Exhibit 10.3
EXCLUSIVE LICENSING AGREEMENT
BETWEEN:
NCPC GeneTech Biotechnology Co., Ltd.
No. 000 Xxxxxxx Xxxxxx, National High Tech Industry
Development Zone
Shijiazhuang, Hebei
China (Hereinafter referred to as "GeneTech")
AND:
Sino Pharmaceuticals Corporation
Xxxx 000, 00000 Xxxxx Xxxx,
Xxxxxxxxx, X.X. X0X 0X0
Xxxxxx (Hereinafter referred to as "Sino")
WHEREAS GeneTech is a manufacturer, in China, of recombinant Erythropoetin
(r-EPO), a biotechnology pharmaceutical, in both bulk drug and finished
formulation forms, using its own proprietary technology, and,
WHEREAS Sino is an established pharmaceuticals and nutraceuticals company
involved in the sales, marketing and distribution of pharmaceuticals and bulk
and formulated nutraceuticals in North America and Europe, and,
WHEREAS GeneTech is interested in selling its bulk drug r-EPO in Canada and
United States of America (USA) and Mexico, and
WHEREAS Sino is interested in exclusively purchasing, importing, marketing and
distributing GeneTech's r-EPO in Canada, USA and Mexico.
THEREFORE, in consideration of the above the aforementioned parties hereby enter
into this Agreement and hereby agree as follows:
1. "r-EPO" under this Agreement refers to the product produced by GeneTech's
present technology which has been approved by the State Drug Administration
of China.
2. That GeneTech shall exclusively license its bulk drug r-EPO to Sino for
exclusive importation, sales, marketing and distribution in Canada, USA and
Mexico.
3. That Sino shall exclusively purchase, import, sell, market and distribute
GeneTech's bulk drug r-EPO in Canada, USA and Mexico..
4. That GeneTech shall sell and supply its bulk drug r-EPO exclusively to
Sino, as its sole, exclusive licensee and agent in Canada, USA and Mexico.
5. That, in consideration of this exclusive license and sole agency, Sino
shall organize and prepare all the necessary groundwork required for
regulatory approval, registration and legal importation of GeneTech's bulk
drug r-EPO in Canada, and thereafter in USA and Mexico.
6. That the first step in this regulatory approval process shall be the
validation of GeneTech's Drug Master File (DMF) for this product in an
FDA/HPB approved laboratory in Canada. Sino shall provide GeneTech a
document list and specification relating to the product r-EPO as well as
the description of the forms and contents that are necessary for the DMF
validation procedure after entering into this Agreement. GeneTech shall
prepare the documents under the complete and necessary technical guidance
from Sino, in order to meet the DMF validation guidelines.
7. That, to initiate and facilitate this process (in Item 5 above), GeneTech
shall provide Sino with a complete and acceptable DMF (two copies), in
English, and all necessary product samples required for the DMF validation
procedure and other regulatory approvals, free of cost to Sino.
8. That, upon receipt of this complete and acceptable DMF and necessary
product sameples, Sino shall proceed with the DMF validation work in North
America. Sino shall inform GeneTech, from time to time, of the progress of
this validation work. Sino shall accomplish the DMF validation procedure
and registration in a reasonable period that both parties agree after
receiving GeneTech's DMF and necessary products samples. If Sino cannot
accomplish the above works in the above period, both parties shall discuss
to prolong this period to another reasonable period. If Sino still cannot
accomplish the above works in the reasonable period, both parties shall
discuss to terminate this Agreement.
9. That, upon successful validation of the DMF, Sino shall proceed with all
the other regulatory requirements in Canada, USA and Mexico, as that it can
achieve regulatory approval and commence with purchases, legal importation,
sales and distribution of GeneTech's bulk drug r-EPO in Canada, USA and
Mexico.
10. That all costs incurred in North America in validating the DMF and
obtaining regulatory approvals, for legal importation and sales of
GeneTech's bulk drug r-EPO in Canada, USA and Mexico shall be borne by
Sino, whereas all costs incurred in China shall be borne by GeneTech.
11. That, upon Sino's receipt of regulatory approval in North America and its
commencement of purchases and importation of GeneTech's bulk drug r-EPO,
GeneTech shall supply Sino with its products, as per the specifications and
analysis contained in the DMF (GeneTech to supply specifications).
12. That GeneTech shall guarantee and maintain its quality (as per the DMF) for
every shipment and batch supplied and sold to Sino.
13. That GeneTech shall guarantee to supply Sino with all its bulk drug r-EPO
at a reasonable market price, to be mutually agreed between both parties.
Both parties shall discuss and determine annual supplying and sales plans
according to the market, and have obligations to accomplish the agreed
plans. If on party cannot fulfill its obligations in two successive years,
both parties shall discuss to revise or terminate this Agreement.
14. Sino shall have the full right to sell and market GeneTech's bulk drug
r-EPO, in Canada USA and Mexico, under Sino's own brand and trademarks.
Sino shall agree that it shall show the name of the product origin,
GeneTech, on the packing materials if necessary. Sino shall agree that it
only purchases GeneTech's bulk drug r-EPO instead of other suppliers in
China.
15. GeneTech shall not, directly and indirectly on purpse, allow its bulk drug
r-EPO to be registered in Canada, USA and Mexico by any other party, or
supply its bulk drug r-EPO to any other party in Canada, USA and Mexico,
under this Agreement. However, this clause shall only apply to the bulk
drug r-EPO defined in the DMF under this Agreement.
16. This Agreement shall be subject to standard Force Majeur clauses, as per
the current International Chamber of Commerce (ICC) Force Majeur clauses.
17. If, for any reason, any party to this Agreement fails to comply with any of
the terms and conditions of this Agreement, or fails to [perform its
obligation under this Agreement, then both parties shall try to resolve any
disputes amicably. However, if amicable settlement or resolution is not
possible, then both parties agree to enter into arbitration, which
arbitration shall be held at the International Arbitration Center in
Vancouver, Canada. The results of such arbitration shall be held final and
binding on both parties.
18. The validity of this Agreement shall be for a period of five years from the
date of signing thereof.
19. This Agreement shall be governed and interpreted under the laws of Hong
Kong, China.
The parties to this Agreement hereby lend their signatures on December 4, 2002.
This Agreement is made out in English in duplicate and each Party shall hold one
copy.
For, and on behalf of, For, and on behalf of,
NCPC GENETECH SINO PHARMACEUTICALS CORP.
BIOTECHNOLOGY CO., LTD.
By:/s/__________________ By: /s/_________________
Xx Xxx Chuan Xxxxxxx X. Xxxx
Title: Chairman & President Title: President & CEO
