exv4w26



 


Exhibit 4.26



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



DISTRIBUTION, MANUFACTURING, AND LICENSE AGREEMENT





	 	 	This Distribution, Manufacturing, and License Agreement is entered into at the
date of countersignature (the “Effective Date”) by and between Acambis Research
Limited, Peterhouse Technology Park, 100 Fulbourn Road, Cambridge CB1 9PT UK
(“Acambis Research”) and Baxter Healthcare SA, having offices at Hertistrasse
2, CH-8304 Wallisellen, Switzerland (“BHSA”) and Baxter Healthcare Corporation,
having offices at One Baxter Parkway, Deerfield, IL 60015 (“BHC”).
	 
	 	 	Table of Contents
	 
	1.	 	Recitals
	 
	2.	 	Definitions
	 
	3.	 	Distributorship





	 	3.1 	 	Grant of Distributor Rights in the Territory
	 
	 	3.2	 	 Distribution of Product Outside the Territory
	 
	 	3.3	 	 Marketing Authorisations





	4.	 	Description of Supplies and Services





	 	4.1 	 	Manufacture of Crude Bulk Vaccine
	 
	 	4.2	 	 Purification, Formulation, Fill/Lyophilize/Finish, and Diluent
	 
	 	4.3	 	 Labelling, Syringe, Kitting, Packaging ******
	 
	 	4.4 	 	Bifurcated Vaccinating Needles
	 
	 	4.5	 	 Distribution





	5.	 	Payment & Payment Amount
	 
	6.	 	Title and Risk of Loss
	 
	7.	 	Export/Import Requirements
	 
	8.	 	License & Non-Compete
	 
	9.	 	Audits & Reports
	 
	10.	 	Security
	 
	11.	 	Manufacturing Standards
	 
	12.	 	Limitations of Liability
	 
	13.	 	License Status
	 
	14.	 	Notification Procedures for Adverse Events and Pharmacovigilance
	 
	15.	 	Indemnity & Insurance
	 
	16.	 	Confidentiality
	 
	17.	 	Notices
	 
	18.	 	Term and Termination



ACAMBIS CONFIDENTIAL INFORMATION

 







 







	19.	 	Force Majeure
	 
	20.	 	Independent Organizations
	 
	21.	 	Intellectual Property
	 
	22.	 	Regulatory Support
	 
	23.	 	General
	 
	 	 	Attachment A — Vero Cell Know-How License between Baxter Healthcare SA
(Switzerland) and Acambis Inc.( December 02)
	 
	 	 	Attachment B – Product Pricing Recommendation Table for Sales to Customers
	 
	 	 	Attachment C – Sample Indemnification Template
	 
	1.0	 	 RECITALS
	 
	 	 	WHEREAS Acambis has developed a lyophilized smallpox vaccine manufactured in
vero cells (ACAM 2000 (Acambis)) that is the subject of BB-IND # 10628 filed
with the U.S. Food and Drug Administration on August 22, 2002;
	 
	 	 	WHEREAS Acambis Research intends to market and sell the ACAM 2000 (Acambis)
vaccine and the ACAM 2000 (******) vaccine and related components to
Governments other than the United States Government and to Non-Governmental
Organizations;
	 
	 	 	WHEREAS Baxter has developed an international sales force to market and make
sales to Government and Non-Government Organizations;
	 
	 	 	WHEREAS, Baxter and Acambis acknowledge that the Product (as hereinafter
defined) is not licensed in the Territory. Therefore, due to regulatory and
liability reasons, the Product shall not be distributed in the private market
under this Agreement;
	 
	 	 	WHEREAS Baxter has the capability and capacity to manufacture crude vaccine to
be processed into ACAM 2000 (Acambis) vaccine and/or ACAM 2000 (******)
vaccine; and
	 
	 	 	WHEREAS Baxter Healthcare SA (BHSA) and Acambis Inc., entered into the Vero
Cell Know-How License dated of December 2002 (Attachment A), that provides for
the transfer of Baxter’s Vero cell technology for ACAM 2000 to Acambis, Inc.
	 
	 	 	NOW, THEREFORE, THIS AGREEMENT WITNESSETH that in consideration of the mutual
agreements herein set forth and other valuable consideration, the Parties agree
as follows:



ACAMBIS CONFIDENTIAL INFORMATION

2







 







	2.0	 	 DEFINITIONS
	 
	 	 	In this Agreement, the following terms shall have the following meanings:
	 
	 	 	“ACAM 2000 (Acambis)” means the vaccine manufactured and tested as described in
BB-IND # 10628, as amended from time to time.
	 
	 	 	“ACAM 2000 (******)” means the vaccine consisting of the same Crude Bulk
Product as used for ACAM 2000 (Acambis), but purified at Baxter’s facility
****** and/or filled and finished (wet or lyophilized) under different
processes and locations than used to manufacture ACAM 2000 (Acambis).
	 
	 	 	“Agreement” means this Agreement, including all schedules, appendices, and
attachments and amendments agreed to in writing by the Parties;
	 
	 	 	“Acambis” means Acambis PLC and/or any of its affiliates or subsidiaries,
including but not limited to Acambis Research.
	 
	 	 	“Affiliate” means any company, partnership or other legal entity or person
which directly or indirectly controls, is controlled by or is under common
control with a Party.
	 
	 	 	“Baxter” means both BHSA and BHC unless otherwise indicated.
	 
	 	 	“Control” means the ownership of more than 50% of the issued share capital or
the legal power to direct or cause the direction of the Board or general
management and policies of the entity in question.
	 
	 	 	“Customer” means any governmental authority (military or civilian) other than
the United States Government, any third party acting on behalf of a
governmental authority other than the United States Government, or a
Non-Government Organization (NGO). Customer does not include a private
individual, doctor, hospital, or physician supply house. The U.S. Government
is not a Customer, whether purchasing the Product for its own use or for
transfer to a third-party.
	 
	 	 	“Crude Bulk Vaccine” means cell harvest of vaccinia virus grown on serum free
Vero cells that originates from the ACAM 1000 master virus seed and the ACAM
2000 production virus seed.
	 
	 	 	“Marketing Authorisations” means any and all authorisations required from any
Regulatory Authority to officially market, distribute, or sell the Product.
	 
	 	 	“Net Sales” means the actual total amount invoiced and/or received from a
Customer for the sale of any Product after deducting the following costs,
provided such costs are attributable to such sale of the Product and are
actually borne by the selling Party (whether Acambis Research or Baxter) and
are specifically itemized in a commission statement to the non-selling party
(Acambis Research or Baxter) and not otherwise incorporated into the sale to
the Customer: (i) outbound transportation expenses for shipments to Customers;
(ii) taxes consisting of sales, use, turnover, excise, export, import, duties
or VAT, separately billed or invoiced and borne by the selling Party imposed by
a government agency on such sales; (iii) credit or allowances given or made for
Product returned or not accepted by Customers, provided that such credit or
allowances shall not exceed the invoiced amount for such Product, (iv)
insurance charges covering the Product during transportation to the Customer;
(v) trade and/or cash discounts allowed and taken, for reasons such as quantity
purchased and (vi) liquidated damages of any kind stipulated in the sales
contract payable to a Customer in the Territory, including but not limited to
the damage caused by default or delay, provided that Acambis Research has
consented according to Article 3.1.4 and 3.1.5.



ACAMBIS CONFIDENTIAL INFORMATION

3







 







	 	 	“Non-Government Organization” means an organization which is independent from
the state and is self-governing, non-profit/not-for-profit and established
voluntarily by citizens or by legal entities other than State agencies (i.e.,
organizations that exercise legislative, executive, and/or judicial powers) on
the basis of their individual or social interests and opinions and are
associated with organizations such as the United Nations. Examples of
Non-Government Organizations are the World Health Organization and the Pan
American Health Organization.
	 
	 	 	“Party” means Acambis Research, BHSA or BHC.
	 
	 	 	“Parties” means Acambis Research, BHSA, and BHC together.
	 
	 	 	“Product” means either: (1) a 5,000 dose Smallpox Vaccine Kit containing (a)
fifty (50), 100-dose vials of lyophilized ACAM 2000 (Acambis)-vaccine
manufactured as described in the Product Specification below; (b) fifty (50)
vials of diluent with each vial being sufficient to reconstituted one vial of
lyophilized smallpox vaccine; (c) 5,000 bifurcated vaccinating needles; and (d)
50 syringes for transferring the diluent; (hereinafter “Smallpox Vaccine Kit”),
(2) a 5,000 dose Smallpox Vaccine Kit containing (a) fifty (50), 100-dose
vials of wet (liquid frozen) ACAM 2000 (******) vaccine manufactured as
described in the Product Specification below and (b) 5,000 bifurcated
vaccinating needles; (both (1) and (2) are hereinafter referred to as “Smallpox
Vaccine Kit”) or (3) Crude Bulk Vaccine as described in the Product
Specification below that has not been purified, formulated, lyophilized or
placed in vials (hereinafter “Crude Bulk Product”).
	 
	 	 	“Product Specification” means partially purified vaccinia virus produced in a
vero cell culture substrate with a final potency sufficient to confer immunity
against smallpox as specified in IND BB-10628 as amended from time-to-time or,
once US Food and Drug Administration licensure is granted, as specified in such
license.
	 
	 	 	“Regulatory Authority” means any authority having jurisdiction to regulate the
manufacture, sale, or distribution of the Product
	 
	 	 	“Scenario” means the split of responsibility for manufacturing the Product as
between Baxter and Acambis Research as defined in Provisions 4.0.1 and 5.3
	 
	 	 	“Seller” means the Party that sells the Product to a Customer. For sales of
Product for delivery to Customers within the Territory, the Seller shall be
BHSA or one of its affiliated companies or subsidiaries. For sales of Product
for delivery to Customers outside the Territory, the Seller shall be Acambis
Research or its designated agent(s)
	 
	 	 	“Term” shall have the definition given in Section 18.0.
	 
	 	 	“Territory”, as such term relates to sales to a government authority (military
or civilian) or any third-party acting on behalf of a government authority,
means all countries worldwide, excluding the United States (and its territorial
possessions) and the United Kingdom. “Territory”, as such term relates to
sales to Non-Government Organizations, shall mean all countries throughout the
world.
	 
	3.0 	 	DISTRIBUTORSHIP
	 
	3.1	 	 Grant of Distributor Rights in the Territory
	 
	3.1.1	 	 Subject to the terms and conditions of this Agreement, during the Term,
Acambis Research hereby appoints BHSA as Acambis’ Research’s exclusive
distributor in the Territory for the sole purposes of marketing,
promoting, soliciting customers for, distributing, and selling (or
otherwise disposing of) the Product to Customers for



ACAMBIS CONFIDENTIAL INFORMATION

4







 





	 	 	delivery in the Territory and BHSA accepts such appointment. BHSA may
not assign or otherwise transfer its distributorship rights, with the
exception as to affiliated companies or subsidiaries. Baxter shall not
actively sell or distribute the Product to any entity other than
Customers within the Territory. The Parties may however agree on a case
by case basis that Baxter uses a local distributor if required by local
law, regulations, or Government request.
	 
	3.1.2 	 	Acambis Research shall not, during the Term, appoint any other person,
firm, company or other entity as (a) its distributor for the marketing,
promotion,or sale of the Product to Customers in the Territory; (b) its
distributor for the solicitation of Customers for the Product to be
delivered in the Territory; or (c) agent or reseller of the Product to
Customers in the Territory.
	 
	3.1.3	 	 Acambis Research shall not, during the Term, market, promote or solicit
Customers for, or actively sell or distribute, the Product in the
Territory without the prior written consent of BHSA (such consent not be
unreasonably withheld or delayed). However, this provision does not
restrict Acambis Research from selling the Product in the Territory to
persons who are located within the European Union, who are not solicited
by Acambis Research and who approach Acambis Research on their own
initiative.
	 
	3.1.4	 	 BHSA shall coordinate each potential Customer order with Acambis
Research. Prior to signing any agreement or contract for the sale of a
Product, BHSA shall inform Acambis Research (in writing and in English) of
the material features of such agreement or contract, including but not
limited to: customer name, price for the Product, whether the Customer is
providing indemnity and the terms of such indemnity, payment terms, which
Product is being ordered (Smallpox Vaccine Kits containing ACAM 2000
(Acambis) vaccine, Smallpox Vaccine Kits containing ACAM 2000 (******)
vaccine, or Crude Bulk Product), proposed manufacturing and delivery
schedule, contractual consequences of delivery delays, potential Marketing
Authorization requirements that are indispensable to the Customer, any
regulatory requirements of the Customer or the competent Regulatory
Authority(ies) any special labelling requirements, under which Scenario
(as set for in Section 5.3 below) the Product will be manufactured, and,
if applicable, the Scenario under which the originally delivered liquid
ACAM2000 (******) Product will be replaced.
	 
	3.1.5	 	 Each Customer order must be approved by Acambis Research prior to Baxter
or its subsidiaries signing any agreement or contract for the sale of
Product, such approval shall not to be unreasonably withheld and shall be
compliant with applicable laws and regulations. Acambis Research agrees to
actively cooperate with Baxter and to use all commercially reasonable
endeavours to pursue with such approval.
	 
	3.1.6	 	 BHSA shall inform each Customer in the Territory that the Product: (a)
prior to licensure, is intended for emergency use only and is not a
licensed product in the Territory or the United Kingdom; and (b) until
such time that the Product receives licensure from the US Food and Drug
Administration (“US FDA”), is not licensed in the United States.
	 
	3.1.7	 	 Acambis Research has provided BHSA with a recommendation with regard to
Customer prices for the Product in the Territory, which is attached to
this Agreement as Attachment B (the price recommendations in Attachment B
reflect the prices for Customers
providing Attachment C indemnity). BHSA shall however not be obliged to
follow such recommendations.



ACAMBIS CONFIDENTIAL INFORMATION

5







 







	3.1.8	 	 BHSA shall not make or give any promises, warranties, guarantees or
representations concerning the Product other than those contained in
BB-IND # 10628 and/or in Acambis Research’s product literature and shall
provide the Customer with a detailed outline description of the qualities
and specifications of ACAM 2000 (******) vaccine and ACAM 2000 (Acambis)
vaccine. Baxter and Acambis Research shall jointly create a document that
shall be provided to each Customer which outlines the differences of ACAM
2000 (Acambis) compared to ACAM 2000 (******). Baxter shall market the
ACAM 2000 (Acambis) vaccine only for the indications authorised by the US
FDA and, if applicable, may market the ACAM 2000 (******) vaccine only for
those indications as authorized by the competent Regulatory Authority(ies)
in the Customer’s territory. Baxter shall market the ACAM 2000 (Acambis)
vaccine as Acambis vaccine and not represent or otherwise give the
appearance to a Customer that the ACAM 2000 (Acambis) vaccine is a Baxter
vaccine.
	 
	3.1.9	 	 If Acambis Research believes that BHSA is not using all reasonable
endeavours to market and promote the Product in a country of the Territory
or is not otherwise complying with its obligations under this Agreement in
a country in the Territory (the “Neglected Country”), Acambis Research may
provide written notice thereof to BHSA, specifying the basis of its belief
and any additional commercial activities Baxter should reasonably
undertake. Within 30 days of such notification, the Parties shall meet
and discuss in good faith the steps Baxter is taking to market and promote
the Product and any such additional activities BHSA should commercially
reasonably undertake. In the event that the parties are unable to agree
on such additional activities or if BHSA does not undertake agreed upon
remedial steps to remedy any default within 60 days of notice, Acambis
Research may terminate the assignment of BHSA being the exclusive
distributor as set forth in Art 3.1.1 of this Agreement in the Neglected
Country and such Country shall be excluded from the Territory.
	 
	3.1.10 	 	Provided that Acambis Research has consented according to Article 3.1.4
and 3.1.5, BHSA may offer to Customers who have been provided with liquid
frozen Product the subsequent delivery of lyophilised Product at no
charge. After the free delivery of the lyophilised Product, BHSA shall be
responsible for it’s disposal. BHSA may not resell such liquid frozen
Product.
	 
	3.1.11	 	 BHSA shall not promote, make sales or otherwise engage in negotiations
related to the Product to any country, identified as acting contrary to
the foreign policy and national security goals of the U.S., restricted
under internal policy or in contravention of any international conventions
established by the United Nations, including but not limited to the list
of countries that the US Secretary of State has made a determination (that
remains in effect) that such country has repeatedly provided support for
acts of international terrorism. At the time of signing this Agreement,
that list is: Iran, Iraq, Libya, Syria, Cuba, North Korea, and Sudan.
	 
	3.1.12	 	 Should during the term of this Agreement or thereafter Acambis decide
to market the Product to private individuals or entities outside the
United States or its territories, or the United Kingdom, then the Parties
shall enter into good faith discussions as to whether it might be
agreeable to use Baxter as a potential distributor.
	 
	3.2	 	 Distribution of Product Outside the Territory
	 
	3.2.1	 	 BHSA shall not, during the Term, market, promote or solicit persons for,
or actively sell or distribute, the Product outside the Territory
without the prior written consent of



ACAMBIS CONFIDENTIAL INFORMATION

6







 



	 	 	Acambis Research (such consent not be
unreasonably withheld or delayed). However, this provision does not
restrict BHSA from selling the Product outside the Territory to Customers
who are located within the European Union, who are not solicited by Baxter
and who approach Baxter on their own initiative. Such sales will be
subject to the same payment obligations as sales within the Territory as
set out in Section 5 below. Baxter may cooperate with or provide sales
assistance to Acambis to promote the Product to Customers outside the
Territory, however, absent written agreement to the contrary, Baxter shall
not receive payment for such cooperation or sales assistance in addition
to the split of Net Sales addressed in provision 5.3 below.
	 
	3.3	 	 Marketing Authorisations
	 
	3.3.1	 	 ACAM 2000 (Acambis)
	 
	3.3.1.1	 	 Acambis shall initially have the right to file for any Marketing
Authorization(s) with respect to ACAM 2000 (Acambis). Should Acambis
decide, in its sole discretion, to apply for and obtain a Marketing
Authorization in a country or region, then Acambis will be responsible for
filing and maintaining the Marketing Authorization(s) for ACAM 2000
(Acambis) and shall bear all related costs. If (1) Acambis decides to not
apply for or obtain a Marketing Authorization in a specific country or
region or (2) Baxter or any Baxter affiliate is required by law or
government request to apply for a Marketing Authorization in any country,
then Acambis and BHSA shall consult to jointly decide if a Marketing
Authorization in this particular country is commercially justified from a
business perspective. Acambis shall not unreasonably refuse to file and
maintain the Marketing Authorization(s) for ACAM 2000 (Acambis) nor shall
it unreasonably refuse to allow Baxter or any Baxter affiliate to file for
a Marketing Authorization under the circumstances of (2) above.
	 
	3.3.1.2	 	 If obtaining a Marketing Authorization for a certain country or region
is not commercially justified from a business perspective and Acambis
elects not to file for such Authorization, Baxter may apply for and obtain
such Marketing Authorization(s) and shall bear all related costs.
	 
	3.3.1.3	 	 Baxter shall provide all documents to Acambis (either in English or
German) required for Acambis to apply for and obtain such Marketing
Authorization(s). Baxter shall not be required to provide any document or
information that is not in its possession or that Baxter is not entitled
to disclose to Acambis.
	 
	3.3.2	 	 ACAM 2000 (******)
	 
	3.3.2.1	 	 If (1) Baxter or any Baxter affiliate is required by law or government
request to apply for and obtain a Marketing Authorization for ACAM 2000
(******) or (2) Baxter determines that it wants to apply for and obtain a
Marketing Authorization for ACAM 2000 (******), Baxter may do so. Should
Baxter decide to apply for and obtain a Marketing Authorization for ACAM
2000 (******), Baxter shall bear all related costs.
	 
	3.3.2.2	 	 If, in the first instance discussed in Provision 3.3.2.1 above, Baxter
decides not to apply for and obtain a Marketing Authorization, then
Acambis and BHSA shall consult to jointly
decide if a Marketing Authorization in this particular country is
commercially justified from a business perspective.
	 
	3.3.2.3	 	 Acambis shall provide all documents to Baxter (in English) required for
Baxter to apply for and obtain such Marketing Authorization(s). Acambis
shall not be required to



ACAMBIS CONFIDENTIAL INFORMATION

7







 





	 	 	provide any document or information that is not
in its possession or that Acambis is not entitled to disclose to Baxter.
	 
	3.3.3	 	 At the conclusion or termination of this Agreement, BHSA shall transfer
all ACAM 2000 (Acambis) Marketing Authorizations acquired under this
Article and all materials obtained from Acambis Research hereunder to
Acambis Research. Such transfer shall be at no charge to Acambis Research
other than Acambis Research shall reasonably compensate BHSA for it’s
transfer activities relating to transferring the Marketing
Authorization(s) from BHSA’s name to Acambis’ name.
	 
	4.0	 	 DESCRIPTION OF SUPPLIES AND SERVICES
	 
	4.0.1	 	 The division of manufacturing responsibilities described in Provisions
4.1 through 4.5 below shall be divided between Baxter and Acambis Research
as indicated in the Scenarios set forth in provision 5.3 below. Baxter
and Acambis Research shall agree on which Scenario will be utilized for
each sale of the Product prior to either Party executing any agreement
with a Customer. If the division of manufacturing responsibilities
proposed by the Seller is not included in the provision 5.3 Scenarios,
Baxter and Acambis Research shall negotiate in good faith to reach a
reasonable split of the Net Sales based on their relative contributions to
manufacturing the Product.
	 
	4.0.2	 	 The cost for performing the manufacturing responsibilities as detailed
in the various Scenarios shall be borne by the Party having the
responsibility for performing such responsibilities.
	 
	4.0.3	 	 Baxter and Acambis agree that they will use the highest diligence
reasonable in performing their respective responsibilities under this
Agreement.
	 
	4.0.4	 	 BHSA agrees to inform Acambis within fifteen (15) calendar days of the
result of any regulatory development or material change to the Vero Cell
Master File. BHSA shall be responsible for all costs related to the
creation and maintenance of the Vero Cell Master File.
	 
	4.0.5	 	 Acambis, as the IND (and later product license) holder for the ACAM 2000
(Acambis) vaccine in the United States, shall be responsible for reporting
any biological Product deviations to the US FDA under 21 CFR 600.14 and
shall bear all costs related to licensure of ACAM 2000 (Acambis) vaccine
in the United States. Baxter agrees to inform Acambis of any deviations
that might be reportable under 21 CFR 600.14 within ten (10) calendar days
of obtaining such information.
	 
	4.0.6	 	 The Party who is the Marketing Authorization holder for ACAM 2000
(Acambis) vaccine or ACAM 2000 (******) vaccine for the Marketing
Authorization in a country other than the United States shall be
responsible for all reports required by the relevant Regulatory
Authority(ies) arising out of product deviations. The non-Marketing
Authorization holding Party agrees to inform the Marketing Authorization
holding party of any reportable deviations within ten (10) calendar days
of obtaining such information.
	 
	4.0.7	 	 For ACAM 2000 (******) vaccine distributed by Baxter under this
Agreement, Acambis shall provide all reasonably necessary materials,
documents and assistance (not including 3d party proprietary information)
to support the technical transfer of purification and formulation
activities from Acambis to Baxter. Baxter shall perform any and all
pre-clinical studies and clinical trials (bridging or otherwise) required
to meet any and all regulatory requirements in the Territory should the
Parties decide to market such 



ACAMBIS CONFIDENTIAL INFORMATION

8







 





	 	 	ACAM 2000 (******) vaccine in a particular
country in the Territory. However, nothing in this Provision 4.0.7 shall
negatively impact orders for ACAM2000 (Acambis) smallpox vaccine from the
United States Government.
	 
	4.0.8	 	 For ACAM 2000 (Acambis) vaccine, the Marketing Authorization holder is
responsible for all pre-clinical studies and clinical trials required by
the relevant Regulatory Authority. For those countries where Baxter is
authorized by Acambis to be the Marketing Authorization holder, Baxter
shall provide information related to such non-US product Marketing
Authorization, pre-clinical studies, and/or clinical trials to Acambis as
required by the US FDA.
	 
	4.0.9	 	 Each Party agrees to provide and maintain quality systems according to
cGMP and to provide the other Party access to its facilities at all
reasonable times for surveillance.
	 
	4.1	 	 Manufacture of Crude Bulk Vaccine
	 
	4.1.1	 	 ******
	 
	4.1.2	 	 ******
	 
	4.1.3	 	 ******
	 
	4.1.4	 	 ******
	 
	4.1.5	 	 ******
	 
	4.1.5.1	 	 ******




ACAMBIS CONFIDENTIAL INFORMATION

9







 







	 	 	*****
	 
	4.1.6	 	*****
	 
	4.1.6.1	 	*****
	 
	4.1.6.2	 	*****
	 
	4.1.6.3	 	*****
	 
	4.1.6.4	 	*****
	 
	4.1.6.5	 	*****
	 
	4.1.7	 	*****
	 
	4.1.7.1	 	*****




ACAMBIS CONFIDENTIAL INFORMATION

10







 







	 	 	*****
	 
	4.2.0	 	 Purification, Formulation, Fill/Lyophilize/Finish, and Diluent
	 
	4.2.0.1	 	*****
*****
	 
		 	 ******
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	 	 	*****
	 
	4.2.4.1	 	*****
	 




ACAMBIS CONFIDENTIAL INFORMATION

11









 




	 	 	 
	4.3	 	
Labelling, Syringe, Kitting, Packaging ******




******



     ******




******



     ******




******



     ******




	 	 	 	 	 
	 	 	
(a)
	 	******
	 	 	 	 	 
	 	 	
(b)
	 	******
	 	 	 	 	 
	 	 	
(c)
	 	******
	 	 	 	 	 
	 	 	
(d)
	 	******
	 	 	 	 	 
	 	 	
(e)
	 	******




	 	 	 
	4.3.4	 	
******




******




ACAMBIS CONFIDENTIAL INFORMATION



12







 





******




******




******




******




******




******




******




******




******




******




******




******




******




******




******




ACAMBIS CONFIDENTIAL INFORMATION



13







 





******




******




******




	 	 	 
	4.4	 	
Bifurcated Vaccinating Needles
	 	 	 
	4.4.1	 	
******
	 	 	 
	4.4.2	 	
******
	 	 	 
	4.4.3	 	
******
	 	 	 
	4.5	 	
Distribution
	 	 	 
	4.5.1.	 	
******
	 	 	 
	5.0	 	
PAYMENT AND PAYMENT AMOUNT
	 	 	 
	5.1	 	
Payment from the Customer shall be made under the terms in the agreement
between the Customer and the Seller.
	 	 	 
	5.2	 	
Within 30 days of Seller’s receipt of Customer payment, the Seller shall
forward to the other Party its share of the Net Sales.
	 	 	 
	5.3	 	
The payment amount due shall be determined by splitting the Net Sales
amount between Baxter and Acambis Research according to which Scenario (1
through 5) was utilized to manufacture the Product. The Scenarios and the
split of the Net Sales are as follows:




ACAMBIS CONFIDENTIAL INFORMATION



14







 





	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Labelling,	 	 	 	 	 	 	 	Net Sales Split
	 	 	 	 	 	 	Kitting,	 	 	 	Distribution	 	 	 	in case of later
	 	 	Manufacture	 	Purify/Formulate	 	Syringe,	 	 	 	as set	 	 	 	replacement of
	 	 	Crude	 	Fill/Finish &	 	Packaging &	 	 	 	forth in	 	Net Sales	 	the liquid
	Scenario	 	Bulk	 	Diluent	 	Storage	 	Needles	 	Provision 3.0	 	Split	 	ACAM 2000(***)
	
	 	
	 	
	 	
	 	
	 	
	 	
	 	

	1 –	 	
Baxter
	 	AR1
	 	Baxter
	 	AR
	 	Baxter or
	 	******
	 	******
	 	 	 	 	 	 	 	 	 	 	AR	 	 	 	 
	2 –	 	
Baxter
	 	AR
	 	Acambis
	 	AR
	 	Baxter or
	 	******
	 	******
	 	 	 	 	 	 	 	 	 	 	AR	 	 	 	 
	3 –	 	
Baxter
	 	Baxter
	 	Baxter
	 	AR
	 	Baxter or
	 	******
	 	******
	 	 	 	 	 	 	 	 	 	 	AR	 	 	 	 
	4 –	 	
Baxter
	 	—
	 	Baxter
	 	—
	 	Baxter or
	 	******
	 	******
	 	 	 	 	 	 	******
	 	 	 	AR	 	 	 	 
	5–	 	
AR
	 	AR
	 	AR
	 	AR
	 	Baxter
	 	******
	 	******




	 	 	 	 	 	 	 
	 	 	 	
5.4	 	 	The exchange rate applicable to payments for the split of Net Sales under
this Agreement shall be the exchange rate published in the London
Financial Times in effect on the date the Seller receives payment for the
Product from a Customer. Payments to Acambis Research shall be made in
Euros.
	 	 	 	 	 	 	 
	 	 	 	
5.5	 	 	Payment of the split of Net Sales shall be accompanied by an accounting
detailing: the date payment from the Customer was received, the method
used for determining the amount of payment due from the Customer to the
Seller, the gross sales price of the Product, the method of calculating
the Net Sales, the Scenario utilized to supply the Product to the
Customer, the applicable split of Net Sales, and the exchange rate (and
date of such rate).
	 	 	 	 	 	 	 
	 	 	 	
5.6	 	 	Payment to BHSA shall be submitted to:
	 	 	 	 	 	 	Baxter Healthcare SA
	 	 	 	 	 	 	Hertistr. 2
	 	 	 	 	 	 	CH-8304 Wallisellen, Switzerland
	 	 	 	 	 	 	Contact person: ******







1 AR = Acambis Research



2 This ****** Net Sales Split for Baxter includes the ****** that would have
otherwise been calculated and paid under the Vero Cell Know-How License.



3 This ****** Net Sales Split for Baxter includes the ****** that would have
otherwise been calculated and paid under the Vero Cell Know-How License.




ACAMBIS CONFIDENTIAL INFORMATION



15







 




	 	 	 
	 	 	
bank details:
	 	 	
******
	 	 	 
	 	 	
******
	 	 	 
	 	 	
******
	 	 	 
	5.8	 	
Payment to Acambis Research shall be submitted to:
	 	 	
Acambis Research Limited (Attn:Chief Business Officer)

Peterhouse Technology Park,

100 Fulbourn Road, Cambridge CB1 9PT UK
	 	 	 
	6.0	 	
TITLE AND RISK OF LOSS
	 	 	 
	6.1	 	
Legal title to the vaccine product involved in the performance under this
Agreement shall pass for each Scenario outlined in Art. 5 according to
this Article.
	 	 	 
	6.1.1	 	
SCENARIOS 1 and 2: Legal title to the Crude Bulk Vaccine shall pass from
Baxter to Acambis Research upon shipment from Baxter ******
(EXW Incoterms 2000). Title to the Product shall vest in BHSA upon delivery of the
Product to a Customer.
	 	 	 
	6.1.2	 	
SCENARIOS 3 and 4: Legal title to the vaccine shall be borne by BHSA
until Customer’s receipt of Product. Should BHSA not be the Seller in this
Scenario 3, then legal title shall vest in Acambis Research upon delivery
of the Product to a Customer.
	 	 	 
	6.1.3	 	
SCENARIO 5: Legal title to the vaccine shall be borne by Acambis
Research. Legal title shall vest in BHSA upon delivery of the Product to a
Customer.
	 	 	 
	6.2	 	
Legal title to the Product components (e.g., diluent, vaccinating
needles, and syringes) shall be held by the Party who provided such
components. Unencumbered legal title to such components shall vest in the
Seller immediately upon shipment of Product to a Customer.
	 	 	 
	6.3	 	
Risk of loss for the vaccine and other Product components shall fall on
the Party in possession (personally or through its agent(s)) of such
vaccine and/or Product component at the time of the loss or, when the
vaccine or components are in transit, on the Party responsible for
arranging the transit.
	 	 	 
	7.0	 	
EXPORT/IMPORT REQUIREMENTS
	 	 	 
	7.1	 	
If Product will be exported from the United States, the Party responsible
for distribution of the Product shall obtain, at its own risk and expense,
any export license or other official authorisation and carry out, where
applicable, all customs formalities for the export of Product from the US
under this Agreement and the import of such Product. The Party not
responsible for exporting the Product shall use all reasonable endeavours




ACAMBIS CONFIDENTIAL INFORMATION



16







 





	 	 	 
	 	 	
to assist the exporting Party in obtaining such import license or other
authorisations necessary for the export of Product.
	 	 	 
	7.2	 	
If the Product will be exported from a country other than the United
States, Baxter shall be required to obtain, at it’s own risk and expense,
any export license or other official authorisation and carry out, where
applicable, all customs formalities for the export of Product and the
import of such Product. Acambis shall use all reasonable endeavours to
assist BHSA in obtaining such import license or other authorisations
necessary for the export of Product.
	 	 	 
	7.3	 	
Baxter, at its own risk and expense, shall obtain any and all permits,
licenses or other official authorisations and carry out, where applicable,
all customs formalities for the export and/or import of purified and
formulated ACAM 2000 (******).
	 	 	 
	7.4	 	
The Party responsible for obtaining the export license or other official
authorisation as set forth in provisions 7.2 through 7.4 shall also be
responsible for insuring compliance with export requirements, including
but not limited to those requirements of the Bureau of Export
Administration (BXA) and the Bureau of Industry and Security (BIS) of the
US Department of Commerce.
	 	 	 
	8.0	 	
LICENSE & NON-COMPETE
	 	 	 
	8.1	 	
License
	 	 	 
	8.1.1	 	
Acambis hereby grants BHSA a royalty-free non-exclusive license to
manufacture Crude Bulk Vaccine from fermenter runs ******, however, such
Crude Bulk Vaccine cannot be purified, formulated, marketed, or sold
unless authorized by Acambis (in
writing) in its sole discretion. Should Acambis not authorize BHSA to
purify, formulate, market or sell the Crude Bulk Vaccine from fermenter
runs ******, Baxter shall destroy such Crude Bulk vaccine at the end of
the term, or upon termination of, this Agreement.
	 	 	 
	8.1.2	 	
Acambis hereby grants BHSA a royalty-free non-exclusive license to
purify, formulate, fill, lyophilize or manufacture liquid frozen Product,
finish and market up to ****** doses of Crude Bulk Vaccine for sales to
Customers. BHSA shall complete purification and formulation of the ******
Crude Bulk Vaccine by ******. BHSA shall fill and finish the purified
vaccine (wet or lyophilized, as appropriate), and supply diluent (if
required) and syringes to accompany such product. Baxter shall perform
this activity with no additional requirements on Acambis personnel or
Baxter personnel co-located at Acambis with the exception that Acambis
will furnish limited assistance in accordance with BHSA’s requirements,
including: providing bifurcated vaccinating needles, performing selected
quality control tests, and providing limited regulatory support.
	 	 	 
	8.1.3	 	
If the manufacture of additional Crude Bulk Vaccine is desired by
Baxter, Baxter shall request, in writing to Acambis Research, that Acambis
grant to BHSA and its affiliate, ******, a royalty-free non-exclusive
license to manufacture additional Crude Bulk Vaccine solely for the
purposes of selling Product to a Customer under this Agreement for
delivery within the Territory. Such Request shall include the reason for
the request and the anticipated timeline.
	 	 	 
	8.1.4	 	
If the manufacture and marketing of additional finished vaccine beyond
the license granted in 8.1.2 is desired by Baxter, Baxter shall request,
in writing to Acambis




ACAMBIS CONFIDENTIAL INFORMATION



17







 





	 	 	 
	 	 	
Research, that Acambis grant to BHSA a royalty-free
non-exclusive license to purify, formulate,fill/lyophilize,manufacture and
market liquid frozen Product/finish ACAM 2000 (******) vaccine solely for
the purpose of selling Product to a Customer under this Agreement for
delivery within the Territory. Such request shall include: proposed
timelines, a plan to provide fill/lyophilization, marketing or the
manufacture of liquid frozen Product/finish services (if proposed), and a
plan to provide diluent (if proposed).
	 	 	 
	8.1.5	 	
Baxter agrees that it shall not use the ACAM 2000 strain, or authorise
others to use the strain, for any purpose other than the marketing and
sale of Product to Customers within the Territory as set forth in this
Agreement.
	 	 	 
	8.1.6	 	
For the duration of this Agreement, Acambis grants to BHSA a
non-exclusive royalty- free license to use Acambis’ intellectual property
rights (including any and all trademarks, logos and other markings used by
Acambis) that are reasonably necessary to promote the sale of the Product
to Customers within the Territory. Baxter shall not represent ACAM 2000
(******) vaccine to be ACAM 2000 (Acambis) vaccine. Intellectual property
rights licensed from Acambis to BHSA used or embodied in the Product
remain as the sole property of Acambis. BHSA shall not apply for
registration of or register any intellectual property rights that claim
the ACAM2000 (Acambis) or the Acambis processes for which Acambis has
licensed BHSA without the prior written consent of Acambis.
	 	 	 
	8.1.7	 	
BHSA agrees that it will (a) use the trademarks of Acambis only in a
manner from time to time approved by Acambis accompanied by an
acknowledgment that the same are the trademarks of Acambis, (b) not use
the trademarks of Acambis in relation to any other products or in any way
which might prejudice their distinctiveness or validity or the
goodwill of Acambis therein; (c) not use any other trademarks so
resembling the trademarks of Acambis as to be likely to cause confusion
or deception; and (d) not use the trademarks of Acambis in combination
with any other trademark or other names or logos other than trademarks of
Baxter, except with the prior written consent of Acambis. BHSA agrees
that the use of the trademarks of Acambis and all goodwill associated
therewith, shall inure to the benefit of Acambis.
	 	 	 
	8.1.8	 	
Baxter’s right to use Acambis’ technology and the ACAM 2000 vaccine
strain is limited to the extent expressly stated in this Agreement and
Acambis retains all right, title and interest to the Acambis technology,
the ACAM 2000 vaccine strain, and all related intellectual property rights
and proprietary rights held by Acambis.
	 	 	 
	8.1.9	 	
The grant of the licenses from Acambis to Baxter under this Agreement
shall be free of any charges whatsoever.
	 	 	 
	8.2	 	
Non-Compete
	 	 	 
	 	 	
Neither Baxter nor any affiliate shall sell or market smallpox vaccine
other than the Product inside or outside of the Teritorry during the term
of this Agreement.
	 	 	 
	9.0	 	
AUDITS AND REPORTS
	 	 	 
	9.1	 	
Acambis Research shall have the right to audit Baxter’s facilities to
determine compliance with (i) cGMP and (ii) applicable federal, state, and
local laws, regulations and rules regarding facilities. Baxter shall have
the right to conduct similar audits of




ACAMBIS CONFIDENTIAL INFORMATION



18







 





	 	 	 
	 	 	
Acambis’ facilities as required by
the Marketing Authorization held by Baxter (if any), by law or regulations
or upon request of a Customer. Such audits shall be scheduled at mutually
agreeable times upon two (2) business days written notice and shall not
occur more than one (1) time per calendar year unless required by BHSA’s
or BHC’s compliance status or Acambis’ obligations as a license holder.
In connection with performing such audits, each party shall bear its own
expenses. All information disclosed or reviewed in such inspections shall
be deemed and treated as Confidential Information as stipulated in this
Agreement.
	 	 	 
	9.2	 	
Baxter shall inform Acambis Research about the progress of its sales and
marketing activities of the Product in the Territory at least on a monthly
basis. Acambis shall provide Baxter with manufacturing updates, including
but not limited to information on any event or difficulty that may have a
potential impact on the delivery schedules agreed upon or negotiated
between Sellers and Customers.
	 	 	 
	9.3	 	
Additionally, Baxter shall submit quarterly reports to Acambis Research
detailing:




	 	 	 	 	 
	 	 	
(a)
	 	Potential and actual sales in and outside the Territory;
	 	 	 	 	 
	 	 	
(b)
	 	Current and planned marketing efforts in and outside the
Territory;
	 	 	 	 	 
	 	 	
(c)
	 	a list of current contracts for the sale of Product to
Customers and the price for the Product in such contracts;
	 	 	 	 	 
	 	 	
(d)
	 	Status of manufacturing activities for Product;
	 	 	 	 	 
	 	 	
(e)
	 	Anticipated payment dates for outstanding Product to be
delivered to a Customer; if known, and
	 	 	 	 	 
	 	 	
(f)
	 	Schedule of planned manufacturing activities.




	 	 	 
	9.4	 	
Baxter and Acambis Research shall keep proper records and books of
account and all proper entries therein relating to the Product sold to
Customers for delivery in the Territory (Baxter) and for delivery outside
the Territory (Acambis Research) and the amounts paid by Customers and
shall maintain such records for seven years after the expiration of the
Term or termination of this Agreement. Baxter and Acambis, and their
respective auditors, shall have the right to inspect such books and
records (upon reasonable, prior written notice, during regular business
hours), for the sole purpose of verifying the reports, information and
payments provided or due hereunder and verifying compliance with the
material terms and conditions of this Agreement. If such audit should
disclose any underpayment of the split of Net Sales, the underpaying party
shall be given a reasonable time to assess the situation and provide the
other party with a counter statement, and, if the underpayment is
substantiated, promptly pay the amount due, together with interest thereon
at a rate of one and one-half percent (1.5%) per month from the date such
amount was due until fully paid. If the parties fail to reach an agreement
upon such underpayment, an independent third party shall be mutually
identified by Acambis Research and Baxter in order to decide upon the
alleged underpayment. If the amount of such underpayment exceeds 10% of
the total amount due from that sale, the underpaying party shall
immediately reimburse the expenses associated with such audit.




ACAMBIS CONFIDENTIAL INFORMATION



19







 





	 	 	 
	10.0	 	
SECURITY
	 	 	 
	 	 	
BHSA and BHC agree that the work and services performed under this
Agreement shall be carried out under appropriate security designed to
protect the Product from theft, damage, and tampering.
	 	 	 
	11.0	 	
MANUFACTURING STANDARDS
	 	 	 
	11.1	 	
For the manufacture of Product that includes ACAM 2000 (Acambis) vaccine
or Crude Bulk Vaccine, all supplies and services (including all
manufacturing activities) performed under this Agreement shall comply with
all applicable US FDA requirements and cGMP regulations of the United
States of America. If at any time during the life of this Agreement,
BHSA or BHC fail to comply with cGMP in the manufacturing or packaging of
the Product that includes ACAM 2000 (Acambis) vaccine or Crude Bulk
Vaccine and such failure results in a material adverse effect on the on
the safety, purity, or potency of the Product (a material failure) as
identified by the Center for Biologics Evaluation and Research of the US
FDA, BHSA and/or BHC shall have thirty (30) calendar days from the time
such material failure is identified within which to cure such material
failure. If BHSA and/or BHC fail to take such an action within the thirty
(30) calendar day period, then this Agreement may be terminated by
Acambis, at Acambis’ sole discretion.
	 	 	 
	11.2	 	
The manufacture of Product that includes ACAM 2000 (******) vaccine shall
comply with the rules and regulations of the relevant Regulatory
Authority(ies) and shall be in substantial compliance with the cGMP
regulations of the United States and all applicable US FDA requirements.
	 	 	 
	11.3	 	
Baxter and Acambis shall manufacture any Product to be sold under this
Agreement that includes ACAM 2000 (Acambis) vaccine or ACAM 2000 (******)
vaccine to the applicable cGMP and the other regulatory standards
appropriate for the status of the Product as marketed and sold
	 	 	 
	12.0	 	
LIMITATIONS OF LIABILITY
	 	 	 
	12.1	 	
Except as explicitly set out in this Agreement, all conditions,
warranties, and representations, expressed or implied by (i) statute or
(ii) otherwise, in relation to the Product are excluded to the extent
possible under the applicable laws.
	 	 	 
	12.2	 	
To the extent possible under the applicable laws, and except with respect
to damages (other than lost profits) arising out of or relating to
breaches of this Agreement, Baxter is not liable to Acambis, and Acambis
is not liable to Baxter, whether for negligence, tort, breach of contract,
misrepresentation or otherwise, for:




	 	 	 	 	 
	 	 	
(a)
	 	loss or damage incurred as a result of third
party claims;
	 	 	 	 	 
	 	 	
(b)
	 	loss of profit, goodwill, business opportunity
or anticipated saving;
	 	 	 	 	 
	 	 	
(c)
	 	indirect or consequential loss or damage;
	 	 	 	 	 
	 	 	
(d)
	 	property damage; or
	 	 	 	 	 
	 	 	
(e)
	 	death or personal injury.




ACAMBIS CONFIDENTIAL INFORMATION



20







 





13.0 LICENSE STATUS



13.1 No Marketing Authorization has been issued for the Product inside the
Territory or outside the Territory. Acambis shall inform BHSA on a continuous
basis about the status of Marketing Authorizations for the Product in the US,
Canada, and Europe (through the EMEA). Should Acambis grant Baxter the right
to hold a Marketing Authorization for either ACAM 2000 (Acambis) or ACAM 2000
(******) under provision 3.3 above, Baxter shall inform Acambis Research on a
continuous basis about the status of the Marketing Authorizations of the
Product in those countries where Baxter holds or is seeking a Marketing
Authorization.




	 	 	 
	14.0	 	
NOTIFICATION PROCEDURES FOR PHARMACOVIGILANCE & RECALL
	 	 	 
	14.1	 	
Adverse Events / Adverse Experiences
	 	 	 
	14.1.1	 	
The Parties shall promptly inform each other of all reports of adverse
experiences / adverse events (AE’s) in respect of the Product coming to
the knowledge of either party. Serious AE’s shall be communicated promptly
by telefax to the other Party. Any AE that involves a death shall be
reported within 24 hours and any serious AE shall be reported within 48
hours according to a standard operating procedure to be agreed upon
between Acambis Research and Baxter within three months of the execution
date of this Agreement. Prior to licensure, each Party shall cooperate
with the other to allow the holder of the pre-licensure application to
report and manage any AE’s as required by the applicable Regulatory
Authority(ies). For Products sold to Customers in the Territory, after
applying for and receiving a Marketing Authorization, the Marketing
Authorization holding party shall be solely responsible for investigating
and evaluating each AE in order to meet legal, regulatory, and contractual
requirements for risk assessment or proper reporting to the authorities.
The non Marketing Authorization holding party shall reasonably support the
holder of the Marketing Authorization in such activities. Baxter and
Acambis Research shall jointly agree on a fair schedule on compensation
for the regulatory support of the non Marketing Authorization holding
party under this Article.
	 	 	 
	14.2	 	
Recalls
	 	 	 
	14.2.1	 	
Product recalls involving any ACAM 2000 Product for which Acambis has
applied for or obtained an Investigational New Drug (IND) application or a
Biological License Application (BLA) under United States law or a
non-United States Marketing Authorization, that is sold to a Customer in
the Territory shall be carried out in accordance with a standard operating
procedure to be agreed upon between Acambis Research and Baxter within
three months of the execution date of this Agreement.
	 	 	 
	14.1.2	 	
For the recalls addressed in Provision 14.2.1, Baxter shall provide
reasonable assistance to Acambis Research in any recall of such Product
distributed by Baxter in the Territory. Baxter and Acambis shall jointly
develop and execute any such recall in accordance with a recall procedure
which is compliant with the requirements of the relevant Regulatory
Authority(ies) having jurisdiction. Baxter and Acambis Research shall
jointly agree on a fair schedule on compensation for Baxter’s regulatory
support under this Article.
	 	 	 
	14.1.3	 	
For Product that includes ACAM 2000 (******) where Acambis does has not
applied for or received a Marketing Authorization, Baxter shall, at its
own expense, develop procedures and perform any recall of the Product
consistent with Baxter policies and




ACAMBIS CONFIDENTIAL INFORMATION



21







 





	 	 	 
	 	 	
procedures and any requirements of the relevant Regulatory Authority(ies) having jurisdiction.
	 	 	 
	14.3	 	
SOP
	 	 	 
	14.3.1	 	
Consistent with the above, Baxter and Acambis shall jointly develop
certain procedures with regard to Pharmacovigilance & Field Corrective
Actions (including Recall) within three months of the execution date of
this Agreement.
	 	 	 
	15.0	 	
INDEMNITY & INSURANCE
	 	 	 
	15.1	 	
Due to the unknown risks of the Product, the Seller of the Product shall
use all reasonable endeavours to obtain complete indemnification for all
Parties under this Agreement from the Governmental Authority of Customer’s
nation according to the guidelines agreed upon in Attachment C. In the
event a Customer refuses to provide complete indemnity consistent with
Attachment C, the Seller shall promptly notify the other Party and no
contract shall be executed until the other Party agrees in writing. When
a Government Authority of a Customer’s nation provides indemnification,
the Selling Party shall conduct due diligence to verify that such
indemnification is valid and enforceable.
	 	 	 
	15.2	 	
Baxter agrees to defend, indemnify and hold free and harmless Acambis
Research and its affiliates, directors, officers and employees from any
and all claims or damages (including litigation expenses and attorneys’
fees and costs) of every kind or nature whatsoever arising from acts
and/or omissions of Baxter in the course of this Agreement including,
without limitation, any and all claims arising from third parties in
relation to any activity under the control or in the responsibility of
Baxter. This indemnity shall not apply however, to the extent any such
claims are (a) caused by any act or omission under Acambis responsibility,
including but not limited to any act or omission of third parties under
contractual control of Acambis, or (b) indemnified by Customer according
to Art 15.1.
	 	 	 
	15.3	 	
Acambis agrees to defend, indemnify and hold free and harmless Baxter and
its affiliates, directors, officers and employees from any and all claims
or damages (including litigation expenses and attorneys’ fees and costs)
of every kind or nature whatsoever arising from acts and/or omissions of
Acambis in the course of this Agreement including, without limitation, any
and all claims arising from third parties in relation to any activity
under the control or in the responsibility of Acambis. This indemnity
shall not apply however, to the extent any such claims are (a) caused by
any act or omission under Baxter’s control, including but not limited to
any act or omission of third parties under contractual control of Baxter,
or (b) indemnified by the Customer according to Art. 15.1.
	 	 	 
	15.4	 	
Both Baxter and Acambis Research shall maintain insurance in appropriate
amounts and terms to cover their potential liability with respect to
personal injury or product liability claims related to or arising out of
the Product, including any such insurance as may be required by any
Regulatory Authority(ies) or other law or regulation.
	 	 	 
	15.5	 	
The rights and obligations of the parties under this clause shall survive
the Agreement’s termination, expiration or completion. Each party shall
promptly notify the other of any claim in respect of which the notifying
party intends to claim indemnification under this Article 15. The party
seeking indemnification will not enter into any settlement, which would
admit any fault of the other or place any blame on the Product without the
prior




ACAMBIS CONFIDENTIAL INFORMATION



22







 





	 	 	 
	 	 	
written consent of the other party. Both parties shall cooperate fully in
the investigation of any action, claim or liability covered by this
indemnification, shall be given opportunity to assume their own defense,
including but not limited to the option to be represented in any such
action or proceeding.
	 	 	 
	16.0	 	
CONFIDENTIALITY
	 	 	 
	16.1	 	
Except to the extent as may be authorised in writing, each party agrees
that, during the term of this Agreement and for a period of five (5) years
following its termination or completion, it shall (1) use any Proprietary
Information disclosed to it only for the purpose of performance under this
Agreement, (2) not disclose Proprietary Information to any third party, or
to any employee who does not have a need-to-know such information, and (3)
employ the same standard of care it uses to protect its own Proprietary
Information. To be considered “Proprietary Information” under this clause,
the information must be (a) disclosed in written or tangible form and
appropriately marked as proprietary, or (b) if disclosed orally or
visually, clearly identified as proprietary at the time of disclosure and
summarized in writing within thirty (30) calendar days after such
disclosure. Information shall not be deemed to be proprietary if such
information is already known without restriction to a receiving party; or
is rightfully received without restriction by the receiving party from a
third party having the right to disclose the information; or becomes
publicly available through no wrongful act of the receiving party; or is
hereafter furnished by the disclosing party without a similar restriction
on disclosure; or is independently developed by the receiving party
without breach of this Agreement. The receiving party shall not be liable
for inadvertent disclosure or use of the information received hereunder
if, upon discovery of such, it shall take reasonable steps to prevent any
further inadvertent disclosure or unauthorised use. The receiving party
may make disclosures required by operation of law, provided that the
receiving party shall give the disclosing party reasonable advance notice
to provide the disclosing party an opportunity to contest the requirement
of disclosure. No license is either granted or implied by the conveyance
of Proprietary Information by either party. The Parties further agree that
the obligations set forth above shall survive termination or completion of
this Agreement.
	 	 	 
	16.2	 	
The terms of the above confidentiality provision supersede and replace
the Confidential Disclosure Agreement signed by Baxter Healthcare
Corporation and Acambis Inc. executed 7 October 2002.
	 	 	 
	16.3	 	
Notwithstanding any other provision of this Agreement, neither BHSA nor
BHC grant under this Agreement any rights to any party in its technical
data, computer software, or other intellectual property that may be
developed under or in connection with this Agreement.
	 	 	 
	17.0	 	
NOTICES
	 	 	 
	17.1	 	
A notice under or in connection with this Agreement shall be in writing
and shall be delivered personally or sent by first class post pre-paid
recorded delivery (and airmail if overseas) to the relevant party as
follows:




ACAMBIS CONFIDENTIAL INFORMATION



23







 





	 	 	 	 	 
	 	 	
(a)
	 	If to Acambis:
	 	 	 	 	 
	 	 	 	 	******
	 	 	 	 	Director, Acambis Research Limited
	 	 	 	 	Peterhouse Technology Park
	 	 	 	 	100 Fulbourn Road
	 	 	 	 	Cambridge CB1 9PT UK
	 	 	 	 	 
	 	 	
(b)
	 	If to Baxter:
	 	 	 	 	 
	 	 	 	 	******
	 	 	 	 	Baxter Healthcare Corp
	 	 	 	 	10150 Old Columbia Rd
	 	 	 	 	Columbia, MD 21046
	
	
	
	


	 	 	 	 	*****





	 	 	 
	18.0	 	
TERM AND TERMINATION
	 	 	 
	18.1	 	
This Agreement shall come into force on the date first above written and,
unless earlier terminated, shall remain in force for a period of five (5)
years.
	 	 	 
	18.2	 	
Notwithstanding termination rights stated in other sections of this
Agreement, either Party may terminate this Agreement forthwith by giving a
notice to the other Party in any of the following events :




	 	 	 	 	 
	 	 	
(a)
	 	In the event that the other party commits a
material breach or default of this Agreement and fails to
take action to remedy such breach or default within thirty
days after receipt of written notice from the other Party.
	 	 	 	 	 
	 	 	
(b)
	 	In the event that a party files or consents to
the filing of any petition of bankruptcy or for other relief
under any bankruptcy law for the relief of its creditors, is
adjudicated insolvent or bankrupt, is dissolved or
liquidated, or makes any assignment to its creditors, or a
receiver or similar person is appointed for or in relation to
such a party or a substantial part of its assets or
undertaking.




	 	 	 
	18.3	 	
Accounting for Residual Materials
	 	 	 
	18.3.1	 	
Upon conclusion or termination of this Agreement, Baxter shall return to
Acambis Research (without charge) all materials in its possession to which
Acambis has exclusive title under this Agreement and which were provided
to Baxter by Acambis Research and/or Acambis under this Agreement. Such
materials shall include, but not be limited to, the master virus seed, the
production virus seed, and any other Acambis-proprietary materials and/or
documents used in the manufacture of ACAM 2000 (Acambis) or ACAM 2000
(******).
	 	 	 
	18.3.2	 	
Upon conclusion or termination of this Agreement, Acambis Research
and/or any affiliated company shall return to Baxter (without charge) all
materials in its possession to which Baxter has exclusive title under this
Agreement and which were provided to Acambis Research by Baxter under this
Agreement.




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	18.3.3	 	
Upon conclusion or termination of this Agreement, if Acambis Research or
Baxter has kit components (e.g., diluent, vaccinating needles, or
syringes) that were not sold to a Customer, the Party who paid for the
component shall remove and retain such
component and have no recourse for reimbursement of the cost of such
material or Product against the other Party.
	 	 	 
	18.3.4	 	
Upon conclusion or termination of this Agreement, a Party holding title
to residual vaccine shall have the right, in its sole discretion, to
remove and retain that vaccine at no cost to the other Party. If the
owner of the residual vaccine elects not to remove and retain such
vaccine, that vaccine shall be destroyed by the Party last in possession
of that vaccine with the costs of disposal shared equally between the
Parties.
	 	 	 
	19.0	 	
FORCE MAJEURE
	 	 	 
	19.1	 	
Any delay or failure in the performance of any obligation under this
Agreement by either Party hereto shall be excused if and to the extent
caused, directly or indirectly, by occurrences beyond such party’s
reasonable control. If as a result of force majeure, any party hereto is
precluded from receiving any benefit to which it is entitled hereunder,
the parties shall review the terms hereof so as to restore them to the
same relative positions as those previously obtained hereunder.
	 	 	 
	19.2	 	
The party affected by force majeure shall promptly inform the other of
the occurrence of such force majeure.
	 	 	 
	20.0	 	
INDEPENDENT ORGANIZATIONS
	 	 	 
	 	 	
It is understood and agreed that Baxter and Acambis are deemed to be
independent parties in all their operations and activities hereunder;
that Baxter’s employees performing work hereunder shall deemed to be
Baxter’s employees exclusively with no relation to Acambis and that
Acambis’ employees performing work hereunder shall be deemed to be
Acambis’ employees exclusively with no relation to Baxter. Baxter’s
employees shall be paid by Baxter for all services in connection with
this Agreement and Baxter shall be responsible for all obligations and
reports covering Social Security, unemployment insurance, worker’s
compensation, income tax, and other reports and deductions required by
state, U.S. federal, or foreign law. Acambis’ employees shall be paid by
Acambis for all services in connection with this Agreement and Acambis
shall be responsible for all obligations and reports covering Social
Security, unemployment insurance, worker’s compensation, income tax, and
other reports and deductions required by state, U.S. federal, or foreign
law.
	 	 	 
	21.0	 	
INTELLECTUAL PROPERTY
	 	 	 
	21.1	 	
Neither party shall knowingly do anything to infringe upon or harm the
intellectual property rights of the other party. Each party shall
promptly notify the other of any and all infringements, limitations,
illegal use or misuse, of the other’s intellectual property rights of
which it becomes aware.
	 	 	 
	21.2	 	
Baxter may refer to the Product by the associated Acambis trademarks
applicable to such Product and include such in advertising, marketing, and
promotional materials, provided that such reference is not misleading.
Subject to the preceding sentence and other than the license granted under
provision 8.1.5 of this Agreement, Baxter is granted no right, title, or
license to, or interest in, any trademarks of Acambis. Baxter




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	acknowledges Acambis’ rights in its trademarks and agrees that any use of
such trademarks shall inure to the benefit of Acambis




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	22.0	 	
REGULATORY SUPPORT
	 	 	 
	22.1	 	
ACAM 2000 (Acambis)
	 	 	 
	22.1.1	 	
Acambis, as the holder of BB-IND # 10628, shall amend the CMC
(Chemistry, Manufacturing, and Controls) Section of such IND with lot
release data from the manufacture of the ACAM 2000 (Acambis) vaccine lot
used for the Product while such Product is under IND.
	 	 	 
	22.1.2	 	
Where Baxter performs manufacturing steps that are required to be
described in Acambis’ IND and/or biologics license application (“BLA”) for
ACAM 2000 (Acambis), Baxter shall provide such information (in English or
German) to Acambis as soon as reasonably practicable. Baxter shall not
sell Product to Customers as ACAM 2000 (Acambis) unless Acambis agrees and
such Product conforms to Acambis’ IND and/or BLA on file with the US FDA.
	 	 	 
	22.1.3	 	
Acambis will be responsible for performing the regulatory activities
required by the Regulatory Authorities with respect to the manufacture,
marketing, sale and use of the Product that includes ACAM 2000 (Acambis).
Baxter shall provide regulatory support to assist Acambis in meeting the
requirements of the non-US Regulatory Authorities. Such support will
include, but is not limited to advice and assistance in obtaining and
maintaining European product Marketing Authorization(s) in obtaining and
maintaining product Marketing Authorizations in other non-US countries,
and meeting all regulatory requirements and performing the required
regulatory activities as set forth by the non-US Regulatory Authorities.
	 	 	 
	22.1.4	 	
ACAM 2000 (******)
	 	 	 
	22.1.4.1	 	
For ACAM 2000 (******)
if Acambis elects to hold the
Marketing Authorization after
Baxter has declined to do so,
Acambis will be responsible for
performing the regulatory
activities required by the
relevant Regulatory
Authority(ies) with respect to
the manufacture, marketing, sale
and use of the Product that
includes ACAM 2000 (******).
Baxter shall provide regulatory
support to assist Acambis in
meeting the requirements of the
relevant Regulatory
Authority(ies).
	 	 	 
	22.1.4.2	 	
For ACAM 2000 (******)
where Baxter holds the Marketing
Authorization or where there is
no Marketing Authorization,
Baxter will be responsible for
performing the regulatory
activities required by the
relevant Regulatory
Authority(ies) with respect to
the manufacture, marketing, sale
and use of the Product that
includes ACAM 2000 (******). If
Baxter applies for and obtains a
Marketing Authorization for
Product that includes the ACAM
2000 (******) vaccine, Baxter
shall develop and provide all
documentation required to obtain
and maintain such Marketing
Authorization. Baxter shall
submit all such documentation to
Acambis Research for review
prior to Baxter filing with the
relevant Regulatory
Authority(ies).
	 	 	 
	23.0	 	
GENERAL
	 	 	 
	23.1	 	
Except as stated otherwise in this Agreement, neither this Agreement nor
any right or obligations hereunder shall be assignable by either party
hereto without the prior written approval of the other party, and any
assignment without such prior written consent shall be null and void. In
the case of an assignment to an affiliate of a Party, such consent shall
not be unreasonably withheld or delayed.




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	23.2	 	
The invalidity, illegality or unenforceability of the whole or part of
any provision of this Agreement does not affect or impair the continuation
in force of the remainder of this Agreement. All Attachments are an
integrated part of this Agreement.
	 	 	 
	23.3	 	
No waiver of a breach of any provision of this Agreement shall constitute
a waiver of any other breach of such provision. Failure of any party to
enforce at any time, or from time to time, any provision of this Agreement
shall not be construed as a waiver thereof. The remedies herein shall be
cumulative and additional to any other remedies in law or in equity.
	 	 	 
	23.4	 	
This Agreement and the other agreements referenced herein contain the
entire understanding of the parties hereto with respect to the sale of
Product to Customers, and supersedes all prior discussions, agreements,
understandings with respect to its subject matter, and no condition,
definition, warranty or representation other than those expressly provided
for herein shall be binding upon either party. Any amendments,
modification, change or alteration of this Agreement shall be made in
writing which expressly refers to this Agreement and which is signed by a
duly authorised officer or representative of each of the parties hereto.
All Attachments to this Agreement are an integrated part of this
Agreement.
	 	 	 
	23.5	 	
Baxter shall comply with all applicable laws and regulations inside and
outside of the Territory that from time-to-time apply to this Agreement or
the transactions and activities contemplated by this Agreement. Baxter
shall not knowingly take any action, which will cause Acambis to be in
violation of any law of any jurisdiction inside or outside of the
Territory.
	 	 	 
	23.6	 	
A person who is not a party to this Agreement has no rights under the
Contracts (Right of Third Parties) Act of 1999 or otherwise to enforce any
term of this Agreement.
	 	 	 
	23.7	 	
All disputes arising out of or in connection with this Agreement shall
be, if not settled amicably between the involved parties, will be referred
to the Chief Executive Officer of Acambis PLC and the Chief Executive
Officer of Baxter International Inc. for good faith resolution, for a
period of at least 90 days. During such period, both Parties shall in
good faith explore resolution of the dispute using alternative dispute
resolution techniques before pursuing other remedies. If such dispute is
not resolved by the end of such period (or extension thereto as agreed
upon by the Parties), the Parties shall be free to pursue the legal or
equitable remedies available to them before the ordinary courts of
England.
	 	 	 
	23.8	 	
This Agreement is governed by, and shall be construed in accordance with,
the laws of England and Wales. The Parties irrevocably decree that the
Courts of England have non-exclusive jurisdiction to decide and settle any
dispute or claim arising out of or in connection with this Agreement
(“Proceedings”).
	 	 	 
	23.9	 	
The parties agree that process by which any Proceedings are begun in
England may be served on BHSA and BHC by being delivered to a person at
Baxter Healthcare Ltd, Wallingford Rd, Compton, Near Newbury, Berkshire,
RG20 7QW, United Kingdom, with a copy to BHSA, for the attention of the
Corporate Counsel.
	 	 	 
	23.10	 	
If the appointment of the person mentioned in clause 23.10 ceases to be
effective or such person ceases for any reason to act as process agent for
BHSA or BHC, BHSA and BHC shall immediately appoint a replacement process
agent for the purposes of clause 23.10 and shall immediately notify
Acambis Research of the change in




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accordance with Provision 17. This clause does not affect the right to
serve process in any other manner permitted by law.



The headings in this Agreement do not affect its interpretation.




	 	 	 	 	 
	Signed by	 	 	 	 
	 	 	

	 	 
	 	 	 	 	 
	For and on behalf of Acambis Research Limited	 	 
	 	 	 	 	 
	Name:	 	 	 	 
	 	 	

	 	 
	Date:	 	
27 December 2002	 	 
	 	 	

	 	 
	Signed by	 	 	 	 
	 	 	

	 	 
	 	 	 	 	 
	For and on behalf of Baxter Healthcare SA	 	 
	 	 	 	 	 
	Name:	 	 	 	 
	Date:	 	
13 January 2003	 	 
	 	 	

	 	 
	Signed by	 	 	 	 
	 	 	

	 	 
	 	 	 	 	 
	For and on behalf of Baxter Healthcare Corporation	 	 
	 	 	 	 	 
	Name:	 	 	 	 
	 	 	

	 	 
	Date:	 	
13 January 2003	 	 
	 	 	

	 	 




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ATTACHMENT C




SAMPLE IDEMNIFICATION TEMPLATE



(In this Attachment C, “Purchaser” means the Customer, “Manufacturer” Acambis
Inc., its parent company Acambis PLC, and any of its affiliates, and “Seller”
BHSA)



The Purchaser shall indemnify the (i) Seller, (ii) Manufacturer and (iii) all
subcontractors and affiliates of Seller or Manufacturer that are in any way
involved in the manufacture, filling, labelling, ****** or distribution of the
Product, as well as all officers, employees, directors and principal officials
of all the above entities, on demand, against each loss, liability and/or cost
(including litigation expenses and attorneys’ fees and costs) that any of them
incurs arising from any alleged adverse reaction in a human being which
directly or indirectly arises out of the handling and/or administration of the
Product or directly or indirectly arises out of the release of toxic material
into the environment, including, without limitation, each loss, liability and
cost incurred by any of them as a result of defending or settling a claim
alleging such a liability.



In condition 10.1, “adverse reaction” means anaphylaxis, Lymphadenitis, fever
and malaise, postvaccinal encephalitis, vaccinia necrosum, eczema vaccinatum,
fatality and any other reaction that is not intended, independent of whether
such reaction was foreseeable or not, including, but not limited to:





	 	•	 	adverse reaction resulting from the administration of or exposure to
the Product distributed under the scope of this Contract, irrespective of
when such reaction is manifested;
	 
	 	•	 	the failure of the Product to function as intended;
	 
	 	•	 	the failure of the Product to confer immunity from smallpox;
	 
	 	•	 	any side effects arising from the administration of the Product or any
performance of the Product in a manner not intended.



The rights and obligations of the parties under this clause shall survive the
Agreement’s termination, expiration or completion. The Seller shall notify the
Purchaser as soon as possible of any claim or action against, or any loss by,
the Seller that may be reasonably expected to involve indemnification under
this clause. Each party (other than Seller) subject to indemnification shall
be deemed to be a third-party beneficiary of this Agreement and shall have the
right to maintain suit in its own capacity and name to enforce such
indemnification.




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