Trial By Fire Solutions - SimpleCTMS

Terms of Service

Date of last revision: May 5, 2010

PLEASE READ THESE TERMS OF SERVICE CAREFULLY.

Welcome to the SimpleCTMS website and application from Trial By Fire Solutions, LLC.  This website located at www.simplectms.com is owned and operated by Trial By Fire Solutions, LLC (the "Company") in the United States.  SimpleCTMS is a technology platform that allows users to perform detailed clinical trial management activities for products being developed in the pharmaceutical, biotechnology and device industries.   The services offered by Trial By Fire Solutions include the SimpleCTMS website, content and application (the "Trial By Fire Solutions Website"), the Trial By Fire Solutions features, including, but not limited to: software tools to manage clinical trials, data uploading, data templates, and any other tools and services launched from time-to-time on the Trial By Fire Solutions Website (the "Trial By Fire Solutions Service")

YOU HAVE BEEN GIVEN AN ACCESS CODE AND A PASSWORD TO ACCESS THE TRIAL BY FIRE SOLUTIONS SERVICE.  BY ACCESSING THE TRIAL BY FIRE SOLUTIONS SERVICE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS DESCRIBED HEREIN AND ALL TERMS INCORPORATED BY REFERENCE.   IF YOU DO NOT AGREE TO ALL OF THESE TERMS, DO NOT USE THE TRIAL BY FIRE SOLUTIONS SERVICE.  YOU MUST BE 13 YEARS OF AGE OR OLDER TO USE THE TRIAL BY FIRE SOLUTIONS WEBSITE.  IF YOU ARE A USER SUBJECT TO THE TERMS OF A SEPARATE WRITTEN AGREEMENT, THE TERMS OF THE WRITTEN AGREEMENT ARE IN ADDITION TO ANY TERMS HEREIN.  TO THE EXTENT THAT THERE IS A CONFLICT BETWEEN THE TERMS HEREIN AND SUCH WRITTEN AGREEMENT, THE TERMS OF THE WRITTEN AGREEMENT PREVAIL.

These terms and conditions of use ("Terms of Service") apply solely to your access to, and use of, the Trial By Fire Solutions Service.  These Terms of Service do not alter in any way the terms or conditions of any other agreement you may have with the Company for products, services or otherwise.  If you are using the Trial By Fire Solutions Service on behalf of any entity, you represent and warrant that you are authorized to accept these Terms of Service on such entity's behalf, and that such entity agrees to indemnify you and Company for violations of these Terms of Service. 

Temporary Demo Users: If you are accessing the Trial By Fire Solutions Service for demonstration and evaluation, this Terms of Service and your access to the Trial By Fire Solutions Service will expire [14] days after you first access the Trial By Fire Solutions Service.

These Terms of Service apply to all users of the Trial By Fire Solutions Service, including those users who are accessing the Trial By Fire Solutions Service for demonstration and evaluation purposes and those users who are subject to the terms of a written agreement for the Trial By Fire Solutions Service with a registered account.  The Trial By Fire Solutions Website may contain links and pointers to Internet sites maintained by third parties ("Third-Party Sites") that are not owned or controlled by the Company.  The Company has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any Third-Party Sites.   In addition, the Company will not and cannot censor or edit the content of any Third-Party Site. 

The Company reserves the right to change or modify any of the terms and conditions contained in the Terms of Service or any policy or guideline of the Trial By Fire Solutions Service, at any time and in its sole discretion.  Any changes or modification will be effective immediately upon posting of the revisions on the Trial By Fire Solutions Website, and you waive any right you may have to receive specific notice of such changes or modifications.  By accessing the Trial By Fire Solutions Service and continuing to use the software tools and other products and services therein following the posting of changes or modifications to the Terms of Service will confirm your acceptance of such changes or modifications.  Accordingly, you should frequently review the Terms of Service and applicable policies from time-to-time to understand the terms and conditions that apply to your use of the Trial By Fire Solutions Website and/or the Trial By Fire Solutions Service.  If you do not agree to the amended terms, you must stop using the Trial By Fire Solutions Service and contact Trial By Fire Solutions, LLC at support@simplectms.com. 

Types of Service

Trial By Fire Solutions, LLC, has created a software product to facilitate the management and tracking of clinical trials in the pharmaceutical, biotechnology and device industries.  The software product and tools are hosted on the Trial By Fire Solutions Website which is only accessible through a standard username and password login to either registered users or users that would like a demonstration of the software product and tools for evaluation purposes.  The software product includes clinical study tracking tools (budgetary, regulatory, safety, data management, clinical progress details) and downloadable template documents designed specifically for the pharmaceutical, biotechnology and device client users.  The software product and the associated tools accessed via the Trial By Fire Website is referred to as the Trial By Fire Solutions Service throughout this Terms of Service.

Data Analysis

The Company may collect and analyze the data you post on the Trial By Fire Solutions Website through a registered account and your use of the Trial By Fire Solutions Service in order to tailor the Trial By Fire Solutions Service to better meet user needs.

User Accounts

There are two types of user accounts:  registered/licensed user accounts and user accounts established for demonstration and evaluation purposes.  In creating your account, you agree to (a) provide accurate, current and complete information about you as may be prompted by any registration forms on the Trial By Fire Solutions Website or offline ("Registration Data"); (b) maintain the security of your password and identification (i.e. do not share your unique username and password with unauthorized users); (c) maintain and promptly update the Registration Data, and any other information you provide to Company, to keep it accurate, current and complete; and (d) accept all risks of unauthorized access to the Registration Data and any other information you provide to Company.  You are responsible for all activity that occurs on your user account and it is solely your responsibility to keep your user account password secure.  You must notify the Company immediately of any breach of security or unauthorized use of your user account.  Although the Company will not be liable for your losses caused by any unauthorized use of your account, you may be liable for the losses of the Company or others that result from such unauthorized use.  In order to create an account, you must be 13 years of age or older.  By registering, you represent and warrant that you are 13 years of age or older and that all information you provide in the registration form is complete and accurate.

Unauthorized Use of Website

Without limiting the foregoing, you agree that you will not use the Trial By Fire Solutions Website to take any of the following actions:

1.       Defame, abuse, harass, stalk, threaten, or otherwise violate the legal right of others;

2.       Publish, post, upload, e-mail, distribute, or disseminate (collectively, "Transmit") any inappropriate, profane, defamatory, infringing, obscene, indecent, or unlawful content;

3.       Transmit files that contain viruses, corrupted files, or any other similar software or programs that may damage or adversely affect the operation of another person's computer, our sites, any software or hardware, or telecommunications equipment;

4.       Advertise or offer to sell any goods or services for any commercial purpose unless you have our written consent to do so;

5.       Transmit surveys, contests, pyramid schemes, spam, unsolicited advertising or promotional materials, or chain letters;

6.       Download any file that you know or reasonably should know cannot be legally obtained in such manner;

7.       Falsify or delete any author attributions, legal or other proper notices or proprietary designations or labels of the origin or the source of software or other material;

8.       Restrict or inhibit any other user from using and enjoying any public area within our sites;

9.       Collect or store personal information about other end users;

10.   Interfere with or disrupt our sites, servers, or networks;

11.   Impersonate any person or entity, including, but not limited to, a representative of the Company, or falsely state or otherwise misrepresent your affiliation with a person or entity;

12.   Forge headers or manipulate identifiers or other data in order to disguise the origin of any content transmitted through our sites or to manipulate your presence on our sites;

13.   Take any action that imposes an unreasonably or disproportionately large load on our infrastructure;

14.   Engage in any illegal activities.

Copyright and Limited License

Unless otherwise indicated, the Trial By Fire Solutions Website and all content and other materials on the Trial By Fire Solutions Website, including, without limitation, the Trial By Fire Solutions Service, the Company logo, and all designs, text, graphics, pictures, information, data, databases, tables, spreadsheets, software, sound files, other files and the selection and arrangement thereof (collectively, the "Site Materials") are the proprietary property of Company or its licensors or users and are protected by U.S. and international copyright laws.  With your user account access, you are granted a limited, non-sublicensable license to access and use the Trial By Fire Solutions Service either for demonstration and evaluation purposes or for the purposes set forth in a written agreement between Trial By Fire Solutions, LLC and you (or the party for which you are a representative, and accordingly, subject to the terms of such written agreement).  Such license is subject to these Terms of Service and does not include: (a) any resale of the Trial By Fire Solutions Service or the software product and tools accessed thereon; (b) the distribution, public performance or public display of any Site Materials, including the Trial By Fire Solutions Service or any software products or tools accessed, reviewed or used that is available from the Trial By Fire Solutions Website, (d) modifying or otherwise making any derivative uses of the Trial By Fire Solutions Service or any software products or tools accessed, reviewed or used that is available from the Trial By Fire Solutions Website; (e) use of any data mining, robots or similar data gathering or extraction methods; (f) downloading, other than as expressly permitted subject to the terms and conditions of a written licensing agreement you have (or the party for which you are a representative has) with the Company of any portion of the Trial By Fire Solutions Service, or any software product or tools accessed, reviewed or used that is available from the Trial By Fire Solutions Website, the Site Materials, or any information contained therein; or (g) any use of the Trial By Fire Solutions Service, software product or tools accessed, reviewed or used that is available from the Trial By Fire Solutions Website, or the Site Materials other than for its intended purpose.  Any use of the Trial By Fire Solutions Service, the software product or tools accessed, reviewed or used that is available from the Trial By Fire Solutions Website, or the Site Materials other than as specifically authorized herein, without the prior written permission of Company, is strictly prohibited and will terminate the license granted herein.  Such unauthorized use may also violate applicable laws including without limitation copyright and trademark laws and applicable communications regulations and statutes.  Unless explicitly stated herein, nothing in these Terms of Service shall be construed as conferring any license to intellectual property rights, whether by estoppel, implication or otherwise.  This license is revocable at any time.

The technology and the software underlying the Trial By Fire Solutions Website and the Trial By Fire Solutions Service is the property of the Company and our partners. You agree not to copy, modify, rent, lease, loan, sell, assign, distribute, reverse engineer, grant a security interest in, or otherwise transfer any right to the technology or software underlying the Trial By Fire Solutions Website or the Trial By Fire Solutions Service. You agree not to modify the software underlying the Trial By Fire Solutions Website or the Trial By Fire Solutions Service in any manner or form or to use modified versions of such software product or tools, including (without limitation) for the purpose of obtaining unauthorized access to the Trial By Fire Solutions Service sites.

Trademarks and Copyrights

Trial By Fire Solutions, SimpleCTMS, the Company logos and any other product or service name or slogan contained in the Trial By Fire Solutions Website are trademarks of Company and its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of Company or the applicable trademark holder.  You may not use any metatags or any other "hidden text" utilizing "Company" or any other name, trademark or product or service name of Company without our prior written permission.  In addition, the look and feel of the Trial By Fire Solutions Website and the Trial By Fire Solutions Service, including all page headers, custom graphics, reports, document templates, are the service mark, trademark,trade dress and/or copyright of Company and may not be copied, imitated or used, in whole or in part, without our prior written permission.  All other trademarks, registered trademarks, product names and company names or logos mentioned in the Trial By Fire Solutions Website or the Trial By Fire Solutions Service are the property of their respective owners.  Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier or otherwise does not constitute or imply endorsement, sponsorship or recommendation thereof by us.

Third-Party Claims

The Company does not permit copyright infringing activities and infringement of intellectual property rights on the Trial By Fire Solutions Website.  The Company will remove any material if properly notified that such material infringes on another's intellectual property rights.  The Company reserves the right to decide whether material is appropriate and complies with these Terms of Service for violations other than copyright infringement and violations of intellectual property law, such as, but not limited to, pornography, obscene or defamatory material, or excessive length. The Company may remove such material in violation of these Terms of Service at any time, without prior notice and at its sole discretion.

In particular, if you are a copyright owner or an agent thereof and believe that any material on the Trial By Fire Solutions Website or other content infringes upon your copyrights, you may submit a notification pursuant to the Digital Millennium Copyright Act ("DMCA") by providing the Company with the following information in writing (see 17 U.S.C 512(c)(3) for further detail):

(1)      a physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;

(2)      identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works at a single online site are covered by a single notification, a representative list of such works at that site;

(3)      identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled and information reasonably sufficient to permit the service provider to locate the material;

(4)      information reasonably sufficient to permit the service provider to contact you, such as an address, telephone number, and, if available, an electronic mail;

(5)      a statement that you have a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law; and

(6)      a statement that the information in the notification is accurate, and under penalty of perjury, that you are authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

Notifications of claimed infringement should be sent to support@simplectms.com.  You acknowledge that if you fail to comply with all of the requirements set forth above, your DMCA notice may not be valid.

We may give notice of a claim of copyright infringement to our users by means of a general notice on the Trial By Fire Solutions Website, electronic mail to a user's email address in our records, or by written communication sent by first-class mail to a user's address in our records. 

Repeat Infringer Policy

In accordance with the Digital Millennium Copyright Act (DMCA) and other applicable law, the Company has adopted a policy of terminating, in appropriate circumstances and at the Company's sole discretion, subscribers or account holders who are deemed to be repeat infringers.  The Company may also at its sole discretion limit access to the Trial By Fire Solutions Website and/or terminate the accounts of any users who infringe any intellectual property rights of others, whether or not there is any repeat infringement.

Export Control

The Trial By Fire Solutions Website is controlled, operated and offered by the Company from its offices within the State of California, United States of America. Unless otherwise specified, the materials on the Trial By Fire Solutions Website are presented solely to promote and provide information about Trial By Fire Solutions' products and services available in the United States. The Company makes no representation that the materials in the Trial By Fire Solutions Website are appropriate or available for use in other locations and other countries. Those who choose to access or use the Trial By Fire Solutions Website from other locations or other countries do so on their own initiative and are responsible for compliance with local laws in that territory, if and to the extent that local laws are applicable. Software available from the Trial By Fire Solutions Website is further subject to United States export controls.  No software from the Trial By Fire Solutions Website  may be downloaded or otherwise exported or re-exported: (A) into (or to a national resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria, or any other country to which the U.S. has embargoed goods, or (B) to anyone on the U. S. Treasury Department list of Specially Designated Nationals or the U.S. Commerce Department's Table of Deny Orders. By using the Trial By Fire Solutions Website, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.

Children Online Protection Act Notification.

Pursuant to 47 U.S.C. Section 230 (d) as amended, the Company hereby notifies you that parental control protections (such as computer hardware, software, or filtering services) are commercially available that may assist you in limiting access to material that is harmful to minors. Information identifying current providers of such protections is available at the GetNetWise website at http://kids.getnetwise.org/.

Indemnification

You agree to defend, indemnify and hold harmless the Company, its independent contractors, service providers and consultants, and their respective directors, employees and agents, from and against any claims, damages, costs, liabilities and expenses (including, but not limited to, reasonable attorneys' fees) arising out of or related to your use of the Trial By Fire Solutions Website, any software tools accessed thereon, or the Trial By Fire Solutions Service, including without limitation any actual or threatened suit, demand or claim made against the Company and/or its independent contractors, service providers, employees, directors or consultants, arising out of or relating to your conduct, your violation of these Terms of Service or your violation of the rights of any third party.

Disclaimer

EXCEPT AS EXPRESSLY PROVIDED TO THE CONTRARY IN A WRITING BY COMPANY, THE TRIAL BY FIRE SOLUTIONS WEBSITE, THE TRIAL BY FIRE SOLUTIONS WEBSITE MATERIALS CONTAINED THEREIN AND THE TRIAL BY FIRE SOLUTIONS SERVICE ARE PROVIDED ON AN "AS IS" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED.  THE COMPANY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT AS TO THE INFORMATION, CONTENT AND MATERIALS IN THE TRIAL BY FIRE SOLUTIONS WEBSITE.  THE COMPANY DOES NOT REPRESENT OR WARRANT THAT MATERIALS IN THE TRIAL BY FIRE SOLUTIONS WEBSITE OR THE TRIAL BY FIRE SOLUTIONS SERVICE ARE ACCURATE, COMPLETE, RELIABLE, CURRENT OR ERROR-FREE.  COMPANY DOES NOT REPRESENT OR WARRANT THAT THE TRIAL BY FIRE SOLUTIONS WEBSITE OR ITS SERVERS ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.  THE COMPANY IS NOT RESPONSIBLE FOR TYPOGRAPHICAL ERRORS OR OMISSIONS.  WHILE THE COMPANY ATTEMPTS TO MAKE YOUR ACCESS AND USE OF THE TRIAL BY FIRE SOLUTIONS WEBSITE AND THE TRIAL BY FIRE SOLUTIONS SERVICE SAFE, THE COMPANY CANNOT AND DOES NOT REPRESENT OR WARRANT THAT THE TRIAL BY FIRE SOLUTIONS WEBSITE OR ITS SERVER(S) ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS; THEREFORE, YOU SHOULD USE INDUSTRY-RECOGNIZED SOFTWARE TO DETECT AND DISINFECT VIRUSES FROM ANY DOWNLOAD.  The Company reserves the right to change any and all content contained in the Trial By Fire Solutions Website and any services or features offered through the Trial By Fire Solutions Website at any time without notice.  Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier or otherwise does not constitute or imply endorsement, sponsorship or recommendation thereof, or any affiliation therewith, by Company. 

Limitation of Liability

EXCEPT AS EXPRESSLY PROVIDED TO THE CONTRARY IN A WRITING BY COMPANY, IN NO EVENT SHALL THE COMPANY, ITS DIRECTORS, MANAGERS, MEMBERS, EMPLOYEES OR AGENTS BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, OR ANY OTHER DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO LOSS OF USE, LOSS OF PROFITS OR LOSS OF DATA, WHETHER IN AN ACTION IN CONTRACT, TORT (INCLUDING BUT NOT LIMITED TO NEGLIGENCE) OR OTHERWISE, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF OR INABILITY TO USE THE TRIAL BY FIRE SOLUTIONS WEBSITE, THE TRIAL BY FIRE SOLUTIONS SERVICE, THE CONTENT OR THE MATERIALS CONTAINED IN OR ACCESSED THROUGH THE TRIAL BY FIRE SOLUTIONS WEBSITE OR THE TRIAL BY FIRE SOLUTIONS SERVICE, INCLUDING WITHOUT LIMITATION ANY DAMAGES CASED BY OR RESULTING FROM RELIANCE BY USER ON ANY INFORMATION OBTAINED FROM COMPANY, OR THAT RESULT FROM MISTAKES, OMISSIONS, INTERRUPTIONS, DELETION OF FILES OR EMAIL, ERRORS, DEFECTS, VIRUSES, DELAYS IN OPERATION OR TRANSMISSION OR ANY FAILURE OF PERFORMANCE, WHETHER OR NOT RESULTING FROM ACTS OF GOD, COMMUNICATIONS FAILURE, THEFT, DESTRUCTION OR UNAUTHORIZED ACCESS TO COMPANY'S RECORDS, PROGRAMS OR SERVICES. 

IN NO EVENT SHALL THE AGGREGATE LIABILITY OF COMPANY, WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE, WHETHER ACTIVE, PASSIVE OR IMPUTED), PRODUCT LIABILITY, STRICT LIABILITY OR OTHER THEORY, ARISING OUT OF OR RELATING TO THE USE OF OR INABILITY TO USE THE TRIAL BY FIRE SOLUTIONS WEBSITE OR THE TRIAL BY FIRE SOLUTIONS SERVICE EXCEED ANY FEES YOU PAY, IF ANY, TO COMPANY FOR ACCESS TO OR USE OF THE TRIAL BY FIRE SOLUTIONS WEBSITE OR THE TRIAL BY FIRE SOLUTIONS SERVICE. 

Applicable Law and Venue

These Terms of Service and your use of the Trial By Fire Solutions Website shall be governed by and construed in accordance with the laws of the State of California, applicable to agreements made and to be entirely performed within the State of California, without resort to its conflict of law provisions.  With respect to any disputes or claims not subject to arbitration, you agree that any action at law or in equity arising out of or relating to these Terms of Service shall be filed only in the state and federal courts located in Alameda County, California and you hereby irrevocably and unconditionally consent and submit to the exclusive jurisdiction of such courts over any suit, action or proceeding arising out of these Terms of Service.

Ability to Accept Terms of Service.

You affirm that you are 18 years of age or older, or an emancipated minor, or possess legal parental or guardian consent, and are fully able and competent to enter into the terms, conditions, obligations, affirmations, representations, and warranties set forth in these Terms of Service, and to abide by and comply with these Terms of Service. In any case, you affirm that you are over the age of 13, as the Trial By Fire Solutions Website   is not intended for children under 13. IF YOU ARE UNDER 13 YEARS OF AGE, THEN PLEASE DO NOT USE THE TRIAL BY FIRE SOLUTIONS WEBSITE.

Termination

Notwithstanding any of these Terms of Service, Company reserves the right, without notice and in its sole discretion, to terminate your right to use the Trial By Fire Solutions Website and the Trial By Fire Solutions Service, and to block or prevent future your access to and use of the Trial By Fire Solutions Website and the Trial By Fire Solutions Service.  Company also reserves the right to discontinue the Trial By Fire Solutions Website and the Service, or any features thereof, at any time without notice. 

Licensed users should refer to the written license terms regarding Termination, as a grace period is typically extended to allow for transition and data export into standard formats. 

Evaluation users are solely responsible for creating backup copies of and replacing any data you post or store on the Trial By Fire Solutions Website at your sole cost and expense.

Severability

If any provision of these Terms of Service shall be deemed unlawful, void or for any reason unenforceable, then that provision shall be deemed severable from these Terms of Service and shall not affect the validity and enforceability of any remaining provisions.

Contact Information

Please direct any comments or questions for the Company to support@simplectms.com or 510-761-5515.

I HAVE READ THESE TERMS OF USE AND AGREE TO ALL OF THE PROVISIONS CONTAINED ABOVE.