CONDITIONS OF USE

By accessing or using the TrueBinding, Inc.’s website (the “Site”), you agree to be bound by these Conditions of Use. If you do not agree to these Conditions, you must immediately discontinue use of the Site.

AUTHORIZED USERS AND ELIGIBILITY

Access to this Site and the ability to purchase products through the Site are strictly limited to licensed physicians, healthcare providers, hospitals, clinics, pharmacies, and other entities legally authorized to obtain and administer investigational drugs under applicable federal and state laws.

By placing an order through the site, you represent and warrant that you are duly licensed, qualified, and authorized to obtain investigational drugs and that you will comply with all applicable laws, regulations, and professional standards.

INVESTIGATIONAL USE AND EXPANDED ACCESS PROGRAM

Products made available through this Site are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA) for commercial sale.

All products are provided solely pursuant to an FDA-authorized Expanded Access Program, in accordance with the Federal Food, Drug, and Cosmetic Act and applicable regulations, including 21 CFR Part 312.

Products obtained through this Site may only be used:

  • For patients approved under the applicable Expanded Access authorization;

  • In accordance with the applicable FDA authorization, protocol, and any required Institutional Review Board (IRB) approval; and

  • In full compliance with all applicable federal, state, and local laws and regulations.

NO MEDICAL ADVICE

TrueBinding, Inc does not provide medical advice, diagnosis, or treatment recommendations. All clinical decisions regarding patient eligibility, dosing, administration, monitoring, and treatment are made solely by the patient’s licensed healthcare provider within the context of a valid provider–patient relationship, who must exercise independent medical judgment.

PROVIDER RESPONSIBILITIES

By purchasing or using any product obtained through the Site, you agree that you are solely responsible for:

  • Obtaining and maintaining any required IRB approval or institutional authorization;

  • Ensuring proper informed consent is obtained and documented from patients;

  • Complying with all applicable FDA safety reporting and adverse event reporting requirements;

  • Maintaining complete, accurate, and legally required records; and

  • Using the investigational product strictly in accordance with the applicable Expanded Access protocol and authorization.

You acknowledge and agree that TrueBinding, Inc. is not responsible for any clinical, medical, or regulatory decision made by you or your institution.

PRICING, COST RECOVERY, AND NO RESALE

Any charges assessed for investigational products are intended solely to recover costs as permitted under applicable FDA regulations, unless otherwise expressly stated in writing.

Products obtained through the Site may not be resold, transferred, promoted, or distributed for any commercial purposes or used outside the authorized Expanded Access Program.

ACCOUNT SECURITY

Certain portions of the Site may require a username and password. You are responsible for maintaining the confidentiality of your account credentials and for all activities conducted under your account. TrueBinding, Inc. is not liable for any loss or damage arising from unauthorized use of your account.

TRADEMARKS

TrueBinding, Inc, TrueBinding™, and all related names, logos, and marks displayed on the Site are trademarks owned exclusively by TrueBinding, Inc. Use of these trademarks without express written permission is prohibited and may not be used in any manner that causes confusion, disparages TrueBinding, Inc, or suggests unauthorized affiliation.

COPYRIGHT

All content on this Site, including text, graphics, logos, images, audio, video, software, and digital materials, is the exclusive property of TrueBinding, Inc and is protected by U.S. and international copyright laws. All rights are reserved.

LICENSE AND SITE ACCESS

TrueBinding, Inc grants you a limited, non-exclusive, revocable, non-transferable and non-sublicensable license to access and use the Site for its lawful and intended purpose and strictly in accordance with these Terms and Conditions. Except as expressly permitted herein, you may not copy, modify, distribute, reproduce, create derivative works of, publicly display, publicly perform, republish, download, store, transmit, reverse engineer, scrape, frame, mirror, or otherwise exploit any content, materials, or functionality of the Site for any commercial purpose or otherwise without prior written consent from TrueBinding, Inc.

Any unauthorized use or access of the Site immediately terminates the license granted herein, without limiting any other rights or remedies available to TrueBinding, Inc.

CONTENT SUBMITTED BY USERS

If you submit content to the Site, you grant TrueBinding, Inc a nonexclusive, royalty-free, perpetual, irrevocable right to use, reproduce, modify, publish, and display such content in any media. You represent that you own or control all rights to the submitted content and that such content does not violate any law or third-party rights.

TrueBinding, Inc reserves the right to remove any submitted content at its sole discretion and without liability.

LIMITATION OF LIABILITY

The Site and all content are provided on an “as is” and “as available” basis. To the fullest extent permitted by law, TrueBinding, Inc disclaims all warranties, express or implied, including warranties of merchantability, fitness for a particular purpose, or non-infringement..

TrueBinding, Inc shall not be liable for any direct, indirect, incidental, consequential, or punitive damages arising from or related to your use of the Site or any products obtained through the Site, even if TrueBinding, Inc. has been advised of the possibility of such damages.

REGULATORY COMPLIANCE AND AUDIT COOPERATION

You agree to cooperate with TrueBinding, Inc in connection with any regulatory inquiries, audits, inspections, or reporting obligations related to the Expanded Access Program, including providing documentation reasonably requested by regulatory authorities. Failure to cooperate may result in termination of your access to the Site or the Expanded Access Program.

GOVERNING LAW

These Conditions of Use shall be governed by and construed in accordance with the laws of the State of California, without regard to conflict-of-law principles.

CHANGES TO CONDITIONS

TrueBinding, Inc reserves the right to modify or update these Conditions of Use at any time. Changes will be effective immediately upon posting on the site. Your continued use of the Site after such posting constitutes acceptance of the revised Conditions.