UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K/A

(Amendment No. 1)

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): April 16, 2015

 

 

ROSEWIND CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Colorado   000-53121   47-0883144

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

373 Inverness Parkway

Suite 200

Englewood, Colorado

  80112
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (720) 437-6500

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01. Other Events.

Rosewind Corporation is filing this Current Report on Form 8-K/A solely for the purpose of filing Exhibits 10.4, 10.5, 10.7, 10.8, 10.9 and 10.10, which exhibits were described in the Current Report on Form 8-K filed by Rosewind Corporation with the Securities and Exchange Commission on April 22, 2015.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits . Reference is made to the Exhibit Index following the signature page of this Current Report on Form 8-K/A, which is incorporated herein by reference.

 

1


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

ROSEWIND CORPORATION
Date: June 8, 2015 By: /s/ Gregory A. Gould
Gregory A. Gould
Chief Financial Officer


EXHIBIT INDEX

 

E XHIBIT  N O .   

D ESCRIPTION OF E XHIBIT

2.1 *    Agreement and Plan of Merger among Rosewind, Luoxis, Vyrix, two major stockholders of Rosewind and two subsidiaries of Rosewind, dated as of April 16, 2015
2.2 *    Certificate of Merger
3.1 *    Articles of Incorporation, as amended
3.2 *    Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Form SB-2/A filed March 7, 2007; File No. 333-139933)
10.1†*    Form of Indemnification Agreement, to be entered into between the Registrant and its directors and officers
10.2†*    Employment Agreement between Registrant and Joshua R. Disbrow, dated as of April 16, 2015
10.3†*    Employment Agreement between Registrant and Jarrett Disbrow, dated as of April 16, 2015
10.4#    Asset Purchase Agreement between the Registrant (as assigned to it by Ampio/Vyrix) and Valeant International (Barbados) SRL, effective as of December 2, 2011
10.5#    Manufacturing and Supply Agreement between the Registrant (as assigned to it by Ampio/Vyrix) and Ethypharm S.A., dated September 10, 2012
10.6 *    License, Development and Commercialization Agreement between the Registrant (as assigned to it by Ampio/Vyrix) and Daewoong Pharmaceuticals Co., Ltd., effective as of August 23, 2011 (incorporated by reference to Exhibit 10.1 to Ampio’s Form 8-K/A filed October 5, 2011; File No. 001-35182)
10.7#    Distribution Agreement between the Registrant (as assigned to it by Ampio/Vyrix) and FBM Industria Farmaceutica, Ltda., dated as of March 1, 2012
10.8#    Distribution and License Agreement between the Registrant (as assigned to it by Ampio/Vyrix) and Endo Ventures Limited, dated April 9, 2014
10.9#    Sponsored Research Agreement between the Registrant (as assigned to it by Ampio/Luoxis) and Trauma Research LLC, dated September 1, 2009
10.10#    Addendum No. 4 to Sponsor Research Agreement between the Registrant (as assigned to it by Ampio/Luoxis) and Trauma Research LLC, dated March 17, 2014
10.11 *    Promissory Note issued by Ampio to the Registrant on April 16, 2015
10.12 *    Subscription Agreement between the Registrant and Ampio, dated April 16, 2015
10.13 *    Voting Agreement between the Registrant and Ampio, dated April 22, 2015 (incorporated by reference to Exhibit 10.1 to Ampio’s Form 8-K filed April 22, 2015; File No. 001-35182)
16.1 *    Letter from HJ & Associates, LLC, dated April 21, 2015
99.1 *    Audited Combined Financial Statements of Vyrix and Luoxis, for the fiscal years ended December 31, 2014 and 2013
99.2 *    Pro Forma Financial Information giving effect to the acquisition of Vyrix and Luoxis
99.3 *    Press Release issued by the Registrant on April 16, 2015

 

* Previously filed.


# Application has been made to the Securities and Exchange Commission for confidential treatment of certain provisions. Omitted material for which confidential treatment has been requested has been filed separately with the Securities and Exchange Commission.
Indicates a management contract or any compensatory plan, contract or arrangement.

Exhibit 10.4

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Execution Copy

ASSET PURCHASE AGREEMENT

This Asset Purchase Agreement (“ Agreement ”) is entered into by and between Ampio Pharmaceuticals, Inc., a Delaware corporation, with its principal place of business at 5445 DTC Parkway, Suite 925, Greenwood Village, Colorado 80111, USA (“ Ampio ”), and Valeant International (Barbados) SRL (formerly Biovail Laboratories International SRL), a society with restricted liability established under the laws of Barbados, with its principal place of business at Welches, Christ Church, Barbados, West Indies (“ VIB ”), as of December 2, 2011 (the “ Effective Date ”).

RECITALS

WHEREAS, DMI BioSciences, Inc. (“ DMI ”), a wholly-owned subsidiary of Ampio, and VIB were parties to a certain License and Development Agreement dated August 7, 2007, as amended (the “ DMI-VIB License Agreement ”) concerning, in part, the development and commercialization of tramadol for the treatment of premature ejaculation; and

WHEREAS, VIB has terminated the DMI-VIB License Agreement with DMI; and

WHEREAS, VIB is a party to a certain NDA Assignment and License Agreement by and between VIB and Ethypharm, a societe anonyme organized under the laws of France with its principal place of business at 194 Bureaux de la Colline, 92213 Saint-Cloud, France (“ Ethypharm ”), dated February 6, 2009 (the “ NDA Agreement ”); and

WHEREAS, VIB has certain rights in and to the Tramadol Product (as defined below); and

WHEREAS, Ampio wishes to have the NDA Agreement assigned to it and wishes to acquire VIB’s rights to the Tramadol Product and VIB is willing to assign the NDA Agreement to Ampio and sell to Ampio its rights to the Tramadol Product, all on the terms set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows.


ARTICLE 1

DEFINITIONS AND INTERPRETATION

1.1 Definitions . Capitalized terms and phrases used herein and not otherwise defined or modified hereinbelow shall have the respective meanings ascribed thereto in the Agreement.

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.

Additional Consideration ” has the meaning set forth in Section 3.2 herein.

Affiliate ” of any Person means, at the time such determination is being made, any other Person Controlling, Controlled by or under common Control with such first Person, in each case, whether directly or indirectly. For the purposes of this definition, a Person will be deemed to “Control” another Person if such first Person has (a) direct or indirect ownership of more than fifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to vote on or direct the affairs of such other Person, or (b) the power, directly or indirectly, to direct or cause the direction of the policies and management of the other Person, whether by the ownership of stock, by contract, or otherwise.

Agreement ” has the meaning set forth in the first paragraph above.

Ampio ” has the meaning set forth in the first paragraph above.

Ampio Closing Certificate ” has the meaning set forth in Section 4.3.2 herein.

Ampio Closing Deliverables ” has the meaning set forth in Section 4.3 herein.

Ampio Indemnified Parties ” has the meaning set forth in Section 8.2 herein.

Ampio Product ” means the oral rapid dissolve tablet formulation of the Active Ingredient, whether as the only active pharmaceutical ingredient or in combination with other active pharmaceutical ingredients, with an indication outside of the field of pain.

Applicable Law ” means applicable law (including common law and civil law), statutes, by-laws, rules, regulations, Orders, ordinances, protocols, codes, guidelines, treaties, policies, notices, directions, decrees, judgments, awards or requirements, in each case of any Governmental Entity.

Assumed Liabilities ” has the meaning set forth in Section 2.3 herein.

Assumption Agreement ” means an assumption agreement to be entered into by Ampio and VIB at Closing, substantially in the form of Exhibit A .

Bill of Sale ” means a bill of sale and assignment to be entered into by Ampio and VIB at Closing, substantially in the form of Exhibit B .

 

2


Business Day ” means any day other than a Saturday, Sunday or other day on which banks in the State of Colorado or in Barbados are permitted or required to close by any Applicable Law.

Calendar Quarter ” means the three-month period commencing January 1, April 1, July 1 or October 1.

Closing ” has the meaning set forth in Section 4.1 herein.

Closing Date ” has the meaning set forth in Section 4.1 herein.

Closing Time ” has the meaning set forth in Section 4.1 herein.

Contract Assignment and Assumption Agreement ” means the Contract Assignment and Assumption Agreement to be entered into by Ampio and VIB at Closing, with respect to the assignment by VIB, and assumption by Ampio, of the NDA Agreement, substantially in the form of Exhibit C .

Control ” or “ Controlled ” means that a right is owned, licensed, or otherwise possessed by a Party with the right to license or sub-license without consent.

DMI ” has the meaning set forth in the Recitals above.

DMI-VIB License Agreement” has the meaning set forth in the Recitals above.

Effective Date ” has the meaning set forth in the first paragraph above.

Ethypharm ” has the meaning set forth in the Recitals.

Ethypharm Consent ” has the meaning set forth in Section 4.4.3 herein.

Excluded Assets ” has the meaning set forth in Section 2.2 herein.

Governmental Entity ” means governments, regulatory authorities, governmental departments, agencies, agents, commissions, bureaus, officials, ministers, Crown corporations, courts, bodies, boards, tribunals or dispute settlement panels or other law, rule or regulation-making organizations or entities.

Indemnified Party ” has the meaning set forth in Section 8.4.1 herein.

Indemnifying Party ” has the meaning set forth in Section 8.4.1 herein.

Initial Consideration ” has the meaning set forth in Section 3.1 herein.

Know-How ” means scientific, medical, technical, clinical, regulatory, manufacturing, trade and marketing information, data and materials, and trade secrets.

Liabilities ” means any and all debts, liabilities and obligations, whether accrued or fixed, absolute or contingent, matured or unmatured, or determined or determinable, including those arising under any law, action or governmental order and those arising under any contract, agreement, arrangement, commitment or undertaking, or otherwise.

 

3


Losses ” means, collectively, any and all damages, losses, taxes, Liabilities, claims, judgments, penalties, costs and expenses (including reasonable attorneys’ fees and litigation expenses).

NDA Agreement ” has the meaning set forth in the Recitals above.

Net Sales ” means the amount of gross sales of Ampio Products in the Territory for a specified period sold by Ampio, its Affiliates or licensees or subcontractors to Third Parties less the following items as applicable to the Ampio Products, all in accordance with standard allocation procedures, allowance methodologies and accounting methods consistently applied in accordance with U.S. Generally Accepted Accounting Principles (“ US GAAP ”):

 

  (i) credits or allowances actually granted for damaged products, returns or rejections of product, price adjustments and billing errors;

 

  (ii) governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, provincial, local and other governments, their agencies and purchasers, and reimbursers or to trade customers;

 

  (iii) normal and customary trade, cash and quantity discounts, allowances and credits;

 

  (iv) transportation costs, including insurance, for outbound freight related to delivery of the product to the extent included in the gross amount invoiced; and

 

  (v) sales taxes, value added taxes and other taxes directly applied to the sale of the product to the extent included in the gross amount invoiced.

In no event shall any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). Sales of Ampio Product between Ampio and its Affiliates or licensees or subcontractors for resale shall be excluded from the computation of Net Sales, but the subsequent resale of such Ampio Product to a Third Party shall be included within the computation of Net Sales.

Party ” means either VIB or Ampio and “Parties” means both VIB and Ampio.

Person ” means any individual, sole proprietorship, partnership, firm, entity, unincorporated association, unincorporated syndicate, unincorporated organization, trust, body corporate, Governmental Entity, and where the context requires any of the foregoing when they are acting as trustee, executor, administrator or other legal representative.

Product Liability Claims ” means any product liability claims asserted or filed by Third Parties (without regard to their merit or lack thereof), seeking damages or equitable relief of any kind, relating to personal injury, wrongful death, medical expenses, an alleged need for medical monitoring, consumer fraud or other alleged economic losses, allegedly caused by the Ampio Product, and including claims by or on behalf of users of the Ampio Product (including spouses, family members and personal representatives of such users) relating to the use, sale, distribution or purchase of the Ampio Product sold by or on behalf of Ampio or its Affiliates, distributors or licensees.

 

4


Purchased Assets ” means all of VIB’s rights, title and interest in (i) the NDA Agreement, (ii) the Tramadol Know-How, and (iii) the Samples.

Retained Liabilities ” has the meaning set forth in Section 2.4 herein.

Samples ” means the tablets of [***] of the Tramadol Product used by VIB or its Affiliates in those [***] studies known to VIB as [***], in the amounts set out in and as otherwise described in the disposition reports attached as Schedule A to the Technology Transfer Plan.

Technology Transfer Plan ” means the technology transfer plan attached hereto as Exhibit E.

Territory ” means worldwide.

Third Party ” means any Person other than VIB or Ampio or their respective Affiliates.

Third Party Claim ” has the meaning set forth in Section 8.4.2 herein.

Tramadol Know-How ” means the Know-How Controlled by VIB as of the Closing Date (for purposes of clarity, including Affiliates of VIB) relating to the Tramadol Product, which Know-How is set out on the Technology Transfer Plan (including Tramadol Know-How identified as “essential” and “non-essential”), and all of VIB’s rights thereto.

Tramadol Product ” means the oral rapid dissolve tablet formulation of the Active Ingredient [***] developed by VIB for use in the indication of premature ejaculation.

Transaction Documents ” means: (i) the Assumption Agreement; (ii) the Contract Assignment and Assumption Agreement; (iii) the Bill of Sale; and (iv) other documents contemplated hereby and thereby.

US GAAP ” has the meaning set forth in the definition of “Net Sales” in Section 1.1 herein.

VIB ” has the meaning set forth in the first paragraph above.

VIB Closing Certificate ” has the meaning set forth in Section 4.4.2 herein.

VIB Closing Deliverables ” has the meaning set forth in Section 4.4 herein.

VIB Indemnified Parties ” has the meaning set forth in Section 8.3 herein.

 

 

* Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.

 

5


1.2 Interpretation .

 

1.2.1 Including . When used in this Agreement, the words “include”, “includes” and “including” shall be deemed to be followed by the words “without limitation.”

 

1.2.2 Number . Any terms defined in the singular shall have a comparable meaning when used in the plural, and vice-versa.

 

1.2.3 Section References, Etc . All references to any introductory paragraph, recitals, Articles, Sections and Exhibits shall be deemed references to the introductory paragraph, recitals, Articles, Sections and Exhibits to this Agreement.

 

1.2.4 Gender . A reference to one gender shall include any other gender.

 

1.2.5 Headings . Headings of Articles and Sections are inserted for convenience of reference only and do not affect the construction or interpretation of this Agreement.

 

1.2.6 No Strict Construction . The language used in this Agreement is the language chosen by the Parties to express their mutual intent, and no rule of strict construction shall be applied against any Party.

 

1.2.7 Statutes . A reference to a statute includes all regulations and rules made pursuant to such statute and, unless otherwise specified, the provisions of any statute, regulation or rule which amends, supplements or supersedes any such statute, regulation or rule.

 

1.2.8 Time Periods . Unless otherwise specified, time periods within or following which any payment is to be made or act is to be done shall be calculated by excluding the day on which the period commences and including the day on which the period ends and by extending the period to the next Business Day following if the last day of the period is not a Business Day.

1.3     Currency . All currency amounts referred to in this Agreement are in United States Dollars unless otherwise specified.

ARTICLE 2

PURCHASE AND SALE

2.1     Sale of the Purchased Assets . Subject to the provisions of this Agreement, VIB shall, on the Closing Date, sell, assign, convey, transfer and deliver to Ampio, and Ampio shall purchase, acquire and accept, all right, title and interest of VIB in the Purchased Assets.

2.2     Excluded Assets . Purchaser and Seller expressly agree and acknowledge that the Purchased Assets shall not include any other asset, property or right of Seller not referenced in the definition of “Purchased Assets” set forth in Section 1.1 (collectively, the “ Excluded Assets ”).

 

6


2.3     Assumption of Certain Liabilities and Obligations . As of the Closing Date, Ampio shall assume control of, and responsibility for, all costs, obligations and Liabilities arising from or related to the Purchased Assets that relate to the period on or following the Closing (“ Assumed Liabilities ”). For greater certainty, the Assumed Liabilities shall include all of VIB’s liabilities and obligations under the NDA Agreement and Ampio agrees to be responsible for the full performance and discharge of all of VIB’s obligations, duties and responsibilities under the NDA Agreement, in each case arising from and after the Closing Date.

2.4     Retained Liabilities . VIB shall retain and shall be fully responsible for all costs, obligations and Liabilities arising from or related to (i) the Purchased Assets that relate to the period prior to the Closing, (ii) the Samples and Tramadol Know-How until such time they are transferred to Ampio, and (iii) the Excluded Assets (collectively, the “ Retained Liabilities ”). For greater certainty, the Retained Liabilities shall include any Liabilities and obligations of VIB under the NDA Agreement that relate to the period prior to the Closing Date, regardless of when such Liabilities arise.

2.5     Assignment and Assumption of the NDA Agreement . As of the Closing Date and subject to receipt of the Ethypharm consent, VIB shall assign and Ampio shall assume the NDA Agreement; provided however that Ampio shall assume only those Liabilities and obligations under the NDA Agreement that relate to the period commencing on the Closing Date. The Parties agree and acknowledge that the assignment of the NDA Agreement requires the consent of Ethypharm and that the receipt of such Ethypharm Consent is a condition of Closing that must be waived by both Parties for the Closing to occur if such Ethypharm Consent is not received from Ethypharm. Ampio shall assist and cooperate with VIB in connection with the obtaining of the Ethypharm Consent. The Parties acknowledge and agree that neither Party shall be required to pay money to Ethypharm or any other Person, commence litigation or offer or grant any accommodation (financial or otherwise) to Ethypharm or any other Person in connection with such efforts.

2.6     Samples . The Samples, which form part of the Purchased Assets, shall be sold and transferred to Ampio on an “as is, where is” basis and VIB shall provide no representations or warranties with respect to the Samples, including as to fitness for use, except as specifically set forth herein.

ARTICLE 3

PURCHASE PRICE

3.1     Initial Consideration . As consideration, in part, for the Purchased Assets, Ampio shall pay to VIB, in the aggregate, Two Million US Dollars (US$2,000,000) (the “ Initial Consideration ”), which amount shall be non-refundable and non-creditable against other payments due under this Agreement and which amount shall be payable within five (5) calendar days of the date on which VIB has completed the transfer to Ampio of the Samples and the Tramadol Know-How identified as “essential” in the Technology Transfer Plan, in accordance with the terms of this Agreement.

 

7


3.2     Additional Consideration . As additional consideration for the Purchased Assets, Ampio shall pay to VIB additional amounts equal to [***] of the aggregate annual Net Sales of any Ampio Product (the “ Additional Consideration ”). The Additional Consideration shall be paid on a quarterly basis, within thirty (30) days of the end of the applicable Calendar Quarter. Within thirty (30) days after the end of each Calendar Quarter during which there are Net Sales, Ampio shall deliver a report to VIB specifying the Net Sales of the Ampio Product for the applicable Calendar Quarter. Together with the delivery of such report, Ampio shall pay to VIB the Additional Consideration applicable to such Calendar Quarter.

3.3     Transfer Taxes and Withholding . Despite any other provision contained in this Agreement to the contrary, in respect of the purchase and sale of the Purchased Assets under this Agreement, each Party shall pay direct to the appropriate Governmental Entity all sales and transfer taxes, registration charges and transfer fees payable by it. All taxes levied on account of the payments accruing to VIB under this Agreement shall be paid by VIB for its own account, including taxes levied thereon as income to VIB. If Applicable Law requires that taxes be deducted and withheld from a payment, the remitting Party shall (i) deduct those taxes from the payment; (ii) pay the taxes to the proper taxing authority; (iii) send evidence of the obligation together with proof of payment to the other Party within sixty (60) days following that payment; and (iv) shall provide such assistance as the other Party may reasonably require in obtaining any refund of such amounts to which the other Party may be entitled, to the extent that such assistance does not cause the remitting Party to incur any liability in respect of the taxes asserted to be due.

3.4     Mode of Payment . Each Party shall pay all amounts due under this Agreement in US funds by bank wire transfer in immediately available funds to such bank as the other may direct in writing from time to time.

3.5     Late Payments . In the event that any uncontested payment due under this Agreement is not made when due, the payment shall accrue interest from the date due at a rate per annum equal to four per cent (4%) above the U.S. Prime Rate (as set forth in the Wall Street Journal, Eastern Edition) for the date on which payment was due, calculated daily on the basis of a 365-day year, or similar reputable data source; provided that, in no event shall such rate exceed the maximum interest rate allowable under Applicable Law.

3.6     Records . Ampio shall keep, and require its Affiliates, licensees and distributors to keep, a true and accurate account of the Ampio Product distributed or sold in the Territory. Such books and records shall be kept for such period of time required by Applicable Law, but no less than at least three (3) years following the end of the Calendar Quarter to which they pertain.

 

3.7 Audit Rights .

 

3.7.1 VIB shall have the right, through a certified public accountant or like person reasonably acceptable to Ampio, upon execution of a reasonable confidentiality agreement, to examine the records of Ampio, or its Affiliates or, if Ampio has the right, its licensees or

 

 

* Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.

 

8


subcontractors, during regular business hours upon reasonable notice and for one (1) calendar year after its termination; provided, however, that: (a) such examination shall not take place more often than once a calendar year and shall not cover such records for more than the preceding calendar year, and (b) such accountant shall report to VIB only as to the accuracy of the reports or payments of Additional Consideration provided or made by Ampio under this Agreement. The accountant shall send a copy of the report to Ampio at the same time it is sent to VIB.

3.7.2     In negotiating any agreements or contracts with its licensees and subcontractors of Ampio Products hereunder, Ampio shall use its commercially reasonable efforts to include a provision permitting VIB to conduct an audit of each such licensee or subcontractor in the manner described in Section 3.7.1 above. If Ampio is unable to successfully negotiate the inclusion of such a provision, then Ampio agrees that, on request from VIB, it will conduct an audit, in accordance with the terms of Ampio’s contract or agreement with such licensee or subcontractor, of such licensee’s or subcontractor’s books and records to the extent they relate to the sale of an Ampio Product and shall provide the results of such audit to VIB, to the extent permitted under the terms of any such contract or agreement with such licensee or subcontractor.

3.7.3     Inspections conducted under this Section 3.7 shall be at the expense of VIB, unless a variation or error producing an underpayment in amounts payable by Ampio to VIB as Additional Consideration exceeding an amount equal to five per cent (5%) of the amount paid for a period covered by the inspection is established, in which case all reasonable costs relating to the inspection for such period and any unpaid amounts that are discovered shall be paid by Ampio.

ARTICLE 4

THE CLOSING

4.1     Closing Date . Upon the terms and subject to the conditions of this Agreement, the closing of the Agreement and the transfer of the Purchased Assets and rights pursuant to this Agreement (the “ Closing ”) shall be held at 8:00 a.m. (ET) or such other time as the Parties may mutually agree in writing (the “ Closing Time ”) on the second (2 nd ) Business Day immediately following the receipt of the Ethypharm Consent executed on behalf of Ethypharm, or such other date as the Parties may mutually agree in writing (the “ Closing Date ”). Notwithstanding the foregoing, the Closing shall be deemed to occur at 12:01 a.m. ET on the Closing Date.

4.2     Place of Closing . The Closing shall take place at the offices of VIB located at Welches, Christ Church, Barbados, or at such other place or method as may be agreed upon by the Parties.

4.3     Closing Deliverables by Ampio . At the Closing, subject to the terms and conditions set forth herein, Ampio shall do or otherwise cause each of the following to occur (collectively, the “ Ampio Closing Deliverables ”):

 

4.3.1 Deliver to VIB duly executed copies of the Transaction Documents to which it is a party; and

 

9


4.3.2 Deliver to VIB a certificate executed by a duly authorized officer of Ampio dated the Closing Date, certifying that the representations and warranties of Ampio set forth in this Agreement and the Transaction Documents are true and correct in all material respects as of the Closing Date, except to the extent such representations and warranties relate to an earlier date (in which case such representations and warranties will be true and correct as of such earlier date) (the “ Ampio Closing Certificate ”).

4.4     Closing Deliverables by VIB . At the Closing, subject to the terms and conditions set forth herein, VIB shall do or otherwise cause each of the following to occur (collectively, the “ VIB Closing Deliverables ”):

 

4.4.1 Deliver to Ampio duly executed copies of the Transaction Documents to which it is a party;

 

4.4.2 Deliver to Ampio a certificate executed by a duly authorized officer of VIB dated the Closing Date, certifying that the representations and warranties of VIB set forth in this Agreement and the Transaction Documents are true and correct in all material respects as of the Closing Date, except to the extent such representations and warranties relate to an earlier date (in which case such representations and warranties will be true and correct as of such earlier date) (the “ VIB Closing Certificate ”); and

 

4.4.3 Deliver to Ampio a duly executed consent from Ethypharm to the assignment by VIB to Ampio of the NDA Agreement, in a form substantially similar to the consent attached hereto as Exhibit D (the “ Ethypharm Consent ”).

ARTICLE 5

COVENANTS

5.1     Further Assurances . VIB hereby agrees that it will promptly do all such acts and execute all such further documents, conveyances, deeds, assignments, transfers, licenses, and the like, and will cause the doing of all such acts on its own behalf and by each of its Affiliates and will cause the execution of all such further documents on its own behalf and by each of its Affiliates as are within its power as Ampio may from time to time reasonably request be done and/or executed in order to consummate the transactions contemplated under this Agreement, as may be necessary or desirable to effect the purposes of this Agreement, or as may be appropriate to more effectively carry out and vest in Ampio the grant of rights and licenses intended to be made under this Agreement.

5.2     Technology Transfer . No later than sixty (60) days after the Closing Date, VIB shall use commercially reasonable efforts to make available to Ampio the Tramadol Know-How (or copies thereof) identified as “essential” in the Technology Transfer Plan. The Parties agree that, if VIB is unable to make available to Ampio all of the Tramadol Know-How identified as “essential” in the Technology Transfer Plan within such sixty (60) day period, then the Parties shall meet to discuss, in good faith, alternate arrangements for the transfer of such Tramadol Know-How. In addition, during such sixty (60) day period, VIB shall use commercially reasonable efforts to transfer to Ampio any Tramadol Know-How (or copies thereof) identified

 

10


as “non-essential” in the Technology Transfer Plan; provided however that Ampio agrees and acknowledges that certain of such “non-essential” Tramadol Know-How may not be easily obtainable by or on behalf of VIB and that, provided that VIB complies with its obligations under this Section 5.2, that it is not required to provide to Ampio copies of all of such “non-essential” Tramadol Know-How and that if VIB fails to transfer all of such “non-essential” Tramadol Know-How to Ampio that it shall not in any way prevent, delay or otherwise impact the payment by Ampio of the Initial Consideration to VIB. Ampio shall reimburse VIB for its reasonable costs of complying with such Technology Transfer Plan; provided VIB informs Ampio and obtains Ampio’s approval prior to incurring such costs. For the purposes of this Section 5.2, “commercially reasonable efforts” shall include VIB making a request of its third party service providers and suppliers (including suppliers of raw materials), engaged in connection with the [***] studies known to VIB as [***], to provide copies of any Tramadol Know-How in their possession.

5.3     Technology Transfer Assistance from Ampio . Ampio agrees to provide reasonable assistance to VIB in connection with the transfer of the Tramadol Know-How to Ampio, including by making available certain representatives of Ampio to assist VIB in conducting searches of certain materials located at the VIB facilities.

5.4     NDA Agreement . No later than the earlier of (i) five (5) Business Days prior to the Closing and (ii) VIB obtaining an Ethypharm Consent executed on behalf of Ethypharm, VIB shall provide Ampio with a complete, unredacted copy of the NDA Agreement.

5.5     Samples . Within thirty (30) days of Closing, VIB shall deliver the Samples to Ampio, as instructed by Ampio. Ampio shall be responsible for all reasonable costs of VIB in delivering such Samples to Ampio or the facilities designated by Ampio.

5.6     Confidentiality . VIB undertakes with Ampio, and Ampio undertakes with VIB, to keep confidential (except as expressly provided in this Agreement) at all times after the Closing Date, and not directly or indirectly reveal, disclose or use for its own or any other purposes unrelated to its performance or the enforcement of its rights hereunder, any confidential information received or obtained as a result of entering into or performing, or supplied by or on behalf of a Party in the negotiations leading to, this Agreement and which relates to: (i) the negotiations relating to this Agreement; or (ii) the subject matter and/or provisions of this Agreement. The prohibition in this Section 5.6 does not apply if: (i) the information was in the public domain before it was furnished to the relevant Party or, after it was furnished to that Party, entered the public domain otherwise than as a result of (x) a breach by that Party of this Section 5.6 or any other confidentiality agreement which that Party is bound or (y) a breach of a confidentiality obligation by the disclosure by a Third Party where the breach was previously known to that Party; or (ii) disclosure is necessary in order to comply with Applicable Law, provided that any such information discloseable pursuant to this Section 5.6 shall be disclosed only to the extent required by Applicable Law and, unless such consultation is prohibited by Applicable Law or is not reasonably practicable, only after consultation with VIB or Ampio (as the case may be). The Parties acknowledge and agree that Ampio shall be entitled to disclose this Agreement in its

 

 

* Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.

 

11


filings with the United States Securities and Exchange Commission; provided however that, no less than five (5) Business Days prior to the filing of this Agreement with the United States Securities and Exchange Commission, Ampio provides VIB with a copy of the Agreement to be filed, including any proposed redactions to the provisions of such Agreement, and Ampio will consider, acting reasonably, the inclusion in such filing of any additional redactions to the provisions of the Agreement that VIB reasonably requests.

5.7     Interim Covenants . From and after the date hereof and until the Closing, except (i) as otherwise expressly contemplated by this Agreement or (ii) as permitted by the prior written consent of Ampio, (a) VIB will pay or perform all obligations relating to the NDA Agreement as they become due and owing in the ordinary course of business, (b) VIB will not take (or omit to take) any action or enter into any transaction which, if effected before the date of this Agreement, would constitute a breach of the representations, warranties or agreements of VIB contained in this Agreement; and (c) VIB will not take (or omit to take) any action or enter into any transaction which would prevent or delay the consummation of the transactions contemplated under this Agreement.

5.8     Covenant Not To Sue . Notwithstanding anything to the contrary contained in this Agreement, from and after the Closing, VIB shall not, and shall cause its Affiliates not to, sue or bring an action or proceeding seeking to enforce any intellectual property rights to prevent or restrict Ampio or its Affiliates, licensees or subcontractors (i) from developing, manufacturing, importing, using, marketing, commercializing, distributing, or selling Tramadol Products anywhere in the world, (ii) from developing, manufacturing, importing, using, marketing, commercializing, distributing, or selling an Ampio Product with the Active Ingredient as the sole active ingrendient and for use in the indication of premature ejaculation anywhere in the world or (iii) from using, utilizing or otherwise exploiting the Tramadol Know-How or other Purchased Assets, and the rights, titles and interests thereto and therein, in connection with the development, manufacture, importation, use, marketing, commercialization, distribution, or sale of an Ampio Product anywhere in the world; provided however that this Section 5.8 shall not operate to prevent VIB from bringing any claims for indemnification against Ampio that it is entitled to bring pursuant to Article 8.

5.9     Regulatory or Governmental Audits . The Parties agree that each shall cooperate with respect to any audit or inspection by Governmental Entity regarding the Tramadol Product or the Ampio Product, as the case may be. In particular, each Party shall grant access to such Governmental Entity to the books and records related to the Tramadol Products, in the case of VIB, and related to the Ampio Products, in the case of Ampio, in each case in such Parties’ possession or control for the purposes of such audit or inspection.

5.10     No Other Ongoing Obligations of VIB . Ampio acknowledges that, except as expressly set out herein, VIB shall have no responsibilities or obligations with respect to the development, registration, marketing, distribution, manufacturing and sale of the Ampio Product.

ARTICLE 6

REPRESENTATIONS AND WARRANTIES OF VIB

 

6.1 VIB hereby represents and warrants to Ampio as follows:

 

12


6.1.1 Organization; Good Standing . VIB is a society with restricted liability, duly organized, validly existing and in good standing under the laws of Barbados and is in good standing in every jurisdiction where the nature of the business conducted by it makes such qualification necessary, except where the failure to so qualify or be in good standing would not have a material adverse effect on VIB or its ability to perform its obligations hereunder.

 

6.1.2 Authority; Execution and Delivery . VIB has the requisite power and authority to enter into the Agreement and the Transaction Documents and to consummate the transactions contemplated hereby. The execution and delivery of the Agreement and the Transaction Documents by VIB and the consummation of the transactions contemplated hereby have been duly and validly authorized. The Agreement has been duly executed and delivered by VIB and, assuming the due authorization, execution and delivery of the Agreement by Ampio, constitutes the legal, valid and binding obligation of such entity, enforceable against it in accordance with its terms, subject to general principles of equity, including principles of commercial reasonableness, good faith and fair dealing (regardless of whether enforcement is sought in a proceeding at law or in equity).

 

6.1.3 Consents; No Violation, Etc . The execution and delivery of the Agreement do not, and the consummation of the transactions contemplated hereby and the compliance with the terms hereof will not (a) violate any Applicable Law applicable to VIB in the Territory, (b) conflict with any provision of the certificate of organization or by-laws of VIB, or (c) conflict with any material agreement to which VIB is a party or by which it is otherwise bound or (d) require any approval, authorization, consent, license, exemption, filing or registration with any court, arbitrator or Governmental Entity.

 

6.1.4 Purchased Assets . VIB has good and valid title to all of the Purchased Assets, free and clear of any mortgage, charge, lien, security interest, easement, right of way, pledge or encumbrance of any nature whatsoever.

 

6.1.5 NDA Agreement . The NDA Agreement is in full force and effect and constitutes a legal, valid and binding agreement of VIB and Ethypharm, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies. VIB has not received written notice that it is in default under, or in breach of, the NDA Agreement. To the Knowledge of VIB, Ethypharm is not in default under, or in breach of, the NDA Agreement. VIB has the right to assign the NDA Agreement, subject to obtaining the Ethypharm Consent.

 

6.1.6 Litigation . There is no suit, claim, action, investigation or proceeding pending against VIB or, to the actual knowledge of VIB, threatened against VIB that relates to the subject matter of this Agreement or the transactions contemplated hereby, which (a) if adversely determined, would result in a material adverse effect on the assets, rights and licenses being transferred hereby, taken as a whole, or (b) challenges or seeks to prevent or enjoin the transactions contemplated by the Agreement.

 

13


6.1.7 Samples. The Samples were part of one or more batches of Tramadol Product manufactured by or on behalf of VIB and used by VIB in clinical trials [***]. The Samples have been stored by VIB under substantially the same conditions as those under which VIB stores clinical trial material for its own clinical trials.

6.2     Limited Warranty . Except as expressly set forth in this Agreement and the NDA Agreement, the Purchased Assets are provided by VIB without warranty of merchantability or fitness for a particular purpose or any other warranty of any kind, express or implied. Except for the express representations and warranties contained in this Agreement, VIB does not make any representations or warranties whatsoever. Additionally, VIB makes no express or implied representations or warranties that the Purchased Assets will not infringe any patent, copyright, trademark or other rights.

ARTICLE 7

REPRESENTATIONS AND WARRANTIES OF AMPIO

 

7.1 Ampio hereby represents and warrants to VIB as follows:

 

7.1.1 Organization; Good Standing . Ampio is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and is in good standing in every jurisdiction where the nature of the business conducted by it makes such qualification necessary, except where the failure to so qualify or be in good standing would not have a material adverse effect on Ampio or its ability to perform its obligations hereunder.

 

7.1.2 Authority; Execution and Delivery . Ampio has the requisite corporate power and authority to enter into the Agreement and the Transaction Documents and to consummate the transactions contemplated hereby. The execution and delivery of the Agreement and the Transaction Documents by Ampio and the consummation of the transactions contemplated hereby have been duly and validly authorized. The Agreement has been duly executed and delivered by Ampio and, assuming the due authorization, execution and delivery of the Agreement by VIB, constitutes the legal, valid and binding obligation of Ampio, enforceable against Ampio in accordance with its terms, subject to general principles of equity, including principles of commercial reasonableness, good faith and fair dealing (regardless of whether enforcement is sought in a proceeding at law or in equity).

 

7.1.3 Consents; No Violations, Etc . The execution and delivery of the Agreement do not, and the consummation of the transactions contemplated hereby and the compliance with the terms hereof will not (a) violate any Applicable Law applicable to Ampio, (b) conflict with any provision of the articles of incorporation or bylaws of Ampio, (c) conflict with any material agreement to which Ampio is a party or by which it is otherwise bound or (d) require any approval, authorization, consent, license, exemption, filing or registration with any court, arbitrator or Governmental Entity.

 

 

* Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.

 

14


7.1.4 Litigation . There is no suit, claim, action, investigation or proceeding pending against Ampio or, to the actual knowledge of Ampio, threatened against Ampio, that challenges or seeks to prevent or enjoin the transactions contemplated by the Agreement.

ARTICLE 8

SURVIVAL OF REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION

8.1     Survival . All representations and warranties of VIB and Ampio contained herein or made pursuant hereto shall survive the Effective Date for a period of twelve (12) months after the Effective Date. The covenants and agreements of the Parties contained in the Agreement shall survive and remain in full force for the applicable periods described therein or, if no such period is specified, for twelve (12) months after the Effective Date. Any right of indemnification pursuant to Article 8 hereof with respect to a claimed breach of a (a) representation or warranty shall expire at the date of termination of the representation or warranty claimed to be breached, and (b) covenant shall expire one (1) year after the date of termination of the covenant claimed to be breached, unless in both cases on or prior to such date the Party from whom indemnification is sought shall have received notice in accordance with the provisions of Section 8.4 hereof. The provisions of this Section 8.1 shall survive for so long as any other Section of the Agreement shall survive.

8.2     Indemnification by VIB . VIB hereby agrees to indemnify Ampio and its Affiliates and their respective officers, directors and employees (the “ Ampio Indemnified Parties ”) against, and agrees to hold them harmless from, any Loss to the extent such Loss arises from or in connection with (i) any breach by or on behalf of VIB of any representation or warranty contained in the Agreement, (ii) any breach by or on behalf of VIB of any of its covenants contained in the Agreement, (iii) the negligence or willful misconduct of VIB or VIB’s Affiliates, or (iv) the Retained Liabilities; except, in each case, to the extent that such Losses are attributable to any of the matters for which Ampio is required to indemnify the VIB Indemnified Parties pursuant to Section 8.3.

8.3     Indemnification by Ampio . Ampio hereby agrees to indemnify VIB and its Affiliates and their respective officers, directors and employees (the “ VIB Indemnified Parties ”) against, and agrees to hold them harmless from, any Loss to the extent such Loss arises from or in connection with (i) any breach by or on behalf of Ampio of any representation or warranty contained in the Agreement, (ii) any breach by or on behalf of Ampio of any covenant contained in the Agreement, (iii) the negligence or willful misconduct of Ampio or Ampio’s Affiliates, (iv) the development, manufacture, distribution, marketing, sale or use of the Ampio Product on or after the Closing Date, (v) any Product Liability Claims or other claims asserted by Third Parties related to the Ampio Product, except to the extent such other claims arise from events, acts or omissions occurring prior to the Closing Date, or (vi) the Assumed Liabilities; except, in each case, to the extent that such Losses are attributable to any of the matters for which VIB is required to indemnify the Ampio Indemnified Parties pursuant to Section 8.2.

 

15


8.4 Procedure .

 

8.4.1 Indemnification Process Generally . In order for an indemnified party under this Article 8 (an “ Indemnified Party ”) to be entitled to any indemnification provided for under the Agreement, such Indemnified Party shall, promptly following the discovery of the matters giving rise to any Loss, notify the indemnifying party under this Article 8 (the “ Indemnifying Party ”) in writing of its claim for indemnification for such Loss, specifying in reasonable detail the nature of such Loss and the amount of the liability estimated to accrue therefrom; provided, however, that failure to give such prompt notification shall not affect the indemnification provided hereunder except to the extent the Indemnifying Party shall have been actually prejudiced as a result of such failure (except that the Indemnifying Party shall not be liable for any expenses incurred during the period in which the Indemnified Party failed to give such notice). Thereafter, the Indemnified Party shall deliver to the Indemnifying Party, within five (5) Business Days after the Indemnified Party’s receipt of such request, all information and documentation reasonably requested by the Indemnifying Party with respect to such Loss.

 

8.4.2

Third Party Claims . If the indemnification sought pursuant hereto involves a claim made by a Third Party against the Indemnified Party (a “ Third Party Claim ”), the Indemnifying Party shall be entitled to participate in the defense of such Third Party Claim and, if it so chooses, to assume the defense of such Third Party Claim with counsel selected by the Indemnifying Party. Should the Indemnifying Party so elect to assume the defense of a Third Party Claim, the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by the Indemnified Party in connection with the defense thereof. If the Indemnifying Party assumes such defense, the Indemnified Party shall have the right to be represented in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by the Indemnifying Party, it being understood that the Indemnifying Party shall control such defense. The Indemnifying Party shall be liable for the reasonable fees and expenses of counsel employed by the Indemnified Party for any period during which the Indemnifying Party has not assumed the defense thereof (other than during any period in which the Indemnified Party shall have failed to give notice of the Third Party Claim as provided above). If the Indemnifying Party chooses to defend or prosecute a Third Party Claim, the other party hereto shall cooperate in the defense or prosecution thereof. Such cooperation shall include the retention and (upon the Indemnifying Party’s request) the provision to the Indemnifying Party of records and information which are reasonably relevant to such Third Party Claim, and making employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party will agree to any settlement, compromise or discharge of such Third Party Claim which the Indemnifying Party may recommend and which by its terms (i) obligates the Indemnifying Party to pay the full amount of the liability in connection with such Third Party Claim, (ii) includes a full release in favor of the Indemnified Party with respect to the Third Party Claim, does not include any admission of liability and contains reasonable provisions maintaining the confidentiality of the

 

16


  settlement, compromise or discharge, and (iii) does not impair the rights of the Indemnified Party. Whether or not the Indemnifying Party shall have assumed the defense of a Third Party Claim, the Indemnified Party shall not admit any liability with respect to, or settle, compromise or discharge, such Third Party Claim without the Indemnifying Party’s prior written consent, which will not be unreasonably withheld or delayed.

 

8.5 Certain Limitations on Indemnification .

 

8.5.1 Indirect Damages . IN NO EVENT SHALL ANY PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTIES FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT; provided that such limitation on liability shall not apply to Third Party Claims, as such damages shall be deemed direct damages notwithstanding the characterization of such damages in the underlying Third Party Claim.

 

8.5.2 Notwithstanding anything to the contrary contained herein, in no event shall the aggregate indemnification to paid by VIB hereunder exceed the aggregate amount of Initial Consideration and Additional Consideration actually paid by Ampio to VIB at such time.

ARTICLE 9

TERMINATION

9.1     Termination by Ampio . Following the good faith discussions described in Section 5.2, if VIB has failed to transfer to Ampio all of the Tramdaol Know-How identified as “essential” in the Technology Transfer Plan within sixty (60) days of the Effective Date (or such longer period as agreed to by the Parties) and the Parties have not agreed to alternate arrangements with respect to the transfer of the Tramadol Know-How, then Ampio shall have the right to terminate this Agreement in accordance with Section 9.3. If Ampio so terminates, then it shall have no obligation to pay to VIB the Initial Consideration or the Additional Consideration.

9.2     Termination by VIB. If Ampio has failed to pay to VIB the Initial Consideration when due, VIB shall have the right to terminate this Agreement in accordance with Section 9.3. If VIB so terminates, then Ampio shall have no obligation to pay to VIB the Initial Consideration or the Additional Consideration.

9.3     Effect of Termination by VIB . In the event of a termination of this Agreement by Ampio or VIB pursuant to Section 9.1 or 9.2, respectively, Ampio shall assign, convey, transfer and deliver all right, title and interest in the Purchased Assets sold, assigned, transferred and conveyed by VIB to Ampio pursuant to Section 2.1 of this Agreement and Ampio undertakes to:

 

17


9.3.1 return to VIB, within thirty (30) days of the effective date of termination, all documents and data containing Confidential Information of VIB disclosed by Ampio;

 

9.3.2 return to VIB, within thirty (30) days of the effective date of termination, all documents, materials, information and data containing or constituting Tramadol Know-How;

 

9.3.3 cease utilizing the Purchased Assets anywhere in the Territory;

 

9.3.4 assign the NDA Agreement to VIB or VIB’s designee, as instructed by VIB; and

 

9.3.5 destroy or return, at the discretion of VIB, any and all remaining Samples held by or in the possession or control of Ampio or its Affiliates or sublicensees or subcontractors and, within thirty (30) days of the effective date of termination, provide a certificate to VIB certifying to such destruction or return.

With respect to the assignment of the NDA Agreement from Ampio to VIB pursuant to Section 9.3.4, pending receipt of the consent of Ethypharm to such assignment, the Parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide to VIB the benefits of use of the NDA Agreement that it would have obtained had the NDA Agreement been assigned to VIB at the effective date of termination of this Agreement. As of the effective date of the termination of the Agreement and until the NDA Agreement has been assigned to VIB, Ampio shall not take any action under the NDA Agreement without obtaining the prior written consent of VIB and shall take all reasonable actions at VIB’s cost in relation to the NDA Agreement requested by VIB. If any such consent cannot be obtained within ninety (90) days of the effective date of the termination, Ampio shall use its commercially reasonable efforts to obtain for VIB substantially all of the practical benefit and burden of the NDA Agreement, including by entering into appropriate and reasonable alternative arrangements on terms mutually agreeable to VIB and Ampio.

9.4     Survival . If Ampio or VIB terminates this Agreement pursuant to Section 9.1 or 9.2, the following provisions of this Agreement shall survive: Sections 5.6 and 9.3, this Section 9.4 and Articles 6, 7, 8 and 10. In any event, termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such termination.

ARTICLE 10

MISCELLANEOUS

10.1     Notices . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the party for whom it is intended, delivered by registered or certified mail, return receipt requested, or by a national overnight courier service, or sent by facsimile, to the Person at the address or facsimile number set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such Person:

 

18


To VIB:

        Valeant International (Barbados) SRL

        Welches Christ Church

        Barbados, BB17154

        Facsimile: (246) 420-1532

        Attention: President

To Ampio:

        Ampio Pharmaceuticals, Inc.

        5445 DTC Parkway, Suite 925

        Greenwood Village, Colorado 80111

        Facsimile: 720-437-6501

        Attention: Chief Executive Officer

With a required copy to:

        Goodwin Procter LLP

        Exchange Place

        53 State Street

        Boston, Massachusetts 02109

        Attention: Lawrence Wittenberg, Esq.

        Facsimile: 617-523-1231

All notices and other communications under this Agreement shall be deemed to have been received (i) when delivered by hand, if personally delivered, (ii) three (3) Business Days after being delivered by registered or certified mail, return receipt requested, (iii) one (1) Business Day after being delivered to a national overnight courier service or (iv) on the date of receipt, if sent by facsimile.

10.2     Amendment; Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed (i) in the case of an amendment, by VIB and Ampio, and (ii) in the case of a waiver, by the Party against whom the waiver is to be effective. No failure or delay by either Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.

10.3     Assignment . The terms and provisions of this Agreement shall inure to the benefit of, and be binding upon, the Parties and their respective successors and permitted assigns. Neither Party shall assign or otherwise transfer this Agreement or its rights and obligations thereunder without the prior written consent of the other Party, provided that no such consent shall be required in connection with an assignment or transfer upon a sale of all or substantially all of the assets of the Party to a Third Party. In addition, either Party may, on notice to the other Party, assign, sublicense, subcontract or delegate all or any of its rights and obligations under this Agreement to an Affiliate, so long as the assigning or transferring Party remains fully responsible for the performance of its Affiliate.

 

19


10.4     Entire Agreement . This Agreement, together with the Transaction Document, contains the entire agreement among the Parties with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral or written, with respect to such matters.

10.5     Public Disclosure . Notwithstanding anything herein to the contrary, each Party hereby agrees with the other Party, except as may be required to comply with the requirements of any Applicable Law or the rules and regulations of each stock exchange upon which the securities of such Party are listed, if any, (in which case such Party shall notify without delay the other Party and provide the other Party with a copy of the contemplated disclosure prior to submission or release, as the case may be, unless notifying is impracticable due to circumstances beyond such Party’s control) that no press release or similar public announcement or communication shall, at any time, be made by it or caused to be made by it concerning the execution or performance of this Agreement unless it shall have consulted the other Party in advance with respect thereto and such other Party consents in writing to such release, announcement or communication.

10.6     Expenses . Except as otherwise provided in this Agreement, whether or not the Closing takes place, all costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be paid by the Party incurring such costs and expenses.

10.7     Governing Law; Jurisdiction; No Jury Trial . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to any conflicts of law principles thereof to the extent such principles would permit or require the application of the laws of another jurisdiction. The Parties consent to the exclusive jurisdiction of the Federal and State courts located in New York City, New York. Each of the Parties (i) consents to the jurisdiction of each such court in any such suit, action or proceeding, (ii) waives any objection that it may have to the laying of venue in any such suit, action or proceeding in any such court and (iii) agrees that service of any court paper may be made in such manner as may be provided under applicable Laws or court rules governing service of process. THE PARTIES HERETO HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN ANY SUCH ACTION PERMITTED HEREUNDER.

10.8     Severability . The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any term or other provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid, illegal or unenforceable, (a) a suitable and equitable provision shall be substituted therefore in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision and (b) the remainder of this Agreement and the application of such provision to other Persons or circumstances shall not be affected by such invalidity, illegality or unenforceability, nor shall such invalidity, illegality or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other jurisdiction.

 

20


10.9     Execution and Delivery . This Agreement may be executed by the Parties in counterparts and may be executed and delivered by facsimile or e-mail transmissions and all such counterparts, (whether original, e-mail or facsimile) together constitute one and the same agreement.

[ signature page follows ]

 

21


IN WITNESS WHEREOF, this Agreement has been duly executed and delivered by a duly authorized representative of each of VIB and Ampio as of the Effective Date.

A MPIO P HARMACEUTICALS , I NC .

 

By:   /s/ Don Wingerter
Name: Don Wingerter
Title:   CEO

V ALEANT I NTERNATIONAL (B ARBADOS ) SRL

 

By:   /s/ Richard K. Masterson
Name: Richard K. Masterson
Title:   President and COO

 

22


EXHIBIT A

Assumption Agreement

See attached.

 

23


ASSUMPTION OF LIABILITIES AGREEMENT

THIS AGREEMENT made this             day of             , 2011

B E T W E E N:

AMPIO PHARMACEUTICALS, INC. , a Delaware corporation (hereinafter referred to as “Ampio”)

OF THE FIRST PART

– and –

VALEANT INTERNATIONAL (BARBADOS) SRL, a Barbados international society with restricted liability (hereinafter referred to as “VIB”)

OF THE SECOND PART

WHEREAS pursuant to an Asset Purchase Agreement (the “Purchase Agreement”) between Ampio and VIB, dated December 2, 2011, Ampio agreed, among other things, to assume the Assumed Liabilities (as the term is used in the PurchaseAgreement) of VIB;

AND WHEREAS the PurchaseAgreement calls for the delivery of this Agreement.

NOW THEREFORE, in consideration of these premises, the covenants and agreements hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto covenant and agree as follows:

1.     Capitalized Terms . All capitalized terms not otherwise defined herein shall have the meanings respectively assigned thereto in the Purchase Agreement.

2.     Assignment and Assumption . VIB hereby assigns, transfers, conveys and delivers to Ampio, all of VIB’s right, title and interest in, to and under the Assumed Liabilities, but specifically excluding the Retained Liabilities. Ampio hereby assumes the Assumed Liabilities as part of the consideration being paid in connection with the execution of the PurchaseAgreement and the transactions contemplated thereby and agrees to duly and punctually observe and perform the covenants, provisos and conditions on the part of VIB pertaining to the Assumed Liabilities.Ampioassumes from VIB none of the Retained Liabilities.

3.     Further Assurances . VIB agrees that it will at all times hereafter at the request and expense of Ampio execute and deliver all such instruments of assignment, conveyance, endorsement or authorization and other documents or take such additional action as Ampio may reasonably require.

4.     Enurement . This Agreement shall be binding upon and enure to the benefit of the Parties hereto and their respective successors and permitted assigns.


5.     Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to any conflicts of law principles thereof to the extent such principles would permit or require the application of the laws of another jurisdiction. The Parties consent to the exclusive jurisdiction of the Federal and State courts located in New York City, New York. Each of the Parties (i) consents to the jurisdiction of each such court in any such suit, action or proceeding, (ii) waives any objection that it may have to the laying of venue in any such suit, action or proceeding in any such court and (iii) agrees that service of any court paper may be made in such manner as may be provided under applicable Laws or court rules governing service of process. THE PARTIES HERETO HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN ANY SUCH ACTION PERMITTED HEREUNDER.

6.     Execution and Delivery . This Agreement may be executed by the Parties in counterparts and may be executed and delivered by facsimile or e-mail transmissions and all such counterparts, (whether original, e-mail or facsimile) together constitute one and the same agreement.

[ signature page follows ]

 

2


IN WITNESS WHEREOF the Parties hereto have executed this Agreement on the date first above written.

 

AMPIO PHARMACEUTICALS, INC.
Per:    

Name:

Title:

 

VALEANT INTERNATIONAL

(BARBADOS) SRL

Per:    

Name:

Title:

 

3


EXHIBIT B

Bill of Sale

See attached.


BILL OF SALE

THIS AGREEMENT made this             day of             , 2011

B E T W E E N:

AMPIO PHARMACEUTICALS, INC. , a Delaware corporation (hereinafter referred to as “Ampio”)

OF THE FIRST PART

– and –

VALEANT INTERNATIONAL (BARBADOS) SRL, a Barbados international society with restricted liability (hereinafter referred to as “VIB”)

OF THE SECOND PART

WITNESSES THAT:

WHEREAS pursuant to an Asset Purchase Agreement (the “Purchase Agreement”) between Ampio and VIB, dated December 2, 2011, among other things, VIB agreed to sell and Ampio agreed to purchase the Samples and the Tramadol Know-How;

AND WHEREAS the Purchase Agreement calls for the delivery of this Bill of Sale;

NOW THEREFORE, in consideration of these premises, the covenants and agreements hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto covenant and agree as follows:

1.         All capitalized terms not otherwise defined herein shall have the meanings respectively assigned thereto in the Purchase Agreement.

2.          VIB does hereby bargain, sell, assign, transfer, convey, deliver and set over unto Ampio, effective as of the date hereof, all of VIB’s right, title and interest in and to the Samples and the Tramadol Know-How.

3.          Ampio hereby purchases, accepts and acquires from VIB the Samples and the Tramadol Know-How.

4.          The Parties hereto covenant and agree that they will from time to time and at all times hereafter, upon the reasonable request of the other Party but at the expense of the other Party, make, do and execute or cause and procure to be made, done and executed all such further acts, deeds or assurances as may be reasonably required by the other party to carry out the true intent and meaning of this Agreement fully and effectually.

5.          This Agreement shall in no way limit, derogate from or otherwise affect and is without prejudice to the covenants, agreements, representations, warranties, indemnities and obligations contained in the PurchaseAgreement, all of which shall continue in full force and effect for their benefit in accordance with the terms of the PurchaseAgreement.


6.          This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to any conflicts of law principles thereof to the extent such principles would permit or require the application of the laws of another jurisdiction. The Parties consent to the exclusive jurisdiction of the Federal and State courts located in New York City, New York. Each of the Parties (i) consents to the jurisdiction of each such court in any such suit, action or proceeding, (ii) waives any objection that it may have to the laying of venue in any such suit, action or proceeding in any such court and (iii) agrees that service of any court paper may be made in such manner as may be provided under applicable Laws or court rules governing service of process. THE PARTIES HERETO HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN ANY SUCH ACTION PERMITTED HEREUNDER.

7.          This Agreement shall enure to the benefit of and be binding upon the Parties hereto and their respective successors and assigns.

8.          This Agreement may be executed by the Parties in counterparts and may be executed and delivered by facsimile or e-mail transmissions and all such counterparts, (whether original, e-mail or facsimile) together constitute one and the same agreement.

[signature page follows]

 

2


IN WITNESS WHEREOF VIB and Ampio have duly executed this Bill of Sale as of the date set out above.

 

AMPIO PHARMACEUTICALS, INC.
Per:    

Name:

Title:

 

VALEANT INTERNATIONAL

(BARBADOS) SRL

Per:    

Name:

Title:

 

3


EXHIBIT C

Contract Assignment and Assumption Agreement

See attached.


CONTRACT ASSIGNMENT AND ASSUMPTION AGREEMENT

THIS AGREEMENT made this             day of             , 2011

BETWEEN:

AMPIO PHARMACEUTICALS, INC. , a Delaware corporation (hereinafter referred to as “Ampio”)

OF THE FIRST PART

– and –

VALEANT INTERNATIONAL (BARBADOS) SRL, a Barbados international society with restricted liability (hereinafter referred to as “VIB”)

OF THE SECOND PART

WHEREAS pursuant to an Asset Purchase Agreement (the “Purchase Agreement”) between Ampio and VIB, dated December 2, 2011, VIB agreed, among other things, to assign to Ampio the NDA Agreement (as defined in the Purchase Agreement);

AND WHEREAS the Purchase Agreement calls for the delivery of this Agreement;

NOW THEREFORE, in consideration of these premises, the covenants and agreements hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto covenant and agree as follows:

1.          Capitalized Terms . All capitalized terms not otherwise defined herein shall have the meanings respectively assigned thereto in the Purchase Agreement.

2.          Assignment . In accordance with and subject to the terms of the Purchase Agreement, VIB hereby sells, assigns and transfers to Ampio effective as of the date hereof, the NDA Agreement, together with all of its rights and privileges and benefits to be derived therefrom, including the full power and authority to enforce the performance of the covenants and other matters and things contained in the NDA Agreement.

3.          Assumption . In accordance with and subject to the terms of the Purchase Agreement, Ampio hereby assumes all of VIB’s obligations and liabilities arising under the NDA Agreement arising from and after the Closing Date and agrees to duly and punctually observe and perform the covenants, provisos and conditions on the part of VIB contained in the NDA Agreementarising from and after the Closing Date.

4.          Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to any conflicts of law principles thereof to the extent such principles would permit or require the application of the laws of another jurisdiction. The Parties consent to the exclusive jurisdiction of the Federal and State courts


located in New York City, New York. Each of the Parties (i) consents to the jurisdiction of each such court in any such suit, action or proceeding, (ii) waives any objection that it may have to the laying of venue in any such suit, action or proceeding in any such court and (iii) agrees that service of any court paper may be made in such manner as may be provided under applicable Laws or court rules governing service of process. THE PARTIES HERETO HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN ANY SUCH ACTION PERMITTED HEREUNDER.

5.          Further Assurances . VIB agrees that it will at all times hereafter at the request and expense of Ampio execute and deliver all such further assurances in respect of this Agreement as Ampio may reasonably require.

6.          Enurement . This Agreement shall be binding upon and enure to the benefit of the Parties hereto and their respective successors and permitted assigns.

7.          Execution and Delivery . This Agreement may be executed by the Parties in counterparts and may be executed and delivered by facsimile or e-mail transmissions and all such counterparts, (whether original, e-mail or facsimile) together constitute one and the same agreement.

[signature page follows]

 

2


IN WITNESS WHEREOF the Parties have caused this Agreement to be executed as of the date first above written.

 

AMPIO PHARMACEUTICALS, INC.
Per:    

Name:

Title:

 

VALEANT INTERNATIONAL

(BARBADOS) SRL

Per:    

Name:

Title:

 

3


EXHIBIT D

Ethypharm Consent

1.         Effective as of the Closing Date, Ethypharm hereby consents to and accepts the assignment by VIB of the NDA Agreement to Ampio.

2.         [***]

IN WITNESS WHEREOF, this Consent To Assignment has been duly executed and delivered by a duly authorized representative of Ethypharm and VIB as of the Closing Date.

 

E THYPHARM     V ALEANT I NTERNATIONAL (B ARBADOS ) SRL
By:         By:    
Name:       Name:  

Title:

     

Title:

 

 

 

* Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.

Exhibit 10.5

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Execution Copy

MANUFACTURING AND SUPPLY AGREEMENT

by and between

ETHYPHARM S.A.

and

AMPIO PHARMACEUTICALS, INC.

* * *


TABLE OF CONTENTS

 

 

          Page  

ARTICLE 1 DEFINITIONS

     4   

ARTICLE 2 APPOINTMENT OF MANUFACTURER

     8   

2.1

   Requirements      8   

2.2

   Third Party Manufacturer      8   

2.3

   Joint Manufacturing Committee      8   

ARTICLE 3 REGULATORY AND QUALITY UNDERTAKINGS

     9   

3.1

   Regulatory      9   

3.2

   Import and Packaging      9   

3.3

   Change in Specifications      9   

3.4

   Advertising, Promotional Materials, and Public Statements      10   

3.5

   Product Complaints and Adverse Drug Experiences      10   

3.6

   Facility Maintenance; Inspection; Reports      10   

3.7

   Filing Requirements and Maintenance      10   

3.8

   Product Recall      11   

3.9

   Quality Agreement      11   

ARTICLE 4 FORECAST, ORDER, SUPPLY PRICE, SUPPLY INTERRUPTION

     12   

4.1

   Forecast Reports      12   

4.2

   Product Orders      12   

4.3

   Batch Sizes of Product      12   

4.4

   Inventories      12   

4.5

   Supply Price of the Product      13   

4.6

   Supply Interruption      13   

4.7

   Deficiency Notice      14   

4.8

   Determination of Deficiency      14   

4.9

   Rejection for Deficiency      15   

ARTICLE 5 WARRANTIES AND COVENANTS

     15   

5.1

   Certain Representations and Warranties of Ethypharm      15   

5.2

   Certain Representations and Warranties of Ampio      15   

5.3

   Certain Covenants of Ampio      16   

5.4

   Certain Covenants of Ethypharm      16   

5.5

   Storage      16   


5.6

   Representation and Warranties with Regard to Status      16   

5.7

   Compliance with Specifications and cGMP      16   

5.8

   Limitation of Warranty      17   

ARTICLE 6 INDEMNIFICATION AND LIMITATION OF LIABILITY

     17   

6.1

   Ethypharm’s Indemnification Obligations      17   

6.2

   Ampio’s Indemnification Obligations      17   

6.3

   Indemnification Procedures      17   

6.4

   Limitation of Liability      18   

ARTICLE 7 INSURANCE

     18   

ARTICLE 8 CONFIDENTIALITY

     19   

8.1

   Treatment of Confidential Information      19   

8.2

   Limits on Disclosure      19   

ARTICLE 9 TERM AND TERMINATION

     20   

9.1

   Term      20   

9.2

   Termination for Breach      20   

9.3

   Termination for Bankruptcy      20   

9.4

   Withdrawal of Regulatory Approval and NDA      20   

9.5

   No Waiver of Termination Rights      20   

ARTICLE 10 FORCE MAJEURE

     21   

10.1

   Effects of Force Majeure      21   

10.2

   Notice of Force Majeure      21   

ARTICLE 11 Miscellaneous

     21   

11.1

   Dispute Resolution      21   

11.2

   Independent Contractors      22   

11.3

   Assignment      22   

11.4

   Governing Law      22   

11.5

   No Implied Waiver      22   

11.6

   Notice      22   

11.7

   Amendments      23   

11.8

   Counterparts      23   

11.9

   Interpretation      24   

11.10

   Entire Agreement      24   

11.11

   Benefit; Binding Effect      24   

11.12

   Survival      24   

11.13

   Further Assurances      24   

11.14

   Severability      24   

11.15

   Use of Names; Publicity      25   
     


CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

 

MANUFACTURING AND SUPPLY AGREEMENT

THIS MANUFACTURING AND SUPPLY AGREEMENT (the “ Agreement ”), dated as of September 10, 2012 (the “Effective Date”), is entered into by and between ETHYPHARM S.A. , a corporation organized under the laws of France with an address at 194 Bureaux de la Colline, F92213 Saint-Cloud, France (“ Ethypharm ”), and AMPIO PHARMACEUTICALS, INC. , a corporation organized under the laws of the state of Delaware with an address at 5445 DTC Parkway, Suite 925, Greenwood Village, Colorado 80111, USA (“ Ampio ”).

WHEREAS, Ethypharm and Valeant International (Barbados) SRL (formerly Biovail Laboratories International, SRL) (“Valeant”) entered into that certain NDA Assignment and License Agreement dated as of February 6, 2009 (the “ License Agreement ”) under which Valeant was given rights from Ethypharm to use the Technology (as defined below) to develop and commercialize the Product (as defined below) on a worldwide basis;

WHEREAS, pursuant to that certain Contract Assignment and License Agreement, dated December 20, 2011, between Valeant and Ampio, Ampio was assigned all of Valeant’s rights under the License Agreement;

WHEREAS, pursuant to the terms of the License Agreement, Ampio has developed the Product and its related Regulatory Documentation (as defined below) and is in the process of registration of the Product in different countries of the Territory (as defined below).

WHEREAS, pursuant to the terms of the License Agreement, Ampio has engaged Ethypharm, who has accepted, as its exclusive manufacturer and supplier of the Product in the Territory;

NOW, THEREFORE, in consideration of the foregoing premises and mutual covenants of the Parties hereinafter set forth, the parties agree as follows:

ARTICLE 1

DEFINITIONS

Affiliate ” means, with respect to any Person, any other Person that (directly or indirectly) is controlled by, controls, or is under common control with such Person. For purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means direct or indirect beneficial or legal ownership of more than fifty percent (50%) of the voting interest in, or more than fifty percent (50%) of the equity of or the right to appoint more than fifty percent (50%) of the directors or managers of the corporation or other business entity or the power to direct or cause the direction of the management and policies of such corporation or entity, whether pursuant to the ownership of voting securities, by contract or otherwise.


“cGMP” shall mean the practices required with respect to the manufacture of the Product by the provisions of EC Commission Directive 2003/94/CE together with the Guide to Good Manufacturing Practice published by the EC Commission in 1992 (ISBN 92-826-3180-X) and by the Food and Drug Administration in the provisions of 21 C.F.R., parts 210 and 211.

Commercial Manufacturing Site ” means Ethypharm’s manufacturing site at Châteauneuf en Thymerais, France, or any other manufacturing site to be agreed upon by both parties pursuant to the terms of this Agreement.

Commercially Reasonable Efforts ” means, with respect to the efforts to be expended by a party with respect to any objective, reasonable, diligent, good faith efforts to accomplish such objective that such party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that with respect to the research, development or commercialization of the Product, such efforts shall be substantially equivalent to those efforts and resources commonly used by a party for a similar pharmaceutical product owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential taking into account efficacy, safety, anticipated labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval, commercial value of the product, alternative products and other relevant factors.

Confidential Information ” means all trade secrets, processes, formulae, data, know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by a party or its Affiliate, or has otherwise become known to a party or its Affiliate, or to which rights have been assigned to or by a party or its Affiliate (including, without limitation all information and materials of a party’s (or its Affiliates’) customers and any other third party and their consultants), in each case that are disclosed by such party or its Affiliate to the other party, regardless of whether any of the foregoing is marked “confidential” or “proprietary” or communicated to the other by the disclosing party in oral, written or graphic, or electronic form; provided, however , that Confidential Information shall not include any information:

(A) that, at the time of its disclosure, is generally available within the industry;

(B) that, after its disclosure in connection herewith, becomes generally available within the industry, through no act or failure to act on the part of the receiving party or its Affiliates;

(C) that becomes available to the recipient of such information from a third party that does not owe a duty of confidentiality to the disclosing party in relation to that Confidential Information; or

(D) that the recipient of which can demonstrate was independently developed by or for such recipient without the aid, application or use of the Confidential Information disclosed to the recipient by the disclosing party or its Affiliates in connection herewith.

 

CONFIDENTIAL    5 | Page


Defect ” means any flaw making the Product dangerous or unsuitable for use or otherwise unsuitable for sale.

Deficiency Notice ” has the meaning set forth in Section 4.7 .

Due Delivery Date ” has the meaning set forth in Section 4.6 .

Effective Date ” means the date hereof.

“EX Works” or :EXW” has the meaning provided in INCOTERM rules of the International Chamber of Commerce of 2010.

FDA ” means the United States Food and Drug Administration or any successor government agency.

First Commercial Sale ” means the first sale of the Product under this Agreement by Ampio, its Affiliates or Licenses in arms’ length transaction to an unaffiliated Person.

Forecast Report ” has the meaning set forth in Section 4.1 .

Ineligible Person ” has the meaning set forth in Section 5.6 .

Infringement Notice ” has the meaning set forth in Section 11.1 .

Intellectual Property ” means all (i) patent applications, continuation applications, continuation in part applications, divisional applications, any corresponding foreign patent applications to any of the foregoing, and any patents that may grant or may have been granted on any of the foregoing, including reissues, re-examinations and extensions; (ii) rights in know-how, trade secrets, inventions (whether patentable or otherwise), data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether patentable or not; (iii) copyrightable works, copyrights and applications, registrations and renewals; (iv) other intellectual proprietary rights; in each case, whether or not registered, applied for or granted; and (v) copies and tangible memorializations of any one or more of the foregoing.

Losses ” has the meaning set forth in Section 6.1 .

Notice of Observations ” has the meaning set forth in Section 3.6 .

Person ” means a natural person, corporation, partnership, company or other entity.

“Pain Field” means the prevention and/or treatment of pain in human beings.

 

CONFIDENTIAL    6 | Page


“Product ” means an oral rapid dissolve or oral disintegrating tablet formulation of TRAMADOL as the only active pharmaceutical ingredient in [***] dosage strengths for indication outside the Pain Field manufactured in accordance with the Specifications.

Quality Agreement ” has the meaning set forth in Section 3.9 .

Regulatory Approval ” means the approvals or authorizations of relevant Regulatory Authorities, necessary for the import, marketing and sale of the Product in the Territory.

Regulatory Authority ” means any competent regulatory authority or other governmental body responsible for approving and authorizing the import, manufacture or marketing of Product in the Territory.

Regulatory Documentation ” means all submissions to the FDA or other Regulatory Authorities as applicable, including, without limitation, any clinical data, clinical studies, tests, and biostudies, NDAs, as well as all correspondence with regulatory authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files, manufacturing records and inspection reports, in each case related to or used in connection with the Product.

Specifications ” means all those manufacturing, testing, packaging, labeling, storage and quality control specifications established for the Product by Ampio in compliance with the requirements of the cGMPs and other regulatory requirements, as set forth in Exhibit C hereto as may be supplemented or amended from time to time by agreement of the parties, as further defined in the Quality Agreement.

Supply Interruption ” has the meaning set forth in Section 4.6 .

Supply Price ” has the meaning set forth in Section 4.5 hereof.

Technology ” means Ethypharm’s proprietary [***] technology, and all patents, patent applications, trademarks, copyrights, proprietary know-how and all other related Intellectual Property rights owned by Ethypharm relating to the Product.

Term ” has the meaning set forth in Section 9.1 hereof.

Territory ” means all the different countries where the Product will be marketed by Ampio or its Licenses.

Third Party Manufacturer ” has the meaning set forth in Section 2.2 .

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

CONFIDENTIAL    7 | Page


ARTICLE 2

APPOINTMENT OF MANUFACTURER

2.1 Requirements . During the Term, subject to Section 4.6 below, Ampio, itself or through its Affiliates or Licensees, shall purchase all of their requirements for Product exclusively from Ethypharm, or its Third Party Manufacturer as applicable, and Ethypharm, and its Third Party Manufacturer as applicable, shall manufacture and supply to Ampio, its Affiliates and Licenses all of their requirements for Product. All Product manufactured and supplied hereunder whether by Ethypharm or Third Party Manufacturer shall be performed in compliance with the Quality Agreement and Specifications including cGMP and all applicable laws, rules and regulations.

2.2 Third Party Manufacturer . Ethypharm shall not subcontract its manufacturing and supply obligations hereunder to any third party; provided, however , upon the prior written consent of Ampio, Ethypharm shall be entitled to contract with a third party for the purposes of such party’s producing part or all of the Product, and maintaining quality control with respect to such Product, in lieu of and on behalf of Ethypharm (a “ Third Party Manufacturer ”) in which case Ethypharm shall remain liable to Ampio for all of its obligations, including but not limited to the performance of the Third Party Manufacturer, herein, and Ampio shall either (at Ethypharm’s discretion) start purchasing the Product directly from the Third Party Manufacturer (according to the same terms and conditions as apply to the supply of Product by Ethypharm to Ampio hereunder), or continue purchasing the Product through Ethypharm. Ethypharm shall give Ampio reasonable notice of any proposal to appoint a Third Party Manufacturer and shall satisfy all legal and regulatory requirements relating to any variation of the Regularity Approval relating to such appointment at its own cost and shall procure for Ampio reasonable inspection and audit rights (which rights are no less favorable to Ampio than those it possesses hereunder with respect to Ethypharm) in respect of the Third Party Manufacturer’s Manufacturing Site. Ethypharm shall warrant in writing to Ampio that the Third Party Manufacturer: (i) has and will maintain the requisite capacity to satisfy Ethypharm’s production and delivery obligations, and to meet Ampio’s order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all applicable laws and holds all applicable licensees and permits necessary for the manufacture of the Product in compliance with cGMP; (iii) has and will have the right to use all related intellectual property and Confidential Information of Ethypharm necessary to manufacture the Product in accordance with the Specifications and the terms and conditions of this Agreement.

2.3 Joint Manufacturing Committee. On the Effective Date, the parties will establish a Joint Manufacturing Committee consisting of four members, two of whom shall be appointed by Ethypharm and two of whom shall be appointed by Ampio. Initially, Ethypharm’s representatives to the Committee shall be Hafid Touam and Antoine Poncy, and Ampio’s representative shall be Amy Poshusta and one additional to be named. The Committee shall meet, either in person or by teleconference, at least quarterly to discuss the following matters relating to the manufacture and supply of the Product:

1. coordinate forecasting, ordering and other supply-related logistics;

 

CONFIDENTIAL    8 | Page


2. discuss supply-related issues, including shortfalls and quality issues;

3. discuss and coordinate manufacturing-related complaints, recalls and any other supply related issues;

4. review and discuss proposals to engage, qualify and maintain Third Party Manufacturers and Additional Manufacturing Facilities;

5. discuss the content and scope of any quality audit undertaken, or to be undertaken, relating to Third Party Manufacturers;

6. review and agree on budgets for any additional technical assistance agreed to by the parties;

7. discuss requirements for supply of Product and mechanisms to maintain supply, e.g., by increasing batch sizes and/or capacity or through additional sources;

8. discuss technology and regulatory issues including tech transfer, changes in Specifications, API sourcing, stability studies, inspections and audits; and

9. perform such other functions as may be appropriate with respect to the manufacture of the Product.

All decisions of the Joint Manufacturing Committee will be made by unanimous vote. If the Committee cannot reach agreement on any particular issue, the issue will be brought to the Chief Executive Officers of the parties, who shall have a period of 30 days to find an acceptable resolution to the issue. If the issue is not resolved during such 30 day period, either party may bring the issue to a court of competent jurisdiction for resolution, in accordance with Section 11.1 below.

ARTICLE 3

REGULATORY AND QUALITY UNDERTAKINGS

3.1 Regulatory . Ampio, as the holder of the Regulatory Approval, shall be responsible for obtaining, maintaining and fulfilling all legal and regulatory requirements in the Territory at its own cost, with respect to the Product during the Term, as required by all applicable laws and regulations in the Territory.

3.2 Import and Packaging . Ampio shall be responsible for the shipping, freight and handling of Product following its delivery to Ampio at the Commercial Manufacturing Site and shall additionally be responsible for finished product packaging operations with respect to Product and shall ensure compliance with any and all laws and regulations in the Territory to the import and export of the Product in the Territory.

3.3 Change in Specifications . In the event that a Regulatory Authority imposes any change affecting the manufacture of the Product, the parties, acting through the Joint Manufacturing Committee, shall discuss in good faith with a view to reaching agreement on the

 

CONFIDENTIAL    9 | Page


actions and timing required to effect such change, which shall be at the costs and expense of Ampio. All such changes required by any Regulatory Authorities or by Ampio shall be made at Ampio’s costs and expenses. Any modifications to Specifications and /or the manufacturing instructions shall be implemented and validated in accordance with the terms of the Quality Agreement.

3.4 Advertising, Promotional Materials, and Public Statements . Ampio shall be solely responsible for all sales, marketing and advertising activities related to the Product in the Territory and shall ensure that all advertising and promotional materials comply with applicable laws, rules and regulations in the Territory.

3.5 Product Complaints and Adverse Drug Experiences . Ampio shall, at its sole cost and expense, be responsible for handling all customer Product complaints and all adverse event reporting, annual reporting, pharmacovigilance and other required, ongoing regulatory reporting activities normally and customarily associated with sales and marketing of pharmaceutical products in the Territory, in each case, in accordance with applicable laws.

3.6 Facility Maintenance; Inspection; Reports . Each party shall maintain and operate its respective facilities and implement such quality control procedures so as to meet the requirements of applicable FDA or any other relevant regulations and so as to be able to perform timely its obligations hereunder. Each party shall (and shall cause its Third Party Manufacturers and packagers, if applicable, to) permit quality assurance representatives of the other party to inspect its facilities, including the Commercial Manufacturing Site, once per calendar year upon reasonable written notice, during normal business hours and on a confidential basis; provided , that, if an inspecting party finds any non-compliance during any such inspection with respect to the Product, the party subject to inspection shall (i) use Commercially Reasonable Efforts to promptly and diligently rectify such non-compliance and implement appropriate procedures with a view to avoiding such non-compliance and (ii) permit such additional inspection(s) by the inspecting party as such inspecting party shall deem reasonably necessary to verify that such non-compliance has been rectified. Each party shall promptly provide the other party with a copy of any correspondences exchanged with any Regulatory Authorities, together with the response and corrective action taken by the party with respect to the Product.

3.7 Filing Requirements and Maintenance . Ampio shall promptly comply with all filing and reporting requirements with respect to the Product, including general reporting requirements necessary to keep and maintain the Regulatory Documentation for the Regulatory Approval current with the Regulatory Authority and any applicable clinical study. Ampio shall be responsible for conducting all stability studies at its own cost and expense that may be required for ongoing marketing and sale of the Product during the Term and such stability studies shall be conducted in compliance with the Regulatory Documentation, the Regulatory Approval and other Regulatory Authorities requirements.

 

CONFIDENTIAL    10 | Page


3.8 Product Recall .

                (a) Ampio or its Affiliates, licensees or Licenses shall be responsible for handling the recall or seizure of any Product distributed by or on behalf of Ampio hereunder at its own costs and expense. Notwithstanding the foregoing, in the event Ampio decides to recall or seize any Product distributed under this Agreement, and such recall or seizure is found to have been caused by a failure of Ethypharm to manufacture the Product in accordance with Specifications or cGMP, Ethypharm shall reimburse Ampio for all external costs associated with such recall or seizure (including shipping, handling costs and credits to customers). Any decision to recall, withdraw or cease distribution of Product shall be made by Ampio only following consultation with Ethypharm, taking such reasonable action as it considers to be appropriate under the circumstances to limit the risk to both parties and assure compliance by the parties with the requirements of applicable laws. For purposes of this Section 3.8 , “ recall ” means (i) any action by Ethypharm, Ampio or any Affiliate of either to recover title to or possession of any Product sold or shipped (including, but not limited to, market withdrawal) and/or (ii) any decision by Ampio not to sell or ship any Products to third parties that would have been subject to recall if they had been sold or shipped, in each case taken in the good faith belief that such action was appropriate under the circumstances. For purposes of this Section 3.8 , “ seizure ” means any action by any governmental authority to detain or destroy any Product.

                (b) Following the First Commercial Sale, Ethypharm and Ampio shall keep the other fully informed in writing of any notification or other information, whether received directly or indirectly, that might (i) affect the Regulatory Authority’s approval to market the Product under the Regulatory Approval or the safety or effectiveness of the Product, (ii) result in liability issues or otherwise necessitate action on the part of either party, or (iii) result in the recall or seizure of the Product. Ampio will be responsible for assuring that such recall is closed-out with relevant Regulatory Authority.

3.9 Quality Agreement . As promptly as practicable after the Effective Date, but in any event no later than six months following the date of receipt by Ampio or its distributors or licensees of the first Regulatory Approval for the Product in the Territory, the parties will negotiate in good faith and execute a Quality Agreement (the “Quality Agreement”) setting forth each party’s obligations for ensuring that the Product is manufactured and sold in compliance with cGMP and concerning the delimitation of pharmaceutical and quality responsibilities for the manufacturing operations of the Product. This agreement shall contain administrative information with responsibilities, supply and manufacturing (premises, materials, batch numbering, shelf life and other information), customary provisions, including change control, deviation, cGMP compliance, complaint handling and investigation, annual product review, QC testing (specification and method), documentations and inspections, batch release, product recalls, stability studies and other quality related items in accordance with applicable regulation and guidelines in the Territory.

 

CONFIDENTIAL    11 | Page


ARTICLE 4

FORECAST, ORDER, SUPPLY PRICE, SUPPLY INTERRUPTION

4.1 Forecast Reports . No later than six months following the date of receipt by Ampio or its distributors or licensees of the first Regulatory Approval for the Product in the Territory, Ampio shall provide Ethypharm with a twelve (12) month forecast of its estimated requirements of the Product, which shall be updated quarterly during the Term to ensure that Ethypharm has at all times a twelve (12) month forecast for Ampio’s estimated requirements of the Product (the “ Forecast Report ”). The Forecast Report shall be expressed in quantities of bulk tablet units of Product. Forecast Reports shall be provided to Ethypharm for information purposes only and shall not constitute a firm commitment.

4.2 Product Orders . Ampio shall provide Ethypharm with binding and non-cancellable orders of the Product four (4) months in advance, except for the first order to support the First Commercial Sale (the “ Commercial Launch Supply ”) which shall be placed six (6) months in advance. Ethypharm shall accept all orders by written notice no later than ten (10) days following receipt of each relevant order and shall deliver such quantities of Product ordered unless the quantities ordered by Ampio vary by more than twenty-five percent (25%) from the quantities indicated in the applicable Forecast Report. Ethypharm shall work with Ampio using Commercially Reasonable Efforts to deliver such quantities of Product that exceed more than twenty-five percent (25%) of the estimated quantities of Product of the concerned Forecast Report. Ampio shall provide Ethypharm in each order with the exact quantity of Product, delivery date and the address to which the Product must be sent. These binding orders shall be considered as firm offers and shall bind the Parties as soon as they are accepted in writing by Ethypharm.

4.3 Batch Sizes of Product And Inventories.

(a) Each binding order placed by Ampio shall correspond to one full batch or multiple full batches of the Product. A full batch size of Product is defined in Exhibit A of this Agreement.

(b) Any proposed change in batch size shall be discussed with the Joint Manufacturing Committee before implementation. Ethypharm shall be responsible for implementing at its own discretion, any change in batch size during the Term taking into account the Forecast Reports. Ampio shall be responsible for obtaining all regulatory approvals, required, to implement changes in full batch size required hereunder.

4.4 Inventories . Ampio shall at all times use reasonable efforts to keep adequate inventories of Product to meet the market demand in the Territory. These inventories shall be sufficient to cover the estimated requirement for at least four (4) months. At Ampio’s request, such inventories shall be kept at Ethypharm’s facility on Ampio’s behalf.

 

CONFIDENTIAL    12 | Page


4.5 Supply Price of the Product .

(a) All Product manufactured by Ethypharm or a Third Party Manufacturer, shall be supplied in bulk tablet form ready for packaging and shall be delivered EX WORKS Ethypharm’s Commercial Manufacturing Site. Ethypharm Supply Price to Ampio is defined in Exhibit B of this Agreement. Ampio or its designated distributor or sublicensee shall be responsible for the shipping, freight and handling of the Product from Ethypharm’s Commercial Manufacturing Site and finished dosage packaging. Ampio (a) shall pay Product invoices within thirty (30) days of date of invoice. Ethypharm shall supply the Product in bulk tablet forms ready for packaging and shall deliver the Product to Ampio, EX WORKS (Ethypharm’s Commercial Manufacturing Site) (Incoterm 2010). The Supply Price as determined above includes the active ingredient, excipients, testing and manufacturing workmanship according to Ethypharm’s usual standards and in compliance with cGMPs.

(b) [***]

(c) Ampio shall be responsible for all duties, tariffs, import and similar charges other than sales and use taxes arising out of or related to the manufacture of the Product. None of these costs shall be subject to recoupment by Ampio from Ethypharm under this Agreement.

(d) At any time during the Term of this Agreement, in the event that one of the Parties produces the written proof that an unforeseeable event beyond the control of the Parties affects the economical conditions of the present Agreement so as to modify substantially the contractual balance of this Agreement for the sole benefit of one of the Party, the Parties agree to revise the Supply Prices in good faith, taking into consideration the market of the Product in the Territory, in order to put back both Parties in a situation similar to the existing situation at the date of signature of the Agreement. Each Party reserves the right to terminate this Agreement if the Parties are unable to reach an agreement within three (3) months starting from the first demand of conciliation by the most diligent Party.

4.6 Supply Interruption . A “ Supply Interruption ” shall be deemed to have occurred if Ampio has not received ordered Product for more than sixty (60) days past the scheduled and agreed upon due delivery date (“ Due Delivery Date ”) and Ampio holds no saleable stock of the Product after attempting to maintain at least four (4) months of sealable stock through binding orders made pursuant to Section 4.3 (subject to Ethypharm’s delivery thereof), unless such Supply Interruption is caused by (a) a delay due to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio for which Ethypharm has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled to claim from Ethypharm a penalty of one per cent (1%) of the amount of the late deliveries value of Product from the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio within thirty (30) days date of Ampio’s invoice. Notwithstanding the other provisions of

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

CONFIDENTIAL    13 | Page


this Agreement, if a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) to require Ethypharm to use a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third party.

4.7 Deficiency Notice . Ampio shall have the right to reject any portion of any delivery of Product that deviates from Specifications without invalidating any remainder of such delivery. Ampio shall inspect the Product upon receipt thereof and shall give Ethypharm written notice (a “ Deficiency Notice ”) of all claims for Product that deviates from the Specifications within thirty (30) days after Ampio’s receipt thereof (or, in the case of any Defect not reasonably susceptible to discovery upon receipt by Ampio, within thirty (30) days after discovery thereof by Ampio, up until the final release of the Product in its commercial packaging). Should Ampio fail to provide Ethypharm with a Deficiency Notice within the applicable period, then the delivery shall be deemed to have been accepted by Ampio upon the expiration of such period. Notwithstanding the foregoing, if Ampio discovers that any Product materially deviates from Specifications after final release of the Product in its commercial packaging, such deviation was not reasonably susceptible to discovery upon receipt of the Product from Ethypharm, and Ampio reasonably determines that such deviation was due to Ethypharm’s manufacturing, Ampio may reject the delivery of such Product within thirty (30) days after discovery thereof by Ampio, up until the final expiration date of the Product.

4.8 Determination of Deficiency . Upon receipt of a Deficiency Notice, Ethypharm shall have ten (10) business days to advise Ampio by notice in writing that it disagrees with the contents of such Deficiency Notice. Should Ethypharm fail to provide Ampio with a response to such Deficiency Notice within the applicable period, then the delivery shall be deemed to have deviated from the Specifications upon the expiration of such period. If Ethypharm responds to such Deficiency Notice during such period and Ampio and Ethypharm fail to agree within ten (10) business days of the date of Ethypharm’s response to Ampio as to whether any Product identified in the Deficiency Notice deviates from the Specifications, the parties shall mutually select an independent laboratory to analyze the Product for compliance with the Specifications. Such analysis shall be binding on the parties, and Ampio may reject such Product if such analysis determines that the Product in question deviates from the Specifications. If such analysis certifies that the Product does not deviate from the Specifications, Ampio shall be deemed to have accepted delivery of such Product on the fortieth (40th) day after delivery (or, in the case of any Defect not reasonably susceptible to discovery upon receipt of the Product or Defect discovered after final release by Ampio of the Product in its commercial packaging pursuant to Section 4.7 above, on the fortieth (40th) day after discovery by Ampio, but in no event after the expiration date of the Product).

 

CONFIDENTIAL    14 | Page


4.9 Rejection for Deficiency . If any delivery of Product is deemed or agreed upon to deviate from the Specifications, at Ampio’s option, Ethypharm shall either (a) accept a return of such delivery, correct such delivery with replacement Product, if required, as soon as reasonably practicable and reimburse Ampio for its shipping costs in connection with such delivery and such returns within thirty (30) days, or (b) shall reimburse Ampio for Ampio’s costs (including the purchase price of the Product and shipping costs with respect thereto within thirty (30) days.

ARTICLE 5

WARRANTIES AND COVENANTS

5.1 Certain Representations and Warranties of Ethypharm . Ethypharm represents and warrants to Ampio that as of the Effective Date (i) Ethypharm is duly organized and validly existing under the laws of the jurisdiction of its incorporation or organization; (ii) Ethypharm has the full right, power and authority to enter into this Agreement and to perform the activities required to be performed by it in accordance with this Agreement; (iii) this Agreement is legally binding upon Ethypharm and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by Ethypharm does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation or order of any court, governmental body or administrative or other agency having jurisdiction over it; (iv) there is no action, suit, proceeding or investigation pending or threatened, against Ethypharm that questions the validity of this Agreement or the right of Ethypharm to enter into this Agreement or consummate the transactions contemplated hereby, nor does Ethypharm have knowledge that there is any basis for the foregoing; (v) Ethypharm is not in violation of any law or regulation, nor is it aware of any violation of any law or regulation by any other person, which violation could reasonably be expected to adversely affect its performance of its obligations hereunder and (vi) Ethypharm is the owner or licensee of its Intellectual Property and Technology pertaining to the Product, which is free and clear of any liens, charges and encumbrances.

5.2 Certain Representations and Warranties of Ampio . Ampio represents and warrants to Ethypharm that as of the Effective Date (i) Ampio is duly organized and validly existing under the laws of the jurisdiction of its incorporation or organization; (ii) Ampio has the full right, power and authority to enter into this Agreement, to perform the activities required to be performed by it in accordance with this Agreement; (iii) this Agreement is legally binding upon Ampio and enforceable in accordance with its terms, and the execution, delivery, and performance of this Agreement by Ampio does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; (iv) there is no action, suit, proceeding or investigation pending or threatened against Ampio that questions the validity of this Agreement or the right of Ampio to enter into this Agreement or consummate the transactions contemplated hereby, nor does Ampio have knowledge that there is any basis for the foregoing; (v) Ampio is not in violation of any law or regulation, nor is it aware of any violation of any law or regulation by any other person, which violation could reasonably be expected to adversely affect its performance of its obligations

 

CONFIDENTIAL    15 | Page


hereunder; (vi) Prior to First Commercial Sale in any particular jurisdiction, Ampio or its distributor or licensee shall secure the right under the relevant Regulatory Approval to pursue marketing and sale of the Product in such jurisdiction.

5.3 Certain Covenants of Ampio . Ampio covenants and agrees, on behalf of itself and its Affiliates, that during the Term (i) any Intellectual Property of Ampio, including in particular trademarks of Ampio that are to be utilized by Ampio in connection with the labeling and packaging of the Product are (or will be) the property of Ampio, may be lawfully used as directed by Ampio; (ii) it will not develop or perform any formulation or any developmental or other work or studies on or with respect to the Product for its own use or benefit or for the use or benefit of any Person in the Territory, other than pursuant to the development and commercialization of the Product pursuant to the terms of the License Agreement.

5.4 Certain Covenants of Ethypharm . Ethypharm covenants and agrees on behalf of itself and its Affiliates and Third Party Manufacturer that it will not during the Term, directly or indirectly alone, with or through a Third Party, sell, develop, manufacture or market a product containing tramadol anywhere in the world that is a dosage strength that is not a multiple of 25mg or not in the Pain Field, without the prior written consent of Ampio.

5.5 Storage . Tablets of the Product under Ethypharm’s or Ampio’s control (as the case may be) prior to distribution by Ampio in the Territory shall be stored by Ethypharm or Ampio in a compliant manner and handled in accordance with the Regulatory Documentation and applicable cGMP requirements.

5.6 Representation and Warranties with Regard to Status . Ampio and Ethypharm each hereby represent and warrant to the other that, subject to the receipt by Ampio or its distributors or sublicensees of relevant Regulatory Approvals, neither it, their Affiliates, nor in the case of Ethypharm the Third Party Manufacturer nor any of the officers, directors or employees of the foregoing is prohibited by any law, rule or regulation or by any order, directive or policy from selling the Product or other pharmaceutical products within the Territory and that neither it nor any of its officers, directors, employees or Affiliates or Third Party Manufacturer is a Person that is listed by a United States federal agency as debarred, suspended or otherwise ineligible for federal programs in the United States, its territories and protectorates (an “ Ineligible Person ”) or proposed for such debarment or suspension.

5.7 Compliance with Specifications and cGMP . Ethypharm covenants and agrees that the Product, when delivered to Ampio, will be manufactured, controlled and supplied in accordance with the Specifications and with cGMP; the Product will meet Ethypharm’s quality assurance standards; Product ingredients and contents will conform with the list and Specifications for ingredients set forth in the Regulatory Approval. Ethypharm will sell the Product to Ampio free of all liens and encumbrances. Ethypharm and Ampio shall execute the Quality Agreement in accordance with the terms hereof.

 

CONFIDENTIAL    16 | Page


5.8 Limitation of Warranty . EITHER PARTY GIVES NO OTHER WARRANTY UNDER THIS AGREEMENT, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF NON-INFRINGEMENT, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 6

INDEMNIFICATION AND LIMITATION OF LIABILITY

6.1 Ethypharm’s Indemnification Obligations . Ethypharm shall indemnify and hold Ampio and its Affiliates and their respective officers, directors, stockholders, employees and agents harmless from and against, and pay or reimburse, any claim, action, suit, proceeding, loss, liability, damage or expense (including reasonable attorneys’ fees) (collectively, “ Losses ”) related to claims asserted by any third party, directly or indirectly, as a result of Ethypharm’s or its Affiliates’ or Third Party Manufacturer’s failure to manufacture the Product in accordance with the Specifications or cGMP or of Ethypharm’s breach of any of its representations, warranties, covenants hereunder; provided, however , that Ethypharm shall not be required to indemnify Ampio with respect to any such Losses to the extent such Losses arise from or relate to Ampio’s or its Affiliates’ negligent acts or omissions, willful wrongful acts or Ampio’s breach of its representations, warranties, covenants or other obligations hereunder.

6.2 Ampio’s Indemnification Obligations . Ampio shall indemnify and hold Ethypharm and its Affiliates and their respective officers, directors, stockholders, employees and agents harmless from and against, and pay or reimburse, any Losses related to claims asserted by any third party, directly or indirectly, as a result of: (a) Ampio’s or its Affiliates’ negligent acts or omissions, willful wrongful acts or breach of any of its representations, warranties, covenants or other obligations hereunder; (b) liabilities, expenses or damages arising from the actions of Ampio to promote, market, commercialize, distribute and sell the Product in the Territory; and (d) liabilities, expenses or damages arising from the actions of Ampio’s distributors, Affiliates and Licenses or brought by such distributors, Affiliates or Licenses; provided, however , that Ampio shall not be required to indemnify Ethypharm with respect to any such Losses to the extent such Losses arise from or relate to Ethypharm’s, its Affiliates’ or subcontractors’ negligent acts or omissions, willful wrongful acts or Ethypharm’s breach of its representations, warranties, covenants or other obligations hereunder.

6.3 Indemnification Procedures . A party that intends to claim indemnification under this Article 6 (the “ indemnitee ”) with respect to any third-party action, claim or liability shall notify the other party (the “ indemnitor ”) promptly in writing of any action, claim or liability in respect of which the indemnitee believes it is entitled to claim indemnification; provided , that the failure to give timely notice to the indemnitor shall not release the indemnitor from any liability to the indemnitee except to the extent the indemnitor is materially prejudiced thereby. The indemnitor shall have the right, by written notice to the indemnitee, to assume the defense of any such action or claim, within the fifteen (15) day period after the indemnitor’s receipt of written notice of any action or claim, with counsel of the indemnitor’s choice and at the sole cost of the indemnitor. If the indemnitor so assumes such defense, the indemnitee may

 

CONFIDENTIAL    17 | Page


participate therein through counsel of its choice, but at the sole cost of the indemnitee; provided, however , if the defendants in any such action include both the party seeking indemnification and the indemnifying party, and the party seeking indemnification shall reasonably conclude that there may be legal defenses available to it which are different from or additional to, or inconsistent with, those available to the indemnifying party, the party seeking indemnification shall have the right to select separate counsel to participate in the defense of such action on behalf of such party seeking indemnification, at the indemnifying party’s expense. If the indemnitor fails to assume such defense and/or to diligently prosecute the same, the indemnitee may assume such defense at the indemnitor’s sole expense. The party not assuming the defense of any such claim shall render all reasonable assistance to the party assuming such defense, and all reasonable out-of-pocket costs of such assistance shall be for the account of the indemnitor. No such claim shall be settled other than by the party defending the same, and then only with the prior written consent of the other party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however , that the indemnitee shall have (i) no obligation to consent to any settlement of any such action or claim that (a) imposes on the indemnitee any monetary or other liability or obligation that is not assumed and agreed to be performed in full by the indemnitor or (b) adversely affects the indemnitee’s rights hereunder or damages its reputation or business, and (ii) no right to withhold its consent to any settlement of any such action or claim if the settlement involves only the payment of money by the indemnitor or its insurer without admission of liability by the indemnitee and the indemnitor or its insurer irrevocably agrees in writing to make such payment. If the parties are unable to agree as to the application of Sections 6.1 and 6.2 to any claim, pending resolution of the dispute in accordance with Section 11.1 , the parties may conduct separate defenses of such claims, with each party retaining the right to claim indemnification from the other party in accordance with Sections 6.1 and 6.2 upon resolution of the underlying action.

6.4 Limitation of Liability . NEITHER PARTY SHALL BE LIABLE WITH RESPECT TO ANY CLAIM RELATED TO THIS AGREEMENT FOR ANY SPECIAL, INCIDENTAL OR INDIRECT DAMAGES, INCLUDING ANY LOSS OF INCOME, LOSS OF PROFITS, COSTS OF SUBSTITUTION, COSTS OF COVER OR INCREASED CAPITAL COSTS, REGARDLESS OF THE FORM OR NATURE OF ACTION, WHETHER IN CONTRACT, BREACH OF WARRANTY, STRICT LIABILITY, EQUITY, INDEMNITY, NEGLIGENCE, INTENTIONAL CONDUCT, TORT OR OTHERWISE, EVEN IF SUCH DAMAGES WERE FORESEEABLE OR IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE 7

INSURANCE

Each of Ampio and Ethypharm shall (and shall cause their respective Affiliates and Sub-licensees, as required, to), upon the Effective Date, carry or be subject to coverage (as a named insured) under product liability insurance in an amount of not less than [***] combined single limit, which insurance shall be written on a “claims-made” policy basis with an insurance carrier rated at least A- by Bests Rating Service or a comparable rating by a comparable rating service.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

CONFIDENTIAL    18 | Page


Each party shall provide the other party with evidence of coverage contemplated hereby, in the form of certificates of insurance, as reasonably requested in writing. Each party shall provide written notice to the other party fifteen (15) days prior to any material change, cancellation or non-renewal of the policy.

ARTICLE 8

CONFIDENTIALITY

8.1 Treatment of Confidential Information . Except as required by applicable laws and regulations or as otherwise provided in this Article 8 , during the Term, and for ten (10) years thereafter, each party shall hold in confidence, and may not disclose, in whole or in part, to a third party (except as specifically set forth herein or with the express prior written consent of the other party) any and all Confidential Information of the other party and its Affiliates. During the Term, the parties may not use any Confidential Information of the other party and its Affiliates for purposes other than those permitted by this Agreement and the License Agreement.

8.2 Limits on Disclosure . Without limiting the generality of the foregoing, each party may, with the exercise of reasonable discretion, (i) disclose Confidential Information to those employees or agents who need to receive the Confidential Information in order to further the activities contemplated by this Agreement; and (ii) make disclosures of such portions of Confidential Information to third-party consultants, attorneys, contractors, advisors, Affiliates and governmental authorities where, in such party’s judgment, such disclosure is beneficial to the development, approval or marketing of the Product pursuant to this Agreement; provided, that such party shall take reasonable precautions to safeguard the Confidential Information, including by obtaining appropriate commitments and enforceable confidentiality agreements having provisions no less stringent than those contained herein.

(a) Each party understands and agrees that the wrongful disclosure of Confidential Information may result in serious and irreparable damage to the other party, that the remedy at law for any breach of this covenant may be inadequate, and that the party seeking redress hereunder shall be entitled to injunctive relief, without prejudice to any other rights and remedies to which such party may be entitled.

(b) Except as otherwise set forth in this Agreement, upon the termination or expiration of this Agreement and at the written request of the disclosing party, the receiving party shall return all Confidential Information of the disclosing party (including all copies, excerpts and summaries thereof contained on any media) or destroy such Confidential Information at the option of the receiving party; provided, that the receiving party may retain one copy of all Confidential Information of the disclosing party for its legal records.

 

CONFIDENTIAL    19 | Page


ARTICLE 9

TERM AND TERMINATION

9.1 Term . This Agreement shall be effective immediately upon the Effective Date and shall remain into effect for a period of ten (10) years from the Effective Date (the “ Term ”). Upon the expiry of the Term, this Agreement will be automatically renewed for one or more additional three (3) year periods, unless terminated by any of the Parties six (6) months prior to the end of the initial period, or any of the renewed period, by proper notice.

9.2 Termination for Breach . If either party commits a material breach or default in the performance or observance of any of its obligations under this Agreement, other than nonpayment of a monetary obligation, and such breach or default continues for a period of sixty (60) days after delivery by the other party of written notice reasonably detailing such breach or default, or, if the non-performing party shall promptly, within such sixty (60) days, proceed with all due diligence to cure such failure, and such failure is not cured within such longer period (not to exceed one hundred eighty (180) additional days) as shall be reasonably necessary for such party to cure the same with all due diligence, then the non-breaching or non-defaulting party shall have the right to terminate this Agreement, with immediate effect, by giving written notice to the breaching or defaulting party. Nonpayment of a monetary obligation is deemed a material breach hereunder and the non-breaching party may terminate this Agreement if such breach continues for a period of thirty (30) days after delivery to the breaching party of written notice of non-payment, with termination effective on the date provided for in that. If either Ethypharm, its Third Party Manufacturer or Ampio becomes an Ineligible Person, such status shall constitute a material breach hereunder, and the non-breaching party may terminate this Agreement if such breach continues for a period of thirty (30) days after delivery to the breaching party of written notice of termination, with termination effective on the date provided for in that notice.

9.3 Termination for Bankruptcy . To the extent permitted by law, this Agreement shall automatically terminate upon the initiation of any proceeding in bankruptcy, reorganization or arrangement for the appointment of a receiver or trustee to take possession of the assets of either party or a similar proceeding under law for the release of creditors by or against either party, or if either party makes a general assignment for the benefit of its creditors.

9.4 Withdrawal of Regulatory Approval and NDA . This Agreement may be terminated with respect to relevant countries in the Territory by either party in the event that a Regulatory Authority in the Territory withdraws the concerned Regulatory Approval for future marketing of Product in the concerned country of the Territory.

9.5 No Waiver of Termination Rights . The right of either party to terminate this Agreement, as provided in this Article 9 , shall not be affected in any way by its waiver of, or failure to take action with respect to, any previous default.

 

CONFIDENTIAL    20 | Page


ARTICLE 10

FORCE MAJEURE

10.1 Effects of Force Majeure . A party hereto shall be excused and shall not be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement (other than the payment of money) if such failure or delay is caused by acts of God, acts of the public enemy, fire, explosion, flood, epidemic or other natural physical disaster, drought, war, terrorists, riot, unavailability of raw material, sabotage, embargo, strikes or other labor disputes, intervention of governmental authority, impossibility of the use of railways, shipping, aircraft, motor transport or other means of public or private transport, failure or suspension of utilities, and political interference with the normal operation of either party or by any other event or circumstance of like or different character to the foregoing beyond the reasonable control and without the fault or negligence of the affected party (a “ Force Majeure Event ”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, such party shall promptly resume performance hereunder.

10.2 Notice of Force Majeure . Each party agrees to give the other party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof and the extent to which the affected party will be unable to perform its obligations hereunder. Each party further agrees to use reasonable efforts to correct or otherwise address the Force Majeure Event as soon as practicable and to give the other parties prompt written notice when it is again fully able to perform such obligations.

ARTICLE 11

Miscellaneous

11.1 Dispute Resolution . Ethypharm and Ampio agree to irrevocably submit to the exclusive jurisdiction of (i) the Supreme Court of the State of New York, New York County, U.S.A., or (ii) the United States District Court for the Southern District of New York U.S.A., for the purposes of any suit, action or other proceeding arising out of this Agreement or any transaction contemplated hereby. Each Party agrees to commence any such action, suit or proceeding either in the United States District Court for the Southern District of New York, U.S.A. or, if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County, U.S.A.

EACH PARTY HERETO WAIVES, TO THE EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT, AND EACH PARTY HERETO (i) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THAT FOREGOING WAIVER, AND (ii) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS PARAGRAPH.

 

CONFIDENTIAL    21 | Page


11.2. Independent Contractors . The relationship between Ethypharm, on the one hand, and Ampio, on the other hand, is that of independent contractors and nothing herein shall be deemed to constitute or create the relationship of partners, joint venturers nor of principal and agent between Ethypharm on the one hand and Ampio on the other hand. Neither party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

11.3. Assignment . This Agreement may be assigned and/or delegated by either party to an Affiliate of such party or in connection with any sale, merger or other business combination involving all or substantially all of such party’s assets or capital stock or of the assets to which this Agreement relates. Except as otherwise provided in this Agreement, neither this Agreement nor any other rights or obligations hereunder shall be assigned, transferred or delegated by either party without the prior written consent of the other party, not to be unreasonably withheld, conditioned or delayed. Any permitted assignee shall, upon the request of the other party hereto, expressly acknowledge, by written agreement, its assumption of all obligations and liabilities under this Agreement. Any attempted assignment in violation of the foregoing shall be null and void. This Agreement shall inure to the benefit of each party’s permitted successors and assigns.

11.4. Governing Law . This contract shall be governed by, and construed in accordance with, the laws of the State of New York without reference to that state’s conflicts of laws rules. The parties expressly reject the application of the United Nations Convention on Contracts for the International Sale of Goods and all implementing legislation thereunder.

11.5. No Implied Waiver . No failure or delay on the part of either party hereto to exercise any right, power or privilege hereunder or under any instrument executed pursuant hereto shall, in itself, operate as a waiver; nor shall any single or partial exercise of any right, power or privilege preclude any other or further exercise thereof or the exercise of any other right, power or privilege.

11.6. Notice . All notices required to be given hereunder shall be in writing and shall be given by personal delivery, via facsimile transmission followed by U.S. mail, by a nationally recognized overnight carrier or by registered or certified mail, postage prepaid with return receipt requested. Notices shall be addressed to the parties as follows:

If to Ethypharm:

Ethypharm S.A.

194 Bureaux de la Colline

F92213 Saint-Cloud

 

CONFIDENTIAL    22 | Page


France

Attn: Hugues LECAT—Chairman of the Board—CEO

Facsimile No.: +33 1 41 12 17 30

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

Ethypharm USA Corp.

1500 Market Street, 12th Floor, East Tower

Philadelphia, PA 19102

Attn: Hafid Touam-CEO

Facsimile No.: (610) 994-2302

If to Ampio:

Ampio Pharmaceuticals, Inc.

The Quadrant

5445 DTC Parkway, Suite 925

Greenwood Village, CO 80111

U.S.A.

Attn: Michael Macaluso—Chairman of the Board and CEO

Facsimile (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

Notices delivered personally shall be deemed communicated as of actual receipt; notices sent via facsimile transmission shall be deemed communicated as of receipt by the sender of written confirmation of transmission thereof; notices sent via overnight courier shall be deemed received as of one business day following sending; and notices mailed shall be deemed communicated as of three (3) business days after proper mailing. A party may change his or its address by written notice sent in accordance with this Section 12.6 .

11.7. Amendments . Any amendment or modification of this Agreement shall be valid only if made in writing and signed by both parties hereto.

11.8. Counterparts . This Agreement may be executed in counterparts, each of which shall be deemed an original and both of which shall constitute a single document. A facsimile signature of an authorized signatory of either party shall be valid and binding and constitute due execution and delivery of this Agreement by such party.

 

CONFIDENTIAL    23 | Page


11.9. Interpretation . The Section headings contained in this Agreement are for the convenience of reference only and shall not affect the meaning or interpretation of this Agreement. As used in this Agreement, any reference to the masculine, feminine or neuter gender shall include all genders, the plural shall include the singular, and the singular shall include the plural. Unless the context otherwise requires, the term “ party ” when used herein means a party hereto. References herein to a party or other Person include its respective successors and permitted assigns. The words “ includes ” and “ including ” when used herein shall be deemed to be followed by the phrase “ without limitation ” unless such phrase otherwise appears. Unless the context otherwise requires, references herein to Articles, Sections, Exhibits and Schedules shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this Agreement. Unless the context otherwise requires, the words “ hereof ,” “ hereby ,” “ hereunder ” and “ herein ” and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Section or provision hereof. All monetary amounts in this Agreement are expressed and shall be paid in U.S. dollars. With regard to each and every term and condition of this Agreement, the parties understand and agree that the same has or have been mutually negotiated, prepared and drafted, and that, if, at any time, the parties desire or are required to interpret or construe any such term or condition or any agreement or instrument subject thereto, no consideration shall be given to the issue of which party actually prepared, drafted or requested any term or condition of this Agreement.

11.10. Entire Agreement . This Agreement and the License Agreement constitutes the entire understanding between the parties with respect to the subject matter hereof and supersedes all prior contracts, agreements and understandings related to the same subject matter between the parties. In particular, in case of inconstancies between the terms of the License Agreement and the terms of this Agreement with respect to the manufacture and supply of the Product, the terms of this Agreement shall prevail. The parties intend this Agreement to be a complete statement of the terms of their understanding.

11.11. Benefit; Binding Effect . This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns.

11.12. Survival . Notwithstanding anything to the contrary contained in this Agreement, the provisions of Article 3 (to the extent of post-termination complaints and reporting obligations) and Articles 1 , 5 , 6 , 7 , 8 11 and 12 shall survive, in accordance with their respective terms, any termination or expiration of this Agreement.

11.13. Further Assurances . The parties agree that they shall take all appropriate actions, including the execution or filing of any documents or instruments, that may be reasonably necessary or advisable to carry out the intent and accomplish the purposes of any of the provisions hereof.

11.14. Severability . In the event that any provision of this Agreement shall be held invalid or unenforceable for any reason by a court of competent jurisdiction, such provision or part thereof shall be considered separate from the remaining provisions of this Agreement, which shall remain in full force and effect. Such invalid or unenforceable provision shall be deemed revised to effect, to the fullest extent permitted by applicable law, the intent of the parties as set forth herein.

 

CONFIDENTIAL    24 | Page


11.15. Use of Names; Publicity . Neither party will use the name of the other party or issue any press release or other publicity relating to this Agreement in any form without the written permission of the other, except as may be required by applicable law (including securities exchange rules) or as otherwise contemplated hereunder. Neither party will unreasonably withhold its written permission if the other party desires to issue such a press release or other publicity with respect to this Agreement.

 

CONFIDENTIAL    25 | Page


IN WITNESS WHEREOF , the parties have caused this Agreement to be executed as of the Effective Date.

Date:

 

ETHYPHARM S.A.
By:   /s/ Hugues LECAT
Name:   Hugues LECAT
Title:   CEO—Chairman of Management Board

 

AMPIO PHARMACEUTICALS, INC.
By:   /s/ Michael Macaluso
Name:   Michael Macaluso
Title:   Chairman of the Board and CEO

 

CONFIDENTIAL    26 | Page


EXHIBIT A

BATCH SIZE DEFINITION

A full batch size of Product represents [***].

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

CONFIDENTIAL    27 | Page


EXHIBIT B

SUPPLY PRICES

Ethypharm Supply prices of Product expressed EX WORKS (Ethypharm Commercial Manufacturing Site) taxes excluded, in bulk tablets, to Ampio shall be:

[***]

[***]

The Supply Price as determined above includes the supply of excipients and active drug, the analysis of active drug and excipient, the manufacturing operations according to the standards of ETHYPHARM and the delivery in bulk packaging Ex Works as indicated.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

CONFIDENTIAL    28 | Page


EXHIBIT C

PRODUCT SPECIFICATIONS

 

CONFIDENTIAL    29 | Page

Exhibit 10.7

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

 

 

 

DISTRIBUTION AGREEMENT

DATED AS OF M ARCH  1, 2012

BETWEEN

A MPIO PHARMACEUTICALS , INC .

AND

F BM INDUSTRIA FARMACEUTICA , LTDA .

 

 

 


D ISTRIBUTION A GREEMENT (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

A PPOINTMENT OF D ISTRIBUTOR

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:

 

2


(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

M ARKETING AND P ROMOTION

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.

 

3


(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;

 

4


(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.

 

5


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

D ISTRIBUTION OF P RODUCT

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;

 

6


(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

P URCHASE , S ALE AND D ELIVERY OF P RODUCT

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

 

7


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.

 

8


(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.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

9


(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

C OMPLIANCE WITH L AWS ; R EGULATORY M ATTERS ; R ECYCLING

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

 

10


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.

 

11


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.

 

12


ARTICLE VI

I NTELLECTUAL P ROPERTY R IGHTS

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

C ONFIDENTIALITY

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

R EPRESENTATIONS , W ARRANTIES AND L IABILITIES

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.

 

14


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

I NDEMNIFICATION

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.

 

17


ARTICLE X

T ERM AND T ERMINATION

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.

 

18


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

G ENERAL P ROVISIONS

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.

 

20


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.

 

21


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.

 

23


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.

 

A MPIO P HARMACEUTICALS , I NC .
By:

/s/ Michael Macaluso

Name: Michael Macaluso
Title: Chief Executive Officer
FBM I NDUSTRIA F ARMACEUTICA , L TDA .
By:

/s/ Moises Alves de Oliveira Neto

Name: Moises Alves de Oliveira Neto
Title: Director
FBM I NDUSTRIA F ARMACEUTICA , L TDA .
By:

/s/ Marcelo Reis Perillo

Name: Marcelo Reis Perillo
Title: Director

Exhibit 10.8

*** CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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 (1 st ) 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 (2 nd ) 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 [***].

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

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.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

14


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 (1 st ) 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 (4 th ) 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

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   
       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   
            [***]   
            [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

       [***]           [***]   

[***]

         

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.


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.

Exhibit 10.9

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

SPONSORED RESEARCH AGREEMENT

This Sponsored Research Agreement (the “Agreement”) is made by and between  Trauma Research LLC (“TRLLC”) , a Colorado limited liability company, having its address at 900 East Oxford Lane, Englewood, Colorado 80113 and  DMI Life Sciences, Inc. (“Sponsor”) , a Delaware corporation, with its principal place of business at 8400 East Crescent Parkway, Suite 600, Greenwood Village, Colorado 80111.

RECITALS

[***]

WHEREAS,  Sponsor desires that TRLLC perform certain research work hereinafter described and is willing to advance personnel, equipment and other resources to sponsor such research; and

WHEREAS,  TRLLC is willing to perform such research for Sponsor;

NOW THEREFORE,  in consideration of the mutual covenants and promises herein contained, TRLLC and Sponsor agree as follows:

I. EFFECTIVE DATE

This Agreement shall be effective as of September 1, 2009 (the “Effective Date”).

 

II. RESEARCH PROJECT

2.1  TRLLC will use its best efforts to conduct the research project described in Attachment A, as amended and supplemented from time to time (collectively, the “Research Project”) and will furnish the laboratory facilities necessary to carry out the Research Project. The Research Project will be under the direction of David Bar-Or, M.D. (the “Principal Investigator”) and will be conducted at [***] one or more other suitable facilities selected by TRLLC.

2.2  The Research Project shall be performed commencing on the Effective Date and continuing until August 31, 2014, or until this Agreement is earlier terminated or extended as provided in Article IX.

2.3  [***] The manner of performance of the Research Project shall be determined solely by the Principal Investigator. TRLLC does not guarantee specific results, and the Research Project will be conducted only on a best efforts basis.

2.4  TRLLC will keep accurate financial and scientific records relating to the Research Project and will make such records available to Sponsor or its authorized representative throughout the term of the Agreement and for a period of one year following termination of the Agreement, or for such longer period required by law, during normal business hours upon reasonable notice.

2.5  Sponsor understands that TRLLC, alone or with other researchers, may be involved in conducting research on behalf of other sponsors. TRLLC agrees that all such research will be conducted separately and by different investigators from the Research Project. Sponsor shall not gain any rights via this Agreement to such other research.

2.6  TRLLC does not guarantee that any patent rights will result from the Research Project, that the scope of any patent rights obtained will cover Sponsor’s commercial interests, or that any such patent rights will be free of dominance by other patents.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 


III. SPONSOR CONTRIBUTIONS

3.1 [***]

3.2 [***]

3.3  Within sixty (60) days after the end of each calendar year the Research Project is conducted, the Principal Investigator and the Sponsor’s representative shall meet to evaluate and, if appropriate, to revise the Research Project to accurately reflect anticipated activities for the coming year.

3.4  TRLLC shall maintain any Research Project funds in a separate account and shall expend such funds as agreed with Sponsor for wages (other than for Sponsor’s personnel who shall be paid by Sponsor), supplies, equipment, travel, and other operation expenses in connection with the Research Project. It is understood that funds for the Research Project which are not used in a particular quarter or during the initial one year period of this Agreement may be used in subsequent quarters or periods during the Term of this Agreement.

IV. CONSULTATION AND REPORTS

4.1  Sponsor’s designated representative for consultation and communications with the Principal Investigator shall be Bruce G. Miller or such other person as Sponsor may from time to time designate in writing to TRLLC and to the Principal Investigator.

4.2  During the Term of this Agreement, Sponsor’s representatives may consult informally with the Principal Investigator and other TRLLC representatives regarding the Research Project, both personally and by telephone. Access to work carried on by TRLLC in the course of these investigations shall be entirely under the control of the Principal Investigator but shall be made available on a reasonable basis for observation of the work.

4.3  The Principal Investigator will make up to four oral reports each year during the term of this Agreement as requested by Sponsor’s designated representative. Within ninety (90) days after termination of this Agreement, the Principal Investigator shall prepare a final report summarizing all activities undertaken and accomplishments achieved through the Research Project.

4.4  TRLLC shall prepare and maintain records regarding the Research Project, in sufficient detail and in good scientific manner, which shall be complete and accurate, and shall fully and properly reflect all work done and results achieved in the performance of the Research Project (including all data in the form required by applicable laws and regulations). Sponsor shall have the right, upon reasonable notice and during normal business hours, to inspect, copy, and to check out all research records and reports regarding the Research Project; provided that Sponsor shall maintain such records and reports and the information contained therein in confidence in accordance with applicable laws, regulations and agreements.

 

V. PUBLICATION AND ACADEMIC RIGHTS

5.1  Principal Investigator shall have the right to publish or otherwise publicly disclose information gained as the result of his research in the course of this Agreement, but, in order to avoid loss of patent rights as a result of premature public disclosure of patentable information, Principal Investigator will submit any prepublication materials and a summary of any other planned public disclosure to Sponsor for review and comment at least thirty (30) days prior to the planned submission for publication. The Principal Investigator will have all personnel participating in the Research Project submit all such prepublication materials and planned public disclosures to the Principal Investigator for submission to Sponsor as set forth in the preceding sentence. Sponsor shall notify the Principal Investigator within fifteen (15) days of receipt of such materials whether it desires to file patent applications on any inventions contained in the materials; and, if Sponsor chooses to do so, it will promptly proceed to file the patent application(s) in due course. In such case, Principal Investigator will delay publication and any other disclosure as required to ensure that such filings are made before publication or other disclosure. Principal Investigator shall have final authority to determine the scope and content of any publications, but Principal Investigator will consider in good faith suggestions by Sponsor.

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.


5.2  It is understood that, subject to Section 5.1, the Principal Investigator may discuss the research being performed under this Agreement with other investigators, but shall not reveal information which is Sponsor’s Confidential Information to the other investigators. TRLLC and Principal Investigator also agree not to disclose Sponsor’s Confidential Information to any third party and to employ reasonable safeguards to maintain Sponsor’s Confidential Information confidential and to prevent its unauthorized use, including causing TRLLC’s employees and consultants and others who will have access to Sponsor’s Confidential Information, to be bound by nondisclosure and nonuse undertakings for the protection of Sponsor’s Confidential Information. “Sponsor’s Confidential Information” means all business and technical information of a proprietary nature, whether in physical or non-physical form, of Sponsor, or any third party proprietary information in the possession of Sponsor, whether disclosed to TRLLC or Principal Investigator in written, oral or other media form, or by observation or inspection of tangible objects.

5.3 [***]

 

VI. INTELLECTUAL PROPERTY

6.1  [***] TRLLC waives all moral rights in any such Intellectual Property. “Intellectual Property” means know-how, trade secrets, inventions, works of authorship, trademarks, and all business and technical information of a proprietary nature (including, without limitation, ideas, discoveries, observations, research plans, development plans, business plans, methods, techniques, processes, protocols, test results, research results, data, analyses, specifications, formulas, formulations, and computer programs) and all physical embodiments of any of the foregoing (including, without limitation, memoranda, letters, printouts, compilations, reports, records, notebooks, lists, specifications, software, computer disks, prototypes, instruments, blueprints, diagrams, operating instructions, drawings, designs, models, proposals, databases, photographs, videos, written descriptions, invention disclosures, patent applications, patents, copyright applications, copyright registrations, trademark applications, trademark registrations, compounds, compositions and biological materials) and all rights therein throughout the world. Sponsor will have the responsibility for, and bear all expenses incurred in obtaining and maintaining protection for, and enforcing rights in, all such Intellectual Property. TRLLC will cooperate with Sponsor and will take all necessary steps to assist Sponsor in obtaining and maintaining protection for, and enforcing rights in, all such Intellectual Property, all at Sponsor’s expense. To that end, TRLLC will execute, verify and deliver such documents and perform such other acts (including providing evidence and witnesses within its control) as Sponsor may reasonably request. If Sponsor is unable because of TRLLC’s or its personnel’s or Principal Investigator’s unavailability, dissolution, mental or physical incapacity, or for any other reason, to secure the necessary signature(s) to apply for or to pursue any application for any United States or foreign patents or mask work or copyright registrations covering the Intellectual Property assigned to the Sponsor above, then TRLLC hereby irrevocably designates and appoints the Sponsor and its duly authorized officers and agents as TRLLC’s agent and attorney in fact, to act for and in TRLLC’s behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyright and mask work registrations thereon with the same legal force and effect as if executed by TRLLC. Upon termination of this Agreement, Sponsor shall retain all physical embodiments of Intellectual Property to which it obtains rights, subject to TRLLC’s right to inspect and copy records.

6.2  [***]

6.3  [***]

6.4  TRLLC also agrees that it will obtain a written agreement with each third party for research work to be performed by TRLLC for the third party, and that the agreement will include a detailed description of the research work to be performed and shall clearly limit assignment to the third party of that Intellectual Property which is conceived, developed, suggested, created, discovered or produced solely as a result of performing the research covered by the agreement. [***]

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.


VII. INSURANCE AND INDEMNIFICATION

7.1  [***]

7.2  [***]

7.3  Sponsor shall maintain, at its sole cost and expense, business and general liability coverage for the acts and omissions of itself, its officers, directors, employees and agents, including, but not limited to, covering claims, liabilities, damages and judgments which may arise out of its sponsorship of the Research Project. All such insurance shall be issued upon such forms and in such amounts that are reasonable and customary in the health care industry. Written documentation of this insurance coverage will be provided to TRLLC upon request.

7.4  Each party specifically reserves the common law right of indemnity and/or contribution which either party may have against the other. Both parties agree that upon receipt of a notice of claim or action for which indemnity may be claimed (or any threat thereof), the party receiving such notice will notify the other party promptly.

VIII. INDEPENDENT CONTRACTORS

For the purposes of this Agreement and all services to be provided hereunder, the parties shall be, and shall be deemed to be, independent contractors and not agents or employees of the other party. Neither party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on the other party, except as may be expressly provided for herein or authorized in writing.

IX. TERM AND TERMINATION

9.1  This Agreement shall commence on the Effective Date and extend until August 31, 2014, unless sooner terminated in accordance with the provisions of this Article IX or extended by mutual agreement of the parties.

9.2  This Agreement may be terminated  by th e written agreement of both parties.

9.3  This Agreement may be terminated without cause by either party. The party wanting to terminate the Agreement shall provide written notice to the other party at least one-hundred eighty (180) days prior to the date of termination, and the date of termination shall be set forth in the notice.

9.4  In the event that either party shall be in default of its material obligations under this agreement and shall fail to remedy such default within sixty (60) days after receipt of written notice thereof, this Agreement shall terminate upon expiration of the sixty (60) day period.

9.5  Termination or cancellation of this Agreement shall not affect the rights and obligations of the parties accrued prior to termination.

9.6  Any provisions of this Agreement which by their nature extend beyond termination hereof shall survive such termination.

X. ATTACHMENTS

Attachments A, B, C and D are incorporated herein and made a part hereof for all purposes. Attachment A is not intended to provide or reflect the dates of conception or reduction to practice of any invention.

XI. MATERIALS TRANSFER

11.1  [***]

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.


11.2  The Sponsor’s Material shall be used by the Principal Investigator solely in connection with the Research Project and not for any other purpose without the prior written consent of Sponsor, which consent shall not be unreasonably withheld. TRLLC shall not distribute, release, or in any way disclose Sponsor’s Material to any person or entity other than laboratory personnel under the Principal Investigator’s direct supervision.

11.3  The Receiving Party shall ensure that no one will be allowed to take or send Material to any other location, unless written permission is obtained from the Disclosing Party. The Material is made available by TRLLC and Sponsor for investigational use only in laboratory animals or  in vitro  experiments. Neither the Material, nor any chemical or biological materials treated therewith or derived therefrom, will be used in human beings.

11.4  This Agreement and the resulting transfer of Material constitute a license to use the Material solely for purposes of the Research Project. Except as otherwise provided in this Agreement, the Receiving Party agrees that nothing pursuant to this Article XI shall be deemed to grant any rights under any patents. At the request of the Disclosing Party, the Receiving Party will return all unused Material, whether or not during the Term.

11.5  Any Material provided is experimental in nature and shall be provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. THERE IS NO REPRESENTATION OR WARRANTY THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.

11.6  In no event shall the Disclosing Party be liable for any use by the Receiving Party of the Material or any loss, claim, damage or liability, of whatsoever kind or nature, which may arise from or in connection with this Agreement or the use, handling or storage of the Material.

11.7  The Receiving Party will use the Material in compliance with all laws, governmental regulations and guidelines applicable to the Material.

XII. GENERAL

12.1  This Agreement may be assigned by Sponsor in connection with an acquisition (by whatever means) by, merger with, or the sale of substantially all of its related business to, another. This Agreement may otherwise be assigned by Sponsor only with the consent of TRLLC, not to be unreasonably withheld. TRLLC may not assign this Agreement without the consent of Sponsor.

12.2  This Agreement constitutes the entire and only agreement between the parties relating to the Research Project, and all prior negotiations, representations, agreements and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by means of a written document signed by the duly authorized representatives of the parties.

12.3  Any notice required or permitted to be given under this Agreement shall be in writing and shall be deemed to be properly given on the date of personal delivery or three (3) days after deposit in the U. S. mail, sent by registered or certified mail, return receipt requested, and addressed as follows:

 

If to TRLLC:   

900 East Oxford Lane

Englewood, CO 80110

Attn: David Bar-Or, M.D.

If to Sponsor:   

DMI Life Sciences, Inc.

8400 East Crescent Parkway, Suite 600

Greenwood Village, Colorado 80111

Attn: Bruce G. Miller

or at such other addresses as may be given from time to time in accordance with the terms of this notice provision.

12.4  This Agreement shall be governed by, construed, and enforced in accordance with the internal laws of the State of Colorado.


IN WITNESS WHEREOF,  the parties have caused this Agreement to be executed by their duly authorized representatives.

 

DMI LIFE SCIENCES, INC.     TRAUMA RESEARCH, LLC
By:   /s/ Bruce G. Miller       By:   /s/ David Bar-Or, M.D.
  Bruce G. Miller       David Bar-Or, M.D.
  President & CEO       Manager

 

 

Attachment A

DESCRIPTION OF RESEARCH PROJECT

[*** (two pages omitted)]

 

 

ATTACHMENT B

[***]

 

 

ATTACHMENT C

[***]

 

 

ATTACHMENT D

[***]

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

Exhibit 10.10

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Sponsored Research Agreement

Addendum No. 4

March 17, 2014

As a result of the need to accelerate the accumulation of (1) more clinical and laboratory data in support of additional indications for the Company’s drugs currently in clinical studies and (2) to move other drugs from the Company’s drug portfolio into clinical studies, and (3) to support and expand the precise diagnostic capabilities of the ORP product to detect all forms of human disease, this addendum is entered into to expand, modify and amend the sponsored Research Agreement (the “SRA”), dated September 1, 2009, made by and between Trauma Research LLC (“TRLLC”) and Ampio Pharmaceuticals, Inc. (the “Company” or “Ampio,” formerly DMI Life Sciences, Inc., aka “Sponsor”) and, through effect of addendums, Luoxis Diagnostics, Inc. (“Luoxis”).

Capitalized terms not otherwise defined herein have the same meaning as in the SRA.

WHEREAS, the SRA was entered into as of September 1, 2009; and

WHEREAS, the SRA has been amended and modified pursuant to Addendum No. 1 thereto executed as of June 1, 2012, Addendum No. 2 thereto executed as of June 15, 2013, and Addendum No. 3 dated as of September 1, 2013; and

WHEREAS, the parties hereto (the “Parties”) desire to amend the SRA in the manner set forth below.

NOW, THEREFORE, in consideration of the mutual covenants contained herein and in accordance with Section 12.2 of the SRA, the Parties do hereby amend and revise the SRA as follows.

1.     Amendments.

1.1     Section 9.1 of the Agreement shall be amended to insert “March 31, 2019” in lieu of “August 31, 2014.”

1.2     Section 9.3 of the Agreement shall be amended to insert at the end of the Section the following language, “provided, however, no such termination shall occur prior to March 31, 2017.”

1.3     For the benefit of Ampio, the Research Project shall be modified and expanded to include the activities listed on Exhibit A hereto. In consideration thereof, Ampio shall pay to TRLLC the sum of $ 425,000 payable on March 18, 2014, $150,000 on July 1, 2014, and $150,000 on October 1, 2014.

1.4     For the benefit of Luoxis, the Research Project shall be modified and expanded to include the activities listed on Exhibit A hereto. In consideration thereof, Luoxis shall pay to TRLLC the sum of $315,000 payable on March 18, 2014, $150,000 on May 1, 2014, and $150,000 on September 1, 2014.

2.     Miscellaneous.


2.1     Except as specifically amended hereby and by prior addendums, the SRA shall continue in full force and effect.

2.2     This Amendment may be executed in any number of counterparts and, when so executed, all of such counterparts shall constitute a single instrument binding upon all Parties notwithstanding that all Parties are not signatory to the original or to the same counterpart. In the event any provision of this Amendment is determined to be invalid or unenforceable, such provision shall be deemed severed from the remainder of this Amendment and replaced with a valid and enforceable provision as similar in intent as reasonably possible to the provision so severed, and shall not cause the invalidity or unenforceability of the remainder of this Amendment.

2.3     The Parties agree to execute any additional documents reasonably necessary to effect the intention of the Parties hereto.

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

 

-2-


IN WITNESS WHEREOF, the Parties have caused this Addendum No. 4 to the SRA to be executed as of March 17, 2014.

 

Luoxis Diagnostics, Inc. Trauma Research, LLC
  /s/ Josh Disbrow /s/ David Bar-Or

Josh Disbrow

CEO

David Bar-Or, M.D.

Manager

 

Ampio Pharmaceuticals, Inc.
/s/ Michael Macaluso

Michael Macaluso

CEO

 

-3-


Exhibit A

Significantly increase the capabilities of Trauma Research to enable the following activities in support of Ampio’s commercial activities and business plan.

[***]

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

-4-


Exhibit B

Significantly increase the capabilities of Trauma Research to enable the following activities in support of Luoxis’ commercial activities and business plan.

[***]

 

 

* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

-5-