Exhibit 10.1

[***] Text omitted and filed separately with the Securities and Exchange

Commission/Confidential Treatment Requested under 17 C.F.R. Section 240.24b-2

THIS DEVELOPMENT, LICENSE AND COMMERCIALIZATION AGREEMENT (this “Agreement”) is
entered into and effective as of December 18, 2018 (the “Effective Date”) by and
between Endo Ventures Limited, an Irish company, with offices located at First
Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland (“EVL”),
and Catalyst Pharmaceuticals, Inc., a Delaware corporation, with offices located
at 355 Alhambra Circle Suite 1250, Coral Gables, FL, USA (“Catalyst”).

W I T N E S S E T H

WHEREAS, Catalyst has undertaken certain development activities relating to the
preparation of a generic pharmaceutical formulation of the Product [***]; and

WHEREAS, Catalyst desires to (a) continue development activities with respect to
the Product together with EVL and (b) [***] to enable EVL to manufacture or have
manufactured, and market and distribute, a generic version of the Brand Product
(as defined below) in the Territory, subject to the terms and provisions hereof.

NOW, THEREFORE, in consideration of the mutual covenants and agreements of the
Parties contained herein and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:

ARTICLE 1. DEFINITIONS

Capitalized terms used in this Agreement shall have the following definitions:

“Acquisition Cost” means the cost of manufacturing or acquiring the Product by
EVL and/or its Affiliates, calculated in accordance with GAAP, as applicable,
but without any duplication of any such costs, as follows:

(a)    if the Product is manufactured by EVL (or its Affiliates) (x) [***], plus
(y) [***], or

(b)    if the Product is manufactured by a Third Party Manufacturer, (x) [***],
plus (y) [***].

“Affiliate(s)” means, with respect to a Party, any Person that is directly or
indirectly controlled by, controlling, or is under common control with such
Party. For purposes of this definition only, the term “control” (including, with
correlative meaning, the terms “controlling”, “controlled by”, and “under common
control with”), as used with respect to the applicable Party, means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of the applicable Person, whether
through ownership of interests

 

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representing equity, securities, or partnership interests or by contract, or
otherwise. Ownership of more than fifty percent (50%) of such equity, securities
or partnership interests in a Person, or greater than fifth percent (50%)
interests in the income of such Person shall, without limitation, be deemed to
be control for purposes of this definition.

“Agreement” has the meaning given to such term in the introductory paragraph of
this Agreement.

“ANDA” means an Abbreviated New Drug Application pursuant to 21 U.S.C. § 355(j)
et seq., and the regulations promulgated thereunder, as such application may be
amended or supplemented from time to time.

“ANDA Transfer” has the meaning set forth in Section 4.1.2.

“Anti-Corruption Laws” has the meaning set forth in Section 9.3.1.

“API” means, with respect to the Product, the active pharmaceutical
ingredient(s) in such Product.

“Applicable Laws” means all laws, rules, regulations and guidelines of any
Governmental Authority with jurisdiction over the development, manufacturing,
exportation, importation, promotion, marketing, sale or distribution of the API
or the Product and/or the performance of a Party’s obligations under this
Agreement, to the extent applicable and relevant, and including specifically all
cGMP or similar standards or guidelines of the FDA and other applicable
Regulatory Authorities and compendial guidelines (e.g., United States
Pharmacopeia or European Pharmacopeia), as well as Export Control Laws, and the
FCPA and other Anti-Corruption Laws, in each case to the extent applicable to
the performance of a Party’s obligations under this Agreement.

“Bioequivalence Studies” means any bioequivalence study conducted by or on
behalf of Catalyst or its Affiliates which is undertaken to satisfy the FDA’s
requirements for bioequivalence in connection with establishing that a Drug
Product subject to an ANDA is a Therapeutic Equivalent of the Brand Product
referenced in such ANDA.

“Brand Product” means the reference listed drug product, Sabril®, that is the
subject of NDA No. 020427, as may be amended or supplemented from time to time.

“Business Day” means any day (other than a Saturday or Sunday) on which banking
institutions in New York, New York, United States, and in Dublin, Ireland are
open for business.

“Calendar Quarter” means a three (3) consecutive month period ending on
March 31, June 30, September 30 or December 31.

“Catalyst” has the meaning given to such term in the introductory paragraph of
this Agreement.

“Catalyst Indemnitee” has the meaning set forth in Section 10.2.

 

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“Catalyst Intellectual Property” means Intellectual Property that (i) is
Controlled by Catalyst and/or its Affiliates and (ii) covers the Product.

“cGMP” means all current good manufacturing practices as may be applicable,
including: (a) as required by the provisions of 21 C.F.R., parts 210 and 211 and
all applicable rules, regulations, orders and guidances of the FDA and other
applicable Regulatory Authorities; and (b) ICH, Guidance for Industry Q7a Good
Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

“Code” has the meaning set forth in Section 12.6.2.

“Commercial Launch” means the first commercial sale in the Territory of the
Product by EVL, its Affiliate or sublicensee, as the case may be, to a Third
Party.

“Commercialize” or “Commercialization” means the marketing, promotion, sale (and
offer for sale or contract to sell), distribution, importation or other
commercial exploitation of the Product. Commercialization shall include
commercial activities conducted in preparation for Commercial Launch.

“Commercially Reasonable Efforts” means (a) with respect to product development
efforts, the carrying out of such obligations or tasks with the level of effort
and resources consistent with commercially reasonable practices normally devoted
by a pharmaceutical company to their research, development or manufacturer of a
similar pharmaceutical product owned by it (or to which it has exclusive rights)
at a similar stage of development, a similar market potential, a similar profit
potential and strategic value, and (b) with respect to Commercialization, the
carrying out of such obligations or tasks with a level of effort and resources
consistent with commercially reasonable practices normally devoted by a
pharmaceutical company based on conditions then prevailing including issues of
safety and efficacy, product profile, competiveness of alternative products in
the market place, pricing and reimbursement for the Product, the likely timing
of the Product’s entry into the market and other relevant technical and
commercial factors.

“Competitive Product” has the meaning set forth in Section 2.2.1.

“Compliance Event” has the meaning set forth in Section 9.3.4.

“Confidential Information” means, with respect to a Disclosing Party, all
non-public information of any kind whatsoever (including data, materials,
compilations, formulae, models, patent disclosures, procedures, processes,
projections, protocols, results of experimentation and testing, specifications,
strategies, techniques and all non-public Intellectual Property as defined
herein), and all tangible and intangible embodiments thereof of any kind
whatsoever (including materials, samples, compositions, documents, drawings,
patent applications, records and reports) of the Disclosing Party and/or its
Affiliates, which are disclosed by the Disclosing Party and/or its Affiliate to
the Receiving Party and/or its Affiliate, including any and all copies,
replication or embodiments thereof. Confidential Information of both Parties
includes the terms, conditions and provisions of this Agreement and Protected
Personal Information.

Notwithstanding the foregoing, and except for Protected Personal Information,
Confidential Information of a Disclosing Party shall not include information
that the Receiving

 

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Party can establish by competent proof to have (a) been publicly known prior to
disclosure of such information by the Disclosing Party and/or its Affiliate to
the Receiving Party and/or its Affiliate, (b) become publicly known, without
fault on the part of the Receiving Party and/or its Affiliate, subsequent to
disclosure of such information by the Disclosing Party and/or its Affiliate to
the Receiving Party and/or its Affiliate, (c) been received by the Receiving
Party and/or its Affiliate from a source rightfully having possession of, and
the right to disclose, such information free of an obligation of
confidentiality, (d) been otherwise rightfully known by the Receiving Party
and/or its Affiliate prior to disclosure of such information by the Disclosing
Party and/or its Affiliate to the Receiving Party and/or its Affiliate, or
(e) been independently developed by employees or agents of the Receiving Party
and/or its Affiliate without the use of Confidential Information of the
Disclosing Party and/or its Affiliate.

“Controlled” means the legal or regulatory right (whether by ownership, license
or otherwise) to grant access, right, title, a license or a sublicense to
Intellectual Property without violating the terms of any Third Party agreement,
court order, or other arrangement or legal obligation.

“Cost of Goods Sold” means [***].

“Data Protection Laws” has the meaning set forth in Section 9.3.2.

“Disclosing Party” means the Party disclosing Confidential Information hereunder
to the other Party.

[***]

[***]

“DMF” means a drug master file for the API to be used in the Product, which has
been filed by [***] with the FDA pursuant to 21 C.F.R. § 314.420 (or, if
applicable, any other Applicable Laws outside of the United States).

“Drug Product” means a drug product, as defined in 21 C.F.R. § 314.3, for
administration to human subjects.

“Effective Date” has the meaning given to such term in the introductory
paragraph of this Agreement.

“EVL” has the meaning given to such term in the introductory paragraph of this
Agreement.

“EVL Facility” means the facility of EVL or its Affiliate designated in writing
by EVL to Catalyst.

“EVL Indemnitee” has the meaning set forth in Section 10.1.

“Export Control Laws” means all applicable U.S. laws and regulations relating to
(a) economic and trade sanctions and embargoes imposed by the Office of Foreign
Assets Control of

 

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the U.S. Department of Treasury or (b) the export or re-export of commodities,
technologies, or services, including the Export Administration Act of 1979, 24
U.S.C. §§ 2401-2420, the International Emergency Economic Powers Act, 50 U.S.C.
§§ 1701-1706, the International Traffic in Arms Regulations, 22 C.F.R. parts
120-130, the Trading with the Enemy Act, 50 U.S.C. §§ 1 et. seq., the Arms
Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the International Boycott
Provisions of Section 999 of the U.S. Internal Revenue Code of 1986 (as
amended).

“FCPA” means U.S. Foreign Corrupt Practices Act (15 U.S.C. Section 78dd-1, et.
seq.) as amended.

“FDA” means the United States Food and Drug Administration, and any successor
agency thereto.

“FD&C Act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et
seq, as amended.

“Force Majeure Event” has the meaning set forth in Section 14.12.

“Freight Charges” means [***].

“Further Development Work” means the development activities necessary or
desirable to support obtaining Regulatory Approval for [***] which are either
described in Exhibit A attached hereto to the extent of the respective amount
budgeted for such activities on such Exhibit and any additional activities and
costs to the extent approved by each of the Parties during a meeting of the JSC
in writing in the exercise of their respective sole discretion, acting
reasonably.

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

“Generic Equivalent” means a pharmaceutical product that has received FDA
approval for marketing in the Territory pursuant to an ANDA as a generic version
of the Brand Product.

“Government Official” means any (a) officer, employee of a government or any
department, agency or instrument of a government; (b) person acting in an
official capacity for or on behalf of a government or any department, agency, or
instrument of a government; (c) officer or employee of a company or business
owned in whole or part by a government; (d) officer or employee of a public
international organization such as the World Bank or United Nations; (e) officer
or employee of a political party or any person acting in an official capacity on
behalf of a political party; and/or (f) candidate or relative of any candidate
for political office.

“Governmental Authority” means any court, tribunal, arbitrator, agency,
legislative body, commission, official, authority, department, regulatory body
or other instrumentality of (i) any government in the Territory, or (ii) any
national, federal, state, province, region, county, city or other political
subdivision of any such government or any supranational organization of which
any such country is a member, which has competent and binding authority to
decide, mandate, regulate, enforce, or otherwise control the activities of the
Parties or their Affiliates contemplated by this Agreement.

 

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“Gross Amount” means the gross amount invoiced for the Product sold by EVL, its
Affiliates or a sublicensee, as the case may be, in the Territory.

“Healthcare Professional” means any member of the medical, pharmacy or nursing
professions or any other person who in the course of his or her professional
activities may prescribe, purchase, supply or administer a medicinal product.

“Indemnitee” has the meaning set forth in Section 10.3.

“Indemnitor” has the meaning set forth in Section 10.3.

“Insolvency Event” means, with respect to a Party:

(a)    a voluntary case or proceeding under any applicable bankruptcy,
insolvency, or other similar law is commenced by such Person, or such Person
consents to the entry of an order for relief in an involuntary case or
proceeding under any such law or against such Person, or such Person consents to
the appointment of or taking possession by a receiver, liquidator, assignee,
trustee, custodian, sequestrator, conservator, supervisor, rehabilitator (or
other similar official) of such Person or for any material portion of such
Person’s assets and properties, or such Person makes a general assignment for
the benefit of creditors, or such Person fails generally to pay, or admits in
writing its inability to pay, its debts as they become due or takes any company
action in furtherance of the foregoing;

(b)    the commencement of an involuntary case or proceeding under any
applicable bankruptcy, insolvency, or other similar law against such Person, and
such case or proceeding is not dismissed within ninety (90) days;

(c)    the entry by a Governmental Authority having jurisdiction over such
Person of a decree or order appointing a receiver, liquidator, assignee,
custodian, trustee, sequestrator, conservator, supervisor, rehabilitator (or
similar official) for such Person or for any material portion of such Person’s
assets and properties, or ordering the winding-up, supervision, or liquidation
of such Person’s affairs; or

(d)    the taking of any formal action by such Person, its board of directors
(or similar governing body) or holders of its voting securities authorizing any
of the foregoing.

“Intellectual Property” means all of the following: (i) patent applications,
continuation applications, continuation-in-part applications, divisional
applications, and United States patents corresponding to any of the foregoing
that may grant or may have been granted on any of the foregoing, including
reissues, re-examinations and extensions and any supplemental protection
certificates, or the like; (ii) all Know-How, work product, trade secrets,
inventions (whether patentable or otherwise), data, processes, techniques,
procedures, compositions, devices, methods, formulas, protocols and information,
whether patentable or not; (iii) copyrightable works, copyrights and
applications, registrations and renewals; (iv) logos, trademarks, service marks,
and all applications and registrations relating thereto; (v) other proprietary
rights; (vi) any regulatory exclusivities or the like; and (vii) copies and
tangible embodiments of any one or more of the foregoing, including the
Bioequivalence Studies. For purposes of clarity, data, information and methods
related to the Product and its components developed in connection with this
Agreement shall be considered Intellectual Property, whether or not patentable,
confidential, or otherwise subject to intellectual property protection laws.

 

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“Interfering Event” means any of the following events: (i) pending litigation
concerning [***] or the Product or (ii) any litigation, threatened in writing by
a Third Party that the development or manufacture of the Product by any of the
Parties or a Third-Party manufacturer infringes any intellectual property rights
of any Third Party; (iii) government restrictions due to safety issues or
concerns, including a disruption or halt in operations of the Vigabatrin REMS
Program; (iv) inability to manufacture sufficient launch quantities of the
Product due to unavailability of API, materials or components; (v) the receipt
of non-saleable product from a contract manufacturing organization; or (vi) an
API supplier warning letter.

“JSC” has the meaning set forth in Section 3.2.1.

“Know-How” means all of the following: manufacturing protocols and methods,
product specifications, analytical methods and assays, processes, formulations,
product designs, plans, trade secrets, ideas, concepts, manufacturing
information, engineering and other manuals and drawings, standard operating
procedures, flow diagrams, chemical data, pharmacological data, pharmacokinetic
data, toxicological data, pharmaceutical data, physical and analytical data,
safety data, quality assurance data, quality control and clinical data,
technical information, other data, and research records.

“Label,” “Labeled” or “Labeling” refers to such labels and other written,
printed or graphic matter, (i) upon any container or wrapper utilized with the
Product, or (ii) accompanying the Product, including Package inserts.

“Liabilities” has the meaning set forth in Section 10.1.

“Milestone Payment” has the meaning set forth in Section 6.2.

“Negative Amount” has the meaning set forth in Section 6.1.2(c).

“Net Profit Report” has the meaning set forth in Section 6.1.2(b).

“Net Profits” means Net Sales, less (i) the Acquisition Cost, (ii) the Sales &
Distribution Expenses, and (iii) the REMS Payments. For the avoidance of doubt,
there shall be no deductions for the costs of Further Development Work in
determining Net Sales and Net Profits.

“Net Sales” means the Gross Amount, less the following deductions (provided no
such deduction shall be duplicative of another deduction used to determine Net
Sales or Net Profits), to the extent accrued, paid or allowed in accordance with
GAAP:

(a)    [***];

(b)    [***];

(c)    [***];

 

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(d)    [***];

(e)    [***];

(f)    [***];

(g)    [***]; and

(h)    [***].

“OFAC” has the meaning set forth in Section 9.3.3.

“Orange Book” means the FDA publication Approved Drug Products with Therapeutic
Equivalence Evaluations, as may be amended from time to time.

“Package,” “Packaged” or “Packaging” means all primary containers, including
bottles, cartons, shipping cases or any other like matter used in packaging or
accompanying a Product.

“Party” means EVL or Catalyst, as applicable, and “Parties” means both EVL and
Catalyst.

“Person” means an individual, corporation, partnership, limited liability
company, firm, association, joint venture, estate, trust, governmental or
administrative body or agency, or any other entity.

“Proceedings” means governmental, judicial, administrative or adversarial
proceedings (public or private), litigation, suits, patent oppositions,
arbitration, disputes, claims, causes of action or investigations.

“Product” means the Drug Product [***] that references the Brand Product,
including all dosage strengths, and all packaging configurations thereof.

“Product Claim” has the meaning set forth in Section 10.5.

[***].

“Protected Personal Information” has the meaning set forth in Section 9.3.2.

“Receiving Party” means the Party receiving Confidential Information hereunder
from the other Party.

“Regulatory Approval” means the applicable approval(s) from Regulatory
Authorities necessary to market a Drug Product and/or an active pharmaceutical
ingredient, including all applicable product and/or establishment licenses,
registrations, permits or other authorizations as may be necessary for the
commercial manufacture, commercialization, use, storage, importation, transport,
promotion, pricing, distribution or sale thereof.

 

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“Regulatory Authority(ies)” means the Governmental Authority(ies) in the
Territory with authority over the manufacture, market approval, sale,
distribution, packaging or use of a Drug Product in the Territory (including the
grant of Regulatory Approval by the FDA).

“Regulatory Documentation” means the following to the extent related to the
Product, owned and maintained by or on behalf of Catalyst and/or its Affiliates
or otherwise in the possession of Catalyst or its Affiliates: the [***] and
batch records relevant to the Product.

“REMS” has the meaning set forth in Section 4.4.

“REMS Payments” means [***].

“Representatives” has the meaning set forth in Section 8.1.

“Royalty” has the meaning set forth in Section 6.1.1.

“Sales & Distribution Expenses” means [***].

“Specifications” means the specifications for the manufacture of the Product as
described in [***].

“Stable” means a Drug Product that meets FDA requirements for stability for
purposes of Regulatory Approval.

“Tax” or “Taxes” shall mean all taxes, including income, corporation, gross
receipts, transfer, excise, property, sales, harmonized sales, use, value-added,
license, payroll, withholding, social insurance, employment insurance, employer
health, franchise or other governmental taxes, imposed by any Taxing Authority
(including any interest, penalties or additional tax attributable thereto).

“Taxing Authority” shall mean any Governmental Authority, exercising any
authority to impose, regulate or administer the imposition of Taxes.

“Term” has the meaning set forth in Section 12.1.

“Territory” means the United States of America, and its commonwealths,
territories, districts and possessions, including the District of Columbia,
Commonwealth of Puerto Rico, US Virgin Islands, Guam, American Samoa; and any
installation, territory, location or jurisdiction under the purview of the FDA
or control of the United States government; and any United States military bases
and installations worldwide.

“Therapeutic Equivalent” has the meaning given to it by the FDA in the current
edition of the Orange Book.

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

 

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“Third Party Manufacturer” has the meaning set forth in Section 5.1.

“Third Party Supply Agreement” has the meaning set forth in Section 5.1.

ARTICLE 2. LICENSE AND EXCLUSIVITY

2.1    License Grant.

2.1.1    Catalyst hereby grants to EVL an exclusive (even as to Catalyst),
irrevocable (subject to Section 12.6), license (with the right to sublicense as
set forth in Section 2.1.2 ) under the Catalyst Intellectual Property to
manufacture, have manufactured, distribute, have distributed, use, market, have
marketed, sell, have sold, import, and export for the purpose of
Commercialization of the Product in the Territory, pursuant to the terms of this
Agreement.

2.1.2    The license granted under Section 2.1.1 is sublicensable by EVL, in
whole or in part. Any such sublicense shall be consistent with the terms of this
Agreement, unless any variations thereof are agreed in writing between the
Parties, and shall not otherwise diminish EVL’s obligations hereunder. EVL shall
cause its sublicensees to comply with the terms of this Agreement.

2.2    Exclusivity; Non-Competition.

2.2.1    Except as expressly set forth in this Agreement, during the Term,
Catalyst, by itself, its Affiliate or through any Third Party, shall not,
directly or indirectly, develop, seek Regulatory Approval for, manufacture,
import, market, sell, distribute, or otherwise Commercialize any Drug Product
that is a Therapeutic Equivalent of the Product (“Competitive Product”) or
otherwise work on the development of, or supply of any Competitive Product
(i) in the Territory, or (ii) to any Third Party outside the Territory which
Catalyst knows, or should know, that such Third Party intends to import such
Competitive Product in the Territory.

2.2.2    Except as expressly set forth in this Agreement, during the Term, EVL,
by itself, its Affiliate or through any Third Party, shall not, directly or
indirectly, develop, seek Regulatory Approval for, manufacture, import, market,
sell, distribute, or otherwise Commercialize any Competitive Product or
otherwise work on the development of, or supply of any Competitive Product
(i) in the Territory, or (ii) to any Third Party outside the Territory which EVL
knows, or should know, that such Third Party intends to import such Competitive
Product in the Territory.

ARTICLE 3. DEVELOPMENT AND COMMERCIALIZATION

3.1    Development.

3.1.1    Catalyst shall exercise Commercially Reasonable Efforts to develop, or
cause the development of, a final finished, Stable dosage form of the Product
conforming to the Specifications, except that Catalyst will be excused from the
duty to exercise such efforts to the extent that the Third Party out-of-pocket
costs which would be required to be expended for such purpose are not included
in the Further Development Work. Notwithstanding the foregoing, the Parties
shall collaborate on any development activities necessary or desirable after the
date hereof to support obtaining Regulatory Approval for [***] in the Territory.

 

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3.1.2    In connection with the activities of Catalyst under Section 3.1.1, EVL
shall provide reasonable assistance with respect to Further Development Work and
the commercial manufacturing process validation for the Product. The Parties
shall share equally in the costs and expenses incurred by EVL and Catalyst after
the date hereof in connection with such Further Development Work. Either Party
may on a monthly basis until the expiration of the Calendar Quarter following
the date of obtaining Regulatory Approval issue reasonably detailed invoices to
the other Party setting forth the costs incurred by such Party as a part of the
Further Development Work, half of which amounts shall be reimbursed by the other
Party within sixty (60) days following the receipt of such invoice.

3.1.3    In connection with such Further Development Work, each Party shall
promptly transfer to the other Party all data, information and materials
generated or obtained in connection with the Product, including with respect to
the components thereof, and all associated methods and analytical testing.

3.2    Joint Steering Committee.

3.2.1    Promptly following the date hereof, but in no event later than thirty
(30) days thereafter, EVL and Catalyst will form a joint steering committee (the
“JSC”) to provide executive oversight and to facilitate information sharing
between the Parties with respect to any Further Development Work.

3.2.2    The JSC will be composed of an equal number of representatives
appointed by each of EVL and Catalyst. Each individual appointed will be an
employee or contractor of such Party or such Party’s Affiliate. Each Party may
replace any of its JSC representatives at any time upon written notice to the
other Party, which notice may be given by e-mail, sent to the other Party. Each
JSC representative will be subject to confidentiality obligations no less
stringent than those in Article 8.

3.2.3    The JSC will hold meetings within five (5) Business Days after
receiving communications from the FDA regarding the Product to determine what,
if any, Further Development Work is required and the approved costs in
connection therewith. The JSC may meet in person or by audio or video conference
as its representatives may mutually agree. No action taken at a meeting will be
effective unless at least one representative of each Party is present or
participating. Neither Party will unreasonably withhold attendance of at least
one representative of such Party at any meeting of the JSC for which reasonable
advance notice was provided. Each Party shall bear the costs and expenses
incurred by its own JSC representatives in participating in the JSC meetings.

3.2.4    The Parties will endeavor in good faith to reach unanimous agreement
with respect to all matters within the JSC’s authority. Should the JSC not be
able to reach unanimous agreement with respect to such matter at a duly called
meeting of the JSC, either Party may refer such matter for resolution to a
Vice-President or other executive officer of each Party having decision making
authority on such matter and designated in writing by such Party to the other

 

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Party within thirty (30) days following the Effective Date, and such executive
officers will attempt to resolve the matter in good faith. If the executive
officers fail to resolve such matter within twenty (20) Business Days after the
date on which the matter is referred to the executive officers (unless a longer
period is agreed to by the Parties), then decisions regarding such matter may be
finally determined in accordance with the procedures set forth in Section 14.10.

3.3    Commercial Scale-Up. At EVL’s request, Catalyst shall, at its own cost
and expense, provide reasonable assistance with respect to EVL’s preparation for
Commercial Launch of the Product by making knowledgeable Catalyst personnel
available for consultation with EVL, it being understood that for the purposes
hereof ‘reasonable assistance’ shall mean the provision of assistance consistent
with Catalyst’s business, to the best of Catalyst’s abilities with its
then-currently existing and available resources.

3.4    Product Commercialization.

3.4.1    EVL shall exercise its Commercially Reasonably Efforts to Commercialize
the Product. Subject to complying with its obligations under the preceding
sentence, EVL shall have the sole and exclusive right to make determinations
regarding the Commercialization of the Product in the Territory, including the
timing of the Commercial Launch and responsibility for all sales/marketing and
promotional activities.

3.4.2    Upon the Commercial Launch, EVL (or its Affiliate) will market and sell
the Product, from the EVL Facility or such other facility as EVL may elect in
its sole discretion, under EVL’s (or its Affiliate’s) label in a manner
consistent with EVL’s normal practices with respect to its other Drug Products.

3.5    Updates. Catalyst shall keep EVL informed and provide regular updates of
the progress on the Regulatory Approval of the [***], communications with
Regulatory Authorities related to the Product or Regulatory Approval thereof,
and EVL shall keep Catalyst informed and provide regular updates of the progress
on the Commercial Launch.

ARTICLE 4. REGULATORY MATTERS

4.1    Regulatory Approvals and Applications.

4.1.1    [***].

4.1.2    [***].

4.1.3    [***]

4.1.4    [***].

4.1.5    [***].

4.1.6    [***].

 

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4.2    Product Inserts and Labeling. EVL shall be solely responsible for the
text and regulatory compliance of all package Labels, Product inserts and other
Labeling used in connection with obtaining Regulatory Approval in the Territory
for the [***].

4.3    Product Regulatory Reporting; Compliance With Applicable Laws. From and
after the ANDA Transfer, EVL shall be solely responsible for adverse event
reporting to the FDA, investigation and analysis of end-user complaints and
otherwise complying with Applicable Laws with respect to the Commercialization
of the Product and ownership of the Regulatory Approval. EVL shall have
responsibility for communicating with the end-users to support the complaint
handling process.

4.4    REMS. FDA has determined that a Risk Evaluation and Mitigation Strategy
(“REMS”) is necessary to assure safe use of the Product. The Product is
currently subject to the FDA-approved single shared system Vigabatrin REMS
Program. EVL will have sole discretion over the evaluation and management of the
Vigabatrin REMS Program. The REMS Payments will not include any historical setup
fee for the REMS Program. The Parties shall each bear half of the incremental
setup cost that either Party bears that are specific to the Product as a part of
the Further Development Work.

ARTICLE 5. MANUFACTURE

5.1    Third Party Manufacture of Product. During the Term and subject to
Section 5.2, EVL shall engage [***] (or its Affiliate) or a Third Party
manufacturer of the Product mutually agreed upon by the Parties (a “Third Party
Manufacturer”) pursuant to a manufacture and supply agreement with such Third
Party Manufacturer (the “Third Party Supply Agreement”), which EVL will exercise
Commercially Reasonable Efforts to enter into as soon as reasonably practicable
after the Effective Date. EVL shall also collaborate in good faith with Catalyst
in connection with the preparation and completion of the Third Party Supply
Agreement which collaboration shall include affording Catalyst the opportunity
to review and comment upon drafts of the Third Party Supply Agreement and
accommodating to the extent practicable the reasonable comments of Catalyst on
such agreement. At any time during the Term, EVL shall be entitled to engage a
different manufacturer of the Product mutually agreed upon by the Parties.

5.2    Manufacture by EVL. At any time during the Term, and subject to the terms
of the Third Party Supply Agreement, EVL shall be entitled to become the
exclusive manufacturer of the Product in the Territory by providing written
notice thereof to Catalyst. Following the ANDA Transfer, EVL shall use
commercially reasonable efforts to transfer the manufacturing of the Product in
the Territory to EVL or one of its Affiliates.

ARTICLE 6. FINANCIAL PROVISIONS

6.1    Royalties.

6.1.1    Royalty Rates. EVL shall pay to Catalyst a royalty (the “Royalty”)
equal to [***] percent ([***]%) of the Net Profits accruing during the Term.

 

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6.1.2    Payment of Royalties.

(a)    Following Commercial Launch, within sixty (60) days of the end of each
Calendar Quarter during the Term, EVL shall pay to Catalyst the Royalties
accrued during the preceding Calendar Quarter.

(b)    EVL shall, concurrently with payment of Royalties and in any event within
sixty (60) days of the end of each Calendar Quarter during the Term, provide to
Catalyst a written report (in the form attached as Exhibit B hereto) outlining
the details surrounding the calculation of Net Profits, Net Sales, deductions
from Net Profits and Net Sales and calculation of the Royalties due to Catalyst
pursuant to Section 6.1.1 (the “Net Profit Report”).

(c)    Subject to Section 6.1.2(d), EVL shall pay such amount relating to the
share of the Net Profit payable pursuant to Section 6.1.1 to Catalyst and set
forth in the Net Profit Report; provided, however, that in the event that the
amount otherwise payable under Section 6.1.1 equals a negative amount (“Negative
Amount”), then EVL shall be permitted to carry over such Negative Amount to
apply against future Calendar Quarters; provided, further, that if such Negative
Amount is not fully recovered within the following two Calendar Quarters or EVL
does not have continuing payment obligations pursuant to Section 6.1.1, then EVL
may invoice Catalyst for the unrecovered Negative Amount and Catalyst shall pay
such unrecovered Negative Amount to EVL within thirty (30) days of such invoice,
by wire transfer of immediately available funds to a bank account designated in
writing by EVL.

(d)    In the event there is a Negative Amount in two consecutive Calendar
Quarters, the JSC shall meet not later than ten (10) days after issuance of the
Net Profit Report for the second consecutive Calendar Quarter to discuss the
commercial viability of the Product and endeavor in good faith to reach
unanimous agreement with respect to the future Commercialization of the Product
under this Agreement. Should the JSC not be able to reach unanimous agreement
with respect to such future Commercialization within such ten (10) day period,
either Party may refer such matter for resolution to the Chief Executive Officer
of each Party and such Chief Executive Officers will attempt to resolve the
matter in good faith within ten (10) days after the JSC has failed to reach
unanimous agreement. In the event that the Chief Executive Officers cannot
resolve such matter within such ten (10) day period, Catalyst may, upon delivery
of written notice to EVL, terminate this Agreement effective as of the last day
of the calendar month following such written notice.

(e)    EVL shall make all payments under this Agreement free and clear of all
tax deductions and withholdings, unless any such tax deduction or withholding is
required by law in effect at the time of payment. Any Tax required to be
withheld on amounts payable under this Agreement by EVL to Catalyst will be paid
by EVL on behalf of Catalyst to the appropriate Governmental Authority, and EVL
will furnish Catalyst with official receipts evidencing the payment of such Tax.
Any such Tax required to be withheld will be treated as having been paid to
Catalyst for all purposes of this Agreement.

 

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6.2    Milestone Payment.

6.2.1    Subject to the terms and conditions of this Agreement, upon achievement
of certain milestones, EVL shall make milestone payments to Catalyst as set
forth below (each, a “Milestone Payment”). For the avoidance of doubt, each
Milestone Payment shall be payable one-time only upon the first occurrence of
the event triggering the respective milestone set forth below:

(a)    [***] ($[***]) upon execution of this Agreement by both Parties; and

(b)    [***] Dollars ($[***]) if upon Commercial Launch no Generic Equivalent
had been commercially sold in the Territory by or on behalf of a Third Party; or

(c)    [***] Dollars ($[***]) if upon Commercial Launch a Generic Equivalent had
already been commercially sold in the Territory by or on behalf of a Third
Party.

6.2.2    EVL shall make the applicable Milestone Payments payable to Catalyst
under Section 6.2.1 (as applicable) within thirty (30) days following the
completion of, and its receipt of an invoice for, the occurrence of the
corresponding event, except for the Milestone Payment under Section 6.2.1(a),
which shall be paid by EVL to Catalyst on the date hereof. Upon the occurrence
of the applicable event for which a Milestone Payment is due and payable,
Catalyst shall provide written notice thereof to EVL, along with an invoice for
the corresponding Milestone Payment; provided, however, that Catalyst shall not
be obligated to submit an invoice for the Milestone Payment under
Section 6.2.1(a).

6.3    Payment; Expenses.

6.3.1    All payments under this Article 6 shall be made by wire transfer of
immediately available funds to a bank account designated in writing by Catalyst.

6.3.2    Each Party shall bear its own costs and expenses associated with its
responsibilities under this Agreement, except as expressly set forth in this
Agreement. Any amounts payable under this Agreement which are not paid within
thirty (30) days of their due date shall bear interest at a rate equal to [***]
percent ([***]%) per annum, which shall be computed on the basis of a 365 day
year.

6.4    Records and Audits. EVL and its Affiliates shall keep and maintain or
cause to be maintained books and records pertaining to the calculation of Cost
of Goods Sold, Net Sales and Net Profits during the Term and for two (2) years
thereafter. Such books and records shall be maintained in accordance with GAAP
and with all records and details necessary to enable Catalyst to verify the
foregoing. All factors included in the determination of the Cost of Goods Sold,
Net Sales and Net Profits shall be specific to the Product, reasonably
documented, and available for independent audit purposes. Catalyst shall have
the right once per calendar year, at its own expense, during the Term and for
two (2) years thereafter, to have an independent public accountant, reasonably
acceptable to EVL, audit the relevant financial books and records of account of
EVL for up to the preceding three (3) years during normal business hours, upon
reasonable advance notice, to determine or verify the applicable Cost of Goods
Sold, Net Sales and Net Profits. If errors are found, any undisputed deficiency
shall be paid within sixty (60) days following delivery of written documentation
reasonably substantiating such deficiency. If errors

 

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are discovered as a result of such audit in Catalyst’s favor exceeding ten
percent (10%) of Net Profits for the period audited (which shall be no less than
one (1) year), EVL shall reimburse Catalyst for the reasonable expense of such
audit. In the event that there is any overpayment by EVL revealed (a) by an
examination and review conducted on behalf of Catalyst, or (b) by an examination
and review of a Net Profit Report by EVL’s accountants within one (1) year of
delivery of such Net Profit Report, then EVL shall be permitted to carry over
such overpayment and apply it against its payment obligations pursuant to
Section 6.1.1 for future Calendar Quarters; provided, however, that if such
overpayment is not fully recovered within the following two Calendar Quarters or
EVL does not have continuing payment obligations pursuant to Section 6.1.1, then
EVL may invoice Catalyst for the unrecovered overpayment and Catalyst shall pay
such unrecovered overpayment to EVL within thirty (30) days of such invoice, by
wire transfer of immediately available funds to a bank account designated in
writing by EVL.

6.5    Accounting.

(a)    The Parties acknowledge that any expenses or costs deducted from Net
Sales under this Agreement may be based upon accruals, which accruals will be
recognized and adjusted in compliance with GAAP; provided, however, that when
the actual results become known relative to any accrued amount, any difference
between the actual results and the accrual shall be accounted for in the
subsequent payments due hereunder (subject to customary processing delays).

(b)    To the extent that the difference between such accruals and the actual
results has led to an underpayment, EVL shall pay Catalyst the amount of such
underpayment on the next date payment is due to Catalyst hereunder. To the
extent that the difference between such accruals and the actual results has led
to an overpayment to Catalyst, EVL may, at its option, set-off such overpayments
against subsequent payments to be made to Catalyst or issue an invoice for the
amount of such overpayment, which shall be paid by Catalyst within forty-five
(45) days after Catalyst’s receipt thereof.

(c)    After the Term, EVL shall continue to reflect such deductions for
accruals, and by the date that is twenty-four (24) months following the
expiration of the Term or termination of this Agreement, as applicable, EVL
shall reconcile (and give to Catalyst a report of such reconciliation of) all
accrued calculations and deductions used in determining Net Sales with actual
processed credits. If the report shows an underpayment to Catalyst, EVL shall
pay Catalyst the amount of the underpayment at the time it gives the report to
Catalyst. If the report shows an overpayment to Catalyst, Catalyst shall pay EVL
the amount of the overpayment within thirty (30) days after receipt of such
reconciliation.

ARTICLE 7. INTELLECTUAL PROPERTY

7.1    General Ownership.

7.1.1    Except as expressly provided in this Agreement, each Party shall own
its own Intellectual Property consistent with United States or other applicable
international patent, trademark, and copyright law.

 

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7.1.2    Each Party that owns any particular Intellectual Property shall, as
between the Parties, have the sole and exclusive right to control the filing
for, prosecution, maintenance and enforcement of such Intellectual Property in
its sole discretion.

7.2    Product Intellectual Property.

7.2.1    EVL and Catalyst shall coordinate with each other with respect to
Intellectual Property matters, including strategic decisions relating to
potential Intellectual Property litigation and any other litigation arising from
or relating to the Product in the Territory.

7.2.2    Intellectual Property that is jointly invented or jointly conceived
during the Term under this Agreement shall be jointly owned by the Parties,
unless otherwise agreed in writing. Employees of Catalyst, whether serving as
advisors or consultants to EVL or serving EVL in any other capacity, shall be
considered employees of Catalyst for the purpose of determining ownership of
Intellectual Property.

7.2.3    For the avoidance of doubt, Intellectual Property covering inventions
or improvements that are created or conceived in the course of developing the
Product shall be owned solely by a Party if only its employees create or
conceive such invention or improvement.

7.3    Notification. The Parties shall promptly notify each other of any
allegation that any activity undertaken pursuant to this Agreement infringes or
may infringe the Intellectual Property rights of any Third Party. Each Party
shall assist and cooperate with the other Party in the defense of any Proceeding
relating to the Product (including consenting to being named as a nominal party
thereto).

ARTICLE 8. CONFIDENTIALITY AND PUBLIC DISCLOSURE

8.1    Treatment of Confidential Information.

A Receiving Party shall retain in strict confidence, and not disclose, divulge
or otherwise communicate to any other Person, any Confidential Information of
the Disclosing Party, whether received prior to or after the Effective Date, and
shall not use any such Confidential Information for any purpose, except pursuant
to the terms of, and as required to carry out such Receiving Party’s obligations
under, this Agreement, except that each Receiving Party may disclose
Confidential Information of the Disclosing Party to the officers, directors,
employees, agents, accountants, attorneys, consultants, subcontractors or other
representatives of the Receiving Party or its Affiliates (the “Representatives”)
who, in each case, (a) need to know such Confidential Information for the
limited purposes of the implementation and performance by the Receiving Party of
this Agreement, (b) will use the Confidential Information only for such limited
purposes, and (c) are bound by confidentiality obligations no less protective
than those set forth in this Agreement.

8.1.1    A Receiving Party shall use at least the same standard of care in
complying with its confidentiality obligations hereunder as it uses to protect
its own Confidential Information of comparable sensitivity and to prevent and
restrain the unauthorized disclosure of such Confidential Information by any of
its Representatives, but in no event less than a reasonable standard of care.
The Receiving Party shall be liable for any breach by any of its Representatives
of the restrictions set forth in this Agreement.

 

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8.1.2    Without limiting the generality of any of the foregoing, the Parties
shall not make any disclosure of Confidential Information that would be
reasonably likely to preclude the Disclosing Party from obtaining U.S. or
foreign patents on any patentable invention or discovery described or otherwise
embodied in such Party’s Confidential Information.

8.1.3    The Confidential Information of each Party includes information from
Third Parties subject to confidentiality restrictions and disclosed by one Party
to the other Party.

8.2    Release from Restrictions.

8.2.1    A Receiving Party may disclose Confidential Information to the extent
that such Confidential Information disclosure is made in response to a valid
order or subpoena of a court of competent jurisdiction in the Territory or other
Governmental Authority of competent jurisdiction or otherwise required by law,
in the reasonable opinion of counsel to the Receiving Party; provided, however,
that, to the extent practicable, the Receiving Party shall first provide written
notice to the Disclosing Party reasonably in advance under the circumstances in
order to give the Disclosing Party a reasonable opportunity to quash such order
or subpoena or to obtain a protective order requiring that the Confidential
Information or documents that are the subject of such order or subpoena to be
held in confidence by such court or Governmental Authority or, if disclosed, be
used only for the purposes for which such order or subpoena was issued; and
provided further that whether a disclosure order or subpoena is quashed or a
protective order is obtained, any Confidential Information that may be disclosed
in response to such court or Governmental Authority order or subpoena shall be
limited to information that, in the reasonable opinion of counsel to the
Receiving Party, is legally required to be disclosed in such response to such
order or subpoena.

8.2.2    A Receiving Party may also disclose Confidential Information to the
extent that such disclosure is made (i) to a Governmental Authority as required
in connection with any filing, application or request for Regulatory Approval
with respect to the Product, (ii) to comply with the reporting requirements of
any Applicable Laws or any securities exchange on which the securities of the
Receiving Party or its Affiliates are traded or (iii) to a Third Party to which
a Receiving Party has a contractual obligation related to the Product, but only
to the extent such information is required by such contractual obligation,
provided that in each case (clauses (i), (ii) and (iii)), reasonable measures
are taken to seek confidential treatment of such Confidential Information.

8.2.3    A Receiving Party may disclose this Agreement to a Third Party in
connection with or in conjunction with (i) a proposed merger, consolidation,
sale of assets that includes those related to this Agreement, (ii) a permitted
assignment of this Agreement or (iii) loan financing, raising of capital, or
sale of securities; provided, however, that the disclosing Party obtains an
agreement for confidential treatment thereof on terms no less protective than
those contained herein.

 

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8.2.4    Any Confidential Information disclosed pursuant to this Section 8.2
shall maintain its confidentiality protection and nonuse restrictions for all
purposes other than such disclosure.

8.3    No Implied Rights. Except as otherwise expressly set forth in this
Agreement, nothing herein shall be construed as granting any Receiving Party any
right, title, interest in or ownership of the Confidential Information,
proprietary information or Intellectual Property of the Disclosing Party. For
the avoidance of doubt, specific information disclosed as part of Confidential
Information shall not be deemed to be in the public domain or in the prior
possession of the Receiving Party merely because it is embraced by more general
information in the public domain or by more general information in the prior
possession of the Receiving Party.

8.4    Survival of Confidentiality Obligations. The confidentiality obligations
of the Parties contained in this Article 8 shall remain binding on both Parties
during the Term and for a period of five (5) years after the expiration of the
Term or the termination of this Agreement, regardless of the cause of such
expiration or termination.

8.5    Disclosure of Terms and Use of Party’s Name.

8.5.1    No press release, public announcement, confirmation or other
communication to the public or Third Parties regarding the existence or terms of
this Agreement or related matters shall be made by either Party without the
prior written consent of the other Party, including with respect to the form,
content and timing of such press release, public announcement, confirmation or
other communication to the public or Third Parties, except as provided
Section 8.2 or in the following sentence. The Parties agree that a press release
may be issued by Catalyst at or after the Effective Date in the form included on
Exhibit C and that the Parties may make communication of any information
specifically included in such press release.

8.5.2    Except as required by Applicable Laws or as to Labeling activities, no
right, express or implied, is granted by this Agreement to either Party to use
in any manner the name of the other Party or its Affiliates or any other trade
name or trademark of such other Party or its Affiliates in connection with the
performance of this Agreement. For clarity, it is understood that nothing herein
shall prohibit either Party from using the name of the other Party (i) in
certain of such Party’s disclosure documents, including those filed or disclosed
in order to comply with its obligations under Applicable Laws or the listing
standards or agreements of any national or international securities exchange,
The New York Stock Exchange or The NASDAQ Stock Market or other similar laws of
a Governmental Authority, (ii) to respond to an inquiry of a Governmental
Authority, or (iii) in a judicial, administrative or arbitration Proceeding, or
from disclosing the fact that it has granted or obtained a license to any
Intellectual Property of such other Party so long as such use of the other
Party’s name is limited to statements of fact and is not done in a manner to
suggest or imply endorsement by such other Party.

8.6    Third Party Information

8.6.1     Catalyst has not and shall not (i) violate or misappropriate the trade
secrets, know-how, or confidential information, or knowingly violate or
misappropriate any other proprietary rights, of any Third Party in developing
the Product, and will not communicate any

 

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Third Party trade secrets to EVL or its Affiliates in connection with its rights
and obligations under this Agreement without receiving permission from such
Third Party and informing EVL of communication of such trade secrets, or
(ii) provide or disclose any documents or information to EVL or its Affiliates
unless Catalyst is the owner thereof, or otherwise has the full and legal right
to do so.

8.6.2    EVL shall not (i) violate or misappropriate the trade secrets,
know-how, or confidential information, or knowingly violate or misappropriate
any other proprietary rights, of any Third Party in connection with its rights
and obligations under this Agreement, and will not communicate any Third Party
trade secrets to Catalyst in connection with its rights and obligations under
this Agreement without receiving permission from such Third Party and informing
Catalyst of communication of such trade secrets, or (ii) provide or disclose any
documents or information to Catalyst unless EVL is the owner thereof, or
otherwise has the full and legal right to do so.

8.7    Remedies. Each Party acknowledges and agrees that: (i) it will be too
speculative to measure the damages that would be suffered by the other Party if
such Party fails to comply with the obligations set forth in this Article 8 or
in Article 12 and that, in the event of any such failure, such other Party will
be irreparably harmed and will not have an adequate remedy at law, (ii) such
other Party shall, therefore, be entitled, in addition to any other rights and
remedies, to seek specific performance of such Party’s obligations and to seek
immediate injunctive relief without having to post a bond, and (iii) such
non-complying Party shall not assert, as a defense to any proceeding for such
specific performance or injunctive relief, that such other Party will not be
irreparably harmed or that such other Party has an adequate remedy at law.

ARTICLE 9. REPRESENTATIONS AND WARRANTIES AND COVENANTS

9.1    By EVL. EVL hereby represents, warrants and covenants that:

(a)    EVL is a company duly organized and validly existing under the laws of
Ireland;

(b)    EVL has the corporate power and authority to enter into and be bound by
the terms and conditions of this Agreement and to perform its obligations
hereunder and the execute this Agreement;

(c)    EVL has taken all necessary corporate action on its part to authorize the
execution and delivery of this Agreement and this Agreement has been duly
executed and delivered on behalf of EVL and constitutes a legal, valid, binding
obligation, enforceable against EVL in accordance with its terms, subject to
bankruptcy, insolvency, reorganization, moratorium or other similar laws
affecting the enforceability of creditors’ rights generally and other general
equitable principles which may limit the right to obtain certain remedies;

(d)    EVL is subject to no legal, contractual or other restrictions,
limitations or conditions that conflict with its rights and obligations under
this Agreement or that might affect adversely its ability to perform hereunder,
including Section 2.2;

 

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(e)    EVL has not misappropriated and will not misappropriate trade secrets of
any Third Party in the provision of services and the performance of its
obligations under this Agreement or otherwise in connection with the Product;

(f)    EVL itself or through its Affiliates has maintained and will maintain
appropriate skilled personnel and facilities to carry out its obligations under
this Agreement;

(g)    No EVL employees or other Persons performing services on behalf of EVL
under this Agreement have been debarred, or are the subject of debarment
Proceedings, under Section 306 of the FD&C Act; and if EVL becomes aware that a
Person performing on its behalf under this Agreement has been debarred, or has
become the subject of debarment Proceedings, under Section 306 of the FD&C Act,
EVL shall promptly notify Catalyst and shall prohibit such Person from
performing on its behalf under this Agreement; and

(h)    EVL and its Affiliates have not and shall not (i) promise, offer, or give
anything of value to any government employee or individual acting in an official
capacity for the purpose of securing any improper or undue advantage,
(ii) accept or receive any unlawful contributions, payments, expenditures, or
gifts, (iii) do business with any person that is the subject of sanctions
imposed or administered by the U.S. Treasury Department’s Office of Foreign
Assets Control or the UN Security Council or any governmental agency in a
jurisdiction in which EVL and its Affiliates are organized or doing business,
and EVL and its Affiliates are not the subject of any such sanctions, or
(iv) violate any applicable export restriction, anti-boycott regulation, or
other applicable laws.

9.2    By Catalyst. Catalyst hereby represents, warrants and covenants that:

(a)    Catalyst is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its formation;

(b)    Catalyst has the corporate power and authority to enter into and be bound
by the terms and conditions of this Agreement and to perform its obligations
hereunder;

(c)    Catalyst has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and this Agreement has
been duly executed and delivered on behalf of Catalyst and constitutes a legal,
valid, binding obligation, enforceable against Catalyst in accordance with its
terms, subject to bankruptcy, insolvency, reorganization, moratorium or other
similar laws affecting the enforceability of creditors’ rights generally and
other general equitable principles which may limit the right to obtain certain
remedies;

(d)    Catalyst is subject to no legal, contractual or other restrictions,
limitations or conditions which conflict with either of its rights and
obligations under this Agreement or which might affect adversely its ability to
perform hereunder, including Section 2.2;

(e)    Catalyst has not misappropriated and will not misappropriate trade
secrets of any Third Party in the provision of services and the performance of
its obligations under this Agreement or otherwise in connection with the
Product;

 

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(f)    Catalyst has maintained and will maintain appropriate skilled personnel
and facilities to carry out its obligations under this Agreement, consistent
with prudent business practices of Catalyst;

(g)    No Catalyst employees or other Persons performing services on behalf of
Catalyst under this Agreement have been debarred, or are the subject of
debarment Proceedings, under Section 306 of the FD&C Act; and if Catalyst
becomes aware that a Person performing on its behalf under this Agreement has
been debarred, or has become the subject of debarment Proceedings, under
Section 306 of the FD&C Act, Catalyst shall promptly notify EVL and shall
prohibit such Person from performing on its behalf under this Agreement;

(h)    Catalyst and its Affiliates have not and shall not (i) promise, offer, or
give anything of value to any government employee or individual acting in an
official capacity for the purpose of securing any improper or undue advantage,
(ii) accept or receive any unlawful contributions, payments, expenditures, or
gifts, (iii) do business with any person that is the subject of sanctions
imposed or administered by the U.S. Treasury Department’s Office of Foreign
Assets Control or the UN Security Council or any governmental agency in a
jurisdiction in which Catalyst and its Affiliates are organized or doing
business, and Catalyst and its Affiliates are not the subject of any such
sanctions, or (iv) violate any applicable export restriction, anti-boycott
regulation, or other Applicable Laws;

(i)    All Bioequivalence Studies were conducted in accordance with all
Applicable Laws (which the Parties acknowledge does not include the draft FDA
guidance otherwise related to such studies); and

(j)    [***].

9.3    Compliance with Laws.

9.3.1    Anti-Corruption Laws. Each Party represents and warrants to the other
Party that, to the knowledge of such Party, such Party, with respect to the
conduct of its business as of the Effective Date, has been and is in compliance
in all material respects with all Applicable Laws. Each Party shall comply, and
shall cause its employees and subcontractors to comply, with all Applicable Laws
in its performance of activities contemplated under this Agreement. Without
limiting the generality of the foregoing, each Party agrees that it will comply
with, and will not take any action that will cause the other Party or its
Affiliates to be in breach of all Applicable Laws for the prevention of fraud,
kickbacks, bribery, corruption, racketeering, money laundering or terrorism,
including the FCPA, each, as amended from time to time (collectively,
“Anti-Corruption Laws”). Each Party agrees that it has not, and covenants that
it will not, in connection with the performance of this Agreement, give,
promise, authorize, ratify or offer, or take any act in furtherance of offering
or giving anything of value, directly or indirectly: (i) to any individual,
including Government Officials; or (ii) to an intermediary for payment to any
individual, including Government Officials; (iii) or to any sick fund, health
insurer or Healthcare Professional or employee or officer of such sick fund,
health insurer or Healthcare Professional; or (iv) to any political party. It is
the intent of the Parties that no payments or transfers of value shall be made,
promised, authorized, ratified or offered with the purpose or effect of public
or commercial bribery, acceptance or acquiescence in extortion, kickbacks or
other unlawful or improper means of security an improper advantage or obtaining
or retaining business.

 

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9.3.2    Data Protection Laws. From time to time during the Term, either Party
may provide the other Party with personal information that falls under the
protection of certain data security and privacy laws (“Protected Personal
Information”). Each Party agrees to comply with all Applicable Laws relating to
the use, storage, collection or other processing of such Protected Personal
Information, including without implied limitation the General Data Protection
Regulation (EU) 2016/679 of the European Parliament and of the Council of
27 April 2016 on the protection of natural persons with regard to the processing
of personal data and on the free movement of such data, and repealing Directive
95/46/EC (“Data Protection Laws”). The Parties agree to use good-faith efforts
to agree upon and implement any security protocols and information handling
guidelines that such Party’s legal advisors recommend in connection with such
Party’s compliance with such Data Protection Laws.

9.3.3    OFAC Compliance. Each Party acknowledges and expressly agrees that
certain laws of the United States of America and other countries, including,
without limitation, the United States Export Control Regulations, the United
States Anti-Money Laundering laws, the United States Anti-Terrorism laws and the
FCPA, and U.S. sanctions programs administered by the Office of Foreign Assets
Control (“OFAC”) and the Bureau of Industry and Security, among others, may
result in the imposition of sanctions on the other Party or its Affiliates in
the event that, directly or indirectly, products are exported to or imported
from, or payments are sent to or received from various countries or regions,
including, without limitation, Iran, North Korea, Syria, Sudan, the Crimea
region of Ukraine, or any country embargoed by Executive Order or otherwise, or
to or from certain individuals designated or identified as sanctioned by the
U.S. government, including persons in Russia and Ukraine. Each Party warrants
that it has searched OFAC’s Consolidated Sanctions List, available at
https://sdnsearch.ofac.treas.gov, in order to ensure compliance with all
applicable sanctions regulations.

9.3.4    Compliance Event Reporting. Each Party agrees that if it learns of any
violation of Data Protection Laws, Applicable Laws, Export Control Laws or
Anti-Corruption Laws by an employee or sub-contractor that performs any function
under this Agreement (a “Compliance Event”), it will immediately notify the
other Party in writing of such Compliance Event and the measures it has taken
and intends to take to remedy such Compliance Event and to prevent its
recurrence.

ARTICLE 10. INDEMNIFICATION

10.1    Indemnification by Catalyst. Subject to Section 10.3, Catalyst shall
defend, indemnify and hold harmless each of EVL and its Affiliates, and each of
their respective directors, officers and employees (each, an “EVL Indemnitee”)
from and against any and all liabilities, damages, settlements, penalties,
fines, costs or expenses (including reasonable attorneys’ fees and other
expenses of litigation) (collectively, “Liabilities”) arising, directly or
indirectly, out of or in connection with Third Party claims, suits, actions,
demands or judgments to the extent arising out of or relating to (i) any breach
by Catalyst of any representation, warranty, agreement, undertaking or covenant
under this Agreement; (ii) any negligence, gross negligence or willful
misconduct by Catalyst or its Affiliates, past or present employees or agents;
(iii) any arrangement entered into

 

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by Catalyst (or its Affiliates) and a Third Party, providing for any royalty or
other payment obligation with respect to the Product, or (iv) any patient’s
participation in the Bioequivalence Studies, except, in each case, for those
Liabilities for which EVL has an obligation to indemnify the Catalyst
Indemnitees pursuant to Section 10.2, as to which Liabilities each Party shall
indemnify the other Party to the extent of its respective liability for such
Liabilities.

10.2    Indemnification by EVL. Subject to Section 10.3, EVL shall defend,
indemnify and hold harmless each of Catalyst and its Affiliates, and each of
their respective directors, officers and employees (each, a “Catalyst
Indemnitee”) from and against any and all Liabilities arising, directly or
indirectly, out of or in connection with Third Party claims, suits, actions,
demands or judgments to the extent arising out of or relating to (i) any breach
by EVL of any representation, warranty, agreement, undertaking or covenant under
this Agreement; (ii) any negligence, gross negligence or willful misconduct by
EVL or its Affiliates or sublicensees, past or present employees or agents; or
(iii) product liability claims arising from the manufacture of the Product by
EVL or its Affiliates, except, in each case, for those Liabilities for which
Catalyst has an obligation to indemnify the EVL Indemnitees pursuant to
Section 10.1, as to which Liabilities each Party shall indemnify the other Party
to the extent of its respective liability for such Liabilities.

10.3    Notice and Procedures. If a Catalyst Indemnitee or an EVL Indemnitee
(the “Indemnitee”) intends to claim indemnification under this Article 10, it
shall promptly notify the other Party (the “Indemnitor”) in writing of any such
alleged Liabilities. The failure to deliver written notice to the Indemnitor
within a reasonable time after the commencement of any claim or action shall not
relieve the Indemnitor of any obligation to the Indemnitee under this
Section 10.3 except to the extent that the Indemnitor is materially prejudiced
by such delay.

10.3.1    In the event that the Indemnitor does not assume and pursue in a
timely and diligent manner the defense of any Third Party claim (but in no event
later than thirty (30) days, or such shorter period as required under Applicable
Laws), then the Indemnitor shall be deemed to have ceded control of such claim
and the Indemnitee shall be entitled to appoint counsel of its own choice for
such defense, at the cost and expense of the Indemnitor.

10.3.2    In the event that the Indemnitor assumes such defense, the Indemnitor
shall have the right to control the defense thereof with counsel of its choice,
provided that such counsel is reasonably acceptable to Indemnitee; and provided
further that any Indemnitee shall have the right to retain its own counsel at
its own expense, for any reason, including if representation of the Indemnitee
by the counsel retained by the Indemnitor would be inappropriate due to actual
or potential conflicts or differing interests between such Indemnitee and such
Indemnitor reasonably represented by such counsel in such proceeding. The
Indemnitee, its employees and agents, shall reasonably cooperate with the
Indemnitor and its legal representatives in the investigation of any Liabilities
covered by this Article 10.

10.3.3    The obligations of this Section 10.3 shall not apply to amounts paid
in settlement of any claim, demand, action or other proceeding if such
settlement is effected without the consent of the Indemnitor (unless the
Indemnitor is deemed to have ceded control of the applicable Third Party claim
under this Section 10.3).

 

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10.3.4    Only Catalyst or EVL may claim indemnity under this Article 10 (on its
own behalf or on behalf of its Indemnitees), and other Persons may not directly
claim indemnity hereunder.

10.4    Other Product Liability Claims. To the extent either Party incurs any
Liabilities arising from or in connection with any product liability claim with
respect to the Product to the extent arising from the actions not subject to the
indemnity obligations set forth in Section 10.1 or Section 10.2 (a “Product
Claim”), then each Party shall be liable for such portion of the Liabilities in
accordance with such Party’s allocation of the Net Profits pursuant to
Section 6.1.1; provided, however, such Liabilities shall be shared initially by
offsetting against the portion of Net Profits otherwise payable or retained
pursuant to Section 6.1.1 and in the event of any shortfall thereafter, each
Party’s share thereof shall be paid in accordance with such allocation. EVL
shall have sole control in addressing, defending, managing and conducting any
negotiations, litigation, threatened litigation or settlement regarding such
Product Claim, using counsel of its choice. In the event that EVL does not
respond to the Product Claim against Catalyst within (a) sixty (60) days
following the notice of such claim or (b) ten (10) days before the time limit,
if any, set forth in the appropriate laws and regulations for the filing of a
response to such Product Claim, whichever comes first, Catalyst shall have the
right to control any such Product Claim, using counsel of its own choice. In the
event of a Product Claim, the non-controlling Party shall cooperate fully with
the controlling Party, including, if a party in such Product Claim, and the
controlling Party shall keep the non-controlling Party and/or the
non-controlling Party’s designated legal counsel reasonably informed as to the
progress of such action. Neither Party shall enter into any settlement of the
Product Claim, without the prior written consent of the other, such consent not
to be unreasonably withheld, delayed or conditioned. Notwithstanding this
Section 10.4, (a) Catalyst’s maximum aggregate liability pursuant to this
Section 10.4 shall not exceed an amount equal to $[***], and (b) Catalyst shall
have no liability under this Section 10.4 for product liability claims arising
from the manufacture of the Product by any manufacturer other than [***].

10.5    Exclusive Remedy. The rights of the EVL Indemnitees and the Catalyst
Indemnitees under this Article 10 shall be the sole and exclusive remedy of the
EVL Indemnitees and the Catalyst Indemnitees, as the case may be, with respect
to matters covered hereunder other than as provided in Article 8 and the
termination provisions of Article 12.

ARTICLE 11. LIMITATION OF LIABILITY

NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, EXCEPT WITH RESPECT
TO A BREACH OF ARTICLE 8 AND EXCEPT WITH RESPECT TO AMOUNTS PAYABLE ON
LIABILITIES PURSUANT TO THE INDEMNIFICATION OBLIGATIONS SET FORTH IN ARTICLE 10,
NO PARTY SHALL BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL OR
INDIRECT DAMAGES, INCLUDING FOR LOST PROFITS, OR LOSS OF OPPORTUNITY OR USE OF
ANY KIND SUFFERED BY THE A PARTY, WHETHER IN CONTRACT, TORT OR OTHERWISE.

 

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ARTICLE 12. TERM AND TERMINATION

12.1    Term. Unless earlier terminated pursuant to this Article 12, the term of
this Agreement shall continue in force from the Effective Date until the date
that is ten (10) years following the Commercial Launch (the “Term”).

12.2    Termination for Breach. Either Party may terminate this Agreement, or
suspend performance under this Agreement upon written notice to the other Party
at any time during the Term, if the other Party is in material breach of this
Agreement and such other Party has not cured such material breach within sixty
(60) days after notice requesting cure of such breach; provided, however, that
if such breach is not capable of cure within sixty (60) days, but is capable of
cure, and the breaching Party has promptly commenced, and is and continues
diligently pursuing in good faith the remedy of any such breach, then such cure
period shall be extended for such period as may be reasonably required to
effectuate such cure.

12.3    Termination for Insolvency. Either Party may terminate this Agreement in
the event that the other Party suffers an Insolvency Event, by delivery of
written notice thereof by the other Party.

12.4    Termination for Force Majeure Event. Either Party may terminate this
Agreement pursuant to and in accordance with Section 14.12 in connection a Force
Majeure Event.

12.5    Termination for Other Events. The applicable Party may terminate this
Agreement upon delivery of written notice to the other Party as follows:

(a)    EVL may terminate this Agreement if the [***] has not been approved by
the FDA by January 1, 2021;

(b)    EVL may terminate this Agreement upon EVL’s reasonable determination that
the Product is not commercially viable; or

(c)    Catalyst may terminate this Agreement if the Commercial Launch has not
occurred within 24 months of the [***] having been approved by the FDA, unless
the failure to launch arises out of or is related to an Interfering Event.

12.6    Effect of Expiration or Termination.

12.6.1    Expiration of the Term or termination of this Agreement for any reason
shall be without prejudice to:

(a)    Each Party’s right to receive all payments due and payable from the other
Party as of the effective date of such termination, if any, pursuant to the
terms of this Agreement;

(b)    EVL’s right to sell, at its option but subject to the Commercial Launch,
the Product remaining in its inventory at the time of termination (in which
event, Net Profits on such sales shall continue to be shared as set forth above
in Section 6.1.1) for up to twelve (12) months following the time of termination
(and any remaining unsold inventory shall be destroyed by EVL or its Affiliates)
provided that Catalyst or its assigns may elect to purchase from EVL the
saleable inventory of the Product at EVL’s Acquisition Cost; and

 

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(c)    any other legal, equitable, or administrative remedies as to which either
Party is or may become entitled.

12.6.2    In the event that this Agreement is terminated by Catalyst pursuant to
Section 12.4 or EVL pursuant to Section 12.5(a) or Section 12.5(b), such
termination shall automatically result in an offer by EVL to transfer its right,
title, interest, ownership and control of the [***] and any and all other assets
owned by EVL or its Affiliates related solely to the Product (other than assets
that bear EVL’s or any of its Affiliate’s name or logo) to Catalyst or its
designee free and clear of any adverse claims, liens or payment obligations; and
Catalyst or its designee shall have the right, at its sole discretion, to accept
such offer by delivering written notice thereof within twenty (20) Business Days
following the date of such notice. In the event of such acceptance, (i) Catalyst
shall, subject to Section 12.7 (as applicable), (x) in the event Catalyst elects
to continue the Commercialization (at its sole discretion), be responsible for,
at its own expense, all activities in connection with such Commercialization, as
well as any Liabilities deriving therefrom, including the obligation to defend,
indemnify and hold harmless each EVL Indemnitee from any Liabilities asserted
against EVL for such Commercialization by Catalyst or its designated Affiliate,
and (y) make a payment to EVL in an amount equal to [***] Dollars ($[***])
within five (5) days of completion of [***] from EVL or its Affiliate to
Catalyst or its designee; (ii) EVL shall have no further obligation to indemnify
a Catalyst Indemnitee pursuant to Section 10.2 for events occurring after the
aforementioned [***] pursuant to this Section 12.6.2 except such indemnification
obligations shall remain for Product sold by EVL, its Affiliates or
sublicensees; and (iii) the license granted by Catalyst to EVL pursuant to
Section 2.1.1 shall terminate. Each Party shall reasonably cooperate with each
other in connection herewith, including (i) negotiating in good faith
appropriate documentation addressing the provisions in this Section 12.6.2, (ii)
filing a transfer of ownership letters as required by 21 CFR § 314.72, in forms
mutually agreed between Catalyst and EVL, to effectuate the [***] from EVL or
its Affiliate to Catalyst or its designee, and (iii) using commercially
reasonable efforts to complete the [***] from EVL or its Affiliate to Catalyst
or its designee as soon as practicable, but in any event within forty-five
(45) days of Catalyst’s acceptance of EVL’s offer pursuant to this
Section 12.6.2.

12.6.3    In the event that the Agreement is terminated by Catalyst pursuant to
Section 12.2, Section 12.3 or Section 12.5(c), (i) EVL shall, for no additional
consideration, transfer its right, title, interest, ownership and control of the
[***] and any and all other assets owned by EVL or its Affiliates related solely
to the Product (other than assets that bear EVL’s or any of its Affiliate’s name
or logo) to Catalyst or its designee, (ii) in the event Catalyst elects to
continue the Commercialization (at its sole discretion), Catalyst shall, subject
to Section 12.7 (as applicable), be responsible for, at its own expense, all
activities in connection with such Commercialization, as well as any Liabilities
deriving therefrom, including the obligation to defend, indemnify and hold
harmless each EVL Indemnitee from any Liabilities asserted against EVL for such
Commercialization by Catalyst or its designated Affiliate, (iii) EVL shall have
no further obligation to indemnify a Catalyst Indemnitee pursuant to
Section 10.2 for events occurring after the aforementioned [***] pursuant to
this Section 12.6.3,

 

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except such indemnification obligations shall remain for Product sold by EVL,
its Affiliates or sublicensees; and (iv) the license granted by Catalyst to EVL
pursuant to Section 2.1.1 shall terminate. Each Party shall reasonably cooperate
with each other in connection herewith, including (i) negotiating in good faith
appropriate documentation addressing the provisions in this Section 12.6.3, (ii)
filing a transfer of ownership letters as required by 21 CFR § 314.72, in forms
mutually agreed between Catalyst and EVL, to effectuate the [***] from EVL or
its Affiliate to Catalyst or its designee, and (iii) using commercially
reasonable efforts to complete the [***] a from EVL or its Affiliate to Catalyst
or its designee as soon as practicable, but in any event within forty-five
(45) days of such termination of this Agreement.

12.6.4    In the event that the Term of the Agreement expires, or EVL wishes to
terminate this Agreement pursuant to Section 12.2 or Section 12.3, then (i) EVL
shall retain its right, title, interest, ownership and/or control of the [***],
and (ii) the license granted by Catalyst to EVL pursuant to Section 2.1.1 shall
continue in full force and effect.

12.6.5    All licenses and rights to licenses granted under or pursuant to this
Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of
rights to “intellectual property” as defined under Section 101(35A) of the Code.
EVL, as the licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the Code, and upon
commencement of a bankruptcy proceeding by or against Catalyst under the Code,
shall be entitled to a complete duplicate of, or complete access to (as EVL
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 EVL (i) upon any such commencement of a
bankruptcy proceeding upon written request therefor by EVL, unless Catalyst
elects to continue to perform all of its obligations under this Agreement or
(ii) if not delivered under (i) above, upon the rejection of this Agreement by
or on behalf of Catalyst, upon written request therefor by EVL, and each Party
hereby acknowledges and agrees that the foregoing shall serve as its consent to
such transfer of the intellectual property and all embodiments thereof. The
foregoing provisions of this Section 12.6.4 are without prejudice to any rights
EVL may have arising under the Code or other Applicable Law.

12.7    Survival. In addition to specific indications throughout this Agreement
that Articles and Sections of this Agreement shall survive expiration and
termination of this Agreement, Article 1, Article 8, Article 10, Article 11,
Article 12, Article 13, and Article 14, and Section 4.1.1, Section 6.3,
Section 6.4, Section 6.5, and Section 7.1, and any other provisions necessary
and proper to give effect to the intention of the Parties as to the effect of
the Agreement after termination shall survive any expiration or termination of
this Agreement. In addition, unless otherwise expressly set forth herein, no
expiration of the Term or termination of this Agreement shall have any effect on
any payment, obligation accruing or arising prior to such expiration or
termination or relieve either Party from obligations that are expressly
indicated to survive termination or expiration of this Agreement.

 

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ARTICLE 13. INSURANCE

13.1    Insurance

13.1.1    Each Party shall obtain and maintain at all times during the Term,
prudent comprehensive general liability coverage appropriate to its activities
with reputable and financially secure insurance carriers to cover its activities
related to this Agreement. Additionally such insurance coverage shall include
product liability coverage of an appropriate amount, not less than [***] US
dollars ($[***]) per occurrence, for so long as the Product is being sold
pursuant to this Agreement. Notwithstanding the foregoing, each Party shall, at
its own cost and expense, obtain and maintain in full force and effect at all
times during the Term, and (with respect to claims made insurance) for a period
of six (6) years thereafter:

(a)    commercial general liability insurance covering bodily injury and
property damage with limits no less than [***] Dollars ($[****]) per occurrence
and [***] Dollars ($[***]) in the aggregate; and

(b)    products and completed operations liability insurance (including coverage
for all Product used in clinical trials) with limits no less than [***] Dollars
($[***]) per occurrence and [***] Dollars ($[***]) in the aggregate.

13.1.2    All of the foregoing insurance policies shall be obtained from an
insurance carrier or carriers having a current A.M. Best rating of at least A-
Class VIII.

13.1.3    Upon written request, a Party shall provide the other Party with a
certificate of insurance evidencing such coverage. Each Party shall provide the
other Party with written notice within thirty (30) days of any material change
in the terms or coverage of such insurance policies or their lapse, cancellation
or termination.

13.1.4    All insurance policies obtained by either Party pursuant to this
Agreement shall be primary and not contributing to any other insurance,
self-insurance or captive insurance maintained by the other party to the extent
of such Party’s indemnification obligations hereunder; provided, however, that
notwithstanding the foregoing, (a) EVL may self-insure with respect to its
product liability obligations hereunder, and (b) the insurance policies required
under Section 13.1.1 shall not be construed to limit either Party’s liability
with respect to its indemnification obligations under this Agreement.

ARTICLE 14. MISCELLANEOUS

14.1    Interpretation and Construction. Unless the context of this Agreement
otherwise requires, (i) the terms “include,” “includes,” or “including” shall be
deemed to be followed by the words “without limitation” unless otherwise
indicated; (ii) words using the singular or plural number also include the
other, (iii) the terms “hereof,” “herein,” “hereby,” and derivative or similar
words refer to this entire Agreement; (iv) the terms “Article,” “Section” and
“Exhibit” refer to the specified Article, Section and Exhibit of this Agreement,
and (v) words of any gender include each other gender. Whenever this Agreement
refers to a number of days, unless otherwise specified, such number shall refer
to calendar days. The headings and paragraph captions in this Agreement are for
reference and convenience purposes only and shall not affect the meaning or
interpretation of this Agreement. This Agreement shall not be interpreted or
constructed in favor of or against either Party because of its effort in
preparing it.

 

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14.2    Independent Contractor Status. It is understood and agreed that nothing
in this Agreement nor any agreement related hereto is intended to nor shall
create a partnership between the Parties. The Parties are independent
contractors and are engaged in the operation of their own respective businesses,
and neither Party is to be considered the agent, partner, joint venturer or
employee of the other Party for any purpose whatsoever and neither Party shall
have any authority to enter into any contracts or assume any obligations for the
other Party nor make any representations or warranties on behalf of such other
Party.

14.3    Performance by Affiliates.

14.3.1    Catalyst recognizes that EVL may perform some or all of its
obligations under this Agreement through one (1) or more of its Affiliates;
provided, however, that EVL shall remain responsible for such performance by its
Affiliates and shall cause its Affiliates to comply with the provisions of this
Agreement in connection with such performance as if it were a party hereto.

14.3.2    In connection therewith, EVL may in its discretion have all or some of
EVL’s obligations and duties hereunder, including the commercialization of the
Product in the Territory, be fulfilled by one or more of EVL’s Affiliates,
without any further action or notice. Without limiting the foregoing, any
obligation or duty of EVL which is performed, satisfied or fulfilled by an
Affiliate of EVL shall be deemed to have been performed, satisfied or fulfilled
by EVL. EVL shall cause all of its Affiliates involved in any activities in
connection with this Agreement to comply in all respects with all terms and
conditions of this Agreement, and any breach by any such Affiliate of any of the
terms of this Agreement shall be deemed a breach by EVL.

14.4    Waiver. The waiver by either Party of a breach of any term or provision
contained herein shall not be effective unless provided in writing and shall in
no way be construed as a waiver of any succeeding breach of such term or
provision or the waiver of such term or provision itself.

14.5    Assignment. This Agreement shall be binding upon and inure to the
benefit of each of the Parties and their respective successors and approved
assigns; provided, however, that neither Party may assign this Agreement, in
whole or in part, without the prior written consent of the other Party, unless
such assignment is (i) to an Affiliate of the assigning Party, or (ii) in
connection with a merger or acquisition or sale of all or substantially all of
the assets of the assigning Party to which this Agreement relates; provided
further, however, that notwithstanding the foregoing, each Party shall provide
written notice (at least ten (10) days in the event of clause (i)) of any
assignment of this Agreement in accordance with the terms hereof to the other
Party. Any assignment of this Agreement not in accordance with this provision
shall be null and void ab initio.

14.6    Modification. This Agreement may not be changed, modified, amended or
supplemented except by an express written instrument signed by both Parties.

 

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14.7    Severability. If any provision of this Agreement shall be held illegal
or unenforceable, that provision shall be limited or eliminated to the minimum
extent necessary so that this Agreement shall otherwise remain in full force and
effect and enforceable.

14.8    Further Assurances. Each Party shall execute, acknowledge and deliver
such further instruments and documents, and to do all such other acts, as may be
reasonably necessary or appropriate in order to carry out the purposes and
intent of this Agreement.

14.9    Notices.

14.9.1    Any notice or other communication to be given under this Agreement by
any Party to the other Party shall be in writing and shall be either
(a) personally delivered, (b) mailed by registered or certified mail, postage
prepaid with return receipt requested, (c) delivered by overnight express
delivery service or same-day local courier service, or (d) delivered by
facsimile transmission (followed by a copy by the preceding methods in clause
(a), (b) or (c)), to the email address of the applicable Party as set forth
below, or to such other address as may be designated by the Parties from time to
time in accordance with this Section 14.9.

14.9.2    Notices delivered personally, by overnight express delivery service or
by local courier service shall be deemed given as of actual receipt. Mailed
notices shall be deemed given three (3) Business Days after mailing. Notices
delivered by facsimile transmission shall be deemed given upon receipt by the
sender of the transmission confirmation (in the case of a facsimile
transmission) if transmitted before 5:00 p.m. (recipient’s local time) on a
Business Day, and otherwise on the following Business Day.

 

If to EVL:     

Endo Ventures Limited

First Floor, Minerva House

Simmonscourt Road

Ballsbridge

Dublin 4

Attention: Senior Vice President, Head of International

Pharmaceuticals

Email: garella.rahul@endo.com

Facsimile Number: +353 1 268 2029

With a copy to:     

Par Pharmaceutical, Inc.

6 Ram Ridge Road

Chestnut Ridge, NY 10977

Attention: Legal

Email: Par.NoticeDept@parpharm.com

Facsimile Number: (845) 573-5600

If to Catalyst:     

Catalyst Pharmaceuticals Inc.

355 Alhambra Circle, Suite 1250

Coral Gables, FL, USA 33134

Attention: Brian Elsbernd, Senior Vice President of Legal

and Compliance

Email: belsbernd@catalystpharma.com

Facsimile Number: (305) 569-0233

 

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14.10    Governing Law and Jurisdiction. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York, without
reference to the choice of law principles thereof other than those that may
permit designation of New York law. The Parties irrevocably agree that the State
and Federal Courts located in the State, City, and County of New York, shall
have exclusive jurisdiction to deal with any disputes arising out of or in
connection with this Agreement and that venue is proper in such Courts. Each
Party hereby expressly consents and submits to the personal jurisdiction of the
Federal and State Courts in the State, City and County of New York.

14.11    Attorney Fees. In the event that either Party institutes any legal
suit, action, or proceeding against the other Party arising out of this
Agreement, the prevailing Party in the suit, action or proceeding shall be
entitled to receive, in addition to all other damages to which it may be
entitled, the costs incurred by such party in conducting the suit, action, or
proceeding, including reasonable attorneys’ fees and expenses and court costs.

14.12    Force Majeure. A Party shall not be liable for non-performance or delay
in performance of its obligations hereunder to the extent that and solely for so
long as such non-performance or delay in performance is not due to its
negligence or breach of this Agreement and is caused by any event reasonably
beyond the control of such Party, including wars, hostilities, revolutions,
riots, civil commotion, national emergency, unavailability of supplies,
epidemics, fire, flood, earthquake, force of nature, explosion, terrorist act,
embargo, or any other Act of God, or any law, proclamation, regulation,
ordinance, or other act or order of any court or Governmental Authority (each, a
“Force Majeure Event”). In the event of any such Force Majeure Event, the
delayed Party may defer its performance for the duration of such Force Majeure
Event, provided that the delayed Party gives the other Party written notice
thereof promptly and, in any event, within two (2) Business Days of discovery
thereof, and uses its good faith efforts to cure the excused breach. If either
Party is unable to perform its obligations hereunder as a result of a Force
Majeure Event for a period of ninety (90) days or longer and is not continuously
exercising diligent good faith efforts to remedy, overcome or work around the
Force Majeure Event, then the other Party shall have the right, upon its
issuance of written notice to the other Party, to terminate this Agreement.

14.13    Entire Agreement. This Agreement and any Exhibits attached hereto
constitute the entire agreement between EVL and Catalyst with respect to the
Product and supersede all prior representations, understandings and agreements
with respect to the Product. In the event of a conflict between this Agreement
and any Exhibits attached hereto, this Agreement shall prevail over any such
Exhibit.

14.14    Counterparts. This Agreement may be executed in one or more
counterparts, including by transmission of facsimile or PDF copies of signature
pages, each of which shall for all purposes are deemed to be an original and all
of which shall constitute one instrument.

 

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14.15    Third Party Beneficiaries. Except as provided in Section 10.1 and
Section 10.2, (i) no term or provision of this Agreement is intended to be, or
shall be, for the benefit of any Person (including any sub-contractor, or any
individual member of the control group utilized for the bioequivalence studies)
that is not a party hereto, and (ii) no such other Person shall have any right
or cause of action hereunder.

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

[Signature page follows]

 

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IN WITNESS WHEREOF, the Parties hereto have executed this Development, License
and Commercialization Agreement to be effective as of the Effective Date.

 

ENDO VENTURES LIMITED By:  

/s/ Rahul Garella

  Name:   Rahul Garella   Title:   SVP International Pharmaceuticals

 

CATALYST PHARMACEUTICALS INC. By:  

/s/ Patrick J. McEnany

  Name:   Patrick J. McEnany   Title:   Chief Executive Officer

 

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Exhibit A

[***]

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Exhibit B

FORM OF

NET PROFIT REPORT

[***]

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Exhibit C

FORM OF PRESS RELEASE

CATALYST PHARMACEUTICALS ANNOUNCES DEFINITIVE AGREEMENT WITH

ENDO FOR VIGABATRIN TABLETS

CORAL GABLES, Fla., December XX, 2018 (GLOBE NEWSWIRE) — Catalyst
Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company
focused on developing and commercializing innovative therapies for people with
rare debilitating, chronic neuromuscular and neurological diseases, today
announced that it has signed a Definitive Agreement with Endo International
plc’s (NASDAQ: ENDP) subsidiary, Endo Ventures Limited, for the further
development and commercialization of generic Sabril® (vigabatrin) tablets
through Endo’s U.S. Generic Pharmaceuticals segment, doing business as Par
Pharmaceutical. Pursuant to the agreement, Catalyst will receive an up-front
payment, milestone payments based on achievement of regulatory approvals, and a
sharing of defined net profits upon commercialization.

“We are very happy to work with Endo, to bring generic Sabril® tablets to
market. Endo is an established leader in the generic vigabatrin marketplace,”
said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst
Pharmaceuticals. “Our search for an appropriate partner for this product was
long but rewarding with this result. We look forward to bringing to market this
important medication to improve the lives of patients.”

“Generic vigabatrin tablets will complement our current powder vigabatrin
offering and will expand the number of patients that can benefit from having
access to a high-quality, generic vigabatrin option,” said Brandon Rockwell,
Senior Vice President, Business Development and Strategy of Endo.

Vigabatrin comes in two dosage forms – a powder sachet and a tablet. Par
Pharmaceutical brought the first generic version of the powder sachet to market
but at this time there is no approved generic version of the tablets.

About Catalyst Pharmaceutical

Catalyst Pharmaceutical is a biopharmaceutical company focused on developing and
commercializing innovative therapies for people with rare debilitating, chronic
neuromuscular and neurological diseases, including LEMS, congenital myasthenic
syndromes (CMS), MuSK antibody positive myasthenia gravis (MuSK-MG), and spinal
muscular atrophy (SMA) type 3. Catalyst’s new drug application for Firdapse®
(amifampridine) 10 mg tablets for the treatment of adults with Lambert-Eaton
Myasthenic Syndrome (LEMS) was recently approved by the U.S. Food & Drug
Administration (“FDA”), and Firdapse® is expected to be commercially available
in the United States early in the first quarter of 2019. Prior to its approval,
Firdapse for LEMS had received breakthrough therapy designation and orphan drug
designation from the FDA.

Firdapse® is currently being evaluated in clinical trials for the treatment of
CMS, MuSK-MG and SMA type 3 and has received Orphan Drug Designation from the
FDA for CMS and myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the
first and only approved drug in Europe for the symptomatic treatment in adults
with LEMS.

 

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About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty
branded pharmaceutical company delivering quality medicines to patients in need
through excellence in development, manufacturing and commercialization. Endo has
global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA.
Learn more at www.endo.com.

About Par Pharmaceutical

Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures
and markets safe, innovative and cost-effective generic pharmaceutical products
that help improve patient quality of life. Par, among the top leaders in the
U.S. generics industry, possesses a portfolio that includes sterile injectables,
alternative dosage forms and many other differentiated products. Par is
advancing a research and development (R&D) pipeline of approximately 200
potential new products. Par is an operating company of Endo International plc.
Learn more at www.parpharm.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties, which may cause
Catalyst’s actual results in future periods to differ materially from forecasted
results. A number of factors, including (i) whether the milestone payments that
are to be paid under Catalyst’s agreement with Endo will ever be earned and
paid; (ii) whether an ANDA for generic vigabatrin tablets will ever be approved
by the FDA; (iii) whether Endo, even if vigabatrin tablets are approved for
commercialization, will be successful in marketing the product, (iv) whether
Catalyst will earn royalties on sales of generic vigabatrin tablets; (v) whether
Catalyst can successfully market Firdapse and become profitable; (vi) whether
Firdapse will ever be approved for the treatment of CMS, MuSK-MG, SMA type 3, or
any other disease; and (vii) those other factors described in Catalyst’s Annual
Report on Form 10-K for the fiscal year 2017 and its other filings with the U.S.
Securities and Exchange Commission (SEC), could adversely affect Catalyst.
Copies of Catalyst’s filings with the SEC are available from the SEC, may be
found on Catalyst’s website, or may be obtained upon request from Catalyst.
Catalyst does not undertake any obligation to update the information contained
herein, which speaks only as of this date.

 

Investor Contact

Brian Korb

Solebury Trout

(646) 378-2923

bkorb@troutgroup.com

  

Company Contact

Patrick J. McEnany

Catalyst Pharmaceuticals

Chief Executive Officer

(305) 420-3200

pmcenany@catalystpharma.com

Media Contact

David Schull

Russo Partners

(212) 845-4271

david.schull@russopartnersllc.com

  

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