Treace Medical Concepts
Effective September 1, 2021
PLEASE READ THE FOLLOWING TERMS CAREFULLY.
IF YOU ARE NOT ELIGIBLE OR DO NOT AGREE TO THIS AGREEMENT, THEN YOU DO NOT HAVE OUR PERMISSION TO USE THE WEBSITES OR TREACE PRODUCTS. YOUR USE OF THE WEBSITES OR TREACE PRODUCTS CONSTITUTES AN AGREEMENT BY YOU TO BE BOUND BY THIS AGREEMENT.
- Scope of this Agreement
1.1 Treace does not provide medical or healthcare services. You acknowledge that Treace is a medical device manufacturer, not a healthcare provider, and does not engage in the practice of medicine or provide medical, health or other professional services or advice. Information contained on the Websites is general educational information only and is not a substitute for receiving proper medical care and advice from your physician, and you agree that you are solely responsible for obtaining proper diagnosis, treatment and advice from your physician. Only your physician can determine if the Lapiplasty® procedure is right for you.
1.2 Additional terms apply to your use of the Websites. In addition to the terms set forth in this Agreement, any other terms and conditions that we post or make available through the Websites or otherwise make available to you, apply to your use of the Websites and are incorporated into and made a part of this Agreement. These additional terms include (but are not limited to) the following:
- any description located on our Websites;
- third-party copyright and other notices located on our Websites;
- Treace copyright, trademark and patent notices located on our Websites;
- any terms in any documentation provided to you by Treace, including (without limitation) in any manuals, packaging, instructions for use, indications for use, contraindications, and product warnings and safety statements (“Treace Product Labeling”);any consent or authorization you sign in connection with your use of Treace Products; and
1.3 Use of Websites and Treace Products Outside of the United States. The Websites and Treace Products are intended solely for use in the United States of America, and the Websites are not intended to subject Treace to any jurisdiction or law other than as provided by Section 5 below. The Websites are not intended to and will not be construed as an offer to sell, market, distribute, or use Treace Products outside of the United States of America.
1.4 Questions regarding Treace Products and contacting a doctor. If you have undergone the Lapiplasty® procedure and have questions concerning your implant, please contact your surgeon. If you are a patient and have general questions regarding Treace Products and the Lapiplasty® procedure or wish to contact a doctor you have selected using the Find a Lapiplasty® doctor tool, please contact the Lapiplasty® Patient Call Center at 1-800-363-4145. The Lapiplasty® Patient Call Center, which is operated by our contractor (currently Sequence Health LLC) and assists with patient education and appointment scheduling, does not dispense medical advice.
2. Changes to the terms of this Agreement and to the Websites. Unless prohibited by applicable law, Treace can change the terms of this Agreement by notifying you of such changes by any reasonable means, including by posting new versions of this Agreement to our Websites. You are responsible for periodically reviewing this Agreement for changes. Your use of the Websites after we post a new version of this Agreement constitutes your acceptance of it. We reserve the right to change the Websites and their features or functionalities.
3. Use of Websites
3.1 Intended use of the Websites. The Websites are intended to provide information to existing and potential patients who are interested in or have had the Lapiplasty® Procedure, to physicians and other healthcare providers who may purchase Treace Products or perform the Lapiplasty® procedure, to suppliers and contractors of Treace, to existing or potential investors in Treace, and to other Users of this Website. The Websites are not intended for use by any person or entity that manufactures, distributes, or sells any products or services that compete with any Treace Product and are not intended for use by any User for commercial purposes.
3.2 Surgeon Portal. The Surgeon Portal portion of the Websites is intended for use by podiatrists, orthopedic surgeons and related healthcare providers only, subject to their acceptance of this Agreement. Any information provided within the Surgeon Portal is provided by Treace as an information service to healthcare providers. Material downloaded from the Surgeon Portal may be used by you for personal, non-commercial purposes only. Approved purposes include clinical education of professional staff in your practice and patients, downloading of forms to facilitate order fulfillment, and review of technique aids, clinical data presentations, journal publications, and design rationales in preparation for your care of patients. You may not distribute, modify, transmit, reuse, report or use any of such materials for public or commercial purposes or provide such materials to an employee of any competitor of Treace, without Treace’s express written permission. All copyright and other proprietary notices contained in the downloaded materials must be retained.
3.3 Sales Portal. The Sales Portal is intended for use by existing independent and employee sales representatives of Treace only. Any information provided within the Sales Portal is provided by Treace on a confidential basis for the purposes of assisting sales representatives in performing their obligations to Treace and its customers. Any information provided, or communications from Treace representatives, on the Sales Portal will not be deemed to supersede any executed purchase order or other negotiated terms concerning the sale of Treace Products. You may not distribute, modify, transmit, reuse, report or use any of such materials other than for the benefit of Treace or provide such materials to a competitor of Treace, without Treace’s express written permission. Furthermore, you may not provide or distribute documents available through the Sales Portal to customers or other third parties unless it is clear that Treace intends for you to make the document available to customer or third parties. All copyright and other proprietary notices contained in the downloaded materials must be retained.
3.4 Patient Portal. The Patient Portal portion of the Websites is intended for use by bunion sufferers and other members of the general public, subject to their acceptance of this Agreement. Any information provided within the Patient Portal is provided by Treace as an information service to persons who may be interested in the Lapiplasty® Procedure and other TMC Products. Material downloaded from the Patient Portal may be used by you for personal, non-commercial purposes only. You may not distribute, modify, transmit, reuse, report or use any of such materials for public or commercial purposes or provide such materials to an employee of any competitor of Treace, without Treace’s express written permission. All copyright and other proprietary notices contained in the downloaded materials must be retained.
Otherwise, all communications and information will be considered non-confidential, and Treace will be free to reproduce, publish or otherwise use such information for any purpose whatsoever, including, without limitation, commercially exploiting such information, copying and publishing it, creating derivative works, or utilizing such information in the research, development, manufacture, use or sale of products or services incorporating such information. If you choose to provide proposed modifications or improvements, suggestions, comments, ideas or questions about the Websites or Treace Products or other matters (collectively, “Feedback”), then you hereby grant Treace an unrestricted, perpetual, irrevocable, non-exclusive, world-wide, fully-paid, royalty-free right and license to use and exploit the Feedback in any manner and for any purpose, including to improve Treace Products or Websites and create other products and services.
3.7 Third-party requirements. The Websites and Treace Products may include items licensed to us by third parties. Your use of any such third-party items is subject to the provisions of this Agreement and the terms of any license agreement entered into between Treace and such third-party, except as required otherwise by the applicable licensor. You must comply with the additional license provisions required by vendors of such third-party items posted by us on our Websites or which we otherwise provide or make available to you, as they are amended by us from time to time. The versions of such license provisions that are applicable to your use are incorporated into and made a part of this Agreement. Without limiting the provisions of this Agreement or expanding the scope of Treace’s responsibilities, Treace is not responsible for outages or defects in power, telecommunications, computers, smart devices, and any other event outside of Treace’s reasonable and direct control.
3.8 Age for use of the Websites and Treace Products. By agreeing to this Agreement, you are representing that you are the age of majority of the state and country in which you reside and have the legal capacity to enter into this Agreement.
3.9 Restrictions on your use of the Websites. By using the Websites, you agree that you will not, and you will not permit anyone under your control to:
- use the Websites or any Treace Products other than for their intended purpose, including for commercial purposes or to benefit any third party;
- collect, store or use information about other Users or specific transactions other than for the specific purpose for which that information was provided;
- disrupt, modify, reroute, obtain unauthorized access to, or intercept electronic information posted on, processed, or transmitted by the Websites or our servers;
- post, email or otherwise transmit any information known to be inaccurate;
- impersonate any person or entity or misrepresent or forge your identity, professional credentials, or affiliation with a person or entity, including using another person’s email, phone, password, other account information or identifiers, or another person’s or entity’s name, voice, or image;
- harm, threaten, or harass any person or entity or act in an unreasonable or unprofessional manner;
- violate any applicable local, state, national or international law, rules, or regulations, including the intellectual property rights of any person;
- damage, degrade, disrupt, disable, overburden, interfere with or impair the Websites, their integrity and performance (or any network or device connected to the Websites or any of their security features), including disrupting the normal flow of dialogue on the Websites and circumventing our administrative, technical or physical security measures;
- enable unauthorized third parties or third-party applications or hardware to access or modify the Websites, including using any automated process or service (such as a bot, a spider, periodic caching of information, or malicious code) to access or use the Websites;
- sublicense or transfer any of your rights under this Agreement or sell, resell, license, sublicense, distribute, rent or lease any part of the Websites;
- modify, copy or make derivative works based on the Websites or Treace Products or decompile, reverse engineer, or disassemble the Websites, including replicating or building a competitive product or service to Treace or that is injurious to Treace’s interests; or
- create Internet “links” to or from the Websites or “frame” or “mirror” any content which forms part of the Websites.
3.10 Assurance to Treace. You represent, warrant and agree that all information you provide to us will be true, accurate, current and complete, and you will only use the Websites for your personal benefit in accordance with this Agreement.
4. Suspension and Termination of Access. Access to the Websites may be interrupted or unavailable from time to time. Treace has the right to modify, suspend or terminate the Websites or your access to them for any reason. You may terminate your use of the Websites by ceasing to use them.
5. Disputes and Governing Law
5.1 Jurisdiction for Disputes. To the maximum extent permitted by applicable law, all disputes arising out of or related to this Agreement or any aspect of the relationship between you and Treace, whether based in contract, tort, statute, fraud, misrepresentation, or any other legal theory (each, a “Dispute”), shall be resolved exclusively in the federal and state courts located in Jacksonville, Florida, and you and Treace each waive any jurisdictional, venue or inconvenient forum objections to such courts.
5.2 Governing law. Except to the extent prohibited by applicable law, the terms of this Agreement and any Dispute between Treace and any User are governed by the laws of the State of Florida, U.S.A., without regard to its principles of conflicts of law and regardless of your location.
5.3 Notice of dispute. If there is a Dispute, the disputing party must provide the other party with written notice of the dispute, including the facts giving rise to the Dispute and the relief sought by the disputing party. If we have your email address, we will provide such notice by email to your email address. You will provide us with any notice required hereunder by mail or overnight delivery to the following address: Attn. Chief Legal Officer, Treace Medical Concepts, Inc., 230 Fort Wade Road, Suite 150, Ponte Vedra, Florida 32081, United States.
5.4 Equitable Relief. Any violation of a party’s intellectual property rights will cause the non-violating party irreparable harm for which monetary damages are an inadequate remedy, and the non-violating party is entitled to temporary, preliminary and permanent injunctive relief and specific performance without the posting of bond or other security, or if required, the minimum bond or security required.
6. Warranties and Disclaimers
6.1 Warranty Limitations. EXCEPT TO THE EXTENT REQUIRED BY APPLICABLE LAW, AND EXCEPT FOR ANY LIMITED WARRANTY INCLUDED IN THE APPLICABLE TREACE PRODUCT’S LABELING, TREACE PRODUCTS AND THE WEBSITES (INCLUDING THE INFORMATION IN THE WEBSITES) ARE PROVIDED “AS-IS” AND ON AN “AS AVAILABLE” BASIS WITHOUT ANY WARRANTY, EXPRESS OR IMPLIED, AND YOUR USE OF THE WEBSITES AND TREACE PRODUCTS IS AT YOUR OWN RISK.
- TREACE DOES NOT MAKE ANY WARRANTIES
(1) THAT TREACE PRODUCTS OR THE WEBSITES WILL MEET YOUR REQUIREMENTS, BE RETRIEVABLE, UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE OR THAT ALL ERRORS WILL BE CORRECTED;
(2) AS TO THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE WEBSITES OR TREACE PRODUCTS,
(3) AS TO ANY THIRD-PARTY WEBSITE, DEVICE, OR PRODUCT THAT YOU MAY USE IN CONNECTION WITH THE WEBSITE OR TREACE PRODUCTS,
(4) WITH RESPECT TO THE INFORMATION OR CONTENT POSTED ON THE WEBSITES, OR
(5) THAT INFORMATION PROVIDED BY ANY CUSTOMER WILL BE FREE FROM INTERCEPTION OR UNAUTHORIZED ACCESS.
TREACE HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUIET ENJOYMENT, ACCURACY, OPERATION, COMPLIANCE WITH DOCUMENTATION, TITLE OR NON-INFRINGEMENT.
6.2 Sole and Exclusive Remedy. IF YOU ARE DISSATISFIED WITH ANY PORTION OF THE WEBSITES, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE THEIR USE.
6.3 Third party commentary and patient stories. Any individuals or healthcare providers whose comments regarding Treace Products are contained on the Websites, including in any descriptions, explanations, FAQs, brochures, webinars, archives, blogs, news, or studies of Treace Products, may or may not be paid consultants of Treace. The inclusion of a testimonial or story on the Websites is not an endorsement, recommendation, or prediction from Treace that you will obtain any particular outcome. Your results from Lapiplasty® may differ from the results portrayed in patient testimonials and/or stories contained on the Websites. Treace is not responsible, and will not be liable, to you or others for any decision you make, or action you take, in reliance on the information obtained from the Websites. Your decision to undergo surgery with the Lapiplasty® Procedure is an important decision and should be based on your own investigation of, and consultation with, your own physician, including review of the Patient Risk Information on the Websites.
6.4 The “Find A Doctor” tool. Choosing a physician is an important decision and should be based on your own investigation of a particular physician’s education, training, and experience. The Websites include a Find A Doctor tool for locating physicians who have surgical experience with performing the Lapiplasty® Procedure. The underlying database may not include all physicians that use, or have used, Treace Products. Listed surgeons have performed a Lapiplasty® procedure in the last 6 months and completed a Lapiplasty® System training course, have not paid a fee to be listed, are identified by their geographic proximity to the location you enter, and may or may not be paid consultants of Treace. Treace is not recommending that you utilize any particular surgeon, and you should make an independent determination regarding the qualifications and suitability of a surgeon and any Treace Product.
Some surgeons may represent that they perform the Lapiplasty® Procedure, but with “alternative instrumentation and implants”. Don’t risk your health, ask your surgeon if they are using the Lapiplasty® System manufactured and patented by Treace. If they are not, then they are not performing Lapiplasty® 3D Bunion Correction™.
6.5 Product Discontinuation. Treace reserves the right to discontinue the sale of any Treace Product listed on the Websites at any time without notice.
7. Liability Limitations and Your Responsibility
7.1 No Warranty. Treace does not assume any liability for the materials, information and opinions provided on, posted to, or otherwise available through, this Websites. Reliance on these materials, information and opinions is solely at your own risk. The opinions of healthcare professionals contained on the Website are their own opinions, not the opinion of Treace. Information contained on the Website is provided as-is, without any warranty, except as required by law. Treace disclaims any liability for injury or damages resulting from the use of the Websites, or the content contained thereon.
7.2 Limitations of Liability. TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW, NEITHER TREACE, NOR ITS AFFILIATES, LICENSORS, SUPPLIERS AND OTHER THIRD PARTIES WITH WHICH TREACE HAS A CONTRACTUAL RELATIONSHIP, NOR ITS OR THEIR OFFICERS, DIRECTORS, EMPLOYEES, CONSULTANTS, AGENTS, OR SUPPLIERS (COLLECTIVELY, “TREACE PARTIES”) WILL BE LIABLE FOR (1)ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT), CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE WEBSITES AND/OR THE INFORMATION OR CONTENT POSTED ON THE WEBSITES, REGARDLESS OF WHETHER TREACE HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES, AND EVEN IF SUCH EXCLUSIONS CAUSE THIS AGREEMENT OR ANY REMEDY TO FAIL OF ITS ESSENTIAL PURPOSE OR (2) THE ACTIONS OR OMISSIONS OF A USER OR ANY THIRD PARTY. TO THE EXTENT THAT THE FOREGOING LIMITATION IS NOT APPLICABLE OR IS PROHIBITED UNDER APPLICABLE LAW, NONE OF THE TREACE PARTIES WILL BE LIABLE FOR TOTAL DAMAGES FOR ALL CLAIMS ARISING FROM OR RELATING TO THIS AGREEMENT, AND/OR THE WEBSITES IN AN AGGREGATE AMOUNT GREATER THAN $500.
7.3 Limitations in Certain Jurisdictions. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES OR THE LIMITATION OR EXCLUSION OF LIABILITY FOR CERTAIN DAMAGES. ACCORDINGLY, SOME OF THE ABOVE LIMITATIONS AND DISCLAIMERS (INCLUDING, WITHOUT LIMITATION, THOSE SET OUT IN SECTIONS 6 and 7) MAY NOT APPLY TO YOU, AND YOU MAY HAVE CERTAIN ADDITIONAL RIGHTS. TO THE EXTENT THAT WE MAY NOT, AS A MATTER OF APPLICABLE LAW, DISCLAIM ANY IMPLIED WARRANTY OR LIMIT OUR LIABILITIES, THE SCOPE AND DURATION OF SUCH WARRANTY AND THE EXTENT OF OUR LIABILITY WILL BE THE MINIMUM PERMITTED UNDER SUCH APPLICABLE LAW, AND THIS AGREEMENT WILL BE DEEMED MODIFIED TO THE MINIMUM EXTENT NECESSARY TO COMPLY WITH SUCH APPLICABLE LAW.
7.4 Exclusions from Limitations. Notwithstanding Paragraphs 7.1 through 7.3 above, nothing in this Section 7 is intended to limit or exclude liability where such liability is mandatory under applicable law and arises from the following: (a) death or personal injury resulting directly from willful or negligent act(s) or omission(s) by Treace or any of its employees or agents; or (b) any fraudulent misrepresentation on the part of Treace.
7.5 Your Responsibility. Except to the extent prohibited under applicable law, you agree to indemnify, defend and hold harmless the Treace Parties from and against any and all third-party claims, liabilities, damages, losses, costs, expenses, fees (including reasonable attorneys’ fees and court costs) that such parties may incur as a result of or arising from (1) any information you submit, post or transmit through the Websites or to us, (2) your use of Treace Products, (3) your violation of this Agreement, or (4) your violation of any rights of any other person or entity.
8. Notices; Questions or Complaints. Except as expressly provided elsewhere in this Agreement or as required by law, we will provide you with any notice required under this Agreement by posting the notice on the Websites. You are required to provide Treace with any notice required under this Agreement by mail or overnight delivery to the following address: Attention: Chief Legal Officer, Treace Medical Concepts, Inc., 230 Fort Wade Road, Suite 150, Ponte Vedra, Florida 32081, United States. If you have a question or complaint regarding the Websites, please send an e-mail to us at email@example.com or call us at (855) 673-3300. If you have a complaint or concern regarding any Treace Products, please send an e-mail to us at firstname.lastname@example.org, or call us at 904-373-5940. Please note that e-mail communications will not necessarily be secure. Accordingly, you should not include credit card information or other sensitive information in your e-mail correspondence with us.
9. Severability. If a court of competent jurisdiction finds that any provision of this Agreement is invalid or unenforceable, you agree that such provision will be modified to the minimum extent necessary to be effective, valid and enforceable while preserving the original intentions of the parties to the greatest extent possible, and the other provisions of this Agreement will remain in full force and effect and enforceable according to their terms.
10. Relationship; No Third-Party Beneficiaries. Our relationship with you is as an independent contractor, and nothing in this Agreement creates an agency or partnership. Except for Treace’s licensors, the Treace Parties, and the service provider for the Patient Call Center (currently Sequence Health), there are no third-party beneficiaries to this Agreement.
11. Forward-Looking Statements. The Websites may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and subject to the safe harbor created by the Securities Litigation Reform Act of 1995. Such statements include declarations regarding Treace’s intent, belief, or current expectations and those of Treace’s management. Any such forward-looking statements are not guarantees of future performance and involve a number of risks, uncertainties and other factors, some of which are beyond Treace’s control; actual results could differ materially from those expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, but are not limited to: (a) those risks and uncertainties identified as “risk factors” in our Prospectus filed with the Securities and Exchange Commission on April 26, 2021; and (b) the other risks detailed from time-to-time in our reports and registration statements filed with the Securities and Exchange Commission. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
12. Waiver. Failure to exercise or enforce any right or provision of this Agreement will not constitute a waiver of such right or provision or of any other right or provision contained herein. The section titles in this Agreement are for convenience only and have no legal or contractual effect. This Agreement has been drafted in English at the express request of the parties.
13. Copyright Infringement Claims. The information, documents, related graphics, and other content published on the Websites (the “Information”) are protected by United States and foreign copyright, trademark, and other intellectual property laws and are the sole property of Treace, except for information provided or licensed by third-parties to Treace, its subsidiaries or affiliates. You may use, e-mail, download, or print copies of the Information contained on the Websites for informational and non-commercial or personal use only, provided that (1) the above copyright notice appears on all copies; (2) the Information is not modified in any way; and (3) no graphics available from the Websites are used separate from accompanying text. Treace is not responsible for content provided by third-party providers, and you are prohibited from distribution of such material without permission of the owner of the copyright therein. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark or other proprietary right of Treace.
You may not use any Treace logos, trademarks, trade names, trade dress, products, or the names of any products or services appearing on the Websites without the prior written authorization of Treace, except to identify the products or services of Treace, including using any Treace Products in any advertisements or placing any advertisements that resemble or may be reasonably likely to confuse users as being a Treace advertisement. If you violate the foregoing restrictions on use, your permission to use the Websites shall be considered automatically revoked. All rights not expressly granted are reserved.
The Digital Millennium Copyright Act of 1998 (the “DMCA”) provides recourse for copyright owners who believe that material appearing on the Internet infringes their rights under U.S. copyright law. We suggest that you consult your legal advisor before filing a DMCA notice or counter-notice. You may have equivalent rights under other applicable laws.
If you believe in good faith that materials available on the Websites infringe your copyright, you (or your agent) may notify Treace by providing our Designated Agent with the following information in writing:
- Identification of the copyrighted work that you claim has been infringed;
- Identification of the material that is claimed to be infringing and information reasonably sufficient to permit Treace to locate the material;
- Your name, address, telephone number, and email address;
- A statement by you that you have a good faith belief that the disputed use is infringing and not authorized; and
- A statement, made under penalty of perjury, that the above information in your notice is accurate and that you are the copyright owner or are authorized to act on the copyright owner’s behalf.
- The electronic or physical signature of the copyright owner or a person authorized to act on the copyright owner’s behalf.
To submit a notification of claimed infringement, please contact Treace’s Designated Agent by mail to: Attention: Chief Legal Officer, Treace Medical Concepts, Inc., 230 Fort Wade Road, Suite 150, Ponte Vedra, Florida 32081, United States, or by e-mail to email@example.com. You can also reach Treace’s DMCA agent at the following phone number: (855) 673-3300.
If you believe in good faith that someone has wrongly submitted a notice of copyright infringement to us involving content that you made available through the Websites, the DMCA permits you to send to Treace a counter-notice. Notices and counter-notices must meet the then-current statutory requirements imposed by the DMCA. Click here for details. Counter-notices must also be sent in writing to Treace’s Designated Agent at the address or email address set forth above.