Collaborative Agreement for Development of Genetic Engineering Malaria Vaccine Party A: Shanghai Wanxing Bio-Pharmaceuticals Co. LTD Party B: Second Military Medical University, PLA
Collaborative
Agreement for Development of
Genetic Engineering Malaria Vaccine
Party
A: Shanghai Wanxing Bio-Pharmaceuticals Co. LTD
Party
B: Second Military Medical University, PLA
In
order
to accelerate the developing process of genetic engineering malaria vaccine
and
put it into the clinical use as soon as possible, based on the principles of
equality, Mutual
beneficial and good faith, Party A
and
Party B
entered
into a Cooperative Agreement for Development of Genetic
Engineering Malaria Vaccine.
1.
The Contents and Requirements of the Target Techniques
Party
A
and Party B are likely to collaboratively develop the genetic engineering
malaria vaccine, a national class I new drug with intellectual property owned
by
Party B, to make it entered into the clinical investigation, acquire the new
drug certificate and use it to prevent malaria infection. The transfer fee
of
the project is XXX 00 xxxxxxx.
0.
Xxxxxx technical Endpoints
2.1
Acquire the SFDA’s approval of clinical trials;
2.2
Conduct the clinical trials;
2.3
Acquire the New Drug Certificate;
2.4
Acquire the production Certificate.
3.
Responsibilities
3.1
Party A
3.1.1
To
provide staff and fertilities and establish a stable and feasible pilot-test
process;
3.1.2
To
prepare enough pure antigens for the preclinical research;
3.1.3
To
organize and arrange the preclinical researches designed by both
sides;
3.1.4
To
complete the self-examination of the semi-product and the product, and send
the
product samples to NICPBP for inspection.
3.1.5
Be
responsible for compiling, writing and submitting the application documents
for
clinical research.
3.1.6
Be
responsible for applying the approvals of clinical trials and new drug
certificate.
3.1.7
Be
responsible for organizing, proceeding, coordinating the clinical
trials.
3.1.8
To
pay the installment payments timely to B per the Agreement.
3.2
Party B
3.2.1
After signing the Agreement and receiving the first milestone payment from
Party
A, Party B should provide the engineering strain of malaria vaccine, related
laboratory techniques and methods to Party A for pilot research.
3.2.2
Help Party A to accomplish the necessary laboratory tests and clinical trials
in
accordance to the requirements of application procedures.
3.2.3
Prepare the documents of the construction of the engineering strain and the
documents of the identification of physical and chemical characters of some
proteins for application of clinical trials; participate in the new drug
assessment meeting.
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4.
Research Funding and Payment
4.1
On
the date of signing the Agreement, Party A shall Pay 3 millions RMB for Party
B
which will be used for preclinical research.
4.2
The
expenditures in pilot research, preclinical research clinical trials and the
applications should be paid by Party A except those should be done by Party
B
per the Agreement.
4.3
Party
A shall be responsible for the payment of the sample test fees and other test
fees to NICPBP.
5.
Belongings of the Achievements and the Rights of Both
Sides
Party
A
and Party B will develop the project jointly and will share the fruitful results
together. The new drug certificate will be applied jointly by both sides and
owned by both sides. Party B’s name will be put before Party A’s
name.
5.1 Regarding
the Patent
In
the
event that Party B has filed the patent applications to the patent licensing
authorities, the rights of both the national patent and the international patent
application belong to Party B. After the agreement is signed and become
effective, Party A holds the exclusive right of the patent relating to use
and
preparation of malaria vaccine and will pay the fees to maintain the
effectiveness of the patent. With regard to the application of international
patents, Party A may recommend countries or areas for patent application to
Party B, and Party A should pay the patent applying and maintaining fees. If
the
Agreement is terminated by any reasons during the execution of the agreement,
the exclusive right to exploit the above patent would also be terminated. If
further patent application relating to this patent needs to be submitted in
the
agreement effective period, the related issues should be negotiated by both
parties.
5.2
Regarding
the Payment of the Transfer Fees
When
the
drug certificate is licensed, Party A shall pay Party B 20 millions RMB as
transfer fee of the project, and Party B should transfer it’s ownership of the
certificate to Party A. The transfer fees will be paid as follows:
| l |
The
first part of transfer fee is RMB 10 millions, and will be paid by
party A
to Party B within 5 working days after the New Drug Certificate be
licensed.
|
| l |
The
second part of transfer fee is RMB 5 millions, and will be paid by
Party A
to Party B within 5 working days after the Trial Production Certificate
be
obtained.
|
| l |
The
third part of transfer fee is RMB 5 millions, and will be paid by Party
A
to Party B within 5 working days after the Production Certificate be
obtained.
|
If
the
New Drug Certificate and the Trial Production Certificate are licensed at the
same time, the payment is as follows:
| l |
The
first part of transfer fee is RMB 10 millions, and should be paid by
Party
A to Party B within 5 working days after two certificates are
obtained.
|
| l |
The
second part of transfer fee is RMB 5 millions, and should be paid by
Party
A to Party B within 6 months after two certificates are
obtained.
|
| l |
The
third part of transfer fee is RMB 5 millions, and should be paid by
Party
A to Party B within 5 working days after the Production Certificates
is
obtained.
|
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5.3 After
the
transfer fees have been paid following the above schedule, Party A will hold
the
production and sale rights of this project.
5.4Under
the
same situations, Party A has the priority of cooperating or buying the improved
malaria vaccines further developed by Party B.
5.5The
new
drug research grants and risk investment funds applied by Party A will be spent
by Party A.
5.6
The
funds of this project applied by Party B will be used by Party B
5.7
If
the funds which will be used only in the inner or international clinical trials
are applied mainly by Party B and assisted by Party A, Party A will pay the
clinical trial fees to Party B according to the schedule as agreed before,
but
the total sum will not be over XXX 0 millions. If the sum of international
research funds is less than 4 millions, Party A will pay Party B the actual
money that enters into Party B’ account. If there are still some of the abroad
research funds left when the clinical trials are finished, the left funds will
be used by Party B. The above money will be paid within 5 working days after
the
money enters into Party A’s account.
5.8
The
money listed in items ‘5.5, 5.6 and 5.7’ is not limited by the transfer fee of
the Agreement.
5.9
Party
B has the right to use the research documents for the acceptances and summaries
of the funds.
5.10
Party B will be listed in prior to Party A on the applications of the research
achievements related to this project.
5.11
The
execution of this contract will be terminated spontaneously upon the both
parties have executed their responsibilities written in the sections in this
contract and the Party A has paid all the technical transfer fees.
6.
Confidentiality of the technical data and information
During
the course of this contract, Wanxing and SMMU should not solely disclose the
technical data and information relevant to this project to third party in any
name or in any manner, or transfer this project to third party, or collaborate
with third party to research the malaria vaccine based on this project for
the
profit purposes.
7.
Risk Liability and Breach Liability
7.1
Each
party shall not be responsible to the other collaborative party for failing
of
new drug application due to the force majeure.
7.2
In
the event of insufficient technological performance of Party A, the preclinical
studies and the clinical trials could not be gone ahead normally, this contract
will be terminated immediately just after the confirmation of Shanghai
Arbitration Committee. The transfer tees paid by Party A to Party B will not
reimbursed.
7.3
In
the events that the technical indices could not meet with the applicable
requirements as the scientific and technological causes, either party has no
responsibility on this aspect. Either party will rework the experiments and
then
renew the application. This contract is still effective in the course of
renewing the application till to the success. The cost and expense for the
rework will be resolved by the mutual negotiation.
7.4
If
Party A could not pay for the outlay in due course, or the preclinical studies
or clinical trials could not be conducted normally due to the financial shortage
in the company, this contract will be terminated spontaneously. The transfer
tees paid by Party A to Party B will not reimbursed.
3
7.5
Neither party shall deliberately disclose the information about the “Malarial
Vaccine” strain or the manufacture techniques to third party, or engage in the
benefit activities using the relevant techniques with the third party. If so,
such behavior is regard as breach action.
7.6
During the executive course of the contract, each party has the right to claim
the compensation if the other party has the breach action. The compensation
shall be as large as the contract price if the breach is serious and causing
the
heavy loss.
8.
Dispute and resolution
Any
dispute relating to the execution of this contract shall, unless amicably and
genuinely settled, be subject to conciliation. In the event of failure of the
latter, the dispute shall be settled by the litigation in the corresponding
court of the signature place.
9.
The parties will renegotiate the terms and conditions of this contract to
resolve any inequities.
10.
This contract will be executed in four counterparts, each party shares two
counterparts. The contract shall be in force from the date it has been signed
and stamped by both parties, and Party B receives the first milestone payment
while Party A receives the expressive strain.
Party
A: Shanghai Wanxing Bio-Pharmaceuticals
Representative:
Banjun Yang
Date:
March 22, 2001
Party
B: Second Military Medical University,PLA
Representative:
Xxxxxxx Xxx
Date:
March 22, 2001
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