MOTIVA® WOMAN’S CHOICE PROGRAM TERMS AND CONDITIONS

This document (the “Terms & Conditions”) describes the terms, conditions, and claim procedure for the Motiva Implants® Woman’s Choice Program (the “Program”). Subject to these Terms & Conditions, the Program is offered by Establishment Labs S.A., with registered office at 4th Street, Coyol Free Zone #B15, Alajuela 20102, Costa Rica, and its affiliates (collectively, “Manufacturer”) and is available to individuals implanted with Motiva Ergonomix2® breast implants (the “WCP Participants”) purchased directly from Manufacturer or its authorized distribution partners specifically via the JOY® branded product offering, as evidenced by product serial numbers permitting registration for the Program (the “Qualified Implants”). The Program is intended to enable WCP Participants’ choice by providing the financial support indicated in these Terms & Conditions in the event a WCP Participant elects to remove the Qualified Implants during the Program Validity Period (defined below). There is no additional cost to WCP Participants to participate in the Program provided that the eligibility and registration requirements contained in these Terms & Conditions are fully satisfied and the Validity Period remains in effect.

PROGRAM OVERVIEW & PROGRAM CREDIT

Under the Program and subject to these Terms & Conditions, an eligible WCP Participant who elects for any reason to have a Qualified Explantation (as defined in Section 2 below) can receive financial support (the “Program Credit”) towards the cost of such Qualified Explantation, as further described below. Except where limited or prohibited by law, the Program Credit shall comprise a payment of up to One Thousand Five- Hundred US Dollars (USD $1500) or its equivalent in local currency at the conversion rate in effect on the actual date of payment as determined by Manufacturer in its sole discretion, and without reimbursement for currency fluctuations or bank transaction fees. For further details on the Program Credit, see Section 7 (Payment) below.

Where legally permissible and authorized by Manufacturer, a WCP Participant may have the option to direct that the Program Credit be issued to a licensed medical professional or clinic to directly offset the costs associated with explanting the Qualified Implants.

ELIGIBILITY

A WCP Participant’s eligibility to receive a Program Credit is strictly subject to compliance with the following criteria and the Claim procedure referenced in Section 6 below. An explantation procedure for removal of the Qualified Implants which satisfies all of the below eligibility conditions and is not otherwise excluded under Section 3 below shall be referred to as a “Qualified Explantation.

  1. Each WCP Participant must duly register the Qualified Implants via the MotivaImagine® App, the online registration link or QR code provided to the WCP Participant, or otherwise via the Manufacturer’s MotivaImagine website at https://motiva.health/motivaImagine/, within ninety (90) calendar days following the original implantation procedure (the “Registration Deadline”). The WCP Participant is solely and exclusively responsible for completing and submitting the Program-specific online registration form, complying with the 90-day Registration Deadline, and collecting the Qualified Implants’ serial numbers from the implanting physician or clinic to enable registration in advance of such Registration Deadline. In no event shall Manufacturer or its representatives be liable or responsible for any failure to successfully transmit any online registration link to a WCP Participant due to incorrect email address, Junk/SPAM filtering, service level disruption or other factors. The WCP Participant may submit a registration support ticket via Manufacturer’s website at Motiva Woman’s Choice Program Terms & Conditions (Rev. 2022.03.09) Page 2 of 8 https://motiva.health/patients-contact/ to assistance with registration prior to the Registration Deadline. Neither Manufacturer nor its representatives is able to provide implant serial numbers to be used for registration, as they must be obtained from the implanting surgeon only.
  2. By registering for the Program and/or initiating any Claim, each WCP Participant accepts and agrees to comply in full with these Terms & Conditions.
  3. A WCP Participant must elect to have the Qualified Implants completely and permanently removed, and actually undergo the Qualified Explantation procedure during the Validity Period in order to claim the Program Credit.
  4. Any explantation procedure which is covered in whole or in part by private, public, government or social insurance benefits or reimbursement is explicitly excluded from the Program and will not qualify for the Program Credit.
  5. If the WCP Participant received two (2) Qualified Implants, both Qualified Implants must be explanted to receive the Program Credit.
  6. The WCP Participant must not intend to receive, actually receive, or undergo a revision surgery involving, any replacement, substitute, new or alternate breast implants (of any manufacturer) and must intend to remove the Qualified Implants to remain without breast implants indefinitely.
  7. In order to limit fraud, misrepresentation and abuse, the explantation procedure must be performed by appropriately qualified and licensed medical professionals who affirm their adherence to these Terms & Conditions, as set forth in the Claim forms (each, an “Explanting Clinician”). See Section 5 below for more information.

EXCLUSIONS AND LIMITATIONS

The following Program exclusions apply:

  1. The Program is not valid in any jurisdiction in which the JOY branded product offering is unavailable (including but not limited to Japan), or to any individual who received Motiva Ergonomix2 or other breast implants from surgeons or distribution channels not authorized by Manufacturer to offer the JOY branded program, even if the applicable implants are successfully registered within Manufacturer’s systems or records. Any registration of Ergonomix2 or other breast implants received outside of the JOY branded program shall be valid only with respect to otherwise applicable Manufacturer benefit programs and the registrant shall not comprise a “WCP Participant” as defined in these Terms & Conditions.
  2. The Program is void where prohibited by law and has no cash value. For purposes of eligibility for Program registration, the location of implantation shall control. For purposes of initiating a Claim and receiving the Program Credit, the location of explantation and/or the WCP Participant’s residence shall control to verify compliance with applicable laws for a Program Credit to be issued to the Explanting Clinician or the WCP Participant, respectively. Based on the foregoing, and whether prohibited by law or these Terms & Conditions, if a WCP Participant is ineligible either to register or to receive the Program Credit in their geographic location, the Claim shall be denied in either case.
  3. In no event shall the Program Credit be remitted in advance of the Qualified Explantation. WCP Participants seeking a Program Credit are encouraged to complete the pre-qualification portion of the Claim procedure referenced in Section 6 below to confirm eligibility, including in connection with receipt of genuine Qualified Implants, valid Program registration in advance of the Registration Deadline, no local exclusion, continuity of the Validity Period, non-use of an Excluded Clinic, and other Qualified Explantation criteria as set forth herein. For the avoidance of doubt, the Qualified Explantation must be performed within the Validity Period to qualify for the Program Credit.
  4. The Program will not apply to any Qualified Implants implanted, or explantations performed, without adherence to Manufacturer’s then-current Directions for Use (DFU) and surgical manuals applicable to the Qualified Implants.
  5. The Program only applies to the surgical procedure for the complete and permanent removal of the Implants. By accepting these Terms & Conditions, WCP Participants acknowledge that there may be other procedures that may be necessary or appropriate in the medical professional’s judgment (such as the replacement or revision of the Qualified Implants or other medical or surgical procedures) and which are not covered by the Program or Program Credit.
  6. The Program will not apply in case the removal of the Qualified Implants is totally or partially covered by a private or public insurance, reimbursement system, or similar scheme. Therefore, Manufacturer will deny the award of the Program Credit to any WCP Participants who benefit from total or partial private or public insurance, reimbursement system, or similar scheme covering the removal of the Qualified Implants. Manufacturer reserves the right to investigate and request restitution of any amount provided in relation to WCP Participants who benefit from private or public insurance, reimbursement system, or similar scheme for the removal of the Qualified Implants.
  7. The Program applies to Qualified Explantation procedures performed by Explanting Clinicians who have adhered to these Terms & Conditions. Manufacturer may, in its sole and absolute discretion, decline to issue the Program Credit (a) to any medical professional or clinic that: (i) is not licensed to perform Qualified Explantation procedures in the applicable WCP Participant’s location, (ii) has been debarred, excluded from any government healthcare program, or subject to any disciplinary action or legal enforcement action relating to the practice of medicine or surgery, fraud or abuse of public or private funds, corruption or bribery, crimes of moral turpitude, regulatory violations (including off- label use of medical devices or pharmaceuticals), or violent crimes, (iii) in Manufacturer’s sole and absolute discretion, is suspected of engaging in fraud or abuse relating to the Program and/or any Manufacturer warranty, or (iv) raises concerns, in Manufacturer’s sole and absolute discretion, with respect to compromising patient safety (e.g., as a result of patient complaints or similar evidence) and/or the safe and effective use of Manufacturer’s products (an “Excluded Clinic”); or (b) directly to any WCP Participant who elects to have the Qualified Implants removed at an Excluded Clinic. If a WCP Participant’s Claim is denied at the pre-qualification stage of the Claim procedure referenced in Section 6 below solely on the basis that an Excluded Clinic was selected as the Explanting Clinician, such WCP Participant may re-apply for the Program Credit after selecting an alternate Explanting Clinician. It is the WCP Participant’s sole responsibility to verify that the Explanting Clinician is not an Excluded Clinic by initiating a Claim and obtaining Manufacturer’s determination of pre-qualification prior to undergoing the explantation procedure in order preserve eligibility for the Program Credit.
  8. Manufacturer reserves the right, in its sole discretion, to deny the issuance of multiple Program Credits to any individual WCP Participant, including but not limited to any WCP Participant who elects to purchase new Qualified Implants (i.e., excluding any implants received as part of a Manufacturer warranty or replacement program) at any time after previously undergoing a Qualified Explantation for which a Program Credit was remitted.
  9. Except as explicitly set forth in this paragraph, WCP Participants may not combine the Program Credit with any other benefits offered by Manufacturer, including warranty benefits. Issuance of the Program Credit shall disqualify a WCP Participant from receiving any additional claimed benefits under any other Manufacturer warranty or benefit program with respect to the applicable Qualified Implants, including with respect to any procedures performed prior to the issuance of the Program Credit. Notwithstanding the foregoing, a WCP Participant shall remain eligible for a Program Credit if such WCP Participant (or their surgeon) applies for and receives Manufacturer warranty benefits or other benefits offered by Manufacturer’s polices from time to time; provided, however, that the Validity Period shall not be extended in such cases. For clarification, if a WCP Participant receives any no- cost replacement implant under any Manufacturer warranty program covering the originally implanted Qualified Implants, the applicable Validity Period to complete a Claim procedure to qualify for a Program Credit with respect to a Qualified Explantation to remove the replacement implants shall be calculated from the implantation date of the originally registered Qualified Implants and not from the date of implantation of the replacement implants offered under Manufacturer’s warranty programs.

INDEPENDENT PROGRAM; NO WARRANTY

The Program, while included as part of the JOY branded product offering, is a stand-alone and independent policy which is unrelated to and not part of the Qualified Implants’ separate warranties. The Qualified Implants may be subject to Manufacturer’s standard and extended warranty programs, which remain unaffected by this Program. For full warranty terms, please click visit: https://motiva.health/patients-product-warranty/:

The Program is also separate from any contract between the WCP Participant and third parties, including any medical professionals or institutions for providing surgical services to the WCP Participant, and does not limit or exclude any warranties or representations established under such contracts. Manufacturer is neither part of any contract between the WCP Participant and third parties, including for surgical services to implant or remove Qualified Implants, nor does Manufacturer advise or otherwise influence such third parties or the WCP Participants with regard to any surgical services in connection with the Manufacturer’s products. The Program is intended as a courtesy benefit to support WCP Participants’ health and well-being and is not intended, and shall not to the maximum extent permitted by law, be construed as a promotional practice, kickback, rebate or reward.

EXPLANTING CLINICIANS; FIXED BENEFIT AMOUNT

In certain jurisdictions, WCP Participants may be able to locate potential Explanting Clinicians via the Manufacturer’s searchable medical professional locator database, available at: https://motiva.health/app/center-locator/. In relation to the Program, listed medical professionals may be tagged with one or more symbols designating the following:

  • Clinicians who have independently offered to perform a Qualified Explantation at no additional cost above the Program Credit specifically for patients originally receiving Qualified Implants from their clinic*
  • Clinicians who have independently offered to perform a Qualified Explantation for any WCP Participants at no additional cost above the Program Credit*

    * Applies to Qualified Explantation only excluding any ancillary procedures which may be otherwise medically necessary or recommended by the Explanting Clinician. Discuss definitive costs, including any patient out-of-pocket apportionment, with your Explanation Clinician in advance of the procedure.

For the avoidance of doubt, the physicians and clinics listed in Manufacturer’s searchable database are not complete or exhaustive and Manufacturer cannot guarantee that the information represented by third party clinicians on its website is current or accurate. Consumers must verify all information, including pricing and explantation costs, with their selected clinician directly. Manufacturer does not endorse, approve, favor or recommend any particular medical professionals and does not offer any medical advice, background or licensing checks, or recommendations. In no event shall Manufacturer or its affiliates or representatives be liable or responsible with respect to the performance of any clinical procedure by a third party healthcare professional, including but not limited to claims of malpractice. Subject to Section 3.7 above, any medical professional who complies with these Terms & Conditions and affirms the truthful and accurate submission of Claim data may qualify as an Explanting Clinician for purposes of the Program, including physicians not listed in the online locator database.

WCP Participants are encouraged to seek the advice of a licensed medical professional with respect to clinical judgment, patient safety and suitability for any medical procedure, potential risks and benefits of any Qualified Explantation, procedure recovery times, prescription of medication or anesthesia, and related matters. Each WCP Participant’s healthcare provider should advise whether any ancillary procedures are or are not necessary or preferred in connection with a Qualified Explantation for either health or aesthetic purposes.

Manufacturer does not set or influence any medical professionals’ procedural or service costs, overhead or facility costs. The Program Credit is fixed independent of the aggregate cost of the Qualified Explantation. Accordingly, WCP Participants are encouraged to discuss all procedure, medication and facility costs with one or more medical professionals in addition to seeking the Program Credit. Manufacturer is not liable to any WCP Participant or third party for the cost of any procedure (including explantation) not covered by or within the Program Credit, or for which a Claim was denied for noncompliance with these Terms & Conditions.

CLAIM PROCEDURE

WCP Participants may initiate a request for a Program Credit (a “Claim”) by visiting: https://motiva.health/patients-contact/. Both the WCP Participant and the Explanting Clinician must verify the criteria in Sections 2 and 3 above as part of Claim process. Manufacturer may, in its sole discretion, require the submission of supporting documentation in order to validate and/or document any eligibility criteria, the absence of exclusion criteria or compliance with applicable laws or regulations prior to approving any Claim. All Claims must be initiated prior to the conclusion of the Validity Period and full verification details must be submitted no later than 180 days following the conclusion of the Validity Period to qualify for the Program Credit.

All Claims shall be subject to an initial pre-qualification check which, if approved, must be followed by a verification submission following the Qualified Explantation to confirm eligibility to receive the Program Credit.

As part of the initial pre-qualification step in the Claim procedure, the WCP Participant must submit, among other things,

  • Accurate information or documentation to verify the WCP Participant’s identity, receipt of Qualified Implants and timely registration for the Program prior to the Registration Deadline, such as the device serial and lot numbers and registration e-mail address. Such information can be derived from electronic records, transponder readings, and Qualified Implants purchase and delivery records with the help of the medical professional that performed the implantation.
  • The WCP Participant’s location of implantation and proposed location of explantation, in order to verify geographical eligibility.
  • The name, clinic address, telephone number and email address of the Explanting Clinician in order to confirm such Explanting Clinician is not an Excluded Clinic;
  • An acknowledgement that the WCP Participant has no plans to, and shall not, receive any substitute or replacement breast implants in connection with the explantation procedure or at any point in the future.
  • Confirmation that the explantation procedure shall not be covered by private or public insurance, reimbursement system, or any similar scheme.

As part of the verification step in the Claim procedure, each WCP Participant and designated Explanting Clinician must affirm, among other things, that all facts in the Claim are true and correct, that a Qualified Explantation was duly completed within the Validity Period, that the explantation procedure was not covered by insurance or healthcare program reimbursement, and that the WCP Participant did not receive replacement or substitute breast implants from the Explanting Clinician or any other medical professional in connection with the explantation or otherwise. Each of the WCP Participant and Explanation Clinician must further acknowledge the designated payee of the Program Credit and the bank account to which the Program Credit will be remitted. Manufacturer may, in its sole and absolute discretion, require proof of invoice or other documentation to evidence the completion and/or cost of the Qualified Explantation.

Manufacturer shall engage in commercially reasonable efforts to issue a determination with respect to pre- qualification eligibility and/or final Claim verification and approval within fifteen (15) business days following complete and accurate submission of all information requested under the Claim procedure and associated forms. If any of the required eligibility or verification information is missing or incomplete or requires additional review or verification, Manufacturer will make up to three (3) attempts to reach the WCP Participant via such WCP Participant’s indicated e-mail address in order to request the missing, incomplete or supporting details to enable Manufacturer to make a determination pursuant to these Terms & Conditions. If no response is received after the third attempt or if the WCP Participant fails to submit all requested information within a reasonable period not to exceed 180 days following the conclusion of the Validity Period, Manufacturer will deny and close the Claim, subject to such WCP Participant’s statutory rights under applicable laws. Each WCP Participant is responsible for causing their designated Explanting Clinician to timely complete and submit the Claim form(s) required to be submitted by the Explanting Clinician. No Program Credit shall issue unless the Explanting Clinician has submitted verification of the Qualified Explantation.

Manufacturer reserves the right to investigate and request additional evidence and documentation, particularly in the event of large numbers of Claims made with respect to a particular medical professional or medical institution. Additional time required for such investigation and request shall not affect the WCP Participant’s Claim.

For guidance on providing the necessary information and verification documentation, WCP Participants and their medical professionals may request support here: https://motiva.health/patients-contact/. Manufacturer encourages WCP Participants to submit and resolve any questions related to their eligibility for the Program before a removal surgery is scheduled.

PAYMENT

Subject to the criteria and exclusions in these Terms & Conditions, the Program Credit shall be remitted in the amount of the lesser of: (a) One-Thousand Five Hundred U.S. Dollars (USD $1500) or (b) the actual fees charged by the Explanting Clinician for the Qualified Implantation (as converted to U.S. Dollars applying the conversion rates of Manufacturer’s bank). Manufacturer shall issue the Program Credit within sixty (60) calendar days of its final approval and verification of a Claim. The WCP Participant and explanting medical professional shall agree ahead of the Qualified Explantation whether the Program Credit shall be granted in the form of a reimbursement paid to either the WCP Participant or the medical professional.

Manufacturer shall remit the Program Credit by wire transfer or bank transfer in U.S. Dollars, which may be converted by the recipient’s bank or any intermediary bank into the local currency of the receiving bank. Manufacturer shall bear any costs charged by its own bank(s) in connection with the issuance of the Program Credit. The WCP Participant (or explanting medical professional, depending on the case) shall bear any fees charged and deductions made by their own bank, and by any third-party banks involved in the transfer, including any costs or deductions related to currency conversions. Manufacturer is not responsible for any currency fluctuation risk, sending or receiving bank conversion rates, wire transfer fees or other fees charged by the bank receiving the Program Credit or any intermediary banks.

The WCP Participant is solely responsible for providing accurate and complete information within the Claim procedure regarding the payee bank account to which the Program Credit shall be remitted. Manufacturer is not responsible for any errors, typographical or otherwise, in the payee information or in the misdirection of funds due to such error. Manufacturer’s sole obligation with respect to the remittance of the Program Credit shall be to wire or otherwise initiate a funds transfer in the amount of the Program Credit to the payee information exactly as listed in the Claim verification. Manufacturer shall have no obligation to reverse any payment, recover any lost or misdirected funds or duplicate any payment not received by the intended payee for any reason other than Manufacturer’s sole and direct error. Manufacturer shall have no liability in respect of payments or debts owed between a WCP Participant and their designated Explanting Clinician. If the Program Credit is remitted directly to any WCP Participant, such WCP Participant is solely responsible for remitting full payment to their Explanting Clinician for any costs associated with the Qualified Explantation. If the Program Credit is remitted to the Explanting Clinician, the WCP Participant shall directly coordinate with the Explanting Clinician to ensure appropriate credit to their invoice or account.

If the Program Credit is determined by Manufacturer to be contrary to applicable laws in the WCP Participant’s jurisdiction, Manufacturer may, in its sole and absolute discretion, offer a discount coupon, voucher, gift card, clinic account credit or similar value alternative in lieu of the Program Credit, or may deny the claim for the Program Credit without penalty or compensation.

The WCP Participant shall be solely responsible for the payment of any taxes or tax liabilities associated with receipt of the Program Credit or its equivalent and shall pay any and all income, value added, stamp, or similar taxes that are due and payable under applicable laws or tax codes in the WCP Participant’s jurisdiction.

PROGRAM VALIDITY PERIOD

With respect to each WCP Participant, the Program Credit benefit shall be available for a period of two (2) years from the date of the original implantation of a Qualified Implant (without regard to any later revision surgery dates) or such shorter period as determined by Manufacturer consistent with this Section (the “Validity Period”). Subject to applicable laws, Manufacturer reserves the right to modify, cancel, update, terminate, limit or otherwise discontinue (each, a “Modification”) the Program at any time, without notice to or consent of the WCP Participant or any third party, and including with effect to WCP Participants who previously registered for the Program prior to the Modification. Unless and to the extent retrospective Modification is prohibited by applicable law in respect to a particular WCP Participant’s case, the most recent version of these Terms & Conditions available on Manufacturer’s website shall govern and control all Program benefits applicable to such WCP Participant. Notwithstanding the foregoing, in no event shall the Validity Period exceed two (2) years from the date of the WCP Participant’s initial implantation with the Qualified Implants.

Where Manufacturer initiates a Modification applicable to WCP Participants that have previously registered for the Program, Manufacturer will engage in reasonable efforts to provide notice of such Modification to such WCP Participants in writing via the email addresses associated with the WCP Participants’ registration accounts and/or via the Manufacturer website and such WCP Participants shall have the right to terminate their participation in the Program upon receipt of any such notice. Nothing contained in these Terms & Conditions or any other instrument shall be construed as an obligation of Manufacturer to maintain the Program for any particular period of time.

FURTHER TERMS

To the maximum extent permitted by applicable law, the rights of WCP Participants under the Program are non-transferable, non-contractual and non-promotional. Registration for the Program by a WCP Participant comprises an opt-in to the then-available Program benefits and does not create a binding contract between Manufacturer and any WCP Participant as of any particular date.

The Program and these Terms & Conditions, including any obligations, rights, and claims arising out of or in connection with them, any questions regarding valid conclusion of agreements under these Terms & Conditions, and any amendments thereto – irrespective of their legal grounds (e.g., under contract, tort or otherwise) – shall be exclusively governed by and construed in accordance with the laws of Costa Rica, excluding its conflicts of laws provisions, and the courts located in San Jose, Costa Rica will have exclusive jurisdiction on potential disputes. If the WCP Participant is a consumer within the meaning of the Regulation (EC) No. 593/2008, i.e., if the WCP Participant accepts these Terms & Conditions by registering for the Program for a purpose which can be regarded as being outside their trade or profession, the foregoing choice of governing law shall not have the result of depriving the WCP Participant of the protection afforded to them by provisions that cannot be derogated from by agreement by virtue of the law of the country where the WCP Participant has their habitual residence. Solely in such scenario, WCP Participants will be entitled to bring claims before the courts of the place of their habitual residence.

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[1] The information provided is for informational and educational purposes only, the content herein is not intended as a substitute for consultation with a physician. Motiva® Implants are not yet commercially available in the US and are undergoing clinical investigation pursuant to US Food and Drug Administration (FDA) regulations for investigational medical devices.
[2] The statements and opinions presented here are applicable to each individual. Results will vary and may not be representative of the experience of others. All statements are voluntarily provided and are not paid, nor were they provided with free products, services, or any benefits in exchange for said statements. The statements are representative of patient experience; the exact results and experience will be unique and individual to each patient.