
User Guide for GLYCOCHECK US models including: Measurement System Software, System Software, Software
For Practitioners – GlycoCalyx
File Info : application/pdf, 23 Pages, 6.50MB
DocumentDocumentGlycoCheckTM Measurement System
User Guide
Operating instructions and guidelines for GlycoCheck Measurement System
GlycoAcquisition version 0.9.0.12x GlycoAnalysis version 1.0.0.x
Contents
Preface ............................................................................................ 2 Introduction .................................................................................... 3 Assumptions ................................................................................... 3 Intended Use ................................................................................... 3 Warnings ......................................................................................... 3 Patient Testing Instructions ......................................................... 3 System Setup...................................................................................4 Software Operation ....................................................................... 6
Select a Study ........................................................................... 6 Patient Setup ........................................................................... 7 Perform the Measurement ..................................................... 8 GlycoAcquisition Software............................................................ 9 Test Screen ............................................................................... 11 Camera Readouts ...................................................................12 Results Screen .........................................................................15 Backing Up and Restoring Your System .....................................16 Click-Wrap Annual License Agreement ..................................... 19
Preface
© GlycoCheck US LLC. All rights reserved. No one is allowed to reproduce or duplicate, in any form, this document or any part thereof without written permission from GlycoCheck US LLC (GlycoCheck US).
GlycoCheck US assumes no responsibility for any injury, or for any illegal or improper use of the software, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for installation and configuration published in this manual.
The GlycoCheck software is protected by international patents* and copyright laws. The licensee is entitled to use the copy of this software supplied with this product as intended in the operation of the software. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with GlycoCheck US.
Caution: changes or modifications not expressly approved by GlycoCheck US could void the purchaser's authority to operate the equipment.
GlycoCheck is patented in the United States, Canada, Europe (Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, The Netherlands, and United Kingdom), China, and Japan.
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Introduction
This manual provides operating instructions and guidelines for the GlycoAnalysis Measurement System Software Version 5.3.3 and GlycoAquisition client.
GlycoAnalysis 5.3 / GlycoAquisition Client Software Overview
The GlycoAnalysis 5.3 software is where the patient database is located and all of the calculations of the videos that are acquired and processed through the algorithms to generate the MicroVascular Health Score.TM The GlycoAquisition client is the camera acquisition application.
Assumptions
The instructions in this guide assume that the user has completed the online training course at the Boston BioLife Academy (https://www.bostonbiolifeacademy.com/courses/ glycocheck-training-p1). A Certificate of Completion of the test confirms that the user understands the proper use of the GlycoAnalysis® Measurement System and that he or she has the required medical education and/or experience to operate this equipment safely and effectively.
Intended Use
GlycoAnalysis Measurement System is intended solely for the visualization and characterization of the Perfused Boundary RegionTM (PBR), microvascular density, and MicroVascular Health Score.TM No diagnostic or therapeutic claims are made for the sof tware.
Warnings
· To safely use the GlycoAnalysis Measurement System software, always connect the laptop computer to a wall outlet with a medical grade adapter.
· For safety, hygiene and camera lens protection purposes, always use a new sterile single-use GlycoAnalysis lens cover for each measurement.
· When not in use, store the camera with the protective lens cover with the red tape.
Patient Testing Instructions
Inform patients to follow these instructions before testing:
· Do not eat or drink anything other than water for 6 hours before your test.
· Do not exercise for 12 hours before your test. · Do not consume alcohol for 24 hours before your test. · Drink at least 1 quart of water 1 hour before your test. · Do not drink caffeine the day of your test. · 1520 minutes of rest (to reduce the level of stress) before your test.
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System Setup
1. Connect the laptop computer to a wall outlet with the power supply. THIS IS ESSENTIAL--Working on battery power only, without connecting the power supply to a wall outlet, will not supply sufficient power to both the computer and the digital microscope camera, and may lead to sof tware problems and permanent database errors. Power cord must be connected to a surge protector.
2. Plug the KK Model HVCS Camera into available USB-C port. May be used with USB-C to a USB 3.0 adaptor and plugged into blue USB port.
3. Turn computer power on (right top corner button). Click Enter on keyboard.
4. Log in using password: GlycoAdminPW
5. Double-click on the GlycoAnalysis application icon on the computer desktop or single-click on the GlycoAnalysis icon in the taskbar.
6. Scroll through the Click-Wrap License and click I understand and agree with terms and conditions.
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7. Type username: Recorder and password: RecorderPW (case sensitive). 8. Click on OK. The software is now ready to begin a glycocalyx measurement.
7 Enter User Name and Password
9. Your camera is pre-calibrated so you may click Skip Calibration.
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Software Operation
The GlycoAnalysis software is designed to follow a specific workf low, making relevant features available on the screen as needed. You will find appropriate buttons for these features. In order to perform a successful glycocalyx measurement, follow these workf low steps. You can see the current step in the workf low bar at the top of the screen. Note: this is not a menu bar.
1. Select a Study
Select your study in the left column. If there is only one study defined it will be selected by default. New studies can be defined by clicking on Add a study on the lower left of the screen. Cick on Dynamic Study.
1 Select your study
Define a new study
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Software Operation continued
2. Patient Setup
· Select an active patient from the patient list in the Patients list section in the second column. To run a repeat test on an existing patient, scroll down the list and click on patient name or ID. If the patient is not on the list, register a new patient with these steps:
· To register a new patient: A. In the Auto Search Modus, use the dropdown arrow, click on Find by Name. That will reset the patient registration section.
B. Select Add New Patient in the Auto Search Modus dropdown menu. C. In the Patient ID box, type the patient ID (name) of the patient. Type Last Name
followed by First Name (Smith John). D. Enter Date of Birth starting with 2-digit day, 2-digit month and 4-digit year
separated by hyphens (00-00-0000). If the birth date is entered incorrectly, the box will be lined in red. E. In [Last Name] box, enter Patient's Last Name (not case sensitive). F. In [First Name] box, enter Patient's First Name (not case sensitive). G. Select Male or Female. H. Enter Location where test is conducted (office, clinic, hospital, etc.) If you need to change the patient location, click on Update Location at the bottom of the Patient Registration section and make the change. I. Click Add Patient to add the patient to the database. The message "Please wait until patient data is ready" appears when the software is uploading the patient data to the database.
2 Select an active patient
A
... or add
B
C
new patient
D
E
F G
H
I
Do not discharge the patient. If you do, they are removed from the patient list and no longer visible.
Note: If the name of the patient is not in the ACTIVE PATIENT LIST, click on the tab `Discharged' above the Patients list, to see if the patient was discharged. If so, the patient can be admitted again by pressing the `Admission' button. Click the ADMISSION button to save the patient to the PATIENTS list under the `Admitted' tab.
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Software Operation continued
3. Perform the Measurement
A. Sanitize your hands. It is preferred that you use single-use sterile procedure gloves.
B. Explain to the patient the steps in the glycocalyx measurement process to help them relax.
C. Place a new GlycoAnalysis lens cover on the camera tip, pushing it gently into place, making sure that the lens cover end is securely against the end of the lens tube. Do not touch lens with ungloved hands. If you do not glove your hands, handle lens by carefully opening the plastic lens packaging and use the packaging to avoid touching the lens.
D. Do not point the lighted camera tip at the patient's eyes. E. Click the Patient Screen button highlighted in blue.
E
Perform new visit
F. Minimize your screen by clicking on the single line on the left. The program will remain open in the task manager bar found at the bottom of the screen.
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GlycoAcquisition Software
The GlycoAnalysis 1.0.0 software is where patient database is located and all of the calculations of the videos that are acquired and processed through the algorithms to generate the MicroVascular Health Score.TM The GlycoAcquisition 0.9.0.126 software is the camera acquisition application.
1. Open the GlycoAquisition client by double clicking the GlycoCheck icon shown on your desktop, or click on the icon on your taskbar.
YOUR GLYCOCHECK SYSTEM MUST BE ONLINE WITH A STABLE INTERNET CONNECTION IN ORDER FOR THE GLYCOAQUISITION CLIENT SOFTWARE TO FUNCTION.
2. When you double-click on the GlycoAquisition client icon, the program automatically checks for software updates. Updates are pushed regularly. If no update is present, you will go immediately to the GlycoCheck license screen. If an update is required, you will be asked if you want to do the update. Click Yes and the software will be updated to the latest version. When complete, the GlycoCheck license agreement will be shown.
3. Scroll to the bottom of the license agreement and click I Agree.
4. On the dropdown menu, select IDS Imaging Development.
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GlycoAcquisition Software continued
5. The next screen is Find your patient. Type the patient's name or patient ID, last name first.
Once you type in the name, a list of patients with that name will appear. Scroll through the list and identify the correct patient (in this example, it is Robert Long 1). It will appear in gray when you hover over it. Click on the name and select that person.
You will be asked to verify that this is the correct patient. Confirm, then click Start Test.
Once you've clicked Start Test, you will be asked to select your visit length. You can choose to do a Short measurement for clinical tests, or to do a Long measurement for academic tests. Both tests will produce a MicroVascular Health Score. The benefit of a short test is that it can be completed in less than 5 minutes, and also that the time to complete the analysis of the measurement is less than 5 minutes. The Long test will provide additional parameters like Recruitment Capacity, but time to complete a Long measurement and to do the analysis is more than 5 times longer than a short test, which may not be practical in a clinical setting.
Once you've clicked Start Test, you will be asked again to verify that this is the correct patient. Once you've selected Yes, you will be presented with the test screen as shown below. The camera will turn on and the green LED lights will begin to f lash.
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GlycoAcquisition Software continued
Here is an explanation of each of the items you see on your screen as you perform a measurement:
A Collection Progress: The green bar shows visually how far the collection of videos has progressed.
See next page for information about these camera readouts
F
B Recordings collected: The number
on the right is the estimated number
of recordings that need to be collected
based on what has been collected. It
starts at 2,000 and as you progress the
estimated number drops based on the quality of the videos you are collecting. A
In this example, an estimated 276 more B
video images need to be collected.
C
The number on the lef t is the progress
D
based on the actual number of record- E
ings collected. In this example, 27
recordings have been collected.
G
H
C Recordings accepted: The number of recordings the sof tware has accepted for analysis. The sof tware analyzes and conducts quality assurance checks on each video as it is received. In this example, 9 recordings have been accepted. This number must reach 64 or 384 to complete a short or long measurement, respectively.
D Test completion: The percentage of recordings collected. In this example, it's 0%.
E Pause: Use this button only if you need to pause the measurement. If you click it, you will see a pop-up that says "Paused. Please click on resume to continue or abort to stop the test." When you're ready to resume, click Resume. If it's your intent to abort the test, click Abort.
F Uploading Test: Once tests begin to be accepted, the blue bar will appear at the top of the screen showing the number of tests uploaded for analysis. In this example, 13 out of the 64 required for an accurate short test have been uploaded.
G Online: Green indicates your system is "online." If it's red, it will say "offline." This rarely happens but you must correct it to continue the measurement: Click on the three dots to the far right. A "Settings" dropdown will appear with three options: a) Restart Image Analysis, b) Add Credits, or c) Check for Update (to manually update the system). If you need to Restart Image Analysis, click that button. Once it restarts, a message will appear that it has been reset and your measurement will resume. Click X to close the window and complete your measurement.
H Quit Application: Click this ONLY if you need to quit the measurement.
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GlycoAcquisition Software continued
Motion: The white dot must be within the green bar. The program will not accept the videos if they are in the red bar. Farther lef t within the green bar is better.
Focus: The white dot
must be within the green bar. The program will not accept the videos if they are in the red bar. If possible, keep the white dot centered within the green bar.
Light Intensity: The white dot must be within the
green bar. The program will not accept the videos if they are in the red bar. It is best to keep the white dot centered within the green bar. Occasionally, if the camera isn't positioned correctly, the indicator may "ping pong" out of range. Adjust the camera so it's in focus again and the sof tware will automatically compensate and the indicator will return to the green range.
Three dots in upper right: settings options
K
L
When you click the three dots in the upper right, you will see three options:
K Restart Image Analysis If you need to Restart Image Analysis, click the button. Once it restarts, a message will appear that it has been reset and your measurement will resume. Click X to close the window and complete your measurement.
L Restart Camera If the camera image is frozen, and you need to restart the camera, click the "Restart Camera" button. This will allow you to continue the measurement, and the data that were already collected during the measurement will not be lost.
M Check for Update Click Check for Update at any time to do a manual update. The sof tware is updated automatically when you login. This is another way to check for updates that will be rarely used.
M
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GlycoAcquisition Software continued
6. Once enough measurements have been collected, you will see the screen below telling you it's okay to remove the camera from the patient's mouth. As stated on the screen, it is recommended that you have your patient standby while the system checks to see if sufficient recordings have been accepted to complete the measurement. It's possible a few more recordings will be needed. If that happens, a screen will appear as shown below.
7. If you need to take more recordings, a popup screen will appear. Click Yes to proceed. It usually takes another minute or so to gather more recordings. Once those are quality checked, you will be finished with taking measurements.
8. Once enough recordings have been accepted, you will see a "Test concluded" screen where you can add additional remarks about the test. In the following example, it has been noted that the person tested took supplements this morning and that the patient tracks a sleep score. Also noted was that a protein shake was consumed prior to the test. These remarks can be helpful information when comparing future measurement scores. Click Finish.
It is recommended that you make notations that include feedback from your patient. This gives you a reference point of the patient's information at the time of the test to compare against future tests. If the patient has different timing in supplementation, hydration, sleep quality, or sick, this information provides a reference point.
It's particularly important to ask patients if they have had COVID-19, and if so, how long ago and how sick they were of if they are experiencing long-haul COVID-19.
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GlycoAcquisition Software continued
9. Upon completion of the remarks, you must reopen the GlycoAnalysis program by double-clicking on the GlycoAnalysis icon in the taskbar and the following screen will appear. Click on the Patient Screen button and it will take you back to the patient input screen.
10. When the blue box in the middle of the screen first appears, the number of computations to do will be 384. The computer will estimate the time remaining to complete the test. When this phase is completed, the next box, "Calculating new visits..." will appear. While the program is processing the videos through the algorithms, it is completing 100 million calculations. If the calculations stop processing unexpectedly, please contact GlycoCheck support.
At this stage, the program is processing the 24 complete video segments, doing final calculations and preparing the report.
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GlycoAcquisition Software continued
11. Click on the patient you want to finish the report. In this example, it's Alpine, Tom Jones.
12. Click on the blue box named Patient Screen. The next screen will be the Results Screen.
13. Below is the Results Screen. The most recent test is highlighted in blue and labeled A. This patient had prior tests taken weeks earlier with considerably higher scores. As you can see in the Visit Remarks box labeled B, the patient drank a sugary soda, and ate a quarter-pound cheeseburger and fries. While he took Endocalyx earlier in the day, and used a PEMF mat, his score dropped from 7.92 and 7.74 to 3.29.
B
A
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Backing Up and Restoring Your System
Periodically, you should backup your system. Backing up your system prevents the system from stopping and interrupting a test you are performing.
1. Open the GlycoCheck software and on the Main Screen, in upper right corner, look for the Database dropdown menu.
2. From the options, select Backup Database. The following screen will open:
3. Select the location in the Path dialog box where you would like to store your information, either on your D Drive or External Drive.
4. When finished with the backup, you will see the following screen:
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Backing Up and Restoring Your System continued
5. Return to the Main Screen. In the upper right corner, look for the Database dropdown menu, and under it select Restore Database.
6. After you select Restore Database the following screen will appear. In Path select the backup from either the D Drive or External Drive.
7. Next, select the Filestream Disk dropdown and choose the location of where you wish to restore your files. You can name the new database, for example GSS <Date of restore>. Click Start Restore.
8. When finished with the restore, you will see the following screen.
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Backing Up and Restoring Your System continued
9. Once the restore is finished, return to the Main Screen. In the upper right corner, look for the Switch Database dropdown menu.
10. This dialog box will appear, where it says Select a GlycoCheck Database. Select GSS <Date of restore> (this is the name you chose in Step 7).
11. Your files should now be fully restored.
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Click-Wrap Annual License Agreement
Last updated: 8/06/2024
PLEASE READ THIS CLICK-WRAP LICENSE AGREEMENT CAREFULLY! IT CONTAINS VERY IMPORTANT INFORMATION ABOUT YOUR RIGHTS AND OBLIGATIONS, AS WELL AS LIMITATIONS AND EXCLUSIONS THAT MAY APPLY TO YOU. BY SELECTING THE BOX LABELED "I agree to the Terms and Conditions" AND CLICKING ON THE "Ok" BUTTON, YOU ARE AGREEING TO BE LEGALLY BOUND BY AND ARE BECOMING A PARTY TO THIS AGREEMENT. IF YOU ARE ENTERING INTO THIS AGREEMENT WITHIN THE SCOPE OF YOUR EMPLOYMENT, THEN THE TERM "LICENSEE" INCLUDES YOUR EMPLOYER AND YOU WARRANT AND REPRESENT TO GLYCOCHECK US THAT YOU ARE AUTHORIZED TO ACCEPT THIS AGREEMENT ON SUCH EMPLOYER'S BEHALF. IF YOU DO NOT AGREE TO ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT, DO NOT SELECT THE BOX LABELED "I agree to the Terms and Conditions" AND CONTACT YOUR GLYCOCHECK SYSTEM PROVIDER.
This Click-Wrap License Agreement (this "Agreement") is made between:
1. LICENSE TO GLYCOCHECK SYSTEM
1.1.Subject to the terms and conditions of this Agreement, including the restrictions and license exclusions set forth elsewhere in this Agreement, GLYCOCHECK US hereby grants to Licensee, and Licensee hereby accepts a non-exclusive, non-transferable, limited license (without the right to grant sub-licenses) to use the GlycoCheck System for the purpose of conducting research relating to the vascular and microvascular endothelial glycocalyx of human and non-human animals, subject to the restrictions set forth herein Section 2.
1.2. Licensee shall have no right to sublicense, loan, sell, or otherwise transfer the GlycoCheck System, or any part or component thereof, to any third party without the prior written approval of GLYCOCHECK US.
1.3. GLYCOCHECK US retains all rights not expressly granted to Licensee hereunder. No right or license to Licensee shall be implied by or inferred from this Agreement except as expressly provided herein.
you, both as an individual and as an authorized user of and agent for your affiliated company, if any (each a "Licensee"), and
GlycoCheck US LLC, a company organized and subsisting under the laws of Utah, United States ("GLYCOCHECK US"), with principal offices located at 7 South Lone Peak Drive Alpine, Utah 84004, U.S.A.,
2. LICENSEE'S GENERAL COVENANTS
2.1. Subject to the terms and conditions of this Agreement, Licensee agrees that it will use the Software Product and GlycoCheck System only for the purpose for which it was designed and installed by GLYCOCHECK US.
GLYCOCHECK US and Licensee each a "Party" and collectively the "Parties,"
and is effective of as the first time Licensee selects the box labeled "I agree to the Terms and Conditions" and clicks "Ok" (the "Effective Date") and is reaffirmed by Licensee each subsequent time Licensee selects the box labeled "I agree to the Terms and Conditions" and clicks "Ok."
2.2. Licensee shall not copy, reverse engineer, decompile, recompile, disassemble, or otherwise derive the underlying structure, information or ideas embodied in the Software Product. Licensee agrees such activities constitute a material breach of this Agreement, and are violations of GLYCOCHECK US's Intellectual Property Rights, causing irreparable injury to GLYCOCHECK US which cannot be remedied by monetary damages alone, and which therefore entitle GLYCOCHECK US to injunctive relief.
By providing the GlycoCheck System to Licensee, through Distributor, if any, GLYCOCHECK US agrees to be legally bound by the terms and conditions of this Agreement.
RECITALS
WHEREAS, GLYCOCHECK US is the developer and/or distributor of a proprietary hardware and software system used to measure the Glycocalyx layer and microvascular function (the "GlycoCheck System");
WHEREAS, Licensee wishes to obtain from GLYCOCHECK US, through Distributor, if any, and GLYCOCHECK US wishes to grant and provide to Licensee, through Distributor, if any, a license to use the GlycoCheck System;
NOW, THEREFORE, in consideration of these promises and of the mutual covenants and conditions in this Agreement and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
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2.3. Licensee shall not modify or remove any components of the System Hardware in any manner. Licensee shall not install, attempt to install, nor cause to be installed, any software product on the System Hardware without prior written authorization from GLYCOCHECK US, through Distributor, if any. Licensee agrees such activities constitute a material breach of this Agreement. Any violations of this Section 2.3 shall void any express warranty set forth herein, as well as any warranty implied under the law.
2.4. Licensee shall not use the System Hardware, Software Product, or GlycoCheck System to develop, substantiate the performance of, market, or sell, or assist others to develop, substantiate the performance of, market, or sell any dietary supplement or medical food that is intended to support, maintain, repair or treat the endothelial glycocalyx.
2.5. Licensee agrees that for the term of this Agreement, including the Initial Term and any subsequent Renewal Term, and for a period of one (1) year thereafter, Licensee shall not develop, manufacture, or sell, or assist others in the development, manufacture, or sale,
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of any dietary supplement or medical food that is intended to support, maintain, repair or treat the endothelial glycocalyx.
nection with its use of the GlycoCheck System, or (iii) Licensee becomes bankrupt or insolvent.
2.6. Licensee shall be solely responsible for its and its Authorized Users' use of the GlycoCheck System and shall ensure that Licensee and all Authorized Users abide by and comply with this Agreement in connection with their use of the GlycoCheck System. Licensee shall be responsible to GLYCOCHECK US and any third party for any acts or omissions of Authorized Users, including, without limitation, failure of any Authorized User to comply with the terms of this Agreement. GLYCOCHECK US shall have the right to require Licensee to restrict or deny access to the GlycoCheck System by any Authorized User who is not in compliance with this Agreement.
2.7. Licensee acknowledges that the GlycoCheck System contains a backup utility that is capable of creating copies of the analyses performed by the GlycoCheck System, and capable of securely storing such copies in storage either on the System Hardware or in a cloud-based environment.
3. CONSIDERATION
3.1. In consideration of the license granted herein, Licensee shall pay, or shall have previously paid, to GLYCOCHECK US, through Distributor, if any, a one-time license fee and an annual renewal fee of $1250.00 one thousand two hundred and fifty dollars (the "License Fee") as agreed upon in writing between Licensee and GLYCOCHECK US or Distributor, if any.
4. TERM AND TERMINATION
4.1. This Agreement shall come into effect on the Effective Date and remain in effect for one (1) year, with an annual renewal fee of $1250.00, one thousand two hundred and fifty dollars.
4.2. At the end of the Initial Term, or any Renewal Term subsequent to the Initial Term, this Agreement may be renewed with an additional fee for one (1) year (a "Renewal Term") by the Parties in writing. The renewal of this Agreement shall be effectuated by: (i) Licensee requesting, in writing, a new Software Key from GLYCOCHECK US, through Distributor, if any; and (ii) GLYCOCHECK US providing, in writing, a new Software Key to Licensee, through Distributor, if any. Each Renewal Term shall be subject to the terms and conditions of this Agreement.
4.3. This Agreement can be terminated at any time with the mutual written consent of both Parties.
4.4. GLYCOCHECK US may terminate this Agreement at any time without prior notice and without any liability of GLYCOCHECK US to any party as a consequence thereof, upon the occurrence of any of the following: (i) Licensee has breached any material obligation which must be performed pursuant to this Agreement and such breach has not been cured within 30 days after notice from GLYCOCHECK US of the same, including, without limitation, failure to make any payment when due; (ii) Licensee has violated any applicable law or regulation in con-
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4.5. Licensee may terminate this Agreement at any time, without any liability of Licensee to GLYCOCHECK US as a consequence thereof (other than charges accrued prior to termination), where GLYCOCHECK US has breached any material obligation which must be performed pursuant to this Agreement and such breach has not been cured within 30 days after written notice from Licensee of the same.
4.6. Upon termination of this Agreement by Licensee or GLYCOCHECK US, all license(s) granted hereunder shall cease and terminate. There shall be no refund to Licensee of any Fees paid to GLYCOCHECK US prior to the effective date of the termination, including the License Fee, except as specifically provided herein. Licensee agrees to cease all use of the GlycoCheck System and promptly return the GlycoCheck System and all components thereof to GLYCOCHECK US at Licensee's expense.
4.7. Except as otherwise specifically provided herein, the termination of this Agreement shall not affect the rights, obligations or remedies of either Party which accrued prior to the termination of this Agreement and all such remedies shall survive the termination of this Agreement
5. OWNERSHIP
5.1. All rights, title and interest in the GlycoCheck System, and each and every component thereof, and the Intellectual Property Rights embodied therein shall at all times reside in GLYCOCHECK US. GLYCOCHECK US retains all rights not expressly granted herein
5.2. Licensee agrees and acknowledges that GLYCOCHECK US shall be the sole and exclusive owner of any and all right, title and interest in and to Improvements to the GlycoCheck System, whether made or developed by GLYCOCHECK US or by any other entity.
6. MAINTENANCE AND SUPPORT
6.1. GLYCOCHECK US agrees to provide the GlycoCheck System, with Software Product and System Hardware installed, to Licensee, through Distributor, if any.
6.2. For the term of the warranty identified in Schedule A hereto, GLYCOCHECK US shall provide to Licensee and/or through Distributor, if any, periodic Updates to the Software Product and System Hardware, if and to the extent that said Updates become available. GLYCOCHECK US shall, upon discovery of any known problems with the GlycoCheck System, notify Licensee, through Distributor, if any, of said problems and will provide to Licensee, through Distributor, if any, any discrepancy reports or technical newsletters when such problems are identified and listing all known "bugs" and their status and, to the extent possible, providing "fixes" and/or work-around procedures for such problems.
6.3. From time to time, GLYCOCHECK US may release Upgrades
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to the GlycoCheck System that provide new functionality to the software. Nothing herein shall entitle Licensee to any Upgrade to the
GlycoCheck System. Such Upgrades will be provided to Licensee only
upon payment of an additional license fee to be determined by GLYCOCHECK US upon release of any such Upgrade. Software bug fixes and minor improvements in the software will be provided to Licensee and/
or through Distributor, if any, at no cost, and are not considered to be
an Upgrade for purposes of this Section.
System, with the choice to repair, replace or credit being within the sole discretion of GLYCOCHECK US. The foregoing repair, replacement or credit remedy will be Licensee's sole remedy for breach of the warranty set forth in this Section 7.3. THE FOREGOING LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES AND EXCEPT FOR ANY
EXPRESS WARRANTIES STATED HEREIN, GLYCOCHECK US
EXPRESSLY DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR
IMPLIED.
7. REPRESENTATIONS, WARRANTIES, AND DISCLAIMER OF LIABILITY
7.1. Each Party represents and warrants that it has full power and authority to enter into this Agreement and that performance of its obligation hereunder does not conf lict with or breach the terms and conditions of any agreement with any third party.
7.2. GLYCOCHECK US warrants that it is the developer and/or licensee of the GlycoCheck System, that it has the right to convey the license set forth in Section 1 hereof, and that to the best of GLYCOCHECK US's knowledge, Licensee's use of the GlycoCheck System in accordance with the terms of this Agreement shall not infringe any third-party rights in copyright, patent, or trade secret.
7.3. GLYCOCHECK US warrants (the "Product Warranty") that the GlycoCheck System (as set forth in Schedule A hereto) sold by GLYCOCHECK US to Licensee, through Distributor, if any, and pursuant to this Agreement shall, subject to the other provisions of this Section 7, from the Effective Date and for three (3) years thereafter:
(a) be of satisfactory quality; and
(b) be reasonably fit for its intended purpose.
GLYCOCHECK US does not warrant against normal and/or reasonable wear and tear, normal and/or reasonable corrosion, use of Unauthorized Products, catastrophe, accident, fault or negligence of Licensee, Distributor, or any third party, improper use, alteration or modification, unusual stress, installation, service or repair performed other than pursuant to this Agreement (other than installation, service or repair performed by GLYCOCHECK US and/or its appointees pursuant to this Agreement), defects caused by persons other than GLYCOCHECK US and/or its manufactures, or any other cause other than ordinary use. Accordingly, the Product Warranty does not extend to any GlycoCheck System (as set forth in Schedule A hereto): (a) that have been subject to misuse, neglect, abuse, improper storage, accident, or that have not been properly maintained; (b) that have been modified by Licensee, Distributor, or any third party; or (c) that have been disassembled, serviced, or reassembled by Licensee, Distributor, or any third party. Subject to the foregoing exclusions, if the GlycoCheck System contains a defect in design, materials or workmanship and such GlycoCheck System is returned to GLYCOCHECK US within three (3) years of the Effective Date of this Agreement, GLYCOCHECK US will repair or replace the GlycoCheck System, or issue a credit for the purchase price of the GlycoCheck
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7.4. Written pre-authorization from GLYCOCHECK US, through Distributor, if any, is required for any warranty claim under the Product Warranty set forth in section 7.3. To obtain written preauthorization from GLYCOCHECK US, Licensee shall request written pre-authorization from GLYCOCHECK US, through Distributor, if any, to return the GlycoCheck System or System Hardware thereof for repair or replacement under a valid warranty claim. Upon approval, Licensee shall receive from GLYCOCHECK US, through Distributor, if any, (i) written pre-authorization to return the GlycoCheck System or System Hardware thereof for repair or replacement, (ii) a pre-paid shipping label, and (iii) packaging and shipping procedures for returning the GlycoCheck System or System Hardware thereof for repair or replacement. Licensee shall then package and ship the GlycoCheck System or System Hardware thereof in accordance with the received packaging and shipping procedures.
7.5. The warranty set forth in Section 7.3 shall become null and void upon Licensee's breach of this Agreement, alteration or modification of the GlycoCheck System or component thereof in any way, or use of any Unauthorized Product in connection with the GlycoCheck System or component thereof.
7.6. Licensee acknowledges that the GlycoCheck System is provided to Licensee on an AS IS basis. EXCEPT AS OTHERWISE PROVIDED HEREIN, GLYCOCHECK US DISCLAIMS ANY AND ALL WARRANTIES, EXPRESS, STATUTORY OR IMPLIED, WITH RESPECT TO THE GLYCOCHECK SYSTEM, DERIVATIVE WORKS, AND DOCUMENTATION, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. GLYCOCHECK US MAKES NO WARRANTY THAT THE GLYCOCHECK SYSTEM WILL MEET LICENSEE'S REQUIREMENTS, BE ERROR FREE, OR OPERATE WITHOUT INTERRUPTION.
7.7.THE PARTIES AGREE THAT GLYCOCHECK US, ANY OF ITS AFFILIATED PERSON/ENTITY OR THIRD PARTY VENDORS SHALL NOT BE LIABLE TO LICENSEE (OR ANY PERSON CLAIMING RIGHTS DERIVED FROM THE LICENSEE'S RIGHTS), EXCEPT AS OTHERWISE PROVIDE HEREIN, FOR ANY DIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY NATURE OR KIND WHATSOEVER, INCLUDING, BUT NOT LIMITED TO, LOST REVENUES OR PROFITS, LOSS OF BUSINESS OR OTHER ECONOMIC LOSS, LOSS OF DATA, PERSONAL INJURY, OR PROPERTY DAMAGE IN CONNECTION WITH OR ARISING OUT OF THE USE OF THE GLYCOCHECK SYSTEM AND DERIVATIVE WORKS, IRRESPECTIVE OF WHETHER GLYCOCHECK US HAS ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
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7.8. If the foregoing disclaimers and waivers of liability shall be deemed invalid or ineffective, GLYCOCHECK US, its subsidiaries and affiliates, and any related persons or entities shall not be liable in any and all events beyond the amount of one thousand dollars ($1,000). If the foregoing limitation is held unenforceable, then the Parties agree that GLYCOCHECK US, its subsidiaries, affiliates and any related persons or entities, shall not be liable in any and all events beyond the cumulative total of all fees and compensation paid by Licensee to GLYCOCHECK US under this Agreement (including all the License Fee referenced in Section 3.1). Both Parties agree and understand that the pricing for the GlycoCheck System reasonably ref lects the allocation of risk and the limitations of the liability set forth in this section.
8. TRANSFER/ASSIGNABILITY
8.1. This Agreement may not be assigned or transferred by Licensee to any other entity or person. Any attempted assignment in violation hereof shall be void.
8.2. GLYCOCHECK US may freely assign this Agreement at any time to any subsidiary, parent or other affiliate or to any other party in connection with the sale, merger or other business combination involving all or substantially of that party's assets of the line of business to which this Agreement pertains.
9. GENERAL PROVISIONS
9.1. Relationship of the Parties. This Agreement shall not constitute the designation of either Party as the representative or agent of the other, nor shall either Party by this Agreement have the right or authority to make any promise, guarantee, warranty, or representation, or to assume, create, or incur liability or other obligation of any kind, express or implied, against, or in the name of, or on the behalf of, the other Party.
9.2. No Waiver. The failure of any Party to enforce any of its rights hereunder, or at law, shall not be deemed a waiver or a continuing waiver of any of its rights or remedies against the other Party, unless such waiver is in writing and signed by the aggrieved Party.
9.3. Notice. Any official notice to GLYCOCHECK US, as required by this Agreement, shall be addressed to Distributor, if any, as set forth in Appendix A hereto. Any official notice to Licensee, as required by this Agreement, shall be addressed to the contact person and address information ref lected on the invoice or purchase order for the GlycoCheck System. Each of the Parties shall be responsible for notifying the other, through distributor, if any, of any changes to the respective Party's contact information. All notices and other communications hereunder shall be given in writing and delivered: (a) by personal delivery, or by prepaid overnight or international courier service to the contact addresses as set forth in this Section 9.3, as modified from time to time; or (b) by facsimile to such facsimile number as maybe provided in writing by a Party. Notices are deemed given on receipt or attempted delivery, if receipt is refused.
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9.4. Attorney Fees. In any suit, proceeding or action to enforce any term, condition or covenant of this Agreement or to procure an adjudication or determination of the rights of the Parties, the prevailing Party shall be entitled to recover from the other Party, in addition to any award of costs or disbursements provided by statute, reasonable sums as attorney fees and costs and expenses in connection with such suit, proceeding or action, including appeal, which sums shall be included in any judgment or decree entered therein.
9.5. Injunctive Relief. Notwithstanding the foregoing, it is agreed that any breach of this Agreement by Licensee making any unauthorized use of the GlycoCheck System or engaging in any other conduct which could impair GLYCOCHECK US's Intellectual Property Rights in the GlycoCheck System will cause immediate and irreparable harm to GLYCOCHECK US. In the event of any such breach by licensee, GLYCOCHECK US shall be entitled to immediate and interim injunctive relief from any court of competent jurisdiction to restrain such unauthorized use or conduct, and to other injunctive relief as may be necessary to protect GLYCOCHECK US's Intellectual Property Rights.
9.6. Severability. If any one or more provisions of this Agreement shall be found to be illegal, invalid or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby and in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision of similar terms to the extent legally possible.
9.7. Headings. The paragraph headings used herein are for convenience and shall not be deemed to modify or construe the provisions hereof.
9.8. Counterparts. This Agreement may be executed in one or more counterpart copies, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.
9.9. Force Majeure. Neither Party shall be liable to the other Party for any delay or failure to perform any other services nor did obligations set forth in this Agreement due to cause beyond its reasonable control. Performance times shall be considered extended for a period of time equivalent to the time lost because of such delays.
10. DEFINITIONS
10.1. "Authorized Users" means those persons who are employed by or affiliated with Licensee who have access to use the GlycoCheck System.
10.2. "System Hardware" means the (1) personal computer on which is loaded the Software Product, and (2) the Video Microscope Camera, which are provided to Licensee as part of the GlycoCheck System pursuant to the terms and conditions of this Agreement.
10.3. "Documentation" means all user manuals, reference guides, brochures, installation manuals, specifications, release notes, error
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message manuals or other written documentation provided by GLYCOCHECK US pertaining to the installation, use, data f lows, features or performance of the Software Product.
10.4. "GlycoCheck System" means the combination of the System Hardware and the Software Product, collectively.
10.5. "Improvements" means and includes any improvements, modifications, or amendments to the Software Product, whether made by GLYCOCHECK US or any other party, or their respective employees, agents, or other representatives.
Product or Documentation made independently by GLYCOCHECK US and generally offered by GLYCOCHECK US.
10.13. "Unauthorized Product" means any product used in connection with the GlycoCheck System or a component thereof that is not provided by GLYCOCHECK US and/or through Distributor, if any, to Licensee, including, but not limited to, (i) consumables, such as video microscope camera lens covers or tips, (ii) replacement laptop components, such as batteries, and (iii) software updates, fixes, or upgrades, but shall not include customary laptop accessories, such as a keyboard or mouse.
10.6. "Intellectual Property Rights" means patent, application for patent and rights to patent (whether applied for or not), copyrights (whether registered or not), trademarks (whether registered or not), trade secrets, inventions, know-how, moral rights, ideas, processes, techniques, data, confidential information and all other proprietary rights that are embodied in any form of media.
10.14. "Distributor" means, for each territory, the company or individual indicated in Appendix A hereto.
10.15. "You" or "Your" means the person or company who is being licensed to use the GlycoCheck System in association with this Agreement.
10.7. "Maintenance and Support" shall mean ongoing maintenance and support as set forth in Section 6 hereof, and shall include all new versions, revisions, updates, temporary and permanent fixes or workarounds that may be necessary or appropriate to facilitate Licensee's use of the GlycoCheck System.
10.8. "Software Key" means the alphanumeric character string provided by GLYCOCHECK US to Licensee and used to enable use of the Software Product.
10.9. "Software Product" means the computer software program (in object code form and/or Source Code form), and forming part of the GlycoCheck System, and all associated procedural code, and all components thereof, including all Documentation, Updates, Upgrades, and all other software and documentation provided by GLYCOCHECK US to Licensee and/or through Distributor, if any, and all intellectual property rights therein.
10.10. "Source Code" means (i) the human-readable code making up the Software Product and all other software required for a reasonably skilled programmer to compile the machine-executable software code for such Software Product, including all required tools that are not commercially available on an off-the-shelf basis, and (ii) all related design charts, data f lows and other documentation related to the Software Product needed to maintain and understand the code of the Software Product and all other similar documentation that would assist a programmer in the maintenance of the Software Product.
SCHEDULE A
GlycoCheck System Options:
1. LAPTOP VERSION GlycoCheck System includes Laptop PC with the latest version of GlycoCheck Software installed, Video Microscope Camera, Carry Case, and User's manual. The system comes with a 3-year manufacturer's warranty (see section 7.3 of the Agreement).
2. DESKTOP VERSION GlycoCheck System includes Desktop All-inone PC with the latest version of GlycoCheck Software installed, Video Microscope Camera, and User's manual. The system comes with a 3-year manufacturer's warranty (see section 7.3 of the Agreement).
APPENDIX A
Territory Japan
Other than Japan
Distributor
Finggal Link Co., Ltd., a company organized under the laws of the Japan, having a place of business at 2-6-6, Motoasakusa, Taito-ku, Tokyo 111-0041, Japan.
GlycoCheck US LLC, a company organized and subsisting under the laws of Delaware, United States, with principal offices located at 7 South Lone Peak Drive Alpine, Utah 84004, U.S.A.
10.11. "Updates" means any and all fixes, patches, and corrections to, the Software Product or Documentation made independently by GLYCOCHECK US and made generally available by Licensor to
Licensee.
10.12. "Upgrades" means any enhancements, improvements, new releases, new versions and any material changes to the Software
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