Document:

License Agreement (between Q-Med AB and Cetacea Limited)

 Exhibit 10.88 
 Portions of this exhibit marked [*] are omitted and 
 are requested to be treated
confidentially. 
 Execution Copy 
  

 
  

LICENSE AGREEMENT 
 BETWEEN 
 CETACEA LIMITED

 AND 
 Q-MED AB 
  

 
  

 LICENSE AGREEMENT 

This License Agreement is made and entered into this 2nd day of June, 2009 by and between Q-MED AB, a corporation of organized under the
laws of the Kingdom of Sweden with corporate registration number 556258-6882 (“Q-Med”), and CETACEA LIMITED, a limited company organized under the laws of the Republic of Ireland (“Ireland”). Each of Q-Med and
Ireland shall be referred to herein as a “Party” and collectively as the “Parties.” 
 BACKGROUND:

 Q-Med is engaged in the research, development and commercialization of pharmaceutical products and/or
medical devices. Q-Med has developed its Deflux® and Solesta® products containing polymerized and cross-linked hyaluronic acid and dextranomer microspheres, wherein the
hyaluronic acid is derived from non-animal sources, for the treatment of urinal incontinence and vesicoureteral reflux and fecal incontinence respectively. Ireland possesses capabilities in the promotion and marketing of pharmaceutical products
and/or medical devices and is a wholly-owned subsidiary of Q-Med. Q-Med desires to grant, and Ireland desires to obtain, the rights and licenses set forth herein with respect to Licensed Products (as defined herein), upon the terms and
conditions set forth in this Agreement (as defined herein). 

  
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 The Parties agree as follows: 

ARTICLE I 

DEFINITIONS 
 1.1 Definitions. All capitalized terms not otherwise defined in this Agreement shall have the meaning given to such term in the Ireland Supply Agreement. For the purposes of this Agreement, the
following words and phrases shall have the following meanings: 
 “937 Patent” means the patent bearing U.S.
Patent No. 5,827,937 and entitled “Polysaccharide gel composition” and any of its foreign counterparts, together with any extensions, reissues, continuations, divisionals, continuations-in-part, reexamination certificates,
substitutions or renewals, supplemental protection certificates or certificates of inventions thereof. 

“Actions” means any action, claim, suit, litigation, arbitration, investigation, notification or other proceeding
brought by a Governmental Authority or other person. 
 “Affiliate” of an entity means any other entity that,
directly or indirectly, controls, is controlled by, or is under common control with, the entity. For purposes of this definition, the ownership of 50% or more of the equity or voting interests in such other entity shall presumptively mean that such
entity “controls” such other entity. An entity that is an investment company (including, for the avoidance of doubt, Oceana Holding, LLC), whether or not registered under the Investment Company Act of 1940, as amended, shall not be deemed
an Affiliate of Ireland. 
 “Agreement” means this Agreement and all schedules and exhibits attached hereto, as
the same may be amended or supplemented from time to time in accordance with the terms hereof. 
 “ASP” means
the Average Sales Price, which shall be calculated by dividing the Net Sales of Licensed Product in the applicable territory in a quarter or other measurement period agreed to by the parties, by the number of Units of Licensed Product reflected in
such Net Sales. 
 “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 

  
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national bank holiday (by law or executive order) 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, forecast or notice shall be due on the next day on which banks in such country(ies) are open for business. 

“CE Mark” means the CE marking of conformity/EC Design Examination issued by a Notified Body in the European Union,
including 2021098CE03 and 2021098DE05 for the Deflux Product and CE 2021098CE08 and DE 2021098DE12 for the Solesta Product. 

“Commercialization” or “Commercialize” means any and all activities directed to: (i) marketing,
promoting, distributing, importing, offering to sell and/or selling the Licensed Products, including market research, seeking appropriate reimbursement, billing and coding support for physicians and clinics, product related public relations,
planning, detailing, marketing, distribution, creative development of visual sales aids, direct mail, telemarketing and teledetailing, media placement and advertising, field marketing events, and sales meetings; and (ii) medical affairs support
(including medical education programs, medical meetings and educational grants), regulatory affairs and quality assurance support (including adverse event reporting and post-market surveillance studies, whether for marketing purposes, post-marketing
experience investigations, regulatory compliance or as a condition to obtaining, maintaining or amending a Regulatory Approval). For purposes of clause (i) of this definition, in reading Sections 2.4 and 3.1(b) below, this term shall include
products other than Licensed Products. 
 “Commercially Reasonable Efforts” means, with respect to Ireland,
exerting such effort and employing such resources as would normally be exerted or employed by a U.S. specialty pharmaceutical company of comparable revenues, assets and committed capital resources as Ireland, or, with respect to Q-Med, a Swedish
medical device company, taking into 

  
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account all relevant considerations including, the phase of development of, and technical risks relating to, the product, the development and proprietary positions of Third Parties, the
regulatory structure involved, the likely cost of goods, the competitiveness and size of the relevant marketplace, and the potential profitability of the Licensed Product, when utilizing sound and reasonable scientific, business and medical practice
and judgment. 
 “Confidential Information” shall have the meaning set forth in Section 10.1. 

“Control” or “Controlled” means, with respect to any item of Information or any intellectual property
right, the possession (other than pursuant to this Agreement) of the right or ability of a Party or any of its Affiliates to grant to the other Party or a Third Party access to and/or a license under such item or right as provided herein without
violating the terms of any agreement or arrangement with any Third Party existing before or after the Effective Date. 

“Deflux Product” means the product containing a biocompatible gel composition formed from polymerized and cross-linked
hyaluronic acid and dextranomer microspheres, wherein the hyaluronic acid is derived from non-animal sources, that is a formulation contained in a disposable syringe, excluding the Deflux needle, as more specifically described on Schedule B attached
to the Ireland Supply Agreement, and as such Schedule B may be amended from time to time in accordance with Section 2.3 of the Ireland Supply Agreement. 
 “Effective Date” means the date of the consummation of the transactions set forth in the SPA. 
 “Establishment License” means Registration number 9710154 and Owner/Operator number 9042143. 
 “European Union” means all members of the European Union, as applicable from time to time. 

  
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 “GAAP” means U.S. generally accepted accounting principles, consistently
applied. 
 “Governmental Authority” means any supranational, national, federal, state, provincial or local
judicial, legislative, executive or regulatory authority. 
 “IDE” means an investigational device exemption or
other application required to be submitted to Regulatory Authorities and be approved or otherwise legally effective before the commencement of any human clinical study of a Licensed Product. 

“Improvements” means any improvement or modification of a then-existing Licensed Product (including new clinical uses of
and modifications to the formulation), whether or not patented, in the Licensed Field. 
 “Information” means
any and all know-how and information, trade secrets, clinical development and other technical and marketing information related to the Licensed Products (whether or not confidential, proprietary, patented or patentable), and all tangible embodiments
of any of the foregoing in written, electronic or any other form, that are necessary or reasonably useful, in the ordinary course of business, for the use, distribution, importation or Commercialization of a Licensed Product in the Territory,
including sales and marketing materials, and medical, clinical, pre-clinical, product development, stability, toxicological testing and other scientific data, relating to the Licensed Products; provided, however, that Information shall not
include information that either Party is under an obligation to unrelated Third Parties not to disclose, such as patient data, and Information shall not include any non-public information from which any manufacturing process employed by or on behalf
of Q-Med in the production of a Licensed Product can be derived by one reasonably skilled in the art and science of medical device, chemical and/or pharmaceutical manufacturing. 

“Ireland Losses” has the meaning given in Section 9.1 below. 

  
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 “Licensed Field” means diagnosis, treatment or prevention of
(a) urological indications including urinary and fecal incontinence, (b) gastroenterology focused indications involving the gastrointestinal tract including umbilical hernia, below, but not including, the vocal chords or (c) any
combination of the foregoing. 
 “Licensed Product” means (a) the Deflux Product and Solesta Product and
all Improvements thereof, and (b) all other biocompatible gel compositions containing polymerized and cross-linked hyaluronic acid, derived from a non-animal source, and dextranomer microspheres, and all Improvements thereof, that, in all such
cases, is a formulation that is capable of being administered by an injection through a needle for use in the Licensed Field. 

“Losses” means Q-Med Losses or Ireland Losses, each as defined below, as the context requires. 

“Major Markets” means Canada and the following countries within the European Union: France, Germany, Spain, Italy and
the United Kingdom. 
 “Manufacture” and “Manufacturing” and other forms of such words means
the manufacturing, processing, filling, handling, storage, packaging and quality control testing (including in-process, raw materials, component, manufacturing product release and stability testing) of Licensed Products. 

“Market Launch” means the first offer of a Licensed Product other than the Deflux Product for commercial sale to the
public following Regulatory Approval. 
 “NASHA Trademark” has the meaning given in Section 2.1(c) below.
For purposes of clarity, the NASHA Trademark shall not be deemed a Q-Med Trademark. 

  
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 “Net Sales” means the gross sales invoiced to Third Parties by Ireland, its
Affiliates or Sublicensees for the Licensed Products in finished packaged form, less the following deductions, in accordance with GAAP (to the extent such amounts are included in the amount invoiced for such Licensed Product and are customary and
reasonable): 
 (a) any refunds for rejects, defects and returned product (including those subject to recall), and trade,
quantity, promotional, early payment and other customary discounts actually allowed and taken directly with respect to such sales; provided, that where any such discount is based on sales of a bundled set of products in which Licensed Product
is included, the discount shall be allocated to such Licensed Product on a pro rata basis based upon the sales value (i.e. the unit average selling price in the prior quarter multiplied by the unit volume) of such Licensed Product relative to the
sales value contributed by the other constituent products in the bundled set, with respect to such sale; 
 (b) any rebates or
chargebacks (including rebates to governmental authorities and managed care organizations); 
 (c) any sales, use, occupation,
or excise taxes, duties or other governmental charges imposed and paid with respect to the sale (including VAT), delivery or use of such Licensed Products (excluding national, state or local taxes based on net income or gross receipts taxes imposed
in lieu of net income taxes); 
 (d) any freight, postage, or transportation insurance charges; and 

(e) wholesaler or distributor fees for physical distribution of Licensed Products. 

Notwithstanding the foregoing, (i) no discount, allowance, rebate, chargeback, or any similar amount, however designated, that is
given or associated with the purchase by the Third Party of any product other than the Licensed Product, or with the purchase or provision of any 

  
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service, shall be taken into consideration in calculating any deductions from the invoiced amount, and (ii) no deductions shall be taken for sales commissions and fees and other marketing
and sales costs. Such amounts shall be determined from the books and records of Ireland, its Affiliates and Sublicensees, all of which shall be maintained in accordance with generally accepted accounting principles, consistently applied. In the case
of any sale of a Licensed Product for consideration other than cash, such as barter or countertrade, Net Sales shall be calculated on the fair market value of the consideration received. For the avoidance of doubt, sales on a named patient basis or
for compassionate use shall be included in Net Sales. 
 For purposes of clarity, in calculating Net Sales of Licensed Products:
(i) to a person who renders any service to a Selling Party, in no event shall the price of the Licensed Product be discounted to reflect any portion of such services, except for incidental distribution services customarily rendered by a seller
of comparable products without charge; and (ii) sold in a bundle with other products, the price shall reflect the discount permitted under Section 5.8 below. 
 “Notified Body” means the certification organization designated by the relevant Member State of the European Union, authorized to conduct conformity assessments in accordance with the
procedures listed in the European Council Directive concerning Medical Devices, 93/42/EEC (OJ No L 169/1, July 12, 1993), as amended. 
 “Old Technology” has the meaning ascribed to the term “Technology” as defined in and as limited by the Biomatrix License Agreement. 

“Prior Agreements” means, collectively: 
 (a) that certain Settlement Agreement dated as of September 28, 1999 by and between Biomatrix, Inc., and Bengt Agerup, Q-Med AB (publ), Medinvent, Qymed Sarl, Q-Med (UK) Ltd., Q-Med GmbH, Q-Med
(Sweden) Australia Pty Ltd., Qvestor AB, Spectra Lab AB, Q-Med Inc., and Q-Med Scandinavia Inc.; 

  
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 (b) that certain License Agreement dated as of September 28, 1999 by and between
Biomatrix, Inc., and Bengt Agerup, Q-Med AB (publ), Medinvent, Qymed Sarl, Q-Med (UK) Ltd., Q-Med GmbH, Q-Med (Sweden) Australia Pty Ltd., Qvestor AB, Spectra Lab AB, Q-Med Inc., and Q-Med Scandinavia Inc. (the “Biomatrix License
Agreement”); and 
 (c) that certain Royalty Agreement dated as of September 28, 1999, by and between by and between
Biomatrix, Inc., and Bengt Agerup, Q-Med AB (publ), Medinvent, Qymed Sarl, Q-Med (UK) Ltd., Q-Med GmbH, Q-Med (Sweden) Australia Pty Ltd., Qvestor AB, Spectra Lab AB, Q-Med Inc., and Q-Med Scandinavia Inc., as each has been amended by that certain
Amendment dated as of September 10, 2004 between and among Genzyme Corporation, as successor in interest to Biomatrix, Inc., and the other parties to each of the foregoing agreements. 

“Q-Med Copyrights” means any published or unpublished work related to Commercialization of the Licensed Products that is
Controlled by Q-Med or any of its Affiliates at any time during the Term. 
 “Q-Med Domain Names” means all
internet uniform resource locators and domain names related to the Commercialization of the Licensed Products that are Controlled by Q-Med or any of its Affiliates at any time during the Term. The Q-Med Domain Names in existence as of the Effective
Date are as set forth on Schedule C hereto. 
 “Q-Med Field” means all uses outside the Licensed Field for:
(a) the Solesta Product and all Improvements thereof; (b) the Deflux Product and all Improvements thereof; and (c) all other biocompatible gel compositions containing polymerized and cross-linked hyaluronic acid, derived from a
non-animal source, and dextranomer microspheres, and all Improvements thereof that, in all such cases, is a formulation that can be administered by an injection through a needle. 

  
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 “Q-Med IP” means the Q-Med Copyrights, Q-Med Domain Names, Q-Med Patents,
the Q-Med Trademarks and the Q-Med Information. 
 “Q-Med Information” means all Information that is Controlled
by Q-Med or any of its Affiliates at any time during the Term. 
 “Q-Med Losses” has the meaning given in
Section 9.2 below. 
 “Q-Med Patents” means the patent and patent applications set forth on Schedule A
and any other patent or patent application in the Territory Controlled by Q-Med or any of its Affiliates at any time during the Term that covers the Licensed Product for use in the Licensed Field, including composition of matter, formulations,
kits, delivery devices, method of manufacturing or use, together with any extensions, reissues, continuations, divisionals, continuations-in-part, reexamination certificates, substitutions or renewals, supplemental protection certificates or
certificates of inventions thereof. 
 “Q-Med Trademarks” means each trademark set forth on Schedule B,
including marks subsequently added by Q-Med and such other trademarks as the Parties may mutually agree. 
 “QMS Supply
Agreement” means the Supply Agreement, dated as of the date hereof, between Q-Med and Q-Med Scandinavia Inc., as the same may be amended or supplemented from time to time in accordance with the terms thereof. 

“Regulatory Approval” means any and all approvals (including any necessary governmental price or reimbursement
approvals), clearances, exemptions, licenses, registrations or authorizations of the applicable Regulatory Authority, necessary for the use, storage, import, promotion, marketing and sale of Licensed Product in the Licensed Field in such
jurisdiction in the Territory, including all CE Marks. 

  
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 “Regulatory Authority” means any competent or other governmental authority
(whether supranational, national, foreign, federal, state, provincial, municipal or other) administrative agency or commission regulating the exportation, importation, use, or Commercialization of medical devices such as Licensed Products in any
jurisdiction within the Territory. 
 “Regulatory Filing” means the relevant application or submission for
Regulatory Approval of a Licensed Product, including a CE Mark in the European Union and all supplements, modifications, amendments, reports, submissions, records and other documents required to be filed with a Regulatory Authority in connection
therewith. 
 “ROW Countries” means all countries in the Territory. “ROW Country” is any of the ROW
Countries. 
 “SEK” means Swedish Krona, the currency currently used in Sweden or the equivalent value in Euro
if the Euro is adopted as the official currency used in Sweden at the official exchange rate. 
 “Solesta PMA Approval
Clinical Trial” means the trial bearing identification number of 33 DA 0404 entitled “Randomized, Subject and Evaluator Blinded, Sham-Controlled, Multi-Center Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal
Incontinence.” 
 “Solesta Product” means the product containing a biocompatible gel composition formed
from polymerized and cross-linked hyaluronic acid and dextranomer microspheres, wherein the hyaluronic acid is derived from non-animal sources, that is a formulation contained in a disposable syringe, as more specifically described on Schedule B
attached to the Ireland 

  
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Supply Agreement, and as such Schedule B may be amended from time to time in accordance with Section 2.3 of the Ireland Supply Agreement. Schedule B includes descriptions of the Solesta
Product (i) as sold by Q-Med on the Effective Date and (ii) as currently being used in the PMA Approval Clinical Trial with respect to the gel composition and as intended to be sold in the U.S. 

“SPA” means that certain Stock Purchase Agreement, dated as of April 22, 2009, entered into between Q-Med and
Oceana Therapeutics LLC. 
 “Sublicensee” means an entity to which Ireland grants a sublicense of its rights
pursuant to Section 2.2 of this Agreement. 
 “Supply Agreements” means the Ireland Supply Agreement and
the QMS Supply Agreement. 
 “Term” shall have the meaning set forth in Section 11.1. 

“Territory” means worldwide excluding the U.S. 
 “Third Party” means any person or entity other than Q-Med, Ireland or their respective Affiliates or Sublicensees. 

“Third Party IP” means any copyrights, domain names, patents and patent applications, trademarks and Information or
other intellectual property rights owned or controlled by a Third Party.  
 “Units” means with respect
to (a) the Solesta Product: a package containing four pre-filled syringes, each containing 1 ml of gel, plus five needles plus a package insert or instructions for use, or such other definition as the Parties shall designate in the event of
modifications to the Solesta Product hereunder or pursuant to the Ireland Supply Agreement; (b) the Deflux Product: a package containing one pre-filled syringe, containing 1 ml of gel, plus a package insert or

  
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 instructions for use, or such other definition as the Parties shall designate in the event of modifications
to the Deflux Product hereunder or pursuant to the Ireland Supply Agreement, (c) other Licensed Products, such other definition as the Parties shall designate. 
 “U.S.” means the United States and its territories and possessions, including Puerto Rico. 
 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” or “including but not limited to” (or “includes without limitation” 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; 
 (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, Schedules and Appendices are to Sections, Articles, Schedules 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 unless the term “Business Days” is used; and 
 (f) Any reference to any supranational, national, federal,
state, local, or foreign statute or law shall be deemed to also refer to all rules and regulations promulgated thereunder, within any jurisdiction or jurisdictions subject thereto unless the context requires otherwise. 

  
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 ARTICLE II 
 LICENSE GRANTS 
 2.1 Grant. Q-Med hereby grants to Ireland:

 (a) the exclusive (including with respect to Q-Med, except to the extent Q-Med retains rights to permit it to perform in
accordance with Section 2.3 below) license under the Q-Med IP to Commercialize, but not to develop or manufacture, the Licensed Products in the Territory for the Term of this Agreement. The exclusive nature of the foregoing license is subject
to the rights granted pursuant to the Prior Agreements with respect to the Old Technology, including U.S. Patent No. 5,633,001. The foregoing license includes the license described in Section 7.1 below. For avoidance of doubt, in no event
shall Ireland have any rights whatsoever outside of the Licensed Field. Ireland may sublicense the rights granted under this Section 2.1(a) only to the extent provided in Section 2.2. 

(b) a royalty-free, nonexclusive license to use the trademark “NASHA” (the “NASHA Trademark”) in accordance
with and subject to the guidelines set forth in Schedule 2.1(b) hereto in connection with the exercise by QMS of the licenses granted in Section 2.1(a) above. 
 2.2 Right to Sublicense. 
 (a) Ireland may sublicense the rights granted
under Section 2.1(a), without any further right of sublicense, only as follows: Ireland may grant a sublicense to an Affiliate without the consent of Q-Med, or to a Third Party upon the consent of Q-Med, which consent may only be withheld if
such Third Party is reasonably determined by Q-Med to be then competing with Q-Med on the date of the grant of the sublicense. Consent of Q-Med shall be 

  
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 deemed given if Q-Med fails to notify Ireland in writing, of its refusal to consent within twenty
(20) days of its receipt of notice of request for consent, accompanied by reasonably detailed and accurate information about the prospective sublicensee. 
 (b) Notwithstanding any sublicense granted hereunder, Ireland shall in all events remain jointly and severally liable to Q-Med for compliance with the terms of this Agreement, including all diligence,
payment and reporting obligations. 
 (c) Ireland shall promptly provide Q-Med with a copy of all provisions of any sublicense
agreement entered into pursuant to this Section 2.2, (which copy may redact financial terms) each of which shall include provisions regarding confidentiality, indemnity, reporting, audit rights, access to data and informational obligations
(collectively “Required Provisions”) no less protective or comprehensive than those set forth in this Agreement and in the Supply Agreement, and which shall name Q-Med as an intended
third party beneficiary of such Required Provisions. No such agreement shall contain any provision purporting or having the effect of mitigating, abating or ameliorating the effect of the Required Provisions, or granting to such sublicensee the
right to grant further sublicenses. All sublicenses granted in violation of this Section 2.2 are void ab initio. 

2.3 Transition Arrangements. 
 (a) Transition Period. The parties shall use Commercially Reasonable Efforts to transfer the existing business of marketing and selling Deflux Products and Solesta Products from Q-Med to Ireland,
and to assist Ireland to obtain all Regulatory Approvals necessary for Commercialization, not later than six (6) months following the Effective Date (“Transition Period”), except as otherwise provided in subsection
(c) below. 

  
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 (b) Q-Med Sales. Upon Ireland’s determination that it has completed transfer of
the existing business of marketing and selling Deflux Products and Solesta Products in a specified territory, Ireland shall so notify Q-Med, which thereupon shall cease all sales and marketing efforts. Until receipt of such notice with respect to
such market, Q-Med shall retain the right to market and sell Deflux Products and Solesta Products in such market, shall continue to manage the marketing and sale of Deflux and Solesta in a manner comparable to its operations prior to the date
hereof, continue to manage the regulatory aspects including continuing the process of obtaining Regulatory Approval for Deflux in Japan, and within ten (10) business days following the end of each calendar month, shall account to Ireland for
all such sales in conformity to the model set forth as Schedule 2.3(b). Q-Med shall pay any amount owed to Ireland as shown in such accounting together with such accounting. To the extent such accounting shows that there is an amount owing by
Ireland to Q-Med, such amount shall be paid within fifteen (15) business days of the delivery of such accounting. 
 (c)
Distribution Agreements. Q-Med and its Affiliates are now selling the Deflux Product in certain countries through Third Party distributors under the arrangements identified in Schedule 2.3(c) (the “Existing Distribution
Arrangements”). Pending the disposal of existing inventory and the transfer, if applicable, of relevant Regulatory Approvals to Ireland or Ireland securing Regulatory Approvals, all Deflux Product and Solesta Product sold in such countries
shall contain the current labeling. As set forth in the SPA, the Parties intend that prior to the consummation of the transactions contemplated by the SPA, Q-Med shall give notice that the rights to distribute Deflux Product and the Solesta Product
under the Existing Distribution Arrangements will be terminated in accordance with the terms of such Existing Distribution Arrangements. 

  
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 (d) All commitments made by Q-Med pertaining to in participation at conferences for the
further commercialization of the Solesta Product and Deflux Product as set forth in Schedule 2.3(d) hereto shall be fully reimbursed by Ireland. All such costs actually incurred by Q-Med will be invoiced by Q-Med. 

2.4 Exclusivity. During the Term of this Agreement: (a) except as expressly permitted in this Agreement, neither Ireland nor
any of its Affiliates shall conduct (nor grant any rights to Third Parties to conduct) any research, development, manufacturing or Commercialization activities, alone or with Third Parties, with respect to injectible bulking agent products for use
in the Licensed Field; and (b) except as expressly permitted in this Agreement, neither Q-Med nor any of its Affiliates shall (i) Commercialize the Licensed Product in the Licensed Field, or (ii) exploit the Solesta or Deflux
trademarks within or outside of the Licensed Field. Notwithstanding the foregoing, nothing herein shall in any way restrict the right of Q-Med to exploit the Q-Med Trademarks to identify itself as the manufacturer and developer of the Licensed
Products. 
 2.5 Improvements. 
 (a) Q-Med. All Improvements Controlled by Q-Med or any of its Affiliates during the Term shall be included under the licenses granted to Ireland under Section 2.1. 

(b) Ireland. To the extent permitted by any contractual arrangement by which Ireland acquires Control of any Improvement, Ireland
hereby grants Q-Med a worldwide, non-exclusive license, to use in the Q-Med Field any Improvements Controlled by Ireland or any of its Affiliates during the Term upon terms and conditions to be mutually agreed upon by the parties. Q-Med may further
sublicense any of its rights granted under this Section 2.5(b) other than to a Third Person reasonably determined by Ireland to be then competing with Ireland. 

  
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 2.6 Reservation of Rights; No Implied Rights. Except as expressly stated herein,
Ireland shall have no other right to use, or interest in, the Q-Med IP or the Licensed Products. 
 ARTICLE III [Intentionally
Omitted] 
 ARTICLE IV 
 REGULATORY 
 4.1 Ireland Regulatory Obligations. Except as set forth
in Section 4.3(b), as between the Parties, Ireland will be responsible for seeking Regulatory Approvals of Licensed Products in the Territory that have not heretofore been obtained and for maintaining all Regulatory Approval of Licensed
Products, in all cases at its expense, and to take all necessary steps appertaining thereto including, in the case of the EU, designating an “authorized representatives” (as defined in Directive 93/42/EEC). Ireland will use Commercially
Reasonable Efforts to compile, submit, and prosecute in a timely manner, all necessary data, documents and Regulatory Filings (including labeling) in a format acceptable to the applicable Regulatory Authorities for those jurisdictions within the
Territory in which Ireland desires to seek Regulatory Approval which shall, in all events, include all of the countries identified as Major Markets. 
 4.2 Q-Med Obligations. Q-Med shall provide to Ireland any information required and reasonably necessary for Ireland to prepare or maintain any Regulatory Approval. 

4.3 Ownership of Regulatory Approvals. 
 (a) Transfer Existing Approvals. Subject to and in accordance with the transition procedures referred to in Section 2.3, Q-Med shall, at its cost and expense, take all actions required to be
taken by a licensor: (i) to enable Ireland to obtain the required CE Marks and (ii) to assign to Ireland the other Regulatory Approvals for the sale of the Solesta Product and the Deflux Product that are held by Q-Med or any of its
Affiliates as of the Effective Date, or 

  
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otherwise enable Ireland to obtain such other Regulatory Approvals existing on the Effective Date. During the Transition Period, Q-Med shall use Commercially Reasonable Efforts to assist Ireland
with the transition procedures regarding Regulatory Approvals described in the immediately preceding sentence without charging any fee for such work. 
 (b) Future Approvals. 
 (i) New Licensed Products. All IDE and other
Regulatory Approvals for the sale of Licensed Products in the Territory during the Term of this Agreement submitted or amended after the Effective Date shall be prepared and submitted by Ireland in its name. In addition, if required in any ROW
Country, such IDEs or Regulatory Approvals shall be submitted by one of the Ireland Affiliates, in the name of Ireland, if permitted, and otherwise in the name of the Ireland Affiliate. 

(ii) Cooperation. Q-Med shall use Commercially Reasonable Efforts to provide Information to Ireland to assist Ireland to respond
to questions from applicable Regulatory Authorities. 
 4.4 Adverse Event Reporting. Promptly after the date hereof, each
Party shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events, and product complaints involving adverse events, sufficient
to permit each Party to comply with its vigilance and medical device reporting and other legal obligations to the appropriate Regulatory Authorities, including, in the case of Q-Med, any such obligations in respect of other products containing
hyaluronic acid that are manufactured or sold by Q-Med and in respect of the activities related to the Licensed Products undertaken by Q-Med pursuant to Section 2.3 during the Transition Period. The safety data exchange procedures will be
promptly updated if required 

  
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by changes in legal requirements or by agreement between the Parties. Ireland shall be responsible for reporting all adverse events to the appropriate Regulatory Authorities in the Territory in
accordance with applicable laws and regulatory requirements and for establishing and maintaining all required files of product complaints and reportable events. Ireland shall ensure that its Affiliates and Sublicensees comply with all such reporting
obligations. 
 ARTICLE V 
 COMMERCIALIZATION 
 5.1 Commercialization and Market Launch. Ireland
shall use Commercially Reasonable Efforts to optimize Commercialization of the Licensed Products in all Major Markets.  

5.2 Performance Requirements and Commercialization Activities for the Deflux Product and Solesta Product and Improvements thereof.

 (a) INTENTIONALLY OMITTED 
 (b) Performance Requirements for the Solesta Product and Improvements. For the initial [*] month period commencing after the [*] anniversary of the Effective Date, Ireland shall achieve Unit sales
goals that shall be no less than [*] during the [*] month period ending on such [*] anniversary date. No later than [*] days prior to the commencement of each subsequent [*] month period, Q-Med and Ireland will in good faith agree upon ROW Country
Unit target sales goals, which target, for the first [*] such periods, shall in no event be lower than the higher of [*] in the immediately preceding period. 
  

	(c)	INTENTIONALLY OMITTED 

  

 

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 21 

 (d) Sales of Deflux Product and Improvements. Commencing on [*] and for each
subsequent [*] month period, and no later than [*], and [*] days prior to the commencement of each such subsequent [*] period, Q-Med and Ireland will in good faith agree upon ROW Country Unit target sales goals for such period, which target, for the
first [*] such periods, shall in no event be lower than [*] Units; provided, however, the [*] Unit sales minimum shall be reduced directly by any corresponding decrease in any Unit sales, compared to Unit sales in the immediately preceding
year, in any ROW Country where a Third Party distribution agreement with Q-Med, Q-Med Polska SP z.o.o., Q-Med International Ltd. or Q-Med (Sweden) Australia Pty. Ltd. is terminated on or about the Effective Date or within the Transition Period
hereunder and not renewed or replaced by Ireland during any such period. 
 (e) INTENTIONALLY OMITTED 

(f) Sales of Other Licensed Products. The Parties will negotiate in good faith the establishment of performance requirements
with respect to Commercialization Activities for other Licensed Products, if any, anywhere in the Territory. 
 5.3 Failure
to Commercialize. 
 (a) Loss of Exclusivity. If Ireland fails in any [*] years to achieve the sales targets set forth
in Section 5.2(b), Q-Med shall have an exclusive right, but not an obligation, at its sole discretion, to convert the license granted under section 2.1 with respect to the Solesta Product and its Improvements into a non-exclusive license for
the balance of the Term in the Territory. If Ireland fails in any [*] years to achieve the sales targets set forth in Section 5.2(d), Q-Med shall have the right (the “Sales Shortage Conversion Right”), but not an obligation, at
its sole discretion, to convert the license granted under Section 2.1, with respect to the Deflux 
  

 

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Product and its Improvements into a non-exclusive license for the balance of the Term in the Territory. Q-Med shall give Ireland at least [*] days’ written notice prior to exercising such
right (“Conversion Date”). Ireland shall thereupon have the right to terminate the Sales Shortage Conversion Right by paying to Q-Med, prior to the Conversion Date, an amount [*]. 

(b) Regulatory Approvals. If at any time a license granted hereunder by Q-Med to Ireland with respect to a Licensed Product shall
cease to be exclusive, Ireland shall take such actions, at the expense of Q-Med, as are within its control as shall be reasonably necessary to enable Q-Med to Commercialize such Licensed Product in the relevant jurisdiction. 

5.4 Marketing Plans. Commencing in October, 2009 and thereafter prior to October 31 of each year, Ireland shall submit to
Q-Med its regularly prepared annual marketing plans for the Licensed Products for the following year, such plans to include plans relating to the pre-launch, Market Launch, promotion and sale of the Licensed Products, including the number of sales
representatives and the general nature of the marketing and advertising campaigns proposed to be conducted (the “Marketing Plans”). The Marketing Plans shall be designed to fulfill Ireland’s undertakings pursuant to this
Article V. 
 5.5 Prohibited Marketing and Sales Activities. 

(a) Ireland shall cause its and its Affiliates’ and permitted Sublicensees’ sales representatives to Commercialize a Licensed
Product only for use in the Licensed Field. For purposes of clarity, Ireland (and its Affiliates and permitted Sublicensees) shall have the right to promote Licensed Products to physicians and medical health care professionals in practice areas
other than gastroenterology and urology, so long as the promotional messages are related to the use of the Licensed Products in the Licensed Field. 
  

 

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 (b) Each Party shall use Commercially Reasonable Efforts to police the Commercialization of
the Licensed Products to ensure that (i) as to Ireland, Licensed Products sold by Ireland, its Affiliates and Sublicensees and distributors are not used outside the Licensed Field, and (ii) as to Q-Med, Licensed Products sold by Q-Med, its
Affiliates and sublicensees and distributors are not used in the Licensed Field (in each of (i) and (ii), an “Out of Field Use”). If either Party believes that Licensed Products have been or are being used or Commercialized for
an Out-of-Field Use, such Party, without limiting its rights or remedies otherwise available under this Agreement, shall present the other Party with such evidence of such Out-of-Field Use available to such Party. Subject to the right to dispute
such claim, the other Party shall use Commercially Reasonable Efforts promptly to cause such Out-of-Field Use to cease. 

5.6 Compliance with Laws. Each Party shall, and shall cause its Affiliates and Sublicensees to, comply in all material
respects with all applicable laws, statutes, rules, regulations, ordinances, and compulsory directives, guidances, policies or pronouncements of law, of any Governmental Authority, including the Medical Device Directive (Directive 93/42/EEC) and the
regulations promulgated pursuant to such laws, and comparable foreign, national, multi-national, supranational, provincial and local laws, statutes, rules, regulations, ordinances and compulsory directives, guidances, policies or pronouncements of
law, of any Governmental Authority (collectively “Laws”) that pertain to the activities for which such Party is responsible under this Agreement or the Supply Agreement, including maintaining in full force and effect or renewing any
permits or applications necessary for such activities (including, in the case of Q-Med, the Establishment License). The termination or expiration of this Agreement shall not relieve either Party of its responsibility to comply in all material
respects with any regulatory requirements associated with Licensed Products. 

  
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 5.7 Marketing and Promotion. Commercialization of the Deflux Products and
Solesta Products by Ireland shall prominently incorporate the Deflux trademark and the Solesta Trademark, as the case may be. To the extent permitted by Law, and if reasonably practicable, all labeling, packaging and promotional materials for the
Licensed Products shall identify Q-Med as the manufacturer and licensor of such Licensed Products. 
 5.8 Discounting.
[*] 
 ARTICLE VI 
 CONSIDERATION 
 6.1 INTENTIONALLY OMITTED 

6.2 Royalties. 
 (a) Ireland shall pay a royalty, following first commercial sale of each Licensed Product by Ireland through the expiration of the last-to-expire issued patent included in the License Agreement and valid
on each market, equal to the percentage shown below of Net Sales of the Licensed Products and Improvements thereof as described below (the “Royalties”) and, thereafter, in accordance with Section 6.4 below. Net Sales shall be
determined on an annual basis separately for direct sales by Ireland, its Affiliates or Sublicensees but shall then be aggregated (see column (A) and the applicable Royalty Rate as set forth in column (B)) as follows: 

 
  

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 Ireland shall pay a fixed royalty per Unit for sales in accordance with the following:

  

			
	
	 Deflux

 

	Unit Sales in the European Union	  	Royalty
	All	  	[*] SEK per Unit
		
	Unit Sales in Canada	  	
	All	  	[*] SEK per Unit
		
	Unit Sales in Japan	  	
	All	  	[*] SEK per Unit
		
	 Unit Sales outside the European

Union, Canada and Japan
	  	
	All	  	[*] SEK per Unit

  

			
	
	 Solesta
  

		
	Unit Sales in the European Union	  	Royalty
	All	  	[*] SEK per Unit
		
	Unit Sales in Canada and Japan	  	
	All	  	[*] SEK per Unit
		
	 Unit Sales outside the European

Union, Canada and Japan
	  	
	All	  	[*] SEK per Unit

 (b) During each [*] calendar month period during the initial [*] following the Effective Date, Unit Gross
Margin Percentage, as defined below, of any Licensed Product sold shall be adjusted to a minimum level of at least [*] in all ROW Countries where Ireland or an Affiliate made sales of Licensed Product as principals to end users, whether through
employees, sales representatives or sales agents, or [*] otherwise (hereinafter the “Unit Gross Margin Minimum”). Unit Gross Margin Percentage shall be defined as (x) the difference between the Net Sales in such applicable ROW
Country during such period and the aggregate Unit Purchase 
  

 

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 26 

 
Price (as defined in the Supply Agreement) of the Units sold in the applicable ROW Country during such period, divided by (y) Net Sales in such applicable ROW Country during such period
(provided, however, in no event for purposes of this subsection (b) (excluding, however, clause (i) below) shall Net Sales in any ROW Country of any Unit of a Licensed Product be deemed less than the per-Unit ASP of such Licensed
Product prevailing during the month preceding the Effective Date). For each ROW Country, in the event that (A) Net Sales (or deemed Net Sales, if applicable) in the applicable ROW Country multiplied by (B) the Unit Gross Margin percentage
is less than (x) the Net Sales (or deemed Net Sales) in the applicable ROW Country multiplied by (y) the Unit Gross Margin Minimum, such shortfall (a “Gross Margin Shortfall”) shall be recovered as set forth below:

 (i) the Royalties payable on actual Net Sales (without taking into account the per-Unit ASP as described above) in the
applicable ROW Country shall be reduced until the Gross Margin Shortfall for such ROW Country equals [*]; or 
 (ii) to the
extent that after the reduction in Royalties pursuant to section 6.2 (b)(i) above, a Gross Margin Shortfall still exists in the subject ROW Country, Ireland shall be entitled to a refund equal to [*]. 

(c) If actual Unit sales in any calendar year were less than the target Unit sales for such year (“Shortage”), Ireland
shall also pay Royalties in respect of the Shortage by multiplying the [*] or [*] by the [*] for all [*], and shall pay such Royalty together with the year-end report delivered under Section 6.5 below. 

 
  

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 Royalties for all other Licensed Products and the term for which such royalties shall be
payable shall be agreed upon by the Parties prior to Commercialization of any such Licensed Product. 
 6.3 Royalty
Term. 
 (a) Royalties shall be payable following the first commercial sale by Ireland of the applicable
Licensed Product, and throughout the Term of this Agreement, subject to reduction pursuant to Section 6.4. 
 (b) Ireland
acknowledges that Q-Med may not own or control patents covering the Licensed Products throughout the Territory and/or throughout the Term of this Agreement, and agrees that in addition to the license under the Q-Med Patents granted to Ireland
pursuant to Section 2.1(a), substantial commercial value has been and will be contributed by the license under Q-Med Information (including know-how) granted to Ireland in Section 2.1(a) and the marketing and branding of Licensed Products
under the Q-Med Trademarks. For their mutual convenience, the Parties have agreed to the royalty rates and payment obligations set forth in Section 6.2, regardless of whether the development, manufacture, use or Commercialization of such
Licensed Products is covered by patents owned or Controlled by Q-Med. 
 6.4 Reduction in Royalties in Certain
Circumstances. Commencing on such date as the Q-Med Patents have expired or have been finally adjudicated invalid by a court of competent jurisdiction with respect to a country within the Territory, and there exists Substantial
Competition in such country from a competitor with a product that in all relevant respects is substantially similar to the Licensed Product, the Parties will in good faith discuss whether there is a need to reduce applicable royalties. As used
herein, “Substantial Competition” means that 

  
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a Third Party is selling a competing bulking agent product in the Licensed Field that has a material adverse effect on Ireland’s sales of such Licensed Product. Ireland shall notify Q-Med in
writing within ten (10) days after Ireland becomes aware of any Substantial Competition. 
 6.5 Reports and
Payments. Commencing immediately with respect to the Deflux Product and otherwise after the Market Launch of any other Licensed Product, within [*] days after June 30, and [*] days after December 31 of each year, Ireland
shall deliver to Q-Med reports true and accurate in all material respects providing the following information on a country-by-country basis and for each Unit size and for the sales tiers set forth in the table in Section 6.2: (a) total
number of Units of each such Licensed Product disposed of by Ireland, its Affiliates or Sublicensees during the [*] months then ended; (b) Net Sales; and (c) Royalties payable. All Royalties shall be payable at the times such reports are
due to Q-Med. The report for the year then ended shall include all information required above on a cumulative basis for such year. 
 6.6 Interest. In addition to any other remedies available to a Party, any required payment hereunder not made on or before the date specified in this Agreement shall bear interest
from the date such payment is due until the date it is actually received by a Party 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 [*]. 
 6.7 Records. Ireland, its
Affiliates and Sublicensees shall, during the Term and for a period of [*] years thereafter, maintain complete and accurate books and records of account relating to the sale of the Licensed Product in the Territory, the achievement of the milestone

  
  

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events in Section 6.1, and the calculation of Net Sales in sufficient detail to permit the accurate calculation of the payments due to Q-Med hereunder and their compliance with and adherence
to the terms and conditions of this Agreement. 
 6.8 Audits. For the sole purpose of verifying the
calculation of Net Sales hereunder, Q-Med shall have the right no more than [*] each year during the Term and for a period of [*] thereafter, to have an independent certified public accountant reasonably acceptable to Ireland examine the relevant
books and records of Ireland and its Affiliates in the location(s) where such records are maintained by Ireland upon reasonable notice and during regular business hours. Results of such examination shall be made available to Ireland. The records and
results of such audits shall be deemed Confidential Information of Ireland. In the event a determination is made that Q-Med has been underpaid or has overpaid, Ireland or Q-Med, as the case may be, shall promptly pay the amount by which Q-Med was
underpaid or overpaid, together with interest thereon as provided in Section 6.6. The fees and expenses of the accountant performing any verification pursuant to this Section 6.8 shall be paid by Q-Med; provided, that, if a
determination is made that the amount paid to Q-Med with respect to any year was less than [*] of the amount properly due to Q-Med, Ireland shall promptly reimburse Q-Med for the reasonable costs, fees and expenses of such examination. 

6.9 Rate of Exchange for Non-SEK Payments. All payments by Ireland to Q-Med under Article VI (including royalties on
sales by Ireland’s Affiliates and Sublicensees) shall be made by Ireland, and such payments, and all calculations of Net Sales, shall be made in SEK. With respect to any Net Sales in currencies other than SEK, the rate of exchange to be used
shall be the average of the commercial rate of exchange on the first Business Day of each quarter and 
  

 

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the last Business Day of such quarter during the applicable time period for making the applicable payment or calculation for the conversion of local currency to SEK as published by Bloomberg
Financial (or a comparable publication to be agreed upon by the Parties). 
 6.10 Taxes. If Ireland or any
of its affiliates is required by Law to withhold and remit any amount 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 Ireland, and Ireland 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 reasonably 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. Q-Med shall, prior to receiving any payment from Ireland or any of its Affiliates provide to Ireland such forms reasonably requested by Ireland to establish any exemption
from or reduction in applicable withholding. Q-Med shall update such forms as reasonably requested or required by law. 

ARTICLE VII 

INTELLECTUAL PROPERTY 
 7.1 Ownership of Q-Med IP. Ireland agrees and acknowledges that: (a) neither Ireland nor its Affiliates or Sublicensees shall have any interest, right, or title in the Q-Med IP,
other than the licenses granted in Sections 2.1 and Article III; (b) neither Ireland nor its Affiliates or Sublicensees shall obtain any rights in or to the Q-Med Trademarks through their use in connection with the Licensed Products, other than
the licenses granted in Section 2.1; and (c) all goodwill associated with or attached to the Q-Med Trademarks arising out of the use thereof by Ireland, its Affiliates and Sublicensees shall inure to the benefit of Q-Med. Q-Med hereby
grants to Ireland the right and license during the Term, subject to Section 7.3 below, to operate one or more websites dedicated to the Commercialization of the Licensed Products using a Q-Med

  
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Trademark as its second-level domain name, provided, an employee or other nominee of Q-Med shall at all times be identified with the domain name registrar as the technical contact and
administrative contact of each uniform resource locator associated with such domain name, and such domain name shall be considered a Q-Med Domain Name. Q-Med agrees to maintain registration for such domain names, at the expense of Ireland.

 7.2 No Contest. Ireland agrees that neither Ireland nor its Affiliates or Sublicensees will, without the consent of
Q-Med: (a) contest, oppose or challenge, or assist any party in contesting, opposing or challenging, Q-Med’s ownership of the applicable Q-Med Trademarks (or the distinctiveness or validity of the applicable Q-Med Trademarks) or the Q-Med
Patents or otherwise take any action or omit to take any action that interferes with Q-Med’s enforcement, exploitation or protection of the Q-Med Trademarks; (b) register or attempt to register any Q-Med Trademark or Q-Med Patents in any
jurisdiction; (c) oppose Q-Med’s registration of any applicable Q-Med Trademark (alone or with other words or designs) in any jurisdiction; or (d) make any application for or register any trademark, service mark, trade name, business
name, domain, URL or any other name, term, design or designation identical, incorporating or confusingly similar to the Q-Med Trademarks for the applicable Licensed Products; or (e) otherwise challenge in any way Q-Med’s ownership,
enforceability or validity of any Q-Med IP. Nothing herein shall preclude Ireland from complying with lawfully issued legal process or requests of Governmental Authorities or for discovery in connection with a Third Party Action, provided Ireland
promptly notifies Q-Med of the service or receipt of such legal process of discovery request and uses Commercially Reasonable Efforts to assist any effort undertaken by Q-Med to quash or limit the scope of such process or request, at Q-Med’s
expense. 

  
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 7.3 Use of the Q-Med Trademarks. Ireland agrees to comply in all material respects
with all Laws pertaining to the proper use and designation of the Q-Med Trademarks and in all use of the Q-Med Trademarks under this Agreement and make Commercially Reasonable Efforts to protect, improve and increase the goodwill and reputation of
the Q-Med Trademarks. Additionally to the extent not prohibited by Law, Ireland, and its Sublicensees, shall: 
 (a) use
Commercially Reasonable Efforts to use the Q-Med Trademarks upon or in relation to the Licensed Products and then only in such manner that the distinctiveness, reputation, and validity of the Q-Med Trademarks shall not be impaired and shall ensure
in particular that each Q-Med Trademark is accompanied by words accurately describing the nature of the goods or services to which it relates; 
 (b) not use any Q-Med Trademark in any proximate relation to vulgar, pornographic, profane or indecent articles, content or materials or in any other context that might reasonably be viewed as impairing
the reputation of the Q-Med Trademark. Ireland may not make any use of the Q-Med Trademark in direct or indirect marketing that is not directly related to the Licensed Field without the prior written consent of Q-Med, which may not be unreasonably
withheld or delayed; 
 (c) display the proper form of trademark and service mark notice associated with the Q-Med Trademarks in
accordance with any reasonable instructions received from Q-Med; 
 (d) include where permissible, on any item which bears a
Q-Med Trademark, a statement identifying Q-Med as the owner of such Q-Med Trademark and where possible indicating that Ireland or its Affiliate or Sublicensee, as applicable, is an authorized user of such Q-Med Trademark, consistent with the
provisions of Section 5.7; 

  
 33 

 (e) not conduct, without the written consent of Q-Med, any part of its business under a
business name or trade name that incorporates any of the Q-Med Trademarks; 
 (f) neither use nor display any of the Q-Med
Trademarks in such relation to any other mark or marks owned by any Third Party or Ireland or its Affiliates as to suggest that the multiple marks constitute a single or composite trademark, service mark, or are under the same proprietorship; and

 (g) to the extent that the use of any of the Q-Med Trademarks violates any controlling law in any jurisdiction within the
Territory, Ireland must not commence nor continue any use it has begun, and shall make reasonable efforts to prevent any use that contravenes controlling laws or mores. 
 7.4 Prosecution and Maintenance. Q-Med shall be responsible, at Q-Med’s sole expense, and shall use Commercially Reasonable Efforts, to prepare, file, prosecute, procure, maintain and defend
(in any interference, revocation, opposition or other proceeding challenging validity) all Q-Med Patents, Q-Med Trademarks and Q-Med Domain Names in (a) the Major Markets and (b) solely with respect to the Q-Med Trademarks, in those
jurisdictions within which Ireland has applied for Regulatory Approval for purposes of Commercializing the Licensed Product in such jurisdiction. Q-Med additionally agrees to use Commercially Reasonable Efforts to maintain and defend all Q-Med
Patents that have issued for which patent registration has been filed on the Effective Date. 

  
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 7.5 Infringement Claims against Third Parties. 

(a) To the extent either Party becomes aware that any of the Q-Med IP is being infringed by a Third Party’s manufacture, importation,
sale, offer for sale or use of a product in the Territory, and such actual or suspected infringement does or is reasonably likely to adversely affect the Commercialization of a Licensed Product (the “Infringement”), the Party first
having knowledge of such Infringement shall promptly notify the other in writing. The notice shall set forth the facts of such Infringement in reasonable detail. 
 (b) If the Infringement is within the Licensed Field (the “Field Infringement”), the Parties shall thereafter consult and cooperate fully to determine a course of action, including the
commencement of legal action by either or both Parties, to terminate any such infringement in accordance with the terms set forth below. If the Infringement is outside the Licensed Field, Q-Med will keep Ireland reasonably informed of the status of
and the activities in any litigation or settlement concerning the Q-Med IP, but Ireland shall have no right to commence or maintain any Action in respect of such Infringement, nor shall Ireland have any right to any proceeds of such Action.

 (c) Q-Med shall have the first right, but not the obligation, to bring an Action or take other appropriate steps in respect
of the Field Infringement. If Q-Med fails to undertake efforts to investigate a Field Infringement within [*] days after it receives a written request from Ireland to do so, or if Q-Med fails to bring an Action to abate a Field Infringement within
[*] days after it receives a written request from Ireland to do so, or if Q-Med notifies Ireland in writing before such periods expire that Q-Med does not intend to take any action, or if Q-Med discontinues the prosecution of any such Action after
filing, Ireland may, in its discretion, and at its cost and expense, undertake such Action as it deems necessary to enforce the Q-Med IP or 
  

 

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Joint Patents in respect of such Field Infringement. In no event shall either Party settle any action referred to in this Section 7.5 with any Third Party if such settlement would materially
affect any of the rights of the other Party (as determined by that Party in its reasonable discretion) under this Agreement, without the prior written approval of the other Party, which approval shall not be unreasonably conditioned, withheld or
delayed. 
 (d) In connection with any Action contemplated under this Section 7.5, the Parties shall cooperate fully and
shall provide each other with any information or assistance that either may reasonably request. Each Party shall keep the other informed of developments in any such Action, including the status of any settlement negotiations and the terms of any
offer related thereto. If the enforcing Party reasonably determines that the other Party is an indispensable party to the Action or it would otherwise be desirable for such other Party to join such Action to obtain a more effective remedy, such
other Party shall consent to be joined. In such event, such other Party shall have the right, at its expense, to be represented in that Action by counsel of its own choice. 
 (e) In an Action with respect to a Field Infringement, all damages, proceeds or other sums of any recovery under such Action related to such Field Infringement, whether by judgment, award or settlement,
shall first be applied to all out-of-pocket costs and expenses, including attorneys fees, incurred by the Party bringing the Action and next shall be applied to all out-of-pocket costs and expenses incurred by the other Party, if any. All remaining
proceeds awarded as compensatory damage shall be considered royalty-bearing Net Sales of Licensed Products and shall be allocated between Q-Med and Ireland pursuant to Article VI above. All other proceeds, including exemplary, statutory or punitive
damages, shall be allocated [*] percent ([*]%) to Q-Med and [*] percent ([*]%) to Ireland. 
  

 

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 ARTICLE VIII 
 REPRESENTATIONS AND WARRANTIES 
 8.1 Q-Med Representations and
Warranties. Q-Med represents, warrants and covenants, as of the Effective Date, that: 
 (a) Q-Med has the legal power and
right to extend the rights granted to Ireland 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 or one or more of its Affiliates is the sole and exclusive owner of, and has all, subject to such rights as have been granted
pursuant to the Prior Agreements, rights, title and interest in and to the Q-Med Patents and the Q-Med Trademarks in the jurisdictions in which such Q-Med Trademarks are registered, free and clear of all liens, security interests, charges,
encumbrances or other adverse claims and Schedule 8.1(c) sets forth a true and complete list of all such Q-Med Trademarks and the jurisdictions in which they are registered; 
 (c) To Q-Med’s knowledge, the clinical trials conducted by Q-Med with respect to the Deflux Product and Solesta Product were performed in accordance in all material respects with all applicable rules
and good clinical practices when they were performed; 

  
 37 

 (d) All issued Q-Med Patents and registered Q-Med Trademarks are in full force and effect,
all fees required to have been paid to maintain the validity of such Q-Med Patents and Q-Med Trademarks have been paid and Q-Med has not taken any action intended to result in the abandonment thereof. 

(e) Except for rights that have expired or were terminated in writing prior to the Effective Date and no longer have any force or effect,
and subject to such rights as have been granted pursuant to the Prior Agreements, Q-Med has not granted a right to any Third Party to market, sell, promote, or distribute in the Territory a Licensed Product for use in the Licensed Field, except the
Existing Distribution Arrangements; 
 (f) None of the Q-Med IP, the Solesta Product or the Deflux Product is the subject of any
notice or claim (including pending or, to Q-Med’s knowledge, unasserted, claims) to Q-Med regarding any infringement, misappropriation or misuse of any Third Party IP, and, to the knowledge of Q-Med, no Third Party is infringing any Q-Med IP in
respect of any manufacture, use or sale of any product or process in the Licensed Field or Q-Med Field; 
 (g) Q-Med has no
knowledge that any issued Q-Med Patents that are part of the Q-Med IP are invalid or unenforceable; and Q-Med has not made any claims, which are now outstanding, against a Third Party alleging infringement of any of the Q-Med Patents or Q-Med
Trademarks in the Licensed Field; 
 (h) Neither this Agreement nor the transactions contemplated hereby shall result in Q-Med
granting to any Third Party any right with respect to any Q-Med IP in the Licensed Field or Q-Med being bound by, or subject to, any non-compete or other restriction on the use of the Q-Med IP in the Licensed Field; 

  
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 (i) 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 regulations relating to the manufacture, use or sale of the Deflux Product or Solesta Product; 

(j) 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; 
 (k) Q-Med 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; 
 (l) Q-Med’s execution, delivery and performance of this Agreement and the Supply
Agreements have been duly authorized by Q-Med and this Agreement and the Supply Agreements will be, upon its execution and delivery, a valid and binding legal obligation of Q-Med, enforceable in accordance with its terms; 

(m) The execution, delivery and performance of this Agreement and the Supply Agreements do 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) of Q-Med, (ii) violate or conflict with any law or governmental order applicable to Q-Med or its

  
 39 

 
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 the assets or properties of Q-Med 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
Q-Med’s shares of capital stock or any of Q-Med’s assets or properties is bound or affected including any and all of the Prior Agreement; and 
 (n) Other than as expressly stated in this Agreement or in connection with any of the Existing Distribution Arrangements, no permit, approval, authorization or consent of any person is required in
connection with the execution, delivery and performance by Q-Med of this Agreement and the Ireland Supply Agreement or the consummation of the transactions contemplated hereby. 

(o) The Deflux trademark and the Deflux Product for use in the treatment of VUR in children in the U.S. does not infringe upon any patent
or trademark rights of any Third Party. To Q-Med’s knowledge, none of the Q-Med IP, the Deflux Product or the Solesta Product infringes upon, misappropriates, or misuses the intellectual property rights of any Third Party. 

  
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 8.2 Ireland Representations and Warranties. Ireland represents, warrants and
covenants, as of the Effective Date, that: 
 (a) Ireland 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; 

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

(c) The execution, delivery and performance of this Agreement do 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) of Ireland, (ii) violate or conflict with any law or governmental order applicable to Ireland 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 the assets or properties of Ireland 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 Ireland’s shares of capital stock or any of Ireland’s assets or properties is bound or
affected; and 
 (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 Ireland of this Agreement or the consummation of the transactions contemplated hereby. 

  
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 8.3 Limitations on Warranties. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 8.1 ABOVE,
Q-MED HEREBY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THE Q-MED PATENTS AND THE LICENSED PRODUCT, EITHER EXPRESS OR IMPLIED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, THERE ARE NO IMPLIED WARRANTIES WHATSOEVER, INCLUDING, WITHOUT LIMTIATION,
THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 
 ARTICLE IX 

INDEMNIFICATION 
 9.1 Q-Med Indemnification. Except to the extent provided in Sections 9.2 and 9.3, and subject to Section 12.1 below, Q-Med shall indemnify, defend and hold harmless Ireland and its Affiliates
and Sublicensees, and its and their respective officers, directors, shareholders, successors, assigns, agents, employees and insurers in such capacity (collectively the “Ireland Indemnified Parties”) from and against any and all
liabilities, claims, damages, losses or expenses (including reasonable attorneys’ and expert fees and expenses incurred by Ireland) solely in respect of Actions against Ireland Indemnified Parties by Third Parties (collectively “Ireland
Losses”) in respect of, without duplication (including any remedy or indemnification under any other agreement between the Parties: 
 (a) the breach by Q-Med of any of its representations, warranties, covenants and other agreements made hereunder; 

  
 42 

 (b) the Commercialization of a Licensed Product by Q-Med, its Affiliates or Third Party
Licensees, including with respect to the Solesta Product or Deflux Product solely occurring prior to the Effective Date, or during the Transition Period; and 
 (c) the infringement, misappropriation or impairment to any Third Party’s intellectual property rights arising out of the exercise by Ireland of the rights to Q-Med IP licensed hereunder (including
any such claims arising out of the Prior Agreements), which exercise, with respect to Q-Med Patents and Q-Med Trademarks, occurred solely in those jurisdictions in which such Q-Med IP is registered or from which it is issued. 

9.2 Ireland Indemnification. Except to the extent provided in Sections 9.1 and 9.3 and subject to Section 12.1 below, Ireland
shall indemnify, defend and hold harmless Q-Med and its Affiliates and its and their respective officers, directors, shareholders, successors, assigns, agents, employees and insurers in such capacity (collectively “Q-Med Indemnified
Parties”) from and against any and all liabilities, claims, damages, losses or expenses (including reasonable attorneys’ and expert fees and expenses incurred by Q-Med) solely in respect of Actions against Q-Med Indemnified Parties by
Third Parties (collectively “Q-Med Losses”) in respect of: 
 (a) the breach by Ireland of any of its
representations, warranties, covenants or other agreements made hereunder; and 
 (b) Ireland’s (or its Affiliates’ or
Sublicensees’) marketing, use, distribution, importation, sale, disposition or other Commercialization activities for Licensed Products. 
 9.3 Limitations on Indemnification. Notwithstanding anything to the contrary set forth elsewhere herein, neither Party shall be obligated to indemnify the other Party under Sections 9.1 or 9.2:
(a) to the extent any indemnifiable Losses thereunder are caused by such 

  
 43 

 
other Party’s, or its Affiliates’, sublicensees’ or assigns’ negligence, intentional misconduct or breach of such other Party’s obligations, warranties or representations
set forth herein; (b) with respect to any claim by a sublicensee, distributor, wholesaler or other person in the business of purchasing products such as a Licensed Product for resale and not for use; or (c) with respect to any Third Party
Action seeking, directly or indirectly, to recover consequential, incidental, punitive or liquidated damages (collectively “Special Damages”) pursuant to contract with a Party, the terms of which fail to exclude the right of such
Third Party to recover such Special Damages, provided, however, to the extent such contract contains such an exclusionary terms but such terms are avoided or annulled in the Third Party Action under applicable principles of law or equity, the
indemnifying Party’s liability shall equal 50% of the Special Damages awarded therein, and, provided further, that none of the provisions of Section 9.1, Section 9.2 or Section 9.3 shall limit any other rights or remedies
either Party may have against the other under this Agreement in respect of such other Party’s negligence, intentional misconduct or breach of any provision of this Agreement except to the extent any claim or remedy is otherwise expressly barred
under the terms of this Agreement. 
 9.4 Procedure. The Party seeking indemnification shall provide the indemnifying
Party with written notice of any claim or action within [*] business days of its receipt thereof, and may issue a notice demanding indemnity prior to the commencement of any claim or action, at any time following its receipt of any written
communication threatening a claim or action, and shall afford the indemnifying Party the right to control the defense and settlement of such claim, action or threatened claim or action. A failure by the Party seeking indemnification to give notice
and to tender the defense in a timely manner pursuant to this Section 9.4 shall not limit the 
  

 

	*	 Confidential treatment requested; certain information omitted and filed separately with the SEC.

  
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obligation of the indemnifying Party under this Article IX, except to the extent such indemnifying Party is materially prejudiced thereby. The Party seeking indemnification shall provide
reasonable assistance to the indemnifying Party in the defense of such claim or action at its own expense. If the defendants in any such action include both Parties, and the indemnified Party concludes that there may be legal defenses available to
it which are different from, additional to, or inconsistent with, those available to the indemnifying Party, the indemnified Party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and the
indemnified Party shall bear the cost and expense of such separate defense, unless and to the extent the Parties otherwise agree or it is determined through dispute resolution hereunder that such costs and expense are or were required to be
indemnified by the indemnifying Party and are or were required to be incurred separately due to such different, additional, or inconsistent defenses. Should the indemnifying Party determine not to defend such claim or action, the indemnified Party
shall have the right to maintain the defense of such claim or action and the indemnifying Party shall provide reasonable assistance to it in the defense of such claim or action and shall bear the reasonable cost and expense of such defense
(including reasonable attorneys’ fees). Neither Party shall settle any such claim or action in a way that prejudices or adversely impacts the other Party without the prior approval of such other Party (which approval shall not be unreasonably
conditioned, withheld or delayed). Following issuance of a notice of demand for indemnity by the indemnified Party, to the extent requested by the indemnifying Party, the indemnified Party must, as soon as reasonably practicable, discontinue any
conduct that forms the basis for the claim or claims in any such action or threatened action. 

  
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 ARTICLE X 
 CONFIDENTIAL INFORMATION 
 10.1 Treatment of Confidential
Information. Ireland agrees to be subject to the terms of a Confidentiality Agreement, dated as of September 25, 2008, between Oceana Therapeutics, Inc. and Q-Med (the “Confidentiality Agreement”), the terms of which are
incorporated herein by reference; provided, however, following the Effective Date, the Confidentiality Agreement will not apply to Ireland’s use of documents and information concerning Oceana Therapeutics LLC and its Affiliates, the U.S.
Business, the ROW Assets and the ROW Liabilities (as such terms are defined in the SPA) (except to the extent that such documents and information contain information related to Q-Med, its post-Effective Date Affiliates or the Licensed Products or
development activities of any of them). Without limiting the effect of the previous sentence, each Party receiving Confidential Information of the other Party shall (a) maintain in confidence such Confidential Information to the same extent
such Party maintains its own proprietary industrial information of similar kind and value (but at a minimum each Party shall use commercially reasonable efforts), (b) not disclose such Confidential Information to any Third Party without prior
consent of the other Party, and (c) not use such Confidential Information for any purpose except for the purpose for which it was disclosed. “Confidential Information” means all non-public, proprietary data or information and
materials received by either Party from the other Party pursuant to this Agreement that are designated as confidential in writing by the disclosing Party. Notwithstanding the foregoing, information that is orally, electronically or visually
disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information of a Party (i) if the disclosing Party, within thirty (30) days after such disclosure, delivers to
the other Party a written document describing the information and referencing the place and date of 

  
 46 

 
such oral, visual, electronic or written disclosure and the names of the persons to whom such disclosure was made, or (ii) such information is of the type that is customarily considered to
be confidential information by persons engaged in activities that are substantially similar to the activities being engaged in by the Parties. Ireland further agrees to cause each person who is member of or who has the right to observe meetings of
its board of directors or other governing body, who is an employee, officer, director, partner, or member of or consultant to an investment company, whether or not registered under the Investment Company Act of 1940, that would be an Affiliate of
Ireland but for the last sentence of the definition thereof, to execute a non-disclosure and confidentiality agreement substantially in the form annexed hereto as Schedule D. 
 10.2 Exceptions. A Party shall not have the obligations set forth in Section 10.1 with respect to any portion of such Confidential Information that it can show by adequate documentation:
(a) is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party; (b) was known to the receiving Party, without obligation to keep it confidential, prior to when it was received from the
disclosing Party; (c) is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential; (d) has been lawfully published by a Third Party; or (e) has been
independently developed by the receiving Party without the aid, application or use of Confidential Information. Information that is otherwise Confidential Information and consists of a combination of information shall not be deemed to be in the
public domain if individual elements of such information are in the public domain, unless the specific combination of those elements is also in the public domain. 

  
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 10.3 Required Disclosures. This Article X shall not be construed to prohibit
disclosure of Confidential Information to the extent that such disclosure is required to by law or valid order of a court or other governmental authority; provided, that the responding Party shall first have given notice to the other Party and shall
have made a reasonable effort to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued. 

10.4 Permitted Disclosures. Nothing contained herein shall prevent either Party from disclosing information to the extent such
information is required to be disclosed (a) for the purposes of Ireland’s compliance with governmental regulations, or (b) to Sublicensees for the purpose of sublicensing; provided, that the Sublicensee is subject to
confidentiality obligations commensurate with those in this Article X. 
 10.5 Disclosure of Financial and Other Terms.
Except as required by applicable laws, treaties, and regulations (including securities laws), the Parties agree that the terms of this Agreement will be considered Confidential Information of both Parties. Notwithstanding the foregoing,
(a) either Party may disclose such terms as are required to be disclosed in its publicly-filed financial statements or other public statements pursuant to applicable laws, regulations, and stock exchange rules (e.g., the U.S. Securities and
Exchange Commission, Nasdaq OMX Nordic Exchange in Stockholm, or any other stock exchange on which securities issued by either Party may be issued) or otherwise disclosed pursuant to applicable law; provided, that (i) the terms of this
Agreement shall be redacted to the greatest extent reasonably possible and (ii) to the extent practicable under the circumstances, such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure
(including any exhibits containing this Agreement) sufficiently in advance of the scheduled release or publication thereof to afford such other Party a reasonable opportunity to review and comment upon the proposed text (including redacted versions
of this Agreement), (b) either Party shall have the further right to disclose the 

  
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material financial terms of this Agreement under confidentiality undertakings to any actual or potential acquirer, merger partner, or providers of financing (whether in the form of debt, equity
or otherwise) and their advisors, and (c) either Party shall have the right to disclose information regarding the development and Commercialization status of the Licensed Products to the extent such disclosure is made under a confidentiality
undertaking to actual or prospective investors, or required by applicable Laws or stock exchange rules. Neither Party shall make any other statement to the public regarding the execution and/or any other aspect of the subject matter of this
Agreement, except: (x) where a Party reasonably believes disclosure is required under applicable laws or ethical commercial practice, (y) for customary discussions with current or prospective investors and analysts, and (z) either
Party may disclose the content of or use the text of a statement previously approved by the other Party or otherwise publicly disclosed in accordance with this Article X. 
 10.6 Publicity. Promptly following the execution of this Agreement, the Parties shall issue a mutually agreed upon press release. Except for subsequent disclosures of substantially similar
information or disclosures required by law, regulation or stock exchange requirements, neither Party shall have the right to make any other public announcements with respect to this Agreement without the prior written consent of the other Party,
which consent shall not be unreasonably withheld, delayed or conditioned, except as provided in this Section 10.6. The Parties agree that any announcement made in respect of this Agreement shall not contain the other Party’s Confidential
Information or, if disclosure of Confidential Information is required by law or regulation, shall make reasonable efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to a government
agency, it being understood that the other Party shall have the right, to the extent in accordance with 

  
 49 

 
applicable law, to review such Party’s disclosures to government agencies and require redaction of any information the other Party reasonably deems inappropriate for disclosure, including
key financial terms not previously disclosed as permitted hereunder. Subject to applicable law and stock exchange requirements, each Party agrees to provide the other Party with a copy of any public announcement as far in advance of its scheduled
release as reasonably practicable and such other Party shall have the right to expeditiously review and recommend changes to any announcement regarding this Agreement; provided, that such right of review and recommendation shall only apply
for the first time that specific information is disclosed and shall not apply to the subsequent disclosure of substantially similar information that has been previously disclosed. 

ARTICLE XI 

TERMINATION 
 11.1 Term. The Term of this Agreement shall expire or terminate co-extensively with the Term of the License Agreement of even date between Q-Med and Q-Med Scandinavia Inc. 

11.2 [INTENTIONALLY OMITTED.] 
 11.3 Termination for Default. If either Party (“Breaching Party”) commits a material breach of a material obligation under this Agreement, the other Party (“Terminating
Party”) may terminate this Agreement. The Terminating Party shall provide written notice to the Breaching Party, which notice shall identify the material breach and the intent to so terminate. The Breaching Party shall have a period of [*]
days ([*] days in respect of any payment default, other than disputes in good faith that are diligently pursued) after such written notice is provided to cure such material breach. If such material breach is not cured within such 

 
  

	*	 Confidential treatment requested; certain information omitted and filed separately with the SEC.

  
 50 

 
[*] (or [*] days as the case may be), or if such material breach is not capable of cure, the Terminating Party may terminate this Agreement, and all of the Breaching Party’s rights
hereunder, upon [*] days written notice to the Breaching Party. To the extent such breach is a material breach by Ireland and relates to its obligations hereunder in one or more countries other than the U.S., but not the entire Territory, and/or is
limited to one or more Licensed Products, but not all of Ireland’s obligations generally, such termination shall apply solely to Ireland’s rights in such country or countries and with respect to such Licensed Product or Licensed Products.
All of the foregoing in this Section 11.3 shall not apply to a failure by Ireland to perform its obligations under Sections 5.2(a)–(d) if Q-Med has exercised its rights under Section 5.3(a) above. 

11.4 Termination Upon Bankruptcy or Insolvency. The Parties agree that in the event a Party becomes a debtor under Title 11 of the
U.S. Code (“Title 11”), this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to rights to “intellectual property” as defined therein. Each Party as a licensee hereunder shall have the
rights and elections as specified in Title 11. Any agreements supplemental hereto shall be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of Title 11. 

11.5 Termination of the Supply Agreement. If either Supply Agreement is validly terminated, the Terminating Party (as defined in
such Supply Agreement) thereunder may terminate this Agreement simultaneously with such termination of such Supply Agreement. 

11.6 Termination for Patent Challenge. If Ireland or any of its Affiliates commences or otherwise, directly or indirectly, pursues
(or voluntarily assists Third Parties to do 
  
  

	*	 Confidential treatment requested; certain information omitted and filed separately with the SEC.

  
 51 

 
so, other than as required by Law or legal process) any proceeding seeking to have any of the Q-Med Patents or other Q-Med IP revoked or declared invalid, unpatentable, or unenforceable, Q-Med
may declare a material breach hereunder and shall then have the right to terminate this Agreement with immediate effect and without further notice or right to cure. 
 11.7 Effect of Termination. 
 (a) Termination of this Agreement, for
whatever reason, shall not affect any rights or obligations accrued by either party prior to the effective date of termination. The following provisions shall survive any expiration or termination of this Agreement: Sections 3.6, 6.7, 6.8, 7.1-7.3,
inclusive, 8.3, Article IX, Article X, this Section 11.7, and Article XII. 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. 
 (b) Upon termination of this Agreement: 

(i) all rights and licenses granted by Q-Med to Ireland shall terminate, except to the extent provided in Sections 11.4; 

(ii) Ireland shall assign or transfer, at Q-Med’s cost and expense, to Q-Med all Regulatory Filings and Regulatory Approvals and
all Information Controlled by Ireland that relates solely to the Licensed Products, or, if such assignment is not legally permissible or such filings, approvals and Information do not relate solely to the Licensed Products, grant Q-Med the exclusive
license and right to access, use, and cross-reference such filings, approvals and Information for the development and Commercialization of the Licensed Products; 
 (iii) Ireland shall assign or otherwise grant, at Q-Med’s cost and expense, all rights required to be assigned or granted under this Section 11.7 promptly and shall promptly (but not later than
sixty (60) days following the effective date of termination) transfer all tangible embodiments to which Q-Med has rights under this Section 11.7; 

  
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 (iv) Ireland shall cooperate, at Q-Med’s cost and expense, in any reasonable manner
requested by Q-Med to achieve a smooth and expeditious transition of the Commercialization of the Licensed Products to Q-Med or its licensees; and 
 (v) Each of Ireland 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 Ireland 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 one archival copy may be retained by each Party’s outside counsel or in-house counsel. 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 11.7(b)(v) 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 X herein. 
 ARTICLE XII 
 MISCELLANEOUS 

12.1 Disclaimers. IN NO EVENT SHALL EITHER PARTY OR THEIR AFFILIATES BE LIABLE FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR THEIR AFFILIATES, 

  
 53 

 
WHETHER BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY; provided, however, the foregoing shall not limit the ability of an indemnified Party to recover indemnity of Special Damages paid
to Third Parties to the extent permitted under Section 9.3 above; and, provided further, nothing in this Section 12.1 is intended to limit Ireland’s payment obligations under Article VI. The Parties agree that the actual,
direct costs incurred to perform development or Commercialization obligations hereunder that the other Party was obligated but failed to perform (subject to the right of such other Party to cure) shall be deemed to be direct damages and not subject
to this limitation. 
 12.2 Governing Law; Jurisdiction, Arbitration and Venue. This Agreement and the exhibits and
schedules hereto shall be governed by and interpreted and enforced in accordance with the substantive laws of the State of New York, without giving effect to any choice of law or conflict of laws rules or provisions (whether of the State of New York
or any other jurisdiction) that would cause the application of the substantive laws of any jurisdiction other than the State of New York, except that questions affecting the construction and effect of any patent or trademark shall be determined by
the law of the country in which the patent or trademark was granted. Any dispute, controversy or claim arising out of or in connection with this contract, or the breach, termination or invalidity thereof, shall be finally settled by arbitration in
accordance with the Arbitration Rules of the Arbitration Institute of the Stockholm Chamber of Commerce. The arbitral tribunal shall be composed of three (3) arbitrators. The seat of arbitration shall be Stockholm. The language to be used in
the arbitral proceedings shall be English. The foregoing notwithstanding, either Party may commence an Action to seek declaratory or equitable relief to enjoin a breach of threatened breach of this Agreement, which Action shall be brought solely in
the United States District Court for the Southern District of New York. 

  
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 12.3 Consent to Jurisdiction. EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY
(A) SUBMITS, FOR ITSELF AND ITS PROPERTY, TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK WITH RESPECT TO ANY CLAIM SEEKING DECLARATORY OR EQUITABLE RELIEF ARISING UNDER OR RELATING TO
THIS AGREEMENT; PROVIDED, HOWEVER, THAT SUCH CONSENT TO JURISDICTION IS SOLELY FOR THE PURPOSE REFERRED TO IN THIS SECTION 12.3 AND SHALL NOT BE DEEMED TO BE A GENERAL SUBMISSION TO THE JURISDICTION OF SAID COURT OR IN THE STATE OF NEW
YORK OTHER THAN FOR SUCH PURPOSE, (B) WAIVES PERSONAL SERVICE OF ANY AND ALL PROCESS UPON IT, (C) CONSENTS THAT ALL SERVICES OF PROCESS BE MADE BY REGISTERED OR CERTIFIED MAIL, RETURN RECEIPT REQUESTED, DIRECTED TO IT AT ITS ADDRESS AS SET
FORTH IN SECTION 12.6, AND (D) ACKNOWLEDGES THAT SERVICE SO MADE SHALL BE TREATED AS COMPLETED WHEN RECEIVED. EACH PARTY HERETO IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE BASED ON
FORUM NON CONVENIENS AND WAIVES ANY OBJECTION TO VENUE OF ANY ACTION INSTITUTED HEREUNDER. NOTHING IN THIS SECTION SHALL AFFECT THE RIGHT OF ANY PARTY HERETO TO SERVE LEGAL PROCESS IN ANY OTHER MANNER PERMITTED BY LAW. 

  
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 12.4 Assignment. Neither this Agreement nor any of the rights and obligations arising
hereunder may be assigned or transferred by either Party by merger, sale of stock or assets, operation of law or otherwise, without the prior written consent of the other Party, which shall not be unreasonably conditioned, withheld or delayed;
provided, however, that (a) Ireland may assign this Agreement without such consent in connection with the sale or transfer of all or substantially all of the business or assets relating to or associated with the Licensed Field to any
Third Party, whether by merger, sale of stock or assets, operation of law or otherwise, provided that such assignment occurs in connection with a substantially contemporaneous permitted assignment of all of the rights and obligations of Q-Med
Scandinavia Inc. (“Scandinavia”) under that certain license agreement between Q-Med and Scandinavia of even date (“U.S. License Agreement”), to the same assignee, (b) at least 65% of the voting stock of Ireland
(“Ireland Control Stock”) or Ireland’s interest in this Agreement may be collaterally pledged without such consent to a financial institution or syndicate of financial institutions represented by a single lenders’ agent to
secure obligations to such lender(s) in connection with a bona fide financing (the “Ireland Pledge”) which pledge will include the right of the lender(s) and their assigns to foreclose upon such pledge, provided that such
pledge occurs in connection with a substantially contemporaneous permitted pledge of the U.S License Agreement or of all of the voting stock of Scandinavia to the same lenders represented by the same lenders’ agent (the “U.S.
Pledge”), and, provided further that, notwithstanding any other provision hereof, unless such lenders foreclose upon both the QMS Pledge and the Ireland Pledge, and at all times after any such foreclosure the assignee of
Scandinavia’s interest in the U.S. License Agreement (whether directly or as assignee of all of the voting stock of Scandinavia) is also the owner of the Ireland Control Stock or an affiliate thereof, this Agreement shall immediately terminate
upon 

  
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 notice thereof from Q-Med to Ireland, and (c) Q-Med may assign this Agreement without such consent to
any Third Party which acquires all or substantially all of Q-Med’s NASHA DX business, whether by merger, sale of stock or assets, operation of law or otherwise provided that such assignment occurs in connection with a substantially
contemporaneous permitted assignment by Q-Med of the U.S. License Agreement to the same assignee. Any attempted assignment, sale or transfer in violation of the prior sentence will be void. Upon any permitted assignment or transfer of this Agreement
by either Party, (i) the other Party shall be given prompt written notice of such assignment and (ii) the assignee shall agree in writing to be bound by the terms and conditions set forth herein. Notwithstanding the foregoing, either Party
may assign this Agreement 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. 
 12.5 Change of Control. 

(a) Definition of Change of Control. For the purpose of this Section 12.5, “Change of Control” means:
(i) a sale to a Third Person reasonably determined in good faith by Q-Med to be then competing with Q-Med of all or substantially all of Ireland’s assets; (ii) a merger, reorganization or consolidation involving Ireland or any of its
Affiliates and such Third Person in which the stockholders or any Affiliate of Ireland immediately prior to such transaction cease to own, directly or indirectly, collectively a majority of the voting or equity rights or interests of a successor
entity to Ireland; or (iii) the acquisition, directly or indirectly through one or more Affiliates, by such Person or group of Persons (including such Third Person reasonably determined in good faith to be competing with Q-Med) acting in
concert of 50% or more of the voting or equity rights or interests of Ireland. 

  
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 (b) Effect of Change of Control. Upon the Change of Control, Q-Med may
terminate all rights to any Improvements that are thereafter acquired or developed by Q-Med. 
 12.6 Notice. Any
notice to be given by one Party to the other shall be in writing and shall be deemed given when delivered personally (such notice to be effective on the date of delivery) or sent by reputable international courier (such notice to be effective on the
date which is three (3) Business Days after the date of delivery to such courier), 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 

SE-752 28 Uppsala 
 Sweden 
 Attention: Director Legal Affairs 

Telephone: +46 18 474 90 00 
 Facsimile: +46 18 474 90 97 
 With a copy to (which shall not constitute notice
for purposes hereunder): 
 Michael Martell, Esq. 
 Morrison Cohen LLP 
 909 Third Avenue, 27th Floor 

New York, New York 10022 
 USA 
 Telephone: +01 212 735 8652 

Facsimile: +01 212 735 8600 

  
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 If to Ireland: 
 Oceana Therapeutics LLC 
 2035 Lincoln Highway 

Edison, NJ 08817 
 USA 
 Attention: Steven M. Bosacki 

Telephone: +1 732-318-3811 
 Fax: +1 732-318-3801 
 With a copy to (which shall not constitute notice for
purposes hereunder): 
 Milbank, Tweed, Hadley & McCloy LLP 

One Chase Manhattan Plaza 
 New York, NY 10005 
 USA 

Attention: Robert S. Reder, Esq. 
 Telephone: +1 212-530-5680 
 Fax: +1 212-822-5680 

12.7 Force Majeure. Neither Party shall be responsible or liable in any way for failure or delay in carrying out the terms
of this Agreement (other than any payment or confidentiality obligations) resulting from any cause or circumstance beyond its reasonable control, including acts of God, embargoes, fire, flood, other natural disasters, war, labor difficulties,
interruption of transit, accident, explosion, civil commotion, delays in performance or supplies from its suppliers and subcontractors (where such delays in performance or supplies are attributable to an event of force majeure suffered by such
supplier or subcontractor) and acts of any governmental authority (“Force Majeure”); provided, that the Party so affected shall give prompt notice thereof to the other including the period for which the Force Majeure is
expected to continue . Any time for performance hereunder (other than any time for payment) shall be extended by the actual time of delay caused by the Force Majeure event. Except as provided in the preceding sentence, no such failure or delay shall
terminate this Agreement, and each Party shall use its Commercially Reasonable Efforts to mitigate any damages incurred by the other Party as a result of the Force Majeure event and to complete its obligations hereunder as promptly as reasonably
practicable following cessation of the cause or circumstances of such failure or delay. 

  
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 12.8 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. 
 12.9 Entire Agreement. This Agreement together with the Ireland Supply Agreement and the Quality 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, representations or understandings of
the Parties relating thereto. There are no other representations, oral or written, except as set forth herein, or when the Parties are relying to enter into this Agreement. 
 12.10 Severability. The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any
controlling body of the law in any jurisdiction or jurisdictions within the Territory, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement in such jurisdiction,
provided that the essential purpose of this Agreement is not frustrated. 
 12.11 Expenses. Q-Med and
Ireland will each bear their own expenses and the expenses of their respective Affiliates incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations
contemplated hereby. In connection with any Action brought to enforce or invalidate any right or obligation arising hereunder, the Party against whom a judgment is entered shall, in addition to any other remedy awarded, be obligated to pay the
prevailing Party all costs and expenses of its prosecution or defense of such Action, including attorneys’ fees. 

  
 60 

 12.12 Further Actions. Q-Med and Ireland 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. 
 12.13 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 Ireland 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 Ireland 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. 
 12.14 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. 
 12.15 No Third Party Rights. Other than with respect to the rights of the Q-Med Indemnified Parties and the Ireland Indemnified Parties, 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. 

  
 61 

 12.16 Construction. This Agreement will be deemed to have been drafted by both Q-Med
and Ireland and will not be construed against either Party as the draftsperson hereof. 
 12.17 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. 

12.18 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. 
 12.19 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. 
 12.20 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.

 [Remainder of Page Intentionally Left Blank] 

  
 62 

 IN WITNESS WHEREOF, the Parties execute this Agreement as of the Effective Date.

  

									
	Q-MED AB	 		 	CETACEA LIMITED
					
	By:	 	 /s/ Bengt Agerup
	 		 	By:	 	 /s/ Michael Greene

	Name:	 	Bengt Agerup	 		 	Name:	 	Michael Greene
	Title:	 	CEO	 		 	Title:	 	Director
					
		 		 		 	By:	 	 /s/ Fergus McLoughlin

		 		 		 	Name:	 	Fergus McLoughlin
		 		 		 	Title:	 	Director

 [Signature Page – Ireland License Agreement] 

  
 63 

 SCHEDULE A 

[*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

  

 SCHEDULE B 

[*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

  

 SCHEDULE C 

[*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

  

 SCHEDULE D 

STRICTLY CONFIDENTIAL 
 FORM OF CONFIDENTIALITY AGREEMENT 
 (Individual) 

CONFIDENTIALITY AGREEMENT, dated as of             , 2009 (this
“Agreement”), by and between from Q-Med AB, a company formed under the laws of Sweden (the “Company”), and [INDIVIDUAL], an individual located at [ADDRESS OF INDIVIDUAL] (the
“Recipient”). 
  

	 	A.	WHEREAS, pursuant to a Stock Purchase Agreement (the “Purchase Agreement”) dated as of April [    ], 2009, [Oceana
Therapeutics LLC], a Delaware limited liability company (“Buyer”), has acquired the stock of Q-Med Scandinavia Inc., a Delaware corporation (“QMS”), from the Company. 

 

	 	B.	WHEREAS, after giving effect to the acquisition contemplated by the Purchase Agreement, the Company has and will continue to develop and manufacture certain products
and, as a result, pursuant to a Supply Agreement to be entered into between Buyer and the Company (the “Supply Agreement”), Buyer and certain of its affiliates have had and will continue to have access to certain non-public,
proprietary information of the Company. 

  

	 	C.	WHEREAS, as a condition to the Company entering into the Purchase Agreement, the Company is requiring that certain persons, including Recipient, who is or will become a
member of or observer to the board of directors or board of managers of Buyer or any of its subsidiaries (including, without limitation, QMS), enter into this Agreement to ensure that certain proprietary information remain confidential and retains
its commercial value. 

 NOW, THEREFORE, in consideration of the foregoing premises and the respective
representations and warranties, covenants and agreements contained herein, the parties hereto agree as follows: 
 1.
Definitions. For purpose of this Agreement, the following terms shall have the following meanings: 
 a.
“Commercialization” means any and all activities directed to: (i) marketing, promoting, distributing, importing, offering to sell and/or selling the Products, including market research, seeking appropriate reimbursement, billing and
coding support for physicians and clinics, product related public relations, planning, detailing, marketing, distribution, creative development of visual sales aids, direct mail, telemarketing and teledetailing, media placement and advertising,
field marketing events, and sales meetings; and (ii) medical affairs support (including medical education programs, medical meetings and educational grants), regulatory affairs and quality assurance support (including adverse event reporting
and post-market surveillance studies, whether for marketing purposes, post-marketing experience investigations, regulatory compliance or as a condition to obtaining, maintaining or amending a regulatory approval). 

 b. “Confidential Material” shall mean any and all Confidential Information, as
that term is defined in the License Agreement by and between the Company and QMS. “Confidential Material” does not include information (i) that is or becomes generally available to the public other than as a result of an act or
omission by Recipient or any of its Representatives, (ii) that Recipient receives or has received on a non-confidential basis from a source other than the Company or any of its Representatives, provided that such source is not known to
Recipient to be subject to a contractual, legal, fiduciary or other obligation of confidentiality with respect to such information or (iii) information which is independently developed, discovered or arrived at by such Recipient without use of
Confidential Material. 
 c. “Licensed Field” means diagnosis, treatment or prevention of (i) urological
indications including urinary and fecal incontinence, (ii) gastroenterology focused indications involving the gastrointestinal tract including umbilical hernia, below, but not including, the vocal chords or (iii) any combination of the
foregoing. 
 d. “Product” means any and all biocompatible gel compositions containing polymerized and cross-linked
hyaluronic acid, derived from a non-animal source, and dextranomer microspheres, and all improvements thereof, that, in all such cases, is a formulation that is capable of being administered by an injection through a needle for use in the Licensed
Field. 
 e. “Representative” means any employee, officer, director, manager, partner, agent, advisor, consultant,
representative or nominee. 
 2. Non-Disclosure; Non-Use. Recipient hereby agrees that the Confidential Material will be
kept confidential and that Recipient will not disclose any of the Confidential Material to any other person and will not use the Confidential Material other than solely in connection with satisfying Recipient’s lawful obligations as a member of
or observer to the board of directors (or equivalent governing body) of the Buyer or any of its subsidiaries (including, without limitation, QMS), as applicable. In any event, Recipient agrees to undertake precautions to safeguard and protect the
confidentiality of the Confidential Material. 
 3. Permitted Disclosure. In the event that Recipient is requested or
required (by oral questions, interrogatories, requests for information or documents in legal, administrative, regulatory or other similar proceedings; subpoena, civil investigative demand or other similar process) to disclose any of the Confidential
Material, Recipient shall provide the Company with prompt written notice of any such request or requirement so that the Company may in its sole discretion seek a protective order or other appropriate remedy and/or waive compliance with the
provisions of this letter agreement. If, in the absence of a protective order or other remedy or the receipt of a waiver by the Company, Recipient is nonetheless legally compelled to disclose Confidential Material, Recipient may, without liability
hereunder, disclose only that portion of the Confidential Material which is legally required to be disclosed, provided that Recipient use reasonable efforts to preserve the confidentiality of the Confidential Material, including, without
limitation, by using commercially reasonable efforts to cooperate with the Company, at the Company’s sole expense, to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded the
Confidential Material. 

 4. Injunctive Relief. It is further understood and agreed that money damages would
not be a sufficient remedy for any breach of this Agreement by Recipient and that the Company shall be entitled to equitable relief, including, without limitation, injunction and specific performance, as a remedy for any such breach. Such remedies
shall not be deemed to be the exclusive remedies for a breach by Recipient of this Agreement but shall be in addition to all other remedies available at law or equity to the Company. Recipient further agrees not to raise as a defense or objection to
the request or granting of such relief that any breach of this agreement is or would be compensable by an award of money damages and agree to waive any requirements for the securing or posting of any bond in connection with such remedy. 

5. Waiver. It is understood and agreed that no failure or delay by the Company in exercising any right, power or privilege
hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or future exercise thereof or the exercise of any other right, power or privilege hereunder. 

6. Term; Reasonableness of Restrictions. Recipient’s obligations under this Agreement shall continue indefinitely and shall
survive any termination hereof. Recipient acknowledges and agrees that the restrictions contained herein are reasonable and necessary to protect the confidentiality and value of the Confidential Material and that Recipient will receive a benefit by
having access thereto. 
 7. Miscellaneous. 
 a. This Agreement is for the benefit of the Company (and its subsidiaries and affiliates), and shall be governed by and construed in accordance with the laws of the state of New York applicable to
agreements made and to be performed entirely within the state of New York, without giving effect to New York principles or rules of conflict of laws to the extent such principles or rules would require or permit the application of the laws of
another jurisdiction. The parties hereby irrevocably and unconditionally consent to submit to the exclusive jurisdiction of the courts of the state of New York for any actions, suits or proceedings arising out of or relating to this agreement and
the transactions contemplated hereby (and the parties agree not to commence any action, suit or proceeding relating thereto except in such courts, and further agree that service of any process, summons, notice or document by U.S. registered mail to
your address set forth above shall be effective service of process for any action, suit or proceeding brought against you in any such court). The parties hereby irrevocably and unconditionally waive any objection to the laying of venue of any
action, suit or proceeding arising out of this agreement or the transactions contemplated hereby in the courts of the state of New York, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. 
 b. This Agreement
contains the entire agreement between us and you regarding its subject matter and supersedes all prior agreements, understandings, arrangements and discussions between Recipient and the Company regarding such subject matter. 

c. No provision in this Agreement can be waived or amended except by written consent of the Company, which consent shall specifically
refer to this paragraph (or such provision) and explicitly make such waiver or amendment. 

 d. This Agreement may be signed by facsimile and in one or more counterparts, each of which
shall be deemed an original but all of which shall be deemed to constitute a single instrument. 
 [Signature page
follows] 

 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by
their respective authorized officers as of the date first above written. 
  

									
	RECIPIENT	 	 	 	 COMPANY

			
		 		 	Q-MED AB
				
	  
	 		 	By:	 	  

	[NAME OF RECIPIENT]	 		 	Name:	 	
		 		 		 	Title:	 	

 [Signature Page – Ireland License Agreement] 

 SCHEDULE 2.1(c) 

NASHA Trademark User Instructions 
 The Deflux® and SolestaTM products are manufactured using
Q-Med’s patented NASHATM technology for the production of the stabilized non-animal hyaluronic acid, also used in all other Q-Med products. The word mark “NASHA” and the design mark depicted at the bottom of this document are both
trademarks owned by Q-Med AB. 
 NASHA Word Mark 
 Instructions for Use 
 In all use of the trademark NASHA, QMS shall clearly indicate that
NASHA is a trademark owned by Q-Med and in using the trademark follow the below instructions. 
  

	 	•	 	 NASHA may only be used in direct conjunction with Deflux and Solesta. 

 

	 	•	 	 In the use of NASHA, in conjunction with Deflux and Solesta, NASHA shall always have a clear function as the trademark for the technology and/or the
gel that is manufactured using the technology, on which Deflux and Solesta are based. 

  

	 	•	 	 NASHA may not be used separately or out of context. 

  

	 	•	 	 Never indicate or imply that NASHA is an acronym or abbreviation of non-animal stabilized hyaluronic acid, or that it “means” stabilized
non-animal hyaluronic acid. If NASHA needs to be “explained”, write: “NASHATM is a patented technology for the production of stabilized non-animal hyaluronic acid” or equivalent. Always write: “stabilized non-animal
hyaluronic acid” and not “non-animal stabilized hyaluronic acid”, in order to avoid the use of NASHATM as an acronym/abbreviation. 

  

	 	•	 	 Always write NASHA in uppercase letters. 

  

	 	•	 	 NASHA with the affixed
® symbol may be used in countries where NASHA has been registered as a trademark. In all other countries, the
TM symbol shall be used, including countries where a trademark application is pending. Use TM also for material intended for international use, if such use includes both countries in which NASHA is registered and countries where it is not.
For status on trademark applications and registrations as of the [DATE], please see Exhibit [INSERT] to the [License Agreement]. 

	 	•	 	 The first time NASHA is used on every page of a document or website, use either TM or ® to alert the reader that NASHA is a trademark, like this: “NASHATM” or “NASHA®”. 

  

	 	•	 	 All use of the NASHA trademark shall be accompanied by the wording “NASHATM/®
, is a trademark licensed to QMS Therapeutics, Inc. by Q-Med AB (publ)”, somewhere in the same document. 

 Examples of Acceptable Use 
 NASHA may be used as an adjective, like this: “NASHATM
gel”, “NASHATM technology” or “patented NASHATM technology”. The following phrases are examples of acceptable use of the trademark and may provide guidance. 

 

	 	•	 	 “The
Deflux® product is based on NASHATM gel, consisting of stabilized hyaluronic acid and dextranomer
microspheres.” 

  

	 	•	 	 “The NASHATM gel in SolestaTM includes dextranomer.” 

 

	 	•	 	 “NASHATM gels are produced using a patented biotechnological method and hyaluronic acid of high purity from a non-animal (bacterial) source.
The unique stabilization process used to manufacture the NASHA gel prolongs its residence time (half-life) within the body. NASHA gel contain only the minimum number of cross-links needed to ensure that almost every hyaluronic acid molecule in the
network is connected to another molecule. The structure of the hyaluronic acid in NASHA gels is therefore almost identical to that found in the body, as only about 1% of the molecule is modified.” 

 

	 	•	 	 “NASHATM Gel Half-Life (head line) – The residence time of NASHA gels depends on the size of the gel beads, the degree of hyaluronic acid
cross-linkage, the concentration of stabilized hyaluronic acid in the gel and the presence of inflammatory reactions in the area where it is injected.” 

 

	 	•	 	 “The manufacturing of NASHATM gel is performed under controlled conditions at Q-Med AB, Uppsala, Sweden. The manufacturing includes the
stabilization of hyaluronic acid to form NASHA gel.” 

  

	 	•	 	 “The hyaluronic acid used in the manufacture of NASHATM is biosynthesized from a non-animal source.” 

 

	 	•	 	 “In NASHATM gel, a very low degree of stabilization (less than 1%) has proven sufficient to obtain a product with the desired
properties.” 

  

	 	•	 	 “Q-Med has created the NASHATM technology, a science-based technological platform that makes it possible to design products with special
properties to address different intended uses and patient needs. 

  

	 	•	 	 “The hospital healthcare segment includes products based on NASHATM gels containing dextranomer beads for use in the treatment of urinal and
fecal incontinence.” 

 NASHA Design Mark 
 QMS may only use the design mark (depicted below) on the Deflux and Solesta products labelling as provided by Q-Med under the Supply Agreement. For use in any other context QMS shall acquire Q-Med’s
prior approval in each case. 
  
 

 

  

 SCHEDULE 2.3(b) 
 ROW DEFLUX & SOLESTA 
  

 
 “Month & Year”

  

									
	  	  	Month To Date	  	Year To Date
	 (KSEK)
	  	Deflux	  	Solesta	  	Deflux	  	Solesta
	 NET SALES 
	  		  		  		  	
	 Cost of goods sold
	  		  		  		  	
		  	  
	  	  
	  	  
	  	  

	 GROSS PROFIT
	  		  		  		  	
	 Sales Costs
	  		  		  		  	
	 Marketing Costs
	  		  		  		  	
	 Admin & Regulatory Costs
	  		  		  		  	
	 Depreciation M&S exp.
	  		  		  		  	
		  	  
	  	  
	  	  
	  	  

	 TOTAL EXPENSES
	  		  		  		  	
	 OPERATING INCOME
	  		  		  		  	

  

 SCHEDULE 2.3(c) 

[*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 SCHEDULE 2.3(d) 

1. PUNC (Pediatric Uronephrologic Center), 2009 meeting on VUR, June 4-6 in Gothenburg, [*] 

2. SPUS (Society of Pediatric Urologic Surgeons), 2009 meeting, September 10-12 in Canada, [*] 

3. EUPSA (European Paediatric Surgeons’ Association), 10th EUPSA CONGRESS 2009 together with the 56th Annual Congress of the British
Association of Paediatric Surgeons, June 17th - June 20th, 2009 in Graz, Austria, [*] 
 4. ESPU (European Society for
Paediatric Urology) 20th Anniversary Congress of the ESPU, May 6-9, 2009 in Amsterdam, the Netherlands, [*] 
 5. ESCP
(European Society of Colo Proctology), 4th Scientific Meeting, Wednesday 23 - Saturday 26 September 2009, Prague Congress Centre, [*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

  

 SCHEDULE 8.1(c) 

[*] 
  

 

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC.Supply Agreement (between Q-Med AB and Q-Med Scandinavia)

 Exhibit 10.89 
 Portions of this exhibit marked [*] are omitted and 
 are requested to be treated
confidentially. 
 Execution Copy 
  

 
  

SUPPLY AGREEMENT 
 BETWEEN 
 Q-MED SCANDINAVIA
INC. 
 AND 
 Q-MED AB 
  

 
  

 SUPPLY AGREEMENT 

This Supply Agreement (this “Agreement”) is entered into as of June 2, 2009 between Q-MED SCANDINAVIA INC.,
a corporation organized under the laws of Delaware (“QMS”), and Q-MED AB, a company organized under the laws of the Kingdom of Sweden with corporate registration number 556258-6882 (“Q-Med”). Each of Q-Med
and QMS shall be referred to herein as a “Party” and collectively as the “Parties.” 

BACKGROUND 
 QMS has been granted, pursuant to the License Agreement (as defined herein), rights to sell the Licensed Products (as defined in the License Agreement), including the Deflux® and Solesta® Products (as defined in the License Agreement). In connection with entering into the License Agreement, Q-Med has agreed to supply QMS and its Affiliates and
Sublicensees (each as defined in the License Agreement) with the Licensed Products, and Q-Med and QMS desire to define in this Agreement their respective rights and obligations with regard to the supply of the Licensed Products. 

The Parties agree as follows: 

ARTICLE I. 

DEFINITIONS 
 1.1 Definitions. For the purposes of 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 License Agreement: 
 “Agreement” means this Agreement and all schedules and exhibits attached
hereto, as the same may be amended or supplemented from time to time in accordance with the terms hereof. 

 “Clinical Testing Products” means any Licensed Product to be used in
clinical trials to support Regulatory Approval or for other pre- or post-market studies in the Territory, approved by the JSC and having the Specifications set forth in the applicable IDE, PMA Application or Regulatory Approval. 

“Deflux Product” means the product as specifically described on Schedule B hereto, as Schedule B may be amended from
time to time in accordance with Section 2.3 of this Agreement. 
 “Delivery of Licensed Products to QMS”
or similar wording means the point in time when Licensed Products are delivered to QMS or its agent at the Facility or any New Facility. 
 “Effective Date” means the date of the consummation of the transactions set forth in that certain Stock Purchase Agreement, dated April 22, 2009, entered into between Q-Med and
Oceana Therapeutics, LLC. 
 “Facility” means Q-Med’s facilities located in Uppsala, Sweden, used in
connection with the Manufacturing activities. 
 “Firm Order” means an irrevocable purchase order for Licensed
Products that shall set forth (a) the quantity of each article number of each Licensed Product ordered (indicating separate quantities for each label and each Unit size) on a monthly basis, and (b) a delivery schedule specifying the
monthly delivery date for each Licensed Product ordered and the shipment destination(s), as submitted in each Forecast in accordance with Section 2.2(a). 

  
 2 

 “Full Manufacturing Costs” means Q-Med’s Manufacturing costs as
determined by reference to Q-Med’s standard operating and accounting procedures. 
 “GMP” means current
Good Manufacturing Practices applicable to the Manufacture of a Licensed Product that are promulgated or otherwise established by any Governmental Authority, including those set forth in the FDA’s Quality System Regulations in 21 C.F.R. Part
820 and any requirements imposed thereunder by the FDA or in any FDA guidance applicable to Q-Med. 
 “Ireland
License Agreement” means the License Agreement, dated as of the date hereof, by and between Q-Med and Cetacea Limited (“Ireland”). 
 “Ireland Supply Agreement” means the Supply Agreement, dated as of the date hereof, by and between Q-Med and Ireland. 

“Labeling” means all labels and other written, printed or graphic material upon or included with any Licensed Product or
any of its containers or wrappers accompanying such Licensed Product, including package leaflets, instructions for use and package inserts and training materials developed by Q-Med. 

“Manufacture” and “Manufacturing” and other forms of such words means the manufacturing, processing,
filling, handling, storage, packaging and quality control testing (including in-process, raw materials, component, manufacturing product release and stability testing) of Licensed Products. 

  
 3 

 “Person” means any individual, firm, corporation, partnership, limited
liability company, trust, joint venture or other entity or organization. 
 “QMS Purchasers” means QMS and any
of its Affiliates and their permitted Sublicensees. 
 “QMS License Agreement” means the License Agreement,
dated as of the date hereof, by and between Q-Med and QMS, as may be amended from time to time in accordance with the terms thereof. 
 “Quality Agreement” means the Quality Agreement, dated as of the date hereof, by and between Q-Med and QMS, allocating responsibilities for certain applicable quality requirements between
the Parties. 
 “Quality System Regulation” or “QSR” shall mean the quality system
requirements applicable to manufacturers of finished medical devices commercially distributed in the United States and its territories and possessions, codified at 21 C.F.R. Part 820. 

“Solesta Product” means the product as defined in the License Agreement and more specifically described on
Schedule B hereto, as Schedule B may be amended from time to time in accordance with Section 2.3 of this Agreement. 
 “Specifications” means the specifications applicable to the Manufacture of a Licensed Product, including quality control testing procedures, that are consistent with the applicable IDE or
Regulatory Approval for such Licensed Product, as may be amended from time to time in accordance with this Agreement, substantially in the same form and using the same degree of specificity as used in describing the Solesta Product and the Deflux
Product on Schedule B. 

  
 4 

 “Subcontractor” means any Person other than Q-Med or its Affiliates that
performs one or more aspects of the Manufacturing of the Licensed Products. 
 “Territory” means the United
States, its territories and possessions. 
 “Units” means with respect to (a) the Solesta Product: a
package containing four pre-filled syringes, each containing 1 ml of gel, plus five needles plus a package insert or instructions for use, or such other definition as the Parties shall designate in the event of modifications to the Solesta Product
hereunder or pursuant to the License Agreement; (b) the Deflux Product: a package containing one pre-filled syringe, containing 1 ml of gel, plus a package insert or instructions for use, or such other definition as the Parties shall designate
in the event of modifications to the Deflux Product hereunder or pursuant to the License Agreement; and (c) other Licensed Products, such other definition as the Parties shall designate. 

1.1 Interpretation. 
 (a) Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” or “including
but not limited to” (or “includes without limitation” 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; 

  
 5 

 (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, Schedules
and Appendices are to Sections, Articles, Schedules, 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 unless the term “Business Days” is used; and 
 (f) Any reference to any supranational, national, federal, state, local, or foreign statute or law shall be deemed to also refer to all rules and regulations promulgated thereunder within any jurisdiction
or jurisdictions subject thereto, unless the context requires otherwise. 
 ARTICLE II. 

SUPPLY OF LICENSED PRODUCT 
 2.1 Licensed Product to be Supplied. QMS shall, and shall cause QMS Purchasers to, purchase from Q-Med, and Q-Med shall Manufacture and supply to the QMS Purchasers, in accordance with the
provisions of this Agreement, the Specifications, GMP and Applicable Laws, all of their requirements for the Licensed Products for Commercialization and for Projects in the Territory, subject to the terms of this Agreement. Neither QMS nor any of
the QMS Purchasers shall directly or indirectly purchase from any Person other than Q-Med (or as authorized under this Agreement) any injectable bulking agent products for use in the Licensed Field. 

  
 6 

 2.2 Forecasts. 

(a) Forecasts and Orders. On or before the last Business Day of each month, QMS shall provide a forecast of the QMS Purchasers’
estimated monthly requirements of each commercially available Licensed Product for the [*] 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. Each Forecast shall include Firm Orders for the quantity of each Licensed Product set forth in Months [*] of such Forecast. Such Firm Order for Month [*] shall be for a quantity of
each article number of each Licensed Product (i.e., separate quantities for each label and each Unit) that is at least [*], but not more than [*] (“Firm Order Maximum Quantities”), of such quantities of such Licensed Product in the
most recent Forecast for such month. The quantities of each label and Unit for each Licensed Product set forth in Months [*] of each Forecast shall be at least [*], but not more than [*], of such quantities of such Licensed Product in the most
recent Forecast for such months. For example, (i) the Forecast submitted on or before [*] shall cover the period from [*] through [*], (ii) the quantities for each label and each Unit of each Licensed Product set forth in such Forecast for
[*] through [*] shall constitute Firm Orders, (iii) such quantities set forth for [*] shall be at least [*], but not more than [*], of such quantities for such month that were set forth in the Forecast submitted on or before [*], and
(iv) such quantities set forth for [*] through [*] shall be at least [*], but not more than [*], of such quantities for such months that were set forth in the Forecast submitted on or before [*]. The quantities of Licensed Product stated in
Firm Orders and conforming to the forecast requirements of this Section 2.2(a) shall be provided by Q-Med in accordance with the terms of this Agreement. 

  
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

7 

 (b) Failure to Purchase. If QMS does not submit Firm Orders that are at least [*] of the
applicable forecasted quantity as described in Section 2.2(a), Q-Med shall deliver to QMS and QMS shall be required to purchase an amount equal to [*] of such applicable forecasted quantity. 

(c) Additional Quantities. QMS shall be entitled to place orders in excess of Firm Orders (“Excess Orders”). Prior to
delivery of an Excess Order, the Parties will discuss Q-Med’s ability to fill the Excess Order, proposed delivery dates and other information relevant to the Excess Order. Notwithstanding the foregoing, Q-Med shall not be obligated to supply
Excess Orders, but shall use Commercially Reasonable Efforts to do so, subject at all times to the limitations imposed by Q-Med’s available production capacity and applicable lead times. 

(d) Delivery of Forecasts. All forecasts to be provided or delivered by QMS to Q-Med pursuant to this Section 2.2 shall be in
writing, which may be electronic. 
 (e) Alternative Ordering and Delivery Procedures. [*] months after the Market Launch of the
Solesta Product in the U.S., and the Market Launch of any new Licensed Product (including a modified version of the Solesta Product), the Parties shall implement more flexible ordering and delivery procedures than described in Section 2.2(a)
for such Licensed Product and/or applicable market. Such procedures shall take into account the specific regulatory, marketing and other issues relevant to each such event, QMS Purchasers’ anticipated requirements for Licensed Product in
the specific market affected, and Q-Med’s seasonal production schedules and reasonable lead times for the delivery of Licensed Products. For 

  
  

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8 

 
example, if QMS commits to the contents of the labeling of a Licensed Product in advance of the [*] month lead time otherwise required by Q-Med, Q-Med shall use commercially reasonable efforts to
prepare such labeling in order to accommodate a scheduled or accelerated Market Launch, provided QMS pays the pre-approved costs of any subsequent change to the labeling, including any costs incurred by Q-Med to scrap or otherwise dispose of any
superseded materials. 
 (f) Other Licensed Products. Upon the addition of a new Licensed Product, the Parties shall negotiate
in good faith such amendments to the terms of this Agreement as may be required to implement the production of or in respect of other terms directly affected by such new Licensed Product, including the applicable Specifications, forecasting, and
ordering lead times and quantities, shelf-life and, as provided in Section 3.3, the applicable Purchase Price. 
 (g) Order
Limitations. QMS shall order the Licensed Products in such minimum quantities as reasonably determined and advised by Q-Med from time to time (the current minimum order size for the Deflux Product is [*] or [*] Units and for the Solesta Product is
[*] Units), and package configurations as the Parties shall establish and set forth in the applicable Specifications. Q-Med shall without undue delay provide notice to QMS of any changes in the applicable minimum order quantities, which shall apply
immediately upon such notice from Q-Med, unless a specific effective date has been provided by Q-Med. 

  
  

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9 

 2.3 Changes to Specifications; Manufacturing and Supplier Changes. 

(a) Changes to the Specifications Required for Compliance. The Parties shall cooperate with each other to amend or supplement the
Specifications to the extent necessary to comply with changes in GMP, Applicable Laws or other requirements of Governmental Authorities. QMS shall be responsible for preparing the appropriate documentation for Q-Med to review and for submitting the
final documentation for such amendment or supplement to the Specifications to the Regulatory Authorities. In this connection the Parties shall cooperate, share information, and otherwise act in good faith to secure and maintain appropriate
Regulatory Approvals. Any FDA or other Regulatory Authority filing fees or other costs associated with any filings or changes made under this subsection shall be borne by QMS. The Parties acknowledge that any changes under this subsection may result
in increases to the Purchase Price of a Licensed Product to reflect changes in Q-Med’s Full Manufacturing Costs as provided in Section 3.2(b) prior to the [*] and [*] anniversary dates mentioned in that subsection or thereafter.

 (b) Manufacturing Changes. Q-Med may make any Manufacturing changes, consistent with GMP, and any such Manufacturing changes
shall not require QMS’ consent, but Q-Med shall keep QMS advised of its efforts to effectuate such changes consistent with QMS’ position as the holder of the PMA. Notwithstanding the foregoing, any Manufacturing changes that are reasonably
likely to shorten the expiry dating of a Licensed Product shall require the prior written consent of QMS, which consent shall not be unreasonably withheld, delayed (beyond twenty (20) calendar days after receipt of written notice from Q-Med) or
conditioned. Q-Med shall be responsible for drafting relevant documentation and shall provide to QMS any 

  
  

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information reasonably necessary for QMS to make appropriate filings with the applicable Regulatory Authority regarding changes under this subsection, if applicable. In any event, Q-Med shall not
implement any Manufacturing changes under this subsection with respect to any Licensed Product prior to receipt of any applicable Regulatory Authority approval required to make such changes. Unless a Manufacturing change was required for compliance
with changes in GMP, Applicable Laws or other requirements of Governmental Authorities (as set out above), (i) any FDA or other Regulatory Authority filing fees or other costs associated with a certain filing or change made under this
subsection shall be borne by Q-Med; and (ii) such Manufacturing change shall not result in any changes to the Purchase Price. 
 (c) Changes to the Specifications or to the Suppliers of Critical Raw Material Requested by Q-Med. If Q-Med wishes to make any changes in the Specifications or to the suppliers of critical raw materials,
not necessary to comply with changes in GMP, Applicable Laws or other requirements of Governmental Authorities, the following shall apply: (i) changes to the Specifications directly relating to the properties of the gel composition of the
Licensed Product shall require the prior written consent of QMS, which consent shall not be unreasonably withheld, delayed (beyond twenty (20) calendar days after receipt of written notice from Q-Med) or conditioned; and (ii) changes to
the suppliers of the raw materials included in the gel, shall not require QMS’ consent, but Q-Med shall keep QMS advised of its efforts to effectuate such changes. For the avoidance of doubt, a change in the gel composition shall be deemed to
include any change in the Critical Parameter/Characteristic of the gel as reflected in Items 1 through 11 under Product Specification on Schedule B or in any similar Specifications applicable to any other Licensed Product. All other changes to the
Specifications other than as described in (i) shall not require the prior written consent of QMS. Q-Med shall be responsible for drafting relevant documentation and shall provide to QMS any information reasonably necessary for

  
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QMS to make appropriate filings with the applicable Regulatory Authority regarding such change, if applicable. Any FDA or other Regulatory Authority filing fees or other costs associated with any
filings or changes made under this subsection shall be borne by Q-Med. Changes to the Specifications or otherwise implemented under this subsection shall not result in any changes to the Purchase Price. Notwithstanding the foregoing, Q-Med shall not
make any such changes prior to receipt of any approval of the applicable Regulatory Authority required to implement such changes. 
 (d) Other Changes Requested by QMS. If QMS wishes to make any changes in the Specifications not necessary to comply with changes in GMP, Applicable Laws or other requirements of Governmental Authorities,
QMS shall notify Q-Med in writing. Any such change will be subject to Q-Med’s consent, which consent shall not be unreasonably withheld, delayed (beyond twenty (20) calendar days after receipt of written notice from QMS) or conditioned.
Any such change shall only be implemented following a technical and cost review which shall be conducted as promptly as is reasonably possible and in good faith by Q-Med and shall be subject to QMS and Q-Med reaching agreement as to revisions, if
any, to the Purchase Price (or one-time costs) necessitated by any such change. If QMS accepts a proposed Purchase Price change, the proposed change in the Specifications shall be implemented, and the Purchase Price change shall become effective
only with respect to those orders of Licensed Products that are Manufactured in accordance with the revised Specifications. QMS shall be responsible to prepare the appropriate documentation for Q-Med to review and to submit the final documentation
to the Regulatory Authorities. In this connection the Parties shall cooperate, share information, and otherwise act in good faith to secure and maintain appropriate Regulatory Approvals. FDA or other Regulatory Authority filing fees associated with
the filings made under this subsection shall be borne by QMS. Notwithstanding any of the foregoing, Q-Med 

  
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may refuse to provide its consent to any changes in the Specifications proposed by QMS if Q-Med reasonably determines that such amendment would have an adverse effect on (i) any of
Q-Med’s other products, or (ii) its Manufacturing activities. 
 (e) Acknowledged Change. (i) QMS was advised by
Q-Med of a proposed change to the Specifications, described in Schedule B, specifically, changing from a glass syringe to a plastic syringe, and QMS hereby consents to that change, subject to FDA approval and such change shall not result in any
increase in the Purchase Price. Q-Med and QMS shall reasonably cooperate on the timing of implementing this proposed change, taking into account existing inventory levels and the need for commercially appropriate expiry dating, and to avoid any
interruption in the Manufacture or delivery to QMS by Q-Med of the Solesta Product; (ii) QMS was also advised by Q-Med of the approval by the FDA of PMA Supplement P000029/S021 (approval for a change in the source of dextranomer material used
to manufacture Deflux injectable gel from DX-10 to DX), which change to the Deflux Product may be implemented at Q-Med’s discretion. 
 2.4 Safety Stocks. Q-Med shall maintain a safety stock of at least [*] months demand of the Licensed Products and QMS shall maintain a safety stock of at least [*] months demand of the Licensed
Products, based on the average quantities of Licensed Products ordered in QMS’ last [*] monthly Firm Orders (the “Q-Med Safety Stock” or the “QMS Safety Stock” as applicable). The Parties intend to increase
each Party’s safety stock to at least [*] months demand once Licensed Product expiration dating makes it feasible to do so. 

  
  

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 2.5 Use of Affiliates, Subcontractors and Alternative Facilities. Q-Med shall have
the right in connection with its obligations hereunder to contract with its Affiliates or one or more Subcontractors for the Manufacture and supply of the Licensed Product to QMS, which may involve the use of Affiliates, Subcontractors or facilities
other than those utilized in the Manufacture of Licensed Products pursuant to the IDEs and Regulatory Approvals (each a “New Affiliate,” “New Subcontractor” or “New Facility”), provided that:
(i) Q-Med shall cause each New Affiliate, New Subcontractor and New Facility to comply fully with the terms and conditions set forth in this Agreement with respect to the Manufacture and supply of Licensed Products, (ii) the use of any New
Affiliate, New Subcontractor or New Facility does not have a material adverse effect on QMS’ ability to Commercialize Licensed Products (provided, however, that any change to a New Affiliate, New Subcontractor or New Facility approved by the
FDA or other applicable Governmental Authority and effected after Q-Med secures any required Regulatory Approval, shall not be deemed to have a material adverse effect on QMS’ ability to Commercialize Licensed Products), and (iii) Q-Med
shall remain fully responsible and liable for the Manufacture and supply of the Licensed Product to QMS and the performance of any New Affiliate, New Subcontractor or New Facility. Q-Med shall bear the costs and expense of any required Regulatory
Approvals due to its contracting with any New Affiliate, New Subcontractor or New Facility for the Manufacture and supply of the Licensed Products. 
 2.6 Quality Agreement. The Quality Agreement contains customary provisions, including provisions addressing product changes, GMP compliance, adverse event reporting, quality methods, records and
inspections, and product recalls and withdrawals. The Parties shall establish reasonable procedures for making changes to the Quality Agreement. The terms and conditions of the Quality Agreement shall be deemed incorporated by reference in this
Agreement, and references to this “Agreement” herein shall be deemed to include the Quality 

  
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Agreement, unless otherwise provided in the Quality Agreement. In the event of a conflict between the terms of this Agreement and the Quality Agreement, the terms of this Agreement shall control.

 2.7 Certain Q-Med Obligations. 
 (a) Conformity. All Licensed Products supplied hereunder shall (i) be in finished form for Commercialization or (ii) be in an appropriate form for Projects, and with respect to each of
sub-clauses (i) and (ii), shall be Manufactured by Q-Med in conformity with the terms and conditions of this Agreement, GMP and the applicable Specifications. 
 (b) Shelf-Life. Unless otherwise agreed in writing by the Parties, (i) if the applicable Regulatory Authority approves the Licensed Product with a [*] month shelf-life, Q-Med will ship the Licensed
Product to QMS with a remaining shelf-life of not less than [*] months, (ii) if the applicable Regulatory Authority approves the Licensed Product with a [*] month shelf-life, Q-Med will ship the Licensed Product to QMS with a remaining
shelf-life of not less than [*] months, and (iii) if the applicable Regulatory Authority approves the Licensed Product with less than a [*] month shelf-life, then the Parties will in good faith discuss how that situation should be managed.

 (c) Acknowledged Obligations. Q-Med shall at its sole cost qualify all suppliers and shall purchase and store all product and
packaging components (including materials to prepare labels, product inserts and other labeling for the Licensed Product), raw materials and other ingredients for the manufacture of the Licensed Product, and be responsible for all raw material
non-conformities. 
  
  

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 2.8 Cooperation and Project Review Meetings. Promptly following the Effective Date,
each Party shall designate those of its employees to be part of a team responsible for managing the manufacturing and supply relationship between the Parties (the “Relationship Team”). The Relationship Team, which shall be a
subcommittee of the Joint Steering Committee, shall meet in person or by telephone or video conference not less frequently than semi-annually to review the current status of activities by the Parties under this Agreement, but its actions shall be
consistent and not in conflict with the activities of the Joint Steering Committee under the License Agreement. 
 2.9
Manufacturing Capacity. Following the submission by QMS of each Forecast, Q-Med will alert QMS to any reasonably foreseeable problems that Q-Med may have fulfilling the forecasted requirements. The Parties shall thereafter in good faith discuss
the Forecasts and Q-Med shall propose reasonable remedial plans to address any potential problems. Such remedial plans may include (i) the addition of another production shift to increase capacity, and (ii) seeking timely approval from all
applicable Regulatory Authorities of Q-Med’s second plant, located adjacent to the Facility, for production of the Licensed Products. 

  
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 ARTICLE III. 
 CONSIDERATION 
 3.1 Pricing. Subject to the terms of this Article,
the purchase price of the Licensed Products shall equal: 
 (a) [*] SEK per Unit for the Solesta Product; 

(b) [*] SEK per Unit for the Deflux Product; and 
 (c) such other prices for different formulations or Units of the Licensed Products as established in accordance with Section 3.3. 

Each price, as adjusted or established as provided in this Article, shall be referred to as the “Purchase Price”.

 3.2 Purchase Price Adjustments. 
 (a) The Purchase Prices set forth in Section 3.1(a) and (b) shall be fixed for a period of [*] years for the Deflux Product and [*] years for the Solesta Product from the Effective Date, except
as provided in this Section 3.2. As of the [*] and [*] anniversary of the Effective Date respectively, and each anniversary thereafter, all such prices (including those established after the Effective Date under Section 3.3), shall be
increased (but never decreased) by the lesser of (i) [*], or (ii) [*], except that the first increase to be implemented on the [*] and [*] anniversary of the Effective Date respectively shall take into account changes in the [*] from the
Effective Date, but in such case the [*] shall not exceed [*] in the aggregate for the entire applicable [*] or [*]-year period. Notwithstanding the foregoing, in the event of the appointment of a Third Party Manufacturer under Section 6.4, the
Purchase Price then in effect shall be adjusted, if necessary, to ensure that Q-Med receives the same profit margin it was receiving 

  
  

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prior to the appointment of the Third Party Manufacturer without considering any costs incurred by Q-Med to establish and validate the Third Party Manufacturer. If it appears likely that any
Purchase Price will increase by [*] or more as a result of the appointment of a Third Party Manufacturer, then Q-Med will promptly notify QMS and QMS may participate in the price negotiations with the Third Party Manufacturer. 

(b) The Purchase Price for each Licensed Product shall also be adjusted from time-to-time, including during the period from the Effective
Date to the [*] and [*] anniversary respectively thereof, to reflect increases in Q-Med’s Full Manufacturing Costs of the Licensed Product as a result of required changes in GMP, Applicable Laws or other requirements of Governmental
Authorities. If Q-Med desires to implement any price adjustment under this Section, it shall provide QMS at least [*] days written notice, accompanied by written documentation justifying the adjustment. Any such adjustment will be implemented with
regard to any Firm Orders or Excess Orders placed after such [*] day period. 
 (c) At the request of QMS, Q-Med shall allow an
independent auditor to verify any adjustment to the Purchase Prices pursuant to this Section 3.2 or any determination of or adjustment to the Purchase Prices under Section 3.3. QMS shall pay the costs of such auditor. For the purpose of
clarity, QMS acknowledges that it will not have access to the information supplied to the independent auditor by Q-Med under this Section. 
 (d) Q-Med shall keep and cause its Affiliates to keep, and shall use Commercially Reasonable Efforts to cause Third Parties to keep, complete and accurate records in sufficient detail to enable a
calculation of Full Manufacturing Costs or the applicable Purchase Price adjustment. 

  
  

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 3.3 Purchase Price for other Licensed Products. The initial Purchase Prices
for Licensed Products (other than the Deflux and Solesta Products as of the Effective Date as described in Section 3.1(a) and (b)), shall equal such amount as the Parties shall negotiate in good faith following finalization of the
Specifications for such Licensed Product and QMS’ submission of its first Forecast for such Licensed Product. If the Parties are unable to agree on the Purchase Price within [*] days after QMS submits its first Forecast, the Purchase Price for
such Licensed Product shall be equal to Q-Med’s Full Manufacturing Costs as determined by using the same cost accounting method used by Q-Med, plus the same overhead and profit margin (in SEK), that was included in determining the Purchase
Prices in Section 3.1(a) and (b). The Purchase Prices, as so determined for Licensed Products other than the Solesta Product and the Deflux Product, shall be subject to adjustment thereafter under Section 3.2. 

3.4 Purchase Price for Clinical Testing Products. The purchase price for any Clinical Testing Products, not corresponding
to any of Q-Med’s then commercially available products, shall be agreed between the Parties on a case by case basis. 

3.5 Payment Obligations. 
 (a) Invoices for the Purchase Price shall be issued upon shipment and shall be payable in SEK within [*] days from the date of invoice. 

  
  

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 (b) All payments shall be made by wire transfer to an account, which account shall be
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 QMS on or before the date specified in this Section 3.5 shall bear
interest from the date such payment is due (without considering any cure period) 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 [*]. Notwithstanding the foregoing, if at any time QMS has failed to pay an invoice or part thereof, in full when due (a “Delinquent
Payment”) and the aggregate amount of such Delinquent Payments exceeds [*] 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) to but excluding the date of payment. 

ARTICLE IV. 

DELIVERY AND WARRANTY 
 4.1 Purchases, Shipments and Delivery. 
 (a) Delivery Terms. Q-Med shall
deliver the Licensed Products FCA (INCOTERMS 2000) Q-Med’s Facility, or New Facility, as the case may be, and Q-Med shall, on behalf of QMS and at QMS’ expense, make such arrangements for shipping and export as instructed by QMS and shall
provide all export and import documentation within Q-Med’s 

  
  

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control to provide, with respect to the Licensed Products. QMS may designate one (1) destination for shipments of Licensed Products. Q-Med shall not be required to ship the Licensed Products
to more than one (1) destination. If a shipment of Licensed Product ordered by QMS under this Agreement has not been available for pick-up at the shipping point within [*] Business Days after the scheduled delivery date (any date of delivery
that is more than [*] Business Days after the scheduled delivery date is hereinafter referred to as a “Late Delivery Date”) stated on the corresponding accepted Firm Order (a “Late Shipment”), or if the shipment
received by QMS contains a variance of greater than plus or minus [*] of the quantity specified in the corresponding Firm Order or Excess Order (a “Variant Shipment”), QMS shall promptly notify Q-Med upon such discovery. Q-Med shall
use its best efforts with respect to a Firm Order (and commercially reasonable efforts with respect to an Excess Order) to deliver the quantity of Licensed Product it had failed to ship in the case of a Late Shipment or a Variant Shipment that is
short the quantity ordered, as soon as possible after notification of such shortage, by air transportation on the next available commercial flight, at Q-Med’s expense in respect of any difference in cost for such means of transportation
relative to QMS’ regular delivery costs if the cause for such Variant Shipment was within Q-Med’s control and if such means of transportation is requested by QMS. In the case of a Variant Shipment that contains more than the quantity
ordered, QMS may elect to deduct such excess deliveries from future Firm Orders. Notwithstanding the foregoing, QMS shall be entitled to return to Q-Med any Licensed Products delivered in excess of that ordered in the corresponding Firm Order or
Excess Order if in the preceding [*] month period it has accepted, under the terms of this Section, delivery of Licensed Products in excess of [*] of one or more Firm Orders or Excess Orders during that period. 

  
  

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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 QMS Firm Order, Excess Order, Q-Med order acknowledgement or any other document, or any other terms and conditions included in any such other document, except insofar as any such mutually accepted order
or other document establishes: (i) the quantity of Licensed Products ordered and sold; (ii) the delivery date of Licensed Products; or (iii) the destination of shipment of Licensed Products. Any additional, inconsistent or different
terms and conditions contained in such other documents are hereby expressly rejected. 
 (c) Shipping Documentation. Q-Med shall
include a packing list in each shipment of Licensed Products which shall provide the following information: (i) the applicable Firm Order, (ii) quantity, and (iii) Q-Med lot number, a copy of the applicable Certificate of Analysis
(see Schedule C) and all export and import documentation within Q-Med’s control to provide. 
 4.2 Product
Acceptance. 
 (a) Product Acceptance. QMS shall be entitled to reject all or any portion of a shipment of Licensed
Products within [*] days of delivery of such shipment of Licensed Products to QMS, based solely on obvious physical, packaging or Labeling damage or defect that would be evident upon visual inspection of the packaged Licensed Products 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

  
  

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of QMS or any of its Affiliates or any carrier after delivery by Q-Med in accordance with this Agreement (a “Visual Non-Conformity”). If QMS does not provide written notice of
any such rejection within the period set forth above together with a reasonably detailed statement to support any such rejection, then QMS shall be deemed to have accepted the entire shipment and waived its right to reject the shipment based upon a
Visual Non-Conformity. QMS 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 QMS as promptly as reasonably
possible, but in any event within [*] Business Days after receipt of such written notice, whether it agrees with QMS’ assertions with respect thereto. If Q-Med agrees with such assertions, all such rejected Licensed Products shall be returned
to Q-Med together with the notice of rejection, a copy of the delivery receipt and the reasonably detailed statement of QMS’ reasons for rejection and Q-Med shall replace such Licensed Products and shall reimburse QMS for the cost of shipping
(including insurance). If Q-Med does not agree with QMS’ assertions and QMS accepts Q-Med’s determination, then QMS shall be responsible for the price of the Licensed Product (including the shipping cost and insurance), and if QMS 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 QMS’ finding of a Visual Non-Conformity, Q-Med
shall promptly supply QMS 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 Commercial Reasonable Efforts, shall replace any shipment or portion of a shipment under dispute, and QMS shall pay the applicable Purchase Price, subject to a
credit if such dispute is resolved in QMS’ favor. 

  
  

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 (b) Latent Defects. For purposes of this subsection, a latent defect is a defect not
reasonably susceptible to discovery by visual inspection, including a defect requiring laboratory analysis to identify (a “Latent Defect”), other than non-conformities covered under 4.1(d)(ii) or 4.2(a) above. If it comes to
QMS’ attention that any Licensed Products previously accepted may have a Latent Defect, QMS shall provide prompt notice thereof to Q-Med (and in no event later than [*] Business Days thereafter) together with a reasonably detailed statement
describing the alleged Latent Defect. If the Latent Defect occurred or is attributable to an event which occurred prior to delivery to QMS at Q-Med’s Facility or New Facility, as the case may be, of the applicable Licensed Products to QMS, then
all subject Licensed Products remaining on hand shall be returned to Q-Med and Q-Med shall replace such Licensed Products in accordance with Section 4.2(a) and shall reimburse QMS for the cost of shipping and insurance. If the cause of the
Latent Defect is attributable to any other event, then QMS shall be responsible for the price of the subject Licensed Products (if not already paid). 
 (c) Shelf-Life of Replacement Products. All Licensed Products provided in replacement shipments pursuant to Sections 4.2(a) or (b) above shall have a minimum remaining shelf-life consistent with the
provisions of Section 2.7(b). 

  
  

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 4.3 Warranties. 

(a) Product Warranties. Q-Med warrants to QMS: 
 (i) that Q-Med shall convey good title to the Licensed Products, upon delivery of the Licensed Products to QMS in accordance with this Agreement and such Licensed Products shall be free and clear of any
security interest, claim, lien or encumbrance; 
 (ii) that the Licensed Products shall comply and shall have been Manufactured
by or on behalf of Q-Med in conformity with GMP and the Specifications; 
 (iii) that the Licensed Products shall not be
adulterated or misbranded (QMS being responsible, however, for any Labeling or other materials or instructions provided by QMS in writing to Q-Med) within the meaning of the FDCA or other Laws as of the time that the Licensed Product is transferred
to the carrier at Q-Med’s shipping point; and 
 (iv) that the shelf-life of Licensed Products shipped to QMS is
consistent with the provisions of Section 2.7(b). 
 (b) Exclusions. Q-Med’s warranties shall not apply to any
Licensed Products to the extent such Licensed Products: (1) have been subjected to misuse, negligence or accident after delivery to QMS or its designee; (2) have been stored or used in a manner contrary to Labeling after delivery to QMS or
its designee; (3) were used after their respective expiration dates; or (4) have been modified or combined in any way with other products in a manner not permitted by the labeling for such Licensed Products. 

(c) Exclusive Remedies. Indemnification under Section 4.4 and correction of nonconformities in the manner and for the period of time
provided in this Agreement shall be QMS’ 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 Products. 

  
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 4.4 Indemnification. 

(a) Except to the extent provided in (c) below, and subject to Section 9.1 below, Q-Med shall indemnify, defend and hold
harmless QMS and its Affiliates and Sublicensees, and its and their respective officers, directors, shareholders successors, assigns, agents, employees and insurers in such capacity (collectively the “QMS Indemnified Parties”) from
and against any and all liability, claims, damages, losses or reasonable expenses (including attorneys’ fees, expert fees and costs of investigation incurred by QMS), arising out of or relating to Actions against QMS Indemnified Parties by
Third Parties (collectively “QMS Losses”) in respect of, without duplication (including any remedy or indemnification under any other agreement between the Parties or their Affiliates): 

(i) the breach by Q-Med of any of its representations, warranties, covenants and other agreements made hereunder; 

(ii) personal injury or death sustained by any patient through the use of a Licensed Product, but only if such use was fully in
conformity with Labeling, and provided further that such injury is proximately caused by: (A) a flaw, defect or imperfection in the Manufacturing or design of such Licensed Product; or (B) a Licensed Product containing an inherently
dangerous characteristic not then required to be disclosed in Labeling or required to be disclosed but was not so disclosed (clauses (A) and (B) hereof being referred to collectively as “Q-Med’s Responsibility”);
provided, however, no claim for indemnity under this subsection (ii) may be brought by QMS unless and until the aggregate amount of QMS Losses sustained in 

  
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respect of matters within Q-Med’s Responsibility, including any amounts paid by QMS under Section 4.4(b)(ii), exceed $[*] (the “Threshold”) whereupon Q-Med’s
liability shall be for amounts in excess of the Threshold; and 
 (iii) any property damage, or non-patient personal injury or
death sustained through the use of a Licensed Product solely to the extent proximately caused by the negligence of Q-Med in Manufacturing such Licensed Product. 
 (b) Except to the extent provided in (c) below, and subject to Section 9.1 below, QMS shall indemnify, defend and hold harmless Q-Med and its Affiliates, and its and their respective officers,
directors, shareholders successors, assigns, agents, employees and insurers in such capacity (collectively the “Q-Med Indemnified Parties”) from and against any and all liability, claims, damages, losses or reasonable expenses
(including attorneys’ fees, expert fees and costs of investigation) incurred by Q-Med, arising out of or relating to Actions against Q-Med Indemnified Parties by Third Parties (collectively “Q-Med Losses”), in respect of,
without duplication (including any remedy or indemnification under any other Agreement between the Parties or their Affiliates): 
 (i) the breach by QMS of any of its representations, warranties, covenants and other agreements made hereunder; 
 (ii) personal injury or death sustained by any patient through the use of a Licensed Product proximately caused by matters within Q-Med’s Responsibility, until the aggregate amount of QMS’
Losses incurred by QMS under Section 4.4(a)(ii) and this Section 4.4(b)(ii) 

  
  

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27 

 
exceed the Threshold, but nothing in this subsection (ii) shall be deemed to obligate QMS to reimburse Q-Med for any expenses incurred by Q-Med in connection with any such Actions by Third
Parties against Q-Med Indemnified Parties; 
 (iii) personal injury sustained by any patient through the use of a Licensed
Product proximately caused by acts or omissions of QMS or its Sublicensees not in accordance with Labeling; and 
 (iv) any
property damage, or non-patient personal injury or death sustained through the use of a Licensed Product solely to the extent proximately caused by the negligence of QMS, or by other acts or omissions of QMS or its Sublicensees not in accordance
with Labeling. 
 (c) Notwithstanding anything to the contrary set forth in this Agreement, neither Party shall be obligated to
indemnify the other Party as provided in this Section: (i) to the extent any indemnifiable Losses thereunder are caused by such other Party’s, or its Affiliates’, sublicensees’ or assigns’ negligence, intentional misconduct
or breach of such other Party’s obligations, warranties or representations set forth herein; (ii) any claim by a sublicensee, distributor, wholesaler or other person in the business of purchasing products such as a Licensed Product for
resale and not for use; or (iii) any Third Party Action seeking, directly or indirectly, to recover consequential, incidental, punitive or liquidated damages (collectively “Special Damages”) pursuant to contract with a Party
that fails to exclude the right of such Third Party to recover such Special Damages, provided, however, to the extent such contract contains such an exclusionary provision but such provision is avoided or annulled in the Third Party Action under
applicable principles of law or equity, the indemnifying Party’s liability shall equal fifty percent (50%) of the Special Damages awarded therein. The foregoing limitations in (ii) and (iii) above

  
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shall not apply to the extent such Third Party Action seeks recovery of damages for personal injury or death or property damage sustained by an end user of a Licensed Product that were the
proximate result of matters within Q-Med’s Responsibility, or due to the negligence of QMS, or due to other acts or omissions of QMS not in accordance with Labeling. Nothing in this Article IV shall limit any other rights or remedies either
Party may have against the other under this Agreement in respect of such other Party’s negligence, intentional misconduct or breach of any provision of this Agreement unless such a claim or remedy is otherwise expressly barred under the terms
of this Agreement. 
 (d) Procedure. The Party seeking indemnification shall provide the indemnifying Party with written notice
of any claim or action within [*] business days of its receipt thereof, and shall afford the indemnifying Party the right to control the defense and settlement of such claim or action. A failure by the Party seeking indemnification to give notice
and to tender the defense in a timely manner pursuant to this Section 4.4(d) shall not limit the obligation of the indemnifying Party under this Article IV, except to the extent such indemnifying Party is materially prejudiced thereby. The
Party seeking indemnification shall provide reasonable assistance to the indemnifying Party in the defense of such claim or action at its own expense. If the defendants in any such action include both Parties, and the indemnified Party concludes
that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the indemnifying Party, the indemnified Party shall have the right to select separate counsel to participate in the
defense of such action on its behalf, and the indemnified Party shall bear the cost and expense of such separate defense, 

  
  

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29 

 
unless and to the extent the Parties otherwise agree or it is determined through dispute resolution hereunder that such costs and expense are or were required to be indemnified by the
indemnifying Party and are or were required to be incurred separately due to such different, additional, or inconsistent defenses. Should the indemnifying Party determine not to defend such claim or action, the indemnified Party shall have the right
to maintain the defense of such claim or action and the indemnifying Party shall provide reasonable assistance to it in the defense of such claim or action and shall bear the reasonable cost and expense of such defense (including reasonable
attorneys’ fees). Neither Party shall settle any such claim or action in a way that prejudices or adversely impacts the other Party without the prior approval of such other Party (which approval shall not be unreasonably conditioned, withheld
or delayed). Following issuance of a notice of demand for indemnity by the indemnified Party, to the extent requested by the indemnifying Party, the indemnified Party must, as soon as reasonably practicable, discontinue any conduct that forms the
basis for the claim or claims in any such action or threatened action. 
 (e) The Parties understand and acknowledge that the
provisions of this Section 4.4 are identical to provisions included in the Ireland Supply Agreement, that it is not intended that there be two (2) separate Thresholds and consequently, amounts otherwise included in the Threshold under
either agreement shall be aggregated to determine if the Threshold of $[*] has been exceeded. 

  
  

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30 

 4.5 Compliance with Laws. 

(a) General. Q-Med and QMS shall each comply in all material respects with all applicable Laws that pertain to the activities for which
Q-Med and QMS are each responsible under this Agreement and, except as otherwise contemplated by this Agreement, each shall bear its own costs and expenses related to such compliance. The termination or expiration of this Agreement shall not relieve
either Party of its responsibility to comply in all material respects with any regulatory requirements associated with Licensed Products, which requirement survives such termination or expiration. 

(b) Manufacture of Licensed Products. Q-Med and QMS shall each operate in substantial compliance with QSR requirements and corresponding
foreign requirements applicable to their respective activities with respect to Licensed Products. Each Party shall bear its own costs and expenses related to such compliance. Q-Med shall promptly inform QMS of any material issues raised by the FDA,
a Governmental Authority or a Notified Body, in each case in connection with Manufacturing compliance for Licensed Products, and shall promptly provide QMS with copies of any correspondence (including e-mails) related to such material issues.

 (c) Supply of Licensed Products. Q-Med shall maintain appropriate establishment registration (including payment of
establishment fees) with the FDA and comparable Governmental Authorities when Manufacturing Licensed Products supplied under this Agreement. Q-Med shall supply Licensed Products for Projects that conform to the conditions of any applicable IDE,
including the quality controls described therein (or appropriate quality controls for an IDE Application deemed approved pursuant to the requirements set forth in 21 C.F.R. Part 812). QMS will similarly maintain all required registrations with the
FDA and comparable Governmental Authorities when performing under this Agreement. 

  
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 4.6 Product Complaint; Recalls. 

(a) Product Complaints. The Parties shall cooperate in investigating and resolving complaints concerning the Licensed Products, 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 adverse event reporting obligations, which shall include appropriate provisions for recording worldwide customer complaints relating to Licensed Products and prompt notice
to the other Party of significant and/or potentially reportable adverse events. The Parties shall cooperate fully in dealing with product complaints concerning the Licensed Products and shall take such action to promptly resolve such complaints as
may be reasonably requested by the other Party. QMS shall provide appropriate medical advisory support to patients and physicians concerning the use of the Licensed Products and responding to product complaints and adverse events. Each Party shall
be entitled to review the other Party’s product complaint records related to the Licensed Products, not more than [*] during any [*] month period, in order to verify information provided by a Party to the other Party hereunder. 

  
  

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 (b) Recalls. If either Party determines that an event, incident or circumstance has occurred
which may reasonably result in the need for a recall or market withdrawal (collectively, “Recalls”), that Party shall promptly (and in no event more than two (2) Business Days after discovery) advise
the other thereof by telephone or facsimile, after which the Parties shall promptly discuss and work together to effect an appropriate course of action. The Parties agree to cooperate and acting in good faith shall consider and implement all
reasonable alternatives before initiating any Recall efforts. The Parties agree that patient safety is the primary consideration. Notification to the applicable Regulatory Authority or Government Authority and conducting a Recall shall be the
responsibility of QMS, but in that connection QMS shall reasonably consult with Q-Med. Q-Med shall (i) cooperate fully with QMS in the event of a Recall of any affected Licensed Products in Q-Med’s possession, and (ii) provide such
assistance in connection therewith as QMS may reasonably request. The Parties shall allocate between them the expenses of any Recall in the same manner as provided in Section 4.2(a) based upon which Party is responsible for the Recall. Such
expenses of Recall shall include the expenses of notification and destruction or return of the recalled Licensed Products, and distribution of replacement Licensed Products to Third Parties, if applicable. Any Recall required by any applicable
Governmental Authority shall be handled as described in this Section unless the Governmental Authority directs otherwise. For the avoidance of doubt, in the absence of any directive from a Governmental Authority to recall a Licensed Product, QMS
shall make the ultimate decision to effect and handle a Recall, subject, however, to the terms of this Section and provided such decision is reasonable under the circumstances. 
 ARTICLE V. 
 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 obligations hereunder. 

  
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 (b) Its execution, delivery and performance of this Agreement have been duly authorized by
all requisite corporate action. 
 (c) This Agreement has been duly executed and delivered by such Party and, assuming the due
authorization, execution and delivery hereof by the other Party, constitutes a legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except to the extent that such enforcement may be subject
to applicable bankruptcy, insolvency, reorganization, moratorium or other Laws of general application relating to or affecting enforcement of creditors’ rights and Laws concerning equitable remedies. 

(d) The execution, delivery and performance by such Party of this Agreement and the consummation by such Party of the transactions
contemplated hereby do not and will not, with or without the giving of notice or the passage of time or both, violate, conflict with or result in the breach or termination of or constitute a default under (i) any provision of its corporate
charter or by-laws (or similar organizational documents) of such Party, (ii) the provisions of any Law or governmental order applicable to such Party or its assets, properties or businesses, (iii) any note, bond, mortgage, indenture,
contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which such Party is a party or by which any of such Party, the Licensed Products or such Party’s intellectual property rights necessary for
the performance of this Agreement are bound or affected, or (iv) any judgment, decree, order or award of any Governmental Authority applicable to such Party or its properties or assets. 

  
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 (e) Except as otherwise described in this Agreement or the License Agreement, no permit,
approval, authorization or consent of any person is required in connection with the execution, delivery and performance by either Party of this Agreement or the consummation of the transactions contemplated hereby. 

5.2 Additional Q-Med Representations and Covenants. 
 (a) Q-Med shall promptly disclose to QMS any and all form 483’s or warning letters (including foreign equivalents) it receives with respect to the Manufacture of the Licensed Products, including
those with respect to the Facility (or the New Facility) to the extent relevant to the Manufacture of the Licensed Products and any import alerts about which Q-Med receives notice for Licensed Products or any other products manufactured in the
Facility. 
 (b) Neither Q-Med nor any of its Affiliates or the employees thereof, or any Subcontractors performing services
for, or raw material or component suppliers providing such materials or components to, Q-Med hereunder is, to Q-Med’s knowledge, (i) under investigation by the FDA for debarment action, (2) presently debarred under the regulations of
the FDA, or (3) presently debarred pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. ‘301 et seq.). Q-Med shall promptly (but in all events within thirty (30) Business Days) of discovery) notify QMS in writing to the
extent that this representation is no longer true. For the purposes of this subsection, “knowledge” means the actual knowledge of the directors and officers of Q-Med. 

5.3 Additional QMS Representations and Covenants. 
 (a) QMS shall promptly disclose to Q-Med any and all form 483’s or warning letters (including foreign equivalents) it receives with respect to the Licensed Products. 

  
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 (b) Neither QMS nor any of its Affiliates or the employees thereof, or any of QMS’
independent sales force is, to QMS’ knowledge, (i) under investigation by the FDA for debarment action, (2) presently debarred under the regulations of the FDA, or (3) presently debarred pursuant to the Generic Drug Enforcement
Act of 1992 (21 U.S.C. ‘301 et seq.). QMS shall promptly (but in all events within thirty (30) Business Days of discovery) notify Q-Med in writing to the extent that this representation is no longer true. 

(c) QMS shall (i) cause all Licensed Products delivered to it to be stored and transported properly and in accordance with the
applicable labeling requirements and GMP, (ii) and not ship any expired Licensed Products to customers. 
 5.4 NO OTHER
REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 4.3, THIS ARTICLE 5 OR IN ARTICLE 8 OF THE LICENSE AGREEMENT, Q-MED MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER AT LAW OR IN EQUITY, RELATED TO THE
LICENSED PRODUCTS, INCLUDING ANY REPRESENTATION OR WARRANTY AS TO VALUE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR FOR ORDINARY PURPOSES, OR ANY OTHER MATTER. 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. 

  
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 ARTICLE VI. 
 TERM AND TERMINATION 
 6.1 Term. Unless earlier terminated in
accordance with Section 6.2, this Agreement shall commence on the Effective Date and shall continue until expiration or termination of the License Agreement, unless earlier terminated in accordance with the terms and conditions of this
Agreement. 
 6.2 Early Termination for Default. 
 (a) Subject to the provisions of Section 6.4, if either Party (“Breaching Party”) commits a material breach of a material obligation under this Agreement, the other Party
(“Terminating Party”) may terminate this Agreement. The Terminating Party shall provide written notice to the Breaching Party, which notice shall identify the material breach with specificity, 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 ([*] days in respect of any payment default) after written notice is provided to cure such breach. If such breach is
not cured within [*] days (or [*] days if applicable), or if the breach is not capable of cure, the Terminating Party may terminate this Agreement immediately upon written notice to the Breaching Party. 

(b) Either Party may terminate this Agreement at any time during the Term by giving written notice to the other Party if the other Party
files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party

  
  

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or of its assets, or if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed with [*] days after the filing
thereof, or if the other Party proposes or is a party to any dissolution or liquidation, or if the other Party makes an assignment for the benefit of creditors. 
 (c) Either Party may terminate this Agreement simultaneously with any termination of the QMS License Agreement, the Ireland License Agreement or the Ireland Supply Agreement. 

6.3 Effect of Termination or Expiration. 
 (a) Upon expiration of this Agreement (for any reason other than pursuant to the provisions of Section 6.2), Q-Med will promptly furnish to QMS a complete inventory of all work-in-progress for the
Manufacture of the Licensed Products and an inventory of all finished Licensed Products. Unless otherwise agreed to between the Parties, all stock on hand as of such termination will be dealt with promptly as follows: 

(i) Licensed Products Manufactured pursuant to Firm Orders accepted by Q-Med will be delivered by Q-Med to QMS, whereupon QMS will pay
Q-Med therefor in accordance with the terms of the Supply Agreement; 
 (ii) For a period of [*] months following termination,
QMS shall be entitled to sell in the ordinary course of business any Licensed Products comprising its inventory (and all Licensed Products then in transit or subject to Firm Orders); provided that, absent evidence of justifying market conditions
that QMS shall have the burden to establish, QMS shall 

  
  

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38 

 
not sell Licensed Products at a per Unit price less than the average Unit price obtaining in the [*] months preceding such termination (all such sales shall be subject to all applicable terms of
this Agreement and the License Agreement, including QMS’ obligation to report and pay applicable Royalties with respect to those sales). 
 (b) Upon termination of this Agreement pursuant to the provisions of Section 6.2, the following provisions shall apply: 
 (i) If Q-Med is the Terminating Party, it may either (1) buy back all of QMS’ inventory of Licensed Products at the Purchase Price of such Licensed Product, provided it elects to do so within
[*] days of termination in which event QMS shall thereafter cease any sales of the Licensed Products, or (2) permit QMS for a period of [*] months after termination to sell in the ordinary course of business any Licensed Products comprising
QMS’ inventory of all Licensed Products (and all Licensed Products then in transit or subject to Firm Orders); provided that, absent evidence of justifying market conditions that QMS shall have the burden to establish, QMS shall not sell
Licensed Products at a per Unit price less than the average Unit price obtaining in the [*] months preceding such termination (all such sales shall be subject to all applicable terms of this Agreement and the License Agreement, including QMS’
obligation to report and pay applicable Royalties with respect to those sales). 
 (ii) If QMS is the Terminating Party, it may
either (1) sell all of its inventory of Licensed Products to Q-Med at the Purchase Price of such Licensed Products, or (2) accept delivery by Q-Med of all Firm Orders and thereafter for a period of [*] months after

  
  

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39 

 
termination sell in the ordinary course of business any Licensed Products comprising its inventory (and all Licensed Products then in transit or subject to Firm Orders); provided that, absent
evidence of justifying market conditions that QMS shall have the burden to establish, QMS shall not sell Licensed Products at a per Unit price less than the average Unit price obtaining in the [*] months preceding such termination (all such sales
shall be subject to all applicable terms of this Agreement and the License Agreement, including QMS’ obligation to report and pay applicable Royalties with respect to those sales). 

(c) Upon expiration or termination of this Agreement pursuant to Section 6.2, each of QMS 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 QMS 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 one archival copy may
be retained by each Party’s outside counsel or in-house counsel. 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 6.3(c) 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

  
  

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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. Further, in the event that QMS is selling off inventory pursuant to Section 6.3(a) over a [*] month
period, it may be necessary for QMS to maintain certain documentation to effectuate a permitted sell off hereunder, and so, therefore, the archival copy referenced above shall function in such capacity to facilitate the permitted sell off and QMS
will continue to be bound by its obligations of confidentiality under Article 8 herein. 
 (d) Upon termination or expiration
this Agreement, all obligations of the Parties hereunder shall terminate, except for Section 3.5, Article IV, Section 5.4, Section 6.3, Section 7.2, Section 8.1 and Article IX; provided, that termination will not relieve a
defaulting or breaching Party from any liability to the other Party, including the obligation to pay invoiced amounts when due. 

(e) The Parties agree that in connection with any action by the Terminating Party against the Breaching Party, the Terminating Party
shall not be entitled to claim or recover lost profits or similar damages unless the Breaching Party is determined to have willfully and intentionally committed a material breach of a material obligation under this Agreement. Subject to the
provisions of Section 6.4, the Parties further agree that in any action alleging that Q-Med is the Breaching Party, QMS shall not seek nor shall any court have the power or authority by agreement of the Parties to appoint, or grant a license
in, to, or under any Q-Med IP (as such term is defined in the License Agreement) to, a Third Party as an alternative or supplementary manufacturer of any of the Licensed Products. 

  
  

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 6.4 Failure to Supply. 

(a) Notwithstanding any of the foregoing, QMS’ sole remedy in the event of a failure by Q-Med to supply Licensed Products in
accordance with the terms of this Agreement shall be governed by this Section 6.4. 
 (b) A failure by Q-Med to supply
Licensed Products shall be deemed to occur if Q-Med fails to supply at least [*] of the aggregate quantities of Licensed Products covered by Firm Orders under this Agreement and the Ireland Supply Agreement for a period of any [*] consecutive months
and fails to deliver the shortfall during the [*] month period following such [*] month period. In determining the percentage of a Firm Order delivered in a specific delivery period, and whether a shortfall below [*] has occurred, the aggregate
quantity of Excess Orders shipped during the prior [*] month period under this Agreement and the Ireland Supply Agreement shall be allocated on a pro-rata basis to the quantities shipped under Firm Orders under this Agreement and the Ireland Supply
Agreement covering the same period. In the event a failure to supply occurs hereunder, QMS may request that Q-Med appoint at Q-Med’s expense an additional Third Party Manufacturer of the Licensed Products, which may also be QMS. If so
requested, Q-Med shall use Commercially Reasonable Efforts to promptly enter into an arrangement with a Third Party to Manufacture the Licensed Products. Upon conclusion of a manufacturing agreement with such Third Party Manufacturer, Q-Med
shall promptly provide 

  
  

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42 

 
such relevant and necessary Manufacturing information and other assistance as may be required to enable the Third Party Manufacturer to validate a manufacturing facility and commence the
Manufacture of Licensed Products in accordance with the applicable Specifications and GMP, for sale to QMS under this Agreement and for sale to Ireland under the Ireland Supply Agreement. Following the appointment of an additional Manufacturer, if
[*] of Firm Orders are thereafter delivered to QMS and under the Ireland Supply Agreement for a consecutive [*] month period, then Q-Med may at any time thereafter, decide, in its sole discretion, to continue using the Third Party Manufacturer or
terminate such manufacturing arrangement. Any damage to the Facility (or any New Facility) that causes or contributes to a failure by Q-Med to supply Licensed Products under the terms of this Section 6.4(b), and which would otherwise be
considered an event of Force Majeure under Section 9.2 shall, notwithstanding the provisions of Section 9.2, trigger the rights and obligations of the Parties under this Section 6.4(b), but in the latter event, the Parties shall
equally share all costs attributable to the appointment and validation of any such additional Third Party Manufacturer. 
 (c)
The Parties understand and acknowledge that the rights granted in this Section 6.4 are duplicative of rights that have been granted to Ireland under the Ireland Supply Agreement and that such rights may only be exercised by either QMS or
Ireland (but not both) in the event of a failure to supply as described under Section 6.4(a). 
 6.5 Manufacturing
License Option. Upon the occurrence of a Major Financial Deficit (as defined below), QMS shall have the right to require Q-Med to grant QMS the non-exclusive right to Manufacture the Licensed Product, with a right to sublicense, on the terms set

  
  

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forth in Schedule D (“Manufacturing License”). A “Major Financial Deficit” means the point in time when Q-Med’s equity capital, calculated in accordance
with Chapter 25, Section 14 of the Swedish Companies Act (2005:551), is less than seventy percent (70%) of Q-Med’s registered share capital (currently SEK 24,845,500), as modified from time to time. 

Upon occurrence of a Major Financial Deficit, Q-Med shall promptly provide written notice to QMS and inform QMS of the situation and
explain the circumstances causing the Major Financial Deficit. Before QMS may invoke its Manufacturing License Option, the Parties shall promptly and in good faith discuss how Q-Med intends to cure the Major Financial Deficit and evaluate any
available alternative options for securing the supply of Licensed Product to QMS. 
 If the Parties fail to agree on an
alternative measure within [*] business days following Q-Med’s notice that a Major Financial Deficit has occurred, QMS may invoke its option hereunder to secure a Manufacturing License, in which event Q-Med shall promptly initiate the procedure
to provide to QMS such relevant and necessary Manufacturing information and other assistance as may be required to enable QMS to validate a Manufacturing facility in order to commence Manufacture of Licensed Products in accordance with the
applicable Specifications and GMP, for sale to QMS under this Agreement and for sale to Ireland under the Ireland Supply Agreement. 

  
  

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 Following the occurrence of a Major Financial Deficit and the subsequent grant to QMS of a
Manufacturing License hereunder, if it is concluded that no Major Financial Deficit has in fact occurred under the applicable provisions of the Swedish Companies Act, then Q-Med may decide, at any time thereafter, in its sole discretion, to revoke
the Manufacturing License granted to QMS. For the sake of clarity, in the event of any such revocation, QMS’ right to secure a Manufacturing License under this Section shall remain valid under this Agreement for any subsequent Major Financial
Deficit occurring thereafter. If Q-Med should revoke such a license, QMS has the right to be compensated for all reasonable costs that have occurred in connection with any technology transfer, including the cost of any equipment acquired in
connection therewith. 
 6.6 Option to Build Manufacturing Facility. At any time on or after the [*] anniversary of the
Effective Date, QMS may in its sole discretion decide to purchase, build or otherwise acquire a Manufacturing facility capable of producing the Licensed Products, in Uppsala, Sweden or on such other site as the Parties select (the “QMS
Facility”). 
 In the event QMS decides to move forward to purchase, build or otherwise acquire the QMS Facility, it
shall provide written notice to Q-Med of its intention to do so, and Q-Med agrees to meet with QMS to discuss in good faith the logistics involved in starting up such a Manufacturing operation. Q-Med further agrees to supervise the construction of
the Manufacturing facility and ensure that all relevant and necessary Manufacturing information is provided (the “Know How”). Q-Med will further validate the QMS Facility and the processes used and provide adequate documentation to
QMS to enable the QMS Facility to commence the Manufacture of Licensed Products in accordance with the applicable Specifications and GMP, for sale to QMS under this Agreement and for sale to Ireland under the Ireland Supply

  
  

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Agreement, provided appropriate safeguards are agreed to by the Parties to protect the confidentiality of the Know How both during and after the Term (the “Know How Agreement”).

 Once the QMS Facility is qualified by FDA, QMS will be entitled to utilize the QMS Facility exclusively as a source of supply
for the Licensed Products in the event of an uncured failure to supply by Q-Med under Section 6.4, or if Q-Med, on a voluntary or involuntary basis, declares bankruptcy. 
 QMS will pay for all costs and expenses in connection with the construction, establishment, qualification and maintenance of the QMS Facility, as well as all costs associated with its operation and will
also control the cost of goods produced in the QMS Facility. 
 Upon receipt of FDA approval to Manufacture Licensed Products at
the QMS Facility, QMS will assign a [*] ownership interest in the QMS Facility to Q-Med, but without any obligation on Q-Med’s part to make any capital contributions or otherwise be financially responsible for any costs associated with
operating the QMS Facility. In return for such interest, Q-Med will be responsible for staffing and managing the QMS Facility and shall remain in control of the Know How, subject to the terms and conditions of the Know How Agreement. 

In the event Q-Med provides evidence reasonably satisfactory to QMS that it will be able to provide [*] of Firm Orders to QMS for a
period of [*] consecutive months hereunder, QMS will then be obligated to purchase Licensed Products only from Q-Med and the Parties will then cooperate in good faith to keep the QMS Facility licensed and approved by FDA, at QMS’ sole cost.

  
  

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 QMS’ option to purchase, build or otherwise acquire a QMS Facility as described above
is in addition to any other rights and remedies QMS has under this Agreement in connection with a failure to supply by Q-Med under Section 6.4. QMS acknowledges that the QMS Facility may only be used to Manufacture Licensed Products and no
other NASHA Product. 
 At the termination or expiration of the License Agreements and the Supply
Agreements, for any reason whatsoever, other than because of a default by Q-Med, Q-Med shall have the option, exercisable in writing within [*] days after such termination or expiration, to acquire the QMS Facility and/or the equipment for cash, payable at
closing, at its book value (less the book value attributable to Q-Med’s ownership interest in the QMS Facility). In such event, the closing shall be held within [*] days after Q-Med’s election to acquire the QMS Facility. 

ARTICLE VII. 
 INSPECTION OF MANUFACTURING FACILITIES 
 7.1 Inspection Rights.

 (a) Q-Med shall provide QMS employees and/or Third Party representatives identified by QMS (“QMS inspectors”)
reasonable access upon reasonable prior notice to inspect, review and audit the Facility where the Licensed Products are being tested, handled, stored, distributed and/or Manufactured for the sole purpose of confirming that all Licensed

  
  

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Products for the Territory are tested, handled, stored, distributed and/or Manufactured in accordance with this Agreement. To the extent that in connection with such inspection any confidential
information is inspected, reviewed or audited, any QMS inspectors shall be bound by the confidentiality obligations described in Article 8 hereof and shall review and inspect the applicable Facility and records and meet with Q-Med’s personnel
solely for the purpose of confirming that Q-Med’s Manufacturing and record-keeping of its Manufacturing activities are compliant with this Agreement, the FDCA and with the requirements of comparable applicable Regulatory Authorities in the
Territory and/or regulations thereunder; provided that Q-Med has the option to delete or redact information not relating to the Licensed Products. Such inspections, reviews and audits shall occur upon not less than [*] days’ prior written
notice to Q-Med, shall only be conducted during normal business hours and shall not unreasonably disrupt the normal operations of Q-Med; provided that Q-Med shall be entitled to instruct QMS to conduct such inspection at an alternate date if Q-Med
is currently undergoing an inspection. Such inspections may be conducted only once every per year (it being understood that participation in or observing an FDA audit of Q-Med by QMS shall be considered a QMS inspection under this Article), except
that QMS may conduct follow-up inspections on less than [*] days’ notice directed at significant or critical quality issues observed during the any inspection or brought to QMS’ attention through customer complaints or FDA or other
comparable regulatory communications or enforcement actions or otherwise. 

  
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

48 

 (b) QMS will cause any Third Party representatives included in the QMS inspector group to
enter into agreements with Q-Med with respect to the proprietary and confidential nature of such information. Such Third Party representatives will be bound by such obligations and will follow such security and Facility access procedures as are
reasonably designated by Q-Med. Q-Med may require that at all times QMS inspectors be accompanied by a Q-Med representative and that QMS inspectors not enter areas of the Facility used in the production of the Licensed Products when products other
than Licensed Products are being Manufactured. 
 (c) Q-Med will provide QMS with access to relevant personnel during the audit
and Q-Med will provide a written response to any written audit observations provided by QMS within [*] days of Q-Med’s receipt thereof. In the event that the Facility is the subject of an audit or inspection by FDA or a similar Regulatory
Authority relating to the manufacture of a Licensed Product for QMS, Q-Med shall notify QMS, and if reasonably practicable under the circumstances QMS inspectors shall have the right to be present during such audit or inspection. The foregoing
notwithstanding, QMS’ regulatory affairs staff may with prior 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. QMS acknowledges that any
information provided to QMS during the course of such audit shall be deemed Confidential Information as defined in this Agreement. 
 (d) The Parties shall promptly notify one another when an FDA or comparable Regulatory Authority’s inspection of its facilities (or an inspection by Third Parties in accordance with the FDA or
comparable regulations in the Territory, as applicable, where such inspection pertains to the Licensed Products), is expected or underway, and will promptly 

  
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

49 

 
provide such other Party with copies of all regulatory correspondence, Establishment Inspection Reports, Form 483s, and Warning Letters issued by inspecting Regulatory Authority (or the Third
Party inspector) in connection with any such inspection and pertaining to Licensed Products in accordance with the terms of this Agreement. 
 (e) Nothing in this Section shall be deemed to obligate Q-Med to produce for inspection by QMS any information that Q-Med reasonably considers to be confidential and not necessary for QMS to fulfill its
obligations under the License Agreement, this Agreement or under applicable Laws. Notwithstanding the foregoing, QMS shall be entitled to review batch records, test methods and stability tests covering the Licensed Products. 

(f) QMS shall provide Q-Med or Q-Med’s representatives reasonable access upon reasonable prior notice to inspect, review and audit
QMS’ records reflecting (i) physician, patient or other relevant complaints about Licensed Products, received by QMS or QMS Purchasers, and (ii) the storage of Licensed Products by QMS or any party on QMS’ behalf. To the extent
that in connection with such inspection any confidential QMS information is inspected, reviewed or audited, any Q-Med representatives shall be bound by the confidentiality obligations described in Article 8 hereof. Such inspections, reviews and
audits shall occur upon reasonable prior written notice to QMS, shall only be conducted during normal business hours and shall not unreasonably disrupt the normal operations of QMS. 

(g) Q-Med will cause any Third Party representatives utilized in connection with an inspection, review or audit to enter into agreements
with QMS with respect to the proprietary and confidential nature of such information. Such representatives will be bound by such obligations and will follow such security and access procedures as are reasonably designated by QMS. 

  
 50 

 (h) The Parties understand and acknowledge that the inspection rights granted in this
Section 7.1 are duplicative of rights that have been granted to Ireland under the Ireland Supply Agreement and that such rights may only be exercised by either QMS Ireland (but not both). 

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 Products produced and Manufactured by Q-Med or its Affiliates or Subcontractors hereunder. Records shall be maintained for the longer of any period required under applicable Law or GMP, but in any event no less than
[*] 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 QMS such records (including making
copies thereof) without unreasonable delay to the extent reasonably requested and required by QMS to comply with its regulatory and other legal requirements. 
 ARTICLE VIII. 
 CONFIDENTIALITY 

8.1 Confidentiality. The terms and provisions of Article X of the 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 data and information disclosed pursuant to this Agreement, including all batch records, Certificates of Analysis and other information relating to the
Manufacture of the Licensed Products, shall be deemed “Confidential Information” of Q-Med and subject to the foregoing provisions. 

  
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

51 

 ARTICLE IX. 
 MISCELLANEOUS 
 9.1 Disclaimers. EXCEPT AS EXPRESSLY PROVIDED
IN SECTION 4.4 WITH RESPECT TO CERTAIN THIRD PARTY ACTIONS, IN NO EVENT SHALL EITHER PARTY OR THEIR AFFILIATES BE LIABLE FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR THEIR AFFILIATES, WHETHER BASED ON
CONTRACT, TORT OR ANY OTHER LEGAL THEORY; PROVIDED, HOWEVER, THE FOREGOING SHALL NOT LIMIT THE ABILITY OF AN INDEMNIFIED PARTY TO RECOVER SPECIAL DAMAGES PAID TO THIRD PARTIES AS PERMITTED UNDER SECTION 4.4 OF THIS AGREEMENT. 

9.2 Force Majeure. Neither Party shall be responsible or liable in any way for failure or delay in carrying out the terms
of this Agreement (other than any payment or confidentiality obligations) resulting from any cause or circumstance beyond its reasonable control, including acts of God, embargoes, fire, flood, other natural disasters, war, labor difficulties,
interruption of transit, accident, explosion, civil commotion, delays in performance or supplies from its suppliers and subcontractors (where such delays in performance or supplies are attributable to an event of force majeure suffered by such
supplier or subcontractor) and acts of any governmental authority (“Force Majeure”); provided, that the Party so affected shall give prompt notice thereof to the other including the period for which the Force Majeure is expected to
continue. Any time for performance hereunder (other than any time for payment) shall be extended by the actual time of delay caused by the Force Majeure event. Except as provided in the preceding sentence, no such failure or delay shall terminate
this Agreement, and each Party shall use its Commercially Reasonable Efforts to mitigate any damages incurred by the other Party as a result of the Force Majeure event and to complete its obligations hereunder as

  
 52 

 
promptly as reasonably practicable following cessation of the cause or circumstances of such failure or delay. In the event of delay due to any such cause, the date of delivery shall be adjusted
as may be reasonably necessary. QMS may cancel any Firm Order or Excess Order, in whole or in part, which cannot be completed due to any of the foregoing causes within sixty (60) days after the delivery date specified in such order. 

9.3 Governing Law; Jurisdiction; Arbitration and Venue. This Agreement and the exhibits and schedules hereto shall be governed by
and interpreted and enforced in accordance with the laws of the State of New York, without giving effect to any choice of law or conflict of laws rules or provisions (whether of the State of New York or any other jurisdiction) that would cause the
application of the laws of any jurisdiction other than the State of New York. Any dispute, controversy or claim arising out of or in connection with this contract, or the breach, termination or invalidity thereof, shall be finally settled by
arbitration in accordance with the Arbitration Rules of the Arbitration Institute of the Stockholm Chamber of Commerce. The arbitral tribunal shall be composed of three (3) arbitrators. The seat of arbitration shall be Stockholm, Sweden. The
language to be used in the arbitral proceedings shall be English. The foregoing notwithstanding, either Party may commence an Action to seek declaratory or equitable relief to enjoin a breach of threatened breach of this Agreement, which Action
shall be brought solely in the United States District Court for the Southern District of New York. 
 9.4 Assignment.

 (a) Neither this Agreement nor any of the rights and obligations arising hereunder may be assigned or transferred by either
Party by merger, sale of stock or assets, operation of law or otherwise, without the prior written consent of the other Party; provided, however, that (i) QMS may assign this Agreement without such consent in connection with the

  
 53 

 
sale or transfer of all or substantially all of the business or assets relating to or associated with the Licensed Field to any Third Party, whether by merger, sale of stock or assets, operation
of law or otherwise, provided that such assignment occurs in connection with a substantially contemporaneous permitted assignment of the Ireland Supply Agreement to the same assignee, (ii) the stock of QMS or QMS’ interest in this
Agreement may be collaterally pledged without such consent to a financial institution or syndicate of financial institutions represented by a single lenders’ agent to secure obligations to such lender(s) in connection with a bona fide financing
(the “QMS Pledge”), which pledge will include the right of the lender(s) and their assigns to foreclose upon such pledge, provided that such pledge occurs in connection with a substantially contemporaneous permitted pledge of
at least 65% of the voting stock of Ireland (“Ireland Control Stock”) to the same lenders represented by the same lenders’ agent (the “Ireland Pledge”), and provided further that, notwithstanding
any other provision hereof, unless such lenders foreclose upon both the QMS Pledge and the Ireland Pledge, and at all times after any such foreclosure the assignee of QMS’ interest in this Agreement is also the owner of the Ireland Control
Stock or an affiliate thereof, this Agreement shall immediately terminate upon notice thereof from Q-Med to QMS, and (iii) Q-Med may assign this Agreement without such consent to any Third Party which acquires all or substantially all of
Q-Med’s NASHA DX business, whether by merger, sale of stock or assets, operation of law or otherwise, provided that such assignment occurs in connection with a substantially contemporaneous permitted assignment by Q-Med of the Ireland
Supply Agreement to the same assignee. Any attempted assignment, sale or transfer in violation of the prior sentence will be void. Upon any permitted assignment or transfer of this Agreement by either Party, (i) the other Party shall be given
prompt written notice of such assignment, and (ii) the assignee shall agree in writing to be bound by the terms and conditions set forth herein. Notwithstanding the foregoing, either Party may assign this 

  
 54 

 Agreement 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. 
 (b) The rights and obligations of the Parties in the event of a Change of Control shall be governed by the provisions of Section 12.5 of the License Agreement. 

9.5 Notices. Any notice to be given by one Party to the other shall be in writing and shall be deemed given when delivered
by electronic mail or delivered personally (such notice to be effective on the date of transmission or delivery, as applicable), or sent by reputable international courier (such notice to be effective on the date which is three (3) Business
Days after the date of delivery to such courier), 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: General Counsel 
 Telephone: 011 46 18 474 90 00 

Telefax: 011 46 18 474 90 97 

With a copy to (which shall not constitute notice for purposes hereunder): 
 Michael L. Martell, Esq. 
 Morrison Cohen LLP 

909 Third Avenue, 27th Floor 
 New York, NY 10022 
 Telephone: 212.735.8652 

Telefax: 212.522.3152 

  
 55 

	If to QMS:	Q-Med Scandinavia Inc. 

 2035
Lincoln Highway 
 Edison, NJ 08817 
 Attention: Steven M. Bosacki 
 Telephone: 732.318.3801 

Telefax: 732.318.3801 
 With a
copy to (which shall not constitute notice for purposes hereunder): 
 Milbank, Tweed, Hadley & McCloy LLP 

One Chase Manhattan Plaza 
 New York, NY 10005-1413 
 Attention: Robert S. Reder, Esq. 

Telephone: 212.530.5680 
 Telefax: 212.530.5219 
 9.6 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. 
 9.7 Entire Agreement. This Agreement together with the License Agreement and the Quality 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, representations or understandings of the
Parties relating thereto. 
 9.8 Severability. The provisions of this Agreement are severable, and in the event
that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law in any jurisdiction or jurisdictions within the Territory, such invalidity or unenforceability shall not in any way affect
the validity or enforceability of the remaining provisions of this Agreement in such jurisdiction, provided that the essential purpose of this Agreement is not frustrated. 

  
 56 

 9.9 Expenses. Q-Med and QMS will each bear their own expenses and the expenses of
their respective Affiliates incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby. In connection with any Action brought to
enforce or invalidate any right or obligation arising hereunder, the Party against whom a judgment or arbitration award is entered shall, in addition to any other remedy awarded, be obligated to pay the prevailing Party all costs and expenses of its
prosecution or defense of such Action, including attorneys’ fees. 
 9.10 Further Actions. Q-Med and QMS 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. 
 9.11 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 QMS 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 QMS 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. 
 9.12 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 

  
 57 

 
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. 
 9.13 No Third Party Rights.
Other than with respect to the rights of the Q-Med Indemnified Parties and the QMS Indemnified Parties, 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. 
 9.14 Construction. This Agreement will be deemed to have been drafted by both Q-Med
and QMS and will not be construed against either Party as the draftsperson hereof. 
 9.15 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. 
 9.16
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. 

9.17 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. 

  
 58 

 9.18 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. 
 9.19
Consent to Jurisdiction. EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY (A) SUBMITS, FOR ITSELF AND ITS PROPERTY, TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK WITH RESPECT TO ANY
CLAIM SEEKING DECLARATORY OR EQUITABLE RELIEF ARISING UNDER OR RELATING TO THIS AGREEMENT; PROVIDED, HOWEVER, THAT SUCH CONSENT TO JURISDICTION IS SOLELY FOR THE PURPOSE REFERRED TO IN THIS SECTION 9.19 AND SHALL NOT BE DEEMED TO BE A
GENERAL SUBMISSION TO THE JURISDICTION OF SAID COURT OR IN THE STATE OF NEW YORK OTHER THAN FOR SUCH PURPOSE, (B) WAIVES PERSONAL SERVICE OF ANY AND ALL PROCESS UPON IT, (C) CONSENTS THAT ALL SERVICES OF PROCESS BE MADE BY REGISTERED OR
CERTIFIED MAIL, RETURN RECEIPT REQUESTED, DIRECTED TO IT AT ITS ADDRESS AS SET FORTH IN SECTION 9.5, AND (D) ACKNOWLEDGES THAT SERVICE SO MADE SHALL BE TREATED AS COMPLETED WHEN RECEIVED. EACH PARTY HERETO IRREVOCABLY WAIVES, TO THE FULLEST
EXTENT PERMITTED BY LAW, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE BASED ON FORUM NON CONVENIENS AND WAIVES ANY OBJECTION TO VENUE OF ANY ACTION INSTITUTED HEREUNDER. NOTHING IN THIS SECTION SHALL AFFECT THE RIGHT OF ANY PARTY HERETO TO SERVE
LEGAL PROCESS IN ANY OTHER MANNER PERMITTED BY LAW. 

  
 59 

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

			
	Q-MED AB
		
	By:	 	 /s/ Bengt Agerup

	Name:	 	Bengt Agerup
	Title:	 	CEO
	
	Q-MED SCANDINAVIA INC.
		
	By:	 	 /s/ Carina Bolin

	Name:	 	Carina Bolin
	Title:	 	Vice President

 [Signature Page –QMSI Supply Agreement] 

  
 60 

 SCHEDULE A 
 Intentionally Deleted 

  

 SCHEDULE B 
 SPECIFICATIONS 
 [*] 

 
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

  

 SCHEDULE C 
 CERTIFICATE OF ANALYSIS 
 [*] 

 
  

	*	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 SCHEDULE D 
 TERMS OF MANUFACTURING LICENSE 
 Upon QMS invoking its Manufacturing
License Option under Section 6.5 of the Supply Agreement, Q-Med and QMS shall enter into a manufacturing license agreement (“Manufacturing License Agreement”). The Manufacturing License Agreement shall include such customary
terms as Q-Med and QMS shall negotiate. 
 Under the Manufacturing License Agreement, QMS shall be granted a limited right to
sublicense to its Affiliates, and such Third Party contract Manufacturers that are approved by Q-Med in writing, the right to manufacture the Licensed Products, however, only for the account of QMS. QMS may not, however, sublicense the Manufacturing
rights to a Party that may be reasonably determined to be a competitor of Q-Med. 
 Under the Manufacturing License Agreement,
Q-Med shall be the sole owner of any improvements to any Q-Med Manufacturing technology, whether conceived of, created or developed by Q-Med and/or QMS. 
 Q-Med shall not be responsible for any Licensed Products Manufactured by or for QMS under the Manufacturing License Agreement, and Q-Med shall not have any warranty or indemnity obligations under the
Supply Agreements in respect of such Licensed Products, except for claims covered by Section 4.4(a)(ii)(A), as it relates to the design of Licensed Products only, and Section 4.4(a)(ii)(B), subject to Section 4.4(c). QMS shall not
Manufacture under the Manufacturing License Agreement any Licensed Products that have been withdrawn from the market by Q-Med for safety reasons. QMS shall indemnify Q-Med from all other liabilities arising out of the Manufacture of such Licensed
Products by or for QMS.

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