Exhibit 10.1

 

EXECUTION COPY

 

CONFIDENTIAL SETTLEMENT AND LICENSE AGREEMENT

 

This Confidential Settlement And License Agreement (the “Settlement Agreement”)
is made effective as of May 10, 2018 (the “Effective Date”) by and among Valeant
Pharmaceuticals International, inc., a Canadian corporation with its United
States headquarters at 400 Somerset Corporate Boulevard, Bridgewater, New Jersey
08807 (“Valeant”), SALIX PHARMACEUTICALS, INC., a California corporation with
its principal place of business at 8510 Colonnade Center Drive, Raleigh, North
Carolina 27615 (“Salix”), PROGENICS PHARMACEUTICALS, INC., a Delaware
corporation with its principal place of business at 777 Old Saw Mill River Road,
Tarrytown, New York 10591 (“Progenics”), and Wyeth LLC, a Delaware limited
liability company with its principal place of business at 235 East 42nd Street,
New York, New York 10017 (“Wyeth”) (Wyeth, collectively with Valeant, Salix and
Progenics, “Plaintiffs”) and PAR STERILE PRODUCTS, LLC (“Par Sterile”), a
Delaware limited liability company, with a place of business at 6 Ram Ridge
Road, Chestnut Ridge, New York 10977, PAR PHARMACEUTICAL, INC. (“Par
Pharmaceutical”), a New York corporation, with a place of business at One Ram
Ridge Rd, Chestnut Ridge, New York 10977. (Par Sterile and Par Pharmaceutical,
collectively, “Par”) (each individually a “Party”, collectively, the “Parties”).

 

WHEREAS Salix is the registered holder of U.S. Food & Drug Administration
approved New Drug Application (“NDA”) No. 021964 for Relistor® (methylnaltrexone
bromide) Injection, for subcutaneous use, 8 mg/0.4 mL methylnaltrexone bromide
in single-dose pre-filled syringe and 12 mg/0.6 mL methylnaltrexone bromide in a
single-dose pre-filled syringe or single-dose vial (“Relistor® Injection”);

 

 

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WHEREAS Progenics is the owner of U.S. Patent Nos. 8,552,025 (“the ’025 Patent”)
and 9,669,096 (“the ’096 Patent”), and Wyeth is the owner of U.S. Patent Nos.
8,247,425 (“the ’425 Patent”), 8,420,663 (“the ’663 Patent”), 8,822,490 (“the
’490 Patent”), 9,190,125 (“the ’125 Patent”), and U.S. Patent No. 9,492,445
(“the ’445 Patent”), and Plaintiffs hold all substantial rights to the ’025,
’096, ’425, ’663, ’490, ’125, and ’445 Patents;

 

WHEREAS Par Sterile is the owner of ANDA No. 209682 for generic methylnaltrexone
bromide injection, for subcutaneous use, 12 mg/0.6 mL methylnaltrexone bromide
in a single-dose vial;

 

WHEREAS Plaintiffs have filed a lawsuit against Par Sterile and Par
Pharmaceutical in the United States District Court for the District of New
Jersey, Civil Action No. 17-06449-SRC-CLW, alleging that the filing of ANDA No.
209682 infringes the ’025, ’096, ’425, ’663, ’490, ’125, and ’445 Patents (the
“Lawsuit”);

 

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

 

WHEREAS as a result of this Agreement there may be additional supply and sales
in the Territory of the generic form of Relistor® Injection for human use in
advance of the expiration of the ’025, ’096, ’425, ’663, ’490, ’125, and ’445
Patents, which supply and sales otherwise may not have been made until after the
expiration of such patents.

 

 

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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 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).

 

(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 generic version of the NDA Product that is
Marketed or intended for Marketing in the Territory under the Salix NDA without
the Relistor® trademark (or any replacement trademark).

 

(e)     “Salix NDA” means NDA No. 021964 for Relistor® Injection, for
subcutaneous use, 8 mg/0.4 mL methylnaltrexone bromide in single-dose pre-filled
syringe and 12 mg/0.6 mL methylnaltrexone bromide in a single-dose pre-filled
syringe or single-dose vial.

 

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

 

(g)     “Final Court 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).

 

 

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(h)     “Generic Vial Product” means a pharmaceutical product that has been
approved by or submitted for approval to FDA under an ANDA as a generic version
of Relistor® Injection, for subcutaneous use, 12 mg/0.6 mL methylnaltrexone
bromide in a single-dose vial.

 

(i)     “Generic PFS Product” means a pharmaceutical product that has been
approved by or submitted for approval to FDA under an ANDA as a generic version
of Relistor® Injection, for subcutaneous use, 8 mg/0.4 mL or 12 mg/0.6 mL
methylnaltrexone bromide in a single-dose pre-filled syringe.

 

(j)     “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.

 

(k)     “Licensed Patents” means U.S. Patent No. 8,552,025 B2, U.S. Patent No.
9,669,096 B2, U.S. Patent No. 8,247,425 B2, U.S. Patent No. 8,420,663 B2, U.S.
Patent No. 8,822,490 B2, U.S. Patent No. 9,190,125 B2, and U.S. Patent No.
9,492,445 B2 and any extensions, pediatric exclusivities, divisionals,
continuations, continuations in part, divisionals, reissues, reexaminations,
inter partes reviews, 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 currently or
prospectively listed in the Orange Book for the NDA Product

 

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

 

 

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

 

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

 

(o)   “NDA Product” or “Relistor® Injection” means the 8 mg/0.4 mL
methylnaltrexone bromide in single-dose pre-filled syringe and 12 mg/0.6 mL
methylnaltrexone bromide in a single-dose pre-filled syringe or single-dose vial
products approved under the Salix NDA.

 

(p)    “Officially Discontinue” means any of: (a) delisting the NDA Product with
the FDA; (b) delisting or removing any 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 other than actions to
withdraw in response to toxicity, efficacy, or other safety concerns associated
with the NDA Product; 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.

 

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

 

(r)     “Par ANDA” means: (i) ANDA No. 208757 for 12 mg/0.6 mL methylnaltrexone
bromide in a single-dose vial product; and (ii) any ANDA filed by Par for 8
mg/0.4 mL and/or 12 mg/0.6 mL methylnaltrexone bromide in a single-dose
pre-filled syringe for which Relistor® Injection is the Reference Listed Drug,
and, with respect to (i) and (ii), including any amendments, replacements, or
supplements that have been made or may in the future be made thereto. For
clarity, “supplements” or “replacements” means with respect to an ANDA for 12
mg/0.6 mL methylnaltrexone bromide in a single-dose vial product for which
Relistor® Injection is the Reference Listed Drug.

 

 

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(s)     “Par Vial Product” means the 12 mg/0.6 mL methylnaltrexone bromide in a
single-dose vial product described in the Par ANDA.

 

(t)     “Par PFS Product” means the 8 mg/0.4 mL or 12 mg/0.6 mL methylnaltrexone
bromide in a single-dose pre-filled syringe product described in the Par ANDA.

 

(u)     “Proceeding” means any administrative, judicial or legislative action,
audit, litigation, investigation, suit or other proceeding in any tribunal.

 

(v)    “Section 505(b)(2) Applicant” means any person or entity that has sought
approval or has received approval from the FDA under an NDA pursuant to 21
U.S.C. § 355(b)(2) (as amended or replaced) of 8 mg/0.4 mL methylnaltrexone
bromide in Single-dose Pre-filled Syringe or 12 mg/0.6 mL methylnaltrexone
bromide in a Single-dose Pre-filled Syringe or Single-dose Vial products.

 

(w)   “Single-dose Pre-filled Syringe” means for subcutaneous use, 8 mg/0.4 mL
methylnaltrexone bromide in single-dose pre-filled syringe and 12 mg/0.6 mL
methylnaltrexone bromide in a single-dose pre-filled syringe.

 

(x)     “Single-dose Vial” means for subcutaneous use, 12 mg/0.6 mL
methylnaltrexone bromide in a single-dose vial.

 

(y)     “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.

 

 

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

 

2.       Final Dismissal of Litigation. Within five (5) business days of the
Effective Date, the Parties shall enter into and cause to be filed in the
Lawsuit a Stipulated Consent Judgment and Injunction in the form attached as
Exhibit A to this Settlement Agreement. Each Party acknowledges and agrees that
the 30-month stay imposed by FDA in relation to the approval of the Par ANDA
under 21 U.S.C. § 355(j)(5)(B)(iii) should be terminated. Plaintiffs agree to
cooperate with Par in communicating with the FDA regarding the termination of
the 30-month stay, including in the submission of any necessary forms or other
documents in order to effectuate the termination of the stay.

 

3.       Acknowledgement of Validity/Enforceability/Infringement and Agreement
Not to Challenge Validity or Enforceability. Par acknowledges, agrees and admits
that, in connection with the Par Vial Product, the Par PFS Product, and the Par
ANDA only, the Licensed Patents are valid and enforceable and that the
manufacture, use, sale or importation of the Par Vial Product and the Par PFS
Product infringes one or more claims of the ’025, ’096, ’425, ’663, ’490, ’125,
and ’445 Patents. In connection with the Par Vial Product, the Par PFS Product,
and the Par ANDA only, Par agrees not to contest the patentability, validity, or
enforceability of the Licensed Patents in any forum in the Territory, or take
any action intended to adversely affect Plaintiffs’ rights in and to the
Licensed Patents. For the avoidance of doubt, the foregoing shall not preclude
Par from maintaining in the Par ANDA any certifications under 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV) (as amended or replaced) to any patents listed in the
Orange Book in connection with the Salix NDA, or from challenging the validity,
enforceability and/or infringement of the Licensed Patents in any action or
proceeding that involves a Par product or ANDA other than the Par Vial Product,
the Par PFS Product, and the Par ANDA. Notwithstanding the above, should
Plaintiffs allege in a Proceeding that Par infringes of one or more of the
Licensed Patents by (i) the filing by Par of an ANDA other than the Par ANDA; or
(ii) the selling of a product other than the Par Vial Product or the Par PFS
Product, then Par will not be prohibited from challenging the patentability (in
any Proceeding) of such Licensed Patents that Plaintiffs allege are infringed by
Par.

 

 

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4.        Releases.

 

(a)     Plaintiffs’ Release. Plaintiffs, for themselves and their agents,
successors and assigns, do hereby forever release and discharge Par, and any of
its past or present agents, employees, officers, directors, attorneys 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 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
actions, conduct, omissions, or events alleged, or which could have been
alleged, in the Lawsuit.

 

(b)     Par’s Release. Par, for itself and its agents, successors and assigns,
does hereby forever release and discharge Plaintiffs, and any of their past or
present agents, employees, officers, directors, attorneys and suppliers, and any
past or present distributors, resellers, purchasers and/or end-users of products
sold or distributed by Plaintiffs 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 actions, conduct,
omissions, or events alleged, or which could have been alleged, in the Lawsuit.

 

 

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5.        License and Covenant.

 

(a)     Subject to Section 5(d) below, Plaintiffs hereby grant Par a
non-exclusive, royalty-free non-transferable, non-sublicensable, limited license
under the Licensed Patents to make, have made, use, import, sell and offer for
sale in the Territory the Par Vial Product and the Par PFS Product on and after
the License Effective Date. Par’s limited license to make or have made outside
of the Territory is only for importation of the Par Vial Product and the Par PFS
Product into the Territory. For avoidance of doubt, Par understands and agrees
that it does not have a license under the Licensed Patents to make or have the
Par Vial Product and the Par PFS Product made outside the Territory for any
other purpose than for importation into the Territory.

 

(b)     The “License Effective Date” shall be the earliest of

 

(i) September 30, 2030;

 

(ii) (x) for the Par Vial Product, 181 days after any Third Party, who is the
“First Applicant”, as that term is defined in 21 U.S.C. § 355(j)(5)(B)(iv)(II)
(as amended or replaced), Markets a Generic Vial Product in the Territory or (y)
for the Par PFS Product, 181 days after any Third Party, who is the “First
Applicant”, Markets a Generic PFS Product in the Territory, provided that the
First Applicant for purposes of (x) or (y) has not forfeited, relinquished, or
otherwise waived its Hatch-Waxman exclusivity as described in 21 U.S.C.
§ 355(j)(5)(B)(iv)(II)(aa) (as amended or replaced) (“180-day exclusivity”);

 

(iii) (x) for the Par Vial Product, the date on which a Single-dose Vial
Authorized Generic is first Marketed in the Territory by a Third Party (not a
First Applicant) or (y) for the Par PFS Product, the date on which a Single-dose
Pre-filled Syringe Authorized Generic is first Marketed in the Territory by a
Third Party (not a First Applicant);

 

 

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(iv) (x) for the Par Vial Product, the date on which a Third Party who is not a
First Applicant, or who is a First Applicant but has forfeited, relinquished or
otherwise waived its 180-day exclusivity, Markets, or is first authorized by
Plaintiffs to begin Marketing, a Generic Vial Product in the Territory or (y)
for the Par PFS Product, the date on which a Third Party who is not a First
Applicant, or who is a First Applicant but has forfeited, relinquished or
otherwise waived its 180-day exclusivity, Markets, or is first authorized by
Plaintiffs to begin Marketing, a Generic PFS Product in the Territory;

 

(v) the date on which a Final Court Decision is entered holding that each of the
asserted claims against Par in the Lawsuit from the ’025, ’096, ’425, ’663,
’490, ’125, and ’445 Patents are (A) adjudicated invalid, unpatentable, and/or
unenforceable or (B)(1) for the Par Vial Product, found not infringed; or

 

(vi) the date on which the ’025, ’096, ’425, ’663, ’490, ’125, and ’445 Patents
have expired, been permanently abandoned, or delisted from the Orange Book. In
the event Plaintiffs become aware of the actual date under (ii), (iii) or (iv)
above, it shall give Par notice of such date and, to the extent practicable, at
least 180 days prior to such date. With respect to (iii), (iv), and (v), Par’s
“License Effective Date” is still subject to any First Applicant rights to the
extent that the First Applicant has not forfeited, relinquished, or otherwise
waived its Hatch-Waxman exclusivity as described in 21 U.S.C. § 355(j)(5)(B)(iv)
(as amended or replaced).

 

 

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Par understands and agrees that any rights granted to Par by the Agreement with
respect to the Par PFS Product, including the limited license described in this
Section 5 and the trigger for the License Effective Date, are contingent on Par
filing an ANDA (or a supplement or amendment to the Par ANDA) for the Par PFS
Product that contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV),
providing, on acceptance for filing or receipt by the FDA, notice and
information to Licensor under 21 U.S.C. § 355(j)(2)(B), a so-called “Paragraph
IV Notice Letter,” relating to all Orange Book listed Licensed Patents, and
agreeing to a consent judgment and permanent injunction with respect to such
ANDA (or product that is the subject of the supplement or amendment to the Par
ANDA.

 

Par acknowledges and agrees that the license granted under Section 5(b)(iv),
above, does not become effective should a sale of a Generic Vial Product or a
Generic PFS Product occur that has not been authorized or licensed by
Plaintiffs, unless Plaintiffs did not, within ten (10) business days after such
unauthorized launch, (a) seek a temporary restraining order (“TRO”) or
preliminary injunction (“PI”) prohibiting any further unauthorized sales of the
Generic Vial Product or Generic PFS Product within the Territory, or (b) enter
into an agreement with the unauthorized party selling the Generic Vial Product
or Generic PFS Product to cease and desist from such sale within sixty (60) days
of the first such unauthorized or unlicensed sale. If, within ten (10) business
days after such unauthorized Third Party launch, Plaintiffs apply for a TRO or
PI prohibiting any further unauthorized sales of the Generic Vial Product or
Generic PFS Product within the Territory, the licenses granted herein shall be
effective on the earlier of (a) the date that such application for a TRO and/or
PI is denied, abandoned, or withdrawn, or (b) ninety (90) days after the date of
such application for a TRO and/or PI was filed, provided that if a TRO or PI
prohibiting any further sale of such Generic Vial Product or Generic PFS Product
is entered during the 90-day period, or if the unauthorized Third Party selling
such Generic Vial Product or Generic PFS Product has otherwise ceased and
desisted from the sale of such Generic Vial Product or Generic PFS Product
during the 90-day period, the licenses shall not become effective until the
occurrence of the next applicable License Effective Date.

 

 

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Plaintiffs hereby also grant Par a waiver of any regulatory exclusivities
concerning Relistor® Injection to which Plaintiffs may be entitled and that may
prevent approval of the Par ANDA on or after the License Effective Date, and
within five (5) business days of Par’s request, Plaintiffs 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.

 

(c)     Subject to Section 5(d) below and provided that Par complies with the
terms of this agreement, Plaintiffs and their Affiliates hereby covenant not to
sue Par and its Affiliates, and any of their predecessors, successors, parents,
subsidiaries, assigns, agents, administrators, attorneys, directors, officers,
employees, representatives, manufacturers, importers, suppliers, distributors,
customers, and insurers, 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 Plaintiffs and/or any of their
Affiliates purporting to cover the Par Vial Product, the Par PFS Product and/or
the making, using, selling, or offering for sale in the Territory, or making or
having made outside the Territory only for importation, use, sale or offering
for sale into or for the Territory of the Par Vial Product or the Par PFS
Product. Plaintiffs hereby agree to impose the foregoing covenant on any
purchaser for value of the subject patents.

 

 

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(d)      In the event that Par: (i) materially breaches Articles 3 or 6 herein,
or (ii) sells the Par Vial Product, the Par PFS Product or any Generic Vial
Product or Generic PFS Product in the Territory prior to the License Effective
Date, then Plaintiffs will have the right to terminate the license granted
herein with immediate effect upon notice to Par. In such event, the covenant not
to sue set forth in Section 5(c) above shall be of no further force and effect.

 

6.       Pre-Commercial/Pre-Marketing License. One hundred fifty (150) days
prior to the License Effective Date (but not earlier), Plaintiffs grant to Par a
limited pre-commercialization license to Manufacture and/or have Manufactured
the Par Vial Product and the Par PFS Product in or for, and/or import or have
imported the Par Vial Product and the Par PFS Product into, the Territory solely
to the extent reasonably necessary to enable Par to Market the Par Vial Product
and the Par PFS Product in the Territory on or after the License Effective Date.
Notwithstanding the foregoing, up to 30 days prior to the License Effective
Date, Par may engage in discussions with potential customers to make them aware
of the upcoming availability of the Par Vial Product and the Par PFS Product,
and offering the Par Vial Product and the Par PFS Product for sale and entering
into non-binding contracts.

 

7.      Non-Interference. From and after the Effective Date, Plaintiffs shall
not (i) file any citizen petition or other submissions with the FDA or any other
governmental agency that interferes with Par’s efforts to: (a) obtain and/or
maintain FDA approval of the Par ANDA; or (b) Market the Par Vial Product and
the Par PFS Product as of the date and under the terms provided in this
Settlement Agreement; or (ii) Officially Discontinue the NDA Product prior to
expiration of the Licensed Patents for reasons other than safety or efficacy.

 

 

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8.       Most Favored Nation. In the event that Plaintiffs, or any of their
Affiliates, enter into any agreement, license, sublicense, settlement, covenant,
waiver, or other authorization or permission of any kind with any Third Party
not the First Applicant for a Generic Vial Product, Generic PFS Product, or
Authorized Generic, granting such Third Party a license or other authorization
under any of the Licensed Patents containing any terms or conditions more
favorable than those provided to Par herein, limited to the License Effective
Date and pre-commercialization and/or pre-marketing rights, Plaintiffs shall
immediately give Par notice of such agreement, subject to written
confidentiality obligations no less restrictive than the confidentiality
obligations set forth in Paragraph 11 of this Settlement Agreement, and this
Agreement shall be automatically amended to include such more favorable terms
accordingly. For avoidance of doubt, the Parties understand and agree that this
Paragraph does not apply to the terms and conditions negotiated with a Section
505(b)(2) Applicant or a First Applicant who has not forfeited, relinquished, or
otherwise waived its Hatch-Waxman exclusivity as described in 21 U.S.C.
§ 355(j)(5)(B)(iv) (as amended or replaced).

 

9.       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.

 

10.     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, except to an Affiliate of the assigning Party 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, but the assigning Party
will remain primarily liable and responsible for the performance of all of its
obligations under this Settlement Agreement and for causing its assignees to act
in a manner consistent herewith. 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.

 

 

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11.      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 that 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 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, Plaintiffs
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.

 

 

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(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
assignees, 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 assignees,
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, or purchasing the relevant
assets of, the receiving Party; (iii) the FDA as may be necessary or useful in
obtaining and maintaining final approval of the Par ANDA and launching the Par
Vial Product and the Par PFS Product when and as permitted by this Settlement
Agreement, so long as Par requests that the FDA maintain such terms in
confidence; and (iv) the extent such disclosure is required or advisable to
comply with Applicable Law, including without limitation SEC reporting
requirements, disclosure requirements to a Party’s bondholders, noteholders, or
debtholders, or the disclosure requirements of any stock exchange that a Party
is subject to, or to defend or prosecute litigation or in connection with
settlement negotiations, provided, however, that the receiving Party provides
prior written notice of such disclosure to the disclosing Party. 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 in writing to confidential treatment of this Settlement Agreement
no less restrictive than the confidentiality obligations set forth in Paragraph
12 of this Agreement.

 

 

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(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 first obtaining the written
approval of the other Parties and agreement upon the nature, text and timing of
such announcement or disclosure; provided, however, that any Party shall have
the right to state that the Lawsuit has been settled pursuant to terms that are
confidential, and shall have the right to make any disclosure 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, subject to the
terms and conditions in Paragraph 6, that Par has obtained a license to launch a
Generic Vial Product and Generic PFS Product in the Territory as of the License
Effective Date. However, Par agrees that any such customer notification will not
be made more than 60 days prior to the License Effective Date. 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.

 

 

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(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 14 days after receiving such request and at least 14 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 who is representing the entity receiving the Confidential
Information. Nothing herein shall preclude any Party from complying with an
order requiring disclosure, or a guidance 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.

 

 

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12.      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.

 

13.      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.

 

 

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(b)     As of the Effective Date: (i) it has the corporate power and authority
and the legal right to 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
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.

 

 

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14.      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 Valeant Pharmaceuticals International, Inc.

400 Somerset Corporate Blvd.,

Bridgewater, NJ, 08807

Phone:  +1 908-927-1400

 

General Counsel

Valeant Pharmaceuticals International, Inc. 

400 Somerset Corporate Blvd.,

Bridgewater, NJ, 08807

Phone: +1 908-927-1400

 

For Salix Pharmaceuticals, Inc.

8510 Colonnade Center Drive

Raleigh, NC 27615

Phone:  +1 919-862-1000

 

For Progenics Pharmaceuticals, Inc.

One World Trade Center
47th Floor Suite J
New York, NY 10007

Phone: +1 646-975-253

Facsimile: +1 646-707-3626

 

External Counsel

Bryan C. Diner

Finnegan

901 New York Avenue, NW

Washington D.C., 20001-4413

Phone: +1 202 408 4116

Facsimile: +1 202 408 4400

 

For Wyeth LLC

235 East 42nd Street

New York, NY 10017

Phone: +1 212-733-2323

 

External Counsel

William P. Deni, Jr.

Gibbons P.C.

One Gateway Center

Newark, NJ 07102

Phone: +1 973 596 4853

Facsimile: +1 973 639 8373

 

 

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For Par Sterile Products, LLC and Par Pharmaceutical, Inc.

 

6 Ram Ridge Road

Chestnut Ridge, NY 10977

Attn: Legal

Phone: 845-573-5500

Facsimile: 845-573-5600

 

External Counsel

David Silverstein

Axinn Veltrop & Harkrider LLP

114 West 47th Street

New York, NY 10036

Phone: 212-261-5651

Facsimile: 212-728-2201

 

 

Any notice shall be effective upon receipt by the Party to which it is addressed
or within seven (7) days of dispatch, whichever is earlier.

 

15.     Indemnities; Product Liability. Par will indemnify and hold harmless
Plaintiffs, their respective Affiliates, and Plaintiffs’ and their respective
Affiliates’ officers, directors, employees and agents from and against any loss,
damage, liability or expense in connection with any and all actions, suits,
claims, demands or prosecutions that may be brought or instituted against any of
Plaintiffs, their respective Affiliates, or such other indemnitees by Third
Parties (including, without limitation, governmental authorities) based on or
relating to any breach by Par of this Settlement Agreement. Plaintiffs will
indemnify and hold harmless Par, its respective Affiliates, and Par’s and its
respective Affiliates’ officers, directors, employees and agents from and
against any loss, damage, liability or expense in connection with any and all
actions, suits, claims, demands or prosecutions that may be brought or
instituted against any of Par, its respective Affiliates, or such other
indemnitees by Third Parties (including, without limitation, governmental
authorities) based on or relating to any breach by Plaintiffs of this Settlement
Agreement.

 

 

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16.     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.

 

17.     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.

 

18.     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.

 

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

 

 

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20.     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.

 

21.     Costs and Fees. Each Party shall bear its own attorneys’ fees and costs
associated with the Lawsuit and the negotiation and preparation of this
Settlement Agreement.

 

22.    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.

 

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

 

24.     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.

 

 

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25.     Bankruptcy. All licenses and rights to licenses granted under or
pursuant to this Settlement Agreement by Plaintiffs 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 Plaintiffs 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 (i) upon any such
commencement of a bankruptcy proceeding upon written request therefor by Par,
unless Plaintiffs elect to continue to perform all of its obligations under this
Settlement Agreement by or on behalf of Plaintiffs upon written request therefor
by Par or (ii) if not delivered under (i) above, upon the rejection of this
Settlement Agreement by or on behalf of Plaintiffs 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.

 

 

VALEANT PHARMACEUTICALS

INTERNATIONAL, INC.

 

 

 

By:          /s/ Christina Ackermann__________

Name: Christina Ackermann

Title: EVP, General Counsel

 

Date:       April 26, 2018________________

     

SALIX PHARMACEUTICALS, INC.

 

 

 

By:          /s/ Mark McKenna________________

Name: Mark McKenna

Title: SVP, Salix

 

Date:       May 2, 2018_____________________

     

PROGENICS PHARMACEUTICALS, INC.

 

 

 

By:          /s/ Patrick Fabbio______________

Name: Patrick Fabbio

Title: CFO

 

Date:       May 10, 2018_________________

 

WYETH LLC

 

 

 

By:         /s/ Jeffery N. Myers____________

Name: Jeffrey N. Myers

Title: Attorney in Fact

 

Date:       May 10, 2018_____________________

 

 

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PAR STERILE PRODUCTS, LLC

 

 

 

By:       /s/ Lawrence M. Brown_________

            Name: Lawrence M. Brown

            Title: Vice President, Legal

 

Date:    April 24, 2018_______________

 

 

PAR PHARMACEUTICAL, INC.

 

 

 

By:       /s/ Lawrence M. Brown_________

            Name: Lawrence M. Brown

            Title: Vice President, Legal

 

Date:    April 24, 2018_______________

 

 

 

 

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Exhibit A

 

 

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

 

 

VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; SALIX PHARMACEUTICALS, INC.;
PROGENICS PHARMACEUTICALS, INC.; and WYETH LLC, formerly known as WYETH,

 

Plaintiffs,

 

v.

 

PAR STERILE PRODUCTS, LLC and PAR PHARMACEUTICALS, INC. 

 

Defendants.

 

 

 

 

 

 

 

 

Civil Action No. ______

 

 

 

STIPULATEd consent judgment AND injunction

 

Whereas Plaintiffs Valeant Pharmaceuticals International (“Valeant”), Salix
Pharmaceuticals, Inc. (“Salix”), Progenics Pharmaceuticals, Inc. (“Progenics”)
and Wyeth LLC (“Wyeth”) and Defendants Par Sterile Products, LLC (“Par Sterile”)
and Par Pharmaceuticals, Inc. (“Par Pharmaceuticals”) (Par Sterile and Par
Pharmaceuticals, collectively, “Par”) have agreed to the terms and conditions
representing a negotiated settlement of this action and have set forth those
terms and conditions in a Confidential Settlement and License Agreement (the
“Settlement Agreement”),

 

 

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IT IS HEREBY STIPULATED AND AGREED, by and between Plaintiffs and Par, through
their undersigned counsel of record, that:

 

1.     In the event that the claims of Plaintiffs’ U.S. Patent No. 8,552,025
(“the ’025 Patent”), U.S. Patent No. 9,669,096 (“the ’096 Patent”), U.S. Patent
No. 8,247,425 (“the ’425 Patent”), U.S. Patent No. 8,420,663 (“the ’663
Patent”), U.S. Patent No. 8,822,490 (“the ’490 Patent”), U.S. Patent No.
9,190,125 (“the ’125 Patent”), U.S. Patent No. 9,492,445 (“the ’445 Patent”)
asserted against Par are not held invalid or unenforceable, absent a license or
other authorization from Plaintiffs, the ’025 Patent, the ’096 Patent, the ’425
Patent, the ’663 Patent, the ’490 Patent, the ’125 Patent, and the ’445 Patent
would be infringed by any unlicensed manufacture, sale, offer for sale, use, or
importation in the United States of the generic product that is the subject of
Par’s Abbreviated New Drug Application (the “Par Vial Product”, as defined in
the Parties’ Settlement Agreement).

 

2.     Par and anyone acting on the behalf of Par, except as expressly licensed
by Plaintiffs, will be enjoined until expiration of the ’025 Patent, the ’096
Patent, the ’425 Patent, the ’663 Patent, the ’490 Patent, the ’125 Patent, and
the ’445 Patent from (i) making, using, offering to sell, selling, or importing
until expiration of the ’025 Patent, the ’096 Patent, the ’425 Patent, the ’663
Patent, the ’490 Patent, the ’125 Patent, and the ’445 Patent the Par Vial
Product in the United States, and (ii) participating in the profits from making,
using, offering to sell, selling, or importing the Par Vial Product in the
United States, and (iii) indemnifying others with respect to any making, using,
offering to sell, selling, or importing the Par Vial Product in the United
States.

 

3.     Notwithstanding any provision of the foregoing, Par shall be entitled to
contest the infringement, validity and/or enforceability of the ’025 Patent, the
’096 Patent, the ’425 Patent, the ’663 Patent, the ’490 Patent, the ’125 Patent,
and the ’445 Patent in any future litigation over the ’025 Patent, the ’096
Patent, the ’425 Patent, the ’663 Patent, the ’490 Patent, the ’125 Patent
and/or the ’445 Patent pertaining to any product that is not the Par Vial
Product and is not the subject of the Par ANDA (as defined in the Parties’
Settlement Agreement).

 

 

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4.     Each party will bear its own attorneys’ fees and costs.

 

5.     This Court will retain jurisdiction to enforce this Stipulated Consent
Judgment and Injunction and the parties’ related agreements resolving this
matter.

 

6.     Plaintiffs acknowledge that Par is entitled to maintain its Paragraph IV
certification to the ’025 Patent, the ’096 Patent, the ’425 Patent, the ’663
Patent, the ’490 Patent, the ’125 Patent, and the ’445 Patent pursuant to 21
C.F.R. § 314.94(a)(12)(v). Each Party acknowledges and agrees that the 30-month
stay with respect to the approval of the Par ANDA under 21 U.S.C. §
355(j)(5)(B)(iii) is hereby terminated.

 

7.     The Clerk of Court is directed to enter this Stipulated Consent Judgment
and Injunction.

 

Dated: April __, 2018

Gibbons P.C.

 

Attorneys for Plaintiffs Valeant Pharmaceuticals International, Inc., Salix
Pharmaceuticals, Inc., Progenics Pharmaceuticals, Inc., and Wyeth LLC

 

 

___________________________

William P. Deni, Jr.

Charles H. Chevalier

J. Brugh Lower

One Gateway Center

Newark, NJ 07102

(973) 596-4500

 

 

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Of Counsel:

Bryan C. Diner

Justin J. Hasford

Megan Leinen Johns

Kristi L. McIntyre

FINNEGAN, HENDERSON,

FARABOW, GARRETT & DUNNER, LLP

901 New York Avenue, NW

Washington, DC 20001-4413

(202) 408-4000

 

Jessica M. Lebeis

FINNEGAN, HENDERSON,

FARABOW, GARRETT & DUNNER, LLP

271 17th Street, NW

Suite 1400

Atlanta, GA 30363-6209

(404) 653-6400

 

________________________________

Sean R. Kelly

SAIBER LLC

18 Columbia Turnpike, Suite 200

Florham Park, NJ 07932

Tel: 973-645-4801

Fax: 973-622-3349

skelly@saiber.com

 

Of Counsel:

 

David H. Silverstein

AXINN, VELTROP & HARKRIDER LLP

114 West 47th Street

New York, New York 10036

Tel.: (212) 261-5651

dsilverstein@axinn.com

 

Aziz Burgy

AXINN, VELTROP & HARKRIDER LLP

950 F Street, NW

Washington, D.C. 20004

Tel.: (202) 721-5417

aburgy@axinn.com

Dated: April 13, 2018

 

Attorneys for Defendants Par Sterile Products, LLC and Par Pharmaceuticals, Inc.

 

 

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So Ordered: ________________________

 

 

Confidential Settlement Agreement Page 32 of 32