Document:

EX-10.11

 Exhibit 10.11 

***Text Omitted and Filed Separately with the Securities and Exchange Commission 

 
  

 
 DISTRIBUTION AGREEMENT 

DATED AS OF MARCH 1, 2012 

BETWEEN 

AMPIO PHARMACEUTICALS, INC. 

AND 

FBM INDUSTRIA FARMACEUTICA, LTDA. 

 
  

 

 DISTRIBUTION AGREEMENT (this “Agreement”), dated
as of March 1, 2012 (the “Effective Date”), between Ampio Pharmaceuticals, Inc., a Delaware corporation (“Ampio”), and FBM Industria Farmaceutica, Ltda., VP 3D, Qd, 8B, Mod. 9112 CEP 75132-095, Anapolis - GO, Brazil
(“Distributor”). Each of Ampio and Distributor are referred to herein as a “Party” or the “Parties.” 

Introduction 
 Ampio has rights
to market, distribute and sell the Product. Ampio wishes to distribute the Product by appointment of distributors to make sales in certain territories. 

Ampio wishes to appoint Distributor as its exclusive distributor to promote, advertise, market, distribute and sell the Product in Brazil (the
“Territory”) and Distributor wishes to act as distributor on the terms and conditions set forth in this Agreement. 

Capitalized terms shall have the meanings ascribed to such terms in Section 12.2 or as otherwise provided in this Agreement. 

For good and valuable consideration, and in reliance upon the covenants, promises, and representations and warranties contained herein, the
Parties, intending legally to be bound, hereby agree as follows: 
 ARTICLE I 

APPOINTMENT OF DISTRIBUTOR 

Section 1.1 Appointment. 

(a) Subject to the terms and conditions of this Agreement, Ampio hereby appoints Distributor to act as its exclusive distributor to promote,
advertise, market, distribute and sell the Product in the Field in the Territory during the Term. Distributor hereby accepts the appointment and agrees to use commercially reasonable efforts to promote, advertise, market, distribute and sell the
Product in the Field in the Territory during the Term in accordance with the terms and conditions of this Agreement. 
 (b) Subject to
Article 8, Ampio hereby retains all rights outside the Territory and outside the Field with respect to the Product in all respects, including the right to appoint other distributors. 

(c) Ampio shall forward to Distributor all inquiries, requests for information and purchase orders from Persons in the Field in the Territory
relating to the Product. 
 (d) At all times during the Term, Distributor shall obtain, hold and Maintain, at its own cost and expense, all
applicable Brazilian Governmental Authority authorizations to label, package, promote, advertise, market, distribute and sell the Product in the Territory, including, without limitation, licenses, registrations and/or authorizations that are
required from a distributor of pharmaceutical products, probiotics, enzymes, cosmetics and contraceptives. 

 Section 1.2 Exclusivity. The appointment in Section 1.1(a) shall be exclusive to
Distributor in the Field in the Territory during the Term until the Exclusivity Termination Date (if any). During the Term until the Exclusivity Termination Date, Ampio shall not (directly or indirectly) appoint as its distributor any Person to, nor
shall itself, promote, advertise, market, distribute or sell the Product, or any versions thereof, or any competitive Product in the Field in the Territory, nor shall supply any Third Party for promotion, advertisement, marketing, distribution or
sale of the Product, or any versions thereof, or any competitive Product, in the Field in the Territory. 
 Section 1.3 Limitations
on Appointment. Distributor shall not, and, if permitted under applicable Laws, shall cause each of its Sub-Distributors not to, (i) actively promote, advertise, market, distribute or sell the Product outside the Field or outside the
Territory; or (ii) support by its own actions any Third Party in doing any of the foregoing (which support includes, for example and without limitation, providing any written marketing materials, conducting or financing any clinical trials or
otherwise providing any consideration in support of same). In addition, once Distributor learns of any conduct by a Sub-Distributor of these prohibited activities, Distributor shall, if permitted under applicable Laws, use commercially reasonable
efforts to end all such prohibited activities by such Sub-Distributor within a commercially reasonable time period, which in all events shall be within 6 months of first learning of any such prohibited activities by such Sub-Distributor, and if
unable to end all such prohibited activities by such efforts: if permitted under applicable Laws, (a) terminate the appointment of such Sub-Distributor; and (b) stop selling (directly or indirectly through other Sub-Distributors or
otherwise) the Product to such Sub-Distributor. If Ampio notifies Distributor in writing of any conduct by a non-Affiliated Sub-Distributor of any such prohibited activities, Distributor shall thereafter confirm in writing to Ampio that Distributor
has complied with the immediately preceding sentence with respect to such Sub-Distributor. The Parties agree that if Distributor breaches its obligations under this Section 1.3, Ampio shall have the right, in Ampio’s sole discretion, to
either (a) provide written notice to convert Distributor’s appointment pursuant to Section 1.1 from exclusive distributor to non-exclusive distributor and the date of receipt of such notice shall be treated as an Exclusivity
Termination Date; or (b) terminate this Agreement pursuant to Section 10.2. 
 Section 1.4 No Compensation. Ampio is
not obligated to pay compensation for Distributor’s performance of its obligations hereunder, and Distributor’s sole compensation shall arise from its resale of the Product. Ampio shall not provide Distributor with any other compensation
or benefits, and Ampio shall not be responsible for reimbursement of any out-of-pocket expenses, except as expressly set forth herein. 

Section 1.5 Relationship. In the exercise of their respective rights and the performance of their respective obligations
hereunder, the Parties are and shall remain independent contractors. Nothing in this Agreement shall be construed: 

  
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 (a) to give either Party the right or power to direct or control the daily activities of the
other Party; 
 (b) to create the relationship between the Parties of principal and agent, franchiser and franchisee, partners, joint
ventures, co-owners or otherwise as participants in a joint undertaking; 
 (c) to authorize either Party to bind the other Party to, or
assume or create any contract and obligation of any kind, express or implied, on behalf of the other Party or to any other Person; or 
 (d)
to waive any right, interest and claim that one of the Parties may have against any other Person. 
 ARTICLE II 

MARKETING AND PROMOTION 

Section 2.1 Steering Committee. 

(a) The Parties shall appoint a committee (the “Steering Committee”) comprised of one member designated by Ampio and one
member designated by Distributor. The initial members of the Steering Committee shall be Bruce Miller, Zertane Product Manager, for Ampio and Dr. Alexandre Feliciano Ferreira, for Distributor. Each Party may replace its Steering Committee
member at any time upon written notice to the other Party. 
 (b) The Steering Committee shall meet at least on a calendar quarterly basis,
which meeting can be a teleconference, and shall be responsible for reviewing and steering the promotion, advertising and marketing activities relating to the Product and the performance of the Agreement by the Parties. 

(c) Each Party may invite, with the approval of the other Party (which shall not be unreasonably withheld), additional individuals to attend
one or more meetings of the Steering Committee as ad hoc guests. 
 Section 2.2 Promotion, Advertising and Marketing. 

(a) During the Term, Distributor shall actively promote, advertise, market, distribute and sell the Product only in the Field and only in the
Territory. 
 (b) Distributor shall commercialize the Product in accordance with the Business Plans attached as Exhibit A and such additional
Business Plans to be developed by Distributor during the Term of this Agreement. Distributor shall update the Business Plans at least annually and present them to Ampio for review no later than October 1 of each year preceding the
implementation of such plan. Such Business Plan shall include, at a minimum: (i) Distributor’s proposed promotion, advertising and marketing efforts; and (ii) a list of planned promotional activities, such as training sessions for the
education and training of Customers. 

  
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 (c) Distributor shall produce promotion, advertising and marketing materials for the Product in
the Territory. In connection therewith, Distributor shall conduct such activities, including development, translation, printing and communication of marketing, sales, medical education or other related materials (e.g., sales literature, advertising
materials and promotional programs) as commercially necessary for the distribution and sale of the Product in the Territory (along with all other documents and other materials intended for public distribution created by or on behalf of Distributor
or any Sub-Distributor regarding Ampio or any Product, collectively, “Distributor Materials”). Ampio shall provide such support (e.g., regarding technical information relating to the Product or printed materials such as product
labels) as is reasonably necessary to permit Distributor to fulfill any relevant regulatory requirements with regard to the Distributor Materials. Distributor shall bear its own costs associated with Distributor Materials, and shall provide all
Distributor Materials that would entail public communication regarding the Product to Ampio (translated in English, if applicable) for its prior review and prompt approval insofar as the material relates to the Product, which approval shall not be
unreasonably withheld, provided that any accurate translation of any such materials previously approved by Ampio, or any materials provided by Ampio, shall not require Ampio’s separate approval. Unless Ampio has notified Distributor of
any objections within 10 Business Days after receipt of such Distributor Materials, Ampio shall be deemed to have approved the Distributor Materials. 

Section 2.3 Sub-Distributors. Distributor shall be entitled to appoint one or more Sub-Distributors to promote, advertise, market,
distribute or sell the Product in the Territory in accordance with the terms and conditions of this Agreement; provided, however, that Distributor shall not utilize or engage any Competitor of Ampio as a Sub-Distributor, without the prior
written consent of Ampio. Distributor shall remain jointly and severally liable under this Agreement for the actions and omissions of each of its Sub-Distributors, and Distributor shall be solely responsible for any commitments, obligations or
liabilities made by any of its Sub-Distributors. Distributor hereby acknowledges that the appointment of any such Sub-Distributor does not reduce, impair or negatively affect its ability to perform each one of its obligations hereunder. 

Section 2.4 Customer Information. 

(a) Within 20 days of the end of each Calendar Quarter during the Term, Distributor shall provide Ampio with a quarterly report, which shall
include the following information: (i) the number of new Customers added in the Calendar Quarter ; (ii) the number of unit sales of each Product ; (iii) the average price paid by each Customer for each Product ; (iv) any
information required by Law, such as Customer complaint information; and (v) any such other information that may be reasonably requested by Ampio. 

Section 2.5 Rights and Obligations of Distributor. Consistent with applicable Laws, Distributor shall actively promote the sale
and distribution of the Product in the Territory. Without limiting any other obligation of Distributor hereunder, in particular, Distributor shall: 

(a) appoint and train appropriately qualified staff to carry out its duties under this Agreement; 

(b) undertake debtor collection; 

  
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 (c) check product availability and confirm delivery dates to Customers; 

(d) take orders from Customers and place such orders with Ampio; 

(e) track Customers’ orders and respond to Customers’ inquiries on orders; 

(f) undertake key account management; 

(g) provide other customer service activities as requested by Ampio and agreed to by Distributor; 

(h) assume no obligation or liability in Ampio’s name; 

(i) refrain from acting in such a manner as to be construed an employee or agent of Ampio; 

(j) make no representations or claims with respect to the Product, except in accordance with Section 3.1; 

(k) maintain sufficient inventory to fulfill its obligations under this Agreement and to Customers; 

(l) keep Ampio informed on a reasonably regular basis on sales activity, and promptly disclose to Ampio all material information relating to
the Product obtained concerning purchasing plans of existing and prospective Customers; 
 (m) within 30 days of expiration or termination of
this Agreement, return to Ampio, at Ampio’s expense, all samples, catalogs, literature, correspondence, sales records, market data or information and other similar documents or materials on hand relating to the Product; 

(n) submit marketing materials relating to the Product to the Brazilian Governmental Authorities, whenever required or necessary by applicable
Law, or as directed by Ampio or any Governmental Authority in the Territory, and provide reasonable assistance to Ampio in connection with Ampio’s submission of marketing materials relating to the Product in any country or jurisdiction in which
Ampio is required by Laws to make such submissions; 
 (o) maintain facilities, including warehousing and distribution facilities, in the
Territory suitable for the conduct of Distributor’s business and in compliance with all applicable legal requirements; and 
 (p)
obtain, hold and Maintain all Product Registrations. 
 Distributor may agree to provide other incidental services and perform other administrative
functions in connection with or incidental to its duties hereunder, consistent with applicable Laws. 

  
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 Section 2.6 Competing Product. During the Term, Distributor shall not, and, if
permitted under applicable Laws, shall cause its Sub-Distributors not to, directly or indirectly engage in the manufacture, sale, offer for sale, marketing, promotion, distribution, solicitation of order or service of any competitive product in the
Territory other than the Product as provided in this Agreement. In addition, once Distributor learns of any conduct by a Sub-Distributor of such activities, Distributor shall, unless such activities have been approved by Ampio and unless prohibited
by applicable Laws, use commercially reasonable efforts to promptly end all such activities by such Sub-Distributor within a commercially reasonable time period, which in all events shall be within 6 months of first learning of any such prohibited
activities by such Sub-Distributor, and if unable to end all such prohibited activities by such efforts: if permitted under applicable Laws (a) terminate the appointment of such Sub-Distributor; and (b) stop selling (directly or indirectly
through other Sub-Distributors or otherwise) the Product to such Sub-Distributor. If Ampio notifies Distributor in writing of any conduct by a non-Affiliated Sub-Distributor of any such prohibited activities, Distributor shall thereafter confirm in
writing to Ampio that Distributor has complied with the immediately preceding sentence with respect to such Sub-Distributor. The Parties agree that if Distributor breaches its obligations under this Section 2.6, Ampio shall have the right, in
Ampio’s sole discretion, to either (a) provide written notice to convert Distributor’s appointment pursuant to Section 1.1 from exclusive distributor to non-exclusive distributor the date of receipt of such notice shall be
treated as an Exclusivity Termination Date; or (b) terminate this Agreement pursuant to Section 10.2. 
 ARTICLE III 

DISTRIBUTION OF PRODUCT 

Section 3.1 Distributor Covenants. Distributor hereby covenants and agrees for the benefit of Ampio that Distributor shall: 

(a) conduct any promotion, advertising, marketing, distribution or sale of the Product in accordance with all applicable Laws and in material
conformance with applicable industry codes, guidelines and standards, including each as amended and in force from time to time, and shall cultivate good relationships with Customers and potential customers in the Territory in accordance with sound
commercial principles; 
 (b) observe and comply with such storage, stock control and operational practices and procedures with respect to
the Product as may be legally required and as Ampio may specify or approve from time to time; 
 (c) not make any representation to Customers
nor give any warranties other than those printed on the Product’ packaging or labeling or included within marketing or sales aid material or other Product information provided or agreed to by Ampio; 

(d) during the Term of this Agreement and for 3 years following expiration or termination of this Agreement, or such longer period as may be
required by applicable Laws, maintain complete and accurate books of account and records showing orders placed, sales and services stock with respect to the Product; 

(e) not use the services of any Person debarred or suspended under section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or
under the Brazilian ANVISA regulation, in performing its obligations or exercising its rights under this Agreement. Distributor shall promptly notify Ampio if any Person whose services Distributor is using in the performance of its obligations or
exercise of its rights under this Agreement becomes debarred or suspended; 

  
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 (f) submit marketing materials relating to the Product, if any, to local Governmental Authorities
in the Territory where such submissions are required or necessary or as directed by Ampio or any Governmental Authority; 
 (g) be
responsible for all reimbursement activity relating to the Product; 
 (h) promote, advertise, market, distribute and sell the Product in the
Territory in substantially the same manner as other of Distributor’s businesses; and 
 (i) execute trade terms, quantity discount,
settlement terms, etc. in substantially the same manner as other of Distributor’s businesses. 
 Section 3.2 Branding.
Distributor shall have the right to choose the trademarks, logos and/or trade dress (the “Product Branding”) pursuant to which the Product are marketed and sold in the Territory, provided, however, that Ampio’s
“Zertane” trademark shall be included in the Product Branding in a manner to be mutually agreed upon by the Steering Committee. 

Section 3.3 Insurance. The Parties shall maintain adequate insurance, in such amounts and with such insurance companies as is
customary in accordance with sound business practices consistent with the nature of the Product. Each Party shall upon the request of the other Party furnish certificates of such insurance. 

ARTICLE IV 

PURCHASE, SALE AND DELIVERY OF PRODUCT 

Section 4.1 Supply of Product. 

(a) Ampio shall use commercially reasonable efforts to manufacture and supply the Product with the Product Branding for Distributor during the
Term with such quantities of the Product as Distributor shall order from Ampio on the terms and conditions set forth in this Agreement. 

(b) Ampio shall have the right to satisfy its supply obligations under this Agreement either in whole or in part through arrangements with
Affiliates or Third Parties engaged by Ampio, provided that Ampio remains solely liable for the performance of such obligations. 

(c) Ampio shall notify Distributor as soon as commercially reasonable, taking due account of Distributor’s need to be informed, in the
event Ampio anticipates any problems with supplying the quantities of the Product set forth in any forecast provided pursuant to Section 4.3, and the Parties shall agree on appropriate measures to address any such problems. 

Section 4.2 Forecasts. Upon execution of this Agreement, and for each Calendar Quarter thereafter, Distributor shall provide to
Ampio, fifteen (15) days before the start of each Calendar Quarter a written forecast of its best estimate Order forecast for the 12-month period 

  
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beginning with the start of the next Calendar Quarter, such forecast to be broken down Product-by-Product and month-by-month. Except as provided in Section 4.5(c), the forecasted amounts for
the first 4 quarters of the forecast shall be deemed a binding and firm purchase order. 
 Section 4.3 Orders. 

(a) All orders from Distributor to Ampio shall be initiated by a written purchase order specifying the quantities of the Product and requested
dates of shipment (each, an “Order”) and shall be deemed accepted within 5 Calendar Days after receipt by Ampio, unless Ampio notifies Distributor in writing within those 5 Calendar Days. 

(b) Ampio shall not refuse to accept an Order which falls within the committed forecasts. 

Section 4.4 Order of Precedence. Any inconsistency in any documents relating to the purchase of the Product shall be resolved by
giving precedence in the following order: (i) the terms and conditions of this Agreement (including the Exhibits attached hereto); (ii) the provisions and text appearing on the face of the applicable Order insofar as they refer to the
specific Order; and (iii) other documents, exhibits and attachments which accompany such Order. 
 Section 4.5 Taxes and
Governmental Charges. Prices do not include any taxes or other governmental charges, including import or export duties, value-added, sales, use or privileges taxes, property or excise, or similar taxes levied by any government. Distributor shall
pay all such taxes or charges on or before the due date. 
 Section 4.6 Shipment, Delivery and Title. Ampio shall deliver the
Product EXW (Incoterms 2000) at a facility designated by Ampio in Europe on the date as specified in the Order, provided, that such dates specified in the Orders shall allow for a delivery time of at least thirty (30) days from date of Order.
The product shall be delivered as bulk tablets and with Distributor responsible for labeling and packaging in final trade dress suitable for distribution to final users. Title to each of the Product shall pass to Distributor when delivery is made to
the carrier at such point of shipment. Ampio shall be entitled to change the point of shipment, provided, however, that Ampio shall be responsible for any additional costs or expenses incurred by Distributor in connection with such changed point of
shipment. 
 Section 4.7 Rejection of Delivery. 

(a) Within 30 days of delivery of the Product to Distributor, Distributor shall notify Ampio in writing of any physical damage or issue which
is apparent from an external review of the packaged Product, and within 15 days of Distributor’s receipt of notice from a Customer that any Product has a defect and/or does not conform to the Specifications for the Product, Distributor shall
notify Ampio in writing of such claims by the Customer. In each case, Distributor shall, if possible, include with its notice sufficient samples to permit Ampio to evaluate Distributor’s or the Customer’s claims. 

  
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 (b) Within 30 days of receipt of those samples, Ampio will inform Distributor in writing whether
it accepts or rejects Distributor’s or the Customer’s claims. If the claim is accepted, then Ampio shall use its commercially reasonable efforts to replace the Product free of charge DDP (Incoterms 2010) destination as indicated by
Distributor in writing or, at Distributor’s discretion, credit Distributor the amount actually paid by Distributor for such Product including transport and any taxes or other governmental charges. Distributor shall return all non-conforming
Product (less reasonable samples) in its possession at Ampio’s expense within 30 days of the date of Ampio’s written confirmation that it accepts the claim, provided that such shipment can be made in accordance with applicable Laws,
including export Laws. 
 (c) If Ampio does not accept the claim, the Parties shall submit samples of the non-conforming Product for testing
to an independent expert agreed upon by both Parties acting reasonably. If the Parties are unable to agree on the identity of the expert, the Parties shall jointly apply to a mutually agreed Third Party for the appointment of an expert. The
expert’s determination will be final absent of manifest error. The costs associated with such expert determination shall be borne by the losing Party. 

Section 4.8 Terms of Payment. Ampio shall issue invoices for each shipment upon delivery in accordance with Section 4.6.
Terms of payment shall be net thirty (30) days from date of the invoice. All payments shall be in United States Dollars and shall be fully net, without set-off, deduction or counterclaim. 

Section 4.9 Payment and Pricing. Distributor shall pay to Ampio for Product supplied hereunder as follows: 

Within thirty (30) days after supply by Ampio to Distributor, its Affiliates or its Subdistributors of any Product, Distributor shall pay
to Ampio an amount equal to Transfer Price. “Transfer Price” means US$[...***...] per tablet, subject to annual adjustment on each anniversary of the date of first commercial sale of the Product in the Territory; provided that from
and after the date upon which Distributor has bought and paid for [...***...] pills, the Transfer Price shall be reduced by US$[...***...] per tablet. 

Section 4.10 Withholding Tax. (a) All payments by Distributor hereunder shall be made without any deduction and free and
clear of and without deduction for or on account of any withholding tax or similar tax deduction (the “Withholding Taxes”) , except to the extent that Distributor is required by law to make payment subject to such Withholding Taxes.
If any amounts in respect of Withholding Tax must be deducted, or any other deductions for or on account of Withholding Tax must be made, from any amounts payable or paid by Distributor hereunder, Distributor shall pay such additional amounts as may
be necessary to ensure that Ampio receives a net amount equal to the full amount which it would have received had payment not been made subject to deduction of such Withholding Tax. 

(b) Without affecting item (a) above, if Ampio is required to make any payment on account of Withholding Tax on or in relation to any
amount received or receivable hereunder or any liability in respect of such payment is asserted, imposed, levied or assessed against Ampio, Distributor shall, on demand by Ampio, indemnify and hold harmless Ampio against that payment or liability.

  
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 (c) Distributor shall maintain official receipts related to any Withholding Taxes and forward copies of such
receipts to Ampio, as instructed by Ampio. 
 Section 4.11 Marketing Expenditures. For three years following the first
commercial sale of the Product in the Territory, Distributor shall invest and spend at least $1,000,000 in Marketing Expenses on the Product in the Territory. Distributor shall draft a “Sales and Marketing Expenditure Plan” to be submitted
to Ampio for its review and comment not later than three (3) months prior to the planned commercial launch of the Product in the Territory. Thereafter, Distributor shall prepare annual updates to the Sales and Marketing Expenditure Plan for
each calendar year before September 15 of the prior year. Each draft of the Sales and Marketing Expenditure Plans shall be reviewed by the Steering Committee, and Distributor shall in good faith take into account any comments from the Steering
Committee in connection with the finalization of each Sales and Marketing Expenditure Plan. Following the receipt of comments, if any, from the Steering Committee, Distributor shall finalize the Sales and Marketing Expenditure Plan with the terms
and expenditures, including (i) a budget for aggregate annual sales and marketing expenditures (the “Budget”) and (ii) the targeted number of sales calls to physicians, determined appropriate by Distributor in its sole
discretion (“Target Sales Calls”). Distributor shall submit each such final Sales and Marketing Expenditure Plan to the Steering Committee for its official records retention (which, in the case of annual updates, shall be submitted
not later than November 15 of the prior year); provided, however that Distributor may amend and revise any such final Sales and Marketing Expenditure Plan to reflect any material change in condition not reasonably within the control of
Distributor (including, but not limited to, Product safety issues, recalls, changes in regulatory requirements, interruption of supply and backorders). Upon written request from Ampio, Distributor shall affirm to Ampio its compliance with the
foregoing minimum marketing expenditures and sales calls. If, however, Distributor fails to spend the minimum Budget amount or conduct such minimum Target Sales Calls, and Distributor further fails to cure such deficiencies within the first six
(6) months of the following period, Ampio may elect to convert the appointment in Section 1.1. of this Agreement to non-exclusive in the Territory by providing written notice to Distributor. 

Section 4.12 Late Charges. If Distributor fails to pay the price or any other payment due to Ampio promptly and when due, Ampio
may recover, in addition to the price or payment, interest thereon at a rate of one percent (1%) per month. 
 Section 4.13
Trade Price. Distributor shall set the trade prices in consultation with the Steering Committee. 
 ARTICLE V 

COMPLIANCE WITH LAWS; REGULATORY MATTERS; RECYCLING

 Section 5.1 Export and Trade Regulations. Both Parties shall endeavor to at all times carry out the transactions contemplated
by this Agreement in conformity with all applicable Laws (including the United States Export Administration Acts), and shall obtain all necessary 

  
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permits and licenses required in connection with the purchase, installation, sale, shipment, service or use of the Product. Shipments by Ampio are or may be subject to restrictions and
limitations imposed by United States export controls and other trade sanctions. Each Party shall at all times use commercially reasonable efforts to keep the other Party informed of, and both Parties shall at all times use commercially reasonable
efforts to comply with, such sanctions, controls and regulations, as well as the United States Foreign Corrupt Practices Act, in its respective use and disposition of the Product. If Ampio learns, or has reasonable cause to believe, or if any branch
or agency of the government of the United States claims that a violation of any applicable export regulation or other trade sanction, export control or trade regulation by Distributor has occurred or is likely to occur because of any shipment by
Ampio to Distributor, Ampio shall promptly notify Distributor and may, in addition to any other remedy it may have, suspend all shipments to Distributor until Ampio is satisfied that such violation did not occur or has ceased to occur, or such claim
is withdrawn or otherwise resolved in favor of Ampio. 
 Section 5.2 Customer Complaints and Product Safety. The Parties will
cooperate in and each Party is responsible for full compliance with its requirements regarding Vigilance, Product complaint, Field Safety Notices, Product Recall requirements. Distributor shall promptly notify Ampio of any customer complaints
of which it may become aware in relation to the Product or any component thereof. Distributor will provide such Product to Ampio for evaluation. Ampio will perform evaluations of such customer complaints and supply the results of such evaluations to
Distributor, including, but not limited to, corrective action(s) and investigations. Distributor will respond directly to the Customer regarding the results of these evaluations. Ampio will be responsible for creating and implementing any corrective
or preventive action that concerns the Product, and shall bear all cost relating to such corrective or preventive action, including all reasonable direct cost and expenses incurred by Distributor. 

Section 5.3 Pharmacovigilance. Under overall Ampio oversight, Distributor shall at its own cost and expense, carry out
pharmacovigilance procedures by means of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of the Product with a view to identifying new information about hazards
associated with Product and preventing harm resulting from Product. 
 Section 5.4 Recalls. In the event any component of the
Product is subject to a recall or withdrawal or other field correction of Product in the Territory, the Parties will cooperate, under overall Ampio oversight, to manage the process in a commercially reasonable manner. In the event of a recall or
potential recall or withdrawal or other field correction of any component of the Product, Ampio will notify and consult with Distributor with regard to the measures to be taken consistent with good business practices. Ampio shall be responsible for
implementing any recall that concerns the Product, and shall bear all cost relating to such recall, including all reasonable direct cost and expenses incurred by Distributor, and Ampio will provide all replacement Product to Distributor or to
Customers free of charge DDP (Incoterms 2010) destination as indicated by Distributor in writing. 

  
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 Section 5.4 Regulatory Interface. Distributor shall be responsible for obtaining
Registration of the Product in the Territory and shall exercise commercially reasonable efforts to obtain and Maintain any Product Registrations in the Territory during the Term. As between the Parties hereto, it is agreed that the Product
Registrations shall be held in the name of Distributor, who shall be the beneficial owner of all Product Registrations and Ampio may not use the Product Registrations, or any of them, on or in respect of any product other than the Product or use any
authorization other than one or more of the Product Registrations on or in respect of the Product, except as may be approved in writing by Distributor. Ampio agrees to use its commercially reasonable efforts to assist Distributor, at
Distributor’s costs, in obtaining and Maintaining the Product Registrations. All costs to obtain or Maintain the Product Registrations shall be borne by Distributor. If any Governmental Authority gives notice to Distributor that its Product
Registration may be invalid or may be revoked, limited, or conditioned, Distributor shall promptly inform Ampio, but in any case not more than 5 Business Days following Distributor’s receipt of such notice. In support of Distributor’s
Registration of the Product, Ampio will (a) shall supply to Distributor efficacy, quality and safety data as specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH), (b) perform or cause to be performed and will supply to Distributor data from Zone 4 stability testing of the Product, and (c) will provide suitable evidence that the site at which the Product is manufactured complies with the
Agency requirements (ANVISA), including, if required, inspection by the Brazilian Regulatory Authorities at manufacturing site. 

Section 5.5 Failure to Maintain. At any time during the Term, if Distributor fails to Maintain an existing Product Registration or
any of the Product Registrations becomes invalid or not in full force and effect with the appropriate authorities in the Territory, then Ampio may either assume, to the extent permitted by applicable law, Distributor’s responsibilities under
this Article V at Distributor’s costs or terminate this Agreement with regard to such Product with immediate effect. 

Section 5.6 Regulatory Requirements. Distributor shall at all times label, package, promote, advertise, market distribute and sell
the Product in accordance with all applicable Laws. Distributor shall also follow all relevant current written regulatory, quality assurance instructions and guidelines agreed by the Parties. 

Section 5.7 Labeling. Subject to Section 3.2 hereof, all labeling and package inserts used in any way in connection with the
Product shall comply with the Product labeling supplied or approved in writing by Ampio and with all applicable Laws. Distributor shall comply with any local legal requirements affecting the labeling and package inserts of the Product. 

Section 5.8 Local Laws. Distributor shall keep Ampio informed of any Laws (including new published Laws or regulations as well as
bills) of the Territory which might be applicable to, or affect the use or sale of, the Product in the Territory. Distributor shall inform Ampio of any instructions or requests inconsistent with these Laws, provided, however, that
Ampio remains independently obligated to be aware of regulatory requirements in all jurisdictions where it has obtained and Maintains a Product Registration. 

  
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 ARTICLE VI 

INTELLECTUAL PROPERTY RIGHTS 

Section 6.1 Grant of License; Ownership of Intellectual Property Rights. Ampio hereby grants Distributor a non-exclusive,
royalty-free, limited license during the Term and under the Intellectual Property Rights of Ampio relating to the Product solely to purchase Product from Ampio and to promote, advertise, market, distribute and sell Product to Customers in the
Territory in accordance with the terms and conditions of this Agreement. Distributor hereby grants Ampio a non-exclusive, royalty-free, limited license during the Term and under the Intellectual Property Rights of Distributor to use the Product
Branding solely for the purposes of this Agreement and for no other purpose whatsoever. 
 Section 6.2 Use of Intellectual Property
Rights. Distributor shall not alter, deface, remove, cover, mutilate, or add to, in any manner whatsoever, any patent notice, copyright notice, trademark, trade name, serial number, model number or legend that Ampio may attach or affix to the
Product. Distributor also agrees that during the Term, it will not otherwise register or use any of Ampio’s Intellectual Property Rights or any word, symbol or design confusingly similar thereto, unless agreed by Ampio. 

Section 6.3 Assistance. Distributor shall, at the expense of Ampio, take such steps as Ampio may reasonably require to assist
Ampio in maintaining the validity and enforceability of the Intellectual Property Rights of Ampio, and Distributor will not do, or allow or authorize any Person to do, any act which could invalidate or be inconsistent with the Intellectual Property
Rights of Ampio and shall not omit, or allow or authorize any Person to omit, to do any act which, by its omission, could invalidate or be inconsistent with the Intellectual Property Rights. 

Section 6.4 Notice of Claims of Infringement. Distributor shall promptly notify Ampio of (a) any claims or objections that
its use of the Intellectual Property Rights in connection with the promotion, advertising, marketing, distribution or sale of the Product may or will infringe the copyrights, patents, trademarks or other proprietary rights of another Person, and
(b) any and all infringements, imitations, illegal use, or misuse, by any Person, of the Intellectual Property Rights of Ampio which come to its attention; provided, however, that Distributor will not take any legal action
relating to the protection of any Intellectual Property Rights of Ampio without the prior written approval of Ampio; and provided further, that Distributor shall render Ampio, at Ampio’s expense, all reasonable assistance in connection
with any matter pertaining to the protection of the Intellectual Property Rights, whether in courts, administrative agencies, or otherwise. 

Section 6.5 Notice of Infringement. Distributor shall promptly notify Ampio of any infringement, violation, claim or objection in
the Territory of or relating to the Intellectual Property Rights or Confidential Information (including trademarks, patents, know-how, etc.) of Ampio which come to Distributor’s attention, and shall, at the expense of Ampio, cooperate in taking
such action as Ampio may reasonably deem necessary in connection with any such infringement, violation, claim or objection. 

  
 13 

 Section 6.6 Reservation of Rights. Except as otherwise expressly set forth herein,
either Party reserves all right, title and interest in the Intellectual Property Rights of it or any of its Affiliates, and the other Party shall not acquire, or be deemed to have acquired, any right, title or interest whatsoever as a result of this
Agreement in the Intellectual Property Rights of either Party or any of its Affiliates. Subject to Section 11.3, upon expiration or termination of this Agreement for any reason, the Parties agree to immediately discontinue any further use of
the Intellectual Property Rights of the other Party granted under this Agreement. 
 ARTICLE VII 

CONFIDENTIALITY 

Section 7.1 Non-Disclosure Obligations. During the Term, a Party may, at its sole discretion, disclose certain Confidential
Information to the other Party. This information will be used solely to permit the receiving Party to exercise its rights and perform its obligations under this Agreement. The receiving Party shall not disclose any Confidential Information to a
Third Party and shall refrain from using or exploiting any and all Confidential Information for any purpose or activities other than those specifically authorized in this Agreement. The receiving Party shall keep such Confidential Information secret
during the Term of this Agreement and for 10 years after the expiration or termination hereof. For clarity, the terms of this Agreement shall be deemed the confidential information of Ampio. 

Section 7.2 Ownership of Material. Except as otherwise expressly provided for herein, all files, lists, records, documents,
drawings and specifications which incorporate or refer to all or a portion of the Confidential Information shall remain the sole property of the disclosing Party. Such materials shall be promptly returned upon the earlier of (a) the disclosing
Party’s reasonable request, or (b) expiration or termination of this Agreement. 
 Section 7.3 Exceptions. The
provisions of this Article VII shall not apply, or shall cease to apply, to data and information supplied by a Party if such data or information (a) was already known to the receiving Party, (b) becomes part of the public domain without a
breach of confidence by the receiving Party or any other Person, (c) was received by the receiving Party from a Third Party without restrictions on such Third Party’s use in favor of the disclosing Party, or (d) was required to be
disclosed pursuant to any statutory or regulatory provision or court order (in which case only such portion of Confidential Information shall be disclosed as is required, and the provisions of this Article VII shall not apply for disclosure in
accordance with the respective statutory or regulatory provision or court order only), provided that the receiving Party shall have the burden of establishing any of the foregoing exceptions. 

ARTICLE VIII 

REPRESENTATIONS, WARRANTIES AND LIABILITIES  

Section 8.1 By Ampio. Ampio represents and warrants to Distributor that (i) Ampio has the full right and authority to enter
into this Agreement and grant the rights granted herein; (ii) Ampio has not previously granted and will not grant any right in conflict with any of the rights granted herein; and (iii) to Ampio’s knowledge on the Effective Date, there
is no existing or threatened action, suit or claim pending against it with respect to its right to enter into and perform any of its obligations under this Agreement. 

  
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 Section 8.2 By Distributor. Distributor represents and warrants to Ampio that
(i) Distributor has the full right and authority to enter into this Agreement and grant the rights granted herein; (ii) Distributor has not previously granted and will not grant any right in conflict with any of the rights granted herein;
and (iii) to Distributor’s knowledge on the Effective Date, there is no existing or threatened action, suit or claim pending against it with respect to its right to enter into and perform its obligations under this Agreement. 

Section 8.3 Product Warranty and Remedies. 

(a) Subject to Section 8.3(b), Ampio hereby warrants that the Product shall be free from material defects in material and workmanship
under normal use and maintenance as provided in the applicable instructions and fulfills the Specifications, for a period of 12 months from the date of shipment of the Product. 

(b) Distributor shall maintain inventory of Product on a first in, first out (FIFO) basis. For Product with expiration date, Distributor shall
distribute such Product by lowest expiration date first. 
 (c) Subject to Section 4.9, the obligation of Ampio under the warranties set
forth in this Section 8.3 is limited to replacement or credit of Product that prove defective. The foregoing notwithstanding, Ampio shall not be responsible for damage to any Product resulting from misuse, negligence or accident by any Person
other than Ampio. 
 Section 8.4 No Implied Warranties. THE EXPRESS REPRESENTATIONS AND WARRANTIES GIVEN IN THIS AGREEMENT ARE
THE ONLY REPRESENTATIONS OR WARRANTIES GIVEN BY AMPIO WITH RESPECT TO THE PRODUCT AND ARE GIVEN IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THOSE OF NONINFRINGEMENT, TITLE, MERCHANTABILITY, COURSE OF DEALING,
USAGE OF TRADE, AND FITNESS FOR A PARTICULAR PURPOSE. DISTRIBUTOR’S EXCLUSIVE REMEDIES AND AMPIO’S SOLE LIABILITY FOR ANY NONCONFORMITY OR DEFECT IN ANY PRODUCT SHALL BE THOSE EXPRESSED IN THIS AGREEMENT. 

Section 8.5 Limitation of Liability. An essential purpose of the limited exclusive liabilities and remedies in this Agreement is
allocation of risk between Ampio and Distributor, which allocation of risks is reflected in the purchase price for the Product. EXCEPT FOR AMPIO’S INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 9 AND/OR AMPIO’S LIABILITY ARISING OUT OF
TERMINATION OF THIS AGREEMENT BY DISTRIBUTOR PURSUANT TO SECTION 10.2, OR AS A RESULT OF A BREACH OF SECTION 7, UNDER NO CIRCUMSTANCES SHALL AMPIO’S LIABILITY ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR AMPIO’S PERFORMANCE OR
ASSERTED FAILURE TO PERFORM HEREUNDER, IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED THE PURCHASE PRICE OF THE PRODUCT OR PART THEREOF TO WHICH SUCH LIABILITY RELATES. EXCEPT 

  
 15 

 
FOR LIABILITY ARISING AS A RESULT OF A PARTY’S INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 9 OR AS A RESULT OF A BREACH OF SECTIONS 6.1 AND/OR 7, IN NO EVENT SHALL EITHER PARTY BE
LIABLE FOR SPECIAL, INCIDENTAL, PUNITIVE, CONSEQUENTIAL, TORT OR ANALOGOUS DAMAGES, INCLUDING DAMAGES RESULTING FROM LOSS OF USE, PROFITS, REVENUES, BUSINESS OR GOODWILL, WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF. 

ARTICLE IX 

INDEMNIFICATION 

Section 9.1 Indemnity.  

(a) Ampio Indemnity. Ampio will indemnify, defend, and hold harmless Distributor, and each of its officers, directors, agents,
employees, representatives, successors, and authorized assigns (collectively, “Distributor Indemnitees”), from and against any and all liabilities, losses, damages, and expenses , including without limitation reasonable
attorney’s fees and expenses (the “Losses”) relating to any demand, claim, suit or proceeding brought by a Third Party to the extent arising from or occurring as a result of: (i) Ampio’s material breach of this
Agreement, (ii) any negligent or willful act or omission by or on behalf of Ampio, (iii) violation of any applicable Law by Ampio, (iv) the actual or alleged infringement of a claim of a patent or the actual or alleged infringement or
misappropriation of a Third Party Intellectual Property Right by the Product, (v) physical injury (including death) and/or property damage actually or allegedly caused by the Product, or (vi) any other representation, act or omission by or
on behalf of Ampio, including Ampio’s performance of or failure to perform any term or condition of this Agreement. Ampio shall not be liable for any Losses resulting from the negligent or willful misconduct of any Distributor Indemnitee. 

(b) Distributor Indemnity. Ampio shall not be liable for any Losses to the extent incurred by Distributor or any other person or entity,
and Distributor shall indemnify, defend, and hold harmless Ampio and its Affiliates and their officers, directors, agents, employees, representatives, successors, and authorized assigns (collectively, “Ampio Indemnitees”) from and
against any and all Losses relating to any demand, claim, suit or proceeding brought by a Third Party to the extent arising from or occurring as a result of (i) Distributor’s material breach of this Agreement, (ii) any negligent or
willful act or omission by or on behalf of Distributor; (iii) violation of any applicable Law by Distributor, (iv) the labeling, packaging, use, offer for sale, sale or distribution of any Product, (v) any modification made to the
Product without Ampio’s prior written consent including physical injury (including death) and/or property damage actually or allegedly caused by it, (vi) any termination or expiration of any Sub-Distributor (to the extent not attributable
to any direct relationship, including any relationship preceding this Agreement, entered into between Ampio and such Sub-Distributor independently from this Agreement), or (vii) any other representation, act or omission by or on behalf of
Distributor, including Distributor’s performance of or failure to perform any term or condition of this Agreement. Distributor shall not be liable for any Losses resulting from the negligent or willful misconduct of any Ampio Indemnitee. 

  
 16 

 Section 9.2 Indemnification Procedure.  

(a) A Party that intends to claim indemnification under this Section 9 shall promptly notify the indemnifying Party of any such claims in
respect of which such Party intends to claim such indemnification, and if applicable such indemnifying Party shall assume the defense thereof with counsel mutually satisfactory to the Parties; provided that such Party shall have the right to
retain its own counsel and, in case compensation for fees and expenses are not otherwise awarded, compensation for such reasonable costs shall be paid by such indemnifying Party provided such indemnifying Party is responsible for the defense
thereof, if representation of such Party by the counsel retained by such indemnifying Party would be inappropriate due to actual or potential conflicting interests between such Party and any other Party represented by such counsel. The
indemnification provided for by this Section 9 shall not apply to amounts paid in settlement of any such claim if such settlement is effected without the consent of the indemnifying Party, which consent shall not be unreasonably withheld. The
failure to deliver notice to the indemnifying Party within a reasonable time after the commencement of any such action, if materially prejudicial to its ability to defend such action, shall relieve the indemnifying Party of any liability to the
other Party under this Section 9.3 to the extent so prejudiced, but the omission so to deliver notice to such indemnifying Party shall not otherwise relieve it of any liability that it may have to such other Party. The indemnified Party shall
cooperate fully with the other Party in the investigation of any such claim covered by this indemnification. 
 (b) If Distributor receives a
demand, claim, suit or proceeding subject to Ampio indemnification under Section 9.1(a)(iv), Distributor shall notify Ampio promptly in writing and give Ampio information, assistance and exclusive authority to evaluate, defend and settle such
claim. Ampio shall then at its own expense and option, (i) settle the claim (which settlement shall include for Distributor the right to sell and use the Product pursuant to this Agreement); (ii) procure for Distributor the right to sell
and use the Product pursuant to this Agreement; (iii) replace or modify the Product to avoid infringement; (iv) defend against such claim; or (v) remove the Product and indemnify and hold harmless Distributor. Should any court of
competent jurisdiction hold in a final decision that the sale, manufacture, or use of such Product constitutes infringement, Ampio shall pay any costs and damages finally awarded against Distributor on the account of such infringement, and if the
use of such Product is enjoined, Ampio shall take one more of the actions under clauses (ii), (iii) or (v) above. Ampio reserves the right, at its sole option, to notify Distributor in writing that as a result of a claim, suit or
proceeding or threat of same in the Territory, Distributor may not market or sell the Product in such Territory, effective as of such written notice, subject to full indemnification of Distributor. The foregoing states the entire and complete
liability of Ampio for any patent infringement or claimed infringement by reason of the sale, manufacture or use of the Product or any part thereof. This Section 9.3(b) shall also apply in the event Ampio receives a claim, suit or proceeding
relating to an actual or alleged infringement of a claim of a patent or an actual or alleged infringement or misappropriation of a Third Party Intellectual Property Right by the Product. 

  
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 ARTICLE X 

TERM AND TERMINATION 

Section 10.1 Term and Renewal The term of this Agreement shall be for a period of twenty (20) years from the date of the
first commercial delivery of Product, unless earlier terminated under the provisions of this Agreement (the “Term”). 

Section 10.2 Termination for Cause. This Agreement may be terminated by Ampio or Distributor in the event of any of the following:

 (a) immediately upon written notice to the other, if the other Party becomes insolvent or seeks protection under any bankruptcy,
receivership, “recuperação judicial/extrajudicial”, trust deed, creditors arrangement, composition or comparable proceeding, or if any such proceeding is instituted against the other Party which proceeding remains
undismissed for a period of 30 days; or 
 (b) in the event that the other Party fails to perform or otherwise materially breaches any of its
obligations hereunder, and does not cure such failure or breach within 60 days of receipt of written notice from the non-breaching Party of such failure or breach. In no event, however, shall such notice of intention to terminate be deemed to waive
any rights to damages or any other remedy which the Party giving notice of breach may have as a consequence of such failure or breach. 

For clarity, the date of any notice of termination for cause under this Section 10.2 shall also be an Exclusivity Termination Date
notwithstanding any wind-down period provided herein. 
 Notwithstanding the foregoing, Ampio shall have the right, in its sole discretion
to in lieu of terminating the Agreement in full pursuant to Section 10.2, convert Distributor’s appointment pursuant to Section 1.1 from exclusive to non-exclusive. 

If Ampio terminates this Agreement pursuant to this Section 10.2 due to Distributor’s breach of Section 2.6 hereof, Ampio shall
have, the right to collect damages equal to the quantity of Product as set forth in the most recent Forecast multiplied by the Transfer Price; further claims are excluded. 

Section 10.3 Termination without Cause. This Agreement may be terminated by Ampio without cause upon one hundred twenty
(120) days written notice. In the event Ampio terminates this Agreement under this Section 10.3, it shall be obligated to pay the following compensation to Distributor: (a) if Termination without Cause occurs prior to the time the
Product is selling in the Territory, Ampio shall pay Distributor an amount equal to five (5) times Distributor’s out-of-pocket expenditures for commercialization of the Product through date of Termination; and (b) if Termination
without Cause occurs after the Product is selling in the Territory, Ampio shall pay Distributor an amount equal to three (3) years’ projected net income to Distributor (the “Projected Income Amount”). The Projected Income Amount
shall be determining utilizing the Distributor’s most recent annual forecast submitted under Section 4.2 hereof, subtracting the Distributor’s costs for the most recent calendar year that are directly related to its distribution of
the Product, and multiplying the result by three. 

  
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 ARTICLE XI 

RIGHTS AND OBLIGATIONS UPON TERMINATION 

Section 11.1 Cessation of Rights. Upon expiration, non-renewal or termination (collectively,
“Termination”) of this Agreement for any reason whatsoever, no Party and none of its directors, officers, stockholders, Sub-Distributor or Affiliates shall have any further obligation to the other Party under this Agreement, except
with respect to Sections 2.5(m), 3.1(d), 4.4., 4.6, 4.7, 4.10, 6.2, 6.6, 8.4, 8.5, 10.2, 10.4, 10.5 and 10.5, Articles 7, 9, 11 and 12 and the definitions in Exhibit I (which shall survive Termination of this Agreement), except that nothing in this
Section 10.5 shall prejudice any rights, claims, or causes of action that may have accrued hereunder or with respect hereto prior to the date of such Termination, including for breach of this Agreement (whether based upon the Termination or
otherwise). 
 Section 11.2 No Penalties; Survival. Without prejudice to any rights or right of action which may have accrued
during the Term, and subject to Sections 10.2, 10.4 and 10.5, neither Party shall be entitled to any compensation or other penalty arising out of Termination, provided this Agreement has expired or been terminated in accordance with its
terms. 
 Section 11.3 Return of Product and Information. Upon Termination of this Agreement, Distributor shall promptly and at
the cost of Ampio return to Ampio or a Third Party designated by Ampio, all Product samples, Confidential Information and all other information supplied by Ampio; provided that in the event that this Agreement terminates as a result of a
material uncured breach by Distributor, Ampio shall not be responsible for such return costs; and provided further, that Distributor may maintain a copy of Ampio’s Confidential Information for as long as reasonably necessary to comply
with applicable Laws. Upon Termination of this Agreement, Ampio may, at its option, elect to purchase any remaining Product from Distributor at cost or allow Distributor to sell its remaining supply of Product in the Territory within reasonable
time. 
 Section 11.4 Obligations of Distributor upon Termination. Upon Termination of this Agreement and subject to
Section 11.3, Distributor shall immediately cease any and all use of the Product Registrations and shall reasonably cooperate in the execution of any documents and the taking of any actions reasonable requested by Ampio to enable Ampio or its
designees to obtain its own Product Registrations upon the cancellation of Product Registrations held by Distributor without interruption or disruption to the distribution, marketing or sales of the Product in the Territory. In addition to the
foregoing, upon any expiration or termination of this Agreement, Distributor shall provide to Ampio or its designees written authorization for Ampio or its designees to market and sell the Product in the Territory under the Product Registration held
by Distributor, until such time as Ampio or its designees obtains all required Regulatory Approvals for the same, at which time Distributor shall cause its Product Registrations to be cancelled. 

  
 19 

 ARTICLE XII 

GENERAL PROVISIONS 

Section 12.1 Notices All notices, requests, claims, demands, waivers and other communications under this Agreement shall be in
writing and shall be by facsimile, courier services or personal delivery to the following addresses, or to such other addresses as shall be designated from time to time by a Party in accordance with this Section 12.1: 

if to Distributor: 
 FBM Industria
Farmaceutica, Ltda. 
 VP 1-B Qd, 8B Mod. 9/21 

75133-600 DAIA, Anapolis – GO, Brazil 

Attention: Moises Alves de Oliveira Neto. 

Attention: Marcelo Reis Perillo 

Facsimile:                      

with a copy (which shall not constitute notice) to: 

FBM Industria Farmaceutica, Ltda. 

VP 1-B Qd, 8B Mod. 9/21 

75133-600 DAIA, Anapolis – GO, Brazil 

Attention: Dr. Alexandre Feliciano Ferreira 

Facsimile:                      

if to Ampio: 
 Ampio
Pharmaceuticals, Inc. 
 5445 DTC Parkway, Suite 925 

Greenwood Village, CO 80111 USA 

Attention: Chief Executive Officer 

Facsimile: +1 720-437-6501 
 with
a copy (which shall not constitute notice) to: 
 Goodwin Procter LLP 

Exchange Place 
 Boston, MA 02109

 Attention: Larry Wittenberg 

Facsimile: 617-523-1231 
 All notices and
communications under this Agreement shall be deemed to have been duly given (x) when delivered by hand, if personally delivered, (y) 1 Business Day after when delivered to a courier, if delivered by commercial one-day overnight courier
service or (z) when sent, if sent by facsimile, with an acknowledgment of sending being produced by the sending facsimile machine. 

  
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 Section 12.2 Definitions. For the purposes of this Agreement, the following terms
have the following meanings: 
 “Active Ingredient” means the chemical compound known as (i) tramadol (base)
(ii) any salt of tramadol; (iii) any metabolites, isomers, enantiomers, polymorphs or pro-drugs of tramadol or of any salt of tramadol and (iv) any compounds obtained by forming or breaking a non-covalent bond with or of any of (i),
(ii) or (iii) if such compounds retain the activity of tramadol. 
 “Affiliate” means, with respect to any
Person, any other Person controlling, controlled by or under direct or indirect common control with such first Person. For purposes of this definition, a Person shall be deemed to control another Person if it owns or controls 50% or more of the
voting equity of the other Person (or other comparable ownership if the Person is not a corporation), or otherwise possesses the power to direct the management or policies of the other Person, whether through ownership of voting securities or by
contract or otherwise; provided that solely for purposes of this Agreement, no Party shall be deemed to be an “Affiliate” of any other Party (or any of its Affiliates). 

“Business Day” means any day other than a Saturday or Sunday or a day on which banking institutions at the domicile of Ampio
or Distributor are permitted or required by Law, executive order or decree of a Governmental Authority to remain closed. 

“Business Plan” means a description of the plan for marketing the Product in the Territory during the Term, including at
least: (1) the projected minimum sales quantities per quarter during the Term; (2) the distribution route (direct or indirect), (3) the projected reimbursement for the Product, (4) and any other information reasonably necessary
for the Parties to assess the commercialization of the Product in the Territory. 
 “Competitor” means any Third Party
which, by itself or through any of its Affiliates, is engaged or otherwise participating in any business or other activity involving the manufacture for commercial sale or distribution of Product that compete with Product. 

“Confidential Information” means all data and information of a confidential or proprietary nature, including know-how and
trade secrets relating to the business, the affairs and the Product of a Party. Confidential Information may be communicated orally, in writing or in any other recorded or tangible form. Data and information shall be considered to be Confidential
Information, (a) if a Party has advised the receiving Party of such confidential nature, or (b) if, due to such character or nature, a reasonable person in a like position and under like circumstances as the receiving Party would treat
such as secret and confidential. 
 “Customer” means a Person who (a) is resident in the Territory; and (b) has
entered into an agreement (oral or written, including purchase orders) for the purchase of Product with Distributor. 

  
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 “Field” means persistent or recurrent ejaculation sooner than desired either
before or shortly after penetration, typically reflecting an IELT (intravaginal ejaculatory latency time) of two minutes or less, over which the sufferer has minimal or no control, or such substantially similar description as may be adopted by the
Governmental Authority in the Territory. 
 “Force Majeure” has the meaning as set forth in Section 12.8. 

“Governmental Authority” means any nation, state, province, county, city or political subdivision and any official, agency,
arbitrator, authority, court, department, commission, board, bureau, instrumentality or other governmental entity of any thereof, whether domestic or foreign. 

“Intellectual Property Rights” means, collectively, all rights in, to and under patents, trade secret rights, copyrights,
mask works, trademarks, service marks, trade dress and similar rights of any type under the laws of any Governmental Authority, including, without limitation, all applications and registrations relating to the foregoing, which either Party may at
any time own, control, license, adopt, use or register with respect to the Product. 
 “Laws” means any law, statute, rule,
regulation, guideline, ordinance or other pronouncement of any Governmental Authority having the effect of law or guidances of any Governmental Authority in the United States and in the Territory, or any province, county, city or other political
sub-division thereof. 
 “Maintain” means that: (a) Distributor shall exercise commercially reasonable efforts to
maintain the Product Registrations as valid and in force with the appropriate Governmental Authorities, (b) Distributor shall use commercially reasonable efforts to the extent possible to minimize the number and extent of any changes to the
Product Registrations, and (c) Distributor shall notify Ampio of any change to any of the Product Registrations during the Term and any such change requested or required by appropriate Governmental Authorities in the Territory. 

“Marketing Expenses” means the specific direct marketing, promotion and advertising costs incurred directly on account of the
Product, including promotional materials, professional education, product-related public relations, relationships with opinion leaders and professional societies, market research, and other similar activities related to the Product. Such costs will
include both internal overhead costs (e.g., salaries, benefits, supplies and materials, etc.) and costs of outside services and expenses (e.g., consultants, agency fees, meeting costs, etc.), in all cases only to the extent directly applicable to
the Product. Notwithstanding anything to the contrary in the foregoing, Marketing Expenses shall specifically exclude the cost of activities that promote a party’s business as a whole without being specific to the Product relating disease
(e.g., corporate image advertising). 
 “Person” means and includes any individual, corporation, trust, estate,
partnership, limited liability company, joint venture company, association, league, governmental bureau or agency, or any other entity regardless of the type or nature thereof. 

“Product Registrations” means existing and future marketing and regulatory authorizations relating to the Product in the
Territory including such authorizations relating to any and all existing and future uses for the Product, necessary for import, labeling, packaging, advertisement, marketing, distribution and sale of the Product. 

  
 22 

 “Product” means an orally disintegrating tablet formulation of the Active
Ingredient that is suitable for use in the Field. 
 “Specifications” shall mean the specifications for the Product that
are included in the User Manual for such Product. 
 “Sub-Distributor” means any Third Party or any Affiliate of
Distributor that has entered into a written agreement with Distributor for the distribution of Product anywhere in the Territory. 

“Third Party” means any Person other than Ampio, Distributor or their respective Affiliates. 

“Zertane” means Ampio’s trademark and/or trade dress for the Product. 

Section 12.3 Descriptive Headings; Certain Interpretations. The table of contents and headings contained in this Agreement are for
reference purposes only and shall not control or affect the meaning or construction of this Agreement. Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “or”
is not exclusive and “include,” “includes” and “including” are not limiting; (b) “hereof,” “hereto,” “hereby,” “herein” and “hereunder” and words of similar import
when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (c) “date hereof” refers to the date of this Agreement; (d) “extent” in the phrase “to the
extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”; (e) definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms;
(f) references to an agreement or instrument mean such agreement or instrument as from time to time amended, modified or supplemented, and all exhibits, appendices, schedules or other attachments thereto; (g) references to a Person are
also to its permitted successors and assigns; (h) references to an “Article,” “Section,” “Clause,” “Exhibit” or “Schedule” refer to an Article, Section or Clause of, or an Exhibit or Schedule
to, this Agreement; (i) words importing the masculine gender include the feminine or neuter and, in each case, vice versa; (j) references to a Law include any amendment or modification to such Law and any rules or regulations issued
thereunder, whether such amendment or modification is made, or issuance of such rules or regulations occurs, before or after the date of this Agreement; and (k) references to monetary amounts shall be denominated in United States Dollars. 

Section 12.4 Waivers. The waiver by either Party of a breach or default in any of the provisions of this Agreement by the other
Party shall not be construed as a waiver of any succeeding breach of the same of either Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder nor operates as a waiver of any breach or default by the
other Party. 

  
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 Section 12.5 Entire Agreement and Amendments. This Agreement constitutes the entire
agreement between the Parties with respect to the subject matter hereof and supersedes all prior agreements between the Parties, whether written or oral, relating to the same subject matter. No modification, amendment or supplements to this
Agreement shall be effective for any purpose unless in writing, signed by each Party. Approvals or consents hereunder of a Party shall also be in writing. 

Section 12.6 Severability. In the event that any provision herein shall be determined to be void or unenforceable in whole or in
part for any reason whatsoever, such unenforceability or invalidity shall not affect the enforceability or validity of the remaining provisions or part thereof contained in this Agreement and such void or unenforceable provisions shall be deemed to
be severable from any other provisions or part thereof herein contained. In the event that any of the provisions herein contained are held to be unreasonable by reason of the duration or type or scope of services covered by the said provision then
the said provision shall be given effect only to the extent as may be enforceable or deemed enforceable by any court of competent jurisdiction. 

Section 12.7 Assignments. Neither Party shall transfer or assign the Agreement or delegate the performance of its
obligations hereunder without the express written consent of the other Party. Notwithstanding the foregoing, either Party may assign this Agreement (a) to any of its Affiliates; or (b) to any Third Party in connection with the sale or
transfer, by merger, reorganization, consolidation or otherwise, of all or substantially all of the Party’s business or assets to which this Agreement relates. This Agreement and the provisions hereof shall be binding upon and inure to the
benefit of the Parties hereto and their respective successors and permitted assigns. 
 Section 12.8 Force Majeure. 

(a) Neither Party shall be liable to the other Party for any delay or omission in the performance of any obligation hereunder, where the delay
or omission is due to any cause or conditions beyond the reasonable control of the Party obligated to perform, including strike or other labor difficulties, acts of God, acts of government, war (declared or undeclared), acts of terrorism, fire,
epidemic of disease, riots, civil commotion, embargoes, government requisition or impoundment or other acts of any Governmental Authority or inability to obtain supplies (“Force Majeure”). For clarification, failure to obtain or
maintain a Product Registration shall not be considered a Force Majeure event. If Force Majeure prevents or delays the performance by a Party of any obligation under this Agreement, then the Party claiming Force Majeure shall notify the other Party
thereof in writing within 15 days of the occurrence of such Force Majeure. 
 (b) If the performance of this Agreement shall be prevented for
a continuous period exceeding six months from the date of notice given pursuant to Section 12.8(a) due to an event of Force Majeure, the Party receiving notice of an event of Force Majeure shall be entitled to terminate this Agreement by giving
written notice to the other. Distributor, if it is the Party receiving notice of an event of Force Majeure (instead of exercising its rights in the preceding sentence) may elect to extend the Term of this Agreement for one additional year. As
regards the supply of Product for the remainder of the Term, absent termination by the Party receiving notice of an event of Force Majeure, this Agreement shall continue in full force and effect in accordance with its terms. 

  
 24 

 Section 12.9 No Third-Party Beneficiaries. This Agreement is for the sole benefit of
the Parties hereto and their permitted successors and assigns and nothing herein express or implied shall give or be construed to give to any Person, other than the Parties hereto and such successors and assigns, any legal or equitable rights or
remedies. 
 Section 12.10 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an
original but all of which shall constitute one and the same instrument. Delivery of an executed counterpart of this Agreement by facsimile or other electronic transmission shall be as effective as delivery of a manually executed counterpart of this
Agreement. 
 Section 12.11 Further Assurance. Each Party undertakes, at the request and cost and expense of the other Party, to
sign all documents and to do all other acts, which may be necessary to give full effect to this Agreement. 
 Section 12.12
Governing Law. This Agreement shall be governed by, and construed in accordance with, the Laws of the State of New York, excluding its conflicts of laws principles. 

Section 12.13 Governing Language. The official text of this Agreement shall be the English language, and any interpretation or
construction of this Agreement shall be based thereon. If this Agreement or any documents or notices relating to it are translated into another language the English version shall be controlling in the event of discrepancy between the two. 

Section 12.14 Arbitration. 

(a) The Parties recognize that disputes as to certain matters may from time to time arise which relate to either Party’s rights or
obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation. To accomplish this objective, the Parties agree to
follow the procedures set forth in this Section 12.14, if and when a dispute arises under this Agreement. 
 (b) In the event of a
dispute between the Parties, the Parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within 30 days either Party
may commence arbitration as set forth below. 
 (c) All disputes arising out of or in connection with this Agreement shall be finally settled
under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules. Such arbitration shall take place in New York, New York. The language of the arbitration shall be
English. The arbitration award so given shall be a final and binding determination of the dispute and shall not include any damages expressly prohibited by Section 8.5. Except in a proceeding to enforce the results of the arbitration or as
otherwise required by Law, neither Party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both Parties. 

  
 25 

 (d) Notwithstanding the foregoing dispute resolution procedure, in the event of an actual or
threatened breach hereunder, the aggrieved Party may seek equitable relief (including restraining orders, specific performance or other injunctive relief) without submitting to such dispute resolution procedure if there is a reasonable likelihood of
the occurrence of irreparable harm during the period of the dispute resolution procedure. 
 Section 12.15 Press Releases. 

(a) Subject to Section 12.15(b), press releases or other similar public communications by a Party relating to this Agreement shall be
subject to a right of reasonable prior review and approval by the other Party, which approval shall not be unreasonably withheld or delayed, provided that such right of approval shall not apply to communications required by applicable Law,
disclosures of information for which consent has previously been obtained, or information that has been previously disclosed publicly, and provided, further, that any draft press release or other public communication submitted to a Party for
its approval shall be deemed approved if such Party fails to notify the submitting Party within 5 Business Days of receipt thereof as to whether or not it has been approved. 

(b) Distributor understands and agrees that Ampio may submit a copy of this Agreement to the United States Securities and Exchange Commission.

  
 26 

 The Parties have caused this Agreement to be executed by their respective duly authorized officers as of the date
first above written. 
  

			
	AMPIO PHARMACEUTICALS, INC.
		
	By:	 	 /s/ Michael Macaluso

		 	Name: Michael Macaluso
		 	Title: Chief Executive Officer
	
	FBM INDUSTRIA FARMACEUTICA, LTDA.
		
	By:	 	 /s/ Moises Alves de Oliveira Neto

		 	Name: Moises Alves de Oliveira Neto
		 	Title: Director
	
	FBM INDUSTRIA FARMACEUTICA, LTDA.
		
	By:	 	 /s/ Marcelo Reis Perillo

		 	Name: Marcelo Reis Perillo
		 	Title: DirectorEX-10.12

 Exhibit 10.12 

*** Text Omitted and Filed Separately with the Securities and Exchange Commission 

DISTRIBUTION AND LICENSE AGREEMENT 

THIS AGREEMENT is made on 9 April, 2014 (the “Effective Date”), between: 

Vyrix Pharmaceuticals, Inc. of 5445 DTC Parkway, Suite 925 Greenwood Village, CO 80111 USA (“Vyrix”) 

ENDO VENTURES LIMITED, of No. 33 Fitzwilliam Square, Dublin 2, Ireland (“Endo”)  

Background 
  

	A.	Vyrix is the registration, trademark holder and manufacturer of an orally disintegrating tablet containing 89 mg tramadol hydrochloride for treating premature ejaculation, known by Parties as the
“Product”. 

  

	B.	The parties wish for Endo to commercialize the Product in the Territory (as defined below). 

 Agreed Terms:

 INTERPRETATION 
  

	1.1	Definitions 

 In this Agreement: 

“Affiliate” means, with respect to a party to this Agreement, any other entity that Controls, is Controlled by, or is under
common Control with that party. 
 “Business Day” means a day on which Banks are open for general banking business in
Greenwood Village, Colorado, USA and Dublin, Ireland, excluding Saturdays, Sundays and public holidays in either Colorado, USA or Dublin, Ireland. 

“Calendar Year” shall mean any period of twelve consecutive calendar months commencing on January 1st and ending on
December 31st. 
 “Control” means the power of a person to secure either by means of the holding of a majority
(>50%) of shares, by contract, by reason of managerial powers or mandate or the possession of decisive voting power in or in relation to the company or corporation concerned or by virtue of any decisive powers conferred by the articles of
association or constitution or other document regulating that company or that corporation that its affairs are conducted in accordance with the wishes of that person. 

“Field” means the treatment of premature ejaculation. 

“Force Majeure” means events or occurrences beyond the reasonable control of the party affected, the effects of which could
not, by the exercise of reasonable diligence by that party, have been avoided and which affect the ability of that party to observe or perform its obligations under this Agreement, except for the failure or inability to pay any sum of money, such
events including: 

	 	(a)	war, invasion, riot, civil or military disturbances or sabotage; 

  

	 	(b)	strikes, picketing or other labour disputes or disturbances or work to rule; 

  

	 	(c)	lightning, fire, flood or threat of floods, earthquake and vulcanic smoke, storm, cyclone or explosion; 

  

	 	(d)	outbreak of diseases and pandemia restricting normal commerce, travel and transport of freight; 

  

	 	(e)	governmental restrictions or other governmental actions or inactions (unless such restrictions, action or inactions arise out of the failure of the party affected to comply with any governmental requirements).

 “Health Canada”, means the Canadian regulatory agency responsible for the evaluation and approval of
pharmaceutical drugs for human use and having the authority to grant Marketing Authorization in Canada. 
 “Improvements”,
in respect of the Product means any changes to the Product including, without limitation, in dosage strength, form, packaging or other advances in modifications or changes made by Vyrix to the Product to be used in the Field. For the avoidance of
doubt, the Parties agree that “Improvements” does not include Vyrix’s proposed tramadol-sildenafil combination tablet. 

“Intellectual Property Rights” means intellectual property rights of any nature whatsoever including such rights comprised in
patents, copyright, designs, trade marks whether or not registered, trade secrets and know-how and in goodwill and reputation, and all other similar rights, whether existing at common law or conferred by statute, rights to apply for registration
under law in respect of these or like rights and rights to protect trade secrets and know-how. 
 “Launch” and
“Launch Date” shall mean the first commercial sale and the date of the first commercial sale of the Product to third party customers in the Territory by Endo or its Affiliates or licensees following the issuance of the Marketing
Authorization, respectively. 
 “Long term Inability to Supply” means inability to supply at least seventy percent
(70%) of the volumes of Product indicated in the purchase orders provided by and confirmed by Endo, that continues for more than one hundred and twenty (120) days, to start after the stipulated delivery date, defined in Section 6.5.

 “Marketing Authorization” shall mean (i) with respect to Canada, the final regulatory approval granted by the
regulatory authorities in the form of a notice of compliance issued to and in the name of Endo in respect of the Product on the basis of the New Drug Submission, authorizing Endo to lawfully market and sell the Product in Canada, and (ii) for
all other countries in the Territory, final approval of a new drug application, health registration, marketing authorization application, common technical document, regulatory submission, notice of compliance or equivalent (but in no event to
include any applicable pricing or reimbursement approval) necessary to authorize Endo to lawfully market and sell the Product. 

  
 2 

 “MCC” shall mean the Medicines Control Council of South Africa and/or any other
regulatory authority in South Africa responsible for the evaluation and approval of pharmaceutical drugs for human use and having the authority to grant Marketing Authorization. 

“Net Sales” means with respect to a Product, the gross amount invoiced for sales of any Product in the Territory in arm’s
length sales by Endo (and its authorized affiliates and/or sublicensees) to Third Parties, less the following deductions from such gross amounts which are actually incurred, allowed, accrued or specifically allocated to such Product:
(i) credits, price adjustments or allowances for damaged products, returns or rejections of Product; (ii) normal and customary trade, cash and quantity discounts, allowances and credits (other than price discounts granted at the time of
invoicing which have already been included in the gross amount invoiced); (iii) chargeback payments, repayments and rebates (or the equivalent thereof) granted to or imposed by group purchasing organizations, managed health care organizations
or federal, state/provincial, local and other governments, including any or all of their regulatory authorities, agencies, review boards or tribunals, or trade customers; (iv) any invoiced freight, postage, shipping, insurance and other
transportation charges; (v) sales, value-added (to the extent not refundable in accordance with applicable law), and excise taxes, tariffs and duties, and other taxes directly related to the sale (but not including taxes assessed against the
income derived from such sale); (vi) stocking allowances; and (vii) any other payment which reduces gross revenue and is permitted to be deducted in calculating net sales in accordance with GAAP. 

“Pack” shall mean commercial packaged Product in final, finished goods form, consisting of six (6) tablets in a printed
foil blister tray, in a four (4) color box with a one (1) black & white package insert. 
 “Product”
shall mean orally disintegrating tablets containing 89mg tramadol hydrochloride as the active ingredient, suitable for distribution in accordance with the Specifications listed under Schedule 1 of this Agreement and all Improvements thereto. 

“Regulatory Approval” means, for each country, each considered separately, an authorisation from the relevant regulatory
authority for the import, distribution, marketing and/or sale of the Product. 
 “Regulatory Approval Date” means the date
that the relevant regulatory agencies in a given Country in the Territory granted Regulatory Approval to the Product. 

“Royalties” shall have the meaning ascribed in Section 9.5 of this Agreement. 

“Short Term Inability to Supply” means inability to supply at least seventy percent (70%) of the volumes of Product
indicated in the purchase orders provided by and confirmed by Endo, that continues for more than thirty (30) days but less than one hundred and twenty (120) days, starting after the stipulated delivery date, defined in Section 6.5.

 “Specifications” means the specifications for the Product as set forth in Schedule 1 attached to this Agreement. 

“Sponsor” means the party holding the Regulatory Approval for the Product. 

“Sublicense” has the meaning ascribed thereto in Section 3.3. 

“Term” has the meaning ascribed thereto in Section 2. 

  
 3 

 “Territory” means Canada, the Republic of South Africa, Sub Saharan Africa,
Colombia and Latin America, as described in Schedule 3 of this Agreement. 
 “Trade Marks” means the trade marks as listed
in Schedule 2 of this Agreement. 
 “Transfer Price” has the meaning ascribed thereto in Section 9.1. 

“Upfront Payment” has the meaning ascribed thereto in Section 9.3. 

“Vyrix IP” means all Intellectual Property Rights that subsist in: 

 

	 	(a)	the Product, including methods and processes for its production and storage and its use in the life sciences; 

  

	 	(b)	Vyrix’s marketing and informational materials; 

  

	 	(c)	the Improvements; 

  

	 	(d)	the Vyrix Patents, the Vyrix Know-How and the Trade Marks; 

  

	 	(e)	the colour scheme and the art work on the Pack (if not designed by Endo); 

 and all other
intellectual property rights that Vyrix owns. 
 “Vyrix Know-How” means Confidential Information relating to the manufacture
and sale of the Product owned or Controlled by Vyrix. 
 “Vyrix Patents” means those patents in Vyrix’s name (or
otherwise assigned to Vyrix) that claim the Product or an aspect of the process of making it and any other aspect of it, and all patents that derive priority from the same priority document and all other patents and patent applications in the same
patent family, including all corresponding national phase filing, divisional application and continuations. These are listed in Schedule 2 of this Agreement. 
  

	1.2	Interpretation 

 In this Agreement, unless the context otherwise requires: 

 

	 	(a)	words importing natural persons include corporations, firms, unincorporated associations, partnerships, trusts and any other entities or groups recognized by law; 

 

	 	(b)	reference to any legislation or to any provision of any legislation includes any amendment, modification, consolidation or re-enactment of, or any legislative provision substituted for, and all legislative and statutory
instruments issued under, such legislation or such provision; 

  

	 	(c)	the words “written” and “in writing” include any means of visible reproduction of words in a tangible and permanently visible form; 

 

	 	(d)	reference to any party to this Agreement or any other agreement or document includes the party’s successors and permitted assigns; 

  
 4 

	 	(e)	reference to any document or agreement includes references to such document or agreement as novated, supplemented, varied or replaced from time to time except to the extent excluded by the terms of this agreement or
that other document or agreement; 

  

	 	(f)	no rule of construction applies to the disadvantage of a party because that party was responsible for the preparation of this Agreement or any part of it; 

 

	 	(g)	where the day on, or by, which any thing is to be done is not a Business Day, that thing shall be done on, or by, the next following Business Day; and 

 

	 	(h)	the headings to sections, clauses or schedules are for ease of reference only and do not form part of this Agreement or affect its interpretation. 

 

	2.	TERM 

 This Agreement commences on the Effective Date and will, subject to the provisions
for termination herein, expire on a country-by-country basis the later of (i) the expiration of market exclusivity for the Product in that country, or (ii) fifteen (15) years after the first commercial sale of the Product in that
country. The term of this Agreement shall automatically continue after expiry hereof on a country-by-country basis for consecutive three (3) year periods, unless Vyrix delivers to Endo written notice of termination in respect of that country at
least six (6) months prior to the end of that term. 
  

	3.	APPOINTMENT AND GRANT OF RIGHTS 

  

	3.1	Appointment. Vyrix appoints Endo as Vyrix’s exclusive distributor for marketing and selling the Product in the Territory and Endo accepts such appointment and agrees to use commercially reasonable efforts to
market, distribute and sell the Product subject to the terms and conditions set out in this Agreement. 

  

	3.2	Grant of Rights – the Product. Subject to the terms and conditions in this Agreement, Vyrix grants to Endo an exclusive license to the Vyrix IP in the Territory, as per the stipulations made in
Section 3.1, with the right to: 

  

	 	(a)	market, promote, import into the Territory, offer for sale and sell the Product for use in the Field; 

  

	 	(b)	use the Trade Marks and reproduce the Vyrix marketing materials in accordance with the provisions of Section 11; 

  

	 	(c)	design its own packaging for the Product, and market the Product under its own trademark or any other trademark in the Territory; and 

 

	 	(d)	use the Vyrix Know-How to exercise its rights and perform its obligations set out in this Agreement 

(the “License”); and provided that Vyrix may continue to use the Vyrix IP in the Territory for any purpose other than
marketing, distributing and selling the Product in the Territory. 
 The Right to Grant Sublicenses. Endo is entitled to grant
sublicenses under the License that comply with Section 3.4 (“Sublicense”) to its Affiliates and third parties. When Endo wishes to enter into a Sublicense with a third party (but not an Affiliate), subject to written consent

  
 5 

 
of Vyrix which shall not be unreasonably withheld, Endo shall deliver to Vyrix at least one (1) month’s advance written notice of its intention to enter into a Sublicense agreement, by
which Endo shall inform Vyrix of all the principal terms of such agreement, including the identity of the proposed sublicensee. Endo does not need to notify Vyrix upon granting a sublicence to an Affiliate in the Territory. 

 

	3.3	The Content of Sublicenses. Endo is entitled to grant Sublicenses under the License, that in all material respects: 

  

	 	(a)	are in writing; 

  

	 	(b)	contain a scope of rights which are no greater than the scope of rights granted under Section 3.2; and 

  

	 	(c)	contain express provisions that: (i) require the sublicensee to comply with Section 5 (Marketing and Commercialization) and Section 11 (Intellectual Property), (ii) automatically terminate the
Sublicense agreement upon termination of this Agreement. 

  

	3.4	Endo to Remain Liable. Endo shall be liable to Vyrix for its Sublicensees acts and omissions under each Sublicense agreement. If a Sublicensee makes a claim against Vyrix whether by way of damages, costs or
expenses or otherwise, Endo agrees to be voluntarily joined as a party to such claim. 

  

	3.5	License Qualifications and Clarifications.  

  

	 	(a)	This Agreement shall not grant to Endo or to any Affiliate of Endo or to its Sublicensees any rights or licenses other than the rights and licenses expressly provided for in this Agreement. 

 

	 	(b)	Vyrix hereby represents that it owns the Vyrix IP and, Endo acknowledges that, subject to the express grant of the licenses hereunder to Endo, Vyrix has the right to use and otherwise exploit the Vyrix IP in the Field
outside the Territory and outside the Field in the Territory. 

  

	 	(c)	For the avoidance of doubt, Vyrix shall be entitled to supply Product and enter into licences and other types of transaction for or related to the supply of Product: 

 

	 	(i)	to any third party outside the Territory for any use; 

  

	 	(ii)	to third parties in the Territory for non-commercial use in the Field, such as research partners. 

  

	 	(d)	Vyrix shall not use the Product Trade Mark in the Territory. 

  

	 	(e)	If Endo knows or reasonably suspects that any person outside the Territory has or will import the Product into the Territory, for use in the Field, Vyrix shall use commercially reasonable efforts to assist Endo to stop
such unauthorized import and sale activities and to mitigate any losses suffered by Endo. Subject to Vyrix complying with such covenant, Vyrix shall not be liable to Endo if third parties import the Product into the Territory or offer the Product
for sale in the Territory in the Field. 

  
 6 

	 	(f)	Endo will not at any time during the Term seek customers in any place which is outside the Territory. 

  

	 	(g)	Endo will not at any time during the Term, supply the Product to any person outside the Territory or for use outside the Field or within the Territory if Endo knows or has reason to believe that such person intends to
resell or re-supply the Product outside the Territory. In the event that Endo becomes aware of any person selling the Product that has been supplied by Endo outside the Territory, Endo shall notify Vyrix in writing and shall take reasonable steps to
prevent such re-sale. 

  

	3.6	Improvements. Vyrix grants Endo an exclusive license in the Territory for all Improvements to the Product. 

  

	3.7	Right of First Negotiation. Endo has the right of first negotiation to include Vyrix’s tramadol-sildenafil combination tablet (“Zertane-ED”) as an additional product under this Agreement,
subject to separate economic considerations. Vyrix will notify Endo by registered mail or courier no less than six (6) months prior to the anticipated filing date for the regulatory dossier for Zertane-ED in the United States. During a period
of ninety (90) days, the parties will negotiate in good faith an amendment to the Definitive Agreement, with respect to Zertane-ED. If the Parties are unable to agree on such amendment within the ninety (90) day period, starting from
postdate of notice, Vyrix is free to solicit a third party for Zertane-ED and to sell and market such product in the Territory, unless both Parties agree on extending the negotiation period. For clarity, a New Product does not include Improvements
to the Product, which are listed in the Improvements section of this Agreement. 

 The foregoing Section 3.7 shall not be
construed to allow Endo to make use of Vyrix’s Know-How without prior written consent of Vyrix. 
  

	4.	PRODUCT REGISTRATION 

  

	4.1	Marketing Authorisation and Launch. Endo shall use commercially reasonable efforts to apply for Regulatory Approval, and launch the Product in the Territory. Endo shall solely bear all the costs and expenses of,
and related to, preparing, filing and prosecuting such regulatory applications and maintaining the corresponding approvals. 

  

	4.2	Regulatory Approval. Endo shall be responsible for maintaining the Regulatory approval/license in Canada and all equivalent registrations in other countries in the Territory. Subject to the provisions for
termination in Section 12, Endo shall retain ownership of the said approval/license and equivalent registrations. 

  

	4.3	Assistance. Within sixty (60) days of the Effective Date, Vyrix will deliver to Endo all data, records and reports (including pre-clinical and clinical reports) necessary for Endo to make a regulatory
submission to Health Canada as well as all other regulatory filings required to commercialize the Product in the other countries in the Territory. In addition, Vyrix will provide Endo with all reasonable assistance during the Term, in support of
Endo’s applications for Regulatory Approval for the Product in the Territory, including: 

  

	 	(a)	reasonable telephone and email communication; 

  
 7 

	 	(b)	modular based and sales focused comprehensive product training material; 

  

	 	(c)	additional information that may be requested by Health Canada (including, by way of example, stability information); 

  

	 	(d)	facilitating an inspection of Vyrix’s manufacturing facilities if required by regulatory authorities; and 

  

	 	(e)	making its personnel available by email and telephone as reasonably required. 

 The assistance
to be provided by Vyrix under this Section 4.3 is in support of Endo’s performance of its obligations under Section 4.1 for which Endo shall retain primary responsibility. 

 

	5.	MARKETING AND COMMERCIALIZATION 

  

	5.1	Comply with Laws. Endo will be responsible for all the duties and responsibilities laid down for marketing authorization holders by the laws and regulations in the Territory, which shall be considered on a
country by country basis. Endo shall be responsible for compliance with any and all applicable laws, rules and regulations of the Territory with respect to the marketing, distribution, promotion and sale of Product. Endo shall be responsible at its
own cost and expense to obtain and maintain throughout the Term all import licenses, registrations, licenses, permits, and approvals that are necessary to carry out all such activities. 

 

	5.2	Diligence - General. Endo will use reasonable commercial efforts to promote, market and sell the Product in the Territory consistent with products of similar commercial value as determined by Endo. Endo shall
also use reasonable commercial efforts to maintain a quantity of inventory for the Product necessary to meet Product demand in the Territory as determined by Endo from time to time. 

 

	5.3	Promote Reputation. Endo shall not knowingly: (i) disparage in any manner the Product, (ii) nor the Trade Marks, nor (iii) attempt to register or otherwise assert any rights in or to any Trade Marks.

  

	5.4	Information Exchange. Each party shall communicate to the other information relevant to the distribution, marketing and sale of the Product in the Territory, including: 

 

	 	(a)	customer complaints in relation to the Product; 

  

	 	(b)	in the case of Endo: 

  

	 	(i)	any inquiries made by any person regarding sales or potential sales of the Product outside the Territory or outside the Field; 

  

	 	(ii)	monthly sales of Product in the Territory reported on an a quarterly basis; and 

  

	 	(iii)	stock levels at the end of the quarter. 

  

	 	(c)	scientific and other information that such party generates or of which it becomes aware; 

  

	 	(d)	facts or opinions likely to be relevant in relation to the marketing of the Product; and 

  
 8 

	 	(e)	Endo will notify Vyrix of any potential clinical collaborators or research endeavors related to the Product that they become aware of. 

 

	6.	ORDERING AND SUPPLY OF PRODUCT 

  

	6.1	Ordering. Endo shall order Product from Vyrix by delivering to Vyrix a written order that specifies: 

  

	 	(a)	the quantity of Product being ordered; 

  

	 	(b)	whether the Product is to be received in bulk tablet or as finished Pack format; 

  

	 	(c)	Endo’s requirements for the Pack labelling, which must comply with Sections 11.2 through 11.7; and 

  

	 	(d)	the port(s) of destination for delivery. 

  

	6.2	Forecasts. Three (3) months prior to the Launch Date reasonably expected by Endo in the Territory and within the first (1st) month of each Calendar
Year thereafter, Endo shall provide to Vyrix a good faith forecast setting forth amounts of Product that Endo expects in good faith to order for the first twelve (12) calendar months following the expected Launch Date with respect to the first
such forecast and for the twelve (12) calendar month period following the delivery of the forecast thereafter. 

  

	6.3	First Order. The first order placed by Endo shall have a lead time of four (4) months after approval of printing proofs. 

 

	6.4	Delivery. Subject to Endo being in compliance with its payment obligations under Section 9.7, Ethypharm shall deliver to Endo Product that Endo orders in accordance with Section 6.1. Delivery shall be
Ex-works (Incoterms 2010) Ethypharm’s facility (Saint-Cloud, France) with the delivery designated for a port to be specified by Endo: (i) for Canada, the Port of Montreal, (ii) for Africa, in Durban (Kwazulu-Natal) and (iii) for
Mexico, to be determined upon Endo placing the first order. Endo shall be responsible for and bear all freight, insurance and other shipping expenses and all applicable taxes or duties that may be assessed against the Product after delivery.

  

	6.5	Time for Delivery. The time for delivery under Section 6.4 shall be the later of three (3) months after Vyrix’s receipt of Endo’s order or three (3) months after Endo’s approval of
packaging artwork, except for the first order which is described in Section 6.3. 

  

	6.6	Change of Manufacturer. Provided it has no negative impact on the Regulatory Approval in the Territory, Vyrix has the right to subcontract manufacturing by providing Endo with no less than six (6) months
advance notice of any change in manufacturer not listed in the regulatory dossier for the Product as of the Effective Date. 

  

	6.7	Title and Risk. Risk of loss for Product shall pass to Endo upon delivery under Section 6.4. 

  
 9 

	7.	DELAY AND FAILURE TO SUPPLY 

  

	7.1	Short Term Inability to Supply. Vyrix acknowledges that punctual delivery is key to successful execution of the Agreement and that it shall deliver the Product in a timely manner. 

In the event that Vyrix experiences a Short Term Inability to Supply, for any reason other than as a result of Force Majeure, Vyrix shall
rescind the requirements for payment of Royalties to Vyrix as listed in Section 9.5 for an equivalent period of time of any resulting direct loss of sales (by virtue of a product backorder). The foregoing shall be without prejudice to any other
rights or remedies available to Endo under the Agreement and the applicable law. 
  

	7.2	Long Term Inability to Supply. In the event of any Long Term Inability to Supply the Product in the Territory, the parties agree to act in good faith and make all commercially reasonable efforts to find a
mutually acceptable solution to the Long Term Inability to Supply. 

 In addition, in the event of (i) a Long Term
Inability to Supply or (ii) the happening of any of the events set out in Sections 12.1(b) to 12.1(d) in respect of Vyrix, the following shall occur: 
  

	 	(a)	In the event that Vyrix experiences a Long Term Inability to Supply, for any reason other than as a result of Force Majeure, Vyrix shall rescind the requirements for payment of Royalties to Vyrix as listed in
Section 9.5 for an equivalent period of time of any resulting direct loss of sales (by virtue of a product backorder). The foregoing shall be without prejudice to any other rights or remedies available to Endo under the Agreement and the
applicable law. 

  

	 	(b)	Vyrix shall transfer/initiate production of the Product at a secondary manufacturer as specified in the Quality Agreement in order to manufacture and supply the Product for the Territory. 

 

	 	(c)	Any costs for the transfer and/or initiation of production at the referred to in Section 7.2 (b), to the extent required for the Territory, shall be borne by Vyrix. 

 

	 	(d)	The supply price for Product manufactured and supplied to Endo by the secondary manufacturer shall be the same or lower than the prices paid by Endo as per Section 9.1 of this Agreement. 

 

	 	(e)	The minimum order quantities shall be no larger than those set out in Section 9.1 of this Agreement, and may be smaller based on the batch size of the third party manufacturer, which shall be provided to Endo. In
the case that batch sizes are larger than those listed in Section 9.1, Endo shall have the right to purchase a partial batch, with any additional costs due to this partial batch production to be borne by Vyrix. 

 

	7.3	No diversion of Product. In no event shall Vyrix ship Product originally destined to be shipped to Endo due to a valid purchase order placed by Endo to countries outside the Territory. 

 

	7.4	 Multiple Inability to Supply issues. If Endo is faced with two (2) or more Short or Long Term Inability events in two (2) consecutive
years that result in a direct loss of sales (by virtue of a product backorder), Vyrix will reduce Endo’s obligation to pay Vyrix Royalties as listed in Section 9.5 by fifty percent (50%) for a period of time equal to the longest
period of product backorder during the previous two (2) years. This is in addition to any remedy owing to an 

  
 10 

	 	
Inability to Supply issue as outlined in Sections 7.1 and 7.2. The reduction in Royalty payment described in this Section owing to multiple Inability to Supply issues will start no earlier than
at the end of any other period of Royalty reduction outlined in Sections 7.1 and 7.2. 

  

	8.	TESTING AND INSPECTION 

  

	8.1	Sampling and Quality Control. Prior to each delivery of Product to Endo, Vyrix shall be responsible for all sampling and quality control testing of the Product in accordance with the methods of analysis set forth
in the Specifications, required to determine whether the Product conforms to the Specifications. 

  

	8.2	Certificates. For each batch of Product to be delivered to Endo hereunder, Vyrix shall provide copies of the complete certificate of analysis and certificate of compliance at time of delivery, as well as copies
of any other documents required by any governmental authority. 

  
 11 

	8.3	Defective Product. Endo will inspect the Product delivered for damages of the outer packaging material identifiable by means of a sight test (“Apparent Defects”), shortages in order quantity, or
failure in any material way to comply with the Warranty set forth in Section 13.1 and will notify Vyrix of any Apparent Defects, shortage, or failure with respect to Section 13.1 within thirty (30) days of receipt by Endo. Endo will
notify Vyrix of any hidden or latent defects (i.e. defects other than Apparent Defects), of which it becomes aware, within thirty (30) days following discovery of the defect. Within the above-mentioned time-frames Endo is entitled to reject the
defective Product or the batch containing defective Product. In the event of a Product rejection, the parties shall immediately endeavor to agree whether or not the delivery in question is defective. If the parties fail to agree, the matter shall be
determined by an independent expert or laboratory and the decision of the independent expert shall be final and binding on the parties. The independent expert shall act as an expert and not as an arbitrator and its fees shall be borne by Vyrix if it
is determined that defects exist and by Endo if it is determined that no defects exist. In order to avoid further delays, Endo shall be entitled to request that Vyrix supplies a supplementary delivery of the same kind and amount of Product
(“Supplementary Delivery”) as soon as reasonably possible (at Endo ́s sole discretion and cost by airfreight), but in no event later than within one (1) month following notification by Endo to Vyrix of the nature of the
defect in the Product, and Vyrix shall comply with such request. The results obtained by such independent expert or laboratory shall be binding upon the parties, and the costs of such analyses shall be borne by the party whose test results are not
upheld by such independent laboratory testing. 

  

	8.4	If Vyrix agrees or the independent expert finds that any delivery of the Product is defective, then Vyrix shall promptly replace the delivery in question (and in no event any later than within one (1) month) by
airfreight or the fastest possible means of transport under the circumstances, at no additional cost to Endo. If Endo requested a Supplementary Delivery in accordance with the foregoing paragraph, such Supplementary Delivery shall be considered to
be a replacement delivery in accordance with the foregoing sentence. All costs and expenses incurred by Endo in connection with Defective delivery (including, without limitation, the cost of the Supplementary Delivery, and return or disposal of the
defective Product) shall be borne by Vyrix. Vyrix shall promptly inform Endo whether the Defective delivery shall be disposed of or returned to Vyrix. 

  

	8.5	If a delivery of the Product is found by the independent expert not to be defective, Endo shall pay for such delivery in accordance with the payment provisions contained in this Agreement. If Endo requested a
Supplementary Delivery in accordance with this Section 8, such Supplementary Delivery must be paid for by Endo separately. 

  

	8.6	 Recall. In the event that Endo is required by Health Canada or any regulatory authority in the Territory to recall a Product or in the event
either party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, the party notified of such recall or similar action, or the party that desires such recall
or similar action, shall within twenty-four (24) hours, advise the other party thereof by telephone or facsimile (with written confirmation notice to follow). Endo, in consultation with Vyrix, shall decide whether to conduct any recall in the
Territory, although Endo shall have final decision-making authority on whether to conduct such recall (except in the case of a government mandated recall, in which case either party may act without such advance notice but, shall notify the other
party as soon as possible) and the manner in which any such recall shall be conducted; provided however that Endo shall initiate a recall upon Vyrix’s request in the event that Vyrix reasonably believes that such a recall is required due to
non-compliance with applicable laws and regulations in the 

  
 12 

	 	
Territory. Vyrix will make available to Endo, upon request, all of Vyrix’s pertinent disclosable records that Endo may reasonably request to assist Endo in effecting any recall. If such a
recall arises as a result of an act of omission,an infringement or a misrepresentation in Endo’s storage, handling, promotion, advertising or distribution of the Product, Endo shall bear the costs and expenses of the recall for the Territory.
In all circumstances due to any act or omission on behalf of Vyrix, Vyrix shall bear all the costs and expenses associated with such a recall. 

  

	9.	PRICES AND PAYMENTS 

  

	9.1	Transfer Price. The price payable by Endo for Product (the “Transfer Price”) shall not exceed the prices set forth below: 

 

	 	(a)	Batch size of approximately [...***...] tablets: Not to exceed USD$ [...***...]/tablet (bulk packaged). 

  

	 	(b)	Batch size of approximately [...***...] tablets: Not to exceed USD$ [...***...]/tablet (bulk packaged). 

  

	 	(c)	Batch size of approximately [...***...] tablets: Not to exceed USD$ [...***...]/tablet (bulk packaged). 

The above pricing shall be reflective of the pricing provided to Vyrix by Ethypharm, with no additional mark-up on pricing by Vyrix except for
any necessary taxes costs to be billed as incurred. 
  

	9.2	Price Adjustments. Vyrix shall not increase the prices in Section 9.1 for a period of two (2) years following the Launch Date of the Product provided that Vyrix is not losing money either directly or as
a result of currency exchange. At any time after the second (2nd) anniversary of the Launch Date of the Product in each country in the Territory, Vyrix shall be entitled to increase the
prices specified in Section 9.1, but not more than once per Calendar Year. Vyrix shall consult with Endo in relation to the reasons for its intended price increase and deliver to Endo at least six (6) months advance written notice of a
proposed increase in price and demonstrate based on reasonable documentary evidence that the proposed price increase corresponds exclusively to an increase in the prices of Ethypharm’s raw materials, production and manufacturing processes. If
the prices of Ethypharms’s raw materials, production and manufacturing processes decrease by more than five percent (5%), Vyrix shall pass on those price decreases to Endo. 

 

	9.3	Upfront Payments. 

 Upon signing of this Agreement, within five (5) Business Days
Endo will pay via wire to Vyrix two hundred and fifty-thousand US Dollars ($USD 250,000). 
  

	9.4	Milestone Payments. 

  

	 	(a)	Upon regulatory approval of the Product in Canada, within five (5) Business Days Endo will pay via wire to Vyrix [...***...]. 

 

	 	(b)	Upon regulatory approval of the Product in the Republic of South Africa, within five (5) Business Days Endo will pay via wire to Vyrix [...***...]. 

  
 13 

	 	(c)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “First Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the First Net Sales Threshold is achieved. 

  

	 	(d)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “Second Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the Second Net Sales Threshold is achieved. 

  

	 	(e)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “Third Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the Third Net Sales Threshold is achieved. 

  

	 	(f)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “Fourth Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the Fourth Net Sales Threshold is achieved. 

  

	 	(g)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “Fifth Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the Fifth Net Sales Threshold is achieved. 

  

	 	(h)	If Net Sales of the Product in any Calendar Year exceed [...***...] (the “Sixth Net Sales Threshold”), Endo shall pay Vyrix [...***...]. This Milestone Payment shall only be due once, if at
all, and shall be due and payable sixty (60) days following the end of the applicable Calendar Year in which the Sixth Net Sales Threshold is achieved. 

For the avoidance of doubt, the Net Sales Thresholds are cumulative, meaning that (a) should they all be achieved Endo shall owe Vyrix a
total aggregate amount of (and never exceeding) three million and twenty five thousand US dollars ($USD 3,025,000), and (b) such First, Second, Third, Fourth, Fifth, Sixth, and Seventh Net Sales Thresholds may be achieved in one or more
Calendar Years as applicable. 
  

	9.5	Royalties. Commencing with the calendar quarter in which Launch of the Product is made in the Territory, Endo shall pay Vyrix a non-creditable, non-refundable Royalty, in immediately available funds, in an amount
equal to one of the following (the “Royalties”): 

  

	 	(a)	[...***...] percent ([...***...]%) of Net Sales in any Calendar Year should the Net Sales in that Calendar Year be less than or equal to [...***...] or; 

 

	 	(b)	[...***...] percent ([...***...]%) of Net Sales should the Net Sales in that Calendar Year exceed [...***...]. 

No later than forty-five (45) days after the end of each calendar quarter, Endo shall report to Vyrix the Net Sales of the Product sold by
Endo in the Territory and the Royalties due to Vyrix for such period. The payment by Endo to Vyrix shall be made within sixty (60) days after the end of each calendar quarter, subject to a true-up within sixty (60) days of the end of the
Calendar Year should Net Sales cross the [...***...] threshold. 

  
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	9.6	Royalty Term. Endo shall pay to Vyrix the Royalties described in Section 9.8 above on a country-by-country basis in the Territory until the later of (i) the expiration of market exclusivity for the
Product in that country, or (ii) fifteen (15) years after the Launch of the Product in that country. 

  

	9.7	Payment. All amounts due to Vyrix shall be payable within thirty (30) days of receipt of an invoice from Vyrix, with the exception of Royalty payments to be paid as per Section 9.5 of this Agreement.

  

	9.8	Manner of Payment. All payments to Vyrix under this Agreement shall be made in United States Dollars by way of wire transfer to Vyrix’s nominated bank account. 

 

	9.9	Withholding Tax. If Endo is required by the applicable laws of any jurisdiction to deduct or withhold from any payment to Vyrix any taxes or charges which may be levied against Vyrix, Endo shall deduct or
withhold such taxes or charges in accordance with such applicable laws, and shall forthwith provide to Vyrix the reasons therefore. Endo shall promptly furnish Vyrix with copies of any tax certificate or other documentation evidencing such
withholding. 

  

	9.10	Currency Conversion. Payments under this Agreement based on sales amounts in a currency other than Canadian dollars shall first be calculated in the foreign currency and then the payment owing shall be converted
to Canadian dollars on the basis of the exchange rate in effect for the purchase of Canadian dollars with such foreign currency quoted by the Bank of Canada on the date that the payment is made. 

 

	10.	RECORDS AND INSPECTION 

  

	10.1	Endo to Report. Within forty-five (45) days of each calendar quarter during the Term, Endo shall deliver to Vyrix a written report of all the Net Sales of Product recorded by it and by its Affiliates, as
well as the stock level at the end of the quarter, on a country by country basis during the calendar quarter preceding the date of the report. 

  

	10.2	Vyrix’s Right to Inspect Records. Endo must maintain the records described in Section 10.1 for a minimum of three (3) years and make them available for inspection by Vyrix’s accountants or auditors
upon reasonable written request from Vyrix. Vyrix acknowledges that all records are Confidential Information of Endo and that it shall be entitled to inspect those records once every twenty four (24) months. Vyrix must pay the costs
associated with the audit; provided that if any such audit shows that payments to Vyrix have been understated by five percent (5%) or more, the cost of such audit shall be borne by Endo. 

 

	11.	INTELLECTUAL PROPERTY 

  

	11.1	Ownership. Endo acknowledges and agrees that, as between the parties, Vyrix owns all of the Vyrix IP and that Vyrix shall retain ownership of all the Vyrix IP. 

 

	11.2	Use of the Trade Marks. Endo agrees that each Pack of Product shall bear the following language, and that Endo shall not market, promote, offer for sale or sell the Product without each Pack bearing the following
language: “Licensed from Vyrix Pharmaceuticals, Inc.” 

  
 15 

	11.3	Pack Modifications. Subject to Endo complying with Sections 11.1, 11.2 and 11.4, Endo may modify the Pack, with Endo assuming such costs. 

 

	11.4	Quality Standards. Vyrix shall be entitled to prescribe from time to time such reasonable standards of manufacture, quality and performance as appear to Vyrix to be necessary to ensure the maintenance of the good
quality and reputation of the Product and Endo shall use reasonable efforts to observe each and every one of the said quality standards provided they do not impact the Regulatory Approval in the Territory. Endo shall not market, promote nor sell
Product which does not comply with the said quality standards without Vyrix’s informed prior written consent. 

  

	11.5	Maintenance of Trade Marks and Domain Name. Vyrix shall, at its expense, take all such steps as Vyrix deems reasonably required to maintain the validity and enforceability of the Trade Marks in the Territory
during the Term, including paying on or before the due date all registration and renewal fees. 

  

	11.6	Infringement of Rights. Endo shall promptly report to Vyrix any suspected infringement in the Territory of the Vyrix IP by third parties which it suspects or of which it becomes aware. Endo may take action in
respect of such infringement except if such action involves a counterclaim against the validity or existence of any Vyrix IP or IP licensed to Vyrix for the Product, in which case Vyrix shall assume the care and conduct of such proceedings. Endo
shall provide to Vyrix with all reasonable assistance in support of actions or suits that Vyrix initiates, including in the case of trade mark proceedings, with evidence of use. Any damages and costs recovered shall be split between Vyrix and Endo
on a 50/50 basis after first deducting all costs for such proceedings borne by Endo. 

  

	11.7	Vyrix’s Representations. Vyrix warrants that: 

  

	 	(a)	at the Effective Date, Vyrix owns or has been assigned the Vyrix IP; 

  

	 	(b)	to the best of its knowledge, the use of the Trade Marks and the exploitation of the Vyrix IP does not infringe the rights of any third party; 

 

	 	(c)	Vyrix has not misappropriated and is not aware of any misappropriation of any trade secrets of any third parties relating to the Product or the Vyrix IP; 

 

	 	(d)	Vyrix has not granted to any other third party any right or licence to market, distribute or sell the Product in the Territory which right is still in force and effect on the Effective Date; 

 

	 	(e)	Vyrix and/or its Affiliates is/are direct and exclusive owner(s) of all Vyrix IP as of the Effective Date, and do not license the Vyrix IP from any other party; 

 

	 	(f)	All Product manufactured and delivered to Endo shall comply in all material respects with all GMPs, Specifications and other regulations as required by Health Canada, MCC or other regulatory authorities in the
Terrritory; 

  

	 	(g)	All Product supplied by Vyrix to Endo hereunder shall, as of the time that such Product is delivered to Endo, have a minimum shelf life (at the time of delivery to the carrier’s vehicle by Vyrix for shipment at the
shipping point pursuant to Section 6.4) of the greater of (i) twenty (20) months, and (ii) four (4) months less than the shelf life set forth in the Regulatory Approval; 

  
 16 

	 	(h)	As of the date hereof and during the immediately preceding five (5) year period, there have not been any claims, lawsuits, arbitrations, legal or administrative or regulatory proceedings, charges, complaints or
investigations by any government authority or other third party threatened, commenced or pending against Vyrix and Vyrix has not received any notice of intellectual property infringement with respect to, the Product or the Vyrix IP, including
Vyrix’s right to manufacture, use, sell or license the Product. 

 Either party shall inform the other party in writing
without delay if any notice from a third party should be received by such party during the Term claiming such infringement, violation or misappropriation. 
  

	11.8	No Challenge by Endo. Endo shall not directly or indirectly challenge the validity or ownership of the Vyrix IP or challenge that the use of the Vyrix IP by Endo during the Term is only on behalf of Vyrix as a
licensee under its control. Endo shall not knowingly do, or authorize any third party to do, any act, which would or might invalidate or infringe any Intellectual Property of Vyrix and shall not knowingly omit or authorize any third party to omit to
do any act which, by its omission, would have that effect. 

  

	12.	TERMINATION 

  

	12.1	Termination by either Party. Either party may terminate this Agreement with immediate effect by written notice to such effect to the other party upon the happening of any of the following events:

  

	 	(a)	if the other party commits any material breach of the provisions contained in this Agreement and does not remedy the breach within sixty (60) days after receipt of written notice requiring it to do so and provided
that if the breaching party has proposed a course of action to cure the breach and is acting in good faith to cure same but has not cured same by the sixtieth (60th) day, such period shall be extended by a further period of up to an additional
thirty (30) days to permit the breach to be cured; 

  

	 	(b)	a petition or other application being presented or resolution being passed for the winding up, liquidation or dissolution of the other party or notice of intention to propose such a resolution being given or the entry
of the other party into a scheme of arrangement or compromise with any of its creditors; 

  

	 	(c)	the appointment of an administrator or a receiver or receiver and manager or official manager or agent of a secured creditor to any of the other party’s property; 

 

	 	(d)	the other party ceasing to carry on business or stopping or wrongfully suspending payment to any of its creditors or stating its intention so to do. 

 

	 	(e)	Either Party can remove a country from the Territory in the Definitive Agreement in the instance that the health authorities in the specified country in the Territory has refused regulatory approval (or equivalent in
the country in the Territory) of the Product. 

  

	 	(f)	Vyrix has the right to (partially) terminate the Definitive Agreement with respect to Canada, South Africa, or Mexco in the event that Endo has not applied for regulatory approvals to distribute the Product in such
jurisdiction prior to the first (1st) anniversary of the Effective Date, assuming sufficiency of the existing regulatory dossier unless Endo requires additional documentation and/or data from
Vyrix for the filing. 

  
 17 

	 	(g)	Vyrix has the right to terminate this Agreement entirely or partially with respect to a Country as determined by Vyrix for convenience without fault of Endo at any time following the fourth (4th) anniversary of the Effective Date by giving Endo not less than sixty (60) Calendar Days prior written notice. In such event, Vyrix shall be obliged to pay the greater of (a) all
sales and marketing costs incurred by Endo as of the Effective Date, or (b) two (2) times Endo’s Net Sales of the Product in the Country of termination in the preceeding twelve (12) month period, provided that all outstanding
sales (including orders received, but not yet processed or shipped) and backorders are included in the calculation of Net Sales. 

  

	 	(h)	In case of termination, Endo shall notify the health authorities in the specific country(ies) in the Territory if applicable. 

  

	 	(i)	On the earlier of expiry or termination of the Agreement in relation to the Territory, Endo shall transfer to Vyrix ownership of the regulatory dossier(s) in the Territory and provide to Vyrix details of the amount of
Product in Endo’s possession. 

  

	12.2	Right of (Partial) Termination by either Party for lack of Regulatory Approval. Either Party can partially terminate the Agreement with a respect to a country from the Territory where the competent regulatory
authority has refused Regulatory Approval (or equivalent in the country in the Territory) of the Product. 

  

	12.3	Non-renewal by Vyrix. Should Vyrix elect not to renew the Agreement, Vyrix shall provide six (6) months written notice prior to the end of the current term of such intention. 

 

	12.4	Right of Termination by Endo. Endo may terminate the Agreement at any time, giving Vyrix not less than six (6) months written notice. 

 

	12.5	Consequences of (Partial) Termination. On the earlier of expiry or termination of this Agreement in relation to the entire Territory or partially, on a country by country basis as the case may be:

  

	 	(a)	Endo’s rights and licenses under Section 3 shall expire and cease being of force or effect and Endo shall not promote or market the Product, except as provided under Section 12.7; 

 

	 	(b)	Endo shall transfer to Vyrix or any party it designates the Regulatory Approval for the Production the Territory; 

  

	 	(c)	Endo shall provide to Vyrix details of the amount of Product in Endo’s possession. 

  

	12.6	Termination by Endo due to Inability to Supply. Endo may terminate this Agreement with immediate effect by written notice to such effect to Vyrix should there be a Long Term Inability to Supply that persists for
six (6) months after the scheduled delivery of the goods as described in 6.5. 

  
 18 

	12.7	Sell-Off Period. Notwithstanding any termination of the Agreement (in whole or in respect of a particular country), Endo shall be entitled to continue to enjoy its rights and licenses and be entitled to continue
to sell existing inventory of the Product in the relevant country or countries for a further period of nine (9) months. 

  

	12.8	Stock Purchase. Subject to Section 12.4, Vyrix shall be entitled, at its option, exercisable by written notice to Endo within a period of thirty (30) days following the date of termination or expiration of
this Agreement, to repurchase from Endo any unsold Product. The repurchase price shall be the same price at which Vyrix originally sold such Product to Endo provided that Vyrix is responsible for arranging, and for the cost of, transport and
insurance arising from the repurchase. 

  

	12.9	Survival. Expiry or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, including the payment obligation specified in Section 9.9.
Without limiting the foregoing, Sections 3.3 and 3.4 and Sections 7 through 18 (both inclusive), shall survive the termination or expiry of this Agreement. 

  

	13.	WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY 

  

	13.1	Product Warranty. Vyrix warrants to Endo that: 

  

	 	(a)	Vyrix shall maintain in effect all required approvals regarding the Product and the manufacturing facility and, as the case may be, ensure that at all times such approvals remain valid with respect to any additional
manufacturing facility, including without limitation in both cases, the maintenance of GMPs with respect thereto. Vyrix shall manufacture, test, store and ship the Product in accordance with (i) the Specifications, (ii) applicable
law, including GMPs, and (iii) required approvals in France or the country in which the manufacturing site resides; 

  

	 	(b)	the Product delivered to Endo hereunder shall conform, in all material respects, to the Specifications; and 

  

	 	(c)	Endo’s remedy under the warranty under this Section 13.1 is for Vyrix to replace any Product found to be defective during the warranty period and returned to Vyrix in accordance with Section 8, except in
the case of bodily injury or death, in which case such remedies shall not be exhaustive and shall be subject to Section 13.4. Except for the warranty provided in this Section 13.1 and Section 11, Vyrix makes no other warranties,
whether express or implied, regarding the Product. 

  

	13.2	Qualifications. The warranty set out in Section 13.1 does not apply to any Product that (i) has had any identification markings removed or rendered illegible, or (ii) has been damaged by transportation,
storage or maintenance after delivery to Endo under temperature and other conditions that are contrary to Vyrix’s specifications, or (iii) has been the subject of misuse, accident or neglect, or from any other cause beyond
Vyrix’s reasonable control after the delivery of Product in accordance with Section 6.4, or (iv) has been used in a manner not in accordance with the instructions supplied by Vyrix or in a manner other than for which it was
intended as indicated in the Product label claims. 

  

	13.3	Endo’s Indemnity. Endo shall indemnify, defend, and hold harmless Vyrix and its officers, directors, employees, Affiliates, and agents and their respective successors, heirs and assigns (the “Vyrix
Indemnitees”), against any and all liability, damage, loss and expense, including reasonable attorneys’ fees and expenses of litigation, incurred by or imposed upon any of the Vyrix Indemnitees in connection with any claims, suits,
actions, demands or judgments 

  
 19 

 (the “Endo Indemnifying Claims”) arising out of any theory of
liability, including without limitation actions in the form of tort, warranty, or strict liability and regardless of whether such action has any factual basis, concerning Endo’s or its Affiliates’, distributors’, agents’ or
licensees’ exploitation or sale of the Product and/or the manufacture of Product, the marketing, offering for sale and sale, use and/or promotion, importation and export of the Product, except to the extent that any Endo Indemnifying Claims are
the result of Vyrix’s breach of Section 11.7 or Vyrix’s failure to comply with its obligations hereunder, gross negligence or wilful misconduct. 
  

	13.4	Vyrix’s Indemnity. Subject to the terms of this Agreement, Vyrix shall indemnify, defend, and hold harmless Endo and its officers, directors, employees, Affiliates, and agents and their respective
successors, heirs and assigns (the “Endo Indemnitees”), against any and all liability, damage, loss and expense, including reasonable attorneys’ fees and expenses of litigation, incurred by or imposed upon any of the
Endo Indemnitees in connection with any claims, suits, actions, demands or judgments (the “Vyrix Indemnifying Claims”) arising out of any theory of liability, including without limitation actions in the form of tort,
warranty, or strict liability and regardless of whether such action has any factual basis, concerning 

  

	 	(a)	Vyrix’s breach of the Section 11.1 warranty; 

  

	 	(b)	Vyrix’s breach of the Section 13 warranty; 

  

	 	(c)	Vyrix’s breach of any of its representations or warranties of this Agreement, or breach of any other provision of this Agreement by Vyrix; 

 

	 	(d)	any claim that the exercise by Endo of its rights under this Agreement relating (directly or indirectly) to Vyrix IP infringes the intellectual property of the other person; and 

 

	 	(e)	any claim that the use of the Product in conformity with the applicable marketing authorization has caused damage or loss to any person, 

except to the extent that any Vyrix Indemnifying Claims are the result of Endo’s failure to comply its obligations hereunder or its gross
negligence or wilful misconduct. 
  

	13.5	Notice. If a party receives notice of any Vyrix Indemnifying Claim or if Vyrix receives notice of any Endo Indemnifying Claim (each, an “Indemnifying Party”), the other party (the
“Indemnitee”) shall, as promptly as is reasonably possible, give the Indemnifying Party notice thereof; provided, however, that failure to give such notice promptly shall only relieve the Indemnifying Party of any indemnification
obligation hereunder to the extent such failure diminishes the ability of the Indemnifying Party to respond to or to defend the Indemnitee against such indemnifying claim of the Indemnifying Party. The parties shall consult and cooperate with each
other regarding the response to and the defense of any such indemnifying claim and the Indemnifying Party shall assume the defense or represent the interests of the Indemnitee in respect of such indemnifying claim of the Indemnifying Party, that
shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Indemnitee and to propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no such
settlement shall be made without the prior written consent of the Indemnitee, such consent not to be unreasonably withheld. Nothing herein shall prevent the Indemnitee from retaining its own counsel and participating in its own defence at its own
cost and expense. 

  
 20 

	13.6	Settlements. Neither party may settle a claim or action related to its indemnity obligations hereunder without the consent of the Indemnitee, if such settlement would impose any monetary obligation on the
Indemnitee or require the Indemnitee to submit to an injunction or otherwise limit the Indemnitee, its Affiliates, employees, agents, officers or directors; provided that this restriction shall not apply to any settlement by Vyrix of litigation
relating to the Vyrix IP. 

  

	13.7	Limitation of Liability. Subject only to Sections 7.1 and 7.2, neither party shall have any liability to the other party or its Affiliates for any loss of profits, direct, special, indirect, consequential,
exemplary, punitive or incidental damages arising out of or relating to this Agreement however caused and on any theory of liability (including negligence), whether or not a party has been advised of the possibility of such damages.

  

	13.8	Endo Insurance. Endo shall be responsible at its own cost to effect and maintain throughout the Term comprehensive and product liability insurance policy that a reasonable and prudent person engaged in the
relevant industry would effect and maintain, and including without limitation contractual liability coverage for Endo’s indemnification obligations hereunder. Such insurance policy shall be insurance cover of not less than CAD$5,000,000. Endo
shall deliver to Vyrix a copy thereof at Vyrix’s request. 

  

	13.9	Vyrix Insurance. Vyrix either directly or via its parent company Ampio Pharmaceuticals now has in effect and shall maintain in good standing throughout the Term, comprehensive civil and product liability
insurance with a single limit of USD$ 5,000,000 per loss and per insurance year aggregated, during the Term, from a reputable and financially secure insurance carrier, to cover any physical or material damage injury to third parties arising
under or related to Vyrix’s performance of its obligations under this Agreement. 

  

	14.	CONFIDENTIALITY 

  

	14.1	Confidential Information. “Confidential Information” means any scientific, technical, trade or business information or material related to a party’s (the “Discloser”)
technology or business that is the subject of efforts that are reasonable under the circumstances to maintain its secrecy, and is disclosed to the other party or to that other party’s Affiliates (collectively, the “Recipient”)
in connection with this Agreement. Without limiting the foregoing, a party’s Confidential Information includes information in which such party owns the intellectual property rights and interests in accordance with the terms herein. Confidential
Information does not include information that: (i) is now or subsequently becomes generally available to the public through no wrongful act or omission of Recipient; (ii) Recipient can demonstrate to have had rightfully in its possession
prior to disclosure to Recipient by Discloser; (iii) is independently developed by Recipient without use, directly or indirectly, of any Confidential Information of Discloser as can be demonstrated by Recipient; or (iv) Recipient
rightfully obtains from a third party (except such third parties who act for or on behalf of the Discloser) who has the unrestricted right to transfer or disclose it. 

 

	14.2	Non-Disclosure. Except as specifically authorized in this Agreement or as has otherwise been specifically authorized by Discloser in writing, Recipient shall not directly or indirectly reproduce, use, distribute,
disclose or otherwise disseminate the Discloser’s Confidential Information. If required by law, the Recipient may disclose the Discloser’s Confidential Information to a governmental authority or by order of a court of competent
jurisdiction, provided that: (i) such disclosure is subject to all applicable governmental or judicial protection available for like information; (ii) reasonable advance notice is given to the Discloser; and (iii) the Discloser is
provided with a reasonable opportunity to avail itself of legal process to prevent or minimize such disclosure. 

  
 21 

	14.3	Return of Information. Upon expiry or termination of this Agreement, or upon request by Discloser, Recipient shall promptly deliver to Discloser or at Recipient’s option destroy all Confidential Information
of Discloser and all embodiments and/or copies thereof then in its custody, control or possession and shall deliver within one (1) month after such expiration or termination or request a written statement to Discloser certifying such action.

  

	14.4	Disclosure to Employees and Consultants. Recipient agrees that access to Confidential Information will be limited to those employees and other authorized representatives and consultants of Recipient who
(i) need to know such Confidential Information in order to conduct their work in connection with the terms of this Agreement, and (ii) have signed agreements with Recipient obligating them to maintain the confidentiality of Confidential
Information disclosed to them and to take all reasonably necessary steps to ensure that the terms of this Agreement are not violated by them. 

  

	14.5	Press Releases and Other Disclosures. Neither party shall publish any information or make public disclosure of the terms of this Agreement without the consent of the other party, such consent not to be
unreasonably withheld (with failure to respond to any request for consent beyond one (1) week from the request to be deemed consent). Notwithstanding the foregoing, a party may disclose the terms of, or activities under, this Agreement:

  

	 	(a)	to the extent required by law or regulation or court order, or by the rules of any stock exchange on which the stock or shares of the party are listed; and 

 

	 	(b)	in confidence to its professional advisors, and its existing or potential investors, acquirers or merger partners. 

The parties agree that press releases relating to this Agreement shall be made upon the Effective Date by each of them. 

 

	15.	PHARMACOVIGILANCE 

  

	15.1	Appropriate Reporting of Adverse Events. The parties agree that appropriate reporting of adverse events and other safety data relating to the Product is critical. Specific details regarding the management of
information of adverse events, medical inquiries and Product complaints related to the use of the Product in the Territory and outside will be set out in a separate document, to be agreed to by the parties at least three (3) months before the
first scheduled launch date in the Territory. The Pharmacovigilance and product labelling representatives of each party will work in good faith together to develop a document that identifies and/or provides: 

 

	 	(a)	which safety information will be exchanged; 

  

	 	(b)	when such information will be exchanged; 

  

	 	(c)	Endo will have regulatory reporting responsibilities; 

  

	 	(d)	Endo will manage the safety database for the Territory only; 

  

	 	(e)	Endo will be obligated to obtain follow-up information on incomplete safety reports for the Territory only; 

  
 22 

	 	(f)	that Endo will review the literature for safety report information for the Territory only; 

  

	 	(g)	that Endo will prepare required periodic safety updates for the Territory only; and 

  

	 	(h)	the identification of any other details required to appropriately manage safety information for the Product. 

  

	15.2	Quality and Pharmacovigilance Agreements. Within ninety (90) days after Regulatory Approval in Canada, the parties will begin to negotiate in good faith a mutually acceptable quality agreement and
pharmacovigilance agreement with respect to the Product including the matters set forth in Section 15.1 above. 

  

	16.	DISPUTE RESOLUTION 

  

	16.1	Conditions Prior to Litigation A party must not start arbitration or court proceedings (except proceedings seeking interlocutory relief) in respect of a Dispute unless it has complied with this clause.

  

	16.2	Dispute. For the purpose of this Section 16, “Dispute” means any dispute or material difference arising out of or in connection with this Agreement, between the parties. 

 

	16.3	No Court Proceedings. No party may commence or initiate any court proceedings (except applications for urgent interim injunctive relief) until the procedures set out below have been followed. 

 

	16.4	Notice of Dispute. A party that considers a Dispute has arisen or exists shall be entitled to send written notice to the other party involved in the Dispute (the “Dispute Notice”) setting
out a full description of the matters in dispute. 

  

	16.5	Dispute Resolution. Any Dispute between the parties shall be brought to the attention of the managing directors (or equivalent of each party) who shall attempt in good faith to achieve a resolution. If any
Dispute is not resolved by the parties’ managing directors (or their designees, as the case may be) within four (4) weeks after such dispute is referred to them, then either party shall have the right to refer such dispute to mediation,
provided that in the case of a dispute which primarily relates to the ownership or infringement of intellectual rights or issues relating to the supply of the Product by Vyrix, the parties shall be entitled to commence litigation in a court of
competent jurisdiction after the expiry of such four (4) weeks. 

  

	16.6	Mediation. A Dispute which is not resolved in accordance with Section 16.5 shall be submitted by the parties to non-binding mediation following a process to be agreed upon by the parties. 

 

	16.7	Failure of Mediation. If the parties do not resolve the Dispute by mediation within a period of ninety (90) days after the case has been referred to mediation either party may enter the dispute in any court
having jurisdiction. 

  

	16.8	Costs. The expenses of mediation and/or litigation shall be borne by the parties in such proportion as determined by the mediator or otherwise in such proportion to which each party is defeated or prevails in
litigation.  

  
 23 

	16.9	If a party does not comply with any provision of Sections 16.1 to 16.6, the other party involved in the Dispute will not be bound by Sections 16.1 to 16.6. 

 

	17.	FORCE MAJEURE 

  

	17.1	Failure Due to Force Majeure. Notwithstanding anything to the contrary in this Agreement, no party is responsible or liable to the other party for, nor will this Agreement be terminated (except as provided under
Section 17.5) as a result of that first mentioned party’s failure to perform any of its obligations hereunder, with the exception of payment of monies due and owing, if such failure results from Force Majeure. 

 

	17.2	Exceptions. A party is not entitled to the benefit of the provisions of Section 17.1 under any of the following circumstances: 

 

	 	(a)	to the extent that the failure was caused by the contributory negligence of that party; 

  

	 	(b)	to the extent that the failure was caused by that party having failed to take reasonable steps to remedy the condition and to resume the performance of such obligations as soon as practicable; 

 

	 	(c)	unless as soon as possible after the occurrence relied upon or as soon as possible after determining that the occurrence was in the nature of Force Majeure and would affect that party’s ability to observe and
perform its obligations contained in this Agreement that party has given to the other party written notice that the former party is unable by reason of Force Majeure (the nature of which must be specified therein) to perform the particular
obligations. 

  

	17.3	Avoidance of Force Majeure. The party claiming Force Majeure shall use reasonable efforts to avoid or remove any such causes and resume performance under this Agreement as soon as feasible whenever such cause is
removed, provided however that the foregoing is not to be construed to require a party to settle any labour dispute or to commence, continue or settle any litigation. 

 

	17.4	Notice of Force Majeure. The party claiming Force Majeure shall likewise give notice as soon as possible after the Force Majeure condition has been remedied or ceased to exist to the effect that the same has been
remedied and that the party has resumed or is then in a position to resume the performance of such obligations. 

  

	17.5	Termination for Force Majeure. If the cause of the delay continues for a period of more than ninety (90) days the party not claiming Force Majeure may terminate this Agreement by written notice to the other
party without penalty. 

  
 24 

	18.	GENERAL 

  

	18.1	Notices. Any consent, notice or report required or permitted to be given or made under this Agreement by one of the parties to the other shall be in writing (by registered mail or facsimile or e-mail
message) and addressed to such other party at its address indicated above, or to such other address as the addressee shall have last furnished in writing to the addressor, and shall be effective upon receipt by the addressee. If to Endo, a
copy should be sent to: 

 ENDO VENTURES LIMITED. 

No. 33 Fitzwilliam Square 

Dublin 2 

Ireland 
 If to
Vyrix, a copy should be sent to: 
 Vyrix Pharmaceuticals, Inc. 

5445 DTC Parkway 

Suite 925 

Greenwood Village, CO 80111 
  

	18.2	Waiver. A waiver by any party of any breach or a failure to enforce or to insist upon the observance of a condition of this Agreement will not be a waiver of any other or of any subsequent breach. No waiver under
this agreement will be binding unless in writing and signed by the parties giving the waiver. 

  

	18.3	Severance. If any part of this Agreement is invalid, unenforceable, illegal, void or voidable for any reason, this Agreement will be construed and be binding on the parties as if the invalid, unenforceable,
illegal, void or voidable part had been deleted from this Agreement or read down to the extent necessary to overcome the difficulty. 

  

	18.4	Successors and Assigns. This Agreement will be binding on and continue for the benefit of each party, its successors and permitted assigns. 

 

	18.5	Further Assurances. The parties will do everything reasonably necessary to give effect to this Agreement and to the transactions contemplated by it and will use all reasonable endeavours to cause relevant third
parties to do likewise. 

  

	18.6	Assignment. Neither party may assign any of its rights or obligations under this Agreement without first obtaining the other party’s advance written consent to such effect, except that either party may do so
as part of a corporate restructure and either Party may assign this Agreement to an Affiliate, in either case without having to obtain the other party’s advance written consent. 

 

	18.7	Continuing Obligations. The expiration or termination of this Agreement does not operate to terminate any of the continuing obligations under this Agreement and they will remain in full force and effect and
binding on the party concerned. 

  
 25 

	18.8	Variation. No variation of this Agreement (other than a waiver which is governed by Section 18.2) will be binding on the parties unless in writing and signed by all parties. 

 

	18.9	Applicable Law. This Agreement is governed by and construed in accordance with the laws of the Courts of New York State, USA. 

 

	18.10	No Agency. Nothing contained in this Agreement shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between the parties. Neither party shall at any time enter
into, incur or hold itself out to third parties as having authority to enter into, or incur, any commitment, expense or liability on behalf of the other party. All contracts, undertakings, expenses and liabilities undertaken or incurred by one party
in the performance of this Agreement shall be undertaken or incurred exclusively by that party and not as an agent or representative of the other party. 

  

	18.11	Costs. Each party shall pay their own legal, accounting and other costs in relation to the negotiation, preparation, execution and implementation of this Agreement. 

 

	18.12	Entire Agreement. This Agreement (including the schedules) constitutes the entire agreement and basis of the transaction between the parties in relation to its subject matter and supersedes all other
communications, negotiations, arrangements and agreements between Vyrix and Endo, whether oral or in writing including, as from the Effective Date in relation to the subject matter of this Agreement, the confidentiality agreement dated 24 July
2013 between Vyrix and Endo (which confidentiality agreement remains in full force and effect in relation to any other subject matter covered by this confidentiality agreement and in relation to any breach of that confidentiality agreement in
relation to the subject matter of this Agreement occurring on or prior to the Effective Date). 

 AND THE PARTIES HAVE SIGNED: 

 

									
	VYRIX PHARMACEUTICALS, INC.	 		 	ENDO VENTURES LIMITED
					
	By:	 	 /s/ Jarrett T. Disbrow
	 		 	By:	 	 /s/ Blaine T. Davis

	 Name:
 Title:
	 	 Jarrett T. Disbrow
 President &
CEO
	 		 	 Name:
 Title:
	 	 Blaine T. Davis
 President

					
	By:	 	  
	 		 		 	
	 Name:
 Title:
	 		 		 		 	

  
 26 

 Schedule 1 

To the Distribution and License Agreement between Vyrix and Endo 

Product Specifications 

Release Specifications for Tramadol 89 mg Drug Product 

(Australia – Commercial Product) 
  

											
	 Test
	  	Method	 	Specification
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
		  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
		  	 				 	 	 	[	...***...] 
		  	 				 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 	 	[	...***...] 	 	 	 	[	...***...] 
	 [...***...]
	  	 				 	 			

 Schedule 2 

To the Distribution and License Agreement between Vyrix and Endo 

Intellectual Property 

Licensed Patents 
  

											
	 Country
	  	 Title
	  	Patent #	 	  	Issue Date	 
	 Canada
	  	Use of Tramadol to Delay Ejaculation	  	 	2,440,920	  	  	 	1/24/2012	  
	 Mexico
	  	Method of Delaying Ejaculation	  	 	244522	  	  	 	3/28/2007	  
	 South Africa
	  	Method of Delaying Ejaculation	  	 	2003/08067	  	  	 	3/30/2005	  

 Licensed Trademarks 

ZERTANE 

 Schedule 3 

Definition of Sub Saharan Africa and Latin America 

Sub Saharan Africa shall mean the following countries: Angola, Botswana, Cameroon, DR Congo, Gabon, Kenya, Lesotto, Madagascar, Malawi, Mozambique,
Mierz, Nigeria, Swaziland, Uganda, Zimbabwe, Tanzania 
 Latin America shall mean the following countries: Antigua and Barbuda, Aruba, Bahamas,
Barbados, Belize, Bermuda, British Virgin Islands, Cayman Islands, Costa Rica, Curacao, Dominica, Dominican Republic, El Salvador, Grenada, Guadeloupe, Guatemala, Haiti, Honduras, Jamaica, Martinique, Mexico, Monserrat, Nicaragua, Panama, Saint
Lucia, Saint Vincent and the Grenadines, Trinidad & Tobago, Turks & Caicos.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00229-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00229-of-00352.parquet"}]]