Terms of Use

Acceptance of Terms

 

The following terms and conditions govern all use of the www.genelux.com (the “Site”). The Site is offered subject to acceptance without modification of any of the terms and conditions contained herein or all other operating rules, policies and procedures that may be published or amended from time to time on this Site by Genelux, Inc. (collectively, the Terms of Use). IF YOU DO NOT AGREE TO ALL OF THESE TERMS OF USE, THEN DO NOT ACCESS OR USE THE SITE. BY VIEWING THE SITE, YOU AGREE TO BE BOUND BY ALL OF THESE TERMS OF USE.

 

Changes

 

Genelux Corporation (“Genelux”) reserves the right, at its sole discretion, to modify or replace any of these Terms of Use at any time without notice. It is your responsibility to check the Terms of Use periodically for changes. Your continued use of the Site following the posting of any changes to the Terms of Use constitutes acceptance of those changes.

 

Information and privacy

 

At your election, you may request (and Genelux may provide) additional information about Genelux. When you do so, you may need to submit certain information or data to Genelux, for example, your contact information. Genelux’ current privacy policy is available at the “Privacy Policy”, which is incorporated by this reference.

 

Rules and conduct

 

As a condition of use, you promise not to use the Site for any purpose that is unlawful or prohibited by these Terms of Use, or any other purpose not reasonably intended by Genelux. You agree to abide by all applicable local, state, national laws. This Site is based in the United States. Genelux makes no claims concerning whether the Content may be downloaded, viewed, or be appropriate for use outside of the United States. If you access the Website or the Content from outside of the United States, you do so at your own risk. Whether inside or outside of the United States, you are solely responsible for ensuring compliance with the laws of your specific jurisdiction.”

 

Use of Site information

 

The Site may contain forward-looking statements and information relating to Genelux that are based on its beliefs, as well as assumptions based on information currently available to it. The words “anticipate,” “believe,” “estimate,” “expect,” “goal,” “intend,” “potential,” “will,” and similar expressions, as they relate to Genelux, are intended to identify forward-looking statements. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond Genelux’ control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Genelux assumes no obligation to update these forward-looking statements, and such statements are current only as of the date they are made.

 

Third-party sites

 

The Site may permit you to link to other websites on the Internet, and other websites may contain links to the Site. These other websites are not under Genelux’ control, and you acknowledge that Genelux is not responsible for the accuracy, legality, appropriateness or any other aspect of the content or function of such websites. The inclusion of any such link does not imply endorsement by Genelux or any association with its operators.

 

Proprietary rights

 

You agree that all content and materials delivered via the Site and Genelux or otherwise made available by Genelux at the Site are protected by copyrights, trademarks, service marks, patents, trade secrets or other proprietary rights and laws. Except as expressly authorized by Genelux in writing, you agree not to sell, license, rent, modify, distribute, copy, reproduce, transmit, publicly display, publicly perform, publish, adapt, edit or create derivative works from such materials or content. It is the policy of Genelux to enforce its intellectual property rights to the fullest extent permitted under law. The use or misuse of these trademarks, copyrights, or other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, communications regulations and statutes, and other laws, statutes, and/or regulations. However, you may print or download a reasonable number of copies of the materials or content at this Site for your internal business purposes provided that you retain all copyright and other proprietary notices contained therein.

 

No warranties

 

THE SITE AND ALL MATERIALS, INFORMATION, SOFTWARE, PRODUCTS AND SITES INCLUDED IN OR AVAILABLE THROUGH THE SITE (THE CONTENT) ARE PROVIDED “AS IS” AND “AS AVAILABLE.” THE SITE, SERVICE AND CONTENT ARE PROVIDED WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY WARRANTIES IMPLIED BY ANY COURSE OF PERFORMANCE OR USAGE OF TRADE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. GENELUX AND ITS AFFILIATES, LICENSORS AND SUPPLIERS DO NOT WARRANT THAT: (1) THE CONTENT IS TIMELY, ACCURATE, COMPLETE, RELIABLE OR CORRECT; (2) THE SITE WILL BE SECURE OR AVAILABLE AT ANY PARTICULAR TIME OR LOCATION; (3) ANY DEFECTS OR ERRORS WILL BE CORRECTED; (4) THE CONTENT IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS; OR (5) THE RESULTS OF USING THE SITE OR SERVICE WILL MEET YOUR REQUIREMENTS. YOUR USE OF THE SITE AND/OR SERVICE ARE SOLELY AT YOUR OWN RISK.

 

Limitation of liability

 

IN NO EVENT SHALL ANY GENELUX PARTY (OR ITS AFFILIATES, LICENSORS AND SUPPLIERS) BE LIABLE CONCERNING THE SUBJECT MATTER OF THESE TERMS OF USE, REGARDLESS OF THE FORM OF ANY CLAIM OR ACTION (WHETHER IN CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE), FOR ANY (1) MATTER BEYOND ITS REASONABLE CONTROL, (2) LOSS OR INACCURACY OF DATA, LOSS OR INTERRUPTION OF USE, OR COST OF PROCURING SUBSTITUTE TECHNOLOGY, GOODS OR SITES, OR (3) DIRECT OR INDIRECT, PUNITIVE, INCIDENTAL, RELIANCE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOSS OF BUSINESS, REVENUES, PROFITS OR GOODWILL, EVEN IF GENELUX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS ARE INDEPENDENT FROM ALL OTHER PROVISIONS OF THIS AGREEMENT AND SHALL APPLY NOTWITHSTANDING THE FAILURE OF ANY REMEDY PROVIDED HEREIN.

 

Miscellaneous

 

These Terms of Use shall be governed by and construed in accordance with the laws of the State of California, excluding its conflicts of law rules. You agree that any claim, cause of action, or dispute between us that arises out of or relates to these Terms of Use shall be resolved exclusively in the U.S. District Court for the Southern District of California or a state court located in Ventura County. You also agree to submit to the personal jurisdiction of either of these courts for the purpose of litigating any such claim. If any provision of the Terms of Use is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary so that the Terms of Use will otherwise remain in full force and effect and enforceable. Genelux may assign, transfer or delegate any of its rights and obligations hereunder without consent. All waivers and modifications must be in a writing signed by Genelux, except as otherwise provided herein. No agency, partnership, joint venture, or employment relationship is created as a result of these Terms of Use, and neither party has any authority of any kind to bind the other in any respect.

 

Unless otherwise indicated, these Terms of Use and all content provided by Genelux are copyright © 2022 Genelux Corporation. All rights reserved. Genelux and the Genelux logo are trademarks of Genelux. The names of actual companies and products mentioned at the Site may be the trademarks of their respective owners.

Expanded Access Policy

Genelux Corporation is committed to developing safe and effective next-generation immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Genelux, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.

The request for access to a Genelux investigational drug will be considered only if the patient is an eligible patient, meaning:

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies; and
  • The patient is not eligible for or unable to participate in a clinical trial

In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:

  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition;
  • Providing the investigational therapy as part of an expanded access program will interfere with clinical trials that could support the investigational therapy’s development or marketing approval for the treatment indication; and
  • We have adequate supply of investigational drug.

At this time, based on these factors, Genelux believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies.

If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.

Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.

The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.

For more information on expanded access from the FDA, click here.