Preview | Master Services Agreement | Igeneon Krebs-Immuntherapie Forschungs und Entwicklungs-AG; Immunicon Corp

(1) Immunicon Corp. the registered office which is situated at 3401 Masons Mill Road Huntingdon Valley, PA 19006 ("CRO"); and

(2) IGENEON Krebs-Immuntherapie Forschungs- und Entwicklungs AG, Brunner Str.59, A-1230 Vienna ("Sponsor").

(A) The Sponsor is responsible for the initiation, management, and/or financing of Clinical Trials.

(B) CRO has established a method of determining disseminated tumor cells in peripheral blood and bone marrow that has proven not to interfere with the immune response generated by the Sponsor's IGN101 vaccine.

(D) Where CRO agrees to undertake the Services it will be on the terms and conditions set out in this Agreement.

The following expressions, which are frequently used in this Agreement, shall have the meanings attributed to them below. Other less frequently used expressions are defined in the body of this Agreement.

Expression		Meaning
"Assay"		means the System of laboratory analysis of CRO to determine and quantity disseminated tumor cells in Samples of peripheral blood or bone marrow.
"Clinical Trial"		means the clinical trial as detailed in a Protocol.
"Change Order"		means a minor amendment or addition to any Order. This can be requested by either party and must be agreed in writing through a Change Order Form before implementation.
"Ethics Committee"		has the same meaning as it does in the ICH Guideline
"Essential Document"		has the same meaning as it does in the ICH Guideline.
"Effective Date"		is XXXX.
"Good Clinical Practice"		has the same meaning ascribed to it in the ICH Guideline.
"Good Laboratory Practice"		has the same meaning ascribed to it in the Guidance for Industry and the Good Laboratory Practice ICH Guidelines.

"ICH Guideline"	means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) as the same may be amended or re-issued from time to time.
"Investigators"	means those registered medical practitioners responsible for the conduct of Clinical Trials at Trial Sites. In the event that a Clinical Trial is conducted by a team of individuals at a Trial Site, all of the team members are Investigators and the Investigator leading the team, when referred to separately from the other Investigators, will be called the Principal Investigator.
"Investigational Product"	has the same meaning as it does in the ICH Guideline.
"Materials"	means any and all materials provided by the Sponsor to the Investigators in connection with this Agreement including but not limited to any Investigational Product.
"Modification"	means a major change to any Order or Service that requires a new Order to be agreed.
"Order"	means a request made by the Sponsor to CRO for CRO to arrange for the Services to be provided in respect of a Clinical Trial which is accepted by CRO on the terms detailed in a Clinical Trial Order in the form detailed in the Schedules One.
"Proprietary Information"	means:
	(a)	in the case of CRO, any and all information which is now or at any time hereafter in the possession of CRO and which relates to the Assay and System and CRO's business, including without limitation research, data, know-how, formulae, technical operations, processes, designs, patents, photographs, drawings, specifications, software programmes, samples, other matters related to CRO's business and any other material bearing or incorporating any information relating to the System;

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