Exhibit 10.4
Certain identified information has been excluded from this exhibit pursuant to Item 601(b)(10)(iv) of Regulation S-K under the Securities Act of 1933, as amended, because the
Registrant customarily and actually treats that information as private or confidential and the omitted information is not material. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***].”
THIRD AMENDED AND RESTATED DISTRIBUTION AGREEMENT
(hereinafter the “Agreement”)
between
vVARDIS Inc.
99 Wall Street
Suite 1836
New York, NY 10005
(hereinafter “Supplier”)
vVARDIS Holding AG
Gubelstrasse 24, 6300 Zug, Switzerland
(hereinafter “Supplier Parent”)
and
Henry Schein, Inc.
135 Duryea Road
Melville, NY 11747
(hereinafter “Distributor”).
Effective as of August 19, 2024 (the “Effective Date”), with a First Amendment and Restatement Date of December 20, 2024 (the “First Amended and Restated Effective Date”), a Second Amendment and Restatement Date of November 29, 2025 (the “Second
Amended and Restated Effective Date”) and a Third Amendment and Restatement Date of September 29, 2026 (the “Third Amended and Restated Effective Date”)
1. Parties
1.1 Supplier is a corporation incorporated and existing under the laws of Delaware with its registered office in New York, New York. Supplier Parent is a limited liability company incorporated and existing under the
laws of Switzerland with its registered office in Zug, Switzerland. Supplier Parent and Supplier’s affiliates manufacture materials and related components for dental, oral, maxillofacial and periodontal applications and the Supplier and its
affiliates distribute them worldwide.
1.2 The Distributor is a corporation incorporated and existing under the laws of the state of Delaware with its principal place of business at 135 Duryea Road, Melville, NY 11747. Distributor and Supplier will
hereinafter be referred to as the “Parties”.
1.3 The Parties entered into a Distribution Agreement on August 19, 2024 (the “Original Agreement”), amended and restated the Original Agreement as of December 20, 2024 (the “First Amended and Restated Agreement”) to
memorialize certain changes agreed to by the Parties, and further amended and restated the Original Agreement and the First Amended and Restated Agreement as of November 29, 2025 (the “Second Amended and Restated Agreement”) to memorialize certain
further changes agreed to by the Parties. The Parties now agree to further amend and restate the Original Agreement, the First Amended and Restated Agreement and the Second Amended and Restated Agreement (the “Third Amended and Restated Agreement”)
to memorialize certain changes agreed to by the Parties, including to provide that this Agreement addresses solely the sale of Products by Supplier to Distributor and the distribution and resale of such Products by Distributor.
1.4 Supplier is the manufacturer of the Products. Supplier sells the Products to Distributor, and Distributor takes title to and possession of the Products so purchased and resells such Products for Distributor’s own
account and in Distributor’s own name to Distributor’s customers.
1.5 Subsidiaries of Distributor may, at the direction of Distributor, exercise any of the rights, or assume any of the duties, of Distributor hereunder, provided that Distributor shall be responsible for the
performance of, and the adherence to this Agreement by, any such subsidiaries. Distributor will enforce compliance with the terms of this Agreement with its subsidiaries and controlled affiliates.
1.6 Each of Supplier Parent, Supplier and Distributor have entered into the international Distribution Agreements described on Appendix K (as the same may be amended, supplemented or otherwise modified, the
“International Distribution Agreements”), the Note Purchase Agreements described on Appendix K (as the same may be amended, supplemented or otherwise modified, the “Note Purchase Agreements”) and the Security Agreements described on Appendix K (as
the same may be amended, supplemented or otherwise modified, the “Security Agreements”). Supplier Parent and Distributor have also entered into those certain Parent Guarantee Agreements described on Appendix K (as the same may be amended,
supplemented or otherwise modified, the “Guarantees”) and vVARDIS Inc. and Distributor have entered into the Notes as described on Appendix K (as the same may be amended, supplemented or otherwise modified, the “Notes” and together with the
International Distribution Agreements, Note Purchase Agreements, the Guarantees and the Security Agreements, the “Transaction Documents”).
1.7 Unless otherwise noted herein, “Supplier” shall mean collectively Supplier Parent and Supplier.
2. Representations and Warranties
2.1 Each of Supplier, Supplier Parent and Distributor hereby represents and warrants:
2.1.1 It has been duly organized, is validly existing, and is in good standing under the laws of its jurisdiction of formation.
2.1.2 It has the full right, power and authority to enter into and perform its obligations under this Agreement and the Transaction Documents.
2.1.3 The execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate or organizational approvals.
2.1.4 This Agreement constitutes a legal, valid and binding obligation of each party, enforceable against it in accordance with its terms.
2.2 Each of Supplier and Supplier Parent hereby represents and warrants that the execution, delivery and performance of this Agreement does not violate or breach any of the terms of any of the loan facility documents
to which OrbiMed Royalty & Credit Opportunities IV, LP (or any other affiliate thereof), Supplier and/or Supplier Parent are parties (the “OrbiMed Loan Documents”).
3. General Agreement
3.1 Supplier and its subsidiaries are the owners of all manufacturing and distribution rights for Curodont Repair Fluoride Plus and Curodont Protect and, in the case of each such product, any future iterations,
improvements and advances thereto and products or developments ancillary or related thereto (as more fully described on Appendix A, hereinafter, individually “Curodont Repair” and “Curodont Protect” and collectively together, the “Products”).
3.2 Supplier agrees not to private label Products similar or competitive to the Products for third parties, in the Dental Market in the Territory during the Term, either directly or through a subsidiary, affiliate or
third party. Except as expressly authorized under Section 3.6 of this Agreement, Supplier agrees not to sell, market or distribute the Products to any third party in any country in the Territory (defined below) for which Distributor has been
granted exclusive distribution rights to the Products during the Term either directly or through a subsidiary, affiliate or third party.
3.3 Subject to Section 3.6 below, Supplier agrees that Distributor shall hereby have exclusive distribution rights to the Products in the Dental Market in the United States of America (“Exclusivity”). Supplier also
agrees that other than (i) UK where Distributor has exclusive distribution rights for the Product which rights shall be extended until December 31, 2026 and (ii) any future exclusive arrangements negotiated between the parties, Supplier agrees that
Distributor shall have non-exclusive distribution rights to the Product in all countries outside United States of America in which Supplier has entered in the market.
3.4
(a) At such time as Supplier or any subsidiary or affiliate thereof is considering entering into an exclusive distribution arrangement with respect to the Products in any of Australia, Canada, Germany, France, Italy or Spain, Supplier
agrees to discuss and negotiate in good faith with Distributor the terms and conditions of a potential exclusive distribution agreement, including minimum sales targets. If Distributor and Supplier are unable to agree on such terms, for six months
after conclusion of such discussions, Supplier will not enter into an exclusive agreement for the Products with any other distributor on terms and conditions, which when taken as a whole (including minimum sales targets), are more favorable than
those offered to Distributor during such discussions. In any other international countries in which Supplier is considering entering into an exclusive arrangement for the Products (or in which Distributor is interested in entering into an exclusive
arrangement for the Products) Distributor and Supplier agree to discuss proposed terms and conditions for such an arrangement in good faith. “Territory” shall mean the United States and any other country in which Distributor has distribution rights
under this Agreement or the Transaction Documents. Distributor represents and warrants that Products purchased for a particular country shall only be sold by Distributor to customers in that particular country. The Distributor agrees on behalf of
itself, its affiliates and subsidiaries, to resell the Products only within the Territory in the “Dental Market” (defined below). “Dental Market” shall include any customers in the dental market, including dentists, dental clinics, dental
institutions, DSOs, dental schools and government entities; provided that the Dental Market shall exclude any customers known to Distributor to be a retail pharmacy, department stores or other retail establishment. To the extent Supplier or
Distributor becomes aware that a customer of Distributor is reselling to any of these excluded markets, Distributor will use its commercially reasonable efforts to address with customer and make clear to such customer that such actions are strictly
prohibited.
(b) At such time as Supplier or any subsidiary or affiliate thereof introduces a new product that does not otherwise meet the definition of “Product” hereunder to the Dental Market (“New Products”) in a country in the Territory, and
provided that an existing exclusive distributor relationship with Distributor has been established with respect to the Products in such country, Supplier agrees to discuss and negotiate in good faith with Distributor the terms and conditions of a
potential exclusive distribution agreement for such New Products, including minimum sales targets. If Distributor and Supplier are unable to agree on such terms, for six months after conclusion of such discussions, Supplier will not enter into an
exclusive agreement for the New Products with any other distributor on terms and conditions, which when taken as a whole (including minimum sales targets), are more favorable than those offered to Distributor during such discussions. In any
countries in which Supplier is not a party to an exclusive distributor relationship for Products with either Distributor or a third party, and Supplier introduces a New Product to the Dental Market in such countries and is considering entering into
an exclusive arrangement for the New Product (or in which Distributor is interested in entering into an exclusive arrangement for the New Product) Distributor and Supplier agree to discuss proposed terms and conditions for such an arrangement in
good faith. During any such time where Supplier does not otherwise have an exclusive distribution agreement with respect to New Products (in compliance with this Section 3.4(b), Supplier agrees to provide Distributor with non-exclusive distribution
rights to the New Products.
3.5 Supplier confirms that promptly after the Second Amended and Restated Effective Date, it notified each distributor and DSO with whom it does business, informing such distributor and DSO that Distributor has exclusivity. At all times during
the Distributor’s Exclusivity, Supplier shall use commercially reasonable efforts to enforce such Exclusivity Rights.
3.6 Notwithstanding Distributor’s Exclusivity, if a DSO customer (defined as [***] locations or more for purposes of this Section 3.6) purchases less than [***]% of their dental supplies or equipment from Distributor, refuses in writing to work
with Distributor and wishes to negotiate purchase price for the Product directly with Supplier (a “Select DSO”), Supplier and the Select DSO will negotiate an agreed retail price for the Product (“Retail Price”). In addition, if a DSO customer
(defined as [***] locations or more for purposes of this Section 3.6) does not otherwise meet the criteria set forth above, but nonetheless refuses in writing to work with Distributor, Supplier will provide Distributor the opportunity to speak
directly to such DSO customer regarding their concerns and each of Distributor and Supplier will work together in good faith to determine how best to serve such DSO customer, and may mutually agree (and such agreement shall not be unreasonably
withheld) in writing to permit such DSO to become a Select DSO for purposes of this Agreement.
With respect to each Select DSO, the Retail Price will be communicated to Distributor in writing. Distributor agrees to sell to the Select DSO at the Retail Price. At the end of each calendar month, Supplier shall pay to Distributor a chargeback
for each Box sold to the Select DSO in an amount equal to the sum of (a) Distributor Wholesale Price (as defined on Appendix A) minus Retail Price and (b) (i) [***]% ([***] percent) for 2026, (ii) [***]% ([***] percent) for 2027, (iii) [***]%
([***] percent) for 2028, and (iv) [***]% for 2029, in each case multiplied by the applicable Retail Price (the “Select DSO Chargeback”). Notwithstanding the foregoing, Distributor shall have the right to refuse sale to any Select DSO Customer to
the extent that, after taking into account receipt of the chargeback, the sale would be unprofitable for Distributor (an “Unprofitable Customer”). If Distributor notifies Supplier of such election in writing, Supplier can use another logistics
provider to supply the Product to the Select DSO; provided however, that if Supplier later changes the Retail Price to such Unprofitable Customer, Supplier shall notify Distributor in writing and provide Distributor with the first offer rights to
sell to the Unprofitable Customer.
3.7 So long as Distributor achieves the minimum number of New Customers (the “Minimum New Customer Threshold”) set forth below in the applicable periods set forth below, Distributor shall maintain Exclusivity for the periods set forth in the
table below. “New Customer” shall mean a customer or purchaser of the Product who (1) has not purchased the Product from any distributor or from Supplier in the [***] months prior to being counted as a New Customer, (2) purchases at least [***]
boxes of Product and (3) whose name, address and email address or phone number have been provided to Supplier.
|
Time Period to Meet Minimum Threshold
|
|
Minimum Threshold of New Customers
|
|
Exclusivity Period
|
|
November 29, 2025 – December 31, 2027
|
|
[***] New Customers
|
|
If this First Minimum New Customer Threshold of [***] is achieved in the time period set forth, exclusivity is maintained through December 31, 2028
|
| |
|
|
|
|
|
November 29, 2025 – December 31, 2028 (applicable only as provided below)
|
|
[***] New Customers
|
|
If this Second Minimum New Customer Threshold is applicable and is achieved in the time period set forth, exclusivity is maintained through December 31, 2029
|
If Distributor has not achieved [***] New Customers during the period between November 29, 2025 and December 31, 2026, Distributor agrees to work with Supplier in good faith to discuss how to better achieve the First Minimum New Customer
Threshold.
If Distributor has not achieved [***] New Customers by December 31, 2027, Distributor shall have until June 30, 2028 to achieve [***] New Customers as measured from November 29, 2025 (the “Cure Period”). If Distributor achieves [***] New
Customers on or before the expiration of the Cure Period, Distributor shall maintain Exclusivity as though the First Minimum New Customer Threshold had been achieved by December 31, 2027. If Distributor has not achieved [***] New Customers by the
expiration of the Cure Period, Supplier shall have the right (but not the obligation) upon [***] days’ prior written notice to terminate Distributor’s Exclusivity hereunder. Upon Supplier’s election to terminate Exclusivity, Distributor shall
(subject to the Exclusivity Tail), lose the Exclusivity but shall maintain non-exclusive distribution rights for the Product in the Dental Market for the remainder of the Term.
The Second Minimum New Customer Threshold shall apply only if Distributor has achieved [***] New Customers on or before the expiration of the Cure Period. If the Second Minimum New Customer Threshold is applicable and Distributor achieves it by
December 31, 2028, then Distributor shall maintain Exclusivity through December 31, 2029. If the Second Minimum New Customer Threshold is applicable and Distributor has not achieved it by December 31, 2028, Supplier shall have the right (but not
the obligation) upon [***] days' prior written notice to terminate Distributor's Exclusivity hereunder.
For the avoidance of doubt, the applicable Minimum New Customer Threshold shall be adjusted on a reasonable basis to reflect any supply disruptions or delays, legal or regulatory issues or delays with respect to the Products, changes to
insurance reimbursement for the Products due to box configuration/quantity changes, any overall material negative change to insurance reimbursement for the Products, any failure by Supplier’s sales support team to use commercially reasonable
efforts to train offices virtually and/or in person, as required by the DSO, within [***] days of onboarding date, as further set forth in Section 15.2, any material adverse publicity regarding the Products’ safety and/or efficacy, or other
extraordinary events affecting the supply of the Products. Distributor’s loss of exclusivity shall be Supplier’s sole and exclusive remedy for Distributor’s failure to meet the Minimum New Customer Threshold.
While Distributor has Exclusivity, the Parties will meet no less than quarterly, but endeavoring to meet more often as needed during the Term (as defined below) to monitor Distributor’s progress against the Minimum New Customer Threshold and
make strategy changes as necessary.
3.8 At the end of Distributor’s Exclusivity, any DSO customer with [***] locations or more who is buying Product from Distributor and for which Distributor has a primary consumables relationship where the majority of the customer’s consumables
are distributed by Henry Schein, (a “HSI DSO Customer”), Supplier shall maintain exclusivity with respect to that HSI DSO Customer for an additional period of one year (the “Exclusivity Tail”). Exclusivity shall immediately terminate for all other
customers and Supplier shall have the right (but not the obligation) to use additional distributors to distribute Product to such customers. Distributor will provide Supplier with a list of HSI DSO Customers and to the extent Distributor and
Supplier disagree as to whether any customer constitutes a HSI DSO Customer as defined in this Agreement after good faith discussions, the disagreement shall be decided by the Independent Arbiter. “Independent Arbiter” shall be an independent
industry expert with at least 15 years of experience in the Dental Market and mutually agreed by Distributor and Supplier. If Distributor and Supplier cannot agree on an industry expert, Distributor and Supplier shall each designate an industry
expert of their choosing and those two industry experts will agree and designate the Independent Arbiter. Such list and information shall be deemed Distributor’s Confidential Information and shall be kept strictly confidential by Supplier.
Notwithstanding the foregoing, if either Supplier or Distributor counsel believes that such list contains competitively sensitive information, Supplier and Distributor’s counsel will work to establish an appropriate clean team to review such
information.
“Boxes” of Product is defined as a box configured with [***] single lesion application packages. If the box configuration or treatment protocol of Curodont Repair Fluoride Plus changes or insurance reimbursement related to the box
configuration/quantities changes, the Parties will work in good faith to adjust the Minimum New Customer Thresholds accordingly.
The Distributor agrees to purchase the Products exclusively from the Supplier and to market, sell and distribute the Products in the Territory to appropriate customers in accordance with their package insert.
During the Exclusivity (including, with respect to HSI DSO Customers that HS wishes to maintain under any Exclusivity Tail), the Distributor agrees for itself, its affiliates, subsidiaries and sub-distributors not to market, sell, invest in, or
distribute any Competitive Products to any customers. “Competitive Products” means: a) any existing product that introduces a new iteration, improvement or advance that treats early carious and incipient carious lesions through arrest,
remineralization and/or regeneration of tooth enamel; and b) any products introduced to the market after the Effective Date that treats early carious and incipient carious lesions through arrest, remineralization and/or regeneration of tooth
enamel, and, in the case of each such product, any future iterations, improvements and advances thereto and products or developments ancillary or related thereto. For avoidance of doubt, (i) any products Distributor or Distributor’s affiliates
currently sell are excluded from this restriction, (ii) other than as set forth in clause (i) this restriction includes silver containing products, fluoride products and/or peptide products that would directly compete against the Products. Any
exceptions must be mutually agreed upon in writing by the parties.
3.9 The Parties acknowledge that Distributor purchases the Products from Supplier for Distributor’s own account and resells such Products to Distributor’s customers, and that the identity of and information concerning such customers is the
Confidential Information of Distributor. Accordingly, Distributor shall have no obligation under this Agreement to disclose to Supplier any information identifying or concerning Distributor’s customers, other than such information as is expressly
required to be provided under this Section 3.9. Distributor shall provide to Supplier (i) the customer name, address and email address or phone number contemplated by the definition of “New Customer” in Section 3.7, solely for the purpose of
verifying and counting New Customers against the Minimum New Customer Threshold; (ii) the list of HSI DSO Customers contemplated by Section 3.8, solely for the purpose of administering the Exclusivity Tail; and (iii) the customer name and address
and such other information as is contemplated by Section 11.3, Section 23.4, Section 23.5, Appendix D and Appendix F, solely for the purposes of complaint handling, adverse event reporting, traceability, recall and field safety corrective action,
and compliance with applicable regulatory requirements (collectively, the information described in clauses (i) through (iii), the “Permitted Distributor Customer Information”).
3.10 All Permitted Distributor Customer Information shall be deemed Distributor’s Confidential Information. Supplier shall use the Permitted Distributor Customer Information solely for the specific purpose for which it was provided as set forth
in Section 3.9 and for no other purpose. Without limiting the foregoing, Supplier shall not, and shall not permit any other person to: (i) sell, license, sublicense, assign, distribute, publish, transfer or otherwise make available the Permitted
Distributor Customer Information to any person; (ii) use the Permitted Distributor Customer Information in any manner or for any purpose that infringes, misappropriates or otherwise violates any intellectual property right or other right of any
third party or that violates any applicable law; or (iii) use the Permitted Distributor Customer Information for purposes of marketing, promoting or distributing Supplier’s or its affiliates products or services, or in relation to any direct or
indirect sales by Supplier or its affiliates to Distributor customers. Nothing in this Agreement shall be construed as granting Supplier any license or other right in or to any information identifying or concerning Distributor’s customers, other
than the limited, purpose-restricted right of use expressly set forth in this Section 3.10.
4. Prepayment of Inventory
4.1 The Parties acknowledge and agree that Distributor has made a prepayment for Product in an amount equal to $15,000,000 (Fifteen Million) by wire transfer to the account set forth in Appendix B (the “Prepayment”), and that Supplier has
received such Prepayment in full. Supplier has provided an invoice and such supporting documentation as Distributor has requested in respect of the Prepayment. As a result of the payment of such Prepayment, Distributor has a $15,000,000 (Fifteen
Million) credit which can be applied to any Product purchase orders made by Distributor commencing July 1, 2026, in a maximum amount equal to $3,750,000 (Three Million Seven Hundred Fifty Thousand) per quarter until fully redeemed and applied by
Distributor (such that if Distributor elected to purchase the full value of Product in each quarter, the entire Prepayment would be redeemed in full by June 30, 2027). As of the Third Amended and Restated Effective Date, the portion of the
Prepayment which remains outstanding and has not otherwise been redeemed for Product by Distributor is $11,250,000. For the avoidance of doubt, the Prepayment shall not be deemed an early payment for purposes of applying the early pay or
pre-payment discount as contemplated in Section 7.6.
Notwithstanding the foregoing, any portion of the Prepayment which remains outstanding and has not otherwise been redeemed for Product by Distributor shall, with immediate effect by written notice from Distributor to Supplier, be accelerated and
immediately repaid to Distributor (in the form of a cash refund or in Product (at Distributor’s election)) in the event that any of the following circumstances occur:
|
(a) |
An Event of Default (as defined in any of the Transaction Documents) occurs and Supplier or Supplier Parent fails to cure such default or breach within the time period specified for such Event of Default, if any, in the applicable
Transaction Documents;
|
|
(b) |
There is a material breach by Supplier or Supplier Parent of this Agreement (including any breach of Supplier’s Exclusivity obligations) and such breach is not cured (if curable) within the applicable cure period, if any, specified in
this Agreement;
|
|
(c) |
This Agreement is terminated;
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|
(d) |
There is a Change of Control (for the avoidance of doubt, an initial public offering and listing on a national stock exchange (e.g. NYSE, NASDAQ) of Supplier or Supplier Parent, or affiliate thereof, including, without limitation,
vVARDIS Holding AG, shall not be deemed a Change of Control for purposes of this Section 4.1(d)); or
|
|
(e) |
Supplier is unable for any reason to deliver Products sufficient to satisfy the Prepayment made by HSI hereunder within [***] days of receipt of a purchase order therefor.
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5. Forecast/Inventory/Sales Targets
The Distributor shall submit to the Supplier rolling, non-binding [***]-month volumes forecasts every month in order to ensure production capacity is available to meet Distributor’s demand.
The Parties will meet monthly during the Term, as set forth in Appendix E, to monitor progress against the Minimum New Customer Threshold to make strategy and execution changes if necessary, including an increase in marketing efforts.
6. Orders
The purchase of the Products shall be made by the Distributor by placing an order with the Supplier at least [***] business days before the requested delivery date. Purchase orders must be placed by an authorized party via email as listed in
Appendix B. Product orders or deliveries within this period must comply with a minimum order value of $[***].
7. Prices; Terms of Payment
7.1 Supplier shall sell the Products to Distributor and Distributor shall pay for the Products in accordance with the terms and conditions set forth below. Prices shall be in accordance with Appendix A. Prices shall remain fixed until [***].
Supplier reserves the right to change its prices at any time thereafter; provided that (i) Supplier must notify Distributor of any Product price increases in writing at least six months in advance of the effective date of such change and (ii) shall
also increase its manufactured suggested retail price (as evidenced on its marketing materials and packaging) by the same corresponding increase. Orders placed after a price change notice but before the effective date of the price change shall not
exceed on a quarterly basis a total of [***]% of the previous full calendar quarter’s average volume, for the last full calendar quarter prior to the notice of the price change unless agreed otherwise with the Supplier. All of the financial terms
between Supplier and Distributor shall be fair market value and in accordance with law. If an increase in the price for any of the Products becomes effective after Distributor submits an order for such Products, but before Supplier has shipped the
Products ordered, the price that Distributor will pay for the Products will be the price in effect when the Distributor submitted its order for the Products. Supplier may decrease the prices for the Products at any time and will promptly notify
Distributor of any price decrease. If the price for Products is decreased after Distributor submits an order for such Products, but before Supplier has shipped the Products ordered, the price Distributor will pay for the Products will be the price
in effect when Distributor ships the Products.
7.2 During the Term, for every Box sold to a DSO Customer (of any size) excluding Select DSO customers, Supplier shall pay Distributor a rebate (“Rebate”) per Box equal to the amounts set forth in the second column of the charts below based on
such DSO Customer’s annual purchasing volume:
FOR PRODUCT PURCHASED PRIOR TO THE SECOND AMENDED AND RESTATED EFFECTIVE DATE:
|
Annual Volume of Boxes Purchased by DSO Customer
|
Rebate per Box
|
|
|
[***] or more Boxes
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
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$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
FOR PRODUCT PURCHASED ON OR AFTER THE SECOND AMENDED AND RESTATED EFFECTIVE DATE THROUGH MARCH 31, 2026:
|
Annual Volume of Boxes Purchased by DSO Customer
|
Rebate per Box
|
|
|
[***] or more Boxes
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
FOR PRODUCT PURCHASED ON OR AFTER APRIL 1, 2026:
|
Annual Volume of Boxes Purchased by DSO Customer
|
Rebate per Box
|
|
|
[***] or more Boxes
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
|
[***] – [***]
|
$[***]
|
|
7.3 Such Rebate per Box shall be increased any time there is a price increase by the corresponding proportional amount, by percentage, of any price increase. Supplier shall pay the Rebate no later than [***] days after each quarter. Distributor
may elect to offset the amount of any unpaid Rebates against any amounts owed to Supplier.
7.4 Notwithstanding anything in this Agreement to the contrary, Supplier shall at all times during the Term provide the Products to Distributor at the lowest Total Cost that such Products are offered to any similarly situated third party but
shall not include Select DSO customers. “Total Cost” means the net cost to the buyer of the applicable goods and services, taking into account, among other things, factors such as price, financing terms, shipping costs, insurance, regulatory fees,
sales support spending, marketing materials, national and cooperative advertising spending, end-user incentives, rebates and technical support.
7.5 Supplier will sell the Products to Distributor at preferred commercial terms in the Territory during the Term, including the most favored nations pricing set forth in Section 7.4 above and exclusive promotions including exclusive promotions
for the independent practice market for a minimum of [***] months. All terms will be in accordance with law.
7.6 If Distributor pays within [***] ([***]) days of invoice, Distributor will receive an early cash-pay discount of [***]%. If, upon request of Supplier, Distributor makes a pre-payment of cash upon submission of a purchase order, Distributor
will continue to receive a pre-payment discount of [***]%. Unless otherwise agreed with Distributor, no invoice may be issued prior to Supplier’s shipment of the Products ordered.
7.7 Interest at the rate of [***]% per annum shall accrue on fees not paid by the Distributor (other than any payments subject to a good faith dispute between the parties) within [***] days after receiving written notice from Supplier that such
payment is past due.
7.8 Payments shall be made by the Distributor within [***] ([***]) days of the invoice date by bank transfer at the Distributor’s expense.
7.9 Notwithstanding anything to the contrary contained herein, if there is an Event of Default (as defined in the Notes, and after taking into account any cure period) or if for any reason any Note is not repaid on time by Supplier in accordance
with its terms, Distributor shall have the right to set off any amounts it owes to Supplier under this Agreement and apply towards repayment of such Note. Such set off rights shall include the ability by Distributor to submit a purchase order for
Product up to the amount to be repaid on the applicable Note and payment of such purchase order can be set off and applied to repayment of such Note in lieu of making payment to Supplier.
7.10 Subject to 7.9 above and without prejudice to its other rights, Supplier shall be entitled to withhold further deliveries of Products so long as payment of the amounts owed by Distributor is outstanding for more than [***] days after
receiving written notice from Supplier that such payment is past due (other than any payments subject to a good faith dispute).
7.11 Supplier shall separately and fully fund any national discount or promotional campaigns (e.g. discounted goods, Get 3 boxes for the price of 2, etc.).
8. Shipping Method and Delivery Conditions
The Supplier shall, to the extent possible, duly fill the Distributor’s purchase orders. All shipments will be FOB. Distributor will designate the carrier. Distributor will be responsible for taxes and Supplier shall be responsible for insurance
and freight charges.
9. Testing and Notification
The Distributor shall carefully inspect the condition of the Products immediately upon receipt. In the event of any defect, damage or deficiency in the Products, the Distributor shall notify the Supplier in writing within [***] ([***]) days
after receipt of each shipment, with documented images of the defects. Concealed damage or defects are exempt from this requirement. If Distributor fails to notify Supplier of any defect, damage or deficiency within [***] ([***]) days after
receipt, the Products shall be deemed to be in good condition and accepted by Distributor. In any event, the Distributor shall pay the Supplier the full amount for the undamaged Products promptly on the due date in accordance with the terms of this
Agreement. A return policy describing the procedure for returns is included in Appendix C.
10. Complaint Handling and Mandatory Reporting
Complaint handling and mandatory problem reporting will be conducted by the Distributor in accordance with the provisions of Appendix D.
11. Stock Policy and Warehouse Compliance
11.1 Distributor shall maintain a sufficient stock of Products to meet Distributor's requirements for a minimum of [***] months (“Minimum Inventory Level”), which sufficient stock shall enable Distributor to promptly meet all reasonable customer
requests in the Territory.
11.2 In order to permit Supplier to effectively plan capacity for production, Distributor shall provide the forecast and inventory information set forth in Appendix G.
11.3 The Distributor shall maintain stock in such a manner that the Products are stored under the storage conditions specified by the Supplier. The Supplier agrees to maintain and operate its warehousing and distribution facilities in strict
compliance with Good Distribution Practice (GDP) guidelines. This includes ensuring that all storage conditions meet the required standards for temperature, humidity, cleanliness, and security to preserve the integrity of the Products. In the event
of a Product recall, the Supplier shall ensure full traceability of the available stock, enabling prompt and efficient identification and retrieval of affected products. The Supplier also agrees to adhere to good warehousing practices, including
the implementation of First-In-First-Out (FIFO) inventory management to ensure proper rotation of stock. These measures are essential to maintaining the quality, safety, and efficacy of the products throughout the supply chain. The Distributor
shall retain records of the sale of the Products by customer name/address for [***] years, as well as any other relevant information to enable a recall or field safety corrective action to be taken. The Distributor shall make these records
available to the Supplier for traceability verification as needed.
11.4 Products shipped to the Distributor have a minimum shelf life of [***] months. An information sheet on the shelf life of the Products shall be attached to each delivery. The Distributor shall manage its inventory in such a manner as to make
the most efficient use of the shelf life of the Products and efficient picking/packing and invoicing of stock to eliminate errors; provided that Distributor shall have the right, at any time, to return any expiring inventory (inventory with less
than three months remaining shelf life) to Supplier for full replacement at no charge.
11.5 If Supplier reasonably believes, based on the forecasts submitted pursuant to Section 5 or the inventory information provided pursuant to Appendix G, that Distributor's stock on hand may become insufficient to meet anticipated end-user
demand in the Territory, Supplier may so notify Distributor, and the Parties shall discuss in good faith whether Distributor elects to accelerate the timing of its orders within the levels permitted by Section 11.1. Any such acceleration shall be
at Distributor's sole election, shall be based on Distributor's own assessment of anticipated end-user demand, and shall be reflected in purchase orders placed by Distributor in the ordinary course pursuant to Section 6. Product so ordered shall be
sold on the same terms as Product ordered in the ordinary course, and Supplier shall not offer, and Distributor shall not receive, any discount, rebate, credit, extended payment term, expanded right of return or exchange, or other consideration or
incentive in respect of such Product that would not otherwise be available under this Agreement. Supplier's ability to supply accelerated orders shall be subject to its available finished goods inventory and production capacity, it being understood
that Supplier may decline to accelerate to the extent doing so would impair its ability to supply Distributor's ongoing requirements on a consistent and uninterrupted basis.
12. Warranty; Indemnity
12.1 Supplier warrants that its Products will conform to Supplier’s specifications as set forth in Appendix A and will be fit for registered use, and in no event, except as set forth in this Agreement, shall Supplier’s obligation exceed the
obligation to replace a defective Product, which warranty is expressly in lieu of all other warranties, express or implied.
The Distributor shall not grant any other warranties to the DSO Customers other than those provided by Supplier.
12.2 Continuing Guaranty. The parties are subject to the terms of the Continuing Guaranty and Indemnification set forth on Appendix I (the “CG&I”), which CG&I shall survive termination or
expiration of this Agreement. In the event of a conflict between the terms and conditions set forth in this Agreement and the terms and conditions set forth in the CG&I, the terms and conditions set forth in the CG&I shall control. Supplier
agrees that Distributor shall be permitted to pass through to its customer all product warranties, indemnities and remedies provided to Distributor by Supplier, including without limitation those set forth herein and in the CG&I. For the
avoidance of doubt, and without prejudice to any of Distributor’s rights under the CG&I, Supplier and Supplier Parent shall indemnify, defend and hold Distributor harmless for and against any and all liabilities, losses, damages (including
actual, punitive and exemplary damages), claims, costs and expenses, interest, awards, judgments and penalties (including attorneys’ and consultants’ fees and expenses) suffered or incurred by Distributor or arising or resulting from any breach of
the representation and warranty set forth in Section 2.2.
12.3 Distributor shall indemnify, defend and hold Supplier harmless for and against any and all liabilities, losses, damages (including, solely with respect to third party claims, actual, punitive and exemplary damages), claims, costs and
expenses, interest, awards, judgments and penalties (including attorneys’ and consultants’ fees and expenses) suffered or incurred by Supplier or arising or resulting from any (i) breach by Distributor of any obligation to Supplier under this
Agreement or any inaccuracy of any written representation made by Distributor to Supplier under this Agreement; or (ii) negligent or willful action or omission of Distributor or any of its agents, employees, representatives, successors or assigns
in connection with the sale, distribution, storage or dispensing of the Products.
12.4 Anti-Bribery Compliance. Each party shall comply fully with the requirements of any applicable laws, regulations, and administrative requirements prohibiting bribery and corruption (“Anti-Corruption
Laws”). Each party shall refrain from taking any action which would cause the other party to be in violation of any law of any jurisdiction. No principal of either Party has been, is, or will become during the Term (i) an official or employee of a
governmental entity or political party, or (ii) a candidate for political office. Neither party shall directly or indirectly pay, offer, promise, give, or authorize to pay, offer, or give money or anything of value to any employee or official of a
government or department thereof, political party or candidate for political office, to any employees or officials of public international organizations, or to any employees of enterprises or companies owned or controlled by a government, or to any
other person while being aware of or having a belief that such money or item of value will be passed on to one of the above, to influence any act or decision by such person or by any governmental body for the purpose of obtaining, retaining or
directing business to Supplier or Distributor or to otherwise obtain an improper advantage for Supplier or Distributor. Neither party will undertake any action that may cause itself or the other party to be in violation of the Anti-Corruption Laws.
Each party represents and certifies that it has not been convicted of or pleaded guilty to a criminal offense, including one involving fraud, corruption, or moral turpitude, that it is not now, to the best of its knowledge, the subject of any
government investigation for such offenses, and that it is not now listed by any government agency as debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs. Both Parties agree to maintain all
books and records pertaining to the business of that Party for a period of [***] months following the termination of this Agreement.
12.5 Compliance with Law. Each party agrees that it and its directors, officers, employees and agents shall comply with all applicable laws, regulations, ordinances, decisions, and other assurances having
the effect of law in the Territory regarding the relationships and transactions contemplated by this Agreement, including the importation, storage, warehousing, advertising, marketing and other aspects of selling and distributing the Products.
Further, Supplier shall, as soon as possible following its notice thereof, advise Distributor of any change in manufacturing, sale, packaging, labeling or other legal requirements with respect to the sale and distribution of the Products in the
Territory.
12.6 Supplier Code of Conduct. Supplier agrees to adhere to and comply with the principles, terms and conditions specified in the Henry Schein Global Supplier Code of Conduct attached hereto as Appendix
H.
12.7 Access. Each Party agrees to make its facilities and records (to the extent related to its performance of this Agreement) available for inspection by the other Party (or its duly appointed agents or
representatives) during regular business hours upon reasonable prior written notice. Notwithstanding the foregoing, if either Supplier or Distributor counsel believes that such records contain or permit the disclosure of any competitively sensitive
information, Supplier and Distributor’s counsel will work to establish an appropriate clean team to review such records.
13. Status and Capacity of the Distributor
13.1 The Distributor shall at all times act as an independent contractor. Nothing in this Agreement shall be construed to authorize Distributor to bind Supplier, to act as its agent or employee, to hold Distributor out as a legal representative
of Supplier, or to act as a co-owner or joint venture partner of any kind. The Distributor shall distribute the Products for its own account and in its own name. Distributor shall not appoint any third party sub-agent or sub-distributor or assign
any part of the Territory to any other person without the prior written consent of Supplier.
13.2 The Distributor represents and warrants that (i) it has adequate facilities, equipment and personnel to promote the sale of the Products and to perform its obligations under this Agreement; (ii) it is validly incorporated and/or registered
under the laws of the jurisdiction in which it is located; and (iii) it has all legal authority and capacity necessary to carry on the business of distribution and to enter into and perform this Agreement.
13.3 Whenever the Distributor describes its relationship with the Supplier, it must make clear that it is a distributor and not an agent or representative or any other person authorized to enter into contracts or obligations binding on the
Supplier.
13.4 Neither party shall originate any publicity, press releases or other public announcement relating to any relationship between the parties, this Agreement or the performance hereof without the other party’s prior written consent; provided,
however, that either party may, without such consent, make any press release or other public announcement as required by law.
14. Resale
14.1 Distributor hereby represents and warrants that if any DSO Customer or other customer of Distributor receives any discount, rebate or any other price reduction as a result of purchases under this Agreement (each, a “Discount”), Distributor
shall provide such Discounts to customers in compliance with all applicable laws, including, but not limited to the discount safe harbor regulation at 42 C.F.R. § 1001.952(h). Distributor shall fully and accurately report such Discounts to the
extent required by any federal or state health care program, if applicable and will provide any relevant information in connection with the Discount upon Supplier’s request.
14.2 The Distributor shall independently establish its resale prices and terms for the Products in the Territory. Upon request by the Distributor, the Supplier shall provide the Distributor with the Supplier’s retail pricing policy for guidance.
15. Product Documentation and Supplier Support
15.1 Supplier shall provide Product assistance to Distributor in the form of safety data sheets, workflow leaflets, manuals, catalogs and other written instructions so that Distributor may sell the Product. The Distributor shall at all times
procure from the Supplier the Products listed in Appendix A for the purpose of offering them for resale in the Territory. Distributor shall use commercially reasonable efforts to promote and develop sales of the Products in the Territory.
15.2 Supplier shall maintain a sales support team and shall use commercially reasonable efforts to train offices virtually and/or in person, as required by the DSO, within [***] days of onboarding date. Supplier will provide training for
Distributor representatives, including product knowledge, clinical use, and ongoing certifications. Supplier may, at its sole discretion and upon prior written agreement with Distributor, arrange for appropriate sales training courses in the
Territory or by videoconference on the sale of the Products for Distributor’s personnel. The Supplier agrees to provide Distributor with Supplier clinical training courses in an amount per year to be mutually agreed upon by the Parties.
15.3 Supplier will maintain at least its existing headcount for the field sales team as at November 29, 2025 to promote and support Supplier’s products.
15.4 Distributor shall adhere to all of the obligations, including with respect to compliance with laws regarding its sales team. Distributor maintains and will maintain a comprehensive and robust compliance program, including appropriate
training for Distributor’s sales force.
16. Communication and Branding
16.1 The Supplier provides the Distributor with the data for a comprehensive set of communication tools, e.g. product brochures, advertisements.
16.2 All external medical and scientific communication content (e.g. brochures, leaflets, flyers, CDs, DVDs, advertisements, websites, mailings, gadgets, give-aways, publications, press releases, media reports, newsletters, etc.) concerning the
Supplier or its Products must be based on the documentation/information received from the Supplier. In case of doubt, the Supplier must be consulted and approve language.
16.3 The Distributor agrees to fully comply with the rules for the use of the Supplier’s logos and the Supplier’s product logos as set forth on Appendix J. All image and copyright rights must be respected and shall remain the sole property of
Supplier.
17. Insurance
The Distributor shall obtain product and vendor liability insurance, commercial general liability insurance, umbrella or excess liability insurance and workers’ compensation insurance with adequate coverage and in accordance with the rules and
regulations set forth in the laws of the Territory. The Distributor shall name the Supplier as co-insured and provide the Supplier with all relevant documentation. Supplier may request, and Distributor shall promptly provide, a certificate of
insurance evidencing such coverage. The Supplier will obtain insurance as set forth in the CG&I.
18. Disclaimers
EXCEPT AS SET FORTH IN THE CG&I, OR IN THE CASE OF FRAUD OR WILLFUL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS
ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE. THESE LIMITATIONS SHALL
APPLY TO ALL CAUSES OF ACTION IN THE AGGREGATE, INCLUDING WITHOUT LIMITATION BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE, STRICT LIABILITY, MISREPRESENTATION AND OTHER TORTS.
19. Intellectual Property Rights
19.1 The Distributor sells the Products in the packaging and presentation specified by the Supplier and under the trademarks chosen and owned by the Supplier.
19.2 Trademarks are registered exclusively by Supplier at its own expense and by legal counsel chosen by Supplier.
19.3 All rights in the trademarks, designs, patents, copyrights or other Intellectual Property rights, including of the Products or the Supplier-specific know-how are and shall remain the exclusive property of the Supplier. By using them, the
Distributor does not acquire any ownership right, goodwill or other interest in such trademarks, designs, patents, copyrights or other intellectual property rights.
The Distributor shall promptly notify the Supplier of any actual or potential infringement of such Intellectual Property of which it becomes aware. Any use, exploitation or registration of the Supplier’s Intellectual Property in the name of the
Supplier or in the name of any person under the direct or indirect control of the Supplier, in its original form or in a manner confusingly similar to or infringing the Supplier’s Intellectual Property, without the express written permission of the
Supplier, is prohibited.
19.4 For purposes of this Agreement, “Intellectual Property” means any and all: (a) copyrights, trademarks, trade names, domain names, goodwill associated with trademarks and trade names, designs and patents, regardless of where registered and
including, but not limited to, with respect to the Products; (b) rights relating to innovations, know-how, trade secrets and Confidential Information (technical and non-technical); (c) moral rights, mask work rights, author’s rights and rights of
publicity; and (d) other industrial, proprietary and intellectual property-related rights anywhere in the world that exist as of the date of this Agreement or hereafter come into existence, and all renewals and extensions of the foregoing,
regardless of whether or not such rights have been registered with the appropriate authorities in such jurisdictions in accordance with applicable laws.
20. Registrations and Standards
20.1 The Supplier is obliged to apply for and maintain all licenses, permits and registrations required by the authorities for the sale of the Products in accordance with the laws of the Territory and for the shipment of the Products in the
Territory. The Supplier is the owner of the certificate of product registration.
20.2 The Distributor is not authorized to modify the Products or the packaging of the Products in any way. Additional labels may be applied to the packaging only with the approval of the Supplier. If Products must be relabeled to comply with
local regulations, such relabeling shall be the responsibility of the Distributor but with notice to and approval of the Supplier.
20.3 The Distributor shall comply with all legal and quality standards applicable to a Distributor of the Products in the Territory, as set forth in Appendix F.
20.4 Each party is obliged to promptly inform the other party upon it becoming aware of any changes in the licenses, permits and registrations required by the authorities for the Distributor’s sale of the Products, as well as of any changes in
the Territory in relation to the legal and qualitative standards applicable to Distributor’s distribution of the Products.
21. Confidentiality Obligation
21.1 Each of the Parties agrees to keep in strict confidence any trade or business secrets or other confidential or proprietary information provided, disclosed or otherwise made known by the other Party in oral, written, graphic, electronic or
other form, whether tangible or intangible, in connection with this Agreement (“Confidential Information”), in strict confidence and shall not be disclosed to any third party without the prior written consent of the other Party, including, but not
limited to, all inventions, formulas, technical information, materials, discoveries, designs and drawings, research data, manufacturing processes and techniques, concepts, test results, know-how, financial information, scientific, manufacturing,
marketing and business plans, market research data, sales, suppliers and customers. The receiving party may use confidential information of the other party only for the purpose of performing this Agreement.
21.2 Confidential Information does not include information that:
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is generally known or accessible to the public or become known at a later date without breach of this Agreement;
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(b) |
is known to the receiving party at the time of disclosure;
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(c) |
was lawfully received by the receiving party from a third party without any known obligation of confidentiality;
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(d) |
independently developed by the receiving party, provided that the person(s) developing it did not use or reference such Confidential Information; or
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(e) |
must be disclosed by law, regulations or the rules of any national stock exchange.
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21.3 The obligations set forth in this Section 21 shall survive the expiration or termination of this Agreement for a period of [***] years.
22. Duration and Termination of the Agreement
22.1 This Third Amended and Restated Agreement shall enter into force on September 29, 2026 and shall remain in full force and effect until December 31, 2029 (the “Initial Term”) and will automatically renew for one-year periods (each, a
“Renewal Term” and collectively with the Initial Term, the “Term”) unless terminated in writing by either Party upon [***] ([***]) months’ notice prior to the expiration of the Initial Term or any Renewal Term, whichever is applicable. For the
avoidance of doubt, any Exclusivity (other than any Exclusivity Tail) terminates upon termination or expiration of the Agreement.
22.2 If either Party to this Agreement first defaults with respect to any material term of this Agreement or first breaches any of the material covenants contained in this Agreement and fails to cure such default or breach within [***] ([***])
business days after receipt of written notice of the existence of such default or breach, or if either Party materially defaults or breaches this Agreement for the second time, the other Party may, in its sole discretion and by written notice,
immediately terminate this Agreement and the rights granted hereunder.
22.3 In addition to the termination option set forth in Section 22.2 above, either party shall have the right to terminate the Agreement with immediate effect by written notice to the other party, if
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either party (i) becomes insolvent, (ii) dissolves or terminates its existence, (iii) files a bankruptcy proceeding or (iv) has a bankruptcy proceeding commenced against it, which proceeding has been neither stayed nor dismissed within
60 days from its commencement; or
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either party is liquidated and the surviving entity is an entity other than the current party to the Agreement.
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Except in the event of termination by Supplier due to an uncured breach or default by Distributor in performance of the terms of this Agreement, Supplier shall honor all orders for Product that Distributor placed prior to the effective date of
termination. Termination shall not affect the rights or obligations of either party accrued as of the effective date of such termination or that may arise subsequently with respect to transactions initiated or completed prior to the effective date
of such termination.
In the event of termination by Distributor due to an uncured breach or default by Supplier in performance of the terms of this Agreement, Supplier agrees to purchase all of Distributor’s remaining inventory upon termination for a full refund.
22.4 Unless Supplier purchases all of Distributor’s remaining inventory at the time of termination, Distributor shall have the right to continue to sell its inventory in the Territory until the earlier of (a) [***] months from the time of
termination and (b) such inventory is depleted (“Inventory Tail”). Upon expiration of this Agreement and any Inventory Tail (if applicable), or in the event of termination of this Agreement for any reason and the expiration of any Inventory Tail
(if applicable), whether in its entirety or with respect to a particular Product, Distributor shall, as the case may be
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Immediately cease and desist from selling, advertising, offering, shipping and transporting the Products;
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promptly return to Supplier the sales promotion and sales training materials (current and non-obsolete materials only) in Supplier’s possession at ex-factory prices at that time;
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promptly provide Supplier with a reasonable and final accounting of all transactions under this Agreement, if it has not already provided an accounting; and
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immediately refrain from using any trademarks, designs, patents or other Intellectual Property rights of Supplier and any know-how specific to Supplier.
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Notwithstanding the foregoing, nothing herein, including the above provisions, shall in any way be construed as a limitation on Distributor’s ability to sell Product in the event there is a need to exercise by Distributor any credit or
redemption of its Prepayment and selling any and all of the inventory subject thereto, or to exercise any foreclosure on the inventory or exercise of Distributor’s rights under the Security Agreements or other Transaction Documents.
23. General
23.1 This Agreement may not be assigned by either party without prior written consent of the other party; provided that either party may assign this Agreement to an affiliate of such party without consent. Notwithstanding the foregoing, in the
event of a Change of Control (defined below) of Supplier, this Agreement shall remain in full force and effect and the terms and obligations of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective
successors and permitted assigns, and shall be enforceable against any successor in interest to Supplier or Supplier Parent as if such successor were an original party to this agreement. “Change of Control” means (a) the acquisition of more than
50% of the Supplier Parent’s or Supplier’s outstanding shares by any person in any transaction or series of related transactions; (b) a merger, spin-off or other type of restructuring in which the holders of the voting securities of the Supplier or
Supplier Parent outstanding immediately prior to such transaction retain less than the majority of the total voting power represented by the voting securities of the Supplier Parent, Supplier or such surviving entity outstanding immediately after
such transaction; (c) a sale, lease, transfer, exclusive license or other conveyance of all or substantially all of the assets of the Parent or the Supplier in an arms’ length transaction (other than to a wholly-owned subsidiary of the Supplier
Parent); or (d) Supplier ceases to be a wholly-owned subsidiary of the Supplier Parent. Change of Control should include any IPO of Supplier Parent or Supplier.
23.2 Nothing in this Agreement shall prohibit Supplier from withdrawing the Products from the market or prevent Supplier from modifying the specifications of the Products as Supplier may deem appropriate in due course. However, Supplier shall
notify Distributor in writing at least [***] days prior to the date that Supplier intends to discontinue the distribution or sale of any Products or any version of the Products. Notwithstanding its receipt of such notice, Distributor may continue
to sell such discontinued Products until its inventory is depleted. Distributor may, at its option, within [***] days after its receipt of such notice, return all discontinued Products remaining in its inventory for full refund from Supplier.
Supplier shall pay all shipping costs associated with such return.
23.3 Nothing in this Agreement shall be construed to derogate from the statutory liability for damages suffered by third parties as a result of defective Products distributed under this Agreement.
23.4 Distributor shall promptly notify Supplier in writing if it becomes aware of any adverse reaction or possible claim or demand caused or alleged to be caused by the Products. Supplier is responsible to complete an adverse reaction/incident
investigation and to provide the Distributor a written response within two weeks of receipt of the initial complaint. Each Party shall notify the other Party immediately if the other Party determines that
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there is a Product recall;
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there is a likely risk of an incident that in such party’s reasonable opinion would materially damage the reputation of the Supplier or the Distributor; or
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there is a legally binding order from a regulatory authority or a court of competent jurisdiction that the Product must be withdrawn from sale.
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23.5 If a recall is ordered under Section 23.4(c) above, the Distributor shall conduct the recall in accordance with the instructions of the Supplier to the extent permitted by applicable law. All other recalls or withdrawals of Products shall
be at the sole discretion of Supplier (unless recall relates to Distributor’s handling of the Product, in which case Distributor may be permitted to initiate a recall after notifying and consulting with Supplier or as required by law). Each Party
shall cooperate fully with the other party in the event of a recall or proposed recall or withdrawal and shall provide such assistance in connection with the recall, proposed recall or withdrawal as the other Party may reasonably request.
Distributor shall carefully maintain books and records to ensure traceability of Products in the event of a Product recall. In the event of a recall, no press releases, interviews or statements shall be made to third parties without the prior
written consent of the Supplier unless required by law. The costs of a recall shall be borne by the Supplier. The Distributor shall use commercially reasonable efforts to support the Supplier in minimizing the financial damage.
23.6 The Supplier shall be solely responsible for responding to questions and complaints received from the Distributor’s customers (unless questions and complaints relate to Distributor’s handling of the Product). Questions or complaints
received by Distributor from Distributor’s customers shall be promptly forwarded to Supplier at [***], with a copy to Supplier’s current business contact within two business days of receipt. Each of Distributor and Supplier is required to cooperate
with each other to a reasonable extent to help determine the cause of and resolve customer questions and complaints. This includes providing product information, including any customer statements, available packaging, medical information, or
medical diagnoses, so that Supplier can respond to questions or complaints related to the product or submit appropriate reports to the appropriate regulatory authorities.
24. Force Majeure
Notwithstanding anything contained herein to the contrary, neither Party shall be liable to the other for delay in any performance or failure to render any performance under this Agreement or any Purchase Order when such delay or failure (a) is
beyond the reasonable control of, and without intentional negligence, fault, wrongdoing or bad faith of, and (b) by the exercise of reasonable diligence could not be prevented by the Party asserting the claim of Force Majeure. A “Force Majeure”
will include any acts of God, strikes, terrorist acts, lockouts or other labor disputes or industrial disturbances, civil disturbances, shortage of raw materials or energy, acts, directives or binding orders of any court or governmental authority
or person purporting to act therefor and such orders or regulations (regardless of the validity of such order or regulation) of governmental bodies or agencies asserting jurisdiction as would inhibit or prohibit performance required by this
Agreement.
In the event of a Force Majeure with respect to a Party, such Party will be correspondingly relieved of its obligations to perform pursuant to this Agreement as long as such Force Majeure will be continuing if such event of Force Majeure makes
performance of such Party’s obligations illegal or impossible; provided, however, that the Party claiming the Force Majeure must (i) provide notice to the other Party as soon as the claiming Party is aware of facts upon which such claim is based,
(ii) use commercially reasonable efforts to mitigate the effect of such event of Force Majeure and (iii) recommence the performance of its obligations as soon as reasonably possible. If a condition of Force Majeure continues for a period of time
such that this Agreement becomes commercially impracticable, each Party will have the right to terminate this Agreement upon written notice to the other Party.
Notwithstanding the foregoing, in no event, including during any Force Majeure, shall Supplier or Supplier Parent be relieved of its obligation to refund, or timely allow Distributor to redeem Product against, any outstanding portion of the
Prepayment.
25. Taxes
The amount of all applicable taxes will be added to the price and borne by the Distributor. Alternatively, the Distributor may provide the Supplier with an exemption certificate acceptable to the tax authorities.
26. Other
26.1 This Agreement may be modified or amended only by a writing duly signed by both Parties. This Agreement, the Notes, the Security Agreements, the Parent Guarantee Agreements, including the exhibits, addenda, schedules and any other documents
referred to in this Agreement that are incorporated and made part of this Agreement or the Notes, Parent Guarantee Agreements or the Security Agreements, constitutes the complete terms agreed by the Parties in relation to the sale of Products by
Supplier to Distributor and the distribution and resale of the Products by Distributor, and supersedes any and all prior agreements, understandings or arrangements between them, whether oral or in writing, in relation to such matters.
26.2 This Agreement shall be governed in all respects by the substantive laws of Delaware, excluding its conflict of law rules.
26.3 The Parties expressly agree that all disputes arising out of or in connection with this Agreement shall be submitted to the exclusive jurisdiction of the courts of Delaware.
26.4 This Agreement may be executed in any number of counterparts, each of which is deemed an original but all of which constitute the same instrument. This Agreement may be executed by the exchange of certified electronic signatures or copies
delivered by electronic mail in Adobe Portable Document Format or similar format, and any signature transmitted by such means for the purpose of executing this Agreement is deemed an original signature for purposes of this Agreement.
26.5 Except as otherwise provided, all notices given under this Agreement shall be in writing and shall be deemed to have been duly given upon receipt if delivered by hand or three days after mailing by certified or registered mail, and one day
after sending by overnight courier, to the parties’ respective address indicated below or such other address as a party specifies in writing to the other party. All notices given to Distributor under this Agreement shall be sent via email to [***],
with a hard copy to Henry Schein, Inc., [***]. All notices given to Supplier shall be sent via email to [***] and [***], with a hard copy to vVARDIS Inc., [***].
26.6 The Parties acknowledge that the Notes, Note Purchase Agreements, Security Agreements, and Guarantee Agreements have been amended, to the extent applicable, to (i) extend the Maturity Date of the Notes to June 30, 2027, (ii) bring down the
representations and warranties contained in such Transaction Documents, (iii) include an additional representation substantially the same as the one set forth in Section 2.2 of this Agreement, and (iv) make such other amendments to the Transaction
Documents (including any UCC filings) as were required to memorialize such amendments, and that no further action is required of either Party in respect of the foregoing.
[Remainder of Page Left Intentionally Blank]
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vVARDIS INC.
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By:
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/s/ Thomas Rondot
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Name:
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Thomas Rondot
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Title:
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CFO
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By:
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/s/ Keith Koford |
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Name:
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Keith Koford
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Title:
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General Counsel
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vVARDIS HOLDING AG
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By:
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/s/ Haleh Abivardi Brönner |
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Name:
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Haleh Abivardi Brönner
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Title:
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Co-CEO
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By:
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/s/ Golnar Abivardi Signer |
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Name:
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Golnar Abivardi Signer
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Title:
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Co-CEO
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HENRY SCHEIN, INC.
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By:
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/s/ Steven Kizy
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Name:
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Steven Kizy
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Title:
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VP Business Development
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Appendix A — Products
For the purpose of Section 3.6 and the calculation of the Select DSO Chargeback, the Distributor Wholesale Price for Products purchased prior to the Second Amended and Restated Effective Date is $[***] per Box of Curodont Repair Fluoride Plus
and $[***] per Box of Curodont Protect US. For Product purchased on or after the Second Amended and Restated Effective Date, the product and pricing table set forth below shall apply.
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Manufacturer Item Number
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Name
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Unit and Quantity
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Distributor Wholesale Price
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Margin
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MOQ
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Weight [g]
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L x W [cm]
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FDA Regulations Number
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FDA Product Code (OTC) (NDC)
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[***]
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CURODONT REPAIR FLUORIDE PLUS
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Box containing [***] applicators per box
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$[***]
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[***]%
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[***]
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[***]
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[***] x [***]
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[***]
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[***]
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[***]
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CURODONT PROTECT US
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Box containing [***] tubes per box
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$[***]
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[***]%
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[***]
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[***]
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[***] x [***]
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[***]
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[***]
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Appendix B — Contact Methods for Purchasing
Contact information:
vVARDIS Inc.
[***]
Customer Service Contact Information:
[***]
Appendix C — Return Policy for Damaged, Defective and Incorrect Products
Reasons for returns eligible for credit/replacement by Supplier.
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Reasons
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Type of compensation
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Goods that are defective or damaged upon receipt by the Distributor and for which the Supplier is responsible. (Example: The Products show factory damage upon receipt of delivery by the Distributor).
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The goods will be replaced if the claim is submitted in writing within [***] ([***]) working days of receipt of the goods and accepted by Supplier.
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Wrong Products
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Complaints related to the delivery of incorrect Products will only be accepted within [***] ([***]) working days after receipt of the goods. Any claim must be substantiated, stating the item number, quantity, Distributor’s order number
and Supplier’s invoice number.
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Recalls/Non-Compliant
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Product that is subject to a recall or is no longer in compliance with or is no longer able to be sold by Distributor under the applicable laws of the Territories in which it is contemplated that the Products will be sold can be returned
to Supplier for a full refund.
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Expiring Products (any inventory with less than three months remaining shelf life)
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Full replacement with no charge to Distributor
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Customer Dissatisfaction
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Any Product returned by customer that cannot be resold can be returned to Supplier for full replacement
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Product Discontinuance/Termination of Agreement
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All remaining inventory can be returned for full refund in accordance with terms of the Agreement
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Bankruptcy of Distributor
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No compensation.
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Appendix D — Complaint Handling and Mandatory Problem Reporting
Definitions:
A “complaint” is any issue related to the identity, quality, durability, reliability, safety, effectiveness, or performance characteristics of a product, including any customer or consumer complaint once it is released for commercial
distribution.
A field safety corrective action is an action taken by Supplier to reduce the risk of serious health deterioration associated with the use of a product already on the market.
Distributor shall transmit to Supplier by email within two business days of receipt all complaints received by Distributor with respect to the Products that are the subject of this Agreement.
The complaint report must contain the following information:
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a) |
Name and address of the customer
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b) |
Batch number and product type
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c) |
Description of the problem
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d) |
Type of application (if applicable)
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e) |
Appearance/patient symptoms, duration, outcome (if applicable)
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f) |
Concomitant medication (if applicable)
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g) |
Product sample for analysis (in case of quality complaint)
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The complaint should be reported by e-mail to [***].
Except to the extent Distributor reasonably believes notification by Distributor is required due to its handling of the Product, Supplier shall be responsible for making the final determination as to whether or not an event should be reported to
the authorities in the Territory and whether other action is required (i.e., a field safety corrective action or a product recall). Except to the extent Distributor reasonably believes notification by Distributor is required due to its handling of
the Product, Supplier shall make all contacts with the appropriate regulatory authorities in the Territory of this Agreement and shall be responsible for coordinating all necessary actions related to any such recall or field safety corrective
action. In such cases as Distributor reasonably believes notification by Distributor is required due to its handling of the Product, Distributor will work with Supplier on a coordinated notification (it being understood that Distributor shall be
permitted to take any action that is required by law).
Appendix E — Meeting Governance
The Parties will meet on a quarterly basis (and can be more often as needed), with attendees endeavoring to include (schedules permitting) each [***].
Quarterly Meeting Agenda
[***]
Appendix F — Quality Standards
The Distributor sells the Product in accordance with the following quality standards:
[***]
The Supplier quality personnel may be contacted at [***]
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Responsibilities
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Distributor
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Supplier
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Compliance with [***] and/or other quality criteria as specified in this Agreement.
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X
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X
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Production, packaging and labeling
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Documentation stating that purchase orders consist of product ID, quantity and delivery date
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X
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X
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Documentation and records
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The declaration of conformity is enclosed with each delivery.
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X
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Records must be retained for a period of [***] years from the date of delivery.
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X
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Records must be secured against readability, loss, damage, deletion and falsification. The records must be available within [***].
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X
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After being informed by Supplier, records shall not be disposed of.
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X
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Storage and distribution
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Documentation supporting recommended storage and transportation conditions and reassessment or expiration dates shall be retained and provided upon request.
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X
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Ensuring that all Products delivered match the order.
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X
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X
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Ensuring that a physical inspection is performed upon receipt of the Products.
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X
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Ensure that the Products are stored and shipped in accordance with the storage conditions recommended by Supplier.
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X
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Ensuring that no damage occurs during transportation to the customer. The Distributor is liable for defective Products.
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X
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Ensure full traceability of the Product.
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X
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Change control
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Changes to the Product will be communicated within a reasonable period of time.
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X
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Special cases with deadlines: Major operational disruption, e.g. fire or flood: [***] working days; Change of key persons: [***] working days; Other changes affecting quality: [***] working days
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X
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X
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Non-compliance / complaints
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Distributor
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Supplier
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Has a written procedure for investigating and documenting quality-related complaints. Within a reasonable time after receipt of the complaint, the customer receives a root cause analysis, actions to correct the problem and prevent future
occurrences, and a formal closure.
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X
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X
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The parties shall cooperate in the disclosure of information necessary for the effective handling of complaints.
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X
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X
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Recalls
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In the event of a recall of Products, Supplier shall notify Distributor of the proposed recall without unreasonable delay.
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X
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A written recall procedure must be in place.
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X
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X
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The Parties shall cooperate in sharing information necessary to effectively conduct a recall or recall investigation.
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X
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X
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Supplier shall notify Distributor as soon as possible of any Product recalls that have been or are under investigation and may be related to the quality of the Product.
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X
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Auditing
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The right to conduct “for cause” audits at Distributor’s facilities, systems, and records relating to the handling of the Product at mutually agreed upon times.
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X
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Supplier shall issue a confidential written audit report to Distributor within [***] days, including audit observations.
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X
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The Distributor shall respond to all observations in writing to the Customer’s Quality Assurance Department within 30 days. If the Distributor commits to a corrective action, the written response shall include a description and timeframe
for implementation.
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X
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Distributor shall inform Supplier of critical observations made by other customers or health authorities in their facilities.
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X
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Appendix G — Forecast and Inventory Information
Distributor shall provide, in order to plan capacity for production:
[***]
Appendix H — Henry Schein Global Supplier Code of Conduct
Purpose and Scope
At Henry Schein, we believe acting ethically and responsibly is not only the right thing to do, but also the right thing to do for our business. Henry Schein has developed this Global Supplier Code of Conduct (“Supplier Code”) to clarify our
global expectations in the areas of business integrity, labor practices, employee health and safety and environmental management. This Supplier Code is intended to complement Henry Schein’s Worldwide Business Standards (available under the
Corporate Governance section of our website at www.henryschein.com) and Henry Schein’s other policies and standards referenced therein.
Suppliers, vendors, and other providers of goods and services who do business with Henry Schein entities worldwide (“Suppliers”) are expected to follow this Supplier Code.
Business Conduct Principles
Henry Schein expects its Suppliers to conduct business responsibly, with integrity, honesty and to adhere to our values and the following principles:
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Maintain awareness of, and comply with, all applicable laws and regulations. Suppliers shall maintain awareness of, and comply with, all applicable laws and regulations.
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2. |
Compete fairly for business, without paying bribes, kickbacks or giving anything of value to secure an improper advantage. Henry Schein is committed to conducting business legally and ethically
within the framework of a free enterprise system. Corrupt arrangements with customers, suppliers, government officials or other third parties by Suppliers are strictly prohibited. “Corruption” generally refers to obtaining, or attempting to
obtain, a personal benefit or business advantage (for yourself or third parties) through dishonest or illegal means.
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3. |
Encourage a diverse workforce and provide a workplace free from discrimination, harassment or any other form of abuse. Suppliers shall create a work environment in which employees and business
partners feel valued and respected for their contributions. Harassment, including unwelcome verbal, visual, physical or other conduct of any kind that creates an intimidating, offensive or hostile work environment will not be tolerated.
Suppliers shall not discriminate in employment, including with regard to hiring, compensation, advancement, discipline, termination and retirement, in violation of the laws and regulations, including on the basis of alienage or citizenship,
age, color, creed, disability, gender identity, genetic characteristics, marital status, domestic violence victim status, conviction record, military status, national origin, pregnancy, childbirth- and pregnancy-related medical conditions,
race, religion, sex/gender, sexual orientation, or veteran status.
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Treat employees fairly, including with respect to wages, working hours and benefits. Suppliers shall comply with all applicable laws and regulations and will generally apply sound employee
relations practices. Working hours, wages and benefits will be consistent with laws and industry standards, including those pertaining to minimum wages, overtime, other elements of compensation and legally mandated benefits.
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Maintain and promote fundamental human rights. Henry Schein respects human rights as recognized by the principles as defined in the United Nations Universal Declaration of Human Rights, the
International Covenant on Economic Social and Cultural Rights, and the International Covenant on Civil and Political Rights and the core labor standards set out in the International Labor Organization’s (ILO) Declaration on Fundamental
Principles and Rights at Work. Suppliers shall maintain and promote fundamental human rights. Employment decisions will be based on free choice and may not involve forced or prison labor, physical punishment or threats of violence or other
forms of physical, sexual, psychological or verbal abuse as a method of discipline or control.
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6. |
Prohibit use of child labor. Suppliers shall adhere to the minimum employment age limit defined by applicable laws or regulations, and comply with applicable International Labor Organization
standards. In no instance shall a Supplier permit children to perform work that exposes them to undue physical risks that can harm physical, mental or emotional development or improperly interfere with their schooling needs.
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Respect employees’ right to freedom of association and collective bargaining, consistent with applicable laws and regulations. Consistent with applicable laws and regulations, Suppliers shall
respect employees’ rights to join or refrain from joining associations and worker organizations. Supplier will permit workers to openly communicate and share grievances with management about working conditions and management practices
without fear of reprisal, intimidation or harassment.
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Provide safe and healthy working conditions. Suppliers shall proactively manage health and safety risks to minimize occupational injuries and illnesses. Suppliers must implement management systems
and controls that identify hazards and assess and control risk related to their specific industry. Suppliers shall maintain records of work-related accidents, injuries or sicknesses and corrective actions.
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9. |
Carry out operations with care for the environment and comply with all applicable environmental laws and regulations. When making business decisions, Suppliers are to consider the potential
environmental impact of their activities along with opportunities for conservation of natural resources, recycling, source reduction, and pollution control to ensure cleaner air and water, and to reduce landfill wastes.
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10. |
Conflict Minerals. Suppliers are expected to ensure that products supplied to Henry Schein do not contain metals derived from minerals (or their derivatives originated from) conflict regions that
directly or indirectly finance or benefit armed groups (including from the Democratic Republic of the Congo or an adjoining country).
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11. |
Maintain accurate financial books and business records. Suppliers shall maintain accurate financial books and business records in accordance with all applicable laws and regulations and accepted
accounting practices.
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12. |
Deliver products and services meeting applicable quality and safety standards. Suppliers shall have adequate controls in place to ensure the integrity, quality and safety of their products and
services provided by Supplier to Henry Schein.
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13. |
Support compliance with this Supplier Code by establishing appropriate management processes and cooperating with reasonable assessment processes requested by Henry Schein. Suppliers shall establish
appropriate management processes and maintain records to comply with this Supplier Code. With prior notice, Henry Schein may conduct reasonable audits to verify Supplier’s compliance with this Supplier Code.
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14. |
Prohibit gifts and entertainment to Henry Schein employees. Suppliers are prohibited from providing or offering gifts or entertainment to Henry Schein employees that could inappropriately influence
Henry Schein’s business decisions or gain an unfair advantage.
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15. |
Report suspected violations of this Supplier Code. Suppliers’ employees or agents may report suspected violations of this Supplier Code to the Henry Schein Confidential Compliance Helpline which is
available worldwide, 24 hours a day, 7 days a week at 1-888-422-8997 for United States and Canada or 1-631-843-9404 (reverse the charges) for international calls. All such reports are treated as confidential, where permitted by law, and the
reporter may remain anonymous, where permitted by law. We note that anonymous report or call may be more difficult to investigate.
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Acknowledged and Agreed:
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Print Name of Supplier
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By:
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(Authorized signatory)
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Name:
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Title:
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Appendix I — Executed Continuing Guaranty and Indemnification
[***]
Appendix J — Supplier Product Logos
[***]
Appendix K — Transaction Documents
Note Purchase Agreement dated as of August 19, 2024, among vVARDIS Inc., Henry Schein, Inc. and vVARDIS Holding AG (the “August Note Purchase Agreement”)
Note Purchase Agreement dated as of December 19, 2024, among vVARDIS Inc., Henry Schein, Inc. and vVARDIS Holding AG
Promissory Note dated as of August 19, 2024, between vVARDIS Inc. and Henry Schein, Inc. (the “August Note”)
Promissory Note dated as of December 19, 2024, between vVARDIS Inc. and Henry Schein, Inc. (the “December Note”)
Guarantee dated as of August 19, 2024, between vVARDIS Holding AG and Henry Schein, Inc.
Guarantee dated as of December 19, 2024, between vVARDIS Holding AG and Henry Schein, Inc.
Security Agreement dated as of August 19, 2024, between vVARDIS Holding AG and Henry Schein, Inc.
Security Agreement dated as of December 19, 2024, between vVARDIS Holding AG and Henry Schein, Inc.
Description of Related Agreements
Italy Distribution Agreement, dated as of December 19, 2024, between SSB Operation GmbH, as Supplier, vVARDIS Holding AG as Supplier Parent and Henry Schein, Inc. as Distributor
United Kingdom Distribution Agreement, dated as of December 19, 2024, between SSB Operation GmbH, as Supplier, vVARDIS Holding AG as Supplier Parent and Henry Schein, Inc. as Distributor
For the avoidance of doubt, any references to the Distribution Agreement, dated August 19, 2024 among vVARDIS Holding AG, vVARDIS Inc. and Henry Schein, Inc. contained in the Note Purchase Agreements, the Promissory Notes, the Guarantees or
Security Agreements shall be considered to refer to this Third Amended and Restated Distribution Agreement, as the same may be further amended, supplemented or otherwise modified from time to time.