Exhibit 10.1

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(c) and 240.24b-2

EXECUTION VERSION

CONFIDENTIAL SETTLEMENT AND LICENSE AGREEMENT

This Confidential Settlement And License Agreement (the “Settlement Agreement”)
is entered into by and among HORIZON THERAPEUTICS, LLC, a corporation organized
and existing under the laws of the State of Delaware with a principal place of
business at 150 S. Saunders Road, Lake Forest, Illinois, 60045 (“Plaintiff”) and
PAR PHARMACEUTICAL, INC. (“Par”), a corporation organized and existing under the
laws of New York with a principal place of business at One Ram Ridge Road,
Chestnut Ridge, NY 10977 (each individually a “Party”, collectively, the
“Parties”), and made effective as of the date upon final execution of the
Settlement Agreement by an authorized representative of each Party (the
“Effective Date”).

WHEREAS Horizon Therapeutics, LLC is the owner of approved New Drug Application
(“NDA”) No. 203284 for RAVICTI® (glycerol phenylbutyrate) Oral Liquid, 1.1
gm/mL;

WHEREAS Horizon Therapeutics, LLC is the owner of U.S. Patent Nos. 8,404,215
(“the ’215 patent”), 8,642,012 (“the ’012 patent”), 9,095,559 (“the ’559
patent”), 9,254,278 (“the ’278 patent”), 9,326,966 (“the ’966 patent”),
9,561,197 (“the ’197 patent”), 9,962,359 (“the ’359 patent”), and 9,999,608
(“the ’608 patent”) (collectively, “the RAVICTI® Patents”), and Plaintiff
represents that they hold all substantial rights to the RAVICTI® Patents;

WHEREAS Par is the owner of ANDA No. 205742 for generic glycerol phenylbutyrate
oral liquid, 1.1 gm/mL;

WHEREAS, Par believes that it is a First Applicant for generic glycerol
phenylbutyrate oral liquid, 1.1 gm/mL and, as such, believes that it is entitled
to the 180 days of marketing exclusivity attendant to 21 U.S.C. §
355(j)(5)(B)(iv);

WHEREAS Plaintiff filed lawsuits against Par in the United States District Court
for the District of Texas, C.A. No. 14-cv-00384-JRG-RSP, the District of New
Jersey, C.A. Nos. 17-

 

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cv-5901-KM-MAH and 16-cv-03910-RBK-JS, and the District of Delaware, C.A. No.
18-cv-01224-RGA (alleging that the filing of ANDA No. 205742 infringes the ’215,
’012, ’559, ’278, ’966, and ’197 patents) (the “Lawsuits”);

WHEREAS Par filed petitions for Inter Partes Review with the Patent Trial and
Appeal Board (“PTAB”) seeking a finding of unpatentability of the ’012 patent
(Case No. IPR2015-01117), the ’215 patent (Case No. IPR2015-01127), the ’559
patent (Case No. IPR2017-01768), the ’278 patent (Case No. IPR2017-01767), the
’966 patent (Case No. IPR2017-01769) and the ’197 patent (Case No.
IPR2018-01550) (the “IPRs”);

WHERAS the PTAB found that Par failed to demonstrate that the ‘012 patent was un
patentable, which decision has been affirmed by the Court of Appeals for the
Federal Circuit, Appeal No. 17-1451 (the “Appeal”);

WHEREAS the Parties wish to avoid the significant legal expense and legal risks
involved in continuing the Lawsuits and the IPRs by settling the Lawsuits and
the IPRs on the terms and conditions set forth in this Settlement Agreement; and

WHEREAS as a result of this Settlement Agreement there may be additional supply
and sales in the Territory of the generic form of RAVICTI® for human use in
advance of the expiration of the RAVICTI® Patents, which supply and sales
otherwise may not have been made until after the expiration of those patents.

NOW, THEREFORE, in consideration of the mutual execution of this Settlement
Agreement and the promises made herein, the Parties agree as follows:

1. Definitions.

a) “Affiliate” of a Party means any person or entity that controls, is
controlled by or is under common control with such Party. As used in this
definition, “control” of an entity

 

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means: (a) in the case of a corporate entity, direct or indirect ownership of at
least fifty percent (50%) of the stock or shares having the right to vote for
the election of directors of such entity; and (b) in the case of a non-corporate
entity, the direct or indirect power to either: (i) direct the management and
policies of the non-corporate entity; or (ii) elect at least fifty percent (50%)
of the members of the governing body of such non-corporate entity.

b) “ANDA” means an abbreviated new drug application (or equivalent regulatory
mechanism, including an application under 21 U.S.C. § 355(b)(2).

c) “Applicable Law” means all applicable provisions of constitutions, statutes,
rules, regulations, ordinances and orders of all Governmental Entities and all
orders and decrees of all courts, tribunals and arbitrators.

d) “Authorized Generic” means a glycerol phenylbutyrate oral liquid product that
is manufactured and sold under the RAVICTI® NDA, but not marketed or sold under
the trademark RAVICTI®.

e) “FDA” means the United States Food and Drug Administration and any successor
agency having the same functions.

f) “Final Decision” means a decision by a court or the U.S. Patent Trial and
Appeal Board that is no longer subject to a right of appeal (other than by a
petition to the United States Supreme Court for a writ of certiorari).

g) “First Applicant” shall have the meaning set forth in 21 U.S.C. §
355(j)(5)(B)(iv)(II) (as amended or replaced).

h) “Generic Product” means a pharmaceutical product which has been approved by
or submitted for approval to FDA under an ANDA or NDA (pursuant to 21 U.S.C. §
355(b)(2))

 

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(as amended or replaced), other than by Plaintiff or their Affiliates, as a
generic version of RAVICTI®.

i) “Governmental Entity” means any (i) nation, state, county, city, town,
village, district, or other jurisdiction of any nature, (ii) federal, state,
local, municipal, foreign, or other government, (iii) governmental or
quasi-governmental authority of any nature (including any governmental agency,
branch, department, official, or entity and any court or other tribunal), (iv)
multi-national organization or body, or (v) body exercising, or entitled to
exercise, any administrative, executive, judicial, legislative, police,
regulatory, or taxing authority or power of any nature.

j) “Licensed Patents” means the RAVICTI® Patents, and any extensions,
divisionals, continuations, continuations-in-part, reissues, reexaminations,
inter partes reviews, amendments thereto, and post-grant reviews thereof, and
any foreign counterparts or equivalents thereof (regardless of whether any claim
of priority is asserted or otherwise exists), and any other patents
prospectively listed in the Orange Book for the NDA Product.

k) “Par ANDA” means ANDA No. 205742 for glycerol phenylbutyrate oral liquid, 1.1
gm/mL as it exists as of the Effective Date, including any future supplements,
amendments and/or modifications to the ANDA that were made to gain approval from
the FDA, provided such supplements, amendments and/or modifications do not
change the active ingredient, dosage form, reference listed drug, or AB rating
of any generic product described in the ANDA as it exists as of the Effective
Date.

l) “Par Generic Product” means the glycerol phenylbutyrate oral liquid, 1.1
gm/mL product described in the Par ANDA.

m) “Manufacture” means to use, make or have made a product.

 

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n) “Market” and “Marketing” means to offer for sale, sell, or distribute a
product.

o) “NDA” means a new drug application (or equivalent regulatory mechanism).

p) “NDA Product” or “RAVICTI®” means the glycerol phenylbutyrate oral liquid
product approved under the RAVICTI® NDA, including any amendments and
supplements thereto.

q) “Officially Discontinue” means any of: (a) delisting the NDA Product with the
FDA; (b) delisting or removing all Licensed Patents, or the NDA Product, from
the FDA’s Orange Book; (c) seeking or otherwise undertaking any action with the
FDA to withdraw the NDA Product from the market; and/or (d) deleting, removing,
designating as “obsolete” or canceling any National Drug Code(s) or any other
relevant code(s) for the NDA Product from the applicable National Drug Data File
maintained by First Databank (or any successor or equivalent organization), or
from any other pricing database.

r) “Orange Book” means the FDA’s publication “Approved Drug Products With
Therapeutic Equivalence Evaluations.”

s) “RAVICTI® NDA” means NDA No. 203284, including any amendments or supplements
thereto (including without limitation any amendments or supplements adding
additional dosage strengths, indications, dosing regimens or other clinical data
or information).

t) “Territory” means the United States of America and its territories,
commonwealths and possessions, including without limitation, the Commonwealth of
Puerto Rico and the District of Columbia.

u) “Third Party” means any person or entity other than the Parties and their
respective Affiliates.

 

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2. Final Dismissal of Litigations. Within […***…] business days of […***…], the
Parties shall enter into and cause to be filed in the Lawsuits a Stipulated
Order of Dismissal and [Proposed] Order in the forms attached as Exhibits A, B
and C to this Settlement Agreement and shall enter into and cause to be filed in
the IPRs a joint request for termination pursuant to 35 U.S.C. § 317 together
with a copy of the Settlement Agreement as required (“Joint Request”), pursuant
to which all claims in the Lawsuits will be dismissed and the IPRs will be
terminated at the discretion of the PTAB without costs or fees, […***…].

3. Agreement Not to Challenge Validity or Enforceability. Par agrees not to seek
review of or contest, in any forum (e.g., U.S. courts, ITC, U.S. Patent and
Trademark Office (e.g., Inter Partes Review, Reexamination, Interference) or
foreign courts or foreign patent offices), the validity or enforceability of the
Licensed Patents nor take any action intended to adversely affect Plaintiff’s
rights in and to the Licensed Patents, except that the foregoing shall not
preclude Par from contesting the validity or enforceability of the Licensed
Patents in connection with any ANDA, NDA, or foreign regulatory submission that
Par files referencing a drug product other than the NDA Product. For the
avoidance of doubt, the foregoing shall not preclude Par from filing and/or
maintaining in the Par ANDA any certifications under 21 U.S.C. §
355(j)(2)(A)(vii)(IV) (as amended or replaced) to any Licensed Patents.

4. Releases.

a) Plaintiff’s Release. Plaintiff, for themselves and their Affiliates, agents,
successors and assigns, does hereby forever release and discharge Par, and any
of its past or present agents, employees, officers, directors, and suppliers,
and any past or present distributors, resellers, purchasers and/or end-users of
products sold or distributed by Par, from any causes of

 

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action, losses, promises, damages, costs, expenses, liabilities and/or demands
of whatsoever character, nature and kind, known or unknown, suspected or
unsuspected, fixed or contingent, arising out of or in any way related to the
Par ANDA, the Par Generic Product or the actions, conduct, omissions, or events
alleged, or which could have been alleged, in the Lawsuits.

b) Par’s Release. Par, for itself and its Affiliates, agents, successors and
assigns, does hereby forever release and discharge Plaintiff, and any of their
past or present agents, employees, officers, directors, Affiliates and
suppliers, and any past or present distributors, resellers, purchasers and/or
end-users of products sold or distributed by Plaintiff from any causes of
action, losses, promises, damages, costs, expenses, liabilities and/or demands
of whatsoever character, nature and kind, known or unknown, suspected or
unsuspected, fixed or contingent, arising out of or in any way related to the
Par ANDA, the Par Generic Product or the actions, conduct, omissions, or events
alleged, or which could have been alleged, in the Lawsuits.

5. License, Waiver and Covenant.

a) Plaintiff hereby grants Par a non-exclusive, perpetual, royalty-free license
under the Licensed Patents to make, have made, use, import, sell and offer for
sale in the Territory the Par Generic Product on and after the License Effective
Date.

b) Plaintiff hereby grants Par a waiver of any regulatory exclusivities
concerning RAVICTI® to which Plaintiff may be entitled and that may prevent
approval of the Par ANDA on or after the License Effective Date, and within
[…***…] business days of Par’s request, Plaintiff shall submit, and/or shall
cause its Affiliates to submit, appropriate and reasonable documentation to the
FDA (in a form acceptable to FDA, together with any other necessary submissions,
all subject to review by Par prior to submission) evidencing the licenses,
covenant not to sue, and waivers set forth in this Agreement.

 

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c) Plaintiff and their Affiliates, on and after the License Effective Date (or
earlier, limited solely to the activities provided in Section 7 of this
Settlement Agreement), hereby covenant not to sue Par and its Affiliates, and
their importers, suppliers, distributors, and customers, or support or encourage
any Third Party to sue, for infringement of any United States or foreign patents
owned, licensed or otherwise controlled, wholly or in part, by Plaintiff and/or
any of their Affiliates purporting to cover the Par Generic Product and/or the
making, using, selling, or offering for sale in the Territory, or making or
having made only for importation, use, sale or offering for sale into or for the
Territory of the Par Generic Product. For the Licensed Patents, the foregoing
covenant not to sue shall hereby be treated as a non-exclusive license to such
patents for the Par Generic Product solely for the purpose of allowing Par
and/or its Affiliates to file and maintain with the FDA a certification pursuant
to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) with respect
thereto. Par shall have the right to maintain its existing certifications under
21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) against the Licensed
Patents. Par also shall have the right to file a certification under 21 U.S.C. §
355(j)(2)(A)(vii)(IV) (as amended or replaced) in connection with the Par
Generic Product against any Licensed Patents, and still be covered by the
covenant not to sue.

d) Upon written request by Par, made no earlier than […***…] days prior to the
License Effective Date, Plaintiff will notify Par in writing of all the then
required labeling information for the NDA Product as reasonably requested.

6. License Effective Date. The License Effective Date for the Par Generic
Product will be the earliest to occur of:

(a) July 1, 2025; or

 

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(b) The entry of a Final Decision holding that all of the then-asserted claims
of the Licensed Patents against a Generic Product are unenforceable, invalid,
unpatentable, or not infringed; or

(c) The date on which the Licensed Patents have all become expired, permanently
abandoned, or delisted from the Orange Book; or

(d) […***…]

(e) The date on which an Authorized Generic is first marketed or sold in the
Territory; or

(f) The date following the Effective Date that is the first day of the quarter
after the quarter in which total number of ex-factory units sold for that
quarter for the NDA Product have declined by more than […***…] percent
([…***…]%) from the Threshold Amount, provided that the decline was not: 1)
caused by a bona fide supply interruption; 2) caused by Plaintiffs changes to
its wholesale distribution model, which effect does not last longer than a
single quarter; or 3) caused by pharmacy benefit manager(s)’, insurer(s)’, or
governmental payers’ utilization management practices, including, but not
limited to, denial of formulary status or listing on a formulary exclusion list,
which effect does not last longer than a single quarter. For the purposes of
this provision, the “Threshold Amount” is […***…], which amount (as well as the
total number of ex-factory units of the NDA Product sold during each quarter
after the Effective Date) shall be reported to Par quarterly for the purposes of
the Parties’ compliance with this provision; or

 

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(g) […***…] business days after the date on which Plaintiff receives notice that
a Generic Product is first sold in the Territory without authorization from
Plaintiff or its Affiliates (by license, sublicense, covenant not to sue or
otherwise) (“Unauthorized Third Party Launch”) after the Effective Date, unless
within […***…] business days from receiving such notice (a) Plaintiff moves for
a temporary restraining order or preliminary injunction prohibiting any further
sale of such Generic Product within the Territory, or (b) Plaintiff enters into
an agreement with the Third Party selling such Generic Product to cease and
desist from the sale of a Generic Product. If Plaintiff does seek a temporary
restraining order or preliminary injunction within such […***…] business day
period, the License Effective Date will be deemed to have occurred on the
earlier of (X) the date that the application for a temporary restraining order
or preliminary injunction is first denied, abandoned or withdrawn (with Par’s
license to remain effective without regard to later action, judicial or
otherwise, on the application), and (Y) […***…] calendar days after the
application for a restraining order or preliminary injunction is filed unless a
temporary restraining order or preliminary injunction is issued against the
Third Party seeking to sell the unauthorized Generic Product before […***…]
calendar days after such application (with the understanding that a subsequent
re-introduction of such Generic Product or an introduction of a different
Generic Product may give rise to the occurrence of a License Effective Date
consistent with this Agreement).

7. Pre-Commercial/Pre-Marketing License. Plaintiff grants to Par a limited
pre-commercialization and pre-marketing license as follows:

a) up to […***…] days prior to the License Effective Date, Par shall have the
right to Manufacture and/or have Manufactured the Par Generic Product in or for,
and/or import or have

 

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imported the Par Generic Product into, the Territory to enable Par to Market the
Par Generic Product in the Territory on or after the License Effective Date;

b) up to […***…] days prior to the License Effective Date, Par shall have the
right to notify potential customers of the upcoming availability of Par Generic
Product;

c) up to […***…] days prior to the License Effective Date, Par shall have the
right to provide non-binding offers to potential customers for the sale of the
Par Generic Product; and

d) up to […***…] days prior to the License Effective Date, Par shall have the
right to enter into binding contracts with customers for the sale of Par Generic
Product.

8. Non-Interference. From and after the Effective Date, unless required by the
FDA for reasons of safety or efficacy, Plaintiff shall not (a) file any citizen
petition or other regulatory submissions with the FDA or any other governmental
agency or take any other action that would interfere with Par’s efforts to:
(i) obtain FDA approval of the Par ANDA; or (ii) Market the Par Generic Product
as of the date and under the terms provided in this Settlement Agreement; or
(b) Officially Discontinue the NDA Product prior to expiration of the Licensed
Patents.

9. Most Favored Nation. In the event that Plaintiff, or any of their Affiliates,
has entered into or enters into after the Effective Date any agreement, license,
sublicense, settlement, covenant, waiver, or other authorization of any kind
with any Third Party for a Generic Product, […***…], Plaintiff will immediately
give Par notice of such agreement (and in no event less than […***…] business
days after entering into such agreement) and this Agreement shall be
automatically amended to include such more favorable terms accordingly.

 

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10. Entire Agreement. This Settlement Agreement constitutes the complete
agreement of the Parties with respect to the subject matter hereof and
supersedes and replaces any prior negotiations, mediations, proposed agreements
or agreements, whether written or oral. This Settlement Agreement may be
modified only by a writing signed by all Parties.

11. Successors and Assigns. Neither this Settlement Agreement nor any of the
rights or obligations hereunder may be assigned, transferred, licensed,
sub-licensed or delegated by either Party, without the prior written consent of
the other Party, such consent not to be unreasonably withheld, except to an
Affiliate of the assigning Party, to an assignee of the RAVICTI® NDA, to an
assignee of the Par ANDA, or to the successor to all or substantially all of the
business or assets of such Party to which this Settlement Agreement relates
(whether by merger, sale of stock, sale of assets or other transaction) that
agrees in writing to be bound by the terms and conditions of this Agreement. Any
permitted successor or assignee of rights and/or obligations hereunder shall, in
a writing to the other Parties, expressly assume performance of such rights
and/or obligations. Any permitted assignment shall be binding on the successors
of the assigning Party. Any assignment or attempted assignment by any Party in
violation of the terms of this paragraph shall be null and void.

12. Confidential Information.

a) Treatment of Confidential Information. During the term of this Settlement
Agreement and continuing thereafter, each Party shall keep confidential and not
disclose to others or use for any purpose, other than as authorized by this
Settlement Agreement, all Confidential Information which was provided to it by
any other Party or its Affiliates or their respective employees or
representatives pursuant to this Settlement Agreement. For purposes of this
Settlement Agreement, the term “Confidential Information” means the terms of
this

 

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Settlement Agreement and any information furnished in connection with this
Settlement Agreement, including without limitation any and all know-how, trade
secrets, formulae, data, inventions, technology and other information, including
manufacturing techniques, processes, trade and financial information, related to
the manufacture, use, sale or marketing of any products that are the subject of
this Settlement Agreement, currently in the possession of, or developed during
the term of the Settlement Agreement by Par, Plaintiff or any of their
respective Affiliates. The restrictions of this Section shall not apply to any
Confidential Information which (i) is already known to the recipient at the time
of disclosure, as reasonably documented by written records; (ii) is or later
becomes public knowledge through no fault of the recipient; (iii) is received
from a Third Party having the lawful right to disclose the information; or
(iv) is independently developed by employees of the recipient without access to
the disclosing Party’s Confidential Information.

b) Permitted Disclosure. A Party may disclose Confidential Information of
another Party to (i) its Affiliates, and to its and their directors, employees,
consultants, attorneys, and agents, in each case who have a specific need to
know such Confidential Information and who are bound by a like obligation of
confidentiality and restriction on use; (ii) any bona fide actual or prospective
collaborators, underwriters, investors, lenders or other financing sources who
are obligated to keep such information confidential, to the extent reasonably
necessary to enable such actual or prospective collaborators, underwriters,
investors, lenders or other financing sources to determine their interest in
collaborating with, underwriting or making an investment in, or otherwise
providing financing to, the receiving Party; and (iii) the extent such
disclosure is required to comply with Applicable Law or to defend or prosecute
litigation, provided, however, that the receiving Party provides prior written
notice of such disclosure under this subsection (iii)

 

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to the disclosing Party and takes reasonable and lawful actions to avoid or
minimize the degree of such disclosure, including upon the disclosing Party’s
request, seeking confidential treatment of such Confidential Information. If a
Governmental Entity directs or recommends to Par that Par transfer the Par ANDA
to a Third Party, Par may disclose a copy of this Settlement Agreement to a
Third Party in connection with such a possible transfer so long as the Third
Party agrees to confidential treatment of this Settlement Agreement. In
addition, Par may disclose the terms of this Settlement Agreement to FDA as may
be necessary to obtain and maintain final approval of the Par ANDA, so long as
Par requests that FDA treat such terms as confidential.

c) Return of Confidential Information. This Settlement Agreement does not
constitute the conveyance of ownership with respect to or a license to any
Confidential Information, except as otherwise provided in this Settlement
Agreement. Upon the expiration or termination of this Settlement Agreement for
any reason, each Party agrees, except as otherwise provided in this Settlement
Agreement, to return to the other Party or destroy (and certify such
destruction) all documentation or other tangible evidence or embodiment of
Confidential Information belonging to the other Party and not to use same,
unless otherwise agreed in writing. The Parties agree and acknowledge that the
foregoing obligation does not apply to Confidential Information recorded on
electronic back-up tapes that are maintained in the ordinary course and are
unreasonably difficult to access.

d) Publicity. No public announcement or other disclosure to Third Parties
concerning the existence or terms of this Settlement Agreement shall be made,
either directly or indirectly, by any Party, without notifying the other Parties
of the nature, text and timing of such announcement or disclosures. Any Party
shall have the right to make any such public announcement or other disclosure,
including disclosures required by applicable regulatory

 

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authorities and listing exchanges, required by Applicable Law after such Party
has provided to the other Party a copy of such announcement or disclosure and a
reasonable opportunity to comment thereon; and provided that Par shall have the
right to inform its customers that Par has obtained a license to sell a Generic
Product in the Territory. Notwithstanding the above, either Party may, without
the permission of the other party, issue a press release disclosing that the
litigation has settled by Par taking a license under the Licensed Patents and
disclosing the License Effective Date set forth in Section 6(a) of this
Settlement Agreement. Each Party agrees that it shall cooperate fully with the
other Parties with respect to all disclosures regarding this Settlement
Agreement to any governmental or regulatory agencies, including requests for
confidential treatment of proprietary information of any Party included in any
such disclosure.

e) Disclosure to Government or in Discovery. Specific terms or conditions of
this Settlement Agreement may be disclosed pursuant to a discovery demand;
subpoena; order of a court, administrative body or arbitrator; or administrative
guidance that in the opinion of a Party’s counsel requires disclosure. If a
Party receives a request to disclose any of the terms or conditions of this
Settlement Agreement pursuant to a discovery demand; subpoena; order of a court,
administrative body or arbitrator; or administrative guidance that in the
opinion of such Party’s counsel requests disclosure, such Party shall notify the
other Parties within […***…] days after receiving such request and at least
[…***…] days prior to disclosing any terms of this Settlement Agreement. Such
Party may then disclose the terms and conditions of this Settlement Agreement
pursuant to such request, provided that it shall have used reasonable efforts to
ensure that such disclosure is subject to a protective order limiting access to
the disclosure to outside counsel and expert witnesses of the entity receiving
the Confidential Information. Nothing herein shall preclude any Party from
complying with an order requiring disclosure, or a guidance

 

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\that in the opinion of such Party’s counsel requires disclosure, of the terms
of this Settlement Agreement that has been issued by a court, arbitrator or
administrative agency of competent jurisdiction. Nothing herein shall prohibit
the Parties from disclosing this Settlement Agreement and its terms to the
Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of
Justice (“DOJ”) pursuant to the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003.

13. Government Review. The Parties agree to submit this Settlement Agreement to
the FTC and the DOJ as required by statute. Each Party shall, to the extent
permitted by law:

a) promptly inform the other Parties of any communication made or received by
such Party to or from any governmental authority regarding this Settlement
Agreement and/or any related agreements; and

b) use reasonable efforts to comply with and terminate any investigation or
inquiry regarding the Settlement Agreement and/or any related agreements by any
government authority, including by providing requested information to such
government authority and permitting reasonable access to its documents,
officials and data related to the Settlement Agreement and/or any related
agreements.

To the extent that any legal or regulatory issues or barriers arise with respect
to the Settlement Agreement, or any subpart thereof, the Parties shall work
together in good faith and use reasonable efforts to modify the Settlement
Agreement to overcome any such legal or regulatory issues (including, for
example, objections by the FTC, 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 Agreement that materially affects the
economic value of the transactions contemplated hereby.

 

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14. Representations and Warranties. Each Party hereby represents, warrants and
covenants to the other Parties as follows:

a) It is a limited partnership, limited liability company, company or
corporation duly organized, validly existing and in good standing under the laws
of the jurisdiction in which it is incorporated or organized, and has full
corporate power and authority and the legal right to own and operate its
property and assets and to carry on its business as it is now being conducted
and as contemplated in this Settlement Agreement, including, without limitation,
the ability to grant the rights granted to the other Parties hereunder.

b) As of the Effective Date: (i) it has the corporate power and authority and
the legal right to have entered into, or enter into, this Settlement Agreement
and perform its obligations hereunder; (ii) it has taken all necessary corporate
action on its part required to authorize the execution and delivery of this
Settlement Agreement and the performance of its obligations hereunder; and
(iii) this Settlement Agreement has been duly executed and delivered on behalf
of such Party and constitutes legal, valid and binding obligations of such Party
that are enforceable against it in accordance with their terms except: (1) as
limited by applicable bankruptcy; insolvency, reorganization, moratorium,
fraudulent conveyance, or other laws of general application relating to or
affecting the enforcement of creditors’ rights generally; and (2) as limited by
laws relating to the availability of specific performance, injunctive relief, or
other equitable remedies.

c) It has not entered, and shall not enter, into any agreement with any Third
Party that is in conflict with the rights granted to the other Parties in this
Settlement Agreement; it has not taken and shall not take any action that would
in any way prevent it from granting the rights granted to the other Parties
under this Settlement Agreement or that would otherwise materially

 

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conflict with or adversely affect the rights granted to the other Parties under
this Settlement Agreement; and its performance and execution of this Settlement
Agreement does not and will not result in a breach of any other contract to
which it is a party.

15. Notice. Any notice required to be delivered under or pursuant to this
Settlement Agreement shall be in writing in the English language, delivered
personally or sent by air mail or express courier service providing evidence of
receipt, postage pre-paid where applicable; or by facsimile (receipt verified),
to the following addresses of the Parties (or such other address for a Party as
it specifies by like notice):

For Horizon Therapeutics, LLC

Brian K. Beeler, Executive Vice-President and General Counsel

Nelson Alexander, Senior Vice-President, Legal

Horizon Therapeutics, LLC

150 S. Saunders Road

Lake Forest, Illinois 60045

For Par Pharmaceutical, Inc.

Par Pharmaceutical, Inc.

Six Ram Ridge Road

Chestnut Ridge, NY 10977

Attn: General Counsel

with a copy to (which will not constitute notice hereunder):

David H. Silverstein

Axinn, Veltrop & Harkrider LLP

114 West 47th Street

New York, NY 10036

Any notice shall be effective upon receipt by the Party to which it is
addressed.

16. No Admission/Representation Regarding Licensed Patents. Plaintiff and Par
agree that this Agreement does not expressly or by implication, estoppel or
otherwise, constitute

 

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(a) an admission by Plaintiff as to the scope or interpretation of the claims of
the Licensed Patents, nor (b) a representation or warranty that the Licensed
Patents are valid and/or enforceable.

17. Governing Law and Venue. This Settlement Agreement shall be governed by, and
construed in accordance with, the laws of the State of New Jersey, without
regard for any conflict of law principles that would dictate the application of
the laws of another jurisdiction. The Parties agree that the United States
District Court for the District of New Jersey shall have exclusive and sole
jurisdiction to enforce any violation of this Settlement Agreement, except that,
if for any reason that Court does not accept jurisdiction, then the state courts
of New Jersey shall have exclusive and sole jurisdiction to enforce any
violation of this Settlement Agreement. The Parties hereby consent to the
personal jurisdiction of those courts for any dispute arising from or relating
to this Settlement Agreement.

18. Severability. If any provision of this Settlement Agreement shall be held by
a court of competent jurisdiction to be illegal, invalid or unenforceable, the
remaining provisions shall remain in full force and effect and the Parties shall
negotiate in good faith to replace the invalid or unenforceable provision with a
valid and enforceable provision that has the effect nearest to that of the
provision to be replaced.

19. Advice of Counsel. This Settlement Agreement has been negotiated by the
Parties and their respective counsel and shall be interpreted fairly in
accordance with its terms and without any strict construction in favor of or
against any Party.

20. No Waiver. Waiver by a Party of any breach of any provision of this
Settlement Agreement by another Party shall not operate or be construed as a
waiver of any subsequent or

 

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other breach. No provision of this Settlement Agreement may be waived except by
a written instrument signed by the Party waiving compliance.

21. Regulatory Delay. No provision of this Settlement Agreement shall be
affected by any delay in the approval of the Par ANDA by the FDA, or the failure
of Par to obtain FDA approval of the Par ANDA.

22. […***…] Expenses, and Costs and Fees. […***…], each Party shall bear its own
attorneys’ fees and costs associated with the Lawsuits and the negotiation and
preparation of this Settlement Agreement.

23. Counterparts. This Settlement Agreement may be executed in one or more
counterparts (including via facsimile or electronic copy), each of which when so
executed and delivered shall be deemed to be an original, but all of which taken
together form but one and the same instrument.

24. Headings. The headings and captions used in this Settlement Agreement are
solely for the convenience of reference and shall not affect its interpretation.

 

 

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25. Interpretation and Construction. The term “including” means “including,
without limitation,” and “herein,” “hereof,” and “hereunder” refer to this
Settlement Agreement as a whole. The word “will” shall be construed to have the
same meaning and effect as the word “shall”. Except as otherwise expressly
provided herein, references to any NDA or ANDA in this Settlement Agreement
shall include such NDA or ANDA as it exists and is comprised as of the Effective
Date, and any replacements or successors or amendments or supplements to any of
the foregoing.

26. Bankruptcy. All licenses and rights to licenses granted under or pursuant to
this Settlement Agreement by Plaintiff to Par are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights
to “intellectual property” as defined under Section 101(35A) of the Bankruptcy
Code. The Parties agree that Par, as a licensee of such rights under this
Settlement Agreement, shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code, and that upon commencement of a bankruptcy
proceeding by or against Plaintiff under the Bankruptcy Code, Par shall be
entitled to a complete duplicate of, or complete access to (as Par deems
appropriate), any such intellectual property and all embodiments of such
intellectual property. Such intellectual property and all embodiments thereof
shall be promptly delivered to Par (a) upon any such commencement of a
bankruptcy proceeding upon written request therefor by Par, unless Plaintiff
elects to continue to perform all of its obligations under this Settlement
Agreement by or on behalf of Plaintiff upon written request therefor by Par or
(b) if not delivered under (a) above, upon the rejection of this Settlement
Agreement by or on behalf of Plaintiff upon written request therefor by Par. The
foregoing provisions are without prejudice to any rights Par may have arising
under the Bankruptcy Code or other applicable law.

 

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IN WITNESS HEREOF, the Parties have caused their duly authorized representatives
to execute this Settlement Agreement to be effective as of the Effective Date.

 

HORIZON THERAPEUTICS, LLC     PAR PHARMACEUTICAL, INC. By:  

/s/ Timothy P. Walbert

    By:  

/s/ Paul Campanelli

Name:   Timothy P. Walbert     Name:   Paul Campanelli

Title:     Chairman, President and Chief Executive Officer

9/17/2018

   

Title:     President & CEO

September 17, 2018

 

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Exhibit A

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

 

    

HORIZON THERAPEUTICS, LLC,

 

                                 Plaintiff,

 

                    v.

 

PAR PHARMACEUTICAL, INC.

 

                                 Defendant.

    

  

    

 

 

Civil Action No. 1:16-cv-03910-RBK-JS

 

 

 

STIPULATION AND [PROPOSED]

ORDER OF DISMISSAL WITHOUT

PREJUDICE PURSUANT TO FED. R.

CIV. P. 41(a)

Pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure,
Plaintiff Horizon Therapeutics, LLC, and Defendant Par Pharmaceutical, Inc.,
hereby stipulate that the above-captioned action, including all claims,
counterclaims and defenses, are hereby dismissed in their entirety without
prejudice.

Date:                         2018

 

John E. Flaherty

Ravin R. Patel

McCARTER & ENGLISH LLP

Four Gateway Center

100 Mulberry St.

Newark, NJ 07102

(973) 622-4444

 

Attorneys for Plaintiff Horizon

Therapeutics, LLC

  

Robert F. Green

Caryn C. Borg-Breen

Emer L. Simic

Ann K. Kotze

GREEN GRIFFITH & BORG-BREEN LLP NBC Tower, Suite 3100

455 North Cityfront Plaza Drive

Chicago, Illinois 60611

(312) 883-8000

 

Of Counsel for Plaintiff Horizon

Therapeutics, Inc.

 

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Jason B. Lattimore

The Law Office Of

JASON B. LATTIMORE, ESQ. LLC

55 Madison Avenue, Suite 400

Morristown, NJ 07960

Telephone: (973) 998-7477

Facsimile: (973) 264-1159

 

Counsel for Defendant Par Pharmaceutical, Inc.

  

David Silverstein

AXINN, VELTROP & HARKRIDER LLP

114 West 47th Street

22nd Floor

New York, NY 10036

dsilverstein@axinn.com

 

Aziz Burgy

AXINN, VELTROP & HARKRIDER LLP

950 F Street, NW

7th Floor

Washington, DC 20004

(202) 912 4700

aburgy@axinn.com

 

Of Counsel for Defendant Par

Pharmaceutical, Inc.

SO ORDERED this ________ day of __________________, 2018.

 

 

THE HONORABLE ROBERT B. KUGLER

UNITED STATES DISTRICT JUDGE

 

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Exhibit B

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

 

 

HORIZON THERAPEUTICS, LLC,

 

Plaintiff,

 

vs.

 

PAR PHARMACEUTICAL, INC.,

 

Defendants.

 

  

 

 

 

Civil Action No. 2:17-cv-5901-KM-MAH

 

 

STIPULATION AND [PROPOSED]

ORDER OF DISMISSAL WITHOUT

PREJUDICE PURSUANT TO FED. R.

CIV. P. 41(a)

Pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure,
Plaintiff Horizon Therapeutics, LLC, and Defendant Par Pharmaceutical, Inc.,
hereby stipulate that the above-captioned action, including all claims,
counterclaims and defenses, are hereby dismissed in their entirety without
prejudice.

Date:                 2018

 

John E. Flaherty

Ravin R. Patel

McCARTER & ENGLISH LLP

Four Gateway Center

100 Mulberry St.

Newark, NJ 07102

Telephone: (973) 622-4444

 

Attorneys for Plaintiff Horizon

Therapeutics, LLC

  

Robert F. Green

Caryn C. Borg-Breen

Ann K. Kotze

Rachel C. Bell

GREEN GRIFFITH & BORG-BREEN LLP

City Place

676 N Michigan Avenue, Suite 3900

Chicago, Illinois 60611

(312) 883-8000

 

Of Counsel for Plaintiff Horizon

Therapeutics, LLC

Jason B. Lattimore

The Law Office Of

JASON B. LATTIMORE, ESQ. LLC

55 Madison Avenue, Suite 400

Morristown, NJ 07960

Telephone: (973) 998-7477

Facsimile: (973) 264-1159

  

David Silverstein

AXINN, VELTROP & HARKRIDER LLP

114 West 47th Street

22nd Floor

New York, NY 10036

dsilverstein@axinn.com

 

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Counsel for Defendant Par Pharmaceutical, Inc.

  

Aziz Burgy

AXINN, VELTROP & HARKRIDER LLP

950 F Street, NW

7th Floor

Washington, DC 20004

(202) 912 4700

aburgy@axinn.com

 

Of Counsel for Defendant Par Pharmaceutical, Inc.

SO ORDERED this ________ day of __________________, 2018.

 

 

THE HONORABLE KEVIN MCNULTY UNITED STATES DISTRICT JUDGE

 

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Exhibit C

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

 

    

HORIZON THERAPEUTICS, LLC,

 

Plaintiff,

v.

 

PAR PHARMACEUTICAL, INC. and PAR

PHARMACEUTICAL COMPANIES, INC.

 

Defendants.

    

  

 

C.A. No. 18-1224-RGA

 

STIPULATION AND

[PROPOSED] ORDER OF

DISMISSAL WITHOUT

PREJUDICE PURSUANT

TO FED. R. CIV. P. 41(a)

Pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure,
Plaintiff Horizon Therapeutics, LLC, and Defendants Par Pharmaceutical, Inc. and
Par Pharmaceutical Companies, Inc., hereby stipulate that the above-captioned
action, including all claims, counterclaims and defenses, are hereby dismissed
in their entirety without prejudice.

Date:                 2018

 

BARNES & THORNBURG LLP

Chad S.C. Stover (no. 4919)

100 N. West Street, Suite 1500

Wilmington, Delaware 19801

Telephone: (302) 300-3474

Email: chad.stover@btlaw.com

 

Attorneys for Plaintiffs Horizon

Therapeutics, LLC

  

Robert F. Green

Caryn C. Borg-Breen

Jessica M. Tyrus

Roy Chamcharas

GREEN GRIFFITH & BORG-BREEN LLP

676 North Michigan Avenue, Suite 3900

Chicago, Illinois 60611

Telephone: (312) 883-8000

 

Of Counsel for Plaintiff Horizon

Therapeutics, LLC

 

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Steven J. Fineman (#4025)

RICHARDS, LAYTON & FINGER, P.A.

One Rodney Square

Wilmington, DE 19899

(302) 651-7700

fineman@rlf.com

 

Counsel for Defendants Par Pharmaceutical,

Inc. and Par Pharmaceutical Companies,

Inc.

  

David Silverstein

AXINN, VELTROP & HARKRIDER LLP

114 West 47th Street

22nd Floor

New York, NY 10036

dsilverstein@axinn.com

 

Aziz Burgy

AXINN, VELTROP & HARKRIDER LLP

950 F Street, NW

7th Floor

Washington, DC 20004

(202) 912 4700

aburgy@axinn.com

 

Of Counsel for Defendant Par Pharmaceutical, Inc. and Par Pharmaceutical
Companies, Inc.

SO ORDERED this ________ day of __________________, 2018.

 

 

THE HONORABLE RICHARD G. ANDREWS UNITED STATES DISTRICT JUDGE

 

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