Document:

exv4w16

 

EXHIBIT 4.16

Confidential treatment has been requested for certain portions of
this exhibit. The copy filed herewith omits the information subject
to the confidential treatment request. Omissions are designated as
“[*****]” or “*****”. A complete
version of this exhibit has been filed separately with the Commission
pursuant to an application for confidential treatment under
Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended.

LICENSE AGREEMENT

between

BAXTER VACCINE AG

and

ACAMBIS INC.

 

 

CONTENTS

	 	 	 	 	 	 	 
	Clause	 	 	 	Page
	 	 	 	 	 
	1	 	
INTERPRETATION
	 	 	1	 
	2	 	
GRANT
	 	 	3	 
	3	 	
PAYMENTS
	 	 	3	 
	4	 	
PROVISION OF KNOW-HOW AND BIOLOGIC MATERIAL
	 	 	4	 
	5	 	
OBLIGATIONS OF THE LICENSEE
	 	 	5	 
	6	 	
IMPROVEMENTS
	 	 	6	 
	7	 	
INTELLECTUAL PROPERTY RIGHTS
	 	 	6	 
	8	 	
TECHNICAL ASSISTANCE
	 	 	7	 
	9	 	
INFRINGEMENT
	 	 	7	 
	10	 	
CONFIDENTIALITY
	 	 	9	 
	11	 	
TERM AND TERMINATION
	 	 	10	 
	12	 	
CONSEQUENCES OF TERMINATION
	 	 	11	 
	13	 	
ADEQUACY OF DAMAGES
	 	 	12	 
	14	 	
ASSIGNMENT AND SUB-LICENSING
	 	 	12	 
	15	 	
GENERAL
	 	 	12	 
	16	 	
NOTICES
	 	 	13	 
	17	 	
GOVERNING LAW
	 	 	13	 
	18	 	
JURISDICTION
	 	 	14	 

2

 

THIS AGREEMENT is made on this 20th of December, 2002

BETWEEN:

	 	 	 
	(1)	 	 BAXTER VACCINE AG, a
      company of Austria, whose principal place of business is at Industriestrasse
      67, A-1221 Vienna, Austria (the “Licensor”); and
	 	 	  
	(2)	 	 ACAMBIS INC, a company
      organized and existing under the laws of the State of Delaware, whose principal
      place of business is at 38 Sidney Street, Cambridge, Massachusetts 02139,
      USA (the “Licensee”).

INTRODUCTION:

	 	 	 
	(A)	 	 The Licensor is possessed of
      the Know-How.
	 	 	  
	(B)	 	 The Licensor has agreed to license
      the Licensee to use the Know-How upon the terms and conditions of this Agreement.

THE PARTIES AGREE as follows:

	 	 	 
	1	 	 INTERPRETATION
	 	 	  
	1.1	 	 In this Agreement:

	 	 
	 	“Affiliate” means, in relation
      to a person, (i) any corporation or business entity fifty percent (50%)
      or more of the voting stock of which is and continues to be owned directly
      or indirectly by that person; (ii) any corporation or business entity which
      directly or indirectly owns fifty percent (50%) or more of the voting stock
      of that person; or (iii) any corporation or business entity under the direct
      or indirect control of such corporation or business entity described in
      (i) or (ii);
	 	 
	 	“Baxter Person” means (i) Baxter,
      (ii) any member of the Baxter Group and (iii) any person or persons
      with whom Baxter or any member of the Baxter Group are acting in concert
      in relation to the Licensee but (for the avoidance of doubt) will not include
      employees of Baxter Group other than those with responsibilities in relation
      to Baxter’s relationship with the Licensee pursuant to this Agreement;
	 	 
	 	“Biologic Material” means a working
      cell bank of Vero Cell Line;
	 	 
	 	“Change Control” means the
      acquisition by any person or persons (other than a Baxter Person or any
      Baxter persons and any Baxter persons in a concert party with non-Baxter
      Persons shall be disregarded in determining whether there has been a Change
      of Control) who in relation to each other are acting in concert of such
      number of shares in Acambis plc which , when added to any shares in Acambis
      plc already held or controlled by them, confer in aggregate more than fifty
      per cent (50%) of the total voting rights conferred by all the shares in
      the capital of Acambis plc for the time being in issue and having the right
      to attend and vote at general meetings of Acambis plc;
	 	 
	 	“Field of Use” means the development
      and commercialization of the Product;

 

 

2 

	 	 	 
	 	 	 “Improvement” means
      any improvement, modification or alteration to the Product or the Know-How,
      including any such improvement, modification or alteration of the Biologic
      Material, protein free culture media or procedure for affecting the infection
      of the Vero Cell Lines with the Smallpox virus, provided that such Improvement
      shall not include any improvement, modification or alteration of the Smallpox
      virus owned or used by Licensee to manufacture the Product;
	 	 	  
	 	 	 “Know-How” means
      Biologic Material and technical information concerning the use of Biologic
      Material for the making, using and/or selling the Product including media
      formulation, which is owned, licensed to or otherwise held and known by
      the Licensor with the right to license or sub-license such information;
	 	 	  
	 	 	 “Net Multivalent Price”
      means the net average selling price in any given quarter of any multivalent
      vaccines containing a Product sold by the Licensee, being the gross invoice
      price before deduction of any discounts or allowances given and after deduction
      of any charges for freight or insurance and any tax or duty charged to the
      purchaser;
	 	 	  
	 	 	 “Net Product Price”
      means the net average selling price in any given quarter of a Product sold
      by the Licensee, being the gross invoice price before deduction of any discounts
      or allowances given and after deduction of any charges for freight or insurance
      and any tax or duty charged to the purchaser;
	 	 	  
	 	 	 “Product” means
      Smallpox Vaccine (vaccinia) produced using the Biologic Material according
      to the Know-How provided by the Licensor;
	 	 	  
	 	 	 “Smallpox Vaccine”
      means a vaccine either therapeutically or prophylactically active against
      the Smallpox virus produced using Vero Cell Line;
	 	 	  
	 	 	 “Termination Date”
      means the date upon which this Agreement is terminated under the provisions
      of this Agreement;
	 	 	  
	 	 	 “Territory” means
      the world;
	 	 	  
	 	 	 “Vero Cell Line”
      means African Green Monkey (Ceropithecus aethiops) kidney vero cells supplied
      by the Licensor including cells at passage #133 derived from cells obtained
      from the ATCC at passage #124 under the designation ATCC CCL81; and
	 	 	  
	 	 	 “Year” means each
      consecutive period of twelve (12) months during the currency of this
      Agreement, beginning on the Commencement Date and each anniversary of the
      Commencement Date.
	 	 	  
	1.2	 	 In this Agreement, a reference
      to:

	 	 	 	 
	 	1.2.1	 	 a person includes a reference
      to a corporation, body corporate, association or partnership;
	 	 	 	  
	 	1.2.2	 	 a person includes a reference
      to that person’s legal personal representatives, successors and permitted
      assigns; and
	 	 	 	  
	 	1.2.3	 	 a clause or schedule, unless
      the context otherwise requires, is a reference to a clause of or schedule
      to this Agreement.

 

 

3 

	 	 	 
	1.3	 	 The headings in this Agreement
      do not affect its interpretation.
	 	 	  
	2	 	 GRANT
	 	 	  
	2.1	 	 The Licensor grants to the Licensee,
      with a right to grant sub-licenses only to Affiliates, the sole right and
      license within the Field of Use to use the Know-How and any Improvements,
      to manufacture, use and sell the Product in the Territory for the duration
      of this Agreement. The Licensee agrees further not to disclose such Know-How
      or any information obtained by utilizing the same, to any third party.
	 	 	  
	2.2	 	 The Licensee shall not use the
      Know-How for any purpose other than that permitted under clause 2.1. For
      the avoidance of doubt, the Licensee shall not use the Know-How in connection
      with any product other than the Product or any cell line other than the
      Vero Cell Line.
	 	 	  
	2.3	 	 Notwithstanding the provisions
      of clause 2.1, the Licensor shall itself be entitled to use the Know-How
      for any purpose, including (but without limitation) for the purposes of
      manufacturing, using and/or selling vaccines similar to or which compete
      with the Product to the extent not prohibited under the Subcontract entered
      into on November 14th, 2001 or the Distribution, Manufacturing and
      Licence Agreement entered into in December 2002.
	 	 	  
	2.4	 	 The Licensee agrees that it
      will only utilize the Know-How and/or the Biologic Material for manufacturing
      and developing the Product in serum-free cell culture media or serum-free
      and protein-free cell culture media. The Licensee further agrees that it
      will in particular not utilize any cell banks provided under this Agreement
      to create new master cell bank(s), nor shall it alter the Know How, including
      the media formulation in order to use it for purposes outside the scope
      of this Agreement.
	 	 	  
	2.5	 	 The Licensee shall use reasonable
      efforts to promote and extend the sale of the Product including the allocation
      of sufficient resources, capital, equipment, materials and labor to make
      the Product readily available throughout the Territory, having regard to
      the Licensee’s resources, the size and accessibility of each market,
      to all potential purchasers and shall provide such advertising and promotion
      as may reasonably be expected to bring the Product to the attention of as
      many such purchasers as possible.
	 	 	  
	2.6	 	 The Licensee shall indemnify
      the Licensor on demand against each loss, liability and cost which the Licensor
      incurs arising out of the Licensee’s use of the Know-How (including,
      without limitation, each loss, liability and cost reasonably incurred by
      the Licensor as a result of defending or settling a claim alleging such
      a liability).
	 	 	  
	3	 	 PAYMENTS
	 	 	  
	3.1	 	 The Licensee shall pay to the
      Licensor a royalty of [* * * * ] percent ([* *]%) of
      the Net Product Price provided that such royalty has not already been paid
      under the Distribution, Manufacturing and License Agreement entered into
      in December 2002.

 

 

4 

	 	 	 
	3.2	 	 The Licensee shall within thirty
      (30) days after the last days of March, June, September and December
      in each Year and three (3) months after the Termination Date send to
      the Licensor a statement showing the quantity, description and Net Product
      Price or Net Multivalent Price (as appropriate) of the Products sold by
      the Licensee during the three (3) months (or such shorter period as may
      be applicable) ending on that day and showing the amount of royalty due
      under this Agreement in respect of the relevant period. With each statement
      the Licensee shall send a remittance to the Licensor for the total aggregate
      amount of royalty shown by that statement to be due.
	 	 	  
	3.3	 	 The Licensee shall keep proper
      records and books of account showing the quantity, description and Net Product
      Prices or Net Multivalent Price (as appropriate) of the Products sold under
      this Agreement. These records and books of accounts shall be, so far as
      practicable, kept separate from any books and records not relating solely
      to the Products and shall be open at all times to inspection on behalf of
      the Licensor by an independent accounting firm to be agreed between the
      parties, or, in the event of the parties failing to agree, by an independent
      accounting firm nominated at the request of either party by the then President
      of the US Institute of Public Accountants.
	 	 	  
	3.4	 	 The royalty payable to the Licensor
      in respect of a sale of the Products by the Licensee to an Affiliate or
      to a third party otherwise associated with or acting in concert with the
      Licensee shall be that which would be payable on a sale of the Products
      at full market value payable by a purchaser at arm’s length unless
      the price actually paid by the purchaser exceeds such market value and Net
      Product Price or Net Multivalent Price (as appropriate) shall be construed
      accordingly.
	 	 	  
	3.5	 	 All sums payable under this
      Agreement shall be paid in US Dollars. Any Net Product Price or Net Multivalent
      Price (as appropriate) not expressed in US Dollars shall be converted to
      US Dollars at the open middle market spot rate of exchange in London as
      published in the Financial Times (or, failing that, such other published
      source as the Licensor may reasonably select) on the last day of the relevant
      period referred to in clause 3.2.
	 	 	  
	3.6	 	 All amounts payable by the Licensee
      under this Agreement shall be paid in full without any withholding or deduction,
      whether on account of any set-off, taxes, duties, levies or charges or otherwise,
      unless the Licensee is required by law or by a ruling of a tax authority
      to make such deduction or withholding. The parties shall take all reasonable
      action as may be necessary at their own expense to ensure that royalties
      may be paid under this Agreement without any such deductions or withholding.
	 	 	  
	4	 	 PROVISION OF KNOW-HOW AND
      BIOLOGIC MATERIAL
	 	 	  
	4.1	 	 The Licensor shall forthwith
      disclose to the Licensee all the Know-How in the possession of the Licensor,
      which is in documentary form. Licensee agrees that all such Know-How is
      confidential and proprietary to Licensor and that access to such Know How
      shall be restricted to those employees, who due to their specific function
      need to have access to the Know How and Biologic Material in whole or in
      part. Licensee shall implement and maintain high standard procedures to
      protect the Know-

 

 

5 

	 	 	 
	 	 	
How and Biologic Material as confidential operating secrets in its facilities and to prevent its employees
from intentionally or accidentally disclosing Know-How and Biologic Material. Such procedures shall include
where appropriate confidentiality agreements. Upon request Baxter may audit such procedures at appropriate
business hours giving business 10 days notice in advance.
	 	 	
 
	4.2	 	
Licensee shall take care of translation of documentation into English when required.
	 	 	
 
	4.3	 	
Neither party shall be obliged to disclose any information to the other
if it is prevented from doing so by an obligation to another person
provided however that the parties agree to make all reasonable efforts to
obtain consent to disclose such information. If that obligation is not
absolute but is conditional upon the observance of conditions there shall
be no obligation to make such disclosure except against an undertaking to
observe such conditions. Each party warrants and represents to the other
that it is not aware of any requirement for it to obtain the consent of a
third party before disclosing any such information to the other.
	 	 	
 
	4.4	 	
The Licensor shall promptly after the date of this Agreement provide the
Licensee with a sufficient quantity of Biologic Material for it to
commence the development of the Products. Thereafter during the term of
this Agreement the Licensor shall, subject to availability and reasonable
notice from Licensee, provide the Licensee with such further Biologic
Material as the Licensee may from time to time request. All Know-How,
including, but without limitation, all such Biologic Material, shall
remain the property of the Licensor. For the avoidance of doubt, the
master cell bank of Vero Cell Line from which the Licensor produces the
Biologic Material, which it supplies to the Licensee shall remain the
property of and in the possession and control of the Licensor. The
Licensee shall retain ownership of the Smallpox virus strains, which it
owns at the date of this Agreement or, in the future, develops, and no
license in respect thereof is granted to the Licensor under this
Agreement.
	 	 	
 
	4.5	 	
Except as required by a competent regulatory authority, and then subject
to consulting with the Licensor, the Licensee shall not investigate,
analyze, reverse engineer or make any other attempts to gain an
understanding of the composition of the Biologic Material, provided that
the provisions of clause 10 shall apply to any such understanding gained
in the course of complying with a request of a competent regulatory
authority.
	 	 	
 
	5.	 	
OBLIGATIONS OF THE LICENSEE
	 	 	
 
	5.1	 	
The Licensee shall comply with all applicable laws, rules, regulations
and orders applicable to the manufacture, sale and use of the Products.
	 	 	
 
	5.2	 	
Upon request of the Licensor, the Licensee shall provide the Licensor
with a detailed report on the utilization of Biological Material. In
addition the Licensee shall upon request certify to the Licensor that
neither Biological Material nor Know-How or parts thereof have been or are
utilized for the development and commercialization of any vaccines not
covered by License Agreements between Licensor and Licensees and/or their
Affiliates.

 

 

6 

	 	 	 
	5.3	 	 The Licensee shall indemnify
      the Licensor against all losses, liabilities and costs which the Licensor
      may incur arising from or in connection with the Licensee’s breach
      of any of it’s obligations under this clause, clause 2 and clause 10.
	 	 	  
	5.4	 	 If the Licensor becomes aware
      of a matter which might give rise to a claim under the indemnity given to
      it in clause 5.3, it shall as soon as practicable notify the Licensee of
      the matter, stating in reasonable detail the nature of the matter and, if
      practicable the amount claimed.
	 	 	  
	5.5	 	 The Licensee shall have the
      conduct of the defense, settlement, compromise, counterclaim and any third
      party proceedings in respect of any such claims (“Conduct”) provided
      that the Licensee shall keep the Licensor regularly informed as to the conduct
      thereof.
	 	 	  
	5.6	 	 The Licensee may not admit liability
      in respect of or settle any such proceedings without first obtaining the
      Licensor’s written consent. Should the Licensor withhold such consent,
      the Licensee shall thereupon be entitled to return the Conduct to the Licensor
      and, upon that return, shall be released from its obligation under clause
      5.3 to indemnify the Licensor in respect of the matter the Conduct of which
      the Licensee is returning to the Licensor, who shall then be responsible
      for all costs reasonably incurred by the Licensee in the course of the Conduct.
	 	 	  
	6.	 	 IMPROVEMENTS
	 	 	  
	6.1	 	 If the Licensee makes or acquires
      any Improvement it shall promptly notify the Licensor in writing giving
      details of the Improvement and shall provide to the Licensor free of charge
      such information or explanations as the Licensor may reasonably require
      to be able legally and effectively to utilize the Improvement. The Licensee
      hereby grants to the Licensor a non-exclusive worldwide royalty-free license
      (with the right to sub-license Affiliates and, with the prior written consent
      of the Licensee, to license third parties, provided however that such consent
      shall not be required where the use of an Improvement of the Licensee is
      necessary to utilize an improvement of the Licensor) to use the Improvements
      disclosed by the Licensee under this Agreement.
	 	 	  
	6.2	 	 If the Licensor makes or acquires
      any Improvement, it shall promptly notify the Licensee in writing giving
      details of the Improvement and shall provide the Licensee with such information
      or explanations at no additional charge as the Licensee may reasonably require
      to be able legally and effectively to utilize the Improvement and any such
      Improvement shall be deemed Know-How and subject to the terms and conditions
      of this Agreement.
	 	 	  
	7.	 	 INTELLECTUAL PROPERTY RIGHTS
	 	 	  
	7.1	 	 The Licensor warrants and represents
      to the Licensee that the Licensor:
	 	 	  

	 	 	 	 
	 	7.1.1	 	 owns the Know-How;

 

 

7 

  	 	 	 	 
	 	7.1.2	 	 has the right to grant to
        the Licensee the rights and licenses hereby granted or agreed to be granted;
	 	 	 	  
	 	7.1.3	 	 has not, at the date of this
        Agreement, received notice of any third party claims alleging that the
        Licensor’s use of the Vero Cell Line or the Know-How infringes any
        third party right; and
	 	 	 	  
	 	7.1.4	 	 has not granted and will not
        grant or purport to grant any other licenses, rights, assignments over
        or relating to the Know-How in the Field of Use during the term of this
        Agreement.

	 	 	 
	7.2	 	 The Licensor does not warrant
      or represent that the Know-How:
	 	 	  

	 	 	 	 
	 	7.2.1	 	 will enable specific results
      to be obtained; 
	 	 	 	 
	 	7.2.2	 	 is comprehensive within its
      field;
	 	 	 	  
	 	7.2.3	 	 are suitable for the Licensee’s
      purposes;
	 	 	 	  
	 	7.2.4	 	 does not infringe the rights
      of any third party; or
	 	 	 	  
	 	7.2.5	 	 that the Know-How will not cause
      any loss, damage or injury when used.

	 	 
	8. 	TECHNICAL ASSISTANCE
	 	 
	 	During the term of this Agreement the Licensor
      shall, as and when reasonably requested by the Licensee, provide such technical
      assistance and advice as the Licensee reasonably requires and the Licensor
      is in a position to provide in connection with the development of the Products
      and, for any technical assistance and advice given in excess of twenty (20) working
      days, the Licensee shall reimburse the Licensor all the Licensor’s
      employment costs, travel, subsistence, out of pocket and other expenses
      attributable to the provision of such advice and assistance. The Licensor’s
      obligation to provide such technical assistance shall be at its reasonable
      discretion and a failure to provide the same at the specific time so requested
      by the Licensee, if the Licensor provides the Licensee with prior notice
      of its inability to do so, shall not constitute a breach of this Agreement
	 	 
	9.	 INFRINGEMENT
	 	 
	9.1	 The Licensee shall promptly give the Licensor
      notice in writing in the event that it becomes aware of:
	 	 

	 	 	 	 
	 	9.1.1	 	 any infringement or suspected
      infringement of the Know-How or any patents owned by the Licensor; and
	 	 	 	  
	 	9.1.2	 	 any claim that any Product or
      the manufacture, use or sale of any Product infringes the rights of any
      third party.

 

 

8 

	 	 
	9.2	 In the case of any matter falling within
      clause 9.1.1:

	 	
	 	 
	 	9.2.1	 	 Licensor shall have the absolute
      and sole discretion to determine what action if any shall be taken in respect
      of such matter;
	 	 	 	  
	 	9.2.2	 	 Licensor shall have sole control
      over and shall conduct any such action as it shall deem necessary in pursuance
      of clause 9.2.1; and
	 	 	 	  
	 	9.2.3	 	 Licensor shall pay all costs
      in connection with such action and shall be entitled to all damages and
      other sums which may be paid or awarded as a result of any such action.

	 	 
	9.3	 In the case of any matter falling within
      clause 9.1.2:

	 	 	 	 
	 	9.3.1	 	 the Licensor and the Licensee
      shall consult to decide whether such alleged infringement involves the use
      of the Know-How or Biologic Material provided to Licensee by Licensor under
      this Agreement;
	 	 	 	  
	 	9.3.2	 	 if the parties determine that
      such alleged infringement involves the use of Know-How or Biologic Material
      then they shall consult to determine what steps may be taken to handle such
      allegations, including steps to alter the use of such Know-How or Biologic
      Material and the proportions in which they shall share the cost of such
      steps and any damages and other sums which may be awarded in their favor
      or against them;
	 	 	 	  
	 	9.3.3	 	 failing agreement between the
      parties under clause 9.3.1 or 9.3.2, either party (but in the case of the
      Licensee, only with the prior written consent (such consent not to be unreasonably
      withheld or delayed) of the Licensor) shall be entitled to take all such
      action as it shall consider to be necessary or appropriate at its own expense
      to defend such claim and shall be entitled and subject to all damages and
      other sums which may be recovered or awarded against it as a result of any
      such action; provided that neither party shall take any action that compromises
      the other party’s rights, including any action taken by Licensee which
      could compromise Licensor’s rights to use Know-How or Biologic Material
      without the written consent and agreement of the other.

	 	 	 
	9.4	 	 Each party shall, at the request
      and expense of the other, provide all reasonable assistance to the other
      (including but not limited to the use of its name in or being joined as
      a party to proceedings) in connection with any action to be taken by the
      other party pursuant to this clause.
	 	 	  
	9.5	 	 The Licensor hereby undertakes
      to the Licensee that, in the event of any process employed by the Licensee
      in the manufacture of the Products infringing a patent which the Licensor
      owns or controls, the Licensor covenants not to sue Licensee, or any Affiliate
      to which it has granted a sub-license under the terms of this Agreement
      in respect of such infringement provided however that this covenant not
      to sue shall only apply to the Licensee and any such Affiliate, and shall
      not be transferable to any other party.

 

 

9 

	 	 	 
	10	 	 CONFIDENTIALITY
	 	 	  
	10.1	 	 In this clause 10 “Confidential
      Information” means any information disclosed (including, in the case
      of the Licensor, the Know-How), whether in writing, orally or by another
      means and whether directly or indirectly, by a party (the “Disclosing
      Party”) to the other party (the “Receiving Party”) whether
      before or after the date of this Agreement including, without limitation,
      any information relating to the Disclosing Party’s business affairs.
	 	 	  
	10.2	 	 During the term of this Agreement
      and after termination or expiration of this Agreement for any reason whatsoever
      the Receiving Party shall:

  	 	 	 	 
	 	10.2.1	 	 keep the Confidential Information
        confidential, separate from all other information and stored in a manner
        designed to restrict access to those persons entitled to such access;
	 	 	 	  
	 	10.2.2	 	 not disclose the Confidential
        Information to any other person other than with prior written consent
        of the Disclosing Party or in accordance with clauses 10.3 and 10.4; and
	 	 	 	  
	 	10.2.3	 	 not use the Confidential Information
        for any purpose other than the enjoyment of its rights and the performance
        of its obligations under this Agreement.

  	 	 	 

  	10.3	 	 During the term
        of this Agreement the Receiving Party may disclose Confidential Information
        to those of its employees (a “Recipient”) whom the Disclosing
        Party has approved in writing and then only to the extent that it is reasonably
        necessary for the purposes of this Agreement.
	 	 	  
	10.4	 	 Before disclosure of any Confidential
        Information to a Recipient, the Receiving Party shall procure that the
        Recipient is made aware of and complies with the Receiving Party’s
        obligations of confidentiality under this Agreement as if the Recipient
        was a party to this Agreement.
	 	 	  
	10.5	 	 The Licensee shall, before
        giving access to any Confidential Information to any of its employees,
        first secure that such employees sign an enforceable confidentiality undertaking
        on terms at least equivalent to the Licensee’s obligations hereunder.
	 	 	  
	10.6	 	 Clauses 10.2 to 10.5 do not
        apply to Confidential Information which is at the date of this Agreement,
        or at any time after that date, becomes publicly known other than by the
        Receiving Party’s or a Recipient’s breach of this Agreement
        provided however that it shall be the responsibility of the Licensee to
        demonstrate to the reasonable satisfaction of the Licensor that such Confidential
        Information is publicly known before disclosing it other than in accordance
        with the provisions of this clause. Furthermore, but in the case of the
        Licensor only, clauses 10.2 to 10.5 do not apply to any Confidential Information
        relating to any Improvements. The public availability of a general description
        of any information contained within the Confidential Information does
        not release the Receiving Party from its obligation to maintain the confidentiality
        of more specific descriptions of such information which are provided by
        the Disclosing Party.

 

 

10 

  	 	 	 	 
	 	10.7	 	 Should the Licensee be obliged
        by a competent regulatory authority to disclose any Confidential Information
        to that authority, the Licensee shall first notify the Licensor and allow
        the Licensor a reasonable period of time either to contest such disclosure
        or to provide such disclosure under suitable confidentiality restrictions,
        failing which the Licensee shall be free to disclose the Confidential
        Information requested by that authority. In any event the Licensee shall
        advise that authority of the confidential nature of any Know-How and Confidential
        Information so disclosed.
	 	 	 	  
	 	11	 	 TERM AND TERMINATION
	 	 	 	  
	 	11.1	 	 This Agreement shall come
        into force on the date first set out above and, unless terminated at an
        earlier date pursuant to this clause 11, shall remain in full force and
        effect.
	 	 	 	  
	 	11.2	 	 Either party (the “Initiating
        Party”) may terminate this Agreement with immediate effect by written
        notice to the other party (the “Breaching Party”) on or at any
        time after the occurrence of an event specified in clause 11.3 in relation
        to the Breaching Party.
	 	 	 	  
	 	11.3	 	 The events are:

  	 	 	 	 
	 	11.3.1	 	 the Breaching Party being
        in material breach of any of its obligations under this Agreement and,
        if the breach is capable of remedy, failing to remedy the breach within
        thirty (30) days starting on the day after receipt of written notice
        from the Initiating Party giving full details of the breach and requiring
        the Breaching Party to remedy the breach and stating that a failure to
        remedy the breach may give rise to termination under this clause. For
        the purposes of this clause 11.3.1 a breach is capable of remedy if time
        is not of the essence in performance of the obligation and if the Breaching
        Party can comply with the obligation within the thirty (30) day period;
	 	 	 	  
	 	11.3.2	 	 files in any court, pursuant
        to any statute of any government in any country, a petition in bankruptcy
        or insolvency or for reorganization, or for an arrangement or for the
        appointment of a receiver or trustee of the party or of its assets; or
        proposes a written agreement of composition for extension of its debts;
        or is served with an involuntary petition against it, filed in any insolvency
        proceeding and such petition is not dismissed within sixty (60) days
        after filing thereof; or is subject to any dissolution or liquidation,
        or makes a general assignment for the benefit of its creditors; or is
        subject to any final order or debarment which can be expected to have
        a material adverse effect on the sale of the Product; and
	 	 	 	  
	 	11.3.3	 	 the Licensee agrees that the
        Know-How provided under this Agreement shall be security for any monetary
        amounts owed under this Agreement, and further agrees that the Licensor
        shall be entitled to file a notice of a security interest in the Know-How
        for such amounts owed.

	 	 	 	 
	 	11.4	 	 In the event of any Change of
      Control of Acambis plc or in the event that the Licensee ceases to be an
      Affiliate of Acambis plc, the Licensee shall forthwith notify the

 

 

11 

	 	 	 	 
	 	 	 	Licensor (such disclosure being
      kept confidential by the Licensor until it
      becomes a matter of public knowledge.) Licensor shall have the option to
      (a) consent or (b) take over manufacture of bulk vaccine at Licensor's actual
      cost (plus direct overheads) plus a margin of fifty percent whereby the
      calculations of cost and overheads are defined in the Canton Manufacturing
      Agreement dated December 5, 2000. In the event of a Change of Control of
      an Affiliate to whom the Licensee has granted a sub- license under the terms
      of this Agreement, the same shall apply.
	 	 	 	 
	 	11.5	 	 The Licensor may terminate this
      Agreement with immediate effect by notice in writing to the Licensee if
      the Licensee at any time challenges the enforcement of any of the provisions
      of this Agreement.
	 	 	 	  
	 	11.6	 	 The Licensor may terminate this
      Agreement with immediate effect by notice in writing to the Licensee in
      the event that the Licensee has used the Know-How in connection with any
      product other than the Products, any cell line other than the Vero Cell
      Line, or is in breach of clause 2.2.
	 	 	 	  
	 	12	 	 CONSEQUENCES OF TERMINATION
	 	 	 	  
	 	12.1	 	 All rights and obligations of
      the parties shall cease to have effect immediately upon termination of this
      Agreement except that termination shall not affect:

	 	 	 	 
	 	12.1.1	 	 the accrued rights and obligations
      of the parties at the date of termination; and
	 	 	 	  
	 	12.1.2	 	 the continued existence and
      validity of the rights and obligations of the parties under those clauses
      which are expressed to survive termination and any provisions of this Agreement
      necessary for the interpretation or enforcement of this Agreement.

	 	 	 	 
	 	12.2	 	 On termination of this Agreement howsoever
      occasioned:

	 	 	 	 
	 	12.2.1	 	 (unless required to do otherwise
      by law or regulation) at the Licensor’s option the Licensee shall either
      forthwith return promptly to the Licensor or destroy all Know-How which
      is in documentary form, and all copies of such material, and any remaining
      portion of any Biologic Material provided by the Licensor. In the case of
      destruction the Licensee shall promptly provide to the Licensor a certificate
      in a form acceptable to the Licensor certifying that destruction has taken
      place;
	 	 	 	  
	 	12.2.2	 	 the Licensor may at its discretion
      grant the Licensee sufficient time to complete any clinical trials being
      conducted at such time and/or to sell existing stocks of the Products which
      were manufactured using the Know-How including stocks on order and in transit
      at that time, which period shall not exceed three (3) months;
	 	 	 	  
	 	12.2.3	 	 the Licensee shall immediately
      cease the manufacture of Products using the Know-How and the Cell Banks;
      and

 

 

12 

	 	 	 	 
	 	12.2.4	 	 if either party has a claim
      against the other there shall (in the absence of express written agreement
      between the parties in respect thereof) be no rights of set-off against
      any monies due from the other party.

	 	 	 
	13	 	 ADEQUACY OF DAMAGES
	 	 	  
	 	 	 The Licensor shall be entitled,
      upon the breach or threatened breach by the Licensee of any provision of
      this Agreement, to obtain a temporary restraining order and a subsequent
      injunction prohibiting such breach or threatened breach (as the case may
      be) and the Licensee shall not resist any application by the Licensor for
      any such order or injunction. The Licensee acknowledges that monetary damages
      will not be a sufficient and adequate remedy for the Licensor in respect
      of any such breach or threatened breach (as the case may be).
	 	 	  
	14	 	 ASSIGNMENT AND SUB-LICENSING
	 	 	  
	14.1	 	 Neither party shall assign or
      transfer or purport to assign or transfer any of its rights or obligations
      under this Agreement without the prior written consent of the other party,
      provided however that the Licensor may assign any of its rights or obligations
      under this Agreement to an Affiliate or to a successor in interest without
      the consent of the Licensee, provided that such assignment by Licensor shall
      not prejudice the rights or interests of Licensee.
	 	 	  
	14.2	 	 The Licensee shall not other
      than as permitted under the terms of this Agreement grant or purport to
      grant any sub-license or sub-contract of its rights or obligations under
      this Agreement.
	 	 	  
	15	 	 GENERAL
	 	 	  
	15.1	 	 This Agreement together with
      any documents referred to in this Agreement constitute the entire agreement,
      and supersede any previous agreements, between the parties relating to the
      subject matter of this Agreement.
	 	 	  
	15.2	 	 A variation of this Agreement
      is valid only if it is in writing and signed by or on behalf of each party.
	 	 	  
	15.3	 	 The failure to exercise or delay
      in exercising a right or remedy provided by this Agreement or by law does
      not constitute a waiver of the right or remedy or a waiver of other rights
      or remedies. No single or partial exercise of a right or remedy provided
      by this Agreement or by law prevents further exercise of the right or remedy
      or the exercise of another right or remedy.
	 	 	  
	15.4	 	 Except where this Agreement
      provides otherwise the rights and remedies contained in this Agreement are
      cumulative and not exclusive of rights or remedies provided by law.

 

 

13 

	 	 
	15.5	 The parties shall interpret each provision
      of this Agreement, wherever possible, so as to be valid and effective under
      applicable law. Notwithstanding, in the event that a provision (or part
      thereof) of this Agreement is, for any reason, held to be invalid, illegal
      or unenforceable in any respect, that provision (or part thereof) shall
      be ineffective to the extent of such invalidity, illegality or unenforceability
      (as the case may be), but without invalidating the remainder of that provision
      or any other provisions of this Agreement, unless such a construction would
      be unreasonable.
	 	 
	15.6	 This Agreement shall not confer any rights
      or remedies upon any person or entity other than the Licensor and the Licensee,
      and their respective successors and permitted assigns.

	 	 	 
	16	 	 NOTICES

	 	 	 
	16.1	 	 A notice under or in connection
      with this Agreement (a “Notice”):

	 	 	 	 	 
	 	 	 16.1.1	 	shall be in writing;
	 	 	 	 	 
	 	 	 16.1.2	 	shall be in the English language;
      and

	 	 	 
	 	16.1.3	 shall be delivered personally or sent by
      first-class post pre-paid recorded delivery (and air mail if overseas) or
      by fax to the party due to receive the Notice at its address set out in
      this Agreement or to another address or fax number specified by that party
      by not less than seven (7) days’ written notice to the other party
      received before the Notice was dispatched.

	 	 

	 	 
	 	16.2 Unless there is evidence that it was
      received earlier, a Notice is deemed given:
	 	 
	 	16.2.1 if delivered personally, when the person
      delivering the Notice obtains the signature of a person at the address referred
      to in clause 16.1;
	 	 
	 	16.2.2 if sent by post, except air mail, two
      business days after posting it; 
	 	 
	 	16.2.3 if sent by air mail, six business days
      after posting it; and
	 	 
	 	16.2.4 if sent by fax, when confirmation of
      its transmission has been recorded by the sender’s fax machine.

		
	 	In this clause “business day” means a day other
      than a Saturday or Sunday or a public holiday in either the country where
      the Notice is posted or that to which it is sent.

	 	 	 
	17	 	 GOVERNING LAW
	 	 	  
	 	 	 This Agreement and all matters
      arising from or connected with it are governed by the State of Delaware,
      USA, law, without regard to its conflict of law rules.

 

 

14 

	 	 	 
	18	 	 JURISDICTION
	 	 	  
	18.1	 	 The courts of the State of Delaware,
      USA, have exclusive jurisdiction to settle any dispute arising from or connected
      with this Agreement (a “Dispute”).
	 	 	  
	18.2	 	 The parties agree that the courts
      of the State of Delaware, USA, are the most appropriate and convenient courts
      to settle any Dispute and, accordingly that they will not argue to the contrary.

EXECUTED by duly authorized representatives of the parties:

	 	 	 	 	 
	BAXTER VACCINE AG	 	 ACAMBIS INC
	 	 	 	 	 
	By	     	 	By	      
	 	
	 	 	

	Title	     	 	Title 	     
	 	
	 	 	

	Date	     	 	Dateexv4w17

 

EXHIBIT 4.17

Confidential treatment has been requested for certain portions of
this exhibit. The copy filed herewith omits the information subject
to the confidential treatment request. Omissions are designated as
“[*****]” or “*****”. A complete
version of this exhibit has been filed separately with the Commission
pursuant to an application for confidential treatment under
Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended.

                         2000

CONTRACT MANUFACTURING AGREEMENT

between

(1) BAXTER HEALTHCARE CORPORATION

(2) BAXTER HEALTHCARE S.A.

(3) ORAVAX INC.

(4) PEPTIDE THERAPEUTICS GROUP PLC

 

 

TABLE OF CONTENTS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	 	 	 	 	 	 
	 	1	 	 	INTERPRETATION
	 	 	1	 
	 	2	 	 	CANTON FACILITY
	 	 	8	 
	 	3	 	 	CANTON FACILITY EQUIPMENT
	 	 	8	 
	 	4	 	 	CONTRACT MANUFACTURE
	 	 	9	 
	 	5	 	 	FORECASTS AND ORDERS
	 	 	11	 
	 	6	 	 	COSTS
	 	 	13	 
	 	7	 	 	MANUFACTURING FEES
	 	 	14	 
	 	8	 	 	TECHNOLOGY TRANSFER
	 	 	15	 
	 	9	 	 	INTELLECTUAL PROPERTY AND IMPROVEMENTS
	 	 	16	 
	 	10	 	 	LIMITATION OF LIABILITY AND INDEMNITY
	 	 	17	 
	 	11	 	 	ADVERSE DRUG EVENTS AND PRODUCT RECALLS
	 	 	18	 
	 	12	 	 	HEALTH AND SAFETY
	 	 	18	 
	 	13	 	 	NON-SOLICITATION OF EMPLOYEES
	 	 	19	 
	 	14	 	 	COMMENCEMENT AND TERM
	 	 	19	 
	 	15	 	 	TERMINATION
	 	 	19	 
	 	16	 	 	CONSEQUENCES OF TERMINATION
	 	 	20	 
	 	17	 	 	BAXTER’S OPTION TO ACQUIRE THE CANTON FACILITY
	 	 	20	 
	 	18	 	 	CONFIDENTIALITY
	 	 	22	 
	 	19	 	 	ANNOUNCEMENTS
	 	 	23	 
	 	20	 	 	FORCE MAJEURE
	 	 	24	 
	 	21	 	 	ASSIGNMENT AND SUB-CONTRACTING
	 	 	24	 
	 	22	 	 	ENTIRE AGREEMENT
	 	 	24	 
	 	23	 	 	ILLEGALITY AND SEVERANCE
	 	 	25	 
	 	24	 	 	VARIATION
	 	 	25	 
	 	25	 	 	WAIVER
	 	 	25	 
	 	26	 	 	COSTS
	 	 	25	 
	 	27	 	 	RIGHTS OF THIRD PARTIES
	 	 	25	 
	 	28	 	 	COUNTERPARTS
	 	 	25	 
	 	29	 	 	EXCLUSION OF AGENCY, PARTNERSHIP OR JOINT VENTURE
	 	 	25	 
	 	30	 	 	NOTICES
	 	 	26	 
	 	31	 	 	GOVERNING LAW
	 	 	27	 

i

 

TABLE OF CONTENTS

(continued)

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	 	 	 	 	 	 
	 	32	 	 	JURISDICTION
	 	 	27	 
	 	33	 	 	INTEREST TO RUN ON DEFAULT
	 	 	27	 
	 	34	 	 	PARENT COMPANY GUARANTEE
	 	 	27	 
	 	SCHEDULE 1 THE PRODUCTS
	 	 	30	 
	 	SCHEDULE 2 THE PROCESS
	 	 	31	 
	 	SCHEDULE 3 PRODUCT SPECIFICATIONS
	 	 	32	 
	 	SCHEDULE 4 TECHNICAL SCHEDULE
	 	 	33	 
	 	SCHEDULE 5 OPERATING EXPENDITURE
	 	 	34	 
	 	EXHIBIT A
	 	 	35	 

ii

 

THIS AGREEMENT is made on       2000 between the following parties:

	(1)	 	BAXTER HEALTHCARE CORPORATION, a company organised and existing under the
laws of the state of Delaware whose principal place of business is at One
Baxter Parkway, Deerfield, Illinois, 60015-4633, USA; and
	 
	(2)	 	BAXTER HEALTHCARE S.A. a company incorporated in Switzerland (registry of
commerce number CH-170.3.023.618-3) whose registered office is c/o
Reichlin & Hess, Hasenbüelweg 9, 6300 Zug, Switzerland (parties (1) and
(2) together referred to as “Baxter”); and
	 
	(3)	 	ORAVAX INC., a company organised and existing under the laws of the State
of Delaware whose principal place of business is at 38 Sidney Street,
Cambridge, Massachusetts 02139, USA (“Oravax”); and
	 
	(4)	 	PEPTIDE THERAPEUTICS GROUP PLC a company incorporated in England and
Wales (registered number 2863682) whose registered office is at Peterhouse
Technology Park, 100 Fulbourn Road, Cambridge CB1 9PT (“Guarantor”)
(parties (3) and (4) together referred to as “Peptide”).

INTRODUCTION

	(a)	 	Oravax occupies a manufacturing facility in Canton, Massachusetts.
	 
	(b)	 	Baxter is developing a number of vaccines and wishes to appoint Oravax as
its exclusive manufacturer for certain vaccine intermediates.
	 
	(c)	 	Oravax has agreed to modify its manufacturing facility to enable it to
manufacture such vaccine intermediates.

IT IS AGREED as follows:

	1	 	INTERPRETATION
	 
	1.1	 	In this Agreement, (save as otherwise expressly provided in this Agreement):

	 	 	 	 
	 	“Affiliate”	 	
means, in relation to a person, (i) any
corporation or business entity fifty per
cent (50%) or more of the voting stock of
which is and continues to be owned directly
or indirectly by that person; (ii) any
corporation or business entity which
directly or indirectly owns fifty per cent
(50%) or more of the voting stock of that
person; or (iii) any corporation or
business entity under the direct or
indirect control of such corporation or
business entity as described in (i) or
(ii);
	 	 	 	 
	 	“Agency”	 	
means any governmental body responsible for
the licensing of the Products for
commercial sale and the licensing of the
premises and facilities of the Canton
Facility;
	 	 	 	 
	 	“Batch”	 	
means a uniquely identified or identifiable
quantity of Working Seeds, starting
materials,

1

 

	 	 	 	 
	 	 	 	
packaging materials or Product
which has been processed in one process or
series of processes to the extent that such
quantity could be expected to be
homogeneous;
	 	 	 	 
	 	“Baxter Person”	 	
means (i) Baxter, (ii) any member of the
Baxter Group and (iii) any person or
persons with whom Baxter or any member of
the Baxter Group are acting in concert in
relation to Guarantor but (for the
avoidance of doubt) will not include
employees of Baxter Group other than those
with responsibilities in relation to
Baxter’s relationship with Guarantor
pursuant to this Agreement;
	 	 	 	 
	 	“Baxter Requirements Schedule”	 	
means the notification to be given by
Baxter of its requirements for supply of
each of the Products for the period of
twelve (12) calendar months from the date
from which the notification is to apply,
which shall be comprised of a binding Firm
Period and a non-binding Forecast.
	 	 	 	 
	 	“BLA”	 	
means a US Biologic Licence Application;
	 	 	 	 
	 	“Business Day”	 	
means any day other than a Saturday, Sunday
or public holiday in Massachusetts, USA on
which banks are normally open for general
business in Massachusetts, USA;
	 	 	 	 
	 	“Canton Facility”	 	
means the leasehold premises, manufacturing
facility, employees and the business
conducted by Oravax in Canton,
Massachusetts, USA;
	 	 	 	 
	 	“Certificate of Analysis”	 	
means a document signed by a responsible
and appropriate qualified person stating
and confirming that the product to which
such document refers has been Manufactured
in accordance with the Specifications and
GMP or materials to which such document
refers meet the Specifications;
	 	 	 	 
	 	“Certificate of Conformance”	 	
means a document signed by a Qualified
Person stating and confirming that the
Product to which such document refers has
been Manufactured in accordance with the
Specifications and GMP or materials to
which such document refers meet the
Specifications;
	 	 	 	 
	 	“Change of Control”	 	
means the acquisition by any person or
persons (other than a Baxter Person or any
Baxter Persons and any Baxter Persons in a
concert party with non-Baxter Persons shall
be disregarded in determining whether there
has been a Change of Control) who in
relation to each other are acting

2

 

	 	 	 	 
	 	 	 	
in concert of such number of shares in the
Guarantor which, when added to any shares
in the Guarantor already held or controlled
by them, confer in aggregate more than 50%
of the total voting rights conferred by all
the shares in the capital of the Guarantor
for the time being in issue and having the
right to attend and vote at general
meetings of the Guarantor;
	 	 	 	 
	 	“Commissioning”	 	
means the period which commences with
experimental runs and ends on commencement
of Process Development;
	 	 	 	 
	 	“Exhibit A”	 	
sets out the production capacity
requirements of Baxter which may be varied
from time to time by the written agreement
of Baxter and Oravax (such agreement not to
be unreasonably withheld or delayed by
either Baxter or Oravax);
	 	 	 	 
	 	“FDA”	 	
means the Food and Drugs Administration of
the USA;
	 	 	 	 
	 	“Finished Vaccine”	 	
means a vaccine which consists of, or is
made from, a Product and which is capable
of distribution to users;
	 	 	 	 
	 	“Firm Period”	 	
means the binding element of Baxter
Requirements Schedule, being the first four
(4) months thereof;
	 	 	 	 
	 	“Forecast”	 	
means the non-binding element of Baxter
Requirements Schedule, being the last eight
(8) months thereof;
	 	 	 	 
	 	“GAAP”	 	
means generally accepted accounting
principles adopted in the applicable
jurisdictions;
	 	 	 	 
	 	“GMP”	 	
means, as relevant to the Products, the
principles and guidelines of good
manufacturing practice in the USA as set
out in the United States 21 Code of Federal
Regulations Parts 210, 211 and 600 as
amended or extended from time to time and
the corresponding regulations of the
Pharmaceutical Inspection Convention and in
the European Union as set out in EC
Directive 91/356/EEC (medicinal products
for human use), as such principles and
guidelines are interpreted and expanded in
“The Rules Governing Medicinal Products in
the European Community, Volume IV. Good
Manufacturing Practice for Medicinal
Products”, together with those rules and
guidelines contained in the Orange Book;

3

 

	 	 	 	 
	 	“Group”	 	
means, in relation to a Party, that Party
and any Affiliate from time to time of that
Party;
	 	 	 	 
	 	“Group Company”	 	
means any member of the Group;
	 	 	 	 
	 	“Intellectual Property”	 	
means Patents, trademarks, service marks,
registered designs, applications and rights
to apply for registration of any of the
foregoing and the right to apply for them
in any part of the world, trade and
business names (including internet domain
names and e-mail address names),
unregistered trademarks and service marks,
copyrights, database rights, know-how
(including, without limitation, that
comprised in or derived from drawings,
data, formulae, specifications, component
lists, instructions, manuals, brochures,
catalogues and process descriptions, rights
in designs and inventions);
	 	 	 	 
	 	“Intellectual Property Rights”	 	
means all Intellectual Property owned,
controlled, used or required to be used by
a Party;
	 	 	 	 
	 	“Manufacture”	 	
means the production of the Products from
the Working Seeds and shall, where
relevant, include manufacturing,
formulating, assembling, packaging,
storage, handling, testing and quality
control and “Manufactured” and
“Manufacturer” shall be interpreted
accordingly;
	 	 	 	 
	 	“Manufacturing Fees”	 	
means the fees set out in Clause 7;
	 	 	 	 
	 	“Manufacturing Records”	 	
means manufacturing, facility/systems and
environmental monitoring and cleaning,
packaging and quality control and quality
assurance records generated by Oravax in
the course of the Manufacture of the
Products;
	 	 	 	 
	 	“Marketing Authorisation”	 	
means authorisation to market a Product in
a particular jurisdiction including any
Regulatory Approval and approvals of price
where controls on price exist;
	 	 	 	 
	 	“Master Cell Bank”	 	
means the divided culture owned by Baxter
which is laid down and maintained for the
life of the Product and from which the
Working Seed shall be derived;
	 	 	 	 
	 	“Net Average Selling Price”	 	
means the net average selling price in any
given quarter of a Finished Vaccine sold by
Baxter (being the gross invoice price less
sales taxes, duties, delivery charges and
returns over the relevant quarter);

4

 

	 	 	 	 
	 	“Operating Expenditure”	 	
means the cost of operating the Canton
Facility as set out in Schedule 5;
	 	 	 	 
	 	“Orange Book”	 	
means the publication “Rules and Guidance
for Pharmaceutical Manufacturers and
Distributors 1997” published by the
Medicines Control Agency as such
publication may be amended or reissued from
time to time;
	 	 	 	 
	 	“Parent Company Guarantee”	 	
means the guarantee given to Baxter by the
Guarantor in Clause 34;
	 	 	 	 
	 	“Party”	 	
means a party to this Agreement and shall
include its successors in title, permitted
assignees and permitted transferees;
	 	 	 	 
	 	“Patent”	 	
shall mean (a) patent applications
heretofore or hereafter filed or having
legal force in any country, together with
any and all patents that have issued or in
the future shall issue therefrom, including
utility patents, utility models, petty
patents, design patents and certificates of
invention, and (b) all divisionals,
continuations, continuations-in-part,
reissues, renewals, extensions or additions
to any such patents and patent
applications, as well as all foreign
counterparts of such patents and patent
applications, to the extent that (a) and
(b) relate to any Products or the
Manufacture of any Products, which Baxter
and/or Oravax own(s) or in which Baxter
and/or Oravax has or have a transferable
interest;
	 	 	 	 
	 	“Process”	 	
means the process to be used to Manufacture
the Products as set out in Schedule 2 and
as modified from time to time with the
prior written agreement of Baxter and
Oravax;
	 	 	 	 
	 	“Process Development”	 	
means the period commencing with a
processing run using the Working Seed and
ending on Validation;
	 	 	 	 
	 	“Process Improvements”	 	
means all improvements, modifications or
adaptations to any process employed by
Oravax and at any time during the
continuance of this Agreement used in the
conduct of Manufacture, and not
specifically nor exclusively capable of
employment in the Manufacture of the
Products;
	 	 	 	 
	 	“Products”	 	
means the products specified and described
in Schedule 1;

5

 

	 	 	 	 
	 	“Product Licence”	 	
means the licence issued by the FDA or any
other Agency for a Product pursuant to
obtaining approval from the FDA or any
other Agency that such Product meets the
required standards and regulations
applicable to marketed products;
	 	 	 	 
	 	“Qualified Person”	 	
means the US equivalent of the person so
designated in accordance with EC Directive
75/319;
	 	 	 	 
	 	“Regulation”	 	
means any regulation, rule, official
directive, request or guideline (whether or
not having the force of law) of any
governmental, intergovernmental or
supranational body, agency, department or
regulatory, self-regulatory or other
authority or organisation;
	 	 	 	 
	 	“Regulatory Approval”	 	
means any Product Licence, marketing
authorisation or clinical trials
certificate issued by the relevant Agency
permitting, as appropriate, the
importation, distribution, sale, marketing
or use of the Products;
	 	 	 	 
	 	“Special Order Equipment”	 	
means any plant and equipment which is
required at the Canton Facility to
Manufacture the Products (other than plant
and equipment which is or may be used to
Manufacture other products) and any spares
and replacement parts for such plant and
equipment;
	 	 	 	 
	 	“Specifications”	 	
means the specifications for the Products
as set out in Schedule 3;
	 	 	 	 
	 	“Tax” or “Taxation”	 	
means all forms of taxation and statutory,
governmental and state duties, imposts,
contributions, levies and charges, whether
of the USA, the UK or elsewhere, including,
but without limitation, corporate tax,
dividend withholding tax, interest
withholding tax, individual income tax,
wealth tax, inheritance and gift taxes,
value-added tax and excise taxes, transfer
and stamp tax and local taxes and any
interest, penalty surcharge or fine in
connection with it;
	 	 	 	 
	 	“Tax Authority”	 	
means any local, provincial, municipal,
governmental, state federal or other fiscal
revenue authority, body or official
competent to impose, administer or collect
Tax;
	 	 	 	 
	 	“Technical Information”	 	
means all know-how, registration data,
experience, instructions, standards,
methods, test and trial results,
manufacturing processes, hazard
assessments, quality control standards
formulae,

6

 

	 	 	 	 
	 	 	 	
specifications, storage data,
samples, drawings, designs, descriptions of
packaging materials and all other relevant
information relating to the Products or the
design, Manufacture, storage or use of the
Products;
	 	 	 	 
	 	“US$”	 	
means the lawful currency of the United
States of America;
	 	 	 	 
	 	“Validation”	 	
means the process of proving, in accordance
with the principles of GMP, the
reproducibility, efficacy, and
repeatability of any procedure, process,
equipment, material, testing equipment,
tests, activity or system and the ability
thereof to achieve the result which is
intended to be achieved;
	 	 	 	 
	 	“Warning Letter”	 	
means a warning letter issued under the
United States 21 Code of Federal
Regulations; and
	 	 	 	 
	 	“Working Seeds”	 	
means the bacterial seeds manufactured by
Baxter from which the Products are to be
Manufactured by Oravax.

	1.2	 	In this Agreement:

	 	1.2.1	 	references to a “person” include an individual, corporation
(wherever incorporated), unincorporated association, trust or
partnership (whether or not having separate legal personality),
government, state or agency of a state, or two or more of the
foregoing;
	 
	 	1.2.2	 	references to a document in the “agreed form” are to that
document in the form agreed to and initialled for the purposes of
identification by or on behalf of the Parties;
	 
	 	1.2.3	 	references to a clause, schedule or appendix are to a
clause, schedule or appendix of this Agreement, and references to
this Agreement include the schedules and the appendices;
	 
	 	1.2.4	 	the headings in this Agreement do not affect its
construction or interpretation;
	 
	 	1.2.5	 	references to a statute or a statutory provision are to such
statute or statutory provision as amended or re-enacted whether
before or after the date of this Agreement and include all
subordinate legislation made under the relevant statute whether
before or after the date of this Agreement;
	 
	 	1.2.6	 	a reference to a document is a reference to that document as
amended or modified from time to time in writing by the mutual
consent of the Parties;
	 
	 	1.2.7	 	references to writing shall be deemed to include any modes
of reproducing words in a legible or non-transitory form;

7

 

	 	1.2.8	 	the singular includes the plural and vice versa and any
gender includes any other gender;
	 
	 	1.2.9	 	the “winding-up”, “dissolution” or “administration” of a
company or corporation shall be construed so as to include any
equivalent or analogous proceedings under the law of the
jurisdiction in which such company or corporation is incorporated or
any jurisdiction in which such company or corporation carries on
business, including proceedings whereby liquidation, winding-up,
reorganisation, dissolution, administration, arrangement,
adjustment, protection or debtor’s relief is sought.

	2	 	CANTON FACILITY
	 
	2.1	 	Oravax shall use all commercially reasonable efforts to procure the
completion of the design and construction of a manufacturing facility at
Canton, Massachusetts, USA within eighteen (18) months of the date of this
Agreement in order, among other things, to Manufacture the Products for
Baxter with capacity to meet Baxter’s requirements set out in Exhibit A.
The Canton Facility shall comply in all respects with GMP. For the
avoidance of doubt, the time period referred to in this Clause 2.1 does
not refer to Commissioning, Process Development or Manufacture of the
Products.
	 
	2.2	 	Oravax shall have responsibility for the design, procurement and
construction of the Canton Facility. Baxter and Oravax shall appoint a
committee with representatives from both Baxter and Oravax (the “Steering
Committee”) whose function shall be to oversee and monitor the design,
procurement, construction and operation of the Canton Facility. The
Steering Committee shall subsist for the duration of this Agreement and
shall meet from time to time. Oravax shall disclose any plans and
relevant information for the design, procurement and construction of the
Canton Facility to the Steering Committee. Baxter may make any comments
or suggestions regarding the design, construction and operation of the
Canton Facility to the Steering Committee. The Steering Committee shall
discuss any information submitted to it by Baxter or Oravax and report its
discussions from time to time to Baxter and Oravax. Oravax shall
consider, but shall not be obliged to accept, any comments or suggestions
of the Steering Committee.
	 
	2.3	 	For three (3) years from the date of this Agreement, Oravax shall not use
the Canton Facility to manufacture products for any third party but, for
the avoidance of doubt, may manufacture products for its own internal use
or exploitation. Such manufacture of products for Oravax’s own use or
exploitation shall not interfere with, or prevent in any way, the
Manufacture of the Products by Oravax for Baxter.
	 
	2.4	 	Oravax shall carry out such environmental monitoring as required by any
applicable law or regulation or guidance from the FDA from time to time.
	 
	3	 	CANTON FACILITY EQUIPMENT
	 
	3.1	 	The Parties anticipate that in order to Manufacture the Products at the
Canton Facility certain Special Order Equipment may be required. Prior to
the purchase of any Special Order Equipment, Oravax shall notify Baxter in
writing of the requirement and the reasons therefor and Oravax shall
obtain the prior written approval of Baxter on the choice of such Special
Order Equipment.
	 
	3.2	 	Baxter shall pay to Oravax an amount equal to the cost of the Special
Order Equipment secured against such Special Order Equipment.

8

 

	3.3	 	Oravax shall invoice Baxter in respect of the cost of the Special Order
Equipment at the time such Special Order Equipment is purchased by Oravax
and at the same time provide to Baxter a copy of any invoice supplied by
the seller of the Special Order Equipment and Oravax’s invoice shall be
paid within thirty (30) days of receipt of invoice.
	 
	3.4	 	On termination of this Agreement, Baxter shall have the option,
exercisable within thirty (30) days of the date of termination, to notify
Oravax in writing that it wishes to purchase any or all Special Order
Equipment from the Canton Facility for the sum of one US Dollar (US$1).
On receipt of such notice, Oravax shall promptly make such Special Order
Equipment available for collection by Baxter. The reasonable cost of
removing such Special Order Equipment and making good any damage caused on
removal shall be borne by Baxter. Oravax shall invoice Baxter for such
costs and such invoice shall be paid within thirty (30) days of receipt.
	 
	4	 	CONTRACT MANUFACTURE
	 
	4.1	 	Subject to Clause 4.2, Baxter hereby exclusively appoints Oravax to
Manufacture Baxter’s and all members of its Group’s requirements for the
Products and Oravax accepts such appointment. During the term of this
Agreement, Oravax will Manufacture for Baxter’s Group the Products in
accordance with this Agreement and Baxter shall and shall procure that
Baxter’s Group:

	 	4.1.1	 	acquire all their requirements for the Products exclusively
from Oravax; and
	 
	 	4.1.2	 	do not themselves Manufacture or have Manufactured the
Products other than as set out in this Agreement.

	4.2	 	Oravax’s exclusivity as set out in Clause 4.1 shall not apply in the
circumstances set out in Clause 20.3 or in relation to a particular
Product that Oravax is unable to Manufacture within twelve (12) months of
the date of commencement of Process Development for that particular
Product.
	 
	4.3	 	Oravax shall:

	 	4.3.1	 	supply all information to and otherwise cooperate with
Baxter, as reasonably required by Baxter, to maximise the likelihood
of Baxter’s success in obtaining a BLA including but not limited to
the FDA’s pre-approval inspection of the Canton Facility;
	 
	 	4.3.2	 	Manufacture the Products using the Process in accordance
with the Specifications;
	 
	 	4.3.3	 	ensure that any materials employed by Oravax in the
Manufacture and not supplied by or on behalf of Baxter will at the
time of use comply with the Specifications;
	 
	 	4.3.4	 	allow, once in every three (3) months during the period of
this Agreement or at such other times to satisfy the Agency and
during normal business hours and upon reasonable notice, authorised
representatives of Baxter reasonably acceptable to Oravax to inspect
the relevant parts of its premises where the Manufacture of the
Products is carried out or the Products or Working Seeds are stored,
to inspect the process of Manufacture, and to inspect any
documentation relating to compliance with GMP or to the safety,
purity or

9

 

	 	 	 	potency of the Product. The costs of such inspection shall be
payable by Baxter. Notwithstanding the foregoing, Oravax’s
obligation to allow such visitors is on condition that: (a)
Baxter procures that such visitors agree in writing to observe
the requirements of Oravax regarding security, health and
safety, confidentiality or any other applicable regulations at
the relevant premises; (b) any visit shall be under the
specific supervision of Oravax (without relieving any visitors
of any obligations with respect to any damage or injury caused
by them); (c) Baxter indemnifies and shall keep indemnified
Oravax against any damage to Oravax’s property or any personal
injury which is caused by any act or omission of any of Baxter’s
employees or authorised agents or nominated visitors on Oravax’s
premises; and (d) Baxter uses its reasonable endeavours to
ensure that any visit is of minimal disruption to Oravax’s day
to day business;
	 
	 	4.3.5	 	allow representatives of any Agency to inspect the relevant
parts of its premises where the Manufacture of the Products is
carried out and to inspect the Manufacturing Records to ensure
compliance with GMP and other practices or regulations. Oravax
shall immediately inform Baxter of the commencement of any Agency
inspections and any questions or recommendations made by the Agency
and shall provide to Baxter copies of any written questions,
recommendations or any other material correspondence or
documentation (including, without limitation, FD483 or Warning
Letters) received from the Agency insofar as they pertain to the
Manufacture of the Products;
	 
	 	4.3.6	 	upon written request and at the cost of Baxter and within
fourteen (14) Business Days of receipt of such request supply Baxter
with reasonable quantities of samples of the Products Manufactured
by it provided that no Manufacture is required primarily for the
purpose of providing Baxter with the said samples. Oravax shall
retain a quantity of samples of each production Batch of the
Products equal to twice the amount reasonably required to conduct
relevant analysis;
	 
	 	4.3.7	 	retain for a minimum of three (3) years manufacturing,
analytical and distribution records and shall retain such samples of
the products as are required by, and in the manner and for the
duration specified by, GMP. During the said three (3) year period,
it shall make such records promptly available to Baxter upon
reasonable notice. Upon Oravax deciding to dispose of such records
or samples, Oravax shall notify Baxter of such decision taken by
Oravax. In the absence of any response from Baxter within three (3)
months of notification, Oravax may destroy or otherwise dispose of
the said records or such samples as it sees fit;
	 
	 	4.3.8	 	upon request, supply to Baxter the facility floor plan,
equipment and process Validation documentation and any other
information or documentation relating to the safety, purity or
potency of the Product;
	 
	 	4.3.9	 	at all times comply with GMP; and
	 
	 	4.3.10	 	as required, register as a manufacturer with the FDA and with any
other Agency in territories where Baxter distributes the Product.

10

 

	4.4	 	Baxter shall:

	 	4.4.1	 	supply to Oravax a sufficient quantity of Working Seeds in
time to enable Oravax to Manufacture Products in accordance with the
Baxter Requirements Schedule from time to time;
	 
	 	4.4.2	 	file the BLA in its own name and, for such purpose, Oravax
will submit to Baxter in a timely fashion data and information
relating to the Manufacture of the Products for inclusion by Baxter
in the BLA as requested by Baxter from time to time. Oravax shall
provide Baxter with a reasonable opportunity to review any changes
to the Process in order that the BLA may be amended in accordance
with any Regulation or law;
	 
	 	4.4.3	 	obtain and maintain throughout the term of this Agreement
appropriate Regulatory Approvals for the Products and for any other
jurisdiction or territory for which the Products are being
Manufactured or in which the Products are to be marketed,
distributed, sold or used;
	 
	 	4.4.4	 	ensure that any Working Seeds and other products to be
provided by it shall comply with the Specifications and where
appropriate shall be accompanied by a Certificate of Conformance
from Baxter;
	 
	 	4.4.5	 	ensure that it has notified Oravax of any special
requirements in respect of record-keeping that may be necessary to
comply with Baxter’s adverse event/defect/recall procedure; and
	 
	 	4.4.6	 	notify Oravax of any hazards to the health or safety of any
personnel of Oravax or the possibility of cross contamination of any
other products being manufactured or stored by Oravax and Baxter
shall keep Oravax so advised throughout the continuance of this
Agreement, whether such hazards or possibilities are inherent in the
Product or otherwise.

	4.5	 	Baxter warrants that:

	 	4.5.1	 	it has the Master Cell Bank for each Product and shall
maintain those for the term of this Agreement; and
	 
	 	4.5.2	 	the Master Cell Bank shall comply with current GMP rules and
regulations and be fit for the purposes of this Agreement.

	4.6	 	Any alteration or amendment to the indications or presentations of the
Product shall be subject to the prior written agreement of Baxter and
Oravax and shall be deemed an alteration to this Agreement.
	 
	4.7	 	Manufacture, testing and release of the Products shall be carried out in
the manner set out in the Technical Schedule shown in Schedule 4 which is
hereby incorporated herein.
	 
	5	 	FORECASTS AND ORDERS
	 
	5.1	 	During the term of this Agreement, Baxter will submit to Oravax, the
Baxter Requirements Schedules including any Product required by Baxter to
carry out clinical trials. The first Baxter Requirements Schedule shall
be submitted to Oravax twelve (12) calendar months before Baxter
anticipates requiring the Manufacture of Products and

11

 

	 	 	shall cover twelve (12) calendar months. Thereafter Baxter Requirements
Schedules will be submitted each month by no later than the tenth (10th)
day of each calendar month, specifying Baxter’s anticipated requirements
for each Product in calendar monthly periods for the relevant twelve (12)
month period covered by Baxter Requirements Schedule.
	 
	5.2	 	The first Baxter Requirements Schedule submitted to Oravax shall be
accompanied by purchase orders covering the Firm Period of such Baxter
Requirements Schedule. All subsequent Baxter Requirements Schedules
submitted shall be accompanied by purchase orders covering the relevant
amount of each Product indicated as being required in the last month of
the Firm Period.
	 
	5.3	 	Other than during the first four (4) months of the first Baxter
Requirements Schedule for which Baxter and Oravax shall take Exhibit A
into consideration, Oravax shall accept any purchase order received by
Baxter which is in accordance with the Baxter Requirements Schedule and
Oravax shall deliver such Product as soon as is reasonably practicable to
Baxter (“Delivery Date”). Oravax shall deliver such Product no later than
fourteen (14) days after the Delivery Date.
	 
	5.4	 	No purchase order shall request supply of Product in respect of the last
month of that Firm Period in a quantity which differs by more than twenty
per cent (20%) from the quantity specified for the first month of the
Forecast contained in the immediately preceding Baxter Requirements
Schedule.
	 
	5.5	 	If so requested, Oravax will use reasonable efforts, but with no
obligation in respect of the quantity thereof, to supply to Baxter
additional Products in excess of that ordered or contained in the relevant
Baxter Requirements Schedule in accordance with this Clause 5 having due
regard to Oravax’s production capacity and other manufacturing
commitments.
	 
	5.6	 	Oravax shall be entitled to treat the Firm Period as a binding order of
Baxter and to purchase raw materials and to allocate production capacity
accordingly. In the event that any raw materials have a lead time of
longer duration than the Firm Period, then Oravax shall, for the purposes
of purchasing such raw materials and allocating production capacity, be
entitled to treat the Forecast as a binding order to the extent necessary
to coincide with the said lead times.
	 
	5.7	 	The Products are supplied by Oravax DDU as such term is defined in
INCOTERMS 2000 and Oravax shall supply those documents specified in
Schedule 4 with each Batch of Product. Risk in the Products shall pass to
Baxter on delivery. Notwithstanding the passing of risk, title to each
Batch of the Product shall be and remain with Oravax unless and until
Baxter has paid in full for that Batch of Product supplied hereunder.
	 
	5.8	 	Baxter shall inspect and/or test Products as soon as practicable
following delivery. Failure by Oravax to Manufacture the Products in
accordance with Specifications or delivery by Oravax more than ninety (90)
days after the stipulated delivery date shall be the only reasons for
which Baxter may reject the Products. If Baxter wishes to reject any
delivery of Product it must notify Oravax within thirty (30) days of
receipt of the Product and such notification must be in writing and
include a detailed indication of the reasons for rejection. Baxter shall
be deemed to have accepted the Product and shall not be entitled to reject
the same unless it provides such written notification within the said
period of thirty (30) days. Oravax shall notify Baxter within thirty (30)
days of receipt of such notification of rejection whether it accepts
Baxter’s claim. If Oravax does not

12

 

	 	 	accept that it has failed to Manufacture the Products in accordance with
the Specifications or Baxter disagrees then an independent laboratory
mutually agreed by Baxter and Oravax shall be requested to analyse an
appropriate amount of the Product from the Batch or Batches in dispute.
The independent laboratory shall act as expert not arbitrator and the
cost of its analysis shall be paid by the Party against whom the
laboratory findings were made. Two samples shall be supplied by Baxter
from the Batches in question and by Oravax from any samples that it has
retained. The results of the said analysis shall be binding on Baxter
and Oravax, but upon receipt thereof Baxter and Oravax shall meet to
discuss in good faith the failure of the Batch in question and the
resolution of the dispute between them.
	 
	5.9	 	If a Product does not conform to the Specifications due to the negligence
or default of Oravax then Oravax shall Manufacture and deliver to Baxter a
sufficient quantity of the Product to replace the defective Batch or
Batches. If Baxter accepts that the relevant Batches of Product were
Manufactured in accordance with the Specifications or that any defect did
not arise due to Oravax’s negligence or default Oravax shall have no
liability or obligations to Baxter in respect of such Batches. Should
Baxter and Oravax fail to agree with respect to the conformity of the
Product to the Specifications and the cause thereof, either of them may
pursue resolution of the dispute through the forum specified in Clause 32.
	 
	5.10	 	If, in any calendar year of this Agreement beginning 2005, the
Manufacturing Fees received by Oravax are less than the sum of (total
[ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * *
]) (together the “Minimum Payment”), Oravax shall invoice Baxter for the
amount of the difference between the amount of the Manufacturing Fees for
that calendar year and the Minimum Payment and Baxter shall pay to Oravax
the amount of such difference within thirty (30) days of receipt of such
notice.
	 
	6	 	COSTS
	 
	6.1	 	Commissioning
	 
	 	 	Baxter shall pay to Oravax for the period of Commissioning an amount
equal to one half times its Operating Expenditure for the Canton Facility
during such period, subject to a maximum of two million US Dollars
(US$2,000,000). No Operating Expenditure relating to Commissioning shall
be charged back to Baxter (including by way of depreciation) in any form
whatsoever pursuant to this Clause 6.
	 
	6.2	 	Process Development
	 
	 	 	Baxter shall pay to Oravax for the period after Commissioning during
Process Development an amount equal to its Operating Expenditure for the
Canton Facility. The total cost to be borne by Baxter under this Clause
6.2 shall not exceed seven million US Dollars (US$7 million).
	 
	6.3	 	Oravax shall invoice Baxter in respect of the costs referred to in
Clauses 6.1 and 6.2 monthly in arrears and such invoices shall be paid
within thirty (30) days of receipt.
	 
	6.4	 	Baxter may, at its cost, engage a mutually acceptable independent
accounting firm to confirm that all invoices submitted by Oravax pursuant
to Clauses 6.1 and 6.2 have been correctly based on actual Operating
Expenditure of the Canton Facility. Oravax shall provide all reasonable
assistance and access to the relevant financial records to such
independent accounting firm for the purposes of such exercise. In the
event that Baxter and Oravax agree to engage an independent accounting
firm but are unable to agree the

13

 

	 	 	identity of such firm, or the firm agreed
upon is unable or unwilling to act, either
Baxter or Oravax may apply to the President
of the US Institute of Public Accountants
for the appointment by him of such an
independent accounting firm.
	 
	7	 	MANUFACTURING FEES
	 
	7.1	 	In consideration for the services provided to Baxter under this
Agreement, Baxter shall pay to Oravax the following Manufacturing Fees:

	 	7.1.1	 	[ * * * * ]; and
	 
	 	7.1.2	 	a royalty calculated as follows:

	 	(a)	 	in the case of a monovalent vaccine, a
royalty of [ * * * * ]; and
	 
	 	(b)	 	in the case of a multivalent vaccine, a
royalty of [ * * * * ],

	 	 	 	in each case sold or otherwise disposed of by Baxter.
	 
	 	 	 	For the purposes of this clause, “component proportion” means:

	 	(i)	 	[ * * * * ]; and
	 
	 	(ii)	 	[ * * * * ].

	 	 	 	Worked example of (i)
	 
	 	 	 	[ * * * * ]
	 
	 	 	 	Worked example of (ii)
	 
	 	 	 	[ * * * * ]

	 	7.1.3	 	in the case of Product produced to support clinical trials,
no fee under Clause 7.1.2 shall be charged.

	7.2	 	Oravax shall invoice Baxter in respect of the Manufacturing Fees referred
to in Clause 7.1 monthly in arrears and such invoices shall be paid within
thirty (30) days of receipt of invoice.
	 
	7.3	 	Baxter shall within twenty (20) days of the end of each calendar quarter
notify Oravax in writing of the aggregate value in US$ of the Net Average
Selling Price of Products sold by Baxter during the immediately preceding
calendar quarter and the amount of Manufacturing Fees to which Oravax is
entitled pursuant to Clause 7.1.2. Oravax shall invoice Baxter in respect
of such Manufacturing Fees, which invoices shall be paid by Baxter within
ten (10) days of receipt of invoice.
	 
	7.4	 	In calculating the aggregate value of Baxter’s Net Average Selling Price
for sales of Products for the purposes of Clause 7.3, any sales of
Products to an Affiliate of Baxter shall be deemed to be the Net Average
Selling Price of the Affiliate’s sales to its customers.
	 
	7.5	 	Oravax may, at its cost, engage a mutually acceptable independent
accounting firm to confirm that the aggregate value of the Net Average
Selling Price for Products notified by Baxter to Oravax pursuant to Clause
7.1.2 has been correctly calculated. Baxter shall

14

 

	 	 	provide all reasonable assistance and access to the relevant financial
records to such independent accounting firm for the purposes of such
exercise. In the event that Baxter and Oravax agree to engage an
independent accounting firm but are unable to agree the identity of such
firm, or the firm agreed upon is unable or unwilling to act, either
Baxter or Oravax may apply to the President of the US Institute of Public
Accounts for the appointment by him of such an independent accounting
firm.
	 
	7.6	 	Any underpayment or overpayment identified by the such independent public
auditor shall be repaid or paid (as appropriate) within thirty (30) days
of being determined.
	 
	8	 	TECHNOLOGY TRANSFER
	 
	8.1	 	Oravax’s obligations to begin Process Development and Manufacture of the
Products shall be conditional upon:

	 	8.1.1	 	Baxter supplying to Oravax all Technical Information which
is relevant and desirable and which will enable Oravax to carry out
Process Development and Manufacture; and
	 
	 	8.1.2	 	Baxter confirming in writing, in respect of each Product,
that it has produced the Product in accordance with the relevant
Specifications in a quantity of at least ten per cent (10%) of the
commercial production quantity at the Canton Facility as specified
in Exhibit A.

	8.2	 	Baxter will provide such technical assistance at its own cost as may be
required to enable the effective transfer of the Technical Information
referred to in Clause 8.1 such that Oravax should reasonably be expected
to be able to carry out Process Development and Manufacture of the
Products on the basis of such Technical Information.
	 
	8.3	 	Upon receipt of such Technical Information and technical assistance,
Oravax shall carry out Validation of the process of Manufacture in
accordance with a protocol to be agreed by Baxter and Oravax. Should
Validation of the process of Manufacture not be proven, then the
provisions of Clause 8.5 shall apply.
	 
	8.4	 	Upon Validation of the process of Manufacture, Oravax shall Manufacture
for production testing a minimum of three (3) consecutive Validation
Batches of the Product within nine (9) months of the Validation in
accordance with the Specifications. Should Oravax be unable for whatever
reason to Manufacture the Product in accordance with the Specifications,
then the provisions of Clause 8.5 shall apply.
	 
	8.5	 	Notwithstanding anything else herein contained, should Validation of the
process of Manufacture in respect of a Product not be proven or should
Oravax be unable for technical reasons (having used all commercially
reasonable efforts to overcome such technical reasons) or reasons outside
its control to Manufacture such Product in accordance with the
Specifications, then in any such event Oravax may terminate this Agreement
in respect of that Product by written notice to Baxter, and Baxter’s and
Oravax’s obligations hereunder shall be at an end, save for those
obligations which shall survive termination either by reason of the nature
of the obligations or by express agreement of Baxter and Oravax. In any
event, Baxter shall remain liable to Oravax for services rendered or
products supplied and any costs incurred by Oravax prior to the date of
termination.

15

 

	9	 	INTELLECTUAL PROPERTY AND IMPROVEMENTS
	 
	9.1	 	Baxter hereby authorises Oravax to use Baxter’s intellectual property
(excluding trade marks) on or in relation to the Products for the purpose
only of exercising its rights and performing its obligations under this
Agreement.
	 
	9.2	 	Baxter and Oravax hereby acknowledge that neither of them shall acquire
any rights in respect of the others intellectual property in relation to
the Products or the Manufacture thereof or of the goodwill associated
therewith.
	 
	9.3	 	Except as is necessary for the proper performance of this Agreement by
Baxter and Oravax, no licence, express or implied, is granted by this
Agreement by either of Baxter or Oravax to the other under any of its
intellectual property rights.
	 
	9.4	 	All Intellectual Property Rights and Process Improvements generated from
the process and development of the Products at the Canton Facility shall
be jointly owned by Baxter and Oravax (save in respect of claims of
compositions of matter which shall be the exclusive property of Baxter).
Notwithstanding joint ownership of such Intellectual Property Rights and
Process Improvements, for three (3) years from the date of this Agreement,
Oravax will not use licence or exploit such Intellectual Property Rights
and Process Improvements except for the Manufacture of the Products. For
the avoidance of doubt, except as provided in Clause 9.6, after three (3)
years from the date of this Agreement, both Oravax and Baxter are free to
use, licence and otherwise exploit such Intellectual Property Rights and
Process Improvements without restriction but Oravax and Baxter (as the
case may be) shall have a right of first offer on terms not less
favourable than those subsequently offered to any third party in respect
of any transfer or disposal of such Intellectual Property Rights and
Process Improvements. If either Baxter or Oravax (as the case may be) do
not accept such offer, then any third party to whom such Intellectual
Property Rights and Process Improvements are subsequently offered shall be
informed by Baxter or Oravax (as the case may be) that such Intellectual
Property Rights and Process Improvements are jointly owned with Baxter or
Oravax (as the case may be).
	 
	9.5	 	Baxter shall at its cost be responsible for prosecuting and maintaining
registration in respect of the Intellectual Property Rights referred to in
Clause 9.4 in the appropriate jurisdictions. Baxter shall inform Oravax
of any such prosecution and/or maintenance of the registration and shall
keep, and supply to Oravax, any substantive communications in respect
thereof. In the event that Baxter decides not to prosecute and/or
maintain any such registration, Oravax may assume Baxter’s rights and
obligations in respect thereof at Oravax’s cost.
	 
	9.6	 	All Intellectual Property Rights generated from process and development
of the Products at the Canton Facility shall not be used, licensed or
exploited by Oravax for a period of five (5) years from the date of
termination of this Agreement in respect of products using the same
carrier proteins for use in a vaccine for the same indication as the
Products.
	 
	9.7	 	Title to and property in all Manufacturing Records (as defined below)
generated by Oravax shall be and remain at all times exclusively vested in
Oravax, and Baxter hereby disclaims any right thereto.
	 
	9.8	 	The Manufacturing Records (which shall include but not be limited to all
Batch documentation and Validation data) shall be treated as information
of Oravax and Baxter may have access to such information but such
information shall not be used or disclosed by Baxter other than for the
purposes of this Agreement and where necessary for

16

 

	 	 	disclosing to the relevant regulatory authorities in order to comply with
regulatory requirements relating to the Products and their Manufacture by
Oravax.
	 
	9.9	 	No Process Improvements shall be employed by Oravax in the Manufacture of
the Products unless the terms upon which such Process Improvements are to
be employed by Oravax have been agreed.
	 
	10	 	LIMITATION OF LIABILITY AND INDEMNITY
	 
	10.1	 	Without prejudice to Oravax’s obligations under this Agreement, all
warranties and conditions in respect of the Product, whether express or
implied, by statute, common law or otherwise, are hereby excluded to the
fullest extent permissible by law.
	 
	10.2	 	Oravax shall indemnify Baxter against any legal liability to third
parties in respect of all claims, actions, judgments, damages, lawsuits,
costs or expenses or professional fees for death or personal injury
incurred by Baxter in relation to or arising solely out of any breach of
contract by Oravax or any negligent act or omission of Oravax, or its
employees in the course of their employment. Any and all liability of
Oravax to Baxter howsoever arising in respect of this Agreement and its
performance shall be limited (except for fraud or death or personal injury
caused by the negligence of Oravax or its employees while acting in the
course of their employment) to an amount equal to the amount received by
Oravax from Baxter under this Agreement for the twelve (12) calendar month
period immediately preceding the occurrence giving rise to such loss or
damage (excluding any taxes).
	 
	10.3	 	Baxter shall indemnify Oravax against all claims, actions, judgments,
damages, lawsuits, costs or expenses or professional fees incurred by
Oravax in relation to or arising out of any breach of contract by Baxter
or any act or omission of Baxter its employees or agents and in additional
against any and all damage arising through the storage, distribution,
promotion, marketing sale or use (whether or not in accordance with the
indications) of Products by the Baxter Group hereunder. Any and all
liability of Baxter to Oravax howsoever arising in respect of this
Agreement and its performance shall be limited (except for fraud or death
or personal injury caused by the negligence of Baxter or its employees,
agents or sub-contractors while acting in the course of their employment)
to an amount equal to the amount received by Oravax from Baxter under this
Agreement for the twelve (12) calendar month period immediately preceding
the occurrence giving rise to such loss or damage (excluding any taxes).
	 
	10.4	 	Baxter and Oravax agree that neither of them will be liable whether for
breach of contract, misrepresentation, negligence or otherwise, for loss
of profit, indirect or consequential loss, damage or liability suffered by
the other, including without limitation, goodwill, business opportunity or
anticipated saving.
	 
	10.5	 	Nothing in this Agreement shall operate to exclude or restrict Baxter’s
or Oravax’s liability for:

	 	10.5.1	 	death or personal injury caused by negligence; or
	 
	 	10.5.2	 	fraud.

	10.6	 	The Party claiming the benefit of any indemnity hereunder must promptly
notify the other of any claim, not accept any compromise or settlement of
such claim or take any material

17

 

	 	 	steps in relation to such claim without the prior consent of the other
Party and shall co-operate fully with the other Party in the handling of
any such claim.
	 
	10.7	 	Any Working Seeds supplied by Baxter shall be and at all times remain at
the risk of Baxter, and Baxter shall insure such Working Seeds to their
full replacement value while on Oravax’s premises unless and until they
are incorporated into Products.
	 
	10.8	 	Baxter undertakes to ensure that it has in place product liability
insurance with a reputable insurer in an amount appropriate for its
business and products of the type the subject of this Agreement, and for
its obligations under this Agreement. At Oravax’s request Baxter shall
provide Oravax with evidence of the existence and maintenance of such
cover.
	 
	10.9	 	Oravax undertakes to ensure that it has in place insurance (including,
without limitation, product liability insurance) with a reputable insurer
in an amount appropriate for the business, products and equipment,
including, without limitation, Special Order Equipment, of the type the
subject of this Agreement, and for its obligations under this Agreement.
At Baxter’s request, Oravax shall provide Baxter with evidence of the
existence and maintenance of such cover.
	 
	10.10	 	Baxter undertakes to ensure that it has in place insurance with a
reputable insurer in an amount sufficient for the purposes of conducting
or having conducted any clinical trials including, without limitation,
insurance cover for liability to provide no fault compensation as sponsor
of a clinical trial. At Oravax’s request Baxter shall provide Oravax with
evidence of the existence and maintenance of such cover.
	 
	11	 	ADVERSE DRUG EVENTS AND PRODUCT RECALLS
	 
	11.1	 	Baxter shall be responsible for conducting any recall of defective
Product and Oravax shall co-operate with and give all reasonable
assistance to Baxter in conducting any such recall, at Baxter’s expense.
	 
	11.2	 	Each of Baxter and Oravax shall keep the other informed of any adverse
drug event involving the Products or products containing the same active
ingredient as the Products coming to their attention and able to be
disclosed to the other. Oravax shall cooperate with Baxter in any
necessary and appropriate investigation of any complaint on the Products.
Baxter shall be solely responsible for reporting any and all Product
complaints to relevant Agencies.
	 
	11.3	 	Each of Baxter and Oravax shall keep the other informed of any material
change or event in the market relevant to the Products coming to their
attention and able to be disclosed to the other.
	 
	12	 	HEALTH AND SAFETY
	 
	 	 	Baxter warrants to Oravax that, except to the extent any such risk has
been previously and specifically notified in writing to Oravax, there is
no risk to the health or safety of the employees of Oravax which may be
caused by the Working Seeds, the Products, any of their constituent
elements and/or the process of Manufacture as provided by Baxter and
Baxter hereby agrees to indemnify and keep indemnified Oravax from and
against all claims, demands, actions, proceedings, damages, compensation,
interest, or legal costs arising out of or attributable to any damage
suffered by its employees, sub-contractors or agents and caused by the
Working Seeds, the Products, any of their constituent elements

18

 

	 	 	and/or the process of Manufacture, other than as a direct consequence of
any act or omission of Oravax in breach of this Agreement.
	 
	13	 	NON-SOLICITATION OF EMPLOYEES
	 
	 	 	Subject to Clause 17.1, neither Baxter nor Oravax shall without the
others prior written consent, during the term of this Agreement nor for a
period of one (1) year after its expiry or termination for whatever
reason whether directly or indirectly and in any capacity whatsoever
(whether on its own behalf or on behalf of any other person firm or
company) employ or receive consultancy services from any employee or
officer of the other Party.
	 
	14	 	COMMENCEMENT AND TERM
	 
	 	 	This Agreement shall commence upon the date of signature hereof and
unless previously terminated in accordance with Clause 15 and Clause 17,
this Agreement may be terminated by either Baxter or Oravax giving not
less than three (3) years prior notice of the termination to the other
such notice not to be served prior to the expiry of the third anniversary
of the commencement of this Agreement.
	 
	15	 	TERMINATION
	 
	15.1	 	Either of Baxter or Oravax (the “Notifying Party”) may terminate this
Agreement with immediate effect by notice if the other (the “Defaulting
Party”):

	 	15.1.1	 	commits a material breach, or a persistent minor breach, of an
obligation under this Agreement and which (in the case of a breach
capable of remedy) has not been remedied within ninety (90) days (or
fifteen (15) days in the case of payment defaults) of receipt of a
written notice to remedy from the Notifying Party; or
	 
	 	15.1.2	 	files in any court, pursuant to any statute of any government in
any country, a petition in bankruptcy or insolvency or for
reorganisation, or for an arrangement or for the appointment of a
receiver or trustee of the Party or of its assets; or proposes a
written agreement of composition for extension of its debts; or is
served with an involuntary petition against it, filed in any
insolvency proceeding, and such petition is not dismissed within
sixty (60) days after filing thereof; or is subject to any
dissolution or liquidation, or makes a general assignment for the
benefit of its creditors; or is subject to any final order of
debarment which can be expected to have a material adverse effect on
the sales of the Product; or
	 
	 	15.1.3	 	ceases to carry on its business or substantially the whole of its
business.

	15.2	 	Baxter may terminate this Agreement on three (3) months notice in writing
if the Canton Facility is not designed and constructed within twenty-four
(24) months from the date of this Agreement.
	 
	15.3	 	On termination of this Agreement, Clauses 10, 18, 31, 32 and 34 shall
survive and continue in full force and effect but all other rights and
obligations of the Parties shall cease immediately. Termination does not
affect the Parties’ accrued rights and obligations as at termination.

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	16	 	CONSEQUENCES OF TERMINATION
	 
	16.1	 	On termination of this Agreement for any reason except termination by
Baxter under Clause 15.1.1, Oravax shall, at its option, immediately cease
Manufacture or complete in-process Manufacture and, in the event that
Oravax elects to complete in-process Manufacture, Baxter shall purchase
such Products ordered by Baxter under Clause 5 and which Oravax is under
contract to supply on terms consistent with Clauses 6 and 7.
	 
	16.2	 	On termination of this Agreement by Baxter under Clause 15.1.1, Oravax
shall, at Baxter’s option, immediately cease Manufacture or complete
in-process Manufacture and in the event that Baxter opts to have Oravax
complete in-process Manufacture, Baxter shall purchase such Products on
terms consistent with Clauses 6 and 7.
	 
	16.3	 	Subject to Clause 16.1 and 16.2 each Party shall deliver up to the other
all materials, reports, and other documents (including copies thereof) in
its possession or control containing information of the other party, and
each will cease to make use of the other’s Technical Information.
	 
	17	 	BAXTER’S OPTION TO ACQUIRE THE CANTON FACILITY
	 
	17.1	 	In the event:

	 	17.1.1	 	of a Change of Control of the Guarantor during the first three (3)
years of this Agreement; or
	 
	 	17.1.2	 	that Oravax ceases to be an Affiliate of the Guarantor during the
first three (3) years of this Agreement; or
	 
	 	17.1.3	 	that Oravax receives a Warning Letter from the FDA or any other
Agency and fails to take the required corrective action within the
period of time required by the FDA or other Agency,

	 	 	Baxter shall have the right (but not the obligation) to acquire the
Canton Facility as a going concern or, if appropriate, the company to
which Oravax transfers the Canton Facility pursuant to Clause 17.2.6.
	 
	17.2	 	The option shall be exercised as follows:

	 	17.2.1	 	Oravax shall promptly notify Baxter in writing of an event
referred to in Clause 17.1;
	 
	 	17.2.2	 	Baxter shall have thirty (30) days from receipt of Oravax’s
notification under Clause 17.2.1 to notify Oravax in writing whether
or not it wishes to acquire the Canton Facility;
	 
	 	17.2.3	 	If, pursuant to Clause 17.2.2, Baxter notifies Oravax that it
wishes to acquire the Canton Facility, Baxter and Oravax shall enter
into good faith negotiations to agree on the terms of the
acquisition for a period of ninety (90) days from the date of
receipt of Baxter’s notice. The terms of the acquisition shall be
negotiated in accordance with the following principles:

	 	(a)	 	all material agreements relating to the
Canton Facility (other than third party manufacturing
agreements) shall be assigned to Baxter (and

20

 

	 	 	 	Oravax shall ensure that all such agreements are
assignable to Baxter), subject to Baxter bearing the
burden thereof;
	 
	 	(b)	 	all non-material agreements relating to the
Canton Facility shall be terminable at will;
	 
	 	(c)	 	Baxter shall offer employment to all of the
employees of the Canton Facility on terms no less
favourable than those under which they were employed
immediately prior to the date of completion of the
acquisition; and
	 
	 	(d)	 	all other terms shall be consistent with an
acquisition providing for the transfer of all right, title
and interest in and to the Canton Facility free of all
liens and encumbrance, and on terms customary in the State
of Massachusetts. Baxter’s right to acquire the Canton
Facility shall lapse if the acquisition has not been
completed within such ninety (90) day period, unless the
failure to complete has (as at such date) been referred to
arbitration pursuant to Clause 17.2.8,

	 	 	 	it being agreed that if Baxter purchases shares in the Transfer
Company (as hereinafter defined in Clause 17.2.6) then
sub-clauses 17.2.3(a), (b) and (c) shall not apply.
	 
	 	17.2.4	 	The consideration to be paid by Baxter for the Canton Facility
shall be ten million dollars (US$10m) plus the Net Book Value of
capitalised expenditures made by Oravax since 1 December 2000 and
Oravax’s share of the Operating Expenditure made in relation to
Commissioning. The total consideration shall not exceed twenty-four
million dollars (US$24m).
	 
	 	 	 	For the purpose of this sub-clause “Net Book Value” means gross
capitalised expenditures (for the avoidance of doubt excluding
any capitalised expenditure incurred by Baxter under this
Agreement) less accumulated depreciation.
	 
	 	17.2.5	 	Baxter and Oravax agree that, on exercise of the option referred
to in this Clause 17, they shall in good faith negotiate, for a
period of ninety (90) days commencing from the date of receipt of
Baxter’s notice in Clause 17.2.2, the terms on which Baxter shall
continue to manufacture the products which at that time are being
manufactured in the Canton Facility for Oravax (or for a third party
pursuant to a contract manufacturing arrangement between Oravax and
a third party) and enter into a contract manufacturing agreement on
completion (the “Oravax Contract Manufacturing Agreement”). The
Oravax Contract Manufacturing Agreement shall be modelled on the
commercial terms of this Agreement to the extent it is relevant or
the applicable third party manufacturing agreement. The terms of
the Oravax Contract Manufacturing Agreement shall be three (3)
years.
	 
	 	17.2.6	 	Baxter agrees that Oravax may transfer the Canton Facility to a
member of its Group at the same time as transferring its rights and
obligations under this Agreement to such member (the “Transfer
Company”), provided that (i) the activities of that member of its
Group are restricted to the Canton Facility, and (ii) both such
transfers take place in accordance with Clause 21; and that (iii)
the provisions of Clause 17.2.3 shall apply to the Transferee
Company in the same way as they apply to the Canton Facility.

21

 

	 	17.2.7	 	Oravax agrees to procure that the same rights which Oravax has in
respect of the Canton Facility shall be transferred to Baxter, or to
the Transferee Company, as appropriate, pursuant to Clauses 17.2.3
or 17.2.6, as applicable.
	 
	 	17.2.8	 	If Baxter and Oravax are unable to agree either or both of (i) the
terms of acquisition pursuant to Clause 17.2.3; or (ii) the terms of
the Oravax Contract Manufacturing Agreement pursuant to Clause
17.2.5, the dispute shall be referred to, and be settled by, binding
arbitration in accordance with the Center for Public Resources
Non-Administered Arbitration Rules in effect on the date of this
Agreement, by three (3) independent and impartial arbitrators, none
of whom shall be appointed by Baxter or Oravax. The arbitration
shall be governed by the United States Arbitration Act, 9 U.S.C. ss
1-16, and judgment upon the award rendered by the arbitrators may be
entered by any court having jurisdiction thereof. The place of the
arbitration shall be Delaware. The governing, substantive and
procedural law shall be that of Delaware. The arbitrators are not
empowered to award damages in excess of compensatory damages.

	17.3	 	On completion of Baxter’s acquisition of the Canton Facility, this Agreement shall terminate.
	 
	18	 	CONFIDENTIALITY
	 
	18.1	 	From the date of this Agreement and for five (5) years after termination each Party shall:

	 	18.1.1	 	keep confidential (i) all information (written, oral or
electronic) disclosed to it by the other Party (the “Disclosing
Party”) and concerning the business and affairs of the Disclosing
Party including but not limited to any information relating to the
Disclosing Party’s operations, processes, plans, intentions, product
information, know-how, designs, trade secrets, software, market
opportunities and customers and (ii) the provisions of this
agreement and the negotiations relating to it (together, the
“Confidential Information”);
	 
	 	18.1.2	 	use the Confidential Information solely in accordance with its
performance of this Agreement and in particular, but without
prejudice to the generality of the foregoing, not make any
commercial use thereof or use the same for the benefit of itself or
of any third Party other than pursuant to this Agreement or a
further agreement with the Disclosing Party;
	 
	 	18.1.3	 	not disclose the Confidential Information to any person other than
those of its employees, directors or advisers who need to know the
Confidential Information for the purposes of the Agreement or the
Business (a “Recipient”) and, at its cost, shall take all reasonable
steps, which in any event should be not less than the receiving
Party (the “Receiving Party”) would take to protect its own
confidential information, to ensure that any Recipient complies with
these confidentiality obligations as if they were a party to this
Agreement; and
	 
	 	18.1.4	 	at the request of the Disclosing Party or at the conclusion of its
authorised use, return to the Disclosing Party all documents and
materials (and all copies thereof) containing the Disclosing Party’s
Confidential Information, erase all Confidential Information from
their computer systems (to the extent possible) and certify in
writing to the Disclosing Party that it has complied with the
requirements of this Clause.

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	18.2	 	Baxter’s Confidential Information relating to regulatory files or BLA
documentation in respect of the Products shall only be disclosed by Oravax
to those persons who need to know such Confidential Information and who
execute a confidentiality agreement addressed to Baxter in a from approved
by Baxter and Oravax.
	 
	18.3	 	This Clause does not apply to Confidential Information which:-

	 	18.3.1	 	is in or comes into the public domain other than by breach of this
Agreement or of any obligation of confidence owed by the Receiving
Party or a Recipient to the disclosing Party;
	 
	 	18.3.2	 	the Receiving Party can show it knew prior to disclosure by the
Disclosing Party;
	 
	 	18.3.3	 	was subsequently disclosed to the Receiving Party lawfully by a
third party who did not obtain the same (whether directly or
indirectly) from the Disclosing Party; or
	 
	 	18.3.4	 	is subsequently disclosed by the Disclosing Party to a third party
without restriction on disclosure or use.

	18.4	 	Notwithstanding the foregoing, the Receiving Party shall be entitled to
make any disclosure:-

	 	18.4.1	 	required by law or by any governmental or other regulatory
authority (including without limitation a recognised stock exchange
in the USA or Europe) provided that it gives the other Party as much
notice of such disclosure as practicable; and
	 
	 	18.4.2	 	required to be disclosed to an Agency for the purposes of this
Agreement.

	18.5	 	Each Party reserves all rights in its Confidential Information and no
rights or obligations other than those expressly recited herein are
granted by or to be implied from this Agreement. In particular, no
licence is hereby granted directly or indirectly under any patent,
invention, discovery, copyright or other intellectual property right now
or in the future held, made, obtained, or licensable by any Party.
	 
	19	 	ANNOUNCEMENTS
	 
	19.1	 	Subject to Clause 19.2, no announcement or public statement concerning
the existence, subject matter or any term of this Agreement shall be made
by or on behalf of either of Baxter or Oravax without the prior written
approval of the other such approval not to be unreasonably withheld or
delayed.
	 
	19.2	 	This Clause shall not apply to any announcement, public statement or
circular by either of Baxter or Oravax required by law, a securities
exchange or a regulatory or governmental body to which such of Baxter or
Oravax (as the case may be) is subject, including the rules of a stock
exchange, in which case the Party concerned shall make all reasonable
attempts to agree the contents of such announcement or statement with the
other Party before making the announcement or statement.

23

 

	20	 	FORCE MAJEURE
	 
	20.1	 	In this Agreement, “Force Majeure” means any cause preventing either of
Baxter or Oravax from performing any or all of its obligations and which
arises from or is attributable to acts, events, omissions or accidents
beyond the reasonable control of the Party so prevented.
	 
	20.2	 	If either of Baxter or Oravax is prevented or delayed in the performance
of any of its obligations under this Agreement by Force Majeure, that
Party shall as soon as reasonably practicable notify the other Party
specifying the nature and extent of the circumstances giving rise to Force
Majeure and shall, subject to service of such notice and to Clause 20.5,
have no liability in respect of the performance of such of its obligations
as are prevented by Force Majeure events during the continuation of such
events, and for such time after they cease as is reasonably necessary for
that Party, who shall use all reasonable endeavours both to notify the
other Party of the end of the Force Majeure event and to recommence its
affected operations in order for it to perform its obligations under this
Agreement.
	 
	20.3	 	If Oravax is prevented from supplying Products under this Agreement as a
result of a Force Majeure event for a continuous period in excess of one
(1) month, Baxter may purchase alternative products from another party
without being in breach of Clause 4.1. On cessation of the Force Majeure
event, Baxter shall resume purchasing Products exclusively from Oravax.
	 
	20.4	 	If either Baxter or Oravax is prevented from performance of its
obligations as a result of the Force Majeure event for a continuous period
in excess of six (6) months, the other Party may terminate this Agreement
on service of thirty (30) days notice upon the Party so prevented.
	 
	20.5	 	The Party claiming to be prevented or delayed in the performance of any
of its obligations under this Agreement by reason of Force Majeure shall
use all reasonable endeavours to bring the Force Majeure event to a close
or to find a solution by which the Agreement may be performed despite the
continuance of the Force Majeure event.
	 
	21	 	ASSIGNMENT AND SUB-CONTRACTING
	 
	 	 	Neither Baxter nor Oravax shall be entitled to assign or transfer or
sub-contract all or any of its rights, benefits or obligations under this
Agreement without the prior written consent of the other Party except
that either of Baxter or Oravax may assign or transfer or sub-contract
its rights or obligations under this Agreement to another member of its
Group. For the avoidance of doubt, the Parent Company Guarantee shall
apply to the obligations of any Oravax assignee under this Clause.
	 
	22	 	ENTIRE AGREEMENT
	 
	22.1	 	This Agreement constitutes the entire agreement and understanding of the
Parties and supersedes any previous agreement between the Parties (whether
written or oral) relating to the subject matter of this Agreement and
without prejudice to the generality of the foregoing, excludes any
warranty, condition or other undertaking implied at law or by custom.
	 
	22.2	 	The terms of this Agreement shall prevail over any inconsistent terms of
any standard terms and conditions, purchase orders, acceptance notices and
other documents exchanged between the Parties pursuant to this Agreement.

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	23	 	ILLEGALITY AND SEVERANCE
	 
	23.1	 	If a provision of this Agreement is, or but for this Clause would be,
held to be illegal, invalid or unenforceable, in whole or in part, in the
jurisdiction to which it pertains but would be legal, valid and
enforceable if the period applicable or geographical application were
reduced, the provision shall apply with the minimum modification necessary
to make it legal, valid and enforceable in that jurisdiction, and any such
illegality, invalidity or unenforceability in any jurisdiction shall not
invalidate or render invalid or unenforceable such provisions in any other
jurisdiction.
	 
	23.2	 	If a provision of this Agreement is held to be illegal, invalid or
unenforceable, in whole or in part and Clause 23.1 cannot be used to make
it legal, valid and enforceable, a Party may require the other Party to
enter into a new agreement under which that Party undertakes in the terms
of the original provision, but subject to such amendments as the first
Party specifies in order to make the provision legal, valid and
enforceable. No Party will be obliged to enter into a new agreement that
would increase its liability beyond that contained in this Agreement, had
all its provisions been legal, valid and enforceable.
	 
	24	 	VARIATION
	 
	 	 	Any variation of this Agreement must be in writing and signed by each
Party or, in the case of a corporation, a duly authorised officer or
representative of such Party.
	 
	25	 	WAIVER
	 
	 	 	A delay in exercising, or failure to exercise, any right or remedy under
this Agreement does not constitute a waiver of such or other rights or
remedies nor shall operate so as to bar the exercise or enforcement
thereof.
	 
	26	 	COSTS
	 
	 	 	Except where this Agreement provides otherwise, each Party shall pay its
own costs and expenses (including legal fees) arising from the
negotiation and preparation of this Agreement.
	 
	27	 	RIGHTS OF THIRD PARTIES
	 
	 	 	This Agreement shall not confer any rights or remedies upon any person or
entity other than Baxter, Oravax and their respective successors and
permitted assigns.
	 
	28	 	COUNTERPARTS
	 
	 	 	This Agreement may be executed in any number of counterparts, each of
which when executed and delivered shall constitute an original of this
Agreement, but all the counterparts shall together constitute one and the
same agreement. No counterpart shall be effective until each Party has
executed at least one part or counterpart.
	 
	29	 	EXCLUSION OF AGENCY, PARTNERSHIP OR JOINT VENTURE
	 
	 	 	Nothing in this Agreement or any arrangement contemplated by it shall be
construed as establishing or implying any partnership between the
Parties, and nothing in this Agreement shall be deemed to constitute
either of the Parties as the agent of the other Party or to authorise the
other Party to bind, contract in the name of or to create a liability for
the other Party in any way or for any purpose.

25

 

	30	 	NOTICES
	 
	30.1	 	Any notice given under this Agreement shall be in writing and shall be
served by delivering it to the Party due to receive it at the address or
fax numbers set out in Clause 30.2 and shall be deemed to have been
delivered in accordance with Clause 30.3.
	 
	30.2	 	The Parties’ addresses and fax numbers for the purposes of this Agreement
are:

	 	 	Baxter Healthcare Corporation
	 	 	One Baxter Parkway
	 	 	Deerfield
	 	 	Illinois, 60015-4663
	 	 	USA
	 	 	For the attention of: [name, position]
	 	 	Fax number: [        ]
	 
	 	 	Baxter Healthcare S.A.
	 	 	[Address]
	 	 	For the attention of: [name, position]
	 	 	Fax number: [        ],
	 
	 	 	OraVax Inc.
	 	 	38 Sidney Street
	 	 	Cambridge
	 	 	Massachusetts 02139
	 	 	USA
	 	 	For the attention of: [name, position]
	 	 	Fax number: [        ],
	 
	 	 	Peptide Therapeutics Group plc
	 	 	Peterhouse Technology Park
	 	 	100 Fulbourn Road
	 	 	Cambridge CB1 9PT
	 	 	For the attention of: [name, position]
	 	 	Fax number: [        ],
	 
	 	 	or such other address or fax number as the relevant Party notifies to the
other Party, which change of address shall only take effect if delivered
and received in accordance with this Clause.
	 
	30.3	 	A notice so addressed shall be deemed to have been received:

	 	30.3.1	 	if personally delivered, at the time of delivery;
	 
	 	30.3.2	 	if sent by pre-paid first class mail, two (2) Business Days after
the date of mailing to the relevant address;
	 
	 	30.3.3	 	if sent by registered or certified mail, five (5) Business Days
after the date of mailing to the relevant address; or
	 
	 	30.3.4	 	if sent by fax, on successful completion of its transmission, save
that if such notice or communication is received after the end of
normal working hours

26

 

	 	 	 	(and “normal working hours” shall be deemed to be 8.30 am and
5.30 p.m. on any Business Day, such notice or communication
shall be deemed to have been received on the next Business Day.

	30.4	 	For the avoidance of doubt, notice given under this Agreement shall not
be validly served if sent by e-mail.
	 
	31	 	GOVERNING LAW
	 
	 	 	This Agreement is governed by, and shall be construed in accordance with,
Delaware law without regard to its conflict of law rules.
	 
	32	 	JURISDICTION
	 
	 	 	Each Party irrevocably agrees that the courts of Delaware have exclusive
jurisdiction to decide and settle any dispute or claim arising out of or
in connection with this Agreement, except as provided for in Clause
17.2.8.
	 
	33	 	INTEREST TO RUN ON DEFAULT
	 
	 	 	If any Party defaults in the payment when due of any sum payable under
this Agreement interest on such sum shall be payable by the defaulting
Party from the date when such payment is due until the date of actual
payment (as well after as before judgment) at a rate per annum of two per
cent above the prime rate from time to time listed in the Wall Street
Journal. Such interest shall accrue from day to day and shall be paid
subject to any withholding tax.
	 
	34	 	PARENT COMPANY GUARANTEE
	 
	34.1	 	The Guarantor irrevocably and unconditionally guarantees to Baxter the
due and punctual performance of each obligation of Oravax contained in
this Agreement. The Guarantor shall pay to Baxter from time to time on
demand any sum of money which Oravax is at any time liable to pay to
Baxter under or pursuant to this Agreement and which has not been paid at
the time the demand is made. The Guarantor’s obligations under clause
34.1 are primary obligations and not those of a mere surety. If an
obligation of Oravax is void, voidable or unenforceable for any reason,
the Guarantor’s obligations under clause 34.1 are unaffected and the
Guarantor shall perform Oravax’s obligations as if it were primarily
liable for the performance.
	 
	34.2	 	The Guarantor’s obligations under clause 34.1 are continuing obligations
and are not satisfied, discharged or affected by an intermediate payment
or settlement of account by, or a change in the constitution or control
of, or the insolvency of, or bankruptcy, winding up or analogous
proceedings relating to Oravax.
	 
	34.3	 	The Guarantor’s liability under clause 34.1 is not affected by an
arrangement which Baxter may make with Oravax or with another person which
(but for clause 34.3) might operate to diminish or discharge the liability
of or otherwise provide a defence to a surety.
	 
	34.4	 	Without affecting the generality of clause 34.3, Baxter may at any time
as it thinks fit and without reference to the Oravax:

	 	34.4.1	 	grant a time for payment or grant another indulgence or agree to
an amendment, variation, waiver or release in respect of an
obligation of Oravax under this Agreement;

27

 

	 	34.4.2	 	give up, deal with, vary, exchange or abstain from perfecting or
enforcing other securities or guarantees held by Baxter;
	 
	 	34.4.3	 	discharge a party to other securities or guarantees held by Baxter
and realise all or any of those securities or guarantees; and
	 
	 	34.4.4	 	compound with, accept compositions from and make other
arrangements with Oravax or a person or persons liable on other
securities or guarantees held or to be held by Baxter.

	34.5	 	So long as Oravax is under an actual or contingent obligation under this
Agreement the Guarantor shall not exercise a right which it may at any
time have by reason of the performance of its obligations under clause
34.1 to be indemnified by Oravax to claim a contribution from another
surety of Oravax’s obligations or to take the benefit (wholly or partly
and by way of subrogation or otherwise) of any of Baxter’s rights under
this Agreement or of any other security taken by Baxter in connection with
this Agreement.
	 
	34.6	 	The Guarantor’s liability under clause 34.1 is not affected by the
avoidance of an assurance, security or payment or a release, settlement or
discharge which is given or made on the faith of an assurance, security or
payment, in either case, under an enactment relating to bankruptcy or
insolvency.

28

 

	 	 	 	 	 
	EXECUTED by the Parties:	 	 	 	 
	 	 	 	 	 
	Signed by	 	 	 	)
	a duly authorised representative of	 	 	 	)
	BAXTER HEALTHCARE CORPORATION:	 	 	 	)
	 	 	 	 	 
	                                           Signature	 		 	 
	 	 	 	 	 
	Signed by	 	 	 	)
	a duly authorised representative of	 	 	 	)
	BAXTER HEALTHCARE S.A.:	 	 	 	)
	 	 	 	 	 
	                                           Signature	 		 	 
	 	 	 	 	 
	Signed by	 	 	 	)
	a duly authorised representative of	 	 	 	)
	ORAVAX INC.:	 	 	 	)
	 	 	 	 	 
	                                           Signature	 		 	 
	 	 	 	 	 
	Signed by	 	 	 	)
	a duly authorised representative of	 	 	 	)
	PEPTIDE THERAPEUTICS GROUP PLC:	 	 	 	)
	 	 	 	 	 
	                                           Signature	 		 	 

29

 

SCHEDULE 1

THE PRODUCTS

[ * * * * ]

30

 

SCHEDULE 2

THE PROCESS

[ * * * * ]

31

 

SCHEDULE 3

PRODUCT SPECIFICATIONS

[ * * * * ]

32

 

SCHEDULE 4

TECHNICAL SCHEDULE

[ * * * * ]

33

 

SCHEDULE 5

OPERATING EXPENDITURE

[ * * * * ]

34

 

EXHIBIT A

[ * * * * ]

35

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