Exhibit 10.5

EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASSET TRANSFER AND LICENSE AGREEMENT

This ASSET TRANSFER AND LICENSE AGREEMENT (the “Agreement”) is dated as of
April 10, 2015 (the “Effective Date”) between Alkermes Pharma Ireland Limited, a
private limited company incorporated in Ireland (registered number 448848) whose
registered address is Connaught House, 1 Burlington Road, Dublin 4, Ireland
(“APIL”), and DV Technology LLC, a Delaware limited liability company whose
registered address is c/o Corporation Trust Center, 1209 Orange Street,
Wilmington, Delaware 19801, USA (“Purchaser,” and Purchaser shall include, after
the Effective Date, any entity possessing the obligations of Purchaser set forth
in this Agreement).

RECITALS:

WHEREAS, APIL desires to sell and assign to Purchaser, and Purchaser desires to
purchase and acquire from APIL, part of APIL’s controlled release drug
development business (the “Business”), comprising the Transferred IP and the
Transferred Agreements, and a license of the Nanotechnology IP, the OCR IP, the
Abuse Resistant Patents and the Licensed Trademarks, subject to the terms and
conditions set forth in this Agreement; and

NOW, THEREFORE, in consideration of the respective premises, mutual covenants
and agreements of the parties hereto, and other good and valuable consideration,
the receipt and sufficiency of which are acknowledged, the parties hereto agree
as follows:

1. Definitions.

Abuse Resistant Patents shall mean any patent application owned by APIL as of
the Effective Date and listed in Exhibit A-6 hereto (which for purposes of this
Agreement shall include certificates of invention and applications for such
certificates), together with any patents resulting therefrom, including any
divisionals, continuations, continuations-in-part, substitutions, reissues,
re-examinations, revalidations, extensions (including pediatric exclusivity
patent extensions), registrations, supplementary protection certificates,
renewals, and foreign equivalents of any such patents or patent applications.

Acorda Agreements shall mean (i) Amended and Restated License Agreement between
APIL and Acorda Therapeutics, Inc. dated September 26, 2003, as amended;
(ii) Supply Agreement between APIL and Acorda Therapeutics, Inc. dated
September 26, 2003, as amended; (iii) Development and Supplemental Agreement
dated January 14, 2011 to Amended and Restated License Agreement dated
September 26, 2003 between APIL and Acorda Therapeutics, Inc., as amended, and
Supply Agreement dated September 26, 2003 between APIL and Acorda Therapeutics,
Inc., as amended; and (iv) any related ancillary agreements between APIL and
Acorda Therapeutics, Inc. or its affiliates.

Affiliate shall mean, with respect to any Person, any other Person that
directly, or through one or more intermediaries, controls or is controlled by or
is under common control with such Person. For purposes of this Agreement,
“control” shall mean, as to any Person, the power to direct or cause the
direction of the management and policies of such Person, whether through the
ownership of voting securities, by contract or otherwise (and the terms
“controlled by” and “under common control with” shall have correlative
meanings). For purposes of Section 7 of this Agreement, APIL shall not be
treated as an Affiliate of Purchaser, and Purchaser shall not be treated as an
Affiliate of APIL.

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

BiDil Products shall mean BiDil XR™, a fixed dose combination of hydralazine
hydrochloride and isosorbide dinitrate, and any other pharmaceutical products
that may be licensed by APIL pursuant to the NitroMed Agreements.

Controlled shall mean with respect to any intellectual property, that APIL, in
whole or in part, owns or has a license to such intellectual property and has
the ability to grant a license or a sublicense, as applicable, or to otherwise
disclose proprietary or trade secret information, to Purchaser or its
sublicensees, without paying any consideration to any third party and without
either misappropriating the proprietary or trade secret information of a third
party or violating the terms of any agreement or other arrangement with any
third party existing and in effect at the time APIL would be required to grant
Purchaser or its sublicensees such license or sublicense.

Focalin Agreements shall mean: (i) Preliminary Development Agreement between
APIL and Novartis Pharma AG dated September 21, 2001; (ii) License and Supply
Agreement between APIL and Novartis Pharma AG dated December 17, 2004, as
amended; and (iii) any related ancillary agreements between APIL and Novartis
Pharma AG or its affiliates.

Focalin Products shall mean Focalin XR®, an extended-release oral formulation of
dexmethylphenidate, and any other pharmaceutical products that may be licensed
by APIL pursuant to the Focalin Agreements.

Know-How shall mean all proprietary data, information, knowledge, know-how,
inventions, discoveries, trade secrets, processes, techniques, strategies,
methods, practices, skills, experience, documents, apparatus, devices, assays,
screens, databases (including safety databases), database structures and data
analysis methods, compositions, materials, methods, formulas, improvements,
clinical and non-clinical study reports, test data including pharmacological,
biological, chemical, biochemical, toxicological, and clinical test data,
analytical and quality control data, stability data, studies and procedures.

Licensed Trademarks shall mean APIL’s trademarks (i) NanoCrystal®, (ii) SODAS®,
(iii) CODAS® and (iv) BeadTek™, application and registration details for which,
as of the Effective Date, are set out in Exhibit B-2 hereto.

Meloxicam IV/IM shall mean an aqueous extended-release formulation of the
selective COX-2 inhibitor non-steroidal anti-inflammatory drug meloxicam that
has been developed by APIL using NanoCrystal Technology, including an
intravenous or intramuscular form existing as of the Effective Date.

Meloxicam Parenteral Formulation shall mean a parenteral formulation of the
selective COX-2 inhibitor non-steroidal anti-inflammatory drug meloxicam
developed at any time on or after the Effective Date by or on behalf of
Purchaser using NanoCrystal Technology. For the avoidance of doubt, the
Meloxicam Parenteral Formulation shall not be deemed to include Meloxicam IV/IM.

Merck Agreement shall mean the Technology Transfer and License Agreement between
APIL and Merck & Co, Inc. dated July 26, 1999, as amended.

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

NanoCrystal Technology shall mean APIL’s proprietary technology comprising:

a. nanoparticulate dispersions of compounds stabilized against particle growth
or agglomeration, and materials, methods and equipment used for making such
dispersions; and

b. formulations, including finished formulations incorporating or derived from
such dispersions, and materials, methods and equipment used for making such
dispersions, provided such formulations, materials, methods and equipment are
for the maintenance and control of (i) nanoparticulate size of the
nanoparticulate component; (ii) redispersability of the nanoparticle
nanoparticulate component in biological fluids; (iii) the rate of release or
delivery of the nanoparticle nanoparticulate component in vivo; or (iv) the
anatomical site of release of the nanoparticle nanoparticulate component from
the finished dosage form of a pharmaceutical product.

Nanotechnology IP shall mean the Nanotechnology Know-How and the Nanotechnology
Patents.

Nanotechnology Know-How shall mean any Know-How Controlled by APIL as of the
Effective Date relating to Meloxicam IV/IM.

Nanotechnology Patents shall mean all patents and patent applications owned by
APIL as of the Effective Date and listed in Exhibit A-2 hereto (which for
purposes of this Agreement shall include certificates of invention and
applications for such certificates), together with any patents resulting
therefrom, including any divisionals, continuations, continuations-in-part,
substitutions, reissues, re-examinations, revalidations, extensions (including
pediatric exclusivity patent extensions), registrations, supplementary
protection certificates, renewals, and foreign equivalents of any such patents
or patent applications.

NitroMed Agreements shall mean (i) License Agreement between APIL and NitroMed,
Inc. dated February 9, 2007; and (ii) any related ancillary agreements between
APIL and NitroMed, Inc. or its affiliates.

OCR IP shall mean the OCR Know-How and the OCR Patents.

OCR Know-How shall mean any Know-How Controlled by APIL as of the Effective Date
relating to OCR Technology.

OCR Patents shall mean all patents and patent applications owned by APIL as of
the Effective Date and listed in Exhibit A-3 hereto, (which for purposes of this
Agreement shall include certificates of invention and applications for such
certificates), together with any patents resulting therefrom, including any
divisionals, continuations, continuations-in-part, substitutions, reissues,
re-examinations, revalidations, extensions (including pediatric exclusivity
patent extensions), registrations, supplementary protection certificates,
renewals, and foreign equivalents of any such patents or patent applications.

OCR Technology shall mean (i) APIL’s proprietary oral controlled release SODAS®
(Spheroidal Oral Drug Absorption System) technology comprising a
multiparticulate drug delivery system based on the production of
controlled-release beads typically of approximately 1 to 2 mm in diameter
containing drug plus excipients coated with product-specific modified-release
polymers to achieve varying degrees of modified release depending upon the
required release profile for any particular product; control of drug release may
be a result of the use of pH-dependent or independent coatings and a single
polymer system or a combination of polymers. Once produced, the coated beads are
formulated into the final dosage form;

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

and (ii) APIL’s formulation technology based on the production of a population
of coated beads containing a gelling agent plus excipients. These gelling
agent-containing beads are designed for abuse deterrent formulations and do not
contain any drug. OCR Technology excludes APIL Know-How relating to alcohol dose
dumping.

Paladin Agreements shall mean (i) License and Distribution Agreement between
APIL and Paladin Labs Inc. dated May 12, 2011; and (ii) any related ancillary
agreements between APIL and Paladin Labs Inc. or its affiliates.

Paladin Patents shall mean all patents and patent applications licensed by APIL
to Paladin as of the Effective Date pursuant to the Paladin Agreements,
including those listed in Exhibit A-5 hereto.

Paladin Products shall mean any pharmaceutical products that may be licensed by
APIL pursuant to the Paladin Agreements.

Person shall mean a person, corporation, partnership, limited liability company,
joint venture, trust or other entity or organization.

Ritalin Agreements shall mean (i) Development, License and Supply Agreement
between APIL and Novartis Pharmaceuticals Corporation dated December 17, 1997,
as amended; and (ii) any related ancillary agreements between APIL and Novartis
Pharmaceuticals Corporation or its affiliates.

Ritalin Products shall mean Ritalin SR®, a sustained-release oral formulation of
methylphenidate, and any other pharmaceutical products that may be licensed by
APIL pursuant to the Ritalin Agreements.

Transferred Agreements shall mean: (i) the Focalin Agreements; (ii) the Ritalin
Agreements; (iii) the Paladin Agreements; (iv) the Verapamil Agreements; (v) the
Zogenix Agreements; (vi) the NitroMed Agreements; and (vii) the Transferred
License and Settlement Agreements.

Transferred IP shall mean (i) the Transferred Patents and (ii) the Transferred
Trademarks, in each case, together with: (a) the right to claim priority under
the Paris Convention and any other similar provision of national or
international law, (b) the right to sue and recover damages or other
compensation or equitable relief for past, present or future infringement,
misappropriation or violation thereof, and (c) the right to fully and entirely
stand in the place of APIL in all matters related thereto.

Transferred License and Settlement Agreements shall mean those License
Agreements and Settlement Agreements as listed in Exhibit C hereto.

Transferred Patents shall mean (i) the Paladin Patents, (ii) the Zogenix
Patents; and (iii) all patents and patent applications owned by APIL as of the
Effective Date and listed in Exhibit A-1 hereto (the patents and patent
applications listed in subsections A-1.5, A-1.6 and A-1.7 of Exhibit A-1 being
described as the “Grant-Back Patents”) (which for purposes of this Agreement
shall include for the patents and patent applications described in each of
clauses (i), (ii), and (iii), the certificates of invention and applications for
such certificates), together with (for the patents and patent applications
described in each of clauses (i), (ii) and (iii)) any patents resulting
therefrom, including any divisionals, continuations, continuations-in-part,
substitutions, reissues, re-examinations, revalidations, extensions (including
pediatric exclusivity patent extensions), registrations, supplementary
protection certificates, renewals, and foreign equivalents of any such patents
or patent applications.

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Transferred Trademarks shall mean the Verelan trademark owned by APIL used with
respect to Verapamil Products as of the Effective Date, related registrations as
listed in Exhibit B-1 hereto, and the goodwill associated therewith.

Verapamil Agreements shall mean (i) License and Supply Agreement between APIL
and Kremers Urban Pharmaceuticals, Inc. dated January 1, 2014; (ii) Amended and
Restated License and Supply Agreement between APIL and Watson Laboratories, Inc.
dated June 26, 2003, as amended; and (iii) any related ancillary agreements
between APIL and either Kremers Urban Pharmaceuticals, Inc. or its affiliates or
Watson Laboratories, Inc. or its affiliates.

Verapamil Products shall mean any sustained-release oral formulations of
verapamil hydrochloride and any other pharmaceutical products that may be
licensed by APIL pursuant to the Verapamil Agreements.

Zanaflex Agreements shall mean (i) Asset Purchase Agreement between APIL and
Acorda Therapeutics, Inc. dated July 21, 2004; (ii) Supply Agreement between
APIL and Acorda Therapeutics, Inc. dated July 21, 2004; and (iii) any related
ancillary agreements between APIL and Zogenix, Inc. or its affiliates.

Zogenix Agreements shall mean: (i) License Agreement between APIL and Zogenix,
Inc. dated November 27, 2007, as amended; (ii) Development and Clinical Supply
Agreement between APIL and Zogenix, Inc. dated December 20, 2007;
(iii) Commercial Manufacturing and Supply Agreement between APIL and Zogenix,
Inc. dated November 2, 2012; and (iv) Second Generation (ZX004) Commercial
Manufacturing and Supply Agreement between Daravita Limited and Zogenix, Inc.
dated March 5, 2015 (v) any related ancillary agreements between APIL and
Zogenix, Inc. or its affiliates.

Zogenix Patents shall mean all patents and patent applications licensed by APIL
to Zogenix as of the Effective Date pursuant to the Zogenix Agreements,
including those listed in Exhibit A-4 hereto.

Zogenix Products shall mean Zohydro™ ER, an extended-release oral formulation of
hydrocodone bitartrate, and any other pharmaceutical products that may be
licensed by APIL pursuant to the Zogenix Agreements.

2. Transfer of Transferred IP.

a. Transferred IP. Subject to the terms and conditions of this Agreement,
effective the Effective Date, APIL hereby sells, assigns, transfers, conveys and
delivers to Purchaser, and Purchaser hereby purchases, acquires and accepts from
APIL, all of APIL’s right, title and interest on the Effective Date throughout
the world in and to the Transferred IP.

b. Licenses Back of Paladin Patents and Zogenix Patents. Subject to the terms
and conditions of this Agreement, effective the Effective Date, Purchaser hereby
grants APIL a non-exclusive, worldwide license under the Grant-Back Patents, the
Paladin Patents and the Zogenix Patents, with the right to sublicense, to
develop, make, have made, use, sell, offer to sell and import pharmaceutical
products for the treatment of any human disease, disorder or condition, subject
to the Paladin Agreements, the Zogenix Agreements, the Focalin Agreements and
the Ritalin Agreements. Subject to the terms and conditions of this Agreement,
Purchaser hereby also grants APIL an exclusive, worldwide license under the
Grant-Back Patents, the Paladin Patents and the Zogenix Patents, with the right
to sublicense, to develop, make, have made, use, sell, offer to sell and import
any pharmaceutical products licensed, supplied or developed under

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

the Acorda Agreements. Notwithstanding anything to the contrary contained in
this Agreement, the parties hereby agree that all of the licenses granted by
Purchaser to APIL under this Section 2(b) shall extend until the expiration or
invalidation of all Grant-Back Patents, Paladin Patents and Zogenix Patents.

c. Transfer of Transferred Patents. After the Effective Date, APIL shall
execute, or procure the execution of, such formal documents of sale and/or
assignment as are required consistent with the terms and conditions of this
Agreement to formally record the change of title to the Transferred Patents to
Purchaser in a timely manner.

d. Transfer of Transferred Trademarks. After the Effective Date, APIL shall
execute, or procure the execution of, such formal documents of sale and/or
assignment as are required consistent with the terms and conditions of this
Agreement to formally record the change of title to the Transferred Trademarks
to Purchaser in a timely manner.

e. Prosecution and Enforcement. Purchaser shall have the right to file,
prosecute (including any oppositions, appeals, prosecution before the U.S.
Patent Office and Patent Trial and Appeal Board, as well as post-grant
procedures such as, for example, interference proceedings, Inter Partes Review,
Post Grant Review, re-examination, reissue, and derivation procedures) and
maintain (“Prosecute”) and defend and enforce (“Enforce,” and collectively,
“Prosecute and Enforce”) the Transferred Patents at its sole discretion and cost
and expense. Purchaser shall keep APIL reasonably informed of activities
undertaken to Prosecute and Enforce the Transferred Patents and provide APIL
with copies of material correspondence and filings relating to activities
undertaken to Prosecute and Enforce the Transferred Patents.

3. License.

a. Nanotechnology License. Subject to the terms and conditions of this
Agreement, effective the Effective Date, APIL hereby grants Purchaser an
exclusive, worldwide license under the Nanotechnology IP, with the right to
sublicense, to develop, make, have made, use, sell, offer to sell and import
Meloxicam IV/IM and Meloxicam Parenteral Formulation for the treatment of any
human disease, disorder or condition, subject to the Merck Agreement.
Notwithstanding anything to the contrary contained in this Agreement, the
parties hereby agree that all of the licenses and rights granted by APIL to
Purchaser under this Section 3(a) shall be perpetual, unless terminated pursuant
to the provisions of Exhibit D hereto.

b. OCR Licenses. Subject to the terms and conditions of this Agreement, the
Acorda Agreements and the Zanaflex Agreements, effective the Effective Date,
APIL hereby grants Purchaser a non-exclusive, worldwide license under the OCR
IP, with the right to sublicense, to develop, make, have made, use, sell, offer
to sell and import pharmaceutical products for the treatment of any human
disease, disorder or condition. Subject to the terms and conditions of this
Agreement, effective the Effective Date, APIL hereby also grants Purchaser an
exclusive, worldwide license under the OCR IP, with the right to sublicense, to
develop, make, have made, use, sell, offer to sell and import the BiDil
Products, the Focalin Products, the Ritalin Products, the Paladin Products, the
Verapamil Products and the Zogenix Products. Notwithstanding anything to the
contrary contained in this Agreement, the parties hereby agree that all of the
licenses and rights granted by APIL to Purchaser under this Section 3(b) shall
be perpetual, unless terminated pursuant to the provisions of Exhibit D hereto.

c. Abuse Resistant Patents License. Subject to the terms and conditions of this
Agreement, effective the Effective Date, APIL hereby grants Purchaser an
exclusive, worldwide license under the

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Abuse Resistant Patents, with the right to sublicense, to develop, make, have
made, use, sell, offer to sell and import the Paladin Products and the Zogenix
Products. Notwithstanding anything to the contrary contained in this Agreement,
the parties hereby agree that all of the licenses granted by APIL to Purchaser
under this Section 3(c) shall extend until the expiration or invalidation of all
Abuse Resistant Patents.

d. Delivery of Licensed Know-How. Promptly following the Effective Date, APIL
shall make available to Purchaser the Nanotechnology Know-How and the OCR
Know-How in an orderly fashion and in a manner such that the value of such
Know-How is preserved in all material respects.

e. Trademark License. Subject to the terms and conditions of this Agreement,
effective the Effective Date, APIL hereby grants Purchaser a non-exclusive,
worldwide license to use the Licensed Trademarks for the advertising, promotion,
marketing, distribution and sale of pharmaceutical products covered by the
licenses granted in Sections 3(a), (b) and (c) hereof. Purchaser shall have the
right to grant sublicenses under the foregoing non-exclusive license to its
sublicensees under Sections 3(a), (b) and (c) hereof, subject to the provisions
of this Section 3(e). Purchaser hereby acknowledges APIL’s exclusive right,
title and interest in and to the Licensed Trademarks and agrees that Purchaser
and its sublicensees will not at any time do, or cause to be done, any act or
thing contesting or in any way intending to impair the validity of and/or APIL’s
exclusive right, title and interest in and to the Licensed Trademarks. Purchaser
and its sublicensees will not in any manner represent that they own the Licensed
Trademarks, and Purchaser hereby acknowledges that use of the Licensed
Trademarks as set forth in this Section 3(e) shall not create any rights, title
or interest in or to the Licensed Trademarks in favor of Purchaser or its
sublicensees, but that all use of the Licensed Trademarks by Purchaser and its
sublicensees shall inure to the benefit of APIL. Purchaser shall submit to APIL
for its review and approval samples of any proposed use of the Licensed
Trademarks at least fifteen (15) days prior to such use by Purchaser. APIL shall
review any proposed use of the Licensed Trademarks within fifteen (15) days of
Purchaser’s written request, and if APIL does not either approve or decline to
approve such use within such 15-day period, such use shall be automatically
deemed approved. Any such approval shall be deemed to be approval of the same or
similar uses of the Licensed Trademarks thereafter. APIL shall not unreasonably
withhold, delay or condition any such approval request by Purchaser.

f. Prosecution. APIL shall have the right to Prosecute any issued patent or
pending patent application within the Nanotechnology Patents, the OCR Patents,
and the Abuse Resistant Patents at its sole discretion and cost and expense.
APIL shall keep Purchaser reasonably informed of all activities during the
course of such prosecution and provide Purchaser with copies of material
correspondence and filings relating to such activities. At APIL’s request and
expense, Purchaser will cooperate to Prosecute the Nanotechnology Patents, the
OCR Patents and the Abuse Resistant Patents. Without prejudice to the generality
of the foregoing sentence, Purchaser shall keep APIL reasonably informed from
time-to-time of activities relating to Zogenix Products that are encompassed by
the Abuse Resistant Patents and shall reasonably allow APIL to use data and
information generated by Purchaser relating to such Zogenix Products to
Prosecute the Abuse Resistant Patents.

If in addition to APIL’s activities to Prosecute the Abuse Resistant Patents and
the Nanotechnology Patents, Purchaser wishes with respect to any Abuse Resistant
Patent or any Nanotechnology Patent listed in subsection A-2.6 of Exhibit A-1 to
have a divisional, continuation or continuation-in-part application filed that
solely claims a compound, composition, method of making or method of using
compounds or compositions within the scope of Purchaser’s exclusive license
hereunder, then Purchaser shall notify APIL and, subject to APIL’s approval,
which shall not unreasonably withheld, delayed or conditioned, APIL will use
commercially reasonable efforts to Prosecute such patent application, at
Purchaser’s cost

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

and expense. Promptly upon receipt, APIL will provide Purchaser with all patent
office documents relating to such prosecution, and will also provide drafts of
responses to office actions and other substantive filings with any patent office
regarding such patent application sufficiently in advance of their submission to
enable review and comment by Purchaser. APIL will consider in good faith all
comments timely made by Purchaser.

g. Enforcement. APIL shall have the first right to Enforce any issued patent
within the Nanotechnology Patents, the OCR Patents, or the Abuse Resistant
Patents. To the extent necessary, Purchaser will cooperate with APIL, at APIL’s
cost and expense, to carry out such enforcement, including joining as a party.
All costs and expenses of such enforcement action will be borne by APIL, and
APIL shall retain any recovery from such an enforcement action. Notwithstanding
the foregoing, Purchaser may voluntarily join such enforcement action if the
action pertains to an Infringing Activity (as defined below), subject to APIL’s
right to control such action. Where Purchaser so joins such an enforcement
action, Purchaser and APIL will share all costs and expenses thereof equally and
will also share any recovery from such action equally. APIL shall not enter into
any settlement agreement that would materially harm Purchaser’s rights pursuant
to this Agreement without Purchaser’s prior written consent, which shall not be
unreasonably withheld, delayed or conditioned. Both APIL and Purchaser shall
promptly notify the other party, as applicable, of any infringing activity of
which they are aware with respect to any of the Nanotechnology Patents, OCR
Patents, and/or Abuse Resistant Patents within the scope of an exclusive license
granted to Purchaser pursuant to this Agreement to the Meloxicam Parenteral
Formulation, Meloxicam IV/IM, the BiDil Products, the Focalin Products, the
Ritalin Products, the Paladin Products, the Verapamil Products or the Zogenix
Products (an “Infringing Activity”).

To the extent that APIL declines to Enforce any such issued patent within the
Nanotechnology Patents, the OCR Patents, or the Abuse Resistant Patents with
respect to an Infringing Activity, Purchaser shall have the option to Enforce
such patent, at its own cost and expense, provided that Purchaser can
demonstrate to APIL’s reasonable satisfaction that (i) Purchaser is
contractually obligated under a Transferred Agreement to Enforce, or to allow
the counterparty to such Transferred Agreement to Enforce, such patent with
respect to such Infringing Activity or (ii) (A) permitting the Infringing
Activity would have a materially adverse effect on Purchaser’s and its
sublicensees’ sales of the product exclusively licensed under such patent, and
(B) based on a due care determination, including obtaining competent legal
advice, the Infringing Activity exists. In such cases, Purchaser will have sole
control of such enforcement at its cost and expense. To the extent necessary,
APIL will cooperate with Purchaser, at Purchaser’s cost and expense, to carry
out such enforcement, including joining as a party. APIL shall also have the
right, at its option and its cost and expense, to join in any such enforcement
action taken by Purchaser, subject to Purchaser’s right to control such action.
Any recovery from an enforcement action involving a patent within the Abuse
Resistant Patents shall belong solely to Purchaser. For any recovery from an
enforcement action involving a patent within the Nanotechnology Patents or OCR
Patents, APIL shall be entitled to fifty percent (50%) of such recovery,
provided however, that fifty percent (50%) of the legal fees, costs and expenses
of such enforcement action incurred by Purchaser shall be deducted from APIL’s
portion of the recovery. Purchaser shall not enter into any settlement agreement
regarding the Nanotechnology Patents, OCR Patents, or Abuse Resistant Patents
without APIL’s prior written consent which shall not be unreasonably withheld,
delayed or conditioned.

The Parties agree that with respect to Purchaser’s obligations to Zogenix, Inc.
under the Zogenix Agreements the Abuse Resistant Patents shall be deemed to be
“Elan Patents” (pursuant to clause (d) of the definition of Elan Patents under
the License Agreement between APIL and Zogenix, Inc. dated November 27, 2007, as
amended).

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4. Transferred Agreements. Subject to the terms and conditions of this
Agreement, effective the Effective Date, APIL hereby assigns to Purchaser APIL’s
rights, and Purchaser hereby assumes APIL’s obligations, under the Transferred
Agreements, if such Transferred Agreements are assignable at such time, except
to the extent such rights and obligations relate to performance or
non-performance under the Transferred Agreements on or prior to the Effective
Date. On the Effective Date and thereafter from time to time until all
Transferred Agreements are assigned, APIL shall transfer to Purchaser copies of
the Transferred Agreements and such information in APIL’s possession as is
reasonably necessary to continue conducting business under such Transferred
Agreements. If any Transferred Agreement is not assignable as of the Effective
Date, APIL shall use commercially reasonable efforts to seek the consent of the
applicable third party(ies) to assign such Transferred Agreement to Purchaser
and, if and when such consent(s) are obtained, Purchaser shall be assigned
APIL’s rights and shall assume APIL’s obligations under such Transferred
Agreement, except to the extent such rights and obligations relate to
performance or non-performance under the Transferred Agreement on or prior to
the Effective Date. To the extent permitted by applicable law and by the terms
of the applicable Transferred Agreement, any Transferred Agreement that is not
assignable to Purchaser as of the Effective Date shall be held, as of and from
the Effective Date, by APIL for the benefit and burden of Purchaser and the
covenants and obligations thereunder shall be fully performed by Purchaser on
APIL’s behalf and all rights, liabilities and obligations existing thereunder,
as of and from the Effective Date, shall be for Purchaser’s account. To the
extent permitted by applicable law and by the terms of the applicable
Transferred Agreement, APIL shall take or cause to be taken, at Purchaser’s
expense, such actions as Purchaser may reasonably request which are required to
be taken in order to provide Purchaser with the benefits and burdens of the
Transferred Agreements that are not assignable as of the Effective Date. From
and after the Effective Date, without Purchaser’s prior consent, and subject to
Purchaser’s compliance with APIL’s obligations under the applicable Transferred
Agreement that are not assignable as of the Effective Date, APIL shall not take,
permit to be taken or omit to take any action, in each case, within APIL’s
reasonable control, which would give the counterparty to such Transferred
Agreement the right to terminate such Transferred Agreement or which would alter
any of APIL’s rights or obligations under such Transferred Agreement in a manner
that would materially adversely affect Purchaser’s rights and benefits under
this Agreement. In the event Purchaser fails to substantially comply with APIL’s
obligations under a Transferred Agreement that is not assignable as of the
Effective Date or the counterparty to such Transferred Agreement gives notice of
a breach or default under such Transferred Agreement in connection with
Purchaser’s failure to comply with APIL’s obligations under such Transferred
Agreement, then APIL shall have the right to take action to terminate such
Agreement. APIL shall promptly pay over to Purchaser the amount of all payments
received by it in respect of all such Transferred Agreements not assigned as of
the Effective Date, to the extent such payments relate to performance after the
Effective Date, net of any costs and expenses of APIL related to providing
Purchaser with the benefits and burdens of such Transferred Agreements and net
of any taxes incurred by APIL related to the provision of such benefits and
burdens to Purchaser and the receipt of payments under such Transferred
Agreements.

5. Consideration. In consideration of APIL’s transfer of the Transferred IP and
Transferred Agreements to Purchaser in accordance with Sections 2 and 4 hereof
and the grant by APIL of the licenses to Purchaser in accordance with Section 3
hereof, Purchaser shall upon execution of this Agreement pay to APIL (a) [* * *]
US Dollars (US$[* * *]) in cash plus (b) the Earn-Out Consideration as described
in Exhibit D hereto. The cash consideration allocable to any Irish patents
forming part of the Transferred IP will amount to €[* * *]. All consideration
will be paid subject to any withholding or deduction required by law. No portion
of the Earn-Out Consideration as described in Exhibit D hereto will be paid in
respect of the user of an Irish patent. To the extent that any of the
Transferred Agreements constitute Irish situated property which is not exempt
from stamp duty under section 101 of the Stamp Duties Consolidation Act, 1999,
no consideration is allocated to such Transferred Agreement.

 

9

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6. Warranties. APIL hereby represents and warrants to Purchaser as of the
Effective Date as follows:

(a) Corporate Existence and Power. APIL is a corporation duly organized and
validly existing under the laws of Ireland, and has all requisite power and
authority to own and operate its properties and to carry on its business as now
conducted.

(b) Authority and Binding Agreement. APIL has the corporate power and authority
to enter into this Agreement and perform its obligations hereunder. APIL has
taken all necessary corporate action on its part required to authorize the
execution and delivery of the Agreement and the performance of its obligations
hereunder. The Agreement has been duly executed and delivered by APIL and
constitutes a legal, valid and binding obligation of APIL that is enforceable
against it in accordance with its terms; except as enforceability may be limited
by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and
other laws relating to or affecting creditors’ rights generally and by general
equitable principles and public policy constraints (including those pertaining
to limitations and/or exclusions of liability, competition law, penalties and
jurisdictional issues including conflicts of law).

(c) No Conflict. The execution, delivery and performance of this Agreement by
APIL does not conflict with, and would not result in a breach or violation of or
constitute a default under (i) any material agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound; (ii) the provisions of its charter or operative documents or bylaws; or
(iii) any material applicable law, or any judgment, decree or order of any
court, governmental body or administrative or other agency having jurisdiction
over it.

7. Non-Compete. During the period beginning on the Effective Date and ending [*
* *] (the “Non-Compete Period”), except for ownership of the equity in Recro
Pharma, Inc. issued pursuant to the warrant described in the Purchase and Sale
Agreement dated March 7, 2015 by and among, APIL, Daravita Limited, Eagle
Holdings USA, Inc., Recro Pharma LLC, and Recro Pharma, Inc. (the “Purchase
Agreement”), APIL and its Affiliates agree not to directly or indirectly engage
in, or have an ownership interest in, any business or enterprise (or subsidiary
or division thereof) that engages in the development, license, manufacture,
testing, packaging, storage, sale and shipment of Meloxicam IV/IM or Meloxicam
Parenteral Formulation, or the underlying molecules or salts thereof in
combination with the Nanotechnology IP covering such products (a “Competing
Business”). If APIL and/or its Affiliates are directly or indirectly acquired by
(whether by merger, acquisition of assets or equity, or otherwise), or directly
or indirectly acquire (whether by merger, acquisition of assets or equity, or
otherwise), a third party which engages in a Competing Business, such third
party and its Affiliates (other than APIL and/or its Affiliates existing prior
to the date of such acquisition) shall not be restricted from continuing to
engage in such Competing Business pursuant to this Section 7, provided that the
rights of such third party and its Affiliates to utilize the Nanotechnology IP
in such Competing Business existed prior to the date of such acquisition.

(b) Each party acknowledges and agrees that the provisions of this Section 7 are
reasonable and necessary to protect the legitimate business interests of the
other party, including without limitation such party’s confidential information
and goodwill. Each party agrees, and shall not contest, that the other party’s
remedies at law for any breach or threat of breach by such party or its
Affiliates of the provisions of this Section 7 will be inadequate, and that the
other party shall be entitled to an injunction or injunctions to prevent
breaches of the provisions of this Section 7

 

10

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

and to enforce specifically such terms and provisions, in addition to any other
remedy to which the other party may be entitled at law or in equity. The
restrictive covenants contained in this Section 7 are covenants independent of
any other provision of this Agreement or other agreement between the parties and
the existence of any claim which a party may allege against another party under
any provision of this Agreement, any other agreement, or otherwise will not
prevent the enforcement of the covenants in this Section 7. If any of the
provisions contained in this Section 7 shall for any reason be held to be
excessively broad as to duration, scope, activity or subject, then such
provision shall be construed by limited and reducing it, so as to be valid and
enforceable to the extent compatible with applicable law or the determination by
a court of competent jurisdiction. The parties agree and intend that a party’s
obligations under this Section 7 will be tolled during any period that such
party is found to be in breach of any of the obligations under this Section 7,
so that the other party is provided with the full benefit of the restrictive
periods set forth herein.

8. Disclaimer. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES IN SECTION 6 OF
THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES IN THIS
AGREEMENT, EXPRESS OR IMPLIED, REGARDING THE SUBJECT MATTER OF THIS AGREEMENT.
WITHOUT LIMITING THE FOREGOING, EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES IN
SECTION 6 OF THIS AGREEMENT, APIL MAKES NO REPRESENTATION, GUARANTY OR WARRANTY
IN THIS AGREEMENT REGARDING THE TRANSFERRED IP, TRANSFERRED AGREEMENTS,
NANOTECHNOLOGY IP, OCR IP, ABUSE RESISTANT PATENTS AND LICENSED TRADEMARKS,
INCLUDING, WITHOUT LIMITATION, AS TO THE CONDITION OF TITLE, ENFORCEABILITY,
SUITABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, MERCHANTABILITY, VALIDITY,
REGISTRABILITY, NON-INFRINGEMENT OR ANY OTHER WARRANTY, WHETHER EXPRESS OR
IMPLIED OR BY OPERATION OF LAW.

9. Further Assurances. APIL shall use reasonable efforts to take actions and
execute and deliver documents that Purchaser may reasonably request to effect
the terms of this Agreement, to perfect Purchaser’s title in and to the
Transferred IP and to assign the Transferred Agreements.

10. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware, without giving effect to any
principles, statutory provisions or other rules of choice of law that would
require the application of the laws of a different state or country.

11. Entire Agreement; Modification. This Agreement sets forth the entire
agreement and understanding between the parties as to the subject matter hereof
and thereof and supersedes all prior and contemporaneous negotiations,
agreements, representations, understandings and commitments between the parties
with respect thereto. There shall be no amendments or modifications to this
Agreement, except by a written document referencing this Agreement which is
signed by both parties.

12. Counterparts. This Agreement may be executed in one or more counterparts,
all of which shall be considered one and the same agreement.

[SIGNATURE PAGE FOLLOWS]

 

11

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

IN WITNESS WHEREOF, each of the parties hereto has caused its duly authorized
representative to execute this Agreement as of the date first set forth above.

 

ALKERMES PHARMA IRELAND LIMITED By

/s/

Name: Title: DV TECHNOLOGY LLC By

/s/

Name: Title:

 

12

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-1

Transferred Patents

A-1.1 “Reduction of Intravenously Administered
Nanoparticulate-Formulation-Induced Adverse Physiological Reactions”

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry

Date

01.0056.US   ORD   United States   08/696,754   14 Aug 1996   Granted  
5,834,025   14 Aug 2016 01.0056.US   REI   United States   12/027,100  
06-Feb-2008   Granted   RE41,884 E   14-Aug-2016 03.0056.CA   PCT   Canada  
2232879   25-Sep-1996   Granted   2232879   25-Sep-2016 03.0056.EP   DIV *  
European Patent Convention   2010181619.7   29-Sep-2010   Pending   2 275 094 A
  25-Sep-2016

 

* Divisional from EP 96932321.1 (EP 0 859 604)

A-1.2 “Nanoparticulate Compositions Having Lysozyme as a Surface Stabilizer”

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry

Date

01.0083.US   ORD   United States   10/357,514   04-Feb-2003   Granted   7459283
  10-Jul-2026 01.0083.US   CON   United States   12/292,091   12-Nov-2008  
Granted   8323641   04-Feb-2023 01.0083.US   CON   United States   13/693,858  
04-Dec-2012   Granted   8652464   12-Nov-2028   CON   United States   14/182,097
  17-Feb-2014   Pending     03.0083.AT   PCT   Austria   EP Validation  
04-Feb-2003   Granted   1 471 887   04-Feb-2023 03.0083.BE   PCT   Belgium  
EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023 03.0083.BG   PCT
  Bulgaria   EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023
03.0083.CA   PCT   Canada   2475092   04-Feb-2003   Granted   2475092  
04-Feb-2023 03.0083.CZ   PCT   Czech Republic   EP Validation   04-Feb-2003  
Granted   1 471 887   04-Feb-2023 03.0083.DK   PCT   Denmark   EP Validation  
04-Feb-2003   Granted   1 471 887   04-Feb-2023

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

EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry

Date

03.0083.EP   EPC   European Patent Convention   03737537.5   04-Feb-2003  
Granted   1 471 887   03.0083.FI   PCT   Finland   EP Validation   04-Feb-2003  
Granted   1 471 887   04-Feb-2023 03.0083.FR   PCT   France   EP Validation  
04-Feb-2003   Granted   1 471 887   04-Feb-2023 03.0083.DE   PCT   Germany  
EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023 03.0083.GR   PCT
  Greece   EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023
03.0083.HU   PCT   Hungary   EP Validation   04-Feb-2003   Granted   E008527  
04-Feb-2023 03.0083.IE   PCT   Ireland   EP Validation   04-Feb-2003   Granted  
1 471 887   04-Feb-2023 03.0083.IT   PCT   Italy   EP Validation   04-Feb-2003  
Granted   1 471 887   04-Feb-2023 03.0083.JP   PCT   Japan   2003-565446  
04-Feb-2003   Granted   4598399   04-Feb-2023 03.0083.NL   PCT   Netherlands  
EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023 03.0083.PT   PCT
  Portugal   EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023
03.0083.SK   PCT   Slovakia   EP Validation   04-Feb-2003   Granted   1 471 887
  04-Feb-2023 03.0083.ES   PCT   Spain   EP Validation   04-Feb-2003   Granted  
1 471 887   04-Feb-2023 03.0083.SE   PCT   Sweden   EP Validation   04-Feb-2003
  Granted   1 471 887   04-Feb-2023 03.0083.CH/LI   PCT   Switzerland /
Liechtenstein   EP Validation   04-Feb-2003   Granted   1 471 887   04-Feb-2023
03.0083.GB   PCT   United Kingdom   EP Validation   04-Feb-2003   Granted   1
471 887   04-Feb-2023

A-1.3 “Nanoparticulate Meloxicam Formulations”

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry

Date

01.0099.US   ORD   US   10/784,900   24-Feb-2004   Granted   8512727  
25-Dec-2022 01.0099.US   CON   US   13/941,076   12-Jul-2013   Pending    
03.0099.BE   PCT   Belgium   EP Validation   24-Feb-2004   Granted   1 617 816  
24-Feb-2024 03.0099.CA   PCT   Canada   2517679   24-Feb-2004   Allowed  
2517679   24-Feb-2024 03.0099.EP   PCT   European Patent Convention   04785761.0
  24-Feb-2004   Granted   1 617 816   24-Feb-2024 03.0099.EP   DIV  
European Patent Convention   08006465.2     Pending   1 938 803 A   24-Feb-2024

 

14

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry

Date

03.0099.FR   PCT   France   EP Validation   24-Feb-2004   Granted   1 617 816  
24-Feb-2024 03.0099.DE   PCT   Germany   EP Validation   24-Feb-2004   Granted  
1 617 816   24-Feb-2024 03.0099.HU   PCT   Hungary   EP Validation   24-Feb-2004
  Granted   E005977   24-Feb-2024 03.0099.IE   PCT   Ireland   EP Validation  
24-Feb-2004   Granted   1 617 816   24-Feb-2024 03.0099.IT   PCT   Italy  
EP Validation   24-Feb-2004   Granted   1 617 816   24-Feb-2024 03.0099.JP   PCT
  Japan   2006-532300   27-Feb-2004   Granted   4891774   27-Feb-2024 03.0099.JP
  DIV   Japan   2010-233858   27-Feb-2004   Granted   5548092   27-Feb-2024
03.0099.ES   PCT   Spain   EP Validation   24-Feb-2004   Granted   1 617 816  
24-Feb-2024 03.0099.CH/LI   PCT   Switzerland / Liechtenstein   EP Validation  
24-Feb-2004   Granted   1 617 816   24-Feb-2024 03.0099.GB   PCT  
United Kingdom   EP Validation   24-Feb-2004   Granted   1 617 816   24-Feb-2024

A-1.4 “Controlled Release Compositions Comprising a Combination of Isosorbide
Dinitrate and Hydralazine Hydrochloride”

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /
Publication No.

 

Normal Expiry

Date

02.1007.US   CON   United States   13/606,915   7-Sep-2012   Granted   8,992,973
  02.1007.US   CON2   United States   14/638,984   04-Mar-2015   Pending   —    
04.1007.CA   ORD   Canada   2627951   26-Oct-2006   Pending   2627951 A  
26-Oct-2026 04.1007.EP   ORD   European Patent Convention   20060826638  
26-Oct-2006   Pending   1 951 210 A   26-Oct-2026

 

15

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

A-1.5 “Multiparticulate Modified Release Composition”

 

APIL Ref.

  

Case Type

  

Country

  

Application No.

  

Filing Date

  

Status

  

Patent /
Publication No.

  

Normal Expiry
Date

02.1816E.US

   CON2    United States    09/850,425    07-May-2001    Granted    6730325   
1-Nov-2019

02.1816E.US

   CON4    United States    10/354,483    30-Jan-2003    Granted    6793936   
1-Nov-2019

02.1816E.US

   CON5    United States    10/827,689    19-Apr-2004    Pending    2004-0197405
   1-Nov-2019

A-1.6 Case Number: 05.0082.US

Invention Title: COMPOSITIONS HAVING A COMBINATION OF IMMEDIATE RELEASE AND
CONTROLLED RELEASE CHARACTERISTICS

 

Country

 

Sub Case

 

Case Type

 

Status

 

Application Number

 

Filing Date

 

Patent Number

 

Issue Date

 

Expiration Date

United States of America   2   ORD   Granted   10/268,928   11-Oct-2002  
6,908,626   21-Jun-2005   25-Dec-2022

A-1.7 Case Number: 06.0082.

Invention Title: COMPOSITIONS HAVING A COMBINATION OF IMMEDIATE RELEASE AND
CONTROLLED RELEASE CHARACTERISTICS

 

Country   Sub Case   Case Type   Status   Application Number   Filing Date  
Patent Number   Issue Date   Expiration Date Austria     EPC   Granted  
02800993.4   11-Oct-2002   EP 1 443 912   29-Aug-2007   11-Oct-2022 Belgium    
EPC   Granted   02800993.4   11-Oct-2002   EP 1 443 912   29-Aug-2007  
11-Oct-2022 Bulgaria     EPC   Granted   02800993.4   11-Oct-2002   EP 1 443 912
    11-Oct-2022 Canada     PCT   Granted   2,463,495   11-Oct-2002   2,463,495  
24-May-2011   11-Oct-2022 Cyprus, Republic of     EPC   Granted   02800993.4  
11-Oct-2002   EP 1 443 912   07-May-2010   11-Oct-2022 Czech Republic     EPC  
Granted   02800993.4   11-Oct-2002   EP 1 443 912     11-Oct-2022 Denmark    
EPC   Granted   02800993.4   11-Oct-2002   EP 1 443 912     11-Oct-2022 Estonia
    EPC   Granted   02800993.4   11-Oct-2002   EP 1 443 912     11-Oct-2022
European Patent Convention     PCT   Granted   02800993.4   11-Oct-2002   EP 1
443 912   29-Aug-2007   11-Oct-2022 Finland     EPC   Granted   02800993.4  
11-Oct-2002   EP 1 443 912     11-Oct-2022 France     EPC   Granted   02800993.4
  11-Oct-2002   EP 1 443 912     11-Oct-2022 Germany     EPC   Granted  
02800993.4   11-Oct-2002   60222160.9     11-Oct-2022

 

16

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Greece EPC Granted 02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Ireland EPC
Granted 02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Italy EPC Granted
02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Japan 3 DIV Published
2013-126534 11-Oct-2002 Luxembourg EPC Granted 02800993.4 11-Oct-2002 EP 1 443
912 11-Oct-2022 Monaco EPC Granted 02800993.4 11-Oct-2002 EP 1 443 912
11-Oct-2022 Netherlands EPC Granted 02800993.4 11-Oct-2002 EP 1 443 912
11-Oct-2022 Portugal EPC Granted 02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022
Slovakia EPC Granted 02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Spain EPC
Granted 02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Sweden EPC Granted
02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Switzerland EPC Granted
02800993.4 11-Oct-2002 EP 1 443 912 11-Oct-2022 Turkey EPC Granted 02800993.4
11-Oct-2002 EP 1 443 912 11-Oct-2022 United Kingdom EPC Granted 02800993.4
11-Oct-2002 EP 1 443 912 11-Oct-2022

 

17

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-2

Nanotechnology Patents

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry
Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

 

18

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry

Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry

Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent No.

 

Normal Expiry

Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

 

19

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry

Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

 

20

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-3

OCR Patents

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry
Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

[* * *]

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry
Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

 

21

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-4

Zogenix Patents

A-4.1 “Multiparticulate Modified Release Composition” (hydrocodone ER) - US

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry
Date

02.1816E.US   CON   United States   09/566,636   08-May-2000   Granted   6228398
  1-Nov-2019 02.1816E.US   CON3   United States   10/331,754   30-Dec-2002  
Granted   6902742   1-Nov-2019 02.1816E.US   CIP   United States   11/372,857  
10-Mar-2006   Pending   2006-0240105   1-Nov-2019

 

22

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-5

Palladin Patents

A-5.1 “Multiparticulate Modified Release Composition” (hydrocodone ER) - Canada

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry
Date

04.1816E.CA   PCT   Canada   2348871   01-Nov-1999   Granted   2348871  
1-Nov-2019

 

23

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A-6

Abuse Resistant Patents

[* * *]

 

APIL Ref.

 

Case Type

 

Country

 

Application No.

 

Filing Date

 

Status

 

Patent /

Publication No.

 

Normal Expiry
Date

[* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]   [* * *]

 

24

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit B-1

Transferred Trademarks

B-1.1 “VERELAN”

 

APIL Ref.

 

Trademark

 

Country /

Territory

 

Application No.

 

Filing Date

 

Registration No.

 

Registration

Date

TM.0039.US   VERELAN   United States   73/760,372   28-Oct-1988   1551582  
15-Aug-1989 TM.0039.CA   VERELAN   Canada   670059   07-Nov-1990   TMA 443175  
26-May-1995 TM.0039.KR   VERELAN   South Korea   185382   14-Dec-1989  
40-0185382   14-Dec-1989 TM.0039.TW-2   VERELAN   Taiwan   97047657  
15-Oct-2008   01367514   01-Jul-2009

 

25

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit B-2

Licensed Trademarks

B-2.1 “NANOCRYSTAL”

 

APIL Ref.

 

Trademark

 

Country /

Territory

 

Application No.

 

Filing Date

 

Registration No.

 

Registration

Date

TM.0001.US-1   NANOCRYSTAL   United States   75/425,869   29-Jan-1998   2492925
  25-Sep-2001 TM.0001.US-2   NANOCRYSTAL   United States   75/425,872  
29-Jan-1998   2386089   12-Sep-2000 TM.0001.CA   NANOCRYSTAL   Canada   732238  
30-Jun-1993   TMA 504715   27-Nov-1998 TM.0001.CTM   NANOCRYSTAL   European
Union   000885079   22-Jul-1998   000885079   12-May-2000 TM.0001.JP-1  
NANOCRYSTAL   Japan   63822/98   29-Jul-1998   4398178   07-Jul-2000
TM.0001.JP-2   NANOCRYSTAL   Japan   H10-071844   25-Aug-1998   4374459  
07-Apr-2000 TM.001.JP-3   NANOCRYSTAL   Japan   105670199   19-Nov-1999  
4428472   27-Oct-2000

B-2.2 “SODAS”

 

APIL Ref.

 

Trademark

 

Country /

Territory

 

Application No.

 

Application

Date

 

Registration No.

 

Registration

Date

TM.0015.US   SODAS   United States   78/127,040   08-May-2002   2794607  
16-Dec-2003 TM.0015.AR   SODAS   Argentina   2058068   29-Mar-1999  
1724388 [2365412]   30-Oct-1999 TM.0015.CA   SODAS   Canada   1006507  
24-Feb-1999   TMA 531496   21-Aug-2000 TM.0015.CTM   SODAS   European Union  
0002012953   21-Dec-2000   0002012953   02-Apr-2002 TM.0015.IE   SODAS   Ireland
  3290/87   25-Sep-1987   125699   25-Sep-1987

 

26

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

B-2.3 “CODAS”

 

Country /

Territory

 

Trademark

 

ALKS Ref

 

Application No

 

Registration

No.

 

Status

 

Filing Date

 

Registration

Date

United States
of America   CODAS   TM.0013.US   78538974   3591236   Registered   28-Dec-2004
  17-Mar-2009

B-2.4 “BeadTek”

 

Trademark

 

ALKS Ref

 

Application

No

 

Registration No.

 

Status

 

Country /

Territory

 

Filing Date

 

Registration

Date

BEADTEK   TM.0202.US   86452063   —     Pending   United States   12-Nov-2014  
—   BEADTEK
(design)       86530165   —     Pending   United States   10 Feb 2015   —  

 

27

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit C

Transferred License and Settlement Agreements

[* * *]

 

28

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit D to Agreement

Earn-Out Consideration

 

  ARTICLE 1 Definitions.

The following terms shall have the following meaning for this Exhibit D; and
terms used, but not defined in this Exhibit D, shall have the meanings set forth
in the remainder of the Agreement.

(a) “Ancillary Agreements” shall have the meaning set forth in the Purchase
Agreement.

(b) “Business Day” shall mean any day that is not a Saturday, a Sunday or other
day on which commercial banks in the City of New York, New York or Dublin,
Ireland are required or authorized by Law to be closed.

(c) “Closing” shall have the meaning set forth in the Purchase Agreement.

(d) “Commercially Reasonable Efforts” shall mean, with respect to the efforts to
be expended by Purchaser and its Affiliates, licensees and sublicensees with
respect to the Development Milestones and Commercial Milestones, reasonable,
diligent, good faith efforts to accomplish any such Development Milestones and
Commercial Milestones as is commonly used in the pharmaceutical industry
generally to accomplish a similar objective under similar circumstances, it
being understood and agreed that with respect to the research, development and
commercialization of any Earn-Out Product, such efforts shall be substantially
equivalent to those efforts and resources commonly used in the pharmaceutical
industry generally by a pharmaceutical company for a product owned by it or to
which it has rights, which product is at a similar stage in its development and
is of similar market potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative products in the marketplace, the
patent and other proprietary position of the product, the likelihood of
regulatory approval, the profitability and commercial potential of the product,
but without regard to any Earn-Out Consideration payable under this Exhibit D.

(e) “Divestiture” (and other correlative terms) shall mean any transaction in
which any Earn-Out Product or any intellectual property assets related to the
same are divested or transferred by any means, including by way of merger,
consolidation, asset acquisition or sale, license, sublicense, purchase, sale,
assignment or other similar transfer.

(f) “Earn-Out Consideration” shall mean, collectively, (i) Development Milestone
Earn-Out Consideration, (ii) Commercial Milestone Earn-Out Consideration, and
(iii) Net Sales Earn-Out Consideration.

(g) “Earn-Out Product Patents” shall mean (i) the Nanotechnology Patents,
(ii) the Meloxicam Transferred Patents, (iii) the OCR Patents and (iv) all
Patents of Purchaser and its Affiliates, licensors, licensees or sublicensees
that claim an Earn-Out Product or manufacture or use thereof, together with all
Patents that claim priority (in whole or in part, directly or indirectly) with
any of the foregoing of clauses (i), (ii), (iii) or (iv).

(h) “Earn-Out Products” shall mean (i) Meloxicam IV/IM, (ii) Meloxicam
Parenteral Formulation and (ii) any other product discovered or identified using
the Nanotechnology IP, the OCR IP or the Meloxicam Transferred Patents, and that
contains the same active pharmaceutical ingredient as Meloxicam IV/IM (including
any salts or other versions of such active pharmaceutical ingredient).

(i) “FDA” shall mean the United States Food and Drug Administration and any
successor agency thereto.

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(j) “First Commercial Sale” shall mean, on an Earn-Out Product-by-Earn-Out
Product and country-by-country basis, the first commercial sale in an arms’
length transaction of an Earn-Out Product to a Third Party by Purchaser or any
of its Affiliates, licensees or sublicensees in such country following
Regulatory Approval of such Earn-Out Product in such country.

(k) “GAAP” shall mean generally accepted accounting principles in the United
States.

(l) “Governmental Entity” shall mean any court, administrative agency,
commission or other governmental authority, body or instrumentality, federal,
state, local, domestic or foreign governmental or regulatory authority.

(m) “IND” shall mean an investigational new drug application filed with the FDA,
the competent authorities of a European Union member state, or equivalents in
other countries or regulatory jurisdictions for authorization to commence
clinical studies of a pharmaceutical product.

(n) “Know-How” shall mean all proprietary data, information, knowledge,
know-how, inventions, discoveries, trade secrets, processes, techniques,
strategies, methods, practices, skills, experience, documents, apparatus,
devices, assays, screens, databases (including safety databases), database
structures and data analysis methods, compositions, materials, methods,
formulas, improvements, clinical and non-clinical study reports, test data
including pharmacological, biological, chemical, biochemical, toxicological, and
clinical test data, analytical and quality control data, stability data, studies
and procedures.

(o) “Law” shall mean any United States federal, state or local, or any
non-United States law, statute, ordinance, rule, regulation, judgment, order,
injunction, decree, arbitration award, agency requirement, license or permit of
any Governmental Entity.

(p) “Liens” shall mean all liens, pledges, mortgages, charges, claims, security
interests, restrictions on transfer, encroachments or encumbrance, but not
including any license(s) of Transferred IP.

(q) “MAA” shall mean a Marketing Authorization Application as defined in EU
Directive 2001/83/EC and EU Regulation (EC) No. 726/2004.

(r) “Meloxicam Transferred Patents” shall mean the Transferred Patents with
respect to the patents and patent applications listed in subsections A-1.1,
A-1.2 and A-1.3 of Exhibit A-1.

(s) “NDA” shall mean a New Drug Application or Supplemental New Drug Application
filed with the FDA.

(t) “Net Sales” shall mean, consistent with GAAP:

(i) Subject to clause (ii) of this definition, the aggregate gross amount
invoiced to unrelated Third Parties by Purchaser, its Affiliates, its licensees
and its sublicensees for the sale of Earn-Out Products, less to the extent
applicable to such sale: (A) trade, cash and quantity discounts, if any,
actually accrued or paid; (B) credits, allowances and adjustments actually
accrued or paid to customers, including credits for rejected or returned
Earn-Out Products previously sold; (C) freight, insurance and other
transportation costs actually accrued or paid, to the extent separately
identified on the invoice; (D) rebates or reimbursements actually accrued or
paid to managed health care organizations, national, federal, state, or local
governments (or their agencies), and managed health organizations (including
Medicaid rebates), and (E) taxes, including value added taxes (VAT) (other than
taxes on Purchaser’s, its Affiliates’, its licensees’ or its sublicensees’
income), customs duties or other governmental charges on sales or use actually
paid by Purchaser, its Affiliates, its licensees or its sublicensees with
respect to the sale of such Earn-Out Products. No fines, penalties or comparable
payments to national, federal, state, or local governments (or their agencies)
or to other third parties shall be deductible from Net Sales.

 

30

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(ii) Sales between Purchaser, its Affiliates, its licensees or its sublicensees
shall be disregarded for the purposes of calculating Net Sales as long as the
Earn-Out Products are (A) resold to an unrelated Third Party in which case the
final sale to such unrelated Third Party shall be included in Net Sales or
(B) transferred or disposed of by Purchaser, its Affiliates, its licensees or
its sublicensees for a purpose specified in clause (i) of this definition.
Transfers or dispositions of Earn-Out Products, where on a non-profit basis and
in line with normal industry practice, (1) for charitable purposes; (2) for
preclinical, clinical trial, or non-commercial manufacturing purposes; or
(3) for regulatory or governmental purposes shall not in each case be deemed
“sales” for the purposes of calculating Net Sales. In addition, transfers or
dispositions of free promotional samples of Earn-Out Products in line with
normal industry practice shall not be deemed “sales” for the purposes of
calculating Net Sales. Otherwise, for the purposes of calculating Net Sales, a
“sale” shall include any transfer or other disposition of any Earn-Out Product
for consideration.

With respect to sales of Earn-Out Products invoiced in U.S. dollars, Net Sales
shall be determined in U.S. dollars. With respect to sales of Earn-Out Products
invoiced in a currency other than U.S. dollars, Net Sales shall be determined by
converting the currencies in which the sales are made into U.S. dollars, at
rates of exchange determined in a manner consistent with Purchaser’s, its
Affiliates’, its licensees’ or its sublicensees’, as applicable, method for
calculating rates of exchange in the preparation of such entity’s annual
financial statements in accordance with GAAP consistently applied. No amount for
which deduction is permitted pursuant to this definition shall be deducted more
than once.

(u) “Net Sales Earn-Out Consideration Term” shall mean, on an Earn-Out
Product-by-Earn-Out Product and country-by-country basis, the period of time
commencing upon the First Commercial Sale of an Earn-Out Product and ending upon
the later of (i) the fifteenth (15th) anniversary of the First Commercial Sale
of such Earn-Out Product in such country, and (ii) the date of the last to
expire Valid Claim of an Earn-Out Product Patent covering such Earn-Out Product
in such country.

(v) “Patents” shall mean any and all patents and patent applications (which for
purposes of this Agreement shall include certificates of invention and
applications for such certificates), including any divisionals, continuations,
continuations-in-part, substitutions, reissues, re-examinations, revalidations,
extensions (including pediatric exclusivity patent extensions), registrations,
supplementary protection certificates, renewals, and foreign equivalents of any
such patents or patent applications.

(w) “Person” shall mean a person, corporation, partnership, limited liability
company, joint venture, trust or other entity or organization.

(x) “Regulatory Approval” shall mean, with respect to a country or
extra-national territory, all approvals, licenses, registrations or
authorizations of any Regulatory Authority necessary in order to commercially
distribute, sell or market a drug product in such country or some or all of such
extra-national territory.

(y) “Regulatory Authority” shall mean any supra-national, federal, national,
regional, state, provincial or local governmental regulatory agencies,
departments, bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the development,
manufacture and commercialization of drug products, including the FDA.

(z) “Regulatory Materials” shall mean regulatory applications, submissions,
notifications, registrations, or other filings made to or with a Regulatory
Authority that are necessary or reasonably desirable in order to develop,
manufacture, market, sell or otherwise commercialize a product in a particular
country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs and
NDAs (as applications, but not the approvals with respect thereto).

(aa) “Third Party” shall mean, as of any relevant time, any Person who is not an
Affiliate of Purchaser.

 

31

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(bb) “United States” or “U.S.” shall mean the United States of America,
including its territories and possessions, the District of Columbia and Puerto
Rico.

(cc) “Valid Claim” shall mean a claim of an issued or pending Patent which claim
(i) in the case of an issued Patent, has not been found to be unpatentable,
invalid or unenforceable by a court or other authority of competent
jurisdiction, from which decision no appeal is taken or can be taken and which
otherwise has not been dedicated to the public or finally disclaimed, and
(ii) in the case of a pending Patent, a Valid Claim shall not include a claim in
a pending Patent that has a filing date or an earliest claimed priority date
that is more than five (5) years prior to the date upon which pendency of the
pending Patent is determined.

Definitions for each of the following terms are found in this Exhibit D as
indicated below:

 

Defined Term

  

Location

Assigned Reversion IP Assets    Section 4.2(c) Assigned Reversion Know-How   
Section 4.2(c) Assigned Reversion Patents    Section 4.2(c) Challenge Period   
Section 4.1(b) Commercial Milestone Earn-Out Consideration    Section 2.1(b)(i)
Commercial Milestones    Section 2.1(b)(i) Cure Period    Section 4.1(c)
Development Milestone Earn-Out Consideration    Section 2.1(a)(i) Development
Milestones    Section 2.1(a)(i) Disagreement Notice    Section 4.1(b) Divested
Assets    Section 2.4 NDA Requirement    Section 3.1 Net Sales Earn-Out
Consideration    Section 2.1(c)(i) Net Sales Report    Section 2.2 Reversion
Date    Section 4.1(d) Reversion Event    Section 4.1(a) Reversion Material   
Section 4.2(j) Reversion Notice    Section 4.1(b) Transferee    Section 2.4

 

  ARTICLE 2 Earn-Out Consideration.

2.1 Earn-Out Consideration.

(a) Development Milestone Earn-Out Consideration.

(i) The following amounts (“Development Milestone Earn-Out Consideration”) shall
be payable in accordance with Section 5 of the Agreement and this Exhibit D upon
achievement of the following events (“Development Milestones”) by Purchaser and
its Affiliates, licensees and sublicensees, and shall be non-refundable and
non-creditable and not subject to deduction or set-off:

 

Development Milestone

  

Amount of Development Milestone Earn-Out
Consideration (U.S. Dollars)

[* * *]

   $[* * *]

[* * *]

   $[* * *]

(ii) Purchaser shall notify and pay to APIL each Development Milestone Earn-Out
Consideration within thirty (30) calendar days after the occurrence of the
corresponding Development Milestone. Each such payment shall be made by wire
transfer of immediately available funds to such account or accounts as are
designated in writing by APIL.

 

32

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(b) Commercial Milestone Earn-Out Consideration.

(i) The following amounts (“Commercial Milestone Earn-Out Consideration”) shall
be payable in accordance with Section 5 of the Agreement and this Exhibit D
following the first calendar year during which the aggregate annual Net Sales of
Earn-Out Products by Purchaser and its Affiliates, licensees and sublicensees
first exceed the threshold amounts set forth in the table below (“Commercial
Milestones”), and shall be non-refundable and non-creditable and not subject to
deduction or set-off:

 

Commercial Milestones

  

Amount of Commercial Milestone Earn-Out
Consideration (U.S. Dollars)

$[* * *] in annual Net Sales

   $[* * *]

$[* * *] in annual Net Sales

   $[* * *]

$[* * *] in annual Net Sales

   $[* * *]

(ii) Purchaser shall notify and pay to APIL each Commercial Milestone Earn-Out
Consideration within thirty (30) calendar days after the end of the calendar
quarter in which the corresponding Commercial Milestone is achieved. Each such
payment shall be made by wire transfer of immediately available funds to such
account or accounts as are designated in writing by APIL.

(c) Net Sales Earn-Out Consideration.

(i) During the Net Sales Earn-Out Consideration Term, Purchaser shall pay in
accordance with Section 5 of the Agreement and this Exhibit D an amount of [* *
*] percent ([* * *]%) of the aggregate Net Sales of Earn-Out Products (“Net
Sales Earn-Out Consideration”), which amount shall be non-refundable and
non-creditable and not subject to deduction or set-off.

(ii) If, pursuant to Section 2.1(c)(i) of this Exhibit D, any Net Sales Earn-Out
Consideration is payable on Net Sales of an Earn-Out Product in the U.S. and
there is no Valid Claim of an Earn-Out Product Patent in the U.S. covering such
Earn-Out Product at the time of such sale, the percentage applicable to
calculate such Net Sales Earn-Out Consideration shall be reduced by thirty
percent (30%) from the percentage set forth in Section 2.1(c)(i) of this
Exhibit D.

2.2 Net Sales Reports. During the Net Sales Earn-Out Consideration Term,
(a) within five (5) Business Days after the end of each calendar quarter,
Purchaser shall provide an estimate of the Net Sales, on a Earn-Out
Product-by-Earn-Out Product and country-by-country basis, to APIL for the
preceding calendar quarter and (b) within forty-five (45) calendar days after
the end of each calendar quarter, Purchaser shall provide a sales report (“Net
Sales Report”), on a Earn-Out Product-by-Earn-Out Product and country-by-country
basis, to APIL showing a reconciliation of gross sales to Net Sales of each
Earn-Out Product during such calendar quarter reporting period (including the
related permitted deductions) and the Net Sales Earn-Out Consideration payable
with respect thereto. Purchaser shall pay to APIL the Net Sales Earn-Out
Consideration for each calendar quarter at the time of submission of the
corresponding Net Sales Report. If no Net Sales Earn-Out Consideration is due
for any period hereunder following commencement of the reporting obligation,
Purchaser shall so report.

2.3 Late Payments. If APIL does not receive payment of any sum due to them on or
before the due date, simple interest shall thereafter accrue on the sum due to
APIL until the date of payment at the per annum rate of two percent (2%) over
the then-current prime rate quoted by Citibank in New York City or the maximum
rate allowable by applicable Law, whichever is lower.

 

33

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2.4 Divestitures. If at any time after the Effective Date, Purchaser Divests to
a Third Party or an Affiliate any Earn-Out Product, Earn-Out Product Patent or
any other intellectual property asset related to an Earn-Out Product
(collectively, “Divested Assets” and the party receiving any Divested Assets the
“Transferee”), Purchaser shall: (a) make provision for the Transferee to assume
and succeed to the obligations of Purchaser set forth in this Exhibit D; and
(b) prior to or simultaneously with the consummation of any such Divestiture,
cause such Transferee to provide to APIL an instrument of assumption in a
reasonable form for the benefit of APIL effecting the assumption and succession
described in the foregoing Clause (a), and proof satisfactory to APIL of such
Transferee’s financial capacity to assume Purchaser’s obligations set forth in
this Exhibit D. Purchaser shall remain liable to APIL for all obligations set
forth in this Exhibit D following any such Divestiture.

 

  ARTICLE 3 Diligence; Reporting; Audit.

3.1 Diligence. Purchaser, itself or through one or more of its Affiliates,
licensees and sublicensees, shall use Commercially Reasonable Efforts to achieve
each of the Development Milestones and Commercial Milestones. Without limiting
the foregoing, Purchaser, itself or through one or more of its Affiliates,
licensees and sublicensees, shall file an NDA for an Earn-Out Product with the
FDA on or before [* * *] (the “NDA Requirement”).

3.2 Reporting.

(a) For so long as any Earn-Out Product is in development, on each anniversary
of the Effective Date, Purchaser shall provide a written report to APIL
detailing the development activities with respect to the Earn-Out Products
completed for the past annual reporting period and anticipated to be undertaken
for the next twelve (12) months period. At a minimum, such report shall include
a list and general status (i.e., what stage in discovery/development using
Purchaser’s internal measures) of each Earn-Out Product then in development, and
any ongoing pre-clinical or clinical activities (including initiations and
cessations) and results, and submission and approvals to or from Regulatory
Authorities (including anticipated date of achievement of the Development
Milestones), and any other similar information relating to development
activities for the Earn-Out Products. Purchaser shall cause its senior officers
from its research and clinical development operations to be reasonably available
to APIL to answer questions related to the matters required to be discussed in
each report.

(b) For so long as any Earn-Out Product is being marketed, sold, or otherwise
commercialized, within sixty (60) days of the end of each calendar quarter,
Purchaser shall provide a written report to APIL detailing the commercialization
efforts with respect to the Earn-Out Products completed for the past quarterly
reporting period and anticipated to be undertaken for the next calendar quarter
and for the three (3) calendar quarters thereafter. At a minimum, such report
shall include with respect to the commercialized Earn Out Products marketing and
sales efforts, forecasted sales, pricing changes, anticipated date of
achievement of the Commercial Milestones, and any other similar information
relating to commercialization activities for the Earn-Out Products. Purchaser
shall cause its senior officers from business operations to be reasonably
available to APIL to answer questions related to the matters required to be
discussed in each report.

3.3 Audit. Purchaser shall maintain, and shall cause its Affiliates, licensees
and sublicensees to maintain, complete and accurate books and records in
sufficient detail to permit APIL, at its expense, to confirm the achievement of
Development Milestones and Commercial Milestones, and the calculation of
Earn-Out Consideration payable under this Agreement and this Exhibit D. Upon
reasonable prior notice, such books and records shall be open during regular
business hours for a period of three (3) years from the creation of individual
books and records for examination, by an independent certified public accountant
selected by APIL and reasonably acceptable to Purchaser for the sole purpose of
verifying for APIL the accuracy of the financial statements, reports and notices
furnished by Purchaser pursuant to this Agreement and this Exhibit D, and of any
payments made, or required to be made, by Purchaser to APIL pursuant to this
Agreement and this Exhibit D. Any amounts shown to be owed to APIL but unpaid
shall be paid by Purchaser within thirty (30) days after the accountant’s
report, plus interest (as set forth in Section 2.3 of this Exhibit D) from the
original due date. If Purchaser is found to have

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

underpaid amounts owed to APIL by five percent (5%) or more, then Purchaser
shall also pay for the conduct of the audit. In the event that Purchaser has
overpaid APIL, at APIL’s option, Purchaser shall either credit the amount of any
such overpayment to amounts subsequently due by Purchaser to APIL under this
Exhibit D or APIL shall reimburse Purchaser the amount of any such overpayment.

 

  ARTICLE 4 Reversion.

4.1 Determination of Reversion Event.

(a) A “Reversion Event” shall exist in the event that Purchaser, itself or
through one or more of its Affiliates, licensees and sublicensees, (i) fails to
satisfy the NDA Requirement, or (ii) in the reasonable judgment of APIL, fails
to comply with its Commercially Reasonable Efforts requirements under
Section 3.1 of this Exhibit D; provided that, any such failure is not
attributable to the material breach by APIL or any of its Affiliates of any of
the Ancillary Agreements, which material breach was noticed by Purchaser prior
to its receipt of a Reversion Notice from APIL under this Section 4.1.

(A) In the event the failure to satisfy the NDA Requirement is the result of a
change in the FDA’s policies or procedures regarding the approval of the
Earn-Out Product or drugs in the same class as the Earn-Out Product, and
Purchaser, its Affiliates, licensees or sublicensees have used Commercially
Reasonable Efforts to accommodate such change and were still unable to satisfy
the NDA Requirement, then the deadline shall be extended for a reasonable period
of time, but not more than three-hundred sixty-five (365) calendar days or such
longer period of time as determined by APIL in good faith based on the impact of
such change in the FDA’s policies or procedures on their ability to accommodate
such change in policies or procedures. (B) In the event the failure to satisfy
the NDA Requirement is the result of other delays or circumstances that are
outside of the reasonable control of Purchaser or its Affiliates, licensees and
sublicensees, and Purchaser, its Affiliates, licensees or sublicensees have used
Commercially Reasonable Efforts consistent with Section 3.1 of this Exhibit D to
overcome such delay or circumstance, then APIL will reasonably consider
extending the deadline for a reasonable period of time, but not more than
three-hundred sixty-five (365) days, to overcome such failure. In each case of
(A) or (B), the compliance with such new deadline shall remain an obligation of
Purchaser, its Affiliates, licensees or sublicensees subject to their diligence
efforts under Section 3.1 of this Exhibit D and APIL’s rights under this
Section 4.1(a).

(b) Upon a Reversion Event, APIL shall provide Purchaser with written notice of
such Reversion Event (a “Reversion Notice”). If Purchaser disagrees with APIL
regarding the existence of a Reversion Event, it shall notify APIL within ten
(10) Business Days of receipt of a Reversion Notice of its disagreement (such
period, the “Challenge Period,” and such notice, a “Disagreement Notice”). For a
period of thirty (30) Business Days following the delivery of such Disagreement
Notice, Purchaser and APIL shall seek in good faith to come to an agreement on
the existence of the Reversion Event. If at the end of such thirty (30) Business
Day period Purchaser and APIL have not reached an agreement, they shall jointly
select an independent mediator, free of any conflict with either party, having
the requisite licensing and pharmaceutical industry experience to render a
decision regarding the existence of a Reversion Event, and selected from a panel
of persons experienced in the pharmaceutical and life sciences industries
provided by Judicial Administration and Arbitration Services or its successor
(“JAMS”). If the parties do not agree on an independent mediator within five
(5) Business Days of initiating mediation under this Section 4.1(b), the
independent mediator shall be selected by JAMS in accordance with its rules.
Each party shall prepare and submit a written summary of such party’s position,
which shall not exceed twenty-five (25) pages, and any relevant evidence in
support thereof to the independent mediator within ten (10) Business Days of the
selection of the independent mediator. Upon receipt of such summaries from both
parties, the independent mediator shall provide copies of the same to the other
party. The independent mediator shall be authorized to solicit briefing or other
submissions on particular questions and to set specific page limits for such
additional briefing and submissions. Within five (5) Business Days of the
delivery of such summaries by the independent mediator, each party shall submit
a written rebuttal of the other party’s summary and may also amend and re-submit
its original summary, with each party’s response to include a supporting
explanation of why its

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

proposed terms are more appropriate than the other party’s proposed terms and
any documentary evidence in support thereof. Oral presentations shall not be
permitted unless otherwise requested by the independent mediator. Only if so
permitted, a neutral location of any such oral presentations shall be selected
by the independent mediator. The independent mediator shall make a final
decision with respect to the arbitration matter within ten (10) Business Days
following receipt of the last of such rebuttal statements submitted by the
parties, and shall make a determination by selecting the resolution proposed by
one of the parties that as a whole is the most fair and reasonable to the
parties in light of the totality of the circumstances, and shall provide the
parties with a written statement setting forth the basis of the determination in
connection therewith. For clarity, the independent mediator shall only have the
right to select a resolution proposed by one of the parties in its entirety and
without modification. The decision of the independent mediator shall be
controlling regarding the existence of a Reversion Event. Purchaser and APIL
shall bear the costs of the independent mediator equally.

(c) If the existence of a Reversion Event, other than one that involves a
failure to satisfy the NDA Requirement, is confirmed, through (i) Purchaser’s
non-delivery of a Notice of Disagreement or (ii) through the determination of an
independent mediator, Purchaser, itself or through one or more of its
Affiliates, licensees or sublicensees shall have the right to cure such
Reversion Event for a period of four (4) months from the determination of such
Reversion Event (such period, the “Cure Period”) and, if it elects to exercise
such right, shall notify APIL in writing of the same. In the case that such
Reversion Event is cured in APIL’s reasonable judgment during or by the end of
the Cure Period, such Reversion Event shall no longer exist and APIL shall not
have the right to invoke any other rights under this Article 4 in connection
with such event that would have remained a Reversion Event but for such cure.

(d) For purposes of this Article 4, the “Reversion Date” shall be (i) the date
on which the Challenge Period expires without Purchaser having sent a
Disagreement Notice to APIL, unless the Reversion Event at issue qualifies for a
right to cure pursuant to Section 4.1(c) of this Exhibit E and Purchaser has
elected to exercise such right to cure in which case clause (d)(iii) below shall
apply, (ii) where the Reversion Event involves a failure to satisfy the NDA
Requirement and Purchaser has sent a Disagreement Notice in connection
therewith, the date on which the parties agree, or the independent mediator
issues its determination, that such Reversion Event has occurred, or (iii) where
the Reversion Event does not involve a failure to satisfy the NDA Requirement,
and Purchaser has elected its right to cure pursuant to Section 4.1(c) of this
Exhibit D, the date on which the Cure Period expires without Purchaser having
cured such Reversion Event to APIL’s reasonable satisfaction.

4.2 Events Upon Determination of a Reversion Event.

(a) On the Reversion Date, all licenses and other rights of Purchaser and its
Affiliates, licensees and sublicensees under this Agreement (i) with respect to
the Nanotechnology IP shall automatically terminate in their entirety, and
(ii) with respect to the OCR IP shall automatically terminate solely in regards
to the Earn-Out Products.

(b) As of the Reversion Date, but subject to Sections 4.2(h), 4.2(i) and 4.2(j),
Purchaser, and its Affiliates, licensees and sublicensees shall cease all
research, development, manufacture, sales, offers to sell, use, importation and
commercialization of the Earn-Out Products.

(c) Promptly following the Reversion Date, Purchaser shall (i) assign to APIL
the Meloxicam Transferred Patents and any other Patents owned or controlled by
it and its Affiliates, licensees or sublicensees solely relating to the Earn-Out
Products (collectively, the “Assigned Reversion Patents”), and (ii) transfer to
APIL all Know-How owned or controlled by it and its Affiliates, licensees or
sublicensees solely relating to the Earn-Out Products (the “Assigned Reversion
Know-How” and together with the Assigned Reversion Patents, the “Assigned
Reversion IP Assets”).

(d) As of the Reversion Date, Purchaser grants to APIL a non-exclusive,
worldwide license (sublicenseable through multiple tiers) under all Patents and
Know-How owned or controlled by Purchaser and its

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Affiliates, licensees or sublicensees (other than Assigned Reversion Patents and
Assigned Reversion Know-How) that are practiced by or on behalf of Purchaser and
its Affiliates, licensees and sublicensees as of the Reversion Date that are
necessary or useful to research, develop, manufacture, sell, offer to sell, use,
import or otherwise commercialize any of the Earn-Out Products.

(e) Promptly following the Reversion Date, Purchaser shall assign to APIL all
right, title and interest in and to those trademarks used exclusively with the
Earn-Out Products, excluding any such trademarks that include, in whole or part,
any corporate name or logo of Purchaser or its Affiliates.

(f) Promptly following the Reversion Date, Purchaser shall (i) transfer and
assign to APIL all Regulatory Materials and Regulatory Approvals relating to the
Earn-Out Products, or, if not possible, grant to APIL an exclusive right of
reference thereunder.

(g) To the extent that any payments would be owed by Purchaser to any Third
Party under any agreement with such Third Party that is applicable to the
exercise by APIL of any (sub)license, right of reference or other right provided
in this Section 4.1, Purchaser shall notify APIL of the existence and
anticipated amounts of such payments and APIL shall have the right either to
decline such (sub)license, right of reference or other right provided in this
Section 4.1 or to take the same, in which case APIL agrees to comply with any
obligations under such agreement of Purchaser that apply to APIL and of which
APIL was informed by Purchaser and to make such payments.

(h) Promptly following the Reversion Date and as requested by APIL, Purchaser
shall, and shall cause its Affiliates, licensees and sublicensees to, (i) wind
up the performance of any clinical trials for Earn-Out Products ongoing as of
the Reversion Date, or (ii) transfer and assign to APIL, to the extent
assignable by Purchaser in accordance with applicable Law, the management and
continued performance of any clinical trials for Earn-Out Products ongoing as of
the Reversion Date (provided that if the management and continued performance
thereof is not assignable, then at the request of APIL, Purchaser shall, and
shall cause its Affiliates, licensees and sublicensees to, continue to manage
and perform such clinical trial(s) for a limited time period at the direction of
APIL) the reasonable and documented out-of-pocket cost of which that is incurred
after the Reversion Date shall be borne by APIL.

(i) Promptly following the Reversion Date and as requested by APIL, Purchaser
shall assign to APIL any agreements with third party suppliers covering the
supply or sale of the Earn-Out Products, or, if such agreements cover other
products or do not permit assignment under their terms, then, to enable APIL to
qualify an alternate, validated source of supply, Purchaser shall supply
finished Earn-Out Products for a reasonable period (not to exceed six
(6) months) and at a cost equal to the cost of goods for any such Earn-Out
Product calculated in accordance with industry standards (including overhead)
plus [* * *].

(j) As of the Reversion Date, if Purchaser or any of its and its Affiliates,
licensees or sublicensees have any inventory of Earn-Out Product, or any
components thereof, suitable for use in clinical trials or for commercialization
(“Reversion Material”), Purchaser and its Affiliates, licensees and sublicensees
shall offer in writing to sell the Reversion Material to APIL at Purchaser’s or
the applicable Affiliate’s, licensee’s or sublicensee’s fully-allocated cost of
manufacturing, and APIL shall have the option (but no obligation) to purchase
the same by responding in writing to such offer within thirty (30) days. If APIL
does not exercise such option, Purchaser and its Affiliates, licensees or
sublicensees shall be entitled to sell any such Reversion Material, subject to
any Earn-Out Consideration applicable to such sale pursuant to the terms and
conditions of this Exhibit D.

4.3 Without limiting the generality of this Article 4, any assignment, transfer,
license or other right made or granted to APIL pursuant to this Article 4 shall
be effected without any consideration payable by APIL.

 

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EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4.4 Without limiting the generality of this Article 4, following the assignment
and transfer under Section 4.2(c), (a) Purchaser shall have no right to use any
of the Assigned Reversion IP Assets; (b) APIL shall have at its expense the sole
and exclusive right to prosecute, maintain, defend and enforce all Assigned
Reversion Patents assigned to APIL pursuant to such Section 4.2(c), and for
purposes of all those activities, (i) APIL shall be treated as the owner of such
Assigned Reversion Patents, and shall be solely responsible for the costs
associated with such activities and shall have the sole right to retain any and
all recoveries resulting from such activities, and (ii) to the extent required
by applicable Law, at the cost of APIL, Purchaser shall, and shall cause each of
its Affiliates, licensees and sublicensees to, join any suit or proceeding
regarding any such Assigned Reversion Patents, or designate APIL (or an
Affiliate thereof) as such party’s authorized agent for such Assigned Reversion
Patents.

4.5 Purchaser shall ensure that Purchaser receives from any of its licensees and
sublicensees all rights necessary for Purchaser to effectuate the assignments
and transfers to APIL and to grant to APIL the rights and licenses set forth in
this Article 4.

4.6 Purchaser shall not, and shall ensure that its Affiliates shall not, grant
any Lien in or to any Assigned Reversion IP Assets, or take any action or commit
any omission that may adversely affect or in any way impair, interfere with or
prevent APIL’s right to receive the benefit of the assignments, transfers and
licenses granted under this Article 4.

4.7 The right of reversion hereunder shall be APIL’s sole and exclusive remedy
for Purchaser’s failure to satisfy the NDA Requirement or failure to comply with
its Commercially Reasonable Efforts requirements under Section 3.1 of this
Exhibit D, provided the foregoing shall in no way limit APIL’s right to collect
and be paid any Earn-Out Consideration based on Development Milestones or
Commercial Milestones achieved as of the Reversion Date, or on sales of the
Earn-Out Products prior to the Reversion Date or permitted thereafter pursuant
to Section 4.2(j).

 

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