Document:

EX-10.9

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such
excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. 
 Exhibit 10.9

  
  

AMENDED AND RESTATED SUPPLY AGREEMENT - US 

BETWEEN 
 BIOVENTUS LLC

 AND 
 Q-MED AB 
 December 9, 2016 

 
  

 AMENDED AND RESTATED SUPPLY AGREEMENT - US

 This Amended and Restated Supply Agreement – US (together with all schedules and exhibits attached hereto, this “Agreement”)
is entered into as of December 9, 2016 (the “Amendment Effective Date”), between Bioventus LLC, a limited liability company organized under the laws of Delaware (“Bioventus”), Q-Med AB, a limited liability company organized under the laws of the Kingdom of Sweden with corporate registration number 556258-6882 (“Q-Med”) and Nestlé Skin Health S.A., a corporation organized under the laws of Switzerland, as guarantor of Q-Med’s obligations hereunder
(“Guarantor”). Each of (i) Q-Med and Guarantor, on the one hand, and (ii) Bioventus, on the other hand, shall be referred to herein as a “Party” and
collectively as the “Parties.” This Agreement shall amend, supersede and replace the Current US Supply License Agreement (as defined below). 

BACKGROUND: 
 On June 27, 2006 (the
“Initial Effective Date”), Smith & Nephew, Inc. (“S&N”) and Q-Med entered into (i) that certain Supply Agreement (the “Original
Supply Agreement”) and (ii) that certain License Agreement (the “Original License Agreement”) pursuant to which S&N was granted rights to sell certain products containing polymerized and cross-linked hyaluronic acid, including Q-Med’s DUROLANE® product and
Q-Med agreed to supply S&N and its Affiliates and permitted Sublicensees (each as defined herein) with such products. 

Pursuant to a Consent and Waiver Letter, dated December 31, 2011, from S&N to Q-Med (the “Consent
Letter”), (i) certain terms of the Original Supply Agreement were amended (as so amended, the “Amended Supply Agreement”), (ii) certain terms of the Original License Agreement were amended (as so
amended, the “Amended License Agreement”), and (iii) Q-Med consented to the assignment by S&N of its rights and obligations under the Amended License Agreement and the
Amended Supply Agreement to Bioventus Limited, a limited liability company organized under the laws of Jersey (“Bioventus Limited”). Bioventus Limited assigned its rights under the Amended Supply Agreement with respect to
Territory to Bioventus Coöperatief U.A., a limited liability company organized under the laws of the Netherlands (“Coöperatief”), to cover matters related to the worldwide territory excluding the United
States. 
 Pursuant to an Amended and Restated Supply Agreement – Worldwide Excluding the US (ROW), dated December 31, 2013, Q-Med, Galderma S.A. (“GSA”) and Coöperatief further amended the Amended Supply Agreement to cover matters related to the [***] territory excluding the United States (the
“Current ROW Supply Agreement”) and simultaneously entered into an amendment to the Amended Supply Agreement (the “Current [***] Supply Agreement”) and the Amended License Agreement (the
“Current US License Agreement”), in each case to cover matters related the United States, while pursuant to an Amended and Restated License Agreement – Worldwide Excluding the US (ROW), dated December 31, 2013, Q-Med, GSA and Bioventus Limited further amended the Amended License Agreement to cover matters related to the worldwide territory excluding the United States (the “Current ROW License Agreement”).

 Pursuant to a Nasha Trademark License dated November 16, 2015 (“Current Nasha License Agreement”), Q-Med and GSA licensed the NASHA trademark to Bioventus Limited to cover matters related to the worldwide territory excluding the United States. 

 Q-Med and Bioventus desire to further amend and restate the Current
US Supply Agreement by entering into this Agreement and a Quality Agreement, and simultaneously entering into an amendment to the Current US License Agreement (“New US License Agreement”), to cover matters related the
United States and a license agreement similar to the Current Nasha Trademark License to cover matters in the United States (“New Nasha Amended License Agreement”). 

The Parties hereby agree as follows: 
 ARTICLE
1. DEFINITIONS 
  

	1.1	 Definitions. For the purposes of this Agreement, unless otherwise defined in this Agreement, the
following words and phrases shall have the following meanings and all other capitalized and undefined terms shall have the meanings set forth in the New US License Agreement: 

“AAA” has the meaning set forth in Section 9.4. 

“Agreement” has the meaning set forth in the Preamble. 

“Amendment Effective Date” has the meaning set forth in the Preamble. 

“Bioventus” has the meaning set forth in the Preamble. 

“Bioventus Discretionary Changes” has the meaning set forth in Section 2.6(c). 

“Breaching Party” has the meaning set forth in Section 6.3. 

“Business Day” means any day between and including Monday through Friday; provided, that, with respect to any payment to be
made or forecast or notice to be provided hereunder by a Party, if the date on which such payment, forecast or notice is due falls on a national bank holiday in the country in which the principal place of business of either Party (or, in the case of
a payment, only the paying Party) is located, such payment or notice shall be due on the next day on which banks in such country(ies) are open for business and such forecast shall be due on the preceding day on which banks in such country(ies) are
open for business. 
 “Capacity Shortage” has the meaning set forth in Section 2.7. 

“Consent Letter” has the meaning set forth in the Background. 

“Current Nasha License Agreement” has the meaning set forth in the Background. 

“Current US License Agreement” has the meaning set forth in the Background. 

“Current US Supply Agreement” has the meaning set forth in the Background. 

“Delinquent Payment” has the meaning set forth in Section 3.3(b). 

“FDCA” means the U.S. Federal Food, Drug and Cosmetic Act. 

  
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 “Firm Order” means a written, irrevocable purchase order for the Licensed Product
that shall include (a) the quantity of such Licensed Product ordered; and (b) a delivery schedule specifying the monthly delivery date for Licensed Product ordered and the shipment destination(s). 

“Firm Order Maximum Quantities” has the meaning set forth in Section 2.2(a). 

“Forecast” has the meaning set forth in Section 2.2(a). 

“GMP” means Good Manufacturing Practices applicable to the Licensed Product that are promulgated or otherwise established by any
Regulatory Authority, including those set forth in the FDA’s Quality System Regulations in 21 C.F.R. Part 820, and the European Council Directive concerning Medical Devices, 93/42/EEC. 

“Guarantor” has the meaning set forth in the Preamble. 

“Labeling” means all labels and other written, printed or graphic material upon any Licensed Product or any of its containers or
wrappers accompanying such Licensed Product, including package leaflets, instructions for use and package inserts. 
 “Latent Defect”
has the meaning set forth in Section 4.3. 
 “Laws and Rules” has the meaning set forth in Section 2.6(a). 

“Legally Required Changes” has the meaning set forth in Section 2.6(a). 

“Licensed Product Claims” has the meaning set forth in Section 4.6(a). 

“Major Supply Default” has the meaning set forth in Section 6.2. 

“Manufacture” and “Manufacturing” and other forms of such words means the manufacturing, processing, handling,
packaging and quality control testing (including in-process, release and stability testing) of Licensed Product. 

“Manufacturing License Actions” has the meaning set forth in Section 6.2. 

“Manufacturing Licensee” has the meaning set forth in Section 6.2. 

“Market Launch” means with regard to the Licensed Product, the date following Regulatory Approval (if applicable) on which the
Licensed Product is first commercially sold by Bioventus in the United States to a Third Party. 
 “New Nasha Amended License Agreement”
has the meaning set forth in the Background. 
 “Original License Agreement” has the meaning set forth in the Background. 

“Original Supply Agreement” has the meaning set forth in the Background. 

“Party” has the meaning set forth in the Preamble. 

  
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 “Person” means any individual, firm, corporation, partnership, limited liability company,
trust, joint venture or other entity or organization. 
 “Purchase Price” has the meaning set forth in Section 3.1. 

“Purchasers” means Bioventus’ Affiliates and their permitted Sublicensees. 

“Q-Med” has the meaning set forth in the Preamble. 

“Q-Med Discretionary Changes” has the meaning set forth in Section 2.6(b). 

“Q-Med Excluded Claims” has the meaning set forth in Section 4.6(a). 

“Quality Agreement” means the Amended and Restated Quality Agreement – US, dated as of the date hereof, by and between Q-Med and Bioventus, and attached as Schedule A. 
 “Regulatory Submissions” has the
meaning set forth in Section 2.5. 
 “S&N” has the meaning set forth in the Background. 

“Specifications” means the specifications and the quality control testing procedures for Licensed Product that are set forth or
referenced in Schedule B hereto, as amended from time to time in accordance with this Agreement. All Specifications shall be consistent with applicable Regulatory Approvals. The Parties agree that the Specifications constitute a list at the
effective date of those documents that control the manufacture of the Licensed Product. The documents contained in the Specifications shall be updated and kept current by mutual written agreement, and in accordance with the provisions hereof during
the Term. 
 “Terminating Party” has the meaning set forth in Section 6.3. 

“Unit” means one (1) pre-filled syringe containing three (3) milliliters of Licensed
Product or such other units of Licensed Product as the Parties shall designate and specify in the applicable Specifications. 
 “Visual Non-Conformity” has the meaning set forth in Section 4.2. 
  

	1.2	 Interpretation. 

 

	(a)	 Whenever any provision of this Agreement uses the term “including” (or “includes”), such
term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitations” and “includes but is not limited to”) regardless of whether the words
“without limitation” or “but not limited to” actually follow the term “including” (or “includes”); 

  

	(b)	 “Herein,” “hereby,” “hereunder,” “hereof,” and other equivalent words
shall refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used; 

  
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	(c)	 All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the
singular or the plural; 

  

	(d)	 Unless otherwise provided, all references to Sections, Articles and Appendices are to Sections, Articles and
Appendices of and to this Agreement; 

  

	(e)	 All references to days, months, quarters, or years are references to calendar days, calendar months, calendar
quarters, or calendar years; and 

  

	(f)	 Any reference to any supranational, national, federal, state, local, or foreign statue or law shall be deemed
to also refer to all rules and regulations promulgated thereunder, unless the context requires otherwise. 

 ARTICLE 2.
SUPPLY OF LICENSED PRODUCT 
  

	2.1	 Licensed Product to be Supplied. Subject to Bioventus’ rights set forth in
Section 6.3 hereof, Bioventus shall, and shall cause Purchasers to, purchase from Q-Med, and Q-Med shall sell to Bioventus and the Purchasers, all of their
requirements for the Licensed Product for sale in the Territory for use in only the Licensed Field. Bioventus shall, and agrees to cause the Purchasers to, purchase such Licensed Product from only Q-Med, and
neither Bioventus nor any of the Purchasers shall purchase such Licensed Product from, directly or indirectly, any other Person. Licensed Product will be delivered to Bioventus in finished form for distribution to Bioventus customers and their
distributees. The Licensed Product shall be labeled and packaged as initially specified by Bioventus, consistent with the labeling and packaging elements set forth in the Specifications, and consistent with
Q-Med’s then current manufacturing set-up. Q-Med will use Commercially Reasonable Efforts to accommodate subsequent changes
to the packaging of Licensed Products requested by Bioventus. 

  

	2.2	 Forecasts. 

  

	(a)	 Forecasts and Orders. Commencing prior to, but no later than [***] months before, Market Launch,
and thereafter on or before the last Business Day of each month, Bioventus shall provide a forecast of its and the Purchasers’ estimated monthly requirements of Licensed Product for the [***] month period beginning with the following
month (a “Forecast”). Such beginning month of each Forecast shall be referred to below as “Month 1” and each subsequent month shall be numbered sequentially. The initial Forecast shall be accompanied by Firm Orders for the
quantity of Licensed Product set forth in Months 1, 2 and 3 of such Forecast. The quantities of Licensed Product set forth in Months 4, 5 and 6 of each Forecast after the initial Forecast shall be for a quantity of Licensed Product that is at least
[***] percent ([***]%), but not more than [***] percent ([***]%) (“Firm Order Maximum Quantities”), of the quantities of Licensed Product for months 4, 5 and 6, respectively, in the
immediately prior Forecast. The Forecast will also include the quantities of Licensed Product forecasted for each month after Month 6 up to and including Month 24 of the Forecast, which shall all constitute good faith
non-binding guidance estimates. For example, (i) the Forecast submitted on or before 31 December 2018 shall cover the period from 1 January 2019 through 31 December 2020, (ii) the
quantities of Licensed Product set forth in such Forecast for January 2019, February 2019 and March 2019 shall be Firm Orders, and (iii) the quantities of Licensed Product set forth for April 2019, May 2019 and June 2019 shall be at least
[***] percent ([***]%), and not more than [***] percent ([***]%), of such quantities for such month set forth in the previous Forecast (unless this is the initial Forecast). 

  
 5 

	(b)	 Q-Med shall satisfy all Firm Orders in conformance with the quantity,
delivery, timing and other requirements of each Firm Order and in accordance with the terms of this Agreement; provided that, with respect to any Firm Order, delivery of any quantity that is within [***]% and [***]% of such Firm Order
and within [***] ([***]) Business Days of the date set forth in the Firm Order shall be deemed to be in compliance with the terms hereof. Q-Med shall use Commercially Reasonable Efforts to
procure or be able to procure sufficient raw materials to enable it to meet Firm Order Maximum Quantities. 

  

	(c)	 Failure to Purchase. If Bioventus does not provide Firm Orders for Month 4 or Month 5 that are equal to
at least [***] percent ([***]%) of the quantities of Licensed Product set forth in the most recent Forecast for such months, Q-Med may nonetheless ship, and Bioventus shall pay for, up to
[***] percent ([***]%) of such quantities of Licensed Product, taking into account any Firm Orders actually placed by Bioventus for such months. 

 

	(d)	 Q-Med’s Obligations.
Q-Med shall not be obligated to supply any ordered quantities of Licensed Product for Firm Orders that exceed the [***] percent ([***]%) limits set forth in Section 2.2(a), but Q-Med shall use Commercially Reasonable Efforts to supply such excess quantities within the limitations of its available production capacity and lead times. 

 

	(e)	 Order Limitations. The aggregate minimum order size for each Firm Order shall be [***] Units.

  

	2.3	 Major Forecast Changes. In the event that Bioventus’ orders a number of Units for any
[***] month period in excess of twice the number of Units initially forecasted for such [***] month period, Q-Med shall not be responsible for (and shall have no liability, including pursuant to
Section 6.2, with respect to) the failure to provide any Units in excess [***]% of such initial forecast unless Bioventus has provided Q-Med with written notice of such volume at least [***]
months before the beginning of such 12 month period. 

  

	2.4	 Subcontractors. Q-Med shall have the right in connection
with its obligations hereunder to contract, in whole or in part, with its Affiliates or one or more Third Parties for the Manufacture and supply of the Licensed Product to Bioventus; provided, that:
(i) Q-Med shall cause such contractor to comply fully with the terms and conditions set forth in this Agreement with respect to the Manufacture and supply of the Licensed Product; and (ii) Q-Med shall remain fully responsible for the Manufacture and supply of the Licensed Product to Bioventus. Q-Med shall bear the costs and expense of any required
Regulatory Approvals due to the contracting with any Affiliate or Third Party for the Manufacture and supply of the Licensed Product. The foregoing shall not affect, apply to, prevent or otherwise limit
Q-Med’s right to select and employ Third Party suppliers and subcontractors to provide ingredients, components, parts, and processing activities to aid Q-Med’s
manufacturing process. 

  
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	2.5	 Right of Access to Regulatory Submissions. To the extent
Q-Med maintains device master files for the Licensed Product or other regulatory submissions of Manufacturing information which may be relevant to the Licensed Product (collectively, “Regulatory
Submissions”), Q-Med grants Bioventus the right to cross-reference such Regulatory Submissions for the purpose of obtaining Regulatory Approvals in
accordance with all applicable legal requirements and Q-Med shall provide appropriate letters of access to the applicable Regulatory Authorities in the Territory. 

 

	2.6	 Changes. The Parties shall have the right to request and make changes to the Licensed Product
subject to the provisions of this Section 2.6. Q-Med is the design history file and device master record owner for the Licensed Product. Changes to the Licensed Product will be managed under Q-Med’s design control and/or change control processes as set forth in the Quality Agreement. Bioventus is the holder of Regulatory Approvals for the Licensed Product as described in Article 4 of the New US
License Agreement. Approval for changes to the Licensed Product will be managed under Bioventus’ Regulatory Approvals processes. With respect to any changes to the Licensed Product (regardless of whether it is a Legally Required Change, a Q-Med Discretionary Change or a Bioventus Discretionary Change), Q-Med shall provide Bioventus with reasonable prior written notice of any proposed change to the
Specifications or Manufacturing of the Licensed Product. 

  

	(a)	 Legally Required Changes. Both Parties may initiate changes (“Legally Required
Changes”) in the Specifications, Manufacturing and other changes necessary for the Licensed Product to comply with applicable laws, rules, and regulations, including GMPs, QSRs and the requirements of Regulatory Authorities in the
Territory (collectively, “Laws and Rules”). Both Parties shall work together to update the necessary Specifications and other related design control documentation. Q-Med will conduct or
have conducted the required design control and/or change control activities. Bioventus will review the output and be responsible for acceptability of the final documentation and will make the relevant filings with the applicable Regulatory
Authorities. Any costs for Legally Required Changes, including but not limited to costs for work performed by Q-Med employees, external consultants, translations, and Regulatory Authority filing fees
associated with any such filings, shall be borne by [***]. 

  

	(b)	 Q-Med Discretionary Changes. Q-Med may initiate and make Manufacturing changes which are not Legally Required Changes (“Q-Med Discretionary Changes”). Q-Med shall notify Bioventus in writing of any desired Q-Med Discretionary Change at least [***] ([***]) months prior to the date
Q-Med wishes to implement it. To the extent that any Q-Med Discretionary Change requires Regulatory Approval, Bioventus shall, at
Q-Med’s cost and expense, use Commercially Reasonable Efforts to take all actions reasonably requested by Q-Med in connection therewith including, without
limitation, making Regulatory Filings. Bioventus shall not be financially responsible for any costs or expenses associated with Q-Med Discretionary Changes (for clarity, including any costs or expenses
substantially related to changes requested by Q-Med for compliance with laws and rules for products other than the Licensed Product, costs for work performed by external consultants, translations, and
Regulatory Authority filing fees associated with such filings) or for any increases in the Purchase Price of the Licensed Product. Q-Med shall reimburse Bioventus for all of the costs it incurs in seeking such
Regulatory Approvals, which costs shall include reasonable costs of labor, Regulatory Authority filing fees, consulting fees, and other out of pocket costs of Bioventus. Q-Med shall not implement any Q-Med Discretionary Change requiring Regulatory Approval before such Regulatory Approval is obtained. 

  
 7 

	(c)	 Bioventus Discretionary Changes. Bioventus may initiate and make Manufacturing changes which are not
Legally Required Changes (“Bioventus Discretionary Changes”). Q-Med agrees to implement such changes provided that they are commercially reasonable for
Q-Med, and provided further that Bioventus shall be financially responsible for all of the costs of such changes as described in Section 3.2(a) of this Agreement. In the event that Q-Med believes in good faith that a requested Bioventus Discretionary Change is not commercially reasonable, it shall provide Bioventus with the reasons therefor and supporting documentation in connection therewith,
and the Parties shall explore in good faith alternative changes that would be commercially reasonable for Q-Med. 

  

	(d)	 Changes to Specifications. Notwithstanding anything in this Section 2.6, and for the avoidance of
doubt, any changes to the Specifications must be mutually agreed to by Q-Med and Bioventus. 

  

	2.7	 Secure Manufacturing Source. Q-Med shall use its
Commercially Reasonable Efforts to maintain capacity or inventory sufficient to meet Bioventus’ requirements of Licensed Product as indicated in the Forecasts. At the written request of either Party, appropriate personnel from each Party will
meet and discuss their then current views on the markets and demand for Licensed Product, current and planned marketing plans and initiatives and other matters pertaining to capacity and inventory planning that such Party may reasonably wish to
discuss. If at any time Q-Med reasonably believes that it may not have sufficient capacity or inventory to fulfill the requirements so forecasted by Bioventus (a “Capacity Shortage”),
whether due to insufficient manufacturing capacity or otherwise (including any of the reasons described in Section 9.2), Q-Med shall promptly notify Bioventus. If
Q-Med has a plan of action with respect to such Capacity Shortage when it delivers such notice, Q-Med shall provide Bioventus with a written outline of such plan and its
reasonably supported conclusions relating thereto. Q-Med may take prompt action with respect to such plan or, if Q-Med desires,
Q-Med may promptly convene a meeting between Bioventus and Q-Med to discuss such plan. If Q-Med has not developed a plan of
action at the time of its notice to Bioventus of the Capacity Shortage, Q-Med shall promptly convene a meeting between Bioventus and Q-Med to develop in mutual
consultation a commercially reasonable course of action with respect to such Capacity Shortage. As soon as practicable after such meeting, Q-Med shall use Commercially Reasonable Efforts to carry out such
mutually determined plan of action. If such plan of action includes the use of a Third Party contract manufacturer, Q-Med shall use Commercially Reasonable Efforts to contract with a Third Party to Manufacture
such Licensed Product and supply the Purchasers. Q-Med shall in good faith negotiate the grant to such Third Party of license to so Manufacture such Licensed Product on the terms set forth in Schedule 6.2 and
provide such other assistance as may be required to enable such Third Party to validate a manufacturing facility and commence the Manufacture of such Licensed Product in accordance with the applicable Specifications and GMP. Upon resumption of
sufficient capacity at Q-Med’s facilities to fulfill Bioventus’ orders, Q-Med shall, subject to the terms and conditions of that Third Party license, resume
the Manufacture and supply of orders in accordance with the terms set forth in Section 2.2. 

  
 8 

	2.8	 Guaranty. Guarantor hereby unconditionally and irrevocably guarantees to Bioventus the
performance in full of Q-Med’s obligations under this Agreement. 

 ARTICLE
3. CONSIDERATION 
  

	3.1	 Pricing. 

  

	(a)	 Price. The purchase price of the Licensed Product shall be SEK [***] per [***] Unit of
Licensed Product. 

  

	(b)	 Price Adjustments. The purchase price of the Licensed Product shall not increase for the first
[***] ([***]) years following Regulatory Approval in the United States. Adjustments to the purchase price thereafter shall be made in accordance with Section 3.2 hereof, and increases or decreases shall not be made more than
[***] every year unless there is a Legally Required Change, and then in such case, not more than [***] every [***] ([***]) months and only in accordance with Section 3.2 hereof. 

 

	(c)	 Samples. The purchase price for Licensed Products that are used as samples shall be SEK [***] per
Unit. The amount of such samples purchased by Bioventus in the initial Royalty Year shall not exceed [***] percent ([***]%) of the total Units purchased for the initial Royalty Year, and for any subsequent Royalty Year shall not exceed
[***] percent ([***]%) of the total Units purchased for such Royalty Year. This Section 3.1(c) shall be of no further force and effect upon the license granted to Bioventus in Section 2.1 of the New US License Agreement being
converted to a non-exclusive license in accordance with the terms thereof. 

  

	(d)	 Each such price, as adjusted as provided above or in Section 3.2, shall be referred to as the
“Purchase Price”. 

  

	3.2	 Bases for Purchase Price Adjustments. Adjustments to the Purchase Price for each Licensed
Product as contemplated in Section 3.1(b) hereof may be based upon: 

  

	(a)	 changes in costs of the Licensed Product as a result of Bioventus Discretionary Changes; 

 

	(b)	 changes in manufacturing costs or market conditions; and 

 

	(c)	 changes in costs of the Licensed Product as a result of Legally Required Changes, as described in
Section 2.6(a). 

  
 9 

 If either Party desires to propose a Purchase Price adjustment, it shall provide the other
Party with at least [***] ([***]) days’ notice, accompanied by written documentation demonstrating such cost changes and explaining the reasons therefor. If the Parties are unable to agree on a purchase price adjustment for a
Licensed Product, the Chief Executive Officers of each of the Parties will meet to discuss the proposed purchase price adjustment in good faith. 
  

	3.3	 Payment Obligations. 

 

	(a)	 Invoices for the Purchase Price shall be issued upon shipment and shall be payable in SEK within [***]
([***]) days thereafter. 

  

	(b)	 All payments shall be made by wire transfer to an account designated in writing by Q-Med at least [***] Business Days prior to the date such payment is due or as specified in such invoice. Any required payment hereunder not made by Bioventus on or before the date specified in this
Section 3.3 shall bear interest from the date such payment is due until the date it is actually received by Q-Med at an annual rate equal to the rate of interest per annum publicly announced from time to
time by JPMorgan Chase Bank as its prime rate in effect on the date such payment is due at its principal office in New York City, plus [***] percent ([***]%) (or the highest rate permitted by law, if lower).
Notwithstanding the foregoing, if at any time Bioventus has failed to make a payment in full when due (a “Delinquent Payment”) and the aggregate amount of such Delinquent Payment exceeds [***] percent ([***]%)
of the value of the most recently placed Firm Order, Q-Med shall automatically be entitled to pre-payment for all subsequent deliveries until such Delinquent Payment has
been paid in full with interest from and including the date such Delinquent Payment was due (such interest to be determined in accordance with the immediately preceding sentence) but excluding the date of payment. 

 

	(c)	 The payments pursuant to this Article 3 are exclusive of all taxes and shall be made without deductions for
taxes, assessments, fees or charges of any kind. If Bioventus is required by law to withhold any tax to the tax or revenue authorities in any country regarding any payments or royalties, such amount shall be deducted from the amounts to be paid by
Bioventus, and Bioventus shall notify Q-Med and promptly furnish Q-Med with copies of any tax certificate or other documentation evidencing such withholding. Each Party
agrees to cooperate with the other Party in claiming exemptions from or collecting such deductions or withholdings under any agreement or treaty from time to time in effect. All payments to Q-Med shall be made
by Bioventus from the United States. 

 ARTICLE 4. DELIVERY AND WARRANTY 

 

	4.1	 Purchases, Shipments and Delivery. 

 

	(a)	 Delivery Terms. Q-Med shall deliver the Licensed Product FCA
(INCOTERMS 2010) Q-Med facility – [***] or such other facility as permitted under this Agreement, and Q-Med shall, on behalf of Bioventus and at
Bioventus’ expense, make such arrangements for shipping and export as may be instructed by Bioventus. Q-Med shall not be required to ship the Licensed Product to more than [***] ([***])
destinations. Q-Med shall so deliver the Licensed Product with a shelf life of at least [***]% of total shelf life. 

  
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	(b)	 Orders. Q-Med’s sales of Licensed Product shall be subject
to the terms and limitations of this Agreement and not to any Bioventus purchase order, Q-Med order acknowledgement or other document not effectively amending this Agreement, except insofar as such order or
other document establishes: (i) the quantity of Licensed Product sold; (ii) the delivery date of Licensed Product; or (iii) the destination of shipment of Licensed Product. Any additional, inconsistent or different terms and
conditions contained in such other documents are hereby expressly rejected. 

  

	(c)	 Packing List. Q-Med shall include a packing list in each
shipment of Licensed Product which shall provide the following information: (i) Bioventus purchase order number, (ii) quantity, (iii) Q-Med lot number, (iv) commercial invoice; and
(v) any other legally required documentation. An electronic copy of this information shall be provided as an advance shipping notice upon delivery for shipment. 

 

	4.2	 Licensed Product Acceptance. Bioventus shall be entitled to reject all or any portion of a
shipment of Licensed Product within [***] ([***]) Business Days of Bioventus’ receipt of such shipment of Licensed Product based solely on obvious physical, packaging or Labeling damage or defect that would be evident upon visual
inspection of the packaged Licensed Product and discoverable without affecting the integrity of the Licensed Product packaging, as shipped by Q-Med (unless such obvious physical, packaging or Labeling damage
or defect was attributable to an act or omission of Bioventus or any of its Affiliates or any carrier after delivery by Q-Med in accordance with Section 4.1(a) (a “Visual Non-Conformity”)). If Bioventus does not provide notice within such time period, then Bioventus shall be deemed to have accepted such Licensed Product and waived its right to reject the shipment
based upon a Visual Non-Conformity. Bioventus shall provide Q-Med with written notice of any such rejection within the period set forth above together with a reasonably
detailed statement to support any such rejection. Q-Med shall notify Bioventus as promptly as reasonably possible, but in any event within [***] ([***]) Business Days after receipt of such
written notice, whether it agrees with Bioventus’ assertions with respect thereto. If Q-Med agrees with such assertions, all such rejected Licensed Product shall be returned to Q-Med together with the notice of rejection, a copy of the delivery receipt and the reasonably detailed statement of Bioventus’ reasons for rejection and Q-Med shall
replace such Licensed Product and shall reimburse Bioventus for the cost of shipping (including insurance). If Q-Med does not agree with Bioventus’ assertions and Bioventus does not accept Q-Med’s determination, then the Parties shall refer the dispute to a mutually acceptable independent testing laboratory for final resolution. If such independent laboratory affirms Bioventus’ finding of a
Visual Non-Conformity, Q-Med shall promptly supply Bioventus with the same quantity of such Licensed Product so found to be
non-conforming. The cost of such independent laboratory shall be borne by the Party whose findings are contrary to the findings of such independent laboratory. While any dispute regarding nonconformity of
Licensed Product is pending, Q-Med, using its Commercially Reasonable Efforts, shall replace any shipment or portion of a shipment under dispute, and Bioventus shall pay the applicable Purchase Price, subject
to a credit if such dispute is resolved in Bioventus’ favor. 

  

	4.3	 Latent Defects. The Parties acknowledge that it is possible for Licensed Product to have defects
that are not discoverable upon the visible inspection of the packaged Licensed Product (referred to herein as a “Latent Defect”). Latent Defects may include, by way of illustration and not definition or limitation, defects
not present in preshipment samples, loss of stability or other manufacturing defects. Q-Med is responsible for all Latent Defects to the extent expressly provided for in this Agreement. 

  
 11 

	4.4	 Warranties. 

  

	(a)	 Licensed Product Warranty. Q-Med warrants to Bioventus that it
will deliver Purchasers good title to the Licensed Product free and clear of any liens, claims, charges or encumbrances. Q-Med further represents and warrants to Bioventus that Licensed Product when delivered
in accordance with Section 4.1: (i) shall be Manufactured in accordance and conformity with the then applicable Specifications, (ii) shall not be adulterated or misbranded as defined in the FDCA (except to the extent arising out of
Labeling provided or specified by Bioventus or marketing, promotional or sales practices by any of the Purchasers) and (iii) shall be Manufactured in compliance with GMP. 

 

	(b)	 Remedy. Provided that Q-Med receives, within [***]
([***]) months after delivery, prompt written notice of a nonconformity with its foregoing warranties, Q-Med, at its option and expense, will furnish Bioventus a credit, refund or replacement of such
nonconforming Licensed Product. 

  

	(c)	 Exclusions. Q-Med’s warranties do not apply to the extent
any breach thereof arises out of any defect in a device provided or specified by Bioventus. 

  

	(d)	 THE FOREGOING WARRANTIES BY Q-MED ARE EXCLUSIVE AND IN LIEU OF ALL
OTHER WARRANTIES OF QUALITY AND PERFORMANCE, WRITTEN, ORAL OR IMPLIED, AND ALL OTHER WARRANTIES INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY
Q-MED, ITS AFFILIATES AND THEIR SUBCONTRACTORS. 

  

	(e)	 Exclusive Remedies. Correction of nonconformities in the manner and for the period of time provided
above shall be Bioventus’ exclusive remedy and shall constitute fulfillment of all liabilities of Q-Med, its Affiliates and their subcontractors (including any liability for direct, indirect, special,
incidental or consequential damages), whether in warranty, contract, negligence, tort, strict liability, or otherwise, with respect to any nonconformance of or defect or deficiency in the Licensed Product, except to the extent provided in
Section 4.6 below. 

  

	4.5	 Legal Compliance. In the Manufacture of the Licensed Product,
Q-Med shall comply in all material respects with all applicable Laws and Rules, including those relating to the environment, health and safety. Following delivery of the Licensed Product, Bioventus shall
comply in all material respects with all applicable Laws and Rules, including those relating to the environment, health and safety, and with all applicable GMP and customary industry practices relating to handling, storage and distribution.

  

	4.6	 Indemnity. 

  
 12 

	(a)	 In addition to the indemnification provided for in Section 10.2 of the New US License Agreement and
subject to the terms set forth in Section 4.6(b) below, Q-Med shall indemnify, defend and hold harmless the Bioventus Indemnified Parties from and against any and all liability, claims, damage, or loss
(including reasonable attorneys’ and expert fees and expenses) arising out of or in connection with Third Party claims made or legal proceedings instituted against the Bioventus Indemnified Parties for bodily injuries, including death, or
tangible property damage suffered or incurred by a patient to the extent caused by (i) the negligence of Q-Med in the development or manufacture of a Licensed Product, (ii) a design defect in the
Licensed Product, (iii) a breach of the warranty set forth in Section 4.4 (“Licensed Product Claims”), or (iv) breach of the Quality Agreement; provided, that
Q-Med shall not be so liable to the extent any Licensed Product Claims result from a Licensed Product that following delivery to Bioventus in accordance with Section 4.1: (x) is not handled, stored, used
and otherwise managed in accordance with the Labeling (including uses indicated in the Labeling approved by the applicable Regulatory Authority) or clinical protocols, as applicable; (y) was used after expiration of the Licensed Product’s
labeled shelf life; or (z) has been modified or combined in any way with any other products in a manner not permitted or recommended by the Labeling for such Licensed Product (“Q-Med
Excluded Claims”); provided, further, Q-Med shall not be obligated under this Section 4.6, and Q-Med Excluded Claims shall be
deemed to include, any Licensed Product Claims arising out of: (yy) the injection or other use of needles, syringes or other delivery devices to administer a Licensed Product, including claims of pain, swelling and redness from the use of such
needles, or (zz) known adverse effects listed on the Licensed Product Labeling. 

  

	(b)	 Each Party’s indemnification obligation under Section 4.6 shall be subject to the same procedure and
other rights set forth in Section 10.4 of the New US License Agreement. The exercise by a Party of its right to control the defense and settlement of a claim or action pursuant to Section 10.4 of the New US License Agreement shall not
constitute a waiver of any limitation on indemnification set forth in this Section 4.6 or the right of Q-Med to reimbursement for any expense (including reasonable attorneys’ and expert fees and
costs) incurred in defending claims made or legal proceedings instituted against the Bioventus Indemnified Parties that are not covered by Section 4.6(a). In seeking indemnification pursuant to Section 4.6(a), the Bioventus Indemnified
Parties shall, in addition to complying with the procedures in Section 10.4 of the New US License Agreement, provide with the written notice to Q-Med required under Section 10.4 of the New US License
Agreement all information pertinent to such claims or proceedings, including all available information covered by Section 4.7, patient medical records, statements, reports, and demands, subject to compliance with applicable Laws and Rules
relating to the privacy of patient records. 

  

	(c)	 Q-Med’s liability in respect of Licensed Product Claim indemnity
obligation under Section 4.6(a)(iii) does not extend to Licensed Product Claims arising out of the labeling, the marketing or sales practices of Bioventus or other matters for which Bioventus is responsible under Section 10.2 of the New US
License Agreement. For the avoidance of doubt, nothing contained herein shall limit the rights and obligations set forth in Section 4.4(b) hereof. 

  
 13 

	(d)	 Bioventus shall implement all reasonable safety measures, including new or modified warnings or instructions to
patients or health care professionals, recommended in writing by Q-Med regarding the Licensed Product. Q-Med shall not have any liability under Section 4.6 for
Licensed Product Claims resulting from or arising out of Bioventus’ breach of this section. 

  

	(e)	 Bioventus shall indemnify, defend and hold harmless the Q-Med
Indemnified Parties from and against any and all liability, claims, damage, or loss (including reasonable attorneys’ and expert fees and expenses) arising out of or in connection with Third-Party claims
made or legal proceedings instituted against the Q-Med Indemnified Parties for bodily injuries, including death, or tangible property damage suffered or incurred by a patient to the extent resulting from any
Bioventus Discretionary Change or Q-Med Excluded Claim. 

  

	(f)	 Q-Med shall indemnify, defend and hold harmless the Bioventus
Indemnified Parties from and against any and all liability, claims, damage, or loss (including reasonable attorneys’ and expert fees and expenses) arising out of or in connection with Third Party claims made or legal proceedings instituted
against the Bioventus Indemnified Parties for bodily injuries, including death, or tangible property damage suffered or incurred by a patient to the extent resulting from any Q-Med Discretionary Change.

  

	4.7	 Licensed Product Complaints. Bioventus shall cooperate with
Q-Med in investigating and resolving customer complaints concerning the Licensed Product, including, to the extent practicable and feasible, obtaining relevant medical records, interviewing the administering
physician and obtaining such other information as is necessary to a full understanding of the patient’s complaint, subject to compliance with applicable laws relating to the privacy of patient records. Among other things, the Parties shall
promptly establish and implement a system for exchange of complaint and adverse event information between the Parties sufficient to allow each Party to comply with its respective indemnification obligations hereunder and under the New US License
Agreement and adverse event reporting obligations, which shall include appropriate provisions for recording worldwide customer complaints relating to Licensed Product and prompt notice to the other Party of significant and/or potentially reportable
adverse events. Bioventus shall cooperate fully with Q-Med in dealing with product complaints concerning the Licensed Product and shall take such action to promptly resolve such complaints as may be reasonably
requested by Q-Med. Bioventus shall provide accurate and timely information to Q-Med about all complaints and adverse events, and shall otherwise cooperatively undertake
investigations and provide information and analysis as reasonably requested by Q-Med. Bioventus shall provide appropriate medical advisory support to patients and physicians concerning the use of the Licensed
Product and responding to product complaints and adverse events. 

 ARTICLE 5. REPRESENTATIONS AND WARRANTIES 

 

	5.1	 Representations. Each Party hereby represents and warrants that: 

 

	(a)	 It is duly organized, validly existing and in good standing under the laws of its jurisdiction of organization
and has all requisite corporate power and authority to own and operate its properties and assets, to execute and deliver this Agreement and to perform its obligation hereunder. 

  
 14 

	(b)	 Its execution, delivery and performance of this Agreement have been duly authorized by it and this Agreement
will be, upon its execution and delivery, a valid and binding legal obligation of it, enforceable in accordance with its terms. 

  

	(c)	 The execution, delivery and performance of this Agreement does not and will not (i) violate, conflict with
or result in the breach of any provision of its corporate charter or by-laws (or similar organizational documents), (ii) violate or conflict with any law or governmental order applicable to it or its assets,
properties or businesses, or (iii) conflict with, result in a breach of, constitute a default (or event which with the giving of notice or lapse of time, or both, would become a default) under, require any consent under, or give to others any
rights of termination, amendment, acceleration, suspension, revocation or cancellation of, or result in the creation of any encumbrance on any of its outstanding shares of capital stock or any of its assets or properties pursuant to any note, bond,
mortgage, indenture, contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which it is a party or by which any of its shares of capital stock or any of its assets or properties is bound or affected.

  

	(d)	 Other than as expressly stated in this Agreement, no permit, approval, authorization or consent of any Person
is required in connection with the execution, delivery and performance by it of this Agreement or the consummation of the transactions contemplated hereby. 

  

	5.2	 Additional Representations by Q-Med. Q-Med further represents, warrants and covenants, as of the Amendment Effective Date, that: 

  

	(a)	 Q-Med has the legal power to extend the rights granted to Bioventus
under this Agreement and that it has not made, and throughout the term of this Agreement will not make, any commitments to others inconsistent with such rights. 

 

	(b)	 Q-Med has received no notice from any governmental authority to the
effect that it has not materially complied with or is not now in material compliance with material Laws and Rules relating to the Manufacture of the Licensed Product. 

 

	(c)	 There are no claims, actions, suits or other proceedings pending, or to the knowledge of Q-Med, threatened which, would reasonably be expected to materially and adversely affect the ability of Q-Med to perform its obligations hereunder. 

 

	(d)	 Q-Med has not filed for bankruptcy, is not insolvent, has not proposed
a compromise or arrangement to its creditors generally, has not had any petition or a receiving order in bankruptcy filed against it, has not made a voluntary assignment in bankruptcy, has not taken any proceeding with respect to a compromise of
arrangement with its creditors, has not taken any proceeding to have it declared either bankrupt or liquidated, has not taken any proceeding to have a receiver appointed for any part of its assets, and has not had any execution, charging order, levy
or distress warrant become enforceable or become levied upon any of its assets. 

  

	(e)	 To the knowledge of Q-Med, there have been no claims or judicial
proceedings concerning the Q-Med Manufacturing Technology and no such claims have been threatened. 

  
 15 

	5.3	 NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 4.4 OR IN THE NEW
US LICENSE AGREEMENT, Q-MED MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER AT LAW OR IN EQUITY, RELATED TO THE LICENSED PRODUCT, INCLUDING ANY REPRESENTATION OR WARRANTY AS TO VALUE,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR FOR ORDINARY PURPOSES, OR ANY OTHER MATTER. 

 ARTICLE 6. TERM AND
TERMINATION 
  

	6.1	 Term. Unless earlier terminated in accordance with Section 6.2 or 6.3, this Agreement shall remain
in force until (and including) the termination or expiration of the New US License Agreement. 

  

	6.2	 Manufacturing License. For purposes of this Agreement, a “Major Supply Default”
means a failure to supply at least [***] percent ([***]%) of the aggregate quantities of Licensed Product required under any Firm Orders in [***] ([***]) consecutive months and does not cure such shortfall by
supplying such shortfall within the subsequent [***] ([***]) months. Upon the occurrence of a Major Supply Default, Bioventus shall be entitled to terminate the Agreement effective immediately upon written notice to Q-Med. In addition and without limiting the other rights, remedies and obligations set forth this Agreement, upon the occurrence of a Major Supply Default (regardless of whether Bioventus has terminated the
Agreement in accordance with the foregoing), Q-Med shall do the following at its sole cost and expense (the “Manufacturing License Actions”): 

 

	(a)	 assist Bioventus in identifying alternative suppliers for the Licensed Product; 

 

	(b)	 upon Bioventus’ instruction, grant to Bioventus or to a Third Party reasonably acceptable to Bioventus
(the “Manufacturing Licensee”) the right to Manufacture the Licensed Product on the following terms (the “Manufacturing License”): Q-Med shall grant an
irrevocable, royalty-free, exclusive license under the Q-Med IP to manufacture the Licensed Product in the Licensed Field in the Territory, including the right to
sublicense its license rights to Bioventus Affiliates and Third Party contract manufacturers. For clarity, at Bioventus’ option, the grant of the Manufacturing License may be accomplished by deeming that the license grant in Section 2.1 of
the New US License Agreement is amended to include manufacturing. 

  

	(c)	 promptly, but in any event within [***] days after the Manufacturing Licensee is engaged, provide
Bioventus or the Manufacturing Licensee, as applicable, copies of all tangible embodiments of Q-Med Manufacturing Technology then being used by Q-Med or any of its Third
Party contract manufacturers to Manufacture the applicable Licensed Product, including all analytical and process techniques, standard operating procedures and batch records. Q-Med shall also provide all
reagents and analytical standards used to conduct such analytical methods conducted by Q-Med and which are not commercially available. 

  
 16 

	(d)	 Q-Med shall further provide such technical assistance as may be
reasonably required to enable Bioventus or a competent and experienced contract manufacturing organization to Manufacture the Licensed Product using the Q-Med Manufacturing Technology. All such services shall
be provided at Q-Med’s expense, except for out-of-pocket travel costs. 

 

	(e)	 assist with training and transfer of the information and technology necessary to Manufacture the Licensed
Product, including access to key personnel with know-how regarding the Manufacture of the Licensed Product; 

  

	(f)	 grant access to Q-Med’s manufacturing facility for a reasonable
period of time, during regular business hours, as necessary to accomplish the transfer of the manufacturing of the Licensed Product to Bioventus or the Manufacturing Licensee, as quickly as possible; and 

 

	(g)	 use Commercially Reasonable Efforts (including, as appropriate, assignment of agreements to Bioventus or the
Manufacturing Licensee) to cause Q-Med’s raw material and component suppliers to supply such components and raw materials that are necessary for the Manufacture of the Licensed Product to be supplied
directly to Bioventus or the Manufacturing Licensee, as applicable, to the same extent supplied to Q-Med for the manufacture of the Licensed Product prior to the Major Supply Default. 

In the event a Manufacturing License is granted hereunder: (i) no additional compensation shall be payable to
Q-Med with respect to the Manufacturing License other than the Variable Royalty otherwise payable under the New US License Agreement; (ii) the Variable Royalty payable under the New US License Agreement
shall be reduced by the Purchase Price per Unit of Licensed Product sold; (iii) Bioventus’ obligation to pay the Variable Royalty under the New US License Agreement shall end on the [***] ([***]) year anniversary of the
granting of the Manufacturing License, and thereafter the Manufacturing License shall be completely royalty free and paid up; (iv) Q-Med shall not be responsible for any Licensed Product Manufactured by
or for Bioventus under such Manufacturing License, except pursuant to clause (ii) of Section 4.6(a) of the Agreement; and (v) Q-Med shall not be obligated to supply Licensed Product to Bioventus
in any specified quantities after a Third Party contract manufacturer commences delivering Licensed Product to Bioventus. If Bioventus uses a Third Party contract manufacturer to Manufacturer any Licensed Product, then, upon the expiration or
termination of the supply contract with such Third Party contract manufacturer, if Q-Med has resolved the issues that caused the Major Supply Default, Bioventus will provide
Q-Med with a reasonable opportunity to negotiate mutually acceptable terms for Q-Med to be reinstated as the manufacturer of the associated Licensed Products (provided
that Q-Med shall be responsible for Bioventus’ reasonable expenses related thereto). Nothing in Section 6.2 shall limit the remedies or rights of Bioventus in the event of a Major Supply Default and
Bioventus’ rights under Section 6.2 shall be in addition to all other remedies available under this Agreement at law or in equity. The foregoing notwithstanding, in no event shall Q-Med be obligated
to grant a Manufacturing License hereunder (i) if the Major Supply Default is caused by a Force Majeure that lasts less than [***] months or (ii) if at the time of the Major Supply Default the then current Minimum Sales Requirement
is less than [***] Units. 

  
 17 

	6.3	 Early Termination. If either Party (“Breaching Party”) commits a material
breach of its obligations under this Agreement (other than a Major Supply Default, which termination right shall be governed by Section 6.2 hereof), the other Party (“Terminating Party”) may terminate this Agreement in
accordance with the terms hereof. The Terminating Party shall provide written notice to the Breaching Party, which notice shall identify the material breach, the intent to so terminate and the actions or conduct that it considers would be an
acceptable cure of such breach. The Breaching Party shall have a period of [***] ([***]) days (or, in respect of any payment default, [***] ([***]) days) after such written notice is provided to cure such breach. If such
breach is not cured within such [***] ([***]) or [***] ([***]) day period, as applicable, the Agreement shall be terminated. 

  

	6.4	 Effect of Termination or Expiration. 

 

	(a)	 Upon termination of this Agreement pursuant to Section 6.3, Q-Med
will furnish to Bioventus a complete inventory of all work-in-progress for the Manufacture of the Licensed Product and an inventory of all finished Licensed Product.
Unless otherwise agreed to between the Parties, all stock on hand as of such termination will be dealt with promptly as provided in Section 12.6 of the New US License Agreement. 

 

	(b)	 Upon termination of this Agreement pursuant to Section 6.3, each of Bioventus and Q-Med will immediately at its expense return to the other Party all proprietary and confidential documents, work papers and other material of the other Party and its Affiliates relating to the transactions
contemplated hereby obtained from that other Party or its Affiliates pursuant to this Agreement, whether so obtained before or after the execution hereof, and all copies, extracts or other reproductions, in whole or in part thereof which may have
been made by or on behalf of Bioventus or Q-Med or their respective representatives, as the case may be, and shall deliver to the other Party or destroy all notes or memorandum or other stored information of
any kind containing, reflecting or derived from such documents, work papers and other material, except that Bioventus shall have the right to retain one archival copy, which may be retained by each Party’s outside counsel or in-house counsel, which copy retained by Bioventus may be used in connection with its compliance with applicable Laws and Rules. The return or destruction, as applicable, of such documents, work papers and other
material (and all copies, extracts or other reproductions in whole or in part thereof) pursuant to this Section 6.4(b) shall be certified in writing by an authorized officer supervising the same. Notwithstanding such return or destruction, each
Party will continue to be bound by its obligations of confidentiality under Article 8 herein. Each Party shall not use or disclose to any Person any information derived from such confidential and proprietary documents, work papers and other material
of the other Party and shall be responsible for preventing the disclosure of any such information as provided in Article 8. 

  

	(c)	 Upon termination of this Agreement, all obligations of the Parties hereunder shall terminate, except for
Sections 4.5, 4.6, 6.4, 7.2 and Articles 8 and, to the extent requires to give effect to the foregoing, Articles 1 and 9; provided, that termination will not relieve a defaulting or breaching Party from any liability to the other Party
hereto, including the obligation to pay invoiced amounts when due. Termination shall not relieve either Party from obligations that are indicated to survive termination or expiration of this Agreement. Termination is not the sole remedy under this
Agreement and, whether or not termination is effected, all other remedies will remain available, except as agreed to or otherwise expressly provided for herein. For the avoidance of doubt, termination of this Agreement shall not affect the
obligation of Bioventus or its affiliates from paying royalties owed pursuant to the New US License Agreement. 

  
 18 

	6.5	 Q-Med Sole Suppliers. 

 

	(a)	 During the period beginning on the Amendment Effective Date and ending on the date [***], any
interruption in Q-Med supplying Licensed Products to Bioventus under this Agreement shall not be considered a failure to supply for purposes of determining whether a Major Supply Default has occurred, or
otherwise be a breach of this Agreement, to the extent that such interruption is due to problems that are the fault of [***]. For the avoidance of doubt, the above provision in this Section 6.5 shall automatically become null and void
without any action by the Parties as soon as a second HA supplier is approved by the FDA. 

  

	(b)	 During the period beginning on the Initial Regulatory Approval Date, any interruption in Q-Med supplying Licensed Products to Bioventus under this Agreement shall not be considered a failure to supply for purposes of determining whether a Major Supply Default has occurred, or otherwise be a breach of
this Agreement, to the extent that such interruption is due to problems that are the fault of [***] of any component or any raw material necessary for the production of the Licensed Products, where FDA approval of a replacement for
[***] of such component or raw material is required and (i) Q-Med requested Bioventus to seek FDA approval of [***] at least [***] ([***]) months prior to the interruption; and
(ii) Bioventus failed (y) to file for FDA approval of [***] within [***] ([***]) days after receipt of Q-Med’s written notice, or (z) to use Commercially Reasonable
Efforts to seek FDA approval of [***] after filing. For the avoidance of doubt, this Section 6.5(b) shall not apply to the initial FDA approval of a [***] as that situation shall be governed by Section 6.5(a).

 ARTICLE 7. INSPECTION OF MANUFACTURING FACILITIES 

 

	7.1	 Inspection Rights. Upon [***] weeks’ prior written notice to
Q-Med, Q-Med will permit Bioventus and Affiliates to conduct an inspection and audit of Q-Med’s and/or its Affiliates’
manufacturing facilities and operations to the extent used in the manufacturing, receiving, sampling, analyzing, storing, handling, packaging and shipping of Licensed Product for Bioventus in the Territory, including the receipt, storage and
issuance of raw materials, labeling and packaging components and ingredients thereof (including all documentation related thereto) for the purpose of quality control and to assure compliance with GMP, applicable Laws and Rules and the terms of this
Agreement. Bioventus may not conduct an audit hereunder or pursuant to the New US License Agreement more frequently than once during any twelve (12) month period; provided, that additional audit(s) may be conducted in the event there is
a quality or compliance issue concerning a Licensed Product for Bioventus or its manufacture that Bioventus deems in good faith to be material hereunder. Bioventus may conduct such audit using its own personnel, the personnel of a Bioventus
Affiliate, or a Third Party auditor/inspector and shall conduct such audit, or cause such audit to be conducted, during regular business hours and in such a manner so as to minimize interference with
Q-Med’s operations. Q-Med will provide Bioventus with access to relevant personnel during the audit and Q-Med will provide a
written response to any written audit observations provided by Bioventus within [***] ([***]) days of Q-Med’s receipt thereof. In the event that the facilities used by Q-Med to produce Licensed Product are the subject of an audit or inspection by FDA or a similar Regulatory Authority relating to the manufacture of a Licensed Product for Bioventus,
Q-Med shall notify Bioventus, and, if possible under the circumstances, Bioventus or its Affiliates or representatives shall have the right to be present during such audit or inspection. The foregoing
notwithstanding, Bioventus’ or its Affiliates’ regulatory affairs staff may with prior written notice to Q-Med make non-audit visits to Q-Med’s facilities for the purpose of assisting in preparation for FDA or other Regulatory Authority visits. Bioventus acknowledges that any non-public and proprietary
information provided to Bioventus during the course of such audit (regardless of whether it is marked as confidential) shall be deemed Confidential Information as defined in Section 11 of the New US License Agreement for as long as it does not
fall under the exceptions in Section 11.3 of the New US License Agreement. 

  
 19 

	7.2	 Records. Q-Med shall keep complete, accurate and detailed
original records pertaining to the Manufacture, including quality control of each lot, of Licensed Product produced and manufactured by Q-Med or its Affiliates hereunder. Records shall be maintained for the
longer of (i) any period required under applicable law, and (ii) a period of two (2) years after expiry of the expiration dating of such lot. For validation batches, Q-Med shall keep the
documents throughout the commercial life of the relevant Licensed Product. Q-Med shall make available to Bioventus such records (including making copies thereof) without unreasonable delay to the extent
reasonably requested and required by Bioventus to comply with its regulatory and other legal requirements. 

  

	7.3	 Regulatory and Quality Cooperation. 

 

	(a)	 Q-Med shall promptly, and in any event, within [***]
([***]) Business Days of becoming aware, notify Bioventus of any quality, materials or manufacturing issues that arise that are likely to affect the Commercialization or marketability of the Licensed Product. Without limiting the foregoing
and in addition any rights and obligations set forth in the Quality Agreement, Q-Med will notify Bioventus promptly if (i) Q-Med (or its authorized agents) is
served with notice of violation of any law, regulation, permit or license which relates to the materials, quality or manufacturing of the Licensed Product; (ii) proceedings are commenced which could lead to revocation of permits of licenses
which relate to the materials, quality or manufacturing of the Licensed Product; or (iii) any safety issues or regulatory actions with respect to the safety of the Licensed Products have been initiated by
Q-Med or a Regulatory Authority, including but not limited to adverse events, corrective actions, recalls, clinical holds, restrictions on distribution, dosage modification or formulation changes for safety
reasons. In addition, Q-Med will timely share any findings with Bioventus resulting from any audits or investigations conducted by or on behalf of Q-Med, its Affiliates
or Regulatory Authorities that are likely to affect the Commercialization or marketability of the Licensed Product, or that otherwise affect the safety and quality of the Licensed Product. In addition to the foregoing, the Parties shall comply with
the notification requirements relating to the Licensed Product as set forth in the Quality Agreement. 

  

	(b)	 Bioventus shall promptly, and in any event within [***] ([***]) Business Days, notify Q-Med of any instance where Bioventus has actual knowledge that Licensed Product (i) was not handled, stored, used and otherwise managed in accordance with the Labeling (including uses indicated in the Labeling
approved by the applicable Regulatory Authority) or clinical protocols, as applicable; (ii) was used after expiration of the Licensed Product’s labeled shelf life; or (iii) has been modified or combined in any way with any other
products in a manner not permitted or recommended by the Labeling for such Licensed Product. 

  
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 ARTICLE 8. CONFIDENTIALITY 

The terms and provisions of Article 11 of the New US License Agreement are incorporated herein by reference and each Party agrees to be bound by such terms
and provisions as if expressly stated herein. All non-public and proprietary data and information disclosed pursuant to this Agreement, including all batch records, Certificates of Analysis, information
disclosed pursuant to Section 7.3 hereof, and other information relating to the manufacture of the Licensed Product (regardless of whether it is marked as confidential), shall be deemed “Confidential Information” as defined in
Section 11 of the New US License Agreement and subject to the confidentiality provisions thereof for as long as it does not fall under the exceptions in Section 11.3 of the New US License Agreement. In no event shall Bioventus have the
right to use or disclose any Q-Med Manufacturing Technology except to the extent expressly permitted under Section 11.1 of the New US License Agreement or as permitted in the event of a Major Supply
Default. 
 ARTICLE 9. MISCELLANEOUS 
  

	9.1	 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY OR THEIR AFFILIATES BE LIABLE FOR
SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, NEGLIGENCE, STRICT LIABILITY, TORT OR ANY OTHER LEGAL THEORY, and excluding any claims of Third Parties for such damages that are subject to an
indemnification obligation under Section 4.6; provided, nothing in this Section 9.1 is intended to limit Bioventus’ payment obligations under Article 3. Notwithstanding anything to contrary herein or in the New US License
Agreement, neither Party shall have any liability under this Agreement for an indemnification claim or other matter to the extent that such claim or other matter was satisfied under the New US License Agreement. 

 

	9.2	 Force Majeure. Without limiting Q-Med’s obligations under
Section 2.2(b), Section 2.5 and Section 6.2 hereof, Q-Med shall not be liable for loss, damage, detention, or delay, nor be deemed to be in default, from causes beyond its reasonable control or
from epidemics, floods, typhoons, or any other weather condition that shall be unusually severe, earthquakes, explosions, fires, wars (declared or not), war-like situations, blockades, embargoes, revolutions,
riots, insurrections, any extended interruption of public transportation, civil commotion, strikes, lockouts, acts of God or nature, changes in law or governmental regulations, or expropriation or other similar governmental action, inability to
obtain necessary materials or manufacturing facilities from usual sources or from defects or delays in the performance of its suppliers or subcontractors due to any of the foregoing enumerated causes (each a “Force Majeure”).
In the event of delay due to any such cause, the date of delivery shall be adjusted as may be reasonably necessary, but in no event more than [***] ([***]) days. In addition and without limiting the other rights, remedies and
obligations set forth this Agreement, Bioventus may cancel any order, in whole or in part, which cannot be completed due to any of the foregoing causes within [***] ([***]) days after the delivery date specified in the order.

  
 21 

	9.3	 Choice of Law. This Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of New York, without regard to conflict of laws principles, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.

  

	9.4	 Arbitration. Any dispute arising out of or in connection with, or relating to, this Agreement, or the
breach, termination, or invalidity hereof, including claims of fraud in the inducement, shall be resolved as follows. In the event of a dispute between the Parties, either Party may initiate the dispute resolution procedures of this Section 9.4
by providing written notice (the “Notice of Claim”) to the other Party identifying the dispute and stating the desire to resolve the dispute. After receiving the Notice of Claim, respondent will respond in writing within
[***] ([***]) calendar days by stating its position and setting forth a proposed resolution of the dispute. If claimant and respondent are not able to resolve the dispute within [***] ([***]) calendar days after the date
of such response, the matter in dispute shall be settled by arbitration administered by the American Arbitration Association (the “AAA”) under its Commercial Arbitration Rules, and judgment on the award rendered by the arbitrator(s)
may be entered in any court having jurisdiction thereof. The Parties hereby irrevocably and unconditionally submit to the jurisdiction of the AAA for the purposes of such proceeding, and any counterclaims that relate in any respect to this Agreement
thereafter asserted by a Party to such proceedings. The arbitral tribunal shall be comprised of three arbitrators with relevant expertise in the subject matter of the dispute. The arbitrators shall have the full authority, consistent with New York
law, to consider granting non-monetary relief, including, but not limited to, rescission, termination, declaratory judgment, or any form of equitable relief recognized under New York law. A Party may pursue
both non-monetary and monetary relief without regard to election of remedies, but may not be granted inconsistent or duplicative remedies. The place of arbitration shall be [***]. The language to be
used in the arbitral proceedings shall be English. The Parties agree that the losing Party shall bear the cost of the arbitration filing and hearing fees, the cost of the arbitrators and the AAA administrative expenses and the attorney’s fees
and reasonable associated costs and expenses of each Party. The Parties agree to reasonable document discovery provided the requesting Party makes a showing of relevance and need to the tribunal. 

 

	9.5	 Assignment. Neither this Agreement nor any of the rights and obligations arising hereunder may be
assigned or transferred by either Party without the prior written consent of the other. Such consent will not be unreasonably withheld or delayed. Notwithstanding the foregoing, (a) either Party may assign this Agreement without the consent of
the other Party to any Affiliate of such Party; provided, that such Affiliate assumes such assignment in writing to the other Party and the assigning Party shall remain joint and severally liable with such Affiliate for all of its obligations under
this Agreement; and (b) Bioventus may assign or transfer this Agreement without the consent of Q-Med to any entity that acquires substantially all of the assets of the business to which this Agreement
relates, or in the event of a change of control of Bioventus. 

  
 22 

	9.6	 Insolvency. To the extent permitted under applicable law: (a) the validity of this Agreement
shall not be affected by any proceeding under a law relating to insolvency or adjustment of debt; (b) this Agreement shall not be subject to termination on the basis that any Party becomes a party to any insolvency proceeding or one that
contemplates the adjustment of debt; and (c) if Q-Med becomes a debtor in a proceeding under a law relating to insolvency or adjustment of debt, Bioventus may retain its rights with respect to the Q-Med IP under this Agreement for the duration of the Term and may offset against any royalty or other payment obligations the amount of any damages caused by nonperformance of any of
Q-Med’s obligations under this Agreement 

  

	9.7	 Notices. Any notice to be given by one Party to the other shall be in writing and shall be deemed
given when delivered personally, mailed by certified or registered mail, postage prepaid or sent by reputable international courier (such mailed notice to be effective on the date which is [***] business days after the date of mailing), or
sent by facsimile (such facsimile notice to be effective upon receipt of confirmation (a) on the date so confirmed if prior to 5 p.m. local time on a local Business Day, or (b) if not so confirmed prior to 5 p.m. local time on a local
Business Day, the following Business Day), and addressed as follows (or to such other address as a Party may designate as to itself by written notice to the other Party): 

If to Q-Med: 

Q-Med AB 

Seminariegatan 21 

752 28 Uppsala, Sweden 

Attention:  

Telephone No.:  

Facsimile No.:  

If to Guarantor: 

Nestlé Skin Health S.A. 

Avenue Gratta-Paille 2 

Lausanne, Vaud 

Switzerland 

Attention:  

Telephone:  

Facsimile:  

If to Bioventus: 

Bioventus LLC 

4721 Emperor Blvd. Suite 100 

Durham, NC 27703 

Attn.  

With a copy to 

Bioventus LLC 

4721 Emperor Blvd. Suite 100 

Durham, NC 27703 

Attn.  

  
 23 

	9.8	 Amendment. This Agreement may be modified or amended only by written agreement of the Parties
hereto signed by authorized representatives of the Parties hereto and specifically referencing this Agreement. 

  

	9.9	 Entire Agreement. 

 

	(a)	 This Agreement, together with the New US License Agreement, the Quality Agreement and the New Nasha Amended
License Agreement, each of their appendices, exhibits, schedules and certificates, and all documents and certificates delivered or contemplated in connection herewith and therewith constitute the entire agreement between the Parties with respect to
the subject matter hereof and supersede all prior agreements or understandings of the Parties relating thereto. 

  

	(b)	 Upon the Amendment Effective Date, the Current US Supply Agreement shall be terminated and replaced in its
entirety with this Agreement. 

  

	9.10	 Severability. Whenever possible, each provision of this Agreement will be interpreted in such
manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by, invalid or unenforceable under applicable law, such provision will be ineffective only to the extent of such prohibition,
invalidity or enforceability, without invalidating the remainder of this Agreement and the Parties shall in good faith seek to agree on an alternative provision reflecting the intent of the Parties that is enforceable. 

 

	9.11	 Expenses. Except as set forth in this Agreement, Q-Med
and Bioventus will each bear their own expenses and the expenses of their respective Affiliates incurred in connection with the negotiation and preparation of this Agreement. 

 

	9.12	 Further Actions. Q-Med and Bioventus each hereby agrees
to use all reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary or proper and execute and deliver such documents and other papers as may be required to make effective the transactions
contemplated by this Agreement. 

  

	9.13	 Waiver. Any term or provision of this Agreement may be waived at any time by the Party entitled
to the benefit thereof only by a written instrument executed by such Party. No delay on the part of Q-Med or Bioventus in exercising any right, power or privilege hereunder will operate as a waiver thereof,
nor will any waiver on the part of either Q-Med or Bioventus of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor will any single or partial
exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. 

 

	9.14	 Relationship of the Parties. The Parties shall each be an independent contractor in the
performance of their respective obligations hereunder, and, the provisions hereof are not intended to create any partnership, joint venture, agency or employment relationship between the Parties. Each Party shall be responsible for and shall comply
with all state, local, federal and foreign laws pertaining to employment taxes, income withholding and other employment related statutes applicable to that Party. Except as is expressly set forth herein, neither Party will have any right by virtue
of this Agreement to bind the other Party in any manner whatsoever. 

  
 24 

	9.15	 No Third Party Rights. No provision of this Agreement will be deemed or construed in any way to
result in the creation of any rights or obligations in any Person not a Party to this Agreement. 

  

	9.16	 Construction. This Agreement will be deemed to have been drafted by both Q-Med and Bioventus and will not be construed against either Party as the draftsperson hereof. 

  

	9.17	 Enforcement. The Parties agree that irreparable damage would occur in the event that any of the
provisions of this Agreement were not performed in accordance with their specific terms. It is accordingly agreed that the Parties shall be entitled to specific performance of the terms of this Agreement, this being in addition to any other remedy
to which they are entitled at law or in equity. 

  

	9.18	 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be
deemed an original, and all of which shall constitute one and the same agreement. 

  

	9.19	 Headings. The heading references herein are for convenience purposes only, do not constitute a
part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof. 

  

	9.20	 Appendices, Exhibits, Schedules and Certificates. Each appendix, exhibit, schedule
and certificate attached hereto is incorporated herein by reference and made a part of this Agreement. 

 [Signatures
Follow] 

  
 25 

 IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the day and year first above
written. 
  

			
	Q- MED AB
		
	By:	 	 /s/ Christian Matton

		 	Name: Christian Matton
		 	Title: Chairman of the Board
	
	NESTLÉ SKIN HEALTH S.A. in its capacity as Guarantor
		
	By:	 	 /s/ Stuart Raetzman

		 	Name: Stuart Raetzman
		 	Title: Member of the Board
	
	BIOVENTUS LLC
		
	By:	 	 /s/ Anthony P. Bihl III

		 	Name: Anthony P. Bihl III
		 	Title: CEO

 SCHEDULE A 

QUALITY AGREEMENT 

 SCHEDULE B 

SPECIFICATIONS 
  

	1.	 Licensed Product specification 

Durolane®, Art. No: TBD 

[***]EX-10.10

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10).
Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. 
 Exhibit 10.10

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 

Execution Copy 

EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

by and between 
 IBSA
INSTITUT BIOCHIMIQUE SA (SWITZERLAND) 
 and 

BIOVENTUS LLC (UNITED STATES OF AMERICA) 

HYALURONIC ACID INTRA-ARTICULAR INJECTION 

GEL-SYN-3TM
 
  

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

 Table of Contents 
  

							
	 Art. I.
	 	DEFINITIONS	  	 	4	 
	 Art. II.
	 	GRANT	  	 	6	 
	 Art. III.
	 	DISTRIBUTION LICENSE FEE	  	 	6	 
	 Art. IV.
	 	OWNERSHIP OF THE REGISTRATION FILE	  	 	7	 
	 Art. V.
	 	DISCLOSURE OF SCIENTIFIC AND TECHNICAL INFORMATION - CONFIDENTIALITY	  	 	7	 
	 Art. VI.
	 	FDA APPROVAL	  	 	8	 
	 Art. VII.
	 	MARKETING OF THE PRODUCT	  	 	9	 
	 Art. VIII.
	 	INTELLECTUAL PROPERTY RIGHTS	  	 	9	 
	 Art. IX.
	 	QUALITY AND QUALITY ASSURANCE	  	 	10	 
	 Art. X.
	 	PHARMACOVIGILANCE OF THE PRODUCTS	  	 	11	 
	 Art. XI.
	 	INDEMNIFICATIONS	  	 	11	 
	 Art. XII.
	 	Art. XII SALES FORECAST AND PURCHASE ORDERS	  	 	12	 
	 Art. XIII.
	 	TRANSFER PRICE	  	 	13	 
	 Art. XIV.
	 	PAYMENT TERMS	  	 	13	 
	 Art. XV.
	 	SHIPPING TERMS	  	 	14	 
	 Art. XVI.
	 	MINIMUM PURCHASE REQUIREMENT	  	 	14	 
	 Art. XVII.
	 	TERMINATION	  	 	15	 
	 Art. XVIII.
	 	RIGHTS AND DUTIES AFTER TERMINATION	  	 	15	 
	 Art. XIX.
	 	CHANGE OF SHAREHOLDING CONTROL	  	 	16	 
	 Art. XX.
	 	JURISDICTION	  	 	16	 
	 Art. XXI.
	 	Art. XXI MISCELLANEOUS	  	 	17	 
	 Art. XXII.
	 	NOTICES	  	 	18	 
	 Annex A. SPECIFICATIONS OF THE PRODUCT
	  	 	20	 
	 Annex B. TRADEMARKS
	  	 	21	 
	 Annex C. SDEA
	  	 	22	 
	 Annex D. TRANSFER PRICES
	  	 	35	 

  
 2 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

between 
 IBSA INSTITUT
BIOCHIMIQUE SA (SWITZERLAND) 
 a Swiss organization incorporated in accordance with the laws of Switzerland and having its registered
office at 
 Via al Ponte 13, 6900 Massagno – Switzerland 

e mail: 
 (hereinafter,
“IBSA”) 
 and 

BIOVENTUS LLC (UNITED STATES OF AMERICA) 

a limited liability company incorporated and existing under the laws of State of Delaware, United States of America and having its registered
office at 
 4721 Emperor Blvd., Suite 100, Durham, NC 27703, USA 

e mail: 
 (hereinafter,
“BIOVENTUS”) 
 IBSA and BIOVENTUS each are referred to herein as a “Party,” and collectively, as the
“Parties.” 
 WHEREAS 

IBSA is a company engaged in the production and marketing of pharmaceutical products/medical devices and owns patents, know-how and trademarks concerning said pharmaceutical products; 
 IBSA owns all rights for production
and distribution of the PRODUCT, as defined below, and is free to grant a license thereunder; 
 BIOVENTUS after thorough evaluation of the
existing documentation made available by IBSA wishes to obtain the license and the right to promote, market, distribute and sell the PRODUCT in the TERRITORY all on the terms and subject to the conditions of this Agreement; and 

IBSA and BIOVENTUS hereby agree that this Preamble will be an integral part of this Agreement, having the same force and effect as the other
provisions contained in this Agreement, and that accordingly the relevant terms used in this Preamble shall have the meaning defined under Art. I (“DEFINITIONS”) of this Agreement. 

NOW, THEREFORE, in consideration of the mutual covenants herein contained, the Parties hereto agree as follows: 

  
 3 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	Art. I.	 DEFINITIONS 

For all purposes of this Agreement the terms defined in this Article I shall have the following meaning. 

 

	 	I.1	 “AFFILIATES” shall mean, with respect to any person or entity, another person or entity that
controls, is controlled by or is under common control with the applicable person or entity. 

  

	 	I.2	 “AUTHORIZED DISTRIBUTOR” means a BIOVENTUS AFFILIATE or a third party that either (i) is
directly or indirectly controlled by BIOVENTUS or (ii) is approved by IBSA to act as BIOVENTUS’s distributor of the PRODUCT, such approval not to be unreasonably withheld, conditioned or delayed. 

 

	 	I.3	 “CONFIDENTIAL INFORMATION” shall mean any and all proprietary regulatory, technical,
manufacturing, business, financial, operational, administrative, marketing or economic information, data, documents, designs, patents, materials, product samples and KNOW-HOW (as defined below), as well as any
and all written information and documents of whatsoever kind marked, in any language, as confidential or proprietary or secret, in each case pertaining to IBSA or to BIOVENTUS, as the case may be, and disclosed by either Party to the other Party,
whether orally or in writing or in whatsoever other form, in connection with the present or potential cooperation between the Parties contemplated by this Agreement. 

 

	 	I.4	 “EFFECTIVE DATE” shall mean the date of the last signature of this Agreement.

  

	 	I.5	 “FIRST MARKETING YEAR” shall mean the first complete twelve-month period (from January to
December) subsequent to the LAUNCH DATE of the PRODUCT in the TERRITORY by BIOVENTUS (for the sake of clarity, the PRODUCT be launched in August 2016, the FIRST MARKETING YEAR will be January 1 – December 31, 2017 and the MINIMUM
PURCHASE REQUIREMENT shall become applicable starting from January 1, 2017). “SECOND MARKETING YEAR” shall mean the twelve-month period commencing from the end of the FIRST MARKETING YEAR and so on. 

 

	 	I.6	 “HEALTH AUTHORITIES” shall mean the competent National Health Authorities in the TERRITORY.

  

	 	I.7	 “KNOW-HOW” shall mean all secret scientific and
technical information, trade secrets and data owned by IBSA or any of its AFFILIATES relating to the PRODUCT, including all confidential technico-analytical, pharmacological, preclinical and clinical data, literature, bulletins and other pertinent
information related thereto, and which may be useful to BIOVENTUS in marketing and selling the PRODUCT and/or in maintaining and in filing any necessary governmental authorizations to sell the PRODUCT. 

 

	 	I.8	 “LAUNCH DATE” shall mean the date of the first commercial sale in an arm’s length
transaction of the PRODUCT in the TERRITORY. 

  

	 	I.9	 “FAILURE TO SUPPLY” means any consecutive [***] months period after any required
delivery date in accordance with Section XII.2 during which IBSA has not timely delivered to BIOVENTUS at least [***] of the quantities of PRODUCT ordered in compliance with Article XII hereof, provided that
non-delivery by reason of FORCE MAJEURE shall not be a FAILURE TO SUPPLY. 

  
 4 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	 	I.10	 “FDA APPROVAL” shall mean the FDA approval for the premarket approval application (PMA)
[***] or [***] PRODUCT granted to Ibsa Farmaceutici Italia srl and licensed to IBSA Institut Biochimique SA. 

  

	 	I.11	 “GAAP” shall mean U.S. generally accepted accounting principles as in effect at the relevant
time or for the relevant period, applied on a consistent basis during the period involved. 

  

	 	I.12	 “MINIMUM PURCHASE REQUIREMENT” shall have the meaning set forth in Art. XVI.l below.

  

	 	I.13	 “NET SELLING PRICE” shall mean the gross amount invoiced by BIOVENTUS (or by its AUTHORIZED
DISTRIBUTOR, in cases where the AUTHORIZED DISTRIBUTOR is selling the PRODUCT) for sales of PRODUCT under this Agreement, minus any and all deductions actually taken by BIOVENTUS or the AUTHORIZED DISTRIBUTOR with respect to such sales in
accordance with GAAP, including, but not limited to, deductions for: 

 (i) trade, quantity prompt pay and cash discounts,
coupons, rebates and other price reductions for the PRODUCT; 
 (ii) credits and allowances for rejection or return of PRODUCT previously
sold, bad debts, price protection and shelf stock adjustments; reprocurement charges and other similar charges and administrative, data and inventory management fees; and 

(iii) rebates and chargebacks, including, but not limited to, any payments required by law to be made under Medicaid, Medicare or other
government medical assistance programs. 
 It is understood that the deductions may not exceed [***] percent ([***]%) of the
gross amount. 
 Notwithstanding anything to the contrary, the transfer of a PRODUCT shall not be considered a sale of a PRODUCT under this
Agreement to the extent such transfer (i) is in connection with the research, development or testing of a PRODUCT or (ii) is for sample purposes. 
  

	 	I.14	 “PRODUCT” shall mean the device described in Annex A to this Agreement. 

 

	 	I.15	 “PRODUCT COMPETITOR” means any company that markets a hyaluronic acid product (other than the
PRODUCT) in the TERRITORY for the indications set forth in the PMA for the PRODUCT. 

  

	 	I.16	 “REGISTRATION FILE” shall mean all the information, including regulatory, technical and
clinical data, concerning the PRODUCT (including, but not limited to, all such information on which the FDA APPROVAL is based). 

  
 5 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	 	I.17	 “CHANGE OF SHAREHOLDING CONTROL” shall mean the purchase or other acquisition by a third party
after the EFFECTIVE DATE of more than 50% of the voting securities of the other Party; provided however, the sale of some or all of the voting securities of a Party through one or more public offerings of registered securities shall not constitute a
CHANGE OF SHAREHOLDING CONTROL, so long as no single purchaser of the voting securities acquires more than 50% of the voting securities of the other Party in such public offerings. 

 

	 	I.18	 “TERRITORY” shall mean the [***]. 

 

	 	I.19	 “TRADEMARKS” shall mean the trademark indicated in Annex B to this Agreement.

  

	Art. II.	 GRANT 

  

	 	II.1	 IBSA hereby: 

(i) grants to BIOVENTUS and its AFFILIATES, and BIOVENTUS hereby accepts from IBSA, upon and subject to all terms and conditions of this
Agreement, the exclusive (even as to IBSA and its AFFILIATES) right to import, promote, market, distribute, offer for sale and sell the PRODUCT in the TERRITORY; and 

(ii) assigns to BIOVENTUS, and BIOVENTUS accepts from IBSA, all right, title and interest in and to the TRADEMARK (including any goodwill
related thereto). 
 Concurrently with the execution of this Agreement, the Parties are executing a Trademark Assignment deed in the form
required by BIOVENTUS to register the assignment at the US Patent and Trademark Office. 
  

	 	II.2	 IBSA hereby appoints BIOVENTUS, and BIOVENTUS hereby accepts appointment as IBSA’s exclusive distributor
of the PRODUCT in the TERRITORY and IBSA agrees not to market, sell or distribute the PRODUCT in the TERRITORY to or for the benefit of any person or entity other than BIOVENTUS, its AFFILIATES or AUTHORIZED DISTRIBUTORS. IBSA will use its best
efforts to prevent any third parties from selling PRODUCT in the TERRITORY, including in cases where such third parties import the PRODUCT from outside the TERRITORY. 

 

	 	II.3	 Except in the event of a FAILURE TO SUPPLY (as defined in Article XVI.3 below), BIOVENTUS agrees to purchase
all of its requirements for the promotion and sale of the PRODUCT in the TERRITORY from IBSA on an exclusive basis for the entire duration of this Agreement. Except as set forth in Article XXI.3, BIOVENTUS shall not grant to third parties any of the
rights under Paragraph II.1 above, other than to an AFFILIATE or any AUTHORIZED DISTRIBUTOR. 

  

	Art. III.	 DISTRIBUTION LICENSE FEE 

 

	 	III.1	 As a consideration for the exclusive rights granted under Paragraph II.1 above, BIOVENTUS shall pay to IBSA a
fee amounting to US$ [***] (in words, U.S. Dollars [***]) payable upon the EFFECTIVE DATE. 

  
 6 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	 	III.2	 It is understood that the above-mentioned amounts are net from any applicable transfer tax in the TERRITORY.

  

	Art.IV.	 OWNERSHIP OF THE REGISTRATION FILE 

 

	 	IV.1	 The REGISTRATION FILE shall always remain property of IBSA or of any third party designated by IBSA (provided
that such third party agrees to be bound by the provisions of this Agreement to the same extent as IBSA is bound). IBSA will provide BIOVENTUS with prompt notice of any changes made to the REGISTRATION FILE during the term of this Agreement. It is
understood that any person or entity appointed by IBSA to participate in the manufacturing process or in the analytical control must be included in the REGISTRATION FILE and authorized by the HEALTH AUTHORITIES. 

 

	Art. V.	 DISCLOSURE OF SCIENTIFIC AND TECHNICAL INFORMATION – CONFIDENTIALITY 

 

	 	V.1	 In relation to the Confidential Information disclosed by one Party to the other, each Party agrees:

  

	 	A.	 not to publish or provide or make available any of the other Party’s Confidential Information in any form
to any third party (except as provided in Article V.2 below); 

  

	 	B.	 not to use or reproduce any of the other Party’s Confidential Information except for use reasonably
necessary for the performance of this Agreement. 

  

	 	V.2	 Each Party may provide or make available the Confidential Information disclosed by the other:

  

	 	A.	 to those of its employees, agents, contractors (including, in the case of BIOVENTUS, any AUTHORIZED
DISTRIBUTORS) or representatives who have a need to know consistent with the receiving Party’s authorized use of that Confidential Information; 

  

	 	B.	 to its AFFILIATES, in order to perform this Agreement, in which event the recipients of the Confidential
Information shall be bound by obligations of confidentiality no less onerous than those contained in this clause; and 

  

	 	C.	 to any existing or potential investors, financing sources or acquirers and their respective advisors, in each
case who are subject to an obligation of confidentiality. 

  

	 	V.3	 The obligations of confidentiality and non-use set forth under
Paragraph V.l above shall not apply to any part of the Confidential Information which: 

  

	 	A.	 is in or comes into the public domain in any way without breach of this Agreement by the receiving Party;

  
 7 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	 	B.	 the receiving Party can show it was in its possession or known to it by being in its use or being recorded in
its files or computers or other recording media prior to receipt from the disclosing Party and was not previously acquired by the receiving Party from the disclosing Party under an obligation of confidentiality; 

 

	 	C.	 is independently developed by the receiving Party, without use of the disclosing Party’s Confidential
Information; 

  

	 	D.	 is provided to the receiving Party by a third party who, to the receiving Party’s knowledge, is not
subject to any confidentiality obligation to the disclosing Party; or 

  

	 	E.	 is disclosed by the receiving Party (i) with the prior written consent of the disclosing Party or
(ii) without such consent, after a period of 10 (ten) years from the date of termination of this Agreement. 

  

	 	V.4	 Notwithstanding the foregoing, the receiving Party shall be entitled to make any disclosure required by law or
by any governmental authority of the other Party’s Confidential Information provided that it gives the other Party not less than [***] working days’ notice of such disclosure. 

 

	 	V.5	 Except as otherwise required by law, the Parties agree not to disclose the terms of this Agreement to third
parties, other than their respective AFFILIATES, representatives and agents (and/or any existing or potential investors, financing sources or acquirers and their respective advisors, in each case who are subject to an obligation of confidentiality).
Neither shall make any announcement in relation to or otherwise advertise its contents without the prior written consent of the other Party)’. Any press releases by a Party are subject to the review and approval of the other Party, which shall
not be unreasonably withheld, conditioned or delayed. 

  

	Art. VI.	 FDA APPROVAL 

  

	 	VI.1	 The FDA APPROVAL has been obtained by IBSA and has the following number: [***]. 

 

	 	VI.2	 The FDA APPROVAL shall always remain the property of IBSA or of any third party designated by IBSA.

  

	 	VI.3	 For the entire duration of this Agreement IBSA shall use its best efforts to maintain the FDA approval valid
and effective at its own cost and in accordance with all applicable regulations in the TERRITORY. 

 BIOVENTUS undertakes
to reasonably assist IBSA (to the extent BIOVENTUS’s assistance is necessary) at no cost in all regulatory activities related to the maintenance of the FDA APPROVAL in the TERRITORY; provided, however, that BIOVENTUS shall not be
required to incur any out-of-pocket expenses in providing such assistance unless IBSA agrees to reimburse BIOVENTUS for such expenses. 

  
 8 

 EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC 
  

	Art. VII.	 MARKETING OF THE PRODUCT 

 

	 	VII.1	 BIOVENTUS undertakes to use commercially reasonable efforts to launch the PRODUCT in the United States within
[***] months from EFFECTIVE DATE. 

  

	 	VII.2	 In marketing the PRODUCT, BIOVENTUS shall exercise the same diligence, which BIOVENTUS employs in marketing its
own products of similar market potential, taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, profitability, and other
relevant factors commonly considered in similar circumstances. 

  

	 	VII.3	 The PRODUCT shall be promoted in accordance with the therapeutic indications set forth in the FDA APPROVAL, as
well as in compliance with any applicable law and regulation in force in the TERRITORY. 

  

	 	VII.4	 Except for the PRODUCT, BIOVENTUS agrees not to actively promote in the TERRITORY, either directly or
indirectly, any intra-articular hyaluronan injection classified as [***] according to WHO/ATC classification and having the same marketing positioning as the PRODUCT, without IBSA’s prior written consent. 

 

	 	VII.5	 The foregoing restrictions set forth in Paragraph VII.4 shall not apply to products already marketed in the
TERRITORY by BIOVENTUS at EFFECTIVE DATE or to BIOVENTUS’ promotion and sale in the TERRITORY of a single injection intra-articular hyaluronan injection for osteoarthritis during the term of this Agreement. 

 

	 	VII.6	 IBSA will not (and will ensure that its AFFILIATES do not) actively promote in the TERRITORY (or license or
otherwise permit any third party to promote in the TERRITORY), either directly or indirectly, any intra-articular hyaluronan injection classified as [***] according to WHO/ATC classification. 

 

	 	VII.7	 Any promotional and marketing costs and expenses incurred by BIOVENTUS with respect to the PRODUCT in the
TERRITORY shall be borne by BIOVENTUS. 

  

	 	VII.8	 BIOVENTUS shall comply with all applicable legal and regulatory requirements with respect to promotional
materials, advertising and any other material relating to the PRODUCT. Copies of all promotional materials, advertising and any other material relating to the PRODUCT, shall be submitted to IBSA. 

 

	 	VII.9	 At IBSA’s request BIOVENTUS undertakes to provide IBSA with a sales report containing such information
relating to sales of the PRODUCT in the TERRITORY as necessary to calculate the transfer price to be paid to IBSA for the PRODUCT pursuant to Annex D. 

  

	Art. VIII.	 INTELLECTUAL PROPERTY RIGHTS 

 

	 	VIII.1	 BIOVENTUS undertakes not to have registered and/or use in and outside the TERRITORY any marks or signs that are
confusingly similar in respect of sound, appearance or meaning to the TRADEMARKS. 

  

	 	VIII.2	 BIOVENTUS shall at its own costs and expense maintain the TRADEMARKS in force in the United States.

  
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	 	VIII.3	 BIOVENTUS acknowledges that all the KNOW-HOW and/or documentation
pertaining to the PRODUCT, as well as the relevant rights of exploitation thereof, are exclusive property of IBSA. 

  

	Art. IX.	 QUALITY AND QUALITY ASSURANCE 

 

	 	IX.1	 IBSA shall supply the PRODUCT containing the substance in accordance with GMP manufacturing standards and
within the technical specifications that is part of the REGISTRATION FILE. Any change by IBSA in a supplier of critical element of the PRODUCT is subject to BIOVENTUS’ prior review and approval, which shall not be unreasonably withheld,
conditioned or delayed. 

 A Quality Agreement (the “Quality Agreement”) will be separately signed by the
Parties. The Parties will use good faith efforts to negotiate and execute the Quality Agreement within [***] days after the EFFECTIVE DATE. 
  

	 	IX.2	 BIOVENTUS shall promptly inspect any quantity of PRODUCT received from IBSA at BIOVENTUS’s distribution
center in the United States, in order to identify any breakage or shortage of material that is apparent from a visual inspection of the outer packaging of the shipment (“OBVIOUS DEFECTS”) and shall promptly inform IBSA.

 In the event of any justified claim for defective, or missing PRODUCT, and upon condition that such a claim has been
reported to IBSA (A) with respect to OBVIOUS DEFECTS, within [***] working days from the date of arrival at BIOVENTUS’s distribution center in the United States or (B) with respect to any other defects, promptly after discovery
by BIOVENTUS; in each case, together with reasonable evidence of the claim, IBSA shall, free of charge, make the maximum effort to replace such defective or missing PRODUCT within the earliest possible time. For the purposes hereof,
“defective” PRODUCTS include any PRODUCT that does not conform to the requirements in Article IX.3 below. 
  

	 	IX.3	 IBSA shall ensure that all PRODUCT supplied hereunder, prior to delivery to BIOVENTUS, has been manufactured,
packaged, tested, stored and handled: (i) at facilities which are approved by the FDA and any other relevant HEALTH AUTHORITY and (ii) in a manner consistent with industry standards and in accordance with applicable laws, rules and
regulations in the TERRITORY, including but not limited to the FDA’s then-current Good Manufacturing Practices applicable to the manufacture of medical devices and pharmaceutical products for human use in the United States, as provided in the
FDA’s guidance documents (“cGMP”) and in accordance with the specifications indicated in the REGISTRATION FILE as submitted to the HEALTH AUTHORITIES, the specifications set forth on Annex A and the provisions of the Quality
Agreement. IBSA warrants that all PRODUCT when delivered to BIOVENTUS will not be adulterated or misbranded under the United States Food, Drug and Cosmetics Act and will have remaining expiry dating of at least [***] months from the date of
receipt of the PRODUCT at BIOVENTUS’s U.S. distribution facility. 

  

	 	IX.4	 IBSA shall also bear the costs for freight, insurance, customs, etc., incurred for PRODUCT, which must be
replaced to BIOVENTUS and for those batches of PRODUCT to be returned to IBSA, or destroyed by BIOVENTUS, as IBSA may choose. 

  
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	 	IX.5	 The replaced PRODUCT must comply with the specifications indicated in the REGISTRATION FILE and the other
requirements set forth in Article IX.3. 

  

	Art. X.	 PHARMACOVIGILANCE OF THE PRODUCTS 

 

	 	X.1	 The Parties shall sign the Pharmacovigilance Agreement provided in Annex C to this Agreement.

  

	Art. XI.	 INDEMNIFICATIONS 

 

	 	XI.1	 IBSA shall indemnify, defend and hold BIOVENTUS, its AFFILIATES, and any of the foregoing’s respective
directors, officers, employees, agents, and other representatives (each of the foregoing, a “Bioventus Indemnitee”) harmless from and against all direct damages, liabilities, expenses and/or losses (collectively,
“Losses”), arising from any third party claim, demand, suit, action or proceeding (a “Third Party Claim”) arising out of (a) the supply under this Agreement of any PRODUCT that does not conform to the
specifications set forth in Annex A, (b) IBSA’s breach of this Agreement, (c) IBSA’s gross negligence or willful misconduct, (d) IBSA’s failure to comply with applicable law or GMP, or (e) a claim by a Third Party
that (x) IBSA’s performance of any obligations under this Agreement or the manufacture, sale, import, export, or other commercialization of PRODUCT or (y) any Bioventus Indemnitee’s use, sale, import, or export of any Products
constitutes, in the case of (x) or (y), infringement or misappropriation of a Third Party’s intellectual property rights. The foregoing indemnification obligations shall not apply to the extent a Third Party Claim or Loss is a result of
(i) BIOVENTUS, or its Affiliates’ failure to comply with applicable law or (ii) BIOVENTUS’ gross negligence or willful misconduct. 

  

	 	XI.2	 BIOVENTUS shall indemnify, defend and hold IBSA and its Affiliates’ directors, officers, employees,
agents, and other representatives (each of the foregoing, an “IBSA Indemnitee”) harmless from and against all Losses arising from any Third Party Claim to the extent arising out of (a) BIOVENTUS’ failure to comply with
applicable law with respect to the performance of this Agreement, or (b) BIOVENTUS’ gross negligence or willful misconduct (c) BIOVENTUS’ improper handling, storage, distribution, sale of the PRODUCT (other than any PRODUCT that
does not conform to the requirements set forth in Article IX.3), (d) BIOVENTUS’ use of the KNOW-HOW disclosed by IBSA in violation of this Agreement or (e) any of BIOVENTUS’s marketing materials
about the PRODUCT to the extent such marketing materials are inconsistent with the label approved by the relevant HEALTH AUTHORITIES. 

  

	 	XI.3	 IN NO EVENT SHALL ANY PARTY OR ANY OF ITS AFFILIATES BE LIABLE TO ANY OTHER PARTY OR ANY AFFILIATE THEREOF FOR
ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION Of CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT, PROVIDED THAT,
NOTWITHSTANDING ANYTHING TO THE CONTRARY, THE FOREGOING SHALL NOT BE CONSTRUED TO LIMIT THE INDEMNITY OBLIGATIONS SET FORTH IN SECTION XI.1 AND XI.2 ABOVE OR EITHER PARTY’S LIABILITY FOR PATENT INFRINGEMENT. 

  
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	 	XI.4	 The foregoing indemnification obligations shall not apply to the extent a particular Third Party Claim or Loss
is a result of the circumstances described in clauses (a), (b), (c), (d) or (e) of Article XI.1. Each Party’s agreement to indemnify, defend, and hold harmless under Article XI.1 or XI.2, as applicable, is conditioned upon the indemnified
party (a) providing written notice to the indemnifying Party of any claim, demand or action as soon as reasonably possible, and in any event no later than within [***] days after the indemnified party has actual knowledge of such claim,
demand or action, (b) permitting the indemnifying Party to assume control over the investigation of, preparation and defense against, and settlement or voluntary disposition of any such claim, demand or action, using legal counsel selected by
the indemnifying Party and reasonably acceptable to the indemnified party, (c) assisting the indemnifying Party, as reasonably requested by the indemnifying Party and at the indemnifying Party’s reasonable expense, in the investigation,
preparation, defense, and settlement or voluntary disposition of any such claim, demand or action, (d) not compromising, settling, or entering into any voluntary disposition of any such claim, demand or action without the indemnifying
Party’s prior written consent, which consent shall not be unreasonably withheld, and (e) furnishing promptly to the indemnifying Party copies of all notices and documents (including court papers) received by any indemnified party in
connection with the Claim for which indemnification is being sought; provided, however, that, if the party entitled to indemnification hereunder fails to comply with any of the foregoing conditions, the indemnifying Party will only be relieved of
its indemnification obligation under this Agreement to the extent materially prejudiced by such failure, hi no event may the indemnifying Party compromise, settle, or enter into any voluntary disposition of any claim, demand or action in any manner
that admits material fault or wrongdoing on the part of the indemnified party or incurs non- indemnified liability on the part of the indemnified party without the prior written consent of the indemnified
party. 

  

	Art. XII.	 SALES FORECAST AND PURCHASE ORDERS 

 

	 	XII.1	 BIOVENTUS agrees to place orders for the following minimum quantities of each licensed PRODUCT (minimum
standard batches): 

 [***] prefilled syringes 

 

	 	XII.2	 Within the month of September of each calendar year, BIOVENTUS shall inform IBSA of its estimate of purchase
requirements for the following year. At the beginning of each quarter, BIOVENTUS shall provide an updated rolling forecast for the year. BIOVENTUS shall issue purchase orders at least [***] months before the required delivery date as usual
procedure and [***] months before the required delivery date as far as the first order is concerned or in case of any modification needed in packaging material. All orders will have to be confirmed in writing by IBSA, within [***]
working days from receipt. 

  

	 	XII.3	 In the event that BIOVENTUS’s orders exceed the forecast, IBSA shall not be responsible for
delivering quantities in excess of [***] (percent), more than the applicable quarterly purchase forecast. 

  
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	 	XII.4	 Since packaging material is customized for the TERRITORY market, all costs relating to the costs of destruction
of the remaining stock of packaging material, resulting from a change instigated by BIOVENTUS, are to be invoiced to BIOVENTUS. 

  

	Art. XIII.	 TRANSFER PRICE 

 

	 	XIII.1	 IBSA will supply the PRODUCT to BIOVENTUS in accordance with the prices and conditions as stated in Annex D to
this Agreement. IBSA will supply all PRODUCT in finished form, in final packaging. 

  

	 	XIII.2	 Any FLOOR PRICE increases will only be possible by written agreement between the Parties.

  

	 	XIII.3	 The initial FLOOR PRICE is stated in Annex D to this Agreement and unless unexpected circumstances occur shall
not be reviewed during the first [***] MARKETING YEARS. Any increase of the FLOOR PRICE, which may take place no more often than every [***] MARKETING YEARS, will be negotiated by the Parties in good faith and such an increase will not
be more than [***] (percent) of the current applied FLOOR PRICE. 

  

	 	XIII.4	 In the event that, before or after [***] MARKETING YEARS, the prices and conditions become uneconomical
to either Party, it is agreed that the matter shall be mutually discussed in good faith in order to reach equitable acceptable conditions; provided, however, that in no event will the prices be changed unless agreed to by both Parties in writing, in
each of their sole discretions. 

  

	Art. XIV.	 PAYMENT TERMS 

 

	 	XIV.1	 IBSA will invoice BIOVENTUS at the applicable FLOOR PRICE (as defined on Annex D) for each PRODUCT shipment
(the “FLOOR PRICE PAYMENT”). Payment will be by direct bank transfer to a [***] bank payable at [***] days from invoice date. 

 

	 	XIV.2	 Within [***] days after the end of each calendar quarter (starting with the calendar quarter in which
the LAUNCH occurs): (A) BIOVENTUS will provide IBSA with a written statement of the aggregate NET SELLING PRICE received during such calendar quarter (“AGGREGATE QUARTERLY SALES”), and the quantity of PRODUCT to which such AGGREGATE
QUARTERLY SALES relates and (B) if, based on such AGGREGATE QUARTERLY SALES, the aggregate transfer price applicable to such quantity of PRODUCT (as determined pursuant to Annex D) is greater than the aggregate FLOOR PRICE PAYMENTS made to IBSA
for such quantity of PRODUCT, the BIOVENTUS will pay IBSA an amount equal to the difference between such aggregate transfer price and such aggregate FLOOR PRICE PAYMENTS. 

 

	 	XIV.3	 BIOVENTUS shall be liable for interest on any overdue payment required to be made under this Agreement,
commencing on the date such payments becomes due, at an annual rate of [***]. If such interest rate exceeds the maximum legal rate in the jurisdiction where a claim therefore is being asserted, the interest shall be reduced to such maximum
legal rate. 

  
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	Art. XV.	 SHIPPING TERMS 

 

	 	XV.1	 All shipments of PRODUCT shall be provided by IBSA ex-works IBSA
warehouse in [***]. 

  

	Art. XVI.	 MINIMUM PURCHASE REQUIREMENT 

 

	 	XVI.1	 Subject to Article XVI.3, BIOVENTUS undertakes to purchase from IBSA the following annual minimum quantities of
PRODUCT in the TERRITORY (“MINIMUM PURCHASE REQUIREMENT”): 

 1st MARKETING
YEAR:    [***] prefilled syringes 
 2nd MARKETING YEAR:    [***] prefilled syringes

 3rd MARKETING YEAR:    [***] prefilled syringes 

4th MARKETING YEAR onwards:    [***] prefilled syringes 

Sample units are not included in the MINIMUM PURCHASE REQUIREMENT. 
  

	 	XVI.2	 Should BIOVENTUS fail to meet at least [***] of the annual MINIMUM PURCHASE REQUIREMENT during any
MARKETING YEAR during the term of this Agreement (other than on account of a FAILURE TO SUPPLY (as defined in Article XVI.3), IBSA shall have the right either to ask BIOVENTUS to pay a penalty of [***]% of the FLOOR PRICE for the unpurchased
quantities or to terminate this Agreement upon [***] days prior written notice to BIOVENTUS; provided, however, that this Agreement will not terminate if BIOVENTUS, by the end of such [***] days period, has issued
purchase orders to IBSA for a quantity of PRODUCT that, when combined with the quantities previously ordered during the applicable MARKETING YEAR, equal or exceed the applicable MINIMUM PURCHASE REQUIREMENT (and, for the avoidance of doubt, such
additional purchase orders may provide for a delivery date that is in January of the following MARKETING YEAR. Therefore the purchase orders needs to be issued on or before August 30th of the concerned MARKETING YEAR). Such termination by IBSA shall
be IBSA’s sole and exclusive remedy with respect to any failure by BIOVENTUS to meet the annual MINIMUM PURCHASE REQUIREMENT, and BIOVENTUS shall have no liability to IBSA with respect to any such failure. 

Notwithstanding the foregoing, should BIOVENTUS buy [***] or more of the annual MINIMUM PURCHASE REQUIREMENT, IBSA shall only have the
right to ask BIOVENTUS to pay a penalty of [***]% of the FLOOR PRICE for the unpurchased quantities as IBSA’s sole and exclusive remedy for the BIOVENTUS’s failure to purchase the annual MINIMUM PURCHASE REQUIREMENT. 

 

	 	XVI.3	 If during any part of the MARKETING YEAR, a FAILURE TO SUPPLY occurs, the MINIMUM PURCHASE REQUIREMENT set
forth in Article XIV.1 for such MARKETING YEAR will be reduced by a percentage equal to the percentage of the MARKETING YEAR during which such FAILURE TO SUPPLY occurred. 

  
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	Art. XVII.	 TERMINATION 

  

	 	XVII.1	 The initial term of this Agreement shall commence on the EFFECTIVE DATE and shall have a duration of
[***] years. After the initial term, the Agreement will be automatically renewed for consecutive [***] year periods, unless one of the Parties gives to the other Party notice of termination at least [***] months prior to the
expiry of the initial term or any renewal term. 

  

	 	XVII.2	 Either Party may terminate this Agreement before the end of the term in the event of an uncured breach by the
other Party (i) as far as IBSA is concerned, the uncured breach of any of its obligation under Paragraphs II.l., II.2, V.l, V.5, VI.3, VII.6, IX.1, IX.2, IX.3, IX.4, IX.5 XI.1 and XI.3 and the Pharmacovigilance Agreement; as far as BIOVENTUS is
concerned, the uncured breach of any of its obligation under Paragraphs II.3, III.1, V.l, V.5, VII.l, VII.2, VII.3, VII.4, VII.8, VII.9, VIII.l, IX.2, XI.2, XI.3, XIV.l, XIV.2, XXI.3 and the Pharmacovigilance Agreement; in each case, by giving
written notice of termination to the other Party specifying that breach and requiring the same to be remedied. The Party in breach shall be given a [***] month period to fulfill its obligations hereunder and, if after such period it is still
in breach of contract, the Party not in breach shall have the right to terminate this Agreement forthwith, without prejudice to the obligations or liabilities of either Party already accrued prior to such termination. If the Party in breach has
cured the breach by the end of the [***] month period, then this Agreement will not terminate. 

  

	 	XVII.3	 This Agreement may be terminated by a Party upon written notice to the other Party if such other Party shall
become insolvent, suspend payments on any of its trade payables or announced an intention to do so, is over-indebted or be unable to pay its debts as they fall due or shall make an assignment for the benefit of creditors, become involved in
receivership, bankruptcy or any proceedings leading to a provisional or definitive payment moratorium, any proceeding leading to an emergency moratorium, any proceeding for a postponement of bankruptcy pursuant to article 725a of the Swiss Code of
Obligations, or enter into negotiations with the majority of its creditors seeking a composition or a maturity postponements or other insolvency or debtor relief proceedings, or any similar proceedings, or in proceedings, voluntary or forced,
whereby such Party is limited in the free and unrestrained exercise of its own judgment as to the carrying out of the terms of this Agreement. 

  

	Art. XVIII.	 RIGHTS AND DUTIES AFTER TERMINATION 

 

	 	XVIII.1	 Upon the effective date of expiration or termination of this Agreement for whatsoever reason, BIOVENTUS shall
immediately (i) refrain from using the TRADEMARK and KNOW-HOW in the TERRITORY and elsewhere and (ii) assign back to IBSA or a company indicated by IBSA, the TRADEMARK. 

 

	 	XVIII.2	 Upon the effective date of expiration or termination of this Agreement for whatsoever reason, IBSA shall:

 (i) fulfill those orders placed by BIOVENTUS and accepted by IBSA before termination; and 

  
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 (ii) at its option, purchase from BIOVENTUS at the price paid by BIOVENTUS to IBSA plus
landed costs, all or any part of current inventories at BIOVENTUS costs (i.e. PRODUCT cost [***]% ([***] percent) to cover transportation and handling) provided that such inventories/stock conform to the provisions of this Agreement.
Such option shall be exercised by written notice within [***] days from the effective date of termination. Should IBSA not exercise such option, BIOVENTUS shall be entitled to sell the PRODUCT in the TERRITORY at prices which will not perturb
the market and/or the ordinary distribution of the PRODUCT by IBSA or any new distributor. Any non-saleable (e.g. damaged) inventory shall be destroyed by BIOVENTUS at its own cost. 

 

	 	XVIII.3	 Upon the effective date of expiration or termination of this Agreement for whatsoever reason, each Party shall,
within [***] days following the termination for whatsoever reason of this Agreement, return all CONFIDENTIAL INFORMATION to the other Party. It is understood that each Party may retain in the office of its legal advisor only one copy of the
written CONFIDENTIAL INFORMATION for record purposes only. 

  

	 	XVIII.4	 It is understood and agreed by and between the Parties hereto that neither the expiration nor termination of
this Agreement for whatsoever reason will oblige IBSA and/or any of its AFFILIATES to indemnify BIOVENTUS on account of such termination. 

  

	 	XVIII.5	 Upon expiration or termination of this Agreement, IBSA shall automatically get again the full right and
entitlement to market the PRODUCT. In view of the above. BIOVENTUS shall take any desirable and necessary step, that is reasonable and permitted by the laws of the TERRITORY, in order to give back to IBSA or to any other company designated in
writing by IBSA, the possibility of marketing the PRODUCT in the TERRITORY; 

  

	Art. XIX.	 CHANGE OF SHAREHOLDING CONTROL 

Each Party shall promptly inform the other Party in writing of any CHANGE OF SHAREHOLDING CONTROL. If the CHANGE OF SHAREHOLDING CONTROL would
result in a PRODUCT COMPETITOR acquiring control of BIOVENTUS, notwithstanding any other provision of this Agreement, IBSA shall have the right, in each MARKETING YEAR for the entire duration of this Agreement following receipt of such notice from
BIOVENTUS, either (i) to ask BIOVENTUS to pay a penalty of [***]% of the unpurchased quantities of the annual MINIMUM PURCHASE REQUIREMENT or (ii) to terminate this Agreement for BIOVENTUS’ failure to purchase [***]%
([***] percent) of the applicable MINIMUM PURCHASE REQUIREMENT or [***]% ([***] percent) of the actual quantities purchased in the previous MARKETING YEAR, whichever is higher. 

 

	Art. XX.	 JURISDICTION 

  

	 	XX.1	 This Agreement and the legal relationship between the Parties hereto shall be governed by the laws of
Switzerland, without regard to provisions on the conflicts of laws. 

  

	 	XX.2	 In the event of any dispute arising out of or in connection with the execution or the interpretation of this
Agreement, both Parties will endeavor to settle such dispute amicably between themselves. 

  
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	 	XX.3	 All disputes arising in connection with this Agreement shall be resolved by arbitration in accordance with the
Swiss Rules of International Arbitration of the Swiss Chambers’ Arbitration Institution in force on the date on which the Notice of Arbitration is submitted in accordance with these Rules. 

The number of arbitrators shall be three. 

The seat of the arbitration shall be [***] 

The arbitral proceedings shall be conducted in English. 
  

	Art. XXI.	 ART. XXI MISCELLANEOUS 

 

	 	XXI.1	 Neither Party shall be in default hereunder by reason of its delay in the performance of, or failure to
perform, any of its obligations hereunder, if such delay is caused by strikes, acts of God or public enemy, riots, incendiaries, interference by civil or military authorities, compliance with government laws, rules and regulations, inability to
secure necessary governmental priorities for the materials, or any circumstances beyond its control and without its fault or negligence. 

  

	 	XXI.2	 If any of the terms or provisions of this Agreement are in conflict with any applicable statute or rule of law,
then such terms or provisions shall be deemed inoperative to the extent that they may conflict therewith, and shall be modified to conform with such statute or rule of law, in such form as will most closely reflect the commercial and mutual intent
of the Parties under this Agreement. 

  

	 	XXI.3	 This Agreement will be binding upon and endure to the benefit of the Parties, their AFFILIATES and/or
subsidiaries. This Agreement may not be assigned by either Party, other than to an AFFILIATE, without the prior written consent of the other Party; provided, however, that notwithstanding the foregoing, no such consent shall be
required for a Party to assign this Agreement in connection with a merger, sale of all or substantially all assets or other change of control transaction involving such Party or its line of business to which this AGREEMENT relates. The Parties
hereto undertake to impose the obligations of the Agreement on all their respective legal successors and/or assignees. 

  

	 	XXI.4	 The failure by either Party to exercise any rights granted herein or to require any performance of any term of
this Agreement or the waiver by either Party of any breach of this Agreement shall not prevent a subsequent exercise or enforcement of, or be deemed a waiver of any subsequent breach of the same or any other term of this Agreement.

  

	 	XXI.5	 No change or modification in the conditions or clauses of this Agreement shall be valid unless written and
signed by both Parties. 

  

	 	XXI.6	 This Agreement constitutes the entire agreement between the parties with respect to the subject matter and
supersedes all prior and other agreements and understandings, whether oral or written. 

  
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	Art. XXII.	 NOTICES 

  

	 	XXII.1	 Any paper to be served or notified to the Parties shall be sent by e mail and confirmed by registered letter
properly addressed to the Party concerned at the address stated in the preamble to this Agreement, and the time limit shall be counted from the date of the e mail. 

 

	 	XXII.2	 Either Party may change such address by [***] days prior written notice. The contract language is
English. 

 [Remainder of page intentionally left blank; signature page follows] 

  
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 IN WITNESS THEREOF, the Parties hereto have caused this Agreement to be executed in duplicate
by their duly authorized officers as of the day and year written below. 
  

					
	IBSA Institut Biochimique SA	 		 	BIOVENTUS LLC
			
	(Switzerland)	 		 	(United States of America)
			
	 /s/ Elisabetta Racca
	 		 	 /s/ Anthony P. Bihl III

	Name: Ms. Elisabetta Racca	 		 	Name: Anthony P. Bihl III
			
	Title: Legal Affairs	 		 	Title: CEO
			
	Date: February 3, 2016	 		 	Date: February 3, 2016

  
 19 

 Annex A. 

SPECIFICATIONS OF THE PRODUCT 

Gel-Syn 0.84% Release Specification - USA market - 2014 Approval 

 

			
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 20 

 Annex B. 

TRADEMARKS 
  

	1.	
GEL-SYNTM, US Trademark Application
Serial No. 86/376,022, filed on September 9, 2014, published on January 1, 2015, for classes 5 and 10 

  

	2.	
GELSYN-3TM, US Trademark Application
Serial No.86/888,721, filed on January 27, 2016, for classes 5 and 10 

  
 21 

 Annex C. 

SDEA 
 Standard
Operating Procedure for Exchange of Safety Information (SDEA) on PRODUCT between IBSA Institut Biochimique SA and BIOVENTUS LLC 
  

	1.	 PURPOSE 

The purpose of this document is to describe the standard operating procedures for exchange of safety information on
Gel-SynTM (hereinafter the PRODUCT), and to ensure that incidents, adverse events, abnormal use and use errors will be collected and managed by both
IBSA Institut Biochimique SA (Switzerland) (hereinafter IBSA) and BIOVENTUS LLC (United States of America) (hereinafter DISTRIBUTOR) in compliance with applicable domestic, extra-European and European laws, regulations and regulatory authority
guidelines in line with their respective responsibilities. IBSA Farmaceutici Italia s.r.l., a company of IBSA Group, is identified as MANUFACTURER of the PRODUCT in the terms of the Art. I paragraph 2f of the EU Directive 93/42/EEC and subsequent
amendments and according to 21CFR803 “Medical Device Reporting”, concerning medical devices. 
 This Safety Data Exchange Agreement (hereinafter
SDEA) makes reference and is to be regarded as an integral part to the existing Commercial License Agreement between DISTRIBUTOR and MANUFACTURER. This agreement may be amended only by a written document, signed by both parties. 

 

	2.	 SCOPE 

This SDEA shall include incidents, Adverse Events, abnormal use and use errors, irrespective of the source (e.g. spontaneous, literature, regulatory
authorities), arising from the use of the PRODUCT, communicated to any employee of both Parties, including representatives. This agreement covers the PRODUCT and the TERRITORY defined in the Distribution Agreement. DISTRIBUTOR delegates activities
related to collection, assessment, preparation and medical review of Adverse Events including due diligence to Clinquest, Inc. (“Clinquest”) but they remain under DISTRIBUTOR responsibility. 

 

	3.	 DEFINITIONS 

The following terms, with the exception of terms “Adverse Event” and “Parties”, should be understood as defined in the “Guideline on a
Medical Devices Vigilance system (MEDDEV 2.12-1, current edition)” and in the “Medical Device Reporting” (CFR TITLE 21- Part 803). 

Abnormal Use: Act or omission of an act by the operator or user of a medical device as a result of conduct which is beyond any means of risk control by
the Manufacturer. 
 Adverse Event: Any untoward medical occurrence in a patient during the use of a medical device. 

Becomes Aware—according to 21CFR803: Manufacturer “Becomes aware” of a MDR reportable event when (1) any employee becomes aware of
a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days pursuant to a written request from FDA; and (2) any employee, who is a person with management or supervisory
responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable event, from any information, including any
trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. 

  
 22 

 Caused or Contributed — according to 21CFR803: Means that a death or serious injury was or may
have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: failure – malfunction – improper or inadequate design –
manufacture – labeling – user error. 
 Complaint: Means any written, electronic, or oral communication that alleges deficiencies related
to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. 
 Corrective
Action: Action to eliminate the cause of a potential nonconformity or other undesirable situation. 
 Distributor – according to
21CFR803: Any person (other than manufacturer or importer) who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise
change the container, wrapper, or labeling of the device or device package. 
 Field Safety Corrective Action (FSCA) – according to MEDDEV 2.12-1 rev. 8: A Field Safety Corrective Action (FSCA) is an action taken by the Manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a Medical Device
that is already placed on the market. Such actions, whether associated with direct or indirect harm, should be reported and should be notified via a Field Safety Notice (FSN). 

Field Safety Corrective Action may include: 
  

	 	•	 	 return of the medical device to the supplier; 

 

	 	•	 	 device modification; 

  

	 	•	 	 device exchange; 

  

	 	•	 	 destruction of the device; 

 

	 	•	 	 retrofit by purchaser of manufacturer’s modification or design change 

 

	 	•	 	 advice given by manufacturer regarding the use of the device and/or the follow up of patients, users or others
(e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants or change in analytical sensitivity or specificity for diagnostic devices). 

Modifications to the device may include: 
  

	 	•	 	 temporary or permanent changes to the labelling or the instructions for use; 

 

	 	•	 	 changes to the patient’s clinical management, in order to inform the patient of the risk of death or serious
deterioration in health, closely linked to the characteristics of the device. 

 Field Safety Notice (FSN)—according to MEDDEV 2.12-1 rev.8: A communication to customers and/or users sent out by a Manufacturer or its representative in relation to a Field Safety Corrective Action. 

  
 23 

 Harm: Physical injury or damage to the health of people, or damage to property or the environment.
Immediately, without any delay that could not be justified. 
 Incident: 

 

	 	•	 	 Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy
in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to serious injury or the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

  

	 	•	 	 Any technical or medical reason related to the characteristics or performances of a device (see first bullet
point) that leads to a systematic recall of devices of the same type by the manufacturer. 

 Incident causing death:
An incident (adverse event) in which a medical device has caused or contributed to the death of a patient or user. To establish the causal relationship between the use of the device and the death, various factors should be considered (potential
risks in using the device, characteristics of the device itself, patient conditions etc.) and the assessment carried out by the doctor and/or other healthcare professional who assisted the event, should always be taken into consideration. Even if
there is a mere suspicion, the incident (adverse event) should be repotted. 
 Incident causing a serious injury: A serious deterioration in state of
health can include: 
  

	 	a)	 life-threatening illness, 

 

	 	b)	 permanent impairment of a body function or permanent damage to a body structure, 

 

	 	c)	 a condition necessitating medical or surgical intervention to prevent a) or b). 

Examples: – clinically relevant increase in the duration of a surgical procedure, 

– a condition that requires hospitalisation or significant prolongation of existing hospitalisation. 

 

	 	d)	 foetal distress, foetal death or any congenital abnormality or birth defects 

Information Reasonably Known – according to 21CFR803: Information that can be obtained by contacting a user facility,
distributor and/or initial reporter, any information in manufacturer’s possession, or any information that can be obtained by analysis, testing or other evaluation of the device. 

Information Reasonably Suggests – according to 21CFR803: Any information such as professional, scientific, or medical facts
and observations or opinions, that would reasonably suggest that a device has caused or contributed to a reportable event. 
 Malfunction
– according to MEDDEV 2.12-1 rev.8: A “malfunction” is a failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications
include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed. 

  
 24 

 Manufacturer – according to 21CFR803: Any person who manufacturers, prepares,
propagates, compounds, assembles or processes a device by chemical, physical, biological or other procedure. The term includes any person who is the U.S. agent of a foreign manufacturer. 

Manufacturer – according to MEDDEV 2.12-1 rev.8: The natural or legal person with
responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

 Medical Device Report (MDR) – according to 21CFR803: A report submitted to the FDA by the Manufacturer in the event a device
may have caused or contributed to a death, serious injury, or has malfunctioned and that the device or a similar device marketed by the manufacturer would likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 MDR Reportable Event – according to 21CFR803: “MDI reportable event” means an event that manufacturer become aware
of that reasonably suggests that one of their marketed devices: 
  

	 	1)	 may have caused or contributed to a death or serious injury, or 

 

	 	2)	 has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause
or contribute to a death or serious injury if the malfunction were to recur. 

 MDR
Non-Reportable Events – according to 21CFR803: The following is a list of events that are not reportable: 
  

	 	•	 	 Malfunctions are not reportable if they are not likely to result in a death, serious injury or other significant
adverse event experience; 

  

	 	•	 	 When the manufacturer determines, on the basis of qualified medical judgment, that the information that they
received is inaccurate and a death or serious injury did not occur; 

  

	 	•	 	 When another manufacturer made the device. 

Parties: The MANUFACTURER and the DISTRIBUTOR. 

Periodic Summary Reporting: an alternative reporting regime that is agreed between the Manufacturer and the National Competent
Authorities for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented. 

Remedial Action: Any action other than routine maintenance or servicing of a device, necessary to prevent recurrence of a reportable
event. 
 Report Form Manufacturer’s Incident Report – according to MEDDEV 2.12-1
rev.8: The report used to notify the adverse incidents that occurred within the Member States of the European Community and all other States within the European Economic Area (EEA) with regard to medical device(s), which carry the CE marking.
Annex 3 of MEDDEV 2.12-1 rev.8. 

  
 25 

 Report Form Manufacturer’s Periodic Summary Report (PSR) – according to MEDDEV 2.12-1 rev.8: The report used to notify the adverse incidents that occurred within the Member States of the European Community and all other States within the European Economic Area (EEA) with regard to medical
device(s), which carry the CE marking. Annex 6 of MEDDEV 2.12-1 rev. 8. 
 Report Form
Manufacturer’s Trend Report – according to MEDDEV 2.12-1 rev.8: The report used to notify the adverse incidents that occurred within the Member States of the European Community and all other
States within the European Economic Area (EEA) with regard to medical device(s), which carry the CE marking. Annex 7 of MEDDEV 2.12-1 rev.8. 

Serious Public Health Threat: Any event type which results in imminent risk of death, serious deterioration in state of health, or
serious illness that requires prompt remedial action. 
 This would include: 

 

	 	•	 	 events that are of significant and unexpected nature such that they become alarming as a potential public health
hazard, e.g. human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD). These concerns may be identified by either the National Competent Authority or the Manufacturer. 

 

	 	•	 	 the possibility of multiple deaths occurring at short intervals 

Trend Reporting: A reporting type used by the Manufacturer when a significant increase in events not normally considered to be Incidents
(and thus that are usually excluded from individual reporting) occurred and for which pre-defined trigger levels are used to determine the threshold for reporting. 

Use Error: Act or omission of an act, that has a different result to that intended by the Manufacturer or expected by the operator of
the Medical Device. 
 Other definitions: 

“Business Day” means a day which is NOT a Saturday, Sunday, DISTRIBUTOR or MANUFACTURER corporate or public holiday. 

“Calendar Day” means any day including Saturday, Sunday, DISTRIBUTOR or MANUFACTURER corporate and public holidays. 

“Day 0” means the date the DISTRIBUTOR received or becomes aware of the information. 

 

	4.	 GLOBAL SAFETY DATABASE 

The MANUFACTURER is responsible for the vigilance of the PRODUCT and will maintain the database for the all the safety information sent by DISTRIBUTOR. This
is the reference database for the safety of the PRODUCT. 
 Also the DISTRIBUTOR maintains a local database to record the safety information. 

  
 26 

 Each party will make its own case reference number, which will be exchanged with the other. Therefore,
MANUFACTURER shall review the safety data accumulated in the global safety database periodically, in particular when reviewing the Annual Safety Reports prepared by DISTRIBUTOR, and for answering safety-related questions. 

 

	5.	 ADVERSE EVENTS MANAGEMENT 

 

	 	5.1	 Collection and Exchange of Safety Information 

 

	 	5.1.1	 Safety Information occurred outside the TERRITORY and received by the MANUFACTURER

 The MANUFACTURER forwards to DISTRIBUTOR all the incident and/or any safety information related to the PRODUCT and occurred outside
the TERRITORY that need to be submitted to the TERRITORY Health Authority -the Food and Drug Administration (FDA)- according to the following time-lines (calendar days). 

 

					
	report TYPE	  	METHOD OF
TRANSFER	  	TIMELINES
	
5-day report
	  	 - email
	  	 Day
[***]

	
Follow-up report (to 5-day
report)
	  	 - email
	  	 Day
[***]

	
30-day report
	  	 - email
	  	 Day
[***]

	
Follow-up report (to 30-day
report)
	  	 - email
	  	 Day
[***]

  

	 	5.1.2	 Safety Information occurred in the TERRITORY and received by the DISTRIBUTOR 

Safety information for the PRODUCT, including incidents, reports of use error and abnormal use and Adverse Events (AEs), associated or not with a technical
complaint, may be acquired through reporting from multiple sources (e.g. spontaneous reports, scientific literature, regulatory authorities). DISTRIBUTOR shall collect any initial and follow-up information in
accordance with own company’s internal standard operating procedures and the applicable local regulatory requirements. When the DISTRIBUTOR takes knowledge of any new safety information, DISTRIBUTOR forwards immediately and in any case not
later than [***] hours all the information available to MANUFACTURER, using xml file and CIOMS-I Form,: 
  

					
	Report TYPE	  	METHOD OF
TRANSFER	  	TIMELINES
	
death or serious
  

deterioration in
  

state of health
  
	  	 - email
	  	 Day
[***]

	
other cases
	  	 - email
	  	 Day
[***]

  
 27 

	 	5.2	 Spontaneous reports 

Once a safety report is received by DISTRIBUTOR, MANUFACTURER shall investigate each incident, adverse event, abnormal use and user error brought to its
knowledge and issue an initial, a follow-up and a final report, including the case assessment, and forward them to DISTRIBUTOR for their submission to FDA, if needed. 

MANUFACTURER retains responsibility for event coding, assessment of case seriousness, expectedness, and for informing DISTRIBUTOR of any changes made to case
seriousness, expectedness or otherwise within [***] business days. 
  

	 	5.3	 Follow-up 

The DISTRIBUTOR is responsible in following-up all the incidents, adverse events, abnormal use and user errors, as
needed: in any case, at least [***] follow-up attempts should be performed. The information, once acquired, shall be transmitted in the same way as the initial one to the MANUFACTURER. 

The MANUFACTURER shall make at least [***] follow-up attempt for cases received by MANUFACTURER itself, that
are expedited in the TERRITORY in accordance with the TERRITORY regulations. 
 All follow-up attempts should be
documented in writing. 
  

	 	5.4	 Reporting 

MANUFACTURER shall fulfill its respective reporting obligations, in accordance with the applicable laws and regulations, in relation to the PRODUCT in the
country/territory of its responsibility, unless otherwise agreed. 
 MANUFACTURER is responsible for the reporting to the Worldwide Health Authorities
(excluding the United States) for the PRODUCT, in accordance with the applicable laws and regulations. DISTRIBUTOR, on behalf of MANUFACTURER is responsible to submit the reportable reports to FDA, as needed, and in accordance with the applicable
laws and regulations. A proof of the performed submission will be sent to the MANUFACTURER. 
 DISTRIBUTOR will determine regulatory actions required in the
TERRITORY based upon information provided by MANUFACTURER, 
 DISTRIBUTOR shall keep MANUFACTURER duly informed of any existing or new rule and/or
regulation issued by FDA. DISTRIBUTOR is responsible for communicating MANUFACTURER without delay (and no later than the date they become effective) any important changes in safety reporting requirements. 

 

	 	5.5	 Reconciliation of Safety Information 

A reconciliation is done on [***] basis. [***], DISTRIBUTOR shall provide MANUFACTURER with a line-listing of all the locally occurred
incident, adverse event, abnormal use and error received use received in the given month and associated with the PRODUCT. The line-listing will be sent within the first [***] working days of the following calendar month. IBSA shall confirm
correctness of the list within [***] working days forwarding its own line-listing. Both line-listings are used for verifying that all the safety information has been exchanged and for performing an additional check of duplicates. In case of
discrepancies, the issue will be investigated by both parties. 

  
 28 

	6.	 TREND ANALYSIS 

The MANUFACTURER is responsible for proactive scrutiny of trends in adverse events or incidents that are usually excluded from individual reporting and for
preparing trend reports if a significant trend is detected. 
 The MANUFACTURER is responsible for communicating to DISTRIBUTOR information about such
trends, as applicable. 
  

	7.	 FIELD SAFETY CORRECTIVE ACTIONS (FSCA) AND FIELD SAFETY NOTICES (FSN) 

The MANUFACTURER is responsible for all actions to be taken as a result of the knowledge of an incident. The MANUFACTURER is required to evaluate the issue of
a Field Safety Notice or to implement a Field Safety Corrective Action, depending on the severity, the results of investigations and the context characterising the occurrence of one or more incidents, when necessary. The MANUFACTURER is required to
timely inform the DISTRIBUTOR about any corrective action, the will for implementing a Field Safety Corrective Action or for issuing a Field Safety Notice. 

The DISTRIBUTOR is responsible for supporting the MANUFACTURER in implementing the Field Safety Corrective Action disposed by MANUFACTURER, as agreed with the
Competent Authority. DISTRIBUTOR, on behalf of the MANUFACTURER, is required to inform FDA about the FSCA and/or the FSN, in accordance with the applicable laws and regulations. A proof of the performed submission will be sent to the MANUFACTURER.

  

	8.	 ANNUAL SAFETY REPORTS 

DISTRIBUTOR, on behalf of MANUFACTURER, shall prepare the Annual Safety Reports that need to be submitted to FDA, in accordance with the applicable laws and
regulations. MANUFACTURER undertakes to supply DISTRIBUTOR with any relevant information required for the completion of these documents within [***] calendar days from the date of the request by DISTRIBUTOR. 

DISTRIBUTOR should send to MANUFACTURER the final draft for revision not less than [***] weeks before submission for MANUFACTURER to review and
comment. MANUFACTURER shall review the draft and provide comment to DISTRIBUTOR no later than [***] calendar days from its receipt. 
 The submission
to FDA will be done by DISTRIBUTOR and a copy of the final report and of the submission letter to FDA will be provided to MANUFACTURER. 
  

	9.	 LITERATURE REVIEW 

The DISTRIBUTOR, at least once a year, will make a search of the local literature available and when a published adverse event or incident related to the
PRODUCT or its components is found to be occurred in the TERRITORY, the DISTRIBUTOR will inform the MANUFACTURER with the timelines and form described in paragraph 5.1.2. 

  
 29 

	10.	 ACKNOWLEDGEMENT 

Upon receipt of a report, each Patty shall acknowledge receipt and provide their unique case ID number to the other Party within [***] business day for
reconciliation purposes. These acknowledgements will be sent by fax or e-mail (for emails, the date when the message was delivered is considered the receipt date). If no acknowledgement is received for a
report after [***] business days, the other Party will be contacted. 
  

	11.	 TRAINING 

Each Party will ensure that its personnel are trained on market-surveillance issues, and is responsible for the training of sales representatives on the role
and responsibilities in the collection and transmission of surveillance information, as well as on the safety profile of the PRODUCT, within a reasonable time period following execution of this Agreement, as necessary to ensure compliance with this
Agreement and with the Applicable Law. 
 Each party will establish and maintain records in departmental safety files on policies and standard operating
procedures to ensure compliance with this Agreement and the Applicable Law. The training has to be tracked and the evidence of the training performed by DISTRIBUTOR has to be sent to MANUFACTURER. 

 

	12.	 LABELLING ACTIVITIES 

The MANUFACTURER is responsible for maintaining and managing the correct label of the PRODUCT in compliance with regulations and to keep the DISTRIBUTOR
informed of any change in the labelling. 
  

	13.	 CHANGES IN REGULATORY REQUIREMENTS 

The PARTIES are responsible for communicating each other without delay (and no later than the moment become effective) any changes of essential requirements in
the countries where the PRODUCT is marketed by the Parties. 
  

	14.	 COMMON LANGUAGE 

English will be used as a common language for exchange of any information between the Parties. 

 

	15.	 RECORDS 

Both DISTRIBUTOR and MANUFACTURER will maintain records and all related documentation (or true copies of these documents) of incidents and adverse events as
long as the product is on the market and for at least [***] years after the expiration date of the last batch issued on the market. 
  

	16.	 AUDITS 

DISTRIBUTOR and MANUFACTURER will keep accurate records in sufficient detail. The DISTRIBUTOR will permit MANUFACTURER, its designee or an independent auditor
appointed by MANUFACTURER, to conduct an audit once a year to ensure the good effectiveness of this agreement. Any audit shall be conducted at the MANUFACTURER’S expenses during the ordinary business hours and upon reasonable notice (at least
[***] days before the date of audit). 

  
 30 

 The MANUFACTURER shall have the right to make an additional justified “for cause” audit even
during the same calendar year, when required or based on the previous audit outcome. The MANUFACTURER will permit DISTRIBUTOR, its designee or independent auditor appointed by DISTRIBUTOR, to conduct an audit once a year to ensure the effectiveness
of this Agreement. Any audit shall be conducted at the DISTRIBUTOR’S expense during ordinary business hours and upon reasonable notice (at least 30 days before the date of audit). 

 

	17.	 RISK MANAGEMENT PLAN 

MANUFACTURER is responsible for establishing and maintaining the Risk Management Plan (RMP) for the PRODUCT, according to the current regulatory requirements,
when needed. 
  

	18.	 SAFETY ACTIONS ORIGINATING IN TERRITORY (-IES)

 DISTRIBUTOR shall immediately inform MANUFACTURER upon receiving information or communication regarding any possible safety actions
related to the PRODUCT in the TERRITORY including, but not limited to, communications from Competent Authorities. DISTRIBUTOR shall provide a copy of any written communication to MANUFACTURER. Where applicable, the Parties shall work together to
respond to such inquiries. DISTRIBUTOR shall not submit any information to FDA without prior written approval from the MANUFACTURER. Each Parties shall use its best efforts to provide the necessary information to respond in given timeframes. 

If specific Corrective Actions issued by MANUFACTURER are to be taken, the DISTRIBUTOR shall implement such actions in the TERRITORY. 

 

	 	18.1    Safety-based	 Recall 

In the occurrence of a situation that may warrant a safety-based recall the Party who first becomes aware of the situation and/or within the TERRITORY shall
inform the other Party within [***] hours. Both Parties shall work together according to their respective SOPs in order to clarify the extent of the risk and generate a risk management strategy with actions to be taken. Any PRODUCT recalls
are conducted under the responsibility of the MANUFACTURER. 
  

	19.	 CONFIDENTIALITY 

The Parties agree that all information provided by the other Party will be treated as confidential. Notwithstanding the above, DISTRIBUTOR and MANUFACTURER may
quote the above-mentioned information to respond to medical queries from healthcare professionals in the TERRITORY. The MANUFACTURER may disclose such information to its subsidiaries, other companies and distributors that have marketed the PRODUCT
in other countries. Once subsidiaries, companies and distributors receive this kind of information, they are bound to keep such information confidential in line with the terms of this article. 

The obligations set forth in this Article will survive any termination of this SDEA for a period of [***] years after the effective date of
termination. 

  
 31 

 The obligation of confidentiality and non-use in this Article shall
not apply to information which 
  

	 	a)	 at the time of its disclosure by the disclosing Party was known by the receiving Party 

 

	 	b)	 was in the public domain or which subsequently comes into the public domain through no fault of the receiving
Party 

  

	 	c)	 is independently developed by the receiving Party without use or reference to the information disclosed by the
disclosing Party 

  

	 	d)	 is required by law to be disclosed. 

 

	20.	 MISCELLANEOUS 

This SDEA will be effective upon signature of both Parties. 

This SDEA may be revised as necessary to make it conform to new or amended legal or regulatory requirements in the TERRITORY. If one or more provisions of
this SDEA become void, the validity of the remaining provisions shall not be affected. 
 This SDEA remains effective until termination of the business
relationship for PRODUCT between DISTRIBUTOR and MANUFACTURER. 
 In case of a discrepancy between any provisions of this SDEA and the existing Agreements
between DISTRIBUTOR and MANUFACTURER, the provisions of this SDEA shall apply. 
  

	21.	 CONTACT PERSONS 

The MANUFACTURER and the DISTRIBUTOR undertake to designate a responsible person who is the reference person to ensure that this Agreement will be applied. Any
change in the responsible or contact details should be notified to the other Party immediately and in no case later than [***] calendar days in writing. 

Any written notification of changes shall be maintained with this SDEA. 

  
 32 

 SAFETY CONTACTS 
  

					
	 	 	 
	IBSA	  	Primary	  	Back-up
	 	 	 
	 Name:

 
	  	 	  	 
	 	 	 
	 Title

 
	  	 	  	 
	 	 	 
	 Telephone

 
	  	 	  	 
	 	 	 
	 Mobile

 
	  	 	  	 
	 	 	 
	 Fax

 
	  	 	  	 
	 	 	 
	 E-mail

 
	  	 	  	 
	 	 	 
	 E-mail for AE/ADR reporting

 
	  	 	  	 
	 	 	 
	 BIOVENTUS

 
	  	 Primary
  
	  	 Back-up

 

	 	 	 
	 Name

 
	  	 	  	 
	 	 	 
	 Title

 
	  	 	  	 
	 	 	 
	 Telephone

 
	  	 	  	 
	 	 	 
	 Mobile

 
	  	 	  	 
	 	 	 
	 Fax

 
	  	 	  	 
	 	 	 
	 E-mail

 
	  	 	  	 
	 E-mail for AE/ADR reporting

 
	  	 	  	 

  
 33 

	1.	 SIGNATURES 

This SDEA is approved by IBSA and BIOVENTUS on the dates set forth below. 
  

			
	On behalf of IBSA	  	
		
	 /s/ Mara Delledonne
	  	
	Mara Delledonne	  	Date: 09 February 2016
	MD Vigilance	  	
		
	On behalf of BIOVENTUS	  	
		
	 /s/ Anthony James
	  	
	Anthony James	  	Date: 3-7-16
	VP, Operations & Quality	  	

  
 34 

 Annex D. 

TRANSFER PRICES 
 BIOVENTUS will purchase
exclusively from IBSA (subject to Article II.3 of the Agreement) all of its requirements of the PRODUCT for the TERRITORY, at a TRANSFER PRICE equal to [***] of the NET SELLING PRICE in the TERRITORY. Except as set forth in this Agreement, in
no event, shall the TRANSFER PRICES from IBSA to BIOVENTUS be less than the following floor price (the “FLOOR PRICE”): 
  

			
	One box PRODUCT (Trade) containing one pre-filled syringe + one needle	  	 US$ [***]

		
	One box PRODUCT (Sample) containing one pre-filled syringe + one needle	  	 US$ [***] (*)

		
	Delivery terms: ex-works IBSA warehouse [***]	  	

 (*) Samples shall not exceed [***] units through the end of the calendar year 2016 and [***] percent
([***]%) of the total number of units purchased by BIOVENTUS from IBSA each MARKETING YEAR thereafter. 

  
 35

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