Legal Notices and Terms of Site Use

Notice Regarding No Warranties and Limitation of Liability

Information and documents provided on this Web site are provided "as is", without warranty of any kind, either expressed or implied, including but not limited to, implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Medical Numerics uses reasonable efforts to include accurate, complete and up-to-date information on this Web site; it does not, however, make any warranties or representations as to its accuracy, timeliness or completeness. Medical Numerics periodically adds, changes, improves, or updates the information and documents on this Web site without notice.

Under no circumstances shall Medical Numerics, nor its affiliates, agents or suppliers, be liable to you and/or any third party for any damages, including but not limited to, direct, indirect, incidental, special, punitive, consequential, lost profits, lost revenues, or similar economic loss, whether in contract, tort or otherwise, arising out of the use or inability to use this Web site or any linked site, even if Medical Numerics is advised of such possibility.

Notice Regarding Links to Third Party Sites

There are some links in this Web site that will forward you to other Web sites. These linked Web sites are not under the control of Medical Numerics, and Medical Numerics is not responsible for the contents of any linked site, or any link contained in a linked site, or any changes or updates to such sites. Medical Numerics is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Medical Numerics of the linked site.

Notice Regarding Trademarks

Medical Numerics owns or control a variety of registered and unregistered product names, trade names, trademarks, logos, service names and service marks in the United States and in other countries of the world. The following is a non-exhaustive list of Medical Numerics' names and/or marks:

MEDICAL NUMERICS· The MEDICAL NUMERICS LOGO · SENSOR
SYSTEMS MEDICAL PRODUCTS DIVISION · MEDX · 
NEURONAVIGATOR · NEUROACTIVATOR · NEUROEXECUTIVE ·
NEUROVISUALIZER · MX4 · DIAS · THE REGISTRY.

Except as specifically permitted in accordance with the terms and conditions governing use of this Web site, all use, advertisement, publication, reproduction, display or transmission of any of Medical Numerics names and/or marks in any media without Medical Numerics prior written approval is strictly prohibited to the fullest extent permitted by applicable law.

Limited Use Provision

Medical Numerics authorizes you to copy the documents on the Medical Products Division's Web site for non-commercial use within your organization only, provided that the following copyright notice appears in each and all copies:

Copyright © 2007 Medical Numerics, Inc. All rights reserved.

Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any of Medical Numerics copyright, patent, trade-mark or other intellectual property rights.

MEDx Software License Agreement

IMPORTANT NOTE: PLEASE READ THIS PAGE BEFORE OPENING THE DISK AND TAPE PACKAGES. BY OPENING THE PACKAGE, YOU SHOW YOUR AGREEMENT TO THE TERMS OF THIS LICENSE.

Refund

If you do not wish to follow the terms of this license agreement, you may obtain a full refund by returning this package with your receipt or invoice to an authorized dealer within three (3) days of your purchase. This refund is valid provided that you have not opened any of the disk or tape packages and if all materials related to this package are returned.

Parties to Agreement

This agreement, if accepted, is entered into between Medical Numerics, Inc. (Medical Numerics), a Virginia Corporation, and the individual and/or business entity (you) that has purchased this package of MEDx Image Processing Software.

Definitions

The term "Software" as used in this agreement means the full system, sample and utility computer programs contained in the disks and tape in this package, together with any updates subsequently supplied by Medical Numerics. 

The term "Software Copies" means the actual copies of all or any portion of the software, including back-ups, updates, merged or partial copies permitted hereunder or subsequently supplied by Medical Numerics. 

The term "Related Materials" means all of the printed materials provided in this package or later supplied by Medical Numerics for use with the software.

The term "Academic Discount" means a special discount granted to faculty, staff, and students of accredited, degree-granting institutions of higher learning, in situations where such persons seek to purchase a license to use the Software for non-commercial, research purposes.

Permitted Uses

You may:

• Use the Software on a single terminal or a single workstation of a computer (or its replacement).

• Load the Software into your computer’s temporary memory (RAM).

• Install the Software onto a permanent storage device (a hard drive) as detailed in the instructions contained in the user manual.

• Make back-up copies of the Software provided by Medical Numerics provided they are used only for back-up purposes, and that you keep possession of the back-ups.

This license gives you certain limited rights to use the Software, Software Copies and Related Materials. You do not become the owner and Medical Numerics retains title to all the Software, Software Copies and Related Materials. In addition, you agree to use reasonable efforts to protect the Software from unauthorized use, reproduction, distribution or publication. All rights not specifically granted in this license are reserved by Medical Numerics.

Academic Use

If you purchased a license to use the Software at an Academic Discount, or were granted free of cost a license to use the Software, then you must cite, reference, and/or acknowledge your usage of the Software in any scholarly publication wherein the Software was used to analyze, process, visualize, or otherwise generate any data or illustrations that were used in the planning, composition, validation, or editing of said publication. Such citation, reference, or acknowledgement shall be performed in a manner that is usual, customary, and appropriate for the publication.

Uses Not Permitted

You may not:

• Make copies of the Software except as permitted above.

• Make copies of the related materials.

• Use the Software in a network or multiple user arrangement unless you pay for and obtain a separate licensed software package for each workstation on which the Software will actually be executed.

• Rent, lease, lend, sub-license or transfer the Software, Software Copies, related materials or your rights under this license.

• Alter, decompile, disassemble or reverse engineer the Software, or make any attempt to unlock or bypass any copy-protection systems used in this package.

• Remove or obscure the Medical Numerics copyright and/or trademark notices.

This agreement is effective from the day that you open the sealed disk and/or tape package. Your license continues for fifty (50) years, or until you return to Medical Numerics the original disks and/or tape and any back-up copies, whichever comes first. If you breach this agreement, Medical Numerics may terminate this license upon notifying you in writing. You will be required to return all Software, Software Copies and Related Materials. Medical Numerics may also enforce other legal rights.

Export Restrictions

Both parties acknowledge and agree that all documentation and other technical information and software delivered hereunder ("Technical Data") are subject to export controls imposed by the U.S. Export Administration Act f1979, as amended (the "Act"), and the regulations promulgated thereunder. Recipient agrees not to export or re-export directly or indirectly, any Technical Data without complying with the Act and the regulations thereunder. Recipient certifies that neither the Technical Data nor its direct product is intended to be (a) shipped or exported to certain parts of Bosnia-Hercegovina, certain parts of Croatia, Cuba, Iraq, Libya, North Korea, Yugoslavia, (Serbia and Montenegro) or to any other embargoed country to which the United States has prohibited shipment, or (b) used for any purposes prohibited by the Act or regulations, including without limitation nuclear proliferation or chemical/biological weapons or missiles.

This agreement represents the entire understanding and agreement between the parties regarding the Software, Software Copies and Related Materials and supersedes any prior purchase order, communications, advertising or representations.

This license may only be modified in a written amendment signed by an authorized Medical Numerics corporate officer. If any provision of this agreement shall be unlawful, void or for any other reason unenforceable, it shall be deemed severable from, and shall in no way affect the validity or enforceability of, the remaining provisions of this agreement. This agreement shall be governed by the laws of the state of Virginia.

You acknowledge that you have read, understand, and will abide by every provision of this contract.

MEDx Medical Usage Restrictions Agreement

We wish to thank you for your past support and continued usage of the MEDx medical image visualization and analysis program for UNIX workstations. We have many future plans for the product, and we will advise you through the appropriate channels as these enhancements become available.

At the same time, however, we wish to remind you that the MEDx product is "for research use only" or "for investigational use only." The Department of Health and Human Services (DHHS) National Institute of Health (NIH) defines "research" as...

" ... a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge... " (Cf. 45 CFR 46.102(d))

The "human subject" in research is...

" ... a living individual about whom an investigator... conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between the investigator and subject... " (Cf. 45 CFR 46.102(f))

Similarly, the DHHS Food and Drug Administration (FDA) defines an "investigation" as...

"... a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device... " (Cf. 21 CFR 812.3(h))

The FDA definition of a "subject" is...

" ... a human who participates in an investigation, either as an individual on whom... an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease... " (Cf. 21 CFR 812.3(p))

Within this regulatory framework, then, a clinical investigation can be argued to be a more restrictive form of research, in which the data and information collected are intended to be used to support the claims of a device's safety or effectiveness (the FDA regards software used in medical applications to be a medical device).

At the present time, Medical Numerics makes no representation that the MEDx product is either safe or effective for any intended use for which research may currently be performed.

If you are conducting research or clinical investigations, then by law you are required to obtain prior Investigational Review Board (IRB) approval of the clinical study protocol and of the patient informed consent documents, and to provide each patient/subject with a copy of the completed informed consent document. Similarly, if you are conducting research or clinical investigations using animal subjects, you are obligated to follow Good Laboratory Practices, and to observe the ethical treatment of the animals. If your facility or academic institution receives funding from NIH, or if your IRB has DHHS- approved assurances on-file, then you are obligated to follow the NIH rules, in addition to the FDA rules.

As a consequence of the regulatory status of the MEDx product, you are reminded of the Login Acceptance Screen, reprinted below, in which you acknowledge the regulatory status of the product prior to using its functionality:

You are encouraged to contact your governing IRB or clinical risk manager should you have any additional questions or concerns. We hope that this information clarifies your understanding of the regulatory status of the MEDx product, and look forward to continued dialog with you.

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