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EXHIBIT 10.40    
  

July 8,
2002 

DeWayne
Youngberg

4235 W. 105th Place

Westminster, CO 80031 

Re: Change of Control Agreement  

Dear
DeWayne 

        As
we have discussed, HealtheTech, Inc.(the "Company") has agreed to extend certain benefits to you in the event your employment with the Company is terminated within
eighteen months of a "Change of Control" of the Company. This letter sets out the terms of our agreement (the "Letter"). Capitalized terms are defined on Exhibit A, attached. 

        1.    Severance Benefits. If you or the Company terminates your employment at any time within the Change of Control Period, then
you will be entitled to receive severance benefits as follows: 

        (a)  Voluntary Resignation; Termination for Cause. If you terminate your employment by reason of voluntary resignation (and
not by Involuntary Termination) or if you are terminated for Cause, then you will not be entitled to receive severance or other benefits. 

        (b)  Involuntary Termination. If your employment is terminated or you terminate your employment as a result of Involuntary
Termination, you will be entitled to receive the following benefits: 

        (i)    severance
pay, based upon your base compensation as of the date your employment ceases, in an amount equal to one year of base compensation plus bonus (currently 40% of
base compensation) at target. Any amount payable shall be based on the regular compensation rate during the Severance Period, according to normal Company payroll practices and commencing with the
month immediately after the month in which your employment so ceases; 

        (ii)  coverage
under the Company's health, life, dental and other insurance programs for the Severance Period; and 

        (iii)  immediate
vesting of all stock options and shares of restricted stock held by you, including those granted or purchased after the date of this Letter. 

        (c)  Disability; Death. If the Company terminates your employment as a result of your Disability (as defined below) or such
employment is terminated by your death, then such termination shall be treated as if it were an Involuntary Termination, and the severance and other benefits shall be provided, in accordance with
subsection (b) above. 

        2.    Successors. Any successor to the Company (whether direct or indirect and whether by purchase, lease, merger,
consolidation, liquidation or otherwise) to all or substantially all of the Company's business and/or assets shall assume the obligations under this Letter and agree expressly to perform the
obligations under this Letter in the same manner and to the same extent as the Company would be required to perform such obligations in the absence of a succession. For all purposes under this Letter,
the term "Company" shall include any successor to the Company's business and/or assets which executes and delivers the assumption agreement described in this Section 3 or which becomes bound by
the terms of this Letter by operation of law. 

        3.    Law Governing; Arbitration. This Letter shall be governed by and construed in accordance with the laws of the State of
Colorado. Any dispute or controversy arising under or in connection with this Letter shall be settled exclusively in arbitration conducted in Colorado in accordance with the rules of the American
Arbitration Association then in effect. Judgment may be entered on the arbitrator's 

award in any court having jurisdiction. Punitive damages shall not be awarded. In any arbitration proceeding, the party determined to be the prevailing party shall be entitled to receive, in addition
to any other award, its attorneys' fees and expenses of the proceeding. 

        4.    Employment and Income Taxes. All payments made pursuant to this Letter will be subject to withholding of employment taxes. 

        By
your signature below, you indicate that you agree to the terms set out in this Letter. 

	 Very truly yours,	 	 
	

HEALTHETECH, INC.	
 	

 
	

/s/ Noel L. Johnson
 Name: Noel L. Johnson

Title: President & Chief Operating Officer	
 	

 
	

ACKNOWLEDGED AND AGREED:	
 	

 
	

/s/ DeWayne Youngberg
	
 	

 
	

Date:	
 	

July 8, 2002
	
 	

 

EXHIBIT A  

        Definition of Terms. The following terms referred to in this Letter shall have the following meanings: 

        "Cause" means (i) any act of personal dishonesty taken by you in connection with your responsibilities as an employee and intended
to result in substantial personal enrichment; (ii) your being convicted of a felony; or (iii) a willful act by you which constitutes gross misconduct and which is injurious to the
Company. 

        "Change of Control" means the occurrence of any of the following events: 

        (a)  Any
"person" (as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended), excluding existing beneficial
owners as of the date of this Letter, is or becomes the "beneficial owner" (as defined in Section 13d-3 of said Act), directly or indirectly, of securities of the Company
representing 50% or more of the total voting power represented by the Company's then outstanding voting securities, excluding conversion of any convertible securities issued as of the date of this
Letter; 

        (b)  The
composition of the Board of Directors changes during any period of 36 months such that individuals who at the beginning of the period were members of the
Board of Directors (the "Continuing Directors") cease for any reason to constitute at least a majority thereof; unless at least 662/3% of the Continuing Directors has either
(i) approved the election of the new Directors, (ii) if the election of the new Directors is voted on by shareholders, recommended that the shareholders vote for approval, or
(iii) otherwise determined that such change in composition does not constitute a Change of Control, even if the Continuing Directors do not constitute a quorum of the whole Board (it being
understood that this requirement shall not be capable of satisfaction unless there is at least one Continuing Director); 

        (c)  The
shareholders of the Company approve a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in
the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving
entity) at least 50% of the total voting power represented by the voting securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, or the
shareholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or disposition by the Company of all or substantially all of the Company's assets; 

        (d)  Any
other provision of this subsection notwithstanding, the term Change of Control shall not include either of the following events undertaken at the election of
the Company: 

        (i)    Any
transaction, the sole purpose of which is to change the state of the Company's incorporation; or 

        (ii)  A
transaction, the result of which is to sell all or substantially all of the assets of the Company to another corporation (the "surviving corporation") provided that
the surviving corporation is owned directly or indirectly by the shareholders of the Company immediately following such transaction in substantially the same proportions as their ownership of the
Company's common stock immediately preceding such transaction. 

        "Change of Control Period" means the period beginning with the date that a Change of Control has occurred (as determined by the Board of
Directors of the Company) and ending eighteen months later. 

        "Disability"    means that you suffer from a physical or mental disability to an extent that renders it impracticable for you to
continue performing your duties hereunder. You shall be deemed to be so disabled if (i) a physician selected by the Company (and the Company will use its best efforts to coordinate such
determination by the physician with the Company's long term disability insurance carrier) advises the Company that your physical or mental condition will render you unable to perform your duties for a
period exceeding three consecutive months, or (ii) due to a physical or mental 

condition, you have not substantially performed your duties hereunder for a period of three consecutive months. 

        "Involuntary Termination"    means (i) without your consent, your assignment to any duties or the significant reduction
of your duties, either of which is inconsistent with your position or title with the Company and responsibilities in effect immediately prior to such assignment, or your removal from such position and
responsibility, or a reduction in your title; (ii) a greater than10% reduction by the Company in your base compensation as in effect immediately prior to such reduction; provided, however, that
such reduction shall not apply if substantially all executive officers of the Company agree to a similar reduction in base compensation; (iii) a requirement to work at a new location more
distant from your principal residence than is the Company's current location in Golden, Colorado, or in any new location further than 30 miles from your principal residence, or (iv) any
purported termination of you by the Company (other than a voluntary termination initiated by the Executive) which is not effected for Disability or for Cause. 

        "Severance Period" means the twelve-month period following your termination of employment. 

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EXHIBIT 10.40CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

Exhibit 10.14

 

HspE7
COLLABORATION AGREEMENT

AMONG

STRESSGEN
DEVELOPMENT CORPORATION AND

STRESSGEN BIOTECHNOLOGIES CORPORATION

AND

F.HOFFMANN-LA ROCHE LTD AND
HOFFMANN-LA ROCHE INC.

June 21,
2002

 

 

TABLE
OF CONTENTS

 

	
  ARTICLE 1

  	
  DEFINITIONS

  	
   

  
	
  ARTICLE 2

  	
  LICENSES

  	
   

  
	
  2.1

  	
  License Grant To
  Roche

  	
   

  
	
  2.2

  	
  Sublicensees

  	
   

  
	
  2.3

  	
  Transfer of
  Stressgen Know-How

  	
   

  
	
  2.4

  	
  Other HPV Fusion
  Proteins

  	
   

  
	
  ARTICLE 3

  	
  INITIAL AND DEVELOPMENT EVENT PAYMENTS

  	
   

  
	
  3.1

  	
  Technology
  Development Payment

  	
   

  
	
  3.2

  	
  Equity
  Investments in Stressgen

  	
   

  
	
  3.3

  	
  Development
  Event Payments

  	
   

  
	
  3.4

  	
  Commercial
  Success Payments

  	
   

  
	
  ARTICLE 4

  	
  PAYMENTS BASED ON SALES OF TARGET PRODUCTS

  	
   

  
	
  4.1

  	
  Payments to
  Stressgen Based upon Worldwide Net Sales

  	
   

  
	
  4.2

  	
  Termination of
  Sales Based Payments

  	
   

  
	
  4.3

  	
  Adjustments
  Related to No Valid Claims

  	
   

  
	
  4.4

  	
  Adjustments
  Related to Third Party Competition

  	
   

  
	
  4.5

  	
  Adjustments
  Related to Third Party Payments

  	
   

  
	
  4.6

  	
  Payments Under
  the MIT Agreement

  	
   

  
	
  4.7

  	
  Maximum
  Adjustments

  	
   

  
	
  4.8

  	
  Combination
  Products

  	
   

  
	
  ARTICLE 5

  	
  PAYMENT, REPORTING, AUDITING

  	
   

  
	
  5.1

  	
  Currency and
  Conversion

  	
   

  
	
  5.2

  	
  Sales-Based
  Payments

  	
   

  
	
  5.3

  	
  Taxes

  	
   

  
	
  5.4

  	
  Blocked
  Countries

  	
   

  
	
  5.5

  	
  Accounting

  	
   

  
	
  ARTICLE 6

  	
  COLLABORATION GOVERNANCE

  	
   

  
	
  6.1

  	
  Steering
  Committee

  	
   

  
	
  6.2

  	
  Joint
  Development Committee

  	
   

  
	
  6.3

  	
  Finance
  Subcommittee

  	
   

  

 

i

 

TABLE
OF CONTENTS

(continued)

 

	
  6.4

  	
  Manufacturing
  Transition Team

  	
   

  
	
  6.5

  	
  Meetings and
  Responsibilities of the Steering Committee

  	
   

  
	
  6.6

  	
  Meetings and
  Responsibilities of the JDC

  	
   

  
	
  6.7

  	
  Decisions

  	
   

  
	
  ARTICLE 7

  	
  DEVELOPMENT PLAN AND CONDUCT OF DEVELOPMENT
  ACTIVITIES

  	
   

  
	
  7.1

  	
  Development Plan

  	
   

  
	
  7.2

  	
  Goals of Development

  	
   

  
	
  7.3

  	
  Conduct and
  Funding of Development Activities

  	
   

  
	
  7.4

  	
  Standards of
  Conduct

  	
   

  
	
  7.5

  	
  Diligent
  Development

  	
   

  
	
  7.6

  	
  Development
  Limitations

  	
   

  
	
  7.7

  	
  Updating the
  Development Plan

  	
   

  
	
  ARTICLE 8

  	
  DEVELOPMENT — REGULATORY AND SAFETY

  	
   

  
	
  8.1

  	
  Assignment of
  INDs, Other Documentation to Roche

  	
   

  
	
  8.2

  	
  Responsibility
  for Regulatory Affairs

  	
   

  
	
  8.3

  	
  Drug Safety

  	
   

  
	
  8.4

  	
  Product
  Withdrawals

  	
   

  
	
  8.5

  	
  Mutual Covenants

  	
   

  
	
  ARTICLE 9

  	
  MANUFACTURE AND SUPPLY

  	
   

  
	
  9.1

  	
  [* * *];
  Transition to New Manufacturing Process

  	
   

  
	
  9.2

  	
  Clinical
  Supplies of Process B Target Product

  	
   

  
	
  9.3

  	
  Clinical
  Supplies of Process A Target Product for Use in RRP and the Other Stressgen
  Development Activities

  	
   

  
	
  9.4

  	
  Clinical
  Supplies of Process B Target Product for Use in RRP and the Other Stressgen
  Development Activities

  	
   

  
	
  9.5

  	
  Commercial
  Supply

  	
   

  
	
  9.6

  	
  Packaging

  	
   

  
	
  ARTICLE 10

  	
  COMMERCIALIZATION

  	
   

  
	
  10.1

  	
  Responsibilities
  of Roche

  	
   

  
	
  10.2

  	
  Diligent Efforts
  by Roche; Reporting

  	
   

  

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

ii

 

TABLE
OF CONTENTS

(continued)

 

	
  10.3

  	
  Co-Promotion by
  Stressgen

  	
   

  
	
  10.4

  	
  Roche
  Competitive Products

  	
   

  
	
  ARTICLE 11

  	
  TRADEMARKS

  	
   

  
	
  11.1

  	
  Trademarks

  	
   

  
	
  ARTICLE 12

  	
  OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT
  RIGHTS

  	
   

  
	
  12.1

  	
  Ownership of
  Intellectual Property

  	
   

  
	
  12.2

  	
  Patent
  Prosecution and Maintenance

  	
   

  
	
  12.3

  	
  Infringement

  	
   

  
	
  12.4

  	
  Patent Notices

  	
   

  
	
  ARTICLE 13

  	
  CONFIDENTIAL INFORMATION

  	
   

  
	
  13.1

  	
  Non-Disclosure
  and Non-Use

  	
   

  
	
  13.2

  	
  Exceptions

  	
   

  
	
  13.3

  	
  Authorized
  Disclosure

  	
   

  
	
  13.4

  	
  Survival

  	
   

  
	
  ARTICLE 14

  	
  PUBLICATION AND PRESS RELEASE

  	
   

  
	
  14.1

  	
  Publications

  	
   

  
	
  14.2

  	
  Press Release;
  Public Disclosure of Agreement

  	
   

  
	
  ARTICLE 15

  	
  REPRESENTATIONS, WARRANTIES AND COVENANTS

  	
   

  
	
  15.1

  	
  Mutual
  Representations and Warranties

  	
   

  
	
  15.2

  	
  Stressgen
  Representations and Warranties

  	
   

  
	
  15.3

  	
  Roche
  Representations and Warranties

  	
   

  
	
  15.4

  	
  Stressgen
  Covenants

  	
   

  
	
  15.5

  	
  No Other
  Representations or Warranties

  	
   

  
	
  ARTICLE 16

  	
  TERM AND TERMINATION

  	
   

  
	
  16.1

  	
  Conditions
  Subsequent

  	
   

  
	
  16.2

  	
  Term

  	
   

  
	
  16.3

  	
  Breach

  	
   

  
	
  16.4

  	
  Termination by
  Roche Without Cause

  	
   

  
	
  16.5

  	
  Consequences of
  Termination

  	
   

  

 

iii

 

TABLE
OF CONTENTS

(continued)

 

	
  16.6

  	
  Termination for
  Failure to Satisfy Conditions Subsequent

  	
   

  
	
  16.7

  	
  Accrued Rights;
  Surviving Rights and Obligations

  	
   

  
	
  ARTICLE 17

  	
  INDEMNIFICATION

  	
   

  
	
  17.1

  	
  Indemnification
  by Stressgen

  	
   

  
	
  17.2

  	
  Indemnification
  by Roche

  	
   

  
	
  17.3

  	
  Procedure

  	
   

  
	
  17.4

  	
  Insurance

  	
   

  
	
  ARTICLE 18

  	
  DISPUTE RESOLUTIONS AND GOVERNING LAW

  	
   

  
	
  18.1

  	
  Disputes

  	
   

  
	
  18.2

  	
  Arbitration

  	
   

  
	
  18.3

  	
  Governing Law

  	
   

  
	
  ARTICLE 19

  	
  MISCELLANEOUS

  	
   

  
	
  19.1

  	
  Agency

  	
   

  
	
  19.2

  	
  Entire Agreement

  	
   

  
	
  19.3

  	
  Amendment

  	
   

  
	
  19.4

  	
  Possible
  Restructuring of Transaction

  	
   

  
	
  19.5

  	
  Assignment

  	
   

  
	
  19.6

  	
  Notices

  	
   

  
	
  19.7

  	
  Force Majeure

  	
   

  
	
  19.8

  	
  Severability

  	
   

  
	
  19.9

  	
  No Right to Use
  Names

  	
   

  
	
  19.10

  	
  Bankruptcy

  	
   

  
	
  19.11

  	
  Interpretation

  	
   

  
	
  19.12

  	
  Counterparts

  	
   

  
	
  19.13

  	
  Waiver

  	
   

  

 

iv

 

HspE7
Collaboration
Agreement

This HspE7  Collaboration Agreement (“Agreement”)
is made as of June 21, 2002 (“Execution Date”) by and among, on the one
hand, Stressgen Development Corporation, a Barbados
corporation, with its principal office at Whitepark House, White Park Road,
P.O. Box 806E, Bridgetown, Barbados (“Stressgen”), and, for the limited purposes
set forth in Section 2.1, Stressgen Biotechnologies
Corporation, a corporation organized under the laws of Yukon
Territory, Canada, with its principal office at #350 — 4243 Glanford Avenue,
Victoria, BC Canada V8Z 4B9 (“SBC”), and, on the other hand, F.Hoffmann-La Roche Ltd, a Swiss corporation, with
its principal office at Grenzacherstrasse 124, CH-4070-Basel Switzerland and Hoffmann-La Roche Inc., a New Jersey corporation,
with its principal office at 340 Kingsland Street, Nutley, New Jersey 07110
(collectively, “Roche”).

Recitals

1.             Stressgen and SBC own or control
intellectual property rights related to, among other products, HspE7 (as
defined below).

2.             Roche has expertise in the development
and commercialization of pharmaceutical products.

3.             Roche and Stressgen wish to enter into a
collaborative arrangement pursuant to which the parties shall co-develop HspE7
for certain specified indications, share in the development costs associated
therewith, and commercialize HspE7 worldwide.

4.             The Parties have prepared this Agreement
to govern their collaborative development and commercialization of HspE7.

5.             Simultaneously
with the execution of this Agreement, SBC and Roche shall execute that certain
Equity Agreement between Roche Finance Ltd and SBC (“Equity Agreement”),

 

 

Agreement

Now, Therefore, in consideration of the premises and the
mutual covenants and agreements contained in this Agreement, and in the Equity
Agreement, the Parties, intending to be legally bound, do hereby agree as
follows:

ARTICLE
1

DEFINITIONS

The following capitalized
terms, whether used in the singular or the plural, shall have the following
meanings as used in this Agreement unless otherwise specifically indicated:

1.1          “Affiliate” shall mean (a) an entity which owns,
directly or indirectly, a controlling interest in a Party, by stock ownership
or otherwise, (b) any entity which a Party owns a controlling interest, by
stock ownership or otherwise; or (c) any entity, under direct or indirect
common control of a Party.  For purposes
of this paragraph, “controlling interest” and “control” mean ownership of fifty
percent (50%) or more of the voting stock permitted to vote for the election of
the board of directors or any other arrangement resulting in control or the
right to control the management and the affairs of the Party. For purposes of
this Agreement, Genentech, Inc., 1 DNA Way, South San Francisco, California,
shall not be deemed an Affiliate of Roche.

In addition, Roche is presently seeking permission to acquire an
interest in Chugai Pharmaceutical Company Ltd. (“Chugai”).  Nothing in this Agreement is to be construed
as binding Chugai to any of the terms and conditions contained in this
Agreement.  However, should Chugai
become a Roche Affiliate it shall be bound by the terms and conditions of this
Agreement and shall have all rights and obligations of an Affiliate under this
Agreement.  If Chugai should become a
Roche Affiliate but not agree to be bound by the terms and conditions of this
Agreement, then Chugai shall have none of the rights and obligations of an
Affiliate of Roche under this Agreement, and Roche shall not grant a sublicense
to Chugai under this Agreement without prior written consent of Stressgen.

 

2

 

1.2          “BLA Filing” shall mean a Biologics Licensing
Application or New Drug Application filed as a result of activities under this
Agreement with the FDA, or the equivalent application to the equivalent agency
in any other country, the filing of which is necessary to market and sell a
Target Product, including all amendments and supplements to any of the
foregoing.

 

1.3          “Cost of Goods” shall mean the manufacturing cost of
either bulk or finished Target Product, as the case may be, as determined in
accordance with international accounting standards (IAS) applied consistently
throughout the organization of the Party or its Affiliate determining such
costs.  Cost of Goods shall consist of
[* * *]

1.4          “Competitive Product” shall mean, with respect to a given
Target Product sold in a given country of the Territory by Roche, its Affiliate
or sublicensee, a product  sold by a
Third Party in such country the regulatory approval for which in such country
specifically refers to and relies upon the Regulatory Approval dossier for such
Target Product in such country.

1.5          “Control” shall mean, with respect to any
information or intellectual property right, possession by a Party of the
ability (whether by ownership, license or otherwise) to grant access, a license
or a sublicense to such information or intellectual property right without
violating the terms of any agreement or other arrangement with any Third Party
as of the time such Party would first be required hereunder to grant the other
Party such access, license or sublicense.

1.6          “Confidential Information” shall have the meaning set forth in
Section 13.1.

1.7          “Development Activities” shall mean all activities relating to
obtaining Regulatory Approval of Target Product in the Territory which are
conducted pursuant to the Development Plan, including all activities relating
to developing the ability to manufacture the same.  This includes (a) preclinical testing, toxicology, formulation,
clinical studies, regulatory affairs and outside regulatory services and (b)
manufacturing

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

3

 

process development for Target Products, and
manufacturing and quality assurance technical support activities prior to the
First Commercial Sale of a Target Product.

 

1.8          “Development Costs” shall mean the costs other than Stressgen
RRP Development Costs, arising from Development Activities undertaken by
Stressgen or on its behalf and incurred by Stressgen for (a) CMC
activities related to Process B (as defined in Article 9) and performed on or
after [* * *] as the contract manufacturer of clinical supplies of Target
Product, but for the period defined between the Execution Date and [* * *] only
to the extent such costs do not exceed [* * *], (b) TC1 studies in support
of transitioning from Process A to Process B (as defined in Article 9), but
only to the extent such costs are for activities performed on or after [* * *]
and do not exceed [* * *] and (c) any other Development Activities
performed by Stressgen (other than for RRP) on or after [* * *] at the request
of the JDC.

Development Costs consist of (i) the costs for each Stressgen
full-time equivalent (“FTE”) involved in the foregoing activities; and
(ii) Third Party costs incurred by Stressgen, in each case in connection
with such Development Activities, each solely to the extent allocable to
Development Activities.  FTE costs by
Stressgen shall be calculated based upon a rate of 

[* * *] per FTE.

1.9          “Development Plan” shall mean the written plan describing
the non-clinical, clinical and manufacturing process development of the Target
Product to be carried out by Roche and Stressgen, as adopted pursuant to
Section 7.1.

1.10        “Diligent Efforts” shall mean the use of at least an
equivalent degree of effort and resources consistent with the exercise of
prudent scientific and business judgment, as applied to other pharmaceutical
products of similar potential and market size by the Party in question, and
reflecting the competitive environment for the development and marketing of
Target Product.

1.11        [* * *] shall mean [* * *] Stressgen’s contract
manufacturer of clinical supplies of Target Product as of the Execution Date,
and pursuant to that certain Bioprocessing Services Agreement, dated April 10,
2000.

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

4

 

 

1.12        “Effective Date” shall mean the date that all Conditions
Subsequent under Section 16.1 have occurred.

 

1.13        “End of Phase II” shall mean, for the Phase II Clinical
Trial, the date when database closure for the Phase II Clinical Trial occurs
following enrollment of the targeted patient population and completion of the
course of therapy as per the Development Plan for all targeted patients.

1.14        “Executive Officers” shall mean, for Roche, the Head of the
Roche Pharma Division (or a designee), and for Stressgen, the Chief Executive
Officer of Stressgen (or a designee).

1.15        “FDA” shall mean the United States Food and Drug
Administration.

1.16        “First Commercial Sale” shall mean, for each Target Product in
each country, the first sale to a Third Party of the Target Product in the
country by Roche or its Affiliates or sublicensees, after granting of
Regulatory Approval for the Target Product by the governing authorities of that
country.

1.17        “Genital Warts” shall mean any one or more of the
following indications: internal and external genital and perianal warts,
including those urethral, intravaginal, cervical, rectal and intra-anal sites.

1.18        “HPV Indication” shall mean treatment or prevention of any
human disease or disorder caused by any type of the human papilloma virus in
any anatomical site, other than treatment of diagnosed cancer.  For example, HPV Indication includes any one
or more of the following indications (treatment and/or prevention):  Genital Warts, benign and precancerous
lesions, cervical dysplasia, anal dysplasia, and/or recurrent respiratory
papillomatosis (“RRP”).

                1.19        “HspE7” shall mean any fusion protein containing (a) a
human papilloma virus (HPV) E7 antigen, or an antigenic fragment, mutein or
conjugate thereof, and (b) a bacterial stress protein, or a fragment,
mutein or conjugate thereof, including, in particular and without limitation,
that recombinant DNA derived fusion protein containing

 

 

5

 

 

 [* * *] amino
acids, derived from the 65kDa heat shock protein of mycobacterium bovis var. BCG
(Hsp65) coupled at the C-terminus to the E7 protein of human papilloma virus
(HPV) type 16.  HspE7 includes nucleic
acid sequences and vectors and host cells containing nucleic acid sequences
encoding such proteins contained therein.

 

1.20        “IND” shall mean an application to the FDA, the filing of
which is necessary to commence clinical testing of Target Products in humans,
or the equivalent application to the equivalent agency in any other country or
group of countries.

1.21        “Invention” shall mean any invention or discovery,
whether or not patentable, made as a result of activities of a Party or the
Parties pursuant to this Agreement, and which relates to a Target Product.  An “Invention” may be made by employees of
Stressgen solely or jointly with a Third Party (a “Stressgen Invention”), by
employees of Roche solely or jointly with a Third Party (a “Roche
Invention”), or jointly by employees of Stressgen and Roche with or
without a Third Party (a “Joint Invention”), in each instance as
determined by U.S. laws of inventorship.

1.22        “Major Market Country” shall mean the United States of America,
United Kingdom, France, Germany, [* * *.]

1.23        “Manufacturing Transfer Package” shall mean the information and materials
identified in that certain list entitled Manufacturing Transfer Package dated
as of the Execution Date and delivered to Roche.

1.24        “MIT Agreement” shall mean that certain License
Agreement dated November 3, 1992 between Massachusetts Institute of Technology
and the Whitehead Institute (collectively “MIT”) and Stressgen Biotechnologies
Corporation, as amended.

1.25        “Naïve Genital Warts” shall mean Genital Warts in adults that
have had no prior drug, ablative or surgical treatment.

1.26        “NCI
Agreements” shall
mean those certain Agreements dated October 5, 1999 and June 4, 2002
between National Cancer Institute and Stressgen Biotechnologies Corporation, as
amended.

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

6

 

1.27        “Net Sales” shall mean the amount remaining after
deducting from Adjusted Gross Sales an amount equal 

to [* * ].

 

As used herein,
the term “Adjusted
Gross Sales” shall mean the gross amount invoiced for sales of
Target Products to Third Parties in the Territory by Roche, its Affiliates and
their respective sublicensees to Third Parties that are not Affiliates or
sublicensees of the selling party, less the following items, as allocable to such
Target Product (if not previously deducted from the amount invoiced):

(a)           volume (quantity) discounts;

(b)           returns and return reserves  (including allowances actually given for spoiled, damaged,
out-dated, rejected, returned Target Product, withdrawals and recalls;

(c)           taxes, duties or other governmental tariffs, including
value added or sales taxes, government mandated exceptional taxes and other
taxes directly linked to the gross sales amount (other than income taxes); and

(d)           rebates (including price reductions, rebates to social
and welfare systems, chargebacks or reserves for chargebacks, cash rebate
incentives, government mandated rebates and similar types of rebates, for
example P.P.R.S, Medicaid).

Notwithstanding the
foregoing, amounts received by Roche or its Affiliates or sublicensees for the
sale of Target Product among Roche and its Affiliates or sublicensees for
resale shall not be included in the computation of Net Sales hereunder.

1.28        “Other HPV Fusion Protein” shall mean a fusion protein that contains
both (a) a human papilloma virus (HPV) antigen, or an antigenic fragment,
mutein or conjugate thereof, other than an HPV E7 antigen, or antigenic
fragment, mutein or conjugate thereof, and (b) a bacterial stress protein,
or a fragment, mutein or conjugate thereof. 
Other HPV Fusion Protein includes nucleic acid sequences and vectors and
host cells containing nucleic acid sequences encoding the protein contained
therein.

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

7

 

1.29        “Party” shall mean, individually, Stressgen or Roche, and “Parties”
shall mean collectively, Stressgen and Roche.

1.30        “Patents” shall mean (a) United States patents,
re-examinations, reissues, renewals, extensions and term restorations, and
foreign counterparts thereof, and (b) pending applications for United States
patents, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications,
including, without limitation, inventors’ certificates, and (c) any and all
foreign counterparts of (a) and (b).

1.31        “Phase II Clinical Trial” shall mean the dose ranging Phase II
trial (i.e., the second phase of human clinical trials required by the FDA to
gain evidence of efficacy of Target Product in a target population, and to
determine common short term side effects and risks for Target Product, as
described in 21 CFR Part 312(b), as it may be amended (or its successor
regulation) conducted by Roche pursuant to the Development Plan.

1.32        “Phase III Clinical Trial” shall mean the third phase of human
clinical trials required by the FDA to gain evidence of efficacy of Target
Product in a target population, and to obtain expanded evidence of safety for
Target Product that is needed to evaluate the overall benefit-risk relationship
of Target Product and provide an adequate basis for physician labeling, as
described in 21 CFR Part 312(c), as it may be amended (or its successor
regulation), conducted by Roche pursuant to the Development Plan.

1.33        “Refractory or Recurrent Genital Warts” shall mean Genital Warts that were
partially or completely non-responsive to or have recurred after, prior drug,
ablative or surgical treatment.

1.34        “Regulatory Approval” shall mean any and all approvals,
licenses, registrations or authorizations (including pricing and reimbursement
approvals) of any national or international or local regulatory agency,
department, bureau or other governmental entity, whether or not conditional,
that are necessary for the commercial

 

 

8

 

sale of a Target
Product in a regulatory jurisdiction in the Territory and obtained as a result
of activities under this Agreement.

1.35        “Start of Phase III” shall mean the date that a patient is
first dosed in a Phase III Clinical Trial for Target Product for an HPV
Indication, as a result of activities under this Agreement.

1.36        “Stressgen Know-How” shall mean, to the extent necessary or
useful for the manufacture, development or commercialization of Target Products
in the Territory, all data, knowledge and information Controlled by Stressgen
during the Term, including, without limitation, materials, samples, chemical
manufacturing data, toxicological data, pharmacological data, clinical data,
formulations, specifications, quality control testing data, and submissions and
correspondence to and from governmental agencies with regard to Target
Products, but excluding Stressgen Patent Rights.

1.37        “Stressgen Patent Rights” shall  mean all Patents that Stressgen Controls
as of the Execution Date or during the Term, including, without limitation,
Patents that claim Stressgen Inventions and/or Joint Inventions, which, in the
absence of the license granted to Roche under this Agreement, would be infringed
by the making, using, selling, offer for sale or importation of Target Products
in the Territory.  Exhibit A lists all Stressgen Patent Rights
existing as of the Execution Date (“Base Patents”).

1.38        “Stressgen RRP Development Cost” shall mean the costs  arising from Development Activities incurred
by Stressgen for RRP.

1.39        “Stressgen Technology” shall mean the Stressgen Know-How and the
Stressgen Patent Rights.

1.40        “Target Product” shall mean any product which contains
HspE7 for the treatment of any human condition or disease, including, without
limitation, all HPV Indications.

 

 

9

 

1.41        “Target Product-Specific Base Patent” shall mean those Patents identified in Exhibit A as “Product
Specific Patents and Patent Applications.”

1.42        “Term” shall mean, for each country of the Territory, the
period commencing on the Effective Date and, unless this Agreement is
terminated sooner as provided in Article 16, ending on the date when no payment
obligations under this Agreement are or will become due with respect to Net
Sales of Target Product in such country.

1.43        “Territory” shall mean all countries of the world.

1.44        “Third Party” shall mean any Person other than a Party,
its Affiliates and sublicensee.

1.45        “Third Party Right” shall mean a Patent owned or controlled
by a Third Party under which Roche or its Affiliate obtains a license to use,
offer for sale, sell or import Target Product in the Territory following an
opinion of competent legal counsel or an agreement of the Parties that risk
exists that a court could find that the use, offer for sale, sale or import of
HspE7 in the Territory infringes such Patent in the absence of such license.

1.46        “Valid Claim” shall mean a claim in any
(a) unexpired and issued Stressgen Patent Right that has not been
disclaimed, revoked or held invalid or unenforceable by a final unappealable
decision of a court of government agency of competent jurisdiction or
(b) pending patent application that is a Stressgen Patent Right which
patent application has been on file with the applicable patent office for no
more than [* * *] from the earliest date to which the patent application claims
its earliest priority.

ARTICLE 2

LICENSES

2.1          License Grant To Roche. 
Subject to the terms of this Agreement, (a) Stressgen grants, and
shall cause its Affiliates to grant, to Roche the sole and

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

10

 

exclusive (except as set forth below), right and
license, including a sublicense under the MIT Agreement, under the Stressgen
Technology to develop, use, offer for sale, sell and import Target Product in
the Territory excluding Canada; and (b) SBC grants, and shall cause its
Affiliates to grant, to Roche the sole and exclusive (except as set forth
below), right and license including a sublicense under the MIT Agreement, under
the Stressgen Technology to develop, use, offer for sale, sell and import
Target Product in Canada.

 

The exclusivity of the foregoing license shall be subject to the
retained right of Stressgen, SBC and their respective Affiliates to practice
the Stressgen Technology for the purpose of conducting development, manufacture
and commercialization of Target Products in the Territory to the extent expressly
contemplated by this Agreement.

Roche hereby acknowledges that Articles II, V, VII, VIII, IX, X, XII,
XIII and XV of the MIT Agreement shall be binding upon Roche, its Affiliates
and their respective sublicensees as if each of them were a party to the MIT
Agreement.  In particular, Roche agrees
and understands that Stressgen’s exclusive rights, privileges and license under
the MIT Agreement, and therefore Roche’s sublicense under the MIT Agreement
shall terminate upon expiration or abandonment of all issued patents and filed
applications within the Patent Rights (as defined in the MIT Agreement), unless
the MIT Agreement is earlier terminated in accordance with the provisions of
the MIT Agreement.  Such acknowledgement
is subject to the terms and conditions of this Agreement, in particular
Articles 15 and 17.  Roche hereby
acknowledges that Stressgen’s license under the MIT Agreement is expected to
terminate on [* * *]

2.2          Sublicensees. 
The rights and licenses granted to Roche under Section 2.1 shall
include the right to grant sublicenses to its Affiliates and Third Parties
under such rights and licenses, in whole or in part.  If Roche grants such a sublicense, Roche shall ensure that all of
the applicable terms and conditions of this Agreement shall apply to the
Affiliate or Third Party sublicensee to the same extent as they apply to Roche
for all purposes.  Roche assumes full
responsibility for the performance of all obligations so imposed on such
Affiliate or Third Party sublicensee and will itself

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

11

 

account to Stressgen for all payments due under this
Agreement by reason of such sublicense. 
Any sublicenses granted under this Section 2.2 by Roche shall terminate
upon the early termination of this Agreement, to the extent this Agreement
becomes terminated; and shall convert to non-exclusive upon expiration, in
conformance with Section 16.2.

 

Notwithstanding the
foregoing, Roche shall not have the right to sublicense the rights granted
pursuant to Section 2.1 above to any Third Party in a Major Market Country,
except upon the prior written approval of Stressgen, which approval Stressgen
shall not unreasonably withhold.

2.3          Transfer of Stressgen Know-How. 
Following the Effective Date and from time to time throughout the Term,
as reasonably requested by Roche, Stressgen shall make available to Roche such
Stressgen Know-How then in Stressgen’s possession or Control as is reasonably
necessary for Roche to exercise the license granted to it under this Agreement.

2.4          Other HPV Fusion Proteins. 
Until the expiration or early termination of this Agreement, on a
country by country basis, neither Stressgen nor SBC, nor any of its Affiliates,
will pursue clinical development or commercialization of any product containing
an Other HPV Fusion Protein for any or all of the HPV Indications, nor shall
Stressgen or any of its Affiliates grant any license or other rights to any
Third Party with respect to the clinical development or commercialization of
any product containing an Other HPV Fusion Protein for any or all of the HPV
Indications.  Notwithstanding anything
to the contrary herein, it is further expressly understood and agreed that
Stressgen and its Affiliates shall at all times retain the right to pursue
clinical development or commercialization of products containing an Other HPV
Fusion Protein for any indication outside of the field of HPV Indication, such
as treatment of diagnosed cancer, and/or to grant licenses or other rights to
Third Parties with respect to the clinical development or commercialization of
products containing an Other HPV Fusion Protein for any such indication.

 

 

12

 

ARTICLE 3

INITIAL AND DEVELOPMENT EVENT PAYMENTS

 

3.1          Technology Development Payment. 
Roche shall make a payment to Stressgen of [* * *] within ten (10) days
after (a) the Effective Date and (b) receipt by Roche of an invoice
for such amount.  Such payment shall be
non-refundable and non-creditable.

3.2          Equity Investments in Stressgen. 
Contemporaneously with the execution of this Agreement, SBC and Roche or
its Affiliate shall enter into the Equity Agreement, pursuant to which Roche or
its Affiliate shall purchase up to an aggregate of Five Million dollars
($5,000,000) of common stock of Stressgen and be issued warrants to purchase
Two Million dollars ($2,000,000) of Stressgen common stock and Three Million
dollars ($3,000,000) of Stressgen common stock (collectively, the “Warrants”) upon
such terms and conditions, including price per share, as are set forth in such
Equity Agreement and the Warrants.

3.3          Development Event Payments. 
In consideration for Stressgen’s collaboration under this Agreement,
including its co-development of the Target Product, Roche shall pay to
Stressgen the following one-time, nonrefundable and non-creditable amounts,
within [* * *] after the first occurrence of each of the following events, with
respect to the first Target Product to achieve the respective event:

	
  Event

  	
   

  	
  Payment

  (millions of dollars)

  	
   

  
	
  1

  	
   

  	
  [*] and receipt by
  Roche of an invoice for such amount

  	
   

  	
  [*]

  	
   

  
	
  2

  	
   

  	
  [*] and receipt by
  Roche of an invoice for such amount

  	
   

  	
  [*]

  	
   

  
	
  3

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  4

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  5

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  6

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  7

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  8

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  9

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  10

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

13

 

Notwithstanding the
foregoing, in the event US Regulatory Approval for [*] is limited to approval
only for [*], then the [*] referred to above shall instead be adjusted as
follows:  (a) in the case of [*]
only, [*] and (b) in the case of [*] [*] provided, however that in
the event that indication which was not approved at such time is later
approved, then Roche would at that time pay a separate event payment to
Stressgen equal to the difference between [*] and the amount already paid for
the first of [*] or [*] to be approved.

Notwithstanding anything
herein to the contrary, Roche shall make each of such payments in this Section
3.3 only once for the first occurrence of a respective event.  All payments made under this Section 3.3 are
non-refundable and non-creditable.

3.4          Commercial
Success Payments.  In consideration for Stressgen’s
participation in the development and commercialization of Target Products
hereunder, Roche shall pay to Stressgen the following one time, nonrefundable
and non-creditable amounts, within thirty (30) days after [* * *] referred to
in the chart below for each of the following events with respect to the
cumulative worldwide Net Sales of the Target Product over [* * *]:

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

14

 

 

	
  Commercial Event

  	
   

  	
  Amount
  (millions of dollars)

  	
   

  
	
  Where aggregate Net
  Sales of Target Products in the Territory reach [*] as measured by the
  cumulative Net Sales during [*] ending on or prior to [*] after First
  Commercial Sale

  	
   

  	
  [*]

  	
   

  
	
  Where aggregate Net
  Sales of Target Products in the Territory reach [*] as measured by the
  cumulative Net Sales during [*] ending on or prior to [*] after First
  Commercial Sale

  	
   

  	
  [*]

  	
   

  
	
  Where aggregate Net
  Sales of Target Products in the Territory reach [*] as measured by the
  cumulative Net Sales during [*]

  	
   

  	
  [*]

  	
   

  
	
  Where aggregate Net
  Sales of Target Products in the Territory reach [*] as measured by the
  cumulative Net Sales during [*]

  	
   

  	
  [*]

  	
   

  

Notwithstanding anything herein to the contrary, Roche
shall make each of such payments in this Section 3.4 only once for the first
occurrence of a respective event.  In
the event Net Sales in a given period of [*] grow from less than one milestone
threshold amount (e.g., just below [*]) past a second threshold amount [*] then
Stressgen shall be paid both milestones achieved during such [*] period.

ARTICLE 4

PAYMENTS BASED ON SALES OF TARGET PRODUCTS

4.1          Payments to Stressgen Based upon
Worldwide Net Sales.  In consideration for Stressgen’s
co-development and commercialization activities under this collaboration and
the rights of Roche to commercialize and manufacture Target Product as provided
in this Agreement, and subject to the terms and conditions of this Agreement,
Roche shall make payments to Stressgen based upon the volume of Target Product
sold by Roche, its Affiliates and sublicensees in the Territory, as set forth
in this Section 4.1, taking into account the adjustments as provided in
Sections 4.3, 4.4, and 4.5. 
Accordingly, Roche shall pay to Stressgen the following payments, based
upon the worldwide Net Sales of Target Products, which such Net Sales shall be
subject to adjustment as provided in this Article 4. Such sales-based payments
shall be calculated by multiplying the following percentages by the following
incremental annual worldwide Net Sales of Target Products in the Territory (all
Net Sales amounts in $ US million):

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

15

 

 

	
  Incremental annual worldwide Net
  Sales

  	
   

  	
  Percent
  (%) of Net Sales

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  

By way of
illustration, assume in calendar year 2008 that (a) Net Sales of Target Product
in the Territory total [*] and (b) no adjustments or deductions to payments
under this Article 4 apply.  The
sales-based payments due and payable by Roche to Stressgen for the calendar
year would be $[*], calculated as follows:

 

	
  Increment of Net Sales (in millions)

  	
   

  	
  Applicable Sales-Based 

  Payment Percentage

  	
   

  	
  Amount Payable (in millions)

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  

4.2          Termination of Sales Based Payments.  Roche shall calculate and pay sales-based
payments to Stressgen under this Article 4 commencing on the First Commercial
Sale in the Territory.  The Net Sales of
a given country shall be included in aggregate world wide Net Sales until the
later of (a) expiration of the last to expire of the Stressgen Patent
Rights containing a Valid Claim in such country and (b) [* * *] from the
First Commercial Sale of such Target Product in such country (the “Sales-Based
Payment Term”).

4.3          Adjustments Related to No Valid Claims. 
Subject to Section 4.7, for each country of the Territory in which no
Valid Claim exists for the Target Product, Roche shall have the right to
include in aggregate worldwide Net Sales only [* * *] of the actual Net Sales
of Target Products in such country.

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

16

 

4.4          Adjustments Related to Third Party
Competition.  If in a country of the Territory in which no
Valid Claim of a Target Product-Specific Patent exists for the Target Product,
and (a) a Third Party is selling Competitive Product, (b) Roche has
an obligation to make payments under this Agreement with respect to Net Sales
of such Target Products in such country, and (c) in such country, sales of
units of Competitive Products in aggregate total at least [* * *] of the
aggregate sales of units of Competitive Products and Target Products as
measured at the end of [* * *], then Roche shall have the right to calculate
sales-based payments by including only [* * *] of the amount Roche would have
otherwise included for such country to calculate sales-based payments if no
Competitive Product existed in such country, subject to Section 4.7.

4.5          Adjustments Related to Third Party
Payments.  Roche or its Affiliate shall pay and be
responsible for the entire consideration owed to any Third Party pursuant to
the terms of any licensing arrangement related to a Third Party Right, but
shall keep Stressgen informed as reasonably requested by Stressgen regarding
progress of negotiations with such Third Party regarding such licensing
arrangement.  Roche shall have the right
to deduct a maximum of [* * *] of the consideration actually paid to a Third
Party with respect to such Third Party Right (“Deductible Consideration”) from
payments otherwise due and payable by Roche to Stressgen under this Article 4,
solely to the extent such Deductible Consideration is allocable to HspE7.  In no event shall the sales-based payment
owed to Stressgen under this Article 4 be reduced in any given year below the
greater of (a) [* * *] of that otherwise due and owing or (b) [* * *]
of worldwide Net Sales in the Territory.

4.6          Payments Under the MIT Agreement.  Notwithstanding anything to the contrary
herein, the Parties acknowledge that Stressgen and MIT have entered into the
MIT Agreement, as it is and may be further amended.  Subject to Section 4.2, Stressgen or SBC, as the case may be,
shall directly pay MIT any amounts due to MIT under such agreement, and such
amounts shall not affect or be offset against the sales-based payments owing
from Roche to Stressgen under this Agreement.

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

17

 

4.7          Maximum Adjustments. 
In no event shall Roche, for any Target Product in any country in the
Territory, reduce the amount payable to Stressgen hereunder to less than [* *
*] of Net Sales of such Target Product, on account of adjustments under this
Article 4.

4.8          Combination Products. 
In the event Roche or its Affiliates sell a product which is comprised
of the Target Product as well as, other pharmaceutically active agent(s) (a “Combination
Product”), the Parties shall meet approximately one (1) year prior
to the anticipated commercial launch of such Combination Product to negotiate
in good faith and agree to an appropriate adjustment to Net Sales to reflect
the relative significance and value of the Target Product and the other
pharmaceutically active agent(s) contained in the Combination Product.  If, after good faith negotiations (not to
exceed ninety (90) days), the Parties cannot agree to an appropriate
adjustment, Net Sales shall equal Net Sales of the Combination Product
multiplied by a fraction, the numerator of which is the reasonable fair market
value of the Target Product and the denominator of which is the reasonable fair
market value in the aggregate, of all pharmaceutically active agents contained
in the Combination Product; provided, however, that, for the purposes
of the foregoing calculation, in no event shall the fair market value of the
Target Product in any Combination Product be less than [* * *] of the fair
market value of all pharmaceutically active agents contained in such
Combination Product.

ARTICLE 5

PAYMENT, REPORTING, AUDITING

5.1          Currency and Conversion.

(a)           All payments under this Agreement shall be in U.S.
Dollars.

(b)            Whenever calculation of Net Sales requires conversion
from any foreign currency, Roche shall convert the amount of Net Sales in
foreign currencies as computed in the Roche’s central Swiss Francs Sales
Statistics for the countries concerned. 
Roche shall first convert the amount of Net Sales into Swiss Francs and

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

18

 

 

then into U.S. Dollars, using the average year-to-date
rate of exchange for such currencies as retrieved from the Reuters’ system for
the applicable period, in accordance with Roche’s then current standard
practices.

 

(c)           For sublicensees in a country, when calculating the Net
Sales, the sublicensee shall report to Roche the amount of such sales within
thirty (30) days from the end of the reporting period, after having converted
each applicable monthly sales in foreign currency into Swiss Francs using the
average rate of exchange published in the Wall Street Journal (or some other
source agreed upon by the Parties for any particular country) for each
respective month of the reporting period.

5.2          Sales-Based Payments. 
After the First Commercial Sale of the Target Product in any country of
the Territory, Roche shall calculate sales-based payments set forth in Article
4 quarterly as of March 31, June 30, September 30 and December 31 (each being
the last day of a reporting period). 
Roche shall pay such payments quarterly within sixty (60) days after the
end of each reporting period in which Net Sales occur during the Term.

With each such payment,
Roche shall deliver to Stressgen the following information split between U.S.
and rest of world:

(a)           Adjusted Gross Sales for Target Product;

(b)           Net Sales for 
Target Product;

(c)           the sales-based payments due to Stressgen for the
reporting period;

In the event Roche does not pay to Stressgen any amounts due under this
Agreement within the applicable time period set forth herein, such payment
shall bear interest, to the extent permitted by applicable law, at [* * *]
calculated on the number of days such a payment is overdue.

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

19

 

5.3          Taxes.

(a)           Stressgen or SBC, as the case may be, shall pay all
applicable taxes levied on account of payments accruing or made to Stressgen
under this Agreement.

(b)            If provision is made in law or regulation of any
country for withholding of taxes of any type, levies or other charges with
respect to any amounts payable under this Agreement to Stressgen, Roche shall
promptly pay such tax, levy or charge for and on behalf of Stressgen to the
proper governmental authority, and shall promptly furnish Stressgen with
receipt of such payment.  Roche shall
have the right to deduct any such tax, levy or charge actually paid from
payment due Stressgen or be promptly reimbursed by Stressgen if no further
payments are due Stressgen.  Each Party
agrees to assist the other Party in claiming exemption from such deductions or
withholdings under double taxation or similar agreement or treaty from time to
time in force and in minimizing the amount required to be so withheld or
deducted.

5.4          Blocked Countries. 
If by reason of law Roche is unable to convert to U.S. dollars a portion
of the amount due by Roche under this Agreement, then Roche shall notify
Stressgen in writing and Stressgen shall have the right to receive such portion
and, upon written request from Stressgen, Roche shall pay to Stressgen such
portion, in the currency of any other country designated by Stressgen and
legally available to Roche.

5.5          Accounting.

                (a)           Roche shall maintain and cause its Affiliates and sublicensees to
maintain books of account containing all particulars that may be necessary for
the purpose of calculating all payments under this Agreement.  Such books of account shall be kept at their
principal place of business. Stressgen shall have the right to engage Roche’s
independent, certified public accountant to perform, on behalf of Stressgen, an
audit, conducted in accordance with International Accounting Standards (“IAS”),
of such books and records of Roche and its Affiliates and sublicensees as is
necessary to

 

 

 

20

 

 

confirm any amounts payable to Stressgen under this
Agreement for the period or periods requested by Stressgen and the correctness
of any report or payments made under this Agreement.

 

(b)           Such audits shall be conducted during normal business
hours upon reasonable prior written notice from Stressgen (minimum of thirty
(30) days) in such a manner as to not unnecessarily interfere with Roche’s
normal business activities, and shall include results of no more than [* * *]
preceding calendar years prior to audit notification.  Stressgen shall have a right to request from the independent
certified public accountant full access to review all work papers and
supporting documents pertinent to such audit.

(c)           Such audit shall not occur more frequently than once
per calendar year nor more frequently than once with respect to records
covering any specific period of time. 
Notwithstanding the preceding, if Stressgen reasonably believes, after
reviewing information received from Roche’s independent public accountant, that
an additional audit is appropriate to address an apparent discrepancy between
Roche’s returns and other information as is necessary for reporting hereunder,
Stressgen shall have the right, by an audit specialty firm acceptable to Roche,
employed by Stressgen and at Stressgen’s own expense, to perform such necessary
audit procedures.

(d)           The use of all information, data, documents and
abstracts referred above shall be for the sole purpose of verifying  statements or compliance with this
Agreement, shall be treated as Roche Confidential Information subject to the
obligations of this Agreement and, except in the event of a dispute between the
Parties regarding amounts payable hereunder or the results of any audit, need
not be retained more than [* * *] from the end of the calendar year to which
each shall pertain.  Audit results shall
be shared by Roche and Stressgen.

(e)           If any audit hereunder reveals an underpayment, Roche
shall promptly make up such underpayment, and if such underpayment is more than
[* * *], together with accrued interest calculated in accordance with Section
5.2.  Stressgen shall bear the full cost
of any audit under this Section 5.5, unless such audit discloses

 

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

21

 

 

an underpayment by Roche of more than [* * *] of the
amount owed hereunder, in which case Roche shall bear the full cost of such
audit as performed by Roche’s independent, certified public accountant, and/or
such independent audit firm as may be used pursuant to Subsection (c) above.

 

(f)            The failure of Stressgen to request verification of
any payment calculation during which corresponding records are required to be
retained under this Section 5.5 shall be considered acceptance of such
reporting by Stressgen.

ARTICLE 6

COLLABORATION GOVERNANCE

6.1          Steering Committee. 
In furtherance of their collaboration, the Parties shall establish a
Steering Committee of three (3) representatives from each Party.  Each Party shall within thirty (30) days
after the Execution Date select its initial representatives and set a date
shortly thereafter for the first meeting of such Steering Committee.  Each Party may replace its representatives
at any time on prior written notice to the other Party.  The Chairperson of the Steering Committee
shall alternate between the Parties on annual calendar year (January 1 —
December 31) basis, with the first chairperson being from Roche and having a
term running until December 31, 2002. 
The Chairperson shall be responsible for providing an agenda for each
meeting at least ten (10) days in advance of such meeting.  The Party not chairing the Steering
Committee shall prepare written draft minutes of all meetings in reasonable
detail and distribute such draft minutes to all members of the Steering
Committee for comment and review within twenty (20) days after the relevant
meeting.  The Steering Committee members
shall have ten (10) days to provide comments. 
The Party preparing the minutes shall incorporate timely received
comments and distribute finalized minutes to all members of the Steering
Committee within thirty (30) days of the relevant meeting.

6.2          Joint Development Committee.  In addition, in order to coordinate the
activities of the Parties in the development for commercialization of the
Target Product, the Parties shall establish a Joint Development Committee (“JDC”).  The JDC will consist of three (3)
representatives from each Party.  Each
Party shall within thirty (30)

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

22

 

 

days after the Execution Date select its initial
representative(s) and set a date shortly thereafter for the first meeting of
such JDC.  Each Party may replace its
representative(s) at any time on prior written notice to the other Party.  The Chairperson of the JDC shall alternate
between the Parties on annual calendar year (January 1 — December 31) basis,
with the first chairperson being from Stressgen and having a term running until
December 31, 2002.  The Chairperson
shall be responsible for providing an agenda for each meeting at least five (5)
days in advance of such meeting.  The
Party not chairing the JDC shall prepare written draft minutes of all meetings
in reasonable detail and distribute such draft minutes to all members of the
JDC for comment and review within ten (10) days after the relevant
meeting.  The JDC members shall have ten
(10) days to provide comments.  The
Party preparing the minutes shall incorporate timely received comments and
distribute finalized minutes to all members of the JDC and the Steering
Committee within thirty (30) days of the relevant meeting.

 

6.3          Finance Subcommittee. 
Each Party shall also appoint a representative with expertise in
financial accounting, cost allocation, budgeting and financial reporting (“Finance
Subcommittee”) to work under the direction of the Steering Committee
and provide services and consult with the Steering Committee addressing
financial, budgetary and accounting issues that arise in connection with the
collaboration hereunder, in particular with respect to the Development Plan.

6.4          Manufacturing Transition Team. 
Each Party shall also appoint representatives with expertise in
pharmaceutical manufacturing (“Manufacturing Transition Team”) to work
under the direction of the JDC and coordinate transition of the Manufacturing
Transfer Package to Roche.

6.5          Meetings and Responsibilities of the
Steering Committee.  The Steering Committee shall meet at least
two (2) times per year during the Term, with at least one (1) meeting during
each year in person (the location of each meeting in person to alternate
between the offices of each Party), for so long as the Development Plan
contemplates clinical development of Target Product in the Territory for the
purpose of obtaining, expanding or maintaining Regulatory Approval in a country
of the

 

 

 

23

 

 

Territory and
continuing until completion of all commercial launches of the Target Product in
the Territory.  The Steering Committee
shall have the authority to determine 
the following:

(a)           decide upon updates and modifications to the
Development Plan, as necessary;

(b)           decide upon budget issues, including addressing
significant variances from the approved annual budget and assessing actual
costs incurred to date vs. budget;

(c)           decide upon strategy with respect to each clinical and
regulatory issue related to Target Product in any country of the Territory;

(d)           decide upon a plan for each clinical trial program for
Target Product prior to the start of any such clinical trial, subject to
Section 7.3;

(e)           as necessary, decide to allow permission for a Third
Party clinical investigator to conduct proof of concept clinical trials for
Target Product not called for under the Development Plan, including for
additional indications for Target Product not then currently under the
Development Plan;

(f)            decide upon standards for calculating, accounting for
and auditing Development Costs, and Stressgen RRP Development Costs;

(g)           if necessary, decide whether to use Stressgen as a
secondary source of supply;

(h)           resolve any matters discussed and not agreed upon at
the JDC; and

(i)            perform such other functions as the Parties may agree
in writing.

6.6          Meetings and Responsibilities of the
JDC. 
The JDC
shall communicate frequently and outside formal meetings.  The JDC will meet in person at least two (2)

 

24

 

times per year
during the Term, for so long as the Development Plan contemplates clinical
development of Target Product in the Territory for the purpose of obtaining,
expanding or maintaining Regulatory Approval in a country of the
Territory.  The location of the
in-person meetings shall alternate between the offices of each Party.  At each meeting, the JDC shall discuss and
make recommendations to the Steering Committee, and/or if indicated below,
determine or approve, the following, among other matters:

(a)           clinical development endpoints, including deciding
upon a clinical development endpoint for identification and validation of a
pharmacodynamic marker;

(b)           managing of clinical and regulatory activities;

(c)           managing CMC activities;

(d)           allocation of clinical supply for clinical trials
across the Territory;

(e)           direct the Manufacturing Transition Team and
coordinate transition of the Manufacturing Transfer Package;

(f)            possible updates or modifications to the Development
Plan, including review of the initial Development Plan;

(g)           review of possible Inventions made in the conduct of
the Development Plan;

(h)           provide input to, analyze the progress of, and
otherwise approve the continuation of, the Other Stressgen Development
Activities (as defined in Section 7.3(d);

(i)            determining whether, and when to include any of the
Other Stressgen Development Activities in the Development Plan, as necessary;

 

 

25

 

(j)            approving Third Parties proposed to perform
Development Activities for RRP;

(k)           with respect to the Other Stressgen Development Activities,
defining procedures to ensure required reporting of any adverse events from
these trials;

(l)            as necessary, consider and request Stressgen to
conduct Roche Development Activities; and

(m)          performance of such functions as the Parties agree in
writing are appropriate for the JDC to perform.

6.7          Decisions.

(a)           Unanimous Decisions.  All
decisions made by the JDC and the Steering Committee must be by unanimous vote,
with each Party’s representatives collectively having one vote.

(b)           JDC Disputes.  If
a dispute or issue arises regarding any matter for which the JDC has the right
to make a decision, and such matter is not resolved within ten (10) days, the
JDC shall submit such dispute or issue for resolution to the Steering
Committee.

(c)           Steering Committee Disputes. 
If a dispute or issue arises regarding any matter for which the Steering
Committee has the right to make a decision, and such matter is not resolved
within thirty (30) days by the Steering Committee, it shall submit the dispute
or issue for resolution by the Executive Officers.  The Executive Officers shall have a period of thirty (30) days
from submission to resolve the dispute or issue.

(d)           Final
Decision Making Authority.  If the Executive Officers are unable to resolve the
dispute or issue within the thirty (30) day period, then final decision
regarding the dispute or issue shall [* * *].

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

26

 

ARTICLE 7

DEVELOPMENT PLAN AND CONDUCT OF DEVELOPMENT ACTIVITIES

 

7.1          Development Plan.  The Parties have held initial discussions
with respect to and preliminarily agreed upon an initial Development Plan.  Only the Steering Committee shall have the
right to modify the Development Plan (including work and timelines), as
described below.  The Parties anticipate
that promptly following the Execution Date and the formation of the JDC and the
Steering Committee, the JDC shall review the initial Development Plan in detail
and propose appropriate revisions thereto for adoption by and approval of the
Steering Committee.  The Development
Plan shall govern all development of Target Products in the Territory, except
as provided in Section 7.3(d).

7.2          Goals of Development.  The Parties hereby acknowledge and agree
that goals for development of Target Products hereunder will be to obtain
Regulatory Approval for (i) the treatment of [* * *] (ii) such [* * *][* * *],
(iii) other 

[* * *], and (iv) Target Products for the treatment of [* * *].

7.3          Conduct and Funding of Development
Activities.

(a)           Roche Obligations.  Subject to Sections 7.3(c) and 7.3(d),
commencing on the Effective Date, Roche will conduct all Development Activities
(the “Roche
Development Activities”).  To
the extent Roche wishes to use a Third Party to conduct any such Development
Activity, the JDC shall first consider Stressgen to perform such Activity.

(b)           Development Costs.  To the extent Roche conducts Development
Activities by itself or using a Third Party, Roche shall  bear all costs associated
with the Roche Development Activities. 
In addition, Roche shall reimburse Stressgen Stressgen’s Development
Costs, on a quarterly basis, within thirty (30) days of receipt of invoice from
Stressgen.  Such invoice shall include
reasonable documentation which itemizes and explains the Development Costs
incurred by Stressgen.  Any undisputed
amount which is not paid by such thirty (30) days from receipt of invoice shall
bear

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

27

 

interest, to the
extent permitted by applicable law, at [* * *], calculated on the number of
days such a payment is overdue.

(c)           RRP Indication. 
Stressgen will conduct Development Activities related to RRP which are
other than preparation and submission of regulatory dossiers.  Stressgen shall bear all Stressgen RRP
Development Costs  up to a maximum of [*
* *].  To the extent Stressgen RRP
Development Costs exceed [* * *], the Parties must agree in writing for a plan
for sharing the excess costs associated with such Development Activities or
such Development Activities shall cease. 
Roche shall be responsible for the preparation and submission of
regulatory dossiers with respect to RRP and shall bear all associated
costs.  Stressgen shall not be responsible
for reimbursement to Roche of any costs incurred in connection with the
development of RRP, including any activities with respect to clinical,
regulatory or other development activities. 
The Finance Subcommittee shall recommend for adoption by the Steering
Committee standards with respect to accounting for and auditing such Stressgen
RRP Development Costs, with the proviso that such standards shall be easily
implemented within the constraints of Stressgen’s reporting and accounting
system.

(d)           Other Stressgen Development
Activities.  The Parties agree and acknowledge that, as of the
Execution Date, (i) Stressgen or its Affiliate is a party to the NCI Agreements
under which Stressgen has agreed to supply National Cancer Institute (NCI)
clinical grade HspE7 materials for clinical trials for [* * *] to be sponsored
and conducted by NCI, provided the trials conducted by NCI are pursuant to
protocols approved by Stressgen; (ii) Stressgen has granted permission to a
Third Party clinical investigator, as set forth on Exhibit B, to conduct
clinical trials for cervical dysplasia, and (iii) Stressgen is in the process
of itself conducting, and subject to JDC approval (such approval not to be
unreasonably withheld in the event such decision escalates to Roche for final
decision), shall have the right to continue to conduct, clinical trails related
to [* * *] specifically set forth on Exhibit B (collectively, the “Other
Stressgen Development Activities”). 
For such activities, which are not part of the Development Plan and so
not a Development Activity, Stressgen shall be responsible for all associated
costs, including costs associated with the conduct of clinical trials and

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

28

 

 

as per Article 9, for the supply of clinical grade
Target Product necessary therefor in connection with such Other Stressgen
Development Costs.  If the JDC decides
to include one or more of such Other Stressgen Development Activities in the
Development Plan, then (i) thereafter they shall be deemed to be Roche
Development Activities and funded entirely by Roche and (ii) Roche shall
reimburse Stressgen all of Stressgen’s costs associated with the Other
Stressgen Development Activities to the extent such activity occurred after the
Execution Date.  Stressgen shall have
the right, at any time following the Execution Date, to terminate any or all of
the Other Stressgen Development Activities, without the approval or consent of
Roche.  Pursuant to the NCI Agreements
or otherwise, there is no obligation on the part of Stressgen to use the data
resulting from any clinical trial conducted thereunder in support of a BLA
Filing.

 

(e)           Use of Third Parties.  Subject to JDC approval, Stressgen shall
have the right to use, Third Parties to provide or perform Development
Activities for RRP.  Payments to such
Third Parties shall be included in the Stressgen RRP Development Costs.  Stressgen shall remain liable for the
performance of its obligations hereunder which it delegates to any such Third
Party provider.

(f)            Accounting Disputes.  Any accounting disputes arising between
the parties with respect to Development Costs shall be submitted to the Finance
Subcommittee for resolution.  In the
event the Finance Subcommittee cannot resolve such matter in thirty (30) days,
it shall be referred to the Steering Committee.

7.4          Standards of Conduct.  Each Party or its third party contractors
shall perform the Development Activities for which it is responsible under the
Development Plan in good scientific manner and in compliance with applicable
laws, rules and regulations.  At each
JDC meeting, each Party will keep the JDC fully informed regarding the progress
and results of such Party’s development activities with respect to Target Products
in the Territory.

7.5          Diligent Development.  Roche shall use Diligent Efforts to
achieve the goals set forth in Section 7.2. 
Each of the Parties agrees to cooperate with the other in carrying out
the Development Plan.

 

 

29

 

7.6          Development Limitations.  Except for any trials conducted pursuant
to the NCI Agreement or the independent investigator referenced in Section
7.3(d), neither Party may conduct or have conducted on its behalf, or enable
any Third Party to conduct, any clinical activities for Target Product not
approved under the Development Plan or by the JDC.  Notwithstanding the preceding, (a) the Steering Committee
shall have the right to decide to allow permission for any other Third Party
clinical investigator to conduct proof of concept clinical trials for Target
Product not called for under the Development Plan, including for additional
indications for Target Product not under the Development Plan, (b) Roche
shall have the right to, for a given country, conduct or have conducted on its
behalf post Regulatory Approval clinical studies for a Target Product for an
indication that was the subject of Regulatory Approval in such country,
provided such studies are other than to obtain, expand and/or maintain
Regulatory Approval of such indication in such country for the Target Product,
and (c) Stressgen shall have the right to conduct or have conducted Other
Stressgen Development Activities.

7.7          Updating the Development Plan. 
The Steering Committee may decide to update the Development Plan on a
rolling basis whenever needed if changes in the Development Plan so require
such update.  In any event, on an annual
basis by October 15 of each year until the date when the Steering Committee no
longer intends to develop Target Product in the Territory,  the Steering Committee shall confirm or
change the Development Plan.  Any
proposed change shall include, for the appropriate time period as determined by
the Steering Committee, a plan of development activities, their associated
budget, and timelines for performing such development activities.

ARTICLE 8

DEVELOPMENT — REGULATORY AND SAFETY

8.1          Assignment of INDs, Other
Documentation to Roche.  Promptly following the Effective Date, Stressgen shall
provide Roche with copies of all correspondence with the regulatory agencies
regarding Target Products.  Within
thirty (30) days after the Effective Date, Stressgen shall transfer and assign
to Roche all INDs

 

30

 

in its possession
and control with respect to Target Product. 
In addition, Stressgen shall transfer and assign to Roche any drug
master files or other regulatory dossiers containing information necessary or
useful to Roche in connection with its regulatory filings for Target Product,
within thirty (30) days after the Effective Date.  Stressgen shall provide Roche with all historical adverse event
reports on the Target Product at the time of IND transfer.

8.2          Responsibility for Regulatory Affairs. 
From and after the date of transfer of the INDs to Roche, and consistent
with the Development Plan, Roche shall be responsible for all regulatory
affairs in the Territory related to Target Product, including the preparation
and filing of applications for Regulatory Approval, as well as any or all
governmental approvals required to manufacture, or have manufactured, Target
Product.  Roche shall file all such
applications in its own name, or that of its Affiliate.  Roche and shall provide a copy of any BLA
filing for RRP in the US for a Target Product to Stressgen for its comment
prior to filing with the FDA.  In
addition, Roche shall provide to Stressgen reasonable written notice of all
meetings and conference telephone calls with the FDA related to Target Products
for the United States and for RRP Stressgen shall have a right have one person
attend as a silent observer.  Roche
shall provide to Stressgen copies of all correspondence and final filings
(including, without limitation, IND filings and BLA Filings) related to Target
Product with regulatory authorities in all countries of the Territory promptly
(and in any event within thirty (30) days) following receipt or filing, as
applicable.

                8.3          Drug Safety.  Roche shall
be responsible for reporting, at its expense, to appropriate authorities in
accordance with local requirements all adverse events related to use of Target
Product worldwide, except that prior to Stressgen transferring ownership of
IND(s) to Roche pursuant to Section 8.1, Stressgen shall be responsible for the
reporting of such adverse events, at Stressgen’s expense.  Adverse events related to the use of Target
Product worldwide shall be in a single database, centralized, held and owned by
Roche.  The Parties shall develop
procedures by which the Parties shall have coordinated efforts to assure proper
reporting of all adverse events.  With
respect to the Other Stressgen Development Activities, the JDC shall

 

 

 

31

 

 

promptly define procedures to ensure required reporting
of any adverse events from these trials.

 

8.4          Product Withdrawals. 
In the event that any regulatory agency in the Territory threatens or
initiates any action to remove a Target Product from the market, Roche shall
promptly notify Stressgen in writing of receipt of such notice by Roche.

8.5          Mutual Covenants. 
Each Party covenants the following:

(a)           That it shall comply in all material respects with all
federal, state, provincial, territorial, governmental and local laws, rules and
regulations applicable to the development, manufacture and commercialization of
Target Product by such Party.

(b)           That it shall disclose immediately to the other Party
all information in its possession or control and as to which it becomes aware
concerning side effects, injury, toxicity or sensitivity reaction and incidents
or severity thereof with respect to Target Product.

ARTICLE 9

MANUFACTURE AND SUPPLY

9.1          [* *
*] Transition to New Manufacturing Process.
Roche understands and acknowledges that as of the Execution Date, pursuant to
an agreement with Stressgen, [* * *] manufacturer for clinical supplies of
Target Product.  In addition, the
Parties understand and acknowledge that, as of the Execution Date, Stressgen is
in the process of transitioning the manufacture of clinical grade Target
Product from an earlier process (“Process A”)
to a newer process (“Process B”),
working in conjunction with [* * *].  As
used in this Article 9, clinical grade Target Product manufactured using
Process A shall be referred to as the “Process
A Target Product,” and clinical grade Target Product manufactured
using Process B (or any subsequent process or variant thereof) shall be
referred to as “Process B Target Product.”

9.2          Clinical Supplies of Process B Target
Product. Roche shall
supply in finished form all clinical supply of Process B Target Product and
placebo  to
be used in the Territory during the Term, either by itself, or through a Third
Party.  Stressgen shall

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

32

 

maintain in full
force and effect all agreements and relationships with [* * *] and any other
Third Party necessary to ensure that Roche has uninterrupted access to clinical
supply, under terms no less favorable than in existence as of the Execution
Date, prior to and during any manufacturing transition.

Stressgen shall use Diligent Efforts to provide, and shall, to the
extent within its control, cause [* * *] to Roche or its designee, the
Manufacturing Transfer Package [* * *]. 
Stressgen shall cooperate with Roche at Roche’s cost for reasonable
out-of-pocket expenses incurred by Stressgen with respect to implementing the
necessary transfer of manufacturing know how to Roche.

9.3          Clinical Supplies of Process A Target
Product for Use in RRP and the Other Stressgen Development Activities.  To the extent it has not already done so
as of the Execution Date, Stressgen shall be responsible for obtaining all of
its requirements for clinical supply of Process A Target Product, and placebo,
in finished form to be used in the Territory during the Term, either by itself,
or through a Third Party, for RRP as well as the Other Stressgen Development
Activities. Costs incurred by Stressgen for clinical supply of Process A Target
Product and placebo for use in RRP clinical trials shall be included within
Stressgen RRP Development Costs.

9.4          Clinical Supplies of Process B Target Product for Use in RRP and the
Other Stressgen Development Activities.

(a)           Roche shall use Diligent Efforts to supply, either by itself
or through a Third Party, Stressgen all Process B Target Product and placebo
requested by Stressgen for Development Activities related to RRP and Other
Stressgen Development Activities, in the form and formulation specified by
Stressgen.  Notwithstanding the above,
Roche shall have no obligation to supply to Stressgen (i) [* * *], (ii) a
number of units of placebo in excess of the units of Target Product supplied by
Roche, or (iii) any form or formulation of Process B Target Product that Roche
is not otherwise manufacturing for the Roche Development Activities.  In the event Stressgen requests Target
Product in a form or formulation that Roche is not otherwise manufacturing for

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

33

 

the Roche
Development Activities, Roche shall be obligated to supply to Stressgen only [*
* *].

(b)           Promptly after the Effective Date, Roche and Stressgen
shall agree in writing on (i) the amount of Target Product and placebo to be
supplied by Roche to Stressgen for the first year after the Effective Date,
which amounts Stressgen shall receive as soon as practicable but in any event
not later than a mutually agreed upon period after the Effective Date, and (ii)
procedures for Stressgen submitting its requirements and Roche supplying
Process B Target Product and placebo thereafter.  Such procedures shall include Stressgen providing (a) annual
non-binding [* * *] forecasts of its requirements and (b) firm purchase
commitments no less than [* * *] prior to the time the order must be delivered
to Stressgen by or on behalf of Roche.

(c)           Amounts paid by Stressgen to Roche for clinical supply
of Process B Target Product and placebo for use in RRP clinical trials shall be
included within Stressgen RRP Development Costs.

9.5          Commercial Supply.

(a)           Roche’s Rights to Supply.  Roche shall be solely and exclusively
responsible at its own expense for the manufacture and supply of Target Product
for sale in the Territory, either by itself or through Third Parties.  Roche agrees and acknowledges that its
rights to supply Target Product for sale in the U.S. are subject to Section 2.2
of the MIT Agreement.  If Roche decides
to engage one or more secondary suppliers to ensure there are multiple, stable
sources of Target Product for sale in the Territory, then Roche shall notify
Stressgen in writing and Stressgen shall have a right to present itself as a
potential secondary source of commercial supply of Target Product.  In such event, the decision of whether to
use Stressgen as a secondary source of supply shall rest with the Steering
Committee.

(b)           Manufacturing License Grant.  Subject to the terms of this Agreement,
and in order to effectuate Roche’s grant of rights to be the primary supplier
of Target Product for commercial sale in the Territory (a) [* * *]; and
(b) [* * *].  Roche

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

34

 

agrees and
understands that the license set forth above, to the extent it contains within
it a sublicense under the MIT Agreement, shall terminate as provided in Article
16, but in no event shall the term thereof extend beyond the term of the MIT
Agreement.  Such acknowledgement is
subject to the terms and conditions of this Agreement, in particular Articles
15 and 17.  The rights and licenses
granted to Roche under this Section shall include the right to grant [* * *] to
its Affiliates and Third Parties under such rights and licenses, in whole or in
part.  If Roche grants such a [* * *], Roche
shall ensure that all of the applicable terms and conditions of this Agreement
shall apply to the Affiliate or Third Party [* * *] to the same extent as they
apply to Roche for all purposes.  Roche
assumes full responsibility for the performance of all obligations so imposed
on such Affiliate or Third Party [* * *] and will itself account to Stressgen
for all payments due under this Agreement by reason of such [* * *].  Any [* * *] granted under this Section 9.5(b)
by Roche shall terminate upon the early termination of this Agreement, and will
revert to non-exclusive upon expiration of the Term.

The foregoing rights are subject to the limited retained rights of
Stressgen to make, or have made, Process A Target Product for its use in
clinical trials as provided in Section 9.3.

9.6          Packaging. 
To the extent in compliance with legal and commercial requirements on a
country-by-country basis, Roche agrees that the packaging of all Target
Products sold by Roche, its Affiliates or sublicensees shall identify Stressgen
as licensor in a manner approved in advance in writing by Stressgen.  From time to time, Stressgen shall provide
to Roche in writing the form and manner in which Stressgen approves of the use
of Stressgen’s name in connection with, or in relation to any such packaging.

ARTICLE
10

COMMERCIALIZATION

10.1        Responsibilities of Roche. 
Except as expressly set forth in this Article 10, Roche, at its own
expense, shall have sole responsibility and decision making authority for the
marketing, promotion, sale and distribution of Target Product in the

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

35

 

 Territory, including post-registration
clinical and marketing studies which are not conducted in order to obtain, expand
and/or maintain Regulatory Approval of a Target Product in the Territory.

10.2        Diligent Efforts by Roche; Reporting. 
During the Term, upon written request of Stressgen not to exceed once
per year, Roche will fully inform Stressgen regarding the commercialization of
Target Products in the Territory by Roche, its Affiliates and
sublicensees.  Roche, directly or
through its Affiliates and/or sublicensees, shall use Diligent Efforts to
pursue the commercialization of Target Products throughout the Territory.  If Stressgen believes in good faith that
Roche has failed to utilize Diligent Efforts with respect to commercialization
of Target Product, then Stressgen may give Roche written notice of such alleged
failure, identifying the countries at issue and specific detailed reasons of
such allegation.  Stressgen recognizes
that Roche does seek to market its products in all countries of the Territory,
and may not seek to commercialize Target Product in every country of the
Territory.  Within [* * *] days following
Roche’s receipt of any such notice from Stressgen, Roche shall have the right
to  provide Stressgen with a written
response specifying, in reasonable detail, how it is using or has begun to use
such Diligent Efforts.

If Roche does not provide
a written response which demonstrates, in reasonable detail, how it has
complied with its obligation to use Diligent Efforts within [* * *] days after
the receipt of such notice, then, effective upon the expiration of such [* * *]
day period, Stressgen shall have the right to terminate this Agreement for the
country(ies) at issue upon written notice to Roche; provided, however, that in
the event of a dispute between the Parties with respect to whether Roche has
failed to utilize Diligent Efforts with respect to commercialization of Target
Product in a country, then such dispute shall be resolved in accordance with
Article 18.  The consequences of any
termination pursuant to this Article 10 shall be as set forth in Section 16.4.

10.3        Co-Promotion by Stressgen. 
Stressgen shall have the right to co-promote Target Products in the U.S.
(to be more fully described in a written co-promotion plan to be agreed upon by
the Parties reasonably in advance of the

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

36

 

anticipated launch
of the first Target Product in the U.S.) as follows: (a) detailing of Target
Products to [* * *] using approximately  
[* * *] Stressgen sales representative FTEs; and (b) if Roche wishes to
seek a partner to detail Target Product to [* * *], then detailing of Target
Products to [* * *] using approximately [* * *] Stressgen sales representative
FTEs.  Stressgen shall be responsible
for the training and compensation of all such Stressgen FTEs devoted to promoting
Target Products, and Roche shall [* * *].

10.4        Roche Competitive Products. 
In the event that Roche, at any time during the term of this Agreement,
acquires rights, whether by reason of its own effort or under license from a
Third Party, to a Roche Competitive Product (as defined below), then such Roche
Competitive Product shall be [* * *]. 
As used in this Section 10.4, “Roche Competitive Product” shall mean
(a)  [* * *] whether or not such product is owned by or licensed to Roche
or (b)  [* * *].  In the event
Roche terminates this Agreement pursuant to Section 16.4 and by the end of [* *
*] following the effective date of such termination, any such Roche Competitive
Product is [* * *]: (i) [* * *]; (ii) [* * *]; and (iii) [* * *].  After the [* * *] of such effective date of
termination, Roche would no longer be obligated to [* * *] under this Section
10.4.

ARTICLE 11

TRADEMARKS

11.1        Trademarks. 
Roche shall own worldwide all trademarks on and in connection with
Target Products (excluding trade names of Stressgen used on and in connection
with Target Products), and shall, at its cost, be responsible for procurement,
maintenance and enforcement of all worldwide trademarks registration on and in
connection with Target Products.

ARTICLE
12

OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS

                12.1        Ownership of Intellectual Property. 
As between the Parties, Stressgen shall own all Stressgen Inventions,
Roche shall own all Roche Inventions,

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

 

37

 

 

 and Stressgen
and Roche shall jointly own all Joint Inventions. Except to the extent any
Joint Invention is exclusively licensed by one Party to the other Party
hereunder, each Party shall have the right to practice Joint Inventions, and to
grant licenses to Affiliates and Third Parties under Patents claiming Joint
Inventions, without the other party’s consent and without any duty to account
to the other Party with respect thereto. 
Each Party shall require all of its employees to assign all inventions
related to Target Products made by them to such Party.

 

12.2        Patent Prosecution and Maintenance.

(a)           Base Patents.  To the extent any Base Patents or other
Stressgen Patent Rights are licensed to Stressgen under the MIT Agreement
(collectively, “MIT Patents”), the provisions of this Section 12.2 shall be
subject to all applicable terms and conditions of the MIT Agreement, and this
Section 12.2 shall in no event be construed to confer on Roche any right with
respect to the Handling (as defined below) of any such MIT Patents.  Stressgen shall prepare, file, prosecute
(including interference and opposition proceedings) and maintain (including
interferences, re-examination and opposition proceedings) (collectively, “Handle”)
the Base Patents (excluding any MIT Patents), at Stressgen’s expense.

Stressgen shall use
reasonable efforts to consult with Roche as to the Handling of all Base Patents
in sufficient time (for example 30 days for instances where actions are due
within 3 months of a communication from a Patent Office) before any action is
due to allow Roche to provide comments thereon, which comments Stressgen must
reasonably consider if provided to Stressgen at least thirty (30) days before
such action is due.  Should Stressgen decide
that it does not desire to Handle a Target Product-Specific Base Patent in a
given country, it shall advise Roche thereof no less than sixty (60) days prior
to the date when the Target Product-Specific Base Patent would become abandoned
in such country.  At the written request
of Roche, Stressgen shall then, at no cost to Stressgen, assign to Roche such
Target Product-Specific Base Patent in such country, and Roche may thereafter
Handle the same in Roche’s name, at Roche’s own cost, to the extent that Roche
desires to do so.  For purposes of
clarification, as between the Parties Stressgen shall have sole control over,
and decision-making

 

 

38

 

authority with
respect to, the Handling of Base Patents to the extent the scope of claims
relates to subject matter other than Target Product.

(b)           Stressgen Inventions.

(i)            Priority Applications.  Stressgen
promptly will notify Roche in writing (“Patent Notice”) of any Stressgen Inventions
on which Stressgen intends to file a patent application.

Within sixty (60) days
after receipt of the Patent Notice, Roche will notify Stressgen in writing if
Roche has an interest in having a priority patent application filed.  If Roche timely notifies Stressgen in writing
of interest in having a priority application filed (“Stressgen Invention Priority Application”),
then:

(A)          Roche will reimburse Stressgen for fifty percent (50%)
of the reasonable and documented external costs for preparing, filing and
prosecuting the Stressgen Invention Priority Application and maintaining any
resulting Stressgen Patents within thirty (30) days of invoice by Stressgen;

(B)          Stressgen promptly will prepare and send to Roche a
draft of the Stressgen Invention Priority Application for Roche’s comment and
approval; and

(C)          Roche shall confirm receipt of the draft Stressgen
Invention Priority Application and provide its comments on the draft to
Stressgen within thirty (30) days after receipt thereof (“Comment Period”).

After reasonably
considering Roche’s comments, Stressgen shall file the Stressgen Invention
Priority Application.  If Roche fails to
provide comments on a draft within the Comment Period, Stressgen shall be free
to file the Application at the end of the Comment Period or later.

If Roche does not timely
notify Stressgen in writing of interest in a Stressgen Invention Priority
Application, Stressgen shall be free to file the application at its sole
expense and discretion.

 

 

39

 

 

(ii)           Corresponding Application in Foreign
Countries.  Within six (6) months after the filing of a
Stressgen Invention Priority Application, Stressgen shall provide Roche a
written list of countries (“Country List”) in which Stressgen intends
to file patent applications that claim priority from the given Stressgen
Invention Priority Application.  Roche,
as promptly as practicable, shall notify Stressgen in writing of those
countries on the Country List and any additional countries (“Additional
Countries”) where Roche requests that patent applications be
filed.  In turn, Stressgen promptly
shall notify Roche if it agrees with the filing of applications in such
Additional Countries selected by Roche.

Stressgen shall file
patent applications at least in those countries where Roche and Stressgen agree
to the filing of patent applications (“Mutually Agreed to Countries”) as well as
in Additional Countries selected by Roche that are not within the Mutually
Agreed to Countries.  Stressgen shall
have the option of filing an international application designating at least the
Mutually Agreed to Countries, to be followed by national filings in the desired
countries.

Stressgen shall be
responsible for the filing and prosecution of the patent applications and the
maintenance of the granted patents as to the Mutually Agreed to Countries.  As to the Mutually Agreed to Countries,
Roche and Stressgen each will pay fifty percent (50%) of the reasonable
external costs relating to the preparation, filing and prosecution of the
patent applications and the maintenance of the granted patents.

As to those countries
where Roche or Stressgen do not agree to the filing of patent applications, the
Party requesting the filing in said country shall be responsible for all costs
relating to the filing and prosecution of the patent applications and the
maintenance of the granted patents in said countries.

Should Roche not respond
to Stressgen within thirty (30) days after the date Stressgen provides the
Country List, then Stressgen shall be free to initiate patent filings, at
Stressgen’s sole expense and discretion, in the countries Stressgen has
selected or still selects.

 

 

40

 

 

Stressgen’s failure to
notify Roche to the contrary within thirty (30) days after the date upon which
Roche notifies Stressgen of the Additional Countries will be deemed an
agreement on the part of Stressgen to file patent applications in all such
Additional Countries and to pay fifty percent (50%) of the reasonable external
costs associated with such filings.

(iii)         Withdrawal of Funding/Lack of Further
Interest.  If, in a country, at any time, Roche decides
not to continue funding the prosecution of a patent application or maintenance
of a patent under Subparagraphs (i) or (ii) above, Roche shall notify
Stressgen in writing (“Withdrawal Notice”), and Roche shall be
relieved from paying any further expenses with regard to the patent filing in
the country.  After receiving the
Withdrawal Notice, Stressgen may but is not obligated, at its sole expense and
discretion, to continue to prosecute and maintain the patent filing in the
country.

If, in a country, at any
time, Stressgen decides not to continue the prosecution of a patent application
or maintenance of a patent under Subparagraphs (i) or (ii) above, that is
Target Product-Specific, and such patent application or patent is not one as to
which Roche has already sent a Withdrawal Notice, then Stressgen shall notify
Roche in writing no less than sixty (60) days prior to the date when the patent
application or patent would become abandoned in such country.  At Roche’s written request and no cost to
Stressgen, Stressgen shall then assign to Roche such patent application or
patent in such country, and Roche may thereafter continue to prosecute and maintain
the patent filing in the country, at Roche’s own cost and in Roche’s name, to
the extent Roche desires to do so.

(iv)          Copies of Communications with Patent
Offices.  For the Mutually Agreed to
Countries and Additional Countries, Stressgen shall consult with Roche as to
the prosecution and maintenance of all patent applications and patents claiming
Stressgen Inventions in sufficient time (for example thirty (30) days for
instances where actions are due within three (3) months of a communication from
a Patent Office) before any action is due to allow Roche to provide comments
thereon, which comments Stressgen must reasonably consider.

 

 

 

41

 

 

(c)           Joint Inventions.

(i)            Priority Applications.  For
Joint Inventions, the Parties shall agree which Party shall have the right to
prepare and file a priority patent application (“Priority Filing Party”). If
both Parties wish to have a priority application filed (“Joint Invention Priority Application”),
then:

(A)          Each Party will pay one half (1/2) of the reasonable
external costs for preparing, filing and prosecuting the Joint Invention
Priority Application and maintaining any resulting patents;

(B)          The Priority Filing Party promptly will prepare and
send to the other Party a draft of the Joint Invention Priority Application for
the other Party’s comment and approval; and

(C)          The other Party shall confirm receipt of the draft
Joint Invention Priority Application and provide its comments to the Priority
Filing Party on the draft within thirty (30) days after receipt thereof (“Comment
Period”).

After incorporating the
other Party’s reasonable comments, the Priority Filing Party shall file the
Joint Invention Priority Application. 
If the other Party fails to provide comments on a draft within the
Comment Period, the Priority Filing Party shall be free to file the Application
at the end of the Comment Period or later.

If a Party does not have
an interest in having a Joint Invention Priority Application filed, the other
Party shall be free to file the application at its sole expense and discretion.

(ii)           Corresponding Application in Foreign
Countries.  Within six (6) months after the filing of an
Joint Invention Priority Application, the Priority Filing Party shall provide
the other Party a written list of countries (“Country List”) in which the
Priority Filing Party intends to file patent applications that claim priority
from the given Joint Invention Priority Application.  The other Party, as promptly as practicable, shall notify the
Priority Filing Party in writing of those countries on the Country List and

 

 

 

42

 

 

 any additional
countries (“Additional Countries”) where the other Party requests that
patent applications be filed.  In turn,
the Priority Filing Party promptly shall notify the other Party if it agrees
with the filing of applications in such Additional Countries selected by the
other Party.

The Priority Filing Party
shall file patent applications at least in those countries where the Parties
agree to the filing of patent applications (“Mutually Agreed to Countries”).

The Priority Filing Party
shall be responsible for the filing and prosecution of the patent applications
and the maintenance of the granted patents as to the Mutually Agreed to
Countries.  As to the Mutually Agreed to
Countries, each Party will pay one-half of the reasonable external costs
relating to the preparation, filing and prosecution of the patent applications
and the maintenance of the granted patents.

As to those countries
where Roche or Stressgen do not agree to the filing of patent applications, the
Party requesting the filing in said country shall have right, but not the
obligation, in its name to file and prosecute the patent applications and maintain
the granted patents in said countries to the extent it desires to do so, and
shall be responsible for all costs relating to the filing and prosecution of
the patent applications and the maintenance of the granted patents in said
countries.

Should the other Party
not respond to the Priority Filing Party within thirty (30) days after the date
the Priority Filing Party provides the Country List, then the Priority Filing
Party shall be free to initiate patent filings, at its sole expense and
discretion, in the countries it has selected or still selects.

The Priority Filing
Party’s failure to notify the other Party to the contrary within thirty (30)
days after the date upon which the other Party notifies the Priority Filing
Party of the Additional Countries will be an agreement of the Priority Filing
Party to file patent applications in all such Additional Countries and to pay
one half of the reasonable external costs associated with such filings.

 

 

43

 

 

(iii)         Withdrawal of Funding/Lack of Further
Interest.  If, in a country, at any time, a
Party decides not to continue funding the prosecution of a patent application
or maintenance of a patent under Subparagraphs (i) or (ii) above or not to
continue the prosecution of a patent application or maintenance of a patent
under Subparagraphs (i) or (ii) above, then such Party shall notify the other
Party in writing no less than sixty (60) days prior to the date when the patent
application or patent would become abandoned in such country (“Withdrawal
Notice”), and such Party shall be relieved from paying any further
expenses with regard to the patent filing in the country.  After receiving the Withdrawal Notice, the
other Party may but is not obligated, at its sole expense and in its own name,
to continue to prosecute and maintain the patent filing in the country to the
extent it desires to do so.

(iv)          Copies of Communications with Patent
Offices.  For the Mutually Agreed to
Countries, the Priority Filing Party shall consult with the other Party as to
the prosecution and maintenance of all patent applications and patents claiming
Joint Inventions in sufficient time (for example thirty (30) days for instances
where actions are due within three (3) months of a communication from a Patent
Office) before any action is due to allow the other Party to provide comments
thereon, which comments the Priority Filing Party must reasonably consider.

(d)           Cooperation.  The
Parties agree to cooperate in the preparation, prosecution and maintenance of
all patent applications filed under Sections 12.2(b) and (c), including
obtaining and executing necessary powers of attorney and assignments by the
named inventors, providing relevant technical reports to the filing Party
concerning the invention disclosed in such patent application, obtaining
execution of such other documents which shall be needed in the filing and
prosecution of such patent applications, and, as requested, updating each other
regarding the status of such patent applications.

12.3        Infringement. 
Each Party shall promptly provide written notice to the other Party
during the Term of any known infringement or suspected infringement by a Third
Party of any Stressgen Patent Right.

 

 

44

 

 

Roche shall have the
first right to bring and control any action or proceeding with respect to
infringement of any Target Product-Specific Base Patent at its own expense and
by counsel of its own choice, and Stressgen shall have the right, at its own
expense, to be represented in any such action by counsel of its own
choice.  If Roche fails to bring any
such action or proceeding with respect to infringement of any such Target
Product-Specific Base Patent within (a) sixty (60) days following the notice of
alleged infringement or (b) ten (10) days before the time limit, if any, set
forth in the appropriate laws and regulations for the filing of such actions,
whichever comes first, Stressgen shall have the right to bring and control any
such action at its own expense and by counsel of its own choice, and Roche
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice.

Subject in any event to
all applicable provisions of the MIT Agreement, as between the Parties,
Stressgen shall have the sole right to bring and control any action or
proceeding with respect to infringement of any Stressgen Patent Right that is
not Target Product-Specific Base Patent at its own expense and by counsel of
its own choice, and, with respect to infringement of any such Stressgen Patent
Right that is likely to have a material adverse effect on any Target Product
being developed or commercialized by Roche, Roche shall have the right, at its
own expense, to be represented in any such action by counsel of its own choice.

A Party that elects to
bring and control an infringement action pursuant to this Section 12.3 shall
provide prompt written notice to the other Party of any such suit commenced or
action taken by such Party.

Upon written request, the
Party bringing suit or taking action (“Initiating Party”) shall keep the other
Party informed of the status of any such suit or action and shall provide the
other Party with copies of all substantive documents communications filed in
such suit or action.  The Initiating
Party shall have the sole and exclusive right to select counsel for any such
suit or action.

The Initiating Party
shall, except as provided below, pay all expenses of the suit or action,
including, without limitation, the Initiating Party’s attorneys’ fees and court

 

 

45

 

 

costs.  After deducting the Parties’ attorneys fees
and court costs in connection with any such suit or action, any damages,
settlement fees or other consideration received as a result of such suit or
action shall belong to the Initiating Party, except to the extent such damages,
settlement fees or other consideration are attributable to lost profits with
respect to Target Products in the Territory, which shall form part of the Net
Sales for determining amounts due to Stressgen in any calendar year.

If the Initiating Party
believes it reasonably necessary, upon written request to the other Party, the
other Party shall join as a party to the suit or action but shall be under no
obligation to participate except to the extent that such participation is
required as the result of its being a named party to the suit or action.  At the Initiating Party’s written request,
the other Party shall offer reasonable assistance to the Initiating Party at no
charge to the Initiating Party except for reimbursement of reasonable
out-of-pocket expenses incurred by the other Party in rendering such
assistance.  The other Party shall have
the right to participate and have its own representation in any such suit or
action at its own expense.

The Initiating Party
shall have the right to control settlement; provided, however, that no settlement
shall be entered into without the written consent of the other Party, not to be
unreasonably withheld.

12.4        Patent Notices. 
All notices provided under this Article 12 to Roche shall be given to:

F.Hoffmann-La
Roche Ltd

Grenzacherstrasse
124

CH-4070 Basel,
Switzerland

Attn: Head, Patent Law

with copies of all
notices relating to U.S. cases to:

Hoffmann-La Roche
Inc.

340 Kingsland
Street

Nutley, New
Jersey  07110

Attn: Chief Patent Counsel.

All notices
provided under this Article 12 to Stressgen shall be given to:

 

 

 

46

 

 

Stressgen
Biotechnologies, Inc.

10241 Wateridge
Circle Drive

Suite C200

San Diego,
California  92121

USA

Attn: General Counsel

with copies to:

Stressgen
Biotechnologies Corporation

350-4243 Glanford
Avenue

Victoria, B.C. V87
4B9

Canada

Attn: Executive
Director, Intellectual Property & Licensing

 

ARTICLE 13

CONFIDENTIAL INFORMATION

13.1        Non-Disclosure and Non-Use.  In carrying out rights and obligations
under this Agreement, the Parties will share proprietary information (“Confidential
Information”) with each other. 
A Party receiving Confidential Information under this Agreement (“Recipient”)
from the other disclosing Party (“Discloser”) shall maintain such
Confidential Information as follows:

During the Term, the
Recipient receives a given item of Confidential Information, the Recipient agrees:

(a)           not to use such Confidential Information for any
purpose other than in connection with the purpose of carrying out its rights
and obligation under this Agreement;

(b)           to treat such Confidential Information as it would its
own information of the same nature and importance, and in any event, to use no
less than a reasonable degree to care to protect the proprietary nature of such
Confidential Information; and

(c)           to take all reasonable precautions to prevent the
disclosure of such Confidential Information to any non-Affiliate Third Party
without the prior written consent of the Discloser.

 

 

47

 

 

13.2        Exceptions.  A Recipient shall be relieved of any and
all obligations under Section 13.1 regarding Confidential Information which:

(a)           was known to the Recipient or its Affiliate prior to
receipt hereunder; or

(b)            as demonstrated by the Recipient by competent written
proof, is independently generated by the Recipient or its Affiliate by persons
who have not had access to or knowledge of the Confidential Information
disclosed hereunder; or

(c)           at the time of disclosure by the Discloser to the
Recipient, was generally available to the public, or which after disclosure
hereunder becomes generally available to the public through no fault
attributable to the Recipient; or

(d)           is hereafter made available to the Recipient or its
Affiliate for use and unrestricted disclosure by the Recipient from any Third
Party having a right to do so.

13.3        Authorized Disclosure.  Nothing in this Agreement shall prohibit
disclosure by a Party of Confidential Information to its consultants,
sublicensees, advisors, clinical investigators and contract manufacturer, if
any, but only on a need to know basis for purposes provided for in this
Agreement, provided such disclosure occurs pursuant to a written
confidentiality agreement containing provisions substantially as protective as
those of this Article.

The restrictions set
forth in this Article shall not prevent Roche from disclosing any Confidential
Information specifically related to Target Product to the extent

 

 

48

 

 

reasonably
necessary to promote the marketing of Target Product in a country upon or after
imminent Regulatory Approval of Target Product in the country.

The restrictions set
forth in this Article shall not prevent disclosure to the extent required
pursuant to a judicial or governmental order, provided that the Recipient gives
the Discloser sufficient notice to permit the Discloser to seek a protective
order or other similar order with respect to such Confidential Information.

This Agreement supercedes
the Confidentiality Agreement between Roche and SBC dated February 13,
2001.  All information exchanged
thereunder shall be deemed Confidential Information under this Agreement and
shall be subject to this Article 13.

13.4        Survival.  This
Article 13 shall survive any termination or expiration of this Agreement for a
period of 

[* * *] years.

ARTICLE 14

PUBLICATION AND PRESS RELEASE

14.1        Publications.

(a)           Each Party agrees that it shall not publish or present
the results of non-clinical studies or clinical trials related to Target
Product without the opportunity for prior review by the other Party.  If a Party (“Publishing Party”) wishes to
publish or present the results of non-clinical studies or clinical trials
related to Target Product, then it shall provide to the other Party (“Non-Publishing
Party”) the opportunity to review any of the Publishing Party’s
proposed abstracts, manuscripts or presentations (including information to be
presented verbally) which relate to Target Product at least ninety (90) days
prior to their intended submission for publication or presentation as the case
may be.  The Publishing Party agrees,
upon written request from the Non-Publishing Party, not to submit such abstract
or manuscript for publication or to make such presentation until the
Non-Publishing Party is given up to thirty (30) days from the date of such
written request to seek appropriate patent protection for any material in such
publication or presentation which it reasonably believes is patentable. The
Non-Publishing Party also shall have the right to require deletion of its
Confidential

 

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

49

 

 

 

Information that may be in any such proposed
publication, prior to such publication. 
In the event that either Party submits any manuscript or other
publication relating to any Target Product, it shall consider and acknowledge
the contributions of the other Party, including, as appropriate, co-authorship.

 

(b)           Notwithstanding the above, Roche shall have the right
to publish or present the results of non-clinical studies or clinical trials
related to Target Product without prior review by Stressgen to the extent
reasonably necessary to promote the use and sale of Target Product in a country
upon or after Regulatory Approval of Target Product in the country.

(c)           Notwithstanding the above, Roche acknowledges and understands
that nothing in this Agreement shall be construed as limiting in any way the
rights of NCI or the US Government or its designee to publish any results of
the clinical trials undertaken by the NCI pursuant to the NCI Agreements.

14.2        Press Release; Public Disclosure of
Agreement.  The Parties shall issue a mutually agreed
upon joint press release promptly following the Execution Date.  Stressgen and Roche will jointly discuss and
agree in writing on any statement to the public regarding this Agreement or any
aspect of this Agreement, subject in each case to disclosure otherwise required
by law or regulation as determined in good faith by each Party.  When a Party elects to make any such
statement it will give the other Party at least five (5) day’s notice, unless
disclosure is required by law, or any listing or trading agreement concerning
its publicly traded securities, in a shorter period of time, to the other Party
to review and comment on such statement. 
Notwithstanding the foregoing, either Party shall have the right to
publicly disclose information regarding this Agreement or the Parties’
activities hereunder, to the extent such information has already been made
publicly available in a manner consistent with this Section 14.2.

 

ARTICLE
15

REPRESENTATIONS, WARRANTIES AND COVENANTS

15.1        Mutual Representations and Warranties. 
Each Party hereby represents and warrants, that, as of the Execution
Date:

 

50

 

 

(a)           Such Party has the full right and authority to enter
into this Agreement, and that it is not aware of any impediment that would
inhibit its ability to perform its obligations under this Agreement; and

(b)           Such Party has disclosed to the other Party (i) the
results of all preclinical testing and human clinical testing of Target Product
in its possession or control, to the extent same has been requested by the
other Party; and (ii) all information in its possession or control concerning
side effects, injury, toxicity or sensitivity reaction and incidents or
severity thereof with respect to Target Product.

15.2        Stressgen Representations and Warranties. 
Stressgen warrants and represents that:

(a)           During the course of negotiation of this Agreement
prior to the Execution Date, Roche, or representatives of Roche, have had the
opportunity to ask questions of and receive answers from representatives of
Stressgen concerning, and to obtain information, documents, records and books
relative to, Stressgen, its business, HspE7 and Target Products, and Stressgen
represents and warrants that it did not knowingly withhold any material
information from Roche in response to Roche’s inquiries or otherwise in
connection with the subject matter of this Agreement.

(b)           To the best of its knowledge as of the Execution Date,
Stressgen has (i) no knowledge of any patent or patent application owned by or
licensed to any Third Party that claims the making, using, offering for sale,
selling or importing of HspE7, except as disclosed to Roche in response to
Roche’s inquiries and (ii) not received written notice that the manufacture,
use, sale, offer for sale or import of Target Products in the Territory
infringes or may infringe any patent or patent application owned by or licensed
to any Third Party, except as disclosed to Roche in response to Roche’s
inquiries.  To the best of its knowledge
as of the Execution Date, Stressgen is not in possession of information which
it reasonably believes could render invalid and/or unenforceable any claims
that are in any of any Base Patent.

 

 

51

 

 

(c)           To the best of its knowledge, Stressgen and/or SBC, as
the case may be, has the right to grant Roche the rights and licenses described
in this Agreement.

15.3        Roche Representations and Warranties.  Roche represents that during the course of this
transaction and prior to the Execution Date, Roche has had an opportunity to
ask questions of, and to receive answers from, Stressgen and its
representatives, with respect to Stressgen, its business, HspE7 and Target
Products.

15.4        Stressgen Covenants. 
Stressgen covenants that it shall promptly notify Roche of any changes
or modifications to the MIT Agreement and shall not take, cause or approve any
action that might adversely affect Roche’s rights as a sublicensee under the
MIT Agreement without prior written consent of Roche, which consent Roche may
withhold for any reason.

15.5        No Other Representations or Warranties. 
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE FOREGOING
REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF, AND EACH PARTY EXPRESSLY
DISCLAIMS, ANY AND ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF DESIGN, MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE
PRACTICES.  IN NO EVENT SHALL EITHER
PARTY BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE
OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT; provided, however, that the
foregoing shall not be construed to limit either Party’s indemnification
obligations under Article 17.

ARTICLE
16

TERM AND TERMINATION

16.1        Conditions
Subsequent.

 

52

 

 

(a)           The effectiveness of this Agreement and the
transaction contemplated hereunder and under the Equity Agreement shall be
subject to and shall be contingent upon the satisfaction of the following
conditions subsequent to the execution hereof by December 31, 2002 (“Conditions Subsequent”):

(i)            the earlier to occur of (A) approval of the
transaction by the Federal Trade Commission or the appropriate United States
anti-trust authorities or (B) the expiration or termination of all
applicable waiting periods, requests for information (and any extensions
thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”); and

(ii)           the payment of Five Million dollars ($5,000,000) to
Stressgen or its Affiliate under the Equity Agreement and delivery to Roche or
its Affiliate of the Stressgen common stock purchased under the Equity
Agreement for such payment.

(b)           Subject to the terms and conditions of this Agreement,
each Party shall use all reasonable efforts to take, or cause to be taken, all
reasonable actions and to do, or cause to be done, all things necessary and
appropriate to satisfy each of the Conditions Subsequent and to consummate the
transactions contemplated by this Agreement in accordance with the terms
hereof.

(c)           Each Party shall cooperate with the other Party in the
preparation, execution and filing of all documents that are required or
permitted to be filed on or before the Effective Date for the purpose of
consummating this transaction, including, without limitation, filings pursuant
to the HSR Act.  Each Party shall bear
its own costs with respect to preparing, executing and filing such documents.

16.2        Term.  The Term of this Agreement shall
commence upon the Effective Date. 
Unless this Agreement is terminated sooner as provided in this Article,
this Agreement shall continue in full force and effect until the end of the
Term, at which time all the rights and licenses granted to Roche by Stressgen
under this Agreement for the Target Product shall automatically become non-exclusive,
irrevocable and fully-paid.

 

 

53

 

 

16.3        Breach.  A Party
(“non-breaching party”) shall have the right, in addition to any other rights
and remedies, to terminate this Agreement in the event the other Party
(“breaching party”) is in breach of any of its material obligations under this
Agreement.  The non-breaching party
shall provide written notice to the breaching party, which notice shall
identify the breach and the countries in which the non-breaching party intends
to have this Agreement terminate.  The
breaching party shall have a period of sixty (60) days after such written
notice is provided to cure such breach. 
If such breach is not cured within the relevant period, the
non-breaching Party shall have the right to terminate this Agreement.

The waiver by either
Party of any breach of any term or condition of this Agreement shall not be
deemed a waiver as to any subsequent or similar breach.

16.4        Termination by Roche Without Cause. 
At any time during the Term, Roche shall have the right to terminate
this Agreement in its entirety, or on a country-by-country and Target
Product-by-Target Product basis, at any time by providing [* * *] prior written
notice to Stressgen identifying, as applicable, the Target Product and
countries in which Roche intends to terminate this Agreement.  The effective date of such termination shall
be [* * *] after the date Roche provides such written notice; provided,
however, that Roche shall have no obligation to pay any Development
Event Payments pursuant to Section 3.3 that may be triggered by events
occurring during such [* * *] period prior to the effective date of such
termination, where such termination is of the Agreement in its entirety.  In the event of such termination, Roche
shall, however, continue to be obligated to during the termination notice
period to perform all of its other obligations hereunder, including its
obligation to pay all Development Costs or reimburse Stressgen for same.

16.5        Consequences of Termination. 
Upon (a) any termination of this Agreement in its entirety pursuant to
this Article 16, (b) termination of this Agreement by Roche of this Agreement
in its entirety or in a country or in respect of a Target Product pursuant to
Section 16.3, or (c) termination of this Agreement by Stressgen in a country
pursuant to Article 10, all rights and licenses granted by Stressgen to Roche
under this

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

54

 

 

Agreement (or, as
applicable, in the country or with respect to that Target Product) shall
terminate on the effective date of termination.  In the event of any such termination, the following shall apply:

(a)           Roche shall, upon Stressgen’s written request, assign
and transfer to Stressgen, [* * *]. 
Stressgen shall, upon such transfer, have the right to disclose such [ *
* *].

(b)           In addition, [* * *].

(c)           Roche shall supply, or cause to be supplied, to
Stressgen, upon Stressgen’s written request,

[* * *].

(d)           Roche shall agree to take such actions and execute
such instruments, agreements and documents as are necessary to affect the
foregoing.

16.6        Termination
for Failure to Satisfy Conditions Subsequent. 
Either Party may terminate this Agreement in its entirety, upon ten (10)
days’ prior written notice to the other Party if both of the Conditions
Subsequent under Section 16.1 have not been fulfilled by December 31, 2002, in
which case upon termination there shall be no liability or obligations on the
part of Stressgen or Roche or their respective Affiliates, officers, directors
or shareholders except that Article 13 shall survive such termination.  Within thirty (30) days of any such
termination, Stressgen shall pay to Roche any amounts received from Roche as of
such date pursuant to this Agreement, unless otherwise agreed upon in writing
by the Parties.

                16.7        Accrued Rights; Surviving Rights and Obligations. 
Subject to Section 16.7, expiration or termination of this Agreement by
a Party, for any reason, will not relieve either Party of any obligation
accruing prior to such expiration or termination.  Except as set forth below or as expressly set forth elsewhere in
this Agreement, the obligations and rights of the Parties under the following
provisions of this Agreement shall survive expiration or termination of this
Agreement to the extent that the survival of such rights or obligations are
necessary to permit their complete fulfillment or discharge:

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

 

 

55

 

 

 

Section 5.5, Article 11, Section 12.1, 12.2 (c),
Article 13, Article 16, Article 17,  and
Article 18.

 

ARTICLE
17

INDEMNIFICATION

17.1        Indemnification by Stressgen. 
Unless otherwise provided herein, Stressgen agrees to indemnify, hold
harmless and defend Roche and its directors, officers, employees and agents
from and against any and all suits, claims, actions, demands, liabilities,
expenses and/or loss, cost of defense (including without limitation attorneys’
fees, court costs, witness fees, damages, judgments, fines and amounts paid in
settlement) (“Losses”) and any other amounts Roche becomes legally obligated to
pay to a Third Party, including MIT, because of any claim or claims against it
to the extent that such claim or claims arise out of (a) a breach of a
representation or warranty or covenant by Stressgen under Article 15 or (b) the
use, development, handling or commercialization of Target Product by or on
behalf of Stressgen, its Affiliates or agents, but only to the extent such
Losses result from (i) any Other Stressgen Development Activity which has not
been included under the Development Plan as provided in Section 7.3(d); (ii)
any co-promotion activity by Stressgen under Section 10.3, or (iii) the
negligence or misconduct or failure to act of Stressgen, its agents or
sublicensees, and do not result from the negligence or misconduct or failure to
act of Roche, its agents or sublicensees.

17.2        Indemnification by Roche. 
Unless otherwise provided herein, Roche shall indemnify, hold harmless
and defend Stressgen and its directors, officers, employees and agents from and
against any and all Losses, and any amounts Stressgen becomes legally obligated
to pay to a Third Party, including MIT, because of any claim or claims against
it to the extent that such claim or claims arise out of (a) a breach of a
representation or warranty by Roche under Article 15 or (b) the use,
development, handling, storage, manufacture, sale or other disposition of
Target Product conducted by or on behalf of Roche, its Affiliates or
sublicensees, other than Stressgen, except to the extent such losses, expenses
and costs are due to the negligence or misconduct or failure to act of
Stressgen.

 

 

56

 

 

17.3        Procedure.  In the event
of a claim by a Third Party against a Party entitled to indemnification under
this Agreement (“Indemnified Party”), the Indemnified Party shall promptly
notify the other Party (“Indemnifying Party”) in writing of the
claim and the Indemnifying Party shall undertake and solely manage and control,
at its sole expense, the defense of the claim and its settlement.  The Indemnified Party shall cooperate with
the Indemnifying Party, including, as requested by the Indemnifying Party entering
into a joint defense agreement.   The
Indemnified Party may, at its option and expense, be represented in any such
action or proceeding by counsel of its choice. 
The Indemnifying Party shall not be liable for any litigation costs or
expenses incurred by the Indemnified Party without the Indemnifying Party’s
written consent.  The Indemnifying Party
shall not settle any such claim unless such settlement fully and
unconditionally releases the Indemnified Party from all liability relating
thereto, unless the Indemnified Party otherwise agrees in writing.

17.4        Insurance.  Each Party,
at its own expense, shall maintain product liability insurance in an amount
consistent with industry standards during the Term.  Each Party shall provide fifteen (15) days prior written notice
to any cancellation of its insurance program.

ARTICLE
18

DISPUTE RESOLUTIONS AND GOVERNING LAW

18.1        Disputes.  Unless
otherwise set forth in this Agreement, in the event of a dispute arising under
this Agreement between the Parties, the Parties shall refer such dispute to the
respective Executive Officers, and such Executive Officers shall attempt in
good faith to resolve such dispute.

18.2        Arbitration. 
If the Parties are unable resolve a given dispute pursuant to Section
18.1 within sixty (60) days of referring such dispute to the Executives, either
Party may have the given dispute settled by binding arbitration in the manner
described below:

 

 

 

57

 

 

(a)           Arbitration Request. 
If a Party intends to begin an arbitration to resolve a dispute arising
under this Agreement, such Party shall provide written notice (the “Arbitration
Request”) to the other Party of such intention and the issues for
resolution.  From the date of the
Arbitration Request and until such time as the dispute has become finally
settled, the running of the time periods as to which Party must cure a breach
of this Agreement becomes suspended as to the subject matter of the dispute.

(b)           Additional Issues. 
Within ten (10) business days after the receipt of the Arbitration
Request, the other Party may, by written notice, add additional issues for
resolution.

(c)           No Arbitration of
Patent/Confidentiality Issues.  Unless
otherwise agreed by the Parties, disputes relating to patents and
non-disclosure, non-use and maintenance of Confidential Information shall not
be subject to arbitration, and shall be submitted to a court of competent
jurisdiction.

(d)           Arbitration Procedure. 
Discovery shall be under the U.S. Federal Rules of Civil Procedure.  The Arbitration shall be held in the
continental U.S. under the rules of the American Arbitration Association
(“AAA”).  The arbitration shall be
conducted by three (3) arbitrators who are knowledgeable in the subject matter
at issue in the dispute.  One (1)
arbitrator will be selected by Stressgen, one (1) arbitrator will be selected
by Roche and the third arbitrator will be selected by mutual agreement of the
two (2) arbitrators selected by the Parties. 
The arbitrators may proceed to an award, notwithstanding the failure of
either Party to participate in the proceedings.  The arbitrators shall, within fifteen (15) calendar days after
the conclusion of the arbitration hearing, issue a written award and statement
of decision describing the essential findings and conclusions on which the
award is based, including the calculation of any damages awarded.  The arbitrators shall be authorized to award
compensatory damages, but shall NOT be authorized to award non-economic damages
or punitive damages, or to reform, modify or materially change this Agreement
or any other agreements contemplated hereunder.  The arbitrators also shall be authorized to grant any temporary,
preliminary or permanent equitable remedy or relief the arbitrators deem

 

 

58

 

 

just and equitable and
within the scope of this Agreement, including, without limitation, an
injunction or order for specific performance. 
The award of the arbitrators shall be the sole and exclusive remedy of
the Parties.  Judgment on the award
rendered by the arbitrators may be enforced in any court having competent
jurisdiction thereof, subject only to revocation on grounds of fraud or clear
bias on the part of the arbitrators. 
Notwithstanding anything contained in this Section 18.6 to the contrary,
each Party shall have the right to institute judicial proceedings against the
other Party or anyone acting by, through or under such other Party, in order to
enforce the instituting Party’s rights hereunder through specific performance,
injunction or similar equitable relief.

Each Party shall bear its
own attorneys’ fees, costs, and disbursements arising out of the arbitration,
and shall pay an equal share of the fees and costs of the arbitrators; provided,
however, that the arbitrators shall be authorized to determine
whether a Party is the prevailing Party, and if so, to award to that prevailing
Party reimbursement for its reasonable attorneys’ fees, costs and disbursements
(including, for example, expert witness fees and expenses, photocopy charges
and travel expenses), and/or the fees and costs of the arbitrators.  Absent the filing of an application to
correct or vacate the arbitration award as permitted by applicable law, each
Party shall fully perform and satisfy the arbitration award within fifteen (15)
days of the service of the award.

By agreeing to this
binding arbitration provision, the Parties understand that they are waiving
certain rights and protections which may otherwise be available if a dispute
between the Parties were determined by litigation in court, including, without
limitation, the right to seek or obtain certain types of damages precluded by
this provision, the right to a jury trial, certain rights of appeal, and a
right to invoke formal rules of procedure and evidence.

 

 

59

 

 

18.3        Governing Law. 
The Parties have made this Agreement in accordance with the laws of [* *
*], which laws shall govern this Agreement and under which laws construction of
this Agreement shall occur, without regard to its choice of law principles.

ARTICLE
19

MISCELLANEOUS

19.1        Agency.  Neither
Party is an employee, agent or representative of the other Party for any
purpose.  Each Party is an independent
contractor, not an employee or partner of the other Party.  Neither Party shall have the authority to
speak for, represent or obligate the other Party in any way without prior
written authority from the other Party.

19.2        Entire Agreement. 
This Agreement, including all Exhibits, embodies the entire
understanding of the Parties with respect to the subject matter hereof and
supercedes all previous communications, representations or understandings, and
agreements, whether oral or written, between the Parties relating to the subject
matter hereof.

19.3        Amendment.  No amendment
or modification hereof shall be valid or binding upon the Parties unless made
in writing and signed by authorized signing officers of both Parties expressly
stating that it is intended to amend or modify this Agreement.

19.4        Possible Restructuring of Transaction. 
In order to address certain corporate finance and taxation objectives of
either Party, at the request of either Party [* * *], Roche and Stressgen shall
discuss in good faith any amendment and restatement of this Agreement proposed
by a Party in order to achieve such objectives.  In no event shall any such amendment or restatement in order to
achieve such objectives disadvantage either Party with respect to the financial
arrangement of this Agreement.

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

60

 

 

19.5        Assignment.  This Agreement shall not be assigned or
transferred in part or in whole by any Party without the prior written consent
of the other; provided, however, that either Party, without notice and at
any time for any reason, may assign or transfer this Agreement in whole or in
part to (a) any of its Affiliates who agree to be bound by the terms and
conditions of this Agreement or (b) any successor of such Party as part of
consolidation or merger, corporate reorganization or sale of all or
substantially all of its business assets to which this Agreement relates
(provided that intellectual property rights of the acquiring party to such
transaction, if other than one of the Parties to this Agreement, shall not be
included in the technology licensed hereunder).  In the event of assignment or transfer to an Affiliate, the Party
making the assignment will remain liable and responsible for the performance
and observance of all its duties and obligations hereunder.  The rights and obligations of the Parties
under this Agreement shall be binding upon and inure to the benefit of the
successors and permitted assigns of the Parties.  Any assignment not in accordance with this Agreement shall be
void.

19.6        Notices.  Any notice
or other communication under this Agreement, unless otherwise specified, shall
be in writing and provided when delivered to the addressee at the address
listed below (a) on the date of delivery if delivered in person or
(b) three (3) days after mailing to the other Party by express mail or
overnight delivery service, which obtains a signed receipt:

In the case of Stressgen or SBC:

Stressgen
Biotechnologies, Inc.

10241 Wateridge
Circle Drive

Suite C200

San Diego,
California  92121

USA

Attn: General Counsel

With a copy to:

Cooley Godward LLP

Five Palo Alto
Square

3000 El Camino
Real

Palo Alto, CA  94306

Attn: Barbara A.
Kosacz, Esq.

 

 

61

 

 

In the case of Roche:

F.Hoffmann-La Roche Ltd

Grenzacherstrasse 124

CH-4070

Basel, Switzerland

Attn:  Corporate Law

and

Hoffmann-La Roche Inc.

340 Kingsland Street

Nutley, New Jersey 07110

Attn: Corporate Secretary

Either Party may change its address for communications by a notice in
writing to the other Party in  accordance
with this Section.

 

19.7        Force Majeure. 
Any prevention, delay or interruption of performance (collectively “Delay”)
by any Party under this Agreement shall not be a breach of this Agreement if and
to the extent caused by occurrences beyond the reasonable control of the Party
affected by the force majeure, including but not limited to acts of God,
embargoes, governmental restrictions, terrorism, strikes or other concerted
acts of workers, fire, flood, earthquake, explosion, riots, wars, civil
disorder, rebellion or sabotage.  The
affected Party shall immediately notify the other Party upon the commencement
and end of the Delay.  During the Delay,
any time for performance hereunder by either Party shall extend by the actual
time of Delay. If the Delay resulting from the force majeure exceeds six (6)
months, the other Party, upon written notice to the affected Party, may elect
to (a) treat such Delay as a material breach, or (b) extend the term
of this Agreement for an amount of time equal to the Delay.

19.8        Severability. 
If a court of competent jurisdiction holds any term or condition of this
Agreement unenforceable for any reason, interpretation of such term or
condition shall, if possible, achieve the intent of the Parties to this
Agreement.  If not capable of such
interpretation, the Parties shall in good faith seek to agree on an alternative
provision reflecting the intent of the Parties which is enforceable.  In such

 

 

62

 

 

event, all other terms,
conditions and provision of this Agreement shall be valid and enforceable to
the full extent.

19.9        No Right to Use Names. 
Except as otherwise provided herein, this Agreement provides no grant of
right to a Party, express or implied, to use in any manner the housemarks or
trademarks of the other Party or its Affiliates.

19.10      Bankruptcy.  All rights
and licenses granted under or pursuant to this Agreement by Roche or Stressgen
are, and will otherwise be deemed to be, for purposes of Section 365(n) of the
U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined
under Section 101 of the U.S. Bankruptcy Code. 
The Parties agree that the Parties, as licensees of such rights under
this Agreement, will retain and may fully exercise all of their rights and
elections under the U.S. Bankruptcy Code. 
The Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code,
the Party hereto that is not a party to such proceeding will be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property, and
same, if not already in their possession, will be promptly delivered to them
(a) upon any such commencement of a bankruptcy proceeding upon their
written request therefor, unless the Party subject to such proceeding elects to
continue to perform all of its obligations under this Agreement, or (b) if
not delivered under (a) above, following the rejection of this Agreement by or
on behalf of the Party subject to such proceeding upon written request therefor
by the non-subject Party.

19.11      Interpretation. 
All headings are for reference purposes only and shall not in any way
affect the meaning or interpretation of this Agreement. This Agreement
incorporates all exhibits as a part of this Agreement by reference.  The term “including” (or any variation
thereof such as “include”) shall be without limitation.  All dollar amounts referred to in this
Agreement are in US dollars.

 

 

63

 

 

19.12      Counterparts. 
The Parties may execute this Agreement in counterparts, each of which
the Parties shall deem an original, but all of which together shall constitute
one and the same instrument.

19.13      Waiver.  A waiver of
any default, breach or non-compliance under this Agreement is not effective
unless signed by the Party to be bound by the waiver.  No waiver will be inferred from or implied by any failure to act
or delay in acting by a Party in respect of any default, breach, non-observance
or by anything done or omitted to be done by the other Party.  The waiver by a Party of any default, breach
or non-compliance under this Agreement will not operate as a waiver of that
Party’s rights under this Agreement in respect of any continuing or subsequent
default, breach or non-compliance (whether of the same or any other nature).

[This space is intentionally left
blank.]

 

 

64

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement
in duplicate originals by their proper officers as of the date and year first
above written.

	
  STRESSGEN DEVELOPMENT CORPORATION

  THE CORPORATE SEVENTY LIMITED

  	
   

  	
  F. HOFFMANN-LA ROCHE LTD 

  
	
   

  	
   

  	
   

  
	
  By: 

  	
  /s/ Donna Stoute

  	
   

  	
  By:

  	
  /s/ M. Mulqueen

  	
   

  	
  /s/ B. Bollon

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Donna Stoute

  	
   

  	
  Name:

  	
  M. Mulqueen

  	
   

  	
  /s/ B. Bollon

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Assistant Secretary

  	
   

  	
  Title: 

  	
  Head of Operations, EVP
  PL

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  STRESSGEN BIOTECHNOLOGIES CORPORATION

  	
   

  	
  HOFFMANN-LA ROCHE INC.

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Daniel L.
  Korpolinski

  	
   

  	
  By:

  	
  /s/ Dennis E. Burns

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Daniel L. Korpolinski

  	
   

  	
  Name:

  	
  Dennis E. Burns

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  President & Chief
  Executive Officer

  	
   

  	
  Title:

  	
  V.P. Global Head of
  Business Development

  
								

 

 

COLLABORATON
AGREEMENT

SIGNATURE PAGE

 

 

 

Exhibit A

Base Patents
as of Execution Date

A.            Product Specific Patents and Patent
Applications

A1.          Immune Responses Against HPV Antigens Elicited by
Compositions Comprising an HPV Antigen and a Stress Protein or an Expression
Vector Capable of Expression of These Proteins

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  Provisional

  	
  60/054,835

  	
  Aug.
  5, 1997

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  CA98/00246

  WO99/07860

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  EP

  	
  98910557.2

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  AU

  	
  64924/98

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  BR

  	
  P19812272-0

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  CA

  	
  2,298,840

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  CN

  	
  98809121.6

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  CZ

  	
  PV422-2000

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  HU

  	
  P0003601

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  HK

  	
  00107543.7

  	
   

  	
   

  	
   

  
	
  IL

  	
  134,341

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  JP

  	
  2000-50634

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  KR

  	
  10-2000-7001231

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  MX

  	
  0001299

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  NZ

  	
  502568

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  PL

  	
  P-338478

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  SG

  	
  200000450-7

  	
  Mar.
  20, 1998

  	
   

  	
   

  
	
  VN

  	
  S2000
  0175

  	
  Mar.
  20, 1998

  	
   

  	
   

  

 

A2.          Human Papilloma Virus Treatment

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  Provisional

  	
  60/214,202

  	
  June
  26, 2000

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  US
  01/20240

  WO
  02/00242

  	
  June
  26, 2001

  	
   

  	
   

  

 

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

A-1

 

B.            Non-Product Specific Patents and Patent Applications

B1.           Immune Responses Using Compositions Comprising Stress
Proteins

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US

  	
  08/756,621

  	
  Nov.
  26, 1996

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  CA97/00897

  WO98/23735

  	
  Nov.
  25, 1997

  	
   

  	
   

  
	
  AU

  	
  51120/98

  	
  Nov.
  25, 1997

  	
  736318

  	
  July
  26, 2001

  
	
  CA

  	
  2,272,536

  	
  Nov.
  25, 1997

  	
   

  	
   

  
	
  EP

  	
  97945684.5

  	
  Nov.
  25, 1997

  	
   

  	
   

  
	
  HK

  	
  00101484.1

  	
  Nov.
  25, 1997

  	
   

  	
   

  
	
  JP

  	
  10-524081

  	
  Nov.
  25, 1997

  	
   

  	
   

  

 

B2.           Induction of a Th1-Like Response in Splenocytes by Fusion
Proteins Comprising a Stress Protein Moiety

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  Provisional

  	
  60/143,757

  	
  July
  8, 1999

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  US
  00/18828

  	
  July
  10, 2000

  	
   

  	
   

  
	
  CA

  	
  2,378,097

  	
  July
  10, 2000

  	
   

  	
   

  
	
  CN

  	
  00811166.9

  	
  July
  10, 2000

  	
   

  	
   

  
	
  EP

  	
  00945300.2

  	
  July
  10, 2000

  	
   

  	
   

  
	
  JP

  	
  2001-509547

  	
  July
  10, 2000

  	
   

  	
   

  
	
  SG

  	
  200108092-8

  	
  July
  10, 2000

  	
   

  	
   

  

 

(the following patents are [*], patents)

 

B3.           Stress Proteins And Uses Therefor

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US

  	
  07/207,298

  	
  June
  15, 1988

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  US89/02619

  WO89/12455

  	
  June
  15, 1989

  	
   

  	
   

  
	
  CA

  	
  602,924

  	
  June
  15, 1989

  	
  1,338,778

  	
  Dec.
  10, 1996

  

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

A-2

 

 

B4.          Stress Proteins And Uses Therefor

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  

  	
  08/073,381

  	
  June
  4, 1993

  	
   

  	
   

  
	
  US

  	
  08/336,251

  	
  Nov.
  3, 1994

  	
  6,338,952

  	
  Jan.
  15, 2002

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  US
  

  	
  08/461,722

  	
  June
  5, 1995

  	
  6,335,183

  	
  Jan.
  1, 2002

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  US94/06362

  WO94/29459

  	
  June
  6, 1994

  	
   

  	
   

  
	
  CA

  	
  2,164,298

  	
  June
  6, 1994

  	
   

  	
   

  
	
  EP

  	
  94919384.1

  	
  June
  6, 1994

  	
  700,445
  B1

  	
  Jan.
  23, 2002

  
	
  EP
  

  	
  01203598.6

  	
  Sept.
  21, 2001

  	
   

  	
   

  
	
  JP

  	
  7.502024

  	
  June
  6, 1994

  	
   

  	
   

  

 

B5.          Use of Heat Shock Proteins to Deliver
Moieties

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  Provisional

  	
  60/038,059

  	
  Feb.
  18, 1997

  	
   

  	
   

  
	
  US
  Provisional

  	
  60/066,288

  	
  Nov.
  25, 1997

  	
   

  	
   

  
	
  US

  	
  09/025,178

  	
  Feb.
  18, 1998

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  CA

  	
  2,282,426

  	
  Feb.
  18, 1998

  	
   

  	
   

  
	
  EP

  	
  98906495.1

  	
  Feb.
  18, 1998

  	
   

  	
   

  

 

B6.           In Vivo CTL Elicitation by Heat Shock Protein Fusion
Proteins Maps to a Discrete Domain and is CD4+ T Cell-Independent

	
  Country

  	
  Serial
  No.

  	
  Filing
  Date

  	
  Patent
  No

  	
  Issue
  Date

  
	
  US
  Provisional

  	
  60/176,143

  	
  Jan.
  14, 2000

  	
   

  	
   

  
	
  [*]

  	
  [*]

  	
  [*]

  	
   

  	
   

  
	
  PCT

  	
  US00/32831

  	
  Dec.
  01, 2000

  	
   

  	
   

  

 

 

[*]=CONFIDENTIAL TREATMENT REQUEST(ED).

 

 

A-3

 

EXHIBIT B

OTHER STRESSGEN DEVELOPMENT ACTIVITIES

 

 

1. [***]

 

2. [***]

 

3. [***]

 

 

[*]—CONFIDENTIAL TREATMENT REQUEST(ED).

 

B-1

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