STUDY CONTRACT between ImVisioN GmbH, Prof. Dr. Horst Rose Feodor-Lynen-Strasse 5, 30625 Hannover/Germany _____________________________________________________ ___________________________________________ (in the following referred to as the Client)...

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RCC
Linking Science to progress

EXHIBIT 10.21

RCC Ltd.
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STUDY CONTRACT

between

ImVisioN GmbH, Prof. ▇▇. ▇▇▇▇▇ ▇▇▇▇
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________________________________________________________________________________________________
(in the following referred to as the Client)

Contact Person: Prof. ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, tpi Consult GmbH, Seelze / Germany

and

RCC Ltd, CH-4452 ltingen/BL, Switzerland
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(in the following referred to as the RCC)

Contact Person for this Contract at RCC: ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇

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).

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RCC
Linking Science to progress

Contracted Studies

The Client herewith commissions the following studies to RCC.

RCC Study Number A99270

57-day Toxicity Study, intranodal, mouse, Pharmaceuticals
Scientific Contact: ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇

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

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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.
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Standard Conditions

The Standard Conditions of RCC form an integral part of this study contract.

RCC Ltd				For the Client
/s/ ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇		/s/ ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇		/s/ Prof. ▇▇. ▇▇▇▇▇ ▇▇▇▇
▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇		▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇		Prof. ▇▇. ▇▇▇▇▇ ▇▇▇▇
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

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