User's Manual
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exclusive right to use the Licensed product(s) (i) solely with the Licensed Software and Licensed
Hardware provided as component parts of the Licensed Product, and (ii) solely for its intended
use in testing endothelial function in accordance with the provisions of this License Agreement
and the instructions provided in the documentation accompanying the Licensed Software,
Licensed Hardware and Licensed Product, subject to the limitations on Use in Section 2.3 and the
Restrictions on Use as provided in Section 2.5.
2.4. LIMITATIONS ON USE. The licenses granted in Sections 2.1, 2.2 and 2.3 above are for use
in normal medical practice, and you are not licensed or authorized to include, or use in any
manner, or to provide to any third party for such inclusion or use, any test results derived from the
VENDYS
® _and/or the Licensed Software and/or Licensed Hardware for the purpose of obtaining
any regulatory approval from any governmental or regulatory agency of any diagnostic or
therapeutic claim, or medical device, pharmaceutical or other therapeutic or diagnostic product.
Without derogating from the generality of the foregoing, the inclusion by you of any third party
of any results of any type, derived through the use of the VENDYS
® _and/or the accompanying
Licensed Software and Licensed Hardware, in any regulatory filing for the purpose of supporting,
or obtaining such approval, without the prior written consent of Endothelix is expressly
prohibited. THIS LIMITATION REFERES SOLELY TO THE SEEKING OR OBTAINING OF
DIAGNOSTIC OR THERAPEUTIC CLAIMS AND NOTHING IN THIS AGREEMENT,
INCLUDING THS LIMITATION ON USE, IS INTENDED, IN ANY MANNER, TO
RESTRICT THE REPORTING OF INFORMATION REGARDING THE VENDYS
® IN
ACCORDANCE THE REPORTING REGULATIONS OF ANY GOVERNMENTAL OR
REGULATORY AGENCY.
Notwithstanding the foregoing limitations on use, you are granted permission to use the data and
compilations obtained from your use of the Licensed Product for the following limited purposes,
under the further strict limitation in such use, of your compliance with all patient privacy rights as
provided under governmental law or regulation for patient privacy and for use and compilation of
medical information and research group data from individual patient applications and data
collection, including:
a) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product for educational, scientific, or research purposes, including data
compiled and extracted from use of the Licensed Product, for the purpose of illustration,
explanation, example, comment, criticism, teaching, research, or analysis;
b) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product in the preparation of Course Packs or other educational materials;
c) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product for use in connection with specific courses of instruction offered
by you for medical education purposes; and
d) You may transmit to a third party in hard copy or electronically, minimal, insubstantial
amounts of collected data compiled and provided you under the programmed use of in the
Licensed Product for scholarly, educational, or scientific research or professional use, but in no
case for resale or commercial purposes.
2.5. RESTRICTIONS ON USE. Any use of the Licensed Software, Licensed Hardware and/or
Licensed Product other than as set forth in Sections 2.1, 2.2, and 2.3 above, in each case as
limited by Section 2.4 above, is strictly forbidden. Without derogating from the generality of the
above you may not:
a) distribute, reproduce, copy, assign, rent, lease, or otherwise transfer the rights granted to you
under this License Agreement to any third party except as explicitly set forth in this License
Agreement;
b) reverse engineer, decompile, or disassemble, as applicable the Licensed Software, Licensed