Exhibit 10.63

EXECUTION COPY DATED 8 JANUARY 2010

Confidential Treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as “***”. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

MANUFACTURING AND DISTRIBUTION AGREEMENT (EUROPE AND ROW)

This Manufacturing and Distribution Agreement (Europe and ROW) (this
“Agreement”) is made and entered into this 8th day of January, 2010 (the
“Effective Date”), by and between Stichting Sanquin Bloedvoorziening (Sanquin
Blood Supply Foundation), a foundation (stichting), incorporated under the laws
of The Netherlands, with its registered seat in Amsterdam, and registered with
the Trade Register of the Dutch Chamber of Commerce under number 41217565
(“Sanquin”), and ViroPharma SPRL, a private limited company organized under the
laws of Belgium (“ViroPharma”) (each of Sanquin and ViroPharma is a “Party” and,
collectively, they are the “Parties”).

WHEREAS, Sanquin manufactures and sells, in certain countries, directly and
through distributors, a C1 esterase inhibitor derived from human blood plasma
under the brand name Cetor (“Cetor” or “Cetor Product”), and has also developed
an improved version, which utilizes additional manufacturing steps including
nanofiltration technologies for enhanced viral removal, and which improved
version shall for the purpose of this Agreement be referred to as “Cetor NF” or
“Cetor NF Product” (it being understood that Cetor NF Product is currently
manufactured and sold under the brand name Cetor as well, and may in the future
be manufactured and sold under any other brand name (other than Cinryze) that
Sanquin or its partners may choose);

WHEREAS, ViroPharma has received from Sanquin the right to reference certain
United States regulatory filings relating to C1 esterase inhibitor derived from
human blood plasma currently indicated for hereditary angioedema, which Sanquin
currently manufactures for sale and distribution in the United States under the
brand name, Cinryze;

WHEREAS, Sanquin and ViroPharma have entered into a letter agreement dated
March 11, 2009 (the “Letter Agreement”), pursuant to which ViroPharma has
obtained orphan drug designation for Cinryze in Europe and is in the process of
seeking to obtain marketing authorization in Europe, after which, the Parties
contemplate, Sanquin will manufacture for ViroPharma, and ViroPharma will
purchase from Sanquin, such product pursuant to this Agreement; and

WHEREAS, additionally, the Parties desire that Sanquin grant to ViroPharma
certain rights, and ViroPharma assume certain obligations, relating to the
further research, development, and commercialization of C1 esterase inhibitor
derived from human blood plasma, and that Sanquin undertake to provide to
ViroPharma, and ViroPharma purchase from Sanquin, related clinical and
commercial supplies, all in accordance with the terms and provisions of this
Agreement.

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NOW THEREFORE, in consideration of the mutual promises and covenants contained
herein and other valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, and intending to be legally bound hereby, the parties agree
as follows:

ARTICLE 1

DEFINITIONS AND RULES OF CONSTRUCTION

1.1 Definitions. For the purpose of this Agreement, the following terms shall
have the following meanings:

1.1.1 “Affiliate” means any entity that, directly or indirectly through one or
more other intermediaries, controls, is controlled by, or is under common
control with a Party, wherein “control” and “controlled” means the possession of
the power to direct the management and policies of the entity whether through
ownership of voting securities, by contract or otherwise.

1.1.2 “Annual Minimum Quantity” has the meaning set forth in Section 5.4.1.

1.1.3 “Applicable Law” means each law, rule, regulation, guideline or other
requirement of a Regulatory Authority, including cGMP and the requirements set
forth in any Regulatory Approval, in effect from time to time, which applies to
the research, development, manufacture, marketing, distribution, and/or sale of
any Product.

1.1.4 “Business Day” means any day (other than a Saturday or Sunday) on which
banks are open for normal banking business in the Netherlands and Belgium.

1.1.5 “CAF-DCF” means Centrale Afdeling voor Fractionering van het Rode Kruis
cvba - Département Central de Fractionnement de la Croix-Rouge scrl.

1.1.6 “Capacity Schedule” has the meaning set forth in Section 7.1.

1.1.7 “Cetor Marketing Authorization” means a Regulatory Approval for the Cetor
Product and the Cetor NF Product, respectively (including, the Regulatory
Approval granted by the Dutch Medicines Evaluation Board (College ter
Beoordeling van Geneesmiddelen) for The Netherlands and any Regulatory Approval
granted by any other Regulatory Authority for any country in Europe and any
Regulatory Approval granted by any other Regulatory Authority for any country in
the Rest of World).

1.1.8 “Cetor NF Product” means a human C1 esterase inhibitor derived from
Plasma, that has been developed by Sanquin as an improvement to the Existing
Cetor Product through the use of additional manufacturing steps including
nanofiltration (and which -for the avoidance of doubt- is currently manufactured
and sold under the brand name Cetor and may in the future be manufactured and
sold under any other brand name (other than Cinryze) that Sanquin or its
partners may choose).

 

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1.1.9 “cGMP” means current Good Manufacturing Practices as defined from time to
time under Applicable Law, including without limitation under the Directive
2003/94/EC.

1.1.10 “Cinryze Marketing Authorization” means a Regulatory Approval for the
ViroPharma Product Cinryze as granted by the EMEA.

1.1.11 “Commercially Reasonable Efforts” means with respect to a Party, the
efforts and resources which would be used by that Party consistent with
prevailing pharmaceutical industry standards for a company of similar size and
scope to such Party with respect to a product or potential product at a similar
stage in its development or product life and of similar market potential taking
into account efficacy, safety, the competitiveness of alternative products in
the market place or under development, the patent and other proprietary position
of the product, the likelihood of obtaining Regulatory Approval, the commercial
value of the product and other relevant factors.

1.1.12 “Competitor” means a manufacturer and/or distributor of a Plasma derived
C1 esterase inhibitor or another Plasma-derived product approved under
Applicable Law for marketing for the same or comparable clinical indications as
the Product and/or the ViroPharma Product.

1.1.13 “Confidential Information” means the terms and conditions of this
Agreement and any information relating to the subject matter of this Agreement,
including but not limited to the Sanquin Technology, provided by the Disclosing
Party to the Receiving Party, provided, however, that Confidential Information
shall not include any such information that the Receiving Party can demonstrate:
(a) was known to the Receiving Party at the time of disclosure by the Disclosing
Party (other than through receipt from the Disclosing Party or its Affiliates),
as can be established by written documentation; or (b) was generally available
to the public or was otherwise part of the public domain at the time of such
disclosure or became generally available to the public or otherwise part of the
public domain after such disclosure other than through any act or omission of
the Receiving Party in breach of this Agreement; or (c) became known to the
Receiving Party after disclosure by the Disclosing Party through a
non-confidential disclosure from a source that was not under an obligation of
confidentiality to the Disclosing Party; or (d) was independently developed by
the Receiving Party where such independent development can be established by
written documentation.

1.1.14 “Disclosing Party” means a Party that discloses its Confidential
Information to the other Party.

1.1.15 “Dutch Overseas Territories” means Aruba, Curaçao, Sint Maarten, Bonaire,
Saba and Sint Eustatius, also known as the Netherlands Antilles.

1.1.16 “EMEA” means the European Medicines Evaluation Agency.

1.1.17 “Europe” means the countries constituting the European Union from time to
time, together with Switzerland and those additional countries constituting the
European Economic Area from time to time (as of the Effective Date, Iceland,
Liechtenstein and Norway); provided, however, that the status of any country
that is, as of the Effective Date, a Sanquin Partnered Country (ROW), shall not
change merely because such country becomes a member of the European Union or the
European Economic Area after the Effective Date

 

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1.1.18 “European Union” or “EU” means the economic, scientific and political
organization of member states of the European Union at any time, and which, as
of the Effective Date, consists of Austria, Belgium, Bulgaria, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, and that
certain portion of Cyprus included in such organization.

1.1.19 “Force Majeure Event” has the meaning set forth in Section 17.3.

1.1.20 “Global Commercialization Plan” has the meaning set forth in Section 3.4.

1.1.21 “Intermediates” means plasma intermediate fractions as manufactured from
Plasma required for the manufacture of ViroPharma Product;

1.1.22 “JSC” means the joint steering committee as described in Section 3.1.1.

1.1.23 “Manufacturing Facilities” means Sanquin’s manufacturing facility having
an address at Plesmanlaan 125, P.O. Box 9190, 1006 AD, Amsterdam, The
Netherlands, and CAF-DCF’s manufacturing facility having an address at avenue de
Tyras 109, B-1120, Brussels, Belgium, and a manufacturing facility of any
subcontractor of Sanquin as approved by ViroPharma.

1.1.24 “Phase I/II Clinical Study” means a study conducted in healthy human
volunteers or with the endpoint of determining initial dose tolerance, safety
and or pharmacokinetic information of a single dose or single ascending dose
regimen.

1.1.25 “Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated association,
joint venture or similar entity or organization.

1.1.26 “Plasma” means the fluid portion of human blood collected either from
whole blood donations or by plasmapheresis and intended as a source material for
further manufacturing.

1.1.27 “Product” means C1 esterase inhibitor derived from Plasma manufactured by
Sanquin (and its Affiliates and/or Sanquin’s subcontractors).

1.1.28 “PV Agreement” has the meaning set forth in Section 4.2.1.

1.1.29 “Quality Agreement” has the meaning set forth in Section 5.9.

 

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1.1.30 “Receiving Party” means a Party that receives Confidential Information
from a Disclosing Party, including, but not limited to, employees, directors and
officers of such Receiving Party.

1.1.31 “Regulatory Approval” means any registration, permit, license,
authorization or approval or any application therefor, filed with or granted by
a Regulatory Authority that is required under Applicable Law for the
distribution, sale and marketing of any Product (including, without limitation,
the ViroPharma Product), provided however, that for the purposes of Sections
4.1.5, 4.1.6 and 10.4.4, the term “Regulatory Approval” does not include any
registration, permit, license, authorization, or approval or any application
therefor, relating to the intravenous use of C1 esterase inhibitor for the
treatment or prevention of hereditary angioedema (HAE) in the United States.

1.1.32 “Regulatory Authority” means any supra-national, federal, national,
regional, state, provincial or local regulatory agency, department, bureau,
commission, council or other government entity, including the US Food and Drug
Administration, the European Commission (including the EMEA), and any other
entity exercising regulatory authority with respect to the manufacture,
marketing and/or sale of any Product (including, without limitation, the
ViroPharma Product).

1.1.33 “Regulatory Documentation” means documentation relating to qualification,
requalification, formulation, safety, efficacy and other data and information
generated in the preparation of any Regulatory Approval for C1 esterase
inhibitor, any regulatory documentation maintained with respect to such
Regulatory Approvals and applications therefor, including adverse event reports
and databases, correspondence and notes of interactions with Regulatory
Authorities, literature safety reports and documents relating to cGMP issues,
animal clinical trials, animal research, including without limitation laboratory
and target animal research, and all drug master files contained or referenced
therein or other dossiers or compilations necessary to obtain or maintain such
Regulatory Approvals.

1.1.34 “Sanquin Early Stage Research Program(s)” has the meaning set forth in
Section 3.2.1.

1.1.35 “Sanquin Plasma” has the meaning set forth in Section 5.1.2.

1.1.36 “Sanquin Technology” means information, trade secrets, materials,
know-how, inventions, and data (including process techniques, standard operating
procedures, methods, reports, protocols, clinical and safety data), that relates
to any ViroPharma Product or is useful for the development, manufacture, use,
marketing, sale, or other exploitation of any ViroPharma Product, including any
and all claims of patents and patent applications that claim a ViroPharma
Product or the manufacture or use thereof that are owned (in whole or in part)
by or licensed to Sanquin, with the right to grant sublicenses and including
(i) Sanquin’s interest in Joint Rights and (ii) any of the foregoing arising
under the Sanquin Early Stage Research Programs.

1.1.37 “Semiannual Period” means each six month period, from January through
June, and from July through December.

 

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1.1.38 “Specifications” means the specifications for the ViroPharma Product as
reflected in the Quality Agreement and any dossier that is subject of a
Regulatory Approval, as applicable.

1.1.39 “Sublicensee” means a Person, other than an Affiliate, that is granted a
sublicense by ViroPharma in accordance with the provisions of Section 2.3.

1.1.40 “Subcutaneous Injection” means a method of administering the Product by
injecting the Product, formulated for such use, into the layer between the skin
and the muscle.

1.1.41 “Target Countries” means those specific countries or groups of countries,
identified from time to time in the Global Commercialization Plan, in which
ViroPharma will be using its Commercially Reasonable Efforts to seek Regulatory
Approval for the ViroPharma Products, in accordance with the timeframes and any
other conditions set forth in the Global Commercialization Plan.

1.1.42 “Third Party” means any Person who or which is neither a Party nor, with
respect to a Party, an Affiliate of that Party.

1.1.43 “Unit” means a unit of activity for C1 esterase inhibitor as described in
the dossier that is subject of a Regulatory Approval, as applicable;

1.1.44 “Valid Delaying Event” has the meaning set forth in Section 2.7.1;

1.1.45 “Vial” means a glass container with approximately five-hundred
(500) Units;

1.1.46 “ViroPharma Plasma” has the meaning set forth in Section 5.1.2.

1.1.47 “ViroPharma Portion” has the meaning set forth in Section 7.1.

1.1.48 “ViroPharma Product” means each and any Product for human use other than
Cetor and Cetor NF, including any improvement to such Product upon execution by
ViroPharma of its first right of refusal as referred to in Section 3.2.4 and/or
any improvement to such Product as agreed by the Parties.

1.2 Rules of Construction. For the purpose of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise requires:
(a) defined terms include the plural as well as the singular and the use of any
gender shall be deemed to include the other gender; (b) references to
“Articles”, “Sections” and other subdivisions and to “Appendix(ices)” without
reference to a document, are to designated articles, sections and other
subdivisions of and to appendices to this Agreement; (c) the use of the term
“including” means “including but not limited to”; and (d) the words “herein,”
“hereof,” “hereunder,” and other words of similar import refer to this Agreement
in whole and not to any particular provision. All prices and fees are in euros.

 

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ARTICLE 2

PRODUCT DEVELOPMENT AND TERRITORY RIGHTS

2.1 Certain Territories.

2.1.1 There are certain countries, namely, Belgium, Finland, Luxemburg, and The
Netherlands (including the Dutch Overseas Territories), in which Sanquin has
historically operated (each, a “Sanquin Precedent Country,” and, collectively,
the “Sanquin Precedent Countries”).

2.1.2 There are certain countries in Europe, namely France, Ireland, and the
United Kingdom, in which Sanquin currently has agreements in place with Third
Parties (each, an “Existing Europe Distributor,” and, collectively, the
“Existing Europe Distributors”) for the distribution of Cetor Product and/or
Cetor NF Product manufactured by Sanquin (each, a “Sanquin Partnered Country
(Europe),” and, collectively, the “Sanquin Partnered Countries (Europe)”).

2.1.3 There are certain countries outside of Europe, namely, Egypt, Iran, Israel
(including the Palestinian Authority), Indonesia and Turkey, and the countries
of North, Central, and South America (for the avoidance of doubt: excluding the
Dutch Overseas Territories) in which Sanquin currently has agreements in place
with Third Parties and an Affiliate of ViroPharma (each, an “Existing ROW
Distributor,” and, collectively, the “Existing ROW Distributors”) for the
distribution of Cinryze and Cetor product and/or Cetor NF Product, respectively,
manufactured by Sanquin (each, a “Sanquin Partnered Country (ROW),” and,
collectively, the “Sanquin Partnered Countries (ROW)”); provided, however, that
each of the following countries: (i) all countries in North, Central and South
America, excluding the Dutch Overseas Territories, Argentina and Brazil, and
(ii) Israel (including the Palestinian Authority)) is only a Sanquin Partnered
Country (ROW) to the extent of the ViroPharma Product as it exists on the
Effective Date; with respect to any improvement of the ViroPharma Product after
the Effective Date upon execution by ViroPharma of its first right of refusal as
referred to in Section 3.2.4 and/or any improvement to such Product as agreed by
the Parties, such countries are part of the ViroPharma Territory.

2.1.4 “Rest of World” or “ROW” means all countries and territories in the entire
world except Europe.

2.1.5 “Excluded Territory” means the Sanquin Precedent Countries, the Sanquin
Partnered Countries (Europe), and the Sanquin Partnered Countries (ROW).

2.1.6 “Worldwide” means all countries and territories in the world.

2.1.7 “ViroPharma Territory” means Worldwide, except the Excluded Territory.

 

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2.2 Grants to ViroPharma. Subject to the terms and conditions of this Agreement,
Sanquin hereby grants to ViroPharma:

2.2.1 the exclusive (including with regard to Sanquin and its Affiliates
(subject to the rights of Sanquin and its Affiliates as set out in Section 2.4))
right and license under the Sanquin Technology, to research, develop, import,
use, sell and offer for sale each ViroPharma Product in the ViroPharma
Territory, provided that such ViroPharma Product shall be manufactured by
Sanquin (and its Affiliates and/or Sanquin’s subcontractors) as further set out
in Article 5 hereof;

2.2.2 the exclusive (including with regard to Sanquin and its Affiliates
(subject to the rights of Sanquin and its Affiliates as set out in Section 2.4))
right of reference under the Regulatory Documentation, to support Regulatory
Approvals for the ViroPharma Product in the ViroPharma Territory, including the
Cinryze Marketing Authorization; and

2.2.3 until ViroPharma has obtained Cinryze Marketing Authorization for Europe,
the exclusive (including with regard to Sanquin and its Affiliates (subject to
the rights of Sanquin and its Affiliates as set out in Section 2.4)) right and
license, under the Sanquin Technology, to sell and offer for sale Cetor NF
Product in ***, provided that such Cetor NF Product shall be manufactured by
Sanquin (and its Affiliates and/or Sanquin’s subcontractors), and subject to
ViroPharma giving notification to Sanquin of its intention to sell and offer for
sale Cetor NF Product in such countries in a timely manner and Sanquin
subsequently obtaining Cetor Marketing Authorization for such countries, it
being understood that Sanquin shall use Commercially Reasonable Efforts to
obtain Cetor Marketing Authorization for such countries.

2.3 Sublicenses.

2.3.1 The rights and licenses granted to ViroPharma under Section 2.2 shall
include the right to grant sublicenses (or further rights of reference),
provided that (i) any sublicense of all or substantially all of the rights
licensed to ViroPharma hereunder to a Third Party shall require the prior
written approval of Sanquin which may be granted or withheld in Sanquin’s sole
discretion, and (ii) any sublicense of all or substantially all of the rights
licensed to ViroPharma hereunder to a Third Party for a particular country or
countries within the ViroPharma Territory shall require the prior written
approval of Sanquin, such approval not to be unreasonably withheld. If Sanquin
does not respond to ViroPharma’s request for Sanquin’s consent of any such
sublicense contemplated by Section 2.3.1(ii) to a Third Party within ***
Business Days after the date of receipt of ViroPharma’s request, then such
consent shall be deemed given by Sanquin. ViroPharma’s obligations hereunder
shall not be affected by the sublicense of any or all of its rights hereunder.
ViroPharma shall provide to Sanquin a written notice setting forth in reasonable
detail the nature of such sublicense and the identity of the Sublicensee.
Immediately upon entering into a sublicense agreement (with the prior written
approval of Sanquin), ViroPharma shall provide to Sanquin a copy of such
executed sublicense agreement. Any material amendment to such agreement shall
require the prior written approval of Sanquin, it being understood that with
respect to a sublicense agreement contemplated by Section 2.3.1(ii) above,
Sanquin’s approval of any amendment thereof shall be deemed given if Sanquin
does not respond to ViroPharma’s request for Sanquin’s approval of such
amendment within *** Business Days after the date of

 

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receipt of ViroPharma’s request. ViroPharma guarantees the performance of its
permitted Sublicensees and the grant of any such sublicenses shall not relieve
ViroPharma of its obligations under this Agreement. Any such sublicense
agreements shall be consistent with and subject to the terms and conditions of
this Agreement.

2.3.2 Notwithstanding any provision to the contrary in this Agreement, if
ViroPharma desires to utilize one or more Third Parties to perform certain tasks
pursuant to ViroPharma’s clinical research program, ViroPharma, may, as part of
such contract, grant to such Third Party a nonexclusive, nontransferable,
nonsublicensable license or sublicense, as applicable, only to the extent and
only for so long as such license or sublicense is necessary for such Third Party
to perform such tasks under ViroPharma’s clinical research program and subject
to the discussion of the granting of such (sub)license by the Parties within the
scope of the JSC. ViroPharma guarantees the performance of any such sublicensees
and the grant of any such sublicenses shall not relieve ViroPharma of its
obligations under this Agreement.

2.4 No Implied Rights; Reservation of Rights. ViroPharma, its Sublicensees and
its Affiliates shall have no right to manufacture the ViroPharma Product.
ViroPharma, its Sublicensees and its Affiliates shall have no right, express or
implied, with respect to the Sanquin Technology except as expressly provided in
this Agreement. Sanquin reserves the right under the Sanquin Technology to
(a) perform its obligations under this Agreement; (b) conduct the Sanquin Early
Stage Research Programs; and (c) subject to ViroPharma’s rights under
Section 2.6.1, obtain and maintain Regulatory Approvals for, and develop and
commercialize and otherwise exploit, in accordance with the terms of this
Agreement, (i) Products outside the ViroPharma Territory and (ii) other products
for any purpose. Sanquin and its Affiliates shall have no right, expressed or
implied, to any assets or properties of ViroPharma and/or ViroPharma’s
Affiliates, except as explicitly set forth in this Agreement. Without limiting
the generality for the previous sentence, and for the avoidance of
doubt, nothing in this Agreement, including the provisions of Sections 4.1.5,
4.1.6 and 10.4.4, gives Sanquin any right to acquire any registration, permit,
license, authorization, or approval, or any application therefor, relating to
the intravenous use of C1 esterase inhibitor for the treatment or prevention of
hereditary angioedema (HAE) in the United States.

2.5 Denial of Cinryze Marketing Authorization. In the event the EMEA does not
grant the Cinryze Marketing Authorization for Europe and ViroPharma ***, or in
the event the EMEA does not grant the Cinryze Marketing Authorization for Europe
***, Sanquin will grant to ViroPharma (a) an exclusive license under the Sanquin
Technology to import, market, distribute and sell Cetor NF Product in the
ViroPharma Territory that is part of Europe, provided that the Cetor NF Product
shall be manufactured by Sanquin and its Affiliates and/or Sanquin’s
subcontractors, and (b) an exclusive right to reference the Cetor Marketing
Authorization to support Regulatory Approvals in such part of the ViroPharma
Territory, on conditions to be agreed upon between the Parties.

2.6 Right of First Refusal.

2.6.1 Right of First Refusal to Expanded Territory. In the event of termination
of any of the agreements in place with the Existing Europe Distributors and the
Existing

 

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ROW Distributors, ViroPharma shall have a right of first refusal to obtain the
exclusive rights and licenses as referred to in Sections 2.2.1 and 2.2.2,
respectively, with the right to grant sublicenses in accordance with
Section 2.3, in any of the Sanquin Partnered Countries (Europe) and the Sanquin
Partnered Countries (ROW) (as applicable). Sanquin shall give ViroPharma written
notice of the termination of any of the agreements in place with the Existing
Europe Distributors or the Existing ROW Distributors, and ViroPharma shall have
*** days after receipt of such notice to exercise its right of first refusal by
giving written notice to Sanquin of its intention to acquire such expanded
territory. If ViroPharma informs Sanquin that it wishes to exercise its right of
first refusal, the Parties shall agree on the conditions that shall be
applicable to ViroPharma’s rights in such expanded territory. If the Parties
reach agreement on such conditions, the ViroPharma Territory shall be expanded
to include the additional territory. If the Parties cannot reach agreement on
such conditions, Sanquin will be free to contract with a Third Party, provided
that Sanquin shall not contract with a Third Party under conditions less
favourable to Sanquin than those proposed by ViroPharma. Also in the event that
ViroPharma informs Sanquin in writing that it will not exercise its right of
first refusal, or if ViroPharma does not send any notification to Sanquin within
the aforementioned ***-days-period, Sanquin will be free to contract with a
Third Party.

2.7 Additional Rights For Sanquin.

2.7.1 In the event that ViroPharma shall not have used its Commercially
Reasonable Efforts to file an application for Regulatory Approval for a
ViroPharma Product in any Target Country in accordance with the timeframes set
forth in the Global Commercialization Plan, or in the event that ViroPharma
shall not have used its Commercially Reasonable Efforts to commercially launch a
ViroPharma Product in any Target Country in accordance with the timeframes set
forth in the Global Commercialization Plan (except in both cases as a result of
(a) a Force Majeure Event, or (b) ViroPharma’s good faith reasonable
determination regarding the advisability, from a regulatory or commercial
perspective, of proceeding as originally planned in the Global Commercialization
Plan, including as a result of Sanquin’s failure or inability to supply
ViroPharma Product or withholding of consent or any other action or omission of
Sanquin that affects the timing or feasibility of any of the events described in
the Global Commercialization Plan, and, in all cases discussed and approved by
the Parties within the scope of the JSC (each, a “Valid Delaying Event”)), upon
delivery of written notice by Sanquin, if ViroPharma has not taken corrective
action within *** days of the date of such notice (such action to be
demonstrated by ViroPharma), Sanquin may decide that ViroPharma’s rights as set
out in Section 2.2 shall lapse with respect to such affected portion of the
ViroPharma Territory, which decision shall be confirmed in writing by Sanquin to
ViroPharma.

2.7.2 In the event that Sanquin receives a bona fide written offer from a ready,
willing and able prospective Third Party that has access to Plasma in a certain
country that is in the ViroPharma Territory, to toll manufacture out of such
Plasma a Product, to be marketed and sold in such country, and ViroPharma does
not, at the time, distribute or have a plan to distribute ViroPharma Products in
such country, then Sanquin shall be permitted to negotiate such offer; provided
that it gives notice to ViroPharma, includes

 

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ViroPharma in the negotiations as far as the Product is concerned, and enters
into an agreement with ViroPharma and the Third Party, on terms acceptable to
all parties involved.

ARTICLE 3

JOINT STEERING COMMITTEE; DEVELOPMENT ISSUES

3.1 Joint Steering Committee.

3.1.1 Within thirty (30) days after the Effective Date, the Parties shall form a
joint steering committee (“JSC”) consisting of an equal number of
representatives of each Party. The Parties agree that the JSC shall be a
consultation body. Within the scope of the JSC (or any subcommittee thereof as
may be established by the Parties), the Parties shall:

(a) approve of (amendments, modifications or updates to) the Global
Commercialization Plan;

(b) report progress and communicate the status of each Party’s performance of
its obligations under this Agreement, including the implementation of the Global
Commercialization Plan;

(c) report the progress of and any findings from the Sanquin Early Stage
Research Programs;

(d) establish and periodically update the Capacity Schedule;

(e) agree on the terms of the PV Agreement;

(f) agree on the terms of the Quality Agreement;

(g) establish a structured improvement program relating to the manufacturing of
the ViroPharma Product, including: developing *** if and to the extent possible,
it being understood that any *** relating to a modification of the ***, if any,
will be exclusively for the benefit of Sanquin;

(h) confer regarding additional related matters at the request of either Party;

(i) discuss matters including but not limited to (i) pre-clinical and clinical
development strategy; (ii) analysis and assessment of ongoing pre-clinical and
clinical development of ViroPharma Product or Product; (iii) regulatory and
quality assurance matters; and (iv) manufacturing. In addition, the operation of
the JSC shall be as follows:

3.1.2 ViroPharma and Sanquin shall each appoint *** representatives as their
representatives to serve on the JSC, it being understood that the Parties may at
any time

 

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agree to change such number of representatives to be appointed by each Party.
The representatives of a Party may be changed from time to time at the
discretion of that Party upon written notification by the Party making such
change to the other. The Parties shall take turns appointing one of their
representatives to serve as chairperson of the JSC for a *** year term.

3.1.3 The JSC shall meet from time to time as determined by the JSC members. It
is expected that the JSC shall meet in person at least once in each calendar
quarter, at a location to be agreed by the Parties. Minutes of all meetings will
be prepared and circulated by the Party hosting the meeting within *** days of
such meeting. A meeting may be held by means of telephone conference or similar
communications equipment by means of which all persons participating in the
meeting can hear each other.

3.2 Sanquin’s Development Program.

3.2.1 The Parties acknowledge that Sanquin has conducted, currently conducts,
and will, in the future, conduct in vitro and animal studies research programs
and Phase I/II Clinical Studies relating to (i) the Product, including
concerning (a) possible improvements to the Product, (b) portions of the
Product, including any fragment, peptide mimetic or other composition of matter
that is derived from C1 esterase inhibitor or information relating thereto
(including its sequence, structure or activity), (c) discovery, device or
formulation related to C1 esterase inhibitor or use thereof, and (d), in all of
the foregoing cases, whether or not patented or patentable, including any
enhancement in the operation, ingredients, presentation, formulation (including
Subcutaneous Injection), means of delivery or dosage, any discovery or
development of any new or expanded indications or applications for C1 esterase
inhibitor, or any discovery or development that improves the stability, safety
or efficacy thereof), and (ii) “recombinant” C1 esterase inhibitor (like)
product, by itself and also together with Affiliates and/or Third Parties,
including, but not limited to, academic research institutions (“Sanquin’s
Research Partners”), all such research programs and clinical studies
collectively referred to as the “Sanquin Early Stage Research Programs” (and,
each individually, a “Sanquin Early Stage Research Program”), and all current
Sanquin Early Stage Research Programs as listed in Appendix 3, attached hereto
and to be updated by Sanquin from time to time by providing notice to
ViroPharma.

3.2.2 Sanquin shall enter into a written agreement with each of Sanquin’s
Research Partners for the purposes of (a) requiring each subject Sanquin’s
Research Partner to maintain the confidentiality of all confidential information
disclosed in connection therewith other than publications with Sanquin as
permitted by Section 3.2.10; (b) requiring each subject Sanquin’s Research
Partner to assign and to agree to assign any and all intellectual property
rights and data created under any Sanquin Early Stage Research Program to
Sanquin or to Sanquin’s designee (to the extent permitted under Applicable Law);
(c) agreeing to the restrictions set forth in Section 3.2.7 below; and
(d) requiring each of Sanquin’s Research Partners to otherwise comply with the
terms of this Section 3.2 to the extent applicable. Each such written agreement
shall confirm that ViroPharma is an intended third party

 

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beneficiary thereof, and ViroPharma shall have the right to receive a copy of
each such agreement upon request. It is understood that the aforementioned
obligation to enter into written agreements with Sanquin’s Research Partners
relates to Sanquin’s future Research Partners. With respect to Sanquin’s
existing Research Partners at the Effective Date, Sanquin shall use best efforts
to enter into such agreements.

3.2.3 During a five-year-period after the Effective Date; i.e. until 31 December
2014, ViroPharma shall support the Sanquin Early Stage Research Programs by way
of payment of an amount of €1,000,000 (one million euros) per annum, to be paid
in *** installments, and to be paid in full on or before the *** day of the ***
to which they relate. The aforementioned amount shall be adjusted annually on
January 1, starting on ***, on the basis of the adjustment of the *** according
to the following formula: ***. In the beginning of *** the Parties shall
evaluate the support of the Sanquin Early Stage Research Programs by ViroPharma
and no later than 1 July *** the Parties shall decide whether or not ViroPharma
shall continue such support as of 1 January *** for a subsequent period and
amount to be agreed upon between the Parties.

3.2.4 In return (as long as ViroPharma supports the Sanquin Early Stage Research
Programs) ViroPharma shall have a first right of refusal (as further set out
below) to further develop and subsequently commercialize the subject matter of
each Sanquin Early Stage Research Program in the ViroPharma Territory, provided
(for the avoidance of doubt) that any resulting ViroPharma Product shall be
manufactured by Sanquin (and its Affiliates and/or Sanquin’s subcontractors)
upon commercially reasonable terms to be agreed upon between the Parties.

3.2.5 Sanquin shall regularly report to the JSC in respect of the progress of
and any findings from the Sanquin Early Stage Research Programs.

3.2.6 ViroPharma may agree to become primarily responsible for any Sanquin Early
Stage Research Program and to further develop the subject matter of any Sanquin
Early Stage Research Program. In such event ViroPharma will prepare projections
and commercialization plans for discussion with Sanquin, with periodic updates
as agreed by the Parties. Furthermore in such event further research may be
contracted out by ViroPharma to Sanquin or carried out elsewhere at ViroPharma’s
discretion. In case of contracting out to Sanquin a specific research and
development program and budget will be agreed upon by the Parties.

3.2.7 If ViroPharma has agreed to become primarily responsible for any Sanquin
Early Stage Research Program, and in the event that the outcome from such
Sanquin Early Stage Research Program is not patentable, ViroPharma shall have
exclusive rights to all data, information, materials and inventions and
intellectual property rights in relation to and/or resulting from such Sanquin
Early Stage Research Program, provided however, that Sanquin and Sanquin’s
Research Partners shall have the non-exclusive, non-transferable right to
practice or use any new invention or data for Sanquin’s own internal,
non-commercial research purposes free of any obligation to compensate
ViroPharma, and shall provide periodic updates of all such activities to
ViroPharma.

 

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3.2.8 If ViroPharma has agreed to become primarily responsible for any Sanquin
Early Stage Research Program, and in the event that the outcome from any Sanquin
Early Stage Research Program is patentable, Sanquin shall submit a complete
description of such patentable discovery to ViroPharma (a “Patentable Discovery
Notice”). ViroPharma shall have *** days to evaluate such Patentable Discovery
Notice and in the event ViroPharma provides written notice electing to pursue
such Patentable Discovery Notice within such ***-days-period, then ViroPharma
and Sanquin shall collaborate to prepare, file and prosecute the discovery
described in the Patentable Discovery Notice. ViroPharma shall be the party who
files such patent provided however that Sanquin shall be provided an opportunity
to review the text of the application before filing and ViroPharma shall consult
with Sanquin with respect thereto and shall provide Sanquin with copies of such
filing and the status of the filing as well as copies of all correspondence
related to the filing, prosecution and maintenance of such filing. ViroPharma
shall pay *** incurred in preparing, filing, prosecuting and maintaining such
patents. In addition, ViroPharma shall provide Sanquin with a one-time payment
of €*** euros) upon the filing of any such patent. ViroPharma hereby grants, and
shall grant, to Sanquin and Sanquin’s Research Partners, a non-exclusive,
non-transferable right to practice or use any new invention or data for
Sanquin’s own internal, non-commercial research purposes free of any obligation
to compensate ViroPharma (without prejudice to Section 3.2.14). In the event
ViroPharma does not provide Sanquin with a notice electing to pursue a
Patentable Discovery Notice within *** days, then Sanquin shall be free to file
a patent (and shall solely bear all costs related to the filing, prosecution and
maintenance of a patent) and shall solely own all data, information, materials,
inventions and any and all intellectual property rights covered by such patent.

3.2.9 In the event that Sanquin identifies a certain finding from the Sanquin
Early Stage Research Programs as an interesting lead for further development,
and if ViroPharma has not confirmed to Sanquin in writing within a period of ***
months upon presentation of such finding by Sanquin to the JSC its decision to
pursue such finding, the Parties shall confirm this in writing and Sanquin shall
have the right to enter into an agreement with a Third Party to seek
commercialization of such product lead with such Third Party. For the avoidance
of doubt: in such event ViroPharma shall have no rights (including any
intellectual property rights) with respect to such product lead.

3.2.10 At any point in time when Sanquin is of the opinion to have gathered
sufficient scientific data from any Sanquin Early Stage Research Program, even
if ViroPharma has agreed to become primarily responsible for any Sanquin Early
Stage Research Program pursuant to execution of its first right of refusal as
referred to in Section 3.2.4 above, Sanquin’s research staff may publish results
from such Sanquin Early Stage Research Program (a “Public Disclosure”), provided
that the Parties have agreed that there are no results, discoveries, or
inventions that should be patent-protected first or that either Party would seek
to maintain as a trade secret. Sanquin shall provide a

 

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draft manuscript of any Public Disclosure to ViroPharma not less than *** days
before a presentation or submission for publication to enable ViroPharma to
review and comment upon such Public Disclosure. Upon notification by ViroPharma
that the draft manuscript contains information for which ViroPharma desires to
seek patent protection, Sanquin shall remove such information prior to such
Public Disclosure. If ViroPharma does not respond to Sanquin within such *** day
period, then Sanquin shall be free to publish the Public Disclosure exactly as
presented to ViroPharma.

3.2.11 ViroPharma is considering the development of a “recombinant” (non-plasma
derived) C1 esterase inhibitor to be commercialized by ViroPharma. In case of
contracting out of such development to Sanquin a specific research and
development program and budget will be agreed upon by the Parties.

3.2.12 Without prejudice to Section 12.1, in the event of commercialization of a
“recombinant” (non-plasma derived) C1 esterase inhibitor by ViroPharma or any of
its Affiliates, including any Third Party directly or indirectly taking over
ViroPharma in the future, Sanquin shall be entitled to compensation in the form
of milestone payments or royalties. The Parties agree that they shall negotiate
in good faith the amount of such compensation to be paid to Sanquin, taking into
account among other things that such “recombinant” C1 esterase inhibitor will
compete with the Product and the ViroPharma Product and that it may not or only
to limited extent be manufactured by Sanquin, while it can only be successfully
launched thanks to the Sanquin Technology and the commercialization of the
Product and the ViroPharma Product. For the avoidance of doubt, any such
recombinant product is not a “Product” or a “ViroPharma Product” under this
Agreement unless and until the Parties agree otherwise.

3.2.13 Sanquin shall have the right to seek to include in its regulatory
dossiers any improvements to the ViroPharma Product, including but not limited
to new indications, applications or formulations, including Subcutaneous
Injection, but (a) only for the HAE indication; and (b) only for marketing and
sales of Cetor/Cetor NF in the Sanquin Precedent Countries and the Sanquin
Partnered Countries (Europe) and the Sanquin Partnered Countries (ROW).

3.2.14 In case of new indications licensed to ViroPharma relating to Cinryze or
any ViroPharma Product other than the HAE-indication or any improvements
relating to the HAE-indication that can not be included in Sanquin’s Cetor/Cetor
NF dossiers as set forth in Section 3.2.13, Sanquin and/or any of its Affiliates
will receive a *** license (including a license to use any intellectual property
rights developed and owned by ViroPharma hereunder, to the extent necessary to
distribute such ViroPharma Product for such new indications or improvements to
the HAE-indication) for these new indications or improvements to the
HAE-indication in the Sanquin Precedent Countries.

3.3 ViroPharma’s Development Program. In addition to ViroPharma’s rights set
forth in Section 3.2.4, the Parties will from time to time, discuss the status
of ViroPharma’s development efforts relating to any ViroPharma Product,
including Sanquin’s accommodation of and participation in such efforts in
accordance with the provisions of Article 4 and Article 5. In the event that the
Parties believe that more significant development efforts are required by

 

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Sanquin, the Parties may enter into good faith negotiations regarding a specific
research and development program and budget, pursuant to which, upon the Parties
mutual agreement, Sanquin would support ViroPharma’s exercise of its rights to
develop the applicable ViroPharma Product.

3.4 Global Development of ViroPharma Products. Pursuant to and subject to the
terms of this Agreement, ViroPharma shall use its Commercially Reasonable
Efforts to develop and commercialize ViroPharma Products in the ViroPharma
Territory, with the goal of obtaining Regulatory Approval and commercial sales
of ViroPharma Products in the Target Countries. Within *** days of the Effective
Date, the Parties agree to jointly submit to the JSC for approval by the Parties
a Global Commercialization Plan (the “Global Commercialization Plan”) that
identifies Target Countries and describes the development and obtaining of
Regulatory Approval of ViroPharma Products in Target Countries. Either Party
may, from time to time, submit amendments, modifications or updates to the
Global Commercialization Plan to the JSC for approval by the Parties. ViroPharma
agrees to use its Commercially Reasonable Efforts to conduct its development
work consistent with the Global Commercialization Plan. Each Party shall
cooperate with and provide reasonable support to the other Party in such Party’s
conduct of development as provided in the Global Commercialization Plan.

ARTICLE 4

REGULATORY MATTERS

4.1 Obligations relating to ViroPharma Product.

4.1.1 Filing and Maintenance of Regulatory Approval.

(a) Subject to and in accordance with the Global Commercialization Plan,
ViroPharma shall use Commercially Reasonable Efforts to obtain Regulatory
Approvals for the ViroPharma Product, including the Cinryze Marketing
Authorization, and undertake all related regulatory activities in connection
therewith, including but not limited to conducting clinical studies as well as
filing of and following-up on applications for such Regulatory Approvals with
the relevant Regulatory Authorities, at ViroPharma’s ***. Also after any
Regulatory Approval for the ViroPharma Product has been obtained, ViroPharma
shall be responsible for all regulatory activities with respect to such
Regulatory Approval, at ViroPharma’s ***.

(b) ViroPharma shall be solely responsible for conducting and supporting all
clinical trials and other development activities in support of its efforts
described in Section 4.1.1(a) and the Global Commercialization Plan. ViroPharma
shall periodically provide Sanquin with the opportunity to review, to make
recommendations concerning and to approve of such clinical trials and other
development activities in advance of conducting such clinical trials within the
scope of the JSC. More specifically ViroPharma shall present to and discuss with
Sanquin a request for approval of any clinical trial it intends to conduct
together with a general outline of such clinical trial, including details in
respect of

 

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the disease entity, the sites (especially if the sites are in the Sanquin
Precedent Countries, the Sanquin Partnered Countries (Europe) or the Sanquin
Partnered Countries (ROW)), the dosing scheme and the clinical endpoint.
Subsequently Sanquin shall have *** Business Days to consider such clinical
trial and to respond to ViroPharma’s request for approval thereof, it being
understood that Sanquin shall take into account any recommendations and/or
requirements with respect to such clinical trial made by the EMEA, FDA or any
other Regulatory Authority. If Sanquin does not respond to ViroPharma’s request
for approval of such clinical trial within such ***-Business Day-period, such
approval shall be deemed given by Sanquin. Any disapproval by Sanquin of a
clinical trial shall be duly substantiated, it being understood that the only
basis for disapproval can be ***. In the event of a major change to a general
outline of a clinical trial as approved by Sanquin, ViroPharma will notify
Sanquin thereof, in which event Sanquin will have another ***-Business
Day-period to consider and approve such major change in accordance with what is
set out before.

4.1.2 Ownership of Regulatory Approvals. ViroPharma shall own and grants no
rights to Sanquin in and to the, Regulatory Approvals for the ViroPharma
Product. Sanquin shall establish and maintain such Regulatory Documentation
necessary to support the exercise of ViroPharma’s rights, and the exercise of
ViroPharma’s obligations, under this Agreement.

4.1.3 Information obligations relating to Regulatory Approvals. ViroPharma shall
inform Sanquin on a *** basis of the status of all applications for Regulatory
Approvals for the ViroPharma Product as filed by ViroPharma. In addition
ViroPharma shall provide to Sanquin copies of all registration dossiers relating
to the ViroPharma Product (including any updates of such dossiers) that are the
subject of Regulatory Approvals.

4.1.4 ViroPharma and Sanquin shall disclose to each other all data resulting
from clinical studies as well as any other data of which either of them may come
into possession related to the Product or the ViroPharma Product. ViroPharma and
Sanquin agree to consult with each other in the interpretation and reporting of
such data. ViroPharma and Sanquin shall have the right to use such data *** in
reporting and updating their regulatory files in support of obtaining and
maintaining regulatory approvals.

4.1.5 Commercialization. ViroPharma shall use its Commercially Reasonable
Efforts to, after receipt of Regulatory Approval for a ViroPharma Product in a
Target Country, launch such ViroPharma Product for commercial sale in such
Target Country in accordance with the timeframes set forth in the Global
Commercialization Plan. ViroPharma shall promptly deliver notice to the JSC of
its decision to cease the commercialization of, or to not commercialize, a
ViroPharma Product in any country of the ViroPharma Territory where ViroPharma
holds a valid Regulatory Approval or has filed an application for Regulatory
Approval including in such notice whether such determination is a result of a
Valid Delaying Event. If such decision is not a result of a Valid Delaying
Event, upon written request of Sanquin, ViroPharma shall have the option

 

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to (i) change its decision and use its Commercially Reasonable Efforts to
commercialize the ViroPharma Product in such Target Country (and shall have ***
days to provide Sanquin with reasonable evidence of such efforts) or
(ii) transfer its rights to such Regulatory Approval with respect to such Target
Country or application for Regulatory Approval with respect to such Target
Country to Sanquin for ***.

4.1.6 ViroPharma shall promptly inform Sanquin of the filing of a petition for
bankruptcy of ViroPharma or any application for any equivalent insolvency
proceedings in respect of ViroPharma. After ViroPharma has become bankrupt or
insolvent upon filing of such petition or application, the following applies: in
the event that ViroPharma is in breach of this Agreement and such breach has not
been cured within *** Business Days after delivery of a written notice of
default, Sanquin shall *** obtain for *** ViroPharma’s rights to the Regulatory
Approvals as obtained by ViroPharma and/or the applications for Regulatory
Approvals as filed by ViroPharma under this Agreement.

4.1.7 Cooperation. Without limiting the generality of the foregoing, the Parties
shall, in compliance with Applicable Law, collaborate and cooperate in the
preparation and filing of all applications for Regulatory Approvals for the
ViroPharma Product, including without limitation in connection with
communications to or inspections or audits by a Regulatory Authority. Without
limiting the generality of the foregoing, in connection with the preparation and
filing of the Cinryze Marketing Authorization, Sanquin shall cooperate with any
reasonable requests for assistance from ViroPharma, including by, at Sanquin’s
***, (a) making its employees, consultants and other staff available upon
reasonable notice during normal business hours to attend meetings with
Regulatory Authorities concerning the ViroPharma Product, and (b) disclosing and
making available to ViroPharma its Regulatory Documentation including without
limitation manufacturing and quality control data and other information on the
manufacturing process for the ViroPharma Product as is reasonably necessary to
prepare, file, obtain and maintain any Regulatory Approval for the ViroPharma
Product.

4.2 Pharmacovigilance.

4.2.1 Each Party shall promptly notify the other Party of any information that
comes to such Party’s attention concerning any serious or unexpected side
effect, injury, toxicity or sensitivity reaction, and the severity thereof, due
to any cause associated with, or observed in conjunction with the use or
following administration of, the ViroPharma Product in accordance with that
certain Pharmacovigilance Agreement to be entered into between the Parties (the
“PV Agreement”). The terms of the PV Agreement shall be discussed and agreed
upon between the Parties within the scope of the JSC. The Parties shall use best
efforts to enter into such PV Agreement no later than ***.

4.2.2 Product Recalls. If a Party should elect, or be required by a Regulatory
Authority with jurisdiction thereof to initiate a recall, withdrawal, stock
recovery or field correction with respect to a batch of ViroPharma Product
(each, or collectively, a “Recall”) due to a defect in such batch of ViroPharma
Product, or for any other reason whatsoever, in each case, that would be
reasonably likely to impact the marketing or sale of ViroPharma Product, such
Party shall immediately notify the other Party thereof.

 

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Sanquin shall have the sole right and responsibility, to initiate all Recall
procedures required or requested by any Regulatory Authority in the Sanquin
Precedent Countries, or to have conducted on its behalf by a Third Party as
determined appropriate by it in its sole discretion, and ViroPharma shall have
the sole right and responsibility, to initiate all Recall procedures required or
requested by any Regulatory Authority in the ViroPharma Territory, or to have
conducted on its behalf by a Third Party as determined appropriate by it in its
sole discretion, provided, however, that Sanquin shall not initiate any
voluntary Recall without the prior written consent of ViroPharma and that
ViroPharma shall not initiate any Recall without the prior written consent or
upon instruction of Sanquin. ViroPharma shall be liable for any and all costs
made in relation to a Recall (including costs made by Sanquin). However, Sanquin
shall be liable for such costs if a Recall is the result of Sanquin’s
manufacturing error or omission, or the negligence of Sanquin.

4.2.3 Retention of Samples and Documentation.

(a) Generation and Retention Sanquin. Sanquin shall generate, retain and
maintain (a) all records necessary to comply with cGMP and all other Applicable
Law relating to the manufacture of the ViroPharma Product; (b) all manufacturing
records, standard operating procedures, equipment log books, batch manufacturing
records, laboratory notebooks and all raw data relating to the manufacturing of
the ViroPharma Product; and (c) samples of each batch and raw materials
(including without limitation the Sanquin Plasma).

(b) Generation and Retention ViroPharma. ViroPharma shall generate, retain and
maintain: (a) all records necessary to comply with good distribution practices
and all other Applicable Law relating to the storage, distribution and sale of
the ViroPharma Product; and (b) all records, standard operating procedures,
equipment log books, suppliers data and other raw data relating to the purchase,
storage and shipment of the ViroPharma Plasma and samples of ViroPharma Plasma.

For purposes of this Section 4.2.3, samples shall include a quantity of
representative material of each batch and raw materials sufficient to perform at
least full duplicate quality control testing, and shall specify the dates of
manufacture and packaging thereof. Samples so retained shall be selected at
random from either final container material or from bulk and final containers;
provided that they include at least one final container as a final package, or
package-equivalent of such filling of each batch. Such sample shall be stored at
temperatures and under conditions which will maintain the identity and integrity
of the relevant sample.

(c) Retention Period. All materials, samples, records and other items referred
to in this Section 4.2.3 shall be retained by Sanquin and ViroPharma,
respectively, for such period as may be required by cGMP, good distribution
practices and all other Applicable Law.

 

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ARTICLE 5

MANUFACTURING AND SUPPLY OF PRODUCT

5.1 Supply of ViroPharma Product to ViroPharma.

5.1.1 As per the date on which ViroPharma commences marketing a ViroPharma
Product in any part of the ViroPharma Territory following its receipt of
Regulatory Approval in such territory and in accordance with the forecasting and
ordering mechanism as agreed upon between the Parties, Sanquin shall supply to
ViroPharma such ViroPharma Product as ordered by ViroPharma in accordance with
Section 5.3.

5.1.2 Sanquin, as the owner of the Sanquin Technology, shall be responsible for
manufacturing the ViroPharma Product (whether by itself or its Affiliates
(including CAF-DCF) or any subcontractors). Sanquin shall manufacture the
ViroPharma Product on the basis of surplus fractions from Plasma obtained by
Sanquin, as available from time to time (“Sanquin Plasma”). ViroPharma shall pay
to Sanquin a price for such ViroPharma Product as manufactured on the basis of
Sanquin Plasma as set out in Section 6.1.1 (“Purchase Price”). If and to the
extent that ViroPharma’s demand for ViroPharma Product exceeds the volume of
ViroPharma Product as can be supplied by Sanquin on the basis of Sanquin Plasma,
the ViroPharma Product shall be manufactured by Sanquin for ViroPharma on a
toll-manufacturing basis, using Plasma supplied to Sanquin by ViroPharma
(“ViroPharma Plasma”) ***, for a toll manufacturing fee as set out in
Section 6.1.2 (“Manufacturing Fee”) and as further set out in Section 5.2 below.
Sanquin shall ensure that the Sanquin Plasma and ViroPharma shall ensure that
the ViroPharma Plasma shall be collected in accordance with the procedures set
out in the Quality Agreement.

5.2 Toll manufacturing services.

5.2.1 Supply of ViroPharma Plasma by ViroPharma to Sanquin. ViroPharma shall
supply to Sanquin *** sufficient quantities of ViroPharma Plasma required for
the manufacture of the ViroPharma Product pursuant to this Agreement.

5.2.2 ViroPharma shall supply all such ViroPharma Plasma to Sanquin at CAF-DCF’s
warehouse in Buggenhout, Belgium, at ViroPharma’s ***

5.2.3 Handling of ViroPharma Plasma. Sanquin shall procure that upon receipt of
ViroPharma Plasma at the warehouse in Buggenhout, Belgium, CAF-DCF shall provide
the following services:

(i) take in and store said ViroPharma Plasma, up to a maximum of ***% of the
volume of ViroPharma Plasma required to manufacture such volume of ViroPharma
Product as (anticipated to be) ordered for the next ***-month-period according
to the latest Semiannual Forecast, it being understood that a temporary excess
of such maximum is permitted with the prior approval of Sanquin;

 

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(ii) assemble said ViroPharma Plasma into batches ready for manufacturing; and

(iii) subsequently transport such batches to the relevant manufacturing facility
for the manufacture of the ViroPharma Product,

collectively: (the “Handling Services”), such Handling Services to be carried
out in accordance with the Quality Agreement.

5.2.4 Residuals of ViroPharma Plasma. Subject to any agreements that ViroPharma
or its Affiliates has/have with any Third Parties, Sanquin may purchase from
ViroPharma such components or residuals of ViroPharma Plasma as are, as of the
time of such purchase, in surplus to the needs of ViroPharma (to the sole
discretion of ViroPharma) at such reasonable prices to be agreed upon in writing
between the Parties. Any remaining residuals not purchased by Sanquin will be
stored and maintained by Sanquin in the plasma warehouse of CAF-DCF in
Buggenhout, up to a maximum volume of residuals equal to ***% of the volume of
ViroPharma Plasma required to manufacture such volume of ViroPharma Product as
(anticipated to be) ordered for the next ***-month-period according to the
latest Semiannual Forecast (it being understood that a temporary excess of such
maximum is permitted with the prior approval of Sanquin) and/or otherwise made
available for sale to other parties as ViroPharma shall determine. The Parties
agree to negotiate in good faith on any fees for these additional services.

5.3 Forecasts and Orders

5.3.1 At least *** days prior to the first day of each Semiannual Period during
the Term, ViroPharma shall deliver to Sanquin a written, good faith *** month
forecast of the volume of ViroPharma Product that ViroPharma then anticipates
will be required to be produced and delivered to ViroPharma during that
*** month period (the “Semiannual Forecast”). The first *** months of the
Semiannual Forecast shall contain ViroPharma’s volume requirements for
ViroPharma Product by month (the “Firm Portion”), which shall be binding on the
Parties. The remaining *** months of the Semiannual Forecast shall contain
ViroPharma’s non-binding then-anticipated volume requirements for ViroPharma
Product by calendar *** only.

5.3.2 As part of each Firm Portion, ViroPharma shall place firm orders with
Sanquin, setting forth Units (or any other measurement agreeable to both
Parties), the various countries such Units shall be delivered to, anticipated
delivery dates and shipping instructions with respect to each shipment of
ViroPharma Product for delivery. Actual supply and shipment shall then take
place pursuant to purchase orders which are in a form and according to a working
procedure mutually acceptable to ViroPharma and Sanquin and consistent with the
terms of this Agreement.

5.3.3 Sanquin shall not be obligated to accept any Firm Portion to the extent
the quantity of ViroPharma Product ordered pursuant to such Firm Portion exceeds
***% of the quantity of ViroPharma Product that was anticipated to be ordered
for the same Semiannual Period according to the immediately preceding Semiannual
Forecast.

 

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Notwithstanding the foregoing limitations, Sanquin shall use commercially
reasonable efforts to fill such order for such excess quantities from available
supplies, and Sanquin shall use commercially reasonable efforts to notify
ViroPharma within *** Business Days after receipt of an order of Sanquin’s
ability to fill any amounts of such order in excess of the quantities that
Sanquin is obligated to supply. ViroPharma shall notify Sanquin as soon as
possible of an increase in ViroPharma’s requirements for ViroPharma Product
materially in excess of the limits set forth herein. In any event the quantity
of ViroPharma Product that Sanquin is obligated to supply to ViroPharma under
this Agreement shall in any year not exceed the maximum amount as established
for the ViroPharma Portion in the Capacity Schedule for such year.

5.3.4 In the event that ViroPharma submits any Firm Portion for ViroPharma
Product for less than ***% of the quantity of ViroPharma Product anticipated to
be ordered for the same Semiannual Period according to immediately preceding
Semiannual Forecast, Sanquin nevertheless shall have the right to supply and
ship to ViroPharma (in accordance with the shipping instructions most recently
supplied by ViroPharma) ***% of the quantity of ViroPharma Product set forth in
the immediately preceding Semiannual Forecast for such Semiannual Period.
ViroPharma shall notify Sanquin as soon as possible of a decrease in
ViroPharma’s requirements for ViroPharma Product materially below the limits set
forth herein. In the event of such a decrease, Sanquin shall use commercially
reasonable efforts, but shall not be required, to reduce accordingly.

5.3.5 Notwithstanding the foregoing, the Parties may mutually agree to a
forecasting and ordering procedure in advance of a Launch.

“Launch” means as the case may be, the commercial launch of a ViroPharma Product
in a new country in the ViroPharma Territory; a substantial increase in the
amount of ViroPharma Product manufactured by Sanquin or by any Affiliate and/or
subcontractor resulting from capacity expansion as reflected in the Capacity
Schedule; and/or the commercial launch of additional or new dosage strengths
and/or formulations of a ViroPharma Product; and/or the commercial launch of a
ViroPharma Product for new or additional indications.

5.4 Minimum Purchase Requirement.

5.4.1 Notwithstanding any provision in this Agreement to the contrary, in each
calendar year during the Term beginning in calendar year 2016, ViroPharma shall
purchase from Sanquin no less than a minimum quantity of ViroPharma Product as
established by the Parties for such calendar year and as specified in Appendix 1
hereto (the “Annual Minimum Quantity”).

5.4.2 The purchase obligations set forth in Section 5.4.1 are on a take or pay
basis. This means that in the event that ViroPharma does not purchase the Annual
Minimum Quantity during any calendar year, ViroPharma shall be obligated to pay
to Sanquin within *** days following the end of the subject calendar year an
amount equal to the difference in amounts actually paid for the ViroPharma
Product purchased during that calendar year and the amount that would have been
paid had ViroPharma purchased the Annual Minimum Quantity during that calendar
year. The foregoing shall be

 

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Sanquin’s sole remedy for ViroPharma’s failure to meet its obligations under
Section 5.4.1 for such calendar year; provided, however, that, in the event that
ViroPharma breaches its obligations under Section 5.4.1 and also fails to make
the payment described in this Section 5.4.2, then Sanquin shall have the right
to terminate this Agreement in accordance with the provisions of
Section 10.2.1(b) and/or to seek performance of ViroPharma’s payment obligations
under this Section 5.4.2.

5.4.3 The Parties agree that the Annual Minimum Quantity for any calendar year
shall be reasonably and proportionately reduced for such calendar year in the
event that Sanquin and/or Sanquin’s Affiliates fails for any reason (other than
due to the fault of ViroPharma or any Affiliate of ViroPharma), including due to
a Force Majeure Event, to manufacture and deliver ViroPharma Product to
ViroPharma in accordance with the requirements of this Agreement. For the
avoidance of doubt, in the event of a reduction described in this Section 5.4.3,
such reduced amount shall not be carried forward to the following calendar year.

5.4.4 Beginning in 2013, the Parties shall enter into good faith negotiations
for the purpose of establishing the Annual Minimum Quantity for the *** calendar
years beginning in 2016, taking into account all relevant factors, including
product exclusivity in the applicable countries in the ViroPharma Territory, the
competitiveness of alternative products in the market place or under
development, the commercial value of the ViroPharma Product and other relevant
factors. Thereafter, for calendar years subsequent to ***, the Parties shall
similarly enter into good faith negotiations for the purpose of establishing the
Annual Minimum Quantity for such calendar years reasonably in advance of such
calendar years. In all cases, the Parties shall reflect their agreement in
writing in Appendix 1 hereto.

5.5 Conformity.

5.5.1 The ViroPharma Product shall be manufactured by Sanquin at the
Manufacturing Facilities and according to the manufacturing process as set forth
in the Specifications.

5.5.2 The above manufacturing shall include, without limitation, applying all
ViroPharma Product labeling and package inserts and properly packing the
ViroPharma Product for shipment as required by the applicable Regulatory
Authority.

5.5.3 ViroPharma will advise Sanquin in writing of any proposed modifications to
the Specifications. Sanquin shall determine whether such proposed modifications
are feasible from both a technical and a cost-effectiveness perspective and
shall implement said modifications upon written acceptance thereof. Similarly,
Sanquin shall advise ViroPharma in writing of any proposed or required changes
to the Specifications prior to the implementation thereof. The Parties agree
that the procedure for approving changes to the Specifications shall be
elaborated in the Quality Agreement.

 

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5.6 Quality control.

5.6.1 Sanquin shall conduct, or cause to be conducted, quality control testing
of ViroPharma Product prior to shipment to ViroPharma, in accordance with the
Specifications (the “Quality Testing”). The Quality Testing shall include all
release testing as required by the applicable Regulatory Authorities. Sanquin
shall retain records pertaining to the Quality Testing. Each shipment of
ViroPharma Product hereunder shall be accompanied by a certified quality control
protocol and certificate of analysis for each batch of ViroPharma Product
therein.

5.6.2 Sanquin shall make the final ViroPharma Product available for ViroPharma
at Sanquin’s Manufacturing Facility. The final ViroPharma Product shall include
all ViroPharma Product labeling, package inserts, proper packing for shipment
and a certified quality control protocol and certificate of analysis for each
batch of ViroPharma Product as referred to in Section 5.6.1 above. ViroPharma
shall be responsible for collection of such final ViroPharma Product at the
Manufacturing Facility of Sanquin and shipment thereof to ViroPharma.

5.6.3 ViroPharma shall accept or reject the ViroPharma Product in accordance
with the procedures as set forth in the Quality Agreement.

5.7 Shortage of ViroPharma Product.

5.7.1 In addition to the obligations set forth in Section 17.3 relating to a
Force Majeure Event, Sanquin shall notify ViroPharma: (a) as promptly as
possible, but in no event more than *** days after Sanquin’s receipt of a firm
purchase order from ViroPharma, or (b) immediately upon becoming aware of
Sanquin’s inability to supply the quantity of ViroPharma Product to ViroPharma
that Sanquin is required to supply hereunder, of Sanquin’s inability to supply
such quantities of ViroPharma Product. In such event, Sanquin shall allocate all
available resources to remedy such shortage in the manner and to the extent that
Sanquin provides to its ***, including *** in relation to the ***.

5.8 Title to ViroPharma Product.

5.8.1 Title to ViroPharma Product based on ViroPharma Plasma. Title to all
ViroPharma Plasma and residuals thereof, all work in progress to manufacture
ViroPharma Product on the basis of ViroPharma Plasma (including the
Intermediates as manufactured from ViroPharma Plasma), and all completed
ViroPharma Product manufactured on the basis of ViroPharma Plasma shall be in
Viropharma.

5.8.2 Title to ViroPharma Product based on Sanquin Plasma. Title to completed
ViroPharma Product manufactured on the basis of Sanquin Plasma shall transfer to
ViroPharma upon delivery thereof to ViroPharma.

5.9 Quality Agreement. As soon as possible after the Effective Date and in any
event prior to the commencement of manufacturing of any ViroPharma Product
pursuant to this Agreement, the Parties shall enter in a quality agreement (the
“Quality Agreement”) specifying

 

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operational routines between the Parties concerning (among other things) the
origin, collection, delivery, intake, handling, processing, storage and testing
of Plasma (including Sanquin Plasma and ViroPharma Plasma) and the manufacture
(including formulation, filling, testing, packaging, release and procedures for
acceptance and rejection) of ViroPharma Product from such Plasma. The Parties
shall discuss and agree on the terms of the Quality Agreement within the scope
of the JSC. The Quality Agreement will be subject to and consistent with the
terms of this Agreement and the Specifications, and in the event of conflict
between terms of this Agreement and/or the Specifications, as applicable, on the
one hand, and the Quality Agreement on the other hand, this Agreement or the
Specifications, as applicable, will govern, it being agreed that more specific
provisions in the Quality Agreement shall not be deemed a conflict.

ARTICLE 6

PRICING

6.1 Prices for ViroPharma Product and Handling Services.

6.1.1 Purchase Price and Manufacturing Fee.

(a) The Purchase Price for ViroPharma Product shall be as set forth in Appendix
2 (under paragraph A).

(b) The Manufacturing Fee for ViroPharma Product shall be as set forth in
Appendix 2 (under paragraph B).

It is explicitly acknowledged and agreed between the Parties that the Purchase
Price and the Manufacturing Fee as applicable at the Effective Date are based on
(i) the current ViroPharma Product, being freeze dried C1 esterase inhibitor for
the HAE indication through intravenous use, and (ii) commercialization thereof
in the current ViroPharma Territory, being Europe and Rest of World excluding
the Excluded Territory, it being understood that the Excluded Territory
currently includes (amongst others) all countries of North, Central and South
America and Israel (including the Palestinian Authority). The Parties agree to
negotiate in good faith a new Purchase Price and new Manufacturing Fee in the
event of development and commercialization by ViroPharma of any new ViroPharma
Product (including among other things in the event of a new indication or
formulation) for the various countries in the ViroPharma Territory.

6.1.2 Batch release fee. ViroPharma shall pay to Sanquin a batch release fee as
set forth in Appendix 2 (under paragraph E.).

6.1.3 Handling Services fee. ViroPharma shall pay to Sanquin a fee for the
Handling Services as set forth in Appendix 2 (under paragraph F.).

 

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6.1.4 Without prejudice to the annual indexation of the Purchase Price and the
Manufacturing Fee as set out in Appendix 2, the Purchase Price and the
Manufacturing Fee may be increased or decreased in accordance with the
following:

(i) as agreed to by both Parties through good faith negotiations in order to:
(a) cover Sanquin’s *** due to a significant change in manufacturing as a result
of regulatory requirements; or (b) *** as a result of the implementation of any
*** if and to the extent such *** between the Parties and excluding any ***
relating to a modification of the ***, if any, which *** will be exclusively for
the benefit of Sanquin;

(ii) as agreed to by both Parties through good faith negotiations in order to
cover an *** in Sanquin’s *** in relation to this Agreement, if such *** is the
result of a future event that is industry-wide and not the result of an event
for which Sanquin can be blamed; and

(iii) as agreed to by both Parties through good faith negotiations in the event
of a significant change in (a) *** or (b) *** of ViroPharma Product as a result
of regulatory requirements.

6.1.5 In addition to what is set out in Section 6.1.4 above, the Parties
acknowledge and agree that the engagement of a Second Supplier (as referred to
in Section 7.2.1) will lead to extra costs (in relation to the duplication of
the manufacturing facility) which extra costs will lead to ***. The Parties
agree that they shall negotiate in good faith the amounts of such ***.

6.1.6 All fees and prices are in euros and excluding VAT.

6.2 Invoices.

6.2.1 Sanquin shall invoice ViroPharma for the base fee component of the
Purchase Price or the Manufacturing Fee (as the case may be) as well as the
batch release fee for ViroPharma Product upon completion of each purchase order
of ViroPharma Product. All such invoices shall be due and payable within ***
calendar days after the date of invoicing. Sanquin shall reference ViroPharma’s
purchase order on all invoices.

6.2.2 Each calendar year Sanquin shall invoice ViroPharma for the royalty
component of the Purchase Price and/or the Manufacturing Fee, as the case may
be, following the final determination of the net sales for the preceding
calendar year in accordance with paragraph C of Appendix 2. All such invoices
shall be due and payable within *** calendar days after the date of invoicing.

6.2.3 Sanquin shall invoice ViroPharma for the fee for the Handling Services
periodically. All such invoices shall be due and payable within *** calendar
days after the date of invoicing.

6.2.4 In the event of a delay in payment of an invoice, statutory commercial
interest (wettelijke handelsrente) within the meaning of article 6:119a of the
Dutch Civil

 

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Code will be due by ViroPharma with respect to the invoiced amount, such
interest to be calculated over the period as from the date following the due
date of the invoice until and including the date of the actual payment of the
invoice.

ARTICLE 7

CAPACITY SCHEDULE AND SECOND SUPPLIER

7.1 The Capacity Schedule. In the *** the Parties shall within the scope of the
JSC establish a capacity schedule based on the Parties’ good faith estimate of
the total requirements for C1 esterase inhibitor for the next calendar years,
***, which requirements shall comprise both *** as well as *** These total
requirements shall be balanced against Sanquin’s aggregate manufacturing
capacity for C1 esterase inhibitor (including the capacity of any Affiliate
and/or subcontractor capable of acting as a Second Supplier (as defined in
Section 7.2.1), if any) (the “Capacity Schedule”). The Capacity Schedule shall
be updated within the scope of the JSC no less frequently than annually, and
shall include projects identified by the Parties to enhance manufacturing
capacity. Furthermore as soon as practicable beginning in ***, the Parties shall
negotiate in good faith, taking into account all applicable factors, to
establish the Capacity Schedule for the next *** calendar years after ***, and
so on.

7.2 Second Supplier.

7.2.1 Sanquin shall enter into one or more manufacturing agreement(s)
(“Subcontracting Agreement”), as the case may be, with one or more third party
manufacturer(s), reasonably acceptable to ViroPharma, including possibly
CAF-DCF, (“Second Supplier”), pursuant to which Subcontracting Agreement the
Second Supplier shall be in a position to manufacture certain quantities of
ViroPharma Product for the HAE-indication to be agreed upon by the Parties and
to be included in the Capacity Schedule, and to provide for a back-up
manufacturing facility in order to reasonably secure the manufacturing of
ViroPharma Product under this Agreement (including in the event that Sanquin’s
Manufacturing Facility is temporarily out of operation). Timing of the entry
into of the Subcontracting Agreement, the terms of the Subcontracting Agreement
(including but not limited to prices) and the identity of the Second Supplier
shall be discussed and agreed between the Parties within the scope of the JSC.
Sanquin shall provide ViroPharma with a complete and accurate copy of each
Subcontracting Agreement and any subsequent amendments, all of which shall be in
writing.

7.2.2 In addition, in the event of any of the following events occurring during
the Term:

(a) the sale, lease, transfer, conveyance, or other disposition of all or
substantially all of Sanquin’s assets;

(b) the dissolution of Sanquin;

(c) ViroPharma’s termination of this Agreement as a result of Sanquin’s uncured
material breach;

 

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(d) Sanquin’s termination of this Agreement in accordance with Section 10.1.1
below (for the avoidance of doubt: such event not including the termination of
this Agreement upon expiry of the 18-year-renewal period as referred to in
Section 10.1.1);

(e) Sanquin files for bankruptcy;

(f) a Force Majeure Event,

and only if such event shall result in Sanquin (including any successor of
Sanquin) permanently ceasing to manufacture the ViroPharma Product, Sanquin
hereby (i) grants and shall grant to ViroPharma a *** (except as set forth in
Section 7.2.4) perpetual license and access to the Sanquin Technology; and
(ii) assigns and shall assign to ViroPharma each of the Subcontracting
Agreements; provided that Sanquin shall remain liable with respect to any
liabilities or obligations thereunder relating to the period prior to the
effective date of such assignment. Each Subcontracting Agreement shall provide
that the Second Supplier shall in such event still be entitled to use the
Sanquin Technology in order to manufacture the ViroPharma Product for ViroPharma
and shall have assignment provisions consistent with this paragraph.

7.2.3 Sanquin shall notify ViroPharma as promptly as reasonably possible upon
becoming aware that any of the events as set out in Section 7.2.2 above is
anticipated to occur or has occurred, as the case may be.

7.2.4 In the event that ViroPharma is granted a license and gets access to the
Sanquin Technology pursuant to Section 7.2.2 above, ViroPharma will make a
one-time payment to Sanquin (or any resulting successor company) in the amount
of ***); provided, however, that ViroPharma will not be obliged to make such
payment if such payment has already been made by any of ViroPharma’s Affiliates.
ViroPharma will make an additional payment to Sanquin for the time and material
relating to and in connection with the transfer by Sanquin to ViroPharma of any
Sanquin Technology beyond the Sanquin Technology related to the isolation of the
active compound C1 esterase inhibitor, it being understood that the amount of
such payment shall be agreed upon between the Parties through good faith
negotiations. In addition to the aforementioned payment(s), ViroPharma will pay
to Sanquin (or any resulting successor company) a royalty fee in the amount of
***% on net sales of ViroPharma Product in the ViroPharma Territory for a period
of *** years, starting on the first day of the calendar *** immediately
following the calendar *** in which ViroPharma is granted a license as set out
in Section 7.2.2; each such year hereinafter referred to as a “Reference Year”.
Such net sales of ViroPharma Product shall be determined as set out in Appendix
4. For the purposes of this Section 7.2.4 and Appendix 4, the term “ViroPharma
Product” shall also include any other C1 esterase inhibitor plasma-derived
product.

7.2.5 Sanquin shall invoice ViroPharma for the royalty fee for each Reference
Year following the final determination of the net sales in such Reference Year
in accordance with Appendix 4. All such invoices shall be due and payable within
*** calendar days after the date of invoicing.

 

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ARTICLE 8

REPRESENTATIONS, WARRANTIES, AND COVENANTS

8.1 ViroPharma Product Warranties from Sanquin. Sanquin hereby represents and
warrants to ViroPharma as of the date of the delivery of ViroPharma Product to
ViroPharma as follows: (a) such ViroPharma Product is in conformity with the
Specifications; (b) such ViroPharma Product has been manufactured in conformance
with cGMP, all other Applicable Law, this Agreement and the Quality Agreement;
(c) title to such ViroPharma Product if and to the extent manufactured on the
basis of Sanquin Plasma will pass to ViroPharma free and clear of any security
interest, lien or other encumbrance; (d) such ViroPharma Product has been
manufactured in facilities that are in compliance with Applicable Law at the
time of such manufacture (including applicable inspection requirements of EMEA
and other Regulatory Authorities); (e) the expiration date of such ViroPharma
Product is no earlier than *** months after the date of delivery thereof;
(f) such ViroPharma Product has not been adulterated or misbranded, and similar
provisions of other Applicable Law; and (g) neither Sanquin nor any of its
Affiliates has been debarred or is subject to debarment pursuant to Section 306
of the Federal Food, Drugs and Cosmetics Act, or any similar law in any country
in the ViroPharma Territory.

8.2 ViroPharma Product Warranties from ViroPharma. ViroPharma hereby represents
and warrants to Sanquin as follows: (a) ViroPharma shall import, use, sell and
offer for sale the ViroPharma Product in the ViroPharma Territory in accordance
with the Regulatory Approvals, good distribution practices and Applicable Law;
(b) the ViroPharma Plasma as supplied by ViroPharma to Sanquin for the
manufacturing of ViroPharma Product is in conformity with the Specifications,
all other Applicable Law, this Agreement and the Quality Agreement;
(c) ViroPharma, its Affiliates and any Person granted a sublicense by ViroPharma
to distribute any ViroPharma Product are duly authorized to distribute
ViroPharma Product in the ViroPharma Territory.

8.3 Additional Representations and Warranties.

8.3.1 By ViroPharma. ViroPharma hereby represents and warrants to Sanquin that
(a) it is a private limited liability company duly organized and existing under
the laws of Belgium; (b) it has the requisite authority to enter into this
Agreement and to perform its obligations hereunder; (c) it has obtained all
necessary corporate approvals to enter into this Agreement; (d) this Agreement
is a legal, valid and binding agreement of ViroPharma, enforceable against
ViroPharma in accordance with its terms, subject to applicable limitations on
such enforcement based on bankruptcy laws and other debtors’ rights; (e) it is
not aware of any contractual or other restriction, limitation or condition which
might affect adversely its ability to perform hereunder; and (f) it is in
material compliance with all laws and regulations applicable to conduct of its
business.

8.3.2 By Sanquin. Sanquin hereby represents and warrants to ViroPharma that
(a) it is a foundation organized and existing under the laws of The Netherlands;
(b) it has the corporate authority to enter into this Agreement and to perform
its obligations hereunder; (c) it has obtained all necessary corporate approvals
to enter into this Agreement; (d) this Agreement is a legal, valid and binding
agreement of Sanquin

 

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enforceable against Sanquin in accordance with its terms, subject to applicable
limitations on such enforcement based on bankruptcy laws and other debtors’
rights; (e) the Cetor Product is approved for marketing and sale for hereditary
angeoedema by the Dutch Medicines Evaluation Board; (f) there are no contractual
or other restriction, limitation or condition which would affect adversely
Sanquin’s ability to perform its obligations hereunder, or limit or otherwise
restrict Sanquin from granting the licenses and other rights to the Sanquin
Technology granted hereunder; (g) it is in material compliance with all
Applicable Law; (h) it has sufficient capacity, facilities and employees with
the requisite skill and experience to manufacture ViroPharma Product conforming
to the warranty set forth in Section 8.1 hereof, and (i) there is no Third Party
intellectual property which would be infringed as a result of manufacturing the
ViroPharma Product in accordance with this Agreement.

8.4 Information Rights. Annually, (a) prior to ***, ViroPharma shall provide to
Sanquin a copy of ViroPharma’s unaudited financial statements, compliant with US
GAAP; and (b) prior to ***, ViroPharma shall provide to Sanquin a copy of
ViroPharma’s audited financial statements, compliant with Belgian statutory
requirements.

ARTICLE 9

INSPECTIONS

9.1 ViroPharma Inspections. Sanquin agrees that ViroPharma shall have the right
from time to time, upon reasonable prior notice to Sanquin and during normal
business hours, to inspect the Manufacturing Facilities as well as the
manufacturing of each ViroPharma Product, including inspection of (a) the raw
materials (including without limitation the Plasma) used in the manufacture of
the ViroPharma Product, (b) the holding facilities for such raw materials,
(c) the equipment used in the manufacture of the ViroPharma Product, and (d) all
records relating to such manufacturing and the Manufacturing Facilities (to the
extent they relate to the ViroPharma Product). Following any such inspection,
ViroPharma shall discuss its observations and conclusions with Sanquin and
Sanquin shall implement such corrective actions as may be reasonably determined
by ViroPharma and if required pursuant to Applicable Law within such period as
may be agreed by the Parties.

9.2 Sanquin Inspections. ViroPharma agrees that Sanquin shall have the right
from time to time, upon reasonable prior notice to ViroPharma and during normal
business hours, to inspect the ViroPharma Plasma collection centers,
ViroPharma’s distribution channels as well as the performance by ViroPharma of
its pharmacovigilance obligations under the PV Agreement. Following any such
inspection, Sanquin shall discuss its observations and conclusions with
ViroPharma and if required pursuant to Applicable Law, ViroPharma shall
implement such corrective actions as may be reasonably determined by Sanquin and
within such period as may be agreed by the Parties.

9.3 Regulatory Inspections. Each Party shall notify the other Party by telephone
within *** hours, and in writing within *** Business Days, after learning of any
proposed visit to, or inspection of, a Manufacturing Facility by any Regulatory
Authority and promptly by telephone after learning of any unannounced visit to,
or inspection of, a Manufacturing Facility

 

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by any Regulatory Authority, and Sanquin shall permit ViroPharma or its
representatives to be present and participate in such visit or inspection. Each
Party shall provide to the other Party a copy of any report and other written
communications received from such Regulatory Authority in connection with such
visit or inspection, and any written communications received from such
Regulatory Authority, in each case relating to the ViroPharma Product or any
equipment or manufacturing process used in connection with the manufacture of
the ViroPharma Product, within *** Business Days after receipt thereof.
Furthermore each Party shall provide the other Party with a copy of all draft
responses and all final responses for review and comment as soon as reasonably
practicable. Notwithstanding the foregoing, Sanquin has the sole right to
determine the contents and form of any communication with, or response to, any
such Regulatory Authority.

ARTICLE 10

TERM AND TERMINATION

10.1 Term. The initial term of this Agreement shall commence as of the Effective
Date and end on December 31, 2019 (the “Term”). The parties hereby agree to the
following:

10.1.1 The Term of this Agreement shall be automatically extended for up to
eighteen (18) additional years by way of six (6) three (3) year renewal periods.
Each Party may terminate this Agreement at the end of the Term or any subsequent
renewal period, provided that ViroPharma shall provide written notice of
termination to Sanquin at least two (2) years prior to the date of expiration of
a contract period and Sanquin shall provide written notice of termination to
ViroPharma at least three (3) years prior to the date of expiration of a
contract period, it being understood that the Agreement will terminate
automatically upon expiry of the eighteen (18) year renewal period (without the
requirement of giving notice of termination or taking into account a notice
period).

10.1.2 This Agreement may be further extended by the mutual written agreement of
the Parties at any time prior to its expiration.

10.2 Termination. Each Party shall have the right to terminate this Agreement by
giving the other Party written notice if:

10.2.1 the other Party is in material breach of this Agreement, and such failure
continues unremedied for a period of thirty (30) days after the date the
notifying Party gives written notice to the defaulting Party with respect
thereto. The Parties agree that in any case the following events are to be
considered a material breach of this Agreement:

(a) ViroPharma fails in a period of *** consecutive months, for whatever reason,
to settle and pay *** invoices for the Purchase Price and/or the Manufacturing
Fee for the ViroPharma Product within the contractual payment term set out in
Section 6.2.1 above;

(b) ViroPharma fails to comply with the provisions of Section 5.4 of this
Agreement, concerning the Annual Minimum Quantity (subject to Sanquin supplying
sufficient quantities of ViroPharma Product as ordered by ViroPharma); or

 

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(c) ViroPharma or ViroPharma Incorporated enters into any agreement to *** with
a Competitor without the prior written consent of Sanquin.

10.2.2 the other Party (a) applies for or consents to the appointment of a
receiver, trustee, liquidator or custodian of itself or of all or a substantial
part of its assets, (b) makes a general assignment for the benefit of its
creditors, (c) commences a voluntary case of bankruptcy or consents to any
bankruptcy or restructuring relief or to the appointment of or taking possession
of its property by any official in such case or such other proceeding commenced
against it, or (d) takes any corporate action for the purpose of effecting any
of the foregoing.

10.3 Termination of ViroPharma Product. ViroPharma may discontinue or otherwise
terminate its commercial activities with respect to any ViroPharma Product, or
part of the ViroPharma Territory without terminating this Agreement, without
prejudice to Sanquin’s rights as set out in Section 4.1.5 and without prejudice
to ViroPharma’s minimum annual purchase obligations as referred to in Sections
5.3.4 and 5.4.

10.4 Effect of Expiration or Termination.

10.4.1 The expiration or earlier termination of this Agreement shall be without
prejudice to any rights or obligations of the Parties that may have accrued
prior to such termination, and the provisions of Sections 1.1 (Definitions),
3.2.12, 4.1.6, 4.2.2 (Product recalls), 4.2.3 (Retention of samples and
documentation), 7.2.4, 10.4 (Effect of expiration), Sections 13.1, 13.2, 13.3,
13.4 and 13.5, Article 14 (Governing law/dispute resolution), Article 16
(Confidentiality), Section 17.6 (Notices), shall survive the expiration or
termination of this Agreement. Except as otherwise expressly provided herein,
termination of this Agreement in accordance with the provisions hereof shall not
limit remedies that may otherwise be available at law or in equity.

10.4.2 Upon expiration or earlier termination of this Agreement, each Party, at
the request of the other, shall return all data, files, records and other
materials in its possession or control containing or comprising the other
Party’s Confidential Information.

10.4.3 Upon expiration or termination of this Agreement for any reason the
Parties shall consult with each other in order to settle any outstanding
obligations under this Agreement (to the extent possible), (a) ViroPharma shall
have the right to sell off all ViroPharma Product in its inventory as of the
date of expiration or termination, provided that all fees in respect of such
ViroPharma Product have been paid to Sanquin, and (b) Sanquin shall have the
right to retain all ViroPharma Product and Intermediates in Sanquin’s and/or
CAF-DCF’s storage as of the date of expiration or termination, unless in the
event of payment by ViroPharma of all fees due in relation to such ViroPharma
Product.

 

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10.4.4 In the event of termination of this Agreement as a result of a material
breach of this Agreement by ViroPharma as referred to in Section 10.2.1 under
(a), (b) or (c), Sanquin shall *** ViroPharma’s rights to the Regulatory
Approvals as obtained by ViroPharma and/or the applications for Regulatory
Approvals as filed by ViroPharma under this Agreement.

ARTICLE 11

CHANGE OF CONTROL VIROPHARMA AND VIROPHARMA INCORPORATED

11.1 Prior to ViroPharma and/or ViroPharma Incorporated entering into any
agreement to merge, be acquired or sell substantially all of its assets to
another company, ViroPharma shall give Sanquin the opportunity to conduct due
diligence to establish that said company is not to be considered as a
Competitor.

11.2 ViroPharma shall not and ViroPharma shall procure that ViroPharma
Incorporated shall not enter into any agreement to merge, be acquired or sell
substantially all of its assets with a Competitor without the prior written
consent of Sanquin, which shall not be unreasonably withheld.

11.3 ViroPharma agrees that any surviving entity in a merger, acquirer of
assets, or any other successor of ViroPharma shall be bound by and subject to
all of the terms and conditions of this Agreement.

ARTICLE 12

NON-COMPETE

12.1 As from the Effective Date up to 31 December 2019, ViroPharma, its
Affiliates and its Sublicensees shall not distribute, market, offer for sale,
sell, import or promote any Competitive Product in the ViroPharma Territory,
except with the consent of Sanquin.

“Competitive Product” means any pharmaceutical product, other than a Product or
a ViroPharma Product, that (a) is a C1 esterase inhibitor or any other
pharmaceutical product with C1 esterase inhibitor like actions (whether or not
derived from Plasma); (b) is approved for commercial sale in the applicable
country in the ViroPharma Territory; and (c) is sold with a label that includes
indications substantially identical to any indication for the Product or the
ViroPharma Product in the applicable country in the ViroPharma Territory.

ARTICLE 13

INDEMNIFICATION AND INSURANCE

13.1 Indemnification of ViroPharma. Sanquin shall indemnify, hold harmless and
defend ViroPharma and its Affiliates from and against any and all claims,
actions, causes of action, judgments, awards, liabilities, taxes, losses, costs
or damages, all of which within the meaning of articles 6:95 and 6:96 Dutch
Civil Code, as well as reasonable attorneys’ fees (collectively, the “Losses”)
suffered by them, to the extent arising out of or resulting from (a)

 

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Sanquin’s infringement of any Third Party’s intellectual property as a result of
the manufacturing of any ViroPharma Product, (b) Sanquin’s breach of this
Agreement, or (c) Sanquin’s negligence or willful misconduct, in each case
except to the extent ViroPharma has an obligation to indemnify Sanquin therefore
in accordance with Section 13.2 hereof.

13.2 Indemnification of Sanquin. ViroPharma shall indemnify, hold harmless and
defend Sanquin and its Affiliates (including CAF-DCF) from and against any and
all Losses, suffered by them, which arise out of or result from (a) ViroPharma’s
infringement of any Third Party’s intellectual property as a result of the sale
of any ViroPharma Product in the ViroPharma Territory (b) a breach by ViroPharma
of the terms of this Agreement, or (c) ViroPharma’s negligence or willful
misconduct, in each case except to the extent Sanquin has an obligation to
indemnify ViroPharma therefore in accordance with Section 13.1 hereof.

13.3 Limitation. ViroPharma and Sanquin explicitly accept and agree that under
no circumstance within the scope of the present contractual relationship between
both Parties, shall one Party be required to indemnify the other Party against
punitive damages, exemplary damages, pain and suffering, and loss of
compensation, arising out or related to the breach of any representation,
warranty or other contractual obligation by a Party.

13.4 Notice of Claims. If any Party to be indemnified under this Article 13 (the
“Indemnified Party”) has suffered or incurred any Loss, the Indemnified Party
shall so notify the party from whom indemnification is sought (the “Indemnifying
Party”) promptly in writing describing such Loss, the amount or estimated amount
thereof, if known or reasonably capable of estimation, and the method of
computation of such Loss, all with reasonable particularity and containing a
reference to the provisions of this Agreement or any other agreement, instrument
or certificate delivered pursuant hereto in respect of which such Loss shall
have occurred. If any action at law or suit in equity is instituted by a Third
Party (a “Third Party Claim”) with respect to which the Indemnified Party
intends to claim any liability as a Loss, the Indemnified Party shall promptly
give written notification (the “Third Party Claim Notice”) to the Indemnifying
Party of such Third Party Claim and offer to tender to the Indemnifying Party
the defense of such Third Party Claim. A failure by the Indemnified Party to
give notice and to offer to tender the defense of the Third Party Claim in a
timely manner pursuant to this Section 13.4 shall not limit the obligation of
the Indemnifying Party under this Article 13, except to the extent such
Indemnifying Party is prejudiced thereby.

13.5 Third Party Claims.

13.5.1 The Indemnifying Party shall have the right, but not the obligation,
exercisable by written notice to the Indemnified Party within *** days of
receipt of a Third Party Claim Notice from the Indemnified Party with respect
thereto, to assume the conduct and control, at the expense of the Indemnifying
Party and through counsel of its choosing that is reasonably acceptable to the
Indemnified Party any Third Party Claim, and the Indemnifying Party may
compromise or settle the same, provided that the Indemnifying Party shall obtain
the prior written consent of the Indemnified Party for any proposed compromise
or settlement, except in the case of any settlement that is on solely monetary
terms, will be indemnified in full by the Indemnifying Party and provides for no
admission of liability on the part of the Indemnified Party. No Indemnified
Party may

 

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compromise or settle any Third Party Claim for which it is seeking
indemnification hereunder without the consent of the Indemnifying Party. The
Indemnifying Party shall permit the Indemnified Party to participate in, but not
control, the defense of any such action or suit through counsel chosen by the
Indemnified Party, provided that the fees and expenses of such counsel shall be
borne by the Indemnified Party. If the Indemnifying Party elects not to control
or conduct the defense of a Third Party Claim, the Indemnifying Party
nevertheless shall have the right to participate in the defense of any Third
Party Claim and, at its own expense, to employ counsel of its own choosing for
such purpose.

13.5.2 The parties hereto shall cooperate in the defense of any Third Party
Claim, with such cooperation to include (a) the retention and the provision of
the Indemnifying Party records and information that are reasonably relevant to
such Third Party Claim, and (b) reasonable access to employees on a mutually
convenient basis for providing additional information and explanation of any
material provided hereunder.

13.6 Insurance. Each Party represents and warrants that it is sufficiently self
insured or insured against any liability arising under this Article 13.

ARTICLE 14

GOVERNING LAW; DISPUTE RESOLUTION

14.1 Governing Law. This Agreement is governed by, and all disputes arising
under or in connection with this Agreement shall be resolved in accordance with,
the laws of The Netherlands (to the exclusion of the United Nations Convention
on Contracts for the International Sale of Goods (CISG)).

14.2 The Parties shall endeavor to resolve any dispute arising out of or in
connection with this Agreement by negotiation. If, within *** days after written
notice by either Party of the existence of a dispute, the Parties do not resolve
such dispute, then the dispute shall be referred to a representative for each
Party for further negotiation. Any dispute arising out of or in connection with
this Agreement which remains unresolved *** days after either Party gives
written notice of the existence of such dispute shall be finally resolved by
arbitration in accordance with the Rules of the Netherlands Arbitration
Institute. The arbitral tribunal shall comprise of three arbitrators. The place
of arbitration shall be Amsterdam, the Netherlands. The language to be used in
arbitration shall be English. The arbitral tribunal shall decide in accordance
with the rules of law. This Section 14.2 is without prejudice to Section 14.4
and the provisions in Appendix 2 under paragraph C and the provisions in
Appendix 4 regarding the determination of net sales by an Expert.

14.3 Confidentiality. The Parties undertake to keep confidential all awards in
their arbitration, together with all materials in the proceedings created for
the purpose of the arbitration and all other documents produced by another Party
in the proceedings not otherwise in the public domain, save and to the extent
that disclosure may be required of a party by legal duty, to protect or pursue a
legal right or to enforce or challenge an award in legal proceedings before a
court or other judicial authority.

 

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14.4 Notwithstanding the foregoing, either Party has the right to apply to any
court of competent jurisdiction for provisional relief, including pre-arbitral
attachments, a temporary restraining order, temporary injunction, permanent
injunction and/or order of specific performance, as may appear reasonably
necessary to preserve the rights of either Party. The application by either
party to a judicial authority for such measures shall not be deemed to be an
infringement or a waiver of the arbitration agreement and shall not affect the
relevant powers reserved to the arbitrator.

14.5 Domicile. For the purposes of the service (betekening) of any litigation
and arbitration documents such as a writ of summons, a statement of claim, a
legal judgment or arbitration award under this Agreement, ViroPharma elects to
have its domicile (woonplaats) at: the offices of DLA Piper Nederland N.V.,
Gebouw Meerpark, Amstelveenseweg 638, 1081 JJ, Amsterdam, The Netherlands, or
such other address for which notice is duly given under this Agreement.
Simultaneously with the service of any such litigation or arbitration document
in accordance with the aforementioned, Sanquin shall send a copy of such
document to ViroPharma by telecopy or by e-mail in accordance with Section 17.6;
provided that service shall not be effective in the absence of such simultaneous
transmission by telecopy or e-mail.

ARTICLE 15

INTELLECTUAL PROPERTY

15.1 Ownership of the Sanquin Technology. ViroPharma acknowledges and agrees
that Sanquin is the sole owner of the Sanquin Technology.

15.2 Ownership of Inventions and Technology.

15.2.1 Without prejudice and subject to what is set out in Section 3.2 above
with respect to ownership of inventions and technology, as between Sanquin and
ViroPharma:

(a) Except for Joint Rights, Sanquin shall solely own all data, information,
materials, inventions and any and all intellectual property rights in the
foregoing, created and/or invented by employees of Sanquin and/or persons or
entities obligated to assign to Sanquin such data, information, materials and
inventions and intellectual property rights therein;

(b) Except for Joint Rights, ViroPharma shall solely own all data, information,
materials, inventions and any and all intellectual property rights in the
foregoing, created and/or invented by employees of ViroPharma and/or persons or
entities obligated to assign to ViroPharma such data, information, materials and
inventions and intellectual property rights therein;

(c) Sanquin and ViroPharma shall jointly own all data, information, materials
and inventions and intellectual property rights therein, created and/or invented
jointly by an employee(s) of Sanquin and an employee(s) of ViroPharma (“Joint
Rights”).

 

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ARTICLE 16

CONFIDENTIALITY

16.1 Non-Disclosure. The Receiving Party agrees not to disclose Confidential
Information of the Disclosing Party to a Third Party or to an Affiliate and to
use Confidential Information of the Disclosing Party only for the purposes of
this Agreement. For the avoidance of doubt: any and all information that is
included in or filed with respect to Regulatory Approvals shall be deemed
Confidential Information.

16.2 Exclusions to Confidentiality. The restrictions contained in Section 16.1
shall not apply to Confidential Information that (i) is submitted by the
Receiving Party to Regulatory Authorities to facilitate the issuance of
Regulatory Approvals, provided that reasonable measures shall be taken to assure
confidential treatment of such information; or (ii) is otherwise required to be
disclosed in compliance with Applicable Law or applicable regulations
(including, without limitation, to comply with SEC, NASDAQ or stock exchange
disclosure requirements) or order by a court or other regulatory body having
competent jurisdiction; provided that if a Party is required to make any such
disclosure of the other Party’s Confidential Information it will give reasonable
advance notice to the other Party of such disclosure requirement and will use
its best efforts to secure confidential treatment of such Confidential
Information required to be disclosed.

16.3 Liability. A Party shall be liable for a breach of the obligations of this
Article 16 by an employee or agent of such Party.

16.4 Return of Confidential Information. Upon termination of this Agreement,
upon the first request of the Disclosing Party, the Receiving Party shall
promptly return to the Disclosing Party the Disclosing Party’s Confidential
Information (other than inventions owned by both Parties), including all copies
thereof, except to the extent that retention of such Confidential Information is
reasonably necessary for the Receiving Party to fulfill its obligations
contemplated hereby, including its obligations of confidentiality, nondisclosure
and nonuse hereunder. At the Disclosing Party’s written request, the
Confidential Information that is otherwise required to be returned to the
Disclosing Party shall be destroyed and such destruction shall be certified in
writing to the Disclosing Party by an authorized officer of the Receiving Party.
The return and/or destruction of such Confidential Information as provided above
shall not relieve the Receiving Party of its other obligations under this
Agreement.

ARTICLE 17

GENERAL

17.1 Waiver. A failure by one of the Parties to this Agreement to assert its
rights for or upon any breach or default of this Agreement shall not be deemed a
waiver of such rights nor shall any such waiver be implied from acceptance of
any payment. No such failure or waiver in writing by any one of the Parties
hereto with respect to any rights shall extend to or affect any subsequent
breach or impair any right consequent thereon.

 

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17.2 Severability. The Parties agree that it is the intention of neither Party
to violate any public policy, statutory or common laws, and governmental or
supranational regulations and if any provision of this Agreement is or becomes
invalid or non-binding, the Parties shall remain bound by all other provisions
hereof. In that event, the Parties shall replace the invalid or non-binding
provision by a provision that is valid and binding and that has, to the greatest
extent possible, a similar effect as the invalid or non-binding provision, given
the contents and purpose of this Agreement.

17.3 Force Majeure. If either Party is prevented from complying, either totally
or in part, with any of the terms or provisions set forth in this Agreement by
reason of force majeure, including, by way of example and not of limitation,
acts of God, war, insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm, labor disturbances
including strikes or lockouts, epidemic or failure of suppliers, public
utilities or common carriers, or any other similar or dissimilar cause, in each
case to the extent beyond its control despite having used commercially
reasonable efforts to avoid, minimize, and resolve such cause as promptly as
possible (each, a “Force Majeure Event”), such Party shall (a) provide written
notice of same to the other Party, and (b) subject to its following obligations
with respect to such Party’s efforts to remove the disability, its obligations
that are prevented from compliance by such Force Majeure Event are suspended,
without liability, during such period, and neither Party shall be liable to the
other in damages for, nor shall this Agreement be terminable by reason of, such
Force Majeure Event. The Party prevented from performing hereunder shall use its
commercially reasonably efforts to remove such disability as promptly as
possible and shall continue performance whenever, and to the extent, such causes
are removed. The Party so affected shall provide to the other Party a good faith
estimate of the continuing effect of the Force Majeure Event and the duration of
the affected Party’s non-performance, and periodic updates on a reasonable
basis.

17.4 Independent Contractors. It is not the intent of the Parties hereto to form
any partnership or joint venture. Each Party shall, in relation to its
obligations hereunder, act as an independent contractor, and nothing in this
Agreement shall be construed to give such party the power or authority to act
for, bind or commit the other Party in any way whatsoever.

17.5 Assignment.

17.5.1 This Agreement shall be binding upon and inure to the benefit of the
Parties, their successors and permitted assigns. Neither Party may assign this
Agreement without the prior written consent of the non assigning Party provided,
however, that:

(a) ViroPharma shall have the right, from time to time and without the necessity
of providing notice to, or obtaining the consent of, Sanquin, and without
complying with the provisions of Section 2.3, to delegate, assign, and/or
subcontract this Agreement, or any right or obligation hereunder, to any
Affiliate for any purpose. In all cases, ViroPharma shall remain responsible to
Sanquin for the performance of all such obligations under this Agreement;

(b) Sanquin shall have the right, from time to time and without the necessity of
providing notice to, or obtaining the consent of, ViroPharma, to

 

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delegate, assign, and/or subcontract this Agreement, or any right or obligation
hereunder, to any Affiliate for any purpose. In all cases, Sanquin shall remain
responsible to ViroPharma for the performance of all such obligations under this
Agreement.

17.6 Notices. Without prejudice to Section 14.5 above, all notices and other
communications required or desired to be given or sent by one Party to the other
Party shall be in writing, in the English language, and shall be deemed to have
been given (a) on the date of delivery, if delivered to the persons identified
below, (b) five calendar days after mailing if mailed, with proper postage, by
certified or registered airmail, postage prepaid, return receipt requested,
addressed as set forth below, (c) on the date of receipt if sent by telecopy or
by e-mail, and confirmed in writing in the manner set forth in subsection (b) on
or before the next day after the sending of the telecopy or e-mail, as the case
may be, or (d) two (2) Business Days after delivered to an internationally
recognized overnight courier service marked for overnight delivery, as follows:

To Sanquin:

Stichting Sanquin Bloedvoorziening

Plesmanlaan 125

1066 CX Amsterdam

The Netherlands

Attn: Managing director of the Plasma Products Division

Telephone: + 31 20 512 3744

Telecopy: + 31 20 512 3794

E-mail: r.tiebout@sanquin.nl, with a copy to: robert.tiebout@caf-dcf.redcross.be

With a copy to:

Stichting Sanquin Bloedvoorziening

Plesmanlaan 125

1066 CX Amsterdam

The Netherlands

Attn: Corporate Secretary

Telephone: +31 20 512 3769

Telecopy: +31 20 512 3303

E-mail: m.debruijn@sanquin.nl

To ViroPharma:

ViroPharma SPRL

Square de Meeûs 37

1000 Brussels

Belgium

Attn: General Manager

Telephone: +32 2 747 09 71

Telecopy: +32 2 747 09 42

Email: Marco.carli@viropharma.com

 

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With a copy to:

ViroPharma SPRL

Square de Meeûs 37

1000 Brussels

Belgium

Attn: Legal Counsel Europe

Telephone: +32 2 747 09 71

Telecopy: +32 2 747 09 42

Email: Christelle.Roessig@viropharma.com

Any Party may change such Party’s address for notices by notice duly given
pursuant to this Section 17.6.

17.7 Entire Agreement. This Agreement, together with the Quality Agreement (to
be entered into) and the PV Agreement (to be entered into), constitutes the
entire agreement between the Parties with respect to the subject matter hereof
and supersedes and replaces all prior agreements, understandings, writings and
discussions between the Parties, including but not limited to the Letter
Agreement, and may not be amended except by a written instrument executed by all
Parties.

17.8 Captions. The captions in this Agreement are solely for convenience of
reference and shall not be used for purposes of interpreting or construing the
provisions hereof.

17.9 Counterparts. This Agreement may be executed in one or more counterparts,
each of which shall be deemed to be an original, but all of which together shall
constitute one and the same agreement.

 

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In witness whereof, each of the parties to this Agreement has caused this
Agreement to be executed personally or, as appropriate, by its duly authorized
officers as of the date first above written.

 

STICHTING SANQUIN BLOEDVOORZIENING

(SANQUIN BLOOD SUPPLY FOUNDATION)

    VIROPHARMA SPRL By:  

/s/ T.J.F. Buunen

    By:  

/s/ Marco Carli

Name:  

T.J.F. Buunen

    Name:  

Marco Carli

Title:   Chairman     Title:   General Manager

 

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PARENT GUARANTY

Upon a Bankruptcy Event, ViroPharma Incorporated, a corporation organized under
the laws of the State of Delaware, United States of America, hereby agrees to
guaranty the performance by ViroPharma SPRL of each and every covenant,
agreement and obligation set forth in the Manufacturing and Distribution
Services Agreement (Europe and ROW) to which this guaranty is attached, when and
as due in accordance with the terms of such Manufacturing and Distribution
Services Agreement (Europe and ROW). The term “Bankruptcy Event” means, and this
guaranty shall only become effective upon, the filing of a petition for
bankruptcy of ViroPharma SPRL or any application for any equivalent insolvency
proceedings in respect of ViroPharma SPRL. This guaranty shall be governed by
and interpreted in accordance with the laws of the Netherlands, excluding any
conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this guaranty to the substantive law of
another jurisdiction.

ViroPharma Incorporated hereby submits to, and agrees to be bound by: (a) the
dispute resolution provisions set forth in Article 14 of the Manufacturing and
Distribution Services Agreement (Europe and ROW), (b) the change of control
provision set forth in Article 11 of the Manufacturing and Distribution Services
Agreement (Europe and ROW), (c) the confidentiality provisions set forth in
Article 16 of the Manufacturing and Distribution Services Agreement (Europe and
ROW), and (d) the notice provisions set forth in Section 17.6 of the
Manufacturing and Distribution Services Agreement (Europe and ROW), and the
notice information for such purposes is:

ViroPharma Incorporated

730 Stockton Drive

Exton, Pennsylvania 19341

USA

Attn: CEO

Telephone: 1 (610) 458-7300

Telecopy: (610) 458-7380

Email: Vincent.Milano@viropharma.com

With a copy to:

ViroPharma Incorporated

730 Stockton Drive

Exton, Pennsylvania 19341

USA

Attn: General Counsel

Telephone: 1 (610) 458-7300

Telecopy: (610) 458-7380

Email: Peter.Wolf@viropharma.com

For the purposes of the service (betekening) of litigation and arbitration
documents such as a writ of summons, a statement of claim, a legal judgment or
arbitration award under this Parent Guarantee, ViroPharma Incorporated elects to
have its domicile (woonplaats) at: the offices of DLA Piper Nederland N.V.,
Gebouw Meerpark, Amstelveensweg 638, 1081 JJ, Amsterdam, The

 

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Netherlands, or such other address for which notice is duly given under this
Agreement. Simultaneously with the service of any such litigation or arbitration
document in accordance with the aforementioned, Sanquin shall send a copy of
such document to ViroPharma Incorporated by telecopy or by e-mail in accordance
with Section 17.6; provided that service shall not be effective in the absence
of such simultaneous transmission by telecopy or e-mail.

 

ViroPharma Incorporated By:  

/s/ Vincent Milano

Name:  

Vincent Milano

Title:  

President, CEO and Chairman

 

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Appendix 1 – Annual Minimum Quantity (in million Units1 per calendar year)

 

Calendar year

  

Annual Minimum Quantity

***    *** ***    *** ***    *** ***    *** ***    *** ***    *** ***and onwards
   ***

 

1

including Units of ViroPharma Product as manufactured both from Sanquin Plasma
and ViroPharma Plasma

 

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Appendix 2 – Fees

 

A. Purchase Price

The Purchase Price for the ViroPharma Product (manufactured on the basis of
Sanquin Plasma) consists of (i) a base fee and (ii) a royalty on net sales, as
set out below:

(i) Base fee: €*** per Vial

The base fee shall be adjusted *** on ***, starting on ***, on the basis of the
adjustment of the *** according to the following formula: ***.

(ii) Royalty on net sales of ViroPharma Product (manufactured on the basis of
Sanquin Plasma) in the ViroPharma Territory: ***%

 

B. Manufacturing Fee

The Manufacturing Fee for having Sanquin toll manufacture the ViroPharma Product
(on the basis of ViroPharma Plasma) consists of (i) a base fee and (ii) a
royalty on net sales, as set out below:

(i) Base fee: €*** per Vial

The base fee shall be adjusted *** on ***, starting on ***, on the basis of the
adjustment of the *** according to the following formula: ***.

(ii) Royalty on net sales ViroPharma Product (manufactured on the basis of
ViroPharma Plasma) in the ViroPharma Territory: ***%

 

C. Determination royalty on net sales

The royalty component of the Purchase Price and the Manufacturing Fee payable by
ViroPharma to Sanquin shall be determined as follows:

 

1. Each year ultimately on January 31 ViroPharma shall send to Sanquin a report
on the total net sales of ViroPharma Product in the ViroPharma Territory in the
preceding calendar year, specifying the sales volumes and net sales prices per
country, it being understood that such net sales will be determined on the basis
of US GAAP.

 

2. Within *** Business Days upon receipt of any such report as referred to in 1
Sanquin may notify ViroPharma whether it wishes to dispute the number of net
sales in the report. Such notification shall include the reasons for such
dispute in reasonable detail. If no notification is sent within such period or
if the Parties otherwise agree on the number of net sales, such number shall be
final.

 

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3. If a notification as referred to in 2 is received by ViroPharma the Parties
shall endeavor to agree on the number of the net sales within *** Business Days
of the submission of such notification to ViroPharma.

 

4. If the Parties will not have agreed in writing on the number of net sales,
within the *** Business Day period referred to in 3, the Parties shall appoint
an independent accountant (onafhankelijke registeraccountant) of a firm of
international repute (the “Expert”) to determine the net sales in a final and
binding resolution (bindend advies).

 

5. Failing agreement on the Expert between the Parties before the expiry of that
*** Business Day period, the Expert shall be appointed within *** Business Days
after the expiry of such period by the President of the Royal Institute of
Chartered Accountants (Koninklijke Nivra) on written request of either of the
Parties.

 

6. The Expert shall as soon as possible thereafter, but in any event within ***
Business Days of his appointment, notify the Parties of his decision on the
determination of the net sales.

 

7. Any *** payable to the Expert shall be *** the Parties. The *** shall be
borne by the Parties in such proportion as the Expert shall, in his decision,
determine to be reasonable.

 

D. Assumptions Purchase Price/Manufacturing Fee

Concerning the Purchase Price and the Manufacturing Fee the following applies:

 

1. it is assumed that a Vial contains 500 Units;

 

2. the ViroPharma Product shall be delivered by Sanquin to ViroPharma without
official batch release, or similar approval, by any Governmental Authority;

 

3. the ViroPharma Product shall be supplied as filled and freeze-dried product
in Vials which are individually labeled (using normal labeling, not including
any rfid’s (radio frequency id’s) or similar devices in the label) and packed in
an individual box in accordance with Applicable Law, containing water for
injection, transfer needles and infusion sets, as the case may be; and

 

4. the individually packed Vials shall be grouped together in boxes made out of
material that is sufficiently sturdy to avoid damage of the Vials or exposure of
the ViroPharma Product to temperatures exceeding the specified limits under
normal shipment conditions.

 

E. Batch release fee

The batch release fee amounts to €*** per batch.

 

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The batch release fee shall be adjusted *** on ***, starting on ***, on the
basis of the adjustment of the *** according to the following formula: ***

 

F. ViroPharma Plasma Handling Services fee

The fee for the Handling Services amounts to €*** per kg of ViroPharma Plasma
delivered by ViroPharma to Sanquin (independent of whether or not such
ViroPharma Plasma is used for toll manufacturing of ViroPharma Product by
Sanquin).

The fee for the Handling Services shall be adjusted *** on ***, starting on ***,
on the basis of the adjustment of the *** according to the *** according to the
following formula: ***.

 

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Appendix 3 – Sanquin Early Stage Research Programs

First listing of existing Sanquin Early Stage Research Programs to be completed
before March 31, ***

 

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Appendix 4 – Determination net sales

 

1. Each time within a period of one (1) month upon expiry of a Reference Year,
ViroPharma shall send to Sanquin a report on the total net sales of ViroPharma
Product in the ViroPharma Territory in such Reference Year, specifying the sales
volumes and net sales prices per country, it being understood that such net
sales shall be determined in accordance with US GAAP.

 

2. Within *** Business Days upon receipt of any such report as referred to in 1
Sanquin may notify ViroPharma whether it wishes to dispute the number of net
sales in the report. Such notification shall include the reasons for such
dispute in reasonable detail. If no notification is sent within such period or
if the Parties otherwise agree on the number of net sales, such number shall be
final.

 

3. If a notification as referred to in 2 is received by ViroPharma the Parties
shall endeavor to agree on the number of the net sales in the Reference Year
concerned within *** Business Days of the submission of such notification to
ViroPharma.

 

4. If the Parties will not have agreed in writing on the number of net sales,
within the *** Business Day period referred to in 3, the Parties shall appoint
an Expert (as defined in Appendix 2 under paragraph C) to determine the net
sales in a final and binding resolution (bindend advies).

 

5. Failing agreement on the Expert between the Parties before the expiry of that
*** Business Day period, the Expert shall be appointed within *** Business Days
after the expiry of such period by the President of the Royal Institute of
Chartered Accountants (Koninklijke Nivra) on written request of either of the
Parties.

 

6. The Expert shall as soon as possible thereafter, but in any event ***
Business Days of his appointment, notify the Parties of his decision on the
determination of the net sales.

 

7. Any *** payable to the Expert shall be *** the Parties. The *** shall be
borne by the Parties in such proportion as the Expert shall, in his decision,
determine to be reasonable.

 

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