Outreach Portal License Agreement

INCORRECT: Lapiplasty’s design enables the correction of the bunion’s root cause.

Green indicates proper usage while red indicates improper usage of the trademark.
The two exceptions to this are:

– Company Name: Treace, Treace Medical Concepts, and the stylized Treace Medical Concepts, Inc. logos are TMC trademarks, but they can also function as the company’s name. If you use one of these marks solely for purposes of referring to TMC as a company, it can be treated as a noun.

– Logos: If you use a TMC Trademark that appears as a stylized graphic logo, you do not need to follow it with a noun unless you are using the logo in place of a word in a sentence.

Attribution/Ownership: TMC is the sole and exclusive owner of the Materials. The license granted in this Agreement and your use of the Materials give you no ownership rights in the Materials. Rather, it merely entitles you to use such Materials in accordance with this Agreement. Any improvements to or derivative works of the Materials that you make are and shall be owned by TMC, and you agree to enter into any further documents and take any further actions necessary to fully vest ownership of such improvements and derivative works in TMC. By using the Materials, you agree that:

– TMC is the exclusive owner of the Materials;

– Any goodwill arising from your use of any TMC trademarks is for TMC’s benefit;

– You will never challenge, contest, or interfere with TMC’s rights in its trademarks;

– You will never use the Materials in a manner that is deceptive, misleading, contrary to the Trademark Guidelines, or harmful to TMC’s brands and goodwill; and

– You will not make any improvements to or derivative works of the Materials without TMC’s prior consent.

Relatedly, any use of TMC Materials must be accompanied by an attribution statement recognizing that TMC is the owner of its trademarks. For instance, if your medical practice issues a press release announcing that you will soon begin offering the LAPIPLASTY® procedure, it should include the following language at the end: “LAPIPLASTY® is a registered trademark of Treace Medical Concepts, Inc.”

Consistent Stylization. Consistent Stylization. You will not alter the TMC Materials except as contemplated by the materials made available on the Website, such as adding your name and address in the Materials where shown. As examples, you may not:

– Shorten or abbreviate any TMC trademark;

– Create new marks based on or including the TMC trademark (e.g., with other words, symbols, numbers, or graphics);

– Convert any TMC trademark into an acronym or initialism TMC does not use;

– Modify the color, typeface, stylization, or proportions of any TMC trademark; or

– Modify the Materials to promote your practice, including describing the services your practice provides, describing your experience, expertise, and pedigree, or otherwise requesting that potential patients contact you to make an appointment. The Materials must remain educational in nature.

Notice Symbols. Whenever you use a TMC trademark, you must include an appropriate trademark notice symbol, which may be either:

– ™ for unregistered trademarks; or

– ® for registered trademarks.

The trademark notice symbols for each TMC Mark are shown in the TMC’s trademark usage guidelines on its website at www.treace.com/trademarkguidelines. When used, the notice symbols should be in superscript (e.g., ® or TM), but if superscript symbols are not available or cannot be used, the appropriate trademark notice symbols should be in parentheses: (R), (TM), (SM).

Quality Control. To ensure that TMC continues to have a reputation for superior-quality products and to comply with FDA guidance on marketing materials, TMC must ensure that appropriate quality control measures are implemented by all of its licensees. Accordingly, you agree to comply with the following:

– You may not tamper with or alter any products, product packaging, or promotional materials you receive from TMC and must maintain them in the condition they were in when you received them (ordinary wear and tear excepted in appropriate cases);

– You must use materials you receive from TMC in their entirety (no changes in context or content except as expressly contemplated);

– You will not modify the Materials in any manner except in the ways expressly described in this document without the prior written agreement of TMC, and any such modified Materials must be approved by TMC prior to their use;

– Any images of TMC products you use in print materials or online must depict the products fully and accurately, and may not be altered except as expressly permitted by TMC;

– You will make changes to your website and social media posts at the request of TMC to correct any false, misleading, off-label, out-of-date, or other problematic descriptions of TMC’s products; and

– Upon TMC’s request in a situation where TMC has information suggesting a misuse of its trademarks, medical devices, or materials, you will allow TMC to inspect your premises where any TMC products, packaging, or materials are maintained, and/or you will provide TMC with representative samples of such materials.

Your Marketing Materials. You agree that you will not take any of the following actions unless you have written approval from TMC:

– Adopting a trademark that is confusingly similar to any TMC trademarks;

– Using any stylized TMC Materials, including logos, in materials you create independently without TMC’s written permission;

– Featuring a TMC trademark as the primary brand in marketing pamphlets that do not follow the TMC Materials;

– Incorporating TMC Materials or potentially confusing variations of TMC Materials into your company name, domain name, product/service name, logo, slogan, etc.

– Using outdated TMC Materials or TMC Materials out-of-context on your website, including extracting portions of TMC Materials or discussing off-label use or inappropriate use of TMC’s products;

– Mimicking TMC’s advertising, product packaging, or website designs unless they are consistent with the Materials made available on the Website;

– Using language that suggests your marketing materials were created by TMC; or
– Incorporating Treace Marks into materials that contain off-label promotion or conducting any off-label promotion.

Updating of Materials: TMC reserves the right to withdraw, change, delete, and add Materials at any time at its sole discretion without notice. By using the Materials, you agree to periodically check TMC’s Website at least once a calendar quarter to obtain the most up-to-date Materials and to update the Materials that you use (e.g., on websites, social media, printed brochures, posters, etc.) to reflect the most up-to-date version. While TMC has no duty to inform you of changes to the Materials, by using the Materials you agree that if TMC notifies you to remove or change certain Materials that you have used (e.g., on websites, social media, printed brochures, posters, etc.), you agree to remove or update the Materials promptly as directed by TMC.

Compliance with Laws: You agree that your use and publication of the Materials will be in accordance with (A) all local, state, and federal laws including, without limitation, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et. seq.) and the federal anti-kickback statute set forth at 42 U.S.C. § 1320a-7b(B), (B) applicable provisions of the Advanced Medical Technology Association’s Code of Ethics for Interactions with Health Care Professionals (the “AdvaMed Code”) (available at https://www.advamed.org/member-center/resource-library/advamed-code-of-ethics/; and (C) all applicable policies of your employer or practice, including any conflict of interest policies and procedures.

No Off-Label or Other Inappropriate Use: You agree that you will not market or otherwise promote off-label uses of TMC products. Use and publication of the Materials is limited to education regarding FDA-cleared uses of TMC products. TMC products are not cleared for, and you should not promote the use of TMC products in skeletally immature patients. You agree that you will use the Materials in an appropriate context, will not alter or change the Materials, and will not use them to promote a competitor’s products or procedures or otherwise in a manner not approved by TMC.

The Materials are intended to provide a fair balance between information relating to risk and benefits of its products consistent with FDA guidance. To illustrate, statements in green below illustrate a fair balance approach while the statements in red are examples of inappropriate statements.

Patients can get back on their feet typically within 3-10 days in a walking boot.^1,2

 Patients can drive or walk within days after the Lapiplasty® Procedure.

The promotional information about the benefits of the Lapiplasty Procedure are accompanied by a listing of the risks and links to the Patient Risk Information, such as “Potential risks include infection, pain, implant loosening, and loss of correction due to improper bone healing. For more information about risks, see the Patient Risk Information.

 The promotion provides information about the benefits of the Lapiplasty® Procedures without a listing of the risks or link to the Patient Risk Information.

 A typical recovery timeline for the Lapiplasty® Procedure is as follows:
· Rapid Weight-Bearing (typically 3-10 days in a walking boot)^1,2
· Remain in a walking boot for 6-8 weeks after surgery, then transition to wearing comfortable shoes.¹
· Return to full, unrestricted activities (such as running) and normal footwear at 4-5 months after surgery.¹

 After the Lapiplasty® Procedure, patients are back in high heels within 3 weeks.

Lapiplasty® 3D Bunion Correction® corrects the entire bone in 3D and secures the root cause, an unstable joint in the midfoot.^1,3,4

The Lapiplasty® Procedure is the best way to correct a bunion. [Explanation: Direct comparative clinical studies of outcomes between types of bunion surgery are not available so direct comparative claims should be avoided.

1. Ray J, et al. Foot Ankle Int. 2019 Aug;40(8):955-9602
2. Dayton P, et al. J Foot Ankle Surg. 2019. 58:427-4333
3. Dayton P, et al. J Foot Ankle Surg. 2016. 55:567-71.
4. Dayton P, et al. J Foot Ankle Surg. 2018. 57:766-770.

You agree that you will not use or post the Materials on a website or in social media posts that contains false, misleading, off-label, out-of-date, or other inappropriate descriptions of TMC’s products. You agree, at the request of TMC, to remove any statements regarding TMC products on your website, from social media posts, or on any other electronic medium under your control that are false, misleading, off-label, out-of-date, or contain other problematic descriptions of TMC products. In addition, you agree, at the request of TMC, to add clarifying statements provided by TMC regarding TMC products on your website, on your social media posts, or on any other electronic medium under your control, to the extent necessary to correct a prior false, misleading, off-label, out-of-date, or other problematic statement regarding TMC products.

Stop Use upon Medical License Suspension or Debarment: You will immediately cease using the Materials if you are subject to any action impairing your license or reputation, including but not limited to if your license to practice in your profession in any state is restricted or suspended, you are suspended, excluded, or debarred from a federal health care program or from federal contracting by the U.S. General Services Administration, or you are indicted or convicted of a felony.

Term and Termination: This Agreement will remain in effect while you are using or publishing the Materials, subject to TMC’s right to terminate this Agreement and the license granted hereunder for any reason on 10 days prior written notice to you. All obligations that have accrued before termination or expiration of this Agreement will remain in effect.

Independent Contractor Relationship: You and TMC are independent contractors. Nothing in this Agreement will be construed to create any partnership, joint venture, principal-agent, or employer-employee relationship between you and TMC.

General Provisions: This Agreement constitutes the entire understanding between you and TMC relating to the subject matter hereof. There are no understandings or representations except as expressly set forth in this Agreement. No waiver or amendment is valid and binding unless in writing and signed by TMC. If any provision contained in this Agreement is invalid or unenforceable, all other provisions of this Agreement will be severable and will remain enforceable. This Agreement will be governed by the laws of the State of Florida, without regard to its conflict or choice of law rules.