EXHIBIT 10.9
[LETTERHEAD OF XXXXX PHARMA INCORPORATED]
CONTRACT MANUFACTURING AGREEMENT
This agreement is intended to define the responsibilities, mutually agreed to,
by GenTrac, Inc., 0000 Xxxxxxxxx Xxxx, Xxxxxxxxx, XX 00000 and Fusion Medical
Technologies, Inc., 0000 Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000 regarding the
manufacture of topical thrombin, Thrombin-JMI(R).
1. GenTrac, Inc. agrees to manufacture Thrombin-JMI(R) in compliance with US
License #977 and applicable CGMPs
2. All distribution of Thrombin-JMI(R) will be performed by Xxxxx Pharma
Incorporated, St. Louis, MO, in compliance with agreements between Fusion
Medical Technologies and Xxxxx Medical Industries, Inc.
3. Each lot of thrombin sold to Fusion Medical Technologies, Inc. will be
accompanied by a certificate of analysis. The certificate of analysis will
contain at least the following Information: Name of product, lot number, date
of manufacture, Thrombin activity, pH, moisture, sterility, general animal
safety per 21CFR610.11, a statement verifying compliance of: cGMPs and
specifications approved in US License #977, as well as verification that raw
material was taken from BSE-free animals of U.S. origin (refer to Attachment
A for an example of the Certificate of Analysis). Each lot of Thrombin must
meet the specifications on Attachment B.
4. GenTrac, Inc. will notify Fusion Medical Technologies, Inc. in writing of
important proposed changes made to the manufacturing process of facilities
which may have an impact on the final product purchased by Fusion Medical
Technologies, Inc.
5. GenTrac, Inc. will allow GMP audits to be performed by approved
representatives of Fusion Medical Technologies, Inc. Such approval shall not
be unreasonably with held. Specific information regarding the process for the
harvesting, activation and purification of the thrombin are not included in
the scope of the audit.
6. Inquiries as to the specific details of manufacture for technical information
regarding Thrombin-JMI(R) shall be directed to the Regulatory Affairs
Specialist of GenTrac, Inc.
Page 1 of 2
7. Fusion Medical Technologies, Inc. agrees to handle, store and distribute the
Thrombin-JMI(R) in a manner consistent with the conditions stated on the
product labeling and the conditions stated in Fusion's submission(s) to the
Food and Drug Administration and/or foreign regulatory agency.
8. This contract manufacturing agreement can be terminated by either party upon
180 day written notification. This agreement was entered into on this day of
September 28, 1998.
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Accepted: Accepted:
Name: /s/ Xxx Xxxxxx Name: /s/ Xxxxxx Xxxxx
---------------------------- --------------------------
Title: V.P. QA & RA Title: V.P. RA & QA
---------------------------- --------------------------
GenTrac, Inc. Fusion Medical Technologies, Inc.
0000 Xxxxxxxxx Xxxx 0000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000 Xxxxxxxx Xxxx, XX 00000
Page 2 of 2
ATTACHMENT A
CERTIFICATE OF ANALYSIS
Thrombin, Topical (Bovine) USP
THROMBIN-JMI(R)
Lot: XXXX
Date of Manufacture: Month XX, XXXX
Thrombin Activity, U.S. Units/vial XXXX
pH -- reconstituted with isotonic saline X.XX
Moisture X.XX
Sterility Sterile
General Animal Safety per 21CFR610.11 Conforms
This lot was manufactured in compliance with cGMPs following the procedures and
specifications approved in U.S. License #977. The bovine plasma and lungs used
to manufacture Thrombin-JMI(R) are taken from BSE-free animals of U.S. origin.
Bovine plasma and lungs used to manufacture this lot of Thrombin-JMI(R) are
derived from inspected animals, which are fit for human consumption and meet all
required USDA specifications.
---------------------------------
Quality Assurance
GenTrac, Inc.
The data contained in this certificate of analysis is representative of the
batch at the time of manufacture. Certificates of Analysis are authorized to
clients on a confidential basis. No reference to the data contained in the
certificate of Analysis may be made public without our written authorization.
GenTrac, Inc. is a subsidiary of Xxxxx Pharma Incorporated, St. Louis, MO.
Thrombin-JMI is a trademark of Xxxxx Pharma Incorporated.
ATTACHMENT B
Specifications for Thrombin, Topical (Bovine Origin), USP
Thrombin-JMI
With 5mL Saline Diluent and Transfer Needle
Parameter Specification How Documented
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Thrombin Activity, US NLT 8,000 US units/vial Vendor Certificate
units/vial
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pH (reconstituted with 5.5-7.5 Vendor Certificate
isotonic saline)
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Moisture (less than or equal to)3.0% Vendor Certificate
------------------------------------------------------------------------------------------
Sterility Sterile Vendor Certificate
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General Animal Safety per Conforms Vendor Certificate
21CFR610.11
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BSE Contamination Verify that plasma and Vendor Certificate
lungs were taken from
BSE-free animals of US
Origin
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