Raw Plasma Supply Agreement (Summary Translation) December 30, 2005 Raw Plasma Supply Agreement Party A: Shandong Missile Biologic Products Co. Ltd. Party B: Shandong Province Qihe Plasma Collection Station
EXHIBIT
10.4
(Summary
Translation)
December
30, 2005
Party
A:
Shandong Missile Biologic Products Co. Ltd.
Party
B:
Shandong Province Qihe Plasma Collection Station
According
to item 13 of the Regulation “Controlling of Blood Products”, a plasma
collection station may only supply raw plasma to one blood products manufacturer
under quality credential agreement, raw plasma supply to other manufacturers
is
forbidden. According to MOH standards, the plasma collection station and blood
products manufacturer must sign an agreement for the supply of raw
plasma.
According
to plasma regulations promulgated by the Bureau of Health, Shandong Province,
Party B shall supply Party A with source plasma (hereafter referred to as
“plasma”). Both parties agree to the following terms and
conditions:
1.
Quantity and Quality Standards of Plasma Supply
I.
Party
B shall provide Party A with plasma collected from donors within the collection
area who have passed all physical and biochemical tests.
II.
Major
quality standards are as follows:
| (1) |
HBsAg
negative;
|
| (2) |
Anti-HCV
negative;
|
| (3) |
Anti-HIV
negative;
|
| (4) |
ALT
≤ 25 units (Reit’s method);
|
| (5) |
Syphilis
serological test negative;
|
| (6) |
Total
plasma protein ≥ 55g/L (Biuret
method);
|
| (7) |
No
germ contamination;
|
| (8) |
Compliance
with all other standards promulgated by the MOH over raw
plasma;
|
| (9) |
Appearance:
plasma should be rice-yellow, clear, transparent liquid, without
dissolved
blood, milky feculence, fibrinogen clots, visible red blood cells
or other
impurities.
|
III.
The
testing reagents used for HBsAg, Anti-HCV, Anti-HIV and syphilis testing must
have passed “every-batch” inspection, and labeled with counterfeit-proof
labels.
IV.
If
the plasma sample fails to pass the double test performed by Party A, Party
A
shall immediately notify Party B to send technical personnel for further
testing. If the sample fails to pass further testing, then the unit (bag of
plasma) is disqualified, and Party A shall not make any payment. Party A should
notify Party B of any testing failure in writing on a timely basis. The
disqualified plasma should be sterilized on the spot and disposed of
immediately, and Party A shall not dispose of disqualified plasma privately
or
send the plasma back to Party B.
2.
Labeling Plasma Samples
I.
Every
bag of plasma should be labeled with the name, collection code, blood type,
physical and biochemical test results of the donor, as well as the collection
date.
II.
Every
shipment of plasma should include a xxxx of lading, providing information on:
the number of donors, the number of bags of plasma, as well as the biochemical
test results. All these information should be internally
consistent.
III.
Each
bag of plasma must be appended with enough sample (about 13cm of conducting
tube), labeled with the corresponding plasma collection code. The sample plasma
must be consistent with the plasma contained in the bag. Plasma with sample
label absent, unclarity or lacking of code or inconsistency with records is
treated as disqualified, plasma would be disposed of in the way described in
1(IV).
IV.
Collection coding: continual coding within the same year from January 1 to
December 31, without repeating or skipping. Codes take the form of
“03000001-03015551”, with “03” representing the year 2003, and 000001-015551
specifying plasma man collection unit. Thus the number of collections taken
in
the year 2003 was 15551.
3.
Pricing and Transportation
I.
The
pricing of plasma complies with regulations promulgated by the provincial Bureau
of Health and the provincial Pricing Bureau. The current unit price of qualified
plasma is RMB $235,000 per ton, balance settled at the end of every month.
If
national plasma pricing standards should shift, both parties shall negotiate
on
new prices.
II.
If
the protein level of the plasma is lower than 55g/L, the price is reduced by
2%
for every 1g/L lower than the standard. The protein level here referred to
is
the average protein level of the annual supply, calculated at the end of each
year.
III.
Party A is responsible for the transportation of plasma. Party B shall pack
the
plasma and load the transporting vehicles as Party A requires. After all
relevant personnel have confirmed the information in the xxxx of lading,
delegates of both parties shall sign to certify delivery.
IV.
Party
A visits Party B to collect plasma and make payment on a regular basis. Payment
for each batch of plasma are made at the delivery of the next
batch.
4.
Other
Specifications
I.
The
plasma collected must be stored in freezing temperature by each donar. No cross
mixing of plasma should occur.
II.
After
collection, the plasma should be immediately stored in a fridge or cold storage
room at -30℃, to ensure freezing within 6 hours.
III.
Each
bag contains 580ml of plasma, or equivalent to 600 g in weight. The net weight
of each bag of plasma is calculated in the following way: gross weight - bag
weight - sample tube weight ≈ net weight.
IV.
Party
B may only supply plasma to Party A. No supplying to any third party should
take
place.
V.
Party
A is obliged to offer complete technical guidance to Party B and ensure quality
control.
5.
Any
details not specified in this Agreement shall be negotiated between both
parties.
6.
There
are five copies of this Agreement: one held by either party, and one submitted
to the provincial, municipal and county Bureau of Health,
respectively.
7.
This
Agreement becomes valid after legal delegates of both parties have signed and
stamped. The agreement will end on December 31, 2006.
Party
A
Legal
Delegate: (signature and stamp)
January
1, 2006
Party
B
Legal
Delegate: (signature and stamp)
January
1, 2006
