

Chiron Corporation

4560 Horton Street

Emeryville, California 94608

Attn.: President, Blood Testing
	

Copy to:	
 	

General Counsel

Chiron Corporation

4560 Horton Street

Emeryville, CA 94608

        (c)   Any
such notice or other document shall be deemed to have been effective when received by the addressee. To prove the giving of a notice or other document it shall be
sufficient to show that it was received. 

        11.10    Governing Law.    All matters affecting the interpretation, form, validity, performance and termination of
this Agreement shall be decided and interpreted under the laws of the State of New York, excluding any choice of law rules which may direct application of the laws of any other jurisdiction. 

        11.11    Relationship of the Parties.    The relationship of the parties under this Agreement is that of independent
contractors. Nothing contained in this Agreement is intended or is to be construed so as to constitute the parties as partners, joint venturers or agents of the other. Neither party or its Affiliates
has any express or implied right or authority under this Agreement to assume or create any obligations or make any representations or warranties on behalf of or in the name of the other party or its
Affiliates. 

        11.12    Headings.    The headings of the Articles and Sections in this Agreement have been inserted for convenience
only and do not constitute part of this Agreement. 

        11.13    No Trademark Rights.    No right, express or implied, is granted by this Agreement to either party to use in
any manner the name, trade name or trademark of the other party in connection with the performance of this Agreement. 

17

 

        11.14    No Implied Licenses.    No license, express or implied, is granted by this Agreement to either party, other
than the licenses or options granted under Sections 2.1, 2.3, 2.4 and 2.5. 

 
 

ARTICLE 12
  FIELD RESTRICTIONS AND OTHER COVENANTS    
    

        12.1    ROCHE Covenant Regarding In Vitro Diagnostics    

        (a)   ROCHE
and its Affiliates shall not label or promote any CHIRON Licensed Product labeled or promoted for use in the Field in any respect for use outside of the Field
(namely, in In Vitro Diagnostics) within the Region; and ROCHE shall use commercially reasonable efforts to prevent its Authorized Distributors from
labeling or promoting any CHIRON Licensed Products labeled or promoted for use in the Field in any respect for use outside the Field (namely in In Vitro
Diagnostics) within the Region. 

        (b)   Further,
ROCHE and its Affiliates and Authorized Distributors shall include on or with each CHIRON Licensed Product labeled or promoted for use in the Field within the
Region a statement to the effect that the CHIRON Licensed Product is not intended for use in In Vitro Diagnostics, using language to be determined by
ROCHE and approved in advance in writing by CHIRON, which approval shall not be unreasonably withheld. The location of such notice shall be the product insert of such CHIRON Licensed Products or such
other reasonably prominent location to be determined by ROCHE. 

        (c)   In
the event that ROCHE or CHIRON becomes aware of any material use in In Vitro Diagnostics of CHIRON Licensed Products
labeled or promoted for use in the Field within the Region, such party will promptly notify the other in writing of the relevant facts and, if so requested by CHIRON, ROCHE will meet and confer with
CHIRON in good faith to determine what steps either or both should take to abate such infringing use. 

        (d)   Nothing
in this Section 12.1 shall prohibit ROCHE from offering for sale or selling to End Users Products configured for use primarily in  In Vitro Diagnostics to satisfy the bona
fide requirements of such End Users for use in  In Vitro Diagnostics and any Blood Screening use by such End Users of any such Products configured for use primarily in
In
Vitro Diagnostics shall not be deemed a breach of this Section 12.1. 

        (e)   Nothing
in this Section 12.1 shall apply to any product or activity of ROCHE or its Affiliates to the extent that such product or activity is a necessary or
customary activity in connection with a Registration pursuant to Section 5.3. 

        12.2    Passive Sales.    

        (a)   Notwithstanding
anything to the contrary in this Agreement and specifically the foregoing provisions of Section 12.1, nothing in this Agreement is intended to
prohibit Passive Sales of the CHIRON Licensed Product by ROCHE, its Affiliates or its Authorized Distributors or Cross Sellers (subject to Section 12) within the Region. Passive Sales will be
subject to the Blood Screening royalty provisions set forth in Article 3 and Exhibit A, without application of any adjustment to Earned Royalties for Home Brew Screening pursuant to
Paragraph 2 of Exhibit A. 

        (b)   Without
limiting the labeling and promoting obligations under Section 12.1, CHIRON shall not sue ROCHE, its Affiliates, its Authorized Distributors or its End
User customers (including, but not limited to, Cross Sellers) for any Passive Sale, or for the use by In Vitro Diagnostics End Users of a CHIRON
Licensed Product outside of the Field within the Region, whether arising during the Term, or during the term of the Original License Agreement prior to the Effective Date (it being understood that
nothing herein constitutes an admission by ROCHE 

18

 

or
any of its Affiliates with respect to any such actual or alleged sales or use under the Original License Agreement). 

        12.3    Cross Sales.    

        (a)   Notwithstanding
anything to the contrary in this Agreement and subject to the provisions of this Section 12.3, nothing in this Agreement is intended to prohibit
an End User from selling CHIRON Licensed Product purchased from ROCHE, its Affiliates or an Authorized Distributor to another person or entity  [***] within the Region ("Cross Sales"). 

        (b)   Notwithstanding
the provisions of Section 12.1 of this Agreement or anything in this Agreement to the contrary, if at any time during the Term CHIRON forms a
reasonable belief that significant Cross Sales are occurring within the Region, it will promptly inform ROCHE in writing of the existence and basis of such belief.  [***]. 

        12.4    Patent Marking.    ROCHE and its Affiliates shall include a patent notice on each CHIRON Licensed Product to
identify the CHIRON Licensed Patents which such CHIRON Licensed Product, but for the licenses granted herein, would infringe one or more Valid Claims (or for which royalties are being paid); provided,
however, identification of CHIRON Licensed Patents on a CHIRON Licensed Product shall in no way be deemed to be an admission by ROCHE or its Affiliates, or raise a presumption, that such CHIRON
Licensed Product is in fact covered by such CHIRON Licensed Patent. 

        12.5 The
understanding and intent of the parties is that the amendments made by this Agreement reflect the unique circumstances applicable to ROCHE arising from the fact
that ROCHE is a licensee under both this Agreement and the HCV Diagnostics Agreements, and that, taking such unique circumstances into account, this Agreement imposes new burdens on ROCHE rather than
granting new benefits to ROCHE. [***]. 

 
 

ARTICLE 13
  INFRINGEMENT BY THIRD PARTIES    
    

        13.1    Notice of Infringement.    Each party shall notify the other if it becomes aware of Infringing Third Party
Sales. CHIRON shall have the exclusive right to take action against any infringement of any of the CHIRON Licensed Patents, in its sole discretion, subject to this Article 13. 

        13.2    Infringement Litigation.    

        (a)   In
the event that "substantial" Infringing Third Party Sales are occurring in a country within the Region in which ROCHE or its Affiliates or an Authorized Distributor
is selling a CHIRON Licensed Product (in each such country, the "Impacted Product"), and ROCHE has notified CHIRON pursuant to Section 13.1 of the existence of such infringement in  [***] (an
"Infringement Notice"), then the provisions of this Section 13.2 shall apply. For purposes of this
Section 13.2, "Major Country" shall mean [***]. 

        (b)   For
purposes of this Section 13.2, an Infringing Third Party Sale shall be considered substantial in a country if the infringing third party achieves market
share, in the case of Blood Screening of [***], and in the case of Plasma Fractionation of  [***] of the Aggregated Products in such country [***].
For purposes of this Section 13.2, "Aggregated Products" means the number of Units of CHIRON Licensed Products of the applicable Field Category plus the number of Competitive Products sold (or
used, in the case of Plasma Fractionation) in a country, and "Competitive Products" means the number of Units of Products which are sold (or used, in the case of Plasma Fractionation) of the
applicable Field Category and which compete with a CHIRON Licensed Product sold or used by ROCHE or its Affiliates in a country. 

19

 

        (c)   If
the Infringement Notice identifies an Impacted Product in a Major Country and CHIRON fails to institute legal action in a Major Country or other country acceptable to
ROCHE [***] following receipt by CHIRON of the Infringement Notice and infringement is not otherwise abated, then ROCHE shall be
relieved of the obligation to pay the portion of Earned Royalties set forth in Section 13.2(d) with respect to the Impacted Product until such time as CHIRON institutes such legal action as
described in this Section 13.2(c); provided, however, that CHIRON need not initiate or continue any such legal action, if, after reasonably diligent effort (including reasonably diligent effort
by ROCHE if requested by CHIRON), CHIRON is unable to acquire admissible evidence sufficient to establish a prima facia case of infringement under the law of the applicable country; and provided
further, that CHIRON shall not be obligated to institute or maintain more than three such actions at any time with regard to Impacted Products in Plasma Fractionation. 

        (d)   If
CHIRON has not instituted such legal action at the end of such [***], to the extent required
under Section 13.2(c), and such infringement is not otherwise abated, the Earned Royalty with respect to an Impacted Product in Blood Screening shall be reduced by  [***] from the amount otherwise
payable under Paragraph 1 of Exhibit A (excluding the effect of any reduction in
Earned Royalty Amounts triggered by operation of Paragraph 2 of Exhibit A) and with respect to an Impacted Product in Plasma Fractionation shall be reduced by  [***]. If, at the end of
[***] thereafter, CHIRON has
not instituted such legal action, to the extent so required, and infringement is not otherwise abated, Earned Royalties on such Impacted Product shall be reduced by an  [***] of the original Earned
Royalties, such that if legal action required under Section 13.2(c) has not commenced and
the infringement is not otherwise abated by, in the case of an Impacted Product in Blood Screening the end of the [***]following
receipt by CHIRON of the Infringement Notice and in the case of an Impacted Product in Plasma Fractionation the end of the [***]
following receipt by CHIRON of the Infringement Notice, [***] shall be payable hereunder with respect to the Impacted Product. 

        (e)   The
obligations to pay Earned Royalties shall be reinstated on a prospective basis at such time as ROCHE receives written notice of the institution of legal action in
accordance with Section 13.2(c) or the infringement is otherwise abated, all subject to Section 13.2(f). 

        (f)    If
legal action required under Section 13.2(c) has not been instituted and the infringement is not otherwise abated in the case of an Impacted Product in Blood
Screening for more than [***] following receipt by CHIRON of the Infringement Notice and in the case of an Impacted Product in
Plasma Fractionation for more than [***] following receipt by CHIRON of the Infringement Notice, and if, as a result of the
infringement, sales of the Impacted Product [***] by ROCHE, its Affiliates or an Authorized Distributor have declined by  [***] or more during the preceding
[***] then upon
reinstatement of Earned Royalties pursuant to Section 13.2(e), the parties shall meet and confer regarding possible adjustments to the Earned Royalties for the Impacted Product in view of such
degradation of the market. The parties will discuss possible rate reductions, as well as a plan for reinstating the original economic expectations of the parties. It is expected that any agreement for
reduction of Earned Royalties will be phased out over time, so as to return to the Earned Royalties set
forth in Exhibit A. If the parties fail to reach agreement on any such adjustment, the matter shall be submitted for resolution by ADR, except that in the event of ADR, each party shall submit
to the neutral a proposal with respect to adjustments pursuant to this Section 13.2(f). The neutral shall be empowered to choose one proposal or the other, but shall not be empowered to order
any such adjustment other than as proposed by one of the parties. 

        13.3    Cooperation.    ROCHE and its Affiliates shall cooperate with CHIRON in connection with any legal action
referred to in this Article 13. 

20

 
 
 

ARTICLE 14
  OTHER EUROPEAN COMMUNITY PROVISIONS    
    

        14.1    Competition Notification.    If either party (the "Notifying Party") elects to file a notification with
respect to this Agreement (a "Notification") with the Competition Directorate of Commission of European Community (the "Commission") in accordance with regulations established by the Commission, the
Notifying Party shall provide a non-confidential version of the final draft to the other party for comment at least thirty (30) days before making the filing and shall consider in
good faith the modification thereto, if any, that the other party may propose. The other party shall execute all documents reasonably required by the Notifying Party and shall otherwise reasonably
cooperate in connection with the Notification. The Notifying Party shall bear all costs incurred by it relating to the Notification. 

        14.2    Reformation.    If, at any time during the Term, either party receives a request or other communication from
the Commission with respect to the Notification (a "Request"), such party shall promptly inform the other of the nature of the Request. In the event that the Commission indicates in a Statement of
Objection(s) that this Agreement will violate the provisions of Article 81 or 82 of the Treaty of Rome, then the parties shall amend this Agreement by making those minimal modifications
necessary to satisfy the concerns of the Commission as set forth in the Statement of Objection(s). Notwithstanding the foregoing, the parties agree that ROCHE shall retain substantially the same
license rights at substantially the same royalties as specified under this Agreement. 

        IN
WITNESS WHEREOF this Agreement has been executed by duly authorized officers of CHIRON and ROCHE as of the Effective Date. 

	CHIRON CORPORATION
	

By:	
 	

/s/  WILLIAM G. GREEN      
	
 	

 
	

Title:	
 	

SVP, General Counsel & Secretary	
 	

 
	

Date:	
 	

July 10, 2003
	
 	

 
	
F. HOFFMANN-LA ROCHE LTD.
	

By:	
 	

/s/  HEINO VON PRONDZYNSKI      
	
 	

 
	

Title:	
 	

Head of Diagnostics	
 	

 
	

Date:	
 	

July 29, 2003
	
 	

 
	

By:	
 	

 	
 	

 
	 	 	
	 	 
	

Title:	
 	

 	
 	

 
	

Date:	
 	

 	
 	

 
	 	 	
	 	 
	ROCHE MOLECULAR SYSTEMS, INC.
	

By:	
 	

/s/  H. DREISMANN      
	
 	

 
	

Title:	
 	

President	
 	

 
	

Date:	
 	

July 18, 2003
	
 	

 

21

 
 

Exhibit A
  
    Compensation to Chiron Corporation    
    

        1.    Earned Royalty.    Subject to the adjustments referenced in this Exhibit A, royalties paid to CHIRON
under this Agreement in any Calendar Quarter (the "Earned Royalty") shall be calculated as follows: 

        The
Earned Royalty for each Calendar Quarter shall be the [***]

	Field Category:
 
	 	Earned Royalty Amounts

	[***]	 	[***]
	[***]	 	[***]

        (a)   Notwithstanding
the above, [***]

        (b)   [***], the parties shall meet and reasonably consider adjustment to the Earned Royalty Amount
with respect to each CHIRON Licensed Product [***]. Any such adjustment should reflect both  [***]. Accordingly, an increase in Earned Royalty Amounts may
be justified by an increase  [***]. Generally, the parties intend that Earned Royalty Amounts should be not less than  [***]. No adjustment shall be made to
any Earned Royalty Amount unless mutually agreed;
[***]. 

        (c)   Earned
Royalties shall be payable quarterly, commencing with the Calendar Quarter ending [***],
within seventy-five (75) days following the end of each Calendar Quarter. Such payment shall be made in accordance with the payment and reporting obligations set forth in
Article 4 and is fully earned when paid and is non-refundable. 

        (d)   [***], the parties shall meet and reasonably consider adjustment to the allocation of
jurisdictions to the extent located within the Region. Generally, the parties intend that [***]. No adjustment shall be made to
the allocation of jurisdictions within the Region unless mutually agreed. 

        2.    Home Brew Adjustment.    With respect to sales of CHIRON Licensed Products in  [***] for use in Blood Screening, the
[***] as set forth
in this Paragraph 2, [***], if in the [***]

	[***]

[***]
	 	Reduced

Earned Royalty Amount

	(in units)

greater than [***]	 	[***]
	greater than [***]	 	[***]

If
the parties are unable otherwise to agree within thirty (30) days of a request by either party, [***]. In the event
that Home Brew Screening achieve a market share [***] in Blood Screening  [***], the parties shall meet and confer, at ROCHE's request, to consider
reasonably and in good faith the actions that CHIRON
might take to abate such Home Brew Screening. [***]. As used herein, "Home Brew Screening" shall mean the use in Blood Screening
of probe screening methods Directed to HCV not licensed by CHIRON and not utilizing any assay, kit, reagent or other component Directed to HCV made by or for ROCHE or any other CHIRON licensee in the
Field. ROCHE may have the benefit of the adjustment to Earned Royalty Amounts provided by this Paragraph 2 or the adjustment to Earned Royalty Amounts provided under Section 13.2, at its
election, but not both. 

        3.    Pre-Licensing Royalties.    Notwithstanding anything to the contrary in the Agreement or this
Exhibit A, Earned Royalties shall be paid on Units for investigational or other pre-licensure use. 

        4.    Most Favored Licensee.    CHIRON shall promptly notify ROCHE if it grants to a third party a license under
CHIRON Licensed Patents to (i) practice in Blood Screening or Plasma Fractionation under terms that impose [***], or
(ii) [***] With such notification, CHIRON shall provide ROCHE with a summary of  [***]. At ROCHE's election, to be made in writing [***]
hereunder, or the [***]as applicable, shall be adjusted  [***]. Any such adjustment will be subject to the same terms as are 

 

applicable
to such minimum amounts payable by such third party, including, without limitation, [***]. This Paragraph 4
only applies to licenses that enable a third party to sell or use Products Directed to HCV for Blood Screening; provided, however, it does not apply to licenses of Products Directed to HCV for Blood
Screening that do not compete with Products then being sold by ROCHE. It also does not apply to a license that amends, replaces or supplements CHIRON's arrangement with  [***]. 

        5.    Single Royalty Per CHIRON Licensed Product.    Only one payment of Earned Royalty shall be due with respect to
any Net Sales or only one payment of Earned Royalty Amount shall be due with respect to any Unit of CHIRON Licensed Product Shipped, irrespective of the number of patents or Valid Claims in the CHIRON
Licensed Patents covering such CHIRON Licensed Product. 

        6.    Dispute Resolution.    Except as set forth in Paragraph 2 of this Exhibit A, any dispute between
CHIRON and ROCHE regarding whether any adjustment to or credits against Earned Royalties under this Exhibit A is appropriate, and which the parties fail to resolve themselves may only be
resolved by resort to the ADR provisions of Article 10. Until such dispute is resolved, ROCHE shall pay CHIRON the Earned Royalty provided for herein without benefit of the applicable disputed
adjustment on the condition that CHIRON shall repay ROCHE the amounts of such disputed payments if ROCHE prevails In the ADR, plus interest at the rate described in Section 4.9. 

2

 
 

EXHIBIT B—HCV
  Page 1 of 3
  
    Chiron HCV Patents
  
    [***]    
    

        [***]

        [***]

        [***]

        [***]

        [***]

 
 

EXHIBIT B—HCV
  Page 2 of 3
  
    [***]    
    

        [***]

        [***]

        [***]

        [***]

        [***]

 
 

EXHIBIT B—HCV
  Page 3 of 3    
    

        [***]

        [***]

        [***]

        [***]

        [***]

        [***]

 
 

EXHIBIT C—HCV
  Page 1 of 1
  
    [***]    
    

        [***]

        [***]

        [***]

 
 

Exhibit D    
    

Product Codes, BS kits:  

	Description
	 	SAP/Part No.

	[***]	 	[***]
	

[***]	
 	

[***]

 
 

EXHIBIT E
  
    Form of Report
  
    [To Be Attached]    

 
 

Existing Licenses or Rights granted in the Field under the Licensed Patents as of the Effective Date    
    

	1.
	Agreement
between Gen-Probe Incorporated and Chiron Corporation dated as of June 11, 1998 (the "Gen-Probe Agreement"). 

        [***]. 

        [***]. 

        [***]. 

        [***]. 

QuickLinks

Exhibit 10.321

[***]  CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

BLOOD SCREENING HCV PROBE LICENSE AGREEMENT— EUROPEAN UNION between CHIRON CORPORATION F. HOFFMANN-LA ROCHE LTD. and ROCHE MOLECULAR SYSTEMS, INC.

BLOOD SCREENING HCV PROBE LICENSE AGREEMENT —EUROPEAN UNION TABLE OF CONTENTS

BLOOD SCREENING HCV PROBE LICENSE AGREEMENT—EUROPEAN UNION

BACKGROUND

ARTICLE 1 DEFINITIONS

ARTICLE 2 LICENSE AND OPTION GRANTS

ARTICLE 3 PAYMENTS, ROYALTIES

ARTICLE 4 RECORDS AND REPORTS

ARTICLE 5 OTHER ACTIONS

ARTICLE 6 REPRESENTATIONS AND WARRANTIES

ARTICLE 7 TERM AND TERMINATION

ARTICLE 8 CONFIDENTIALITY

ARTICLE 9 INDEMNITY

ARTICLE 10 ALTERNATIVE DISPUTE RESOLUTION

ARTICLE 11 MISCELLANEOUS

ARTICLE 12 FIELD RESTRICTIONS AND OTHER COVENANTS

ARTICLE 13 INFRINGEMENT BY THIRD PARTIES

ARTICLE 14 OTHER EUROPEAN COMMUNITY PROVISIONS

Exhibit A Compensation to Chiron Corporation

EXHIBIT B—HCV Page 1 of 3 Chiron HCV Patents [***]

EXHIBIT B—HCV Page 2 of 3 [***]

EXHIBIT B—HCV Page 3 of 3

EXHIBIT C—HCV Page 1 of 1 [***]

Exhibit D

EXHIBIT E Form of Report [To Be Attached]

Existing Licenses or Rights granted in the Field under the Licensed Patents as of the Effective Date

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00054-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00054-of-00352.parquet"}]]