Contract for cooperation development of rh-Interferonα-2a project
Contract
for cooperation
development of rh-Interferonα-2a
project
Project
Name:
The
research and development of recombinant human Interferon α-2a
(rh-IFNα-2a)
from
yeast system
Party
A:
Shanghai Wanxing Bio-pharmaceutical Company
Party
B:
Fudan
University
Project
Target:
Using
the technology of rh-IFNα-2a
project from Fudan University, finish the medium-size manufacture and all the
pre-clinical studies, apply and acquire formal approval for the clinical trials
of rh-IFNα-2a.
Project
Development Schedule:
|
1.
|
Before
the end of October, 1997: finish the preparations of medium-size
manufacture of rh-IFNα-2a.
|
|
a.
|
Set
up laboratory which can be used for biological activity assay of
rh-IFNα-2a.
Each day, 205 samples can be assayed stably.
|
|
b.
|
Finish
the equipments preparations for medium-size manufacture, including
fermentation, purification steps and etc.
|
|
c.
|
Finish
the human resource and manufacture field preparations for medium-size
manufacture of rh-IFNα-2a.
|
These
tasks shall be done by Party A under the assisting of Party B.
|
2.
|
From
Nov., 1997 to the end of Jan., 1998: produce three batches of
rh-IFNα-2a
products at the medium-size manufacture. It shall be finished by
the
cooperation of Party A and Party B.
|
|
3.
|
From
Feb., 1998 to the end of Mar., 1998: finish the quality self-control
of
rh-IFNα-2a
and send the samples to the official institute for the quality review.
Finish
the necessary animal trials. All the documents shall be ready for
the
clinical trials application.
|
| These tasks shall be done by Party A under the assisting of Party B. The materials for animal trials shall be offered mostly by Party A. |
The
expenses for the project research and development and the way to pay
Party
A
shall pay Party B 0.5 million RMB as compensation
for the research and development of rh-IFNα-2a
project at previous stage. The first part, 0.3 million shall be paid when the
contract is signed by both Parties. The second part, 0.2 million shall be paid
at the end of Mar., 1998.
The
expenses for the cooperation stage shall be paid by Party A according to the
need of the project. When the product is on the market, Party B shall share
the
benefit with Party A. The sum that Party A shall pay Party B is 3% of the sales
amount. The beneficial term is 15 years.
The
belongings of the equipments and materials for the project
development
The
equipments, materials and documents bought by the compensation money from Party
A belong to Party B. The equipments, materials and documents bought by Party
A
for the cooperation research and development of the project belong to Party
A.
Confidentiality
Both
Party A and Party B shall keep the information of rh-IFNα-2a
project confidential. It is not allowed to let out to the third Party without
both side agreements.
The
responsibility for the risk
If
the
project fails due to unconquerable technical difficulties, the responsibility
shall be taken by both sides. It shall be solved by both side negotiations.
Ownership
of the project results
The
project results from the previous stage are owned by Party B. The issued patents
from this project shall be shared by both sides. The non patent results also
are
also shared by both sides, but Party A holds the dominant position.
Breach
of the contract and the compensation for the loss
Due
to
some reasons, the cooperation project has to be terminated, Party A still need
pay Party B all compensation expenses for the previous stage
studies.
Arbitration
The
dispute shall be solved by both side negotiations. If the dispute can not be
solved by both side negotiations, it shall be submitted to Shanghai Arbitration
Commission.
Validity
This
contract is valid when it is signed by Party A and Party and the term for the
validity of this contract is from Oct. 01, 1997 to Sep. 30, 2013.
Party
A:
Shanghai Wanxing Bio-pharmaceutical Company
Date:
Sep. 26, 1997
Party
B:
Fudan University
Date:
Sep. 26, 1997
