Exhibit 10.28

 

Confidential Information

 

SETTLEMENT AND LICENSE AGREEMENT

 

This Settlement and License Agreement (the “Agreement”) is entered into this 7th
day of October, 2010 (the “Agreement Date”), by and between Anesta AG and
Eurand, Inc., each on their own behalf and on behalf of their Affiliates, and
Impax Laboratories, Inc., on its own behalf and on behalf of its Affiliates.

 

WHEREAS, there is now pending in the United States District Court for the
District of Delaware a lawsuit filed by Anesta and Eurand against Impax
Laboratories, Inc., Civil Action No. 09-018, involving United States Patent
No. [**]; and

 

WHEREAS, Impax has filed counterclaims against Anesta and Eurand in the
Litigation, [**]; and

 

WHEREAS, the parties wish to settle the Litigation;

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
representations, covenants and conditions herein set forth, the receipt and
sufficiency of which consideration are hereby acknowledged, the parties agree as
follows:

 

1.                                      DEFINITIONS

 

For purposes of this Agreement, the terms set forth hereinafter shall be defined
as follows:

 

1.1.          “Affiliate” of, or any entity “Affiliated” with, a specified
entity shall mean any corporation, company, partnership, joint venture or other
legal entity that controls, is controlled by, or is under common control with
the entity specified, where “control” means 50% or greater equity ownership or
the ability to direct management activity.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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1.2.          “AMRIX®” shall mean the drug listed in the FDA Orange Book under
NDA 21-777, cyclobenzaprine hydrochloride extended release capsule, and any
supplements thereto relating to additional strengths.

 

1.3           “Anesta” shall mean Anesta AG and all of its Affiliates including
but not limited to Cephalon, Inc. (“Cephalon”).

 

1.4.          “Anesta and Eurand” shall mean Anesta AG and Eurand, Inc., and all
of their Affiliates.

 

1.5           “Applicable Law(s)” shall mean applicable laws, rules, statutes,
codes, regulations, orders, judgments, ordinances or requirements of any court,
tribunal, agency, legislative body, commission or instrumentality of any
federal, state, province, county or city government related to the development,
registration, manufacturing or marketing of pharmaceutical products in the
Territory, or the performance of the Parties’ obligations under this Agreement.

 

1.6.          “At-Risk Launch”  shall mean the [**].

 

1.7.          “At-Risk Launch Period” shall mean the period starting on the date
of an At-Risk Launch and ending on the date that is the earlier of:  (i) the
date the Third Party/Parties who undertook the At-Risk Launch stops the
commercial sale of Generic Equivalent Product, either as required by Court order
or otherwise; (ii) the date of a final, non-appealable judgment of invalidity,
unenforceability or non-infringement of claims asserted against such Third Party
of any Orange Book Patents; or (iii) the License Effective Date occurs pursuant
to Sections 3.2(a), (b), (c) or (e).

 

1.8.          “Authorized Generic Product” shall mean the listed product,
AMRIX®, that is marketed, sold, or distributed directly or indirectly to retail
class of trade with labeling,

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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packaging, product code, labeler code, trade name, or trademark that differs
from that of AMRIX.

 

1.9           “Confidential Information” shall mean all confidential or other
proprietary information that is disclosed by one Party (the “disclosing party”),
to another Party (the “receiving party”), during the term of this Agreement. 
When a disclosing party provides Confidential Information to a receiving party,
such information should be marked as “Confidential”, “Restricted” or
“Proprietary” (or with words of similar import) at the time of first written
disclosure or if first disclosed orally or visually, then designated as
“Confidential”, “Restricted” or “Proprietary” (or with words of similar import)
within thirty (30) days of the oral or visual disclosure, provided, however, any
proprietary or confidential information that the receiving party, through the
exercise of reasonable judgment, understands or should understand to be
confidential or proprietary, shall also be considered Confidential Information
of the disclosing party for purposes of this Agreement.  Information which:
(i) is or becomes public knowledge without any action by, or involvement of, the
receiving party; (ii) is disclosed by the receiving party with the prior written
approval of the disclosing party; (iii) is intentionally disclosed by the
disclosing party to a third party without restriction on disclosure; or (iv) is
rightfully received by the receiving party from a third party without a duty of
confidentiality, shall not be deemed Confidential Information, even if such
information is so identified by the disclosing party.  For the avoidance of
doubt, this Agreement shall constitute Confidential Information of both Parties.

 

1.10.        “Covered Patents” shall mean [**].

 

1.11.        “Eurand” shall mean Eurand, Inc., and all of its Affiliates.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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1.12.        “FDA” shall mean the United States Food and Drug Administration or
any successor agency thereof.

 

1.13.        “First to File Exclusivity” means the period of one hundred eighty
(180) days of marketing exclusivity in the Territory granted by FDA under and
pursuant to 21 U.S.C. section 355(j)(5)(B)(iv).

 

1.14.        “Fully Allocated Manufacturing Costs” shall mean [**].

 

1.15.        “Generic Equivalent Product” shall mean (a) a pharmaceutical
product which has been approved by or submitted for approval to FDA under an
ANDA as a therapeutic equivalent (as defined in FDA regulations) to AMRIX®, or
(b) an Authorized Generic Product.

 

1.16.        “Gross Profits” shall mean [**].

 

1.17.        “Impax” shall mean Impax Laboratories, Inc., and all of its
Affiliates.

 

1.18.        “Impax ANDA Product” shall mean [**].

 

1.19.        “Impax Authorized Generic Product” shall mean an Authorized Generic
Product supplied to Impax by, or on behalf of, Anesta and/or Eurand.

 

1.20.        “Licensed Patents” shall mean Covered Patents and Orange Book
Patents.

 

1.21.        “License Effective Date” shall have the meaning provided in
Section 3.2 below.

 

1.22.        “Licensed Product” shall mean either the Impax ANDA Product or the
Impax Authorized Generic Product.

 

1.23.        “Net Sales” shall mean, [**].

 

1.24.        “Orange Book Patents” shall mean any and all patents that are
listed, now or in the future, in the Orange Book in relation to NDA No. 21-777
(Anesta’s AMRIX® product).

 

1.25         The “Parties” shall mean collectively, Anesta, Eurand, and Impax.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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1.26.        “Person” shall mean an individual, corporation, partnership or
other entity and its Affiliates.

 

1.27.        “Quarterly Period” shall mean that three (3) month period of the
calendar year ending on March 31, June 30, September 30 and December 31,
respectively.

 

1.28.        “Sales and Distribution Costs” means, [**].

 

1.29.        “Territory” shall mean the United States and its territories and
possessions, including Puerto Rico.

 

1.30.        “Third Party” shall mean a party that is neither Anesta, Eurand,
nor Impax.

 

1.31.        “Third Party Licensed Product” shall mean a Generic Equivalent
Product sold by a Third Party pursuant to authorization or license from Anesta
and/or Eurand.

 

1.32.        “Transfer Price” shall [**].

 

1.33.        “Valid Patent Claim” shall mean an unexpired claim in any issued
Orange Book Patent which has not been held invalid or unenforceable by a
decision of a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable by the owner through reissue or
disclaimer.  If there should be two or more such decisions conflicting with
respect to the validity of the same claim, the decision of the higher or highest
tribunal shall thereafter control; however, should the tribunals be of equal
dignity, the decision or decisions holding the claim valid shall prevail, unless
and until the invalidity decision becomes a final, non-appealable decision.

 

2.                                      SETTLEMENT TERMS

 

2.1.          Stipulation and Dismissal of the Litigation

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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The parties agree to execute a stipulation for the dismissal of the Litigation
with prejudice, and without cost to either party.  The proposed stipulated
dismissal shall be jointly submitted to the Court within five (5) business days
of the Agreement Date.

 

2.2.          Anesta, Cephalon, and Eurand’s Release

 

[**].

 

2.3.          Impax’s Release

 

[**].

 

2.4           Acknowledgement of Infringement, Validity and Enforceability [**]

 

Impax hereby stipulates [**].  Notwithstanding the foregoing, no admission made
in this Section 2.4 (including admissions regarding validity and enforceability)
shall apply outside the United States or to any product other than the Licensed
Products.

 

2.5           Agreement Not to Assist Third Parties

 

Impax covenants not to assist, coordinate with, or otherwise help any Third
Party in prosecuting, defending or settling litigation regarding any Covered
Patent in connection with a Third Party Generic Equivalent Product in any
context or forum, including but not limited to any court or proceeding before
the United States Patent and Trademark Office (including reexamination
proceedings).

 

2.6           Agreement Not to Challenge Validity or Enforceability

 

Solely with respect to the Licensed Product, Impax covenants not to challenge
the validity or enforceability of any claim of the Licensed Patents in any
context or forum in the Territory, including but not limited to any court or
USPTO proceeding (including reexamination proceedings), including, but not
limited to, initiating a declaratory judgment action with respect to any of the
Licensed Patents.  Notwithstanding the foregoing, if Anesta, Eurand or their

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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Affiliates or any third party with rights to enforce the Covered Patents brings
an action against Impax for infringement of any of the Covered Patents, Impax
may assert any defense with respect to said patent only, except if such action
is in consequence of breach of this agreement by Impax in which case paragraph
3.7 of this Agreement shall govern such action.  With respect to products other
than the Licensed Product, nothing herein shall limit or restrict Impax’s
ability to challenge the validity or enforceability of the Licensed Patents or
asserting that such products do not infringe any claim of the Licensed Patents.

 

2.7           Impax Agreement to Abide by License Effective Date

 

Except as permitted under the license in Section 3 below, Impax agrees not to
(i) make, use, import, offer to sell, or sell in the Territory, (ii) actively
induce or assist any other entity to make, use, import, offer to sell or sell in
the Territory, or (iii) import or cause to be imported in the Territory, the
Licensed Product before the License Effective Date, except as permitted by the
License in Section 3 of this Agreement.

 

3.                                      LICENSE TERMS

 

3.1.          Grant

 

Subject to the terms and conditions herein, Anesta and Eurand hereby grant to
Impax a non-exclusive license under the Licensed Patents: (i) to make, have
made, or offer to sell the Impax ANDA Product, effective as of the Agreement
Date, but only for the limited purpose of preparing for a launch of the Licensed
Product consistent with the terms of this Agreement, and (ii) to promote, use,
import, and sell Licensed Product in the Territory as of the License Effective
Date.  Impax shall not have the right to sublicense the Licensed Patents to any
Third Party.  In connection with the above license, Eurand shall not be required
to transfer any know how, trade secrets or other information relating to its
manufacture or formulation of any product to Impax.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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3.2.          License Effective Date

 

The “License Effective Date,” shall be the date which is the earliest of:

 

(a)                                  The later of February 26, 2024 or, in the
event the date of expiration of US Patent No. 7,387,793 is extended under 35
U.S.C. § 154(b) (“Extension of Patent Term”), 21 U.S.C. § 355 (“Pediatric
Studies of Drugs”), or under both such provisions of law, the date that is one
year earlier than the date of expiration of the patent as extended;

 

(b)                                 In the event that Anesta and/or Eurand
license or authorize any Third Party who is entitled to First to File
Exclusivity to sell Generic Equivalent Product in the Territory, on the date
immediately following the expiration of any applicable First to File Exclusivity
period after that first filer begins the commercial sale of its Generic
Equivalent Product;

 

(c)                                  the same entry date that any Third Party
which is not entitled to First to File Exclusivity is licensed or authorized by
Anesta and/or Eurand to begin selling Generic Equivalent Product in the
Territory;

 

(d)                                 the date of an At-Risk Launch, provided that
the license granted pursuant to this Section 3.2(d) shall only extend for the
At-Risk Launch Period, after which Impax shall immediately exit the market
unless the license has become effective under another provision of this
Section 3.2; and

 

(e)                                  The date that a Third Party obtains a
final, non-appealable judgment of invalidity, unenforceability or
non-infringement of all asserted claims of any Orange Book Patents, following
the expiration of any applicable First to File Exclusivity period.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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Anesta and Eurand will notify Impax [**] following any settlement with any other
defendant that would result in a License Effective Date earlier than that
provided in § 3.2(a).

 

3.3.          Exclusivity waiver.  Anesta and Eurand hereby agree to waive any
period of regulatory exclusivity to the extent such exclusivity would preclude
or impede the launch of the Impax ANDA Product as of the License Effective
Date.  Anesta and Eurand agree to provide reasonable cooperation to Impax in
connection with such waiver, including by submitting a mutually agreeable notice
to FDA of the existence of such waiver and not opposing the approval of Impax
ANDA Product effective as of the License Effective Date based on any applicable
regulatory exclusivity in force at the time.  Such notice will be delivered by
Anesta to FDA within five (5) business days of receipt of written request from
Impax.  For purposes of clarity, nothing in this Section 3.3 is intended to or
does accelerate the License Effective Date as determined under Section 3.2.

 

3.4           Transfer Price and Royalties.

 

3.4.1        In addition to the Royalties specified in Section 3.4.2
below, Impax shall pay Eurand the Transfer Price for all Authorized Generic
Product purchased by Impax from Eurand.

 

3.4.2        Royalties shall be paid to Anesta as follows:

 

a)                      License Effective Date of 3.2(a), (b), (c) or (e):

 

1) [**].

 

b)                     License Effective Date of 3.2(d) (At-Risk Launch)

 

1) [**].

 

2) [**].

 

3.5.          Royalty Term

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

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Impax’s obligation to pay the royalties pursuant to paragraphs 3.4.2(a) and
3.4.2(b), as applicable, shall remain in effect [**].

 

3.6.          Accounting and Records

 

(a)           [**]the Quarterly Period in respect of which payments are due
under paragraph 3.4, Impax shall prepare and send to Anesta a report setting
forth [**] during such Quarterly Period, which report shall [**].  All reports
submitted hereunder shall be deemed Impax Confidential Information pursuant to
Section 5.

 

(b)           Simultaneously with the submission of each report pursuant to
paragraph 3.6(a), Impax shall, in a commercially reasonable manner, make
payments, in United States currency, to Anesta or to a party or parties
designated by Anesta, of the amounts due for the period covered by the report. 
In the event any payments are made later than the dates set forth herein, Impax
shall also pay interest on such late payments, [**].  Impax shall be entitled to
make all payments by corporate check or wire transfer.

 

(c)           All payments to Anesta required under this Agreement shall be made
to the name or account of Anesta or a party or parties designated by Anesta at
an address designated by Anesta.  Any and/or all of such payments shall be
subject to such withholding tax laws, rules and regulations as may be applicable
and, if such laws, rules or regulations require a withholding to be made, such
payment(s) will be reduced by such amount(s) withheld and the payment of (a) the
reduced amount(s) to Anesta and (b) the withheld amount to the taxing agency or
body shall constitute full compliance of Impax’s payment obligation under this
Agreement.  Impax shall provide to Anesta appropriate proof of payment of any
and all such taxes withheld.  Impax shall timely pay any such taxes withheld and
any penalty or surcharge assessed to Impax or Anesta for late payment of such
taxes.

 

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**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

10

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(d)           Impax shall keep accurate records in respect of all sales of the
Licensed Product by Impax and its Affiliates and shall maintain such records
[**].  Anesta shall have the right, at its sole cost and expense, [**], to have
Impax’s records reviewed [**] at times that are reasonably convenient to Impax,
using an independent certified public accountant designated by Anesta, provided
the independent accountant signs a confidentiality agreement with Impax
providing that such records, books of account, information and data shall be
treated as Confidential Information which may be disclosed only to Anesta.  Any
report rendered by Impax prior to the date of such review and to which Anesta
raises no reasonable written objection [**] shall be deemed conclusive and
binding, provided that Impax has not unreasonably impeded such review.  If the
review determines that [**] reported by Impax for such Quarterly Period pursuant
to paragraph 3.6(a), then [**].  Any deficiencies in payment shall be payable
with interest from the date the initial payment was due at the rate specified in
paragraph 3.6(b).

 

(e)           At the termination of this Agreement, Impax shall render a final
report to Anesta [**] the end of the Quarterly Period in which such termination
occurs, and payments shall be made to Anesta for that Quarterly Period (or
portion thereof) in which such termination occurs.

 

3.7.          Consequence of Breach by Impax

 

In the event of a judicial determination, after hearing before the United States
District Court for the District of Delaware, that Impax sold or distributed the
Licensed Product before the License Effective Date, [**].

 

[**]

 

4.             AUTHORIZED GENERIC

 

4.1           At any time that is prior to the License Effective Date, Impax may
elect by providing written notice to Eurand and Anesta to have Eurand supply
Impax Authorized

 

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**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

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Generic Product to Impax for sale in the Territory from and after the applicable
License Effective Date subject to all of the terms and conditions of this
Agreement.  Anything in this agreement to the contrary notwithstanding, [**],
Eurand will use [**] supply Impax Authorized Generic Product to Impax by the
License Effective Date or as soon thereafter as is reasonably practical.

 

4.2           Supply of Impax Authorized Generic Product; Forecasts; Purchase
Orders.

 

(a)           Subject to the terms, conditions and limitations hereof, during
the Supply Term, Eurand agrees to supply Impax Authorized Generic Product to
Impax for marketing and in accordance with the terms of this Agreement.  In
order to be in a position to timely and effectively enter the generic market,
the Parties shall cooperate in good faith to determine and prepare for the
applicable License Effective Date, including communicating to one another, on an
ongoing basis, developments which may reasonably affect the License Effective
Date and information necessary to label the Impax Authorized Generic Product for
sale as a generic by Impax.

 

(b)           All Impax Authorized Generic Product supplied will be supplied in
bulk form which complies with Anesta’s NDA.  Subject to compliance with Anesta’s
NDA, Impax will provide Eurand and Anesta with appropriate and customary generic
package and label design for Anesta’s and Eurand’s approval prior to Impax
packaging the Impax Authorized Generic Product, such approval not to be
unreasonably withheld.  Impax will provide Anesta with final specimens.  Eurand
and Anesta will timely make all appropriate regulatory filings in order to
enable Impax to package the Impax Authorized Generic Product at the Impax site.
Any

 

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**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

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costs incurred by Eurand in performing other manufacturing specifications (such
as capsule imprints) requested by Impax (all of which must be consistent with
the approved specifications under the NDA) and to which Eurand agrees (such
agreement not to be unreasonably withheld, delayed or conditioned), including
related capital expenditures, shall be at Impax’s sole cost and expense.

 

(c)           At the time Impax provides notice under Section 4.1 that it elects
to market Impax Authorized Generic Product, [**] before the date Impax requests
delivery of Launch Quantities (subject to Section 4.1), Impax will provide to
Eurand a good faith Forecast (as defined below) of the quantities of Impax
Authorized Generic Product required for the initial Launch of Impax Authorized
Generic Product ([**], beginning with the License Effective Date) (the “Launch
Quantities”).  The Launch Quantities may be adjusted from time to time by Impax,
upon the consent of Eurand (not to be unreasonably withheld, delayed or
conditioned), based on reasonable assessments of changes in market conditions. 
In anticipation of the Launch of Impax Authorized Generic Product by Impax,
Eurand shall use commercially reasonable efforts to deliver the Launch
Quantities as soon as practicable to Impax on or before the License Effective
Date, so that Impax may Launch on the License Effective Date.  Notwithstanding
the foregoing, in the event the License Effective Date occurs under
Section 3.2(d) due to an At-Risk Launch earlier than Impax’s requested delivery
of Launch Quantities, the parties shall reasonably cooperate to supply Launch
Quantities requested by Impax to enable Impax to launch Impax Authorized Generic
Product

 

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**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

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as soon as reasonably practicable following the License Effective Date under
Section 3.2(d).

 

(d)           [**] following the License Effective Date, and [**] thereafter
beginning with the date [**] the License Effective Date, Impax shall deliver a
forecast (a “Forecast”) to Eurand of the quantities of Impax Authorized Generic
Product, by SKU, which Impax reasonably anticipates it will require for
marketing [**] the License Effective Date in the first instance, and thereafter
[**] the date of such Forecast and shall include quantities required to be
delivered [**] of the Forecast Period.  The foregoing notwithstanding, the first
such Forecast shall be for [**] after the License Effective Date.  For each such
Forecast, [**] of the Forecast Period shall be known as the “Purchase Order
Period” and the amounts specified in the Forecast for the Purchase Order Period
shall constitute a binding purchase order for such period.  Additionally, in
each subsequent Forecast, the amount ordered for the Purchase Order Period shall
not deviate [**] (as to the entire period or any month therein) from [**] of the
immediately preceding Forecast.  Other than the specifically provided in this
paragraph, the amounts set forth in the Forecasts shall only constitute a
non-binding estimate of the Impax Authorized Generic Product requirements.

 

(e)           Eurand shall use commercially reasonable efforts to make
deliveries of Impax Authorized Generic Product [**] of the agreed upon delivery
dates, which delivery dates shall be at least [**] from the date a binding
purchase order is received by Eurand.  All such shipments of Impax Authorized
Generic Product shall be [**] Eurand’s manufacturing facilities to a carrier
designated by Impax.

 

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**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

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Title and risk of loss shall pass, and delivery shall occur, [**].  In no event
shall Eurand be required to [**].  The terms and conditions of this Agreement
shall be controlling over any conflicting terms and conditions stated in Impax’s
purchase order or Eurand’s invoice or confirmation.  Any other document which
shall conflict with or be in addition to the terms and conditions of this
Agreement is hereby rejected (unless the Parties shall have mutually agreed to
the contrary in writing in respect of a particular instance).

 

(f)            Eurand shall promptly notify Impax in writing if at any time
Eurand has reason to believe that Eurand will not be able to [**] in accordance
with the delivery schedule specified herein pursuant to the terms and conditions
of this Agreement.

 

(g)           Eurand shall invoice Impax at the time of each shipment of Impax
Authorized Generic Product at the Transfer Price for such shipment.  Impax shall
pay each such invoice [**].

 

(h)           In addition to the foregoing, the Parties shall work together in
good faith and make commercially reasonable efforts to timely satisfy any
changes in the quantities and delivery dates of Impax Authorized Generic Product
specified in the Forecasts due to changes in demand.

 

(i)            Impax Authorized Generic Products supplied by Eurand shall
(i) have a shelf life[**] and (ii) conform to Anesta’s NDA.  The foregoing
notwithstanding, the Launch Quantities shall instead have a shelf life [**].

 

(j)            All Impax Authorized Generic Products will be supplied by Eurand
as bulk capsules packaged in drums, as described in Section 4.2(b) above and in

 

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**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

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accordance with the terms and conditions of this Agreement, Anesta’s NDA, the
Eurand/Impax Quality Agreement (as defined below) , and Applicable Laws.

 

(k)           Impax shall be solely responsible for packaging and labeling the
bulk product provided by Eurand into the finished dosage form in accordance with
this Agreement, the Anesta/Impax Quality Agreement, and Applicable Laws.  For
clarity, Impax acknowledges that if it chooses not to use a site currently
authorized under the NDA, or if it chooses to use a container closure system not
specified in the NDA, additional regulatory filings will be required, possibly
resulting in delays pending FDA approval.  Anesta will reasonably cooperate with
Impax in timely making the appropriate regulatory filings.

 

(l)            During the Term, and for a period of [**] thereafter, Eurand
shall, and shall ensure that its Affiliates shall, keep at either its normal
place of business, or at an off-site storage facility, detailed, accurate and up
to date information and data contained in any invoices provided to Impax in
connection with this Agreement.

 

4.3          Quality Assurance; Acceptance

 

(a)           Eurand represents, covenants and warrants to Impax that:

 

(i)            all Impax Authorized Generic Product hereunder shall be produced
in accordance with cGMP, and Applicable Laws, rules and regulations and that
none of the Impax Authorized Generic Product supplied hereunder shall be
adulterated or misbranded as defined by Applicable Law; and

 

--------------------------------------------------------------------------------

**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

16

--------------------------------------------------------------------------------

 

(ii)           all shipments of Impax Authorized Generic Product supplied
hereunder shall at the time of delivery, meet the specifications set forth in
Anesta’s NDA (including expiration dating).

 

(b)           Eurand will use commercially reasonable efforts to maintain
throughout the term of this Agreement all permits, licenses, registrations and
other forms of governmental authorization and approval required in order for
Eurand to perform its obligations hereunder in accordance with all Applicable
Laws.

 

(c)           to Eurand’s knowledge upon due investigation, as of the Effective
Date the manufacture or marketing of the Impax Authorized Generic Products in
the Territory pursuant to this Agreement does not infringe, misappropriate or
otherwise conflict with any intellectual property rights of any Third Party.

 

(d)           Eurand shall perform all quality control tests and other
inspections required by applicable cGMP standards and Anesta’s NDA and shall
furnish to Impax a certificate of analysis together with each lot of Impax
Authorized Generic Product shipped to Impax.  Eurand will also provide Impax
with Material Safety Data Sheets (hereinafter “MSDS”) for the Impax Authorized
Generic Products, and updates of same as necessary, but in no event will Eurand
provide any specifications and/or quality control standards under the NDA beyond
those necessary for Impax to conduct the testing specified in subparagraph
4.3(f).

 

(e)           Anesta will promptly notify Impax of any request from the FDA to
change Impax Authorized Generic Product specifications or labeling and will
notify Impax of any changes in specifications.

 

--------------------------------------------------------------------------------

**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

17

--------------------------------------------------------------------------------

 

(f)            Impax shall conduct, at its own expense, such tests as it deems
necessary to determine the compliance of the Impax Authorized Generic Product
with the requirements of Section 4.3(a).  Impax shall notify Eurand and Anesta
within thirty (30) days of its receipt of each shipment of the Impax Authorized
Generic Product of any non-compliance of the Impax Authorized Generic Product
with the requirements of Section 4.3(a) revealed by such testing, and with
respect to any latent defect, within ten (10) days of becoming aware of such
defect and provide documents alleged to support any such contention.

 

(g)           Subject to the provisions of Section 4.3(h), Eurand shall replace,
at its own expense, including all freight costs, any Impax Authorized Generic
Product that does not meet the requirements of Section 4.3(a) upon delivery
(including shelf life dating).

 

(h)           If, no more than 30 days following the timely delivery of a notice
by Impax pursuant to the provisions of Section 4.3(f), Impax and Eurand do not
agree that any lot or lots of the Impax Authorized Generic Product referred to
in the notice meets the requirements of Section 4.3(a), that lot or those lots
of the Impax Authorized Generic Product shall be tested for such compliance,
within thirty (30) days after notice of the defect is delivered to Eurand, by a
disinterested Third Party expert selected by the mutual agreement of Impax and
Eurand.  The decision of such Third Party expert with respect to the question of
compliance shall be binding upon Impax and Eurand for the purposes of
Section 4.3(g) of this Agreement.  The costs of such testing shall be borne by
Eurand if such lot or lots

 

--------------------------------------------------------------------------------

**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

18

--------------------------------------------------------------------------------

 

are found not to meet the requirements of Section 4.3(a) and by Impax in all
other circumstances.

 

(i)            Impax represents, covenants and warrants to Eurand that all Impax
Authorized Generic Product marketed by Impax will be packaged, labeled, stored,
shipped and handled in accordance with cGMP, Anesta’s NDA, and all Applicable
Laws.

 

4.4          Regulatory Responsibilities; Adverse Event Reporting; Recalls

 

(a)           Anesta will have sole authority to deal with regulatory matters
relating to Anesta’s NDA or Impax Authorized Generic Product.  During the term
hereof, Anesta shall maintain Anesta’s NDA in accordance with all applicable
requirements of the FDA, including, without limitation, the filing of all annual
requirements and other reports or filings required by the FDA.  Impax shall
provide Anesta all information as required for Anesta to submit regulatory
filings, including annual reports, as required by FDA in accordance with a
schedule as specified by Anesta or its Affiliates.

 

(b)           Impax shall submit to Anesta all reports of adverse drug
experiences, together with all relevant information possessed by it, in time for
Anesta to meet all expedited and periodic regulatory obligations to the FDA. 
Impax shall also promptly submit to Anesta all Impax Authorized Generic Product
inquiries or complaints for handling by Anesta.  Each Party shall cooperate with
the other and provide information in its possession to the extent necessary for
the other Party to comply with all legal requirements relating to the
manufacture or marketing of Impax Authorized Generic Product.

 

--------------------------------------------------------------------------------

**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

19

--------------------------------------------------------------------------------

 

(c)           Each of Eurand, Anesta and Impax will immediately inform the other
in writing if it believes one or more lots of any Impax Authorized Generic
Product should be subject to recall from distribution, setting forth the reasons
therefore with reasonable specificity.  To the extent permitted by legal or
public safety requirements, the Parties will confer before initiating any
recall.  [**].  The Party initiating the recall shall initially bear the cost
thereof and shall carry out the recall in accordance with best industry
practices.  In the event it is determined that a recall resulted from a breach
by Eurand of any of its representations or warranties set forth in
Section 4.3(a) hereunder, [**].

 

(d)           Eurand shall keep, or cause its Affiliates to keep, as required,
such samples and such records (or copies thereof) in respect of the Impax
Authorized Generic Products as are required by Applicable Law for such period of
time as may be required thereunder.

 

(e)           Each of Eurand, Anesta, and Impax shall promptly inform the other
of any correspondence from the FDA that would materially affect its ability to
meet its obligations under this Agreement.  Eurand shall notify Impax promptly,
but in no event later than ten (10) business days following the occurrence of
any materially adverse inspections by the FDA or other regulatory authorities
which pertain to the Impax Authorized Generic Products or to the facilities
where the Impax Authorized Generic Products are being manufactured or stored.

 

(f)            Within forty-five (45) days following the date that Impax
provides notice to Eurand that it elects to be supplied Impax Authorized Generic
Product under Section 4.1, Eurand and Impax shall enter into a Quality Agreement
in form and

 

--------------------------------------------------------------------------------

**   Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.

 

20

--------------------------------------------------------------------------------

 

content reasonably acceptable to Impax and Eurand (“Eurand/Impax Quality
Agreement”) and within 45 days following the date that Impax provides notice to
Anesta that it elects to be supplied with Impax Authorized Generic Product under
Section 4.1, Impax and Anesta (and Eurand, if Eurand so elects) shall enter into
a Quality Agreement in form and content reasonably acceptable to Impax and
Anesta (“Impax/Anesta Quality Agreement”).  The Impax/Anesta Quality Agreement
will include protocols and specific quality responsibilities for handling Impax
Authorized Generic Product quality complaints, ADE reports, and professional
medical services inquiries in accordance with Anesta’s standard operating
procedures and in conformity with Applicable Laws.

 

(g)                                 Impax and Anesta (and Eurand if Eurand so
elects) shall meet within thirty (30) days from the date that Impax provides
notice under Section 4.1 to negotiate in good faith and agree on a process and
procedure for sharing adverse event information which shall be documented in a
pharmacovigilance agreement (“PVA”).  Also, upon execution of this Agreement,
each Party shall assign a representative to ensure such a pharmacovigilance
agreement is adopted prior to the Impax Authorized Generic Product being
distributed and marketed.  Following adoption of the PVA, the parties shall
ensure the prompt exchange of any and all information concerning adverse events
related to use of the Impax Authorized Generic Product regardless of source,
complying with the contents of the PVA and legal requirements in their
respective territories.

 

(h)                                 Consistent with Anesta’s obligations as NDA
holder, if Impax elects to create and/or distribute any promotional material for
an Impax Authorized

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

21

--------------------------------------------------------------------------------

 

Generic Product, such promotional materials shall be subject to Anesta’s prior
written approval for the limited purpose of ensuring that they comply with any
obligations under the NDA, such approval not to be unreasonably withheld.  Impax
shall ensure that its promotional materials contain no representations,
warranties, or claims with respect to an Impax Authorized Generic Product,
except as approved in writing by Anesta pursuant to this paragraph.  For
purposed of clarity, if Impax elects to distribute Impax Authorized Generic
Product, Impax at a minimum shall be permitted to disclose that such product is
an Authorized Generic Product.

 

5.                                      CONFIDENTIALITY

 

5.1                                 Confidentiality.  During the term of this
Agreement and for a period of [**], the Parties shall maintain as confidential
and not disclose to any Third Party any Confidential Information supplied by
another Party.  The Parties shall use the Confidential Information of the other
Parties solely for the performance of their respective obligations under this
Agreement.

 

5.2                                 Exclusions.  The obligations of
confidentiality and non-use under Section 5.1 shall not apply to any information
that: (i) is shown by contemporaneous documentation of the receiving Party to
have been in its rightful possession on a non-confidential basis prior to
receipt from the disclosing Party; (ii) is or becomes, through no fault of the
receiving Party, publicly known; (iii) is furnished to the receiving Party by a
Third Party without breach of a duty to the disclosing Party; or (iv) is
independently developed by the receiving Party without access to the
Confidential Information of the disclosing Party.

 

5.3                                 Exceptions.  Notwithstanding Section 5.1, a
Party receiving Confidential Information may disclose such Confidential
Information to the extent that such disclosure has

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

22

--------------------------------------------------------------------------------

 

been ordered by a court of law or otherwise required by law or regulation,
provided that the disclosure is limited to the extent ordered or required and
wherever practicable, the Party owning the Confidential Information has been
given written notice in advance in order to enable it to seek protection or
confidential treatment of such Confidential Information.  In the event any Party
determines that disclosure of this Agreement or any terms of this Agreement is
required under applicable securities laws or regulations, such party shall
provide the proposed disclosure in writing to the other Parties for an
opportunity to comment thereon.  Such proposed disclosure shall be provided [**]
the date of the disclosure, provided, however, that if the disclosing Party is
required to make the disclosure in a shorter period of time, such Party will
nonetheless give the other Parties such notice and as much opportunity to
comment thereon as is practical in advance of such disclosure.

 

5.4                                 Notwithstanding the foregoing, Anesta shall
have the right to disclose this Agreement and any other documents associated
with it to ECR Pharmaceuticals, Inc. (“ECR”) and/or its representatives for the
limited purpose of satisfying obligations to ECR under Anesta’s agreement (as
amended) with ECR related to the acquisition of AMRIX, provided that such
disclosure is undertaken under a confidentiality agreement preventing further
disclosure of this Agreement and any other documents associated with it that are
subject to paragraph 5.1.

 

5.5                                 Impax understands that Anesta and Eurand are
currently and may in the future be in patent litigation against Third Parties
relating to Third Party Generic Equivalent Products (“non-Impax litigations”),
and that ANDA 90-771 and related FDA correspondence produced by Impax in the
Litigation (“Impax Documents”) [**].

 

For the avoidance of doubt, the Protective Order in the Litigation remains in
full force and effect except as expressly modified herein, including but not
limited to Anesta’s and

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

23

--------------------------------------------------------------------------------

 

Eurand’s obligation to destroy all information and documents produced by Impax
in the Litigation other than the Impax Documents.  [**].

 

6.                                      ADDITIONAL TERMS OF AGREEMENT

 

6. 1                              Parties in Interest

 

The parties hereby represent and warrant to each other that they have not sold,
assigned, transferred, conveyed or otherwise disposed of any right or claim
covered or released by this

 

Agreement and that they have the authority to enter into this Agreement.

 

6.2                                 Successors and Assigns

 

This Agreement shall be binding upon and inure to the benefit of and be
enforceable by the parties hereto and their respective successors and assigns. 
This Agreement may not be assigned by either party without the prior written
consent of the other, which consent shall not be unreasonably withheld.

 

6.3                                 All Negotiations and Representations
Superseded — Entire Agreement

 

This Agreement, the Eurand/Impax Quality Agreement, the Impax/Anesta Quality
Agreement, the Transfer Price Agreement between Eurand and Impax, and PVA (if
applicable) are the entire agreements between the parties and supersede any and
all prior negotiations and understandings among all of the parties concerning
the subject matter hereof.

 

6.4                                 Representation by Impax

 

Impax represents that ANDA No 90-771 is its only application for approval
referencing the AMRIX® product, and further represents that it neither filed nor
assisted in the Suitability Petition currently docketed at the FDA as Docket
No. FDA 2009 P 0168.

 

6.5                                 Representations by Eurand and Anesta

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

24

--------------------------------------------------------------------------------

 

(a)                                  Eurand and Anesta have the right to grant
all of the rights and licenses granted herein to Impax and neither is under any
obligation to any Third Party that conflicts with the terms of this Agreement.

 

(b)                                 Anesta owns and possesses all right, title
and interest in NDA 21-777.

 

6.6.                              Amendments in Writing

 

This Agreement may not be amended or modified except by a written agreement
signed by all parties.  No breach of any provision of this Agreement can be
waived unless in writing.  Waiver of any one breach shall not be deemed to be a
waiver of any other breach of the same or any other provision hereof.

 

6.7.                              Severability

 

In the event that any condition or covenant herein is held to be invalid or void
by any court of competent jurisdiction, the same shall be deemed severable from
the remainder of the Agreement, and shall in no way affect any other covenant or
condition contained herein.  If any condition or covenant of this Agreement is
deemed invalid or void due to its scope or breadth, such provision shall be
deemed valid to the extent permitted by law.

 

6.8.                              Governing Law

 

This Agreement is made pursuant to, and shall be governed by, the laws of the
State of Delaware without regard to Delaware’s conflict of laws principles.

 

6.9.                              Advice of Counsel

 

The parties hereto represent and declare that, in executing this Agreement, they
rely solely upon their own judgment, belief and knowledge, and the advice and
recommendations of their own independently selected counsel, concerning the
nature, extent and duration of their rights and claims, and they have not been
influenced to any extent whatsoever in executing the

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

25

--------------------------------------------------------------------------------

 

same by any representations or statements made or omitted to be made by the
other party hereto or by any person representing the other party.

 

6.10.                      Indemnification

 

(a)                                  Impax will indemnify, defend, and hold
Anesta and Eurand harmless against any actions, claims, liabilities and expenses
resulting from the manufacture, sale or use of the Impax ANDA Product sold by
Impax, its Affiliates or their customers (“Impax Indemnification Claims”). 
Impax’s indemnification obligations are conditioned upon prompt written
notification by Anesta and Eurand of any Impax Indemnification Claims and Anesta
and Eurand’s reasonable cooperation, at Impax’s expense, in Impax’s defense of
such claims.

 

(b)                                 Eurand will indemnify, defend and hold Impax
harmless against any actions, claims, liabilities and expenses resulting from
failure by Eurand to manufacture the Impax Authorized Generic Product in
accordance with this Agreement, except that this indemnification shall not apply
to personal injury claims caused by the actions or negligence of Impax (“Eurand
Indemnification Claims”).  Eurand’s indemnification obligations are conditioned
upon prompt written notification by Impax of any Eurand Indemnification Claims
and Impax’s reasonable cooperation, at Eurand’s expense, in Eurand’s defense of
such claims.

 

6.11.                      Termination and Effect of Termination

 

(a)                                  Term.  [**].

 

(b)                                 Termination.  This Agreement may be
terminated in the event that a party fails to perform or otherwise breaches any
material obligations hereunder.  Additionally, in the event that Impax breaches
paragraph 2.7 above, Anesta and Eurand shall have the right to terminate this
Agreement, although Impax’s agreements, and acknowledgements referenced in
paragraph 3.7 shall survive such termination.  Termination is effected by one
party giving notice to the

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

26

--------------------------------------------------------------------------------

 

other party in writing of its intent to terminate, while stating with
specificity the grounds therefore.  Unless otherwise provided herein, the party
so notified shall have sixty (60) days after receipt of the notice to cure the
breach or seek legal redress.  In no event shall such notice of intention to
terminate be deemed to waive any right to damages or any other remedy which the
party giving the notice may have as a consequence of such failure or such
breach.  Termination of this Agreement shall serve to terminate all licenses
granted hereunder.

 

6.12                         Dispute Resolution.

 

(a)                                  Preliminary Process.  If there is a
disagreement among the Parties as to the interpretation of this Agreement or in
relation to any aspect of the performance by either Party of its obligations
under this Agreement, the Parties shall, within ten (10) Business Days of
receipt of a written request from any Party, meet in good faith and try to
resolve the disagreement without recourse to legal proceedings.

 

(b)                                 Escalation of Dispute.  If resolution of the
disagreement does not occur within five (5) business days after such meeting,
the matter shall be escalated for determination by the President of Impax
Generics Division and Ross Oehler for Anesta and/or Manya Deehr for Eurand for
resolution, who may resolve the matter themselves or jointly appoint a mediator
or independent expert to do so.

 

(c)                                  Equitable Relief.  Nothing in this
Section 6.12 restricts any Party’s freedom to seek urgent relief to preserve a
legal right or remedy, or to protect a proprietary or trade secret right, or to
otherwise seek legal remedies through any available channel if resolution is not
otherwise achieved under this Section 6.12.

 

(d)                                 Section 3.7 Supersedes.  Nothing in this
Section 6.12 restricts Anesta and/or Eurand’s freedom to invoke the remedies of
Section 3.7 for sale by Impax of Licensed Product before the License Effective
Date.

 

6.13.                      Relationship of Parties

 

None of the parties or their agents and employees shall under any circumstance
be deemed an agent or representative of any other party, and none shall have
authority to act for and/or bind the other in any way, or represent that it is
in any way responsible for acts of the

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

27

--------------------------------------------------------------------------------

 

other.  This Agreement does not establish a joint venture, agency or partnership
between the parties.

 

6.14.                        Notice

 

Any notice required or permitted to be given by this Agreement shall be given by
postpaid first class certified mail, or overnight delivery service or by
facsimile with confirmation of receipt, addressed to:

 

In the case of Anesta and Eurand:

 

Anesta AG

Baarerstrasse 23

6300 Zug

Switzerland

 

With a copy to:

 

Anesta AG

Attn: Kevin Buchi

c/o Cephalon, Inc.

41 Moores Road

Frazer, PA 19355

USA

 

In the case of Impax:

 

Impax Laboratories, Inc.

30831 Huntwood Avenue

Hayward, CA 94544

Attention:  CEO

Facsimile:  (510) 972-7756

 

with copy to:

 

Legal Department

Impax Laboratories, Inc.

31047 Genstar Road

Hayward, CA 94544

Facsimile:  (510) 972-7756

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

28

--------------------------------------------------------------------------------

 

Such addresses may be altered by written notice.  If no time limit is specified
for a notice required or permitted to be given under this Agreement, the time
limit therefore shall be two (2) full business days, not including the day of
mailing.

 

6.15.                        Counterparts

 

This Agreement may be executed in any number of counterparts, each of which
shall be an original and all of which, taken together, shall constitute one and
the same instrument.

 

6.16                           Government Review

 

The Parties agree to submit this Agreement to the U.S. Federal Trade Commission
(“FTC”) and the U.S. Department of Justice (“DOJ”) as required by statute.

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

29

--------------------------------------------------------------------------------

 

IN WITNESS WHEREOF, the parties have by their duly authorized representatives
hereunder set their hands the day and year first above written.

 

 

DATED: October 7, 2010

ANESTA AG

 

On behalf of itself and its Affiliates,

 

 

 

 

 

By:

/s/ J. Kevin Buchi

 

Print Name: J. Kevin Buchi

 

Title: Chairman of the Board

 

 

DATED: October 8, 2010

EURAND, INC.

 

On behalf of itself and its Affiliates,

 

 

 

 

 

By:

/s/ John Framer

 

Print Name: John Framer

 

Title: President

 

 

 

 

DATED: October 7, 2010

IMPAX LABORATORIES, INC.

 

On behalf of itself and its Affiliates,

 

 

 

 

 

By:

/s/ Larry Hsu

 

Print Name: Larry Hsu

 

Title: Chief Executive Officer

 

--------------------------------------------------------------------------------

**          Portions of the Exhibit have been omitted and have been filed
separately pursuant to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

30

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