Exhibit 10.28
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PURCHASE AND
SERVICE
AGREEMENT
___________________________________________________________________
between
Shanxi Weiqida
Pharmaceutical Co. Ltd.
and
Shanxi Qianyuan
Pharmaceutical Co. Ltd.
July 28,
2006
1
PURCHASE
AND SERVICE AGREEMENT
This Agreement is
made on July 28, 2006
By and
between
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1.
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Shanxi Weiqida Pharmaceutical
Co., Ltd., a company established and existing in accordance with
the laws of the People’s Republic of China
(“PRC”), having its registered office at No. 15
Gongnong Road, Datong, Shanxi Province, the PRC (hereinafter
referred to as “Party A”)
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2.
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Shanxi Qianyuan Pharmaceutial
Co., Ltd., a company established and existing in accordance with
the laws of the People’s Republic of China
(“PRC”), having its registered office at Datong City
Economic and Technology Development Zone (hereinafter referred to
as “Party B”); and
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(Each of the
parties is referred to individually as a “Party” and
collectively as the “the Parties”.)
Whereas:
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1.
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By and through the assets
purchase agreement executed on June 29, 2006 between Party A and
Party B (“Assets Purchase Agreement”), Party B takes
over from Party A assets for formulation business including those
related to the Active Pharmaceutical Ingredient named Fostomycin
Trometamol Salt (the “Product”), the quality of which
meet the standard of European Pharmacopoeia.
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2.
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Together with Dragon
Pharmaceutical (Canada) Inc., (Dragon Canada), an a affiliate of
Party A, C&Y Pharmaceutical Investment Holdings Limited
(C&Y), the parent company of Party B, the two parties signed a
Purchase and Service Agreement on June 29, 2006, both parties, with
the consent from involving affiliates, agreed to replace which by
this agreement hereby signed.
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3.
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Party A has appointed Explora
Laboratories SA (“Explora”), a Swiss company, as its
agent to distribute the Product in Italy and other European
countries (the “Territory”) and to apply for all
necessary approvals and certificates for the Product to enter into
the Territory.
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4.
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Party A recognized the
registration documentation made by Party A as qualified and
acceptable for the registration and agreed to purchase that based
on the present achievements.
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5.
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Party A agrees to allow Party
B to use the documentation for the registration in other
territories and, with the assistance of its associated company, to
provide services for international registration for the Products to
Party B during the term of this agreement.
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Now and therefore,
on the basis of being equal and out of their own willingness, Party
A and Party B agree as follows:
2
Appointment
As Party A has
already rendered a majority part of the services described in
Article 2.1 hereof, Party A hereby appoints Party B and Party B
hereby accepts Party A’s appointment to continuously render
such services to Party B for the term of this Agreement.
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2.1
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The Parties acknowledge that,
prior to the execution of the Agreement, Party A has already
rendered by and through such of Party A's officers, employees,
agents, representatives and affiliates, 90% of the services in
relation to entrance of the Product into the Territory (the
"Services"), including without limitation the following types of
services:-
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collected information based
on the requirements of GMP questionnaire and translated all
relevant documents;
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instructed COA modification
according to Explora’s comments and added solvent tests in
the COA;
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translated specifications and
analytical methods;
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arranged samples of
intermediates to be sent to Explora for the study of
impurity;
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collected production process
information and rewrote and translated process
narratives;
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identified critical steps and
intermediates and translated into English;
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collected and translated all
specifications and analytical methods for starting materials,
solvents, reagents, filter aids etc.;
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translated synthesis
description, flow chart and certificate of analysis for key
starting materials;
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arranged intermediate of a
key starting material to be sent to Explora for synthesis of
impurity D;
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contacted PAPP supplier in
Italy for the primacy packaging information and made modification
for the container closure system according to Explora’s
comments and translated all related documents;
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discussed the stability
issues with Explora for final solution and ensured implementation
of the packaging system in their stability test; and
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conducted all the
correspondences with Explora for better understanding and
explanation and pushed the project forward.
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2.2
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During the term of this
Agreement, Party A shall continuously render to Party B, by and
through such of its officers, employees, agents, representatives
and affiliates, the Services necessarily required for the entrance
of the Product into the Territory.
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3
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2.3
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During the term of this
agreement, Party A allows Party B to use the registration document
achievements sold to Party B for the registration and sales of
other territories, and Party A shall continuously render to Party
B, by and through such of it's officers, employees, agents,
representatives and affiliates, the Services necessarily required
for the entrance of the Product into those territories.
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2.4
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Before provision of each type
of Services, at the request of Party B, the Parties shall
comm
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