STUDY CONTRACT between ImVisioN GmbH, Prof. Dr. Horst Rose Feodor-Lynen-Strasse 5, 30625 Hannover/Germany _____________________________________________________ ___________________________________________ (in the following referred to as the Client)...
RCC
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EXHIBIT 10.21
RCC Ltd.
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STUDY CONTRACT
between
ImVisioN GmbH, Prof. Xx. Xxxxx Xxxx
Xxxxxx-Xxxxx-Xxxxxxx 0, 00000 Xxxxxxxx/Xxxxxxx
________________________________________________________________________________________________
(in
the following referred to as the Client)
Contact Person: Prof. Xx. Xxxxxx X. Xxxxxxxx, tpi Consult GmbH, Seelze / Germany
and
RCC Ltd, CH-4452 ltingen/BL,
Switzerland
________________________________________________________________________________________________
(in
the following referred to as the RCC)
Contact Person for this Contract at RCC: Xx. Xxx Xxxxxxxx
RCC Study Number: A99270 of October 18, 2006
Test item name: IVN 201
The contracted studies will (where applicable) be carried out in accordance with the respective guidelines and in conformity with the principles for “Good Laboratory Practices” (GLP).
RCC
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Contracted Studies
The Client herewith commissions the following studies to RCC.
RCC Study Number A99270
57-day Toxicity Study, intranodal, mouse, Pharmaceuticals
Scientific Contact: Xx. Xxx Xxxxxxxx
Study Outline
Number of animals | 80 mice,4 groups of 10/10 for toxicity testing |
40 mice,4 groups of 5/5 for immunotoxicity testing | |
50 mice, group 4 with 19/19 mice and group 1 with 6/6 mice for | |
toxicokinetics/exposure check | |
Accommodation | Individual housing |
Acclimatization | At least 5 days, usually 7 days |
Administration | Intranodal, every two weeks, 5 times points |
Mortality | Twice daily |
Clinical signs | Daily cage-side clinical observations (twice on days 1-3 and once on |
days 4-56 | |
Food consumption | Weekly |
Body weight | Weekly |
Toxicokinetics | Group 1 (control): |
3 samples/sex, 2 intervals/day in weeks 1 and 8 | |
Group 4: | |
3 samples/sex, 5 intervals/day in weeks 1 and 8 and | |
4 samples/sex, 1 interval/day in weeks 1 and 8 | |
Number of samples: 100 | |
Number of TK-curves: 4 (the control group will be used f or exposure | |
check only, no curves will be evaluated) | |
Clinical pathology | Hematology (5/5 animals per dose), clinical biochemistry (5/5 animals |
per dose) and urinalysis (pooled urine samples from 5/5 animals per | |
dose) in all toxicity testing animals after week 6 and at necropsy. | |
Pathology | Necropsy (all toxicity testing animals), organ weights (according to |
guidelines). Histopathology examination of the collected organs/tissues | |
in all animals of groups 1 and 4 and in all animals, which were | |
sacrificed or died spontaneously during the study. All gross lesions of | |
all animals will be evaluated histopathologically. Necropsy of all | |
toxicokinetics animals, samples of liver, spleen, lymph nodes, brain, | |
kidneys, lungs and bone marrow will be frozen in liquid nitrogen and | |
sent to the sponsor on dry ice), | |
GLP | Fully GLP compliant |
Price of the Study | € 155'000.-- |
RCC Study A99270 of October 18, 2006 / bon | 2/5 |
1359073.1 |
RCC
Linking Science to progress
General
The prices do not include VAT and are applicable for test items where common safety precautions and treatments are sufficient.
Schedule
The studies will be planned individually and initiated after receipt of the signed study contract, the test item and all necessary test item information (Data Sheet, analytical method etc.)
Capacity Reservation
RCC reserves herewith the necessary capacity for the above mentioned studies. The Client will provide the test item and the necessary test item information on time.
Terms of Payment
50% at start of the study
40% on delivery of the draft
report
10% plus final account on delivery of the final report or latest
eight weeks after delivery of the draft report.
Invoice Address
ImVisioN GmbH Prof.
Xx. Xxxxx Xxxx
Xxxxxx-Xxxxx-Xxxxxxx
0
00000 Xxxxxxxx
Xxxxxxx
Standard Conditions
The Standard Conditions of RCC form an integral part of this study contract.
RCC Ltd | For the Client | |||
/s/ Xx. Xxx Xxxxxxxx | /s/ Xx. Xxxxxxx Xxxxxx | /s/ Prof. Xx. Xxxxx Xxxx | ||
Xx. Xxx Xxxxxxxx | Xx. Xxxxxxx Xxxxxx | Prof. Xx. Xxxxx Xxxx | ||
Head of Subchronic | Study Director | |||
Rodent Toxicology | Rodent Toxicology | |||
Date: October 18, 2006 | Date: 31 Oct. 2006 |
RCC Study A99270 of October 18, 2006 / bon | 3/5 |
1359073.1 |