Exhibit 10.34

 

EXECUTION COPY

 

LICENSE, COMMERCIALIZATION AND OPTION AGREEMENT

 

This License, Commercialization and Option Agreement (“Agreement”) is made and
entered into as of March 16, 2017 (the “Effective Date”) by and between
MainPointe Pharmaceuticals, LLC, with offices at 333 East Main Street, Suite
220, Louisville, Kentucky 40202 (“MainPointe”), and Acura Pharmaceuticals, Inc.,
with offices at 616 N. North Court, Palatine IL 60067 (“Acura”). MainPointe and
Acura each are referred to herein as a “Party” and collectively as the
“Parties.”

 

WITNESSETH:

 

WHEREAS, Acura has developed Impede® Technology intended to prevent extraction
of pseudoephedrine from tablets and to disrupt the direct conversion of
pseudoephedrine from tablets into methamphetamine;

 

WHEREAS, MainPointe and its Affiliates have substantial expertise in the
distribution, sales and marketing of healthcare products worldwide;

 

WHEREAS, Acura wishes to grant to MainPointe, and MainPointe wishes to obtain,
the rights to the Impede® Technology to commercialize the Nexafed® Products in
the Territory (each as herein defined) and develop, obtain regulatory approval
and commercialize the Option Products in the Territory (as herein defined) upon
exercise as provided herein;

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:

 

ARTICLE I – DEFINITIONS

 

1.1           “Acquisition” is defined in Section 3.1.

 

1.2           “Acquisition Payment” means the payment by MainPointe to Acura on
the Effective Date for the Acquired Assets, as set forth in Section 4.1.1(B).

 

1.3           “Additional Nexafed Products” means any product having the same
active ingredients as a Currently Marketed Nexafed Product except that it
contains a dosage of greater than 60mg of PSE.

 

1.4           “Advertising Materials” is defined in Section 3.2(d).

 

1.5           “Affiliate” means any corporation or other entity, which directly
or indirectly controls, is controlled by or is under common control with a
Party. A corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls more than
Fifty Percent (50%) of the voting stock or other ownership interest of the other
corporation or entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the corporation
or other entity or the power to elect or appoint more than Fifty Percent (50%)
of the members of the governing body of the corporation or other entity.
Notwithstanding the foregoing, a private equity or venture capital firm with an
ownership interest in an entity shall not be an Affiliate by reason of such
ownership and portfolio companies of a private equity firm or a venture capital
firm shall not be Affiliates or a Party by virtue of the private equity firm or
venture capital firm being Affiliates of a Party.

 

 

 

 

1.6           “Applicable Law” means, with respect to any Person, any domestic
or foreign, federal, state or local statute, treaty, law, ordinance, rule,
regulation, administrative interpretation, order, writ, injunction, judicial
decision, decree or other requirement of any governmental authority, including
any rules, regulations or other requirements of the Regulatory Authorities in
the Territory, applicable to such Person or any of such Person’s respective
properties, assets, officers, directors, employees, consultants or agents.

 

1.7           “APT” means Acura Pharmaceutical Technologies, Inc.

 

1.8           “Assignment of Contracts” means the assignment of contracts in the
form of Exhibit A.

 

1.9           “Assumed Liabilities” is defined in Section 3.3.

 

1.10         “Assumption Agreement” means the assumption agreement in the form
of Exhibit B executed by MainPointe to evidence its assumption of the Assumed
Liabilities.

 

1.11         “Bayer” means Bayer Healthcare LLC.

 

1.12         “Bayer Agreement” means that certain License and Development
Agreement dated as of June 5, 2015 between Acura and Bayer HealthCare LLC, as
the same may be amended.

 

1.13         “Bill of Sale” means a bill of sale and assignment with respect to
the Acquired Assets in the form of Exhibit C.

 

1.14         “Claims” is defined in Section 6.3.

 

1.15         “Code” is defined in Section 4.9.6.

 

1.16         “Commercially Reasonable Efforts” means the efforts and resources
which would be used (including the promptness in which such efforts and
resources would be applied) by MainPointe consistent with its normal business
practices and in compliance with Applicable Law and the exercise of prudent
scientific and business judgment, which in no event shall be less than the level
of efforts and resources standard in the pharmaceutical industry for a company
similar in size and scope to MainPointe, with respect to a product or potential
product at a similar stage in its development and with similar market potential
or product life cycle taking into account efficacy, safety, commercial value,
the competitiveness of alternative products of Third Parties that are in the
marketplace, and the Patent Rights and other proprietary position of such
product.

 

1.17         “Confidential Information” is defined in Section 5.1 below.

 

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1.18         “Competing Product” means a prescription or over-the-counter
(non-prescription) product that contains PSE and has some effectiveness in
reducing the mean total recovery of methamphetamine from a pharmaceutical
product, other than a Product.

 

1.19         “Contracts” is defined in Section 3.2.1.

 

1.20         “Control” means, with respect to Intellectual Property Rights,
ownership or the possession of the ability by license or otherwise to assign or
grant a license or sublicense to or disclose such Intellectual Property Rights
without violating the terms of any agreement or other arrangement, express or
implied, with any Third Party.

 

1.21         “Currently Marketed Nexafed Products” means (i) Pseudoephedrine HCl
30 mg (currently marketed as Nexafed®) and (ii) Pseudoephedrine HCl 30 mg and
Acetaminophen 325 mg (currently marketed as Nexafed® Sinus Pressure + Pain).

 

1.22         “Effective Date” has the meaning set forth above.

 

1.23         “Excluded Liability” is defined in Section 3.4.

 

1.24         “Excluded Tax Liability” is defined in Section 3.4.

 

1.25         “FD&C Act” means that federal statute entitled the Federal Food,
Drug, and Cosmetic Act and enacted in 1938 as Public Law 75-717, as such may
have been amended, and which is contained in Title 21 of the C.F.R. Section 301
et seq.

 

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

 

1.27         “Field” means over-the-counter (non-prescription) (“OTC”) and
prescription (“Rx”) products.

 

1.28         “GAAP” means generally accepted accounting principles in effect in
the United States from time to time applied on a consistent basis.

 

1.29         “Gross Sales” means the U.S. Dollar value (with sales in foreign
currency converted as per Section 4.7) of all consideration to which MainPointe,
its Affiliates and licensees is entitled for the sale of Products. In the event
MainPointe sells Products for less than fair market value, the fair market value
of such Products (as if there had been a sale for fair market value to a Third
Party) shall be included in Gross Sales.

 

1.30         “Impede® Patent Rights” means the Patent Rights set forth on
Exhibit D, that disclose or claim Acura’s Impede® Technology and that are
Controlled by Acura or its Affiliates during the Term, including issued patents
resulting from such applications, and all divisions, continuations,
continuations-in-part, substitutions, reissues, reexaminations, extensions,
registrations, patent term extensions and renewals of the foregoing.

 

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1.31         “Impede® Technology” means the technology for reducing the recovery
of methamphetamine from a pharmaceutical product as reflected in the Impede
Patent® Rights and any related Know-How that is Controlled by Acura as of the
Effective Date or at any time during the Term, including (i) Impede 1.0 and
Impede 2.0 (as such terms Impede 1.0 and Impede 2.0 are described in Acura’s
filings with the Securities and Exchange Commission on or prior to the Effective
Date) and (ii) technology for reducing the recovery of methamphetamine from a
pharmaceutical product Controlled by Acura during the Term that would infringe
the Impede® Patent Rights if utilized by a third party.

 

1.32         “Infringing Competing Product” means a prescription or
over-the-counter (non-prescription) product that contains loratadine (or
desloratadine) in combination with PSE and infringes the Impede® Patent Rights.

 

1.33         “Intellectual Property Rights” means Know-How, registered
trademarks, trademark applications, unregistered trademarks, trade dress,
copyrights, and Patent Rights.

 

1.34         “Know-How” means information Controlled by Acura and related to
minimizing the extraction and conversion of pseudoephedrine into methamphetamine
and encompassing manufacturing techniques, process, quality information, batch
records (un-redacted master and executed), formulation composition and excipient
specifications, formation development reports; batch summaries, and analytical
methods and development/validation.

 

1.35         “Liabilities” is defined in Section 3.3.

 

1.36         “Losses” is defined in Section 6.3.

 

1.37         “NDC” is defined in Section 3.3(h).

 

1.38         “Net Sales” means the “Gross Sales” (as hereinafter defined),
reduced by deductions, without duplication, for each of the following to the
extent actually incurred, allowed or accrued, and without duplication (a)
returns, (b) cash discounts, (c) coupons, (d) listing fees, (e) credits, (f)
trade rebates, (g) shipping costs, (h) sales and excise taxes, other consumption
taxes, and (i) other governmental charges. Net Sales, as set forth in this
definition, shall be calculated applying, in accordance with GAAP, MainPointe's
standard accounting practices for selling MainPointe's other products.

 

1.39         “Nexafed Products” means (i) Pseudoephedrine HCl 30 mg (currently
marketed as Nexafed®) and (ii) Pseudoephedrine HCl 30 mg and Acetaminophen 325
mg (currently marketed as Nexafed® Sinus Pressure + Pain), and (iii) any
products (other than Additional Nexafed Products) containing the same active
ingredients as the Nexafed Products, and utilizing the Impede Technology, with
60 mg or less of PSE.

 

1.40         “Option Product” means (a) the Additional Nexafed Products and (b)
a prescription or over-the-counter tablet product containing PSE as an active
pharmaceutical ingredient, alone or in combination with other active
pharmaceutical ingredients and utilizing the Impede Technology, other than
Nexafed Products, provided that an Option Product shall cease to be an Option
Product if its status as such is terminated under Section 2.3.2. All strengths
of an Option Product shall be considered the same Option Product. An Infringing
Competing Product is not an Option Product.

 

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1.41         “Option Product Exercise Fee” is defined in Section 2.3.

 

1.42         “Option Territory Exercise Fee” is defined in Section 2.2.

 

1.43         “Other Transaction Documents” means the Assumption Agreement, Bill
of Sale and the Assignment of Contracts.

 

1.44         “Paragraph IV Certification” means a certification under and
pursuant to 21 U.S.C. Section 355(j)(2)(A)(vii)(IV) of the FD&C Act or pursuant
to 21 U.S.C. Section 355(b)(2) (A)(iv) of the FD&C Act.

 

1.45         “Patent Challenge” is defined in Section 10.3.

 

1.46         “Patent Rights” means patents and patent applications, and all
divisionals, continuations, continuations in part, reissues, extensions,
supplementary protection certificates and foreign counterparts thereof.

 

1.47         “Person” means an individual, a corporation, a general partnership,
a limited partnership, a limited liability company, a limited liability
partnership, an association, a trust or any other entity or organization.

 

1.48         “Pre-Closing Tax Period” is defined in Section 4.9.

 

1.49         “Post-Closing Tax Period” is defined in Section 4.9.

 

1.50         “Prior Confidentiality Agreement” is defined in Section 5.4.

 

1.51         “Product” means a Nexafed Product or an Option Product for which
MainPointe has exercised an option pursuant to Section 2.3.

 

1.52         “PSE” means pseudoephedrine or a pharmaceutically acceptable salt
thereof.

 

1.53         “Regulatory Approval” means the license or final FDA, or equivalent
foreign governmental authority, marketing approval necessary as a prerequisite
for marketing a Product in a country in the Territory.

 

1.54         “Regulatory Approval Application” means shall mean any filing(s)
made with the Regulatory Authority in any country in the Territory for
Regulatory Approval of the marketing, manufacture and sale (and pricing when
applicable) of a Product in such country.

 

1.55         “Regulatory Authority” means the FDA in the U.S., and any health
regulatory authority(ies) in any other country in the Territory that is a
counterpart to the FDA and has responsibility for granting regulatory approval
for the marketing, manufacture, and sale of a Product in such country,
including, but not limited to, pricing and reimbursement approvals, and any
successor(s) thereto, as well as any state or local health regulatory
authorities having jurisdiction over any activities contemplated by the Parties.

 

1.56         “Royalty Payment” is defined in Section 4.2.1.

 

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1.57         “Royalty Report” is defined in Section 4.3.

 

1.58         “Royalty Term” shall be on a Product-by-Product and
country-by-country basis and, with respect to each country, will begin on the
Effective Date and will expire on the later of the date that (i) the Impede®
Patent Rights in such country are not Valid; or (ii) is the scheduled expiration
of the Royalty Term for the United States for a country in which there are not
any Impede® Patent Rights, provided that all Royalty Terms shall terminate upon
termination of this Agreement pursuant to Section 10.2.

 

1.59         “Straddle Period” is defined in Section 4.9.5.

 

1.60         “Tax” or “Taxes” is defined in Section 4.9.6.

 

1.61         “Term” has the meaning set forth in Section 10.1.

 

1.62         “Territory” means the United States and Canada, and with respect to
each Product, on a Product by Product basis, such additional regions/countries
as may be added pursuant to Section 2.2.

 

1.63         “Third Party” means any entity other than Acura and its Affiliates
and MainPointe and its Affiliates.

 

1.64         “Transfer Taxes” is defined in Section 3.3(g).

 

1.65         “Transferred Contracts” is defined in Section 3.2.1.

 

1.66         “Transferred Advertising Materials” is defined in Section 3.2(d).

 

1.67         “Transferred Inventory” is defined in Section 3.2.1.

 

1.68         “Transition Contracts” is defined in Section 4.13.

 

1.69         “Transition Products” is defined in Section 4.13.

 

1.70         “Upfront License Payment” is defined in Section 4.1.1.

 

1.71         “Valid” means, with respect to a Impede® Patent Rights in a
particular country, such Impede® Patent Rights have not (A) expired or been
cancelled, (B) been declared invalid or unenforceable by a decision of a court
or other appropriate body of competent jurisdiction, from which no appeal is or
can be taken, (C) been admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise, or (D) been abandoned or disclaimed either
affirmatively or by operation of law.

 

ARTICLE II – LICENSE AND COMMERCIALIZATION

 

2.1         License.

 

2.1.1           Acura hereby grants MainPointe an exclusive (even as to Acura),
sub-licensable (subject to Section 2.10), royalty-bearing right and license
under the Impede® Technology and to the Nexafed® trademark to develop,
manufacture, have manufactured, distribute, have distributed, sell, have sold,
market, have marketed, commercialize and have commercialized the Product(s) in
the Field in the Territory.

 

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2.1.2           Acura hereby licenses to MainPointe, on a non-exclusive basis
the use of the mark Impede® in the Field and Territory solely for the
commercialization of a Product, provided that such mark shall be exclusive in
the Territory for all Products containing PSE as an active ingredient in dosage
strengths of 60 mg or less, and utilizing the Impede Technology.

 

2.1.3           The licenses granted herein shall expire upon termination of
this Agreement but shall survive expiration of this Agreement.

 

2.2         Option to Expand Definition of Territory.

 

At any time during the Royalty Term for the United States, MainPointe, by
written notice to Acura may expand the definition of Territory to include a
region/country in the table below (one fee for all Nexafed Products) if such
notice is accompanied by payment in immediately available funds of the sum of
the (i) option/exercise fee opposite such region/country in the table below
(“Option Territory Exercise Fee”) plus (ii) a $250,000 for each Product that was
formerly an Option Product. The $250,000 payment is a one-time payment for each
Product that was formerly an Option Product regardless of the region or country
added to the Territory.

 

Region/Country  Option Territory Exercise Fee  European Union and United
Kingdom  $1,000,000  Japan  $500,000  South Korea  $250,000 

 

All such fees are non-refundable and non-creditable.

 

2.3         Option to Expand Definition of Product.

 

2.3.1           At any time during the Royalty Term for the United States, if
MainPointe desires to add an Option Product to this Agreement during the Royalty
Term for the United States, MainPointe shall send written notice to Acura,
provided MainPointe shall not have the right to add a product whose status as an
Option Product was previously terminated under Section 2.3.2. Acura shall have
thirty (30) days from receipt of such notice to reject the addition of such
Option Product in accordance with the immediately preceding sentence if and only
if rights to such Option Product have been granted by Acura to Bayer under the
Bayer Agreement, as in effect on the date hereof or if adding the Option Product
to this Agreement would be in violation of the Bayer Agreement, as in effect on
the date hereof (as reasonably determined by Acura). Any rejection shall be
accompanied by an explanation and indicate when, if ever, it may be possible to
add the proposed Option Product. If not rejected by Acura within such thirty
(30) day period, in accordance with the immediately preceding sentence, such
Option Product shall be added to this Agreement as a Product provided MainPointe
remits to Acura $500,000; provided, however, that if prior to Acura’s acceptance
of such Option Product MainPointe had exercised its option right to expand the
Territory and had not remitted to Acura the $250,000 payment provided in Section
2.2(ii), MainPointe’s payment to Acura shall be increased from $500,000 to
$750,000. Such payment shall be in immediately available funds within five (5)
days of or the conclusion of such thirty (30) day period (or, if earlier, the
date of acceptance by Acura), provided further that if MainPointe does not remit
payment within such time period, MainPointe must repeat the procedure of this
Section 2.3.1 to add such Option Product as a Product under this Agreement. All
such fees are non-refundable and non-creditable.

 

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2.3.2           During the Royalty Term for the United States, if Acura receives
a Third Party expression of interest to develop, license, collaborate or acquire
an Option Product, and in each case Acura determines to license to, develop with
or for, or collaborate with a Third Party with respect to or sell such Option
Product, then it will send MainPointe written notice of same, before offering
such Option Product to any Third Party. Acura’s notice shall contain such
information as MainPointe shall reasonably require to evaluate such product
(which shall be subject to the protections of Article V (confidentiality)
hereof). If MainPointe wishes to add the Option Product as a Product hereunder,
MainPointe shall send Acura a written notice exercising its option to add such
Option Product as a Product hereunder, accompanied by the Option Product
Exercise Fee within forty five (45) days of receipt of Acura’s notice and
supporting information. If MainPointe does not exercise its option within such
forty-five (45) day period then Acura and its Affiliates shall be free to
negotiate with any Third Party and enter into an agreement relating to such
Option Product and MainPointe shall have no rights thereto and such Option
Product shall cease being an Option Product under this Agreement. For the
avoidance of doubt, Acura shall not be required to provide any notice to
MainPointe under this Section 2.3.2, except as required under Section 11.5, in
connection with its undergoing or completing a change of control transaction, or
a sale of all or substantially all of its line of business which includes an
Option Product. This Section 2.3.2 shall not survive termination or expiration
of this Agreement.

 

2.4         No Other Rights and Retained Rights.

 

This Agreement confers no right, license or interest by implication, estoppel,
or otherwise under any Patent Rights, Confidential Information, Know-How or
other Intellectual Property Rights (including but not limited to trade secrets,
formulations, manufacturing processes, data) that was owned by a Party prior to
signing the Agreement except as expressly set forth in this Article II. Each
Party hereby expressly retains and reserves all rights and interests with
respect to patents, Confidential Information, technology or other Intellectual
Property Rights not expressly granted to the other Party hereunder.

 

2.5         MainPointe to use CRE. MainPointe shall use Commercially Reasonable
Efforts to market and sell the Currently Marketed Nexafed Products in the
Territory and to develop, obtain any necessary Regulatory Approval for, and
commercialize other Products in the Territory. MainPointe shall comply with all
Applicable Laws in the development, commercialization (including, without
limitation, packaging, sale, distribution, advertising, disposition and
marketing of the Product and product packaging) and MainPointe shall use all
legends, notices, and markings as required by Applicable Law.

 

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2.6         MainPointe Responsibility for All Costs and Expenses. During the
Term, MainPointe shall have the sole obligation and responsibility, and at its
sole cost and expense, for all aspects of development, regulatory activities,
manufacturing and commercializing, including without limitation, testing
packaging and labelling Product, and any costs associated with storage, release
and Third Party logistics. As part of such responsibilities, MainPointe shall
have the sole responsibility to obtain or to coordinate with and provide to its
contract manufacturer such information and materials as shall be reasonably
necessary to obtain sufficient quota for active pharmaceutical ingredients from
the Drug Enforcement Administration, and similar foreign agencies.

 

2.7         Regulatory Approvals and Fees. MainPointe shall be the sole owner of
the Product Regulatory Approvals, registration materials, clinical
documentation, and any and all country specific dossiers for Products in the
Territory other than Currently Marketed Nexafed Products for the United States.
Acura shall be sole owner of the Currently Marketed Nexafed Product Regulatory
Approvals, registration materials, clinical documentation, and any and all
country specific dossiers for Currently Marketed Nexafed Products. MainPointe
shall be responsible for maintaining Product Regulatory Approvals and pay any
and all fees and expenses in connection therewith including, without limitation,
any filing fees, establishment fees, annual product fees, active pharmaceutical
supplier fees, and any fees associated with the amendment of a Regulatory
Approval, any costs and expenses associated with regulatory changes requested by
a Regulatory Authority relating to a Product, or the Product Regulatory
Approvals.

 

2.8         Right of Reference.

 

2.8.1           Acura grants MainPointe a right of reference to preclinical and
clinical data and reports, and any adverse event reports regarding the Products
and all other necessary data, reports and information, in each case Controlled
by Acura for the purpose of obtaining, and/or maintaining Regulatory Approval
of, or commercializing or manufacturing a Product, without any additional
compensation.

 

2.8.2           MainPointe grants Acura a perpetual right of reference to
preclinical and clinical data and reports, any adverse event reports regarding
the Products and such other data, reports and information, in each case
Controlled by MainPointe for the purpose of obtaining and/or maintaining
Regulatory Approval of products utilizing the Impede Technology, without any
additional compensation.

 

2.9         Non-Compete. MainPointe will not develop, file a Regulatory Approval
Application or seek Regulatory Approval of or launch, market or sell or assist a
Third Party in the development of, launch, market or sale of an Infringing
Competing Product or a Competing Product in a country in the Territory during
the Royalty Term for such country.

 

2.10       Sublicenses. MainPointe may grant sublicenses through multiple tiers,
under any or all of the rights granted in Section 2.1, to its Affiliates and to
Third Parties. Each agreement in which MainPointe grants a sublicense under
Section 2.1 shall be consistent with the relevant terms and conditions of this
Agreement. MainPointe shall provide notice to Acura of the proposed sublicense
prior to execution thereof which notice shall state the subject of the
sublicense (including the portion of the Territory and products being
sublicensed) and MainPointe shall provide Acura a copy of such sublicense, with
suitable redaction of confidential information contained therein, within thirty
(30) days after execution thereof. MainPointe shall be and remain fully
responsible for the compliance by sublicensees with the terms and conditions of
this Agreement, including without limitation and non-compete provisions of
Section 2.9.

 

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2.11       Technology Transfer. Promptly after the Effective Date, Acura shall
provide MainPointe with a technology transfer which shall consist of the
manufacturing Know-How encompassed in the Impede Technology relating to the
Currently Marketed Nexafed Products.

 

2.12       Records. MainPointe shall have the right to copies of all customers’
and suppliers’ lists, other distribution lists of Acura and APT that relate
exclusively to the Currently Marketed Nexafed Products, in each case in
existence on the Effective Date and within the possession and control of Acura.

 

2.13       Complaints; Recalls. Each of MainPointe and Acura shall inform the
other Party as promptly as practicable of any Product complaints, including
Product returns for which the other Party bears financial or regulatory
responsibility. All communications relating to the performance or condition of a
Product, and all communications relating to adverse experiences in association
with, but not necessarily due to, a Product which are received by Acura or
MainPointe shall be forwarded to the other Party. In the event of any recall of
or field notification after the Effective Date with respect to any Product, each
of MainPointe and Acura shall make available to the other Party during normal
business hours and upon reasonable advance notice such records and other
information as reasonably requested by such other Party in connection with any
recall of the Products after the Effective Date. MainPointe shall be solely
responsible at its cost and expense for any recalls or withdrawals of Product
sold by it or Transferred Inventory and Acura shall be solely responsible at its
cost and expense for any recalls or withdrawals of Product sold by it.
MainPointe shall be responsible for all required regulatory activities in the
Territory.

 

2.14       Trademarks; Logos.

 

2.14.1         MainPointe shall assume full responsibility, at its sole cost and
expense, for prosecuting or litigating any infringement of the Nexafed trademark
and shall be entitled to retain all recoveries in connection therewith except it
shall remit to Acura 7.5% of such recoveries after deduction from such
recoveries of fees and expenses in enforcing such trademark rights.

 

2.14.2         MainPointe hereby acknowledges the exclusive ownership of Acura
of the Nexafed trademark furnished by Acura for use in connection with the
Nexafed Products and Impede trademarks furnished by Acura (or its Affiliates)
for use in connection with the Products. MainPointe shall not, during the Term
or thereafter, register, use, or attempt to obtain any right in and to the
Nexafed trademark or Impede trademark or in and to any name, logo or trademark
confusingly similar thereto, including (i) any mark that begins with the prefix
AC or AK and ends with the suffix FED or PHED, (ii) SUDAFED; and (iii) any mark
that begins with the prefix SU or CU and ends with the suffix FED or PHED.

 

2.14.3         Acura shall have the right to exercise quality control over
MainPointe's use of the Impede and Nexafed trademarks, as applicable, to a
degree reasonably necessary to maintain the validity of those trademarks, as
applicable, and to protect the goodwill associated therewith.

 

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2.14.4         MainPointe shall, in its packaging, sale, marketing, advertising,
disposition and distribution of any Product and product packaging adhere to a
level of quality regarding the maintenance of the validity of the Impede and
Nexafed trademarks, as applicable, and the protection of the goodwill associated
therewith consistent with the reasonable standards of quality otherwise set by
Acura.

 

ARTICLE III – ASSET CONVEYANCE

 

3.1         Upon the terms and subject to the conditions set forth in this
Agreement, on the Effective Date, Acura shall, and shall cause APT to, sell,
assign, transfer, convey and deliver to MainPointe, and MainPointe shall
purchase from Acura and APT all the right, title and interest of Acura and APT
in, to and under the Acquired Assets and MainPointe shall assume the Assumed
Liabilities (each as defined below). On the Effective Date each Party shall
execute the Other Transaction Documents which calls for its signature. The
purchase and sale of the Acquired Assets and the assumption of the Assumed
Liabilities are referred to in this Agreement collectively as the “Acquisition”.

 

3.2         Transfer of Assets.

 

3.2.1           The term “Acquired Assets” means all of Acura’s and APT’s right,
title and interest in, to and under those certain assets identified below:

 

(a)all finished goods, raw materials (including all bulk active pharmaceutical
ingredients for each of the Nexafed Products), work-in-progress, components,
packaging and labeling material, supplies and other inventories (including items
in transit, on consignment, or covered by open purchase orders or in the
possession of any Third Party) of the Nexafed Products of Acura and APT on the
Effective Date that relate exclusively to the Nexafed Products, in each case
listed on Schedule 3.2.1(a) (collectively, the “Transferred Inventory”).

 

(b)the equipment identified on Schedule 3.2.1(b);

 

(c)the written contracts, indentures, licenses, agreements, commitments and all
other legally binding arrangements, (“Contracts”) identified on Schedule
3.2.1(c) and (B) the binding purchase orders to which Acura or APT is a party
that relate exclusively to the Nexafed Products identified on Schedule 3.2.1(c),
(collectively, the “Transferred Contracts”); provided, however, that Transferred
Contracts shall not include any contract except those expressly set forth on
schedule 3.2.1(c); and

 

(d)all domain names, brochures, promotional and printed materials, tradeshow
materials (including displays), videos, advertising materials, marketing
materials, package inserts and packaging materials (in all cases, in any form or
medium) (“Advertising Materials”), if any, owned by Acura or APT and related
exclusively to the commercialization of the Nexafed Products (“Transferred
Advertising Materials”), provided Acura’s name shall be deleted therefrom, as
provide in Section 9.5.

  

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3.3         Assumed Liabilities. Upon the terms and subject to the conditions of
this Agreement, MainPointe shall assume, effective as of 12:00:01 a.m. on the
Effective Date, and from and after the Effective Date, MainPointe shall pay,
perform and discharge when due, the following liabilities, obligations and
commitments (“Liabilities”) of Acura and APT, other than such Liabilities that
constitute an Excluded Liability (the “Assumed Liabilities”):

 

(a)all Liabilities of Acura and APT under or otherwise arising out of or
relating to the Transferred Contracts (including all Liabilities arising out of
or relating to any termination by or at the request of MainPointe or
announcement or notification by or at the request of MainPointe of an intent to
terminate any such contract), to the extent the event, circumstance, condition,
action or inaction giving rise thereto occurs (i) on or after the Effective Date
or (ii) relates to the Transferred Inventory or any Product sold by or
manufactured for MainPointe;

 

(b)all accounts payable, accrued expenses and other current liabilities relating
to the Acquired Assets or the Products to the extent arising on or after the
Effective Date;

 

(c)all Liabilities arising out of or relating to any lawsuits, claims, actions
or proceedings relating to the manufacture, production, marketing,
commercialization, distribution or sale of the Products or the ownership, sale,
lease or use of any of the Acquired Assets to the extent the same relates to the
Transferred Inventory or any Product sold by or manufactured for MainPointe on
or after the Effective Date or MainPointe's actions or inactions after the
Effective Date; provided, however, that in the case any such Liability relates
to Transferred Inventory, subject to Section 2.13, only to the extent such
Liability does not arise out of or is otherwise attributable to Acura’s or APTs,
or their respective agent’s manufacture or direct or indirect handling, storage,
alteration, treatment or other use or possession of such Transferred Inventory
prior to the Effective Date;

 

(d)all Liabilities for warranty claims and product liability or similar claims,
including all suits, actions or proceedings relating to any such Liabilities,
relating to the Transferred Inventory or any Products sold or marketed on or
after the Effective Date or MainPointe's actions or inactions after the
Effective Date; provided, however, that in the case any such Liability relates
to Transferred Inventory, subject to Section 2.13, only to the extent such
Liability does not arise out of or is otherwise attributable to Acura’s or APTs,
or their respective agent’s manufacture or direct or indirect handling, storage,
alteration, treatment or other use or possession of such Transferred Inventory
prior to the Effective Date;

 

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(e)except as otherwise contemplated by Section 4.10, all Liabilities arising out
of or relating to the return of, or refund, adjustment, allowance or exchange in
respect of, the Products, whether arising before, or on or after the Effective
Date;

 

(f)all Liabilities for Taxes arising out of or relating to or in respect of the
Products or any Acquired Asset for any Post-Closing Tax Period, other than any
Excluded Tax Liabilities;

 

(g)all Liabilities for transfer, documentary, sales, use, registration,
value-added and other similar Taxes and related amounts (including any
penalties, interest and additions to Tax) incurred in connection with this
Agreement, any of the Other Transaction Documents, the Acquisition and the other
transactions contemplated hereby and thereby (“Transfer Taxes”); and

 

(h)except as otherwise contemplated by Section 4.10, all Liabilities arising
from the sale from and after the Effective Date of the Nexafed Products in each
case as a result of such Products bearing Acura’s National Drug Code (“NDC”)
number.

 

Each of MainPointe's and Acura’s obligations under this Section 3.3 will not be
subject to offset or reduction by reason of any actual or alleged breach of any
representation, warranty, covenant or agreement contained in this Agreement or
any Other Transaction Document or any right or alleged right to indemnification
hereunder.

 

3.4         Excluded Liabilities. Notwithstanding any other provision of this
Agreement, MainPointe shall not assume any Excluded Liability, each of which
shall be retained and paid, performed and discharged when due by Acura and APT.
The term “Excluded Liability” shall mean all Liabilities other than Assumed
Liabilities and shall include:

 

(a)any Tax payable with respect to any business, asset, property or operation of
Acura or its Affiliates (including any Taxes relating to or arising out of the
Acquired Assets) for any Pre-Closing Tax Period, other than any Tax for which
MainPointe is responsible pursuant to Section 4.9 (“Excluded Tax Liability”);

 

(b)all accounts payable, accrued expenses and other current liabilities relating
to the Acquired Assets or the Nexafed Products to the extent arising before the
Effective Date, except to the extent assumed under the Transferred Contracts;
and

 

(c)all Liabilities arising out of or relating to any lawsuits, claims, actions
or proceedings relating to the manufacture, production, marketing,
commercialization, distribution or sale of the Products or the ownership, sale,
lease or use of any of the Acquired Assets to the extent the event,
circumstance, condition, action or inaction giving rise thereto occurs prior to
the Effective Date, provided that lawsuits, claims, actions or proceedings
related to infringement of Third Party intellectual property with respect to
Product manufactured by or for MainPointe or marketed, commercialized,
distributed, sold or leased by MainPointe shall not be an Excluded Liability and
shall be an Assumed Liability;

 

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Each of MainPointe's and Acura’s obligations under this Section 3.4 will not be
subject to offset or reduction by reason of any actual or alleged breach of any
representation, warranty, covenant or agreement contained in this Agreement or
any Other Transaction Document or any right or alleged right to indemnification
hereunder.

 

ARTICLE IV – PAYMENTS AND ROYALTIES

 

4.1         Payments. MainPointe shall make the following non-refundable,
non-creditable payments and provide the following notices, to Acura:

 

4.1.1           On the Effective Date, MainPointe shall pay Acura the sum of (A)
Two Million Five Hundred Thousand Dollars ($2,500,000) (the “Upfront License
Payment”) and (B) $425,020, representing the sum of (i) the cost of the
Transferred Inventory, plus (ii) Acura’s advance payment to Mikart, Inc.
relating to Purchase Order 1050 being assumed by MainPointe as a Transferred
Contract, plus (iii) the book value of equipment being transferred (the
“Acquisition Payment”).

 

4.1.2           MainPointe shall make the Option Territory Exercise Fee payments
as specified in Section 2.2.

 

4.1.3           MainPointe shall make the Option Product Exercise Fee payments
as specified in Section 2.3.

 

4.2         Royalties. The following payments shall be payable by MainPointe to
Acura for sales made during each calendar quarter and payment will be remitted
within forty-five (45) days after the end of the quarter to which it relates.

 

4.2.1           Royalty Payment. For each Product and for each country in the
Territory during the Royalty Term for such country, MainPointe shall pay to
Acura a royalty of Seven and One-Half Percent (7.5%) on all Net Sales of
Products in such country. Such royalty shall be payable for sales made during
each calendar quarter and payment will be remitted within forty-five (45) days
after the end of the quarter to which it relates. The royalty payment under this
section 4.2.1 is referred to as the “Royalty Payment.”

 

4.3         Royalty Reports. MainPointe shall prepare in respect of each
calendar quarter a report (“Royalty Report”) that shows for that calendar
quarter the Net Sales of Product by country and detailing the calculation of
Gross Sales and deductions from Gross Sales in arriving at Net Sales. MainPointe
shall submit such statement to Acura within forty-five (45) days of the end of
the calendar quarter to which it relates, together with its remittance for
Royalty Payments in respect of that quarter. The Royalty Report shall be in the
form of Exhibit E.

 

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4.4         Records. During the Term and for two (2) years thereafter, each
Party shall keep all usual and proper records and books of account and all usual
and proper entries relating to the Products. MainPointe shall maintain
(electronically or otherwise) such records and books of account containing all
necessary data for the calculation of Royalty Payments due under this Agreement.

 

4.5         Audits. MainPointe and its Affiliates and Sublicensees shall
maintain complete and accurate records in reasonably sufficient detail to permit
Acura to confirm the accuracy of the calculation of royalty payments. Upon
reasonable prior notice, such records shall be available during regular business
hours for a period of three (3) years from the end of the calendar year to which
they pertain for examination, not more often than once each calendar year, by an
independent certified public accountant selected by Acura and reasonably
acceptable to MainPointe, for the sole purpose of verifying the accuracy of the
financial reports furnished by MainPointe pursuant to this Agreement. Any such
auditor shall enter into a confidentiality agreement with MainPointe and shall
not disclose MainPointe's Confidential Information, except to the extent such
disclosure is necessary to verify the accuracy of the financial reports
furnished by MainPointe or the amount of payments due from MainPointe to Acura
under this Agreement. Any amounts shown to be owed but unpaid shall be paid, and
any amounts showed to be overpaid will be refunded, within forty-five (45) days
from the accountant's report. Acura shall bear the full cost of such audit
unless such audit discloses an underpayment to Acura of more than $10,000, in
which case MainPointe shall bear the full cost of such audit. Amounts shall be
deemed due on the original due date (e.g., when Royalty Payment was originally
due) and interest shall be applied as set forth in Section 4.8.

 

4.6         Pricing. MainPointe shall have sole discretion to determine the
price, terms and conditions of sales of Product(s) to MainPointe's customers.
MainPointe shall not price the Product in any country for any transaction as
part of a bundle that provides greater discounts for the Product as compared to
any other product in the bundle or otherwise disadvantage the selling price of
the Product in favor of its products. MainPointe will not allow any Product to
serve as a loss leader to induce the sale of other products.

 

4.7         Currency. All payments required under this Agreement shall be made
in U.S. dollars, regardless of the country(ies) in which sales are made or
expenses are incurred, via wire transfer of immediately available funds to an
account designated in writing by Acura. Whenever, for the purpose of calculating
any sums due under this Agreement, conversion from any foreign currency shall be
required, such conversion shall be made as follows: the amounts shall be
converted into United States dollars using the average rate of exchange for such
currencies for the relevant period, such exchange rate shall be the exchange
rate taken from The Wall Street Journal as published on the last day of the
relevant period for which payments are due, or such other publication as may be
agreed between the Parties from time to time.

 

4.8         Late Payments. All amounts payable under this Agreement and not paid
within thirty (30) days of when due in accordance with the provisions hereof
shall bear interest from the due date until paid at the rate equal to the lower
of (i) three percent (3%) over the prime rate of interest reported in the East
Coast Addition of The Wall Street Journal for the date such amount was due, per
annum and (ii) the maximum rate allowed by law. Unless otherwise stated all
dollar amounts in this Agreement are in United States dollars.

 

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4.9         Taxes.

 

4.9.1           In the event that a Party is mandated under the laws of a
country to withhold any tax to the tax or revenue authorities in such country in
connection with any payment to the other Party, such amount shall be deducted
from the payment to be made by such withholding Party, provided, however, that
the withholding Party shall take reasonable and lawful actions, at the other
Party’s sole cost, to avoid and minimize such withholding and promptly notify
the other Party so that the other Party may take lawful actions to avoid and
minimize such withholding. The withholding Party shall promptly furnish the
other Party with copies of any tax certificate or other documentation evidencing
such withholding as necessary to satisfy the requirements of the United States
Internal Revenue Service related to any application by such other Party for
foreign tax credit for such payment. Each Party agrees to cooperate with the
other Party in claiming exemptions from such deductions or withholdings under
any agreement or treaty from time to time in effect.

 

4.9.2           All Transfer Taxes and any filing or recording fees applicable
to the Acquisition shall be paid by MainPointe. Each Party shall use reasonable
efforts to avail itself of any available exemptions from any such Taxes or fees
and to cooperate with the other Party in providing any information and
documentation that may be necessary to obtain such exemptions.

 

4.9.3           The Acquisition Payment shall be allocated among the Acquired
Assets in accordance with Exhibit F. Such allocation is intended to comply with
the requirements of Section 1060 of the Code. Each of Acura and MainPointe
agrees that it shall (i) report the sale and purchase of the Acquired Assets for
United States Tax purposes in accordance with such allocations and (ii) not take
any position inconsistent with such allocations on any of their respective
United States Tax returns.

 

4.9.4           Acura shall be entitled to any refunds or credits of Taxes
relating to any Excluded Tax Liability. MainPointe shall be entitled to any
refunds or credits of Taxes relating to the Acquired Assets, other than any such
refunds or credits of Taxes relating to any Excluded Tax Liability.

 

4.9.5           Any value-added, goods and services, stamp duties, ad valorem
and similar Taxes shall be allocated between portions of a tax period that
includes (but does not end on) the Effective Date (a “Straddle Period”) in the
following manner: (i) in the case of a Tax imposed in respect of property and
that applies ratably to a Straddle Period, the amount of Tax allocable to a
portion of the Straddle Period shall be the total amount of such Tax for the
period in question multiplied by a fraction, the numerator of which is the total
number of days in such portion of such Straddle Period and the denominator of
which is the total number of days in such Straddle Period, and (ii) in the case
of sales, value added and similar transaction-based Taxes (other than Transfer
Taxes), such Taxes shall be allocated to the portion of the Straddle Period in
which the relevant transaction occurred.

 

4.9.6           For purposes of this Agreement, (i) “Tax” or “Taxes” shall mean
all United States federal, state, local and foreign taxes and similar
assessments (other than Transfer Taxes), including all interest, penalties and
additions imposed with respect to such amounts; (ii) “Pre-Closing Tax Period”
shall mean all taxable periods ending on or before the Effective Date and the
portion ending on the Effective Date of any taxable period that includes (but
does not end on) the Effective Date; (iii) “Post-Closing Tax Period” shall mean
all taxable periods beginning and ending after the Effective Date and the
portion beginning on the day after the Effective Date of any Straddle Period;
and (iv) “Code” shall mean the U.S. Internal Revenue Code of 1986, as amended.

 

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4.10       Nexafed Product Returns. Subject to this Section 4.10, MainPointe
shall be solely responsible for processing and handling all Product returns
occurring on or after the Effective Date. MainPointe will be responsible for the
credit liability associated with all returns of Product sold on or after the
Effective Date in the United States, and Acura will be responsible for the
credit liability for all returns of Product sold before the Effective Date. Lot
numbers of Product sold by Acura before the Effective Date are listed on
Schedule 4.10. Notwithstanding the foregoing, in the event Transferred Inventory
includes Products from lots that was sold by Acura prior to the Effective Date
(each referred to herein as a “Partial Lot”), MainPointe and Acura will each be
responsible for fifty percent (50%) of the credit liability associated with
returns of Product included in such Partial Lot (regardless of who sold such
Product). The issuance and determination of all credits and payments for any
returns for which Acura may have a credit liability hereunder (including with
respect to Partial Lots) shall be made in accordance with Acura’s returns policy
applicable to the Products as set forth in Schedule 4.10A, and the issuance and
determination of all credits and payments for any returns for which MainPointe
may have a credit liability hereunder shall be made in accordance with
MainPointe's returns policy applicable to the Products as provided to Acura in
writing as of the date hereof. If Acura receives returns it shall deliver to
MainPointe for processing as set forth above. MainPointe will destroy returned
Product in accordance with Applicable Laws. A Party may invoice the other Party
for the actual expenses incurred as a result of destroying Product for which the
other Party is responsible, including without limitation, fees paid to Third
Parties for receiving and processing such returned Product in accordance with
Applicable Laws. MainPointe will pay such invoice within thirty (30) days after
the date of the invoice for which it is responsible and with respect to a
payment for which Acura is responsible, MainPointe shall, as its sole method of
recovery on such invoice, deduct such amount from current and future Royalty
Payments due Acura for such invoiced amounts for which Acura is responsible.
MainPointe will issue a credit to the applicable Third Party in accordance with
the returns policy of the Party responsible for the credit liability and, if the
credit is issued by MainPointe for product for which Acura is responsible for
the credit liability with respect to such returned Product, MainPointe shall
invoice Acura for the amount of such credit and as its sole method of payment on
such invoice, deduct from current and future Royalty Payments due Acura for such
invoiced amounts for which Acura is responsible. The parties shall reconcile and
true up their accounting under this provision at the end of each calendar
quarter after the Effective Date until both Parties agree that such need no
longer exists. Each of MainPointe and Acura shall have the right during normal
business hours and on reasonable advance notice to review the other Party’s
books and records and consult with the other Party’s responsible employees in
respect of performance of this Section 4.10. MainPointe agrees that it will not
induce customers to accelerate, and it will not otherwise engage in any activity
(including through the granting of financial incentives or otherwise) the effect
of which would be the acceleration of, the return of Products sold by Acura or
any of its Affiliates to customers prior to the Effective Date.

 

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4.11       Change of NDC. MainPointe shall take any and all action necessary, as
expeditiously as possible (but in no event later than four (4) months after the
Effective Date), to change the NDC number for each Nexafed Product and to apply
such new NDC number to each Nexafed Product sold by MainPointe, provided, that
the foregoing shall not apply to the Transferred Inventory, as provided in
Section 9.5. For the avoidance of doubt, such actions shall include MainPointe
obtaining a new NDC number, if it does not already have one. MainPointe shall
communicate to the Centers for Medicare and Medicaid Services (“CMS”), with a
copy to Acura, the expiration dates for the last manufactured lots (“Last Lot
Expiration Dates”) of each of the Nexafed Products manufactured by or on behalf
of MainPointe that bears Acura’s NDC as soon as each such Last Lot Expiration
Date is available. Acura shall maintain with the FDA Acura’s NDC Number for each
Product as required for the manufacture and distribution of the Products until
the latest expiry of lots of Products included in the Transferred Inventory.

 

4.12       Retroactive Impact. In the event that any pricing change made by
MainPointe after the Effective Date has the effect of increasing any liability
or payment obligation owed by Acura to any Third Party to an amount greater than
the amount such liability or payment obligation would have been in the absence
of such pricing change, MainPointe shall reimburse Acura for such increase in
liability or payment obligation incurred by Acura.

 

4.13       Transition Services.

 

4.13.1         For the contracts listed on Schedule 4.13 (“Transition
Contracts”), which are not being assigned to MainPointe, Acura will forward
purchase orders to MainPointe and MainPointe will supply the Nexafed Products
(“Transition Products”) at the prices called for in such agreements and
otherwise abide by the terms of such agreements. Acura will forward to
MainPointe payments received on account of such sales and MainPointe will be
solely responsible for all returns (including any payments arising from such
returns).

 

4.13.2         MainPointe will also be responsible for any payments to the
counterparty (e.g., fees to wholesalers) arising from such sales. MainPointe
will indemnify and hold Acura harmless (including attorneys’ fees) for any
actions or inactions relating to such Products as if MainPointe was a party to
such non-assigned agreements, including without limitation, cover damages and
damages for late and non-delivery. Acura and MainPointe will coordinate the
termination of such agreements such that MainPointe can enter into agreements
directly with such customers without interrupting supply.

 

ARTICLE V – CONFIDENTIALITY AND LIMITATIONS ON USE

 

5.1         Confidentiality. Each Party agrees that, during the Term and for a
period of ten (10) years thereafter it shall keep confidential and shall not
publish or otherwise disclose and shall not use for any purpose other than as
provided for in this Agreement (which includes the exercise of any rights or the
performance of any obligations hereunder) any Confidential Information furnished
to it by the other Party pursuant to this Agreement, except to the extent
expressly authorized by this Agreement or otherwise agreed in writing by the
Parties. “Confidential Information” means information that the disclosing Party
considers confidential and discloses to the receiving Party for the purpose of
this Agreement. Confidential Information must be marked or otherwise identified
as confidential or proprietary or, under the circumstances surrounding the
disclosure, ought in good faith to be treated as confidential or proprietary.
Confidential Information may be conveyed in written, graphical, physical or oral
form. Confidential Information may include, without limitation, information
concerning the study, discovery, design, research, development, manufacture,
formulation, extraction, compounding, mixing, processing, testing, control,
preservation, storage, finishing, packing, packaging, use, administration,
distribution, sale, reimbursement and/or marketing of pharmaceutical products or
compounds and potential products or compounds, data from and methodology of
pre-clinical and clinical studies, the contents of any submissions to the U.S.
Food and Drug Administration (together with any successor agency), marketing
plans or computer hardware and software systems and designs and plans for same.
Confidential Information may include confidential or proprietary information of
a third party that is in the possession of a disclosing Party. The foregoing
confidentiality and non-use obligations shall not apply to any portion of the
other Party’s Confidential Information that the receiving Party can demonstrate
by competent written proof:

 

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(a)was already known to the receiving Party or its Affiliate, other than under
an obligation of confidentiality, at the time of disclosure by the other Party;

 

(b)was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the receiving Party;

 

(c)became generally available to the public or otherwise part of the public
domain after its disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement;

 

(d)was disclosed to the receiving Party or its Affiliate by a Third Party who
has a legal right to make such disclosure and who did not obtain such
information directly or indirectly from the other Party; or

 

(e)was independently discovered or developed by the receiving Party or its
Affiliate without access to or aid, application or use of the other Party’s
Confidential Information, as evidenced by a contemporaneous writing.

 

5.2         Authorized Disclosure. Notwithstanding the obligations set forth in
Section 5.1, a Party may disclose the other Party’s Confidential Information and
the terms of this Agreement to the extent:

 

(a)such disclosure is reasonably necessary to its employees, agents,
consultants, contractors, licensees or Sublicensees on a need-to-know basis for
the sole purpose of performing its obligations or exercising its rights under
this Agreement; provided that in each case, the disclosees are bound by written
obligations of confidentiality and non-use consistent with those contained in
this Agreement; or

 

(b)such disclosure is reasonably necessary to comply with Applicable Laws,
including regulations promulgated by the U.S. Securities and Exchange
Commission, applicable security exchanges, court order, administrative subpoena
or order; provided that the Party subject to such Applicable Laws shall promptly
notify the other Party of such required disclosure and shall use reasonable
efforts to obtain, or to assist the other Party in obtaining, a protective order
preventing or limiting the required disclosure.

 

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5.3         Publicity

 

(a)The Parties agree that the material terms of this Agreement are the
Confidential Information of both Parties, subject to the special authorized
disclosure provisions set forth in this Section 5.3 or Section 5.2. In addition,
a Party may disclose such terms to the extent reasonably necessary to be
disclosed to any bona fide potential or actual investor, lender, acquiror, or
merger partner for the sole purpose of evaluating an actual or potential
investment, acquisition or merger; provided that in connection with such
disclosure, such Party shall inform each disclosee of the confidential nature of
such Confidential Information and ensure that each such disclosee is
contractually obligated to treat such Confidential Information as confidential
on terms at least as restrictive as those contained in this Article 5.

 

(b)The Parties shall make a joint public announcement of the execution of this
Agreement in the form attached as Exhibit G, which shall be issued at a mutually
agreed time after the Effective Date.

 

(c)After release of such press release, if either Party desires to make a public
announcement concerning the material terms of this Agreement or any activities
hereunder, such Party shall give reasonable prior advance notice of the proposed
text of such announcement to the other Party for its prior review.

 

(d)The Parties acknowledge that either or both Parties may be obligated to file
under Applicable Laws a copy of this Agreement with the U.S. Securities and
Exchange Commission or other governmental authorities. Each Party may make such
a required filing, provided that it requests confidential treatment of the
commercial terms and sensitive technical terms hereof and thereof to the extent
such confidential treatment is reasonably available to such Party. In the event
of any such filing, each Party will provide the other Party with a copy of this
Agreement marked to show provisions for which such Party intends to seek
confidential treatment and shall reasonably consider and incorporate the other
Party’s reasonable comments thereon to the extent consistent with the legal
requirements, with respect to the filing Party, governing disclosure of material
agreements and material information that must be publicly filed.

 

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5.4         Prior Confidentiality Agreement. Nothing herein shall relieve any
Party of any breach of that certain Confidentiality Agreement, dated as of
November 11, 2016 (the “Prior Confidentiality Agreement”), by and between the
Parties with respect to the information disclosed between the Parties prior to
the date hereof, provided any information disclosed under such agreement shall
also be deemed disclosed under this Agreement and such agreement shall not apply
to any information disclosed after the date hereof, which disclosure shall be
governed by this Agreement.

 

ARTICLE VI – LIABILITY AND INDEMNIFICATION

 

6.1         Maximum Liability. Other than a Party’s indemnification obligations,
breach of the confidentiality provisions and non-compete provisions of Section
2.9, each Party’s maximum liability to the other Party for any claim arising
from this Agreement for any reason whatsoever (excluding monetary consideration
for this Agreement, such as Upfront Payments, Option territory Exercise Fees,
Option Product Exercise Fees, Royalty Payments, and out-of-pocket costs and
expenses) will not exceed the following payments made by MainPointe to Acura
during the twelve (12) month period preceding the date upon which the applicable
claim arose: the Upfront License Payment, Royalty Payments, Option Product
Exercise Fees and the Option Territory Exercise Fees.

 

6.2         Indemnification by Acura. Acura shall defend, indemnify, and hold
MainPointe and its Affiliates and their respective officers, directors and
employees (the “MainPointe Indemnitees”) harmless from and against any and all
damages, losses, liabilities costs or expenses (including reasonable attorneys’
fees) (“Losses”) incurred or sustained by such MainPointe Indemnitees resulting
from any claims, suits, proceedings or causes of action brought by a Third Party
(collectively, “Claims”) against such MainPointe Indemnitee to the extent
arising from or based on or arising from (a) Acura’s sales of Nexafed Products
prior to the date hereof (other than as provided in Section 8.7(b)); (b) Acura’s
breach of any of its obligations under this Agreement; (c) the gross negligence
or intentional misconduct of Acura; or (d) Acura’s breach of any representation
or warranty made or given in this Agreement, in each case except for any Claim
which arises from or is based on any activity set forth in Section 6.3 for which
MainPointe is obligated to indemnify the Acura Indemnitees under Section 6.3.

 

6.3         Indemnification by MainPointe. MainPointe shall defend, indemnify,
and hold Acura and its Affiliates and their respective officers, directors and
employees (the “Acura Indemnitees”) harmless from and against any and all Losses
incurred or sustained by such Acura Indemnitees resulting from any Claims
against such Acura Indemnitee brought by a Third Party to the extent arising
from or based on or arising from (a) MainPointe's breach of any of its
obligations under this Agreement; (b) any claims arising out of the
manufacturing or commercialization of Products (including, without limitation,
Transition Products) on or after the Effective Date; (c) the gross negligence or
intentional misconduct of MainPointe; (d) MainPointe's breach of any
representation or warranty made or given by MainPointe in this Agreement; (e) as
provided in Article 8; or (f) any actual or alleged infringement of any Third
Party copyright, trademark or trade dress rights arising from materials,
labeling, marketing or advertising of the Products, in each case except to the
extent any Claim arises from or is based on any activity set forth in Section
6.2 for which Acura is obligated to indemnify the MainPointe Indemnitees under
Section 6.2.

 

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6.4         Indemnification Procedures.

 

(a)The Party claiming indemnity under this Article VI (the “Indemnified Party”)
shall give written notice to the Party from whom indemnity is being sought (the
“Indemnifying Party”) promptly after learning of such Claim. The failure to give
such prompt written notice shall not, however, relieve the Indemnifying Party of
its indemnification obligations, except and only to the extent that the
Indemnifying Party forfeits rights or defenses by reason of such failure. The
Indemnifying Party shall have the right to participate in, or by giving written
notice to the Indemnified Party within 30 days of receipt of written notice of
the Claim, to assume the defense of any Claim at the Indemnifying Party’s
expense and by the Indemnifying Party’s own counsel, and the Indemnified Party
shall cooperate in good faith in such defense; provided, however, that the
Indemnifying Party’s right to assume the defense of any Claim shall be subject
to the Indemnifying Party acknowledging in writing to the Indemnified Party that
the Indemnifying Party is liable under this Article 6 to provide
indemnification. In the event that the Indemnifying Party assumes the defense of
any Claim, subject to Section 6.4(b), it shall have the right to take such
action as it deems necessary to avoid, dispute, defend, appeal or make
counterclaims pertaining to any such Claim in the name and on behalf of the
Indemnified Party; provided, that the Indemnified Party shall have the right, at
its own cost and expense, to participate in the defense of any such Claim with
counsel selected by it subject to the Indemnifying Party’s right to control the
defense thereof. If the Indemnifying Party elects not to compromise or defend
such Claim or fails to notify the Indemnified Party in writing of its election
to defend as provided in this Agreement, the Indemnified Party may, subject to
Section 6.4(b), pay, compromise, defend such Claim and seek indemnification for
any and all Losses based upon, arising from or relating to such Claim. Acura and
MainPointe shall cooperate with each other in all reasonable respects in
connection with the defense of any Claim for which indemnification is sought
under this Article 6, including making available (subject to the provisions of
Article 5) records relating to such Claim and furnishing, without expense (other
than reimbursement of actual out-of-pocket expenses) to the defending Party,
management employees of the non-defending Party as may be reasonably necessary
for the preparation of the defense of such Claim.

 

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(b)The Indemnifying Party shall not enter into settlement of any Claim without
the prior written consent of the Indemnified Party (which consent shall not be
unreasonably withheld or delayed), except as provided in this 6.4(b). If a firm
offer is made to settle a Claim without leading to liability or the creation of
a financial or other non-financial obligation on the part of the Indemnified
Party and provides, in customary form, for the unconditional release of each
Indemnified Party from all liabilities and obligations in connection with such
Claim (a “Qualified Settlement Offer”) and the Indemnifying Party desires to
accept and agree to such Qualified Settlement Offer, the Indemnifying Party
shall give written notice to that effect to the Indemnified Party. If the
Indemnified Party fails to consent to such Qualified Settlement Offer within ten
days after its receipt of such notice, the Indemnified Party may continue to
contest or defend such Claim and in such event, the maximum liability of the
Indemnifying Party as to such Claim shall not exceed the amount of such
settlement Qualified Settlement Offer. If the Indemnified Party fails to consent
to such Qualified Settlement Offer and also fails to assume defense of such
Claim, the Indemnifying Party may settle the Claim upon the terms set forth in
such Qualified Settlement Offer to settle such Claim. If the Indemnified Party
has assumed the defense pursuant to Section 6.4(b), it shall not agree to any
settlement without the written consent of the Indemnifying Party (which consent
shall not be unreasonably withheld or delayed).

 

(c)The procedures set forth in Section 8 shall supersede the provisions of this
Section 6.4, with respect to matters addressed therein.

 

6.5         Consequential Damages. Except for breaches of the confidentiality
provisions, and breach of the non-compete provision of Section 2.9, under no
circumstances whatsoever will either Party be liable to the other in contract,
tort, negligence, breach of statutory duty, or otherwise for (i) any (direct or
indirect) loss of profits, of production, of anticipated savings, of business,
or goodwill or (ii) for any other liability, damage, costs, or expense of any
kind incurred by the other Party of an indirect or consequential nature,
regardless of any notice of the possibility of these damages.

 

ARTICLE VII – NOTICES

 

7.1         Notices. Any notice or request to be given or furnished under this
Agreement by any Party to the other shall be in writing and shall be delivered
personally or registered or certified mail, postage prepaid, or by overnight
delivery service to the following:

 

TO ACURA: Acura Pharmaceuticals, Inc.   616 N. North Court   Palatine, IL 60067
  Attn:  Robert B. Jones   Telephone No. 847-705-7709     Copy To: LeClairRyan  
1037 Raymond Blvd.   Newark, NJ 07102   Attn:  John P. Reilly, Esq.   Telephone
No. 973-491-3354

 

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TO MainPointe:     MainPointe Pharmaceuticals, LLC   33 East Main St., Suite 220
  Louisville, KY 40202   Attn: John L. Schutte   Telephone No. 502-548-6276    
Copy To:                Frost Brown Todd Attorneys, LLC   400 West Market St.,
3200   Louisville, KY 40202   Attn: William G. Strench   Telephone No.
502-589-5400

 

7.2         Receipt of Notice. All notices and other communications given to any
Party in accordance with the provisions of this Agreement shall be deemed to
have been given on the date of receipt if delivered by hand or overnight courier
services or sent by telecopy, or on the date five (5) business days after
dispatch by certified or registered mail (postage prepaid) if mailed, in each
case delivered, sent or mailed (properly addressed) to such Party as provided in
this Article VII, or in accordance with the latest unrevoked direction from such
Party given in accordance with this Article VII.

 

7.3         Customer Notification. Promptly after the Effective Date, MainPointe
and Acura shall jointly prepare a written notice to Acura’s customers for the
Nexafed Products advising such customers (a) of the purchase by MainPointe of
the Nexafed Products and the Acquired Assets, (b) that all purchase orders for
Nexafed Products received by Acura prior to the Effective Date but not filled as
of such date have been transferred to MainPointe and (c) that all subsequent
purchase orders for Products should be sent to MainPointe or its designee, at
the following address: 333 East Main Street, Suite 220, Louisville, Kentucky
40202. Acura shall provide such notice to customers for the Nexafed Products
promptly following its completion by the Parties.

 

ARTICLE VIII – PATENT PROSECUTION, INFRINGEMENT

 

8.1         Ownership of Intellectual Property Rights. Acura shall own all
Intellectual Property Rights (including all Know-How and Patent Rights) in the
Impede® Technology, provided that if MainPointe makes any improvements to the
Impede Technology, then MainPointe shall own such improvements provided that it
shall inform Acura of such improvements, and hereby grants Acura a royalty-free,
perpetual, sublicensable, non-exclusive license to such improvements to develop,
manufacture and commercialize products other than the Products. MainPointe owns
all trademarks and goodwill associated with the marketing and commercialization
of the Nexafed Products in the Territory, with the exception of any mark
incorporating Acura’s corporate name, Impede® and Nexafed®, or any marks
incorporating Impede® and Nexafed®, which shall be owned by Acura.

 

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8.2         Patent Prosecution and Maintenance. Acura is responsible for the
prosecution and maintenance of the Impede® Patent Rights in its sole discretion
and at its own cost and expense, provided that any fees and expenses for
maintenance or prosecution and maintenance outside the United States shall be at
MainPointe's expense. Acura shall provide MainPointe a reasonable opportunity to
review and comment on such prosecution and maintenance efforts regarding Impede®
Patent Rights in the Territory that may claim the Products, or the making or the
use thereof. Acura shall provide MainPointe with a copy of material
communications from any patent authority in the Territory regarding such Impede®
Patent Rights within a reasonable time after receipt of such communications and
shall provide drafts of any material filings or responses to be made to such
patent authorities in a reasonable amount of time in advance of submitting such
filings or responses for MainPointe's review and comment. Acura shall reasonably
consider such comments by MainPointe in connection with the prosecution and
maintenance of the Impede® Patent Rights. If Acura decides to cease the
prosecution or maintenance of any Impede® Patent Rights that claim the
Product(s), after it has commenced prosecution of such Impede Patent Rights in
the Territory, and Bayer has not exercised such rights under the Bayer
Agreement, Acura shall notify MainPointe in writing so that MainPointe may, at
its discretion, assume the responsibility for the prosecution or maintenance of
such Impede® Patent Rights in the Territory, provided Acura shall own all such
resulting patents.

 

8.3         Infringement of Impede® Patent Rights. Each of MainPointe and Acura
will notify the other Party within five (5) days upon learning of any possible
infringement by a Third Party of the Impede® Patent Rights, which infringement
may reasonably be expected to affect the commercialization of a Product.
MainPointe has the exclusive right (after consultation with Acura), but not the
obligation, at MainPointe's own cost, to take all steps, including legal action,
it deems necessary or advisable to eliminate or minimize the effect on the
development, manufacture and commercialization of the Products of such possible
infringement. Acura agrees to cooperate, upon reasonable request of MainPointe
and at MainPointe's cost, in such steps or legal proceeding. All proceeds
realized upon any judgement or settlement in MainPointe's favor regarding such
steps or legal action, net of direct out-of-pocket expenses of the Parties
relating thereto, shall be for the benefit of MainPointe provided MainPointe
shall pay Acura the same royalty on the excess as it is required to pay on Net
Sales. Notwithstanding the foregoing, Acura’s consent (which shall not be
unreasonably withheld, delayed or conditioned) shall be required for any
settlement that entails any license or covenant not to sue, relating to the
Impede® Patent Rights, or dedication to the public, admission of invalidity or
unenforceability, or abandonment of any Impede® Patent Rights.

 

8.4         Notice by MainPointe of Intent to Assert; Acura’s Right to Assert.

 

(a)No later than five (5) business days after learning or being notified of any
possible infringement by a Third Party of the Impede® Patent Rights, which
infringement may reasonably be expected to affect the commercialization of a
Product, MainPointe shall provide written notice to Acura as to whether
MainPointe will exercise its rights conferred in Section 8.3.

 

(b)If MainPointe does not provide Acura with such written notice within twenty
(20) business days or within such time provides notice to Acura electing not to
exercise its rights conferred in Section 8.3, then at any time Acura may, but
shall not be obligated, to provide MainPointe written notice as to whether Acura
will take steps to eliminate or minimize the consequences of such possible
infringement to the commercialization of the Products.

 

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(c)If Acura elects, pursuant to Section 8.4(b), to take steps to eliminate or
minimize the consequences of such possible infringement to the commercialization
of a Product, the following shall apply: Acura shall have the exclusive right,
at Acura’s own cost and expense, to take such steps as it shall determine,
including legal action, to eliminate or minimize the consequences of such
possible infringement to the commercialization of the Product. Acura shall be
entitled to any judgement or settlement relating to such action. MainPointe
agrees to join as a named party and cooperate, upon reasonable request of Acura
and at Acura’s cost and expense, in any such steps or legal proceeding.

 

8.5         Third Party Challenges to Impede® Patent Rights. Notwithstanding
Section 8.3, each of MainPointe and Acura shall notify the other Party no later
than five (5) business days after receiving a Paragraph IV Certification, an
Inter Parties or Post Grant review petition, or any other challenge that an
Impede® Patent Right is invalid or unenforceable, if such Impede® Patent Right
claims the Product, or the manufacture, or use thereof. MainPointe has the right
(after consultation with Acura), but not the obligation, at MainPointe's own
cost, to exclusively pursue any negotiations with such Third Party and
exclusively control the enforcement or defense of any legal proceeding regarding
such challenge. Acura agrees to cooperate, upon reasonable request of MainPointe
and at MainPointe's cost, in such negotiations or legal proceeding. All proceeds
realized upon any judgement or settlement in MainPointe's favor regarding such
negotiations or legal proceeding, net of direct out-of-pocket expenses of the
Parties relating thereto, shall be for the benefit of MainPointe, provided
MainPointe shall pay Acura the same royalty on the excess as it is required to
pay on Net Sales. Notwithstanding the foregoing, Acura’s consent (which shall
not be unreasonably withheld, delayed or conditioned) shall be required for any
settlement that entails any license or covenant not to sue, relating to the
Impede® Patent Rights, or dedication to the public, admission of invalidity or
unenforceability, or abandonment of the Impede® Patent Rights.

 

8.6         Notice by MainPointe to Defend; Acura’s Right to Defend.

 

(a)Notwithstanding Section 8.4, no later than five (5) business days after
MainPointe learns of a Paragraph IV Certification, an Inter Parties or Post
Grant review petition, or any other challenge that an Impede® Patent Right is
invalid or unenforceable, which Impede® Patent Right claims a Product, or the
manufacture, or use thereof, MainPointe shall provide written notice to Acura as
to whether MainPointe will exercise its rights conferred in Section 8.5.

 

(b)If MainPointe does not provide Acura with such written notice within its ten
(10) business day period of Section 8.6(a) or within such time provided notice
to Acura electing not to exercise its rights conferred in Section 8.5, then
Acura may at its option, but shall not be obligated to, notify MainPointe in
writing at any time thereafter whether Acura will undertake the enforcement or
defense of any legal proceeding.

 

 26 

 

 

 

(c)If Acura undertakes such defense or enforcement pursuant to Section 8.6(b),
the following paragraph shall apply: Acura shall be entitled, at Acura’s own
cost and expense, to exclusively pursue any negotiations with such Third Party
and exclusively control the enforcement or defense of any legal proceeding
regarding such challenge. If Acura undertakes the defense or enforcement, Acura
shall be entitled to any judgement or settlement relating to such action.
MainPointe agrees to join as a named party and cooperate, upon reasonable
request of Acura and at MainPointe's cost and expense, in any such steps or
legal proceeding. Notwithstanding the foregoing, MainPointe's consent (which
shall not be unreasonably withheld, delayed or conditioned) shall be required
for any settlement that would limit or restrict MainPointe's rights conferred by
this Agreement.

 

8.7         Allegations of Infringement by Third Parties.

 

(a)Each of MainPointe and Acura will forthwith notify the other Party upon
learning of any allegation by a Third Party that (i) a Product may infringe
Third Party intellectual property rights, or (ii) any product that includes the
Impede® Technology other than a Product (a “Related Impede® Technology Product”)
may infringe Third Party intellectual property rights and the Parties shall in
that event consult with each other, including a possible defense strategy.

 

(b)If the infringement allegation against a Product is due to the Impede®
Technology, MainPointe has the obligation to pursue any negotiations with the
claimant and to control the defense of any legal proceeding regarding such
infringement allegation against the Product at its own cost and expense
(including the cost of defense, judgments, damages and settlements) and shall
indemnify and hold Acura harmless from same. Acura shall, at MainPointe's
expense, reasonably collaborate with MainPointe and render any reasonable
assistance to MainPointe in MainPointe's negotiations with the claimant and
defense of any such legal proceeding regarding such allegation of infringement.

 

(c)If the infringement allegation is against a Related Impede® Technology
Product, Acura reserves the limited right to negotiate with the claimant solely
in its own name and on its own behalf relating to the Related Impede® Technology
Product and defend only itself in any legal proceeding regarding such allegation
of infringement as it may relate to the Related Impede® Technology Product at
its own cost and expense (including the cost of defense, judgments, damages, and
settlements). MainPointe shall, at MainPointe's expense, reasonably collaborate
with Acura and render any reasonable assistance to Acura in Acura’s negotiations
with the claimant and Acura’s defense of any legal proceeding regarding such
allegation of infringement as it may relate to the Related Impede® Technology
Product. If Acura elects to undertake negotiation or defense pursuant to this
section, Acura is neither authorized nor obligated to negotiate on behalf of or
defend MainPointe.

 

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8.8         Settlement of Allegations of Infringement. For purposes of Sections
8.7 and 8.8, the Party negotiating with the claimant or defending the legal
proceeding is referred to as the “Defending Party” and the other Party is
referred to as the “non-Defending Party.” The Defending Party shall have the
right to exclusively control and manage such claim of infringement (including
without limitation, control over the settlement of such action), provided,
however, that any such settlement shall also release the non-Defending Party
from the claims relating to the claim of infringement (provided that the
non-Defending Party executes a mutual release in favor of the party releasing
the non-Defending Party). The written consent of the non-Defending Party to the
settlement is required if the settlement obligates the non-Defending Party to
take or forgo any action (which consent shall not be unreasonably withheld,
delayed or conditioned). Without limiting the foregoing, Acura’s consent (which
shall not be unreasonably withheld, delayed or conditioned) shall be required
for any settlement that entails any license, covenant not to sue relating to,
dedication to the public, admission of noninfringement, invalidity or
unenforceability or abandonment of Acura’s Intellectual Property Rights,
including without limitation the Impede® Technology, and MainPointe's consent
(which shall not be unreasonably withheld, delayed or conditioned) shall be
required for any settlement that that would limit or restrict the ability of
MainPointe to have made, use, offer for sale, sell or otherwise commercialize
Product(s) in the Field in the Territory

 

ARTICLE IX – REPRESENTATIONS, WARRANTIES AND COVENANTS

 

9.1         Cooperation.

 

9.1.1           MainPointe and Acura shall cooperate with each other, and shall
cause their respective officers, employees, agents, auditors and representatives
to cooperate with each other, for a period of one hundred twenty (120) days
after the Effective Date to ensure the orderly transition of the Products and
the Acquired Assets from Acura to MainPointe and to minimize any disruption to
the respective businesses of Acura, APT and MainPointe that might result from
the transactions contemplated hereby. After the Effective Date, upon reasonable
written notice, MainPointe and Acura shall furnish or cause to be furnished to
each other and their employees, counsel, auditors and representatives reasonable
access, during normal business hours, to such information and assistance
relating to the Products and the Acquired Assets as is reasonably necessary for
financial reporting and accounting matters, the preparation and filing of any
Tax returns, reports or forms or the defense of any Tax claim or assessment. The
obligation to cooperate pursuant to the preceding sentence insofar as it
concerns Taxes shall terminate at the time the relevant applicable statute of
limitations expires (giving effect to any extension thereof). Each party shall
reimburse the other for reasonable out-of-pocket costs and expenses incurred in
assisting the other pursuant to this Section 9.1. Neither party shall be
required by this Section 9.1 to take any action that would unreasonably
interfere with the conduct of its business or unreasonably disrupt its normal
operations.

 

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9.1.2           From time to time, as and when requested by either party hereto,
the other party shall execute and deliver, or cause to be executed and
delivered, all such documents and instruments and shall take, or cause to be
taken, all such further or other actions, as such other Party may reasonably
deem necessary or desirable to consummate the transactions contemplated by this
Agreement.

 

9.2         Mutual Representations, Warranties and covenants. Each Party
represents and warrants that

 

(i)it has the full right, power and authority to enter into this Agreement;

 

(ii)that entering into and performing its obligations set forth in this
Agreement does not conflict with any other agreement to which it is a party;

 

(iii)as at the Effective Date, there are no claims, judgments, litigations,
suits, actions, disputes, arbitration, judicial or legal, administrative or
other proceedings or governmental investigations pending or, to such Party’s
knowledge, threatened against such Party or any of its Affiliates, and neither
such Party nor its Affiliates is a party to any settlement agreement, which
would be reasonably expected to materially affect or restrict the ability of
such Party to consummate the transactions contemplated under this Agreement and
to perform its obligations under this Agreement; and

 

(iv)neither Party has used or shall use any employee or consultant who has been
debarred by any Regulatory Authority or, to such Party’s knowledge, is or has
been the subject of debarment proceedings by a Regulatory Authority. Each Party
shall notify the other Party promptly upon becoming aware that any of its
employees or consultants has been debarred or is the subject of debarment
proceedings by any Regulatory Authority.

 

9.3         Acura Representations, Warranties. Acura represents and warrants
that: (i) it has all rights necessary to validly grant the licenses set forth in
Section 2; (ii) the Patent Rights included in the Impede® Technology and set
forth on Exhibit D have not expired and any maintenance fees have been paid when
due or within any permitted extension; (iii) it is not subject to any court
proceedings, judgment or order related to the subject matter of this Agreement;
(iv) it has not received any written claim or allegation of infringement from a
Third Party for the infringement of Third Party intellectual property rights
based on the making, using, or selling of the Currently Marketed Nexafed
Products (other than for a claim related to the use of the Nexafed trademark
that has been resolved); (v) it has not assigned and/or granted licenses, nor
shall it assign and/or grant licenses, to the Impede® Technology to any Third
Party that would restrict or impair the rights granted hereunder, and it has not
granted to anyone any rights that cover Nexafed Products in the Territory; (vi)
the Impede Patent Rights are the only Patents Right Controlled by Acura relating
to the Nexafed Products and any products referred to as Nexafed 2.0 which have
been developed by Acura; and (vii) to its actual knowledge the Impede®
Technology (a) does not infringe any valid claim in a granted patent known to
Acura as of the Effective Date owned by a Third Party and (b) has not been
misappropriated from a Third Party.

 

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9.4         MainPointe’s Representations Warranties and Covenants. MainPointe
represents, warrants and covenants that (i) it shall develop, manufacture and
commercialize the Products in accordance with Applicable Law and (ii) neither
MainPointe nor its Affiliates shall engage in a Patent Challenge, or knowingly
assist any Third Party to engage in a Patent Challenge with respect to any of
the Impede® Patent Rights or intentionally or willfully infringe the Impede
Patent Rights.

 

9.5         No Use of Certain Names; Transitional License. MainPointe shall
promptly, and in any event within ninety (90) days after Effective Date,
(a) revise any and all product literature and labeling and Transferred
Advertising Material to delete all references to the Acura Names and (b) delete
all references to Acura or APT’s customer service address or telephone number;
provided, however, that for a period of one hundred eighty (180) days from the
Effective Date MainPointe may continue to distribute such product literature and
Transferred Advertising Material that uses any Acura Names, addresses or
telephone numbers to the extent that such product literature and Transferred
Advertising Material exists on the date hereof, and, only to the extent
necessary to allow MainPointe to distribute such product literature and
Transferred Advertising Material during such one hundred eighty (180) day
period, Acura hereby grants to MainPointe the limited right, on a royalty-free
basis, to use the Acura Name and Acura’s trade dress, copyrights and other
intellectual property owned by Acura and appearing in such product literature
and Transferred Advertising Material on the date hereof. In no event shall
MainPointe use any Acura Names or Acura’s addresses, telephone numbers, trade
dress, copyrights or other intellectual property after the Effective Date in any
manner or for any purpose different from the use of such Acura Name or Acura’s
addresses, telephone numbers, trade dress, copyrights or other intellectual
property by Acura or APT with respect to the Nexafed Products prior to the
Effective Date. With respect to the Transferred Inventory, MainPointe shall be
entitled to continue to use the Acura Name and Acura’s NDC Number for each of
the Nexafed Products until such time as the Transferred Inventory is exhausted,
provided, however, that notwithstanding the foregoing, in the event MainPointe
encounters difficulties in obtaining a new NDC Number for a Product or in
obtaining FDA approval for changes to the labeling for a Nexafed Product which
deletes all references to the Acura Name, Acura shall provide MainPointe with
such reasonable extensions to the time period in which MainPointe may use the
Acura Name and Acura’s NDC Number as may be requested by MainPointe to Acura in
writing. “Acura Name” means (i) “Acura”, “Acura Pharmaceuticals”, “Acura
Pharmaceuticals, Inc,”, “Acura Pharmaceutical Technologies”, and “Acura
Pharmaceutical technologies, Inc.”, any variations and derivatives thereof.

 

9.6         Disclaimers. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO
REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY
RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS
AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY
EXPRESSLY EXCLUDED.

 

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ARTICLE X – TERM AND TERMINATION

 

10.1       Term and Expiration. The “Term” of this Agreement shall be from the
Effective Date until the earlier of (i) termination of this Agreement pursuant
to Section 10.2 or 10.3 or (ii) the last to expire Royalty Term.

 

10.2       Termination for Breach.

 

Either Party may terminate the Agreement in its entirety by giving written
notice of termination at any time, if the other Party fails to fulfill or
breaches any material term or condition of this Agreement, and does not remedy
the failure or breach within thirty (30) days of receipt of written notice
specifying such failure or breach given by the other Party.

 

10.3       Termination for Patent Challenge.

 

Acura will be permitted to terminate this Agreement by written notice effective
upon receipt if MainPointe or its Affiliates, directly or indirectly through
assistance granted to a Third Party, commence any interference or opposition
proceeding, challenge in a legal or administrative proceeding the validity or
enforceability of, or oppose in a legal or administrative proceeding any
extension of or the grant of a supplementary protection certificate with respect
to (i) any Patent Rights licensed hereunder (except as a defense against a
patent infringement action initiated by Acura or its Affiliates or licensees
against MainPointe or its Affiliates) (each such action, a “Patent Challenge”).

 

MainPointe will include provisions in all agreements granting sublicenses of
MainPointe's rights hereunder (other than agreements with manufacturers,
services providers, distributors and other agents) providing that if the
sublicensee or its Affiliates undertake a Patent Challenge with respect to any
Patent Rights licensed hereunder under which the sublicensee is sublicensed,
MainPointe will be permitted to terminate such sublicense agreement. If a
sublicensee of MainPointe (or an Affiliate of such sublicensee) undertakes a
Patent Challenge of any such Patent Right under which such sublicensee is
sublicensed (other than sublicensees that are manufacturers, services providers,
distributors and other agents), then MainPointe upon receipt of notice from
Acura of such Patent Challenge will terminate the applicable sublicense
agreement. If MainPointe fails to so terminate such sublicense agreement, Acura
may terminate MainPointe's right to sublicense in the country(ies) covered by
such sublicense agreement and any sublicenses previously granted in such
country(ies) shall automatically terminate. In connection with such sublicense
termination, MainPointe shall cooperate with Acura’s reasonable requests to
cause such a terminated sublicensee to discontinue activities with respect to a
Product in such country(ies).

 

10.4       Consequences of Expiration and Termination.

 

10.4.1           Upon expiration of this Agreement with respect to a country,
MainPointe shall retain a non-exclusive, perpetual, irrevocable, fully paid-up
and royalty-free license to, develop, have made, sell, promote, or otherwise
exploit the Product in such country.

 

10.4.2           Upon termination of this Agreement: (i) all of MainPointe's
licenses with respect to Acura’s trademarks and the Impede® Technology shall
terminate; (ii) MainPointe's non-compete contained in Section 2.9 shall
terminate immediately; and (iii) at Acura’s request MainPointe and Acura shall
use commercially reasonable efforts to transition the commercialization of
Nexafed Products back to Acura so that, among other things, sales of Nexafed
Products are not interrupted and which may include, by way of example,
assignment of Product manufacturing and supply agreements to Acura or its
designee.

 

 31 

 

 

Termination, relinquishment or expiration of this Agreement for any reason shall
be without prejudice to any rights that shall have accrued to the benefit of
either Party prior to such termination, relinquishment or expiration. Such
termination, relinquishment or expiration shall not relieve either Party from
obligations that are expressly indicated to survive termination or expiration of
this Agreement.

 

10.4.3           All of the Parties’ rights and obligations under Sections 2.6,
2.7, 2.8.2, 2.10, 2.13, 3.3, 3.4, 4.2, 4.4, 4.5, 4.7, 4.8, 4.9, 4.10, 4.11,
4.12, 4.13.2 and Articles 5, 6, 7, 8, 10 and 11, shall survive termination or
expiration of this Agreement (unless such Section specifically states that it
shall only survive expiration but not termination, in which case it shall
survive as set forth therein), and all other provisions reasonably construed to
survive shall also survive termination or expiration. Where a provision
specifies a survival period, such provision shall survive only during such
survival period.

 

ARTICLE XI – MISCELLANEOUS

 

11.1       Dispute Resolution. MainPointe and Acura agree to use good faith
efforts to resolve any and all disputes arising out of or relating to this
Agreement. If after forty five (45) days following receipt of notice by one
Party from the other of a dispute under this Agreement, the Parties are unable
to resolve the dispute, then the matter shall by fully and finally resolved by
arbitration. A Party that desires to arbitrate a dispute shall serve a written
notice upon another requesting arbitration of a dispute pursuant to this Section
11.1. Any such arbitration shall be submitted to final and binding arbitration
under the then current commercial arbitration rules of the American Arbitration
Association (the “AAA”) in accordance with this Section 11.1. The place of
arbitration of any dispute shall be New York, New York. Such arbitration shall
be conducted by one (1) arbitrator mutually agreed by the Parties but if such
agreement cannot be reached within ten (10) days of the commencement of the
arbitration, then an arbitrator appointed by the AAA. The arbitrator shall be a
person with relevant experience in the pharmaceutical industry. The arbitration
proceeding shall be held as soon as practicable but in any event within ninety
(90) days of appointment of the arbitrator. Any award rendered by the
arbitrators shall be final and binding upon the Parties. Judgment upon any award
rendered may be entered in any court having jurisdiction, or application may be
made to such court for a judicial acceptance of the award and an order of
enforcement, as the case may be. The arbitrator shall render a formal, binding,
non-appealable resolution and award as expeditiously as possible, but not more
than forty-five (45) days after the hearing. Each Party shall pay its own
expenses of arbitration, and the expenses of the arbitrator shall be equally
shared between the Parties unless the arbitrators assess as part of their award
all or any part of the arbitration expenses of a Party (including reasonable
attorneys’ fees) against the other Party. A Party may make application to the
Arbitrator for the award and recovery of its fees and expenses (including
reasonable attorneys’ fees). This Section 10.1 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by any other Party which would
cause irreparable harm to the first Party.

 

 32 

 

 

11.2       Rights in Bankruptcy.

 

11.2.1           All rights and licenses granted under or pursuant to this
Agreement by one Party to the other are, for all purposes of Title 11 of the
United States Code (“Title 11”), licenses of rights to “intellectual property”
as defined in Title 11, and, in the event that a case under Title 11 is
commenced by or against either Party (the “Bankrupt Party”), the other Party
shall have all of the rights set forth in Section 365(n) of Title 11 to the
maximum extent permitted thereby. During the Term, each Party shall create and
maintain current copies to the extent practicable of all such intellectual
property. Without limiting the Parties’ rights under Section 365(n) of Title 11,
if a case under Title 11 is commenced by or against the Bankrupt Party, the
other Party shall be entitled to a copy of any and all such intellectual
property and all embodiments of such intellectual property, and the same, if not
in the possession of such other Party, shall be promptly delivered to it (i)
before this Agreement is rejected by or on behalf of the Bankrupt Party, within
thirty (30) days after the other Party’s written request, unless the Bankrupt
Party, or its trustee or receiver, elects within thirty (30) days to continue to
perform all of its obligations under this Agreement, or (ii) after any rejection
of this Agreement by or on behalf of the Bankrupt Party, if not previously
delivered as provided under clause (i) above. All rights of the Parties under
this Section 11.2 and under Section 365(n) of Title 11 are in addition to and
not in substitution of any and all other rights, powers, and remedies that each
party may have under this Agreement, Title 11, and any other Applicable Laws.
The non-Bankrupt Party may perform the obligations of the Bankrupt Party
hereunder with respect to such intellectual property, but neither such provision
nor such performance by the non-Bankrupt Party shall release the Bankrupt Party
from any such obligation or liability for failing to perform it.

 

(b)        The Parties agree that they intend the foregoing non-Bankrupt Party
rights to extend to the maximum extent permitted by law and any provisions of
applicable contracts with Third Parties, including for purposes of Title 11, (i)
the right of access to any intellectual property (including all embodiments
thereof) of the Bankrupt Party or any Third Party with whom the Bankrupt Party
contracts to perform an obligation of the Bankrupt Party under this Agreement,
and, in the case of the Third Party, which is necessary for the development,
Regulatory Approval and manufacture of Products and (ii) the right to contract
directly with any Third Party described in (i) in this sentence to complete the
contracted work.

 

(c)        Any intellectual property provided pursuant to the provisions of this
Section 11.2 shall be subject to the licenses set forth elsewhere in this
Agreement and the payment obligations of this Agreement, which shall be deemed
to be royalties for purposes of Title 11.

 

11.3       No Set-off. Except as expressly set forth in this Agreement, neither
Party may set-off or recoup against a payment owed to the other Party, without
the consent of the other Party.

 

11.4       Waivers; Amendment. The failure of either Party to insist, in any one
or more instances, upon the performance of any of the terms, covenants or
conditions of this Agreement or to exercise any right hereunder, shall not be
construed as a waiver or relinquishment of the future performance of any such
term, covenant or conditions or the future exercise of such right, and the
obligation of the other Party with respect to such future performance shall
continue in full force and effect. No item or provision of this Agreement may be
altered, amended or waived except by a writing signed by both Parties.

 

 33 

 

 

11.5       Assignment. Neither Party shall assign any of its rights or
obligations under this Agreement, in whole or in part to any person, firm,
partnership, or other entity, except to an Affiliate, without the prior written
consent of the other Party, which consent shall not be unreasonably withheld,
delayed or conditioned. Notwithstanding the foregoing, a Party may assign this
Agreement in connection with (i) the transfer of all or substantially all of its
assets or its Impede Technology assets (by merger, sale of assets or otherwise)
to the transferee thereof or (ii) the sale of its line of business to which this
Agreement relates; provided in each instance the transferee agrees to be bound
by all obligations of the transferring Party to the other Party hereunder.

 

11.6       Covenant of Further Assurances. MainPointe and Acura covenant and
agree that subsequent to the execution and delivery of this Agreement and
without any additional consideration, each of MainPointe and Acura shall execute
and deliver any further legal instruments and perform such acts which are or may
become necessary to effectuate the purposes of this Agreement.

 

11.7       Headings. The heading of the Articles and Sections used in this
Agreement are included for convenience only and are not to be used in construing
or interpreting this Agreement.

 

11.8       Governing Law. Unless any competent governmental entity or any other
applicable laws and regulations require otherwise, this Agreement shall be
governed by and construed under the laws of the State of New York as applied to
agreements executed and performed solely in New York, without regard to
choice-of-law principles thereof.

 

11.9       Severability. The provisions of this Agreement shall be deemed
separate. Accordingly, the invalidity or unenforceability of any particular
provision of this Agreement shall not affect the other provisions, and this
Agreement shall be construed in all respects as if such invalid or unenforceable
provision were omitted, except in cases where such unenforceable provision is a
basic prerequisite of any Party or both Parties to enter into this Agreement.
The Parties shall in such an instance use their best efforts to replace the
unenforceable provision(s) with valid, legal and enforceable provision(s) which,
insofar as practical, implement the purposes of this Agreement.

 

11.10     Entire Agreement. This Agreement including all Exhibits and Schedules
attached hereto constitutes the entire Agreement between MainPointe and Acura
with respect to the subject matter addressed herein and this Agreement
supersedes all prior understandings and agreements, whether oral or written,
between the MainPointe and Acura with respect thereto, except the Prior
Confidentiality Agreement to the extent set forth in Section 5.4. Any amendment
to any provisions set forth in the Agreement must be in writing, signed by both
MainPointe and Acura and specifically state that it is an amendment.

 

11.11     Counterparts; Facsimile Signatures. This Agreement may be executed in
multiple counterparts, each of which shall be deemed to be an original and of
equal force and effect, but all of which taken together shall constitute one and
the same instrument. A facsimile, digital, PDF, e-mail or other electronic copy
hereof shall suffice as an original Agreement.

 

11.12     Waiver of Rule of Construction. Each Party has had the opportunity to
consult with counsel in connection with the review, drafting and negotiation of
this Agreement. Accordingly, the rule of construction that any ambiguity in this
Agreement shall be construed against the drafting Party shall not apply.

 

 34 

 

 

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

 

ACURA PHARMACEUTICALS, INC.   MAINPOINTE PHARMACEUTICALS, LLC           By: /s/
Robert B. Jones   By: /s/ Douglas Morris           Name: President & CEO   Name:
Douglas E. Morris           Title: Robert B. Jones   Title: Secretary/Treasurer
          Date: 14 March 2017   Date: 3/16/17

 

 35 

 

 

Exhibit A

Assignment of Contracts (General)

 

ASSIGNMENT OF CONTRACT RIGHTS

 

For good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, Acura Pharmaceuticals, Inc., with offices at 616 N. North
Court, Palatine IL 60067 (“Seller”), does hereby assign, grant, bargain,
transfer, sell, convey and deliver to Mainpointe Pharmaceuticals, LLC, a
Kentucky limited liability company, with offices at 333 East Main Street, Suite
220, Louisville, Kentucky 40202 (“Buyer”), Seller’s rights under the Transferred
Contracts, as such term is defined in the License, Commercialization and Option
Agreement by and among Buyer and Seller (the “Agreement”), to the extent set
forth in the Agreement. Seller for itself, its successors and assigns hereby
covenants and agrees that, at any time and from time to time forthwith upon the
written request of Buyer, Seller will do, execute, acknowledge and deliver or
cause to be done, executed, acknowledged and delivered, each and all of such
further acts, deeds, assignments, transfers, conveyances, powers of attorney and
assurances as may reasonably be required by Buyer in order to assign, transfer,
set over, convey, assure and confirm unto and vest in Buyer, its successors and
assigns, all of the rights of Seller under the Transferred Contracts.

 

Buyer’s assumption of liabilities under the Transferred Contracts is governed by
a separate instrument entitled “Assumption of Liabilities,” and is subject to
all of the qualifications and conditions stated in such instrument and in the
Agreement.

 

his Assignment of Contract Rights is being executed and delivered by Seller as
of the date set forth below pursuant to the terms of the Agreement.

 

Dated this ____ day of March, 2017

 

  SELLER:       ACURA PHARMACEUTICALS, INC.

 

  By:       Name:     Title:

 

BUYER:

 

Mainpointe Pharmaceuticals, LLC

 

By:       Name:     Title:  

 

 36 

 

 

Exhibit B

Assumption Agreement

 

ASSUMPTION OF LIABILITIES

 

Pursuant to that certain License, Commercialization and Option Agreement
(the “Agreement”) by and among by and between Mainpointe Pharmaceuticals, LLC, a
Kentucky limited liability company, with offices at 333 East Main Street, Suite
220, Louisville, Kentucky 40202 (“Buyer”), and Acura Pharmaceuticals, Inc., with
offices at 616 N. North Court, Palatine IL 60067 (“Seller”), for good and
valuable consideration, the receipt and adequacy of which are hereby
acknowledged, Buyer hereby does assume the Assumed Liabilities (including all
liabilities of Acura under or otherwise relating to the assigned contracts to
the extent the event, circumstance, condition, action or inaction giving thereto
occurs on or after the date hereof) as such term is defined in the Agreement by
and subject to the terms and conditions of the Agreement.

 

Dated this ____ day of March, 2017

 

  BUYER:       MAINPOINTE PHARMACEUTICALS, LLC

 

  By:       Name:     Title:

 

 37 

 

 

Exhibit C

Bill of Sale

 

For good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, Acura Pharmaceuticals, Inc., with offices at 616 N. North
Court, Palatine IL 60067 (“Seller”), does hereby assign, grant, bargain,
transfer, sell, convey and deliver to Mainpointe Pharmaceuticals, LLC, a
Kentucky limited liability company, with offices at 333 East Main Street, Suite
220, Louisville, Kentucky 40202 (“Buyer”), all right, title and interest in and
to the Acquired Assets as such term is defined in the License, Commercialization
and Option Agreement dated as of the date hereof by and among Buyer and Seller
(the “Agreement”). Buyer hereby acknowledges that Seller is making no
representation or warranty with respect to the assets conveyed hereby except as
specifically set forth in the Agreement. Seller for itself, its successors and
assigns hereby covenants and agrees that, at any time and from time to time
forthwith upon the written request of Buyer, Seller will do, execute,
acknowledge and deliver or cause to be done, executed, acknowledged and
delivered, such further acts, deeds, assignments, transfers, conveyances, powers
of attorney and assurances as may reasonably be required by Buyer in order to
assign, transfer, set over, convey, assure and confirm unto and vest in Buyer,
its successors and assigns, title to the Acquired Assets sold, conveyed,
transferred and delivered by this Bill of Sale.

 

This Bill of Sale is being executed and delivered by Seller as of the date set
forth below pursuant to the terms of the Agreement.

 

Dated this ____ day of March, 2017

 

  SELLER:       ACURA PHARMACEUTICALS, INC.

 

  By:       Name:     Title:

 

 38 

 

 

EXECUTION COPY

 

Exhibit D

 

ACURA PHARMACEUTICALS, INC.

Patent Summary

 

 39 

 

 

ACURA PHARMACEUTICALS, INC.

Patent Summary as of 2/8/2017

 

ISSUED OR NOTICE OF ALLOWANCE

 

Case   Patent   File/Issue/Expire   Primary Claim(s)   Status 5014-00   US
8,901,113  

F-9/29/2010

I-12/2/2014

E-2/27/2032

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted 5014-01US  
14/552,067   F-11/24/2014   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)  
Allowed – Re-exam requested to fix typo.                   5014-AU   AU
2010300641  

F-9/29/2010

I-6/3/2016

E-9/29/2030

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted 5014-CA   CA
2,775,890  

F-9/29/2010

I-6/21/2016

E-9/29/2030

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted 5014-EP   EP
2,488,029  

F-9/29/2010

I-3/23/2016

E-9/29/2030

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted and validated in
Germany (60 2010 031 496.0), Spain, France, UK, Italy, 5014-HK   13102020.5  

F-9/29/2010

I-10/14/2016

E-9/29/2030

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted 5014-IL   IL 218533
 

F-9/29/2010

E-9/29/2030

  Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Granted

 

US APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5014-PR   61/247,225  
F-9/30/2009   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Expired 5014-PR2
  61/304,108   F-2/12/2010   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)  
Expired 5014-02US   15/426,296   F-2/7/2017   Drug+PEO+HPC+Disintegrant (incl
ethylcellulose)   Pending 5019-PR   61/842,424   F-7/2/2014   Meth precursor+gel
polymer+emulsifier+disintegrant+surfactant   Expired 5019-US   14/322,596  
F-7/2/2014   Meth precursor+gel polymer+ glycerol
monostearate+disintegrant+sodium lauryl sulfate   Published 5020-PR   62/009,600
  F-6/9/2014   PSE+Triglyceride+HPC+PEO+Disintegrant   Expired 5020-US  
14/734,364   F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant   Published

 

 40 

 

 

WO APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5014-WO  
PCT/US2010/050723  

F-9/29/2010

E-3/30/2012

  Drug+PEO+HPC+Disintegrant   Expired 5019-WO   PCT/US2014/045256  

F-7/2/2014

E-2/3/2016

  Meth precursor+gel polymer+emulsifier+disintegrant+surfactant   Expired
5020-WO   PCT/US2015/034786   F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant
  Expired

 

AU APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5014-01AU   2016204065  
F-9/29/2010   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Pending 5019AU  
2014284333   F-7/2/2014   Meth precursor+gel
polymer+emulsifier+disintegrant+surfactant   Pending 5020AU   2015274936  
F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant   Pending

 

CA APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5019CA   2,916,973  
F-7/2/2014   Meth precursor+gel polymer+emulsifier+disintegrant+surfactant  
Pending 5020CA   2,951,563   F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant
  Pending

 

CN APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5019CN   201480037082.5  
F-7/2/2014   Meth precursor+gel polymer+ glycerol
monostearate+disintegrant+sodium lauryl sulfate   Published 5020CN  
201580030318.7   F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant   Pending

 

 41 

 

 

EU APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5014-01EP   16161681.8  
F-9/29/2010   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Published 5019EP
  14820721.0   F-7/2/2014   Meth precursor+gel
polymer+emulsifier+disintegrant+surfactant   Published 5020EP   15807096.1  
F-6/9/2015   PSE+Triglyceride+HPC+PEO+Disintegrant   Pending

 

IL APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5014-IL   245734  
F-9/29/2010   Drug+PEO+HPC+Disintegrant (incl ethylcellulose)   Pending 5019IL  
242880   F-7/2/2014   Meth precursor+gel
polymer+emulsifier+disintegrant+surfactant   Pending

 

NZ APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status 5019NZ   716482  
F-7/2/2014   Meth precursor+gel polymer+ glycerol
monostearate+disintegrant+sodium lauryl sulfate   Pending

 

ISR APPLICATIONS

Case   App Number   Filed   Primary Claim(s)   Status                  

 

 42 

 

 

Exhibit E 

Form of Royalty Report.

 

ROYALTY REPORT Quarter Reported _________________   Licensee Name:   Property:  
Territory:   Address:   Contact:   Phone Number:   Fax Number:  

 

CURRENT QUARTER        Less:                  Territory
or
Territories  Gross
Sales   Deductions/
Returns*   Discounts   Net Sales   Royalty
Rate %   Royalty     $-   $-   $-   $-     %  $-     $-   $-   $-   $-     % 
$-     $-   $-   $-   $-     %  $-  Total  $-   $-   $-   $-     %  $- 

 

 43 

 

 

Exhibit F 

ASSET ALLOCATION

 

Item  Quantity (if applicable)   Amount   Comment              Assignment of
Contracts       $0                    Transferred Advertising Materials      
$0                    Equipment – See Schedule 3.2.1(b) for breakdown      
$102,743   Amount from NBV Columns on Schedule 3.2.1(b)                Raw
Materials Inventory – See Schedule 3.2.1(a) for breakdown       $97,475  
Consists of Raw Materials from Schedule 3.2.1(a)                Finished
Materials Inventory  - See Schedule 3.2.1(a) for breakdown       $109,159  
Consists of Finished Goods from Schedule 3.2.1(a)                Prepaid
Inventory (Half of Mikart PO 1050)       $115,643                    Total      
$425,020    

 

 44 

 

 

Exhibit G 

JOINT PRESS RELEASE

 

Acura Pharmaceuticals and MainPointe Pharmaceuticals
Announce Deal for Nexafed® Products

 

Expands Commercialization of Acura’s Methamphetamine-Resistant Pseudoephedrine
Products

 

PALATINE, IL, March XX, 2017: Acura Pharmaceuticals, Inc. (OTCQB: ACUR) and
MainPointe Pharmaceuticals, LLC today announced that they have entered into a
License Agreement (the "Agreement") to have MainPointe exclusively market
NEXAFED and NEXAFED Sinus in the US and Canada. The pseudoephedrine-containing
NEXAFED brand products utilize Acura’s IMPEDE® Technology which disrupts the
extraction and conversion of the pseudoephedrine into the illicit drug,
methamphetamine. MainPointe will assume all manufacturing and commercialization
activities from Acura.

 

“MainPointe is an emerging OTC pharmaceutical company that brings added leverage
to our NEXAFED business”, commented Bob Jones, Acura’s President and CEO. “With
additional products in distribution and new customer contacts, MainPointe is
well positioned to expand on the over 15,000 US pharmacy distribution achieved
by Acura over the past several years”.

 

“Conversion of pseudoephedrine products into methamphetamine remains an acute
problem in many communities”, said John Schutte, MainPointe’s President. “The
NEXAFED products have proven to be a success in curbing this costly problem and
we look forward to driving this business forward”.

 

The Agreement provided for an upfront cash payment of $2.5 million to Acura.
Acura is eligible to receive a royalty 7.5% based on commercial sales by
MainPointe.

 

About Acura Pharmaceuticals

Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the
research, development and commercialization of product candidates intended to
address medication abuse and misuse, utilizing its proprietary LIMITX™,
AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are
intended to reduce or limit the rate or extent of opioid release when multiple
tablets are ingested. AVERSION contains polymers that cause the drug to gel when
dissolved; it also contains compounds that irritate the nasal passages if the
product is snorted. IMPEDE is designed to disrupt the processing of
pseudoephedrine from tablets into methamphetamine.

 

OXAYDO® (oxycodone HCl immediate-release tablets) which incorporates the
AVERSION Technology, is FDA approved and marketed in the U.S. by our partner
Egalet Corporation.

 

 45 

 

 

NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products,
utilize the IMPEDE Technology.

 

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause our actual results, performance or achievements to
be materially different from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Forward-looking
statements may include, but are not limited to:

 

·our ability to fund or obtain funding for our continuing operations;

·the expected results of clinical studies relating to LTX-04 or any successor
product candidate, the date by which such study results will be available and
whether LTX-04 or any successor product candidate will ultimately receive FDA
approval;

·whether LIMITX will retard the release of opioid active ingredients as dose
levels increase;

·whether we will be able to reformulate LTX-04 or any successor product
candidate to provide an efficacious level of drug when one or two tablets are
taken;

·whether we will be able to reformulate LTX-04 or any successor product
candidate to improve its abuse deterrent performance;

·whether the extent to which products formulated with the LIMITX technology
deter abuse will be determined sufficient by the FDA to support approval or
labelling describing abuse deterrent features;

·whether our LIMITX technology can be expanded into extended-release
formulations;

·our and our licensee’s ability to successfully launch and commercialize our
products and technologies, including Oxaydo® Tablets and our Nexafed® products;

·our and our licensee’s ability to obtain necessary regulatory approvals and
commercialize products utilizing our technologies;

·the market acceptance of, timing of commercial launch and competitive
environment for any of our products;

·expectations regarding potential market share for our products;

·our ability to develop and enter into additional license agreements for our
product candidates using our technologies;

·the ability to avoid infringement of patents, trademarks and other proprietary
rights of third parties;

·the ability of our patents to protect our products from generic competition and
our ability to protect and enforce our patent rights in any paragraph IV patent
infringement litigation;

·the ability to fulfill the FDA requirements for approving our product
candidates for commercial manufacturing and distribution in the United States,
including, without limitation, the adequacy of the results of the laboratory and
clinical studies completed to date, the results of laboratory and clinical
studies we may complete in the future to support FDA approval of our product
candidates and the sufficiency of our development process to meet
over-the-counter (“OTC”) Monograph standards, as applicable;

·the adequacy of the development program for our product candidates, including
whether additional clinical studies will be required to support FDA approval of
our product candidates;

·changes in regulatory requirements;

 

 46 

 

 

·adverse safety findings relating to our commercialized products or product
candidates in development;

·whether the FDA will agree with our analysis of our clinical and laboratory
studies;

·whether further studies of our product candidates will be required to support
FDA approval;

·whether or when we are able to obtain FDA approval of labeling for our product
candidates for the proposed indications and whether we will be able to promote
the features of our abuse discouraging technologies; and

·whether Oxaydo or our Aversion and LIMITX product candidates will ultimately
deter abuse in commercial settings and whether our Nexafed products and Impede
technology product candidates will disrupt the processing of pseudoephedrine
into methamphetamine.

 

In some cases, you can identify forward- looking statements by terms such as
"may," “will”, "should," "could," "would," "expects," "plans," "anticipates,"
"believes," "estimates," “indicates”, "projects," predicts," "potential" and
similar expressions intended to identify forward-looking statements. These
statements reflect our current views with respect to future events and are based
on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. We discuss many of these risks in greater detail in our filings with
the Securities and Exchange Commission.

 

Contact:

for Acura Investor Relations

investors@acurapharm.com

847-705-7709

 

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