Document:

Exhibit

Exhibit 10.4

PAYMENT GUARANTY

THIS PAYMENT GUARANTY (this “Guaranty”) is made as of September 26, 2017 by CAREY WATERMARK INVESTORS INCORPORATED, a Maryland corporation having an address at 50 Rockefeller Plaza, 2nd Floor, New York, NY 10020 (“Guarantor”), in favor of W. P. CAREY INC., a Maryland corporation, having an address at 50 Rockefeller Plaza, 2nd Floor, New York, NY 10020 (“Lender”).
RECITALS
A.    Lender has agreed to make one or more loans (collectively, the “Loan”) in the maximum aggregate principal amount outstanding at any one time of up to ONE HUNDRED TWENTY FIVE MILLION and No/100 Dollars ($125,000,000.00) to CWI OP, LP, a Delaware limited partnership (“Borrower”).
B.    The Loan is evidenced by that certain Amended, Restated and Consolidated Promissory Note (the “Note”) dated as of the date hereof and payable to Lender, and is secured by that certain Pledge and Security Agreement, dated as of the date hereof (the “Pledge Agreement”) and delivered by Borrower to Lender encumbering the Collateral (as defined in the Loan Agreement).
C.    The Note, the Loan Agreement the Pledge Agreement and all other documents, instruments and agreements (other than, and specifically excluding, any certificate and indemnity agreement regarding hazardous substances) now in effect or hereafter entered into in connection with the Loan are referred to, collectively, as the “Loan Documents.” 
D.    It is a condition to Lender’s agreement to make the Loan that Guarantor be unconditionally liable for and guarantee the payment and performance of the obligations represented by the Note and all other liabilities and obligations of Borrower under the Loan Documents on the terms and conditions set forth in this Guaranty.
NOW, THEREFORE, in order to induce Lender to make the Loan to Borrower, Guarantor, intending to be legally bound, represents and warrants to Lender and covenants and agrees with Lender as follows:
AGREEMENT
1.Unconditional Guaranty. Guarantor unconditionally, absolutely and irrevocably: (a) guarantees and promises to pay to Lender or order, on demand, in lawful money of the United States of America, in immediately available funds, the Loan when due, whether by acceleration or otherwise, together with all interest thereon, and any and all other amounts that become due and owing to Lender under the Loan Documents (including, without limitation, late charges, premiums for prepayment, expenditures by Lender to preserve and protect collateral, amounts that would become due but for the effect of any bankruptcy or other insolvency proceedings, and all attorneys’ fees, costs and expenses of collection incurred by Lender in enforcing its rights and remedies under the Loan Documents); and (b) guarantees the full and complete discharge and performance of each and every other term, covenant, liability, obligation and warranty contained in the Loan Documents.  All amounts and obligations guaranteed by Guarantor under this Guaranty are referred to, collectively, as the “Guaranteed Obligations.”
2.    Remedies.  If Guarantor fails promptly to perform its obligations under this Guaranty, Lender may from time to time, and without first requiring performance by Borrower or any other Person (as defined in Section 9.2 below) or exhausting any security for the Loan, bring any action at law or in equity or both to compel Guarantor to perform its obligations under this Guaranty, and to collect in any such action compensation for all loss, cost, damage, injury and expense sustained or incurred by Lender as a direct or 

[Payment Guaranty - Borrower Signature Page]

indirect consequence of the failure of Guarantor to perform such obligations, together with interest thereon at the rate of interest applicable to the principal balance of the Note.  Any amounts due under this Section 2 will be in addition to the amounts due under Section 1 of this Guaranty.  This is a guaranty of payment and not merely of collection.  Notwithstanding anything contained in this Guaranty or the other Loan Documents to the contrary, this Guaranty and all obligations of Guarantor arising under it will not be secured by the Pledge Agreement or any other Loan Document.
3.    Rights of Lender.  Guarantor authorizes Lender, without giving notice to Guarantor or obtaining Guarantor’s consent and without affecting the liability of Guarantor, from time to time to:  (a) renew or extend all or any portion of Borrower’s obligations under the Note, the Loan Agreement, the Pledge Agreement or any of the other Loan Documents or delay the enforcement thereof for any period of time; (b) declare all amounts owing to Lender under the Note, the Loan Agreement, the Pledge Agreement and the other Loan Documents due and payable upon the occurrence of an Event of Default (as defined in the Loan Agreement); (c) agree to changes in the dates specified for payment of any amounts payable under the Note, the Loan Agreement or any of the other Loan Documents; (d) otherwise agree to modify, amend, waive, supplement or replace from time to time the terms of any of the Loan Documents in any manner; (e) take and hold security for the performance of Borrower’s obligations under the Note, the Loan Agreement, the Pledge Agreement or the other Loan Documents and exchange, enforce, waive, fail to perfect its interest in, or release any such security; (f) apply such security and direct the order or manner of sale thereof as Lender in its sole discretion may determine; (g) release, substitute or add any one or more indorsers of the Note or guarantors of any or all of the Guaranteed Obligations; and (h) apply payments received by Lender from Borrower or any other Person liable for the Loan to any obligations of the payor to Lender, in such order as Lender may determine in its sole discretion, whether or not any such obligations are covered by this Guaranty; and (i) assignment of this Guaranty in whole or in part. 
4.    Waivers.  Guarantor waives: (a) any defense based upon any legal disability or other defense of Borrower or any other Person, or by reason of the cessation or limitation of the liability of Borrower or any other Person from any cause other than full payment of all of the Guaranteed Obligations; (b) any defense based upon any lack of capacity of Borrower or any lack of authority of the officers, directors, partners, members, managers, trustees, attorneys in fact or agents acting or purporting to act on behalf of Borrower or any principal of Borrower or any defect in the formation of Borrower or any principal of Borrower (and Lender shall have no obligation to inquire into any of the foregoing); (c) any defense based upon the application by Borrower of the proceeds of the Loan for purposes other than the purposes represented by Borrower to Lender or Guarantor or intended or understood by Lender or Guarantor; (d) all rights and defenses arising out of an election of remedies by Lender, even though that election of remedies, such as a nonjudicial foreclosure with respect to security for a Guaranteed Obligation, has destroyed Guarantor’s rights of subrogation and reimbursement against Borrower or any other Person; (e) any defense based upon Lender’s failure to disclose to Guarantor any information concerning Borrower’s financial condition or any other circumstances bearing on Borrower’s ability to pay the Guaranteed Obligations; provided, however, that this waiver shall not extend to any failure by the Company's external advisor, which is an affiliate of Lender, to perform its obligations under its advisory agreement with Borrower; (f) any defense based upon any statute or rule of law providing that the obligation of a surety must be neither larger in amount nor in any other respect more burdensome than that of a principal; (g) any and all claims for subrogation, reimbursement, indemnification or contribution against Borrower, any general partner of Borrower or any other Person or any collateral or security for the Guaranteed Obligations until the Guaranteed Obligations have been indefeasibly paid and satisfied in full; (h) acceptance of this Guaranty by Lender; (i) presentment, demand, protest and notice of any kind; and (j) the benefit of any statute of limitation affecting the liability of Guarantor under, or the enforcement of, this Guaranty.  Guarantor agrees any act or event that tolls any statute of 

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limitation applicable to the Guaranteed Obligations will similarly operate to toll any statute of limitation applicable to Guarantor’s liability under this Guaranty.
5.    Representations, Warranties and Covenants.  Guarantor represents, warrants and acknowledges to and for the benefit of Lender that:  (a) Lender would not make the Loan but for this Guaranty; (b) there are no conditions precedent to the effectiveness of this Guaranty; and (c)  Guarantor has had the opportunity to review the Loan Documents and discuss them with an attorney of Guarantor’s choosing and has done so to Guarantor’s satisfaction or has voluntarily declined to do so.
6.    Additional Covenants.  So long as the Note or any other amount payable by Borrower or Guarantor under the Loan Documents remains unpaid, Guarantor covenants and agrees that:
6.1    Guarantor will repay, or cause the Borrower to repay, to Lender principal and accrued interests under Loan A utilizing the net proceeds received in connection with any sale, disposition, with respect to any direct or indirect interest in any of the subsidiaries of the Borrower, Guarantor or their respective assets (subject to exceptions in relation to maintaining the Guarantor’s REIT compliance, or complying with any tax payment obligations of the Borrower, Guarantor or their respective Subsidiaries (as defined in the Loan Agreement) or as otherwise approved in writing by the Lender); and
6.2    Guarantor will not (with respect to itself or the Borrower) (i) permit a Change of Control (as defined in the Loan Agreement) to occur; or (ii) merge, dissolve, liquidate,  consolidate  with  or  into another Person (as defined in the Loan Agreement), or dispose of (whether in one transaction or in a series of transactions or pledge) all or substantially all of its assets or all of substantially all of the stock of any Subsidiaries to or in favor of any Person.
7.    Subordination.  Guarantor hereby subordinates all present and future obligations and liabilities owing by Borrower to Guarantor to the Guaranteed Obligations.  While any Event of Default exists, Guarantor will enforce such subordinated obligations, and receive payment thereof, only as a trustee for Lender, and Guarantor will promptly pay over to Lender all payments on and other proceeds of such subordinated obligations for application to the Guaranteed Obligations.
8.    Subrogation.  Any rights which Guarantor may have or acquire by way of subrogation, reimbursement, restitution, exoneration, contribution or indemnity, and any similar rights (whether arising by operation of law, by agreement or otherwise), against the Borrower or any other Person, arising from the existence, payment, performance or enforcement of any of the obligations of Guarantor under or in connection with this Guaranty, shall be subordinate in right of payment to the obligations of Borrower to Lender under the Loan Documents, and Guarantor shall not exercise any such rights until all of the obligations of Borrower to Lender under the Loan Documents and all of Guarantor’s obligations under this Guaranty have been paid in cash and performed in full and all commitments to extend credit under, and any and all letters of credit issued under, the Loan Documents shall have terminated.  If, notwithstanding the foregoing, any amount shall be received by Guarantor on account of any such rights prior to such time such amount shall be held by Guarantor in trust for the benefit of Lender, segregated from other funds held by Guarantor, and shall be forthwith delivered to Lender in the exact form received by Guarantor (with any necessary endorsement), to be applied to the Borrower’s obligations to Lender under the Loan Documents, whether matured or unmatured, in such order as Lender may elect, or to be held by Lender as security for the Borrower’s obligations to Lender under the Loan Documents and disposed of by Lender in any lawful manner, all as Lender may elect.

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9.    Disclosure of Information; Participations, Etc.  Guarantor agrees that Lender may elect, at any time, to sell, assign, participate or all or any portion of Lender’s rights and obligations under the Loan Documents.  Guarantor agrees that Lender may disseminate any and all information pertaining to the Property, Borrower, Guarantor or any other guarantor to any relevant Person in connection with any such transaction.
10.    Additional and Independent Obligations. The obligations of Guarantor under this Guaranty are in addition to, and do not limit or in any way affect, the obligations of Guarantor under any other existing or future guaranties.  This Guaranty is independent of the obligations of Borrower under the Note, the Pledge Agreement, the Loan Agreement and the other Loan Documents.  Nothing contained in this Guaranty will prevent Lender from suing to collect on the Note or from exercising concurrently or successively any rights available to it under applicable law or any of the Loan Documents, and that the exercise of any of such rights will not constitute a legal or equitable discharge of Guarantor.  Guarantor hereby authorizes and empowers Lender to exercise, in its sole discretion, any rights and remedies, or any combination thereof, that may then be available, since it is the intent and purpose of Guarantor that the obligations under this Guaranty will be absolute, independent and unconditional under any and all circumstances.  Lender may bring a separate action to enforce the provisions of this Guaranty against Guarantor without taking action against Borrower or any other Person or joining Borrower or any other Person as a party to such action.
11.    Miscellaneous.
11.1    Attorneys’ Fees; Enforcement.  If any attorney is engaged by Lender to enforce or defend any provision of this Guaranty, or any of the other Loan Documents, or as a consequence of any Event of Default under the Loan Documents, with or without the filing of any legal action or proceeding (including any bankruptcy or other insolvency proceeding and including all post-judgment collection proceedings), Guarantor will pay to Lender immediately upon demand all reasonable attorneys’ fees and costs incurred by Lender in connection therewith, together with interest thereon, from the date Lender pays such amounts until they are repaid to Lender, at the rate of interest applicable from time to time to the principal balance of the Note (and if more than one such rate applies to the principal balance at any one time, the highest such rate shall be used for purposes of this Section).
11.2    Certain Definitions and Rules of Construction.  The word “Borrower” as used in this Guaranty includes both the named Borrower and any other Person at any time assuming or otherwise becoming primarily liable for all or any part of the obligations of the named Borrower under the Note, the Pledge Agreement, the Loan Agreement and the other Loan Documents.  If this Guaranty is executed by more than one Person, the term “Guarantor” includes all such Persons.  As used in this Guaranty, the term “Person” means any individual, corporation, limited or general partnership, limited liability company, trust or trustee(s) acting with respect to property held in trust, governmental agency or body, or other legal entity. When the context and construction so require, all words used in the singular will be deemed to have been used in the plural and vice versa.  All headings appearing in this Guaranty are for convenience only and will be disregarded in construing this Guaranty.  All references in this Guaranty to the Note, the Pledge Agreement or any other document include the same as now in effect and as it may be modified, amended, restated, supplemented, extended, replaced or consolidated.
11.3    Captions.  The headings and captions in this Guaranty are for convenience only and shall not affect the interpretation or construction of this Guaranty.

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11.4    Notices.  All notices or other written communications hereunder shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail or sent by telecopy or email, as follows:
(a)    if to Lender, to it at 50 Rockefeller Plaza, 2nd Floor, New York, NY 10020, Attention of Chief Financial Officer; and 
(b)    if to Guarantor, to it at 50 Rockefeller Plaza, New York, New York 10020, Attention of Chief Financial Officer (Telecopy No. 212-492-8922); and
(c)    if to Guarantor, to it at Carey Watermark Investors Inc., 150 North Riverside Plaza, Suite 4200, Chicago, IL 60606 Attention: Michael Medzigian.

Guarantor and Lender Agent may change their addresses or telecopy numbers or email addresses for notices and other communications hereunder by notice to the other party.  All notices and other communications given to Guarantor or Lender in accordance with the provisions of this Guaranty shall be deemed to have been given on the date of receipt, in the case of email notices, as evidenced by sender’s receipt of an acknowledgement from the intended recipient (such as by the “return receipt function”).
11.5    Governing Law.  This Guaranty will be governed by, and construed in accordance with, the laws of the State of New York, without regard to its conflict of laws principles.  
11.6    Service of Process.  Guarantor irrevocably consents to service of process in the manner provided for notices herein.  Nothing in this Guaranty will affect the right of Lender to serve process in any other manner permitted by law.
11.7    Consent to Jurisdiction.  Guarantor hereby irrevocably and unconditionally submits, for itself and its property, to the nonexclusive jurisdiction of any United States Federal or New York State court sitting in the Borough of Manhattan, and any appellate court from any thereof, in any action or proceeding arising out of or relating to this Guaranty, or for recognition or enforcement of any judgment, and Guarantor hereby irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding may be heard and determined in such New York State or, to the extent permitted by law, in such Federal court.  Guarantor hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.  Nothing in this Guaranty shall affect any right that Lender may otherwise have to bring any action or proceeding relating to this Guaranty against Guarantor or its properties in the courts of any jurisdiction.  Guarantor hereby irrevocably and unconditionally waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating to this Guaranty in any court referred to in subsection (b) above.  Guarantor hereby irrevocably waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action or proceeding in any such court.

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11.8     Successors and Assigns.  The provisions of this Guaranty will bind and benefit the heirs, executors, administrators, legal representatives, successors and assigns of Guarantor and Lender.
11.9     Severability.  If any provision of this Guaranty is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable, that portion will be deemed severed from this Guaranty and the remaining parts will remain in full force as though the invalid, illegal or unenforceable portion had never been part of this Guaranty.
11.10     Survival.  This Guaranty will be deemed to be continuing in nature and will remain in full force and effect and will survive the exercise of any remedy by Lender under the Pledge Agreement or any of the other Loan Documents, including, without limitation, any foreclosure or deed in lieu thereof.  This Guaranty will continue to be effective, or be reinstated, as the case may be, if at any time any payment of any of the Guaranteed Obligations is rescinded or otherwise must be returned by Lender due to the insolvency, bankruptcy or reorganization of the payor, or for any other reason, all as though such payment to Lender had not been made.
11.11     Counterparts.  This Guaranty may be executed in counterparts, each of which will be deemed an original, and all such counterparts when taken together will constitute but one agreement.
11.12     Entire Agreement; Amendments.  This Guaranty and the other Loan Documents represent the final expression of the entire agreement of the parties and may not be contradicted by evidence of prior, contemporaneous or subsequent oral agreements. There are no unwritten oral agreements between the parties.  All prior or contemporaneous agreements, understandings, representations and statements, oral or written, are merged into this Guaranty and the other Loan Documents.  Neither this Guaranty nor any of its provisions may be waived, modified, amended, discharged or terminated except by an agreement in writing signed by the party against which the enforcement of the waiver, modification, amendment, discharge or termination is sought, and then only to the extent set forth in that agreement.
11.13      Waiver Of Jury Trial.  EACH OF GUARANTOR AND LENDER (FOR ITSELF AND ITS SUCCESSORS, ASSIGNS AND PARTICIPANTS) WAIVES ITS RIGHT TO A TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION BASED UPON, ARISING OUT OF OR RELATED TO THIS GUARANTY, THE LOAN DOCUMENTS OR THE TRANSACTIONS PROVIDED FOR HEREIN OR THEREIN, IN ANY LEGAL ACTION OR PROCEEDING OF ANY TYPE BROUGHT BY ANY PARTY TO ANY OF THE FOREGOING AGAINST ANY OTHER SUCH PARTY, WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE.  ANY SUCH CLAIM OR CAUSE OF ACTION SHALL BE TRIED BY A COURT SITTING WITHOUT A JURY.

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DATED as of the date first set forth above.
GUARANTOR:
	
		
	Carey Watermark Investors Incorporated, a Maryland corporation

	 
	 

	 
	 

	By:
	/s/ Michael Medzigian

	 
	Name: Michael Medzigian

	 
	Title: Executive Officer

STATE OF NEW YORK    )
) ss.:
COUNTY OF NEW YORK  )

On the 26th day of September, in the year 2017, before me, the undersigned, a Notary Public in and for said state, personally appeared M. Medzigian, personally known to me or proved to me on the basis of satisfactory evidence to be the person(s) whose name(s) is (are) subscribed to the within instrument and acknowledged to me that he/she/they executed the same in his/her/their capacity(ies), and that by his/her/their signature(s) on the instrument, the person(s), or the entity upon behalf of which the person(s) acted, executed the instrument.
	
	
	/s/ Gillian Richards-Deshong

	Notary Public

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Exhibit 10.1

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Settlement and License Agreement

This Settlement and License Agreement (“Agreement”), effective April 12, 2017, is entered into by and between BioMarin Pharmaceutical Inc., a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 770 Lindaro Street, San Rafael, California 94901 (“BioMarin”), Merck & Cie, a Swiss corporation having a principal place of business at Im Laternenacker 5, 8200 Schaffhausen, Switzerland (“Merck”) (together “Plaintiffs”); and Par Pharmaceutical, Inc. (“Par”), a company organized under the laws of Delaware, having a principal place of business at 300 Tice Boulevard, Woodcliff Lake, NJ 07677.  Each of BioMarin, Merck, and Par are individually referred to herein by name or the term “Party” and collectively referred to herein as “Parties.”

WHEREAS, Par has filed Abbreviated New Drug Application Nos. 207200, 207207, and 210027 with the United States Food and Drug Administration (“FDA”) seeking permission to market the Par ANDA Products in the United States and its territories, including the Commonwealth of Puerto Rico (the “Territory”) before the expiration of Plaintiffs’ Orange-Book listed United States Patent Nos. 7,566,462; 7,566,714; 7,612,073; 7,727,987; 7,947,681; 8,003,126; 8,067,416; RE43,797; 9,216,178; 9,433,624 and 8,318,745 (collectively, the “Listed Patents”);

WHEREAS, in response to the filing of ANDA No. 207200, Plaintiffs have filed an action against Par in the United States District Court for the District of New Jersey, captioned BioMarin Pharmaceutical Inc., et al. v. Par Pharmaceutical, Inc., Civil Action No. 15-CV-1706 (MAS)(TJB); and, in response to the filing of ANDA No. 207207, BioMarin has filed an action against Par in the United States District Court for the District of New Jersey, captioned BioMarin Pharmaceutical Inc. v. Par Pharmaceutical, Inc., Civil Action No. 16-CV-1015 (MAS)(TJB) (which actions have been consolidated and are referred to herein together as the “New Jersey Litigation”), alleging infringement of certain of the Listed Patents;

WHEREAS, Par has no present intention of launching the Par ANDA Products without a court order declaring that it does not infringe the Listed Patents, except as provided herein;

WHEREAS, Plaintiffs intend to continue to assert their rights under the Listed Patents to exclude the products described in the Par ANDAs, except as provided herein;

WHEREAS, the Parties wish to fully settle the New Jersey Litigation and all issues concerning the Par ANDA Products upon the terms and subject to the conditions set forth below;

WHEREAS, settlement of the New Jersey Litigation will help Plaintiffs and Par avoid the substantial uncertainty and risk involved with prolonged litigation;

WHEREAS, settlement of the New Jersey Litigation will permit Plaintiffs and Par to save litigation costs, as well as adhere to the judicially-recognized mandate that encourages the settlement of litigation whenever possible;

 

 

WHEREAS, settlement of the New Jersey Litigation will permit the management of Plaintiffs and Par to refocus on running their respective companies rather than devoting substantial time and resources to litigation;

WHEREAS, under this Agreement, Par will have the right to enter the market for sapropterin dihydrochloride tablets and powders several years prior to the expiration of the Listed Patents, thereby benefiting customers by permitting generic entry that may not have occurred were the New Jersey Litigation to proceed; and

WHEREAS, the public will benefit significantly from this final settlement, as it saves judicial resources and creates certainty for Plaintiffs and Par;

NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

Article 1.Definitions.  

For purposes of this Agreement, certain words and their correlatives are defined in Article 1 or in the body of this Agreement.

	
1.1
	
“Affiliate” shall mean any entity which controls, is controlled by, or is under common control with the applicable entity.  For purposes of this definition, “control” shall mean: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares entitled to vote for the election of directors, or otherwise having the power to control or direct the affairs of such entity; and (b) in the case of non-corporate entities, direct or indirect ownership of at least 50% of the equity interest or the power to direct the management and policies of such non-corporate entities.

	
1.2
	
“Authorized Generic Product” means any prescription (for human use) 100 mg strength finished sapropterin dihydrochloride tablet product, 100 mg finished sapropterin dihydrochloride powder product, and/or 500 mg finished sapropterin dihydrochloride powder product manufactured or sold for use in the Territory pursuant to the BioMarin NDAs but not under the Kuvan® trademark.

	
1.3
	
“BioMarin Parties” means BioMarin and its Affiliates; its and its Affiliates’ owners, executives, officers, directors, administrators, successors, or agents; present, past, or future parents; and any successor in interest to or assigns of the Listed Patents.

	
1.4
	
“BioMarin NDAs” means NDA Nos. 22-181 and 205065, as approved by the FDA, and any post-approval supplements thereto.

	
1.5
	
“Claims” means any claims, counterclaims, demands, debts, dues, liabilities, obligations, promises, damages, actions or causes of action of any kind and of whatsoever nature or character, regardless of whether existing in the past or present (or whether accrued, actual, contingent, latent or otherwise), made or brought for the purpose of recovering any damages (including any actual, general, specific, direct, indirect, commercial, 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

		
economic, consequential, incidental, special, punitive, exemplary or treble damages and any loss of revenue, loss of expected profits or expected savings, extradition of infringer’s profits, fines, monetary penalties, court costs, interest, pre judgment and post judgment interest, attorney’s fees, expert fees and any other related costs or expenses). The term “Claims” shall specifically include known or unknown or suspected or unsuspected claims that are based on acts or omissions occurring on or before the Effective Date. 

	
1.6
	
“Dismissal Effective Date” means the date the New Jersey Litigation is dismissed pursuant to the Dismissal Orders.

	
1.7
	
“Dismissal Orders” means the Stipulations of Dismissal attached as Exhibit A to this Agreement.

	
1.8
	
“Effective Date” means the date on which the Agreement was executed by the latest-signing Party, which date is memorialized on page one (1) of this Agreement.

	
1.9
	
“Generic Entry Date” is defined in Article 4 below.

	
1.10
	
“Generic Equivalent” means any prescription (for human use) 100 mg strength finished sapropterin dihydrochloride tablet product, 100 mg finished sapropterin dihydrochloride powder product, and/or 500 mg finished sapropterin dihydrochloride powder product manufactured or sold for use in the Territory under an ANDA as an AB-rated bioequivalent to Kuvan®, under a 505(b)(2) NDA, or as an Authorized Generic Product.

	
1.11
	
“Kuvan®” means the prescription (for human use) 100 mg strength finished sapropterin dihydrochloride tablet product, 100 mg finished sapropterin dihydrochloride powder product, and/or 500 mg finished sapropterin dihydrochloride powder product commercially marketed for use in the Territory under the trademark Kuvan® (or any replacement trademark), and manufactured or sold under the BioMarin NDAs.

	
1.12
	
“Licensed Patents” means (i) Listed Patents and any re-examination, reissue, or patent term extensions thereof or resulting from any post-grant proceedings, including but not limited to any continuations, continuations-in-part, divisional applications, patents, or associated exclusivities thereof; and (ii) any other patents owned or controlled by Plaintiffs (whether currently owned, or developed, obtained, and/or acquired in the future) that would, in the absence of the licenses granted under this Agreement, be infringed by the manufacture, use, importing, offer for sale, or sale by Par of the Par ANDA Products (or their components) in the Territory.

	
1.13
	
“Listed Patents” means United States Patent Nos. 7,566,462; 7,566,714; 7,612,073; 7,727,987; 7,947,681; 8,003,126; 8,067,416; RE43,797; 9,216,178; 9,433,624; and 8,318,745, and any other patents listed by BioMarin, now or at any time in the future, in the FDA’s Orange Book for Kuvan®.

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

	
1.14
	
“Merck” or “Merck Party” means Merck & Cie and its Affiliates; its and its Affiliates’ owners, its executives, officers, directors, administrators, successors, or agents; and any successor in interest to or assigns of the Listed Patents.

	
1.15
	
“Par ANDAs” means ANDA Nos. 207200, 207207, and 210027 as the same may be amended, supplemented, or modified from time to time, or any replacement thereto describing a Generic Equivalent of Kuvan®.

	
1.16
	
“Par ANDA Products” means the prescription (for human use) 100 mg strength finished sapropterin dihydrochloride tablet product, 100 mg finished sapropterin dihydrochloride powder product, and/or 500 mg finished sapropterin dihydrochloride powder product manufactured or sold for use in the Territory under the Par ANDAs as an AB-rated equivalent to Kuvan®.

	
1.17
	
“Par Parties” means Par and its Affiliates; its and its Affiliates’ owners, executives, officers, directors, administrators, successors, or agents; present, past, or future parents; and any successor in interest to or assigns of the Par ANDAs.

	
1.18
	
“Third Party” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, governmental authority, or other entity or organization other than the BioMarin Parties, the Merck Party, or the Par Parties.

	
1.19
	
“Territory” means the United States and its territories, including the Commonwealth of Puerto Rico. 

Article 2.Termination of Litigation.

	
2.1
	
The Parties stipulate to the dismissal of all claims and counterclaims in the New Jersey Litigation without prejudice, with each Party to bear its own fees and costs.

	
2.2
	
Within three (3) business days of the Effective Date, Plaintiffs shall file stipulations of dismissal in the form attached as Exhibit A, so that the New Jersey Litigation is dismissed without prejudice in accordance with Federal Rule of Civil Procedure 41(a)(1).

	
2.3
	
[*] agrees to [*] after the date of this Agreement [*] with respect to [*].  [*] will [*], including [*].  [*] under this provision will [*] under the terms of the [*]

Article 3.Releases.

	
3.1
	
This Agreement settles in full any Claims or causes of action that the Merck Party and BioMarin Parties, on the one hand, and the Par Parties, on the other hand, have against the other relating to the New Jersey Litigation, the Licensed Patents, the Par ANDA Products, and/or the Par ANDAs.

	
3.2
	
In consideration of the mutual execution of this Agreement and upon the terms and subject to the conditions of this Agreement and the Dismissal Orders, BioMarin, on behalf of the BioMarin Parties, and the Merck Party, hereby fully, finally and irrevocably release, acquit and forever discharge the Par Parties and their  customers, importers, 

- 4 –

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

		
manufacturers, distributors, licensors, suppliers, insurers and each of their predecessors and successors from any and all Claims that the BioMarin Parties or the Merck Party have, may have had, might have asserted, may now have or assert, or may hereafter have or assert that are reasonably related to the New Jersey Litigation. Notwithstanding anything in the foregoing to the contrary, the release in this Section 3.2 will not apply to any claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement.

	
3.3
	
In consideration of the mutual execution of this Agreement and upon the terms and subject to the conditions of this Agreement and the Dismissal Orders, Par, on behalf of the Par Parties, hereby fully, finally and irrevocably releases, acquits and forever discharges the BioMarin Parties, the Merck Party, and their respective customers, importers, manufacturers, distributors, licensors, suppliers, insurers and each of their predecessors and successors from any and all Claims that the Par Parties have, may have had, might have asserted, may now have or assert, or may hereafter have or assert that are reasonably related to the New Jersey Litigation.  Notwithstanding anything in the foregoing to the contrary, the release in this Section 3.3 will not apply to any claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement.

Article 4.Grant of a License and Reciprocal Agreement.

	
4.1
	
Subject to the terms and conditions of this Agreement, Plaintiffs hereby grant to Par, and Par hereby accepts, a fully paid up, royalty-free, non-exclusive license, under the Licensed Patents to make, have made, use, import, distribute, have distributed, sell and offer for sale in the Territory the Par ANDA Products (and any of their components) in Par’s or one of its Affiliate’s name only, without the right to grant sub-licenses (provided that Par may retain Third Party contract manufacturers and distributors as necessary to have the Par ANDA Products (and any of their components) made or distributed), as of the Generic Entry Date (as defined below).  Par hereby covenants that the Par Parties shall not (and shall ensure that any of its contract manufacturers and distributors shall not) use any Licensed Patents for a purpose other than that expressly permitted in this Section 4.1.   

	
4.2
	
For purposes of this Agreement, “Generic Entry Date” shall mean the earlier of (i) April 1, 2021, if Par is not entitled to the 180-day first-filer exclusivity period described in 21 U.S.C. § 355(j)(5)(B)(iv); (ii) October 1, 2020, if Par is entitled to the 180-day first-filer exclusivity period described in 21 U.S.C. § 355(j)(5)(B)(iv); (iii) 12:01 a.m. Eastern Time on the day after a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken, holding the then-asserted and adjudicated claims of the Licensed Patents at issue in the case in which such decision is entered to be invalid, unenforceable, or not infringed by a Generic Equivalent (an “Adverse Decision”); or (iv) the earlier of: (a) thirty (30) days after the date that a Third Party commences sales of a Generic Equivalent without permission, license, acquiescence or authorization by BioMarin or its Affiliates (“At Risk Launch”), provided that BioMarin has not obtained by that time a decision or order by any court granting an application for a preliminary or permanent injunction, temporary restraining order, or 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

		
other injunctive or equitable relief with respect to the unlicensed product that is the subject of the Third Party At-Risk Launch; (b) denial of the aforementioned application for a preliminary or permanent injunction, temporary restraining order, or other injunctive or equitable relief; or (c) ten (10) days after an At Risk Launch if BioMarin or its Affiliates fail to seek the aforementioned preliminary or permanent injunction, temporary restraining order, or other injunctive or equitable relief during that ten (10) day period.  If (i) BioMarin obtains a court order from any court requiring the cessation of sales of the unlicensed product that is the subject of the Third Party At-Risk Launch, or (ii) the Third Party ceases sales of the unlicensed product that is the subject of the Third Party At-Risk Launch, by agreement or otherwise, Par will cease any further shipping and sales of the Par ANDA Products until the occurrence of the Generic Entry Date (as determined without reference to such Third Party At-Risk Launch) or such date that is mutually agreed upon, and no other obligation or attendant liability shall otherwise accrue.  

	
4.3
	
[*], (a) as of the Dismissal Effective Date, [*] and [*] necessary to [*] for the purpose of [*], and (b) [*] the Generic Entry Date, [*] in the Territory upon and after the Generic Entry Date.

	
4.4
	
Except as provided in this Agreement Par shall not, directly or indirectly through the Par Parties, or its or their distributors or other Third Parties, (a) [*], offer for sale or accept orders for any of the Par ANDA Products, (b) [*] ship or otherwise deliver to complete the sale of any of the Par ANDA Products, or (c) license, sublicense, enable, permit, or cause (or continue to license, sublicense, enable, permit or cause) any person or entity to do any of the foregoing.  The Parties further agree that any activities in violation of the foregoing provisions of this Article 4 are likely to cause irreparable harm to BioMarin and Merck, and understanding this, Par hereby irrevocably and unconditionally consents to immediate entry of a temporary restraining order, preliminary injunction and permanent injunction in the event such relief is needed to prevent such harm.

	
4.5
	
The rights granted under Section 4.1 do not apply to any patent, patent application, or other intellectual property right owned by or licensed to the BioMarin Parties or the Merck Party other than the Licensed Patents.  Nothing in this Agreement shall preclude BioMarin or Merck from granting any license or sublicense under any or all of the Licensed Patents to make, have made, use, sell, offer for sale, or import a Generic Equivalent, or for any other application.  Except for the rights expressly granted to Par under this Agreement, no other rights under any of the Licensed Patents or any other patents or intellectual property rights of the BioMarin Parties, or the Merck Party are granted under this Agreement, by implication, estoppel or otherwise, and all other such rights are reserved.

	
4.6
	
[*] in the Territory on the Generic Entry Date, BioMarin and its Affiliates [*], including [*] in conjunction with [*], effective as of the Generic Entry Date.  BioMarin and its Affiliates [*], or [*], as appropriate. BioMarin and its Affiliates [*] or [*], or [*] as of the Generic Entry Date.

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

Article 5.Scope of the Parties’ Agreement.

	
5.1
	
Plaintiffs shall have the sole right to prosecute, maintain, enforce, and defend any of the Licensed Patents, according to their respective ownership rights.  The license grant in Section 4.1 does not include any right to sublicense, and Par shall have no such right.

	
5.2
	
Par may not assign or transfer any of its rights or obligations under this Agreement without the prior written consent of Plaintiffs, which consent shall not be unreasonably withheld, conditioned, or delayed, except to an Affiliate of Par or in connection with a merger, reorganization, change of control, or sale of all or substantially all of Par’s business.  Any purported assignment or transfer in violation of the foregoing shall be null and void ab initio and of no force or effect.  No assignment of this Agreement will relieve Par from any of its obligations hereunder.  In the event of a permitted Assignment, this Agreement shall be binding upon and inure solely to the benefit of the Parties and their respective successors and permitted assigns.

Article 6.Warranties and Representations.

	
6.1
	
Each Party hereto represents and warrants to the other Party that, as of the Effective Date, the warranting Party (a) is an entity duly organized, validly existing, and in good standing under the laws of its state of organization; and (b) has full power and authority to enter into and perform its obligations under this Agreement in accordance with its terms.

	
6.2
	
Each Party hereto represents and warrants to the other Party that, as of the Effective Date, this Agreement is a legal, valid, and binding obligation of the warranting Party, enforceable against such Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or by principles of equity.

	
6.3
	
Each Party hereto represents and warrants to the other Party that, as of the Effective Date, the warranting Party is not subject to any judgment, order, injunction, decree, or award of any court, administrative agency, or governmental body that would or might interfere with its performance of any of its material obligations hereunder.

	
6.4
	
BioMarin and its Affiliates hereby covenant not to sue, assert any Claim or otherwise participate in any action or proceeding against, Par and its Affiliates, and its or their importers, manufacturers, suppliers, distributors, and customers, or support or encourage any third Party to sue, for infringement of any Licensed Patent with respect to Par’s making, using, selling, or offering for sale Par ANDA Products in the Territory, or making or having made Par ANDA Products solely for importation, use, sale or offering for sale into and for the Territory, or making, having made, or using the active pharmaceutical ingredient (“API”) for incorporation into the Par ANDA Products.  Notwithstanding anything in the foregoing to the contrary, the covenant in this Section 6.4 will not apply to (i) any Claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement, or (ii) any proceeding with respect to any Par product other than the Par ANDA Products or any patent other than any of the Licensed Patents.

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

	
6.5
	
Par hereby represents and warrants that neither Par, nor any of the Par Parties, will bring or prosecute, nor will any of them assist any Third Party or cooperate with any Third Party in bringing or prosecuting, any judicial, administrative, or other proceeding of any kind challenging the validity or enforceability of any of the Licensed Patents, including but not limited to any post-grant proceeding before the United States Patent & Trademark Office.  Notwithstanding anything in the foregoing to the contrary, the covenant in this Section 6.5 will not apply to (i) any Claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement, or (ii) any proceeding with respect to any Par product other than the Par ANDA Products or any patents other than the Licensed Patents.

	
6.6
	
Except as expressly provided in this Agreement, none of the Parties makes any representations or warranties, express or implied, either in fact or by operation of applicable law.

	
6.7
	
Specifically, Plaintiffs make no representation that, as of the Generic Entry Date, Par will be able to launch the Par ANDA Products.  The Parties herein acknowledge that Par’s ability to launch the Par ANDA Products may be limited by (a) the FDA’s failure to finally approve the Par ANDA Products; (b) a period of exclusivity associated with a Third Party’s “first-filer” status; (c) Par’s inability to manufacture, package, and otherwise prepare a sufficient amount of the Par ANDA Products by the Generic Entry Date; or (d) other situations not currently within the Parties’ contemplation.  Plaintiffs therefore make no warranty and no representation with respect to the actual date that the Par ANDA Products will be available for sale.  Plaintiffs are under no obligation to provide assistance to Par except as explicitly stated in this Agreement.

	
6.8
	
Nothing in this Agreement shall be construed as an admission or representation concerning liability by any Party hereto.

	
6.9
	
Plaintiffs hereby represent, warrant and covenant that, absent a material breach of this Agreement by Par, BioMarin and its Affiliates shall not, and shall not cause any Third Party to, [*], including, but not limited to, [*] or [*] or [*]. 

Article 7.Confidentiality of the Agreement.

	
7.1
	
The Parties shall keep the terms of this Agreement and the underlying settlement confidential.  No Party shall issue or make any public announcement, press release, or other public disclosure regarding this Agreement or the subject matter or terms of the settlement without the other Parties’ prior written consent; however, either Party may disclose or otherwise state publicly that the New Jersey Litigation has been dismissed pursuant to terms that are confidential.  The non-disclosing Parties’ consent shall not be unreasonably withheld or delayed.  

	
 
	
(i)
	
Notwithstanding the first sentence of Section 7.1, a Party may, without prior written consent, disclose: 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

	
 
	
(a) 
	
any information required by a court, governmental agency, or other regulatory authority; 

	
 
	
(b) 
	
any information that is, in the opinion of the disclosing Party’s counsel, required by law or the rules of a stock exchange on which the securities of the disclosing Party are listed; or

(c) any information that a Party is required by pre-existing contract to disclose

to a Third Party; provided that any such disclosure shall be subject to the

Third Party being bound by a confidentiality agreement, at least as strict as

this confidentiality agreement, not to disclose such confidential information.

 

	
 
	
(ii)
	
A Party receiving a request, subpoena, or order for the disclosure of the terms or conditions of this Agreement under Section 7.1(i)(a) shall notify the other Parties as soon as practicable and, if at all possible, in sufficient time to allow the other Parties to oppose disclosure or seek an appropriate protective order.

	
7.2
	
This Agreement and all of the terms herein constitute compromises and offers to compromise covered by Federal Rule of Evidence 408.  Nothing in this Agreement may be used as evidence in any action or proceeding between the Parties hereto, except in connection with any action or proceeding relating to enforcement of this Agreement. 

Article 8.General Provisions.  

	
8.1
	
Each Party shall take or cause to be taken such further actions, and to execute, deliver, and file or cause to be executed, delivered, and filed, such further documents and instruments, and to obtain such consents, as may be reasonably required or requested in order to effectuate fully the purposes, terms, and conditions of this Agreement.

	
8.2
	
The Parties may amend or modify the provisions of this Agreement, including this provision, only by mutual agreement in writing.  

	
8.3
	
No provision of this Agreement shall be waived by any act, omission, or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party.  The failure of any Party to assert its rights under this Agreement or otherwise shall not constitute a waiver of such rights.

	
8.4
	
This Agreement (including all attachments hereto), constitutes the final, complete, and exclusive agreement and understanding of the Parties with respect to the subject matter hereof and supersedes all prior agreements or understandings, oral or written, with respect to such matters.

	
8.5
	
All notices or communications hereunder shall be deemed to have been duly given only if made in writing, served by one of the means listed in Article 8.5(i), and directed to the individuals listed in Article 8.5(ii).

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

	
 
	
(i)
	
Notice or communications to a Party shall be served by personal delivery, reputable overnight express courier service (charged prepaid), or delivery by registered or certified mail (return receipt requested), at the address(es) listed in Section 8.5(ii).  Such notices will be deemed to have been given on the date delivered (in the case of personal delivery or delivery by overnight courier), and on the fifth (5th) business day following the date of postmark in the case of delivery by mail.

	
 
	
(ii)
	
Notice or communications to a Party shall be directed to each of the following:

In the case of BioMarin:

 

 

Jason G. Winchester

Jones Day

77 West Wacker Drive, Suite 3500

Chicago, Illinois  60601

 

G. Eric Davis
Senior VP, General Counsel

BioMarin Pharmaceutical Inc.

105 Digital Drive

Novato, CA 94949

 

 

 

In the case of Merck:

 

Jason G. WinchesterGeneral Manager

Jones DayMerck & Cie

77 West Wacker Drive, Suite 3500Im Laternenacker 5

Chicago, Illinois  606018200 Schaffhausen

Switzerland

 

In the case of Par:

 

Richard J. BermanPar Pharmaceutical, Inc.

Arent Fox LLPOne Ram Ridge Road

1717 K Street, NWChestnut Ridge, New York 10977

Washington, DC 20006Attn: General Counsel

(202) 857-6000Fax: (845) 573-5600

Email: Richard.Berman@arentfox.com

 

	
8.6
	
This Agreement may be executed in any number of counterparts, and execution by each of the Parties of any one of such counterparts will constitute due execution of this Agreement.  Each such counterpart hereof shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement.

	
8.7
	
Electronic execution and delivery of this Agreement by any Party shall be legal, valid, and binding to the same extent as an original signature.

	
8.8
	
If any provision of this Agreement is held invalid, illegal, or unenforceable for any reason, this holding shall not impair the validity, legality, and enforceability of the remaining provisions in any way.  The Parties shall renegotiate in good faith any 

- 10 –

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

Exhibit 10.1

		
provision held to be invalid, illegal, or unenforceable, it being the intent of the Parties that the basic purposes of the Agreement are to be effectuated.

	
8.9
	
Each Party acknowledges that a breach of this Agreement will cause the non-breaching Party to suffer irreparable harm for which there is no adequate legal remedy.  Each Party acknowledges that immediate injunctive relief is an appropriate and necessary remedy for any violation or threatened violation of this Agreement.

	
8.10
	
No Third Party shall be deemed an intended beneficiary hereunder or have any legal or equitable rights or benefits to enforce any provision of this Agreement.

	
8.11
	
None of the Parties hereto shall be considered the drafter of this Agreement or any provision thereof for the purpose of any statute, case law, or rule of construction that would or might cause any provision to be construed against the drafter thereof.

	
8.12
	
This Agreement has been negotiated between unrelated Parties who are sophisticated and knowledgeable in the matters contained in this Agreement and who have acted of their own self-interest.  In addition, each Party has been represented and advised by legal counsel regarding the terms of this Agreement.

	
8.13
	
The Parties are independent contractors and are not, and shall not represent themselves as, principal and agent, partners, joint venturers, or business associates of any kind.  No Party shall attempt to act, or represent itself as having the power, to bind the other Parties or create any obligation on behalf of the other Parties.  Similarly, nothing in this Agreement shall constitute or be construed as Plaintiffs’ endorsement or approval of the Par ANDA Products.  Par, and any Third Party acting in concert with Par, shall not represent or suggest otherwise in any way, including in any labeling, promotional, or marketing material associated with the Par ANDA Products.

	
8.14
	
Mistakes of fact or law shall not constitute grounds for modification, avoidance, or rescission of the terms of this Agreement.

	
8.15
	
Each Party shall bear its own expenses that arise out of the New Jersey Litigation and/or the negotiation, execution, or performance of this Agreement. 

	
8.16
	
This Agreement and any dispute arising out of or related to this Agreement shall be governed by and construed in accordance with the internal laws of the State of New Jersey, without giving effect to conflicts of law principles.  With respect to any proceeding related to this Agreement, each Party irrevocably agrees and consents to the exclusive jurisdiction of the federal and state courts in New Jersey, and waives any objection to venue of any such proceeding brought in any such court.  

Article 9.Term.

	
9.1
	
This Agreement shall continue in force until the expiration of the last of the Licensed Patents (the “Term”).

 

 

Article 10.Filings with the FTC and DOJ.  

	
10.1
	
Within ten (10) business Days following the Effective Date, each Party shall file or cause to be filed with the U.S. Federal Trade Commission Bureau of Competition (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) this Agreement and any notifications required to be filed pursuant to Title XI of the Medicare Prescription Drug Improvement and Modernization Act (Subtitle B - Federal Trade Commission Review) signed into law on December 8, 2003, and any other Applicable Law.  

	
10.2
	
The Parties shall each use all commercially reasonable efforts to coordinate the foregoing filings and any responses thereto, to make such filings promptly and to respond promptly to any requests for additional information made by either of such agencies.  Each Party reserves the right to communicate with the FTC or DOJ regarding such filings as it reasonably believes appropriate.  Each Party shall keep the other reasonably informed of such communications.  

	
10.3
	
If a court of competent jurisdiction determines that one or more provisions of the Agreement violate any applicable law or regulations, then such provision(s) shall become null and void and, therefore, unenforceable.  If a provision is voided by this process, the Parties shall promptly meet and, in good faith, use commercially reasonable efforts to re-negotiate the voided provision(s).  The Parties shall negotiate in good faith concerning any necessary revisions to this Agreement for a period of [*] from the date of the issuance of the court ruling described in this Section 10.3.  If, at the conclusion of this thirty-day period, the Parties are unable to agree to a revised provision, each Party shall [*]

	
10.4
	
In the event that either Party [*] in accordance with Section 10.3, Plaintiffs shall [*], and Par shall [*].  In the event that [*], the Parties will [*]. 

 

 

 

[Signatures on the following pages]

 

 

- 12 –

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

This Agreement is signed as indicated below by duly authorized representatives of BioMarin, Merck, and Par, respectively, as of the Effective Date.

 

BioMarin Pharmaceutical Inc.

 

 

By: /s/ G. Eric Davis

 

Name: G. Eric Davis

 

Title: EVP, General Counsel

 

 

 

 

 

 

 

Merck & Cie

 

 

By: /s/ Dr. Rudolf Moser

 

Name: Dr. Rudolf Moser

 

Title: Managing Director

 

 

 

By: /s/ Markus Wutscher

 

Name: Markus Wutscher

 

Title: Chief Financial Officer

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

 

 

Par Pharmaceutical, Inc.

 

 

By: /s/ Lawrence M. Brown

 

Name: Lawrence M. Brown

 

Title:  Vice President and Asst. General Counsel, IP - Genetics

 

 

 

 

 

 

 

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

 

Exhibit A

Charles M. Lizza

William C. Baton

Sarah A. Sullivan

Saul Ewing LLP

One Riverfront Plaza

Newark, New Jersey  07102-5426

(973) 286-6700

clizza@saul.com

wbaton@saul.com

ssullivan@saul.com

 

Attorneys for Plaintiff

BioMarin Pharmaceutical Inc.

 

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

 

		
	
BioMarin Pharmaceutical Inc., 

Plaintiff,

v.

PAR PHARMACEUTICAL, INC.,

Defendant.
	
 

Civil Action No. 15-1706 (MAS)(TJB)

 

(Filed Electronically)

 

Hon. Michael Shipp, U.S.D.J.

Hon. Tonianne J. Bongiovanni, U.S.M.J.

 

 

 

STIPULATION AND ORDER OF DISMISSAL WITHOUT PREJUDICE

Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, BioMarin Pharmaceutical Inc. (“BioMarin”) and Par Pharmaceutical, Inc. (“Par”) hereby stipulate and agree that all claims, counterclaims, and affirmative defenses asserted by Plaintiffs and Par against each other in the above-captioned consolidated action are hereby dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any Party.

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

		
		
	

Dated: April__, 2017

 

By:  s/ Charles M. Lizza

Charles M. Lizza

William C. Baton

Sarah A. Sullivan

Saul Ewing LLP

One Riverfront Plaza

Newark, New Jersey  07102-5426

(973) 286-6700

clizza@saul.com

wbaton@saul.com

ssullivan@saul.com

 

Of Counsel:

 

Jason G. Winchester

Timothy J. Heverin

Matthew J. Hertko
Jones Day 
77 West Wacker, Suite 3500
Chicago, IL 60601-1692
(312) 782-3939

 

Anthony M. Insogna

Jones Day 
12265 El Camino Real, Suite 200
San Diego, CA 92130-4096
(858) 314-1200

 

Attorneys for Plaintiff
BioMarin Pharmaceutical Inc.

 
	
 

 

By:   s/ Sean R. Kelly

Sean R. Kelly (srk@saiber.com)

Katherine A. Escanlar

(kescanlar@saiber.com)

Saiber LLC

18 Columbia Turnpike

Suite 200

Florham Park, NJ 07932

(973) 645-4801

 

Of Counsel:

 

Richard J. Berman

(richard.berman@arentfox.com)

Janine A. Carlan

(janine.carlan@arentfox.com)

Bradford C. Frese

(bradford.frese@arentfox.com)

Ahmed Abdel-Rahman (ahmed.abdelrahman@

arentfox.com)

ARENT FOX LLP

1717 K Street NW

Washington, DC 20036-5342

(202) 857-6000

 

Attorneys for Defendant

Par Pharmaceutical, Inc.

 

 

 

IT IS on this ____ day of _______________, 2017:

 

SO ORDERED:

 

 

HON. MICHAEL SHIPP, U.S.D.J.

- 2 -

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Charles M. Lizza

William C. Baton

Sarah A. Sullivan

Saul Ewing LLP

One Riverfront Plaza

Newark, New Jersey  07102-5426

(973) 286-6700

clizza@saul.com

wbaton@saul.com

ssullivan@saul.com

 

Attorneys for Plaintiff

BioMarin Pharmaceutical Inc. 

 

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

 

		
	
BioMarin Pharmaceutical Inc., 

Plaintiff,

v.

PAR PHARMACEUTICAL, INC.,

Defendant.
	
 

Civil Action No. 16-1015 (MAS)(TJB)

 

(Filed Electronically)

 

Hon. Michael Shipp, U.S.D.J.

Hon. Tonianne J. Bongiovanni, U.S.M.J.

 

 

STIPULATION AND ORDER OF DISMISSAL WITHOUT PREJUDICE

Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, BioMarin Pharmaceutical Inc. (“BioMarin”) and Par Pharmaceutical, Inc. (“Par”) hereby stipulate and agree that all claims, counterclaims, and affirmative defenses asserted by BioMarin and Par against each other in the above-captioned action are hereby dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any Party.

 

 

- 3 -

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

		
		
	

Dated: April__, 2017

 

By:  s/ Charles M. Lizza

Charles M. Lizza

William C. Baton

Sarah A. Sullivan

Saul Ewing LLP

One Riverfront Plaza

Newark, New Jersey  07102-5426

(973) 286-6700

clizza@saul.com

wbaton@saul.com

ssullivan@saul.com

 

Of Counsel:

 

Jason G. Winchester

Timothy J. Heverin

Matthew J. Hertko
Jones Day 
77 West Wacker, Suite 3500
Chicago, IL 60601-1692
(312) 782-3939

 

Anthony M. Insogna

Jones Day 
12265 El Camino Real, Suite 200
San Diego, CA 92130-4096
(858) 314-1200

 

Attorneys for Plaintiff
BioMarin Pharmaceutical Inc. 
	
 

 

By:   s/ Sean R. Kelly

Sean R. Kelly (srk@saiber.com)

Katherine A. Escanlar

(kescanlar@saiber.com)

Saiber LLC

18 Columbia Turnpike

Suite 200

Florham Park, NJ 07932

(973) 645-4801

 

Of Counsel:

 

Richard J. Berman

(richard.berman@arentfox.com)

Janine A. Carlan

(janine.carlan@arentfox.com)

Bradford C. Frese

(bradford.frese@arentfox.com)

Ahmed Abdel-Rahman (ahmed.abdelrahman@

arentfox.com)

ARENT FOX LLP

1717 K Street NW

Washington, DC 20036-5342

(202) 857-6000

 

Attorneys for Defendant

Par Pharmaceutical, Inc.

 

 

 

IT IS on this ____ day of _______________, 2017:

 

SO ORDERED:

 

 

HON. MICHAEL SHIPP, U.S.D.J.

 

 

- 4 -

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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