Exhibit 10.19
Portions redacted
* Certain information on this page has been
omitted and filed separately with the
Securities and Exchange Commission.
Confidential treatment has been requested
with
respect to the omitted portions.
Agent Agreement
THIS AGREEMENT is made as of March 12, 2004
in Suzhou, China
AMONG:
Allwin Biotrade,
Inc., a corporation organized under the laws of
British Virgin Islands with an office at East Asia Chambers,
P.O. Box
901, Road Town, Tortola, British Virgin Islands
("Allwin Biotrade" Or "Agent")
AND:
Jiangsu Wuzhong
Industry Co. Ltd., a corporation Organized under the
laws of the People's
Republic of China with an office at 338,
East
Baodai Road, Wuzhong District, Suzhou, People's Republic of
China.
("Wuzhong")
AND:
Jiangsu Wuzhong Industry Co. Ltd. Suzhou Zhongkai Bio-Pharmaceuticals
Plant, a corporation organized under the laws of the People's
Republic
of China with an office at 5, ChengHu Road, Wuzhong Economic Zone of
Development, SuZhou, People's Republic of China.
("Zhongkai")
("Wuzhong" and "Zhongkai" are collectively hereinafter as
"Licensors")
(Allwin Biotrade are collectively hereinafter as "Agent")
Each party is referred hereinafter as a
"Party", or "collectively as "Parties")
WHEREAS:
A. Licensor owns certain
proprietary
rights and license to
use, sell or
market a cytokine
commonly know as Recombinant Human Granulocyte
Colony
Stimulating Factor
("rhG-CSF"
or "Product") in People's
Republic of China ("PRC")
B. Agent possesses the expertise and experience in working with its
Licensees
internationally to
register and market certain biotech
products outside of China.
Initial: /s/
Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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<PAGE>
C. Licensor and Agent had signed a Letter of
Intent on October 17,
2003
to confirm the Parties' intention to enter into an agreement under
which Agent would be the exclusive agent to market Licensors'
rhG-CSF
and other agreed upon products for all indications in certain
countries and territories outside of China.
THIS AGREEMENT WITNESSES that in consideration of $1 paid and other
consideration given, by each party to each other party, the, receipt and
sufficiency of which each party
acknowledges,
the parties
severally AGREE as
follows:
Article 1. DEFINITIONS AND
INTERPRETATION
1.1 In this Agreement, except as
otherwise expressly provided or as the context
otherwise requires:
1.1.1
"Product" means purified, quality-controlled Recombinant Human
Granulocyte Colony
Stimulating
Factor, in bulk or finished
dosages manufactured by Licensors;
1.1.2
"Affiliate" of a
party means a corporation or entity that,
directly or indirectly, controls, is under common control with
or
is controlled by the specified party;
1.1.3
"Arrival Airport" means the closest international airport to the
shipping address specified in each Purchase Order.
1.1.4
"FOB" shall
have the meaning set forth in the International
Chamber of Commerce document, "Incoterms 2000".
1.1.5
"Current GMP" means
current good manufacturing practices as
determined by the World Health Organization;
1.1.6
Departure Airport"
means any of the major airports in the
People's Republic of China, including but not limited to
airports
in Beijing, Shanghai and Nanjing;
1.1.7
"Drug Master
File" or "DMFI" means any and all information,
process, techniques
and data in
Allwin Biotrade's possession
relating to the
Product as far as
required to obtain Product
Approval.
1.1.8
"Market Area" means
the territory or
territories
described in
Schedule B;
1.1.9
"Indication" means the
use of the Product to treat a particular
condition as described in Schedule B;
1.1.10
"Marketing
Plan" has the meaning set out in ss.3.1;
1.1.11
"Parties"
means both of the
parties hereto collectively; and
"Party," depending upon context, shall mean either of them.
1.1.12
"Registration Dossiers" means any and all information,
processes,
techniques, and
data in Agent's possession relating to the
Finished Products as far as required to obtain Product
Approval.
1.1.13
"Licensee"
means any entity to which Agent grants sub-licenses of
the Product under Agent's rights specified in this Agreement.
Initial: /s/
Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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<PAGE>
1.2 In this Agreement, except as
otherwise expressly provided or as the context
otherwise requires,
1.2.1
"this Agreement"
means this agreement as from time to time
supplemented or
amended by one or more
agreements entered
into
pursuant to the applicable provisions of this Agreement,
1.2.2
a
reference to a Part is to a Part of this
Agreement,
and the
symbol ss. followed by
a number or some
combination of
numbers
and letters
refers to the section, paragraph, subparagraph,
clause or sub-clause of this Agreement so designated,
1.2.3
headings are solely
for convenience
or reference and are not
intended to be complete or accurate descriptions of content or
to
be guides to interpretation of this Agreement or any part of
it,
1.2.4
the
word "including", when following a general statement or term,
is not to be construed as limiting the general statement or term
to any specific item
or matter set forth or to similar items or
matters, but rather as
permitting the general
statement or term
to refer also to all other items or matters that could
reasonably
fall within its broadest possible scope,
1.2.5
an
accounting term not
otherwise defined
herein has the meaning
assigned to it,
1.2.6
a
reference to a statute includes all regulations made
there-under, all
amendments
to the statute or
regulations
in
force from time to time, and every statute or regulation that
supplements or supersedes such statute or regulations,
1.2.7
a
reference to an entity includes any successor to that entity,
1.2.8
a
word importing the masculine gender includes the feminine and
neuter, a word
in the singular includes the plural, a word
importing a corporate
entity includes an
individual,
and vice
versa ,and
1.2.9
a
reference to
"approval",
"authorization" or
"consent" means
written approval, authorization or consent.
Article 2. GRANT OF
LICENSE
License
2.1 Subject to the terms of this
Agreement, Licensors
hereby appoint Agent
to
be the exclusive agent and distributor to market the Product and Finished
Product from Licensors in the Market Area
as specified in Schedule B. To clarify
further, in such Market Area described in Schedule B, Licensors shall not
appoint any other agents or distributors, or grant any licensing or
sub-licensing rights of Products or Finished
Products, or sell the Product or
Finished Products directly or indirectly in the
Market Area without the Agent.
Meanwhile, Agent is not permitted to own an agent right or to distribute
Recombinant Human Granulocyte.
Colony Stimulating Factor for any other
rhG-CSF manufacturers in China
2.2 [Omitted Intentionally]
2.3 Nothing in this Agreement
confers on Agent any
interest, license or
right
in respect of Product, other than as set
out herein, and the Product will remain
the exclusive property of the
Licensors.
Initial: /s/
Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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<PAGE>
Sales of the Product outside of the Market
Area are prohibited
unless agreed by
Licensors and Agent will have no
manufacturing rights of the Product.
Agent's Regulatory Obligations
2.4 Agent will be responsible for
marketing and arranging licensing agreement
with any potential customers or Licensees to enable
the Sale of the Product in
the Marker Area. In particular, Agent
will
2.4.1
Initiate and
engage in discussion and negotiate with any
potential
customers or
Licensees to enter into licensing
agreements to obtain
registration
and to sell and
market the
Product in the Market Area.
2.4.2
Assist Licensors,
at Licensors' own expense as specified in
Schedule D, in meeting
the documentation requirements in the
Market Area to enable
the Licensees
to submit the
appropriate
documentation to all
applicable
regulatory
authorities in the
Market Area.
2.4.3
Liaise with Licensees and follow up on the registration process
to make sure the
Licensees will use all
reasonable
efforts to
receive the: product
approval in the Market Area in the shortest
possible time.
2.4.4
Assist Licensors in
obtaining quotes and estimates from contract
service organizations
in the United
States of America
and the
European Union to undertake the testing to be performed.
2.4.5
Assist, if necessary,
Licensors to liaise with the United States
Department of
Agriculture
to obtain permits for Licensors to
export the tested
articles to a contract
service organization
based in the United States.
2.5 Licensors will use their best
efforts together with
Agent and Licensees to
generate documentation in obtaining the
Product Approval, including providing to
Agent and Licensees
2.5.1
the
open part of the Drug Master File (`"DMF"): Product will be
described in a DMF of which Agent and Licensees wilt receive the
open part and
Licensors will
supply the closed part
of the DMF
directly to the applicable regulatory authorities of the Market
Area. To clarify further, Agent or Licensees may not have
access
to the
closed part of the DMF.
2.5.2
any
necessary information
concerning the Product
in the case of
any question from the
applicable regulatory
authorities in the
Market Area
2.5.3
reasonable amounts
of the Product, at the cost of Licensors,
necessary for Agent or
Licensees to conduct such research or
clinical testing
required to be completed in order to obtain the
Product Approval.
2.5.4
access to the production facility, upon reasonable notice from
the Agent, for the
audit by applicable
regulatory
authorities
and/or Licensees of the Market Area.
Notwithstanding the foregoing, nothing will obligate Licensors or any of its
Affiliates to conduct any research
activities
or clinical
trials in order
for
Agent or Licensees to obtain the Product
Approval except that Licensors agree to
perform at its own expense; (i) biosafety testing and
characterization
of its
e.coli cell line master cell bank; (ii)
biosafety testing and
characterization
of end-or-passage cells (cells at the limit of in
vitro life), (iii)
bioburden
testing of samples of at least three batches of raw supernatant and (iv)
validation of viral clearance in the
downstream purification process.
Initial: /s/
Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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<PAGE>
Licensor shall be responsible for
completing all of the validations,
verifications and characteristics required
for a regulatory approval for
rhG-CSF; Licensor shall be responsible for
compliance to international
pharmaceutical-biotechnological
manufacturing GMP guidelines.
Sublicenses
2.6 Agent has sublicensing right to grant sublicenses granted under this
Agreement to appoint other entities as Licensees for the
purpose of selling and
marketing the Product within the Market
Area. Agent should provide a copy of all
sublicensing agreements signed between Agent
and Licenses to Licensor within 15
days of signing of such agreements provided that such disclosure is not in
violation of the confidentiality agreed
between Agent and Licensees.
Article 3. MARKETING
Marketing Plan
3.1 Agent and Licensors will jointly
develop a marketing
plan (the
"Marketing
Plan") for the sale of the Product in the
Market Area.
The initial Marketing
Plan, which covers the following l2
Month period, will be
prepared within
120
days after signing of this Agreement and an
update of such Marketing Plan with a
rolling l2-month forecast will be done every three months thereafter. The
Marketing Plan will be reviewed quarterly by representatives of Agent and
Licensors.
Article 4. PRICING, ORDERS
AND PAYMENT
"See Schedule
A"
4.1 Notwithstanding any change in the
Product pricing set out in Schedule A, no
price change will affect the price of any
Product for which a purchase Order has
been issued and accepted.
4.2 All Product pricing set out in Schedule A are
on a FOB basis. The
Arrival
Airport will be specified in each Purchase
Order.
4.3 Prices for Product are
exclusive of customs fees and exercise and sales
taxes in the importing country,
and other taxes in the
importing country in the
nature of a sales tax, now existing or hereinafter imposed by national
authorities or those of any political subdivision thereof upon the sale of
Product by Licensors to Agent. In the event any such fee or tax
is imposed on,
or assessed against, Licensors as a result of the sale
and delivery of Product
hereunder, Licensors shall separately itemize such fees and taxes on the
applicable invoices and Agent shall pay the
appropriately invoiced amount within
60 days after receiving such invoices from
Licensor.
Purchase Orders
4.4 Agent will prepare purchase orders
("Purchase Orders")
for all Product and
each such order will specify the
quantity of Product
and any other
information
that either party considers necessary.
Purchase Orders cannot be amended without
the consent of Licensors.
4.5 Licensors willl acknowledge receipt of all Purchase Orders by a
facsimile/e-mail sent within five (5) business days after receipt of the
Purchase Order.
Initial: /s/
Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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<PAGE>
Delivery Times
4.6 Licensors will promptly fill all Purchase
Orders received from Agent in
accordance with the terms of each
Purchase Order. If Licensors are able to
deliver the Product in a shorter
period of time than
specified in the
Purchase
Order, it will notify Agent of such earlier
delivery date.
4.7 Notwithstanding ss.4.8, if Licensors for any reason can not meet the
delivery times in a Purchase Order, it will notify Agent of the expected
delivery date when it confirms the Purchase
Order under ss.4.7.
Upon receipt of
Licensor's notice of the expected delivery
date, Agent may, on notice delivered
to Licensors within five (5) business days of Agent' receipt of Licensor's
confirmation of the Purchase Order,
withdraw the Purchase Order. If the Purchase
Order is not withdrawn, the delivery times in ss.4.8 will be deemed to be
amended to the time set out in Licensors
confirmation
of the Purchase Order.
Payment
4.8 Within the first year of business
operation (1 year from
the date of first
purchase order), the payment by Agent will be made
by Letter of Credit (L/C) at
60 days after shipment.
4.9 Other means of payment could be
discussed after that period.
Title and Risk
4.10 All Product pricing is on a FOB basis.
Title to the
Product and risk
of
toss or damage shall pass to the Licensees
when such Product is
delivered onto
the carrier at the Departure Airport.
Audit Right
4.11 Licensors will keep clear and accurate
books; and records of all sales of
Finished Products in the Market
Area. Up to twice a year, at the request and
expense of Agents, and upon at least five days prior
written notice,
Licensors
will p
