UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q/A

(Amendment No. 1)

 

x       QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED March 31, 2015

 

OR

 

o          TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM        TO       

 

COMMISSION FILE NUMBER 001-13111

 

DEPOMED, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

CALIFORNIA

 

94-3229046

(STATE OR OTHER JURISDICTION OF

 

(I.R.S. EMPLOYER

INCORPORATION OR ORGANIZATION)

 

IDENTIFICATION NUMBER)

 

7999 Gateway Boulevard, Suite 300

Newark, California 94560

(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)

 

(510) 744-8000

(REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  x No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, as defined in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer x

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  o No  x

 

The number of issued and outstanding shares of the Registrant’s Common Stock, no par value, as of May 8, 2015 was 59,963,351.

 

 

 



 

Explanatory Note

 

Depomed, Inc. (the “Company”) is filing this Amendment No. 1 (this “Amendment”) to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission (the “Commission”) on May 11, 2015 (the “Form 10-Q”). The sole purpose of this Amendment is to file revised versions of Exhibits 10.1, 10.2, 10.3, 10.4 and 10.5 (the “Exhibits”) to the Form 10-Q in response to communications from the Staff of the Commission regarding a confidential treatment request made by the Company with respect to certain portions of the Exhibits. 

 

Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment restates in its entirety Item 6 of the Form 10-Q and contains new certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, which are filed herewith. Because no financial statements have been included in this amendment and this amendment does not contain or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4 and 5 of such certifications have been omitted.

 

This Amendment should be read in conjunction with the Form 10-Q, which continues to speak as of the date of the Form 10-Q. Except as specifically noted above, this Amendment does not modify or update disclosures in the Form 10-Q. Accordingly, this Amendment does not reflect events occurring after the filing of the Form 10-Q or modify or update any related or other disclosures.

 

2



 

ITEM 6. EXHIBITS

 

 

(a)

Exhibits

 

 

3.1

(1)

Amended and Restated Articles of Incorporation

 

3.2

(2)

Certificate of Amendment to Amended and Restated Articles of Incorporation

 

3.3

(3)

Certificate of Determination of Series RP Preferred Stock of the Company

 

3.4

(4)

Bylaws, as amended

 

+10.1

(*)

Note Purchase Agreement dated March 12, 2015 among the Company and Deerfield Private Design Fund III, L.P., Deerfield Partners, L.P., Deerfield International Master Fund, L.P., Deerfield Special Situations Fund, L.P., Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., BioPharma Secured Investments III Holdings Cayman LP, Inteligo Bank Ltd. and Phemus Corporation and Deerfield Private Design Fund III, L.P., as collateral agent

 

+10.2

(*)

Security Agreement dated April 2, 2015 between the Company and Deerfield Private Design Fund III, L.P., as collateral agent

 

+10.3

(*)

Assignment and Consent dated January 13, 2015 between the Company and Grünenthal GmbH related to the License Agreement (U.S.) dated January 13, 2015 between Grünenthal GmbH and Janssen Research and Development

 

+10.4

(*)

Transitional Supply Agreement dated April 2, 2015 between the Company, Janssen Ortho LLC and Janssen Pharmaceuticals, Inc.

 

+10.5

(*)

Supply Agreement dated April 2, 2015 between the Company and Noramco, Inc.

 

31.1

(*)

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of James A. Schoeneck

 

31.2

(*)

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of August J. Moretti

 

32.1

(**)

Certification pursuant to 18 U.S.C. Section 1350 of James A. Schoeneck

 

32.2

(**)

Certification pursuant to 18 U.S.C. Section 1350 of August J. Moretti

 

101

(***)

Interactive Data Files pursuant to Rule 405 of Regulation S-T

 


 

 

 

(1)

Incorporated by reference to the Company’s registration statement on Form SB-2 (File No. 333-25445)

 

 

 

(2)

Incorporated by reference to the Company’s Form 10-K filed on March 31, 2003

 

 

 

(3)

Incorporated by reference to the Company’s Form 10-Q filed on May 10, 2005

 

 

 

(4)

Incorporated by reference to the Company’s Form 8-K filed on April 19, 2005

 

 

 

*

Filed herewith

 

 

 

+

Confidential treatment requested

 

 

 

**

Previously furnished with the Form 10-Q

 

 

 

***

Previously filed with the Form 10-Q

 

3



 

SIGNATURES

 

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 thereunto duly authorized.

 

Date: December 18, 2015

DEPOMED, INC.

 

 

 

 

 

/s/ James A. Schoeneck

 

James A. Schoeneck

 

President and Chief Executive Officer

 

 

 

 

 

/s/ August J. Moretti

 

August J. Moretti

 

Chief Financial Officer

 

4


Exhibit 10.1

 

CERTAIN MATERIAL (INDICATED BY [***]) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

NOTE PURCHASE AGREEMENT

 

THIS NOTE PURCHASE AGREEMENT (this “ Agreement ”), dated as of March 12, 2015, is made and entered into by and between, DEPOMED, INC. , a California corporation, the purchasers party hereto from time to time, and DEERFIELD PRIVATE DESIGN FUND III, L.P. , as collateral agent.

 

BACKGROUND STATEMENT

 

A.                                     The Borrower has requested that the Purchasers purchase an aggregate principal amount of $575,000,000 of the Borrower’s senior secured notes, each substantially in the form of Exhibit B hereto (the “ Notes ”) pursuant to and in accordance with the terms and conditions hereof.

 

B.                                     The Purchasers are willing to purchase the Notes described above upon the terms and subject to the conditions set forth in this Agreement.

 

AGREEMENT

 

NOW, THEREFORE , in consideration of the premises, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and in order to induce the Purchasers to purchase the notes described herein, the parties hereto hereby agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

1.1                                Defined Terms .  In addition to the words and terms defined elsewhere in this Agreement, the following terms when used herein have the following respective meanings:

 

ACH Indebtedness ” means Indebtedness incurred in the ordinary course of business arising in connection with any automated clearinghouse transfers of funds or other payment processing service.

 

Acquisition ” means the acquisition of the “Purchased Assets” (as defined in the Acquisition Agreement) or any substantial portion thereof.

 

Acquisition Agreement ” means that certain Asset Purchase Agreement, dated as of January 15, 2015, between Janssen Pharmaceuticals, Inc. and the Borrower, without giving effect to any amendments, modifications or supplements thereto that are not approved by the Required Purchasers (other than amendments, modifications or supplements that, individually or in the aggregate, could not reasonably be expected to be materially adverse to the Purchasers; it being

 

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

 



 

agreed that any change in the Purchase Price (as defined in the Acquisition Agreement as of the date hereof) that is greater than or equal to 5% of the total consideration set forth in the Acquisition Agreement as of the date hereof will be deemed to be materially adverse to the Purchasers).

 

Acquisition Subsidiary ” means a newly formed direct Wholly Owned Subsidiary of the Borrower.

 

Adjusted EBITDA ” means, with respect to any Person for any Test Period, EBITDA for such Person plus (i) to the extent deducted in determining Consolidated Net Income for such Person for such Test Period, (A) fees and expenses directly incurred or paid in connection with (x) the Acquisition and the transactions contemplated by this Agreement, (y) any other Permitted Acquisition or Investment and (z) to the extent permitted hereunder, issuances or incurrence of Indebtedness, issuances of Capital Stock or refinancing transactions and modifications of instruments of Indebtedness, (B) any non-recurring charges, costs, fees and expenses directly incurred or paid directly as a result of discontinued operations (other than such charges, costs, fees and expenses to the extent constituting losses arising from such discontinued operations), (C) restructuring charges or reserves, [***] the Acquisition, a Permitted Acquisition or a Permissible Change of Control, as applicable, in each case [***] of the Acquisition, such Permitted Acquisition or such Permissible Change of Control [***] as the case may be, calculated as though [***] during such period from the Acquisition, such Permitted Acquisition or such Permissible Change of Control, as the case may be; provided that [***] pursuant to this clause (D) to the extent [***] subject to the last paragraph of Section 5.2, [***] of the Borrower, and (3) the [***] pursuant to this clause (D) shall not exceed the amount of [***] publicly disclosed by the Borrower or the [***] (if applicable) in any filings with the SEC with respect to the Acquisition, such Permitted Acquisition or such Permissible Change of Control, as the case may be minus (ii) to the extent included in Consolidated Net Income for such Person for such Test Period, any non-recurring income or gains directly as a result of discontinued operations.

 

Affiliate ” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such first Person or any of its Subsidiaries.  The term “control” means (a) the power to vote ten percent (10%) or more of the Capital Stock of a Person having ordinary voting power, or (b) the possession, directly or indirectly, of any other power to direct or cause the direction of the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise.  The terms “controlling” and “controlled” have meanings correlative thereto.  Notwithstanding the foregoing, neither the Collateral Agent nor any Purchaser shall be deemed an “Affiliate” of any Consolidated Entity.

 

Agreement ” means this Note Purchase Agreement and all schedules, annexes and exhibits hereto.

 

Applicable Percentage ” means 50%, provided that during any time period during which Deerfield and its Affiliates (i) beneficially own more than 20% of the Common Stock (on a fully diluted basis) or (ii) beneficially own more than 10% of the Common Stock (on a fully diluted basis) and one or more the board directors of the Borrower was appointed by, or is a representative of, Deerfield and its Affiliates, Applicable Percentage shall mean 70%.

 

Asset Disposition ” means any sale, license, assignment, lease, conveyance, transfer or other disposition by any Consolidated Entity of all or any of its assets, business or other properties (including Capital Stock of Subsidiaries), other than (i) sales of inventory and the sale or discount of accounts receivables in the ordinary course of business, (ii) non-exclusive licenses in the ordinary course of business, (iii) sales, licenses, assignments, leases, conveyances, transfers or other dispositions to a Credit Party, (iv) Permitted Liens, (v) dispositions of damaged, expired, short-dated, worn-out or obsolete equipment, inventory or assets in the ordinary course of business, (vi) leases or subleases to third Persons in the ordinary course of business that do not interfere in any material respect with the business of the Consolidated Entities, (vii) dispositions of cash and Cash Equivalents, (viii)[***], (ix) the abandonment of intellectual property rights in the ordinary course of business, (x) the unwinding, settlement or termination of any obligations or rights under or in respect of any Hedging Agreements, (xi) the issuance or sale of Capital Stock by any Subsidiary to any Credit Party or any Wholly Owned Subsidiary of a Credit Party, and (xii) the licensing of Intellectual Property in connection with

 

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

 

2



 

the research, development and commercialization of any compound, product or Intellectual Property of such Consolidated Entity or the sale, manufacture and distribution of any compound or products of such Consolidated Entity (including in connection with the settlement of any litigation or other claims), provided , however , that notwithstanding anything to the contrary, an Excluded License shall constitute an Asset Disposition.

 

Asset Disposition Proceeds ” means, as of any date of determination, the aggregate cash proceeds (net of (i) reasonable fees and out-of-pocket expenses payable in connection therewith, (ii) taxes paid or reasonably estimated to be payable as a result thereof, (iii) the amount of any reserves established to fund contingent expenses and liabilities reasonably estimated to be payable, and (iv) the amount of all payments of Indebtedness required to be made as a result of Asset Dispositions (other than repayments of the Notes and Indebtedness that is subordinated to the Notes)) received by the Consolidated Entities after the Purchase Date in connection with Asset Dispositions, including any cash proceeds received by any Consolidated Entity in connection with any Deferred Acquisition Consideration.

 

Available Additional Amount ” means, as of any time of determination, an amount equal to (i) [***] minus (ii) the aggregate amount used prior to such time of determination for any of the following: (A) [***] and (B) [***].

 

Bankruptcy Code ” means Title 11 of the United States Code and any successor statute or statutes having substantially the same function.

 

Borrower ” means Depomed, Inc., a California corporation, and all of its permitted successors and assigns.

 

Business Day ” means any day of the year on which banks are open for business in New York, New York.

 

Capital Lease ” means any lease or similar arrangement which is of a nature that payment obligations of the lessee or obligor thereunder at the time are or should be capitalized and shown as liabilities (other than current liabilities) upon a balance sheet of such lessee or obligor prepared in accordance with GAAP.

 

Capital Lease Obligations ” means, with respect to any Capital Lease, the amount of the obligation of the lessee thereunder that would, in accordance with GAAP, appear on a balance sheet of such lessee with respect to such Capital Lease.

 

Capital Stock ” means (i) with respect to any Person that is a corporation, any and all shares, interests or equivalents in capital stock (whether voting or nonvoting, and whether common or preferred) of such corporation, and (ii) with respect to any Person that is not a corporation, any and all partnership, membership, limited liability company or other equity interests of such Person; and in each case, any and all warrants, rights or options to purchase any of the foregoing (but excluding any Indebtedness convertible into, or exchangeable for Capital Stock).

 

Cash Equivalents ” means (i) securities issued or unconditionally guaranteed or insured by the United States of America or any agency or instrumentality thereof, backed by the full faith

 

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

 

3



 

and credit of the United States of America and maturing within one year from the date of acquisition, (ii) commercial paper issued by any Person organized under the laws of the United States of America, maturing within 360 days from the date of acquisition and, at the time of acquisition, having a rating of at least A-1 or the equivalent thereof by Standard & Poor’s Ratings Services or at least P-1 or the equivalent thereof by Moody’s Investors Service, Inc., or F-1 or better by Fitch Investor Services, (iii) time deposits and certificates of deposit maturing within 360 days from the date of issuance and issued by a bank or trust company organized under the laws of the United States of America or any state thereof (A) that has combined capital and surplus of at least $500,000,000 or (B) that has (or is a subsidiary of a bank holding company that has) a long-term unsecured debt rating of at least A or the equivalent thereof by Standard & Poor’s Ratings Services or at least A2 or the equivalent thereof by Moody’s Investors Service, Inc. or A or better by Fitch Investor Services, and (iv) money market funds that are SEC registered 2a-7 eligible only, have assets in excess of $1,000,000,000, offer a daily purchase/redemption feature and seek to maintain a constant share price; provided that the Credit Parties will invest only in ‘no-load’ funds which have a constant $1.00 net asset value target.

 

Change in Law ” means the occurrence, after the date of this Agreement, of any of the following: (i) the adoption or taking effect of any law, rule, regulation or treaty by any Governmental Authority, (ii) any change in any law, rule, regulation or treaty or in the administration, interpretation, implementation or application thereof by any Governmental Authority or (iii) the making or issuance of any request, rule, guideline or directive (whether or not having the force of law) by any Governmental Authority; provided that, notwithstanding anything herein to the contrary, (x) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (y) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel Committee on Banking Supervision (or any successor or similar authority) or the United States or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to be a Change in Law, regardless of the date enacted, adopted or issued.

 

Code ” means the Internal Revenue Code of 1986 or any successor federal tax code.  Any reference to any provision of the Code shall also include the income tax regulations promulgated thereunder, whether final, temporary or proposed.

 

Collateral Agent ” means Deerfield, in its capacity as Collateral Agent appointed under Section 8.1 and any other Security Documents, and its successors and permitted assigns in such capacity.

 

Commitment ” means, with respect to any Purchaser, the commitment of such Purchaser to purchase Notes on the Purchase Date in an aggregate principal amount up to the amount set forth opposite such Purchaser’s name on Exhibit A , as such amount may be reduced from time to time pursuant to the terms hereof.

 

Common Stock ” means the common stock, no par value per share, of the Borrower.

 

Consolidated Entities ” means the Borrower and its Subsidiaries.

 

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

 

4



 

Consolidated Net Income ” means, with respect to any Person for any Test Period, net income (or loss) for such Person and its Subsidiaries for such Test Period, determined on a consolidated basis in accordance with GAAP (after deduction for minority interests); provided that, in making such determination, there shall be excluded (i) the net income of any other Person that is not a Subsidiary of such Person (or is accounted for by such Person by the equity method of accounting) except to the extent of actual payment of cash dividends or distributions by such Person to such Person or one of its Subsidiaries during such Test Period, (ii) the net income (or loss) of any other Person acquired by, or merged with, such Person or any of its Subsidiaries for any period prior to the date of such acquisition or merger, and (iii) the net income of any Subsidiary of such Person to the extent that the declaration or payment of dividends or similar distributions by such Subsidiary of such net income is not at the time permitted by operation of the terms of its charter, certificate of incorporation or formation or other constituent document or any agreement or instrument (other than a Credit Document) or Requirement of Law applicable to such Subsidiary.

 

Controlled Group ” means all members of a controlled group of corporations and all trades or businesses (whether or not incorporated) under common control that, together with the Borrower, are treated as a single employer under Section 414 of the Code.

 

Convertible Notes ” means the 2.50% Convertible Senior Notes due 2021 issued by the Borrower pursuant to the Indentures.

 

Costs ” has the meaning set forth in Section 9.2 .

 

Credit Documents ” means and collectively refer to this Agreement, the Notes, the Security Documents, the Guaranty and any and all other agreements between a Credit Party and the Collateral Agent or the Purchasers in connection with this Agreement.

 

Credit Parties ” means the Borrower and the Subsidiary Guarantors.

 

Cumulative Excess EBITDA ” means, for any fiscal year of the Borrower, the greater of (i) [***] and (ii) [***].  Notwithstanding the foregoing, Cumulative Excess EBITDA for the [***] shall be deemed to be [***].

 

Deerfield ” means Deerfield Private Design Fund III, L.P.

 

Default ” means any Event of Default or any event that with the giving of notice, lapse of time, or both, would constitute an Event of Default.

 

Default Rate ” has the meaning set forth in Section 2.3(c) .

 

Deferred Acquisition Consideration ” means any purchase price adjustments, royalty, earn-out, Milestone Payments, indemnity, contingent or other deferred payment payments of a similar nature (including any non-compete payments and consulting payments) payable in connection with any Permitted Acquisition or other acquisition or disposition permitted under this Agreement.

 

Depo DR ” means Depo DR Sub, LLC, a Wholly Owned Subsidiary of the Borrower.

 

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

 

5



 

Deposit Account ” has the meaning given to it in Article 9 of the UCC.

 

Deposit Account Control Agreement ” means any agreement establishing the Collateral Agent’s control (as defined in the UCC) of any Deposit Account.

 

Disqualified Capital Stock ” means any Capital Stock that is not Qualified Capital Stock.

 

Dollar ” or “ $ ” means dollars in lawful currency of the United States of America.

 

EBITDA ” means, with respect to any Person for any Test Period, Consolidated Net Income for such Person for such Test Period (excluding for the Borrower, net income attributable to Depo DR, except to the extent distributed to the Borrower) plus (i) to the extent deducted in determining Consolidated Net Income for such Person for such Test Period, (A) interest expense, (B) provision for taxes paid or accrued, (C) depreciation and amortization, (D) non-cash expenses related to stock based compensation, (E) extraordinary non-cash expenses or losses incurred other than in the ordinary course of business, (F) any unrealized losses in respect of Hedge Agreements, and (G) adjustments relating to purchase price allocation accounting, minus (iii) to the extent included in Consolidated Net Income for such Person for such Test Period, (A) interest income (to the extent not netted against interest expense in the calculation of interest expense), (B) income tax credits and refunds (to the extent not netted from tax expenses), (C) extraordinary non-cash income or gains realized other than in the ordinary course of business, and (D) any unrealized income or gains in respect of Hedge Agreements (to the extent not included in clause (i)(F)) above or netted against interest expense in the calculation of interest expense).  For the avoidance of doubt, the foregoing additions to, and subtractions from, for the Borrower shall not give effect to any items attributable to Depo DR Sub.

 

Environmental Law ” means any federal, state or local law, statute, ordinance, rule, regulation, permit, license, approval, interpretation, order, guidance or other legal requirement (including any subsequent enactment, amendment or modification) relating to the protection of human health or the environment, including, but not limited to, any requirement pertaining to the manufacture, processing, distribution, use, treatment, storage, disposal, transportation, handling, reporting, licensing, permitting, investigation or remediation of materials that are or may constitute a threat to human health or the environment.

 

ERISA ” means the Employee Retirement Income Security Act of 1974.

 

Event of Default ” has the meaning specified in Article VII .

 

Excess EBITDA ” means, for any fiscal year of the Borrower, the product of (i) EBITDA of the Borrower for such fiscal year, minus [***] and (ii) [***].  Excess EBITDA for any fiscal year may be a negative number.

 

Exchange Act ” means the Securities Exchange Act of 1934, as amended, including the rules and regulations promulgated thereunder.

 

Excluded Account ” means (i) any accounts the funds in which are used solely for the payment of wages, salaries, worker’s compensation and similar expenses and accounts the funds in which consist solely of funds held by a Credit Party in trust for any director, officer or

 

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

 

6



 

employee of, or any employee benefit plan maintained by, any Credit Party, (ii) (x) escrow accounts and (y) trust accounts, in each case entered into in the ordinary course of business and consistent with prudent business practice conduct where the applicable Credit Party holds the funds exclusively for the benefit of an unaffiliated third party, (iii) deposit accounts the daily balance in which does not at any time exceed [***] for any such account or [***] for all such accounts, (iv) any deposit account that is a zero-balance disbursement account, (v) deposit and investment accounts (A) subject to a control agreement in favor of a lender or the administrative or collateral agent under a working capital or revolving credit facility permitted under Section 6.2(iv)  and (B) over which the Collateral Agent has a second lien, (vi) deposit accounts securing treasury and cash management services, letters of credit and business credit card obligations permitted under Section 6.2 , and (vii) deposit and securities accounts held outside the United States.

 

Excluded Domestic Holdco ” means a Subsidiary that is a U.S. Person and substantially all the assets of which consist of Capital Stock issued by one or more “controlled foreign corporations” as such term is defined in Section 957 of the Code.

 

Excluded Foreign Subsidiary ” means (i) any Excluded Domestic Holdco, and (ii) any Foreign Subsidiary that is a “controlled foreign corporation” as such term is defined in Section 957 of the Code or that is owned by a “controlled foreign corporation,” except in either case if such Excluded Foreign Subsidiary has pledged two-thirds or more of its voting Capital Stock to secure any Indebtedness (other than the Notes) of a Credit Party or any other Subsidiary which is a U.S. Person.

 

Excluded License ” means (i) any exclusive rights in a particular geography or for a particular indication to sell or commercialize any approved or currently-marketed pharmaceutical product or medical device (other than any co-marketing, distribution or similar agreement in which a Consolidated Entity participates in the net sales (or profits thereof) of the applicable product or medical device) or (ii) an exclusive license or sublicense of any Intellectual Property that is tantamount to a sale of substantially all rights to such Intellectual Property in a particular geography or field of use because it conveys to the licensee or sublicensee exclusive rights to practice such Intellectual Property in the applicable geography or field of use for consideration that is not based upon future development or commercialization of products (other than pursuant to so-called earn-out payments) or services by the licensee or sublicensee (other than transition services), such as, for example, consideration of only upfront advances or initial license fees or similar payments in consideration of such rights, with no anticipated subsequent payments or de minimis payments to any Consolidated Entity (other than pursuant to so-called earn-out payments or transition services).

 

Excluded Subsidiary ” means (i) Depo DR, (ii) any Subsidiary that is prohibited by any applicable law or by any contractual obligation existing on the date of acquisition or formation of such Subsidiary (provided such contractual obligation was not entered into in contemplation thereof) from guaranteeing the Obligations or any Subsidiary that would require consent, approval, license or authorization of any Governmental Authority in order to guarantee the Obligations unless such consent, approval, license or authorization has been received or can be obtained by the Subsidiary through the use of commercially reasonable efforts (including, without limitation, any consent, approval or authorization required in connection with the White

 

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

 

7



 

Wash Requirements), (iii) any Foreign Subsidiary for which the providing of the guarantee under the Guaranty or providing collateral under the Security Documents could reasonably be expected to result in any violation or breach of, or conflict with, fiduciary duties of such Subsidiary’s officers, directors or managers, (iv) any Subsidiary that has assets of less than [***], and (v) those Foreign Subsidiaries as to which the Borrower and the Required Purchasers shall reasonably determine in writing that the costs of providing a joinder to the Guaranty by such Subsidiary are excessive in relation to the value to be afforded thereby.

 

Excluded Taxes ” means any of the following Taxes imposed on or with respect to a Recipient or required to be withheld or deducted from a payment to a Recipient, (a) Taxes imposed on or measured by net income (however denominated), franchise Taxes, and branch profits Taxes, in each case, (i) imposed by the United States or as a result of such Recipient being organized under the laws of, or having its principal office or, in the case of any Purchaser, its applicable lending office located in, the jurisdiction imposing such Tax (or any political subdivision thereof) or (ii) that are Other Connection Taxes, (b) in the case of a Purchaser, U.S. federal withholding Taxes imposed on amounts payable to or for the account of such Purchaser with respect to an applicable interest in a Note or Commitment pursuant to a law in effect on the date on which (i) such Purchaser acquires such interest in the Note or Commitment (other than pursuant to an assignment request by the Borrower under Section 2.14 ) or (ii) such Purchaser changes its lending office, except in each case to the extent that, pursuant to Section 2.11, amounts with respect to such Taxes were payable either to such Purchaser’s assignor immediately before such Purchaser became a party hereto or to such Purchaser immediately before it changed its lending office, (c) Taxes attributable to such Recipient’s failure to comply with Section 2.11(c)  (other than as a result of Change in Law) or (d) any U.S. federal withholding Taxes imposed under FATCA.

 

FATCA ” means Sections 1471 through 1474 of the Code (or any amended or successor version), any current or future regulations or official interpretations thereof, any agreement entered into pursuant to Section 1471(b)(1) of the Code and any intergovernmental agreement between the United States and any other jurisdiction to implement Sections 1471 through 1474 of the Code.

 

FDA ” means the U.S. Food and Drug Administration.

 

Foreign Purchaser ” means each Purchaser (or if the Purchaser is a disregarded entity for U.S. federal income tax purposes, the Person treated as the owner of the assets of such Purchaser for U.S. federal income tax purposes) that is not a U.S. Person.

 

Foreign Subsidiary ” means any Subsidiary organized in a jurisdiction outside the United States.

 

Future Acquisition Subsidiary ” means a Subsidiary that is (i)(A) acquired in a Permitted Acquisition, or (B) created for purposes of consummating a Permitted Acquisition (for clarity, such Subsidiary shall not, immediately before such Permitted Acquisition, own or hold any assets), and (ii) obligated with respect to Indebtedness incurred under Section 6.2(x) .

 

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

 

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GAAP ” means generally accepted accounting principles, as recognized by the American Institute of Certified Public Accountants, as modified pursuant to Section 1.2 below.

 

Governmental Authority ” means any nation or government, any state, department, agency or other political subdivision thereof, and any entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to any government.

 

Guaranty ” means a guaranty agreement made by the Subsidiary Guarantors in favor of the Collateral Agent and the Purchasers substantially in the form attached as Exhibit E hereto .

 

Hazardous Material ” means any substance or material meeting any one or more of the following criteria: (i) it is or contains a substance designated as a hazardous waste, hazardous substance, pollutant, contaminant or toxic substance under any Environmental Law; (ii) it is toxic, explosive, corrosive, ignitable, infectious, radioactive, mutagenic or otherwise hazardous, (iii) its presence requires investigation or remediation under an Environmental Law or common law; (iv) it constitutes a danger, nuisance, trespass or health or safety hazard to persons or property; or (v) it is or contains, without limiting the foregoing, petroleum hydrocarbons.

 

Hedge Agreement ” means any agreement, device or arrangement providing for payments which are related to fluctuations of interest rates, exchange rates, forward rates, or equity prices, including dollar-denominated or cross-currency interest rate exchange agreements, forward currency exchange agreements, interest rate cap or collar protection agreements, forward rate currency or interest rate options, puts and warrants, and any agreement pertaining to equity derivative transactions (for example, equity or equity index swaps, options, caps, floors, collars and forwards).

 

Indebtedness ” means, for any Person, without duplication, (i) obligations of such Person for borrowed money; (ii) obligations of such Person evidenced by bonds, debentures, notes or other similar instruments; (iii) obligations of such Person in respect of the deferred purchase price of property or services (other than trade payables incurred in the ordinary course of business on terms customary in the trade, operating lease and license obligations incurred in the ordinary course of business that are not capitalized, deferred compensation and severance, pension, health and welfare retirement and equivalent benefits to current or former employees, directors or managers of such Person and its Subsidiaries, and any Deferred Acquisition Consideration payable in connection with the Acquisition, any acquisition effected prior to the date hereof or in connection with any Permitted Acquisition) which in accordance with GAAP would be required to be shown as a liability; (iv) obligations of such Person under any conditional sale or other title retention agreement relating to property acquired by such Person; (v) Capital Lease Obligations of such Person; (vi) obligations, contingent or otherwise, of such Person in respect of letters of credit, acceptances or similar extensions of credit (whether or not drawn upon and in the stated amount thereof); (vii) guaranties by such Person of the type of indebtedness described in clauses (i) through (vi) above; (viii) all indebtedness of a third party secured by any Lien on property owned by such Person, whether or not such indebtedness has been assumed by such Person; (ix) all Disqualified Capital Stock of such Person; (x) the principal balance outstanding under any asset securitization programs, synthetic leases, sale and leaseback transactions or other similar obligations arising with respect to any other transaction which is the functional equivalent of or takes the place of borrowing but which does not

 

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

 

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constitute a liability on the consolidated balance sheet of such Person and its subsidiaries; and (xi) net termination obligations under any Hedge Agreement (other than to the extent such obligations can be settled in shares of Qualified Capital Stock of such Person).

 

Indemnified Taxes ” means (a) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made by or on account of any obligation of any Credit Party under any Credit Document and (b) to the extent not otherwise described in (a), Other Taxes.

 

Indentures ” means the Senior Indenture and the First Supplemental Indenture thereto, each dated as of September 9, 2014 and between the Borrower and The Bank of New York Mellon Trust Company, N.A., as trustee.

 

Intellectual Property ” means (i) all inventions (whether or not patentable and whether or not reduced to practice), all improvements thereto, and all patents, patent applications, and patent disclosures, together with all reissues, continuations, continuations-in-part, divisions, revisions, extensions, and reexaminations thereof, (ii) all trademarks, service marks, trade dress, logos, trade names, and corporate names, together with all goodwill associated therewith, and all applications, registrations, and renewals in connection therewith, (iii) all copyrightable works and all copyrights (registered and unregistered), (iv) all trade secrets and confidential information (including financial, business and marketing plans and customer and supplier lists and related information), (v) all computer software and software systems (including data, databases and related documentation), (vi) all Internet web sites and domain names, (vii) all technology, know-how, processes and other proprietary rights and (viii) all licenses or other agreements to or from third parties regarding any of the foregoing.

 

Interest Rate ” means, as of any Interest Rate Determination Date, the per annum interest rate equal to the lesser of (i)(A) for the period from the Purchase Date to the third anniversary of the Purchase Date, 11.95% and (B) thereafter, 12.95% and (ii) the sum of (A) 9.75% and (B) the greater of (1) the LIBOR Rate as of such date and (2) 1.00%.

 

Interest Rate Determination Date ” means (i) the Purchase Date and (ii) the first Business Day of each fiscal quarter ( i.e. January, April, July and October), commencing with the first such date following the Purchase Date.

 

Investments ” has the meaning set forth in Section 6.4 .

 

Landlord Agreement ” means an agreement pursuant to which the lessor of the corporate headquarters of the Borrower provides (i) the Collateral Agent with access to personal property of the Consolidated Entities located in the facility leased by the Borrower from such lessor and a reasonable time to sell and dispose of the inventory from such location and (ii) waives or subordinates any personal property liens against the assets of the Credit Parties to and for the benefit of the Collateral Agent and the Purchasers.

 

LIBOR Rate ” means, as of any Interest Rate Determination Date, the rate per annum equal to (i) the rate of interest appearing on Reuters Screen LIBOR01 Page (or any successor page) for dollar deposits or (ii) if no such rate is available, the rate of interest determined by the Collateral Agent to be the rate or the arithmetic mean of rates at which dollar deposits in

 

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

 

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immediately available funds are offered to first-tier banks in the London interbank Eurodollar market, in each case under clause (i) or (ii) above at approximately 11:00 a.m., London time, on such Interest Rate Determination Date for a period of three months.

 

Lien ” means any interest in property securing an obligation owed to, or claim by, a Person other than the owner of such property, whether such interest arises by virtue of contract, statute or common law, including the lien or security interest arising from a mortgage, security agreement, pledge, lease, conditional sale, consignment or bailment for security purposes or from attachment, judgment or execution and any easement, covenant, restriction, condition, reservation, encroachment, right-of-way, lease or other title exception or encumbrance affecting any property.

 

Major Transaction ” means:

 

(i)                                      a consolidation, merger, exchange of shares, recapitalization, reorganization, business combination or any other event (A) following which the holders of Common Stock immediately preceding such consolidation, merger, exchange, recapitalization, reorganization, combination or event either (x) no longer hold a majority of the shares of Common Stock or (y) no longer have the ability to elect a majority of the board of directors of the Borrower or (B) as a result of which shares of Common Stock shall be changed into (or the shares of Common Stock become entitled to receive) the same or different number of shares of the same or another class or classes of stock or securities of another entity other than a merger effected solely for purposes of changing the Borrower’s state of incorporation or domicile;

 

(ii)                                   the sale or transfer in one or a series of transactions of (A) all or substantially all of the assets of the Borrower on a consolidated basis to any Person other than a Wholly Owned Subsidiary Guarantor or (B) assets of the Consolidated Entities (other than Depo DR) for a purchase price equal to more than 50% of the Market Cap (as defined below) of the Borrower;

 

(iii)                                any Person or group, other than the Borrower and its Subsidiaries or any employee benefit plan of the Borrower or its Subsidiaries, files a Schedule 13D or Schedule TO (or any successor schedule, form or report) pursuant to the Exchange Act disclosing such Person has become the beneficial owner of shares with a majority of the total voting power of all outstanding voting securities that are entitled to vote generally in the election of the Borrower’s board of directors;

 

(iv)                               the liquidation, bankruptcy, insolvency, dissolution or winding up (or the occurrence of an analogous proceeding) affecting the Borrower; or

 

(v)                                  the shares of Common Stock cease to be listed on a Principal Market.

 

For purposes of clause (ii) above, “ Market Cap ” shall mean, as of the date of the definitive agreements for such sale or transfer, the product of (x) the number of issued and outstanding shares of Common Stock on such date multiplied by (y) the per share closing price of the Common Stock on such date.  From and after the occurrence of a Permissible Change of Control, Market Cap shall be (A) if the Public Successor shall have assumed or guaranteed the

 

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

 

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Obligations, based on the common stock of the Public Successor, and (B) otherwise, the Market Cap of the Borrower immediately before the occurrence of such Permissible Change of Control.

 

Material Adverse Effect ” means (i) a material adverse change in, or a material adverse effect on, the operations, business, assets, properties, liabilities (actual or contingent) or condition (financial or otherwise) of the Consolidated Entities, taken as a whole; (ii) any material adverse effect on the rights and remedies, individually or in the aggregate, of the Collateral Agent or the Purchasers under the Credit Documents, or the ability of any the Credit Parties, taken as a whole, to perform the Obligations; or (iii) a material adverse effect upon the validity or enforceability against any Credit Party of the Credit Documents to which it is a party.

 

Material Contract ” means (i) upon completion of the Acquisition, the License Agreement (U.S.), effective as of January 13, 2015, by and among Grünenthal GmbH, Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC; (ii) the [***], (iii) each material supply agreement, manufacturing agreement, agreement to in-license Intellectual Property and similar agreement related to Material Products; (iv) the Indentures; and (v) each “material contract” (within the meaning of Item 601(b)(10) of Regulation S-K under the Securities Act but excluding any employment or management contracts or compensatory plan, contracts or other arrangements described in Item 601(b)(10)(iii) of Regulation S-K under the Securities Act and excluding any real property leases) to which any Consolidated Entity is a party.

 

Material Products ” means, as of any date of determination, [***] (in each case so long as such a Consolidated Entity continues to own the Intellectual Property relating to, and sell or market, such product) and any other pharmaceutical product or medical device sold by any Consolidated Entity that has net sales in excess of [***] for the Test Period most recently ended (as determined on a consolidated basis in accordance with GAAP).

 

Maturity Date ” means the seventh anniversary of the Purchase Date.

 

Milestone Payments ” means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Capital Stock acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

 

Mortgage ” means any mortgage, deed of trust, deed to secure debt, collateral assignment of lease or similar agreement or instrument pursuant to which any Credit Party grants in favor of the Collateral Agent, or a trustee for the benefit of the Collateral Agent, a security interest in and Lien upon any fee or leasehold interest in any real property owned by any Credit Party.

 

Multiemployer Plan ” means any “multiemployer plan” within the meaning of Section 4001(a)(3) of ERISA.

 

Net Sales ” means, as of the end of any fiscal quarter, the line item “product sales” (which includes a reduction for product sales allowances) of the Consolidated Entities for the

 

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

 

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prior twelve months, determined consistent with past practice on a consolidated basis in accordance with GAAP.

 

Notes ” has the meaning set forth in the Background Statement above.

 

Obligations ” means (i) the Notes and all other loans, advances, indebtedness, liabilities, obligations, covenants and duties owing, arising, due or payable from any Consolidated Entity to the Collateral Agent or the Purchasers of any kind or nature, present or future, arising under this Agreement or any of the other Credit Documents, whether direct or indirect (including those acquired by assignment), absolute or contingent, primary or secondary, due or to become due, now existing or hereafter arising and however acquired; and (ii) all interest (including to the extent permitted by law, all post-petition interest), charges, expenses, fees, attorneys’ fees and any other sums payable by any Consolidated Entity to the Collateral Agent or the Purchasers under this Agreement or any of the other Credit Documents.

 

OFAC ” means the U.S. Department of the Treasury’s Office of Foreign Assets Control and any successor thereto.

 

Other Connection Taxes ” means, with respect to any Recipient, Taxes imposed as a result of a present or former connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising solely from such Recipient having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any transactions pursuant to or enforced any Credit Document, or sold or assigned an interest in any Note or other Credit Document).

 

Other Taxes ” means all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes that arise from any payment made under, from the execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest under, or otherwise with respect to, any Credit Document, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment (other than an assignment made at the request of the Borrower pursuant to Section 2.14 ).

 

PATRIOT Act ” means the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT Act of 2001) and any successor statute.

 

PBGC ” means the Pension Benefit Guaranty Corporation and any successor thereto.

 

[***]

 

Permissible Change of Control ” means any Major Transaction involving the acquisition of a majority of the Total Voting Power of the Borrower where after giving effect to such Major Transaction: (i) the Borrower is a direct or indirect Subsidiary of a Person (such person, the “ Public Successor ”) whose common stock is listed for trading on a Principal Market, (ii) the Public Successor has a Debt to Adjusted EBITDA Ratio of less than [***], and (iii) the Collateral Agent continues to have a valid and perfected first priority security interest in the collateral granted to it pursuant to the Security Documents, subject to Permitted Liens.  For purposes of this definition, “ Debt to Adjusted EBITDA Ratio ” means the ratio of the Public

 

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

 

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Successor’s (x) Debt to (y) Adjusted EBITDA for the applicable Test Period where “Debt” means such Person’s and its consolidated Subsidiaries’ Indebtedness other than under clause (xi) thereof as of the end of the most recent Test Period, and where Debt and Adjusted EBITDA are both determined on a pro forma basis as if such Major Transaction, together with any Permitted Acquisition or Investment during or after the Test Period and before the date of determination had occurred at the beginning of the applicable Test Period, including any Indebtedness incurred in connection therewith.

 

Permitted Acquisition ” means (i) the Acquisition and (ii) any transaction or series of related transactions by which the Borrower or any of its Subsidiaries acquires all or substantially all of the assets of a Person or going business, division, or line of business or product or acquires Capital Stock of any Person having at least a majority of combined voting power of the then outstanding Capital Stock of such Person which meets the following conditions (A) [***], and (B) no Default or Event of Default shall have occurred and be continuing at the time of the consummation thereof or would occur immediately after giving effect thereto.

 

Permitted Liens ” has the meaning set forth in Section 6.3 .

 

Person ” means an individual, a corporation, a partnership, a limited liability company, an association, a trust or any other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.

 

Plan ” means, at any time, an employee pension benefit plan that is covered by Title IV of ERISA or subject to the minimum funding standards under Section 412 of the Code and is either (i) maintained by a member of the Controlled Group for employees of any member of the Controlled Group or (ii) maintained pursuant to a collective bargaining agreement or any other arrangement under which more than one employer makes contributions and to which a member of the Controlled Group is then making or accruing an obligation to make contributions or has within the preceding five plan years made contributions.

 

Prepayment Premium ” means, with respect to any prepayment of the principal amount of the Notes, an amount equal to (i) 5% of the principal amount of Notes to be prepaid, if such prepayment occurs on or prior to the second anniversary of the Purchase Date; (ii) 4% of the principal amount of the Notes to be prepaid, if such prepayment occurs after the second anniversary of the Purchase Date but on or prior to the third anniversary of the Purchase Date; (iii) 3% of the principal amount of the Notes to be prepaid, if such prepayment occurs after the third anniversary of the Purchase Date but on or prior to the fourth anniversary of the Purchase Date; (iv) 2% of the principal amount of the Notes to be prepaid, if such prepayment occurs after the fourth anniversary of the Purchase Date but on or prior to the fifth anniversary of the Purchase Date; (v) 1% of the principal amount of the Notes to be prepaid, if such prepayment occurs after the fifth anniversary of the Purchase Date but on or prior to the sixth anniversary of the Purchase Date; and (vi) zero, if such prepayment occurs after the sixth anniversary of the Purchase Date.

 

Principal Market ” means any of the New York Stock Exchange, the NYSE MKT, the NASDAQ Global Select Market, the NASDAQ Global Market or the NASDAQ Capital Market.

 

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

 

14



 

Purchase Date ” means the date upon which the Notes are purchased pursuant to this Agreement, which shall be the date upon which each of the conditions set forth in Section 3.2 shall have been satisfied or waived in accordance with the terms of this Agreement.

 

Purchaser ” means each Person signatory hereto as a “Purchaser” and their respective registered successors and assigns.

 

Qualified Capital Stock ” means any Capital Stock of a Person that does not include a cash dividend (other than dividends that are solely payable as and when declared by the board of directors of such Person) and are not mandatorily redeemable by such Person or any of its Subsidiaries or redeemable at the option of the holder of such Capital Stock, in each case prior to the 91st day following the Maturity Date (other than (i) redemptions solely for Qualified Capital Stock in such Person and cash in lieu of fractional shares of such Capital Stock and (ii) redemptions upon the occurrence of an “asset sale”, “fundamental change” or a “change in control” (or similar event, however denominated) so long as any such redemption requirement becomes operative only after repayment in full (or waiver thereof) of all the Obligations (other than contingent indemnification obligations)); provided , however , that Capital Stock in any Person that is issued to any employee or to any plan for the benefit of employees or by any such plan to such employees shall constitute Qualified Capital Stock notwithstanding any obligation of such Person or any Subsidiary to repurchase such Capital Stock in order to satisfy applicable statutory or regulatory obligations or as a result of such employee’s termination, death or disability.

 

Recipient ” means the Collateral Agent or any Purchaser, as applicable.

 

Register ” has the meaning set forth in Section 1.4(a) .

 

Related Parties ” means, with respect to any Person, such Person’s Affiliates and the partners, directors, officers, employees, agents, trustees, administrators, managers, advisors and representatives of such Person and of such Person’s Affiliates.

 

Regulatory Agency ” means a Governmental Authority with responsibility for the approval of the marketing and sale of pharmaceuticals or medical devices or other regulation of pharmaceuticals or medical devices.

 

Regulatory Approval ” means all approvals (including where applicable, pricing and reimbursement approval and schedule classifications), product and/or establishment licenses, registrations or authorizations of any Regulatory Agency necessary for the manufacture, use, storage, import, export, transport, offer for sale or sale of the Material Products by a Consolidated Entity (other than Depo DR) within the United States.

 

Required Purchasers ” means, prior to the Purchase Date, Purchasers obligated with respect to greater than the Applicable Percentage of the Commitments and, thereafter, Purchasers representing greater than the Applicable Percentage of the outstanding principal amount of the Notes.

 

Requirement of Law ” means, with respect to any Person, the charter, articles or certificate of organization or incorporation and bylaws or other organizational or governing

 

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

 

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documents of such Person, and any statute, law, treaty, rule, regulation, order, decree, writ, injunction or determination of any arbitrator or court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject or otherwise pertaining to any or all of the transactions contemplated by this Agreement and the other Credit Documents.

 

Restricted Purchaser ” means Deerfield and its Affiliates and any other Purchaser that notifies the Borrower in writing that it wishes to be deemed a Restricted Purchaser.

 

Restricted Transferee ” means any Person (i) who is a natural Person or (ii) [***].

 

Sanctioned Country ” means a country subject to a sanctions program identified on the list maintained by OFAC and available at http://www.treas.gov/offices/enforcement/ofac/programs/, or as otherwise published from time to time.

 

Sanctioned Person ” means (i) a Person named on the list of Specially Designated Nationals or Blocked Persons maintained by OFAC available at http://www.treas.gov/offices/enforcement/ofac/sdn/index.shtml, or as otherwise published from time to time, or (ii)(A) an agency of the government of a Sanctioned Country, (B) an organization controlled by a Sanctioned Country or (C) a Person resident in a Sanctioned Country, to the extent subject to a sanctions program administered by OFAC.

 

SEC ” means the Securities and Exchange Commission.

 

Securities Act ” means the U.S. Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

Security Agreement ” means the Pledge and Security Agreement, dated as of the date hereof, between each Credit Party and the Collateral Agent, substantially in the form attached as Exhibit F hereto.

 

Security Documents ” means the Security Agreement, the Landlord Agreement, the Deposit Account Control Agreements, and all other pledge or security agreements, mortgages, deeds of trust, assignments or other similar agreements or instruments executed and delivered by the Borrower or any of the Borrower’s Subsidiaries pursuant to the terms of this Agreement, in each case as amended, modified or supplemented from time to time.

 

Solvent ” means, with respect to any Person (determined on a consolidated basis) on any particular date, that such Person (i) does not have unreasonably small capital to carry on its business as now conducted and as presently proposed to be conducted, (ii) is able to pay its debts as they become absolute and matured, and (iii) has assets with a present fair saleable value greater than its total stated liabilities and identified contingent liabilities.  In computing the amount of identified contingent liabilities at any time, such liabilities shall be computed at the amount that, in light of all the facts and circumstances existing at such time, represents the amount that can reasonably be expected to become an actual or matured liability.

 

Subsidiary ” means, with respect to any Person, any corporation, partnership, limited liability company, association or other business entity of which such Person owns, directly or

 

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

 

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indirectly, more than 50% of the voting securities thereof.  Unless the context otherwise requires, “Subsidiary” refers to a direct or indirect Subsidiary of the Borrower.

 

Subsidiary Guarantor ” means any Subsidiary of the Borrower that is a guarantor of the Obligations under the Guaranty (or under another guaranty agreement in form and substance satisfactory to the Purchasers) and has granted to the Collateral Agent, on behalf of the Purchasers, a Lien upon and security interest in its personal property assets pursuant to the Security Agreement. For the avoidance of doubt, no Excluded Foreign Subsidiary shall be a Subsidiary Guarantor.

 

Taxes ” means all present or future taxes, levies, imposts, duties, deductions, withholdings (including backup withholding), assessments, fees or other charges imposed by any Governmental Authority, including any interest, additions to tax or penalties applicable thereto.

 

Termination Date ” means June 28, 2015.

 

Test Period ” means, at any date of determination, the period of four consecutive fiscal quarters of the Borrower (or other Person, as applicable) then last ended for which financial statements have been filed with the SEC.

 

Total Voting Power ” means, with respect to any Person, the total number of votes that may be cast in the election of directors or managers, as applicable, of such Person at any meeting of stockholders or members, as applicable, of such Person if all securities entitled to vote in the election of directors or managers, as applicable, of such Person (on a fully diluted basis, assuming the exercise, conversion or exchange of all rights, warrants, options and securities exercisable for, exchangeable for or convertible into, such voting securities) were present and voted at such meeting (other than votes that may be cast only upon the happening of a contingency).

 

UCC ” means the Uniform Commercial Code as the same may be in effect from time to time in the State of New York; provided that if, by reason of applicable law, the validity, priority or perfection of any security interest in any collateral granted under any Credit Agreement is governed by the Uniform Commercial Code as in effect in another jurisdiction, then, as to the validity, priority or perfection, as the case may be, of such security interest, “ UCC ” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction.

 

Upfront Payments ” means any upfront or similar payments made in connection with any drug or pharmaceutical product research and development or collaboration arrangements or the closing of any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product or medical device (and any related property or assets).

 

U.S. Person ” means any Person that is a “United States person” as defined in Section 7701(a)(30) of the Code.

 

U.S. Tax Compliance Certificate ” has the meaning specified in Section 2.11(c).

 

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

 

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Wholly Owned ” means, with respect to any Subsidiary of any Person, that 100% of the outstanding Capital Stock of such Subsidiary (other than directors’ qualifying shares) is owned, directly or indirectly, by such Person.

 

1.2                                Accounting Terms .  Except as specifically provided otherwise in this Agreement, all accounting terms used herein that are not specifically defined have the meanings customarily given them in accordance with GAAP as in effect from time to time, provided that if the Borrower notifies the Purchasers that the Borrower requests an amendment to any provision hereof to eliminate the effect of any change occurring after the date hereof in GAAP or in the application thereof on the operation of such provision, regardless of whether any such notice is given before or after such change in GAAP or in the application thereof, then such provision shall be interpreted on the basis of GAAP as in effect and applied immediately before such change shall have become effective until such notice shall have been withdrawn or such provision amended in accordance herewith; provided , further , that all terms of an accounting or financial nature (including, without limitation, the definitions of Capital Lease Obligations and Indebtedness) shall be construed without giving effect to (i) any changes to the current GAAP accounting model for leases of the type described in the FASB and IASB joint exposure draft published on August 17, 2010 entitled “Leases (Topic 840)” or otherwise arising out of the FASB project on lease accounting described in such exposure draft, (ii) any election under Accounting Standards Codification 825-10-25 (previously referred to as Statement of Financial Accounting Standards 159) (or any other Accounting Standards Codification or Financial Accounting Standard having a similar result or effect) to value any Indebtedness or other liabilities of the Borrower or any Subsidiary at “fair value,” as defined therein and (iii) any treatment of Indebtedness in respect of convertible debt instruments under Accounting Standards Codification 470-20 (or any other Accounting Standards Codification or Financial Accounting Standard having a similar result or effect) to value any such Indebtedness in a reduced or bifurcated manner as described therein, and such Indebtedness shall at all times be valued at the full stated principal amount thereof.

 

1.3                                Interpretation .  Whenever the context so requires, the neuter gender includes the masculine and feminine, the singular number includes the plural, and vice versa.  The words “include,” “includes” and “including” shall in any event be deemed to be followed by the phrase “without limitation.”  All references in this Agreement to “this Agreement”, “herein”, “hereunder”, “hereof” shall be deemed to refer to this Agreement in its entirety (including the exhibits (and their annexes) and schedules hereto) unless the context requires otherwise.  All references in this Agreement to Articles, Sections, Exhibits, Annexes and Schedules shall be construed to refer to Articles and Sections of, and Exhibits, Annexes and Schedules to, this Agreement unless the context requires otherwise.  Except as otherwise provided herein, any definition of or reference to any agreement, instrument or other document shall be construed as referring to such agreement, instrument or other document as from time to time amended, restated, supplemented or otherwise modified in accordance with any restrictions on such amendments, restatements, supplements or modifications set forth herein or in any other Credit Document.  Any reference to any law or regulation herein shall, unless otherwise specified, refer to such law or regulation as amended, modified or supplemented from time to time.

 

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

 

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1.4                                Register.

 

(a)                                  The Borrower shall establish and maintain at its address referred to in Section 9.5 (i) a record of ownership (the “ Register ”) in which the Borrower shall register by book entry the interests (including any rights to receive payment of principal and interest hereunder) of each Purchaser in each Note, and any assignment of any such interest and (ii) accounts in the Register in accordance with its usual practice in which it shall record (A) the names and addresses of the Purchasers (and any change thereto pursuant to this Agreement), (B) the amount of Commitments of, and principal amounts (and stated interest) owing to each Purchaser and (C) any other payment received by the Purchasers pursuant to the Credit Documents.

 

(b)                                  Notwithstanding anything to the contrary contained in this Agreement, (i) each Note is a registered obligation, (ii) the right, title and interest of the Purchasers and their assignees in and to the Notes or any portion thereof shall be transferable only upon notation of such transfer in the Register and (iii) no assignment thereof therein shall be effective until recorded therein.  This Section 1.4 and Sections 9.7 and 9.8 shall be construed so that each Note is at all times maintained in “registered form” within the meaning of Sections 163(f), 871(h)(2) and 881(c)(2) of the Code and Section 5f.103-1(c) of the United States Treasury Regulations.

 

(c)                                   The entries in the Register shall be conclusive absent manifest error, and the Borrower, the Collateral Agent and the Purchasers shall treat each Person whose name is recorded in the Register as a Purchaser (and as the owner of the amounts owing to it under the Notes as reflected in the Register) for all purposes of this Agreement.  Information contained in the Register with respect to any Purchaser shall be available for access by such Purchaser at any reasonable time and from time to time upon reasonable prior notice.

 

ARTICLE II

 

AMOUNTS AND TERMS OF THE NOTES

 

2.1                                Notes and Commitments; Notice of Purchase .

 

(a)                                  The Borrower agrees to issue, and each Purchaser severally agrees, subject to and on the terms and conditions set forth in this Agreement, to purchase, a Note from the Borrower on any Business Day on or after April 2, 2015 (or earlier if agreed to by all the Purchasers) but prior to the Termination Date, in a principal amount equal to such Purchaser’s Commitment.  The Commitments shall be automatically and permanently terminated (i) concurrently with the purchase of the Notes on the Purchase Date, and (ii) on the Termination Date.  To the extent repaid, the principal amount under Notes may not be re-borrowed.

 

(b)                                  At least three Business Days prior to the Borrower’s expected satisfaction, or waiver by the Required Purchasers of, the conditions to purchasing the Notes set forth in Section 3.2 , the Borrower shall deliver to the Purchasers a written notice (the “ Purchase Notice ”), which notice shall be irrevocable (but may be contingent upon the concurrent consummation of the Acquisition), shall be substantially in the form of Exhibit C hereto and shall specify (1) the account(s) to which the proceeds of the Notes are to be disbursed pursuant to Section 2.9 and (2) the requested Purchase Date.

 

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

 

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2.2                                Notes .  The Notes shall be payable to the applicable Purchaser in an amount equal to the principal amount of such Purchaser’s Commitment.  The terms of this Agreement shall be incorporated by reference into the Notes as if set forth therein and, in the event of any conflict between the terms of this Agreement and the Notes, the terms of this Agreement shall control.

 

2.3                                Interest .

 

(a)                                  The Borrower shall pay interest on each Note from the Purchase Date on the outstanding principal amount thereof at the per annum interest rate equal to Interest Rate as determined on the most recent Interest Rate Determination Date.  The Collateral Agent shall give notice to the Borrower and the Purchasers of the Interest Rate on each Interest Rate Determination Date.

 

(b)                                  Interest on the outstanding principal balance of each Note shall be due and payable (i) on each Interest Rate Determination Date, in arrears, until the entire principal amount of the Notes plus interest thereon is paid in full, and (ii) on each date when all or any amount of the unpaid principal balance of each such Note shall be due (whether at maturity, by acceleration, prepayment or otherwise), but only to the extent accrued and only with respect of the principal amount being paid.

 

(c)                                   Interest on the Notes and fees shall be computed on the basis of a 360-day year and the actual number of days elapsed.

 

(d)                                  If the Borrower shall default in the payment of any principal of or interest on any Note, by acceleration or otherwise (after expiration of all applicable grace periods), then, until such defaulted amount shall have been paid in full, all such overdue amounts shall bear interest (after as well as before judgment) at a rate per annum equal to the Interest Rate plus 10.00% per annum (the “ Default Rate ”).

 

(e)                                   Nothing contained in this Agreement or the Notes shall be deemed to establish or require the payment of interest to the Purchasers at a rate in excess of the maximum rate permitted by applicable law.  In the event that the rate of interest required to be paid under this Agreement or the Notes exceeds the maximum rate permitted by applicable law, the rate of interest required to be paid hereunder and under the Notes shall be automatically reduced to the maximum rate permitted by applicable law and any amounts collected in excess of the permissible amount shall be deemed a prepayment of principal of the Notes.

 

2.4                                Purchase Price and Fees .

 

(a)                                  The purchase price for the Notes shall be 97.75% of the principal amount thereof.  The Purchasers and the Borrower intend and agree that the Notes shall be treated as indebtedness for U.S. federal income tax purposes. The Notes shall be issued with “original issue discount” (“ OID ”).  The “issue price” for the Note held by each Purchaser shall equal 97.75% of the principal amount of the Notes.  Each party hereto agrees to use the foregoing issue price for all applicable tax purposes with respect to this transaction, and to file all required tax returns consistently with the foregoing, as applicable.  The inclusion of this Section 2.4(a)  is not an admission by any Purchaser that it is subject to United States taxation.  The Purchasers may

 

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

 

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obtain the issue price, the amount of OID, issue date and yield to maturity with respect to their Notes by submitting a written request to the Borrower.

 

(b)                                  As additional consideration for the Commitments, in the event that during the twelve-month period commencing on the date of this Agreement the Borrower or any of its Subsidiaries or Affiliates consummates the Acquisition, in accordance with the terms of the Acquisition Agreement or otherwise, without selling the Notes to the Purchasers pursuant to this Agreement (other than as a result of a failure or refusal by the Purchasers to purchase the Notes), the Borrower agrees to pay the Purchasers a fee in an amount equal to [***], which fee will be fully earned and will be due and payable in full in cash on the closing date of the Acquisition.

 

2.5                                Scheduled Principal Payments; Maturity of Notes .  The principal of the Notes shall be repaid by the Borrower on the dates and in the amounts set forth below.  If not sooner paid, the outstanding principal amount of the Notes and all accrued (and theretofore unpaid) interest shall be due and payable on the Maturity Date.

 

Date

 

Payment Amount

 

Third Anniversary of the Purchase Date   

 

$

57,500,000

 

Fourth Anniversary of the Purchase Date 

 

$

115,000,000

 

Fifth Anniversary of the Purchase Date     

 

$

115,000,000

 

Sixth Anniversary of the Purchase Date     

 

$

143,750,000

 

 

2.6                                Optional Prepayments .

 

(a)                                  At any time after the first anniversary of the Purchase Date and on or prior to the second anniversary of the Purchase Date, the Borrower shall have the right to prepay up to $100,000,000 principal amount of the Notes, together with accrued (and theretofore) unpaid interest on the principal amount prepaid plus the Prepayment Premium.

 

(b)                                  At any time prior to the second anniversary of the Purchase Date, the Borrower shall have the right to prepay the Notes in whole in connection with, or pursuant to, a Major Transaction, together with accrued (and theretofore) unpaid interest on the principal amount prepaid plus (i) the applicable Prepayment Premium, and (ii) an additional amount equal to the amount of interest that would have accrued from, and including, the date of prepayment to, but excluding, the second anniversary of the Purchase Date on the principal amount of the Notes outstanding immediately prior to such prepayment in excess of $100,000,000, using an interest rate for such purposes equal to the Interest Rate as of the most recent Interest Rate Determination Date prior to the date such prepayment is required to be made.

 

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

 

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(c)                                   At any time after the second anniversary date and from time to time thereafter, the Borrower shall have the right to prepay the Notes, in whole or in part, together with accrued (and theretofore) unpaid interest on the principal amount prepaid plus, if applicable, the Prepayment Premium.

 

(d)                                  Any prepayment in part pursuant to this Section 2.6 must be made in a minimum principal amount of [***].  If the Borrower wishes to make such a prepayment, it shall give the Purchasers notice in writing to that effect not later than the third Business Day prior to the date of the prepayment, specifying the date on which the prepayment is to be made and the principal amount to be prepaid.  Such notice shall constitute the Borrower’s irrevocable commitment to prepay that amount on that date, together with accrued (and theretofore) unpaid interest on the principal amount prepaid to but excluding the prepayment date plus, if applicable, the Prepayment Premium and any additional amounts owed under Section 2.6(b)(ii) ; provided , that any such notice with respect to a prepayment under Section 2.6(b)  or Section 2.6(c)  may be contingent upon the consummation of a financing, Major Transaction or other specified event.

 

2.7                                Mandatory Prepayments .

 

(a)                                  Convertible Notes .  If the principal amount outstanding on the Convertible Notes as of March 31, 2021 is greater than $100,000,000, the Borrower shall prepay in full the outstanding principal amount of the Notes and all accrued (and theretofore unpaid) interest thereon.

 

(b)                                  Asset Disposition Proceeds .  Promptly upon (and in any event not later than one Business Day after) receipt of Asset Disposition Proceeds in excess of [***] (as such receipt may occur from time to time after the Purchase Date), the Borrower shall prepay the outstanding principal amount of the Notes in an amount equal to the amount of such excess (giving effect to any previous principal prepayments under this Section 2.7(b) ), together with accrued (and theretofore) unpaid interest on the principal amount prepaid.  Each prepayment pursuant to this Section 2.7(b)  shall be applied to the remaining amortization payments in the inverse order of maturity.

 

(c)                                   Major Transaction .  If the Borrower gives (or is required to give) the Purchasers notice of a Major Transaction pursuant to Section 5.2(b)  that is not a Permissible Change of Control, the Required Purchasers may, by written notice to the Borrower, require the Borrower to prepay the Notes in whole.  Such prepayment notice shall be delivered to the Borrower at least 10 Business Days prior to the effective date of such Major Transaction or, in the event that notice of such Major Transaction is given by the Borrower less than 20 Business Days prior to the effective date of such Major Transaction, at least 7 calendar days prior to such effective date and shall specify the date of prepayment, which may not be earlier the date of consummation of such Major Transaction.  The amount payable by the Borrower in connection with such prepayment shall be equal to (i) the aggregate outstanding principal amount of the Notes, together with accrued (and theretofore) unpaid interest plus (ii) if applicable, the Prepayment Premium, and (iii) if such prepayment is prior to the second anniversary of the Purchase Date, the amount of interest that would have accrued from, and including, the date of prepayment to, but excluding, the second anniversary of the Purchase Date on the principal amount of the Notes outstanding immediately prior to such prepayment in excess of $100,000,000, using an interest rate for such

 

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

 

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purposes equal to the Interest Rate as of the most recent Interest Rate Determination Date prior to the date such prepayment is required to be made.  The Required Purchaser will also deliver any prepayment notice given to the Borrower pursuant to this section to the other Purchasers on or about the same time such notice is provided to the Borrower; provided , that the delivery of or failure to deliver such prepayment notice to the other Purchasers shall not in any way effect the obligations of the Borrower, or the rights of the Required Purchasers, under this section.

 

2.8                                General Provisions as to Payments .  Any payments and other amounts owing under this Agreement shall be made at the applicable Purchaser’s address as set forth in Section 9.5 , prior to 11:00 a.m., New York City time, on the date when due, unless otherwise designated by the Purchasers in writing.  Each payment hereunder shall be applied (i)  first , to the reasonable documented and out-of-pocket costs and expenses of the Purchasers (allocated as reasonably determined by the Collateral Agent and, without prejudice to the Borrower’s obligations pursuant to Section 9.1 , invoiced to the Borrower at least one Business Day prior to the date of the applicable payment), (ii)  second , to accrued interest, (iii)  third , to the Prepayment Premium, if any, (iv)  fourth , to principal, which will be repaid first to any principal due and owing at the time of such payment, then in inverse chronological order of maturity, and (v)  fifth , to any remaining amounts then due and payable under the Credit Documents.

 

2.9                                Disbursement of Note Proceeds .  The Borrower hereby authorizes and directs the Purchasers to disburse, for and on behalf of the Borrower and for the Borrower’s account, the proceeds of the Notes made by the Purchasers pursuant to this Agreement (i) to such Person or Persons as the Borrower shall direct in writing and (ii) to pay the Purchasers any fees pursuant to Section 2.4 and any reasonable and documented out-of-pocket expenses payable pursuant to Section 9.1 ; provided that, without prejudice to the Borrower’s obligations pursuant to Section 9.1 , such costs and expenses shall have been invoiced to the Borrower at least one Business Day prior to the Purchase Date.

 

2.10                         Use of Proceeds .  The proceeds of the Notes shall be used by the Borrower solely (i) to pay fees and expenses in connection with the transactions contemplated by this Agreement, (ii) to finance a portion of the consideration to be paid in connection with the Acquisition pursuant to the terms of the Acquisition Agreement, and (iii) to the extent any proceeds remain after the application thereof as contemplated by clauses (i) and (ii) above, for general corporate purposes.

 

2.11                         Taxes .

 

(a)                                  All payments of principal, interest, premium and fees and all other amounts to be paid by the Credit Parties to any Purchaser pursuant to the Credit Documents shall be paid without deduction for, and free from, any Taxes, except as required by applicable law.  If any applicable law requires the deduction or withholding of any Tax from any such payment by a Credit Party, then the applicable Credit Party shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant Governmental Authority in accordance with applicable law and, if such Tax is an Indemnified Tax, then the sum payable by the applicable Credit Party shall be increased as necessary so that after such deduction or withholding has been made (including such deductions and withholdings applicable to additional sums payable under this Section) the applicable Recipient receives an

 

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

 

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amount equal to the sum it would have received had no such deduction or withholding been made, and within 30 days after the applicable Credit Party pays the Tax, such Credit Party shall deliver to the applicable Recipient an original or certified copy of a receipt evidencing such payment, a copy of the tax return reporting such payment or other evidence of payment reasonably satisfactory to such Recipient.

 

(b)                                  Payment of Other Taxes by the Borrower .  The Credit Parties shall timely pay to the relevant Governmental Authority in accordance with applicable law, or at the option of the Collateral Agent timely reimburse it for the payment of, any Other Taxes.

 

(c)                                   Status of Purchasers .

 

(i)                                      Any Purchaser that is entitled to an exemption from or reduction of withholding Tax with respect to payments made under any Credit Document shall deliver to the Borrower, at the time or times reasonably requested by the Borrower, such properly completed and executed documentation reasonably requested by the Borrower as will permit such payments to be made without withholding or at a reduced rate of withholding.  In addition, any Purchaser, if reasonably requested by the Borrower, shall deliver such other documentation prescribed by applicable law or reasonably requested by the Borrower as will enable the Borrower to determine whether or not such Purchaser is subject to backup withholding or information reporting requirements.

 

(ii)                                   Without limiting the generality of the foregoing:

 

any Purchaser that is a U.S. Person shall deliver to the Borrower on or prior to the date on which such Purchaser becomes a Purchaser under this Agreement (and from time to time thereafter upon the reasonable request of the Borrower), two executed copies of IRS Form W-9 certifying that such Purchaser is exempt from U.S. federal backup withholding tax;

 

any Foreign Purchaser shall, to the extent it is legally entitled to do so, deliver to the Borrower (in such number of copies as shall be reasonably requested by the recipient) on or prior to the date on which such Foreign Purchaser becomes a Purchaser under this Agreement (and from time to time thereafter upon the reasonable request of the Borrower), whichever of the following is applicable:

 

in the case of a Foreign Purchaser claiming the benefits of an income tax treaty to which the United States is a party, executed copies of IRS Form W-8BEN or W-8BEN-E establishing an exemption from, or reduction of, U.S. federal withholding Tax;

 

executed copies of IRS Form W-8ECI;

 

in the case of a Foreign Purchaser claiming the benefits of the exemption for portfolio interest under Section 881(c) of the Code, (x) a certificate substantially in the form of Exhibit D-1 to the effect that such Foreign Purchaser is not a “bank” within the meaning of Section

 

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

 

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881(c)(3)(A) of the Code, a “10 percent shareholder” of the Borrower within the meaning of Section 881(c)(3)(B) of the Code, or a “controlled foreign corporation” described in Section 881(c)(3)(C) of the Code (a “U.S. Tax Compliance Certificate”) and (y) executed copies of IRS Form W-8BEN or W-8BEN-E; or

 

to the extent a Foreign Purchaser is not the beneficial owner, executed copies of IRS Form W-8IMY, accompanied by IRS Form W-8ECI, IRS Form W-8BEN, IRS Form W-8BEN-E, IRS Form W-9, and/or other certification documents from each beneficial owner, as applicable; provided that if the Foreign Lender is a partnership and one or more direct or indirect partners of such Foreign Lender are claiming the portfolio interest exemption, such Foreign Lender shall provide a U.S. Tax Compliance Certificate substantially in the form of Exhibit D-2 ;

 

any Foreign Purchaser shall, to the extent it is legally entitled to do so, deliver to the Borrower (in such number of copies as shall be reasonably requested by the recipient) on or prior to the date on which such Foreign Purchaser becomes a Purchaser under this Agreement (and from time to time thereafter upon the reasonable request of the Borrower), executed copies of any other form prescribed by applicable law as a basis for claiming exemption from or a reduction in U.S. federal withholding Tax, duly completed, together with such supplementary documentation as may be prescribed by applicable law to permit the Borrower to determine the withholding or deduction required to be made; and

 

if a payment made to a Purchaser under any Credit Document would be subject to U.S. federal withholding Tax imposed by FATCA if such Purchaser were to fail to comply with the applicable reporting requirements of FATCA (including those contained in Section 1471(b) or 1472(b) of the Code, as applicable), such Purchaser shall deliver to the Borrower at the time or times prescribed by law and at such time or times reasonably requested by the Borrower such documentation prescribed by applicable law (including as prescribed by Section 1471(b)(3)(C)(i) of the Code) and such additional documentation reasonably requested by the Borrower as may be necessary for the Borrower to comply with its obligations under FATCA and to determine that such Purchaser has complied with such Purchaser’s obligations under FATCA or to determine the amount to deduct and withhold from such payment.  Solely for purposes of this clause (D), “FATCA” shall include any amendments made to FATCA after the date of this Agreement.

 

(iii)                                Each Purchaser agrees that if any form or certification it previously delivered becomes inaccurate in any respect, it shall update such form or certification or promptly notify the Borrower in writing of its legal inability to do so.

 

(d)                                  Treatment of Certain Refunds .  If any Purchaser determines, in its sole discretion exercised in good faith, that it has received a refund of any Taxes as to which it has been indemnified pursuant to this Section 2.11 (including by the payment of additional amounts

 

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

 

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pursuant to this Section 2.11 ), it shall pay to the applicable Credit Party an amount equal to such refund (but only to the extent of indemnity payments made under this Section with respect to the Taxes giving rise to such refund), net of all out-of-pocket expenses (including Taxes) of such Purchaser and without interest (other than any interest paid by the relevant Governmental Authority with respect to such refund).  Such Credit Party, upon the request of such Purchaser, shall repay to such Purchaser the amount paid over pursuant to this paragraph (h) (plus any penalties, interest or other charges imposed by the relevant Governmental Authority) in the event that such Purchaser is required to repay such refund to such Governmental Authority.  Notwithstanding anything to the contrary in this Section 2.11(d) , in no event will a Purchaser be required to pay any amount to a Credit Party pursuant to this Section 2.11(d)  the payment of which would place such Purchaser in a less favorable net after-Tax position than such Purchaser would have been in if the Tax subject to indemnification and giving rise to such refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts with respect to such Tax had never been paid.  This paragraph shall not be construed to require any Purchaser to make available its Tax returns (or any other information relating to its Taxes that it deems confidential) to any Credit Party or any other Person.

 

(e)                                   The Credit Parties shall reimburse and indemnify, within 30 days after receipt of demand therefor, each Purchaser for all Indemnified Taxes (including any Indemnified Taxes imposed by any jurisdiction on amounts payable under this Section 2.11(e) ) paid or payable by such Purchaser and any Costs arising therefrom or with respect thereto, whether or not such Indemnified Taxes were correctly or legally asserted; provided , that the Credit Parties shall not be required to compensate any Purchaser pursuant to this Section 2.11(e)  for any Indemnified Taxes incurred more than 180 days prior to the date that such Purchaser notifies the Borrower in writing of the increased costs and of Purchaser’s intention to claim compensation thereof; provided further , that if circumstances giving rise to such Indemnified Taxes is retroactive, then the 180-day period referred to above shall be extended to include the period of retroactive effect thereof.  A certificate of a Purchaser claiming any compensation under this clause (e), setting forth the amounts to be paid thereunder and delivered to the Credit Parties shall be conclusive, binding and final for all purposes, absent manifest error.

 

2.12                         Other Additional Costs . In the event that any applicable Change in Law:

 

(a)                                  imposes, modifies or holds applicable any reserve, capital requirement, special deposit, compulsory loan or similar requirements against assets held by, or deposits or other liabilities in or for the account of, advances or loans by, or other credit extended by, or any other acquisition of funds by, any Purchaser; or

 

(b)                                  imposes on any Purchaser any other condition (other than Taxes); and the result of any of the foregoing is to increase the cost to such Purchaser (as determined by such Purchaser in good faith using calculation methods customary in the industry) of making, renewing or maintaining any extension of credit hereunder or to reduce any amount receivable in respect thereof or to reduce the rate of return on the capital of such Purchaser or any Person controlling such Purchaser, then, in any such case, Borrower shall promptly pay to such Purchaser, upon its receipt of the certificate described below, any additional amounts necessary to compensate such Purchaser for such additional cost or reduced amounts receivable or rate of return as reasonably determined by such Purchaser with respect to this Agreement or the Notes

 

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

 

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purchased hereunder.  If a Purchaser becomes entitled to claim any additional amounts pursuant to this Section 2.12 , it shall promptly notify Borrower of the event by reason of which it has become so entitled, and a certificate as to any additional amounts payable pursuant to the foregoing sentence containing the calculation thereof in reasonable detail submitted by such Purchaser to Borrower shall be conclusive in the absence of manifest error.  Failure or delay on the part of a Purchaser to demand compensation for any increased costs or reduction in amounts received or receivable or reduction in return on capital under this Section 2.12 shall not constitute a waiver of a Purchaser’s right to demand such compensation; provided that Borrower shall not be under any obligation to compensate any Purchaser under this Section 2.12 with respect to increased costs or reductions with respect to any period prior to the date that is 180 days prior to the date of the delivery of the notice required pursuant to the foregoing provisions of this paragraph; provided further that the foregoing limitation shall not apply to any increased costs or reductions arising out of the retroactive application of any Change in Law within such 180-day period.

 

2.13                         Pro Rata Treatment .

 

(a)                                  The purchase of Notes on the Purchase Date shall be made by the Purchasers pro rata on the basis of their respective Commitments.  All payments on account of principal of or interest on any Notes, fees or any other Obligations owing to or for the account of any one or more Purchasers shall be apportioned ratably among such Purchasers in proportion to the amounts of such principal, interest, fees or other Obligations owed to them respectively.

 

(b)                                  If any Purchaser shall, by exercising any right of setoff (including in accordance with Section 7.2(c) ) or counterclaim or otherwise, obtain payment in respect of any principal of or interest on any of its Notes or other Obligations hereunder resulting in such Purchaser’s receiving payment of a proportion of the aggregate amount of its Notes and accrued interest thereon or other such Obligations greater than its pro rata share thereof as provided herein, then the Purchaser receiving such greater proportion shall (i) notify the other Purchasers of such fact and (ii) purchase (for cash at face value) participations in the Notes and such other Obligations of the other Purchasers, or make such other adjustments as shall be equitable, so that the benefit of all such payments shall be shared by the Purchasers ratably in accordance with the aggregate amount of principal of and accrued interest on their respective Notes and other amounts owing them; provided that (A) if any such participations are purchased and all or any portion of the payment giving rise thereto is recovered, then such participations shall be rescinded and the purchase price restored to the extent of such recovery, without interest, and (B) the provisions of this Section 2.13(b)  shall not be construed to apply to (x) any payment made by the Borrower pursuant to and in accordance with the express terms of this Agreement or (y) any payment obtained by a Purchaser as consideration for the assignment of or sale of a participation in any of its Notes to any assignee or participant, other than to the Borrower or any Subsidiary thereof (as to which the provisions of this Section 2.13(b)  shall apply).  The Borrower consents to the foregoing and agrees, to the extent it may effectively do so under applicable law, that any Purchaser acquiring a participation pursuant to the foregoing arrangements may exercise against the Borrower rights of setoff and counterclaim with respect to such participation as fully as if such Purchaser were a direct creditor of the Borrower in the amount of such participation.  If under any applicable bankruptcy, insolvency or similar law, any Purchaser receives a secured claim in lieu of a setoff to which this Section 2.13(b)  applies, then such Purchaser shall, to the

 

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

 

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extent practicable, exercise its rights in respect of such secured claim in a manner consistent with the rights of the Purchasers entitled under this Section 2.13(b)  to share in the benefits of any recovery on such secured claim.

 

2.14                         Mitigation Obligations .  If any Purchaser requests compensation under Section 2.12 , or requires the Borrower to pay any Indemnified Taxes or additional amounts to any Purchaser or any Governmental Authority for the account of any Purchaser pursuant to Section 2.11 , then such Purchaser shall (at the request of the Borrower) use reasonable efforts to designate a different lending office or an Affiliate for funding or booking its Notes hereunder or to assign its rights and obligations hereunder to another of its offices, branches or affiliates, if, in the judgment of such Purchaser, such designation or assignment (i) would eliminate or reduce amounts payable pursuant to Sections 2.11 or 2.12 , as the case may be, in the future, and (ii) would not subject such Purchaser to any unreimbursed cost or expense and would not otherwise be disadvantageous to such Purchaser.  The Borrower hereby agrees to pay all reasonable costs and expenses incurred by any Purchaser in connection with any such designation or assignment.

 

ARTICLE III

 

CONDITIONS TO EFFECTIVENESS AND PURCHASE OF NOTES

 

3.1                                Conditions to Effectiveness .  This Agreement shall be effective upon satisfaction of the following conditions precedent:

 

(a)                                  Agreement .  The Purchasers shall have received from each of the parties hereto, a duly executed counterpart of this Agreement, dated as of the date hereof, signed by such party.

 

(b)                                  Representations and Warranties .  Each of the representations and warranties made by the Credit Parties in this shall be true and correct on and as of the date hereof.

 

(c)                                   No Default . No Default shall have occurred and be continuing on and as of the date hereof.

 

3.2                                Conditions to Purchase of the Notes .  The obligation of each Purchaser to purchase any Notes hereunder is subject to the satisfaction of the following conditions precedent:

 

(a)                                  Credit Documents .  The Purchasers shall have received the following, each dated as of the Purchase Date (unless otherwise specified) and in such number of copies as the Purchasers shall have requested:

 

(i)                                      a duly executed Note for the account of each Purchaser;

 

(ii)                                   the Guaranty, duly completed and executed by each Subsidiary of the Borrower other than Depo DR, in form and substance satisfactory to the Purchasers;

 

(iii)                                the Security Agreement, duly completed and executed by each Credit Party, in form and substance satisfactory to the Purchasers;

 

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

 

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(iv)                               duly completed and executed grants of security interest in form required by or acceptable to the U.S. Copyright Office or the U.S. Patent and Trademark Office in respect of registered intellectual property included in the collateral granted under the Security Agreement; and

 

(v)                                  an opinion of counsel to the Credit Parties dated as of the Purchase Date and addressed to the Purchasers, in the form agreed on the date hereof with the Required Purchasers.

 

(b)                                  Secretary’s Certificate .  The Purchasers shall have received a certificate of the secretary or an assistant secretary of each Credit Party, dated as of the Purchase Date and in form and substance reasonably satisfactory to the Purchasers, certifying (i) that attached thereto is a true and complete copy of the articles or certificate of incorporation, certificate of formation or other organizational document and all amendments thereto of such party, certified as of a recent date by the Secretary of State (or comparable Governmental Authority) of its jurisdiction of organization, and that the same has not been amended since the date of such certification, (ii) that attached thereto is a true and complete copy of the bylaws, operating agreement or similar governing document of such party, as then in effect and as in effect at all times from the date on which the resolutions referred to in clause (iii) below were adopted to and including the date of such certificate, (iii) that attached thereto is a true and complete copy of resolutions adopted by the board of directors (or similar governing body) of such party, authorizing the execution, delivery and performance of this Agreement and the other Credit Documents to which it is a party, and (iv) as to the incumbency and genuineness of the signature of each officer of such party executing this Agreement or any of such other Credit Documents, and attaching all such copies of the documents described above.

 

(c)                                   Notice of Purchase .  The Purchasers shall have received a Purchase Notice in accordance with Section 2.1(b) .

 

(d)                                  Representations and Warranties .  Each of the representations and warranties made by the Credit Parties pursuant to Sections 4.1 , 4. 2 , 4. 3 , 4. 4 , 4. 5 , 4.6, 4.7, 4.20, 4.21 and 4.22 of this Agreement shall be true and correct on and as of the Purchase Date with the same effect as if made on and as of such date (except to the extent any such representation or warranty relates to a specific date, in which case such representation or warranty shall be true and correct as of such date.

 

(e)                                   No Default . No Default shall have occurred and be continuing on the Purchase Date or after giving effect to the purchase of Notes to be made on such date.

 

(f)                                    Acquisition .  Substantially concurrently with the purchase of Notes hereunder, the Acquisition shall have been consummated in accordance with the terms of the Acquisition Agreement and all other applicable documentation and in compliance with all applicable law and regulatory approvals, without any amendment or waiver of any material condition or other provision thereof except as approved by the Collateral Agent.

 

(g)                                   Officer’s Certificate .  The Purchasers shall have received a certificate, signed by an authorized officer of the Borrower, dated as of the Purchase Date and in form and substance

 

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

 

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satisfactory to the Purchasers, that all the conditions set forth in this Section 3.2 shall have been satisfied as required hereunder.

 

(h)                                  Good Standings .  The Purchasers shall have received a certificate as of a recent date of the good standing of each Credit Party as of the Purchase Date, under the laws of its jurisdiction of organization, from the Secretary of State (or comparable Governmental Authority) of such jurisdiction.

 

(i)                                      Lien Searches .  The Purchasers shall have received certified reports from an independent search service satisfactory to it listing any judgment or tax lien filing or UCC financing statement that, in each case, names any Credit Party as debtor in any of the jurisdictions listed beneath its name on Annex A to the Security Agreement, and the results thereof shall be reasonably satisfactory to the Purchasers.

 

(j)                                     Recording and Filing .  The Purchasers shall have received evidence that UCC financing statements naming the Credit Parties as debtors and the Collateral Agent as secured party and describing the collateral encumbered by the Security Documents have been duly filed in each jurisdiction necessary to perfect the Liens created by the Security Documents.

 

(k)                                  Stock Certificates .  The Collateral Agent shall have received certificates evidencing the Capital Stock being pledged under the Security Agreement as of the Purchase Date and undated assignments separate from certificate for any such certificate, duly executed in blank.

 

(l)                                      Fees; Expenses .  The Borrower shall have paid all reasonable documented and out-of-pocket expenses required hereunder or under any other Credit Document to be paid on or prior to the Purchase Date (including reasonable fees and expenses of counsel) in connection with this Agreement and the other Credit Documents.

 

3.3                                Acquisition Subsidiary .  [***]

 

ARTICLE IV

 

REPRESENTATIONS AND WARRANTIES

 

The Borrower represents and warrants to the Collateral Agent and the Purchasers as follows:

 

4.1                                Corporate Organization and Power .  Each Credit Party (i) is a corporation or a limited liability company duly organized or formed, validly existing and in good standing under the laws of the jurisdiction of its incorporation or formation, as the case may be; (ii) is duly qualified or licensed to do business and is in good standing in every other jurisdiction where the nature of its business or its properties makes such qualification or licensing necessary (except where the failure to be so qualified or licensed would not reasonably be expected to have a Material Adverse Effect); (iii) has full corporate or limited liability company power and authority to execute, deliver and perform the Credit Documents to which it is or will be a party, to own and hold its property and to engage in its business as presently conducted; (iv) has all material Regulatory Approvals necessary to sell the Material Products within the United States;

 

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

 

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and (v) has all other governmental licenses, permits, franchises, certificates, inspections, authorizations, consents and approvals required to carry on its business as it is now being conducted, except as would not reasonably be expected to have a Material Adverse Effect.

 

4.2                                Corporate Authority; No Conflict with Other Instruments or Law .  The execution, delivery and performance of this Agreement and the other Credit Documents and the consummation of the transactions contemplated hereby and thereby (i) are within the corporate or limited liability company power and authority of each Credit Party; (ii) have been duly authorized by all necessary corporate or limited liability company action on the part of each Credit Party; (iii) do not and will not conflict with, contravene or violate any provision of, or result in a breach of or default under, or require the waiver (not already obtained) of any provision of or the consent (not already given) of any Person under the terms of any Credit Party’s articles or certificate of incorporation or formation, its bylaws or operating agreement, or other applicable formation or organizational documents, or any Material Contract; (iv) will not violate, conflict with, give rise to any liability under, or constitute a default under any Requirement of Law; and (v) will not result in the creation, imposition, or acceleration of any indebtedness or tax or any Lien that is not a Permitted Lien of any nature upon, or with respect to, any Credit Party or any properties thereof.

 

4.3                                Due Execution and Delivery .  Each Credit Document to which any Credit Party is a party has been duly executed and delivered to the Purchasers by an officer of such Credit Party who has been duly authorized to perform such acts.

 

4.4                                Enforceability .  Each Credit Document to which any Credit Party is a party constitutes the valid and binding obligation of such Credit Party, enforceable against such Credit Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws, statutes or rules of general application affecting the enforcement of creditor’s rights or general principles of equity.

 

4.5                                Governmental Approval .  The execution, delivery and performance of each Credit Document to which any Credit Party is a party and the transactions contemplated thereby do not require any authorization, exemption, consent or approval of, notice to, or declaration or filing with, any Governmental Authority other than those obtained on or before the date hereof and filings required in connection with the perfection of any liens granted pursuant to the Credit Documents.

 

4.6                                Margin Stock .  No Consolidated Entity is engaged principally or as one of its important activities in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulation U or X of the Board of Governors of the Federal Reserve System).  The execution, delivery and performance of this Agreement and the use of the proceeds of the Notes or any extension of credit hereunder, do not and will not constitute a violation of such Regulations.

 

4.7                                Investment Company .  No Credit Party is an “investment company” or a company “controlled” by an “investment company,” within the meaning of the Investment Company Act of 1940.

 

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

 

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4.8                                Litigation .  Except as disclosed in the most recent Form 10-K filed by the Borrower, there are no suits or proceedings pending or threatened against or affecting any Consolidated Entity and no proceedings before any Governmental Authority are pending or threatened against any such Person of a type that would need to be reported in a Form 8-K, 10-K or 10-Q filed with the SEC pursuant to the Securities Act or that would reasonably be expected to have a Material Adverse Effect.

 

4.9                                Financial Statements .

 

(a)                                  The Borrower has filed with the SEC the audited consolidated balance sheets of the Borrower as of December 31, 2014 and 2013, in each case with the related statements of income, cash flows and stockholders’ equity for the fiscal years then ended, together with the opinion of an independent certified public accounting firm thereon.  Such financial statements fairly present, in all material respects, the financial position, assets and liabilities of the Consolidated Entities for the respective periods then ended in accordance with GAAP.

 

(b)                                  Each Credit Party is Solvent.

 

4.10                         No Material Adverse Effect .  Since December 31, 2014, there has been no Material Adverse Effect and there exists no event, condition or state of facts that would reasonably be expected to result in a Material Adverse Effect.

 

4.11                         Capitalization; Subsidiaries Schedule 4.11 sets forth (i) all of the Subsidiaries of the Borrower and (ii) as to each Subsidiary (x) the number (and, if applicable, the effect if exercised) of shares, units or other interests of each class of Capital Stock outstanding and (y) the direct holders of all such Capital Stock and the number of shares, units or other interests held by each.  All outstanding shares of Capital Stock of the Borrower and each of its Subsidiaries are duly and validly issued, fully paid and nonassessable.  Except for the shares, units and other interests of Capital Stock expressly indicated on Schedule 4.11 , there are no shares, units or other interests of Capital Stock of any Subsidiary outstanding or reserved for any purpose.  No Consolidated Entity is a party to any partnership, joint venture or similar agreement.

 

4.12                         Laws and Taxes .

 

(a)                                  Each Consolidated Entity is in compliance with all laws, regulations, rulings, orders, injunctions, decrees, conditions or other requirements applicable to or imposed upon such Credit Party by any law or by any Governmental Authority, except where the failure to be in compliance would not reasonably be expected to result in a Material Adverse Effect.  Each Consolidated Entity is in compliance in all material respects with all applicable material Regulatory Approvals.

 

(b)                                  Each Consolidated Entity has filed all required federal income tax returns and reports that are now required to be filed by it, and all other tax returns (including state, local and foreign tax returns) that are required to be filed by it in connection with any material tax, duty or charge levied, assessed or imposed upon such Person or its assets, including any material unemployment, social security, and real estate taxes.  Each Consolidated Entity has paid all federal income Taxes and all other material Taxes (including material state, local and foreign

 

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

 

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Taxes) now due and payable other than any Tax that is being diligently contested in good faith for which adequate reserves have been established in accordance with GAAP.  There is no ongoing audit or examination or, to the knowledge of any Credit Party, other investigation by any Governmental Authority of any material tax liability of any Consolidated Entity, and there is no material unresolved claim by any Governmental Authority concerning the tax liability of any Consolidated Entity for any period for which tax returns have been or were required to have been filed, other than claims for which adequate reserves have been established in accordance with GAAP.  No Consolidated Entity has waived or extended or has been requested to waive or extend the statute of limitations relating to the payment of any taxes.  Proper and accurate amounts have been withheld by each Consolidated Entity from their respective employees for all periods in all material respects with the Tax, social security and unemployment withholding provisions of applicable laws and such withholdings have been timely paid to the respective Governmental Authorities.  No Consolidated Entity has participated in a “listed transaction” within the meaning of Treasury Regulation Section 1.6011-4(b) or has been a member of an affiliated, combined or unitary group other than the group of which a Consolidated Entity is the common parent.

 

4.13                         Environmental Compliance .  The Borrower has not generated, used, released, treated, disposed of or stored Hazardous Materials, or otherwise located, in, on or under any property owned, leased or operated by any Consolidated Entity or any portion thereof except in material compliance with all applicable laws, and, to the Borrower’s knowledge, no part of the property owned, leased or operated by any Consolidated Entity (now or in the past), including the soil and groundwater located thereon and thereunder, has been contaminated by any Hazardous Material.  To the knowledge of Borrower, no property owned, leased or operated by any Consolidated Entity has been the subject of an environmental audit or assessment, or remedial action.

 

4.14                         Ownership of Properties .  No Consolidated Entity owns any real property.  Each Consolidated Entity (i) holds interests as lessee under valid leases in full force and effect with respect to all material leased real and personal property used in connection with its business and (ii) has good title to all of its other material properties and assets reflected in the financial statements referred to in Section 4.9 (except as sold or otherwise disposed of since the date thereof in the ordinary course of business), in each case free and clear of all Liens other than Permitted Liens.  Schedule 4.14 lists, as of the date hereof, all real property used by any Credit Party, indicating in each case the identity of the owner, the address of the property, the nature of use of the premises and the nature of such interest (including whether such interest is a license, leasehold or fee ownership interest).

 

4.15                         Intellectual Property .  Each Consolidated Entity owns, or has the right to use, all Intellectual Property reasonably necessary for it to conduct its business as currently conducted.  Except as disclosed in the most recent Form 10-K filed by the Borrower, no claim has been asserted or is pending by any Person challenging or questioning the use of any such Intellectual Property or the validity or effectiveness of any such Intellectual Property, nor does any Credit Party know of any such claim, and, to the knowledge of each Credit Party, the use of such Intellectual Property by does not infringe on the rights of any Person.

 

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

 

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4.16                         Insurance .  The assets, properties and business of the Credit Parties are insured against such hazards and liabilities, under such coverages and in such amounts, as are customarily maintained by prudent companies similarly situated and under policies issued by insurers of recognized responsibility.

 

4.17                         Material Contracts .  To the knowledge of the Borrower, each Material Contract is in full force and effect and is enforceable by each Consolidated Entity that is a party thereto in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws, statutes or rules of general application affecting the enforcement of creditor’s rights or general principles of equity, and no Consolidated Entity or, to the knowledge of any Consolidated Entity, any other party thereto is in material breach of or default under any Material Contract or has given notice of termination or cancellation of any Material Contract.

 

4.18                         ERISA .

 

(a)                                  The Borrower and each member of the Controlled Group have fulfilled their obligations under the minimum funding standards of ERISA and the Code with respect to each Plan.  The Borrower and each member of the Controlled Group are in compliance in all material respects with the presently applicable provisions of ERISA and the Code, and have not incurred any liability to the PBGC or a Plan under Title IV of ERISA.

 

(b)                                  Neither the Borrower nor any member of the Controlled Group has incurred any withdrawal liability with respect to any Multiemployer Plan under Title IV of ERISA, and no such liability is expected to be incurred.

 

(c)                                   Neither the Borrower nor any member of the Controlled Group has participated in a prohibited transaction, as defined in Section 406 of ERISA or Section 4975(c) of the Code, which is reasonably expected to subject either the Borrower or a member of the Controlled Group to any material civil penalty under ERISA or material tax under the Code.

 

4.19                         Labor Relations .  No Consolidated Entity is engaged in any unfair labor practice within the meaning of the National Labor Relations Act of 1947.  There is (i) no unfair labor practice complaint before the National Labor Relations Board, or grievance or arbitration proceeding arising out of or under any collective bargaining agreement, pending or, to the knowledge of any Credit Party, threatened, against any Consolidated Entity; (ii) no strike, lock-out, slowdown, stoppage, walkout or other labor dispute pending or, to the knowledge of any Credit Party, threatened, against any Consolidated Entity; (iii) to the knowledge of any Credit Party, no petition for certification or union election or union organizing activities taking place with respect to any Consolidated Entity; and (iv) no collective bargaining agreement or Multiemployer Plan covering the employees of any Consolidated Entity.

 

4.20                         No Default .  No Default has occurred and is continuing.

 

4.21                         First Priority Liens .  As of the Purchase Date, subject to completion of the items set forth in Section 5.13, the filing of financing statements in the appropriate form in the jurisdictions of organization of the Credit Parties, the filing of grants of security interests with

 

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

 

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the U.S. Patent and Trademark Office or the U.S. Copyright Office, as applicable, and the delivery of collateral as required pursuant to Section 4.4 of the Security Agreement, except for Permitted Liens, this Agreement, together with the Security Documents, will create valid, perfected, first-priority security interests in such of the collateral in which a security interest can be perfected under Article 9 of the UCC by the filing or by possession thereof or by the actions taken pursuant to Section 5.13 , in each case enforceable against the Credit Parties and securing the payment of all obligations purported to be secured thereby.

 

4.22                         OFAC; Anti-Terrorism Laws .

 

(a)                                  Neither the Borrower nor any Affiliate of the Borrower (i) is a Sanctioned Person, (ii) has more than 10% of its assets in Sanctioned Countries or (iii) derives more than 10% of its operating income from investments in, or transactions with, Sanctioned Persons or Sanctioned Countries.  No part of the proceeds of any Note hereunder will be used directly or indirectly to fund any operations in, finance any investments or activities in or make any payments to, a Sanctioned Person or a Sanctioned Country.

 

(b)                                  Each Consolidated Entity is in compliance in all material respects with the PATRIOT Act.  No part of the proceeds of the Notes hereunder will be used, directly or indirectly, for any payments to any governmental official or employee, political party, official of a political party, candidate for political office, or anyone else acting in an official capacity, in order to obtain, retain or direct business or obtain any improper advantage, in violation of the United States Foreign Corrupt Practices Act of 1977.

 

ARTICLE V

 

AFFIRMATIVE COVENANTS

 

Until payment in full of all Obligations (other than contingent indemnification obligations), the Borrower will, and will cause its Subsidiaries to:

 

5.1                                Financial and Business Information .  Deliver to the Purchasers:

 

(a)                                  Within 45 days after the close of each fiscal quarter (excluding the last fiscal quarter of each fiscal year) of the Consolidated Entities commencing with the fiscal quarter ending June 30, 2015, a consolidated balance sheet of the Consolidated Entities as of the close of such fiscal quarter and consolidated statements of income and cash flows for the Consolidated Entities for the fiscal quarter then ended and for that portion of the fiscal year then ended, including the notes to each, all in reasonable detail setting forth in comparative form the corresponding figures for the corresponding period or periods of (or in the case of the balance sheet, as of the end of) the preceding fiscal year, certified by the Borrower’s present or chief financial officer as presenting fairly in all material respects the financial condition and results of operations of the Consolidated Entities on a consolidated basis in accordance with GAAP consistently applied, subject only to audit and year-end adjustments and the absence of footnotes;

 

(b)                                  Within 90 days after the close of each fiscal year of the Consolidated Entities, an audited consolidated balance sheet of the Consolidated Entities as of the close of such fiscal year and audited consolidated statements of income and cash flows for the Consolidated Entities for

 

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

 

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the fiscal year then ended, including the notes to each, all in reasonable detail setting forth in comparative form the corresponding figures for the preceding fiscal year, accompanied by a report thereon by such certified public accountant containing an opinion that is not qualified with respect to scope limitations imposed by the Consolidated Entities to the effect that such consolidated financial statements present fairly in all material respects the financial condition and results of operations of the Borrower and its Subsidiaries on a consolidated basis in accordance with GAAP consistently applied; and

 

(c)                                   Within a reasonable time, upon any Purchaser’s request, such other information about the financial condition and operations of the Consolidated Entities as the Purchasers may from time to time reasonably request.

 

Any financial statement, report or notice required to be furnished pursuant to this Section 5.1 shall be deemed to have been furnished on the date on which and, provided such date is within the period specified, such requirement will be satisfied if, the Borrower files a form, report or other document with the SEC that contains such financial statement or report required hereunder and any officer certification requirement pursuant to this Section 5.1 with regards to any financial statements shall be satisfied if the Borrower files with the SEC the certifications required by Section 906 of the Sarbanes-Oxley Act of 2002 with respect to such financial statements.

 

5.2                                Notice of Certain Events .

 

(a)                                  Promptly upon obtaining knowledge thereof, give notice in writing to the Purchasers of:

 

(i)                                      Any Default;

 

(ii)                                   The occurrence of any circumstance, event or condition that has resulted in, or could reasonably be expected to result in, a Material Adverse Effect;

 

(iii)                                All claims, litigation, arbitration, or administrative or regulatory proceedings that are instituted or threatened against any Consolidated Entity and of a type that would need to be reported in a Form 8-K, 10-K or 10-Q filed with the SEC pursuant to the Securities Act or any notice of alleged infringement received by any Credit Party related to material Intellectual Property of any Credit Party;

 

(iv)                               The receipt of any complaint, notifications or other material correspondence from any Regulatory Agency in the United States, limiting, suspending or revoking any Regulatory Approval or otherwise materially restricting the manufacture or sale of any Material Product;

 

(v)                                  The creation or acquisition by any Consolidated Entity of any Excluded Subsidiary or Excluded Foreign Subsidiary; and

 

(vi)                               Any circumstance, event or condition that has resulted in, or would reasonably be expect to result in, (A) within the United States a recall of any Material

 

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

 

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Product or (B) a material default or event of default under, or the termination or cancellation outside the ordinary course of business of, any Material Contract.

 

(b)                                  Give notice in writing to the Purchasers of any Major Transaction at least [***] prior to the anticipated effective date for such Major Transaction, which notice shall (i) provide reasonable detail with respect to the terms of the transactions pursuant to which such Major Transaction is to be effected, (ii) specify whether such Major Transaction is a Permissible Change of Control and (iii) if such Major Transaction is a Permissible Change of Control, contain a certification from an authorized officer of the Borrower certifying that the requirements for a Permissible Change of Control have been met or would reasonably be expected to be met, including providing such supporting documentation thereof as may be reasonably requested by the Collateral Agent or the Required Purchasers; provided , that if such Major Transaction is not publicly announced in time for the Borrower to comply with the foregoing notice requirement, the Borrower shall give the Purchasers notice of such Major Transaction no later than two days following the public announcement thereof but in no event less than 10 calendar days prior to the effective date of such Major Transaction.

 

Any notice required to be furnished pursuant to Section 5.2(a)  shall be deemed to have been furnished on the date on which and, provided such date is within the period specified, such requirement will be satisfied if, the Borrower files a form, report or other document with the SEC that contains such financial statement or report required hereunder.

 

Notwithstanding anything set forth above to the contrary, if any notice required to be furnished pursuant to Section 5.2(a)  contains material non-public information (any such notice, a “ 5.2(a) Notice ”), the Borrower, instead of delivering such 5.2(a) Notice to all the Purchasers, shall promptly deliver such 5.2(a) Notice to each Purchaser that is not a Restricted Purchaser and promptly notify each Restricted Purchaser in writing or orally that the Borrower desires to deliver to such Restricted Purchaser a 5.2(a) Notice.  Within five Business Days of receipt of such notification, the Restricted Purchaser may either (i) refuse the delivery of such 5.2(a) Notice, in which case the Borrower’s obligations under Section 5.2(a)  with respect to such 5.2(a) Notice and such Restricted Purchaser shall be deemed satisfied, or (ii) enter into good faith negotiations with the Borrower to agree the time period within which the Borrower will make the material non-public information contained in such 5.2(a) Notice publicly available by including such information in a filing with the SEC.  If the Borrower and such Restricted Purchaser agree on such time period, the Borrower shall promptly deliver to such Restricted Purchaser such 5.2(a) Notice and shall include the applicable material non-public information in a public filing with the SEC within such agreed to time period.  The failure to agree on such time period will be deemed to satisfy Borrower’s obligations under Section 5.2(a)  with respect to such 5.2(a) Notice and such Restricted Purchaser.

 

5.3                                Existence; Maintenance of Properties .  (i) Except as permitted under Section 6.1 , maintain and preserve in full force and effect its legal existence, its good standing under the laws of the jurisdiction of its incorporation or formation, as the case may be, and its qualification to do business in every other jurisdiction where the nature of its business or its properties makes such qualification necessary (except where the failure to be so qualified or licensed could not reasonably be expected to have a Material Adverse Effect); and (ii) maintain all material tangible properties in good working order and condition (normal wear and tear and damage by casualty

 

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

 

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excepted) and from time to time make all necessary repairs to and renewals and replacements of such properties, except to the extent that any of such properties are obsolete or are being replaced or, in the good faith judgment of the Borrower, are no longer useful or desirable in the conduct of the business.

 

5.4                                Compliance with Law .  (i) Comply with all material federal, state, local and foreign laws, regulations and orders applicable to any Credit Party or its assets, including all Environmental Laws, (ii) obtain and maintain any and all material licenses, permits, franchises, Governmental Authorizations, Intellectual Property or other rights necessary for the ownership of its properties and the advantageous conduct of its business and as may be required from time to time by applicable law and (iii) maintain each material Regulatory Approval necessary to sell a Material Product within the United States, except in the case of (i) or (ii) where the failure to do so, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

 

5.5                                Payment of Obligations .  (i) Pay, discharge or otherwise satisfy at or before maturity all liabilities and obligations as and when due (subject to any applicable subordination, grace and notice provisions), except to the extent failure to do so, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect; and (ii) pay when due all material taxes, assessments and other governmental charges imposed upon it or its assets, franchises, business, income or profits before any penalty or interest accrues thereon, and all claims (including claims for labor, services, materials and supplies) for sums that by law might be secured by a Lien (other than a Permitted Lien) or charge upon any of its assets other than any tax, assessment or charge that is being diligently contested in good faith for which adequate reserves have been established in accordance with GAAP.

 

5.6                                Maintenance of Books and Records; Inspection .  Maintain proper books of accounts and records and enter therein complete and accurate entries and records of all of its transactions in accordance with GAAP and give representatives of the Purchasers access thereto during normal business hours upon not less than five Business Days’ notice (but no more than once annually unless an Event of Default has occurred and is continuing), including permission to (i) examine, copy and make abstracts from any such books and records or other information reasonably requested by any Purchaser from time to time and (ii) communicate directly with any Consolidated Entity’s officers or accountants with respect to the business, financial conditions and other affairs of any Consolidated Entity.

 

5.7                                Maintenance of Insurance .  At its own cost, obtain and maintain insurance against (i) loss, destruction or damage to its properties and business of the kinds and in the amounts customarily insured against by corporations with established reputations engaged in the same or similar business as the Credit Parties and (ii) public liability and third-party property damage of the kinds and in the amounts customarily insured against by companies with established reputations engaged in the same or similar business as the Credit Parties.  All such policies shall be (x) issued by financially sound and reputable insurers, and (y) after the time period set forth in Section 5.13(c) , name the Collateral Agent as an additional insured and, where applicable, as loss payee under a lender loss payable endorsement reasonably satisfactory to the Collateral Agent and provide for [***] written notice to the Collateral Agent before such policy is altered or canceled.  After the time period set forth in Section 5.13(c) , all of the insurance policies

 

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

 

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required hereby shall be evidenced by one or more certificates of insurance delivered to the Purchasers by the Borrower as the Collateral Agent may otherwise reasonably request from time to time.  If an Event of Default has occurred and is continuing, in the event of casualty loss with respect to any collateral granted under the Security Documents, the Collateral Agent, as mortgagee, loss payee or additional insured, as appropriate to the policy, may make proof of loss if not made promptly by the Credit Parties, and each insurance company concerned shall hereby be authorized and directed to make payment for such loss directly to the Collateral Agent instead of to any Credit Party and the Collateral Agent jointly.

 

5.8                                ERISA .

 

(a)                                  Cause each member of its Controlled Group to comply in all material respects with ERISA and the Code and the regulations and requirements of the PBGC, except where the necessity of such compliance is being contested in good faith through appropriate proceedings.

 

(b)                                  Cause each member of its Controlled Group to make timely payment of contributions required to meet the minimum funding standards set forth in ERISA and the Code with respect to any Plan, and not take any action or fail to take action the result of which action or inaction could be a material liability for the Borrower or a member of the Controlled Group to the PBGC or a Multiemployer Plan.  Neither the Borrower nor a member of the Controlled Group will participate in a prohibited transaction, as defined in Section 406 of ERISA or Section 4975(c) of the Code that is reasonably expected to subject either the Borrower or a member of the Controlled Group to any material civil penalty under ERISA or material tax under the Code.

 

5.9                                Creation or Acquisition of Subsidiaries .  If the Borrower or any of its Subsidiaries at any time creates or acquires a Subsidiary (other than an Excluded Subsidiary and subject to Section 5.9(c)  in the case of any Excluded Foreign Subsidiary) or if any Excluded Subsidiary or Excluded Foreign Subsidiary fails to qualify as such any time after its creation or acquisition:

 

(a)                                  Concurrently with (and in any event within [***] (or [***] in the event of a Foreign Subsidiary) or in either case such later date as may be agreed upon by the Collateral Agent, after) the creation or direct or indirect acquisition by the Borrower thereof or failure thereof to so qualify, (i) each such Subsidiary will execute and deliver to the Collateral Agent and the Purchasers (A) a joinder to the Guaranty in form and substance satisfactory to the Collateral Agent (B) a joinder to the Security Agreement and an IP Security Agreement in form and substance satisfactory to the Collateral Agent and (C) a Mortgage with respect to any owned interests of such Subsidiary in real property having a value in excess of [***] and (ii) the Borrower will, or will cause the parent Subsidiary that owns the Capital Stock of such Subsidiary to, execute and deliver to the Collateral Agent an amendment or supplement to the Security Agreement pursuant to which all of the Capital Stock of such Subsidiary shall be pledged to the Collateral Agent, together with the certificates, if any, evidencing such Capital Stock, along with undated stock powers duly executed in blank;

 

(b)                                  Concurrently with (and in any event within [***] (or [***] in the event of a Foreign Subsidiary) or in either case such later date as may be agreed upon by the Collateral Agent, after) the creation or direct or indirect acquisition by the Borrower thereof or failure thereof to so qualify, the Borrower will deliver to the Collateral Agent and the Purchasers:

 

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

 

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(i)                                      a written legal opinion of counsel to such Subsidiary addressed to the Collateral Agent and the Purchasers, in form and substance reasonably satisfactory to the Required Purchasers;

 

(ii)                                   (A) a copy of the articles or certificate of incorporation, certificate of formation or other organizational document of such Subsidiary, certified as of a date that is acceptable to the Collateral Agent by the Secretary of State (or comparable Governmental Authority) of its jurisdiction of organization, (B) a copy of the bylaws, operating agreement or similar governing document of such Subsidiary, certified on behalf of such Subsidiary as of a date that is reasonably acceptable to the Collateral Agent by the secretary or an assistant secretary of such Subsidiary, (C) an original certificate of good standing (or equivalent certification if available in the case of a Subsidiary that is organized in a jurisdiction outside the United States) for such Subsidiary issued by the Secretary of State (or comparable Governmental Authority) of its jurisdiction of organization and (D) copies of resolutions adopted by the board of directors (or similar governing body) of such Subsidiary authorizing the execution, delivery and performance of the agreements, documents and instruments executed pursuant to Section 5.9(a) , certified on behalf of such Subsidiary by the secretary or an assistant secretary of such Subsidiary (or equivalent officer), all in form and substance reasonably satisfactory to the Collateral Agent;

 

(iii)                                a report of Uniform Commercial Code financing statement, tax and judgment lien searches (or equivalent searches to the extent available for jurisdictions outside the United States) performed against such Subsidiary in each jurisdiction in which such Subsidiary is incorporated or organized, has a place of business or maintains any assets, which report shall show no Liens on its assets (other than Permitted Liens);

 

(iv)                               a certificate of the secretary or an assistant secretary (or equivalent officer) of such Subsidiary as to the incumbency and signature of the officers executing agreements, documents and instruments executed pursuant to Sections 5.9(a)  and 5.9(b) ;

 

(v)                                  evidence satisfactory to the Required Purchasers that no Default or Event of Default shall exist immediately before or after the creation or acquisition of such Subsidiary or be caused thereby; and

 

(vi)                               a certificate executed by the secretary or an assistant secretary of each of the Borrower and such Subsidiary, which shall constitute a representation and warranty by the Borrower and such Subsidiary as of the date of the creation or acquisition of such Subsidiary that all conditions contained in this Agreement and each other Credit Document to such creation or acquisition have been satisfied, in form and substance reasonably satisfactory to the Collateral Agent;

 

(c)                                   Notwithstanding the foregoing provisions of this Section 5.9 , with respect to any Excluded Foreign Subsidiary, (i) no Capital Stock of such Excluded Foreign Subsidiary will be required to be pledged except to the extent (and only to the extent) that both (y) such Excluded Foreign Subsidiary is not a Subsidiary of another Excluded Foreign Subsidiary and (z) such pledge does not exceed 65% of the total combined voting power of all outstanding classes of

 

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

 

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Capital Stock of such Excluded Foreign Subsidiary entitled to vote (within the meaning of Section 1.956-2(c)(2) of the Treasury Regulations), and (ii) such Excluded Foreign Subsidiary will not be required to become a Subsidiary Guarantor.

 

5.10                         Name Change .  In the case of a Credit Party, notify the Collateral Agent at least 30 days prior to the effective date of any change of its name.  The Credit Parties hereby authorize any required amended or new UCC financing statements and other documents necessary to maintain and continue the perfected security interests of the Purchasers in all of its collateral granted under the Security Documents and agree to take such other actions and execute such documents as the Purchasers shall reasonably require as a result of any change in the name of a Credit Party.

 

5.11                         OFAC, PATRIOT Act Compliance .  Refrain from doing business in a Sanctioned Country or with a Sanctioned Person in violation of the economic sanctions of the United States administered by OFAC and provide, to the extent commercially reasonable, such information and take such actions as are reasonably requested by the Purchasers in order to assist the Purchasers in maintaining compliance with the PATRIOT Act.

 

5.12                         Further Assurances .  Execute, acknowledge and deliver, or cause to be executed, acknowledged or delivered, any and all such further assurances and other agreements or instruments, and take or cause to be taken all such other action, as shall be reasonably necessary from time to time to give full effect to the Credit Documents and the transactions contemplated thereby.  Notwithstanding anything to the contrary herein or in any other Credit Document, no Credit Party shall have any obligation to (A) enter into control agreements with respect to any security interest or lien in any Excluded Account, (B) perfect any security interest or lien in any intellectual property in any jurisdiction other than in the United States, (C) to obtain any landlord waivers, estoppels or collateral access letters (other than with regards to the corporate headquarters of the Borrower or to the extent required pursuant to Section 4.9 of the Security Agreement), provided that no such waiver, estoppel or collateral access letter shall be required if, after using commercially reasonable efforts, the Credit Party are unable to obtain such waiver, estoppel or collateral access letter, (D) perfect a security interest in any letter of credit rights, other than the filing of a UCC financing statement, or (E) delivery any leasehold mortgages with regards to leased property.

 

5.13                         Post-Closing Obligations .  The Borrower will use commercially reasonable efforts to deliver to the Collateral Agent and the Purchasers (in form and substance satisfactory to the Required Purchasers), as soon as practicable following the date hereof, but in any event not later than the dates set forth below (it being understood and agreed that the Required Purchasers, in their sole discretion, may extend the time period allowed for delivery of any such item):

 

(a)                                  within [***], Deposit Account Control Agreements with respect to the deposit accounts listed (or required to be listed) on Annex G to the Security Agreement and control agreements with respect to securities accounts listed on Annex H to the Security Agreement, in each case other than Excluded Accounts and Excluded Securities Accounts (as defined in the Security Agreement) (and for the avoidance of doubt, nothing contained in this Section shall be deemed to waive any of the provisions of Section 4.7 of the Security Agreement);

 

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

 

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(b)                                  within [***], the Landlord Agreement, duly completed and executed by each of the parties thereto; and

 

(c)                                   within [***] of the Purchase Date, evidence that all of the requirements of Section 5.7 have been satisfied, including receipt of certificates of insurance evidencing the insurance coverages required thereunder and naming the Collateral Agent as loss payable or additional insured, as its interests may appear.

 

ARTICLE VI

 

NEGATIVE COVENANTS

 

Until payment in full of all Obligations (other than contingent indemnification obligations), the Borrower will not, and will cause its Subsidiaries (excluding Depo DR, other than for purposes of Section 6.9 ) to not:

 

6.1                                Liquidate; Merger .  Liquidate, or merge or consolidate with any Person, except that (i) any Consolidated Entity that is not a Credit Party may liquidate or dissolve, (ii) any Consolidated Entity may merge or consolidate with another Person in connection with a Major Transaction, and (iii) if not in connection with a Major Transaction, (A) the Borrower may merge or consolidate with another Person so long as the Borrower is the surviving corporation, and (B) any Consolidated Entity other than the Borrower may merge or consolidate with any other Person so long as either (x) the surviving entity is a Subsidiary of the Borrower and if such Consolidated Entity was a Credit Party (or required by this Agreement to be a Credit Party), the surviving Person of such merger or consolidation is a Credit Party (or will become a Credit Party within the time periods required under Section 5.9 ), or (y) such merger or consolidation is effected in connection with a disposition (including any Asset Disposition) of such Consolidated Entity not otherwise prohibited under this Agreement following which such Consolidated Entity ceases to be a Consolidated Entity.

 

6.2                                Indebtedness .  Directly or indirectly issue, assume, create, incur or suffer to exist any Indebtedness, except for:

 

(i)                                      Indebtedness of the Credit Parties in favor of the Collateral Agent and the Purchasers incurred under the Credit Documents;

 

(ii)                                   Indebtedness existing as of the date hereof and described in Schedule 6.2 and any renewals, replacements, refinancings or extensions of any such Indebtedness that do not increase the outstanding principal amount thereof (other than by an amount equal to accrued and unpaid interest and premium thereon, including tender premium, and any underwriting discounts, fees, commissions and expenses associated with such renewal, replacement, refinancings and extensions) or result in an earlier final maturity date or decreased weighted average life thereof;

 

(iii)                                Capital Lease Obligations and purchase money Indebtedness of the Borrower or any Subsidiary thereof incurred solely to finance the acquisition, installation, construction or improvement of any equipment, real property or other fixed assets (and any renewals, replacements, refinancings or extensions thereof); provided that all such

 

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

 

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Indebtedness does not exceed $25,000,000 in aggregate principal amount outstanding at any time;

 

(iv)                               Indebtedness for borrowed money to a Person that is not an Affiliate of a Consolidated Entity under a working capital or revolving credit facility that is secured solely by accounts receivables and inventory of the Consolidated Entities (and the products and proceeds thereof); provided , that (A) all such Indebtedness is on customary market terms, including with respect to the interest rate thereon (B) each provider of such Indebtedness shall have entered into an intercreditor agreement with the Collateral Agent on terms reasonably satisfactory to the Collateral Agent, and (C) the aggregate principal amount outstanding at any time under all such Indebtedness does not exceed (x) if the maximum borrowing availability under the documentation governing all such Indebtedness is less than or equal to $30,000,000 , 85% of the accounts receivables and inventory of the Consolidated Entities (determined on a consolidated basis in accordance with GAAP), (y) if the maximum borrowing availability under the documentation governing all such Indebtedness is greater than $30,000,000 but less than or equal to $40,000,000, 80% of the accounts receivables and inventory of the Consolidated Entities (determined on a consolidated basis in accordance with GAAP), and (z) if the maximum borrowing availability is greater than $40,000,000, 75% of the accounts receivables and inventory of the Consolidated Entities (determined on a consolidated basis in accordance with GAAP);

 

(v)                                  Indebtedness of the Borrower or any Subsidiary under Hedge Agreements entered into in the ordinary course of business to manage existing or anticipated interest rate or foreign currency risks and not for speculative purposes;

 

(vi)                               Indebtedness of the Borrower or any Subsidiary thereof incurred in the ordinary course of business in respect of (A) performance, bid and surety bonds and completion guarantees, or (B) surety (or similar) bonds, letters of credit and performance bonds obtained solely in connection with workers’ compensation obligations of the Consolidated Entities;

 

(vii)                            unsecured loans and advances (A) by the Borrower or any Subsidiary to any Subsidiary Guarantor, (B) by any Subsidiary to the Borrower and (C) by any Credit Party to any Subsidiary that is not a Credit Party; provided , that in the case of this clause (C) such loans and advances are permitted under Section 6.4(vi)  or 6.4(xvii) ;

 

(viii)                         Indebtedness of Subsidiaries that are not Subsidiary Guarantors (other than Depo DR) not to exceed $5,000,000 in aggregate principal amount outstanding at any time;

 

(ix)                               letters of credits, banker’s acceptances and other similar instruments incurred in the ordinary course of business, which may be secured by cash and Cash Equivalents, not to exceed $10,000,000 in aggregate principal amount outstanding at any time;

 

(x)                                  Indebtedness of any Future Acquisition Subsidiary that is assumed or incurred in connection with the related Permitted Acquisition (which Indebtedness may be secured by Lien that are senior to the Liens hereunder); provided that (A) neither the

 

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

 

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Borrower nor any other Subsidiary of the Borrower shall be in any way obligated with respect to such Indebtedness; and (B) the holder(s) or the agent for the holders of such Indebtedness shall have entered into an intercreditor agreement with the Collateral Agent, on terms reasonably satisfactory to the Collateral Agent;

 

(xi)                               the Convertible Notes;

 

(xii)                            other unsecured Indebtedness of the Borrower in the form of senior or subordinated convertible notes; provided , that such Indebtedness does not have a maturity date, or provide for any scheduled payment of principal (or scheduled redemption date), earlier than 91 calendar days after the Maturity Date;

 

(xiii)                         Deferred Acquisition Consideration not relating to the Acquisition, any acquisition consummated prior to the date hereof or a Permitted Acquisition in an amount not to exceed [***] at any time; and

 

(xiv)                        ACH Indebtedness and Indebtedness owed in respect of business credit card programs and any netting services, overdrafts and related liabilities arising from treasury, depository and cash management services;

 

(xv)                           Obligations of Depo DR under the [***];

 

(xvi)                        Indebtedness consisting of (i) the financing of insurance premiums with the providers of such insurance or their affiliates or (ii) take-or-pay obligations contained in supply agreements, in each case, in the ordinary course of business;

 

(xvii)                     Indebtedness incurred in connection with judgments, decrees, attachments or awards that do not constitute an Event of Default;

 

(xviii)                  Indebtedness in the form of an intercompany note issued in connection with a Permitted Acquisition involving a tender offer followed by a short form merger (i.e. a statutory short form merger that requires no further approvals to consummate); provided that (i) such short form merger is consummated within five Business Days of the incurrence of such Indebtedness and (ii) not later than three Business Days after consummation of the related short form merger, such Indebtedness (x) is extinguished or retired or (y) otherwise becomes a permitted Investment; and

 

(xix)                        guarantees of Indebtedness otherwise permitted hereunder except for Indebtedness permitted under Sections 6.2(viii) , 6.2(x)  and 6.2(xv) .

 

6.3                                Liens and Encumbrances .  Create, assume or suffer to exist any Lien in or on any of its property, real or personal, whether now owned or hereafter acquired, except for (collectively, the “ Permitted Liens ”):

 

(i)                                      Liens in favor of the Collateral Agent or the Purchasers created by or otherwise existing under or in connection with the Credit Documents;

 

(ii)                                   Liens in existence as of the date hereof and set forth on Schedule 6.3 ;

 

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

 

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(iii)                                Liens securing Indebtedness permitted under Section 6.2(iii) ; provided that (A) the amount of the Indebtedness secured by such Lien shall not exceed 100% of the cost to the Consolidated Entities of acquiring, constructing, installing and/or improving the property and any other assets then being financed solely by the same financing sources and (B) any such Lien shall not encumber any other property of any Consolidated Entity except assets then being financed solely by the same financing sources;

 

(iv)                               Liens securing Indebtedness permitted under Section 6.2(iv) ; provided that (A) any such Lien shall attach only to the accounts receivables and inventory of the Credit Parties (and the products and proceeds thereof), and (B) the Collateral Agent shall have a second-priority lien on all such accounts receivables and inventory (and the products and proceeds thereof);

 

(v)                                  Liens and other credit support provided in respect of Indebtedness permitted under Section 6.2(v) ; provided , that any such Lien shall attach only to cash and Cash Equivalents;

 

(vi)                               Liens securing Indebtedness permitted under Section 6.2(ix) ; provided that any such Lien shall attach only to the cash and Cash Equivalents of the Consolidated Entities pledged to secure such Indebtedness;

 

(vii)                            Liens securing Indebtedness permitted under Section 6.2(x) , provided (A) any such Lien shall have attached prior to or substantially concurrently with the related Permitted Acquisition, (B) such Liens shall attach only to the assets of the Future Acquisition Subsidiary incurring such Indebtedness, and (C) the Collateral Agent shall have a second lien on all such assets securing such Indebtedness;

 

(viii)                         Liens arising under the [***];

 

(ix)                               Liens imposed by mandatory provisions of law of landlords, carriers, warehousemen, bailees, mechanics and materialmen incurred in the ordinary course of business for sums that are (A) not yet more than 30 days past due or (B) being contested in good faith by appropriate proceedings;

 

(x)                                  Liens (other than those imposed by ERISA) incurred in the ordinary course of business in connection with worker’s compensation, unemployment insurance or other forms of governmental insurance or benefits, insurance, surety bonds, or other obligations of a like nature or to secure the performance of letters of credit, banker’s acceptances, bids, tenders, statutory obligations, leases and contracts (other than for borrowed money) entered into in the ordinary course of business;

 

(xi)                               Liens for current taxes, assessments or other governmental charges that are not delinquent or remain payable without any penalty or that are being contested in good faith and with due diligence by appropriate proceedings and for which adequate reserves have been established in accordance with GAAP;

 

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

 

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(xii)                            Liens of judgments, execution, attachment or similar process that do not constitute an Event of Default under Section 7.1(i) ;

 

(xiii)                         (A) customary banker’s liens and rights of setoff, revocation, refund or chargeback under deposit agreements with financial institutions where any Credit Party maintains deposits or investments` in the ordinary course of business, and (B) customary Liens incurred to secure ACH Indebtedness, business credit card programs, and netting services, overdrafts and related liabilities arising from treasury, depositary and cash management services;

 

(xiv)                        Liens arising under Article 4 of the UCC on items in collection and documents and proceeds related thereto;

 

(xv)                           with respect to any real property occupied by any Credit Party, (i) all survey exceptions, easements, rights of way, reservations, licenses, encroachments, variations and similar restrictions, charges and encumbrances on title that do not secure monetary obligations and do not materially impair the use of such property for its intended purposes or the value thereof and (ii) any other Lien or exception to coverage described in mortgagee policies of title insurance issued in favor of, and accepted by, the Collateral Agent;

 

(xvi)                        Liens on property (including Capital Stock) existing at the time of acquisition of the property by a Consolidated Entity; provided, that such Liens were in existence prior to such acquisition and not incurred in contemplation of, such acquisition;

 

(xvii)                     Liens on insurance policies, premiums and proceeds thereof, or other deposits, to secure insurance premium financings with respect to unearned premiums and other liabilities to insurance carriers;

 

(xviii)                  Liens on cash, Cash Equivalents or other property arising in connection with the defeasance, discharge or redemption of Indebtedness not otherwise prohibited by Section 6.5(b) ;

 

(xix)                        Liens on specific items of inventory or other goods (and the proceeds thereof) of the Consolidated Entities securing such Person’s obligations in respect of bankers’ acceptances issued or created for the account of such Person to facilitate the purchase, shipment or storage of such inventory or other goods;

 

(xx)                           Liens arising out of conditional sale, title retention, consignment or similar arrangements for the sale of goods entered into in the ordinary course of business;

 

(xxi)                        Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods in the ordinary course of business;

 

(xxii)                     Liens in the nature of the right of setoff in favor of customers, suppliers and service providers to contractual agreements with the Consolidated Entities in the ordinary course of business;

 

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

 

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(xxiii)                  Liens on processing or manufacturing equipment or inventory of the Consolidated Entities granted in the ordinary course of business to the Consolidated Entities’ supplier at which such equipment or inventory is located;

 

(xxiv)                 any encumbrance or restriction (including put and call arrangements) with respect to Capital Stock of any joint venture, minority investment or similar arrangement otherwise permitted hereunder pursuant to any joint venture, shareholders, investor rights or similar agreement;

 

(xxv)                    Liens (i) consisting of deposits or advances made by any Consolidated Entity in connection with any letter of intent or purchase agreement in respect of any Permitted Acquisition or Investment permitted under this Agreement or (ii) consisting of an option or agreement to dispose of any property permitted to be sold pursuant to this Agreement;

 

(xxvi)                 leases, subleases, licenses or sublicenses granted to third parties (a) entered into in the ordinary course of business which do not materially interfere with the conduct of the business of the Consolidated Entities, or (b) that are not otherwise prohibited by this Agreement;

 

(xxvii)              ground leases in respect of real property on which facilities owned or leased by any of the Consolidated Entities are located and other Liens affecting the interest of any landlord (and any underlying landlord) of any real property leased by any Consolidated Entity;

 

(xxviii)   any interest or title of a lessor or licensor under any lease, sublease, license or sublicense entered into by any Consolidated Entity (A) existing on the date hereof (but not created in contemplation hereof), (B) entered into in the ordinary course of its business or (C) entered into in connection with a Permitted Acquisition;

 

(xxix)                 Liens on deposits or other amounts held in escrow to secure payments (contingent or otherwise) payable by any Consolidated Entity with respect to the settlement, satisfaction, compromise or resolution or judgments, litigation, arbitration or other disputes; and

 

(xxx)                    Liens to secure Indebtedness permitted under Section 6.2(xviii)  to the extent applicable corporate law requires such Indebtedness to be secured; provided , that any such Liens are released within three Business Days of the consummation of the related short form merger.

 

6.4                                Investments .  Purchase, own, invest in or otherwise acquire, directly or indirectly, any Indebtedness or Capital Stock of any other Person, or purchase or otherwise acquire or license any portion of the assets, business or properties of another Person, or make or permit to exist any loans, advances or extensions of credit to, or any investment in cash or by delivery of property in, any Person (collectively, “ Investments ”), except for:

 

(i)                                      Investments consisting of cash and Cash Equivalents;

 

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

 

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(ii)                                   Investments consisting of the extension of trade credit, the creation of prepaid expenses, payroll and travel advances, and the purchase of inventory, supplies, equipment and other assets, and licenses, in each case by the Consolidated Entities in the ordinary course of business;

 

(iii)                                Investments of the Borrower or any Subsidiary under Hedge Agreements entered into in the ordinary course of business to manage existing or anticipated interest rate or foreign currency risks and not for speculative purposes;

 

(iv)                               Investments existing as of the date hereof in Subsidiaries;

 

(v)                                  Investments made after the date hereof in Credit Parties (other than a Future Acquisition Subsidiary);

 

(vi)                               Investments made after the date hereof (A) by Credit Parties in Subsidiaries that are not Credit Parties or Future Acquisition Subsidiaries made after the Closing Date in an aggregate amount not exceeding $10,000,000 at any time outstanding for all such Investments and (B) by Subsidiaries that are not Credit Parties in other Consolidated Entities;

 

(vii)                            Permitted Acquisitions;

 

(viii)                         Guarantees permitted under Section 6.2(xix) ;

 

(ix)                               Investments received in connection with the bankruptcy or reorganization of, or settlement of delinquent accounts and disputes with, customers and suppliers, in each case in the ordinary course of business;

 

(x)                                  Investments made as a result of the receipt of non-cash consideration from any disposition of assets to third parties; provided that no more than 25% of the consideration for any Asset Disposition shall consist of non-cash consideration (other than consideration arising from the assumption of liabilities);

 

(xi)                               Investments consisting of forward purchase, call option and accelerated share repurchase and other equity derivative transactions permitted under Section 6.5 ;

 

(xii)                            Investments to the extent the consideration paid therefor consists of Qualified Capital Stock of the Borrower and Investments with the proceeds of a substantially concurrent offering of Qualified Capital Stock of the Borrower;

 

(xiii)                         Investments of any Person in existence at the time such Person becomes a Subsidiary; provided that such Investment was not made in connection with or anticipation of such Person becoming a Subsidiary;

 

(xiv)                        Payments, licenses, advances of expenses and acquisitions of Intellectual Property in connection with (A) research, development and other commercialization agreements or arrangements relating to the Material Products (or new formulation thereof) and any other product or medical device (or new formulation thereof) of the

 

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

 

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Consolidated Entities that has received FDA marketing approval and has current revenue, or (B) products or medical devices acquired in a Permitted Acquisitions pursuant to license, collaboration and other agreements assumed or acquired in connection with such Permitted Acquisition;

 

(xv)                           Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business;

 

(xvi)                        Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; and

 

(xvii)                     any other Investments (including Investments by Credit Parties in Subsidiaries that are not Credit Parties not permitted by Section 6.4(vi) ) so long as (A) the EBITDA of the Borrower for the Test Period most recently ended shall have been greater than $125,000,000 and (B) the amount of such Investment does not exceed the Available Additional Amount immediately prior to the date thereof.

 

6.5                                Restricted Payments .

 

(a)                                  Directly or indirectly, declare or make any dividend payment, or make any other distribution of cash, property or assets, in respect of any of its Capital Stock, or purchase, redeem, retire or otherwise acquire for value any shares of its Capital Stock, or set aside funds for any of the foregoing, except that:

 

(i)                                      the Credit Parties may declare and make dividend payments or other distributions payable solely in its Capital Stock to the extent not prohibited under applicable Requirements of Law;

 

(ii)                                   any Subsidiary of the Borrower may declare and make dividend payments or other distributions to the holders of its Capital Stock; provided that in the case of dividend or other distribution by a non-Wholly Owned Subsidiary, such dividend or distribution shall be made ratably with respect to their Capital Stock or shall be payable solely to the Credit Parties and/or Wholly Owned Subsidiaries of the Credit Parties;

 

(iii)                                the Borrower may make cash payments in lieu of the issuance of fractional shares in connection with the exercise or conversion of warrants, options or other rights to acquire Capital Stock;

 

(iv)                               the purchase, redemption, retirement or other acquisition for value of Capital Stock of the Borrower held by current or former officers, directors, employees or consultants of any Consolidated Entity (or their estates or beneficiaries under their estates) upon death, disability, retirement or termination of employment or alteration of employment status or pursuant to the terms of any agreement under which such Capital Stock was issued; provided, however, that the aggregate cash consideration paid for such purchase, redemption, retirement or other acquisition of such Capital Stock does not exceed $15.0 million in any fiscal year;

 

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

 

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(v)                                  (A) repurchases of Capital Stock deemed to occur upon the cash-less or net exercise of stock options, warrants or other convertible or exchangeable securities and (B) repurchases of Capital Stock deemed to occur upon the withholding of a portion of the Capital Stock granted or awarded to a current or former officer, director, employee or consultant to pay for the taxes payable by such person upon such grant or award (or upon vesting thereof);

 

(vi)                               purchases of Capital Stock of any Subsidiary to the extent permitted as an Investment under Section 6.4 ;

 

(vii)                            the issuance of rights in connection with the adoption of a stockholders’ rights plan approved by the Borrower’s board of directors; and

 

(viii)                         purchases of Capital Stock of the Borrower (or any forward purchase, accelerated share purchase, capped call, call option or other equity derivatives) and the settlement or termination of any forward purchase, accelerated share purchase, capped call, call option or other equity derivatives so long as (A) the EBITDA of the Borrower for the Test Period most recently ended shall have been greater than $125,000,000 and (B) the amount of such purchase, settlement or termination does not exceed the Available Additional Amount immediately prior to the date thereof.

 

(b)                                  Directly or indirectly, make any voluntary prepayment of principal on, or interest, fees or premium (if any) with respect to, the Convertible Notes or any Indebtedness permitted under Section 6.2(xii) , or directly or indirectly make any redemption (including pursuant to any change of control or asset disposition provision), retirement, defeasance or other acquisition for value of the Convertible Notes or any Indebtedness permitted under Section 6.2(xii) , or make any deposit or otherwise set aside funds for any of the foregoing purposes; except that,

 

(i)                                      the Borrower may make scheduled payments of cash interest with respect to such Indebtedness at the non-default rate of interest (plus any additional interest payable with respect to any Convertible Notes or Indebtedness permitted under Section 6.2(xii)  (x) as a remedy relating to the Borrower’s failure to comply with its reporting obligations thereunder, (y) for any such convertible notes failing to be freely tradable as required by the terms thereof and (z) for the restrictive legend on any such convertible notes failing to have been removed as required by the terms thereof) in effect on the date hereof, with respect to the Convertible Notes, or the date of issuance, with respect to any Indebtedness permitted under Section 6.2(xii) , (but not cash payments of interest previously accrued in-kind) and may accrue (but may not pay in cash) other interest (including interest at the default rate);

 

(ii)                                   upon any conversion of any such Indebtedness by the holders thereof pursuant to its terms, the Borrower may pay or prepay the principal on such Indebtedness subject to such conversion, and interest with respect thereto, but only in Capital Stock of the Borrower ( provided , that any fractional shares of Capital Stock of the Borrower required to be issued in connection with such conversion may be paid in cash);

 

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

 

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(iii)                                the Borrower may settle, repay, redeem or otherwise retire or acquire for value any such Indebtedness in exchange for shares of Qualified Capital Stock;

 

(iv)                               the Borrower may repurchase, redeem or otherwise retire or acquire for value any such Indebtedness with the proceeds of, in exchange for, new Indebtedness incurred pursuant to Section 6.2(xii) ; provided that (1) the aggregate principal amount of such new Indebtedness does not exceed the principal amount so repurchased, redeemed or otherwise retired or acquired for value (plus accrued and unpaid interest thereon), (2) the maturity for the new Indebtedness is no earlier than the later of (A) 91 calendar days after the Maturity Date and (B) the maturity date of the Indebtedness so repurchased, redeemed or otherwise retired or acquired for value, and (3) the stated interest rate for such new indebtedness is no greater than the stated interest rate of the Indebtedness so repurchased, redeemed or otherwise retired or acquired for value;

 

(v)                                  the Borrower may settle, repay, redeem or otherwise retire or acquire for value any such Indebtedness in cash so long as (A) the EBITDA of the Borrower for the Test Period most recently ended shall have been greater than $125,000,000 and (B) the amount to be paid in cash by a Consolidated Entity in connection with such settlement, repayment, redemption, etc. does not exceed the Available Additional Amount immediately prior to the date thereof;

 

(vi)                               the Borrower may repurchase any such Indebtedness upon the occurrence of a “change of control” or “fundamental change” so long as, prior to such repurchase, the Borrower shall have offered to repurchase the Notes at the then applicable optional prepayment price pursuant to Section 2.6 (assuming for such purposes that such “change of control” or “fundamental change” constitutes a Major Transaction) and shall have repurchased any Notes tendered pursuant to such offer.

 

6.6                                Transactions with Related Persons .  Except as expressly permitted by Section 6.5 and Investments permitted by Section 6.4 , enter into any transaction with any Affiliate, except in the ordinary course of business pursuant to the reasonable requirements of the business of the Borrower and on terms substantially no more favorable to such Affiliate than those that such Affiliate would obtain in a comparable arms-length transaction with a Person other than the Borrower or an Affiliate thereof; provided that the foregoing shall not prohibit (a) of customary fees and indemnification provided to directors of the Consolidated Entities, (b) any compensation and indemnification of, and other employment agreements and arrangements, employee benefit plans, and stock incentive plans with, directors, officers and employees of the Consolidated Entities entered in the ordinary course of business, and (c) the granting of registration and other customary rights to holders of the Borrower’s Capital Stock.

 

6.7                                Net Sales .  Commencing with the fiscal quarter ended June 30, 2016, permit Net Sales as of the last day of any fiscal quarter to be less than the amount set forth below opposite such fiscal quarter:

 

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

 

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Fiscal Quarter

 

Net Sales

Fiscal Quarters ended June 30, 2016 and September 30, 2016

 

$

250,000,000

Fiscal Quarters ended December 31, 2016, March 31, 2017, June 30, 2017 and September 30, 2017

 

$

280,000,000

Each Fiscal Quarter Thereafter

 

$

330,000,000

 

6.8                                Lines of Business .  Engage in any business other than the research, development, sale, distribution, manufacture and other commercialization of pharmaceutical products or compounds or medical devices and any business reasonably related, ancillary or incidental thereto.

 

6.9                                Depo DR Assets .  Permit Depo DR to (i) hold any interest in any assets other than its rights under the [***], the assets contributed thereto in connection with the [***], or cash received pursuant thereto, or (ii) engage in any activities or use or distribute any assets other than (A) exercising rights and performing its obligations under the [***], (B) distributing cash received pursuant thereto to a Credit Party or as required under the [***], and (C) any activities ancillary thereto and to the maintenance of its existence and good standing.

 

6.10                         Foreign Subsidiary Transfers .  (i) Other than transactions that are at prices and on terms and conditions not less favorable than could be obtained on an arm’s-length basis from unrelated third parties, with respect to a Credit Party, enter into any transaction with a Foreign Subsidiary pursuant to the terms of which such Credit Party transfers, or is obligated at any time to transfer, cash or assets to such Foreign Subsidiary, except as permitted by Section 6.4(vi)  or 6.4(xvii) , or (ii) with respect to any Consolidated Entity that is not a Foreign Subsidiary, transfer any interest in any Intellectual Property to a Foreign Subsidiary.

 

6.11                         Certain Amendments .  Amend, modify or change any provision of (i) its articles or certificate of incorporation or formation, bylaws, operating agreement or other applicable formation or organizational documents, as applicable, the terms of any class or series of its Capital Stock, or any agreement among the holders of its Capital Stock or any of them or (ii) the terms of the Convertible Notes or any Indebtedness incurred pursuant to Sections 6.2(x)  or 6.2(xii)  after the date such Indebtedness is incurred; in each case other than in a manner that could not reasonably be expected to adversely affect the Purchasers in any material respect; provided that the Borrower may issue such Capital Stock, so long as such issuance is not prohibited by any provision of this Agreement, and may amend or modify its articles of incorporation to authorize any such Capital Stock and/or enter into, amend, modify or otherwise supplement agreements relating to its Capital Stock that are otherwise permitted hereunder.

 

6.12                         Limitation on Certain Restrictions .  Directly or indirectly, create or otherwise cause or suffer to exist or become effective any restriction, encumbrance or condition on (i) the ability of any Subsidiary of the Borrower to make any dividend payment or other distribution in respect of its Capital Stock, to repay Indebtedness owed to the Borrower or any other Subsidiary, to make loans or advances to the Borrower or any other Subsidiary or to transfer any of its assets or properties to the Borrower or any other Subsidiary or (ii) the creation, incurrence or

 

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

 

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assumption of any Lien upon or with respect to any part of the Borrower’s or any of its Subsidiary’s property or assets, whether now owned or hereafter acquired, except (in the case of clauses (ii) and (iii) only) for such restrictions or encumbrances existing under or by reason of (A) the Credit Documents, (B) applicable Requirements of Law, (C) customary restrictions on the transfer or the creation, incurrence or assumption of any Lien contained in any agreement or instrument creating a Lien permitted under Section 6.3 ( provided that such restrictions apply only to the assets subject to such Lien), (D) restrictions and conditions set forth in any agreement governing Indebtedness permitted by Section 6.2(iv)  and restrictions and conditions set forth in the [***], (E) customary non-assignment provisions in agreements, leases and license restricting the assignment or transfer thereof, (F) customary non-assignment provisions in leases and licenses of real or personal property entered into by the Borrower or any Subsidiary as lessee or licensee in the ordinary course of business, restricting the assignment or transfer of property that is the subject thereof, (G) customary restrictions and conditions contained in any agreement relating to the sale of assets (including Capital Stock of a Subsidiary) pending such sale ( provided that such restrictions and conditions apply only to the assets being sold and such sale is permitted under this Agreement), (H) restrictions on cash, other deposits or net worth imposed by customers under contracts entered into in the ordinary course of business, (I) restrictions and conditions imposed by agreements of any Person in existence at the time such Person became a Subsidiary and any amendments or modifications thereof that do not materially expand the scope of any such restriction or condition taken as a whole, provided that such restrictions and conditions apply only to such Person, and (J) any restriction arising under or in connection with any agreement or instrument governing Capital Stock of any joint venture.

 

6.13                         Partnerships .  Acquire a general partnership interest in any legal partnership or other legal entity that does not provide for limited liability of its equity owners.

 

6.14                         Fiscal Year .  Change its fiscal year or its method of determining fiscal quarters (other than in connection with a Permissible Change of Control).

 

6.15                         Accounting Changes .  Other than as permitted pursuant to Section 1.2 , make or permit any material change in its accounting policies or reporting practices, except as may be required by GAAP.

 

ARTICLE VII

 

EVENTS OF DEFAULT; REMEDIES

 

7.1                                Events of Default .  The occurrence of any one or more of the following events shall constitute an Event of Default hereunder:

 

(a)                                  (i) The Borrower shall fail to pay any principal amount when due, or (ii) the Borrower fails to pay any interest, fees or other charges or amounts payable within three Business Days of when due, under this Agreement, the Notes or under any other Credit Document;

 

(b)                                  Any Credit Party shall fail to observe or perform any covenant, restriction or agreement contained in Section 5.1 , 5.2 , 5.3 , 5.9 or 5.13 or Article VI ;

 

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

 

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(c)                                   Any Credit Party shall fail to observe or perform any covenant, restriction or agreement contained in any Credit Document (other than those described in Sections 7.1(a)  and 7.1(b) ) for 30 days after the earlier of the Borrower (i) obtaining knowledge of such failure or (ii) receiving written notice of such failure from the Collateral Agent or the Required Purchasers;

 

(d)                                  Any representation or warranty made or deemed made by any Credit Party in any Credit Document delivered pursuant to any Credit Document shall prove to have been incorrect in any material respect when made or deemed made; provided , that the words “in any material respect” shall not apply to any representation, warranty, certification or statement that contains any qualification with respect to materiality, including a reference to the defined term “Material Adverse Effect;”

 

(e)                                   The occurrence and continuance of any default or event of default on the part of any Credit Party (including defaults due to non-payment) under the terms of any agreement, document or instrument pursuant to which the Credit Parties have incurred any Indebtedness in excess of $20,000,000, or the occurrence of any other event or condition, the effect of which default, event or condition is to cause, or permit the holder or holders of such Indebtedness (or a trustee or agent on its or their behalf) to cause (without the giving of notice, lapse of time, or both), without regard to subordinated terms with respect thereto, such Indebtedness to become due or to be repurchased or redeemed (or an offer to repurchase or redeem such Indebtedness to be made) prior to its stated maturity; provided , that this clause (e) shall not apply to (i) secured Indebtedness that becomes due as a result of the voluntary sale or transfer of the property or assets securing such Indebtedness, (ii) any conversion, exchange or settlement with respect to the Convertible Notes or any other Indebtedness convertible into or exchangeable for Capital Stock pursuant to its terms unless such conversion or settlement results from a default thereunder or an event of the type that constitutes an Event of Default and not otherwise prohibited by Section 6.5(b)  (provided that the Borrower retains the right to settle such conversions, exchange or settlement in Capital Stock (and cash payable for any fractional shares)).

 

(f)                                    Any material provision of the Security Documents shall for any reason cease to be in full force and effect or cease to be effective to give the Collateral Agent a valid and perfected security interest in and Lien upon any portion of the collateral granted under the Security Documents in excess of, individually or in the aggregate, $5,000,000 purported to be covered thereby, subject to Permitted Liens, in each case unless any such cessation occurs in accordance with the terms thereof or is due to any act or failure to act on the part of the Collateral Agent or the Purchasers, or any Consolidated Entity shall assert of the foregoing or deny or disaffirm any Credit Party’s obligations under the Guaranty;

 

(g)                                   Any Consolidated Entity (i) files a petition for relief under the Bankruptcy Code or any other insolvency law or seeking to adjudicate it bankrupt or insolvent, or seeking dissolution, winding up, liquidation, reorganization, arrangement, adjustment or composition of it or its debts under any law relating to bankruptcy, insolvency or reorganization or relief of debtors or fails to file an answer or other pleading denying the material allegations of any such proceeding filed against it, (ii) takes any corporate action to authorize or effect any of the foregoing actions, (iii) generally fails to pay, or admits in writing its inability to pay, its debts as such debts become due; (iv) shall apply for, seek or consent to, or acquiesce in, the appointment of a custodian, receiver, trustee, examiner, liquidator or similar official for it or for any material

 

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

 

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portion of its assets; (v) benefits from or is subject to the entry of an order for relief under any bankruptcy or insolvency law; or (vi) makes an assignment for the benefit of creditors;

 

(h)                                  Failure of any Consolidated Entity within 60 days after the commencement of any proceeding against it seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, to have such proceeding dismissed, or to have all orders or proceedings thereunder affecting the operations or the business of any Consolidated Entity stayed, or failure of any Consolidated Entity within 30 days after the appointment, without its consent or acquiescence, of any custodian, receiver trustee, examiner, liquidator or similar official for it or for any material portion of its assets, to have such appointment vacated; or

 

(i)                                      The entry of one or more judgments or orders for the payment of money in excess of $20,000,000 in the aggregate (excluding any amounts covered by insurance within available limits which the applicable insurer does not deny are covered thereby) against the Consolidated Entities and such judgment(s) or order(s) shall continue unsatisfied and unstayed for a period of 60 days or the issuance of a writ of execution, attachment or similar process against any Consolidated Entity that is not dismissed, stayed, discharged or bonded within 60 days after any Consolidated Entity acquires knowledge thereof.

 

7.2                                Remedies .  Upon the occurrence and during the continuance of any Event of Default:

 

(a)                                  Acceleration of Indebtedness .  The Required Purchasers may declare all or any part of the Notes immediately due and payable, whereupon the Notes shall become immediately due and payable without presentment, demand, protest, notice or legal process of any kind, all of which are hereby expressly waived by the Borrower ( provided , however , that all Notes shall automatically become due and payable upon the occurrence of an Event of Default under Section 7.1(g)  or 7.1(h)  with respect to the Borrower);

 

(b)                                  Other Remedies .  The Collateral Agent may with the approval of the Required Purchasers and shall at the direction of the Required Purchasers pursue all other remedies available to it by contract, at law or in equity, including its rights under the Security Documents.

 

(c)                                   Right of Setoff .  Each Purchaser may, and is hereby authorized by the Borrower to, at any time and from time to time, to the fullest extent permitted by applicable laws, without advance notice to the Borrower (any such notice being expressly waived by the Borrower), set off and apply any and all deposits (general or special, time or demand, provisional or final) at any time held and any other indebtedness at any time owing by such Purchaser or any of its Affiliates to or for the credit or the account of the Borrower against any or all of the Obligations now or hereafter existing, whether or not such obligations have matured.  Each Purchaser agrees promptly to notify the Borrower, each other Purchaser and the Collateral Agent after any such setoff or application; provided , however , that the failure to give such notice shall not affect the validity of such setoff and application.

 

(d)                                  Rights and Remedies Cumulative; Non-Waiver; etc .  The enumeration of the Collateral Agent’s and the Purchasers’ rights and remedies set forth in this Agreement is not

 

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

 

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intended to be exhaustive and the exercise by the Collateral Agent or the Purchasers of any right or remedy shall not preclude the exercise of any other rights or remedies, all of which shall be cumulative, and shall be in addition to any other right or remedy given hereunder, under the other Credit Documents or under any other agreement between the Borrower and the Collateral Agent or the Purchasers or that may now or hereafter exist in law or in equity or by suit or otherwise.  No delay or failure to take action on the part of the Collateral Agent or the Purchasers in exercising any right, power or privilege shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or privilege preclude other or further exercise thereof or the exercise of any other right, power or privilege or shall be construed to be a waiver of any Event of Default.  No course of dealing between the Credit Parties and the Collateral Agent or the Purchasers or their agents or employees shall be effective to change, modify or discharge any provision of this Agreement or any of the other Credit Documents or to constitute a waiver of any Event of Default.

 

(e)                                   Notices to Purchasers .  The Collateral Agent shall deliver to the Purchasers any notice of acceleration received by it pursuant to Section 7.2(a)  and written approval or written direction received by it pursuant to Section 7.2(b) ; provided , that any delivery of or failure to deliver any such notice, approval or direction shall not otherwise alter or effect the rights of the Purchasers or the Collateral Agent under this Section 7.2 .  In addition, to the extent the Collateral Agent or the Required Purchasers deliver any notices to the Borrower with regards to the failure by any Credit Party to perform any covenant, restriction or agreement contained in any Credit Document, the Collateral Agent or the Required Purchasers, as applicable, will also deliver such notice to the other Purchasers on or about the same time such notice is provided to the Borrower; provided, that the delivery of or failure to deliver such notice to the other Purchasers shall not in any way effect the obligations of the Borrower, or the rights of the Collateral Agent or the Required Purchasers, in respect of such notice.

 

ARTICLE VIII

 

THE COLLATERAL AGENT

 

8.1                                Appointment and Authority .  Each of the Purchasers hereby irrevocably appoints Deerfield to act on its behalf as the Collateral Agent hereunder and under the other Credit Documents and authorizes the Collateral Agent to take such actions on its behalf and to exercise such powers as are delegated to the Collateral Agent by the terms hereof or thereof, together with such actions and powers as are reasonably incidental thereto.  Except for the last paragraph of Section 8.8 , the provisions of this Article VIII are solely for the benefit of the Collateral Agent and the Purchasers, and neither the Borrower nor any other Credit Party shall have rights as a third party beneficiary of any of such provisions.  Subject to Section 8.8 and Section 9.10 , any action required or permitted to be taken by the Collateral Agent hereunder shall be taken with the prior approval of the Required Purchasers.

 

8.2                                Rights as a Purchaser .  The Person serving as the Collateral Agent hereunder shall have the same rights and powers in its capacity as a Purchaser as any other Purchaser and may exercise the same as though it were not the Collateral Agent and the term “Purchaser” or “Purchasers” shall, unless otherwise expressly indicated or unless the context otherwise requires, include the Person serving as the Collateral Agent hereunder in its individual capacity.  Such

 

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

 

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Person and its Affiliates may lend money to, own securities of, act as the financial advisor or in any other advisory capacity for and generally engage in any kind of business with the Borrower or any Subsidiary or other Affiliate thereof as if such Person were not the Collateral Agent hereunder and without any duty to account therefor to the Purchasers.

 

8.3                                Exculpatory Provisions .

 

(a)                                  the Collateral Agent shall not have any duties or obligations except those expressly set forth herein and in the other Credit Documents to which it is a party.  Without limiting the generality of the foregoing, the Collateral Agent:

 

(i)                                      shall not be subject to any fiduciary or other implied duties, regardless of whether a Default or Event of Default has occurred and is continuing;

 

(ii)                                   shall not have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and powers expressly contemplated hereby or by the other Credit Documents to which it is a party that the Collateral Agent is required to exercise as directed in writing by the Required Purchasers (or such other number or percentage of the Purchasers as shall be expressly provided for herein or in such other Credit Documents), provided that the Collateral Agent shall not be required to take any action that, in its opinion or the opinion of its counsel, may expose the Collateral Agent to liability or that is contrary to any Credit Document or applicable law; and

 

(iii)                                shall not, except as expressly set forth herein and in the other Credit Documents to which it is a party, have any duty to disclose, and shall not be liable for the failure to disclose, any information relating to the Borrower or any of its Affiliates that is communicated to or obtained by the Person serving as the Collateral Agent or any of its Affiliates in any capacity.

 

(b)                                  The Collateral Agent shall not be liable for any action taken or not taken by it (i) with the consent or at the request of the Required Purchasers (or such other number or percentage of the Purchasers as shall be necessary, or as the Collateral Agent shall believe in good faith shall be necessary, under the circumstances as provided in Section 9.10 ) or (ii) in the absence of its own gross negligence or willful misconduct as determined by a court of competent jurisdiction by final and nonappealable judgment.  The Collateral Agent shall be deemed not to have knowledge of any Default or Event of Default unless and until notice describing such Default or Event of Default is given to the Collateral Agent in writing by the Borrower or a Purchaser.

 

(c)                                   The Collateral Agent shall not be responsible for or have any duty to ascertain or inquire into (i) any statement, warranty or representation made in or in connection with this Agreement or any other Credit Document, (ii) the contents of any certificate, report or other document delivered hereunder or thereunder or in connection herewith or therewith, (iii) the performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the occurrence of any Default or Event of Default, (iv) the validity, enforceability, effectiveness or genuineness of this Agreement, any other Credit Document or any other agreement, instrument or document or (v) the satisfaction of any condition set forth in

 

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

 

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Article III or elsewhere herein, other than to confirm receipt of items expressly required to be delivered to the Collateral Agent.

 

8.4                                Reliance by Collateral Agent .  The Collateral Agent shall be entitled to rely upon, and shall not incur any liability for relying upon, any notice, request, certificate, consent, statement, instrument, document or other writing (including any electronic message, internet or intranet website posting or other distribution) believed by it to be genuine and to have been signed, sent or otherwise authenticated by the proper Person.  The Collateral Agent also may rely upon any statement made to it orally or by telephone and believed by it to have been made by the proper Person, and shall not incur any liability for relying thereon.  The Collateral Agent may consult with legal counsel (who may be counsel for the Borrower), independent accountants and other experts selected by it, and shall not be liable for any action taken or not taken by it in accordance with the advice of any such counsel, accountants or experts.

 

8.5                                Delegation of Duties .  The Collateral Agent may perform any and all of its duties and exercise its rights and powers hereunder or under any other Credit Document by or through any one or more sub-agents appointed by the Collateral Agent.  The Collateral Agent and any such sub-agent may perform any and all of its duties and exercise its rights and powers by or through their respective Related Parties.  The exculpatory provisions of this Article VIII  shall apply to any such sub-agent and to the Related Parties of the Collateral Agent and any such sub-agent.  The Collateral Agent shall not be responsible for the negligence or misconduct of any sub-agent except to the extent that a court of competent jurisdiction determines in a final and nonappealable judgment that the Collateral Agent acted with gross negligence or willful misconduct in the selection of such sub-agent.

 

8.6                                Resignation of Collateral Agent .  The Collateral Agent may at any time give notice of its resignation to the Purchasers and the Borrower.  Upon the receipt of any such notice of resignation, the Required Purchasers shall have the right, in consultation with the Borrower so long as no Default has occurred and is continuing, to appoint a successor.  If no successor shall have been so appointed by the Required Purchasers and shall have accepted such appointment within 30 days after the retiring Collateral Agent gives notice of its resignation, then the retiring Collateral Agent may, on behalf of the Purchasers, appoint a successor Collateral Agent; provided that, whether or not a successor has been appointed or has accepted such appointment, such resignation shall become effective upon delivery of the notice thereof.  Upon the acceptance of a successor’s appointment as Collateral Agent hereunder, such successor shall succeed to and become vested with all of the rights, powers, privileges and duties of the retiring (or retired) Collateral Agent, and the retiring Collateral Agent shall be discharged from all of its duties and obligations under the Credit Documents (if not already discharged therefrom as provided above in this Section 8.6 ).  After the retiring Collateral Agent’s resignation, the provisions of this Article VIII and Section 9.2 shall continue in effect for the benefit of such retiring Collateral Agent, its sub-agents and their respective Related Parties in respect of any actions taken or omitted to be taken by any of them while the retiring Collateral Agent was acting as Collateral Agent.  Upon any resignation by the Collateral Agent, all payments, communications and determinations provided to be made by, to or through the Collateral Agent shall instead be made by, to or through each Purchaser directly, until such time as a Person accepts an appointment as Collateral Agent in accordance with this Section 8.6 .

 

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

 

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8.7                                Non-Reliance on Collateral Agent and Other Purchasers .  Each Purchaser acknowledges that it has, independently and without reliance upon the Collateral Agent or any other Purchaser or any of their Related Parties and based on such documents and information as it has deemed appropriate, made its own credit analysis and decision to enter into this Agreement and purchase the Notes hereunder.  Each Purchaser also acknowledges that it will, independently and without reliance upon the Collateral Agent or any other Purchaser or any of their Related Parties and based on such documents and information as it shall from time to time deem appropriate, continue to make its own decisions in taking or not taking action under or based upon this Agreement, any other Credit Document or any related agreement or any document furnished hereunder or thereunder.

 

8.8                                Collateral and Guaranty Matters .  Each Purchaser agrees that any action taken by the Collateral Agent or the Required Purchasers in accordance with the provisions of this Agreement or of the other Credit Documents, and the exercise by the Collateral Agent or Required Purchasers of the powers set forth herein or therein, together with such other powers as are reasonably incidental thereto, shall be authorized and binding upon all of the Purchasers. Without limiting the generality of the foregoing, the Purchasers irrevocably authorize the Collateral Agent, at its option and in its discretion:

 

(a)                                  to release any Lien on any property granted to or held by the Collateral Agent under any Security Document (A) upon discharge of the Obligations, (B) that is sold, transferred, disposed or to be sold, transferred, disposed as part of or in connection with any sale, transfer o or other disposition (other than any sale to a Credit Party) permitted hereunder or otherwise becomes an Excluded Property (as defined in the Security Agreement), (C) subject to Section 9.10 , if approved, authorized or ratified in writing by the Required Purchasers or (D) to the extent such property is owned by a Subsidiary Guarantor upon the release of such Subsidiary Guarantor from its obligations under its Guaranty pursuant to clause (c) below;

 

(b)                                  to subordinate any Lien on any property granted to or held by the Collateral Agent under any Loan Document to the holder of any Lien on such property that is permitted by clause (iii), (iv), (v), (vi), (vii), (x), (xvi), (xviii), (xix), (xx), (xxi), (xxv) or (xxvi) of Section 6.3 ;

 

(c)                                   to release any Subsidiary Guarantor from its obligations under the Guaranty Agreement if such Person ceases to be a Subsidiary or becomes an Excluded Subsidiary as a result of a transaction permitted hereunder;

 

(d)                                  to enter into non-disturbance and similar agreements in connection with the licensing of Intellectual Property permitted pursuant to the terms of this Agreement; and

 

(e)                                   to enter into an intercreditor agreement as contemplated by Section 6.2(iv)  or 6.2(x) .

 

Upon request by the Collateral Agent at any time the Required Purchasers will confirm in writing the Collateral Agent’s authority to release or subordinate its interest in particular types or items of property, or to release any Subsidiary Guarantor from its obligations under the Guaranty pursuant to this Section 8.8 .

 

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

 

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In each case as specified in this Section 8.8 , the Collateral Agent will (and each Purchaser irrevocably authorizes the Collateral Agent to), at the Borrower’s expense, execute and deliver to the applicable Credit Party such documents as such Credit Party may reasonably request (i) to evidence the release or subordination of such item of collateral from the assignment and security interest granted under the Security Documents, (ii) to enter into non-disturbance or similar agreements in connection with the licensing of Intellectual Property, (iii) to enter into an intercreditor agreement as contemplated by Section 6.2(iv)  or 6.2(x)  or (iv) to evidence the release of such Subsidiary Guarantor from its obligations under the Guaranty, in each case in accordance with the terms of the Credit Documents and this Section 8.8 and in form and substance reasonably acceptable to the Collateral Agent.

 

The Collateral Agent shall deliver to the Purchasers notice of any action taken by it under this Section 8.8 as soon as reasonably practicable after the taking thereof; provided , that delivery of or failure to deliver any such notice shall not affect the Collateral Agent’s rights, powers, privileges and protections under this Article VIII .

 

8.9                                Reimbursement by Purchasers .  To the extent that the Borrower for any reason fails to indefeasibly pay any amount required under Section 9.1 or 9.2 to be paid by it to the Collateral Agent (or any sub-agent thereof) or any Related Party of any of the foregoing, each Purchaser severally agrees to pay to the Collateral Agent (or any such sub-agent) or such Related Party, as the case may be, such Purchaser’s pro rata share (based upon the percentages as used in determining the Required Purchasers as of the time that the applicable unreimbursed expense or indemnity payment is sought) of such unpaid amount; provided that the unreimbursed expense or indemnified loss, damage, liability or related expense, as the case may be, was incurred by or asserted against the Collateral Agent (or any such sub-agent) in its capacity as such or against any Related Party of any of the foregoing acting for the Collateral Agent (or any sub-agent) in connection with such capacity.

 

ARTICLE IX

 

MISCELLANEOUS

 

9.1                                Costs and Expenses .  The Borrower agrees to pay on demand all reasonable and documented out-of-pocket expenses of the Collateral Agent and the Purchasers, including reasonable fees and disbursements of counsel, in connection with:  (i) the preparation, execution, delivery, and filing, if required of this Agreement and the other Credit Documents (provided that the obligation to reimburse under clause (i) shall not exceed [***]), (ii) any amendments, supplements, consents or waivers hereto or to the other Credit Documents and (iii) the administration or enforcement of this Agreement and the other Credit Documents.  In addition, the Borrower shall pay any Other Taxes in accordance with Section 2.11(b) .

 

9.2                                Indemnification .  From and at all times after the date of this Agreement, and in addition to all of the Collateral Agent’s and the Purchasers’ other rights and remedies against the Borrower, the Borrower agrees to indemnify, defend and hold harmless the Collateral Agent and the Purchasers and their respective Related Parties from and against all damages, losses and other out-of-pocket costs and expenses of any kind or nature whatsoever (including reasonable attorneys’ fees and expenses, court costs and fees, and consultant and expert witness fees and

 

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

 

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expenses, but limited in the case of attorney’s fees and expenses to the reasonable and documented out of pocket fees, disbursements and other charges of one counsel to the indemnified parties, taken as a whole and if reasonably necessary, one local counsel in each appropriate jurisdiction (and, in the case of a conflict of interest, where the indemnitee affected by such conflict notifies the Borrower of the existence of such conflict and thereafter retains its own counsel, one additional separate counsel for all similarly affected indemnitees) (collectively “Costs”) arising in any manner, directly or indirectly, out of or by reason of any and all claims (whether valid or not), actions, suits, inquiries, investigations and administrative proceedings (collectively, “Proceedings”) relating to (i) the negotiation, preparation, execution or performance of this Agreement or the other Credit Documents, or any transaction contemplated herein or therein, whether or not any party protected under this Section 9.2 is a party to, or target of, any Proceeding in question (provided, however, that no indemnified party shall have the right to be indemnified hereunder for any liability resulting from the willful misconduct or gross negligence of such indemnified party (as finally determined by a court of competent jurisdiction), material breach by any Purchaser of its obligations under this Agreement, including any failure by a Purchaser to purchase the Notes as required hereunder, or disputes that are solely among Purchasers or among the Collateral Agent and the Purchasers), (ii) any breach of any of the covenants, warranties or representations of any Credit Party hereunder or under any other Credit Document, (iii) any Lien or charge upon amounts payable hereunder by any Credit Party to the Purchasers or any taxes, assessments, impositions and other charges in respect of the collateral described in the Security Documents, (iv) any violation or alleged violation of any Environmental Law, federal or state securities law, common law, equitable requirement or other legal requirement by any Credit Party or with respect to any property owned, leased or operated by any Credit Party (in the past, currently or in the future) to the extent that a Credit Party is alleged to be responsible for such violation or alleged violation, or (v) any presence, generation, treatment, storage, disposal, transport, movement, release, suspected release or threatened release of any Hazardous Material on, in, to or from any property (or any part thereof including the soil and groundwater thereon and thereunder) owned, leased or operated by any Credit Party (in the past, currently or in the future) and for which any Credit Party is alleged to be responsible.  All Costs shall be additional Obligations under this Agreement, shall be payable on demand to the party to be indemnified and shall be secured by the Lien of the Security Documents.  Without limiting the foregoing, the Borrower shall be obligated to pay, on demand, the costs of any investigation, monitoring, assessment, enforcement, removal, remediation, restoration or other response or corrective action undertaken by the Collateral Agent or the Purchasers or any other indemnified party, or their respective agents, with respect to any property owned, leased or operated by any Credit Party.  The obligations of the Borrower under this Section 9.2 shall not be limited to any extent by payment of the Obligations and termination of this Agreement and shall remain in full force and effect until expressly terminated by the Purchasers in writing.  This Section 9.2 shall not apply with respect to Taxes other than any Taxes that represent losses, claims, damages, etc. arising from any non-Tax claim.

 

9.3                                Governing Law .  This Agreement and the other Credit Documents and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Agreement or any other Credit Document (except as may be expressly otherwise provided in any Credit Document) shall be governed by, and construed in accordance with, the law of the State of New York (including Sections 5-1401 and 5-1402 of the

 

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

 

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New York General Obligations Law, but excluding all other choice of law and conflicts of law rules).

 

9.4                                Consent to Jurisdiction; Waiver of Jury Trial .  The Borrower irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind or description, whether in law or equity, whether in contract or in tort or otherwise, against any Purchaser, the Collateral Agent or any Affiliate of any of the foregoing in any way relating to this Agreement or any other Credit Document or the transactions relating hereto or thereto, in any forum other than the courts of the State of New York sitting in the City and County of New York and of the United States District Court of the Southern District of New York and any appellate court thereof, and each of the parties hereto irrevocably and unconditionally submits to the jurisdiction of such courts and agrees that all claims in respect of any such action, litigation or proceeding may be heard and determined in such state court or, to the fullest extent permitted by applicable law, in such federal court.  Each of the parties hereto agrees that a final judgment in any such action, litigation or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.  Nothing in this Agreement or in any other Credit Document shall affect any right that any Purchaser or the Collateral Agent may otherwise have to bring any action or proceeding relating to this Agreement or any other Credit Document against the Borrower or any other Credit Party or its properties in the courts of any jurisdiction.  EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER CREDIT DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).  EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PERSON HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PERSON WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE OTHER CREDIT DOCUMENTS BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.

 

9.5                                Notices .  All demands, notices, approvals, consents, requests, and other communications hereunder shall be in writing and shall be deemed to have been given when the writing is delivered, if given or delivered by hand, overnight delivery service or facsimile transmitter (with confirmed receipt), or five days after being mailed, if mailed, by first class, registered or certified mail, postage prepaid, to the address set forth below:

 

Party

 

Address

 

 

 

Borrower

 

7999 Gateway Blvd, Suite 300

 

 

Newark, California 94560

 

 

Fax: (510) 744-8001

 

 

Attention: Matt Gosling, Esq.

 

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

 

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Collateral Agent

 

c/o Deerfield Management Company, L.P.

 

 

780 Third Avenue, 37th Floor

 

 

New York, NY 10017

 

 

Fax: (212) 599-3075

 

 

Attention: Jon Isler

 

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

 

 

 

Robinson, Bradshaw & Hinson, P.A.

 

 

101 North Tryon Street, Suite 1900

 

 

Charlotte, NC 28246

 

 

Fax: (704) 373-3964

 

 

Attention: S. Graham Robinson

 

 

 

Any Purchaser

 

To the address set forth on Exhibit A for such Purchaser.

 

The Borrower or any Purchaser may, by notice given hereunder, designate any further or different addresses to which subsequent demands, notices, approvals, consents, requests or other communications shall be sent or persons to whose attention the same shall be directed.

 

9.6                                Continuing Obligations .  All agreements, representations and warranties contained herein or made in writing by or on behalf of any Credit Party in connection with the transactions contemplated hereby shall survive the execution and delivery of the Credit Documents.  The Borrower further agrees that to the extent any Credit Party makes a payment to the Collateral Agent or the Purchasers, which payment or any part thereof is subsequently invalidated, declared to be fraudulent or preferential, set aside or required to be repaid to a trustee, receiver or any other party under any bankruptcy, insolvency or other similar state or federal statute, or principle of equity, then, to the extent of such repayment by the Collateral Agent or the Purchasers, the Obligation or part thereof intended to be satisfied by such payment shall be revived and continued in full force and effect as if such payment had not been received by the Collateral Agent or the Purchasers.

 

9.7                                Successors and Assigns .  This Agreement shall be binding upon the Borrower and its respective successors and assigns and all rights against the Borrower arising under this Agreement shall be for the sole benefit of the Collateral Agent and the Purchasers.

 

9.8                                Assignment and Sale .  The Borrower may not sell, assign or transfer this Agreement or any of the other Credit Documents or any portion hereof or thereof, including their respective rights, title, interests, remedies, powers, and duties hereunder or thereunder.  Nothing in any Credit Document shall prohibit the Purchasers from pledging or assigning this Agreement, the Notes and the Purchasers’ rights under any of the Credit Documents, including collateral therefor, or any portion hereof or thereof to any Person other than a Restricted Transferee; provided that, in the case of an assignment of the Notes or any rights or participations therein, such Person shall agree in writing to the provisions hereof applicable to Purchasers (including without limitation, the provisions of Article 8 and Sections 9.10 and 9.11) .  Any assignee or

 

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

 

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successor to a Purchaser shall become a “Purchaser” under this Agreement at the time such Person’s ownership interest in a Note is recorded in the Register and such Person shall be subject to the obligations set forth in this Agreement.

 

9.9                                Entire Agreement THIS AGREEMENT AND THE DOCUMENTS AND INSTRUMENTS EXECUTED AND DELIVERED CONTEMPORANEOUSLY HEREWITH EMBODY THE ENTIRE AGREEMENT AND UNDERSTANDING BETWEEN THE PARTIES HERETO AND SUPERSEDE ALL PRIOR AGREEMENTS AND UNDERSTANDINGS OF SUCH PERSONS, VERBAL OR WRITTEN, RELATING TO THE SUBJECT MATTER HEREOF.  THIS AGREEMENT AND THE DOCUMENTS AND INSTRUMENTS EXECUTED IN CONNECTION HEREWITH REPRESENT THE FINAL AGREEMENT BETWEEN THE PARTIES AND MAY NOT BE CONTRADICTED BY PRIOR, CONTEMPORANEOUS OR SUBSEQUENT ORAL AGREEMENTS OF THE PARTIES.  THERE ARE NO UNWRITTEN ORAL AGREEMENTS BETWEEN THE PARTIES.

 

9.10                         Amendment .  No amendment, modification, waiver or discharge or termination of, or consent to any departure by any Credit Party from, any provision of this Agreement or any other Credit Document shall be effective unless in a writing signed by the Required Purchasers, and then the same shall be effective only in the specific instance and for the specific purpose for which given; provided , however , that no such amendment, modification, waiver, discharge, termination or consent shall:

 

(a)                                  unless agreed to by each Purchaser directly affected thereby, (i) reduce or forgive the principal amount of any Note, reduce the rate of or forgive any interest thereon, or reduce or forgive any premium or fees hereunder, (ii) extend the final scheduled maturity date or any other scheduled date for the payment of any principal of or interest on any Note, or extend the time of payment of any premium or fees hereunder, (iii) increase any Commitment of any such Purchaser over the amount thereof in effect or extend the maturity thereof (it being understood that a waiver of any condition precedent set forth in Sections 3.1 or 3.2 or of any Default or Event of Default or mandatory reduction in the Commitments, if agreed to by the Required Purchasers or all Purchasers (as may be required hereunder with respect to such waiver), shall not constitute such an increase), (iv) reduce the percentage of the aggregate Commitments or of the aggregate outstanding principal amount of the Notes, or the number or percentage of Purchasers, that shall be required for the Purchasers or any of them to take or approve, or direct the Collateral Agent to take, any action hereunder or under any other Credit Document (including as set forth in the definition of “Required Purchasers”), (v) change any other provision of this Agreement or any of the other Credit Documents requiring, by its terms, the consent or approval of all the Purchasers for such amendment, modification, waiver, discharge, termination or consent, (vi) change or waive any provision of Section 2.13 , any other provision of this Agreement or any other Credit Document requiring pro rata treatment of any Purchasers, or this Section 9.10 , or (vii) release any lien on all or substantially all of the collateral pledged by the Credit Parties under the Security Documents other than in connection with a sale or transfer of assets permitted by this Agreement; and

 

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

 

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(b)                                  unless agreed to by the Collateral Agent in addition to the Purchasers required as provided hereinabove to take such action, affect the respective rights or obligations of the Collateral Agent, as applicable, hereunder or under any of the other Credit Documents.

 

9.11                         Treatment of Certain Information; Confidentiality .  Each of the Collateral Agents and the Purchasers agrees to maintain the confidentiality of the Information (as defined below), except that Information may be disclosed (a) to its Affiliates and to its and its Affiliates’ respective partners, directors, officers, employees, agents, advisors, managing members or managers, counsel, accountants and other representatives (collectively, “ Representatives ”) (it being understood that the Persons to whom such disclosure is made will be informed of the confidential nature of such Information and instructed to keep such Information confidential and the person making such disclosure shall remain liable and be responsible for any breach by such Representative of the provisions of this Section 9.11 ), (b) to the extent requested by any Governmental Authority or regulatory authority (including any self-regulatory authority, such as the National Association of Insurance Commissioners) (in which case, the Collateral Agent or such Purchaser, as applicable, shall use reasonable efforts to notify the Borrower prior to such disclosure to the extent practicable and legally permitted to do so), (c) to the extent required by applicable Requirements of Laws or by any subpoena or similar legal process, (d) to any other party hereto, (e) in connection with the exercise of any remedies hereunder or under any other Credit Document or any action or proceeding relating to this Agreement or any other Credit Document or the enforcement of rights hereunder or thereunder, (f) to any state, federal or foreign authority or examiner regulating any Purchaser, (g) subject to an agreement containing provisions substantially the same as those of this Section 9.11 , to any actual or prospective permitted assignee of the Purchaser (or their Representatives, it being understood that the Persons to whom such disclosure is made will be informed of the confidential nature of such Information and instructed to keep such Information confidential), (h) with the consent of the Borrower, or (i) to the extent such Information becomes available to the Collateral Agent, any Purchaser or any of their respective Affiliates on a non-confidential basis from a source other than a Consolidated Entity; provided that, to the knowledge of the recipient of such Information, the source of such Information was not and is not bound by any contractual or other obligation of confidentiality to the Borrower or any other Person with respect to any of such information. For purposes of this Section 9.11 , “ Information ” means all information received from any Consolidated Entity relating to any Consolidated Entity or any of their respective businesses excluding any such information that is generally available to the public, other than as a direct or indirect result of the disclosure of any of such information by the Collateral Agent, any Purchaser or any of their Representatives.

 

9.12                         Representations and Warranties of the Purchasers . Each Purchaser, severally and not jointly, represents and warrants to the Borrower as of the date hereof and as of each date that any Notes are issued to such Purchaser, that:

 

(a)                                  Such Purchaser is duly organized and validly existing under the laws of the jurisdiction of its formation. Each Credit Document to which it is a party has been duly authorized, executed and delivered by such Purchaser and constitutes the valid and legally binding obligation of such Purchaser, enforceable against such Purchaser in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization,

 

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

 

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moratorium or other similar laws, statutes or rules of general application affecting the enforcement of creditor’s rights or general principles of equity.

 

(b)                                  Each of the Notes to be received by such Purchaser hereunder will be acquired for such Purchaser’s own account, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, except pursuant to sales registered or exempted under the Securities Act, and such Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to such Purchaser’s right at all times to sell or otherwise dispose of all or any part of such Notes in compliance with applicable federal and state securities laws.

 

(c)                                   Such Purchaser can bear the economic risk and complete loss of its investment in the Notes and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby.

 

(d)                                  Such Purchaser has had an opportunity to receive, review and understand all information related to the Borrower requested by it and to ask questions of and receive answers from the Borrower regarding the Borrower, its business and the terms and conditions of the offering of the Notes, and has conducted and completed its own independent due diligence. Such Purchaser acknowledges receipt of copies of the Borrower’s filings with the SEC. Based on the information such Purchaser has deemed appropriate, it has independently made its own analysis and decision to enter into the Credit Documents.

 

(e)                                   Such Purchaser understands that the Notes are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Borrower in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances.  Such Purchaser understands that no United States federal or state agency, or similar agency of any other country, has reviewed, approved, passed upon, or made any recommendation or endorsement of the Borrower or the purchase of the Notes.

 

(f)                                    Such Purchaser is an “accredited investor” in Regulation D promulgated under the 1933 Act.

 

(g)                                   Such Purchaser did not learn of the investment in the Loan Securities as a result of any general solicitation or general advertising.

 

9.13                         Severability .  In the event that any provision of this Agreement shall be determined to be invalid or unenforceable by any court of competent jurisdiction, such determination shall not invalidate or render unenforceable any other provision hereof.

 

9.14                         Counterparts .  This Agreement may be executed in several counterparts, each of which shall be an original and all of which, together shall constitute but one and the same instrument.  Delivery of an executed counterpart of a signature page of this Agreement by facsimile or in electronic format (e.g., “pdf,” “tif” or similar file formats) shall be effective as delivery of a manually executed counterpart of this Agreement.

 

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

 

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9.15                         Captions .  The captions to the various sections and subsections of this Agreement have been inserted for convenience only and shall not limit or affect any of the terms hereof.

 

[The remainder of this page is left blank intentionally.]

 

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

 

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

 

 

DEPOMED, INC. , as the Borrower

 

 

 

 

 

By:

/s/ August J. Moretti

 

Name:

August J. Moretti

 

Title:

Sr. Vice President & Chief Financial Officer

 

 

 

 

 

BIOPHARMA SECURED INVESTMENTS III HOLDINGS CAYMAN LP,

 

as a Purchaser

 

 

 

By:

Pharmakon Advisors, LP,

 

 

its Investment Manager

 

 

 

By:

Pharmakon Management I, LLC,

 

 

its General Partner

 

 

 

 

 

By:

/s/ Pedro Gonzalez de Cosio

 

Name:

Pedro Gonzalez de Cosio

 

Title:

Managing Member

 

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

 

Signature Page to Note Purchase Agreement

 



 

 

DEERFIELD PRIVATE DESIGN FUND III, L.P. , as Collateral Agent and a Purchaser

 

 

 

By:

Deerfield Mgmt III, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital III, LLC

 

 

 

General Partner

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

 

 

 

 

DEERFIELD PARTNERS, L.P. , as a Purchaser

 

 

 

By:

Deerfield Mgmt, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital, LLC

 

 

 

General Partner

 

 

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

 

 

DEERFIELD INTERNATIONAL MASTER FUND, L.P. , as a Purchaser

 

 

 

By:

Deerfield Mgmt, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital, LLC

 

 

 

General Partner

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

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

 

Signature Page to Note Purchase Agreement

 



 

 

DEERFIELD SPECIAL SITUATIONS FUND, L.P. , as a Purchaser

 

 

 

By:

Deerfield Mgmt, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital, LLC

 

 

 

General Partner

 

 

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

 

 

 

 

DEERFIELD PRIVATE DESIGN FUND II, L.P. , as a Purchaser

 

 

 

By:

Deerfield Mgmt, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital, LLC

 

 

 

General Partner

 

 

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

 

 

 

 

DEERFIELD PRIVATE DESIGN INTERNATIONAL II, L.P. , as a Purchaser

 

 

 

By:

Deerfield Mgmt, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital, LLC

 

 

 

General Partner

 

 

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

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

 

Signature Page to Note Purchase Agreement

 



 

EXHIBIT A

 

COMMITMENTS; NOTICE ADDRESSES

 

Purchaser

 

Commitment

 

Notice Address

Deerfield Private Design Fund III, L.P.

 

$

165,000,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

Deerfield Partners, L.P.

 

$

60,345,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

Deerfield International Master Fund, L.P.

 

$

74,655,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

Deerfield Special Situations Fund, L.P.

 

$

15,000,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

Deerfield Private Design Fund II, L.P.

 

$

27,960,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

Deerfield Private Design International II, L.P.

 

$

32,040,000

 

c/o Deerfield Management Company, L.P.

780 Third Avenue, 37th Floor

New York, NY 10017

Fax: (212) 599-3075

Attention: Jon Isler

BioPharma Secured Investments III Holdings Cayman LP

 

$

200,000,000

 

c/o Intertrust Corporate Services (Cayman) Limited

190 Elgin Avenue

Georgetown, Grand Cayman KY1-9005

Grand Cayman

Attention: Pedro Gonzalez de Cosio

Facsimile: (345) 945-4757

 

with copies (which shall not constitute notice) to:

 

Pharmakon Advisors LP

110 East 59th Street, #3300

New York, NY 10022

 

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

 



 

 

 

 

 

Attn: Pedro Gonzalez de Cosio

Phone: (212) 883-2296

Fax: (917) 210-4048

Email: [***]

 

and

 

Akin Gump Strauss Hauer & Feld LLP

One Bryant Park

New York, NY 10036-6745

Attn: Geoffrey E. Secol, Esq.

Phone: (212) 872-8081

Fax: (212) 872-1002

Email: gsecol@akingump.com

 

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

 



 

EXHIBIT B

 

FORM OF NOTE

 

(See attached.)

 

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

 



 

FORM OF SENIOR SECURED NOTE

 

$[ · ]

[ · ], 2015

 

FOR VALUE RECEIVED , DEPOMED, INC. , a California corporation (the “ Borrower ”), hereby promises to pay to [ · ] , a [ · ] (the “ Purchaser ”), at its offices located at [ · ] (or at such other place or places as the Purchaser may designate), at the times and in the manner provided in the Note Purchase Agreement, dated as of March 12, 2015 (as amended, modified, restated or supplemented from time to time, the “ Note Purchase Agreement ”), among the Borrower, the Purchasers from time to time parties thereto, and Deerfield Private Design Fund III, L.P., a Delaware limited partnership, as Collateral Agent and a Purchaser, the principal sum of [ · ] ($ [ · ] .00), under the terms and conditions of this senior secured note (this “ Note ”) and the Note Purchase Agreement.  The defined terms in the Note Purchase Agreement are used herein with the same meaning.  The Borrower also promises to pay interest on the aggregate unpaid principal amount of this Note at the rates applicable thereto from time to time as provided in the Note Purchase Agreement.

 

This Note is one of the Notes referred to in the Note Purchase Agreement and is issued to evidence the Loan made by the Purchaser pursuant to the Note Purchase Agreement.  All of the terms, conditions and covenants of the Note Purchase Agreement are expressly made a part of this Note by reference in the same manner and with the same effect as if set forth herein at length, and any holder of this Note is entitled to the benefits of and remedies provided in the Note Purchase Agreement and the other Credit Documents.  Reference is made to the Note Purchase Agreement for provisions relating to the interest rate, maturity, payment, prepayment and acceleration of this Note.

 

In the event of an acceleration of the maturity of this Note pursuant to the Note Purchase Agreement, this Note shall become immediately due and payable, without presentation, demand, protest or notice of any kind, all of which are hereby waived by the Borrower.

 

In the event this Note is not paid when due at any stated or accelerated maturity, the Borrower agrees to pay, in addition to the principal and interest, all costs of collection, including reasonable attorneys’ fees.

 

This Note and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Note shall be governed by, and construed in accordance with, the law of the State of New York.  The Borrower hereby submits to the nonexclusive jurisdiction and venue of the courts of the State of New York sitting in the City and County of New York and of the United States District Court of the Southern District of New York, and any appellate court from any thereof, although the Purchaser shall not be limited to bringing an action in such courts.

 

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

 



 

THIS NOTE IS ISSUED WITH ORIGINAL ISSUE DISCOUNT (“OID”) FOR U.S. FEDERAL INCOME TAX PURPOSES. THE ISSUE PRICE, AMOUNT OF OID, ISSUE DATE AND YIELD TO MATURITY WITH RESPECT TO THIS NOTE MAY BE OBTAINED BY WRITING TO THE BORROWER AT THE FOLLOWING ADDRESS: 7999 GATEWAY BLVD., SUITE 300, NEWARK, CALIFORNIA 94560, ATTENTION: CONTROLLER, FAX NUMBER: (510) 744-8001.

 

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

 

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

 



 

IN WITNESS WHEREOF , the Borrower has caused this Note to be executed by its duly authorized corporate officer as of the day and year first above written.

 

 

 

DEPOMED, INC.

 

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

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

 



 

EXHIBIT C

 

FORM OF PURCHASE NOTICE

 

(See attached.)

 

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

 



 

FORM OF

PURCHASE NOTICE

 

[ · ], 2015

 

[Insert Name and Address

Of Purchasers]

 

Ladies and Gentlemen:

 

The undersigned, Depomed, Inc. (the “Borrower”), refers to the Note Purchase Agreement, dated as of March 12, 2015, among the Borrower, the Collateral Agent, and certain Purchasers party thereto (as amended, modified, restated or supplemented from time to time, the “Note Purchase Agreement,” the terms defined therein being used herein as therein defined). Pursuant to Section 2.1(b) of the Note Purchase Agreement, the Borrower hereby gives you irrevocable notice that the Borrower desires to issue and sell to each Purchaser, and requests that each Purchaser purchase, a Note with an original principal amount equal to such Purchaser’s Commitment subject to and on the terms and conditions set forth in the Note Purchase Agreement, and to that end sets forth below the information relating to such requested sale and purchase as required by Section 2.1(b) of the Investment Agreement:

 

(i)                                      The date of sale and purchase of the Notes is requested to be              , 2015 (the “Purchase Date”).

 

(ii)                                   (The Borrower directs each Purchaser to wire the Note purchase proceeds to and on behalf of the Borrower in accordance with the payment and wiring instructions attached hereto as Schedule A .

 

The Borrower acknowledges that the Purchasers’ obligations to purchase the Notes shall be subject to the satisfaction of the conditions set forth in Section 3.2 to the Note Purchase Agreement.

 

[ The remainder of this page is left blank intentionally. ]

 

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

 



 

 

Very truly yours,

 

 

 

DEPOMED, INC.

 

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

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

 



 

SCHEDULE A

 

PAYMENT AND WIRE INSTRUCTIONS

 

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

 



 

EXHIBIT D-1

 

U.S. TAX COMPLIANCE CERTIFICATE

(For Foreign Purchasers That Are Not Partnerships For U.S. Federal Income Tax Purposes)

 

Reference is hereby made to the Note Purchase Agreement dated as of March 12, 2015 (as amended, supplemented or otherwise modified from time to time, the “Note Purchase Agreement ”), among Depomed, Inc., as Borrower, Deerfield Private Design Fund III., L.P., as Collateral Agent, and each purchaser from time to time party thereto.

 

Pursuant to the provisions of Section 2.11 of the Credit Agreement, the undersigned hereby certifies that (i) it is the sole record and beneficial owner of the Note(s) in respect of which it is providing this certificate, (ii) it is not a bank within the meaning of Section 881(c)(3)(A) of the Code, (iii) it is not a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (iv) it is not a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.

 

Unless otherwise defined herein, terms defined in the Note Purchase Agreement and used herein shall have the meanings given to them in the Note Purchase Agreement.

 

 

[NAME OF PURCHASER]

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

Date:                      , 20[  ]

 

 

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

 



 

EXHIBIT D-2

 

U.S. TAX COMPLIANCE CERTIFICATE

(For Foreign Purchasers That Are Partnerships For U.S. Federal Income Tax Purposes)

 

Reference is hereby made to the Note Purchase Agreement dated as of March 12, 2015 (as amended, supplemented or otherwise modified from time to time, the “ Note Purchase Agreement ”), among Depomed, Inc., as Borrower, Deerfield Private Design Fund III., L.P., as Collateral Agent, and each purchaser from time to time party thereto.

 

Pursuant to the provisions of Section 2.11 of the Note Purchase Agreement, the undersigned hereby certifies that (i) it is the sole record owner of the Note(s) in respect of which it is providing this certificate, (ii) with respect to the extension of credit pursuant to this Note Purchase Agreement or any other Credit Document, neither the undersigned nor any of its beneficial owners is a bank extending credit pursuant to a loan agreement entered into in the ordinary course of its trade or business within the meaning of Section 881(c)(3)(A) of the Code, (iii) none of its beneficial owners is a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (iv) none of its beneficial owners is a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.

 

Unless otherwise defined herein, terms defined in the Note Purchase Agreement and used herein shall have the meanings given to them in the Note Purchase Agreement.

 

[NAME OF PURCHASER]

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

Date:                      , 20[  ]

 

 

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

 



 

EXHIBIT E

 

FORM OF GUARANTY

 

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

 



 

GUARANTY AGREEMENT

 

THIS GUARANTY AGREEMENT , dated as of the [ · ] day of [ · ], 2015 (this “ Guaranty ”), is made by [ [Acquisition Subsidiary] , a [ · ] (“ Acquisition Sub ”)](1) and Subsidiary of DEPOMED, INC. , a California corporation (the “ Borrower ”), and each Subsidiary of the Borrower that, after the date hereof, executes an instrument of accession hereto substantially in the form of Exhibit A (a “ Guarantor Accession ”; such Subsidiaries of the Borrower, including Acquisition Sub, the “ Guarantors ”), in favor of the Guaranteed Parties (as hereinafter defined).  Capitalized terms used herein without definition shall have the meanings given to them in the Note Purchase Agreement referred to below.

 

RECITALS

 

A.                                     The Borrower, the Purchasers party thereto, and Deerfield Private Design Fund III, L.P., as a Purchaser and as Collateral Agent for the Purchasers (in such capacity, the “ Collateral Agent ”), are parties to a Note Purchase Agreement, dated as of March 12, 2015 (as amended, modified, restated or supplemented from time to time, the “ Note Purchase Agreement ”), pursuant to which the Purchasers [will purchase](2) [purchased](3) the Notes upon the terms and subject to the conditions set forth therein.

 

B.                                     [It is a condition to the purchase of the Notes by the Purchasers under the Note Purchase Agreement that each Guarantor shall have agreed, by executing and delivering this Guaranty, to guarantee to the Guaranteed Parties the payment in full of the Guaranteed Obligations (as hereinafter defined).  The Guaranteed Parties are relying on this Guaranty in their decision to purchase the Notes from the Borrower under the Note Purchase Agreement, and would not purchase the Notes thereunder without this Guaranty.](4)

 

C.                                     The Borrower and the Guarantors are engaged in related businesses and undertake certain activities and operations on an integrated basis.  As part of such integrated operations, the Borrower, among other things, will advance to the Guarantors from time to time certain proceeds from the sale of the Notes by the Borrower to the Purchasers pursuant to the Note Purchase Agreement.  Each Guarantor will therefore obtain benefits as a result of the sale of the Notes by the Borrower under the Note Purchase Agreement, which benefits are hereby acknowledged, and, accordingly, desires to execute and deliver this Guaranty.

 


(1)  NTD - Acquisition Subsidiary only applies to the extent formed prior to close.

(2)  NTD - Include if there is an Acquisition Subsidiary formed prior to close.

(3)  NTD - Include if no Acquisition Subsidiary is formed prior to close.

(4)  NTD - Include if there is an Acquisition Subsidiary formed prior to close.

 

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

 



 

STATEMENT OF AGREEMENT

 

NOW, THEREFORE , in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, to induce the Guaranteed Parties to enter into the Note Purchase Agreement and to induce the Purchasers to purchase the Notes from the Borrower thereunder, each Guarantor hereby agrees as follows:

 

1.                                       Guaranty .

 

(a)                                  Each Guarantor hereby irrevocably, absolutely and unconditionally, and jointly and severally:

 

(i)                                      guarantees to the Purchasers and the Collateral Agent (collectively, the “ Guaranteed Parties ”) the full and prompt payment, at any time and from time to time as and when due (whether at the stated maturity, by acceleration or otherwise), of all of the Obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents, including all principal of and interest on the Notes, all fees, expenses, indemnities and other amounts payable by the Borrower under the Note Purchase Agreement or any other Credit Document (including interest accruing after the filing of a petition or commencement of a case by or with respect to the Borrower seeking relief under any Insolvency Laws (as hereinafter defined), whether or not the claim for such interest is allowed in such proceeding), and all Obligations that, but for the operation of the automatic stay under Section 362(a) of the Bankruptcy Code, would become due, whether now existing or hereafter created or arising and whether direct or indirect, absolute or contingent, due or to become due (all liabilities and obligations described in this Section 1(a)(i) , collectively, the “ Guaranteed Obligations ”);

 

(ii)                                   agrees to pay on demand all reasonable and documented out-of-pocket expenses of the Guaranteed Parties hereunder, including reasonable fees and disbursements of counsel in connection with (A) any amendments, supplements, consents or waivers hereto and (B) the administration or enforcement of this Guaranty; and

 

(iii)                                agrees to indemnify, defend and hold harmless each Guaranteed Party and their respective Related Parties from and against all damages, losses and other out-of-pocket costs and expenses of any kind or nature whatsoever pursuant to the terms of Section 9.2 of the Note Purchase Agreement.

 

(b)                                  Notwithstanding the provisions of Section 1(a)  and notwithstanding any other provisions contained herein or in any other Credit Document:

 

(i)                                      no provision of this Guaranty shall require or permit the collection from any Guarantor of interest in excess of the maximum rate or amount that such Guarantor may be required or permitted to pay pursuant to applicable law; and

 

(ii)                                   the liability of each Guarantor under this Guaranty as of any date shall be limited to a maximum aggregate amount (the “ Maximum Guaranteed Amount ”) equal to the greatest amount that would not render such Guarantor’s obligations under this Guaranty subject to avoidance, discharge or reduction as of such date as a fraudulent

 

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

 



 

transfer or conveyance under applicable federal and state laws pertaining to bankruptcy, reorganization, arrangement, moratorium, readjustment of debts, dissolution, liquidation or other debtor relief, specifically including the Bankruptcy Code and any fraudulent transfer and fraudulent conveyance laws (collectively, “ Insolvency Laws ”), in each instance after giving effect to all other liabilities of such Guarantor, contingent or otherwise, that are relevant under applicable Insolvency Laws (specifically excluding, however, any liabilities of such Guarantor in respect of intercompany indebtedness to the Borrower or any of its Affiliates to the extent that such indebtedness would be discharged in an amount equal to the amount paid by such Guarantor hereunder, and after giving effect as assets to the value (as determined under applicable Insolvency Laws) of any rights to subrogation, contribution, reimbursement, indemnity or similar rights of such Guarantor pursuant to (x) applicable law or (y) any agreement (including this Guaranty) providing for an equitable allocation among such Guarantor and other Affiliates of the Borrower of obligations arising under guaranties by such parties).

 

(c)                                   The Guarantors desire to allocate among themselves, in a fair and equitable manner, their obligations arising under this Guaranty.  Accordingly, in the event any payment or distribution is made hereunder on any date by a Guarantor (a “ Funding Guarantor ”) that exceeds its Fair Share (as hereinafter defined) as of such date, that Funding Guarantor shall be entitled to a contribution from each of the other Guarantors in the amount of such other Guarantor’s Fair Share Shortfall (as hereinafter defined) as of such date, with the result that all such contributions will cause each Guarantor’s Aggregate Payments (as hereinafter defined) to equal its Fair Share as of such date.

 

Fair Share ” means, with respect to a Guarantor as of any date of determination, an amount equal to (i) the ratio of (x) the Adjusted Maximum Guaranteed Amount (as hereinafter defined) with respect to such Guarantor to (y) the aggregate of the Adjusted Maximum Guaranteed Amounts with respect to all Guarantors, multiplied by (ii) the aggregate amount paid or distributed on or before such date by all Funding Guarantors hereunder in respect of the obligations guarantied.

 

Fair Share Shortfall ” means, with respect to a Guarantor as of any date of determination, the excess, if any, of the Fair Share of such Guarantor over the Aggregate Payments of such Guarantor.

 

Adjusted Maximum Guaranteed Amount ” means, with respect to a Guarantor as of any date of determination, the Maximum Guaranteed Amount of such Guarantor determined without considering any assets or liabilities arising by virtue of any rights to subrogation, reimbursement or indemnity or any rights to or obligations of contribution hereunder as assets or liabilities of such Guarantor.

 

Aggregate Payments ” means, with respect to a Guarantor as of any date of determination, the aggregate amount of all payments and distributions made on or before such date by such Guarantor in respect of this Guaranty (including in respect of this Section 1(c) ).

 

The amounts payable as contributions hereunder shall be determined as of the date on which the related payment or distribution is made by the applicable Funding Guarantor.  Each

 

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

 



 

Funding Guarantor’s right of contribution under this Section 1(c)  shall be subject to the provisions of Section 4 .  The allocation among Guarantors of their obligations as set forth in this Section 1(c)  shall not be construed in any way to limit the liability of any Guarantor hereunder to the Guaranteed Parties.

 

(d)                                  The guaranty of each Guarantor set forth in this Section 1 is a guaranty of payment as a primary obligor, and not a guaranty of collection.  Each Guarantor hereby acknowledges and agrees that the Guaranteed Obligations, at any time and from time to time, may exceed the Maximum Guaranteed Amount of such Guarantor and may exceed the aggregate of the Maximum Guaranteed Amounts of all Guarantors, in each case without discharging, limiting or otherwise affecting the obligations of any Guarantor hereunder or the rights, powers and remedies of any Guaranteed Party hereunder or under any other Credit Document.

 

2.                                       Guaranty Absolute .  Each Guarantor agrees that its obligations hereunder and under the other Credit Documents to which it is a party are irrevocable, absolute and unconditional, are independent of the Guaranteed Obligations and any Collateral (as defined in the Security Agreement) or other security therefor or other guaranty or liability in respect thereof, whether given by such Guarantor or any other Person, and shall not be discharged, limited or otherwise affected by reason of any of the following, whether or not such Guarantor has notice or knowledge thereof:

 

(i)                                      any change in the time, manner or place of payment of, or in any other term of, any Guaranteed Obligations or any guaranty or other liability in respect thereof, or any amendment, modification or supplement to, restatement of, or consent to any rescission or waiver of or departure from, any provisions of the Note Purchase Agreement, any other Credit Document or any agreement or instrument delivered pursuant to any of the foregoing;

 

(ii)                                   the invalidity or unenforceability of any Guaranteed Obligations, any guaranty or other liability in respect thereof or any provisions of the Note Purchase Agreement, any other Credit Document or any agreement or instrument delivered pursuant to any of the foregoing;

 

(iii)                                the addition or release of Guarantors hereunder or the taking, acceptance or release of other guarantees of any Guaranteed Obligations or additional Collateral or other security for any Guaranteed Obligations or for any guaranty or other liability in respect thereof;

 

(iv)                               any discharge, modification, settlement, compromise or other action in respect of any Guaranteed Obligations or any guaranty or other liability in respect thereof, including any acceptance or refusal of any offer or performance with respect to the same or the subordination of the same to the payment of any other obligations;

 

(v)                                  any agreement not to pursue or enforce or any failure to pursue or enforce (whether voluntarily or involuntarily, as a result of operation of law, court order or otherwise) any right or remedy in respect of any Guaranteed Obligations, any guaranty or other liability in respect thereof or any Collateral or other security for any of the foregoing; any sale, exchange, release, substitution, compromise or other action in

 

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

 



 

respect of any such Collateral or other security; or any failure to create, protect, perfect, secure, insure, continue or maintain any Liens in any such Collateral or other security;

 

(vi)                               the exercise of any right or remedy available under the Credit Documents, at law, in equity or otherwise in respect of any Collateral or other security for any Guaranteed Obligations or for any guaranty or other liability in respect thereof, in any order and by any manner thereby permitted, including foreclosure on any such Collateral or other security by any manner of sale thereby permitted, whether or not every aspect of such sale is commercially reasonable;

 

(vii)                            any bankruptcy, reorganization, arrangement, liquidation, insolvency, dissolution, termination, reorganization or like change in the corporate structure or existence of the Borrower or any other Person directly or indirectly liable for any Guaranteed Obligations;

 

(viii)                         any manner of application of any payments by or amounts received or collected from any Person, by whomsoever paid and howsoever realized, whether in reduction of any Guaranteed Obligations or any other obligations of the Borrower or any other Person directly or indirectly liable for any Guaranteed Obligations, regardless of what Guaranteed Obligations may remain unpaid after any such application; or

 

(ix)                               any other circumstance that might otherwise constitute a legal or equitable discharge of, or a defense, setoff or counterclaim available to, the Borrower, any Guarantor or a surety or guarantor generally, other than the occurrence of all of the following:  (x) the payment in full in cash of the Guaranteed Obligations (other than contingent and indemnification obligations not then due and payable) and (y) the termination of the Commitments under the Note Purchase Agreement (the events in clauses (x) and (y) above, collectively, the “ Termination Requirements ”).

 

3.                                       Certain Waivers .  Each Guarantor hereby knowingly, voluntarily and expressly waives:

 

(i)                                      presentment, demand for payment, demand for performance, protest and notice of any other kind, including notice of nonpayment or other nonperformance (including notice of default under any Credit Document with respect to any Guaranteed Obligations), protest, dishonor, acceptance hereof, extension of additional credit to the Borrower and of any of the matters referred to in Section 2 and of any rights to consent thereto;

 

(ii)                                   any right to require the Guaranteed Parties or any of them, as a condition of payment or performance by such Guarantor hereunder, to proceed against, or to exhaust or have resort to any Collateral or other security from or any deposit balance or other credit in favor of, the Borrower, any other Guarantor or any other Person directly or indirectly liable for any Guaranteed Obligations, or to pursue any other remedy or enforce any other right; and any other defense based on an election of remedies with respect to any Collateral or other security for any Guaranteed Obligations or for any guaranty or other liability in respect thereof, notwithstanding that any such election (including any failure to pursue or enforce any rights or remedies) may impair or

 

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

 



 

extinguish any right of indemnification, contribution, reimbursement or subrogation or other right or remedy of any Guarantor against the Borrower, any other Guarantor or any other Person directly or indirectly liable for any Guaranteed Obligations or any such Collateral or other security;

 

(iii)                                any right or defense based on or arising by reason of any right or defense of the Borrower or any other Person, including any defense based on or arising from a lack of authority or other disability of the Borrower or any other Person, the invalidity or unenforceability of any Guaranteed Obligations, any Collateral or other security therefor or any Credit Document or other agreement or instrument delivered pursuant thereto, or the cessation of the liability of the Borrower for any reason other than the satisfaction of the Termination Requirements;

 

(iv)                               any defense based on any Guaranteed Party’s acts or omissions in the administration of the Guaranteed Obligations, any guaranty or other liability in respect thereof or any Collateral or other security for any of the foregoing, and promptness, diligence or any requirement that any Guaranteed Party create, protect, perfect, secure, insure, continue or maintain any Liens in any such Collateral or other security;

 

(v)                                  any right to assert against any Guaranteed Party, as a defense, counterclaim, crossclaim or setoff, any defense, counterclaim, claim, right of recoupment or setoff that it may at any time have against any Guaranteed Party (including failure of consideration, fraud, fraudulent inducement, statute of limitations, payment, accord and satisfaction and usury), other than compulsory counterclaims and other than the payment in full in cash of the Guaranteed Obligations; and

 

(vi)                               any defense based on or afforded by any applicable law that limits the liability of or exonerates guarantors or sureties or that may in any other way conflict with the terms of this Guaranty.

 

4.                                       No Subrogation; Subordination .  Each Guarantor hereby waives, and agrees that it will not exercise or seek to exercise, any claim or right that it may have against the Borrower or any other Guarantor at any time as a result of any payment made under or in connection with this Guaranty or the performance or enforcement hereof, including any right of subrogation to the rights of any of the Guaranteed Parties against the Borrower or any other Guarantor, any right of indemnity, contribution or reimbursement against the Borrower or any other Guarantor (including rights of contribution as set forth in Section 1(c) ), any right to enforce any remedies of any Guaranteed Party against the Borrower or any other Guarantor, or any benefit of, or any right to participate in, any Collateral or other security held by any Guaranteed Party to secure payment of the Guaranteed Obligations, in each case whether such claims or rights arise by contract, statute (including the Bankruptcy Code), common law or otherwise; provided , however , that a Guarantor may enforce the rights of contribution set forth in Section 1(c)  after satisfaction of the Termination Requirements.  Each Guarantor further agrees that all indebtedness and other obligations, whether now or hereafter existing, of the Borrower or any other Subsidiary of the Borrower to such Guarantor, including any such indebtedness in any proceeding under the Bankruptcy Code and any intercompany debt or receivables, together with any interest thereon, shall be, and hereby are, subordinated and made junior in right of payment to the Guaranteed

 

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Obligations.  Each Guarantor further agrees that if any amount shall be paid to or any distribution received by any Guarantor (i) on account of any such indebtedness at any time after the occurrence and during the continuance of an Event of Default, or (ii) on account of any rights of contribution at any time prior to the satisfaction of the Termination Requirements, such amount or distribution shall be deemed to have been received and to be held in trust for the benefit of the Guaranteed Parties, and shall forthwith be delivered to the Collateral Agent in the form received (with any necessary endorsements in the case of written instruments), to be applied against the Guaranteed Obligations, whether or not matured, in accordance with the terms of the applicable Credit Documents and without in any way discharging, limiting or otherwise affecting the liability of such Guarantor under any other provision of this Guaranty.  Additionally, in the event the Borrower or any other Credit Party becomes a “debtor” within the meaning of the Bankruptcy Code, the Collateral Agent shall be entitled, at its option, on behalf of the Guaranteed Parties and as attorney-in-fact for each Guarantor, and is hereby authorized and appointed by each Guarantor, to file proofs of claim on behalf of each relevant Guarantor and vote the rights of each such Guarantor in any plan of reorganization, and to demand, sue for, collect and receive every payment and distribution on any indebtedness of the Borrower or such Credit Party to any Guarantor in any such proceeding, each Guarantor hereby assigning to the Collateral Agent all of its rights in respect of any such claim, including the right to receive payments and distributions in respect thereof.

 

5.                                       Representations and Warranties .  Each Guarantor hereby represents and warrants to the Guaranteed Parties that, as to itself, all of the representations and warranties set forth in Sections 4.1, 4.2, 4.3, 4.4, 4.5 and 4.7 relating to it contained in the Note Purchase Agreement are true and correct.

 

6.                                       Financial Condition of Borrower .  Each Guarantor represents that it has knowledge of the Borrower’s financial condition and affairs and that it has adequate means to obtain from the Borrower on an ongoing basis information relating thereto and to the Borrower’s ability to pay and perform the Guaranteed Obligations, and agrees to assume the responsibility for keeping, and to keep, so informed for so long as this Guaranty is in effect with respect to such Guarantor.  Each Guarantor agrees that the Guaranteed Parties shall have no obligation to investigate the financial condition or affairs of the Borrower for the benefit of any Guarantor nor to advise any Guarantor of any fact respecting, or any change in, the financial condition or affairs of the Borrower that might become known to any Guaranteed Party at any time, whether or not such Guaranteed Party knows or believes or has reason to know or believe that any such fact or change is unknown to any Guarantor, or might (or does) materially increase the risk of any Guarantor as guarantor, or might (or would) affect the willingness of any Guarantor to continue as a guarantor of the Guaranteed Obligations.

 

7.                                       Payments; Application; Setoff .

 

(a)                                  Each Guarantor agrees that, upon the failure of the Borrower to pay any Guaranteed Obligations when and as the same shall become due (whether at the stated maturity, by acceleration or otherwise), and without limitation of any other right or remedy that any Guaranteed Party may have at law, in equity or otherwise against such Guarantor, such Guarantor will, subject to the provisions of Section 1(b) , forthwith pay or cause to be paid to the

 

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Collateral Agent, for the benefit of the Guaranteed Parties, an amount equal to the amount of the Guaranteed Obligations then due and owing as aforesaid.

 

(b)                                  All payments made by each Guarantor hereunder will be made in Dollars to the Collateral Agent, without setoff, counterclaim or other defense and, in accordance with the Note Purchase Agreement, free and clear of and without deduction for any taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any Governmental Authority, including any interest, additions to tax or penalties applicable thereto, each Guarantor hereby agreeing to comply with and be bound by the provisions of the Note Purchase Agreement in respect of all payments made by it hereunder.

 

(c)                                   All payments made hereunder shall be applied in accordance with the provisions of Section 2.8 of the Note Purchase Agreement.

 

(d)                                  In the event that the proceeds of any sale, disposition or realization of the Collateral or otherwise are insufficient to pay all amounts to which the Guaranteed Parties are legally entitled, the Guarantors shall be jointly and severally liable for the deficiency, together with interest thereon at the highest rate specified in any applicable Credit Document for interest on overdue principal or such other rate as shall be fixed by applicable law, together with the costs of collection and all other fees, costs and expenses payable hereunder.

 

(e)                                   Upon and at any time after the occurrence and during the continuance of any Event of Default, each Guaranteed Party and each of their respective Affiliates is hereby authorized at any time and from time to time, to the fullest extent permitted by applicable law, to set off and apply any and all deposits (general or special, time or demand, provisional or final, in whatever currency) at any time held and other obligations (in whatever currency) at any time owing by such Guaranteed Party or any such Affiliate to or for the credit or the account of any Guarantor against any and all of the obligations of such Guarantor now or hereafter existing under this Guaranty or any other Credit Document to such Guaranteed Party, irrespective of whether or not such Guaranteed Party shall have made any demand under this Guaranty or any other Credit Document and although such obligations of such Guarantor may be contingent or unmatured or are owed to a branch or office of such Guaranteed Party different from the branch or office holding such deposit or obligated on such indebtedness.  The rights of each Guaranteed Party and their respective Affiliates under this Section 7(e)  are in addition to other rights and remedies (including other rights of setoff) that such Guaranteed Parties or their respective Affiliates may have.  Each Guaranteed Party agrees to notify the Borrower and the Collateral Agent promptly after any such setoff and application; provided that the failure to give such notice shall not affect the validity of such setoff and application.

 

8.                                       No Waiver .  The rights and remedies of the Guaranteed Parties expressly set forth in this Guaranty and the other Credit Documents are cumulative and in addition to, and not exclusive of, all other rights and remedies available at law, in equity or otherwise.  No failure or delay on the part of any Guaranteed Party in exercising any right, power or privilege shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or privilege preclude any other or further exercise thereof or the exercise of any other right, power or privilege or be construed to be a waiver of any Default or Event of Default.  No course of dealing between any of the Guarantors and the Guaranteed Parties or their agents or employees

 

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shall be effective to amend, modify or discharge any provision of this Guaranty or any other Credit Document or to constitute a waiver of any Default or Event of Default.  No notice to or demand upon any Guarantor in any case shall entitle such Guarantor or any other Guarantor to any other or further notice or demand in similar or other circumstances or constitute a waiver of the right of any Guaranteed Party to exercise any right or remedy or take any other or further action in any circumstances without notice or demand.

 

9.                                       Enforcement .  The Guaranteed Parties agree that, except as provided in Section 7(e) , this Guaranty may be enforced only by the Collateral Agent, acting upon the instructions or with the consent of the Required Purchasers as provided for in the Note Purchase Agreement, and that no Guaranteed Party shall have any right individually to enforce or seek to enforce this Guaranty or to realize upon any Collateral or other security given to secure the payment and performance of the Guarantors’ obligations hereunder.  The obligations of each Guarantor hereunder are independent of the Guaranteed Obligations, and a separate action or actions may be brought against each Guarantor whether or not action is brought against the Borrower or any other Guarantor and whether or not the Borrower or any other Guarantor is joined in any such action.  Each Guarantor agrees that to the extent all or part of any payment of the Guaranteed Obligations made by any Person is subsequently invalidated, declared to be fraudulent or preferential, set aside or required to be repaid by or on behalf of any Guaranteed Party to a trustee, receiver or any other Person under any Insolvency Laws (the amount of any such payment, a “ Reclaimed Amount ”), then, to the extent of such Reclaimed Amount, this Guaranty shall continue in full force and effect or be revived and reinstated, as the case may be, as to the Guaranteed Obligations intended to be satisfied as if such payment had not been received; and each Guarantor acknowledges that the term “Guaranteed Obligations” includes all Reclaimed Amounts that may arise from time to time.

 

10.                                Amendments, Waivers, etc .  No amendment, modification, waiver, discharge or termination of, or consent to any departure by any Guarantor from, any provision of this Guaranty, shall be effective unless in a writing signed by the Guarantors, the Collateral Agent and such of the Purchasers as may be required under Section 9.10 of the Note Purchase Agreement to concur in the action then being taken, and then the same shall be effective only in the specific instance and for the specific purpose for which given.

 

11.                                Addition, Release of Guarantors .  Subject to Section 8.8 of the Note Purchase Agreement, each Guarantor recognizes that the provisions of the Note Purchase Agreement require certain Persons that become Subsidiaries of the Borrower and that are not already parties hereto to become Guarantors hereunder by executing a Guarantor Accession, and agrees that its obligations hereunder shall not be discharged, limited or otherwise affected by reason of the same, or by reason of the Collateral Agent’s actions in effecting the same or in releasing any Guarantor hereunder, in each case without the necessity of giving notice to or obtaining the consent of any other Guarantor.

 

12.                                Continuing Guaranty; Term; Successors and Assigns; Assignment; Survival .  This Guaranty is a continuing guaranty and covers all of the Guaranteed Obligations as the same may arise and be outstanding at any time and from time to time from and after the date hereof, and shall (i) remain in full force and effect until satisfaction of all of the Termination Requirements ( provided that the provisions of Sections 1(a)(ii)  and 4 shall survive any termination of this

 

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Guaranty), (ii) be binding upon and enforceable against each Guarantor and its successors and assigns ( provided , however , that no Guarantor may sell, assign or transfer any of its rights, interests, duties or obligations hereunder without the prior written consent of all of the Purchasers) and (iii) inure to the benefit of and be enforceable by each Guaranteed Party and its successors and assigns.  Without limiting the generality of clause (iii) above, any Guaranteed Party may, in accordance with the provisions of the Note Purchase Agreement, assign all or a portion of the Guaranteed Obligations held by it (including by the sale of participations), whereupon each Person that becomes the holder of any such Guaranteed Obligations shall (except as may be otherwise agreed between such Guaranteed Party and such Person) have and may exercise all of the rights and benefits in respect thereof granted to such Guaranteed Party under this Guaranty or otherwise.  Each Guarantor hereby irrevocably waives notice of and consents in advance to the assignment as provided above from time to time by any Guaranteed Party of all or any portion of the Guaranteed Obligations held by it and of the corresponding rights and interests of such Guaranteed Party hereunder in connection therewith.  All representations, warranties, covenants and agreements herein shall survive the execution and delivery of this Guaranty and any Guarantor Accession.

 

13.                                Governing Law; Consent to Jurisdiction; Appointment of Borrower as Representative, Process Agent, Attorney-in-Fact .

 

(a)                                  This Guaranty and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Guaranty shall be governed by, and construed in accordance with, the laws of the State of New York (including Sections 5-1401 and 5-1402 of the New York General Obligations Law, but excluding all other choice of law and conflicts of law rules).

 

(b)                                  Each Guarantor irrevocably and unconditionally submits, for itself and its property, to the nonexclusive jurisdiction of the courts of the State of New York sitting in the City and County of New York and of the United States District Court of the Southern District of New York and any appellate court therefrom in any action or proceeding arising out of or relating to this Guaranty or any other Credit Document, or for recognition or enforcement of any judgment, and each of the parties hereto irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding may be heard and determined in such state court or, to the fullest extent permitted by applicable law, in such federal court.  Each of the parties hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.  Nothing in this Guaranty or in any other Credit Document shall affect any right that any Guaranteed Party may otherwise have to bring any action or proceeding relating to this Guaranty or any other Credit Document against any Guarantor or its properties in the courts of any jurisdiction.

 

(c)                                   Each Guarantor irrevocably and unconditionally waives, to the fullest extent permitted by applicable law, any objection that it may now or hereafter have to the laying of venue of any action or proceeding arising out of or relating to this Guaranty or any other Credit Document in any court referred to in Section 13(b) .  Each of the parties hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, the defense of an inconvenient forum to the maintenance of such action or proceeding in any such court.

 

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(d)                                  Each Guarantor hereby irrevocably designates and appoints the Borrower as its designee, appointee and agent to receive on its behalf all service of process in any such action or proceeding and any other notice or communication hereunder, irrevocably consents to service of process in any such action or proceeding by registered or certified mail directed to the Borrower at its address set forth in the Note Purchase Agreement (and service so made shall be deemed to be completed upon the earlier of actual receipt thereof or three business days after deposit in the United States mails, proper postage prepaid and properly addressed), and irrevocably agrees that service so made shall be effective and binding upon such Guarantor in every respect and that any other notice or communication given to the Borrower at the address and in the manner specified herein shall be effective notice to such Guarantor.  Nothing in this Section 13 shall affect the right of any party to serve legal process in any other manner permitted by law or affect the right of any Guaranteed Party to bring any action or proceeding against any Guarantor in the courts of any other jurisdiction.

 

(e)                                   Further, each Guarantor does hereby irrevocably make, constitute and appoint the Borrower as its true and lawful attorney-in-fact, with full authority in its place and stead and in its name, the Borrower’s name or otherwise, and with full power of substitution in the premises, from time to time in the Borrower’s discretion to agree on behalf of, and sign the name of, such Guarantor to any amendment, modification or supplement to, restatement of, or waiver or consent in connection with, this Guaranty, any other Credit Document or any document or instrument related hereto or thereto, and to take any other action and do all other things on behalf of such Guarantor that the Borrower may deem necessary or advisable to carry out and accomplish the purposes of this Guaranty and the other Credit Documents.  The Borrower will not be liable for any act or omission nor for any error of judgment or mistake of fact unless the same shall occur as a result of the gross negligence or willful misconduct of the Borrower.  This power, being coupled with an interest, is irrevocable by any Guarantor for so long as this Guaranty shall be in effect with respect to such Guarantor.  By its signature hereto, the Borrower consents to its appointment as provided for herein and agrees promptly to distribute all process, notices and other communications to each Guarantor.

 

14.                                Waiver of Jury Trial .  EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS GUARANTY OR ANY OTHER CREDIT DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).  EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PERSON HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PERSON WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS GUARANTY AND THE OTHER CREDIT DOCUMENTS BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.

 

15.                                Notices .  All notices and other communications provided for herein shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or

 

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registered mail or sent by facsimile as follows: (i) if to any Guarantor, in care of the Borrower and at the Borrower’s address for notices set forth in the Note Purchase Agreement, and (ii) if to the Borrower or any Guaranteed Party, at their respective addresses for notices set forth in the Note Purchase Agreement; in each case, as such addresses may be changed from time to time pursuant to the Note Purchase Agreement, and with copies to such other Persons as may be specified under the provisions of the Note Purchase Agreement.  Notices sent by hand or overnight courier service, or mailed by certified or registered mail, shall be deemed to have been given when received; notices sent by facsimile shall be deemed to have been given when sent (except that, if not given during normal business hours for the recipient, shall be deemed to have been given at the opening of business on the next business day for the recipient).  Notices delivered through electronic communications to the extent provided in the Note Purchase Agreement shall be effective as provided therein.

 

16.                                Severability .  To the extent any provision of this Guaranty is prohibited by or invalid under the applicable law of any jurisdiction, such provision shall be ineffective only to the extent of such prohibition or invalidity and only in such jurisdiction, without prohibiting or invalidating such provision in any other jurisdiction or the remaining provisions of this Guaranty in any jurisdiction.

 

17.                                Construction .  The headings of the various sections and subsections of this Guaranty have been inserted for convenience only and shall not in any way affect the meaning or construction of any of the provisions hereof.  Unless the context otherwise requires, words in the singular include the plural and words in the plural include the singular.  The provisions of Section 1.3 of the Note Purchase Agreement are hereby incorporated by reference as if fully set forth herein.

 

18.                                Counterparts; Effectiveness .  This Guaranty may be executed in any number of counterparts and by different parties hereto on separate counterparts, each of which when so executed and delivered shall be an original, but all of which shall together constitute one and the same instrument.  This Guaranty shall become effective, as to any Guarantor, upon the execution and delivery by such Guarantor of a counterpart hereof or a Guarantor Accession.  Delivery of an executed counterpart of a signature page of this Guaranty or a Guarantor Accession by facsimile or in electronic format (e.g., “pdf,” “tif” or similar file formats) shall be effective as delivery of a manually executed counterpart of this Guaranty or such Guarantor Accession.

 

[Signature pages follow]

 

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

 

 

 

[GUARANTOR]

 

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

[Signatures Continue on Following Page]

 

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Signature Page to Guaranty Agreement

 



 

Accepted and agreed to:

 

DEERFIELD PRIVATE DESIGN FUND III, L.P. , as Collateral Agent

 

 

 

By:

Deerfield Mgmt III, L.P.

 

 

General Partner

 

 

 

By:

J.E. Flynn Capital III, LLC

 

 

 

General Partner

 

 

 

 

 

By:

 

 

Name:

David J. Clark

 

Title:

Authorized Signatory

 

 

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Signature Page to Guaranty Agreement

 



 

EXHIBIT A

 

GUARANTOR ACCESSION

 

THIS GUARANTOR ACCESSION (this “ Accession ”), dated as of                           , 20        , is executed and delivered by [NAME OF NEW GUARANTOR] , a                              (the “ New Guarantor ”), pursuant to the Guaranty Agreement referred to below.

 

Reference is made to the Note Purchase Agreement, dated as of March 12, 2015, among Depomed, Inc., a California corporation (the “ Borrower ”), the Purchasers party thereto, and Deerfield Private Design Fund III, L.P., a Delaware limited partnership, as a Purchaser and as Collateral Agent for the Purchasers (as amended, modified, restated or supplemented from time to time, the “ Note Purchase Agreement ”).  In connection with and as a condition to the purchase of the Notes by the Purchasers under the Note Purchase Agreement, a Subsidiary of the Borrower, has executed and delivered a Guaranty Agreement, dated as of                             , 20     (as amended, modified, restated or supplemented from time to time, the “ Guaranty Agreement ”), pursuant to which Acquisition Sub has guaranteed the payment in full of the obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents (as defined in the Note Purchase Agreement).  Capitalized terms used herein without definition shall have the meanings given to them in the Guaranty Agreement.

 

The Borrower has agreed under the Note Purchase Agreement to cause certain of its future Subsidiaries to become a party to the Guaranty Agreement as a guarantor thereunder.  The New Guarantor is a Subsidiary of the Borrower that the Borrower is required to cause to become a party to the Guaranty Agreement.  The New Guarantor will obtain benefits as a result of sale of the Notes to the Purchasers by the Borrower under the Note Purchase Agreement, which benefits are hereby acknowledged, and, accordingly, desire to execute and deliver this Accession.  Therefore, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and as further inducement to the Purchasers in connection with their purchase of the Notes from the Borrower under the Note Purchase Agreement, the New Guarantor hereby agrees as follows:

 

1.                                       The New Guarantor hereby joins in and agrees to be bound by each and all of the provisions of the Guaranty Agreement as a Guarantor thereunder.  In furtherance (and without limitation) of the foregoing, pursuant to Section 1 of the Guaranty Agreement, the New Guarantor hereby irrevocably, absolutely and unconditionally, and jointly and severally with each other Guarantor, guarantees to the Guaranteed Parties the full and prompt payment, at any time and from time to time as and when due (whether at the stated maturity, by acceleration or otherwise), of all of the Guaranteed Obligations, and agrees to pay or reimburse upon demand all other obligations of the Guarantors under the Guaranty Agreement, all on the terms and subject to the conditions set forth in the Guaranty Agreement.

 

2.                                       The New Guarantor hereby represents and warrants that after giving effect to this Accession, each representation and warranty related to it contained in Sections 4.1, 4.2, 4.3, 4.4, 4.5 and 4.7 the Note Purchase Agreement is true and correct with respect to the New Guarantor as of the date hereof.

 

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3.                                       This Accession shall be a Credit Document (within the meaning of such term under the Note Purchase Agreement), shall be binding upon and enforceable against the New Guarantor and its successors and assigns, and shall inure to the benefit of and be enforceable by each Guaranteed Party and its successors and assigns.  This Accession and its attachments are hereby incorporated into the Guaranty Agreement and made a part thereof.

 

[Signature page follow]

 

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IN WITNESS WHEREOF , the New Guarantor has caused this Accession to be executed under seal by its duly authorized officer as of the date first above written.

 

 

 

[NAME OF NEW GUARANTOR]

 

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

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EXHIBIT F

 

FORM OF SECURITY AGREEMENT

 

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Schedule 4.11

Capitalization; Subsidiaries

 

SUBSIDIARY
NAME

 

JURISDICTION OF
ORGANIZATION

 

DIRECT
HOLDERS

 

NUMBER OF SHARES,
UNITS OR OTHER
INTERESTS OF EACH
CLASS OF CAPITAL STOCK

 

NUMBER OF SHARES,
UNITS OR OTHER
INTERESTS HELD BY
EACH DIRECT HOLDERS

Depo DR Sub, LLC

 

Delaware

 

Depomed, Inc.

 

100% of Units

 

100%

 

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and filed separately with the Securities Exchange Commission

 



 

Schedule 4.14

Ownership of Properties

 

OWNER OF PROPERTY

 

ADDRESS

 

NATURE OF USE OF THE
REMISES

 

NATURE OF
INTEREST

BMR-Pacific Research Center LP

 

7999 Gateway Boulevard, Suite 300

Newark, CA 94560

 

Chief Executive Office

 

Leasehold

 

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and filed separately with the Securities Exchange Commission

 



 

Schedule 6.2

Indebtedness

 

None

 

Confidential Information indicated by [***] has been omitted from this filing

and filed separately with the Securities Exchange Commission

 



 

Schedule 6.3

Liens

 

Liens represented by the following Uniform Commercial Code filings:

 

1.               UCC Financing Statement (#11-7260877978) filed in the California Secretary of State’s Office against Depomed, Inc. in favor of Konica Minolta Premier Finance. (filed for informational purposes only)

 

Confidential Information indicated by [***] has been omitted from this filing

and filed separately with the Securities Exchange Commission

 


Exhibit 10.2

 

CERTAIN MATERIAL (INDICATED BY [***] ) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

PLEDGE AND SECURITY AGREEMENT

 

THIS PLEDGE AND SECURITY AGREEMENT , dated as of the 2nd day of April, 2015 (this “ Agreement ”), is made by DEPOMED, INC. , a California corporation (the “ Borrower ”), by DEPO NF SUB, LLC , a Delaware limited liability company and a Subsidiary of the Borrower (“ Acquisition Subsidiary ”), and by each Subsidiary of the Borrower that, after the date hereof, executes an instrument of accession hereto substantially in the form of Exhibit C (a “ Pledgor Accession ”; such Subsidiaries, collectively, together with the Borrower and the Acquisition Subsidiary, the “ Pledgors ”), in favor of DEERFIELD PRIVATE DESIGN FUND III, L.P. , a Delaware limited partnership, as Collateral Agent for the Purchasers party to the Note Purchase Agreement referred to below (in such capacity, the “ Collateral Agent ”), for the benefit of the Secured Parties (as hereinafter defined).  Except as otherwise provided herein, capitalized terms used but not defined herein have the meanings given to them in the Note Purchase Agreement referred to below.

 

RECITALS

 

A.                                     The Borrower, the Purchasers and the Collateral Agent are parties to a Note Purchase Agreement, dated as of March 12, 2015 (as amended, modified, restated or supplemented from time to time, the “ Note Purchase Agreement ”), pursuant to which the Purchasers will purchase Notes with an aggregate original principal amount of $575,000,000 upon the terms and subject to the conditions set forth therein.

 

B.                                     As a condition to the purchase of the Notes by the Purchasers under the Note Purchase Agreement, the Acquisition Subsidiary has entered into a Guaranty Agreement, dated as of the date hereof (as amended, modified, restated or supplemented from time to time, the “ Guaranty Agreement ”), pursuant to which the Acquisition Subsidiary has guaranteed to the Secured Parties the payment in full of the Obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents.  Additionally, certain other Subsidiaries of the Borrower may from time to time after the date hereof enter into the Guaranty Agreement, pursuant to which such Subsidiaries will guarantee to the Secured Parties the payment in full of the Obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents.

 

C.                                     It is a further condition to the purchase by the Purchasers of the Notes under the Note Purchase Agreement that the Pledgors as of the date of the Note Purchase Agreement shall have agreed, by executing and delivering this Agreement, to secure the payment in full of their respective obligations under the Note Purchase Agreement, the Guaranty Agreement and the other Credit Documents.  The Secured Parties are relying on this Agreement in their decision to purchase the Notes from the Borrower under the Note Purchase Agreement, and would not enter

 

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

 



 

into the Note Purchase Agreement or purchase the Note thereunder without the execution and delivery of this Agreement by the Pledgors.

 

D.                                     The Pledgors will obtain benefits as a result of the sale by the Borrower of the Notes to the Purchasers under the Note Purchase Agreement, which benefits are hereby acknowledged, and, accordingly, desire to execute and deliver this Agreement.

 

STATEMENT OF AGREEMENT

 

NOW, THEREFORE , in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, to induce the Secured Parties to enter into the Note Purchase Agreement and to induce the Purchasers to purchase the Notes from the Borrower thereunder, each Pledgor hereby agrees as follows:

 

ARTICLE I

 

DEFINITIONS

 

1.1                                Defined Terms .  The following terms that are defined in the Uniform Commercial Code (as hereinafter defined) are used in this Agreement as so defined (and, in the event any such term is defined differently for purposes of Article 9 of the Uniform Commercial Code than for any other purpose or purposes of the Uniform Commercial Code, the Article 9 definition shall govern): Account, Chattel Paper, Commercial Tort Claim, Commodity Account, Commodity Intermediary, Deposit Accounts, Documents, Electronic Chattel Paper, Equipment, Fixtures, General Intangibles, Goods, Instruments, Inventory, Investment Property, Letter-of-Credit Rights, Record, Securities Account, Securities Intermediary, Software, Supporting Obligations and Tangible Chattel Paper.  In addition, the following terms have the meanings set forth below:

 

Collateral ” has the meaning given to such term in Section 2.1 .

 

Collateral Accounts ” has the meaning given to such term in Section 6.3 .

 

Contracts ” means, collectively, all rights of each Pledgor under all leases, contracts and agreements to which such Pledgor is now or hereafter a party, including, without limitation, all rights, privileges and powers under Ownership Agreements and Licenses, together with any and all extensions, modifications, amendments and renewals of such leases, contracts and agreements and all rights of such Pledgor to receive moneys due or to become due thereunder or pursuant thereto and to amend, modify, terminate or exercise rights under such leases, contracts and agreements.

 

Control Agreement ” has the meaning given to such term in Section 4.7 .

 

Copyright Collateral ” means, collectively, all Copyrights and inbound Copyright Licenses (other than off-the-shelf software and software subject to shrink-wrap, click-wrap and other generally commercially available licenses) to which any Pledgor is or hereafter becomes a party and all other General Intangibles embodying, incorporating, evidencing or otherwise

 

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

 

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relating or pertaining to any Copyright or Copyright License, in each case whether now owned or existing or hereafter acquired or arising.

 

Copyright License ” means any agreement now or hereafter in effect granting any right to any third party under any Copyright now or hereafter owned by any Pledgor or which any Pledgor otherwise has the right to license, or granting any right to any Pledgor under any property of the type described in the definition of Copyright herein now or hereafter owned by any third party, and all rights of any Pledgor under any such agreement.

 

Copyrights ” means, collectively, all of each Pledgor’s copyrights, copyright registrations and applications for copyright registration, whether under the laws of the United States or any other country or jurisdiction, including all recordings, supplemental registrations and derivative or collective work registrations, and all renewals and extensions thereof, in each case whether now owned or existing or hereafter acquired or arising.

 

Excluded Property ” means collectively, (i) any permit, license or agreement entered into by any Pledgor (A) to the extent that any such permit, license or agreement or any law applicable thereto prohibits the creation of a Lien thereon, but only to the extent, and for as long as, such prohibition is not terminated or rendered unenforceable or otherwise deemed ineffective by the Uniform Commercial Code or any other applicable law or (B) to the extent that the creation of a Lien in favor of the Collateral Agent would result in a breach or termination pursuant to the terms of or a default under any such permit, license or agreement (other than to the extent that any such term would be rendered ineffective pursuant to the Sections 9-406, 9-407, 9-408 or 9-409 of the Uniform Commercial Code or any other applicable law (including the Bankruptcy Code) or principles of equity), (ii) property owned by any Pledgor that is subject to a purchase money Lien or leased by any Pledgor that is subject to a Capital Lease, in each case, permitted under the Note Purchase Agreement if the agreement pursuant to which such Lien is granted (or in the document providing for such capital lease) (1) prohibits or requires the consent of any Person other than a Pledgor or one of its Affiliates which has not been obtained as a condition to the creation of any other Lien on such property or (2) grants a right of termination to any Person other than a Pledgor or one of its Affiliates if any Lien in favor of the Collateral Agent is created with respect to the property subject thereto, (iii) any “intent to use” trademark applications for which a statement of use has not been filed (but only until such statement is filed), (iv) Capital Stock in joint ventures or any non-Wholly Owned Subsidiaries to the extent not permitted by the terms of such entity’s organizational documents or joint venture documents, (v) voting Capital Stock in any Excluded Foreign Subsidiary in excess of 65% of the total combined voting power of all outstanding classes of Capital Stock in such Subsidiary (within the meaning of Section 1.956-2(c)(2) of the Treasury Regulations), (vi) rolling stock, motor vehicles, vessels and other assets subject to certificates of title (other than to the extent a Lien thereon can be perfected by the filing of a financing statement under the Uniform Commercial Code), (vii) any governmental licenses or state or local franchises, charters and authorizations, to the extent a security interest in any such license, franchise, charter or authorization is prohibited or restricted thereby (after giving effect to the applicable anti-assignment provisions of the Uniform Commercial Code or other applicable law), (viii) any assets (including intangibles) not located in the United States to the extent the grant of a security interest therein is restricted or prohibited by applicable law, and (ix) [***]; provided , however , “Excluded Property” shall not include any proceeds, products, substitutions or replacements of

 

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

 

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Excluded Property (unless such proceeds, products, substitutions or replacements would otherwise constitute Excluded Property).

 

Excluded Securities Account ” means (i) any Securities Account or Commodity Account where the aggregate value of the securities or commodities credited thereto does not at any time exceed [***] for such account or [***] for all such accounts, (ii) any Securities Account or Commodity Account where (A) the Collateral Agent is the entitlement holder or Commodity Intermediary or (B) the Securities Intermediary or Commodity Intermediary (as applicable) for such account has executed and delivered to the Collateral Agent a control agreement with respect to such Securities Account or Commodity Account in form and substance reasonably satisfactory to the Collateral Agent, (iii) any Securities Account or Commodity Account described in clause (ii) of the definition of Excluded Account, and (iv) any Securities Account or Commodity Account held outside the United States.

 

Guarantor ” has the meaning given such term in the Guaranty Agreement.

 

License ” means any Copyright License, Patent License or Trademark License.

 

Ownership Agreement ” means any partnership agreement, joint venture agreement, limited liability company operating agreement, stockholders agreement or other agreement creating, governing or evidencing any Capital Stock and to which any Pledgor is now or hereafter becomes a party, as any such agreement may be amended, modified, supplemented, restated or replaced from time to time.

 

Patent Collateral ” means, collectively, all Patents and all inbound Patent Licenses to which any Pledgor is or hereafter becomes a party and all other General Intangibles embodying, incorporating, evidencing or otherwise relating or pertaining to any Patent or Patent License, in each case whether now owned or existing or hereafter acquired or arising.

 

Patent License ” means any agreement now or hereafter in effect granting to any third party any right to make, use or sell any invention on which a Patent, now or hereafter owned by any Pledgor or which any Pledgor otherwise has the right to license, is in existence, or granting to any Pledgor any right to make, use or sell any invention on which property of the type described in the definition of Patent herein, now or hereafter owned by any third party, is in existence, and all rights of any Pledgor under any such agreement.

 

Patents ” means, collectively, all of each Pledgor’s letters patent, whether under the laws of the United States or any other country or jurisdiction, all recordings and registrations thereof and applications therefor, including, without limitation, the inventions and improvements described therein, and all reissues, continuations, divisions, renewals, extensions, substitutions and continuations-in-part thereof, in each case whether now owned or existing or hereafter acquired or arising.

 

Pledge Amendment ” has the meaning given such term in Section 5.1(a) .

 

Pledged Interests ” means, collectively, (i) all of the issued and outstanding Capital Stock of each Person that is a direct Subsidiary of any Pledgor as of the date hereof or that becomes a direct Subsidiary of any Pledgor at any time after the date hereof, at any time now or hereafter

 

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

 

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owned by any Pledgor, whether voting or non-voting and whether common or preferred; (ii) all options, warrants and other rights to acquire, and all securities convertible into, any of the foregoing; (iii) all rights to receive interest, income, dividends, distributions, returns of capital and other amounts (whether in cash, securities, property, or a combination thereof), and all additional stock, warrants, options, securities, interests and other property, from time to time paid or payable or distributed or distributable in respect of any of the foregoing (but subject to the provisions of Section 5.3 ), including, without limitation, all rights of such Pledgor to receive amounts due and to become due under or in respect of any Ownership Agreement or upon the termination thereof; (iv) all rights of access to the books and records of any such Person (other than with respect to the books and records held by Depo DR); and (v) all other rights, powers, privileges, interests, claims and other property in any manner arising out of or relating to any of the foregoing, of whatever kind or character (including any tangible or intangible property or interests therein), and whether provided by contract or granted or available under applicable law in connection therewith, including, without limitation, such Person’s right to vote and to manage and administer the business of any such Subsidiary pursuant to any applicable Ownership Agreement, in each case together with all certificates, instruments and entries upon the books of financial intermediaries at any time evidencing any of the foregoing.  Notwithstanding the foregoing, Pledged Interests shall not include any Excluded Property specified in clause (v) of the definition thereof.

 

Proceeds ” has the meaning given to such term in Section 2.1 .

 

Secured Parties ” means, collectively, the Purchasers and the Collateral Agent.

 

Secured Obligations ” has the meaning given such term in Section 2.2 .

 

Trademark Collateral ” means, collectively, all Trademarks and inbound Trademark Licenses to which any Pledgor is or hereafter becomes a party and all other General Intangibles embodying, incorporating, evidencing or otherwise relating or pertaining to any Trademark or Trademark License, in each case whether now owned or existing or hereafter acquired or arising.

 

Trademark License ” means any agreement now or hereafter in effect granting any right to any third party under any Trademark now or hereafter owned by any Pledgor or which any Pledgor otherwise has the right to license, or granting any right to any Pledgor under any property of the type described in the definition of Trademark herein now or hereafter owned by any third party, and all rights of any Pledgor under any such agreement.

 

Trademarks ” means, collectively, all of each Pledgor’s trademarks, service marks, trade names, corporate and company names, business names, logos, trade dress, trade styles, other source or business identifiers, designs and general intangibles of a similar nature, whether under the laws of the United States or any other country or jurisdiction, all recordings and registrations thereof and applications therefor, all renewals, reissues and extensions thereof, all rights corresponding thereto, and all goodwill associated therewith or symbolized thereby, in each case whether now owned or existing or hereafter acquired or arising.

 

Uniform Commercial Code ” means the Uniform Commercial Code as the same may be in effect from time to time in the State of New York; provided that if, by reason of applicable law, the validity, priority or perfection of any security interest in any Collateral granted under

 

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

 

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this Agreement is governed by the Uniform Commercial Code as in effect in another jurisdiction, then as to the validity, priority or perfection, as the case may be, of such security interest, “Uniform Commercial Code” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction.

 

1.2                                Other Terms; Construction .  All terms in this Agreement that are not capitalized shall, unless the context otherwise requires, have the meanings provided by the Uniform Commercial Code to the extent the same are used or defined therein.

 

ARTICLE II

 

CREATION OF SECURITY INTEREST

 

2.1                                Pledge and Grant of Security Interest .  Each Pledgor hereby pledges and collaterally assigns to the Collateral Agent, for the ratable benefit of the Secured Parties, and grants to the Collateral Agent, for the ratable benefit of the Secured Parties, a Lien upon and security interest in, all of such Pledgor’s right, title and interest in and to the following property and assets of such Pledgor, in each case whether now owned or existing or hereafter acquired or arising and wherever located (collectively, the “ Collateral ”):

 

(i)                                      all Accounts;

 

(ii)                                   all Chattel Paper;

 

(iii)                                the Commercial Tort Claims (if any) set forth on Annex I hereto;

 

(iv)                               all Contracts;

 

(v)                                  all Copyright Collateral;

 

(vi)                               all Deposit Accounts;

 

(vii)                            all Documents;

 

(viii)                         all Equipment;

 

(ix)                               all Fixtures;

 

(x)                                  all General Intangibles;

 

(xi)                               all Goods;

 

(xii)                            all Instruments;

 

(xiii)                         all Inventory;

 

(xiv)                        all Investment Property;

 

(xv)                           all Letter-of-Credit Rights;

 

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

 

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(xvi)                        all Patent Collateral;

 

(xvii)                     all Pledged Interests;

 

(xviii)                  all Software;

 

(xix)                        all Supporting Obligations;

 

(xx)                           all Trademark Collateral;

 

(xxi)                        all cash, cash equivalents and money of such Pledgor, wherever held;

 

(xxii)                     to the extent not covered or not specifically excluded by clauses (i) through (xxi) above, all of such Pledgor’s other personal property;

 

(xxiii)                  all Records evidencing or relating to any of the foregoing or that are otherwise necessary or useful in the collection thereof;

 

(xxiv)                 all accessions, additions, attachments, improvements, modifications and upgrades to, replacements of and substitutions for any of the foregoing; and

 

(xxv)                    any and all proceeds, as defined in the Uniform Commercial Code, products, rents, royalties and profits of or from any and all of the foregoing and, to the extent not otherwise included in the foregoing, (w) all payments under any insurance (whether or not the Collateral Agent is the loss payee thereunder), indemnity, warranty or guaranty with respect to any of the foregoing Collateral, (x) all payments in connection with any requisition, condemnation, seizure or forfeiture with respect to any of the foregoing Collateral, (y) all claims and rights (but not obligations) to recover for any past, present or future infringement or dilution of or injury to any Copyright Collateral, Patent Collateral or Trademark Collateral, and (z) all other amounts from time to time paid or payable under or with respect to any of the foregoing Collateral (collectively, “ Proceeds ”).  For purposes of this Agreement, the term “Proceeds” includes whatever is receivable or received when Collateral or Proceeds are sold, exchanged, collected or otherwise disposed of, whether voluntarily or involuntarily.

 

Notwithstanding the foregoing, (i) “Collateral” shall not include the Excluded Property, and (ii) the Collateral Agent may, in its sole discretion, reject or refuse to accept for credit toward payment of the Secured Obligations any Collateral that is an Account, Instrument, Chattel Paper, lease or other obligation or property of any kind due or owing from or belonging to a Sanctioned Person.

 

2.2                                Security for Secured Obligations .  This Agreement and the Collateral secure the full and prompt payment, at any time and from time to time as and when due (whether at the stated maturity, by acceleration or otherwise), of (a) in the case of the Borrower, all Obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents, including, without limitation, all principal of and interest on the Notes, and all fees, expenses, indemnities and other amounts payable by the Borrower under the Note Purchase Agreement or any other Credit Document (including interest accruing after the filing of a petition or commencement of a

 

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

 

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case by or with respect to the Borrower seeking relief under any applicable federal and state laws pertaining to bankruptcy, reorganization, arrangement, moratorium, readjustment of debts, dissolution, liquidation or other debtor relief, specifically including, without limitation, the Bankruptcy Code and any fraudulent transfer and fraudulent conveyance laws, whether or not the claim for such interest is allowed in such proceeding), and (b) in the case of each Pledgor other than the Borrower, if any, all of its liabilities and obligations as a Guarantor in respect of the Guaranteed Obligations (as defined in the Guaranty Agreement); and in each case under (a) and (b) above, (i) all such liabilities and obligations that, but for the operation of the automatic stay under Section 362(a) of the Bankruptcy Code, would become due, and (ii) all fees, costs and expenses payable by the Pledgors under Section 8.1, whether now existing or hereafter created or arising and whether direct or indirect, absolute or contingent, due or to become due (the liabilities and obligations of the Pledgors described in this Section 2.2 , collectively, the “ Secured Obligations ”).

 

ARTICLE III

 

REPRESENTATIONS AND WARRANTIES

 

Each Pledgor represents and warrants as follows:

 

3.1                                Ownership of Collateral .  Each Pledgor (i) holds interests as lessee under valid leases in full force and effect with respect to all material leased real and personal property used in connection with its business and (ii) has good title to all of its other material properties and assets reflected in the financial statements referred to in Section 4.9 of the Note Purchase Agreement (except as sold or otherwise disposed of since the date thereof in the ordinary course of business), in each case free and clear of all Liens other than Permitted Liens.  No security agreement, financing statement or other public notice with respect to all or any part of the Collateral is on file or of record in any government or public office, and no Pledgor has filed or consented to the filing of any such statement or notice, except (i) Uniform Commercial Code financing statements naming the Collateral Agent as secured party, (ii) security instruments filed in the U.S. Copyright Office or the U.S. Patent and Trademark Office naming the Collateral Agent as secured party, (iii) filings with respect to which termination statements and other necessary releases have been delivered to the Collateral Agent for filing or will be filed promptly on or after the date hereof (or the date of the applicable Pledgor Accession), (iv) Uniform Commercial Code financing statements and security instruments filed in the U.S. Copyright Office or the U.S. Patent and Trademark Office [***], and (v) as may be otherwise permitted by the Note Purchase Agreement.

 

3.2                                Security Interests; Filings .  This Agreement, together with (i) the filing, with respect to each Pledgor, of duly completed Uniform Commercial Code financing statements naming such Pledgor as debtor, the Collateral Agent as secured party, and describing the Collateral, in the jurisdictions set forth with respect to such Pledgor on Annex A hereto, (ii) to the extent required by applicable law, the filing, with respect to each relevant Pledgor, of duly completed and executed assignments in the forms set forth as Exhibits A and B with the U.S. Copyright Office or the U.S. Patent and Trademark Office, as appropriate, with regard to registered Copyright Collateral, Patent Collateral and Trademark Collateral of such Pledgor, as the case may be, (iii) in the case of uncertificated Pledged Interests consisting of capital stock, registration of transfer thereof to the Collateral Agent on the issuer’s books or the execution by

 

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

 

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the issuer of a control agreement satisfying the requirements of Section 8-106 (or its successor provision) of the Uniform Commercial Code, and (iv) the delivery to the Collateral Agent, for its benefit and the benefit of the Secured Parties, of all stock certificates and Instruments included in the Collateral (and assuming continued possession thereof by the Collateral Agent), creates, and at all times shall constitute, a valid and perfected security interest in and Lien upon the Collateral in favor of the Collateral Agent, for the benefit of the Secured Parties, to the extent a security interest therein can be perfected by such filings or possession, as applicable, superior and prior to the rights of all other Persons therein (except for Permitted Liens), and no other or additional filings, registrations, recordings or actions are or shall be necessary or appropriate in order to maintain the perfection and priority of such Lien and security interest, other than actions required with respect to Collateral of the types excluded from Article 9 of the Uniform Commercial Code or from the filing requirements under such Article 9 by reason of Section 9 109, 9-309 or 9 310 of the Uniform Commercial Code and other than continuation statements required under the Uniform Commercial Code.

 

3.3                                Locations Annex B lists, as to each Pledgor, (i) its exact legal name, (ii) the jurisdiction of its incorporation or organization, its federal tax identification number, and (if applicable) its organizational identification number, (iii) the addresses of its chief executive office and each other place of business, (iv) the address of each location of all original invoices, ledgers, Chattel Paper, Instruments and other records or information evidencing or relating to the Collateral of such Pledgor, and (v) the address of each location at which any Equipment or Inventory (other than Goods in transit and mobile goods) having a book value in excess of [***] and owned by such Pledgor is kept or maintained, in each instance except for any new locations established in accordance with the provisions of Section 4.1 .  Except as may be otherwise noted therein, all locations identified in Annex B are leased by the applicable Pledgor. No Pledgor (x) presently conducts or has conducted business under any prior or other corporate or company name or under any trade or fictitious names, except as indicated beneath its name on Annex B or (y) has filed any tax return under any name other than its exact legal name, except as indicated beneath its name on Annex B .

 

3.4                                Authorization; Consent .  No authorization, consent or approval of, or declaration or filing with, any Governmental Authority (including, without limitation, any notice filing with state tax or revenue authorities required to be made by account creditors in order to enforce any Accounts in such state) is required for the valid execution, delivery and performance by any Pledgor of this Agreement, the grant by it of the Lien and security interest in favor of the Collateral Agent provided for herein, or the exercise by the Collateral Agent of its rights and remedies hereunder, except for (i) the filings described in Section 3.2 , (ii) in the case of Accounts owing from any federal governmental agency or authority, the filing by the Collateral Agent of a notice of assignment in accordance with the federal Assignment of Claims Act of 1940, as amended, (iii) in the case of Pledged Interests, such filings and approvals as may be required in connection with a disposition of any such Pledged Interests by laws affecting the offering and sale of securities generally, (iv) authorizations, consents, approvals, declarations or filings relating to the possession and sale or other disposition of any controlled substances, and (v) authorizations, consents, approvals, declarations or filings relating to the transfer or assignment of any Collateral constituting Regulatory Approvals.

 

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

 

9



 

3.5                                No Restrictions .  There are no statutory or regulatory restrictions, prohibitions or limitations on any Pledgor’s ability to grant to the Collateral Agent a Lien upon and security interest in the Collateral pursuant to this Agreement or (except for (i) the provisions of the federal Anti-Assignment Act, as amended, and Assignment of Claims Act of 1940, as amended, (ii) any statutory or regulatory restrictions, prohibitions or limitations relating to the possession and sale or other disposition of any controlled substances and (iii) any statutory or regulatory restrictions, prohibitions or limitations applicable to the transfer of any Collateral constituting Regulatory Approvals) on the exercise by the Collateral Agent of its rights and remedies hereunder (including any foreclosure upon or collection of the Collateral), and there are no contractual restrictions on any Pledgor’s ability to grant such Lien and security interest.

 

3.6                                Accounts .  Each Account is, or at the time it arises will be not evidenced by any Tangible Chattel Paper or other Instrument; or if so, such Tangible Chattel Paper or other Instrument valued individually in excess of [***] or [***] in the aggregate (other than invoices and related correspondence and supporting documentation) shall promptly be duly endorsed to the order of the Collateral Agent and delivered to the Collateral Agent to be held as Collateral hereunder.

 

3.7                                Pledged Interests .  As of the date hereof, the Pledged Interests required to be pledged hereunder by each Pledgor consist of the number and type of shares of capital stock (in the case of issuers that are corporations) or the percentage and type of other equity interests (in the case of issuers other than corporations) as described beneath such Pledgor’s name in Annex C .  All of the Pledged Interests (other than with respect to non-Wholly Owned Subsidiaries and joint ventures), and to such Pledgor’s knowledge, all of the Pledged Interests with respect to non-Wholly Owned Subsidiaries and joint ventures, have been duly and validly issued and are fully paid and nonassessable (or, in the case of partnership, limited liability company or similar Pledged Interests, not subject to any capital call or other additional capital requirement) and not subject to any preemptive rights, warrants, options or similar rights or restrictions in favor of third parties or any contractual or other restrictions upon transfer.  As to each issuer thereof, the Pledged Interests pledged hereunder constitute 100% or 65%, as applicable, of the outstanding Capital Stock of such issuer, except as set forth in Annex C .

 

3.8                                Intellectual Property Annexes D E and F correctly set forth all registered Copyrights, Patents and Trademarks owned by any Pledgor as of the date hereof (and as amended from time to time pursuant to Section 4.5 ) and used or proposed to be used in its business.

 

3.9                                Deposit Accounts Annex G lists, as of the date hereof (and as amended from time to time pursuant to Section 4.7 ), all Deposit Accounts maintained by any Pledgor, and lists in each case the name in which the account is held, the name of the depository institution, the account number, and a description of the type or purpose of the account.

 

3.10                         Securities and Commodity Accounts Annex H lists, as of the date hereof (and as amended from time to time pursuant to Section 4.8 ), all Securities Accounts and Commodity Accounts maintained by any Pledgor with any Securities Intermediary or Commodity Intermediary, and lists in each case the name in which the account is held, the name of the Securities Intermediary or Commodity Intermediary, the account number, and a description of the type or purpose of the account.

 

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

 

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3.11                         Documents of Title .  No bill of lading, warehouse receipt or other Document or Instrument of title is outstanding with respect to any Collateral other than Inventory in transit in the ordinary course of business to a location set forth on Annex B or to a customer of a Pledgor.

 

3.12                         Commercial Tort Claims Annex I lists, as of the date hereof and to the knowledge of each Pledgor, all Commercial Tort Claims valued individually in excess of [***] existing in favor of any Pledgor.

 

ARTICLE IV

 

COVENANTS

 

4.1                                Change of Name, Locations, etc .  No Pledgor will (i) change its name, identity or corporate structure, (ii) change its chief executive office from the location thereof listed on Annex B , (iii) change the jurisdiction of its incorporation or organization from the jurisdiction listed on Annex B (whether by merger or otherwise), (iv) file any document with the Internal Revenue Service using any name other than its exact legal name listed on Annex B , or (v)  remove any books, records or other information relating to the regulatory approvals, clinical studies or Intellectual Property related to a Material Product, from the applicable location thereof listed on Annex B , unless in each case such Pledgor has (1) given [***] (or such later date as may be agreed to by the Collateral Agent in its sole discretion) prior written notice to the Collateral Agent of its intention to do so, together with information regarding any such new location and such other information in connection with such proposed action as the Collateral Agent may reasonably request, and (2) delivered to the Collateral Agent [***] following the Collateral Agent’s request any documents, instruments or financing statements as may be reasonably required by the Collateral Agent, all in form and substance reasonably satisfactory to the Collateral Agent, paid all necessary filing and recording fees and taxes, and taken all other actions reasonably requested by the Collateral Agent, in order to perfect and maintain the Lien upon and security interest in the Collateral provided for herein in accordance with the provisions of Section 3.2 .

 

4.2                                Reserved .

 

4.3                                Accounts .  Each Pledgor shall promptly notify the Collateral Agent in writing of any Accounts that constitute a claim valued individually in excess of [***] against a federal governmental agency or authority, and, upon request of the Collateral Agent, such Pledgor shall take such steps as may be necessary or desirable to comply with the federal Assignment of Claims Act of 1940, as amended.

 

4.4                                Delivery of Certain Collateral; Further Actions .  All (i) certificates or (ii) Instruments representing or evidencing any Accounts, Investment Property or other Collateral valued individually in excess of [***] or [***] in the aggregate shall be delivered promptly to the Collateral Agent pursuant hereto to be held as Collateral hereunder, shall be in form suitable for transfer by delivery and shall be delivered together with undated stock powers duly executed in blank, appropriate endorsements or other necessary instruments of registration, transfer or assignment, duly executed and in form and substance satisfactory to the Collateral Agent, and in each case together with such other instruments or documents as the Collateral Agent may reasonably request.  Each Pledgor will, at its own cost and expense, use commercially reasonable efforts to

 

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

 

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cooperate with the Collateral Agent in obtaining a control agreement, in form and substance reasonably satisfactory to the Collateral Agent, and in taking such other actions as may be reasonably requested by the Collateral Agent from time to time with respect to any Investment Property or other Collateral in which a security interest may be perfected by (or can be perfected only by) control under the Uniform Commercial Code.

 

4.5                                Intellectual Property .

 

(a)                                  Each applicable Pledgor will, at its own expense, execute and deliver to the Collateral Agent on the Closing Date fully completed assignments in the forms of Exhibits A and B , as applicable, for recordation in the U.S. Copyright Office or the U.S. Patent and Trademark Office with regard to any Copyright Collateral, Patent Collateral or Trademark Collateral, as the case may be, described in Annex D E or F hereto.  Within [***] after the close of each fiscal quarter of the Borrower, the Borrower shall provide written notice of any additional registrations of or applications for Copyrights, Patents or Trademarks of all Pledgors with the U.S. Copyright Office or the U.S. Patent and Trademark Office, as applicable, together with information sufficient to permit the Collateral Agent, upon its receipt of such notice, to (and each Pledgor hereby authorizes the Collateral Agent to) modify this Agreement, as appropriate, by amending Annexes D E and F hereto or to add additional exhibits hereto to include any Copyright, Patent or Trademark that becomes part of the Collateral under this Agreement, and such Pledgor shall additionally, at its own expense, execute and deliver to the Collateral Agent, with regard to United States Patents, Trademarks and Copyrights, fully completed assignments in the forms of Exhibits A and B , as applicable, for recordation in the U.S. Copyright Office or the U.S. Patent and Trademark Office as more fully described hereinabove, together in all instances with any other agreements, instruments and documents that the Collateral Agent may reasonably request from time to time to further effect and confirm the assignment and security interest created by this Agreement in such Copyrights, Patents and Trademarks, and each Pledgor hereby appoints the Collateral Agent its attorney-in-fact to execute, deliver and record any and all such agreements, instruments and documents for the foregoing purposes, all acts of such attorney being hereby ratified and confirmed and such power, being coupled with an interest, shall be irrevocable for so long as this Agreement shall be in effect with respect to such Pledgor.

 

(b)                                  Upon the occurrence and during the continuance of any Event of Default, each Pledgor shall use commercially reasonable efforts to obtain all requisite consents or approvals from the licensor of each License included within the Copyright Collateral, Patent Collateral or Trademark Collateral to effect the assignment of all of such Pledgor’s right, title and interest thereunder to the Collateral Agent or its designee.

 

4.6                                Reserved .

 

4.7                                Deposit Accounts .  Subject to Section 5.13 of the Note Purchase Agreement, each Pledgor agrees that, unless the Collateral Agent consents otherwise in writing, (i) it will not open or maintain any Deposit Account (other than Excluded Accounts) except with a bank or financial institution that has executed and delivered to the Collateral Agent a control agreement with respect to such Deposit Account in form and substance reasonably satisfactory to the Collateral Agent (each a, “ Control Agreement ”), and (ii) in the event any Pledgor opens any Deposit Account not already listed on Annex G , such Pledgor shall (in addition to complying with the other requirements of this Section) promptly furnish written notice thereof to the Collateral

 

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

 

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Agent together with information sufficient to permit the Collateral Agent, upon its receipt of such notice, to (and each Pledgor hereby authorizes the Collateral Agent to) modify this Agreement, as appropriate, by amending Annex G to include such information.

 

4.8                                Securities and Commodity Accounts.   Subject to Section 5.13 of the Note Purchase Agreement, each Pledgor agrees that, unless the Collateral Agent consents otherwise in writing, (i) it will not open or maintain any Securities Account or Commodity Account (other than Excluded Securities Accounts) unless the Collateral Agent is the entitlement holder or Commodity Intermediary or unless the Securities Intermediary or Commodity Intermediary (as applicable) has executed and delivered to the Collateral Agent a control agreement with respect to such Securities Account or Commodity Account in form and substance reasonably satisfactory to the Collateral Agent, and (ii) in the event any Pledgor opens any Securities Account or Commodity Account not already listed on Annex H , such Pledgor shall (in addition to complying with the other requirements of this Section) promptly furnish written notice thereof to the Collateral Agent together with information sufficient to permit the Collateral Agent, upon its receipt of such notice, to (and each Pledgor hereby authorizes the Collateral Agent to) modify this Agreement, as appropriate, by amending Annex H to include such information.

 

4.9                                Collateral in Possession of Third Party .  Without limiting the generality of any other provision of this Agreement, each Pledgor agrees that it shall not permit any Collateral consisting of an NDA, regulatory approvals, clinical studies or Intellectual Property related to a Material Product to be in the possession of any bailee, warehouseman, agent, processor or other third party at any time unless such bailee or other Person (i) shall have been notified of the security interest created by this Agreement and (ii) such Pledgor shall have used commercially reasonable efforts to have such bailee or other Person execute a written agreement with the Collateral Agent pursuant to which it (1) acknowledges that it is holding such Collateral for the benefit of the Collateral Agent and subject to such security interest and to the instructions of the Collateral Agent and (2) agrees to waive and release or subordinate any Lien (whether arising by operation of law or otherwise) it may have with respect to such Collateral, such agreement to be in form and substance reasonably satisfactory to the Collateral Agent.  The Borrower agrees to pay any reasonable and documented out-of-pocket costs and expenses incurred by the Collateral Agent in obtaining the agreement specified in the foregoing clause (ii).

 

4.10                         Commercial Tort Claims .  Each Pledgor agrees that it will, promptly upon the filing of any suit, action or proceeding relating to any Commercial Tort Claim involving damages in excess of [***] in its favor, furnish to the Collateral Agent a description thereof meeting the requirements of Section 9-108(e) of the Uniform Commercial Code, execute and deliver such documents, financing statements and other instruments, and take such other action, as the Collateral Agent may reasonably request in order to include such Commercial Tort Claim as Collateral hereunder and to perfect the security interest of the Collateral Agent therein.

 

4.11                         Protection of Security Interest .  Subject to Section 5.12 of the Note Purchase Agreement, each Pledgor agrees that it will, at its own cost and expense, take any and all actions necessary to warrant and defend the right, title and interest of the Secured Parties in and to the Collateral against the claims and demands of all other Persons.

 

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

 

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ARTICLE V

 

CERTAIN PROVISIONS RELATING TO PLEDGED INTERESTS

 

5.1                                After-Acquired Equity Interests; Ownership .

 

(a)                                  Subject to Section 5.9 of the Note Purchase Agreement, if any Pledgor shall, at any time and from time to time after the date hereof, acquire any additional Capital Stock in any Person of the types described in the definition of the term “ Pledged Interests ,” the same shall be automatically deemed to be Pledged Interests hereunder, and to be pledged to the Collateral Agent pursuant to Section 2.1 , and such Pledgor will pledge and deposit the same with the Collateral Agent and deliver to the Collateral Agent any certificates therefor, together with undated stock powers or other necessary instruments of transfer or assignment, duly executed in blank and in form and substance reasonably satisfactory to the Collateral Agent, together with such other certificates and instruments as the Collateral Agent may reasonably request (including Uniform Commercial Code financing statements or appropriate amendments thereto), and will promptly thereafter deliver to the Collateral Agent a fully completed and duly executed amendment to this Agreement in the form of Exhibit D (each, a “ Pledge Amendment ”) in respect thereof.  Each Pledgor hereby authorizes the Collateral Agent to attach each such Pledge Amendment to this Agreement, and agrees that all such Collateral listed on any Pledge Amendment shall for all purposes be deemed Collateral hereunder and shall be subject to the provisions hereof; provided that the failure of any Pledgor to execute and deliver any Pledge Amendment with respect to any such additional Collateral as required hereinabove shall not impair the security interest of the Collateral Agent in such Collateral or otherwise adversely affect the rights and remedies of the Collateral Agent hereunder with respect thereto.

 

(b)                                  If any Pledged Interests (whether now owned or hereafter acquired) included in the Collateral are “uncertificated securities” within the meaning of the Uniform Commercial Code or are otherwise not evidenced by any certificate or instrument, each applicable Pledgor will promptly notify the Collateral Agent thereof and will promptly take and cause to be taken, and will (if the issuer of such uncertificated securities is a Person other than a Subsidiary of the Borrower) use best efforts to cause the issuer to take, all actions required under Articles 8 and 9 of the Uniform Commercial Code and any other applicable law, to enable the Collateral Agent to acquire “control” of such uncertificated securities (within the meaning of such term under Section 8-106 (or its successor provision) of the Uniform Commercial Code) and as may be otherwise necessary to perfect the security interest of the Collateral Agent therein.

 

5.2                                Voting Rights .  So long as no Event of Default shall have occurred and be continuing, each Pledgor shall be entitled to exercise all voting and other consensual rights pertaining to its Pledged Interests (subject to its obligations under Section 5.1(a) ), and for that purpose the Collateral Agent will execute and deliver or cause to be executed and delivered to each applicable Pledgor all such proxies and other instruments as such Pledgor may reasonably request in writing to enable such Pledgor to exercise such voting and other consensual rights; provided , however , that no Pledgor will cast any vote, give any consent, waiver or ratification, or take or fail to take any action, in any manner that would reasonably be expected to, violate or be inconsistent with any of the terms of this Agreement, the Note Purchase Agreement or any other Credit Document or have the effect of materially and adversely impairing the position or interests of the Secured Parties.

 

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

 

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5.3                                Dividends and Other Distributions .  All interest, income, dividends, distributions and other amounts payable in cash in respect of the Pledged Interests may be paid to and retained by the Pledgors; provided , however , that all such interest, income, dividends, distributions and other amounts shall, upon the written election of the Collateral Agent after the occurrence and during the continuance of an Event of Default, be paid to the Collateral Agent and retained by it as part of the Collateral (except to the extent applied upon receipt to the repayment of the Secured Obligations).  The Collateral Agent shall also be entitled at all times (whether or not during the continuance of an Event of Default), to receive directly, and to retain as part of the Collateral, (i) all additional Pledged Interests or other securities or property (other than cash) paid or payable or distributed or distributable in respect of any Pledged Interests in connection with any noncash dividend, distribution, return of capital, spin-off, stock split, split-up, reclassification, combination of shares or interests or similar rearrangement, and (ii) without affecting any restrictions against such actions contained in the Note Purchase Agreement, all additional Pledged Interests or other securities or property (including cash) paid or payable or distributed or distributable in respect of any Pledged Interests in connection with any consolidation, merger, exchange of securities, liquidation or other reorganization.  All interest, income, dividends, distributions or other amounts that are received by any Pledgor in violation of the provisions of this Section 5.3 shall be received in trust for the benefit of the Collateral Agent, shall be segregated from other property or funds of such Pledgor and shall be forthwith delivered to the Collateral Agent as Collateral in the same form as so received (with any necessary endorsements).  Any and all property paid over to or received by the Collateral Agent pursuant to the provisions of this Section 5.3 shall be retained by the Collateral Agent in a Collateral Account (as hereinafter defined) upon receipt of such property and shall be applied in accordance with the provisions of Section 6.2 .  The Collateral Agent shall, within [***] after all Events of Default have been cured or waived, repay to each applicable Pledgor all cash interest, income, dividends, distributions and other amounts that such Pledgor would otherwise be permitted to retain pursuant to the provisions of this Section 5.3 and that remain in such Collateral Account.

 

ARTICLE VI

 

REMEDIES

 

6.1                                Remedies .  If an Event of Default shall have occurred and be continuing, the Collateral Agent shall be entitled to exercise in respect of the Collateral all of its rights, powers and remedies provided for herein or otherwise available to it under any other Credit Document, by law, in equity or otherwise, including all rights and remedies of a secured party under the Uniform Commercial Code, and shall be entitled in particular, but without limitation of the foregoing, to exercise the following rights, which each Pledgor agrees to be commercially reasonable:

 

(a)                                  To notify any or all account debtors or obligors under any Accounts, Contracts or other Collateral of the security interest in favor of the Collateral Agent created hereby and to direct all such Persons to make payments of all amounts due thereon or thereunder directly to the Collateral Agent or to an account designated by the Collateral Agent; and in such instance and from and after such notice, all amounts and Proceeds (including wire transfers, checks and other Instruments) received by any Pledgor in respect of any Accounts, Contracts or other Collateral shall be received in trust for the benefit of the Collateral Agent hereunder, shall be segregated from the other funds of such Pledgor and shall be forthwith deposited into such account or paid

 

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

 

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over or delivered to the Collateral Agent in the same form as so received (with any necessary endorsements or assignments), to be held as Collateral and applied to the Secured Obligations as provided herein; and by this provision, each Pledgor irrevocably authorizes and directs each Person who is or shall be a party to or liable for the performance of any Contract, upon receipt of notice from the Collateral Agent to the effect that an Event of Default has occurred and is continuing, to attorn to or otherwise recognize the Collateral Agent as owner under such Contract and to pay, observe and otherwise perform the obligations under such Contract to or for the Collateral Agent or the Collateral Agent’s designee as though the Collateral Agent or such designee were such Pledgor named therein, and to do so until otherwise notified by the Collateral Agent;

 

(b)                                  To take possession of, receive, endorse, assign and deliver, in its own name or in the name of any Pledgor, all checks, notes, drafts and other Instruments relating to any Collateral, including receiving and opening of all mail addressed to any Pledgor concerning Accounts and other Collateral; to verify with account debtors or other contract parties the validity, amount or any other matter relating to any Accounts or other Collateral, in its own name or in the name of any Pledgor; to accelerate any Indebtedness or other obligation constituting Collateral that may be accelerated in accordance with its terms; to take or bring all actions and suits deemed necessary or appropriate to effect collections and to enforce payment of any Accounts or other Collateral; to settle, compromise or release in whole or in part any amounts owing on Accounts or other Collateral; and to extend the time of payment of any and all Accounts or other amounts owing under any Collateral and to make allowances and adjustments with respect thereto, all in the same manner and to the same extent as any Pledgor might have done;

 

(c)                                   To notify any or all depository institutions with which any Deposit Accounts are maintained and which Deposit Accounts are subject to control in favor of the Collateral Agent to remit and transfer all monies, securities and other property on deposit in such Deposit Accounts or deposited or received for deposit thereafter to the Collateral Agent, for deposit in a Collateral Account or such other accounts as may be designated by the Collateral Agent, for application to the Secured Obligations as provided herein;

 

(d)                                  To transfer to or register in its name or the name of any of its Collateral Agents or nominees all or any part of the Collateral, without notice to any Pledgor and with or without disclosing that such Collateral is subject to the security interest created hereunder;

 

(e)                                   To require any Pledgor to, and each Pledgor hereby agrees that it will at its expense and upon request of the Collateral Agent forthwith, assemble all or any part of the Collateral as directed by the Collateral Agent and make it available to the Collateral Agent at a place designated by the Collateral Agent (subject to any restrictions under applicable law relating to the possession and sale or other disposition of any controlled substances);

 

(f)                                    To enter and remain upon the premises of any Pledgor and take possession of all or any part of the Collateral, with or without judicial process; to use the materials, services, books and records of any Pledgor for the purpose of liquidating or collecting the Collateral, whether by foreclosure, auction or otherwise; and to remove the same to the premises of the Collateral Agent or any designated agent for such time as the Collateral Agent may desire, in

 

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

 

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order to effectively collect or liquidate the Collateral (in each case, subject to customary limitations relating to the possession and sale or other disposition of any controlled substances);

 

(g)                                   To exercise (i) all voting, consensual and other rights and powers pertaining to the Pledged Interests (whether or not transferred into the name of the Collateral Agent), at any meeting of shareholders, partners, members or otherwise, and (ii) any and all rights of conversion, exchange, subscription and any other rights, privileges or options pertaining to the Pledged Interests as if it were the absolute owner thereof (including, without limitation, the right to exchange at its discretion any and all of the Pledged Interests upon the merger, consolidation, reorganization, reclassification, combination of shares or interests, similar rearrangement or other similar fundamental change in the structure of the applicable issuer, or upon the exercise by any Pledgor or the Collateral Agent of any right, privilege or option pertaining to such Pledged Interests), and in connection therewith, the right to deposit and deliver any and all of the Pledged Interests with any committee, depositary, transfer agent, registrar or other designated agency upon such terms and conditions as the Collateral Agent may determine, and give all consents, waivers and ratifications in respect of the Pledged Interests, all without liability except to account for any property actually received by it, but the Collateral Agent shall have no duty to exercise any such right, privilege or option or give any such consent, waiver or ratification and shall not be responsible for any failure to do so or delay in so doing; and for the foregoing purposes each Pledgor will promptly execute and deliver or cause to be executed and delivered to the Collateral Agent, upon request, all such proxies and other instruments as the Collateral Agent may reasonably request to enable the Collateral Agent to exercise such rights and powers; AND IN FURTHERANCE OF THE FOREGOING AND WITHOUT LIMITATION THEREOF, DURING THE CONTINUATION OF AN EVENT OF DEFAULT, EACH PLEDGOR HEREBY IRREVOCABLY CONSTITUTES AND APPOINTS THE COLLATERAL AGENT AS THE TRUE AND LAWFUL PROXY AND ATTORNEY-IN-FACT OF SUCH PLEDGOR, WITH FULL POWER OF SUBSTITUTION IN THE PREMISES, TO EXERCISE ALL SUCH VOTING, CONSENSUAL AND OTHER RIGHTS AND POWERS TO WHICH ANY HOLDER OF ANY PLEDGED INTERESTS WOULD BE ENTITLED BY VIRTUE OF HOLDING THE SAME, WHICH PROXY AND POWER OF ATTORNEY, BEING COUPLED WITH AN INTEREST, IS IRREVOCABLE AND SHALL BE EFFECTIVE FOR SO LONG AS THIS AGREEMENT SHALL BE IN EFFECT; and

 

(h)                                  To sell, resell, assign and deliver, in its sole discretion, all or any of the Collateral, in one or more parcels (subject to any restrictions under applicable law relating to the possession and sale or other disposition of any controlled substances and any legal or statutory restrictions applicable to the transfer of any Collateral constituting Regulatory Approvals), on any securities exchange on which any Pledged Interests may be listed, at public or private sale, at any of the Collateral Agent’s offices or elsewhere, for cash, upon credit or for future delivery, at such time or times and at such price or prices and upon such other terms as the Collateral Agent may deem satisfactory.  If any of the Collateral is sold by the Collateral Agent upon credit or for future delivery, the Collateral Agent shall not be liable for the failure of the purchaser to purchase or pay for the same and, in the event of any such failure, the Collateral Agent may resell such Collateral.  In no event shall any Pledgor be credited with any part of the Proceeds of sale of any Collateral until and to the extent cash payment in respect thereof has actually been received by the Collateral Agent.  Each purchaser at any such sale shall hold the property sold absolutely, free from any claim or right of whatsoever kind, including any equity or right of redemption of

 

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

 

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any Pledgor, and each Pledgor hereby expressly waives all rights of redemption, stay or appraisal, and all rights to require the Collateral Agent to marshal any assets in favor of such Pledgor or any other party or against or in payment of any or all of the Secured Obligations, that it has or may have under any rule of law or statute now existing or hereafter adopted.  No demand, presentment, protest, advertisement or notice of any kind (except any notice required by law, as referred to below), all of which are hereby expressly waived by each Pledgor, shall be required in connection with any sale or other disposition of any part of the Collateral.  If any notice of a proposed sale or other disposition of any part of the Collateral shall be required under applicable law, the Collateral Agent shall give the applicable Pledgor at least [***] prior notice of the time and place of any public sale and of the time after which any private sale or other disposition is to be made, which notice each Pledgor agrees is commercially reasonable.  The Collateral Agent shall not be obligated to make any sale of Collateral if it shall determine not to do so, regardless of the fact that notice of sale may have been given.  The Collateral Agent may, without notice or publication, adjourn any public or private sale or cause the same to be adjourned from time to time by announcement at the time and place fixed for sale, and such sale may, without further notice, be made at the time and place to which the same was so adjourned.  Upon each public sale and, to the extent permitted by applicable law, upon each private sale, the Collateral Agent may purchase all or any of the Collateral being sold, free from any equity, right of redemption or other claim or demand, and may make payment therefor by endorsement and application (without recourse) of the Secured Obligations in lieu of cash as a credit on account of the purchase price for such Collateral.

 

6.2                                Application of Proceeds .

 

(a)                                  All Proceeds collected by the Collateral Agent upon any sale, other disposition of or realization upon any of the Collateral, together with all other moneys received by the Collateral Agent hereunder, shall be applied in accordance with Section 2.8 of the Note Purchase Agreement.

 

(b)                                  In the event that the proceeds of any such sale, disposition or realization are insufficient to pay all amounts to which the Secured Parties are legally entitled, the Pledgors shall be jointly and severally liable for the deficiency, together with interest thereon at the highest rate specified in any applicable Credit Document for interest on overdue principal or such other rate as shall be fixed by applicable law, together with the costs of collection and all other fees, costs and expenses payable hereunder, subject to Section 9.1 of the Note Purchase Agreement.

 

(c)                                   Upon any sale of any Collateral hereunder by the Collateral Agent (whether by virtue of the power of sale herein granted, pursuant to judicial proceeding, or otherwise), the receipt of the Collateral Agent or the officer making the sale shall be a sufficient discharge to the purchaser or purchasers of the Collateral so sold, and such purchaser or purchasers shall not be obligated to see to the application of any part of the purchase money paid over to the Collateral Agent or such officer or be answerable in any way for the misapplication thereof.

 

6.3                                Collateral Accounts .  Upon the occurrence and during the continuance of an Event of Default, the Collateral Agent shall have the right to cause to be established and maintained, at its principal office or such other location or locations as it may establish from time to time in its discretion, one or more accounts (collectively, “ Collateral Accounts ”) for the

 

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

 

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collection of cash Proceeds of the Collateral.  Such Proceeds, when deposited, shall continue to constitute Collateral for the Secured Obligations and shall not constitute payment thereof until applied as herein provided.  The Collateral Agent shall have sole dominion and control over all funds deposited in any Collateral Account, and such funds may be withdrawn therefrom only by the Collateral Agent.  Upon the occurrence and during the continuance of an Event of Default, the Collateral Agent shall have the right to (and, if directed by the Purchasers pursuant to the Note Purchase Agreement, shall) apply amounts held in the Collateral Accounts in payment of the Secured Obligations in the manner provided for in Section 6.2 .

 

6.4                                Grant of License .  Upon the occurrence and during the continuance of an Event of Default, each Pledgor hereby grants to the Collateral Agent a non-exclusive license (exercisable without payment of royalty or other compensation to any Pledgor) to use, license or sublicense any Patent Collateral, Trademark Collateral or Copyright Collateral now owned or licensed or hereafter acquired or licensed by such Pledgor, wherever the same may be located throughout the world, for such term or terms, on such conditions and in such manner as the Collateral Agent shall determine, whether general, special or otherwise, and whether on an exclusive or nonexclusive basis, and including in such license reasonable access to all media in which any of the licensed items may be recorded or stored and to all computer software and programs used for the compilation or printout thereof; provided , however that nothing in this Section 6.4   shall require Pledgors to grant any license in any Patent Collateral, Trademark Collateral or Copyright Collateral to the extent a grant of such license or sublicense would violate any Patent License, Trademark License or Copyright License applicable to such Collateral.  The use of such license or sublicense by the Collateral Agent shall be exercised, at the option of the Collateral Agent, only upon the occurrence and during the continuation of an Event of Default; provided that any license, sublicense or other transaction entered into by the Collateral Agent in accordance herewith shall be binding upon each applicable Pledgor notwithstanding any subsequent cure of an Event of Default.

 

6.5                                Private Sales .

 

(a)                                  Each Pledgor recognizes that the Collateral Agent may be compelled, at any time after the occurrence and during the continuance of an Event of Default, to conduct any sale of all or any part of the Pledged Interests without registering or qualifying such Pledged Interests under the Securities Act and/or any applicable state securities laws in effect at such time.  Each Pledgor acknowledges that any such private sales may be made in such manner and under such circumstances as the Collateral Agent may deem necessary or advisable in its sole and absolute discretion, including at prices and on terms that might be less favorable than those obtainable through a public sale without such restrictions (including, without limitation, a public offering made pursuant to a registration statement under the Securities Act), and, notwithstanding such circumstances, agrees that any such sale shall not be deemed not to have been made in a commercially reasonable manner solely because it was conducted as a private sale, and agrees that the Collateral Agent shall have no obligation to conduct any public sales and no obligation to delay the sale of any Pledged Interests for the period of time necessary to permit its registration for public sale under the Securities Act and applicable state securities laws, and shall not have any responsibility or liability as a result of its election so not to conduct any such public sales or delay the sale of any Pledged Interests, notwithstanding the possibility that a substantially higher price might be realized if the sale were deferred until after such registration.

 

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

 

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Each Pledgor hereby waives any claims against the Collateral Agent or any other Secured Party arising by reason of the fact that the price at which any Pledged Interests may have been sold at any private sale was less than the price that might have been obtained at a public sale or was less than the aggregate amount of the Secured Obligations, even if the Collateral Agent accepts the first offer received and does not offer such Pledged Interests to more than one offeree.

 

(b)                                  Each Pledgor agrees to use commercially reasonable efforts to do or cause to be done all such other acts as may be necessary to make such sale or sales of any portion of the Collateral pursuant to Section 6.1 and this Section 6.5 valid and binding and in compliance with all applicable Requirements of Law.  Each Pledgor agrees that a breach of any of the covenants contained in this Section 6.5 will cause irreparable injury to the Collateral Agent and the other Secured Parties, that the Collateral Agent and the other Secured Parties have no adequate remedy at law in respect of such breach and, as a consequence, that each and every covenant contained in this Section 6.5 shall be specifically enforceable against the Pledgors.

 

6.6                                The Pledgors Remain Liable .  Notwithstanding anything herein to the contrary, (i) each Pledgor shall remain liable under all Contracts to which it is a party included within the Collateral (including, without limitation, all Ownership Agreements) to perform all of its obligations thereunder to the same extent as if this Agreement had not been executed, (ii) the exercise by the Collateral Agent of any of its rights or remedies hereunder shall not release any Pledgor from any of its obligations under any of such Contracts, and (iii) except as specifically provided for hereinbelow, the Collateral Agent shall not have any obligation or liability by reason of this Agreement under any of such Contracts, nor shall the Collateral Agent be obligated to perform any of the obligations or duties of any Pledgor thereunder or to take any action to collect or enforce any claim for payment assigned hereunder.  The powers, rights and remedies conferred on the Collateral Agent hereunder are solely to protect its interest and privilege in such Contracts, as Collateral, and shall not impose any duty upon it to exercise any such powers, rights or remedies.

 

6.7                                Waivers .  Each Pledgor, to the greatest extent not prohibited by applicable law, hereby (i) agrees that it will not invoke, claim or assert the benefit of any rule of law or statute now or hereafter in effect (including, without limitation, any right to prior notice or judicial hearing in connection with the Collateral Agent’s possession, custody or disposition of any Collateral or any appraisal, valuation, stay, extension, moratorium or redemption law), or take or omit to take any other action, that would reasonably be expected to have the effect of delaying, impeding or preventing the exercise of any rights and remedies in respect of the Collateral, the absolute sale of any of the Collateral or the possession thereof by any purchaser at any sale thereof, and waives the benefit of all such laws and statutes and further agrees that it will not hinder, delay or impede the execution of any power granted hereunder to the Collateral Agent, but that it will permit the execution of every such power as though no such laws or statutes were in effect, (ii) waives all rights that it has or may have under any rule of law or statute now existing or hereafter adopted to require the Collateral Agent to marshal any Collateral or other assets in favor of such Pledgor or any other party or against or in payment of any or all of the Secured Obligations, and (iii) waives all rights that it has or may have under any rule of law or statute now existing or hereafter adopted to demand, presentment, protest, advertisement or notice of any kind (except notices expressly provided for herein).  In addition, each Pledgor

 

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

 

20



 

waives any and all rights of contribution or subrogation upon the sale or disposition of all or any portion of the Collateral by the Collateral Agent.

 

ARTICLE VII

 

THE COLLATERAL AGENT

 

7.1                                The Collateral Agent; Standard of Care .  The Collateral Agent will hold all items of the Collateral at any time received under this Agreement in accordance with the provisions hereof and will exercise reasonable care with respect thereto.  The obligations of the Collateral Agent as holder of the Collateral and interests therein and with respect to the disposition thereof, and otherwise under this Agreement and the other Credit Documents, are only those expressly set forth in this Agreement and the other Credit Documents.  The Collateral Agent shall act hereunder at the direction, or with the consent, of the Purchasers on the terms and conditions set forth in the Note Purchase Agreement.  The powers conferred on the Collateral Agent hereunder are solely to protect its interest, on behalf of the Secured Parties, in the Collateral, and shall not impose any duty upon it to exercise any such powers.  Except for treatment of the Collateral in its possession in a manner substantially equivalent to that which the Collateral Agent, in its individual capacity, accords its own property of a similar nature, which standard shall in no event be less than reasonable care, and the accounting for moneys actually received by it hereunder, the Collateral Agent shall have no duty as to any Collateral or as to the taking of any necessary steps to preserve rights against prior parties or any other rights pertaining to the Collateral.  Neither the Collateral Agent nor any other Secured Party shall be liable to any Pledgor (i) for any loss or damage sustained by such Pledgor, or (ii) for any loss, damage, depreciation or other diminution in the value of any of the Collateral that may occur as a result of or in connection with or that is in any way related to any exercise by the Collateral Agent or any other Secured Party of any right or remedy under this Agreement, any failure to demand, collect or realize upon any of the Collateral or any delay in doing so, or any other act or failure to act on the part of the Collateral Agent or any other Secured Party, except to the extent that the same is caused by its own gross negligence or willful misconduct.

 

7.2                                Further Assurances; Attorney-in-Fact .

 

(a)                                  Each Pledgor hereby irrevocably authorizes the Collateral Agent at any time and from time to time to file in any filing office in any Uniform Commercial Code jurisdiction any financing statements and amendments thereto that (a) indicate the Collateral (i) as all assets of such Pledgor or words of similar effect, regardless of whether any particular asset included within the Collateral falls within the scope of Article 9 of the Uniform Commercial Code of any such jurisdiction, or (ii) as being of an equal or lesser scope or with greater detail, and (b) provide any other information required by Part 5 of Article 9 of the Uniform Commercial Code for the sufficiency or filing office acceptance of any financing statement or amendment.

 

(b)                                  Each Pledgor agrees that it will do such further acts and things (including, without limitation, making any notice filings with state tax or revenue authorities required to be made by account creditors in order to enforce any Accounts in such state) and execute and deliver to the Collateral Agent such additional conveyances, assignments, agreements and instruments as the Collateral Agent may reasonably deem necessary to perfect, establish, confirm and maintain the security interest and Lien provided for herein, to carry out the purposes of this Agreement or to

 

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

 

21



 

further assure and confirm unto the Collateral Agent its rights, powers and remedies hereunder (in each case, subject to Section 5.12 of the Note Purchase Agreement).

 

(c)                                   Each Pledgor hereby irrevocably appoints the Collateral Agent its lawful attorney-in-fact, with full authority in the place and stead of such Pledgor and in the name of such Pledgor, the Collateral Agent or otherwise, and with full power of substitution in the premises (which power of attorney, being coupled with an interest, is irrevocable for so long as this Agreement shall be in effect), from time to time in the Collateral Agent’s discretion after the occurrence and during the continuance of an Event of Default (except for the actions described in clause (i) below, which may be taken by the Collateral Agent without regard to whether an Event of Default has occurred) to take any action and to execute any instruments that the Collateral Agent may deem necessary or advisable to accomplish the purpose of this Agreement, including, without limitation:

 

(i)                                      to sign the name of such Pledgor on any financing statement, continuation statement, notice or other similar document that, in the Collateral Agent’s reasonable judgment, is necessary in order to perfect or continue perfected the security interest granted under this Agreement;

 

(ii)                                   to ask, demand, collect, sue for, recover, compound, receive and give acquittance and receipts for moneys due and to become due under or in respect of any of the Collateral;

 

(iii)                                to receive, endorse and collect any checks, drafts, Instruments, Chattel Paper and other orders for the payment of money made payable to such Pledgor representing any interest, income, dividend, distribution or other amount payable in respect of any of the Collateral and to give full discharge for the same;

 

(iv)                               to obtain, maintain and adjust any property or casualty insurance required to be maintained by such Pledgor under Section 5.7 of the Note Purchase Agreement and direct the payment of proceeds thereof to the Collateral Agent;

 

(v)                                  to pay or discharge taxes, Liens or other encumbrances levied or placed on or threatened against the Collateral, the legality or validity thereof and the amounts necessary to discharge the same to be determined by the Collateral Agent in its sole discretion, any such payments made by the Collateral Agent to become Secured Obligations of the Pledgors to the Collateral Agent, due and payable immediately and without demand;

 

(vi)                               to file any claims or take any action or institute any proceedings that the Collateral Agent may deem necessary or advisable for the collection of any of the Collateral or otherwise to enforce the rights of the Collateral Agent with respect to any of the Collateral; and

 

(vii)                            to use, sell, assign, transfer, pledge, make any agreement with respect to or otherwise deal with any and all of the Collateral as fully and completely as though the Collateral Agent were the absolute owner of the Collateral for all purposes, and to do from time to time, at the Collateral Agent’s option and the Pledgors’ expense, all other

 

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

 

22



 

acts and things deemed necessary by the Collateral Agent to protect, preserve or realize upon the Collateral and to more completely carry out the purposes of this Agreement.

 

(d)                                  If any Pledgor fails to perform any covenant or agreement contained in this Agreement after written request to do so by the Collateral Agent ( provided that no such request shall be necessary at any time after the occurrence and during the continuance of an Event of Default), the Collateral Agent may itself perform, or cause the performance of, such covenant or agreement and may take any other action that it deems necessary and appropriate for the maintenance and preservation of the Collateral or its security interest therein, and the reasonable expenses so incurred in connection therewith shall be payable by the Pledgors under Section 8.1 .

 

ARTICLE VIII

 

MISCELLANEOUS

 

8.1                                Indemnity and Expenses .  Subject to Section 9.1 or 9.2 of the Note Purchase Agreement, the Pledgors agree jointly and severally to indemnify and hold harmless the Collateral Agent, each other Secured Party and each of their Related Parties from and against any and all claims, damages, demands, losses, obligations, judgments and liabilities (including, without limitation, reasonable and documented out of pocket attorneys’ fees and expenses) in any way arising out of or in connection with this Agreement and the transactions contemplated hereby, except to the extent the same shall arise as a result of the gross negligence or willful misconduct of the party seeking to be indemnified.

 

8.2                                No Waiver .  The rights and remedies of the Secured Parties expressly set forth in this Agreement and the other Credit Documents are cumulative and in addition to, and not exclusive of, all other rights and remedies available at law, in equity or otherwise.  No failure or delay on the part of any Secured Party in exercising any right, power or privilege shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or privilege preclude any other or further exercise thereof or the exercise of any other right, power or privilege or be construed to be a waiver of any Default or Event of Default.  No course of dealing between the Pledgors and the Secured Parties or their agents or employees shall be effective to amend, modify or discharge any provision of this Agreement or any other Credit Document or to constitute a waiver of any Default or Event of Default.  No notice to or demand upon any Pledgor in any case shall entitle such Pledgor or any other Pledgor to any other or further notice or demand in similar or other circumstances or constitute a waiver of the right of any Secured Party to exercise any right or remedy or take any other or further action in any circumstances without notice or demand.

 

8.3                                Enforcement .  By its acceptance of the benefits of this Agreement, each Purchaser agrees that this Agreement may be enforced only by the Collateral Agent, acting upon the instructions or with the consent of the Purchasers as provided for in the Note Purchase Agreement, and that no Purchaser shall have any right individually to enforce or seek to enforce this Agreement or to realize upon any Collateral or other security given to secure the payment and performance of the Secured Obligations.

 

8.4                                Amendments, Waivers, etc .  No amendment, modification, waiver, discharge or termination of, or consent to any departure by any Pledgor from, any provision of this

 

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

 

23



 

Agreement, shall be effective unless in a writing signed by the Collateral Agent and such of the Purchasers as may be required under Section 9.10 of the Note Purchase Agreement to concur in the action then being taken, and then the same shall be effective only in the specific instance and for the specific purpose for which given.

 

8.5                                Continuing Security Interest; Term; Successors and Assigns; Assignment; Termination and Release; Survival .  This Agreement shall create a continuing security interest in the Collateral and shall secure the payment and performance of all of the Secured Obligations as the same may arise and be outstanding at any time and from time to time from and after the date hereof, and shall (i) remain in full force and effect until the occurrence of the Termination Requirements (as hereinafter defined), (ii) be binding upon and enforceable against each Pledgor and its successors and assigns ( provided , however , that no Pledgor may sell, assign or transfer any of its rights, interests, duties or obligations hereunder without the prior written consent of the Purchasers) and (iii) inure to the benefit of and be enforceable by each Secured Party and its successors and assigns.  Upon any sale or other disposition by any Pledgor of any Collateral in a transaction expressly permitted hereunder or under or pursuant to the Note Purchase Agreement or any other applicable Credit Document, the Lien and security interest created by this Agreement in and upon such Collateral shall be automatically released, and upon the satisfaction of all of the Termination Requirements, this Agreement and the Lien and security interest created hereby shall terminate ( provided , that the provisions of Section 6.7 shall survive the termination of this Agreement); and in connection with any such release or termination, the Collateral Agent, at the request and expense of the applicable Pledgor, will execute and deliver to such Pledgor such documents and instruments evidencing such release or termination as such Pledgor may reasonably request and will assign, transfer and deliver to such Pledgor, without recourse and without representation or warranty, such of the Collateral as may then be in the possession of the Collateral Agent (or, in the case of any partial release of Collateral, such of the Collateral so being released as may be in its possession).  All representations, warranties, covenants and agreements herein shall survive the execution and delivery of this Agreement and any Pledgor Accession.  For purposes of this Agreement, “ Termination Requirements ” means (x) the payment in full in cash of the Secured Obligations (other than contingent and indemnification obligations not then due and payable), and (y) the termination of the Commitments.

 

8.6                                Additional Pledgors .  Each Pledgor recognizes that the provisions of the Note Purchase Agreement require certain Persons that become Subsidiaries of the Borrower, and that are not already parties hereto, to execute and deliver a Pledgor Accession, whereupon each such Person shall become a Pledgor hereunder with the same force and effect as if originally a Pledgor hereunder on the date hereof, and agrees that its obligations hereunder shall not be discharged, limited or otherwise affected by reason of the same, or by reason of the Collateral Agent’s actions in effecting the same or in releasing any Pledgor hereunder, in each case without the necessity of giving notice to or obtaining the consent of such Pledgor or any other Pledgor.

 

8.7                                Notices .  All notices and other communications provided for hereunder shall be given to the parties in the manner and subject to the other notice provisions set forth in the Note Purchase Agreement and the Guaranty Agreement.

 

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

 

24



 

8.8                                Governing Law .  This Agreement and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Agreement shall be governed by, and construed in accordance with, the law of the State of New York.

 

8.9                                Severability .  To the extent any provision of this Agreement is prohibited by or invalid under the applicable law of any jurisdiction, such provision shall be ineffective only to the extent of such prohibition or invalidity and only in such jurisdiction, without prohibiting or invalidating such provision in any other jurisdiction or the remaining provisions of this Agreement in any jurisdiction.

 

8.10                         Construction .  The headings of the various articles, sections and subsections of this Agreement have been inserted for convenience only and shall not in any way affect the meaning or construction of any of the provisions hereof.  Unless the context otherwise requires, words in the singular include the plural and words in the plural include the singular.  The provisions of Section 1.3 of the Note Purchase Agreement are hereby incorporated by reference as if fully set forth herein.

 

8.11                         Counterparts .  This Agreement may be executed in counterparts (and by different parties hereto in different counterparts), each of which shall constitute an original, but all of which when taken together shall constitute a single contract.  Delivery of an executed counterpart of a signature page of this Agreement by facsimile or in electronic format (e.g., “pdf,” “tif” or similar file formats) shall be effective as delivery of a manually executed counterpart of this Agreement.

 

[T he remainder of this page left blank intentionally.]

 

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

 

25



 

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

 

 

DEPOMED, INC.

 

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

Name:

James A. Schoeneck

 

Title:

President and Chief Executive Officer

 

 

 

 

DEPO NF SUB, LLC

 

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

Name:

James A. Schoeneck

 

Title:

President and Chief Executive Officer

 

 

Depomed, Inc., Member

 

(signatures continued)

 

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

 

Signature Page to Pledge and Security Agreement

 



 

Accepted and agreed to:

 

DEERFIELD PRIVATE DESIGN FUND III, L.P. ,

as Collateral Agent

 

 

 

 

 

 

By:

Deerfield Mgmt III, L.P.

 

 

General Partner

 

 

 

 

By:

J.E. Flynn Capital III, LLC

 

 

 

General Partner

 

 

 

By:

/s/ David J. Clark

 

Name:

David J. Clark

Title:

Authorized Signatory

 

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

 

Signature Page to Pledge and Security Agreement

 



 

ANNEX A

 

FILING LOCATIONS

 

Name of Pledgor

 

Filing Location

 

Depomed, Inc.

 

Secretary of state of the state of California

 

 

 

 

 

Depo NF Sub, LLC

 

Secretary of state of the state of Delaware

 

 

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

 



 

ANNEX B

 

JURISDICTION OF ORGANIZATION, CERTAIN LOCATIONS

 

Pledgor : Depomed, Inc .

 

Jurisdiction of Incorporation/Organization: California

 

Federal Tax ID no.: 94-3229046

 

Organizational ID no.: C1945473

 

Chief Executive Office Address: 7999 Gateway Boulevard, Suite 300, Newark, CA 94560

 

Locations of Records Related to Collateral: 7999 Gateway Boulevard, Suite 300, Newark, CA 94560

 

Locations of Equipment or Inventory:

 

Owner of Property

 

Address

 

Nature of Use of the
Premises

 

Nature of Interest

BMR-Pacific Research Center LP

 

7999 Gateway Boulevard, Suite 300
Newark, CA 94560

 

Chief Executive Office

 

Leasehold

Integrated Commercialization Solutions, Inc.

 

345 International Blvd., Brooks, KY 4019; and
5360 Capital Court #102, Reno, NV 89502

 

Logistics provider facility

 

Third party commercial outsourcing

DPT Lakewood, LLC

 

1200 Paco Way, Lakewood, NJ 08701

 

Lazanda® manufacturer

 

Third party manufacturer

Janssen Ortho LLC

 

State Road 933 Km 0.1, Mamey Ward, Gurabo, PR 00778-9629

 

NUCYNTA® manufacturer

 

Third party manufacturer

Patheon Puerto Rico, Inc.

 

Villa Blanca Industrial Park, State Road No. 1, Km. 34.8, Jose Garrido Avenue, Caguas, Puerto Rico 00725; and
State Road 670, Km 2.7, State Road 670 Km 2.7, Manati, Puerto Rico 00674

 

Gralise® manufacturer

 

Third party manufacturer

Accucaps Industries Limited

 

2125 Ambassador Drive, Windwor Ontario, Canada

 

Zipsor® manufactuer

 

Third party manufacturer

Mipharm S.p.A.

 

Via B. Quaranta 12, Milan, Italy

 

CAMBIA® manufacturer

 

Third party manufacturer

 

Other places of business: N/A

 

Trade/fictitious or prior corporate names
(last five years): N/A

 

Pledgor : Depo NF Sub, LLC

 

Jurisdiction of Incorporation/Organization: Delaware

 

Federal Tax ID no.: 47-3552536

 

Organizational ID no.: 5718378

 

Chief Executive Office Address: 7999 Gateway Boulevard, Suite 300, Newark, CA 94560

 

Locations of Records Related to Collateral: 7999 Gateway Boulevard, Suite 300, Newark, CA 94560

 

Locations of Equipment or Inventory:

 

Owner of Property

 

Address

 

Nature of Use of the
Premises

 

Nature of Interest

BMR-Pacific Research Center LP

 

7999 Gateway Boulevard, Suite 300
Newark, CA 94560

 

Chief Executive Office

 

Leasehold of Depomed, Inc.

 

Other places of business: N/A

 

Trade/fictitious or prior corporate names
(last five years): N/A

 

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

 



 

ANNEX C

 

PLEDGED INTERESTS

 

Pledgor

 

Name of Issuer

 

Type of Interests

 

Certificate
Number

 

No. of shares
(if applicable)

 

Percentage of
Outstanding
Interests
in Issuer

 

Depomed, Inc.

 

Depo DR Sub, LLC

 

Units

 

N/A

 

N/A

 

100%

 

Depomed, Inc.

 

Depo NF Sub, LLC

 

Units

 

1

 

100

 

100%

 

 

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

 



 

ANNEX D

 

COPYRIGHTS AND COPYRIGHT APPLICATIONS

 

[N/A]

 

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

 



 

ANNEX E

 

PATENTS AND PATENT APPLICATIONS

 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

CA

 

Depomed, Inc.

 

2409552.00

 

23-Oct-2002

 

Abandoned

 

 

 

 

 

 

 

 

 

EPO

 

Depomed, Inc.

 

2786524.50

 

25-Oct-2002

 

Abandoned

 

 

 

 

 

 

 

 

 

JP

 

Depomed, Inc.

 

2003537608.00

 

25-Oct-2002

 

Abandoned

 

2005507000

 

10-Mar-2005

 

 

 

 

 

MX

 

Depomed, Inc.

 

PA/A/2004/003930

 

25-Oct-2002

 

Abandoned

 

P04/586F

 

01-Dec-2004

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2002/034297

 

25-Oct-2002

 

NAT PHASE

 

WO 2003/035041

 

01-May-2003

 

 

 

 

 

TW

 

Depomed, Inc.

 

91124776.00

 

24-Oct-2002

 

Granted

 

 

 

 

 

I324075

 

01-May-2010

 

US

 

Depomed, Inc.

 

10/045816

 

25-Oct-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

10/024932

 

18-Dec-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

10/769574

 

29-Jan-2004

 

Granted

 

US2004-0185105A1

 

23-Sep-2004

 

7976870

 

12-Jul-2011

 

US

 

Depomed, Inc.

 

13/153211

 

03-Jun-2011

 

Pending

 

US-2011-0301129-A1

 

08-Dec-2011

 

 

 

 

 

US

 

Depomed, Inc.

 

13/684155

 

21-Nov-2012

 

Pending

 

US 2013-0149379 A1

 

13-Jun-2013

 

 

 

 

 

US

 

Depomed, Inc.

 

10/280309

 

25-Oct-2002

 

Granted

 

 

 

 

 

7438927

 

21-Oct-2008

 

US

 

Depomed, Inc.

 

10/903879

 

30-Jul-2004

 

Granted

 

 

 

 

 

7612112

 

03-Nov-2009

 

US

 

Depomed, Inc.

 

11/322448

 

29-Dec-2005

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

11/648134

 

29-Dec-2006

 

Abandoned

 

US-2007-0184104-A1

 

09-Aug-2007

 

 

 

 

 

US

 

Depomed, Inc.

 

61/065442

 

11-Feb-2008

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

586185.00

 

09-Dec-2008

 

Abandoned

 

US-2009-0176882-A1

 

09-Jul-2009

 

 

 

 

 

US

 

Depomed, Inc.

 

12/239591

 

26-Sep-2008

 

Granted

 

US2009-0017121A1

 

15-Jan-2009

 

7731989

 

08-Jun-2010

 

US

 

Depomed, Inc.

 

12/563781

 

21-Sep-2009

 

Granted

 

US-2010-0034895-A1

 

11-Feb-2010

 

8119166

 

21-Feb-2012

 

US

 

Depomed, Inc.

 

12/749101

 

29-Mar-2010

 

Granted

 

US-2010-0247610-A1

 

30-Sep-2010

 

8252332

 

28-Aug-2012

 

US

 

Depomed, Inc.

 

13/111575

 

19-May-2011

 

Granted

 

US-2011-056223-A1

 

20-Oct-2011

 

8192756

 

05-Jun-2012

 

US

 

Depomed, Inc.

 

13/110522

 

18-May-2011

 

Pending

 

US-2011-0218246-A1

 

08-Sep-2011

 

 

 

 

 

US

 

Depomed, Inc.

 

13/301570

 

21-Nov-2011

 

Granted

 

US-2012-0128735-A1

 

24-May-2012

 

8475813

 

02-Jul-2013

 

US

 

Depomed, Inc.

 

13/270126

 

10-Oct-2011

 

Granted

 

US-2012-0027823-A1

 

02-Feb-2012

 

8440232

 

14-May-2013

 

US

 

Depomed, Inc.

 

13/301602

 

21-Nov-2011

 

Granted

 

US-2012-0064168-A1

 

15-Mar-2012

 

8529955

 

10-Sep-2013

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Depomed, Inc.

 

13/301644

 

21-Nov-2011

 

Granted

 

US-2012-0064129-A1

 

15-Mar-2012

 

8231905

 

31-Jul-2012

 

US

 

Depomed, Inc.

 

13/396441

 

14-Feb-2012

 

Granted

 

US-2012-0148671-A1

 

14-Jun-2012

 

8409613

 

02-Apr-2013

 

US

 

Depomed, Inc.

 

13/553622

 

19-Jul-2012

 

Granted

 

US-2012-0282307-A1

 

08-Nov-2012

 

8333991

 

18-Dec-2012

 

US

 

Depomed, Inc.

 

13/560938

 

27-Jul-2012

 

Granted

 

US-2012-0289601-A1

 

15-Nov-2012

 

8333992

 

18-Dec-2012

 

US

 

Depomed, Inc.

 

13/854433

 

01-Apr-2013

 

Granted

 

US-2013-0224289-A1

 

29-Aug-2013

 

8580303

 

12-Nov-2013

 

US

 

Depomed, Inc.

 

13/943500

 

16-Jul-2013

 

Granted

 

US-2013-0302417-A1

 

14-Nov-2013

 

8802157

 

12-Aug-2014

 

US

 

Depomed, Inc.

 

14/075965

 

08-Nov-2013

 

Pending

 

US-2014-0072623-A1

 

13-Mar-2014

 

 

 

 

 

US

 

Depomed, Inc.

 

13/707961

 

07-Dec-2012

 

Granted

 

US 2013-0116320 A1

 

09-May-2013

 

8592481

 

26-Nov-2013

 

US

 

Depomed, Inc.

 

14/088058

 

22-Nov-2013

 

Abandoned

 

US-2014-0135395-A1

 

15-May-2014

 

 

 

 

 

US

 

Depomed, Inc.

 

14/328580

 

10-Jul-2014

 

Pending

 

 

 

 

 

 

 

 

 

AU

 

Depomed, Inc.

 

2002348828.00

 

25-Oct-2002

 

Granted

 

2002348828

 

20-Dec-2007

 

2002348828

 

03-Apr-2008

 

AU

 

Depomed, Inc.

 

2005267738.00

 

29-Jul-2005

 

Granted

 

 

 

 

 

2005267738

 

12-May-2011

 

AU

 

Depomed, Inc.

 

2006332690.00

 

29-Dec-2006

 

Abandoned

 

 

 

 

 

 

 

 

 

CA

 

Depomed, Inc.

 

2464322.00

 

25-Oct-2002

 

Granted

 

 

 

 

 

2464322

 

11-Oct-2011

 

CA

 

Depomed, Inc.

 

2575555.00

 

29-Jul-2005

 

Abandoned

 

 

 

 

 

 

 

 

 

CA

 

Depomed, Inc.

 

2635466.00

 

26-Jun-2008

 

Abandoned

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

200680053410.60

 

25-Aug-2008

 

Abandoned

 

CN 101484153

 

15-Jul-2009

 

 

 

 

 

DK

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

EPO

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Opposed

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

EPO

 

Depomed, Inc.

 

5777053.90

 

29-Jul-2005

 

Intnd Aband

 

1773311

 

18-Apr-2007

 

 

 

 

 

EPO

 

Depomed, Inc.

 

6848292.60

 

29-Dec-2006

 

Abandoned

 

1976503

 

08-Oct-2008

 

 

 

 

 

EPO

 

Depomed, Inc.

 

10179051.70

 

25-Oct-2002

 

Abandoned

 

2266539

 

29-Dec-2010

 

 

 

 

 

FI

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

FR

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

DE

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

IE

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

JP

 

Depomed, Inc.

 

2003-537607

 

25-Oct-2002

 

Granted

 

 

 

 

 

5421511

 

29-Nov-2013

 

JP

 

Depomed, Inc.

 

2007-523871

 

29-Jul-2005

 

Intnd Aband

 

2008-508317

 

21-Mar-2008

 

 

 

 

 

JP

 

Depomed, Inc.

 

2008-548754

 

29-Dec-2006

 

Intnd Aband

 

2009-522294

 

11-Jun-2009

 

 

 

 

 

JP

 

Depomed, Inc.

 

2010-179064

 

25-Oct-2002

 

Abandoned

 

2010-254713

 

11-Nov-2010

 

 

 

 

 

LU

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

MX

 

Depomed, Inc.

 

PA/A/2004/003946

 

25-Oct-2002

 

Granted

 

 

 

 

 

262974

 

10-Dec-2008

 

MX

 

Depomed, Inc.

 

PA/a/2007/001187

 

29-Jul-2005

 

Granted

 

 

 

 

 

283341

 

25-Jan-2011

 

MX

 

Depomed, Inc.

 

MX/a/2008/008504

 

27-Jun-2008

 

Abandoned

 

PA/a/2008/008504

 

29-Aug-2008

 

 

 

 

 

MC

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

NL

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

PCT

 

Depomed, Inc.

 

PCT/IB2002/005440

 

25-Oct-2002

 

NAT PHASE

 

WO 2003/035040

 

01-May-2003

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2005/027170

 

29-Jul-2005

 

NAT PHASE

 

WO 2006/015294

 

09-Feb-2006

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2006/049511

 

29-Dec-2006

 

NAT PHASE

 

WO 2007/079195

 

12-Jul-2007

 

 

 

 

 

SE

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

CH

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

TW

 

Depomed, Inc.

 

91124777.00

 

24-Oct-2002

 

Granted

 

 

 

 

 

I312285

 

21-Jul-2009

 

TW

 

Depomed, Inc.

 

95149757.00

 

29-Dec-2006

 

Intnd Aband

 

200800155

 

01-Jan-2008

 

 

 

 

 

UK

 

Depomed, Inc.

 

2781665.10

 

25-Oct-2002

 

Granted

 

1439825

 

28-Jul-2004

 

1439825

 

03-Apr-2013

 

US

 

Depomed, Inc.

 

10/280852

 

25-Oct-2002

 

Granted

 

 

 

 

 

7413751

 

19-Aug-2008

 

AU

 

Depomed, Inc.

 

2008282900.00

 

28-Jan-2010

 

Granted

 

 

 

 

 

2008282900

 

04-Sep-2014

 

CA

 

Depomed, Inc.

 

2694602.00

 

26-Jan-2010

 

Pending

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

200880100816.40

 

27-Jan-2010

 

Abandoned

 

101888828

 

17-Nov-2010

 

 

 

 

 

EPO

 

Depomed, Inc.

 

8794829.50

 

25-Jul-2008

 

Pending

 

2192892

 

09-Jun-2010

 

 

 

 

 

HK

 

Depomed, Inc.

 

11104785.80

 

16-May-2011

 

Abandoned

 

1150759A

 

13-Jan-2012

 

 

 

 

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

JP

 

Depomed, Inc.

 

2010-519222

 

27-Jan-2010

 

Abandoned

 

2010-534721

 

11-Nov-2010

 

 

 

 

 

MX

 

Depomed, Inc.

 

MX/a/2010/001071

 

27-Jan-2010

 

Abandoned

 

MX/a/2010/001071

 

01-Mar-2010

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2008/009139

 

25-Jul-2008

 

NAT PHASE

 

WO 2009/017716

 

05-Feb-2009

 

 

 

 

 

US

 

Depomed, Inc.

 

60/952501

 

27-Jul-2007

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

60/967717

 

05-Sep-2007

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

12/220747

 

25-Jul-2008

 

Pending

 

US-2009-0028941-A1

 

29-Jan-2009

 

 

 

 

 

AU

 

Depomed, Inc.

 

8138698.00

 

05-Jun-1998

 

Granted

 

 

 

 

 

729529

 

17-May-2001

 

AT

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

BE

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

CA

 

Depomed, Inc.

 

2290624.00

 

05-Jun-1998

 

Granted

 

 

 

 

 

2290624

 

05-Dec-2006

 

EPO

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

FR

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

DE

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

GR

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

3055266

 

24-Aug-2005

 

HK

 

Depomed, Inc.

 

106550.90

 

16-Oct-2000

 

Granted

 

1027298A

 

12-Jan-2001

 

1027298

 

09-Dec-2005

 

IE

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

IT

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

JP

 

Depomed, Inc.

 

11-502756

 

05-Jun-1998

 

Granted

 

 

 

 

 

4083818

 

22-Feb-2008

 

KR

 

Depomed, Inc.

 

1019997011439.00

 

05-Jun-1998

 

Granted

 

 

 

 

 

545480

 

17-Jan-2006

 

MX

 

Depomed, Inc.

 

9911232.00

 

05-Jun-1998

 

Granted

 

 

 

 

 

227488

 

27-Apr-2005

 

NL

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

PCT

 

Depomed, Inc.

 

PCT/US1998/011302

 

05-Jun-1998

 

NAT PHASE

 

1998/055107

 

10-Dec-1998

 

 

 

 

 

PT

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

ES

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

SE

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

CH

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

TW

 

Depomed, Inc.

 

 

 

 

 

Closed

 

 

 

 

 

 

 

 

 

UK

 

Depomed, Inc.

 

98931204.60

 

05-Jun-1998

 

Granted

 

 

 

 

 

998271

 

24-Aug-2005

 

US

 

Depomed, Inc.

 

08/870509

 

06-Jun-1997

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

09/282233

 

29-Mar-1999

 

Granted

 

 

 

 

 

6340475

 

22-Jan-2002

 

US

 

Depomed, Inc.

 

1870652.00

 

20-Nov-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

10/045823

 

06-Nov-2001

 

Granted

 

 

 

 

 

6635280

 

21-Oct-2003

 

CA

 

Depomed, Inc.

 

2364845.00

 

12-Dec-2001

 

Granted

 

 

 

 

 

2364845

 

20-Mar-2007

 

US

 

Depomed, Inc.

 

12/214264

 

16-Jun-2008

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

10/235076

 

04-Sep-2002

 

Granted

 

 

 

 

 

7405238

 

29-Jul-2008

 

US

 

Depomed, Inc.

 

10/623481

 

18-Jul-2003

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

13/530631

 

22-Jun-2012

 

Granted

 

US-2012-0263792-A1

 

18-Oct-2012

 

8685450

 

01-Apr-2014

 

US

 

Depomed, Inc.

 

14/199972

 

06-Mar-2014

 

Allowed

 

US-2014-0186515-A1

 

03-Jul-2014

 

 

 

 

 

US

 

Depomed, Inc.

 

14/642013

 

09-Mar-2015

 

Pending

 

 

 

 

 

 

 

 

 

TW

 

Depomed, Inc.

 

93121200.00

 

15-Jul-2004

 

Abandoned

 

 

 

 

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2004/022554

 

13-Jul-2004

 

NAT PHASE

 

2005/009413

 

03-Feb-2005

 

 

 

 

 

NZ

 

Depomed, Inc.

 

544615.00

 

13-Jul-2004

 

Abandoned

 

544615

 

27-Feb-2009

 

544615

 

11-Jun-2009

 

MX

 

Depomed, Inc.

 

PA/a/2006/00526

 

13-Jul-2004

 

Abandoned

 

 

 

 

 

 

 

 

 

KR

 

Depomed, Inc.

 

1020067001176.00

 

13-Jul-2004

 

Abandoned

 

 

 

 

 

 

 

 

 

JP

 

Depomed, Inc.

 

2006-520295

 

13-Jul-2004

 

Abandoned

 

2007-524644

 

30-Aug-2007

 

 

 

 

 

EPO

 

Depomed, Inc.

 

4778191.90

 

13-Jul-2004

 

Abandoned

 

1646368

 

19-Apr-2006

 

 

 

 

 

CA

 

Depomed, Inc.

 

2531721.00

 

06-Jan-2006

 

Granted

 

 

 

 

 

2531721

 

11-Jun-2013

 

AU

 

Depomed, Inc.

 

2004258903.00

 

13-Jul-2004

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

09/425491

 

22-Oct-1999

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

08/716906

 

19-Sep-1996

 

Granted

 

 

 

 

 

5972389

 

26-Oct-1999

 

UK

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

CH

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

ES

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

PT

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

PCT

 

Depomed, Inc.

 

PCT/US1997/016725

 

18-Sep-1997

 

NAT PHASE

 

1998/11879

 

26-Mar-1998

 

 

 

 

 

NO

 

Depomed, Inc.

 

19991341.00

 

18-Sep-1997

 

Abandoned

 

 

 

 

 

 

 

 

 

NL

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

KR

 

Depomed, Inc.

 

1019997002390.00

 

18-Sep-1997

 

Granted

 

200048500

 

25-Jul-2000

 

10-0685303

 

14-Feb-2007

 

JP

 

Depomed, Inc.

 

10514926.00

 

18-Sep-1997

 

Abandoned

 

 

 

 

 

 

 

 

 

IT

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

IE

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

DE

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

FR

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

EPO

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

EPO

 

Depomed, Inc.

 

3027586.10

 

18-Sep-1997

 

Abandoned

 

 

 

 

 

1424069

 

08-Sep-2004

 

CA

 

Depomed, Inc.

 

2266589.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

2266589

 

03-Jan-2006

 

BE

 

Depomed, Inc.

 

97942616.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

941071

 

07-Jan-2004

 

AU

 

Depomed, Inc.

 

4428097.00

 

18-Sep-1997

 

Granted

 

 

 

 

 

741760

 

21-Mar-2002

 

US

 

Depomed, Inc.

 

09/498945

 

04-Feb-2000

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

12/770283

 

29-Apr-2010

 

Granted

 

US-2010-0272808-A1

 

28-Oct-2010

 

8043630

 

25-Oct-2011

 

US

 

Depomed, Inc.

 

13/156225

 

08-Jun-2011

 

Granted

 

US-2011-0236485-A1

 

29-Sep-2011

 

8329215

 

11-Dec-2012

 

US

 

Depomed, Inc.

 

13/688114

 

28-Nov-2012

 

Granted

 

US 2013-0164377 A1

 

27-Jun-2013

 

8945619

 

03-Feb-2015

 

US

 

Depomed, Inc.

 

10/213823

 

07-Aug-2002

 

Granted

 

 

 

 

 

7736667

 

15-Jun-2010

 

US

 

Depomed, Inc.

 

14/584805

 

29-Dec-2014

 

Pending

 

 

 

 

 

 

 

 

 

UK

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

AU

 

Depomed, Inc.

 

3466101.00

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

767812

 

11-Mar-2004

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

BE

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

CA

 

Depomed, Inc.

 

2396782.00

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

EPO

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

FR

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

DE

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

HK

 

Depomed, Inc.

 

3102713.90

 

15-Apr-2003

 

Abandoned

 

 

 

 

 

1050493

 

01-Dec-2006

 

IE

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

IL

 

Depomed, Inc.

 

150568.00

 

30-Jan-2001

 

Granted

 

 

 

 

 

150568

 

04-Mar-2008

 

IT

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

JP

 

Depomed, Inc.

 

2001556236.00

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

MX

 

Depomed, Inc.

 

PA/a/2002/007254

 

30-Jan-2001

 

Granted

 

 

 

 

 

241836

 

08-Nov-2006

 

NL

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

NZ

 

Depomed, Inc.

 

519921.00

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

519921

 

29-Mar-2004

 

PCT

 

Depomed, Inc.

 

PCT/US2001/003027

 

30-Jan-2001

 

NAT PHASE

 

2001/056544

 

09-Aug-2001

 

 

 

 

 

PT

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

ES

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

SE

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

CH

 

Depomed, Inc.

 

1906794.10

 

30-Jan-2001

 

Abandoned

 

 

 

 

 

1251832

 

27-Sep-2006

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

AU

 

Depomed, Inc.

 

2001239893.00

 

26-Feb-2001

 

Abandoned

 

 

 

 

 

2001239893

 

03-Mar-2005

 

BE

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

CA

 

Depomed, Inc.

 

2412671.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

2412671

 

03-Oct-2006

 

DK

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

EPO

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

FR

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

DE

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

IE

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

IL

 

Depomed, Inc.

 

153464.00

 

26-Feb-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

IT

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

JP

 

Depomed, Inc.

 

2002-503260

 

20-Dec-2002

 

Abandoned

 

 

 

 

 

 

 

 

 

JP

 

Depomed, Inc.

 

2008-213240

 

26-Feb-2001

 

Abandoned

 

2009-040787

 

26-Feb-2009

 

 

 

 

 

JP

 

Depomed, Inc.

 

2013-142872

 

08-Jul-2013

 

Pending

 

2013-224324

 

31-Oct-2013

 

 

 

 

 

KR

 

Depomed, Inc.

 

10-2002-7017415

 

26-Feb-2001

 

Granted

 

 

 

 

 

10-0716756

 

14-May-2007

 

MX

 

Depomed, Inc.

 

PA/a/2002/012614

 

26-Feb-2001

 

Granted

 

 

 

 

 

245737

 

09-May-2007

 

NL

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

NZ

 

Depomed, Inc.

 

523214.00

 

26-Feb-2001

 

Abandoned

 

 

 

 

 

523214

 

08-Dec-2003

 

PCT

 

Depomed, Inc.

 

PCT/US2001/006164

 

26-Feb-2001

 

NAT PHASE

 

2001/97783

 

27-Dec-2001

 

 

 

 

 

PT

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

ES

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

SE

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

CH

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

UK

 

Depomed, Inc.

 

1914515.00

 

26-Feb-2001

 

Granted

 

 

 

 

 

1294363

 

17-Dec-2003

 

US

 

Depomed, Inc.

 

2314787.00

 

20-Jun-2000

 

Granted

 

 

 

 

 

6488962

 

03-Dec-2002

 

AU

 

Depomed, Inc.

 

2002211923.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

2002211923

 

16-Mar-2006

 

CA

 

Depomed, Inc.

 

2422711.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

2422711

 

07-Jul-2009

 

EPO

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Granted

 

 

 

 

 

1326643

 

28-Dec-2005

 

FR

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

DE

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

60116353.2

 

28-Dec-2005

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

IL

 

Depomed, Inc.

 

154988.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

IT

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

JP

 

Depomed, Inc.

 

2002535654.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

 

 

 

 

KR

 

Depomed, Inc.

 

1020037005263.00

 

16-Oct-2001

 

Granted

 

 

 

 

 

10-0907640

 

14-Jul-2009

 

MX

 

Depomed, Inc.

 

PA/a/2003/003128

 

16-Oct-2001

 

Granted

 

 

 

 

 

232349

 

23-Nov-2005

 

NZ

 

Depomed, Inc.

 

524790.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

524790

 

06-Mar-2006

 

PCT

 

Depomed, Inc.

 

PCT/US2001/042751

 

16-Oct-2001

 

NAT PHASE

 

2002/032416

 

25-Apr-2002

 

 

 

 

 

PT

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

ES

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

CH

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

UK

 

Depomed, Inc.

 

1980020.00

 

16-Oct-2001

 

Abandoned

 

 

 

 

 

1326643

 

28-Dec-2005

 

US

 

Depomed, Inc.

 

09/691398

 

17-Oct-2000

 

Granted

 

 

 

 

 

6451808

 

17-Sep-2002

 

AU

 

Depomed, Inc.

 

2002337974.00

 

22-Oct-2002

 

Granted

 

 

 

 

 

2002337974

 

01-Jun-2006

 

CA

 

Depomed, Inc.

 

2409999.00

 

24-Oct-2002

 

Granted

 

 

 

 

 

2409999

 

04-Sep-2007

 

EPO

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

EPO

 

Depomed, Inc.

 

10178869.30

 

22-Oct-2002

 

Abandoned

 

2260832

 

15-Dec-2010

 

 

 

 

 

FR

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

DE

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

IE

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

JP

 

Depomed, Inc.

 

2003-537738

 

22-Oct-2002

 

Granted

 

2005-532985

 

04-Nov-2005

 

5133495

 

16-Nov-2012

 

JP

 

Depomed, Inc.

 

2012-196459

 

06-Sep-2012

 

Abandoned

 

 

 

 

 

 

 

 

 

LU

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

MX

 

Depomed, Inc.

 

PA/a/2004/003793

 

22-Oct-2002

 

Granted

 

 

 

 

 

241834

 

08-Nov-2006

 

MC

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

NZ

 

Depomed, Inc.

 

532536.00

 

22-Oct-2002

 

Abandoned

 

 

 

 

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2002/033968

 

22-Oct-2002

 

NAT PHASE

 

2003/035177

 

01-May-2003

 

 

 

 

 

CH

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

TW

 

Depomed, Inc.

 

91124778.00

 

24-Oct-2002

 

Granted

 

 

 

 

 

I325326

 

01-Jun-2010

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

UK

 

Depomed, Inc.

 

2773879.80

 

22-Oct-2002

 

Granted

 

1446106

 

18-Aug-2004

 

1446106

 

14-Dec-2011

 

US

 

Depomed, Inc.

 

 

 

 

 

Closed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

10/029134

 

25-Oct-2001

 

Granted

 

US2003-0104053A1

 

05-Jun-2003

 

6723340

 

20-Apr-2004

 

AU

 

Depomed, Inc.

 

2003207755.00

 

28-Jan-2003

 

Abandoned

 

 

 

 

 

2003207755

 

25-Jan-2007

 

CA

 

Depomed, Inc.

 

2417686.00

 

28-Jan-2003

 

Abandoned

 

 

 

 

 

2417686

 

06-Jun-2006

 

EPO

 

Depomed, Inc.

 

3705993.80

 

28-Jan-2003

 

Abandoned

 

1469838

 

27-Oct-2004

 

 

 

 

 

HK

 

Depomed, Inc.

 

4110096.80

 

21-Dec-2004

 

Abandoned

 

1067050A

 

01-Apr-2005

 

 

 

 

 

IL

 

Depomed, Inc.

 

163205.00

 

28-Jan-2003

 

Granted

 

 

 

 

 

163205

 

21-Oct-2009

 

JP

 

Depomed, Inc.

 

2003565452.00

 

28-Jan-2003

 

Abandoned

 

 

 

 

 

 

 

 

 

KR

 

Depomed, Inc.

 

10-2004-7011934

 

28-Jan-2003

 

Granted

 

 

 

 

 

10-0680574

 

02-Feb-2007

 

MX

 

Depomed, Inc.

 

PA/a/2004/007371

 

28-Jan-2003

 

Granted

 

 

 

 

 

243248

 

10-Jan-2007

 

NZ

 

Depomed, Inc.

 

534312.00

 

28-Jan-2003

 

Granted

 

 

 

 

 

534312

 

08-Jun-2006

 

PCT

 

Depomed, Inc.

 

PCT/US2003/002809

 

28-Jan-2003

 

NAT PHASE

 

2003/066028

 

29-Aug-2003

 

 

 

 

 

TW

 

Depomed, Inc.

 

92102293.00

 

20-Jan-2003

 

Granted

 

 

 

 

 

I280141

 

01-May-2007

 

US

 

Depomed, Inc.

 

-470888.00

 

01-Feb-2002

 

Granted

 

 

 

 

 

6682759

 

27-Jan-2004

 

AU

 

Depomed, Inc.

 

2009223061.00

 

11-Mar-2009

 

Granted

 

 

 

 

 

2009223061

 

22-Jan-2015

 

CA

 

Depomed, Inc.

 

2720108.00

 

30-Sep-2010

 

Pending

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

200980116247.70

 

05-Nov-2010

 

Granted

 

102105136

 

22-Jun-2011

 

ZL200980116247.7

 

26-Nov-2014

 

EPO

 

Depomed, Inc.

 

9720928.20

 

11-Mar-2009

 

Granted

 

2262484

 

22-Dec-2010

 

2262484

 

23-Jan-2013

 

FR

 

Depomed, Inc.

 

9720928.20

 

11-Mar-2009

 

Granted

 

2262484

 

22-Dec-2010

 

2262484

 

23-Jan-2013

 

DE

 

Depomed, Inc.

 

9720928.20

 

11-Mar-2009

 

Granted

 

2262484

 

22-Dec-2010

 

2262484

 

23-Jan-2013

 

HK

 

Depomed, Inc.

 

11105856.90

 

09-Jun-2011

 

Granted

 

1152469A

 

02-Mar-2012

 

HK1152469

 

19-Sep-2013

 

JP

 

Depomed, Inc.

 

2010-550846

 

11-Mar-2009

 

Granted

 

2011-513499

 

28-Apr-2011

 

5607550

 

05-Sep-2014

 

MX

 

Depomed, Inc.

 

MX/a/2010/009990

 

11-Mar-2009

 

Granted

 

 

 

 

 

306299

 

18-Dec-2012

 

PCT

 

Depomed, Inc.

 

PCT/US2009/036864

 

11-Mar-2009

 

NAT PHASE

 

WO 2009/114648

 

17-Sep-2009

 

 

 

 

 

UK

 

Depomed, Inc.

 

9720928.20

 

11-Mar-2009

 

Granted

 

2262484

 

22-Dec-2010

 

2262484

 

23-Jan-2013

 

US

 

Depomed, Inc.

 

61/035696

 

11-Mar-2008

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

2688887.00

 

11-Mar-2009

 

Granted

 

US-2010-0015222-A1

 

21-Jan-2010

 

8377453

 

19-Feb-2013

 

US

 

Depomed, Inc.

 

12/644444

 

22-Dec-2009

 

Granted

 

US-2010-0196474-A1

 

05-Aug-2010

 

8372432

 

12-Feb-2013

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Depomed, Inc.

 

13/360595

 

27-Jan-2012

 

Granted

 

US2012-0136022A1

 

31-May-2012

 

8394408

 

12-Mar-2013

 

US

 

Depomed, Inc.

 

13/529960

 

21-Jun-2012

 

Granted

 

US-2012-0321713-A1

 

20-Dec-2012

 

8668929

 

11-Mar-2014

 

US

 

Depomed, Inc.

 

 

 

 

 

Closed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

14/196143

 

04-Mar-2014

 

Pending

 

US-2014-0186440-A1

 

03-Jul-2014

 

 

 

 

 

AU

 

Depomed, Inc.

 

2009281752.00

 

14-Aug-2009

 

Pending

 

 

 

 

 

 

 

 

 

BR

 

Depomed, Inc.

 

14671.00

 

15-Feb-2011

 

Pending

 

 

 

 

 

 

 

 

 

CA

 

Depomed, Inc.

 

2733787.00

 

10-Feb-2011

 

Pending

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

200980141342.20

 

14-Aug-2011

 

Pending

 

102202656

 

28-Sep-2011

 

 

 

 

 

EPO

 

Depomed, Inc.

 

9791546.60

 

10-Mar-2011

 

Pending

 

2326310

 

01-Jun-2011

 

 

 

 

 

HK

 

Depomed, Inc.

 

11112402.40

 

17-Nov-2011

 

Pending

 

1158064A

 

13-Jul-2012

 

 

 

 

 

JP

 

Depomed, Inc.

 

2011-523207

 

15-Feb-2011

 

Abandoned

 

2012-500221

 

05-Jan-2012

 

 

 

 

 

KR

 

Depomed, Inc.

 

10-2011-7005446

 

08-Mar-2011

 

Pending

 

 

 

 

 

 

 

 

 

MX

 

Depomed, Inc.

 

MX/a/2011/001639

 

11-Feb-2011

 

Pending

 

 

 

 

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2009/053937

 

14-Aug-2009

 

NAT PHASE

 

WO 2010/019915

 

18-Feb-2010

 

 

 

 

 

US

 

Depomed, Inc.

 

61/089339

 

15-Aug-2008

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

61/122276

 

12-Dec-2008

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

12/541836

 

14-Aug-2009

 

Pending

 

US-2010-0040689-A1

 

18-Feb-2010

 

 

 

 

 

AU

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

CA

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

EPO

 

Depomed, Inc.

 

9709706.70

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

IL

 

Depomed, Inc.

 

207508.00

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

JP

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

KR

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

MX

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

NZ

 

Depomed, Inc.

 

 

 

10-Feb-2009

 

Abandoned

 

 

 

 

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2009/033702

 

10-Feb-2009

 

NAT PHASE

 

WO 2009/102734

 

20-Aug-2009

 

 

 

 

 

US

 

Depomed, Inc.

 

12/368907

 

10-Feb-2009

 

Granted

 

US-2009-0209645-A1

 

20-Aug-2009

 

8329750

 

11-Dec-2012

 

US

 

Depomed, Inc.

 

13/686865

 

27-Nov-2012

 

Abandoned

 

US-2013-0158121-A1

 

20-Jun-2013

 

 

 

 

 

AU

 

Depomed, Inc.

 

2010286354.00

 

31-Aug-2010

 

Pending

 

 

 

 

 

 

 

 

 

BR

 

Depomed, Inc.

 

1120120045253.00

 

31-Aug-2010

 

Pending

 

 

 

 

 

 

 

 

 

CN

 

Depomed, Inc.

 

201080049502.30

 

31-Aug-2010

 

Abandoned

 

102596252

 

18-Jul-2012

 

 

 

 

 

EPO

 

Depomed, Inc.

 

10812767.10

 

31-Aug-2010

 

Abandoned

 

2473195

 

11-Jul-2012

 

 

 

 

 

IN

 

Depomed, Inc.

 

2748/CHENP/2012

 

31-Aug-2010

 

Pending

 

2748/CHENP/2012 A

 

10-May-2013

 

 

 

 

 

IL

 

Depomed, Inc.

 

218370.00

 

28-Feb-2012

 

Pending

 

 

 

 

 

 

 

 

 

KR

 

Depomed, Inc.

 

10-2012-7007703

 

26-Mar-2012

 

Pending

 

 

 

 

 

 

 

 

 

NZ

 

Depomed, Inc.

 

598922.00

 

21-Mar-2012

 

Granted

 

 

 

 

 

598922

 

01-Jul-2014

 

PCT

 

Depomed, Inc.

 

PCT/US2010/047369

 

31-Aug-2010

 

NAT PHASE

 

WO 2011/026125

 

03-Mar-2011

 

 

 

 

 

PL

 

Depomed, Inc.

 

P.399450

 

29-Feb-2012

 

Pending

 

 

 

 

 

 

 

 

 

RU

 

Depomed, Inc.

 

2012112552.00

 

30-Mar-2012

 

Abandoned

 

 

 

10-Oct-2013

 

 

 

 

 

ZA

 

Depomed, Inc.

 

2012/02061

 

31-Aug-2010

 

Granted

 

 

 

 

 

2012/02061

 

29-May-2013

 

US

 

Depomed, Inc.

 

61/238374

 

31-Aug-2009

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

12/872723

 

31-Aug-2010

 

Pending

 

US-2011-0052685-A1

 

03-Mar-2011

 

 

 

 

 

CA

 

Depomed, Inc.

 

2783342.00

 

07-Jun-2012

 

Pending

 

 

 

 

 

 

 

 

 

EPO

 

Depomed, Inc.

 

10836650.10

 

08-Dec-2010

 

Abandoned

 

2509635

 

17-Oct-2012

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2010/059561

 

08-Dec-2010

 

NAT PHASE

 

WO 2011/072069

 

16-Jun-2011

 

 

 

 

 

US

 

Depomed, Inc.

 

12/963520

 

08-Dec-2010

 

Abandoned

 

US2011-0135728A1

 

09-Jun-2011

 

 

 

 

 

US

 

Depomed, Inc.

 

61/267669

 

08-Dec-2009

 

Completed

 

 

 

 

 

 

 

 

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

CA

 

Depomed, Inc.

 

2850468.00

 

28-Mar-2014

 

Pending

 

 

 

 

 

 

 

 

 

EPO

 

Depomed, Inc.

 

11833073.70

 

25-Apr-2013

 

Pending

 

2621487

 

07-Aug-2013

 

 

 

 

 

MX

 

Depomed, Inc.

 

MX/a/2013/003556

 

28-Sep-2011

 

Pending

 

 

 

 

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/US2011/053769

 

28-Sep-2011

 

NAT PHASE

 

WO 2012/050922

 

19-Apr-2012

 

 

 

 

 

US

 

Depomed, Inc.

 

13/247956

 

28-Sep-2011

 

Allowed

 

US-2012-0077878-A1

 

29-Mar-2012

 

 

 

 

 

US

 

Depomed, Inc.

 

14/632959

 

26-Feb-2015

 

Pending

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

13/622511

 

19-Sep-2012

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

14/340499

 

24-Jul-2014

 

Pending

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

61/650451

 

22-May-2012

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

13/900312

 

22-May-2013

 

Pending

 

US 2013-0316002-A1

 

28-Nov-2013

 

 

 

 

 

US

 

Depomed, Inc.

 

60/071865

 

20-Jan-1998

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

09/232354

 

15-Jan-1999

 

Granted

 

 

 

 

 

6287594

 

11-Sep-2001

 

US

 

Depomed, Inc.

 

09/354982

 

16-Jul-1999

 

Granted

 

 

 

 

 

6365180

 

02-Apr-2002

 

US

 

Depomed, Inc.

 

61/055581

 

23-May-2008

 

Completed

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

12/391,434

 

24-Feb-2009

 

Granted

 

US2009-0292022A1

 

26-Nov-2009

 

7662858

 

16-Feb-2010

 

US

 

Depomed, Inc.

 

2132987.00

 

15-May-2009

 

Granted

 

US-2009-0292023-A1

 

26-Nov-2009

 

7939518

 

10-May-2011

 

US

 

Depomed, Inc.

 

12/706117

 

16-Feb-2010

 

Granted

 

US-2010-0144882-A1

 

10-Jun-2010

 

8110606

 

07-Feb-2012

 

US

 

Depomed, Inc.

 

12/772858

 

03-May-2010

 

Granted

 

US-2010-0222430-A1

 

02-Sep-2010

 

7884095

 

08-Feb-2011

 

US

 

Depomed, Inc.

 

13/205033

 

08-Aug-2011

 

Granted

 

US-2011-0300207-A1

 

08-Dec-2011

 

8623920

 

07-Jan-2014

 

US

 

Depomed, Inc.

 

14/137605

 

20-Dec-2013

 

Pending

 

US-2014-0107210-A1

 

17-Apr-2014

 

 

 

 

 

PCT

 

Depomed, Inc.

 

PCT/GB1998/001147

 

20-Apr-1998

 

NAT PHASE

 

WO/1998/047535

 

29-Oct-1998

 

 

 

 

 

US

 

Depomed, Inc.

 

2871052.00

 

20-Jan-2000

 

Granted

 

 

 

 

 

6432440

 

13-Aug-2002

 

US

 

Depomed, Inc.

 

30225.00

 

15-Jul-2002

 

Abandoned

 

US 2002-0197324 A1

 

26-Dec-2002

 

 

 

 

 

US

 

Depomed, Inc.

 

11/562002

 

21-Nov-2006

 

Abandoned

 

US 2007-0110677 A1

 

17-May-2007

 

 

 

 

 

US

 

Depomed, Inc.

 

11/562173

 

21-Nov-2006

 

Abandoned

 

US 2007-0092535 A1

 

26-Apr-2007

 

 

 

 

 

US

 

Depomed, Inc.

 

13/078575

 

01-Apr-2011

 

Abandoned

 

US 2011-0182857 A1

 

28-Jul-2011

 

 

 

 

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Depomed, Inc.

 

10/753628

 

08-Jan-2004

 

Abandoned

 

US 2004-0166067 A1

 

26-Aug-2004

 

 

 

 

 

US

 

Depomed, Inc.

 

12/047388

 

13-Mar-2008

 

Granted

 

US 2008-0153879 A1

 

26-Jun-2008

 

8216604

 

10-Jul-2012

 

US

 

Depomed, Inc.

 

13/541314

 

03-Jul-2012

 

Granted

 

US 2012-0277267 A1

 

01-Nov-2012

 

8889176

 

18-Nov-2014

 

US

 

Depomed, Inc.

 

13/541325

 

03-Jul-2012

 

Pending

 

US 2012-0270903 A1

 

25-Oct-2012

 

 

 

 

 

US

 

Depomed, Inc.

 

62/063311

 

13-Oct-2014

 

Pending

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

62/092487

 

16-Dec-2014

 

Pending

 

 

 

 

 

 

 

 

 

US

 

Depomed, Inc.

 

08/453144

 

30-May-1995

 

Granted

 

 

 

 

 

5582837

 

10-Dec-1996

 

US

 

Depomed, Inc.

 

14/012,484

 

28-Aug-2013

 

Pending

 

2014-0066411

 

6-Mar-2014

 

 

 

 

 

 

LICENSED PATENTS

 

Depomed, Inc.

 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Archemides Development Limited

 

13/122332

 

6/27/2011

 

Pending

 

2011/0257632

 

10/20/2011

 

 

 

 

 

US

 

Archemides Development Limited

 

13/147,746

 

2/4/2010

 

Granted

 

2012/0055929

 

3/8/2012

 

8915393

 

12/23/2014

 

US

 

Archemides Development Limited

 

29/352864

 

12/29/2009

 

Granted

 

 

 

 

 

D663943

 

7/24/2012

 

CA

 

Archemides Development Limited

 

133458

 

12/23/2009

 

Granted

 

133458

 

 

 

133458

 

7/29/2010

 

US

 

Archemides Development Limited

 

13/196061

 

2/2/2012

 

Pending

 

2012/0024724

 

2/2/2012

 

 

 

 

 

US

 

Archemides Development Limited

 

13/983,400

 

1/26/2012

 

Pending

 

2013/0313287

 

11/28/2013

 

 

 

 

 

CA

 

Archemides Development Limited

 

2824385

 

1/26/2012

 

Pending

 

2824385

 

 

 

 

 

 

 

CA

 

Archemides Development Limited

 

141646

 

8/3/2011

 

Granted

 

 

 

 

 

141646

 

4/26/2012

 

US

 

Takeda Pharma A/S

 

10/343449

 

7/31/2001

 

Granted

 

2004/0034059

 

3/19/2004

 

8017627

 

9/13/2011

 

US

 

Takeda Pharma A/S

 

11/656970

 

1/24/2007

 

Granted

 

2007/0134164

 

6/14/2007

 

8158651

 

4/17/2012

 

US

 

Takeda Pharma A/S

 

13/188862

 

1/22/2011

 

Granted

 

2011/0291914

 

11/17/2011

 

8653107

 

2/18/2014

 

CA

 

APR Applied Pharma Research SA

 

2417737

 

7/13/2004

 

Granted

 

 

 

 

 

2417727

 

9/1/2009

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

APR Applied Pharma Research SA

 

09/192493

 

11/17/1995

 

Abandoned

 

 

 

 

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

09/524,747

 

3/14/2000

 

Granted

 

 

 

 

 

6794595

 

12/13/2005

 

US

 

APR Applied Pharma Research SA

 

11/030537

 

1/5/2005

 

Abandoned

 

2005/0147671

 

7/7/2005

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

13/481478

 

5/25/2012

 

Pending

 

2013/0142874

 

6/6/2013

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

11/132023

 

5/18/2005

 

Abandoned

 

2005/0215643

 

9/29/2005

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

11/132024

 

5/18/2005

 

Granted

 

2005/0214363

 

9/29/2005

 

7482377

 

1/27/2006

 

US

 

APR Applied Pharma Research SA

 

11/180996

 

7/13/2005

 

Abandoned

 

2006/0013896

 

1/19/2006

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

11/351611

 

2/10/2006

 

Granted

 

2006/0188565

 

8/24/2006

 

7687542

 

3/30/2010

 

CA

 

APR Applied Pharma Research SA

 

2254144

 

5/15/1997

 

Granted

 

 

 

 

 

2254144

 

11/20/2007

 

US

 

APR Applied Pharma Research SA

 

11/455120

 

6/16/2006

 

Granted

 

2007/0015831

 

1/18/2007

 

7759394

 

7/20/2010

 

US

 

APR Applied Pharma Research SA

 

12/399175

 

3/6/2009

 

Abandoned

 

2009/0197961

 

8/6/2009

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

12/683517

 

1/7/2010

 

Granted

 

2010/0204330

 

8/12/2010

 

8097651

 

1/17/2012

 

US

 

APR Applied Pharma Research SA

 

13/742871

 

1/16/2013

 

Granted

 

2013/0245122

 

9/19/2013

 

8927604

 

1/6/2015

 

US

 

APR Applied Pharma Research SA

 

14/534428

 

11/6/2014

 

Published

 

2015/0064258

 

3/5/2015

 

 

 

 

 

CA

 

APR Applied Pharma Research SA

 

2632375

 

6/16/2006

 

Pending

 

 

 

 

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

11/348634

 

2/7/2006

 

Granted

 

2007/0184106

 

8/9/2007

 

7939561

 

5/10/2011

 

US

 

APR Applied Pharma Research SA

 

60/795,214

 

4/25/2006

 

Expired

 

 

 

 

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

12/298550

 

4/1/2009

 

Abandoned

 

2010/0016363

 

1/21/2010

 

 

 

 

 

CA

 

APR Applied Pharma Research SA

 

2661819

 

4/25/2007

 

Granted

 

 

 

 

 

2661819

 

7/29/2014

 

US

 

APR Applied Pharma Research SA

 

11/349008

 

2/7/2006

 

Granted

 

2007/0184107

 

8/9/2007

 

7700125

 

4/20/2010

 

US

 

APR Applied Pharma Research SA

 

12/555975

 

9/9/2009

 

Granted

 

2011/0105613

 

5/5/2011

 

8097267

 

1/17/2012

 

US

 

APR Applied Pharma Research SA

 

13/331324

 

12/20/2011

 

Abandoned

 

2012/0208886

 

8/16/2012

 

 

 

 

 

US

 

APR Applied Pharma Research SA

 

13/769508

 

2/18/2013

 

Abandoned

 

2013/0267602

 

10/10/2013

 

 

 

 

 

US

 

Valeant International

 

14/262622

 

25-Apr-2014

 

Published

 

20150030675

 

29-Jan-2015

 

 

 

 

 

US

 

Grunenthal GmbH

 

09/838,192

 

06 Jun 1995

 

 

 

20020010178

 

 

 

6344558

 

05 Feb 2002

 

US

 

Grunenthal GmbH

 

08/466,911

 

06 Jun 1995

 

 

 

 

 

 

 

6248737

 

19 Jun 2001

 

US

 

Grunenthal GmbH

 

10/462,844

 

17 Jun 2003

 

 

 

 

 

 

 

RE39593

 

19 Jun 2001

 

US

 

Grunenthal GmbH

 

13/868,635

 

22 Oct 2002

 

 

 

20130237608

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/850,208

 

11 Mar 2008

 

 

 

20100311842

 

 

 

8536130

 

17 Sep 2013

 

US

 

Grunenthal GmbH

 

12/634,777

 

27 Jun 2005

 

 

 

20100160447

 

 

 

7994364

 

09 Aug 2011

 

US

 

Grunenthal GmbH

 

14/304,313

 

13 Jun 2014

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

11/133,190

 

18 Nov 2003

 

 

 

20050277687

 

 

 

7786160

 

31 Aug 2010

 

US

 

Grunenthal GmbH

 

12/834,641

 

18 Nov 2003

 

 

 

20100280017

 

 

 

8420691

 

16 Apr 2013

 

US

 

Grunenthal GmbH

 

13/717,977

 

18 Nov 2003

 

 

 

20130109733

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

11/774,816

 

18 Nov 2003

 

 

 

20070249724

 

 

 

8003701

 

23 Aug 2011

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Grunenthal GmbH

 

12/834,655

 

18 Nov 2003

 

 

 

20100280129

 

 

 

8618177

 

31 Dec 2013

 

US

 

Grunenthal GmbH

 

12/834,664

 

18 Nov 2003

 

 

 

20100280126

 

 

 

8404749

 

26 Mar 2013

 

Europe

 

Grunenthal GmbH

 

PCT/EP03/12882

 

18 Nov 2003

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/667,110

 

21 Jun 2004

 

 

 

20130060065

 

 

 

8704002

 

22 Apr 2014

 

US

 

Grunenthal GmbH

 

11/294,449

 

04 Jun 2004

 

 

 

20060194988

 

 

 

7417170

 

26 Aug 2008

 

US

 

Grunenthal GmbH

 

13/972,253

 

14 Jun 2011

 

 

 

20130338399

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/160,050

 

14 Jun 2011

 

 

 

20110306793

 

 

 

8669399

 

11 Mar 2014

 

US

 

Grunenthal GmbH

 

12/113,582

 

30 Oct 2006

 

 

 

20090043132

 

 

 

8791300

 

29 Jul 2014

 

US

 

Grunenthal GmbH

 

11/915,653

 

29 May 2006

 

 

 

20080269524

 

 

 

7649114

 

19 Jan 2010

 

US

 

Grunenthal GmbH

 

14/478797

 

05 Sep 2014

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/374,874

 

23 Jul 2007

 

 

 

20100099916

 

 

 

8877974

 

04 Nov 2014

 

US

 

Grunenthal GmbH

 

13/754,528

 

27 Apr 2007

 

 

 

20130190333

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

11/741,420

 

27 Apr 2007

 

 

 

20070254960

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/374,910

 

23 Jul 2007

 

 

 

20090326271

 

 

 

8263809

 

11 Sep 2012

 

US

 

Grunenthal GmbH

 

12/106,695

 

21 Apr 2008

 

 

 

20090012180

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/329,111

 

05 Dec 2008

 

 

 

20090149534

 

 

 

8134032

 

13 Mar 2012

 

US

 

Grunenthal GmbH

 

12/768,232

 

27 Apr 2010

 

 

 

20100280128

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/438,410

 

03 Apr 2012

 

 

 

20120309840

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/188,689

 

22 Jul 2011

 

 

 

20120022117

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/410,768

 

02 Mar 2012

 

 

 

20130022670

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/410,945

 

02 Mar 2012

 

 

 

20120225951

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/410,837

 

02 Mar 2012

 

 

 

20120225950

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/438,469

 

03 Apr 2012

 

 

 

20120309841

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

61/671,975

 

16 Jul 2012

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

61/673,948

 

20 Jul 2012

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

10/718,112

 

20 Nov 2003

 

 

 

20050031546

 

 

 

8114383

 

14 Feb 2012

 

US

 

Grunenthal GmbH

 

13/346,257

 

20 Nov 2003

 

 

 

20120107250

 

 

 

8309060

 

13 Nov 2012

 

US

 

Grunenthal GmbH

 

11/349,544

 

06 Feb 2006

 

 

 

20070183979

 

 

 

8075872

 

13 Dec 2011

 

US

 

Grunenthal GmbH

 

13/270,505

 

06 Feb 2006

 

 

 

20120034171

 

 

 

8420056

 

16 Apr 2013

 

US

 

Grunenthal GmbH

 

10/890,704

 

14 Jul 2004

 

 

 

20060002859

 

 

 

8114384

 

14 Feb 2012

 

US

 

Grunenthal GmbH

 

12/358,415

 

23 Jan 2009

 

 

 

20090202634

 

 

 

8383152

 

26 Feb 2013

 

US

 

Grunenthal GmbH

 

14/138,372

 

03 Aug 2006

 

 

 

20140170079

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/138,323

 

20 Nov 2003

 

 

 

20140105830

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

11/462,216

 

03 Aug 2006

 

 

 

20070048228

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/087,017

 

05 Aug 2004

 

 

 

20140080915

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/458,526

 

13 Aug 2014

 

 

 

 

 

 

 

 

 

 

 

 

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

 



 

Country

 

Assignee

 

Application No.

 

Filing Date

 

Status

 

Publication No.

 

Publication Date

 

Patent No.

 

Issue Date

 

US

 

Grunenthal GmbH

 

11/471,438

 

23 Dec 2004

 

 

 

20070003616

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/174,876

 

14 Jul 2004

 

 

 

20140155489

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/897,746

 

14 Jul 2004

 

 

 

20130251643

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/508,262

 

07 Oct 2014

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

11/348,276

 

06 Feb 2006

 

 

 

20060188447

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/564,188

 

09 Dec 2014

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/261,625

 

25 Apr 2014

 

 

 

20140322323

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/840,439

 

20 Jul 2010

 

 

 

20110038930

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

12/916,988

 

08 May 2009

 

 

 

20110082214

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/018,629

 

01 Feb 2011

 

 

 

20110187017

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

13/962098

 

8 Aug 2013

 

 

 

 

 

 

 

 

 

 

 

US

 

Grunenthal GmbH

 

14/580578

 

23 Dec 2014

 

 

 

 

 

 

 

 

 

 

 

 

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

 



 

ANNEX F

 

TRADEMARKS AND TRADEMARK APPLICATIONS

 

MARK

 

COUNTRY

 

OWNER

 

APPLICATION
#

 

FILE DATE

 

REGISTRATION
#

 

REGISTRATION
DATE

 

STATUS

 

ACUFORM

 

CANADA

 

Depomed, Inc.

 

1307059

 

6/27/2006

 

TMA771374

 

7/6/2010

 

REGISTERED

 

ACUFORM

 

EUROPEAN UNION (CTM)

 

Depomed, Inc.

 

5152517

 

6/21/2006

 

5152517

 

10/4/2007

 

REGISTERED

 

ACUFORM

 

UNITED STATES

 

Depomed, Inc.

 

78781863

 

12/28/2005

 

3604419

 

4/7/2009

 

REGISTERED

 

BREAKING THROUGH: VOICES OF BREAKTHROUGH PAIN IN CANCER PATIENTS

 

UNITED STATES

 

Depomed, Inc.

 

85386630

 

8/2/2011

 

4335560

 

5/14/2013

 

REGISTERED

 

CAMBIA

 

CANADA

 

Depomed, Inc.

 

1492818

 

8/18/2010

 

TMA806381

 

9/9/2011

 

REGISTERED

 

CAMBIA

 

UNITED STATES

 

Depomed, Inc.

 

77441592

 

4/7/2008

 

3677383

 

9/1/2009

 

REGISTERED

 

CAMBIA & Design

 

CANADA

 

Depomed, Inc.

 

1648121

 

10/21/2013

 

 

 

 

 

PUBLISHED

 

CAMBIA & Design

 

UNITED STATES

 

Depomed, Inc.

 

85907106

 

4/17/2013

 

4541984

 

6/3/2014

 

REGISTERED

 

DEPOMED

 

UNITED STATES

 

Depomed, Inc.

 

74556760

 

8/3/1994

 

2112593

 

11/11/1997

 

REGISTERED

 

 

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

 



 

MARK

 

COUNTRY

 

OWNER

 

APPLICATION
#

 

FILE DATE

 

REGISTRATION
#

 

REGISTRATION
DATE

 

STATUS

 

DEPOMED & Design

 

CANADA

 

Depomed, Inc.

 

1307060

 

6/27/2006

 

TMA815153

 

1/9/2012

 

REGISTERED

 

DEPOMED & Design

 

EUROPEAN UNION (CTM)

 

Depomed, Inc.

 

5152491

 

6/21/2006

 

5152491

 

6/21/2006

 

REGISTERED

 

DEPOMED & Design

 

UNITED STATES

 

Depomed, Inc.

 

78781903

 

12/28/2005

 

3865964

 

10/19/2010

 

REGISTERED

 

 

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

 



 

MARK

 

COUNTRY

 

OWNER

 

APPLICATION
#

 

FILE DATE

 

REGISTRATION
#

 

REGISTRATION
DATE

 

STATUS

 

DEPOMED & Star Design

 

UNITED STATES

 

Depomed, Inc.

 

85114403

 

8/24/2010

 

4139790

 

5/8/2012

 

REGISTERED

 

DEPOMED SIMPLE SCRIPT

 

UNITED STATES

 

Depomed, Inc.

 

 

 

 

 

 

 

 

 

Unfiled

 

G & Design

 

UNITED STATES

 

Depomed, Inc.

 

86472401

 

12/5/2014

 

 

 

 

 

PENDING

 

GRALISE

 

CANADA

 

Depomed, Inc.

 

1469350

 

2/11/2010

 

 

 

 

 

ALLOWED

 

GRALISE

 

UNITED STATES

 

Depomed, Inc.

 

77934261

 

2/12/2010

 

4132334

 

4/24/2012

 

REGISTERED

 

HEAR ME & Design

 

UNITED STATES

 

Depomed, Inc.

 

86186380

 

2/6/2014

 

4605029

 

9/16/2014

 

REGISTERED

 

LAZANDA

 

UNITED STATES

 

Depomed, Inc.

 

85196378

 

12/13/2010

 

4068538

 

12/6/2011

 

REGISTERED

 

 

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

 



 

MARK

 

COUNTRY

 

OWNER

 

APPLICATION
#

 

FILE DATE

 

REGISTRATION
#

 

REGISTRATION
DATE

 

STATUS

 

LAZANDA & Design

 

UNITED STATES

 

Depomed, Inc.

 

85302528

 

4/22/2011

 

4104596

 

2/28/2012

 

REGISTERED

 

Lazanda Logo

 

UNITED STATES

 

Depomed, Inc.

 

85302550

 

4/22/2011

 

4104597

 

2/28/2012

 

REGISTERED

 

NEURONETWORX

 

UNITED STATES

 

Depomed, Inc.

 

85907087

 

4/17/2013

 

 

 

 

 

ALLOWED

 

PROQUIN

 

CANADA

 

Depomed, Inc.

 

1255613

 

4/27/2005

 

TMA679996

 

1/22/2007

 

DO NOT RENEW

 

PROQUIN

 

UNITED STATES

 

Depomed, Inc.

 

78356939

 

1/23/2004

 

2968719

 

7/12/2005

 

DO NOT RENEW

 

PROSORB

 

UNITED STATES

 

Depomed, Inc.

 

75544030

 

8/28/1998

 

2346573

 

5/2/2000

 

REGISTERED

 

SERADA

 

UNITED STATES

 

Depomed, Inc.

 

77040022

 

11/8/2006

 

3795949

 

6/1/2010

 

DO NOT RENEW

 

SIMPLESCRIPT

 

UNITED STATES

 

Depomed, Inc.

 

 

 

 

 

 

 

 

 

Unfiled

 

STAR DESIGN

 

CANADA

 

Depomed, Inc.

 

1583639

 

6/26/2012

 

 

 

 

 

PENDING

 

 

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

 



 

MARK

 

COUNTRY

 

OWNER

 

APPLICATION
#

 

FILE DATE

 

REGISTRATION
#

 

REGISTRATION
DATE

 

STATUS

 

STAR DESIGN

 

EUROPEAN UNION (CTM)

 

Depomed, Inc.

 

5152566

 

6/21/2006

 

05152566

 

9/20/2007

 

REGISTERED

 

Wave Design

 

UNITED STATES

 

Depomed, Inc.

 

79087404

 

9/6/2010

 

3988050

 

7/5/2011

 

REGISTERED

 

ZIPSOR

 

MEXICO

 

Xanodyne Pharmaceuticals, Inc.

 

1179843

 

5/20/2011

 

1244872

 

10/18/2011

 

REGISTERED

 

ZIPSOR

 

PUERTO RICO

 

Xanodyne Pharmaceuticals, Inc.

 

76506

 

5/27/2011

 

1244872

 

 

 

REGISTERED

 

ZIPSOR

 

UNITED STATES

 

Depomed, Inc.

 

77681532

 

3/2/2009

 

3732682

 

12/29/2009

 

REGISTERED

 

ZIPSOR

 

UNITED STATES

 

Depomed, Inc.

 

77219449

 

6/29/2007

 

3725984

 

12/15/2009

 

REGISTERED

 

NUCYNTA

 

UNITED STATES

 

Depomed, Inc.

 

77620713

 

4/21/2009

 

3732548

 

12/29/2009

 

REGISTERED

 

 

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

 



 

ANNEX G

 

DEPOSIT ACCOUNTS

 

 

Pledgor

 

Name of
Depository
Institution

 

Account
Name

 

Account Number

 

Type/Purpose

Depomed, Inc.

 

Wells Fargo Bank

 

N/A

 

[***]

 

Checking

Depomed, Inc.

 

Wells Fargo Bank

 

N/A

 

[***]

 

Checking

Depomed, Inc.

 

Wells Fargo Bank

 

N/A

 

[***]

 

Checking

 

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

 



 

ANNEX H

 

SECURITIES ACCOUNTS

 

Pledgor

 

Name of
Securities
Intermediary

 

Account
Name

 

Account Number

 

Type/Purpose

Depomed, Inc.

 

Oppenheimer

 

N/A

 

[***]

 

Investments

Depomed, Inc.

 

Wells Fargo Capital

 

N/A

 

[***]

 

Investments

Depomed, Inc.

 

Morgan Stanley Smith Barney

 

N/A

 

[***]

 

Investments

 

COMMODITY ACCOUNTS

 

[N/A]

 

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

 



 

ANNEX I

 

COMMERCIAL TORT CLAIMS

 

Depomed is a party to the litigations described under the caption “Depomed v. Gralise® ANDA Filers” in the “Legal Proceedings” section of Depomed’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 2, 2015.

 

NJ                                   3:2012-cv-01358        DEPOMED, INC. v. ACTAVIS ELIZABETH LLC et al

 

Depomed is a party to the litigations described under the caption “Depomed v. Banner Pharmacaps” in the “Legal Proceedings” section of Depomed’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 2, 2015.

 

NJ                                   2:2013-cv-04542        DEPOMED, INC. v. BANNER PHARMACAPS INC. et al

1:2013-cv-00653

 

Depomed is a party to the litigations described under the caption “Depomed v. Purdue and Depomed v. Endo Pharmaceuticals—Patent Infringement Litigation and Related Inter Partes Review Procee” in the “Legal Proceedings” section of Depomed’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 2, 2015.

 

NJ                                   3:2013-cv-02467        DEPOMED, INC. v. ENDO PHARMACEUTICALS INC.

3:2013-cv-00571        DEPOMED, INC. v. PURDUE PHARMA, L.P. et al

 

Acquired Commercial Tort Claims from Janssen Pharmaceutics, Inc. :

 

1. Janssen Pharmaceuticals, Inc. and Grunenthal GmbH v. Actavis Elizabeth LLC and Alkem Laboratories Ltd, 2:13-cv-04507 (D.N.J) filed on July 25, 2013; in discovery).

 

2. Janssen Pharmaceuticals, Inc. and Grunenthal GmbH v. Roxane Laboratories, Inc., 2:13-cv-06929 (D.N.J) (filed on November 14, 2013; in discovery).

 

3. Janssen Pharmaceuticals, Inc. and Grunenthal GmbH v. Alkem Laboratories Ltd., 2:13-cv-0783 (D.N.J) (filed on December 23, 2013; in discovery).

 

4. Janssen Pharmaceuticals, Inc. and Grunenthal GmbH v. Roxane Laboratories, Inc., 2:14-cv-03941 (D.N.J) (filed on June 19, 2014; in discovery).

 

5. Janssen Pharmaceuticals, Inc. and Grunenthal GmbH v. Watson Laboratories, Inc., 2:14-cv-04617(D.N.J) (filed on July 23, 2014; in discovery).

 

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

 



 

EXHIBIT A

 

GRANT OF SECURITY INTEREST IN COPYRIGHTS

 

WHEREAS , [NAME OF PLEDGOR] (the “ Pledgor ”) is the owner of the copyright applications and registrations listed on Schedule A attached hereto (all such copyrights, registrations and applications, collectively, the “ Copyrights ”); and

 

WHEREAS , the Pledgor has entered into a Pledge and Security Agreement (as amended, modified, restated or supplemented from time to time, the “ Security Agreement ”), dated as of April 2, 2015, in which the Pledgor has agreed with Deerfield Private Design Fund III, L.P., as Collateral Agent (the “ Collateral Agent ”), with offices at 780 Third Avenue, 37th Floor, New York, New York 10017, to execute this Grant;

 

NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, as security for the payment and performance of the Secured Obligations (as defined in the Security Agreement), the Pledgor does hereby grant to the Collateral Agent a security interest in all of its right, title and interest in and to the Copyrights, and the use thereof, together with all proceeds and products thereof.  This Grant has been given in conjunction with the security interest granted to the Collateral Agent under the Security Agreement, and the provisions of this Grant are without prejudice to and in addition to the provisions of the Security Agreement, which are incorporated herein by this reference.

 

This Grant of Security Interest in Copyrights and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Agreement shall be governed by, and construed in accordance with, the law of the State of New York.

 

 

[NAME OF PLEDGOR]

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

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

 



 

Schedule A

 

COPYRIGHTS AND COPYRIGHT APPLICATIONS

 

Owner

 

Application or
Registration No.

 

Country

 

Registration or
Filing Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

2



 

EXHIBIT B

 

GRANT OF SECURITY INTEREST
IN PATENTS AND TRADEMARKS

 

WHEREAS , [NAME OF PLEDGOR] (the “ Pledgor ”) is the owner of the trademark applications and registrations listed on Schedule A attached hereto, (all such trademarks, registrations and applications, collectively, the “ Trademarks ”) and is the owner of the patents and patent applications listed on Schedule A attached hereto (all such patents, registrations and applications, collectively, the “ Patents ”); and

 

WHEREAS , the Pledgor has entered into a Pledge and Security Agreement (as amended, modified, restated or supplemented from time to time, the “ Security Agreement ”), dated as of April 2, 2015, in which the Pledgor has agreed with Deerfield Private Design Fund III, L.P., as Collateral Agent (the “ Collateral Agent ”), with offices at 780 Third Avenue, 37th Floor, New York, New York 10017, to execute this Grant;

 

NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, as security for the payment and performance of the Secured Obligations (as defined in the Security Agreement), the Pledgor does hereby grant to the Collateral Agent a security interest in all of its right, title and interest in and to the Trademarks and the Patents, and the use thereof, together with all proceeds and products thereof and the goodwill of the businesses symbolized by the Trademarks.  This Grant has been given in conjunction with the security interest granted to the Collateral Agent under the Security Agreement, and the provisions of this Grant are without prejudice to and in addition to the provisions of the Security Agreement, which are incorporated herein by this reference.

 

This Grant of Security Interest in Patents and Trademarks and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Agreement shall be governed by, and construed in accordance with, the law of the State of New York.

 

 

[NAME OF PLEDGOR]

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

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

 



 

Schedule A

 

TRADEMARKS AND TRADEMARK APPLICATIONS

 

Owner

 

Mark

 

Application or
Registration No.

 

Country

 

Issue or
Filing Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PATENTS AND PATENT APPLICATIONS

 

Owner

 

Application or
Registration No.

 

Country

 

Inventor

 

Issue or
Filing Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

2



 

EXHIBIT C

 

FORM OF
PLEDGOR ACCESSION

 

THIS PLEDGOR ACCESSION (this “ Accession ”), dated as of                           , 20      , is executed and delivered by [NAME OF NEW PLEDGOR] , a                              (the “ New Pledgor ”), in favor of Deerfield Private Design Fund III, L.P., in its capacity as Collateral Agent under the Note Purchase Agreement referred to below (in such capacity, the “ Collateral Agent ”), pursuant to the Security Agreement referred to below.

 

Reference is made to the Note Purchase Agreement, dated as of March 12, 2015, among Depomed, Inc. (the “ Borrower ”), the Purchasers party thereto and the Collateral Agent (as amended, modified, restated or supplemented from time to time, the “ Note Purchase Agreement ”).  In connection with and as a condition to the purchase of the Notes by the Purchasers under the Note Purchase Agreement, (i) Depo NF Sub, LLC,  a Subsidiary of the Borrower (the “ Guarantor ”), pursuant to a Guaranty Agreement, dated as of the date of the Note Purchase Agreement (as amended, modified, restated or supplemented from time to time, the “ Guaranty Agreement ”), has guaranteed the payment in full of the obligations of the Borrower under the Note Purchase Agreement and the other Credit Documents (as defined in the Note Purchase Agreement), and (ii) the Borrower and the Guarantor, pursuant to a Pledge and Security Agreement, dated as of the date of the Note Purchase Agreement (as amended, modified, restated or supplemented from time to time, the “ Security Agreement ”), have granted in favor of the Collateral Agent a security interest in and Lien upon the Collateral described therein as security for their obligations under the Note Purchase Agreement, the Guaranty Agreement and the other Credit Documents.  Capitalized terms used herein without definition shall have the meanings given to them in the Security Agreement.

 

The Borrower has agreed under the Note Purchase Agreement to cause certain of its future direct and indirect subsidiaries to become a party to the Guaranty Agreement as a guarantor thereunder and to the Security Agreement as a Pledgor thereunder.  The New Pledgor is a direct or indirect subsidiary of the Borrower and, as required by the Note Purchase Agreement, has become a guarantor under the Guaranty Agreement as of the date hereof.  The New Pledgor will obtain benefits as a result of the sale by the Borrower of the Notes to the Purchaser under the Note Purchase Agreement, which benefits are hereby acknowledged, and, accordingly, desire to execute and deliver this Accession.  Therefore, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and as further inducement to the Purchasers in connection with their purchase of the Notes from the Borrower under the Note Purchase Agreement, the New Pledgor hereby agrees as follows:

 

1.                                       The New Pledgor hereby joins in and agrees to be bound by each and all of the provisions of the Security Agreement as a Pledgor thereunder.  In furtherance (and without limitation) of the foregoing, pursuant to Section 2.1 of the Security Agreement, and as security for all of the Secured Obligations, the New Pledgor hereby pledges, assigns and delivers to the Collateral Agent, for the ratable benefit of the Secured Parties, and grants to the Collateral

 

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

 



 

Agent, for the ratable benefit of the Secured Parties, a Lien upon and security interest in, all of its right, title and interest in and to the Collateral as set forth in Section 2.1 of the Security Agreement, all on the terms and subject to the conditions set forth in the Security Agreement.

 

2.                                       The New Pledgor hereby represents and warrants that (i)  Schedule 1 hereto sets forth all information required to be listed on Annexes A, B, C, D, E, F, G, H and I to the Security Agreement in order to make each representation and warranty contained in Sections 3.1 and 3.2 of the Security Agreement true and correct with respect to the New Pledgor as of the date hereof and after giving effect to this Accession and (ii) after giving effect to this Accession and to the incorporation into such Annexes, as applicable, of the information set forth in Schedule 1 , each representation and warranty contained in Article III of the Security Agreement is true and correct with respect to the New Pledgor as of the date hereof, as if such representations and warranties were set forth at length herein.

 

3.                                       This Accession shall be a Credit Document (within the meaning of such term under the Note Purchase Agreement), shall be binding upon and enforceable against the New Pledgor and its successors and assigns, and shall inure to the benefit of and be enforceable by each Secured Party and its successors and assigns.  This Accession and its attachments are hereby incorporated into the Security Agreement and made a part thereof.

 

This Accession and any claims, controversy, dispute or cause of action (whether in contract or tort or otherwise) based upon, arising out of or relating to this Agreement shall be governed by, and construed in accordance with, the law of the State of New York.

 

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

 

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IN WITNESS WHEREOF , the New Pledgor has caused this Accession to be executed under seal by its duly authorized officer as of the date first above written.

 

 

 

[NAME OF NEW PLEDGOR]

 

 

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

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

 

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Schedule 1

 

Information to be added to Annex A of the Security Agreement:

 

FILING LOCATIONS

 

Name of Pledgor

 

Filing Location

 

 

 

 

 

 

 

 

 

 

Information to be added to Annex B of the Security Agreement:

 

JURISDICTION OF ORGANIZATION, CERTAIN LOCATIONS

 

[ Name of Pledgor : ]

 

Jurisdiction of Incorporation/Organization:

 

Federal Tax ID no.:

 

Organizational ID no.:

 

Chief Executive Office Address:

 

Locations of Records Related to Collateral:

 

Locations of Equipment or Inventory:

 

Other places of business:

 

Trade/fictitious or prior corporate names
(last five years):

 

Names used in tax filings (last five years):

 

Information to be added to [ Annexes C/D/E/F/G/H/I ] of the Security Agreement:

 

[ Complete as applicable ]

 

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

 

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EXHIBIT D

 

PLEDGE AMENDMENT

 

THIS PLEDGE AMENDMENT , dated as of                               , 20      , is delivered by [NAME OF PLEDGOR] (the “ Pledgor ”) pursuant to Section 5.1 of the Security Agreement referred to below.  The Pledgor hereby agrees that this Pledge Amendment may be attached to the Pledge and Security Agreement, dated as of April 2, 2015, made by the Pledgor and certain other pledgors named therein in favor of Deerfield Private Design Fund III, L.P., as Collateral Agent (as amended, modified, restated or supplemented from time to time, the “ Security Agreement ,” capitalized terms defined therein being used herein as therein defined), and that the Pledged Interests listed on Schedule 1 to this Pledge Amendment shall be deemed to be part of the Pledged Interests within the meaning of the Security Agreement and shall become part of the Collateral and shall secure all of the Secured Obligations as provided in the Security Agreement.  This Pledge Amendment and its attachments are hereby incorporated into the Security Agreement and made a part thereof.

 

 

 

[NAME OF PLEDGOR]

 

 

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

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

 



 

Schedule 1

 

PLEDGED INTERESTS

 

Name of Issuer

 

Type of
Interests

 

Certificate
Number

 

No. of shares
(if applicable)

 

Percentage of
Outstanding Interests
in Issuer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 


Exhibit 10.3

 

CERTAIN MATERIAL (INDICATED BY [***] ) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

ASSIGNMENT AND CONSENT AGREEMENT

 

THIS ASSIGNMENT AND CONSENT AGREEMENT (this “ Assignment Agreement ”) is entered into this 13th day of January, 2015 (the “ Execution Date ”) by and between

 

GRÜNENTHAL GMBH, organized under the laws of Germany and having its principal office at Zieglerstraße 6, 52078 Aachen, Germany (hereinafter “ GRÜNENTHAL ”), and

 

Janssen Pharmaceuticals, Inc., a Delaware corporation having a principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey, 08560 and Janssen Research & Development, LLC having a principal place of business at U.S. Route 202, Raritan, New Jersey 08869 (hereinafter collectively “ OMP ),

 

and is joined by Depomed, Inc., organized under the laws of California and having its principal office at 7999 Gateway Blvd., Suite 300, Newark, California 94560 (hereinafter “ PURCHASER ”) upon PURCHASER’s execution of a joinder to this Assignment Agreement pursuant to paragraph 2 hereof .

 

WHEREAS, OMP and GRÜNENTHAL entered into a License Agreement dated February 21, 2003 , which License Agreement was amended as of December 23, 2004 and June 21, 2006 and then amended and restated in its entirety in an Amended and Restated License Agreement dated December 28, 2006, which Amended and Restated License Agreement was amended as of June 19, 2007, December 17, 2008, January 16, 2009, May 22, 2009, July 15, 2010 and May 29, 2013 (such Amended and Restated License Agreement, together with all amendments thereto, the “ Combined Territories License Agreement ”) and then amended and restated in its entirety in two (2) agreements: (a)  a License Agreement (U.S.) with an effective date of January 13, 2015 (the “ Agreement ”), pursuant to which inter alia GRÜNENTHAL agreed to license to OMP certain patents and know-how regarding composition of matter CG-5503 and pharmaceutical formulations containing CG-5503 as active pharmaceutical ingredient (the “ Product ”), as well as certain drug delivery systems for delivery of CG-5503, and to grant manufacturing, commercialization and certain other rights to OMP for the Product in the United States of America (the “ Territory ”) and (b) a License Agreement (Canada/Japan) with an effective date of January 13, 2015 (the “ Canada/ Japan License Agreement ”), pursuant to which inter alia GRÜNENTHAL agreed to license to OMP certain patents and know-how regarding composition of matter CG-5503 and the Product, as well as certain drug delivery systems for delivery of CG-5503, and to grant manufacturing, commercialization and certain other rights to OMP for the Product in Canada and Japan;

 

WHEREAS, OMP and/or one or more of its affiliates (collectively, the “ Selling Entities ”) and PURCHASER are discussing the possibility of entering into a transaction pursuant to which the Selling Entities would sell (or to cause to be sold), and PURCHASER would purchase, certain assets and rights related to the Product (including OMP’s rights under the Agreement), and PURCHASER would assume certain liabilities related to the Product (the “ Transaction ”);

 

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

 



 

WHEREAS, in the event one or more of the Selling Entities and PURCHASER agree to enter into the Transaction, such Selling Entities and PURCHASER would enter into an asset purchase agreement setting forth the terms and conditions upon which the Transaction shall be consummated (the “ Asset Purchase Agreement ”); and

 

WHEREAS, pursuant to Section 18.5 of the Agreement, OMP cannot assign the Agreement in whole to PURCHASER without the prior written consent of GRÜNENTHAL, which consent (in accordance with Section 18.11 of the Agreement) cannot unreasonably be withheld, and GRÜNENTHAL desires to consent to such assignment, subject to the terms and conditions of this Assignment Agreement;

 

NOW, THEREFORE, OMP, PURCHASER and GRÜNENTHAL agree as follows:

 

1.                                       As of the Execution Date, GRÜNENTHAL hereby irrevocably consents to the assignment of the Agreement to PURCHASER as contemplated in paragraphs 5 and 6 below and under the terms and conditions of this Assignment Agreement.

 

2.                                       In the event one or more of the Selling Entities and PURCHASER enter into the Asset Purchase Agreement:

 

2.1.                             PURCHASER shall execute a joinder to this Assignment Agreement in substantially the form of Exhibit A attached hereto, and shall thereafter be a party to this Assignment Agreement and shall be fully bound by, and subject to, all of the terms and conditions of this Assignment Agreement; and

 

2.2.                             within two (2) working days after the execution of the Asset Purchase Agreement, OMP shall notify GRÜNENTHAL in accordance with Article 18.16 of the Agreement of such execution and deliver to GRÜNENTHAL a copy of such executed joinder.

 

3.                                       In the event the closing of the Transaction occurs:

 

3.1.                             OMP shall notify GRÜNENTHAL in accordance with Article 18.16 of the Agreement within two (2) working days of the closing of the Transaction;

 

3.2.                             the date of such closing shall be referred to as the “ Closing Date ” in this Assignment Agreement; and

 

3.3.                             the provisions of paragraphs 5 through 18 below shall become effective.

 

4.                                       If OMP does not notify GRÜNENTHAL of the closing of the Transaction in accordance with paragraph 3.1 on or before September 30, 2015, then this Assignment Agreement (including all amendments to the Agreement set forth in this Assignment Agreement), the Agreement and the Canada/Japan License Agreement shall each become null and void, and be of no further force and effect, as of October 1, 2015 and the Combined Territories License Agreement shall become effective on October 1, 2015.

 

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

 

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5.                                       As of the Closing Date, OMP hereby assigns to PURCHASER all of the rights, licenses, claims, obligations and duties of OMP under the Agreement.

 

6.                                       As of the Closing Date, PURCHASER hereby accepts such assignment, and assumes all of the rights, licenses, claims, obligations and duties of OMP under the Agreement by way of assumption of contract with debt discharging effect ( im Wege der Vertragsübernahme mit schuldbefreiender Wirkung ) to the same extent and with the same effect, as if it had been an original party thereto instead of OMP; provided, however, that PURCHASER does not assume, and PURCHASER shall have no liability to GRÜNENTHAL or its Affiliates with respect to, any Discharged GRÜNENTHAL Claim (as such term is defined in paragraph 8 of this Assignment Agreement).

 

7.                                       As of the Closing Date, any claims of GRÜNENTHAL against Johnson & Johnson, as guarantor of OMP pursuant to Article 19.1 of the Agreement, arising out of the Agreement are hereby discharged by way of agreement in favor of a third party ( Vertrag zugunsten Dritter ) pursuant to Sec. 328 German Civil Code ( BGB ), and the provisions of Article 19.1 of the Agreement shall be of no further force and effect.

 

8.                                       As of the Closing Date, except as provided in paragraphs 9 and 10: (a) any claims of OMP or its Affiliates against GRÜNENTHAL or its Affiliates arising out of the Agreement or the Combined Territories License Agreement are hereby discharged; and (b) any claims of GRÜNENTHAL or its Affiliates against OMP or its Affiliates arising out of the Agreement or the Combined Territories License Agreement (“ Discharged GRÜNENTHAL Claims ”) are hereby discharged; this is an agreement in favor of a third party ( Vertrag zugunsten Dritter ) pursuant to Sec. 328 German Civil Code ( BGB ) for the benefit of OMP’s Affiliates and GRÜNENTHAL’s Affiliates, as applicable.  In addition, effective as of the Closing Date, GRÜNENTHAL hereby irrevocably waives any right that GRÜNENTHAL may have, or may have had, to terminate the Agreement for, or by virtue of, any Discharged GRÜNENTHAL Claim.  OMP shall indemnify and hold harmless GRÜNENTHAL from any claims for payment of royalties or other amounts pursuant to the following agreements which OMP has entered into with Third Parties regarding the Product: [***].

 

9.                                       Payment obligations .  GRÜNENTHAL shall remain liable to OMP for any payment obligations of GRÜNENTHAL under the Agreement that accrued prior to the Closing Date, and OMP shall remain liable to GRÜNENTHAL for any payment obligations of OMP that accrued prior to the Closing Date, including the payment of royalties based on Net Sales of Products that occurred prior to the Closing Date.  For the sake of clarity, and notwithstanding anything to the contrary in the Agreement or the Canada/Japan Agreement, the Parties acknowledge and agree that costs associated with the ongoing Core Pediatric Program do not relate to the territories of Canada or Japan and, accordingly, that any such costs incurred on or after the Closing Date shall be shared by GRÜNENTHAL and PURCHASER as set forth in the Agreement, not by GRÜNENTHAL and OMP under the Canada/Japan Agreement.  For the sake of clarity, and notwithstanding anything to the contrary in the Canada/Japan Agreement, GRÜNENTHAL and OMP acknowledge and agree that the Proportionate Share provisions set forth in Section 6.1(e) of the Canada/Japan Agreement do not apply to new preclinical or clinical studies commenced on or after the Closing Date.

 

10.                                Notwithstanding anything to the contrary in paragraph 5 or 6:

 

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

 

3



 

10.1.                      the obligations set forth in Article 8 of the Agreement (as in effect immediately prior to the Closing Date) shall continue to apply to OMP and GRÜNENTHAL with respect to any Confidential Information disclosed prior to the Closing Date, until the [***] anniversary of the Closing Date;

 

10.2.                      OMP shall remain liable to GRÜNENTHAL for [***], and GRÜNENTHAL shall remain liable to OMP for [***];

 

10.3.                      the rights and obligations set forth in Article 13 of the Agreement (as in effect immediately prior to the Closing Date) shall continue to apply to OMP and GRÜNENTHAL with respect to any claims arising out of activities conducted prior to the Closing Date; and

 

10.4.                      the provisions of Article 1 and Article 18 of the Agreement (as in effect immediately prior to the Closing Date) shall continue to apply, to the extent necessary to interpret any of the foregoing provisions of the Agreement.

 

11.                                Certain Licenses.

 

11.1.                      As of the Closing Date, PURCHASER hereby grants to OMP and OMP’s Affiliates a non-exclusive, royalty-free sublicense under the rights granted by GRÜNENTHAL to PURCHASER under the Agreement, solely to the extent necessary to enable OMP and OMP’s Affiliates to perform its and their obligations under the Asset Purchase Agreement and related ancillary agreements, and GRÜNENTHAL hereby consents to such sublicense.

 

11.2.                      GRÜNENTHAL and OMP acknowledge and agree that, notwithstanding the execution of the Agreement, the Canada/Japan License Agreement or this Assignment Agreement, the rights and licenses granted by GRÜNENTHAL to OMP pursuant to the following provisions of the Combined Territories License Agreement shall continue in full force and effect in perpetuity following the Closing Date, but only with respect to Improvements, Information and Patents that are subject to one of the following provisions on the day prior to the Closing Date and only to the extent that such Improvements, Information, and Patents remain in the Control of GRÜNENTHAL or any of its Affiliates after the Closing Date: [***]

 

11.2.6.            [***]; and

 

11.2.7.            all other provisions of the Combined Territories License Agreement that must survive in order to interpret or give effect to any of the foregoing provisions of the Combined Territories License Agreement.

 

11.3.                      GRÜNENTHAL and OMP acknowledge and agree that, notwithstanding the execution of the Agreement, the Canada/Japan License Agreement or this Assignment Agreement, the rights and licenses granted by OMP to GRÜNENTHAL pursuant to the following provisions of the Combined Territories License Agreement shall continue in full force and effect in perpetuity following the Closing Date, but only with respect to Improvements, Information and Patents that are subject to one of the following provisions on the day prior to the Closing Date and only to the extent that such Improvements, Information and Patents remain in the Control of OMP or any of its Affiliates after the Closing Date: [***]

 

11.3.10.     [***]; and

 

11.3.11.     all other provisions of the Combined Territories License Agreement that must survive in order to interpret or give effect to any of the foregoing provisions of the Combined Territories License Agreement.

 

12.                                Right relating to the manufacture of CG-5503 .  [***](1)

 

13.                                Amendment to Defined Term “OMP” .  All references in the Agreement to OMP shall be deemed to refer to Depomed, Inc.

 

14.                                Amendments to Article 2 of the Agreement .  Article 2 of the Agreement shall be amended as set forth in this paragraph 14.

 

14.1.                      A new Section 2.1(g) is hereby added to the end of Section 2.1 of the Agreement, with the following language: “ Excluded Products .  In the event that Grünenthal develops an Excluded Product and, after the first sale in an arms length transaction and shipment of such Excluded Product to a Third Party (other than an Affiliate or licensee of Grünenthal) by Grünenthal (or its Affiliate or licensee) in the OMP Territory following applicable Regulatory Approval of such Excluded Product in the OMP Territory (such sale, the “ Grünenthal First Commercial Sale ”), there is no composition of matter Patent in the US or EU claiming any of the active pharmaceutical ingredients

 


(1) One page omitted and filed separately with the Commission.

 

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

 

4



 

that were New Chemical Entities at the time of such Grünenthal First Commercial Sale (i.e., such active pharmaceutical ingredients no longer qualify as “New Chemical Entities”), then such Excluded Product shall be deemed to be a Combination Product for purposes of this Agreement, except that the exclusive licenses granted by Grünenthal to OMP under Section 2.1 shall be co-exclusive between Grünenthal and OMP with respect to such Combination Product.  Notwithstanding anything to the contrary in this Agreement, with respect to any Excluded Product that subsequently becomes a Combination Product pursuant to this Section 2.1(g), OMP shall have no right to access or use any Information developed by Grünenthal under its RAP for such Combination Product.  For purposes of this Section 2.1(g) , “ Excluded Product ” means a pharmaceutical product containing CG-5503 in combination with one or more New Chemical Entities.”

 

14.2.                      Section 2.2(b) of the Agreement is hereby amended, superseded and replaced in its entirety to read as follows:  “ Licenses for Production . OMP hereby grants to Grünenthal a non-exclusive royalty bearing, license, within the Field under the Improvement Combination Patents and OMP Know-How, to make or have made Products worldwide solely for the purpose of Commercialization of Products within the Grünenthal Territory under the license for Commercialization granted under Section 2.2(a) . OMP hereby grants to Grünenthal a non-exclusive royalty free license within the Field under Improvement Patents other than Improvement Combination Patents to make or have made Products worldwide solely for the purpose of Commercialization of Products within the Grünenthal Territory under the license for Commercialization granted under Section 2.2(a) ; provided, however, that Grünenthal shall be responsible for any payment due to a Third Party in the Grünenthal Territory under such Improvement Patents.  In the event OMP and its Affiliates permanently discontinue all manufacture and supply of the active pharmaceutical ingredient CG-5503 (“ API ”), OMP shall grant to Grünenthal a non-exclusive royalty free license within the Field under Improvement Patents other than Improvement Combination Patents to make or have made API worldwide for the commercialization of the Product in the countries licensed by OMP from Grünenthal; provided , however , that Grünenthal shall be responsible for any payment due to a Third Party with respect to such API manufacturing activities under such Improvement Patents.”

 

15.                                Amendments to Article 4 of the Agreement .  Article 4 of the Agreement shall be amended as set forth in this paragraph 15.

 

15.1.                      Three new sentences are hereby added to end of Section 4.1 ( Commercialization Efforts) of the Agreement with the following language: “OMP shall use Commercially Reasonable Efforts to Commercialize the Product in the OMP Territory.  For purposes of this Section 4.1, ‘Commercially Reasonable Efforts’ means those efforts and resources customarily used in the pharmaceutical business by a [***] pharmaceutical company for a product owned by such company or to which such company has rights, which product is of a market potential similar to the market potential of the Product and at a similar stage of its product life as the Product, taking into account all relevant factors, including, without limitation, the risks inherent in the Commercialization of the Product, the competitiveness of the marketplace, the proprietary position of the Product in comparison to other products in a Party’s product portfolio, the regulatory status of the Product (including pricing and reimbursement status), the actual and potential profitability of the Product, and the general economic conditions of the marketplace, as well as other relevant factors.”

 

15.2.                      A new Section 4.9 is hereby added to the end of Article 4 of the Agreement, with the following language:

 

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

 

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“4.9                          Periodic Business Review .

 

OMP shall, within 45 days after June 30 and December 31 of each calendar year during the Term, deliver to Grünenthal a report covering the six month period ending on such date, which report shall include the following information with respect to such six month period (to the extent and in the manner prepared in the ordinary course of OMP’s business):

 

·                                         Product TRx performance (moving annual total);

·                                         Managed care access update for Products in the OMP Territory (including number of plans, lives, formulary status and geographic area);

·                                         Sales call activity in the OMP Territory (including PDEs delivered with respect to Products); and

·                                           an update on clinical activities undertaken with respect to Products.

 

Grünenthal shall limit distribution of reports provided by OMP under this Section 4.9 only to senior Grünenthal legal, finance and commercial personnel with a legitimate need to review such reports to assess OMP’s compliance with its obligations under Section 4.1.

 

This Section 4.9 shall be applicable during the period beginning on December 31, 2015 and ending on the last day of the Term.”

 

15.3.                      A new Section 4.10 is hereby added to the end of Article 4 of the Agreement, with the following language:

 

“4.10 Annual Strategic Plan Information .

 

OMP shall, in December of each calendar year during the Term, deliver to Grünenthal a marketing overview for the Products in the OMP Territory for the upcoming calendar year, which marketing overview shall include the following information with respect to such upcoming calendar year (to the extent and in the manner prepared in the ordinary course of OMP’s business):

 

·                                           Sales forecast for Products in the OMP Territory (TRx and net sales);

·                                         Sales call plan for Products in the OMP Territory prepared in the ordinary course of OMP’s business (including segmentation methodology, prescriber targets and PDEs); and

·                                         Marketing budget for Products in the OMP Territory and a summary of key marketing tactics.

 

In addition, OMP shall, in December of the calendar years 2015, 2016 and 2017, inform Grünenthal of the communication positioning strategy for the Products in the OMP Territory for the upcoming calendar year.

 

Grünenthal shall limit distribution of information provided by OMP under this Section 4.10 only to senior Grünenthal legal, finance and commercial personnel with a legitimate need to review such reports to assess OMP’s compliance with its obligations under Section 4.1.”

 

16.                                Amendments to Article 6 of the Agreement .  Article 6 of the Agreement shall be amended as set forth in this paragraph 16.

 

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

 

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16.1.                      A new sentence is hereby added to end of Section 6.9 (Cost of Goods Sold Cap (“COGS Cap”) in OMP Territory) with the following language:  [***].

 

16.2.                      Section 6.12 of the Agreement is hereby amended, superseded and replaced in its entirety to read as follows:

 

“6.12                     Royalty Reports and Records; Estimates .

 

(a)                                   During the term of this Agreement and commencing with the First Commercial Sale of Product, OMP shall furnish, or cause to be furnished to Grünenthal, written reports, including the applicable royalty payment due, within forty-five (45) days following the end of each calendar half-year for which royalties are due, showing:

 

(i)                                        the detailed calculation of monthly Net Sales of all Products sold by OMP and its Affiliates during the calendar half-year;

 

(ii)                                     the detailed calculation of Earned Royalties, payable in U.S. Dollars, which shall have accrued hereunder in respect to such Net Sales; and

 

(iii)                                  any withholding taxes required to be paid from such Earned Royalties.

 

(b)                                   All Earned Royalties payments to be made by OMP to Grünenthal shall be made in U.S. Dollars, within forty-five (45) days following the end of each calendar half-year for which such Earned Royalties are due, to a Grünenthal bank account.

 

(c)                                   OMP shall keep accurate records in sufficient detail to enable Earned Royalties and other payments payable hereunder to be determined. OMP shall be responsible for all Earned Royalties and late payments that are due to Grünenthal that have not been paid by OMP or its Affiliates. Late payments shall accrue interest on an annual basis at a rate of [***].

 

(d)                                  OMP and its Affiliates shall maintain complete and accurate records, in accordance with United States generally accepted accounting principles, which are relevant to costs, expenses and payments under this Agreement and such records shall be open during reasonable business hours for a period of [***] from creation of individual records for examination at Grünenthal’s expense and not more often than once each year by a certified public accountant or other representative selected by Grünenthal and acceptable to OMP for the sole purpose of verifying the correctness of calculations or such costs, expenses or payments made under this Agreement.  In the absence of material discrepancies (in excess of [***]) in any request for reimbursement resulting from such audit, the accounting expense shall be paid by Grünenthal. If material discrepancies do result, OMP shall bear the reasonable audit expense. Any records or accounting information received from OMP shall be Confidential Information for purposes of Article 8 .

 

(e)                                   OMP shall submit to Grünenthal, by December 15 of each calendar year during the Term, a preliminary non-binding, interim statement (without payment), which statement shall include the following information for the calendar half-year ending on December 31 of the current calendar year:  estimated gross sales; estimated permitted deductions; estimated Net Sales; and estimated units of each Product reasonably likely to be sold by OMP, its Affiliates or its sublicensees.”

 

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

 

7



 

17.                                Amendments to Article 15 of the Agreement .  Article 15 of the Agreement shall be amended as set forth in this paragraph 17.

 

17.1.                      A new Section 15.14 is hereby added to the end of the Article 15 of the Agreement, with the following language:

 

“15.14            Termination for Challenge of Grünenthal Patents .  In the event that, after the Closing Date, OMP or any of its Affiliates initiates, or assists a Third Party in initiating, a patent re-examination, inter partes review, post grant or other patent office proceeding, opposition, litigation, or other court proceeding challenging the validity of any issued U.S. patent within the Grünenthal Patents licensed under this Agreement (a “ Patent Challenge ”), Grünenthal may terminate this Agreement upon sixty (60) days’ written notice to OMP, unless such Patent Challenge is terminated or withdrawn by the end of such 60-day notice period; provided , however , that none of the following shall constitute a Patent Challenge or entitle Grünenthal to terminate this Agreement pursuant to this Section 15.14:

 

(i)                                        OMP’s or its Affiliate’s assertion of invalidity as a defense in any court proceeding brought by Grünenthal or any of its Affiliates or its or their respective licensees asserting infringement of an issued U.S. patent within the Grünenthal Patents licensed under this Agreement;

 

(ii)                                     OMP’s or its Affiliate’s acquisition of or by a Third Party that, prior to consummation of such acquisition, has an existing challenge, whether in a court or administrative proceeding, against an issued U.S. patent within the Grünenthal Patents licensed under this Agreement (an “ Existing Challenge ”); or

 

(iii)                                  after OMP’s or its Affiliate’s acquisition of or by a Third Party that has an Existing Challenge, the continued prosecution of such Existing Challenge by the surviving entity in such acquisition transaction.”

 

17.2.                      A new Section 15.15 is hereby added to the end of the Article 15 of the Agreement, with the following language:

 

“15.15            Effects upon Termination .  In the event of termination of this Agreement by Grünenthal pursuant to Section 15.14, the licenses and rights granted to Grünenthal in Articles 2 and 12 (if the Parties have previously agreed to jointly develop OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Application and Regulatory Approvals including all clinical data associated therewith.”

 

18.          Ongoing Patent Litigation in the United States on Orange Book listed patents for the Nucynta®, Nucynta® ER, and Nucynta® oral solution Products (collectively, “Litigations”)

 

18.1.       General

 

PURCHASER agrees to be named as a party plaintiff in the Litigations as an exclusive licensee from the closing of the Transaction.

 

On the closing of the Transaction, OMP will file papers seeking to dismiss OMP as a plaintiff and to join PURCHASER as a plaintiff and/or substitute PURCHASER as a plaintiff in the Litigations. OMP shall either obtain agreement from the defendants in the Litigations for OMP to be dismissed as a counterclaim defendant or shall itself move to be dismissed as a counterclaim defendant.

 

18.2.       Joint Litigation Agreement

 

PURCHASER hereby assumes and OMP would not object to PURCHASER assuming the rights and obligations of OMP under the Joint Litigation Agreement [***], and accepting all the terms and conditions of that Agreement (the “Joint Litigation Agreement”). [***]

 

So as not to disrupt the ongoing Litigations, to avoid the necessity of new litigation counsel having to get up to speed while the Litigations are ongoing, and to avoid GRÜNENTHAL’s counsel from having to take on additional responsibilities for the Litigations, PURCHASER agrees to have and further subject to resolution of any conflicts of interest to the satisfaction of OMP, [***]

 

18.3.       Community of Interest, Confidentiality and Joint Defense Agreement

 

PURCHASER agrees and OMP does not object to PURCHASER agreeing to enter into and being bound by the Community of Interest, Confidentiality and Joint Defense Agreement dated [***] between GRÜNENTHAL and OMP, in order to permit confidential communications between the Parties and the parties to that agreement that involve Janssen Pharmaceuticals, Inc., Janssen Research and Development LLC, or their predecessors-in-interest and concern the enforcement and defense of the GRÜNENTHAL Patents.

 

PURCHASER agrees and OMP does not object to PURCHASER agreeing to enter into and being bound by a Community of Interest, Confidentiality and Joint Defense Agreement with GRÜNENTHAL, having the same terms and conditions as the [***] Community of Interest, Confidentiality and Joint Defense Agreement in order to permit confidential communications between GRÜNENTHAL and PURCHASER concerning the future enforcement and defense of the GRÜNENTHAL Patents.

 

18.4.       Cooperation and Assistance.

 

Upon GRÜNENTHAL’s or PURCHASER’s reasonable request, OMP shall assist and provide support to the requesting party with regard to the Litigations.  The requesting party shall reimburse OMP for its reasonable internal and out-of-pocket costs related to such assistance and support (other than the costs of any OMP actions that are required by a court, including depositions of OMP’s witnesses, related preparations of OMP’s witnesses and production of OMP-documents for discovery, which costs OMP will bear).

 

19.                                This Assignment Agreement shall become effective as of the Execution Date and shall continue in effect in perpetuity except as provided in paragraph 4.  The provisions of

 

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

 

8



 

paragraphs 1 through 4, this paragraph 19 and paragraphs 20, 21, 22 and 23 shall become effective on the Execution Date and shall be legally binding on OMP, GRÜNENTHAL and (upon the execution of the joinder pursuant to paragraph 2) PURCHASER as of the Execution Date.  The other provisions of this Assignment Agreement shall not become effective until the Closing Date.  Paragraphs 13 through 18 of this Assignment Agreement constitute an amendment of the Agreement pursuant to Section 18.6 of the Agreement; all other terms and conditions of the Agreement shall remain in full force and effect.

 

20.                                All definitions used in this Assignment Agreement shall have the meaning as set forth in the Agreement, unless expressly defined otherwise in this Assignment Agreement. Wherever this Assignment Agreement includes English terms after which, either in the same provision or elsewhere in this Assignment Agreement, German terms have been inserted in brackets and italics, the respective German terms shall be decisive for the interpretation of the relevant English term.  In the event that facts have to be judged under foreign law, the use of a legal term of German law comprises the use of the — analogously by content and function — closest foreign legal term. This Assignment Agreement may be executed in one or more counterparts, each of which shall be deemed an original, and together shall constitute one and the same agreement binding on all of the parties and shall become effective when one or more counterparts have been signed by a party and delivered to the other parties, it being understood that none of the parties need sign the same counterpart.  This Assignment Agreement, following its execution, may be delivered via Telecopier machine or other form of electronic delivery, which shall constitute delivery of an execution original for all purposes.

 

21.                                This Assignment Agreement may be amended, supplemented or otherwise modified at any time, but only by means of a written instrument signed by all of the parties.

 

22.                                All notices and other communications given or made pursuant to this Assignment Agreement shall be in writing and shall be deemed to have been duly given on the date delivered, if delivered personally, or on the next business day after being sent by reputable overnight courier (with delivery tracking provided, signature required and delivery prepaid), in each case, to the parties at the following addresses, or on the date sent and confirmed by electronic transmission to the telecopier number specified below (or at such other address or telecopier number for a party as shall be specified by notice given in accordance with this paragraph 22):

 

22.1.                      If to GRÜNENTHAL:

 

Grünenthal GmbH

52099 Aachen

Germany

Attention: CEO

Fax:

 

22.2.                      If to OMP:

 

Janssen Pharmaceuticals, Inc.

1125 Trenton-Harbourton Road

Titusville, New Jersey 08560

Attention: President

Fax:

 

with a copy to:

 

Johnson & Johnson

One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933

Attention: Corporate Law Leader, Medicines & Nutritionals

Fax:

 

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

 

9



 

22.3.                      If to Depomed, Inc.:

 

To the address set forth in Exhibit A.

 

23.                                Article 16, Section 18.1, Section 18.3, Section 18.4, Section 18.7, Section 18.8, Section 18.14 and Section 18.17 of the Agreement shall apply mutatis mutandis to this Assignment Agreement.

 

[Remainder of this page intentionally left blank.]

 

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

 

10



 

IN WITNESS WHEREOF, the parties have caused this Assignment Agreement to be entered into as of the Execution Date.

 

 

GRÜNENTHAL GMBH

 

 

 

 

 

 

 

 

 

 

By:

/s/ Prof. Dr. Eric-Paul Pâques

 

 

 

 

 

 

Name:

Prof. Dr. Eric-Paul Pâques

 

 

 

 

 

 

Title:

CEO

 

 

 

 

 

 

By:

/s/ Dr. Alberto Grua

 

 

 

 

 

 

Name:

Dr. Alberto Grua

 

 

 

 

 

 

Title:

Chief Commercial Officer EU,

 

 

 

Australia and North America

 

 

 

 

 

 

 

 

 

 

JANSSEN PHARMACEUTICALS, INC.

 

JANSSEN RESEARCH & DEVELOPMENT, LLC

 

 

 

 

 

 

 

 

 

By:

/s/ Michael Grissinger

 

By:

/s/ Michael Grissinger

 

 

 

 

 

Name:

Michael Grissinger

 

Name:

Michael Grissinger

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Authorized Signatory

 

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

 

[Signature Page to Assignment and Consent Agreement]

 



 

EXHIBIT A

 

FORM OF JOINDER AGREEMENT

 

JOINDER AGREEMENT dated as of January 15, 2015 made by the undersigned (the “ Joining Party ”).

 

Reference is hereby made to the Assignment and Consent Agreement, dated as of January 15, 2015 (the “ Assignment Agreement ”) by and among GRÜNENTHAL GMBH, Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC. Capitalized terms used herein without definition shall have the meanings assigned to them in the Assignment Agreement.

 

Pursuant to and in accordance with paragraph 2 of the Assignment Agreement, the Joining Party hereby agrees that, upon the execution of this Joinder Agreement, it shall become a party to the Assignment Agreement and shall be fully bound by, and subject to, all of the terms and conditions of the Assignment Agreement as “PURCHASER” in such capacity as though the undersigned was an original party thereto.

 

IN WITNESS WHEREOF, the Joining Party hereto has executed this Joinder Agreement as of January 15, 2015.

 

 

 

DEPOMED, INC.

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

Name:

James A. Schoeneck

 

Title:

President and Chief Executive Officer

 

 

 

Notice Address:

 

Depomed. Inc.

 

7999 Gateway Blvd

 

Suite 300

 

Newark, California 94560

 

Attention: General Counsel

 

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

 



 

CERTAIN MATERIAL (INDICATED BY [***]) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

LICENSE AGREEMENT (U.S.)

 

between

 

GRÜNENTHAL GMBH

 

and

 

JANSSEN PHARMACEUTICALS, INC.

 

and

 

JANSSEN RESEARCH & DEVELOPMENT, LLC

 

Index

 

 

Page(s)

LICENSE AGREEMENT (U.S.)

 

RECITALS

1

ARTICLE 1 — DEFINITIONS

3

ARTICLE 2 — LICENSE GRANTS

17

2.1

Licenses to OMP

17

(a)

Licenses for Commercialization

17

(b)

Licenses for Production

18

(c)

License for Regulatory Approval Preparation

18

(d)

Licenses for Improvement Patents Outside the Field

18

(e)

Payment for Licenses

19

(f)

Right to Sublicense

19

2.2

Licenses to Grünenthal

19

(a)

Licenses for Commercialization

19

(b)

Licenses for Production

19

(c)

License for Regulatory Approval Preparation

19

 

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

 



 

(d)

Payment for Licenses

20

(e)

[Reserved]

20

(f)

Right to Sublicense

20

2. 3

Conversion of Licenses to OMP to Non-exclusive license

20

ARTICLE 3 — MANUFACTURE

21

3.1.

Manufacturing by the Parties

21

3.2.

Transfer of Manufacturing Know-How

21

3.3.

Exchange of Manufacturing Know-How

21

ARTICLE 4 — COMMERCIALIZATION

22

4.1

Commercialization Efforts

22

4.2

Pricing

22

4.3

Marketing Responsibilities/Marketing Materials

22

(a)

In General

22

(b)

Party Name on Product Promotional Materials

22

4.4

Minimum Royalties in the OMP Territory

23

4.5

Promotion Compliance Responsibilities

25

4.6

Distribution

26

(a)

Customer Support

26

(b)

Recalls

26

4.7

[Reserved]

27

4.8

Contract to Supra National Agencies

27

ARTICLE 5 - TRADEMARK AND APPEARANCE

27

ARTICLE 6 — PAYMENTS

28

6.1

Considerations of OMP to Grünenthal

28

(a)

Upfront Payments for OMP Territory

28

(b)

Milestone Payments in connection with the OMP Territory

28

(c)

Payments in connection with RAP Plan 1.63.1 and OMP Territory Earned Royalty Payments

29

(d)

[Reserved]

29

 

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

 



 

(e)

[Reserved]

29

(f)

Proportionate Share

30

6.2

Payment of RAP Costs

30

(i)

Cost overruns

31

(ii)

Records and Audits

31

6.3

Earned Royalties for Products in OMP Territory

32

6.4

Royalties for Combination Products in OMP Territory

33

6.5

Royalty Calculation Method

34

6.6

[Reserved]

34

6.7

[Reserved]

34

6.8

Royalty Rate Reduction

34

(a)

Third Party Patents

34

(b)

Compulsory License

34

(c)

Competition in OMP Territory

35

(d)

[Reserved]

36

(e)

Royalties on Know-How of a Product containing CG-5503 as the sole active pharmaceutical ingredient

36

(f)

Royalties on Know-How of Combination Products

36

(g)

Royalty Rock Bottom

37

6.9

Cost of Goods Sold Cap (“COGS Cap”) in OMP Territory

37

6.10

Minimum Royalties

38

6.11

Term for Royalty Payment

38

6.12

Royalty Reports and Records

39

6.13

Taxes

41

6.14

Grünenthal As Licensee

41

6.15

Remittance

41

6.16

No Overlapping Royalties

42

6.17

Payments to or Reports by Affiliates

42

ARTICLE 7— IMPROVEMENT/OWNERSHIP OF INTELLECTUAL PROPERTY

42

7.1

Ownership of Intellectual Property and Patent Rights on Combined Territories License Agreement Effective Date

42

 

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

 



 

7.2

Maintenance of Grünenthal Background Patent

42

7.3

Disclosure of Improvements

42

7.4.

Ownership of Improvement Patents and Improvements

42

7.5

Filing of Improvement Patents

43

7.6

Extensions

43

7.7

Ownership of ADF-Formulation Patents and ADF-Formulation Improvements

44

7.8

Notice

45

7.9

Infringement Claims Against Third Parties

45

7.10

Assistance

45

7.11

Third Party Patents

45

7.12

Notices Relating to the Act

45

7.13

Authorization Relating to Patent Term Extension

46

7.14

Trade Secrets

47

ARTICLE 8— CONFIDENTIALITY

47

8.1

Confidentiality Exceptions

47

8.2

Authorized Disclosure

48

8.3

Survival

49

8.4

Publications

49

8.5

Public Announcements

49

ARTICLE 9 — REPRESENTATIONS AND WARRANTIES

50

9.1

Representations and Warranties

50

9.2

Grünenthal Patent Warranty

51

9.3

Grünenthal Product Warranty

51

9.4

OMP Diligence Warranty

51

9.5

OMP Patent Warranty

51

9.6

No Conflicting Rights

52

9.7

No Other Representations or Warranties

52

9.8

No Liability for Consequential Damages

52

 

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

 



 

ARTICLE 10 — MANAGEMENT OF REGULATORY APPROVAL PREPARATION (“RAP”) AND COMMERCIALIZATION

52

10.1

Steering Committee

52

(a)

Establishment of Steering Committee

53

(b)

Authority

53

(c)

Delegation

53

(d)

SC Responsibilities

53

(e)

Dispute Resolution

53

10.2

Final Decision-Making/Disputes RAP Matters

54

10.3

RAP Sub-Committee

55

(a)

Establishment of RSC

55

(b)

RSC Responsibilities

55

(c)

RSC Decision-making

56

(d)

Accounting/Financial Reporting

56

(e)

RSC Reporting

56

10.4

Commercialization Team

56

(a)

Formation of the Commercialization Team

56

(b)

Dispute Resolution

57

ARTICLE 11 — REGULATORY APPROVAL PREPARATION ( RAP”)

57

11.1

RAP Plans

57

(a)

RAP Plans

57

(b)

RAP Plan Modifications

57

11.2

Exclusive RAP Relationship

58

11.3

RAP Efforts

58

11.4

RAP Responsibilities

58

11.5

Clinical Trials

59

11.6

INDs and Drug Approval Applications

62

11.7

Regulatory Meetings and Communications

66

11.8

Territory Specific RAP Cost s

67

11.9

Transfer of Materials

68

 

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

 



 

11.10

Compliance with GLP/GCP/GMP

69

11.11

Failure to perform Duties of RAP Plan

69

11.12

Combination Products and Products based on Improvements

70

ARTICLE 12 — ADF FORMULATION

70

12.1

Decision of an abuse deterrent form ( ADF” ) Formulation

70

12.2

Development of ADF Formulation

72

12.3

Miscellaneous

76

12.4

Licenses for Independent ADF Formulation Improvement Patents controlled by OMP and Grünenthal ADF Formulation Patents

78

ARTICLE 13 — INDEMNIFICATION

78

13.1

Indemnification

78

13.2

Indemnification Procedures

79

13.3

Insurance

79

ARTICLE 14 — [Reserved]

80

ARTICLE 15 - TERM AND TERMINATION

80

15.1

Term

80

15.2

Termination For Breach

82

15.3

Termination For Bankru ptcy

83

15.4

[Reserved]

84

15.5

Termination After the Start of Phase III

84

15.6

Termination By OMP

87

15.7

Mutual Termination

89

15.8

Change of Control

89

(a)

In the event of a Change of Control of OMP

90

(b)

In the event of a Change of Control of Grünenthal

90

15.9

[Reserved]

90

 

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

 



 

15.10

Surviving Rights

90

15.11

Accrued Rights, Surviving Obligations

90

15.12

[Reserved]

91

15.13

Termination Not Sole Remedy

91

ARTICLE 16 — DISPUTE RESOLUTION

91

16.1

Dispute Resolution and Arbitration

91

16.2

Arbitration

91

ARTICLE 17 — [Reserved]

92

ARTICLE 18 — MISCELLANEOUS

92

18.1

Relationship of Parties

92

18.2

Counterparts

93

18.3

Headings

93

18.4

Binding Effect

93

18.5

Assignment

93

18.6

Amendment

93

18.7

Gov erning Law

93

18.8

Severability

94

18.9

Entire Agreement

94

18.10

Advice of Counsel

94

18.11

Consents Not Unreasonably With held

94

18.12

Retained Rights

95

18.13

Force Majeure

95

18.14

Further Actions

95

18.15

No Implied Licenses

95

18.16

Notices

96

18.17

Waiver

96

18.18

Compliance w ith Laws

96

18.19

Bankruptcy

97

18.20

Non-Solicitation

97

18.21

Contradictions

98

 

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

 



 

ARTICLE 19 — GUARANTEE OF JOHNSON & JOHNSON, JOINT AND SEVERAL LIABILITY

98

19.1

 

98

19.2

 

98

 

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

 



 

EXHIBITS AND SIDE LETTERS

EXHIBITS

1.3

CG-5503

1.22

Fully Allocated Manufacturing Costs

1.29

Grünenthal Background Patents

1.63

Initial Regulatory Approval Preparation Plan

1.63.1

Additional Regulatory Approval Preparation Plan

6.5

Calculation of OMP Territory Earned Royalty

10.3 (b)

Cost Allocation Principles

11.6 (a), 1

FDA Form 1571 and Attachment for Section 13

11.6 (a), 2

Grünenthal IND Transfer Letter

11.6 (a), 3

J&J PRD IND Acceptance Letter

11.7(c)

Adverse Event Reporting Procedures for Product

SIDE LETTERS

1

Supply of CG-5503 for Evaluation of ADF-Formulation

2

Exchange of Data/Information via IntraLinks

3

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-2001)

4

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-2003)

5a

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-007 (J&JPRD) / HP5503/14 (Grünenthal))

5b

Agreement to Approach NPS Pharmaceuticals re U.S. Patent 6,071,970

6

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1005 (J&JPRD); HP5503/13 (Grünenthal))

7

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1002 (J&JPRD); HP5503/16 (Grünenthal), Protocol R331333-PAI-1006 (J&JPRD); HP5503/15 (Grünenthal) and Protocol R331333-PAI-1009 (J&JPRD); HP5503/20 (Grünenthal))

8

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1003 (J&JPRD); HP5503/17 (Grünenthal) and Protocol R331333-PAI-1004 (J&JPRD); HP5503/18 (Grünenthal))

9

Disclosure of Confidential Information to OMP Affiliates

10

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1010 (J&JPRD); HP5503/21 (Grünenthal))

11

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1016 (J&JPRD); HP5503/24 (Grünenthal))

12

Delegation of Sponsorship to J&JPRD (Protocol R331333-PAI-1011 (J&JPRD); HP5503/22 (Grünenthal))

13

KF5503/24 (Title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase Ill Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects with Chronic Pain); Clinical trial sponsored by J&J PRD, to be conducted in countries of the Grünenthal Territory

14

Clinical trials conducted by J&J PRD in countries of the Grünenthal Territory (namely Phase 1 studies and studies belonging to the ACUTE part of the program)

 

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

 



 

 

15

KF5503/16 (Title: A randomized withdrawal, active- and placebo-controlled, double-blind, multicenter Phase III trial assessing safety and efficacy of oral CG5503 PR* in subjects with moderate to sever chronic malignant tumor-related pain); Clinical trial sponsored by J&J PRD, to be conducted in countries of the J&J and the Grünenthal Territory

16a

KF5503/37; R331333-PAI-3017 (Title: A randomized, double-blind, parallel-group, multi-center, active- and placebo-controlled trial to evaluate the analgesic efficacy and safety of multiple doses of CG5503 IR for postoperative pain following bunionectomy); Clinical trial sponsored by Grünenthal and conducted in countries of the OMP Territory

16b

KF5503/38; R331333-PAI-3018 (Title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Paid From Bunionectomy); Clinical trial sponsored by J&J PRD and conducted in countries of the OMP Territory

17

Clinical Studies using Laser and Mechano-Somatosensory Evoked Potentials

18

Clinical Trial HP5503/62 Evaluation of the safety, tolerability and pharmacokinetics of a 100 mg tapentadol tamper-resistant prolonged-release tablet when the formulation is subjected to mastication compared to 100 mg tapentadol IR tablets swallowed intact in a population of healthy subjects; Clinical trial sponsored by J&J PRD, to be conducted in countries of the Grünenthal Territory

19

KF5503/59; R331333PAI2005: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years, a clinical trial sponsored by J&JPRD, to be conducted in France as a country of the Grünenthal Territory, as well as in the United States, a country of the J&JPRD territory.

20

KF5503/62: A randomized, double-blind, placebo-controlled parallel group, multi-center trial to evaluate the efficacy and safety of multiple dose administration of an intravenous formulation of tapentadol in the treatment of acute pain following bunionectomy

21

KF5503/65; PAI3037: A evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old, a clinical trial sponsored by Janssen Research & Development, LLC (JRD), operational lead Grünenthal (GRT), to be conducted in countries of the Janssen Territory and Grünenthal Territory

 

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

 



 

LICENSE AGREEMENT (U.S.)

 

BETWEEN

 

GRÜNENTHAL GMBH

 

AND

 

JANSSEN PHARMACEUTICALS, INC.,

 

AND

 

JANSSEN RESEARCH &  DEVELOPMENT, LLC

 

This License Agreement (U.S.) (the “ Agreement’ ) is made by and between

 

Grünenthal GmbH, a German corporation having a principal place of business at Zieglerstraße 6, 52078 Aachen, mailing address 52099 Aachen, Germany ( Grünenthal ),

 

Janssen Pharmaceuticals, Inc. (successor in interest to Ortho-McNeil Pharmaceutical, Inc.), a Delaware corporation having a principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey, 08560 ( Ortho ),

 

Janssen Research & Development, LLC, having a principal place of business at U.S. Route 202, Raritan, NJ 08869 ( J&J PRD ) (Ortho and J&J PRD hereinafter collectively “ OMP ), and

 

Johnson & Johnson, having a principal place of business at One Johnson & Johnson Plaza, New Brunswick, NJ 08933 (“ Johnson & Johnson ”) as guarantor according to Article 19 of the Agreement.

 

Grünenthal and OMP may be referred to individually herein as a “Party” or together as the “ Parties .

 

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

 



 

RECITALS

 

1.                                      The Parties have previously entered into a License Agreement dated February 21, 2003, which License Agreement was amended as of December 23, 2004 and June 21, 2006 and then amended and restated in its entirety in an Amended and Restated License Agreement dated December 28, 2006, which Amended and Restated License Agreement was amended as of June 19, 2007, December 17, 2008, January 16, 2009, May 22, 2009, July 15, 2010 and May 29, 2013 (such Amended and Restated License Agreement, together with all amendments thereto, the “ Combined Territories License Agreement ”).

 

2.                                      The Combined Territories License Agreement granted certain licenses to OMP for Commercialization, Production, Regulatory Approval Preparation, Improvement Patents outside the Field and the right to sublicense for the United States, Canada and Japan.

 

4.                                       The Parties have decided to separate the territories to which OMP received rights under the Combined Territories License Agreement and to amend and restate the Combined Territories License Agreement in two separate license agreements: this Agreement, relating to rights and obligations in the United States, and the Canada/Japan License Agreement (the Canada/Japan License Agreement ”) , relating to rights and obligations in Canada and Japan.

 

NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree to amend and restate the Parties’ rights and obligations under the Combined Territories License Agreement with respect to the United States as follows:

 

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

 



 

LICENSE

 

AGREEMENT (U.S.)

 

between

 

GRÜNENTHAL GMBH

 

and

 

JANSSEN PHARMACEUTICALS, INC.

 

and

 

JANSSEN RESEARCH & DEVELOPMENT, LLC

 

January 13, 2015

 

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

 



 

LICENSE AGREEMENT (U.S.)

 

This License Agreement (U.S.) (this “ Agreement ) is effective as of January 13, 2015 (the “ Effective Date ”) by and between Grünenthal GmbH, a German corporation having a principal place of business at Zieglerstraße 6, 52078 Aachen, mailing address 52099 Aachen, Germany ( Grünenthal ), Janssen Pharmaceuticals, Inc., a Delaware corporation having a principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey, 08560, and Janssen Research and Development LLC, having a principal place of business at U.S. Route 202, Raritan, NJ 08869 (hereinafter collectively “ OMP ).

 

Grünenthal and OMP may be referred to individually herein as a “ Party or together as the “ Parties .

 

Terms not otherwise defined shall have the meaning ascribed to such terms in Article 1 of this Agreement.

 

a.                    RECITALS

 

1.                                 Grünenthal has screened in a [***] program more than [***] compounds and has identified CG-5503 (hereinafter defined) as an interesting drug candidate.

 

2.                                 Grünenthal has the sole and exclusive ownership of certain Patents claiming CG-5503.

 

3.                                 Grünenthal has conducted in-vitro and in-vivo testing of CG-5503 and has conducted comprehensive pre-clinical, pharmacology, safety pharmacology toxicology tests of CG-5503.

 

4.                                 Grünenthal has completed development of an iv, oral and oral slow-release formulation of CG-5503 and all necessary trials to establish proof of principle.

 

5.                                 Grünenthal was the IND holder in the United States for the Product (hereinafter defined) and established in consultation with the FDA a testing schedule for the Product and conducted Phase I and Phase II clinical trials. The IND in the United States was transferred to OMP prior to the Effective Date.

 

6.                                 Grünenthal has set up a clinical trial plan in order to obtain Regulatory Approval at approximately the same time in the United States and in the EU.

 

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

 

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7.                                 Grünenthal has to comply with the ICH Guidelines and Helsinki Declaration which seek to minimize the number of patients exposed to non-registered new drugs by not duplicating clinical trials in different regions of the world.

 

8.                                 Grünenthal wants to ensure that the clinical trial plan for the Product in the USA and Canada and the EU is carried out on a consistent and comprehensive basis with a view to ensuring that the necessary Regulatory Approvals are obtained as early as practicable using the best available resources and facilities and in the most efficient and economic manner.

 

9.                                 Grünenthal aims to Commercialize, by itself or through licensees, Product on a world-wide basis, but at the time of execution of the original Combined Territories License Agreement had no sales organization in the United States.

 

10.                          OMP has considerable experience in marketing, promotion, manufacturing and obtaining Regulatory Approvals for pain products in the United States.

 

11.                          Accordingly, Grünenthal wishes to grant to OMP, and OMP wishes to obtain from Grünenthal, a license to make, use and sell the Product in the United States.

 

12.                          Grünenthal seeks to ensure that it manages the global risk benefit analysis for the Product by pooling all global efficacy and safety data and presenting such to all relevant registration authorities, while acknowledging that certain Regulatory Authorities require studies to be conducted in their specific country.

 

13.                          In order to comply with all applicable regulatory rules and regulations and in order to obtain and maintain Regulatory Approvals, Grünenthal and OMP and its Affiliates in their respective Territories have concluded a separate pharmacovigilance agreement.to coordinate their activities, including, but not limited to adverse event reporting.

 

14.                          Within the clinical trial plan for achieving Regulatory Approval in the US and the EU which has been developed by Grünenthal and subsequently co-developed by OMP and Grünenthal, Grünenthal is prepared to allocate to, and OMP is prepared to accept, certain responsibilities and activities pertaining to the clinical trial plan so that the Product may be successfully Commercialized by each Party independently in their respective Territories.

 

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

 

2



 

15.                                              OMP as licensee for the United States, representing approximately [***] of the world market, is prepared to contribute to the resources and costs of the Regulatory Approval Preparation by bearing [***] of such resources and costs.

 

16.                                              OMP´s contribution to the Regulatory Approval Preparation is a substantial part of the consideration for the licenses being granted hereunder apart from upfront payments, milestone payments and royalty payments.

 

17.                                              OMP and Grünenthal have agreed jointly to develop the Grünenthal-ADF-Formulation.

 

NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

 

ARTICLE 1                            DEFINITIONS

 

1.1                               ADF Formulation ” means an abuse deterrent formulation or drug delivery system of the Product developed in accordance with RAP Plan 1.62 which includes the OMP-ADF-Formulation and the Grünenthal-ADF-Formulation, which through any of its physical, mechanical, chemical, pharmacokinetic, pharmacodynamic properties, has the potential to reduce abuse, diversion, or other inappropriate use of CG-5503.

 

1.2                               Affiliate ” means, with respect to any person or entity, any other person or entity which controls, is controlled by or is under common control with such person or entity. A person or entity shall be regarded as in control of another entity if it owns or controls directly or indirectly at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority).

 

1.3                               CG-5503 ” means any composition of matter specified on Exhibit 1.3 .

 

1.4                               Combination Product ” means a pharmaceutical Product containing CG-5503 in combination with one or more other active pharmaceutical ingredient(s) but excluding New Chemical Entities.

 

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

 

3



 

1.5                               Combination Product Market Exclusivity ” means on a country-by-country basis, the period of time during which, besides the respective Combination Product sold by OMP, there is no other combination product containing CG-5503 in combination with the same active pharmaceutical ingredient(s) being sold by a Third Party, other than Affiliates, in the OMP Territory, excluding such combination product containing CG-5503 from such Third Parties for which claims of infringement according to Section 7.9 have not led to a final, non-appealable decision of a court and claims of infringement are continuing to be pursued in court.

 

1.6                              Combined Territories License Agreement Effective Date ” means February 21, 2003.

 

1.7                               Commercialization ” means any and all activities constituting, using, importing, marketing, distributing, promoting, offering for sale, selling and having sold a Product. When used as a verb, “Commercialize” shall mean to engage in Commercialization.

 

1.8                               Commercialization Team ” or “ CT ” shall have the meaning recited in Section  10.4 .

 

1.9                               Commercially Reasonable and Diligent Efforts means those efforts and resources normally used in the pharmaceutical business by [***] pharmaceutical companies for a product or compound owned by it or to which it has rights, which is of similar market potential at a similar stage in its development or product life, taking into account, without limitation, issues of safety and efficacy, product profile, pricing and reimbursement status, the proprietary position of, as applicable, CG-5503 in comparison to other products in a Party’s product portfolio, the then prevailing regulatory environment and status with respect thereto, and relevant scientific and commercial factors.

 

1.10                        Control ” or “ Controlled ” means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangements with any Third Party. “Control” expressly includes the right of ownership, in whole or by more than fifty percent (50%).

 

1.11                        Core Regulatory Approval Preparation Program ” or “ Core RAP Program ” means the development program for the Product designed to generate all preclinical, clinical and regulatory information required for filing Drug Approval Applications in the United States, Canada, the EU and Japan. Territory Specific Regulatory Approval Preparation for countries not listed in this definition is not part of the Core Regulatory Approval Preparation Program, unless the Parties mutually agree as recited in Section 11.8 .

 

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

 

4



 

1.12                        Cost of Goods Sold ” or “ COGS ” means the Fully Allocated Manufacturing Costs of Product sold plus any royalties paid on such Product under Article 6 .

 

1.13                        Drug Approval Application ” means any application for Regulatory Approval required before commercial sale or use of a Product as a drug, biologic or therapeutic in a regulatory jurisdiction including, without limitation, reimbursement approvals.

 

1.14                        EMEA ” means the European Agency for the Evaluation of Medicinal Products and any successor agency.

 

1.15                        EU ” means the supra national community consisting of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom of Great Britain and Northern Ireland and all other countries which after the Combined Territories License Agreement Effective Date become part of this supra national community. In addition and only for the purpose of this Agreement, Switzerland and the present and future European Economic Area countries (at present: Liechtenstein, Iceland and Norway) shall form part of this definition.

 

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

 

1.17                        Field ” means the Regulatory Approval Preparation, use, manufacture, distribution, marketing and sale of Products for the [***].

 

1.18                        First Commercial Sale ” means, with respect to a given Product, the first sale in an arms length transaction and shipment of a Product to a Third Party other than an Affiliate by OMP in a country in the OMP Territory following applicable Regulatory Approval of the Product in such country.

 

1.19                        FTE ” means a full time scientific person dedicated with appropriate credentials and training to the Regulatory Approval Preparation Plan, or in the

 

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

 

5



 

case of less than a full-time dedicated scientific person, a full-time, equivalent scientific person year, based upon [***].

 

1.20                        Fully Allocated Manufacturing Costs ” shall be as defined in Exhibit 1.22 .

 

1.21                        GCP ” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH (as defined below) guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the EU and other organizations and/or governmental agencies in countries in which a Product is intended to be sold, to the extent such standards are not less stringent than United States or EU GCP.

 

1.22                        GLP ” means the then current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s GLP regulations and/or the GLP principles of the Organization for Economic Co-operation and Regulatory Approval Preparation (OECD), as amended from time to time, and such standards of good laboratory practice as are required by the EU and other organizations and/or governmental agencies in countries in which a Product is intended to be sold, to the extent such standards are not less stringent than United States or EU GLP.

 

1.23                        GMP ” means (i) the regulatory requirements for current good manufacturing practices promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act, 21 C.F.R. § 210 et seq. (“ FD&C Act ”) and under the Public Health Service Act, Biological Products, 21 C.F.R. §§ 600-610 (“ PHS Act ”), as the same may be amended from time to time; and (ii) such standards of good manufacturing practice as are required by the EU and other organizations and/or governmental agencies in countries in which a Product is intended to be manufactured or sold, to the extent such standards are not less stringent than United States or EU GMP. Bulk development (active pharmaceutical ingredient “ API ”) and commercial manufacturing will comply with the current ICH Q7A guidelines. During development phase, the clinical supplies for studies conducted in the US will comply with cGMP according to FDA. For

 

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

 

6



 

studies conducted in the EU, clinical supplies will comply with annex 13 of the EU GMP guideline.

 

1.24                        Grünenthal-ADF-Formulation ” means any formulation or drug delivery system which is a ADF Formulation useful for delivery of CG-5503 including, but not limited to, sustained release matrix tablet formulations of the Product and other formulations or drug delivery systems developed by or for Grünenthal based on Grünenthal technology or Grünenthal Know-How but specifically excluding an OMP-ADF-Formulation.

 

1.25                        Grünenthal-ADF-Formulation Patent ” means any Patent Controlled by Grünenthal and claiming a Grünenthal-ADF-Formulation and/or Grünenthal-ADF-Formulation Improvement.

 

1.26                        Grünenthal Know-How ” means Information which (i) Grünenthal discloses to OMP under this Agreement or specifically in anticipation of this Agreement; and (ii) is within the Control of Grünenthal, and (iii) is confidential as defined in Article 8 .

 

1.27                        Grünenthal Background Patent ” means any Patent filed, published or issued as of the Combined Territories License Agreement Effective Date relevant or pertaining to the Field which is directed to, but is not limited to, a method, apparatus, material, process of manufacture or use of CG-5503 or Product and which Patent is Controlled by Grünenthal or its Affiliates on the Combined Territories License Agreement Effective Date, however, not including Grünenthal-ADF-Formulation Patents. Grünenthal Background Patents include those listed in Exhibit 1.29 .

 

1.28                        Grünenthal Patents ” means Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and Grünenthal-ADF-Formulation Patents.

 

1.29                        Grünenthal Territory ” means every country or political subdivision in the world, with the exception of OMP Territory.

 

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

 

7



 

1.30                        ICH ” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

 

1.31                        Improvement ” means any improvement, enhancement or invention conceived and/or reduced to practice, as a result of activities carried out in connection with RAP, Commercialization or manufacture of Product, by employees or agents of the Parties or a Third Party under a contract with either Party or an Affiliate of either Party during the Term of this Agreement directed to CG-5503, Product or Combination Products, but explicitly excluding OMP Technology or ADF-Formulations.

 

1.32                        Improvement Patents ” means any Patent claiming an Improvement.

 

1.33                        IND ” means an investigational new drug application filed with the FDA as more fully defined in 21 C.F.R. §312.3 and in EU clinical trial authorisation (CTA) or its equivalent in any country.

 

1.34                        Information ” means all information including screens, models, inventions, practices, methods, knowledge, know-how, skill, experience, test data including pharmacological, toxicological and clinical test data, analytical and quality control data and preliminary and final reports thereof, marketing, pricing, distribution, costs, sales, manufacturing data, and patent and legal data or descriptions (to the extent that disclosure thereof would result in loss or waiver of privilege or similar protection) and methods in each case relating to CG-5503 and/or the Product.

 

1.35                        Management Committee ” or “ MC ” means a team consisting of the managing director responsible for research and development at Grünenthal and the President of research and development of OMP’s Affiliate, Johnson & Johnson Pharmaceutical Research and Development, LLC.

 

1.36                        Market Exclusivity ” means, on a country-by-country basis, the period of time during which there is no product containing CG-5503 being sold by a Third Party, other than Affiliates, in the OMP Territory, excluding such product containing CG-5503 from such Third Parties for which claims of infringement

 

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

 

8



 

according to Section 7.9 have not led to a final, non-appealable decision of a court and such claims of infringement are continuing to be pursued in court.

 

1.37                        NDA ” means a new drug application and all supplements filed pursuant to the requirements of the FDA, including all documents, data and other information concerning Product which are necessary for or included in, FDA approval to market a Product as more fully defined in 21 C.F.R. §314.50 et. seq.

 

1.38                        Net Sales ” means the gross amount billed, as of the date of invoicing, by OMP or an Affiliate of OMP for sales of a Product to a Third Party which is other than an Affiliate less: to the extent actually allowed or taken for the OMP Territory

 

(a)                                  normal and customary discounts, including cash discounts, discounts to managed care or similar organizations or government organizations, rebates paid, credited, accrued or actually taken, including government rebates such as Medicaid chargebacks or rebates, and retroactive price reductions or allowances actually allowed or granted from the billed amount, and commercially reasonable and customary fees paid to distributors (other than to a distributor that is an Affiliate of OMP),

 

(b)                                  credits or allowances actually granted upon claims, rejections or returns of such sales of Products, including recalls, regardless of OMP requesting such recalls,

 

(c)                                   freight, postage, shipping and insurance charges paid for delivery of such Product, to the extent billed separately on the invoice and paid by the buyer, and

 

(d)                                  taxes, duties or other governmental charges levied on or measured by the billing amount when included in billing, as adjusted for rebates, charge-backs and refunds to the extent actually paid or allowed by the selling party; and

 

(e)                                   actual uncollectible accounts receivables determined in accordance with U.S. generally accepted accounting practices, consistently applied.

 

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

 

9



 

1.39                       New Chemical Entity ” means a chemical entity which has or is claimed to have therapeutic activity and is claimed in a composition of matter Patent in the United States or EU.

 

1.40                        OMP-ADF-Formulation ” means any formulation or drug delivery system which is an ADF Formulation useful for the delivery of CG-5503 developed by or for OMP including, but not limited to, ADF Formulations based on OMP Technology, but specifically excluding a Grünenthal-ADF-Formulation.

 

1.41                        OMP-ADF-Formulation Patent ” means any Patent Controlled by OMP and/or its Affiliates claiming an OMP-ADF-Formulation and/or OMP-ADF-Formulation Improvement.

 

1.42                        OMP Know-How ” means Information which (i) OMP discloses to Grünenthal under this Agreement or specifically in anticipation of this Agreement; and (ii) is within the Control of OMP, and (iii) is confidential as defined in Article 8 .

 

1.43                        OMP Patent ” means any Patent filed, published or issued as of the Combined Territories License Agreement Effective Date, which Patent is Controlled by OMP and/or its Affiliates which would be infringed by the manufacture, use or sale of the Product, and OMP ADF-Formulation Patents and Improvement Patents Controlled by OMP or its Affiliates.

 

1.44                        OMP Technology ” means an osmotic system for oral administration which is intended to function by releasing the active agent or agents on a controlled basis within the human gastrointestinal tract after being swallowed, or any component of such system to the extent it is used in the system, and which is Controlled by OMP or its Affiliates.

 

1.45                        OMP Territory ” shall mean the United States.

 

1.46                        OOP ” means out of pocket expenses related to the Regulatory Approval Preparation Plan and paid to Third Parties.

 

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

 

10



 

1.47                        Patent ” means any issued patents, patent applications and patents issuing therefrom, together with any extensions, registrations, confirmations, reissues, continuations, divisions, continuations-in-part, reexaminations, substitutions or renewals thereof.

 

1.48                        Phase I ” means the portion of the clinical program which provides for the first introduction into humans of a Product including small scale clinical studies conducted in normal volunteers or patients to obtain information relating to Product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. 312.21 (a) and such definitions as used by the EU and other organizations and governmental agencies in countries in which the Product is intended to be tested.

 

1.49                        Phase II ” means that portion of the clinical program which provides for the definitive, well controlled clinical trials of the Product in patients, including clinical studies conducted in patients and designated to indicate clinical efficacy safety, as well as to obtain an indication of the dosage regimen required as more fully defined in 21 C.F. R. 312.21(b) and such definitions as used by the EU and other organizations and governmental agencies in countries in which the Product is intended to be tested.

 

1.50                        Phase III ” means that portion of the clinical program which provides for large scale clinical studies conducted in a sufficient number of patients to establish Product clinical efficacy for one or more indications and its safety, as more fully defined in 21 C.F.R. 312.21 (c) and such definitions as used by the EU and other organizations and governmental agencies in countries in which the Product is intended to be tested.

 

1.51                        Phase IIIB ” means product support clinic trials of a Product commenced after the first Drug Approval Application is filed in the United States or the EU, which trials are directed to seeking Regulatory Approval for additional label claims.

 

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

 

11



 

1.52                        Phase IV ” means product support clinical trials of a Product with an approved label claim commenced after receipt of Regulatory Approval for such Product in the country where such trial is being conducted.

 

1.53                        Product ” means any pharmaceutical formulations for all and any human use within the Field containing CG-5503 as active pharmaceutical ingredient including Combination Product, but excluding combinations of CG-5503 with one or more New Chemical Entities.

 

1.54                        Promotion ” means those activities, including, without limitation, congresses, opinion leader management, physicians meeting, professional education, detailing, advertising and distributing samples of a Product normally undertaken by a pharmaceutical company’s sales force to implement marketing plans and strategies aimed at encouraging the appropriate use of a particular Product. When used as a verb, “Promote” shall mean to engage in Promotion.

 

1.55                        Proportionate Share ” shall have the meaning set forth in Section 6.1(f) .

 

1.56                        Regulatory Approval ” means all official approvals by government, pricing, health or drug evaluation authorities (such as National Institute for Clinical Excellence in UK or Commission de Transparence in France) in a country (or supra-national organizations, such as the EMEA) which are required for first use or sale, including, importation, manufacture (where manufacture is required), pricing or reimbursement of a pharmaceutical product in such country where required.

 

1.57                       Regulatory Approval Preparation ” or “ RAP ” means all activities performed by or on behalf of either Party with respect to a Product in the United States and the EU in connection with the Core Regulatory Approval Preparation Program or Core Pediatric Program necessary to obtain Regulatory Approval of a Product for the indication under study. “Regulatory Approval Preparation” shall include, without limitation, all activities related to clinical studies of a potential therapeutic in humans including, CM&C, preclinical testing, test

 

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

 

12



 

method development and stability testing, toxicology, pharmacokinetics, pharmacoeconomic studies, mechanism studies, quality assurance/quality control, clinical studies, clinical supplies, regulatory affairs, statistical analysis and report writing. When used as a verb, “ Prepare Regulatory Approval ” shall mean to engage in Regulatory Approval Preparation.

 

1.58                        Regulatory Approval Preparation Budget ” or “ RAP Budget ” means the budget to carry out the Core Regulatory Approval Preparation Program as contained in the Regulatory Approval Preparation Plan.

 

1.59                        Regulatory Approval Preparation Costs ” or “ RAP Costs ” means costs associated with Regulatory Approval Preparation of the Product according to the Core Regulatory Approval Preparation Program and as further defined in the Regulatory Approval Preparation Plan in Exhibit  1.63 and Exhibit 1.63.1 .

 

1.60                        Regulatory Approval Preparation Plan ” or “ RAP Plan ” means the plan and Regulatory Approval Preparation Budget describing the Core Regulatory Approval Preparation Program. An initial Regulatory Approval Preparation Plan is attached hereto as Exhibit 1.63 and incorporated herein. An additional Regulatory Approval Preparation Plan is attached hereto as Exhibit 1.63.1 and incorporated herein. All RAP Plans may be modified pursuant to Section 11.1(b) .

 

As for this Agreement and unless otherwise specified the term “ RAP Plan ” shall mean the RAP Plan 1.63 and the RAP Plan 1.63.1 and the respective plans within the Core Pediatric Program.

 

1.61                        RAP Subcommittee ” or “ RSC ” shall have the meaning recited in Section 10.3 .

 

1.62                        Regulatory Authority ” means any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMEA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval.

 

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

 

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1.63                        Steering Committee ” or “SC” shall have the meaning set forth in Section 10.1 .

 

1.64                        Term ” shall have the meaning set forth in Section 15.1 .

 

1.65                        Territory ” means those countries, possessions, or political subdivision within, as applicable, the OMP Territory or the Grünenthal Territory.

 

1.66                        Territory Specific Regulatory Approval Preparation ” or “ Territory Specific RAP ” is defined in Section 11.8 .

 

1.67                        Third Party ” means any entity other than Grünenthal and OMP.

 

1.68                        Trade Secret ” means an Improvement for which deliberately a patent application has not been filed and which is confidential according to Article 8 .

 

1.69                        United States ” means the United States of America, the District of Columbia and Puerto Rico.

 

1.70                        Valid Patent Claim ” means a claim in any unexpired Grünenthal Patent, which has not been held invalid by a non-appealed or unappealable decision by a court or other appropriate body of competent jurisdiction. The scope of a Valid Patent Claim shall be limited to its terms as set forth in the Patent itself and as further defined by any court, body or law of competent jurisdiction.

 

1.71                        Year of Sale ” means a 365 day (or 366 day in a leap year) period. The “First Year of Sale” means the Year of Sale beginning on the date of the First Commercial Sale and ending 365 days (or 366 days in a leap year) thereafter.

 

1.72                        Agreement ” means this License Agreement.

 

1.73                        2004 First Amendment ” means the amendment of the Combined Territories License Agreement effective as of December 23, 2004.

 

1.74                        1.63.1 ADF ” means an abuse deterrent formulation for the Product developed in accordance with RAP Plan 1.63.1.

 

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

 

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1.75                        1.63.1 Patents ” means any Patent Controlled by a Party and claiming a 1.63.1 ADF.

 

1.76                        Commercial Supply Manufacturing License ” shall have the meaning set forth in Section 2.1(b) .

 

1.77                        Earned Royalty ” means the OMP Territory Earned Royalty.

 

1.78                        Last Patent ” shall have the meaning set forth in Section 6.8(e) .

 

1.79                        Minimum Royalty for OMP Territory ” shall have the meaning set forth in Section 4.4(a) .

 

1.80                        Last Combo Patent ” shall have the meaning set forth in Section 6.8(f) .

 

1.81                        Minimum Royalty for OMP Territory ” shall have the meaning set forth in Section 4.4(a) .

 

1.82                        OMP Territory Earned Royalty ” shall have the meaning set forth in Section 6.4 .

 

1.83                        [Reserved]

 

1.84                        [Reserved]

 

1.85                        Responsible Party for Clinical Trials ” means the Party subsequently defined by mutual agreement of the Parties.

 

1.86                        Study KF5503/21 ” means the bunionectomy phase II b clinical study conducted prior to the Effective Date and referred to by the Parties as “Study KF5503/21.”

 

1.87                        [Reserved]

 

1.88                        Grünenthal-ADF-Formulation Improvements ” means any improvement, enhancement or invention, other than an Independent ADF Formulation Improvement, conceived and/or reduced to practice, as a result of activities carried out within the scope of any regulatory approval preparation activities

 

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

 

15



 

and the joint activities of Grünenthal and OMP for the development of the Grünenthal-ADF-Formulation, including but not limited to its manufacture and/or analytics based on Grünenthal technology and/or Grünenthal Know-How by employees or agents of the Parties or a Third Party under a contract with either Party or an Affiliate of either Party during the Term of this Agreement directed to Grünenthal-ADF-Formulation.

 

1.89                        OMP-ADF-Formulation Improvements ” means any improvement, enhancement or invention, other than an Independent ADF Formulation Improvement, conceived and/or reduced to practice, as a result of activities carried out within the scope of the RAP activities and the joint activities of Grünenthal and OMP for the development of the OMP-ADF-Formulation, including but not limited to its manufacture and/or analytics based on OMP technology and/or OMP Know-How by employees or agents of the Parties or a Third Party under a contract with either Party or an Affiliate of either Party during the Term of this Agreement directed to OMP-ADF-Formulation.

 

1.90                        Independent ADF Formulation Improvements” means any improvement, enhancement or invention conceived and/or reduced to practice, by employees or agents of only one of the Parties or a Third Party under a contract with only one of the Parties or an Affiliate of only one of the Parties during the Term of this Agreement outside the scope of the RAP activities and the joint activities of Grünenthal and OMP for the development of an ADF Formulation as such party can prove by written records and thereafter introduced by such Party into the joint development of a ADF Formulation for the Product under this Agreement which improvement can be used in making not only an ADF Formulation but which can also be used in making other products including but not limited to its manufacture and/or analytics.

 

1.91                        Independent ADF Formulation Improvement Patent ” means any Patent claiming an Independent ADF Formulation Improvement.

 

1.92                        Phase IIIB2 ” means product support clinical trials of the Product other than Phase IIIB, commenced after the first Drug Approval Application is filed in the

 

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

 

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United States or the EU and prior to receipt of Regulatory Approval in the US or the EU.

 

1.93                        Core Pediatric Program ” means all pediatric program elements including preclinical and clinical studies, CM&C work packages and any activities for galenical forms necessary in both the OMP Territory and Grünenthal Territory for conducting clinical studies in pediatric patients, the results of which support Products resulting from either RAP Plan 1.63 and/ or 1.63.1. For the avoidance of doubt, any element necessary in only one Party’s Territory is not part of the Core Pediatric Program.

 

1.94                        Post Approval Commitments ” means a study or data collection effort mandated by the applicable Regulatory Authority as a condition of Regulatory Approval in the US or the EU.

 

1.95                        Risk Management Plan ” or “ RMP ” means a description of the product specific risk management system in addition to the general description of the pharmacovigilance system and more specific with regard to the EU the Guideline on Risk Management Systems for Medicinal Products for Human Use (EMENCHMP/96268/2005) and with regard to the United States FDA Guidance for Industry: Development and Use of Risk Minimization Action Plans, and a Risk Evaluation Mitigation and Strategy.

 

ARTICLE 2                            LICENSE GRANTS

 

2.1                               Licenses to OMP

 

(a)                                  Licenses for Commercialization. Grünenthal hereby grants to OMP an exclusive (even as to Grünenthal), royalty bearing, license, within the Field, under the Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and Grünenthal Know-How, to Commercialize Products within the OMP Territory. OMP shall have the right, to be exercised within [***] after receipt of the notice of an Improvement pursuant to Section 7.3 , to refuse to accept a license under know-how or patent rights resulting from such Improvement, or, if accepted, to terminate any such license at any time upon

 

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

 

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[***] written notice to Grünenthal. In addition, Grünenthal shall have no right to use, import, offer for sale, sell or distribute a product containing CG-5503 in the OMP Territory outside the Field, without the prior written consent of OMP, which shall not be unreasonably withheld. During the Term of this Agreement OMP shall not have any right to sell, offer for sale, distribute and have sold Product for any indication outside the Field or outside the OMP Territory, provided that the foregoing shall not be interpreted to diminish the rights of either Party pursuant to any other license agreement between OMP and Grunenthal, or their Affiliates. Grünenthal hereby grants to OMP a non-exclusive paid up license within OMP Territory within the Field under the Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and Grünenthal Know-How to use all Information obtained from Grünenthal’s activities conducted under RAP Plan 1.63 and RAP Plan 1.63.1 including Study KF5503/21 for OMP’s use in OMP Territory.

 

(b)                                  Licenses for Production . Grünenthal hereby grants to OMP a non-exclusive royalty bearing, license, within the Field under the Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and Grünenthal Know-How, to make or have made Products worldwide for the purpose of Commercialization of Products within the OMP Territory under the license for Commercialization granted under Section 2.1(a)  (“ Commercial Supply Manufacturing License ”).

 

(c)                                   Licenses For Regulatory Approval Preparation . Grünenthal hereby grants to OMP:

 

(i)                                      a non-exclusive, paid up worldwide license, within the Field, under the Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and Grünenthal Know-How for use in carrying out Regulatory Approval Preparation of the Product in the OMP Territory,

 

(ii)                                   Grünenthal hereby grants to OMP a non-exclusive, paid up license within OMP Territory within the Field under the Grünenthal Background Patents, Improvement Patents Controlled by Grünenthal and

 

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

 

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Grünenthal Know-How to use all Information obtained from Grünenthal’s activities conducted under RAP Plan 1.63 and RAP Plan 1.63.1 including Study KF 5503/21 for OMP’s use to obtain Regulatory Approval in OMP Territory.

 

(d)                                  Licenses for Improvement Patents outside the Field . According to Section 7.4 , Grünenthal shall own any Improvement Patent based on joint inventorship. In the situation wherein an employee, agent, officer, or contractor of OMP or OMP’s Affiliates is an inventor, Grünenthal grants to OMP a worldwide non-exclusive, paid-up license under all such Improvement Patents for use outside the Field.

 

(e)                                   Payment for Licenses . The royalties that are payable pursuant to this Section 2.1 are set forth in Article 6 .

 

(f)                                    Right to Sublicense . The licenses granted to OMP pursuant to this Section 2.1 include the right to sublicense to Affiliates of OMP.

 

2.2                      Licenses to Grünenthal

 

(a)                                  Licenses for Commercialization. OMP hereby grants to Grünenthal an non-exclusive, royalty bearing, license, within the Field under the Improvement Patents directed to Combination Products Controlled by OMP (“ Improvement Combination Patents ”) and OMP Know-How, to Commercialize Products within the Grünenthal Territory.  OMP hereby grants to Grünenthal a non-exclusive royalty free license within the Field under Improvement Patents Controlled by OMP other than Improvement Combination Patents to Commercialize Products within the Grünenthal Territory; provided, however, that Grünenthal shall be responsible for any payments due to a Third Party in the Grünenthal Territory under such Improvement Patents.

 

(b)                                  Licenses for Production. OMP hereby grants to Grünenthal a non-exclusive royalty bearing, license, within the Field under the Improvement Combination Patents and OMP Know-How, to make or have made Products worldwide solely for the purpose of Commercialization of Products within the Grünenthal

 

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

 

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Territory under the license for Commercialization granted under Section 2.2(a) . OMP hereby grants to Grünenthal a non-exclusive royalty free license within the Field under Improvement Patents other than Improvement Combination Patents to make or have made Products worldwide solely for the purpose of Commercialization of Products within the Grünenthal Territory under the license for Commercialization granted under Section 2.2(a) ; provided, however, that Grünenthal shall be responsible for any payment due to a Third Party in the Grünenthal Territory under such Improvement Patents.

 

(c)                                   Licenses For Regulatory Approval Preparation. (i) OMP hereby grants to Grünenthal a non-exclusive, paid up worldwide license, within the Field, under the Improvement Patents Controlled by OMP and OMP Know-How for use in carrying out Regulatory Approval Preparation of the Product in the Grünenthal Territory. (ii)  OMP hereby grants to Grünenthal an exclusive, paid up worldwide license to use all Information obtained from OMP’s activities conducted under RAP Plan 1.63 and 1.63.1 to obtain Regulatory Approval in Grünenthal Territory.

 

(d)                                  Payment for Licenses . The royalties that are payable pursuant to Section 2.2 are set forth in Section 6.4(c)  of this Agreement.

 

(e)                                   [Reserved]

 

(f)                                    Right to Sublicense . The licenses granted to Grünenthal pursuant to this Section 2.2 include the right to sublicense to Affiliates of Grünenthal or to licensees of Grünenthal.

 

2.3                               Conversion of License to OMP to Non-exclusive License .

 

(a)                                  For Products based on Improvement Patents Controlled by Grünenthal the exclusive rights granted in Sections 2.1(a)  shall be converted to a non-exclusive license upon the date OMP has provided notice according to Section 2.3(b)  to Grünenthal that OMP or a Third Party having rights from OMP will start Commercialization of a Product based on Improvement Patents in the Grünenthal Territory according to Section 2.2(a) .

 

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

 

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(b)                                  Notice to Grünenthal to enter market . OMP shall give Grünenthal [***] prior written notice before start of Commercialization of a Product based on Improvement Patent in the Grünenthal Territory (with specific reference to Section 2.3 ).

 

ARTICLE 3                            MANUFACTURE

 

3.1                               Manufacturing by the Parties . Grünenthal shall be responsible for the manufacture of the Product , including the manufacture of bulk active pharmaceutical ingredient and appropriate pharmaceutical formulation for the Grünenthal Territory. OMP shall be responsible for the manufacture of the Product, including the manufacture of bulk active pharmaceutical ingredient and appropriate pharmaceutical formulation, for the OMP Territory and have available the necessary and timely production capacity to supply OMP’s respective markets. Should the manufacturing at separate Grünenthal and OMP sites appear to be economically not feasible, the Parties agree to discuss a solution in good faith.

 

3.2                               Transfer of Manufacturing Know-How . Grünenthal shall supply OMP with the available manufacturing know-how and technical assistance to manufacture Product, including the Grünenthal (Non-ADF SR-Matrix, the Grünenthal formulation currently used in clinical trials) slow release formulation and/or Grünenthal-ADF-Formulation, if so decided by the Parties according to Section 12.1(b) , if OMP decides to Commercialize such formulation. Such transfer shall occur in sufficient time to enable the execution of respective activities of the Regulatory Approval Preparation Plan according to the timetables, recited therein, or the appropriate regulatory filings and commercial launch in OMP´s Territory.

 

3.3                               Exchange of Manufacturing Know-how. OMP and Grünenthal will exchange, on a regular and periodic basis, but in no event less than once per year, manufacturing know-how relating to the Product, including with respect to the manufacture of bulk active pharmaceutical ingredient and the ADF Formulation (provided both are manufacturing the same ADF Formulation)

 

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

 

21



 

and will give experts of the other Party sufficient opportunity to visit the production facility and to view the production process, under appropriate conditions of confidentiality. Significant improvements to the manufacturing process, however, will be communicated promptly to the other Party.

 

ARTICLE 4                            COMMERCIALIZATION

 

4.1                               Commercialization Efforts . OMP shall conduct all activities contemplated by this Agreement in a manner which does not cause any material injury to either the reputation of Grünenthal or to the goodwill of any Product sold in the Grünenthal Territory. Grünenthal shall conduct all activities contemplated by this Agreement in a manner which does not cause any material injury to either the reputation of OMP or to the goodwill of any Product sold in the OMP Territory. Activities contemplated by this Agreement taken due to drug safety concerns or pursuant to Section 4.2 shall not be considered to cause material injury as mentioned above.

 

4.2                               Pricing . OMP shall have sole decision authority and discretion with respect to all pricing decisions and reimbursement strategies relating to the OMP Territory. Grünenthal shall have sole decision authority and discretion with respect to all pricing decisions and reimbursement strategies relating to all countries in the Grünenthal Territory.

 

4.3                               Marketing Responsibilities/Marketing Materials

 

(a)                                  In General . With respect to the OMP Territory for OMP, and any EU country for Grünenthal, each Party shall provide to the other Party exemplars for each marketing and promotional platform or campaign for each Product contemporaneous with the implementation of such platform or campaign, provided, however, that no such submission shall be required where there is no material deviation from any prior submission.

 

(b)                                  Party Name on Product Promotional Materials . Grünenthal shall have the option to be exercised no later than [***] after OMP´s notice (with specific reference to this Section) to Grünenthal of OMP’s internal decision to file the

 

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

 

22



 

Drug Approval Application prior to the envisaged First Commercial Sale in the United States (to the extent permitted by the applicable laws and regulations of each country in which such Product promotional materials are to be presented), to require OMP to include on all Product promotional materials for Product sold in the OMP Territory the name and logo of Grünenthal and shall describe Grünenthal as being licensor of the Product and name and logo of OMP, or the appropriate Affiliate, under a format, style and size to be agreed between the Parties provided, however, that the font or, as applicable, the size to be used for Grünenthal’s name and logo shall be no less than fifty percent (50%) of the font or, as applicable, the size to be used for OMP or the appropriate Affiliate’s name and logo. To the extent permitted by the applicable Regulatory Authorities, Grünenthal will include on all promotional materials for Product using the OMP-ADF-Formulation sold in its Territory the names and logos of both Grünenthal and OMP, or the appropriate Affiliate and a logo designating the OMP Technology used in the OMP-ADF-Formulation, under a format, style and size to be agreed between the Parties; provided, however, that the font or, as applicable, the size to be used for OMP’s or the appropriate Affiliate’s name and logo shall be no less than fifty percent (50%) of the font or, as applicable, the size to be used for Grünenthal.

 

4.4                               Minimum Royalties in the OMP Territory

 

(a)                                  OMP Territory :

 

(i)                                      Subject to all terms and conditions of this Agreement, OMP shall have to pay for the Product sold in the OMP Territory, the following minimum royalties (“ Minimum Royalty for OMP Territory ”) in the OMP Territory beginning with the [***] Year of Sale and ending at the end of the [***] Year of Sale following First Commercial Sale in the OMP Territory pursuant to the Combined Territories License Agreement: Beginning with the [***] Year of Sale, the Minimum Royalty for OMP Territory for a given Year of Sale shall be the royalty due for the prior Year of Sale. [***] However, in the event, the effective royalties are higher than the

 

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

 

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Minimum Royalty for OMP Territory, the effective royalty shall apply. In no event shall Minimum Royalty for OMP Territory be payable for more than the first [***] Years of Sale even if the Product is sold in the OMP Territory in a different form or formulation or is a Combination Product.

 

(ii)                                   If OMP has not achieved the Minimum Royalty for OMP Territory due hereunder for a Year of Sale, OMP shall pay Grünenthal the difference between the Minimum Royalty for OMP Territory due and the royalties actually paid for that particular Year of Sale. Such difference shall be due and payable as an adjustment when the next OMP Territory Earned Royalty payment is due according to Section 6.12 .

 

(iii)                                In the event of the abatement or reduction of the OMP Territory Royalties in accordance with Sections 6.8, 6.9 and 6.11 , the Minimum Royalty for OMP Territory shall be adjusted proportionately.

 

(b)                                  [Reserved]

 

(c)                                   The Minimum Royalty for OMP Territory shall be abated during the calendar year and during any subsequent period in which any of the following conditions exist and are continuing to materially impact the marketing of the Product: The Product(s) have been withdrawn from the market by OMP

 

(i)                                      in response to a regulatory agency request, threat or order to withdraw or recall such product, or

 

(ii)                                   for reasons related to safety or product defects pertinent to safety, which in OMP’s view, subject to Grünenthal´s approval, which shall not be unreasonably withheld or delayed, warrant a voluntary recall of the Product.

 

(d)                                  No earlier than [***] following the occurrence of one or more of the following conditions, OMP may notify Grünenthal of such condition(s) and the Parties shall negotiate in good faith the size of any reduction (between 1 and 100%) of the Minimum Royalty for OMP Territory, for the calendar year and any

 

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

 

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subsequent period in which any of the following conditions exist and are continuing to materially impact the marketing of the Product;

 

(i)                                      sales are reduced as a result of material regulatory issues which arise in connection with the Product such as “Dear Doctor letters”, or

 

(ii)                                   sales are reduced as a result of material supply problems or lack of supply not caused by OMP or that are a result of a force majeure event.

 

(iii)                                sales are reduced as a result of a negative market impact based on a negative drug class effect on the class in which class the Product is contained, or

 

(iv)                               sales are reduced as a result of other external impacts, including, but not limited to, governmental price restrictions, parallel import of the Product, compulsory licenses for the Product, changes in managed care treatment protocols

 

4.5                               Promotion Compliance Responsibilities . In the OMP Territory, OMP, in Promoting a Product, and Grünenthal, to the extent Grünenthal participates in a scientific or educational event held in the OMP Territory shall in all material respects conform their practices and procedures relating to such Promotion to the FD&C Act, the PHS Act, the Pharmaceutical Research and Manufacturers of America (“ PhRMA ”) Code of Pharmaceutical Marketing Practices (the “ PhRMA Code ”) and the American Medical Association (“ AMA ”) Guidelines on Gifts to Physicians from Industry (the “ AMA Guidelines ”), as the same may be amended from time to time, and promptly notify the other Party of and provide a copy of any material correspondence or other reports with respect to Promotion of a Product submitted to or received from the FDA, PhRMA or the AMA relating to the FD&C Act, the PHS Act, the PhRMA Code, or the AMA Guidelines.

 

Each Party shall be fully responsible for disseminating accurate information regarding any Product to its professional sales representatives. The Parties

 

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

 

25



 

agree to use Commercially Reasonable and Diligent Efforts to exchange copies of their respective promotional materials in the OMP Territory and EU. To the extent a Party engages in communication over the Internet such communication shall clearly implement reasonable safeguards designed to prevent transmission to or access to target audiences in the other Party’s Territory.

 

4.6                              Distribution .

 

(a)                                  Customer Support . OMP shall use Commercially Reasonable and Diligent Efforts to perform all customer support services which require Regulatory Approval, acquiescence or oversight, including, without limitation, pharmacovigilance, responding to physician inquiries, or professional education.

 

(b)                                  Recalls . The Parties and their distributing entities shall use good faith and reasonable efforts to coordinate any decision making and communication with respect to issuing a recall, market withdrawal, suspension or correction of any Product, provided that, to the extent required by regulatory timeframes or public safety considerations, each Party shall have the right to make the product recall decision within its Territory. Each Party shall notify the other Party promptly (and in any event within [***] of receipt of written notice) if any Product is alleged or proven to be the subject of a recall, market withdrawal, suspension or correction in any country in its Territory. During the term of this Agreement, each Party shall be responsible for: handling and implementing all recalls and market withdrawals, suspensions or corrections of any Product in its Territory. The other Party will make available to the Party, upon request, all of the other Party’s pertinent records that the other Party may reasonably request to assist it in effecting any of the foregoing. A Party shall have no obligation to reimburse or otherwise compensate the other Party for any Losses (as defined in Section 13.1 ) that may arise in connection with any such recall, market withdrawal, suspension or correction relating to such other Party´s Territory, unless and to the extent such action is due to negligence or willful misconduct in the manufacturing distribution, Promotion and post marketing surveillance activities, of Product, by such Party. Any investigation conducted in connection with such an action shall be undertaken jointly by the Parties.

 

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

 

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4.7                               [Reserved]

 

4.8                               Contact to Supra National Agencies. Grünenthal shall have the sole right and responsibility to initiate and/or respond to all contacts with supra national agencies (i.e. WHO), other than Regulatory Authorities, worldwide relating to the Products, which are Commercialized. Grünenthal shall retain responsibility for communicating with all such agencies and satisfying all requirements regarding the Products. Each Party shall inform the other Party of the substance of all communication with all such agencies. OMP shall assist Grünenthal, if Grünenthal requests OMP to do so, and Grünenthal shall, if requested by OMP, consult with OMP in preparing such communications with the relevant supra national agency. Each Party shall be permitted to accompany the other Party to any meeting with such agency, take part in any such communications and receive copies of all such communications. Notwithstanding the foregoing, OMP may respond to any agency’s inquiry regarding the Products, in coordination with Grünenthal, if and only if:

 

(a)                                  in the reasonable opinion of OMP´s counsel, such response is necessary to comply with the requirements of any law, governmental order or regulation, and

 

(b)                                  OMP has requested the agency to direct the inquiry to Grünenthal instead of OMP, and such agency has refused such request; but in any such event, unless in the considered opinion of OMP’s counsel there is a legal prohibition against doing so, OMP shall immediately notify Grünenthal of such agency’s inquiry and of OMP’s intention to make such response.

 

ARTICLE 5                            TRADEMARK AND APPEARANCE

 

The Parties have selected and developed different trademarks for their respective Territory i.e. Nucynta ®  for the OMP Territory and Palexia ®  and Nucynta ®  for the Grünenthal Territory.  Each Party’s trademark will be owned by Grünenthal and upon Grünenthal’s request the trademark Nucynta ®  in the OMP Territory shall be assigned to Grünenthal as described below.  In the case of assignment of this Agreement by

 

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

 

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OMP to a Third Party, OMP shall simultaneously assign the trademark Nucynta ®  for the OMP Territory to such Third Party. Upon Grünenthal’s request, such Third Party shall assign such trademark to Grünenthal.  Each Party shall bear the respective costs for such development and maintenance of the trademark in its Territory. Grünenthal grants to OMP a royalty free, exclusive license to use the trademark selected by OMP for the OMP Territory for the Term of the Agreement and after expiration of the Term of Agreement solely in connection with Product and the Field.

 

ARTICLE 6                            PAYMENTS

 

In consideration of the assignments, rights and licenses granted under this Agreement, OMP agrees to pay (or has paid pursuant to the Combined Territories License Agreement) Grünenthal as follows:

 

6.1                               Considerations of OMP to Grünenthal .

 

(a)                                  Upfront Payments for OMP Territory .

 

(i)                                      OMP agreed to pay, and has paid, to Grünenthal a non-refundable upfront payment of $20,000,000.

 

(ii)                                   The obligation to make this payment, as well as any other payments under Section 6.2 , shall not once accrued or paid be affected by any termination under Article 15 . A holding of invalidity or unenforceability of any Grünenthal Patent for which no further appeal is or can be taken shall not affect any obligation already accrued hereunder but shall only affect those payments otherwise due under such Grünenthal Patent from the date such holding becomes final.

 

(b)                                  Milestone Payments in connection with the OMP Territory .

 

(i)                                      OMP agreed to make, and made, the following non-refundable payments to Grünenthal upon the first occurrence of each milestone event with respect to the Product, during the term of the Combined Territories License Agreement.

 

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

 

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Events

 

Payment

Within [***] of the enrollment of the fifth patient in the first Phase III Clinical Trial

 

[***]

Within [***] of the first NDA filing in the United States and acceptance for review by the FDA of a NDA

 

[***]

Within [***] of the Regulatory Approval in the United States of the first of the Products

 

[***]

 

(ii)                                   It is understood that in no event should OMP be obligated to make the payment due on any milestone more than once with respect to the Product, regardless of the number of indications in the Field for which such Product is developed or regardless of the number of different forms or formulations which are developed. In no event shall OMP be obligated to make aggregate milestone payments in the OMP Territory which exceed $25,000,000 for the Products in the Field.

 

No additional royalties, milestones or up front payments shall be due Grünenthal for any modifications to, including addition of, RAP Plans.

 

(c)                                   Payments in connection with RAP Plan 1.63.1 and OMP Territory Earned Royalty Payments .  OMP agreed to pay, and paid, to Grünenthal for the extension of the license for Regulatory Approval Preparation as per Section 2.1(c)  and for the provision of all data and documents pertaining to Study KF5503/21 and its use in OMP Territory, a lump sum of twelve million US Dollars ($12,000,000).  Such lump sum was agreed upon between the Parties based on the estimated costs for the Study KF5503/21 plus a surcharge of fifty percent (50%) of such estimated costs.

 

(d)                                  [Reserved]

 

(e)                                   [Reserved]

 

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

 

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(f)                                    Proportionate Share . In consideration of the share of the market potential of either Party´s Territory, of the extension of this Agreement through the amendments to this Agreement and further in consideration of Grünenthal’s preparation of Study KF 5503/21, all RAP Costs and FTE resources including, without limitation, all preclinical, clinical costs and FTE resources shall be shared between OMP and Grünenthal as follows (each Party’s share being its “ Proportionate Share ”):

 

(i)                                      with regard to Products developed in accordance with the RAP Plan 1.63, so that [***] and

 

(ii)                                   with regard to Products developed in accordance with RAP Plan 1.63.1 so that [***].

 

6.2                               Payment of RAP Costs .

 

With regard to OMP Territory and Gr ü nenthal Territory . Resource plans will be developed initially and updated on a regular basis with approval from the Parties. OOPs will be managed by a common account (“ OOP Account ”), starting on January 1, 2003. The Parties will make reasonable efforts to share the FTE resources according to their Proportionate Share as long as reasonable for the project (time to market, expertise, costs, etc.). The deviation between the Proportionate Share split will be determined and balanced by a common escrow account (“ FTE Account ”) every [***] starting on January 1, 2003. The Exceeding FTEs will be charged at the then existing OMP FTE rate(s) as specified in the RAP Plan. As used herein, “ Exceeding FTEs ” mean the disproportionate amount of FTEs used by one Party compared to the other Party. FTE funds will accrue interest on an annualized basis as calculated using British Bankers Association 12 months Euro LIBOR as fixed two banking days prior to the date on which a Proportionate Share split is determined and balanced. The FTE Account will be carried forward until the end of the Core RAP Program. Each Party will have the opportunity, by providing extra FTEs in order to reduce Exceeding FTEs (provided such are approved in the RAP Plan), to recover parts of its payment into the FTE

 

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

 

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Account as long as the threshold of [***] is not exceeded. If the rolling balance in favor of one Party exceeds the threshold of [***] the exceeding amount should be paid to the Party who has provided the Exceeding FTEs. The amount in the FTE Account at the end of the Core RAP Program should be paid to the Party who provided the Exceeding FTEs.

 

(i)                                      Cost Overruns . If actual RAP expenses exceed the RAP Costs and FTE resources approved by the Parties and allocated to one Party (“ Cost Overruns ”) in accordance with this Section 6.2 , these Cost Overruns shall be shared by the Parties according to its Proportionate Share up to an amount of [***] of the amount approved by the Parties. Additional expenses and FTE resources over and above the [***] limit shall be solely borne by the Party for the activity that resulted in such overage; provided, however, that if such Party is able to demonstrate to the reasonable satisfaction of the other Party that such overage is in the interest of both Parties, such overage shall be shared by the Parties according to its Proportionate Share.

 

The share of Cost Overruns does not apply to RAP expenses allocated to one Party by 100%.

 

(ii)                                   Records and Audits . During the term of this Agreement, each Party shall keep and maintain accurate and complete records showing the expenses incurred by it in performing its activities under the RAP Plan during the three (3) preceding calendar years, which books and records shall be in sufficient detail such that RAP Costs can accurately be determined. Upon [***] prior written notice from a Party (the “ Auditing Party ”), the other Party (the “ Audited Party ”) shall permit an independent certified public accounting firm of internationally recognized standing and designated by the Parties at its first meeting, to examine the relevant books and records of the Audited Party and its Affiliates as may be reasonably necessary to verify the reports submitted by the Audited Party and the accuracy of any reconciliation report. An examination by a Party under this Section 6.2 shall occur not

 

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

 

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more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than [***] before the date of the request. Once materials or accounts have been audited, no subsequent audit on them may be performed. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both OMP and Grünenthal a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Auditing Party. If the accountant determines that errors were made in the reports so submitted, the Parties shall promptly correct any errors and make any necessary adjustments. The Auditing Party shall bear all costs and expenses of the audit, provided, however, that if the audit reveals that the Audited Party has incorrectly charged to the OOP Account the lesser of [***] more than entitled to or an amount exceeding [***] more than entitled to, the Audited Party shall bear all costs and expenses of the audit.

 

6.3                               Earned Royalties For Products in OMP Territory . For the OMP Territory, OMP shall pay Grünenthal a royalty for the rights granted based on cumulative moving annual total Net Sales of Products (other than Combination Product) sold by or for OMP, or its Affiliates according to the following schedule:

 

(a)                                  [***] within the first [***] after First Commercial Sale in OMP Territory;

 

(b)                                  [***] within the months [***] after First Commercial Sale in OMP Territory if moving annual total Net Sales in OMP Territory do not exceed [***], otherwise,

 

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

 

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the royalty rate in 6.3(d) or 6.3(e) will apply depending on the moving annual total Net Sales in OMP Territory;

 

(c)                                   [***] starting at the [***] after First Commercial Sale in OMP Territory provided that moving annual total Net Sales in OMP Territory are below [***];

 

(d)                                  [***] if moving annual total Net Sales in OMP Territory are greater than or equal to [***] but do not exceed [***];

 

(e)                                   [***] if moving annual total Net Sales in OMP Territory are equal to or greater than [***]

 

6.4                               Royalties For Combination Products in OMP Territory .

 

(a)                                 In case of a Combination Product sold by or for OMP, or its Affiliates hereunder in the OMP Territory, the royalties to Grünenthal shall be paid according to the following schedule, collectively with the payments set forth in Section 6.3 , the “ OMP Territory Earned Royalties ”:

 

(i)                                      [***] starting at the First Commercial Sale in OMP Territory provided that moving annual total Net Sales in OMP Territory are below [***];

 

(ii)                                   [***] if moving annual total Net Sales in OMP Territory are greater than or equal to [***] but do not exceed [***];

 

(iii)                                [***] if moving annual total Net Sales in OMP Territory are equal to or greater than [***].

 

In the event that OMP has solely developed a Combination Product the applicable royalty shall be reduced by [***] of Net Sales.

 

(b)                                  [Reserved]

 

(c)                                   Royalties For Combination Products For OMP . In the event that OMP has solely developed a Combination Product, Grünenthal shall pay OMP a royalty based on total Net Sales of such Combination Products sold by or for Grünenthal, or its Affiliates in the Grünenthal Territory of [***].

 

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

 

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6.5                               Royalty Calculation Method . Once the royalty range threshold for the OMP Territory is exceeded (according to Sections 6.3 or 6.4 ) the increased OMP Territory Earned Royalty is due on total Net Sales.

 

In [***] of each year, the cumulative sales of the prior [***] period ( [***]) in the OMP Territory shall be compared to the royalty ranges as described above in Sections 6.3 or 6.4 , to set the applicable OMP Territory Earned Royalty rate for the cumulative sales of the prior [***] period ( [***]) in the OMP Territory. An example of the OMP Territory Earned Royalty calculation is attached hereto as Exhibit  6.5 .

 

6.6                               [Reserved]

 

6.7                               [Reserved]

 

6.8                               Royalty Rate Reduction .

 

(a)                                  Third Party Patents. In the event OMP pays for the OMP Territory a royalty to a Third Party which is other than an Affiliate, pursuant to Section 7.11 of this Agreement, then for the OMP Territory, as applicable, OMP shall be entitled to a credit against the applicable r oyalty payments due to Grünenthal under this Agreement of an amount equal to [***] of the royalty actually paid to any such Third Party which is other than an Affiliate, with the credit not to exceed [***] of the applicable royalty rate due to Grünenthal under this Agreement. Additional royalties paid to Third Parties shall not be considered for COGS cap calculations according to Section 6.9 .

 

(b)                                  Compulsory License. If at any time and from time to time a Third Party in any country in the OMP Territory shall, under the right of a compulsory license granted or ordered to be granted by a competent governmental authority, manufacture, use or sell any Product, with respect to which Earned Royalties would be payable pursuant to this Agreement, then OMP shall inform Grünenthal thereof and both Parties shall negotiate in good faith the size of an equitable reduction of the applicable royalty. In principle, the reduction shall be calculated after consideration of the territory concerned, the owner of the

 

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

 

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compulsory license and its marketing and distribution capability, pricing and other market conditions at the time of granting such compulsory license, the royalty rate of the compulsory license, the life cycle phase of the Product and an equitable distribution of the financial consequences for the Parties.

 

(c)                                   Competition in OMP Territory .

 

(i)                                      If, at any time, after a composition of matter Patent claiming CG-5503 is no longer in force and prior to expiration of the last Grünenthal Patent claiming the Product (other than Combination Product), or OMP Patent claiming the Product, OMP loses Market Exclusivity in the OMP Territory, the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.3 on all Products in the OMP Territory shall be [***]. Thereafter, if as a result of OMP´s loss of Market Exclusivity in the OMP Territory, OMP´s aggregate share of all products containing CG-5503 (excluding Combination Product) as shown in IMS in such country is less than [***], then the amount of OMP Territory Earned Royalties payable to Grünenthal for all Products according to Section 6.3 shall be [***]; when the share is less than [***]; the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.3 shall be [***], and when the share is less than [***], the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.3 shall be reduced by [***]. Thereafter, even if there is a further loss of OMP´s share of all products containing CG-5503 in the OMP Territory, the royalty rate reduction shall [***].

 

(ii)                                   If, at any time , after a composition of matter Patent claiming CG-5503 is no longer in force and prior to expiration of the last Grünenthal Patent claiming that particular Combination Product, or OMP Patent claiming that particular Combination Product, OMP loses Combination Product Market Exclusivity in the OMP Territory, the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 

 

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

 

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6.4 on such Combination Product in the OMP Territory shall be [***]. Thereafter, if as a result of OMP´s loss of Combination Product Market Exclusivity in the OMP Territory, OMP´s aggregate share of all combination products as shown in IMS containing CG-5503 and the same active pharmaceutical ingredient(s) in such country is less than [***], then the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.4 for such Combination Product shall be [***]; when the share is less than [***], the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.4 shall be [***], and when the share is less than [***], the amount of OMP Territory Earned Royalties payable to Grünenthal according to Section 6.4 shall be [***]. Thereafter, even if there is a further loss of OMP´s share of all combination products containing CG-5503 and the same active pharmaceutical ingredient(s), the royalty rate reduction shall [***]. This mechanism for royalty rate reduction shall be used separately for each particular Combination Product.

 

(d)                                  [Reserved]

 

(e)                                   Royalties on Know-How of a Product containing CG-5503 as the sole active pharmaceutical ingredient. On a country-by-country basis, until the last to expire Grünenthal Patent, or OMP Patent claiming the formulation of the Product, under which Earned Royalties are being paid (the “ Last Patent ”), a royalty for Grünenthal Know-How is included in the Earned Royalty rates. After the Last Patent expires, the applicable royalty payable for the period recited in Section 6.11(a)  shall be [***].

 

(f)                                    Royalties on Know-How of Combination Products . On a country-by-county basis, until the last to expire Grünenthal Patent, or OMP Patent claiming the formulation of a particular Combination Product, under which royalties are being paid (the “ Last Combo Patent ”), a royalty for Grünenthal Know-How is included in the Earned Royalty rates. After the Last Combo Patent expires,

 

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

 

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the applicable royalty payable by OMP for the period recited in Section 6.11(b)  shall be [***].

 

(g)                                   Royalty Rock Bottom .

 

(i)                                      The total OMP Territory Earned Royalty rate reductions under Sections 6.8(a) through 6.8(f)  cannot exceed [***] in the applicable OMP Territory Earned royalty based on the level of moving annual Net Sales in Section 6.3 . Notwithstanding the foregoing, the effective OMP Territory Earned Royalty rate shall in no case be below [***] of Net Sales.

 

(ii)                                   [Reserved]

 

6.9                               Cost of Goods Sold Cap (“ COGS Cap ”) in OMP Territory . Cost of Goods Sold in OMP Territory should not exceed [***]. The applicable OMP Territory Earned Royalty rate under consideration of this COGS Cap, shall be calculated in accordance with the timelines mentioned in Section 6.5 . In the event the total COGS percentage exceeds the [***] threshold, the incremental percentage over the [***] threshold will be reduced from the OMP Territory Earned Royalty rate so that the reduction in royalties will result in a total COGS equal to [***]. In any instance where a royalty reduction is in effect (e.g., under Section 6.8 ) the royalty reduction will also apply to the COGS Cap, such that the COGS Cap is also reduced. For the purposes of Fully Allocated Manufacturing Costs/royalty calculation, the average of the OMP and Grünenthal Fully Allocated Manufacturing Costs, without any internal mark-ups of Affiliates and/or external royalties to licensors of OMP-ADF-Formulation, shall be used. In order to determine the average, each Party shall provide to the other Party its Fully Allocated Manufacturing Costs on an annual basis which shall be subject to audit by the other Party in accordance with Section 6.12(f) . The rights to audit (with Grünenthal personnel or outside auditors) the records of OMP and its Affiliates as provided for under this Agreement shall extend to audits of OMP’s and its Affiliates’ records for purposes of confirming the Cost of Goods contemplated by this Section.

 

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

 

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6.10                        Minimum Royalties . Minimum Royalty for OMP Territory shall be paid as stipulated in Section 4.4 .

 

6.11                        Term For Royalty Payment .

 

(a)                                  Earned Royalties for the licenses granted and the Grünenthal Know-How provided, payable for any Product containing CG-5503 as sole active pharmaceutical ingredient being sold, shall be paid on a country-by-country basis from the date of First Commercial Sale of such Product until the last to expire of any Grünenthal Patent or OMP Patent licensed hereunder containing a Valid Patent Claim claiming the formulation for such Product (the “ Last Patented Product ”). Earned Royalties solely for Grünenthal Know-How payable under Section 6.8(e)  for the Last Patented Product being sold shall be paid on a country-by-country basis from the date of expiration of the last to expire of any such Grünenthal Patent or OMP Patent licensed hereunder containing a Valid Patent Claim claiming the Last Patented Product until the generic equivalent (as defined by the then current FDA regulations) enters the market (“ Generic Market Event ”), at which time the applicable OMP Territory Earned Royalty solely for Grünenthal Know-How payable under Section 6.8(e)  shall cease.

 

(b)                                  Earned Royalties payable for the licenses granted and the Grünenthal Know-How provided for each Combination Product being sold shall be paid on a country-by-country basis from the date of the First Commercial Sale of each such Combination Product until the last to expire of any Grünenthal Patent or OMP Patent licensed hereunder containing a Valid Patent Claim claiming the formulation of the Combination Product (the “ Last Combo Product ”). Earned Royalties solely for Grünenthal Know-How payable for the particular Combination Product being sold on a country-by-country basis from the date of expiration of the last to expire of any such Grünenthal or OMP Patent licensed hereunder containing the particular Combination Product until an applicable Generic Market Event, at which time the applicable OMP Territory

 

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

 

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Earned Royalty solely for Grünenthal Know-How payable under Section 6.8(f)  shall cease.

 

6.12                        Royalty Reports and Records . The following Sections 6.12(a) and (b)  shall apply for the OMP Territory.

 

(a)                                  During the term of this Agreement and commencing with the First Commercial Sale of Product, OMP shall furnish, or cause to be furnished to Grünenthal, written reports, including the applicable royalty payment due, within sixty (60) days following the end of each [***] for which royalties are due, showing:

 

(i)                                      the detailed calculation of monthly Net Sales of all Products sold by OMP and its Affiliates during the calendar half-year;

 

(ii)                                   the detailed calculation of Earned Royalties, payable in U.S. Dollars, which shall have accrued hereunder in respect to such Net Sales;

 

(iii)                                the exchange rates used, if any, in determining the amount of Dollars; and

 

(iv)                               any withholding taxes required to be paid from such Earned Royalties.

 

(b)                                  All Earned Royalties payments to be made by OMP to Grünenthal shall be made in U.S. Dollars within [***] following the end of [***] for which such Earned Royalties are due, to a Grünenthal bank account.

 

(c)                                   [Reserved]

 

(d)                                  To the extent it is necessary to convert currencies for OOPs development costs incurred pursuant to the RAP plan, such reconciliation shall be made in Euros using the applicable arithmetic average exchange rate for converting the applicable currency to the Euro as published by the European Central Bank on the last business day of each month during the period (quarter).

 

(e)                                   OMP shall keep accurate records in sufficient detail to enable Earned Royalties and other payments payable hereunder to be determined. OMP

 

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

 

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shall be responsible for all Earned Royalties and late payments that are due to Grünenthal that have not been paid by OMP and its Affiliates. Late payments shall accrue interest on an annual basis at a rate of [***].

 

(f)                                    OMP and its Affiliates shall maintain complete and accurate records, in accordance with United States generally accepted accounting principles, which are relevant to costs, expenses and payments under this Agreement and such records shall be open during reasonable business hours for a period of three (3) years from creation of individual records for examination at Grünenthal’s expense and not more often than once each year by a certified public accountant or other representative selected by Grünenthal and acceptable to OMP for the sole purpose of verifying the correctness of calculations or such costs, expenses or payments made under this Agreement. In the absence of material discrepancies (in excess of [***]) in any request for reimbursement resulting from such audit, the accounting expense shall be paid by Grünenthal. If material discrepancies do result, OMP shall bear the reasonable audit expense. Any records or accounting information received from OMP shall be Confidential Information for purposes of Article 8 .

 

6.13                        Taxes .

 

(a)                                  OMP will make all payments to Grünenthal under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by law in effect at the time of payment.

 

(b)                                  Any tax required to be withheld on amounts payable under this Agreement will promptly be paid by OMP on behalf of Grünenthal to the appropriate Governmental Authority, and OMP will furnish Grünenthal with proof of payment of such tax. Any such tax required to be withheld will be an expense of and borne by Grünenthal.

 

(c)                                  OMP and Grünenthal will cooperate with respect to all documentation required by any taxing authority or reasonably requested by OMP to secure an exemption or reduction in the rate of applicable withholding taxes.

 

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

 

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(d)                                  If OMP had a duty to withhold taxes in connection with any payment it made to Grünenthal under this Agreement but OMP failed to withhold, and such taxes were assessed against and paid by OMP, then Grünenthal will indemnify and hold harmless OMP from and against such taxes (including interest). If OMP makes a claim under this Section 6.13(d) , it will comply with the obligations imposed by Section 6.13(b) , as if OMP had withheld taxes from a payment to Grünenthal.

 

(e)                                   OMP shall, in consultation with Grünenthal, take all legally available and reasonable steps to mitigate any circumstances in OMP’s control which arise and which would result in any amount becoming subject to deduction or withholding of taxes pursuant to subclause (a) of this clause, unless Grünenthal would reasonably be expected to be entitled to a credit or refund for such deduction or withholding at any time.

 

6.14                        Grünenthal As Licensee. The provisions of Sections 6.5, 6.8(a) through 6.8(e), 6.10, 6.11 through 6.13, and 6.16 shall apply with equal force to Grünenthal in the event that Grünenthal is the licensee of any Combination Product.

 

6.15                        Remittance .

 

(a)                                  Payments from OMP to Grünenthal required to be denominated in USD shall be made to Grünenthal as beneficiary to [***] or another bank account as provided by Grünenthal.

 

(b)                                  Payments from OMP to Grünenthal required to be denominated in EUR shall be made to Grünenthal as beneficiary to [***] or another bank account as provided by Grünenthal.

 

(c)                                   [Reserved]

 

6.16                        No Overlapping Royalties. Notwithstanding any other provision of this Agreement, in no event shall any Earned Royalty provided for under any Section of this Agreement be paid with respect to any sale of a specific Product to the extent a payment has been paid pursuant to any other Section 

 

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

 

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of this Agreement with respect to such sale of the same specific Product provided that the higher payment amount is paid.

 

6.17                        Payments to or Reports by Affiliates .  Any payment required under any provision of this Agreement to be made to either Party or any report required to be made by either Party shall be made to or by an Affiliate of such Party if designated as the appropriate recipient or reporting entity.

 

ARTICLE 7                            IMPROVEMENTS/OWNERSHIP OF INTELLECTUAL PROPERTY

 

7.1                               Ownership of Intellectual Property and Patent Rights on Combined Territories License Agreement Effective Date .  Unless otherwise stipulated in this Agreement the intellectual property position of the Parties remains unchanged under this Agreement.

 

7.2                               Maintenance of Grünenthal Background Patents . Grünenthal agrees to prosecute, maintain and extend - where possible - all Grünenthal Background Patents. This does not apply to Grünenthal-ADF-Formulation Patents unless it is mutually agreed under Section 12.1(b)  to develop the Grünenthal-ADF-Formulation.

 

7.3                               Disclosure of Improvements . Each Party shall disclose to the other Party any Improvement as soon as reasonably possible after creation. Any information on the OMP-ADF-Formulation or Grünenthal-ADF-Formulation shall only be shared under a separate, mutual secrecy agreement as provided for by Section 12.1(b) .

 

7.4                               Ownership of Improvement Patents and Improvements . Inventorship for Improvements which are inventions, shall be determined in accordance with U.S. patent laws for determining inventorship and ownership of Improvement Patents and Improvements shall be determined based on inventorship. Notwithstanding the foregoing, in the event of Improvements conceived and/or reduced to practice by employees, agents, officers, contractors or Affiliates of both Parties ownership of any such Improvements and resulting Improvement

 

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

 

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Patents shall be assigned solely to Grünenthal. In connection with Improvements which do not result in Improvement Patents or a Trade Secret and where an employee, agent, officer, contractor or Affiliate of OMP contributed, both Parties shall have an unrestricted right to use such Improvement for any purpose. During the Term of this Agreement, Grünenthal shall, at its sole expense, file, prosecute, maintain and defend Improvement Patents which are owned by Grünenthal. OMP agrees to cause its employees, agents, officers, contractors or Affiliates to cooperate fully with Grünenthal in the preparation, filing and prosecution of any Improvement Patent wherein an employee, agent, officer, contractor or Affiliate of OMP contributed, and, with respect to such Improvement Patent, to execute any necessary assignments to Grünenthal. During the Term of this Agreement OMP shall at its own expense file, prosecute, maintain and defend all Improvement Patents which are owned by OMP.

 

7.5                               Filing of Improvement Patents . All Improvement Patents will be filed at least in the U.S. and European Patent Office. Each Party shall give prior written notice to the other Party of the countries in which it intends to file, including conflict proceedings, re-examinations, reissuance, oppositions and revocation proceedings and abandonment and the other Party shall have the right at that Party’s expense to continue prosecution in countries for which the other Party intends to abandon. The Parties agree to use reasonable efforts to ensure that any Improvement Patent filed outside of the United States prior to a U.S. filing will be in a form sufficient to establish the date of original filing as a priority date for the purposes of a subsequent U.S. Filing.

 

7.6                               Extensions . Each Party shall file and prosecute to obtain extensions of its respective OMP Patent or Grünenthal Patent in the Field in any countries in which such extensions are available. Each Party shall provide such assistance as may reasonably be required for the other Party to fulfil its foregoing obligations.

 

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

 

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7.7                      Ownership of ADF-Formulation Patents and ADF-Formulation Improvements .

 

(a)                                  Inventorship for ADF-Formulation Patents shall be determined in accordance with U.S. patent laws for determining inventorship. OMP-ADF-Formulation Improvements and/or inventions relating to OMP-ADF-Formulations shall be solely owned by OMP, regardless of inventorship. During the Term of this Agreement, OMP shall, at its sole expense, file, prosecute, maintain and defend OMP ADF-Formulation Patents. Grünenthal agrees to cause its employees, agents, officers, contractors or Affiliates to cooperate fully with OMP in the preparation, filing and prosecution of any OMP ADF-Formulation Patent wherein an employee, agent, officer, contractor or Affiliate of Grünenthal or contractor of Grünenthal’s Affiliate contributed as an inventor, and, with respect to such OMP ADF-Formulation Patent, to execute any necessary assignments to OMP. OMP shall comply with the duties under German laws regarding invention by employees (Arbeitnehmererfinderrecht) with regard to the rights of any employee, agent, officer, contractor of Grünenthal or its Affiliates.

 

Grünenthal ADF-Formulations Improvements and/or inventions relating to Grünenthal ADF-Formulations shall be solely owned by Grünenthal, regardless of inventorship. During the Term of this Agreement, Grünenthal shall, at its sole expense, file, prosecute, maintain and defend Grünenthal ADF-Formulation Patents. OMP agrees to cause its employees, agents, officers, contractors or Affiliates to cooperate fully with Grünenthal in the preparation, filing and prosecution of any Grünenthal ADF-Formulation Patent wherein an employee, agent, officer, contractor or Affiliate of OMP or contractor of OMP’s Affiliate contributed as an inventor, and, with respect to such Grünenthal ADF-Formulation Patent, to execute any necessary assignments to Grünenthal.

 

(b)                                  Inventorship for Independent ADF Formulation Improvements which are inventions, shall be determined in accordance with U.S. patent laws for determining inventorship and Independent ADF Formulation Improvement Patents and Independent ADF Formulation Improvements shall be owned by the Party that has introduced such Independent ADF Formulation

 

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

 

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Improvements Patents and Independent ADF Formulation Improvements into the joint development of an ADF Formulation for the Product under this Agreement. During the Term of this Agreement, Grünenthal shall, at its sole expense, file, prosecute, maintain and defend Independent ADF Formulation Improvement Patents which are owned by Grünenthal. During the Term of this Agreement OMP shall at its own expense file, prosecute, maintain and defend all Independent ADF Formulation Improvement Patents which are owned by OMP.

 

7.8                               Notice . The Parties shall promptly inform each other of any information that comes to their attention involving actual or apparent infringements or misappropriations by any Third Party of any Patent, Know-How or trademark licensed in this Agreement. The Parties shall also promptly inform each other of any claims of alleged infringement made by any Third Party against either Party or its respective Affiliates or sublicensees resulting from the manufacture, import, offer for sale, sale or use of the Product.

 

7.9           Infringement Claims Against Third Parties . If any Grünenthal Patent is infringed by a Third Party which is other than an Affiliate in any country in connection with the manufacture, use and sale of a Product in such country, Grünenthal shall have the primary right, but not the obligation to institute, prosecute, and control any action or proceeding with respect to such infringement of any such Grünenthal Patent by counsel of its own choice and at its own expense, with OMP having the primary right in connection with OMP Patents at OMP´s own expense. If the Party having the primary right fails to bring an action or proceeding or otherwise accomplishes to stop the infringement within one hundred eighty (180) days after a request by the other Party to do so, the other Party shall have the right to bring and control any suit for infringement under this Section, and the Party bringing any such suit shall bear all costs and expenses of the suit and shall retain any damages or other monetary awards recovered. The Party bringing suit under this Section 7.9 shall keep the other Party reasonably informed as to the progress of the suit and all settlement discussions.  A settlement or consent judgment or other voluntary final disposition of a suit brought by a Party under this Section may not be entered into without the prior written consent of the Party owning the Patent which is the subject matter of the suit (which consent shall not be unreasonably withheld or delayed); provided that such settlement, consent judgment or other disposition does not admit the invalidity or unenforceability of any Patent; and provided further, that any rights to continue the infringing activity in such settlement, consent judgment or other disposition shall be limited to the product or activity that was the subject of the suit.

 

7.10         Assistance . In the event of any patent infringement litigation involving the Product and any Patent, the non-prosecuting or non-defending Party shall render such reasonable assistance as may be requested by the prosecuting or defending Party in connection with such infringement actions. If one Party requests the other Party’s reasonable assistance in connection with such infringement claims or actions, the requesting Party shall reimburse the other Party for such direct, documented out-of-pocket expenses as are reasonably incurred during the course of its providing such requested assistance. Before incurring such expenses, the Parties shall in good faith agree in writing on the nature and extent of assistance to be rendered.

 

7.11         Third Party Patents . If a Patent or Patents of a Third Party should exist or should issue to a Third Party in any country in the OMP Territory during the term of this Agreement, which OMP believes, in its reasonable judgment, may be infringed by the manufacture, use or sale of the Product in such country, and OMP believes in its reasonable judgment, that it would be impractical or impossible to continue to Commercialize or Commercialize the Product without obtaining a royalty bearing license from such Third Party under such Patent or Patents in said country, then OMP shall promptly notify Grünenthal in writing to that effect with legal opinions. OMP and Grünenthal shall [***] towards the Patent of such Third Party under the consideration of the interest of both Parties. However, if the Parties are unable to agree on [***], the dispute will be referred to the responsible managing director of Grünenthal and the President of OMP for resolution. If these individuals cannot agree [***] shall have the right to participate in all negotiations with such Third Party directed to obtain rights to such Patent of the Third Party. [***] shall comply with any [***] in the case where the Parties have reached [***]. In case a license has been obtained from a Third Party OMP may deduct from the amount of royalties due to Grünenthal on Net Sales of Product according to Sections 6.3 and 6.4(a) , as applicable, fifty percent (50%) of the Earned Royalty actually paid by OMP to any Third Party according to Section 6.8(a) , pursuant to a license entered into under this Section. This Section shall apply vice versa for Grünenthal if Grünenthal is making payments to OMP according to Section 6.4(c) . For the purpose of this Section 7.11 , Third Party shall exclude Affiliates.

 

[***]

 

7.12         Notices Relating to the Act . Grünenthal shall notify OMP of:

 

(a)                                  the issuance of each U.S. patent included among the Grünenthal Patents including — if the Parties have mutually agreed under Section 12.1(b)  to develop the Grünenthal-ADF-Formulation — the Grünenthal-ADF-Formulation Patents, giving the date of issue and patent number for each such Patent; and

 

(b)                                  communications pertaining to any patent included among the Grünenthal Patents including — if the Parties have mutually agreed under Section 12.1(b)  to develop the Grünenthal-ADF-Formulation — the Grünenthal-ADF-Formulation Patents which Grünenthal receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984

 

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

 

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(hereinafter the “ Act ), including but not necessarily limited to notices pursuant to §§101 and 103 of the Act from persons who have filed an abbreviated NDA ( ANDA ) or a “paper” NDA.

 

7.13                        Authorization Relating to Patent Term Extension . Grünenthal hereby authorizes OMP to

 

(a)                                  provide in any NDA a list of patents which includes Grünenthal Patents that relate to such Product and such other information as OMP believes is appropriate;

 

(b)                                  commence suit for infringement of Grünenthal Patents under § 271(e) (2) of Title 35 of the United States Code or any other relevant statute in any OMP Territory; and

 

(c)                                   exercise any rights that may be exercisable by Grünenthal as patent owner under the Act or any other relevant statute in any OMP Territory, including without limitation, applying for an extension of the term of any Patent included in Grünenthal Patents.

 

In the event that applicable law in any country provides for the extension of the term of any patent included among Improvement Patents or Grünenthal Patents, such as under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, the Supplementary Certificate of Protection of the Member States of the European Union and other similar measures in any other country, the Party owning such Grünenthal Patent or OMP Patent shall, at the other Party’s cost for its own Territory, apply for and use its reasonable efforts to obtain such an extension or, should the law require the other Party to so apply, the Party owning the Patent hereby gives permission to such other Party to do so. OMP and Grünenthal agree to cooperate with one another in obtaining such extension. Each Party agrees to cooperate with the other Party in the exercise of the authorization granted herein and will execute such documents and take such additional action as the may reasonably be necessary in connection therewith, including, if necessary, permitting itself to be joined as a Party in any suit for infringement brought by a Party hereunder.

 

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

 

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7.14                        Trade Secrets . Upon disclosure by one party of an Improvement to the other Party, the Parties will discuss whether it is appropriate to keep such Improvement as a Trade Secret. In the event the Parties agree to treat such Improvement as a Trade Secret, the Party/Parties who made the Improvement will take the necessary legal or organizational measures to protect such Improvement’s secrecy. Should one of the Parties disagree to keep such Improvement as a Trade Secret or no mutually decision be reached within 3 months from disclosure of the Improvement by one Party to the other Party such Improvement shall be filed as a Patent according to Section 7.5 unless otherwise agreed to.

 

ARTICLE 8                            CONFIDENTIALITY

 

8.1                               Confidentiality Exceptions . Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Information and other confidential and proprietary information and materials furnished to it by the other Party or developed by either Party pursuant to this Agreement (collectively, “ Confidential Information ”), except to the extent that it can be reasonably demonstrated by the receiving Party that such Confidential Information:

 

(a)                                  was in the lawful knowledge and possession of the receiving Party prior to the time it was disclosed to, or learned by, the receiving Party, or was otherwise developed independently by the receiving Party, as evidenced by written records kept in the ordinary course of business, or other documentary proof of actual use by the receiving Party;

 

(b)                                  was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

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

 

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(c)                                   became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; or

 

(d)                                  was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party which is other than an Affiliate who had no obligation to the disclosing Party not to disclose such information to others.

 

8.2                               Authorized Disclosure . Except as expressly provided otherwise in this Agreement, each Party may disclose Confidential Information of the other Party as follows:

 

(a)                                  to Third Parties under appropriate terms and conditions including confidentiality provisions substantially equivalent to those in this Agreement for consulting, manufacturing, development, external testing and marketing trials with respect to the Products covered by this Agreement, or otherwise as is reasonably necessary to exercise the rights and licenses granted herein (including the right to grant sublicenses according to this Agreement) or

 

(b)                                  to the extent such disclosure is reasonably necessary in filing or prosecuting patent, copyright and trademark applications, prosecuting or defending litigation, complying with applicable governmental regulations, obtaining Regulatory Approval, conducting preclinical or clinical trials, provided, however, that if a Party is required by law or regulation to make any such disclosure of the other Party’s Confidential Information it will (i), except where impracticable for necessary disclosures, for example in the event of medical emergency, give reasonable advance notice to the other Party of such disclosure requirement, (ii) except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed and (iii) only disclose such Confidentiality Information which in the opinion of the disclosing Party’s legal counsel is legally required to be disclosed after taking into due consideration the other Party’s opinion provided such opinion can be obtained in a timely manner.

 

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

 

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(c)                                   for Confidential Information other than Trade Secrets and information relating to Improvements and inventions, to those natural persons being ultimate beneficial owners of Grünenthal and the supervisory board and advisory board to the extent such disclosure is reasonably necessary or required by law and only to the extent such persons have a right under applicable German law or a need to know and unless already under confidentiality obligation by applicable German law, or under appropriate terms and conditions including confidentiality provisions substantially equivalent to those in this Agreement.

 

8.3                               Survival . This Article 8 shall survive the termination of this Agreement for a period of [***].

 

8.4                               Publications . Notwithstanding any other provision of this Agreement, neither Party shall be free to disclose the results of its activities conducted under this Agreement until [***] without the prior written consent of the other Party (which consent shall not be unreasonably withheld or delayed). The publishing Party shall submit any such proposed publication to the other Party at least [***] in advance to allow review of such planned public disclosure. The reviewing Party shall, within [***] days of receiving such proposed publication, inform the publishing Party in writing whether it denies its consent and on what basis. In all other cases the consent shall be deemed given. Notwithstanding the foregoing, the Parties will make reasonable efforts to exchange information relating to and discuss publication strategies relating to Products.

 

8.5                               Public Announcements . Neither Party shall originate any publicity, news release or public announcements, written or oral, whether to the public or press, stockholders or otherwise relating to this Agreement, including their existence, the subject matter to which the agreements relate, performance under the agreements or any of their terms, to any amendment hereto or thereto or performances hereunder or thereunder without the prior written consent of the other Party, save only such announcements that are required by law to be made or that are otherwise agreed by the Parties. Such announcements shall be brief and factual. If a Party decides to make an

 

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

 

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announcement required by law, it shall disclose such information only to the extent necessary according to local law and seek to avoid to the maximum possible any disclosure with regard to the financial conditions, chemical structures and names, including INN and substance-code-number. Such party will give the other Party at least [***] advance notice, where possible, of the text of the announcement so that the other Party will have an opportunity to comment upon the announcement. To the extent that the receiving Party reasonably requests that any information in the materials proposed to be disclosed or deleted, the disclosing Party shall request confidential treatment of such information pursuant to Rule 406 of the Securities Act of 1933 or Rule 24b-2 of the Securities Exchange Act of 1934 as amended, as applicable (or any other applicable regulation relating to the confidential treatment of information) so that there be omitted from the materials that are publicly filed any information that the receiving Party reasonably requests to be deleted, unless in the opinion of the disclosing Party’s legal counsel such Confidential Information is legally required to be fully disclosed.

 

ARTICLE 9                            REPRESENTATIONS AND WARRANTIES

 

9.1                               Representations and Warranties . Each of the Parties hereby represents and warrants as of the Effective Date as follows:

 

(a)                                  This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms. The execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

(b)                                  Each Party has not granted any right to any Third Party relating to its respective technology in the Field which would conflict with the rights granted to the other Party hereunder.

 

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

 

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(c)                                   Each Party Controls all of the rights, title and interest in and to its know-how and its Patents which are licensed hereunder.

 

9.2                               Grünenthal Patent Warranty. Grünenthal warrants as of the Effective Date that it owns the entire right, title and interest in the Grünenthal Patents and that it has given to OMP all material Information requested by OMP prior to the Combined Territories License Agreement Effective Date relating to Grünenthal Patent, Grünenthal Know-How and/or CG-5503 and Product in Grünenthal’s possession or under its Control. Nothing in this Agreement shall be construed as a warranty that Grünenthal Patents are valid or enforceable or that their exercise does not infringe any patent rights of Third Parties.

 

9.3                               Grünenthal Product Warranty. Grünenthal represents and warrants that the Product in Phase II clinical trials as of the Combined Territories License Agreement Effective Date which is being licensed hereunder has the chemical structure shown in Exhibit 1.3 .

 

9.4                               OMP Diligence Warranty. OMP acknowledges and agrees that it has received access to information relating to CG-5503 that OMP deemed necessary to conduct and complete its due diligence relating to CG-5503 to its satisfaction. OMP acknowledges and agrees that Grünenthal has answered all questions of OMP relating to the due diligence of CG-5503, and OMP warrants that it has diligently reviewed all such information, including the Information and information relating to Grünenthal Patent Rights, Grünenthal Know-How and/or CG-5503 and Product provided by Grünenthal.

 

9.5                               OMP Patent Warranty. OMP warrants that as of the Combined Territories License Agreement Effective Date, to the best of their knowledge there are no OMP Patents or Patents of its Affiliates that would be infringed by the Commercialization of CG-5503 in its pharmaceutical formulation as of the Combined Territories License Agreement Effective Date, absent a license granted. If OMP obtains knowledge of such OMP Patents after the Combined Territories License Agreement Effective Date, OMP warrants that it will not enforce any OMP Patents which exist as of the Combined Territories License

 

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

 

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Agreement Effective Date to prevent the Commercialization of CG-5503 by Grünenthal in the Grünenthal Territory during the Term and thereafter.

 

9.6                               No Conflicting Rights. From and after the Combined Territories License Agreement Effective Date, neither Party will grant any right to any Third Party relating to its respective technology in the Field which would conflict with the rights granted to the other Party hereunder.

 

9.7                              No Other Representations or Warranties . EXCEPT AS SPECIFICALLY AND EXPRESSLY SET FORTH IN THIS ARTICLE 9 , NO PARTY MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AT LAW OR IN EQUITY, RELATING TO ITS INTELLECTUAL PROPERTY AND/OR KNOW-HOW, OR ANY OTHER INFORMATION DISCLOSED, REVEALED OR OTHERWISE MADE AVAILABLE BY ONE PARTY TO THE OTHER UNDER THIS AGREEMENT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY AS TO VALUE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR FOR ORDINARY PURPOSES, OR ANY OTHER MATTER.

 

9.8                               No Liability for Consequential Damages . Neither Party shall be liable to the other for incidental or consequential damages arising at of or related to the subject matter of this Agreement.

 

ARTICLE 10                     MANAGEMENT OF REGULATORY APPROVAL PREPARATION (“RAP”) AND COMMERCIALIZATION

 

10.1                        Steering Committee .

 

(a)                                  Establishment of Steering Committee . Within [***], the Parties have established a Steering Committee (“ SC ”), which is composed of four (4) representatives of each Party who were appointed (and may be replaced at any time) by such Party on written notice to the other Party. The representatives from each Party will collectively have one vote in decisions, with decisions made by unanimous vote.

 

(b)                                  Authority . The Parties agree that, in voting on matters as described in this Article 10 , it shall be conclusively presumed that each voting member of the

 

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

 

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SC has the authority and approval of such member’s respective senior management in casting his or her vote and that decisions of the SC made in accordance with this Article 10 shall be binding upon each of the Parties; provided, however, that the SC, other than as expressly provided for herein, shall not have the authority to amend or modify this Agreement. The members of the SC will undertake reasonable efforts to obtain from their respective senior management the authority to cast their vote prior to the respective meeting, however, in no event later than 10 days after such meeting.

 

(c)                                   Delegation. The SC shall create such subcommittees or subteams as it may deem necessary or appropriate and may at the same time define the composition and rules of such sub-committees. One such subcommittee that shall be created by the SC shall be a RAP Subcommittee ( RSC ”) which shall be described hereinafter. The RSC shall be led by a representative chosen by Grünenthal.

 

(d)                                  SC Responsibilities . The SC shall be responsible for overseeing the RAP of Products in OMP´s Territory and the EU.  In addition, the SC shall review and approve any recommendations from the RSC with respect to the modification, amendment or departure from the RAP Plan, RAP Budgets for OMP Territory and the EU, RAP Costs and any other financial activities. Any modifications to the RAP Plan (including the work plans, budgets and timelines therein) approved at a SC meeting shall be considered approved and shall constitute an amendment upon SC ratification of the meeting minutes related thereto.

 

(e)                                   Dispute Resolution . If the members of the SC cannot reach in its meeting a unanimous decision with respect to RAP matters referred to it for approval or the Parties can not agree to meet within [***] of the initial request for a meeting to resolve the dispute, such undecided matters shall be promptly referred to the Management Committee for decision unless otherwise agreed by the SC.

 

Unless otherwise agreed by the MC, the meeting of the Management Committee shall be convened by each of its members after co-ordination with the other member

 

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

 

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and shall take place within [***] after referral to the Management Committee. The meeting shall take place at the place of the Party not hosting the last SC meeting. If the members of the Management Committee cannot reach in its meeting a unanimous decision with respect to RAP matters referred to it for approval or if the meeting does not take place within the timeframe foreseen above, for such undecided matters the procedures for “Final decision-making/Disputes RAP Matters” set forth below in Section 10.2 shall apply.

 

10.2                        Final Decision-Making/Disputes RAP Matters .  If the Management Committee cannot agree in its meeting, or unless otherwise agreed by the MC, the final decision on such undecided matters shall be made by Grünenthal for OMP Territory and Grünenthal Territory, except as to Excepted RAP Matters.  “ Excepted RAP Matters ” are defined as:

 

(i)                                      increasing the budget for the RAP Plan by more than 10% of the previously approved RAP Budget,

 

(ii)                                   altering the RAP Plan in a manner which would change indication(s) for which a Product is being Prepared For Regulatory Approval,

 

(iii)                                terminating or suspending a Phase III Clinical Trial prior to completion in accordance with its protocol,

 

(iv)                               material issues relating to the initial label, revised label or changes to the label of Product, or

 

(v)                                  alteration of a protocol which would change one or more endpoints outlined in such protocol and which would materially delay the filing of a Drug Approval Application with a Regulatory Authority.

 

If a final decision cannot be reached at the Management Committee with respect to any of the Excepted RAP Matters, which have been referred to that level for resolution or approval, the status quo shall be maintained with respect to Excepted RAP Matters items 10.2 (i) as far as it concerns OMP Territory and Grünenthal Territory and with respect to Excepted RAP Matter 10.2 (ii). As to Excepted RAP

 

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

 

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Matters item 10.2 (iii), the Phase III Clinical Trial shall be terminated for the affected Territory if an external expert advisory panel recommends termination or the FDA or the EMA orders termination of the Phase III Clinical Trial or suspended for the affected Territory if any safety issue arise that require to immediately put the Phase III clinical trial on hold, otherwise for the not affected Territory the status quo shall be maintained. With respect to Excepted RAP Matter (iv), no label or labeling, or changes to the label of labeling, will be finalized until the Parties reach mutual agreement. As to Excepted RAP Matter item (v), endpoints shall be altered or changed, independent of its effect on timing, if recommended or mandated by a Regulatory Authority, otherwise the status quo shall be maintained.

 

10.3                        RAP Sub-Committee .

 

(a)                                  Establishment of RSC . After the Combined Territories License Agreement Effective Date, the Parties have established a RAP Subcommittee (“ RSC ”) to coordinate all activities with respect to the RAP of Products, within the budgets approved hereunder. The first meeting of the RSC has occurred.  The RSC shall be led by a representative chosen by Grünenthal.

 

(b)                                  RSC Responsibilities. The RSC shall be responsible, with the oversight and approval of the SC, for overseeing the Parties’ independent RAP activities hereunder, including, without limitation, coordinating all RAP to be conducted independently by OMP and/or Grünenthal pursuant to the RAP Plan for their respective territories and may propose modifications of the RAP Plan to the SC. The RSC will determine the allocation of costs between OOP and internal FTEs based on the principles of Exhibit 10.3(b) . Within its responsibilities, the RSC may decide on certain cost allocations of the annual budget within the limits of such budget. If actual costs of implementing the RAP Plan exceed the total amounts budgeted for expenditure during the relevant period, and will lead to an overage of the annual budget, the RSC will revise, provided that the Parties mutually agree, the RAP Plan and submit it in writing, with an explanation of the variance and the reasons therefore for approval to the SC. The RSC shall be responsible for implementation of the RAP Plan under the oversight of the SC.

 

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

 

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(c)                                   RSC Decision-making . The RSC will operate by consensus. In the event that the RSC members do not reach consensus with respect to a matter that is within the purview of the RSC herein, unresolved disputes will be referred promptly to the SC, where the matter will be dealt with as recited in Sections 10.1 (e)  and 10.2.

 

(d)                                  Accounting/Financial Reporting . Each Party will appoint a representative with expertise in the areas of accounting, cost allocation, budgeting and financial reporting to the RSC. Such representatives shall work under the direction of the SC to provide services to and consult with the RSC in order to address the financial, budgetary and accounting issues which arise in connection with the RAP Plan.

 

(e)                                   RSC Reporting. The RSC shall monthly prepare and provide the SC with minutes of its meetings summarizing the progress of the RAP.

 

10.4                        Commercialization Team .

 

(a)                                  Formation of the Commercialization Team . Within [***], a Commercialization Team ( CT ) has been created, comprised of an equal number of representatives of each Party. The CT shall, during the RAP of Product, coordinate (i) with the RSC those activities deemed necessary for a successful Commercialization of Products in the OMP Territory and Grünenthal Territory, as outlined herein, upon Regulatory Approval. The commercial matters shall be to develop a publication and scientific symposia strategy, develop and implement a strategy for Phase IV Clinical Trials, establishment of key opinion leaders, coordinate and create a calendar of key scientific and clinical meetings which both Parties plan to attend, develop, search and select a single, worldwide trademark to be used by both Parties if Grünenthal exercises its option in Section 5.1(a) , create a unified promotional message to target audiences, and all other commercial matters agreed to by the Parties. One representative from each Party shall be designated as that Party’s “ Commercialization Team Leader to act as the primary CT contact for that Party.

 

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

 

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(b)                                  Dispute Resolution . If the members of the CT cannot reach in its meeting a unanimous decision with respect to commercialization matters referred to it by the RSC or SC or the Parties, then such dispute shall be escalated to the managing director of Grünenthal and President of OMP for their consideration and agreement; and, if they are unable to agree after negotiation, the matter shall default to the status quo. If there is no previously agreed to status quo on a particular issue, then each Party will have final decision making authority for such issue in its respective Territory. In no event, will any such irresolvable disputes arising in the CT be resolved under the dispute resolution process of Sections 10.1(e) and 10.2 .

 

ARTICLE 11                     REGULATORY APPROVAL PREPARATION (“RAP”)

 

11.1                        RAP Plans .

 

(a)                                  RAP Plans . The Parties have attached as Exhibit 1.63 an initial RAP Plan ( RAP Plan 1.63 ), with the 2004 First Amendment as Exhibit 1.63.1 , an additional RAP Plan ( RAP Plan 1.63.1 ). RAP Plan 1.63 and 1.63.1 are prepared and drafted by Grünenthal, revised by Grünenthal in response to comments received from OMP and agreed to by Parties which shall set out the details of the RAPs of the Product on a world-wide basis.

 

(b)                                  RAP Plan Modifications . The Parties acknowledge that the RAP Plan, as the RAP progresses needs to be revised and modified by the RSC and approved by the SC with regard to OMP Territory and Grünenthal Territory, with Grünenthal taking the lead in the modification process of RAP Plan 1.63 and OMP taking the lead in the modification process of RAP Plan 1.63.1. Disputes shall be resolved as set out in Sections 10.1(e), 10.2; and 10.3(c) . Each such revised RAP Plan shall include, without limitation, detailed plans for, as applicable, the RAP activities and clinical studies of Product, designation of which Party is responsible for each task, staffing levels required to carry out such activities (which levels shall be reasonably necessary for the attainment of the RAP goals, as applicable) including specification of a budget setting forth the estimated expenditures required (RAP Costs and FTE Resources) to

 

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

 

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carry out such activities, and a detailed budget covering each activity that will be continued or initiated during the next calendar year. If a specific activity would best be undertaken by a Third Party contractor the RAP Plan shall indicate which Party shall manage, account for and be liable for such Third Party contractor.

 

11.2                        Exclusive RAP Relationship . It is understood and agreed by the Parties that, during the Term, the Parties shall work exclusively with each other to Prepare for Regulatory Approval of the Product solely in accordance with and under the terms of this Agreement.

 

11.3                        RAP Efforts .

 

(a)                                  The Parties agree to coordinate and to carry out all RAP activities as agreed in the RAP Plan. RAP activities will, to the extent practicable, utilize the then-prevailing infrastructure and expertise of each Party in a given activity or with respect to a specific RAP activity.

 

11.4                        RAP Responsibilities . Consistent with its responsibilities under this Agreement and the RAP Plan (particularly, those recited in Article 11 ), each Party agrees to perform the following, subject to applicable law, including confidentiality, data protection and privacy restrictions,

 

(a)                                  provide to the other Party all preclinical data, assays and associated materials, protocols, procedures and any other information in such Party’s possession that the other Party deems reasonably necessary for the RAP of Product;

 

(b)                                  conduct all agreed studies and other activities assigned to the respective Party, including human clinical studies for Product; and

 

(c)                                   file required communications with Regulatory Authorities in either the OMP Territory or the EU as applicable and, as provided for by Section 11.6 and as otherwise reasonably requested by the other Party, consult with the other

 

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

 

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Party in preparing such Drug Approval Applications and communications with the relevant Regulatory Authorities in the Territory.

 

11.5                        Clinical Trials .

 

(a)                                  The Parties will conduct, sponsor, support and/or assist in any clinical trial for the Product, in accordance with the most current version of the RAP Plan and shall provide each other forthwith with all Information gathered in OMP Territory and Grünenthal Territory, including but not limited to clinical data, database information and reports related to clinical trials for the Product reasonably requested by the other Party in a mutually agreed upon format compatible to both Parties’ systems. The overall amount of patients included in the various studies and the distribution of patients between the OMP Territory and Grünenthal Territory shall be determined by the Parties after considering the Parties’ discussions with Regulatory Authorities in order to support Drug Approval Applications. The Parties will make reasonable efforts to split the overall amount of patients [***] between OMP´s Territory and the EU for Products developed in accordance with RAP Plan 1.63 as long as reasonable for the project (time to market, expertise, costs etc.). All Information, including but not limited to clinical data, database information and reports related to clinical trials for the Product shall be owned by Grünenthal, and during the Term OMP shall have full use of all such Information for the Product, solely for purposes provided for under this Agreement. Subject to Articles 7 and 8 and notwithstanding the foregoing, either Party may use its know-how resulting from the Information for any purpose. All clinical data, database information and reports from such clinical trials for Products shall be in English, centralized and held at Grünenthal, with a duplicate set provided to OMP, for deposit at a site of its own selection.

 

(b)                                  Both Parties shall inform each other of Post Approval Commitments in their territory and allow the other Party an opportunity to review and comment on how such Party intends to meet such Post Approval Commitments prior to finalization of same. Such comments of the other Party shall be considered in

 

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

 

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good faith. Section 11.6(e)  and Section 11.6(g)  shall apply mutatis mutandis. Notwithstanding the above, the decision of the Party in which such Post Approval Commitment is requested shall be final. The decision shall be communicated to the other Party in due time.

 

With regard to OMP Territory and the EU the following shall apply:

 

(i)                                      If the Parties agree on a joint Phase IIIB, Phase IIIB2, or Phase IV study relating to the Product developed under RAP Plan 1.63, the costs for such study will be [***] and if the Product was developed under RAP Plan 1.63.1, [***] of the costs associated with the such study. Each Party shall have full use of all Information and documents arising out of such studies.

 

(ii)                                   With regard to the EU the costs for all Post Approval Commitments will be borne by Grünenthal if the Post Approval Commitments are requested from the Regulatory Authorities in the EU and by OMP if the Post Approval Commitments are requested from the Regulatory Authorities in the OMP Territory.

 

(iii)                                The costs for a jointly agreed upon Core Pediatrics Program, other than Post Approval Commitments, shall be shared between OMP and Grünenthal so that [***]. Each Party shall have full use of all Information and documents arising out of such studies.

 

(iv)                               Each party shall bear the costs for the compilation and execution of a Risk Management Plan required for its territory.

 

(v)                                  If the Parties do not agree on a joint study, the Party conducting such Core Pediatric Program, Phase IIIB, Phase IIIB2 and Phase IV study alone, shall bear all costs related to such study and shall own all Information including, but not limited to, data and clinical reports arising out of such study. The Party conducting any Post Approval Commitments shall own all Information arising out of such Post Approval Commitment. Any such clinical trial shall be the sole and

 

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

 

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exclusive property of the Party conducting such study. No person or entity, including the other Party, shall have any right, title or interest therein. However, all completed Pediatric Studies, Phase IIIB, Phase IIIB2, Phase IV studies and Post Approval Commitments shall be included free of charge as supportive in subsequent Drug Approval Applications for the Product. With respect to any Pediatric Study, Phase IIIB, Phase IIIB2 and Phase IV study or Post Approval Commitment conducted by a Party alone, if a Regulatory Authority requests access to or review of data or reports owned by that Party, that Party shall provide to the other Party free of charge such data solely for the purpose of satisfying the request of the Regulatory Authority. Notwithstanding the foregoing, adverse event reporting shall apply to any Core Pediatric Program, Phase IIIB, Phase IIIB2 and Phase IV studies, and Post Approval Commitment. Notwithstanding the foregoing, with respect to the clinical trial KF 5503/68 Part I, the following shall apply:

 

[***]

 

(vi)                               The non-sponsoring party may elect to engage in such study and share the costs up to the date of the first patient enrollment in a clinical study or in the case of other nonclinical studies, the date on which data is first collected in the study without additional costs. Thereafter, the other Party may use data or know-how arising out of any such study either as a submission to a Regulatory Authority for an extension of the label of the Product (other than solely as requested by a Regulatory Authority) or to support any Commercialization or Promotional activities with respect to any Product for such purposes only if that Party pays to the sponsoring Party an amount equal to [***], unless otherwise agreed to. However, the Parties agree that data or know-how arising out of such study may be used by the other Party free of charge, only and to the extent it is in response to an unsolicited request as reasonably evidenced.

 

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

 

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With regard to Grünenthal Territory other than the EU, Grünenthal shall bear all costs in connection with Phase IIIB, IIIB2, Phase IV Studies, Core Pediatric Program and Post Approval Commitment.

 

With regard to Grünenthal Territory other than the EU, the Parties shall obtain the data and know-how of Phase IIIB, Phase IIIB2 and Phase IV Studies and Post Approval Commitments free of charge.

 

11.6                        INDs and Drug Approval Applications .

 

(a)                                  With regard to OMP Territory Grünenthal shall transmit and has transmitted the FDA Form 1571 and attachment for section 13 ( Exhibit 11.6 (a), 1 ) and a letter to the FDA ( Exhibit 11.6 (a), 2 ) stating that Grünenthal transfers and assigns IND 61,345 to J&J PRD. Consequently J&J PRD as of the date of the letter will become the official and responsible sponsor of IND 61,345.

 

Simultaneously with the above mentioned letters of Grünenthal J&J PRD shall send and has sent a letter to the FDA (addressed to the Division Director) ( Exhibit 11.6 (a), 3 ) with copies of said letter to Grünenthal GmbH and Grünenthal USA, Inc. confirming that Grünenthal GmbH has agreed to transfer IND 61,345 to J&J PRD and that J&J PRD accepts this transfer along with acknowledging full responsibility for the maintenance of said IND as prescribed under CFR 21 section 312 except as defined in section 13 of the respective Form 1571. Such letter shall also contain the statement that J&J PRD grants to Grünenthal GmbH and/or its US Affiliate, Grünenthal Inc., One Pluckemin Way, Bedminister, New Jersey 07921, the right of reference to IND 61,345 and the statement that Grünenthal maintains safety responsibility as defined in section 13 of the respective Form 1571. In addition this letter shall be accompanied by an executed FDA Form 1571 signed by J&J PRD which assigns J&J PRD as sponsor.

 

OMP shall take any and all necessary steps to comply with the documents referred to in this Section 11.6 (a)  to FDA granting Grünenthal and/or its US Affiliate a right of reference to IND 61,345 with respect to any INDs, Drug Approval Applications, and Regulatory Approvals with regard to Products. In

 

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

 

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no event, Grünenthal shall take any action relating to the Product if a negative effect on the safety, efficacy or the commercial potential of the Product can be reasonably anticipated. OMP may revoke the right of reference to IND 61,345 only in case of the entire termination of this Agreement pursuant to Section 15.2(b) (termination by OMP for breach) or 15.3 .

 

(b)                                  Consistent with the then effective RAP Plan in regard to timing, content and scope of INDs and Drug Approval Applications and Regulatory Approvals, OMP shall be responsible for obtaining and filing

 

(i)                                      further submissions to the referenced transferred IND with regard to OMP Territory, including, but not withstanding, Drug Approval Applications (NDAs) and any and all manners of the seeking of Regulatory Approval(s) for the Product(s) in the OMP Territory, provided, however, no such IND Submission, Drug Approval Application and/or Regulatory Approval may be filed or sought unless they are part of the RAP Plan. OMP shall bear the respective registration fees and all electronic document processing costs.

 

Grünenthal shall be responsible for obtaining and filing INDs and Drug Approval Applications and seeking Regulatory Approvals for the Product in the Grünenthal Territory and shall bear the respective registration fees and all electronic document processing costs.

 

Prior to submitting any IND or Drug Approval Application, the Parties shall consult and coordinate in preparing such filings and in reviewing and determining the content and scope thereof. Each Party shall have the right to review and comment (prior to filing with a Regulatory Authority) on all INDs, Drug Approval Applications or Regulatory Approvals in the OMP Territory and EU of the other Party in accordance with specific timelines or other arrangements agreed upon by the SC, and each Party’s comments will be given all due consideration. The same shall apply for all changes (except for immaterial changes) or amendments of INDs, Drug Approval Applications and Regulatory Approvals and request of a Party to the other Party to amend

 

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

 

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existing INDs. If requested by either Party in writing the INDs and/or applications for a Drug Approval Application and/or application for a Regulatory Approval for Products developed in accordance with RAP Plan 1.63 and/or Products developed in accordance with RAP Plan 1.63.1 shall be split in order to pursue separately with regard to such Products. Grünenthal shall own all INDs, Drug Approval Applications, and Regulatory Approvals for Product in the Grünenthal Territory and OMP shall own all INDs, Drug Approval Applications, and Regulatory Approvals in the OMP Territory, provided, however, such INDs, Drug Approval Applications and Regulatory Approvals are part of the RAP Plan. Each Party shall provide copies of all regulatory documents to the other Party for the United States and the EU, including a copy of any Regulatory Approval of the Product in the United States and the EU, to be used for registration purposes by Grünenthal in the Grünenthal Territory or OMP in the OMP Territory. A centralized electronic repository shall be created and maintained by Grünenthal containing all data generated by the Parties relating to Products in a format to be agreed upon and which is compatible to both Parties’ systems. When requested in writing the Parties shall discuss the transfer of safety responsibility.

 

(c)                                   OMP shall use the INDs, Drug Approval Applications and Regulatory Approvals only

 

(i)                                      consistent with the then effective RAP Plan in regard to timing, content and scope,

 

(ii)                                   consistent with the Agreement.

 

Except as permitted in Sections 11.5 and 11.6 , OMP shall not use such INDs or any drug Approval Application or Regulatory Approval as the basis for, or refer to them in any IND other than the referenced transferred IND, any Approval Applications or Regulatory Approvals that are not part of the RAP Plan, nor permit any third party to do so, and OMP shall not use the data in said INDs, Drug Approval Application or Regulatory Application as part of

 

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

 

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another or other INDs, Drug Approval Applications or Regulatory Approvals that are not part of the RAP Plan, nor permit any third party to do so.

 

(d)                                  Each Party shall be responsible for and comply with all legal requirements in connection with the holding of INDs including but not limited to reporting responsibilities and annual updates.

 

(e)                                   The Parties shall to the extent allowable by law have the right to participate in all meetings and/or telephone conversations with Regulatory Authorities in the OMP Territory and EU and the Parties shall inform each other in due time thereof in advance giving the other party all details necessary. The number of participants and the role of the participants shall be decided by each Party under due consideration of the other Party’s concern, if any, and under due consideration of the issues discussed in the meeting and/or telephone conference. All contacts including face-to-face meetings and telephone conversations with the Regulatory Authorities in the OMP Territory and the EU in which the other Party does not participate shall be summarized in writing and transmitted immediately to the other Party and in no case later than within [***] after such contact has taken place.

 

(f)                                    As applicable and where possible in due time in advance and during the entire Term of this Agreement, each Party, for their respective Territory, shall notify each other of the existence of any material data which have to be reported to the respective Regulatory Authorities in the OMP Territory or the EU, any material documents or reports which have to be filed with the FDA or any other Regulatory Authority in the EU under this Agreement or material communication with such Regulatory Authority. If not possible in due time in advance the Parties shall inform each other at the latest within [***] of such filing or communication and, upon request, shall provide a copy of such document(s) to the other Party.

 

(g)                                   Except as mentioned in the preceding paragraph and with the exception of immaterial communications any and all other planned communications of the Parties with the Regulatory Authorities in the OMP Territory and the EU, oral

 

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

 

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or in writing, must be discussed with the other Party, prior to any actual contact with such Regulatory Authority. All drafts of material communication(s) with the Regulatory Authority in the OMP Territory and the EU shall be transmitted in a timely manner in order to give the other party the opportunity to comment such communication(s).

 

(h)                                  In case of any disagreement between the Parties on planned communications as mentioned above the Parties shall refer the issue to the SC and the SC shall become responsible for deciding such issues. If the members of the SC cannot reach in its meeting an unanimous decision with respect to the communications the dispute resolution of Section 10.1 (e) and 10.2 shall apply.

 

(i)                                      On request of Grünenthal OMP shall promptly conduct all steps necessary in order to have the concerned IND transferred back to Grünenthal in the respective Territory in case OMP has decided to discontinue activities in the respective Territory with respect to Product development in accordance with RAP Plan 1.63 or the overall activities allocated to OMP in the RAP Plan or OMP intends to withdraw the concerned IND.

 

(j)                                     Other than with respect to transfers of any or all of the following to Grünenthal upon the termination of this Agreement as provided in this Agreement, at no time during the Term of this Agreement or after expiration of this Agreement, and other than to designated Affiliates, shall OMP transfer title or otherwise attempt in any manner to dispose of any such INDs, Drug Approval Applications or Regulatory Approvals for Products in the OMP Territory and OMP shall maintain any and all such INDs, Drug Approval Applications and Regulatory Approvals.

 

11.7                        Regulatory Meetings and Communications .

 

(a)                                  Within [***], the RSC has met and agreed upon processes and procedures for sharing information needed to support each Party’s respective regulatory

 

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

 

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responsibilities, including without limitation, a global safety database relating to Product.

 

(b)                                  Immediately after confirmation of any meetings with Regulatory Authorities in OMP Territory or the EU, each Party shall notify the other Party of such meeting and both Parties shall have the right to attend any such meetings with Regulatory Authorities set up by the other Party to ensure that the Product is consistently Prepared for Regulatory Approval. The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party’s or contractor’s site and facilities, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting with a Regulatory Authority at the conclusion of such site inspection. If such attendance would result in the disclosure to the other Party of confidential information or trade secrets unrelated to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering the unrelated subject matter. To the extent either Party receives written or material oral communication from the FDA or any other Regulatory Authority in the EU relating to any activities subject to this Agreement, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable and in no case later than three (3) business days thereafter.

 

(c)                                   Adverse Event Reporting . Notwithstanding anything herein to the contrary, the Parties shall handle adverse events reporting relating to Products as set forth in Exhibit 11.7(c) . Further, the Parties agree and acknowledge that OMP may provide information specifically related to OMP Technology, which it obtains under this Section 11.7 to OMP’s other clients developing and/or marketing other products using OMP Technology.

 

11.8                        Territory Specific RAP Costs .

 

(a)                                  Any cost or expense incurred or to be incurred by Grünenthal as a result of regulatory approval preparation activities, to obtain Regulatory Approval outside the OMP Territory and the EU or a territory otherwise included by

 

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

 

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mutual agreement in the current version of the RAP Plan (“ Territory Specific RAP ”), shall not be shared under this Agreement.

 

(b)                                  All Territory Specific RAP must be communicated from Grünenthal to OMP prior to conducting any RAP activities regardless of whether such Territory Specific RAP is included as a RAP Cost under Section 6.2 . Grünenthal shall take any comments of OMP into consideration. All Information including, but not limited to, data and clinical reports arising out of any Territory Specific RAP, including, without limitation, any clinical trial, submitted to the Parties pursuant to this Section 11.8 , shall be the sole and exclusive property of Grünenthal and no person or entity, including OMP, shall have any right, title or interest therein. However, OMP shall have free of charge full use of all such Information for the Product including but not limited to using such Information as a submission for indication or extension to a Regulatory Authority or to support any Commercialization or Promotion activities with respect to any Product. All such Information relating to Product shall be included in the centralized electronic repository set up by the Parties for use by either Party for the fulfillment of regulatory submissions or legal obligations. However, if, with respect to any activities by OMP, a Regulatory Authority requests access to or review of data or reports owned by Grünenthal, Grünenthal shall provide OMP with such data to comply with the request of the Regulatory Authority under such conditions as will protect its legitimate ownership rights. Notwithstanding the foregoing, adverse event reporting shall apply to any Territory Specific RAP.

 

11.9                        Transfer of Materials . During the Term hereunder, the Parties anticipate that each Party will transfer certain of its proprietary materials to the other Party. Each Party agrees that it will use such materials of the other Party only for the purposes of this Agreement, hereunder, and will not transfer such materials to any Third Party without the consent of the other Party except with respect to Grünenthal’s Affiliates and licensees and to OMP´s Affiliates engaged in RAP that need to obtain the proprietary material for the fulfillment of this Agreement. Ownership of proprietary materials made or assembled by a Party

 

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

 

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or a Third Party during and in furtherance of this Agreement, shall be determined in accordance with Article 7 . Each Party shall have the right to transfer such material to Third Parties under the form of a material transfer agreement agreed upon by the Parties. All transfers of materials pursuant to this Agreement may be charged to the common account as a RAP Cost of the Party transferring such material.

 

11.10                 Compliance with GLP/GCP/GMP . All of the RAP activities, including all tasks specified by the RAP Plan and its associated work plans, shall, in accordance with timelines set forth therein, and shall be done in accordance with GLP, GMP and GCP, as applicable. Each Party is prepared, at its sole discretion, to assist the other Party with regard to GLP, GCP and GMP compliance. With respect to any facility or site at which a Party conducts RAP pursuant to this Agreement, including, where commercially reasonable and within the control of the other Party, Third Party facilities or sites, each Party shall have the right, at its expense, upon reasonable written notice and during normal business hours, to inspect such site and facility and any records relating thereto as is reasonably necessary to verify the other Party’s compliance with the terms of this Agreement relating to GLP, GCP and GMP. Such inspection shall be subject to the confidentiality provisions of this Agreement. Each Party agrees, to the extent possible, to include in any contract or other written arrangement with a Third Party relating to such facilities and sites a clause permitting the other Party to exercise its rights under this Section 11.10 .

 

11.11                 Failure to perform Duties of RAP Plan . In the event that a Party fails to carry out any of its duties or responsibilities under the RAP Plan, due to reasons within the control of such Party, and such failure shall have continued for [***] after written notice thereof was provided to such failing Party, then the non-failing Party may assume control of the disrupted part of the RAP of Product in the OMP-Territory or EU, as applicable, except for filing of any Drug Approval Applications which shall remain the failing Party’s responsibility. The failing Party shall continue to be responsible for its Proportionate Share of the RAP Costs for RAP being conducted by the non-failing Party, along with an

 

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

 

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[***] of such RAP Costs of the activities of which the non-failing Party has assumed control, as compensation to the non-failing Party for the disruption to the RAP Plan caused by the failing Party. If the non-failing Party has not assumed control over the disrupted part of the RAP of Product and the failure to carry out the duties or responsibilities of the failing Party has continued for [***] after receipt of the above mentioned written notice this failure shall be considered a material breach in accordance with Section 15.2 . Such breach may entitle the non-breaching Party to terminate immediately at the end of such [***] period without notice period. If such breach relates to an OMP Territory such right to terminate shall only apply to the OMP Territory, as applicable.

 

11.12                 Combination Products and Products based on Improvements. If it is the intention to jointly develop a Combination Product or Products based on Improvements, the Parties shall cooperate in essentially the same manner as for Product, containing CG-5503 as the sole active pharmaceutical ingredient under this Agreement so that Combination Products and Products based on Improvements can be promptly registered in each Party’s Territory. The Parties will discuss in good faith if and how to achieve this goal. If the Parties’ cannot agree, the Party conducting such development alone, shall bear all costs related to such development and all Information including, but not limited to, data and clinical reports arising out of such development, including, without limitation, any clinical trial, shall be the sole and exclusive property of the Party conducting such development and no person or entity, including the other Party, shall have any right, title or interest therein. The non-sponsoring Party shall have the option to use data or know-how arising out of any such development as a submission to a Regulatory Authority only if that Party pays to the sponsoring Party an amount equal to [***], unless otherwise agreed to by the Parties.

 

ARTICLE 12                     ADF FORMULATION

 

12.1                        Decision of an abuse deterrent form (“ ADF ”) Formulation.

 

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

 

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(a)                                  The Parties anticipate that the Product will initially be Commercialized using a Grünenthal formulation currently being used in clinical trials. However, in the event that the filing of a Drug Approval Application in the OMP Territory for the ADF Formulation, (which has been selected according to Section 12.1(b) ), would not delay the filing of a Drug Approval Application for the Grünenthal formulation currently used in clinical trials by more than six (6) months, then OMP may file its Drug Approval Application for the selected ADF Formulation.

 

(b)                                  At present, Grünenthal is working on its own ADF Formulations of the Product and is considering further suitable technologies of abuse deterrent formulations. OMP is considering an OMP-ADF-Formulation incorporating OMP Technology. It is the aim of the Parties to agree, as soon as all relevant data regarding the decision criteria described below are available, on one worldwide ADF Formulation for Commercialization. In advance of agreeing upon a worldwide ADF Formulation, each Party shall, independently of the other Party and objectively, evaluate its own ADF Formulation regarding all main decision criteria. The main decision criteria are:

 

(i)                                      abuse deterrence potential of various administration routes,

 

(ii)                                   feasibility of bio-equivalence to the current formulation (non ADF),

 

(iii)                                development costs,

 

(iv)                               costs of goods,

 

(v)                                  scope of patent protection,

 

(vi)                               development time,

 

(vii)                            regulatory aspects,

 

(viii)                         legal aspects,

 

(ix)                               improvement of overall activity profile.

 

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

 

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Thereafter, the Parties shall exchange simultaneously the results of the above mentioned evaluation in written form and shall discuss the merits of each ADF Formulation.

 

12.2                        Development of ADF Formulation .

 

(a)                                  The Parties have agreed to jointly develop and use the Grünenthal-ADF-Formulation but if the Parties would agree later jointly to use the OMP-ADF-Formulation worldwide,

 

(i)                                      OMP shall be responsible for all CM&C activities related to the OMP-ADF-Formulation on a worldwide basis. The RAP Plan will be modified, the Parties shall be responsible for its RAP. The RAP Costs incurred after such decision will be shared equally by the Parties. Such RAP will be considered as OOP which will be shared equally by the Parties. The responsibility for the manufacture and supply of the OMP-ADF-Formulation in the Grünenthal Territory shall be based solely upon Grünenthal’s exercise of its option in accordance with Section 12.2(a)(v)(a) .

 

(ii)                                   Licenses for Commercialization . OMP hereby grants to Grünenthal and its Affiliates an exclusive (even as to OMP), paid-up license, within the Field under the OMP ADF-Formulation Patents, Independent ADF Formulation Improvement Patents Controlled by OMP and OMP Know-How, to Commercialize Products within the Grünenthal Territory. The license to Commercialize Products based on any OMP ADF-Formulation Patent is subject to a mutual agreement under Section 12.1(b)  to develop the OMP ADF-Formulation. Grünenthal shall not have any right to sell, offer for sale, distribute and have sold Product under the OMP ADF-Formulation Patents and OMP Know-How for any indication outside the Field.

 

(iii)                                Licenses for Production . OMP hereby grants to Grünenthal and its Affiliates a non-exclusive, paid-up license, within the Field under the

 

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

 

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OMP ADF-Formulation Patents, Independent ADF Formulation Improvement Patents Controlled by OMP and OMP Know-How, to make Products worldwide solely for the purpose to Commercialize Products within the Grünenthal Territory. The license to make Products based on OMP ADF-Formulation Patents is subject to a mutual agreement under Section 12.1(b)  to develop the OMP-ADF-Formulation and Grünenthal’s election under Section 12.2(a)(v)(a)  to manufacture the OMP ADF-Formulation.

 

(iv)                              License for RAP . OMP hereby grants to Grünenthal and its Affiliates a non-exclusive, paid up worldwide license, within the Field, under the OMP ADF-Formulation Patents, Independent ADF Formulation Improvement Patents Controlled by OMP and OMP Know-How for use in carrying out RAP of the Product. The license to carrying out RAP of the Product based on OMP-ADF-Formulation Patents is subject to a mutual agreement under Section 12.1(b)  to develop the OMP ADF-Formulation.

 

(v)                                  Manufacturing of OMP-ADF-Formulation . In the event that both OMP and Grünenthal elect to Commercialize Product using the OMP-ADF-Formulation, Grünenthal shall have the option to:

 

(a)                                  install a manufacturing equipment train for the OMP-ADF-Formulation in a Grünenthal facility or a facility of a Grünenthal Affiliate for use exclusively for manufacturing Product and/or Combination Product. OMP shall use and shall cause any applicable Third Party (in as far as OMP is able to achieve such rights) to support Grünenthal in the installment of such manufacturing equipment train and the provision of Grünenthal with the necessary technical training assistance. Such support shall be charged to Grünenthal on a transparent, standard allocated cost basis, or

 

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

 

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(b)                                  have OMP manufacture Product with the OMP-ADF-Formulation for Grünenthal at an OMP, OMP Affiliate, or licensor of OMP-ADF-Formulation facility in the EU, if available. Such supply shall be at OMP`s Fully Allocated Manufacturing Cost, without any internal mark-ups . In the case OMP has terminated the Agreement, OMP will supply Product to Grünenthal at OMP´s Fully Allocated Manufacturing Cost. Additionally, in case of such supply by OMP a royalty of [***] on Net Sales shall be paid by Grünenthal until the last to expire of any OMP-ADF-Formulation Patent which claims the Product. In the event that OMP manufactures Product for Grünenthal, then Grünenthal shall have the right to have a limited number of employees present to oversee such manufacturing work, to inspect OMP´s manufacturing facility, review OMP´s standard operating procedures for manufacturing and inspect related records, upon reasonable notice, during normal business hours, under appropriate conditions of confidentiality. Notwithstanding anything to the contrary in this Agreement, in the event that OMP supplies Product to Grünenthal hereunder, such supply shall be pursuant to the terms of a mutually acceptable supply agreement to be entered into between the Parties, which agreement shall contain reasonable, industry-standard terms. OMP and Grünenthal shall negotiate in good faith a supply agreement on reasonable terms and conditions.

 

For the purpose of this Section 12.2(a)(v) , OMP shall include its Affiliates.

 

(vi)                               The Party carrying out RAP of the selected ADF Formulation shall regularly exchange information as set forth, but not limited to, timelines, technology, allocated capacity, dissolution profiles, PK etc., regarding the ADF Formulation and its RAP.

 

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

 

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(b)                                  The Parties have agreed jointly on July 23, 2004 to jointly develop and use the Grünenthal-ADF-Formulation in the Grünenthal Territory and OMP Territory. With regard to the above mentioned decision of the Parties the following shall apply:

 

(i)                                      Grünenthal shall be responsible for all CM&C activities related to the supply of Grünenthal-ADF-Formulation for the Grünenthal Territory.  OMP shall be responsible for all CM&C activities related to the supply of Grünenthal-ADF Formulation for the OMP Territory.  The RAP Plan will be modified and the Parties shall be responsible for its RAP on a Grünenthal Territory and OMP Territory-wide basis. The RAP Costs incurred after such decision will be shared equally by the Parties for the OMP Territory and Grünenthal Territory. Each Party shall be responsible for manufacture and supply of the Grünenthal-ADF-Formulation in its Territory. Such RAP for OMP Territory and Grünenthal Territory will be considered an OOP which will be shared equally by the Parties.

 

(ii)                                   Licenses for Commercialization . Grünenthal hereby grants to OMP and its Affiliates an exclusive (even as to Grünenthal), paid-up license, within the Field under the Grünenthal ADF-Formulation Patents and Independent ADF Formulation Improvement Patents Controlled by Grünenthal to Commercialize Products within the OMP Territory. OMP shall not have any right to Commercialize Product under the Grünenthal ADF-Formulation Patents for any indication outside the Field. OMP shall not have any right to commercialize Product under the Grünenthal-ADF-Formulation Patents outside OMP Territory.

 

(iii)                                Licenses for Production . Grünenthal hereby grants to OMP and its Affiliates a non-exclusive, paid-up license, within the Field under the Grünenthal ADF-Formulation Patents, and Independent ADF Formulation Improvement Patents Controlled by Grünenthal; to make Products worldwide for the purpose to Commercialize Products within

 

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

 

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the OMP Territory under the Commercial Supply Manufacturing License.

 

(iv)                               License for RAP . Grünenthal hereby grants to OMP and its Affiliates a non-exclusive, paid up worldwide license, within the Field, under the Grünenthal ADF-Formulation Patents and Independent ADF Formulation Improvement Patents Controlled by Grünenthal for use in carrying out RAP of the Product.

 

(v)                                  Information Exchange . The Party carrying out RAP of the selected ADF Formulation shall regularly exchange information as set forth, but not limited to, timelines, technology, allocated capacity, dissolution profiles, PK etc., regarding the ADF Formulation and its RAP.

 

(c)                                   If the Parties have not agreed to jointly use one ADF Formulation worldwide, both Parties shall have the right to develop their own ADF Formulation and there shall be no dispute resolution mechanism available under Section 10.1(e) and 10.2 relating to selection of the ADF Formulation. If Grünenthal elects not to use the OMP-ADF-Formulation, then Grünenthal shall not be responsible for any development costs associated with the development thereof and vice versa. In such case, the development of different ADF Formulations for the respective Territories should in no case delay the joint Core RAP Program, other than as allowed in Section 12.1(a) . Any Party has the right at any time to use the ADF Formulation of the other Party by equally sharing the development costs thereof incurred after the decision not to jointly use one ADF Formulation worldwide, and for future development costs by [***].

 

12.3               Miscellaneous

 

(a)                                  The Parties are aware that the ADF Formulation applies only for Products developed in accordance with RAP Plan 1.63.

 

(b)                                  It is the intention of the Parties to develop a 1.63.1 ADF. Each Party shall inform the other Party of its 1.63.1 ADF in accordance with Section 12.1(b) .

 

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

 

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(c)                                   OMP hereby grants Grünenthal and its Affiliates an exclusive (even as to OMP) license within the Field under OMP 1.63.1 Patents and OMP Know How, to Commercialize Products within the Grünenthal Territory; a non exclusive license within the Field under the OMP 1.63.1 Patents and OMP Know How, to make Products worldwide solely for the purpose to Commercialize Products within the Grünenthal Territory; a non exclusive license within the Field under the OMP 1.63.1 Patents and OMP Know How for use in carrying out RAP of the Product in Grünenthal Territory, the terms and conditions of which shall be negotiated in good faith by the Parties.

 

(d)                                  Grünenthal hereby grants to OMP and its Affiliates an exclusive (even as to Grünenthal) license within the Field under the Grünenthal 1.63.1 Patents and Grünenthal Know How to Commercialize Products within the OMP Territory; a non exclusive license within the Field under the Grünenthal 1.63.1 Patents and Grünenthal Know How, to make Products worldwide solely for the purpose to Commercialize Products within the OMP Territory; a non exclusive license within the Field under the Grünenthal 1.63.1 Patents and Grünenthal Know How for use in carrying out RAP of the Product in OMP Territory, the terms and conditions of which shall be negotiated in good faith by the Parties.

 

(e)                                   If the Parties are developing a 1.63.1 ADF in parallel the decision making process of Section 12.1(b)  shall apply.

 

(f)                                    If a Party has a 1.63.1 ADF developed by a third party the Party engaging the third party shall obtain a worldwide license on such 1.63.1 ADF with the right to sublicense this 1.63.1 ADF to the other Party to this Agreement for use in its Territory at the same conditions as the engaging Party unless otherwise agreed by the Parties.

 

(g)                                   If the Parties cannot agree on a worldwide 1.63.1 ADF and consequently OMP uses its own 1.63.1 ADF the COGS Cap as per Section 6.7 shall not apply.

 

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

 

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12.4                        Licenses for Independent ADF Formulation Improvement Patents controlled by OMP and Grünenthal ADF Formulation Patents

 

(a)                                  OMP grants to Grünenthal a worldwide non-exclusive, paid up license under any Independent ADF Formulation Improvement Patent Controlled by OMP for any product made, used or sold by Grünenthal and/or its Affiliates which product would be covered by at least one claim issued from at least one of the following US Patent Applications Publ. No.  [***].

 

(b)                                  Grünenthal grants to OMP a worldwide non-exclusive, paid-up license under any Grünenthal ADF Formulation Patent Controlled by Grünenthal for any product other than the Product made, used or sold by OMP and/or its Affiliates provided such product would not be covered by any claims issued from the following US Patent Applications Publ. No.  [***].

 

(c)                                   The licenses granted to Grünenthal and OMP respectively pursuant to Section 12.4 (a) and (b)  include the right to sublicense to Affiliates or to licensees of Grünenthal and OMP respectively.

 

ARTICLE 13                     INDEMNIFICATION

 

13.1                        Indemnification . Each Party (the “ Indemnifying Party ”) shall be solely and completely responsible and liable for, and shall indemnify, defend and hold the other Party (the “ Indemnified Party ”) harmless from and against, any and all claims (whether made by a Third Party or the Indemnified Party), losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses), but expressly excluding consequential, special and punitive damages (unless paid to a Third Party as part of a Third Party claim) and lost profits (collectively, the “ Losses ”), arising out of:

 

(a)                                  the conduct of the research and development program other than clinical trials contemplated herein in the Indemnifying Party’s Territory;

 

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

 

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(b)                                  the conduct of clinical trials by the Indemnifying Party acting as Responsible Party for Clinical Trials, no matter in which Territory such clinical trials take place;

 

(c)                                   the manufacture, use, handling, storage, sale, distribution or other disposition of Products (including clinical trial samples) by or on behalf of the Indemnifying Party; except, in the case of clauses (a), (b) and (c) above, to the extent that such Losses do not also result from the willful misconduct or gross negligence of the Indemnified Party.

 

13.2                        Indemnification Procedures .

 

(a)                                  In the event that either Party receives notice of a claim with respect to a Product in the Territory, such Party shall inform the other Party as soon as reasonably practicable. The Parties shall confer how to respond to the claim and how to handle the claim in an efficient manner.

 

(b)                                  In the event that a Party is seeking indemnification under Section 13.1 , it shall inform the indemnifying Party of a claim as soon as reasonably practicable after it receives notice of the claim, shall permit the indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration), shall cooperate as requested (at the expense of the indemnifying Party) in the defense of the claim, and shall not settle or compromise the claim without the express written consent of the indemnifying Party.

 

13.3                        Insurance . Beginning on the date that the first Product is first administered in a human clinical trial in any country in the Territory, each Grünenthal and OMP shall each have and maintain, each at its own cost, the following insurances:

 

(a)                                  Commercial General Liability, and Product Liability (maintained for a period of at least five (5) years after the expiration or termination of this Agreement ) providing at a minimum, insurance coverage for bodily injury, property damage and liability with respect to the contractual indemnification provisions provided under this Agreement). The policy shall have a limit of no less than twenty five million dollars (US-$25,000,000) for each occurrence of bodily injury up to a maximum of two hundred million dollars (US-$200,000,000) per calendar year, which may include a self-insured retention , and

 

(b)                                  Foreign Local Coverage: Where required by law, the Party acting as Responsible Party for Clinical Trials of the clinical trial in such country of the

 

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

 

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Territory shall obtain foreign local coverages in an amount that, at a minimum, satisfies the legal requirements of that jurisdiction.

 

(c)                                   Policy Conditions: All policies under (a), (b) and (c) above shall provide that coverage under such policy shall not be suspended, voided, canceled, non-renewed, reduced in scope or the above mentioned limits, except after at least twenty five (25) days written notice has been given to the other Party.  In addition, each Party shall provide to the other Party a copy of the certificate(s) of insurance for each policy procured and maintained pursuant to Sections 13.3(a) through (c)  above.

 

In no event shall a Party’s failure to request or obtain any such certificate of insurance from the other Party serve to waive that Party’s right to insist upon full compliance with the other Party’s insurance procurement and maintenance obligations pursuant to this Section 13.3 .

 

The provisions of Section 13.3 shall apply accordingly in case of Commercialization of Products; provided, however, that in case of Section 13.3(b)  the Party which is required by the laws of the respective jurisdiction is responsible to provide such local coverage.

 

ARTICLE 14                     [Reserved]

 

ARTICLE 15                     TERM AND TERMINATION

 

15.1                        Term .

 

(a)                                  This Agreement commenced on the Effective Date and shall remain in effect until the expiration, on a country-by-country basis, of OMP’s or Grünenthal´s obligation to pay current royalties for the last Commercialized Product or future Products under development, unless earlier terminated as provided in this Article 15 (“ Term ”).

 

Thereafter, subject to the remainder of Article 15 , OMP shall have a fully paid up, non-exclusive license to make, use and sell Product under the Grünenthal Patents claiming the Commercialized Products, its use, or the manufacture

 

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

 

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thereof in the OMP Territory. Rights under all other Grünenthal Patents (the “ Other Rights ) shall revert to Grünenthal except as provided in Section 15.1(b) , and OMP shall promptly transfer to Grünenthal all Drug Approval Application and Regulatory Approvals including all clinical data associated therewith if and when OMP is no longer selling any Product hereunder. Grünenthal shall be free to Prepare Regulatory Approval of and Commercialize Product without any limitations; provided, however, that if Grünenthal desires to continue to Prepare Regulatory Approval of or Commercialize the Product utilizing the OMP-ADF-Formulation (provided the Parties had already agreed to jointly use the OMP-ADF-Formulation pursuant to Section 12.1(b) ) the licenses and option or rights with regard to manufacture and supply, as set forth in Section 12.2 , shall survive.

 

(b)                                  In case of an ongoing development of Product by OMP and provided such development is conducted using Commercially Reasonable and Diligent Efforts, the Agreement shall not expire, and the Other Rights shall not revert to Grünenthal until OMP´s obligation to pay royalties for the last Product (which may be the Product in development) have ended, unless earlier terminated as provided in this Article 15 . For purposes of this Article 15 , the term “OMP” shall include each Affiliate or assignee of any rights or obligations of OMP and/or each Affiliate referenced herein.

 

Upon the expiration of the Agreement, in the event that there is no Product in development hereunder by OMP and no royalties being paid hereunder on any Product being sold by OMP, all rights to Grünenthal Patents shall revert to Grünenthal, except those Grünenthal Patents in which an OMP employee or agent is a joint inventor. In connection with such Grünenthal Patents, OMP shall retain a worldwide, non-exclusive license outside the Field.

 

OMP Patents shall be retained by OMP except that OMP shall grant to Grünenthal a worldwide exclusive license to Commercialize Product provided Grünenthal is developing or Commercializing Product. Such license shall be royalty bearing at a rate of [***] Net Sales of Product in OMP Territory.

 

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

 

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15.2                        Termination For Breach .

 

(a)                                  Either Party may terminate this entire Agreement or this Agreement partly with regard to Products developed in accordance with the RAP Plan 1.63.1 in the event the other Party shall have materially breached or defaulted in the performance of any of its material obligations hereunder with regard to the OMP Territory, and such default shall have continued for [***] after written notice thereof was provided to the breaching Party by the non-breaching Party. Any termination shall become effective at the end of such [***] period unless the breaching Party (or any other party on its behalf) has cured any such breach or default prior to the expiration of the [***] period.

 

A termination only with regard to Products developed in accordance with RAP Plan 1.63 is excluded.

 

(b)                                  In the event of termination of this Agreement by OMP, in its entirety or partly with regard to Product developed in accordance with RAP Plan 1.63.1 pursuant to this Section 15.2 , the licenses and rights granted to OMP in Article 2 and 12 (if the Parties have previously agreed to jointly develop the Grünenthal-ADF-Formulation) and all obligations of OMP related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. In addition, if such termination occurs during RAP, then OMP may assume control of all RAP activities of the Product(s) terminated that are relevant or necessary to the filing of any Drug Approval Applications in the OMP Territory and Grünenthal shall provide OMP with all necessary assistance and documentation for OMP to carry out such RAP activities.

 

(c)                                   In the event of termination of this Agreement by Grünenthal in its entirety or partly with regard to Product developed in accordance with RAP Plan 1.63.1 pursuant to this Section 15.2 , the licenses and rights granted to Grünenthal in Articles 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal related to

 

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

 

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Product(s) terminated shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Application and Regulatory Approvals including all clinical data associated therewith in case of entire termination of this Agreement or the respective INDs (if IND relates solely to Product terminated), Drug Approval Applications and Regulatory Approvals including all clinical data associated therewith in case of partly termination. Grünenthal shall not be free to Prepare Regulatory Approval of or Commercialize Product in OMP Territory until this Agreement is terminated with regard to the OMP Territory.

 

Grünenthal shall be free to prepare Regulatory Approval of and Commercialize Product in OMP Territory without any limitations upon termination of this Agreement in its entirety.

 

15.3                        Termination For Bankruptcy . Notwithstanding Section 18.19 , either Party hereto shall have the right to terminate this entire Agreement or this Agreement partly with regard to Products developed in accordance with the RAP Plan 1.63.1 (excluding termination only with regard to Products developed in accordance with the RAP Plan 1.63) forthwith by written notice to the other Party

 

(a)                                  if the other Party is declared insolvent or bankrupt by a court of competent jurisdiction,

 

(b)                                  if a voluntary or involuntary petition in bankruptcy is filed in any court of competent jurisdiction against the other Party and such petition is not dismissed within [***] after filing, or

 

(c)                                   if the other Party shall make or execute an assignment of substantially all of its assets for the benefit of creditors.

 

(d)                                  In the event of termination of this Agreement by OMP in its entirety or partly with regard to Product developed in accordance with RAP Plan 1.63.1, pursuant to this Section 15.3 , the licenses and rights granted to OMP in Articles 2 and 12 (if the Parties have previously agreed to jointly develop the

 

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

 

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Grünenthal-ADF-Formulation) and all obligations of OMP related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. In addition, if such termination occurs during RAP, then OMP may assume control of all RAP activities of the Product(s) terminated that are relevant or necessary to the filing of any Drug Approval Applications in the OMP Territory and Grünenthal shall provide OMP with all necessary assistance and documentation for OMP to carry out such RAP activities.

 

(e)                                   In the event of termination of this Agreement by Grünenthal in its entirety or partly with regard to Product developed in accordance with RAP Plan 1.63.1, pursuant to this Section 15.3 , the licenses and rights granted to Grünenthal in Article 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal related to Product(s) terminated shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Application and Regulatory Approvals including all clinical data associated therewith in case of entire termination of this Agreement or the respective INDs (if IND relates solely to Product terminated), Drug Approval Applications and Regulatory Approvals including all clinical data associated therewith in case of partly termination. Grünenthal shall not be free to Prepare Regulatory Approval of or Commercialize Product in OMP Territory until this Agreement is terminated in its entirety .

 

15.4                        [Reserved]

 

15.5                        Termination After the Start of Phase III.

 

(a)                                  Either Party may terminate this Agreement

 

(i)                                      in its entirety, or

 

(ii)                                   partly for the OMP Territory with regard to Product

 

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

 

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developed in accordance with RAP Plan 1.63.1

 

after start of Phase III of the Product(s) and prior to First Commercial Sale of that Product(s) in OMP Territory, upon [***] prior written notice. In case of such termination, the terminating Party shall still be responsible for its share of planned budgeted OOP during the [***] notice period.

 

The terminating Party shall also continue to provide [***] of its plan FTE resources for a period of [***] after the date of the notice of termination and thereafter [***] of its plan FTE resources for a further [***] after which time no further FTE`s shall be due for the [***].

 

(b)         (i)                                      If OMP terminates this Agreement under Section 15.5(a)  in its entirety, the licenses and rights granted to Grünenthal in Article 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Application and Regulatory Approvals including all clinical data associated therewith. Grünenthal shall be free to Prepare Regulatory Approval of and Commercialize Product without any limitations.

 

(ii)                                   If OMP terminates this Agreement under Section 15.5(a)  partly with regard to Products developed in accordance with the RAP Plan 1.63.1 the licenses and rights granted to Grünenthal in Article 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal shall pertaining to Products developed in accordance with RAP Plan 1.63.1 revert to Grünenthal and OMP shall promptly transfer to Grünenthal the respective INDs (if IND relates solely to terminated Product), Drug

 

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

 

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Approval Applications and Regulatory Approvals including all clinical data associated therewith. Grünenthal shall not be free to Prepare Regulatory Approval of or Commercialize Product in OMP Territory until this Agreement is terminated in its entirety.

 

(c)                                   If Grünenthal terminates this entire Agreement under Section 15.5(a) , but OMP decides to pursue the Regulatory Approval Preparation of Product, OMP shall obtain a worldwide exclusive license under Grünenthal Patents and Grünenthal Know-How to make, use and sell Product and the licenses granted to Grünenthal under Section 2.2(c)(ii)  shall apply to OMP mutatis mutandis, at the following royalty rates:

 

(i)                                      In the OMP Territory, the Earned Royalty rates as recited in this Agreement shall apply; and

 

(ii)                                   For the rest of the world outside the OMP Territory:

 

·                                           at a royalty rate of [***] if Grünenthal terminates before [***] of total planned patients of Phase III have been recruited, or

 

·                                           at a royalty rate of [***] , if Grünenthal terminates after [***] of total planned patients of Phase III have been recruited.

 

In the event OMP elects to Commercialize Product using ADF Formulation of Grünenthal, an additional royalty of [***] on Net Sales for the OMP Territory and [***] for the Grünenthal Territory shall be paid to Grünenthal.  If Grünenthal terminates this Agreement under Section 15.5(a)  only with regard to Products developed in accordance with RAP Plan 1.63.1 and OMP decides to pursue the Regulatory Approval Preparation with regard to such Products, Grünenthal shall retain its rights with regard to the Grünenthal Territory and OMP shall not obtain the world-wide exclusive license referred to in Section 15.5(c)  first paragraph above. In the event OMP elects to Commercialise such Products using Grünenthal-ADF-Formulation an additional royalty of [***] on Net Sales for the OMP Territory shall be paid to Grünenthal. In case OMP subsequently ceases the Regulatory Approval Preparation of the Product for

 

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

 

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the OMP Territory this Agreement is automatically terminated in its entirety for the OMP Territory.

 

(d)                                  Termination during Commercialization .  OMP may terminate this Agreement

 

(i)                                in its entirety, or

 

(ii)                             partly for the OMP Territory with regard to Product developed in accordance with RAP Plan 1.63.1

 

during Commercialization upon [***] prior written notice.

 

If OMP terminates this Agreement under this Section 15.5(d) , the licenses and rights granted to Grünenthal in Article 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal with respect to such Product terminated shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Application and Regulatory Approvals including all clinical data associated therewith in case of entire termination of this Agreement or the respective INDs (if IND relates solely to terminated Product), Drug Approval Applications and Regulatory Approvals including all clinical data associated therewith in case of partly termination. Grünenthal shall have the option to request OMP to transfer all rights to such terminated Product back to Grünenthal at any time during the notice period upon [***] written notice. Grünenthal shall not be free to Prepare Regulatory Approval of or Commercialize Product in OMP Territory until this Agreement is terminated in its entirety. Grünenthal shall be free to Prepare Regulatory Approval of and Commercialize any Product without any limitations upon termination of this Agreement in its entirety.

 

15.6                       Termination By OMP .

 

(a)                                  OMP may terminate this Agreement, at any time, in its entirety upon 30 days prior written notice as a result of :

 

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

 

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(i)                                      material data regarding the safety or efficacy of the Product which arise during the Regulatory Approval Preparation of the Product that convincingly indicate a materially and adversely different safety or efficacy profile as compared to the target profile of that Product as of the Combined Territories License Agreement Effective Date, or the effective date of the 2004 First Amendment, as applicable;

 

(ii)                                   there is a materially adverse regulatory development relating to the approvability in the United States of a Product compared to the registration requirements of that Product as of the Combined Territories License Agreement Effective Date, or the effective date of the 2004 First Amendment, as applicable.

 

OMP may terminate this Agreement on a Product by Product basis upon 30 days prior written notice only if

 

(i)                                      material data regarding the safety or efficacy of a Product which arise during the Regulatory Approval Preparation of the Product convincingly indicate a materially and adversely different safety or efficacy profile as compared to the target profile of that Product as of the Combined Territories License Agreement Effective Date, or the effective date of the 2004 First Amendment, as applicable;

 

(ii)                                   there is a materially adverse regulatory development relating to the approvability in the United States of a Product compared to the registration requirements of that Product as of the Combined Territories License Agreement Effective Date, or the effective date of the 2004 First Amendment, as applicable;

 

and such material data as referred to in (i) above or materially adverse regulatory development as referred to in (ii) above apply only to such Product terminated. In case such material data and material adverse regulatory development apply also to other Products OMP may terminate this Agreement only in its entirety.

 

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

 

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(b)                                  In the event of termination by OMP under Section 15.6(a) , OMP shall have no obligation to make payments relating to Regulatory Approval Preparation Costs of the Product(s) terminated which accrue following the effective date of termination, including but not limited to FTE costs, except, however, all initiated and committed OOP which shall be shared. In addition, the licenses and rights granted to Grünenthal in Article 2 and 12 (if the Parties have previously agreed to jointly develop the OMP-ADF-Formulation) and all obligations of Grünenthal related to such license as set forth in Articles 6 and 7 and all relevant definitions in Article 1 shall survive termination. All rights granted by Grünenthal related to Products terminated shall revert to Grünenthal and OMP shall promptly transfer to Grünenthal all INDs, Drug Approval Applications and Regulatory Approvals including all clinical data associated therewith in case of entire termination of this Agreement or the respective INDs (if IND relates solely to terminated Product), Drug Approval Applications and Regulatory Approvals including all clinical data associated therewith in case of partly termination. Grünenthal shall not be free to Prepare Regulatory Approval of or Commercialize Product in OMP Territory until this Agreement is terminated in its entirety. Grünenthal shall be free to Prepare Regulatory Approval of and Commercialize any Product without any limitations upon termination of this Agreement in its entirety.

 

15.7                        Mutual Termination. In case of a common decision by the SC to terminate the Regulatory Approval Preparation in its entirety for reasons referred to in Section 15.6(a) , both Parties will equally share the cost of discontinuation and all licenses hereunder shall terminate.

 

15.8                        Change of Control .

 

(a)                                  In the event of a Change of Control of OMP .  In the event that substantially all of OMP’s assets are sold, or greater than 35% of OMP’s voting securities are transferred (whether by stock sale, merger, consolidation, reorganization, recapitalization or otherwise with respect to OMP or Johnson & Johnson) to any Third Party, other than Affiliates of OMP, during RAP of Product, joint

 

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

 

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RAP shall continue, but the Excepted RAP Matters under Section 10.2 shall no longer exist and all final decisions shall be made by Grünenthal.

 

(b)                                  In the event of a Change of Control of Grünenthal . In the event of an Grünenthal Change in Control (defined below) during RAP of Product, joint RAP shall continue but all final decisions relating to RAP of Product shall no longer be made by Grünenthal but instead will be made by OMP and the Excepted RAP Matters under Section 10.2 shall continue to exist.

 

(i)                                      Grünenthal Change of Control shall mean any transaction or series of related transactions in which a Third Party (other than Affiliates of Grünenthal or the existing owner of Grünenthal [***]) acquires or becomes the ultimate beneficial owner of (x) more than fifty percent (50%) of the outstanding voting securities of Grünenthal or the surviving entity, whether by merger, consolidation, reorganization, tender offer or similar means, or (y) all or substantially all of the assets of Grünenthal.

 

(ii)                                   [***].

 

15.9                        [Reserved]

 

15.10                 Surviving Rights . Without limiting this Article 15, Sections 2.1(d), 7.4, 7.7, and 12.4 and Articles 1, 8, 9, 13 and 18 shall survive the expiration and any termination of this Agreement for any reason. The termination of this Agreement for any reason whatsoever shall be without prejudice to any obligations or rights on the part of either Party which have accrued prior to such termination and shall not affect or prejudice any provision of this Agreement which is expressly or by implication provided to come into effect on, or continue in effect after such termination.

 

15.11                 Accrued Rights, Surviving Obligations . Termination, relinquishment or expiration of the Agreement for any reason shall be without prejudice to any obligations which shall have accrued prior to such termination, relinquishment or expiration, including, without limitation, the payment obligations under Article 6 hereof and this Article 15 and any and all damages arising from any breach hereunder. Such termination, relinquishment or expiration shall not

 

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

 

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relieve either Party from obligations that are expressly indicated to survive termination or expiration of the Agreement. Notwithstanding anything to the contrary in this Agreement, in the event of termination by a Party after the date of filing of a Regulatory Approval in such Party’s Territory, such Party will cooperate with the other Party, to the extent requested by such other Party, in transferring such Regulatory Approval (or filing thereof) to such other Party at such other Party’s cost (unless such termination was due to the breach of this Agreement by, insolvency of, or voluntary termination by such Party).

 

15.12                 [Reserved]

 

15.13                 Termination Not Sole Remedy . Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available except as agreed to otherwise herein.

 

ARTICLE 16                     DISPUTE RESOLUTION

 

16.1                        Dispute Resolution and Arbitration . In the case of any disputes between the Parties arising from this Agreement, and in case this Agreement does not provide a solution for how to resolve such disputes, the Parties shall discuss and negotiate in good faith a solution acceptable to both Parties and in the spirit of this Agreement. If after negotiating in good faith pursuant to the foregoing sentence, the Parties fail to reach agreement, then Grünenthal’s managing director and OMP´s chairman for pharmaceutical sector shall discuss in good faith an appropriate resolution to the dispute. If these executives fail, after good faith discussions undertaken in reasonable promptness, to reach an amicable agreement, then either Party may upon written notice to the other submit to binding arbitration pursuant to Section 16.2 .

 

16.2                        Arbitration. In the case of any dispute arising out of or in connection with this Agreement, the Parties shall negotiate in good faith within [***] days after written notice has been given by one Party to the other Party requesting such negotiations. Within this [***] day period, the Parties shall also consider to use

 

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

 

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mediation. If the Parties do not resolve their dispute within a period of [***] days after written notice was given, the dispute shall be finally settled by binding arbitration under the Rules of Arbitration of the International Chamber of Commerce by three (3) arbitrators, the chairperson of whom shall be appointed by the two party arbitrators. The seat of arbitration shall be Düsseldorf, Germany and the language of the proceedings shall be English. The Parties agree that any award or decision made by the arbitral tribunal shall be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction. The arbitral tribunal shall render its final award within [***] from the date on which the Request for Arbitration by one of the Parties wishing to have recourse to arbitration is received by the ICC Secretariat. The ICC Secretariat may extend this time limit pursuant to a reasoned request from the arbitral tribunal or on its own initiative if it decides it is necessary to do so. The costs of the arbitration shall be fixed and paid as specified in the award. The arbitral tribunal shall determine the dispute by applying the provisions of this Agreement and the governing law set forth in Section 18.7 . By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the jurisdiction of a competent court, the arbitral tribunal shall have full authority to grant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunal’s order to that effect.

 

ARTICLE 17                     [Reserved]

 

ARTICLE 18                     MISCELLANEOUS

 

18.1                        Relationship of Parties . For the purposes of this Agreement, each Party is an independent contractor and not an agent or employee of the other Party. Neither Party shall have authority to make any statements, representations,

 

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

 

92



 

nor commitments of any kind, or to take any action which shall be binding on the other Party, except as may be explicitly provided for herein or authorized in writing.

 

18.2                        Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, and all of which together shall be deemed to be one and the same instrument.

 

18.3                        Headings . All headings in this Agreement are for convenience only and shall not affect the meaning of any provision hereof.

 

18.4                       Binding Effect . This Agreement shall inure to the benefit of and be binding upon the Parties and their respective lawful successors and permitted assigns.

 

18.5                        Assignment . Neither Party may assign this Agreement without the prior written consent of the other Party, except that a Party may assign this Agreement in whole or in part to any Affiliate, provided that (i) the assigning Party remains obligated for its Affiliate´s performance of this Agreement, and (ii) the assigning Party provides prior written notice to the other Party of the anticipated assignment. Either Party may assign this Agreement to any party succeeding (by sale, merger, reverse merger or otherwise) to substantially all of the business and operations of such Party subject to the other Party´s right to terminate this Agreement pursuant to Article 15 .

 

18.6                        Amendment . This Agreement may be amended, supplemented, or otherwise modified at any time, but only by means of a written instrument signed by both Parties.

 

18.7                        Governing Law . This Agreement and the legal relations among the Parties shall solely be governed by and construed and any dispute arising out of or in connection with this Agreement shall solely be resolved in accordance with, German law, without regard to its conflicts of law rules.

 

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

 

93



 

18.8                        Severability . In the event of any provisions of this Agreement being or becoming ineffective or of any omission being discovered, the validity of the remaining provisions shall not thereby be affected. In place of the ineffective provisions or for the purpose of rectifying the omission a reasonable arrangement shall operate being the nearest legally possible approach to that which the parties hereto desired or would have desired in consideration of the spirit and object of this Agreement had they considered the point.

 

18.9               Entire Agreement . This Agreement, together with all Exhibits and Side Letters Nr. 1 through Amended Side Letter Nr. 21, attachments and schedules hereto, constitutes the entire agreement between the Parties with respect to the subject matter hereof; provided , however , that all rights and obligations of the Parties under the Combined Territories License Agreement arising prior to the Effective Date shall be governed by the Combined Territories License Agreement. For the sake of clarity, all rights and obligations of the Parties with respect to Canada and Japan arising on and after the Effective Date of this Agreement shall be governed by Canada/Japan License Agreement. The Parties acknowledge and agree that this Agreement, together with the Canada/Japan License Agreement, amends, restates, supersedes and terminates the Combined Territories License Agreement and all previous agreements between the Parties under the Combined Territories License Agreement.

 

18.10                 Advice of Counsel . OMP and Grünenthal have each consulted counsel of their choice regarding this Agreement, and each acknowledges and agrees that this Agreement shall not be deemed to have been drafted by one Party or another and will be construed accordingly.

 

18.11                 Consents Not Unreasonably Withheld . Whenever provision is made in this Agreement for either Party to secure the consent or approval of the other, that consent or approval shall not unreasonably be withheld, and whenever in this Agreement provision is made for one Party to object to or disapprove a matter, such objection or disapproval shall not unreasonably be exercised.

 

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

 

94



 

18.12                 Retained Rights . Nothing in this Agreement shall limit in any respect the right of either Party to conduct research and Regulatory Approval Preparation and to market products using such Party’s technology other than as herein expressly provided. Furthermore, nothing in this Agreement shall be construed to provide any license, implied or express, under any Patent Controlled by a Party, except to the extent of the express Products for the particular Regulatory Approval Preparation indications that are the subject of continuing joint Regulatory Approval Preparation and Commercialization pursuant to this Agreement.

 

18.13                 Force Majeure . Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses on account of failure of performance by the defaulting Party if the failure is occasioned by government action, war, terrorist act, fire, explosion, flood, strike, lockout, embargo, act of God, or any other similar cause beyond the control of the defaulting Party, provided that the Party claiming force majeure has exerted reasonable efforts to avoid or remedy such force majeure; provided, however, that in no event shall a Party be required to settle any labor dispute or disturbance. The Party giving notice shall be excused from such obligations hereunder as it is disabled from performing for so long as it is so disabled; provided, however, that Party commences and continues to take reasonable and diligent actions to cure or remedy such force majeure. In the event of any such force majeure event, the Parties shall meet promptly to determine an equitable solution to the effects of any such event. The term of the agreement shall not be extended by any force majeure.

 

18.14                 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

18.15                 No Implied Licenses . No rights to any other patents, know-how or technical information, or other intellectual property rights, other than as explicitly identified herein are granted or deemed granted by this Agreement. Except as

 

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

 

95



 

otherwise provided herein, no right, express or implied, is granted by the Agreement to use in any manner the name “Grünenthal” or “OMP”, or any other trade name or trademark of the other Party or its Affiliates in connection with the performance of the Agreement.

 

18.16                 Notices . All notices hereunder shall be in writing by mail, courier or personal delivery and shall be deemed given upon receipt thereof. All notices shall be given

 

- if to Grünenthal,

 

addressed to:

Grünenthal GmbH

52099 Aachen

Germany

Attention: CEO

 

With a copy to:

 

Grünenthal GmbH

52099 Aachen

Germany

Attention: CEO

 

- if to OMP:

 

addressed to:

Janssen Pharmaceuticals, Inc.

1125 Trenton-Harbourton Road,

Titusville, New Jersey, 08560

Attention: President

 

With a copy to: Office of General Counsel

 

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Attention: Corporate Law Leader, Medicines & Nutritionals

 

18.17                 Waiver . Except as specifically provided for herein, the waiver from time to time by either of the Parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Party’s rights or remedies provided in this Agreement.

 

18.18                 Compliance with Laws . The Parties shall comply with all applicable laws, rules, regulations and orders of the United States and applicable European

 

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

 

96



 

countries and supra-governmental organizations and all jurisdictions and any agency or court thereof in connection with this Agreement and the transactions contemplated thereby.

 

18.19                 Bankruptcy . All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, U.S. Code (the “ Bankruptcy Code ”), licenses and rights to “intellectual property” as defined under Section 101(60) of the Bankruptcy Code. The Parties agree that the other Party, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. Each Party agrees during the term of this Agreement to create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, of all such intellectual property. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against one Party under the Bankruptcy Code, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and same, if not already in its possession, shall be promptly delivered to the other Party

 

(a)                                  upon any such commencement of a bankruptcy proceeding upon written request therefore by the other Party, unless such Party elects to continue to perform all of its obligations under this Agreement, or

 

(b)                                  if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of such Party upon written request therefor by the other Party.

 

18.20                 Non-Solicitation. During the Term, neither Party shall solicit, without prior written consent, for employment any employees of the other Party that have been involved in the cooperation or the promotion, marketing and sale of the Product. The Parties agree that the term “solicit” shall not include general solicitations of employment not specifically directed towards a Party´s employees, newspaper or other periodical advertisements, or general searches conducted by professional recruiting firms.

 

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

 

97



 

18.21                 Contradictions . In case of contradiction of the wording between the body of this Agreement and the Exhibits and/or the Side Letters, the wording of the body of the Agreement shall take precedence over the Exhibits and the Side Letters.

 

ARTICLE 19                     GUARANTEE OF JOHNSON & JOHNSON, JOINT AND SEVERAL LIABILITY

 

19.1                        Johnson & Johnson, the parent corporation of OMP, hereby unconditionally and irrevocably guarantees the performance when due of any and all of the obligations of OMP and/or any other Johnson & Johnson Affiliate having obligations under this Agreement. Notwithstanding the foregoing, the guarantee set forth in this Section 19.1 shall automatically terminate, and shall be of no further force and effect, in the event that (i) this Agreement is assigned by OMP pursuant to Section 18.5 to any person or entity that is not a Johnson & Johnson Affiliate or (ii) OMP or another Johnson & Johnson Affiliate is otherwise no longer a party to this Agreement.

 

19.2                        Each company defined as OMP or to which obligations under this Agreement have been assigned shall be jointly and severally responsible for such obligation.

 

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

 

98



 

IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Agreement as a sealed instrument effective as of the Effective Date.

 

 

JANSSEN PHARMACEUTICALS, INC.

JANSSEN RESEARCH & DEVELOPMENT, LLC

 

 

 

 

By:

/s/ Michael Grissinger

 

By:

/s/ Michael Grissinger

 

 

 

 

 

Name:

Michael Grissinger

 

Name:

Michael Grissinger

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Authorized Signatory

 

 

 

 

 

Date:

January 12, 2015

 

Date:

January 12, 2015

 

 

GRÜNENTHAL GMBH

 

 

 

 

 

By:

/s/ Prof. Dr. Eric-Paul Pâques

 

By:

/s/ Dr. Alberto Grua

 

 

 

 

 

Name:

Prof. Dr. Eric-Paul Pâques

 

Name:

Dr. Alberto Grua

 

 

 

 

 

Title:

CEO

 

Title:

Chief Commercial Officer EU,
Australia and North America

 

 

 

 

 

Date:

2015-01-13

 

Date:

2015-01-13

 

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

 

[Signature Page to License Agreement (U.S.)]

 



 

Solely with respect to Article 19:

 

JOHNSON & JOHNSON

 

By:

/s/ Eric Jung

 

 

 

 

Name:

Eric Jung

 

 

 

 

Title:

Assistant Secretary

 

 

 

 

Date:

1/12/2015

 

 

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

 

[Signature Page to License Agreement (U.S.)]

 



 

EXHIBIT 1.3

 

to the License Agreement between Grünenthal GmbH and Ortho-McNeil

 

Pharmaceutical Inc.

 

CG-5503

 

Structural Formula:

 

Molecular Formula:                            C 14 H 24 CINO

 

Molecular Weight:                               257.80

Chemical Name:                 (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol;hydrochloride

 

Including the corresponding base of CG-5503; other salts of CG-5503; solvates of CG-5503, hydrates of CG-5503 and polymorphs of CG-5503.

 

(no further text on this page)

 

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

 



 

ORTHO-MCNEIL

 

THE JOHNSON & JOHNSON

PHARMACEUTICAL, INC.

 

PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC

 

 

 

 

 

By:

/s/Seth H.Z. Fischer

 

By:

/s/Harlan F. Weisman

 

 

 

 

 

Name:

Seth H.Z. Fischer

 

By:

Harlan F. Weisman

 

 

 

 

 

Title:

President

 

Title:

President

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

 

 

 

 

 

 

 

 

JOHNSON & JOHNSON

 

GRÜNENTHAL GMBH

 

 

 

 

 

 

 

 

 

 

By:

/s/Joseph C. Scodari

 

By:

/s/Dr. E.-P. Pâques

/s/M. Wirtz

 

 

 

 

 

 

Name:

Joseph C. Scodari

 

Name:

Dr. E.-P. Pâques

M. Wirtz

 

 

 

 

 

 

Title:

Company Group Chairman

 

Title:

Managing Director

Managing Director

 

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

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

 



 

EXHIBIT 1.22

 

to the License Agreement between Grünenthal GmbH and Ortho-McNeil

 

Pharmaceutical Inc.

 

“Fully Allocated Manufacturing Costs” shall mean

 

1.     Direct Material , where Direct Material shall be defined as

 

·       all raw material and packaging material

 

·       material shrinkage and overdosing within a limit of 5%

 

2.     Material Overheads , where Material Overheads shall be defined as

 

(in OMP’s calculation these costs may be components of the Manufacturing overhead expenses)

 

·       depreciation

 

·       cost of buildings

 

·       indirect labor

 

·       social insurance contributions

 

·       purchasing department

 

·       quality control for the direct material

 

·       development expenses for packing material

 

·       other overhead expenses (e.g. repairs, energy etc.)

 

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

 



 

3.     Manufacturing Expenses per Cost Centers, where Manufacturing Expenses per Cost Centers shall be defined as

 

·       direct labor

 

·       social insurance contributions

 

·       other direct costs (e.g. energy costs, depreciation etc.)

 

4.     Manufacturing Overhead Expenses per Cost Centers, where Manufacturing Overhead Expenses per Cost Centers shall be defined as

 

·       indirect labor

 

·       indirect material

 

·       maintenance and repair

 

·       cost of land and buildings

 

·       social insurance contributions

 

·       depreciation and imputed interest

 

·       other overhead expenses (e.g. energy, production manager, production schedule, etc.)

 

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

 



 

5.     Quality Control for Work in Process and Finished Goods, where Quality Control for Work in Process and Finished Goods shall be defined as

 

·       indirect labor and other overhead expenses in the cost centers

 

·       sample for quality control

 

6.     The OMP CNIS (costs not in standard) allocation will not be included

 

ORTHO-MCNEIL

 

THE JOHNSON & JOHNSON

PHARMACEUTICAL, INC.

 

PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC

 

 

 

 

 

By:

/s/Seth H.Z. Fischer

 

By:

/s/Harlan F. Weisman

 

 

 

 

 

Name:

Seth H.Z. Fischer

 

By:

Harlan F. Weisman

 

 

 

 

 

Title:

President

 

Title:

President

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

 

 

 

 

 

 

 

 

JOHNSON & JOHNSON

 

GRÜNENTHAL GMBH

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/Joseph C. Scodari

 

By:

/s/Dr. E.-P. Pâques

/s/M. Wirtz

 

 

 

 

 

 

Name:

Joseph C. Scodari

 

Name:

Dr. E.-P. Pâques

M. Wirtz

 

 

 

 

 

 

Title:

Company Group Chairman

 

Title:

Managing Director

Managing Director

 

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

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

 



 

EXHIBIT 1.29

 

to the License Agreement between Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.

Grünenthal Background Patent shall mean

 

Country

 

Patent No./App No.

 

Filing date

 

Status
(On
Effective
Date)

 

Term of protection

Argentina

 

254023

 

1995*

 

Patent

 

13.05.2015

Argentina

 

P990105399

 

1999*

 

Pending

 

 

Argentina

 

P020100687

 

2002 (German Prior.)

 

Pending

 

 

Argentina

 

P020104010

 

2002 (German Prior.)

 

Unpubl.

 

 

Australia

 

685644

 

1995*

 

Patent

 

21.07.2015

Austria (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Belgium (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Bolivia

 

5347

 

1995*

 

Patent

 

 

Brasil

 

PI9502390-9

 

1995*

 

Pending

 

 

Canada

 

2154424

 

1995*

 

Pending

 

 

Chech R.

 

286441

 

1995*

 

Patent

 

21.07.2015

Chile

 

1061-95

 

1995*

 

Pending

 

 

Chile

 

392

 

2002 (German Prior.)

 

Pending

 

 

Chile

 

2440-02

 

2002 (German Prior.)

 

Unpubl.

 

 

China

 

ZL 9510 89196

 

1995*

 

Patent

 

21.07.2015

Columbia

 

95032376

 

1995*

 

Patent

 

21.07.2015

Denmark (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Ecuador

 

PI 971220

 

1995*

 

Patent

 

 

Finland

 

953523

 

1995*

 

Pending

 

 

France (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

 

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

 



 

Germany

 

10059412.3

 

2000

 

Pending

 

 

Germany

 

10109763.8

 

2001

 

Pending

 

 

Germany

 

10152469.2

 

2001

 

Unpubl.

 

 

Germany

 

10200149.9

 

2002

 

Unpubl.

 

 

Germany

 

10146275.1

 

2001

 

Unpubl.

 

 

Germany

 

10224107.4

 

2002

 

Unpubl.

 

 

Germany

 

10254785.8

 

2002

 

Unpubl.

 

 

Germany (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Great-Britain (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Greece (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Hong-Kong

 

1005062

 

1995*

 

Patent

 

12.07.2015

Hungary

 

218481

 

1995*

 

Patent

 

17.07.2015

Ireland (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Israel

 

113901

 

1995*

 

Patent

 

20.05.2015

Italy (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Japan

 

Hei-7-186031

 

1995*

 

Pending

 

 

Korea

 

364465

 

1995*

 

Patent

 

22.07.2015

 

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

 



 

Country

 

Patent No./App No.

 

Filing date

 

Status
(On Effective Date)

 

Term of protection

Latvia (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Lithuania (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Luxemburg (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Malaysia

 

PI 9502089

 

1995*

 

Pending

 

 

Malaysia

 

PI20020713

 

2002 (German Prior.)

 

Pending

 

 

Malaysia

 

PI20023979

 

2002 (German Prior.)

 

Unpubl.

 

 

Mexico

 

95.3173

 

1995*

 

Pending

 

 

Monaco (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Netherlands (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

New-Zealand

 

272623

 

1995*

 

Patent

 

20.07.2015

Paraguay

 

41/95

 

1995*

 

Pending

 

 

PCT

 

PCT/EP01/13918

 

2001 (German Prior.)

 

Pending

 

 

PCT

 

PCT/EP02/02072

 

2002 (German Prior.)

 

Aband.

 

 

PCT

 

PCT/EP02/02169

 

2002 (German Prior.)

 

Pending

 

 

PCT

 

PCT/EP02/11806

 

2002 (German Prior.)

 

Unpubl.

 

 

PCT

 

PCT/EP02/11809

 

2002 (German Prior.)

 

Unpubl.

 

 

PCT

 

PCT/EP02/14790

 

2002 (German Prior.)

 

Unpubl.

 

 

PCT

 

PCT/EP02/10460

 

2002 (German Prior.)

 

Unpubl.

 

 

Peru

 

908

 

1995*

 

Patent

 

 

Peru

 

163

 

2002 (German Prior.)

 

Pending

 

 

Peru

 

1030

 

2002 (German Prior.)

 

Unpubl.

 

 

Philippines

 

50973

 

1995*

 

Pending

 

 

Philippines

 

1-1999-00658

 

1999*

 

Pending

 

 

 

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

 



 

Philippines

 

1-1999-00657

 

1999*

 

Pending

 

 

Philippines

 

1-1999-00656

 

1999*

 

Pending

 

 

Philippines

 

1-1999-00655

 

1999*

 

Pending

 

 

Philippines

 

1-1999-00654

 

1999*

 

Pending

 

 

Poland

 

181169

 

1995*

 

Patent

 

21.07.2015

Portugal (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Russia

 

2150465

 

1995*

 

Patent

 

19.07.2015

Slovenia (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

South-Africa

 

956118

 

1995*

 

Patent

 

21.07.2015

Spain (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Sweden (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Switzerland (EP)

 

693475

 

1995*

 

Patent

 

12.07.2015

Ukraina

 

41345

 

1995*

 

Patent

 

14.07.2015

Uruguay

 

13884

 

1995*

 

Patent

 

 

Uruguay

 

25555

 

1999*

 

Pending

 

 

USA

 

6248737

 

1995*

 

Patent

 

19.06.2018

USA

 

6344558

 

2001*

 

Patent

 

05.02.2019

Venezuela

 

1084

 

1995*

 

Pending

 

 

Venezuela

 

328

 

2002 (German Prior.)

 

Pending

 

 

Venezuela

 

1981

 

2002 (German Prior.)

 

Unpubl.

 

 

 


* All marked Patents and Applications claim priority of DE 4426245.0 filed 23.07.1994

 

(no further text on this page)

 

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

 



 

ORTHO-MCNEIL

 

THE JOHNSON & JOHNSON

 

 

 

 

PHARMACEUTICAL, INC.

 

PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC

 

 

 

 

 

By:

/s/Seth H.Z. Fischer

 

By:

/s/Harlan F. Weisman

 

 

 

 

 

Name:

Seth H.Z. Fischer

 

By:

Harlan F. Weisman

 

 

 

 

 

Title:

President

 

Title:

President

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

 

 

 

 

 

 

 

 

JOHNSON & JOHNSON

 

GRÜNENTHAL GMBH

 

 

 

 

 

 

 

 

 

 

 

By:

/s/Joseph C. Scodari

 

By:

/s/Dr. E.-P. Pâques

/s/M. Wirtz

 

 

 

 

 

 

Name:

Joseph C. Scodari

 

Name:

Dr. E.-P. Pâques

M. Wirtz

 

 

 

 

 

 

Title:

Company Group Chairman

 

Title:

Managing Director

Managing Director

 

 

 

 

 

 

Date:

February 21, 2003

 

Date:

February 21, 2003

 

 

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

 



 

EXHIBIT 1.63

 

to the License Agreement between Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc. Regulatory Approval Preparation Plan of CG-5503, non-abuse deterrent, slow release, matrix formulation.

 

[***](1)

 


(1) Twenty one pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 1.63.1

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.

 

[***](2)

 


(2) Fifteen pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 6.5

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.


[***](3)

 


(3) Two pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 10.3 (b)

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.

 

[***](4)

 


(4) Four pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 11.6 (a), 1

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical, Inc.

[***](5)

 


(5) Four pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 11.6 (a), 2

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.

Letter of Grünenthal about Transfer and Assignment of IND [***](6)

 


(6) Three pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 11.6 (a), 3

 

to the License Agreement between
Grünenthal GmbH and Ortho-McNeil Pharmaceutical Inc.

[***](7)

 


(7) Three pages omitted and filed separately with the Commission.

 

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

 



 

EXHIBIT 11.7 (c) 

 

to the License Agreement (U.S.)

 

ADVERSE EVENT REPORTING PROCEDURES FOR PRODUCT

 

Replaced by Global PV-Agreement (tapentadol) effective as of December 7, 2010

 

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

 



 

Side Letter No. 1 to the License Agreement
between Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
Dated February 21, 2003 (“Main Agreement”)

[***](8)

 


(8) Three pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 2
to the License Agreement
between Grünenthal GmbH and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

[***](9)

 


(9) Two pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 3 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

[***](10)

 


(10) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 4 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

[***](11)

 


(11) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 5 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](12)

 


(12) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 5 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](13)

 


(13) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 6 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](14)

 


(14) Four pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 7 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](15)

 


(15) Four pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 8 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](16)

 


(16) Four pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 9 to the License Agreement between
Grünenthal GmbH and Ortho-McNeil
Pharmaceutical, Inc., Johnson & Johnson Pharmaceutical Research and Development LLC
and Johnson and Johnson dated February 21, 2003 and subsequently amended (“Main Agreement”)

 

[***](17)

 


(17) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 10 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](18)

 


(18) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 11 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](19)

 


(19) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 12 to the License Agreement between
Grünenthal and Ortho-McNeil Pharmaceutical, Inc.
dated February 21, 2003 (“Main Agreement”)

 

[***](20)

 


(20) One page omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 13 to the License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson
Pharmaceutical Research and Development LLC (“J&JPRD”)
dated February 21, 2003 (“Main Agreement”)

 

[***](21)

 


(21) Three pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH
Side Letter No. 14 to the License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson
Pharmaceutical Research and Development LLC (“J&JPRD”)
dated February 21, 2003 (“Main Agreement”)

 

[***](22)

 


(22) Four pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH

Side Letter No. 15 to the Amended and Restated License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson
Pharmaceutical Research and Development LLC (“J&JPRD”)
dated December 29, 2006 (“Main Agreement”)

[***](23)

 


(23) Five pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH

Side Letter No. 16 (a) to the Amended and Restated License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil-Janssen Pharmaceuticals, Inc. / Johnson &
Johnson Pharmaceutical Research and Development LLC (“J&JPRD”) and as guarantor according to
Article 19.1 of the Agreement Johnson & Johnson (“Johnson & Johnson”),
dated December 29, 2006 (“Agreement”)

 

[***](24)

 


(24) Two pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 16 (b) to the Amended and Restated License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil-Janssen Pharmaceuticals, Inc. / Johnson &
Johnson Pharmaceutical Research and Development LLC (“J&JPRD”)
dated December 29, 2006 (“Agreement”)

[***] (25)

 


(25) Three pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH

Side Letter No. 16 to the Amended and Restated License Agreement between
Grünenthal GmbH (“Grünenthal”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson
Pharmaceutical Research and Development LLC (“J&JPRD”)
dated December 29, 2006 (“Main Agreement”)

 

[***](26)

 


(26) Two pages omitted and filed separately with the Commission.

 

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

 



 

GRÜNENTHAL GMBH

 

Side Letter No. 17 to the Amended and Restated License Agreement (the “Agreement”) between
Grünenthal GmbH (“Grünenthal”), Ortho-McNeil-Janssen Pharmaceuticals, Inc. (successor in interest
to Ortho-McNeil Pharmaceuticals, Inc. (“Ortho”)), Johnson & Johnson Pharmaceutical Research and
Development LLC, (“J&J PRD”) (Ortho and J&J PRD hereinafter collectively (“OMP”), and as guarantor

according to Article 19.1 of the Agreement Johnson & Johnson (“Johnson & Johnson”), dated
December 29, 2006.  Grünenthal and OMP may be referred to individually herein as a “Party” or
together as the “Parties”.

[***](27)

 


(27) Six pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 18 to the Amended and Restated License Agreement dated December 29, 2006
(“the Main Agreement”) between Grünenthal GmbH (“Grünenthal”), and Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (successor in interest to Ortho-McNeil Pharmaceuticals, Inc. (“Ortho”)), Johnson
& Johnson Pharmaceutical Research and Development LLC, (“J&JPRD”) (Ortho and J&J PRD hereafter

collectively (“OMP”), and as guarantor according to Article 19.1 of the Agreement Johnson & Johnson

(“Johnson & Johnson”).  Grünenthal and OMP may be referred to individually herein as a “Party” or
together as the “Parties”.

 

[***](28)

 


(28) Two pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 19 to the Amended and Restated License Agreement dated December 29, 2006
(“Main Agreement”) between Grünenthal GmbH (“Grünenthal”), and Ortho-McNeil-Janssen

Pharmaceuticals, Inc. (successor in interest to Ortho-McNeil Pharmaceuticals, Inc. (“Ortho”)), Johnson

& Johnson Pharmaceutical Research and Development LLC, (“J&JPRD”) (Ortho and J&J PRD hereafter

collectively (“OMP”), and as guarantor according to Article 19.1 of the Agreement Johnson & Johnson

(“Johnson & Johnson”).  Grünenthal and OMP may be referred to individually herein as a “Party” or

together as the “Parties”.

[***](29)

 


(29) Three pages omitted and filed separately with the Commission.

 

 

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

 



 

Side Letter No. 20 to the Amended and Restated License Agreement dated December 29, 2006
(“Main Agreement”) between Grünenthal GmbH (“Grünenthal”), and Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (successor in interest to Ortho-McNeil Pharmaceuticals, Inc. (“Ortho”)), Johnson

& Johnson Pharmaceutical Research and Development LLC, (“J&JPRD”) (Ortho and J&J PRD hereafter

collectively (“OMP”), and as guarantor according to Article 19.1 of the Agreement Johnson & Johnson

(“Johnson & Johnson”).  Grünenthal and OMP may be referred to individually herein as a “Party” or

together as the “Parties”.

 

[***](30)

 


(30) Two pages omitted and filed separately with the Commission.

 

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

 



 

Amended Side Letter No. 21 to the Amended and Restated License Agreement between Grünenthal

GmbH (“GRT”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson Pharmaceutical Research

and Development LLC (“J&JPRD”) dated December 29, 2006 (“Main Agreement”)

[***](31)

 


(31) Twelve pages omitted and filed separately with the Commission.

 

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

 



 

Side Letter No. 21 to the Amended and Restated License Agreement between
Grünenthal GmbH (“GRT”) and Ortho-McNeil Pharmaceutical, Inc. / Johnson & Johnson

Pharmaceutical Research and Development LLC (“J&JPRD”) dated December 29, 2006 (“Main

Agreement”)

 

[***](32)

 


(32) Five pages omitted and filed separately with the Commission.

 

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

 


Exhibit 10.4

 

CERTAIN MATERIAL (INDICATED BY [***] ) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

TRANSITIONAL SUPPLY AGREEMENT

 

between

 

Janssen Ortho LLC,

 

Janssen Pharmaceuticals, Inc.

 

and

 

Depomed, Inc.

 

DATED AS OF April 2, 2015

 

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

 



 

THIS TRANSITIONAL SUPPLY AGREEMENT (this “ Supply Agreement ”) is made as of April 2, 2015 (the “ Effective Date ”) by and among Janssen Ortho LLC, a Delaware limited liability company located at Bo. Mamey, Carr. 933 Km 0., Gurabo, Puerto Rico 00778-9629, United States, Janssen Pharmaceuticals, Inc. (individually referred to as “ Seller ” and, together with Janssen Ortho LLC, “ Manufacturer ”), a Pennsylvania corporation located at 1125 Trenton-Harbourton Road, Titusville, NJ 08560 and Depomed, Inc. (the “ Purchaser ”), a California corporation located at 7999 Gateway Boulevard, Suite 300, Newark, CA 94560.  Manufacturer and Purchaser are individually referred to as a “ Party ” and collectively as the “ Parties ,” as the context may require.

 

RECITALS

 

WHEREAS:

 

(A)        Seller, an Affiliate of Janssen Ortho LLC, and Purchaser are parties to that certain Asset Purchase Agreement, dated as of January 15, 2015 (the “ Asset Purchase Agreement ”), pursuant to which, among other things, Seller agreed to sell, and Purchaser agreed to purchase, certain rights and assets related to the products containing the active pharmaceutical ingredient tapentadol as set forth in Appendix A (the “ Products ”), and Purchaser agreed to assume certain liabilities related to the Products, in the United States;

 

(B)        Pursuant to Section 6.07 of the Asset Purchase Agreement, Purchaser and Seller (or its Affiliate) agreed to enter into a transitional supply agreement, on the terms set forth in Exhibit D to the Asset Purchase Agreement, pursuant to which Seller (or its Affiliate) will manufacture and supply Purchaser’s requirements of Products for distribution and sale in the United States until Purchaser has sufficient capacity and capability to manufacture Purchaser’s requirements of Products for distribution in the United States and Seller’s (and its Affiliates’) requirements of products containing the active pharmaceutical ingredient tapentadol for distribution outside the United States (such products, the “ Seller Products ”); and

 

(C)        Purchaser wishes to purchase Products, and Manufacturer is willing to supply Products to Purchaser, on the terms and conditions of this Supply Agreement.

 

NOW IT IS AGREED AS FOLLOWS:

 

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

 

2



 

DEFINITIONS

 

All capitalized terms not otherwise defined in this Supply Agreement shall have the same definition as set forth in the Asset Purchase Agreement. As used throughout this Supply Agreement, each of the following terms shall have the respective meaning set forth below (and plural forms of singular and vice-versa and other variants thereof shall have correlative meanings). In the event of a conflict between the terms of this Supply Agreement and the terms of the Asset Purchase Agreements, the terms of this Supply Agreement shall prevail:

 

API

 

shall mean the active pharmaceutical ingredient tapentadol.

 

 

 

API Supply Agreement

 

shall mean that certain Supply Agreement by and between Noramco, Inc. and Purchaser, dated as of the Effective Date, pursuant to which Noramco. Inc. has agreed to supply API to Purchaser.

 

 

 

Applicable Law

 

shall mean all applicable laws, rules, regulations, guidelines or other requirements of governmental authorities, including those that may be in effect from time to time in the United States or Seller Countries with respect to the validity or enforceability of this Supply Agreement or activities under this Supply Agreement, as may be applicable.

 

 

 

Asset Purchase Agreement

 

shall have the meaning as set forth in the recitals to this Supply Agreement.

 

 

 

BDP or Bulk Drug Products

 

shall mean bulk Product(s) with or without its primary packaging as described and defined in the documentation and Specifications.

 

 

 

BDS or Bulk Drug Substance

 

shall mean bulk API as described and defined in the documentation and Specifications.

 

 

 

Binding Period

 

shall have the meaning set forth in Section 3.2(b).

 

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

 

3



 

Breaching Party

 

shall have the meaning set forth in Section 7.1.

 

 

 

Certificate of Analysis

 

shall have the meaning set forth in the Quality Agreement.

 

 

 

Certificate of Conformance

 

shall have the meaning set forth in the Quality Agreement.

 

 

 

cGMP or “ GMP

 

shall mean current good manufacturing practices as required by the rules and regulations of the FDA or any other Regulatory Authority outside the United States, as applicable to the manufacturing, packaging, handling, storage and control of API or Products.

 

 

 

Claim

 

shall have the meaning set forth in Section 17.3.

 

 

 

Corrective Action

 

shall have the meaning set forth in Section 10.4.

 

 

 

Damages

 

shall mean any and all damages, liabilities, claims, costs, charges, judgments, injuries, awards, fines, penalties, fees and expenses (including reasonable attorneys’ fees) suffered or incurred.

 

 

 

Days of Coverage

 

shall mean [***]

 

 

 

DEA

 

shall mean the Drug Enforcement Administration of the United States Department of Justice or any successor organization.

 

 

 

DEA Aggregate Production Quota

 

shall mean the national limit set by the DEA on the amount of tapentadol which may be produced in a given calendar year .

 

 

 

DEA Manufacturing Quota

 

shall mean the amount of tapentadol that Manufacturer or its Affiliates may produce in a given calendar year, which amount is set by the DEA and must be equal to or

 

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

 

4



 

 

 

less than the DEA Aggregate Production Quota, provided that the Parties acknowledge that the DEA aligns the grant based on API supplier information given by Manufacturer and/or Purchaser, as the case may be.

 

 

 

DEA Procurement Quota

 

shall mean the quota issued by the DEA to Manufacturer (and/or Purchaser’s CMO) for the purchase of API and formulation of such API into Product in a given calendar year, which includes factor-in sales, manufacturing losses, allowable inventory and exports and applies to movement between Manufacturer’s manufacturing sites, between Manufacturer and Purchaser’s CMO and customer returns.

 

 

 

Default Interest Amount

 

shall mean the prime rate of interest quoted in The Wall Street Journal on the first business day of the month during which an amount becomes overdue under this Supply Agreement, plus [***] calculated on an annual basis.

 

 

 

Defective Product

 

shall mean any Product that, upon Delivery, is not (i) in compliance with the Specifications for such Product, (ii) in compliance with cGMP or GMP, (iii) is adulterated or misbranded, (iv) in compliance with all applicable Laws or (v) in compliance with any Regulatory Approvals applicable to such Product.

 

 

 

Delivery

 

shall have the meaning set forth in Section 8.1(c).

 

 

 

Discretionary Changes

 

shall have the meaning set forth in Section 5.3.

 

 

 

Distribution

 

shall mean, with respect to the United States and, as may by applicable, the Seller Countries, importing, selling, distributing, exporting, transporting and other activities associated with the foregoing listed activities with

 

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

 

5



 

 

 

respect to the distribution of a product, including inventory management and control, warehousing and distribution, invoicing, collection of sales proceeds, preparation of sales records and reports, customer relations and services, and the handling of returns.

 

 

 

Effective Date

 

shall have the meaning set forth in the preamble to this Supply Agreement.

 

 

 

ER Line 1

 

shall mean the manufacturing equipment related to the ER Products (as defined below) set forth on Appendix B attached hereto .

 

 

 

ER Line 2

 

shall mean the manufacturing equipment related to the ER Products (as defined below) set forth on Appendix C attached hereto .

 

 

 

ER Product

 

shall mean any Product that is identified as “extended release” or “ER” on Appendix A .

 

 

 

FDA

 

shall mean the United States Food and Drug Administration, and any successor organization having substantially the same functions.

 

 

 

Force Majeure Event

 

shall have the meaning set forth in Section 11.1.

 

 

 

Forecast

 

shall mean the Initial Forecast and/or the Rolling Forecast, as applicable.

 

 

 

Good Distribution Practice or GDP

 

shall mean the then-current standards for Distribution activities as set forth by the World Health Organization and Applicable Law, as amended from time to time.

 

 

 

Hidden Defect

 

shall mean a defect in a Product which cannot reasonably be detected, either upon Delivery or upon first receipt by Purchaser, by means of a customary visual inspection of the shipment (without opening

 

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

 

6



 

 

 

secondary packaging) or by consulting the Certificate of Analysis accompanying such Product .

 

 

 

Indemnified Party

 

shall have the meaning set forth in Section 17.3.

 

 

 

Indemnifying Party

 

shall have the meaning set forth in Section 17.3.

 

 

 

Initial Forecast

 

shall have the meaning set forth in Section 3.1.

 

 

 

Initial Price Term

 

shall have the meaning set forth in Section 2.1.

 

 

 

Inventory

 

shall mean the stock of Raw Materials, BDS, BDP, work-in-progress, and/or Products in the possession of Manufacturer and/or its Affiliates.

 

 

 

IR Product

 

shall mean any Product that is not an ER Product.

 

 

 

Mandatory Changes

 

shall have the meaning set forth in Section 5.2.

 

 

 

Manufacturer

 

shall have the meaning as set forth in the preamble to this Supply Agreement.

 

 

 

Manufacturer Indemnified Parties

 

shall have the meaning set forth in Section 17.1.

 

 

 

Manufacturer’s Facility

 

shall mean Manufacturer’s facility located at Gurabo, Puerto Rico.

 

 

 

Manufacturer’s Image

 

shall mean the label and packaging for each Product incorporating Manufacturer’s NDC, name, trademarks, logos and trade dress.

 

 

 

Minimum Order Quantity

 

shall have the meaning set forth in Section 3.4.

 

 

 

NDC

 

shall have the meaning set forth in Section 1.2.

 

 

 

Non-Binding Period

 

shall have the meaning set forth in Section 3.2(b).

 

 

 

Party/Parties

 

shall have the meaning as set forth in the preamble to

 

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

 

7



 

 

 

this Supply Agreement.

 

 

 

Post-Transfer Supply Agreement

 

shall have the meaning set forth in Section 4.3.

 

 

 

Products or Product

 

shall have the meaning set forth in the recitals to this Supply Agreement.

 

 

 

Purchase Order

 

shall have the meaning set forth in Section 3.3(b).

 

 

 

Purchaser

 

shall have the meaning as set forth in the preamble to this Supply Agreement.

 

 

 

Purchaser Indemnified Parties

 

shall have the meaning set forth in Section 17.2.

 

 

 

Purchaser’s Image

 

shall mean the label and packaging for each Product , which shall be identical to Manufacturer’s Image for such Product, except that Manufacturer’s NDC, name, trademarks, logos and trade dress shall be replaced with Purchaser’s NDC, name, trademarks, logos and trade dress.

 

 

 

Purchaser’s Facility

 

shall have the meaning set forth in Section 4.1(b).

 

 

 

Quality Agreement

 

shall have the meaning set forth in Section 10.1.

 

 

 

Quarter

 

shall have the meaning set forth in Section 3.2(b).

 

 

 

Raw Materials

 

shall mean the materials, components and packaging materials required to manufacture and/or package the Products in accordance with the Specifications.

 

 

 

Regulatory Approval

 

shall mean, with respect to any country or regulatory jurisdiction, any and all approvals from any Regulatory Authority in such country or regulatory jurisdiction which are necessary for the manufacture, packaging, shipment, storage, importation, marketing, use, distribution and sale of a

 

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

 

8



 

 

 

pharmaceutical product in such country or jurisdiction.

 

 

 

Regulatory Authority

 

shall mean all governmental agencies or authorities regulating the manufacture, packaging, sale, shipment or storage of the Products, including the FDA.

 

 

 

Rolling Forecast

 

shall have the meaning set forth in Section 3.2(a).

 

 

 

Scale-Up Period

 

shall mean, separately for the ER Products and the IR Products, as applicable, the period beginning on the day after the last day of the Transition Period and ending on the later of date on which the Parties mutually agree that Purchaser shall assume responsibility for the manufacture of Purchaser’s requirements of ER Products or IR Products, as applicable, for Distribution in the United States and Seller’s requirements of extended release Seller Products or immediate release Seller Products, as applicable, for Distribution in the Seller Countries.

 

 

 

Seller

 

shall have the meaning as set forth in the recitals to this Supply Agreement.

 

 

 

Seller Countries

 

shall mean all of the countries set forth on Appendix D attached hereto, which may be amended by Manufacturer at any time during the Term upon written notice to Purchaser, provided that (i) manufacturing capacity for any new country is available and (ii) the addition of any new country shall not impose any additional material regulatory or legal requirement on Purchaser or Purchaser’s Facility.

 

 

 

Seller Products

 

shall have the meaning as set forth in the recitals to this Supply Agreement.

 

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

 

9



 

Semi-Binding Period

 

shall have the meaning set forth in Section 3.2(b).

 

 

 

Specifications

 

shall mean the specifications for each Product and the Raw Materials, including the specifications for the design, composition, product safety assurance, manufacture, packaging and quality control of the Products and the Raw Materials, as set forth in NDA No. 022304 and NDA No. 200533 (and as may be modified thereafter by mutual agreement in accordance with the Quality Agreement).

 

 

 

Supply Agreement

 

shall have the meaning as set forth in the preamble to this Supply Agreement.

 

 

 

Supply Prices

 

shall have the meaning set forth in Section 2.1.

 

 

 

Technology Transfer

 

shall have the meaning as set forth in Section 4.2(a).

 

 

 

Technology Transfer and Manufacturing

 

 

 

 

 

Transition Plan or TTMTP

 

shall have the meaning as set forth in Section 4.2(b).

 

 

 

Term

 

shall have the meaning set forth in Article 6.

 

 

 

Transition Period

 

shall mean, separately for the ER Products and the IR Products, as applicable, the period beginning on the Effective Date and ending on the date that Purchaser notifies Manufacturer in writing that it has received Regulatory Approval to manufacture, at Purchaser’s Facility, the ER Products or IR Products, as applicable, for Distribution in the United States.

 

 

 

Transition Plan

 

shall mean the Transition Plan prepared by Purchaser and Seller in accordance with Section 6.33 of the Asset Purchase Agreement.

 

 

 

Visible Defect

 

shall mean a defect in a Product which can or should

 

 

 

 

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

 

10



 

 

 

reasonably be detected, either upon Delivery or upon first receipt by Purchaser, by means of a customary visual inspection of the shipment (without opening secondary packaging) or by consulting the Certificate of Analysis accompanying such Product.

 

1.                                       Supply of Products

 

1.1                                General .

 

(a)                                  Subject to the terms and conditions of this Supply Agreement, during the Transition Period, Manufacturer shall manufacture, package and supply Purchaser with, and Purchaser shall purchase from Manufacturer, [***] of Purchaser’s requirements of Products in Manufacturer’s Image or in Purchaser’s Image, as applicable in accordance with Sections 1.1(c) and 1.2, for Distribution in the United States.

 

(b)                                  Subject to the terms and conditions of this Supply Agreement, during the Scale-Up Period, Manufacturer shall manufacture, package and supply Purchaser with, and Purchaser shall purchase from Manufacturer, those quantities of Products ordered by Purchaser for Distribution in the United States.

 

(c)                                   All Products provided under this Section 1.1 shall be in Purchaser’s Image; provided , however , that Products shall be in Manufacturer’s Image until (i) Purchaser notifies the FDA of a label change for each of the Products in accordance with Section 1.2 and such label change has become effective and, if approval were required, approved,  and (ii) released packaging materials with Purchaser’s Image are available at Manufacturer’s Facility.

 

(d)                                  The Parties acknowledge that Purchaser will not be obligated to buy any specific amounts of Products under this Supply Agreement, except for the quantities timely produced and as indicated in the Binding Period.  The Parties further acknowledge that Purchaser’s right to purchase, and Manufacturer’s obligation to supply, Products shall not commence unless and until the Parties fulfill their obligations under Section 6.08(a) of the Asset Purchase Agreement to execute and deliver to the FDA the Seller FDA Transfer Letters and the Purchaser FDA Transfer Letters.

 

1.2                                Change of Label .  As soon as possible following the Effective Date, Purchaser shall, with

 

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

 

11



 

respect to each Product, apply for and obtain a new National Drug Code (“ NDC ”) and notify the FDA that the label for such Product will be changed to Purchaser’s Image, in each case, in accordance with the Transition Plan.

 

1.3                                Stability Studies .  Manufacturer will perform stability studies with respect to Products manufactured at Manufacturer’s Facility required for the United States until analytical methods are transferred to Purchaser and Purchaser has received approval for its testing facility, with such stability studies to be at a cost to be mutually agreed by the Parties.  After approval of Purchaser’s testing facility, Purchaser and Manufacturer will agree on the testing site for on-going stability studies of Products manufactured at Manufacturer’s Facility, and Purchaser will be responsible for initiation of any new stability studies required for Products manufactured at Manufacturer’s Facility for Distribution in the United States.

 

1.4                                Regulatory Approvals .  As of the Effective Date and throughout the Term, Manufacturer has and will have all permits, establishment and facility licenses required by Regulatory Authorities that are necessary for Manufacturer to manufacture, store and test the Products at Manufacturer’s Facility and provide Products to Purchaser in accordance with the terms of this Supply Agreement. In the event of any Discretionary Change that has been requested by Purchaser and subsequently accepted by Manufacturer or any Mandatory Change that is not required for, or applicable to, any other product which Manufacturer manufactures in Manufacturer’s Facility, Manufacturer will be responsible for securing any Regulatory Approvals that are necessary to implement such change, all at Purchaser’s expense.

 

2.                                       Supply Prices for Products

 

2.1                                Supply Prices during Initial Price Term .  The initial prices for each Product ordered by Purchaser in accordance with the terms of this Supply Agreement during the period beginning on the Effective Date and ending [***] (the “ Initial Price Term ”) are set forth in Appendix E (the “ Supply Prices ”).

 

2.2                                Supply Prices after Initial Price Term .  After the Initial Price Term, a reasonable increase in the Supply Prices shall be mutually agreed upon by the Parties [***] ; provided , however , that the initial increase in the Supply Prices shall be mutually agreed upon by the Parties by no later than [***] prior to the end of the Initial Price Term and shall apply for the remainder of the calendar year during which the Initial Price Term ends.  In the event the Parties do not mutually agree upon an increase in the Supply

 

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

 

12



 

Prices by the deadlines set forth in the immediately preceding sentence, then the Supply Prices shall be [***].

 

2.3                                Supply Price Adjustments to Reflect Costs .  In addition to the Supply Price increases set forth in Section 2.2, Manufacturer shall be entitled to adjust Supply Prices for Products to reflect any significant increases [***] in the aggregate costs of the Raw Materials, or fees of any third party contractor incurred by Manufacturer, as compared to the then-current costs or fees, and after good faith discussion with Purchaser. Such Supply Price increases shall be applicable to any and all orders placed more than [***] after Manufacturer has notified Purchaser in writing of (a) the increase in costs or fees and (b) the increased Supply Prices for the Products that reflect such increase in costs or fees. Purchaser shall be entitled to request that an independent certified accountant verify the accuracy of any such increases and adjustments to the Supply Price.

 

2.4                                Samples .  No free goods, such as analytical standards, Product samples, promotional Products or promotional materials, shall be provided by Manufacturer to Purchaser or to any Regulatory Authority, except that Manufacturer shall not unreasonably refuse to provide reasonable quantities of free goods for Purchaser’s technology transfer purposes.

 

2.5                                Payment Terms .  Purchaser shall pay all undisputed invoices within [***] end of month after receipt of such invoice for the order, provided that the relevant Certificate of Analysis, Certificate of Conformance and all other appropriate transport related documentation have been provided to Purchaser.  Such invoice shall be sent at the time of delivery of such Products to Purchaser or its Affiliate in accordance with Section 8.1.  All payments made hereunder shall be in U.S. Dollars.  Any payments not made within the specified period of time for payment shall incur an interest charge at the rate of the Default Interest Amount on such overdue amounts, excluding any amounts that are subject to a bona fide dispute between the Parties.  In addition, Manufacturer may withhold delivery of Products if Purchaser fails to make any payment required under this Supply Agreement (except for any amounts that are subject to a bona fide dispute) [***] days after the due date for such payment. Manufacturer will accept payment by wire transfer, provided that any wire transfer will include a reference to Manufacturer’s sales invoice number.

 

3.                                       Forecasts; Orders

 

3.1                                Initial Forecast for Products .  Prior to the Effective Date, Manufacturer provided

 

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

 

13



 

Purchaser with Seller’s forecast of finished Product for Distribution in the United States during the [***] period beginning on the Effective Date, including the Product packaging schedule based on existing purchase orders (the “ Initial Forecast ”).  The first (1 st ) [***] of the Initial Forecast shall be binding on Purchaser, meaning that Purchaser shall purchase all quantities of stock keeping units produced in accordance with such Initial Forecast as reasonably required for the forecasted quantities of Products for such [***] period.  Within [***] after the Effective Date, Purchaser shall provide Manufacturer with an updated Initial Forecast and Manufacturer shall use commercially reasonable efforts to meet such updated Initial Forecast; provided, however, no changes shall be made to the first [***] of the Initial Forecast.

 

3.2                                Updated Rolling Forecast for Products .

 

(a)                                  Beginning [***] , Purchaser shall provide to Manufacturer, no later than [***] , an updated forecast of its requirements of Products for Distribution in the United States during the following [***] period (the “ Rolling Forecast ”) starting with the month following the month during which such Rolling Forecast was provided.

 

(b)                                  The Rolling Forecast shall be divided in [***] consecutive three (3) month periods (each, a “ Quarter ”) starting with the month following the month during which such Rolling Forecast was provided.  The [***] of the Rolling Forecast shall be binding (the “ Binding Period ”).  The forecast for the Binding Period shall be provided in monthly quantities of number of packs of stock keeping units.  The [***] Quarters of the Rolling Forecast shall be semi-binding (the “ Semi-Binding Period ”), meaning that, in the next Rolling Forecast, Purchaser may increase or decrease the quantities forecasted [***]  Manufacturer shall use commercially reasonable efforts to plan the manufacture of Products to meet Purchaser’s forecast for the Semi-Binding Period.  The forecast for the Semi-Binding Period shall be provided in monthly quantities of number of packs of stock keeping units .  The [***] Quarters of the Rolling Forecast are considered to be non-binding (the “ Non-Binding Period ”).  The forecast for the Non-Binding Period shall be provided in quarterly quantities of number of packs of specific stock keeping units .  The Parties acknowledge and agree that Manufacturer’s application to the DEA for DEA Procurement Quota for each calendar year will be based on Purchaser’s Forecast for Products for distribution in the United States for such calendar year and Seller’s (and its Affiliates’) forecasts for Seller Products for distribution outside the United States for such calendar year.  Promptly after the DEA grants a DEA Procurement Quota to Manufacturer for any calendar year, Manufacturer will allocate such DEA Procurement Quota between Purchaser and Seller (and its Affiliates) in proportion to the forecasts used to prepare the application for such DEA Procurement Quota, and will notify Purchaser of the portion of such

 

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

 

14



 

DEA Procurement Quota allocated to Purchaser (such portion, the “ Purchaser DEA Procurement Quota ”).  Notwithstanding anything to this contrary in this Section 3.2, the quantities set forth in the Rolling Forecast shall not exceed the Purchaser DEA Procurement Quota for the applicable calendar year.  If, after Manufacturer notifies Purchaser of the Purchaser DEA Procurement Quota for any calendar year, Purchaser demonstrates that an increase to such Purchaser DEA Procurement Quota is warranted by demand, Manufacturer will cooperate with Purchaser to apply to the DEA for an increase to the DEA Procurement Quota for such calendar year and, if necessary to satisfy the requested increase to the DEA Procurement Quota, an increase to the DEA Manufacturing Quota granted to Noramco for such calendar year and an increase to the DEA Aggregate Production Quota for such calendar year.  Any requested increases to the DEA Procurement Quota, DEA Manufacturing Quota and DEA Aggregate Production Quota shall be subject to the approval of the DEA and shall be sought in accordance with DEA regulations, rules and procedures.  If the DEA approves an increase to the DEA Procurement Quota (and any corresponding increase to the DEA Manufacturing Quota and DEA Aggregate Production Quota) sought in accordance with this Section 3.2(b), then: (i) the approved increase to the DEA Procurement Quota shall be added to the Purchaser DEA Procurement Quota for the applicable calendar year, (ii) Manufacturer may initiate the additional manufacture of Product (and, if necessary, request that Noramco initiate the manufacture of, or supply, the additional API needed for such additional Product) to satisfy the increase in the Purchaser DEA Procurement Quota, and (iii) Purchaser may update the Rolling Forecast to reflect the increased Purchaser DEA Procurement Quota.  For the sake of clarity, in no event shall Manufacturer be required to apply any portion of the DEA Procurement Quota to the manufacture of Products for Purchaser other than the Purchaser DEA Procurement Quota.

 

(c)                                   During the period prior to the effective date of the label change contemplated by Section 1.1(c), Purchaser and Manufacturer shall cooperate to minimize the number of Products packaged in Manufacturer’s trade dress and to maximize the number of Products packaged in Purchaser’s trade dress, which may include, without limitation, reasonable changes to existing Purchase Orders, the Binding Periods and Semi-Binding Periods and Purchase Orders with quantities below the Minimum Order Quantity.

 

3.3                                Purchase Orders for Products .

 

(a)                                  On the Effective Date, Purchaser agrees to accept and be bound by existing purchase orders covering the currently effective Binding Period for Products not yet manufactured and for Distribution in the United States submitted by Seller and present in Manufacturer’s purchase order

 

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

 

15



 

system.

 

(b)                                  Purchaser shall deliver to Manufacturer, together with each Rolling Forecast, but in any event no later than [***] prior to the requested delivery date, a written purchase order for the Products during the months covered by the Binding Period of such Rolling Forecast (each, a “ Purchase Order ”).  Purchaser shall issue a Purchase Order by written or electronic means (or by any other means agreed to by the Parties), stating (i) the quantity of each of the Products ordered and (ii) the desired date of delivery.

 

3.4                                Minimum Order Quantities .  Manufacturer shall not be obligated to accept Purchase Orders for quantities of any Product that are less than the “ Minimum Order Quantity ” for such Product set forth in the table below; provided , however , Manufacturer will reasonably consider accepting such Purchase Orders submitted prior to the effective date of the label change pursuant to Section 1.1(c), as outlined in Section 3.2(c).

 

Janssen Material
Number

 

Janssen Material Description

 

Minimum Order Quantity

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

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

 

16



 

3.5                                Order Confirmation and Rejection .  Manufacturer shall confirm, reject or otherwise respond to Purchaser within [***] after receipt of any Purchase Order.  Manufacturer shall not unreasonably refuse any Purchase Order and, except as expressly provided herein, Manufacturer shall timely provide Purchaser with the required quantities of Products as indicated in a confirmed Purchase Order.  Notwithstanding the foregoing, Manufacturer shall have the right to reject any Purchase Order for quantities of Products that are different from the quantities as forecasted by Purchaser in the Binding Period of the Forecast.

 

3.6                                Order Cancellation .  If Purchaser cancels a Purchase Order, or any part thereof, [***] or less prior to Manufacturer’s planned packaging date of the Products covered by such Purchase Order, then Manufacturer shall use commercially reasonable efforts to utilize, for other manufacturing and packaging activities, the manufacturing and packaging capacities in Manufacturer’s Facility that would have been used to manufacture and package the amounts of Products covered by such Purchase Order, or part thereof, that was cancelled. If Manufacturer, in spite of using commercially reasonable efforts, cannot utilize such manufacturing and packaging capacities, Manufacturer will charge Purchaser and Purchaser will pay a fee of [***] of the Supply Prices for the cancelled Products.

 

3.7                                Raw Materials .  Purchaser acknowledges and agrees that, in order for Manufacturer to meet its obligation to supply Products under this Supply Agreement, Manufacturer must order Raw Materials in accordance with defined lead times and any minimum order quantities imposed by third party vendors. Manufacturer shall be entitled to order, and shall maintain, quantities of Raw Materials required to manufacture those Products forecasted for the Binding Period so that Manufacturer will be able to comply with Purchaser’s delivery dates for Purchaser’s actual and anticipated orders of Products. Manufacturer shall be responsible for, and shall administer on a daily basis, the procurement of the Raw Materials in accordance with the terms herein.  Manufacturer’s responsibilities in connection with the purchasing and procurement of Raw Materials from the third party vendors in accordance with the terms of this Supply Agreement shall include: ordering, purchasing, transportation, reception, inspection, release and storage of Raw Materials.

 

3.8                                Reimbursement for Unused Raw Materials .  To the extent Manufacturer has purchased Raw Materials in accordance with Section 3.7, but subsequent to such purchase and prior to the

 

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

 

17



 

conversion of any Raw Materials into Products, Purchaser either cancels a Purchase Order or does not issue a Purchase Order in accordance with the Binding Period of a Rolling Forecast or informs Manufacturer that it no longer desires to have Manufacturer use such Raw Materials in any Products, Manufacturer shall first use good faith efforts to return such Raw Materials to applicable third party vendors and receive a credit for such purchase.  If the third party vendor refuses to accept such Raw Materials and provide Manufacturer with a credit, then Manufacturer shall invoice Purchaser for the cost of such Raw Materials within [***] of Purchaser cancelling a Purchase Order or not issuing a Purchase Order in accordance with the Binding Period of a Rolling Forecast or informing Manufacturer that it no longer desires to have Manufacturer use such Raw Materials in any Products and Purchaser shall pay such invoice within [***] after receipt. After receipt of payment for such Raw Materials, Manufacturer shall either ship or destroy such Raw Materials, as directed by Purchaser.  Purchaser shall reimburse Manufacturer for all reasonable and documented costs and expenses relating to the shipment or destruction of such Raw Materials.

 

3.9                                Conflicts .  To the extent of any conflict or inconsistency between this Supply Agreement and any Purchase Order, purchase order release, confirmation, acceptance or any similar document, the terms of this Supply Agreement shall govern.

 

4.                                       Transfer of Manufacturing Equipment; Technology Transfer and Manufacturing Transition

 

4.1                                Transfer of Manufacturing Equipment .

 

(a)                                  Pursuant to the Asset Purchase Agreement, title and risk of loss/damage with respect to ER Line 1 and ER Line 2 shall pass to Purchaser on the Effective Date.

 

(b)                                  Promptly following the Effective Date, Manufacturer shall dismantle and ship ER Line 2 to Purchaser’s designated facility (“ Purchaser’s Facility ”).  Manufacturer and Purchaser shall each bear its own internal costs incurred in dismantling and shipping ER Line 2 to Purchaser’s Facility, and Purchaser shall reimburse Manufacturer for all reasonable and documented out-of-pocket expenses in dismantling and shipping ER Line 2 to Purchaser’s Facility, including the costs of physically transporting ER Line 2 from Manufacturer’s Facility to Purchaser’s Facility.

 

(c)                                   During the Transition Period and Scale-Up Period, ER Line 1 shall remain at

 

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

 

18



 

Manufacturer’s Facility, and Purchaser hereby grants Manufacturer the right to use ER Line 1 to manufacture ER Products.  ER LINE 1 IS BEING USED BY MANUFACTURER “AS IS” WITH ALL FAULTS AND WITHOUT WARRANTY OF ANY KIND BY PURCHASER.  Manufacturer shall, at Manufacturer’s sole cost and expense, conduct all regularly scheduled maintenance and performance qualifications as currently performed in the normal course of business, and provide replacement parts necessary to maintain ER Line 1 in good working condition and in good repair, which replacement parts shall become part of ER Line 1.

 

(d)                                  Promptly following the end of the Scale-Up Period, Manufacturer shall dismantle and ship ER Line 1 to Purchaser’s Facility.  Manufacturer and Purchaser shall each bear its own internal costs incurred in dismantling and shipping ER Line 1 to Purchaser’s Facility and Purchaser shall reimburse Manufacturer for all reasonable and documented out-of-pocket expenses incurred by Purchaser in dismantling and shipping ER Line 1 to Purchaser’s Facility.

 

4.2                                Technology Transfer and Manufacturing Transition .

 

(a)                                  Technology Transfer.  Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to Purchaser’s Facility (the “ Technology Transfer ”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities:

 

(i)                                      Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2;

 

(ii)                                   Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date;

 

(iii)                                Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products;

 

(iv)                               Manufacturer’s provision of a forecast of Seller’s and its

 

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

 

19



 

Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term;

 

(v)                                  Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License;

 

(vi)                               if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA;

 

(vii)                            Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement;

 

(viii)                         Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided , however , if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost ; provided further , however , that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an

 

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

 

20



 

appropriate allocation of the costs of such activity ;

 

(ix)                               following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility;

 

(x)                                  following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility;

 

(xi)                               on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country;

 

(xii)                            the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and

 

(xiii)                         Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided , however , if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost ; provided further , however , that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the

 

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

 

21



 

costs of such activity .

 

(b)                                  Technology Transfer and Manufacturing Transition Plan.  The Technology Transfer will be conducted in accordance with a plan to be mutually agreed upon by the Parties within the later to occur of [***] following the Effective Date or [***] after the designation of Purchaser’s Facility by Purchaser and attached hereto as Appendix F (the “ Technology Transfer and Manufacturing Transition Plan ” or “ TTMTP ”).  In developing the TTMTP, the Parties shall seek to minimize costs and expenses associated with the Technology Transfer.  The TTMTP may be amended during the Term upon mutual written agreement of Manufacturer and Purchaser.  Purchaser will lead and is responsible for the completion of the Technology Transfer.  Purchaser will ensure that sufficient resources are allocated to successfully execute the TTMTP .  Manufacturer will perform the tasks assigned to Manufacturer in the TTMTP and will provide reasonable support to Purchaser in the performance of the tasks assigned to Purchaser in the TTMTP The TTMTP will take into account that Manufacturer’s reasonable support shall be limited to the following activities:

 

(i)                                      providing clarification and explanation on the manufacturing know-how and technical information relating to the Products in writing, by teleconference and meetings, which will be held [***];

 

(ii)                                   at Purchaser’s reasonable request, reviewing protocols for the transfer of the analytical methods and manufacturing processes with respect to the Products;

 

(iii)                                providing in-person assistance or witnessing of the implementation of critical technical processes (including transfer of analytical methods) with respect to the manufacture of Products;

 

(iv)                               causing appropriate employees and, to the extent practicable, other representatives of Manufacturer to meet with employees of Purchaser or its designee, at Purchaser’s Facility, to assist with the working up and use of the manufacturing process to the extent reasonably necessary to enable Purchaser to manufacture Products in accordance with the Specifications on a commercial scale, provided that there shall be no more than [***] such meetings with respect to the IR Products and [***] such meetings with respect to the ER Products during the first [***] of the Term;

 

(v)                                  providing documentation or advice as are reasonably necessary

 

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

 

22



 

to assist Purchaser in obtaining any Regulatory Approval with respect to Purchaser’s manufacture of Products, but only to the extent that such documentation is pre-existing or can be easily obtained or gathered by Manufacturer; and

 

(vi)                               providing expert advice in case of unexpected results during the Technology Transfer.

 

(c)                                   Costs of Technology Transfer .  Purchaser shall be responsible for all costs of performing the Technology Transfer, except that Manufacturer shall be responsible for the costs of performing the tasks assigned to Manufacturer in the TTMTP and the costs of any activities that are solely related to the manufacture of Seller Products for Distribution in the Seller Countries (including registration, qualification and validation expenses and stability and bioequivalence studies that support only or substantially the Seller Countries); provided , however , that the Parties shall agree upon an appropriate allocation of the costs of any activities that are substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and are also required for the manufacture of Products for Distribution in the United States .

 

(d)                                  Bioequivalence Studies .  Notwithstanding anything to the contrary in this Supply Agreement, the Parties shall seek to develop a protocol for a single bioequivalence study that satisfies the regulatory requirements in all countries for which such studies are necessary (or as many countries as possible) and shall agree upon an appropriate allocation of the costs thereof between Manufacturer and Purchaser, which protocol and allocation shall be reflected in the TTMTP .  If any bioequivalence study that is necessary to obtain Regulatory Approval in any of the Seller Countries cannot be reasonably combined as described in the foregoing sentence, then Manufacturer shall be responsible for performing such bioequivalence study at its own expense.

 

(e)                                   Additional Activities performed by Manufacturer .  Any technical or other support services with respect to the Technology Transfer not explicitly described in the TTMTP shall be considered as additional activities, which shall be performed at Manufacturer’s sole discretion.  Purchaser shall reimburse Manufacturer for any reasonable and documented personnel costs and documented out-of-pocket expenses (e.g., travel and lodging) incurred by Manufacturer in performing any such additional activities.  The hourly rate for the personnel costs shall be [***] and shall be increased each year thereafter by [***].  Such additional activities will require prior written approval by Purchaser.  For the avoidance of doubt, Manufacturer shall have no obligation to assist Purchaser with respect to any

 

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

 

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proposed improvements or modifications to the manufacturing process of Products, except for adaptations required due to the Technology Transfer or changes initiated by Manufacturer.

 

(f)                                    Communication .  Purchaser shall, upon request of Manufacturer but at least twice per year during the Term, provide written updates to Manufacturer with respect to the status of the Technology Transfer, in such format as to be agreed between the Parties.

 

4.3                                Post-Transfer Supply Agreement .  Within [***] prior to the anticipated completion of the Technology Transfer for the ER Products or IR Products, whichever is sooner , Purchaser and Seller shall initiate negotiation of an agreement pursuant to which Purchaser shall manufacture up to [***] of Seller’s and its Affiliates’ (and its or their successors or assignees with respect to the Seller Products) requirements of Seller Products for Distribution in the Seller Countries (the “ Post-Transfer Supply Agreement ”).  No later than the day on which the process validation batches for the ER Products or IR Products are submitted to the appropriate Regulatory Authority in the first Seller Country, whichever is sooner , Purchaser and Seller shall execute the Post-Transfer Supply Agreement.  [***]  If requested by Seller, Purchaser shall execute separate Post-Transfer Supply Agreements with Seller or any its Affiliates (or any of its or their successors or assignees with respect to the Seller Products) for individual Seller Countries; provided , however , that the terms of any such Post-Transfer Supply Agreement shall be modified as necessary if a successor or assignee with respect to the Seller Products will be a party to any such Post-Transfer Supply Agreement and such successor or assignee will not supply API to Purchaser.

 

5.                                       Changes to Products

 

5.1                                Changes Generally .

 

(a)                                  Changes to Specifications and/or the manufacturing, testing and packaging process of the Products pursuant to this Section 5.1 shall be made in accordance with the Quality Agreement. Manufacturer and Purchaser shall cooperate in good faith to resolve any Product supply issues that may result from changes in the Specifications and/or the manufacturing, testing and packaging process of the Products. Each Party shall give the other Party reasonable written notice prior to any changes to the Specifications and/or the manufacturing and/or the packaging processes of the Products that it requires, as further set forth in this Article 5.

 

(b)                                  To the best of Manufacturer’s knowledge, as of the Effective Date, Manufacturer is not aware of any changes to Specifications and/or manufacturing, testing and packaging processes of the

 

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

 

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Products which are planned to be implemented during the Term, other than any upcoming changes as disclosed to Purchaser prior to the Effective Date.

 

5.2                                Mandatory Changes .  Manufacturer shall give Purchaser written notice prior to any changes to the manufacturing and production process of the Products (or changes related to Manufacturer’s Facility, to the extent that such changes could have a direct or indirect impact on the Products) that are required by cGMP or Applicable Law (collectively, “ Mandatory Changes ”).  If Purchaser refuses to approve a Mandatory Change or disputes whether a change constitutes a Mandatory Change, the Parties shall resolve such matter in accordance with the provisions of Article 18.

 

5.3                                Discretionary Changes .  Either Party may submit to the other Party written proposals of changes to the manufacturing and production process for the Products other than Mandatory Changes (collectively, “ Discretionary Changes ”).  Manufacturer shall implement Discretionary Changes upon the written consent of the non-requesting Party, which consent shall not be unreasonably withheld, conditioned or delayed.

 

5.4                                Costs of Changes .  Subject to Section 1.4, any and all costs associated with Mandatory Changes that primarily relate to the manufacturing, packaging, testing and supply of Products for distribution in the United States (including Regulatory Authority filings, write off and other costs due to such changes associated with obsolete Raw Materials, work-in-process and Products inventories) shall be borne by Purchaser and the costs of all other Mandatory Changes shall be borne by Manufacturer. Any and all costs associated with Discretionary Changes shall be paid by the Party requesting such changes. Each Party shall reasonably document such costs and provide such documentation upon request to the Party bearing or paying for such costs.

 

6.                                       Term

 

The term of this Supply Agreement shall commence on the Effective Date and shall continue until the last day of the Scale-Up Period, unless sooner terminated as expressly provided for in this Supply Agreement (the “ Term ”).

 

7.                                       Termination

 

7.1                                Material Breach .  This Supply Agreement may be terminated by either Party by giving

 

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

 

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written notice to the other Party if the other Party (the “ Breaching Party ”) is in material breach or default of any of its obligations hereunder (including any payment obligations) as follows: (a) the terminating Party must send written notice of the material breach or material default to the Breaching Party; and (b) the termination shall become effective sixty (60) days after receipt of such written notice by the Breaching Party, unless either (i) the Breaching Party has cured such material breach or default prior to the expiration of such sixty (60) day period or (ii) if such material breach or material default is not capable of being cured within such sixty (60) day period, the Breaching Party has commenced activities reasonably expected to cure such material breach or material default within such sixty (60) days period and thereafter uses diligent efforts to complete the cure as soon as practicable, provided that, if such material breach or default is not cured within one hundred twenty (120) days after receipt of such written notice by the Breaching Party, the termination shall become effective upon the expiration of such one hundred twenty (120) day period.

 

7.2                                Insolvency .  Either Party may terminate this Supply Agreement without prior notice to the other upon the occurrence of any of the following involving the other Party:

 

(a)                                  the other Party files a petition seeking an order for relief under the Federal Bankruptcy Code (Title 11 of the United States Code), as now or hereafter in effect, or under similar law (including laws in countries or jurisdictions other than the United States), or files a petition in bankruptcy or for reorganization or for an arrangement pursuant to any state bankruptcy law or any similar state or local law (including laws in countries or jurisdictions other than the United States); or

 

(b)                                  an involuntary case against the other Party as debtor is commenced by a petition under the Federal Bankruptcy Code (Title 11 of the United States Code), as now or hereafter in effect, or under similar law (including laws in countries or jurisdictions other than the United States), or a petition or answer proposing the adjudication of the other Party as a bankrupt or its reorganization pursuant to any state bankruptcy law or any similar state or local law (including laws in countries or jurisdictions other than the United States) is filed in any court and not dismissed, discharged or denied within sixty (60) days after the filing thereof; or

 

(c)                                   a custodian, receiver, United States Trustee, trustee or liquidator of the other Party or of all or substantially all of the other Party’s property is appointed in any proceedings brought by the other Party; or

 

(d)                                  a custodian, receiver, United States Trustee, trustee or liquidator is appointed in any proceedings brought against the other Party and is not be discharged within sixty (60) days after that

 

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

 

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appointment, or if the other Party consents to or acquiesces in such appointment; or

 

(e)                                   the other Party generally does not pay its debts as those debts become due, or makes an assignment for the benefit of creditors, or admits in writing its inability to pay its debts generally as they become due.

 

7.3                                Termination of Obligation to Supply .  Manufacturer shall have the right to terminate this Supply Agreement by giving six (6) months notice to Purchaser at any time after the date that is three (3) months after the date on which the Product manufacturing process at Purchaser’s Facility is successfully validated; provided , however :

 

(a)                                  in the event (i) the quantities of Seller Products set forth in the most recent Forecast provided by Manufacturer pursuant to Section 4.2(a)(iv) are [***], this Supply Agreement will not be terminated pursuant to this Section 7.3 unless and until Purchaser and Manufacturer discuss in good faith and agree upon a plan to meet such requirements; and

 

(b)                                  in the event [***] this Supply Agreement will not be terminated pursuant to this Section 7.3 unless [***].

 

7.4                                Effects of Termination or Expiration . In the event of termination or expiration of this Supply Agreement, the following provisions shall apply:

 

(a)                                  All Purchase Orders of the Products not yet manufactured shall automatically be deemed cancelled, and Manufacturer shall have no further obligation to supply Purchaser with such Products.

 

(b)                                  Purchaser shall be obligated to purchase (i) all Products manufactured or in the process of being manufactured and covered by the Binding Period and (ii) any and all Inventory that exists on the effective date of termination and for which Manufacturer has no other use and cannot be used by Manufacturer.  Purchaser will purchase such Inventory from Manufacturer at a price equal to a cost plus basis of such Inventory.  Once purchased, Purchaser may request Manufacturer to destroy Inventory which cannot be used by Manufacturer; in this case, Manufacturer shall destroy the Inventory and Purchaser shall bear the out-of-pocket destruction costs.

 

(c)                                   Any expiration or termination of this Supply Agreement shall not release the Parties from liabilities or obligations accrued on or prior to the date of expiration or termination. The following provisions shall survive termination or expiration of this Supply Agreement indefinitely or for

 

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

 

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such shorter period as is provided in such Sections, along with any other provisions of this Supply Agreement that are necessary to interpret or give effect to any of the following provisions:  Sections 3.9 (Conflicts), 4.1 (Transfer of Manufacturing Equipment), 4.2 (Technology Transfer and Manufacturing Transition) (but only until the completion of the Technology Transfer, provided that Manufacturer’s obligation to provide reasonable support under Section 4.2(b) shall terminate upon the earlier of the completion of the Technology Transfer or six (6) months after the effective date of expiration or termination of this Supply Agreement), 4.3 (Post-Transfer Supply Agreement), 7 (Termination), 9.3 (Records), 9.4 (Inspection by Manufacturer), 10.1 (Quality Agreement), 10.4 (Corrective Action), 10.5 (Product Complaints), 10.6 (Liability for Corrective Actions) and 10.7 (Regulatory Inspections); and Articles 14 (Confidential Information), 15 (Public Announcements), 17 (Indemnification), 18 (Dispute Resolution) and 19 (Miscellaneous).

 

8.                                       Delivery

 

8.1                                Delivery Terms .

 

(a)                                  Manufacturer shall deliver all Products so ordered by Purchaser on the delivery date stated in each Purchase Order and as confirmed by Manufacturer in accordance with Section 3.5.

 

(b)                                  Manufacturer shall be responsible for the release of Products prior to the delivery date specified on the applicable Purchase Order, and shall issue the Certificate of Analysis and Certificate of Conformance immediately following the release of Products in Manufacturer’s quality system.

 

(c)                                   Manufacturer shall deliver Products ordered by Purchaser, [***] in a packaging configuration agreed upon in advance by the Parties (each a “ Delivery ”).  If Purchaser requires any special packaging for the transportation of Products, the cost thereof shall be separately invoiced to Purchaser.  The Certificate of Analysis, Certificate of Conformance and all documents relating to each shipment shall be available at the time the Products are picked up from Manufacturer’s Facility.  All shipments must be accompanied by a packing slip which describes the articles, including lot numbers, production date and shelf life for each article, states the purchase order number and shows the shipment’s destination.  Manufacturer shall promptly forward the original bill of lading or other shipping receipt for each shipment in accordance with Purchaser’s or its Affiliate’s instructions and work with Purchaser to complete all applicable DEA forms.  Manufacturer further agrees to promptly render, after delivery of

 

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

 

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goods or performance of services, correct and complete invoices to Purchaser or its Affiliate.

 

8.2                                Shortages and Manufacturing Constraints .  In the event that any manufacturing capacity constraint or shortage of Raw Materials required for completing the manufacturing, packaging and supply activities of Products set forth in this Supply Agreement in a timely manner occurs, or is reasonably anticipated to occur, Manufacturer shall promptly notify Purchaser of such constraint or shortage, its cause and, to the extent known, its expected duration.  In the event such constraint or shortage cannot be remediated by Manufacturer in a reasonable period of time, [***].

 

8.3                                Tolerance .  Notwithstanding the provisions of Section 8.1, each Purchase Order will be considered supplied in full if (a) the quantities of Products delivered are within a range of plus or minus [***] of the quantities ordered and (b) if delivery is within [***] of the required Delivery date set forth in such Purchase Order.

 

8.4                                Minimum Shelf Life Remaining for Products .  All Product supplied by Manufacturer to Purchaser under this Supply Agreement shall upon Delivery have not less than [***] shelf life remaining.

 

8.5                                Storage of Finished Product .  Manufacturer shall not provide handling and storage services to Purchaser for Products at Manufacturer’s Facility after Delivery as set forth in this Article 8.  In the event Manufacturer agrees, in its sole discretion, to store Products after Delivery for Purchaser upon Purchaser’s written request or if Purchaser’s carrier fails to pick up the Products after Delivery, Manufacturer shall have the right to charge Purchaser a reasonable storage fee per pallet of Products for all such pallets that are stored by Manufacturer for [***] after Delivery.

 

9.                                       Inspection

 

9.1                                Reserved.

 

9.2                                Inspection of Manufacturer’s Facility .

 

(a)                                  Purchaser shall have the right, upon reasonable notice to Manufacturer (and in no event less than [***] in advance) and during regular business hours, [***] to inspect and audit the specific areas of Manufacturer’s Facility where manufacturing, storage, testing and/or packaging services are performed pertaining to Products or Raw Materials, to assure compliance by Manufacturer with cGMP, GDP and applicable rules and regulations and with other provisions of this Supply Agreement;

 

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

 

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provided , however , that Manufacturer shall have the right to deny access to any areas in Manufacturer’s Facility where no such activities with respect to Products or Raw Materials are undertaken.

 

(b)                                  Within [***] of completing any audit hereunder, Purchaser shall submit to Manufacturer a written report outlining its findings and/or observations from any such audit. If deficiencies are discovered during an audit that could, in Purchaser’s opinion, prevent Manufacturer from satisfying the requirements of cGMP and Manufacturer in good faith disputes the observations or conclusions of Purchaser, then the Parties shall promptly enter into good faith discussions to resolve their differences.  If the Parties fail to resolve their differences within [***] after receipt of the audit report, then the matter shall be promptly referred to a third party independent expert mutually acceptable to the Parties.  The third party independent expert shall render an opinion based on the audit report and its own observations within [***] from the start of its assignment.  Such opinion shall be binding on the Parties. The fee of the third party independent expert [***].  If Manufacturer does not dispute the observations of Purchaser made during an audit or if the observations of Purchaser have been confirmed by the third party independent expert, Manufacturer shall provide a proposed corrective plan to Purchaser and the Parties shall in good faith discuss and agree on a final corrective action plan to remedy or cause the remedy of any deficiencies which may be noted in any such audit, including the appropriate apportionment of costs associated therewith.

 

9.3                                Records .  Purchaser shall have the right to audit Manufacturer’s records relating to its performance under this Supply Agreement. Manufacturer shall maintain all batch records and other manufacturing and analytical records related to Products manufactured hereunder, all records of shipments of Products and all validation data and other applicable records with respect to Products manufactured hereunder required under cGMP or the Quality Agreement for the greater of (a) the time period required by Applicable Law or (b) the time periods set forth in the Quality Agreement. Manufacturer shall in good faith work with Purchaser to make such data available to Purchaser and any Regulatory Authority upon Purchaser’s reasonable request or if required by Applicable Law.  To the extent that such records also include data or information that does not specifically pertain to Products or Raw Materials, Manufacturer shall be entitled to redact such data or information from such records prior to audit by or disclosure to Purchaser.

 

9.4                                Inspection by Manufacturer .  For so long as Purchaser is Distributing Products manufactured in Manufacturer’s Image, Manufacturer shall has the right to audit the warehousing facilities of Purchaser, to the same extent that Purchaser is permitted to audit Manufacturer’s Facility

 

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

 

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pursuant to Section 9.2, only that Manufacturer will perform the audit through Purchaser (i.e. will not directly issue observations and requests for corrections to wholesaler).

 

10.                                Quality; Defective Products; Regulatory Inspections; Testing

 

10.1                         Quality Agreement .  The Parties are entering into a Quality Agreement regarding the production by Manufacturer of Raw Materials and Products (the “ Quality Agreement ”) on the Effective Date.  To the extent there are any inconsistencies or conflicts between this Supply Agreement and the Quality Agreement, the terms and conditions of this Supply Agreement shall control except with respect to quality matters.

 

10.2                         Disposition of Defective Products .

 

(a)                                  Purchaser shall, as soon as practical (and, in any event, within [***]) after receipt of any Delivery of Products, notify Manufacturer of the existence and nature of any Visible Defects in such Products.

 

(b)                                  Purchaser shall, as soon as practical (and, in any event, within [***]) after the day on which Purchaser became aware or should reasonably have become aware of a Hidden Defect in any Products, notify Manufacturer of the existence and nature of such Hidden Defect in such Products.

 

(c)                                   If notice of a Visible Defect or Hidden Defect is not provided within the applicable time period stated above, then all such Products shall be deemed to be in compliance with this Supply Agreement.

 

(d)                                  If Purchaser notifies Manufacturer of the existence and nature of any Defective Products during the applicable time period, Manufacturer shall have a reasonable opportunity, not to exceed [***] from receipt of notification, to inspect such Defective Products (provided Purchaser has provided Manufacturer appropriate samples of the impacted shipments of Products) and provide Purchaser with detailed written instructions to return or dispose of such Defective Products. Subject to the provisions of Section 10.6, Manufacturer shall replace Defective Products at its own cost and expense, including reimbursement of freight and disposition costs incurred by Purchaser.

 

10.3                         Independent Testing .  If, after Manufacturer’s inspection of any Product alleged by Purchaser to be Defective Product, the Parties disagree as to whether such Product is Defective Product,

 

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

 

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the Parties shall deliver such Product to an independent third party laboratory, mutually selected by the Parties, for analytical testing to verify the Product’s conformance to the Specifications.  All costs associated with such third party testing shall be at the expense of the [***].  The report of the independent third party laboratory shall be binding on the Parties.

 

10.4                         Corrective Action .  In the event any governmental agency having appropriate jurisdiction requests or orders, or Purchaser determines to undertake, any corrective action with respect to any Products supplied under this Supply Agreement, including any recall or market withdrawal, corrective action or market action (a “ Corrective Action ”), the Parties shall cooperate in the handling and disposition of such Corrective Action and the replacement of such Products.  Purchaser will have the right to make a final determination as to the initiation of any such Product withdrawal or recall.

 

10.5                         Product Complaints .  The Parties shall notify one another of any complaints relating to Products supplied under this Supply Agreement in accordance with the Quality Agreement.

 

10.6                         Liability for Corrective Actions .  In case of a Corrective Action caused by a Defective Product (other than a Visible Defect), Manufacturer will [***].  The conduct of any recall of Products supplied under this Supply Agreement shall be the sole responsibility of Purchaser. Subject to the liability limitations set forth in Section 17.4, Manufacturer will [***].

 

10.7                         Regulatory Inspections .  In the event Manufacturer’s Facility is the subject of an inspection by any Regulatory Authority or any other duly authorized agency of any national, state or local government directly relating to the manufacturing, packaging or warehousing of the Products, Manufacturer shall notify Purchaser within [***] of learning of such inspection, and shall, if reasonably possible given the circumstances, afford Purchaser the opportunity to be present at such inspection. Manufacturer shall supply Purchaser with redacted copies of any correspondence or portions of correspondence to the extent relating to the Products. In the event Manufacturer receives any regulatory letter or written comments from any Regulatory Authority in connection with manufacturing and packaging of the Products under this Supply Agreement, it shall provide Purchaser with a copy of each such communication. To the extent Manufacturer is required to submit any correspondence to a Regulatory Authority that relates to the manufacture, packaging or warehousing of the Products, Manufacturer shall provide Purchaser with a copy of such correspondence as far in advance of its submission to such Regulatory Authority as possible and Purchaser shall have the opportunity to review and comment upon such correspondence. Purchaser will cooperate fully with Manufacturer in its

 

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

 

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interactions and correspondence with Regulatory Authorities in furtherance of this Section.

 

10.8                         Safety .  Manufacturer shall enforce safety procedures for its manufacturing, packaging and storing of the Products and Raw Materials and handling and disposal of waste relating thereto that comply with all environmental and occupational safety and health laws.  Such responsibilities shall include the proper disposal of waste in an appropriate manner consistent with the nature of the waste and at a permitted disposal facility.

 

10.9                         Storage .  To the extent any Products or Raw Materials are stored, Manufacturer shall store such Products and Raw Materials in a controlled environment that meets the Specifications, cGMP and all other Applicable Laws.

 

11.                                Force Majeure

 

11.1                         Neither Party will be liable for non-performance or delay in the fulfillment of its obligations under this Supply Agreement if such non-performance or delay is occasioned by any cause beyond the reasonable control of Purchaser or Manufacturer, as the case may be, including acts of God, fire, flood, earthquakes, explosions, sabotage, strikes, or labor disturbances (regardless of the reasonableness of the demands of the labor force), civil commotion, riots, military invasions, wars, failure of utilities, failure of carriers, inability to obtain any required raw material, energy source, equipment, labor or transportation, at prices and on terms Manufacturer deems practicable from its usual sources of supply or any acts, restraints, requisitions, regulations, or directives issued by a competent Governmental Authority, including changes in Law (each, a “ Force Majeure Event ”); provided , however , a Force Majeure Event shall never excuse a Party from paying any sum of money owed under this Supply Agreement.

 

11.2                         In the event that either Party is prevented from discharging its obligations under this Supply Agreement on account of a Force Majeure Event, such Party shall promptly notify the other Party, and shall nevertheless make reasonable, good faith efforts to discharge its obligations, even if in a partial or compromised manner.  In the event that a Force Majeure Event continues for a period of [***], or for periods which aggregate [***] during any [***], the Party not claiming the Force Majeure Event will be entitled to terminate this Supply Agreement forthwith, but without penalty or liability to the Party affected by the Force Majeure Event, on written notice to the Party claiming the Force Majeure Event, provided that such termination shall not affect any Party’s right to receive amounts which have accrued or

 

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

 

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became due prior to the termination.

 

11.3                         The Party affected by a Force Majeure Event shall use commercially reasonable efforts to limit the effects of a Force Majeure Event upon its performance of this Supply Agreement and shall notify the other Party, immediately, of the cessation of the Force Majeure Event.

 

12.                                Insurance

 

Manufacturer shall procure and maintain in full force and effect during the term of this Supply Agreement valid insurance policies or a program of self-insurance in connection with its activities as contemplated hereby.

 

13.                                Labelling

 

Purchaser shall be responsible at its own expense for developing and approving the labeling and packaging material for the Products in the Purchaser’s Image (including without limitation for the design and production of all related artwork) and for obtaining all approvals from Regulatory Authorities necessary to manufacture, market, promote, distribute and sell Products in the Purchaser’s Image in accordance with Section 1.2.

 

14.                                Confidential Information

 

The existence, subject matter and contents of this Supply Agreement are confidential and constitute Confidential Information and the terms and conditions relating to the disclosure of this Supply Agreement (or any related information) are governed by Section 6.26 of the Asset Purchase Agreement.

 

15.                                Public Announcements

 

The terms and conditions relating to the making of any public announcements on this Supply Agreement shall be governed by Section 6.04 of the Asset Purchase Agreement.

 

16.                                Representations and Warranties

 

16.1                         Product Warranties .  Manufacturer represents and warrants to Purchaser that all Products

 

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

 

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supplied under this Supply Agreement shall be manufactured and provided in accordance and conformity with the Specifications and in accordance with Applicable Law. MANUFACTURER MAKES NO OTHER WARRANTIES OR REPRESENTATION OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY OTHER MATTER WITH RESPECT TO THE PRODUCT.

 

16.2                         Execution and Performance of Agreement .  Each Party represents to the other Party that it has full right, power and authority to enter into and perform its obligations under this Supply Agreement. Each Party further represents and warrants to the other Party, as of the Effective Date, that the performance of its obligations under this Supply Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment or obligation to which such Party is a party or by which it is bound.

 

16.3                         GMP Compliance Warranty .  Manufacturer represents and warrants to Purchaser that the Products manufactured, packaged and supplied under this Supply Agreement shall be GMP compliant.

 

17.                                Indemnification

 

17.1                         Indemnification by Purchaser .  Subject to the limitations set forth in Section 17.5 and excluding those matters for which Manufacturer is obligated to indemnify Purchaser pursuant to this Supply Agreement, Purchaser shall indemnify and hold Manufacturer and its Affiliates and their respective directors, officers, employees, agents, consultants, subcontractors, representatives, successors and assigns (collectively, the “ Manufacturer Indemnified Parties ”) harmless from and against any and all Losses incurred by Manufacturer Indemnified Parties to the extent arising from or relating to (a) any action, claim or proceeding instituted by a third party in connection with the distribution, promotion or sale in the United States of Products supplied under this Supply Agreement, including product liability claims (except to the extent such Product is a Defective Product, the defect is not a Visible Defect and the action, claim or proceeding arises directly from such defect); or (b) any breach of any representation, warranty or obligation of Purchaser contained in this Supply Agreement.  This Section 17.1 provides the sole recourse and exclusive means by which any Manufacturer Indemnified Party may assert and remedy any Losses arising under or with respect to this Supply Agreement.

 

17.2                         Indemnification by Manufacturer .  Subject to the limitations set forth in Section 17.4 and excluding those matters for which Purchaser is obligated to indemnify Manufacturer pursuant to this

 

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

 

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Supply Agreement, Manufacturer shall indemnify and hold Purchaser and its Affiliates their respective directors, officers, employees, agents, consultants, subcontractors, representatives, successors and assigns (collectively, the “ Purchaser Indemnified Parties ”) harmless from and against any and all Losses incurred by Purchaser Indemnified Parties to the extent arising from or relating to (a) any action, claim or proceeding instituted by a third party in connection with a Defective Product supplied by Manufacturer to Purchaser under this Supply Agreement (other than in case of a Visible Defect); or (b) any breach of any representation, warranty or obligation of Manufacturer contained in this Supply Agreement.  This Section 17.2 provides the sole recourse and exclusive means by which any Purchaser Indemnified Party may assert and remedy any Losses arising under or with respect to this Supply Agreement.

 

17.3                         Claims .

 

(a)                                  Any Purchaser Indemnified Party or Manufacturer Indemnified Party claiming it may be entitled to indemnification under this Supply Agreement (the “ Indemnified Party ”) shall give prompt written notice to the other Party (the “ Indemnifying Party ”) of each matter, action, cause of action, claim, demand, fact or other circumstance upon which a claim for indemnification (the “ Claim ”) may hereunder be based, and the Indemnifying Party shall have the right to defend such Claim, provided that the failure to give such notice shall not affect the Indemnified Party’s rights to indemnification, except to the extent that the Indemnifying Party is actually prejudiced thereby.  The Indemnifying Party shall have control over the Claim; provided, however, that the Indemnifying Party shall not be entitled to assume or maintain control of the defense of a third party Claim and shall pay the fees and expenses of counsel retained by the Indemnified Party if (i) such third party Claim relates to or arises in connection with any criminal Legal Proceeding, (ii) such third party Claim seeks an injunction or equitable relief against the Indemnified Party or any of its Affiliates, (iii) such third party Claim seeks monetary damages and the sum of the amount of the monetary damages is greater than twice the maximum amount from which the Indemnifying Party is required to indemnify the Indemnified Party under this Supply Agreement, (iv) the Indemnified Party reasonably concludes, based on the advice of counsel, that there is an irreconcilable conflict of interest between the Indemnifying Party and the Indemnified Party in the conduct of such defense or (v) after assuming control of such defense, the Indemnifying Party withdraws from such defense or fails to diligently pursue and maintain such defense.

 

(b)                                  If the Indemnifying Party is controlling a third party Claim, the Indemnifying Party may compromise or settle such Claim; provided, however, that the Indemnifying Party shall not, absent the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed), consent to the entry of any judgment or enter into any compromise or settlement (a) that provides for any relief other than the payment of monetary damages for which the Indemnifying Party shall be solely liable or (b) where the claimant or plaintiff does not release the Indemnified Party, its Affiliates and their respective directors, officers, employees, Affiliates, agents, consultants, subcontractors, representatives successors and assigns, as the case may be, from all liability in respect thereof.  No Indemnified Party may compromise or settle any third party Claim for which it is seeking indemnification hereunder without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed.

 

(c)                                   The Parties shall cooperate in the defense of any third party Claim.  The Indemnified Party shall have the right, at its own expense, to participate in the defense of any third party Claim.  The Indemnifying Party shall keep the Indemnified Party reasonably apprised of the status of the defense of such Claim.

 

17.4                         Limitation on Manufacturer’s Liability .  Manufacturer’s maximum liability to Purchaser in any calendar year under this Supply Agreement, including its indemnity obligations, shall not exceed the greater of (a) thirty million dollars ($30,000,000) or (b) the total amount paid by Purchaser to Manufacturer under this Supply Agreement for the prior completed calendar year, except with respect to damages or claims resulting from Manufacturer’s gross negligence, fraud, willful misconduct or breach of confidentiality obligations.

 

17.5                         Limitations of Purchaser’s Liability Purchaser’s maximum liability towards Manufacturer (including any liability for the acts and omissions of any of its Affiliates or any of its or their respective directors, officers, employees, Affiliates, agents, consultants, subcontractors,  representatives, successors or assigns), and the sole remedy of the Manufacturer, for breach of Purchaser’s obligation to order, take delivery of or pay for Products shall be a claim for monetary damages equal to the purchase price thereof, increased by an amount calculated using the Default Interest Amount as provided herein and any direct costs arising from such breach (limited to costs of disposal or shipping of Products or Raw Materials or write-offs related thereto), except with respect to damages or claims resulting from Purchaser’s gross negligence, fraud, willful misconduct or breach of confidentiality obligations.  Except with respect to breaches described in the immediately preceding sentence (which shall be subject to the limitations set forth in the immediately preceding sentence), Purchaser’s maximum liability to Manufacturer Indemnified Parties in any calendar year under this Supply Agreement, including its indemnity obligations, shall not exceed the greater of (a) thirty million dollars ($30,000,000) or (b) the total amount paid plus any amounts payable by Purchaser to Manufacturer under this Supply Agreement for the prior completed calendar year, except with respect to damages or claims resulting from Purchaser’s gross negligence, fraud, willful misconduct or breach of confidentiality obligations.

 

17.6                         WAIVER OF DAMAGES .  EXCEPT FOR RELIEF MANDATED BY STATUTE OR

 

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

 

36



 

ANY BREACH OF ARTICLE 14, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS OR LOSS OF OPPORTUNITY), OR LOST PROFITS EVEN IF DESIGNATED DIRECT DAMAGES, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF; PROVIDED , HOWEVER , THAT THE FOREGOING SHALL NOT BE CONSTRUED TO PRECLUDE RECOVERY IN RESPECT OF ANY LOSS DIRECTLY INCURRED OR SUFFERED FROM THIRD PARTY CLAIMS FOR WHICH ONE PARTY IS OBLIGATED TO INDEMNIFY THE OTHER PARTY (OR AN INDEMNITEE OF SUCH OTHER PARTY) PURSUANT TO THIS ARTICLE 17.

 

18.                                Dispute Resolution

 

Any controversy or claim between the Parties arising out of or relating to this Supply Agreement shall be resolved in accordance with Section 10.11 of the Asset Purchase Agreement.

 

19.                                Miscellaneous

 

19.1                         Relationship of the Parties .  The relationship of Purchaser and Manufacturer established by this Supply Agreement is that of independent contractors, and nothing contained herein shall be construed to:

 

(a)                                  give either Party any right or authority to create or assume any obligation of any kind on behalf of the other; or

 

(b)                                  constitute the Parties as partners, joint ventures, co-owners or otherwise as participants in a joint or common undertaking.

 

19.2                         Third Party Rights .  Nothing in this Supply Agreement shall be deemed to create any third party beneficiary rights in or on behalf of any other person.

 

19.3                         Entire Agreement; Modifications .  This Supply Agreement, together with the Quality Agreement and including the Appendices hereto which are incorporated by reference, constitutes the entire agreement of the Parties with respect to its subject matter and supersedes all prior agreements,

 

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

 

37



 

arrangements, dealings and writings between the Parties that relate to the matters covered herein.  Any terms and conditions of an invoice, acknowledgement or similar document provided by Manufacturer for Products, or any terms and conditions of Purchase Orders provided by Purchaser for Products, that are inconsistent with or in addition to the terms of this Supply Agreement shall be null and void.  This Supply Agreement may not be amended or modified except in writing executed by the duly authorized representatives of both Parties.

 

19.4                         Headings .  The Article and Section headings contained in this Supply Agreement are for reference purposes only and shall not affect in any way the meaning and interpretation of this Supply Agreement.

 

19.5                         Notices .  All notices, requests, demands and other communications under this Supply Agreement shall be in writing and shall be deemed to have been duly given if delivered, addressed or telecopied to the address or telecopier number set forth below and shall be deemed to have been made:  (a) on the date of service, if served personally on the Party; (b) on the second business day after delivery to an overnight courier service, if first available delivery is indicated and paid for; (c) on the third business day after mailing, if mailed to the Party to whom notice is to be given, by first class mail, registered or certified, postage prepaid; or (iv) on the date of transmission, if sent by telecopier and confirmation of transmittal is received by the transmitting Party.  Any Party may change its address for purposes of this Section by giving the other Party’s written notice of the new address in the manner set forth above.

 

If to Manufacturer:                                      Janssen Ortho LLC

State Road 933 Km 0.1

Mamey Ward

HC 02, Box 19250

Gurabo, Puerto Rico 00778

Attn: General Manager

Facsimile: (787) 272-7691

 

and

 

Janssen Pharmaceuticals, Inc.

c/o Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Attn: Assistant General Counsel, Corporate Legal Department

Facsimile: (752) 524-5334

 

If to Purchaser:                                                             Depomed, Inc.

7999 Gateway Boulevard, Suite 300

Newark, California 94560

Attn: Legal Department

Facsimile: (510) 744-8001

 

19.6                         Failure to Exercise .  The failure of either Party to enforce at any time for any period any

 

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

 

38



 

provision hereof shall not be construed to be a waiver of such provision or of the right of such Party thereafter to enforce each such provision, nor shall any single or partial exercise of any right or remedy hereunder preclude any other or further exercise thereof or the exercise of any other right or remedy. Remedies provided herein are cumulative and not exclusive of any remedies provided at law.

 

19.7                         Assignment .  This Supply Agreement, or any of the rights or obligations under this Supply Agreement, may not be assigned or otherwise transferred by a Party without the prior written consent of the other Party; provided , however , that (i) either Party may, without such consent, but with notice to the other Party, assign this Supply Agreement, or any of its rights or obligations under this Supply Agreement, in whole or in part: (a) in connection with the transfer or sale of all or substantially all of such Party’s assets or the line of business for the Products; (b) to a successor entity or acquirer in the event of a sale, merger, consolidation, change of control or similar transaction of such Party; or (c) to any Affiliate of such Party (in that case, so long as such assigning Party remains fully liable for all of its obligations hereunder as a primary obligor); and (ii) Purchaser may, without such consent, but with notice to Manufacturer, assign this Supply Agreement, or any of its rights or obligations under this Supply Agreement, (A) to any lender of Purchaser or purchaser of securities used to finance the Transactions or the transactions contemplated by this Supply Agreement as collateral security to secure the obligations of any indebtedness or Purchaser or (B) in connection with any transaction the primary purpose of which is to change the domicile of Purchaser.  Any purported assignment in violation of the preceding sentence will be void. Any permitted assignee will assume the rights and obligations of its assignor under this Supply Agreement.

 

19.8                         Severability .  In the event that any one (1) or more of the provisions (or any part thereof) contained in this Supply Agreement or in any other instrument referred to herein, shall, for any reason, be held to be invalid, illegal or unenforceable in any respect pursuant to a final, non-appealable decision in accordance with the dispute resolution provisions set forth in Article 18, then to the maximum extent permitted by law, such invalidity, illegality or unenforceability shall not affect any other provision of this Supply Agreement or any other such instrument. Any term or provision of this Supply Agreement which is invalid, illegal or unenforceable in any jurisdiction shall, to the extent the economic benefits conferred by this Supply Agreement to both Parties remain substantially unimpaired, not affect the validity, legality or enforceability of any of the terms or provisions of this Supply Agreement in any other jurisdiction.

 

19.9                         Expenses .  Each Party shall pay all of its own fees and expenses (including all legal, accounting and other advisory fees) incurred in connection with the negotiation and signature of this

 

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

 

39



 

Supply Agreement and the arrangements contemplated hereby.

 

19.10                  Use of Affiliates .  Each Party shall be entitled to delegate the performance of one or more of its obligations hereunder to one or more of its Affiliates, provided that such Party shall at all times remain responsible towards the other Party for the performance of such delegated tasks.

 

19.11                  Interpretation .

 

(a)                                  The words “hereof”, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Supply Agreement, shall refer to this Supply Agreement as a whole and not to any particular provision of this Supply Agreement.

 

(b)                                  The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

 

(c)                                   The terms “U.S. Dollars” and “$” shall mean lawful currency of the United States of America.

 

(d)                                  The terms “include,” “includes” and “including” shall mean “including, without limitation.”

 

(e)                                   When a reference is made in this Supply Agreement to an Article, a Section, an Appendix or a Schedule, such reference shall be to an Article or a Section of, or an Appendix or a Schedule to, this Supply Agreement unless otherwise indicated.

 

(f)                                    Time periods based on a number of days 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, if applicable, by extending the period to the next business day following if the last day of the period is not a business day.

 

(g)                                   The term “United States” shall refer to the United States of America and its territories, including Puerto Rico.

 

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

 

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

 

40



 

shall become effective when one or more counterparts have been signed by each of the Parties and delivered to the other Party, it being understood that both Parties need not sign the same counterpart.  This Supply Agreement, following its execution, may be delivered via telecopier machine or other form of electronic delivery, which shall constitute delivery of an execution original for all purposes.

 

[Remainder of the page intentionally blank]

 

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

 

41



 

IN WITNESS of which the Parties have entered into this Supply Agreement as of the Effective Date.

 

 

JANSSEN ORTHO LLC

 

 

 

 

 

 

By:

/s/ John O’Hara

 

Name:

John O’Hara

 

Title:

General Manager

 

 

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

 

[Signature Page to Transitional Supply Agreement]

 



 

JANSSEN PHARMACEUTICALS, INC.

 

 

 

 

 

 

By:

/s/ Michael Grissinger

 

Name:

Michael Grissinger

 

Title:

Authorized Signatory

 

 

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

 

[Signature Page to Transitional Supply Agreement]

 



 

DEPOMED, INC.

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

Name:

James A. Schoeneck

 

Title:

President and Chief Executive Officer

 

 

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

 

[Signature Page to Transitional Supply Agreement]

 



 

APPENDICES

 

Appendix A:                           Products

Appendix B:                           ER Line 1

Appendix C:                           ER Line 2

Appendix D:                           Seller Countries

Appendix E:                           Supply Prices

Appendix F:                            Technology Transfer and Manufacturing Transition Plan

 

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

 



 

APPENDIX A

 

Products

 

[***](1)

 


(1) Five pages omitted and filed separately with the Commission.

 

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

 



 

APPENDIX B

 

ER Line 1

 

[***](2)

 


(2) One page omitted and filed separately with the Commission.

 

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

 



 

APPENDIX C

 

ER Line 2

 

[***](3)

 


(3) One page omitted and filed separately with the Commission.

 

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

 



 

APPENDIX D

 

Seller Countries

 

Canada

Hong Kong

Indonesia

Japan

Malaysia

Singapore

Thailand

Philippines

Vietnam

 

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

 



 

APPENDIX E

 

Supply Prices

 

[***](4)

 


(4) One page omitted and filed separately with the Commission.

 

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

 



 

APPENDIX F

 

Technology Transfer and Manufacturing Transition Plan

 

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

 


Exhibit 10.5

 

CERTAIN MATERIAL (INDICATED BY [***] ) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SUPPLY AGREEMENT

 

THIS SUPPLY AGREEMENT (this “ Agreement ”) is made as of April 2, 2015 (the “ Effective Date ”), by and between Noramco, Inc., a Georgia corporation, with offices at 500 Swedes Landing Road, Wilmington, Delaware 19801 (“ Noramco ”) and Depomed, Inc., a California corporation located at 7999 Gateway Boulevard, Suite 300, Newark, California 94560 (hereinafter referred to as “ Purchaser ”).  Noramco and Purchaser may be referred to herein as a “ Party ” or “ Parties ” as the context may require.

 

RECITALS

 

WHEREAS, Noramco is engaged in the business of manufacturing and selling active pharmaceutical ingredients, including tapentadol (“ API ”);

 

WHEREAS, Janssen Pharmaceuticals, Inc. (“ Seller ”), an Affiliate of Noramco, and Purchaser are parties to that certain Asset Purchase Agreement, dated as of January 15, 2015 (the “ Asset Purchase Agreement ”), pursuant to which Seller agreed to sell, and Purchaser agreed to purchase, certain rights and assets related to the products containing API set forth on Appendix A (the “ Products ”), and Purchaser agreed to assume certain liabilities related to the Products, in the United States (the “ Transaction ”);

 

WHEREAS, prior to the Effective Date, Noramco manufactured and supplied API to Seller and its Affiliates for use in the commercial manufacture of Products for distribution in the United States;

 

WHEREAS, pursuant to Section 6.07 of the Asset Purchase Agreement, Purchaser and Seller (or its Affiliate) agreed to enter into an API supply agreement pursuant to which, following the closing of the Transaction, Seller or its Affiliate would manufacture and supply Purchaser’s requirements of API for use in (i) the validation and qualification of Purchaser’s facility for the manufacture of Products and (ii) following the validation and qualification of Purchaser’s facility, the manufacture of Purchaser’s requirements of finished Products for distribution in the United States, on the terms set forth in Exhibit D to the Asset Purchase Agreement; and

 

WHEREAS, Purchaser wishes to purchase API, and Noramco is willing to supply API to Purchaser, on the terms and conditions of this Agreement.

 

NOW THEREFORE, INTENDING TO BE LEGALLY BOUND HEREBY AND IN CONSIDERATION OF THE MUTUAL REPRESENTATIONS, WARRANTIES AND COVENANTS SET FORTH IN THIS AGREEMENT AND OTHER GOOD AND VALUABLE CONSIDERATION THE RECEIPT AND SUFFICIENCY OF WHICH IS HEREBY ACKNOWLEDGED, THE PARTIES AGREE AS FOLLOWS:

 

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

 



 

DEFINITIONS

 

For purposes of this Agreement, the following words or expressions have the meanings provided below:

 

AAA ” shall have the meaning set forth in Section 19.1.

 

AAA Rules ” shall have the meaning set forth in Section 19.2.

 

Action ” shall have the meaning set forth in Section 10.1.

 

Affiliate ” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such Person at any time during the period for which the determination of affiliation is being made.  For purposes of this definition, “control” of a Person means the power, direct or indirect, to direct or cause the direction of the management and policies of such Person whether by contract or otherwise and, in any event and, without limitation of the previous sentence, any Person owning more than fifty percent (50%) or more of the voting securities of another Person shall be deemed to control that Person.

 

Agreement ” shall have the meaning set forth in the preamble to this Agreement.

 

API ” shall have the meaning set forth in the Recitals.

 

API Manufacturing Patents ” mean United States Patent No. [***] and United States Patent No. [***].

 

Asset Purchase Agreement ” shall have the meaning set forth in the Recitals.

 

Breaching Party ” shall have the meaning set forth in Section 13.2.

 

cGMP ” means current good manufacturing practices as required by the rules and regulations of the FDA, as applicable to the manufacturing, packaging, handling, storage and control of API.

 

Commercial Use ” shall have the meaning set forth in Section 1.3.

 

Confidential Information ” shall have the meaning set forth in Section 11.5.

 

DEA ” means the Drug Enforcement Administration of the US Department of Justice or any successor organization.

 

Dispute ” shall have the meaning set forth in Section 19.1.

 

DMF ” means the Drug Master File as filed with the FDA by Noramco or its Affiliates.

 

Effective Date ” shall have the meaning set forth in the preamble to this Agreement.

 

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

 

Finished Good Tapentadol ” means the amount of API contained in the finished Product, as calculated in the manner set forth on Appendix D , manufactured at a Seller facility (using the standard

 

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

 

2



 

manufacturing practices at such Seller facility) and sold to Purchaser under the Transitional Supply Agreement for Commercial Use only in the United States.

 

Force Majeure Events ” shall have the meaning set forth in Section 16.1.

 

Forecast ” shall have the meaning set forth in Section 3.1.

 

Indemnified Party ” shall have the meaning set forth in Section 10.3.

 

Indemnifying Party ” shall have the meaning set forth in Section 10.3.

 

Infringement Claim ” has the meaning set forth in Section 12.2.

 

Initial Price Term ” shall mean the term commencing on the Effective Date and ending on [***].

 

Initial Term ” shall have the meaning set forth in Section 13.1.

 

J&J Calendar Year ” shall mean a calendar year based on the Johnson & Johnson Universal Calendar.

 

Losses ” shall have the meaning set forth in Section 10.1.

 

Manufacturing Interruptions ” shall have the meaning set forth in Section 8.1.

 

Manufacturing Quota ” means the amount of an API allotted to Noramco by the DEA pursuant to applicable DEA regulations so that Noramco may manufacture API.

 

Manufacturing Quota Restrictions ” shall have the meaning set forth in Section 8.2.

 

Non-Commercial Use ” shall have the meaning set forth in Section 1.1.

 

Nonconforming API ” shall have the meaning set forth in Section 6.1.

 

Noramco ” shall have the meaning set forth in the preamble to this Agreement.

 

Noramco Indemnitee ” shall have the meaning set forth in Section 10.1.

 

Party/Parties ” shall have the meaning set forth in the preamble to this Agreement.

 

Person ” means an individual, a limited liability company, a joint venture, a corporation, a partnership, an association, a trust, a division, unincorporated organization, or an operating group of any of the foregoing or any other entity or organization, whether governmental or otherwise.

 

Post-Transfer Supply Agreement ” shall have the meaning set forth in the Asset Purchase Agreement.

 

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

 

3



 

Procurement Quota ” means the quota allotted to Purchaser by the DEA pursuant to applicable DEA regulations so as to permit shipment of API from Noramco to Purchaser.

 

Procurement Quota Restrictions ” shall have the meaning set forth in Section 8.3.

 

Products ” shall have the meaning set forth in the Recitals.

 

Purchase Order ” shall have the meaning set forth in Section 3.3.

 

Purchaser ” shall have the meaning set forth in the preamble to this Agreement.

 

Purchaser Indemnitee ” shall have the meaning set forth in Section 10.2.

 

Purchaser’s Facility ” means the manufacturing facility of Purchaser (or its designee).

 

Quality Agreement ” means the agreement related to quality assurance and control entered into between Purchaser and Seller as of the date hereof.

 

Regulatory Authority ” means any and all governmental bodies and organizations regulating the manufacture, importation, distribution, use and/or sale of a Product.

 

Renewal Term ” shall have the meaning set forth in Section 13.1.

 

Seller ” shall have the meaning set forth in the Recitals.

 

Specification(s) ” means the API specification(s) contained in Appendix B , except as may be agreed in writing by Purchaser and Noramco as an amendment to this Agreement.

 

Supply Price ” shall have the meaning set forth in Section 4.1.

 

Term ” shall have the meaning set forth in Section 13.1.

 

Transaction ” shall have the meaning set forth in the Recitals.

 

Transition Period ” means the period beginning on the Effective Date and ending on the date that Purchaser commences the manufacture of any Product for Commercial Use at Purchaser’s Facility for distribution in the United States.

 

1.                                       SUPPLY

 

1.1.                             Subject to the terms and conditions of this Agreement, during the first [***] of the Term, Noramco shall supply to Purchaser, and Purchaser shall purchase from Noramco, [***] of Purchaser’s requirements of API and thereafter, Noramco shall supply to Purchaser, and Purchaser shall purchase from Noramco, [***] of Purchaser’s requirements of API; provided however, that beginning the first full J&J Calendar Year after the Transition Period, Purchaser shall purchase from Noramco a minimum annual volume of [***] of API during the Term,

 

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

 

4



 

subject to availability of Manufacturing Quota and Procurement Quota.  The calculation of the minimum annual volume of API shall include the Finished Good Tapentadol as calculated in accordance with Appendix D .  [***]

 

1.2.                             During the Transition Period, such API is for use in the qualification and validation of Purchaser’s facility for the manufacture of Products, clinical and non-clinical development of Products, or analytical testing or analytical development of Products (such use “ Non-Commercial Use ”).  Purchaser shall not use any API supplied by Noramco during the Transition Period for any purpose other than Non-Commercial Use without Noramco’s prior written consent.

 

1.3.                             After the Transition Period, such API is for use in the manufacture of Products for commercial distribution in the United States (such use “ Commercial Use ”).  Purchaser shall not use any API supplied by Noramco for any purpose other than Commercial Use or Non-Commercial Use without Noramco’s prior written consent.

 

1.4.                             Noramco shall use commercially reasonable efforts to supply Purchaser with API in the quantities and on the date(s) specified in each Purchaser purchase order. Noramco will use commercially reasonable efforts to supply Purchaser with impurity reference standards related to API at a commercially reasonable cost, with such impurity reference standards to be used only to support Purchaser’s analytical testing.

 

1.5.                             Purchaser will keep accurate records of its requirements of API during the Term, and, upon the request of Noramco, will permit Noramco or its duly authorized agents to examine such records during normal business hours for the purpose of verifying the correctness of all calculations in such records.

 

2.                                       PERMITS; DMF(S) AND cGMP

 

2.1.                             Noramco will be responsible for obtaining [***] any licenses or permits, and any regulatory and government approvals necessary for the manufacture of API, provided that Manufacturing Quota is addressed in Article 8 below.

 

2.2.                             Noramco [***] has filed or will file and shall maintain a valid DMF covering the API during the Term, all in accordance with all applicable laws, rules and regulations of the FDA or any other Regulatory Authority.

 

2.3.                             Noramco shall provide Purchaser with an access or right of reference letter entitling Purchaser to make continuing reference to the Noramco DMFs in connection with any regulatory filings made with the FDA by Purchaser with respect to Product.

 

2.4.                             Noramco shall provide a certificate of analysis with each shipment of API delivered hereunder.  All API sold to Purchaser under this Agreement will be manufactured in accordance with cGMP and conform to the Specifications.

 

2.5.                             A Party that desires a change in filed Specifications shall provide the other Party with its written request therefore, in a timely manner, and in no case, later than [***] before the Product made using the changed filed Specifications is delivered.  Requested changes shall be

 

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

 

5



 

implemented only if and after the other Party consents to them, which consent shall not be unreasonably withheld.  The Party requesting a change in filed Specifications shall bear the financial costs of implementing such change.

 

3.                                       FORECASTS AND PURCHASE ORDERS FOR API

 

3.1.                             On [***] throughout the Term, Purchaser shall provide to Noramco a [***] rolling ([***]), binding (except as set forth below) forecast (each a “ Forecast ”) of the anticipated monthly purchases of API under this Agreement, provided that the initial Forecast shall be provided to Noramco no later than [***] after the Effective Date.  The Forecast will include quantities for planned regulatory filings.  The [***] Forecast shall be binding on Purchaser and shall constitute a firm commitment by Purchaser to issue a purchase order for the API indicated for such months, subject to availability of Manufacturing Quota and Procurement Quota, provided , however , that if necessary in light of significant changes in the market for the Products due to availability of a generic equivalent of the Products, regulatory actions or other developments materially and adversely affecting the market for the Products, the Parties will discuss in good faith and mutually agree upon a commercially reasonable reduction to such forecasts.  With respect to any Forecast submitted by Purchaser hereunder, Purchaser may request an increase of no greater than [***] in the quantity of API forecast [***] and Noramco shall take commercially reasonable efforts to accommodate such request.

 

3.2.                             With respect to each Forecast (and any increase to such Forecast), [***]

 

3.3.                             Purchaser shall place monthly purchase orders for API with Noramco, each of which shall specify quantities in kilograms and a delivery date that is not less than [***], nor more than [***], from the date of Noramco’s receipt of such purchase order (each, a “ Purchase Order ”).  Subject to this Section 3.3 and Article 8, Noramco shall supply and deliver such quantities of API to Purchaser as set forth in each Purchase Order, provided that, unless Noramco otherwise agrees in its sole discretion, each Purchase Order shall be consistent with the quantities set forth in the applicable Forecast provided in accordance with Section 3.1 and the delivery date restrictions set forth in this Section 3.3.  Each Purchase Order must be submitted with a certificate of available Procurement Quota or a completed DEA Form 222 which evidences that Purchaser shall be able to take delivery of the API subject to the Purchase Order; provided , however , that Noramco, in its sole discretion, may agree to accept a Purchase Order which specifies the amounts of API that are contingent upon future receipt of Procurement Quota.  In the event that Noramco accepts any Purchase Order which specifies that all or a portion of API is contingent upon receipt of Procurement Quota, the supply and purchase thereof shall be subject to Article 8.

 

4.                                       CONSIDERATION FOR SUPPLY OF API

 

4.1.                             The price of API to be sold to Purchaser during the Initial Price Term shall be based on the annual volume of API ordered by Purchaser as set forth on Appendix C (the “ Supply Price ”).  For the avoidance of doubt [***]

 

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

 

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4.2.                             After the Initial Price Term, a reasonable increase in the Supply Price shall be mutually agreed upon by the Parties [***]  In the event a mutual agreement is not reached on the price increase, the Supply Price shall be [***]

 

4.3.                             In addition to the foregoing, at any time during the Term, Noramco shall be entitled to adjust the Supply Price in the event of increases to the cost of raw materials or fees of third party contractors incurred by Noramco as compared with such costs on the Effective Date; provided , however , that such adjustments to the Supply Price shall not take effect until Noramco and Purchaser discuss such adjustments in good faith.  Such Supply Price increases shall be applicable to any and all orders placed more than [***] after Noramco has notified Purchaser of the increase in writing.  Purchaser shall be entitled to request that an independent certified accountant verifies the accuracy of any such Supply Price increases.

 

4.4.                             Purchaser shall pay Noramco for all supplied quantities of API within [***] from the date of invoice, provided that, pending resolution of any disagreement under Article 6, Purchaser is not obligated for any payment payable with respect to API for which Purchaser has delivered a written objection pursuant to Article 6.

 

4.5.                             All payments payable for the purchase of API will be made by electronic transfer of United States Dollars to an account designated in writing by Noramco.

 

4.6.                             Noramco will not be obligated to honor orders or shipments to Purchaser should Purchaser’s account with Noramco fall greater than [***] in arrears.

 

4.7.                             In addition to the Supply Price for quantities of API delivered hereunder, Purchaser shall pay Noramco any and all governmental taxes, charges or duties of every kind (excluding any tax based upon Noramco’s net income) that Noramco may be required to collect or pay upon sale, transfer or shipment of API to Purchaser.

 

5.                                       SHIPMENT OF API

 

5.1.                             Noramco shall make deliveries of API to Purchaser or its designate [***].  Each shipment of API delivered to Purchaser hereunder shall be accompanied by an invoice for the quantity of API included in such shipment.

 

5.2.                             In the event that a Purchase Order is delivered where delivery of any API thereunder is contingent upon Purchaser securing Procurement Quota, Noramco may require cash or satisfactory security prior to accepting such Purchase Order or shipments or deliveries of API hereunder.  The election by Noramco to require such cash or security shall not affect the obligation of Purchaser to take and pay for the ordered API.  Purchaser shall pay all costs and expenses, including reasonable attorneys’ fees, incurred by Noramco in the collection of any sum payable by Purchaser to Noramco under this Agreement.  Noramco shall be entitled to interest on any overdue sum at the maximum rate allowed by applicable law.

 

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

 

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6.                                       INSPECTION AND REJECTION

 

6.1.                             All API delivered to Purchaser hereunder may be inspected by Purchaser and rejected if the API does not meet the Specifications or has not been manufactured in accordance with cGMP(s) (any such API, “ Nonconforming API ”).  API will be deemed accepted if Noramco does not receive a written notice from Purchaser setting forth in reasonable detail the claimed visible nonconformity within [***] after delivery to Purchaser of such API or the claimed non-visible nonconformity within [***] after Purchaser’s discovery of such non-visible nonconformity, provided, however, in no event shall any API be rejected based on nonconformity less than [***] prior to its expiration date.

 

6.2.                             Upon receipt of a written notice that any API delivered hereunder is Nonconforming API within the time period specified in Section 6.1, Noramco will have [***] to inspect the allegedly Nonconforming API and make a reasonable assessment of the alleged nonconformance.  At Noramco’s request, Purchaser must promptly supply samples of the allegedly Nonconforming API or some other evidence of nonconformity that Noramco may reasonably specify.

 

6.3.                             If Noramco disagrees with Purchaser’s determination that API delivered hereunder is Nonconforming API, Noramco shall promptly notify Purchaser and, if the Parties are unable to resolve such disagreement within a [***] period, such disagreement will be investigated in accordance with the Quality Agreement.  If the Parties cannot agree after such investigation whether such API is in fact Nonconforming API, (a) if Purchaser alleges that such API does not meet the Specifications, then samples of such API will be submitted to a qualified independent laboratory mutually agreed to by Noramco and Purchaser for testing and such laboratory will use the test methods contained in the applicable Specifications or (b) if Purchaser alleges that such API has not been manufactured in accordance with cGMP(s), then such disagreement shall be referred to a mutually agreed upon third party expert for resolution which shall include root cause investigation, independent expert assessment, independent third party testing and replacement of API.  The determination of such laboratory or third party expert with respect to all or part of such API will be final and binding on the Parties, absent manifest error.  The fees and expenses of the laboratory or third party expert incurred in making such determination will be paid by Noramco, if the determination is made against Noramco or by Purchaser, if the determination is made against Purchaser.

 

6.4.                             If the Parties agree or there is a determination under Section 6.3 that any API delivered hereunder is Nonconforming API, Noramco, at its sole cost and expense and as Purchaser’s sole remedy shall, subject to Sections 10.4 and 10.5, promptly replace such Nonconforming API and reimburse Purchaser [***].  Nonconforming API will be returned to Noramco at its expense.

 

6.5                                During the Term and for [***] thereafter, Purchaser shall have the right, upon at least [***] notice, to inspect, during normal business hours, those areas of Noramco’s production facilities where API is manufactured, handled, packaged and stored, any facility or location where API is tensed, and to audit the records described in this Agreement.

 

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

 

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7.                                       PRODUCT COMPLAINTS, ADVERSE EXPERIENCES AND RECALLS

 

7.1.                             During the Term, Noramco shall assist Purchaser with any necessary investigation arising from customer complaints relating to Product in accordance with the Quality Agreement.  Without in any manner limiting the foregoing, each of Purchaser and Noramco shall comply with FDA requirements for complaint handling. Purchaser shall maintain a system for monitoring, investigating, and following up on adverse event reports received by it involving Product(s), and shall provide prompt notice to Noramco of any Product complaints, including, but not limited to, information concerning adverse drug events that are required to be reported to FDA, side effects, injury, toxicity, or sensitivity reaction in those instances where the adverse drug event can be attributed specifically to the API.

 

7.2.                             Each Party shall notify the other Party of any regulatory action or other action concerning the safety of the API in accordance with the Quality Agreement, including but not limited to FDA inspection reports, warning letters or import alerts.

 

7.3.                             In the event of a recall of Product that does not result from the breach of Noramco’s obligations under Section 2.4 to manufacture API in accordance with cGMP and the Specifications, as between Noramco and Purchaser, [***]  For the purposes of this Section 7.3, the direct expenses of a recall shall include only [***]

 

8.                                       MANUFACTURING INTERRUPTIONS, QUOTA RESTRICTIONS AND SHORTAGES

 

8.1.                             Manufacturing Interruptions .  Purchaser acknowledges that the day-to-day manufacturing operation of the facilities used by Noramco to produce API may be subject to interruptions, fluctuations, slow-downs, suspensions and reductions, due to a variety of reasons in the ordinary course of business (“ Manufacturing Interruptions ”).  If Noramco believes that a Manufacturing Interruption is reasonably likely to result in a material reduction of API available to be delivered to Purchaser, Noramco shall provide notice to Purchaser of, and consult with Purchaser about, such Manufacturing Interruption prior to or as soon as reasonably possible after the commencement of such Manufacturing Interruption.  After the termination of any Manufacturing Interruption that results in a material reduction of API, Noramco shall promptly communicate to Purchaser regarding the termination of such Manufacturing Interruption and the reason therefor, as well as any actions taken or planned to be taken to prevent a repeat event.

 

8.2.                             Manufacturing Quota Restrictions .  Purchaser further acknowledges that the production and supply of API is contingent upon DEA rules, orders or directives related to the Manufacturing Quota that may limit or restrict the manufacture or supply of API by Noramco to Noramco’s customers (“ Manufacturing Quota Restrictions ”).  If Noramco believes that a Manufacturing Quota Restriction is reasonably likely to result in a material reduction or suspension of the delivery of API to Purchaser, Noramco shall promptly consult with Purchaser to coordinate with respect to their respective obligations in accordance with Sections 8.4 and 8.5.

 

8.3.                             Procurement Quota Restrictions .  It is the sole responsibility of Purchaser, and Purchaser shall use commercially reasonable efforts, to obtain Procurement Quota for API, provided that Noramco shall reasonably cooperate with Purchaser to assist Purchaser in obtaining Procurement Quota.  Noramco acknowledges that Purchaser’s receipt of API manufactured by Noramco is contingent

 

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

 

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upon DEA rules, orders or directives related to the Procurement Quota that may limit or restrict Noramco’s customers from receiving API manufactured by Noramco (“ Procurement Quota Restrictions ”).  If Purchaser believes that a Procurement Quota Restriction is reasonably likely to result in Purchaser’s inability to take delivery of an API from Noramco in accordance with the delivery date set forth in a Purchase Order, Purchaser shall promptly consult with Noramco to coordinate with respect to their respective obligations in accordance with Section 8.4.

 

8.4.                             Failure to Obtain Quota .  Each Party shall use commercially reasonable efforts to prepare and plan for the supply and purchase of API(s) against Purchase Orders to be given in accordance with the Forecasts in anticipation of each Party receiving applicable quota from the DEA.  In the event that a Party does not obtain the necessary Manufacturing Quota or Procurement Quota, as the case may be, to allow it to perform its obligations under this Agreement, such Party shall promptly inform the other Party in writing.  In the event that there is not sufficient Manufacturing Quota or Procurement Quota with respect to an outstanding Purchase Order, such Purchase Order shall nonetheless remain valid and binding upon the Parties, provided that the Purchase Order delivery date will be adjusted by the Parties for a period not to exceed [***] so as to permit receipt of the necessary Manufacturing Quota or Procurement Quota, as the case may be.  In the event that Manufacturing Quota is not received by Noramco within [***] of the original delivery date set forth in a Purchase Order, then such Purchase Order may be, but is not required to be, cancelled by Purchaser by written notice to Noramco, which cancellation shall be Purchaser’s sole and exclusive remedy for the applicable Manufacturing Quota Restriction.  In the event that Purchaser does not obtain Procurement Quota within [***] of the original delivery date set forth in a Purchase Order, [***]

 

8.5.                             Allocation Among Customers and Cooperation .  Purchaser recognizes that, due to Manufacturing Interruptions or Manufacturing Quota Restrictions, Noramco may produce less API in any given time period than anticipated, and that Noramco may, at its discretion, allocate its available supply of API among its customers, itself, and its Affiliates [***].  Notwithstanding the above, Noramco shall (a) use commercially reasonable efforts to minimize interruptions in the supply of API and (b) use commercially reasonable efforts to coordinate with Purchaser to mitigate against the consequences of any shortages related to Manufacturing Interruptions or Manufacturing Quota Restrictions.

 

8.6.                             No Liability for Manufacturing Quota Restrictions .  Subject to Noramco’s compliance with its obligations set forth in this Article 8, Noramco shall not be liable to Purchaser for any damage, inconvenience, or any other consequences that may arise from Manufacturing Quota Restrictions.

 

9.                                       WARRANTIES; DISCLAIMER

 

9.1.                             Noramco hereby represents, warrants and covenants to Purchaser that:

 

9.1.1.                   it has the corporate authority to enter into this Agreement and to perform its obligations hereunder;

 

9.1.2.                   it is not subject to any legal, contractual or regulatory restriction, limitation or conditions that may affect adversely its ability to perform its obligations hereunder; and

 

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

 

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9.1.3.                   all API sold to Purchaser by Noramco pursuant to this Agreement shall meet all Specifications.

 

9.2.                             Purchaser hereby represents, warrants and covenants to Noramco that:

 

9.2.1.                   it has the corporate authority to enter into this Agreement and to perform its obligations hereunder; and

 

9.2.2.                   it is not subject to any legal, contractual or regulatory restriction, limitation or conditions that may affect adversely its ability to perform its obligations hereunder.

 

9.3.                             THE PARTIES AGREE THAT, EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 9, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND AND THE LIMITED REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS ARTICLE 9 ARE THE SOLE REPRESENTATIONS AND WARRANTIES WITH RESPECT TO API AND ARE MADE EXPRESSLY IN LIEU OF, AND EXCLUDE, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY PATENT RIGHTS AND ALL OTHER EXPRESS OR IMPLIED WARRANTIES PROVIDED BY APPLICABLE LAW, INCLUDING THE UNIFORM COMMERCIAL CODE AND THE UN CONVENTION ON CONTRACTS FOR THE INTERNATIONAL SALE OF GOODS.

 

10.                                INDEMNIFICATION; CONSEQUENTIAL DAMAGES AND LIMITATION OF LIABILITY

 

10.1.                      Purchaser shall indemnify, defend, save and hold Noramco and each of its Affiliates and their respective officers, directors, employees and agents (each a “ Noramco Indemnitee ”) harmless from and against any liability, loss, costs, damage and/or expense, including reasonable attorneys, experts and consultants fees and disbursements (“ Loss or Losses ”) in connection with any and all suits, investigations (governmental or otherwise), claims, proceedings or demands initiated or filed by a third party (each an “ Action ”) against a Noramco Indemnitee, to the extent resulting from or arising out of (a) any breach of any representation, warranty or covenant hereunder by any Purchaser Indemnitee; (b) a Purchaser Indemnitee’s negligence or willful misconduct; or (c) Purchaser’s, manufacture, use or sale of Product, in each case ((a), (b) and (c)), except to the extent that such Losses result from or arise out of a Noramco Indemnitee’s negligence or willful misconduct.

 

10.2.                      Noramco shall indemnify, defend, save and hold Purchaser and each of its Affiliates and their respective officers, directors, employees and agents (each a “ Purchaser Indemnitee ”) harmless from and against Loss or Losses in connection with any Action against a Purchaser Indemnitee, to the extent resulting from or arising out of (a) any breach of any representation, warranty or covenant hereunder by a Noramco Indemnitee or (b) a Noramco Indemnitee’s negligence or willful misconduct, in each case ((a) and (b)), except to the extent that such Losses result from or arise out of a Purchaser Indemnitee’s negligence or willful misconduct.

 

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

 

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10.3.                      Upon becoming aware of an Action subject to indemnification under Section 10.1 or 10.2, the Party entitled to indemnification (the “ Indemnified Party ”) shall give prompt written notice thereof to the other Party (the “ Indemnifying Party ”), which notice shall include reasonable details of the nature of the Action and the basis of the indemnity claim, and shall further expressly state that the Indemnified Party it is seeking indemnity pursuant to this Agreement.  For the avoidance of doubt, and without prejudice to the Indemnified Party’s obligation to give prompt written notice, an Indemnifying Party’s knowledge of events or circumstances pursuant to which an Indemnified Party might seek indemnification, including correspondence between the Parties regarding a matter for which indemnity is not expressly sought, shall not constitute the notice required by this provision, and any attorneys, experts or consultant fees or expenses incurred by an Indemnified Party prior to proper notice shall be the sole responsibility of such Party; provided , however , that failure to provide timely notice shall not bar any indemnification claim unless the Indemnifying Party shall be, or has been, materially prejudiced by failure to receive such timely notice.   The Indemnifying Party will have the right, at its expense and with counsel of its choice, to defend, contest, or otherwise protect against any Action. The Indemnified Party will also have the right, but not the obligation, to participate, at its own expense, in the defense thereof with counsel of its choice. The Indemnified Party shall cooperate to the extent reasonably necessary to assist the Indemnifying Party in defending, contesting or otherwise protesting against any Action, provided that the reasonable cost in doing so shall be paid for by the Indemnifying Party.  If the Indemnifying Party fails, within thirty (30) days after receipt of notice of an Action from the Indemnified Party, to (a) notify the Indemnified Party of its intent to defend such Action or (ii) defend, contest or otherwise protect against such Action or diligently continue to provide defense against such Action after undertaking to do so, then the Indemnified Party will have the right. upon ten (10) days’ prior written notice to the Indemnifying Party, to defend, settle and satisfy such Action and recover the costs of the same from the Indemnifying Party.  No Action may be settled other than by the Party defending the same, and then only with the consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that the Indemnifying Party shall have no obligation to obtain the consent of the Indemnified Party to settle an Action if such settlement does not impose on the Indemnified Party any liability or obligation.

 

10.4.                      EXCEPT TO THE EXTENT INCLUDED IN LOSSES RESULTING FROM OR ARISING OUT OF AN ACTION FOR WHICH ONE PARTY IS OBLIGATED TO INDEMNIFY THE OTHER PARTY (OR AN INDEMNITEE OF SUCH OTHER PARTY) PURSUANT TO THIS ARTICLE 10 OR ANY BREACH OF ARTICLE 11, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS OR LOSS OF OPPORTUNITY), OR LOST PROFITS EVEN IF DESIGNATED DIRECT DAMAGES, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.

 

10.5.                      Noramco’s maximum liability to Purchaser in any calendar year under this Agreement, including its indemnity obligations, shall not exceed the greater of (a) ten million dollars ($10,000,000) or (b) the total amount paid by Purchaser to Noramco under this Agreement for the prior completed twelve (12) month period.

 

11.                                CONFIDENTIALITY

 

11.1.                      Each Party agrees that it and its Affiliates (a) will not disclose any Confidential Information of the other Party to any third party at any time during the Term without the prior written consent of such other Party; (b) will not make use of any Confidential Information of the other Party for any purpose other than the performance of its obligations under this Agreement and (iii) will use all reasonable efforts to prevent unauthorized publication or disclosure by any Person of Confidential Information of the other Party.  Notwithstanding the foregoing, (i) a Party may disclose Confidential Information of the other Party to its Affiliates, and to its and their directors, employees, consultants, and agents, in each case who, in such disclosing Party’s sole determination, have a specific need to know such Confidential Information and who are bound by obligations of confidentiality and restriction on use no less restrictive than those set forth in this Article 11 and (ii) Noramco may disclose Confidential Information of Purchaser in accordance with Section 14.2.

 

11.2.                      Notwithstanding the foregoing, a Party may, upon reasonable prior written notice to the other Party if permitted, disclose Confidential Information of the other Party to the extent necessary to comply with law or court order, provided that such first Party provides prior written notice of such disclosure to the other Party if permitted and takes all reasonable actions to avoid or minimize the degree of such disclosure.

 

11.3.                      All Confidential Information in any form must be returned to the Party who disclosed the Confidential Information within thirty (30) days of the termination or expiration of this Agreement, provided that the receiving Party may retain one copy of Confidential Information disclosed to it hereunder as a record of such receiving Party’s ongoing confidentiality obligations under this Agreement, which copy shall either be returned to the Party who disclosed the Confidential Information within thirty (30) days after the [***] period referred

 

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

 

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to in Section 11.4 or, if not returned, shall continue to be subject to the confidentiality provisions of this Agreement indefinitely.

 

11.4.                      The confidentiality and non-use obligations of this Agreement shall remain in effect during the Term and for a period of [***] thereafter.

 

11.5.                      Confidential Information ” means [***]  Notwithstanding the foregoing, Confidential Information does not include information, data or know-how that the receiving Party can show:

 

(a)                                  was in the public domain at the time of the disclosure to the receiving Party, or thereafter became part of the public domain without any fault of the receiving Party;

 

(b)                                  rightfully was in its possession prior to the disclosure by the disclosing Party;

 

(c)                                   was lawfully obtained from a third party who had the right to make such disclosure, as evidenced by written records; or

 

(d)                                  was developed by the receiving Party independently of that disclosure, as evidenced by written records, by individuals who did not rely on or otherwise use Confidential Information.

 

12.                                IN TELLECTUAL PROPERTY

 

12.1.                      Noramco hereby grants to Purchaser during the Term a non-exclusive, royalty-free license under the API Manufacturing Patents to (a) use API supplied by Noramco to Purchaser hereunder to make or have made Products for distribution in the United States and (b) offer for sale, sell, commercialize and import Products containing API supplied by Noramco to Purchaser hereunder in the United States.

 

12.2.                      If (a) Noramco’s process of manufacture of API becomes the subject of a written third party claim for infringement of such third party’s U.S. patent rights and (b) Noramco reasonably determines in [***] that such process is reasonably likely to infringe such third party’s U.S. patent rights (an “Infringement Claim”), Noramco may [***]

 

12.3.                      All rights to and interests in Noramco’s and its Affiliates’ intellectual property, including any improvements thereto, will remain solely with Noramco and its Affiliates and no right or interest therein is transferred or granted to Purchaser under this Agreement, except as expressly provided for herein or in the Asset Purchase Agreement.  Except as otherwise set forth in the Asset Purchase Agreement, Purchaser agrees that it does not acquire, pursuant to this Agreement, any license or any other right to Noramco’s or its Affiliate’s intellectual property or improvements thereto, except as expressly provided for herein.

 

12.4.                      [***]

 

13.                                TERM, RENEWAL AND TERMINATION

 

13.1.                      The initial term of this Agreement shall commence on the Effective Date and shall continue until the seventh (7 th ) anniversary of the Effective Date, unless sooner terminated as

 

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

 

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expressly provided for in this Agreement (the “ Initial Term ”).  Thereafter, this Agreement shall be automatically renewed for additional terms of one (1) year (each, a “ Renewal Term ” and all Renewal Terms together with the Initial Term, the “ Term ”).  If an alternative or replacement source of API has been qualified by Purchaser to supply API for Commercial use, either party may notify the other Party in writing no later than six (6) months prior to the end of the then-current Initial Term or Renewal Term, as the case may be, that it does not wish to renew the Agreement.  If [***], Noramco may notify Purchaser in writing no later than [***] prior to the end of the then-current Initial Term or Renewal Term, as the case may be, that it does not to wish to renew the Agreement.

 

13.2.                      Purchaser may terminate this Agreement without cause immediately following [***] prior written notice to Noramco; provided, however, that the effective date of such termination shall in no event be earlier than the [***] of the Effective Date.

 

13.3.                      This Agreement may be terminated by either Party by giving written notice to the other Party if the other Party (the “ Breaching Party ”) is in material breach or default of any of its obligations hereunder (including any payment obligations) as follows: (a) the terminating Party must send written notice of the material breach or material default to the Breaching Party; and (b) the termination shall become effective sixty (60) days after receipt of such written notice by the Breaching Party unless either (i) the Breaching Party has cured such material breach or default prior to the expiration of such sixty (60) day period or (ii) if such material breach or material default is not capable of being cured within such sixty (60) day period, the Breaching Party has commenced activities reasonably expected to cure such material breach or material default within such sixty (60) day period and thereafter uses diligent efforts to complete the cure as soon as practicable, provided that, if such material breach or material default is not cured within one hundred and twenty (120) days after receipt of such written notice by the Breaching Party, the termination shall become effective upon the expiration of such one hundred and twenty (120) day period.

 

13.4.                      Either Party may terminate this Agreement without prior notice to the other upon the occurrence of any of the following involving the other Party:

 

(a)                                  that other Party files a petition seeking an order for relief under the Federal Bankruptcy Code (Title 11 of the United States Code), as now or hereafter in effect, or under similar law (including laws in countries or jurisdictions other than the United States), or files a petition in bankruptcy or for reorganization or for an arrangement pursuant to any state bankruptcy law or any similar state or local law (including laws in countries or jurisdictions other than the United States); or

 

(b)                                  an involuntary case against the other Party as debtor is commenced by a petition under the Federal Bankruptcy Code (Title 11 of the United States Code), as now or hereafter in effect, or under similar law (including laws in countries or jurisdictions other than the United States), or a petition or answer proposing the adjudication of the other Party as a bankrupt or its reorganization pursuant to any state bankruptcy law or any similar state or local law (including laws in countries or jurisdictions other than the United States) is filed in any court and not dismissed, discharged or denied within sixty (60) days after the filing thereof; or

 

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

 

14



 

(c)                                   a custodian, receiver, United States Trustee, trustee or liquidator of the other Party or of all or substantially all of the other Party’s property is appointed in any proceedings brought by the other Party; or

 

(d)                                  a custodian, receiver, United States Trustee, trustee or liquidator is appointed in any proceedings brought against the other Party and is not be discharged within sixty (60) days after that appointment, or if the other Party consents to or acquiesces in such appointment; or

 

(e)                                   the other Party generally does not pay its debts as those debts become due, or makes an assignment for the benefit of creditors, or admits in writing its inability to pay its debts generally as they become due.

 

13.5.                      Any expiration or termination of this Agreement shall not release the Parties from liabilities or obligations accrued on or prior to the date of expiration or termination. The following provisions shall survive termination and/or expiration of this Agreement indefinitely or for such shorter period as is provided in such Articles or Sections, along with any other provisions of this Agreement that are necessary to interpret or give effect to any of the following provisions: (a) Sections 6.5, 8.6, 9.3 and 12.3; and (b) Articles 10 (Indemnification; Consequential Damages; Limitations of Liability), 11 (Confidentiality), 15 (Notices) ; 19 (Dispute Resolution); 23 (No Benefit to Third Parties), and 24 (Publicity).

 

14.                                INDEPENDENT CONTRACTORS; SUBCONTRACTORS

 

14.1.                      The status of the Parties under this Agreement is that of independent contractors.  Nothing is this Agreement may be construed as establishing a partnership or joint venture relationship between the Parties hereto.  No Party has the right to enter into any agreements on behalf of the other Party, nor may it represent to any Person that it has that right or authority.

 

14.2.                      Noramco may subcontract any or all of its obligations hereunder to any of its Affiliates without the approval of Purchaser or to any other third party approved by Purchaser (which approval shall not be unreasonably withheld), provided that Noramco shall remain fully responsible for performing such obligations in compliance with this Agreement and shall take reasonable measures to ensure that its subcontractors perform such obligations in compliance with this Agreement.  [***]  Notwithstanding anything in this Agreement to the contrary, Noramco shall be permitted to share Confidential Information of Purchaser with its permitted subcontractors, provided such subcontractor is bound by obligations of confidentiality and restriction on use no less restrictive than those set forth in Article 11.

 

15.                                NOTICES

 

All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed to have been duly given if delivered, addressed or telecopied to the address or telecopier number set forth below and shall be deemed to have been made:  (a) on the date of service, if served personally on the Party; (b) on the second business day after delivery to an overnight courier service, if first available delivery is indicated and paid for; (c) on the third business day after mailing, if mailed to the Party to whom notice is to be given, by first class mail, registered or certified, postage prepaid; or

 

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

 

15



 

(iv) on the date of transmission, if sent by telecopier and confirmation of transmittal is received by the transmitting Party.  Any Party may change its address for purposes of this Article by giving the other Party’s written notice of the new address in the manner set forth above.

 

If to Purchaser:

 

Depomed, Inc.

 

 

7999 Gateway Blvd., Suite 300

 

 

Newark, California 94560

 

 

Attention: Legal Department

 

 

Facsimile No.: 510-744-8001

 

 

 

If to Noramco:

 

Noramco, Inc.

 

 

500 Swedes Landing Road

Wilmington, Delaware 19801

Attention: Vice President Marketing & Business Development

Facsimile No.: 302-761-2913

 

16.                                FORCE MAJEURE

 

16.1.                      Neither Party will be liable for non-performance or delay in the fulfillment of its obligations under this Agreement if such non-performance or delay is occasioned by any cause beyond the reasonable control of Purchaser or Noramco, as the case may be, including acts of God, fire, flood, earthquakes, explosions, sabotage, strikes, or labor disturbances (regardless of the reasonableness of the demands of the labor force), civil commotion, riots, military invasions, wars, failure of utilities, failure of carriers, inability to obtain any required raw material, energy source, equipment, labor or transportation, at prices and on terms Noramco deems practicable from its usual sources of supply or any acts, restraints, requisitions, regulations, or directives issued by a competent government authority, including changes in law or regulation (“ Force Majeure Events ”); provided , however , a Force Majeure Event shall never excuse a Party from paying any sum of money owed under the terms of this Agreement.

 

16.2.                      In the event that either Party is prevented from discharging its obligations under this Agreement on account of a Force Majeure Event, that Party shall promptly notify the other Party, and shall nevertheless make reasonable, good faith efforts to discharge its obligations, even if in a partial or compromised manner.  In the event that a Force Majeure Event continues for a period of [***], the Party not claiming the Force Majeure Event will be entitled to terminate this Agreement forthwith, but without penalty or liability to the Party affected by the Force Majeure Event, on written notice to the Party claiming the Force Majeure Event, provided that such termination shall not affect any Party’s right to receive amounts which have accrued or became due prior to the termination.

 

16.3                         The Party affected by a Force Majeure Event shall use commercially reasonable efforts to limit the effects of a Force Majeure Event upon its performance of the Agreement and shall notify the other Party, immediately, of the cessation of the Force Majeure Event.

 

17.                                ENTIRE AGREEMENT; MODIFICATION

 

This Agreement, including the appendices hereto which are incorporated by reference, constitutes the entire agreement of the Parties with respect to its subject matter and supersedes all prior agreements, arrangements, dealings and writings between the Parties that relate to the matters covered herein.  Any terms and conditions of an invoice, acknowledgement or similar document provided by Noramco for

 

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

 

16



 

API, or any terms and conditions of Purchase Orders provided by Purchaser for API, which are inconsistent with or in addition to the terms of this Agreement shall be null and void.  This Agreement may not be amended or modified except in writing executed by the duly authorized representatives of both Parties.

 

18.                                WAIVER

 

No waiver of a breach or default hereunder will be considered valid unless written and signed by the Party granting such waiver, and no waiver will be deemed a waiver of any subsequent breach or default of the same or similar nature.

 

19.                                DISPUTE RESOLUTION

 

19.1.                      Any controversy or claim arising out of or relating to this Agreement, including any such controversy or claim involving any Affiliate of any Party (a “ Dispute ”), shall first be submitted to mediation according to the Commercial Mediation Procedures of the American Arbitration Association (“ AAA ”)  ( see www.adr.org).  Such mediation shall be attended on behalf of each Party for at least one session by a senior business person with authority to resolve the Dispute.  Any period of limitations that would otherwise expire between the initiation of mediation and its conclusion shall be extended until [***] days after the conclusion of the mediation.

 

19.2.                      Any Dispute that cannot be resolved by mediation within [***] days of notice by one Party to the other of the existence of a Dispute (unless the Parties agree to extend that period) shall be resolved by arbitration in accordance with the Commercial Arbitration Rules  of the AAA (“ AAA Rules ”; see www.adr.org) and the Federal Arbitration Act, 9 U.S.C. §1 et seq..  The arbitration shall be conducted in New Jersey, by one arbitrator appointed in accordance with the AAA Rules.

 

19.3.                      The arbitrator shall follow the ICDR Guidelines for Arbitrators Concerning Exchanges of Information in managing and ruling on requests for discovery.  The arbitrator, by accepting appointment, undertakes to exert her or his best efforts to conduct the process so as to issue an award within [***] of her or his appointment, but failure to meet that timetable shall not affect the validity of the award.

 

19.4.                      The arbitrator shall decide the Dispute in accordance with the substantive law of New Jersey.  The arbitrator may not award special, indirect, incidental, punitive or consequential damages (including loss of profits or loss of opportunity), or lost profits even if designated direct damages, nor may the arbitrator apply any multiplier to any award of actual damages, except as may be required by statute.  The award of the arbitrator may be entered in any court of competent jurisdiction.

 

20.                                SEVERABILITY

 

Should any part or provision of this Agreement be held unenforceable or in conflict with applicable law, the invalid or unenforceable part or provision will, so long as it does not go to the essence of this Agreement, be replaced with a revision that accomplishes, to the extent possible, the original

 

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

 

17



 

commercial purpose of that part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties hereto.

 

21.                                SUCCESSORS AND ASSIGNS

 

This Agreement may not be assigned or otherwise transferred by a Party without the prior written consent of the other Party; provided , however , that (i) either Party may, without such consent, but with notice to the other Party, assign this Agreement, in whole or in part: (a) in connection with the transfer or sale of all or substantially all of such Party’s assets or the line of business for the API (in the case of Noramco) or the Products (in the case of Purchaser); (b) to a successor entity or acquirer in the event of a sale, merger, consolidation, change of control or similar transaction of such Party; or (c) to any Affiliate of such Party (in that case, so long as such assigning Party remains fully liable for all of its obligations hereunder as a primary obligor); (ii) Purchaser may, without such consent, but with notice to Noramco, assign this Agreement (a) in connection with any transaction the primary purpose of which is to change the domicile of Purchaser or (b) to any lender of Purchaser or purchaser of securities used to finance the Transactions as collateral security to secure the obligations of any indebtedness of Purchaser; and (iii) in the event Noramco determines, in its sole discretion, that Noramco and its Affiliates will permanently discontinue all manufacture and supply of API, Seller shall notify Purchaser about the decision without delay and, thereafter, Noramco shall have the right to assign this Agreement in its entirety to [***].  Any permitted assignee will assume the rights and obligations of its assignor under this Agreement.  Any purported assignment in violation of this Section 21 will be void.

 

22.                                COUNTERPARTS

 

This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, and together shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered to the other Party, it being understood that both Parties need not sign the same counterpart.  This Agreement, following its execution, may be delivered via telecopier machine or other form of electronic delivery, which shall constitute delivery of an execution original for all purposes.

 

23.                                NO BENEFIT TO THIRD PARTIES

 

The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other Persons.

 

24.                                PUBLICITY

 

Neither Party may make any press release or public statement regarding the subject matter of this Agreement or the existence thereof or use the other Party’s or its Affiliates’ names, trademarks, logos, symbols or other image in any form of advertising, promotion or publicity without the prior written consent of the other Party, except to the extent that the press release or public statement may be required by applicable law.

 

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

 

18



 

25.                                INTERPRETATION

 

25.1.                      The words “hereof”, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

 

25.2.                      The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

 

25.3.                      The terms “U.S. Dollars” and “$” shall mean lawful currency of the United States of America.

 

25.4.                      The terms “include,” “includes” and “including” shall mean “including, without limitation.”

 

25.5.                      When a reference is made in this Agreement to an Article, a Section, an Exhibit or a Schedule, such reference shall be to an Article or a Section of, or an Exhibit or a Schedule to, this Agreement unless otherwise indicated.

 

25.6.                      Time periods based on a number of days 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, if applicable, by extending the period to the next business day following if the last day of the period is not a business day.

 

25.7.                      The term “United States” shall refer to the United States of America and its territories, including Puerto Rico.

 

[Remainder of Page is Intentionally Blank]

 

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

 

19



 

IN WITNESS WHEREOF, each of the Parties has executed this Agreement on the Effective Date.

 

 

  Depomed, Inc.

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

Name:

James A. Schoeneck

 

Title:

President and Chief Executive Officer

 

 

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

 

[Signature Page for API Supply Agreement]

 



 

Noramco, Inc.

 

 

 

 

 

By:

/s/ Matthew Martin

 

Name:

Matthew Martin

 

Title:

General Manager

 

 

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

 

[Signature Page for API Supply Agreement]

 



 

APPENDIX A

 

Products

 

[***](1)

 


(1) Two pages omitted and filed separately with the Commission.

 

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

 



 

APPENDIX B

 

Specifications

 

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

 



 

APPENDIX C

 

Commercial Supply Price

 

[***]

 

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

 



 

APPENDIX D

 

Finished Good Tapentadol Calculation

 

[***]

 

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

 


Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, James A. Schoeneck, certify that:

 

1.              I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q/A of Depomed, Inc.; and

 

2.              Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.

 

December 18, 2015

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

 

James A. Schoeneck

 

 

Chief Executive Officer

 


Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, August J. Moretti, certify that:

 

1.              I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q/A of Depomed, Inc.; and

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.

 

December 18, 2015

 

 

 

 

 

 

By:

/s/ August J. Moretti

 

 

August J. Moretti

 

 

Chief Financial Officer