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Exhibit 10.212

CONFIDENTIAL   REDACTED VERSION

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

CONTRACT MANUFACTURING AGREEMENT

        THIS CONTRACT MANUFACTURING AGREEMENT (the "Agreement") is made and
entered into as of June 12, 2003 ("Date of Agreement"), by and between:

        Chiron S.r.l., with its registered offices at Via Fiorentina 1, 53100
Siena, Italy,

        and

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

        SynCo Bio Partners B.V., with its registered offices at Paasheuvelweg
30, 1105 BJ Amsterdam-Zuidoost, The Netherlands, hereafter referred to as
"SynCo";

Background

—   Chiron has developed a broad line of novel adult and pediatric vaccines for
viral and bacterial infectious diseases, including but not limited to Chiron's
Meningococcal C conjugate vaccine ("Menjugate®");
—
 
SynCo operates a biopharmaceutical manufacturing plant in Amsterdam, The
Netherlands;
—
 
SynCo has prior to this Agreement provided Chiron services related to the
production of Chiron's Menjugate® designated for the European market on the
basis of that certain contract manufacturing agreement dated July 26, 2001;
—
 
Chiron desires to register and launch Chiron's Menjugate® in the USA;
—
 
Chiron wishes to contract SynCo to provide services related to the production of
Chiron's Menjugate®, for the European and US market, in quantities and at times
to be separately agreed upon between the Parties in accordance with this
Agreement;
—
 
SynCo is willing to use its personnel, expertise and facilities to provide such
services to Chiron in accordance with the terms of this Agreement;
—
 
The Parties shall simultaneously with this Agreement enter into that certain
agreement related to the adjustments to be made to the Plant, in order to have
this facility comply with all US Food and Drug Administration requirements (the
"FDA Compliance Agreement") and any and all obligations of either party under
this Agreement are subject to the other party fulfilling its obligations under
such FDA Compliance Agreement;

        NOW, THEREFORE, in consideration of the premises, the mutual covenants,
terms and conditions hereinafter set forth, THE PARTIES AGREE AS FOLLOWS:

Article 1—Definitions

        For the purpose of this Agreement the following terms shall be defined
as follows:

1.1."Affiliate" means with respect to either Party: any company, entity, joint
venture or similar business arrangement which is controlled by, controlling or
under common control with such Party,

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and shall include without limitation any company fifty percent or more of whose
voting stock or participating profit interest is owned or controlled, directly
or indirectly, by such Party, and any company which owns or controls, directly
or indirectly, fifty percent or more of such Party.

1.2."BPRs" means: the batch production records and other documents providing the
manufacturing history of a batch of a Product.

1.3."Confidential Information" means: (a) all information disclosed by either
Party in writing and designated confidential and (b) all information disclosed
orally by either Party and confirmed in writing and designated confidential by
such disclosing Party within thirty (30) days after such disclosure.

1.4."GMP" means: European Good Manufacturing Practices for Medicinal Products as
in effect from time to time.

1.5."Material" means: the working cell banks and specific reagents as required
for the manufacture of the Products in accordance with the relevant
Specifications, provided that commercially available raw materials are excluded
from Material.

1.6."Parties" and "Party" means: SynCo and Chiron and SynCo or Chiron,
respectively, as the context may require.

1.7."Patents" means all patents owned by or licensed (with a right to
sublicense) to Chiron or any of its Affiliates claiming Technology.

1.8."Plant" means: SynCo's facility located at Paasheuvelweg 30, 1105 BJ
Amsterdam-Zuidoost, The Netherlands.

1.9."Product" or "Products" means: any or all of the vaccine products or
intermediate products thereof listed on Appendix B.

1.10."Quality Agreement" means the quality agreement between the Parties in the
form attached hereto as Appendix F, as the same may be amended by the Parties
from time to time.

1.11."Specifications" means: with respect to each Product, the specifications
for such Product as set forth in Appendix C, as such specifications may be
amended by Chiron from time to time with the written approval of SynCo.

1.12."Technology" means: all inventions, discoveries, procedures, processes,
methods, data, information, results, trade secrets and know-how, whether
patentable or otherwise, owned by or licensed (with a right to sublicense) to
Chiron or any of its Affiliates as of the Date of Agreement or any time during
the term of this Agreement relating to the manufacture of the Products and shall
include, without limitation, the Specifications.

1.13."USGMP" means: United States Good Manufacturing Practices as described in
the US Code or Federal Regulations as in effect from time to time.

Article 2—Manufacture and Delivery of Product

2.1.As from [***] SynCo shall manufacture and supply to Chiron such quantities
of Products as Chiron may from time to time order in accordance with the terms
of this Agreement.

2.2.Attached as Appendix D is Chiron's firm binding order for Products to be
delivered in [***]. SynCo hereby accepts such order. This firm order cannot be
reduced by Chiron. In the event Chiron requires additional Products for the year
[***], Chiron may request SynCo to manufacture such additional Products, but
SynCo may reject or accept such request for additional Products at its sole
discretion, provided, however, that SynCo shall notify Chiron in writing of its
decision

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[***] of receipt of such request from Chiron. Under no circumstances shall SynCo
be obliged to accept such request for additional Products.

2.3.The split between CRM197 and MenC for the years [***] shall be communicated
in writing by Chiron to SynCo no later than the [***], respectively. If such
split has not been communicated in writing to SynCo before the date indicated in
the previous sentence, a firm binding order will have been deemed made with a
spilt as indicated between brackets in Appendix D. For the avoidance of doubt,
the split between CRM197 and MenC for the year [***] has been described in
Appendix D and this split is part of the firm binding order for the year [***]
and cannot be changed.

2.4.For the years [***], Chiron shall order Products in the quantities set out
in Appendix E, provided that Chiron may reduce or increase these quantities by
[***], and provided further that in the event that the Plant [***], Chiron shall
have the right to reduce such quantities by [***] . In the event Chiron requires
more than [***], Chiron may request SynCo to manufacture such additional
batches, but SynCo may reject or accept such request for additional batches at
its sole discretion provided, however, that SynCo shall notify Chiron in writing
of its decision [***] of receipt of such request from Chiron. Under no
circumstances shall SynCo be obliged to manufacture more than [***].

2.5.For the years [***], Chiron shall provide SynCo with firm binding orders and
rolling forecasts as follows. On or before [***], Chiron shall provide SynCo
with a firm binding order for Products to be delivered in the year [***] and a
forecast of Products to be delivered in the years [***]. On or before [***],
Chiron shall provide SynCo with a firm binding order for Products to be
delivered in the year [***] and on or before [***] Chiron shall provide SynCo
with a firm binding order for Products to be delivered in the years [***]. If
Chiron's firm binding order with respect to any of the years [***] has not been
received by SynCo prior to the date it should have been received by SynCo as set
out in this Article 2.5., Chiron will be deemed to have made a firm binding
order in the quantity as set forth in the forecast applicable for the relevant
year(s). If no forecast is applicable to the relevant year, a firm binding order
will have been deemed made in the quantities (and with the split between CRM197
and MenC) as set out in Appendix E. Article 2.4. hereof applies to any and all
firm binding orders and forecasts.

2.6.SynCo shall deliver MenC Products [***]. The dates/periods of manufacture
and delivery of CRM197 Products shall be at SynCo's sole discretion, provided
the manufacture and delivery shall take place within the relevant year and for
the quantities set out in Chiron's firm binding orders.

2.7.Any and all Products shall be delivered by SynCo to Chiron Ex Works (Plant,
Amsterdam, The Netherlands) according to Incoterms 2000 upon payment of the
Products. Chiron guarantees that it shall, within thirty (30) business days from
the date on which SynCo advises Chiron that the Products are available for
delivery and provided that Chiron has paid in full any and all amounts in
respect of such Products, accept delivery of such Products and transfer the
Products from the Plant. Title to the Products shall pass to Chiron upon payment
in full of any and all amounts in respect of such Products. Notwithstanding
anything to the contrary in this Agreement, ultimately 30 days from the date on
which SynCo has advised Chiron that the Products are available for delivery, the
risks with respect to such Products transfers from SynCo to Chiron and SynCo
accepts no responsibility whatsoever with respect to such Products as from such
date.

Article 3—Transfer of Technology and Material

3.1.Chiron hereby grants to SynCo and guarantees that all its Affiliates are
deemed to have granted to SynCo a non-exclusive, [***] license under the Patents
and any and all other rights to for the sole purpose of using the Technology to
manufacture Products solely for Chiron in accordance with the terms and
conditions of this Agreement.

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3.2.Chiron shall provide SynCo with the Specifications and all other relevant
Technology or information necessary or conducive for the purpose of enabling
SynCo to perform its obligations under this Agreement.

3.3.Chiron shall furnish SynCo, [***], with the Material in sufficient
quantities for the purpose of enabling SynCo to perform its obligations under
this Agreement. The Material shall remain the exclusive property of Chiron.
SynCo shall not transfer the Material to any third party. The Material shall be
released by the Quality Assurance officer of Chiron. SynCo shall maintain
records of usage of the Material, and shall inform Chiron of needs for
additional quantities in a timely manner, and return to Chiron any unused
quantities of the Material upon request. Chiron shall provide SynCo with the
Material in a timely manner for the purpose of enabling SynCo to perform its
obligations under this Agreement. A request by SynCo to Chiron to provide
Material is in any way deemed to be made in a timely manner, if such request is
made [***] on which SynCo desires to receive such Material.

3.4.Chiron guarantees that all Material provided to SynCo is accompanied by a
Certificate of Analysis by Chiron's Quality Assurance.

Article 4—Regulatory Affairs and Quality Assurance

General

4.1.SynCo shall exercise all reasonable skill, care and diligence in the
performance of its duties under the Quality Agreement. In the event of a
conflict between the Quality Agreement and this Agreement, this Agreement
prevails.

4.2.SynCo shall exercise all reasonable skill, care and diligence in the
performance of its duties under this Agreement and shall carry out all
responsibilities with recognized professional standards and the requirements of
GMP [***]. SynCo shall obtain and maintain all legally required permits in order
to manufacture the Products in the Plant. SynCo shall at the reasonable request
of Chiron inform Chiron of all permits filed and their status with respect to
approval.

4.3.Chiron shall provide to SynCo the release tests to be performed on the
Products and SynCo shall perform such release testing in accordance with
Chiron's reasonable written instructions.

4.4.Subject to reasonable prior notice, Chiron's designated representatives may
inspect those portions of the Plant used in the production of the Products for
the purpose of determining compliance with GMP [***] and with the terms of this
Agreement at reasonable times during the production campaign of the Products.
SynCo shall provide full cooperation for these inspections.

4.5.Chiron shall have full and final responsibility for the release of each
batch of Product manufactured by SynCo.

Registration and launch of Chiron's Menjugate® in the USA

4.6.The Biological License Application (the "BLA") in respect of Chiron's
Menjugate® shall be prepared and drafted by Chiron. SynCo shall provide Chiron
with all information required for the preparation of the BLA which is related to
the Plant and the manufacturing activities (to be) performed by SynCo, provided
SynCo possesses such information. To the extent that SynCo does not possess such
information SynCo shall use all reasonable endeavours to obtain such information
and provide it to Chiron. The section in such BLA related to manufacturing
activities (to be) performed by SynCo shall be reviewed and, if approved,
initialed by SynCo. Chiron shall have full and final responsibility for the BLA
and for the timely submission thereof with the competent regulatory authorities.

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Article 5—Warranties and Liability

5.1.SynCo warrants that:

a)the Products shall be manufactured, packed, stored and delivered in compliance
with this Agreement and all applicable laws, regulations, and orders, including
GMP and, [***]; without limiting the generality of the foregoing, SynCo shall
obtain and maintain in effect all required governmental permits, licenses, and
approvals applicable to the manufacture of the Products and shall produce the
Products in accordance with all such permits, licenses, orders, applications and
approvals;

b)the Material shall be received and stored in accordance with all applicable
laws, regulations and orders and in accordance with the relevant specifications;

c)on the date of delivery thereof, the Products shall conform to the
Specifications; and

d)it will not carry on activities in the Plant which could reasonably prevent
the Products from being manufactured in accordance with all applicable laws,
regulations, and orders, including GMP, [***].

EXCEPT AS OTHERWISE EXPRESSLY PROVIDED HEREIN, SYNCO MAKES NO REPRESENTATIONS,
WARRANTIES, OR GUARANTEES, EXPRESS OR IMPLIED, FOR FITNESS FOR A PARTICULAR
PURPOSE OR MERCHANTABILITY OF ANY OF THE PRODUCTS MANUFACTURED BY IT. SYNCO
EXPRESSLY DISCLAIMS ANY AND ALL RESPONSIBILITY IN RESPECT OF THE FITNESS FOR A
PARTICULAR USE OR MERCHANTIBILITY OF ANY OF THE PRODUCTS MANUFACTURED BY IT.
SYNCO SHALL NOT BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES IN ANY CASE OF
NONCONFORMITY OF THE PRODUCT. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING FROM ANY ALLEGED OR ACTUAL
BREACH OF THIS AGREEMENT. WITHOUT LIMITING THE FOREGOING, SYNCO DOES EXPRESSLY
NOT WARRANT THE YIELD THAT WILL RESULT FROM THE MATERIAL OR THE YIELD OR
QUANTITY OF PRODUCT PER BATCH.

5.2.SynCo shall as soon as reasonably possible replace, free of charge, any
defective or non-conforming Product supplied to Chiron, provided Chiron notifies
SynCo in writing upon discovery of such defect or non-conformity within a period
of sixty days after SynCo's Quality Assurance has approved the Product and
provided further Chiron allows SynCo to evaluate the claim and to test the said
quantity of Product within a reasonable period of time, but not to exceed sixty
days. Replacement of the Product by Synco pursuant to this paragraph 5.2 shall
be the sole remedy of Chiron against SynCo for defective or non-conforming
Product.

5.3If the Parties disagree whether such Product is defective or non-conforming,
then the Product in dispute will be tested and further analyzed by a qualified
independent testing laboratory reasonably acceptable to both Parties. Such
laboratory's testing will determine, using representative samples, whether the
quantity of the Product is defective or non-conforming with the Specifications.
The resulting determination of the laboratory will be final and binding on SynCo
and Chiron. SynCo will bear the cost of such testing if the testing demonstrates
that the Product is defective or non-conforming and Chiron will bear the cost if
the testing demonstrates the Product is neither defective nor non-conforming.

5.4.SynCo shall indemnify, defend and hold harmless Chiron and its Affiliates
from and against any and all losses, claims, damages or liabilities (including
but not limited to reasonable attorney's fees) arising from or relating to
(a) any breach by SynCo of its representations, warranties or covenants under
this Agreement; or (b) any negligence or intentional wrongdoing of SynCo or its
employees directly related to the cause of such losses, claims, damages or
liabilities to the extent

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any such losses, claims, damages or liabilities (including but not limited to
reasonable attorney's fees) referred to in this Section 5.4 do not arise from an
act or omission indemnified by Chiron pursuant to Section 5.5 hereof; all of the
foregoing provided that in the event of defective or non-conforming Product,
SynCo shall not be liable or obliged to indemnify, defend or hold harmless
Chiron for any losses, claims, damages or liabilities, whatsoever; in such
event, Chiron is only entitled to replacement of the defective or non-conforming
Product.

5.5.Chiron shall indemnify, defend and hold harmless SynCo, its employees and
its Affiliates and employees from and against any and all losses, claims,
damages or liabilities (including but not limited to reasonable attorney's
fees), arising from or relating to (a) any use, including in clinical trials, or
sale by Chiron, SynCo or any third party of any Product supplied by SynCo
hereunder; (b) any allegation or claim by any third party of infringement of its
intellectual property rights by reason of or relating to the manufacture, use or
sale of Products by SynCo, Chiron or any of its Affiliates or any third party;
(c) any breach by Chiron of its representations, warranties or covenants under
this Agreement; (d) any Material or other material or information provided by
Chiron to SynCo or (e) any negligence or misconduct of Chiron or its employees
or its Affiliates or their employees directly related to the cause of such
losses, claims, damages or liabilities (including but not limited to reasonable
attorney's fees) to the extent any such losses, claims, damages or liabilities
(including but not limited to reasonable attorney's fees) referred to in this
Section 5.5 do not arise from any act or omission indemnified by SynCo pursuant
to Section 5.4 hereof.

5.6.Any person seeking indemnity pursuant to this section (the "Indemnified
Party") shall notify the Party from whom indemnification is sought (the
"Indemnifying Party") in writing promptly upon becoming aware of any claim,
threatened claim, damage, loss, suit, proceeding or liability ("Claim") to which
such indemnification may apply. Failure to provide such notice shall constitute
a waiver of the Indemnifying Party's indemnity obligations hereunder if and to
the extent the Indemnifying Party is materially damaged thereby. The
Indemnifying Party shall have the right to assume and control the defence of the
Claim at its own expense. If the right to assume and control the defence is
exercised, the Indemnified Party shall have the right to participate in, but not
control, such defence at its own expense and the Indemnifying Party's indemnity
obligations shall be deemed not to include attorneys' fees and litigation
expenses incurred by the Indemnified Party after the assumption of the defence
by the Indemnifying Party. If the Indemnifying Party does not assume the defence
of the Claim, the Indemnified Party may defend the Claim; provided, that the
Indemnified Party will not settle or compromise the Claim without consent of the
Indemnifying Party, which consent will not be unreasonably withheld. The
Indemnified Party shall co-operate with the Indemnifying Party and will make
available to the Indemnifying Party all pertinent information under the control
of the Indemnified Party.

Article 6—Considerations and Payments

6.1.As payment in full for Products supplied hereunder or firm binding orders
for such Products, Chiron shall pay to SynCo [***] as set forth in Appendix A.
The prices as set forth in Appendix A shall be [***], for the first time on
[***] by increasing such price with [***]. Any and all prices are to be
increased with the [***].

6.2The Parties recognize and agree that the prices set forth in Appendix A are
calculated on the assumption that the Products shall be manufactured [***].

6.3A [***] will be payable [***]. SynCo shall send Chiron an invoice in respect
of this amount at least thirty days before such payment is due.

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6.4SynCo shall invoice Chiron [***]. Payment shall be made by Chiron within
thirty (30) days from receipt of the relevant invoice. Delivery of the Products
shall only take place after payment by Chiron in full of any and all amounts in
respect of such Products.

6.5Any and all amounts to be paid under this Agreement that are not paid at the
relevant payment date shall bear interest at a rate of [***] or part of a month
that such amount remains unpaid. Interest shall be compounded on a [***].

6.6Upon the occurrence of an event referred to in Article 8.2(i), any and all
amounts then owed under this Agreement, notwithstanding SynCo's right to claim
additional damages, if any, become immediately due and payable.

6.7Neither Party is entitled to any set-off, recoupment, withholding or any
other similar action in respect of any payments to be made under this Agreement.

Article 7—Confidentiality and Intellectual Property

        A Party receiving Confidential Information from the other Party or
developing Confidential Information hereunder shall not disclose such
Confidential Information to any third party or otherwise for a period extending
ten (10) years following expiration or earlier termination of this Agreement,
except as follows:

(a)to the extent such information is or becomes general public knowledge through
no fault of the recipient Party; or

(b)to the extent such information can be shown by contemporaneous documentation
of the recipient Party to have been in its possession prior to receipt thereof
hereunder; or

(c)to the extent such information is received by the recipient Party from a
third party without any breach of an obligation to the disclosing Party; or

(d)to the extent required by law, by local authorities for regulatory purposes
or is necessary to perform its obligations under this Agreement, in which case
the recipient Party may disclose the information if the recipient Party gives
the other Party prior notice of such disclosure and an opportunity to comment
upon the content of the disclosure. However, SynCo shall have the right, at all
times and without the obligation to give notice to Chiron, to use information
related to its Plant for its own business purposes and Chiron shall have the
right, at all times and without the obligation to give notice to SynCo, to use
the information related to the Products for its own business purposes.

For the avoidance of doubt: It is understood that SynCo purchased the Plant and
certain related equipment, including computers and other information technology
systems, from an Affiliate of Chiron, and that prior to such purchase the Plant
and equipment were utilized by Chiron and/or its Affiliates for the manufacture
of Products. It is further understood that certain employees of SynCo formerly
were employees of an Affiliate of Chiron and were engaged directly or indirectly
in the manufacture of Products. Notwithstanding anything to the contrary
contained herein, and in particularly notwithstanding paragraph (b) above, all
information relating the Specifications, Technology or manufacture of the
Products which exists as of the date of this Agreement shall be owned solely and
exclusively by Chiron and shall not be disclosed by SynCo at any time during the
term of this Agreement or for a period of ten years following the expiration or
earlier termination of this Agreement, provided that information relating to the
manufacture of the Products that is not exclusive to the Products shall not be
deemed to be owned by Chiron and the prohibition to disclose such information
shall not apply.

Each Party shall use Confidential Information received from the other Party
solely for the purposes of this Agreement and for no other purpose whatsoever.

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Article 8—Term of Agreement

8.1The term of this Agreement shall commence as of the Date of Agreement, and
will continue until [***], unless terminated earlier in accordance with this
Agreement.

8.2Either Party may terminate this Agreement prior to [***] (i) if the other
Party is declared bankrupt ("failliet"), files for bankruptcy, is adjudged
insolvent or files for suspension of payments ("surséance van betaling") or any
other similar circumstance under applicable law or (ii) if the other Party
breaches any material obligation of this Agreement and such Party does not fully
remedy such default within sixty (60) days after having received a written
notice from the Party asserting the breach.

8.3Chiron may terminate this Agreement in the event that SynCo, without Chiron's
prior written agreement, [***] in accordance with the terms of this Agreement in
any calendar year. This termination right shall be exercisable by Chiron in each
case only on or before December 31 of the relevant calendar year.

8.3Article 5.4, 5.5, 5.6, 7,9.2 and 9.6 survive termination of this Agreement.
Furthermore, termination of this Agreement will not relieve Chiron of its
obligations to pay SynCo for Products previously supplied hereunder and for
commitments which arise directly out of firm purchase orders for Products.

Article 9—Additional Terms

9.1Obligations subject to FDA Compliance Agreement. Any and all obligations of
each Party under this Agreement are subject to fulfillment by the other Party of
its obligations under the FDA Agreement.

9.2No guarantee SynCo as regards approvals. SynCo does not make and has not made
and may not be deemed to make or have made any representation, warranty or
guarantee that approval from the FDA or any other competent regulatory authority
will be obtained for Chiron's Menjugate®. The responsibility for obtaining the
approval by the FDA and other competent regulatory authorities, if any, shall
solely and exclusively rest on Chiron. This Agreement may not be construed or
interpreted so as to transfer to SynCo any responsibility or part thereof for
obtaining such approvals.

9.3.Non-Waiver. Without prejudice to Article 5.6 hereof, the failure by any
Party at any time to enforce any of the terms or provisions or conditions of
this Agreement or exercise any right hereunder shall not constitute a waiver of
the same or affect the validity of this Agreement or any part hereof, or that
Party's rights thereafter to enforce or exercise the same. No waiver by a Party
shall be valid or binding, except if in writing and signed by a duly authorized
representative of the waiving Party.

9.4.Severability. In case one or more of the provisions contained in this
Agreement shall, for any reason, be held invalid, illegal or unenforceable in
any respect, such holding shall not affect any other provisions of this
Agreement, but this Agreement shall be construed by limiting such provision to
such extent as would nearly as possible reflect the intent, purpose and economic
effect of such provision, or, if such is not possible, by deleting such
provision from this Agreement, provided that the remaining provisions reflect
the intent of the Parties, as evidenced by this Agreement as a whole.

9.5.Captions. All titles and captions in this Agreement are for convenience only
and shall not affect its interpretation.

9.6.Law and Arbitration. This Agreement shall be governed, construed and
interpreted by the laws of the Netherlands. The Parties agree that all disputes
between them arising out of or relating to this

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Agreement shall be settled by arbitration in accordance with the Rules of
Conciliation and Arbitration of the International Chamber of Commerce by three
arbitrators appointed in accordance with such Rules. The arbitration proceedings
shall take place in Amsterdam, The Netherlands if initiated by Chiron and in
Milan, Italy if initiated by SynCo and shall be conducted in the English
language. Judgment on the award may be issued by and enforced by any court of
competent jurisdiction.

9.7.Entire Understanding. This Agreement (including appendices) is the entire
understanding and agreement between the Parties relating to the subject matter
hereof and supersedes (except as provided herein) any and all prior
arrangements, understandings, and agreements between the Parties whether written
or oral relating thereto. For the sake of completeness, it is acknowledged and
agreed that the provisions of that certain contract manufacturing agreement
dated July 26, 2001 remain valid for the Products to be manufactured in the year
2003. No amendments, changes, or modifications of the terms of this Agreement
shall be valid or binding unless made in writing and signed by the duly
authorized representatives of each Party.

9.8.Independent Status of Parties. Each Party is an independent party acting in
its own name and for its own account. Neither Party has any authority to act as
an agent or representative of the other, or to contract in the name of, or
create or assume any obligation against, or otherwise legally bind, the other
Party in any way for any purpose, unless agreed separately in writing. All costs
and expenses connected with each Party's activities and performance under this
Agreement unless otherwise separately agreed or provided for in this Agreement
are to be borne solely by the Party incurring such costs and expenses.

9.9.No Transfer of Rights or Obligations. Neither of the Parties may transfer
any or all of its rights or obligations under this Agreement to any third party,
without the prior written consent of the other Party.

9.10.Press Release. The Parties agree that neither Party shall disclose the
existence of or the contents of this Agreement to any third party without the
prior written consent of the other Party.

9.11.Joint and Several Liability. Chiron S.r.l. and Chiron Behring GmbH & Co
shall be jointly and severally liable for the obligations of Chiron under this
Agreement.

        IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives:

 
   
Chiron S.r.l.:   SynCo Bio Partners B.V.:
/s/  JOHN LAMBERT      

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John Lambert Dr.
President, Chiron Vaccines
 
/s/  MIC N. HAMERS      

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Mic N. Hamers
Managing Director
Chiron Behring GmbH & Co:
 
 
/s/  JOHN LAMBERT      

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John Lambert
President, Chiron Vaccines
 
 

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APPENDIX A

COST OF CERTAIN PRODUCT

        The [***] of dried purified MenC polysaccharides amounts to [***].

        The [***] of CRM197 amounts to [***].

        These prices shall be [***], for the first time on [***], in accordance
with Article 6 of the Contract Manufacturing Agreement.

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APPENDIX B

LIST OF PRODUCTS

MEN C polysaccharides
CRM197

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APPENDIX C

OPERATING PROCEDURES AND SPECIFICATIONS

MF-MFS-MEC-000 Master Formulation Document MenC polysaccharide

This document lists all materials, documents, including all BPRs and control
methods and equipment for the production of MenC

MF-MFS-CRM-000 Master Formulation Document for CRM197

This document lists all materials, documents, including all BPRs and control
methods, and equipment for the production of CRM197

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APPENDIX D

FIRM ORDERS

Campaign of [***]

[***]
[***]

Campaign of [***]

A combined total of [***]

Campaign of [***]

A combined total [***]

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APPENDIX E

QUANTITIES FOR THE YEARS [***]

Campaign of [***]

A combined total of [***]

Campaign of [***]

A combined total of [***]

Campaign of [***]

A combined total of [***]

Campaign of [***]

A combined total of [***]

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APPENDIX F

INTERCOMPANY QUALITY AGREEMENT

        Chiron Vaccines

Chiron s.r.l., Siena, Italy and Chiron Behring GmbH & Co., Marburg, Germany
(hereafter called "Chiron")

Approved by:       Date: 12. June 2003
/s/ Ludger Schwenen
 
 
 
 
Name:    Ludger Schwenen
 
 
Title:    VP Quality Operations
 
 
AND
Synco Bio-partners B.V.,
Amsterdam, The Netherlands
(hereafter called "Synco") Approved by:       Date: 20 June 2003
/s/ Rob Sprenkels
 
 
Name:    Rob Sprenkels
 
 
Title:    Director Quality Affairs
 
 

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1.QUALITY AGREEMENT

        1.1   Scope:

        1.1.1 This agreement defines the Joint Quality Systems between SYNCO and
CHIRON for the production and control of the products and activities detailed
the Contract Manufacturing Agreement (to which this document is an appendix).

        1.1.2 Responsibility of Quality Assurance, Quality Control and other
operational departments for the products and activities detailed in the Contract
Manufacturing Agreement shall be defined by CHIRON and SYNCO as set forth in
this document or in standard operating procedures agreed upon by the parties
from time to time.

        1.2   Guiding Principles:

        1.2.1 The responsibilities of the Manufacturer (SYNCO) include
production and testing of product in compliance with license requirements,
cGMP's and specifications, as set forth in the provisions that follow.

        1.2.2 The Responsibilities of the purchaser (CHIRON) include assuring
conformance of product to regulatory requirements for their licensed territory
through oversight and activities, as set forth in the provisions that follow.

        1.2.3 It is in both parties' interest to collaborate on overall product
performance to assure the consistent quality, integrity, purity and stability of
the product.

        1.2.4 This agreement shall be incorporated within and constitute a part
of the supply agreement between the two companies.

        1.2.5 In the event of a conflict between any of the provisions of the
Quality Agreement and the Contract Manufacturing Agreement, the provisions of
the Contract Manufacturing Agreement shall govern.

2.ADMINISTRATIVE INFORMATION

        2.1   CHIRON and SYNCO contact names: See the listing at the end of this
agreement. This listing will be reviewed semiannually.

        2.2   Organizational Structure

        2.2.1 Any significant change in key personnel relevant to the
manufacture of the Products at the plant or the respective headquarters
involving the Quality department or quality functions for either parties will be
communicated to the other as soon as reasonably possible.

        2.2.2 Any change in key personnel relevant to the manufacture of the
Products of a critical operation (e.g. production, quality, and validation) of
either party will be communicated to other in writing as soon as reasonably
possible.

        2.2.3 Each party to maintain information on and communicate to the other
party within 1 day identification of debarment of any individuals involved in
the manufacture or control of the product.

        2.3   Technical Coordination Meeting.

        2.3.1 A Technical Coordination Meeting(TCM) will be established. The
meeting will be co-chaired by representatives from both parties. Meeting members
to be named by each company. Permanent members include, site head(s) of Quality,
Manufacturing, (other members from QC, Regulatory Affairs, validation and
logistics may be included as the need arises).

        2.3.2 The TCM will provide oversight for product quality. It will meet
on an as required (but normally before the start of each campaign and in the
event of issues) and as agreed to by both parties. The TCM will be the forum to
resolve quality matters. This board does not replace the

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role and responsibility of the respective SYNCO or CHIRON Quality Assurance
function to disposition product as defined in SOP's.

        2.3.3 The TCM will also review such information as, performance,
deviations, change control, continuous improvement to be agreed upon by both
parties.

        2.4   Person in the Plant (PIP)

        2.4.1 SYNCO to provide sufficient facilities for CHIRON PIP

        2.4.2 SYNCO will allow the CHIRON PIP access to the facility at any time
reasonably requested, during manufacturing and testing operations for product
for the purposes of observing various operations, assisting in any problem
solving, facilitating additional tasks and communicating issues to others at
CHIRON. Upon mutual agreementas circumstances require, additional CHIRON
personnel to be provided access to manufacturing and testing operations as part
of a collaborative effort as required to accomplish the specific function, i.e.,
investigations. The PIP will facilitate these requests and coordination with
SYNCO.

3.DURATION OF AGREEMENT

        3.1   The Quality Agreement will be reviewed as necessary to ensure that
the roles and responsibilities reflect current practice. This agreement can be
modified as needed with the written approval of both parties. The Contract
Manufacturing Agreement will not be updated as changes occur, as these changes
will be governed by the change control system and subsequent documentation
updates.

        3.2   This Quality Agreement will effective upon and will expire with
the termination of the supply agreement except for circumstances set forth in
the agreement.

4.MANUFACTURING AND LOGISTICS

        4.1   General

        4.1.1 The definition of "cGMP" shall mean the regulatory requirements
for current good manufacturing practices promulgated by the FDA under the FD&C
Act 21 C.F.R. 210 et seq. and under the PHS Act 21 C.F.R. 600-610, and the
applicable regulatory guidance documents and current industry practice
promulgated by the European Committee and the Canadian Health Protection Branch
as the case may be, as the same may be amended from time to time.

        4.1.2 SYNCO agrees not to subcontract any of the manufacturing, testing,
release and/or handling of the product unless prior written agreement has been
obtained from CHIRON. Refer to Change Management, section 9.

        4.2   Premises

        4.2.1 The premises and equipment used to manufacture the product will be
maintained according to current regulatory requirements and in accordance with
the controlled documentation.

        4.2.2 Manufacturing of the product will be conducted in a suitably
controlled environment and such facilities will be regularly monitored for
parameters critical to the process to demonstrate compliance with cGMP
regulations and guidelines and any conditions registered in the Biologics
License Application (BLA) and other global manufacturing authorizations.

        4.2.3 . SYNCO will ensure that CHIRON proprietary information and
documentation will be controlled in order to maintain confidentiality
obligations.

        4.3   Raw Materials, Cell Bank and Product Samples

        4.3.1 Raw materials used in the manufacturing or testing of the product
must be approved and tested in accordance with documents jointly reviewed and
approved by CHIRON and SYNCO.

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        4.3.2 SYNCO will implement appropriate system to maintain certification
of raw materials, in process materials, chemicals and excipients used in the
manufacture of product. Synco shall assure each lot is in full compliance with
the approved specifications.

        4.3.3 Materials procured by SYNCO

        4.3.3.1 SYNCO will procure all materials for use in the product from
mutually approved vendors and in full compliance with the specifications and
SOPs mutually agreed upon by SYNCO and CHIRON

        4.3.3.2 CHIRON and SYNCO will jointly approve all vendors or suppliers
of critical raw materials, reagents, or components used in the manufacture and
testing as well as all contract testing of product (collectively, "Third Party
Vendors"). The procedures relating to documentation of approval are to follow
procedure described in Section 6.1 and any vendor or supplier changes are to
follow change control procedures described in Section 9.

        4.3.3.3 SYNCO is responsible for ensuring that all materials are
received, stored, segregated and used correctly, and all materials are
appropriately tested upon receipt and are released prior to use. SYNCO is also
responsible for holding the relevant Certificate of Analysis, Certificate of
Compliance and/or certification of origin (as appropriate) for the materials.

        4.3.3.4 SYNCO is responsible for ensuring appropriate separation and/or
segregation of any materials that may present potential hazard to the materials
used in the product and/or the production of the product.

        4.3.4 Materials Provided by CHIRON for SYNCO

        4.3.4.1 CHIRON is responsible for ensuring that any materials or
components provided by CHIRON for use in the product are in full compliance with
the specifications registered. CHIRON will provide SYNCO with relevant
information on storage conditions and holdtimes.

        4.3.4.2 CHIRON will provide SYNCO the necessary information for SYNCO to
receive and disposition any raw material or component supplied by CHIRON prior
to or with a scheduled receipt.

        4.3.4.3 SYNCO is responsible for receiving and appropriately storing the
working seeds and providing sufficient and suitable storage facility. SYNCO will
notify CHIRON if there is a deviation associated with the working seed shipping,
receipt or testing. Refer to Deviation section 7.3. SYNCO will use reasonable
effort that during storage, deterioration, interference, theft, product
contamination, or mixture with any other materials shall take place.

        4.4   Product and Lot Numbers

        SYNCO will assign a unique part number and or lot number to each media
or solution, in-process intermediate and product lot produced. The SYNCO part
and lot numbers are recorded on each batch record. The numbering procedures will
allow for unique, traceable identifiers, which are compatible with CHIRON and
SynCo inventory management systems.

        4.5   Manufacturing and Equipment Data

        4.5.1 SYNCO is responsible for keeping records of equipment usage,
cleaning, testing, pressure holds, etc. and any maintenance/calibration
performed.

        4.5.2 SYNCO will provide CHIRON with access to manufacturing equipment
data relevant to the manufacture and testing of the PRODUCTS upon request.

        4.6   Storage and Shipment of THE PRODUCTS

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        4.6.1 SYNCO will provide sufficient and suitable storage facilities that
meet the storage specifications for the product as documented and agreed upon in
either batch records or SOPs.

        4.6.2 The product will be suitably packaged for transit as detailed and
agreed in an agreed SOP. CHIRON and SYNCO will collaborate in the logistics of
performing shipping validation(s) and the ongoing use of temperature monitors.

        4.6.3 SYNCO Quality will assure that only released material meeting
mutually agreed predefined requirements is shipped for further processing.

5.QUALITY CONTROL

        5.1   General

        5.1.1 The testing activities for the product that are to be performed by
SYNCO will be documented in jointly approved SYNCO specifications. SYNCO is
responsible for performing validated, cGMP testing. CHIRON will provide
validated test methodology.

        5.1.2 Testing on SYNCO manufactured product, or intermediates will be
performed in accordance with product specifications and SOPs that have been
jointly approved by CHIRON and SYNCO. In addition, any decision to implement any
new analytical methods or testing with respect to the product will in each case
be a decision and mutual agreement of both parties as outlined by Change
Management (Section 9).

        5.2   In-Process and product Testing

        5.2.1 SYNCO will perform testing of in-process intermediates and of the
PRODUCTS using specifications and methods of analysis that have been mutually
approved by SYNCO and CHIRON. Routine samples required for both companies test
requirements will be identified in the batch records and/or SOPs.

        5.3   QC Reporting Results

        5.3.1 SYNCO's Quality Assurance will sign the Certificates of Analysis
confirming that the product has been tested, results have been reviewed and
approved from a relational and technical perspective and meet the requirements
of the product specifications.

        5.4   Retention Samples

        5.4.1 SYNCO will store a quantity of THE PRODUCTS as retention samples.
The amount of retention samples will be agreed upon. CHIRON may also retain
samples at its own discretion.

        5.5   Out-of-Specification (OOS) Investigations:

        5.5.1 SYNCO is responsible for investigating any testing performed by
SYNCO that produces a result that fails to meet a specification. Each
investigation will follow SYNCO procedures and the procedures recommended by
regulatory agencies. See section 6.3.

        5.5.2 SYNCO will notify CHIRON as soon as reasonably possible of any
confirmed test result that is out of specification; for OOS which may impact
material already released, SYNCO to notify CHIRON within 24 hours. These test
results will be handled per section 6.3.

6.QUALITY ASSURANCE

        6.1   Documentation

        6.1.1 Product Specific Master Batch Records and SOPs

        6.1.1.1 SYNCO is responsible for creating the product specific
manufacturing and testing master documentation.

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        6.1.1.2 CHIRON and SYNCO will jointly approve each document version of
product specific raw materials and product specifications, master batch records
and test method SOPs prior to its use in manufacturing or testing.

        6.1.1.3 Changes to previously approved documents will be handled as
outlined by Change Management (see section 9).

        6.1.2 General SOPs: SYNCO is responsible for creating and maintaining
all SOPs and other documentation at SYNCO required to support cGMP operations at
SYNCO. CHIRON will be allowed to review such SOPs either on site or upon
request.

        6.2   Deviations and Investigations

        6.2.1 Any deviation from the process and SOPs during manufacture,
storage or testing must be appropriately explained, investigated, documented,
and approved in the batch records or analytical records. The deviation
documentation must identify the cause and the corrective action, where
appropriate, and must assess product impact with respect to product quality.

        6.2.2 SYNCO will communicate to CHIRON any batch or batch related
component that contains a major process or testing deviation or confirmed OOS
where the deviation has the likely potential to impact product quality as soon
as reasonably possible.. SYNCO will also communicate as soon as reasonably
possible to CHIRON any significant facility or product trend investigation that
has the potential to impact product quality or product supply.

        6.2.2.1 Where CHIRON performs testing, CHIRON is responsible to notify
SYNCO of any batch or associated batch of product that contains a major process
or testing deviation or confirmed OOS where the deviation has the likely
potential to impact product safety, efficacy or quality as soon as reasonably
possible.

        6.2.3 Some deviations, confirmed OOS and/or failures may require that
additional testing, stability, or validation be conducted. This work will be
performed as agreed upon in writing by all the parties. SYNCO will not perform
such additional testing on any batch of product without prior written approval
from the CHIRON Quality. Testing performed according to SOPs in order to confirm
an OOS does not require CHIRON prior approval.

        6.2.4 Where a major investigation is open greater than 30 days from
initiation, SYNCO Quality will provide to CHIRON Quality an interim report on
day 31 and regularly there after until closure of the investigation. For all
others, tracking and reporting will be done in accordance with site SOP's.

        6.2.5 Both companies will notify one another within 24 hours of
discovery if any problems are discovered that may impact product batch(s)
previously released and/or shipped.

        6.3   Disposition of Product (Batch Release or Rejection)

        6.3.1 SYNCO Manufacturer's Release

        6.3.1.1 Manufacturer's Release: SYNCO's QualityAssurance, upon
acceptable review and completeness of the batch documentation of operations
performed by SYNCO, will release the batch for shipping to Chiron.

        6.3.2 License Holder's Product Release, where the license holder is the
CHIRON.

        6.3.2.1 CHIRON Quality is responsible for the regulatory release of the
THE PRODUCTS according to CHIRON internal procedures following review of the
SYNCO documentation. CHIRON will forward a copy of THE PRODUCT final release
notices to SYNCO.

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        6.3.3 Product Release Issues

        6.3.3.1 THE PRODUCTS—Any problem discovered prior to release by CHIRON
or SYNCO that may be likely to cause rejection or hold of the product will be
communicated to the other party as soon as reasonably possible. Any subsequent
rejection by CHIRON shall occur within 60 days from CHIRONs review of the SYNCO
manufacturing documentation unless another time frame is mutually agreed upon.

        6.3.3.2 In the case of latent defects (defects not evident at the time
of release), SYNCO and CHIRON will communicate regarding any such defect and any
possible rejection will occur within 30 days from discovery unless another time
frame is mutually agreed upon. SYNCO and CHIRON will work collaboratively to
achieve a resolution.

        6.3.3.3 When the product release issue is discovered by SYNCO and the
SYNCO rejects the lot, then the lot is rejected. CHIRON cannot release a lot
that SYNCO has rejected.

        6.3.3.4 When CHIRON identifies a product disposition issue a joint
investigation would be conducted, the product disposition would be mutually
determined at the conclusion of that investigation. Also refer to section 8.3
Non-Conformity Dispute Resolution.

        6.3.4 Batch Rejection

        6.3.4.1 SYNCO may terminate the processing of an in process intermediate
without prior notification to CHIRON. SYNCO will notify CHIRON of any batch or
portion of batch of Product being considered for rejection by SYNCO. If CHIRON
finds a batch or portion of a of Product unacceptable, CHIRON will reject and
forward a copy of the rejection notice to SYNCO, stating the reason to reject
the lot(s).

        6.4   Records Retention

        6.4.1 SYNCO will retain all of its manufacturing batch records and all
referenced documents, production procedures, testing records and methods and
shipping records of product in accordance with SYNCO record retention
requirements and CFR 211.180d and for not less than 10 years.

        6.4.2 At least 30 days prior to record destruction, SYNCO will notify
CHIRON in writing. CHIRON may request that batch records and associated
documentation be forwarded to CHIRON for archiving.

7.REGULATORY COMPLIANCE

        7.1   Regulatory Documentation

        7.1.1 Regulatory Affairs from CHIRON will assess regulatory strategy and
plans for filings or other regulatory correspondence or requests.

        7.1.2 CHIRON is responsible for ensuring all appropriate regulatory
filings and export documentation is filed with, and approved by, Regulatory
Agencies prior to shipment.

        7.1.3 The CHIRON and SYNCO technical coordination meeting (TCM) will act
as the point of contact with Regulatory Affairs regarding issues that impact the
registration information for the product. CHIRON will be responsible for
assigning regulatory categories for change notifications with consultation with
SYNCO.

        7.1.4 SYNCO will provide CHIRON in a timely manner with a copy of any
SYNCO manufacturing and control records for product or materials which are
required for any regulatory filings. Such records will be in SYNCO standard
formats unless otherwise agreed upon by CHIRON and SYNCO.

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        7.1.5 SYNCO will provide CHIRON with all documents reasonably requested
relating to any FDA or other regulatory authority pre-approval inspection of the
SYNCO Facility for CHIRON product or processes. SYNCO will work collaboratively
with CHIRON on reaching resolution to any questions, pre-approval or
post-approval commitments.

        7.1.6 CHIRON shall review relevant sections of regulatory submissions
with SYNCO prior to their submission. CHIRON shall provide a copy of relevant
sections of final regulatory submissions to SYNCO for reference during
inspections.

        7.1.7 For Annual Report generation, refer to Section 11.2.

        7.1.8 As required, SYNCO will maintain a Site Master File or equivalent
for their facility and allow CHIRON reference to such documents upon request.

        7.2   Regulatory Inspections and Correspondence

        7.2.1 SYNCO will notify CHIRON of any product specific regulatory
inspections that may involve the product and permit a representative from CHIRON
to be present, if requested by CHIRON. The role of the representative would be
defined and mutually agreed upon.

        7.2.2 Agreement should be reached between CHIRON and SYNCO prior to
making any commitment to any regulatory agency regarding the product.

        7.2.3 Each party will promptly notify and provide copies of any
regulatory correspondence directly relating to manufacturing activities by SYNCO
along with any other documentation received or prepared on the product to the
other party as soon a reasonably possible after receipt.

        7.2.4 Each Party will notify the other Party in a timely manner of any
meetings or substantive discussions with the FDA, EMEA, or any other regulatory
authority that directly relate to the manufacture of THE PRODUCTS, supply and/or
control of the product, and that the other Party will have the right to but not
the obligation to have at least one representative participate in such meetings
or discussions.

        7.3   Right to Audit

        7.3.1 SYNCO will permit CHIRON at reasonable intervals and with
reasonable prior notice to SYNCO and during SYNCO's normal business hours to
review and audit at the SYNCO Facility, provided manufacture and /or testing of
the PRODUCTS is ongoing. Such reviews and audits will include any systems,
original batch records and other primary documents and any areas of the SYNCO
Facility and any other laboratory and warehousing facilities used by or on
behalf of SYNCO in the manufacture, testing, storage, or shipping of product,
product samples or receiving any material or component used in performing the
Services.

        7.3.2 SYNCO will permit CHIRON to conduct preparatory audits
forpre-approval inspections (PAI).

        7.3.3 SYNCO acknowledges that the CHIRON audit team may include
consultants employed by CHIRON to audit on CHIRON behalf. While at the SYNCO
facility, CHIRON personnel will comply with all applicable SYNCO policies,
procedures and regulations.

        7.3.4 The CHIRON Corporate audit to perform at least one standard cGMP
compliance audit per year to encompass all cGMP operations. SYNCO and CHIRON
will work to have reasonable expectations concerning duration and audit team
size.

        7.3.5 SYNCO will permit CHIRON Quality Unit to conduct event reviews, in
addition to annual audits, to address significant product quality, performance
or safety problems. These events

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should be requested, scheduled and conducted at the first available date. Event
reviews may result from but are not limited to the following:

        7.3.5.1 A Warning Letter or other regulatory actions from FDA, EMEA, or
other regulatory agency relating to the manufacture, testing, storage, or
shipment of THE PRODUCTS by SYNCO

        7.3.5.2 Rejection of in-process intermediates or THE PRODUCTS

        7.3.5.3 Repeated product complaints.

        7.3.5.4 Unusual data trends with respect to the manufacturing, testing,
storage, or shipment of product, including, but not limited to a series of batch
failures or stability failures.

        7.4   Audit Closeout

        7.4.1 An exit meeting will be held with representatives from CHIRON and
SYNCO to discuss significant audit observations.

        7.4.2 CHIRON will provide a written report of all observations within
30 days to SYNCO. Within 30 days of the audit report receipt, SYNCO will provide
a written response to all findings that details corrective action to be
implemented. SYNCO will follow up to ensure that all corrective actions are
implemented and provide a report to CHIRON upon implementation Where corrective
action will require extended period to implement regular reports on progress
will be provided to the CHIRON by the SYNCO. Frequency will be mutually agreed
upon.

8.DISPUTE RESOLUTION

        8.1   Licensing or Regulatory Filing Strategy Dispute

        8.1.1 In the event that a dispute arises between CHIRON and SYNCO with
regard to regulatory strategy, the TCM shall in good faith promptly attempt to
reach an agreement.

        8.2   Test Result Dispute

        8.2.1 In the event that a testing result dispute arises between CHIRON
and SYNCO in the testing performed for the product, the resolution will proceed
in stages.

        8.2.1.1 The first stage requires direct communication between QC
Management from both parties to identify the appropriate contacts, who will then
determine that the methods of analysis are the same and are being executed in
the same manner at both sites.

        8.2.1.2 Second, if the investigation dictates, carefully controlled and
split samples should be sent from one site to another in an attempt to reach
agreement.

        8.2.1.3 Should there be a failure to achieve resolution, analysts from
both parties may be required to work side by side through the analysis of a
mutually agreeable sample.

        8.2.1.4 If these actions fail to achieve resolution the issue would go
to the TCM for resolution

        8.3   Product Batch Non-Conformity Dispute

        8.3.1 In the event that a dispute arises between CHIRON and SYNCO in the
non-conformity of a batch of the product, the Quality representatives from both
companies shall in good faith promptly attempt to reach an agreement. If
agreement is not reached, the issue will be taken to the TCM for resolution.

        8.4   Final disposition of product batch and final disposition is the
responsibility of the CHIRON Quality Assurance function as defined in
procedures.

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9.CHANGE MANAGEMENT

        9.1   Procedures for Change Control

        9.1.1 There will be change control procedures at SYNCO that are mutually
agreed upon by both parties.

        9.1.2 All changes go through a technical and cGMP impact assessment.
SYNCO will notify CHIRON in advance of any planned changes by SYNCO possibly
affecting the regulatory submission and/or available supply of the product. This
includes any changes to validated facilities, utilities, computer systems,
equipment or processes.

        9.1.3 SYNCO will have responsibility for providing justification for the
changes and validating any such changes to cGMP standards jointly agreed to.

        9.1.4 Change control procedures will include a requirement for SYNCO to
obtain written approval from CHIRON prior to the implementation of any change
possibly affecting the regulatory submission and/or available supply of the
product.

        9.2   Scope

        9.2.1 The scope of the change management process includes product
manufacturing, testing, storage and shipping processes. The associated changes
may relate to: the master batch records (e.g. master formulas), bill of
materials, analytical standards, test methods (for raw materials and product),
raw material and product specifications; and any changes to validated
facilities, utilities, computer systems, equipment or processes used in the
cleaning, manufacturing, testing, storage or shipment with respect to THE
PRODUCTS.

        9.3   Specification Changes

        9.3.1 If a specification change is required for the in-process
intermediates, or THE PRODUCTS the requesting party will advise the other party
in writing. As appropriate, both parties will cooperate in good faith to
implement the changes to the specification and or impacted activities/processes
as soon as possible, or as required by regulatory authorities. Prior to
implementing a specification change, both parties will give due consideration
and negotiate in good faith in an attempt to reach agreement on any financial or
scheduling impacts of such specification change.

        9.4   Document Distribution

        9.4.1 CHIRON shall be on the distribution list for SYNCO's documents
specific to the product as described above and in section 6 Likewise, SYNCO
shall be on CHIRON's distribution list for appropriate specifications.

10.PRODUCT AND PROCESS VALIDATION

        10.1 Process

        10.1.1 SYNCO is responsible for validating the manufacturing process,
Chiron is responsible for ensuring that the manufacturing process at SYNCO is
validated.

        10.1.2 SYNCO will maintain cGMP validation status of facilities and
process equipments with respect to the manufacturing, storage, shipping and
cleaning procedures that are used in the services provided by SYNCO

        10.1.3 SYNCO will work collaboratively with CHIRON to validate the
product shipping process.

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        10.2 Cleaning Validation

        10.2.1 SYNCO is responsible for ensuring that cleaning processes are
validated for all products produced in the SYNCO facilities and that adequate
cleaning is carried out on components and equipment between batches to prevent
contamination at SYNCO. Chiron is responsible for the validation of the cleaning
processes related to Chiron's products.

        10.2.2 CHIRON and SYNCO will cooperate to establish cleaning limits for
the facilities involved in the manufacture of product.

        10.2.3 The cleaning procedures and analytical methodology will be
jointly reviewed. SYNCO and CHIRON will review cleaning procedures and testing
methodology pertaining to product.

        10.3 Equipment, Computer, Facility, and Utilities Qualification

        10.3.1 SYNCO is responsible for all equipment, computer, facility, and
utility qualification activities associated with the product at SYNCO

        10.3.2 CHIRON has responsibility to review and approve validation master
plans. CHIRON has the right to review protocols and final reports as they relate
to product manufactured for the CHIRON at the SYNCO site and mutually agreed
upon.

        10.3.3 SYNCO will maintain cGMP validation status on the SYNCO Facility,
as well as the utilities, computers and equipment associated with the product
and will make validation reports available to CHIRON for review.

        10.3.4 SYNCO to develop procedures and implementation plans to assure
all critical computer systems and software compliance with FDA requirements.

        10.4 Laboratory Qualification and Validation

        10.4.1 SYNCO is responsible for ensuring that all laboratories are in
compliance with cGMP and are qualified in all of the methodology associated with
the product and facility. SYNCO will maintain cGMP validation status on the
methods used to test the product. SYNCO will provide any existing analytical
documentation to assist in methods transfer or methods validation.

11.CAMPAIGN REVIEW and ANNUAL REPORT

        11.1 Campaign Review

        11.1.1 SYNCO will perform an Campaign Review, Timing to align with the
Annual Report or other regulatory agency requirements. SYNCO will share Campaign
review reports.

        11.1.2 This report will cover all manufacturing, testing, and storage
activities performed by SYNCO. It will contain a review of any changes at SYNCO,
in the manufacturing, testing, storage or validation of the product in the
previous review period and will be formally connected to the change control
system. Additionally it will include major deviations with deviation trending
and a summary of batches made, released, and rejected. Also, control charting or
trend analysis of key product parameters or performance criteria will be
performed as agreed to in advance by the parties. Any abnormalities will be
explained in the campaign Review.

        11.1.3 CHIRON and SYNCO will agree on format and content of the report
and all Parties will make all reasonable efforts to meet to discuss information
in the Campaign Review(s).

10

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        11.2 Annual Report

        11.2.1 CHIRON is responsible for preparing any Annual Report as required
by applicable regulations, including 21 CFR 314.7(g)(3), 314.81(b)(2), and/or
601.12(d), (f)(3).

        11.2.2 CHIRON and SYNCO will agree on format and content of the
information and all Parties will make all reasonable efforts to meet to discuss
information for inclusion in the Annual Report preferably at the same time as
Annual Product Review discussion.

List of Contacts

CHIRON: Lead Quality   SYNCO: Lead Quality Name: Pietro Bagnato   Name: Rob
Sprenkels Title: Head QA, External Manufacturing   Title: Director Quality
Affairs Work:++39 0577 242262   Work: +31 (0)20 7503631 email:
Pietro_Bagnato@chiron.it   Email: Rob_Sprenkels@synco-biopartners.com Fax::+39
0577 2436   Fax: +31 (0)20 7503601
CHIRON: Lead Operations
 
SYNCO: Lead Operations Name: Russell Thirsk   Name: Eust Clemens Title: Head of
External Manufacturing   Title: Director Operations Work:++39 0577 243610  
Work: +31 (0)20 7503675 email: Russell_Thirsk@chiron.it   Email:
Eust_Clemens@synco-biopartners.com Fax::+39 0577 243674   Fax:: +31 (0)20
7503601

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

11

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QuickLinks

Exhibit 10.212

[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS. CONTRACT MANUFACTURING AGREEMENT
APPENDIX A COST OF CERTAIN PRODUCT
APPENDIX B LIST OF PRODUCTS
APPENDIX C OPERATING PROCEDURES AND SPECIFICATIONS
APPENDIX D FIRM ORDERS
APPENDIX E QUANTITIES FOR THE YEARS [***]
APPENDIX F INTERCOMPANY QUALITY AGREEMENT
List of Contacts
[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.