Document:

Exhibit 4.9

Transaction Agreement

 

dated as of December 1, 2005

 

by and between

 

Crucell N.V.

Archimedesweg 4

P.O. Box 2048

NL - 2301 CA Leiden

The Netherlands

(hereinafter Crucell)

and

Berna Biotech AG

Rehhagstrasse 79

CH - 3018 Berne

Switzerland

(hereinafter Berna)

 

 

Table of
Contents

	
  1.

  	
  Definitions

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.

  	
  Public Offer

  	
  5

  
	
   

  	
   

  	
   

  
	
  3.

  	
  Support of the Public Offer by Berna

  	
  7

  
	
   

  	
   

  	
   

  
	
  4.

  	
  Extraordinary Meetings of Berna Shareholders

  	
  10

  
	
   

  	
   

  	
   

  
	
  5.

  	
  Certain Representations and Obligations of the
  Parties

  	
  12

  
	
   

  	
   

  	
   

  
	
  6.

  	
  ESOP Options and ESPP Shares

  	
  17

  
	
   

  	
   

  	
   

  
	
  7.

  	
  Press Releases and Other Public Announcements;
  Confidentiality

  	
  18

  
	
   

  	
   

  	
   

  
	
  8.

  	
  Costs and Expenses

  	
  19

  
	
   

  	
   

  	
   

  
	
  9.

  	
  Termination

  	
  19

  
	
   

  	
   

  	
   

  
	
  10.

  	
  Governing Law and Arbitration

  	
  21

  

 

 2
 

 

 

Table of Annexes

	
  A

  	
  ESOP Options and ESPP Shares

  
	
   

  	
   

  
	
  B

  	
  Crucell’s Employee Stock Options

  
	
   

  	
   

  
	
  C

  	
  Minutes of Meeting of Berna Board

  
	
   

  	
   

  
	
  1

  	
  Definitions

  
	
   

  	
   

  
	
  2.3

  	
  Draft Pre-Announcement of Public Offer

  
	
   

  	
   

  
	
  3.1

  	
  Press Release

  
	
   

  	
   

  
	
  3.2

  	
  Berna Board Report

  
	
   

  	
   

  
	
  3.11

  	
  Undertakings of Berna Board Members

  
	
   

  	
   

  
	
  4.1

  	
  Invitation to Berna Shareholders’ Meeting

  
	
   

  	
   

  
	
  4.6

  	
  Resignation Declarations of certain Board Members

  
	
   

  	
   

  
	
  5.1.7

  	
  Chart of Berna Group

  
	
   

  	
   

  
	
  5.1.9

  	
  Fairness Opinion

  

 

 3
 

 

 

This Transaction
Agreement (including all of its annexes the Agreement)
is made with effect as of December 1, 2005, by and between Berna Biotech
AG, Berne, Switzerland (Berna) and Crucell
N.V., Leiden, The Netherlands (Crucell).

Whereas:

A.                         Berna
is a Swiss corporation (Aktiengesellschaft)
limited by shares registered in Berne, Switzerland, with an issued share
capital of CHF 15,041,495.20 divided into 37,603,738 registered shares
with a par value of CHF 0.40 each (the Berna
Shares), which are listed on the SWX Swiss Exchange. In addition,
Berna has a conditional share capital allowing for the issuance of 1,146,262
additional shares in connection with its employee stock option plan (Mitarbeiter-Optionsplan; last version March 31,
2004) (ESOP) and its employee share
participation plan (Mitarbeiter-Aktienplan;
last version April 30, 2003) (ESPP). 31,301
of the issued Berna Shares are locked-up under Berna’s ESPP as further set
forth in Annex A. Berna has a total of 1,421,325 options for Berna
Shares outstanding under its employee stock option plan, as further set forth
in Annex A, that, upon exercise, would result in the issuance of an
additional 1,146,262 Berna Shares and the purchase of 275,063 Berna Shares on
the market. Berna has no other shares, options or conversion rights issued or
outstanding or promised or owed now or for the future to employees or otherwise.

B.                           Crucell
is a Dutch corporation, having its corporate seat in Leiden, The Netherlands,
with an authorized share capital of EUR 40,800,000 divided into 85,000,000
ordinary shares (the Crucell Shares)
and 85,000,000 preference shares of EUR 0.24 each; the issued share
capital amounts to EUR 9,940,947.12 divided into 41,420,613 Crucell
Shares. The Crucell Shares are listed on Euronext Amsterdam N.V.’s Eurolist by
Euronext and quoted on NASDAQ in the form of American Depository Shares (ADSs),
both under the symbol “CRXL”. Crucell maintains an employee stock option plan.
Crucell has a total of options for Crucell Shares outstanding under its
employee stock option plan as further set forth in Annex B, that,
upon exercise, would result in the issuance of additional Crucell Shares.
Crucell has no other shares, options or conversion rights issued or outstanding.

C.                           The
management board of Crucell with the approval of the Crucell Supervisory Board
has resolved to pre-announce and, subject to the terms and conditions of this
Agreement, to submit a public tender offer to all shareholders of Berna, and
Berna desires to support such public tender offer and

 4
 

 

 

to publish in connection with such offer a Berna Board
report recommending to the Berna shareholders to accept such offer; and the
Berna Board has, as set out in Annex C, at its meeting of November 30,
2005, unanimously, with one abstention, resolved to recommend and support the
Public Offer as defined in this Agreement and to publish such board report together
with the Public Offer.

Now, therefore, the parties
hereto agree as follows:

1.             Definitions

Capitalized terms
used in this Agreement shall have the meaning assigned to them in Annex 1.

2.             Public Offer

2.1                                 Subject
to the terms and conditions of this Agreement, Crucell shall launch a public
tender offer to Berna’s shareholders for all Berna Shares consistent with Swiss
takeover laws and regulations (the Public
Offer). Subject to prior consultation with Berna, Crucell may
exclude any Berna shareholders and|or Berna Shares that are located in
jurisdictions, where such offer or its acceptance would (i) be illegal or (ii) require
the observance of takeover and other securities laws and regulations other than
Swiss takeover and securities laws and regulations or (iii) require
filings with or approvals by takeover authorities other than the Swiss takeover
authorities. In particular, Crucell contemplates to exclude any persons in the
United States and retail shareholders in the U.K. from the Public Offer. The
Public Offer shall be subject to conditions agreed upon by the parties as set
out in Annex 2.3.

2.2                                 In
the Public Offer, Crucell shall offer 0.447 Crucell Shares (the Crucell Exchange Shares) with par value of
EUR 0.24 each to be newly issued to the holders of Berna Shares (Crucell Exchange Share Offering) for each
Berna Share (Exchange Ratio).
Crucell shall be entitled, in its own discretion, to adjust the Exchange Ratio
for the gross amount of any dilutive effects, including but not limited to
dividend payments, demergers, capital increases with an issuance price per
share below the stock market price, issuance of options with a strike price per
share below the stock market price, and repayments of capital. The Exchange
Ratio will not be adjusted for the dilutive effect occurring as a result of the
issue of up to 893,000 Berna Shares upon exercise of the option rights granted to
members of the Berna management and employees under the ESOP, which are in the
money as per their current terms and conditions.

 5
 

 

 

2.3                                 Crucell
shall pre-announce the Public Offer on December 1, 2005, in electronic
media by means of a pre-announcement in German and French, substantially with
the content of the English draft attached hereto as Annex 2.3 (Pre-Announcement), which shall be followed
by a publication in newspapers in due course in accordance with Swiss takeover
law. Save with respect to matters that are immaterial, Crucell shall consult
with Berna and|or its advisors with respect to any changes that it may intend
to make to the content of the draft Pre-Announcement attached hereto as Annex 2.3.

The parties currently contemplate that Crucell publish, on or about December 15,
2005, after receiving acceptable ruling of the Swiss takeover board on the compliance
with Swiss takeover laws, reasonably acceptable to Crucell, the Public Offer
prospectus in German and in French
in accordance with Swiss takeover law. The Public Offer will remain open for at
least twenty trading days.

2.4                                 Crucell
shall make all notifications and filings and take all other actions as
commercially reasonable to procure the fulfilment of the conditions to the
Public Offer set out in Section (b) (merger
control and other approvals), (j) (approval of the Crucell shareholders’ meeting), and (k) (admission to listing) of Annex 2.3
as expeditiously as commercially reasonably possible.

In particular, with regard to Section (j) of Annex 2.3
(approval of the Crucell shareholders’ meeting),
concurrent with the publication of the Public Offer prospectus, Crucell shall invite
its shareholders to an extraordinary meeting and re­commend the approval of the
Public Offer. Such extraordinary meeting of the Crucell shareholders is
expected to take place on or about 18 days after the launch of the Public
Offer, taking, however, into account the holiday season (currently contemplated
on January 10, 2006). Members of the Berna Board and management as well as
Berna’s advisers will be invited to attend the extraordinary meeting(s) of
the Crucell shareholders. Crucell shall procure that Berna and its advisors are
given due opportunity to review, and comment on, the invitation to the meeting
of the Crucell shareholders and the resolutions submitted for shareholders’
approval, and consult with Berna on all other relevant matters in connection
with the meeting of the Crucell shareholders.

2.5                                 It
is the parties’ intention that,
following the settlement of the Public Offer, the Crucell Supervisory Board shall be composed of a maximum of
9 directors, including the 3 directors designated by Berna. Therefore, Crucell shall schedule and recommend in
the invitation to the extraordinary meeting of the shareholders the election of
the following three persons to the Crucell Supervisory Board sub-

 

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ject to the Public Offer being settled. Currently, it is
contemplated that these are: Claude Thomann, Dominik Koechlin and Jürg Witmer.

2.6                                 The
parties confirm that subject to the Public Offer being settled, new employment
agreements shall be offered to Kuno Sommer, Rolf Gasser, Simon Rothen, Jörg von
Manger-König and Patrik Richard if they so desire, the terms and conditions of
which shall be equivalent to the current terms and conditions (or better if
agreed by Berna and Crucell).

2.7                                 Crucell
shall in accordance with the relevant laws and regulations apply for the
listing of the Crucell Exchange Shares on Eurolist by Euronext Amsterdam for a
first trading date by or shortly after the settlement of the Public Offer. In
addition, Crucell shall apply for a secondary listing of the Crucell Exchange
Shares and of all existing Crucell Shares of the same share category on the SWX
Swiss Exchange for a first trading date as soon as commercially reasonably
possible after the settlement of the Public Offer. Following the settlement,
upon request by Crucell, Berna shall apply for the de-listing of the Berna
Shares.

2.8                                 Crucell
currently contemplates that, following the settlement of the Public Offer,
depending on the acceptance rate, any remaining minority shareholders of Berna
shall be excluded and indemnified by any legal means available, including a
squeeze-out to be effected in accordance with Swiss takeover laws or Swiss
merger laws (as the case may be) or by way of a follow-up private or public
offer.

2.9                                 Regardless
section “Conditions” para 3 of the Pre-Announcement (Annex 2.3),
Crucell hereby agrees that without Berna’s written approval it shall under no
circumstances waive condition (a) of section “Conditions” para 1
of the Pre-Announcement set out in Annex 2.3 (at least 67% of the total number of shares tendered),
unless the number of shares tendered represent (together with shares that
Crucell may otherwise hold) at least 50.1% of the total number of Berna Shares
issued.

3.             Support of the Public Offer by Berna

3.1                                 On
the date of the electronic publication of the Pre-Announcement, Berna and
Crucell shall publish a joint press release announcing the endorsement of the
Public Offer by Berna and that Berna will recommend that the shareholders accept
the Public Offer, substantially as set forth in Annex 3.1.

3.2                                 The
Berna Board shall issue a report to all shareholders of Berna in accordance
with Article 29(1) SESTA substantially in the form of the draft
attached hereto as 

 7
 

 

 

Annex 3.2,
welcoming and endorsing the Public Offer and recommending that the Berna
shareholders accept the Public Offer. Berna
shall issue the final report as early as reasonably necessary for Crucell to
include such report in its filings to the Swiss takeover board and to publish
such report together with the prospectus of the Public Offer.

3.3                                 Berna
and the Berna Board shall actively and publicly support the Public Offer,
including, without limitation, at the extraordinary meeting of the Berna
sharehol­ders, and refrain from any acts, filings or public statements that
could adversely affect the Public Offer or its success. Berna shall include the
prospectus of the Public Offer and any other reasonable information on the
Public Offer prepared by Crucell in its mailings to the Berna shareholders.

3.4                                 Save
where the communication is immaterial, Berna agrees to consult Crucell
sufficiently in advance of any communication (whether written or oral, and
whether consultants or advisors), which it proposes to make or submit to the
Swiss takeover board in connection with the Public Offer. Berna undertakes to
take any reasonable comments, which Crucell or its consultants and advisors may
make in relation to any communication in good faith into account prior to
making such communication. Crucell shall endeavour to consult with Berna or its
legal advisors prior to any material written filing to the Swiss takeover board
and take any reasonable comments in good faith into account prior to such
filing. The parties will inform each other on any material development in the
proceedings with the Swiss takeover board and provide each other with copies of
their written filings. The parties shall endeavour to resolve any disagreements
on the propo­sals submitted to the takeover board among themselves in order to
avoid conflicting communication with the takeover board.

3.5                                 Berna
and the Berna Board shall not, directly or indirectly:

3.5.1                        support
any offer submitted by another party for Berna Shares or securities;

3.5.2                        enter into
any letter of intent, agreement in principle, acquisition agreement or other
similar acquisition agreement relating to any acquisition proposal nor solicit,
initiate or encourage any inquiries or proposals from or discuss with, or
negotiate any offer or proposal from any third party relating to a potential
acquisition in whole or in part of the Berna Group, its shares, assets or
business, whether directly or indirectly, through a public offer, purchase of
shares or assets, merger, consolidation, or otherwise.

 8
 

 

 

3.6                                 In
the event that Berna becomes aware that a third party has the firm intention of
preparing or pursuing an action or transaction that may conflict or compete
with or adversely affect the Public Offer or Crucell’s interest therein, it
shall promptly inform Crucell of the fact of the approach as well as any price
and conditions indicated.

3.7                                 Notwithstanding
Article 3.5.2, the Berna Board will be allowed to receive and to review
any unsolicited indication of firm interest of a third party (including to cla­rify
uncertain issues), be it orally or in writing. The Berna Board will be allowed
to provide to a third party that expressed in writing an unsolicited firm
intention to announce a Superior Offer specifying the main terms and conditions
of such Superior Offer due diligence information if and after, cumulatively,

3.7.1                        Crucell
has been informed on the main terms and conditions of such contemplated
Superior Offer and has had the chance to reasonably present its view to Berna
on such terms and conditions; and

3.7.2                        the Berna
Board believes in good faith, after having consulted with its advisors and
after having given Crucell the opportunity to present its view, that (a) the
Berna Board has an obligation to grant such due diligence access under
Art. 717 Swiss Code of Obligations or under Swiss takeover laws and that (b) such
third party has the capability and the intention of making and consummating a
Superior Offer.

Berna shall inform Crucell if it should
decide to provide such due diligence access.

3.8                                 Berna
shall make all notifications and filings and take all actions which may be
necessary to procure or support the fulfilment of the conditions to the Public
Offer set out in Sections (b) (merger
control and other approvals), (d) (changes of
Berna’s articles of incorporation  removing the
provisions restricting the transfe­rability of the Berna Shares), (e) (the
amendments of the articles of incorporation have been entered into the
commercial register), (f) (registration with voting
rights), (i) (election of board members)
of Annex 2.3 as expeditiously as practicable and to use its
commercially reasonable endeavours to procure and support the fulfilment of
these conditions. Berna shall keep Crucell informed on the progress of the
fulfilment of these conditions and promptly upon fulfilment deliver to Crucell
appropriate evidence, such as amended articles of incorporation, excerpts of
the commercial register, and minutes of the extraordinary meeting(s) of
the Berna shareholders.

 9
 

 

 

3.9                                 On
or by the day on which the conditions set out in Section (d) of Annex 2.3
(changes of Berna’s articles of
incorporation removing the provisions restricting the transferability of the
Berna Shares) are satisfied, the Berna Board shall resolve to
register Crucell as a shareholder with voting rights with respect to all Berna
Shares that Crucell or any of its Subsidiaries may acquire as a result of the
Public Offer or otherwise. Upon settlement of the Public Offer, the Berna Board
shall promptly register Crucell and its Subsidiaries in Berna’s shareholder
register as shareholders with voting rights with respect to all Berna Shares
that Crucell or its Subsidiaries have acquired as a result of the Public Offer
or otherwise.

3.10                           On the
first trading day following the end of the Offer Period, the chairman and the
CEO of Berna shall deliver to Crucell a certificate dated that day confirming
in writing, to the best of their knowledge, the satisfaction of the conditions
to the Public Offer set out in Sections (b) (merger control and other approvals), (c) (no court or other decision) and (g) (no material adverse effect) of Annex 2.3.

3.11                           Berna
shall use commercially reasonable efforts to procure the tender of the Berna
Shares by the Berna shareholders. In particular, without limitation, it shall

3.11.1                  support and
assist in the preparation and procure the participation of the relevant members
of its board of directors and management in road shows, marketing events and
marketing materials;

3.11.2                  directly liaise
with OrbiMed Advisors in order to convince them to tender the Berna Shares
represented by them (or to privately sell their share if held in the US or by
US persons);

3.11.3                  encourage the
retail shareholder base in Switzerland as well as its employees to tender their
Berna Shares.

Attached as Annex 3.11 are the undertakings of members of
Berna’s board of directors that - except in case of a Superior Offer - they
will tender the Berna Shares directly owned or controlled by them in the Public
Offer. For the indirectly owned or controlled Berna Shares, Berna’s board
members will undertake their best efforts to have them tendered.

4.             Extraordinary Meetings of Berna Shareholders

4.1                                 Berna
shall invite its shareholders no later than on the date of the launch of the
Public Offer to an extraordinary meeting of the Berna shareholders and schedule

 10
 

 

 

and recommend
as set forth below and in the invitation of the Berna Board to the
extraordinary meeting of the shareholder attached hereto as Annex 4.1
the following items (or any other items or proposals as may be reasonably
requested by Crucell in order to promote and support a successful Public Offer):

—                                   an
amendment of the articles of incorporation so as to remove the provisions
restricting the transferability with voting rights of the Berna Shares, which
amendment shall not have to be entered into the commercial register, unless
Crucell shall, after the lapse of the Offer Period have declared the Public
Offer successful except for conditions that are or become conditions
subsequent, and

—                                   the
election of three board members designated by Crucell, subject only to the
condition that the Public Offer shall become unconditional. Currently, it is
contemplated that these are: Ronald Brus, Leonard Kruimer and Jaap Goudsmit.

The
extraordinary meeting of the Berna shareholders shall take place on or about January 11,
2005 and in any case not later than five trading days prior to the end of the
Offer Period. Members of the Crucell Supervisory Board and ma­nagement as well
as Crucell’s advisers shall be entitled to attend the extraordinary meeting(s) of
the Berna shareholders.

4.2                                 If
adopted by the extraordinary meeting of the Berna shareholders convened as set
forth in Article 4.1, Berna shall, if Crucell has, after the lapse of the
Offer Period, declared the Public Offer successful except for conditions that
are or become conditions subsequent, register
the changes of Berna’s articles of incorporation removing the provisions
restricting the transferability of the Berna Shares to 5% of the issued voting
rights, i.e., to abolish the 2nd sentence
of Article 5(2) and the Articles 5(3) and 5(4) in their
entirety, with the competent commercial register not later than until the end of the mandatory additional acceptance
period, and use all commercially reasonable endeavours to procure the fulfilment
of the condition to the Public Offer set out in Section (e) of Annex 2.3
(the amendments of the articles of incorporation
have been entered into the commercial re­gister) as soon as
possible.

4.3                                 If
the extraordinary meeting of the Berna shareholders convened as set forth in Article 4.1
does not approve the proposed changes to Berna’s articles of incorporation removing
the provisions restricting the transferability of the Berna Shares to 5% of the
issued voting rights, i.e., to abolish the 2nd sentence of Article 5(2) and
the Articles 5(3) and 5(4) in their entirety, the Berna Board shall,
after the 

 11
 

 

 

lapse of the
Offer Period, upon request by Crucell unless Crucell has declared the Public
Offer as failed, as promptly as possible convene a second extraordinary
shareholders’ meeting in order to procure the satisfaction of the conditions to
the Public Offer set out in Section (d) of Annex 2.3 (changes of Berna’s articles of incorporation  removing the provisions restricting the transferability of the Berna
Shares) and in Section (e) of Annex 2.3 (the amendments of the articles of incorporation have been entered into
the commercial register).

4.4                                 Berna
shall procure that the board representatives designated by Crucell shall be
proposed by the Berna Board to the extraordinary meeting of the shareholders
convened as set forth in Article 4.1 for election to the Berna Board,
subject to the Public Offer becoming unconditional. If the representatives
designated by Crucell are not validly elected to the Berna Board on or by the
settlement date of the Public Offer, the representatives designated by Crucell
shall be entitled to receive, as of such date, all information provided to
members of the Berna Board and to attend all meetings of the Berna Board with a
consulting vote. In addition, at the request of Crucell, the Berna Board shall
convene an extraordinary mee­ting of the shareholders with the agenda items
that Crucell may reasonably propose, including the election of new members of
the Berna Board.

4.5                                 Berna
shall procure that Crucell and its advisors are given due opportunity to
review, and comment on, the invitations to the meetings of the Berna sharehol­ders
and the resolutions submitted for its approval, and consult with Crucell on all
other relevant matters in connection with the meetings of the Berna sharehol­ders.

4.6                                 It
is the parties’ understanding that,
following the settlement of the Public Offer, the Berna Board will be composed of 7 directors, including the
3 directors designated by Crucell. The chairman shall be Peter Giger and the vice-chairman
Ronald Brus. In order to achieve this result, Ulrich Ammann, Peter Grogg, Jürg
Legler and Urs Schaad have resigned as members of the Berna Board subject to
the Public Offer becoming unconditional; copies of the duly signed resignation
declarations, received by Berna, are attached to this Agreement as Annex 4.6.

5.                                      Certain
Representations and Obligations of the Parties

5.1                                 Berna
hereby represents and warrants as of the date hereof that

5.1.1                        the
information set forth in Recital A is true and correct,

 

 12

 

5.1.2                        it has not
taken, proposed or approved, since June 15, 2005, any actions that have
any dilutive effect on the Berna Shares, except for the issuance of shares and
options under the ESOP and the ESPP respectively, as set forth in Annex A,

5.1.3                        except as
set forth in Annex A, none of the options granted under the ESOP
have been exercised,

5.1.4                        after due
inquiry it is not aware of any Berna Material Adverse Event with respect to
Berna Group,

5.1.5                        it is - in its reasonable judgement and after due inquiry -
not aware of any facts or circumstances (other than as contemplated
herein), including any issues related to patent litigation that have not been
adequately disclosed to or disseminated in the public and that could have, if
disclosed or disseminated, a material effect on the price of the Berna Shares,

5.1.6                        it is not
aware of any particular facts or circumstances, which could impair or prevent
the success of the Public Offer, Crucell’s interest in such Public Offer, or
the satisfaction of its conditions,

5.1.7                        the
shareholdings of Berna in its subsidiaries correspond to the group chart in Annex 5.1.7,

5.1.8                        other than
options, which are not exercisable until their lapse on December 31, 2005,
no options have been issued under the employee stock option plan of Green Cross
Vaccine Corporation and that there is no obligation of Green Cross Vaccine
Corporation for the issuance of such options,

5.1.9                        that
PricewaterhouseCoopers has issued a fairness opinion to Berna as set forth in Annex 5.1.9.

Immediately prior to each of (a) the publication of the
Pre-Announcement, (b) the publication of the prospectus of the Public
Offer and the documentation relating to the Crucell Exchange Share Offering and
(c) any subsequent publication of an amendment of the Public Offer, the
chairman and the CEO of Berna shall deliver to Crucell a certificate dated that
day confirming in writing, to the best of their knowledge, that the representations
set forth in this Article 5.1 are still true and correct as of such date
(or specifying in what respect they are no longer true and correct).

 13
 

 

5.2                                 Crucell
hereby represents and warrants to Berna as of the date hereof that

5.2.1                        the
information set forth in Recital B is true and correct,

5.2.2                        it has not
taken, proposed or approved, since June 15, 2005, any actions that have
any dilutive effect on the Crucell Shares, except for the issuance of shares
and options under its employee stock options plan, as set forth in Annex B,

5.2.3                        after due
inquiry it is not aware of any Crucell Material Adverse Event with respect to
Crucell Group,

5.2.4                        it is — in
its reasonable judgement and after due inquiry - not aware of any facts or
circumstances (other than as contemplated herein) that have not been adequately
disclosed to or disseminated in the public and that could have, if disclosed or
disseminated, a material effect on the price of the Berna Shares,

5.2.5                        it is not
aware of any particular facts or circumstances, which could impair or prevent
the success of the Public Offer, Berna’s interest in such Public Offer, or the
satisfaction of its conditions.

Immediately prior
to each of (a) the publication of the Pre-Announcement, (b) the
publication of the prospectus of the Public Offer and the documentation
relating to the Crucell Exchange Share Offering and (c) any subsequent
publication of an amendment of the Public Offer, the chairman and the CEO of
Crucell shall deliver to Berna a certificate dated that day confirming in
writing, to the best of their knowledge, that the representations set forth in
this Article 5.2 are still true and correct as of such date (or specifying
in what respect they are no longer true and correct).

5.3                                 The
parties shall disclose to each other anything, which will or may impair the
Public Offer or prevent any of the conditions to the Public Offer set out in Annex 2.3
from being satisfied, promptly upon such matter coming to their notice.

5.4                                 Subject
to any constraints under applicable law, the parties shall cooperate with each
other and give the other party, and its legal and financial advisors and auditors,
reasonable access to the management, legal and financial advisors, documents
and information to the extent this is reasonably requested by a party or its
advisors to conduct the actions reasonably requested or required (a) to
procure or verify the satisfaction of the conditions to the Public Offer, (b) to
prepare or 

 14
 

 

support any
filings to the Swiss takeover board or otherwise, (c) to prepare the
documentation and to support any filings in connection with the Crucell Exchange
Share Offering, (d) to perform any follow-up due diligence, and (e) to
enable a smooth transition.

5.5                                 Unless
(a) otherwise provided herein, or (b) resolved by a shareholders’
meeting of Berna (i) convened at the specific request of third party
shareholders holding 10% or more of the voting rights or (ii) if the
inclusion of the relevant item was added, at the request of shareholders holding
Berna Shares with a nominal value of CHF 1,000,000 or more, to the agenda
of a shareholders’ meeting convened by the Berna Board, and in both cases (i) or
(ii) the Berna Board recommended the rejection of the proposals made by
such shareholder, the Berna Board shall procure that the Berna Group continues
to operate its business as a going concern, in the ordinary course of business
and consistent with prior practice and the currently existing business plan at
all times from the date of this Agreement. Unless specifically provided in this
Agreement, the Berna Board shall procure that the Berna Group or any of its
members shall not, without prior consent of Crucell, which shall not be
unreasonably withheld or delayed (or, if applicable merger control laws do not
so permit, prior consultation of Crucell) do or agree to do any of the
following from the date of this Agreement:

5.5.1                        execute
any contracts that would inhibit or impair the consummation of the Public Offer
and the transactions contemplated und this Agreement;

5.5.2                        anything
which would constitute a Material Adverse Event;

5.5.3                        make any
material change in the terms of employment of any director, officer or employee
of the Berna Group other than in accordance with exis­ting agreements;

5.5.4                        alter or
amend in any manner the articles of incorporation of the Berna Group, safe as
required to procure satisfaction of the conditions to the Public Offer;

5.5.5                        issue or
create any obligation to issue any shares, options, conversion rights or other
securities in any member of the Berna Group, increase or reduce or otherwise
change the share capital or capital structure, or engage in any share splits
with respect to any member of the Berna Group;

5.5.6                        transfer
any assets or shares of any member of the Berna Group to a third party, other
than in the ordinary course of business;

 15
 

 

5.5.7                        enter
into, or increase or extend any liability under any guarantee or indemnity in
excess of CHF 500,000 per item other than in the ordinary course of
business but in any event not in excess of CHF 5,000,000 in the aggregate;

5.5.8                        increase
or extend any loan or advance or grant any credit to any third person in excess
of CHF 500,000 per item other than in the ordinary course of business but
in any event not in excess of CHF 5,000,000 in the aggregate;

5.5.9                        grant,
create or allow to be created any lien over any of the Berna Group’s assets
other than liens arising by operation of law or in the ordinary course of
business;

5.5.10                  borrow any money
or incur any indebtedness or other liability as against a third party in excess
of CHF 500,000 per item but in any event not in excess of
CHF 5,000,000 in the aggregate;

5.5.11                  declare, make or
pay any dividend or other distribution, payable in cash, stock, property or
otherwise;

5.5.12                  enter into,
amend, modify or terminate or consent to the termination of any shareholders’
agreement, joint venture, license, distribution and supply agreements, or
amend, waive, modify, terminate or consent to the ter­mination of any member of
the Berna Group’s rights thereunder, other than in the ordinary course of
business (it being understood that entering, amending, modifying or terminating
of any agreements of strategic importance shall not be deemed to be in the
ordinary of course of business);

5.5.13                  take any action
which is inconsistent with the obligations of a target company pursuant to Article 29(2) SESTA
or Articles 34 to 36 of the TOB Ordinance.

5.6                                 Berna
is aware and acknowledges that, as of the date of this Agreement, it and all
members of the Berna Group are considered as acting in concert with Crucell
with respect to the Public Offer in accordance with Article 11 TOB Ordinance.
As a result of such acting in concert, Berna shall, at all times from the date
of this Agreement until the day falling six months after the end of the
additional acceptance period of the Public Offer, comply with all the
obligations set out in Article 12(1) TOB Ordinance. Without
limitation to the generality of the foregoing Berna shall not, and shall
procure that neither the members of the Berna Group

 16
 

 

nor any person on their behalf shall:

5.6.1                        acquire,
or agree to acquire, any Berna Shares, or enter into any derivative transaction
in relation to Berna Shares; or

5.6.2                        change or
amend the terms and conditions of the existing ESOP and ESPP and the options
granted thereunder, or establish any new share option or participation plans,
with respect to Berna Shares.

5.7                                 Following
the settlement of the Public Offer, Berna shall support any commercially
reasonable actions proposed by Crucell in order to de-list the Berna Shares, to
achieve control over 100% of the Berna Shares or to prepare and facilitate the
combination and integration of the Berna Group with the Crucell Group,
including those contemplated in Articles 2.8 and 2.9.

5.8                                 The
parties agree that the initial management committee of Crucell post transaction
shall be as follows:

- CEO: Ronald Brus

- CFO: Leon
Kruimer

- CBO: Kuno Sommer

- CSO: Jaap
Goudsmit

- COO: Simon
Rothen

- Strategy &
Integration: John Lambert

- General Counsel
and Corporate Secretary: René Beukema

Ronald Brus, Leon
Kruimer, and Jaap Goudsmit are members of the management board of Crucell.

6.                                      ESOP
Options and ESPP Shares

6.1                                 Subject to the
settlement of the Public Offer, Crucell shall offer to the holders of ESOP
options not exercised on the date of the settlement of the Public Offer (provided
that, for avoidance of doubt, all options in-the-money may be exercised after
the Offer having been declared successful by Crucell until the end of the
mandatory additional offer period irrespective of their initial vesting period,
which shall be waived for such purpose by Berna) the exchange of such ESOP options
into substantially equivalent options for such number of Crucell shares cor­responding
to the Exchange Ratio or, if Crucell so chooses, the termination against an
adequate indemnification (at Crucell’s choice) in cash or in Crucell shares.
Such options for Crucell shares shall, if currently applicable, provide for 

 17
 

 

essentially the same vesting periods,
forfeiture clauses and other elements as the ESOP options. The strike price
shall be set at a level that will fairly reflect the value of the ESOP options
corresponding to the Exchange Ratio using a gene­rally accepted option
valuation formula. The holders of ESOP options shall in no event be entitled to
a consideration that could lead to an increase of the consi­deration to be paid
to the holders of Berna shares pursuant to the best price rule.

6.2                                 Tendering
holders of Berna Shares locked-in under the ESPP shall receive the
corresponding number of Crucell Shares corresponding to the Exchange Ratio, to
be delivered into the account of the holders free of any restriction under the
ESPP.

6.3                                 Concurrent
with the launch of the Public Offer, Berna shall waive vis-à-vis the relevant
holders of options under the ESOP and of Berna Shares under the ESPP the transfer restrictions if and to the
extent that such options or Berna Shares shall be transferred to Crucell in
connection with the Public Offer or as contemplated in this Article 6.

7.                                      Press
Releases and Other Public Announcements; Confidentiality

Following the
date of this Agreement, all public announcements or press releases issued in
connection with the Public Offer shall only be published after Crucell and
Berna shall have consulted and agreed on the contents of such public
announcements or press releases. Nothing in this Agreement shall restrict or
prohibit:

7.1                                 any
announcement or disclosure required by statutory law or by any competent
judicial or regulatory authority or by any competent securities exchange (in
which case the parties shall cooperate in good faith in order to agree on the
content of any such announcement prior to it being made);

7.2                                 Crucell
or Berna from making any disclosure to any of its directors, officers,
employees, agents or advisors who are required to receive such information to
carry out their duties (conditional upon any such person agreeing to keep such
information confidential for so long as the disclosing party is obligated to do
so in accordance with Article 7 or applicable law); or

7.3                                 Crucell
from publishing any filings, prospectuses, public announcements, statements or
press releases in connection with the Public Offer and the issuance of the
Crucell Exchange Shares as it considers appropriate.

 18
 

 

Sections 1, 2, 8 and 9 of the non-disclosure agreement concluded among
the parties on August 17, 2005 as amended on August 30, 2005, on October 31,
2005 and on November 29, 2005, shall continue to be valid and enforceable,
with all other obligations being terminated hereby. The surviving sections
shall, however, terminate, if the Public Offer is settled.

8.                                      Costs
and Expenses

8.1                                 Except
as expressly provided otherwise herein, each party shall bear its own costs and
expenses (including advisory fees) incurred in the negotiation, preparation and
completion of this Agreement.

8.2                                 Berna
agrees to pay to Crucell an amount of CHF 3.5 million as a liquidated
compensation of parts of the costs that Crucell and its advisors have incurred
or will incur for making and|or preparing the Public Offer if the Public Offer
does not become unconditional or is otherwise not successful because a
competing offer to the Public Offer is a Superior Offer (which shall inter alia be deemed the case for the
purposes of this clause if the competing bidder declares its offer successful
after the regular offer period).

The compensation payment shall become due and payable within 20 trading
days after any of the above events has occurred and Crucell has publicly declared
that the Public Offer has failed.

9.                                      Termination

9.1                                 This
Agreement may be terminated with immediate effect either by mutual written
consent of the parties or by giving notice in writing to the other party:

9.1.1                        by each
party if Crucell publicly declares that the Public Offer will not be further
pursued or has failed or if Crucell otherwise withdraws from launching,
continuing or settling the Public Offer (where permitted by the law and this
Agreement);

9.1.2                        by each
party if the other party materially breaches any representations or materially
violates its obligations under this Agreement, unless immediately and fully
remedied by the breaching party;

9.1.3                        by each
party if the Public Offer is not pre-announced on or before December 15,
2005 or is not launched within the periods provided by takeover law (or within
any extension granted by the Swiss takeover board);

 19
 

 

9.1.4                        by each
party upon the pre-announcement (in accordance with takeover law) or launch of
a Superior Offer unless Crucell (a) agrees in writing, within three trading days of such announcement or pre-announcement
to improve the terms and conditions of the Public Offer in a manner that the
competing offer no longer constitutes a Superior Offer, and (b) publicly
announces, by way of a press release or otherwise, such improvement of the
Public Offer on the fourth trading day following such pre-announcement or
launch of the Superior Offer (provided that, for the avoi­dance of doubt, the
formal publication of such change to the Public Offer may occur thereafter but
in any event on or by the latest date on which the publication of an amendment
to the Public Offer is permitted under Swiss takeover laws and regulations);

9.1.5                        by each
party if a competing offer to the Public Offer has an acceptance rate of 50% or
more of all voting rights and is declared successful by the competing bidder;

9.1.6                        by Berna
in case of a Crucell Material Adverse Event and by Crucell in case of a Berna
Material Adverse Event; or

9.1.7                        by Crucell
in case that the satisfaction of any of the conditions contemplated in Annex 2.3
have turned out to be impossible.

9.2                                 If
this Agreement is terminated according to Article 9.1, such termination
shall be without liability of any party to the other party (save as set out in Article 8.2,
which shall prevail); provided that if such termination shall result from the
breach by any party of its obligations under this Agreement, such party shall
be fully liable for all damages suffered by the other party and for costs
incurred that become futile as a result of such breach. For the avoidance of
doubt, except as set forth in this Agreement and unless this Agreement should
be terminated as provided in this Agreement, the parties shall be bound to
pursue and support the Public Offer, except if such obligation would be void
due to a violation of mandatory laws or for other reasons.

9.3                                 If
this Agreement is terminated as provided herein, all provisions of this Agreement
shall cease to be effective except as set forth in Article 7, last
paragraph (Confidentiality and Non-Solicitation)
and for Article 8 (Costs and Expenses),
Article 9 (Termination) and Article 10
(Governing Law and Arbitration).

 20
 

 

10.                               Governing
Law and Arbitration

10.1                           This
Agreement shall be governed by and construed in accordance with the sub­stantive
laws of Switzerland.

10.2                           All
disputes arising out of or in connection with this Agreement, including disputes
on its conclusion, binding effect, amendment and termination shall be resolved,
to the exclusion of the ordinary courts, by arbitration in accordance with the
Swiss Rules of International Arbitration of the Swiss Chambers of Commerce
in force on the date when the Notice of Arbitration is submitted in accordance
with these Rules. The number of arbitrators shall be three. Each party shall appoint
one arbitrator and the arbitrators so appointed shall appoint the chairman. The
seat of the arbitration shall be in Berne. The arbitral proceedings shall be
conducted in English. In addition, interim relief can be sought with any
competent court or authority.

 21
 

 

So agreed with effect as per the date first
above mentioned:

	
  Crucell N.V. 

  	
   

  	
   

  	
   

  	
  Berna Biotech AG 

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ronald Brus

  	
   

  	
  Leon Kruimer

  	
   

  	
  Peter Giger

  	
   

  	
  Juerg Witmer

  

 

 22Exhibit 4.10

18 June 2004

Berna Biotech Ltd

Rehhagstrasse 79

CH-3018 Bern

SWITZERLAND

Attention: Kuno Sommer, Chief Executive
Officer

Dear Kuno,

Letter of Amendment to Supply
Agreement

We refer to the Supply Agreement dated 12 November 2001
(the Agreement) between
CSL Limited (CSL)
and Berna Biotech Ltd (Berna) for the supply of Product on a worldwide
non-exclusive basis subject to specified Exclusive and Excluded Territories.

As discussed, it is proposed that the
Agreement be amended as follows:

1.                          Agreement
to Supply

Under clause 1.7, the Agreement pertains to
the supply of Product for Northern Hemisphere influenza vaccine manufacture by
Berna. Supply of Product for Berna to manufacture influenza vaccine for the
Southern Hemisphere will be the subject of a separate agreement if the parties
agree to proceed.

2.                          Term and
Termination

Under Schedule 1 item 2, the Initial Period of
the contract is extended by two years to end on 31 December 2009.

3.                          Supply
of Product(s) against Orders

a)                        Under
Clause 3.1. Berna is to provide in November each year a five-year
indicative forecast to be discussed at a face to face meeting. At that meeting
CSL will confirm whether it expects to be able to supply the forecasted
quantity of Product and make adjustments to the indicative non-binding maximum
quantities for the five year forecast period.

 

 

As at the date of this
letter, the quantities outlined in the five-year indicative forecast and up to
the maximum quantities are as follows:

	
  Year

  	
   

  	
  Total GM HA

  	
   

  	
  25 mcgm doses

  
	
  2005

  	
   

  	
   

  	
   

  	
   

  
	
  2006

  	
   

  	
   

  	
   

  	
   

  
	
  2007

  	
   

  	
   

  	
   

  	
   

  
	
  2008

  	
   

  	
   

  	
   

  	
   

  
	
  2009

  	
   

  	
   

  	
   

  	
   

  

CSL shall use its best
efforts to be able to supply to Berna the quantities outlined in the five-year
indicative forecast and up to the maximum quantities as follows:

	
  Year

  	
   

  	
  Total GM HA

  	
   

  	
  25 mcgm doses

  
	
  2005

  	
   

  	
   

  	
   

  	
   

  
	
  2006

  	
   

  	
   

  	
   

  	
   

  
	
  2007

  	
   

  	
   

  	
   

  	
   

  
	
  2008

  	
   

  	
   

  	
   

  	
   

  
	
  2009

  	
   

  	
   

  	
   

  	
   

  

Berna will, before 30 June each
calendar year provide CSL with a written best estimate of its supply
requirements for the Product for the subsequent year. Within 8 weeks CSL is to
notify Berna whether CSL will be able to supply the forecasted quantity of
Product for the following season based on expected strains and yields. Berna
may, before 30 November each year, submit to CSL a revised best estimate
of its supply requirements.

b)                       Under
clause 3.3, each order placed by Berna will be for a minimum quantity of HA for
each calendar year as follows:

	
  Year

  	
   

  	
  Total GM HA

  	
   

  	
  25 mcgm doses

  
	
  2005

  	
   

  	
   

  	
   

  	
   

  
	
  2006

  	
   

  	
   

  	
   

  	
   

  
	
  2007

  	
   

  	
   

  	
   

  	
   

  
	
  2008

  	
   

  	
   

  	
   

  	
   

  
	
  2009

  	
   

  	
   

  	
   

  	
   

  

CSL confirms and Berna
understands and accepts that payment in full is required for the minimum
quantity, regardless of whether the minimum quantity is ordered/purchased.

c)                        Under
clause 3.4, each of Berna’s orders for Product shall be in writing and shall constitute
a binding order upon CSL. Insofar as Berna requires quantities exceeding those
mentioned in Berna’s November best estimate CSL shall use reasonable
efforts to deliver such quantities.

4.                          Price
and Payment

a)                        Under
clause 4.1 the Product(s) will be invoiced at the prices set out in
Schedule 2. The price will be based on the number of eggs used to manufacture
the quantity of Product ordered and delivered to Berna. The amount due per egg
used will for the year 2005-2009 be as follows:

	
  2005

  	
   

  	
  A$        per egg

  
	
  2006

  	
   

  	
  A$        per egg

  
	
  2007

  	
   

  	
  A$        per egg

  
	
  2008

  	
   

  	
  A$        per egg

  
	
  2009

  	
   

  	
  A$        per
  egg

  

 

	
  Phone: +61 3 9389 1769

  	
   

  	
  CSL Limited ABN
  99 051 588 348

  45 Poplar Road Parkville Victoria 3052 Australia

  June.McKay@csl.com.au

  	
   

  	
  Fax: +61
  9389 1076

  

 

 2
 

 

 

b)                       Under Schedule 2 the 2005 calendar year
price for a trivalent dose (25 mcgm of each strain) will be based on an amount
of A$      per
egg used to manufacture the quantity of Product(s) delivered to Berna. The
relationship between price per egg used to manufacture the Product and actual
price paid per 25 mcgm HA of each strain is dependant upon the egg yield. Using
the five year average yield the price of
A$       per egg used relates to A$       per 25 mcgm trivalent dose. With better than average yields the price
per dose reduces because the processing cost is fixed, as shown in the table
below:

	
  Yield_

  	
   

  	
  Yield Per Egg

  (mcgm/egg)

  	
   

  	
  Price / Egg

  	
   

  	
  Price per

  25mcgm dose

  
	
  10% above average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5 year average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10% below average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

Note: the above yields are indicative only.
The actual yield could be greater or less than ±10% from the five-year average.

5.                          Product
Recall

Under clause 19.1 Berna will inform CSL
immediately by telephone or facsimile transmission (immediately confirmed in
writing) in the event of any circumstances giving rise to a possible or actual
recall of Finished Influenza Vaccine containing the Product(s) where the
recall is alleged to be due to Product(s). CSL will inform Berna immediately by
telephone or facsimile transmission (immediately confirmed in writing) in the
event of any circumstances giving rise to a possible or actual recall of any
batches of the Product(s) delivered to Berna.

Clauses 19.2, 19.3 and 19.4 will continue in
full force and effect.

6.                          Adverse
Drug Events

Clause 20.2 and 20.5 and Schedule 4 shall be deleted without
replacement. Clause 20.1, 20.3 and 20.4 are changed as follows and will replace
the previous provisions:

a)                        Under
clause 20.1 CSL and Berna shall keep each other informed on all reports of
Adverse Drug Events (ADE) coming to either party’s knowledge with regard to the
Product(s) regardless of the origin of such reports. The term Reports shall
also include publications in journals and other media. If Berna receives any
ADE report which is both serious and unexpected and alleged to be caused by the
Product(s) Berna will report the matter to the Registration Authority in
compliance with the laws and regulations in the Territory.

b)                       Under
clause 20.3 Berna will give immediate written notice to CSL of any alleged
manufacturing or other defect in the Products(s) of which Berna becomes
aware and of any possible expense, liability, cost, claim or proceeding arising
from the alleged defect.

c)                        Under
clause 20.4 Berna will not make any admission of liability to any third party
with respect to claims either in the name of Berna or on behalf of CSL with
respect to any adverse experiences alleged to be caused by, and any alleged
manufacturing or other defects in the Product(s) without CSL’s prior
written consent.

Terms used in this letter shall have the same meaning as defined in the
Agreement unless the context requires otherwise. Except as amended by this
letter, the terms of the Agreement remain in full force and effect.

	
  Phone: +61 3 9389 1769

  	
   

  	
  CSL Limited ABN
  99 051 588 348

  45 Poplar Road Parkville Victoria 3052 Australia

  June.McKay@csl.com.au

  	
   

  	
  Fax: +61
  9389 1076

  

 

 3
 

 

 

Please confirm Berna’s
formal agreement to the above by signing and returning the enclosed copy of
this letter.

Yours sincerely

	
  /s/ Zita
  Cunningham

  	
   

  	
   

  
	
   

  	
   

  	
   

  

 

Zita Cunningham

Business Development Director, Pharmaceuticals Group

Accepted and agreed for
and on behalf of Berna Biotech Ltd by its duly authorised representative(s):

	
  Illegible, 24 June 2004

  	
   

  	
  /s/ Jorg von Manger-Koenig

  
	
  Place, date

  	
   

  	
  Name:

  	
  Jörg
  von Manger-Koenig

  
	
   

  	
   

  	
  Function:

  	
  Executive Vice President Legal,

  Regulatory Affairs & IP

  
	
   

  	
   

  	
   

  	
   

  
	
  Illegible,
  24.06.04

  	
   

  	
  /s/ Dr. Alexandra Fischer-Hauck

  
	
  Place, date

  	
   

  	
  Name:

  	
  Dr. Alexandra Fischer-Hauck

  
	
   

  	
   

  	
  Function:

  	
  Director, Global Product Management

  

 

	
  Phone: +61 3 9389 1769

  	
   

  	
  CSL Limited ABN
  99 051 588 348

  45 Poplar Road Parkville Victoria 3052 Australia

  June.McKay@csl.com.au

  	
   

  	
  Fax: +61 9389
  1076

  

 

 4

 

THIS SUPPLY
AGREEMENT is made on the date last signed

	
  BETWEEN:

  	
   

  	
  CSL LIMITED ACN 051 588 348

  45 Poplar Road, Parkville, Victoria, Australia 3052

  Facsimile: (+613) 9389 1434

  	
   

  	
  (CSL)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AND:

  	
   

  	
  BERNA BIOTECH LTD

  Rehhagstrasse 79, CH-3018 Berne, Switzerland

  Facsimile: (+41) 31 980 62 29

  	
   

  	
  (BERNA)

  

WHEREAS:

A.                      CSL is
engaged in the manufacture and distribution of human and veterinary pharmaceutical
and diagnostic products.

B.                        BERNA is
active in the manufacturing, distribution and marketing of similar products.

C.                        BERNA
wishes to obtain from CSL and CSL wishes to supply to BERNA Bulk Inactivated
Whole Virus Influenza Concentrate — Monovalent Pooled Harvest as set out in
this Agreement.

THE PARTIES AGREE

1.                         Agreement
to Supply

1.1                    CSL agrees to
supply, and BERNA agrees to purchase, Product(s) on the terms and
conditions set out in this Agreement.

1.2                    This Agreement
will oblige CSL to manufacture or (if it is not able to manufacture by
decisions of the authority
concerned) to deliver the Product(s) as ordered by BERNA and accepted by
CSL.

1.3                    Nothing in
this Agreement will restrict BERNA’s ability to deal in bulk influenza vaccine
(other than the Product) and Finished Influenza Vaccine formulated with the
Product or other vaccines utilising Virosome technology formulated with the
Product except that BERNA agrees not to sell such vaccines to any third party
where BERNA knows that same may be used within the Excluded Territory.

1.4                    BERNA will not
use the Product(s) in any way other than as permitted under this
Agreement. In particular, BERNA will use the Product(s) only as a bulk
component in the formulation of Finished Influenza Vaccines and other vaccines
utilising Virosome technology.

1.5                    Nothing in
this Agreement will restrict CSL’s ability to deal in bulk influenza vaccine
and Finished Influenza Vaccines except that CSL agrees not to sell Finished
Influenza Vaccines to any third party where CSL knows that same may be used
within the Exclusive Territory. BERNA may on or before 30 June 2002
request that the Exclusive Territory be expanded and CSL will notify BERNA of
its agreement or otherwise to such expansion on a country by country basis by
30 September 2002.

1.6                    Regarding new
influenza products developed by BERNA, BERNA agrees to consider CSL as a
distributing partner for the Excluded Territory.

1.7                    BERNA is
interested to purchase Product(s) for the Southern Hemisphere and CSL
agrees to consider BERNA’s request prior to 21 December 2001. If CSL
notifies BERNA that CSL is willing to supply such Product(s), CSL and BERNA
will negotiate in good faith an amendment to this Agreement to provide for the
supply of such Product(s).

 1
 

 

 

3.                         Supply of
Product(s) against Orders

3.1                     BERNA will,
as soon as practicable after the Commencement Date, provide CSL with a written
best estimate of its supply requirements for each of the Product(s) for the
2002 calendar year. BERNA will, before 30 June each calendar year, provide
CSL with a written best estimate of its supply requirements for each of the
Product(s) for the subsequent calendar year. BERNA may, before 30 November each
year, submit a revised written best estimate of its supply requirements for
each of the Product(s) for the subsequent calendar year.

3.2                    On or before 28 February, BERNA will place a
firm written order with CSL for BERNA’s requirement for Product(s) for the
upcoming season. BERNA’s order must be for at least 75% of its 30 June written
best estimate provided under clause 3.1.

3.3                    Each order
will be for a minimum quantity of 100 gm HA per strain for the 2002 calendar
year, 150 gm HA per strain for the 2003 calendar year and for each subsequent
calendar year a scaled up minimum quantity will be agreed between CSL and Berna
based on the agreed European SRID assay.

3.4                    Each order
will be binding upon CSL unless within 14 days of receipt of an order CSL
notifies BERNA that it does not accept the order in excess of the minimum
quantity determined under clause 3.3.

3.5                    Delivery dates
for the Product(s) for the Northern Hemisphere will be based on yield and
CSL will use its best endeavours to advise BERNA of estimated delivery dates by
15 March. CSL will provide written confirmation of delivery dates by 30 April,
which will include any delivery date after 15 July. CSL will use reasonable
endeavours to deliver at least 11.5gmHA of each strain by 30 April for
regulatory requirements. If BERNA require a commercial delivery prior to 15 June 2002,
CSL will only commit to deliver 75% of the quantity ordered by Berna and
accepted by CSL. CSL will use reasonable endeavours to deliver the balance of
the accepted order by July 15.

3.6                    If CSL
delivers Product(s) in excess of BERNA’s firm order, BERNA must advise CSL
in writing of the quantity held in excess as soon as such excess is determined.
BERNA will process the excess quantity and store it for potential use in the
following Northern Hemisphere season. If the excess quantity is able to be used
in the following seasons, BERNA will pay CSL for the excess quantity at the
price applicable at the time of delivery within 30 days of the official
announcement of Northern Hemisphere strain selection. If the excess quantity is
unable to be used in the following season, BERNA will destroy the excess
quantity and notify CSL in writing that the excess quantity has been destroyed.

3.7                    CSL will use
its reasonable endeavours to supply the Product(s) in accordance with
BERNA’s orders. However, CSL’s liability for any loss or damage which BERNA may
suffer or incur as a result of CSL’s failure to supply the Product(s) in
accordance with accepted BERNA orders will be limited to the value of the
accepted order (or part thereof) which CSL fails to supply. If CSL delivers
Product(s) for the Northern hemisphere to another customer and fails to
deliver the accepted Berna order (or part thereof), CSL is liable for any loss
or damage Berna may suffer as a result of unfilled Berna customer orders.

3.8                    An indicative
timing program for ordering and price negotiations is set out in Schedule 3.

4.                         Price and
Payment

4.1                    The Product(s) will
be invoiced at the prices set out in Schedule 2. For the 2002 calendar year the
price will be based on an amount of A$          per
egg used to manufacture that quantity of product delivered to Berna. For the
2003 calendar year the price will be based on an amount of          and
for 2004 calendar year the price will be based on an amount of          .
The parties will negotiate in
good faith a new price for the 2005 calendar year and the 2006 calendar year
prior to 30 April 2004. The parties will take into account any change in
CSL’s manufacturing costs and the general influenza market conditions. If this
agreement is renewed, the

 2
 

 

 

parties will negotiate in
good faith a new price for the renewal period prior to 30 April of the
calendar year immediately prior to the initial year of the renewal term. The
parties will take into account any change in CSL’s manufacturing costs and the
general influenza market conditions.

4.2                    Unless
otherwise agreed in writing all payments will be made under the terms and in
the currency set out in Schedule 2.

4.3                    If the
closing price of the whole market spot rate for the Australian Dollar relative
to the Swiss Franc as reported in The Australian Financial Review deviates by
more than 10% from the closing price for the wholesale market spot rate
reported in The Australian Financial Review on the Commencement Date, the
parties agree to adjust any amounts due under this Agreement so as to ensure that
each party bears 50% of the exposure created by the deviation. Any further
deviation of more than 10% following any adjustment will result in a further
adjustment on the same terms.

5.                         Packing,
Delivery and Risk in Transit

5.1                    CSL will sell
the Product(s) ExWorks (lncoterms 2000), CSL’s Premises. CSL will pack the
Product(s) suitable for delivery to BERNA’s site in Berne, Switzerland.

5.2                    [Intentionally
Deleted]

5.3                    If CSL agrees
to arrange delivery on behalf of BERNA (beyond CSL’s obligations under clause
5.1) then the cost of freight and insurance arranged by CSL will be to BERNA’s
account, and CSL will be acting as BERNA’s forwarder. BERNA will indemnify and
keep indemnified CSL against all actions, claims, demands, losses, damages,
costs (including legal costs on a full indemnity basis) and expenses for which
CSL may become liable which relate directly or indirectly to CSL’s acting as
BERNA’s forwarder under this clause.

5.4                    Subject to
product liability under clause 13, CSL’s obligations under clause 5.1 and the
quality control and acceptance procedures, risk in the Product(s) will
pass to BERNA upon ExWorks delivery. Property and ownership of the Product(s) will
pass to BERNA upon payment.

6.                         Quality
Control

6.1                    CSL will
supply Product(s) free of defects in materials and manufacture, and in
compliance with the Specification and any Conditions of Registration (including
protocols to EU-regulations) set by the Registration Authority of which BERNA
has given CSL reasonable prior written notice.

6.2                    CSL and BERNA
will enter into a GMP Agreement, which is to be reviewed annually on or before
30 November, that is to be consistent with terms of this Agreement.

6.3                    CSL will keep
proper records and reference samples of all of its manufacturing and quality
control activities performed under this Agreement. CSL will provide, on
request, to Berna a copy of CSL’s current TGA certificate. BERNA may audit such
records and the production facilites at reasonable intervals, on reasonable
notice during normal business hours.

6.4                    CSL will
notify BERNA of any special storage requirements for the Product(s).

6.5                    BERNA will
store the Product(s) in suitable storage facilities having regard to both
the Specification and Conditions of Registration and in a manner which ensures
proper rotation of stock.

6.6                    BERNA will
test samples of delivered Product(s) and if it believes a particular
Product(s) (hereinafter referred to as “the Notified Product”) does not
comply with clause 6.1, it will notify CSL advising the batch number. CSL will examine
and test from that batch a sample retained by it (hereinafter referred to as “the Batch Sample”). If CSL finds the
Batch Sample does not comply with clause 6.1 then CSL will if practicable
replace the Notified Product in due time and after discussion with BERNA.

 3
 

 

 

6.7                    If CSL finds
the Batch Sample does comply with clause 6.1 and BERNA, based on its own
results, does not accept CSL’s findings, then a mutually agreed independent
testing agency will make a final decision with regard to the release specification
of the Notified Product, and that finding will be conclusive for the two parties. If it supports CSL findings
it is evidence for all purposes that the Notified Product complied with in
clause 6.1 when loaded for delivery at CSL’s premises. CSL will not be liable
to replace or allow a credit in respect of the Notified Product. The alleged
failure of the Notified Product to comply with clause 6.1 will be deemed to
have arisen or been caused by reason of an act or default of a person (not
being CSL or an employee or agent of CSL) or a cause independent of human
control occurring after the Notified Product was loaded for delivery at CSL’s
premises. If the releasing authority’s findings do not support CSL’s findings
the Product(s) CSL will if practicable replace the Notified Product in due
time and after discussion with BERNA. The cost of the independent testing
agency will be shared equally by CSL and BERNA regardless of the outcome.

7.                         BERNA’s
and CSL’s Duties and Obligations

7.1                    BERNA will:

(a)                    only distribute
and sell Finished Influenza Vaccine and other vaccines utilising Virosome
technology containing the Product(s) as agreed under this Agreement

(b)                   comply with all
laws, ordinances, regulations, rules and administrative directions
applicable to or governing or controlling the importation of the Product(s) into,
and the sale and use of the Product(s) in, the Territory

(c)                    notify CSL of
any reason BERNA has to believe that a particular Product(s) does not
comply with clause 6.1 as soon as possible and preferably within fourteen days
of that reason coming to the attention of BERNA. The notification will identify
the particular Product’s batch number. BERNA will also notify CSL of any
Adverse Drug Events under clause 20.

7.2                    BERNA and CSL
will ensure that their respective employees, agents and dealers are acquainted
with the obligations imposed by this Agreement to the extent reasonably
necessary to ensure compliance with the Agreement.

 4
 

 

 

8.                         Promotion
and Marketing

8.1                    BERNA will
have the absolute unilateral right to determine its promotion and marketing
activities, and the prices at which it will sell the Finished Influenza Vaccine
containing the Product(s) and to determine payment arrangements with
purchasers of the same. CSL does not desire to participate and will not
participate in any price determinations.

9.                         Provision
of Technical Information

9.1                    CSL, at its
expense, and as soon as practicable after the Commencement Date, will make
available to BERNA all technical information relating to the Product(s) which
CSL considers relevant to the reasonable needs of BERNA under this Agreement
and to the extent CSL has the right to divulge the information. Nothing in this
Agreement other than the required responses to the Registration Authority will
oblige CSL to make available to BERNA any information, technical or otherwise,
which is in any way referable to the manufacture, formulation, production or
processing of the Product(s).

9.2                    BERNA may
use any technical information made available to it pursuant to this clause but
only for the proper discharge of its obligations. BERNA will not use any of the
technical information made available to it for any purpose after this Agreement
ends. For Confidential Material see clause 12.

10.                  [Intentionally
Deleted]

11.                  Registration
Requirements

11.1              BERNA will effect,
in its own name and at its expense, any necessary registrations of the Product(s) in
the Territory. BERNA will provide CSL with all data and information and copies
of all documentation to enable CSL to comply with its obligations under this
Agreement.

11.2              CSL will assist
BERNA with dossier preparation, at BERNA’s cost. CSL and BERNA will consult and
agree on all dossier requirements (updates) and CSL’s costs by 30 November each
year for the following calendar year.

12.                  Confidentiality

12.1              Each party will:

(a)                    keep all
Confidential Material disclosed to it by the other party confidential;

(b)                   not permit the
other party’s Confidential Material to be disclosed other than in confidence to
its employees to the extent strictly necessary for the purposes of this
Agreement;

(c)                    use the other
party’s Confidential Material only for the purpose of this Agreement and not to
use for any commercial purpose other than under a further agreement with the
other party;

(d)                   not copy or
reduce to writing the other party’s Confidential Material except as reasonably
necessary for the purposes of this Agreement. Copies or reductions to writing
of Confidential Material of the other party shall be owned by that party;

(e)                    maintain the
other party’s Confidential Material in a way which provides adequate protection
from unauthorised disclosure, copying or use;

(f)                      indemnify
and keep indemnified the other party against all actions, claims, demands,
losses, damages, costs and expenses for which the other party may become liable
which arise as a result of an unauthorised disclosure of the other party’s
Confidential Material; and

 5
 

 

 

(g)                   return promptly
to the other party all documents
and materials (and all copies thereof) containing the other party’s
Confidential Material at the end of this Agreement.

12.2              “Confidential
Material” means all proprietary information disclosed by, or on behalf of, one
party to the other party relating to this Agreement and includes:

(a)                    information
disclosed in writing, verbally or by any other means,

(b)                   information
disclosed before, after or on the Commencement Date; and

(c)                    information
relating to the other party’s operations, processes, plans, intentions,
production information, know-how, data, formulae, expertise, methodology,
drawings, specifications, design rights, trade secrets, market opportunities
and business affairs, and any new and novel combinations thereof.

but excludes information which the receiving party
proves:

(d)                   is in or has
come into the public domain in any way without it breaching this Agreement;

(e)                    it has
developed independently as a result of its operations and activities;

(f)                      it has
obtained or has available from a source other than the disclosing party without
breach of any obligation of confidentiality or non-use;

(g)                   it knew prior
to being disclosed by the disclosing party; or

(h)                   it has
disclosed with the prior written approval of the disclosing party.

12.3              Either party may
disclose the other party’s Confidential Material in confidence to the
Registration Authority to the extent required to comply with the law and its
obligations under this Agreement.

13.                  Product
Liability

13.1              CSL will indemnify
and keep indemnified BERNA against all actions, claims, demands, losses,
damages, costs (including legal costs on a full indemnity basis) and expenses
for which BERNA may become liable which relate directly or indirectly to the
Products, their uses or effects but only to the extent arising from a breach of
this Agreement (including failure of Product(s) to comply with the
Specifications) by, or the negligence or wilful default of, CSL.

13.2              BERNA will indemnify
and keep indemnified CSL against all actions, claims, demands, losses, damages,
costs (including legal costs on a full indemnity basis) and expenses for which
CSL may become liable which relate directly or indirectly to BERNA’s altered
Product in any form, whether bulk, finished or otherwise, their uses or effects
except to the extent arising from any breach of this Agreement by, or the
negligence or wilful default of, CSL.

14.                  Term and
Termination

14.1              This Agreement will
begin on the Commencement Date and remain in effect during the Initial Period.
It will thereafter be renewed for successive two year periods until terminated.

14.2              Either party may
terminate this Agreement on 12 months notice to end at the end of the Initial
Period or any successive two year period thereafter.

14.3              The
party not affected may terminate this Agreement by giving to the other party
written notice to terminate on the date specified in the notice if:

 6

 

 

(a)                    a party fails
to rectify any breach of its obligations within 30 days of receiving a written
notice requiring it to do so;

(b)                   if a party
becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial
settlement with its creditors, makes an assignment for the benefit of its
creditors, voluntarily files for bankruptcy or has a receiver or trustee (or
the like) in bankruptcy appointed over its business, property or assets, or
becomes the subject of liquidation or dissolution (except for reconstruction
purposes such as mergers, etc) or involuntary bankruptcy proceedings or
otherwise discontinues business;

(c)                    any other
right of termination in favour of the first party arises under this Agreement;
or

(d)                   a change in
effective control of the other party.

14.4              If an important
parameter changes so materially that the continuation of this agreement would
lead to a material adverse financial effect for a party, that party may by
written notice request a negotiation in good faith to amend the terms of this
Agreement to address the change in that parameter. If the parties are unable to
agree on an appropriate amendment within three months of the date of the
notice, either party may terminate this Agreement by immediate written notice.
Such termination will not affect firm commitments made in connection with the
supply of Product(s) for the upcoming Northern Hemisphere influenza
season.

14.5              Termination will not
affect any other rights or obligations which may have accrued prior to
termination.

14.6              At the end of this
Agreement BERNA will promptly forward to CSL, at BERNA’s expense, all technical
information relating to this Agreement it received from CSL BERNA will not keep
any copies.

15.                  General

15.1              No waiver of any
provision of this Agreement will be of any force or effect unless confirmed in
writing, signed by the parties. Then such waiver will be effective only to the
extent for which it is made.

15.2              The invalidity or
unenforceability of any provision of this Agreement will not affect the validity
and enforceability of all other provisions which are self-sustaining and
capable of separate enforcement.

15.3              This Agreement
constitutes the entire agreement and understanding between the parties with
respect to its subject matter. It replaces all previous agreements between, or
undertakings by either of, the parties with respect to its subject matter.

15.4              This Agreement can
only be changed by written agreement of the parties.

15.5              Unless expressly
provided elsewhere in this Agreement, the relationship between the parties is
that of independent parties and will not be deemed to be that of
principal/agent, joint venture, partnership or otherwise.

15.6              The laws of
Victoria, Australia will govern this Agreement.

15.7              Clauses 11,
12,13,14.5 and 17.1 will continue to apply after this Agreement ends.

15.8              Neither party will
be liable for any failure or delay in the performance of its obligations under
this Agreement to the extent that such failure or delay arises from any
circumstance beyond its control including any Acts of Nature, strikes,
lock-outs, labour disputes or in the event of an influenza pandemic in the
Excluded Territory. Where such failure or delay continues for a continuous
period exceeding six months, the party not experiencing such failure or delay
may terminate this Agreement

 7
 

 

 

without penalty by written notice. The parties
acknowledge that manufacturing and formulation of the Product(s) and
Finished Influenza Vaccine is an extremely time sensitive business and
therefore agree to notify each other as early as possible of any failure or
delay under this clause 15.8.

15.9              Each party will bear
its own legal costs and expenses of and incidental to the preparation of this
Agreement.

15.10        This Agreement will bind
and enure for the benefit of the parties and their respective successors in
title. Neither party may assign any of its rights and obligations without the
prior written consent of the other party.

16.                  Notices

16.1              Any written notice
required under this Agreement must meet all of the following

(a)                    be given by
pre-paid post, personal delivery or facsimile transmission;

(b)                   be sent to the
contact address or facsimile number given above (or any other point previously
advised in writing by the recipient), and

(c)                    be marked to
the attention of a signatory to this Agreement (or any other person previously
advised in writing by the recipient).

16.2              No written notice is
to be effective until received, or deemed to be received by the other party as
follows:

(a)                    in the case of
personal delivery, upon delivery;

(b)                   in the case of
a letter, on the fifth business day after posting; and

(c)                    in the case of
a facsimile transmission, on the business day on which it is despatched, or, if
despatched on a non-business day, or after 5 pm on a business day then on the next
business day after day on which it is despatched. A record from the despatching
facsimile machine detailing the time and date of the transmission will be
evidence of transmission, unless proved to the contrary.

Times and business days will be determined according
to the place of receipt.

17.                  Arbitration

17.1              All disputes arising
under this Agreement will be finally settled under the Rules of
Conciliation and Arbitration of the International Chamber of Commerce in
Zurich, where CSL initiates the action, or in Melbourne, where BERNA initiates
the action, by one or more arbitrators appointed in accordance with those
Rules. All arbitrations will be conducted in the English language.

18.                  Benefit of
Indemnities

18.1              For the avoidance of
doubt, it is agreed that where a party agrees to indemnify the other, the
indemnified party will be or be deemed to be acting as agent for and on behalf
of and for the benefit of all persons who are or might be its directors,
officers, employees, consultants or agents from time to time and all such
persons will to this extent be or be deemed to be parties to this Agreement.

19.                  Product Recall

19.1              BERNA will inform
CSL immediately by telephone or facsimile transmission (immediately confirmed
in writing) in the event of any circumstances giving rise to a possible or
actual recall of any Finished Influenza Vaccine containing the Product(s). CSL
will inform BERNA immediately by telephone or

 8
 

 

 

facsimile transmission (immediately confirmed in
writing) in the event of any circumstances giving rise to a possible or actual
recall of any batches of the Product(s) delivered to BERNA.

19.2              CSL has the right
(irrespective of any power granted by law to the Registration Authority or
other authority in the Territory) on the grounds of public health and safety to
require BERNA to evaluate and in case to discontinue sale of and recover some
or all batches of Finished Influenza Vaccine containing the Product(s) specified
by CSL. If BERNA does not so discontinue sale, any sales made after the date of
CSL’s request under this clause 19.2 will be made solely at BERNA’s own risk
and the indemnity in clause 13.1 will not apply.

19.3              Where a product
recall has been initiated whether by the Registration Authority or other
authority in the Territory or by BERNA or CSL under clause 19.2 BERNA will inform all purchasers of the
Product(s) so affected and shall require them to deliver or make available
for collection all such stocks of Finished Influenza Vaccine containing the
defective Product(s) in their possession. BERNA will ensure that all such
stocks of Finished Influenza Vaccine containing the defective Product(s) are
collected and stored in secure conditions on premises controlled by BERNA.

19.4              Costs of any action
taken under this clause 19 will be borne by BERNA unless the costs are caused
by the breach of this Agreement, (including failure of Product(s) to
comply with the Specifications) by, or negligence or wilful default of, CSL, in
which case CSL will indemnify BERNA against any and all actions, claims,
demands, losses, damages, costs and expenses for which BERNA may become liable
which arise from such breach, negligence or wilful default.

 9
 

 

 

20.                  Adverse Drug
Events

20.1              If BERNA receives
any Adverse Drag Event (ADE) report which is both serious and unexpected and
alleged to be caused by Finished Influenza Vaccine containing the Product(s) BERNA
will report the matter according to Schedule 4 to the Registration Authority in
compliance with the laws and regulations of the Territory, and inform CSL
without delay by telephone or facsimile transmission (immediately confirmed in
writing). CSL will acknowledge receipt within 24 hours by facsimile
transmission.

20.2              BERNA will report to
CSL by telephone or facsimile transmission (immediately confirmed in writing)
any other adverse experience occurring in the Territory and alleged to be
caused by Finished Influenza Vaccine containing the Product(s) every three
months.

20.3               BERNA will give
immediate written notice to CSL of any alleged manufacturing or other defect in
the Product(s) or Finished Influenza Vaccine containing the Product(s) of
which BERNA becomes aware and of any possible expense, liability, cost, claim
or proceedings arising from the alleged defect.

20.4              With respect to any
adverse experiences alleged to be caused by, and any alleged manufacturing or
other defects in, the Product (s)
or Finished Influenza Vaccine containing same BERNA will not make any admission
of liability to any third party with respect to claims either in the name of
BERNA or on behalf of CSL without CSL’s prior written consent.

20.5              For the purpose of
this clause 20, “serious” and “unexpected” will have the meaning ascribed to it
at the relevant time by the Registration Authority or as otherwise notified by
CSL from time to time.

21.                  Definitions and
Interpretation

21.1              In this Agreement:

(a)                    Batch Sample is defined in clause 6;

(b)                   Commencement Date means 1 November 2001;

(c)                    Confidential Material is defined in clause 12;

(d)                   CSL’s Premises means CSL’s premises at 45 Poplar Road, Parkville,
Victoria, Australia, 3052 or suet other address notified to BERNA in writing by
CSL;

(e)                    Exclusive Territory means the territory set out in Item 1A of
Schedule 1;

(f)                      Excluded Territory means the territory set out in Item IB
of Schedule 1;

(g)                   Finished Influenza Vaccine means product that is intended for the
prevention of influenza only and is formulated, filled in final container and
packed;

(h)                   GMP Agreement means an agreement which specifies the
Australian Code of Good Manufacturing responsibilities relating to the
manufacture of the Product(s);

(i)                       ha  means haemaglutinin

(i)                       Initial Period means the period set out in Item 2 of
Schedule 1;

(i)                       Notified Product is defined
in clause 6;

(j)                       SRID means the single radial immunodifusion;

 10
 

 

(k)                    Territory means the
territory set out in Item IA of Schedule 1;

(l)                       Product means the
product set out in Schedule 2;

(m)                 Registration Authority means Swiss
Federal Office of Public Health or any other body responsible for the
registration of the Product(s) in the Territory from time to time;

(n)                   Specification means the Product Specification set out
in Schedule 2; and

(o)                   Virosome means virus-like particles consisting of
artificial bilayer liposomes with integrated viral surface antigens imitating a
virus as developed and used by BERNA;

21.2.           In this Agreement:

(a)                    Words denoting
the singular number include the plural number and vice versa;

(b)                   Words denoting
any gender include all genders;

(c)                    References to
persons include bodies corporate and vice versa;

(d)                   Words defined
in another part of this Agreement will have the meaning given in that part;

(e)                    References to
Recitals, clauses, sub-clauses, Schedules and Annexures are references to
Recitals, clauses, sub-clauses, Schedules and Annexures of or to this Agreement;

(f)                      References
to the parties include references to respective directors, officers, employees
and agents of the parties; and

(g)                   Headings are
inserted for convenience only and will not affect interpretation.

22.                  Enclosures

	
  Schedule 1:

  	
  Territory and Duration

  
	
  Schedule 2:

  	
  Product(s), Prices and Payment Terms

  
	
  Schedule 3:

  	
  Timings

  
	
  Schedule 4:

  	
  Adverse Drug Event (ADE) reporting Guidelines

  

 

 11
 

 

 

SIGNED as an Agreement by the parties

	
  Signed for and on behalf of 

  	
  )

  	
   

  	
   

  
	
  CSL Limited ACN
  051 588 348 

  	
  )

  	
  /s/ Colin Armit

  	
  12/11/01

  
	
  by its duly
  authorised 

  	
  )

  	
  Colin Armit 

  	
  (date)

  
	
  representatives

  	
  )

  	
  President Pharmaceuticals

  	
   

  
	
   

  	
  )

  	
   

  	
   

  
	
   

  	
  )

  	
  /s/ Peter Turvey

  	
  11/11/01

  
	
   

  	
  )

  	
  Peter Turvey

  	
  (date)

  
	
   

  	
  )

  	
  Company Secretary

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  )

  	
  /s/ Patrik Richard

  	
  02/11/2001

  
	
  Signed for and
  on behalf of 

  	
  )

  	
  Patrik Richard

  	
  (date)

  
	
  Berna Biotech
  Ltd

  	
   

  	
  Secretary General

  	
   

  
	
  by its duly
  authorised 

  	
   

  	
   

  	
   

  
	
  representatives

  	
   

  	
  /s/ Robert Mischler

  	
  02/11/2001

  
	
   

  	
   

  	
  Robert Mischler

  	
  (date)

  
	
   

  	
   

  	
  Head of Production

  	
   

  

 

 12
 

 

 

SCHEDULE 1

to the Supply Agreement between CSL and BERNA

Territory and Duration

	
  1:

  	
  Territory:

  	
  Worldwide non-exclusive subject to 1A and 1B below.

  
	
  1A:

  	
  Exclusive Territory:

  	
  Switzerland, Italy, Spain and Portugal.

  
	
  1B:

  	
  Excluded Territory:

  	
  Australia and New Zealand.

  
	
  2.

  	
  Duration:

  	
  The Initial Period commencing from the Commencement
  Date and ending on 31 December 2006.

  

 

 

 13
 

 

 

SCHEDULE 2

to the Supply Agreement between CSL and BERNA

	
  

  	
  Product(s),
  Prices and Payment Terms

  
	
  Product(s):

  	
  Bulk Inactivated Whole
  Virus Influenza Concentrate — Monovalent Pooled Harvest.

  
	
  Price:

  	
  The 2002 calendar year
  price for a trivalent dose (25mcgm of each strain) will be based on an amount
  of

  per egg used to
  manufacture the quantity of Product(s) delivered to BERNA. The
  relationship between price per egg used to manufacture the product and actual
  price paid per 25mcgm HA of each strain is dependant upon the egg yield.
  Using the average yield for the period l990-2000 the price of          per
  egg used relates to           per
  25mcgm trivalent dose. With better
  than average yields the price per dose reduces because the processing cost
  price is fixed, as shown in the table below.

  

 

	
  Yield

  	
   

  	
  Yield Per Egg

  (mcgm/egg)

  	
   

  	
  Price/Egg

  	
   

  	
  Price Per

  25mcgm Dose

  
	
  10% above
  average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10 Year Average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10% below
  average

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

Note: 

· the yield is indicative only, the actual
yield could be greater or lower than ± 10%.

CSL will notify BERNA of
indicative total cost of total order after one month of processing, ie
indicative yields will be communicated but accurate costs (total numbers of
eggs used) will not be finalised until completion of the total order. CSL will
notify BERNA with each delivery the total number of inoculated eggs used.

The quantity of
Product(s) delivered will be determined pursuant to the accepted SRID
assay method using the agreed SRID standard and the volume measured by CSL and
BERNA. Any difference of 10% or less between the CSL and BERNA test will result
in a sharing of the variance in terms of price on a 50:50 basis. If there is a
difference of more than 10% discrepancy between the CSL and BERNA test, CSL and
BERNA will discuss in good faith a resolution. If CSL and BERNA are unable to
resolve the discrepancy, then an independent testing agency tests the material.
The accepted result will be the average of the two closest results. The cost of
the independent testing agency will be shared equally by CSL and BERNA
regardless of the outcome.

	
  Payment Terms:

  	
   

  	
  If not otherwise specified, payment is due 60 days
  from date of invoice. Prices in Australian Dollars Ex Works, Parkville,
  Victoria 3052 (Incoterms 2000).

  
	
  Product Specification:

  	
   

  	
  General Specifications
  according to Specifications of European Pharmacopoeia already delivered to
  CSL.

  

 

Any change of the EuPharm
monography on influenza vaccines and Product testing requirements shall be sent
by BERNA to CSL or CSL to BERNA as soon as possible.

The Specifications for the
strains for the coming season shall be fixed according to the recommendations
of WHO and EU respectively and set out in BERNA’s order to CSL.

 

 14
 

 

 

SCHEDULE 3

to the Supply Agreement between CSL and BERNA

Timing of
Forecasts, Orders, etc

 

	
  Written best estimate from
  BERNA for following calendar year.

  	
   

  	
  30 June

  
	
   

  	
   

  	
   

  
	
  Update of
  written best estimate from BERNA for following calendar year.

  	
   

  	
  30 November

  
	
   

  	
   

  	
   

  
	
  Written
  notification from BERNA of packaging requirements.

  	
   

  	
  30 November

  
	
   

  	
   

  	
   

  
	
  GMP Agreement
  review and agreement regarding dossier preparation/updates.

  	
   

  	
  30 November

  
	
   

  	
   

  	
   

  
	
  Notification of
  Price Increase by CSL.

  	
   

  	
  31 January

  
	
   

  	
   

  	
   

  
	
  Firm order by
  BERNA.

  	
   

  	
  28 February

  
	
   

  	
   

  	
   

  
	
  Notification of
  Indicative Delivery Date by CSL.

  	
   

  	
  15 March

  
	
   

  	
   

  	
   

  
	
  Confirmation of
  Delivery Dates by CSL.

  	
   

  	
  30 April

  

 

 15
 

 

 

SCHEDULE 4

to the Supply Agreement between CSL and BERNA

Adverse Drug Event
(ADE) Reporting Guidelines

(Clause 20)

1.                          Principle:
The Adverse Drug Event (hereinafter ADE) reporting system shall correspond
basically to the European Union Directive (EU) 93/39 and the corresponding
regulations of each country of the Territories brought to knowledge of the
BERNA. The ADE shall preferably be forwarded using the format of the COMS-formulary.

2.                          CSL and
the BERNA shall keep one another informed on all reports of ADEs coming to
either party’s knowledge with regard to the Product(s), regardless of the
origin of such reports. The term “Reports” shall also include publications in
journals and other media.

3.                          Reports
on such ADEs which according to the informing party’s careful professional
evaluation may negatively affect the benefit-risk-ratio of the Product or may
have consequences regarding the Product’s Information (eg. labelling, data
sheets, package inserts) or may require immediate safety measures or regulatory
authorities (such as special information/warnings to the medical profession,
patients, authorities or withdrawal of the Product) shall be forwarded to the
other party without delay after having become known.

4.                          The same
immediate forwarding, without delay shall apply in cases of reports on ADEs
being both serious and unexpected (ie. hitherto not specified in the Product’s
Information).

5.                          The
informing party is invited to give both the primary reporter’s and its own
professional evaluation of such reports, in particular with regard to suspected
causality, with reasoning, either together with such information or at a later
date.

Categories for determining relationship of ADE to the Product:

·  Certain

·  Probable

·  Possible

·  Unlikely

·  Unrelated

·  Insufficient Evidence

6.                          The
aforementioned Information shall be addressed to

in case of CSL:   CSL LIMITED ACN
051 588 348

	
  Attention:

  	
  Head Medical Department

  
	
  45 Poplar Road, Parkville, Victoria, Australia 3052

  
	
  Telephone:

  	
  +61 3 9389 1911

  
	
  Facsimile:

  	
  +61 3 9389 1434

  
	
   

  	
   

  
	
  BERNA BIOTECH LTD

  
	
  Attention:

  	
  Head Medical Department

  
	
  Rehhagstrasse 79, CH-3018 Berne, Switzerland

  
	
  Telephone:

  	
  +41 31 980 67 37

  
	
  Facsimile:

  	
  +41 31 980 67 75

  

or to such other address as may thereafter be provided
by either party.

7.                          Reports
shall be established by BERNA and delivered according to clause 20 and
meetings, if necessary, shall be held at mutually convenient times and places,
for the purpose of discussing ADE issues.

8.                          All reports
to be provided hereunder shall be in English, using the MeDRA adverse reaction
terminology.

 

 16

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