REGISTRATION AGENCY CONTRACT ON PRODUCTS
MED-ANGIN AND MED-BRONCHOL
CONTRACT NO.: BMP/ Klosterfrau 20050622a
PARTY A: MCM Klosterfrau Klosterfrau GmbH(Hereinafter referred to as
"KLOSTERFRAU")
Address: Xxxxxxxxxxxxxxxxxxx 0-00
X-00000 Xxxx; Xxxxxxx
PARTY B: Beijing Med-Pharma Co., Ltd.
(Hereinafter referred to as "MED-PHARM")
Address: Room 2001, Capital Mansion, 0, Xxxxxxx Xxxxx Xxxx;
Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000, Xxxxx
WHEREAS:
- Party A intends to register Med-angin and Med-bronchol in Chinese relevant
administrations so that the products can be marketed in China.
- Med-Pharm provides professional agency services including registrations
and clinical trials of medical products for foreign pharmaceutical
companies. The company is able to assist Party A in applying for
registration of Products such as Med-angin and Med-bronchol in China.
THEREFORE:
In order to register Products of Med-angin and Med-bronchol in the State Food
and Drug Administration (SFDA) as soon as possible, the two parties, after
friendly and serious negotiation, have entered into the following agreement.
ARTICLE 1. NAME OF THE PROJECT AND COOPERATIVE AIM
1.1 Name: Application for registration of Products of Med-angin and
Med-bronchol in SFDA
1.2 Aim: Party A hereby appoints party B as its consultant for the purpose of
assisting Part A in obtaining "IMPORT DRUG LICENSE " for Products of
Med-angin and Med-bronchol by the end of 2008.
ARTICLE 2. RIGHTS AND OBLIGATIONS OF PARTY A
2.1 To offer "Power of Attorney on Product Registrations" to Party B;
2.2 To preliminarily clear up all technical materials and samples of the
registered products and offer them to Party B as soon as possible
according to "Materials on Import Biological Products Application" by
request of SFDA;
2.3 To cooperate with Party B actively and to offer required information
include but not limited to supplementary documents, medicine packages and
showpieces of labels in respect of information and advice provided by
Party B and the instructions of SFDA;
2.4 To pay on time for the proceeding of the registration in order that
registrations
can go smoothly. The details are stipulated in appendix 1;
2.5 If SFDA requires visit and examine KLOSTERFRAU manufacture in Germany, the
expenditure should be borne by Party A;
2.6 Party B should not be responsible for the failure of the registrations if
party A refuses to follow the provisions of SFDA and tests of product
quality and clinical efficacy are not in accordance with the standards and
requests of SFDA;
ARTICLE 3. RIGHTS AND OBLIGATIONS OF PARTY B
3.1 To start working upon receiving the first payment;
3.2 To provide list of the materials and documents required by registration
application to Party A and to approach the relevant evaluation experts for
professional opinion or to organize "product registration appraisal
meeting" in time after receiving the above-mentioned materials so that the
application can go smoothly;
3.3 To translate and clear up all materials and submit them to involved
administrations following the instructions of SFDA;
3.4 To keep in touch with examining section and evaluation experts related to
SFDA in different phases of application, and to coordinate different
relations actively and to track and urge the registration;
3.5 To inform Party A of the development of the registration and relevant
information periodically;
3.6 The registration is carried on phase and the fees are paid accordingly.
The paid-up money will not be refunded.
ARTICLE 4. SECURITY ARTICLES
The two parties are obliged to keep secret all relevant information, technique
documents, business secrecy and know-how got from the other. Each should never
use them or disclose them to third parties without the other's authorization.
ARTICLE 5. TERM OF THIS AGREEMENT
This agreement will be terminated automatically with the achievement of the
captioned registrations and Party A's pay-off.
ARTICLE 6. LIABILITY FOR BREACH
This agreement will govern the relationship between the two parties as long as
the two parties come to it. Each should not modify or terminate it without
notifying the other. The party, who breaches the clauses of this contract,
should pay the other 30 percent of all disburse as compensation for such breach.
ARTICLE 7. APPLICABLE LAW
This contract should be governed by PRC's law.
ARTICLE 8. SETTLEMENT OF DISPUTES
Matters concerned and unsettled shall be settled through friendly negotiations
between the parties. The proceedings, on which the parties come to an agreement,
shall be
confirmed in the form of memorandum. As attachment to this contract, this
memorandum is an inseparable part of the contract and equal to the contract in
legal effect. If the dispute cannot be settled through negotiations, the dispute
shall be submitted to CIETAC which shall make a final decision in accordance
with the arbitral rules thereof.
This contract has four copies and each party has two. This contract shall
come into effect on the date when the authorized representative of each of the
parties of the parties signs on it.
SUBSCRIBERS OF CONTRACT
PARTY A: MCM Klosterfrau Klosterfrau GmbH
Signature and Seal:
/s/ Xx. Xxxxx Xxxxxx
Xxxxxxxxx Xxxxxxxx ppa. Xx. Xxxxx Xxxxxx
Date: 7/19/05 /s/ Xxxxxxxxx Xxxxxxxx MCM Klosterfrau GmbH & Co
Koln-Mitte
PARTY B: Beijing Med-Pharm Co., Ltd. (Seal) Gereonsmithlengasse 1-11
50670 Koln
Signature and Seal: [ILLEGIBLE] Brief: Postfach 10 21 55
50461 Koln
Date: 7/11/05
[SEAL]
CONTRACT NO.: BMP/ KLOSTERFRAU 20050622a
CHANGE OF APPENDIX 1
Appendix 1 of the contract Nr. 20050622a was changed after mutual approval and
replaces Appendix 1 of the contract signed 19.07.2005. This changing of the
Appendix 1 comes into force after signature of both parties.
MCM Klosterfrau Klosterfrau GmbH Beijing Med-Pharm Co., Ltd.
Signature and Seal Signature and Seal
/s/ Xx. Xxxxx Xxxxxx /s/ [ILLEGIBLE]
-------------------- --------------------------
ppa. Xx. Xxxxx Xxxxxx
Date: 9/12/05 Date 2005.09.20
MCM Klosterfrau GmbH & CO
Koln-Mitte
Xxxxxxxxxxxxxxxxxxx 0-00
00000 Xxxx
Brief: Postfach 10 21 55
50461 Koln
APPENDIX I : CHARGE STANDARD AND MANNER OF PAYMENT
PARTY A: MCM Klosterfrau Klosterfrau GmbH
(Hereinafter referred to as "KLOSTERFRAU")
Address: Xxxxxxxxxxxxxxxxxxx 0-00
X-00000 Xxxx; Xxxxxxx
PARTY B: Beijing Med-Pharm Co., Ltd.
(Hereinafter referred to as "MED-PHARM")
Address; Room 2001, Capital Mansion; 0, Xxxxxxx Xxxxx Xxxx;
Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000; Xxxxx
ITEM NAME: Products of Med-angin and Med-bronchol Registration Agency
CONTRACT NO.: BMW/Klosterfrau 20050622a
CONTRACTING DATE: 19.07.2005/Changed: 12.09.2005
CHARGE STANDARD:
In consideration for the services provided under this Contract, Part B shall get
the aggregate fixed sum of USD One Hundred and Twenty Thousand ($120000)("Fee"),
The fees don't include SFDA's officers and the evaluation experts' travel and
visit to the manufacture in Germany. The fees shall be paid as follows:
MONEY
ITEM Unit: US$ PAYMENT TIME
-------------------------------- --------- ----------------------------------------------------
Registration Project Med- 35,000 $ Party A should pay in a week after contracting
angin and Med-bronchol 35,000 $ Party A should pay in a week after submission
Expenditure of the application to SFDA
30,000 $ Party A should pay in a week after QC analysis
started
QC analysis 15,000 $ Party A should pay in a week after NICPBP
check and accept product samples
Organizing on clinical trial party A should pay in a week after receiving
"Approval Document for Clinical Trial of Import
Biological Product", the sum of money is about
$220,000.00 including the service charge to Party B
in the ratio of 10% on the total expenditure of
clinical trial on the basis of negotiation with the
SFDA and Chief investigator.
Taking IDL 5,000 $ Party A should pay the final payment in a week after
receiving the certificate of "IMPORT DRUG LICENSE"
IN CHINA For Med-angin and Med-bronchol from Party
B.
SUM TOTAL 120,000 $
