1.1 Quote version
This document replaces all previous versions.
1.2 Contracting parties & responsibilities
anaRIC biologics BVBA is an analytical service contracting agency in the field of biologics, responsible for the sales, marketing and business development activities for Anabiotec NV and R.I.C. BVBA. anaRIC biologics BVBA represents the customer interface. Anabiotec NV, R.I.C. BVBA and anaRIC biologics referred to as ‘the Service Provider’.
Anabiotec NV, part of a group of enterprises united under the commercial name ‘Anacura’, is specialized in analytical services (method development, validation, release and stability testing) for pharmaceutical, biological and cell-based products in the pharmaceutical and biotechnological sector. Activities are conducted in a Good Manufacturing Practice (GMP) compliant environment. Anabiotec NV is responsible for analytical activities performed in a GMP compliant environment and non-GMP analytical activities (excluding non-GMP chromatography and mass spectrometry).
R.I.C. BVBA is specialized in non-GMP chromatographic and mass spectrometric analysis. R.I.C. BVBA offers services in research, development, analysis, consultancy, support (incl. instrumentation) and training for applications within the pharmaceutical, biotechnological and chemical sector, in addition to food, environment and toxicology. R.I.C. BVBA will conduct the non-GMP chromatographic and mass spectrometric analysis.
Any deviation in the activities and responsibilities thereof will be explicitly stated in Section 2.
“Materials” shall mean any intangible, tangible, biological, chemical or physical materials.
Client shall provide Service Provider with Materials required for the purpose of performing the Services. Transportation of Materials will be conducted by the Client at his own risk and expense.
The safety sheet of the Materials will be provided by the Client if required.
The Client acknowledges that activities performed by the Service Provider may reveal the need for additional Materials (for example: removal of interfering agents, concentration or other) and will accommodate Materials requests accordingly.
1.3.3 Proper use
The Service Provider undertakes that it shall not:
- use the Materials other than for the purpose of performing the Services;
- make the Materials available to any third party, except for qualified sub-contractors;
- allow access to the Materials by any of its employees, students or agents except those who are directly involved in performing the Services; or
- make any commercial use of the Materials or any composition made using the Materials.
1.3.4 Retain of the sample
If Service Provider receives more than the quantity of Materials required to perform Services, Materials provided by the Client no longer required for a pending Offer shall be disposed of or, if requested, be returned to the Client at the Clients expenses. On Clients request prolonged storage of the materials can be agreed upon. Additional costs for manipulation and storage will be charged to the Client.
1.4 Performance conditions
1.4.1 Protocols and methods
Finished protocols and methods are provided by the Client if applicable. When methods/protocols are changed in comparison with the by Service Provider obtained methods/protocols at the time of the offer, prices will be reviewed and maybe adjusted. If changes are not included in a new version of the protocol or method, and the Client expects the Service Provider to follow these changes, the Service Provider will set up a system to handle accordingly. The extra hours performed, will be charged accordingly.
If reviewing or writing of protocols/methods is required, the Service Provider can support the Client at consultancy rate. Feedback on the (draft) protocol/Method from the Client has to be provided within 2 weeks and approval by the Client will be requested and the Client accepts all risks involved with the performance of the protocol/method.
Prices are valid for standard reporting of final results. Price setting for tailor-made reporting is available on request. Draft reports will be sent to Client for reviewing. Feedback from the Client has to be provided within 2 weeks. If multiple feedbacks or multiple revisions of the reports are requested, the Service Provider can support the Client at consultancy rate.
Manpower and equipment resources will be reserved by Service Provider in this timeframe, based on an average workload of 8 hours a day. Hours, which Service Provider will not be able to perform, due to delay or cancellation of samples or due to reprioritization of analyses sequence, will be charged according the applicable prices. In case additions to the work package proposed under Section 2 and 3 are requested (e.g. extra methods, extra samples, etc.) the prices and timelines will be reviewed and may be adjusted upon approval by the Client.
1.4.4 Lead time
To allow smooth sample reception, storage and planning, Service Provider requires Client to send a 5 day prior notice of sample delivery. Lead time will be agreed upon by the Client and included in section 2 and 3. In case of changed number of samples or reprioritisation of analyses, lead times may be adjusted and will be discussed with the Client.
Consultancy activities not included in this quote (e.g. extended data interpretation, defining next steps of the Client’s experimental design) will be discussed with and approved by the Client. Consultancy activities will be charged at 236 €/hour.
1.4.6 Quality system
When required activities will be conducted according to GMP standards (as stated in §2), except for supportive, indicative or “for information only” experiments. Details and conditions will be described in a separate Quality Agreement.
The Service Provider will perform its activities based on the internal SOP’s and procedures, unless stated otherwise.
1.5 Obligation of means
The Service Provider shall carry out all orders received to the best of its knowledge and ability, prudently and according to the rules of the trade, however without guaranteeing that by executing the order the desired result shall be achieved (regardless whether the offer or the request for an offer included a description of the desired result).
1.6 Unexpected issues
Should any technical difficulties arise during analysis which could not have been foreseen earlier and which will result in a time and/or cost increase, the Client and Service Provider will jointly agree a resolution on the issue.
For analytical services provided in a GMP-compliant environment, should any unexpected results arise during the project (e.g. OOS, fail on a validation,…), the Service Provider will initiate an internal investigation. If the investigation concludes that the quality of the analytical activities performed by the Service Provider is not engaged, the Service Provider can support the Client in their further investigation at consultancy rate.
1.7 Intellectual property and ownership
Nothing in this Agreement shall affect a Party's rights to its Background Intellectual Property (IP), being the Intellectual Property generated before the service collaboration, nor imply grant of any license to a Party's Background IP unless expressly set forth herein.
Service Provider agrees that:
- all data, materials and reports, and all rights therein (the “Project Results”); and
- all Intellectual Property Rights (the “Project IP”);
conceived, created, developed and or otherwise invented as a result of performing the Services shall be owned exclusively by the Client.
Service Provider shall, promptly disclose all Project Results and Project IP to the Client and provide copies of all documents relating to the same to at its request at any time during or after request at any time during or after the term.
1.8 Force majeure
The Service Provider shall not be liable or deemed for failure to perform any order, where this failure has been occasioned by fire, strike, raw material market shortage and inevitable accidents or any other cause outside the reasonable control of the Service Provider.
The Client shall defend, indemnify and hold the Service Provider harmless from and against all Third Party claims and will indemnify the Service Provider for all direct damages, costs and expenses related thereto, arising out of or resulting from any action attributable to Client failure to comply with its obligations under this Agreement or breach of any warranty made hereunder.
Client shall not be liable to indemnify and hold harmless the Service Provider to the extent that claims arise out of the negligence or willful misconduct of the Service Provider.
The Service Provider shall maintain insurance cover consistent with the normal business practices limited to the amount mentioned in the insurance contract and, upon request, provide the Client with certificates of insurance attesting to the existence of such insurance.
1.10 Payment terms & conditions
Payment conditions: 30 days after invoice date. VAT (value added tax) is not included.