Exhibit 10.5
PROJECT ASSIGNMENT 2
PROTALEX, Inc.
717 Encino Pl. NE, Suite 17
Albuquerque NM 87102
USA
Date: July 31st, 2003
Dear Sirs,
Agreement between PROTALEX Inc. ("PROTALEX") and EUROGENTEC S.A ("EUROGENTEC")
dated April 24, 2003 (date of the signature of the R&D Projects Frame Contract).
This letter shall constitute a Project Assignment for the purposes of the above
Agreement ("the Agreement"). We agree that EUROGENTEC will perform a Project
under the Agreement on the following terms:
1. Description of the Project
Upon PROTALEX' s request, EUROGENTEC Project Assignment 1 has demonstrated the
feasibility to produce and purify Protein A from Staphylococcus aureus A-676
strain fermentation. In the course of the feasibility, fermentation and DSP
(Down Stream Process) has been partly studied. The goal of this Project
Assignment is to develop Fermentation, DSP, QC tests in order to set-up
procedures and parameters for future Protein A GMP Manufacturing. The
development programme will encompass the following steps:
- Analysis of batch 03G17 according to hereunder PROTALEX specifications:
Bioburden : no organisms detected.
Endotoxin : <0.5 EU/mg
Enterotoxin B : <1 mcg/mg
SDS-PAGE : > 98%
HPLC : >98% at 214 nm >95% at 280 nm
Hu IgG binding : >95%
UV absorbance : E (0.1%, 276 nm) = 0.14-2.0
Isoelectric Focusing: Single band between 4.6 and 5.2
- QC Development and Qualification (SDS-PAGE, Western Blot, HPLC, Bioanalyzer,
BCA, bioburden, enterotoxin B, Hu IgG Binding, IEF,etc.)
- 2 fermentations at 50-L scale to fine-tune the parameters defined during the
Feasibility.
- Kinetic analysis of fermentors
- Definition of the fermentation conditions for scale-up and Robustness Study
- Down Stream Process : 3 DSP runs at 10-L scale from Fermentor # 1
- Definition of the DSP steps and conditions
- DSP on fermentor # 2 at 50-L scale
- QC analysis (ELISA, Western Blot, SDS-PAGE, BCA, HPLC)
2. Time-Lines and Completion date of work Starting date has to be considered 2
weeks after reception of (i) signed Frame Contract , (ii) signed hereunder
Project Assignment and/or (iii) the first PROTALEX payment as defined in the
paragraph 6.
Based on a starting date September 1st,2003 Development programme and QC/IPC
development should not length more than 2.5 months until mid-November, 2003.
The tentative Calendar (page 4) may not be considered as a firm commitment from
EUROGENTEC.
3. Quantities and specifications of product to be supplied to PROTALEX The
material produced and purified during this study will be delivered to PROTALEX.
Quantity and Purity of Protein A will be related to the production of the
protein during the Fermentation process and to the performances obtained during
the DSP steps.
4. Eurogentec Staff The R&D Fermentation will be performed under the
responsibility of Ir. Xxxxxxx Xxxxxxxxx, Head of R&D Fermentation. Xxxxx Xxxxxx
X.Xx. DSP Team Leader, will be in charge of the Down Stream Process for the
Feasibility Phase of the Purification Process. Xxxxxx Xxxxx X.Xx. QC Manager,
will supervise the QC first developments.
5. Project Management]
Xxxxxxx Xxxxxx will make the overall project management.
6. Fees and Terms of payment
Expected duration Cost in euro
QC/In Process Controls
(Fermentation, DSP,
2.5 months euro 75,000 (fixed cost)
Development Programme 2.5 months euro 39,375/month
The overall Project management is charged euro 2.000 /month from the start
of the Project until the completion of the Project.
The total cost of the Development Programme is evaluated at euro 178,437.5:
euro 173,437.5 for the study and euro 5,000 for the project management.
50 % (euro 89,219) of the total cost will be invoiced at the signature of the
Frame
Contract/Project Assignment 1. PROTALEX shall pay EUROGENTEC at the receipt of
the invoice.
25 % (euro 44,609) of the total cost will be invoiced after one month. Invoice
shall be paid within thirty days of receipt.
the last invoice representing the remaining 25% ( euro 44,609) of the total
price will then be issued at the completion of the project ( November
2003). Invoice shall be paid within thirty days of receipt.
Normal laboratory reagent costs are included in the cost of the Development
Study. However specific costs, such as chromatographic media,
ultrafiltration membranes, DNA Sequence Analysis (outsourced) will be
charged separately with 5% overhead. Costs will need to be approved by
PROTALEX prior to commitment or purchase.
7. Documentation and Reports
The Development Study will be recorded in specific laboratory notebooks with
double signature. They will be kept at EUROGENTEC for 10 years. Copies can be
made available to PROTALEX. Intermediary reports will be issued after main step
completion. Laboratory books will be in French, reports in English.
The final report will give full description of the process and the yields of
product obtained. Details of any analytical methods used will also be included.
8. PROTALEX Deliverables
No PROTALEX deliverables is expected to be provided to EUROGENTEC.
EUROGENTEC S.A.
____________________ ______________________
Name: Xxxxxxx Xxxxxx Name: Xxxxxx Xxxxx
Title: Project Manager Title: Biologic Business Unit Manager
Date: August 29, 2003 Date: August 29, 2003
EUROGENTEC S.A. o Parc scientifique du Sart Tilman o 0000 XXXXXXX x XXXXXXX o
Tel.: x00 0 000 00 00 Fax: x00 0 000 00 00 o e-mail: xxxx@xxxxxxxxxx.xxx o R.C.
Liege 152 016 o T.V.A. BE 427 348 346
PROTALEX Inc.
____________________ ______________________
Name: Xxxxxx Xxx, Ph.D. Name: Xxxxxx Xxxx
Xxxxxx: Chief Scientific Officer Title: CEO
Date: August 28, 2003 Date: August 28, 2003
