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 Xxxxxxxx, 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 000, Xxxx
Xxxxxx Xxxx, Xxxxxxx Xxxxxxxx, 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 0, XxxxxXx Xxxx, Xxxxxxx 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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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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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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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 xxxx 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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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
5
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 permit Agent to review the books and sales records of the Market Area
during regular business hours.
Additional Procedures
4.12 The parties recognize that additional procedures related to the purchase
and shipment of Product may be necessary from time to time during the term of
this Agreement and each will cooperate with the other to formulate and implement
new policies and procedures.
Article 5. MANUFACTURING
Specifications
5.1 Licensor will produce all Product conforming to specifications laid down in
Schedule B and in accordance with current GMPs in effect at the time of
manufacturing. All changes planned for the production of the product will have
to be announced to Agent before implementation.
Shipping
5.2 Licensors will ensure that each shipment conforms to the Purchase Order and
all Product will be packaged and shipped to the Arrival Airport as specified in
each Purchase Order in accordance with the requirement for maintenance at
2(degree)C -8(degree)C cold chain during shipment. To permit the proper tracking
of the Product, the air waybill number will be transmitted to Agent as soon as
practicable after shipment of the Product.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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Testing of Product
5.3 Agent, through Licensees or itself may arrange for the Product to be tested
at Agent's laboratory or at an independent third party facility to determine
whether the efficacy or purity of the Product is within manufacturing
specifications as provided for in the Product Approval. Agent will promptly
notify Licensors of such test results once received.
5.4 Licensors or its Affiliates will provide the standard testing method of the
Product to Agent.
5.5 If the testing conducted under ss.5.4 determines that the Product fails to
meet the standards of efficacy or purity required under the terms of the Product
Approval, Agent will be entitled to receive, at the Agent's choice, a refund of
the purchase price as specified in the Purchase Order or a replacement shipment
of the Product. Notwithstanding the foregoing, Licensors may, before providing a
refund or replacement Product, conduct testing at an independent third party
facility in the Market Area of the Product shipment. If the result of
Licensors's testing indicates that the Product does meet the standards set out
in the Product Approval, Licensors and Agent will use good faith efforts to
resolve the discrepancy in the test results and make a determination as to the
suitability of the shipment for sale.
Article 6. CONFIDENTIALITY AND NON-COMPETITION
Confidentiality
6.1 During the term of the Agreement, and for a period of one (1) years
following the expiration or earlier termination hereof, each Party shall
exercise reasonable care to maintain in confidence all information of the other
Party disclosed by the other Party and identified as, or acknowledged to be,
confidential ("Confidential Information"), and shall not use, disclose or grant
the use of Confidential Information except on a need-to-know basis to those
directors, officers, employees and permitted assignees, to the extent such
disclosure is reasonably necessary in connection with such Party's activities as
provided in the Agreement. Prior to disclosure, each Party hereto shall obtain
the written agreement of any such Person, who is not otherwise bound by
fiduciary obligations to such Party to hold in confidence and not make use of
the Confidential Information for any purpose other than those permitted by the
Agreement. Each Party shall notify the other promptly upon discovery of any
unauthorized use or disclosure of the other Party's Confidential Information.
Permitted Disclosures
6.2 The non-use and non-disclosure obligations contained in this article shall
not apply to the extent that (a) any receiving Party ("the Recipient") is
required (i) to disclose information by law, order or regulation of an
administrative agency or a court of competent jurisdiction, or (ii) to disclose
information to any administrative agency for purposes of obtaining approval to
manufacture, test or market a product, provided in either case that the
Recipient shall provide written notice thereof to the other Party and sufficient
opportunity to object, time permitting, to any such disclosure or to request
confidential treatment thereof; or (b) the Recipient can demonstrate that (i)
the information was public knowledge, other than as a result disclosure to the
Recipient by the other Party hereunder; (iii) the information was disclosed to
the Recipient on an unrestricted basis from a third party not under a duty of
confidentiality to the other Party; or (iv) the information was independently
developed by employees of the Recipient without access to Confidential
Information of the other Party.
Return Of Confidential Information Upon Termination
6.3 Upon termination of this Agreement, each Party shall promptly return to the
other, at the other's request, any and all Confidential Information of the other
then in its possession or under its control except if such information is
covered under surviving rights.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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Article 7. DISPUTE RESOLUTION
Disputes
7.1 If at any time there is a dispute among the parties with respect to any
matter relating to this Agreement, any party that wishes the issue to be
considered further will give notice to the other of that it requires the dispute
to be decided under the terms of this Agreement.
Referral to Senior Officers
7.2 If a notice is given under ss.7.1, a senior officer designated by each
party will undertake discussions for the purpose of settling the dispute. A
decision reached by these officers and communicated in writing to the parties
will be determinative of the dispute and will be binding on each party.
Arbitration
7.3 If no decision is reached under ss.7.2 within 30 days of the dispute being
sent for consideration, either party may, by notice to the other party given at
any time before a decision is rendered under ss.7.2, submit the dispute (or
determination by a single arbitrator acting under Hong Kong International
Arbitration Centre.
7.4 The arbitration will take place in Hong Kong and will be administered by
the Hong Kong International Arbitration Centre and conducted in accordance with
the procedures of the centre.
Article 8. TERM AND TERMINATION
Term
8.1 This Agreement will be in effect for a ten-year period and will be renewed
automatically for successive two-year terms unless other\vise terminated in
accordance with the terms hereof (the "Term").
Termination by Either Party
8.2 Either party may terminate this Agreement
8.2.1 upon notice given at least 180 days before the end of the current
Term, such termination to come into effect at the end of that
Term, or
8.2.2 Immediately upon written notice if the other party
8.2.2.1 is in breach or violates any of the terms and conditions of
or fails to perform any of its obligations under this
Agreement and, after receiving notice from the other party,
does not cure such default within 45 days, or
8.2.2.2 becomes insolvent, bankrupt, makes an assignment for the
benefit of its creditors or has a receiver,
receiver/manager, trustee or liquidator appointed in respect
of its business or its assets.
Liabilities
8.3 Upon termination of this Agreement, Licensors will be required to complete
any and all existing Purchase Orders as at the date of termination and Agent or
Licensees will be required to receive and pay for all Products shipped in
connection with such Purchase Orders.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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Article 9. LIABILITIES AND INDEMNIFICATION
Indeminification
9.1 Licensors will indemnify, hold harmless and defend Agent, its officers,
employees, Licensees and agents against any all claims, suits, losses, damages,
costs) fees, and expenses resulting from or arising out of exercise of the
rights granted under the definitive Agreement, the proper use of the Product or
Finished Product and the sale of the Product or Finished Product under the label
and indications. Zhongkai will not be held responsible for the Product or
Finished Product being used off label and out of the indications as specified in
Schedule B or wrongly handled during transportation or storage at Agent's or
Licensees' premises. Agent shall ensure that Licensor is promptly notified of
any such claims in which it intends to invoke this Article 9. Agent and its
employees shall cooperate fully with Licensor and its legal representatives in
the investigation and defense of any action) claim or liability covered by this
indemnification.
Insurance
9.2 Licensors, at its sole cost and expense, will insure its activities in
connection with the work under this Agreement and obtain, keep in force, and
maintain insurance or an equivalent program of self insurance.
Article 10. GENERAL PROVISIONS
Entire Agreement
10.1 This Agreement constitutes the entire agreement between the parties and
supersedes every previous agreement, communication, negotiation, representation
or understanding, whether oral or written, expressed or implied, between the
parties with respect to the subject matter of this Agreement.
10.2 No director, officer, employee or agent of any party has any authority to
make any representation or commitment not contained in this Agreement and each
party has executed this Agreement without reliance upon any such representation
or commitment.
Force Majeure
10.3 No party will be liable for its failure to perform any of its obligations
under this Agreement as a result of Acts of God (including all natural
disasters), strikes, lockouts, civil disturbances, government or court ordered
interruptions or delays, acts of war and riots, but that either Party to this
Agreement may elect to terminate it upon three months written notice to the
other if force majeure cannot or is not remedied within three months after its
occurrence.
Severability
10.4 If any provision of this Agreement is at any time unenforceable or invalid
for any reason it will be severable from the remainder of this Agreement and
this Agreement will be construed as though such provision was not contained
herein and the remainder will continue in full force and effect and be construed
as if this Agreement had been executed without the invalid or unenforceable
provision.
Amendments
10.5 This Agreement may not be amended except in writing signed by both parties.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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Assignment
10.6 Neither party will be entitled to assign this Agreement without the written
consent of the other party, which consent cannot be unreasonably withheld.
Governing Law
10.7 This Agreement is and will be deemed to have been made in Suzhou, China for
all purposes will be governed exclusively by and construed and enforced in
accordance with the laws prevailing in Hong Kong and the rights and remedies of
the parties will be determined in accordance with those laws.
Attornment
10.8 Each of the parties irrevocably attorns to the Hong Kong International
Arbitration Center and all courts having appellate jurisdiction thereover.
Notice
10.9 To be effective, a notice, request, demand or direction (each for the
purposes of this provision a "notice") to be given pursuant to this Agreement by
one party to another party must be in writing and must be
10.9.1 delivered by hand or by mail, or
10.9.2 received by telecopy transmission or other similar form of
written communication by electronic means,
in each case addressed as applicable as follows:
If to Agent at:
East Asia Xxxxxxxx
P.O. Box 901
Road Town Tortola
British Virgin Island
Attention: Mr. Xxxxx Xxxxxx III or appointed person
Fax: + 0-000-000-0000
with a copy to such other offices or Agent as may be specified
by Agent to Licensors;
If to Licensors at:
Jiangsu Wuzhong Industry Co. Ltd.
Suzhou Zhongkai Bio-Pharmaceuticals Plant
at 0, XxxxxXx Xxxx, Xxxxxxx Economic Zone of Development.
SuZhou, People's Republic of China.215128
Attention: Xx. Xxxxx Shenzheng or The person appointed
Fax: +86-512w65620523
or to such other address or fax number as is specified by the addressee by
notice to the other party.
10.10 A notice delivered or sent in accordance with ss.10.9 will be deemed to
be given and received
10.10.1 at 8.00 a.m. on the day of delivery or receipt at the place of
delivery or receipt if that day is a Business Day at that place
and the delivery or receipt is before that time on that day)
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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10.10.2 at the time of delivery or receipt if received on or after 8.00
a.m. and before 4.00 p.m. at the place of delivery or receipt on
a day that is a Business Day at that place, and
10.10.3 at 8.00 a.m. at the place of delivery or receipt on the next day
that is a Business Day at that place, if delivered or received on
a day that is not a Business Day at that place or at or after
4.00 p.m. at that place.
No Partnership
10.11 Nothing in this Agreement will constitute, by any means, a partnership
between Licensors AND Agent or Licensees.
Binding Effect
10.12 This Agreement will ensure to the benefit of and be binding upon the
respective successors and permitted assigns of the parties.
Further Assurances
10.13 Each Party will carry out its corresponding responsibilities and
rights in order to execute this Agreement. For unforeseen expenses that may
occur in the future, both Parties agree to negotiate in good faith.
Survival
10.14 The obligations under Section 6, 7, 8, 9 and 10 shall survive the
termination of this Agreement.
Counterparts
10.15 This Agreement will be signed in English and Chinese, both of them
should be identical and with the same effect. Should there appear differences of
interpretation then, the English version will supersede the Chinese version.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
11
IN WITNESS WHEREOF this Agreement was executed by the parties as of the day and
year first above written.
Allwin Biotrade, Inc. Witnessed by:
Per: /s/ Xxxxxxxxx Xxxx Per: /s/ Xxxxx Xxxxxx
--------------------------- -----------------------------
Jiangsu Wuzhong Industry Co. Ltd. Witnessed by:
Per: /s/ Xxx Xxxxxxx Per: /s/ Xxxxx Xxxx
--------------------------- ----------------------------
Jiangsu Wuzhong Industry Co.,Ltd.
Suzhou Zhongkai Bio-Pharmaceuticals Plant Witnessed by:
Per: /s/ Zhong Shenzheng Per: /s/ Xxxxx Xxxx
----------------------------- ----------------------------
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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SCHEDULE A
The following table lists out the price which will be in effect until one year
after the date of first purchase order (FOB China)
--------------------------------------------------------------------------------
Number of Vials Vial Size
75 ug 150 ug 300 ug
USD USD USD
< 10,000 * * * * * * * * *
10,001 - 50,000 * * * * * * * * *
50,001 - 100,000 * * * * * * * * *
10,001 - 200,000 * * * * * * * * *
> 200,000 * * * * * * * * *
--------------------------------------------------------------------------------
* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED
WITH THE COMMISSION.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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SCHEDULE B
Product: JIEXIN
Granulocyte Colony Stimulating Factor ("GCSF") for injection.
Market Area:
REGION - Africa.
COUNTRY
Angola, Benin, Burkina Fasco, Cameroon, Central African, Chad, Xxxx Verde,
Congo, Ethiopia, Gabon, Ghana, Guinea Conakry, Guinea-Bissau, Ivory-Coast,
Kenya, Madagascar, Mali, Mauritania, Mozambique, Namibia. Nigeria. S. Tome and
Principe, Senegal, South Africa, Sudan, Tanzania, Togo, Uganda, Zaire, Zambia,
Zimbabwe
REGION -Asia.
COUNTRY
Bangladesh, Xxxxx, Burma. East Timor; India, Indonesia, Laos, Malaysia,
Mauritius, Myanmar, North Korea, Pakistan, Philippines, Singapore, South Korea,
Sri Lanka. Taiwan, Thailand
REGION -Eastern Europe
COUNTRY
Albania, Armenia, Azerbaijan, Bulgaria, Byelorussia, Croatia, Czech Republic,
Estonia, Georgia, Hungary, Kazakhstan, Kirgizstan, Kosovo, Latvia, Lithuania.
Macedonia. Moldova, Monogolia, Poland, Romania. Russia, Serbia, Slovakia,
Slovenia, Ukraine, Uzbekistan
REGION -Western Europe
COUNTRY
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Xxxxxxx,
Xxxxx, Xxxxxxxxxx, Xxxxx, Xxxxxxxxxxx. Norway, Portugal, Spain, Sweden,
Switzerland, United Kingdom
REGION -Latin America
COUNTRY
Argentina, Aruba, Barbados, Belize, Bolivia, Brazil, Chile, Colombia, Costa.
Rica., Cuba, Dominican Republic, Ecuador, EI Salvador, French Guyana, Guatemala,
Guyana, Haiti, Honduras, Jamaica, Martinique, Mexico, Nicaragua, Panama,
Paraguay, Peru, Salvador, Surinam, Trinidad-Tobago, Uruguay, Venezuela
REGION -Middle East & North Africa
COUNTRY
Algeria, Egypt, Eritrea, Gulf States, Iran, Iraq, ,Jordan, Lebanon, Libya,
Morocco, Oman, Palestine, Syria, Tunisia, Turkey, Yemen
REGION -North America
COUNTRY
Canada, United States
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
00
XXXXXX -Xxxxx Xxxxxxx
XXXXXXX
Xxxxxxxxx, Xxx Xxxxxxx
*Remark: Supposed there is no any sales results happened in the above listed
regions and countries within 3 years after signing the agreement, then these
areas will not be included.
Indications:
Cancer Patients Receiving Myelosuppressive Chemotherapy
GCSF is indicated to decrease the incidence of infection, as manifested by
febrile neutropenia, in patient with nonmyeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a significant incidence of
severe neutropenia with fever.
Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation
Chemotherapy
GCSF is indicated for reducing the time to neutrophil recovery and the duration
of fever following induction or consolidation chemotherapy treatment of adults
with AML.
Cancer Patients Receiving Bone Marrow Transplant
GCSF is indicated to reduce the duration of neutropenia and neutropenia-related
clinical sequelae, e.g. febrile: neutropenia, in patients with nonmyeloid
malignancies undergoing myeloablative chemotherapy followed by marrow
transplantation.
Patient Undergoing Peripheral Bood Progenitor Cell Collection and Therapy
GSCF is indicated for the mobilization of hematopoietic progenitor cells into
the peripheral blood for collection by leukapheresis.
Patients With Severe Chronic Neutropenia
GSCF is indicated for chronic administration to reduce the incidence and
duration of sequelae of neutropenia (e.g. fever, infections; oropharyngeal
ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia,
or idiopathic neutropenia.
Also, and any other indications approved in the Market Area at the time of
Product Approval or subsequently thereafter.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
15
SCHEDULE C
Costs and Responsibilities:
------------------------------------------------------------------------------------------------------
Description Responsibility Payments
------------------------------------------------------------------------------------------------------
Manufacturing and analysis of Licensors Licensors*
Product or Finished Product
(rhG-CSF)
------------------------------------------------------------------------------------------------------
Preparation of shipment, packaging Licensors Licensors*
------------------------------------------------------------------------------------------------------
Shipment using air-mail Licensors Licensors or Agent and Licensees *
------------------------------------------------------------------------------------------------------
Preparation of Customs documents Licensors Licensors*
------------------------------------------------------------------------------------------------------
Customs clearance in China Licensors Licensors.
------------------------------------------------------------------------------------------------------
Customs clearance in Arrival Airport Licensees Licensees
------------------------------------------------------------------------------------------------------
Receipt from custom-house Licensees Licensees
------------------------------------------------------------------------------------------------------
Quality analysis of the product in
company, Licensor should receive the
analysis report within 20 business Agent or Licensees Agent or Licensees
days, otherwise, the products were
deemed to be qualified.
------------------------------------------------------------------------------------------------------
Analysis in independent laboratory Agent or Licensees If, in opinion of the independent
in the case of quality not laboratory, the quality is good-
complying with requirements and Agent. if not - Licensors
payments connected with such an
analysis
------------------------------------------------------------------------------------------------------
Checking analysis in another Licensors Licensors
laboratory
------------------------------------------------------------------------------------------------------
Packaging and labeling Licensees Licensees
------------------------------------------------------------------------------------------------------
Sales and distribution Agent or Licensees Agent or Licensees
------------------------------------------------------------------------------------------------------
*- Included in the price of the Product.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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SCHEDULE D
Licensors Documentation Expenses
Licensors will be billed at a price of USD$* * *.
* * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED
WITH THE COMMISSION.
Initial: /s/ Zhong /s/ AW
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CONFIDENTIAL INFORMATION
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