OrthoPacks Practitioner Terms and Conditions
Effective Date: August 22, 2025
Welcome to the Ortho Molecular Products OrthoPacks Platform. These OrthoPacks Practitioner Terms and Conditions (“Terms”) are entered into by and between Ortho Molecular Products, Inc., a Wisconsin corporation (“Ortho,” “we,” “us,” or “our”), and the individual or entity to whom the applicable Ortho Molecular Products account is registered (“you,” or “your”).
1. Scope and Agreement to be Bound
These Terms govern your access to and use of the Ortho Molecular Products OrthoPacks e-commerce platform available at packs.orthomolecularproducts.com (the “Platform”). BY CLICKING TO ACCEPT THIS AGREEMENT, ACCESSING OR USING THE PLATFORM, OR BY PLACING ANY ORDER FOR PRODUCTS WITH ORTHO THROUGH ANY METHOD, YOU: (I) ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THESE TERMS IN THEIR ENTIRETY; AND (II) REPRESENT AND WARRANT THAT THE INDIVIDUAL ASSENTING ON YOUR BEHALF HAS THE FULL LEGAL AUTHORITY TO BIND YOU TO THESE TERMS. EACH SUCH ACTION CONSTITUTES YOUR ELECTRONIC SIGNATURE AND HAS THE SAME LEGAL FORCE AND EFFECT AS A HANDWRITTEN SIGNATURE. IF YOU DO NOT AGREE TO THESE TERMS, DO NOT USE THE PLATFORM OR PLACE ORDERS FOR PRODUCTS.
These Terms expressly incorporate by reference all policies, guidelines, and other terms and conditions (collectively, “Policies”) posted at or accessible via the Platform, as they may be updated from time to time, including but not limited to our Authorized Resale Policy and Privacy Policy. You acknowledge that these Policies are an integral part of these Terms and agree to be bound by them. You further acknowledge that it is your responsibility to review these Policies periodically to be aware of any updates. In the event of a conflict between these Terms and any other policy, agreement or document, the terms of these Terms shall prevail with respect to your use of the Platform.
Ortho reserves the right, at its sole discretion, to change, modify, add or remove portions of these Terms at any time by providing notice to you. Your continued use of the Platform following such notice will mean you accept and agree to the changes.
2. Definitions
“Authorized Resale Policy” means the then-current Ortho Molecular Products, Inc. Authorized Resale Policy for the United States, which is available at packs.orthomolecularproducts.com/authorized-resale-policy and which may be amended by Ortho from time to time.
“Confidential Information” includes, without limitation, all of Ortho’s non-public business information, trade secrets, product formulations, ingredient combinations, manufacturing methods (“Proprietary Formulations”), marketing strategies, pricing information, and the terms of these Terms.
“End User” means the individual patient associated with a Patient Account who (a) is the ultimate consumer of the Products purchased through such Patient Account; (b) has an established healthcare practitioner-patient relationship with you; and (c) does not intend to resell the Products. For the avoidance of doubt, an End User may be a minor, provided the associated Patient Account is created and managed by the minor’s parent or legal guardian.
“Intellectual Property Rights” means all industrial and other intellectual property rights comprising or relating to: (a) patents; (b) trademarks, service marks, trade names, logos, and other similar designations of source (“Trademarks”); (c) internet domain names, web addresses, and URLs; (d) works of authorship, expressions, and designs, whether or not copyrightable, including copyrights, software, code, data, databases, and other specifications and documentation; (e) trade secrets; and (f) all other equivalent legal rights and protections, whether registered or unregistered, and including all registrations, applications, renewals, or extensions thereof.
“Law” means any federal, state, local or foreign law, statute, code, ordinance, regulation, rule, constitution, treaty, common law, or any rule, order, policy, or regulation of any governmental authority.
“Patient Account” means a unique account on the Platform created by an End User or their legal guardian at your invitation for the purpose of purchasing Products you recommend.
“Products” means those items manufactured by or for Ortho and made available for sale through the Platform.
“Representatives” means a party’s affiliates, parent companies, subsidiaries, employees, officers, directors, agents, attorneys, and permitted assigns.
3. Your Relationship with Ortho
Ortho hereby appoints you, and you accept the appointment, to act as a non-exclusive reseller of Products to Patient Accounts associated with you, solely through the functionality of the Platform and in accordance with the terms of these Terms.
The relationship between Ortho and you is solely that of vendor and vendee. Nothing in these Terms creates any agency, joint venture, partnership, employment, or fiduciary relationship. You are an independent contractor and have no authority to assume or create any obligations on behalf of Ortho. The parties acknowledge that these Terms are not a franchise or business opportunity agreement. If any provision is deemed to create such a relationship, Ortho shall have the sole discretion to immediately terminate these Terms.
4. Your Account and Responsibilities
Qualifications. To be eligible for, create, and maintain an account on the Platform, you must satisfy one of the following two qualifications at all times during the Term. You represent, warrant, and covenant that: (i) you are an individual healthcare practitioner who is duly licensed, in good standing, and otherwise qualified under all applicable Laws and professional standards to recommend and sell the Products; or (ii) you are a business entity that designates a healthcare practitioner who satisfies the requirements of subsection (a) (the “Designated Practitioner”) to act as your authorized agent. You further represent that any Designated Practitioner is vested with, and you shall ensure they continuously maintain, the full authority to act on your behalf in all matters concerning clinical judgment and professional responsibility required under these Terms.
Clinical Responsibility. You acknowledge and agree that you are solely and exclusively responsible for all professional judgments, advice, and clinical services rendered in connection with the Platform and the Products. In providing such services, you shall ensure that all your activities adhere to the prevailing professional standards of care and comply fully with all applicable Laws and regulations, including, without limitation, those relating to export controls, trade sanctions, and economic embargoes, as well as all Ortho policies incorporated by reference into these Terms. Any reference herein to an obligation or liability of “You” related to the exercise of professional or clinical judgment shall also be understood to be fulfilled by your Designated Practitioner, as applicable. You shall remain fully and vicariously liable for all acts and omissions of your Designated Practitioner acting in such capacity.
Verification and Notification. Upon Ortho’s request, you shall promptly furnish documentation sufficient to verify the existence and bona fide nature of the qualifications and authorization required under this section. You shall provide Ortho with immediate written notification of any event that causes you to be in breach of your covenants under this section, including, without limitation, any lapse in licensure, qualifying status, or failure to engage a Designated Practitioner. The failure to maintain compliance with this section, including the failure to provide immediate notice or satisfactory verification upon request, shall constitute a material breach of these Terms.
Account Security. You are responsible for maintaining the confidentiality of your account information and password and for all activity that occurs under your account. You shall not use the account or password of any other individual. Ortho shall be entitled accept the instructions of any individual who claims to be authorized to direct changes to your account so long as such person presents your username and password online, by email or by phone, or through a third-party service, if any, through which you access the Platform. You agree to notify Ortho immediately of any unauthorized use of your account. Ortho is not liable for any loss or damage arising from your failure to comply with these obligations.
Audit Rights. Upon reasonable prior notice and during regular business hours, Ortho or its designated Representatives may audit your compliance with these Terms and the Authorized Resale Policy. You agree to cooperate fully with any such audit and to retain and make available relevant records for a period of at least two (2) years from the date of any transaction.
Marketing and Use of the Platform. You shall, in good faith and at your own expense, comply with the Authorized Resale Policy and observe all directions and instructions given by Ortho in relation to the marketing and promotion of the Products. In furtherance of and in addition to these obligations, you agree to adhere to the specific prohibitions set forth below.
A. General Conduct and Sales Practices. Neither you nor your Representatives shall (i) engage in any illegal, fraudulent, malicious, negligent unfair, competitive, misleading, or deceptive practices, including product disparagement or “bait-and-switch” practices; (ii) sell, divert, or transfer Products to any person or entity when you know or have reason to suspect that the person or entity may resell the Products; (iii) sell Products through except through the Platform (iv) submit any claims for reimbursement for Products to any third-party payor, including any federal, state, or commercial insurance program or provider, or count the amount paid toward an insurance deductible or out-of-pocket spending requirement; (v) engage in any conduct that interferes with other users’ use of the Platform, including, without limitation, spamming, harassment or otherwise using abusive tactics; or (vi) engage in any conduct that may bring Ortho into disrepute or endanger the business, goodwill, or safety of Ortho or any third party.
B. Product and Claims Integrity. Neither you nor your Representatives shall (i) complete any sale of Products in quantities or unit volumes inappropriate for an End User’s individual use; (ii) make any representations, warranties, guarantees, indemnities, or similar claims regarding the Products that are not explicitly stated on the Product’s label or in official Ortho documentation, or that are inconsistent therewith; (iii) make any claims regarding the use of Products that do not appear on the applicable Product’s label, including any claims that Products treat specific diseases or conditions; or (iv) change, remove, add to, cover, replace, or otherwise alter or obscure all or part of any Product’s label, packaging, lot number, or other identifying information.
C. Digital Marketing and Branding. Neither you nor your Representatives shall (i) use the Platform or any other Ortho digital property for any unlawful, fraudulent, or malicious purpose, to violate the rights of any third party, or to compromise its integrity, including by introducing viruses, worms, Trojan horses, or any other contaminating or destructive code, or through malware, hacking, cracking, phishing, or SQL injecting; (ii) use any spider, bot, or other automatic or manual device or process for the purpose of scraping, harvesting, compiling, indexing, surveying, building AI/machine learning models or data mining information from the Platform or other Ortho websites or digital properties including probing, scanning, or testing the vulnerability of the Platform; (iii) use any Ortho Trademark or copyrighted material in any content, medium, or communication to state or imply any partnership, endorsement, or affiliation beyond your status as an authorized reseller of genuine Products, or to otherwise create a website or online presence that appears to be an official site of Ortho or could create a false or misleading association with Ortho; (iv) use any Ortho Trademark in any pay-per-click advertising, search engine marketing, or any other form of online or offline advertising, or bid on or purchase any keyword that is an Ortho Trademark or any confusingly similar term, or use any Ortho Trademark in any online ad text, metatag, or search engine-optimized text; (v) use any Ortho Trademark in any part of a domain name, subdomain, social media account name, or other online identifier; (vi) use any framing, mirroring, or similar techniques to enclose or redisplay any part of the Platform or Ortho’s other websites; (vii) (vii) decompile, reverse engineer, create derivative works from, or otherwise exploit any content, information, or Confidential Information from the Platform or any other Ortho digital property without our express written permission; or (viii) fail to use commercially reasonable efforts to both prevent any online content associated with or to you from appearing in response to user searches for Ortho Trademarks and promptly remove or retract any content inconsistent with the prohibitions set forth in this Section.
Use for Minor Patients. The Platform is not intended for direct use by individuals under the age of 18. If you use the Platform to manage care or sell Products for the benefit of a minor patient, you represent and warrant that you have obtained all legally required and valid consents from the minor’s parent or legal guardian to do so. You are solely responsible for compliance with all Laws pertaining to the privacy and treatment of minors. You agree to indemnify and hold Ortho harmless from any and all Losses arising from your failure to obtain such consent.
You further acknowledge that certain jurisdictions may now or in the future impose restrictions on the sale of certain categories of products to minors or other protected classes of persons. You agree that you are solely responsible for: (i) identifying any Products subject to such restrictions in any jurisdiction where you or your End Users are located; and (i) implementing and maintaining commercially reasonable age-verification procedures sufficient to ensure compliance with all such applicable Laws.
Communications. By creating an account, you consent to receive electronic communications from us (e.g., via email, SMS, or push notifications). These communications may include notices about your account (e.g., password changes, order confirmations, and refill reminders) and are part of your relationship with us. We may also send you promotional communications. You may opt out of promotional communications by following the unsubscribe instructions in those messages or by changing your account settings, but you may not opt out of transactional communications essential to your account.
5. Commercial Terms
Models. The Platform offers the following two commercial models for processing transactions with Patient Accounts. You will be enrolled in one of the following models based on your selection and Ortho’s approval.
Ortho as Payment Collection Agent. Product listings on the Platform are invitations for Patient Accounts to submit orders to purchase Products from you, as seller of record, at the retail prices displayed therein. Ortho reserves the right to reject or cancel any order prior to confirming it.
For each Patient Account order confirmed by Ortho, you agree to purchase the Product from Ortho at Ortho’s then-current practitioner price. You authorize Ortho, acting as your payment collection agent, to collect the full retail amount for such order, and you agree to pay Ortho a platform service fee in consideration for providing the Platform and its related services. To facilitate the foregoing, you irrevocably authorize Ortho to deduct the amounts owed to Ortho for the Product and services from the funds collected on your behalf and to remit the remaining balance to you on a regular payment schedule. You represent and warrant that your use of the Platform and all transactions hereunder will comply with all applicable laws, including state laws governing healthcare professionals.
You must notify Ortho in writing of any payment dispute within seven (7) business days of receiving the relevant payment report, after which time such remittance will be deemed final and accepted by you.
If your total sales of Products, calculated at the practitioner price, are less than one thousand five hundred ($1,500.00) U.S. dollars in any calendar month, you agree to pay Ortho a monthly service fee of twenty five ($25.00) U.S. dollars. This minimum sales requirement and associated service fee shall not take effect until the third full calendar month following your enrollment on the Platform, with the first month being calculated as the first full calendar month after enrollment.
Practitioner Merchant Account. If you enroll your own merchant account with a payment processor designated by Ortho (the “Payment Processor”), you acknowledge and agree that: (i) you are responsible for completing all necessary underwriting activities with the Payment Processor; (ii) the Payment Processor will process all Patient Account payments and deposit funds directly into your merchant account; (iii) upon shipment of the Product by Ortho to a Patient Account, Ortho shall charge your credit card or other payment method on file with Ortho for the applicable practitioner price; and (iv) your use of the Payment Processor must be exclusively for transactions related to Products on the Platform.
If your total sales of Products, calculated at the practitioner price, are less than seven hundred fifty ($750.00) U.S. dollars in any calendar month, you agree to pay Ortho a monthly service fee of twenty five ($25.00) U.S. dollars. This minimum sales requirement and associated service fee shall not take effect until the third full calendar month following your enrollment on the Platform. This minimum sales requirement and associated service fee shall not take effect until the third full calendar month following your enrollment on the Platform, with the first month being calculated as the first full calendar month after enrollment.
Shipping, Title, and Risk of Loss. Ortho ships Products directly to the Patient Account on your behalf. As between Ortho and you, title and risk of loss for the Products pass to you when Ortho delivers the Products to the shipping carrier for shipment to the address associated with the Patient Account. All shipping times are estimates and not guarantees.
Taxes. You acknowledge and agree that where Ortho is required by Law to act as a marketplace facilitator, Ortho will calculate, collect, and remit the applicable sales and use taxes directly to the appropriate governmental authorities on the relevant confirmed transactions (“Marketplace Tax Collection”). You authorize Ortho to take all actions necessary to comply with its obligations regarding Marketplace Tax Collection and agree to promptly provide any information reasonably requested by Ortho to facilitate such compliance. Ortho’s performance of Marketplace Tax Collection in certain jurisdictions does not relieve you of your primary responsibility for taxes in all other jurisdictions or for any other taxes related to your business, including, without limitation, franchise, gross receipts, or income taxes. You are solely responsible for determining your own tax obligations and for the collection, reporting, and remittance of all applicable taxes, including sales, use, and other similar taxes, arising from your sales of Products through the Platform.
Without limiting your other obligations, you agree to indemnify, defend, and hold harmless Ortho and its Representatives from and against any and all Losses arising from or relating to taxes, penalties, or interest asserted against Ortho by any governmental authority as a result of any inaccurate or incomplete information provided by you or your failure to fulfill your tax obligations in any jurisdiction where Ortho is not performing Marketplace Tax Collection.
Returns, Chargebacks, and Setoff. As seller of record, you are solely and exclusively responsible for all financial liability arising from chargebacks, payment disputes, refunds, and other post-sale adjustments initiated by your associated Patient Accounts. You irrevocably authorize Ortho to deduct and set off from any payments due to you the full amount of any such chargeback, refund, and all associated fees, fines, or penalties, as well as any other debt, liability, or amount owed by you to Ortho or its affiliates, whether under this Agreement or any other agreement, and whether now existing or hereafter arising.
Nature of Financial Accounts. You acknowledge and agree that Ortho is not a bank or other licensed financial institution. Any funds held by Ortho or its payment processors on your behalf prior to remittance are not deposits and are not insured by the Federal Deposit Insurance Corporation (FDIC) or any other governmental agency. Ortho may commingle your funds with the funds of other users. Ortho will track and attribute the amounts owed to you based on its internal records of the transactions processed on your behalf and you agree that these records shall be the definitive source for calculating remittances.
6. Intellectual Property
Ownership. You acknowledge that all Intellectual Property Rights in and to the Platform and the Products, including but not limited to, underlying software and technology, text, applications, sound, photographs, images, logos, video, and graphics (collectively, the “Content”), are the sole and exclusive property of Ortho or its licensors. You shall not acquire any ownership interest in any of Ortho’s Intellectual Property Rights under these Terms. Any goodwill derived from your use of Ortho’s Intellectual Property Rights inures to the benefit of Ortho or its licensors, as the case may be. If you acquire any Intellectual Property Rights in or relating to any Product purchased under these Terms (including any rights in any Trademarks, derivative works, or patent improvements relating thereto), by operation of law or otherwise, these rights are deemed and are hereby irrevocably assigned to Ortho or its licensors, as the case may be, without further action by either party.
Trademark License. Ortho grants you a non-exclusive, non-transferable, non-sublicensable, revocable license to use Ortho’s Trademarks during the Term solely in connection with the promotion and resale of the Products on the Platform under, and in accordance with, the terms of these Terms and the Authorized Resale Policy. When requested by Ortho, you shall promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used. You shall ensure that all materials carrying Ortho’s Trademarks are marked with the appropriate trademark notices in accordance with Ortho’s instructions. This license terminates immediately upon termination of these Terms.
Platform License. Ortho grants to you a limited, personal, revocable, non-exclusive, non-transferable right to access and use the Platform and its Content solely for the purposes set forth in these Terms, subject at all times to its terms and so long as your account is in good standing.
Scope and Limitation. The licenses granted to you in this section are strictly limited to the subject matter of these Terms and are granted solely for the purpose of exercising your rights and performing your obligations as contemplated herein. These licenses are separate and distinct from, and shall not be construed to expand, limit, or otherwise affect, any rights or licenses granted under any other agreement between you and Ortho, unless such other agreement expressly references and modifies these Terms in writing.
Your Use of Our Intellectual Property. You shall not challenge any right, title, or interest of Ortho in, or take any action adverse to, Ortho’s ownership of its Intellectual Property Rights; apply for, register, or use any confusingly similar marks; misappropriate any of Ortho’s Trademarks for use as a domain name without prior written consent from Ortho; alter, obscure or remove any of Ortho’s trademarks or trademark or copyright notices or any other proprietary rights notices placed on Products or any marketing materials or other materials that Ortho may provide to you; or engage in any action that tends to disparage, dilute, or reflect negatively on the value of Ortho’s Trademarks.
License to Your Content. You may provide, post, upload, or otherwise submit content or materials to the Platform, including but not limited to your logos, trademarks, photographs, videos, and text (“Your Content”). You hereby grant to Ortho and its affiliates a worldwide, perpetual, irrevocable, non-exclusive, fully paid-up, royalty-free, and sublicensable license to use, host, reproduce, prepare derivative works from, display, perform, publish, and distribute Your Content in connection with operating, providing, and promoting the Platform and Ortho’s business. You represent and warrant that you own all rights in and to Your Content, or have obtained all necessary rights and permissions, to grant this license, and that Your Content does not and will not infringe upon the Intellectual Property Rights or other rights of any third party.
Reporting Intellectual Property Infringement. Ortho respects the intellectual property rights of others and requires its users to do the same. If you believe that your work has been copied in a way that constitutes copyright infringement or that your trademark rights have been otherwise violated, please provide Ortho’s designated Copyright Agent with the following information in writing: (a) a physical or electronic signature of a person authorized to act on behalf of the owner of the right that is allegedly infringed; (b) identification of the copyrighted work or trademark claimed to have been infringed; (c) identification of the material that is claimed to be infringing and information reasonably sufficient to permit Ortho to locate the material; (d) your address, telephone number, and email address; (e) a statement by you that you have a good faith belief that the disputed use is not authorized by the owner, its agent, or the law; and (f) a statement by you, made under penalty of perjury, that the above information in your notice is accurate and that you are the owner of the right or are authorized to act on the owner’s behalf. Ortho’s designated copyright agent for notice of claims of infringement can be reached at [email protected].
7. Confidentiality
You acknowledge that in the course of performing your obligations under these Terms, you will be exposed to Ortho’s Confidential Information (as defined below). You agree to hold all Confidential Information in strict confidence and shall not use or disclose such information for any purpose other than the performance of your obligations under these Terms. You shall protect Ortho’s Confidential Information with at least the same degree of care as you protect your own confidential information, but in no event with less than a commercially reasonable degree of care. This obligation of confidentiality shall survive the termination of these Terms.
You agree that you shall not, and shall ensure your Representatives do not, directly or indirectly, reverse engineer, deconstruct, decompile, or perform any chemical or other analysis of any Product for the purpose of identifying, duplicating, or otherwise misappropriating its Proprietary Formulations.
8. HIPAA and Protected Health Information
If you are a “Covered Entity” as defined under HIPAA, you agree that your relationship with Ortho makes Ortho your “Business Associate.” In such a case, you agree to be bound by the terms of the Business Associate Agreement (“BAA”) attached hereto as Exhibit A, which is hereby incorporated by reference. Notwithstanding anything to the contrary in these Terms, the terms of the BAA shall govern the use, disclosure, and protection of Protected Health Information.
9. Disclaimers, Liability, and Indemnification
Medical Disclaimer. You acknowledge and agree that all information, data, and content provided on the Platform is for informational purposes only and is intended to supplement, not replace, your professional medical judgment, skill, and expertise. Ortho does not provide medical advice or practice medicine. You are exclusively and solely responsible for all professional advice, treatment decisions, and healthcare services provided to your End Users, including the determination of whether a Product is appropriate for a particular End User. This responsibility includes, without limitation, the independent clinical assessment of any potential interactions or contraindications arising from the use of multiple dietary supplements, whether or not such products are sold through the Platform. You acknowledge that health statements made about Products have not been evaluated by the U.S. Food and Drug Administration.
WARRANTY DISCLAIMER. THE PLATFORM AND PRODUCTS ARE PROVIDED “AS IS” AND “AS AVAILABLE”. TO THE MAXIMUM EXTENT PERMITTED BY LAW, ORTHO DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING ANY WARRANTIES OF ACCURACY, COMPLETENESS, TIMELINESS MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. ORTHO DOES NOT WARRANT THAT THE OPERATION OF THE PLATFORM OR THE PROVISION OF SERVICES WILL BE UNINTERRUPTED OR ERROR-FREE. ORTHO EXPRESSLY DISCLAIMS ALL LIABILITY FOR PRODUCT DEFECT OR FAILURE, CLAIMS DUE TO NORMAL WEAR, PRODUCT MISUSE, ABUSE, PRODUCT MODIFICATION, IMPROPER PRODUCT SELECTION, NON-COMPLIANCE WITH ANY CODES, OR MISAPPROPRIATION.
LIMITATION OF LIABILITY. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL ORTHO OR ITS REPRESENTATIVES BE LIABLE UNDER THIS AGREEMENT FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, OR FOR ANY LOST PROFITS OR REVENUES, LOSS OF DATA, OR DIMINUTION IN VALUE OR LOSS OF GOODWILL, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE, WHETHER OR NOT ORTHO WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND REGARDLESS OF THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE) UPON WHICH THE CLAIM IS BASED.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL THE TOTAL AGGREGATE LIABILITY OF ORTHO AND ITS REPRESENTATIVES ARISING OUT OF OR RELATED TO THIS AGREEMENT EXCEED THE TOTAL NET PROCEEDS ACTUALLY PAID BY ORTHO TO YOU UNDER THIS AGREEMENT DURING THE SIX (6) MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO THE CLAIM. THE LIMITATIONS SET FORTH HEREIN SHALL APPLY EVEN IF YOUR REMEDIES UNDER THIS AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE.
FOR THE AVOIDANCE OF DOUBT, THE LIMITATIONS SET FORTH HEREIN APPLY TO ALL CLAIMS AGAINST ORTHO, AND ORTHO SHALL HAVE NO LIABILITY WHATSOEVER FOR ANY LOSSES, DAMAGES, OR CLAIMS OF ANY KIND ARISING FROM OR RELATED TO THE PROFESSIONAL SERVICES, ADVICE, OR JUDGMENT PROVIDED BY YOU TO ANY CLIENT ACCOUNT OR END USER. YOU ACKNOWLEDGE AND AGREE THAT THE FOREGOING LIMITATIONS ARE AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN THE PARTIES.
IN FURTHERANCE THEREOF, YOU HEREBY EXPRESSLY WAIVE AND RELEASE ANY AND ALL CLAIMS AND DEMANDS AGAINST ORTHO AND ITS REPRESENTATIVES THAT YOU DO NOT KNOW OR SUSPECT TO EXIST IN YOUR FAVOR AT THE TIME OF AGREEING TO THESE TERMS. THIS WAIVER IS INTENDED TO BE A FULL AND FINAL GENERAL RELEASE. ACCORDINGLY, YOU EXPRESSLY ACKNOWLEDGE THAT YOU HAVE BEEN ADVISED OF, AND HEREBY KNOWINGLY WAIVE, THE PROTECTIONS OF CALIFORNIA CIVIL CODE SECTION 1542 (“A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.”) AND ANY OTHER FEDERAL, STATE, OR FOREIGN LAW, REGULATION, OR PRINCIPLE OF COMMON LAW OF SIMILAR EFFECT.
Indemnification. You shall indemnify, defend, and hold harmless Ortho and its parent, officers, directors, partners, members, shareholders, employees, agents, contractors, affiliates, successors and permitted assigns (collectively, “Indemnified Parties”) from and against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including reasonable attorneys’ fees, fees and the costs of enforcing any right to indemnification under these Terms and the cost of pursuing any insurance providers (collectively, “Losses”), arising out of or relating to any claim of a third party relating to: (a) a breach or non-fulfillment of any representation, warranty, covenant, or other provision of these Terms by you or your Representatives; (b) any grossly negligent or more culpable act or omission of you or your Representatives (including any recklessness or willful misconduct) in connection with the performance of your obligations under these Terms; (c) any bodily injury, death of any person, or damage to real or tangible personal property caused by the negligent or more culpable acts or omissions of you or your Representatives; (d) any act, error, or omission arising from the exercise of your professional judgment or the provision of clinical services to any End User, including, without limitation, any statements, claims, advice, or protocols, regardless of whether such conduct relates to the Products; (e) any violation of any applicable Law by you or your Representatives; or (f) a purchase of a Product directly or indirectly through you via the Platform.
10. Term and Termination
Suspension. Ortho reserves the right, in its sole discretion, to temporarily suspend your account, restrict purchasing privileges, or place payments on hold pending an investigation into any activity that Ortho reasonably suspects may constitute a breach of these Terms or may be fraudulent, illegal, or harmful to Ortho, its platform, or any third party. Ortho shall have no liability for any losses, damages, or claims of any kind resulting from a suspension implemented in accordance with this section.
Termination. Ortho may, in its sole and absolute discretion, terminate your account and these Terms at any time, for any reason or for no reason, with or without prior notice. This right of termination is absolute and shall not be subject to any cure period or other requirement, nor shall it be limited by any other provision of these Terms. Without limiting the generality of the foregoing absolute right to terminate, Ortho may also terminate these Terms immediately upon written notice to you if: (i) you breach any provision of these Terms and such breach is not cured by you within ten (10) days after your receipt of written notice thereof; or (ii) you become subject to any proceeding related to insolvency or bankruptcy, file for bankruptcy, make an assignment for the benefit of creditors, or undergo a change of control without Ortho’s prior written consent. You may terminate these Terms, without cause, by providing sixty (60) days’ prior written notice to Ortho.
Effect of Termination. Upon termination of these Terms for any reason, (i) all rights and licenses granted to you hereunder shall immediately cease, and you shall immediately cease to represent yourself as an authorized reseller of Products; (ii) Ortho’s sole liability to you shall be limited to the remittance of any undisputed net proceeds due to you for sales confirmed prior to the effective date of termination; provided, however, that if termination is due to your breach of these Terms, Ortho shall have no obligation to remit any funds and may, in its sole discretion, offset any payments due against its actual or potential damages arising from the breach; (iii) you agree that you will not thereafter access or attempt to use the Platform or establish a new professional account under any name, real or assumed and agree to indemnify, defend, and hold harmless Ortho and its Representatives from any and all Losses arising from your breach of this provision; and (iv) all provisions of these Terms which by their nature should survive termination shall so survive, including, without limitation, provisions regarding Intellectual Property, Confidentiality, Disclaimers, Liability, Indemnification, and financial obligations incurred prior to termination. Following termination, you agree that you will not attempt to use the Platform under any other name or entity real or assumed. If you violate this restriction, you agree to indemnify, defend, and hold harmless Ortho and its Indemnified Parties from any and all liability, losses, or expenses incurred as a result of such unauthorized use.
11. General Provisions
Entire Agreement. These Terms, including and together with the Privacy Policy, Authorized Resale Policy, and any related exhibits, schedules, and appendices, constitutes the sole and entire agreement of the parties with respect to the subject matter of these Terms and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, with respect to such subject matter, including, without limitation, any prior reseller agreements.
Notices. All notices, requests, consents, claims, demands, waivers, and other communications hereunder (each, a “Notice”) must be in writing. Ortho may provide Notice to you by email to the email address associated with your account or by posting notices on the Platform. You are responsible for keeping your email address current. Notice to Ortho must be delivered by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid) to Ortho Molecular Products, Inc., Attn: Legal Department, 540 W. Northwest Hwy., Ste 200, Barrington, IL 60010.
Amendment and Modification. Ortho reserves the right, in its sole and absolute discretion, to amend these Terms at any time. Ortho will make the revised Terms available by posting them on the Platform and will update the “Effective Date” for these Terms. You acknowledge and agree that it is your sole responsibility to review these Terms periodically to familiarize yourself with any modifications. Your continued use of the Platform after such amendments are posted shall constitute your acknowledgment and binding acceptance of the amended Terms. As a condition of continued access or use of the Platform, particularly following material amendments, Ortho may also require that you affirmatively accept the revised Terms by clicking “I Accept” or a similar mechanism of express consent.
Waiver. No waiver by Ortho of any provision of these Terms is effective unless explicitly set forth in a writing signed by an authorized representative of Ortho. No failure to exercise, or delay in exercising, any right, remedy, or power arising from these Terms shall operate as a waiver thereof, nor shall any single or partial exercise of any right, remedy, or power hereunder preclude any other or further exercise thereof.
Severability. If any term or provision of these Terms is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability shall not affect any other term or provision of these Terms or invalidate or render unenforceable the term or provision in any other jurisdiction. Upon such determination, the parties shall negotiate in good faith to modify these Terms so as to effect the original intent of the parties as closely as possible.
Governing Law and Venue. These Terms are governed by and construed in accordance with the internal laws of the State of Wisconsin without giving effect to any choice or conflict of law provision or rule. Any legal suit, action, or proceeding arising out of these Terms shall be instituted exclusively in the federal or state courts located in the State of Wisconsin, and each party irrevocably submits to the exclusive jurisdiction of such courts.
Assignment. You may not assign any of your rights or delegate any of your obligations under these Terms without the prior written consent of Ortho. Any purported assignment or delegation in violation of this Section is null and void. Ortho may assign its rights and obligations under these Terms at its sole discretion.
Successors and Assigns. These Terms are binding on and inure to the benefit of the parties and their respective permitted successors and assigns.
No Third-Party Beneficiaries. These Terms benefit solely the parties to these Terms and their respective permitted successors and assigns, and nothing in these Terms, express or implied, confers on any other person any legal or equitable right, benefit, or remedy of any nature whatsoever under or by reason of these Terms.
Cumulative Remedies. All rights and remedies provided in these Terms are cumulative and not exclusive, and the exercise by either party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or later be available at law, in equity, by statute, in any other agreement between the parties, or otherwise.
Force Majeure. You agree that Ortho shall not be liable or responsible to you for any failure or delay in the performance of its obligations under these Terms if such failure or delay is the result of events beyond its reasonable control. Such events include, but are not limited to: (a) acts of God; (b) war, insurrection, riots, terrorism, or crime; (c) embargoes or blockades; (d) government order, law, or action, including pandemics or epidemics; (e) labor shortages, strikes, or other industrial disturbances; (f) postal disruption, failure of telecommunications or internet infrastructure, or unavailability of payment processors; (g) failure or shortage of necessary infrastructure or materials; or (h) any other event beyond Ortho’s reasonable control. In the event of any such failure or delay that interferes with Ortho’s ability to deliver confirmed orders, Ortho will use commercially reasonable efforts to fulfill and deliver such orders as soon as practicable.
Further Assurances. Upon Ortho’s reasonable request, you shall, at your sole cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, reasonably necessary to give full effect to these Terms.
12. Third-Party Resources
The Platform may contain links to third-party websites, applications, or other resources. These links are provided solely as a convenience to you and not as an endorsement by Ortho of the content or services on such third-party resources. Ortho is not responsible for the content, accuracy, or availability of any third-party resources. You acknowledge and agree that Ortho shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any such content, goods, or services available on or through any such third-party resource. Your use of third-party resources is at your own risk and subject to the terms and conditions of use for such resources.
EXHIBIT A
BUSINESS ASSOCIATE AGREEMENT
This Business Associate Agreement (this “BAA” or “Agreement”) is entered into by and between Ortho Molecular Products, Inc., a Wisconsin corporation (“Business Associate”), and the individual or entity to whom the applicable Ortho Molecular Products account is registered (“Covered Entity”), and is effective as of the date of Covered Entity’s acceptance of the Terms (as defined below).
RECITALS
WHEREAS, pursuant to the parties’ separate OrthoPacks Practitioner Terms and Conditions (the “Terms”), Business Associate has agreed to perform certain services for or on behalf of Covered Entity (the “Services”) that may involve the creation, receipt, maintenance, use, transmission, or disclosure of Protected Health Information.
WHEREAS, the parties are entering into this BAA to comply with the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations at 45 C.F.R. Parts 160 and 164, as may be amended from time to time (collectively, the “HIPAA Rules”).
WHEREAS, if and only to the extent that Covered Entity is a “covered entity” and Business Associate is a “business associate,” each as defined in the HIPAA Rules, this BAA supplements the Terms and is intended to satisfy the requirements for business associate agreements as set forth in the HIPAA Rules. If Business Associate is not a business associate as defined in the HIPAA Rules with respect to its relationship with Covered Entity, this BAA shall be void and of no force or effect.
NOW, THEREFORE, in consideration of the mutual promises set forth herein and in the Terms, the parties agree as follows:
1. Definitions
Capitalized terms used but not otherwise defined in this BAA shall have the same meaning as those terms in the HIPAA Rules.
a. Breach shall have the same meaning as the term “breach” at 45 C.F.R. § 164.402.
b. Business Associate shall have the meaning at 45 C.F.R. § 160.103, and in reference to the party to this BAA, shall mean Ortho Molecular Products, Inc.
c. Covered Entity shall have the meaning at 45 C.F.R. § 160.103, and in reference to the party to this BAA, shall mean the counterparty to this BAA.
d. Discovery shall have the same meaning as the term “discovery” at 45 C.F.R. § 164.410(a)(2).
e. Protected Health Information or “PHI” shall have the meaning at 45 C.F.R. § 160.103, and shall be limited to any PHI that is created, received, maintained, or transmitted by Business Associate on behalf of Covered Entity pursuant to the Terms.
f. Secretary shall mean the Secretary of the U.S. Department of Health and Human Services or their designee.
2. Business Associate Responsibilities. Business Associate agrees to:
2.1. Comply with the applicable provisions of the HIPAA Rules relating to the privacy or security of PHI, including, without limitation, 45 C.F.R. Part 171 (the “Information Blocking Rule”), and relevant state laws, to the extent such laws and regulations apply to Business Associate in its capacity as such.
2.2. Not use or disclose PHI except as permitted or required by this BAA or as Required By Law.
2.3. Use appropriate safeguards and comply, where applicable, with the HIPAA Security Rule with respect to Electronic PHI, to prevent the use or disclosure of PHI other than as permitted by this BAA.
2.4. Report to Covered Entity any use or disclosure of PHI not permitted by this BAA of which it becomes aware, including Breaches of Unsecured PHI. Such report shall be made without unreasonable delay and in no case later than thirty (30) calendar days after the Discovery of a Breach. Business Associate shall also report any Security Incident of which it becomes aware; provided, however, that the parties acknowledge and agree that this section shall serve as notice that Business Associate periodically experiences unsuccessful Security Incidents (such as pings, port scans, or unsuccessful login attempts) that do not result in unauthorized access, use, or disclosure of PHI, and that no further notice to Covered Entity shall be required for such unsuccessful attempts.
2.5. Ensure that any Subcontractor that creates, receives, maintains, or transmits PHI on behalf of Business Associate agrees, in writing, to no less than the same restrictions, conditions, and requirements that apply to Business Associate with respect to such PHI, in accordance with 45 C.F.R. §§ 164.308(b)(2) and 164.502(e)(1)(ii).
2.6. Upon Covered Entity’s prior written request, and within fifteen (15) business days of receipt of such request, make available to Covered Entity any PHI in a Designated Record Set as necessary to enable Covered Entity to satisfy its obligations to provide an Individual with access to PHI under 45 C.F.R. § 164.524, and take such other action as necessary to enable Covered Entity to comply with the Information Blocking Rule. Business Associate shall not knowingly take any action that would cause Covered Entity to be in violation of the Information Blocking Rule.
2.7. Upon Covered Entity’s prior written request, and within thirty (30) days of receipt of such request, make available PHI in a Designated Record Set for amendment and incorporate any amendments to PHI as necessary to enable Covered Entity to satisfy its obligations under 45 C.F.R. § 164.526.
2.8. Upon Covered Entity’s prior written request, and within thirty (30) days of receipt of such request, make available the information required to provide an accounting of disclosures as necessary to enable Covered Entity to satisfy its obligations under 45 C.F.R. § 164.528.
2.9. To the extent Business Associate is to carry out one or more of Covered Entity’s obligation(s) under Subpart E of 45 C.F.R. Part 164, comply with the requirements of Subpart E that apply to the Covered Entity in the performance of such obligation(s).
2.10. Make Business Associate’s internal practices, books, and records relating to the use and disclosure of PHI available to the Secretary for purposes of determining Covered Entity’s compliance with the HIPAA Rules.
3. Permitted Uses and Disclosures by Business Associate.
3.1. Permissible Uses and Disclosures. Business Associate may use or disclose PHI only as follows:
a. As necessary to perform the Services set forth in the Terms.
b. For the proper management and administration of Business Associate or to carry out its legal responsibilities, provided that: (i) any disclosures are Required By Law; or (ii) Business Associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and be used or further disclosed only as Required By Law or for the purposes for which it was disclosed, and the person agrees to notify Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.
c. To provide Data Aggregation services relating to the Health Care Operations of Covered Entity.
d. To create de-identified health information in accordance with the de-identification requirements of the HIPAA Privacy Rule at 45 C.F.R. § 164.514(a)-(c). Business Associate may use and disclose such de-identified information for any purpose permitted by law, without any obligation to Covered Entity.
3.2. Minimum Necessary. Business Associate agrees to make uses and disclosures of, and requests for, PHI consistent with the minimum necessary requirements of the HIPAA Rules. In the absence of specific guidance from Covered Entity, Business Associate may use its reasonable judgment to determine the minimum necessary PHI required to perform the Services.
4. Covered Entity Responsibilities.
4.1. Representations and Warranties. Covered Entity represents and warrants that, at all times during the term of this BAA: (i) it meets the definition of a “Covered Entity” under the HIPAA Rules; (ii) it has obtained and will maintain any and all consents, authorizations, or other permissions required by the HIPAA Rules or other applicable law necessary for Business Associate to receive, use, and disclose PHI to perform the Services; and (iii) the PHI provided to Business Associate is accurate, complete, and has been collected and disclosed in full compliance with all applicable laws.
4.2. Notice of Limitations. Covered Entity shall notify Business Associate of any limitation(s) in its notice of privacy practices, of any changes in, or revocation of, permission by an Individual to use or disclose his or her PHI, or of any restriction on the use or disclosure of PHI to which Covered Entity has agreed, to the extent that such limitation, change, revocation, or restriction may affect Business Associate’s use or disclosure of PHI.
4.3. Permissible Requests. Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule if done by Covered Entity itself.
5. Term and Termination.
5.1. Term. This BAA shall be effective as of the date Covered Entity accepts the Terms and shall continue until this BAA or the Terms are terminated.
5.2. Termination for Cause. Upon a party’s knowledge of a material breach by the other party, the non-breaching party shall provide an opportunity for the breaching party to cure the breach or end the violation within thirty (30) days. If the breaching party does not cure the breach or end the violation within the specified time, the non-breaching party may terminate this BAA and the Terms. If a cure is not feasible, the non-breaching party may immediately terminate this BAA and the Terms.
5.3. Automatic Termination. This BAA will terminate automatically and immediately upon the termination or expiration of the Terms.
5.4. Obligations Upon Termination. Upon termination of this BAA for any reason, Business Associate shall, if feasible, return or destroy all PHI in its possession. If such return or destruction is not feasible, Business Associate shall extend the protections of this BAA to such PHI and limit further uses and disclosures to those purposes that make the return or destruction infeasible. Covered Entity agrees that Business Associate may retain one archival copy of PHI as necessary for its legal and administrative responsibilities. Covered Entity shall be responsible for any reasonable costs incurred by Business Associate in returning or destroying PHI.
5.5. Survival. The respective rights and obligations of the parties under Section 5.4 and Section 6 shall survive the termination of this BAA.
6. Miscellaneous Provisions
6.1. Regulatory References. A reference in this BAA to a section in the HIPAA Rules means the section as in effect or as amended.
6.2. Amendment. The parties agree to amend this BAA as necessary to comply with the requirements of the HIPAA Rules. Should the parties fail to agree to an amendment required for compliance, either party may terminate this BAA upon thirty (30) days’ written notice.
6.3. Governing Law and Venue. This BAA shall be construed in accordance with the HIPAA Rules. To the extent not preempted by federal law, this BAA shall be governed by and construed in accordance with the internal laws of the State of Wisconsin without giving effect to any choice or conflict of law provision. Any legal suit, action, or proceeding arising out of this BAA shall be instituted exclusively in the federal or state courts located in the State of Wisconsin, and each party irrevocably submits to the exclusive jurisdiction of such courts.
6.4. Assignment; Subcontracting. Covered Entity may not assign its rights or delegate its obligations under this BAA without the prior written consent of Business Associate. Business Associate may assign this BAA in connection with a merger, acquisition, or sale of all or substantially all of its assets. Business Associate may subcontract its obligations hereunder, provided that it complies with Section 2.5 of this BAA. This BAA shall be binding on the parties and their respective successors and permitted assigns.
6.5. Relation to Terms. This BAA supplements the Terms. In the event of a conflict between any provision of this BAA and a provision of the Terms concerning the treatment of PHI, the provision of this BAA shall control.
6.6. No Third-Party Beneficiaries. Nothing in this BAA shall confer upon any person other than the parties and their respective successors or assigns any rights, remedies, obligations, or liabilities whatsoever.
6.7. Indemnification. To the fullest extent permitted by law, Covered Entity shall indemnify, defend, and hold harmless Business Associate and its affiliates, officers, directors, employees, agents, successors, and assigns from and against any and all claims, actions, judgments, liabilities, damages, losses, costs, and expenses, including reasonable attorneys’ fees, fines, and penalties (collectively, “Losses”), arising out of or related to: (a) any breach of this BAA by Covered Entity or its agents; (b) any negligence or willful misconduct by Covered Entity in connection with its obligations under the HIPAA Rules; or (c) any failure by Covered Entity to obtain the necessary consents or authorizations for Business Associate’s use and disclosure of PHI as permitted by this BAA.
6.8. Limitation of Liability. IN NO EVENT SHALL BUSINESS ASSOCIATE’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS BAA, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE TOTAL OF THE AMOUNTS PAID BY COVERED ENTITY TO BUSINESS ASSOCIATE UNDER THE TERMS IN THE SIX (6) MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO THE CLAIM. IN NO EVENT SHALL BUSINESS ASSOCIATE BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES.
6.9. Entire Agreement. This BAA, together with the Terms, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior oral or written understandings.