General terms and conditions of business of ClinDescience GmbH,
Gabelsbergerstraße 36, 80333 München




I. Scope of the general terms and conditions of business

1. These general terms and conditions of business apply to the provision of our services in the field of scientific, preclinical and clinical development of medicinal products to merchants listed in the commercial register in the terms of the Commercial Code, as well as to institutes under public law.

2. All our quotations and services are exclusively provided on the basis of these general terms and conditions of business. We are therefore not able to accept any contrary terms and conditions of business of the client.


II. Effecting of a contract

Our written order confirmation is decisive for the contents and remuneration of our services, such as strategic advice in the development of medicinal products, product evaluation, production of scientific expertises, creation of development and study designs, assistance in the case of product licensing and preparation and evaluation of clinical studies, as well as the performance of events. In the case of a specially elaborated quotation with time commitment and timely acceptance by the client, our quotation is decisive.


III. Events

If requested by the client, we will co-ordinate events with him, such as meetings with investigating doctors (Investigator Meetings) and, after receiving a corresponding order, organise and carry out such events in his name and for his account.


IV. Prices and payment conditions

1. In addition to the stated prices, value added tax applies at the respective statutory rate.

2. Costs for business trips that in our judgement are necessary will be separately invoiced to the client. Business trips shall be coordinated with the client in advance. The travelling times will be charged on an hourly-rate basis as working time if this is agreed in advance, limited however to 8 hours per day. Business travel by car will be invoiced to the client in accordance with the respectively valid fiscal travelling expense directives, currently € 0.30/km, domestic travel by air will be invoiced at the actually incurred costs for Economy Class, international travel at the actually incurred costs for Business Class, overnight accommodation expenses and other travelling expenses for hotels of upper medium class will be invoiced according to vouchers.

3. Other costs that are necessary in our judgement for provision of our services, such as costs for freight and transportation of order-related documentation and materials, telephone conferences with foreign participants and applicable costs for photocopying will also be invoiced to the client separately in the actually incurred amount according to vouchers.

4. The agreed remuneration, as well as the other costs stated under IV.2. and IV.3., shall be paid without any deduction within 14 days after invoicing.

5. The client is not entitled to hold back or set off any payments unless his counterclaims are undisputed or have been recognised by declaratory judgement.


V. Provision of the services

1. We provide our services at the location agreed upon with the client. If no such agreement has been made, Munich/Germany is the place of performance. Completion dates are only binding if they have been confirmed in advance by us in writing.

2. The client shall ensure that we are provided free of charge with all documentation and information necessary for the provision of our services, especially any previous complete evaluations, licensing documents for the performance of clinical studies (IND, CTX), development plans and background information for the investigating doctor (Investigator Brochure) including pertaining data bases and shall name us a contact person who is empowered to make decisions. We affirm that the information provided to us will be treated as confidential and only made known to third parties if the client explicitly so wishes.

3. Client's wishes for the representation of results and for the production of records accompanying clinical studies can only be taken into account insofar as the scientific correctness of our statement is not affected. In case of flat rates, the prices stated in our quotation apply to the production of examination records, reports, development plans, expertises and written advice, for which a maximum of 2 draft versions will be prepared. Any additional draft versions will be invoiced to the client separately on the basis of our respectively valid hourly/daily rates. The results will be delivered in written form.

4. Should we be prevented from providing our services because of industrial dispute, particularly strike and lockout, or because of any other unforeseen hindrance outside our influence and responsibility, such as illness of the assigned specialist personnel, we offer to make up for the non-performance at a later date to be fixed in coordination with the client. If the client does not so wish, our obligation to provide the service and the client's obligation to pay are no longer applicable and the customer is not entitled to assert a claim for non-performance against us. All services provided by us up to that point in time will be invoiced.


VI. Limitations on liability

1. We accept no liability for the client's achievement of specific results, for instance as a result of our provision of product advice for the official licensing.

2. Claims for damages, both against us and also against our vicarious agents, arising from breach of contract, from negligence during conclusion of the contract and from tort are excluded, unless wilful or grossly negligent actions are involved.

3. This limitation on liability also applies to claims for damages due to nonfulfillment, but only insofar as replacement of consequential harm caused by defects, indirect damage or loss or loss of profits is demanded, unless the liability arises from a warranty that was given to the client in order to secure him against the risk of such damage.

4. Our liability is ultimately limited in every case to the foreseeable damage.


VII. Proprietary rights

1. The client has the right to use the concepts, illustrations and seminar documents produced or created by us, insofar as their relinquishment to the client is part of the contract, in his company and for the respective purpose of the contract, e.g. presentation to public authorities etc.. If, outside the purpose of the contract, such material is to be made available to third parties, or copied or published, even as extracts, the client has to obtain our prior written consent.


VIII. Other regulations

1. The assignment of rights or the transfer of obligations under this contract by the client requires our prior written consent.

2. The law of the Federal Republic of Germany shall apply to all legal relations between the parties with no recourse to the conflict of laws provisions.

3. The exclusive place of jurisdiction for all disputes arising directly and indirectly from this contract is Munich/Germany.

4. Collateral agreements, alterations and supplements are not effective unless made in written form.

5. If one of the above regulations is or becomes ineffective or impossible to perform, this does not affect the effectiveness of all the other regulations or agreements.


Status: May 2002