IBACON GmbH

General
The terms stated herein are agreed to be those which will apply to a single study or several studies (project(s)) performed for the contracting company (Sponsor or Sponsor's monitor) by Institut für Biologische Analytik und Consulting IBACON GmbH (IBACON), Arheilger Weg 17, D-64380 Rossdorf, Germany, as long as no individual agreement between Sponsor or Sponsor's monitor and IBACON was arranged.

IBACON shall perform the project(s) as an independent contractor of Sponsor or Sponsor's monitor and shall have complete and exclusive control over its employees and agents and all technical equipment.

Confidentiality
IBACON shall keep confidential and shall not disclose to any third party at any time without the written consent of Sponsor or Sponsor's monitor any information received in confidence from Sponsor or Sponsor's monitor relating to any of Sponsor's studies unless such disclosure is required by law. If such disclosure is requested by legal process, IBACON will notify Sponsor or Sponsor's monitor of this request.

Protocol
IBACON will perform a study or studies according to detailed written protocol document(s) (protocol(s)). Each protocol will specify the study design, information desired, estimated duration of the study and all other matters pertinent to completion of the study. The protocol will appoint a study director to be responsible for the completion of the study and a representative of Sponsor or Sponsor's monitor (Study monitor or monitoring Scientist). If not otherwise agreed in the protocol all communications between Sponsor or Sponsor's monitor and IBACON regarding the conduct of the study shall be addressed to or routed through the study director and Sponsor or Sponsor's monitor's representative.

A protocol becomes valid by IBACON´s study director signature and has to be signed and acknowledged by IBACON´s management, the Sponsor or Sponsor's monitor (Study monitor) and the Quality Assurance Unit (QAU).

The protocol(s) will be prepared either by IBACON (standard protocol(s)) or in consultation with and / or assistance of the Sponsor or Sponsor's monitor in order to be consistent with current regulatory guidelines. However, IBACON does not warrant that the study design and / or the study results will satisfy the requirements of any regulatory agencies at the time of submission of study results to such agencies.

The protocol(s) may be modified (amended) at the discretion of the study director and / or in consultation with the Sponsor or Sponsor's monitor. Detailed descriptions of all amendments are committed to writing and become valid by IBACON´s study director(s) signature and have to be signed and acknowledged by IBACON´s management and the Sponsor or Sponsor's monitor.

Study Performance
IBACON will use its best efforts according to the present state of science and technology to provide facilities, all technical equipment and staff needed to complete the study as described in the protocol and protocol amendments, if appropriate, and in accordance with the terms of this agreement.

IBACON may employ external consultants and laboratory or field capacity for specific needs of the project. IBACON will be responsible for the work of its external resources in the same way as for its own work.

Study Materials
The Sponsor or Sponsor's monitor will provide IBACON free of charge with sufficient amounts of all compounds, materials or other substances with which the study shall be performed, as well as the necessary data to enable IBACON an appropriate handling of the material concerning e.g. identification, stability, storage and safety requirements.

If delays in the agreed commencement or performance of the study occur because of Sponsor's or Sponsor's monitor's inability to supply IBACON with test materials or information required to begin or perform the study, IBACON may reallocate resources being held for performance of the study without incurring liability to Sponsor or Sponsor's monitor.

Reports
IBACON will prepare the results of all studies in IBACON´s standard report format, unless otherwise specified in the protocol. IBACON will provide a draft report on completion of the project. On receipt of Sponsor's or Sponsor's monitor's approval or four weeks after dispatch of the draft, whichever is sooner, IBACON will provide one original and one copy of the final report.

Additional copies of reports and Interim reports not specified in the protocol and / or copies of or original raw data will be provided at the Sponsor's or Sponsor's monitor's request and expense.

IBACON will not publish any report or data prepared by IBACON for Sponsor without prior written consent of the Sponsor. This consent shall not be unreasonably withhold.

Use of names
Neither party shall use the name of the other party or the names of any of its staff for any advertising, promotional or other public purposes without the prior written consent of such party.

Regulatory Affairs
IBACON will perform all studies in accordance with all applicable current government regulatory requirements concerning test guidelines and Good Laboratory Practices (GLP) appropriate to the study, as specified in the study protocol.

Retention of data and material
IBACON will retain raw data and / or samples of the test material and / or copies or originals of the protocol, amendments and report as appropriate and necessary in compliance with regulatory and GLP requirements. Upon expiration of any regulatory requirements to maintain such data or material Sponsor or Sponsor's monitor will be asked and shall direct whether to destroy such data or material, to retain for a standard storage fee or to transfer to any address specified by the Sponsor or Sponsor's monitor on Sponsor's or Sponsor's monitor's expense.

Patents and Inventions
All discoveries and patentable inventions, excepting methodological innovation arising during the study shall be the property of Sponsor or Sponsor's monitor.

Indemnities
In the event of a material or technical error by IBACON in the performance of the study which renders the study invalid, IBACON´s sole obligation to Sponsor or Sponsor's monitor shall be for IBACON, at its option, to either repeat the study at IBACON´s cost or to refund Sponsor or Sponsor's monitor the contract price paid. In no event will IBACON be liable to Sponsor or Sponsor's monitor for any indirect or consequential losses or damage on account of such error.

IBACON shall indemnify Sponsor or Sponsor's monitor from any claims by IBACON´s employees or others arising out of IBACON´s negligent acts giving rise to any personal injury, death or property damage occurring during the conduct of the study. Except for IBACON´s wilful acts, IBACON will not be liable to indemnify Sponsor or Sponsor's monitor against any loss of expense resulting from any claim arising out of Sponsor's or Sponsor's monitor's use of the study or its marketing of any substance which is subject of the study.

Sponsor or Sponsor's monitor shall indemnify IBACON from any claim for personal injury, death or property damages arising out of a failure to warn IBACON of any dangerous property of the test material or any other item supplied to IBACON by Sponsor or Sponsor's monitor. Sponsor or Sponsor's monitor shall indemnify IBACON from any claim or expense arising out of Sponsor or Sponsor's monitor's use of the study or its use or marketing of any substance tested by IBACON.

Force Majeure
Either party shall be excused from performing its obligations under this agreement if its performance is delayed or prevented by any event beyond such party's reasonable control, including but not limited to fire, explosion, weather, decease, war, insurrection, civil strife, riot, government action, or power failure, provided that such performance shall be excused only to the extent of and during such disability. Any time specified for completion of performance in the protocol failing due to during or subsequent to the occurrence of any of such events shall be automatically extended for a period of time equal to the period of such disability. IBACON will promptly notify Sponsor or Sponsor's monitor if, by reason of any events referred to herein, IBACON is unable to meet any such time for performance specified in the protocol. If any part of the study is invalid as result of such disability, IBACON will, upon written request of Sponsor or Sponsor's monitor but at Sponsor's or Sponsor's monitor's sole cost and expense, repeat that part of the study affected by the disability.

Termination of Studies
Sponsor or Sponsor's monitor may at any time terminate any study prior to completion by giving written notice to IBACON. In such event, IBACON shall immediately comply with such notice to terminate work on the study and use its best effort to reduce cost to Sponsor or Sponsor's monitor. Sponsor or Sponsor's monitor shall pay IBACON all of its cost incurred or irrevocably obligated, plus a pro rata portion of applicable profits determined in accordance with IBACON´s ordinary accounting system computed to the date of termination.

Either party may terminate this agreement in the event of breach of a material obligation of the other if such breach remains uncured after 30 days notice.

The termination of this agreement shall not relieve either party of its obligations to the other in respect of confidentiality of information, consents for advertising purposes and publications, indemnification and compensation for services performed.

Visits
Sponsor's or Sponsor's monitor's representative(s) may visit IBACON at reasonable times and with reasonably frequency during normal business hours to observe the progress of the study. IBACON will assist the Sponsor or Sponsor's monitor in scheduling such visits.

Assignment
This agreement shall not be assigned in whole or in part by either party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed. Any attempt to assign this agreement without such consent shall be void and of no effect.

Proper Law
This agreement and the rights of Sponsor or Sponsor's monitor and IBACON shall be construed and enforced in accordance with the laws of the Federal Republic of Germany.

Modification of this Agreement
This agreement shall not be waived, released, discharged, changed or modified in any manner except by an instrument signed by the duly authorised officers of each of the parties hereto, which document shall make specific reference to this agreement and shall express the plan or intention to modify same.

General Terms of Business