Document:

Supply Agreement between Q-Med AB and Cetacea Limited

 Exhibit 10.90 
 Portions of this exhibit marked [*] are omitted and 
 are requested to be treated
confidentially. 
 Execution Copy 
  

 
  

SUPPLY AGREEMENT 
 BETWEEN 
 CETACEA LIMITED

 AND 
 Q-MED AB 
  

 
  

 SUPPLY AGREEMENT 

This Supply Agreement (this “Agreement”) is entered into as of June 2, 2009 between CETACEA LIMITED, a
limited company organized under the laws of the Republic of Ireland (“Ireland”), 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 Ireland shall be referred to herein as a “Party” and collectively as the “Parties.” 
 BACKGROUND 
 Ireland 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 Ireland and its Affiliates and Sublicensees (each as defined in the License Agreement) with the Licensed Products, and Q-Med and
Ireland 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
Ireland” or similar wording means the point in time when Licensed Products are delivered to Ireland 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). 

  
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 “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, the applicable standards issued by the International Organization for Standardization, and the European Council Directive concerning Medical Devices
93/42/EEC. 
 “Ireland License Agreement” means the License Agreement, dated as of the date hereof, by and
between Q-Med and Ireland, as may be amended from time to time in accordance with the terms thereof. 
 “Ireland
Purchasers” means Ireland and any of its Affiliates and their permitted Sublicensees. 
 “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.

  
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 “Person” means any individual, firm, corporation, partnership, limited
liability company, trust, joint venture or other entity or organization. 
 “QMS License Agreement” means the
License Agreement, dated as of the date hereof, by and between Q-Med and Q-Med Scandinavia Inc. (“QMS”). 

“QMS Supply Agreement” means the Supply Agreement, dated as of the date hereof, by and between Q-Med and QMS.

 “Quality Agreement” means the Quality Agreement, dated as of the date hereof, by and between Q-Med
and Ireland, 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. 

  
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 “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 entire
world other than 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; 

  
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 (c) All definitions set forth herein shall be deemed applicable whether the words defined
are used herein in the singular or the plural; 
 (d) Unless otherwise provided, all references to Sections, Articles, 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. Ireland shall, and shall cause Ireland Purchasers to, purchase from Q-Med, and Q-Med shall Manufacture and supply to the Ireland 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 Ireland nor any of the Ireland 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. 

  
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 2.2 Forecasts. 

(a) Forecasts and Orders. On or before the last Business Day of each month, Ireland shall provide a forecast of the Ireland
Purchasers’ estimated monthly requirements of each commercially available Licensed Product for the [*]-month period beginning with the following month (a “Forecast”). Such beginning month of each Forecast shall be referred to
below as “Month 1” and each subsequent month shall be numbered sequentially. 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. 

 
  

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 (b) Failure to Purchase. If Ireland 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 Ireland and Ireland shall be required to purchase an amount equal to [*] of such applicable forecasted quantity. 

(c) Additional Quantities. Ireland 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 Ireland to Q-Med pursuant to this Section 2.2 shall be in
writing, which may be electronic. 
 (e) Alternative Ordering and Delivery Procedures. During both the period prior to and [*]
months after Ireland assumes all Commercialization responsibilities under the License Agreement for the Solesta Product and the Deflux Product in those countries where Q-Med and its Affiliates are selling the Solesta Product or the Deflux Product or
where either product is available as of the Effective Date, 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, Ireland Purchasers’ 

  
  

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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
example, if Ireland 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 Ireland 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. Ireland 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 Ireland 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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 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. Ireland 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 Regulatory Authority filing fees or other costs associated with any filings or changes made under this subsection shall be borne by Ireland. 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 Ireland’s consent, but Q-Med shall keep Ireland advised of its efforts to effectuate such changes consistent with Ireland’s position as the holder of the Regulatory Approval. 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 Ireland, 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 
  

 

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and shall provide to Ireland any information reasonably necessary for Ireland 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 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 Ireland, 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 Ireland’s consent, but Q-Med shall keep Ireland 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 Ireland. Q-Med shall be responsible for drafting relevant documentation and shall provide to Ireland any information reasonably

  
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necessary for Ireland to make appropriate filings with the applicable Regulatory Authority regarding such change, if applicable. Any 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 Ireland. If Ireland wishes to make any changes in the Specifications not necessary to comply with changes in GMP, Applicable Laws or other requirements of Governmental
Authorities, Ireland 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
Ireland) 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 Ireland and Q-Med reaching
agreement as to revisions, if any, to the Purchase Price (or one-time costs) necessitated by any such change. If Ireland 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. Ireland 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. Any Regulatory Authority
filing fees associated with the filings made under this subsection shall be borne by Ireland. 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 Ireland 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) Ireland 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 Ireland hereby consents to that change, subject to Regulatory Approval and such change shall not
result in any increase in the Purchase Price. Q-Med and Ireland 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 Ireland by Q-Med of the Solesta Product; (ii) Ireland 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 Ireland shall maintain a safety stock of at least [*] months demand of the Licensed
Products, based on the average quantities of Licensed Products ordered in Ireland’s last [*] monthly Firm Orders (the “Q-Med Safety Stock” or the “Ireland 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 Ireland, 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 Ireland’s ability to Commercialize Licensed Products (provided, however, that any change to a New Affiliate, New Subcontractor or New Facility
approved by the applicable Governmental Authority and effected after Q-Med secures any required Regulatory Approval, shall not be deemed to have a material adverse effect on Ireland’s 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 Ireland 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 are incorporated by reference in this Agreement, and
references to this “Agreement” herein shall be deemed to include the Quality 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. 

  
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 2.7 Certain Q-Med Obligations. 

(a) Conformity. All Licensed Products supplied hereunder shall be in finished form for Commercialization, and 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 Ireland 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 Ireland 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 Ireland of each Forecast, Q-Med will alert Ireland 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. 
 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 
  

 

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 (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 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 Ireland and Ireland may participate in the price negotiations with the Third Party Manufacturer. 
  

 

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 (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 Ireland 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 Ireland, 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. Ireland shall pay
the costs of such auditor. For the purpose of clarity, Ireland 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. 
 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 Ireland’s 

 
  

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submission of its first Forecast for such Licensed Product. If the Parties are unable to agree on the Purchase Price within [*] days after Ireland 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. 
 (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 Ireland 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 
  

 

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principal office in New York City, plus [*]. Notwithstanding the foregoing, if at any time Ireland 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 Ireland and at Ireland’s expense, make such arrangements for shipping and export as instructed by
Ireland and shall provide all export and import documentation within Q-Med’s control to provide, with respect to the Licensed Products. Ireland may designate up to nine (9) destinations, in total, for shipments of Licensed Products. Q-Med
shall not be required to ship the Licensed Products to more than such nine (9) destinations. If a shipment of Licensed Product ordered by Ireland 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 Ireland contains a variance of greater than plus or minus [*] of the quantity specified 
  

 

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in the corresponding Firm Order or Excess Order (a “Variant Shipment”), Ireland 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 Ireland’s 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 Ireland. In the case of a Variant Shipment that contains more than the quantity ordered, Ireland may elect to deduct
such excess deliveries from future Firm Orders. Notwithstanding the foregoing, Ireland 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. 

(b) Orders. Q-Med’s sales of Licensed Product shall be subject to the terms and limitations of this Agreement and not to any Ireland
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. 
  
  

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 (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. Ireland 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 Ireland, 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 of Ireland or any of its Affiliates or any carrier
after delivery by Q-Med in accordance with this Agreement (a “Visual Non-Conformity”). If Ireland 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 Ireland shall be deemed to have accepted the entire shipment and waived its right to reject the shipment based upon a Visual Non-Conformity. Ireland 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 
  

 

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rejection. Q-Med shall notify Ireland as promptly as reasonably possible, but in any event within [*] Business Days after receipt of such written notice, whether it agrees with Ireland’s
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
Ireland’s reasons for rejection and Q-Med shall replace such Licensed Products and shall reimburse Ireland for the cost of shipping (including insurance). If Q-Med does not agree with Ireland’s assertions and Ireland accepts Q-Med’s
determination, then Ireland shall be responsible for the price of the Licensed Product (including the shipping cost and insurance), and if Ireland 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 Ireland’s finding of a Visual Non-Conformity, Q-Med shall promptly supply Ireland 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 Ireland shall pay the applicable Purchase Price, subject to a credit if such dispute is resolved in Ireland’s favor. 

(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 Ireland’s attention that any Licensed Products
previously accepted may have a Latent Defect, Ireland shall provide prompt notice thereof to 
  

 

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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 Ireland at Q-Med’s Facility or New Facility, as the case may be, of the applicable Licensed Products to Ireland, 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 Ireland for the cost of shipping and insurance. If the cause of the Latent Defect is attributable to any other event, then Ireland
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). 

4.3 Warranties. 
 (a) Product Warranties. Q-Med warrants to Ireland: 
 (i) that Q-Med shall convey
good title to the Licensed Products, upon delivery of the Licensed Products to Ireland 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 (Ireland being responsible,
however, for any Labeling or other materials or instructions provided by Ireland in writing to Q-Med) within the meaning of Applicable Laws as of the time that the Licensed Product is transferred to the carrier at Q-Med’s shipping point; and

  
  

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 (iv) that the shelf-life of Licensed Products shipped to Ireland 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 Ireland or its designee; (2) have been stored or used in a manner contrary to Labeling after delivery to Ireland 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 Ireland’s 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. 

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 Ireland and its Affiliates and Sublicensees, and its and their
respective officers, directors, shareholders successors, assigns, 

  
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agents, employees and insurers in such capacity (collectively the “Ireland Indemnified Parties”) from and against any and all liability, claims, damages, losses or any reasonable
expenses (including attorneys’ fees, expert fees and costs of investigation incurred by Ireland), arising out of or relating to 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 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 Ireland unless and until the aggregate amount of Ireland Losses sustained in respect of matters within Q-Med’s Responsibility, including
any amounts paid by Ireland under Section 4.4(b)(ii), exceed $[*] (the “Threshold”) whereupon Q-Med’s liability shall be for amounts in excess of the Threshold; and 

 
  

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 (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, 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 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 Ireland 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 Ireland’s
Losses incurred by Ireland under Section 4.4(a)(ii) and this Section 4.4(b)(ii) exceed the Threshold, but nothing in this subsection (ii) shall be deemed to obligate Ireland 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; 

  
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 (iii) personal injury sustained by any patient through the use of a Licensed Product
proximately caused by acts or omissions of Ireland 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 Ireland, or by other acts or omissions of Ireland 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 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 Ireland, 

  
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or due to other acts or omissions of Ireland 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, 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 

 
  

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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 QMS
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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 4.5 Compliance with Laws. 

(a) General. Q-Med and Ireland shall each comply in all material respects with all Applicable Laws that pertain to the activities for
which Q-Med and Ireland 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 Ireland shall each operate in substantial compliance with requirements corresponding to
QSR requirements with respect to Licensed Products. Each Party shall bear its own costs and expenses related to such compliance. Q-Med shall promptly inform Ireland of any material issues raised by any Governmental Authority or a Notified Body, in
each case in connection with Manufacturing compliance for Licensed Products, and shall promptly provide Ireland 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 applicable 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 quality control requirements. Ireland
will similarly maintain all required registrations with all applicable 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. Ireland 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 Ireland, but
in that connection Ireland shall reasonably consult with Q-Med. Q-Med shall (i) cooperate fully with Ireland 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 Ireland 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, Ireland 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 Ireland any and all warning letters from a Regulatory Authority or Governmental Authority 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 a Regulatory Authority or Governmental Authority for debarment action or
(2) presently debarred under the regulations of Regulatory Authority or Governmental Authority. Q-Med shall promptly (but in all events within thirty (30) Business Days) of discovery) notify Ireland 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 Ireland Representations and Covenants. 
 (a) Ireland shall
promptly disclose to Q-Med any and all warning letters from a Regulatory Authority or Governmental Authority it receives with respect to the Licensed Products. 

  
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 (b) Neither Ireland nor any of its Affiliates or the employees thereof, or any of
Ireland’s independent sales force is, to Ireland’s knowledge, (i) under investigation by a Regulatory Authority or Governmental Authority for debarment action or (2) presently debarred under the regulations of a Regulatory
Authority or Governmental Authority. Ireland 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) Ireland 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 QMS 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 Ireland 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 Ireland, whereupon Ireland will pay Q-Med therefor in accordance with the terms of the Supply Agreement; 

(ii) For a period of [*] months following termination, Ireland 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 Ireland shall have the burden to establish, 

 
  

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 Ireland 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 Ireland’s 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 Ireland’s 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 Ireland shall thereafter cease any sales of the Licensed Products, or (2) permit Ireland for a period of [*] months after
termination to sell in the ordinary course of business any Licensed Products comprising Ireland’s 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 Ireland shall have the burden to establish, Ireland 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 Ireland’s obligation to report and pay applicable Royalties with respect to those sales). 

(ii) If Ireland 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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 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 Ireland shall have the burden to establish, Ireland 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 Ireland’s 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 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 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 obligations of confidentiality under Article 8 herein. Each Party shall not use or disclose to 
  

 

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 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 Ireland is selling off inventory pursuant to Section 6.3(a) over a [*] month period,
it may be necessary for Ireland 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 Ireland
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, Ireland 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, Ireland’s 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 QMS 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 QMS Supply Agreement shall be allocated on a pro-rata basis to the quantities shipped under Firm Orders under this Agreement and the QMS Supply Agreement
covering the same period. In the event a failure to supply occurs hereunder, Ireland may request that Q-Med appoint at Q-Med’s expense an additional Third Party Manufacturer of the Licensed Products, which may also be Ireland’s parent
company, namely, 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 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 
  
  

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

  
 42 

 Specifications and GMP for sale to Ireland under this Agreement and for sale to QMS under the QMS Supply
Agreement. Following the appointment of an additional Manufacturer, if [*] of Firm Orders are thereafter delivered to Ireland and under the QMS 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 QMS under the QMS Supply Agreement and that such rights may only be exercised by either Ireland or QMS (but not both) in the event of a failure to supply as described under Section 6.4(a). 

ARTICLE VII. 
 INSPECTION OF MANUFACTURING FACILITIES 
 7.1 Inspection Rights.

 (a) Q-Med shall provide Ireland employees and/or Third Party representatives identified by Ireland (“Ireland
inspectors”) reasonable access upon reasonable prior notice to inspect, review and audit the Facility where the Licensed Products are being tested, handled, 
  

 

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

  
 43 

 
stored, distributed and/or Manufactured for the sole purpose of confirming that all Licensed 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 Ireland 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, and the requirements of 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 Ireland 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 a Regulatory
Authority, by Ireland, shall be considered an Ireland inspection under this Article), except that Ireland 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 Ireland’s attention through customer complaints or regulatory communications or enforcement actions or otherwise. 
  

 

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

  
 44 

 (b) Ireland will cause any Third Party representatives included in the Ireland 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 Ireland inspectors be accompanied by a Q-Med representative and that Ireland 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 Ireland with access to relevant
personnel during the audit and Q-Med will provide a written response to any written audit observations provided by Ireland within [*] days of Q-Med’s receipt thereof. In the event that the Facility is the subject of an audit or inspection by a
Regulatory Authority relating to the manufacture of a Licensed Product for Ireland, Q-Med shall notify Ireland, and if reasonably practicable under the circumstances Ireland inspectors shall have the right to be present during such audit or
inspection. The foregoing notwithstanding, Ireland’s 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 Regulatory Authority visits. Ireland
acknowledges that any information provided to Ireland 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 a Regulatory Authority’s inspection of its facilities (or an inspection by Third Parties in accordance with applicable regulations in the
Territory, where such inspection pertains to the Licensed Products), is expected or underway, and will promptly provide such other Party with copies of all regulatory 

 
  

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

  
 45 

 
correspondence, Establishment Inspection Reports 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 Ireland any information that Q-Med reasonably considers to be confidential and not necessary for Ireland to fulfill its obligations under the License Agreement, this Agreement or under Applicable Laws.
Notwithstanding the foregoing, Ireland shall be entitled to review batch records, test methods and stability tests covering the Licensed Products. 
 (f) Ireland shall provide Q-Med or Q-Med’s representatives reasonable access upon reasonable prior notice to inspect, review and audit Ireland’s records reflecting (i) physician, patient or
other relevant complaints about Licensed Products, received by Ireland or Ireland Purchasers, and (ii) the storage of Licensed Products by Ireland or any party on Ireland’s behalf. To the extent that in connection with such inspection any
confidential Ireland 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 Ireland, shall only be conducted during normal business hours and shall not unreasonably disrupt the normal operations of Ireland. 
 (g) Q-Med will cause any Third Party representatives utilized in connection with an inspection, review or audit to enter into agreements with Ireland 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 Ireland. 

  
 46 

 (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 QMS under the QMS Supply Agreement and that such rights may only be exercised by either Ireland or QMS (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 Ireland such
records (including making copies thereof) without unreasonable delay to the extent reasonably requested and required by Ireland 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 filed separately with the SEC. 

  
 47 

 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

  
 48 

 
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. Ireland 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) Ireland may assign this Agreement without such consent in connection
with the 

  
 49 

 
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 QMS Supply Agreement to the same assignee, (ii) 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 pledge of the QMS Supply Agreement or of all of the voting stock of QMS 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 QMS’ interest in the QMS
Supply Agreement (whether directly or as assignee of all of the voting stock of QMS) 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 Ireland, 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 QMS 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 

  
 50 

 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. 
 (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 

  
 51 

	If to Ireland:	Oceana Therapeutics LLC 

 2035
Lincoln Highway 
 Edison, NJ 08817 
 Attention: Steven M. Bosacki 
 Telephone: 732.318.3811 

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 
 Attention: Robert S. Reder, Esq. 

Telephone: 212.530.5680 
 Telefax: 212.822.5680 
 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. 

  
 52 

 9.9 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 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 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. 
 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 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. 
 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 

  
 53 

 
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. 

9.13 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. 

9.14 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. 
 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.

  
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 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. 
 Remainder of Page Intentionally Left Blank 

  
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 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
	
	  
 CETACEA LIMITED

 

		
	By:	 	 /s/ Michael Greene

	Name:	 	Michael Greene
	Title:	 	Director

  

			
		
	By:	 	 /s/ Fergus McLoughlin

	Name:	 	Fergus McLoughlin
	Title:	 	Director

 [Signature Page – Ireland License Agreement] 

  

 SCHEDULE A 
 Intentionally Deleted 

  

 SCHEDULE B 
 SPECIFICATIONS 
 [*] 

 
  

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

  

 SCHEDULE C 
 CERTIFICATE OF ANALYSIS 
 [*] 

 
  

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

 SCHEDULE D 
 TERMS OF MANUFACTURING LICENSE 
 Upon Ireland invoking its Manufacturing
License Option under Section 6.5 of the Supply Agreement, Q-Med and Ireland shall enter into a manufacturing license agreement (“Manufacturing License Agreement”). The Manufacturing License Agreement shall include such
customary terms as Q-Med and Ireland shall negotiate. 
 Under the Manufacturing License Agreement, Ireland 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 Ireland. Ireland 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 Ireland. 

Q-Med shall not be responsible for any Licensed Products Manufactured by or for Ireland 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). Ireland shall not Manufacture under the Manufacturing License Agreement any Licensed Products that have been withdrawn from the market by Q-Med for safety reasons. Ireland shall indemnify
Q-Med from all other liabilities arising out of the Manufacture of such Licensed Products by or for Ireland.Manufacturing and Supply Agreement

 Exhibit 10.91 
 Portions of this exhibit marked [*] are omitted and 
 are requested to be treated
confidentially. 
 MANUFACTURING AND SUPPLY AGREEMENT 

 

	1.	Parties 

 Oceana
Therapeutics Limited Suite 602, Q House Sandyford 76 Furze Road Sandyford Industrial Estate Dublin 18 Ireland (hereinafter “Oceana”) 
 and 
 Bio Hospital AB, organization no. 556482-5544, Verkstadsvägen 63, 714 36
Koparberg (hereinafter “Bio Hospital”). 
  

	2.	Background 

  

	2.1.	Oceana is a medical device company that develops, markets and sells primarily implants for medical use. Implants are based on Q-Med AB’s patented technology
NASHATM. 

  

	2.2.	Bio Hospital is a medical technology company engaged in contract manufacturing of medical devices an in-vitro diagnostic disposable products. 

 

	2.3.	By signing this Agreement, all prior agreements and understandings, oral or written, between the Parties shall cease to apply unless otherwise specifically stated in
this Agreement. 

  

	3.	General guidelines for cooperation between the parties 

  

	3.1.	BioHospital shall manufacture and deliver products as specified in Enclosure 3.1.1 or other specifications as the parties may subsequently agreement.

 The following definitions will continue to be used in this Agreement, unless otherwise stated: 

 

			
	Product	  	Completed product packaged and approved for supply to Oceana’s clients or partners in accordance with applicable specifications.
		
	 Specifications

time-date version
	  	Enclosure 3.1.1 or other agreed specification in at each
		
	Batch	  	The quantity of product ordered by Oceana for the manufacture and supply at any one time delivery, not to be less than [*] units.
		
	Subcontractor	  	Any third party to Bio Hospital providing goods or services being included as part of the production of the product and the delivery of goods or services under this Agreement is
subject to Oceana’s written approval. All subcontractors are shown in Encl. 3.1.1.

  
  

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

	3.2.	Bio Hospital does not have the right, without Oceana’s prior written consent to appoint sub-contractors other than those stated by this Agreement and its
enclosures. If such Subcontractor shall be appointed Bio Hospital ensures that, in all respects the Subcontractor will act in accordance with the terms of this Agreement. Bio Hospital is always responsible for all sub-contractors’ acts and
omissions as for himself. 

  

	3.3.	Parties will comply with loyalty in business relationships, including among other things, that party shall promptly notify the other party if circumstances are or may
be of importance in business relations. In the event that circumstances surrounding the business relationship change, the parties shall work together to achieve a solution whereby the intention of the terms of this Agreement is maintained. The
Parties shall act jointly in order to shorten lead times and otherwise streamline the production and delivery process. 

  

	3.4.	Oceana has the right to unilaterally change the specification of at least three (3) months’ prior notice, to the extent that such amendment is made necessary
by circumstances beyond Oceana’s control. Other changes to the specification require written consent of both parties, which shall not unreasonably be refused. Such amendment shall be by application of the parties’ usual practice for
version control of the governing documents, and each Party shall designate suitable officers who are authorized to accept on behalf of the party new version of the specification. Oceana covers Bio Hospital for reasonable additional costs that Bio
Hospital incur as a result of changes to the specification demanded by Oceana. 

  

	4.	Bio Hospitals commitments 

  

	4.1.	Bio Hospital shall maintain an organization and have access to production capacity and raw materials in sufficient quantities to supply to Oceana at least to the extent
shown by Oceana at each time the current forecast for the next [*] months. Closer regulation of the forecast is made in paragraph 5 below. 

  

	4.2.	Bio Hospital shall ensure that the product delivered to Oceana meets the specifications as set out in Oceana’s order. 

 

	4.3.	Bio Hospital must keep adequate reference samples of critical raw materials as set out in the applicable specification. 

 
  

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

  
 2 

	5.	Forecasts 

  

	5.1.	Oceana shall before the beginning of each new calendar quarter, make projections of its projected orders for products over the next [*] calendar months. Forecast is
provided in the format agreed by the parties from time to time. Forecast shall specify the quantity of products Oceana calculates to order per calendar month. 

 

	5.2.	Specified quantities for the first [*] months of the Forecast shall be binding on Oceana, implying that Oceana agrees to order at least the quantity of product
specified in the forecast for those months. 

  

	5.3.	Party shall inform the other party of factors that can significantly affect future forecasts, orders and deliveries. 

 

	6.	Orders 

  

	6.1.	Orders from Oceana to Bio Hospital are to be written orders. The order shall at least include quantity and desired delivery date. 

 

	6.2.	Bio Hospital shall immediately, but not later than seven (7) days of receipt of order acknowledge the order according to 6.1 above. Such confirmation shall
indicate the quantity, location and date of delivery of the order. If such written confirmation has not been received by Oceana within seven (7) days from the time Bio Hospital received Oceana’s order, Bio Hospital shall be deemed to have
accepted the order in its entirety. 

  

	6.3.	Bio Hospital is obliged to accept any individual orders to the extent that they do not exceed the forecast quantity for months [*] to [*] of the forecast by more than
[*] or relates to a delivery to a desired delivery date less than [*] weeks from order date. 

  

	6.4.	For parties binding agreements for individual delivery occurs when the Bio Hospital accepted or deemed to have accepted the Oceana’s order. Bio Hospital is not
entitled to in its confirmation introduce new terms or otherwise modify Oceana’s orders in addition to that of this Agreement including its enclosures, and all such amendments shall be disregarded. In the event that Bio Hospital wishes to
change the Oceana’s order, in terms of quantity, delivery, or otherwise, Bio Hospital shall contact Oceana, immediately after receipt of order. To the extent that changes thereby are agreed Oceana will send another order to Bio Hospital.

  

	7.	Shipping and order 

  

	7.1.	Supply of Product according to binding orders should be made with delivery terms FAS, Incoterms 2000, the date specified in the order or prior to at the earliest three
(3) days before or within two (2) days thereafter. 

  

 

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

  
 3 

	7.2.	In the case of ordered quantity Bio Hospital is entitled to deviate at delivery [*] of Oceana’s order. Payment is made for the number of Products actually
delivered. 

  

	7.3.	Fulfillment of orders shall be deemed completed when the Oceana received the Product and related documentation, and specifications indicated samples and shipment
approval issued by the product according to Oceana’s routines. 

  

	7.4.	For delay in delivery which does not depend on Oceana, Bio Hospital shall pay a penalty to Oceana for each started seven-day period as the delay is, equivalent to [*]
of the price of the delayed delivery or part delivery, but not more than [*] of the price (i.e., the longest [*]). In addition, Oceana has the right to compensation for any damage; Oceana is suffering because of the delay, including any cost of
replacement, in case where the delay is caused intentionally or through gross negligence. 

 If the delay consists
of more than [*], Oceana has the right to cancel the order for the portion not delivered, and Bio Hospital shall be deemed to have materially breached its obligations under this Agreement. 

What the above states for liquidated damages shall not apply if Bio Hospital can show that the delay lies solely with the Subcontractor
and that Bio Hospital has taken such steps as may reasonably be required to ensure and procure the delivery by the subcontractor under the entered agreement. 
  

	7.5.	For delay in delivery where the delay is due to Oceana, the parties shall agree a new delivery date. 

 

	7.6.	Oceana has the right to complain about incorrect product throughout the product life under the applicable specification. If Oceana on reasonable grounds would have to
withdraw the delivered product from Customer, and the recall is based on defects in the product delivered to Oceana, Oceana shall have the right to complain the entire Batch from which the individual product came as the basis for recall.

  

	7.7.	With wrong product is meant product that do not meet all the criteria of the applicable Specification. Incorrect Product is returned to Bio Hospital or, if Bio Hospital
requests, is destroyed by Bio Hospital’s expense and risk. Oceana has the right to request that Bio Hospital as soon as possible, replace the faulty product with new or provide a price reduction. 

In addition, Bio Hospital pays Oceana for the direct damage that Oceana is suffering as a result of the erroneous delivery or part
delivery. 
  
  

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

  
 4 

	7.8.	Bio Hospital shall investigate complaints from Oceana. Within [*] working days from notification from Oceana, Bio Hospital shall come back with preliminary feedback. A
written notice, with the results of the investigation, correction actions for the current batch and preventive measures for future deliveries shall be provided within [*] days from Oceana’s notification. 

 

	7.9.	Bio Hospital shall ensure Oceana that from each Batch they will receive the number of samples as shown in the applicable specification. 

 

	8.	Price 

  

	8.1.	For deliveries of Product under this Agreement, Oceana is to pay the prices shown on Bio Hospitals Price List, Encl. 8.1. 

 

	8.2.	The price charged per unit, as specified in Encl. 8.1, should be based on Bio Hospital’s purchase price of the component in the form of needles which are purchased
from subcontractors added to Bio Hospital’s other costs for raw materials, components, labor, fix costs and margins. Since Bio Hospital purchases needles in US Dollars, the price charged to Oceana will also be in US Dollars. Either party has
also the right to [*] by [*] to call for renegotiation of the fixed part of the price for the [*] period beginning on [*]. Requests for renegotiation should be filed in writing, stating the adjustments required. The request must be justified by
referring to actual changes in the cost of the product, including both components as inputs and services. The party is also entitled, at any time, to request renegotiation of the price, if the party can show proof that the fixed component of the
price, will change by more than [*]% since the previous adjustment. 

  

	9.	Payment 

  

	9.1.	Bio Hospital has the right to invoice Oceana for Products on delivery. Oceana shall made payment within [*] days from the invoice date. For late payment Bio Hospital is
entitled to default interest rate. 

  

	10.	Bio Hospital’s Subcontractors 

  

	10.1.	Bio Hospital’s contract with a subcontractor Isotron BV is given in Encl. 10.1. Bio Hospital is not entitled to without Oceana’s approval to change the terms
of Chapter 5 of this Agreement. 

  

	10.2.	Bio Hospital is not entitled to substitute Subcontractor or otherwise let other than Subcontractor perform the tasks performed by the Subcontractor in this Agreement
without the input Oceana’s prior written approval. 

  

	10.3.	Bio Hospital shall ensure and document that there is a continuity plan for Bio Hospital and its subcontractors. 

 
  

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

  
 5 

	11.	Property rights, intellectual property rights, etc. 

  

	11.1.	All intellectual property rights relating to the Product shall be Oceana’s property. 

 

	11.2.	The Parties agree that all intellectual property used for Bio Hospitals production of Product, shall be Oceana’s property. Such property shall not without the
consent of Oceana be used by Bio Hospital for any purpose other than what is implied by this Agreement. At the termination of this Agreement, or upon request by Oceana, any such equipment, and related drawings, specifications, etc., shall be
delivered to Oceana. 

  

	12.	General Requirements for the Quality and Regulatory Support 

  

	12.1.	The requirements for quality are included in Encl. 12.1 Quality Agreement between the Oceana and Bio Hospital. 

 

	12.2.	Bio Hospital shall, upon request by Oceana, or Oceana’s licensees, provide the necessary, product-specific documentation that enables the acquisition of such
registration and permits necessary for products to be marketed and sold in countries where Oceana [is] operating or intending to work. Bio Hospital shall also observe and comply with other applicable regulatory requirements and guidelines relating
to the product and the activities Bio Hospital is to perform under this Agreement. 

  

	13.	Warranties and limitation of liability and insurance 

  

	13.1.	Bio Hospital ensures that the delivered product meets applicable specifications and other requirements set out in this Agreement including its enclosures, and that
manufacturing, sterilization and packaging are done accordingly, and also otherwise be done in a professional manner and in accordance with generally accepted industry standards. 

 

	14.	Term 

  

	14.1.	This Agreement is valid from the date of signature of both parties and to [*], after which the Agreement is extended by [*] year periods unless termination in writing
by any party within [*] months prior to end of each contract period. 

  

	15.	Transfer of production and the early termination 

  

	15.1.	In the event 

  

	 	a)	Bio Hospital or Subcontractor will become insolvent or fail to comply with obligations for deliveries under this Agreement, or 

 

	 	b)	ownership or structure is substantially modified, such as by merger with another company, so that Bio Hospital or Subcontractor is likely to come under the influence of
a third party with interests in accordance with Oceana’s assessment are contrary to Oceana’s interests, or 

  

 

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

  
 6 

	 	c)	Bio Hospital or Subcontractor of a major character breach of its obligations under this Agreement or if Oceana else has the right to terminate or cancel this Agreement

 Bio Hospital shall — on Oceana’s demand — actively and in good faith assist in Oceana to takeover
production of the product itself or to establish a similar production by a third party. 
  

	15.2.	Party has the right to immediately terminate the Agreement or portion thereof if 

 

	 	a)	the other party is declared bankrupt, takes up negotiations on the arrangement, subject to seizure, suspension of payments, reorganization or other circumstances likely
to be insolvent and there is reason to believe that the party will be unable to fulfill its obligations under this Agreement; 

  

	 	b)	the other party goes into liquidation, or 

  

	 	c)	a change in the other party’s ownership or structure, such as by merger with another company, likely to be against the interests of the party’s or

  

	 	d)	the other Party overrides their obligations under this Agreement and fails to make full correction within [*] days from receipt of written notice served.

  

	 	15.3.	Each party shall be entitled to compensation for direct damage, including fees for a replacement delivery, which arises in response to violations of conditions and
commitments under this Agreement. Party is never entitled to compensation for indirect damages such as lost profits. 

  

	16.	Privacy 

  

	16.1.	The parties shall not in any other context, use, or for third parties to disclose, any Confidential Information on the other’s activities as a party becomes aware.
Confidential Information means trade secrets and other information of technical and commercial matters obtained before or during the collaboration, which is governed by this Agreement. The Parties undertake to adopt all necessary measures to prevent
its employees from violating that commitment. 

  

	16.2.	Privacy under 16.1 above shall not include 

  

	 	a)	information, which is generally known or brought to public knowledge otherwise than by breach by the parties to the substance of this provision;

  
  

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

  
 7 

	 	b)	information that a party can show that the party already knew prior to receipt from the other party; 

 

	 	c)	information that a party has received or will receive from third parties, without being bound by confidentiality obligations in relation to him, or

  

	 	d)	information that a party under a court or other authority of a court order or decision is required to supply, provided that the party in good faith sought to avoid
this, and held other party informed. 

  

	17.	Other 

  

	17.1.	Bio Hospital is responsible for, and pays, insurance major disruption, fire, theft, liability and other circumstances that may cause harm to Oceana, including damage to
product or raw material in production that have not been Oceana’s property. Copy of current insurance and proof of insurance must be sent to Oceana on Oceana’s written request. At the signing of this Agreement, applicable insurance
provisions are contained in Encl. 17.1. 

  

	17.2.	At the termination of this Agreement, or otherwise when a party so requests, the other party shall immediately return all property and all Confidential Information
belonging to the first party and any other information as such party is entitled under the Agreement. In signing of this Agreement, Oceana does not hold any such property or confidential information about the Bio Hospital. Transmission of the
information also includes any copies of such information regardless of how the information is stored. 

  

	17.3.	Bio Hospital and Bio Hospital’s Subcontractors shall not use the Oceana’s name in connection with advertising and marketing without Oceana’s prior
written consent in each case. 

  

	17.4.	Changes and additions to this Agreement shall be in writing and properly drafted, and signed by the parties. 

 

	17.5.	Oceana has the right to assign its rights and obligations under this Agreement in the event of an assignment or licensing extensive product or other product where the
product is or is being packaged. In addition, the party is not entitled to assign this Agreement to another party without the other party’s prior written approval. 

 

	17.6.	If the party is unable to fulfill his obligation under this Contract by circumstances beyond his control that he could not reasonably be expected to be reckoned with at
the time of conclusion of the contract and whose consequences he could not reasonably have avoided or overcome, or that is suppliers were unable to perform the delivery because of such circumstances, this shall constitute a ground for postponement
of delivery or other performance and relief from penalties. 

  
 8 

	18.	Disputes and Applicable Law 

  

	18.1.	Irish law, except for choice of law rules, shall govern this Agreement and all transactions between the parties in respect of this Agreement. 

 

	18.2.	Disputes relating to validity, interpretation or application of this Agreement shall, as well as other disputes arising out of legal relationships because of it,
settled by Arbitration Court under the rules of the International Centre for Dispute Resolution. The arbitration shall be held in Dublin and shall be in English. 

 

	18.3.	To the extent that the plaintiff’s demands at the time the claimant of the arbitration process is lower than [*] US, the hearing shall have [*]. Otherwise, the
hearing shall be with [*]. 

 This Agreement has been signed in duplicate. 

 

									
	OCEANA	 		 	BIO HOSPITAL AB
					
	Place:	 	 Edison, NJ
	 		 	Place:	 	 Koppurberg

					
	Date: 	 	10/20/10	 		 	Date:	 	2010-07-01
	 Signature
	 		 	Signature
			
	 /s/ Andrew J. Einhorn
	 		 	 /s/ Ove Sahl

					
	Name	 	Andrew J. Einhorn	 		 	Name	 	Ove Sahl

 Enclosures: 
  

			
	Enclosure 3.1.1	  	Products and Specifications
	Enclosure 8.1	  	Price List
	Enclosure 10.1	  	Terms of Subcontractors (Isotron)
	Enclosure 12.1	  	Quality Agreement between the Oceana AB and Bio Hospital AB
	Enclosure 17.1	  	Insurance Certificate

  
  

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

  
 9 

 Enclosure 3.1.1 
 [*] 
  
  

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

  

 Enclosure 8.1 
 Prices 
  

							
	 Article
	  	Q-Med reference
number	  	Bio Hospital
reference 
number	  	Price per each unit
	 Deflux metal needle (EU)
	  	10-35811	  	QM10-35811	  	SEK [*]
	 Deflux metal needle (US)
	  	10-35810	  	QM10-35810	  	SEK [*]

 Prices 
  

							
	 Article
	  	Q-Med reference
number	  	Bio Hospital
reference 
number	  	Price per each unit
	 Deflux metal needle (EU)
	  	10-35811	  	QM10-35811	  	USD [*]
	 Deflux metal needle (US)
	  	10-35810	  	QM10-35810	  	USD [*]

  
  

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

 Enclosure 10.1 
 SERVICE AGREEMENT 
 This agreement is dated on 15 March 2008 and is made between
ISOTRON NEDERLAND B.V., authorised represented by Mr. G.C.V.E.G. von Ketelhodt, a company incorporated under the laws of the Netherlands and having its principal place of business at Ede and Etten-Leur - The Netherlands (hereafter ISOTRON), and
BIO-HOSPITAL AB, authorised represented by Mr. O. Sahl, being the customer having its principal place of business at Kopparberg - Sweden (hereafter “BIO-HOSPITAL”). 
 Both parties ISOTRON and BIO-HOSPITAL agree as follows: 
  

	1.	Definitions 

  

					
	- Service	  	:	    	Work and/or services to be performed by ISOTRON according to the specifications detailed under Schedule A.
			
	- ISOTRON	  	:	    	The company ISOTRON B.V. Ede and Etten-Leur, The Netherlands
			
	- BIO-HOSPITAL	  	:	    	The natural or legal entity who has given instructions and on whose account services will be provided, work will be carried out and goods will be supplied at his/their
expense.
			
	- Territory	  	:	    	The country or region in which the goods are treated.
			
	- Goods	  	:	    	Products of or on behalf of BIO-HOSPITAL to be treated by ISOTRON.

  

	2.	Confidentiality 

 2.1. 

ISOTRON shall not accept any confidential information from BIO-HOSPITAL except if ISOTRON gives its prior written approval to the communication of such
information as confidential. Any such confidential information shall not be used by ISOTRON or disclosed to third parties. 
 2.2. 

BIO-HOSPITAL shall not accept any confidential information from ISOTRON except if BIO-HOSPITAL gives its prior written approval to the communication of
such confidential information. In case of disclosure of confidential information, BIO-HOSPITAL is obliged to sign a Confidentiality Agreement, of which a duly signed copy is to be attached to this Agreement. 

  

 2.3. The obligations under 2.1 and 2.2 are not applicable in the event that the information specified:

  

	 	A)	can be shown to have been known by the receiving party prior to disclosure by the providing party; or 

 

	 	B)	comes into the public domain by publication or otherwise; or 

  

	 	C)	can be shown to have been made known to the receiving party from another source without being supplied either directly or indirectly by the providing party.

  

	3.	Schedules 

 Schedule A shall set
forth the specifications for the activities and/or services to be performed by ISOTRON. 
  

	4.	Service 

 4.1. 

BIO-HOSPITAL will offer to the Isotron facilities in Ede, the Netherlands, products for irradiation. These quantities will be delivered at the risk of
BIO-HOSPITAL at the sheds of ISOTRON Ede, the Netherlands according to the planning prepared by BIO-HOSPITAL logistics and agreed by ISOTRON and will remain in the ownership of BIO-HOSPITAL. However, during the presence of the Goods at ISOTRON
premises, ISOTRON will be liable for any damage, loss, theft, etc., according to article 11 of the General Conditions of Treatment and Sale. ISOTRON will make sure that her liability under those General Conditions of Treatment and Sale is covered by
an appropriate insurance, details of which will be given in the attached Schedule B. The Goods offered for irradiation must be delivered in a such a good condition that they can go through the total irradiation process, including all handling,
storage and transport, without causing any interruption of that process. 
 4.2. 
 ISOTRON will deliver the treated Goods ex warehouse at the treating facility and BIO-HOSPITAL has to collect the irradiated Goods, after having been notified by ISOTRON within 7 days as of notification by
fax. After expiration of this period ISOTRON shall charge BIO-HOSPITAL EUR 1.50 per pallet per week of storage. 
 4.3. 

In preparing the Goods, ISOTRON shall observe all applicable laws and regulations in effect in the Territory in particular, ISOTRON shall apply “Good
Manufacturing Practices”. 
 4.4. 

BIO-HOSPITAL will give orders to ISOTRON in writing quarterly forecast of quantities of goods to be irradiated. 

4.5. 
 ISOTRON shall treat such quantities of
the Goods as are specified in order confirmation notes issues by ISOTRON. Each order confirmation shall specify the quantities and delivery dates of the Goods to be processed by ISOTRON. 

  

	5.	Quality Control 

 5.1. 

ISOTRON shall have full responsibility for maintaining, at its own expense, suitable quality control functions at its manufacturing plant; such controls
shall meet the generally accepted standards of the industry and be in keeping with good irradiation practices. 
 5.2. 

ISOTRON shall supply BIO-HOSPITAL, upon request, with copies of manufacturing and control records with respect to any batch of the Goods, as and if
defined in separate standing operating instructions as annexed hereto under Schedule A. Furthermore, BIO-HOSPITAL’s representative shall have the right, at reasonable times and upon prior reasonable notice and accompanied by an authorised
representative of ISOTRON, to enter ISOTRON’s premises where the Goods are being processed to inspect such premises and the methods of processing and storage of the Goods during any stage of the irradiation process. Visits by BIO-HOSPITAL to
ISOTRON’s service facilities may involve the transfer of confidential information, which shall be subject to the terms of Article 2, above. 
 5.3. 
 ISOTRON will advise BIO-HOSPITAL, in writing, prior to a change in the irradiator which may
affect the dose distribution of the BIO-HOSPITAL products to allow BIO-HOSPITAL to perform any necessary requalification by means of a dose mapping. 
 5.4.  
 Source replenishments  

ISOTRON will inform BIO-HOSPITAL before source replenishments are performed at ISOTRON Ede. ISOTRON will inform BIO-HOSPITAL in writing, as soon as
possible after the replenishment of the source, that the replenishment has occurred, that the dose mapping has been performed according to the ISOTRON procedure and state whether the replenishment has affected the validated status for BIO-HOSPITAL.

  

	6.	Prices and Payment Terms 

 6.1.

 As of [*] BIO-HOSPITAL pays an irradiation tariff at [*] per pallet, for a minimum dose of [*] (kiloGray) and a maximum dose of [*] and a
density of [*] for [*]. As of [*] BIO-HOSPITAL pays an irradiation tariff at [*] per container, for a minimum dose of [*] (kiloGray) and a maximum dose of [*] and a density of [*] for [*]. 
 For [*] the prices will increase with [*]%, for [*] the prices will increase with [*]% and for [*] the prices will also increase with [*]%. BIO-HOSPITAL agrees to use ISOTRON’s irradiation services
initially for at least [*]% of the volume delivered to ISOTRON in [*]. 
  

 

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

  

 6.2. 
 Standard Payment Conditions, as mentioned in the General Conditions of Treatment and Sale, article 8, apply. Any specific conditions regarding payments must be mentioned hereunder: Not applicable.

  

	7.	Term and Termination 

 7.1.

 This agreement shall be entered into for three (3) years as of 15 March 2008. Six (6) months before the expiry date of the
agreement parties will convene and discuss the renewal of the present agreement. If no such meeting has been held the agreement will be automatically extended for one (1) full year. 
 7.2. 
 In the event that one Party shall at any time commit a material breach of any of the
provisions hereof and fails to cure such breach thirty (30) days after having received a written notice, the other Party may terminate this Agreement. 
 In case this breach is caused on the side of ISOTRON by reasons totally out of control of ISOTRON, e.g., fire or natural disasters, there will be no termination, but the agreement will be suspended only
for the period ISOTRON needs to restore a normal service situation. If this period exceeds six (5) months, the BIO-HOSPITAL is entitled to terminate the contract. 
 7.3. 
 This agreement shall terminate, without further notice or action if either Party should
become insolvent, or should make or seek to make an arrangement with, or an assignment for, the benefit of creditors, or if proceedings in voluntary or involuntary bankruptcy should be instituted by, on behalf of or against either party, or if a
receiver or trustee of either Party’s property shall be appointed. 
  

	8.	Effect of Termination 

 8.1.

 Termination shall not relieve or release either party hereto from making any and all payments which may be due and owing under the terms of
this agreement. 
 8.2. 
 Neither
ISOTRON nor BIO-HOSPITAL shall be liable for damages or indemnities, consequential damages, including, without limitation, goodwill indemnities, in any form by reason of termination of this agreement pursuant to its terms at any time or for any
reason. 
 8.3. 
 The provisions of
this Article and Article 2, 10 and 11 shall survive termination of this agreement for a period of five (5) years from such termination. 
  

	9.	Relationship between Parties 

 9.1.

 The relationship between ISOTRON and BIO-HOSPITAL is that of supplier and customer and under no circumstances shall either Party, its agents
and employees, or any authorised service 

  

 contractors of either Party be deemed agents or representatives of the other Party. Neither Party shall have
the right to enter into any contracts or commitments in the name of or on behalf of the other Party in any respect whatsoever. BIO-HOSPITAL does not have the right to resell or otherwise make available to third parties any contracted but unused
services at ISOTRON without written approval from ISOTRON to do so. 
  

	10.	Recalls, inspections and Products Complaints 

 10.1. 
 The Parties shall notify and cooperate with each other as to any and all complaints,
inspections and recalls concerning the Goods, as defined in ISOTRON’s General Conditions of Treatment and Sale. 
 10.2. 

In the event of a recall from the Goods, BIO-HOSPITAL shall assume complete responsibility for the conduct of the recall, except that ISOTRON shall
provide BIO-HOSPITAL with any service information reasonably required by BIO-HOSPITAL in connection with the recall. Liability for ISOTRON is limited to what is stated in article 11 of ISOTRON’s General Conditions of Treatment and Sale.

 10.3. 
 Other than in article 10.2,
ISOTRON can assume that Goods are to be found in good order after a period of [*] from the collection date, see article 4.2, has passed without complaints from BIO-HOSPITAL. 

 

	11.	Indemnity 

 11.1. 

The indemnity to be paid by ISOTRON is limited to what is sated in ISOTRON’s General Conditions of Treatment and Sale, see articles 10 and 11.

 11.2. 
 BIO-HOSPITAL shall indemnify
and hold ISOTRON, its successors and assignees harmless from and against any and all claims of liability, loss, damage, cost or expense (including reasonable fees for attorneys) relating to the BIO-HOSPITAL part of production, the marketing,
distribution, sale and use of the Goods. 
 11.3. 
 BIO-HOSPITAL will indemnify ISOTRON up to the guaranteed amount of turnover as stated in article 6.1, in case that turnover in the contract-period is lower due to a lower use of the services of ISOTRON.

  
  

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

  

	12.	Force Majeure 

 12.1. 

Neither Party shall be liable for damages to the other arising from the failure to perform the obligations assumed in this agreement when such failure to
perform shall be occasioned by any cause that does not belong to the risks that the contracting Party should usually bear in economic and social life. Such “Force Majeure” must, however, be formally declared in writing to the other Party
by one of the methods mentioned in article 13 hereunder. 
 12.2. If such “Force Majeure” occurs and lasts longer than 30 days, both
Parties are entitled to terminate the contract upon the terms as stated in the last section of article 7.2. 
  

	13.	Notices 

 13.1. 

All notices, designations of confidentiality, communications, demands, and payments required or permitted to be given or made hereunder or pursuant hereto
conclusively shall be presumed for all purposes of this agreement to be given or made at the time the same is personally given or made or at the time the same is transmitted by telex message, or at the time the same is transmitted by confirmed
telefax message, or two (2) days after the same is placed in an envelope and mailed by registered mail, prepaid, addressed as follows: 

If to ISOTRON: 
 Isotron Nederland B.V.

 P.O. Box 600 
 6710 BP Ede

 THE NETHERLANDS 
 If to
BIO-HOSPITAL: 
 BIO-HOSPITAL AB 

Verstadsvägen 63 
 71436 Kopparberg

 SWEDEN 
 or to such other address as
to which either Party hereto may notify the other Party hereto as aforesaid. 
  

	14.	Miscellaneous 

 14.1. 

This agreement shall be binding upon and inure to the benefit of the Parties hereto, their successors and assigns. All rights of either Party under this
agreement, unless otherwise specified herein, are personal and are not assignable without the consent in writing of the other Party being first obtained, except that upon written notice either Party may assign its rights and obligations under the
agreement to any of its subsidiaries or affiliates. 

  

 14.2. 
 All sales of Goods and Services by ISOTRON to BIO-HOSPITAL shall be subject to the provisions of this agreement and schedules A and B, and to the General Conditions of Treatment and Sale. 

14.3. 
 This agreement and the applicable
General conditions of Treatment and Sale constitute the entire agreement between the parties relating to the subject matter herein and all prior proposals, discussions and writings by and between the Parties are superseded. None of the terms of this
agreement shall be deemed to be waived by either Party or amended. Unless such waiver or amendment is in writing duly executed by both parties and such writing recites specifically that it is a waiver of or amendment to the terms of this agreement.

 14.4. 
 This agreement shall be
deemed to have been entered into in 15 March 2008, and its representations, its construction, and the remedies for its enforcement or breach are to be applied pursuant to and in accordance with the laws of the Netherlands. 

14.5. 
 Any dispute arising from this agreement
will exclusively be brought before the district court in Arnhem, the Netherlands, unless ISOTRON decides to sue before the competent Court of the domicile of the BIO-HOSPITAL. 
 14.6. 
 This agreement was written in English and is based upon the Dutch version of the
Service-Agreement. In case of any different interpretation between both versions, the Dutch version will prevail. 
 IN WITNESS WHEREOF, THE
PARTIES HAVE CAUSED THIS AGREEMENT TO BE DULY EXECUTED IN DUPLICATE AS OF THE DATE FIRST SET FORTH ABOVE. 
  

									
	BIO-HOSPITAL AB	 		 	Isotron Nederland B.V.
					
	By:	 	O. Sahl	 		 	By:	 	G.C.V.E.G. von Ketelhodt
					
	Title:	 	: Managing Director	 		 	Title:	 	Managing Director
					
	Signature:	 	 /s/ O. Sahl
	 		 	Signature:	 	 /s/ G.C.V.E.G. von Ketelhodt

  

 SCHEDULE A: GOODS & SPECIFICATIONS 

Not applicable. 
  

									
	BIO-HOSPITAL AB	 		 	Isotron Nederland B.V.
					
	Signature:	 	 /s/ O. Sahl
	 		 	Signature:	 	 /s/ G.C.V.E.G. von Ketelhodt

	By	 	: O. Sahl	 		 	By:	 	G.C.V.E.G. von Ketelhodt
	Title:	 	: Managing Director	 		 	Title:	 	Managing Director
	Date:	 	: [Illegible]	 		 	Date:	 	: [Illegible]

  

 SCHEDULE B: RELEVANT CURRENT INSURANCE POLICY DETAILS 

Mind out: One cannot derive rights from this enclosure 
 ISOTRON has insured her liabilities that might arise from the contract and the applicable General Conditions of Treatment and Sale. The insurance policy covers the following risks: 

 

	1.1	The risks as generally insured on the Nederlandse Beurs Brandpolis 1990, including supplementary conditions 1996: This policy includes cleaning up and salvage.

  

	1.2	The risks are summarily described as: airplane damage, hailstones, storm, break-in, blackmail and violent robbery, vandalism, unforeseen stream out of water and/or
stream, leakage of sprinkler- and/or gas extinguisher systems, precipitation (rain-, hail-, snow-, and melt water)., oil, smoke and soot, fall down of cranes, pile drivers, high installations, trees, windmills, and antennas, flag staffs and/or parts
of the above-mentioned matters, riots, disturbances and so on, neighbouring buildings, collision, glass breakage, cooling damage, landslip, air pressure, meteorites, own lack or decay. 

 

	1.3	Neither transport in ISOTRON’s name nor transport insurance is a part of the standard procedures. 

 

	1.4	Damage caused by forklift-trucks, etc. to goods treated or stored in the facility. 

 

	1.5	ISOTRON is insured for some kinds of damage caused by ISOTRON to goods of third parties when these are no longer in our care, for instance when an ISOTRON employee
causes damage to goods after these have been loaded in a lorry. 

  

	1.6	ISOTRON is insured in its capacity of a service irradiation company for legal responsibilities to persons and other companies, as required under Dutch law for Dutch
companies, the “Wettelijke Aansprakelijk-heidsverzekering”. 

  

	1.7	ISOTRON has limited insurance cover for damage to goods caused in the irradiation process, if such damage is caused by wrong parameter setting of the irradiation
equipment. 

  

 Enclosure 12.1 
 QUALITY AGREEMENT 
 By and between 

BIO HOSPITAL AB 

(Hereinafter referred to as “BIO HOSPITAL”) 
 and 
 OCEANA THERAPEUTICS LIMITED 

76 Furze Rd., Sandyford 
 Dublin 1, Ireland 
 (Hereinafter referred to as “OCEANA”) 

	1.0	SCOPE OF THIS AGREEMENT 

  

	 	1.1	This Quality Agreement (the “Quality Agreement”) defines the responsibilities of BIO HOSPITAL and OCEANA to ensure that the Processing of Product under
the Manufacturing and Supply Agreement by and between OCEANA and BIO HOSPITAL entered into as of the date of this Agreement (“MSA”) is in accordance with applicable Specifications, applicable parts of current Good Manufacturing Practices
(cGMP) and Regulatory Standards (each as defined herein). Should any requirement set forth in this Quality Agreement contradict applicable cGMP regulations, then the latter rules shall prevail. 

 

	 	1.2	It is understood that development stage/non commercial PRODUCT manufacture includes production up to and including batches manufactured for process validation. The
Agreement ensures that the manufacturing operations are in accordance with applicable parts of current Good Manufacturing Practice (cGMP) as required by the US FDA 21 CFR 820 regulations and the ISO13485 guidance with respect to the manufacture of
medical device and with either a regulatory filed or to be filed OCEANA approved synthetic process. 

  

	 	1.3	The arrangements relating to the contract manufacture of PRODUCT including but not limited to project proposals, nature of services, cost, invoicing and payment,
inventory ownership and inventions, indemnification, confidentiality, etc., were dealt within a separate agreement between MANUFACTURER and OCEANA (hereinafter called “Manufacturing and Supply Agreement, dated
            , 2010”), and in the event of any inconsistency between the terms and conditions of this Agreement and the terms and conditions of the Master Services Agreement between
MANUFACTURER and OCEANA, then the terms and conditions of the Master Services Agreement shall prevail. 

  
 - 2 -

	 	1.4	The appendices mentioned in this Quality Agreement, and all documents to which reference is made in the appendices shall become an integral part of this Quality
Agreement. 

  

	2.0	DEFINITIONS 

  

	 	2.1	Annual Product Review - shall mean an annual evaluation of the quality standards of the (in-process) and Finished Product to determine if changes in
Specifications, manufacturing or testing procedures are necessary. 

  

	 	2.2	Applicable Laws - shall mean all laws, ordinances, rules and regulations within the Territory applicable to the Processing of Product or any aspect thereof and
the obligations of BIO HOSPITAL, or OCEANA, as the context requires, including all applicable federal, state and local regulations in the Territory, all as amended from time to time, and including all regulations, rules, policies and guidelines
promulgated thereunder. 

  

	 	2.3	Current Good Manufacturing Practices - or the letters “GMP” or “cGMP” - shall mean current good manufacturing practice and standards as
provided for (and as amended or updated from time to time) in (i) the Current Good Manufacturing Practice Regulations of CFR Title 21, including those regulations set forth in 21 CFR Parts 210 and 211, (ii) European Community Directive
2003/94/EC (Principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use), and (iii) all other applicable Regulatory Authority rules, regulations,
policies and guidelines in effect at a given time and applicable ICH Harmonized Tripartite Guidelines. 

  
 - 3 -

	 	2.4	Executed Batch Record - shall mean production, control, test records and related documentation prepared for each batch of Product Processed and shall include
complete information relating to the production and control of each batch. 

  

	 	2.5	Facility - shall mean BIO HOSPITAL’s facilities located at or such other facility as agreed to in writing by the parties and that is identified in the
510(k) to Process Product. “Facilities” means those facilities collectively. 

  

	 	2.6	FDA - shall mean the United States Food and Drug Administration, and any successor entity thereto. 

 

	 	2.7	Final Packaging - shall mean the packaging and labeling of product in a form suitable for shipping and the transportation of Product under the specified
conditions and to OCEANA’s designated destinations. 

  

	 	2.8	Major Deviation - shall mean an extension from the Product Processing that potentially could have an effect on the quality of the Product. The excursion does
involve critical parameters. 

  

	 	2.9	Master Batch Record - shall mean written procedures for production and process control and testing designed to assure that each batch of Product Processed has
the identity, strength, potency, safety and purity they purport or are represented to possess and is used to ensure uniformity from batch to batch and compliance with cGMPs. 

  
 - 4 -

	 	2.10	Minor Deviation - shall mean an excursion from the Product Processing that has no effect on the quality of the Product. The excursion does not involve critical
parameters. 

  

	 	2.11	Process of Processing - shall mean the manufacturing, processing, testing, packaging and other activities undertaken or required to be undertaken by BIO HOSPITAL
in order to manufacture and supply OCEANA and/or its designees with Product, as applicable, in accordance with the Specifications, Regulatory Standards, and the terms and conditions set forth in this Quality Agreement. 

 

	 	2.12	Product - shall mean development stage/non-commercial medical device, processed in accordance with the applicable Specifications. 

 

	 	2.13	Raw Material - shall mean any other material or ingredients used in the Processing of Product. 

 

	 	2.14	Regulatory Authority - shall mean the FDA and/or any other governmental regulatory authority, court, arbitrator, agency, commission, official or other
instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign within the Territory, that performs a function for such political subdivision similar to the function performed by the FDA for the United with
regard to the approval, licensing, registration or authorization of any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product. 

 

	 	2.15	Regulatory Standards - shall mean (i) obtaining and maintaining any and all permits, licenses, filings and certifications required by Regulatory
Authorities, (ii) compliance with cGMPs applicable to any Processing activities or Facilities, and (iii) all Applicable Laws that apply to any Processing or Facilities. 

  
 - 5 -

	 	2.16	Specifications - shall mean those critical quality standards and procedures as defined in the regulatory filing, as amended from time to time, for the Product,
where such standards include the acceptance criteria and tests or procedures used to assess conformance thereto, as well as those additional approved criteria for in-process, periodic, skip, or other tests and procedures, e.g., such as are
periodically performed to assess stability, including such standards and procedures as are set forth in this Quality Agreement. 

  

	 	2.17	Standard Operating Procedures - shall mean the standard operating procedures in effect at BIO HOSPITAL which have been approved by BIO HOSPITAL’s Quality
Assurance department and which are applicable to the Processing. 

  

	3.0	PROCESSING 

  

	 	3.1	BIO HOSPITAL shall be responsible for Processing Product in conformity with applicable Specifications, cGMP, and Regulatory Standards. 

 

	 	3.2	Subject to Section 12, (a)d BIO HOSPITAL shall determine through its testing and review of the Product the latter’s suitability for release, and BIO HOSPITAL
shall disposition the Product for supply to OCEANA and/or its designees when such suitability is demonstrated and (b) OCEANA shall be responsible for the final disposition of the Product. 

 

	 	3.3	BIO HOSPITAL shall maintain an effective Device quality system to ensure that the Product is processed according to the Specifications and in compliance with cGMP
regulations and applicable Regulatory Standards. 

  

	 	3.4	 BIO HOSPITAL shall validate all processes, methods, equipment, utilities, facilities and computers used in the Processing of Product in conformity with
cGMP 

  
 - 6 -

	 	
regulations, especially US federal regulation 21 CFR 211 and as required by applicable Regulatory Standards so as to ensure that Processing is able to commence in accordance with such regulations
and standards and in conformity with the Specifications. 

  

	 	3.5	BIO HOSPITAL declares that it is in possession of all authorization(s) necessary to carry out Processing at the time of entering into this Quality Agreement. BIO
HOSPITAL shall ensure that these authorizations are retained unconditionally during the term of this Quality Agreement and the MSA and shall provide such authorizations to OCEANA when requested by OCEANA by submitting relevant documentation to
OCEANA. 

  

	4.0	RAW MATERIALS 

  

	 	4.1	BIO HOSPITAL shall be responsible for supplying and for approving the quality of all the Raw Materials and suitability of the suppliers selected by BIO HOSPITAL. OCEANA
shall be responsible for the quality of material provided by and suitability of suppliers selected OCEANA. 

  

	5.0	MEDICAL DEVICE 

  

	 	5.1	BIO HOSPITAL and OCEANA shall be responsible for supplying and approving the specifications of MEDICAL, DEVICE and suitability of the suppliers thereof.

  

	6.0	INSTRUCTIONS FOR THE PROCESSING 

  

	 	6.1	BIO HOSPITAL shall Process Product in conformity with the applicable Specifications and Master Batch Record, and in compliance with cGMP regulations and applicable
regulatory Standards, for all stages of Processing. 

  
 - 7 -

	 	6.2	Those employees of the Parties named as responsible persons for Processing, Quality Assurance, Quality Control and Product release as well as employees named as contact
partners in the logistics function are specified in Appendix III. Both Parties must be informed immediately in writing of any changes in the fields of responsibility of the responsible persons and/or contact partner, should these occur.

  

	 	6.3	The Device responsibilities of the parties shall be as set out in Appendix II. 

 

	7.0	BATCH NUMBER 

  

	 	7.1	BIO HOSPITAL batch number shall be used for numbering each batch of Product. The number shall appear on all documents related to the particular batch of the Product.

  

	8.0	MANUFACTURING AND EXPIRATION RETEST DATES 

  

	 	8.2	The shelf life of the Product starts from the date of manufacture and shall be assigned by BIO HOSPITAL based on ICH stability data. 

 

	9.0	CHANGE CONTROL/DEVIATIONS 

  

	 	9.1	BIO HOSPITAL shall obtain OCEANA’ written content prior to implementing any product specific changes recommended by BIO HOSPITAL to the Processing and/or
Specifications of Product. 

  

	 	9.2	OCEANA and BIO HOSPITAL shall assess and approve any product specific planned change or planned deviation from the manufacturing process. 

 

	 	9.3	Minor deviations from the manufacturing process shall be carefully documented and approved by appropriate BIO HOSPITAL QA manager or designee. 

 

	 	9.4	 BIO HOSPITAL shall inform OCEANA of all major deviations from the manufacturing / packaging process within 24 hours of either its occurrence or

  
 - 8 -

	 	
knowledge of its occurrence. Where there is product impact, BIO HOSPITAL, with OCEANA’ involvement shall assess each major deviation with regard to its potential effect on the quality of the
Product. BIO HOSPITAL and OCEANA shall approve all documentation describing and resolving each major deviation including any Corrective and Preventive Action (CAPA) reports resulting there from. 

 

	10.0	QUALITY CONTROL AND SAMPLING 

  

	 	10.1	During Processing of Product, BIO HOSPITAL shall draw representative samples according to cGMP. 

 

	11.0	RESERVE SAMPLES 

  

	 	11.1	 BIO HOSPITAL shall sample, store and maintain appropriate reserve samples (identified by Batch number) (the “Reserve Samples”) of
(i) Product and (ii) all Raw Materials used to Process or package Product, in accordance with cGMP and other US federal requirements including 21 CFR 211.170 (b), and in each case with respect to quantities as set forth in the
Specifications attached hereto and stored under conditions and in the same immediate container-closure system as defined in the Specifications. If additional reserve samples are required the parties will jointly determine and agree upon what
additional cost is appropriate to store such samples in excess of the current Specifications. Reserve Samples of Product from each batch of Product to permit at least two (2) full re-examinations. Reserve Samples of each batch of Product shall
be retained for at least two (2) years after the expiration date of the respective batch. BIO HOSPITAL shall notify OCEANA that Product is approaching expiration and if OCEANA requests the Reserve Samples, OCEANA shall inform BIO HOSPITAL where
the Reserve Samples shall be sent. The Reserve 

  
 - 9 -

	 	
Samples shall be visually inspected by BIO HOSPITAL at least once a year for evidence of deterioration. BIO HOSPITAL shall record the results of such inspection, as required by cGMP regulations,
especially US federal regulation 21 CFR 211.170 (b). BIO HOSPITAL shall provide OCEANA and any Regulatory Authority with reasonable access to any portions of the Reserve Samples for testing and other purposes upon OCEANA’ request.

  

	12.0	BATCH DOCUMENTATION 

  

	 	12.1	 BIO HOSPITAL shall document the conduct of all the procedural steps stipulated in the Master Batch record as well as all in-process controls in
Batch-specific records as customarily kept by BIO HOSPITAL. BIO HOSPITAL provide OCEANA with timely notification of al significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the
product, as well as copies of all FDA correspondence regarding Processing. The Quality Assurance Department of BIO HOSPITAL shall be responsible for determining Product batch suitability for approval for each batch of the Product. BIO HOSPITAL shall
provide OCEANA with a complete copy of the Executed Batch Records in English. Such records shall be provided to OCEANA prior to shipment of such Batches. OCEANA Quality Assurance shall have no more than 15 business days to review the Executed Batch
Records. OCEANA Quality assurance shall provide disposition of Product to BIO HOSPITAL Quality Assurance before shipment of Product can occur. OCEANA shall be responsible for the final disposition of each PRODUCT batch. The Executed Batch records
must be accompanied by a Certificate of Compliance (COC) / Certificate of Release (COR) and a Certificate of Analysis (COA) for the 

  
 - 10 -

	 	
Product. Deviation and Out of Specification (OOS) reports shall be included if applicable, which detail in writing any problems and deviations within Processing. BIO HOSPITAL shall retain the
complete Batch documentation for at least one (1) year after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21 CFR 211.180. BIO HOSPITAL shall provide copies of these records to
OCEANA on reasonable request. BIO HOSPITAL shall notify OCEANA prior to destruction of documents and provide them to OCEANA if requested. 

  

	 	12.2	BIO HOSPITAL shall present Processing documentation to Regulatory Authorities upon request as appropriate and in the manner required by cGMP regulations, especially US
federal regulation 21 CFR 211.180(c) and (d). 

  

	13.0	STABILITY 

  

	 	13.1	If a stability program should be required BIO HOSPITAL shall be responsible for the stability program for the PRODUCT. Such stability protocol would be consistent with
the ICH Q1A (R2) and Q1B guidance. 

  

	14.0	DOCUMENTATION 

  

	 	14.1	Table 1 summarizes the types of documents that shall be supplied by one party to the other, as applicable and indicates whether these documents are approved jointly or
solely by OCEANA and/or BIO HOSPITAL. 

  
 - 11 -

 Table 1 Document Listing 

 

					
	  	  	REQUIRED APPROVAL
	 DOCUMENT
	  	OCEANA
or
DESIGNEE	  	BIO
HOSPITAL
			
	Master Batch Record	  	X	  	X
			
	Executed Batch Record (EBR)	  	X	  	X
			
	Specifications for Raw Materials	  	X	  	X
			
	Specifications for MEDICAL DEVICE	  	X	  	X
			
	Specifications for PRODUCT	  	X	  	X
			
	Specifications for PRODUCT	  	X	  	
			
	Packaging/Container closure	  		  	
			
	Specifications for Labeling	  	X	  	X
			
	Written Justifications for Specifications	  	X	  	X
			
	Certificates of Analysis	  		  	X
			
	Certificates of Compliance / Release	  		  	X
			
	Analytical Methods for in-process control testing	  		  	X
			
	Analytical Methods for PRODUCT testing	  	X	  	X
			
	Analytical Validation Protocols	  	X	  	X
			
	Analytical Validation Reports	  	X	  	X
			
	Analytical Method Transfer Protocols	  	X	  	X
			
	Analytical Method Transfer Reports	  	X	  	X
			
	Stability Study Protocols and Reports	  	X	  	X
			
	Stability Study Results	  	X	  	X
			
	Investigation Reports for major batch manufacture deviations	  	X	  	X
			
	Investigations for Confirmed Out of Specifications	  	X	  	X
			
	Major Change Control Results	  	X	  	X
			
	Equipment Cleaning Validations	  		  	X
			
	Process Validation Protocols	  	X	  	X
			
	Process Validation Reports	  	X	  	X

  
 - 12 -

	 	15.0	COMPLAINTS 

 BIO HOSPITAL and
OCEANA jointly are responsible for and shall cooperate in conducting and documenting internal investigations of, and response to, customer complaints. 
 Emergency contact numbers for BIO HOSPITAL and OCEANA are outlined in Appendix III attached hereto and shall be updated in the event of a change. 

OCEANA shall forward to BIO HOSPITAL Product complaints about the quality of the Product(s) after confirming by investigation the details
and authenticity. All authenticated complaints shall be forwarded to BIO HOSPITAL for internal investigation; all other complaints, and the results of investigation determining same, shall be maintained by OCEANA and forwarded to BIO HOSPITAL upon
request. For authenticated complaints, BIO HOSPITAL shall review without undue delay the respective Batch documentation, carry out tests to clarify the cause of such a complaint, its alleged technical defect and present OCEANA with a response
summarizing the results of such investigation. The final response has to be sent to OCEANA within thirty (30) calendar days of receipt of the Product complaint. For Product complaints where the nature of the complaint is such that patient
safety could be put at risk, preliminary 

  
 - 13 -

 
investigation statements must be available within two (2) Business Days of receipt, a final statement must be written without any undue delay, within ten (10) calendar days at the
latest. The final response must also include details on the confirmed or assumed causes of technical defect(s) when applicable. BIO HOSPITAL shall be responsible for the appropriate measures to prevent the re-occurrence of any such defects and
report such measures in the final response. If for any reason items remain outstanding, BIO HOSPITAL shall provide periodic progress updates. BIO HOSPITAL and OCEANA shall agree on the frequency on a case by case basis. 

 

	16.0	RECALLS AND OTHER CORRECTIVE ACTIONS 

  

	 	16.1	In the event BIO HOSPITAL believes a recall, field alert, Product withdrawal or field correction (any of the foregoing, a “Recall”) may be necessary with
respect to any Product, BIO HOSPITAL shall immediately contact OCEANA to discuss their belief. BIO HOSPITAL shall not act to initiate a Recall without the express prior written approval of OCEANA, unless otherwise required by Applicable Laws. In the
event OCEANA believes a Recall may be necessary with respect to any Product, OCEANA shall immediately notify BIO HOSPITAL to discuss its belief and BIO HOSPITAL shall provide all necessary cooperation and assistance to OCEANA. Unless otherwise set
forth herein, OCEANA shall have responsibility for and shall make all decisions relating to conducting any Recall related to Product in the Territory. INVDEVUS shall notify BIO HOSPITAL of the decision to initiate a regulatory action prior to
notification to the regulatory agency whenever possible. 

  
 - 14 -

	17.0	STORAGE 

 BIO HOSPITAL
shall be responsible for quality of the Product during storage and handling. OCEANA shall be responsible for the quality of the Product consistent with delivery terms FAS, Incoterms 2000. 

 

	18.0	INSPECTIONS AND AUDITS 

BIO HOSPITAL immediately advise OCEANA if any Regulatory Authority communicates with BIO HOSPITAL or visits or inspects any Facility
directly related to the Product. Representatives of OCEANA shall have the right to be present at BIO HOSPITAL’s Facility and participate as mutually agreed during any such inspection. BIO HOSPITAL shall furnish to OCEANA a copy of applicable
portions of all reports and communications by such Regulatory Authority (including any FDA Form 483 or other establishment inspection reports, warning letters, citations, indictments, claims, lawsuits or proceedings issued or instituted against BIO
HOSPITAL or any subcontractor, or of any revocation of any license or permit issued to BIO HOSPITAL or such subcontractor that affect Product or any Facility directly applicable to the product, or that relates to any license or permit issued to BIO
HOSPITAL in connection with the Product or any Facility, when such reports and correspondence become available to BIO HOSPITAL, but in any event within three (3) days of BIO HOSPITAL’s receipt thereof. BIO HOSPITAL shall discuss with
OCEANA any Regulatory Authority comments related to and affecting any Processing or the ability of BIO HOSPITAL to perform its obligations hereunder, and before BIO HOSPITAL submits a response to such comments, BIO HOSPITAL shall give OCEANA no
greater than five (5) Business Days to comment on its proposed response to such comments, and BIO HOSPITAL shall give reasonable consideration to incorporating any resultant OCEANA comments specific to

  
 - 15 -

 
the Processing of a Product. BIO HOSPITAL shall promptly rectify or resolve any deficiencies noted by a Regulatory Authority in a report or correspondence issued to BIO HOSPITAL that relate to
any Processing activities. BIO HOSPITAL shall send updates to OCEANA every two (2) days if such inspections are extended. 

OCEANA shall have the right twice every two (2) years, through one but no more than two (unless mutually agreed) representatives or
designees during normal mutually agreed upon business hours, and upon at least ten (10) business Days written notice to BIO HOSPITAL, to inspect and audit in a reasonable manner (a) those portions of the Facilities in which any processing
is conducted and (b) any of BIO HOSPITAL’s or its subcontractors’ manufacturing and quality control records and other Documentation relating to the Processing activities in order to ensure BIO HOSPITAL’s compliance with its
obligations under this Quality Agreement; review correspondence, reports, filings and other documents from or to Regulatory Authorities to the extent related to Processing activities; and evaluate all variances from applicable Regulatory Standards,
or this Quality Agreement; provided that (i) any such representative or designee shall be subject to the same confidentiality restrictions as OCEANA and (ii) OCEANA shall be responsible to BIO HOSPITAL for any breach by any such
representative of such confidentiality restrictions. In the event of a safety or health or potential safety or health or other emergency related to the Product, BIO HOSPITAL shall use commercially reasonable efforts, in good faith and commensurate
with the urgency of the circumstances, to allow OCEANA to initiate any inspection and audit under this section (which shall be in addition to any annual inspection referred to in the first sentence of this Section) at a mutually agreed upon time
upon forty-eight (48) hours notice during regular 

  
 - 16 -

 
business hours. BIO HOSPITAL shall promptly correct any mutually agreed problems or issues identified as a result of any such inspection or audit to the extent that such problems or issues result
from a failure to comply with cGMPs or other applicable Regulatory Standards. BIO HOSPITAL shall provide OCEANA with reasonable documentary and other evidence of such corrections 

 

	19.0	ANNUAL PRODUCT REVIEW 

  

	 	19.1	In consultation with OCEANA, BIO HOSPITAL shall provide information upon request for an Annual Product Review. The content of the Annual Product Review shall be agreed
to by both OCEANA and BIO HOSPITAL. 

  

	20.0	SUB CONTRACTING 

  

	 	20.1	BIO HOSPITAL may subcontract any of the work entrusted to it OCEANA if the subcontractor has been fully qualified as a vendor and BIO HOSPITAL has the prior written
authorization of OCEANA. 

  

	21.0	DURATION OF THE AGREEMENT 

  

	 	21.1	This Quality Agreement shall commence from the date of signing and shall remain in force until expiration or termination of the MSA. 

 

	22.0	AMENDMENTS 

  

	 	22.1	This Quality Agreement and the appendices hereto may be revised from time to time, but only upon mutual written agreement of the Parties. 

 

	23.0	OTHER PROVISIONS 

  

	 	23.1	 The terms of this Quality Agreement are intended to supplement (but not limit) the terms of the MSA, and with regard to all other issues not mentioned
herein the respective provisions of the MSA shall apply. In the event of conflict between any of 

  
 - 17 -

	 	
the provisions of this Agreement and the Supply Agreement with respect to quality-related activities, including compliance with Good Manufacturing Practices and all other regulatory obligations
as they pertain to the Product, the provisions of this Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Supply Agreement with respect to any commercial matters, including allocations of risk,
liability and financial responsibility, the provisions of the Supply Agreement shall govern. Notwithstanding the foregoing, in the event that additional services are added to this Agreement requiring a modification in the scope of services provided,
and as a result, in the pricing set forth in this agreement and/or the Supply Agreement, the parties shall agree to such modifications in writing. 

  
 - 18 -

 IN WITNESS WHEREOF, BIO HOSPITAL and OCEANA have executed this Agreement by their respective duly authorized
representatives on the date set forth below: 
  

			
	OCEANA THERAPEUTICS LIMITED
		
	By:	 	 /s/ Andrew J. Einhorn

	Name:	 	 Andrew J. Einhorn

	Title:	 	 Chief Financial Officer

	Date:	 	 10/14/10

	
	BIO HOSPITAL AB
		
	By:	 	 /s/ Ove Sahl

	Name:	 	 Ove Sahl

	Title:	 	 General Manager

	Date:	 	 10/18/10

  
 - 19 -

 Enclosure 17.1 
 Translation from Swedish to English 
  

					
	Insurance Policy	 	Dated March 10, 2010	 	

  

			
	 Insurance Valid
	  	from May 1, 2010 - April 30, 2011
	 Policy Holder
	  	Bio Hospital AB
	 Insured Operation
	  	Workshop/Manufacturing
		  	- annual compensation $[*] and annual turnover $[*]

  

					
	 Property Insurance
	  	Insurance Amount	 
	 Fire, burglary and water damage
	  			
		
	 Physical address of location
	  			
	 1. Machines in the workshop location
	  	$	[	*] 
	 2. Goods in the workshop location
	  	$	[	*] 
	 3. Customer’s property in the workshop
	  	$	[	*] 
	 4. Machines in the office workshop
	  	$	[	*] 
	 5. Computers in the office
	  	$	[	*] 
	 6. Customer’s property in the office workshop
	  	$	[	*] 
	 7. Goods in the office workshop
	  	$	[	*] 
		  	  
	  
	 
		  	$	[	*] 
		
	 Third Party Liability Insurance
	  	Insurance Amount	 
	 Person and property damage
	  			
		
	 Highest compensation
	  			
	 - per accident
	  	$	[	*] 
	 - per insurance year
	  	$	[	*] 

  
  

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

 Page 2 
 This insurance is valid according to section C, claim for damages that arise from the insured operation and for damage from delivered product. The insurance is valid in the entire world expect in the US
and Canada. 
 However the insurance is valid around the world during sales- and purchasing travels and also at conferences and conventions.

 With changes to the above the insurance is valid for damages from delivered product also in the US and Canada. 

Export is anticipated as noted below: 
 Annual
turnover in the Nordic countries $[*] 
 Delivery within the Nordic countries 
 Direct export to Europe/USA/Canada is occurs 
 Annual turnover in the USA and/or Canada $[*]

  

					
	 Burglary Insurance
	  	 	 
	 Compensation is paid up to 12 months
	  			
		
	 Legal Protection Insurance
	  	 	 
	 Highest compensation per dispute
	  	 	[*] base amount	  
	 For all disputes during one insurance year
	  	 	[*] base amount	  
		
	 Business Travel Insurance
	  	 	 
	 -
	  			
	 -
	  			
	 -
	  			
		
	 Excess/Waiting Period
	  	 	 
	 Property Insurance
	  	 	[*]% of base amount	  
	 Third Party Liability Insurance
	  	 	[*]% of base amount	  
	 Burglary Insurance
	  	 	[*] waiting period	  
	 Legal Protection Insurance
	  	 
 
 	[*] base amount and
[*]% of costs over
[*] base amount	  
  
  

  
  

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

 Page 3 
  

			
	 Terms of Insurance
	  	 
	 -
	  	
	 -
	  	
	 -
	  	

 Base amount refers to price base amount 
 Price base amount for year 2010 is $[*] 
  

 

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

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