Terms of Use

PLEASE READ THESE TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS WEBSITE.

These terms of use describe the terms and conditions that apply to your use of the ZTlido Website (“Website”), owned by SCILEX Pharmaceuticals Inc. (“SCILEX”). By using this Website, you provide your acceptance of these Terms and Conditions. If you do not agree to all of these Terms and Conditions, please exit this Website.

SCILEX may modify this Website and the rules and regulations governing its use, at any time. Modifications may be posted on the Website. By continuing use of the Website after such changes are made, you will be accepting such changes.

This content of the website is intended to be a general information resource in regard to the subject matter covered but is provided solely on an “AS IS” and “AS AVAILABLE” basis as noted on this page. SCILEX is not engaged in rendering medical or other professional services or advice via this Website, and the information provided is not intended to replace medical advice offered by a physician. If you desire or need such services or advice, you should consult a professional healthcare provider. You should not construe SCILEX’s publication of this content as an endorsement by SCILEX of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content.

  1. Scope of Use: SCILEX will allow you to view, use, and download a single copy of this Website for your informational, noncommercial use. Except as otherwise provided herein, no part of any content or software on this Website may be copied, downloaded, or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of SCILEX. You understand that SCILEX may discontinue, change, or restrict your use of this Website for any reason without notice.

  2. No Warranties: ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN “AS IS” AND “AS AVAILABLE” BASIS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NONINFRINGEMENT. SCILEX MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. SCILEX MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES.

    THE ABOVE EXCLUSIONS MAY NOT APPLY IN JURISDICTIONS THAT DO NOT ALLOW THE EXCLUSION OF CERTAIN IMPLIED WARRANTIES.

  3. Limitation of Liability: YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. SCILEX SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF SCILEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS.

  4. Trademarks: The trademarks, logos, and service marks (collectively, the “trademarks”) displayed on this website are registered and unregistered trademarks of SCILEX and others. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the trademarks. Unauthorized use of any trademark may be a violation of federal and state trademark laws.

  5. User Submissions: Certain areas of this Website might enable you to access online forums and to submit e-mails, or otherwise provide feedback to SCILEX. SCILEX does not endorse, and specifically disclaims any responsibility or liability for any content in the forums. In addition, SCILEX reserves the right to delete, move, or edit content, in whole or in part, submitted to the forums that it, in its sole discretion, deems abusive, defamatory, obscene, in violation of intellectual property, privacy, or other proprietary rights, in violation of these terms and conditions, or for any other reason.

    You agree that by submitting content, you:

    • will only submit content related to the subject matter of the forum, if applicable, and that complies with applicable law, and will not submit content that is abusive, defamatory, obscene, infringing, threatening, repetitive, or otherwise inappropriate, or that contains any viruses or other software that may adversely affect the operation of another’s computer;

    • understand and agree that such content that is submitted to a forum, or feedback page, will be deemed non-confidential; and

    • grant to SCILEX the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with SCILEX’s Privacy Policy, and waive any moral rights you may have in such content. Subject to SCILEX’s Privacy Policy, SCILEX shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever

  6. Security: You are responsible for maintaining the confidentiality of your registration number and password, and you are responsible for all uses of your registration number or password, and any and all related charges, whether or not authorized by you.

  7. Location & Governing Law: This Website is operated by SCILEX from its offices in California, USA. The law of the State of California shall govern these terms and conditions, without reference to its choice of law rules. SCILEX makes no representation that the information in the Website is appropriate or available for use in other locations, and access to the SCILEX Website from territories where the content of the SCILEX Website may be illegal is prohibited. Those who choose to access the SCILEX Website from other locations do so on their own initiative and are responsible for compliance with applicable local laws.

  8. Violations & Additional Policies: SCILEX reserves the right to seek all remedies available at law and in equity for violations of the rules and regulations set forth in this Website, including the right to block access from a particular Internet address to the Website.

  9. Safe Harbor: Except for the historical information contained on this Website, the matters set forth in this Website and within its content, including statements regarding SCILEX’s plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development, and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with SCILEX’s operating performance and financial position, the market demand for and acceptance of SCILEX’s products domestically and internationally, research, development and commercialization of new products domestically and internationally, reliance upon the collaborative efforts of others, competition domestically and internationally, the success of external business-development activities, intellectual property rights, government regulation, obtaining and maintaining regulatory approvals domestically and internationally, government investigations, litigation, including, but not limited to SCILEX’s ability to protect its patents and other intellectual property both domestically and internationally, the occurrence of adverse safety events delay or failure to gain acceptance by the medical field domestically and internationally, dependence on third parties for supply, manufacturing and distribution, delay or failure to adequately build or maintain the necessary sales, marketing, supply chain management and reimbursement capabilities on our own or enter into arrangements with third parties to perform these functions in a timely manner or on acceptable terms, and other risks detailed from time to time in the Company’s most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

© 2018 SCILEX Pharmaceuticals Inc.
All rights reserved.

Important Safety Information

Contraindications

ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Warnings and Precautions

Accidental exposure can occur even after a ZTLIDO patch has been used. Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used ZTLIDO patch. Store and dispose of patches properly and keep out of reach of children and pets.

Excessive dosing or overexposure to lidocaine can occur. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine. If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Cases of methemoglobinemia have been reported with local anesthetic use, although patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, or concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. Signs and symptoms include cyanotic skin discoloration and/or abnormal coloration of the blood and may occur immediately or may be delayed after exposure. Methemoglobin levels may continue to rise leading to more serious central nervous system and cardiovascular adverse effects. Discontinue ZTLIDO and any other oxidizing agents. Depending on severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Application site reactions can occur during or immediately after treatment with ZTLIDO. This may include development of blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Inform patients of these potential reactions and that severe skin irritation may occur with ZTLIDO if applied for a longer period than instructed.

Hypersensitivity cross-reactions may be possible for patients allergic to PABA derivatives. Manage hypersensitivity reactions by conventional means.

Eye exposure with ZTLIDO should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye (eg, eye glasses/eye wear) until sensation returns.

Adverse Reactions

Side effects of ZTLIDO include application site reactions such as, irritation, erythema, and pruritus. These are not all of the adverse reactions that may occur. Please see full Prescribing Information for more information.

Use in Specific Populations

Use of ZTLIDO during lactation should be used with caution as lidocaine is excreted into breast milk. The limited human data with lidocaine in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage.

To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Important Safety Information

Contraindications

ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

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