Document:

EX-10.1

 Exhibit 10.1 

EXECUTION COPY 
 AMENDMENT
NO. 1 TO CREDIT AGREEMENT 
 THIS AMENDMENT NO. 1 TO CREDIT AGREEMENT (the “Amendment”),
dated as of March 9, 2016, is made by and among NUVASIVE, INC., a Delaware corporation (the “Borrower”), the other Loan Parties (as defined in the Credit Agreement (as defined below)) signatory hereto, BANK OF AMERICA,
N.A., in its capacity as administrative agent for the Lenders (as defined in the Credit Agreement) (in such capacity, the “Administrative Agent”), and as Swingline Lender and L/C Issuer, and each of the Lenders signatory hereto.
Each capitalized term used and not otherwise defined in this Amendment has the definition specified in the Credit Agreement. 
 W I T N
E S S E T H: 
 WHEREAS, the Borrower, the Administrative Agent and the Lenders have entered into that
certain Credit Agreement dated as of February 8, 2016 (as hereby amended and as from time to time hereafter further amended, modified, supplemented, restated, or amended and restated, the “Credit Agreement”), pursuant to which the
Lenders have made available to the Borrower a revolving credit facility; 
 WHEREAS, the Borrower and the other Loan
Parties have requested that the Credit Agreement be amended as set forth herein; 
 WHEREAS, the Administrative Agent
and certain of the Lenders (representing the Required Lenders) are willing to make such amendments on the terms and conditions contained in this Amendment; and 

NOW, THEREFORE, in consideration of the premises and further valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties hereto agree as follows: 
 1. Amendments to Credit Agreement. Subject
to the terms and conditions set forth herein, the Credit Agreement is hereby amended as follows: 
 (a) The definition of
“Permitted Convertible Note Refinancing” set forth in Section 1.01 of the Credit Agreement is amended in its entirety, so that as amended the definition of “Permitted Convertible Note Refinancing” shall read
as follows: 
 “‘Permitted Convertible Note Refinancing’ means Indebtedness constituting a
refinancing or extension of the Convertible Notes that (a) does not have a maturity date prior to the Maturity Date or require any payment of principal in respect thereof in any manner materially different from the repayment requirements set forth
in the Convertible Notes, (b) does not require or permit any cash payment of interest in respect thereof at a rate in excess of 3.0% per annum, (c) is not supported by guaranties that are more favorable than the guaranties supporting the
Obligations, (d) does not require representations, warranties, covenants or events of default that are more restrictive, taken as a whole, than those set forth herein, (e) does not contain a cross-default to any Loan Document (other than the
occurrence of an Event of Default under Sections 8.01(a), to 

 
the extent such Event of Default is not discharged, cured, rescinded or annulled within a period of thirty (30) days after notice of its occurrence) and (f) is unsecured.” 

(b) Section 7.02(f) of the Credit Agreement is amended in its entirety, so that as amended Section 7.02(f) shall
read as follows: 
 “(i) the unsecured Convertible Notes outstanding on the date hereof and listed on
Schedule 7.02(f) to the Disclosure Letter and any Permitted Convertible Note Refinancing thereof, and (ii) unsecured Indebtedness substantially in the form of the Convertible Notes not to exceed $400,000,000 in the aggregate at any time outstanding
(which aggregate amount shall be reduced to $250,000,000 on July 14, 2017 (or such earlier date as shall be selected by the Borrower)) and any Permitted Convertible Note Refinancing thereof; provided, that, with respect to this clause (f), as
part of the consummation of a Permitted Convertible Note Refinancing or a repayment of a Convertible Note, the aggregate principal amount of such Indebtedness shall be permitted to be greater than the amounts set forth in this clause (f) for a
period of not more than three (3) Business Days subsequent to the refinancing or repayment of such Indebtedness and by an amount not greater than required to consummate such refinancing or repayment;” 

(c) Section 7.06(j) of the Credit Agreement is amended in its entirety, so that as amended Section 7.06(j) shall
read as follows: 
 “Loan Parties may (i) repurchase or repay any Convertible Notes and Permitted
Convertible Notes Refinancings (x) that the Loan Parties are required to repurchase or repay in accordance with the applicable Convertible Indebtedness Documents or the documents evidencing the Permitted Convertible Notes Refinancings and (y) in
connection with a Permitted Convertible Note Refinancing, as the case may be, and (ii) make Restricted Payments in respect of any Swap Contracts existing as of the date hereof or entered into in connection with any Permitted Convertible Notes
Refinancing; and” 
 2. Effectiveness; Conditions Precedent. The effectiveness of this Amendment and the
amendments provided in Section 1 are subject to the satisfaction of the following conditions precedent: 
 (a) the
Administrative Agent shall have received each of the following documents or instruments in form and substance reasonably acceptable to the Administrative Agent: 

(i) original counterparts of this Amendment, duly executed by the Borrower, the other Loan Parties, the
Administrative Agent, and the Required Lenders, together with all schedules thereto duly completed; and 

(ii) such other documents, instruments, opinions, certifications, undertakings, further assurances and other
matters as the Administrative Agent shall reasonably request; 
 (b) all fees and expenses payable to the Administrative
Agent and the Lenders (including the fees and expenses of counsel to the Administrative Agent) due and payable shall 

  
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have been paid in full (without prejudice to final settling of accounts for such fees and expenses). 

3. Consent of the Loan Parties. Each Loan Party hereby consents, acknowledges and agrees to the amendments set
forth herein and hereby confirms and ratifies in all respects the Loan Documents to which it is a party (including without limitation the continuation of payment and performance obligations of such Loan Party and the effectiveness and priority of
any Liens granted thereunder, in each case upon and after the effectiveness of this Amendment and the amendments contemplated hereby) and the enforceability of such Loan Documents against such Loan Party in accordance with its terms. 

4. Representations and Warranties. In order to induce the Administrative Agent and the Lenders to enter into this
Amendment, the Borrower and each other Loan Party represents and warrants to the Administrative Agent as follows: 
 (a) At
the time of and immediately after giving effect to this Amendment, the representations and warranties made by each of the Borrower and each other Loan Party in Article V of the Credit Agreement, and in each of the other Loan Documents to
which it is a party, are true and correct on and as of the date hereof, except to the extent that such representations and warranties expressly relate to an earlier date, in which case such representations and warranties are true and correct as of
such earlier date; 
 (b) No Default or Event of Default has occurred and is continuing or will exist after giving effect to
this Amendment; 
 (c) Since the date of the most recent financial reports of the Borrower delivered pursuant to Section
6.01 of the Credit Agreement, no act, event, condition or circumstance has occurred or arisen which, singly or in the aggregate with one or more other acts, events, occurrences or conditions (whenever occurring or arising), has had or could
reasonably be expected to have a Material Adverse Effect; and 
 (d) This Amendment has been duly authorized, executed and
delivered by the Borrower and each other Loan Party and constitutes the legal, valid and binding obligations of such Loan Party enforceable against such Loan Party in accordance with its terms, subject to effect of any applicable bankruptcy,
insolvency, reorganization, moratorium or other similar laws affecting creditors’ rights generally and subject to the effect of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or
at law). 
 5. Entire Agreement. This Amendment, together with the Loan Documents (collectively, the
“Relevant Documents”), sets forth the entire understanding and agreement of the parties hereto in relation to the subject matter hereof and supersedes any prior negotiations and agreements among the parties relating to such subject
matter. No promise, condition, representation or warranty, express or implied, not set forth in the Relevant Documents shall bind any party hereto, and no such party has relied on any such promise, condition, representation or warranty. Each of the
parties hereto acknowledges that, except as otherwise expressly stated in the Relevant Documents, no representations, warranties or commitments, express or implied, have been made by any party to any other party in relation to the subject

  
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matter hereof or thereof. None of the terms or conditions of this Amendment may be changed, modified, waived or canceled orally or otherwise, except in writing and in accordance with
Section 11.01 of the Credit Agreement. 
 6. Full Force and Effect of Credit Agreement. Except as hereby
specifically amended, modified or supplemented, the Credit Agreement and all other Loan Documents are hereby confirmed and ratified in all respects and shall be and remain in full force and effect according to their respective terms. The
execution, delivery and effectiveness of this Amendment shall not, except as expressly provided herein, operate as a waiver of any right, power or remedy of any Lender or the Administrative Agent under any of the Loan Documents, nor constitute a
waiver of any provision of any of the Loan Documents. On and after the effectiveness of this Amendment, this Amendment shall for all purposes constitute a Loan Document. 

7. Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed an
original as against any party whose signature appears thereon, and all of which shall together constitute one and the same instrument. Delivery of an executed counterpart of a signature page of this Amendment by telecopy, facsimile or other
electronic transmission (including .pdf) shall be effective as delivery of a manually executed counterpart of this Amendment. 

8. Governing Law. This Amendment 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 amendment shall in all respects be governed by, and construed in accordance with, the laws of the State of New York applicable to contracts executed and performed entirely within such
State, and shall be further subject to the provisions of Sections 11.14 and 11.15 of the Credit Agreement. 

9. Enforceability. Should any one or more of the provisions of this Amendment be determined to be illegal or
unenforceable as to one or more of the parties hereto, all other provisions nevertheless shall remain effective and binding on the parties hereto. 

10. References. From and after the date hereof, all references in the Credit Agreement and any of the other Loan
Documents to the “Credit Agreement” shall mean the Credit Agreement, as amended hereby and as from time to time hereafter further amended, modified, supplemented, restated or amended and restated. 

11. Successors and Assigns. This Amendment shall be binding upon and inure to the benefit of the Borrower, each
other Loan Party, the Administrative Agent, each Lender and their respective successors and assignees to the extent such assignees are permitted assignees as provided in Section 11.06 of the Credit Agreement. 

[Signature pages follow.] 

  
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 IN WITNESS WHEREOF, the parties hereto have caused this Amendment
Agreement to be duly executed by their duly authorized officers, all as of the day and year first above written. 
  

							
	BORROWER:	 		 	NUVASIVE, INC.
				
		 		 	 By:
	 	 /s/ Jereme Sylvain

		 		 	 Name:
	 	 Jereme Sylvain

		 		 	 Title:
	 	 VP, Corporate Controller

  

							
	 GUARANTOR:
	 		 	IMPULSE MONITORING, INC.
				
		 		 	 By:
	 	 /s/ Jereme Sylvain

		 		 	 Name:
	 	 Jereme Sylvain

		 		 	 Title:
	 	 VP, Corporate Controller

 NUVASIVE, INC. 

AMENDMENT NO. 1 TO CREDIT AGREEMENT 

 
			
	BANK OF AMERICA, N.A., as Administrative Agent 
		
	 By:
	 	 /s/ Tiffany Shin

	 Name:
	 	 Tiffany Shin

	 Title:
	 	 Assistant Vice President

 NUVASIVE, INC. 

AMENDMENT NO. 1 TO CREDIT AGREEMENT 

 
			
	 BANK OF AMERICA, N.A., as a Lender, L/C Issuer and

Swing Line Lender

		
	 By:
	 	 /s/ John C. Plecque

	 Name:
	 	 John C. Plecque

	 Title:
	 	 Senior Vice President

 NUVASIVE, INC. 

AMENDMENT NO. 1 TO CREDIT AGREEMENTExhibit 10.36

 

CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS DENOTE OMISSIONS.

 

EXECUTION COPY

 

SETTLEMENT AGREEMENT

 

BY AND BETWEEN

 

SUPERNUS PHARMACEUTICALS, INC.

 

AND

 

PAR PHARMACEUTICAL COMPANIES, INC.

 

PAR PHARMACEUTICAL, INC.

 

DATED AS OF OCTOBER 14, 2015

 

 

THIS SETTLEMENT AGREEMENT, (this “Settlement Agreement”) is entered into as of October 14, 2015 (the “Effective Date”) by and between, Supernus Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having offices located at 1550 East Gude Drive, Rockville, Maryland 20850, (“Supernus”), on the one hand, and Par Pharmaceutical Companies, Inc., a corporation organized and existing under the laws of Delaware, having offices located at One Ram Ridge Road, Chestnut Ridge, NY 10977 (“Par Cos.”), and Par Pharmaceutical, Inc., a corporation organized and existing under the laws of Delaware, having offices located at One Ram Ridge Road, Chestnut Ridge, New York 10977 (“Par Inc.” and together with Par Cos., “Par”), on the other hand.  Supernus and Par are collectively referred to herein as the “Parties,” or each individually as a “Party.”

 

R E C I T A L S:

 

WHEREAS, Supernus is the owner of New Drug Application No.  201635, which was approved by the Food and Drug Administration (“FDA”) for the manufacture and sale of an extended release topiramate oral capsule product, which Supernus sells under the trade name Trokendi XR®;

 

WHEREAS, Par Inc. submitted Abbreviated New Drug Application No.  205976 (together with any amendments, or supplements thereto, the “Par ANDA”) to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C.  §355(j)) seeking approval to engage in the manufacture, use, sale, offer for sale, or importation of an extended release topiramate oral capsule product that is the subject of the Par ANDA (the “Par Product”);

 

WHEREAS, the filing of the Par ANDA included a “paragraph IV certification” seeking approval to engage in the manufacture, use and sale of the Par Product prior to the expiration of United States Patent Nos. 8,298,576 (the “‘576 Patent”), 8,298,580 (the “‘580 Patent”), 8,663,683 (the “‘683 Patent”), 8,877,248 (the “‘248 patent”), 8,889,191 (the “‘191 Patent”), and 8,992,989 (the “‘989 Patent,” and together with the ‘576 Patent, the ‘580 Patent, the ‘683 Patent, the ‘248 Patent, and the ‘191 Patent, the “Litigated Patents”);

 

WHEREAS, Supernus has prosecuted, and Par has defended, an action for patent infringement in the United States District Court for the District of New Jersey (the “Court”) regarding the Par ANDA and the Par Product, which action is captioned Supernus Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc., et. al., (Civil Action No.  2:15-cv- 00326-SDW-SCM) (the “Pending Litigation”);

 

WHEREAS, Supernus and Par wish to settle the Pending Litigation and have reached an agreement, encompassing the terms and conditions set forth in this Settlement Agreement together with a License Agreement (the “License Agreement,” attached hereto as Exhibit A) and an agreed Judgment and Order of Permanent Injunction with regard to the Pending Litigation (the “Consent Judgment,” attached hereto as Exhibit B) (with the Settlement Agreement, the License Agreement, and the Consent Judgment being collectively referred to as the “Settlement Documents”);

 

 

WHEREAS, neither Supernus nor Par have received any consideration from the other for their entry into this Settlement Agreement other than that which is set forth in the Settlement Documents; and

 

WHEREAS, the Settlement Documents constitute Par’s and Supernus’ best independent judgment as to the most convenient, effective and expeditious way to mutually settle all disputes that have arisen associated with the Par ANDA.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements described herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.             Capitalized terms used, but not defined herein, shall have the meanings ascribed to them in the License Agreement.

 

2.             The Parties consent to the jurisdiction of the Court for the purposes of the settlement of the Pending Litigation.

 

3.             The Parties agree that the Court has jurisdiction over the Pending Litigation and over Supernus and Par, and that venue is proper in the District of New Jersey.

 

4.             Par admits that the Litigated Patents, and all the claims contained therein, were infringed by the filing of the Par ANDA and, absent a license from Supernus, would be infringed by the manufacture, use, sale, offer for sale, or importation of the Par Product in the Territory.  Supernus acknowledges, and Par avers, that the foregoing admission shall have no estoppel effect whatsoever in any proceeding the subject matter of which is not the Par Product.

 

5.             Par admits that the Litigated Patents, and all the claims contained therein, are valid and enforceable.  Supernus acknowledges, and Par avers, that the foregoing admission shall have no estoppel effect whatsoever in any proceeding the subject matter of which is not the Par Product.

 

6.             Par agrees that except as is otherwise expressly provided for in the License Agreement, it shall not manufacture, use, sell, offer for sale, or import, directly or indirectly, the Par Product.

 

7.             Par shall not assist a Third Party to manufacture, use, sell, offer for sale, or import, directly or indirectly, a Generic Equivalent Product that is sold by such Third Party for use in the Territory.

 

8.             Par represents, warrants, and covenants that it has not granted or assigned to any Third Party, directly or indirectly, any right or license under or to the Par ANDA or the Par Product, and that it will not, except in accordance with the License Agreement, do any of the foregoing (including, selling, assigning, transferring, or divesting the Par ANDA to a Third Party).  Supernus represents, warrants, and covenants that Supernus is the sole owner of the

 

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Litigated Patents, Supernus possesses the sole right to enforce the Litigated Patents, and Supernus has not granted or assigned, and will not grant or assign, to any Third Party, directly or indirectly, any right under any of the Litigated Patents that would allow such Third Party to sue Par for infringement of any of the Litigated Patents based on Par manufacturing, using, selling, offering for sale, or importing the Par Product.

 

9.             In consideration of the mutual execution of the Settlement Documents and the mutual agreement to be legally bound by the terms hereof, Supernus and Par, with the intention of binding themselves and their respective predecessors, successors, heirs and assigns, directors, officers, employees and representatives, hereby fully, finally and irrevocably release and discharge each other, and their respective predecessors, successors, heirs and assigns, directors, officers, employers and representatives, from any and all actions, causes of action, suits, debts, dues, sums of money, accounts, reckonings, bonds, bills, specialties, covenants, contracts, liabilities, controversies, agreements, promises, variances, trespasses, damages, judgments, extents, executions, claims, counterclaims, demands, costs, expenses, losses, liens and obligations, whatsoever, in law or equity, whether known or unknown, and waive any and all defenses, occurring before or as of the Effective Date related to the Litigated Patents, including (i) in connection with the Pending Litigation, (ii) associated with the Par ANDA and Par Product, and including Supernus’ assertion of the Litigated Patents against Par, or (iii) all other claims that were asserted or could have been asserted in the Pending Litigation.  For purposes of clarity, nothing herein shall inhibit any Party’s ability to enforce the terms of the Settlement Documents; or Supernus’ ability to enforce any patent, including the Litigated Patents against Third Parties; or Par’s ability to assert counterclaims or defenses of non-infringement, invalidity, or unenforceability of the Litigated Patents in any proceeding the subject matter of which is not the Par Product.

 

10.          Supernus and Par each represents and warrants that it has the full right, authority and power to enter into the Settlement Documents on its own behalf, and on behalf of its Affiliates, and that the Settlement Documents shall create and constitute a binding obligation on its part as of the Effective Date.

 

11.          Supernus and Par each will bear its own costs and legal fees for the Pending Litigation.

 

12.          From the execution of the Settlement Documents, and unless the Settlement Documents are terminated, neither Party will actively pursue litigation activities related to the Pending Litigation, except to the extent required by court order or other Applicable Law.  In consideration of the benefits of entering into the Settlement Documents, the Parties, through their respective attorneys, shall, within three (3) Business Days of the Effective Date, jointly seek that the Court enter the Consent Judgment.  In the event that the Court should refuse to enter the Consent Judgment, the Parties shall work together in good faith to modify the Consent Judgment to meet the Court’s requirements, provided that nothing contained herein shall be deemed to require a Party to agree to a modification of the Consent Judgment or any other Settlement Document that materially affects the economic value of the transactions contemplated hereby.  If despite such good faith efforts the Court refuses within thirty (30) days of the Effective Date to

 

3

 

enter the Consent Judgment in the Pending Litigation finding that the Litigated Patents are valid and enforceable and are infringed by the Par Product in the absence of a license, the Settlement Documents shall be null and void ab initio.

 

13.          The Parties shall submit the Settlement Documents to the Federal Trade Commission Bureau of Competition (the “Commission”) and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice (the “DOJ”) as soon as practicable following the Effective Date and in no event later than ten (10) Business Days following the Effective Date.  The Parties shall use all reasonable efforts to coordinate the making of such filings, and shall respond promptly to any requests for additional information made by either of such agencies.  Each Party reserves the right to communicate with the Commission or the DOJ regarding such filings as it believes appropriate.  Each Party shall keep the other reasonably informed of such communications and shall not disclose the confidential information of the other without such other Party’s consent (not to be unreasonably withheld).  To the extent that any legal or regulatory issues or barriers arise with respect to the Settlement Documents, or any subpart thereof, the Parties shall work together in good faith and use reasonable efforts to modify the Settlement Documents to overcome any such legal or regulatory issues (including, for example, objections by the Commission, the DOJ or any applicable court) in a mutually acceptable fashion, but in no event shall either Party be required to agree to any modification of the Settlement Documents that materially affects the economic value of the transactions contemplated hereby.  For purposes of this Settlement Agreement, “reasonable efforts” shall mean reasonable efforts and commitment of resources consistent with such Party’s similarly situated products or projects in order to achieve a stated goal as expeditiously as practical.

 

14.          After entry of the Consent Judgment, the Court shall retain jurisdiction of the Pending Litigation and over the Parties for purposes of enforcement of the provisions of the Consent Judgment.

 

15.          This Settlement Agreement shall terminate upon the expiration of the Litigated Patents and any statutory or regulatory extensions.

 

16.          The Settlement Documents are governed under the provisions of the following Sections of the License Agreement:  5 (Confidentiality); 11.1 and 11.2 (Notice); 11.3 (Assignment); 11.4 (Amendment); 11.5 (Public Announcement); 11.6 (Merger and Integration); 11.7 (Governing Law); 11.8 (Agreement Costs); 11.9 (Counterparts); 11.10 (Severability); 11.11 (Relationship of the Parties); 11.12 (Construction); 11.13 (Dispute Resolution); 11.14 (Cumulative Rights); 11.15 (No Third Party Benefit); 11.16 (Further Assurance); and 11.17 (Waiver).

 

[Signature Page Follows]

 

4

 

[Signature Page to Settlement Agreement Regarding Extended Release Topiramate Oral

Capsule Product]

 

IN WITNESS WHEREOF, the Parties hereto have each caused this Settlement Agreement to be executed by their authorized representatives as of the Effective Date.

 

 

	
SUPERNUS   PHARMACEUTICALS, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Jack Khattar
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Jack   Khattar
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
President   and CEO
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
PAR PHARMACEUTICAL COMPANIES, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Barry J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Barry   J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Vice   President, Legal
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
PAR PHARMACEUTICAL, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Barry J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Barry   J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Vice   President, Legal
    	
 
    

 

5

 

EXHIBIT A

 

LICENSE AGREEMENT

 

BY AND BETWEEN

 

SUPERNUS PHARMACEUTICALS, INC.

 

AND

 

PAR PHARMACEUTICAL COMPANIES, INC.

 

PAR PHARMACEUTICAL, INC.

 

DATED AS OF OCTOBER 14, 2015

 

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (this “License Agreement”) is entered into as of October 14, 2015 (the “Effective Date”) by and between, Supernus Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having offices located at 1550 East Gude Drive, Rockville, Maryland 20850, (“Supernus”), on the one hand, and Par Pharmaceutical Companies, Inc., a corporation organized and existing under the laws of Delaware, having offices located at One Ram Ridge Road, Chestnut Ridge, NY 10977 (“Par Cos.”), and Par Pharmaceutical, Inc., a corporation organized and existing under the laws of Delaware, having offices located at One Ram Ridge Road, Chestnut Ridge, New York 10977 (“Par Inc.” and together with Par Cos., “Par”), on the other hand. Supernus and Par are collectively referred to herein as the “Parties,” or each individually as a “Party.”

 

R E C I T A L S:

 

WHEREAS, Supernus and Par are parties to a certain Settlement Agreement of even date herewith (the “Settlement Agreement”), pursuant to which Supernus and Par are settling the Pending Litigation; and

 

WHEREAS, in accordance with the Settlement Agreement, Supernus and Par have agreed to enter into this License Agreement as part of the Settlement Documents.

 

NOW THEREFORE, in consideration of the foregoing premises, the mutual covenants and agreements described herein and in the Settlement Agreement, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.                                      Definitions.

 

1.1.                            “Accelerated License Date” means the earlier of: (i) the date of a ** all the ** of the ** and ** a ** with respect to a ** to be **; or (ii) the date of the ** of a ** following a ** all the ** of the ** and ** the **, which have not been ** or ** pursuant to a **, to be ** by such **.

 

1.2.                            “Affiliate” means, with respect to a Party, a Person that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person, whether by the ownership of fifty percent (50%) or more of the voting interest of such Person (it being understood that the direct or indirect ownership of a lesser percentage of such interest shall not necessarily preclude the existence of control), or by contract or otherwise.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

 

1.3.                            “AG Product” means a product that is not Labeled with the Trokendi XR® trademark containing the Compound as its sole active ingredient that is Marketed or supplied under the Supernus NDA, described therein now or hereafter.

 

1.4.                            “ANDA” means an Abbreviated New Drug Application to the FDA for approval to Manufacture, and Market a pharmaceutical product in or for the Territory.

 

1.5.                            “Anticipated License Date” means April 1, 2025.

 

1.6.                            “Applicable Law” means the applicable Laws, rules, regulations, guidelines and requirements of any Governmental Authority related to the development, registration, Manufacture, Marketing or importation of the Par Product in or for the Territory or the performance of either Party’s obligations under this License Agreement.

 

1.7.                            “At-Risk Launch” means the First Commercial Sale of a Generic Equivalent Product, other than an Authorized Generic ANDA Product, preceding a Final Court Decision holding all the claims of the Litigated Patents asserted and finally adjudicated against the Third Party to be invalid, unenforceable or not infringed by a Generic Equivalent Product.

 

1.8.                            “At-Risk Launch Date” means the date of an At-Risk Launch.

 

1.9.                            “At-Risk License Date” means the date, following an **, which is the earlier of: (i) if ** with a ** a ** for ** and/or ** or ** of the **, the earlier of (x) ** the **, (y) if the ** was ** in an ** , the date the ** the ** and/or **, and (z) if the ** was ** in ** and the ** the ** and/or ** the ** of (a) ** the date the ** the ** and/or **, and (b) if ** a ** for a ** and/or ** or ** of the ** in an **, the date the ** the ** and/or **; and (ii) if ** does not ** with a ** a ** for ** and/or ** or ** of the ** the **; provided, in each case, that the ** which is the subject of the ** continues to be ** in the ** on such date. Par shall be required to cease Marketing and Shipping the Par Product contemporaneously with the ** of the ** of the ** in conformity with Section 2.3 below.

 

1.10.                     “Authorized Generic ANDA Product” means a ** authorized, whether pursuant to a ** or ** , for Marketing pursuant to an agreement between Supernus and a Third Party. For the avoidance of doubt, if Supernus enters into an agreement with a Third Party that ** the ** of a ** in the Territory, and such agreement includes a ** or the like with respect to ** of such **, such ** shall not be considered an ** by virtue of such ** or the like, provided such ** is no longer being Marketed in the Territory.

 

1.11.                     “Authorized License Date” means the date of the ** of an ** or an **.

 

1.12.                     “Business Day” means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by Law to close.

 

1.13.                     “Claim” means any Third Party claim, lawsuit, investigation, proceeding, regulatory action or other cause of action.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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1.14.                     “Commercially Reasonable Efforts” means efforts and diligence in accordance with Par’s reasonable and sound business, legal, medical and scientific judgment and in accordance with the efforts and resources Par would use in other aspects of its business that have similar commercial value and market potential, taking into account the competitiveness of the marketplace, the business life-cycle, the proprietary position of Par and the profitability of the pertinent product.

 

1.15.                     “Compound” means topiramate.

 

1.16.                     “Confidential Information” means any scientific, technical, formulation, process, Manufacturing, clinical, non-clinical, regulatory, Marketing, financial or commercial information or data relating to the business, projects, employees or products of either Party and provided by one Party to the other by written, oral, electronic or other means in connection with the Settlement Documents.

 

1.17.                     “Consent Judgment” shall have the meaning assigned to such term in the Settlement Agreement.

 

1.18.                     “Covenant Not to Sue” shall have the meaning assigned to such term in Section 3.5.

 

1.19.                     “Effective Date” shall have the meaning assigned to such term in the preamble to this Agreement.

 

1.20.                     “FDA” means the United States Food and Drug Administration or any successor agency thereof.

 

1.21.                     “Final Court Decision” means a final decision of any Federal court from which no appeal has been taken or can be taken within the time permitted therefor (other than a petition to the United States Supreme Court for a writ of certiorari).

 

1.22.                     “First Commercial Sale” means the Shipment by a Third Party of commercial quantities of product for immediate commercial sale to major retail chains, major pharmaceutical wholesalers, or managed care providers in the Territory, which Supernus determines in good faith to have occurred, based on independent and reliable information (including information gained from reliable sources in the trade).

 

1.23.                     “Force Majeure” means any circumstances reasonably beyond a Party’s control, including, acts of God, civil disorders or commotions, acts of aggression, terrorism, fire, explosions, floods, drought, war, sabotage, embargo, utility failures, supplier failures, material shortages, labor disturbances, a national health emergency, or appropriations of property.

 

1.24.                     “GAAP” means generally accepted accounting principles in effect in the United States from time to time, consistently applied.

 

1.25.                     “Generic Equivalent Product” means an extended release oral capsule product containing the Compound as its sole active ingredient which is submitted to the FDA for

 

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Regulatory Approval pursuant to an ANDA or 505(b)(2) application as a Therapeutic Equivalent to Trokendi XR®. For clarity, Generic Equivalent Product shall not include AG Product.

 

1.26.                     “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of: (i) any government of any country; or (ii) a federal, state, province, county, city or other political subdivision thereof.

 

1.27.                     “Label” means any Package labeling designed for use with a product, including the package insert for such product that is approved by the FDA, and “Labeled” or “Labeling” shall have the correlated meaning.

 

1.28.                     “Launch” means the first Shipment of Par Product by Par to a Third Party.

 

1.29.                     “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and ordinances of any Governmental Authority.

 

1.30.                     “License Agreement” shall have the meaning assigned to such term in the preamble to this Agreement.

 

1.31.                     “License and Authorization” shall have the meaning assigned to such term in Section 2.2.

 

1.32.                     “Licensed Patents” means: (i) the Litigated Patents and any patent that issues as a result of a continuation, continuation-in-part, divisional, reexamination or reissue thereof; and (ii) any other present or future U.S., international, or foreign patent owned or controlled by Supernus or any of its Affiliates which claims cover the Manufacturing, Marketing, Shipping, using, or importing of the Par Product.

 

1.33.                     “Litigated Patents” shall have the meaning assigned to such term in the Settlement Agreement.

 

1.34.                     “Losses” means any liabilities, damages, costs or expenses, including reasonable attorneys’ fees and expert fees, incurred by any Party that arises from any claim, lawsuit or other action by a Third Party.

 

1.35.                     “Manufacture” means all activities related to the manufacturing, development and use of a pharmaceutical product, or any ingredient thereof, including, manufacturing Compound or supplies for development, manufacturing a product for commercial sale, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing, and “Manufactured” or “Manufacturing” shall have the correlated meaning.

 

1.36.                     “Market” means to distribute, promote, advertise, market, offer for sale or sell, to a Third Party, and “Marketing” or “Marketed” shall have the correlated meaning.

 

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1.37.                     “Net Sales” shall equal the ** invoiced for sales of the Par Product to Third Parties in the Territory ** all **, all as determined in accordance with ** for other pharmaceutical products and consistent with the customary practices in the generic pharmaceutical industry in the Territory, **, and which, as applicable, are actually ** or specifically **, including:

 

1.37.1              ** or other **;

 

1.37.2              ** and ** and any other **, all to the extent ** to the ** and ** and ** in accordance with applicable law (but ** the ** from such **);

 

1.37.3              ** and **;

 

1.37.4              **, including ** (including those on ** following price changes) and ** for ** or **;

 

1.37.5              **, any other ** actually ** or ** to any person or entity, including ** and to **, including their **, or to **, in each case that are not Affiliates of Par, and that are directly attributable to the sale of the Par Product;

 

1.37.6              **, and like ** that are customary in the industry that are ** from **, and other ** to **; and

 

1.37.7              any ** that Par may incur from any ** purchasing ** pursuant to a written agreement between Par and **.

 

For the sake of clarity, all such ** represent ** to the ** invoiced for sales of the Par Product by Par or its Affiliates to Third Parties in the Territory in accordance with GAAP.

 

1.38.                     “NDA” means a New Drug Application (or equivalent regulatory mechanism) filed with the FDA pursuant to and under 21 U.S.C. § 355(b) (as amended, supplemented or replaced), together with the FDA’s implementing rules and regulations.

 

1.39.                     “Orange Book” means the “Approved Drug Products with Therapeutic Equivalence Evaluations” published by FDA.

 

1.40.                     “Package” means all primary containers, including bottles, cartons, shipping cases or any other like matter used in packaging or accompanying a product, and “Packaged” or “Packaging” shall have the correlated meaning.

 

1.41.                     “Par” shall have the meaning assigned to such term in the preamble to this Agreement.

 

1.42.                     “Par ANDA” shall mean ANDA No. 205976 (together with any amendments, supplements, or other changes thereto) seeking approval to engage in the

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.

 

1.43.                     “Par Attorney or Agent” shall have the meaning assigned to such term in Section 3.5.

 

1.44.                     “Par License Date” means the ** of:

 

1.44.1              the **;

 

1.44.2              an **;

 

1.44.3              an **; or

 

1.44.4              an **.

 

1.45.                     “Par Party” shall have the meaning assigned to such term in Section 7.1.

 

1.46.                     “Par Product” means an extended release oral capsule product containing the Compound as its sole active ingredient, which is the subject of the Par ANDA, including all formulations and strengths thereof, described therein now or hereafter.

 

1.47.                     “Party” or “Parties” shall have the meaning assigned to such term in the preamble to this Agreement.

 

1.48.                     “Pending Litigation” shall have the meaning assigned to such term in the Settlement Agreement.

 

1.49.                     “Person” means any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.

 

1.50.                     “Regulatory Approval” means final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.

 

1.51.                     “Settlement Agreement” shall have the meaning assigned to such term in the Recitals.

 

1.52.                     “Settling Party” shall have the meaning assigned to such term in Section 11.5.

 

1.53.                     “Shipped” means, with respect to a product, when a Person has delivered shipments of such product to a common carrier for shipment to such Person’s customers for resale; in each instance, a “Shipment,” “Ship” or “Shipping” shall have the correlated meaning.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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1.54.                     “Supernus” shall have the meaning assigned to such term in the preamble to this Agreement.

 

1.55.                     “Supernus NDA” means Supernus’ NDA No. 201635, as amended, or supplemented, for the Regulatory Approval of Trokendi XR®.

 

1.56.                     “Supernus Party” shall have the meaning assigned to such term in Section 7.2.

 

1.57.                     “Supernus’ External Auditor” shall have the meaning assigned to such term in Section 4.8.

 

1.58.                     “Term” shall have the meaning assigned to such term in Section 10.1.

 

1.59.                     “Territory” means the United States of America, and its territories, commonwealths, districts and possessions, including the Commonwealth of Puerto Rico.

 

1.60.                     “Therapeutic Equivalent” shall have the meaning given to it by the FDA in the current edition of the Orange Book as may be amended from time to time during the Term.

 

1.61.                     “Third Party” or “Third Parties” means any Person or entity other than a Party or its Affiliates.

 

1.62.                     “Trokendi XR®” means the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing pursuant to the Supernus NDA and is sold in the Territory under the Trokendi XR® trademark.

 

2.                                      License and Authorization

 

2.1.                            Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Par a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use and Market the Par Product in or for the Territory, on and after the applicable Par License Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding the Par Product in or for the Territory prior to the Par License Date (but not to Market (except as provided in Section 3.1) or Ship the Par Product prior to the Par License Date) in sufficient quantities to permit Par to Market and Ship the Par Product in or for the Territory beginning on and after the Par License Date. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the Par Product Supernus hereby waives, effective as of the date that Par is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by Par and if applicable, send the FDA a written confirmation of Supernus’ agreement to waive, effective as of the date that Par is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Par Product or the Par ANDA.

 

2.2.                            The license and authorization granted in Section 2.1 of this License Agreement are referred to herein as the “License and Authorization.” Except to the extent

 

7

 

permitted pursuant to Section 11.3, and without derogating from Par’s “have Manufactured” rights set forth in Section 2.1, Par and its Affiliates shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization.

 

2.3.                            In the event the ** becomes effective due to an ** and there are thereafter no longer any ** the ** in the ** (other than ** or ** subject to substantially the same provisions as set forth in this Section), ** from ** to ** under the ** shall immediately terminate, and ** and ** shall ** the ** of ** until such subsequent ** as another event constituting a ** shall have occurred.

 

2.4.                            Except as set forth in the License and Authorization or expressly set forth in this License Agreement or other Settlement Documents, there are no authorizations, licenses or rights granted by either Party under this Agreement, by implication, estoppel or otherwise, including any right granted to Par or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Par ANDA. All rights not expressly granted by Supernus herein are hereby retained by Supernus. In addition, except as expressly set forth in this License Agreement or other Settlement Documents, Supernus explicitly retains the right itself or through an Affiliate to Market an AG Product, and Supernus is free to grant a license under the Licensed Patents or supply AG Product to any Third Party.

 

3.                                      Conditions

 

3.1.                            Par and its Affiliates hereby agree not to Market or Ship Par Product in the Territory prior to the applicable Par License Date. Notwithstanding the foregoing, Par and its Affiliates shall be permitted ** in advance of the ** to (i) ** of the ** on ** Par and its Affiliates would be ** to ** the **; and (ii) ** in ** and ** and ** and ** with respect to the **.

 

3.2.                            Par and its Affiliates hereby agree not to: (i) challenge the validity or enforceability of the Litigated Patents; (ii) aid, abet, assist, enable or participate with any Third Party in a challenge to the validity or enforceability of the Litigated Patents or the noninfringement by a Generic Equivalent Product of the Litigated Patents in or for the Territory; (iii) Market or Manufacture a Generic Equivalent Product other than the Par Product pursuant to the License and Authorization; or (iv) aid, abet, enable or contract with any Third Party regarding the Marketing or Manufacturing of any Generic Equivalent Product in or for the Territory other than the Par Product. Notwithstanding the foregoing, nothing herein shall prohibit Par from asserting any and all counterclaims or defenses of invalidity, non-infringement or unenforceability in view of the Litigated Patents in any proceeding the subject matter of which is not the Par Product.

 

3.3.                            In addition to any other right or remedy Supernus may be entitled to, in the event that Par or its Affiliates breaches Sections 3.1, 3.2 or 3.6 during the Term, Supernus may, at its sole discretion, immediately, effective upon notice to Par, terminate all, or any of, the License Agreement or the Settlement Agreement.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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3.4.                            Nothing set forth herein or in the other Settlement Documents shall be deemed to give Supernus any control over any Marketing exclusivity that may be granted to Par by the FDA in connection with the Par ANDA or the Par Product.  Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict Par from Manufacturing or Marketing any Generic Equivalent Product which would not infringe the Licensed Patents, and nothing herein shall prohibit Par from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe the Licensed Patents.

 

3.5.                            Supernus hereby covenants not to sue Par or any of its shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the foregoing, or cause or authorize any person or entity to do any of the foregoing, claiming or otherwise asserting that the manufacture, use, sale, offer for sale, or importation of the Par Product infringes the Licensed Patents (the “Covenant Not to Sue”).  Supernus will impose the foregoing Covenant Not to Sue on any Third Party to which Supernus may assign, grant a right to enforce, or otherwise transfer (by any means) any of the Licensed Patents subject to the foregoing Covenant Not to Sue.  The Covenant Not to Sue shall not apply in the event Par or its Affiliates has violated the Consent Judgment or if Supernus has terminated this License Agreement or the Settlement Agreement.  For any of the Licensed Patents listed in the Orange Book for Trokendi XR®, the Covenant Not to Sue will hereby be treated as a non-exclusive license, so that Par or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) and 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect to the Par ANDA.

 

3.6.                            Par and its Affiliates shall not release (including any oral or written release or waiver of any right) any attorney (including any of the attorneys or law firms of record in the Pending Litigation) or any agent or consultant (whether retained by Par, its Affiliates, or by any attorney that represents Par) (“Par Attorney or Agent”) to:  (i) assist, or cooperate with, any Third Party (including any current or future litigant in a litigation against Supernus) with respect to a Generic Equivalent Product, the Litigated Patents (insofar as the Litigated Patents are being asserted in a proceeding the subject matter of which is a Generic Equivalent Product), or otherwise with respect to Trokendi XR® in the Territory, or (ii) take any action on behalf of a Third Party which, if taken by Par, would be prohibited under Section 3.2.  Par and its Affiliates shall not release, grant a waiver of conflict of interest or otherwise take any action which would allow or permit any Par Attorney or Agent to (i) breach the confidentiality of non-public information to which such attorney had access in connection with the Pending Litigation; or (ii) represent or otherwise assist any Third Party (including any current or future litigant in a litigation against Supernus) with respect to a Generic Equivalent Product, the Litigated Patents (insofar as the Litigated Patents are being asserted in a proceeding the subject matter of which is a Generic Equivalent Product), or otherwise with respect to Trokendi XR® in the Territory. Neither Par, its Affiliates, nor any Par Attorney or Agent will provide to any Third Party any confidential information or attorney work product relating to the Litigated Patents, or otherwise with respect to Trokendi XR® in the Territory, unless subpoenaed or otherwise ordered by Governmental Authority.  In the event that Par, its Affiliates, or any Par Attorney or Agent is subpoenaed or otherwise ordered by Governmental Authority to disclosure any confidential 

 

9

 

information or attorney work product relating to the Litigated Patents (insofar as the Litigated Patents are being asserted in a proceeding the subject matter of which is a Generic Equivalent Product), or otherwise with respect to Trokendi XR® in the Territory:  (i) Par shall immediately notify Supernus and allow Supernus to seek a protective order or move to quash the subpoena or to otherwise protect the information requested; and (ii) the Parties shall communicate, cooperate fully with and reasonably assist one another in any proceeding related thereto.

 

3.7.                            **.  In the event Supernus in the future ** a ** to a ** to sell a ** with a ** that is ** the ** herein, then the ** herein will ** be ** so that the ** the ** to such **.

 

4.                                      Marketing of Par Product

 

4.1.                            Par shall, at its sole cost and expense, utilize Commercially Reasonable Efforts in Marketing the Par Product in the Territory to maximize sales of Par Product.  Par will have **, however, in ** for the ** of the Par Product in the Territory.

 

4.2.                            Except as provided in Section 11.3, only Par and its Affiliates shall be permitted to Launch and Market Par Product under this License Agreement.

 

4.3.                            Par Royalty.  For any Par Product sold during the Term, Par will pay to Supernus a royalty as follows:

 

4.3.1                     ** of Net Sales on Par Product sold (as determined by ** for other pharmaceutical products, **) during any period when the ** is ** or **;

 

4.3.2                     ** of Net Sales on Par Product sold (as determined by ** for other pharmaceutical products, **) during any period when the Par Product is ** with ** or **;

 

4.3.3                     ** of Net Sales on Par Product sold (as determined by ** for other pharmaceutical products, **) during any period when the Par Product is ** with ** or **; or

 

4.3.4                     Notwithstanding Sections 4.3.1 through 4.3.3, ** of Net Sales on Par Product sold (as determined by ** for other pharmaceutical products, **) following an ** the ** of a **.

 

4.4.                            Royalty Payments.  Payments due under this Section 4 shall be made within ** from the end of each calendar quarter in which Par Product is sold.  All such payments shall include a report provided consistent with the antitrust laws which details the calculation of gross sales, Net Sales and the royalties payable hereunder.  The Parties agree that in the event that Net Sales of the Par Product for any quarter are negative (“Negative Net Sales”), Par shall not owe any royalty payment to Supernus during such quarter and further agree that such Negative Net Sales shall be carried forward and applied in future quarters in accordance with GAAP.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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4.5.                            Annual True-Up.  Within one hundred and eighty (180) days after the end of each calendar year during the Term in which fees are payable to Supernus pursuant to this Section 4, Par shall perform a “true up” reconciliation (and shall provide Supernus with a written report of such reconciliation) of the items comprising deductions from Net Sales other than returns.  The reconciliation shall be based on actual cash paid or credits actually issued plus an estimate for any remaining liabilities incurred related to Par Product but not yet paid.  If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within thirty (30) days of the date of delivery of such report.

 

4.6.                            Final True-Up.  Within twenty-five (25) months of the end of the last calendar year during the Term in which fees are payable to Supernus pursuant to this Section 4, Par shall perform a “true-up” reconciliation (and shall provide Supernus with a written report of such reconciliation) of the items comprising deductions from Net Sales for returns.  The reconciliation shall be based on actual cash paid or credits issued for returns, through the twenty- four (24) month period following the termination of the Term.  If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within thirty (30) days of the date of delivery of such report.

 

4.7.                            Maintenance of Records.  During the Term, and for a period of three (3) years thereafter, Par shall, and shall ensure that its Affiliates shall, keep at either its normal place of business, or at an off-site storage facility, detailed, accurate and up to date:

 

4.7.1                     records and books of account sufficient to confirm the calculation of the gross sales, Net Sales and the royalties payable hereunder; and

 

4.7.2                     information and data contained in any invoices or reports accompanying any payment to Supernus provided to Supernus in connection with this License Agreement.

 

4.8.                            Inspection.  On no less than ** notice from Supernus, Par shall make all the records, books of account, information and data referred to in this Section 4.8 of this License Agreement available for inspection during normal business hours by an internationally recognized independent accounting firm selected by Supernus and reasonably acceptable to Par that is not paid in whole or in part by a contingent fee arrangement, (“Supernus’ External Auditor”) for the purpose of general review or audit; provided that Supernus may not request such inspection more than once in any calendar year.  Upon reasonable belief of discrepancy or dispute, Supernus’ External Auditor shall be entitled to take copies or extracts from such records, and books of account (but only to the extent related to the contractual obligations set out in this License Agreement) during any review or audit, provided Supernus’ External Auditor signs a confidentiality agreement with Par providing that such records, and books of account shall be treated as Confidential Information which may not be disclosed to any Third Party.  Supernus’ External Auditor shall only disclose to Supernus the results of the Supernus’ External Auditor’s

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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audit, which results shall be concurrently disclosed to Par .  Any underpayment of amounts due hereunder as reflected by Supernus’ External Auditor’s results shall be promptly paid by Par to Supernus.

 

4.9.                            Inspection Costs.  Supernus shall be solely responsible for its and Supernus’ External Auditor’s costs in making any such review and audit, unless Supernus’ External Auditor identifies a discrepancy in the calculation of royalties paid to Supernus under this License Agreement in any calendar year from those properly payable for that calendar year of ** or greater, in which event Par shall be solely responsible for the cost of such review and audit and shall pay Supernus any payment due.  All information disclosed by Par or its Affiliates pursuant to this Section 4 shall be deemed Confidential Information.

 

4.10.                     Payment Method.  All payments to be made by Par to Supernus under this License Agreement shall be in United States dollars in immediately available funds and shall be made by wire transfer to an account designated by Supernus, such account to be designated by Supernus at least ** prior to the date any such payment is due.  Any payments to be made by Supernus to Par under this License Agreement shall be in United States dollars in immediately available funds and shall be made by wire transfer to an account designated by Par for such purpose.

 

4.11.                     Late Payments.  In addition to any other rights and remedies, in the event payments required to be made under this License Agreement are not made on or prior to the required payment date, or cured within ** thereafter, the amount of the late payment shall bear interest at the lesser of ** above the prime rate reported in The Wall Street Journal (Eastern Edition) on the date such payment was due and the maximum permissible rate under the Law commencing on the date such payment is due until such date as the payment is made.

 

4.12.                     Taxes.  Supernus shall be responsible for and shall pay all taxes payable on any income or any payments by Par to Supernus.  Par and Supernus shall bear sole responsibility for payment of compensation to their respective personnel, employees or subcontractors and for all employment taxes and withholding with respect to such compensation pursuant to Applicable Law.  Par shall have the right to withhold taxes in the event that the revenue authorities in any country require the withholding of taxes on amounts paid hereunder to Supernus.  Par shall secure and promptly send to Supernus proof of such taxes, duties or other levies withheld and paid by Par for the benefit of Supernus.  Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

 

5.                                      Confidentiality

 

5.1.                            Confidentiality Obligation.  The Parties and their respective employees, directors, officers, consultants and contractors shall keep and maintain as confidential any Confidential Information supplied by the other Party during the Term.  The confidentiality and

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

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non-disclosure obligations contained in the Settlement Documents shall not apply to the extent that, such Confidential Information is:

 

5.1.1                     at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;

 

5.1.2                     after disclosure by one Party to the other becomes part of the public domain, other than by breach by a Party of any obligation of confidentiality;

 

5.1.3                     information which the receiving Party can establish by competent evidence was already in its possession at the time of receipt or was independently developed by the receiving Party; or

 

5.1.4                     received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.

 

5.2.                            Exceptions.  Notwithstanding Section 5.1, in addition to any disclosure allowed under Section 11.5 the Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has been ordered by a court of law or directed by a Governmental Authority, provided that, the disclosure is limited to the extent ordered or directed and wherever practicable, the Party that owns the Confidential Information has been given sufficient written notice in advance to enable it to seek protection or confidential treatment of such Confidential Information.

 

5.3.                            Expiration of Confidentiality.  The confidentiality obligation contained in this Section 5 shall survive the termination or expiry of this License Agreement for so long as such Confidential Information remains confidential.

 

5.4.                            Disclosure.  If a Party is subpoenaed or otherwise requested by any Person, including any Governmental Authority, to give testimony or provide information which in any way relates to the Settlement Documents, the Par Product or practices associated with the Par Product, such Party shall give the other Party prompt notice of such request, and unless otherwise required by Law, shall make no disclosure until such other Party has had a reasonable opportunity to contest the right of the requesting Person to such disclosure.  Notwithstanding the foregoing, either Party may state publicly that the Pending Litigation has been settled on terms that are confidential.  Both Parties acknowledge that the dismissal of the Pending Litigation and entry of the Consent Judgment shall be or become public knowledge.

 

5.5.                            Enforcement.  The Parties agree that equitable relief, including injunctive relief and specific performance, is appropriate in enforcing the confidentiality provisions of the Settlement Documents.  In the event of any such action, the prevailing Party will be entitled to recover, in addition to any charges fixed by the court, its costs and expenses of suit, including reasonable attorney’s fees.  Such remedies shall not be deemed to be the exclusive remedies for a breach of this provision, but shall be in addition to all other remedies available at law or equity.

 

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6.                                      Representations and Warranties of Parties

 

Supernus represents and warrants to Par that Supernus possess the rights and authority to grant the License and Authorization to Par and, with respect to Sections 6.1 and 6.2 below, each of Supernus and Par represents, warrants, and covenants, to the other Party that:

 

6.1.                            Organization and Authority.  Such Party is a corporation duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation.  Such Party has the requisite power and authority to enter into the Settlement Documents.  Such Party has the requisite power and authority to execute and deliver the Settlement Documents and to perform all of its obligations hereunder.  The execution and delivery of the Settlement Documents and the performance by such Party of its obligations hereunder have been authorized by all requisite action on its part.  The Settlement Documents have been validly executed and delivered by such Party, and, assuming that such documents have been duly authorized, executed and delivered by the other Party, constitutes a valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

 

6.2.                            Consents and Approvals; No Violations.

 

6.2.1                     Except as otherwise set forth in this License Agreement or other Settlement Documents, no material filing with, and no material permit, authorization, consent, or approval, of or from any Governmental Authority is required to be obtained by or on behalf of such Party with respect to the transactions contemplated by the Settlement Documents, except for those filings, permits, authorizations, consents or approvals, the failure of which to be made or obtained would not materially impair such Party’s ability to consummate the transactions contemplated hereby or materially delay the consummation of the transactions contemplated hereby.

 

6.2.2                     Neither the execution nor the delivery of the Settlement Documents by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of incorporation, certificate of formation, by-laws or other organizational document of such Party; (ii) conflict in any material respect with or result in a material violation or breach of, or constitute a material default under, any material contract, agreement or instrument to which such Party is a party; or (iii) violate or conflict in any material respect with any material Law applicable to such Party.

 

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7.                                      Indemnities; Product Liability; Insurance

 

7.1.                            Indemnity by Supernus.  Supernus shall defend, indemnify and hold harmless each of Par and its Affiliates and its and their directors, officers, employees and contractors (each a “Par Party”) from and against any and all Losses, arising from or in connection with:

 

7.1.1                     any Claim resulting from any negligent acts or acts of willful misconduct of any Supernus Party in connection with the performance of its obligations under this License Agreement; or

 

7.1.2                     the breach by Supernus of any of its representations or warranties contained in this License Agreement,

 

except, in each case, to the extent such Losses are caused by the negligence, breach of the terms of this License Agreement, or willful misconduct of a Par Party.

 

7.2.                            Indemnity by Par.  Par shall defend, indemnify and hold harmless each of Supernus and its Affiliates and its and their directors, officers, employees and contractors (each, a “Supernus Party”) from and against any and all Losses arising from or in connection with:

 

7.2.1                     any Claim resulting from any negligent acts or acts of willful misconduct of any Par Party in connection with the performance of its obligations under this License Agreement;

 

7.2.2                     any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of Par Product, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of Par Product; or

 

7.2.3                     the breach by Par of any of its representations or warranties contained in this License Agreement,

 

except, in each case, to the extent that such Losses are caused by the negligence, breach of the terms of this License Agreement, or willful misconduct of a Supernus Party.

 

7.3.                            Control of Proceedings.  A Party seeking indemnification hereunder shall provide prompt written notice thereof to the other Party (and, in any event, within thirty (30) days) of the assertion of any Claim against such indemnified Party as to which indemnity is to be requested hereunder.  The indemnifying Party shall have the sole control over the defense of any Claim, provided that, the indemnifying Party shall obtain the written consent of the indemnified Party prior to settling or otherwise disposing of such Claim if as a result of the settlement or Claim disposal the indemnified Party’s interests are in any way adversely affected.

 

15

 

7.4.                            No Admissions.  The indemnified Party shall not make any payment or incur any expenses in connection with any liability for which such Party is seeking indemnification, or make any admissions or do anything that may compromise or prejudice the defense of any Claim without the prior written consent of the indemnifying Party.

 

7.5.                            Claim Information.  Each Party shall promptly:

 

7.5.1                     inform the other by written notice of any actual or threatened Claim to which Sections 7.1 or 7.2 apply;

 

7.5.2                     provide to the other Party copies of all papers and official documents received in respect of any such Claim; and

 

7.5.3                     cooperate as reasonably requested by the other Party in the defense of any such Claim, provided any actual out of pocket costs incurred in connection with such cooperation shall be at the expense of the indemnifying Party.

 

7.6.                            Limitation of Liability.  Except as may be included in a Claim under Section 7.1, 7.2 or 7.8, or a breach by any Party of Section 3 or Section 11.5, in no event shall any Party or its Affiliates be liable for special, punitive, indirect, incidental or consequential loss or damage based on contract, tort or any other legal theory arising out of this License Agreement.

 

7.7.                            Product Liability Insurance.  Each Party shall maintain, at its own cost, general commercial liability insurance (including comprehensive product liability) in such amount as such Party customarily maintains with respect to its other products and which is reasonable and customary in the U.S.  pharmaceutical industry for companies of comparable size and activities, but in any event not less than ** per occurrence and ** in the aggregate.  In the event the insurance policy obtained by a Party is a “claims made” policy (as opposed to an “occurrence” policy), such Party shall obtain comparable insurance for not less than ** following the expiry or termination of this License Agreement.  Notwithstanding anything to the contrary contained herein, either Party may fulfill all of its obligations hereunder through the purchase of commercial insurance, self-insurance or through a combination of both.

 

7.8.                            Irreparable Harm.  Par and its Affiliates acknowledge that in the event of a Launch or continued Marketing or Shipping by Par or its Affiliates of Par Product or any other Generic Equivalent product in the Territory other than as permitted under this License Agreement, the damages to Supernus and its business (including, but not limited to, lost sales of Trokendi XR®) would be difficult to calculate and the adequacy of monetary damages calculated at Law would be uncertain.  Accordingly, Par and its Affiliates agree that in any action by Supernus seeking injunctive or other equitable relief in connection with any such Launch or continued Marketing or Shipping, other than as permitted under this License Agreement, Par and its Affiliates shall not assert or plead the availability of an adequate remedy at Law as a defense to the obtaining of any such remedy.  Par and its Affiliates hereby waive any equitable defense to such injunction including, laches, unclean hands, acquiescence or any estoppel arguments.  The

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

16

 

foregoing shall not be in lieu of any other remedy to which Supernus may be entitled hereunder in equity or at law as a result of such a breach.

 

7.9.                            Limitation on Representations, Warranties and Indemnification.  NEITHER PARTY SHALL BE DEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT AS SPECIFICALLY SET FORTH HEREIN.  ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.

 

8.                                      Force Majeure

 

8.1.                            Force Majeure.  Neither Party shall be entitled to terminate this License Agreement or shall be liable to the other under this License Agreement for loss or damages attributable to any Force Majeure, provided the Party affected shall give prompt notice thereof to the other Party.  Subject to Section 8.2, the Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure.

 

8.2.                            Continued Force Majeure.  If any Force Majeure continues unabated for a period of at least ninety (90) days, the Parties shall meet to discuss in good faith what actions to take or what modifications should be made to this License Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party.

 

9.                                      Trademarks and Trade Names

 

9.1.                            This License Agreement conveys no rights to either Party to use any trademark or trade dress of the other Party, and conveys no rights to any other intellectual property of either Party other than pursuant to the License and Authorization.

 

10.                               Term and Termination

 

10.1.                     Term.  Unless sooner terminated in accordance with the terms hereof, the term of this Agreement shall extend from the Effective Date until the expiration of the Litigated Patents (the “Term”).

 

10.2.                     Termination.  In addition to Supernus’ right to immediately terminate this License Agreement as set forth in Section 3, either Party shall be entitled to terminate this License Agreement by written notice to the other if:

 

10.2.1              the other Party commits a material breach of this License Agreement, and fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 10.2; or

 

10.2.2              an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purposes of solvent amalgamation or reconstruction) or an order is made for the appointment of an administrator to

 

17

 

manage the other Party’s affairs, business and property or if a receiver (which expression shall include an administrative receiver) is appointed over any of the other Party’s assets or undertaking or if circumstances arise which entitle the court or a creditor to appoint a receiver or manager or which entitle the court to make a winding-up order or if a voluntary arrangement is proposed in respect of the other Party or if the other Party takes or suffers any similar or analogous action in consequence of debt, and such order, appointment or similar action is not removed within ninety (90) days.

 

10.3.                     Effect of Termination.  In the event of expiry or termination of this License Agreement for any reason, each Party shall promptly return all Confidential Information of the other Party provided during the Term or destroy and certify the destruction of such Confidential Information.

 

10.4.                     Liability on Termination.  The termination or expiry of this License Agreement shall not release either of the Parties from any liability which at the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of the Parties which is expressly stated elsewhere in this License Agreement to survive such termination or expiry.

 

10.5.                     Surviving Sections.  The provisions of Sections 1, 4.4 - 4.13, 5, 7, 10.3 - 10.5, and 11 shall continue in force in accordance with their respective terms notwithstanding expiry or termination of this License Agreement for any reason.

 

11.                               Miscellaneous

 

11.1.                     Notice.

 

11.1.1              Any notice or other document given under the Settlement Documents shall be in writing in the English language and shall be given by hand or sent by prepaid overnight mail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 11.2 below unless a different address or fax number has been notified to the other in writing for this purpose.

 

11.1.2              Each such notice or document shall:

 

(i)                                   if sent by hand, be deemed to have been given when delivered at the relevant address;

 

(ii)                                if sent by prepaid mail, be deemed to have been given five (5) days after posting; or

 

(iii)                             if sent by confirmed fax transmission be deemed to have been given when transmitted, provided that, a confirmatory copy of such fax or other electronic method of transmission

 

18

 

shall have been sent by prepaid overnight mail within one (1) Business Day of such transmission.

 

11.2.                     Address for Notice.  The address for services of notices and other documents on the Parties shall be:

 

To Supernus

 

Supernus Pharmaceuticals, Inc.

1550 East Gude Drive

Rockville, MD 20850

Attn:  President

Fax:  **

 

with a copy to:

 

Edgar H. Haug

Frommer Lawrence & Haug LLP

745 Fifth Avenue

New York, NY 10151

Fax:  (212) 588-0500

 

To Par

 

Par Pharmaceutical, Inc.

One Ram Ridge Road

Chestnut Ridge, New York 10977

Attn:  General Counsel

Fax:  **

 

with a copy to:

 

Daniel G. Brown

Latham & Watkins LLP

885 Third Avenue

New York, New York 10022

Fax:  (212)751-4864

 

11.3.                     Assignment.

 

11.3.1              Subject to Section 11.3.2, neither Party shall assign or transfer any of its rights or obligations under the Settlement Documents without the prior written consent of the other Party, not to be unreasonably withheld or delayed.

 

**                                  This portion has been redacted pursuant to a confidential treatment request.

 

19

 

11.3.2              Each Party shall be entitled, without prior written consent of the other Party, to assign all, but not less than all, of its rights or obligations under the Settlement Documents to an Affiliate or transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of such Party (whether by consolidation, sale of assets, or otherwise); provided the Affiliate or other successor entity expressly assumes in writing those rights, duties and obligations under the Settlement Documents and the Affiliate or other successor is a financially capable business entity.  The assignment of the Settlement Documents by Par and its Affiliates shall not in any way affect Par’s or its Affiliates’ duties, obligations and admissions in the Settlement Documents, and Par and its Affiliates will continue to be bound by the terms of the Consent Judgment.

 

11.3.3              Subject to the foregoing, the Settlement Documents shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.  Any assignment or transfer in contravention of the terms of the Settlement Documents shall be null and void.

 

11.4.                     Amendment.  The Settlement Documents may not be varied, changed, amended, supplemented, waived, discharged or terminated, including by course of conduct or trade usage, except by an instrument in writing signed by the Party against which enforcement of such variation, change, amendment, supplement, waiver, discharge or termination is sought.

 

11.5.                     Public Announcements.  The Parties shall maintain in confidence the terms of the Settlement Documents and the negotiations of the Parties pertaining thereto.  Without limiting the generality of the foregoing, neither Party nor its counsel shall provide discovery (including without limitation documents, oral testimony or statements whether by deposition or otherwise, the work of outside experts or consultants, or work product embodying any of the above) to any Third Party in any judicial or arbitral proceeding pertaining to the Settlement Documents in the Territory.  Notwithstanding these obligations, (i) Par may issue a press release with the prior written consent of Supernus (such consent to be at the sole discretion of Supernus) but may state publicly that the Pending Litigation has been settled on terms that are confidential, which public statement may be made without the prior written consent of Supernus; (ii) Supernus may issue a press release without the consent of Par; (iii) either Party may disclose such terms in discovery as otherwise required by court order, provided that the other Party shall be given the opportunity to (a) review and comment on the proposed disclosure reasonably in advance of the disclosure, and (b) quash such order and to obtain a protective order requiring that the information and documents that are the subject of such order be held in confidence by such court; (iv) either Party may disclose such terms on a need-to-know basis to such Party’s actual and prospective investors, prospective acquirers, underwriters and lenders, attorneys, accountants, insurers and FDA consultants, so long as the disclosed-to entity is bound by rules of professional conduct, or has agreed in writing and in advance to maintain the confidentiality of such information under terms no less restrictive than those set forth herein; (v) Supernus may disclose the terms of the Settlement Documents to a Third Party litigant in any patent litigation or other legal proceeding (or settlements thereof) relating to the Litigated Patents or Trokendi

 

20

 

XR®, (vi) Par may disclose such terms to the FDA as may be necessary or useful in obtaining and maintaining Regulatory Approval of the Par ANDA and Launching the Par Product as provided by the Settlement Documents, so long as Par requests that the FDA maintain such terms in confidence, and (vii) either Party may disclose such terms as otherwise required by Law, including without limitation SEC reporting requirements, or by the rules or regulations of any stock exchange to which the Parties are subject; provided that the Parties will coordinate in advance with each other in connection with the redaction of certain provisions of the Settlement Documents with respect to any SEC filings, and each Party shall use reasonable efforts to seek confidential treatment for such terms; provided, however, that each Party shall ultimately retain control over what information to disclose to the SEC or any other such agencies.

 

11.6.                     Merger and Integration.  The Settlement Documents supersede all prior discussions and writings of the Parties and constitute the entire agreement between the Parties with respect to the subject matter contained therein.  Any breach of the License Agreement or Settlement Agreement shall constitute a breach of the Settlement Documents as a whole.  Each of the Settlement Documents shall be deemed of equal dignity to each other and shall be construed together in a consistent manner as reflecting a single intent and purpose.  It is agreed that:  (i) neither Party has entered into any of the Settlement Documents in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in the Settlement Documents; (ii) neither Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in Settlement Documents; and (iii) this Section 11.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation.

 

11.7.                     Governing Law.  The Settlement Documents shall be governed by the Laws of the State of New York without regard to the conflicts of law provisions thereof.  The Parties irrevocably agree that the United States District Court for the Southern District of New York shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with the Settlement Documents and that, accordingly, any proceedings arising out of or in connection with the Settlement Documents shall be brought in the United States District Court for the Southern District of New York.  Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the Southern District of New York does not have subject matter jurisdiction, the state courts in the county and state of New York shall have jurisdiction.  In connection with any dispute arising out of or in connection with the Settlement Documents, each Party (i) hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of New York and (ii) hereby irrevocably waives any right to a trial by jury.

 

11.8.                     Agreement Costs.  Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of the Settlement Documents.

 

11.9.                     Counterparts.  The Settlement Documents may be executed in any number of counterparts and may be executed by the Parties on separate counterparts (including fax or electronic counterparts), each of which is an original but all of which together constitute the same instrument.

 

21

 

11.10.              Severability.  If and to the extent that any provision of the Settlement Documents is held to be illegal, void or unenforceable, such provision shall be given no effect and shall be deemed not to be included in the Settlement Documents but without invalidating any of the remaining provisions of the Settlement Documents.

 

11.11.              Relationship of the Parties.  In making and performing the Settlement Documents, the Parties are acting, and intend to be treated, as independent entities; and nothing contained in the Settlement Documents shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between Supernus and Par.  Except as otherwise provided herein, neither Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of the other Party.

 

11.12.              Construction.  The language in all parts of the Settlement Documents shall be construed, in all cases, according to its fair meaning.  Supernus and Par acknowledge that each Party and its counsel have reviewed and revised the Settlement Documents and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation thereof.  The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in the Settlement Documents, shall refer to the agreements as a whole and not to any particular provision thereof.  The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.  Whenever used herein, the words “include,” “includes” and “including” shall mean “include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively.  The masculine, feminine or neuter gender and the singular or plural number shall each be deemed to include the others whenever the context so indicates.  With respect to any particular action or agreement, the use of the words “Supernus shall” or “Supernus will” herein shall also mean “Supernus shall cause” the particular action to be performed.  Similarly, with respect to any particular action or agreement, the use of the words “Par shall” or “Par will” herein shall also mean “Par shall cause” the particular action to be performed.  Nothing in the Settlement Documents shall operate to exclude any provision implied into the Settlement Documents by Law and which may not be excluded by Law or limit or exclude any liability, right or remedy to a greater extent than is permissible under Law.

 

11.13.              Dispute Resolution.

 

11.13.1       Preliminary Process.  If there is a disagreement between the Parties as to the interpretation of the Settlement Documents in relation to any aspect of the performance by either Party of its obligations thereunder, the Parties shall, within thirty (30) days of receipt of a written request from either Party, meet in good faith and try to resolve the disagreement without recourse to legal proceedings.

 

11.13.2       Escalation of Dispute.  If resolution of the disagreement does not occur within ten (10) Business Days after such meeting, the matter shall be escalated to applicable Par and Supernus Presidents (or other ranking senior executive) for resolution.

 

22

 

11.13.3       Equitable Relief.  Nothing in this Section 11.13 restricts either Party’s freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary or trade secret right, or to otherwise seek legal remedies through any available channel if resolution is not otherwise achieved under this Section 11.13.

 

11.14.              Cumulative Rights.  The rights and remedies of each of the Parties under or pursuant to the Settlement Documents are cumulative, may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general law.

 

11.15.              No Third Party Benefit.  The Settlement Documents shall be binding upon and inure solely to the benefit of the Parties hereto, their Affiliates, successors and permitted assigns, and nothing in the Settlement Documents, express or implied, is intended to or shall confer upon any other Person or Persons any right, benefits or remedies of any nature whatsoever under or by reason of any of the Settlement Documents.

 

11.16.              Further Assurance.  Each of the Parties shall do, execute and perform and shall procure to be done and perform all such further acts, deeds, documents and things as the other Party may reasonably require from time to time to give full effect to the terms of the Settlement Documents.

 

11.17.              Waiver.  No failure or delay by either Party in exercising any right or remedy provided by law under or pursuant to the Settlement Documents shall impair such right or remedy or operate or be construed as a waiver, acquiescence or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the exercise of any other right or remedy.  A waiver by a Party of any right or remedy hereunder on any one occasion shall not be construed as a bar to any right or remedy which such Party would otherwise have on any future occasion.

 

[Signature Page Follows]

 

23

 

[Signature Page to License Agreement Regarding Extended Release Topiramate Oral Capsule Product]

 

IN WITNESS WHEREOF, the Parties hereto have each caused this Settlement Agreement to be executed by their authorized representatives as of the Effective Date,

 

	
SUPERNUS   PHARMACEUTICALS, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Jack Khattar
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Jack   Khattar
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
President   and CEO
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
PAR PHARMACEUTICAL   COMPANIES, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Barry J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Barry   J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Vice   President, Legal
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
PAR PHARMACEUTICAL, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Barry J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
Barry   J. Gilman
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Vice   President, Legal
    	
 
    
	
 
    	
 
    	
 
    

 

 

EXHIBIT B

 

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

 

	
SUPERNUS   PHARMACEUTICALS, INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
C.A. No. 2:15-00326-SDW-SCM
    	
 
    
	
 
    	
Plaintiff,
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
v.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
PAR   PHARMACEUTICAL COMPANIES, INC. and

PAR   PHARMACEUTICAL, INC. 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Defendants.
    	
 
    	
 
    
								

 

JUDGMENT AND ORDER OF PERMANENT INJUNCTION

 

This action for patent infringement having been brought by Plaintiff Supernus Pharmaceuticals, Inc.  (“Supernus”) against Defendants Par Pharmaceutical Companies, Inc., and Par Pharmaceutical, Inc.  (collectively, “Par”) for infringement of United States Patent Nos.  8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989 (collectively, the “Litigated Patents”);

 

Par and Supernus have entered into a Settlement Agreement and a License Agreement under which Supernus has granted Par a license to the Litigated Patents, on the terms and conditions in the Settlement Agreement and License Agreement;

 

Par acknowledges that selling, offering for sale, using or importing into the United States an extended release topiramate oral capsule product under Abbreviated New Drug Application No.  205976 (the “Par Product”), which ANDA references NDA 201635, the marketing approval for Supernus’ Trokendi XR® product, would infringe each of the Litigated Patents in the absence of a license; and

 

Par acknowledges, as stated and limited herein, that the Litigated Patents, and all the claims contained therein, are valid and enforceable.

 

Supernus and Par now consent to this Judgment and Order.

 

 

IT IS HEREBY ORDERED, ADJUDGED AND DECREED:

 

1.                                      This Court has jurisdiction over the parties and subject matter of this action.

 

2.                                      Par would infringe each of the Litigated Patents by using, making, selling, offering to sell, or importing the Par Product in the United States.

 

3.                                      The Litigated Patents, and all the claims contained therein, are valid and enforceable.

 

4.                                      All affirmative defenses, claims and counterclaims which have been or could have been raised by Par in this action with respect to the Litigated Patents are dismissed with prejudice.

 

5.                                      Except as authorized or licensed by Supernus, Par , its officers, agents, servants, employees, affiliates, successors and all persons in active concert or participation with Par, are permanently enjoined from using, offering for sale, making, selling, or manufacturing in the United States, or importing into the United States, the Par Product or inducing or assisting others to use, offer for sale, make, sell, or manufacture in the United States, or import into the United States, the Par Product.

 

6.                                      In any other or future cause of action or litigation in the United States the subject matter of which is a product marketing approval application referencing NDA 201635, Par shall not dispute that the Litigated Patents are each infringed by using, making, selling, offering to sell, or importing the Par Product.

 

7.                                      In any other or future cause of action or litigation the subject matter of which is a product marketing approval application referencing NDA 201635, Par shall not dispute that all the claims of the Litigated Patents are valid and enforceable in all respects.

 

2

 

8.                                      The foregoing injunctions against Par shall take effect immediately upon entry of this Judgment and Order by the Court, and shall continue until the expiration of the Litigated Patents.

 

9.                                      This Judgment and Order is binding upon and constitutes claim preclusion and issue preclusion with respect to validity and enforceability of the Litigated Patents as asserted in view of the Par Product, and infringement by the Par Product of the Litigated Patents between the Parties in this action or in any action between the Parties.

 

10.                               Par hereby agrees not to aid, abet, assist, enable or participate with any third party in a challenge to the validity or enforceability of the Litigated Patents in any action the subject matter of which is a generic marketing approval referencing NDA 201635, or challenge the infringement by the Par Product.

 

11.                               Nothing herein prohibits or is intended to prohibit Par from making or maintaining a “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (including as amended or replaced) or pursuant to 21 C.F.R. § 314.94(a)(12) (including as amended or replaced) with respect to Par’s Abbreviated New Drug Application No. 205976.

 

12.                               The parties waive all right to appeal from this Judgment and Order.

 

13.                               Each party is to bear its own costs and attorneys fees.

 

3

 

	
SAUL   EWING LLP
    	
 
    	
SAIBER   LLC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Charles M. Lizza
    	
 
    	
Arnold B. Calmann   (abc@saiber.com)
    
	
William C. Baton
    	
 
    	
Jeffrey Soos   (js@saiber.com)
    
	
Sarah A. Sullivan
    	
 
    	
Geri L. Albin   (gla@saiber.com)
    
	
One Riverfront Plaza,   Suite 1520
    	
 
    	
One Gateway Center,   10th Floor, Suite 1000
    
	
Newark, NJ 07102-5426
    	
 
    	
Newark, New Jersey   07102
    
	
clizza@saul.com
    	
 
    	
(973) 622-3333
    
	
wbaton@saul.com
    	
 
    	
 
    
	
ssullivan@saul.com
    	
 
    	
Of Counsel:
    
	
 
    	
 
    	
 
    
	
Of Counsel:
    	
 
    	
Daniel G. Brown (Daniel.Brown@lw.com)
    
	
 
    	
 
    	
Terrence J. Connolly 
    
	
Edgar H. Haug
    	
 
    	
(Terrence.Connolly@lw.com)
    
	
Sandra Kuzmich, Ph.D.
    	
 
    	
Latham &   Watkins LLP 885 Third Avenue
    
	
Elizabeth Murphy
    	
 
    	
New York, New York   10022 (212) 906-1200
    
	
Richard F. Kurz
    	
 
    	
 
    
	
Frommer   Lawrence & Haug LLP
    	
 
    	
Jennifer Koh   (Jennifer.Koh@lw.com)
    
	
745 Fifth Avenue
    	
 
    	
Brittany Merrill Yeng
    
	
New York, NY 10151
    	
 
    	
(Brittany.Yeng@lw.com)
    
	
(212) 588-0800
    	
 
    	
Latham &   Watkins LLP
    
	
ehaug@flhlaw.com
    	
 
    	
12670 High Bluff Drive
    
	
skuzmich@flhlaw.com
    	
 
    	
San Diego, CA 92130
    
	
emurphy@flhlaw.com
    	
 
    	
(858)523-5400
    
	
rkurz@flhlaw.com
    	
 
    	
 
    
	
 
    	
 
    	
Emily C. Melvin   (Emily.Melvin@lw.com)
    
	
Attorneys for Plaintiff
    	
 
    	
Latham &   Watkins LLP
    
	
Supernus   Pharmaceuticals, Inc.
    	
 
    	
330 North Wabash Drive,   Suite 2800
    
	
 
    	
 
    	
Chicago, IL 60606
    
	
 
    	
 
    	
(312) 876-7700
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Attorneys for Defendants Par   Pharmaceutical
    
	
 
    	
 
    	
Companies, Inc. and Par   Pharmaceutical, Inc.
    
	
 
    	
 
    	
 
    
	
SO ORDERED
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Dated:
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
THE   HON. SUSAN D. WIGENTON
    
	
 
    	
 
    	
UNITED   STATES DISTRICT JUDGE

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